As I contemplated how I wanted to start the blogging week, I thought that I should probably again plug Bob Blaskiewicz's campaign to provide Dr. Stanislaw Burzynski, the Houston doctor who for the last 35 years has been treating patients diagnosed with advanced stage and terminal cancers with something he calls antineoplastons (ANPs), with a most excellent "gift" for his 70th birthday. This he does despite the astounding lack of compelling evidence that ANPs are actually effective against cancer, none of which stops him from charging patients exorbitant amounts of money, sometimes upwards of $100,000, for his "treatments," which he claims to be part of being on a clinical trial. Never mind that, as I've pointed out time and time again, Burzynski has had dozens of phase II clinical trials since the 1990s and has published on precious few of them, and when he has claimed remissions others have not been able to replicate his results. In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy. Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.
In any case, what Bob's trying to do is, as I've pointed out before, to shame Dr. Burzynski into doing something good for cancer patients for a change. He's doing this by challenging skeptics to raise money that will do cancer patients real good, namely to be given as a donation to the St. Jude's Children's Hospital. On Burzynski's birthday (January 23), he'll challenge Dr. Burzynski to match it. If Burzynski actually does match it (highly unlikely given that he has no shame), it will be the first good thing Burzynski has ever done for cancer patients. If he doesn't, at least it will shine the light of publicity on what Burzynski has been getting away with doing for over 30 years. The link to donate is here. So what are you waiting for?
In the meantime, I can't help but wonder about a recent post I saw at a particularly wretched hive of scum and quackery, Mercola.com, entitled Case Dismissed! Texas Ends 15-Year Fight Against Cancer Doctor Burzynski. It's basically one big gloat over how the Texas Medical Board dropped its case against Burzynski in November, shortly before Thanksgiving. It's two months late, but I suppose if you're a quack it's better late than never. It also ignores the way that Burzynski got off, basically on a technicality and by throwing the doctors who work for him under the bus. His slithering away from justice yet again is not in any way an indication that he has been vindicated. It is rather amusing in its timing, such that one can't help but wonder whether Bob's campaign is having an effect to the point where Stanislaw Burzynski and his own personal (but talentless) Leni Riefenstahl by the name of Eric Merola were feeling enough pressure that they felt that they had to respond (and to pimp his upcoming Burzynski sequel). If that's the case, all I can say to Bob is: Good job!
About this sequel, entitled Burzynski: Cancer Is Serious Business, Chapter 2 | A Modern Story (and which I like to call Burzynski II: Antineoplaston Boogaloo or Burzynski II: The Color of Money), Mercola exults:
Dr. Burzynski received much-needed publicity two years ago with the release of Burzynski — The Movie, a documentary about Dr. Burzynski’s remarkable cancer discovery, and how he won the largest and possibly the most convoluted and intriguing legal battle against the Food and Drug Administration (FDA) in American history.
This year, a second film detailing his continued struggles, and victories, is scheduled to be released. As announced in the trailer (see above), Dr. Burzynski is now doing the unthinkable... He is “the first and only scientist in United States history to enter the federal drug approval process for a proprietary cancer therapy without any financial support from the American government, the pharmaceutical industry, or the cancer establishment.”
Uh, not quite. Biotech startups go into the FDA drug approval process all the time without support from the American government. I suppose that you could say that they are par of the "pharmaceutical industry." They are not, however, "big pharma," which is what Mercola is clearly trying to imply. Mercola also parrots the Burzynski line that "personalized gene-targeted cancer therapy" is the wave of the future. Actually, that's not a "line." I do believe that personalized therapy is the wave of the future. The line of BS is that Burzynski is at the forefront of surfing that wave, as Mercola claims:
In recent years, the focus for cancer therapy has increasingly shifted toward individualized gene-targeted cancer treatment — such as that provided by Dr. Burzynski for the past 10 years. A description of how the patient’s individualized treatment plan is devised is given in the second video above, starting three minutes into the video. So, is it any wonder the industry wants to get rid of him in order to protect their own profits and access to research funds?
As an example, in January 2011, the Khalifa Foundation gave a $150 million grant to the University of Texas MD Anderson Cancer Center8 “to support genetic-analysis based research, diagnosis, and treatment of cancer.” In short, personalized cancer treatment is the future of oncology, and the US government has spared no expense in trying to make eliminate Dr. Burzynski from the race — including patent theft...
Because Burzynski's rinky-dink operation is just like M. D. Anderson and Burzynski thinks himself on par with the most brilliant cancer researchers in the world who are pioneering personalized therapy, be it at M.D. Anderson, Memorial Sloan-Kettering Cancer Center, or any of the several NCI-designated comprehensive cancer centers working on developing personalized targeted therapy. No, Burzynski does not understand personalized therapy or genomics, which is why I've referred to his methods as "personalized gene-targeted cancer therapy for dummies," and is full of the arrogance of ignorance to the point of laying down some major howlers about gene0-targeted therapy. Apparently, he thinks he invented the concept, which is truly risible. The odds that any useful new method to use genomics and protein expression profiles to guide personalized cancer therapy will come out of the Burzynski Clinic are about the same as the odds that a new scientific breakthrough in anything will be discovered by a homeopathy—slim and none.
In any case, as much as Mercola is kissing Burzynski's posterior, the whole trailer is one big, fat load of conspiracy-mongering propaganda, not unlike the press release:
For most patients being treated by the Burzynski Clinic today—their advanced cancer itself runs secondary to the constant barrage of skepticism coming not only from their local oncologists—who simply do not understand Burzynski's therapy—but also from their own friends and family who feel their loved ones are not making the correct treatment decisions—even though mainstream oncology has already left many of them for dead.
As this story unfolds, the audience will witness a real-time change of hearts and minds from many doctors and families.
Unlike the first documentary, we have interviewed board-certified oncologists, surgeons, and neurosurgeons for this film who witnessed their patients leave their care to return in great health, after opting for the Burzynski Clinic.
Since the mapping of the Cancer Genome, Burzynski has pioneered an expansion of his therapy that he calls, "Personalized Gene-Targeted Cancer Therapy", where each patient's Genomic Cancer Atlas is mapped, and a treatment regimen is personally tailored for each individual patient—vs. the conveyor belt, "one size fits all" approach that current oncology adheres to. This part of the film will likely be the first time most of the audience will become aware of this new direction.
Due to the slow-moving bureaucratic obstacles of Antineoplastons by the FDA, this new expanded "personalized gene-targeted" direction has allowed more patients who are denied access to Antineoplastons by the FDA to benefit from Burzynski's practice in ways never before thought possible.
Note the framing. There are those nasty skeptics, oncologists, and promoters of science-based medicine who, out of concern for patients going to the Burzynski Clinic, try to warn patients that Burzynski doesn't have the goods. Obviously, according to Merola, they're too stupid, ignorant, or deluded to understand the genius that is The Great Stanislaw Burzynski! Especially those Houston oncologists and Houston ER docs, who are the ones on the front lines who actually have to try to pick up the human wreckage that Burzynski leaves behind with his treatments. Never mind that! Merola will show them! He'll do it using what are, in essence, religious conversion stories, in which the metaphorical St. Paul is knocked off his horse by the sheer awesomeness that is Burzynski, recants his previous skepticism as the "miracle" of antineoplastons and Burzynski's "personalized" therapy is revealed, and becomes a believer. Notice, however, no mention of—oh, you know—anything resembling actual scientific evidence.
It also looks as though Merola is going to amp up the conspiracy theory angle again even more than the first movie. I'm not sure how he will achieve this, given that the first installment in Burzynski The Movie was one-third anecdotes, two-thirds broadsides against the FDA and the Texas Medical Board chock full of conspiracy theories. In any case, I'd love to see what Burzynski and his propagandist have to say about his "personalized gene-targeted cancer therapy for dummies"-approach to personalized cancer therapy, because from what I can tell on his website and publicly available sources, not only does Burzynski completely misunderstand targeted therapy, thinking that working on more genes must be better (here's a hint: chemotherapy works on a lot of genes), but he misapplies very basic knowledge of genomics by using a "one from column A, two from column B"-style mixing and matching of targeted agents devoid of any deep understanding of the consequences.
Let's take a look at the trailer:
The clip starts off with what is very old news, a press conference by the director of the FDA through much of the 1990s David Kessler, being asked at a press conference whether the process of expedited review introduced then for anticancer therapies would speed up the approval of antineoplastons. Clearly, the two reporters asking questions are believers, as they keep badgering Kessler after he says that he doesn't want to focus on any single anticancer agent. We're then told ominously that less than one year after this press conference America's federal and state agencies lost a "fourteen year campaign attempting to permanently revoke Burzynski's medical license" and declares that "Burzynski's victory" resulted in the government abandoning its attempt to "hijack" these medicines. Merola also accuses the government of colluding with one of Burzynski's own scientists to file patents on Burzynski's therapies, listed as patent numbers 6037376, 5635532, 5852056, 5654333, 5661179, 5635533, 5843994, 5710178 (which is the same as 5843994), 5877213 (listed as a continuation of 779744, which was abandoned), and 5881124. Several of these appear to be redundant, being continuations or combinations of other patents. Be that as it may, the researcher to which Merola refers is Dvorit Samid, who is currently Vice President of Medical Affairs at Synta Pharmaceutical and was Section Chief Differentiation Control, National Cancer Institute/National Institutes of Health Division of Cancer Treatment from 1990 to 1995. These patents have mainly to do with phenylacetic acid, which was one compound that Burzynski referred to as AS-2.1, and derivatives mostly as anticancer or differentiation compounds in in vitro systems. One of these patents (5881124) has nothing to do with antineoplastons and is in fact an imaging patent. Maybe it's a typo that Merola will fix before he releases his movie.
Be that as it may, the claim that Dvorit Samid "stole" Burzynski's antineoplaston patents strikes me as rather questionable (at best), given that, first, Samid was not "one of Burynski's scientists" but a section chief at the NCI. Also, using Merola's counting methods, Burzynski himself has four patents on antineoplastons, issued in the 1980s. These include 4,470,970, 4,558,057, 4,559,325, and 4,444,890 and since the 1990s has filed numerous patent applications for antineoplastons for everything from treating cancer using liposomal delivery systems, to treating hypercholesterolemia and Parkinson's disease. What exactly happened between Burzynski and the NCI is difficult to discover, as it is documented objectively in few places but trumpeted around the web by Burzynski-friendly sources. Even a paper analyzing the incident from a sociological standpoint isn't particularly revealing, given that it, too, slants towards Burzynski and was published in a highly dubious journal.
Next up in the trailer is a mention of Burzynski's infamous phase III clinical trial, A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma. What has always been puzzling to me, ever since I became interested in Burzynski and his antineoplastons, is why Food and Drug Administration (FDA) not only continues to let Burzynski set up phase II clinical trial after phase II clinical trial, nearly all of which never accrue enough patients to publish. Indeed, if you search ClinicalTrials.gov for "Burzynski" or "antineoplaston," exclude all the trials with "unknown" status, you'll find the aforementioned phase III trial, a whole lot of trials with "unknown" status, and a trial unrelated to antineoplastons for which a man named Joseph Burzynski appears to be an investigator at one of the sites. If you peruse the NCI website, you can find a very nice summary of the existing clinical trial data on antineoplastons. Of those sixty or so phase II studies, there are only a couple of them published, as is summarized nicely by the NCI:
Antineoplaston therapy has been studied as a complementary and alternative therapy for cancer. Case reports, phase I toxicity studies, and some phase II clinical studies examining the effectiveness of antineoplaston therapy have been published. For the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results.
A more detailed listing of the clinical evidence by the NCI is singularly unconvincing.
One notes that Burzynski's phase III trial, although approved in December 2010, is not yet open to accrual, even though it was scheduled to begin accruing patients in December 2011. In any case, the reason that this is an issue is that Burzynski apologists have been pointing to this study as "evidence" that there must be something to antineoplastons, the rationale being that otherwise the FDA would not have given the trial the go-ahead. Given that there is no good clinical data published by Burzynski that I've been able to find to support a phase II clinical trial, this has puzzled me and other skeptics, at least one of whom suspects that, however he persuaded the FDA to approve this trial, it suits Dr. Burzynski just fine that it has not opened yet. It is a suspicion that I share. Think about it. This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with. If Burzynski actually started accruing to the trial, its results would, by law, have to be posted to ClinicalTrials.gov. An approved but not yet accruing trial is an infinitely better weapon than a trial that accrues and produces no results. It's also interesting to note that this clinical trial includes chemotherapy. In fact, Burzynski uses a lot of chemotherapy.
As for the phase II trials, there are lots of trials listed as having "unknown" status (meaning that their status has not been verified in over two years) but still listed as being "open" as well. There are also several studies listed as "withdrawn." It's a total of 62 trials over the last 20 years or so, and not a single one of them, as far as I and others who have looked at them have ever been able to tell, has produced any useful evidence for the efficacy of antineoplaston therapy. Is it any wonder that many of us suspect that these "clinical trials" are shams designed to get around the orders of the Texas Medical Board back in the 1990s that prohibited Burzynski from using antineoplastons except within the context of being tested in clinical trials?
The rest of the trailer consists of nothing more than the usual Burzynski blather, anecdotes, this time bolstered with two conversion stories involving credulous oncologists who are now apparently Burzynski believers.
One wonders how much they would believe if they read some cases, the stories of several Burzynski patients. For example, there's Wayne Merritt, who spent a lot of money at the Burzynski Clinic before figuring out that he was wasting his money. Mr. Merritt was threatened by a representative of the Burzynski Clinic, apparently because Burzynski didn't like the Merritts' Burzynski Scam site. Or maybe they should look at Denise D., a woman who was working as a temp without health insurance when she developed what sounds like inflammatory breast cancer. She went to the Burzynski Clinic, where she was charged large sums of money. When she managed to get some of the drugs she was being prescribed from the pharmaceutical companies through a compassionate use program, saving her thousands of dollars, the Burzynski Clinic turned around and started charging her a $1,500 per month "case management fee" just to submit refills of her submit refills for the Tarceva, Xeloda, Zolinza, and Zometa. These are all very expensive targeted drugs and chemotherapeutics.
When looking at the human cost of Burzynski's activities, words fail me. Sadly, Wayne Merritt and Denise D. are not alone.
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A description of how the patient’s individualized treatment plan is devised is given in the second video above
I'm going to take a wild stab in the dark here and assume that the first step is to check the capacity of the patient's wallet.
So, is it any wonder the industry wants to get rid of him in order to protect their own profits and access to research funds?
As an example, in January 2011, the Khalifa Foundation gave a $150 million grant to the University of Texas MD Anderson Cancer Center8 “to support genetic-analysis based research, diagnosis, and treatment of cancer.”
So "Attempts to suppress Burzynski" include "giving money to anyone who is not Burzynski"?
Perhaps I am missing something here.
Unsurprisingly, the promoter of that trailer is censoring and removing comments that don't tow the line that Burzynski is some lone pioneer fighting big pharma.
Nice to see that David Icke has come out in support of Burzynski now too. That makes a full house of Uber Quackery loving Fruitloops on his side. He must be so proud.
Got a link?
"Nice to see that David Icke has come out in support of Burzynski now too"
Somebody who has more fortitude than me should go on the Icke forum and start a rumour that Burzynski is actually a reptilian overlord in disguise, "antineoplaston" is actually a mind-control drug and the whole thing is an Illuminati plot to subvert all the freedom-loving new-agers and libertarians who refuse to drink the Big Pharma Koolade.
That should make a few heads explode.
Icke is promoting B. for quite some time AFAIK, here's the most recent link:
http://www.davidicke.com/headlines/78540-dr-burzynski-cancer-is-serious…-
That Icke is in the "cancer quackery" business is not really news, it was e.g. his idea that Brian Haw should try Tullio Simoncinis ridiculous "cure".
I thought cancer in the alt-med world was cured by consuming bi-carb and drinking essiac tea and vegetable juice and taking vitamin C and using homeopathy and a liver zapper and eating apricot kernels. If you're using all these "guaranteed cures", why would you even need Burzynski? Isn't he a bit too "big pharma" to be enjoying support from the likes of Mercola?
ZDoggMD
"I Love It When You Call Me Big Pharma"
http://zdoggmd.com/2012/01/big-pharma/
All ya gotta do is support conventional medicine and Big Pharma will fill your bank account - right?
Psssst:
(you can lie all day with your own conspiracy mongering, but you aren't getting away with the Dvorit bullshit, you fucking hack):
http://burzynskimovie.com/images/stories/transcript/Documents/LettersBt…
http://burzynskimovie.com/images/stories/transcript/Documents/Letterfro…
http://burzynskimovie.com/images/stories/transcript/Documents/Researchp…
http://burzynskimovie.com/images/stories/transcript/Documents/SamidDocu…
http://burzynskimovie.com/images/stories/transcript/Documents/CancerRes…
Well, isn't that interesting. I had noted a pattern: the Burzynski Clinic updates its Clinical Trials section of the website every January. In Januray 2011, there were 5 open trials, a link to the ClinicalTrials.gov site listing the 62 trials (one of which was not his), and a statement saying that the Phase III trial protocol had been approved and they expected it to open sometime in 2011. In January 2012, the page was almost identical, but there was only one trial still open and the phase III trial was expected to open in 2012. Sometime since last Wednesday, the site was updated as scheduled. Most of the page has been scrubbed. There's no mention of any open trials, no link to ClinicalTrials.gov, and no mention of the Phase III trial. (In addition, there had been a second page under the heading, but it's now completely gone)
Does Burzynski have *any* open trials at this point?
@WKV - seems that he keeps telling "patients" that they are qualifying for various trials.....so either he's blatantly lying (most likely) or well, no I'm sure he's lying.
Any chance of showing these two how they were conned? I realize the prospect of losing face may make it difficult fro them to admit, but a "deconversion story" would be very powerful.
So Pssst, you're trying to say Dr. B. is pissed off that the guy at NCI noticed that all antineoplastons are is precursors for phenylacetate, and patented the use of phenylacetate in cancer? One would wonder, if B. was researching ANP for 21 years as described in the first letter you link that he hadn't noticed that.
I think we should start a rumor that they reason cancer patients' urine is depleted in "antineoplastons" is that cancer cells *eat* them, and thus Burzynski's "treatment" amounts to feeding the cancers as much as possible in the vain hope that they will die of overeating before they kill the patient.
Is anyone else having trouble with the link Orac provided to the Twenty First Floor.com?
"Given that there is no good clinical data published by Burzynski that I’ve been able to find to support a phase II clinical trial, this has puzzled me and other skeptics, at least one of whom suspects that, however he persuaded the FDA to approve this trial, it suits Dr. Burzynski just fine that it has not opened yet. It is a suspicion that I share."
Sadly, check out Keir Liddle's Twitter feed. The Twenty-first Floor has been shut down by a quack claiming a DMCA violation. I thought it would be back up by now...
@Orac
Typical. If you don't have the science to back a position, go for censorship! DMCA is so easily abused by quacks and cranks.
Who takes down a whole site over a DMCA complaint? Kind of sounds like it might be time to look for new hosting.
I believe the trouble at 21st Floor started with a "live blood" crackpot named Erroll Denton. Josephine Jones has written extensively about him and his vindictive nature.
Narad,
It's happened before with that site. Most recently a threat from our friends at the cult of scientology. LIbel laws are much tougher in the UK (and here in Canada) so maybe it's libel, not DMCA.
Oh, never mind. I just saw that Orac said it's a DMCA claim.
On a purely artistic level, Eric Merola has got to be the worst narrator I've ever heard in my life. His voice is flat, expressionless, monotonous, lacking of any personality and distracting. I could understand the first "movie" was done quickly but couldn't they have afforded a real narrator for the second commercial with all of Stan's millions? Or maybe no professional narrator would go near the project with a thousand-foot pole?
I suspect it's an ego thing with Mr. Old Navy. Or maybe the premise that he voices it himself "proves" his own sincerity or belief in the project. That works fine for Michael Moore, but Merola is no Moore.
And I HATE the jump-cut/opposite-angle camera cuts he uses, back and forth during the interview clips. Extremely amateur, outdated and also very distracting.
The doctor who takes his glasses off in the promo could have been talking about just about anything. How do we know it's a comment about Stan?
I doubt Merola will be in the running for an Oscar for Best Documentary next year.
MSII,
I believe that's 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".
I should perhaps add that 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.
Oh, the tweet is here. I was confused, as I couldn't find it on Liddle's feed proper.
This is a bit OT. What software, if any, do you use to hide your ip address when reading certain sites so that they don't somehow target you in the future?
Keir apparently published a photo of this Denton live blood quack, which triggered the DMCA claim.
S,
I don't. How can they "target" you, except with banner ads? They have no way to get any e-mail addresses or personal data.
Since I spend so much time on anti-scientology sites, I am constantly seeing scientology banner ads. When I spend time on RI I get ironic banner ads for everything from alkaline water machines to psychics to online chakra tests to MMS ingredients (honest).
Ironic banner ad right now: Fifth Season Financial, a lending institution providing loans to cancer patients. On a Burzynski thread.
Last week after I watched that "enema bear" video I got banner ads for two days for that hippie freak's raw food company.
MSII, I'd have to take this discussion offline. I would like to talk with someone who is an expert in IP analysis.
So, the phase III trials *have* been approved? Or just the protocols?
Good luck to Bob B -- as Orac pointed out, Burzynski is shameless.
About the Japanese hematologist *Masakazu Sawarnobori, who was seen on the trailer with Burzynski' (3:40 minutes in), stating (about targeted gene cancer therapy):
"The method is very safe and also very effective, so I'm sure that this is the new strategy for cancer treatment"
* Dr. Sawanobori also attended the "Australasian College of Medical Nutrition meeting, 2010.
http://www.nutritioncollege.org/node/84
Apparently, Josephine Jones has also removed a photo, explicitly citing a DMCA notice. This is very peculiar, as all one has to do is link to the photograph and there is no copying. This is Ticketmaster v. Tickets.Com.
Here's a comparison of the old language vs. the new language on the Burzynski Clinical Trials page. [Items italicized and in square brackets] are removed, whilebolded items are new.
[Introduction to]What are Clinical Trials?
Clinical trials (also clinical research, clinical studies) are research studies to determine whether experimental treatments, or new ways of using known therapies, are safe and effective. Carefully conducted clinical trials are necessary to find treatments that work in people and ways to improve health.
There are four phases of clinical trials in cancer treatment:
Phase I trials: to determine the safety of a new treatment
Phase II trials: to determine whether a certain kind of cancer responds to a new treatment
Phase III trials: to verify whether a new treatment is better than standard treatment
Phase IV trials: to find more specific information about a new treatment that has been already approved for use in patients
[Antineoplastons - Subject of Clinical Trials
Antineoplaston treatment is an experimental therapy offered by the Burzynski Clinic, currently available only within clinical trials.
Currently, there is 1 open clinical trial on Antineoplastons (as of January 2012). The clinical trial is registered with the FDA and result of the trial is reported to the FDA on an annual basis.
Read more about Antineoplaston Therapy]
Quality Control
Clinical trials conducted in our Clinic are FDA approved protocols. A protocol determines what will be done in a clinical trial and why. It outlines how many patients will participate in a clinical trial, type and frequency of medical testing, treatment plan, monitoring requirements and the evaluation plan. [Our staff physicians strictly follow the protocol and submit periodical reports on the progress of the study for FDA evaluation.]
Enrollment in Clinical Trials
The clinical trials encompass a variety of brain tumors in both children and adults. [Over the last ten years more than 2,000 patients have participated in the clinical trials on Antineoplastons.] Only patients eligible to enroll in clinical trials may receive Antineoplaston treatment under the study. [Ineligible patients may receive approval to enroll, from the FDA on an individual basis.]
To find out if you qualify for enrollment in clinical trials, please contact our Cancer Information Specialist.
[The list of open clinical trials is available at Clinicaltrials.gov (the FDA official clinical trials data bank). For the most recent information please contact the Burzynski Clinic directly.
Reports/Statistics
The official reports on the progress of the clinical trials on Antineoplastons are presented regularly by Dr. Burzynski and his associates at various medical symposia and conferences. Mid-term reports from the clinical research are regularly published in peer-reviewed journals and subject-related scientific books.
View the most recent scientific publications.
Latest Developments
Clinical Trials: Antineoplastons in Treatment of Brainstem Glioma
Orphan Drug designation
In September 2004, the FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of Brainstem Glioma. The Orphan Drug designation has been extended to all Gliomas
The FDA's orphan drug program is intended to encourage research, development and approval of products for treatment of diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.
Orphan drug designation enables the Burzynski Research Institute to apply for assistance from the Office of Orphan Product Development in guiding the drug through the regulatory approval process.
Phase III clinical trial - Brainstem Glioma
The protocol for the Phase III trials is ready. Phase III trials are expected to start in 2012.
Last Update: January 2012]
S, understand that there has to be a path from the server you're looking at to your machine in order for it to know where to send the packets. You thus have to use an indetermediary. On the odd occasion where I want to prevent my IP from being registered by a site, I use the JonDoFox Firefox extension, which also requires the JonDo application. If you're not getting into any sort of mischief, this should be adequate, and it alleviates the need to explicitly dork around with proxy settings. It is, of course, going to be slow. If you want stronger anonymity, you're going to have to resort to Tor.
(Note that these are free options; I'm not going to pay someone for the service.)
WKV,
That's quite a difference you found--good work! So even the clinic has removed all references to the fictional, mystical, magical, mythical Phase III trial on its website.
Just to wrap up this anonymity bit, it appears that the Tor Project has significantly ramped up its game since I last looked into it. I would suggest that S check it out. Do not use without understanding the instructions and warnings.
(The noninfringing nature of using <img> tags, the only thing left after Ticketmaster, is further reinforced by the 9th Circuit in Perfect 10 v. Google. If this was the construction, as opposed to re-serving the image, any hosting company worth its salt would have invited Erroll Denton to snort some live taint.)
If anyone frequently requires internet anonymity and a decent speed, I suggest a paid VPN which will cost only a few bucks a month.
In this case, though, the VPN provider knows your identity, and if the connection is encrypted, you're going to see a performance hit all the same. (For a while I had to try to pump X11 through an encrypted VPN as a result of stereotypical IT cluelessness.) Moreover, you're always going to be seen to be coming from the public side of the VPN. With Tor, no intermediate node should be able to determine both ends of the connection.
They've also removed direct references to "antineoplastons" on quite a few pages. The publications page is the only one where that word appears. There are some references to peptides (which are obviously his antineoplastons), but it now reads as background, rather than active treatment and advocacy.
Here is a link of a patients documented medical evidence regarding Antineoplastons efficacy.
www.shontellehiron.com
Um, yeah.
WTF? Does "sit on" mean something else in the Antipodes?
Um, yeah, what?? Narad minded.
LOL!! Just goes to show you know squat! That was a 30 second look at the site...and thats the best you can come up with... WTF!!
@TruBlu, if there were no reported cases of recovery after treatment with antineoplastons alone, this would be easy. But there are some.
Now, here's the problem. We do not know what percentage of patients recover and have long-term survival because Burzynski does not publish that information. Look above in this comment thread: Burzynski used to brag that "Over the last ten years more than 2,000 patients have participated in the clinical trials on Antineoplastons." That is in addition to some 3,000 prior to 1998 and whatever number between 1998 and 2002. So we are talking about over 5,000 patients. Out of that many, some number survived long-term but we don't know how many. Five? Fifty? Five hundred? Who knows? Well, Burzynski knows but he's not telling.
Now, suppose antineoplastons really cured some percentage of these patients. What were the characteristics of these patients? How were they different from those who were not cured? How was their treatment different from those who were not cured? If we knew these things, maybe it would be possible to devise a treatment regimen that has a good chance of working for certain subsets of the patient population. Only we don't know these things because Burzynski doesn't publish the results of his sixty-some clinical trials.
Do you see why just pointing to a surviving patient -- or even a few surviving patients -- isn't really helpful in evaluating Burzynski's purported treatment?
Invited to, but did not actually, sit on the IRB? (BTW, there is no IRB registered with OHRP called "Houston Institutional Review Board". There are several University of Houston IRBs registered, but nothing by the name she lists.)
