Dr. Stanislaw Burzynski awaits the decision of the TMB regarding his medical license.
I’ve been blogging here fairly regularly about Houston cancer quack Dr. Stanislaw Burzynski since 2011, and now the story is over…sort of. Unfortunately, as you will see, the ending is not satisfactory. It is, however, somewhat better than I had feared it would be. What I’m referring to, of course, is the final ruling of the Texas Medical Board (TMB) regarding Dr. Burzynski, the Houston cancer doctor who has been a frequent topic of this blog because of his practices of charging desperate cancer patient tens (or even hundreds) of thousands of dollars for his “antineoplastons” (ANPs) and, later, what he refers to as “personalized, gene-targeted cancer therapy” (or, as I like to call it, making it up as you go along). Over the course of the last several years, a credulous filmmaker by the name of Eric Merola contributed to Burzynski’s reputation in the alternative medicine world as a “brave maverick doctor” with two blatantly deceptive “documentaries”, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part 2, or, as I like to call it, Burzynski 2: Electric Boogaloo.
Burzynski’s is a long and tangled story, one that I’ve blogged about many times. The details up to early 2014 are covered in an article I wrote for Skeptical Inquirer entitled “Stanislaw Burzynski: Four Decades of an Unproven Cancer Cure.” Burzynski has been selling cancer quackery since roughly 1977, which is around the time he left Baylor University to set up his own private practice and manufacturing facility to make and administer his ANPs for big bucks to desperate cancer patients, many of whom had terminal brain cancers like glioblastomas. The TMB and then, beginning in the 1990s, the FDA have been trying to shut him down ever since, all with only temporary success, as when the FDA managed to put a partial clinical hold on Burzynski’s clinical trials in 2013. It was initially issued for children but then extended to adults and was based on the death of a six-year-old boy named Josia Cotto the year before, of hypernatremia (too much sodium in the blood, a known complication of ANPs delivered at the doses Burzynski uses). The success was short-lived, as the partial clinical hold was lifted a year later, because, according to the FDA, the Burzynski Clinic answered all its questions and concerns.
Most recently, in 2014 the TMB, after a long investigation, decided once again to initiate legal action to strip Burzynski of his medical license. (It had tried and failed back in the 1980s and 1990s to do just that.) Unfortunately, the final ruling came in on Friday, and Burzynski was put on probation. He still has his medical license. Yes, there are conditions and TMB oversight that he’ll have to abide by, and yes, he was fined $60,000, but I view the sanctions as not a lot more than a slap on the wrist. Once again, the TMB has failed to shut Burzynski down. Before I discuss the latest ruling, let me step back a moment, for the benefit of those unfamiliar with Burzynski and those who might not remember enough to put this ruling into context, and provide a bit of background about why I consider him a cancer quack and how he’s shown the inadequacy of the TMB and the FDA in dealing with such brazenness.
Stanislaw Burzynski: The early years
On the surface, it’s easy to mistake Stanislaw Burzynski’s story for that of a classic riches-to-rags-to-riches story. Born in 1943 in Lublin, Poland, just as the Holocaust in Poland was entering its most deadly phase, Burzynski was fortunate enough to have been born to a mother whose family was wealthy and was therefore mostly sheltered from the horror of Nazi-occupied Poland. Of course, he wasn’t even two and a half yet by the time the Third Reich fell, but that occupation was soon replaced with another one almost as bad and much more enduring, that of the Soviet Union. After the war, when Burzynski was five, his older brother Zygmunt was killed fighting the newly installed Communist regime, which affected him his whole life. Basically, he idolized the idea of fighting authority.
