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:

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.

Next up:

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.