I also noticed some cherry picking and selective quoting on her "Spin v. Truth" page to make chemotherapy/radiation sound not only risky (which, let's face it, is true...but the risks are generally outweighed by the benefits), but useless. It also ignores the fact that Burzynski uses chemotherapy.
And perhaps, TruBlu, since you are such a supporter of Burzynski, you could help us understand why he charges so freakin' much for drugs from the pharmacy he controls? Or why he charges subjects to participate in clinical trials? Or why he has not published the results of completed trials? Or why his Phase III trial has yet to accrue a single subject?
@Todd W.
Or why his Phase iii trial now appears to have sunk without a trace.?
@S
Tor. The EFF's Onion Router project. Probably the best proxy system for your needs, bar none. There are some theoretical attacks against it, but they are the kind of attacks it takes No Such Agency level resources to execute.
It's a little slow, but it's become so easy to set up there's an Android app for it.
(Speaking from I.T. for 20 years. InfoSec for 15)
Does “sit on” mean something else in the Antipodes?
Invited to sit on the Houston Institutional Review Board (IRB)
Someone left out the 'h'.
I wonder how much this reverse-turn on Phase III will affect the Merola commercial. Isn't that one of the centerpieces of the sales pitch? In the trailer, Merola's own annoying, toneless, amateur voice says something like "no other mortal human, ever on the planet, has entered Phase III trials without any funding...." blah blah blah.
I agree we should now ask the Stanbois to "show us on his website where it says there's a Phase III trial. Nope, sorry, you lose, it ain't there..."
Is it out of the realm of possibility that the FDA simply doesn't want to deal with these litigation-happy hacks? We all saw what happened when Burzynski unleashed his hounds on various critical bloggers (including mine host) and perhaps, given the budget cuts that the FDA has suffered recently, among other things, they simply don't want to deal with the court fees involved. You know these idiots are going to sue to keep their trials open, and I daresay they have deeper pockets than the FDA.
It is an awful commentary on the effectiveness of the FDA if this is in fact the case. But this is just speculation. I'm afraid I'm caught between the FDA being incompetent (allowing the trials to stay open in good faith) or conniving (above scenario).
I'm sure I'm missing a few bits of information; I'm not an expert on the FDA approval process, so I don't know if my ideas are even plausible.
The FDA has a budget of around $4 billion, and such a case wouldn't survive summary judgment. What's the basis? That failure to approve a new trial was capricious? This has been going on for decades. I commend to your attention the escapade that KV Pharma had trying to sue them last year.
@Kelsey - it isn't a question of money, so much as personnel. The FDA is critically understaffed for the work that it has to do, so unfortunately, they have to pick and choose their battles - and given the recent food safety scares, somebody like Dr. B just doesn't rate very high on their list of priorities....which totally SUCKS!
I'm tempted to send a letter to my Congresswoman, to see if she might make an inquiry to the FDA regarding the status of their investigations into Dr. B....see if that doesn't shake a few feathers loose. Long shot, but if you get politicians involved, it sometimes does some good.
@Lawrence: "Long shot, but if you get politicians involved, it sometimes does some good."
At the risk of arguing with my alter-ego, I suspect that some politician is already involved in protecting Burzynski. Perhaps I'm just cynical.
@LW...thankyou. You obviously are looking for answers and not really attacking the messenger like Narad minded. He has shown his colors.
Now to address the issues of your question. I must point out first, that the website link is about my case history.
To answer your points, I can only only offer the truths that I have experienced over the past 2 decades.
Why does Burzynski not publish patient responses?
When we researched antineoplastons, guess what, all the information on skeptic sites was exactly the same speak as exists today. If I had adhered to, or believed the skeptics information verbatim, I would not be speaking to you now. Yes, you will not be able to get the information you think that will prove the worth of antineoplaston treatment. To understand why Burzynski brags about all the thousands of people he has treated, is because he has! For two decades I have not attempted to become involved in the diatribe that exists on sites like this, because it is to no avail. I think, that is the way Burzynski sees it also. In 2001, I was invited to one of Burzynski’s patients reunions. There were over 500 patients from all over the globe that attended. Now, if you can imagine that many patients turning up, would it not be a good snapshot of the efficacy of Burzynski’s work!!!
The characteristics of these patients?
The first thing that comes to mind about the 500 patients I had met and conversed with at the reunion, was their euphoria of still being alive. One women I spoke to, had the antineoplaston treatment back in 1986.
The main characteristic ingredient that my doctors agreed on unanimously, was the fact that I did not breech my immune system with standard cancer treatments, enabled antineoplastons to weave it’s directives and deliver a result that they called outstanding.
Your last point....only we don’t know these things?
I agree you don’t know these things. You don’t have to knock yourself out about it, WHY......
Because the Therapeutical Goods Administration (TGA), Australia’s equivalent to the FDA has reviewed an ‘Executive Summary’ of Data from the FDA on antineoplastons, presented by Burzynski. The outcome of review was... the TGA awarded a ‘Green Light’ for go ahead to present a Full Data Package and NDA towards registration for marketing in Australia.
Would this not been seen as an excellent confirmation of Burzynski’s work.
Or would our Institutions be full of crackpots, charlatans or mules for big Pharma?
Because the Therapeutical [sic] Goods Administration (TGA), Australia’s equivalent to the FDA has reviewed an ‘Executive Summary’ of Data from the FDA on antineoplastons, presented by Burzynski. The outcome of review was… the TGA awarded a ‘Green Light’ for go ahead to present a Full Data Package and NDA towards registration for marketing in Australia.
There is no sign on the Therapeutic Goods Administration's website of any such "Executive Summary" or "Green light", or indeed anything about Burzynski or antineoplastons. Nothing. Bupkis:
http://www.tga.gov.au/
Nor is there anything at the database at the Australian Register of Therapeutic Goods (ARTG):
https://www.ebs.tga.gov.au/
Perhaps you could be more specific about your claims?
Yes, you will not be able to get the information you think that will prove the worth of antineoplaston treatment. To understand why Burzynski brags about all the thousands of people he has treated, is because he has!
The best way for Stan to "brag" about the "thousands of people he has treated" would be to, you know, maybe publish something.
why Burzynski brags about all the thousands of people he has treated
Call me old-fashioned, but I am more interested in the proportion of those thousands who have benefited from that treatment; and whether it is larger than the proportion of people who benefited from non-Burzynski treatment.
Burzynski has that information -- because everyone is supposed to be part of a clinical trial -- but is suppressing it.
@herr dokor bimier
An Executive Summary is a prelude to the lodgement of an NDA. Until the NDA has been lodged, nothing will show up on the TGA website. I think it would be TGA protocol that determines that. I have never seen anyone’s ES listed on their website and as to the Australian Register, antineoplastons will not show up, simply because the TGA has not evaluated the Full Data Package yet, for it to be registered and listed.
In front of me however, I have an email from the Head of TGA Evaluation Team, who gave the Green Light for go ahead to lodge the NDA, updating me on the status of Burzynski’s ES.
If you are just assuming a quick look at the TGA website justifies your response, you either take my word for it, or send and email to the Head of Evaluation and request the information direct...this is my advice to you. You can gain more insight about my claims from the man himself.
I am not here to do your work for you. Best you hone your skills as an investigative skeptic.
One more thing....it is not an easy task for anyone to get a GL for go ahead, ask big Pharma, they will tell you!!!
@Marc Stephens Is Insane.
I see it like this, Burzynski’s Antineoplastons just might be the Second Choice in cancer treatments to level the playing field, so people can decide what best suits them. Antineoplastons is the only drug on the horizon so far, that is close to being registered. It has shown efficacy and we have a chance to get it registered in Australia and give the man a fair go. At the moment, not everyone gets a response, same as chemo & rad, but if a widening of co-operative research prevails, Burzynski’s work might lead to a non toxic choice, that just could be the real deal. Conventional treatment has been at it for 80 odd years, billion of dollars spent, millions of deaths, resulting in a complete failure to come up with the answer. To me, this indicates we all should get behind Burzynski and lets see if he can come up with the goods, we are all dying to find out.
A fair go? After 35 bloody years?!!! How long does he need?!
Non-toxic? Read the horror stories about side effects, some near lethal, on The OTHER Burzynski Patient Group site.
@Marc Stephens is Insane!
Go to the mouth source and get the real answers! If your going to reply to me, reply with solid evidence and documented statements in you fist, as I have done for you, other wise Im not prepare to debate anything because its all hearsay. Go to some other site where your expert intellectual contributions will be appreciated!
@TruBlu, have you noticed the comments indicating that Burzynski has been scrubbing information about antineoplastons from his website? Why would he do that if they worked as claimed?
@TruBlu, let me explain my opinion of Burzynski.
It is possible that antineoplastons do work, for certain cancers under certain conditions, though we do not know that for sure, nor do we know the cancers or the conditions. You are a success story, but we know there were many failures. What's the difference?
If Burzynski published his results, other physicians around the world could study them, could try to tease out the factors that made you a success and others not, and maybe they could come up with a treatment with a much higher rate of success. With some 5,000 or more cases, and sixty to seventy trials, there is a lot of information that scientists the world over could be poring over.
Only Burzynski will not publish, and that makes him lower than pond scum in my eyes.
@TruBlu
Thanks for your comment, but you didn't really answer the questions asked. Here they are again:
* Why does he charge so much for drugs from the pharmacy he controls?
* Why does he charge subjects to participate in clinical trials?
* Why has he not published the results of completed clinical trials despite at least 30 years of supposedly running them?
* Why has his Phase III trial (which is no longer listed on his web site) yet to accrue a single subject?
He publishes selected cases, but nothing about completed trials. If his antineoplastons actually worked, publishing the results of his trials would benefit a lot of people and advance the knowledge of cancer treatment. It might even get him some financial backers to support expanded trials.
Finally, your use of the term "NDA" seems odd. That is an FDA term and not one regularly used by TGA, except in reference to US FDA drug approvals. At any rate, I imagine that Burzynski will have a rather hard time getting antineoplastons approved in Australia, since approval requires actually completing Phase III clinical trials, which he has yet to even begin enrolling, despite his one phase III trial having been registered 3 years ago.
@Todd W.....I understand what your saying, but please understand where I'm coming from. My focus is on the Australian campaign for a Second Choice in cancer treatment.
I wouldn't have a clue about the business acumen, practices or documented evidence on any of the 4 points you have raised. I didn't do the chemo, I was not apart of a Clinical Trial, I fell outside of the age limits, had I fallen into the age bracket, Burzynski would have funded me for free, but as an Act of Grace for my doctor initiating the 1995 NCI trials at the Princess Margret Hospital, Burzynski funded the rest of my treatment for free. READ the documentation on my website.
Come on guys, do a little research, using a bit of common sense would help.
To be apart of any debate, I have to ensure I have my facts insitu, obviously to give me credibility to my arguments, otherwise it leaves one vulnerable. This is why I cannot offer a reply. Have you ever asked Burzynski, ever been to his clinic to get the facts, visited his laboratory, well this is where I would start first. Been there, done that.
As to your point on the NDA....you’re completely off target. I would suggest you contact a TGA Regulator, they will clearly advise you about this point........again, you have failed to present facts to me.
The 'off the cuff' remark you have added about approval in Australia, lowers your credibility, status and aligns you with the inept clowns, who proliferate debating sites. What if I asked you to attend a Q&A debate on National Television, would you accept without a handful of evidence to back your claims? Burzynski has accepted. Isn’t that interesting......
@TruBlu - how about you go over and read "The Other Burzynski Patient Group" website and let us know how you feel about that....
@LW.....Gee, I thought we were going to have a good argument on the fors & against of Burzynski’s, but you have let yourself down and jumped into that pond.
What is it with you. You change your mind like your underpants. Burzynski does not have to prove his worth by posting anything in Peer Review mags or anywhere, if that is what your saying. I wouldn’t.
If I held patents that could change the paradigm of the current cancer merry-go-round, I would not be looking to advertise it, until I finally got the product registered..Hence, this develops a conspiracy plot in the minds of skeptics.
I pointed out in one of my posts that the only Peer Review required to substantiate his work, would be an evaluation of Data by an Institution full of the best scientists and doctors, Australia has. They are given a mandate to make sure the drug shows efficacy and is safe for public consumption. If they get it wrong, heads roll and hell breaks out in the community. Does that not sound like the best recommendation you could get...
What’s the difference?
LW...Try asking the website administrator, I’m sure Burzynski is not on his laptop scrubbing away, put the question to the source, go and interview Burzynski as well, the FDA included and you might find out the answer. It means nothing until you have a statement.
Give me a break!
TruBlu,
I have looked at the documentation on your website, and it seems there was some disagreement as to whether you had a malignant astrocytoma or a benign tumor. Given your previous history of 4 years of partial complex seizures a benign tumor seems very much more likely. There is a report of a craniotomy during which the tumor was removed, "as far was deemed to be safe, the limitations superiorly being the middle cerebral artery".
I am very glad that you recovered so well, but it seems likely that this was a benign tumor, most or all of which was removed surgically and that your recovery had nothing at all to do with antineoplastons.
Hence, this develops a conspiracy plot in the minds of skeptics.
You're (note the spelling) the one posting conspiracy crackpot films and links to Mercola and "Cut, Poison Burn" on your website. You're the one using terms like Big Pharma and claiming there's an organized campaign by the FDA against Burzynski. You're the conspiracy theorist, not us.
You have no idea how the world of science literature works. Stan hasn't published anything because he's a greedy, self-centered narcissicist.
And how's your business going selling that overpriced useless garbage like oxygen chambers and vitamin therapies to other suckers?
http://www.gmdu.net/corp-297034.html
How's it going selling all that useless, expensive
Pro-tip: there are no references to ANPs any more on the Burzynski website because the FDA forced him to remove all false claims. Now maybe you should spend some time reading this blog and the other threads here about the FDA letter in November and the changes Stan has had to make to his website.
@TruBlu - if Dr.B publishing his work for peer review and replication, two things will happen:
1) His treatments are the miracle that he claims them to be, Dr. B becomes world famous, incredibly wealthy (even more so than he is now), wins the Nobel Prize and goes down in history as one of the greatest doctors / scientists of all time.
2) His treatments are actually a sham & don't do anything (or are actually much worse / toxic) - there is potential criminal prosecutions for fraud & of course, law suits from all of his past patients (the ones that are still alive, that is). Even the best case is that his clinic is probably shut down or closes due to lack of business.
Now, given that #1 leads to international fame and immortality in the history books & all of Dr. B's supporters are so sure that his treatment is exactly what he says it is, why aren't you pushing him to publish (especially since you are a "survivor" yourself?)
In not doing so, you are denying what could be a revolutionary Cancer treatment to the masses & allowing thousands, if not tens of thousands of individuals, including children, die because his treatment isn't widely available (because it hasn't been reviewed or even published)......
Of course, if the answer is #2 - you are supporting a con man who has done nothing for the last 35 years but string people along & empty their bank accounts.
So, if Dr. B isn't publishing - it doesn't make a whole lot of sense given the rewards of result #1, unless he is avoiding the consequences of #2.
Your thoughts?
@TruBlu
Technically true, but it would really help his case if he did. Not in the least that it would help him find people to fund the clinical trials necessary for him to get his drug approved.
And speaking of approval, he's supposedly been successfully treating patients with antineoplastons for over 30 years, and yet still no approval from any regulatory agency. "Isn’t that interesting……"
Let's lay out some facts. Antineoplastons are not approved. That means he cannot market them for the treatment of any condition, which means the only way he can get patients using them is via word of mouth. Approval would allow him to market it, meaning an increased income. Publishing the results of his clinical trials in peer-reviewed journals would also provide evidence that there's actually something there (if, indeed, there is anything). That would promote support for his drug among the scientific community. Yet, or so it seems from your portrait of him, he doesn't do that because it might mean he could lose income. So we're back to getting approval, which he refuses to do.
We are left with only limited conclusions to draw. 1) His antineoplastons work, but he's hiding the evidence necessary to truly support that conclusion, which means more people suffer unnecessarily. 2) His antineoplastons do not work, in which case he is hiding the fact as long as is possible so he can continue bilking people out of their money.
(As an aside, I have training in regulatory procedures in the U.S., so my comments about the process are not "completely off target". While I did learn a bit about TGA procedures, my knowledge is admittedly limited in scope. I have, however, put in an inquiry to the TGA and await their response.)
What's ironic is that most Burzynski fans point us to all the bogus literature and meaningless papers that are available as "evidence" that Stan has indeed published. TruBlu, on hte other hand, is taking the opposite tack and admitting Stand has never published anything of worth. "But he doesn't NEED to!," she argues.
Since she sells all that quackery itself, it's not a surprise she supports other charlatans who sell expensive treatments without any documentation.
Please ignore typos and misspellings in previous posts. My display is in safe mode again and it's hard to view and/or edit text this way.
The final total for the Burzynski birthday challenge was $13,500--congrats to Bob B. for raising a nice chunk of change going to real cancer research. A bit short of the $30K goal but $13.5K is about what it costs a Burzynski client to open the front door at his clinic.
Anyone know if there's been any response to the challenge from the great man himself on his 70th?
Burzynski's worth isn't what's being questioned: it's the scientific claims he's making regarding antineoplaston efficacy and safety in treating advanced cancers.
The only meaningful response to that questioning is the publication of all results from the multiple (> 60) clinical trials he's supposedly conducted over the past few decades.
Why? You hold the patents--what additional intellectual protection would you accrue on registration?
Until and unless he publishes the results of the clinical trials he's been conducting, demonstrating safety and efficacy of antineoplastons as treatemtn for advanced cancers, his work can't be substantiated. It isn't that his work hasn't successsfully survived peer review, but that there he's offered nothing to be reviewed in the first place.
Why are you offering a recommnedation, when you're being asked for evidence?
Seems to me that TruBlu doesn't know what is commonly meant by "conspiracy theorist." It's an issue of scale. It's common for groups of people conspire to commit crimes, fraud, deception, and so on. That's why conspiracy is something the legal system can charge suspects with. What separates the standard quack conspiracy like Burzynski's from the realm of "conspiracy theorists" is scale. Small conspiracies are generally easier to pull off, so a conspiracy involving a few quacks is not inherently implausible, and thus not deserving of ridicule on the basis that it involves a conspiracy.
"Conspiracy theorist" connotes belief in world-spanning conspiracies involving hundreds of thousands or even millions of people, which means a large number of potential failure points as well as a bureaucratic and logistical nightmare to maintain secrecy. The large scale is what makes it so implausible and worthy of ridicule.
We aren't claiming that Burzynski is up to anything so huge. He's just a famous quack exploiting common myths in altie culture and identity politics to sell his quackery as well as demonize his critics so his loyal followers won't listen to the criticism with an open mind. This isn't an extraordinary event, this is business as usual. Heck, it's more about Burzynski using misdirection than secrecy, so I don't really think it's that much of a conspiracy in the traditional sense. He's just using the preexisting anti-science culture to his advantage.
@Lawrence....if you have read my website you would have seen a photo of me on the front cover of Canteen (a kids with cancer group mag). All my mates on chemo & rad for BT that I knew, have all passed away long ago. I would never put up a site like this to highlight the dreadful anguish they went through whilst on chemo & rad treatment. You would have to be a lowlife to prove a point that you think is relevant to the arguments being debated on this site. The guy has no idea of how patients feel and you don’t either. Go to a kids cancer group and hang around awhile and you will discover the anguish they go through. Burzynski does not pretend that his treatment is a sure fire cancer cure, nor do Oncologists think that they have a sure fire cure either. This is the reason why I am campaigning for a second choice in treatment, to level the playing field, to simply give parents a balanced view to make a decision based on scientific evidence of treatment efficacy and outcomes for their children.
A second choice, that is basicly choosing a scam-artist robbing people from their money, isn't a second choice in my opinion.
@TruBlu
Then it would help to have scientific evidence to support the claimed efficacy and outcomes. That's what we're pushing Burzynski for. Why aren't you?
In comment #59, TruBlu tells us that the Australian TGA has given its official imprimatur to Burzynski:
Except it's a kind of double-secret-probation official recognition that doesn't involve any press releases, or information on websites, or any public statements at all:
So what it comes down to is this: the TGA has not refused to read whatever information Stan provides when he applies for approval, and you are proclaiming that as a "Green Light" and an "excellent confirmation of Burzynski’s work"?
Good idea, thanks. Can you provide the e-mail address for the specific Head of Evaluation? The TGA has multiple evaluation teams, and an application could be for real-medicine status or Complementary Medicine status -- not to mention the Office of Scientific Evaluation.
You completely fail to understand what constitutes "scientific evidence."
In your own words, what is the meaning of the phrase 'scientific evidence?'
@TruBlu - I see that you are excellent at not answering the actual question. We have no proof that Dr. B's treatments work, because he refuses to provide the necessary proof (or evidence or anything else for that matter).
Why do think that is? Why should be we take his word for it?
How would you feel if you were told that you just needed to take car or airline safety on someone's word, as opposed to actual evidence?
While Burzynski may not claim he has a sure-fire cure he does claim that his treatment can cure advanced cancers which standard-of-care treatment cannot--agreed? What is the basis of that claim? it certainly isn't the multiple clinical trials he's started and abandoned over teh past couple of decades...
Hopefully I haven't italicized the internets...
Trublu @#71:
So at some point in the future, Burzynski may apply to the Therapeutic Goods Administration in Australia and present them with all the information that he is keeping secret from his experiments. If the information is convincing, the TGA will approve the antineoplastons that he no longer talks about in the US. This hypothetical recommendation means we should trust in Burzynski's honesty now, and stop asking for evidence.
There is too much of the subjunctive mood here; it is a long way from "campaigning [...] to simply give parents a balanced view to make a decision based on scientific evidence of treatment efficacy and outcomes for their children."
@TruBlu - so what is good for the good should be good for the gander, right? I mean, why force major pharmaceutical companies to prove that their treatments are actually safe and work, we'll just take their word for it from now on, right?
@HDB
I think the implication might also include "Burzyinski is brilliant, and it's so obvious that anyone not supporting him must be up to no good".
@TruBlu
I find it funny that you are annoyed that regulars haven't posted evidence, and yet you don't care that Burzyinski hasn't ever supplied his own... It's almost as if you use double standards...
This sentence either makes no sense or you think Australia is not part of the great global conspiracy to suppress truth (TM) and/or not part of you know, peer review. Sorry, have you forgotten you're using the internet and not shipping letters across the sea?
As usual the Burzyinski supporters arguments amount to no more than "why can't you just trust him?"
The outcome of review was… the TGA awarded a ‘Green Light’ for go ahead to present a Full Data Package and NDA towards registration for marketing in Australia.
Would this not been seen as an excellent confirmation of Burzynski’s work.
h, I see from TruBlu's website that this happened "in November 2001". Eleven feckin' years have passed since the Australian TGA told Burzynski "Yeah mate, go ahead with your application, we'll look at your evidence" -- and the ball remains in Burzynski's court.
Acceptance by the TGA would indeed be "the best recommendation you could get", but like every other opportunity for Peer Review, Stan has spent eleven years avoiding it.
But TruBlu argues precisely because Stan ran away from his own application eleven years ago when he realised that it would require real evidence, this makes him more trustworthy. Really, WTF?
@TruBlu
I'm sorry you feel that way. My opinion has been the same all along, whether you recognize that or not: it is possible that antineoplastons work for some cancers in some circumstances, but it is impossible to tell what those cancers and circumstances are because Burzynski does not publish the results of scores of trials paid for by thousands of patients over a period of decades.
The question isn't his personal worth, or yours; it's the worth of his supposed treatment. You would not believe a treatment worked just because the CEO of Merck said it did; why should I believe antineoplastons work just because Burzynski says they do?
What if a representative of Merck turned up on this site and proudly announced that Merck has had "patents that could change the paradigm of the current cancer merry-go-round" and has been refusing to properly test or publish them for decades because to do so would harm their bottom line? Would you sit back comfortably and say that is fine to conceal the cure for decades while cancer patients die by the millions because what really counts is Merck's bottom line? If not, why do you expect me to think that what counts is Burzynski's bottom line?
Do you think that whole institution is going to drop everything and pore over reams of paperwork to evaluate every one of Burzynski's seventy-some Phase II trials? Far better to publish in a peer-reviewed journal and let researchers all over the world consider the results. And how is anyone to evaluate the Phase III trials which have never accrued patients?
Probably not. Do you think that his website administrator just arbitrarily decided one day to scrub the website of all traces of Burzynski's flagship product, his life's work to which he has devoted better than three decades? Do you think the website administrator just arbitrarily decided that would be a good idea, and no one noticed?
Do you think Burzynski would give individual interviews to every person on the planet who wants to know more about antineoplastons? Do you think every person on the planet who wants to know more about antineoplastons should have to be a good interviewer who can successfully question Burzynski?
If I want to know something about a decades-old breast cancer treatment, I don't expect to have to interview Orac about it. I expect to find the information published in peer-reviewed journals. Why would I have to interview Burzynski to find out about his decades-old treatment?
IANAL, but I do know a little about patents. A patent is a legal monopoly, allowing the patent-holder (inventor or buyer) to prevent all others (in the patent's jurisdiction) from making, using, and selling the subject of the patent. This exclusivity lasts, in the US, for 20 years.
If "antineoplasons" were not patented, then anyone who has an interest in cancer could make and test them. With the patent, Burzynski prevents all research, except by those of whom he approves. No one else is allowed to run any tests, much less report on safety and efficacy.
You can be certain, given the patent status, that any report that has been published on ANPs is not the work of an independent researcher: it's someone acting under license from Burzynski.
Since Burzynski has steadfastly refused to perform or allow any meaningful testing (much less report on it), it seems obvious that ANPs are not about to "change the paradigm of the current cancer merry-go-round", and that your hero Burzynski knows it. There's no need to conjecture about conspiracy plots — a conspiracy would require someone besides your hero to illicitly share control of the patents, and there's no indication of this, nor need for it.
@Bill Price: that prompts a thought: one complaint that Big Pharma has made is that the time required to shepherd a drug through testing is so long compared to the length of the patent that they have very little time under patent to make up for the cost of development. Burzynski doesn't seem concerned about that. I wonder why not.
United States Patent4,559,325
Burzynski December 17, 1985
Purified antineoplaston fractions and methods of treating neoplastic disease
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PAL…
This seems to have expired seven years ago. I guess Burzynski missed his chance and Big Pharma jumped in to steal his discovery ... oh, wait.
United States Patent4,470,970
Burzynski September 11, 1984
Purified antineoplaston fractions and methods of treating neoplastic disease
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=2&u…
Expired eight years ago, so anyone could jump in. I wonder why Burzynski wanted the patents at all? Just to ensure no one else tested his claims?
@TruBlu
I received a reply from TGA about some questions. One answer that was clear: "NDA" is not an abbreviation or term used by them. While they said they could not comment on any product not registered (which makes me wonder how you got your email and if it is actually legitimate), the implication was that a "green light" to lodge a data packet simply means that a sponsor can submit his data for review. It does not imply that there is any validity to the investigational drug. That was my reading of the response I received, but I've written back to clarify the point.
So this email you claim to have does not appear to mean what you hold it to mean. I also begin to doubt whether it is actually from TGA or not.
@TruBlu
Got another response from TGA. For reference, the person with whom I corresponded was Klara, in the Application Management & Exports Section of the Office of Medicines Authorisation.
1) NDA is not a term used by TGA.
2) A 'green light' to lodge a full data packet means that TGA has taken a brief look at a proposed submission and allocated resources for a more complete review. It does not mean that TGA endorses or approves the investigational drug, nor does it imply that the drug is safe or effective.
3) TGA is not able to comment on specific drugs that have not yet been registered.
It seems my initial hunches, based on my previous regulatory education, were correct. What was that you were saying about my credibility?
Orac beats a dead horse, & then beats it again:
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"In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy. Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing."
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Gee Orac!!! Why should we take YOUR word for it?? Why not provide support for your comments rather than just rhetoric???
(Whatever happened to OracIsGod?)
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6/3/1992 - Antineoplastons
http://www.ncbi.nlm.nih.gov/m/pubmed/1583762
'Antineoplastons' An Unproved Cancer Therapy
Saul Green
Zol Consultants, Inc, New York, NY.
