Well, that didn't take long. I knew it had been too quiet on the Burzynski front. In retrospect, that was almost certainly because of the holidays, but the holidays are over, and real life is here again.
Yes, the year 2014 is only a little more than a week old, and here comes Stanislaw Burzynski again, hurt but not defeated in the wake of all the negative publicity he received late last year, thanks to Liz Szabo's USA TODAY expose. Actually, in a way it might have been a good thing that I was delayed in addressing this a day by my little bit of weakness Tuesday night that led mere exhaustion to keep me from my blogging duty. The reason is that Liz Szabo wrote a story about part of what I was going to write about, and that story appeared on the USA TODAY website last night Texas charges controversial doctor with false ads:
In a complaint filed Dec. 11, the Texas Medical Board said Stanislaw Burzynski marketed his experimental cancer therapies online and in news releases in a way that is "false, misleading and violated federal law."
In a statement Wednesday, the Burzynski Clinic dismissed the charges as "frivolous," arguing that he has a constitutional right to make truthful statements about his research.
The charges are the latest attempt by Texas medical authorities to discipline Burzynski, 70, who has wrangled with the state board since the 1980s over his use of experimental drugs that he claims can cure certain cancers.
You can also find the order here on the website of the Texas Medical Board (TMB) under the link to the date 12/11/2013, Docket Number 503-14-1342.MD.
Yes, basically, the TMB is going after Burzynski again, this time based on his marketing his cancer treatment, specifically, his "antineoplastons," even though they are not FDA-approved. This is based on a warning letter dated October 12, 2012. That warning letter was based on Burzynski's marketing of his ANPs on his website and other websites through documents, videos, and a variety of other means. It didn't mention Eric Merola's propaganda movie Burzynski The Movie: Cancer Is Serious Business, which was every bit as much an advertisement for Stanislaw Burzynski as anything ever published on the Burzynski Clinic or Burzynski Research Institute websites.
In the complaint, the TMB mentions that Burzynski's actions from then violated the Food, Drug, and Cosmetic Act, which prohibits drug manufacturers from making claims about the efficacy and safety of unapproved drugs. Make no mistake about it, Burzynski has been functioning as a pharmaceutical manufacturer ever since he left Baylor in 1977 to set up shop elsewhere in Houston to treat patients with ANPs while also setting up a manufacturing facility, where he first isolated ANPs from urine collected from various facilities around Houston, including Gilley's Bar and then later figured out how to synthesize them chemically. That's one of the reasons I haven't been able to figure out why the alt-med cancer cure crowd is so enamored of Burzynski, to the point that it will viciously attack his critics and defend Burzynski. What he's been doing for the last 36 years is, when you examine it, far worse than anything any large pharmaceutical company has done, and he's done it for every bit as mercenary an interest as any big pharmaceutical company. Do they realize that he's been playing them like a Stradivarius? (More on that later.) In any case, the TMB also notes that there have been aggravating factors, including "increased potential for harm to the public, prior similar violations and previous disciplinary action by the board."
In the days leading up to Szabo's story, there had been a number of indications that something was up. Actually, I had seen the charges posted a few days ago; likely they were posted to the TMB website not long after the first, and knowledge of them had been filtering out to Burzynski watchers. Burzynski knew that soon it would all be common knowledge, particularly once the date for his hearing before the TMB was announced. Also, before the holidays, Burzynski allies had been using patients with cancer as the human interest stories designed to encourage people, rather than donating money, to write to their legislators in Washington, DC to put pressure on the FDA to allow these patients to receive ANP treatment under compassionate use exemptions. I wrote about two of them in December: Elisha Cohen, a young Jewish child from Houston with an inoperable brainstem glioma whose plight led to articles supporting his cause as far away as Israel; Liza Cozad, who just so happens to be the wife of Sammy Hagar's drummer, who also suffers from a brainstem glioma; and McKenzie Lowe, a 12-year-old girl suffering from diffuse intrinsic pontine glioma (DIPG), a largely incurable form of brain cancer with an absolutely dismal prognosis. In retrospect, those efforts were merely the beginning.
Now that the holiday is over, over the last three days one of the most prominent pro-quackery advocacy groups in the country, scourge of any legislator trying to the Alliance for Natural Health USA (ANH-USA) launched a series of articles urging its members and followers to write to their legislators to lean on the FDA to allow Burzynski to treat patients under compassionate use protocols. But that's not all. The ANH articles also include broadsides against USA TODAY and Liz Szabo so full of misinformation and conspiracy mongering that they would not be out of place on NaturalNews.com or on Alex Jones' website:
- Dying Patients Denied Access to Dr. Burzynski’s Potentially Lifesaving Treatment
- Unbelievable! FDA Violates Patient Privacy Laws to Bring Down Dr. Burzynski
- Exclusive: Inside USA Today’s Smear Campaign Against Dr. Burzynski
If you want to understand how much contempt the ANH-USA has for its audience, I'll show you briefly through one passage from one of these articles, namely the third one. The ANH-USA complains that Liz Szabo:
Cites the lack of published random-controlled trials (RCTs) as evidence of antineoplastons’ uselessness, while omitting the fact that the efficacy of the treatment has recently been confirmed by a randomized, clinical trial by Japanese researchers. And of course ANH-USA has repeatedly had to point out that RCT’s are enormously expensive. Nobody but drug companies can afford them, and they will usually only undertake them if the treatment is under patent and therefore a government enforced monopoly. In addition, there is growing evidence that RCTs, particularly in the context of individualized treatments, should no longer be considered the “gold standard” for drug efficacy.
