Stanislaw Burzynski gets off on a technicality

NOTE: Special thanks to Jann Bellamy for advising me regarding the legal aspects of this post.

There are times when I fear that I'm writing about the same topic too many times in too brief a period of time. Most commonly, I notice this concern when writing about the lunacy of the anti-vaccine movement. In fact, it's fairly rare that I feel it for any other topic. There is, however, one topic other than antivaccinationist assaults against science and reason that will sometimes obligate me to go on a roll such that I might write multiple posts in a short period of time. I'm referring, of course, to the dubious doctor known as Stanislaw Burzynski, a man who charges desperate patients with advanced (and usually incurable) cancer tens and even hundreds of thousands of dollars to participate in his "clinical trials" of antineoplastons, compounds that he claims to have isolated from urine and that he now represents as a promising new treatment that can do much better than existing therapies with much less toxicity, even though there's no evidence that it can. He's even starred in his very own documentary, which his very own propagandist Eric Merola, used as a paean to the greatness that Burzynski obviously considers himself to possess. The documentary was awful, full of biased misinformation and overall just a plain bad movie. Lately, Burzynski has been claiming to use what he refers to as "personalized gene-targeted cancer therapy," which is more appropriately described as "personalized therapy for dummies," given how incompetently it is carried out and the manner in which Burzynski mixes and matches very expensive targeted therapy and chemotherapy in ways guaranteed to produce synergistic toxicity.

Through it all, Burzynski collects huge fees for his "services," motivating the desperate families of dying cancer patients to hold massive fundraisers. This sort of story has become a depressingly common topic for this blog over the last year since I really started to notice Burzynski and his followers in a big way. Most recently it was Rachael Mackey and Amelia Saunders. Before that, it was a parade of children and adults that included Brynlin Sanders, Jesse Bessant, Shana Pulkinen, Billie Bainbridge, Kelli Richmond, and Olivia Bianco. There are more, so many more, but they all share two things in common. First, Stanislaw Burzynski failed them, and, second, they made the news because they held fundraisers to try to pay the tens and hundreds of thousands of dollars that Burzynski charges for his services. Meanwhile, although Burzynski somehow has a phase 3 clinical trial that was apparently approved by the FDA (although it hasn't accrued a single patient in nearly two years), the FDA has slapped him down for serious problems with the institutional review board (IRB) that oversees his "clinical trials" and for making claims for his antineoplastons even though they are not FDA-approved.

Unfortunately, as I noted last week, although the Texas Medical Board (TMB) brought action against Burzynski to strip him of his medical license, it appears that he he will slither away yet again, given that the proceedings against him have apparently been dismissed. At the time I took note of this development, I didn't know how Burzynski had managed to slither away from accountability for his actions and justice yet again. Certainly, the gloating by the likes of Patrick "Tim" Bolen shed no light on the question, nor did this triumphant screed by someone who calls herself Sarah the Healthy Economist:

Why has Dr. Burzynski been so relentlessly persecuted first by the United States Government and then the Texas Medical Board for so many years?

Follow the money my friends!

The multi-agent gene targeted therapy called Antineoplastons is a nothing short of a huge medical breakthrough that promises to completely shatter the cut, poison, burn Standard Of Care – surgery, chemotherapy and radiation treatment. When clinical trials are completed and Antineoplastons approved, it will be the first time in history that a single individual and not a pharmaceutical company holds the exclusive patent to manufacture and distribute these gene targeted medicines on the open market.

Uh, no. Antineoplastons don't represent "multi-agent gene targeted therapy." The person who wrote this bit of gloating is clearly too ignorant of what Burzynski actually does and claims to know that the "gene-targeted" therapy he claims to provide is not antineoplastons (although Burzynski somehow manages always to include antineoplastons in his concoctions). Nor is what Burzynski does anything that will "completely shatter" the current cancer treatment paradigm.

None of this stops the hyperbole, though:

Parents have particular reason to rejoice that the case against Dr. Burzynski has been dismissed. One form of childhood cancer – diffuse, intrinsic, childhood brainstem glioma for which conventional medicine has no cure has been cured by Antineoplastons (with dozens of others). [ANP - PubMed 2003] [ANP - PubMed 2006] [ANP - Cancer Therapy 2007] [Rad & other - PubMed 2008] [Chemo/Rad - PubMed 2005]

Congratulations Dr. Burzynski on this huge win against the foes that are attempting to silence you and stop your amazing work. The road ahead is still long until treatment with Antineoplastons is widely available to all Americans, but this recent victory brings a big one home for the little guy!

No, it's not. It is, unfortunately, a victory for a man who uses the desperation of dying cancer patients to extract huge sums of money from them or, as one of his patients put it, to use them "as an ATM" and coercing her into buying her prescriptions from a Burzynski-owned pharmacy at "outrageous" prices. Meanwhile, the heart of the case brought against Burzynski brought by the TMB was his off-label use of targeted therapies in treating cancer patients. When I last reviewed this, I was astounded at the number of targeted drugs in the drug cocktails used. Not only was Burzynski using chemotherapy and a lot of it, but he was using some very expensive products of big pharma in a medically unsupportable manner. So let's head over to the actual legal rulings. I do this, of course, with a bit of trepidation because, of course, I'm not a lawyer. However, even not being a lawyer, I think the reasons for the dismissal become fairly obvious by reading some of the motions and rulings. Plus I had input from a real lawyer.

So why was Buryznski's case dismissed? Fortunately, some of my readers helped me out in the comments of my last post. You, too, can get these PDFs if you wish, just by going to the Texas State Office of Administrative Hearings (SOAH) and, using a guest account, searching for docket 503-11-1669. The "money filings" are ORDER NO. 12 - RULING ON RESPONDENTS MOTION FOR DISPOSITION, STAFFS SPECIAL EXCEPTIONS, AND MEMORIALIZING PARTIES STIPULATION OF FACTS and ORDER N O. 16 » GRANTING AND DENYING IN PART STAFFS MOTION FOR RECONSIDERTION OF ORDER NO. 12. Basically, the TMB had gone after Burzynski based on the doctrine of vicarious liability, which means in essence that the TMB was arguing that Burzynski was responsible for the actions of the physicians working for him who had cared for the patients at the heart of the TMB case against Burzynski. In response, Burzynski moved to dismiss and/or strike TMB allegations against him to the extent that the allegations were based on the actions of other physicians working at his clinic. His attorney's argument was that, under administrative law, there is no vicarious liability for the actions of others. This is apparently different from tort law (for example, medical malpractice), where the physician can be held liable for the actions fo physicians working under his control or supervision in some circumstances. The bottom line is that the administrative judge ruled in Burzynski's favor. From the RESPONDENT'S REPLY TO THE BOARD STAFF'S SUPPLEMENTAL RESPONSE ON THE CONSOLIDATE MOTION FOR DISMISSAL AND SUMMARY DISPOSITION:

Respondent's ownership of the clinic and his self-designation as the clinic's chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in "charge of treatment" (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.

The judge accepted this reasoning, which meant that the TMB faced the bad option of trying to prosecute a case based only on what the complaint alleged that Burzynski himself did. It's not clear why the TMB voluntarily dismissed the case after this ruling, but perhaps the TMB's lawyers concluded that there wasn't a strong enough case based only on the allegations against only Burzynski. Basically, by throwing his fellow physicians working for him under the bus, Burzynski walks. Why do I say "throwing them under the bus"? Simple. The TMB could, if it so desired, begin actions against the individual physicians who took care of these patients, and I sincerely hope that the TMB does just that.

As for the significance of the ruling, contrary to what Burzynski's apologists would like you to believe, this ruling says absolutely nothing about whether what Burzynski is doing is good science or not. It says exactly nothing about whether what Burzynski is doing is good medicine or not. It says even less about whether Burzynski's clinical trials are ethical or not. All the board found was that, as a matter of law, the TMB couldn't bring action against Burzynski on the basis of actions performed by doctors under his supervision. So when someone like Patrick "Tim" Bolen exults that Burzynski's somehow been vindicated, Sarah the Healthy Economist says "alternative cancer treatment wins big," or Burzynski's lawyer Richard Jaffe says something like, "The cutting-edge, multi-agent gene targeted therapy devised by Dr. Burzynski which was at the heart of this proceeding is still being given at the clinic and is helping countless patients," it's a non sequitur. Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski's work, nor does it in any way vindicate him. He got off on a technicality, and that's all.

That still leaves the claim by Jaffe that "two medical board informal settlement panels found that the use of these combination drugs on the advanced cancer patients involved was within the standard of care." Unfortunately, we have no way of finding out what the settlement panels did or didn't find because the proceedings of such panels are confidential, being as the name implies an attempt to see if the parties can settle the case prior to litigation. One notes that the board appears to have disagreed with Burzynski's characterization of the settlement proceedings.

I'm not going to lie or downplay it here. The dismissal of the TMB action against Burzynski is a major setback to efforts to stop what Burzynski is doing. He's now basically free to continue to do what he's been doing for the last thirty years. Once burned, it's unlikely that the TMB will take another crack at him any time soon. The last time it did was back in the 1990s. Will it be in the 2020s before a future board decides to try again, or will Burzynski retire or die before then, leaving his son Greg to carry on the family business?

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Thanks Orac (and Jann).

You've got to hand it to the sneaky old ba§tard, that's a clever ruse isn't it? Advertise your services as genius, persecuted medical maverick, lure victims patients into your clinic, and then never meet, see, or treat them. "Wasn't me your honour, I was at home rolling in $100 bills at the time".

I hope TMB goes for the treating physicians add goes hard at them. Burykidski will find it hard to operate a clinic sans patsies doctors.

And he'll also find it hard to recruit new doctors if it's known that working at the Burzynski Clinic could be a quick way to lose their licenses.

Let's see - "helped countless patients." Hmmm....kind of hard to judge since Dr. B hasn't published any of his trial results. In fact, all we hear about are the ones that seem to die.

Also, since his "drug cocktail" isn't scrutinized, he could be giving just about anything to these patients (especially since they buy the drugs from his pharmacy).

It is extremely scary that this guy is still allowed to practice (though because of the technicality, it doesn't seem that he is "treating" anyone).

Countless patients? Zero could be said to be countless, I suppose, in the convoluted logic that holds sway at that clinic.

IANAL, but I'm wondering if this technicality leaves Burzynski open to fraud charges. (Federal charges, since he is clearly operating across state lines.) He collects huge sums of money from patients who think he is treating them, but he is now on record in court as stating that he isn't the one doing the treating. Does somebody with a better knowledge of criminal law want to comment?

By Eric Lund (not verified) on 26 Nov 2012 #permalink

Could someone explain why the FDA or other entity can't, or won't shut him down?

But he is treating them - through his subordinate physicians. That's enough to get off the fraud issue, and also enough to buffer him from responsibility in regards to licensing. Isn't law nice?

The more I hear, the more disgusted I get.

I'll join you in hoping they go after his subordinates. I suspect once they tear down that shield against responsibility, Burzynski might be too greedy to stop and hopefully he'd get caught as soon as he did anything personally.

But I'd worry that he'd retire to his mansion and start writing books on how you, too, can fleece the terminally ill for profit.

By Bronze Dog (not verified) on 26 Nov 2012 #permalink

@ Bronze Dog:

I think that it's more likely that he'll write books about how his therapy can save the terminally ill because that's a way to channel them to his family business.

By Denice Walter (not verified) on 26 Nov 2012 #permalink

As far as I'm concerned: until Burzynski's shut down for good, Orac can't write often enough about him.

By Edith Prickly (not verified) on 26 Nov 2012 #permalink

@lsm

FDA doesn't regulate the practice of medicine. They can go after him for how he sells/promotes his unapproved drugs or how/whether he conducts clinical trials, but they can't do anything about his medical license or ability to practice medicine.

Once again, I suggest that folks write to PBS's Frontline to nudge them into doing an episode on him. Let's shine a light on the darkness, people!

@Todd W,
The problem with Frontline is that they would most likely take the "tell both sides" approach, which would give Dr. B plenty of chance to spin. What would best fit Dr. B is a Michael Moore- style documentary that would lay out the histories of the people the clinic failed to help. Another thing worth looking into is where all the online "testimonials" are coming from. That's clearly a huge part of how the clinic's business is being sustained. I would wager that if (BIG "if"!) that subcultural bubble could be burst, the clinic would collapse.

Another thing that's shaping up is that it looks more and more like it would be easier to get the clinic simply on fishy business practices than Burzynski on his medical practices. That would entail more agencies getting involved, and I'm not sure which ones.

David N. Brown
Mesa, Arizona
www.exotroopers.wordpress.com

By David N. Brown (not verified) on 26 Nov 2012 #permalink

It's my understanding that the most you can usually expect from charges such as these are a letter of admonition against the supervising license-holder. Spin value aside, this action may have throw some cold water on B's inner workings.

By LindaRosaRN (not verified) on 26 Nov 2012 #permalink

@ David N. Brown:

A BIG If indeed!
Dr B's fame ( infamy, actually) is unfortunately supported by alt media and woo-meisters far and wide who provide maintaintence of the sub-culture- simultaneously pushing worthless or dangerous woo and discrediting SBM.
If ONLY!

By Denice Walter (not verified) on 26 Nov 2012 #permalink

@David N. Brown

Frontline generally takes the following format:

First half: present the topic in a neutral light, from the POV of those promoting the issue.
Second half: apply a no-punches-pulled reality-based critique of said POV.

I've been impressed by how they've handled other controversial topics, like Facilitated Communication (Prisoners of Silence) and vaccines (The Vaccine Wars). No one who watches those would come away with any doubt as to the reality of the subject, other than via willful ignorance. I think they could do a very good job with Burzynski, showing what he claims and what actually goes on, with the very real (and very depressing) results.

That said, there's no reason why a multi-pronged approach could not be used.

@Todd W:
Sorry to ask something that may be obvious here, but I really want to know: why does the government/FDA let him get away with it? I know the FDA is under-funded/staffed, but it seems like his drug and clinical trial offenses is a gigantic pile of turd that would be easily actionable by the FDA, if not other entities. Who could pressure them? (and I agree with Edith Prickly: don't let up on Burzinski, Orac)

I'm with Edith. I'd take daily, hourly Burzynski posts until the truth is out and he's shut down.

I'm not one to believe in simplistic beliefs like claiming that certain people are inherently evil, but with Stan the Cancer Con Man, it's almost too easy.

I could weep, honestly.

@ Ism, the ultimate irony here (well two actually) is that the FDA has actively enabled Burzynski by allowing him to continue to "conduct" phase II and III trials without publishing results. I urge you to get your hands on Dr. Goldacre's "Bad Pharma" when it becomes available in the U.S. as it is a stunning litany of pharma and regulatory offences that keep this circle jerk going.

The other oddity is how Burzynski can be let off on this technicality when he is the ringmaster of his scam circus. Physicians in his employ are doing his bidding so I can only hope that the Texas Medical Board do go after them.

By Science Mom (not verified) on 26 Nov 2012 #permalink

@lsm

As Orac noted in his post, FDA has come down on his IRB (several years ago...would be nice to hear a followup from the FDA on that one) and just last month (concerning his promotion of antineoplastons). It would be nice to have them do something about the clinical trials themselves, given how long they've been going with zero published results and no wrap-up date in sight. Honestly, not certain what the hold up is, there.

OT note from the antivax front: there's a truly excellent op-ed piece in the Newark Star-Ledger today (along with the typical run of sane and demented comments from the peanut gallery):

ht_p://blog.nj.com/njv_guest_blog/2012/11/pro-vaccine_parents_need_to_sp.html#incart_river_default

The op-editorialist (co-author of a new book on vaccination) could use some additional favorable reviews on Amazon.

ht_p://www.amazon.com/dp/144221578X

By Dangerous Bacon (not verified) on 26 Nov 2012 #permalink

Why does this writer continue to embarrass himself? He/she has never even there during this legal process. Go back to your vaccine drivel. Good luck with your "hourly posts" in avoiding scientific fact. FDA sanctioned clinical trials, duh. Burzynski has never once lost a legal case, because, uh, he is always found to be right. Flat Earth Society is calling you all. Ring ring.

Technicality = scientific fact. Round earth = technicality.

There is some good "news" on the Burzynski clinical trials. In January of 2011, he had five open trials and the Phase III trial was supposed to open sometime that year. In January of 2012, he only had 1 open trial, and the Phase III trial is still not open for recruitment. In fact, that may explain why Deb wasn't able to enroll her child in his clinic - of the trials that may still be open (no updates since June 2009, primary end-date December 2011), none are open to both adults and children. We know that he recently treated an adult. So it appears that he may not be able to treat children unless he can manage to open the Phase III trial, which is restricted to children under 18.

Perhaps the FDA has finally told him "Tits or GTFO"?

By W. Kevin Vicklund (not verified) on 26 Nov 2012 #permalink

The Star-Ledger could use a bit of cursory fact-checking:

McCarthy has even been given her own column in the Chicago Tribune.

Wrong newspaper, and a misleading payload anyway.

Burzynski has never once lost a legal case, because, uh, he is always found to be right.

Roger, did you even read the post you're commenting on? If so, could you explain precisely how in this case Burzynski was 'right' and his accusers were 'wrong?'

Roger:

FDA sanctioned clinical trials, duh.

Then explain why the Phase III trial has not recruited any participants.

@Denice Walter:
Actually, judging from web results, the most visible propaganda outlets are dedicated sites and social media pages that appear to be either the direct work of Burzynski's staff or those who openly identify as his patients and/or supporters.

The wider "alt med" scene is no doubt a source of support for Burzynski, but I think there is a strong potential for the movement to turn against him. The problem for Dr. B on that front is that, while "alties" are infamously unfazed by questions about efficacy and even safety, they tend to be sensitive about overt commercialism and paranoid about any hint of "Big Pharma" influence. In those terms, it is to be expected that many of them are already getting uncomfortable with the clinic's publicity machine and the sheer size of the cash flow. If, on top of that, it came out that Burzynski was relying on "Big Pharma" products and even funding, then there could be an open backlash.

David N. Brown
Mesa, Arizona
www.exotroopers.wordpress.com

By David N. Brown (not verified) on 26 Nov 2012 #permalink

Roger,

You get the "facts" arse about face in almost every conceivable way - no surprise for someone who can defend Burzynski and not piss themselves laughing whilst doing so.

Stan "the brave maverick" Burzynski avoided the legal case by dis-associating himself from the wrong doing, not by vindicating the actions taken in his name in his own clinic.

The man is not only a weasel and a fraud, but lacks any conviction whatsoever.

I read many of the files at SOAH last summer. I think in one of the recent rulings the board agreed to take some of them out of public view. My impression was that would protect the ability of the doctors working under Burzynski to defend themselves if there's further action? (I'm not a lawyer.)

The last I remember, Burzynski said in his documents, yes, he saw some of the MRIs and advised the physicians, but that didn't make him responsible. At about the same time, a person offering to refer terminal cancer patients on an online support forum to Burzynski promised that he treated every patient personally. And s/he claimed to have no knowledge about any lawsuits.

What has happened to the Lola Quinlan lawsuit against Burzynski? I looked for information the other day and saw that Ms. Quinlan died last May. Will her heirs pursue the case?

@Roger - If Burzynski is right, then OJ is innocent.

I think in one of the recent rulings the board agreed to take some of them out of public view. My impression was that would protect the ability of the doctors working under Burzynski to defend themselves if there’s further action?

I don't think it would. As I recall this fairly late tidbit, the issue was that the TMB wanted to be able to use material from the informal settlement talks, which Burzynski opposed, but Burzynski included some of the information in a response, and it was later decided that the material could be submitted under seal if things went forward, and the clerk was supposed to pull the original and replace it with a redacted version. (I believe I got this backward once before, so caveat lector; the response in question hadn't been marked as redacted the last time as looked at it, so I'm not sure if that step was left off or if the response didn't get replaced as it was intended to.)

Anyway, it doesn't really impinge on the ability of the TMB to move forward in separate complaints, but that seems politically unlikely just on the basis of having blown this one.

David, I only wish the alties were sensitive about commercialization. I see them posting "information" on cancer blogs from Mercola and Robert Moss as if it were gospel.

edit-meant to say information on cancer support boards.

@bootleg,
Naturally, "alt med" communities are far more sensitive about commercialism from outside influences than among themselves. It's my observation that even commercially-sponsored alt-med sites (I consider AoA an example) will try to offer some kind of social and spiritual message and even downplay the commercial aspect.

Another thing I am beginning to wonder about: The reports of "cocktails" used by Burzinski sounds to me like a product of the "compounding pharmacy" interest. I looked under that rock some time ago when I did several research pieces on Lee Silsby, the sponsor of AoA. (See "Cures" page at evilpossum.weebly.com.) At that point, I speculated that it was not inconceivable that an operation like Lee Silsby might actually receive some discrete funding or other encouragement from a "Big Pharma" sponsor, as a way to investigate new uses of Big Pharm products quietly. If Burzynski and/or associates have gotten themselves into the compounding business, I believe it's very possible they found some "mainstream" pharmaceutical backing.

David N. Brown
Mesa, Arizona

By David N. Brown (not verified) on 26 Nov 2012 #permalink

Lola Quinlan did die, May 2012. I located this, which indicates that Ms. Quinlan (or her estate), did prevail with the lawsuit against Burzynski and his pharmacy, when Burzynski overcharged Quinlan for chemotherapeutic drugs.

Did Burzynski then start to appeal that verdict...then make a motion to dismiss his own appeal...which was granted?

http://statecasefiles.justia.com/documents/texas/first-court-of-appeals…

Your posts are too biased. I neither defend nor support Dr. Burzinski, but it is more than obvious that you are already too opinionated to write objectively (I actually doubt this has ever been a premise for you).

Had the ruling been different, how would you have written this phrase below?

"Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski’s work, nor does it in any way vindicate him. He got off on a technicality, and that’s all."

"Just because ..." bla, bla, bla ... you were a surgeon, not a judge, correct? Neither a lawyer (apparently). Finding excuses and turning everything in your favor for the sake of your argumentation is not very noble.

But we already knew surgeons are pretty biased ...

By the way, don't hold out much hope for the TMB of doing anything. PublicCitizen had a full article in the "Outrage of the Month" section in their Oct. Health Letter on the "Deficiencies of the Texas Medical Board."
Essentially, "the report provides evidence concerning the inadequate capacity of the Texas Medical Board to protect Texas patients form preventable medical harm."

@Jim

How would any ruling on a point of administrative law said anything about whether or not Burzynski's practices actually work as claimed?

(By the way, perhaps you missed the bit where Orac admitted that he is not a lawyer and that he got help from an actual lawyer on the points of law in this article.)

Roger: "Burzynski has never once lost a legal case, because, uh, he is always found to be right."

Rog, could you pass along this wisdom to the folks at Wikipedia?

"Burzynski’s use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. Food and Drug Administration (FDA) and the Texas Attorney General,] and limits on the sale and advertising of the treatment were imposed as a result...
In 1994, Burzynski was found guilty of insurance fraud for filing a claim for reimbursement by a health insurer for an illegally administered cancer treatment."

By Dangerous Bacon (not verified) on 27 Nov 2012 #permalink

I don’t follow the legal argument that Dr. B is not responsible because he doesn’t treat the patients. If I hire someone to kill my spouse, I am guilty of murder as I understand it. How is this different? I admit my ignorance of the law, so perhaps someone can enlighten me a bit.

Jim

Ahhhhh.......relativism. The poltically correct notion that all ideas, however nonsensical, no matter how discredited, should be given equal weight when being considered.

You are just plain WRONG. Asking how Orac would have responded were the facts different is pointless. Search out and watch Terence Mckenna's discourse on relativism on youtube to see why you are wrong, he explains why your point of view is ridiculous far more succinctly and amusingly than i am able to do.

Burzynski himself put his ideas outside the realm of what should be given serious consideration when he refused to back up his grandiose claims with actual evidence and began his 30+ year campaign of fraud against the desperate and confused.

@JBC

Difference between administrative law and tort law. TMB has authority to impose sanctions on a physician's practice of medicine based on how they've practiced medicine on patients. So, if he had actually seen patients directly or otherwise been directly involved in the management of their care, they could do something to him. But, because he was not directly involved in the care of the patients, TMB can't impose sanctions against his license to practice.

The TMB can't sue on a tort action because they were not wronged by Burzynski. Only the patients and/or their families could bring such an action against him. In a tort action, it doesn't really matter whether he was directly involved or not; as the employer/director of the clinic, he bears at least some measure of responsibility.

At least, that's my understanding, but IANAL.

Jim:

Your posts are too biased. I neither defend nor support Dr. Burzinski, but it is more than obvious that you are already too opinionated to write objectively (I actually doubt this has ever been a premise for you).

[sarcasm ]Yeah! Isn't it terrible that Orac is so biased against taking tens of thousands of dollars from families who are just trying to cure their loved ones. Oh, and he just keeps asking, asking and asking for the papers for those clinical trials. Jeesh, those people were going to die anyway, so why not let Burzynski continue to let them pay for him to do his experiments. He will tell us the results when he is and ready to, he doesn't need Orac, the FDA, and others to tell him how run his clinics. Right? [/sarcasm]

And when they've successfully shut this guy down, go after the likes of Benny Hinn. He does the same thing except without the medicinals. He claims to be able to cure, yet there are all manner of examples of his "clients" that are not cured. And he and his enterprise pay very little tax.

@ DFR: Orac has already blogged about Benny Hinn...and other faith healers:

http://scienceblogs.com/insolence/2011/02/10/benny-hinn-dark-lord-of-th…

And...

http://scienceblogs.com/insolence/2010/11/19/for-shame-oprah-winfrey-sh…

IANAL. I agree with Todd W's post about the difference between an administrative hearing conducted by the Texas Medical Board and civil tort lawsuits instituted by Burzynski's patients, or the survivors of those patients.

Orac and other science bloggers have posted about Burzynski's "treatment" and the indiscriminate use of traditional chemotherapeutic medications. These blogs have had an impact on potential patients and their families. Perhaps some of Burzynski's victims and or/their families will institute lawsuits against Burzynski and his staff. Enough negligence lawsuits against them, would result in them being uninsurable against medical malpractice.

@DFR,
That would be an arguable restraint of religious exercise. I studied the subject of "faith healing" as a seminary student, and my evaluation of Hinn was that he at least distanced himself from egregious abusers like Peter Popoff. From a legal perspective, advocates of "faith healing" are on a solid footing as long as they present themselves primarily as religiously-based emotional support, and especially don't advise anyone against seeking orthodox medical treatment. An additional legal consideration is that "non-profit" religious organizations would mainly fall under the jurisdiction of the IRS.

David N. Brown
Mesa, Arizona

By David N. Brown (not verified) on 27 Nov 2012 #permalink

@Todd W.

I did not miss anything. I spend days to cover all Orac has written about that case.

"Burzynski’s practices and work" is too broad in scope to comment on it in a definitive manner.

@MarkL

You have no idea what you are talking about, and you obviously had not idea what I was talking about. Hence, dismissed.

@Chris

Yes, and perhaps you think this is very different from what you are basing your sarcasm on:

http://www.washingtonpost.com/business/economy/as-drug-industrys-influe…

Oh, I forgot - these were real companies, real researchers doing real science. It is just 4 years = 80,000 people becoming victims - nothing to compare with 30+ years and hundreds dying from something that they would ... have died from anyway.

If Burzynski is wrong (and probably he is), so is almost everybody else in this "business". Oh, did we forget that Orac is perhaps in the same or similar business? Shifting the focus is a very convenient strategy. Finding a scapegoat while doing that is even better. Throwing accusations without presenting known facts of similar cases from the "real science field" is definitely subjective. All of this combined = biased representation. A fact, regardless of whether or not you like it. I understand your feelings and ego may be hurt, but try to detached yourself from them to see the world from a logical, objective point of view.

@All

As a matter of fact, I support more than 50% of what Orac has written about the case. But not acknowledging the obvious is simply a prejudiced behavior derived from specific personal experiences and motives.

Life is subjective, as is science. Don't try to represent science as the only true solution to all problems - it is not. You know nothing about how exactly the human body functions at molecular level, as does Dr. Burzynski. Therefore, please don't make huge conclusions based on superficial knowledge.

You could try to be more objective, because you can. You simply don't want to. It's called ego and defense of the own territory.

This news is both sick and sad. Is there any way to appeal?

Jim,

You're wrong to write “You know nothing about how exactly the human body functions at molecular level” as some out-of-hand straw-man dismissal.

Orac is a researcher as well as a surgeon - he has a decent enough knowledge of the molecular biology of cancer.

Likewise, some of us ‘@All' commenting do in fact know molecular biology.

Regards your idea that Science is subjective: individual people might have their interpretations of data (like your own for that matter) but the data itself are the data - you can't wave them away.

Jim,

I am dismissed? You are too funny. What exactly is your point?

Burzynski is a fraud, and we can safely continue to describe him as such because a) he has already been labelled a fraud by the FDA and by the courts for fraudulent health insurance claims and b) he has NO evidence to support either the efficacy of his treatments or a contrary opinion of his character. Yes, the scientific argument is biased, but that is because all available evidence is against Burzynski, and he refuses to join the debate, refuses to provide the data that vindicates his "wonder cure". What do we get instead? , obfuscation, evasion and now comical attempts to portray his escape from legal censure (by abandoning his subordinates and leaving them to take the blame) as a vindication of his medical expertise .

Despite opening 60 phase 2 trials over decades, he has not added one scintilla of knowledge to the cumulative fight against cancer. That in itself tells a pretty straightforward story. He has enriched himself by selling false hope to desperate families around the world.

I don't need to know the details of how the human body functions at a cellular level to know a snake oil salesman when I see one. And if Burzynski and his supporters want to overturn that widely held opinion of him, then they know what to do - release the accumulated data from his incomplete trials and show the scientific community and the world at large that he ISNT just another money grubbing weasel.

FWIW, I emailed the following to suggestions@ProPublica.org:

There is a doctor in Houston, Texas, who runs an eponymous "cancer clinic". He purports to have an "all natural" cancer cure called "antineoplastons", that is not chemotherapy, and will cure when conventional treatment has failed, even on the most rare and difficult types of cancers.

In fact, he sells chemotherapy - conventional chemotherapy drugs - marked up far beyond the prices patients would pay at regular hospitals. He treats on a cash only basis, and has attracted desperate patients from the US, Canada, Europe, and Australia.

Many of these are parents who have young children that have been treated by experts. Rather than enjoying their last days together as a family, they spend time in run-down motels, having scraped together the needed cash through friends, family, charity appeals, and others.

Google searches will yield names of some of Burczynski's victims, as well as a couple of former patients that were mad as hell when they found out they were being swindled.

Burczynski has, in the past, threatened people. See the Respectful Insolence blog (written by breast cancer surgeon and researcher Dr David Gorski) and the Quackometer blog (written by Andy Lewis) for further details.

I believe this would be a good story for ProPublica to research and write. Exposing Burcynski would help to make a case to have his doctor's licence revoked by the Texas Medical Board, one of the laxest medical licensing bodies in the country.

There is more, but I am sure - should ProPublica decide to look into this story - you will find out how horrible it is, and how many lives he has touched for the worse.

You know nothing about how exactly the human body functions at molecular level, as does Dr. Burzynski.

Given the miscellaneous oddities of tense construction in your broadcast, I would like to ask whether this is supposed to mean what it plainly reads as.

Jim, how does other pharmaceutical companies doing bad things exonerates Burzynski charging tens of thousands of dollars to desperate cancer patients okay dokay? Or makes it okay to claim he is doing clinical trials when he has never published any results?

At least the those drug companies do publish results, and are required to have the unpublished data available.

By the way, Burzynski also owns real companies: his clinic and the pharmacy where he charges exorbitant prices.

Should I waste my time and energy on Stanislaw R. Burzynski like people here? Or on:
2007 $515 Million: Bristol-Myers Squibb
2007 $634 Million: Purdue Pharma
1/2009 $1.415 Billion Fine: Eli Lilly and Company
2009 $2.3 Billion Fine: Pfizer
2010 $520 Million: AstraZeneca
2011 $950 Million: Merck
6/4/11 $327 Million Fine: Janssen Pharmaceutica
10/2011 $780 Million Fine: Amgen
4/11/12 $1.2 Billion Fine: Johnson & Johnson and subsidiary
5/10/12 $1.5 Billion Fine: Abbott Laboratories
7/2/12 $3 Billion Fine: GlaxoSmithKline
7/16/12 $13 Billion Fines: Big Pharma in 4 years
9/21/12 $11 Billion Fines: Pharmaceutical companies in last 3 years (8 out of top 10)
10/21/12 $1 Million Fine: Ft. Mill Pharmaceutical Company
10/26/12 $95 Million Fine: Boehringer Ingelheim
$760 Million (Pending): Amgen
$1.5 to $2 Billion Fine (Pending) Johnson & Johnson

By Didymus Judas Thomas (not verified) on 27 Nov 2012 #permalink

There's no reason we can't do both; i.e., go after unethical "researchers" like Burzynski and keep an eye on pharmaceutical companies. Actually, Burzynski behaves more unethically than a pharmaceutical company in that he does things that pharmaceutical companies don't do, such as charging patients huge sums of money to be in his "clinical trials."

DJT - Big Pharma had me in a clinical trial for free. In fact, I was given money for parking and lunch.

Too bad the name of your hero ain't on your list. An ol' timey gibbeting would be more apropos but I'll settle for stripping him of his acreage with custom wrought-iron gates.

By al kimeea (not verified) on 28 Nov 2012 #permalink

Quickly again, cause work needs to be done. :)

@Grant

Please read carefully my sentence again. I'm not wrong, because I know what I'm talking about. Had you known "how exactly the human body functions at molecular level", a cure for cancer would have been found.

Molecular biology touches only the surface. I'm talking about different spatial and temporal scales - access to which will provide a complete picture of the molecular processes within the human body. Yes, you do have some knowledge, but it just remains "decent". Similar to the $200 billions over the last 35 years the US have invested in the "fight against cancer". Scientific result = some "decent" progress. Real result = zero.

As for the subjectivity, how many times do you carefully and methodologically look at raw data coming from work done by other people, researchers, institutions? And how often do you just read the abstracts, introductions and conclusions of their reports? Give me these two numbers per number of reports per year and then we can talk about data and interpretation. Moreover, big (raw) data introduces even bigger biases.

@MarkL

You are funny too. Why do you think that I care about Burzynski? No need to convince me of anything - he is not the first, won't be the last one to generate such a controversy. My point was that if he was a bad person of 100 on some random scale, there were many other people who would fell within the range 90-100, but apparently they served special interests and hence, better not talk about them. Objective and fair?

@Narad

No, it was not supposed to mean that. He also falls within the "not-knowing" category.
Grammar in comment sections in blogs is not my priority. When writing quickly, I often omit or misplace certain words/letters. Moreover, literature and language are not my strengths, so don't claim proficiency.

@Chris

Let's not go into the money thing, because healthcare takes 17.8% of the GDP of the country, so please. Healthcare costs faced by a cancer patient elsewhere are on the same order of magnitude as what Burzynski charges patients. When exactly the money is taken, before, during or after a clinical trial, is irrelevant from a patient's point of view. It's simply a "technicality".

Drug companies have been required to provide their data to the public for about a couple of years now. Burzynski is not that different - sooner or later he will show you the data, what's the problem? I don't really see a big difference between his way of hiding data from the way drug companies and some researchers had hiden data for many years in the past.

@Orac

I disagree on two points:
1. You should go after all that do unethical things. Not "go after" Burzynski and just "keep an eye" on pharmaceutical. Bias?
2. How much does a human life cost? Let's then talk about who behaves "more unethically".

@DJT

This is actually a small list.
I know most of you would say that "all these companies did ethical things, but were unfortunately fined on technicality"...
Cheers!

Please read carefully my sentence again. I’m not wrong, because I know what I’m talking about. Had you known “how exactly the human body functions at molecular level”, a cure for cancer would have been found.

Molecular biology touches only the surface. I’m talking about different spatial and temporal scales – access to which will provide a complete picture of the molecular processes within the human body.

What a load of bollocks; you sound like a whiny homeopath who claims that "materialistic science" cannot measure homeopathic effects. The fact is Jim that much is known "at the molecular level" how cancers form. The problem is Jim is that cancers have multiple aetiologies and finding ways to kill the cancer without killing the patient are exceedingly difficult. You would know this if your understanding of molecular biology transcended everyone else's as you imply.

I disagree on two points:
1. You should go after all that do unethical things. Not “go after” Burzynski and just “keep an eye” on pharmaceutical. Bias?
2. How much does a human life cost? Let’s then talk about who behaves “more unethically”.

A boring Tu Quoque argument. I have no love for pharmaceutical companies and their antics but the fact that they are held to a modicum of regulatory standards and fined for violations stands in stark contrast to the slimy dealings of Burzynski who has been left relatively unfettered to bilk individuals out of money and precious time.

I know most of you would say that “all these companies did ethical things, but were unfortunately fined on technicality”…

And you know this how? Because you have chosen to paint yourself into a corner with your rigid thinking? Pharma behaves badly and should be punished is not mutally exclusive of Burzynski behaves badly and should be punished. In fact it's more consistent than the hand-waving rubbish you've produced.

By Science Mom (not verified) on 28 Nov 2012 #permalink

Jim, project much oh great and mighty OZ?

By al kimeea (not verified) on 28 Nov 2012 #permalink

Jim.

Ohhh, so we are being too nasty to Slimeball Stan and not nasty enough to other peddlers of woo? You obviously don't read much of Orac's output, they all come in for a bashing.

Oh wait - no, you appear to have changed tack again....... we are too mean to peddlers of woo and not mean enough to Big Pharma.

"Molecular biology touches only the surface. I’m talking about different spatial and temporal scales........"

Oh wait, no, you are talking bollocks.

Let's say I claimed to have a dietary cure for advanced cancers--lots of fresh green veggies, for example, and for several decades I'd been charging patients 10's of thousands of dollars to participate in clinical trials of my diet but refused to make public the results of these trials. Further, I insist that my patients purchase their veggies at a specific grocery store where a head of lettuce goes for $2800 and tomatoes cost $395 each (and which--what a coincidence--I own.)

Now top that off with the fact that not only do I offer no evidence my diet works, but the diet has previously looked at by multiple independent researchers and found not to be an effective cancer treatment (just as phenyl butyrate--the pro-drug for the metabolites Burzynski calls antineoplastins--had been evaluated extensively without evidence of practical efficacy.)

Would you still be saying "No biggie--sooner or later he'll show us the data so -where's the problem?

@Jim

@Todd W.

I did not miss anything. I spend days to cover all Orac has written about that case.

“Burzynski’s practices and work” is too broad in scope to comment on it in a definitive manner.

Hey, way to focus on an aside, rather than on the actual question I asked, Jim! Wow. You sure brushed that inconvenient question out of the way. I admire your integrity and rhetorical skill. Tell me where I, too, can become as proficient as your own mighty self?

Now, then, Jim, how would any ruling on a point of administrative law said anything about whether or not Burzynski’s practices actually work as claimed?

Perhaps this time you'll answer.

Okey-dokey. Exhibit 1:

Please read carefully my sentence again. I’m not wrong, because I know what I’m talking about.

Exhibit 2:

[Burzynski] also falls within the “not-knowing” category.

So, let's play a game. Call it "Bunny Feedies." Why was the cellular dynamics of non-purse-string wound healing well reckoned by washing out precisely the details of "molecular processes" that you're nattering on about?

Orac: Do I understand correctly that you are really seriously attempting to contend that Big Pharma was Fined $13 BILLION (That is BILLION with a "B") over this 4 year period and GlaxoSmithKline was Fined $3 BILLION this year (the largest ever Fine on a drug co) for behaving MORE ETHICALLY than SRB?
Please provide "FACTS" that support your false allegation that SRB "behaves more unethically" than Big Pharma in that he does things that Big Pharma doesn't do.

al kimeea: Please see below regarding Big Pharma; whom I refrain from calling your "hero" as I have no "FACTS" to substantiate such a claim in the course of this lively civil discourse.
Please provide "FACTS" that support your false allegation that SRB is my "hero."
Please provide "FACTS" on how much SRB has been Fined so that he may be added to my list.

I will happily accept your apologies.

Bristol-Myers Squibb
1. Gaming the system to jack up prices on a drug,
2. The FDA had approved a drug for adults, but not for children & adolescents, and not for geriatric patients suffering dementia. In fact, the agency explicitly warned against using it for dementia. BMS zeroed in on child psychiatrists & other pediatric specialists & created a team to exclusively call on nursing homes.

Purdue Pharma
1. Fraudulently misbranding drug for suggesting it was less addictive & less abused than other drugs,
2. Sales representatives saying users could stop using the drug, without withdrawal. Sales representatives were allowed to draw "fake scientific charts," on the drug's safety, which they passed out to physicians as proof of their claims.

Eli Lilly and Company
1. Allegations that they pushed drug for children & for elderly dementia patients, both off-label uses. Made particular efforts to push a drug in long-term care facilities & nursing homes. Aimed to make a drug a primary care drug, despite the fact that it was only approved to treat 2 disorders--typically not handled by primary-care doctors,
2. Misdemeanor misbranding charge for promoting drug off-label,
3. Civil wrap-up for the feds & to states that agreed to settle.

Pfizer
1. Improperly marketing drugs (It is illegal to promote uses for a drug that have not been approved by the FDA — a practice known as off-label marketing),
2. Encouraging doctors to prescribe its drugs with free golf, massages, & junkets to posh resorts,
3. At the very same time Pfizer was negotiating & resolving the allegations of criminal conduct by its then newly acquired subsidiary, Pfizer was itself in its other operations violating those very same laws,
4. Variety of marketing infractions. Sales reps were rewarded with junkets & cash for pushing a drug as a multi-purpose pain reliever when it was only approved for arthritis pain. Sales employees explained that off-label promotion was tolerated & no big deal, even though they knew it was illegal.

AstraZeneca
1. Pursued a host of ploys to get doctors to write off-label prescriptions for its drug, like paying them fees for articles & studies ghostwritten by others.
2. Drug had been approved for treatment of a number of uses, but investigators found that AZ was trying to get physicians to write prescriptions for a long list of uses for which the drug was not approved. Targeted doctors who did not typically treat the conditions the drug was approved for, such as physicians who treat the elderly, primary care physicians, pediatric & adolescent physicians.

Merck
1. Marketing allegations (hawked drug for an unapproved use),
2. Allegations that they exaggerated the drug's safety & downplayed its risks. They pulled the drug for safety reasons after data linked it to increased risks of heart attack & stroke,
3. Reps misled doctors about the drugs safety to boost sales & that the company lied to state Medicaid programs about the drug's risks,
4. [Misbranding] violation. Criminal fine-for a misdemeanor misbranding violation-payment to wrap up civil claims, including those filed by 40 states attorneys general.

Amgen
Allegations of kickbacks & other marketing infractions designed to boost sales of drugs.

Johnson & Johnson and subsidiary
1. Off-Label promotion (marketing practices involving 2 drugs, misbranding a drug),
2. State claims of Medicaid fraud,
3. Kickback allegations involving a nursing home pharmacy provider & several other drugs,
4. Texas settled its off-label marketing claims against J&J,
5. Arkansas, where a jury found the company guilty of fraudulently marketing a drug-and a judge ordered the company to pay a $1.2 billion penalty. (That award is under appeal.)

Abbott Laboratories
1. Marketing/Misbranding charge (promoted a product-a seizure drug-for off-label use in elderly dementia patients who became agitated or aggressive. A specialized, specially trained sales force pushed drug in nursing homes to help control these patients, even though it had no credible evidence that the drug was safe or effective for that use. Had to stop a clinical trial in elderly dementia patients because of adverse events. Pushed drug as a schizophrenia treatment. Though the drug was approved to treat mania in bipolar patients-and sometimes those patients display psychotic symptoms-clinical trials showed the drug added to antipsychotics didn't help schizophrenia patients any more than the antipsychotics alone. The company didn't tell sales reps about that data for 2 years),
2. Allegations that its marketing tactics triggered false claims to government health programs, including Medicare & Medicaid
3. Paid to wrap up consumer-protection claims at the state level.

GlaxoSmithKline
1. Illegal promotion of some of its products for unapproved uses not cleared by the FDA (promoting [marketing] off-label, non-covered uses),
2. Employed several tactics aimed at promoting the use of a drug, including helping to publish a medical journal article that misreported data from a clinical trial,
3. Failure to report safety data to the FDA (failed to report to the FDA on safety data from certain post-marketing studies & from 2 studies of the safety of a drug - drug linked to heart risks, failed to report data from studies detailing the safety risks to the FDA, allegations that it downplayed the safety risks of a drug, withheld data from the FDA until studies raised red flags about risks to the heart, false-claims allegations-exaggerating a drug's benefits),
4. Alleged false price reporting (pricing & rebate claims),
5. Introducing misbranded drugs (2 misbranding charges),
6. Improper marketing of drugs (allegations of mismarketing 5 drugs),
7. Tried to win over doctors by paying for trips to Jamaica & Bermuda, as well as spa treatments & hunting excursions,
8. Alledgedly paid kickbacks to doctors to prescribe drugs,
9. Allegedly overcharged the government for drugs.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the major pharma lobbying group, claims its members are “committed to following the highest ethical standards and all legal requirements,” according to PhRMA’s website. To demonstrate this, PhRMA members developed the “Code on Interactions with Healthcare Professionals,” which states that: Ethical relationships with healthcare professionals are critical to our mission of helping Patients . . . An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines.” Nearly 60 pharma companies; including Abbott, Pfizer, Eli Lilly, Glaxo, J&J and Amgen, are signatories to the code. At least 3 of them: Abbott, Pfizer & Eli Lilly - while the PhRMA code was in place they committed these billion-dollar-plus violations.

By Didymus Judas Thomas (not verified) on 28 Nov 2012 #permalink

So, your argument is, Didymus Judas Thomas, that because of Big Pharma was naughty that it is okay dokay for Burzynski to charge tens of thousands of dollars to be part of his "clinical trials", that he has conducted for thirty years but has not published are real results.

It seems things are getting interesting here. :) So interesting that some egocentric people, a.k.a. the God of Science, found a way to disseminate their anger via usage of offensive language. @Mom, I'm sorry for being a "rigid", "rubbish" "homeopath" and do not live up to your standards of holy knowledge. My deep apologies, it won't happen again.

Next.

@al kimeea

Mutual.

@MarkL

You are killing me. You must be a comedian, right?
Do you think I expect comedians to really understand science?

@JGC

Some of your statements are not factual. Regardless, if you hold a single person so much accountable when evidences for a myriad of similar or even worse practices exist , my answer to your question would be Yes. It will be Yes until you realize how hypocritically you act by showing double standards.

@Todd W.

Ignoring the irony, I gave an answer to your question to the extent I was able to answer. If you want an answer, I'd say "I don't know how." However, as far as a remember, the results of this ruling have triggered this post we are commenting on right now. And as far as I remember, many people, including the writer, inferred many things about the Burzynski’s practices regardless of the nature of the ruling. So, why not wait for a non-administrative ruling and then make your huge accusations?

But no, many of you cannot wait for this. They are the Gods and only a few (actually one unlucky) are highly "privileged" to experience their judgmental force. Others with similar sins are intentionally excluded. It looks like a modern version of ritual human sacrifice to Gods.

@Narad

I don't play games. Moreover, your games are becoming boring.

@All

I came here to say a single thing:

"The writer shows a huge bias in this post probably derived from his opinionated nature, personal experiences and biological & social instinct for survival pushing towards finding a culprit and exposing him (as a scapegoat), which makes the writings unattractive and highly subjective. 25% more objectivity by showing other sides of the same problem would make a pleasant difference. Otherwise, it looks like the author has something personal against some individual, named Dr. Burzynski in this particular case."

Whatever else topic you implied or tried to propagate to me remained somewhat irrelevant and I did not really feel you talked to me.