JAMA: The Journal of the American Medical Association, American Medical Association
JAMA 267 (21): 2924-2928 (1992), PMID .1583762
DOI: 10.1001/jama.1992.03480210086037
Silverchair Information Systems
http://jama.jamanetwork.com/article.aspx?articleid=397590
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Saul Green Resume
https://www.burzynskimovie.com/images/stories/1992_JAMA/Green_Resume.pdf
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6/3/1992 * 1/27/1993 * 1995
https://www.burzynskimovie.com/images/stories/1992_JAMA/1992_JAMA_Green…
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6/8/1992
http://www.burzynskimovie.com/images/stories/1992_JAMA/LetterFromKurume…
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6/9/1992
http://www.burzynskimovie.com/images/stories/1992_JAMA/LttrfromGeorgiaB…
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8/1/1992
http://www.burzynskimovie.com/images/stories/1992_JAMA/LttrfromScharffM…
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1/27/1993 - Antineoplastons
http://www.ncbi.nlm.nih.gov/m/pubmed/8419664
Antineoplastons: the controversy continues.
S Burzynski
JAMA 269 (4): 475; author reply 476 (1993),
Comment on
JAMA. 6/3/1992; 267 (21): 2924-8. PMID .8419664
Silverchair Information Systems
http://jama.jamanetwork.com/article.aspx?articleid=402999
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1/27/1993 - Antineoplastons
http://www.ncbi.nlm.nih.gov/m/pubmed/8419665
Antineoplastons: the controversy continues.
R G Houston
Comment in
JAMA. 1993 Jan 27; 269 (4): 475-6. PMID .8419665
Comment on
JAMA. 1992 Jun.3; 267 (21): 2924-8. PMID .1583762
DOI: 10.1001/jama.1993.03500040041028
Silverchair Information Systems
http://jama.jamanetwork.com/article.aspx?articleid=403002
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1/27/1993 - Antineoplastons: the controversy continues.
http://www.ncbi.nlm.nih.gov/m/pubmed/8481179
Harold J. Wanebo, MD
JAMA. 1993 Jan 27; 269 (4): 476. PMID .8481179
Comment on
JAMA. 1992 Jun.3; 267 (21): 2924-8. PMID .1583762
JAMA. 1993 Jan 27; 269 (4): 475; author reply 476.
JAMA. 1993;269(4):476. doi:10.1001/jama.1993.03500040041029.
Silverchair Information Systems
http://jama.jamanetwork.com/article.aspx?articleid=403004
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2/1999 - A10 & AS2-1 - Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Objective: To assess the pharmacokinetics, toxicity, & efficacy of antineoplastons
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma
J C Buckner, M G Malkin, E Reed, T L Cascino, J M Reid, M M Ames, W P Tong, S Lim, W D Figg
Department of Oncology, Mayo Clinic Rochester, Minnesota USA.
Comment in Jun; 74 (6): 641-2.
Mayo Clin Proc 74 (2): 9 PMID .10069350 ©1999 Elsevier Ltd.
Mayo Clin Proc 1999; 74: 137–145.
Mayo Clin Proc 1999; 74: 137–45.
DOI: 10.4065/74.2.137
Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/full…
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http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PII…
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6/1999 - A10 & AS2-1 - Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1.
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute, Houston, Tex
Mayo Clin Proc 74 (6): 641-2 (1999), PMID .10377942
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2.
Comment on
Mayo Clin Proc. 1999 Feb; 74 (2): 137-45.
Mayo Clinic Proc. 1999; 74: 641–642 (letter)
DOI: 10.4065/74.6.641
Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/full…
.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PII…
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6/1999 - A10 & AS2-1 - Phase II
Mayo Clinic Proceedings
Efficacy of Antineoplastons A10 and AS2-1
Jan C. Buckner, MD, Joel Reid, PhD, Mark Malkin, MD, FRCPC
74(6):2 ©1999 Elsevier Ltd.
DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/full…
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PII…
I wonder if DJT actually reads any of the material he links to. For example one of the articles he links to explains elegantly:
In other words, the evidence that Burzynski has presented to support the efficacy of antineoplastons, and which DJT repeatedly regurgitates messily at every opportunity, is not convincing.
Methinks My "Learned" colleague KreBloggerZen protesteth too muchly. (Post #102)
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Unlike OracIsGod, I supplieth the documentation.
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Whilst my "Learned" friend missith the point entirely about said Mayo Whine & Cheese:
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"CONCLUSION: Although we could not confirm any tumor regression in patients in this study, THE SMALL SAMPLE SIZE PRECLUDES DEFINITIVE CONCLUSIONS ABOUT TREATMENT EFFICACY."
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(Words CAPITALIZED for your reading enjoyment. ENJOY THAT Mayo Whine & Cheese!!!)
Given that two of those links are to an article about tick bites in a nudist camp, I'm thinking not.
http://en.m.wikipedia.org/wiki/Flogging_a_dead_horse
Hoping one day the some people (#104) will realize that web-sites sometimes have "moving" links, which is why I try to provide multiple links/citations.
One wonders if DJT would like this video:
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
"Moving links"? This is even more stupid than "the dog ate my homework." You simply never bothered to even look to see what was at the other end of the link that you were barfing up.
It's obvious which one of us who has actually "fact-checked" items on here. I didn't see you providing links to both pro/con sides or pointing out the conclusion of the Mayo study.
.
So go back to your igloo & eat your "blubber."
This one is seriously off the meds.
"Igloo"?
"Conclusion: Although we could not confirm any tumor regression in patients in this study, the small cample size precludes definitiive conclusion about treatment efficacy."
Words bolded to indicate exactly where you've completely failed to comprehend the import of the study's finding.
I see Squidymus is continuing to defend someone whom he claimed he wasn't defending...
@flip
Also noticed that TruBlu has fallen suspiciously quiet after being such an outspoken supporter of Burzynski.
Perhaps his housing facility restricts his internet hours.
The reception here for TruBlu was rather unfriendly -- unavoidably so when she was advancing silly claims and arguments -- so her subsequent absence is understandable.
From her website she is evidently a long-term survivor of a nasty brain tumour,, so that's something worth celebrating, even though I suspect that she over-estimates how much Burzynski's treatment contributed to her cure.
I'd like to think that we gave her a lot to think about and, after her initial angry reaction, she went away to seriously think about what she read here.
@Todd W
As I'm behind in my reading of both posts and comments, I can never tell when someone disappears or not. That people flounce off when the discourse appears harsh - as it did to me when I first started reading science websites - is not a surprise.
#112 JGC (Just Gullible Cad)
Being the intellectually honest individual you are, I take it that you read the published response by SRB & the reply; since I did provide the links. Correct?
#113 flip
FlipFlop, I take it you actually read all the linked articles & because of your unbiased values that you noted that I didn't indicate that you should take my word for it?
Cookie please.
Am I correct in understanding "the published response by SRB & the reply" to refer to the marked up copy of Saul Green's article in Jama? If so yes. If you're referring instead to some other of the mulitple citations you've been spamming the thread with please identify it more specifically.
Assuming that is the document you're asking about, as neither the response nor Green's reply to that response represents evidence that antineoplastons are effective at treating advanced cancers I have to ask--did you have a point in calling our attention to it?
#119 Didymus Judas Thomas
At the Tu-Quack Center Biased Blogger boardroom
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#112 JGC (Just Gullible Cad)
Being the intellectually honest individual you are, I take it that you read the published response by SRB & the reply; since I did provide the links. Correct?
.
#122 JGC
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"Am I correct in understanding “the published response by SRB & the reply” to refer to the marked up copy of Saul Green’s article in Jama? If so yes. If you’re referring instead to some other of the mulitple citations you’ve been spamming the thread with please identify it more specifically.
Assuming that is the document you’re asking about, as neither the response nor Green’s reply to that response represents evidence that antineoplastons are effective at treating advanced cancers I have to ask–did you have a point in calling our attention to it?"
.
So, above, I specifically indicate your post #112 re the 1999 Mayo phase II study & you proceed in your above post #122 to go on about the non-Mayo stuff. Okay ... ;)
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#112 JGC
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“Conclusion: Although we could not confirm any tumor regression in patients in this study, the small cample size precludes definitiive conclusion about treatment efficacy.”
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#112
"Words bolded to indicate exactly where you’ve completely failed to comprehend the import of the study’s finding."
DJT, that was a truly illuminating post. Now I just have to work out what you are trying to blather about. It seems to me you are getting youself all blathered up about this sentence in a paper:
"Conclusion: Although we could not confirm any tumor regression in patients in this study, the small cample size precludes definitiive conclusion about treatment efficacy.”
Let me give you (another) hint about its meaning. It means the authors found no effect. That is all it means, nothing more.
Let's give the last word to the authors from the conclusion to the manuscript:
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma
#124 ChrisPy, BRAVO!!!
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Now see post # 23:
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
#85 Didymus Judas Thomas
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January 27, 2013
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As I’ve posted before, some people get on here & post away without any fact-checking.
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One was some post along the lines that Davorit Samid had no professional relationship with SRB.
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Now that I have some time … Oh, really???
http://www.burzynskimovie.com/images/stories/transcript/Documents/Resea…
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Orac: ""Be that as it may, the researcher to which Merola refers is Dvorit Samid, who is currently Vice President of Medical Affairs at Synta Pharmaceutical and was Section Chief Differentiation Control, National Cancer Institute/National Institutes of Health Division of Cancer Treatment from 1990 to 1995."
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"Be that as it may, the claim that Dvorit Samid “stole” Burzynski’s antineoplaston patents strikes me as rather questionable (at best), given that, first, Samid was not “one of Burynski’s scientists” but a section chief at the NCI."
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UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES
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April 16, 1990
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Dear Dr. Burzynski:
.
I would like to take this opportunity to express my thanks to you and your wife for the exceptionally warm attitude during our trip in Europe. I hope that this is just the beginning of a long and exciting relationship.
.
Upon your request, I have summarize some of my research plans for Antineoplaston AS2-1. (An official research proposal will follow; this has to go through the appropriate University channels and would take much longer to prepare). The proposed work is based on our preliminary experience with AS2-1. We could include A10 in the in-vivo studies. Also, I would like to initiate the isolation and characterization of active peptides from A2: It is my impression that A2 contains most active anticancer substance(s) (more active, per molar ratio, compared to AS2-1) which could induce differentiation through non-toxic novel mechanisms. Our tumor differentiation and phenotypic reversion models would be most useful in detecting such activities.
.
As you know, however, the Antineoplaston research in my laboratory depends totally on extramural funding. Unfortunately, I can not see the NCI fund this work in the near future. Sigma-Tau, on the other hand, provided us with a budget that will run out in a month or two. I hope that this will not mean a delay/termination of our important research, and wish you Good Luck in meetings with the potential supporting agencies !
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With warm regards to you and Barbara,
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Yours,
.
Dvorit Samid, PhD
Assistant Professor of Pathology
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p.s. please send more AS2-1 powder, > 30 ).
enc.
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Research Proposal
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ANTINEOPLASTON AS2-1 IN CANCER PREVENTION AND THERAPY
.
Dvorit Samid, PhD
Department of Pathology, Uniformed Services University
of the Health Sciences, Baltimore, Maryland
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Antineoplastons may offer a novel alternative to current non-satisfactory cancer therapies.
.
The limited preclinical and clinical experience with the Antineoplaston AS2-1 (sodium salts of phenylacetylglutamine and phenylacetic acid 1:4) has been most promising, showing potent antitumor activities with minimal or no adverse effects. However, the efficacy and mechanisms of action of AS2-1 are not well characterized. We proposed to develop a comprehensive preclinical program aimed to evaluate the potential role of AS2-1 (used alone and in combination with other drugs) in cancer prevention and therapy. The following projects are proposed:
.
I. AS2-1 in Cancer Therapy.
.
A variety of in-vitro and in-vivo tumor models, involving genetically characterized human and mouse tumor cell lines, will be used to test for tumor-directed effects of AS2-1. The biological end-points to be examined are: (a) inhibition of cell proliferation; (b) induced phenotypic
reversion; and, (c) terminal cell differentiation. A special emphasis will be placed on the latter since differentiation therapy is a most desired approach to fighting cancer. Our preliminary data indicates that AS2-1 may indeed be a potent differentiating agent. To determine the efficacy of the Antineoplastons under physiological conditions, in-vitro studies will be extended to include athymic mice carrying primary and metastatic human tumor cells. The phenotypic observations will be coupled with molecular analyses focusing on alterations in gene expression (oncogenes and others), in order to determine the mechanisms of AS2-1 anti-tumor action.
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II. The Efficacy of Combination Therapies.
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It is well recognized that tumors are composed of heterogeneous cell populations that vary in their drug responses. Therefore, appropriate combination treatment protocols, including agents that suppress tumor growth through different mechanisms, are likely to be more effective compared to monotherapies. We plan to examine the efficacy of AS2-1 in combination with other biological (i.e., interferon) and with chemotherapeutic drugs, in order to realize their full anticancer potential.
.
(a) AS2-1 and Interferon. The pleiotropic biological response modifiers interferons (IFNs) have gained much attention in recent years due to their anti proliferative and antitumor activities. However, the clinical experience with IFN
has been rather disappointing. We shall test the efficacy of IFNs (Roferon) in combination with AS2-1. Our preliminary data showed that such a combination has synergistic effect inhibiting cancerous growth, and thus potentially a potent therapeutic approach.
.
(b) AS2-1 and Classical Chemotherapy. While numerous chemotherapeutic drugs can effectively suppress cancer growth, they pose a clinical problem due to the toxic, mutagenic and carcinogenic side effects. The greatest concern is the fact that the drugs may actually promote recurrences. Interesting, our preliminary data suggests that AS2-1 can prevent tumor progression induced by some chemotherapeutic drugs. Moreover, combination treatments with AS2-1 might allow to lower doses of chemotherapeutic drugs , thus further minimizing their adverse effects. The specific drugs to be evaluated will be determined depending on the tumor types of interest (see section IV, b and c).
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III. Antineoplastons in Tumor Prevention and Maintenance Therapy.
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Current advances in molecular techniques allow the detection of genetic disorders associated with predisposition to cancer. Consequently, it is now possible to identify high-risk individuals and patients (in remission) with residual disease. Inspite of these remarkable capabilities, there is no acceptable preventative treatment. Antineoplastons may play a role in cancer prevention; indeed, there is some experimental evidence supporting this hypothesis. The use of AS2-1 in prevention and long-term maintenance therapy (to minimize disease relapse) is well tolerated by patients. The efficacy of AS2-1 will be examined using oncogene-primed premalignant cell and animal models, all of which are predisposed to cancer development.
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IV. Preclinical Studies of Patient Tumor Responses.
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Preclinical studies rely primarily on the use tumor cell lines, which arise from selected sub populations of tumor cells. To obtained more clinically relevant data, it is important to evaluate the efficacy of new drugs also on authentic patient material. We plan to develop a novel in-vitro three-dimensional (3D) model, involving tumor biopsies grown on agar plugs, which precludes the selective outgrowth of tumor subpopulations. Under the 3D conditions, and in contrast to the 2D growth on plastic or glass surfaces, tumor responses to anticancer agents may mimic closely that occurring under physiological conditions. The 3D model will be used to:
(a) obtain data on tumor growth, necrosis and cellular differentiation in treated tissues.
(b) identify those tumor types more likely to respond to treatment with AS2-1.
(c) determine the efficacy of different combination therapy protocols.
(d) study tumor responses in parallel to the clinic, in order to determine the predictive value of the 3D model. --If so, this system could be used in the future to prescreen patients candidates for Antineoplaston therapy.
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Summary. Current approaches to combat cancer rely primarily on the use of chemicals and radiation, which are themselves carcinogenic and may promote recurrences. There is, therefore, an urgent need for new effective and safe treatment modalities. The Antineoplaston AS2-1 may offer an attractive approach to cancer prevention and therapy. Our proposed studies have been designed to help realize the full therapeutic potential of AS2-1 before its wide use in the clinic.
SUMMARY of PRELIMINARY RESULTS / Dr. SAMID
(November 1989 - April 1990)
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I. Phenotypic Reversion by AS2-1 of Mouse Fibrosarcoma V7Z Cells
.
1. Profound and rapid restoration of contact inhibition of growth, and loss of anchorage independence
2. Long-term treatment may result in stable phenotypic reversion (?)
3. Effective in cells resistant to other cytokines (IFN)
4. Modulation of gene expression:
a. inhibition of ras oncogene expression
b. induction of collagen biosynthesis ( differentiation ?)
c. induction of 2'-5'A synthetase (autocrine IFN ?)
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II. AS2-1 : Prevention of Neoplasticism Transformation and Tumor Progression
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1. NIH 3T3 cells Prevention of spontaneous or oncogene-induced transformation (gene transfer studies)
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2. Oncogene-primed 3T3 cells Prevention of tumor progression by the chemotherapeutic drug 5AzadC
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III. AS2-1 Induced Cell Differentiation
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1. HL-60 promoeyelocytic leukemia
reduced proliferation
monocyte/granulocyte (?) conversion (NBT-positive)
inhibition of myc oncogene expression
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2. K562 erythroleukemia
reduced proliferation
increased hemoglobin production
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3. NIH 3T3 and C3H 10T1/2 embryonic fibroblasts
reduced proliferation
adipocyte conversion
no induction of neoplastic transformation
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BUDGET
.
I. An Estimated 12 Month Budget Required for Developing a
Comprehensive Research Program on Antineoplastons, with a
prime focus on AS2-1 and A2.
.
Personnel (salary plus benefits):
2 research assistants. $70,000
1. technician. $25,000
1. student stipend. $10,500
Supplies (reagents, animals, small equipment). $28,000
Administrative support. $4,000
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(Plus 42% university overhead) $137,500
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Research support is requested for five years.
__________________________
II. Immediate Minimal Budget Requirement
.
This is needed in order to continue the ongoing research, so that we
can bring the preliminary data to a "Publishable" stage. We will also
initiate studies on the combination AS2-1 and Interferon alfa
(Roferon) , so that I could submit a more comprehensive proposal to
Roche within one year
.
Personnel (salary plus benefits):
50% support of a research assistant. $17,000
50% support of a technician. $12,000
50% of a students stipend. $5,000
Supplies. $10,000
Administrative support. $2,000
.
(plus 42% university overhead). $46,000
Orac
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"This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with."
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Since 2009, permission for the final phase of FDA clinical testing to allow Antineoplastons to be "FDA-approved" has been granted.
.
The only obstacles now are the $300 million $s needed to pay for this final phase of clinical testing-& the FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in these Phase 3 trials, claiming it would be "unethical" not to do so.
.
In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close.
.
Phase III trials are the 3rd & final phase before reaching FDA approval.
.
These trials could being worldwide in 2010, barring the ability to raise the money to fund them.
.
The FDA has officially mandated that some patients participating in these Phase III trials also be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment—claiming it would be “unethical” not to do so.
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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
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EX-99.1 4 a09-2965_1ex99d1.htm EX-99.1
Exhibit 99.1
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HOUSTON, TX - 1/13/2009 – The Burzynski Research Institute, Inc. (BRI) today announced that it has reached an agreement with the U.S. Food and Drug Administration (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.
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Antineoplaston therapy (ANP) uses a synthetic version of naturally occurring peptides & amino acid derivatives found in the human body to target & control cancer cells without destroying normal cells.
.
The agreement was made under the FDA’s Special Protocol Assessment (SPA) procedure & means that the design & planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval.
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“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant & challenged further by severely limited treatment options & clinical trials that could expand & discover new, efficacious therapies,” said Stanislaw R. Burzynski, M.D., Ph.D.
.
“The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.”
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“BRI has reached this important milestone independently without financial backing from the government, & without a major pharmaceutical partner—a unique accomplishment in the oncology field.
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From inception, we have been committed to developing a targeted gene therapy option that is less aggressive on the body than conventional therapies & have made considerable progress on the steps mandated by the FDA to bring a new drug to a patient community & cancer type that has unmet needs.”
.
About the Phase III study
The primary objective of this randomized study is to compare overall survival of children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) & AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone.
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DBSG are considered to be 1 of the most difficult types of cancer to treat. It combines highly malignant characteristics with the very difficult location of the brainstem.
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DBSG are inoperable because they involve most of the brainstem (diffuse & intrinsic).
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The # of children in the U.S. with brainstem gliomas is approximately 660.
.
Absent treatment, the survival rate from time of diagnosis is 6 months or less.
.
At present, there are no standard curative treatments for the disease.
.
RT is the only treatment that may slow its progress, but at 2 years 93% of children with this type of cancer die, & none of them survive for 5 years.
.
Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective.
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There are no pharmacological treatments approved for DBSG at this time.
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Burzynski Research Institute, Inc. (OTCBB: BZYR) is a biopharmaceutical company committed to developing treatment for cancer based on genomic & epigenomic principles.
.
Research & development efforts are focused on basic ANP research & 19 Phase II clinical trials.
.
Burzynski Research Institute, Inc.
Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws.
.
Burzynski Research Institute, Inc. cautions investors not to place undue reliance on the forward-looking statements contained in this press release.
.
Information contained in forward-looking statements is based on current expectations & is subject to change, & future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks & uncertainties related to BRI’s ability to obtain regulatory approval for Antineoplastons A10 & AS2-1, risks associated with BRI’s ability to raise sufficient capital from the development of its technology towards commercialization, & other risks described in BRI’s periodic reports filed with the Securities & Exchange Commission.
.
BRI does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein.
http://www.sec.gov/Archives/edgar/data/724445/000110465909002283/a09-29…
.
Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval & supervision of the FDA.
.
The patients were treated within "Phase 2 FDA clinical trials", without the aid of the National Cancer Institute, or any other cancer research entity."
.
Antineoplastons are responsible for the 1st recorded cures in medical history within any FDA-approved clinical trial for inoperable brainstem gliomas in children-with a 30%-50% cure rate.
.
A "cure" is defined as 5-year survival.
.
BZYR > SEC Filings for BZYR > Form 10-Q on 10/15/2012
Form 10-Q for BURZYNSKI RESEARCH INSTITUTE INC
.
10/15/2012
.
Quarterly Report
.
Item 2. Management's Discussion & Analysis of Financial Condition & Results of Operations
.
The following is a discussion of the financial condition of the Company as of 8/31/2012, & the results of operations comparing the 3 & 6 month periods ended 8/31/2012 & 2011
.
It should be read in conjunction with the financial statements & the notes thereto included elsewhere in this report & in conjunction with the Annual Report on Form 10-K for the year ended 2/29/2012
.
Introduction
.
The Company 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 acid 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
.
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 S.R. Burzynski, M.D., Ph.D. ("Dr. Burzynski"), the Company's President & Chairman of the Board of Directors
.
Dr. Burzynski funds the Company's operations from his medical practice pursuant to certain agreements between Dr. Burzynski & the Company
.
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 drugs currently being tested for the use in the treatment of cancer, & provides consulting services
.
The Company is currently conducting 1 FDA-approved clinical trial
.
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 & diagnosis of cancer, once an Antineoplaston drug is approved for sale by the FDA
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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 of 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
.
1/13/2009, the Company announced that the Company had reached an agreement with the FDA for the Company to move forward with a pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
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The agreement was made under the FDA's Special Protocol Assessment procedure, meaning that the design & planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval
.
2/23/2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint ("ResearchPoint") 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
.
ResearchPoint is currently conducting a feasibility assessment
.
ResearchPoint has secured interest & commitments from a number 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 DBSG who receive combination Antineoplastons A10 & AS2-1 plus RT versus RT alone
.
Results of Operations
.
3 Months Ended 8/31/2012 Compared to 3 Months Ended 8/31/2011
.
Research & development costs were approximately $1,497,000 & $1,741,000 for the 3 months ended 8/31/2012 & 2011, respectively
.
The decrease of $244,000 or 14% was due to decreases in material costs of $390,000, & other research & development costs of $6,000, offset by an increase in personnel costs of $160,000, consulting & quality control costs of $26,000, & facility and equipment costs of $34,000
.
General & administrative expenses were approximately $297,000 & $44,000 for the 3 months ended 8/31/2012 & 2011, respectively
.
The increase of $253,000 or 575% was due to increases in legal & professional fees of $92,000, $160,000 related to warrants issued to non-employees for marketing & consulting services, & other general and administrative expenses of $1,000
.
The Company had net losses of approximately $1,794,000 & $1,785,000 for the 3 months ended 8/31/2012 & 2011, respectively
.
The increase in the net loss from 2011 to 2012 is primarily due to the overall increase in general & administrative expenses, offset by a decrease in research & development expenses of the Company described above
.
6 Months Ended 8/31/2012 Compared to 6 Months Ended 8/31/2011
.
Research & development costs were approximately $3,035,000 & $3,175,000 for the 6 months ended 8/31/2012 & 2011, respectively
.
The decrease of $140,000 or 4% was due to decreases in material costs of $473,000 & facility & equipment costs of $36,000, offset by an increase in personnel costs of $304,000 & consulting & quality control costs of $65,000
.
General & administrative expenses were approximately $439,000 & $110,000 for the 6 months ended 8/31/2012 & 2011, respectively
.
The increase of $329,000 or 299% was due to increases in legal & professional fees of $169,000 & $160,000 related to warrants issued to non-employees for marketing & consulting services
.
The Company had net losses of approximately $3,474,000 & $3,286,000 for the 6 months ended 8/31/2012 & 2011, respectively
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The increase in the net loss from 2011 to 2012 is primarily due to the overall increase in general & administrative expenses, offset by a decrease in research & development expenses of the Company described above
.
Liquidity & Capital Resources
.
The Company's operations have been funded entirely by contributions from Dr. Burzynski & from 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
.
The amounts which Dr. Burzynski is obligated to pay under the agreement shall be reduced dollar for dollar by the following:
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(1) any income which the Company receives for services provided to other companies for research &/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income, or
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(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 Research Funding Agreement, as amended, contains an annual automatic renewal provision providing for an additional 1-year term, unless 1 party notifies the other party at least 30 days prior to the expiration of the then current 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 2/28/2013
.
It is expected that the Research Funding Agreement will continue to renew each year prospectively unless terminated under the provisions of 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 &/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 $3,000,000 during the remaining 2 quarters of 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
.
The Company believes Dr. Burzynski will be financially able to fund the Company's operations for at least the next year
.
In addition, Dr. Burzynski's medical practice has successfully funded the Company's research activities over the last 25 years &, in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy & hormonal 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
.
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
.
Forward-Looking Statements
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Certain matters discussed in this quarterly report, except for historical information contained herein, may constitute "forward-looking statements" that are subject to certain risks & uncertainties that could cause actual results to differ materially from those described in the forward-looking statements
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Forward-looking statements provide current expectations of future events based on certain assumptions
.
These statements encompass information that does not directly relate to any historical or current fact & often may be identified with words such as "anticipates," "believes," "expects," "estimates," "intends," "plans," "projects" & other similar expressions
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Management's expectations & assumptions regarding Company operations & other future results are subject to risks, uncertainties & other factors that could cause actual results to differ materially from the anticipated results or other expectations expressed in the forward-looking statements
http://biz.yahoo.com/e/121015/bzyr10-q.html
Orac
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"This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with it."
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Burzynski Research Institute Partners with Premier Research to Manage Phase III Clinical Study of Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
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1/26/2009 10:05:32 AM
HOUSTON--(BUSINESS WIRE)--The Burzynski Research Institute, Inc. (BRI) today announced that it has partnered with Premier Research, a global clinical research services provider, to initiate & manage a pivotal Phase III clinical trial of combination antineoplaston therapy (ANP) plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
http://www.biospace.com/collaborative/News/burzynski-research-institute…
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Burzynski Research Institute Signs Research Agreement with the University of Alabama at Birmingham, Division of Preventive Medicine, Biostatistics & Bioinformatics Shared Facility
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9/29/2009 10:07:34 AM
HOUSTON--(BUSINESS WIRE)--The Burzynski Research Institute, Inc. (BRI) today announced that it has signed a Research Agreement with the UAB Division of Preventive Medicine, Biostatistics & Bioinformatics Shared Facility (BBSF) that will provide biostatistical & data management support for BRI’s ongoing Phase II & Phase III protocol studies of Antineoplaston (ANP) treatment for gliomas
http://www.biospace.com/collaborative/News/burzynski-research-institute…
Tell everybody about the nudist camp again.
Didymus Judas Thomas - I notice that the two press releases you mention date back more than 3 years. Are the phase III trials recruiting patients? If so, how many are currently participating?