Of course, this is the same nonsense Burzynski's been peddling for the last couple of years about a vaporware randomized clinical trial carried out by Hidaeki Tsuda in Japan. This trial featured prominently in Eric Merola's second movie. Unfortunately, although the trial sounds interesting as described in Merola's movie, it has not yet been published. Hilariously, apparently Tsuda submitted his clinical trial results to the Lancet Oncology last summer, and it was rejected. Not only was it rejected, however, the manuscript appeared to have been editorially triaged, as in not being sent out for peer review. It's a common enough thing that happens to anyone who submits enough manuscripts to high impact peer-reviewed scientific publications. I've had it happen to a couple of manuscripts of mine. Usually what it means is that you aimed too high or submitted to an inappropriate journal. You brush yourself off and move on. At least, that's what most scientists do. Burzynski, however, set loose his propagandist Eric Merola to whine and rant about how it was all a pharma conspiracy that wouldn't let Dr. Tsuda publish in Lancet Oncology. More likely it was because the trial was poorly designed, the results not convincing, and/or other deficiencies that made triage an easy decision.
That's not the funny part though. (Well, it is funny, but it's not the funniest part.) Those of you who couldn't resist clicking on the link to the article cited in the ANH-USA rant already know the funny part. Take a look at the article, which was published in Oncology Reports (not the greatest of cancer journals) entitled Demethylation effect of the antineoplaston AS2‑1 on genes in colon cancer cells. Do you notice something? I did, immediately. More accurately, I didn't notice something, and that something was a clinical trial. This is nothing more than yet another in vitro study, and it's not even that compelling of one. It looks at the effect of antineoplaston AS-2 on colon the methylation status of colon cancer cells. It also uses enormous concentrations of AS-2, 2 mg/ml, way higher than is likely to be achievable in the bloodstream, even using the massive doses of ANPs that Burzynski advocates using. Yes, Burzynski really does have that much contempt for you that he tries to pass off an in vitro study as a clinical trial, counting on the fact that most people won't bother to click on the link and that most of those who do bother won't know that what they are looking at is not a clinical trial.
The rest of the ANH-USA's attacks are largely nothing more than regurgitations of past Burzynski excuses and attacks. For example, in one article the ANH-USA twists the cases of Liza Cozad and McKenzie Lowe to its own ends, all but saying that the FDA is evilly laughing and twirling its metaphorical mustache as Cozad and Lowe die:
In the course of its decades-long vendetta against Dr. Burzynski, the FDA has become deaf to the suffering of those patients for whom antineoplastons are their last shot at living a full, normal life. The FDA’s refusal to grant McKenzie and Liza access to Dr. Burzynski’s treatment is particularly egregious, considering the extremely limited treatment options for DIPG. As Dr. Wright told ANH-USA, “Dr. Stanislaw Burzynski has cured DIPG in some individuals with his 100% harmless antineoplastons, and FDA is denying this woman and this girl antineoplaston treatment!”
The only interesting thing in this dreary tirade is the revelation that Stanislaw Burzynski's good bud Julian Whitaker, antivaccinationist and quack extraordinaire, was the first to start promoting their stories. The same old tropes are there: Burzynski is a brave maverick doctor and a real scientist (the last time he was a real scientist was back in the 1970s); the FDA is persecuting him unjustly (it isn't; Burzynski has skillfully used political pressure to neuter it over the years with respect to his case); and that only Burzynski has ever cured DIPG (not true, both from the perspective of Burzynski's having ever cured DIPG and from the claim that there have never been any long term survivors of DIPG).
Next, not being able to win on the facts, the ANH-USA, very likely after having been fed its material by Burzynski or his lawyer Richard Jaffe, goes for the ad hominem attack against Liz Szabo and attacks against USA TODAY. First, USA TODAY is painted as pure evil and to dismiss the significance of FDA warning letters. First, apparently warning letters don't matter:
Part of the FDA’s job is to issue warning letters to drug, food, and dietary supplement manufacturers, as well as drug trial sponsors, in order to notify them of possible FDA violations and encourage voluntary compliance. Warning letters to drug study sponsors, called “483s,” are the most common: they account for about 60% of all warning letters. In 2012, the FDA issued 787 483s.
Although common warning letters aren’t particularly newsworthy, they can be effectively wielded as a political tool: warning letters have been used to censor consumer Internet speech and deny consumer access to at-home DNA testing. But there’s a new, even more alarming trend in warning letters: these interim letters, which have no legal significance, are being cited as evidence by state medical boards of practitioner misconduct.
Of course, this passage fails to mention multiple issues relevant to Burzynski's misconduct. First of all, the FDA Form 483s used as part of the basis of Szabo's story were followed up by not one, but two, warning letters, as I documented. Moreover, Szabo never claimed that these Form 483s were warning letters; rather, she described them as "inspection reports," which is accurate, given that Form 483s are given to the company's management after the inspection concludes. Moreover, the warning letters that were issued less than a month after Szabo's story was published pretty much listed the same deficiencies found in the Form 483s used in the reporting of the story—because Burzynski's responses, which, by the way, he published to his own website, were considered inadequate. The ANH-USA is flogging an issue that is not significant in order to make it seem as though there was some sort of grand conspiracy against Burzynski on the part of the FDA. As for Burzynski's response to the December warning letters, it's just a regurgitation of his hopelessly inadequate response to the original Form 483s, so much so that I'm debating whether even to bother to blog this new response by itself, given that I've responded to the same Burzynski claims once already. I might have to. Warning letters are indeed nonbinding, but once a company has made a response to them the nature of that response can effect how they are viewed.
The USA Today article sparked a media firestorm. In the process, however, they inadvertently revealed evidence of FDA misconduct and collusion between the FDA and USA Today:
- A high-level Burzynski Clinic staff member told ANH-USA that one concerned patient called the FDA to learn more about Dr. Burzynski’s innovative treatments, and the FDA sent the patient a link to the USA Today article.