The logic is nonexistent anymore, so:

Have a good day. Positivism can help with anger and other personal physiological issues.

PS. @DJT, thanks for trying to balance the discussion by shedding some light onto the same, but real and much bigger problem than the one being described here.

Please provide “FACTS” that support your false allegation that SRB “behaves more unethically” than Big Pharma in that he does things that Big Pharma doesn’t do.

Are you going to get to the question that was posed to you?

Oh, dear, "Jim" isn't CITIZEN JIMSERAC, is it?

“The writer shows a huge bias in this post probably derived from his opinionated nature, personal experiences and biological & social instinct for survival pushing towards finding a culprit and exposing him (as a scapegoat), which makes the writings unattractive and highly subjective. 25% more objectivity by showing other sides of the same problem would make a pleasant difference. Otherwise, it looks like the author has something personal against some individual, named Dr. Burzynski in this particular case.”

Yup. Classic crap artist techniques. "In actuality, all I know about Orac is that my fee-fees get hurt when he says mean things about my pwecious Stanley. But if I talk about his 'opinionated nature,' 'personal experiences,' 'biological & social instinct for survival pushing towards finding a culprit,' I might fool some rubes into thinking I'm doing anything more than airing out my pie-hole."

Fact: Burzynski has been claiming for thirty years that he has vital knowledge about how to treat cancer.

Fact: Burzynski has had thirty years to actually demonstrate the truth of that claim by doing the studies. He hasn't.

Fact: Burzynski has instead over those thirty years enriched himself by misleading desperate patients into buying standard chemotherapy drugs at highly inflated, nonstandard prices.

Fact: Nothing that anyone else on Earth does - not Big Pharma, not Pol Pot nor Idi Amin nor Jeffrey Dahmer nor Charlie Manson - make any of the above less wrong for Burzynski to do.

How come you don't care about cannibalism and murder, Diddums? Surely you can't criticize Big Pharma unless you first criticize everyone who's actually gone out and committed violent murder with their own hands, especially those who then go on to eat their victims! If not, aren't you essentially giving a free pass to murderous cannibals by focusing on Big Pharma instead?

See, that's the kind of absurd logic you get by refusing to realize that "tu quoque" is a fallacy. The fact is that Burzynski acts unethically and nothing obligates us to delay talking about his unethical acts until we've gone through all the conversational detours you'd love us to go through.

By Antaeus Feldspar (not verified) on 28 Nov 2012 #permalink

Oh, dear, “Jim” isn’t CITIZEN JIMSERAC, is it?

Could be:

I submit that Homeopathy, if proven,
provides the missing link, the alternative
viewpoint which is superior to the
totally reductionistic approach in handling
problems of the above mentioned kind.

Same pompous, vapid, bluster.

By Science Mom (not verified) on 28 Nov 2012 #permalink

Chris, it is somewhat ironic that your Location is "Neither here nor there..." since "Neither here nor there" did I indicate that my argument was "that because of Big Pharma was naughty that it is okay dokay for Burzynski to charge tens of thousands of dollars to be part of his “clinical trials”, that he has conducted for thirty years but has not published are real results."

I will be happy to accept your apology.

Chris, if I understand you correctly, you want me to do your research for you. Thank you for the opportunity to do your research for you.

Below are resources for your reading enjoyment.
You can access the link below re SRB and view the clinical trials. Please feel free to read the available information about exceptions to results being required to be submitted. Perhaps SRB's work comes under an exception. You may contact them on their site by phone & live chat with any questions you might have.

http://clinicaltrials.gov/ct2/resultsterm=Burzynski&Search=Search

Per-patient clinical trial costs have risen an average 70% across all development phases since 2008. Phase I per-patient costs increased an average 46%. Phase II costs increased an average 72%. The largest increases in per-patient costs came in Phase IIIa & Phase IIIb, which saw an average 88% & 86% rise, respectively.
The most significant factor for increased clinical trial costs is patient recruitment. This comes as no surprise because clinical development teams have struggled to enroll sufficient volunteers to fill trials for several years now.
Dramatic rise in cost to research & develop drugs that are eventually brought to market: In 1975, bringing a drug to market cost $100 million in 2012-adjusted dollars. By 2005, that figure had exploded to more than $1.3 billion, according to numbers from the Tufts Center for the Study of Drug Development.
The top 20 drug companies spend $30 billion on research & development, about 40% of which goes to fund clinical trials.
8 of the top 15 drug companies did not get the go-ahead for a single drug last year.
In 1980, drug companies spent some $2 billion on R&D, and 34 new drugs were approved. In 2000, they spent close to $30 billion, but only 24 drugs were approved.
Completing all the phases of clinical trials required for approval of a new drug can cost anywhere from $300 to $800 million.
Although the NIH budget has doubled in the past five years-with the implied purpose of encouraging the development of new drugs-the FDA's budget remains inadequate to review these drugs for qualification.

www.pdpipeline.org/2011/clinicaltrials/recruitretention.htm

www.cuttingedgeinfo.com/2011/per-patient-clinical-trial-costs

www.pharmalot.com/2011/07/clinical-trial-costs-for-each-patient-rose-ra…

www.raps.org/focus-online/news/news-article-view/article/1359/report-ph…

www.forbes.com/sites/aroy/2012/04/25/how-the-fda-stifles-new-cures-part…

www.ciscrp.org/professional/facts_pat.html

By Didymus Judas Thomas (not verified) on 28 Nov 2012 #permalink

Jim - Hilarious, you're the compleat troll.

Narad, did you read the post I posted before your post? Here is more interesting reading:

www.huffingtonpost.com/mobileweb/dr-peter-breggin/drug-companies_b_1646…

Extreme tactics have also been used by other drug companies in regard to marketing psychiatric drugs for children. Drug companies allegedly paid 7 figures to 3 Harvard professors of psychiatry - who then went on to encourage diagnosing children with bipolar disorder & medicating them with antipsychotic drugs.

By Didymus Judas Thomas (not verified) on 28 Nov 2012 #permalink

@DJT,

I am aware of that. Please keep in mind that pharma company got no free lunch here (and I also used to read 1boringoldman's blog) but also, keep in mind if it was not for pharma company and their medication, I'd be dead today.

Alain

Diddums has just cited well known crank Peter Breggin, can Mercola, Adams and Null be far behind. Does anyone know if Breggin has been on Alex Jones' Prison Planet?

By Militant Agnostic (not verified) on 28 Nov 2012 #permalink

Breggin does have his own weekly show on PRN - I assume Denice is more familiar with him. I have read part of one of his books back in my altie days and was favorably impressed at the time. However, the more I have heard of him lately, and the more I have learned about neuroscience the more convinced I am that he is a mental illness denialist. As the evidence for a biological and often genetic in various mental illness increases, he doubles down on the denialism. I would like to hear DWs take on him.

By Militant Agnostic (not verified) on 28 Nov 2012 #permalink

1. You should go after all that do unethical things. Not “go after” Burzynski and just “keep an eye” on pharmaceutical. Bias?

Apparently there is an Internet Law that prevents Jim and any bloggers other than Orac from criticising ethical violations in the cancer-treatment field. Otherwise Jim would be able to "go after all that do unethical things" rather than demanding that Orac do it.

By herr doktor bimler (not verified) on 28 Nov 2012 #permalink

Didymus Judas Thomas, okay, do my research for me:

Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.

@AdamG

Now there's a howler that the rest of us missed. I am thinking Bo Diddly's dimmer brother must be living on a planet where underpants are worn on the head on a regular basis.

I think we are dealing with a bull$hitter in the philosophical sense i.e. someone who does not care whether what they say is true or false.

By Militant Agnostic (not verified) on 28 Nov 2012 #permalink

You can access the link below re SRB and view the clinical trials. [...].
http://clinicaltrials.gov/ct2/resultsterm=Burzynski&Search=Search

Most commenters here are familiar with the clinicaltrials.gov database. It lists 62 trials under "burzynski", most of them registered in a flurry of activity on Nov. 1 1999 which presumably corresponds to the opening of the legal loophole that Burzynski is exploiting. One of those 62 is someone else's research on tuberculosis.

*One* study has been "completed" (in 2009; no results published); two have been "terminated" (i.e. abandoned without results due to too few subjects). Seven were "withdrawn" after seven years because Burzynski had not bothered recording any subjects at all. One (registered 2010) is not yet recording subjects.

The other 51 are all "status unknown" because Burzynski has not bothered updating the records with information about subjects.

Is this intended to convince anyone of Burzynski's sincerity and commitment to testing the efficacy of his treatment?

By herr doktor bimler (not verified) on 28 Nov 2012 #permalink

Militant Agnostic: "[C]rank Peter Breggin must be a pretty good "crank" seeing as how he has been a medical expert in a number of product liability suits against drug companies & a judge made public his report as noted in the link I provided.

Chris, here are the PubMed's:
Antineoplaston A in cancer therapy. (I).
www.ncbi.nlm.nih.gov/m/pubmed/275868
Antineoplastons: history of the research (I).
www.ncbi.nlm.nih.gov/m/pubmed/3527634
Phase I clinical studies of antineoplaston A3 injections.
www.ncbi.nlm.nih.gov/m/pubmed/3569012
Phase I clinical studies of antineoplaston A5 injections.
www.ncbi.nlm.nih.gov/m/pubmed/3569014
Initial clinical study with antineoplaston A2 injections in cancer patients with five years' follow-up.
www.ncbi.nlm.nih.gov/m/pubmed/3569010
Preclinical studies on antineoplaston AS2-1 and antineoplaston AS2-5.
www.ncbi.nlm.nih.gov/m/pubmed/3743376
Toxicology studies on antineoplaston AS2-5 injections in cancer patients.
www.ncbi.nlm.nih.gov/m/pubmed/3743377
Toxicology studies on antineoplaston AS2-1 injections in cancer patients.
www.ncbi.nlm.nih.gov/m/pubmed/3743378
Toxicology studies on antineoplaston A10 injections in cancer patients.
www.ncbi.nlm.nih.gov/m/pubmed/3743380
Chronic animal toxicity studies on antineoplaston A2.
www.ncbi.nlm.nih.gov/m/pubmed/3743382
Potential of antineoplastons in diseases of old age.
www.ncbi.nlm.nih.gov/m/pubmed/8535046
Efficacy of antineoplastons A10 and AS2-1.
www.ncbi.nlm.nih.gov/m/pubmed/10377942
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
www.ncbi.nlm.nih.gov/m/pubmed/12718563
The present state of antineoplaston research (1).
www.ncbi.nlm.nih.gov/m/pubmed/15035876
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme.
www.ncbi.nlm.nih.gov/m/pubmed/15312271
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report.
www.ncbi.nlm.nih.gov/m/pubmed/15563234
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1.
www.ncbi.nlm.nih.gov/m/pubmed/15911929
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
www.ncbi.nlm.nih.gov/m/pubmed/16484713
Treatments for astrocytic tumors in children: current and emerging strategies
www.ncbi.nlm.nih.gov/m/pubmed/16774296
Stanislaw R. Burzynski, MD, PhD: novel cancer research and the fight to prove its worth.
www.ncbi.nlm.nih.gov/m/pubmed/22875562

By Didymus Judas Thomas (not verified) on 29 Nov 2012 #permalink

So Jim has departed having been exposed as a troll. Did he ever put forward a real complaint other than "I don't like Orac" ?

It is ironic in the extreme that his complaint was dressed up as "Orac holds a personal grudge against Burzynski".

from wiki here's what several other judges have had to say aboot Breggin's "expertise"

Several judges have questioned Breggin's credibility as an expert witness. For example, a Maryland judge in a medical malpractice case in 1995 said, "I believe that his bias in this case is blinding... he was mistaken in a lot of the factual basis for which he expressed his opinion."[48] In that same year a Virginia judge excluded Breggin's testimony stating, "This court finds that the evidence of Peter Breggin, as a purported expert, fails nearly all particulars under the standard set forth in Daubert and its progeny.... Simply put, the Court believes that Dr. Breggin's opinions do not rise to the level of an opinion based on 'good science.'"[49][50] [51]

However, according to The Denver Post, the judge of the case "...was visibly angry that the experts failed to view evidence prior to their depositions" even though they had months to do so. The evidence would have included hundreds of documents including a significant amount of video and audio tape that the killers had recorded. The judge stated, "...lawyers will be free to attack them on the basis of the evidence they haven't seen and haven't factored into their opinions."[53] The lawsuit was eventually dropped with the stipulation that the makers of Luvox donate $10,000 to the American Cancer Society.[52]

n 2005, the Philadelphia County Court of Common Pleas disqualified the testimony of Breggin because it did not meet the scientific rigor established by the Frye standard. The judge stated "...Breggin spends 14 pages critiquing the treatment provided not because it ran counter to the acceptable standards of care, but because it ran counter to Breggin's personal ideas and ideologies of what the standards ought to be.”[54]

By al kimeea (not verified) on 29 Nov 2012 #permalink

Some of your statements are not factual.
Which statements are not factual? Be specific.

Regardless, if you hold a single person so much accountable when evidences for a myriad of similar or even worse practices exist , my answer to your question would be Yes.

Would you argue we should not spend time and resources addressing domestic abuse and burglary as long as murders and armed robberies occur? A simple yes or no answer would be appreciated.

It will be Yes until you realize how hypocritically you act by showing double standards.

Strawman fallacy--what double standard could you be talking about? No one here, and certainly not me, is arguing pharmaceutical companies should not be held accountable if and when they act in an unethical or illegal manner.

Here is more interesting reading

Ooh, a link to HuffPo. Thanks, I'll pass.

Didymus Judas Thomas, most of those are ongoing and not final reports. Did you even read the titles when you cut and pasted? The last one is just an editorial.

Now pick out one that proves Burzynski's form of chemotherapy works better than present treatments. Just one, and quote the results.

As a comparison, tell us if it works better than Gleevec does for chronic myelogenous leukemia for the condition that the one report you choose is about.

Then go and find out what happened to the Phase 3 clinical trial. How many subjects have they recruited? Are they charging them?

Jim,

Shifting the focus is a very convenient strategy.

It doesn't seem to be working out too well for you.

By Krebiozen (not verified) on 29 Nov 2012 #permalink

Diddums, your Gish Gallup shows exactly what? Self-promotion of Burzynski, old and failed trials for safety and efficacy and zero replication. After 30+ years of this scam he still doesn't have FDA approval.

By Science Mom (not verified) on 29 Nov 2012 #permalink

Did you actually follow up on the links you provide in your post above, Didymus, or did you just copy-pasta from some pro-Burzxynski website? These citations don’t ptovide any evidence Burzynski’s antineoplastin protocols are safe or effective treatments for cancer.

They’re either review articles (e.g. “Antineoplastons: history of the research”, “Treatments for astrocytic tumors in children: current and emerging strategies”, etc.) or published abstracts from presentations or posters Burzynski ‘s given at different conferences which have not undergone perr-review ( e.g., “The present state of antineoplaston research”,“Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme”.,”Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report” , “Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1”, etc.)

What they are not is peer-reviewed publications providing data or analysis from any of the ‘clinical trials’ Burzynski’s supposedly been conducting for the past several decades, demonstrating that antineoplastins are either safe or effective as a treatment for advanced (or for that matter any ) cancers.

Science Mom:

After 30+ years of this scam he still doesn’t have FDA approval.

As opposed to Gleevec. It took less than five years for it to be approved for a couple types of cancer.

JGC, that is why I asked him if he had even read the titles of those papers.

@ Chris:

It's like when anti-SBM prevaricators quote Ben Goldacre: I wonder if they ever even read complete sentences or just fish out random phrases with which they agree.

By Denice Walter (not verified) on 29 Nov 2012 #permalink

the biggest problem advocates of the various woo's face isn't that they have no evidence their preferred brand of woo is effective, it's that they have no idea what evidence it works would look like.

Antaeus Feldspar, please state "FACTS" that support your false claim that I "don't care about cannibalism and murder." The post in question is about SRB and that is what my writings have been directed at. Sure I can criticize Big Pharma first, because I live in The United States of America and have Freedom of Speech. I am not bound to discuss what you may want to discuss as an aside.

Alain, I am glad you are alive. I may possibly be alive for the same reason.

AdamG, I take it that you did not click on the above links that I provided and read the contents thereof. Please view the 1st link re pdpipeline. I am living on planet Earth. What solar system are you living in?

Militant Agnostic, I hope you are not using unsoiled underpants.

al kimeea, the above link I provided re Breggin; which I guess you did not read, is dated 2006 as far as the case. We all know that Wikipedia is a credible resource seeing as how under Burzynski / Legal issues, at the very bottom it cites a "review" where the "reviewer" didn't actually "review" (watch) the movie, but that "FACT" isn't pointed out on Wikipedia. You actually have to click on the [51] link to access the link to the "review" where it admits that the author "hasn't seen the movie."

By Didymus Judas Thomas (not verified) on 29 Nov 2012 #permalink

@Didymus - so, no comment on the fact that the links you provided in PubMed don't say what you think they say?

AdamG, I take it that you did not click on the above links that I provided and read the contents thereof. Please view the 1st link re pdpipeline.

Oh, I read the links. That doesn't change the fact that this statement:

the NIH budget has doubled in the past five years

Is completely, demonstrably false. If you're willing to post such falsehoods, and then double down when caught in an obvious mistake, how am I to trust any of the sources you cite?

It's clear you didn't actually read my link, so here's the actual report from Science on NIH funding:

http://www.sciencemag.org/content/328/5979/676.full

I'm curious, DJT, have you graced us with your enlightening presence before?

The smell of socks is strong with this one.

the above link I provided re Breggin; which I guess you did not read, is dated 2006 as far as the case. We all know that Wikipedia is a credible resource seeing as how under Burzynski / Legal issues, at the very bottom it cites a “review” where the “reviewer” didn’t actually “review” (watch) the movie

Um, something about a review of the Merola infomerical has precisely what to do with your LOOK A SQUIRREL injection of Breggin going on in the eminently "credible resource" HuffPo?

Didymus Judas Thomas, come on! Cite and quote which one of those papers in your Gish Gallop shows that Burzynski's treatment works as well as Gleevec for its specific kind of cancer. At least one was for leukemia.

Christ:
Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published.

Didymus Judas Thomas:
Chris, here are the PubMed’s:
[...]

I hope it is not unduly pedantic to point out that anything labeled "Preclinical studies" or "Toxicology study" is not clinical results.

By herr doktor bimler (not verified) on 29 Nov 2012 #permalink

Chris, do you have any "FACTS" supporting your innuendo that I did not read the titles? Please explain why I should "pick out one." After all, I have not yet seen your apology and you have not used the "Magic Word." You do know what the "Magic Word" is, right, Chris? The "Magic Word" is "Please."

Science Mom, have you read my previous post & links re the difficulties, time, and expense involved in obtaining FDA approval? Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial? And that amount may have risen since then.

JGC, please explain how I would have been able to provide the above links without following up on them. Have you reviewed Burzynski's sites to determine if the links are there?

Lawrence, "links ... don't say what [I] think they say?" Please cite where I said what the links would say.

AdamG, please cite the "FACTS" which buttress your unproven inane statement that "It's clear that [I] didn't actually read [your] link. When viewing that site were you able to draw a conclusion as to what years the NIH statement was referring to? I think the more important part of the statement is the part re the FDA. I'm not even going to waste my time answering your last question since I answered your question about what planet I live on but you did not answer my question about what solar system you're from.

Narad, since al kimeea brought up wiki I commented on the credibility of information on wiki re Burzynski since this post is about SRB. I brought up Breggin since his comments on HuffPo are re Big Pharma. I also construed Breggin's comments re no requirement for drug co's to disclose certain information, as also applying to SRB.

Chris, I actually do other things during the day other then feverishly monitor what comments are being posted here. My statement at the top of this applies.

herr doktor bimler, where does Chris' post state "clinical results?" It states "clinical." As far as I'm concerned that left it up to my discretion as to what to choose to post.

By Didymus Judas Thomas (not verified) on 29 Nov 2012 #permalink

JGC, please explain how I would have been able to provide the above links without following up on them.

Perhaps by going to the list of publications on the Burzinsky clinic website (www.burzynskiclinic.com/publications.html) and then pulling up the pubmed links without looking further? OR maybe you got lucky amd simply cut and paste the list with the pubmed links intact from one of the many websites Burzynski's marks, convinced he's the real deal, have set up to promote his clinic.

The real question, if we accept you did actually follow up and examine the citations you've offered, is however did you fail to realize they offer no evidence antineoplastins are safe or effective?

Diddums, you said:

"herr doktor bimler, where does Chris’ post state “clinical results?” It states “clinical.” As far as I’m concerned that left it up to my discretion as to what to choose to post."

Lets look at what Chris said:

"Tell me the title, date and journal of the PubMed indexed paper where the RESULTS of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants."

To make it easy I have capitalized the relevant word in Chris's request.

Still having difficulty Diddums?

We will await the data.

As far as I’m concerned that left it up to my discretion as to what to choose to post.

*Of course* it's up to you what information you link to, whether or not it's relevant or persuasive. This is an internet comment thread -- not a Wikipedia page where someone else will delete your contributions if they're bullsh1t.

By herr doktor bimler (not verified) on 29 Nov 2012 #permalink

When viewing that site were you able to draw a conclusion as to what years the NIH statement was referring to?

Given that the article was written in 2012, and that the statement refers to the past 5 years, the article is clearly claiming that the NIH budget doubled in the period from 2007-2012.

Do you believe that this is a factual claim or not? If so, please cite the “FACTS” that support this unproven inane statement.

For someone so focused on facts and proof, why won't you acknowledge that this is an erroneous statement?

The “Magic Word” is “Please.”

I thought the magic word was "abracadabra".

Is it me or does this smack of a pyramid scheme? Like in the mob where there are levels of people below the boss, so that the boss is forever covered should the law ever get near prosecuting someone...

The last time it did was back in the 1990s. Will it be in the 2020s before a future board decides to try again, or will Burzynski retire or die before then, leaving his son Greg to carry on the family business?

I'm betting on sonny-boy.

@Edith

As far as I’m concerned: until Burzynski’s shut down for good, Orac can’t write often enough about him.

I agree!

@Todd W

It would be nice to have them do something about the clinical trials themselves, given how long they’ve been going with zero published results and no wrap-up date in sight. Honestly, not certain what the hold up is, there.

Forgive my ignorance, but are studies allowed to be open-ended in terms of time scales? Is there any regulation that says the study lasts X long, and after that date, you need to get an extension and/or end the study? And if extensions exist, are there any limits on how long/how many you can get?

@Roger

He/she has never even there during this legal process.

Last Thursday-ism, love it! That's not been used for a while...

Also (and @Jim)

Science ≠ law

@Jim

But we already knew surgeons are pretty biased …

Well, that's evidence that Burzyinski's treatments work...

Don’t try to represent science as the only true solution to all problems – it is not.

Lovely, now we have the "other ways of knowing" fallacy.

You know nothing about how exactly the human body functions at molecular level, as does Dr. Burzynski.

Cue the word, "quantum".

I’m talking about different spatial and temporal scales – access to which will provide a complete picture of the molecular processes within the human body.

Close enough...

When exactly the money is taken, before, during or after a clinical trial, is irrelevant from a patient’s point of view.

Yeah, that's not how it works. Patients do not pay anything, before, during or after a clinical trial. Private and public donors might, but that's not quite the same thing: and you know it.

Burzynski is not that different – sooner or later he will show you the data, what’s the problem?

I guess people take issue with it being 'later'. 30 years is enough time to show evidence of some kind - why wait so long?

God of Science

And now we have the "science is religion" fallacy.

Whatever else topic you implied or tried to propagate to me remained somewhat irrelevant and I did not really feel you talked to me.

And now the flounce...

@JBC

If I hire someone to kill my spouse, I am guilty of murder as I understand it. How is this different?

I'm guessing the assumption is that each doctor (should) take it upon him/herself to treat the patient according to their own knowledge/experience/conscience, and that therefore have more individual responsibility. IANAL or doctor, but that would be my guess.

@Didymus Judas Thomas

You are hilarious - but quite outmatched. Your debate tactics seem to be 'argue semantics' rather than 'argue the point'.

@flip

Forgive my ignorance, but are studies allowed to be open-ended in terms of time scales? Is there any regulation that says the study lasts X long, and after that date, you need to get an extension and/or end the study? And if extensions exist, are there any limits on how long/how many you can get?

To my recollection, there are no such laws. However, IRBs who are doing their jobs would normally take a look at subject enrollment and expected targets, then decide that if enrollment is stagnant for some period of time, that perhaps the study should be closed, unless there is some very compelling reason to keep it open.

One way that his trials might be shut down is to target the IRB. If they persist in violating IRB regulations, they could be stripped of their approval. If that happens, then he would need to find a new IRB to oversee his studies. If he doesn't do that, then his studies would be illegal, as they would be operating without IRB approval.

Narad, since al kimeea brought up wiki I commented on the credibility of information on wiki re Burzynski since this post is about SRB. I brought up Breggin since his comments on HuffPo are re Big Pharma. I also construed Breggin’s comments re no requirement for drug co’s to disclose certain information, as also applying to SRB.

No, Peaches, you got asshurt over having pointed out that Breggin, who you invoked to persist in trying to change the subject, is a crank, pouted about his being "a medical expert in a number of product liability suits against drug companies," then cranked up the pissiness when it was pointed out that he's proved to be a really sh*tty expert witness and tried to impugn the source by observing that Wikipedia linked to a bad review of the Burzynski movie that you were able to find fault with. That's a really f*cking impressive gotcha.

It was colossally stupid to invoke Breggin in the first place, as he's completely unnecessary to the diversionary maneuver, and you just kept piling it on.

^ "having it pointed out"

No real sciency comment to make so I'll chuck in an Ad Hom.

We really should refer to DJT as Epi. It's the nearest to Balls as anything I've ever read on this fine site. (Stand Fast Dana Ullman)

Epi and dydimous. Did you see what I did there?

@ Peebs:

You are so correct.

By Denice Walter (not verified) on 29 Nov 2012 #permalink

Given that the article was written in 2012, and that the statement refers to the past 5 years, the article is clearly claiming that the NIH budget doubled in the period from 2007-2012.

The only period since 1980 that the claim can accurately refer to is 1998–2003, which makes one wonder why it's being parroted right here and right now. Actually, scratch that last bit.

Didymus Judas Thomas:

Chris, do you have any “FACTS” supporting your innuendo that I did not read the titles? Please explain why I should “pick out one.” After all, I have not yet seen your apology and you have not used the “Magic Word.” You do know what the “Magic Word” is, right, Chris? The “Magic Word” is “Please.”

The fact that you claimed that some papers were results, when the titles clearly indicated they were not. I even included one of those titles. Now here it is again with some others:

ntineoplastons: history of the research (I).

Preclinical studies on antineoplaston AS2-1 and antineoplaston AS2-5.

Toxicology studies on antineoplaston AS2-5 injections in cancer patients.

Toxicology studies on antineoplaston AS2-1 injections in cancer patients.

Toxicology studies on antineoplaston A10 injections in cancer patients.

Chronic animal toxicity studies on antineoplaston A2.

Potential of antineoplastons in diseases of old age.

The present state of antineoplaston research (1).

Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme.

Treatments for astrocytic tumors in children: current and emerging strategies

Stanislaw R. Burzynski, MD, PhD: novel cancer research and the fight to prove its worth.

From reading the titles, I can see none of them are results of a full clinical trial. In fact, in some of the papers claiming to be "results" were actually opinion pieces. You were asked specifically before you posted that Gish Gallop:

Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.

Though I did skip the word "trials" after the word "clinical." This is a blog, typos and dropped words happen.

Now, please cite one paper that shows the clinical results that match the efficacy of Gleevec. And do you have an answer as to why the Phase 3 clinical trial is not allowing participants?

All of a sudden, I'm getting a strong penny-stock vibe off of DJT.

@ Narad:

Or-
DJT Dow Jones Transportation ( average)

By Denice Walter (not verified) on 29 Nov 2012 #permalink

- btw-
That is not- in any shape or form- advice.

By Denice Walter (not verified) on 29 Nov 2012 #permalink

Science Mom, have you read my previous post & links re the difficulties, time, and expense involved in obtaining FDA approval?

Believe it or not, I'm quite familiar with the FDA approval process and I'm not exactly feeling sorry for rich old Burzynski who has made his nut off the backs of desperate people. He has chosen to make claims of miracle cure then he had better have something to show for it; no one is keeping him from doing so.

Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial? And that amount may have risen since then.

But of course, let's decide treatment merit based upon a self-promoted and aggrandised movie. In fact, screw peer review and regulation, let's pass drugs onto consumers based upon YooTube vids.

Aww, and poor wittle Burzynski sitting in his gauche mansion. What do you think venture capitalists are for Diddums? If he had such a great product, he would have no trouble getting investors. Why doesn't he?

By Science Mom (not verified) on 29 Nov 2012 #permalink

Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial?

Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial, and that his application to do so -- and his claim to be recruiting subjects -- are fraudulent?

By herr doktor bimler (not verified) on 29 Nov 2012 #permalink

Antaeus Feldspar, please state “FACTS” that support your false claim that I “don’t care about cannibalism and murder.” The post in question is about SRB and that is what my writings have been directed at. Sure I can criticize Big Pharma first, because I live in The United States of America and have Freedom of Speech. I am not bound to discuss what you may want to discuss as an aside.

Wow, you really don't have much self-awareness, do you?

We are discussing Burzynski. You are the one coming along and trying to tell us that we are violating some principle or other if we discuss Burzynski rather than Big Pharma, and that our violation of that principle indicates that we don't want to hold Big Pharma responsible for its misdeeds.

My mocking suggestion that, if you wanted to focus attention on Big Pharma rather than cannibalism and murder, you would be violating a similar principle and indicating you didn't want to hold murderous cannibals responsible for their acts, is what's called a reductio ad absurdam. It's a way of saying "your logic is BS, because you can apply it to a valid set of premises and yet reach this completely absurd conclusion."

I'm afraid I made a mistake in assuming you could think clearly enough to draw the obvious connection between what you were facetiously accused of and what you had just accused us of. I'll try not to overestimate you like that in the future.

By Antaeus Feldspar (not verified) on 29 Nov 2012 #permalink

hdb:

Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial, and that his application to do so — and his claim to be recruiting subjects — are fraudulent?

Especially since Burzynski actually charges the patients the cost of the clinical trial.

Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial, and that his application to do so — and his claim to be recruiting subjects — are fraudulent?

Nice catch HDB. Perhaps Diddums will be along to throw another shiny object in our paths to avoid answering this.

By Science Mom (not verified) on 29 Nov 2012 #permalink

There's really only two possibilities I see: either Burzynski's decades of clinical trials have produced no evidence antineoplastins work or evidence they don't work, inwhich case he's s a fraud, or they've shown they do work but he's withholding publication to ensure a monopoly for his clinic thereby denying millions of cancer patients access to his miracle cure

In which case of course he's a monster.

@Todd W

Thanks - so it's clear to me that if the IRB is corrupt, then the studies have very little chance of being done properly?

This is a test since I submitted a response to JGC over 4 hours ago which indicated it was under review for posting but hasn't posted. So, I am seeing if my posting is being denied, or what.

By Didymus Judas Thomas (not verified) on 29 Nov 2012 #permalink

@didymus - if you are unaware (and you mostly like are), there is a comment filter in place that activates under certain circumstances (key words for example, or too many links) to prevent the spamming of this blog.

The blog author isn't a machine (well, mostly not a machine, lol) and gets to the held comments when he is able.

So, how about a real retort instead of whining.

JGC, did you actually access the link you provided? Because there are no links on the Publication page to PubMed. Please advise which SRB site has links to PubMed and/or matches the list I made from:
www.ncbi.nlm.nih.gov/m/pubmed
Please explain to me how & when it became my responsibility to state an opinion re the efficacy of Antineoplastons (not Antineoplastins). Don't take my word for it, read what the National Cancer Institute at the National Institutes of Health:
www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2
and American Cancer Society says:
http://m.cancer.org/treatment/treatmentsandsideeffects/complementaryand…

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

And we can ask why there's been so much research and patents issued re Antineoplastons:
www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/…
Non-SRB Antineoplaston 1986-1989 (in date order):
Preclinical studies on antineoplaston A10 injections. Ashraf AQ, et al. Drugs Exp Clin Res. 1986
www.ncbi.nlm.nih.gov/m/pubmed/3743379
3-Phenylacetylamino-2,6-piperidinedione, a naturally-occurring peptide analogue with apparent antineoplastic activity, may bind to DNA. Lehner AF, et al. Drugs Exp Clin Res. 1986
www.ncbi.nlm.nih.gov/m/pubmed/3743381
Altered methylation complex isozymes as selective targets for cancer chemotherapy. Liau MC, et al. Drugs Exp Clin Res. 1986
www.ncbi.nlm.nih.gov/m/pubmed/3743383
In vitro cancer growth inhibition and animal toxicity studies of antineoplaston A3. Lee SS, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569011
Tissue culture and animal toxicity studies of antineoplaston A5. Lee SS, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569013
Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Ashraf AQ, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569015
Chemoprevention by antineoplaston A10 of benzo(a)pyrene-induced pulmonary neoplasia. Kampalath BN, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569016
N,N'-disubstituted L-isoglutamines as novel cancer chemotherapeutic agents. Khalid M, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569017
Quantitative assay of plasma and urinary peptides as an aid for the evaluation of cancer patients undergoing antineoplaston therapy. Liau MC, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569018
Chemo-surveillance: a novel concept of the natural defence mechanism against cancer. Liau MC, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569019
Stereochemical modelling studies of the interaction of antineoplaston A10 with DNA. Hendry LB, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569020
Inhibition of spontaneous mouse mammary tumour development by antineoplaston A10. Muldoon TG, et al. Drugs Exp Clin Res. 1987
www.ncbi.nlm.nih.gov/m/pubmed/3569021
Actions of an endogenous antitumorigenic agent on mammary tumor development and modeling analysis of its capacity for interacting with DNA. Hendry LB, et al. J Steroid Biochem. 1988
www.ncbi.nlm.nih.gov/m/pubmed/3133525
Chemopreventive effect of antineoplaston A-10 on urethane-induced pulmonary neoplasm in mice. Eriguchi N, et al. Nihon Gan Chiryo Gakkai Shi. 1988

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

Non-SRB Antineoplaston 1990-1999 (in date order)
Theoretical investigations on the structure and potential binding sites of antineoplaston A10 and experimental findings. Michalska D, et al. Drugs Exp Clin Res. 1990
www.ncbi.nlm.nih.gov/m/pubmed/2092960
Pharmacokinetic study of radioactive antineoplaston A10 in rats and mice. Xu W, et al. Drugs Exp Clin Res. 1990
www.ncbi.nlm.nih.gov/m/pubmed/2092961
Studies of the release rate and bioavailability of antineoplaston A10 capsule. Wang H, et al. Drugs Exp Clin Res. 1990
www.ncbi.nlm.nih.gov/m/pubmed/2092962
The anticancer effect of antineoplaston A-10 on human breast cancer serially transplanted to athymic mice. Hashimoto K, et al. Nihon Gan Chiryo Gakkai Shi. 1990
www.ncbi.nlm.nih.gov/m/pubmed/2157780
Inhibitory effect of antineoplaston A-10 on breast cancer transplanted to athymic mice and human hepatocellular carcinoma cell lines. The members of Antineoplaston Study Group. Tsuda H, et al. Kurume Med J. 1990
www.ncbi.nlm.nih.gov/m/pubmed/2175003
3-phenylacetylamino-2,6-piperidinedione inhibition of rat Nb2 lymphoma cell mitogenesis. Wood JC, et al. Proc Soc Exp Biol Med. 1991
www.ncbi.nlm.nih.gov/m/pubmed/1871151
[Antineoplastons--structure, chemical properties and mechanism of activity]. Kochman A, et al. Postepy Hig Med Dosw. 1992. Article in Polish.
www.ncbi.nlm.nih.gov/m/pubmed/1308583
The inhibitory effect of the combination of antineoplaston A-10 injection with a small dose of cis-diamminedichloroplatinum on cell and tumor growth of human hepatocellular carcinoma. Tsuda H, et al. Jpn J Cancer Res. 1992
www.ncbi.nlm.nih.gov/m/pubmed/1377669
'Antineoplastons'. An unproved cancer therapy. Green S, et al. JAMA. 1992
www.ncbi.nlm.nih.gov/m/pubmed/1583762
Inhibition of estrogen stimulated mitogenesis by 3-phenylacetylamino-2,6-piperidinedione and its para-hydroxy analog. Copland JA, et al. J Steroid Biochem Mol Biol. 1993
www.ncbi.nlm.nih.gov/m/pubmed/8217876
The influence of antineoplaston A5 on the central dopaminergic structures. Juszkiewicz M, et al. Drugs Exp Clin Res. 1994
www.ncbi.nlm.nih.gov/m/pubmed/7813388
Antiestrogenic piperidinediones designed prospectively using computer graphics and energy calculations of DNA-ligand complexes. Hendry LB, et al. J Steroid Biochem Mol Biol. 1994
www.ncbi.nlm.nih.gov/m/pubmed/8180110
Synthesis of Mannich bases of antineoplaston A10 and their antitumor activity. Choi BG, et al. Arch Pharm Res. 1994
www.ncbi.nlm.nih.gov/m/pubmed/10319160
The effect of Antineoplaston, a new antitumor agent on malignant brain tumors. Sugita Y, et al. Kurume Med J. 1995
www.ncbi.nlm.nih.gov/m/pubmed/7474850
Cellular accumulation of antineoplaston AS21 in human hepatoma cells. Sołtysiak-Pawłuczuk D, et al. Cancer Lett. 1995
www.ncbi.nlm.nih.gov/m/pubmed/7850766
The influence of antineoplaston A5 on particular subtypes of central dopaminergic receptors. Juszkiewicz M, et al. Drugs Exp Clin Res. 1995
www.ncbi.nlm.nih.gov/m/pubmed/8529528
Toxicological study on antineoplastons A-10 and AS2-1 in cancer patients. Tsuda H, et al. Kurume Med J. 1995
www.ncbi.nlm.nih.gov/m/pubmed/8667595
Inhibitory effect of antineoplaston A10 and AS2-1 on human hepatocellular carcinoma. Tsuda H, et al. Kurume Med J. 1996
www.ncbi.nlm.nih.gov/m/pubmed/8755117
3-[(Phenylacetyl)amino]-2,6-piperidinedione hydrolysis studies with improved synthesis and characterization of hydrolysates. Revelle LK, et al. J Pharm Sci. 1996
www.ncbi.nlm.nih.gov/m/pubmed/8897269
Enantioseparation of 3-phenylacetylamino-2,6-piperidinedione and related chiral compounds. Tang Y, et al. J Chromatogr A. 1996
www.ncbi.nlm.nih.gov/m/pubmed/8962498
Lessons from antineoplaston. No authors listed. Lancet. 1997
www.ncbi.nlm.nih.gov/m/pubmed/9091754
Lessons from antineoplaston. Silver H, et al. Lancet. 1997
www.ncbi.nlm.nih.gov/m/pubmed/9164346
Lessons from antineoplaston. Baldwin of Bewdley, et al. Lancet. 1997
www.ncbi.nlm.nih.gov/m/pubmed/9164347
Lessons from antineoplaston. Fahner JB, et al. Lancet. 1997
www.ncbi.nlm.nih.gov/m/pubmed/9164348
Lessons from antineoplaston. Tweddle S, et al. Lancet. 1997
www.ncbi.nlm.nih.gov/m/pubmed/9164349
Antineoplaston AS2-1 for maintenance therapy in liver cancer. Tsuda H, et al. Oncol Rep. 1997
www.ncbi.nlm.nih.gov/m/pubmed/21590224
Quick response of advanced cancer to chemoradiation therapy with antineoplastons. Tsuda H, et al. Oncol Rep. 1998
www.ncbi.nlm.nih.gov/m/pubmed/9538158
[Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing panencephalitis]. Sobczyk W, et al. Neurol Neurochir Pol. 1997. Article in Polish.
www.ncbi.nlm.nih.gov/m/pubmed/9591301
Antineoplaston treatment for advanced hepatocellular carcinoma. Kumabe T, et al. Oncol Rep. 1998
www.ncbi.nlm.nih.gov/m/pubmed/9769368
Synthesis of antineoplaston A10 analogs as potential antitumor agents. Choi BG, et al. Arch Pharm Res. 1998
www.ncbi.nlm.nih.gov/m/pubmed/9875424
Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Buckner JC, et al. Mayo Clin Proc. 1999
www.ncbi.nlm.nih.gov/m/pubmed/10069350
[The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis]. Sobczyk W, et al. Neurol Neurochir Pol. 1999. Article in Polish.
www.ncbi.nlm.nih.gov/m/pubmed/10612094

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

Non-SRB Antineoplaston 2000-2009 (in date order)
Potential utility of antineoplaston A-10 levels in breast cancer. Badria F, et al. Cancer Lett. 2000
www.ncbi.nlm.nih.gov/m/pubmed/10814881
Immune modulatory potentials of antineoplaston A-10 in breast cancer patients. Badria F, et al. Cancer Lett. 2000
www.ncbi.nlm.nih.gov/m/pubmed/10893443
Pharmacologic and biologic therapies in cancer care. Decker GM, et al. Clin J Oncol Nurs. 2000
www.ncbi.nlm.nih.gov/m/pubmed/11111459
Novel piperidinedione analogs as inhibitors of breast cancer cell growth. Abou-Zeid LA, et al. Arch Pharm (Weinheim). 2000
www.ncbi.nlm.nih.gov/m/pubmed/11199474
Synthesis, spectroscopic characterization, stability assessment and DNA-binding of new 2,6-piperidinedione derivatives. Abou-Zeid L, et al. Farmaco. 2001
www.ncbi.nlm.nih.gov/m/pubmed/11718269
A novel strategy for remission induction and maintenance in cancer therapy. Tsuda H, et al. Oncol Rep. 2002
www.ncbi.nlm.nih.gov/m/pubmed/11748457
The preventive effect of antineoplaston AS2-1 on HCC recurrence. Tsuda H, et al. Oncol Rep. 2003
www.ncbi.nlm.nih.gov/m/pubmed/12579278
Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case. Ogata Y, et al. Surg Today. 2003
www.ncbi.nlm.nih.gov/m/pubmed/12768372
[Anti-proliferative effects of biochemical defense modifier antineoplaston in colorectal carcinoma]. Ogata Y, et al. Nihon Rinsho. 2003. Article in Japanese.
www.ncbi.nlm.nih.gov/m/pubmed/14574945
Managing social conflict in complementary and alternative medicine research: the case of antineoplastons. Hammer MR, et al. Integr Cancer Ther. 2004
www.ncbi.nlm.nih.gov/m/pubmed/15035877
Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer in nude rat. Matono K, et al. Oncol Rep. 2005
www.ncbi.nlm.nih.gov/m/pubmed/15706406
[The regulatory action of dipeptide "Deglutam" on the glutamine metabolized enzymes in the carcinosarcoma SM-1 cells]. No authors listed. Biomed Khim. 2005. Article in Russian.
www.ncbi.nlm.nih.gov/m/pubmed/15850218
Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells. Fujii T, et al. Oncol Rep. 2005
www.ncbi.nlm.nih.gov/m/pubmed/16012735
Induction of apoptosis in human hepatocellular carcinoma cells by synthetic antineoplaston A10. Qu XJ, et al. Anticancer Res. 2007
www.ncbi.nlm.nih.gov/m/pubmed/17695534
Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer. Fujii T, et al. Breast Cancer. 2008
www.ncbi.nlm.nih.gov/m/pubmed/18224398
Precise engineering of targeted nanoparticles by using self-assembled biointegrated block copolymers. Gu F, et al. Proc Natl Acad Sci U S A. 2008
www.ncbi.nlm.nih.gov/m/pubmed/18272481
Novel aminopeptidase N inhibitors derived from antineoplaston AS2-5 (Part I). Li X, et al. Bioorg Med Chem. 2009
www.ncbi.nlm.nih.gov/m/pubmed/19329328
Novel aminopeptidase N inhibitors derived from antineoplaston AS2-5 (Part II). Li X, et al. Bioorg Med Chem. 2009
www.ncbi.nlm.nih.gov/m/pubmed/19339187

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

@flip

Thanks – so it’s clear to me that if the IRB is corrupt, then the studies have very little chance of being done properly?

It's not a surety, but it definitely ups the likelihood. Remember, the IRB is there to ensure that subjects are protected. They have the authority to shut down a study if the investigator and/or anyone else on the study is screwing up. If the IRB is not doing their job properly, then the risk to subjects goes up as the potential for PI shenanigans goes unchallenged.

In Burzynski's case, the IRB overseeing his research was cited on quite a number of violations:

1) They did not ensure that risks were minimized and reasonable compared to anticipated benefits/knowledge to be gained.
2) They did not have written procedures for initial/continuing review of research involving a medical device. (Apparently, at least one study involved medical devices.)
3) They did not ensure that informed consent would be sought or documented.
4) They had voting IRB members who were directly involved in the research being reviewed (Carlton F. Hazlewood, the IRB's chair, is an investigator on one study and advisor on the DSMB. Another IRB member was a coinvestigator of another study.)
5) They did not conduct continuing reviews for a couple studies, instead having only verbal conversations with the PI.
6) They did not keep complete copies of all study-related documents (protocols, consent forms, etc.).
7) They did not keep minutes of their meetings, recording who attended, who voted, basis for changes/disapproval, or discussion summaries of controverted issues and how they were resolved.
8) They allowed non-IRB members to vote in place of individuals who had conflicts of interest.

These violations were all documented in a letter to the IRB dated October 5, 2009. No close-out letter is recorded, meaning that either FDA just didn't post it, or the deficiencies listed in the warning letter have not yet been corrected or any corrective actions have not yet been verified by FDA inspectors.

@DJT

You said, emphasis added:

And we can ask why there’s been so much research and patents issued re Antineoplastons

You do realize that a patent being issued has absolutely nothing to do with whether or not something actually works, right? All it means is that someone really wanted to protect the invention or method from other people trying to do something with it without first getting permission. That's all a patent does.

@DJT: Until you can prove to us ONE of those many copy/pasta links shows that antineoplastins are: 1)nontoxic (the only real study I know about them closed early due to toxicity) 2)effective at safe levels (not found) 3)safer and more effective than current treatments (not proven) then all you are doing is spamming.

Chris asked you many comments ago for ONE clinical study that showed antineoplastins were as or more effective than the fast-tracked chemotherapy drug. You haven't answered that. Why not? And no, it's NOT our job to find the study. You made the claim, you provide the proof. That's how it goes (AKA: CITATION NEEDED).

Otherwise, we'll just assume you are trolling. We aren't as vicious to chew toys as they are on Pharyngula, but we do have fun with them.

Oh, and I should have added - please show you also know the difference between in-vitro and in-vivo studies....

@Didymus

Oh holy hell Batman, no wonder your comments ended up being delayed... Try fewer links next time.

@Todd W

It’s not a surety, but it definitely ups the likelihood.

Of course - with lax oversight there's more opportunity to screw up, with more oversight there's more opportunity to fix the screw ups.

But if the IRB in this case isn't paying attention to the 'no results for 30 years' thing, then shutting down the study isn't very likely is it?

Remember, the IRB is there to ensure that subjects are protected.

And in this case, it's not doing much of anything to protect them from fee-gouging or from paying to be in clinical trials.

In Burzynski’s case, the IRB overseeing his research was cited on quite a number of violations:

So basically if the IRB isn't doing their job properly, all they get is a letter? (Presumably law cases come after numerous letters) So the FDA/etc are really quite toothless in this whole case...

Yes, I did go the the clinic's website and noted taht it didn't include the pubmed links; as you recall I suggested puled up the links from pubmed and appended them to the titles before posting them here, without actually investigating the articles further. That's the only way I can imagine you'd offer these articles, which represent review articles, poster abstracts and opinion pieces and don't present any clinical study results, in response to Chris' question "Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published."