@Narad and M O'B: I take my hat off to you, Sirs. I don't bother to even read what he posts any more. Walls o'text don't do it for me. I just skim over his stream of conscious posting and read what more intelligent, thoughtful people post.
(And I really miss killfile, which for some reason no longer works on sciblogs...)
M O'B: He CAN"T start the trial yet. Don't you know he can't find enough children whose parents have let them have radiation? And he doesn't have enough money?*
*Not my theories, of course. That's what DJT is arguing.
https://pipl.com/directory/name/Samid/Dvorit
At the 9th International Symposium on Future Trends in Chemotherapy, held in Geneva, Switzerland, in March 1990, 7 papers on antineoplastons were presented, including preclinical & clinical results by researchers from Japan, Poland, China, & the US
.
Dr. Dvorit Samid reported,
"Antineoplaston AS2-1 profoundly inhibits oncogene expression & the proliferation of malignant cells without exhibiting any toxicity toward normal cells"
Dr. Samid also explained that her research with AS2-1 shows that it does not kill cancer cells, but rather it reprograms them to behave like normal cells (1)
Dr. Samid concluded that "antineoplaston therapy restores
to the body those natural compounds that have anticancer activity
Because they are natural compounds, the body tolerates them well, & therefore we minimize the problem of adverse effects
Antineoplastons could be a very valuable, effective & safe approach to cancer therapy"
http://curezone.com/diseases/cancer/antineoplastons.asp
That's odd. Let's recall that WMC/Carigen agreement hands out call warrants in lieu of a portion of compensation. Indeed, warrants are normally sold. One thus might wonder whether this expense is related to the exercise of previously issued warrants and to whom they were issued, which circles right back around to the attempts to pump this stuff on penny-stock Web sites.
Orac, isn't technology great???
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Instead of me inputting it, people can just view what I found, using an Internet search!!!
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Screen # / Description
75. 1987 NCI / Chugai
www.naderlibrary.com/burzynski.75.htm
76. 1989 -1990 Sigma-Tau
77. 1990 Élan Pharmaceuticals
78. 1990 & 9/1990 Dvorit Samid
79. 10/1991 Dr. Nicholas Patronas led the National Cancer Institute on their site visit
80. Dr. Michael Friedman, the Associate Director of the Cancer Therapy Evaluation Program
81. NCI
82. Élan Pharmaceuticals / Dvorit Samid / NCI
83. 1994 I started working for Dvorit Samid - LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997 / Phenylacetate
84. Dvorit Samid
85. John Hopkins / Dvorit Samid / Élan Pharmaceuticals
86. 4/1992 phenylacetate / Dvorit Samid
87. 1995 Dvorit Samid / BRI
88. BRI
89. NCI / Dvorit Samid / Élan Pharmaceuticals
90. NCI / Dr. Michael Friedman
91. Friedman / SRB
92. NCI / Friedman
93. NCI / Friedman / SRB
94. Memorial Sloan-Kettering Cancer Center
95. NCI / SRB
96. 4/1995 SRB
97. 4 - 5/1995 Mayo Clinic in Minnesota / Sloan-Kettering Hospital in New York
98. 4 - 5/1995 NCI
99. 5/1995 The Clinical Trials Monitoring Service (CTMS)
100. 6/1995 Friedman
101. 6/1995 Friedman / SRB
102. 6/1995 NCI
103. 10/1995 & 2/1996 NCI's Cancer Information Service
104. 2/1999
105. LI-CHUAN CHEN, PH.D., NCI SCIENTIST 1991.-.1997
106. 10/4/1991 NCI site visit
107. 10/21/1991 & 4/1993 The Department of Health and Human Services, & Dr. Dvorit Samid / NCI
108. 2./29 & 10/12/1993
109. 10/12/1993, 3/7 & 10/12/1994 & 6/6/1995
110. 6/6 - 7/1995
111. 2 & 6/1997 - 2000
112. 1997 - 2000
113. NCI / Élan Pharmaceuticals
114. Patents
115. phenylacetate & phenylacetylglutamine
116. American Medical Association / American Cancer Society
117. JAMES RAPPAPORT, DANA-FARBER CANCER INSTITUTE, MEMBER, BOARD OF DIRECTORS
118. Rappaport
119. Rappaport
120. Credits
Samid
http://patents.justia.com/inventor/dvorit-samid
.
https://pipl.com/directory/name/Samid/Dvorit
#131. Mephistopheles O'Brien
.
Mobster, are you now taking over Orac's duties?
.
Are you his proxy?
.
Because if you are, I'm patiently waiting for your response to:
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#73
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
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Because I haven't seen Orac (or OracIsGod) respond to it yet.
.
Mobby, I noticed that Orac reposts a lot of his incorrect blogsplats & doesn't seem to make much of an effort to stay up-to-date on what's made available on the web-sphere re his fave subject.
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For example, searches on:
.
Cycle Solutions, ResearchPoint, Premier Research, University of Alabama at Birmingham, UAB, Division of Preventive Medicine, Biostatistics and Bioinformatics Shared Facility, BBSF, feasibility assessment, & Research Agreement
.
results with no results on Orac's blogsplat.
.
This concerns me greatly because it gives the impression that Orac doesn't know his subject-matter, & why should anyone take Orac seriously if he's not knowledgeable about what's going on?
.
1. What happened re the "feasibility agreement?"
.
2. What happened re the funding?
"The only obstacles now are the $300 million $s needed to pay for this final phase of clinical testing-& the FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in these Phase 3 trials, claiming it would be “unethical” not to do so."
"These trials could being worldwide in 2010, barring the ability to raise the money to fund them."
.
3. Why the "FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in these Phase 3 trials, claiming it would be “unethical” not to do so?"
(I am informed that warrant issuance is normally booked as an expense if it is above the current fair market value of the shares. Considering the dime value of the foreign warrants and the price history, I'm going with grant, pump, exercise, and dump, with the net loss being reported.)
"At the 9th International Symposium on Future Trends in Chemotherapy, held in Geneva, Switzerland, in March 1990"
And it seems that as with many Big Pharma drugs that showed promise in vitro and even in small clinical trials, this treatment just didn't hold up and twenty-three years later, it has sunk into the swamp and been all but forgotten.
This has become a serious game of whackamole. Now it is dozens of quotes from the movie, circular references to its own posts elswhere on the blog and large cut and paste from its arguments on wikipedia.
I guess this as close as an admission of defeat there is likely to be from DJT
Oh, great, now it's dredging other people's stupidity for material and getting it wrong at that.
You really did not want to send me to this 10-K, Piddles. Shall we examine the Research Funding Agreement?
What happens next is that we take a look at the footnotes to those financials to try to figure out what's going on with that 160 grand.
BTW, the Burzynski Research Institute seems to offer employees a really crappy insurance and 401(k) combo.
#141. Narad
.
Because I haven’t seen Orac (or OracIsGod) respond to it yet.
.
"Oh, great, now it’s dredging other people’s stupidity for material and getting it wrong at that.."
.
Hey, NaraDclue!! In case you forgot, Orac is the one who brought up the 1999 Mayo phase II study; which SRB objected to in his reply in the Mayo Clinical Proceedings publication, & which is also covered in the above post #136, so it is "fair game" since Orac was citing it as support for HIS position.
#142. Narad
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"You really did not want to send me to this 10-K, Piddles."
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NaraDNA, TrustMovies Me. When I got up at the crack of MI Dawn, I wasn't "skeered" of anything you might do considering your consistent track record of inability to provide citations &/or references in a competent consistent manner.
.
Have you thought of contacting Craig Masilow & finding out if he can post some inane comments re Part II of the SRB documentary so that WP can quote him again??
.
Maybe you can send him a hatchet???
There needs to be a character limit for comments. Or a Squidymus limit... either one.
Oh and for laughs, Squidymus pumped out naderlibrary.com, home of the well-known nutcase Charles Carreon. Followers of Popehat will get what I'm talking about, everyone else needs to google the recent case of the Oatmeal and the loons that are the Carreon family. Popehat commenters fairly well dissect the issues with Nader Library, American Buddha and other sites run by the Carreons.
Naderlibrary is hardly a good place for info, given the Mrs is a conspiracy nut, and both like to infringe on copyright, as well as many other things, like fraudulently taking money from clients (Charles is a lawyer). It wouldn't surprise me if both are into woo given their hippy-dippy background. For truly hysterical times, one should visit their many websites, including Rapeutation, dedicated to presenting criticism of Carreon's lawyerly antics as equal to rape. Accuracy is not only not a prerequisite in their eyes, but a thing to be avoided it seems. American Buddha is especially full of conspiracy quackery about Illuminati and such.
In fact, Nader Library is the repository for many stolen works of literature, and the Carreons are being sued by numerous companies for it.
In typical fashion, Squidymus thinks pulling google hits is some form of reliable evidence that we're all meanies and Burzyinski is a god.
I wouldn't normally bother with Squidy, but the Nader Library link is worth pointing out as yet another example of someone being unable or unwilling to read their references before posting them.
@flip: "Naderlibrary is hardly a good place for info"
It's just the sort of place for DJT though. DJT, you should go spend a lot of time there.
@Marc Stephens Is Insane
The "not enough money" argument is pretty funny. I'll put aside the tens of millions -- or more -- that Burzynski has acquired from desperate dying people. Consider that he wants a company to invest in his trial. They look at his history and find that he has started over seventy trials and never properly completed and reported on a single one. Even if antineoplastons showed real promise in trials run by other groups, why would any company want to pour more money into Burzynski's trials when, based on his history, such trials will not produce any results?
The response will be that Burzynski holds the patents and won't let anyone else do the research, to which I reply, (1) then Burzynski is a monster; (2) US patents do not control research worldwide; (3) at least some of the patents are expired anyway; and (4) DJT has regaled us interminably with claims that research is being done in a number of other countries.
Oh, yawn. DJT thinks he's being funny about my name.
Guess, what, Diddums. Dawn IS my name, and MI is where I am from. I use it here because there was another Dawn posting back in the day, and I wanted Orac to know which one I was, as he and I are both MIchiganders.
Now, when you have current information that SB is recruiting for his Phase III trial (instead of the information about all his trials vanishing down the memory hole - or so he hopes), I might read what you post. Till then, I'll keep scrolling over your nonsensical spewing.
@LW
Indeed, Squidymus' word salad style would be at home at the Carreon forums - from what I can tell he and Mrs Carreon share similarities in terms of language usage.
Didn't understand yet another comment, eh? Do you know who "OracIsGod" was?
@flip: " from what I can tell he and Mrs Carreon share similarities in terms of language usage."
Uh... you don't suppose ...
I mean, we started calling DJT "he" but I don't think there was ever any real proof one way or the other...
No, wait, the Carreons are in Arizona. So I guess not.
@LW
I'll admit to not reading much of the Carreons' own work, so it never crossed my mind until I posted that they might be one and the same....
"Transcribed from the movie by Tara Carreon, ABOL Librarian"
Don't miss her cartoon at the bottom of the page.
@Narad #154--
Oh, my.
#130. Narad
.
"Tell everybody about the nudist camp again."
.
NaradNudism, ask Dvorit Samid's NUDE MICE!! ;)
.
11/15/1995 - Sodium PHENYLACETATE Induces Growth Inhibition and Bcl-2 Down-Regulation and Apoptosis in MCF7ras Cells in Vitro and in
NUDE MICE
http://cancerres.aacrjournals.org/content/55/22/5156.abstract?sid=29b3d…
.
http://cancerres.aacrjournals.org/content/55/22/5156.full.pdf
References
1. SAMID, D., Shac, S., and Sherman, L. T. Phenylacetate: a novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988-1992, 1992
#146. flip-o-post-a-lot
.
"Accuracy is not only not a prerequisite in their eyes, ..."
.
This blogsplat isn't actually known for accuracy either, as I've pointed out numerous times.
.
So what's your point? Of did you actually have one??
.
The screenshots are the same as are in the documentary.
Orac: "What exactly happened between Burzynski and the NCI is difficult to discover, as it is documented objectively in few places but trumpeted around the web by Burzynski-friendly sources."
.
"It’s a total of 62 trials over the last 20 years or so, and not a single one of them, as far as I and others who have looked at them have ever been able to tell, has produced any useful evidence for the efficacy of antineoplaston therapy. Is it any wonder that many of us suspect that these “clinical trials” are shams designed to get around the orders of the Texas Medical Board back in the 1990s ."
.
.11/15/1982.- 2 Toronto physicians, Martin E. Blackstein, Head of the Division of Oncology at Mount Sinai Hospital & Daniel E. Bergsagel, Chief of Medicine at Princess Margaret Hospital, visited the Burzynski clinic & research institute
.
Both were powerful & respected physicians in the Canadian cancer establishment
.
They returned with a blistering, critical report
.
The essence of their critique was
.
(1) there was little evidence that antineoplastons had significant antitumor activity against human or animal cancers;
.
(2) SRB's argument that antineoplastons were species-specific created a line of argument for avoiding standard animal & tissue culture screens & required testing in humans
.
SRB cooperated but was dubious
.
There were several test-tube & preventative models in which the drug had showed effectiveness, but the standard NCI pre-screen, P388 mouse leukemia, was not 1 of them. ...
.
As he had predicted, these compounds were not effective against mouse leukemia
.
SRB reasonably suggested that NCI try the Antineoplastons in cell-culture assays that were similar to "human solid tumors, especially adenocarcinoma of the breast" ...
.
SRB was hardly alone in voicing doubts about the P388 mouse model
.
1983 - Ironically, it was Dr. John Vendetti himself, chief of the NCI's Drug Evaluation Branch, who coauthored an article in which he argued the limitations of this very mouse system
.
Scientists at NCI had found, for instance, that of 79 drugs which had previously been judged negative in the P388, 14 showed "significant activity" when retested in cell culture assays [1] [2]
.
5/6/1983 - Dr. B. applies to FDA for an IND (Investigational New Drug) permit, to conduct clinical trials on antineoplastons
.
Most INDs are approved within 30 days
.
5/9/1983 - FDA writes in a motion for summary judgment that if Judge McDonald does not rule as it wishes,
.
"...the government would then be obliged to pursue other less efficient remedies, such as actions for seizure and condemnation of the drugs or criminal prosecution of individuals..."
[3]
.
5/24/1983 - In 1983, the FDA obtained an injunction from a federal district court prohibiting Dr. B. & the BRI from shipping antineoplastons in interstate commerce without 1st obtaining FDA approval
See US v. BCRI, No. H-83-2069 (S.D. TX) (order granting permanent injunction)
.
The injunction, however, didn't preclude intrastate distribution of antineoplastons [4] [5]
.
Acting upon information gathered in the course of previous FDA investigations of Dr. B. & others, & upon information supplied to him by named individuals & confidential informants, Ewing, Miller, & other federal employees pursued a new investigation of Dr. B. to determine if he had violated the Act & other federal criminal statutes by failing to adhere to the requirements of the permanent injunction entered by the district court 5/1983 [6]
In.1983, the FDA barred Dr. Burzynski from interstate transactions involving antineoplaston treatments [7] [8]
.
US District Court Judge McDonald ruled that Federal law did not prohibit Burzynski from treating patients with antineoplastons within Texas although he could not ship them across state lines
.
This was a setback for the FDA;
.
soon another government agency, the US Attorneys office, began a Grand Jury investigation
.
After some early activity this investigation died down [9]
.
5/31/1983 - FDA denies Dr. B's request for an IND, stating that he does not have sufficient "training or experience"
Dr. B. is an MD PhD in biochemistry who conducted NCI-funded cancer research at Baylor College of Medicine for 7 years, & had at this point run his own cancer clinic for 6 years
.
6/13/1983 - Dr. B. re-applies to FDA for IND, responding to.5/31/1983 refusal letter
.
7/7/1983 - FDA Associate Commissioner Robert Wetherell Jr. writes to US Representative Robert W. Davis that Judge McDonald's injunction
.
"does not prohibit the distribution of antineoplastons within the State of Texas."
.
9/21/1983 - Unscheduled visit by FDA agents who demand several hours from Dr. B., despite being told his schedule is full with gravely ill cancer patients
.
Dr. B. has to reschedule several patients to later in the week
.
The agents insist on coming back a 2nd day during which the schedule is again full of patients, & refuse Dr. Burzynski's offer to meet with them on a day in which no patients had been booked
.
Fall, 1983 - Dr. B. hires Carl Bruch, PhD, former Chief Scientist of FDA's Bureau of Medical Devices, to bring manufacturing of antineoplastons into compliance with FDA standards
.
12/15/1983 - FDA again denies IND application
.
2/1984 - FDA again denies IND application [3]
.
Dr. Burzynski's own testimony demonstrates that the FDA notified him 2/1984 that it found deficiencies in his IND application & required additional data
Thus, he has failed to make a good faith effort to obtain an IND or to exhaust his administrative remedies
His claim for injunctive relief with respect to his IND was, therefore, properly dismissed [6]
.
5/24/1984 - Judge Gabrielle K. McDonald of the US District Court for the Southern District of TX partially granted the request of the US for a permanent injunction
.
Judge McDonald's order prohibited SRB from distributing his antineoplastons treatment in interstate commerce, but did not forbid intrastate distribution of the drug [8]
.
8/3/1984 - Dr. Bruch reports that Dr. B's manufacturing procedures meet FDA GMP (Good Manufacturing Practices) [3]
We’ll talk about dissemination of false information by the FDA
1985 - the FDA tells anyone who calls inquiring about Dr B. that he’s being “criminally investigated”
When the judge on the case found out about that he issued a cease & desist & a strong reprimand against that
The FDA now has refined this tactic
Instead of waiting for people to call up the FDA, what they’ve done is subpoena all the records from Dr. B. about his business associates & all the researchers around the world, & there are many of them who are researching antineoplastons, his therapy
Now what they’re doing, is systematically contacting, everyone who does business with them or who may do business with him, & telling about the grand jury investigation & subpoenaed documents
I believe that they’re doing this in order to make it more difficult for him to do business”
“I’d like the following questions to be asked of the FDA
How much money have they spent in the last 10 years to try & put Dr. B. out of business?
How many documents can they subpoena, & how many more grand juries does he have to go to?
And why can’t patients, who have advanced cancer, seek the medical treatment of their choice?”
Bruzynski’s defense attorney arguing his case
1995: “In 1985, the FDA convened a grand jury to hear evidence to try & indict Dr. B.
.
7/17/1985 - FDA agents, along with members of Harris County Sheriff’s office, barged into Burzynski’s clinic seizing over 200,000 documents (research papers, patient records) & confiscating 11 file cabinets, including all patient medical records [1]
.
They loaded everything into a U-Haul and drove away [10]
.
Little difficult to practice medicine when you don’t have medical records”
.
In order to continue treating patients, Dr. B installs copier at his expense at FDA office & must make appt. in advance to copy them as needed [1]
.
This was just the beginning of Dr Burzynski’s troubles
.
Over the next 12 years he would be driven to the point of bankruptcy battling the FDA, insurance companies, the TBME & Health Department, & the postal service for charges of mail fraud
.
SRB's lowest point was sitting in a courtroom facing up to 270 years in prison for saving lives that no other person on earth could help [10]
.
(It took nearly 14 years to recover those records)
2 years later, in 7/1985, as part of a criminal investigation based on a referral from the FDA to the DoJ, the government applied for & obtained a warrant to search an office complex that, as the warrant stated, housed the administrative offices of Dr. B. & the BRI, Incorporated, a separate legal entity from BCRI, which had been a defendant in the civil action
.
10/23/1985 hearing (the hearing on the preliminary motions) [6]
.
10/24/1985 - Judge McDonald tells FDA to stop releasing misleading & inappropriate information about Dr. B..
As a result of FDA's letters to insurance companies, income has fallen off sharply, the production of medicine is interrupted, & patients suffer severely
.
12/18/1985 - Mitchell Yokuyama MD, of the Antineoplaston Study Group at Kurume University in Japan, writes FDA requesting permission for Dr. Burzynski to export a small quantity of antineoplastons to Japan for experimental use [3]
.
1986 - Huey Roberts, a resident of Oregon, developed cancer of the esophagus
Radiation treatments & chemotherapy did not reverse the progress of the disease [8]
.
1986 - "One of Dr. B's patients sued their insurance company, Aetna, for payment of treatment
Dr. B. joined the suit & was then countersued by Aetna & charged with racketeering." [9]
.
Dr. B's attorney continued:
.
1986 - “They presented the evidence to the grand jury. Federal Grand Jury investigation of Dr. B. dissolves with no indictment
.
Apparently FDA is unable to find any evidence Dr. B has shipped drugs out of state
.
Nevertheless, FDA refuses to release the seized documents, which have not been returned
.
Dr. B's attorney continued:
.
they come back, seize another 100,000 documents
.
The TMB has been trying since 1986 to revoke Burzynski's medical license for, I guess, curing cancer instead of just treating it like the rest of the medical community
.
4/17/1986 - FDA writes Dr. B, denying his & Kurume University's request to allow Dr. B. to send antineoplastons to Japan for experimental use
.
2/12/1987 - Dr. Burzynski & 2 professors from the Medical College of Georgia meet with FDA officials in Washington &, in support of the IND application, present:
.
2 sound theoretical models explaining anti-cancer activity of antineoplastons in humans
.
3 studies showing anti-cancer activity of antineoplastons in animals [3]
.
2 years later, in 7/1985, as part of a criminal investigation based on a referral from the FDA to the DoJ, the government applied for & obtained a warrant to search an office complex that, as the warrant stated, housed the administrative offices of Dr. B. & the BRI, Incorporated, a separate legal entity from BCRI, which had been a defendant in the civil action
.
During a 12-day hearing on the motion for a temporary restraining order & contempt ruling,
.
Dr. B. has been allowed to install a copying machine in the FDA offices in Houston where the seized patient treatment records are being held & has made copies of those treatment records that he desires
.
In 1 respect, however, the fact that Dr. B. & his patients were denied any opportunity for discovery has unfairly prejudiced their opportunity to allege facts in support of counterclaims that may entitle them to relief
.
The district court found that at least 2 statements made by Ewing in response to inquiries about Dr. B. & his treatment were "near to inappropriate," exceeded "his duties & responsibilities as an officer of the FDA," & misled his audience by asserting, as established fact, charges still subject to investigation
.
The district court also noted that, by showing that such statements were made to at least 1 insurance company, Dr. B. & his patients demonstrated that "the above conduct has had an impact on their ability to treat patients because over 50% of [the Institute's] income is derived from insurance payments"
.
Whether additional examples of such questionable conduct exist &, if so, in numbers justifying injunctive relief can only be discerned through discovery
.
The claim seeking an injunction to stop the government from disseminating false or misleading information to outside parties, therefore, should not have been dismissed until Dr. B. & his patients had an opportunity to discover the scope of the problem & to provide evidence that an injunction is necessary
.
For the reasons given, the judgment of the district court is AFFIRMED in part, REVERSED in part, & REMANDED for further proceedings consistent with this opinion [6]
US v. BCRI, 819 F.2d 1301 (5th Cir.)
See US v. BCRI, 819 F.2d 1301, 1315 (5th Cir.)
1987 - reh'g denied, 829 F.2d 1124 (5th Cir.) [8]
.
10./28/1987- In spite of Feb. meeting, FDA again denies IND request
.
11/17/1987 - Dr. B responds to 10./28/1987 denial with more data & explanations
.
1/13/1988 - FDA states in a letter that it now believes antineoplastons have shown anti-cancer activity, but again deny IND request, demanding further testing
.
1/4/1989 - FDA Commissioner Frank Young issues a public statement to demonstrate how quickly FDA approves cancer drugs
.
He says that it is a "misperception" that FDA insists on "particular designs of trials, or that large numbers of patients are needed
.
In fact, cancer drugs have been approved on extremely small databases (well under 100 patients), with responses in less than 10, & on the basis of studies whose design was anything but classic."
.
He adds that in at least 1 case, a cancer drug was approved on the basis of only 6 responses
.
1989 - Following a trip to Japan to verify the Japanese studies showing anti-cancer activity of antineoplastons, FDA finally allows Dr. B. to begin testing 1 oral preparation of antineoplastons [3]
.
3/16/1989 - the FDA approved SRB's request for an IND permit to do a phase II clinical trial at an independent institution on the effect of antineoplaston therapy on 15 patients with metastatic breast cancer [1]
.
10/13/1989 - Stanislaw R. Burzynski, M.D., Ph.D. of Houston has won an important round in his battle against the Aetna Life Insurance Company
.
An Illinois judge has ruled that Aetna's attorneys overstepped their bounds by seeking confidential records of patients from other insurers
.
He ordered them to pay over $11,000 in legal fees to Abady & Jaffe, the NY law firm that represents the Houston doctor
.
Aetna had originally sought such records as part of its $600,000 RICO suit against SRB, the discoverer of antineoplastons
.
Grace Monaco is Aetna's consultant on the case
.
The present suit arose when the court twice refused to allow Aetna's attorneys to see complete medical records of patients covered by other companies
.
It did allow them to see some such records, provided that all private information was deleted
.
Frustrated by these restrictions, Aetna's attorneys
.
"decided that it was perfectly okay to go to these insurance companies directly... & seek information from them," in the words of US District Judge Michael Mihm
.
Aetna's attorneys, Hinshaw & Culbertson, had a Springfield, Illinois clerk send subpoenas to fellow insurance companies
.
10/13/1989 - "It's a little hard for me to understand why legal issues would be assigned to secretaries & clerks," the judge stated in his decision
.
The other insurance companies thought they were facing
.
"an official mandate of the Court," said the judge
.
The result was that the attorneys received private records of Dr. B's patients in disregard not just of the judge's orders but of confidentiality
.
"I'm very troubled" by this situation, the judge told the lawyers in a phone conference, calling their indifference to his order "almost unconscionable"
.
Judge Mihm did not disqualify Aetna's attorneys from the case
.
But he ordered them to pay Abady & Jaffe's fees in connection with this complaint
.
He also barred Aetna from any use of this information & ordered the data segregated [11]
.
6/1990 - SRB's attorneys, Abady & Jaffe, fought back with a racketeering charge against Aetna, & "quackbuster" Grace Powers Monaco, who has served as Aetna's consultant on their suit [9]
.
I visited Hideaki Tsuda, M.D., an anesthesiologist, & his colleague, a surgeon named Hiroshi Hara, M.D., at Kurume University School of Medicine in Japan
.
Tsuda had known SRB when they were both at Baylor University & had a friendly regard for him, but it was the high regard of a medical colleague, not a "true believer"
.
Tsuda had subsequently decided to do an independent evaluation of antineoplastons in both animals & humans
.
He & Hara & almost a dozen other colleagues formed the Antineoplaston Study Group
.
He had the advantage that Burzynski had foregone:
.
A hospital setting & a university appointment
.
He had the further advantage that Japanese law made it much easier for him to proceed from animal studies to patient studies
.
Japan's enlightened universal system of health insurance pays for most of the costs of patient care for virtually all Japanese, so that the costs of observing a clinical series of patients given antineoplastons is relatively modest
.
In the course of 2 studies with mice, in which they demonstrated both tumor prevention & inhibition, Tsuda, Hara, & their colleagues resolved to their own satisfaction the issue that had troubled the Canadian oncologists with respect to animal studies of antineoplastons
.
They acknowledged the discrepancies between animal & human studies regarding the effectiveness of A10, but speculated that the explanation might rest in the fact that antineoplastons are not naturally occurring in mice & are excreted rapidly, whereas humans show longer retention times
.
They therefore adopted a more frequent & larger dose in the athymic mouse study, reasoning that the smaller doses might be sufficient to prevent tumor formation, but not to inhibit an existing tumor
.
They concluded:
.
A-10 & A-10 Injection are quite different from conventional chemotherapeutic agents because they are both naturally occurring in humans though not existing in animals
.
Accordingly in experimental studies, a larger & more frequent dose will be required to demonstrate quantitative antitumor effects
.