- The FDA violated Burzynski patients’ privacy. “A lot of our patients were obviously very irked about the article, and called the USA Today team,” a Burzynski staff member told us. “The parents of one young patient called a USA Today reporter, who then sent the parents their own child’s confidential medical records—which the reporter had received from the FDA. The family frantically called us [the clinic], ‘I just got an email from USA Today, they sent me our son’s full medical records!’” The reporter had sent not only the son’s medical records, but those of other patients as well.
Notice that one key fact is omitted: Were the medical records scrubbed of identifying information? If they were, then there probably isn't cause for complaint unless other hints were given to the patient's identity. Of course the parent would recognize her own child's medical records by what's in them, but if there was no identifying information there then there was no way for them to know. Basically, we have no way of knowing whether this is true or not, but given the past track record of ANH-USA in terms of accuracy, I'd trust a respected reporter before I'd trust the ANH-USA or Stanislaw Burzynski. If Burzynski and the ANH-USA have evidence to support these charges, then let them present it. Until they do, this is just more Burzynski obfuscation.
Which brings us back to the article I cited first, in which through the ANH-USA, Burzynski insulted my intelligence. This article is nothing more than an attack on USA TODAY:
In recent months, USA Today has released a spate of anti-natural health articles:
- An adulatory (some might say “drooling”) review of Do You Believe in Magic?, Dr. Paul Offit’s flawed and deeply biased book demonizing dietary supplements and attacking high visibility CAM advocates like Drs. Oz and Mercola;
- An inflammatory “investigative report” equating dietary supplement manufacturers with criminals;
- And a series of shamelessly slanted articles smearing cancer pioneer Dr. Stanislaw Burzynski.
What is behind the mainstream media’s outright hostility to supplements and natural medicine? We can’t be sure. But we do know that the mainstream media as a whole would likely be bankrupt today without drug company advertising.
Yup. Because obviously it must be all that filthy pharma lucre that's driving USA TODAY to attack brave maverick doctors like Burzynski and heroic "natural health" advocates like supplement manufacturers.
What really irked Burzynski, apparently, is that USA TODAY wouldn't let him publish a rebuttal and make claims like the one I mentioned earlier, namely that Japanese researchers have "proven" that ANPs work, you know, the one backed up by a reference to an in vitro paper. Apparently the editorial page editors recognized nonsense when they saw it and stripped Burzynski's response of its unsubstantiated claims. Jaffe claims that the letter cited "hard statistics." Unfortunately, none of these statistics appear to have been published in the peer-reviewed medical literature, in much the same way that not a single one of Burzynski's phase II clinical trials has seen its complete results published in the medical literature.
Finally, just yesterday, Burzynski responded to the TMB allegations in that time-honored traditional method, the press release. The first thing I noticed is that this press release is horribly written. Really, it's wretched. I can't help but wonder who wrote this dreck. Next, I noticed that the arguments in the press release are even dumber than usual:
The Burzynski Clinic (BC) announced today the preliminary response to the allegations in the lawsuit filed by Texas Medical Board (TMB) at the Texas State Office of Administrative Hearing on December 11, 2013 against Stanislaw R. Burzynski, M.D., Ph.D. (SRB). The allegations claim that SRB used internet-based advertising regarding antineoplastons (ANP), and that it was false, misleading, and violated federal law. The allegations can be divided into concerning preclinical and clinical research. The TMB claims that the terms used by SRB for the description of the mechanism of action of ANP, such as, molecular switches that cause the death of cancer cells, but do not inhibit normal cells and that ANP are multitargeted agents, are false and misleading. These terms were introduced in numerous publications in peer-reviewed journals and presentations at medical meetings by SRB and outside researchers, and represent findings of medical research permitted by Federal Law.
Actually, unless the Burzynski Clinic has more information than is contained in the actual complaint, the TMB said nothing of the sort. What it did charge is that Burzynski promoted ANPs as safe and effective even though ANPs are an investigational drug and federal law prohibits promoting an unapproved drug as safe and effective. In my mind, there's no doubt about that. I do worry about the TMB's strategy, though. Jaffe is clearly trying to claim that an "informal" FDA letter is not a basis for a case. He might succeed. More and more, lawyers representing defending big pharma urge companies accused of wrongdoing in state courts to contest the admissibility of FDA warning letters and are, in some cases, succeeding. The question of admissibility of FDA warning letters has become a hotly contested issue in the legal world. The TMB could well lose unless they have a lot more evidence than the FDA warning letter. Win or lose, though, it's good to see that the TMB hasn't completely given up on trying to strip Burzynski of his medical license.
Sadly, I look forward (not eagerly) to much more of this sort of thing. Burzynski knows that the USA TODAY articles were a hit below the water line. He's listing and taking on water. He needs to stop the water pouring in, fast, and start pumping it out, or he will sink. Lacking evidence and science, his only tools consist of the same tools he's always used: Smear tactics against his enemies, cherry picking or twisting existing evidence, obfuscation, and shamelessly using dying patients to tug at the public's heartstrings and persuade the to do his dirty work for him. I foresee a lot of this in 2014. Although I hope that the pressure from the FDA having shut down his clinical trials and the TMB once again trying to go after him again will finally result in the Burzynski Clinic being shut down, I fear that this will not be the case and that, come 2015, Burzynski will not even have moved to Tijuana. What I don't want to be doing is fighting the same battle this time next year, but, given Burzynski's protean ability to evade significant penalty, I fear that 2015 will begin much as 2014 has with respect to Burzynski.
This is nothing more than yet another in vitro study, and it’s not even that compelling of one. It looks at the effect of antineoplaston AS-2 on colon the methylation status of colon cancer cells. It also uses enormous concentrations of AS-2, 2 mg/ml,
As the excellent xkcd cartoon put it, it may kills cancer cells in a Petri dish, but so does a handgun
Actually, in this instance the handgun may do a better job.
We can’t be sure. But we do know that the mainstream media as a whole would likely be bankrupt today without drug company advertising.