Very little is known about the next couple of decades, other than that Burzynski was a good student, and that he got into medical school. By 1970, he was a promising researcher and was recruited by the Polish Communist Party. He refused to join, and in retaliation the Party saw to it that he was drafted into the Polish Army. So Burzynski fled to the US “with only $20” in his pocket in 1970 to stay with an uncle. He soon found a research position in the Department of Anesthesia at the Baylor College of Medicine in a laboratory headed by Georges Ungar, a Hungarian refugee with whom he immediately hit it off. Ungar was famous at the time for proposing that memory resided in peptides in the brain and for his experiments to “transfer” memory by transferring the putative “memory” peptides from one mouse brain to another. It was a hypothesis that seemed to be supported by his experiments but soon faded from favor. At Baylor, Burzynski split his time between working on Ungar’s projects and studying his antineoplastons. He appeared to be well on his way to becoming a successful cancer researcher, securing an NIH grant in 1974 and publishing several peer-reviewed papers.
Basing his concept on cybernetic systems and information theory, Burzynski hypothesized the existence of ANPs as the mediator or regulator of information exchange in autonomous systems that carried information about differentiation to the cells and began to look for peptides in the blood of cancer patients that might correct the abnormal differentiation of cancer. I don’t need to go into detail here about the whole story. However, if you’re so disposed, you can delve into the details in my SI article, a famous The Cancer Letter article, and the NIH website. In brief, based on his hypothesis, Burzynski used gel filtration of blood and urine fractions and tested them for activity against cancer cells. Although there were many fractions initially, these days “antineoplastons” generally refer to AS-2.1 (also known as Astugenal or Fengenal) and A-10 (also known as Atengenal or Cengenal). Basically, AS-2.1 is the sodium salt of phenylacetic acid (PA), a potentially toxic chemical produced by normal metabolism and detoxified in the liver to phenylacetylglutamine (PAG). To boil ANP chemistry down to its essence, AS-2.1 is primarily a mixture of PA and PAG, and AS-10 is primarily PA. Of note, PA had been studied as a potential anticancer agent years before Burzynski discovered it and, although it has been studied intermittently for fifty years, it has shown little promise against brain tumors. More recently, Burzynski has hijacked an orphan drug for urea cycle disorders, sodium phenylbutyrate, because it is a prodrug that is metabolized into PA.
In 1976, though, when he wanted to begin his clinical trials, his ANPs weren’t even fully chemically characterized, and only one of them had been tested in mice. It didn’t work, but Burzynski excused that failure by saying that ANPs were species-specific. Earlier, in 1973, Burzynski had gotten his Texas medical license. Even though he had not done a fellowship in oncology or even a residency in any medical specialty, by 1976 he thought himself uniquely qualified to do a clinical trial of ANPs. Again, all the details are discussed elsewhere, but Burzynski managed to do a case series, although it’s not clear if it ever had ethical approval, and, when the Baylor ethics board refused to approve a clinical trial, managed to get a nearby hospital to approve it. Ultimately, he left Baylor and formed his own practice, to administer ANPs to patients, setting up his own manufacturing facility, first to isolate the peptides from gallons of urine and then to synthesize them once their chemical identities had been worked out.
As I’ve recounted before, from the late 1970s to 1998, Burzynski was under nearly constant investigation by medical authorities, beginning with the Harris County Medical Society in 1979 and continuing with the TMB and the FDA. Indeed, before this most recent ruling, the TMB has tried to strip Burzynski of his license to practice twice, failing to do so in 1993 and 2012. The latter time, Burzynski got off on a technicality.
Why I view Burzynski as a cancer quack
It is my educated opinion that Burzynski is a cancer quack. I do not make that charge lightly and will back up my opinion. Beginning in the late 1970s, he began administering ANPs to cancer patients without their having been demonstrated to be safe and effective in well-designed clinical trials. The “brave maverick doctor” that he is, he just knew they worked, and, like many cancer quacks, over the years he accumulated what seemed like “success stories.” However, as I’ve discussed many times over the last 6 years, if you look at them more closely, these “success stories” can almost always be explained by the conventional treatment patients have undergone before they turned to Burzynski. Examples abound, patients such as Hannah Bradley, Laura Hymas, Tori Moreno, and Mary Jo Siegel, and Sheila Herron. I note that, of these, Laura Hymas featured prominently as a success story, only to die of recurrent cancer a year after the second Burzynski movie featured her so prominently. Particularly memorable was a scene in which audio was played of her and her family trying to persuade her NHS oncologist to do routine tests as part of Burzynski’s clinical trial and him trying to explain to her that he can’t do that because his was an unapproved treatment and his clinical trial was not approved by the NHS. As a fellow physician, I really felt for that oncologist, who was put in a very difficult position. These are but a few of the patients. Fellow skeptic Bob Blaskiewicz maintains a blog, The Other Burzynski Patient Group, patterned on a website set up by Burzynski patients to tout the “success stories,” that documents just how many of these patients have died.