Please explain to me how & when it became my responsibility to state an opinion re the efficacy of Antineoplastons (not Antineoplastins).

You've voluntarily expressed an opinion regarding antineoplastons, by arguing we should cese criticizing Burzynski's clinic and simply wait and see. Surely that isn't what you'd advise if you did not beleive they were potentially a safe and efficacious treatment for the advanced cancers his patients present?

By the way, which do you think he is-- fraud, who is witholding publishing the results of his clinical trials because they provide evidence of antineoplastons efficacy, or a monster who's witholding publication to maintain a very lucrative monopoly, thereby denying thousands of cancer victims access to the cure?

@flip

Not sure what action has been taken to follow-up on that letter. I'd need to file a FOIA request. If the deficiencies are not resolved, the IRB's registration or assurance could be revoked, meaning that they would not be able to review/approve any research that falls under the Common Rule. That would mean that any research he conducts that is approved by that IRB would not be able to be used for approval by FDA, nor would he be able to get any funding support from any agency that falls under the Common Rule.

Minor correction to my last comment. FDA has its own set of IRB requirements separate from the Common Rule. Some differences are noted here.

The FDA can disqualify an IRB for failure to comply with regulations. If that happens, then:

(d) The Food and Drug Administration will not approve an application for a research permit for a clinical investigation that is to be under the review of a disqualified IRB or that is to be conducted at a disqualified institution, and it may refuse to consider in support of a marketing permit the data from a clinical investigation that was reviewed by a disqualified IRB as conducted at a disqualified institution, unless the IRB or the parent institution is reinstated as provided in 56.123.

I was unable to find his IRB listed as registered, which may partially explain why he's not pursuing FDA approval. Again, though, some info may not be available online, in which case a FOIA request to find out the details would be a better way to go.

Didymus Judas Thomas. how come you did not provide the one paper showing the clinical trial results that show Burzynski's treatment is as effective as Gleevec, with direct quotes from the paper about the effectiveness?

Seriously how does a paper with a title like (going up to check the Gallop Gish) "Synthesis, spectroscopic characterization, stability assessment and DNA-binding of new 2,6-piperidinedione derivatives" in any the results of any clinical trial? How is one case report as in "Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case." about a full clinical trial?

Come on, just one paper with a direct quote showing effectiveness equivalent to Gleevec for its particular type of cancer. If you do not answer as the question is asked, then we know that there are none.

Sir Didddimus? I gotta warn you, flooding the arena doesn't work with this group.

Also, Didymus Judas Thomas, you have failed to answer why the Phase 3 clinical trial has no participants.

Didy wrote:

Don’t take my word for it, read what the National Cancer Institute at the National Institutes of Health:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2
and American Cancer Society says:
http://m.cancer.org/treatment/treatmentsandsideeffects/complementaryand…

I guess Didy didn't bother to read those information sheets either, as they both conclude that there is no evidence that Stan's antineoplastons have any postive effect. Just because these two cancer organizations provide an information page about ANP on their websites does not mean they endorse, recommend or support this form of unproven, untested "treatment." The information sheets are merely provided for the benefit of anyone doing research into all the cancer treatments being offered, the good, the bad, and the useless. They appear to me to be more of a warning AGAINST Stan's little shop of horrors than an endorsement.

By Marc Stephens … (not verified) on 30 Nov 2012 #permalink

And we can ask why there’s been so much research and patents issued re Antineoplastons

Given that you plainly didn't understand the papers you posted the first time around and apparently don't grasp why that's important, I suppose it would have been a bit much to expect the ability to extract information from journal titles or author lists, either.

Here's a hint: When you see three identically titled Lancet articles in a row, they're not original work. Moreover, "Baldwin of Bewdley" as author should really be a flag. However, I think it's equally hilarious that you disgorged this one as an example of extramural antineoplaston "research."

Marc Stephens Is Insane:

I guess Didy didn’t bother to read those information sheets either,

Which is precisely why I want him to provide direct quotes from the one paper that shows clinical trial results are as effective as Gleevec for the cancer the paper is about.

He seems to have trouble understanding the question, and understanding that the titles on the Gish Gallop he posted are not results of full clinical trials.

Narad:

Here’s a hint: When you see three identically titled Lancet articles in a row, they’re not original work. Moreover, “Baldwin of Bewdley” as author should really be a flag.

He never checked them, they are comments on an article, most likely not in support of Burzynski. Actually, he is having trouble with vocabulary, especially the concept of the "one." One, as in a number between zero and two.

Internet search of Antineoplaston Patent US6013278 displays SRB's patent. Patent search of US Patent & Trademark Office site re 6013278 displays SRB's patent, patent search on "Antineoplastons" displayed 33 patents, on "Antineoplaston" displayed 573 patents, & trademark search on "Antineoplaston" displays SRB's trademark.
Antineoplaston (Dr Samid): ralphmoss . com / html / burz9 . shtml
Internet search of "ResearchproposalfromDrSamid.pdf" will display link for [PDF] "uniformed services university of the health sciences" Samid's letter re Antineoplaston.
Internet search of patent "0725635" displays patent re Antineoplaston (Samid-GOVT OF USA as represented by the SCTY OF DEPT OF HHS), the 11 patents SRB contends the US issued to duplicate his patent.
Orac writes: "[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy..." What's your point? Internet search on "Antineoplastons" "a form of chemotherapy" displays a google 2006 books link re "Get Healthy Now" (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy.
Now to respond to comments! :-)

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

Didy,

Read our lips: patents mean nothing. Anyone can patent anything, if they thought of it first (except for a perpetual motion machine--they are "unpatentable.") The patent office doesn't give a crap if anything works or not.

And a Ralph Moss reference? Sheesh. What's next? Whale.to? Mike Adams? Mercola?

By Marc Stephens … (not verified) on 30 Nov 2012 #permalink

Didy,

What's your motivation behind all this effort to prove something that is unproveable? Do you really think any of us will change our minds based on the links you copy-paste?
Do you work for Burzynski? How much is he paying you to post your comments?

(I love the "reverse Pharma-shill gambit"...)

By Marc Stephens … (not verified) on 30 Nov 2012 #permalink

What’s your point? Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy.

Perhaps you'd like to take a look at the posts of Mr. Saunders, the parent of a Burzynski patient, who was clearly misled into believing that antineoplastins are not chemotherapy. That's the point.

One of the hallmarks of everything pro-Burzynski is that "he doesn't use chemotherapy." I've seen that mantra repeated dozens of times from supporters. It's the single biggest selling point he uses to recruit customers. And he misleads people into thinking there will be no side effects either, while the side effects themselves are often life threatening.

By Marc Stephens … (not verified) on 30 Nov 2012 #permalink

Perusing DJT's citation gishgallop I notice that the number of citations about antineoplastons has been steadily declining, suggesting a steady decrease in interest.
1986-1989 13 citations = 4.3 per year
1990-1999 32 citations = 3.2 per year
2000-2009 18 citations = 1.8 per year
A further check myself also reveals:
2010-2012 1 citation = 0.3 per year
A close examination also reveals there is literally nothing of any substance in there. These are nearly all preclinical, in vitro, or animal studies with a few case reports, a few small uncontrolled studies of patients often also receiving standard treatment, some of unknown status (in Polish for example) and (as Narad noted) one social science study on how one of Burzynski's trials ended up a complete shambles. Smoke and mirrors.

By Krebiozen (not verified) on 30 Nov 2012 #permalink

Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy.

Do we need to go back to the promo copy for the movie?

Antineoplastons are responsible for curing some of the most incurable forms of terminal cancer. Various cancer survivors are presented in the film who chose these medicines instead of surgery, chemotherapy or radiation - with full disclosure of medical records to support their diagnosis and recovery - as well as systematic (non-anecdotal) FDA-supervised clinical trial data comparing Antineoplastons to other available treatments—which is published within the peer-reviewed medical literature.

BTW, how're you coming along on that doubling-of-the-NIH-budget bit?

@Didymus - #1 - the point is Dr. B & his supporters are specifically telling people that his treatment is not Chemo - which is a lie.

#2 - Where are the "PUBLISHED" clinical results that show that Dr. B's treatment is effective vs. conventional cancer treatments?

@Narad - yeah, because I know a lot of researchers that would be very interested to find out that their budgets had, instead of being steadily reduced, were in fact doubled.....

Direct question, DJT: to the best of your knowledge has Burzynski ever published results from a completed Phase II trial of antineoplastons which demonstrates their safety and eficacy at treating advanced cancers?

If so, where?

Hey, who am I?

I will be happy to accept your apology.

Don't forget the magic word, Peaches.

There are some (typical) unbelievable fan comments about Burzynski on the Healthy Home Economist link Orac provided above. In addition to plugs for Simoncini and Cantron, most comments are a response to this first comment from an unhappy former Burzynski patient:

I have experienced this treatment and this case is not the “persecution” you claim. This treatment is NOT harmless! It can be deadly itself. They don’t mention that when you show up. It was $20,000 upfront for the first few days of treatment. How is this not monopolizing?? Like chemo, it makes the patient sick and unable to function normally. It requires a complete overhaul of your life(and diet) and the lives of those around you. Not to mention the antineoplastons WREAK!! I cannot even describe the awful smell that you are subjected to all day, every day. It permeates the house, everything, and everyone it touches. While I’m sure the treatment works for some, so does just a dietary change, so does doing nothing, so does a placebo. The FDA approval doesn’t mean anything. If there’s enough money, the FDA has approved many drugs that are then found to be deadly. In our experience, every patient that we met while there was dead within 2 months of returning home.
I do agree that every patient should have the right to choose their treatment. However, there is a lot of info missing about this particular case and this clinic. The government may not be as unfounded in their case as you are leading people to believe.

There is a follow-up comment about how they never even got to meet Burzynski, etc.

http://www.thehealthyhomeeconomist.com/case-dismissed-alternative-cance…

The website is full of other Mike-Adams-style panic stories about ther perils of wireless baby monitors, Pop-Tarts, and other woo.

By Marc Stephens … (not verified) on 30 Nov 2012 #permalink

Didymus Judas Thomas:

Now to respond to comments!

Since you changed to Gish Galloping with patents, I can assume there are no papers showing results from clinical trials that Burzynski's methods are as effective as Gleevec for any cancer.

You can now apologize for wasting our time.

@Todd W

No need to follow up - I had just meant to explore the issue of IRB loopholes and oversight. It's a side topic that I'm not informed about. Thanks for the links. I can set myself a little light reading when I have more time.

Actually, it makes me wonder about something else. Some years ago I remember havoc in the press due to a UK doctor who had been struck off there, working here in Aus. It concerns me that if Dr B gets royally trounced in the US, he'll simply pack up and move somewhere else. I can guess that different countries might not care (ie. Mexico), but if he say, went to the UK, would he have problems developing research and/or setting up an IRB? As an example, Wakefield is not likely to attract any private or public funding anymore, but do IRBs ever decide to avoid a particular researcher? Can you shop around for IRBs? (Again, showing my ignorance of how this all works...)

@Didymus

What’s your point? Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy.

Well sure, because books and patents are exactly the same as results from double blind placebo trials in a peer-reviewed journal. *rolls eyes

@MSII

While I’m sure the treatment works for some, so does just a dietary change, so does doing nothing, so does a placebo. The FDA approval doesn’t mean anything.

That worries me - they went to him, presumably to treat life threatening cancer, but dietary changes fixed it? Something doesn't smell right. (And it's not the antineoplastons)

@flip

Can you shop around for IRBs?

Short answer, yes, but you're supposed to be open.

Most research centers will have an IRB of their own. However, there are some for-profit IRBs, which carry with them a host of niggly little ethics issues. Sponsors/investigators are supposed to record all IRB interactions, which would include one IRB saying "No way". This info is supposed to be shared with FDA (if going for approval of a new product or indication) or, if they then shop for another IRB, the new IRB.

Even with not-for-profit IRBs, there are two varieties: institutional IRBs (e.g., large universities or academic hospitals will have their own local IRB) and independent IRBs. Both have their potential problems: independent IRBs open the potential for "IRB shopping". You can find a number of articles online about this concern, such as when one IRB disapproves a study and the PI or sponsor looks for one that will approve it. Institutional IRBs remove that risk, but they can create a sort of monopoly on what research gets approved and what doesn't.

DJT Dow Jones Transportation ( average)

Oh, I wasn't kidding. There was what seemed to be an active "let's try to put on a pump-and-dump" scene centered around BZYR for a while. I just happened to note that some of DJT's poorly demarcated quote-barfs also (indeed, exclusively) appeared a while ago in association with PPHM. The former apparently no longer has a market maker and is off the OTCBB.

@Narad

Who knew that Byrzinski Research Institute was a publicly traded company (though I might have known this and forgotten it) with current stocks at $0.10 a share. Interesting find! Wonder what the SEC filings would reveal...

Wonder what the SEC filings would reveal…

Oh, you know, the usual.

The Company has not generated any significant operating revenue since its inception. The Company’s sole source of funding for its operations has been and continues to be payments made by Dr. Burzynski from funds generated from Dr. Burzynski’s medical practice pursuant to various arrangements between the Company and Dr. Burzynski.

@Todd W

Can you shop around for IRBs?

Short answer, yes, but you’re supposed to be open.

Ok, thanks. So if shutting down Burzyinski is also about going after the IRB, then the regulatory bodies need also to make sure he doesn't just grab his 5 next closest buddies and offer them positions on a new one....

But without an IRB at all, he can't do much of anything in terms of marketing the clinic/treatments. ...?

Interesting find! Wonder what the SEC filings would reveal…

Do I recall a 21st Floor post about that? I can't get the search to work there and I don't have it bookmarked.

Carigen, the Cayman Islands entity, incidentally, is wholly owned and controlled by Burzynski.

@flip

So if shutting down Burzyinski is also about going after the IRB, then the regulatory bodies need also to make sure he doesn’t just grab his 5 next closest buddies and offer them positions on a new one….

But without an IRB at all, he can’t do much of anything in terms of marketing the clinic/treatments. …?

He could try to set up another IRB under a different name, but he may have trouble with that. Might get more scrutiny due to past concerns about how he's operating.

But, yes, without an IRB, he would not be able to get his antineoplastons approved for marketing, which means he could not advertise it for the treatment of any disease or condition. Also, all use of it would have to be within the confines of a clinical trial.

So can we assume that the brave maverick has seen the writing on the wall for his particular brand of thievery and is preparing to bolt for countries more amenable to con-men and fraudsters?

I do hope he gets nailed before he flees.

So can we assume that the brave maverick has seen the writing on the wall for his particular brand of thievery and is preparing to bolt for countries more amenable to con-men and fraudsters?

Looks more like a Colonel Sanders–type of setup that they're after. The target countries (Bahrain, Dubai, South Korea, Indonesia, Malaysia, Qatar, Singapore, and Thailand) are something of a mixed bag.

Am I correct in guessing that Worldwide Medical Consultants, Inc -- the other entity mentioned in that licensing deal between Burzynski's various fronts -- is itself another Burzynski money-laundering front? It appears to have existed since 1998, without ever dealing with anything other than Burzynski Research Institute and the Carigen tax-avoidance entity.

By herr doktor bimler (not verified) on 30 Nov 2012 #permalink

Am I correct in guessing that Worldwide Medical Consultants, Inc — the other entity mentioned in that licensing deal between Burzynski’s various fronts — is itself another Burzynski money-laundering front?

This is difficult to say, given New Jersey's system of providing public records. What it's been doing for the past 14 years is certainly interesting. Still, if one entertains notions of Al Capone (I've really gotten the "bang bang" line in a taxi in Spain), I think one would really like to see how much revenue flux there is in a four-doctor clinic that seems to specialize in paternity testing.

But, yes, without an IRB, he would not be able to get his antineoplastons approved for marketing, which means he could not advertise it for the treatment of any disease or condition. Also, all use of it would have to be within the confines of a clinical trial.

Let's not forget how easy it was for the Geiers to pull this off with their own hand-picked IRB and no clinical trial registration. This went on for years and I don't recall their completely unethical IRB even being a point of charges against them. Although their malfeasance is so vast that I could be wrong on that.

By Science Mom (not verified) on 30 Nov 2012 #permalink

MarkL, why should I try to find the RESULTS?

herr doktor bimler, "bullsh1t?" Wow! I wonder how many people will now follow your lead & use profanity because "the doktor did it!" I am so glad you used the "1" in it so as not to offend as much. :-O

AdamG, you have not yet advised me what solar system you are living in. So, you think it's from 2012 but the link has 2011 in it. My research shows that that link was linked to another site as far back as 11/5/06, which as Narad pointed out, means that it likely applies to 1998-2003.

Todd W., No, "abracadabra" is Steve Miller's "magic word" when he sings "Abra Abra Cadabra, I want to reach out & grab ya."

flip, what's your point? You write that "[p]atients do not pay anything, before, during or after a clinical trial." Below are some sources which do not agree with you:
www.clinicaltrials.gov/ct2/info/understand?file=resources.html&amp%3bJS…

www.cancer.gov/clinicaltrials/learningabout/payingfor

http://health.usnews.com/health-conditions/cancer/information-on-clinic…
Narad, I am amazed at your mastery of the English language! "[A]sshurt," "sh*tty," & "f*cking!!" The "*" sign really differentiates you from petulant "yoots." However, I will not stoop to your level & ASSUME what your mental or emotional state is, because the "FACT" is that I do not know yours & you do not know mine, but I do know that you make an ASS out of U & ME when you ASSUME.

Peebs, nice try, but DJT refers to "Doubting Thomas."
I think we should call Peebs "Peeps." Do you "see" what I did there?

Denice Walter, you are so politically incorrect.

Narad, Dead Wood.

Chris, please point out where I stated that the PubMeds were "results" & cite which law or regulation requires the information you are requesting. Feel free to look up the contact for the Phase 3 clinical trial & e-mail or call them since you have so much time on your hands.

Science Mom, if you want to decide treatment based on a movie, that's fine with me! Venture Capitalists are great if you want to turn over some of your decision-making power to the people with the money. Just think, instead of wasting $60+ million trying to go after SRB the gub-ment could have given the $ to NIH to fund clinical trials! You did know that earlier this year it was reported that some NIH funded trials were not being published up to more than 2 1/2 years after completion, right?
www.sciencedaily.com/releases/2012/01/120103211056.htm
herr doktor bimler, read it as whatever you want to read it as, or you can go on the clinical trials site & look up the e-mail & phone # & use one of those resources to contact SRB & ask, or go on one of the SRB sites & look up the Public Relations/Media contact & contact them, or you can take the below video comments at face value that a new documentary is to be released re SRB in 2012, and watch it when it comes out to see if it answers your questions:
http://m.youtube.com/#/watch?v=jRua3NLg-Z8&desktop_uri=%2Fwatch%3Fv%3Dj…
Antaeus Feldspar, your absurd conclusion is that you would rather spend more time & energy re SRB who you have not provided any information as to how much he has been fined, rather than Big Pharma who has been fined $13 BILLION in the past 4 years. The difference is that Big Pharma has violated laws significantly more than SRB.

Science Mom, see above for your "shiny object!" ;-)

Lawrence, when Orac whined that SRB "got off on a technicallity," did you ask him to offer a "real retort" like SRB did not "get off on a technicallity," but he got off because the law is the law?

Todd W., yes, this is why the HHS filed 11 patents based on Antineoplastons.

M. Dawn, I am under no requirement to prove or not prove anything to you. I made what claim? As far as I'm concerned, based on your theory of thinking, your post is spam & trolling since it proves nothing.
Oh, and I should have added that I am under no requirement to show you anything.

A response to the father of a Burzynski patient - Respectful Insolence, SRB did not "slither away from justice again," but like Orac, he did have good legal advice.

JGC, please cite where I argued that you "should cese (sic) criticizing Burzynski's clinic and simply wait and see." Should we assign any blame to NIH which was running a clinical trial re Antineoplaston & didn't complete the trial but published the results of the incomplete trial?

Chris, why have you not apologized for misstating my argument?

Shay, from what I can tell, alot of this lot doesn't question the "FACTS."

Also, Chris, you have failed to say "Please."

Marc Stephens Is Insane, you're insane in the membrane because you have no verifiable "FACTS" that I did NOT read both articles.

Narad, you really are clueless, aren't you? How would I have been able to provide the links if I did not actually access the actual page(s) with the information I linked to? Here's a hint: you can search "Baldwin of Bewdley" on the internet like I did & see that this is the actual Title of a person. To me, "this one" is research

Marc Stephens Is Insane, did you access the link(s) & information & actually read what it's about? What's your motivation for not giving any indication that you've read the information available re the last 4 points of the post? What am I trying to prove that's unproveable? What was Orac's motivation for writing his comments on:
12/5/11 "[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy..." &
12/12/11 "Why do his supporters (and, let’s be honest, Dr. Burzynski himself) portray his therapy as “nontoxic” and “not chemotherapy..." &
1/20/12 "...contrary to Dr. Burzynski’s claim that he doesn’t use chemotherapy..."
though my post indicates this is not the case since at least the book 11/1/2006. If SRB indicates one thing in a book, something else in a movie, and something else elsewhere, then people should fact-check it. Maybe some people should post less & fact-check more.
My motivation is that if I am expected to believe that the information on this blog is "FACTUAL," then the people on this blog shouldn't take everything Orac posts as "FACT" without fact checking it. Orac should be held to the same standard he is holding SRB to. If Orac wants to be believable then he needs to be less vitrolic & more factual. I can not force anyone to believe anything if they are not open-minded enough to believe. No I do not work for SRB. I am not being paid to post comments. Those are rediculous questions unless you have asked Orac if he works for Big Pharma & is being paid by them to post comments.

AdamG, I didn't see you raise that issue on that blog, but I did. That's my point.

Marc Stephens Is Insane, if SRB is indeed making claims that are not backed up by "FACTS," then his feet need to be held to the fire like anyone else's.

Kreblozen, it would be interesting to find out what the final result are of the research re the trial that ended up in complete shambles.

Narad, they can't have it both ways. See my above previous reply to you re NIH. With all the fact-checking of people's posts it takes time for me to reply because some people are making comments that are questionable when it comes to their "FACTS." :-O

Lawrence: #1 - question the conflicting information. #2 - Why are you asking me? Find the law or regulation that requires it, contact their Public Relations/Media contacts like Orac has done, and post the results. Everyone on here should have the ability to find information on the internet.

JGC, I have not had time to address this since I'm too busy replying to everyone's posts.

Chris, see above reply to you. How many people have posed questions to you today compared to me? Thank you for your impatience.

flip, I can see you don't give a flip. Question conflicting information. It is the responsibility of the consumer to ask questions. That is the advice of the organizations I have posted links to today re cancer.

By Didymus Judas Thomas (not verified) on 30 Nov 2012 #permalink

Am I correct in guessing that Worldwide Medical Consultants, Inc

This other document --
http://www.sec.gov/Archives/edgar/data/724445/000110465912047927/a12-16…
-- inclines me to accept that Worldwide Medical Consultants, Inc are separate from Burzynski.

I have no idea whether the Delaware-incorporated Worldwide Medical Consultants is connected to the Florida-based Worldwide Medical Consultants that existed previously to 1998. There is some back-story.

Evidently WMC have convinced Burzynski that they can offer "substantial contacts, knowledge and experience in educating medical and health professionals and the public in the Covered Territories" (i.e. they know whose palms to grease), for the purpose of setting up the chain of Burzynski Clinics catering to the needs of a newly-affluent middle class. There is no doubt some reason why the deal calls for WMC to receive payments for their consultancy from the Cayman Island company and then pay %10 of that into Burzynski's home account.

By herr doktor bimler (not verified) on 30 Nov 2012 #permalink

And we can ask why there’s been so much research and patents issued re Antineoplastons:

It's an article of faith within the Burzynski support network that the US Gubblement has been using its dictatorial powers to deny the brave embattled researcher of his patents and of the recognition he deserves, so DJT has done everyone a favour by exposing this story as a load of cobblers.

By herr doktor bimler (not verified) on 30 Nov 2012 #permalink

And we can ask why there’s been so much research and patents issued re Antineoplastons penis and breast enlargement:

I strongly recommend the latest Oh No Ross and Carrie podcast on these subjects.

By Militant Agnostic (not verified) on 30 Nov 2012 #permalink

@Todd W

He could try to set up another IRB under a different name, but he may have trouble with that. Might get more scrutiny due to past concerns about how he’s operating.

But, yes, without an IRB, he would not be able to get his antineoplastons approved for marketing, which means he could not advertise it for the treatment of any disease or condition. Also, all use of it would have to be within the confines of a clinical trial.

@Science Mom

Let’s not forget how easy it was for the Geiers to pull this off with their own hand-picked IRB and no clinical trial registration. This went on for years and I don’t recall their completely unethical IRB even being a point of charges against them. Although their malfeasance is so vast that I could be wrong on that.

Thank you both. That helps clarify things for me, and put into context the problems of regulation.

Cookie please. Damn this is annoying...

By Marc Stephens … (not verified) on 01 Dec 2012 #permalink

Didymus Judas Thomas:

MarkL, why should I try to find the RESULTS?

Simple, you are making a claim, therefore you must provide the evidence. So if you wish to prove that Burzynski is not profited from desperate cancer patients with false hope, you must prove his methods work as well as another treatment that does, Gleevec.

Chris, please point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting. Feel free to look up the contact for the Phase 3 clinical trial & e-mail or call them since you have so much time on your hands.

Again, if you wish to show Burzynski is not a quack, you must prove it.

Shay, from what I can tell, alot of this lot doesn’t question the “FACTS.”

Also, Chris, you have failed to say “Please.”

Actually I did, to both.

Now you must either answer the questions that show Burzynski is legit, or apologize for wasting our time.

Chris, see above reply to you. How many people have posed questions to you today compared to me? Thank you for your impatienc

Unlike you, when I make a statement I already have the evidence at hand, which I provide for as I make the statement. And as of last night, I answered many questions. Mostly from my daughter on how best to make an outfit she is designing. I also answered why my laptop was acting weird (cookies not being recognized, being told security certificates were expired): after it crashed it reset its time and date to be 2083 and everything was 70 years out of date.

Now, be a good boy and stop whining, just answer our questions.

MSII, you should see how annoying it is when your computer flies to the future.

Ugh, curses. There was no preview and I missed closing a tag. Try again:

Chris, please point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting. Feel free to look up the contact for the Phase 3 clinical trial & e-mail or call them since you have so much time on your hands.

Again, if you wish to show Burzynski is not a quack, you must prove it.

Shay, from what I can tell, alot of this lot doesn’t question the “FACTS.”

Also, Chris, you have failed to say “Please.”

Actually I did, to both.

Now you must either answer the questions that show Burzynski is legit, or apologize for wasting our time.

Chris, see above reply to you. How many people have posed questions to you today compared to me? Thank you for your impatience

Unlike you, when I make a statement I already have the evidence at hand, which I provide for as I make the statement. And as of last night, I answered many questions. Mostly from my daughter on how best to make an outfit she is designing. I also answered why my laptop was acting weird (cookies not being recognized, being told security certificates were expired): after it crashed it reset its time and date to be 2083 and everything was 70 years out of date.

Now, be a good boy and stop whining, just answer our questions.

Shay, from what I can tell, a lot of this lot doesn't question the "FACTS"

Many of this lot are scientists, researchers and medical professionals, and hey're doing a fair job of shredding whatever you've managed to produce. You've demonstrated that you're doing a quick copy/paste without bothering to check the articles you're citing to see if they support your claims. I am not a researcher or medical professional, but even I can spot the "throw it at the wall and see if any of it sticks" tactics, just by actually, you know, READING a couple of your links.

But carry on. It's fun to watch.

No I do not work for SRB. I am not being paid to post comments. Those are rediculous questions unless you have asked Orac if he works for Big Pharma & is being paid by them to post comments.

Ahh, but Burzynski fans ask Orac and other science bloggers that very same question every single day. It's called the Pharma-shill gambit. I'm glad you are admitting it is "rediculous".

So why ARE you spending so much time defending Stan?

Do you defend other quacks like Simoncini, Gerson, John of God and Nick Gonzalez too?

By Marc Stephens … (not verified) on 01 Dec 2012 #permalink

Shay:

I am not a researcher or medical professional, but even I can spot the “throw it at the wall and see if any of it sticks” tactics, just by actually, you know, READING a couple of your links.

Also, the little whiny boy could not even be bothered to read the titles to his cut and pasta links! That has provided more than a few laughs.

@MSII - another Burzynski "patient" story on the same thread:

"I, too, have first-hand experience with Dr. Burzynski’s treatments. In 1996 my mom was diagnosed with two dominant cancers, ovarian and colon. She was given less than a year to live, I was her primary caretaker. My grandparents took my mom to Burzynski’s clinic in Houston after she decided to forego traditional medical treatments. Burzynski’s initially did no accept my mom as a patient but after my grandfather donated $1M dollars to Burzynski’s research program (Google Budwine & Burzynski and you’ll read about the donation and Burzynski introducing my grandfather to the president of Poland as a thank you) mom was quickly accepted into his program. She was hooked up to a 24/7 I.V. drip of the antineosplatons on her first visit as a patient. Lynn is right. The concoction is noxious. It wreaks of animal urine and the syrupy substance will eat through anything. Skin, fabric, wood. Mom lost her hair, her appetite, her memory, her personality, and she shed her skin and nails. Her skin blistered and the itching was enough to leave her begging for mercy in a cool bathtub every night. To honor her parents she persevered. After three months of treatment Burzynski declared her cancer free and mom died approximately one month later. Mom said taking the treatment was the worst decision she’s ever made. Buzynski lost all credibility with me for accepting her when he likely knew there was nothing he could do for her, treating her with such a toxic brew knowing how sick it would make her in vain, and for ever telling my mom she was cancer free. She was riddled with metastatic tumors when she died. In my humble opinion, it is a shame you have written this article without any first hand experience or reviews from patients or patient’s families. I respectfully request your update your article if possible with tales from both sides of the Buzynski story."

Funny how $1M changed Stans mind.

jergen, and that makes it all more despicable that a whiny little boy, Didymus Judas Thomas, spends so much time trying to defend Burzynski without providing any real evidence.

Didymus Judas Thomas:
"MarkL, why should I try to find the RESULTS?"

Eh? I am puzzled, you claimed that you were not asked for results. You were. Now your answer is "Why should I?".

Is that how you hope to "win" the debate ? By just being an obnoxious, intellectually and logically challenged halfwit?

You are out of your depth here by ANY reasonable measure, I advise you to get a responsible adult to make your decisions for you in future....... you know, like what to wear, what to eat for breakfast etc.

You are a buffoon.

Narad, I am amazed at your mastery of the English language! “[A]sshurt,” “sh*tty,” & “f*cking!!” The “*” sign really differentiates you from petulant “yoots.”

As I do not care to waste the time of our host with releasing comments from moderation for simple cursing, that's the way it goes, pillock.

However, I will not stoop to your level & ASSUME what your mental or emotional state is, because the “FACT” is that I do not know yours & you do not know mine, but I do know that you make an ASS out of U & ME when you ASSUME.

Thanks for the profound schoolmarmishness. There's nothing to assume. You plainly don't understand why what you're coughing up ranges from unimpressive to laughable.

Narad, you really are clueless, aren’t you? How would I have been able to provide the links if I did not actually access the actual page(s) with the information I linked to? Here’s a hint: you can search “Baldwin of Bewdley” on the internet like I did & see that this is the actual Title of a person.

I'm already able to recognize the style of a title in the peerage, you prat. As for accessing the "actual page(s)," no, I don't think you went and dug up an actual article from, say, Биомедицинская химия (moreover, there's a punchline if one does go after this one). Perhaps by "actual page(s)" you mean "PubMed entries." However, in this case, you would have noted, for example, that the entry from Lord Baldwin doesn't have any content there. It's a comment on an editorial. It is this, you imbecile. And this you cite in a linksplosion of "research" that is supposed to stun people who have already observed that you can't even make inferences about content from article titles with your towering mobile-device-based intellect?

To me, “this one” is research

Hammer & Jonas? Sure. But it's not the sort of research that has any bearing on the point that you thought you had made. The fact of the matter is that you were too goddamned stupid to figure out that you embarrassed yourself the first time and therefore tripled down with the same routine.

Puff Didy wrote:

flip, what’s your point? You write that “[p]atients do not pay anything, before, during or after a clinical trial.” Below are some sources which do not agree with you

Of the three links Didy then provides, one makes no reference at all to payments, one mentions the patient may be expected to pay for some incidental costs and routine lab work (but not the entire cost of the trial), and one link says this:

Will you have to pay to participate in a clinical trial?

The clinical trial sponsor (whether it is the U.S. government or a company) pays for the experimental treatment, and most pay for other parts of the treatment process, such as any special testing or extra doctor visits. Some sponsors pay for travel time or travel expenses. For Medicare patients, Medicare covers the costs of procedures that patients would have even if they were not in a clinical trial (routine costs) in all government-sponsored Phase II and Phase III clinical trials. Some health insurance companies also will cover routine costs in clinical trials. You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Therefore, be sure to ask questions about cost before making your decision to take part in a clinical trial, especially to confirm what costs your health insurance company will cover.

Once again Didy provides links that don't say what he thinks they say.

By Marc Stephens … (not verified) on 01 Dec 2012 #permalink

It’s a comment on an editorial.

I was amused by Earl Baldwin's turn of phrase in that comment, where he worries about "peer pressure".

By herr doktor bimler (not verified) on 01 Dec 2012 #permalink

yes, this is why the HHS filed 11 patents based on Antineoplastons

That reminds me:

Internet search of patent “0725635″ displays patent re Antineoplaston (Samid-GOVT OF USA as represented by the SCTY OF DEPT OF HHS), the 11 patents SRB contends the US issued to duplicate his patent.

I glazed over at this pidgin English the first time around, but that's not a U.S. patent number. One might wonder just how much puffery is involved in the "11 patents" routine that is trotted out but seemingly never documented. Do look those up for everyone's edification, DJT.

Antaeus Feldspar, your absurd conclusion is that you would rather spend more time & energy re SRB who you have not provided any information as to how much he has been fined, rather than Big Pharma who has been fined $13 BILLION in the past 4 years. The difference is that Big Pharma has violated laws significantly more than SRB.

Well, let's ignore for the time being the idiocy of your still pursuing the tu quoque "you can't say anything bad about my guru Stanwey until you've criticized everyone worse than he is." Let's also ignore the idiocy of thinking that fines are automatically proportional to wrongdoing and not being fined is therefore a sign of innocence.

Big Pharma is the term you're using to refer collectively to, let's see, how many multinational corporations? At least ten multinational corporations? And you're seriously suggesting that SRB can't come in for his fair share of criticism until he does more wrong (as measured by amount fined) than ten-plus multinational corporations?

Tell you what, Diddums: why don't you go out and find us any one individual who was fined $13 BILLION dollars? If you can't find one, you have two choices: you can either assert that obviously, no individual on earth can be criticized for wrongdoing because no individual matches the infamy of ten multinational corporations, or you can acknowledge what the rest of us already know, that trying to absolve one individual by comparing them to a plethora of multinational corporations is pretty damn stupid.

By Antaeus Feldspar (not verified) on 01 Dec 2012 #permalink

Chris, please point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting. Feel free to look up the contact for the Phase 3 clinical trial & e-mail or call them since you have so much time on your hands.

Nuh-uh Diddums; you made the claims, you provide the relevant citations instead of copypasta you found somewhere.

Science Mom, if you want to decide treatment based on a movie, that’s fine with me! Venture Capitalists are great if you want to turn over some of your decision-making power to the people with the money.

Dumb or dishonest? You're the one who trotted the movie out as some kind of proof. If Burzynski is so hard pressed for cash then he's got to turn over some autonomy. There are also other sources of venture capitalism that don't require that though. A little harder to come by and one has to have a solid proposal so I guess that leaves Burzynski out.

He's making money without approval; he has no intention of getting approval so enough with the boo-hoo poor Burzynski can't fund regulatory hurdles.

Just think, instead of wasting $60+ million trying to go after SRB the gub-ment could have given the $ to NIH to fund clinical trials!

Why should the NIH fund a molecular substance which holds no promise at all? You really don't know how this science stuff works do you.

You did know that earlier this year it was reported that some NIH funded trials were not being published up to more than 2 1/2 years after completion, right?
http://www.sciencedaily.com/releases/2012/01/120103211056.htm

More Tu Quoque nonsense from dumb didy dumb dumbs.

Science Mom, see above for your “shiny object!” ;-)

Not that you'd notice given how slow on the uptake you are but that isn't something you should be boasting about and calling attention to.

By Science Mom (not verified) on 01 Dec 2012 #permalink

DJT:
Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial?

Me:
Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial

DJT:
herr doktor bimler, read it as whatever you want to read it as, or you can go on the clinical trials site & look up the e-mail & phone # & use one of those resources to contact SRB & ask, or go on one of the SRB sites & look up the Public Relations/Media contact & contact them...

Dude, I am asking you for a clarification of your comment. How in the name of $DEITY is any advice from Burzynski going to help me understand what you meant when you cited the high cost of a Phase-III trial as a justification for not performing one?

By herr doktor bimler (not verified) on 01 Dec 2012 #permalink

I have no idea whether the Delaware-incorporated Worldwide Medical Consultants is connected to the Florida-based Worldwide Medical Consultants that existed previously to 1998.

Worldwide Medical Consultants, Inc., does not appear to be a Delaware corporation, the SEC form notwithstanding. The New Jersey one was NJ entity 0100732390, but that name has been revoked and they owe $1015.

DJT,

Kreblozen, it would be interesting to find out what the final result are of the research re the trial that ended up in complete shambles.

I can help you there. It (PMID:10069350) only accrued 9 patients because of disagreements between Burzynski and the NCI and only 9 were eligible for the study. Here's what Vickers had to say (PDF) about this study:

All six patients eligible for the study showed evidence of tumor progression after treatment durations of between 16 to 66 days. Neurologic side effects occurred in five patients. The mean time to treatment failure was 29 days. All nine patients died, eight of whom died due to tumor progression. Study authors concluded the study with the following statement: "The efficacy of antineoplastons A10 and AS2-1 remains uncertain. We were unable to document efficacy in any of six assessable patients."

By Krebiozen (not verified) on 01 Dec 2012 #permalink

I meant "only 6 were eligible..."

By Krebiozen (not verified) on 01 Dec 2012 #permalink

@Didymus

flip, I can see you don’t give a flip. Question conflicting information. It is the responsibility of the consumer to ask questions. That is the advice of the organizations I have posted links to today re cancer.

And I can see you like sentences that are too all over the place to make any sense, Gish gallop and preference for assertions over evidence. Oh, and that sentence above also suggests you enjoy strawmen.

Here's what I said to you last:

Well sure, because books and patents are exactly the same as results from double blind placebo trials in a peer-reviewed journal. *rolls eyes

If you missed my point, let me spell it out for you. Anyone can get a patent on anything. You don't need to actually make something in order to get a patent. In fact, many items haven't been made. Getting a patent only means you had the time, energy and money to fill out a form.

Books aren't peer-reviewed. Here's why they are useless as evidence.

Feel free to question conflicting information. But you might want to try raising your standards a little as to what you accept as information. For example, plenty of books and patents exist on blood letting. It doesn't mean that that old pre-scientific technique worked though. (Most of the patents I saw on the US Patent website were for legitimate blood letting stuff - from what I could tell, things like blood collection, etc. Still my point holds true)

But why do I waste my breath? It's clear you don't care about that stuff, you just want us to pat you on the head and say "you're right". Shifting the goal posts (float like a butterfly, sting like a bee seems to be an apt way of describing your antics) and making distracting arguments is nice and all, but you still haven't provided us with any reason why we should accept Burzyinski's methods work: since he hasn't even done that himself.

Also, see Marc's reply to you about the clinical trial payments. The links you supply suggest, at best, that a patient may have to pay some side costs - ie. what you'd pay to see a doctor as part of your illness anyway - but none state that you have to pay for the research costs themselves. In other words, you wouldn't normally be paying $300k or more for participation. The others are right, you're not reading what you're posting links to.

@Science Mom

He’s making money without approval; he has no intention of getting approval so enough with the boo-hoo poor Burzynski can’t fund regulatory hurdles.

More to the point, if he can afford a multi-million dollar home, he can afford to put it up for sale to pay for a proper trial.

flip, let's not exaggerate (or post without understanding):

If you missed my point, let me spell it out for you. Anyone can get a patent on anything. You don’t need to actually make something in order to get a patent. In fact, many items haven’t been made. Getting a patent only means you had the time, energy and money to fill out a form.

2nd sentence - semi-true. 3rd sentence - true. 4th sentence - true. 5th sentence - very untrue.

I don't feel the need to clarify. It's obvious (for those of us who have patented stuff).
Btw, I don't feel most of you are able to carry a civilized and respectful discussion without personally insulting your opposition, so please don't try to involve me in anything. Just couldn't resist this time after seeing over and over how people try to make their points by using fake arguments..

float like a butterfly, sting like a bee seems to be an apt way of describing your antics

Please, let's not sully Ali here. DJT is more along the lines of Reggie Strickland.

Just think, instead of wasting $60+ million trying to go after SRB the gub-ment could have given the $ to NIH to fund clinical trials!

$60 million? Whose ass did you pull that number out of?

By W. Kevin Vicklund (not verified) on 01 Dec 2012 #permalink

@Narad

Oh, that a-hole - didn't he show up in the comments here a while ago?

I think "float like bee, sting like a butterfly" for doesn't know diddly.

By Militant Agnostic (not verified) on 01 Dec 2012 #permalink

@Narad

Please, let’s not sully Ali here. DJT is more along the lines of Reggie Strickland.

Forgive me, sports is not in my vein of interest. It was the first thing that popped into my mind. DJT's writing style has a feel of hopping from one foot to another trying not to get caught.

Very confused as to what exactly DJT is trying to prove, since everything he's posted has been proven incorrect....

Get ready Burzynski “FANS!!!”
Burzynski: Cancer Is Serious Business Part II
Coming Early 2013 (Trailer time: 5:09)
http://www.burzynskimovie.com/index.php?option=com_content&view=article…
Statement by David Kessler, FDA Commissioner, The White House, C-SPAN, re Antineoplastons.
Statements from SRB, individuals, medical professionals,
FOX 26 News, Dr. Masakazu Sawanobori, Tokyo, Japan.
http://www.biomedexperts.com/Profile.bme/1249742/Masakazu_Sawanobori
Book by Sawanobori including information about him:
http://en.d21.co.jp/books/vitamin-c-as-effective-cancer-treatment

By Didymus Judas Thomas (not verified) on 02 Dec 2012 #permalink

Thats it DJT?

Your position of last resort is to just to be a blatant troll? I knew you were thick, but I hadn't guessed quite how thick!

@DJT - so if Dr. B ready to reveal the results of his 30 years of "clinical trials?"

Ah, I see now. DJT is just a promoter for a new 'movie'.

Nice to see that he's really not interested in answering my questions.

Shouldn't the new movie be Cancer is a Lucrative Business? It certainly is for Burzynski and his henchmen.

By Militant Agnostic (not verified) on 02 Dec 2012 #permalink

Book by Sawanobori including information about him

So, now you're down to appealing to the authority of a Japanese proponent of intravenous vitamin C quackery? Well done.

Marc Stephens Is Insane, please provide FACTUAL proof to prop up your deluded statement that "I guess Didy didn’t bother to read those information sheets either."

Chris, what claim am I making? Please cite the claim & date of the post. Why do you mistakenly think it's my responsibility to "show Burzynski is not a quack?" Please cite where I have indicated that SRB is or isn't a quack & the date of the post. Why do you mistakenly believe it's my responsibility to "show Burzynski is legit?" Please cite where I have indicated that SRB is or isn't legit & the date of the post. Why should I apologize when you have not apologized for misstating my argument 11/28 as pointed out in my 11/28, 11/29 & 12/1/12 posts? I asked you "[h]ow MANY people have posed questions to you" & you were not able to provide a # but just "MANY." (Emphasis added for ease of reading.) Actually, are you having trouble with numbers, especially the concept of the “one?" One, as in a number between zero & infinity. Now, stop whining, just answer my questions. In my 12/1 post I asked you to "[P]lease point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting," & you did not, though you posted my question to you; one right after the other, in 2 of your 12/1/12 posts.

Narad, good question. Who are you?

Shay, please cite any post(s) & their dates which "shredded whatever" I've "managed to produce" where I have not responded to their alleged "FACTS." Please cite any post(s) & their dates which support your allegation that I've "demonstrated that" I'm "doing a quick copy/paste without bothering to check the articles" I'm "citing to see if they support" my "claims." Maybe you'd like to take a crack at my above post to Chris where I point out that my question has still not been answered, just by actually, you know, READING."

Marc Stephens Is Insane. please cite any post(s) & their date which support your misguided allegation that I am "spending so much time defending Stan." And No, I am not defending quacks.

Chris, please cite any post(s) & their date which support your misguided attempt at trying to prove that I "could not even be bothered to read the titles to" my "cut and pasta links!" Exactly what are "PASTA links?" :-|

jergen, another Burzynski "patient" story:
www.salem-news.com/articles/february222011/burzynski-cancer-kt.php

www.salem-news.com/articles/june072011/laura-jo-hofsess-.php
Chris, and that makes it all more despicable that you misguidedly claim that I spend "so much time trying to defend Burzynski without providing any real evidence."

MarkL, please cite any post(s) & their dates that buttress your misguided belief that I "claimed that" I was "not asked for results." At least I am an Adult who does not need to stoop down to your level of adolescent name-calling.

Narad, how old are you? 9? Because that's what your choice of coarse language suggests. And if you are "already able to recognize the style of a title in the peerage," why did you write on 11/30/12 that "Baldwin of Bewdley” as author should really be a flag," but not state why it should be a flag? Way to ASSUME that i somehow attempted anything "that is supposed to stun people." Since you obviously have the miraculous power to read my mind, what is the "point that" I" thought "I" had made"?

Marc Stephens Is Insane, you quote my post:
"flip, what’s your point? You write that:
“[p]atients do not pay anything, before, during or after a clinical trial.”
Below are some sources which do not agree with you."
1. You write that: "one makes no reference at all to payments," yet the 1st link states: Questions to Ask: Anyone interested in participating in a clinical study should ... feel comfortable asking the research team questions about ... any expenses.
2. The 2nd link: Paying for Clinical Trials: As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. Even if you have health insurance, your plan may not cover all costs related to receiving treatment in a clinical trial. There are 2 types of costs associated with a clinical trial: patient care costs & research costs. Patient care costs are those costs related to treating your cancer. These costs are often covered by health insurance. They include: Doctor visits,
Hospital stays, Lab tests, X-rays & other imaging tests. Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include: The study drug, Lab tests performed purely for research purposes, Additional x-rays & imaging tests performed solely for the trial. When you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. These extra visits can add costs for transportation & child care.
3. The 3rd link:"Who is responsible for the costs of the clinical trial (tests, doctor's visits, etc.). Who is responsible for the costs if a patient needs additional care as a result of the clinical trial. The trial sponsor may pay for some of your medical care or tests. Be sure to ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate. Your medical care may be more expensive. Your health insurance company may not pay for your clinical trial care or tests. Be sure to ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate. Where you live may require more money for travel. You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Be sure to ask questions about cost before making your decision to take part in a clinical trial, especially to confirm what costs your health insurance company will cover. Would I be responsible for additional costs of tests or travel?
Once again Marc Stephens Is Insane misrepresents links that don’t say what he thinks they say.

By Didymus Judas Thomas (not verified) on 02 Dec 2012 #permalink

Narad, how old are you? 9? Because that’s what your choice of coarse language suggests.

When was the last time that a nine-year-old called you a prat, Fanny? Have some salad creme and relax.

And if you are “already able to recognize the style of a title in the peerage,” why did you write on 11/30/12 that “Baldwin of Bewdley” as author should really be a flag,” but not state why it should be a flag?