Ah, the smell of the Pharma chill gambit in the morning...
I also like the "we can't be sure but we will put forward our evidence-free accusations anyway" format. Life is so much more simple when you don't have to take responsibility for your opinions.
Funny enough, the ads I remember from my newspapers and magazines are mostly for banks, personal insurance, incoming TV shows and live entertainment, so I doubt mainstream media would go bankrupt if pharma ads were removed. But it could be confirmation bias on my part.
But we do know [...] would likely be
"Know" and "likely" do not really belong together in a sentence in this way, cancelling each other out, Pop goes the Weasel-word.
"This is nothing more than yet another in vitro study, and it’s not even that compelling of one. It looks at the effect of antineoplaston AS-2 on colon the methylation status of colon cancer cells. It also uses enormous concentrations of AS-2, 2 mg/ml,..."
Why did they even bother to use antineoplaston AS-2 on colon cancer cells in a petri dish?
They could have used Saline solution. Hypertonic saline through osmosis would cause the cell to swell and burst. Hypotonic saline through osmosis would cause the cancer cell to shrivel and die. (Simply a matter of knowing intracellular and extracellular fluid balances).
Hypertonic saline through osmosis would cause the cell to swell and burst. Hypotonic saline through osmosis would cause the cancer cell to shrivel and die.
Sorry lilady, but as a pedantic clinical biochemist I feel obliged to point out it's the other way around. A lot of people get osmosis confused - water (not solutes) moves across semi-permeable membranes in osmosis. Red blood cells will hemolyze if added to hypotonic solutions (such as water) because the concentration of salt (and other substances) inside the cell is greater than in the hypotonic solution, so water moves into the cell through osmosis until it bursts. Conversely, a red blood cell in hypertonic saline will have the water sucked out of it.
"And of course ANH-USA has repeatedly had to point out that RCT’s are enormously expensive. Nobody but drug companies can afford them, and they will usually only undertake them if the treatment is under patent and therefore a government enforced monopoly. "
Don't you think that if there were anything to ANP's at all, a drug company would have snapped up Burzynski's operation long ago and done the trials properly?
Killing cancerous cells in a Petri dish is easy, I did it several times during my PhD, just by forgetting to put them back in the incubator.
"Don’t you think that if there were anything to ANP’s at all, a drug company would have snapped up Burzynski’s operation long ago and done the trials properly?"
I just had the same thought. I imagine he or his people desperately trying to sell it to companies, companies running it by their very well paid scientists, the scientists saying there's nothing to it, and the companies turning him down. Can you imagine? If the pharma conspiracy is so vast, why hasn't pharma stolen his technology or offer to buy it for billions of dollars?
If he just wants to help people, getting the backing of a multi-billion dollar multinational pharmaceutical would go a long way to getting his "cure" out to the public.
Also, RCTs are not that expensive, not for someone who's been charging thousands of dollars for mere access to something that has been experimental for years. All he had to do was get 10 patients, give 5 the antineoplastons, give 5 the conventional chemo, and see what happens. How much would that cost him if he's charging thousands?
The problem is that people desperate for a cure to the incurable get tunnel vision and can't see the BS in this whole thing.
Ah yes, the ANH!
Sceptics should familiarise themselves with the ANH's three pronged attack:
I know of Robert Verkerk for at least 10 years; there are 3 websites ( Europe, US, International) .They have plans for global domination through legislation and legal actions- their ideas seem to underlie much of the crap we hear and read from woo-meisters.
THAT almost sounds like a conspiracy.
"If the pharma conspiracy is so vast, why hasn’t pharma stolen his technology or offer to buy it for billions of dollars?"
If you believe the Burzynski acolytes, the Government (undoubtedly aided by the Pharma Lizard Conspiracy) has been trying to "criminally suppress" Burzynski in order to his patents. It's a major part of the paranoiac pro-Burzynski fantasy world.
Make that "in order to steal his patents".
On a somewhat lighter note:
I commented about that scurvy, woo-drenched organisation which Orac mentions above and it disappeared. TWICE.
Infiltration by anti-SBM?
Here is a naive jurisdictional question from a non-lawyer: If the complaint is that Burzynski is violating federal advertising laws, why is the Texas Medical Board pursuing the case? Normally, false and deceptive advertising falls in the FTC's bailiwick.
The structures of the ANP's Burzynski has been adminsteriing are known: AS 2.1 is phenylacetic acid and AS 10 is phenylacetyl glutamine. Both are metabolites of sodium phenylbutyrate, a drug used to treat urea cycle disorders and which has been looked by independent researchers and mainstream pharma companies as a possible treatment for various cancers--lung, prostate, etc.. No indications of efficacy has been found.
So it's easy to see why no drug company is interested in buying or stealing his 'technology'-- they already know it doesn't work.
Also, RCTs are not that expensive, not for someone who’s been charging thousands of dollars for mere access to something that has been experimental for years.
One might also wonder why he has had on the order of 60 open clinical trials for decades. Surely he could have pared that number down to save up the money needed to run a proper RCT toward FDA approval. And, as you point out, with people paying to volunteer (a rather questionable practice in itself), he should have had no problem coming up with the funds.
Making false or misleading claims can be actionable by the Texas Medical Board, according to the state's professional licensing regulations. Take a look under section 164.052(a), especially subsections 5 and 6. Also see section 164.053(a), with subsections 1, 5, and 6 possibly coming into play.
Somewhat on topic, I noticed one of the News/Ad links on msn today for Envita:
They not only treat cancer, but also, Lyme disease, chronic disease (whatever?), chronic fatigue syndrome, and a few others.
There is a link for testimonials, but not for published evidence.
Also, there's a lot of handwaving about genetically targeted chemotherapy, which seems to consist of using lower doses to let the resistant cells survive and replicate.
More blog fodder.