More importantly, the website documents the suffering, both physical and financial, of patients who are lured to the Burzynski Clinic by promises of cures, most often promoted by Burzynski believers like Eric Merola. (Indeed, his Burzynski movies have probably generated more business for the Burzynski Clinic than anything else in Burzynski’s 40 year history.) Basically, Burzynski charges exorbitant fees for his services. He likes to claim that he charges nothing for his ANPs, and, after the FDA cracked down on him, that was true. However, he charges huge “case management” fees. For example, Pete Cohen, Hannah Bradley’s husband, documented why his fundraising target to get his then-fiancée treated in Houston was £200,000 (approximately $246,000 at yesterday’s exchange rate, a lot more back in 2012), estimating her monthly costs to be £8,600. Moreover, £200,000 wasn’t even that high for a Burzynski patient. The prodigious fundraising required to afford Burzynski’s treatments has been documented at TOBPG and all over the blogosphere and includes cases such as that of Seán Ó’Laighin (who did not survive), Rene Louis, Jesse Bessant, Rachel Mackey, Luna Petagine, Wayne Merritt. and Chiane Cloete. A lot of these people came from the UK, and perhaps the most famous two included Billie Bainbridge, whose family raised hundreds of thousands of pounds and got celebrities to help in order to travel to Houston, and Amelia Saunders, a lovely child who was unfortunate enough to be diagnosed with a brain tumor whose parents raised over £200,000 in 12 weeks in order to pay for Burzynski’s treatments and who was featured as a great “success story” by Merola and Burzynski. What really angered me (even more than a typical Burzynski story) is that Burzynski told the father that the formation of cysts in the tumor was the tumor dying because of treatment when in reality it is quite common for tumors to outgrow their blood supply, leading to the death of cancer cells in the middle. Sadly, Amelia also ultimately died.
Here’s where Burzynski is different—and worse—than typical cancer quacks, such as those in Tijuana. Basically, unlike the vast majority of other cancer quacks, Burzynski has had clinical trials open, lots and lots of them, and he has used them as a tool to continue to be able to administer ANPs. Worse, he charges patients enrolled in his clinical trials, a practice that is very much frowned upon and considered, with very few, defined exceptions, to be unethical.
Here’s how he pulled it off. It was the prosecution brought against Burzynski by the FDA during the 1990s that spawned the oft-touted “six dozen” clinical trials. In the fall of 1995, a grand jury indicted Burzynski for seventy-five counts of insurance fraud and violations of the Food, Drug, and Cosmetics Act. As part of this process, Judge Simeon Lake of the U.S. District Court for the Southern District of Texas, ruled that Burzynski’s “continued pretrial release” was contingent upon his administering his drugs exclusively through FDA-approved clinical trials. During the trial in the 1990s, Burzynski’s PR defense against prosecution established and has remained constant ever since. When threatened, he rallies his patients around him to accuse whatever regulatory agency is pursuing Burzynski this time of cruelty and wanting to let them (or their family members die). More recently, thanks to his newfound fame after Merola’s movies, he’s taken to dispatching celebrities like Suzanne Somers, Fabio Lanza (whose sister suffered from end stage ovarian cancer), and Sammy Hagar (whose drummer’s wife suffered from a terminal brain tumor) to defend him. He’s also cultivated powerful political allies, such as Representative Joe Barton (R-Texas), who held a series of hearings featuring cancer patients who were, quite understandably, terrified that Burzynski would be convicted. (Remember, these patients were completely convinced that Burzynski was the only person who could save them.) He also used to routinely drag the FDA Commissioner in front of his committee to castigate him for “persecuting” Burzynski.