Well, I was mocking you on the grounds of general ignorance, so I don't know that I'm really responsible for providing an exercise key.

Way to ASSUME that i somehow attempted anything “that is supposed to stun people.”

Oh, look, it's the magic teaching puzzle again.

Since you obviously have the miraculous power to read my mind, what is the “point that” I” thought “I” had made”?

Precisely that which you stated at the outset of your humiliating and comically inept self-immolation: that these offererings represented support for the assertion that "there’s been so much research."

Didymus Judas Thomas, you are pathetic. As a acolyte of Burzynski you are adept at using the Gish Gallop, but completely unable to find one paper that shows his methods are as effective as Gleevec for the treatment of any cancer. It is truly sad that you spend so much time defending a fraud without any evidence.

I think enough is enough .

Diddums clearly has no intention of answering any of the questions put to him, and is more intent on frustrating the debate than in joining it.

Time to move on, remembering this sage advice:

"Please do not feed the Troll"

@DJT

Do you understand the meaning of the word 'prove' or 'evidence'? You're like those people who insist it's up to everyone else to disprove god.

Your word salad Gish gallop is almost incomprehensible. Can you perhaps slow down and take small bites?

The rest of your comment about who pays for what in a trial either shows you can't/won't read, or you have trouble understanding English. Is it not your native language?

In none of the above have you even come close to proving that Burzyinski has published evidence, that you have provided it, or that we should stop asking for it for any reason.

@flip - I was going to say incomprehensible, because I have no idea what he's trying to say...

The reason why Earl Baldwin of Bewdley is a red flag when discussing alternative medicine is that the same reason Kent Hovind would be a red flag if we were discussing evolution: Baldwin is a known and prominent promoter of woo, who as a member of House of Lords Science and Technology Sub-Group for Alternative and Complementary Medicine wrote a report in support of homeopathy.

I think he's trying to say that he's neutral, and that we should supply proof that he isn't. Or something. 'Almost' incomprehensible is probably an understatement.

I'm willing to believe that perhaps he's just misunderstanding what he's reading, due to language barriers. (There's a huge difference to his style as compared to Marg or Judtih)

Narad, www . radaris . com/p/Dvorit/Samid

Antaeus Feldspar, if you don't watch out you'll have a brain aneurysm trying to prove that False Positive! :-o
Please cite the post(s) & their date which you misguidededly think exists, proving that my guru is Stanwey. I'm seriously suggesting that you & others are expending more energy on SRB than on executives from GlaxoSmithKline; which was fined the biggest drug co fine to date of $3 BILLION, yet no executives were fined.
“What we’re learning is that money doesn’t deter corporate malfeasance,” said Eliot Spitzer, who, as New York’s attorney general, sued GlaxoSmithKline in 2004 over similar accusations. “The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.”
Others have said that to institute real change, executives must be prosecuted criminally or barred from participating in the Medicare & Medicaid programs, an action known as “exclusion.”
This has occurred in only a handful of cases, and rarely in a case involving a major pharmaceutical company. In 2011, 4 executives were sentenced to less than a year in prison for conducting clinical trials that were not authorized by the FDA.
That same year, the former chief executive of a drug co was sentenced to 30 days in jail & fined $1 million for selling misbranded drugs.The previous year, HHS excluded him from doing business with the federal government.
www . nytimes . com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all
Yet Glaxo earned $27.9 BILLION on 3 drugs during the time-period covered.
New York Attorney General Eliot Spitzer sued GSK in 2004; which earned $3 BILLION in 2003 on the drug in question, alleging they misled doctors by concealing it's adverse effects & released only 1 out of at least 5 studies on the drug:
www . ecommercetimes . com/story/36159.html
That an internal memo said that in light of the poor study results, the company's "target" was to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact". It says that the company also gave its salespeople a memo stating that the drug "demonstrates remarkable efficacy and safety..." Attached to the memo, the suit says, was the 1 published study that showed some positive results:
www . nature . com/drugdisc/news/articles/429589a.html
Estimated that the drug was prescribed to 2.1 million people & earned $55 million that year:
www . ag . ny . gov/sites/default/files/pdfs/bureaus/health_care/newsletters/hcnews_junjul04.pdf.
"Because so much drug company data submitted is considered proprietary, it is up to the F.D.A. to decide when to disclose possible safety concerns."
www . nytimes . com/2004/06/03/business/spitzer-sues-a-drug-maker-saying-it-hid-negative-data.html?pagewanted=all&src=pm
Former New York Governor Eliot Spitzer, who’d sued GlaxoSmithKline previously while serving as New York’s attorney general - argued that seeking monetary damages isn’t going to change most problematic practices of the pharmaceutical industry. Instead, they say, we should seek criminal charges against specific executives, the risk of jail time being the only way to actually change behavior. In the last 3 decades, the FDA has become increasingly dependent for its continued functioning upon user fees paid by the very drug makers it’s meant to regulate.
www . ideas . time . com/2012/07/06/glaxo-fine-what-will-stop-big-pharma-fraud

By Didymus Judas Thomas (not verified) on 03 Dec 2012 #permalink

Science Mom, so you still refuse to cite which post(s) & their date applies to this "claim" you keep referring to but for some reason can't cite. See my above post re Part II of the Burzynski movie.
Maybe NIH should fund it because of this:
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
Authors: Burzynski SR, Janicki TJ, Weaver RA, Burzynski B.
Journal Integr Cancer Ther. 2006 Mar;5(1):40-7.
Affiliation: Department of Internal Medicine, Burzynski Clinic, Houston, Texas 77055, USA. srb@burzynskiclinic.com
Abstract: BACKGROUND: Brainstem glioma carries the worst prognosis of all malignancies of the brain. Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years. Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG). The objective of this report is to summarize the outcome of patients with HBSG treated with antineoplastons in 4 phase 2 trials. Patients: The following group of 18 patients was evaluable: 4 patients with glioblastomas and 14 patients with anaplastic HBSG. Fourteen patients had diffuse intrinsic tumors. Twelve patients suffered from recurrence, and 6 patients did not have radiation therapy or chemotherapy.
METHODS: Antineoplastons, which consist of antineoplaston A10 (A10I) and AS2-1 injections, were given in escalating doses by intravenous injections. The median duration of antineoplaston administration was 5 months, and the average dosage of A10I was 9.22 g/kg/d and of AS2-1 was 0.31 g/kg/d. Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography.
RESULTS: The overall survival at 2 and 5 years was 39% and 22%, respectively, and maximum survival was more than 17 years for a patient with anaplastic astrocytoma and more than 5 years for a patient with glioblastoma. Progression-free survival at 6 months was 39%. Complete response was achieved in 11%, partial response in 11%, stable disease in 39%, and progressive disease in 39% of patients. Antineoplastons were tolerated very well with 1 case of grade 4 toxicity (reversible anemia).
CONCLUSION: Antineoplastons contributed to more than a 5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients.
PMID 16484713 [PubMed - indexed for MEDLINE]
Full text: HighWire Press. Related Citations (304)
www . ncbi . nlm . nih . gov/m/pubmed/16484713
Y'all are the ones whining about reports not being published, yet you cite no law or regulation that requires the publishing.
http: // highwire . stanford . edu/cgi/searchresults?RESULTFORMAT=1&hits=150&sortspec=match&sendit=Update+display&tyear=2013&resourcetype=1&tmonth=Dec&fulltext=Antineoplastons&andorexacttitleabs=and&src=ml&author1=Burzynski&fmonth=Jan&y=0&fyear=1753&x=0&fdatedef=1+January+1753&andorexacttitle=and&searchsubmit=redo&andorexactfulltext=and&tdatedef=3+Dec+2012
herr doktor bimler, refer to my above post re Part II of the Burzynski movie.
Dude, only SRB knows if he has the $.

flip, you "talk" a lot but I guess you don't know how to do a search on the Internet, but then again, it was the strawman in the Wizard of Oz that didn't have a brain.
I'm not the one who made the over-broad generalization that: “Patients do not pay anything, before, during or after a clinical trial.” That was flippant.

Narad, and I guess you're more along the lines of George Bush ... pick 1.

By Didymus Judas Thomas (not verified) on 03 Dec 2012 #permalink

W. Kevin Vicklund, look behind you.
www . thenhf . com/article.php?id=3326

www . healthlifee . com/disease/cancer/12754-the-many-trials-of-dr-burzynski.html

https: // docs.google.com/viewer?a=v&q=cache:ElTW2l484TUJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Li…

https: // docs.google.com/viewer?a=v&q=cache:Q5CJZ7wMlm8J:dash.harvard.edu/bitstream/handle/1/9453691/mstennes.pdf%3Fsequence%3D1+&hl=en&gl=us&pid=bl&srcid=ADGEESgpwuCsrSXG4QtI80dh0bj5gapqSiOCt--5MZHN1yPkemicxoBErvoU4OS9_rjKlHo7KR7afzi_YKNmo-0nyWUR7kOYuv8nNR7jy1s3MKTlBdeDCxBqURMWNOCvcB2JxOlowbaG&sig=AHIEtbQ-32lniQlIAduG2ZMSTX1gbT-Qgg

https: // docs.google.com/viewer?a=v&q=cache:gU3fCI4uOhoJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Li…

Lawrence, please enlighten me on how my 2 11/28 posts
were proven incorrect, for example.

MarkL, let me guess, you suffer from insecurity? You perhaps posit that people are not interested in the Trailer or anything else which might answer some of the questions they have posted on this blog.

Lawrence, did you view the trailer?

flip, I think we know who's getting more questions from other posters on here, and it's not you!

Narad, I haven't been to Limey Blimey Pea Soup Country. Have some tater salad & relax. And I am mocking you on the grounds of feigned ignorance. You should learn how to use that "matching teaching puzzle." Have you ever solved a Rubix Cube? Research like those in the above last link to Science Mom?

Chris, you are more pathetic because of your "stick-my-head-in-the-sand" ostrich-like standing that you are so physically & mentally inept that you keep positing theory along the lines that ignorance of the law is an excuse.

By Didymus Judas Thomas (not verified) on 03 Dec 2012 #permalink

Have you ever solved a Rubix Cube?

Yes, and I can even spell it correctly. It's trivial if one can remember so much as two transformations in the group.

CONCLUSION: Antineoplastons contributed to more than a 5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients.

Um, one cannot legitimately arrive at this conclusion, given the "design." Did you get this from Moss again? Do you understand why ICT is not exactly an impressive source?

DJT,

You still don't understand what the tu quoque fallacy is, or what a controlled clinical trial is, apparently. You swamp this blog with references to articles about Burzynski, none of which are good evidence of anything, and then claim you are not supporting him. What was the point of posting all those links? If you are trying to destroy any small amount of remaining credibility you have left, don't bother, you lost it all some time ago.

By the way, many of Burzynski's longest surviving patients had conventional treatment. You linked to a story about Laura Jo Hofsess who had Tarceva, Herceptin and radiotherapy as well as antineoplastons. As MSII mentioned, sadly she didn't survive. We don't know what contribution to survival any of Burzynski's treatments have made because he has never published (or carried out as far as I can see) any controlled studies.

By Krebiozen (not verified) on 03 Dec 2012 #permalink

DJT is a true blue Burzynski fanboy who has graduated into a full troll. Time to ignore him.

Science Mom, so you still refuse to cite which post(s) & their date applies to this “claim” you keep referring to but for some reason can’t cite. See my above post re Part II of the Burzynski movie.

Sorry, can't keep track of your incoherent word salads. Don't know what I'm refusing to do.

Maybe NIH should fund it because of this:
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
Authors: Burzynski SR, Janicki TJ, Weaver RA, Burzynski B.
Journal Integr Cancer Ther. 2006 Mar;5(1):40-7.

Bwahahaha!!! Sure the NIH is going to fund crap based upon personal testimonies. It's bad enough they fund homeopathy Tell your mate Burzynski to apply for an NCCAM grant, he'd have better luck since they fund quackery. Or ya know, he could actually publish the results of his decades-long "clinical trials".

By Science Mom (not verified) on 03 Dec 2012 #permalink

Insecurity?

Not at all Diddums, I just think it pointless to argue with a Burzynski fanboy who ignores any request for even the smallest sliver of evidence that the object of his perverse support is anything other than a con man, yet continues to post advertorials and puff pieces from dubious sources as "proof" that the maverick doctor deserves other than ridicule and condemnation.

Everything you have posted in this thread adds up to a big fat zero, you have achieved nothing other than to make yourself look ridiculous.

W. Kevin Vicklund, look behind you.

Falsely claiming that I was the person who claimed that Burzynski cost taxpayers $60 million in lawsuit(s) is not getting off to a good start. Or are you admitting to assault?

www . thenhf . com/article.php?id=3326

Written in 2012, no source other than Burzynski, author not involved in the trial in any capacity. Not a reliable source.

www . healthlifee . com/disease/cancer/12754-the-many-trials-of-dr-burzynski.html

Written in 2010, no source other than "documentary" paid for by Burzynski, author not involved in the trial in any capacity. Not a reliable source.

https: // docs.google.com/viewer?a=v&q=cache:ElTW2l484TUJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Li…

https: // docs.google.com/viewer?a=v&q=cache:Q5CJZ7wMlm8J:dash.harvard.edu/bitstream/handle/1/9453691/mstennes.pdf%3Fsequence%3D1+&hl=en&gl=us&pid=bl&srcid=ADGEESgpwuCsrSXG4QtI80dh0bj5gapqSiOCt–5MZHN1yPkemicxoBErvoU4OS9_rjKlHo7KR7afzi_YKNmo-0nyWUR7kOYuv8nNR7jy1s3MKTlBdeDCxBqURMWNOCvcB2JxOlowbaG&sig=AHIEtbQ-32lniQlIAduG2ZMSTX1gbT-Qgg

https: // docs.google.com/viewer?a=v&q=cache:gU3fCI4uOhoJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Li…

Proof that you are serving up plenty of copy-pasta rather than something you read: none of these three sources make a claim that the trial(s) cost taxpayers $60 million. Also, these documents are available direct, without having to resort to a Google docs archive.

Care to try again? Whose ass are you reaching into?

By W. Kevin Vicklund (not verified) on 03 Dec 2012 #permalink

I love the sources Didy provided written by Dr. Julian Whittaker, a very special kind of quack who has been discussed here by Orac (and debated with Orac!) in depth.

A master of the graph.

He's in Burzynski's back pocket because of that anti-aging project they've been working on and he is the only doctor who will speak out in support of Burzynski (not counting the two anonymous doctors in the new movie trailer). What else do you expect? They're partners.

By the way, I strongly suspect the Asian Burzunski clinics he's looking to open will heavily promote the anti-aging angle of his business. Just a hunch.

And he's also a scientology doctor who endorses their lethal Narconon program.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

Hey guys and gals, sometime I just love that you are able to quote relevant quotes from Didysquat's post because I have a really, really hard time reading his post.

@ Didysquat, would you please ventilate your post, I understand absolutely nothing of what you write.

Alain

Sorry, I put an extra "t" in Whitaker's name.

Here's part of his entry on Wikipedia (I know, I know, but the sources are good...):

Whitaker opposes the use of pharmaceuticals in the treatment of mental illness and believes that psychiatry is fraudulent. In a CNN interview with Anderson Cooper, Whitaker states that psychiatric diagnoses have "no basis" and are fabricated or voted into existence by powerful groups of doctors with financial interests. The combination of medication and talk therapy endorsed by psychiatry is a "script", says Whitaker, who claims in the interview that his golden retriever can provide talk therapy just as well as a psychiatrist. According to Whitaker, vitamins, such as those promoted on his website, can cure psychiatric disorders by improving general health.

Criticism

Whitaker has been a controversial figure, and has been criticized for his self-promotional approach to medicine, potential conflicts of interest, and his embrace of scientifically unsound practices.

The National Council Against Health Fraud (NCAHF) criticises Whitaker for promoting himself as "America's #1 health advocate," "America's #1 health champion," and "the physician America trusts." According to the NCAHF, Whitaker advocates potentially dangerous therapies involving growth hormones, chelation and megavitamins, and intervenes on behalf of other "maverick" doctors in legal trouble.

The Los Angeles Times notes that Whitaker serves as a consultant to vitamin companies advertised on his website, a practice criticised by other doctors who prefer to promote only evidence-based products. In the article, Whitaker is classified as a doctor "mixing celebrity and cyberspace".

Whitaker claims to be a leading expert in "anti-aging medicine.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

I have a really, really hard time reading his post.

You're not the only one. DJT seems to really not grasp the concept of "context." It's like the whole thing has to be reconstructed from scratch, including what's taken from elsewehere with no indication, with every word-blob.

Furthermore, does he think we're not aware of all the puff pieces, vanity articles, insignificant studies published in non-credible journals, etc.? Or support editorials by other quacks? Several of those pieces have provided fodder for Orac and other science bloggers in recent times, to be explained, debunked or ridiculed.

I'm suprised he hasn't posted the Dr. Oz/Eric Merola TV interview yet.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

@ Marc Stephens Is Insane:

Whitaker, like Gary Null, claims special knowledge in the arcane 'science' of anti-aging medicine which includes such as ideas as:
you live much longer if you severely restrict calories**,
guzzle gallons of green juices.
take handfuls of supplements,
limit sugar,
eat mostly raw for 'enzymes', cook at 116 degrees F or less,
use organic and unprocessed foods, sans additives,
avoid acidic foods ( Young),
exercise every day and maintain an extremely low weight and BMI.
They also scoff about environmental pollution, radiation*** and EMFand about a THOUSAND OTHER THINGS.
I think you get the general idea that they believe that aging comes from external sources; damaged DNA can be repaired with the right nutrition etc.
I guess there's nothing natural about aging- at least in their fevered imaginations.

** works in rats, so why not in woo-meisters?
*** but not the sun.

By Denice Walter (not verified) on 03 Dec 2012 #permalink

Denice,

Whitaker is "board certified" in anti-aging, except there's no such thing.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

From a Houston Times story on Burzynski back in 2008. I posted this on the other Burzynski thread a few days ago:

Which leads to one of the most troubling aspects of the Burzynski saga: Why have no credible oncologists stood up for him? Why don’t oncologists regularly refer their patients to his clinic? Why aren’t the greatest minds in medicine calling for the swift approval of antineoplastons?

If they are out there, the Press needs to hear from them. Burzynski obliges as best he can, throwing out the name of perhaps his biggest ally in medicine (using that term loosely). That is Julian Whitaker, an alternative medicine practitioner who claims to be “board-certified in antiaging medicine.” That could be true — it’s just a question of which board he’s talking about. One thing is for sure: It’s not the American Board of Medical Specialties, which is what most doctors are talking about when they say “board-certified.” The ABMS does not recognize “anti-aging” as a medical specialty. When asked for the names of supporting doctors who don’t have Web sites featuring “Rollback Savings!” on their lines of nutritional supplements, Burzynski eventually comes up with Bruce Cohen, a brain tumor specialist at the Cleveland Clinic. Cohen did not return calls.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

By the way, someone named "Leah" posted a comment triumphing the Burzynski dismissal and championing other brave mavericks like Budwig. The comment seems to have been lost in the shuffle as there are no replies, and it's a few comments up from the end, so I thought I'd bring it to your attention in case anyone feels like doling out some respectful insolence.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

Darn, I really am losing my mind in my old age. The "Leah" comment is on the "response to a Burzynski father" thread. It looks to be copy-pasted from some Stan fan site. It's really quite amusing.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

@DJT

I will only bother in reposting what Krebiozen said:

DJT,

You still don’t understand what the tu quoque fallacy is, or what a controlled clinical trial is, apparently. You swamp this blog with references to articles about Burzynski, none of which are good evidence of anything, and then claim you are not supporting him. What was the point of posting all those links? If you are trying to destroy any small amount of remaining credibility you have left, don’t bother, you lost it all some time ago.

and Science Mom and I are in agreement:

Sorry, can’t keep track of your incoherent word salads.

I have no idea what you were trying to say to me.

@Marc Stephens is Insane,
I was amused that "Leah" prominently mentioned Wilhelm Reich, a very good candidate for the most notorious crazy crank of the twentieth century. Still, it's hard to deny that Reich's story still gives a certain charm, which I find completely lacking in Dr. B.

Incidentally, people posting links for Dr. B could be affecting search results, which admins should consider. Ironically, it could have the effect of boosting rankings for sites of his critics. I will admit to dabbling in that sort of thing, just to counteract keyword-loaded garbage a stalker put up on a site where terms of use are only enforced on behalf of people who can afford lawyers.

David N. Brown
Mesa, Arizona
www.exotroopers.wordpress.com
www.evilpossum.weebly.com

By David N. Brown (not verified) on 03 Dec 2012 #permalink

It seems her entire post, lock stock and barrel was lifted right off a Burzynski site, or Facebook posting.

I have to agree wholeheartedly with Leah's post. Burzynski definitely belongs in the same category as Gerson, Rife, Hoxsey and Budwig. Just not the way she means.

Leah's post actually made me aware of some other quacks I'd never heard of, and have been merrily Googling them too. Some serious fruitcakes and nutbars in that list. I love the people who believe shining coloured lights on different parts of your body can heal.

From Leah's post:

The bottom line is this; if it’s owned or patented by a private individual, or can’t be patented at all, and can be used to cure cancer especially, you are not going to be allowed to practice your craft or use the technique or substance as a treatment and especially call it a “cure,” as long as the medical establishment can help it, thus far at all costs.

But it seems as if the medical establishment has so far been unable to stop Burzynski from "practicing his craft" so the entire paragraph is meaningless.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

And I had no idea it was Reich behind the whole orgone thing. I thought that was more modern nuttery, from the whale.to era, like chemtrails.

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

I came across this earlier tonight: the blog of another Burzynski patient who died this past summer, six-year-old Supatra Adler. There's a chart of all the treatments the parents were forcing this little girl to undergo beside the antineoplastons. They had her on Thai herbal medicine, mushroom extract from Taiwan, grapeseed extract, algae (to "detox" from radiation), several large glasses of juice a day (Gerson?), AND a Budwig diet. They complain that the little girl didn't take to the cottage cheese and flax seed: what six-year-old eats that?

Take a look at this chart:

http://supatrascancerfight.blogspot.ca/p/treatments.html

By Marc Stephens … (not verified) on 03 Dec 2012 #permalink

@Marc Stephens Is Insane,
Reich and orgone are well-covered by historians of science. To my recollection, one of the first places I read about him would have been the "Big Book of" comic/ encyclopedia series. He was also covered in Martin Gardner's "Fads and Fallacies". As I indicated, many accounts almost put him in a sympathetic light. I think it's especially telling that for better or worse, Reich really did live up to the image of the independent, non-conformist "maverick". With Burzynski, on the other hand, it looks increasingly like he doesn't (and maybe CAN'T) do much of anything without the approval of his lawyers and PR men. It's as if big business has strip mined the romance even out of the crazies and charlatans.

David N. Brown
Mesa, Arizona

By David N. Brown (not verified) on 03 Dec 2012 #permalink

Reich undoubtedly started off sane, as a student of Freud with some valuable (IMHO) ideas about sexual repression, and undoubtedly ended up totally bonkers, believing he could zap invading alien spaceships with his cloudbusters. It's hard to say just where in his career he completely lost the plot. There are some interesting parallels between Reich and Rife BTW, both believing they had discovered a cancer bacillus, for example. Reich is yet another example of an expert wandering out of his area of expertise and into trouble.

By Krebiozen (not verified) on 04 Dec 2012 #permalink

flip, I knew in your rigorous search for the truth that you would want to know any new information on SRB that comes to light. :-)

Militant Agnostic,
$1.58 BILLION: Drug co's & healthcare marketeers projected to spend on online advertising in 2012:
www . pharmalot . com/2012/06/pharma-will-spend-how-much-advertising-online
19 times more: Amount drug co's spend on self-promotion compared to basic research.
$200 BILLION: Amount drug co revenues rose between 1995-2010
www . huffingtonpost . com/mobileweb/2012/08/09/pharmaceutical-companies-marketing_n_1760380.html
$6+ BILLION: Amount of revenue earned by top 5 drugs 3rd Quarter 2012:
www . fiercepharma . com/press-releases/drugscom-releases-q3-sales-top-100-us-drugs-singulair-drops-nexium-and-abil
$307+ BILLION: Amount spent on prescription drugs in USA 2010
http:// mobile . pharmacytimes . com/publications/issue/2011/May2011/Top-200-Drugs-of-2010
Marc Stephens Is Insane, yep, unfortunately people die.

Narad, I expected no less from you. Bring up Vitamin C & ignore his other research, publications, and education. Well done!

Chris, you are apathetic. Like a misguided chicken little dissumulator. It is truly sad that you spend so much time trying to prove a False Positive by claiming that I am defending a fraud without any evidence, because you're unable to cite said evidence, because it doesn't exist!

MarkL, who famously has no FACTS to support his position: "MarkL, please cite any post(s) & their dates that buttress your misguided belief that I “claimed that” I was “not asked for results.” At least I am an Adult who does not need to stoop down to your level of adolescent name-calling."
Or do you clearly have no intention of answering any of the questions put to you, and are more intent on frustrating the debate than in joining it"?
Please do not feed MarkL "London Broil."

flip, do you understand the meaning of False Positive? Can you prove the devil? Do you have a Gish Gallop Poll (or Pole) where you live? Do you have trouble understanding American English? Is it not your American native language? Have you ever opened Black's Law Dictionary? It's not my responsibility to "even come close to proving that Burzyinski has published evidence." You as a Human Being; if you are indeed one instead of a Bot or Pet Rock, should be inquisitive enough to research things yourself instead of asking people to spoon feed it to you. Is the above post which has at its end, the HighWire Stanford University edu site, the "Research" you want?

Lawrence, read between the lines.

JGC, OH MY Goodness! Homeopathy!! Why that must be like sacrilegious!!! It reminds me of the story of the FDA vs. John S. Najarian:
http:// dash . harvard . edu/bitstream/handle/1/9453691/mstennes.pdf?sequence=1

www . ncbi . nlm. nih . gov/m/pubmed/7575112

www . mndaily . com/1996/02/22/najarian-acquitted-all-counts

http:// minnesota . publicradio . org/display/web/2006/02/28/uofmhospital

www . surg . umn . edu/Faculty_Alpha/najarian_john_s/home.html

www . surg . umn . edu/Faculty_Alpha/najarian_john_s/najarian_cv/home.html
flip, i see the idea lightbulb appeared above your head! Yes, I am saying I'm neutral as indicated in my 12/1 post.
Ever heard of the American Language?

Narad, do you need glasses? I'm concerned about your eyesight. Have you considered LASIK? Did you see the NCBI NLM NIH gov site link? I didn't get this from Randy Moss. People can whine about ITC all they want.

Krebiozen, I really don't give a "flip" about tu quoque. Do you know what law & regulations are? Black's Law Dictionary? How to file a lawsuit? So your fallacy is that to neutrally post things so people can draw their own conclusions about the credibility of the information ... oh wait! I think this is one of the reasons that the American Revolution against the British happened! Here's my suggestion. Take your issues to the FDA.

Chris is a true blue Gleevec fanatic. Side Effects Associated With GLEEVEC: Some of these side effects may be minor, others could be very serious. Severity of some side effects may be reduced with the help of other medicines, others may require stopping therapy for a while or changing the dose. In some cases, therapy may need to be discontinued. Serious side effects: Severe fluid retention (holding water) & swelling, Cytopenias (reduction of certain elements in blood circulation), Severe congestive heart failure (impaired ability of the heart to pump blood) & left ventricular dysfunction (impaired functioning of the left side of the heart), Severe liver problems (hepatotoxicity), Hemorrhage (abnormal bleeding), GI perforation (holes in the stomach or intestine), Hypereosinophilic (a condition with increased eosinophils, which are a type of white blood cell) heart disease, Skin reactions (such as fluid-filled blisters), Hypothyroidism (reduction in thyroid hormones), Potential toxicities from long-term use, specifically liver, kidney, and/or heart toxicities, Potential harm to an unborn child, Growth retardation (slowing of growth), Tumor lysis syndrome (electrolyte disturbance), Dizziness, blurred vision, & somnolence. Common side effects: Almost all patients experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects that you may experience include: Fluid retention (holding water), Muscle cramps, pain, or bone pain, Abdominal pain, Anorexia (loss of appetite), Vomiting, Diarrhea, Decreased hemoglobin (decrease in blood cells which carry oxygen), Hemorrhage (abnormal bleeding), Nausea, Fatigue, Rash. It is especially important to tell your doctor about any fever, shortness of breath, blood in your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, symptoms of heart failure, or if you have a history of heart disease or risk factors for heart disease.
www . gleevec . com/patient/kit-gist/gleevec-therapy/side-effects.jsp?usertrack.filter_applied=true&NovaId=4029462064338618122
Sounds like fun!

Science Mom, you disappoint me greatly, but I guess there is a lot of science involved in using the "Search" function for this blog. So ... you made the claim but can't remember your claim. But this's the same NIH which funded him 1974-1976! :-o
http:// books . google . com/books?id=ImIJAAAAIAAJ&q=Burzynski&dq=Burzynski&lr=&as_drrb_is=q&as_minm_is=0&as_miny_is=&as_maxm_is=0&as_maxy_is=&num=100&as_brr=0&output=html_text&cd=52
MUAH !! (Multiple Unsuccessful Attempts at Humor) Please cite any "FACTS" that substantiate your hallucinatory fantasy that Burzynski is my mate. NCCAM funds Ducks? The "clinical trials" in the above post to Science Mom where I provide a link for HighWire Stanford edu?

MarkL, I just think it pointless to argue with a LIAR who has no reply for "MarkL, please cite any post(s) & their dates that buttress your misguided belief that I “claimed that” I was “not asked for results.” At least I am an Adult who does not need to stoop down to your level of adolescent name-calling." You LIE when you write that I am "a Burzynski fanboy" as you have not onw iota of evidence in support of that: because i dont live in the same State as him, have never met him, have never communicated with him, don't personally know anyone who has met him, and have never received anything from him. Who LIES when he writes that I am one "who ignores any request for even the smallest sliver of evidence that the object of his perverse support is anything other than a con man" since you don't have a scintilla of evidence that I support SRB or in the least exhibit perverse support for him or "yet continues to post advertorials and puff pieces" which is another LIE as I was the one who pointed out on 11/30/12 the Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy...' & pointed out "Orac writes: “[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy…” and you LIE when you post that my information is "from dubious sources as “proof” that the maverick doctor deserves other than ridicule and condemnation." You cite not 1 dubious source & you also conveniently do not point out that I'm the one who pointed out on 11/30/12 the National Cancer Institute at the National Institutes of Health & American Caner Society had information re Antineoplatons & SRB, thusly proving the last sentence of your post to also be a LIE.

W. Kevin Vicklund, you're the one who asked: "Whose ass did you pull that number out of?" Didn't you feel it come out of you right after you realized what a stupid question that was to posit in that manner? So you blithely ignore the author of the article & write her off as: "Not a reliable source." However, you write "no source other than Burzynski" as if you were in the room with writer of the article, and state no FACTS to support your claim. You also write "author not involved in the trial in any capacity." However, this proves nothing as the information could have been obtained from Attorney Rick Jaffe or through a Fredom of Information Act (FOIA) request or by other means. Would you care to try & pull a rabbit out of a hat?

Marc Stephens Is Insane, are you a curmudgeon? Because there is a Search function on the blog which allows you to search for "Whitaker," and come up with nothing. Please cite the post(s) & date which contain Whitaker as the source.

Alain, I think there are quite a few "characters" trying to "ventilate" my posts without much success.

Narad, if you can't remember what you wrote that I'm replying to, then maybe you're just writing superfluous material.

flip, why am I not surprised you need someone else to reply for you? Don't worry, people who have a lollipop as their picture generally have no idea what someone is trying to say to them.

By Didymus Judas Thomas (not verified) on 04 Dec 2012 #permalink

MSII,

not counting the two anonymous doctors in the new movie trailer)

FWIW I was wondering about those two, even to the extent of taking screen caps and zooming in on their name badges. The first one seems to be called "Ali B" something, and is a hematologist/oncologist. The second one is Dr. Eric Carlson MD who is described as the head of Oncology at the University of Tennessee Medical Center on multiple websites (10,500 host the identical story, to be precise) but is in fact part of the oral and maxillofacial surgical team there. He is also "Chief, Oral and Maxillofacial Surgery, University of Tennessee Memorial Hospital and University of Tennessee Cancer Institute" and "Professor and Chairman, Director of Residency Program, Department of Oral and Maxillofacial Surgery, University of Tennessee Graduate School of Medicine".

Dr. Carlson was, according to the aforementioned multiple websites, treating Betty Whyte for Merkle [sic] cell cancer before she was treated by Burzynski though he refers, confusingly, to "Mrs Wright" in the clip. I think she may be one of the patients seen in the clip (2:37). I can't find any more information about her case anywhere, and I can't even be sure that this is the patient Dr. Carlson is discussing.

By Krebiozen (not verified) on 04 Dec 2012 #permalink

DJT< regarding Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
This paperdoes not give results from a double-blind, randomised clinical trial. Instead it includes subjects from four different trials, without stating what trials they were part of. Burzynski has cherry picked subjects from separate trials to make a false case for antineoplastin efficacy.

Note that subject numbers, even across four trials, is low (18 patients)

Further teh subjects aren't matched with respect to cancer stage, etc.: while the paper states that 14 patients had diffuse intrinsic tumors it does not state what the remaining four patients had.
Even with the cherry picked best cases antineoplastons were at best marginally effective--12 of 18 patients suffered recurrence.

The paper states 12 patients had radiation therapy or chemotherapy simultaneously or prior to receiving antineoplastons but does not match outcomes to treatment, so there's no way to tell if the marginal success he's claiming for his tehrapy can be attributed to to antineoplastins or to standard chemo/radiation.

In short, this paper is a massive fail as far as providing evidence antioneoplastions effectively treat paper. I know that Journal Integr Cancer Ther is a low impact journal, but I'm still surprised they'd accept an submission this flawed for publication.

Diddums,

In answer to your pathetic evasion:

Diddums, you said:

“herr doktor bimler, where does Chris’ post state “clinical results?” It states “clinical.” As far as I’m concerned that left it up to my discretion as to what to choose to post.”

Lets look at what Chris said:

“Tell me the title, date and journal of the PubMed indexed paper where the RESULTS of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.”

To make it easy I have capitalized the relevant word in Chris’s request.

Still having difficulty Diddums?

We will await the data.

As for my having no facts to support my position that Burzynski is a con-man.............. What more do I need? It isnt my job to show that his medicine doesnt work, it is up to him to get FDA approval.

Burzynski has failed to provide ANY evidence that his treatment works. After closing on 4 decades of experimentation, he cannot put together ANY results that support the efficacy of Antineoplaston therapy. Nothing. Zip. Nada.

Yet still he relies on fanboys like you to fight for his reputation. Why has he not sued people for calling him a money grubbing worm? Why does he answer almost universal condemnation and ridicule with advertorials and puff pieces in woo-friendly journals.

So what of your contribution here? What have you actually achieved but put forward the same tired arguments supported by the same evidence free bullsh1t that the brave maverick's supporters always produce? Arguments and articles that have been dissected and repudiated a dozen times or more here and in many other blogs & journals.

Burzynski is a fraud, a description that applies equally to you and your tired word salad of copy/pasta bull.

Didy,

Are you a complete and total moron? Do you read or even look at any of the links you provide?

No mention of Julain Whitaker? Look at the very first document here, in the LINK YOU PROVIDED. A newsletter from Dr. Julian Whitaker titled "The FDA's Unholy War Against Dr. Burzynski".

I didn't make up a Whitaker refernce out of thin air. You gave it to us. Do you have the class to admit you were wrong and say "oh yeah, there was a document from Julian Whitaker in there, I am sorry I made a mistake"? Those words will never issue forth from your keyboard. Are you ever wrong about anything?

And yes, of course people die, but you presented two newspaper articles about Mary Jo Hofness from last year as proof that Burznyski is not a fraud. I am merely pointing out, if you want to use the same patient as an example, that she died several months ago. Don'ty you understand when you post newspaper articles we can do the same?

The last thing I will ever write to you, Didy, is a huge question. You keep denying you are shilling for Bursynski and claim you are not here to support him. Please then, tell us in one or two sentences, why exactly are you here, posting lengthy comments attrempting to "show us" the other side?

By Marc Stephens … (not verified) on 04 Dec 2012 #permalink

Oh, and Didy, take a look at this link YOU SENT US: another Julian Whitaker newsletter, titled "The FDA's Latest Abuse of Power" from 1996 (it's not the first document here, you have to scroll down a bit...that means use your mouse to move the words up on your screen so you can see the rest of the documents.

https://docs.google.com/viewer?a=v&q=cache:gU3fCI4uOhoJ:www.clintonlibr…

Yeah, I invented the Julian Whitaker references. I await your apology.

By Marc Stephens … (not verified) on 04 Dec 2012 #permalink

And Didy, since you love newspaper articles so much, why don't you read this, a recent profile piece from 2008 from the doctor's own hometown newspaper. I know it's long, but maybe you can read it in chunks and take a nice lie-down in between if your brain starts to hurt.

Tell me this is a man you would trust with your life, or a loved one's life. Who talks like this to reporter when they know they're on the record? Calling a reporter a shit with a little brain? The man is deranged, and this brilliant reporter didn't try to hide his contempt for Burzynski.

http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-bur…

By Marc Stephens … (not verified) on 04 Dec 2012 #permalink

Do you have trouble understanding American English? Is it not your American native language?

Pretty rich coming from someone with the communication skills of a doorknob.

Science Mom, you disappoint me greatly, but I guess there is a lot of science involved in using the “Search” function for this blog. So … you made the claim but can’t remember your claim. But this’s the same NIH which funded him 1974-1976! :-o
http:// books . google . com/books?id=ImIJAAAAIAAJ&q=Burzynski&dq=Burzynski&lr=&as_drrb_is=q&as_minm_is=0&as_miny_is=&as_maxm_is=0&as_maxy_is=&num=100&as_brr=0&output=html_text&cd=52

So you are using a book (with an invalid link) to prove something? What is the grant number? You have produced so much drek here I really don't even know what claim you are responding to. That's why we use quoting, you should try it and provide any statements you are responding to. You seem to be the one with unlimited time on your hands, not me.

MUAH !! (Multiple Unsuccessful Attempts at Humor) Please cite any “FACTS” that substantiate your hallucinatory fantasy that Burzynski is my mate.

Your defence of Burzynski is so charming but I could be wrong and you are either paid to do so or are so enamoured with him in a rather unhealthy way that you don't mind making a complete arse of yourself.

NCCAM funds Ducks? The “clinical trials” in the above post to Science Mom where I provide a link for HighWire Stanford edu?

Burzynski really needs a better class of fanbois; I actually made a helpful suggestion but you are too dim to grasp that. So what about clinical trials. He's been allegedly running them for over 30 years with nothing really to show from them. And as I stated earlier, he has no intention because he is bilking a good living out of desperate people and has insulated himself rather well.

By Science Mom (not verified) on 04 Dec 2012 #permalink

Hey, there are some pretty intelligent electronic doorknobs out there now. Computer chips, memory, etc. Don't insult the hardware industry!

And for the record, I speak Canadian English, eh? Et francais aussi. But not American English. Unless I take a trip to Burlington Vt. and I drop the "u" in words like colour and neighbour.

By Marc Stephens … (not verified) on 04 Dec 2012 #permalink

On the Burzynski Clinic website, there's a relatively new link to an interview with Stan published this summer in some rag called "Alternative Therapies". In his own words, he says he was receiving a substantial salary in Poland and got a research job at Baylor as soon as he arrived in the US (he says at that point he still could barely speak any English.) So what's all this BS about coming to this country with $15 in his pocket and not being able to pay for staff or research protocols? He only struck out on his own after he had being employed here for some time. He didn't set up his clinic the second he stepped off the boat, so what does that "$15 in his poecket" even mean?

More seriously, in this interview he addresses everything: the clinical trials, the adversaries trying to stop him, the cost of his treatments, "targetted" gene therapy, the new era of antineoplastons, everything. All paranoia and lies, of course, like this. (Sorry for the formatting, it's cut-and-paste from a pdf:)

Dr Burzynski: When patients come to us, most of them are treated
in our oncology practice. We try to help obtain payments from the
insurance companies for them—they have insurance policies and
for most of them, insurance covers the treatment which is done
here. If you are talking about antineoplastons clinical trials, we
provide medication free of charge, which costs us a lot of money.
Annually, we spend $5 to $6 million for this purpose. If you have
support from the government, then this money probably would
come from the government. But instead we have to generate the
money through our business activities and use this money for the
approval process. It can be done. In medical history, it was always
done this way. Only recently have the doctors become the slaves of
organizations like the NCI or pharmaceutical companies. We are
independent and can do whatever we would like to do without being
manipulated by the other agencies...

I almost spit coffee when I read this nonsense:

ATHM: Do you think that understanding in the medical community
about your research is improving with time or evolving?
Dr Burzynski: Absolutely. Some of the brightest oncologists are
working together with us. We have a group of about 100 top oncologists.
We are treating patients together with oncologists from
all over the world. We are talking about the brightest guys. The rest
of the club does not understand what we do at all and hate us. They
would like to get rid of us. They hate to see our good results. But
this crowd also will change if the breakthrough comes. So at this
moment, we have to convert oncologists one by one. Of course,
I am giving lectures at the oncology congresses, but only a few of
these doctors will pay attention to what I have to say because I am
not from a big medical institution. They don’t believe something
can come from a small clinic, a small research center. They all assume
research must come from a big pharmaceutical company or
big institutions. Unfortunately, not much good came from these
institutions within the last decade. But a number of doctors are beginning
to understand what we do, and the number of those who
would like to be trained in our strategy is increasing all the time.
We have oncologists coming to us from various countries almost
all the time to learn how to use our approach.

Please read the entire thing. I'm sure you'll find things to pick apart in every single sentence.

http://www.burzynskiclinic.com/Burzynski-Interview.html

By Marc Stephens … (not verified) on 04 Dec 2012 #permalink

@Krebiozen,
Regarding Reich, it's beyond serious dispute that he had some kind of mental health issue, but it's problematic to treat it as an issue in appraising his work. From all we know of mental illness, it's VERY unlikely that he ever had a problem that was not with him all along. It is plausible, however, that his symptoms and overall condition worsened over time. The period from the late 1930s onward, when he evidently went through significant turmoil in his personal life, could be especially significant.

By David N. Brown (not verified) on 04 Dec 2012 #permalink

David N. Brown,
I was using the terms "sane" and "bonkers" in an informal layman's sense, not necessarily referring to mental health issues, rather to extremely unusual belief systems.

However, when you consider how Reich was treated I don't think it is very surprising that he had some sort of mental breakdown. His ideas may have been wrong, but destroying research and burning books is no way to deal with that, in my view.

When I was younger I spent a lot of time reading Reich's works, and what others wrote about him. I have a book of his letters and journals that cover the period when he asked Einstein to take a look at one of his orgone accumulators. The repeated refrain, "Still no word from Einstein" is very sad.

By Krebiozen (not verified) on 04 Dec 2012 #permalink

It’s a valid link, but Didy puts in all these annoying spaces in order to carpet bomb us with mutiple links in a single comment. Here it is without the spaces, but there’s nothing earth-shattering there:

Thanks MSII; I thought I had gotten all of the spaces (cripes you don't need that many to slip through the filters). Yea, looks like Burzynski is in good company with Gerson and Hoxsey. Diddums shouldn't be drawing attention to that hot mess.

By Science Mom (not verified) on 04 Dec 2012 #permalink

DJT,
The bite-sized posts are a great improvement. A statement of what you are asserting, followed by evidence to support it, would improve them even more.

Jodi Fenton – Anaplastic Astrocytoma Grade III

I'm sure you are not suggesting in any way that Jodi Fenton's case is evidence that Burzynski's treatment is effective, but you still might be interested in what jli, an experienced histopathologist, has to say about it (Testimonial 1).

So based on what we are told and what we can deduce from the documentation, there are two possibilities:
1) A 2 cm anaplastic astrocytoma was biopsied. Without further intervention it shrunk to 0,5 cm.
Antineoplastons made the rest go away; this is in fact what the movie claims.
2) A 2 cm anaplastic astrocytoma was biopsied and then surgically removed. The subsequent inflammation
resolved on its own.

You can see the medical records that jli refers to here.
I also notice that the tumor measured 2.2 cm x 1.8 cm x 1.5 cm on her MRI, which is 5.94 cm³. After surgery the size of the tumor was 0.17³ which means that 97% of the tumor was removed during surgery, possibly more if you allow for post-operative inflammation as jli mentions. Not bad for an "inoperable" tumor.

By Krebiozen (not verified) on 04 Dec 2012 #permalink

Typo - that should read "the size of the tumor was 0.17 cm³ ".

By Krebiozen (not verified) on 05 Dec 2012 #permalink

That headline should really read, "Burzynski takes credit for Surgical Brain Cancer Cure".

By Krebiozen (not verified) on 05 Dec 2012 #permalink

@Diddums

Perhaps your response made sense to you, but it doesn't match up with what I last wrote. In fact, it just shows you to be sidestepping anything and everything that we say.

I wrote:

I will only bother in reposting what Krebiozen said:

DJT,

You still don’t understand what the tu quoque fallacy is, or what a controlled clinical trial is, apparently. You swamp this blog with references to articles about Burzynski, none of which are good evidence of anything, and then claim you are not supporting him. What was the point of posting all those links? If you are trying to destroy any small amount of remaining credibility you have left, don’t bother, you lost it all some time ago.

and Science Mom and I are in agreement:

Sorry, can’t keep track of your incoherent word salads.

I have no idea what you were trying to say to me.

And you wrote back:

flip, I knew in your rigorous search for the truth that you would want to know any new information on SRB that comes to light

So how in the world does one lead into the other? (Added, after reading the full comment: I see now that he's replying to various comments but there's no way to tell what sentences reply to what comments. I can't be bothered scrolling up to figure it out, so here it remains...)

flip, do you understand the meaning of False Positive? Can you prove the devil? Do you have a Gish Gallop Poll (or Pole) where you live? Do you have trouble understanding American English? Is it not your American native language? Have you ever opened Black’s Law Dictionary? It’s not my responsibility to “even come close to proving that Burzyinski has published evidence.” You as a Human Being; if you are indeed one instead of a Bot or Pet Rock, should be inquisitive enough to research things yourself instead of asking people to spoon feed it to you. Is the above post which has at its end, the HighWire Stanford University edu site, the “Research” you want?

My question required a yes/no. I do not see such a sentence above. And no, American English is not my native tongue. I do however, speak Australian English, which is hardly different. And I use proper grammar and sentences that flow on from each other from one thought to the next in a manner that can be followed easily.

Perhaps you need to step out of your geocentric sphere for 2 seconds and recognise that the internet is international and that those international people can understand how to write English far better than you can. And by the way, I was attempting to defend a possible non-English speaker. I was giving you the benefit of the doubt, and for that, I guess I'm sorry. You're not struggling with ESL, you're apparently just an idiot who doesn't know how to write well.

-- By the way, is this even grammatically correct? "Is it not your American native language?" Sounds like you transposed your words.

I'm also not sure you actually know or understand the references we made and you 'satirised'.

As for requiring you to post evidence, maybe you need to clarify why you're here and why you're posting. We're talking about one person who is supposed to be curing cancer. WTF are you talking about?

And I have yes, been looking at files and publications and reading various things here and there. I don't have a lot of time to read everything; but the world and internet is large and you can't just 'research' something based on doing a google. You and Jenny Mcarthy would get on fine I'm sure.

Yes, I am saying I’m neutral as indicated in my 12/1 post.

That isn't exactly clear from your ranting. If you'd like to make it clearer, start writing in a way people can understand you. I'd recommend replying to one person at a time, and using shorter comments, and perhaps some decent paragraph styling.