As the excellent xkcd cartoon put it, it may kills cancer cells in a Petri dish, but so does a handgun
I was thinking of that one too.
100% harmless antineoplastons
Drugs described as completely harmless tends to come in two flavours: those that are anything but, and those that are homeopathic. Has anyone invented homeopathic antineoplastons yet?
I see the TMB is taking the "Al Capone" route which in the absence of anything else will hopefully work. However will they be able to shut down the clinic or just prevent Burzynski from "practising"?
Stan must have several doctors working for him staffing his bullshit clinic. I hope he pays them well enough to retire when he gets closed down because having his name on your resume cannot be a real positive employment activity.
Has anyone invented homeopathic antineoplastons yet?
Give me 20 minutes. I've already got a bathtub full of water. I'm just waiting for the opportunity to collect a splash of MSU.
Question: Could the TMB legally use the testimonies online and at TOBPG, in which scores of patients report that they were told that ANPs are non-chemo, safe and effective?
Question: Could the TMB legally use the testimonies online and at TOBPG, in which scores of patients report that they were told that ANPs are non-chemo, safe and effective?
I'm not sure what precise rules of evidence they're governed by, but it's a safe bet that the answer is no.
Earlier, my comments about the Alliance for Natural Health were eaten ( so here goes):
I know about the European branch's Robert Verkerk for more than 10 years- he seems to be the overlord of the entire tri-partite, international organisation ( Europe/ US/ International). There is no woo which is beyond their purveyance and they seek legislative and legal means to spread it around. It's worth taking a look at their websites and facebook pages. Sceptics need to know about them and their work.
Orac -- so I assume from this you are NOT going to be signing the White House petition to allow a patient to be given Burzynski's ANP woo therapy? https://petitions.whitehouse.gov/petition/authorize-fda-grant-compassio…
Doug, what reasonable adult would sign a petition allowing Burzynski to administer to a child a drug which 1) causes serious and potentially lethal side effects, such as extreme hypernatremia (recall the petition is necessary because the FDA issued a clinical hold following the death of a child undergoing treatment) and 2) for which there exists no evidence whatsoever it is effective in treating advanced cancers?
@JCG--I'm pretty sure I detected a smidgeon of sarcasm in Doug's comment, and my sarcasometer is pretty darn sensitive. I'm also wondering just how "compassionate" antineoplastons are.
Anyone who has read my prior comments on this blog (my son had leukemia, and was saved by science, not by some damn woo), would be correct in believing that my comment was purely sarcastic.
I am certain the documents had all PII redacted. It is easy to trace a Burzynski patient: they have to run appeals to cover the extortionate cost. All you have to do is follow the care bridge links and so on.
Liz Szabo is a journalist, tracking down sources is what they do. And the signs are that the sources were in place before the FDA released anything. This kind of story takes months to build and fact check, after all.
If Antineoplastons were "100% harmless" then they wouldn't be able to kill cancer cells either.
This man and his organisation are unconscionable.
Whoever it is in the TMB who seems to have made it their mission to get this quack deserves a medal. It must have been a frustrating job so far, but they've kept at it.
If the TMB manage to nail Count Stan this time (and I share Orac's pessimism on this), what is there to stop his clinic carrying on regardless with his son, Mini B, nominally in charge? As MikeMa pointed out, future alternative employment prospects for his staff doctors would be limited.
I seem to recall that last time the TMB had a go, Count Stan succeeded in arguing that he was not responsible for the clinical decisions of his staff, so the case foundered. With this precedent he may be able to continue to separate himself from his minions.
Whoever it is in the TMB who seems to have made it their mission to get this quack deserves a medal.
Given the track record, I'd say not. The invented cause the last time around was just embarrassing.
January 9, 2014
The structures of the ANP’s Burzynski has been adminsteriing are known: AS 2.1 is phenylacetic acid and AS 10 is phenylacetyl glutamine. Both are metabolites of sodium phenylbutyrate, a drug used to treat urea cycle disorders and which has been looked by independent researchers and mainstream pharma companies as a possible treatment for various cancers–lung, prostate, etc.. No indications of efficacy has been found.
So it’s easy to see why no drug company is interested in buying or stealing his ‘technology’– they already know it doesn’t work.
They Did they claimed patents in the patent office submitted numerous ones till the government strong armed the U.S Patent Office to grant the government the patent on it, that Dr. Burzynski already had a patent on years earlier, hmmm why would that do that if hes a quack , cause they know he has 20 years of experience and they want the wealth and the credit, the Government always Steals things from us, and get away with it too !! And for this conventional Dr. to Blog against him, cause he doesn't understand and doesn't have the years of knowledge only conventional methods and sides with a government that probably gives him some kick backs somewhere along the line. He in my opinion is the Quack cause, he won't think outside the box and go beyond conventional medicine that has killed as many or more then its saved. Radiation, Chemo Therapy... Hmmm lets see lets use something so radical and known to be harmful to humans to kill cancer and do a number on their organs to and put them thru needless side effects, I don't think the people, or their children that were treated by Dr. Burzynski, would stand up in court and lie about what beneficial results they or their loved ones had under his care and treatments, Doctors of conventional medicine will always scoff, cause they know that if something takes away their kick backs from the drugs or treatments that the big pharm companies give them, they will be losing out, so as long as they defend conventional and put patients thru needless suffering in the name of what the FDA tells them cause if it doesn't benefit the government, if they are in control and get the biggest piece of the pie, They will not let anyone else do anything good for the people all government is No. 1 : How Much Money is in it for them. So they Regulate and Dictate outcomes, and pass drugs that big Phram produce, with terrible side effects, and it only masks the problems, I don't think I have ever seen a commercial for a drug that they advertise and push that didn't give you numerous side effects, but that is alright we have a drugs for those to... to make more money off patients. and give them false hopes!!!