As a result, the FDA entered negotiations to let Burzynski set up clinical trials, and Burzynski’s then-lawyer Richard A. Jaffe decided to take advantage of Judge Simeone’s ruling and the political pressure on the FDA, saying, in essence, “If the judge wants clinical trials, we’ll give him clinical trials.” So that’s just what they did. Prosecutors pleaded with the FDA not to give in because it would undermine their case, but the FDA overruled them. First, patients already being treated were enrolled in a wastebasket trial known as “CAN-1”, a retrospective trial looking at all patients then being treated at the Burzynski Clinic. Of this trial, Jaffe (2008) wrote:
. . . As far as clinical trials go, it [CAN-1] was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease. The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.
I always repeat these quotes by Jaffe because they demonstrate the cynicism behind Burzynski’s actions. It gets worse, though. The FDA also permitted Burzynski to set up nearly identical phase 2 trials for every cancer that he wanted to treat. Burzynski claimed these were based on a protocol used in a trial done by the National Cancer Institute in the early 1990s when the NCI had tried to work with Burzynski. (This effort failed because of strife between the NCI and Burzynski, who viewed the NCI as trying to sabotage the trial. These trials had but one purpose, to allow Burzynski to continue treating patients with ANPs, as Jaffe himself boasted (2008):
CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future.
The prosecution was undermined, and the first trial ended in a hung jury in 1997. A second trial on a subset of the original charges resulted in Burzynski’s acquittal. Since then, Burzynski has practiced (mostly) untroubled by the FDA, other than intermittent inspections and warning letters. The TMB tried to take away his license in 2012 and failed on the slimmest of technicalities. Basically, the TMB went 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 actually cared for the patients at the heart of the TMB’s 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 of physicians working under his control or supervision in some circumstances. The bottom line is that the administrative judge ruled in Burzynski’s favor. Basically, by throwing his fellow physicians working for him under the bus, Burzynski walked. Meanwhile, since 1998 he’s been enrolling patients on clinical trials, charging them, and not publishing his full results for a long time. Recently, he has published a few reports, but they’ve all been in bottom-feeding journals and/or don’t report the whole trial. The closest thing he had to a decent publication showed that ANPs didn’t work against colorectal cancer metastatic to the liver. He even just did it again last month.
Then, in 2014 the TMB decided to try again.
The Texas Medical Board vs. Stanislaw Burzynski, Round ∞: The charges
In the summer of 2014, I learned through readers that the TMB was gearing up to take another go at Burzynski. I was surprised and cheered that the Board would be willing to try again so soon after its last defeat, but I remained pessimistic that anything would actually happen. The original complaint was over 200 pages long, but basically the TMB charges fell into three main categories:
- Creating a “medical practice model based on marketing his proprietary anti-cancer drugs to patients without adequate measures for safety and therapeutic value.”
- Misleading patients knowingly “by promoting these drugs as an attraction to bring patients to his medical practice when he was aware that he could not legally include most of those patients in FDA-approved Phase 2 clinical trials of his proprietary anti-cancer drugs” and “into paying funds as a retainer prior to receiving any evaluation, diagnosis or treatment.”
- Misleading patients into: “(1) paying exorbitant charges for drugs and medical services; (2) accepting care from unlicensed persons while Respondent and Respondent’s employees misrepresented those unlicensed persons to be licensed medical doctors in Texas and the United States of America; and (3) accepting care from health care providers who had little advanced education or training related to cancer treatment while Respondent and Respondent’s employees misrepresented those health care providers to be doctors with significant advanced education or training related to cancer treatment.