By the way, I don't understand this need to remain neutral. Science doesn't give a flying f* about being nice to everyone, it picks sides. You're either wrong or you're not. Big Pharma can be wrong in certain instances; it can be right in others. The bold mavericks are hardly ever right; but can be in rare occasions. Like the others have been trying to say to you: we do not need to criticise everything to criticise Burzyinski. If you don't understand, here's a link:
http://yourlogicalfallacyis.com/tu-quoque

flip, why am I not surprised you need someone else to reply for you? Don’t worry, people who have a lollipop as their picture generally have no idea what someone is trying to say to them.

Or you dimbulb, I didn't want to reinvent the wheel as I was in the middle of five other things and they had said what I had wanted to in a perfectly eloquent manner. Feel free to use all the ad hominems you like, it won't make you any more legible or my re-use of their comments any less apt.

Feel free to continue blathering to yourself, I am not going to bother reading your replies as they're so unintelligible, evasive, and full of ranting.

(To regulars, I get the feeling this crank is a libertarian - 'balance' and 'freedom' seem to be what he's aiming for, and the right for customers to get screwed because it serves them right)

@MSII

And for the record, I speak Canadian English, eh? Et francais aussi. But not American English. Unless I take a trip to Burlington Vt. and I drop the “u” in words like colour and neighbour.

Je ne suis pas Francais, ou Canadien. Mais j'ai appris un peu a l'ecole.

Unfortunately I have also taught myself American spellings due to its commonality for overseas clients. It can be quite frustrating to remember and tough when your spellchecker doesn't do its job. Canadian English - don't you just put an 'eh' on everything at the end? ;)

So what’s all this BS about coming to this country with $15 in his pocket and not being able to pay for staff or research protocols?

I pointed that out already in one of my comments about the files on Josephine Jones' site.

Diddums, you may wish to remain ignorant of tu quoque, but unfortunately I can explain it so simply that it will be apparent to everyone that you know you're not arguing in good faith.

A tu quoque argument is one in the following form:

1) You shouldn't talk about A doing wrong if B did something worse.
2) B did something worse.
3) Therefore you shouldn't talk about A doing wrong.

Sadly for you, premise 1 is bullshit and that makes the whole argument bullshit. You may try - you've already tried - to pretend that you aren't trying to disrupt and shut down discussion of Burzynski's wrongdoing; that too is bullshit. There's no point in dignifying it with any other name.

By Antaeus Feldspar (not verified) on 05 Dec 2012 #permalink

Comments re 12/4 -
__________________________________________
JGC, you remind me of:
www.ncbi.nlm.nih.gov/books/NBK13919
Under "Pharmacologic and Biologic Treatments"
" [P]reliminary data recently were criticized by respected mainstream scientists as uninterpretable, and the therapy as useless and toxic." (And it cites):
"Anonymous Experts say interpretable results unlikely in Burzynski's antineoplastons studies. Cancer Lett. 1998;24:1–16. [PubMed]"
But the link to this cite doesn't bring this "Anonymous" up & a search doesn't either. Seriously? Anonymous?
__________________________________________
MarkL, WoW! You successfully posted basically the same thing on 11/29 & 12/4!! Have you been following along with the rest of us? Because since my 2nd post on 11/28 & Chris' immediate missrepresention of what I wrote, and my request on my subsequent post "I will be happy to accept your apology," and Chris' follow-up 11/29 post sans apology, herr doktor bimler's "piling on," Chris' ensuing excuse for an apology, my post that Chris use the "Magic Word," Chris' concomitant non-apologetic post sans "Magic Word," Science Mom's jumping on the bandwagon, JGC's open season, Chris' unapologetic "Magic Word" unaided post, Denice's joining the circus, JGC's blathering epiphany, Lawrence's claim jumping, Chris' impenitent absent "Magic Word" slurry, herr doktor bimler's supplanting post, JGC's off-shoot, MarkL's usurping, herr doktor bimler's aside, Todd W's oppugn, flip's flippant addition, Peebs' elucidation, Denice's hiccup, Chris' unrepentant "Magic Word" using rehash, Narad's penny pinching post, Denice's insider comment, Chris' unremorseful aside, Lawrence's 11/30 whiny repository, MI Dawn's hijacking, JGC's goulash, Chris' remorseless plea, Chris' implacable uncontrite potpourri, Chris' rehash, Lawrence's linguine, Chris Goes GLEEVEC: "I don't know what 'apology' means" time-wasting unapologetic post, Narad discovers Wall Street & Gordon Gekko:
www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110…

www.sec.gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex9…

12/1 - I post "Chris, why have you not apologized for misstating my argument?" Chris' whines "Actually I did," without any reference, twice, then whines again, and again, MarkL again interjects nothingness, Science Mom searches for a UFO, 12/2 Narad goes "George Bush," flip flips out, Lawrence is confused, flip flip flops, 12/3 Chris chrysalises, Chris frantically searching for more ways to keep from apologizing, MarkL searches for pork pie in the sky, flip shows how to post posts posthaste, 12/4 MarkL re-posts basically what he reposted 11/29, then lies down but doesn't play dead, Marc Stephens Is Insane goes Insane, then after posting: "The last thing I will ever write to you," writes more, and MORE, AND MORE, Science Mom admits: "I could be wrong."
__________________________________________
Marc Stephens Is Insane, are you Insane? Egad! HIS name is on 1 document out of 49!! I can understand why you are morally outraged!!! Do you think that I have a photographic memory so that I remember every name I read when reviewing all the information I go through in a day? Since you didn't back up your post with "FACTS," I just instinctively thought you were in denial. You actually got that one right! Unlike Chris, I will actually apologize for not consuming enough "Brain-Food," or is that considered Homeopathic? I don't use a keyboard, I project my thoughts like Dragon.
Please provide the "FACTS" that shore up your solecism that by posting 2 newspaper articles, I was attempting to provide "proof that Burznyski is not a fraud." Who's just "attrempting (sic) to “show"" you "the other side?" I'm presenting both sides. I don't use a mouse. That would be cruelty to animals, which wouldn't make PETA happy. Oh My! HIS name is on 1 document out of 42!! How could I not remember THAT!!!
THAT man could be a little man. Do you know how tall he is? I couldn't tell from on-line pictures. But what a fabulous piece. Just look at how many people commented on the story on that site! O!! This is the guy cited on Wikipedia under SRB's Clinic/Documentary pg. where he comments on it while admitting he didn't watch it. What kinda "Hack" does that kind of Yellow Journalism?
What ever should I think about this Congressional testimony?:
www.heartmdinstitute.com/health-concerns/cancer/must-read-congressional…
And my below links for Science Mom?
__________________________________________
Narad, pretty rich coming from someone who has no response to my three 12/4"The Land of the Brave post."
__________________________________________
Science Mom, as someone pointed out later in the blog, there was a reason why I was adding spaces to links, but the reason is I got tired of Orac's "Spam Bot" link-blocking. Who's doing the most research around here to respond to people's posts? You? Yes ... you are wrong; maybe in more ways than 1. Read this:
12/6/12 Texas Medical Board Dismisses Case Against Cancer Doctor Burzynski:
http://healthimpactnews.com/2012/texas-medical-board-dismisses-case-aga…
FDA requiring Radiation in Phase 3 trial:
www.heartmdinstitute.com/breaking-news/cancer-pioneer-faces-trial
Petition to White House:
www.cancertutor.com/Government/Government_and_Cancer.html
Antineoplastons clinical trials:
http://imsdd.meb.uni-bonn.de/cancernet/600743.html
__________________________________________
Marc Stephens Is Insane, no, it's to bypass the Orac Spam Bot Link Block.

By Didymus Judas Thomas (not verified) on 06 Dec 2012 #permalink

Still no evidence?

Just more copy/pasta?

Yawn.

Troll.

@ Didy,

I appreciate your post being more ventilated but haven't read all your previous post, I lost the context but fear not, I'll try to read some of your evidence (found in this latest post) and report back.

Alain

What in holy hell was that from Diddums?! Trying to read his post is what I would imagine being on an acid trip is like.

By Science Mom (not verified) on 06 Dec 2012 #permalink

Trying to read his post is what I would imagine being on an acid trip is like.

More like Ritalin with a chaser of Nyquil. But, hey, it's discovered the horizontal line, so there's that.

Well, at least he seems to be learning. But he could try harder at making sentences shorter and allowing one thought for each. Perhaps somewhere in that mess is an actual point....

Perhaps somewhere in that mess is an actual point….

When someone thinks Black's Law Dictionary is some sort of really impressive mention, I'm not encouraged.

Anyone besides me notice that some of Orac's comments show up on:
----—------------------------------
www. sciencebasedmedicine. org
-------------------------------------
www. sciencebasedpharmacy. wordpress. com
-------------------------------------
www. skepticalhumanities. com
-------------------------------------
www. skeptico. blogs. com
-------------------------------------
www. skepdic. com
-------------------------------------
www. anaximperator. wordpress. com
-------------------------------------
www. beforeitsnews. com
-------------------------------------
www. doubtfulnews. com
-------------------------------------
www. hepinfo. net
-------------------------------------
:-)

By Didymus Judas Thomas (not verified) on 06 Dec 2012 #permalink

Anyone besides me notice that some of Orac’s comments show up on: <mumble>

Yes.

By Bill Price (not verified) on 06 Dec 2012 #permalink

Orac has commented twice on this thread and I cannot see any sign of those comments being recycled elsewhere. So the answer is "No, it's just you".

By herr doktor bimler (not verified) on 06 Dec 2012 #permalink

hdb, it seems interesting that we are taking different meanings of DJT's word "comments" and come up with different but correct answers to DJT's question.
You read "comments" as referring to blog comments, such as these. You correctly answer that you've not seen Orac's words repeated from comments here to comments elsewhere.
In line with DJT's looseness of thought and expression, I read his word "comments" as referring to Orac's thoughts, and expression thereof, literal and paraphrased, in his articles as well as in the comments section here. My answer reflects the general applicability and insight of Orac's thoughts and expressions — such that most blogs frequented by people who think are likely to contain many of the thoughts, expressed literally or paraphrased. This is not even taking into account that Orac's work is quoted by his friend, and others, because of his perspicuity in the matters he writes on.
What DJT actually meant may never be known, even to DJT — he hasn't exhibited much in the way of clarity.

By Bill Price (not verified) on 06 Dec 2012 #permalink

Science Mom, I've been on several excursions via LSD and they made a lot more sense.

If I were looking for info on Burzynski because I was considering utilizing his services and found these addled prattlings of DiddyMau5 JT, I'd drop the idea like a bad habit.

By al kimeea (not verified) on 07 Dec 2012 #permalink

DJT,
I'm disappointed you haven't responded to my comment above, pointing out that at least 97% of Jodi Fenton's tumor was surgically removed before she started antineoplastons. Yet the YouTube video you linked to claims that, "Jodi Fenton was cured of a Grade 3 Anaplastic Astrocytoma after being treated only with Antineoplastons". Do you anything to say about that? Doesn't that make you wonder just a little bit about the honesty of the rest of Burzynski's propaganda?

Anyone besides me notice that some of Orac’s comments show up on...

No, but I comment on most of those blogs from time to time, since they all cover subjects I am interested in. So what?

By Krebiozen (not verified) on 07 Dec 2012 #permalink

@Diddums

Anyone besides me notice that some of Orac’s comments show up on:

BWAHAHAHAHAHAHA!

Oh, thanks, I needed a laugh. :)

But seriously, maybe DJT is just a shill for Big Skeptics, promoting those evil websites that tell us we should be using science in our medical decisions. *claps* Very good, DJT, Lord Draconis will be along shortly to give you your prize...

Seriously? Anonymous?

Don't know why I'd remind you of this letter, as neither I nor anyone else is criticizing Burzynski because anonymous scientists question whether his studies could produce interpretable data. I'm quite willing to stipulate that they may be wrong and --who knows?--maybe Burzynski's studies could provide interpretable data. The real problem is that there's nothing to attempt to interpret: Burzynski has never published data from the clinical trials he's supposedly been conducting for a couple of decades.

Meanwhile, studies have been published which found antineoplastins ineffective. Like those found at the link you provided, which you conveniently ignored to focus on the whole anonymity red herring (Green S. Antineoplastons: an unproved cancer therapy. JAMA. 1992;267:2924–8; Buckner JC, Malkin MG, Reed E. et al. Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc. 1999;74:137–45.)

12/5 comments:
__________________________________________
Krebiozen, so, what do histopathologists do? Hysteria-of-Pathological-Liar-ists?
http://en.m.wikipedia.org/wiki/Histopathology
The Microscopic examination of tissue on glass slides.
Anaximperator blog:
So, what's this person's motivation?
"Blogging against alternative cancer treatments."
Well, THAT answers THAT question!
jli's "theory" re Jodi Gold Fenton "becomes problematic" (I use jli's own words) when the reader is advised not to just look at the highlighted yellow portion but where "it tells us that the lesion could also be a lymphoma or an inflammatory process..."
jli does not point out that pg. 5 of the Medical Records indicates: "Other MR spectroscopy features. in particular the decreased lactate, make the diagnosis of lymphoma or abscess or other infectious process less likely."
jli wrote:"At the start of the testimonial we were told that the astrocytoma was inoperable. Well – it was accessible for biopsy, so how then could it have been inaccessible to surgery?"
Well, JGF says that it was "inoperable," so who told her that? Was she given inaccurate information by a medical professional?
pg. 9 indicates the Biopsy was a "Stereotactic Biopsy"
http://neurosurgery.ufl.edu/residency/about-us/clinical-specialties/ste…
which is supposedly a "minimally invasive procedure."
jli keeps suggesting that surgery was performed after the biopsy but does not cite any supporting evidence.
Pg. 2: 2 cm. approximately - 5/11/2000
Pg. 3: 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm mediclateral - 5/11/2000
Pg. 5: 2.67 X 2.02 X 2.55 cm. approximately - 5/11/2000
Pg. 6: 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm - 5/11/2000
Pg. 8: 1.0 cm in length x 1.0 to 2.0 mm in thickness Labeled "biopsy left parietal mass": The specimen consists of a core of gray tissue 5/15/2000
Pg. 10: 6/1/2000
0.2 x 0.1 = 0.02
0.5 x 0.3 = 0.15
= 0.17
Pg. 13: 6/1/2000
0.3 / 0.2 / 0.06
0.5 / 0.3 / 0.15
= 0.21
The truth is out there somewhere.

By Didymus Judas Thomas (not verified) on 07 Dec 2012 #permalink

12/5 comments:
__________________________________________
flip, what did you say?
See my 12/4 response to: "Lawrence, read between the lines."
Have you ever considered that maybe you're posting too much garbage if you need to scroll up to remember what you posted?
I post replies in the same order as the posts I'm replying to.
12/2 my post re Part II of the SRB documentary was commented on 3 posts later by you on the same day where you whined that i didn't respond to your Dingo Didgeridoo Kangaroo questions, and then the 4th post on 12/3 you again posted away about SRB & later posted: "I have no idea what you were trying to say to me." So the 8th post of 12/4 was my: "flip, I knew in your rigorous search for the truth that you would want to know any new information on SRB that comes to light," because I knew you would want to watch Part II of the Documentary to learn if any of your questions are answered.
For someone who "can’t be bothered scrolling up," you sure had time to post a lot.
Yes/No.
Really? We all know from History that except for the aboriginal people, everyone else from Down Under are decendants of criminals, Right? :-)
How's your Geosphere? And the Vegamite sandwiches?
I like transposing words to make people think.
I think I've made it clear why I'm here:
12/4 to MarkL: " you also conveniently do not point out that I’m the one who pointed out on 11/30/12 the National Cancer Institute at the National Institutes of Health & American Caner Society had information re Antineoplatons & SRB."
Need some more? Check out my above post with links to SRB's SEC filings.

By Didymus Judas Thomas (not verified) on 07 Dec 2012 #permalink

12/5 comments:
__________________________________________
flip,
I know how to research off-line.
What did you say? I couldn't understand you by cricky!
I'm not going to reply to 1 person at a time. Too time consuming. Consider how much time I spent researching for Krebiozen, above.
Yep, we know Science picks sides from:
Galileo - the Earth is round.
Ignaz Semmelweis - wash your hands between the time you deliver a baby & do an autopsy & deliver a baby, unless you like sending people "Down Under."
Your Hyperbole is impressive!!
If you don't understand why SRB is in the position he is in today because you refuse to look at the factors that contribute to the problem ... then I can't help you. Seen any ostriches lately with their heads in the ground?
So, if you are going to criticize SRB then you should criticize tu-quack.
It's like criticizing the prison guard but not Lenin, Stalin, Hitler, or Mussolini
As usual, I guess blood has rushed to your head, being from Aussie Land, because as our former Republican American President Ronald Reagan used to say in Presidential Debates: "Well, there you go again." Libertarian? Really? You don't see my trying to state that your Political affiliation is x or y. Y? Because it's irrelevant!

By Didymus Judas Thomas (not verified) on 07 Dec 2012 #permalink

12/5 comments:
__________________________________________
flip, is that where they play '"ock-eh?
__________________________________________
Antaeus Feldspar, Really? If Lenin, Stalin, Hitler, or Mussolini were around, I guess you'd go after the prison guard.
Sadly for you, you resort to using a curse word as if that will somehow legitimize what you post, and you may try – you’ve already tried – to pretend that I'm trying to disrupt and shut down discussion of Burzynski’s wrongdoing. There’s no point in dignifying it with any other name.
You conveniently tu-quack.
See my above post to flipper.
__________________________________________
12/6 comments:
__________________________________________
MarkL, still no apology from Chris for misrepresenting what I posted?
Yawn.
I feel no compelling need to do what Chris requested when Chris can't apologize for misrepresenting what I posted. So, when people pile on after Chris, and want me to do what Chris wants, well, there's your answer!
__________________________________________
Alain, Cheerio!
__________________________________________
Science Mom, I guess being a Science Mom you would know what an acid trip is like.
__________________________________________
12/7 comments:
__________________________________________
flip, sure, the point is in the above post to MarkL.
__________________________________________
Narad, Black's Law Dictionary is impressive because the Gub-ment has gone after SRB numerous times, and if their lawyers knew how to practice law, then SRB wouldn't be where he is today if they knew how to do legal research, discovery, depositions, and present a compelling case.

By Didymus Judas Thomas (not verified) on 07 Dec 2012 #permalink

12/5 comments:
__________________________________________
flip,
ClinicalTrialsFeeds. org., Burzynski:
http:// clinicaltrialsfeeds. org/clinical-trials/results/spons=%22Burzynski+Research+Institute%22
8/20/1994 Before the Texas State Medical Board of Medical Examiners, Stanislaw R. Burzynski, M.D., Ph.D., Docket No. 503_-_92_-_529:
www. bioethicswatch. org/pd/burzynski_txorder19940831.pdf
4/18/1995 Burzynski appears before grand jury, Houston Chronical, Ruth Sorelle, Deborah Tedford, Medical Writer Staff:
www. chron. com/CDA/archives/archive.mpl/1995_1268882/burzynski-appears-before-grand-jury.html
1997 The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis, Citing Burzynski:
http:// dash.harvard. edu/bitstream/handle/1/8846812/cberry.pdf?sequence=1
6/7/2001 Inspection of clinic, Dal-DO/San Antonio Resident Post, HFD-47, Good Clinical Practice Branch II, Division of Scientific Investigations, CDER (FACTS #213702):
www. circare. org/info/bri/burzynski_fda-eir_20010810.pdf
12/20/2001 inspection of institutional review board (IRB), Dal-DO/San Antonio Resident Post, HFD-47, Good Clinical Practice Branch II, Division of Scientific Investigations, CDER:
www. circare. org/info/bri/briirb_fdaeir_20020215.pdf
1/13/2009 Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy, Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma:
www. sec. gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex99d1.htm
10/5/2009 Warning Letter, Department of Health and Human Services, Public Health Service, Food and Drug Administration:
www. fda. gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm
2/29/2012 Form 10-K, fiscal year ended:
www. sec. gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
10/18/2012 Department of Health and Human Services, Public Health Service, Food and Drug Administration, Antineoplastons A10 and AS2-1 Injections MA #1:
www. ratbags. com/rsoles/history/2012/1110fda_burzynski_2012.pdf
Cell Biology and Signaling
P.003
Burzynski:
http:// m.neuro-oncology.oxfordjournals. org/content/14/suppl_3/iii1.abstract?sid=e29ac3b0-44dc-4450-bad2-2ec944af1d24
Search results citing Burzynski (3):
http:// m.neuro-oncology.oxfordjournals. org/search/keywords/advanced?options[q]=search&options[author1]=S.%20Burzynski&options[sortspec]=date&options[submit]=Submit&options[numresults]=10&options[sortmethod]=0
11/2010 Cell Biology and Signaling:
http:// m.neuro-oncology.oxfordjournals. org/content/12/suppl_4/iv7.abstract?sid=95079a14-178f-4a13-b6dc-3fab4e9485da
11/2010 Ongoing Clinical Trials:
http:// m.neuro-oncology.oxfordjournals. org/content/12/suppl_4/iv69.abstract?sid=49e4f4d6-eaba-4841-9e7c-c156ddc51a80
9/2012 Abstracts:
http:// m.neuro-oncology.oxfordjournals. org/content/14/suppl_3/iii1.abstract?sid=95079a14-178f-4a13-b6dc-3fab4e9485da

By Didymus Judas Thomas (not verified) on 08 Dec 2012 #permalink

@DJT

The truth is out there somewhere.

And it's not likely anyone will find it hidden in your screeds.

DJT,

Cutting through your flim-flam, the only really important fact is that the great majority of the tumor was removed before Jodi started Bursynski's treatment.

Look again at the medical reports here. You appear to have seriously misunderstood what they say, so allow me to explain.

On page 2 it gives the approximate length of the tumor as seen on a CT scan as 2.2 cm.

On page 3 it gives the approximate measurements of the tumor as seen on MRI, stating that "it may have a small ring of edema", as 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm making the volume of this tumor approximately 6 cm³.

On page 5 it gives the results of proton magnetic resonance spectroscopy and approximate measurements of the tumor as 2.67 cm x 2.02 cm x 2.55 cm which I make approximately 14 cm³.

There are 3 sets of measurements from 3 different imaging techniques which broadly agree with each other.

On page 6 it refers again to the size of the tumor estimated from the MRI, which is better at estimating size than proton magnetic resonance spectroscopy which is mainly used to establish the structure and composition of tumors, not their size.

All the above diagnostic procedures appear to have been carried out on or around 05/11/00.

On page 8 it refers to the size of the biopsy sample sent to the lab on 05/15/00. Part of this was used for a frozen section which was examined during the operation, notice it refers to "intraoperative frozen section consultation". This means that part of the biopsy was frozen, sectioned and examined to provide the surgeon with information on what further action needed to be taken, during surgery while the patient is still on the table. Frozen sections are only done when further surgery may be necessary depending on the results.

Since the intraoperative consultation reports "high grade glioma" it is highly likely that further surgery was carried out and more of the tumor was removed. This is supported by the following information in Jodi's records.

On page 10 it gives the result of an MRI performed on 06/01/00 which found the volume of the tumor was 0.17 cm³.

On page 12, in a letter to Burzynski we are told that Jodi, "began antineoplaston therapy on June 6 2000". The letter also mentions a brain FDG PET scan done on June 8 2000 that was "consistent with no residual neoplasm".

To summarize the relevant information:

Pre-op tumor size by MRI on May 11 approximately 6 cm³.
Post-op tumor size by MRI on June 1 approximately 0.17 cm³.
Antineoplastons started June 6.
Tumor undetectable by PET scan on June 8.

So almost all the tumor had disappeared several days before the patient even started Burzynski's treatment, and all of it had gone two days after treatment was started. The most likely explanation is that the tumor was removed during surgery, and the residual 0.17 cm³ seen on MRI was post-op inflammation. Burzynski's treatment cannot possibly have had anything to do with this.

By Krebiozen (not verified) on 08 Dec 2012 #permalink

Diddums,

Chris merely requested that you fulfill the basic minimum requirement for arguing in support of the brave maverick - that you provide real evidence to support your argument.

Not journalistic puff-pieces, not advertising, not anecdote, REAL DATA. Strawmen, tu quoque arguments, Onus probandi, Gish gallops, Appeals to accomplishment and other logical fallacies are not going to get you any traction here either.

Burzynski is a fraud, and unless you have some hard evidence to the contrary (you don't, even Burzynski himself doesn't have that), you are a fraud too for insisting that the "brave maverick" Doctor is anything other than a snake-oil salesman.

Looking again at Jodi Fenton's medical records as presented, the only thing that makes sense is that there's a histopathology report missing. Somewhere there must be a histopathology report on the tumor that was removed after the surgeon was given the frozen section results. That report would include information on whether the tumor had clean margins or not.

Tumors don't just disappear after being biopsied, and the only reason the surgeon ordered a frozen section was to find out if the mass he or she had biopsied was malignant. As it was malignant and the surgeon was informed of this intraoperatively, he or she would surely have done his/her best to remove the tumor. Anyone with more specialized knowledge than I care to comment on this?

Also, the letter from an unnamed person at OncoImaging P.A. refers to "the series of brain MRI examinations", but also to "each of the MRI examinations" as if there were only sent two. They then refer to "the initial study in June" (my emphasis) [...] "showed two foci of enhancement. These lesions subsequently resolved, a finding consistent with a complete response to therapy".

Clearly this person was not sent the initial MRI taken on May 11 at all. They were asked to evaluate the post-op MRI taken on June 1 that showed some residual post-op inflammation, a PET scan from June 8, and a subsequent MRI that showed no mass at all. From the letter it is clear that they were not fully aware of what they were looking at, and were not shown the initial MRI that showed a 6 cm³ tumor at all. Isn't that more than a little dishonest?

By Krebiozen (not verified) on 08 Dec 2012 #permalink

Antaeus Feldspar, Really? If Lenin, Stalin, Hitler, or Mussolini were around, I guess you’d go after the prison guard.

It's obvious that it's not an either-or situation, where either you go after the dictator who's killed millions or you go after the individual perpetrator whose crimes may have shown depraved indifference to the welfare of others but whose crimes didn't affect as numerically large a group of people.

Which means it just comes right back to your premise "You shouldn’t talk about A doing wrong if B did something worse." That premise is crap, it's always been crap, and the fact that you keep trying to push that crap shows your true nature.

Sadly for you, you resort to using a curse word as if that will somehow legitimize what you post,

Actually, I'm just keeping in mind what an old friend of mine once said. He said the most devastating insult is actually "You're stupid," because the minute you start crafting a wittier, more intellectually elegant response, you're implicitly saying that the other person's nonsense requires some sort of sophisticated intellectual counter.

"A shouldn't be criticized because B is worse" does not need a sophisticated intellectual counter. It was countered millenia ago. It's bullshit plain and simple. End of story. It may be the only move you have available to you, but that's what happens when you defend a creep like Burzynski.

I think it's time for an ultimatum question; it's often the only way to deal with Gish gallopers like you.

Here's how it works: we ask you a question. If you post three comments, on this thread or any other, without giving an answer to the question, you will be treated as having answered it, in a way you probably won't like.

The question is this: Burzynski claims to be conducting clinical trials, testing out a treatment that has clinical equipoise (that is, it may or may not work or might even potentially make things worse; not knowing which it is is why we are doing trials.) If he was truly doing clinical trials, then the people who agree to be his subjects in the trials are doing him a great service, putting their precious remaining years or months of life at risk so that his treatment can be tested; they should certainly be receiving some compensation for the risk they are taking to test out his putative treatment. But as we all know, Burzynski actually charges his patients five and six figures to be in his trials; hell, you have to pay him just to get him to consider whether you'd be a suitable subject for his trials.

What possible justification can there be for Burzynski to be charging such exorbitant sums when a) the patient is the one providing something of value, b) the very fact of charging such huge amounts actually taints any data that theoretically might come out of the trials, since it excludes people who aren't rich and can't do effective fundraising from the study population?

If you don't give us your answer within your next three comments, it will be taken as you answering: "Burzynski's trials are just a ruse so that he can sell his 'treatment' without having to ever prove it works, and that's okay because Burzynski shouldn't have to follow the same rules that restrict everyone else."

By Antaeus Feldspar (not verified) on 08 Dec 2012 #permalink

MarkL:

Chris merely requested that you fulfill the basic minimum requirement for arguing in support of the brave maverick – that you provide real evidence to support your argument.

Is he still going on about me? I haven't noticed because part of ignoring the troll is to just scroll past his screeds.

I can just assume he has not posted the one Burzynski paper that shows clinical trial results that are as good as a conventional cancer treatment like Gleevec, with direct quotes clearly explaining the results. The latter being proof he actually read the paper he is citing.

I find it hilarious that the NG ad server is posting all kinds of ads for medical malpractice lawyers on this page! The ad server picks up the context of the discussion and serves up the ads it deems germane to the subject. (Like the MMS banner ads that popped up on the MMS thread, or the alkaline water machine ads I see here all the time.) Except it's ironic in this case.

I wonder how much Stan pays for malpractice insurance. Oh, right, probably nothing, as he doesn't treat or see patients based on this TMB ruling.

He will throw his own staff under the bus if push comes to shove, though. They all must carry huge coverage.

I wonder if anyone has ever tried the medical malpractice route with Stan or do his waivers protect him from liability?

By Marc Stephens … (not verified) on 08 Dec 2012 #permalink

Burzynski is a fraud,
MarkL left out the word "convicted".

By herr doktor bimler (not verified) on 08 Dec 2012 #permalink

Narad, Black’s Law Dictionary is impressive because the Gub-ment has gone after SRB numerous times, and if their lawyers knew how to practice law, then SRB wouldn’t be where he is today if they knew how to do legal research, discovery, depositions, and present a compelling case.

No, sorry. The invocation merely indicates that you are completely unable to summon a single thoughtful comment on the subject of law and probably wouldn't be able to recognize one even if it dropped out of the sky scrawled on a 16-ton weight. (Actually, given that you did it twice in one text-evacuation, "incantation" might be a better choice of words.)

@Narad

The invocation merely indicates that you are completely unable to summon a single thoughtful comment on the subject of law and probably wouldn’t be able to recognize one even if it dropped out of the sky scrawled on a 16-ton weight.

I guess his 'thoughtful' comment about the law was reserved for me, and his insightful insistence that all non-native Australians are descended from criminals.

I have a comment with an ultimatum question for Diddums; however, because I used a bad word, the comment is being held for moderation.

Just to clarify, I don't think any comments DJT may post before my comment is actually released should count towards his three. It may be hard, however, to work out exactly when the comment came out of moderation and which of DJT's fewmets came afterward.

By Antaeus Feldspar (not verified) on 08 Dec 2012 #permalink

Burzynski claims to be conducting clinical trials, testing out a treatment that has clinical equipoise

What factors would distinguish between between a physician using what they might call 'off-label medications as treatments' and a physician conducting studies and trials with the same medications on their patients? If they are using the drugs off-label, and no studies have been done to evidence their effectiveness in a given condition, what's the difference? If the physician calls them "studies", would that be relevant?

I guess his ‘thoughtful’ comment about the law was reserved for me

Nah, he tossed the same laughable posturing at Krebiozen in the same bowl of wilted word salad.

I like transposing words to make people think.

Yes, it certainly brings certain thoughts to the minds of onlookers. So does sticking pencils up one's nostrils and saying "wibble".

By herr doktor bimler (not verified) on 08 Dec 2012 #permalink

I would note that DJT abruptly switched away from Katherine Lee Bates to the Field Artillery March just as he arrived at the fruited plain.

Didymus Judas Thomas

Why did you skip the line about Brotherhood?

Orac blogs near the top:
__________________________________________
"The documentary was awful, full of biased misinformation and overall just a plain bad movie."
__________________________________________
Let's examine Orac's statement, shall we?
__________________________________________
1:44:44 - 1:44:52 of the Ducumentary displays:
"None of the oncologists who originally diagnosed each patient presented in this film would agree to go on-camera, or submit a written statement."
__________________________________________
Garden State Film Festival, New Jersey
www.app.com/article/20100321/ENT01/100320023/Garden-State-Film-Fest-mov…
__________________________________________
Newport Beach Film Festival, California
Humanitarian Vision Award 2010
http:// newportbeachfilmfest. blogspot. com/2010/04/update-burzynski-2nd-screening-added_25.html?m=1

http:// blog. bigmoviezone. com/docs/awards2010.pdf

www.kpfa.org/events/burzynski-movie-fda-big-pharma-fight-doctor-who-has…
__________________________________________
Palm Beach Film Festival
www.pbifilmfest.org/past_festivals/2010/documentaries/burzynski
__________________________________________
Winner! Audience Award Best Documentary! documentary channel, 2011
http:// blog. documentarychannel. com/post/15572363380/space-tourists-and-burzynski-cancer-is-serious

www.godlikeproductions.com/forum1/message1752221/pg1
__________________________________________
Winner! National Audience Award, HumanDoc Festival, Warsaw, Poland, 2011

Winner! Warsaw Audience Award, HumanDoc Festival, Warsaw, Poland, 2011
http://festival.humandoc.net/25?lang=en
__________________________________________
Moondance International Film Festival
Feature Documentary Film Semi-Finalist 2011
www.moondancefilmfestival.com/02_festival.winners_film.html
__________________________________________
San Luis Obispo International Film Festival, California
www.visitslo.com/cm/Releases/Release-FilmFest.html
__________________________________________
ALIVE Documentary Award, New York
https:// docs. google. com/viewer?a=v&q=cache:4TdKU8yqn4oJ:www.alivenewyork.org/uploads/1/0/3/3/10338129/aliveawardsfinal.pdf+&hl=…

By Didymus Judas Thomas (not verified) on 08 Dec 2012 #permalink

@Narad

Nah, he tossed the same laughable posturing at Krebiozen in the same bowl of wilted word salad.

Where?

@ DJT:

Seriously, do you really think that winning awards at *film festivals* is a measure of what is accurate? It has more to do with technical achievements and- possibly- audience appeal, i.e. it sells its message well. The people who judge these things are in the field: they create and work on films ( like my cousin who creates 'movie magic'), and for some awards ( audience choice), are the general public who viewed the film. It has nothing to do with science or medicine.

For example, Gary Null, who never met a pseudo-science hypothesis that he didn't like- or try to promote- has won a plethora of awards at various festivals around the world ( see his websites for a list: Gary Null.com/ Progressiveradionetwork) for his films that:
discuss the link between vaccines and autism,
deny the realtionship between hiv and aids,
promote nutrition-based cures for cancer,
frighten people away from psychiatric meds for learning disabilities and mental illness in children,
state that SBM is the cause of death in hundreds of thousands each year,
as well as other social and environmental issues, including using the difficulties of veterans, poverty and AGW as avenues for self-promotion.
NONE of his so-called scientific essays hold any water in the real world.

By Denice Walter (not verified) on 09 Dec 2012 #permalink

I forget: is DJT being *neutral* towards Burzyinski, or not? Because he does seem to be going out of his way to defend him...

Seriously, do you really think that winning awards at *film festivals* is a measure of what is accurate?

Hey, it works for Anne Dachel.

@ Narad:

Right. And as we all know, she is a paragon... of something.

By Denice Walter (not verified) on 09 Dec 2012 #permalink

It has more to do with technical achievements and- possibly- audience appeal, i.e. it sells its message well. The people who judge these things are in the field: they create and work on films

One wonders if DJT believes in the accuracy of every advertisement that won a Lion Award from the marketing industry.

By herr doktor bimler (not verified) on 09 Dec 2012 #permalink

12/7 Comments:
__________________________________________
herr doktor bimler, Bill Price has noticed as be pointed out to you, above.
__________________________________________
al kimeea, did you drop LSD like a bad habit?
__________________________________________
Krebiozen, I'm disappointed you hadn't figured out that I'm responding in order by date & even listing the date since 12/6!
Bill Price has noticed Orac's comments on other sites.
Well, it's either Orac posting elsewhere or people quoting him.
__________________________________________
flip, as Comedian Bill Engvall says: "Here's Your Sign!"
__________________________________________
JGC, because your 12/3 (6th post of that day) post & my 12/4 (8th post of that day) response to you which you had no comment for, which makes me think that you are Anonymous, since if you replied it most have been Anonymously.

I notice all these posts that say SRB does not publish, but who reads between the lines & pays attention to my post mentioned above to MarkL (right after the post to you), the 1st link re the SRB 10-K, which under:

"Table of Contents, FORWARD LOOKING STATEMENTS," mentions:

"clinical trials."

"ITEM 1, BUSINESS, General" mentions:

"currently conducting Phase II clinical trials," and further down is a section re:

Phase II Clinical Trials," "The Company began Phase II clinical studies in 1994 with 4 studies.

"At that time, a number of patients were also receiving Antineoplastons ... outside these clinical trials."

"On February 23, 1996, the FDA requested that all then-current patients of the Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to a Phase II Study, according to Protocol CAN-1."

This action resulted in the formation of 6 cohorts of patients in the CAN-1 study, with the largest group suffering from primary brain tumors.

New patients either were admitted to the CAN-1 study or have been admitted to 1 of the other studies sponsored by the Company, as appropriate.

The Company currently sponsors 1 ongoing Phase II clinical trial that is open for enrollment, which is conducted pursuant to investigational new drug applications (“INDs”) filed with the FDA & approved by an Institutional Review Board (“IRB”) designated according to federal regulations.

"All clinical trials are for the treatment of a wide variety of cancers using only a combination of Antineoplastons A10 & AS2-1."

"Most of the trials involve the use of intravenous formulations of Antineoplastons; however, a few trials use oral formulations."

"Dr. Burzynski acts as principal investigator for all clinical trials ..."

"All of the clinical trials are conducted at the Burzynski Clinic."

Each trial provides for the admission of up to 40 patients, except the CAN-1 study, in which 133 patients were enrolled.

"Please see “—Active Phase II Clinical Trials” for a list of all of these clinical trials."

Prior to approving a New Drug Application (“NDA”), the FDA requires that a drug’s safety & efficacy be demonstrated in “well-controlled” clinical trials.

Several types of controls are acceptable to the FDA. 1 of these is a “Historic Control.”

"Under a Historic Control if the course of a disease is well-known, the response of patients taking a drug can be compared to a historic group of patients with that disease who have not had medical intervention."

"For example, it is known that the tumors of patients suffering from primary malignant brain tumors (“PMBT”) will continue to grow, eventually causing the patient’s death."

If a drug is administered to a patient with PMBT & the tumors of the patient disappear or shrink significantly, an assumption is made that there has been a response to the drug.

All of the Company’s clinical trials, except 1, involve the use of Historic Controls.

"Further, all trials except the CAN-1 study are “prospective clinical trials” (“PCT”)."

A PCT is a clinical trial wherein patients are accrued into & follow the clinical trial protocol from the very beginning of the trial.

"A retrospective trial is a trial in which data from patients treated prior to the start of a clinical trial is considered. Results of retrospective trials are, in most instances, not acceptable to the FDA. "

In addition, there are no clinical trials being conducted that involve “double blind” studies & all but 1 clinical trial involve no randomization into multiple treatment groups.

"The ultimate goal of any treatment for cancer is patient survival."

"However, the FDA has determined that requiring exhaustive data showing improved patient survival may unnecessarily delay the approval of new cancer drugs."

For that reason, the FDA may grant marketing approval for a new drug product on the basis of adequate & well-controlled clinical trials establishing that the drug has an effect on a surrogate endpoint (“Milestone”) that is reasonably likely to predict clinical benefit.

"Each of the Company’s Phase II trials describes such Milestones which are used to determine success or failure of the treatment employed."

"In most of the trials, the Milestones are radiographic evidence of tumor shrinkage by X-ray, computer aided tomography or magnetic resonance imaging."

"Where appropriate, tumor markers such as Prostate Specific Antigen, blood counts, or bone marrow biopsy are used in order to assess a tumor’s growth."

Where tumor size is used as the Milestone, each clinical trial protocol that is open for enrollment describes a “complete response” as a complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks.

A “partial response” is described as at least a 50% reduction in total tumor size, with such reduction lasting at least 4 weeks.

"An “objective response” is described as either a complete or partial response for protocols BT-06, BT-08, BT-09, BT-10, BT-11, BT-12, BT-13, BT-15, BT-18, BT-21, BT-22 & BT-23."

Stable disease” is described as less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least 12 weeks.

The protocols of the Company’s clinical trials involve a 2-stage design, wherein the 1st stage proceeds until the Company admits 20 patients into the trial.

After a specified time period, if there are 0 responses by the 1st 20 patients, the trial will be discontinued & the drug declared to have less than desired activity.

If there is at least 1 response, the trial will be continued until 40 patients have been accrued. If the study continues, the following conclusions according to protocols based on 40 patients
----------------------------------------------------------
For the fiscal year ended 2/29/2012

As of 8/30/2011, the aggregate market value of the Common Stock held by non-affiliates was approximately $4,471,802, based on the last reported sales price of the Registrant’s most recently completed 2nd fiscal quarter. For purposes of this disclosure, shares of Common Stock held by persons who hold more than 5% of the outstanding shares of common stock & shares held by officers & directors of the registrant have been excluded as such persons may be deemed to be affiliates.

As of 5/ 1/2012, there were 131,448,444 shares of the Registrant’s Common Stock outstanding.
----------------------------------------------------------
"FORWARD LOOKING STATEMENTS"

This report contains forward-looking statements, including statements regarding future financial performance & results &other statements that are not historical facts. Such statements are included in “Business,” “Management’s Discussion & Analysis of Financial Condition & Results of Operations” & elsewhere in this report. When used in this report, words such as “may,” “will,” “should,” “could,” “anticipate,” “believe,” “expect,” “estimate,” “intend,” “plan,” “predict,” “potential,” “continue” & similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, & Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, there can be no assurance that actual results or developments anticipated by the Company will be realized or, even if realized, that they will have the expected effects on its business or operations. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors beyond the Company’s control including: the ability to develop safe & efficacious drugs, the failure to achieve positive clinical trials, the failure to successfully commercialize our products, competition & technological change existing and future regulations affecting our business.
----------------------------------------------------------
1. BUSINESS

General

Burzynski Research Institute, Inc. was incorporated under the laws of the State of Delaware in 1984 in order to engage in the research, production, marketing, promotion & sale of certain medical chemical compounds composed of growth-inhibiting peptides, amino & derivatives & organic acids which are known under the trade name “Antineoplastons.” The Company believes Antineoplastons are useful in the treatment of human cancer & is currently conducting Phase II clinical trials of Antineoplastons relating to the treatment of cancer. Antineoplastons have not been approved for sale or use by the Food and Drug Administration of the US Department of Health &Human Services (“FDA”) or anywhere in the world. In the event Antineoplastons receive such approval & are registered in the US, Canada, or Mexico, of which there can be no assurance, the Company will commence commercial operations, which shall include the production, marketing, promotion & sale of Antineoplastons in the US, Canada, or Mexico. In 2004, the FDA approved the designation of Antineoplastons as an “orphan drug” under the Orphan Drug Act of 1983. See “Orphan Drug Designation” below for a detailed description of this designation & its meaning. The Company currently provides Antineoplastons solely for use by Stanislaw R. Burzynski, M.D., Ph.D. (“Dr. Burzynski”) in clinical research.

The Company has not generated any significant operating revenue since its inception. The Company’s sole source of funding for its operations has been & continues to be payments made by Dr. Burzynski from funds generated from Dr. Burzynski’s medical practice pursuant to various arrangements between the Company & Dr. Burzynski. See “Certain Relationships & Related Transactions, & Director Independence.” The Company reports funds pursuant to such arrangements as additional paid-in capital. See “Management’s Discussion & Analysis of Financial Condition & Results of Operations.” The Company does not expect to generate significant operating revenue until such time, if any, as Antineoplastons are approved for use & sale by the FDA. However, the Company may seek additional funding for operations through the sale of its securities.
**********************************************************************
Antineoplastons

Dr. Burzynski commenced his cancer research in 1967 focusing on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer. In the course of his research, Dr. Burzynski identified certain peptides, amino acid derivatives & organic acids in these biochemicals which appear to inhibit the growth of cancer cells. These derivatives were given the name “Antineoplastons” by Dr. Burzynski.

Antineoplastons are found in the bodily fluids of humans & food & were initially isolated by Dr. Burzynski from normal human blood & urine. Dr. Burzynski believes these substances counteract the development of cancerous growth through a biochemical process which does not inhibit the growth of normal tissues. To date, Dr. Burzynski has developed 6 formulations of natural Antineoplastons & 6 synthetic formulations of Antineoplastons. All of the Phase II clinical trials currently sponsored by the Company involve the use of 4 formulations of synthetic Antineoplastons known as A10 & AS2-1 in capsules & injections. The Company is also conducting laboratory research involving new generations of Antineoplastons A10 & AS2-1.
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Orphan Drug Designation

On 9/3/2004, the FDA granted the Company’s request for “orphan drug designation” (“ODD”) for the Company’s Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment for patients with brain stem glioma &, on 10/30/2008, the FDA granted the Company’s request for ODD for Antineoplastons (A10 & AS2-1 Antineoplaston) for the treatment of gliomas. In enacting the Orphan Drug Act of 1983, Congress sought to provide incentives to promote the development of drugs for the treatment of rare diseases. A drug may be considered for orphan drug designation if the drug is intended to treat a rare disease or condition affecting fewer than 200,000 people in the US or, even if the drug treats a disease affecting more than 200,000 people in the US, the drug is not expected to be profitable from sales in the US. Subject to applicable laws & regulations, the first sponsor to obtain FDA marketing approval for a drug with orphan drug designation for the designated disease or condition receives limited marketing exclusivity for 7 years; no other sponsor may bring to market the “same drug” for the treatment of the same disease or condition for a period of 7years from the date the application is approved by the FDA. A drug with orphan drug designation must meet the same criteria for safety & efficacy as a drug without orphan drug designation.

Please see “Government Regulation” for a description of the regulatory approval process with the FDA & other regulatory agencies.
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Phase II Clinical Trials

The Company began Phase II clinical studies in 1994 with 4 studies. At that time, a number of patients were also receiving Antineoplastons at Dr. Burzynski’s clinic ... outside these clinical trials. On 2/23/1996, the FDA requested that all then-current patients of the Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to a Phase II Study, according to Protocol CAN-1. This action resulted in the formation of 6 cohorts of patients in the CAN-1 study, with the largest group suffering from primary brain tumors. New patients either were admitted to the CAN-1 study or have been admitted to 1 of the other studies sponsored by the Company, as appropriate.

The Company currently sponsors one ongoing Phase II clinical trial that is open for enrollment, which is conducted pursuant to investigational new drug applications (“INDs”) filed with the FDA & approved by an Institutional Review Board (“IRB”) designated according to federal regulations.

All clinical trials are for the treatment of a wide variety of cancers using only a combination of Antineoplastons A10 & AS2-1. Most of the trials involve the use of intravenous formulations of Antineoplastons; however, a few trials use oral formulations. Dr. Burzynski acts as principal investigator for all clinical trials pursuant to a Royalty Agreement between the Company & Dr. Burzynski. See “Certain Relationships &Related Transactions, & Director Independence.” All of the clinical trials are conducted at the Burzynski Clinic. Each trial provides for the admission of up to 40 patients, except the CAN-1 study, in which 133 patients were enrolled. Please see “—Active Phase II Clinical Trials” for a list of all of these clinical trials.

Prior to approving a New Drug Application (“NDA”), the FDA requires that a drug’s safety & efficacy be demonstrated in “well-controlled” clinical trials. Several types of controls are acceptable to the FDA. One of these is a “Historic Control.” Under a Historic Control if the course of a disease is well-known, the response of patients taking a drug can be compared to a historic group of patients with that disease who have not had medical intervention. For example, it is known that the tumors of patients suffering from primary malignant brain tumors (“PMBT”) will continue to grow, eventually causing the patient’s death. If a drug is administered to a patient with PMBT &the tumors of the patient disappear or shrink significantly, an assumption is made that there has been a response to the drug.