The Doctor who post these blogs should be the ashamed, for his rants, when he should be working with other Doctors and learning from them. He will be accountable, for his blog attacks and Slander!
Soulman - You know what would really mute Dr. Burzynski's critics, get the regulators off his back, and make Orac metaphorically whimper with his metaphorical tail between his metaphorical legs? You'll never guess!
If he were to publish the full results of clinical trials showing that he gets better than standard outcomes for his treatments than for conventional treatments, and if those results could be replicated by independent organizations, then that would really show 'em.
Are you ready to hold Dr. Burzyinski to the same standard you'd use for a real drug company?
@Soulman - just how much science and statistics do you know?
Have you read anything about this, or just watched the two "paid advertisements" created by Burzynski's greatest fan?
For this blog to be slander, it would have to be false. Strangely, this cancer researcher has been posting about this "brave maverick doctor" for years now, and has yet to be successfully sued (though there have been bullying attempts).
Please, if you or a loved on has cancer, meet with a board certified oncologist and learn your options. If for no other reason so at least you can recognize the regular chemo that might be offered to you, at significant markups, as part of the treatment protocol at Burzynski's clinic.
PS - ANPs cause nausea, hypernatremia and other significant side effects, just like dreaded chemo (and moreso than some of the newer ones) while being less likely to cure cancer at the dosage levels administered ;-)
they want the wealth and the credit
Let me see if I got it straight:
Someone - either pharma companies or the US government, they seem to be one and the same - registered the patents on ANP so they can claim credit and make big money out of it.
And yet no-one but Burzynski is selling ANPs as anticancer drugs.
They forget to follow up on their theft? Not very consistent schemers, are they?
sides with a government that probably gives him some kick backs somewhere along the line [...] their kick backs from the drugs or treatments that the big pharm companies give them
Interesting variation. We got simultaneously the Pharma Shill gambit and let's call the first one the Government Shill gambit. They are one and the same, I tell you!
With all the money all of these people are giving to us scientists and physicians, I wonder why they are not bankrupted on a monthly basis. And why we bother writing grant applications. Plus, the checks they send me keep getting lost in the mail. A pity, my lab could use a bigger budget.
lets use something so radical and known to be harmful to humans to kill cancer
Cancer cells are human cells gone rogue, you poppyhead. Go read a biology book if you don't believe me.
So of course most of the things harmful to cancer cells will be likely to be also harmful to normal cells. The trick is to find something specific of tumour cells, and there aren't many. And to top it, cancer cells don't sit idly, but react and adapt to changes in their environment. Given enough time, they evade the immune system and become resistant to drugs.
More generally, anything which is biologically active is very likely to have more than one effect: all processes in our bodies are interconnected, you cannot prod one without some risk of interfering with another.
tl;dr: you cannot have an active substance, especially something like a cell-killer, without side effects.
Or else, this substance may well be, in fact, inactive and useless.
to make more money off patients. and give them false hopes
You just described Dr Burzynski's method.
Re soulman @33 --- I wonder if there's some deep reason why conspiratorial thinking tends to be associated with an aversion to paragraph breaks.
That's not just snark -- it's kind of interesting. Does the tendency to obsessively spin out lengthy, fragile chains of causation also make it difficult to parse an exposition into paragraphs?
I see this lack of structure more as people writing as they are talking: just chaining sentences as these are coming to mind, not feeling the need to order either their thoughts or their sentences.
I blame the medium: internet communications are supposed to be fast (well, instantaneous, but it's the same, right?). My hypothesis is that these people are not writing to you, but are in fact arguing with their computer.
Almost everything you wrote is blatantly untrue, and you are libeling a cancer surgeon and researcher who has done more to help cancer patients than Burzynski will ever do.
When you claim that conventional medicine, "has killed as many or more then its saved", you are simply lying. Our life expectancy has been increasing for decades and cancer patients are surviving for longer than ever before. Today 65.8% of patients diagnosed with cancer will be alive in 5 years time, as compared with 48.7% in 1975.
Most the patients in Burzynski's testimonials were successfully treated with surgery, chemotherapy and/or radiotherapy, and Burzynski has unjustly taken the credit. Others may not have had cancer in the first place - we don't know because biopsies weren't done. Are you aware of all the patients who did not survive Burzynski's treatments?
Burzynski's treatments include conventional chemotherapy, and even his antineoplastons have severe and sometimes fatal side effects, yet we have no reason to believe they are effective against cancer, unlike conventional treatments.
@soulman -- you have absolutely no idea what you are talking about. Conventional therapies have not killed these patients. Some patients using conventional therapies die -- and far more would die if they do not take the conventional therapies. The fact that some die is not a reason to discontinue the contentional therapies.
As an example for you, my son had high risk Acute Lymphoblastic Leukemia (ALL), diagnosed at age 15. He had 3 1/2 years of conventional chemotherapy.
He is now 25, almost 7 years off treatment, a college graduate, going to grad school, and doing fantastically. He goes mountain climbing, rides in 200 mile bike races, and, most of all, is alive.
Had he been diagnosed 40 years ago, he would have had less than a 20% chance of survival. NOW, after 40 years of research and improvement in the traditional chemotherapies (and other therapies), the success rate for pediatric ALL patients like my son is approaching 90%.
All done through clinical trials, with peer reviewed science, not anecdotal claims of woo.
My apologies, Doug. Sometimes it's hard to keep track of the players here without a program in hand.
I don’t think the people, or their children that were treated by Dr. Burzynski, would stand up in court and lie about what beneficial results they or their loved ones had under his care and treatments,
I'm not aware that any of the people who have themselves been treated or had their children treated by burzynski have offered testimony before a court of law. testimonals posted to the internet, yes, but that's hardly the same thing.
And in any case such testimony before a court wouldn't be evidence that antineoplastons were effective at treating advanced cancers, only that those giving the testimony believe that they are (i.e., they may not be consciously lying but simply be mistaken.)