An improved effect can be expected in clinical cases from the same dosage levels as evaluated experimentally
24 K. Hashimoto et al., "The Anticancer Effect of Antineoplaston A-10 on Human Breast Cancer Serially Transplanted to Athymic Mice," Journal of the Japan Society for Cancer Therapy 25(1):1-5 (1990)
http://www.ncbi.nlm.nih.gov/m/pubmed/2157780
.
http://www.abstractboard.com/abstract/2157780/The-anticancer-effect-of-…
7 - 8/1990 - 1 case, which Tsuda has reported publicly, was described in the 7 - 8/1990 issue of Oncology News 16(4):1,6 (1990)
.
At a Swiss conference that is discussed further below, Tsuda reported that his group had administered a combination of cisplatin & antineoplastons to an elderly woman with inoperable metastatic ovarian carcinoma with massive ascites:
.
Independent studies by Dvorit Samid, Ph.D., at the Uniformed Services University of Health Sciences in Bethesda, Maryland, that had shown that "AS2-1 profoundly inhibits oncogene expression & the proliferation of malignant cells without exhibiting any toxicity toward normal cells. ...
.
The Antineoplaston can actually induce terminal differentiation [reversion toward normal cellular structure]. ... `
.
Such a dramatic phenomenon is seldom seen,' Dr. Samid noted
Oncology News 16(4):1,6 (1990)., 1
.
At the same conference, Burzynski reported a phase II trial of AS2-1 (that Samid had tested) combined with the hormonal regimen DES (diethylstilbestrol) in 14 patients with prostate cancer resistant to hormonal therapy:
.
"By the end of the study we were able to identify 2 cases of complete remission, 3 partial remissions, 7 objective stabilizations, & 2 cases of progressive disease'
.
Clinical improvement was accompanied by a drop in prostate cancer markers & by improvements in bone scans [1]
For details, see abstracts in proceedings of 9th International Symposium 26 Ibid., 1., Switzerland, 26-8 March 1990
Oncology News 16(4):1,6 (1990), 6
.
1990 - FDA initiates a 2nd long Grand Jury investigation
.
Again, thousands of documents are subpoenaed & many employees are subpoenaed to testify, including Dr. B.
.
1990 - Again, no indictment is returned [3]
.
or the third,
.
They present more documents, & Dr. B. testifies extensively before the grand jury, no indictment
.
The antineoplastons were part of B's legal problems in the 90s when he was indicted on fraud charges
.
After a trial that made worldwide headlines, he was cleared of any wrongdoing
.
9/1991, NCI sent a site visit team to Dr. B's clinic in Houston
10/6/1991 - an NCI site visit team reviewed a best-case series of results using antineoplastons with brain tumors at the BRI [1]
.
Dr. B. hosts a team of 6 NCI scientists who spend a day exhaustively reviewing the records of 7 "terminal" brain cancer patients treated with antineoplastons
.
The team concludes that 5 of the 7 have had complete response (disappearance of tumor) & 2 partial response
.
Its report states unequivocally that "anti-tumor activity was demonstrated in this best-case series..." [3]
.
After reviewing 6 cases, they concluded that his results in brain cancer were as good as any they had seen in 20 years
.
Within months there was was an intensification of attacks in the Journal of the American Medical Association, & elsewhere
.
Real cancer quacks are self-defeating
.
Their unethical behavior refutes whatever good results they may obtain by their sheer temerity
.
By contrast, it has been Dr. B's insistence on an objective test of his compounds & concepts (while he continues to treat patients) that has gotten him into all this trouble
.
It is his insistence of doing things the scientific way that has made him the flashpoint for the whole cancer war
.
That is why the enemies of alternative medicine are fighting so fiercely to destroy him, regardless of the deadly effects on 300 cancer patients today, & the immeasurable harm to the patients of tomorrow [24]
.
1991 - 1993: FDA investigates Dr. B., we don’t know if evidence was presented to another grand jury
.
12/1991 - growing interest on the part of mainstream cancer researchers in SRB's work & increasing evidence of antineoplaston's effectiveness in some cancers led to the announcement 12/1991 of NCI-sponsored phase II trials of antineoplastons with brain cancer patients
.
8/11/1992 - 967 F.2d 1063: Stanislaw R. Burzynski, M.d., & BRI Inc., v. Aetna Life Insurance Company, et al., US Court of Appeals, 5th Circuit
Appeal from the US District Court for the Southern District of TX
.
The district court dismissed Dr. Burzynski's entire complaint, with prejudice, on the grounds that certain alleged conduct which supported the complaint was protected by an absolute discovery privilege under Texas law arising from the related suit
.
Alternatively, the district court dismissed, without prejudice, each of Dr. B's 11 pleaded counts
.
We find that the district court's application of the Texas discovery privilege was improper under the pleaded facts
.
A consequence of this holding is that the dismissal without prejudice becomes either erroneous or premature
.
We, therefore, reverse & remand [7]
.
1992 - Burzynski v. Aetna Life Ins. Co., 967 F.2d 1063 (5th Cir.)
1992 - See Burzynski v. Aetna Life Ins. Co., 967 F.2d 1063, 1064 (5th Cir) [8]
.
1992 - Stanislaw R. Burzynski M.D., & BRI Inc., v. Aetna Life Insurance Company, et al., HNo. 91-2385. US Court of Appeals, 5th Circuit. 1992-08-11 [12]
.
10/1992 - the NCI is scheduled to conduct clinical trials with Dr. S. R. Burzynski's antineoplastons
.
Antineoplastons are peptides which Burzynski claims constitute a biochemical defense system in the body
.
NCI has announced that several medical institutions will take part in the trial
.
Impetus came from an NCI trip last fall, in which site visitors concluded that SRB's treatment had indeed successfully shrunk 7 cases of brain tumor
.
"We are trying to ascertain in a scientific way," NCI said, "the real value of antineoplastons
.
Are they of benefit to cancer patients?"
.
There will be 4 independent trials, each involving 25–30 people with different types of brain tumors
.
3/1992 - In late March, Aetna's 5 year suit against Burzynski was thrown out of court
.
6/3/1992 - THE JAMA GAME: the Journal of the American Medical Association launched a full-scale attack with an article on Burzynski by Saul Green, PhD, entitled "Antineoplastons—An Unproved Cancer Therapy."
.
JAMA didn't mention that Green was scientific director of Emprise, involved in the Aetna suit
.
SRB has submitted a rebuttal to JAMA with 137 references
[THEY NEVER PUBLISHED IT] [13]
.
Dean Mouscher (Compuserve's Cancer Forum, CIS #70401,1236) spent many months searching for a treatment for his father's brain cancer
.
He finally settled on Dr. Stanislaw Burzynski's peptide treatment, antineoplastons
.
11/1992 - In November, Dean sent this letter to Texas Attorney General Dan Morales, who engaged in efforts threatening to take away Dr. Burzynski's medical license
.
I investigated Dr. Burzynski for my father, who is suffering from glioblastoma multiforme, a viciously aggressive brain tumor that rarely responds to radiation or chemotherapy, & then only briefly
.
It is basically a death sentence....
.
I spoke to] Dr. Patronas, an NCI neuroradiologist with 20 years experience, whose knowledge of Dr. B. came not from rumors but from a site visit during which he audited a number of cases
.
He told me that he believes in SRB's results, that he found the evidence "extremely impressive," & that "in 20 years in this business I haven't seen anything that looks so promising."
.
But the most impressive evidence...is my father himself
.
11/9/1992 - A scan taken shows that the tumors have stopped growing & that there is some necrosis [tissue death] within 2 of the 3 tumors
.
That is the opinion not only of Dr. B., but also of Dr. Michael Gorey, the radiologist at Evanston Hospital here
.
And in fact, my father's neurological condition—which had been declining rapidly—seems little changed since he began taking Dr. B's antineoplastons
.
I would be happy to send the radiology reports at your request [14]
.
1993 - Dr. B. receives permission from FDA to test intravenous antineoplastons to treat brain cancer, & begins clinical trials
.
5/24/1993 - Nicholas Patronas MD, NCI's Chief of Neuroradiology & the leader of the 1991.team that audited Dr. B's brain tumor results, testifies in an Austin courtroom that antineoplastons are the most effective treatment for brain tumors he has ever seen
.
When asked what will happen to patients if they are deprived of access to the drug, Dr. Patronas replies,
.
"I think these patients will die."
.
5/28/1993 - When Dr. Patronas returns to Washington he is severely reprimanded for having supported Dr. B.
.
5/28/1993 - under pressure, he withdraws a paper on antineoplastons he was scheduled to present at an international cancer conference in Sweden
.
2/1994 - Dr. B. sends letters to approx. 12 large pharmaceutical companies asking them to participate in joint development of antineoplastons
All decline - possibly due to fear of retaliation by FDA [3]
.
3/1994 - Dr. B. hosts Shlomo Flechter MD, a neurologist at Israel's famed Weizmann Institute, who is interested in conducting clinical trials of antineoplastons [3]
.
3/10/1994 - Stanislaw R. Burzynski, MD, PhD, won a major victory in his battle to keep practicing medicine in the state of Texas (5/1994 7/28/1994)
3/10/1994 - See In re Burzynski, no.503-92-529 (Texas SOAH)
.
The state ALJ's ruling was issued after this case was orally argued in this Court [4]
.
An administrative law judge ruled that SRB can continue to treat cancer & AIDS patients in his Houston clinic with his new class of non-toxic medicines called antineoplastons
.
This ruling came despite another Texas law that supposedly prohibits people from distributing or prescribing drugs that have not yet been approved by the FDA
.
The judge's ruling had been requested by the SBME
.
But Judge Earl A. Corbitt upset their plans
.
He ruled that the TMPA allows physicians to prescribe "any drug" to minister to the immediate needs of their patients
.
This right, he said, takes precedence over the general provisions of the Texas FDCA, which allegedly make it a crime to manufacture, distribute, or prescribe drugs not approved by the FDA
.
"The decision," says Dr. B.'s attorney, Richard Jaffe, "strikes a significant blow for freedom of choice"
.
Corbitt's decision will stand unless the board changes it for matters of policy
.
"The decision is life-saving for many of Dr. Burzynski's advanced cancer & AIDS patients," said Jaffe
.
The ink was hardly dry on this historic ruling, however, when the US Attorney's office in Houston stepped up its harassment
.
For almost 10 years, Burzynski has been investigated by various US Attorneys & Grand Juries in Houston
.
Over the years, at least 5 different Grand Juries, 3 consecutive US attorneys, & 5 assistant US attorneys have been involved
.
SRB employees & family members have repeatedly been called to testify
.
Dr. B. himself has been called twice
.
Yet these investigators have never been successful, except in wasting time & energy
.
In fact, after SRB testified 3 years ago, the result was not an indictment, but a pink slip for US Assistant Attorney, Philip Hilder
.
During Easter/Passover week this year, however, there was stepped-up activity
.
Numerous current & former employees are again being subpoenaed to testify
.
Are antineoplastons really a "useless cancer remedy?
.
Not according to NCI, which conducted a site visit 9/1991 that validated the effectiveness of these drugs in some cases
.
In fact, the OAM/NIH has now arranged for clinical trials at Sloan-Kettering, the Mayo Clinic, & NCI itself
.
And not according to 100s.of Dr. B's devoted patients
.
However, cancer & AIDS patients are legally allowed to take home a 3 months' supply of medicine for their own use, & frequently do so
.
Word about antineoplastons is spreading in this way
.
4/1994 - In late April, the US Attorney's office launched an attack on one of Dr. B's most prominent local supporters, the Harris County Attorney, Mike Driscoll, who is also a board member of the BRI
.
SRB had treated Driscoll's wife, Betty Rose, who had cancer
.
The Grand Jury subpoenaed copies of the last 10 years of Driscoll's campaign records, which showed that Dr. B. made donations of about $1,000 per year to Driscoll's campaign
.
There was no crime or impropriety in this, however
.
"Many folks on the local political scene are well aware of Driscoll's devotion to his late wife during her illness," wrote the Houston Business Journal, "& his appreciation for Dr. B's efforts to save her
.
4/20/1994 - "It called the attempt to insinuate corruption "ham-handed"
.
4/20/1994 - In fact, these reports are part of the public records & can be readily obtained by anyone, according to the Houston Post
.
So why all the grandstanding?
.
Driscoll believes it is "to discredit him in connection with grand jury testimony about Dr. B."
.
According to attorney Jaffe
.
"Several grand jurors asked him what he thought of SRB, & why
.
4/20/1994 - He told them that he basically believes Dr. B. is helping people, saving lives, & was a good man" (Houston Insider)
.
1980s - the Aetna Insurance Co. sued SRB for fraud
.
This case was eventually thrown out of court, but not before SRB countersued for over $100 million
.
In fact, the government's case against SRB is virtually identical to the old Aetna suit [15]
.
1994 - Trustees of the Northwest Laundry and Dry Cleaners Health & Welfare Trust Fund, v. Stanislaw R. Burzynski, No. 93-2071. US Court of Appeals, 5th Circuit. 1994-07-28. 27 F.3d 153 [16] [17]
.
2. "Simply stated, antineoplastons are a special class of peptides, found in the blood, that combat neoplastons--abnormal cells or cancer cells." Trustees of the Northwest Laundry v. Burzynski, 27 F.3d 153, 155 n.1 (5th Cir. 1994), cert. denied, 115 S. Ct. 1110 (1995) [4]
.
1994 - In the Matter of the Complaint Against Stanislaw R. Burzynski M.D., Ph.D. Before the TSBME. Order. 1994-08-31 [18]
.
6/1994 - Burzynski Clinic sends letters to 2,000 neurosurgeons asking for patient referrals in order to speed up the clinical trials [3]
.
6/3/1994 Antineoplaston (Dr Samid) [
.
1994 - FDA initiates 3rd Grand Jury investigation of Dr. Burzynski
.
1994 - Again, no indictment is returned
.
The Houston press reports that Assistant US Attorney Jim Powers is reassigned due to prosecutorial misconduct during the investigation [3]
.
9/1994 - This summer, Dr. Samuel Broder, MD, director of the NCI, co-authored an article in a major medical journal containing optimistic claims about a new approach to cancer treatment
.
But the whole story is not told in Dr. Broder's article
.
For he fails to mention the fact that in part this new treatment is based on the life work of Houston physician, Stanislaw R. Burzynski, MD, PhD
.
6/3/1994 - The article in question appeared in the Journal of the American Medical Association (1994; 271:1693-1695)
www.ncbi.nlm.nih.gov/m/pubmed/8182856
.
http://jama.jamanetwork.com/article.aspx?articleid=373728
It was co-authored by the NCI director & his colleague, Judith E. Karp, MD
.
They reviewed some recent progress in controlling the expression of so-called ras-oncogenes (growth-regulating genes) & "ras-encoded proteins" in influencing the outcome of various human cancer
.
1982 - Ras genes, similar to animal viruses, were 1st discovered in human cancers (Der CJ et al. PNAS 1982;79:3637)
Three human transforming genes are related to the viral ras oncogenes
www.ncbi.nlm.nih.gov/pmc/articles/PMC393767
.
www.ncbi.nlm.nih.gov/pmc/articles/PMC393767/pdf/pnas00634-0023.pdf
This is widely considered a major breakthrough in understanding the genetics of cancer
.
Ras oncogenes make some of the proteins that are responsible for regulating the health & appearance of the proteins that are found on the surfaces of cells
.
When these genes mutate, & their protein products become abnormal (become "overexpressed or deranged" is the technical terminology), they can "serve as critical driving forces in the evolution of many...cancers," wrote Drs. Karp & Broder
.
By blocking such cell-surface changes, scientists hope to "provide a powerful molecular target for therapy & prevention of a broad spectrum of malignant neoplasms." including those of the colon, pancreas, prostate, bladder, lung, brain, & possibly also breast cancer
.
The NCI scientists then cite 3 new investigational agents that seem able to help preserve normal cell membrane structures & functions
.
We needn't discuss the 1st 2 here
.
The 3rd, phenylacetate, targets a particular site on the cell surface, the scientists write, & thereby inhibits ras-driven cancerous cell growth
.
In addition, it "could theoretically exert an antitumor effect, even in the absence of ras abnormality."
.
It should be noted that of the 3 agents, only phenylacetate naturally occurs in the human body; the other two are foreign substances
.
"Some of these approaches," Drs. Broder & Karp say, "could yield new cancer prevention strategies....
.
These agents are presently in clinical development for prostate cancer & glioblastoma multiforme" & "several important clinical studies are under way"
.
A quick check of the footnotes reveals that some of the work in question is being done by Dvorit Samid, PhD, herself presently at NCI (J Clin Invest 1993; 91:2288-2295)
.
Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate
www.ncbi.nlm.nih.gov/m/pubmed/8486788
.
www.ncbi.nlm.nih.gov/pmc/articles/PMC288233
.
http://m.jci.org/articles/view/116457
.
http://m.jci.org/articles/view/116457/pdf.mobile
.
www.jci.org/articles/view/116457/pdf.mobile
.
www.jci.org/articles/view/116457
.
http://static.jci.org/content_assets/manuscripts/116000/116457/JCI93116…
Dr. Samid is currently involved in the NCI clinical trial of phenylacetate as a new treatment for brain cancer
.
4/1992 - Phenylacetate: a novel nontoxic inducer of tumor cell differentiation
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534
8/1992 - Increased fetal hemoglobin in patients receiving sodium 4-phenylbutyrate
www.ncbi.nlm.nih.gov/m/pubmed/1378939
.
With the oblique reference to Dr. Samid, Drs. Karp & Broder reveal the hidden sources of their ideas
.
For this work on phenylacetate is derived from the work of Dr. B.
.
Yet there is no mention of SRB in Broder's account
.
The real story is this:
.
In 1988, at the urging of a prominent cancer activist named Bob DeBragga, Dr. Samid began investigating the work of Dr. B., who was one of DeBragga's doctors
.
Samid was then of the Uniformed Services University of Health in Bethesda, MD
.
She began to experiment with synthetic analogs of the urine-derived antineoplastons, & particularly with the one called AS2-1
.
7 - 8/1990 - In Oncology News, she is quoted as saying,
http://curezone.com/diseases/cancer/antineoplastons.asp
"AS2-1 profoundly inhibits oncogene expression & the proliferation of malignant cells without exhibiting any toxicity toward normal cells...
.
The Antineoplaston[s] can actually induce terminal differentiation [i.e., reversing malignancy]....
.
Such a dramatic phenomenon is seldom seen."
.
Phenylacetate, as she learned from Dr. Burzynski, is the main ingredient of AS2-1
.
While her earlier articles bore no mention of this intellectual debt, in her most recent paper, she says, she is able to credit Burzynski as a source of her work
.
Samid D, Yeh TJ, Shack S. Interferon in combination with anti-tumorigenic phenyl derivatives: potentiation of α-IFN activity in vitro. Br J Haematol 1991; 79Suppl. 1: 81–3
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.1991.tb08127.x/a…
Cited in:
1999 - 2. Jan C. Buckner, Mark G. Malkin, Eddie Reed, Terrence L. Cascino, Joel M. Reid, Matthew M. Ames, William P.Y. Tong, Silam Lim, William D. Figg, Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma, Mayo Clinic Proceedings, 1999, 74, 2, 137
.
1992 - 4. Hideaki Tsuda, Shigetaka Sugihara, Hiroyuki Nishida, Hiroshi Hara, Naofumi Eriguchi, Kiyoshi Ishii, Kiyoshi Sasaki, Shinsuke Yoshimura, Noriho Tanaka, 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, Cancer Science, 1992, 83, 5
.
1992 - Samid D, Shack S, Sherman LT. Phenylacetate: a novel non-toxic inducer of tumor cell differentiation. Cancer Res 1992; 52: 1988–92
.
4/1/1992 - Phenylacetate: A Novel Nontoxic Inducer of Tumor Cell Differentiation
www.ncbi.nlm.nih.gov/m/pubmed/1372534
.
http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf#page=1
.
http://m.cancerres.aacrjournals.org/content/52/7/1988
.
http://cancerres.aacrjournals.org/content/52/7/1988.abstract?sid=be2d50…
.
http://cancerres.aacrjournals.org/content/52/7/1988.full.pdf?sid=29b3d0…
"Basically," Burzynski says, "through the elucidation of the mechanism of action of ras-oncogenes, my theory of the Biochemical Defense System has been proven, as far as the 1st ingredient, phenylacetate, is concerned
.
The human body can defend itself against cancerous growth by using this body substance, phenylacetate, which interferes with the information processing in ras-oncogene pathways"
.
Ironically, Burzynski remains under fierce attack by state regulators, especially the TBME
.
Broder could greatly help the situation by properly acknowledging the parentage of his own ideas
.
We would hate to think that this article by Drs. Broder & Karp is yet another `rip off' of an alternative pioneer by the cancer establishment
.
At NCI, this process is sometimes euphemistically called "separating the medicine from the man" [20]
.
5/1993 - a 2-day hearing was held before an administrative law judge, Earl Corbitt
.
His ruling was to serve as a recommendation to the TSBME
.
Corbitt eventually ruled that antineoplastons were indeed necessary to meet the patients' immediate needs for survival
.
5/24/1993 - He received testimony from Dr. Nicholas Patronas, the chief of Neuroradiology at NCI, who led a site visit for the government in which it was concluded that Burzynski's treatment was in fact effective in the treatment of some cases of brain cancer
.
He also heard from several patients who claimed to have greatly benefitted from the nontoxic peptide treatment
.
Corbitt concluded that the State had not offered any evidence to the contrary
.
8/1994 - the TSBME met again & emphatically rejected Judge Corbitt's decision
.
They ruled that the mere survival of patients did not qualify as an "immediate need" under the law
.
Therefore, according to the Board, Dr. B. had been breaking the law by giving this treatment to his patients outside the context of FDA trials
.
In a decision that outraged defenders around the world, the Texas Board put this innovative researcher on probation for 10 years
.
This was a sword of Damocles over his head & that of hundreds of anxious patients
.
Dr. Burzynski, through his veteran lawyer, Richard Jaffe, appealed the Board's decision to Texas District Court Judge Paul Davis
.
They expected a long & drawn out struggle
.
Thus, even his most ardent supporters were surprised when Judge Davis ruled from the bench (i.e., immediately) to reverse the Board's decision
.
He called their decision:
.
"In excess of the agency's statutory authority, not reasonably supported by substantial evidence, capricious or arbitary, & characterized by abuse of discretion"
.
It is now up to the Texas medical board to decide whether or not it will appeal this stinging rebuke
.
If they do, as now seems likely, Burzynski supporters say they are likely to be dealt an even more definitive rejection of the notion that Texas patients are too stupid to make their own choices in cancer care [21]
.
11/1994 - Dr. B. reaches an agreement of Lori Kunkel MD of UCLA to conduct clinical trials of antineoplastons in the treatment of lymphoma
.
1994-1995 - FDA delays more than 9 months before finally responding to Dr. B's request for permission to have Dr. Kunkel of UCLA conduct clinical trials
.
By the time FDA finally responds, Dr. Kunkel has left UCLA, & those studies are never conducted [3]
.
1995, another grand jury.”
.
2/3/1995 - Friday, an Austin judge ruled that SRB, 1 of the country's leading alternative doctors, could continue to practice medicine in the state
.
This came as welcome news to the staff of the Institute, as well as to more than 200 people with cancer & AIDS who believe their lives depend on their continued access to antineoplastons
.
Burzynski discovered these natural, non-toxic peptides in Poland more than 2 decades ago
.
They are currently under examination worldwide, including at the NCI, MSKCC, & the Mayo Clinic
.
The TSBME initiated this action several years ago, when it charged Dr. B with violating Texas law by treating patients with drugs that are not approved by the US FDA
.
Burzynski replied that the TMP act authorized him to treat patients with any necessary drugs
.
The law reads that "a physician licensed to practice medicine under this Act may supply patients with any drugs, remedies or clinical supplies as are necessary to meet the patients' immediate needs."
.
3/23/1995 - FDA agents Hansen & Biegelman pay unscheduled visit to the Long Island home of SRB brain tumor patient Domenick Pugliese
.
They have no search warrant, but aggressively insist on searching the home, telling the family they have been trying to "get" Dr. B. for 10 years
.
The agents insist the treatment is ineffective & suggest the family seek other treatment
.
When the family refuses to cooperate, the agents threaten several times to return with a subpoena
.
3/24/1995 - Friday, the BRI in Houston, TX was raided by 7 agents of the FDA & the US Postal Service & confiscates boxes of records, including patient medical records
.
The government agents herded BRI employees into a back room & then attempted to seize the medical records of 17 patients
.
Only 9 names corresponded to active Burzynski patients
.
The FDA also took the names & phone #s of all current clinic patients
.
Off the record, FDA employees have told us that such a raid had to have been planned far in advance
.
But, even so, it may have been triggered by 2 media events
.
3/1995 - In mid-March, Stanislaw R. Burzynski, MD, PhD, director of the clinic, had appeared on the "Eye on America" segment of the CBS Evening News
.
3/24/1995 - The response to this report was so overwhelming that Burzynski & 3 of his patients were asked to appear on the CBS This Morning show
.
Dr. B. spoke about his antineoplaston treatment for cancer, small peptides of natural origin that he says are part of a Biochemical Defense System in the body
.
The patients presented their compelling stories
.
2 had had non-Hodgkin's lymphoma & 1 had had brain cancer
.
All claimed to be in complete, long-term remission on the treatment & spoke forcefully & eloquently about their experience
.
Ironically, in light of what was about to happen, SRB mentioned several times that he would treat free of charge patients who enrolled in his FDA-approved trials
.
Millions of people saw this show, & the response was immediate, positive, & intense
.
There were over 2,000 phone calls to the BRI that day & on subsequent days
.
Post-broadcast, everyone agreed that the CBS shows had raised public awareness of Dr. B.'s concept of cancer therapy to a new level
.
At around 2.p.m., Dr.& Mrs. Burzynski got on a plane from NY to Houston
.
15 minutes after they were in the air, the FDA obtained a Search & Seizure Warrant from US Magistrate Frances H. Stacy
.
Just past 5.p.m., after Dr. B.'s lawyer, Rick Jaffe, had left his office, the federal agents entered BRI's premises
.
Office manager Barbara Tomaszewski asked them to wait until she could contact Mr. Jaffe
.
But they told her that if she didn't allow them to search for the documents they wanted then they would do it by force
.
This time FDA refused to allow staff to take pictures of the action
.
Also, they arrived after 5.p.m.:
.
1985 - A midday raid of SRB in 1985 had led to patient outrage & the formation of a patient rights legal action fund to defend Dr. B.
.
But this time they still took a nurse away from the cancer patient she was treating
.
They then systematically began their search & seizure operation, which continued until around 11:30.p.m.
.
What did they want?
.
1983 - There is a 1983 consent decree that allows SRB to treat patients in Texas, but not to routinely ship medicines out of state
.
The main issue seemed to be the purported shipment of medicine across the Texas state line
.
We say "seems" since the charges have been sealed, & FDA representatives refuse to comment or meet with members of the Alternative Medicine Program Advisory Council (AMPAC)
.
SRB is adamant that he does not ship the medicines out-of-state without the explicit permission of FDA
.
There is a longstanding policy at BRI that any employee will be immediately terminated if he or she does so
.
Nevertheless, it is impossible to monitor the activities of every employee & every patient
.
Arriving home, Dr. B. was alerted to the raid in progress at his clinic
.
Rushing there, he found it swarming with agents going through his papers & pecking away at his computers
.
They reluctantly allowed him to make copies of the files they were taking, because otherwise he could not treat his active patients
.
3/25/1995 Friday, CBS This Morning
.
Over that weekend, The Cancer Chronicles sent out the 1st of several memos to inform members of the Alternative Medicine Program Advisory Council (AMPAC), NIH officials, Congressmen, & other interested parties of the raid
.
3/27/1995 - "Given the difficulty of delivering a letter on time," Dean Mouscher, a BRI employee commented on Compuserve,
.
"one can understand why the post office prefers to tackle something easy like brain cancer"
.
3/28/1995 - Tuesday, This Morning featured the SRB raid as its lead item, right after the regular morning news
.
3/28/1995 Monday, Rick Jaffe - Attorney, & Dr. B. were interviewed by satellite, & they gave a mature & balanced presentation of the matter
.
This Morning's host said on the air that his staff would be keeping a very close watch on developments at the SRB clinic
.
SRB has also been interviewed by & may soon appear on ABC News Nightline
.
The irony is that for several years SRB has enjoyed decent relations with the FDA in Washington
.