All of the Company’s clinical trials, except 1, involve the use of Historic Controls. Further, all trials except the CAN-1 study are “prospective clinical trials” (“PCT”). A PCT is a clinical trial wherein patients are accrued into & follow the clinical trial protocol from the very beginning of the trial. A retrospective trial is a trial in which data from patients treated prior to the start of a clinical trial is considered. Results of retrospective trials are, in most instances, not acceptable to the FDA. In addition, there are no clinical trials being conducted that involve “double blind” studies & all but one clinical trial involve no randomization into multiple treatment groups.

The ultimate goal of any treatment for cancer is patient survival. However, the FDA has determined that requiring exhaustive data showing improved patient survival may unnecessarily delay the approval of new cancer drugs. For that reason, the FDA may grant marketing approval for a new drug product on the basis of adequate & well-controlled clinical trials establishing that the drug has an effect on a surrogate endpoint (“Milestone”) that is reasonably likely to predict clinical benefit. Each of the Company’s Phase II trials describes such Milestones which are used to determine success or failure of the treatment employed. In most of the trials, the Milestones are radiographic evidence of tumor shrinkage by X-ray, computer aided tomography or magnetic resonance imaging. Where appropriate, tumor markers such as Prostate Specific Antigen, blood counts, or bone marrow biopsy are used in order to assess a tumor’s growth.

Where tumor size is used as the Milestone, each clinical trial protocol that is open for enrollment describes a “complete response” as a complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks. A “partial response” is described as at least a 50% reduction in total tumor size, with such reduction lasting at least 4 weeks. An “objective response” is described as either a complete or partial response for protocols BT-06, BT-08, BT-09, BT-10, BT-11, BT-12, BT-13, BT-15, BT-18, BT-21, BT-22 and BT-23. “Stable disease” is described as less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least 12 weeks.

The protocols of the Company’s clinical trials involve a 2-stage design, wherein the 1st stage proceeds until the Company admits 20 patients into the trial. After a specified time period, if there are 0 responses by the 1st 20 patients, the trial will be discontinued & the drug declared to have less than desired activity. If there is at least 1 response, the trial will be continued until 40 patients have been accrued. If the study continues, the following conclusions according to protocols based on 40 patients can be made: If there are 3 or fewer responses, then there is less than desired activity. If there are 4 or more responses, then there is sufficient evidence to conclude that the Antineoplaston regimen used shows beneficial activity.
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Certain prospective protocols which have reached a Milestone as of 5/1/2012:

· Protocol BT-06, involving the study of Antineoplastons A10 & AS2-1 in children with high grade glioma.

· Protocol BT-07, involving the study of Antineoplastons A10 & AS2-1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy.

· Protocol BT-08, involving the study of Antineoplastons A10 & AS2-1 in patients with anaplastic astrocytoma.

· Protocol BT-09, involving the study of Antineoplastons A10 & AS2-1 in patients with brain tumors.

· Protocol BT-10, involving the study of Antineoplastons A10 & AS2-1 in children with brain tumors.

· Protocol BT-11, involving the study of Antineoplastons A10 & AS2-1 in patients with brainstem glioma.

· Protocol BT-12, involving the study of Antineoplastons A10 & AS2-1 in children with primitive neuroectodermal tumors (PNET).

· Protocol BT-13, involving the study of Antineoplastons A10 & AS2-1 in children with low grade astrocytoma, a type of PMBT.

· Protocol BT-15, involving the study of Antineoplastons A10 & AS2-1 in adult patients with anaplastic astrocytoma, a type of PMBT.

· Protocol BT-18, involving a study of Antineoplastons A10 & AS2-1 in the treatment of “mixed glioma,” a type of PMBT.

· Protocol BT-20, involving the study of Antineoplastons A10 & AS2-1 in patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy.

· Protocol BT-21, involving the study of Antineoplastons A10 & AS2-1 in adults with primary malignant brain tumors.

· Protocol BT-22, involving a study of Antineoplastons A10 & AS2-1 in children with primary malignant brain tumors.

· Protocol BT-23, involving a study of Antineoplastons A10 & AS2-1 in children with visual pathway glioma.
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The results of Protocols BT-06, BT-07, BT-08, BT-09, BT-10, BT-11, BT-12, BT-13, BT-15, BT-18, BT-20, BT-21, BT-22 and BT-23 are set forth below (as of 5/1/2012).

Protocol # / Patients Accrued / Evaluable Patients / # &% of Patients Showing Complete Response / # & % of Patients Showing Partial Response / # & % of Patients Showing Stable Disease / # & % of Patients Showing Progressive Disease

BT-06 / 19 / 11 / 1 / 9.1% / 3 / 27.3% / 3 / 27.3% / 4 / 36.4%
BT-07 / 40 / 24 / 2 / 8.3% / 1 / 4.2% / 3 / 12.5% / 18 / 75.0%
BT-08 / 19 / 14 / 4 / 28.6% / 0 / 0.0% / 6 / 42.9% / 4 / 28.6%
BT-09 / 40 / 28 / 4 / 14.3% / 5 / 17.9% / 13 / 46.4% / 6 / 21.4%
BT-10 / 30 / 22 / 3 / 13.6% / 1 / 4.5% / 7 / 31.8% / 11 / 50.0%
BT-11 / 40 / 28 / 5 / 17.9% / 4 / 14.3% / 12 /42.9% / 7 / 25.0%
BT-12 / 13 / 11 / 3 / 27.3% / 1 / 9.1% / 3 / 27.3% / 4 / 36.4%
BT-13 / 17 / 14 / 6 / 42.9% / 1 / 7.1% / 5 / 35.7% / 2 / 14.3%
BT-15 / 27 / 20 / 3 / 15.0% / 2 / 10.0% / 9 / 45.0% / 6 / 30.0%
BT-18 / 20 / 13 / 3 / 23.1% / 1 / 7.7% / 3 / 23.1% / 6 / 46.2%
BT-20 / 40 / 22 / 1 / 4.5% / 1 / 4.5% / 12 / 54.5% / 8 / 36.4%
BT-21 / 40 / 23 / 2 / 8.7% / 2 / 8.7% / 9 /
39.1% / 10 / 43.5%
BT-22 / 40 / 24 / 1 / 4.2% /3 / 12.5% / 9 / 37.5% / 11 / 45.8%
BT-23 / 16 / 12 / 3 / 25% / 2 / 16.7% / 6 / 50.0% / 1 / 8.3%
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The Phase II Study according to Protocol CAN-1 included 35 evaluable brain tumor patients. Complete & partial responses were obtained in patients diagnosed with glioblastoma multiforme, astrocytoma, oligodendroglioma, mixed glioma, medulloblastoma, & malignant meningioma. The treatment with Antineoplastons A10 & AS2-1 resulted in 48.6% cases of objective responses & 31.4% cases of stable disease. The largest group of evaluable patients involved in the study had glioblastoma multiforme. 6 of the cases were classified as complete & partial responses, 4 obtained stabilization & 4 developed progression of the disease.

Notwithstanding the response results of the trials that have reached a Milestone, management believes it is likely that the FDA may require additional clinical trials based upon such protocols to be conducted by an institution not affiliated with the Company or Dr. Burzynski before advising that an NDA filing is warranted. In addition, the FDA has indicated it will not accept the efficacy data, but will accept toxicity data generated by the Phase II study according to Protocol CAN-1 because the trial was partially retrospective. At this time, the Company cannot predict if and/or when it will submit an NDA to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require. Further, there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.

No assurance can be given that any new IND for clinical tests on humans will be approved by the FDA for human clinical trials on cancer or other diseases, that the results of such human clinical trials will prove that Antineoplastons are safe or effective in the treatment of cancer or other diseases, or that the FDA would approve the sale of Antineoplastons in the US.
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Open for Enrollment Phase II Clinical Trials

The following table sets forth the title of each active Protocol & the # of persons currently enrolled in each study. All of the following trials are Phase II studies &, except as otherwise indicated, are of Antineoplastons A10 & AS2-1 in patients with the conditions listed. For purposes of this table, active means that the study is still under open enrollment. In addition, all of the studies listed have a maximum of 40 patients who may ultimately participate in the study. The information in this table is updated as of 5/1/2012.

Title of Protocol / Subject of Protocol / # of Persons Enrolled / BT-10 / Children with Brain Tumors / 30
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Phase III Clinical Trials

On 1/13/2009, the Company announced that it has reached an agreement with the FDA that enables the Company to move forward immediately with a pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma. The agreement was made under the FDA’s Special Protocol Assessment procedure & means that the design & planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval.

On 2/23/2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint (“Research Point”) to initiate & manage a pivotal Phase III clinical trial of combination Antineoplastons A10 & AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma. Research Point has secured interest & commitments from a # of sites selected. Upon completion of this assessment, a randomized, international Phase III study will commence. The study’s objective is to compare overall survival of children with newly-diagnosed, diffuse, intrinsic brainstem glioma (DBSG) who receive combination Antineoplastons A10 & AS2-1 plus RT versus RT alone.
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Government Regulation

The FDA imposes substantial requirements upon, & conditions precedent to, the introduction of therapeutic drug products to the marketplace. Seeking marketing authorization for a new drug is a lengthy, complex, & costly process. To seek FDA approval for Antineoplastons, we must first complete extensive preclinical & clinical research, & submit data from this research & supporting information to the FDA to demonstrate that the use of Antineoplastons for the indication sought meets the statutory standards for safety & effectiveness, manufacturing & controls, & labeling.

The approval process takes many years, requires the expenditure of substantial resources & may involve ongoing requirements for post-marketing studies. Additional government regulation may be established that could prevent or delay regulatory approval of Antineoplastons. Moreover, there can be no assurance that the Company can satisfy FDA requirements to gain approval for Antineoplastons in the US or that FDA approval for the sale of Antineoplastons in the US will be obtained. If regulatory approval is granted, the approval may include significant limitations on the indicated uses for which Antineoplastons may be marketed.

The effect of the FDA drug approval process for Antineoplastons may impose costly procedures upon the Company’s activities which may furnish a competitive advantage to the other companies that compete with the Company in the field of cancer treatment drugs. The extent of potentially adverse government regulations which might arise from future legislation or administrative action cannot be predicted.

The Investigational New Drug Application Process in the US is governed by regulations established by the FDA which strictly control the use & distribution of investigational drugs in the US. The guidelines require that an IND, filed by a sponsor, contain sufficient information to justify administering the drug to humans, that the application include relevant information on the chemistry, pharmacology & toxicology of the drug derived from chemical, laboratory & animal or in vitro testing, & that a protocol be provided for the initial study of the new drug to be conducted on humans.

In order to conduct a clinical trial of a new drug in humans, a sponsor must prepare & submit to the FDA a comprehensive IND. Such application must contain an investigator’s brochure, a description of the composition, manufacture & control of the drug substance & the drug product, sufficient information to assure the proper identification, quality, purity & strength of the investigational drug, a description of the drug substance, including its physical, chemical, & biological characteristics, the general method of preparation of the drug substance, a list of all components including interactive ingredients, adequate information about pharmacological & toxicological studies of the drug involving laboratory animals or in vitro tests on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigation & a summary of any previous human experience with the drug. Where there has been widespread use of the drug outside of the US or otherwise, it is possible in some limited circumstances to use well-documented clinical experience in place of some other pre-clinical work.

The focal point of the IND is on the general investigational plan & the protocols for specific human studies. The sponsor of the study is subject to numerous requirements for the proper conduct & oversight of the study, including the protection of human subjects. The plan is carried out in 3 phases, & earlier phase trials are not necessarily predictive of results in later clinical trials. Phase I includes the initial introduction of an investigational new drug into humans & may be conducted in patients or normal volunteer subjects. The studies are closely monitored to determine the metabolism & pharmacologic actions of the drug in humans, the potential side effects &, if possible, to gain early evidence on effectiveness. During Phase I testing, sufficient information about the drug is gathered to design well-controlled, scientifically valid Phase II studies. Phase II includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study & to determine the common short-term side effects & risks associated with the drug. Phase II studies are controlled, closely monitored & conducted in a relatively small # of patients, usually involving no more than several 100 subjects. Phase III includes expanded controlled & uncontrolled trials & are intended to gather the additional information about effectiveness & safety that is needed to evaluate the overall benefit-risk relationship of the drug & to provide an adequate basis for physician labeling. Phase III studies usually include anywhere from several 100 to several 1,000 subjects.

An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns about issues such as the conduct of the trials as outlined in the IND. After the IND becomes effective, the investigation is permitted to proceed, during which the sponsor must keep the FDA informed of new studies, including animal studies, make progress reports on the study or studies covered by the IND, and also be responsible for informing FDA & clinical investigators immediately of unforeseen serious side effects or injuries. There can be no assurance that Phase I, Phase II or Phase III testing will be completed successfully by the Company within any specified period of time, if at all. Furthermore, the Company or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

Assuming successful completion of the clinical studies, the results of the studies, together with other detailed information, including, among other information, details concerning the manufacture & composition of the drug, proposed labeling, environmental impact & the scientific rationale for the drug, its intended use & the potential benefits of the drug product, are submitted to the FDA in the form of an NDA requesting approval to market the drug. If the FDA finds the NDA submission & the manufacturing process to be acceptable & to meet the criteria for approval, the FDA will issue an approval letter. If the FDA determines that an NDA cannot be approved as submitted, it will send the applicant a “Complete Response” letter to indicate that the review cycle for an application is complete & that the application is not ready for approval, & describing specific deficiencies. In addition to the postmarketing requirements that apply to all marketed drugs, FDA may impose, as a condition of approval, postmarketing requirements such as postmarketing study commitments, or other limitations or restrictions. Product approvals may be withdrawn by FDA, following notice of opportunity for a hearing, if problems concerning safety or efficacy of a drug or the sponsor’s compliance with regulatory requirements.

The Company’s use of Milestones to predict the benefits of Antineoplastons is relevant to the FDA approval process. If surrogate endpoints are used, for regular approval (i.e., the longstanding FDA route of drug approval based on the demonstration of clinical benefit) an applicant must show direct evidence of clinical benefit or improvement in an established surrogate for clinical benefit. For “accelerated approval,” a process potentially available for pharmaceutical agents that treat serious or life-threatening disease & conditions, surrogate endpoints must be reasonably likely to predict clinical benefit. When appropriate, the Company intends to pursue opportunities for accelerated review of its products. The Company cannot predict the ultimate effect of this review process on the timing or likelihood of FDA review of any of its products. Adequacy as a surrogate endpoint for regular or accelerated approval is highly dependent upon a variety of factors including effect size, effect duration, & benefits of other available therapy.

A drug’s approval under the accelerated approval regulations is conditioned on the conduct of postapproval clinical studies to verify & describe the actual clinical benefit. Further, the FDA may also impose post-marketing restrictions to assure safe use of a drug product that was subject to accelerated approval. For drugs approved under FDA’s accelerated procedures, the FDA may withdraw approval of the drug on an expedited basis if the applicant fails to perform the required postmarketing study with due diligence, use of the drugs demonstrates that post-marketing restrictions are inadequate to assure safe use of the drug, the applicant fails to adhere to the post-marketing restrictions agreed upon, the promotional materials are false or misleading, or other evidence demonstrates that the drug is not shown to be safe or effective under its conditions of use.

The testing & approval process requires substantial time, effort & financial resources, & there can be no assurance that any approval will be granted for any product or that approval will be granted according to any schedule. Moreover, if regulatory approval of a drug is granted, the approval will be limited to specific indications. There can be no assurance that any of the Company’s product candidates will receive regulatory approvals for commercialization.

Please see “Orphan Drug Designation” for a description of the FDA’s orphan drug designation under the Orphan Drug Act of 1983 as it applies to the Company’s Antineoplastons.

Even if the regulatory approvals for the Company’s products are obtained, its products & its manufacturing facility are subject to ongoing compliance obligations.. The FDA will require post-marketing monitoring & reporting related to the safety of the Company’s products. The Company’s drug manufacturing facility, & the facility of any 3rd-party contracted to manufacture the products, must comply with the FDA’s current good manufacturing practice (GMP) regulations, which are strictly enforced. Manufacturing facilities will be subject to periodic inspection by FDA. Full technical compliance requires manufacturers to expend funds, time & effort in the area of production & quality control. In addition, discovery of problems with a product after approval or failure to comply with applicable FDA or other applicable regulatory requirements may result in enforcement actions & restrictions on a product, manufacturer, or holder of an approved NDA, including restrictions on the product, manufacturer or facility, including warning letters, suspension of regulatory approvals, operating restrictions, delays in obtaining new product approvals, withdrawal of the product from the market, product recalls, fines, injunctions & criminal prosecution. New government requirements may be established that could delay or prevent regulatory approval of the Company’s products under development or impose additional compliance obligations before or after approval.

The Company’s research & development involves the controlled use of hazardous materials, chemicals & various radioactive compounds. Although the Company believes its procedures for handling & disposing of those materials comply with state & federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. If an accident of this type occurs, the Company could be held liable for resulting damages, which could be material to its financial condition & business. The Company is also subject to numerous environmental, health & workplace safety laws & regulations, including those governing laboratory procedures & the handling of biohazardous materials. Additional federal, state & local laws & regulations affecting the Company may be adopted in the future. Any violation of these laws & regulations, &the cost of compliance, could materially & adversely affect the Company. The Company has historically spent approximately $40,000 per year on environmental compliance matters. For the year ended 2/29/2012, the Company spent approximately $66,000 on environmental compliance matters due to increased production of Antineoplastons. The Company expects to spend approximately $5,000 for repairs & upgrades during the fiscal year ending 2.28/2013.
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Research And Development

The Company’s principal research & development efforts currently focus on Antineoplastons. The anticancer activity of these compounds has been documented in preclinical studies employing the methods of cell culture, pharmacology, cell biology, molecular biology, experimental therapeutics & animal models of cancer. At the level of Phase II clinical studies, the Company believes the anticancer activity of Antineoplastons is supported by preliminary results from ongoing, FDA-authorized, Phase II clinical trials.

The cellular mechanism underlying the anticancer effects of Antineoplastons continues to be investigated in both the Company’s own basic preclinical research program & in independent laboratories around the world. A review of this work suggests several mechanisms that may underlie the antineoplastic activity of Antineoplastons. For example, it has been found, in cell culture experiments, that Antineoplastons induce pathologically undifferentiated cancer cells to assume a more normal state of differentiation. Cell culture experiments have also shown that Antineoplaston components can kill some cancer cells by activating the cell’s intrinsic “suicide” program. It must be noted that data collected in cell culture experiments may or may not indicate the mechanism of action of Antineoplastons in humans.

At a more molecular or sub-cellular level, cell culture experiments have shown that Antineoplastons can block biochemical pathways involving oncogenes required to produce abnormal cell growth. In addition, cell culture experiments have shown that Antineoplastons can increase the expression of anticancer tumor suppressor genes. Although these experiments were conducted using human cancer cells, they may or may not indicate the mechanism of Antineoplaston action in humans.

In addition to the original family of Antineoplaston compounds (the “Parental Generation”), the Company continues its development of a 2nd generation of Antineoplastons. In cell culture experiments, the 2nd generation Antineoplastons, which were developed by the Company, have been shown to be significantly more potent than the Parental Generation.

The Company is also developing a 3rd generation of structurally altered Antineoplastons that the Company believes will exhibit markedly improved anticancer activity in human cancer cell lines that have been resistant to the Parental Generation. However, increases of antineoplastic activity in cell culture experiments may or may not translate into increased efficacy in humans.

The Company is also involved in ongoing studies examining the pharmacokinetics (absorption, distribution, metabolism, & excretion) & pharmacodynamics (dose-response) of Antineoplastons in patients with neoplastic disease.

The Company uses various scientific reagents from several different suppliers to conduct its research activities.

Total research & development costs for the fiscal years ended 2/29/2012 and 2/28/2011 were approximately $6,926,000 & $4,780,000, respectively.
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Intellectual Property

Since 1984, 8 patents involving the formulation, preparation, manufacture, production, use, dosage & treatment of cancer with Antineoplastons (the “Patents”) have been issued to Dr. Burzynski by the US Patent Office & the Patent Offices of 34 other countries. The Patents for cancer treatment & diagnosis in the US & Canada are licensed to the Company pursuant to a License Agreement dated 6/29/1983, as superseded by an Amended License Agreement dated 4/24/1989 and a 2nd Amended License Agreement dated 3/1/1990 (collectively, the “License Agreement”). Pursuant to the License Agreement, the Company holds an exclusive right in the US, Canada, & Mexico (the “Territory”) to use, manufacture, develop, sell, distribute, sub-license & otherwise exploit all of Dr. Burzynski’s rights, title, & interests, including patent rights, in Antineoplastons in the treatment & diagnosis of cancer. See “Certain Relationships & Related Transactions, & Director Independence.” The Company will not be able to exploit such rights until such time as Antineoplastons are approved, of which there can be no assurance, by the FDA for sale in the US. The License Agreement is to continue in effect until the expiration of the last Patent that was licensed under the agreement or termination pursuant to certain other provisions. The Company & Dr. Burzynski also entered into a Royalty Agreement, dated 3/25/1997, & a 1st Amended Royalty Agreement, dated 9/29/1997 (collectively, the “Royalty Agreement”), pursuant to which Dr. Burzynski will receive a royalty interest from all future sales, distribution, & manufacture of Antineoplastons by the Company. The Company owns, pursuant to the License Agreement, exclusive rights to eight issued US Patents, 4 issued Canadian Patents & 1 issued Mexican Patent.

The 5 initial US Patents (the “Initial Patents”) relate to: (i) Determination of Antineoplastons in body tissue or fluids as a testing procedure to aid in the diagnosis of cancer; (ii) Processes for the preparation of purified fractions of Antineoplastons from human urine; (iii) Processes for the synthetic production of Antineoplastons & methods of treating neoplastic disease (cancer); (iv) Administration of Antineoplastons to humans; & (v) Methods of synthesizing A-10. The last of the Initial Patents expired on 1/11/2009, however, the Company does not believe the expiration of any of the Initial Patents will have a material adverse effect on the Company.

The 6th US Patent (the “2000 U.S. Patent”) covers Liposomal Antineoplaston therapies with markedly improved anti-cancer activity. The 2000 U.S. Patent expires on 5.14/2017.

The 7th US Patent (the “2001 U.S. Patent”) is for a treatment regimen for the administration of phenylacetylglutamine, phenylacetylisoglutamine, and/or phenylacetate. The 2001 U.S. Patent expires on 7.23/2018.

The 8th US Patent (the “2005 U.S. Patent”) relates to a divisional application to the 2001 U.S. Patent. The 2005 U.S. Patent issued in September 2005 & will expire 7.31/2018.

The 4 Canadian Patents (the “Canadian Patents”) relate to: (i) Processes for the preparation of purified fractions of Antineoplastons from human urine, (ii) Processes for the synthetic production of Antineoplastons & methods of treating neoplastic disease (cancer), (iii) Liposomal formulation of Antineoplastons & (iv) Treatment regimen for the administration of phenylacetylglutamine. The Canadian Patents expired or will expire on 6/4/2002, 11/14/2006, 5 .14/2017 & 7 .2/2019, respectively; however, the Company does not believe the expiration of the Canadian Patents will have a material adverse effect on the Company.

The Mexican Patent relates to a treatment regimen for the administration of phenylacetylglutamine. This patent will expire in the year 2019.

The Company also depends upon unpatented proprietary technology, & may determine in appropriate circumstances that its interest would be better served by reliance upon trade secrets or confidentiality agreements rather than patents.

The Company’s success will depend in part on its ability to enforce patent protection for its products, preserve its trade secrets, & operate without infringing on the proprietary rights of 3rd parties in the US, Canada, & Mexico. Because of the substantial length of time & expense associated with bringing new products through development & regulatory approval to the marketplace, the pharmaceutical & biotechnology industries place considerable importance on obtaining & maintaining patent & trade secret protection for new technologies, products & processes. There can be no assurance that the Company will develop additional products & methods that are patentable or that present or future patents will provide sufficient protection to the Company’s present or future technologies, products & processes. In addition, there can be no assurance that others will not independently develop substantially equivalent proprietary information, design around the Company’s patents or obtain access to the Company’s know-how or that others will not successfully challenge the validity of the Company’s patents or be issued patents which may prevent the sale of one or more of the Company’s product candidates, or require licensing & the payment of significant fees or royalties by the Company to 3rd parties in order to enable the Company to conduct its business. Legal standards relating to the scope of claims & the validity of patents in the fields in which the Company is pursuing research & development are still evolving, are highly uncertain & involve complex legal & factual issues. No assurance can be given as to the degree of protection or competitive advantage any patents issued to the Company will afford, the validity of any such patents or the Company’s ability to avoid violating or infringing any patents issued to others. Further, there can be no guarantee that any patents issued to or licensed by the Company will not be infringed by the products of others. Litigation & other proceedings involving the defense & prosecution of patent claims can be expensive & time-consuming, even in those instances in which the outcome is favorable to the Company, & can result in the diversion of resources from the Company’s other activities. An adverse outcome could subject the Company to significant liabilities to 3rd parties, require the Company to obtain licenses from 3rd parties or require the Company to cease any related research & development activities or sales.

The Company depends upon the knowledge, experience & skills (which are not patentable) of its key scientific & technical personnel. To protect its rights to its proprietary information, the Company requires all employees, consultants, advisors & collaborators to enter into confidentiality agreements which prohibit the disclosure of confidential information to anyone outside the Company & require disclosure & assignment to the Company of their ideas, developments, discoveries & inventions. There can be no assurance that these agreements will effectively prevent the unauthorized use or disclosure of the Company’s confidential information.

ANTINEOPLASTON® is a trademark registered with the U.S. Patent & Trademark Office.
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Competition

There are many companies, universities, research teams & scientists, both private & government-sponsored, that are engaged in research to produce cancer treatment agents & that have greater financial resources & larger research staffs & facilities than the Company. In addition, there are other companies & entities, both private & government-sponsored, that are engaged in research aimed at compounds similar or related to the Company’s Antineoplastons. To the extent that the US
Government also conducts research or supports other companies or individuals in their research, such companies or individuals may have a competitive advantage over the Company.
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Employees

As of 5/1/2012, the Company had 3 employees, all of whom were full-time employees. None of the Company’s employees are parties to a collective bargaining agreement. The Company considers the relations with its employees to be good.
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2. PROPERTIES

The Company does not own or invest in real estate, interests in real estate, real estate mortgages or securities of or interests in persons primarily engaged in real estate activities.

The Company conducts its business in premises owned by Dr. Burzynski & his wife, Dr. Barbara Burzynski (the “Burzynskis”). Pursuant to arrangements with the Burzynskis (see “Certain Relationships & Related Transactions, & Director Independence—Research Funding Arrangements”), the Company occupies (i) 675 square feet for office, laboratory & medical research purposes & (ii) 540 square feet for its executive offices. Management of the Company believes that each of these properties is adequately covered by insurance.
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3. LEGAL PROCEEDINGS

The Company’s activities are subject to regulation by various governmental agencies, including the FDA, which regularly monitor the Company’s operations & often impose requirements on the conduct of its clinical trials and other aspects of the Company’s business operations. The Company’s policy is to comply with all such regulatory requirements. From time to time, the Company is also subject to potential claims by patients & other potential claimants commonly arising out of the operation of a medical practice. The Company seeks to minimize its exposure to claims of this type wherever possible.

Currently, the Company is not a party to any material pending legal proceedings. Moreover, the Company is not aware of any such legal proceedings that are contemplated by governmental authorities with respect to the Company or any of its properties.
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5. MARKET FOR REGISTRANT’S COMMON EQUITY; RELATED STOCKHOLDER MATTERS & ISSUER PURCHASES OF EQUITY SECURITIES

Since 9/15/2001, the Company’s Common Stock has remained in good standing for trading on the OTCBB. Nevertheless, a public trading market having the characteristics of depth, liquidity & orderliness depends upon the existence of market makers as well as the presence of willing buyers & sellers, which are circumstances over which the Company does not have control. There can be no assurance that the market will provide significant liquidity for the Company’s Common Stock. As a result, an investment in the Company’s Common Stock may be highly illiquid. Investors may not be able to sell their shares readily or at all when the investor needs or desires to sell.

The following table sets forth closing high & low bid prices of the shares of Common Stock of the Company for the periods indicated (as reported by OTC Markets Group Inc.).
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Price Range
High / Low

Fiscal year ended 2/28/2011
1st Quarter
$0.22 / $0.11

2nd Quarter
0.17 / 0.08

3rd Quarter
0.15 / 0.08

4th Quarter
0.15 / 0.11

Fiscal year ended 2/29/2012
1st Quarter
$0.15 / $0.08

2nd Quarter
0.19 / 0.05

3rd Quarter
0.42 / 0.12

4th Quarter
0.28 /0.22

The quotations set forth above reflect inter-dealer prices, without retail mark-up, mark-down or commission, & may not represent actual transactions.

On 6/1/2009, the Company approved the issuance of 60,000 shares of the Company’s Common Stock as compensation for services rendered to the Company & were fair valued at approximately $9,400. The shares were sold pursuant to an exemption from registration under Section 4(2) of the Securities Act of 1933, as amended, to a single accredited investor & did not involve a public offering, & were issued to such investor on 6/2/2010.

As of 5/1/2012, there were approximately 2,000 holders of record of the Company’s Common Stock, as shown on the records of the Transfer Agent & Registrar of the Common Stock. Since many shares may be held by investors in nominee names, such as the name of their broker or their broker’s nominee, the # of record holders often bears little relationship to the # of beneficial owners of the Common Stock.

The Company has never paid cash dividends on its Common Stock & the Board of Directors intends to retain all of its earnings, if any, to finance the development & expansion of its business. However, there can be no assurance that the Company can successfully expand its operations, or that such expansion will prove profitable. Future dividend policy will depend upon the Company’s earnings, capital requirements, financial condition & other factors considered relevant by the Company’s Board of Directors.
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6. SELECTED FINANCIAL DATA - None
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7. MANAGEMENT’S DISCUSSION & ANALYSIS OF FINANCIAL CONDITION & RESULTS OF OPERATIONS

The following is a discussion of the financial condition of the Company as of 1/29/2012 & 2/28/2011 & the results of operations for the fiscal years ended 2/29/2012 & 2/28/2011. It should be read in conjunction with the financial statements & the notes thereto included elsewhere in this report. The following discussion contains forward-looking statements.
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Introduction

The Company has generated no significant revenue since its inception, & does not expect to generate any operating revenues until such time, if any, as Antineoplastons are approved for use & sale by the FDA. The Company’s sole source of funding is Dr. Burzynski, who funds the Company’s operations from his medical practice pursuant to certain agreements between Dr. Burzynski & the Company. See “Certain Relationships & Related Transactions, & Director Independence.” Funds received by the Company from Dr. Burzynski are reported as additional paid-in capital to the Company.

The Company is primarily engaged as a research & development facility of Antineoplaston drugs currently being tested for use in the treatment of cancer, & provides consulting services. The Company is currently conducting 2 FDA-approved clinical trials. The Company holds the exclusive right in the US, Canada & Mexico to use, manufacture, develop, sell, distribute, sublicense & otherwise exploit all the rights, titles & interest in Antineoplaston drugs used in the treatment of cancer, once the drugs are approved for sale by the FDA. See “Certain Relationships & Related Transactions, & Director Independence.”
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Results Of Operations

Fiscal Year Ended 2/29/2012 Compared to Fiscal Year Ended 2/28/2011

Research & development costs were approximately $6,926,000 & $4,780,000 for the fiscal years ended 2/29/2012 & 2/28/2011, respectively. The increase of $2,146,000 or 45% was due to an increase in personnel cost of $93,000, an increase in material costs of $1,778,000, an increase in facility & equipment costs of $130,000, an increase in consulting & quality control costs of $142,000, & an increase in other research & development costs of $2,000.

General & administrative expenses were approximately $231,000 & $250,000 for the fiscal years ended 2/29/2012 & 2/28/2011, respectively. The decrease of $19,000 or 8% was due to a decrease in legal & professional fees of $17,000 & a decrease in other general & administrative expenses of $2,000.

The Company had net losses of approximately $7,158,000 & $5,031,000 for the fiscal years ended 2/29/2012 & 2/28/2011, respectively. The increase in the net loss from 2011 to 2012 was primarily due to an overall increase in research & development costs offset by an overall decrease in general & administrative expenses of the Company described above. As of 2/29/2012, the Company had a total stockholders’ deficit of approximately $(41,000).

Liquidity & Capital Resources

The Company’s operations have been funded entirely by Dr. Burzynski with funds generated from Dr. Burzynski’s medical practice. Effective 3/1/1997, the Company entered into a Research Funding Agreement with Dr. Burzynski (the “Research Funding Agreement”), pursuant to which the Company agreed to undertake all scientific research in connection with the development of new or improved Antineoplastons for the treatment of cancer & Dr. Burzynski agreed to fund the Company’s Antineoplaston research for that purpose. Under the Research Funding Agreement, the Company hires such personnel as is required to conduct Antineoplaston research, & Dr. Burzynski funds the Company’s research expenses, including expenses to conduct the clinical trials. Dr. Burzynski also provides the Company laboratory & research space as needed to conduct the Company’s research activities. The Research Funding Agreement also provides that Dr. Burzynski may fulfill his funding obligations in part by providing the Company such administrative support as is necessary for the Company to manage its business. Dr. Burzynski pays the full amount of the Company’s monthly & annual budget of expenses for the operation of the Company, together with other unanticipated but necessary expenses which the Company incurs. In the event the research results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions & limitations as are in the current license between Dr. Burzynski & the Company. Dr. Burzynski has unlimited & free access to all equipment which the Company owns, so long as such use does not conflict with the Company’s use of such equipment, including without limitation, all equipment used in the manufacturing of Antineoplastons used in the clinical trials. The amounts which Dr. Burzynski is obligated to pay under the agreement shall be reduced dollar for dollar by the following: (1) any income which the Company receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income, or (2) the net proceeds of any stock offering or private placement which the Company receives during the term of the agreement up to a maximum of $1,000,000 in a given Company fiscal year.

The Company entered into a 3rd amendment to the Research Funding Agreement, effective 3/1/2007, whereby the Company & Dr. Burzynski extended the term thereof until 2/28/2008, with an automatic renewal for an additional 1-year term, unless 1 party notifies the other party at least 30 days prior to the expiration of the term of the agreement of its intention not to renew the agreement. Subject to the foregoing, the term of the Research Funding Agreement was renewed & extended until 02 .28/ 2013, which extended term is also automatically renewable for an additional 1-year term unless one party notifies the other party at least 30 days prior to the expiration of the term of the agreement of its intention not to renew the agreement.

The Research Funding Agreement automatically terminates in the event that Dr. Burzynski owns less than 50% of the outstanding shares of the Company, or is removed as President and/or Chairman of the Board of the Company, unless Dr. Burzynski notifies the Company in writing of his intention to continue the agreement notwithstanding this automatic termination provision.

The Company estimates that it will spend approximately $5.0 million in the fiscal year ending 2/28/2013. The Company estimates that 95% of this amount will be spent on research & development & the continuance of FDA-approved clinical trials. While the Company anticipates that Dr. Burzynski will continue to fund the Company’s research & FDA-related costs, there is no assurance that Dr. Burzynski will be able to continue to fund the Company’s operations pursuant to the Research Funding Agreement or otherwise. However, because the net assets available to Dr. Burzynski from his personal assets & the assets of his medical practice currently exceed the Company’s projected 12-month funding requirements, the Company believes Dr. Burzynski will be financially able to fund the Company’s operations at least through the fiscal year ending 2/28/2013. In addition, Dr. Burzynski’s medical practice has successfully funded the Company’s research activities over the last 26 years &, in 1997, his medical practice was expanded to include traditional cancer tr

By Didymus Judas Thomas (not verified) on 09 Dec 2012 #permalink

I’m disappointed you hadn’t figured out that I’m responding in order by date completely incompetent at this "commenting" thing.

FTFY. HTH. HAND.

Since 9/15/2001, the Company’s Common Stock has remained in good standing for trading on the OTCBB.

Yah, as I've mentioned, the penny-stock vibe was apparent a while ago. As also mentioned, they're no longer on the OTCBB for lack of a market-maker. An old 10-K is not what is meant by "publishing," bonehead. There is no need to "read between the lines."

treatment options such as chemotherapy, immunotherapy, hormonal therapy & gene targeted therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials. As a result of the expansion of Dr. Burzynski’s medical practice, the financial condition of the medical practice has improved Dr. Burzynski’s ability to fund the Company’s operations.

Because the Company currently is entirely dependent upon the contributions for research provided by Dr. Burzynski under the Research Funding Agreement, the Company would not be able to continue conducting its clinical trials if Dr. Burzynski ceased funding the Company’s research. In such event, the Company would be required to find immediate funding which may not be available on acceptable terms or at all. If this were to occur & the Company were not able to find adequate sources of funding, the Company would be required to cease operations. Even with Dr. Burzynski’s continued contributions under the Research Funding Agreement, the Company may be required to seek additional capital through equity or debt financing or the sale of assets until the Company’s operating revenues are sufficient to cover operating costs & provide positive cash flow; however, there can be no assurance that the Company will be able to raise such additional capital on acceptable terms to the Company. In addition, there can be no assurance that the Company will ever achieve positive operating cash flow.
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8. FINANCIAL STATEMENTS & SUPPLEMENTARY DATA
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The Company’s Annual Financial Statements, Notes to Financial Statements & the report of Pannell Kerr Forster of Texas, P.C., independent registered public accounting firm, with respect thereto, referred to in the Table of Contents to the Financial Statements, appear elsewhere in this report
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9. CHANGES IN & DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING & FINANCIAL DISCLOSURE - None
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9A. CONTROLS AND PROCEDURES

(a) Evaluation of Disclosure Controls & Procedures. Within the 90 days prior to the date of this report, the Company carried out an evaluation, under the supervision & with the participation of the Company’s management, including the Company’s principal executive officer & principal financial officer, of the effectiveness of the Company’s disclosure controls & procedures pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as amended. Based upon that evaluation, the Company’s principal executive officer & principal financial officer concluded that the Company’s disclosure controls & procedures are effective & designed to ensure that the information required to be included in periodic Securities & Exchange Commission filings is recorded, processed, summarized & reported on a timely basis. A controls system cannot provide absolute assurance, however, that the objectives of the controls system are met, & no evaluation of controls can provide absolute assurance that all control issues & instances of fraud, if any, within a company have been detected.

Management’s Annual Report on Internal Control over Financial Reporting. The Company’s management is responsible for establishing & maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting & the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the US.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives.

The Company’s management, with the participation of the Company’s principal executive officer & principal financial officer, evaluated the effectiveness of the Company’s internal control over financial reporting as of 2/29/2012. In making this assessment, the Company’s management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework. Based on this evaluation, the Company’s management, with the participation of the principal executive officer & principal financial officer, concluded that, as of 2/29/2012, the Company’s internal control over financial reporting was effective.

This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the Securities & Exchange Commission that permit the company to provide only management’s report in this annual report.

(b) Changes in Internal Control Over Financial Reporting. There were no significant changes in the Company’s internal controls or in other factors that could significantly affect internal controls subsequent to the date of the evaluation above.
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9B. OTHER INFORMATION - None
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10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Set forth below are the names, ages & positions of the Company’s directors & executive officers:

Name / Age / Office
**********************************************************************
Stanislaw R. Burzynski, M.D., Ph.D. / 69 / Director & President
Barbara Burzynski, M.D. / 71 / Director
Michael H. Driscoll, J.D. / 66 / Director
Carlton Hazlewood, Ph.D. / 76 / Director
Gregory S. Burzynski, M.D. / 32 / Director
Patryk P. Goscianski, M.B.A. / 34 / Treasurer & Secretary
Tomasz Janicki, M.D. / 46 / Vice President of Clinical Trials
*********************************************************************
STANISLAW R. BURZYNSKI, M.D., PH.D., has been the President & Chairman of the Board of Directors of the Company since its inception in 1984. He also served as the Company’s Secretary & Treasurer until 3/1/2012. Dr. Burzynski is a physician in private practice in Houston, Texas specializing in the treatment of cancer. Dr. Burzynski is the husband of Barbara Burzynski, M.D. & father of Gregory S. Burzynski, who are each directors of the Company.

Currently listed in Who’s Who In The World & a member in good standing with both the American & World Medical Associations, Dr. Burzynski is an internationally recognized physician & scientist who has pioneered the development & use of biologically active peptides in diagnosing, preventing, & treating cancer since 1967. In 1967, Dr. Burzynski graduated with distinction with an M.D. degree from the Medical Academy in Lublin, Poland, finishing first in his class of 250, & he subsequently earned his Ph.D. in Biochemistry.

From 1970 to 1977, he was a researcher & Assistant Professor at Baylor College of Medicine in Houston. At Baylor, Dr. Burzynski’s research was sponsored & partially funded by the National Cancer Institute. Also at Baylor, he authored & co-authored 16 publications, including five concerning his research on peptides & their effect on human cancer. 4 of these publications were also co-authored by other doctors associated with M.D. Anderson Hospital & Tumor Institute & Baylor College of Medicine. In May 1977, Dr. Burzynski received a Certificate of Appreciation from Baylor College of Medicine & in that same year founded the Company.

Dr. Burzynski is a member of the American Medical Association, American Association for Cancer Research, Harris County Medical Society, New York Academy of Sciences, Society for Neuroscience, Texas Medical Association, the Society of Sigma Xi, & the Society of Neuro-oncology. He is the author of over 300 scientific publications, presenter of scientific papers at major international conventions, & has been awarded 243 patents covering 42 countries for his Antineoplaston treatment & other inventions. Other groups are working in conjunction with him, including researchers at the University of Kurume Medical School in Japan.
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BARBARA BURZYNSKI, M.D., a Director since 1984 & the wife of Dr. Burzynski, has been the Chairman of the Department of Pharmacy of the Burzynski Clinic since 1977. From January 1976 to July 1977, she was a Research Assistant in the Department of Pediatrics at Baylor College of Medicine. She was a physician at the Medical Academy, Lublin, Poland, from 1970 to 1975. Dr. Barbara Burzynski graduated with an M.D. in 1966 from the Medical Academy, Lublin, Poland, & has published 6 publications on studies with Antineoplastons.
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MICHAEL H. DRISCOLL, J.D. has been a Director of the Company since 1984. Mr. Driscoll was formerly a judge & served as the County Attorney of Harris County, Texas from 1981 until he retired in 1997.
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CARLTON HAZLEWOOD, PH.D. has been a Director of the Company since 1997. He also serves as Chairman of the IRB, an independent review board for the Company’s clinical trials designated according to federal regulations. Dr. Hazlewood currently operates his own consulting company, Research Consultant’s International, is president of Petroclean, L.L.C. & is an adjunct professor at Kingwood College. In addition, Dr. Hazlewood was employed in various capacities by the Baylor College of Medicine from 1965 until December 31, 1997, where he was a professor of Molecular Biology & Biophysics. Dr. Hazlewood received his Ph.D. in Medical Physiology from the University of Tennessee. Dr. Hazlewood is a prolific writer on medical topics & has been recognized for his research with numerous awards, honors & research grants.
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GREGORY S. BURZYNSKI, M.D. has been a Director of the Company since 2011. Dr. Gregory Burzynski is a licensed medical doctor who has worked at the Burzynski Clinic in Houston, Texas since July 2010. After Dr. Gregory Burzynski graduated from Jagiellonian University Medical College in 2007, he was accepted in the internal medicine residency program of the University of Texas Southwestern Medical Center in Austin, Texas. He is currently the Vice President of the Burzynski Clinic. In addition, Dr. Gregory Burzynski is board certified in internal medicine & has been involved in co-authoring numerous publications regarding Antineoplastons.
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PATRYK P. GOSCIANSKI, M.B.A. was appointed as the Treasurer & the Secretary of the Company on 3/1/2012. Mr. Goscianski currently works at Burzynski Clinic. Mr. Goscianski joined Burzynski Clinic in Houston, TX in 2011 & holds the positions of Director of Finance & Director of Administration, where he oversees the external financial reporting for Burzynski Clinic as well as manages various other accounting, finance & administrative functions. In the past few years, Mr. Goscianski has worked for a variety of companies in areas of finance & business consulting. Mr. Goscianski holds a Bachelor of Business Administration degree from Texas State University & a Masters of Business Administration degree from the University of North Alabama.
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TOMASZ JANICKI, M.D. was appointed as the Vice President of Clinical Trials of the Company on 3/1/2012. Dr. Janicki currently works at Burzynski Clinic. Dr. Janicki joined Burzynski Clinic in 1997 as Research Associate & has served as Director of Medical Documentation at Burzynski Clinic since 2002. Dr. Janicki has been involved in the administrative oversight of the Research Department at Burzynski Clinic, & has co-authored 43 publications & presentations for the advancement & acceleration of research & clinical trials at Burzynski Clinic. Dr. Janicki received his M.D. degree from Medical University in Wroclaw, Poland. Dr. Janicki is the son-in-law of Dr. Stanislaw Burzynski.
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Audit Committee Financial Expert

The Company has not established an Audit Committee. Therefore, the Board of Directors has not designated any of its members as an “audit committee financial expert” as defined by the rules & regulations of the Securities and Exchange Commission.
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Section 16(a) Beneficial Ownership Reporting Compliance

Based solely upon a review of Forms 3 & 4 & amendments thereto furnished to the Company under Rule 16a-3(e) during the fiscal year ended 2/29/2012 & Form 5 & amendments thereto furnished to the Company with respect to such period, except as set forth below, the Company is not aware of any director, officer, or beneficial owner of more than 10% of any class of equity securities of the Company registered pursuant to Section 12 of the Securities Exchange Act of 1934 (the “Exchange Act”) that has failed to file on a timely basis, as disclosed in the above forms, reports required by Section 16(a) of the Exchange Act during the Company’s most recent fiscal year. A Form 3 was not filed for Gregory S. Burzynski, Patryk P. Goscianski & Tomasz Janicki during the fiscal year ended 2/29/2012; instead, a Form 5 was filed with the Securities & Exchange Commission on 4/12/2012 for each such individual.
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Code of Ethics

The Company has adopted a code of ethics that applies to our chief executive officer, chief financial officer, chief accounting officer & all persons performing similar functions. The Company hereby undertakes to provide a copy of this code of ethics to any person, without charge upon request made in writing to: Investor Relations, 9432 Katy Freeway, Houston, Texas 77055.
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ITEM 11. EXECUTIVE COMPENSATION

SUMMARY COMPENSATION TABLE

Annual Compensation

Long-Term Compensation

Name and Principal Position / Fiscal Yea Ending / Salary($) / Bonus ($) /Other Annual Compensation ($) / Restricted Stock Awards($) / Securities Underlying Options/SARs($) / LTIP Payouts ($) / All Other Compensatio ($)
=========================================
Stanislaw R. Burzynski, M.D., Ph.D., President & Chairman of the Board of Directors (1)
2010 -0- / -0- / -0- / -0- / -0- / -0- / -0-
2011 -0- / -0- / -0- / -0- / -0- /-0- / -0-
2012 -0- / -0- / -0- / -0- / -0- / -0- / -0-
=========================================
Patryk P. Goscianski, M.B.A., Treasurer & Secretary (2)
2012 -0- / -0- / -0- / -0- / -0- / -0- / -0-
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Tomasz Janicki, M.D., Vice President of Clinical Trials (3)
2012 -0- / -0- / -0- / -0- / -0- / -0- / -0-
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(1) In May of 2000, Dr. Burzynski began drawing his entire salary through his medical practice & is not currently compensated by the Company for his services.
.....................................................................................................
(2) Mr. Goscianski is not currently compensated by the Company for his services.
.....................................................................................................
(3) Dr. Janicki is not currently compensated by the Company for his services. .....................................................................................................
Directors do not receive any compensation for serving as directors; however, directors are reimbursed for all ordinary & necessary expenses incurred in attending meetings of the Board of Directors or otherwise incurred in their capacity as directors. In addition, any director also serving as a director of the IRB, the independent review board for the Company’s clinical trials designated according to federal regulations, is compensated by the IRB approximately $1,200 annually for serving as a director of the IRB.
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12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth, as of 5/1/2012, the # of outstanding shares of Common Stock (the Company’s only class of voting securities) owned by (i) each person known by the Company to beneficially own more than 5% of its outstanding Common Stock, (ii) each director, (iii) each named executive officer, & (iv) all officers & directors as a group. The address for all of the beneficial owners listed below is the Company’s address.