I don’t think I have ever seen a commercial for a drug that they advertise and push that didn’t give you numerous side effects, but that is alright we have a drugs for those to… to make more money off patients. and give them false hopes!!!
All drugs approved by the FDA must have successdfully demonstrated they are effective at treating the diseases or injuries they're indicated for in large scale Phase III clinical trials. That isn't anoffer of false hope but of genuine hope.
Selling them on a treatment for which there is no evidence of efficacy, as Burzynski does with antineoplastons, is selling false hope--at wholly unjustifed and exorbitant cost, as well.
I think it's high-time for a tee-shirt which reads "Citation ****ing needed"
Selling 'em might make up for those pharma lucre checks that keep getting lost in the mail....
If Burzynski's treatments are so successful, why doesn't he publish the results from his numerous clinical trials? And don't give me "he's being peeeeeersecuted out of the journals"--it's 2014, there's a thing called the internet, he could write up his results in the form of a journal article and put them out there to be examined, if they so speak for themselves.
Johanna -- Zazzle has "citation needed" shirts (not quite as emphatic as your version, but you can totally make them that way too with Zazzle), and XKCD's store lets you buy packs of "citation needed" stickers. Hmmm....what could we do with the stickers?
When you look at some of the stuff tht does get published--Tomljenovic and Shaw, anyone?--it's hard to buy burzynski's claims that he can't get teh studies out there somewhere, in some forum.
The book Do You Believe in Magic that was so disparaged is only 1.99 on Amazon today, thanks Burzynski for pointing it out, it looks really good
Krebiozen @ #4:
"Sorry lilady, but as a pedantic clinical biochemist I feel obliged to point out it’s the other way around. A lot of people get osmosis confused – water (not solutes) moves across semi-permeable membranes in osmosis. Red blood cells will hemolyze if added to hypotonic solutions (such as water) because the concentration of salt (and other substances) inside the cell is greater than in the hypotonic solution, so water moves into the cell through osmosis until it bursts. Conversely, a red blood cell in hypertonic saline will have the water sucked out of it."
Thanks for the correction...now listen to my lame excuses for posting that dumb comment...and for not posting in reply to you.
1. I am still suffering from the East Coast strain of the crud that debilitated Orac last week.
2. I finally went to the doctor and I am on a six day regimen of solumedrol prednisone and a steroid inhaler BID, plus codeine cough syrup so that I can have some restful sleep.
3. I'm using my 'roid rage to post comments at crank anti-vaxxers on other science blogs and on popular internet media blogs.
4. My dumb comment was posted at 4 AM EST. :-)
I'm just finishing up "Do You Believe In Magic", courtesy of my local library. Good read, very interesting. Makes me wish I had a few dozen e-copies to distribute among my social circles.
@Calli - I adore XKCD but I think we need an emphatic version of the shirt/sticker. ;)
The problem with conventional chemotherapies is that they lack specificity: they kill normal cells in the same time that they kill cancer cells. As a consequence, they kill people without discrimination. The good thing with alternative medicine is that it kills specifically morons.
Had to smile a BIT at that, Daniel. Then immediately was sad. It really isn't that it kills morons. It kills frightened people who are more comfortable with what sounds like sincere promises of a cure than with the honest assessment of a doctor trying their very best to explain what the evidence proves they can do.
Most people do NOT have a very good understanding of science, so it's easy for them to be misled by the explanations of woo sometimes. It is why skeptics should do their best to always politely educate people in the debate.
I just wish that science and medicine were not do demonized by alt medicine. With the internet it makes it very hard for a patient to be certain that they are making a "safe" choice when they are treated by conventional medicine. :(
@ Mrs Woo
I was joking, and you don't have to be sad. Alternative medicine actually kills few people, morons or not. It just takes their money.
@Daniel - the "alternative medicine" might kill few people by itself, but what does kill large numbers of people is their lack of utilizing real medicine in the first place....
I was reading some blogs and articles about the human brain project and I found this gem:
I'd really like to know what the author is smoking.
To return briefly to the subject of Burzynski fighting back in 2014: are we sure he is bothering?
His normally closely monitored facebook presence, where previous censure was quickly removed, has been allowing direct criticism, accusations of quackery and thinly veiled insinuations of fraud since Thanksgiving.
Can we dare to hope that he has actually give up the fight? Or is his long expected move to "warmer climes" imminent?
Mark, I was unable to find a facebook page for burzynski. Do you have a link?
I don't think that Burzynski's lack of presence on Facebook means he's given up. It means he's given up on Facebook and is pursuing other means of promoting his cause, specifically conning people to lobby their Senators and Representatives to put pressure on the FDA to allow compassionate use exemptions for antineoplastons and getting the ANH to join in, as well as to attack USA TODAY and Liz Szabo.
Burzynski hasn't really done much on Facebook in a long time, and he seem to have (mostly) abandoned Twitter as well. If you check out the #Burzynski hashtag on Twitter, most of the activity is now anti-Burzynski, with only a few diehards or newbies promoting him. Even Eric Merola (@BurzynskiMovie and @Eric Merola) rarely shows up anymore, and the most obnoxious Burzynski Twitterer of all, @BurzynskiSaves (which most of us suspect used to be run directly by someone in the Burzynski Clinic), which was taken over by the Burzynski Patient Group last summer, is only sporadically active.
My conclusion? I think that skeptics have been very successful in changing the balance of power in social media with respect to Burzynski, and he's decided it's not worth it any more to fight his battles there. That's why we really have to counter this nonsense about using dying patients with brain tumors to tug on the heartstrings of people such that they write their lawmakers.
Social Media is also a two-edged sword...sure, it allows you to reach a whole lot of people, but it also gives your detractors equal access....so your target audience can easily see "and google" the other side.