FDA has approved trials of antineoplastons not just at BRI but at Memorial Sloan-Kettering & the Mayo Clinic
.
Just days before the raid, the OAM's advisory council, AMPAC, held a meeting & heard a favorable presentation on Burzynski's work
.
A representative of FDA was at that meeting but there was absolutely no indication from her that FDA looked askance at BRI's conduct, or that there were violations that could not have been corrected by amicable means
.
The raid raises the disturbing possibility that someone on high wanted to wreck this relationship & make the scientific trials fail
.
The raid was a public relations fiasco for the FDA
.
So why would it shoot itself in the foot like this?
.
There are 3 theories for this turn of events:
.
The good ol' boy network
.
According to this theory, the FDA in Washington (including Commissioner David Kessler) knew nothing about the raid
.
It was engineered by a "good ol' boy" network of agents in Houston's FDA enforcement branch
.
These people are ignorant &/or contemptuous of the improved relations between the national FDA & alternative medicine, & vent their anger at what they stupidly think is the leading "quack" doctor in their midst
.
In favor of this theory: mid-level government employees did seem to be taken by surprise by the raid; we have heard that The Cancer Chronicles fax was for many their 1st word of the event
.
On the other hand, it seems equally incredible that anyone would dare to take such an action without at least Dr. Kessler's tacit support
.
Postal theory
.
According to this theory, the raid originated not with the FDA at all but with US Postal Inspectors, because of an alleged use of the mails to illegally ship antineoplastons out of state
.
A postal inspector did accompany the FDA agents on the raid
.
And 1 postal inspector allegedly told a SRB brain cancer patient that "we have better treatments for cancer" than antineoplastons!
.
Establishment theory
.
According to this view, the action had to come from the top, & is part of a long-time effort on the part of the cancer establishment, including Kessler, to "get" the innovative Texas physician
.
According to this theory, the raid was the response of quackbusters, in & out of government, who became panicked & outraged over the growing acceptance of SRB, & especially his CBS appearance
.
This theory is supported by the precision timing of the action, as well as by the fact that another FDA action in 1993 also took place while Burzynski was away, in that case at an OAM meeting attended by FDA officials
.
Whatever the final explanation, the raid on SRB was a shot across the bow of the entire alternative health movement
.
SRB patients have been contacted & harassed by FDA agents, apparently for nothing more than receiving & taking antineoplastons for their own use
.
1 cancer patient has allegedly been threatened with a Grand Jury subpoena of his own
.
In NY, FDA agents came to a patient's house & demanded that his wife turn over medicines, which she refused to do
.
But with a complete list of Dr. B.'s patients, the FDA can now contact some very sick people & their family members & attempt to generate "evidence" to be used to put their physician out of business—or worse—in prison
.
As if having cancer weren't hard enough—patients now have to deal with vigilantes masquerading as health protectors!
.
Finally, in the midst of all this legal trouble, the NCI, FDA, & Memorial Sloan-Kettering Cancer Center (MSKCC) have taken an action almost certain to scuttle clinical trials of antineoplastons at MSKCC
.
Together, they arbitrarily decided to change the terms under which Burzynski's medicines would be tested
.
Under a prior agreement with SRB, MSKCC was supposed to test antineoplastons in adults with brain tumors 5 centimeters (2 inches) or smaller, & who did not have multiple tumors
.
Yet in 2 years, MSKCC has enrolled very few patients in this trial
.
Then, without consulting Dr. B., Sloan-Kettering asked for & got permission from the FDA & NCI to test antineoplastons in patients with tumors of any size, with multiple tumors, with distant metastases, & with lower "Karnofsky" (performance) scores
.
A patient who has already failed to respond to surgery, radiation, &/or chemotherapy, who has numerous huge tumors, metastases in the liver & lungs, & a declining performance score can now be enrolled to "test" this treatment, whose protocol was designed to treat patients in earlier stages
.
It is known to all that these antineoplastons, at the dosages given, almost certainly will not work in this situation
.
Patients will die
.
Nevertheless, its "failure" will be loudly announced to the public, & will deal a heavy blow to this treatment & to alternative medicine in general
.
Some people apparently think this trick will dispose of Dr. Burzynski, leaving the field clear for any "genius" who wants to "discover" antineoplaston-like drugs
.
4 - 11/1995 - 4th Federal Grand Jury investigation
.
Every month more documents & employees are subpoenaed
.
Government uses subpoenas to intimidate & harass those who have worked with Dr. B., including journalist & author Ralph W. Moss & executives of Akzo Nobel, a huge Dutch pharmaceutical conglomerate
.
Govt. also subpoenas the medical files & patient records of Dr. Nozorodan, an independent surgeon who implants catheters for many SRB patients [3]
.
4/17/1995 - BRI's Custodian of Records was subpoenaed to testify before a Grand Jury investigating the case
.
SRB chose to boldly face his accusers, a decision which threw the federal attorneys' case off balance
.
In addition, surgeons who have been doing emergency surgery for SRB's patients have also been subpoenaed before the grand jury & ordered to bring an enormous # of documents, including medical records & details of their medical practice
.
When his patients need emergency services, such as catheter placements, they won't be able to get them
.
To add to the tension, after the raid BRI was under steady surveillance, with agents in unmarked cars recording the license plate #s of people entering & leaving the Institute
.
Put mildly, this did not foster an atmosphere conducive to the healing of cancer!
.
4/18/1995 - SRB appears before grand jury, Houston Chronical, Ruth Sorelle, Deborah Tedford, Medical Writer Staff
.
5/1995 - Former FDA Chief Counsel Peter Barton Hutt states in an article in Reason Magazine,
.
"If you beat the FDA in court, you have an angry FDA that is willing to slit your throat
.
When the FDA loses a case, it has a mind like an elephant
.
It's just something you've got to understand about the FDA
.
Once the agency makes a collective decision, trying to make it let go is almost impossible
.
These are FDA crusades -- in a real sense they are vendettas" [3]
http://reason.com/archives/1997/05/01/malignant-law-enforcement
5/1995 - Dr. Stanislaw R. Burzynski stands before a federal Grand Jury in Houston, TX, fighting for his professional life
.
He has been called to testify before this panel concerning allegations of unspecified illegal activities
.
Previous grand juries have refused insistent demands that they bring charges
.
An indictment of Dr. B. will probably mean the end of his clinic, & a devastating blow to over 200 people currently on his treatment [22]
.
6/1995 - This summer, the US government has stepped up its unrelenting attack on cancer pioneer Stanislaw R. Burzynski, MD, PhD.
.
Assistant US attorneys in Houston, Amy Lecocq & George Tallichet, continue to recklessly wield the power of the Grand Jury subpoena in what looks like an attempt to hound the SRB clinic out of business
.
6/1995 - 4 more BRI employees, Gabriella Howard, Cheryl Owens, Eva Powell, & Barbara Tomaszewski, were subpoenaed to appear before the Grand Jury 6/21/1995, making a total of 9 employees under subpoena
.
Barbara Tomaszeweski was told to bring all the medical records of 22 patients, including X rays, MRIs, CT scans, etc.
.
7/1985 - But the medical records of some of these patients were among those seized by the FDA when it raided the clinic back in 7/1985
.
1991 - 7 other sets of records were presented to the NCI in 1991
.
1992-1993 - The records of 6 patients were submitted in quadruplicate twice to the FDA in 1992 & 1993 for a Drug Master File application
.
So complying with this order was no easy thing
.
In all, there were some 800 films involved
.
Some of these cases are among Burzynski's best
.
To copy them all would have cost about $10,000.
.
6/21/1995 - At 11:05 AM, the day of the Grand Jury hearing, SRB received a phone call from his attorney, Rick Jaffe, informing him that FDA agents & a Postal Inspector would be coming to his office around 2.PM to look at the films
.
These would not be disturbed, he said
.
The agents simply wanted to make sure that they were secure
.
Instead, the agents arrived at.1 PM, while Burzynski was still searching for what they wanted, & then in a rush demanded to see the films
.
To Dr. B.'s astonishment, the FDA agents confiscated all of the films, without letting him make any copies!
.
A number of these patients are still under treatment with antineoplastons
.
How can SRB, as their physician, now know if they are making progress, since he cannot compare present to past X rays?
.
6/1995 - SRB said in late June
.
"It is clear that the intention behind this action is to disturb the treatment of patients who clearly respond to therapy & whose lives depend on us."
.
These films were in fact Dr. B's single most valuable asset for they alone provide final proof of the value of his unique antineoplastons
.
Now it will be difficult for us to publish scientific papers without having medical records,he said, ruefully
.
"And since we have been repeatedly asked to produce the same medical records, I am afraid that the records previously produced were lost & that the same fate awaits these very important films"
.
SRB now faces further rounds of investigations & demands for documents, the 4th federal Grand Jury in Houston to hound him for mountains of data
.
In addition, SRB just finished an extensive 2-year IRS audit
.
"Despite the fact that they did not find any problems in our records," he told us, "the Assistant US Attorneys are going to do the same thing all over again
.
They already subpoenaed our accountant & complete financial records"
.
The US Attorneys have also subpoenaed all patient billing records, going back to 1977
.
They have even subpoenaed the names & addresses of every person who has ever received a brochure from BRI-- which after Dr. B.'s CBS This Morning appearance numbered 2,000 per day!
.
In all, they have ordered SRB to turn over 10s of 1,000s of pages of documents
.
According to many observers, the US Attorney's office in Houston, headed by Ms. Gaynelle Griffin Jones, is acting in wild manner
.
The situation there is beginning to come to the attention of Congress
.
The law prohibits the Grand Jury from engaging in
.
"arbitrary fishing expeditions."
.
Yet what else is happening here?
.
This unending persecution conveniently allows SRB's enemies, both in & out of the FDA, to contact his scientific collaborators, & inform them truthfully that he is the
.
"target of a federal investigation"
.
This is not hyperbole
.
In fact, it is exactly what FDA did in the past, & that sparked a 1985 'Cease & Desist' order against the FDA by US District Court Judge Gabrielle McDonald"
.
It is US Attorney General Janet Reno who bears ultimate responsibility [23]
.
11/15/1995 - Oversight & Investigations Subcommittee hearings, Congressman Joe Barton
11/15/1995 - FDA Commissioner David Kessler faces harsh questioning by Congressman Joe Barton's Investigations Subcommittee about FDA's abuse of Grand Juries, & about how he can justify 4 Grand Juries with no indictment
.
Congressman Joe Barton appears to be defending Bruzynski here
.
11/15/1995 - Congressman Barton, in an attempt to intervene in “the FDA’s relentless harassment” of sick patients with a hearing in front of the Oversight & Investigations Subcommittee once again, had this to say to the FDA Commissioner:
.
“In my opinion, you have every right to use the investigative authority, & the judicial resources of the federal government to the justice department, to convene a grand jury
.
That’s very appropriate…the 1st time
.
Perhaps, even a 2nd time
.
It becomes questionable the 3rd time
.
The 4th time,
.
& the 5th time, it the 5th time, it is not, I think, an illogical conclusion to think that the FDA has a vendetta against Arthur Burzynski, or wants to retaliate for some reason
.
That’s my opinion
.
How many grand jury investigations have to occur that result in “no finding of fault” before you as commissioner of the FDA would encourage those within your organization to cease & desist?”
.
FDA Commissioner:
.
"Mr Chairman, how do you know that there were no findings of fault that were returned from that grand jury?”
.
Barton: “There have been no indictments returned”
.
Commissioner: “Mr. Chairman, I’ll ask counsel to comment, but I don’t think those are the same…as a matter of law, that those are the same things”
.
Barton: “I’m baffled by the splitting of hairs here”
.
1 week after these patients gripping testimony, 11/20/1995, Burzynski was indicted & charged with 75 counts of violating federal law
.
If convicted, would face maximum of 290 years in a federal prison, & $18,500,000 in fines
.
After a 15-year battle with the TMB's crusade to revoke Dr. Burzynski's medical license ended in defeat their own Texas State Supreme Court in 1995
.
1/1996 - Government attorneys seek a court order to stop Dr. B. from treating his patients who do not qualify for clinical trials, & calls any resulting harm to patients "irrelevant"
.
Appalled, Congressman Barton calls another hearing on FDA Abuses of Authority
.
Under pressure from Mr. Barton, Commissioner Kessler agrees to permit Dr. B. to continue treating his current patients, & to expand his current, limited clinical trials
.
2/9/1996 - US District Court Judge Sim Lake rules that Dr. B. cannot treat patients outside of clinical trials
.
Then, probably because he recognizes the harm this would cause patients, he stays his own order, so that it
tl;dr
DJT's screed appears to be plagiarized from one or more sources. I looked up a couple of links for the sources, but I guess my comment went into moderation.
My favorite part of DJT's (or somebody's) screed is this from 1990:
And yet, here we are twenty-three years later and the Japanese still haven't produced a working treatment with antineoplastons. It makes one think that perhaps, as in many other cases, small clinical trials showed promise that failed to hold up in more extensive testing.
DJT absolutely refuses to grasp that, even when his own plagiarized sources make it obvious.
Piddles, are you now, or have you ever been, in possession of a call warrant for BZYR stock?
I just can't figure out why he's posting studies and stuff that are older than my 2 adult children (or almost). Maybe in law, the older the better for a citation, but in medicine, you want the newest studies that prove your point. Medicine, like science, is self-correcting by looking at things to see if what was believed holds true or whether we can learn something new and grow with it.
And, yeah, as always, tl;dr.
Orac's blog hates links reformatting (www removed)
.
[1] commonweal. org/pubs/choices/21.html
[2] 9 Moss, The Cancer Ind., 14, 299-300
[3] snowcrest. net/wendy/Theses/FDABurzynski.htm
[4] 3rdcoa. courts. state. tx. us/opinions/htmlopinion.asp?opinionid=847
[5] http:// law. justia. com/cases/texas/third-court-of-appeals/1996/847.html
[6] http:// openjurist. org/819/f2d/1301/united-states-v-burzynski-cancer-research-institute-r
[7]
http:// law. justia. com/cases/federal/appellate-courts/F2/967/1063/464996
[8] https:// bulk. resource. org/courts. gov/c/F3/27/27.F3d.153.93-2071.html
[9] http:// ralphmoss. com/html/burz2.shtml
[10] mnwelldir. org/docs/history/biographies/burzynski.htm
[11] ralphmoss. com/burz1.html
[12] ca5.uscourts. gov/opinions%5Cpub%5C91/91-2385.0.wpd.pdf
[13] ralphmoss. com/burz3.html
[14] ralphmoss. com/burz5.html
[15] ralphmoss. com/burz8.html
[16] circare. org/pd/burzynski_932071.pdf
[17] https:// bulk. resource. org/courts. gov/c/F3/27/27.F3d.153.93-2071.html
[18] bioethicswatch. org/pd/burzynski_txorder19940831.pdf
[19] ralphmoss. com/html/burz9.shtml
[20] ralphmoss. com/burz9.html
[21] ralphmoss. com/burz10.html
[22] ralphmoss. com/burz16.html
[23] ralphmoss. com/burz17.html
[24] ralphmoss. com/burz12.html
[25] ralphmoss. com/burz13
[26] ralphmoss. com/burz13.html
Paragraphs: they are our friends. They help us make ourselves understood by people who are NOT our own brains.
Not at all.
#147 LW
.
I wouldn’t normally bother with LackWreference because of the inability to check links before replying, but the link corresponds to what's on the documentary.
http://en.wikipedia.org/w/index.php?title=Wikipedia:WikiProject_Fact_an…
#148 LackWreality
.
Marc Stephens Is Insane
"The “not enough money” argument is pretty funny."
.
It's pretty funny that anyone who "whines & cheeses" re this cites no references (links) re any information they have on SRB's financial status.
.
Have you gone on Dunn & Bradstreet:
http://dnb.alacrastore.com/storecontent/dnb2/037233459
or Hoovers:
www.hoovers.com/company-information/cs/revenue-financial.Burzynski_Clin…
to support your "whine & cheese?"
.
No???
http://en.wiktionary.org/wiki/baseless
#149 MI Dawn
.
Oh, yawn MI Dawn.
.
Being from MI, have you heard of:
http://en.m.wikipedia.org/wiki/Talk_to_the_hand
.
http://en.m.wikipedia.org/w/index.php?title=Talk_to_the_Hand:_Live_in_M…
#150 flipperrooskie
.
http://en.wikipedia.org/wiki/Speculation_(disambiguation)
#151 Nara-d-need-2-read
.
"Do you know who “OracIsGod”was?"
.
I could really care less. I referred to the name for purposes of:
http://en.m.wikipedia.org/wiki/Sarcasm
#152 LW
.
http://en.m.wikipedia.org/wiki/Conspiracy_theory
#153 flipflam
.
It wouldn't matter considering flipflam's penchant for:
http://en.wikipedia.org/wiki/Hyperbole
#162 MI Dawn
.
Let me post again for all of you who refuse to read & comprehend it.
.
I'll even post it in all CAPS.
.
" ... ANTINEOPLASTONS NEED TO BE PUBLICLY ACKNOWLEDGED BY THE FDA AND AUDITED BY CONGRESS."
Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress
http://www.burzynskimovie.com/index.php?option=com_content&view=article…
#160 LackWeyesight
.
"Japan’s enlightened universal system of health insurance pays for most of the costs of patient care for virtually all Japanese, so that the costs of observing a clinical series of patients given antineoplastons is relatively modest.
And yet, here we are twenty-three years later and the Japanese still haven’t produced a working treatment with antineoplastons. It makes one think that perhaps, as in many other cases, small clinical trials showed promise that failed to hold up in more extensive testing."
.
http://en.m.wikipedia.org/wiki/Ignorance_Is_Bliss
.
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-…
.
#23, 31, 33, 38
http://scienceblogs.com/insolence/2013/01/07/lets-make-dr-stanislaw-bur…
.
#59, 72
http://scienceblogs.com/insolence/2013/01/22/another-way-to-join-the-sk…
.
#88, 89
The Chicago Tribune is now shilling for Slippery Stan.
"Help Save Monika!"
This piece is disgusting:
http://www.chicagotribune.com/news/local/suburbs/schaumburg_hoffman_est…
And here's another recent fundraiser piece written by a clueless, gullible journalist:
http://www.leitrimobserver.ie/news/local/help-mary-fight-cancer-and-dis…
From the piece in the Irish newspaper above:
Mary said “At this time I was told it was incurable, but with treatment my life could be extended. The treatment suggested was more chemotherapy, radiotherapy and hormonal treatment.”
Mary did not accept this and she felt she could extend her life with changes to diet and lifestyle “without the horror of the side effects that remained in my consciousness all those years later.” She began a regime of juicing, raw foods, excluding dairy, meat and alcohol.
She supported this regime with meditation and alternative treatments such as acupuncture, herbal medicine and cranio-sacral therapy.
She was feeling good and started to research cancer, “I experimented with B17 infusions, chelation therapy, ozone therapy, enzyme therapy, hydrogen peroxide infusions and vitamin C infusions. I also invested in the Ondamed pulse biofeedback electromagnetic machine. All of these techniques have contributed to my outliving my doctor’s expectations.”
Although she was keeping the condition at bay, she began to experience increased lymphatic congestion and the size of the wound increased. At this point, she was drawn towards the Gene Targeted Therapy treatments available at the Burzynski clinic, despite the massive costs involved. Each treatment there is tailored for the individual patient and claims to deal with the cancer at DNA level.
After initial tests at Burzynski, Mary was told that her cancer is curable but she needs strong chemo to reduce it so the American pills can work on it...
Here's a weird irony/coincidence:
A little girl names Burzynski (father's name is Greg) with brain cancer in Wisconsin. And there's no mention of trying Stan's magic potions--they're using real medicine to treat her, it seems.
I wonder if Stan would give them a family discount if they went. I imagine all Burzynskis are related if you trace the family tree back far enough.
http://www.wqow.com/story/20576888/2013/01/13/benefit-held-for-area-5th…
I don't think that's the paper per se, but the GiveForward page is just sad. Mrs. Franz is apparently under the impression that Burzynski is "holistic." Unfortunately, I'm not turning on Platform apps to comment.
Then, probably because he recognizes the harm this would cause patients, he stays his own order, so that it
SRB files 4 new "treatment use INDs" (Investigational New Drug applications) with the FDA
.
This is to enable him to treat most patients
.
2/23/1996 - The FDA informs SRB that his request for "treatment use INDs" has been refused
.
But after pressure from Congress (especially Rep. Joe Barton, R-TX), FDA agrees to allow SRB to enroll most of his current patients in a catch-all clinical trial, "CAN-1."
.
This covers patients who began treatment before 2/23/1996
.
2/27/1996 - Lake extends his stay until noon, 3/27/1996 on condition that SRB appeals his ruling to the 5th Circuit Court of Appeals
.
SRB files his appeal
.
2/29/1996 - When the FDA & the TMB went after Dr. B. in, Sgt. Rick Schiff, an 11 year veteran of the Tampa Police Dept. testified before a US Congressional hearing
.
Dr. Burzynski has been practicing for almost 2 decades—1 of them in court fighting the FDA & the TMB
.
2/29/1996 - Sergeant Schiff
Congressional Subcommittee Hearing
.
He was defending Dr. Burzynski from a 15 year campaign by the FDA that sought to discredit & skew Dr. Burzynski’s groundbreaking work
.
Burzynski's attorney, on the CBS Morning Show shortly before his appearance at an Oversight & Investigations Subcommittee hearing
.
“Well I don’t think there’s really an issue as I mentioned regarding the safety of the drug
.
And the FDA isn’t contending at this point that the drug doesn’t work
.
The only issue is that according to the FDA that is has not been proven by controlled clinical trials
.
So at least in terms of safety the FDA is not saying that it’s not safe & the FDA isn’t even saying that it doesn’t work
.
Now they’re just contesting that, or apparently they’re contesting, whether Dr. B. himself has been shipping the medicine out of state, which in some respects is quite ridiculous since he has approval to ship the medicine out of state to various cancer institutions around the country
.
He ships it out of the country to various countries, because it’s being used in other places
.
And he ships it to individuals, who have been granted permission by the FDA to receive the medicine under what’s called “The Compassionate Use IND’s”
.
SRB won his original 10 year fight against the TMB, being found not guilty by the Texas Supreme Court
.
After a 10 year court battle that ended in the Texas Supreme Court in 1996 that resulted in a "not guilty" verdict for Dr. B. the TMB is back for another try
.
Later that day, Bruzynski’s attorney stepped in front of the Oversight & Investigations Subcommittee…
.
Richard Jaffe courageously squares off with the FDA in front of the Oversight & Investigation subcommittee
.
“So we’ve had now, 4, 5, or 6 grand juries
.
Let me talk about the subpoena practices
.
Most recently, the FDA has now subpoenaed the medical records, of every patient who has gone on TV and told their story about Dr. B.
.
We’ll let the committee judge what they think of that
.
We’ll talk about dissemination of false information by the FDA
.
2/29/1996 - SRB before another congressional hearing headed by Joe Barton
.
2/29 - 3/25/1996 - SRB, working frantically, files 60 new clinical trial protocols with the FDA
.
If approved, these would create 60 new clinical trials into which most of Dr. B's patients could be enrolled
.
Dr. B. would be able to continue treating most current & future patients
.
3/1996 - Taking advantage of the window of opportunity provided by Congressman Barton, Dr. B. files some 60 new clinical trial protocols, greatly expanding his effort to receive FDA approval [3]
.
3/12/1996 - FDA responds to SRB's request for permission to charge clinical trial patients to at least recover the cost of manufacturing antineoplastons
.
Such permission is necessary because SRB receives no outside funding
.
Janet Woodcock, MD, of FDA says that before they will consider such a request, SRB must submit detailed records of every payment ever made by his patients—more than 2,500 over the past 18 years
.
3/26/1996 - More than 20 of SRB's patients hold a press conference in Washington, DC the day before Judge Lake's order is to go into effect, cutting off 120 patients from antineoplaston treatment
.
(The FDA still has not responded to the 60 new protocols)
.
3/27/1996 - At the 11th hour, Judge Lake extends his own stay until the.5th Circuit rules on SRB's appeal
.
As a result of this "stay of execution," SRB may continue to treat his patients as before
.
3/28/1996 - FDA inspectors arrive at SRB's manufacturing facility for a "routine" inspection
.
Previously, the huge & modern facility had exceeded Current Good Manufacturing Practices standards
.
This time, inspectors claim to find several deficiencies
.
These include a failure to sample & test incoming plastic IV bags for microbiological contamination, & to maintain Certificates of Analysis from the supplier, Abbot Labs, certifying sterility of each batch received
.
SRB asks Abbot for this & Abbot replies that this documentation was already on file with the FDA;
.
they do not provide such a certificate for any of their other customers
.
FDA also attacks the pyrogen-testing procedure (pyrogens are impurities that can cause fever)
.
But the procedure SRB uses was approved by the FDA during several inspections, most recently 8/1993
.
FDA also demands testing of certain reference media
.
But again when SRB tells the supply company (Associates of Cape Cod, Inc.) of FDA's comment, it writes back:
.
"We do the standardization in-house & provide our customers with a Certificate of Analysis which is recognized & accepted by FDA"
.
Clearly, whole new standards are being created for SRB
.
3/29/1996 - FDA Commissioner Kessler appears at a White House press conference with Pres. Clinton & VP Gore to announce new, expedited approval procedures for promising cancer drugs
.
The White House & FDA Commissioner David Kessler announce sweeping changes designed to hasten the approval of new anticancer drugs, & promise expanded access to same for cancer patients
.
4/1996 - FDA inspects Dr. B's mfg. facility, & finds that testing procedures it had recently approved are now "inadequate"
.
Once again, FDA apparently tries to cut off the flow of new patients to strangle the clinic financially
.
In violation of its own rules, which requires FDA to "attempt to discuss & satisfactorily resolve the matter with the sponsor before issuing a clinical hold order"), FDA orders Dr. B. to stop accepting new patients
.
Strangely, FDA rules that the treatment is safe for current patients, but unsafe for those who have not yet begun
.
When FDA had tried to cut off current patients in the past, the result was a massive public outcry & Congressional hearings
.
Many terminally-ill patients who had come to Houston for treatment are left stranded, & deteriorate rapidly
.
4/1996 - Present - FDA constantly issues new & arbitrary conditions which create difficulties for the clinic & patients [3]
.
4/10/1996 - FDA puts all clinical trials of antineoplastons on "partial hold," citing the inspection report
.
It is "partial" since Dr. B. may continue to treat current patients, but for the 2nd time, they say he may not accept new patients
.
FDA agrees that SRB has responded to all its comments in the inspection report, but insists that the hold is necessary until a re-inspection can be performed
.
In so doing, FDA seems to violate its own rules: Code of Federal Regulations 21 CFR 312.42 subsection (c) states that FDA will attempt to
.
"discuss & satisfactorily resolve" the matter with the sponsor before issuing the clinical hold order
.
BRI spokespersons point that out there has never been an incident of contamination of antineoplastons, & in fact FDA found no trace of contamination during its inspections
.
Yet in effect FDA is telling Dr. B's patients that antineoplastons present a more "immediate & serious risk" than their own fast-growing tumors — but only if they began treatment after 4/10/1996
.
Besieged by desperate patients & their families, SRB continues to accept some new patients, but cannot put them in clinical trials — slowing the approval & widespread availability of antineoplastons
.
4/15/1996 - The 5th Circuit Court of Appeals affirms Judge Lake's order forbidding Burzynski from treating patients outside of clinical trials
.
The stay is vacated
.
Dr. B. now faces prison if he treats patients outside of the clinical trials
.
He must cut off treatment to patients who began after 4/10/1996 (the cut-off date of FDA's "partial hold") & to those who do not qualify for any clinical trial & began treatment after 2/23/1996— in all, about 20 patients
.
He will also have to turn away more than 100 very advanced cancer patients scheduled to begin treatment over the next month
.
The Burzynski clinic asks FDA's Chief of Oncology, Dr. Robert DeLap, if he would at least extend the cut-off date to 4/15/1996 so that existing patients would not be cut off
.
DeLap refuses
.
4/16/1996 - For the 1st time since opening his practice in 1977, Dr. Burzynski is forced to turn away cancer patients who have arrived at his clinic for treatment
.