Name of beneficial owner / Amount and nature of beneficial ownership / Percent of class (1)
==========================================
Stanislaw R. Burzynski, M.D., Ph.D. / 106,368,278 / 80.9%
==========================================
Barbara Burzynski, M.D. / 106,368,278 / (2) / 80.9%
==============================•===========
Michael H. Driscoll / 125,000 / *
Carlton Hazlewood / 0 / *
Gregory S. Burzynski, M.D. / 55,912 / *
Patryk P. Goscianski, M.B.A. / 0 / *
Tomasz Janicki, M.D. / 55,912 / *
=========================================
All Current Directors & Executive Officers as a group (7 persons)
106,605,102 / 81.1% / *Less than 1#.
.....................................................................................................
(1)Percentages shown are based upon 131,448,444 shares of Common Stock outstanding as of 5/1/2012. Certain shares are deemed beneficially owned by more than 1 person listed in the table.
.....................................................................................................
(2)All of the shares listed above for Dr. Barbara Burzynski are included in the total # of shares for Dr. Burzynski, her husband.
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13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Dr. Burzynski is the President & Chairman of the Board of the Company, as well as the beneficial owner of 80.9% of the Company’s outstanding Common Stock. Since 1983, Dr. Burzynski has personally funded & supported the Company’s operations out of funds generated from his medical practice pursuant to various agreements with the Company.
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License Agreement

The Company entered into the License Agreement with Dr. Burzynski which gives the Company the exclusive right in the Territory (composed of the US, Canada & Mexico) to use, manufacture, develop, sell, distribute, sublicense & otherwise exploit all of his rights, title & interests in Antineoplastons in the treatment & diagnosis of cancer, including but not limited to any patent rights which may be granted in these countries. The License Agreement will terminate upon the earlier of the expiration of the last patent licensed to the Company, or termination by Dr. Burzynski, at his option, if he is removed as a director or officer of the Company without his consent, if the Company files for bankruptcy or is the subject of any proceeding under applicable bankruptcy laws where such proceeding is not dismissed within 90 days from the date a petition is filed, or if any shareholder or group of shareholders acting in concert becomes the beneficial owner of the Company’s securities having voting power equal to or greater than the voting power of the securities Dr. Burzynski holds. Amendments to the License Agreement on 4/24/1984 & on 3/1/1990 granted Dr. Burzynski the limited right to manufacture, use, & exploit Antineoplastons in the Company’s exclusive territory solely for the purpose of enabling Dr. Burzynski to treat patients in his medical practice until such date that the FDA may approve the sale of Antineoplastons for the treatment of cancer in the US.
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Research Funding Arrangements

Effective 3/1/1997, the Company entered into the Research Funding Agreement with Dr. Burzynski & terminated all of the prior funding agreements between the Company & Dr. Burzynski. Pursuant to the Research Funding Agreement:

·The Company agreed to undertake all scientific research in connection with the development of new or improved Antineoplastons for the treatment of cancer & other diseases. The Company will hire such personnel as is required to fulfill its obligations under the agreement;

·Dr. Burzynski agreed to fund in its entirety all basic research which the Company undertakes in connection with the development of other Antineoplastons or refinements to existing Antineoplastons for the treatment of cancer & other diseases;

·Dr. Burzynski agreed to pay the expenses to conduct the clinical trials for the Company;

·Dr. Burzynski agreed to provide the Company such laboratory, research space & office space as the Company needs at no charge to the Company;

·The parties agreed that Dr. Burzynski may fulfill his obligations in part by providing such administrative staff as is necessary for the Company to manage its business, at no cost to the Company;

·Dr. Burzynski agreed to pay the full amount of the monthly & annual budget of expenses for the operation of the Company, together with such other unanticipated but necessary expenses which the Company incurs. Payments from Dr. Burzynski to the Company of the monthly budget shall be made in 2 equal installments on the 1st & 15th of each month;

·In the event the research described in the agreement results in the approval of any additional patents, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions & limitations as provided by the License Agreement;

·Dr. Burzynski shall have unlimited & free access to all equipment which the Company owns, so long as such use is not in conflict with the Company’s use of such equipment, including without limitation to all equipment used in manufacturing of Antineoplastons used in the clinical trials;

·The amounts which Dr. Burzynski is obligated to pay under the agreement shall be reduced dollar for dollar by the following:

·Any income which the Company receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income (such as the purchase of chemicals, products or equipment solely necessary to engage in such other research & development activity); &

·The net proceeds of any stock offering or private placement which the Company receives during the term of the agreement up to a maximum of $1,000,000 in a given Company fiscal year.

Effective 3/1/2007, the Company entered into a 3rd amendment to the Research Funding Agreement, whereby the Company & Dr. Burzynski extended the term thereof until 2/28/2008, with an automatic renewal for an additional 1-year term, unless 1 party notifies the other party at least 30 days prior to the expiration of the term of the agreement of its intention not to renew the agreement. In addition to the foregoing termination provisions, the agreement automatically terminates in the event that Dr. Burzynski owns less than 50# of the outstanding shares of the Company, or is removed as President and/or Chairman of the Board of the Company, unless Dr. Burzynski notifies the Company in writing of his intention to continue the agreement notwithstanding this automatic termination provision. Subject to the foregoing, the term of the Research Funding Agreement was renewed & extended until 2.28/2013, which extended term is also automatically renewable for an additional 1-year term unless 1 party notifies the other party at least 30 days prior to the expiration of the term of the agreement of its intention not to renew the agreement.
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Royalty Agreement

The Company & Dr. Burzynski entered into the Royalty Agreement, pursuant to which Dr. Burzynski agreed to act as the principal clinical investigator of the clinical trials necessary for obtaining FDA approval for interstate marketing of Antineoplastons. The Company & Dr. Burzynski agreed that in the event the Company receives FDA approval for interstate marketing & distribution, of which there can be no assurance, the Company shall pay Dr. Burzynski a royalty of 10% of the Company’s gross income, which royalty shall be paid on all gross receipts from all future sales, distributions & manufacture of Antineoplastons.

Pursuant to the Royalty Agreement, Dr. Burzynski retains the right to either (i) produce Antineoplaston products for use in his medical practice to treat up to 1,000 patients, at any one time, without paying any fees to the Company or (ii) purchase from the Company Antineoplaston products to treat up to 1,000 patients, at any one time, at a price equal to cost plus 10%. Dr. Burzynski has the right to lease or purchase all the manufacturing equipment located at Stafford, Texas at a fair market price. The Royalty Agreement further provides that the Company will have the right, when & if Antineoplastons are approved for use & sale by the FDA, (i) to produce all Antineoplaston products to be sold or distributed in the US, Canada &Mexico for the treatment of cancer & (ii) to lease from Dr. Burzynski the entire premises located at Stafford, Texas at terms & rates competitive with those available in the real estate market at that time, provided that Dr. Burzynski does not need the facility for his use.
----------------------------------------------------------
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

The following table sets forth the aggregate fees billed to the Company by its independent registered public accounting firm, PKF, for fiscal years ended 2/29/2012 & 2/28/2011, respectively:
*********************************************************************
2012 / 2011

Audit Fees
$43,000 / $43,000

Audit-Related Feesp
0 / 0

Tax Fees
0 / 0

All Other Fees
0 / 0

Total
$43,000 / $43,000

Audit Fees were for professional services rendered for the audit of BRI’s financial statements & review of the interim financial statements included in quarterly reports & services that are normally provided in connection with statutory & regulatory filings or engagements.

Audit-Related Fees are for assurance & related services that are reasonably related to the performance of the audit or review of BRI’s financial statements & are not reported under “Audit Fees.” There were no Audit-Related Fees incurred in fiscal years 2012 or 2011.

Tax Fees were for professional services for federal & state tax compliance, tax advice & tax planning. There were no Tax Fees incurred in fiscal years 2012 or 2011.

All Other Fees were for services other than the services reported above. There were no Other Fees incurred in fiscal years 2012 or 2011.

Audit Committee’s Pre-Approval Policies & Procedures. As disclosed above in Item 9, the Company does not have an Audit Committee. The Board of Directors has not adopted any pre-approval policies or procedures.
---------------------------------------------------------- 15. EXHIBITS & FINANCIAL STATEMENT SCHEDULES

Certificate of Incorporation of the Company, as amended (incorporated by reference from Exhibit 3(i) — (iii) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

Amended Bylaws of the Company (incorporated by reference from Exhibit (3)(iv) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

Form of Certificate Representing Common Stock (incorporated by reference from Exhibit 4.1 to Form 10-KSB filed with the Securities & Exchange Commission on 5/2/2001 (File No. 000-23425)).

License Agreement, effective as of 6/29/1983, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10(1) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

Amended License Agreement, dated 4/2/1984, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by referenced from Exhibit 10(2) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

2nd Amended License Agreement, dated 3/1/1990, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10(3) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

Research Funding Agreement, effective as of 3/1/1997, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10(4) to Form 10-SB filed with the Securities & Exchange Commission on 1-/25/1997 (File No. 000-23425)).

First Amendment to Research Funding Agreement, effective as of 3/1/2001, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10.5 to Form 10-KSB filed with the Securities & Exchange Commission on 5/2/2001 (File No. 000-23425)).

2nd Amendment to the Research Funding Agreement, effective as of 2/29/2004, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10.6 to Form 10-KSB filed with the Securities & Exchange Commission on 6/1/2004 (File No. 000-23425)).

Royalty Agreement, dated 3/25/1997, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10(5) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

1st Amended Royalty Agreement, dated 9/29/1997, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10(6) to Form 10-SB filed with the Securities & Exchange Commission on 11/25/1997 (File No. 000-23425)).

3rd Amendment to Research Funding Agreement, effective as of 3/1/2007, by & between the Company & Dr. Stanislaw R. Burzynski (incorporated by reference from Exhibit 10.9 to Form 10-KSB filed with the Securities & Exchange Commission on 5/29/2007 (File No. 000-23425)).
*********************************************************************
Power of Attorney (Included with the Signature Page).

Certification pursuant to Rules 13a-14 & 15d-14 of the Securities Exchange Act of 1934, as amended, filed herewith (Chief Executive Officer).

Certification pursuant to Rules 13a-14 & 15d-14 of the Securities Exchange Act of 1934, as amended, filed herewith (Principal Financial Officer).

Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer).

Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Principal Financial Officer).

101.INS / XBRL Instance Document

101.SCH / XBRL Taxonomy Extension Schema Document

mt

101.CAL / XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF / XBRL Taxonomy Extension Definition Linkbase Document

101.LAB / XBRL Taxonomy Extension Label Linkbase Document

101.PRE / XBRL Taxonomy Extension Presentation Linkbase Document
*********************************************************************
SIGNATURES

In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
=========================================
BURZYNSKI RESEARCH INSTITUTE, INC.
By:
/s/ Stanislaw R. Burzynski
Stanislaw R. Burzynski, President & Chairman of the Board of Directors
Date: 5/29/2012
=========================================
Each person whose signature appears below constitutes & appoints Dr. Stanislaw R. Burzynski his/her true & lawful attorney-in-fact & agent, with full power of substitution & resubstitution, severally, for him/her in his/her name, place & stead, in any & all capacities, to sign any & all amendments to this report, & to file the same, with all exhibits thereto & other documents in connection therewith, with the Securities & Exchange Commission, granting unto said attorney-in-fact & agent full power & authority to do & perform each & every act & thing requisite & necessary to be done in & about the premises, as fully to all intents & purposes as he/she might or could do in person, hereby ratifying & confirming all that said attorney-in-fact & agent may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1934, this report has been signed below by the following persons in the capacities & on the dates indicated.
.....................................................................................................
/s/ Stanislaw R. Burzynski
Stanislaw R. Burzynski
Date: 5/29/2012
President & Chairman of the Board of Directors
.....................................................................................................
/s/ Barbara Burzynski
Barbara Burzynski
Date: 5/29/2012
Director
.....................................................................................................
/s/ Michael H. Driscoll
Michael H. Driscoll
Date: 5/29/2012
Director
.....................................................................................................
/s/ Carlton Hazlewood
Carlton Hazlewood
Date: 5//9/2012
Director
.....................................................................................................
/s/ Gregory S. Burzynski
Gregory S. Burzynski, M.D.
Director
Date: 5/29/2012
.....................................................................................................
/s/ Patryk P. Goscianski
Patryk P. Goscianski, M.B.A.
Treasurer & Secretary
Date: 5/29/2012
.....................................................................................................
/s/ Tomasz Janicki
Tomasz Janicki, M.D.
Vice President of Clinical Trials
Date: 5/29/2012
*********************************************************************
Burzynski Research Institute, Inc.

Financial Statements

For the years ended
2/29/2012 & 2/28/2011
----------------------------------------------------------
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors & Stockholders
of Burzynski Research Institute, Inc.

We have audited the accompanying balance sheets of Burzynski Research Institute, Inc. as of 2/29/2012 & 2/28/2011 & the related statements of operations, stockholders’ deficit, & cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan & perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, audits of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining on a test basis, evidence supporting the amounts & disclosures in the financial statements. An audit includes assessing the accounting principles used & significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Burzynski Research Institute, Inc. as of 2/29/2012 ' 2/28/2011, & the results of its operations & its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
5/29/2012
Houston, Texas
/s/ Pannell Kerr Forster of Texas, P.C.
*********************************************************************
BURZYNSKI RESEARCH INSTITUTE, INC.
BALANCE SHEETS
For the Years Ended 2/29/2012 & 2/28/2011

2012 / 2011

ASSETS

Current assets
.....................................................................................................
Cash & cash equivalents
$17,297 / $17,476
.....................................................................................................
Total current assets
17,297 / 17,476
.....................................................................................................
Property & equipment, net of accumulated depreciation
3,419/ 4,120
.....................................................................................................
Total assets
$20,716 / $21,596
----------------------------------------------------------
LIABILITIES & STOCKHOLDERS’ DEFICIT

Current liabilities
.....................................................................................................
Accounts payable
$12,265 / $39,223
.....................................................................................................
Accrued liabilities
49,699 / 33,628
.....................................................................................................
Total current liabilities
61,964 / 72,851
.....................................................................................................
Total liabilities
61,964 / 72,851
.....................................................................................................
Commitments & contingencies
— / —
.....................................................................................................
Stockholders’ deficit

Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 shares issued & outstanding as of 2//9/2012 & 2/28/2011

131,449 / 131,449
.....................................................................................................
Additional paid-in capital
101,428,376 / 94,260,707
.....................................................................................................
Retained deficit
(101,601,073) / (94,443,411)
.....................................................................................................
Total stockholders’ deficit
(41,248) / (51,255)
.....................................................................................................
Total liabilities and stockholders’ deficit
$20,716 / $21,596
.....................................................................................................
The accompanying notes are an integral part of these financial statements.
----------------------------------------------------------
BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENTS OF OPERATIONS
For the Years Ended 2/29/2012 & 2/28/2011
2012 / 2011

Operating expenses
.....................................................................................................
Research & development
$6,925,519 / $4,780,072
.....................................................................................................
General & administrative
231,442 / 250,434
.....................................................................................................
Depreciation
701 / 736
.....................................................................................................
Total operating expenses
7,157,662 / 5,031,242
.....................................................................................................
Operating loss before other income
(7,157,662) / (5,031,242)
.....................................................................................................
Other income
— / —
.....................................................................................................
Loss before provision for income tax
(7,157,662) / (5,031,242)
.....................................................................................................
Income tax expense
— / —
.....................................................................................................
Net loss
$(7,157,662) / $(5,031,242)
.....................................................................................................
Net loss per common share:
Basic & diluted
$(0.05) / $(0.04)
.....................................................................................................
Weighted average common shares outstanding:
Basic & diluted
131,448,444 / 131,443,156
.....................................................................................................
The accompanying notes are an integral part of these financial statements.
----------------------------------------------------------
BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENTS OF STOCKHOLDERS’ DEFICIT
For the Years Ended 2/29/2012 & 2/28/2011

Additional

Total

Common Stock
Paid-in / Retained

Stockholders’
Shares / Amount

Capital
Deficit / Deficit
.....................................................................................................
Balance February 28, 2010
131,388,444 / $131,389 / $89,232,302 / $(89,412,169) / $(48,478)
.....................................................................................................
Cash contributed by S.R. Burzynski M.D., Ph.D.
— / — / 505,110 / — / 505,110
.....................................................................................................
Shares issued (60,000) for services rendered pursuant to prior year obligation
60,000 / 60 / (60) / — / —
.....................................................................................................
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph. D.
— / — / 4,523,355 / — / 4,523,355
.....................................................................................................
Net loss
— / — / — / (5,031,242) / (5,031,242)
.....................................................................................................
Balance 2/28/2011
131,448,444 / 131,449 / 94,260,707 / (94,443,411) / (51,255)
.....................................................................................................
Cash contributed by S.R. Burzynski M.D., Ph.D.
— / — / 503,885 / — / 503,885
.....................................................................................................
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph. D.
— / — / 6,663,784 / — / 6,663,784
.....................................................................................................
Net loss
— / — / — / (7,157,662) / (7,157,662)
.....................................................................................................
Balance 2/29/2012
131,448,444 / $131,449 / $101,428,376
$(101,601,073) / $(41,248)
.....................................................................................................
The accompanying notes are an integral part of these financial statements.
----------------------------------------------------------
BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENTS OF CASH FLOWS
For the Years Ended 2/29/2012 & 2/28/2011
2012 / 2011
.....................................................................................................
CASH FLOWS FROM OPERATING ACTIVITIES

Net loss
$(7,157,662) / $(5,031,242)
.....................................................................................................
Adjustments to reconcile net loss to net cash used by operating activities:

Depreciation
701 / 736
.....................................................................................................
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph. D.
6,663,784 / 4,523,355
.....................................................................................................
Change in operating assets & liabilities

Accounts payable
(26,958) / (2,548)
.....................................................................................................
Accrued liabilities
16,071 / 3,943
----------------------------------------------------------
NET CASH USED IN OPERATING ACTIVITIES
(504,064) / (505,756)
----------------------------------------------------------
CASH FLOWS FROM FINANCING ACTIVITIES
Cash contribution recorded
503,885 / 505,110
----------------------------------------------------------
NET CASH PROVIDED BY FINANCING ACTIVITIES
503,885 / 505,110
----------------------------------------------------------
NET DECREASE IN CASH
(179) / (646)
----------------------------------------------------------
CASH AT BEGINNING OF YEAR
17,476 / 18,122
----------------------------------------------------------
CASH AT END OF YEAR
$17,297 / $17,476
----------------------------------------------------------
SUPPLEMENTAL CASH FLOW DISCLOSURES:
Cash Paid During the Year For:
Taxes
$0 / $0
.....................................................................................................
The accompanying notes are an integral part of these financial statements.
----------------------------------------------------------
BURZYNSKI RESEARCH INSTITUTE, INC.
NOTES TO FINANCIAL STATEMENTS

1. Background, Basis of Presentation, Economic Dependency & Significant Accounting Policies:
.....................................................................................................
Background & Basis of Presentation

The financial statements of Burzynski Research Institute, Inc. (the Company), a Delaware corporation, include expenses incurred related to clinical trials, which were sanctioned by the U.S. Food & Drug Administration (FDA) in 1993, for antineoplaston drugs used in the treatment of cancer. These expenses are incurred directly by S.R. Burzynski, M.D., Ph.D. (Dr. Burzynski or “SRB”) on behalf of the Company & have been reported as research & development costs & as additional paid-in capital. Other funds received from Dr. Burzynski have also been reported as additional paid-in capital. Expenses related to Dr. Burzynski’s medical practice (unrelated to the clinical trials) have not been included in these financial statements. Dr. Burzynski is the President, Chairman of the Board & owner of 80.9% of the outstanding common stock of the Company, & also is the inventor & original patent holder of certain drug products knows as “antineoplastons,” which he has licensed to the Company.

The Company & Dr. Burzynski have entered into various agreements, as further described in Note 2, which provide the Company the exclusive right in the US, Canada & Mexico to use, manufacture, develop, sell, distribute, sublicense & otherwise exploit all the rights, titles & interest in antineoplaston drugs used in the treatment of cancer, once the drug is approved for sale by the FDA.

BRI’s administrative offices are located in Houston, Texas; its research & production facilities are in Stafford, Texas. The Company operates primarily as a research & development facility of antineoplaston drugs currently being tested for the use in the treatment of cancer, & provides consulting services. Segment information is not presented since all of the Company’s operations are attributed to a single reportable segment. The Company has had no significant revenue from external sources. The Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations, however, at this time none of the antineoplaston drugs have received FDA approval; further, there can be no assurance FDA approval will be granted.
.....................................................................................................
Economic Dependency

BRI has generated no significant revenues since its inception. As of 2/29/2012, the Company had a working capital deficit of approximately $45,000 & accumulated deficit of approximately $101,601,000. For the years ended 2/29/2012 & 2/28/2011 the Company incurred losses of approximately $7,158,000 & $5,031,000, respectively.

Dr. Burzynski has funded the capital &operational needs of the Company since its inception from revenues generated through his medical practice pursuant to various agreements as described in Note 2.

The Company is economically dependent on its funding from Dr. Burzynski through his medical practice. Management estimates that approximately 1/10th of Dr. Burzynski’s patients are admitted & treated as part of the clinical trial programs which the FDA regulates. The FDA imposes numerous regulations & requirements regarding these patients & the Company is subject to inspection at any time by the FDA. These regulations are complex & subject to interpretation & though it is management’s intention to comply fully with all such regulations, there is the risk that the Company is not in compliance & is thus subject to sanctions imposed by the FDA.

In addition, as with any medical practice, Dr. Burzynski is subject to potential claims by patients & other potential claimants commonly arising out of the operation of a medical practice. The risks associated with Dr. Burzynski’s medical practice directly affect his ability to fund the operations of BRI.

It is the intention of the directors & management to seek additional capital through the sale of securities. The proceeds from such sales will be used to fund BRI’s operating deficit until it achieves positive operating cash flow. However, there can be no assurance that the Company will be able to raise such additional capital.
.....................................................................................................
Significant Accounting Policies
Cash & Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity of 3 months or less to be cash equivalents.
.....................................................................................................
Property & Equipment

Property & equipment are recorded at cost & depreciated using the straight-line method over the estimated useful lives of the assets, which range from 5 to 10 years. Expenditures for major renewals & betterments that extend the useful lives of property & equipment are capitalized; maintenance & repairs are charged against earnings as incurred. Upon disposal of assets, the related cost & accumulated depreciation are removed from the accounts & any resulting gain or loss is recognized currently.
.....................................................................................................
Income Taxes

The Company uses the asset & liability method of accounting for income taxes, under which deferred income taxes are recognized for the tax consequences of temporary differences by applying the enacted statutory tax rate applicable to future years to differences between financial statement carrying amounts & the tax basis of existing assets & liabilities.

Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable or refundable for the period plus or minus the change during the period in deferred tax assets & liabilities. The costs incurred related to the conduct of FDA approved clinical trials incurred directly by Dr. Burzynski within his medical practice are deducted by Dr. Burzynski & are not included in the Company’s tax provision. The portion of the Texas gross margin tax that is based on income is treated as income taxes & included in the income tax provision.

Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740-10, Accounting for Uncertainty in Income Taxes, clarifies the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. ASC 740-10 also provides guidance on derecognition, measurement, classification, interest & penalties, accounting interim periods, disclosure, & transition. For the years ended 2/29/2012 & 2/28/2011, no uncertain tax positions were identified.
.....................................................................................................
Loss Per Common Share

Basic & diluted loss per common share information for all periods is presented under the requirements of FASB ASC 260 “Earnings per Share.” Basic loss per common share has been computed using the weighted average # of common shares outstanding during the period. Potentially dilutive securities have been excluded from the computation of diluted loss per common share, as their inclusion would be antidilutive.
.....................................................................................................
Research & Development

Research & development cost are charged to operations in the period incurred. Equipment used in research & development activities, which have alternative uses, is capitalized.
.....................................................................................................
Fair Value of Financial Instruments

The carrying value of cash & accounts payables approximates fair value due to the short term maturity of these instruments. None of the financial instruments are held for trading purposes.
.....................................................................................................
Management Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates & assumptions that affect reported amounts of assets & liabilities at the dates of the financial statements & the reported amounts of revenues & expenses during the reported periods. The significant estimates are the allocation of payroll & other expenses between the clinical trial expenses reported with Burzynski Research Institute, Inc. &Dr. Burzynski’s medical practice expenses. Department managers review at least quarterly the duties of each employee in their department & estimate the percentage of time each employee spends between clinical trials & the medical practice. Payroll costs are allocated between clinical trials & the medical practice based on these percentages. Other expenses are allocated based on the % of payroll allocated to either clinical trials or the medical practice. Management believes that the estimates & allocations are reasonable. Actual results could differ from these estimates.
.....................................................................................................
Stock Options

The Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation — Stock Compensation”, which requires the measurement & recognition of compensation expense for all share-based payment awards made to employees &non-employee officers based on estimated fair values as of the date of grant. Compensation expense is recognized on a straight-line basis over the requisite service period.

The Company did not grant any options & no options previously granted vested in any of the periods presented in these financial statements. Thus, there was no effect on net loss & earnings per share regarding the provisions of FASB ASC 718 in any of the periods presented.
.....................................................................................................
2. Agreements With, & Other Related Party Transactions:

The Company has agreements with its majority shareholder & President Dr. Burzynski as further described below:
.....................................................................................................
License Agreement

Dr. Burzynski is the owner of patents involving the formulation, preparation, manufacture, production, use, dosage & treatment with antineoplastons. The US Office & Patent Offices & Patent Officers of 34 other countries have issued the patents. The Patents for cancer treatment & diagnosis in the US & Canada are licensed to the Company pursuant to a License Agreement.

The License Agreement grants to the Company the exclusive right, in the US, Canada, & Mexico, to use, manufacture, develop, sell, distribute, sub-license & otherwise exploit all of Dr. Burzynski’s rights, title, & interests, including patent rights, in antineoplaston drugs in the treatment & diagnosis of cancer. The Company will not be able to exploit such rights until such time as antineoplastons are approved, of which there can be no assurance, by the FDA for sale in the US & the appropriate authority in Canada & Mexico.

The Agreement gives Dr. Burzynski the right to make, use, sell, distribute, & otherwise exploit antineoplastons in connection with the treatment of patients in his medical practice.

The License Agreement will terminate upon the earlier of the expiration of the last patent licensed to the Company, or termination by Dr. Burzynski, at his option, if he is removed as a director or officer of the Company without his consent, if the Company files for bankruptcy or if any shareholder or group of shareholders acting in concert becomes the beneficial owner of the Company’s securities having voting power = to or greater than the voting power of the securities Dr. Burzynski holds.

Under the License Agreement, the Company currently owns exclusive rights to 8 issued US Patents, 4 issued Canadian Patents & 1 issued Mexican Patent.

The 5 initial US Patents (the “Initial Patents”) relate to: (i) Determination of Antineoplastons in body tissue or fluids as a testing procedure to aid in the diagnosis of cancer; (ii) Processes for the preparation of purified fractions of Antineoplastons from human urine; (iii) Processes for the synthetic production of Antineoplastons & methods of treating neoplastic disease (cancer); (iv) Administration of Antineoplastons to humans; & (v) Methods of synthesizing A-10. All of these Initial Patents have expired as of 2/28/2009. The Company does not believe the expiration of any of the Initial Patents will have a material adverse effect on the Company.

The 6th US Patent (the “2000 U.S. Patent”) covers Liposomal Antineoplaston therapies with markedly improved anti-cancer activity. The 2000 U.S. Patent expires 5.14/2017.

The 7th US Patent (the “2001 U.S. Patent”) is for a treatment regimen for the administration of phenylacetylglutamine, phenylacetylisoglutamine, and/or phenylacetate. The 2001 U.S. Patent expires on 8.23/2018.

The 8th US Patent (the “2005 U.S. Patent”) relates to a divisional application to the 2001 U.S. Patent. The 2005 U.S. Patent was issued in September 2005 & will expire 7.31/2018.

The 4 Canadian Patents (the “Canadian Patents”) relate to: (i) Processes for the preparation of purified fractions of Antineoplastons from human urine, (ii) Processes for the synthetic production of Antineoplastons & methods of treating neoplastic disease (cancer), (iii) Liposomal formulation of Antineoplastons & (iv) Treatment regimen for the administration of phenylacetylglutamine. The Canadian Patents expired or will expire on 6/4/2002, 11/14/2006, 5.14/2017, & 7.2/2019, respectively; however, the Company does not believe the Canadian Patents that expired in 2002 or in 2006 will have a material adverse effect on the Company.

The Mexican Patent relates to a treatment regimen for the administration of phenylacetylglutamine. This patent will expire 1.14/2019.
.....................................................................................................
Research Funding Agreement

Effective 3/1/1997, Dr. Burzynski restructured his funding arrangement with the Company & entered into a Research Funding Agreement. Under this agreement the 2 parties agreed to the following:
.....................................................................................................
1. The Company agrees to undertake all scientific research in connection with the development of new or improved antineoplastons for the treatment of cancer. The Company will hire such personnel as is required to fulfill its obligations under the agreement.
.....................................................................................................
2. Dr. Burzynski agrees to fund in its entirety all basic research, which the Company undertakes in connection with the development of other antineoplastons or refinements to existing antineoplastons for the treatment of cancer.
.....................................................................................................
3. As FDA approval of antineoplastons will benefit both parties, Dr. Burzynski agrees to pay the expenses to conduct the clinical trials for the Company.
.....................................................................................................
4. Dr. Burzynski agrees to provide the Company such laboratory & research space as the Company needs at the facility in Stafford, Texas, & such office space as is necessary at Trinity Drive and at his medical facility.
.....................................................................................................
5. In the event the research described in the agreement results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions & limitations as is in the current license between the parties.
.....................................................................................................
6. Dr. Burzynski shall have unlimited & free access to all equipment which the Company owns, so long as such use is not in conflict with the Company’s use of such equipment, including without limitation to all equipment used in manufacturing of antineoplastons used in the clinical trials.
.....................................................................................................
7. The amounts, which Dr. Burzynski is obligated to pay under the agreement, shall be reduced dollar for dollar by the following:
.....................................................................................................
a. Any income which the Company receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income (such as the purchase of chemicals, products or equipment) solely necessary to engage in such other research & development

By Didymus Judas Thomas (not verified) on 09 Dec 2012 #permalink

activity, &
.....................................................................................................
b. The net proceeds of any stock offering or private placement, which the Company receives during the term of the engagement up to a maximum of $1,000,000 in a given Company fiscal year.
.....................................................................................................
8. Effective 3/1/2012, the term of the Research Funding Agreement was extended to 2/28/2013, & is automatically renewable for an additional 1-year term thereafter, unless one party notifies the other party at least 30 days prior to the expiration of the term of the agreement of its intention not to renew the agreement. In addition to the foregoing termination provisions, the agreement automatically terminates in the event that Dr. Burzynski owns less than 50# of the outstanding shares of the Company, or is removed as President and/or Chairman of the Board of the Company, unless Dr. Burzynski notifies the Company in writing of his intention to continue the agreement notwithstanding this automatic termination provision.
.....................................................................................................
Royalty Agreement

The Company entered into a royalty agreement with Dr. Burzynski whereby upon receiving FDA approval for interstate marketing & distribution, the Company agrees to pay Dr. Burzynski a royalty interest equivalent to 10% of the Company’s gross income, which royalty interest shall include gross receipts from all future sales, distributions & manufacture of antineoplastons. Dr. Burzynski will have the right to either produce antineoplaston products for use in his medical practice to treat up to 1,000 patients without paying any fees to the Company, or purchase from the Company antineoplaston products for use in his medical practice to treat up to 1,000 patients at a price of the Company’s cost to produce the antineoplaston products plus 10%. Dr. Burzynski will also have the right to either lease or purchase all the manufacturing equipment located at Stafford, Texas at a fair market price. The Company will also have the right to lease from Dr. Burzynski the entire premise located at Stafford, Texas at arms-length terms & rates competitive with those available in the market at that time, provided that Dr. Burzynski does not need the facility for his use.

The term of this agreement is indefinite & will continue until such time as both parties agree it is not in their mutual interest to continue.
.....................................................................................................
Other Related Party Transactions

Dr. Burzynski owns the production facility located at Trinity Drive. There is no formal lease agreement between Dr. Burzynski & the Company; however, the Research Funding Agreement described above provides that Dr. Burzynski will allow the Company the use of the building. In addition, the Royalty Agreement states that after FDA approval is granted (though approval is not assured) the Company may rent the facility at competitive rates if Dr. Burzynski does not need the facility for his use. The actual facility costs are included in the financial statements as set forth in Note 5. In addition, Dr. Burzynski’s medical clinic performs certain administrative functions such as accounting, & allows the Company the use of some office space. Since May of 2000, Dr. Burzynski’s entire salary is paid through his medical practice & he is not compensated directly by the Company for his services.

The Company has received all significant funding from Dr. Burzynski through either cash contributed to the Company or the payment of the cost to conduct FDA approved clinical trials through his medical practice, as disclosed in Note 1. Following is a summary of the capital contributed & clinical trial costs paid by Dr. Burzynski for the years ended 2/29/2012 & 2/28/2011, respectively.

2012 / 2011
.....................................................................................................
Capital contributed
$503,885 / $505,110
.....................................................................................................
Clinical trial costs paid direct
$6,663,784 / $4,523,355
.....................................................................................................
3. Property & Equipment:

Property & equipment consists of the following as of 2/29/2012 & 2/28/2011, respectively:
Estimated
Useful Lives
2012 / 2011
.....................................................................................................
Furniture & equipment
5 - 10 years
$22,415 / $22,415
.....................................................................................................
Total property & equipment
22,415 / 22,415
.....................................................................................................
Accumulated depreciation
(18,996) / (18,295)
$3,419 / $4,120
.....................................................................................................
Depreciation expense for the years ended 2/29/2012 & 2/28/2011 was $701 & $736, respectively.
.....................................................................................................
4. Employee Benefits:

The employees of the Company & SRB participate in a self-funded employee benefit plan providing health care benefits for all its employees. It also provides for them group dental insurance, short-term & long-term disability insurance, & life insurance. Employees pay pre-tax premiums from $105 to $430 per month depending upon the insurance coverage selected by the employee. Employees can select from 2 coverage plans, both of which have a $500 deductible, & varying out-of-pocket maximums.

Due to stop-loss insurance, benefits payable by the Company are limited to $25,000 per person during the policy year. The Company charged to operations a provision of $342,035 for 2012 & $294,319 for 2011, which represents the sum of actual claims paid & an estimate of liabilities relating to claims, both asserted & unasserted, resulting from incidents that occurred during the year. These amounts include costs related to employees of SRB that have been allocated to the Company.

The Company has a qualified 401(k) plan which covers substantially all employees meeting certain eligibility requirements. Participants may contribute a portion of their compensation to the plan, up to the maximum amount permitted under Section 401(k) of the Internal Revenue Code. At the Company’s discretion, it can match a portion of the participants’ contributions. The Company’s matching contribution was $483 & $478 for the years ended 2//9/2012 & 2/28/2011, respectively.
.....................................................................................................
5. Lease commitments:

Dr. Burzynski leases certain equipment used in the clinical trials under leases maturing in 1 to 4 years. Rent expense incurred under these leases was $164,894 & $91,392 for the years ended 2/29/2012 & 2/28/2011, respectively. Future minimum lease payments for the 4 years subsequent to 2/29/2012 are as follows:
2013 $122,808
2014 32,453
2015 17,268
2016 14,390 / $186,919
.....................................................................................................
In addition, as explained in Note 2, Dr. Burzynski owns the facility used by the Company to perform research & produce its drug products. There is currently no lease agreement; however, the facility’s costs are included in the accompanying financial statements as rental expense. The rental expense is derived from not only utilities & expenses normally incurred by a tenant but also mortgage interest, insurance, property taxes & building depreciation. Rent expense totaled $263,922 & $252,604 for 2012 & 2011, respectively.
.....................................................................................................
6. Income Taxes:

The costs incurred related to the conduct of FDA approved clinical trials incurred directly by Dr. Burzynski within his medical practice are deducted by Dr. Burzynski & are not included in the Company’s tax provision.

The actual income tax benefit attributable to the Company’s losses for the years ended 2/29/2012 & 2/28/2011 differ from the amounts computed by applying the U.S. federal income tax rate of 34% to the pretax loss as a result of the following:
2012 / 2011
.....................................................................................................
Expected benefit
$(2,433,605) / $(1,710,622)
.....................................................................................................
Effect of expenses deducted directly by Dr. Burzynski
2,433,605 / 1,710,622
.....................................................................................................
Other adjustments
165,068 / 77,251
.....................................................................................................
Change in valuation allowance
(165,068) / (77,251)
.....................................................................................................
Income tax expense
$— / $—
.....................................................................................................
The components of the Company’s deferred income tax assets as of 2//9/2012 & 2/28/2011 are as follows:
2012 / 2011
.....................................................................................................
Deferred tax assets:

Net operating loss carryforwards
$159,410 / $325,855
.....................................................................................................
Excess book (tax) depreciation
(641) / (672)
.....................................................................................................
Accrued expenses
7,238 / 5,892
.....................................................................................................
Alternative minimum tax credit carryforwards
42,603 / 42,603
.....................................................................................................
Total deferred tax assets
208,610 / 373,678
.....................................................................................................
Less valuation allowance (208,610)(373,678)
.....................................................................................................
Net deferred tax assets
$ — / $ —
.....................................................................................................
The Company’s ability to utilize net operating loss carryforwards & alternative minimum tax credit carryforwards will depend on its ability to generate adequate future taxable income. The Company has no historical earnings on which to base an expectation of future taxable income. Accordingly, a valuation allowance for the total deferred tax assets has been provided.

The Company has net operating loss carryforwards available to offset future income in the amount of $468,854 as of 2/29/2012. The net operating loss carryforwards expire as follows:
Year ending February 28, or 29,
2013 $52,840
2020 $49,976
2021 $24,116
2022 $67,855
2023 $73,401
2024 $69,394
2025 $13,475
2026 $46,972
2027 $31,220
2028 $7,737
2029 $31,868
.....................................................................................................
In addition, the Company has alternative minimum tax credit carryforwards of $42,603 at 2/29/2012.
.....................................................................................................
7. Equity Transactions:

On 9/14/1996, the Company granted 600,000 stock options, with an exercise price of $0.35 per share, to an officer who is no longer with the Company. The options vested as follows:
.....................................................................................................
400,000 options 9/14/1996
100,000 options 6/1/1997
100,000 options 6/1/1998
.....................................................................................................
The options are valid in perpetuity. None of the options have been exercised as of 2/29/2012.

On 6/1/2009, the Company approved the issuance of 60,000 shares of the Company’s Common Stock as compensation for services rendered to the Company & were fair valued at approximately $9,400. The shares were sold pursuant to an exemption from registration under Section 4(2) of the Securities Act of 1933, as amended, to a single accredited investor & did not involve a public offering.
.....................................................................................................
8. Commitments & Contingencies & Supply Source:

In the ordinary course of conducting business, the Company may be a party to legal proceedings & claims. As of 2//9/2012 the Company does not expect the final outcome of any such matters to have a material adverse effect on its financial position, results of operations, or cash flows.

As described in Note 2, the Company entered a Royalty Agreement with Dr. Burzynski. Under that agreement, upon FDA approval, the Company is obligated to provide Dr. Burzynski the right to produce antineoplaston products to treat up to 1,000 patients without paying any fees to the Company or the right to purchase antineoplaston products to treat up to 1,000 patients at cost plus 10%.

The Company produced antineoplaston products to treat approximately 90 patients during the year ended 2/29/2012 & 35 to 40 patients during the year ended 2/28/2011. Management estimates the current production facilities have the capacity to produce product to treat approximately 1,500 patients per year. There is space available at the current site to expand the facility for increased capacity if necessary.

The Company received approximately 89% of the chemicals used in producing antineoplastons from 1 supplier during the year ended 2//9/2012 & 83% during the year ended 2/28/2011. The Company has established additional vendors to supply these chemicals should there be a loss of this supplier.
__________________________________________
12/8 Comments:
__________________________________________
flip, flippant again Aye?
__________________________________________
Krebiozen, great job of re-posting basically everything I posted. The difference is, you ASSUME (make an ASS out of U & ME) & I don't assume.
__________________________________________
MarkL, nice to-quack! I can tell that Reading Comprehension is not your strong suit.
__________________________________________
Krebiozen, ask Jodi Gold Fenton.
__________________________________________
Antaeus Feldspar, nice tu-quack!
We have something here in America called the Declaration of Independence, The United States Constitution, and the Bill of Rights. I know you don't understand the concept.
I think you're full of Fecal matter.
__________________________________________
Chris, how original! You have shown that you are able to use the same word as flip!! Congratulations!!!
Now if you could only figure out how to apologize!
Hey GLEEVEC fanatic, how it that your fave drug got through trials so fast? Were the required by the FDA to use Radiation as part of their Clinical Trial? If "No," Why Not?
__________________________________________
Marc Stepbens Is Insane, there's a difference between "throwing people underthe Bus," and following the Law.
__________________________________________
12/9 Comments:
__________________________________________
herr doktor bimler, you do know that the U.S. has more people in prison than China or Russia, Right? And SRB isn't one of them.
__________________________________________
Narad, the Big Difference between me & you is that i actually filed my own suit vs. Gub-ment & won, without an Attorney. Sounds like you're vying with Antaeus Feldspar to find out which one of you is possibly more full of excrement.
__________________________________________
flip, what's-a-matter? Lose your sense of humor, or have you ever had one? At least I read "The Fatal Shore: The Epic of Australia's Founding." Did you? Or was the 628 pgs. too much for you?
__________________________________________
Antaeus Feldspar, especially if you can't figure out by now that I'm placing the date(s) my comments refer to since 12/6. Thanks for paying attention!
__________________________________________
herr doktor bimler, the only thing that comes to my mind around here is "tu-quack!"
__________________________________________
Narad, I'm thinking of switching to Anthony Hopkins.
__________________________________________
Chemmomo, I am utilizing Charles Darwin's theory of Natural Selection. But I didn't come from Monkeys.

By Didymus Judas Thomas (not verified) on 09 Dec 2012 #permalink

@DJT - why yes, you managed to cut and paste an SEC filing....so where exactly would that be considered "science" and publication of results in qualified medical journals - oh yeah, and also showing multiple positive results from replication of his results by others?

You don't seem to understand how real medical science operates, but you sure do understand the cut and paste functions on your computers......but again, they aren't the same thing.

Who knew DJT could make me miss Th1Th2 so much? At least her droppings were succinct.

@Agashem - I still can't understand what point he/she/it is trying to make, since almost everything is just "word salad."

That's three. So, folks, Diddums has just admitted that Burzynski's performance of "clinical trials" is just a scam allowing him to sell a treatment without having to prove that the treatment has any real benefit, and Diddums thinks that's okay 'cause Burzynski shouldn't have to follow the rules.

By Antaeus Feldspar (not verified) on 10 Dec 2012 #permalink

I see Diddums doesn't know what plagiarism is either.

By Science Mom (not verified) on 10 Dec 2012 #permalink

DJT, u should stick to watchin things go round in circles real quick, cause this thinking thing, it ain't workin

By al kimeea (not verified) on 10 Dec 2012 #permalink

DJT,

Krebiozen, great job of re-posting basically everything I posted.

Unlike you I put the information into a coherent and comprehensible form and added the information you omitted, such as the methods used to make the measurements i.e. CT, MRI or proton magnetic resonance spectroscopy, and the fact that 97% of Jodi's tumor, as measured by MRI, disappeared between 05/11/00 and 06/01/00, that she had surgery on the tumor on 05/15/00 and that she started Burzynski's treatment on 06/06/00.

The difference is, you ASSUME (make an ASS out of U & ME) & I don’t assume.

You don't need any assistance in making an ass out of yourself, you seem to have an extraordinary talent for it, judging by your performance here.

Would you care to point out what I have assumed, and what alternate explanation you think is more likely?

By Krebiozen (not verified) on 10 Dec 2012 #permalink

S:

What factors would distinguish between between a physician using what they might call ‘off-label medications as treatments’ and a physician conducting studies and trials with the same medications on their patients? If they are using the drugs off-label, and no studies have been done to evidence their effectiveness in a given condition, what’s the difference? If the physician calls them “studies”, would that be relevant?

Well, one major factor is that you cannot prescribe a drug off-label if it actually has no on-label indication. It has to be approved to treat *something* before you can prescribe it off-label. AFAIK, the antineoplastons are not yet approved for any indication. The only way they can be given is as part of an approved trial, or under a humanitarian waiver. The former approach is really the only one applicable to Burzynski's situation.

Off-label prescribing doesn't require a study. However, excessive off-label prescribing may impede studies of the drug for that indication, because who'd enter a study if they can already get the drug through normal channels? So it is controversial from a scientific perspective for that reason. From a medical or ethical perspective, well, that depends on the situation.

By Calli Arcale (not verified) on 10 Dec 2012 #permalink

Just noticed that the troll says he didn't come from a monkey. Really, good reading of evolutionary theory. (snark)

I notice all these posts that say SRB does not publish

He hasn't published the results of the clinical trials he's supposedly been conducting for the past couple fo decades (a summary paragraph in an SEC filing does not represent a clinical study report).

Narad, the Big Difference between me & you is that i actually filed my own suit vs. Gub-ment & won, without an Attorney.

There's also the difference that I actually have some grasp of English capitalization, but I digress. Do go on, as this pro se story promises to be quite amusing.

@Narad:

No, the Big Difference between you and Sir Diddimus is that your posts are legible, relevant and concise.

@Denice

Regarding Gary Null who frighten people away from psychiatric meds for learning disabilities and mental illness in children,

I would err on the side of caution for a few factors: the proponent of psych meds for mental illness in childs was Nemeroff, an MD/PhD who was recipient of both NIMH grant as well as paychecks for promoting psych meds for childs (and numerous other condition) and he also polluted the literature with ghost-written articles and a textbook (for GP). On the other hands, for Ritalin (& other stimulant), I'm not sure either way because most of the proponent seem to be primary grade teachers who have too many pupils in the classroom; are there objective measurement method to determine if a children need stimulant?

Alain

@ Didysquat,

Your post seem more legible and include some data but the big unknown is that we don't know the status of the tumors in Burzinsky patient and also, do they respond to the chemotherapy or the antineoplaston or both; there is no way to know based on your data even thought it may fit the criteria asked by the FDA.

Alain

@ Alain:

Certainly there is over-prescription.
However, woo-meisters like those I survey admonish ANY and ALL usage of meds for any condition including SMI and LD in people of ALL ages.

By Denice Walter (not verified) on 10 Dec 2012 #permalink

@ Denice,

Got it; these peoples takes any reasonable positions and push them to their extreme.

Alain

12/8 Comments:
__________________________________________
Antaeus Feldspar, so you wanna play "3 Questions?"

OK. The only way this is going to happen is if you answer MY 3 Questions as well, which I will pose when I have some time.

Agree?