By going to politicians directly, it prevents the kind of backlash he found on the Facebook / Twitter feeds.
IMO, the families and their close supporters are putting pressure on the families' Representatives in congress and Senators in Washington. A little effort from them=more votes.
I'm willing to bet that Burzynski has, for years, sucked up to Congressmen/Congresswomen and Senators, most of whom are clueless about basic chemotherapy. He probably has made donations to PACs, reelection committees and has purchased entire tables at fund-raising dinners.
If we were able to find out which Federal elected reps are applying pressure in Washington, I know a science blogger who will do a bang-up job of finding out who Count Stan is funding.
Orac: Good analysis about social media.
I don’t think the people, or their children that were treated by Dr. Burzynski, would stand up in court and lie about what beneficial results they or their loved ones had under his care and treatments,
And therein lies the problem. The dead can't speak. How many patients survived this treatment vs those who did not? What is their outcome compared to other forms of treatment? Were some of these patients receiving other forms of treatment in addition to ANP? Were patients who dropped out or failed to follow the treatment or diead counted as successes or failures or simply ignored? And so forth. Simple questions really.
If Burzynski had the cure for cancer, why is he not publishing results? That is how it is meant to work. Videos of teary eyed testimonials and inspirational music are no substitute for hard data. Real scientists would publish so their results can be replicated and a treatment developed that would help as many people as possible.
I think it is clear to most people why he doesn't publish - his treatment sucks. And if he published he would be shut down and his stream of revenue would dry up. But on the plus side I bet he has a magnificent house.
Interesting tidbit about Liz Szabo's article (from this source): before she started researching the article, she did what was essentially a book review of a book about alternative medicine. Since part of the book was about Burzynski, she emailed him asking for his response to the book before she wrote the review. As a response, Burzynski didn't give his side of the story, but instead had his lawyers send a preemptive legal threat.
There's a new website that just went live a few days ago called ANP Coalition. It's being run out of Clayton, California, which is also where Ric Schiff, from the Merola commercials, lives. Since Schiff now works for the clinic (a true paid shill!) it's safe to assume he's behind this new website.
It's worth sending some time poking around the various sections of the site. As Orac would say, it's target-rich.
Primarily a lobbying site, it prominently announces that the Burzynski Clinic now has a lobbyist in Washington, a lawyer who defended the clinic back in the 90s.
There's a page dedicated to the same five people Orac discusses above ("New Patients"). But there is also a Q&A page. Some excerpts for your enjoyment:
Q: Is ANP toxic?
A: Yes, ANP has a benign toxicity. There are no long-term toxic side-effects.
Q: How does the toxicity of ANP compare to “conventional” Cancer treatments?
A: ANP does not have any known long-term toxic side effects as common cancer treatments do. ANP works on a completely different principle so the mechanics of other treatments are not comparable to ANP (refer to our “What is ANP” button on the Home page).
Q: Has ANP shown efficacy on any other illnesses or diseases other than cancer?
A: In the early 1980’s and 1990’s, studies showed benefit in the following diseases; HIV, Lupus, Multiple Sclerosis, auto-immune diseases.
Q: Have any randomized controlled trials showing the effectiveness of antineoplastons been published in the peer-reviewed scientific literature?
A: Yes. An independent randomized clinical study has been completed. That study is pending peer review publishing. The authors have no control over the time table involved. The abstract of the clinical study done by the Japanese doctors have been published. Portions, excerpts and case studies have been published. Refer to our “Publications” button.
Q: Has ANP been identified and published in “peer-reviewed” data/Journals?
A: Yes, it has. Please note our “ANP Publications” button on the home page.
Q: Are the completed ANP Phase II Clinical studies published in Peer Review Journals?
A: Yes. Portions, excerpts and case studies have been published. The publication of several complete FDA Phase II clinical studies is currently pending Peer Journal review. So is a completed Independent randomized Clinical Study. The authors of these studies have no control over when the studies will be published.
The "five patients" Orac wrote about was in this post, not the one above, just to clarify:
ANP has a benign toxicity
It is reassuring to learn that anyone who dies of it does so benignly.
What does "benign toxicity" even mean? How can someone seriously say that with a straight face?
We know death is one of the possible side-effects of ANPs, due to hypernatremia. I guess death isn't a "long-term toxic side-effect" since you don't keep dying?
We know death is one of the possible side-effects of ANPs, due to hypernatremia.
In fact, we know that ANP's have caused a patient's death as the result of hyponatremia--that's why the FDA placed a clinical hold on further trials at Burzynski's clinic.
Exactly, JGC. They should not be able to deny that one, and yet they happily go on like it didn't happen. Like they didn't actually kill a patient with ANP. Either they're sweeping him under the rug, or they don't think death is an adverse side effect. Either way, it's bad, and more potential patients need to know about it.
It is all marketing to them. :-(
In my honest and very humble opinion, marketing does not belong in medicine, proven or woo.
Do you think those that wrote Nazi propaganda felt good about it? Way to write with extreme bias and cut out any debate that opposes your positions. You are what's wrong with western culture.
veritas - please don't sugar coat it, tell us what you really feel. More important, please say what you disagreed with.
Way to write with extreme bias and cut out any debate that opposes your positions. You are what’s wrong with western culture.
I'm sure that Kim Jong-un, Than Shwe, Hu Jintao, Abdullah bin Abdulaziz Al Saud, Islam Karam, Omar Bashir, Robert Mugabe, and a long list of other "leaders" who are not fettered by "western culture" will appreciate your nod to their liberal tolerance of dissent.
"Do you think those that wrote Nazi propaganda felt good about it?"
While Dr. B's supporters have sometimes taken a page from the Nazis (the threats against the familes of those who expose Dr. B's lies are a good example), it trivializes the vast scope of the Nazis' crimes, to make too close a comparison between one fraudulent doctor (no matter how corrupt), and the Nazi's regime.