NOTE: Special thanks to Jann Bellamy for advising me regarding the legal aspects of this post.
There are times when I fear that I’m writing about the same topic too many times in too brief a period of time. Most commonly, I notice this concern when writing about the lunacy of the anti-vaccine movement. In fact, it’s fairly rare that I feel it for any other topic. There is, however, one topic other than antivaccinationist assaults against science and reason that will sometimes obligate me to go on a roll such that I might write multiple posts in a short period of time. I’m referring, of course, to the dubious doctor known as Stanislaw Burzynski, a man who charges desperate patients with advanced (and usually incurable) cancer tens and even hundreds of thousands of dollars to participate in his “clinical trials” of antineoplastons, compounds that he claims to have isolated from urine and that he now represents as a promising new treatment that can do much better than existing therapies with much less toxicity, even though there’s no evidence that it can. He’s even starred in his very own documentary, which his very own propagandist Eric Merola, used as a paean to the greatness that Burzynski obviously considers himself to possess. The documentary was awful, full of biased misinformation and overall just a plain bad movie. Lately, Burzynski has been claiming to use what he refers to as “personalized gene-targeted cancer therapy,” which is more appropriately described as “personalized therapy for dummies,” given how incompetently it is carried out and the manner in which Burzynski mixes and matches very expensive targeted therapy and chemotherapy in ways guaranteed to produce synergistic toxicity.
Through it all, Burzynski collects huge fees for his “services,” motivating the desperate families of dying cancer patients to hold massive fundraisers. This sort of story has become a depressingly common topic for this blog over the last year since I really started to notice Burzynski and his followers in a big way. Most recently it was Rachael Mackey and Amelia Saunders. Before that, it was a parade of children and adults that included Brynlin Sanders, Jesse Bessant, Shana Pulkinen, Billie Bainbridge, Kelli Richmond, and Olivia Bianco. There are more, so many more, but they all share two things in common. First, Stanislaw Burzynski failed them, and, second, they made the news because they held fundraisers to try to pay the tens and hundreds of thousands of dollars that Burzynski charges for his services. Meanwhile, although Burzynski somehow has a phase 3 clinical trial that was apparently approved by the FDA (although it hasn’t accrued a single patient in nearly two years), the FDA has slapped him down for serious problems with the institutional review board (IRB) that oversees his “clinical trials” and for making claims for his antineoplastons even though they are not FDA-approved.
Unfortunately, as I noted last week, although the Texas Medical Board (TMB) brought action against Burzynski to strip him of his medical license, it appears that he he will slither away yet again, given that the proceedings against him have apparently been dismissed. At the time I took note of this development, I didn’t know how Burzynski had managed to slither away from accountability for his actions and justice yet again. Certainly, the gloating by the likes of Patrick “Tim” Bolen shed no light on the question, nor did this triumphant screed by someone who calls herself Sarah the Healthy Economist:
Why has Dr. Burzynski been so relentlessly persecuted first by the United States Government and then the Texas Medical Board for so many years?
Follow the money my friends!
The multi-agent gene targeted therapy called Antineoplastons is a nothing short of a huge medical breakthrough that promises to completely shatter the cut, poison, burn Standard Of Care – surgery, chemotherapy and radiation treatment. When clinical trials are completed and Antineoplastons approved, it will be the first time in history that a single individual and not a pharmaceutical company holds the exclusive patent to manufacture and distribute these gene targeted medicines on the open market.
Uh, no. Antineoplastons don’t represent “multi-agent gene targeted therapy.” The person who wrote this bit of gloating is clearly too ignorant of what Burzynski actually does and claims to know that the “gene-targeted” therapy he claims to provide is not antineoplastons (although Burzynski somehow manages always to include antineoplastons in his concoctions). Nor is what Burzynski does anything that will “completely shatter” the current cancer treatment paradigm.
None of this stops the hyperbole, though:
Parents have particular reason to rejoice that the case against Dr. Burzynski has been dismissed. One form of childhood cancer – diffuse, intrinsic, childhood brainstem glioma for which conventional medicine has no cure has been cured by Antineoplastons (with dozens of others). [ANP - PubMed 2003] [ANP - PubMed 2006] [ANP - Cancer Therapy 2007] [Rad & other - PubMed 2008] [Chemo/Rad - PubMed 2005]
Congratulations Dr. Burzynski on this huge win against the foes that are attempting to silence you and stop your amazing work. The road ahead is still long until treatment with Antineoplastons is widely available to all Americans, but this recent victory brings a big one home for the little guy!