By Didymus Judas Thomas (not verified) on 10 Dec 2012 #permalink

OK. The only way this is going to happen is if you answer MY 3 Questions as well, which I will pose when I have some time.

You appear to be having yet more difficulties with reading comprehension.

DJT:

OK. The only way this is going to happen is if you answer MY 3 Questions as well, which I will pose when I have some time.

You shall get no where until you answer my one question: post the title, journal and date of the PubMed indexed paper showing that the results of a Burzynski Phase 2 clinical trial showed that his methods were as effective with a direct quote explaining it was as effective for that particular cancer as an approved and conventional treatment like Gleevec is for what it is approved for.

Come on. Do it. It should take you less than ten lines of verbiage to provide that answer.

As Narad alludes to, it's not "3 Questions"; it's a single question which you were given a limit of three comments in which to answer. If you can't even get that much correct, it doesn't exactly give anyone reason to think you have brilliant insights about Burzynski.

I don't think you realize that people who come here are expected to discuss their views like civil, honest, and intelligent adults. One thing that means is that, when people ask you a civil question relevant to the topic of discussion and well within your power to answer, you don't ignore that question in favor of, oh, say, spamming an SEC filing instead. When you do ignore those questions, that's when it becomes necessary to introduce negative incentives to discourage that ignoring of inconvenient questions.

You could, of course, attempt to pose ultimatum questions to me in turn. But in fact it would be rather pointless to do so; I'm not the one who's been dodging questions in the first place, nor Gish-galloping around, nor dragging the same smelly red herring across the trail over and over. If you were to actually ask a reasonable and relevant question, I'd answer it as best I could, but if you were the kind of person who asked reasonable and relevant questions in the first place, we'd never have had to resort to ultimatum questions at all.

By Antaeus Feldspar (not verified) on 10 Dec 2012 #permalink

I repeat from above (in between the copypasta):

I forget, is DJT being *neutral* towards Burzyinski, or not? Because he does seem to be going out of his way to defend him…

@Agashem

Who knew DJT could make me miss Th1Th2 so much? At least her droppings were succinct.

Ramen.

@DJT

The difference is, you ASSUME (make an ASS out of U & ME) & I don’t assume.

Unless it involves what other people do or do not know about history/medicine/law/English language....

Funny how you condemn Dr. Burzinski but then you have no other solution. Its absolutely hysterical.

Its so funny to me that there can be so many brainwashed people who believe everything the government and the media say. Honestly. Wake Up.

Sadly I am wasting my time right now chatting to a bunch of brainless and utterly hopeless bunch of sheep who will know no better. So without further will do, im off. Have a nice day.

12/9 Comments:
__________________________________________
Denice Walter, thank you for your erudite observations, but nowhere did I offer an opinion, just "FACTS."
__________________________________________
Now, if you want an OPINION, in my OPINION the most important "FACT" is that:
__________________________________________
"[n]one of the oncologists who originally diagnosed each patient in the film would agree to go on-camera, or submit a written statement."
__________________________________________
What was Orac's MOTIVATION to NOT post this in the blog post?
__________________________________________
After all, in Orac's 11/29 blog it leads the reader to believe that the goal was to be:
__________________________________________
"reviewing Burzynski The Movie and bringing what attention I can to it."
__________________________________________
Let's analyze Orac's post since it contains a link by selecting "overall just a plain bad movie," to Orac's 11/29 blog.
__________________________________________
Here, the reader learns that Orac prefers to:
__________________________________________
"...concentrate on science much more than moviemaking..."
__________________________________________
Our good Friend flip flippantly flouts his "Conspiracy Theory" that it is my intent to DEFEND SRB!

Whilst I posit that flip is flip-flopping & maybe doesn't understand the grand idea of DEFENDING the TRUTH.

As Jack Nicholson said in the 1992 movie "A Few Good Men," "You Can't Handle the Truth."
__________________________________________
I can sympathize with flip since maybe Jesse Ventura's "63 Documents the Government Doesn't Want You to Read" has whipped flip into a furious curious frenzy!!
__________________________________________
Orac assures the reader.
__________________________________________
"I might even look into a couple of Burzynski’s studies that I’ve read and found to be–well–lacking, to put it kindly."
__________________________________________
To put it kindly, what is Orac's "Review," well-lacking?

(Using Orac's own words.)
__________________________________________
Is it Orac who "certainly deserves a heapin’ helpin’ of not-so-Respectful Insolence, but, oddly enough, hasn’t gotten it. One might even say, he’s been Insolenopenic, if you know what I mean."

(Using Orac's own words.)
__________________________________________
Of course, I can fix that.

(Using Orac's own words.)
__________________________________________
I wonder if Galileo ever let FACTS get in the way of SCIENCE? (Or Orac?)
__________________________________________
We have to give Orac some credit for at least providing a link to the TruthMovies interview with Merola, (by selecting "claims the movie was his idea") after Orac does a fine job of kicking him in the mud underthe proverbial Bus.
__________________________________________
Orac doesn't seem to want to believe him, but maybe Orac is a "Conspiracy Theorist" akin to our Friend flipper.
__________________________________________
Orac advised readers that:
__________________________________________
"[t]he documentary was awful, ...and overall just a plain bad movie."
__________________________________________
Obviously, some people thought otherwise based on the Awards the Documentary.has won & a number of "reviews" of the Documentary.
__________________________________________
Kevin Thomas of the Los Angeles Times "reviewed" the Documentary 6/17/2010. Yet his review is not on the LATimes on-line archive, though articles done the same day are.
__________________________________________
Conspiracy Theory?
__________________________________________
Orac calls Merola a "Propogandist," "He’s a hack," & "a shill."
__________________________________________
Orac, please tell us how you really feel !!!
__________________________________________
For someone who claimed above:
__________________________________________
"...concentrate on science much more than moviemaking...,"
__________________________________________
Orac sure opines a lot about the "moviemaking."
__________________________________________
By the time I got through reading Orac's "Review," I was drained.

(to use Orac's own words.)
__________________________________________
Orac even cites "Quackwatch;" which has an interesting "Legal History," but lets not get side-tracked by that.
__________________________________________
Orac states to the reader:
__________________________________________
"In the movie, little snippets of these reports, key parts of the text highlighted in yellow, are rapidly flashed onscreen, after which they disappear..."
__________________________________________
I have 1 word for you, Orac. "PAUSE."
__________________________________________
There's a "Pause" function you can use; just as you would when viewing Big Pharma adds on TV with their tiny legal medical warnings re their drugs & all their side-effects.
__________________________________________
Orac mentions the "Conspiracy Theory" soup of the "NCI," "Texas Medical Board," FDA," & "Big Pharma," but lets not get sidetracked by that subject-matter either.
__________________________________________
Orac whines & whines & whines about the "moviemaking," instead of the "Science."

(To use Orac's own words.)
__________________________________________
Lets look at the "FACTS," shall we?
__________________________________________
Instead of just linking to an Article about Merola, lets actually "review" what HE said.
----------------------------------------------------------
5/26/2010 in Yes! Weekly.
----------------------------------------------------------
“I just became obsessed with the story,...and the more time I spent with Burzynski, his patients and his story, the more obsessed and excited I became.”
----------------------------------------------------------
"I haven’t had a single audience member approach me after a screening and criticize or question the validity of the information in the film."
----------------------------------------------------------
“There is nothing in the film that is ‘assumed,’ ‘theoretical’ or not backed by the highest of documentation and forensic evidence.”
----------------------------------------------------------
"I have trouble seeing what, if anything, the FDA can possibly say about the film to discredit it."
----------------------------------------------------------
“The only thing perhaps they can do is discredit me — which is usually what happens to directors like me. It’s going to be interesting to see what happens. I am prepared for anything.”
__________________________________________
In the interest of disclosure & transparency, I contacted Merola re his comments.
__________________________________________
6/3/10 in TrustMovies;
----------------------------------------------------------
I'm not really sure how to respond to that one. I made a living in advertising, never really enjoyed it. I sort of got stuck in it, while always wanting to be in TV & Film. This is obviously an attack on my character, while ignoring the subject matter.
----------------------------------------------------------
(Re the 6/1/10 Village Voice "hack" "Yellow Journalism" piece - My OPINION.)
http://en.wikipedia.org/w/index.php?title=Yellow_journalism&mobileactio…

http://en.m.wikipedia.org/wiki/Yellow_journalism
----------------------------------------------------------
As I stated in my press kit, I have always been interested in documentaries that delve into hard truths, I'm a huge fan of "The Cove," "Food Inc," "Why We Fight," "No End In Sight," and so on.
**********************************************************************
Orac - "I have to wonder whether Dr. Burzynski just hired Merola to make an infomercial."
**********************************************************************
Orac, there's your answer.
----------------------------------------------------------
I had originally included many of the opposition in the film, but I cut them for the final running time.
----------------------------------------------------------
For instance, Dr. Keith Black, a famous neurosurgeon in LA was on Larry King last fall sitting right next to Burzynski and waved around those invalid NCI trials as "proof" the treatment doesn't work.
----------------------------------------------------------
i had planned on calling him out on it.
----------------------------------------------------------
Second Dr. Black also claimed that the brain tumor patient he sent to Burzynski died shortly after.
----------------------------------------------------------
Well, the reality is, Jodi Fenton, who is the first patient in my film consulted with Dr. Black before going to Burzynski.
----------------------------------------------------------
Dr. Black told her he was a fraud and a quack.
----------------------------------------------------------
30 days later - Jodi was cured of her brain tumor.
----------------------------------------------------------
Dr. Black fails to acknowledge this.
----------------------------------------------------------
As Jodi said in the film
----------------------------------------------------------
he just wrote it off".
----------------------------------------------------------
I did have the film packed with "opposition", but between running time and meeting the goals I felt I had to meet plus just looking at how absurd the "opposition" is, I decided to cut it.
----------------------------------------------------------
Again, anyone can spend hours reading the opposition.
----------------------------------------------------------
However, I also think that I do show some opposition in the film.
__________________________________________
Orac makes various statements re Antineoplastons:
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
"as a promising new treatment that can do much better than existing therapies with much less toxicity, even though there’s no evidence that it can."
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
"unproven therapy"
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
"The short version of the story behind antineoplastons is that there is no good basic science or clinical evidence to suggest that antineoplastons have any significant activity against cancer."
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
"When other researchers do a trial with his neoplastons, the results aren’t nearly as promising; in fact, the results are pretty much always negative, and significant adverse reactions are observed."
----------------------------------------------------------
Orac -[NOTE: The Documentary Channel has apparently asserted a copyright claim and forced YouTube to take the video down
----------------------------------------------------------
I found at least 7 YouBoobTube links.
__________________________________________
Let's NOT let "SCIENCE" get in the way of "FACTS."
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
1. Wikipedia - Mayo Clinic study found no benefit.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
That was not what the study concluded.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
2/1999

"CONCLUSION: Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy."
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
2. 1/1/1986 - SR Burzynski

Drugs Exp Clin Res, January 1, 1986; 12 Suppl 1: 1-9.
.….…………………………………………………………………………
Historical medicinal use of urine & urine extracts known for centuries in ancient times.
.….…………………………………………………………………………
1897 Research initiated by Polish researcher.
1937 1st modern study of certain substances in urine.
1967 Research began when significant differences noted in cancer patients compared to control group.
.….…………………………………………………………………………
Research programme established for identification of antineoplastic from urine.
.….…………………………………………………………………………
Antineoplastons found to be completely different from certain derivatives isolated from urine by other authors.
.….…………………………………………………………………………
Research of urine led to Antineoplaston A1, A2, A3, A4 & A5, which possessed high anticancer activity & low toxicity.
.….…………………………………………………………………………
1st active component named A10.
.….…………………………………………………………………………
2 Synthetic derivatives of A10 named AS2-1 & AS2-5.
.….…………………………………………………………………………
All antineoplaston formulations submitted for Phase I clinical studies in advanced cancer patients.
.….…………………………………………………………………………
Treatment free from significant side-effects & resulted in objective response in # of advanced cancer cases.
__________________________________________
3. 1/1987- MC Liau, M Szopa, B Burzynski, & SR Burzynski.
.….…………………………………………………………………………
Drugs Exp Clin Res, Jan 1987; 13 Suppl 1: 71-6. PMID: .3569019
.….…………………………………………………………………………
Synthetic Antineoplaston A10 shown to produce promising clinical results, similar to those obtained with antineoplastons derived from urine.
.….…………………………………………………………………………
A10 capable of reducing excessive excretions often associated with cancer patients, boosting levels of antineoplaston.
.….…………………………………………………………………………
Therapeutic partially attributable to antineoplastons, the level of which A10 can help to raise.
.….…………………………………………………………………………
Patient must have certain reserve of antineoplastons to benefit from therapy with A10.
.….…………………………………………………………………………
Patients who responded favourably to treatment with A10 invariably showed an increase of certain levels & decrease of certain urinary excretions.
.….…………………………………………………………………………
Results suggest body, under normal circumstances, is protected by antineoplastons against cancer.
__________________________________________
4. 1/1/1994 - M Juszkiewicz, A Chodkowska, SR Burzynski, M Feldo, B Majewska, and Z Kleinrok
.….…………………………………………………………………………
Drugs Exp Clin Res, Jan 1994; 20(4): 161-7. PMID: .7813388
.….…………………………………………………………………………
Influence of A5 on certain structures.
.….…………………………………………………………………………
Antineoplastons naturally occurring...agents.
.….…………………………………………………………………………
Exist in blood, tissues & urine.
.….…………………………………………………………………………
In clinical trials in advanced cancer, in addition to anticancer activity it was observed that patients suffering from both cancer & Parkinson's disease exhibited marked improvement in parkinsonian... when treated with A5.
.….…………………………………………………………………………
Present study designed to analyse the influence of A5 on certain structures.
.….…………………………………………………………………………
Mice & rats given A5 intraperitoneally at 3 different dosage levels.
.….…………………………………………………………………………
Experiments demonstrated A5 stimulates certain receptors.
__________________________________________
5. 11/1997 - Authors: H Tsuda, M Sata, H Saitsu, K Yamana, H Hara, S Yamada, T Kumabe
.….…………………………………………………………………………
Affiliations: KURUME UNIV,SCH MED,DEPT SURG,
KURUME UNIV,SCH MED,DEPT INTERNAL MED. KURUME UNIV,SCH MED,DEPT RADIOL,
KURUME,FUKUOKA 830,JAPAN.
.….…………………………………………………………………………
Oncology reports, November 1997, Volume 4 Number 6
Pages: 1213-1216
.….…………………………………………………………………………
AS2-1 exhibits certain growth inhibition of human...carcinoma cells in vitro & showed minimum adverse effects in phase I clinical trial.
.….…………………………………………………………………………
Reviewed 2 clinical cases of liver cancer in whom we believe A2-1 was useful as maintenance therapy after TAE & MCN.
.….…………………………………………………………………………
2 patients continued to be in good condition for more than 2 years without limitation of normal activities.
.….…………………………………………………………………………
AS2-1 may be effective & useful as maintenance agent...in patients with liver cancer.
__________________________________________
6. 5 - 6/1998 - Authors: H Tsuda, M Sata, T Kumabe, H Hara, N Eriguchi, Y Sugita, H Nagamatsu
.….…………………………………………………………………………
Affiliations: Department of Anesthesiology, Kurume University, School of Medicine, 67 Asahimachi, Kurumeshi, Fukuokaken, 830, Japan.
.….…………………………………………………………………………
Oncology Reports, May-Jun 1998, Volume 5 Number 3
Pages: 597.- 1197
.….…………………………………………………………………………
A10 & AS2-1 exhibit growth inhibition of cancer cells.
.….…………………………………………………………………………
Observed antitumor responses within 2-3 weeks of combination treatment of...therapy & A10 & AS2-1 in phase I clinical study conducted in Kurume University Hospital.
.….…………………………………………………………………………
Reviewed 3 clinical cases of advanced cancer in which we believed A10 & AS2-1 may be contributing to rapid antitumor response.
__________________________________________
7. 11.- 12/1998 - Authors: T Kumabe, H Tsuda, M Uchida, Y Ogoh, N Hayabuchi, M Sata, O Nakashima, H Hara
.….…………………………………………………………………………
Affiliations: Department of Radiology, Kumabe Hospital, Kurume University School of Medicine, Kurumeshi, Fukuokaken 830.-0011, Japan.
.….…………………………………………………………………………
Oncology Reports, Nov-Dec 1998, Volume 5 Number 6
Pages: 1363-1370
.….…………………………………………………………………………
A10 injection exhibited...growth inhibition of human...carcinoma cells in vitro & showed minimum adverse effects in a phase I clinical trial.
.….…………………………………………………………………………
Reviewed 2 cases of advanced HCC treated with A10 I.
.….…………………………………………………………………………
Both cases showed interesting responses to A10 I.
.….…………………………………………………………………………
1 showed massive coagulation necrosis of tumors after...infusion of A10 I & other showed resolution of...tumor thrombosis with systemic infusion of A10 I.
__________________________________________
8. 6/1/1999 - SR Burzynski
Mayo Clin Proc, June 1, 1999; 74(6): 641-2., PMID: .10377942
__________________________________________
9. 1.- 2/2002 - Authors: H. Tsuda, M. Sata, H. Ijuuin, T. Kumabe, M. Uchida, Y. Ogou, Y. Akagi, K. Shirouzu, H. Hara, Y. Nakashima
.….…………………………………………………………………………
Affiliations: Department of Anesthesiology, Kurume University, School of Medicine, Fukuoka-ken .830-0011, Japan
.….…………………………………………………………………………
Oncology Reports, January-February 2002, Volume 9 Number 1, Pages: 65-68
.….…………………………………………………………………………
A10 & AS2-1 chemically identified & synthesized antineoplastons proven to inhibit cancer cell growth by...inhibiting tumor growth.
.….…………………………………………………………………………
Cases of advanced cancer responded well to combination treatment...with A10 & AS2-1 in clinical trials being conducted in Kurume University Hospital.
__________________________________________
10 4/2003 - SR Burzynski
.….…………………………………………………………………………
Med Hypotheses, Apr 2003; 60(4): 578-83., PMID: .12615527
.….…………………………………………………………………………
Antineoplastons work as...switches, turning inactive tumor suppressor genes back on.
.….…………………………………………………………………………
While they activate tumor suppressor genes, they also activate some additional genes silenced during aging process.
__________________________________________
11. 3/1-2004 - Stanislaw R. Burzynski, Burzynski Research Institute, Houston, TX
.….…………………………………………………………………………
doi: 10.1177/1534735403261964 Integr Cancer Ther March 2004 vol. 3 no. 1 47-58
.….…………………………………………………………………………
Antineoplastons work as...switches, which regulate expression of genes.
.….…………………………………………………………………………
Phase II trials indicate efficacy of antineoplastons in low-grade glioma, brain stem glioma, high-grade glioma, adenocarcinoma of the colon, & hepatocellular carcinoma
..….…………………………………………………………………………
Best results observed in children with low-grade glioma, where 74% of patients obtained objective response, & in patients with adenocarcinoma of the colon...whose survival rate of more than 5 years is 91% versus 39% in controls.
__________________________________________
12. 9/2004 - Stanislaw R. Burzynski, MD, PhD, Robert I. Lewy, MD, FACP, Robert Weaver, MD, Tomasz Janicki, MD, Gabor Jurida, MD, Mohammad Khan, MD, Chymbeelyn B. Larisma, MD, Jaroslaw Paszkowiak, MD, Barbara Szymkowski, MD, Burzynski Clinic, Houston, Texas
.….…………………………………………………………………………
doi: 10.1177/1534735404267748 Integr Cancer Ther September 2004 vol. 3 no. 3 257-261
.….…………………………………………………………………………
Recurrent diffuse intrinsic brain stem glioblastoma multiforme carries extremely poor prognosis & median survival less than 7 months.
.….…………………………………………………………………………
Authors report good results in 40-year-old man diagnosed with glioblastoma multiforme who received antineoplastons.
.….…………………………………………………………………………
Brain tumor diagnosed in 5/1999, & subsequently underwent subtotal tumor resection & standard radiation therapy.
.….…………………………………………………………………………
MRI &...tomography scans documented tumor recurrence.
.….…………………………………………………………………………
Approximately 2 months after completion of radiation therapy, he was admitted for administration of...A10 & AS2-1.
.….…………………………………………………………………………
Administration of A10 & AS2-1 was over 655 consecutive days with exception of few short interruptions.
.….…………………………………………………………………………
Administration was very well tolerated with only mild reversible side effects.
.….…………………………………………………………………………
Follow-up MRI &...tomography scans revealed decrease & eventually disappearance of tumor
..….…………………………………………………………………………
Complete response documented after approximately 1 year of A10 & AS2-1.
.….…………………………………………………………………………
More than 4 years later, off A10 & AS2-1, patient is tumor free, able to carry on normal activities, & works full-time, & KPS increased from 50 to 100.
.….…………………………………………………………………………
Extensive phase II trials with A10 & AS2-1 in patients with glioblastoma multiforme are nearing completion.
.….…………………………………………………………………………
Trials may provide more data regarding efficacy of A10 & AS2-1 in treatment of glioblastoma multiforme in untreated patients compared to results in patients with tumor recurrence after radiation therapy.
__________________________________________
13. 3/2005 - Authors: Keiko Matono, Yutaka Ogata, Hideaki Tsuda, Yasumi Araki, Kazuo Shirouzu
.….…………………………………………………………………………
Oncology Reports, March 2005, Volume 13 Number 3
Pages: 389-395
.….…………………………………………………………………………
Affiliations: Department of Surgery, Kurume University School of Medicine, 67 Asahi-machi, Kurume City, Fukuoka .830-0011, Japan
.….…………………………………………………………………………
Investigated efficacy & mechanisms of AS2-1 against post-operative lung metastasis following removal of implanted human colon cancer in...rat.
.….…………………………………………………………………………
Influence of AS2-1 on in vitro...human colon carcinoma cell activities evaluated.
.….…………………………………………………………………………
AS2-1 administered...after removal of implanted ...cancer in...rat.
.….…………………………………………………………………………
AS2-1 inhibited...cell proliferation through...cell arrest &, at higher concentration, induction of apoptosis.
.….…………………………………………………………………………
AS2-1 showed significant reduction in lung metastasis at 5 weeks & cecal removal.
.….…………………………………………………………………………
Survival rate in AS2-1 group significantly higher than control.
.….…………………………………………………………………………
TUNEL staining on lung...tumors revealed apoptosis index in AS2-1 group significantly higher.
.….…………………………………………………………………………
AS2-1 showed... effect against post-operative lung metastases from...cancer through...cell arrest & subsequent induction of apoptosis.
__________________________________________
14. 6/2005 - Stanislaw R. Burzynski, MD, PhD, Robert A. Weaver, MD, Tomasz Janicki, MD, Barbara Szymkowski, MD, Gabor Jurida, MD, Mohammad Khan, MD, Vsevolod Dolgopolov, MD, Burzynski Clinic, Houston, Texas
.….…………………………………………………………………………
doi: 10.1177/1534735405276835 Integr Cancer Ther June 2005 vol. 4 no. 2 168-177
.….…………………………………………………………………………
13 children, either with recurrent disease or high risk, treated in phase II studies with antineoplastons.
.….…………………………………………………………………………
Median age of patients 5 years, 7 months (range, 1-11).
.….…………………………………………………………………………
Medulloblastoma diagnosed in 8 patients
pineoblastoma in 3 patients.
Other PNET in 2 patients.
.….…………………………………………………………………………
Previous treatments included surgery in 12 patients.
(1 had biopsy only)
chemotherapy in 6 patients.
radiation therapy in 6 patients.
6 patients hadn't received prior chemotherapy or radiation.
.….…………………………………………………………………………
Treatment consisted of...infusions of 2 formulations of ANP, A10 & AS2-1, & administered an average of 20 months.
.….…………………………………………………………………………
Complete response accomplished in 23%,
partial response in 8%,
stable disease in 31%,
progressive disease in 38% of cases.
.….…………………………………………………………………………
6 patients (46%) survived more than 5 years from initiation of ANP.
.….…………………………………………………………………………
5 not treated earlier with radiation therapy or chemotherapy.
.….…………………………………………………………………………
Serious side effects included single occurrences of fever, granulocytopenia, & anemia.
.….…………………………………………………………………………
Study ongoing & accruing additional patients.
.….…………………………………………………………………………
% of patients’ response lower than standard treatment of favorable PNET, but long-term survival in poor-risk cases & reduced toxicity makes ANP promising for very young children, patients at high risk of complication of standard therapy, & patients with recurrent tumors.
__________________________________________
15. 8/2005 - Authors: Teruhiko Fujii, Anna M. Nakamura, Goro Yokoyama, Miki Yamaguchi, Kosuke Tayama, Keisuke Miwa, Uhi Toh, Daisuke Kawamura, Kazuo Shirouzu, Hideaki Yamana, Michihiko Kuwano, Hideaki Tsuda
.….…………………………………………………………………………
Affiliations: Department of Surgery, Kurume University School of Medicine, 67 Asahimachi, Kurume, Fukuoka, .830-0011, Japan.
.….…………………………………………………………………………
Oncology Reports, August 2005, Volume 14 Number 2
Pages: 489-494
.….…………………………………………………………………………
Cells treated with A10 monitored for changes.
.….…………………………………………………………………………
A10 markedly inhibited SKBR-3 proliferation due to arrest in G1 phase.
.….…………………………………………………………………………
A10 down-regulated expression...resulting in inhibition.
increased expression..., with resultant inhibition.
.….…………………………………………………………………………
Study defined pathway in which A10 arrested...cells.
findings indicate that A10 antitumor effect could be utilized as effective therapy for breast cancer patients.
__________________________________________
16. 3/2006 -
.….…………………………………………………………………………
doi: 10.1177/1534735405285380 Integr Cancer Ther March 2006 vol. 5 no. 1 40-47
.….…………………………………………………………………………
Brainstem glioma carries worst prognosis of all malignancies of the brain.
.….…………………………………………………………………………
Most patients with brainstem glioma fail standard radiation therapy & chemotherapy & do not survive longer than 2 years.
.….…………………………………………………………………………
Treatment even more challenging when inoperable tumor is of high-grade pathology (HBSG).
.….…………………………………………………………………………
Objective of report to summarize outcome of patients with HBSG treated with antineoplastons in 4 phase 2 trials.
.….…………………………………………………………………………
Patients: group of 18 patients was evaluable:
4 patients with glioblastomas.
14 patients with anaplastic HBSG.
14 patients had diffuse intrinsic tumors.
12 patients suffered from recurrence.
6 patients did not have radiation therapy or chemotherapy.
.….…………………………………………………………………………
Methods: Antineoplastons, which consist of antineoplaston A10 (A10I) & AS2-1 injections, were given in escalating doses.
.….…………………………………………………………………………
Median duration of antineoplaston administration was 5 months.
.….…………………………………………………………………………
Responses were assessed by...enhanced MRI &...tomography.
.….…………………………………………………………………………
Results: overall survival at 2 & 5 years was 39% & 22%, respectively.
.….…………………………………………………………………………
Maximum survival was more than 17 years for patient with anaplastic astrocytoma.
.….…………………………………………………………………………
More than 5 years for a patient with glioblastoma.
Progression-free survival at 6 months was 39%.
.….…………………………………………………………………………
Complete response was achieved in 11%.
Partial response in 11%.
Stable disease in 39%.
Progressive disease in 39% of patients.
.….…………………………………………………………………………
Antineoplastons were tolerated very well with 1 case of grade 4 toxicity (reversible anemia).
.….…………………………………………………………………………
Conclusion: Antineoplastons contributed to more than 5-year survival in recurrent diffuse intrinsic glioblastomas & anaplastic astrocytomas of brainstem in small group of patients.
__________________________________________
17. 11/18.- 21/2010 - Stanislaw R. Burzynski, Robert A. Weaver, Tomasz J. Janicki, Gregory S. Burzynski, Barbara Szymkowski & Sheryll S. Acelar, Burzynski Clinic
.….…………………………………………………………………………
Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2010
.….…………………………………………………………………………
Neuro Oncol (2010) 12 (suppl 4): iv69-iv78. doi: 10.1093/neuonc/noq116.s9 This article appears in: Abstracts from the 15th Annual Meeting of the Society for Neuro-Oncology (SNO), November 18–21, 2010, Montreal, Quebec, Canada
.….…………………………………………………………………………
Purpose of study was to evaluate efficacy & toxicity of antineoplastons A10 & AS2-1 (ANP) in adult patients with recurrent mixed gliomas.
.….…………………………………………………………………………
13 of 20 patients enrolled were evaluable.
.….…………………………………………………………………………
7 patients could not be evaluated due to inadequate duration of treatment & lack of follow-up MRI scans
..….…………………………………………………………………………
4 women & 9 men.
.….…………………………………………………………………………
Median age was 38 (range, 29–54).
.….…………………………………………………………………………
Median KPS score at baseline was 70 (range, 60–100).
1 patient had low-grade & 12 patients had high-grade mixed gliomas.
.….…………………………………………………………………………
All patients received chemotherapy, radiation therapy, & surgery prior to ANP, with exception of 1 patient who received no chemotherapy or radiation therapy postsurgery.
.….…………………………………………………………………………
Patients received escalating doses of...ANP 6 times daily.
.….…………………………………………………………………………
Median duration of treatment was 4.4 months.
.….…………………………………………………………………………
ANP was well tolerated, with most common side effects being urinary frequency, hypernatremia, dysgeusia, myalgias, nausea, & hypersensitivity.
.….…………………………………………………………………………
Serious (grade 3) toxicity (urinary frequency) was observed in only 1 patient & there were no grade 4 toxicities.
.….…………………………………………………………………………
Response to ANP monitored by MRIs of the brain.
.….…………………………………………………………………………
Responses were as follows:
Complete response, 23%.
Partial response, 8%.
Stable disease, 23%.
Progressive disease, 46%.
.….…………………………………………………………………………
Progression-free survivals (PFS) at 1, 2, & 5 years were 31%, 23%, & 8%, respectively.
.….…………………………………………………………………………
Overall survivals (OS) from diagnosis & start of treatment at 1, 2, & 5 years were 92% & 54%, 85% & 23%, & 46% & 8%, respectively.
.….…………………………………………………………………………
Preliminary results of our small study of adults with recurrent mixed gliomas revealed ANP to be very effective in resolving or stabilizing disease in more than 50% of treated patients as well as encouraging PFS & OS with minimal toxicity.
__________________________________________
18. 9/18.- 21/2010 - Sonali Patil, Stanislaw R. Burzynski, Emilia Mrowczynski & Krzysztof Grela, Burzynski Research Institute
.….…………………………………………………………………………
Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2010
.….…………………………………………………………………………
Neuro Oncol (2010) 12 (suppl 4): iv7-iv25. doi: 10.1093/neuonc/noq116.s2 This article appears in: Abstracts from the 15th Annual Meeting of the Society for Neuro-Oncology (SNO), November 18–21, 2010, Montreal, Quebec, Canada
.….…………………………………………………………………………
In this study, we report the changes in expression of several...glioblastoma cells in response to exposure to AS2-1.
.….…………………………………………………………………………
Using total human microarray screen we noted reduced expression...& enhanced expression of genes involved in apoptosis in...cells exposed to AS2-1.
.….…………………………………………………………………………
Antineoplastons will be used in phase III U.S. FDA-regulated clinical trials this year.
.….…………………………………………………………………………
Once approved, these...derivatives may offer promising treatment in many types of brain tumors.
__________________________________________
19. 9/6.- 9/2012 - S. Patil⇓,S. Burzynski, E.Mrowczynski & K. Grela, Burzynski Research Institute, Houston, TX, United States
.….…………………………………………………………………………
Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2012
.….…………………………………………………………………………
Neuro Oncol (2012) 14 (suppl 3): iii1-iii94. doi: 10.1093/neuonc/nos183 This article appears in: Abstracts from the 10th Congress of European Association Of NeuroOncology, Marseille, France September 6-9, 2012
.….…………………………………………………………………………
In this study we investigated effectiveness of combination of PG...
.….…………………………………………………………………………
PG is used in formulation of AS2-1 .
.….…………………………………………………………………………
FDA granted Orphan Drug designation for A10 & AS2-1 for treatment of gliomas, in 2009.
.….…………………………………………………………………………
12 FDA supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor.
.….…………………………………………………………………………
PB is indicated for treatment of glioma & acute... leukemia.
.….…………………………………………………………………………
PB has been shown to inhibit..., induce differentiation & apoptosis in cancer cells.
.….…………………………………………………………………………
Previous studies in our laboratory have shown the combination of PG &...acts synergistically to inhibit growth of...glioblastoma cells.
.….…………………………………………………………………………
Another published report has shown that PB induces apoptosis in...cancer cells.
.….…………………………………………………………………………
In this study we examined effect of combination of PG with...on.. cell line.
.….…………………………………………………………………………
We found PG causes down-regulation of...in
...cells.
.….…………………………………………………………………………
PG is not toxic to normal cells.
.….…………………………………………………………………………
We describe the novel combination of.. & PB as effective anti-proliferative agents in glioblastoma & medulloblastoma cells.
.….…………………………………………………………………………
Links not included on this post in order that it not be Orac Spam Bot Tu-Quack Blocked.

By Didymus Judas Thomas (not verified) on 11 Dec 2012 #permalink

Drunk again diddums?

Another gish gallop that starts with an incoherent ramble, and then gives us the usual copy/pasta of items found online that ARE NOT RESULTS OF CLINICAL TRIALS, provide no verified or indeed verifiable data and are therefore NOT evidence of efficacy.

Burzynski is STILL a fraud.

I would go and have a lie down if I were you. All this making a fool of yourself must be very tiring.

@hello...

Goodbye, brainless and logic-free troll, you will not be missed, although your stupidity would be amusing.

@djt

Strike one, djt, you still haven't posting a shred of proof, like you have done in all of your posts.

The last DJT entry, in which any pretense that it is talking to anyone other than itself has been cast away like a hopelessly tattered slip, has led me to take refuge in the song stylings of Interröbang Cartel. (Not that it actually "needs more wanger.")

Somehow, with all the important national security concerns over the flu and how we must all get vaccinated, I missed this news. Way to go Stanislaw Burzynski.

@Narad - what the hell kind of formatting is that supposed to be in Didums last post? That isn't even stream of consciousness, unless it's coming from a deranged person's mind......

Didymus Judas Thomas, are you a programmer? That hierarchical formatting looks like the way I used to subdivide assembly language programs. Just a hint for future reference: in programming it makes sense; in text it is bizarre and renders your output unintelligible.

Bo, you might actually try reading the articles you are commenting on. While your sentence now makes grammatical sense, it has absolutely nothing to do with the subject. Burzynski gives dying cancer patients drugs that are much more dangerous than any flu vaccine.

As often occurred with with Th1Th2, this has reached a point where I feel a bit uncomfortable arguing with someone who appears to be unable to conduct even the semblance of a rational discussion.

By Krebiozen (not verified) on 12 Dec 2012 #permalink

@hello

Funny how you condemn Dr. Burzinski but then you have no other solution.

Solution to what, exactly?Iit's true that at the present time there is no cure or effective treatment for some cancers, including the advanced glioma's which seem to make up the bulk of Burzynski's 'practice' (and I do use the term loosely).

Bu surely you're not arguing that until such time as an effective treatment is identified, people offering false hopes of a cure at exorbitant prices should be allowed to prey on desparate individuals when they're most vulnerable at will.

Or are you?

Sigh--blockquote fail. Hopefully i haven't italicized the internet again...

Funny how you condemn Dr. Burzinski but then you have no other solution. Its absolutely hysterical.

The other day I went to the Grand Canyon and realized I was on the wrong side. There was no bridge anywhere around, but I did find a man with a catapult who said he'd get me across for $150,000. I asked if his catapult was safe; he said it was. I asked to see his test protocols and results to see if it was more likely I'd arrive safely, die on impact, or be flung into the abyss; he said it was effective but would not produce the data I looked for.

Should I, or should I not, tell others that there's no proof that this man's protocol is safe and effective?

By Mephistopheles… (not verified) on 12 Dec 2012 #permalink

@hello

Should have been 'goodbye', but I digress:

Funny how you condemn Dr. Burzinski but then you have no other solution. Its absolutely hysterical.

Ah yes, the old "you have no better ideas, so his must be right" trope. No, even if everything we know is wrong, that doesn't make him right.

Its so funny to me that there can be so many brainwashed people who believe everything the government and the media say. Honestly. Wake Up.

Funny, we're the ones asking for the evidence *because* we refuse to believe everything we're told. And yet, it's usually the Burzyinski fans who do all the believing and none of the questioning.

Sadly I am wasting my time right now chatting to a bunch of brainless and utterly hopeless bunch of sheep who will know no better. So without further will do, im off. Have a nice day.

Read: I have no evidence, so I'll go now before you start asking me for it.

@DJT

Our good Friend flip flippantly flouts his “Conspiracy Theory” that it is my intent to DEFEND SRB!

Whilst I posit that flip is flip-flopping & maybe doesn’t understand the grand idea of DEFENDING the TRUTH.

Your reading comprehension still fails you. I said that I didn't know *what* you were trying to achieve. And posted a question in the hopes you'd clarify yourself. Which you have also failed at.

Can you, I don't know, learn how to use blockquotes? It's very easy, here I'll teach you. Before the text you want to quote, put a left triangular bracket, usually found to the right of the letter 'M' on your keyboard. Then type the word blockquote. Then type in a right triangular bracket. Then enter the text you are quoting. To close the whole thing up, add a left triangular bracket, a backslash (the one on the same key as the question mark), type the word blockquote, and then a right triangular bracket.

So it will be like this, but minus the spaces:

Text

Do that from now on and your comments will be easier to read. Maybe people will understand you a bit better...Smaller comments will help too, and less copying and pasting of random stuff. Of course, that won't help with the general word salad, but it will help reduce the confusion.

@LW

Didymus Judas Thomas, are you a programmer? That hierarchical formatting looks like the way I used to subdivide assembly language programs. Just a hint for future reference: in programming it makes sense; in text it is bizarre and renders your output unintelligible.

I know they're not the same things, but surely a programmer can figure out basic HTML?

F*ing... even the spaces converted it to html.

Try again, the blockquotes will be like this:

Text

Darn you wordpress! Ok, use triangular brackets instead of the square ones shown below:

[blockquote] Text [/blockquote]

I think you meant <blockquote> and </blockquote>, but we'll see if that gets through.

By Mephistopheles… (not verified) on 12 Dec 2012 #permalink

@Chris is the fear salesman.

Bo, try full sentences and prove you have read the above article. Where does Burzynski tell patients to not get vaccines?

I'm reminded of some things I've read about Uwe Boll. He sometimes challenges the people who criticize his movies to boxing matches. Other times, he argues along the lines that they should just shut up and make better movies, as if the ability to create good movies is a prerequisite for recognizing and criticizing bad ones.

I don't need to be able to cure cancer to recognize and point out warning signs of a cancer quack.

By Bronze Dog (not verified) on 12 Dec 2012 #permalink

I fear Chris is offended. Can we get a vaccine for that?

@Bo - do you actual have a point or do you just enjoy spamming multiple threads with your inane comments?

Oh wait...I think I just answered my own question....lol

Bo, I am not offended. I am baffled at your bizarre comments. Though they are kind of amusing in an avant-garde dada sense. Kind of like a goth high school kid performing at an amateur poetry reading.

I think bo's point is "Look at me! Look at me! Aren't I so clever?"

I think bo’s point is “Look at me! Look at me! Aren’t I so clever?”

That can't be right—he's really concerned about surveillance.

So, JGC, I see you have also suffered through a high school poetry reading. I was so glad that my daughter had the start time wrong and I only had to sit through half of it.

@Lawrence given the FDA, DOJ, and the Texas Board of Medical Examiners can't seem to refute him, discredit him, or prosecute him, my advice to you would be to stop playing with the chemicals making worthless vaccines for profit.

Be a good boy go outside and play, I promise I won't let the other students bully you anymore,

Answer the questions, Bo. What part of Burzynski has to do with flu vaccines?

ummm.....let see:

1-: insulting
2-: patronizing
3-: spammer

What else? Anyone want to add to that list?

Alain

So, JGC, I see you have also suffered through a high school poetry reading.

Just be glad you're not stuck with the public radio station in the third-largest DMA. Their relentless coverage of teen poetry slams has been going on for years.

@Lawrence given the FDA, DOJ, and the Texas Board of Medical Examiners can’t seem to refute him, discredit him, or prosecute him, my advice to you would be to stop playing with the chemicals making worthless vaccines for profit.

What a perfect example of non sequitur!

How the hell does clause 2 follow at all logically from clause 1?

@Adam - I guess it would be great to actually have "published clinical results" to refute, wouldn't it? I mean, you'd think after 30 years that Dr. B would have oodles of results that could be published to shut us up, right?

Wouldn't it be very easy for Dr. B to just go ahead & publish his "cure" for Cancer, spread it far and wide (via the Internet to avoid Guv'ment repression) and silence his critics once and for all?

Of course, being able to play the victim / martyr seems to be an extremely lucrative business - and if results were ever published that showed his treatment didn't work, it would be the end of the gravy train, wouldn't it?

Who's suppressing Burzynski's test results? Burzynski is. Gee. I wonder why.

Meanwhile, in this Burzynski-induced lack of evidence, we default to the null hypothesis: That his treatments don't work. He's not exactly in a rush to falsify said null hypothesis.

By Bronze Dog (not verified) on 12 Dec 2012 #permalink

FDA, DOJ, and the Texas Board of Medical Examiners can't seem to refute him, discredit him, or prosecute him

Bo, until such time as Burzynski offers evidence in support of his claims that antineoplastons are effective at treating advanced stage cancers by publishing the results of the multiple 'clinical trials' he's supposedly been conducting for the past couple of decades there simply isn't anything which needs refutation.

Bo, Diddums, Mel, Marge and Judith. Guys we should be utterly embarrassed that we are attracting this quality of troll. We can and should do better.

By Science Mom (not verified) on 12 Dec 2012 #permalink

Guys we should be utterly embarrassed that we are attracting this quality of troll. We can and should do better.

How I long for the days of Thingy, blackheart, and the cannabis troll. Truly those were the golden years :)

ummm…..let see:

1-: insulting
2-: patronizing
3-: spammer

What else? Anyone want to add to that list?

Incomprehensible, irrelevant, and inane?

Adam, how could you forget Pegemily?

Bo, Diddums, Mel, Marge and Judith. Guys we should be utterly embarrassed that we are attracting this quality of troll. We can and should do better.

Agreed, it was more fun with Jake, the superstar pediatrics (can't recall his name) and the gardasil in the brain guy whose postdoc is lucija tomlosomething....

Alain

Guys we should be utterly embarrassed that we are attracting this quality of troll.

I have not ruled out the possibility that Bo is actually Suzanne Humphries on a multiday bender.

I have not ruled out the possibility that Bo is actually Suzanne Humphries on a multiday bender.

:D

Agreed, it was more fun with Jake, the superstar pediatrics (can’t recall his name) and the gardasil in the brain guy whose postdoc is lucija tomlosomething….

Well we briefly got the Dumpster Diver Goldman but he got scared off too easily.

By Science Mom (not verified) on 12 Dec 2012 #permalink

Funny how you condemn Dr. Burzinski but then you have no other solution. Its absolutely hysterical.

If someone claims they can turn lead into gold, I don't have to demonstrate the ability to turn lead into gold myself before I can say "this guy's a cheap con artist."

Its so funny to me that there can be so many brainwashed people who believe everything the government and the media say. Honestly. Wake Up.

"Everything"? Isn't it jumping to an awfully big conclusion to think we believe "everything" the government and media says, just because when we compare Burzynski's claims to those of his critics, the critics are far more credible?

Here are some facts for you to consider. You can verify for yourself that all of them are true.

Burzynski has been doing "clinical trials" for thirty years now and still hasn't managed to publish any data from them to prove that his treatments do anything.

Patients who agree to participate in clinical trials - real clinical trials - are almost always paid. They are taking big risks and they are providing an invaluable service to the researchers.

Burzynski, by contrast, expects patients to both provide him with that invaluable service of helping him prove his treatment AND to pay HIM five and six figures. He's come no closer to publishing a single paper in thirty years, but he HAS made millions of dollars this way.

Tell me again why the government and media are LESS credible than Burzynski?

By Antaeus Feldspar (not verified) on 12 Dec 2012 #permalink

One of many reasons to doubt Burzynski's claims:

He did publish a little thirty years ago. He did get some patents. There were some (unsuccessful) tests of his claims; they too were reported. These things are public records accessible to anyone in the world who is interested. And the source for his antineoplastons was urine, a raw material readily available anywhere humans can be found.

So anyone in the world could have picked up the challenge and started testing and refining his protocol. It wouldn't be too expensive for even a small third-world nation -- how do I know? Because Burzynski claims to have done the research on his own dime while siphoning off enough for his lavish lifestyle.

Sure, such research might, initially anyway, infringe on his patents, but so what? America is not the world and American patents do not control in every country.

So why didn't anybody in the world in three decades do the research and come up with a workable protocol? Why aren't there already antineoplaston clinics around the world?

Unless, of course, it just doesn't work.

@MOB

How did you get the blockquotes to work? I tried various ways, but they kept converting.

@Bo

@Lawrence given the FDA, DOJ, and the Texas Board of Medical Examiners can’t seem to refute him, discredit him, or prosecute him, my advice to you would be to stop playing with the chemicals making worthless vaccines for profit.

Hmm, I guess Bo's tactic is to insert the word 'vaccine' into every comment regardless of context...

How did you get the blockquotes to work? I tried various ways, but they kept converting.

You have to type &lt; and &gt;.

@Narad

Ah, of course! Serves me right for forgetting that... Thanks!

Flip,

What Narad said. And, of course, in order to show &gt; you have to type &amp;gt...

By Mephistopheles… (not verified) on 12 Dec 2012 #permalink

@MO'B,

That sound like recursive typing &amp;gt :)

Alain

Also, the blog software hear seems to default to italics for blockquotes. At least it lets you blockquote more than one paragraph, unlike the previous version of software here.

... Um, yes, it should be "software here"!

And to think I was talking about freaking homonyms this morning with daughter. Ah, the joys of the not very phonetic English language.

And for n > 1, all sequences of n instances of the word "police" are grammatically correct English.

the blog software here seems to default to italics for blockquotes.

The blockquote tag enclosed in greater/lesser than signs works fine for me. The closing blockquote tag requires the '/' sign to precede the word 'blockquote', just as MOB wrote earlier.

Most importantly, if I don't force the text into paragraphs with the 'p' in greater/lesser than signs, then it throws off the blockquote tags. I have to use them together at the beginning and end of each paragraph.

I use 'em' in the same manner for italics.

My guess is I can't force a display of the blockquote command, as did MOB. Don't know how he did that.

Test: This is the blockquote command.

and I bet you don't see it.

Narad, you are very special. I have no idea what you are saying. But then again, there is a glass of wine involved.

S, from my cheat sheet:
How to use a blockquote: <blockquote>Put paragraph of person you are quoting in here.</blockquote>

I have never used <blockquote>p</blockquote> here. So I don't know if it works.

And I don't have preview, so I don't know if I screwed up. So I'll just blame lack of sleep and the glass of wine sitting on the nearby table.

Narad, you are very special. I have no idea what you are saying.

Indeed he is. I'm thinking he is Mensa material. I've learned to let some of the stuff he says go right over my head, sorry to admit that.

I meant: <p>Put paragraph of person you are quoting in here.</p>

Must cut and paste the proper words!

And again, I don't know if I did it write, with the usual excuse.

The person being quoted goes in-between the blockquote tag so their quote is indented. I always use the 'p' tags regardless of whether I use blockquote, if I am just writing one line of my own text. It's too late at night for me to think. I'll practice tomorrow.

S, I think Narad is better than Mensa. Much of what he/she says is above my head, but I am good with that. Also I am n