Many have fast-growing tumors including glioblastoma multiforme — a brain cancer so aggressive it can double in size every 10 days
.
"These patients do not agree with FDA that the minuscule, theoretical risk of undetected pyrogens is a greater threat than their untreated cancers," says BRI's Dean Mouscher
.
"But they are powerless
.
It is difficult to describe their anguish, & that of their families."
.
4/17/1996 - In mid-April, interview Dr. Stanislaw R. Burzynski, MD, PhD, his attorney Richard Jaffe, & others involving in defending the innovative cancer doctor
.
On the day before, Dr. B. —for the 1st time in his entire career—was forced to turn away cancer patients who arrived at his clinic for treatment
.
Public inquiries about antineoplaston treatment have never been higher
.
(sometimes totalling an incredible 1,000 calls per day)
.
People are beating down the doors to get in
.
BRI is advertising on the Internet for physicians & is adding a new production line at their giant Texas plant
.
Think about this for a minute:
.
the government announces that it has indicted a doctor on 75 counts of fraud
.
Does the public run in the opposite direction?
.
Absolutely not
.
There is instead a tremendous increase in patient, public & media interest & sympathy for the physician
.
This one fact speaks volumes about what the average American thinks of the cancer-related information emanating from agencies of the US government
.
Common sense tells us that SRB is a legitimate & innovative scientist, not a fraud
.
1st, it is now well known that in 1991 NCI sent hand-picked scientists to investigate SRB's work
.
They only had time to look at 6 cases, but they concluded that antineoplastons actually caused regressions in these 6
.
2nd, SRB himself pleads for his methods to be evaluated by independent scientists
.
He came before the Office of Alternative Medicine's advisory board & offered to have OAM independently review every case coming into his office for a full year
.
He found no takers
.
3rd,, nearly a dozen top US medical centers are now investigating through clinical trials a substance called phenylacetate
.
Phenylacetate is the main ingredient in SRB's compound, antineoplaston AS2-1
.
And the erstwhile NCI scientist who developed this treatment learned about it in Texas at Dr. B's feet
.
4/25/1996 - Patient P.G., battling breast cancer that has metastasized to her brain, is admitted to the hospital
.
She arrives after the FDA hold is imposed, & has been waiting for treatment
.
In a separate action, Anthony DeCicco of the FDA's Division of Antiviral Drugs telephones Dr. B. to tell him that he must stop treating his HIV patients
.
Dr. B. reminds him in writing that this action directly violates promises by high FDA officials, including Commissioner Kessler, that FDA would not interrupt the treatment of any patient who began before 2/23/1996
.
4/29/1996 - FDA inspectors arrive at the manufacturing facility for re-inspection
.
They remain till 5/1/1996
.
5/1/1996 - The inspection finishes at.11:00.AM
.
Late that afternoon, word comes from Washington that Burzynski may once again accept new patients
.
For the patient in the hospital who is now close to death, it comes too late [25]
.
5/1/1996 - After Dr. B. responds to all FDA's comments, & under pressure from Congress, FDA lifts the clinical hold [3]
.
5/9/1996 - FDA sends a letter with "comments" on 12 more of the clinical trials Dr. B. is conducting
.
Many of the comments concern a clinical trial of rare brain tumors in children such as rhabdoid tumor of the brain, the most aggressive of all childhood cancers
.
Conventional therapy is useless against it
.
SRB is currently treating 2 children suffering from rhabdoid brain tumors
.
Dr. B. has evidence of success against this type of tumor
.
But FDA informs SRB that he must stop accepting new rhabdoid tumor patients for treatment because this tumor is so rare that
.
"it is unlikely that this trial will generate any useful scientific data"
.
And so it goes... [26]
.
10/31/1996 - NCI official Michael Friedman MD writes in an internal memo that
.
"It turns out that antineoplastons are well-defined, pure chemical moieties...
.
The human brain tumor responses are real." [3]
#161 Narad
"Piddles, are you now, or have you ever been, in possession of a call warrant for BZYR stock?"
.
NaraBZYRd
.
are you now, or have you ever been, in possession of:
http://en.wikipedia.org/wiki/History_of_the_United_States_public_debt
The answer to your moronic question is:
.
Nara-d
#164 Melissa G
.
Information in chronological order in an easily readable format is our friend.
http://en.wikipedia.org/wiki/Reading_(process)
#165 Narad
.
"Not at all."
.
No, in your case it's "Nara-d-all."
3/24/1995 - Ironically, in light of what was about to happen, SRB mentioned several times that he would treat free of charge patients who enrolled in his FDA-approved trials
.
3/12/1996 - FDA responds to SRB's request for permission to charge clinical trial patients to at least recover the cost of manufacturing antineoplastons
.
Such permission is necessary because SRB receives no outside funding
.
Janet Woodcock, MD, of FDA says that before they will consider such a request, SRB must submit detailed records of every payment ever made by his patients—more than 2,500 over the past 18 years
Stan claims he never charged anyone for clinical trials:
http://www.fox8live.com/story/20963242/dr-stanislaw-burzynski-cancer-an…
Squidymus owes me one new scroll button.
Why do I feel like I'm watching a five year old learn how to do copy and paste on a computer for the first time?
Is Squidymus seriously saying that because someone else raised money for cancer research, that means Burzyinski's antineoplastons work?
Or is it just me muddling up his incoherency into something else...?
@MSII
Of course not. Because I highly doubt anyone is actually participating in a trial.
One thing out of all the cut-and-paste non-evidence of effectiveness caught my eye:
<blockquote<ANTINEOPLASTONS NEED TO BE PUBLICLY ACKNOWLEDGED BY THE FDA AND AUDITED BY CONGRESS
What exactly does 'publicly acknowledged by the FDA" mean, DJT?
Given the lack of any clinical evidence of efficacy, you can't possibly mean they must be publicly acknowledged by the FDA as a safe and effective treatment for advanced stage cancers. So what other acknowledgement are you advocating?
Wow - 2500 clients, yet no survey of actual results from all 2500? Do we even know what he survival rates actually are?
At the TuQuack Center Waiting for my Comments to be Moderated while your Comments are Posted
Still haven't figured out that there's a length limit as well as a link limit, I see.
Here's another analysis of Stan's latest TV interview and the BS from SB. If you missed the post earlier you can watch the TV piece here as well.
http://doubtfulnews.com/2013/02/what-exactly-is-burzynski-charging-pati…
#186. FlipCan'tRead
.
#128
.
10/15/2012
.
"Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval & supervision of the FDA."
.
"The patients were treated within
.
PHASE 2 FDA CLINICAL TRIALS,
.
without the aid of the National Cancer Institute, or any other cancer research entity.”
.
"Antineoplastons are responsible for the 1st recorded cures in medical history within any FDA-approved clinical trial ..."
.
"A “cure” is defined as 5-year survival."
.
BZYR SEC Filings for BZYR Form 10-Q on 10/15/2012
.
Effective 3/1/1997
.
" ... the term of the Research Funding Agreement was renewed & extended until 2/28/2013"
.
" ... in 1997, his medical practice was expanded to include traditional cancer treatment options such as
.
chemotherapy,
.
gene targeted therapy,
.
immunotherapy &
.
hormonal 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
.
"Research & development efforts are focused on basic ANP research &
.
19 PHASE II CLINICAL TRIALS."
#128.
“In 2009,
.
PHASE II FDA-supervised CLINICAL TRIALS
.
of Antineoplastons successfully CAME TO A CLOSE."
.
#129
.
"9/29/2009 10:07:34 AM
.
" ... will provide biostatistical & data management support for BRI’s
.
ONGOING PHASE II ..."
.
#128
.
" ... as of 8/31/2012, & the results of operations comparing the 3 & 6 month periods ended 8/31/2012 & 2011"
.
" ... It should be read in conjunction with the Annual Report on Form 10-K for the year ended 2/29/2012"
.
"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"
.
"The Company is currently conducting
.
1 FDA-approved clinical trial"
.
6 Months Ended 8/31/2012 Compared to 6 Months Ended 8/31/2012
And yet, just a month ago, Brzynski was claiming over 2000 patients in just the past decade. I guess 6% doesn't sound as good as 20%. What about the other 1400 patients this past decade? What about the estimated 3,000 patients before that?
I wonder if the answer to that and other questions brought up by doubtfulnews are accounted for by this:
We know from The OTHER Burzynski Patient Group and the descriptions of his trial protocols on clinicaltrials.gov that the antineoplastons are normally delivered by IV. It appears that the oral form of PB is only given when a patient doesn't qualify for the clinical trials. "We weren't charging for clinical trials of the pill therapy (because there weren't any!)"
Interesting development.
And what's SB's BS about trials in China? Did Dr. Pants-On-Fire pull this out of his ass? It's the first time ever that China has been mentioned.
#187 JustGaveupComprehending
.
"One thing out of all the cut-and-paste non-evidence of effectiveness caught my eye:
.
ANTINEOPLASTONS NEED TO BE PUBLICLY ACKNOWLEDGED BY THE FDA AND AUDITED BY CONGRESS
.
What exactly does ‘publicly acknowledged by the FDA” mean, DJT?
.
So what other acknowledgement are you advocating?"
.
http://i.word.com/idictionary/publicly
#128
.
10/15/2012
.
"Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval & supervision of the FDA."
.
"The patients were treated within
.
PHASE 2 FDA CLINICAL TRIALS,
.
without the aid of the National Cancer Institute, or any other cancer research entity.”
.
"Antineoplastons are responsible for the 1st recorded cures in medical history within any FDA-approved clinical trial ..."
.
"A “cure” is defined as 5-year survival."
.
BZYR SEC Filings for BZYR Form 10-Q on 10/15/2012
.
#181
.
10/31/1996 – NCI official Michael Friedman MD writes in an internal memo that
.
“It turns out that antineoplastons are well-defined, pure chemical moieties…
.
The human brain tumor responses are real.” [3]
#188 Lawrence not of Arabia
.
Hmmm ... Do you think a Congressional AUDIT might provide the answer to your questions?
The report actually says "we," which I find somewhat interesting in that skimming the 10-K led me to the impression that Scamley has something of an arm's-length arrangement with BRI. I need to go find an actual PDF.
#189 Narad
.
"Still haven’t figured out that there’s a length limit as well as a link limit, I see."
.
Nara-D-Minus-in-Math
.
#77
.
Did you notice the 40 links provided in this post, yet the above was only 26???
.
OH WAIT!! THAT means you would actually do some research before you blatherskited!!!
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
#193 MarcSIICKNESSself-evident
.
It's "self-evident" that you do not pay attention, otherwise you would already know this from the below posts:
http://en.m.wikipedia.org/wiki/Self-evidence
#160 LackWeyesight
.
“Japan’s enlightened universal system of health insurance pays for most of the costs of patient care for virtually all Japanese, so that the costs of observing a clinical series of patients given antineoplastons is relatively modest.
And yet, here we are twenty-three years later and the Japanese still haven’t produced a working treatment with antineoplastons. It makes one think that perhaps, as in many other cases, small clinical trials showed promise that failed to hold up in more extensive testing.”
.
http://en.m.wikipedia.org/wiki/Ignorance_Is_Bliss
.
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-…
.
#23, 31, 33, 38
http://scienceblogs.com/insolence/2013/01/07/lets-make-dr-stanislaw-bur…
.
#59, 72
http://scienceblogs.com/insolence/2013/01/22/another-way-to-join-the-sk…
.
#88, 89
Wait, did Didums just demand that Dr. B should release all of his results for scrutiny?
#188, Lawrence, February 5, 2013:
Burzynski is carefully hiding the data. What we do know is that he paraded the best seven of his case files before a review board. Of these, only five had survived his treatment. By the simple observation that survival is better than non-survival, we know that there were no other survivors. By that time, his total cases were approximately 3500. (I may have the numbers off a little, but it's the right order of magnitude.)
We can't know how many of his five survivors came from the 2500-patient subset and how many from the later 1000, but it doesn't really matter.
DJT played some (pretend arithmetic) number games and claimed that 5 survivors out of 3500 cases yielded a survival rate of 80%. That's why nobody pays attention to DJT, and why he's reduced himself to preschool-style name-calling and random, repetitive copy-pasta.
I'm not having trouble with the meaning of the word 'publicly' DJT. I'm asking you to explain what exactly is being asked --what action on the part of the FDA--as public acknowledgment.
Again: you can't possibly mean an FDA admission that they're an effective treatments for advanced cancer, can you?
One more question--what exactly do you expect congress to audit? Burzynski hasn't published results from any of the 60-plus clinical trials he's supposedly been conducting for the past few decades--what's to review?
Something something JaG-Coff random Wikipedia link something.
#97 - 98 LoW on "fact-checking"
.
"This seems to have expired seven years ago. I guess Burzynski missed his chance and Big Pharma jumped in to steal his discovery … oh, wait."
.
You were saying???
.
" ... Burzynski was more concerned with protecting his patents ..."
.
"I did not consider at all the problem of patent protection versus filing of an IND
.
1st of all, the patent application was filed already, &, on the other hand, I did not have any reservation in sharing the details of production & treatment with Antineoplastons with any researcher all over the world
.
For instance, I gave the procedure on how to synthesize Antineoplaston A10 to the People's Republic of China, where I do not have any patent protection
.
In the future, the People's Republic of China could be a huge market for pharmaceuticals, ...
.
As a result of such sharing of technology, the doctors in China were able to synthesize Antineoplaston A10 a few years ago & are using their product successfully in their research"
www.commonweal.org/pubs/choices/21.html
#199 Lawrench
.
"Wait, did Didums just demand that Dr. B should release all of his results for scrutiny?"
.
NO. I actually did something called "fact-checking" & research. & posted the results & provided the link.
.
Maybe YOU should try accessing the link & read the information!
.
#173
http://www.burzynskimovie.com/index.php?option=com_content&view=article…
#200 Bill Price
.
"DJT played some (pretend arithmetic) number games and claimed that 5 survivors out of 3500 cases yielded a survival rate of 80%. That’s why nobody pays attention to DJT, and why he’s reduced himself to preschool-style name-calling and random, repetitive copy-pasta."
.
#130 Didymus Judas Thomas
.
#124. LW
.
“For those who may have missed it,”
.
Is THAT the best you can do???
.http://www.unlimitedchoice.org/blog/humour/a-guide-to-truth-and-bullshit
You don’t seem to be able to comprehend the concept of “turn-about is fair play."
.
You post BS, I call BS & post it back in return.
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
See post #205 above.
#201 JGC
.
"Again: you can’t possibly mean an FDA admission that they’re an effective treatments for advanced cancer, can you?"
.
JGC, please let me know what part of the English language you do NOT understand.
.
#128
.
10/15/2012
.
“Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval &
.
SUPERVISION OF THE FDA.”
.
“The patients were treated within
.
PHASE 2 FDA CLINICAL TRIALS,
.
without the aid of the National Cancer Institute, or any other cancer research entity.”
.
“Antineoplastons are responsible for the 1st recorded cures in medical history within any
.
FDA-approved CLINICAL TRIAL …”
.
“A “cure” is defined as 5-year survival.”
.
BZYR SEC Filings for BZYR Form 10-Q on 10/15/2012
.
If patients were treated with Antineoplaston treatment in the USA, underthe
.
SUPERVISION OF THE FDA
.
within
.
PHASE 2 FDA-APPROVED CLINICAL TRIALS,
.
where
.
“A “CURE” is defined as 5-YEAR SURVIVAL,"
.
then the FDA should PUBLICALLY ACKNOWLEDGE it,
.
unless they are going to use some "whine & cheese" excuse like:
.
1. It wasn't under SUPERVISION OF THE FDA, or
.
2. It wasn't a PHASE 2 FDA-APPROVED CLINICAL TRIAL, or
.
3. We've changed the definition of “A “CURE” defined as 5-YEAR SURVIVAL.
#202 JGC
.
"One more question–what exactly do you expect congress to audit?"
.
JGC, for all the "whining & cheesing on this blogsplat, I still haven't seen any blatherskiter cite any law or regulation that says SRB has to release any information to you.
.
Maybe you should send a Freedom of Information Act (FOIA) request to the FDA for any data provided to them by SRB.
.
In the meantime, you might actually attempt accessing the link I provided unless you're "skeered."
.
#173
http://www.burzynskimovie.com/index.php?option=com_content&view=article…
@Squidymus
I can read, I just can't comprehend what you're saying. That and I don't have time to fully trawl your screeds (where do I send the bill for my scroll button?) The problem is with you and your language issues, not mine.
You've shown you can write normal sentences and respond in a normal way, why do you refuse to do it at all times? Stop resorting to childish wordplay and start acting like a grown up. Maybe then we'd take you seriously and stop laughing at your inanities; we might even agree with you if you'd just state what it is you're on about.
Also, one does not need citations when pointing out logical errors or basic primary-school math. Maybe you should figure out what a citation actually means. And try reading the ones you do cite.
@Narad
All the better to throw doctors under buses one would think.
@Lawrence
I do believe somewhere in there is a thought process that we're not allowed to criticise Burzyinski without first giving false balance and waiting until after B publishes. Not that he'd admit it outright, as I've tried to corner him on it a couple of times (see my comments about defending B ) and he refuses to answer legibly.
#203. Narad
.
"Something something JaG-Coff random Wikipedia link something."
.
I see you couldn't even provide a citation or reference for THAT!!! ;)
@flip - the endless word salad is quite droll at this point & Didums has yet to articulate a well-thought out position (you know, a couple of normal paragraphs).
How fascinating. So there was never in all of recorded history a cure (of what? anything?) before the FDA was established and started approving clinical trials.
That certainly puts paid to the claims of all those naturopaths who claim that herbs have been used to cure diseases since time immemorial.
Oh, and all you researchers outside the US? Might as well pack it in. Without FDA approval you're pretty much out of luck.
I shouldn't comment early in the morning. I read "within" as "without". Apologies to all, even DJT. I'll shut up and get some coffee onw.
@Lawrence
Actually I have caught a couple of sentences that were properly structured and made sense. They are rare and so one can easily miss them amongst his scroll-of-posts and regular idiocy. Which isn't to say my guesses on what he is trying to say are valid.
I really shouldn't engage with the twat, but I'm sick of seeing the endless tracts on every thread about Burzyinski.
#209 flip
.
@Squidymus
.
#186. FlipCan’tRead
.
" I just can’t comprehend what you’re saying."
.
Yet I as supposed to comprehend what you're saying!
http://en.wikipedia.org/wiki/Reading_comprehension
"That and I don’t have time to fully trawl your screeds (where do I send the bill for my scroll button?)"
.
Yet I make time to fully read all of y'all's manifestos (where do I send the bill for my corrective LASIK surgery?)
.
"The problem is with you and your language issues, not mine."
.
The problem is with y'all's excuses & "whine & cheese" issues, not mine.
.
"You’ve shown you can write normal sentences and respond in a normal way, why do you refuse to do it at all times?"
.
Because y'all make excuses for not accessing links & reading the content & making me re-post what has already been posted before.
.
"Stop resorting to childish wordplay and start acting like a grown up."
.
Stop resorting to childish excuses unless you're going to be like Bill Price & admit you didn't read everything.
.
#200 Bill Price
"At the keyboard, hoping that the braindead lack of preview doesn't bite me"
.
"Maybe then we’d take you seriously and stop laughing at your inanities; we might even agree with you if you’d just state what it is you’re on about.
.
Maybe then I'd take y'all seriously & stop laughing at your blatherskites; I might even agree with y'all if y'all would just state what it is you're on about; because who can understand this?
.
#28
" ... I’ve clearly posted items not exactly complimentary to SRB on here, but I find it more fun to question the tu-quacking tu quoque quoting posters."
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-m…
"Also, one does not need citations when pointing out logical errors or basic primary-school math."
.
Posting BS & calling it BaSic logic & claiming basic primary school math when y'all didn't read the citations; so y'all's "basic primary school math" is based on "logical errors," doesn't cut the cheese, it just smells like the cheese whiz.
.
"Maybe you should figure out what a citation actually means."
.
Maybe y'all should figure out how to actually access a citation & read it until you comprehend it.
.
"And try reading the ones you do cite."
.
And try reading the ones I do cite.
#211 Lawrence
.
"[T]he endless word salad is quite droll at this point & Didums has yet to articulate a well-thought out position (you know, a couple of normal paragraphs)."
.
really? Really?? REALLY???
.
excuses! Excuses!! EXCUSES!!!
.
whine & cheese. Whine & Cheese. WHINE & CHEESE.
.
I like how my post #204 & after we're "awaiting moderation," but y'all's #209 & after comments were already posted.
#214 flip
.
"I really shouldn’t engage with the twat, but I’m sick of seeing the endless tracts on every thread about Burzyinski."
.
I KNOW!! Because its NOT like y'all actually know what you're posting about because you've researched & "fact-checked" it, now is it???
.
Post #204
.
Maybe you SHOULD stick to TWATTING!!! ;)
#212 LW
.
“Antineoplastons are responsible for the 1st recorded cures in medical history within any FDA-approved clinical trial …”
"How fascinating. So there was never in all of recorded history a cure (of what? anything?) before the FDA was established and started approving clinical trials."
.
Oh might Grand Wizard & Lord of the Wrings
.
I take it that because of your pride in "attention to detail" & self-respect for yourself, that you noted the reference to above post #128:
.
"Antineoplastons are responsible for the 1st recorded cures in medical history within any FDA-approved clinical trial ...
.
for INOPERABLE BRAINSTEM GLIOMAS IN CHILDREN-WITH 30%-50% CURE RATE.
I just read some exciting, breaking news on the Josephine Jones website. No details yet, but she's reporting that the FDA has forced Slimy Stan to stop accepting new patients for ANPs!!!
More news later Thursday. I'm sure Orac and JJ will be all over this as more details come in.
@MSII - if that's the case, that is great news! It would explain why ANPs had disappeared from his website.....looks like the gravy train might be coming to an end for old Stan, hopefully.
Nah, he'll just move to Mexico and set up between Hulda Clark's operation and the laetrile crooks.
Keep your eyes on Josephine Jones's and medtek's twitter feeds. They seem to be on top of this.
Yup, it seems like it's happening!! Keir Liddle is a guest columnist on Josephine Jones's site and has a post today about an FDA audit at Scummy Stan's clinic that's been in progress for the past month. He has excerpts from a Burzynski patient's blog which has some details,
http://josephinejones.wordpress.com/
Sorry, here's the correct link:
http://josephinejones.wordpress.com/2013/02/07/burzynski-killing-withou…
From a patient's own blog (it's on CaringBridge but is private):
The FDA stopped new pediatric patients because a child had went (sic) into a tumor related coma and did not get enough water during treatment, thus spiking the sodium level to a fatal level..
No bloody side effects, huh?
And the FDA audit has permission to be extended another month, so BS-SB will definitely be taking a hit in the pocketbook if he can't enroll new customers for another four weeks!
medtek is saying the ANP ban also applies to new adult patients. Speculation the FDA waited for the audit to see what the TMB outcome would be. (I guess if the TMB shut him down the FDA wouldn't need to step in).
Might be fun to monitor man-whore Merola's twitter feed to see how he flips out over this. Might scuttle the release of his second commercial.
Fantastic news - thanks MSII for the info!
A certain troll (or Burzyinski defenders) in 5... 4... 3... 2... 1...
Oh geez, I can imagine the new movie now: Burzyinski under fire as he takes on yet more harassment from the evil bad gubberment - cue shots of his lawyers - "it wasn't me your honour, it was the nurse who didn't let the patient get the water" - cue shot of B with a halo around his head. Like Wakefield, I expect this will be the time to double-down on the marketing/bulldust.
DJT,
That's a quote from Burzynski's movie, not from any peer-reviewed paper, and it isn't true. No properly controlled trials of antineoplastons for gliomas have ever been published, so it is not possible to say with any degree of certainty that antineoplastons are responsible for anything of the sort.
Can you name a single Burzynski patient with a biopsy-diagnosed inoperable brainstem glioma who has survived for more than 5 years without any conventional treatment? Every case I have looked at closely either had a doubtful diagnosis, or was treated with surgery and/or radiotherapy and could be a case of artifactual tumor progression or regression after conventional treatment leading to the appearance of a response to antineoplastons.
That's why Burzynski needs to complete a Phase III study if he is going to demonstrate any real efficacy of antineoplastons. Many of us strongly suspect that he hasn't done so because they are not effective, not because of a lack of either funding or suitable patients as you have suggested.
I really hope in all this someone at the FDA is reading the various blogs and comments about Burzyinski. The wealth of information out there already is worth them looking into.
#229 Krebiozen
.
DJT,
.
"That’s a quote from Burzynski’s movie, not from any peer-reviewed paper, and it isn’t true."
.
NO, KreBloggerZen.
.
This is from post #218, which is in reference to #207, re: #194, re #191, re #128
www.sec.gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex9…
.
http://biz.yahoo.com/e/121015/bzyr10-q.html
Specifically, the 2nd link.
.
This is why I have a difficult time taking a lot of you "SERIOUSLY," because of this apparent lack of researching & "fact-checking" before posting.
I hope, while the FDA is auditing him, that they finally cancel or revoke the never-gonna-happen Phase III trial approval and make it official.
IT"S OVER FOR STAN!!!!
Here's more from the patient's blog:
I believe it was August, the FDA stopped new pediatric patients because a child had went into a tumor related coma and did not get enough water during treatment, thus spiking the sodium level to a fatal level. Now, in January, for reasons unknown to me, the FDA has suspended new adult patients from the ANP as well. I do not know when the new patients will be allowed again or if any restrictions on current patients will also follow. Friday, the Burzynski Clinic shipped us 3 months of ANP, where they normally only ship 2 weeks. They are being proactive and making sure we have the meds she needs just in case any medicine production is stopped. Apparently, a person who monitors the medicine production had a serious medical emergency. This, along with the FDA auditing has us a little on edge waiting to see how it all plays out. Even though this is bad news for the clinic, there is silver lining because when this is finished, the clinic should be moving into Phase 3 of the clinical trail and hospitals and doctors should be able to start prescribing the ANP and doing clinical trials of their own. To my knowledge, Dr. Burzynski has the only medicine not sponsored or picked up by a pharma company. I think that’s why things don’t work like they do for normal drug approval.
I see his customers are still being lied to and deluded about the "never-gonna-happen" Phase III trial.
http://skepticalhumanities.com/2013/02/07/something-is-going-down-at-th…
Of course the Burzynski suck-ups on Twitter are saying this isn't credible, we're all lying, that we're ignoring all the people "cured" and that Stan is saving lives.
A certain troll (or Burzyinski defenders) in 5… 4… 3… 2… 1…
:)
I was able to find the above quote in Burzynski's movie. I was not able to find it at either of the links DJT provided.
What was that about fact-checking?
@W - this is actually the quote I like best:
Certain matters discussed in this quarterly report, except for historical information contained herein, may constitute "forward-looking statements" that are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking statements provide current expectations of future events based on certain assumptions. These statements encompass information that does not directly relate to any historical or current fact and often may be identified with words such as "anticipates," "believes," "expects," "estimates," "intends," "plans," "projects" and other similar expressions. Management's expectations and assumptions regarding Company operations and other future results are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the anticipated results or other expectations expressed in the forward-looking statements.
If old Stan ever put a quote like that in an SEC filing, he could easily be held liable (since he, most likely, has to sign off on the accuracy of everything in the filing, or be held criminally responsible) - so I'm not surprised that those links don't say what Didums say they do....or that anyone would use SEC filing as a measure of Scientific justification for anything.
So, DJT, has Jimmy Wales sent you a bouquet of roses and a comically oversized golden key to the City of Wikipedia yet?
It's rather amusing that even DJT is unable to parse DJT.
DJT,
Where are the published results of a controlled study or studies that show that antineoplastons are "responsible for the first recorded cures in medical history within any FDA-approved clinical trial for inoperable brainstem gliomas in children -- with a 30%-50% cure rate"? What is the evidence for this claim?
“forward-looking statements” that are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
That is classic. "Nothing in this report should be read as non-fiction".
Also perhaps worth mentioning is that long-term survival of children with brainstem glioma is rare but not unknown.
Except the historical statements. This is standard financial boilerplate.
Narad,
Jimmy Wales doesn't seem to have much tolerance for any form of quackery. He's become outspoken against homeopathy (someone tried to sell him Oscillo and he declared it utter nonsense) and is using WP to fight homeoquackery. I'm glad he's such a staunch opponent of medical quackery like BS-SB as well.