No, it’s not. It is, unfortunately, a victory for a man who uses the desperation of dying cancer patients to extract huge sums of money from them or, as one of his patients put it, to use them “as an ATM” and coercing her into buying her prescriptions from a Burzynski-owned pharmacy at “outrageous” prices. Meanwhile, the heart of the case brought against Burzynski brought by the TMB was his off-label use of targeted therapies in treating cancer patients. When I last reviewed this, I was astounded at the number of targeted drugs in the drug cocktails used. Not only was Burzynski using chemotherapy and a lot of it, but he was using some very expensive products of big pharma in a medically unsupportable manner. So let’s head over to the actual legal rulings. I do this, of course, with a bit of trepidation because, of course, I’m not a lawyer. However, even not being a lawyer, I think the reasons for the dismissal become fairly obvious by reading some of the motions and rulings. Plus I had input from a real lawyer.
So why was Buryznski’s case dismissed? Fortunately, some of my readers helped me out in the comments of my last post. You, too, can get these PDFs if you wish, just by going to the Texas State Office of Administrative Hearings (SOAH) and, using a guest account, searching for docket 503-11-1669. The “money filings” are ORDER NO. 12 – RULING ON RESPONDENTS MOTION FOR DISPOSITION, STAFFS SPECIAL EXCEPTIONS, AND MEMORIALIZING PARTIES STIPULATION OF FACTS and ORDER N O. 16 » GRANTING AND DENYING IN PART STAFFS MOTION FOR RECONSIDERTION OF ORDER NO. 12. Basically, the TMB had gone after Burzynski based on the doctrine of vicarious liability, which means in essence that the TMB was arguing that Burzynski was responsible for the actions of the physicians working for him who had cared for the patients at the heart of the TMB case against Burzynski. In response, Burzynski moved to dismiss and/or strike TMB allegations against him to the extent that the allegations were based on the actions of other physicians working at his clinic. His attorney’s argument was that, under administrative law, there is no vicarious liability for the actions of others. This is apparently different from tort law (for example, medical malpractice), where the physician can be held liable for the actions fo physicians working under his control or supervision in some circumstances. The bottom line is that the administrative judge ruled in Burzynski’s favor. From the RESPONDENT’S REPLY TO THE BOARD STAFF’S SUPPLEMENTAL RESPONSE ON THE CONSOLIDATE MOTION FOR DISMISSAL AND SUMMARY DISPOSITION:
Respondent’s ownership of the clinic and his self-designation as the clinic’s chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in “charge of treatment” (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.
The judge accepted this reasoning, which meant that the TMB faced the bad option of trying to prosecute a case based only on what the complaint alleged that Burzynski himself did. It’s not clear why the TMB voluntarily dismissed the case after this ruling, but perhaps the TMB’s lawyers concluded that there wasn’t a strong enough case based only on the allegations against only Burzynski. Basically, by throwing his fellow physicians working for him under the bus, Burzynski walks. Why do I say “throwing them under the bus”? Simple. The TMB could, if it so desired, begin actions against the individual physicians who took care of these patients, and I sincerely hope that the TMB does just that.
As for the significance of the ruling, contrary to what Burzynski’s apologists would like you to believe, this ruling says absolutely nothing about whether what Burzynski is doing is good science or not. It says exactly nothing about whether what Burzynski is doing is good medicine or not. It says even less about whether Burzynski’s clinical trials are ethical or not. All the board found was that, as a matter of law, the TMB couldn’t bring action against Burzynski on the basis of actions performed by doctors under his supervision. So when someone like Patrick “Tim” Bolen exults that Burzynski’s somehow been vindicated, Sarah the Healthy Economist says “alternative cancer treatment wins big,” or Burzynski’s lawyer Richard Jaffe says something like, “The cutting-edge, multi-agent gene targeted therapy devised by Dr. Burzynski which was at the heart of this proceeding is still being given at the clinic and is helping countless patients,” it’s a non sequitur. Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski’s work, nor does it in any way vindicate him. He got off on a technicality, and that’s all.
That still leaves the claim by Jaffe that “two medical board informal settlement panels found that the use of these combination drugs on the advanced cancer patients involved was within the standard of care.” Unfortunately, we have no way of finding out what the settlement panels did or didn’t find because the proceedings of such panels are confidential, being as the name implies an attempt to see if the parties can settle the case prior to litigation. One notes that the board appears to have disagreed with Burzynski’s characterization of the settlement proceedings.
I’m not going to lie or downplay it here. The dismissal of the TMB action against Burzynski is a major setback to efforts to stop what Burzynski is doing. He’s now basically free to continue to do what he’s been doing for the last thirty years. Once burned, it’s unlikely that the TMB will take another crack at him any time soon. The last time it did was back in the 1990s. Will it be in the 2020s before a future board decides to try again, or will Burzynski retire or die before then, leaving his son Greg to carry on the family business?