Narad,
Here's a short essay Jimmy Wales wrote about his intention to try to bring down homeopathy. I like this guy!
http://jimmywales.quora.com/Homeopathy-Oscillococcinum-in-particular
When people are told that Oscillococcinum can disrupt the DNA of the flu, they may very well choose not to have a flu vaccine.
What I want to know is this: why is this legal? Or, if it is not legal, then what can be done about it? I'm quite sure that the clerk himself had no direct financial interest in defrauding me, and likely didn't even know he was doing it.
In the Guardian article, "Take-up of flu jab drops" it was reported that the percentage of high-risk elderly people in the UK receiving the vaccine was just under 50%. How many of the other 50% chose not to take it because they believe this hoax remedy will protect them? And how many of those died?
My understanding is that the legal situation in the UK is particularly bad. Homeopathic remedies of no value whatsoever are legally marketed as cures for specific diseases.
Who should I talk to about this in order to encourage the creation of a campaign to stop this? This is not my primary area of interest and so I am not the right person to lead it myself. But I would like to help.
#219 Marc Stephens Is Insane
.
"I just read some exciting, breaking news on the Josephine Jones website. No details yet, but she’s reporting that the FDA has forced Slimy Stan to stop accepting new patients for ANPs!!!"
.
Is this the same FDA???
.
This current FDA official read from a former FDA agent's letter to a Congressman stating that:
.
"Dr. Burzynski may manufacture & sell antineoplastons in Texas, where the FDA lacks jurisdiction"
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
Post #154
#224 Marc Stephens Is Insane
.
"No bloody side effects, huh?"
.
Oh!!! THESE "side effects" I've posted about before???
www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/…
" ... informed consent forms that all patients were required to sign
.
In these forms, Dr. B. clearly informed the patients that his antineoplastons were experimental in nature & had not been approved by the FDA
.
The forms were explicit that there could be no guarantee that antineoplastons would reduce or stabilize their cancers
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
Post #154
.
Do you think the patient signed one of these???
.
WHO didn't make sure the patient stayed hydrated???
I have been chewing on rumors that Burzynski is establishing his anti-aging business in various countries abroad, but not ANP for cancer (except perhaps Japan). Is it possible he is setting himself up for greener pastures?
Didymus Judas Thomas, I suspect, will be very interested in tomorrow's post. Yes, it is about Stanislaw Burzynski. Stay tuned. :-)
#238 Narad
.
"So, DJT, has Jimmy Wales sent you a bouquet of roses and a comically oversized golden key to the City of Wikipedia yet?"
.
You do know JW is from Alabama, right??
.
And you DID "fact-check;" as you ALWAYS do before you post, right???
.
How can I contact Jimmy Wales directly? - Quora
www.quora.com
"You can email me ... Keep in mind that I get a lot of email, so I am often slow in responding."
Orac,
Without asking for spoilers, does tomorrow's post concern the FDA audit?
#249. Orac
.
"Didymus Judas Thomas, I suspect, will be very interested in tomorrow’s post. Yes, it is about Stanislaw Burzynski. Stay tuned."
.
Hopefully it will be about "Fact-Based Medicine." ;)
Be patient Marc. I'm sure Orac will be serving up a delightful scrumptious post about Stan.
I hope he posts it around 3 am ET like he sometime does. I'm still awake then and can read it before I go to sleep.
The tweets from #BurzynskiSaves about this FDA audit are getting nastier and nastier, if anyone cares to follow him/her/it (it's probably Mercola anyway.)
Damn...that should have been Merola. Why do those two twits have to have such similar last names?
#229 Krebiozen
.
DJT,
.
That’s a quote from Burzynski’s movie, not from any peer-reviewed paper, and it isn’t true. No properly controlled trials of antineoplastons for gliomas have ever been published, so it is not possible to say with any degree of certainty that antineoplastons are responsible for anything of the sort."
.
Based on your "word salad," I'm going to dissect it leaf by leaf.
.
Post #128
.
Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval & supervision of the FDA.
.
The patients were treated within “Phase 2 FDA clinical trials”, without the aid of the National Cancer Institute, or any other cancer research entity.”
.
ANTINEOPLASTONS ARE RESPONSIBLE FOR THE 1ST RECORDED CURES IN MEDICAL HISTORY WITHIN ANY FDA-APPROVED CLINICAL TRIAL FOR INOPERABLE BRAINSTEM GLUOMAD IN CHILDREN-WITH A 30%-50% CURE RATE.
.
A “cure” is defined as 5-year survival.
.
1/13/2009 - Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic BRAINSTEM GLIOMA
www.sec.gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex9…
“... a type of tumor that has shown itself to be highly treatment resistant
.
& challenged further by severely limited treatment options."
.
"... overall survival of children with newly-diagnosed diffuse intrinsic BRAINSTEM GLIOMA (DBSG) who receive ... antineoplaston therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)]"
.
"DBSG are considered to be one of the most difficult types of cancer to treat."
.
"It combines highly malignant characteristics with the very difficult location of the brainstem."
.
"DBSG are inoperable because they involve most of the brainstem (diffuse and intrinsic)."
.
"The # of children in the US with BRAINSTEM GLIOMAS is approximately 660."
.
"Absent treatment, the survival rate from time of diagnosis is 6 months or less."
.
"At present, there are no standard curative treatments for the disease."
.
RT is the only treatment that may slow its progress:
At 2 years 93% of children with this type of cancer die.
None of them survive for 5 years.
.
"Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective."
.
"There are no pharmacological treatments approved for DBSG at this time."
.
Based on data provided by SRB, I take it the FDA approved the above, based on the below:
.
5/1/2012 - Certain prospective protocols which have reached a Milestone:
.
· Protocol BT-06, involving the study of A10 & AS2-1 in children with high grade glioma
· Protocol BT-07, involving the study of A10 & AS2-1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy
· Protocol BT-09, involving the study of A10 & AS2-1 in patients with brain tumors
· Protocol BT-10, involving the study of A10 & AS2-1 in children with brain tumors
· Protocol BT-11, involving the study of A10 & AS2-1 in patients with brainstem glioma
· Protocol BT-18, involving a study of A10 & AS2-1 in the treatment of “mixed glioma,” a type of PMBT
· Protocol BT-20, involving the study of A10 & AS2-1 in patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy
· Protocol BT-22, involving a study of A10 & AS2-1 in children with primary malignant brain tumors
5/1/2012 - The results of Protocols BT-06, BT-07, BT-09, BT-10, BT-11, BT-12, BT-18, BT-20, BT-22 are set forth below:
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-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-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-22 / 40 / 24 / 1 / 4.2% / 3 / 12.5% / 9 / 37.5% / 11 / 45.8%
.
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 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 classified as complete & partial responses
4 obtained stabilization
4 developed progression of disease
.
Notwithstanding the response results of the trials that have reached a Milestone, FDA may require additional clinical trials based upon such protocols to be conducted by an institution not affiliated with Burzynski before advising that an NDA filing is warranted
.
FDA has indicated it will not accept efficacy data, but will accept toxicity data generated by the Phase II study according to Protocol CAN-1 because the trial was partially retrospective
.
The Company cannot predict if &/or when it will submit an NDA to the FDA, nor estimate the # or type of additional trials the FDA may require
.
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
.
5/1/2012 - 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 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
.
Title of Protocol / Subject of Protocol / # of Persons Enrolled
BT-10 / Children with Brain Tumors / 30
.
Orphan Drug Designation
.
10/30/2008 - FDA granted ODD for A10 & AS2-1 for treatment of GLIOMAS
.
9/3/2004 - FDA granted ODD for A10 & AS2-1 for treatment for patients with BRAIN STEM GLIOMA
.
2/23/1996 - FDA requested all then-current patients desiring to continue Antineoplaston treatment be admitted to a Phase II Study, according to Protocol CAN-1
.
This 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 one of the other studies sponsored by the Company, as appropriate
.
All clinical trials are for the treatment of a wide variety of cancers using only a combination of A10 & AS2-1
.
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
.
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 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
.
1994 - Phase II Clinical Trials
.
Began Phase II clinical studies with 4 studies
.
A # of patients were also receiving Antineoplastons outside clinical trials
.
1983 - Orphan Drug Act, 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 1st 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 7 years 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
www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110…
.
3/2006 - Targeted therapy with antineoplastons A10 & AS2-1 of high-grade, recurrent, & progressive BRAINSTEM GLIOMA
www.ncbi.nlm.nih.gov/m/pubmed/16484713
Brainstem glioma carries the 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 is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
.
Objective of report is to summarize the outcome of patients with HBSG treated with antineoplastons in 4 phase 2 trials
.
18 evaluable:
4 - glioblastomas
14 - anaplastic HBSG
.
14 - diffuse intrinsic tumors
12 - suffered from recurrence
6 - didn't have radiation therapy or chemotherapy
.
Overall survival at 2 & 5 years:
39% & 22%, respectively
.
17+ years: maximum survival for patient with anaplastic astrocytoma
5+ years: patient with glioblastoma
.
At 6 months:
39% Progression-free survival
.
11% - Complete response achieved
11% - partial response
39% - stable disease
39% - progressive disease
.
Antineoplastons were tolerated very well:
1 case - grade 4 toxicity (reversible anemia)
.
Antineoplastons contributed to 5-year + survival in recurrent diffuse intrinsic GLIOBLASTOMAS & anaplastic astrocytomas of the BRAINSTEM in a small group of patients
http://m.ict.sagepub.com/content/5/1/40.short
.
http://m.ict.sagepub.com/content/5/1/40.abstract?maxtoshow=&HITS=10&hit…
.
http://ict.sagepub.com/content/5/1/40.abstract
PDF
http://antineoplaston.us/yahoo_site_admin/assets/docs/Targeted_Therapy_…
.
http://assets0.pubget.com/paper/16484713/Targeted_therapy_with_antineop…
2003 - Phase II study of antineoplaston A10 & AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: a preliminary report
www.ncbi.nlm.nih.gov/m/pubmed/12718563
1st 12 patients admitted to the study
10 evaluable patients:
2 complete response (20%)
3 partial response (30%)
3 stable disease (30%)
2 progressive disease (20%)
.
Survival at 2 years was 33.3%
.
Of all 12 patients:
2 - (17%) alive & tumour free for over 5 years since initial diagnosis
1 - alive for 5+ years
1 - alive for 4+ years from the start of treatment
.
Only mild & moderate toxicities were observed, which included:
3 - cases of skin allergy
2 - cases of anaemia, fever & hypernatraemia
1 - single case of agranulocytosis, hypoglycaemia, numbness, tiredness, myalgia & vomiting
.
Results compared favourably with responses of radiation therapy & chemotherapy
.
Study continues with accrual of additional patients
http://mobile.adisonline.com/drugsrd/_layouts/oaks.journals.mobile/abst…
http://adisonline.com/drugsrd/pages/articleviewer.aspx?mobile=0&year=20…
www.ingentaconnect.com/content/adis/rdd/2003/00000004/00000002/art00002
http://assets0.pubget.com/paper/12718563/Phase_II_study_of_antineoplast…
#229 Krebiozen
.
"Can you name a single Burzynski patient with a biopsy-diagnosed inoperable brainstem glioma who has survived for more than 5 years without any conventional treatment?"
.
Oh, yeah!! Let me just grab my crystal 8 ball!!! ;)
.
After all there's nothing like patient confidentiality...
.
I would know names like you would know names.
#229 Krebiozen
.
"Every case I have looked at closely either had a doubtful diagnosis, or was treated with surgery and/or radiotherapy and could be a case of artifactual tumor progression or regression after conventional treatment leading to the appearance of a response to antineoplastons."
.
I guess I can now "officially" ignore those studies that mention patients treated without radiation or chemo.!!!
Squidymus blathers
Yeah, cause it's not like those patients aren't revealing all their confidential treatment info all over Facebook and fundraising sites and blogs. How dare we ask for info they're publishing freely themselves in public places?
#229 Krebiozen
.
Some of the cancer medicines recently given "accelerated approval" by the FDA:
.
2010 - Afinitor (ubependymal giant cell astrocytoma (SEGA) brain tumor)
.
FDA granted accelerated approval for Afinitor after a single Phase 2 study of only 28 patients
.
32% of patients experienced a 50% reduction of their tumor, NONE of their tumors went away completely
www. novartis. com/newsroom/media-releases/en/2010/1457419.shtml
2009 - Avastin (Glioblastoma brain cancer)
www. drugs. com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
FDA granted accelerated approval for this medicine for Glioblastoma
.
FDA’s reasoning:
.
“People with this type of brain cancer have had no new treatments in more than a decade”
.
What about “brainstem glioma” patients?
.
They haven’t had a new treatment for that condition—ever
.
Only 58 patients were treated in a single Phase 2 study
.
The median “response duration” was a mere 3.9 months
.
That is a “response”, not a cure, or even any real extension of life at all
.
Antineoplastons have a 30% cure rate in "brainstem glioma", not a “response rate”
.
During this single Phase 2 arm of 58 patients that got Avastin accelerated approval for Glioblastoma—NONE of them were cured
.
Avastin is a gene-targeted therapy, which can only target certain specific genes
.
Antineoplastons have an upward of a 9% cure rate for this condition
.
Most of the public could care less about “response rates”—they want to see actual cures
.
But, if “response rates” are important, how about the total of 368 patients treated with antineoplastons in Phase 2 trials for Glioblastoma where 40.5% of them had a stable disease?
.
That is of course if we care about “response” vs. “cure”
.
2008 - Avastin (breast cancer)
www. drugs. com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
FDA granted accelerated approval for Avastin in the treatment of advanced breast cancer
.
The results that allowed it to be “accelerated”
.
Only 11.3 months of “Progression-free survival”
.
FDA took it off the market for this condition 11/2011 because it doesn’t work at all if not properly prescribed
www. fda. gov/NewsEvents/Newsroom/ucm279485.htm
The company that owns it made their fortune from it already for this condition, making up for 17% of the entire company's sales
www. wikinvest. com/stock/Roche_Pharmaceuticals_(RHHBY)
1999 - Temodar (Anaplastic Astrocytoma brain cancer)
www. drugs. com/temodar.html
FDA granted accelerated approval for Temodar for Anaplastic Astrocytoma brain cancer
.
Only 12 of 54 patients “responded”, with only 9% of them being “cured”
http:// clincancerres. aacrjournals. org/content/11/19/6767.full
Antineoplastons have a 25% cure rate for this condition
.
2/2008 - Treatment of children with diffuse intrinsic brain stem glioma with radiotherapy, vincristine and oral VP-16: a Children's Oncology Group phase II study
www.ncbi.nlm.nih.gov/pubmed/17278121
Prognosis for children with brain stem glioma remains grim
.
31 children enrolled:
30 eligible & evaluable for survival & toxicity
.
Median age: 8 years (range 3-14 years)
7 - (23%) partial response following radiation
18 - (60%) stable disease
2 - (7%) progressive disease
3 - (10%) not measured
.
ALL 30 DIED
.
Overall survival at:
1 - year, 27 +/- 7%
2 - years, 3 +/- 2%
.
Median survival:
9 months (range 3-36 months)
.
Hematologic toxicity was significant; other toxicities included constipation, mucositis, emesis, & infection
.
Addition of vincristine & oral VP-16 to standard external beam radiation causes moderate toxicity & does not improve survival of children with diffuse intrinsic brain stem glioma
.
1/2005 - Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98)
www.ncbi.nlm.nih.gov/pubmed/15565574
Role of chemotherapy in treatment of children with newly diagnosed diffuse brainstem glioma is uncertain
.
Study tested efficacy of temozolomide treatment after RT
.
Patients 3-21 years were eligible
.
33 (median age at diagnosis, 6.4 years) enrolled
.
16 patients received window therapy:
6 - irinotecan treatment discontinued due to clinical progression
10 - experienced disease stabilization
.
29 received combined total of 125 cycles of temozolomide
.
Grade 3/4 neutropenia & thrombocytopenia occurred in 33% & 29% of all temozolomide cycles, respectively
.
In approximately 1/3rd of the cycles, dose reduction was required due to myelosuppression
.
ALL DIED of disease progression (median survival, 12 months)
.
Estimated 1-year survival rate:
48% (standard error, 8%)
Temozolomide after RT did not alter the poor prognosis associated with newly diagnosed diffuse brainstem glioma in children
.
3/2006 - Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
www.ncbi.nlm.nih.gov/pubmed/16484713?dopt=Abstract
2003 - 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/pubmed/12718563?dopt=Abstract
#229 Krebiozen
.
"That’s why Burzynski needs to complete a Phase III study if he is going to demonstrate any real efficacy of antineoplastons."
.
"Many of us strongly suspect that he hasn’t done so because they are not effective, not because of a lack of either funding or suitable patients as you have suggested."
.
Well of course!!
.
THAT explains why THOSE drugs got to skip phase III!!!
.
You would much rather not discuss funding or patient recruitment as you are still unable to provide any citations or references re your knowledge of said subject-matter.
#259 flip
.
Squidymus blathers
.
"Yeah, cause it’s not like those patients aren’t revealing all their confidential treatment info all over Facebook and fundraising sites and blogs. How dare we ask for info they’re publishing freely themselves in public places?"
.
Ahhhhhhh!! Then YOU CAN look up the names of children who had BRAINSTEM GLIOMA!!!
#235 W. Kevin Vicklund
.
"What was that about fact-checking?"
.
WeaKVision
.
Where's your head at??
.
Have you considered glasses or LASIK???
FTFY.
#239 Narad
.
"What was that about fact-checking?"
.
"It’s rather amusing that even DJT is unable to parse DJT."
.
Parse THIS!!!
http://lyrics.wikia.com/Nuclear_Assault:Whine_And_Cheese
#240 Krebiozen
.
DJT,
.
"What is the evidence for this claim?"
.
Where are the published results of a controlled study or studies that show that:
.
Afinitor, Avastin, Temodar, vincristine & oral VP-16 or Temozolomide "cure" BRAINSTEM GLIOMA in children???
#245 Marc Stephens Is Insane
.
Narad,
.
"Here’s a short essay Jimmy Wales wrote ... I like this guy!"
.
So do I. He's from BAMA Jam country, & looky here!!
http://en.wikipedia.org/wiki/Quack_Pack
It's y'all's show!!!
Methinks Didymus needs to explain why Burzynski has apparently been prevented by the FDA from giving antineoplastons to new patients.
http://scienceblogs.com/insolence/2013/02/08/will-the-fda-finally-slap-…
No, assmunch, you plainly demonstrated that you yourself are unable to figure out what's what in your in incoherent text barfs. A person of good will and sound mind, when corrected, thanks the person who made the correction and either retracts or refines the original statement. You, on the other hand, apparently think the appropriate response is a case of the rum fits.
Where has anyone claimed any such thing? You still don't appear to understand the tu quoque fallacy, which I assume is why you echo weird variations of the term in nearly every comment you make, like a deranged parrot. The fact that there is no effective conventional treatment for pediatric brainstem glioma is not evidence that Burzynski's p!ss panacea is effective.
#169. Orac
.
"Methinks Didymus needs to explain why Burzynski has apparently been prevented by the FDA from giving antineoplastons to new patients."
.
Methinks OracQuack needs to explain my above post #246
"A person of good will and sound mind". There's the problem right there.
Still waiting for the reply to this:
.
Post #173
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
Though I do enjoy your repeated attempts at "Misdirection."
http://en.wikipedia.org/w/index.php?title=Misdirection&mobileaction=tog…
It reminds me of THIS:
The Criminalization of Innovation: FDA MISDIRECTION in the Najarian and Burzynski Cases
.
Mine was posted 1st. Give up yet??? ;)
DJT made the following claim (slightly reformatted):
Here is what the link actually said:
So there were two studies, both of them had more than 56 patients, and only one of them had a median duration of 3.9 months.
What was that about fact-checking?
The logic DJT (and Burzynski) appears to be employing is that since there is no reliably effective conventional treatment for pediatric brainstem glioma, any survivor of this illness who was given antineoplastons must have been cured by the antineoplastons. This obviously doesn't follow as these cases may have been misdiagnoses, or rare cases in which conventional treatment was effective.
Jessica Ressel is a good example of an alleged antineoplaston cure of a pediatric brainstem glioma. As both Orac and Jli have observed, she apparently never had a biopsy, and her brain lesion shrank, grew, disappeared and reappeared in bewildering fashion bearing no relation to her dose of antineoplastons before finally vanishing (hopefully) forever.
Jodi Fenton's story is also highly suspect and has been dissected by Orac and jli, and probablt others who know what they're looking at and talking about.
Some people do get lucky and survive, for whatever reason.
Jodi Fenton's tumor was in her parietal lobe, and was very probably surgically resected. Brainstem tumors, especially diffuse ones, are more difficult to resect without doing serious damage - the brainstem is where a lot of vital functions are carried out. I think that's why Stan's brainstem glioma anecdotes are mostly (if not all) doubtful diagnoses.
Kreb,
Nu-uh! Merola said Stan cured her, so it must be true!
And it only took 2 days to make her tumor completely disappear. Antineoplastons started June 6. Tumor undetectable by PET scan on June 8. Miraculous.
Wow, DJT is still here.
@PGP
Being banned from Wiki, he probably has nowhere else to go.
#229 Krebiozen
.
“Many of us strongly suspect that he hasn’t done so because they are not effective, not because of a lack of either funding or suitable patients as you have suggested.”
.
Let me to "quote" from an article I've posted on the BlatherBlog, at least twice before; of course, not in the hope that anyone would actually READ it:
.
"He's in constant negotiations with the FDA, TRYING TO RAISE THE MONEY TO DO THESE CLINICAL TRIALS ..." added Jaffe
www.jag-lawfirm.com/burzynski-suit-kprc-02012012.html
.
http://m.click2houston.com/news/Houston-cancer-doctor-draws-new-complai…
Post #108 (2/2/13)
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-o…
Post #114 (1/20/13)
http://scienceblogs.com/insolence/2013/01/07/lets-make-dr-stanislaw-bur…
#237 Lawrence
.
"If old Stan ever put a quote like that in an SEC filing, he could easily be held liable (since he, most likely, has to sign off on the accuracy of everything in the filing, or be held criminally responsible) – so I’m not surprised that those links don’t say what Didums say they do….or that anyone would use SEC filing as a measure of Scientific justification for anything."
.
Waiting for y'all to hold SRB liable for the SEC filings ... in 3 ... 2 ... 1 ...
#264 Narad
.
Based on your “word salad,” ...
.
"FTFY."
.
Fennel Tomatoes Figs Yams
.
Yep ... “word salad." :)
#269 Narad
.
"You, on the other hand, apparently think the appropriate response is a case of the rum fits."
.
I don't partake of rum. It gives me "fits." ;)
#270 Krebiozen
.
"Where has anyone claimed any such thing? You still don’t appear to understand the tu quoque fallacy, which I assume is why you echo weird variations of the term in nearly every comment you make, like a deranged parrot. The fact that there is no effective conventional treatment for pediatric brainstem glioma is not evidence that Burzynski’s p!ss panacea is effective."
.
Yet some of y'all "parrot" the same old "tu quoque" "tu-quack" when the FDA approved phase III after FDA supervised phase II trials, which means they had the necessary data; without needing the "rubberstamping" of anyone here; just like the FDA hasn't needed anyone's elses approval for any other product, that in Japan they reported success with SRB's product, & in China & Taiwan, ROC, they approved the product; based on SRB's research, since 2004, as I posted: #88 & 89
http://scienceblogs.com/insolence/2013/01/22/another-way-to-join-the-sk…
#272 LW
.
"“A person of good will and sound mind”. There’s the problem right there."
.
Exactly!! Everyone knows that people who can't respond to my post #273 are "not quite right."
#274 W. Kevin Vicklund
.
"DJT made the following claim (slightly reformatted):"
.
"What was that about fact-checking?"
.
I guess you can ask Merola for the reason.
.
post #555 (12/19/12)
http://scienceblogs.com/insolence/2012/11/26/significance-of-the-tmb-di…
#275 Krebiozen
.
"As both Orac and Jli have observed, she apparently never had a biopsy, and her brain lesion shrank, grew, disappeared and reappeared in bewildering fashion bearing no relation to her dose of antineoplastons before finally vanishing (hopefully) forever."
.
You mean ALL of these were NOT "misdiagnoses?"
#276 Marc Stephens Is Insane
.
"Some people do get lucky and survive, for whatever reason."
.
THAT explains aspirin!
#277 Krebiozen
.
"I think that’s why Stan’s brainstem glioma anecdotes are mostly (if not all) doubtful diagnoses."
.
Yes, because its much more fun to "speculate" rather than to just get the "facts" from the doctors who I guess "misdiagnosed;" since they should have known that the patient could have gone on with their life while the tumor disappeared on its own.
#278 Marc Stephens Is Insane
.
"Nu-uh! Merola said Stan cured her, so it must be true!"
.
Yeah, it's not like Jodi said it.
#280 Politicalguineapig
.
"Wow, DJT is still here."
.
Still waiting for y'all's excuses for not responding to post #273.
#281 flip
.
"Being banned from Wiki, he probably has nowhere else to go."
.
See, I gave y'all plenty of time to comment on post #273. No comment. :)
What was that about fact-checking?
[btw, as near as I can discern, almost all of DJT's copy-paste screeds are from Merola's sites. Which raises the question of who DJT really is]
#295 W. Kevin Vicklund
.
"[btw, as near as I can discern, almost all of DJT's copy-paste screeds are from Merola's sites. Which raises the question of who DJT really is]"
.
And this just proves my point re post #263. ;)
@WKV
[quote][i] [btw, as near as I can discern, almost all of DJT's copy-paste screeds are from Merola's sites. Which raises the question of who DJT really is] [/i][/quote]
Agreed, especially since Merola has also been whingeing about Wikipedia's treatment of Stan and this whinging started at the same time Diddums was hit with the ban hammer there.
DJT outed as a paid shill of the slimeball. Surprise surprise.
Apologies for screwed up quotation - been spending too much time elsewhere!
@Didymus Judas Thomas - comment 173 at the link you included at 273 above was by Narad and doesn't appear to require any response.
Which post is this:
Which, in turn, isn't even a comment from you. Nice work, halfwit. There's a reason nobody is much responding to you (aside from simple mockery) and instead talking about you: you're unable to come up with anything coherent to respond to in the first place.
#3 Marc Stephens Is Insane
.
"I am also curious as to how this new development will affect the release of the second of Merola’s BS SB commercials due out “any day now.”"
.
This new documentary, tentatively to be released in SPRING of 2013, ...
http://en.wikipedia.org/wiki/Spring_(season)
If you could "fact-check" it might help
DJT,
I mean this patient's history is not consistent with a malignant glioma, since these tend to get bigger rapidly and kill the patient. A number of other of Burzynski's patients have equivocal diagnoses, for example Shontelle Hiron, whose doctors disagreed about the interpretation of her biopsy and who had 4 years of complex partial seizures before being treated, which is not consistent with a malignant tumor.
Without a biopsy it is not possible to definitively diagnose a brain tumor, and therefore you cannot assume that this was a malignant glioma that was cured by antineoplastons. There are other possibilities which need to be excluded before we can assume that antineoplastons are effective and certainly, in my opinion, before anyone starts charging desperate patients money for this unproven treatment.
By the way, when patients give permission for their records to be used for publicity purposes by Burzynski and Merola or present them as evidence of the efficacy of antineoplastons, I consider them fair game for speculation. You can check for yourself that there are no biopsy results among Jessica Ressel's records, that Shontelle Hiron's doctors disagreed about her diagnosis, and that Jodi Fenton's brain tumor was undetectable on PET scan a mere 2 days after commencing antineoplastons; all these records are on the Burzynski movie website or on Shontelle Hiron's website.
@Squidymus
It should be extremely clear by now that if I could understand what you're saying, I'd reply to it. Other people and myself have asked you to write like a normal person. You refuse to do so; you get ignored.
@W Kevin Vickland
I had a similar thought on another blog post. It would certainly explain a lot of his choices of attempting to look stupider than he is.
[reformatted so normal people can read it]
Is this the same Burzynski???
Thankyou very much Kerbiozen for relating to those points again.