Anyone who has paid attention to Burzynski should be able to tell that charges #1 and #3 are very provable. As for Charge #2, as I’ve discussed before, the Burzynski Clinic’s trials were on partial clinical hold, Burzynski did appear to be doing a “bait and switch,” where ANPs drew the patients in, and then he’d give them his jury-rigged “gene-targeted personalized” therapy consisting of cocktails of very expensive targeted therapies that were not known to be safe and effective when administered together. To prove these charges, the TMB described 12 patients (labeled Patients A through L) whose treatment did not live up to the standard of care in one or more of these three areas. For instance, the TMB charged that Burzynski treated Patient A with ANPs for colon cancer even though the patient had never had a biopsy and that non-physicians represented themselves as physicians to them. For Patient C it was a similar story; Burzynski treated the patient for mesothelioma without biopsy confirmation and without “adequately documenting Respondent’s medical rationale.” Patient G, for example, was charged for her treatment even though she was on a clinical trial, and there were multiple failures to follow FDA regulations about human subjects.
The Texas Medical Board vs. Stanislaw Burzynski, Round ∞: The proceedings
The TMB proceedings have been going on against Burzynski for well over three years now, and during that time, Burzynski has been pulling out all the stops and using all the old propaganda tactics he’s used since his patients swarmed the courthouse during his trial in the 1990s. Sadly, he’s even had some success in that journalists who should know better fell for the “false balance” trope over a patient who was being denied ANPs because an FDA inspection of his manufacturing facility had turned up serious issues. That the proceedings have dragged on this long shouldn’t be a surprise; Burzynski is an old master at this, as was his lawyer Richard Jaffe. Of course, the amusing thing is that during the proceedings Jaffe actually withdrew as Burzynski’s attorney (and his son Greg Burzynski’s attorney) and apparently sued him for $250,000 in unpaid legal bills, further delaying the proceedings. Then, in December 2015, Burzynski informed the Board that he had had a heart attack and wouldn’t be able to proceed for a time, delaying the second phase of the proceedings for several months.
Then, in October 2016, there was a major setback when administrative law judges issued a proposed decision dismissing the bulk of the charges against Burzynski, largely because of gross incompetence on the part of the TMB. For example, instead of local cancer experts from, for example, M.D. Anderson and Texas Children’s Hospital, you know, the doctors who have to clean up the mess when one of Burzynski’s patients suffers the complications of his incompetence and the toxicity of his ANPs, the TMB relied on outside experts. In fairness, we can’t know for sure why the TMB didn’t use local experts because its spokesperson wouldn’t say. Given Burzynski’s famously litigious nature and his tendency to use his patients as shields and spears against his enemies, it could well be that local oncologists were cowed and didn’t want to speak out the way Dr. Jeanine Graf, director of the pediatric intensive care unit (PICU) at Texas Children’s Hospital did to the producers of the BBC news magazine Panorama when Panorama did a story about Burzynski, stating ,point blank, that she’s never seen a Burzynski patient survive.
Here’s what we got instead:
What we got, instead, was Dr. Cynthia Wetmore, who seems to have done a decent job in most aspects, but screwed up royally when it came to someone referred to as “Patient D.” The judges noted that Wetmore claimed that Patient D “did not receive the standard of care and was exposed to medications that are not documented to cross the blood brain barrier.”
The only problem with that, per the judges, was that “contrary to Dr. Wetmore’s testimony and report, Patient D received no treatment or therapy at the Clinic.” They wrote that “such inattentiveness to the accuracy of her report raises concerns about her credibility.”
This is one thing that utterly infuriated me. Burzynski is an old hand at this. He’s been slithering away from judgments by the TMB and FDA since the late 1970s. You cannot take him down with such inattention to detail. You have to have all your ducks lined up in the proverbial row. Your case has to be airtight and rock solid. On the other hand, the Chief Administrative Law Judge Lesli G. Ginn was not without fault, because she also accepted a lot of Burzynski propaganda as well. For instance, I’ve written many times how the Burzynski Institutional Review Board (IRB), the committee that is responsible for protecting human subjects and examining the ethics of any proposed clinical trial being carried out by an institution receiving funding from the federal government or any company or entity doing the clinical trial to gain FDA approval for a treatment or drug, is hopelessly compromised and packed with Burzynski cronies. Yet Ginn wrote, apparently with a straight face:
Dr. Burzynski testified that IRB was also created in 1983, but it is a separate entity from BRI. IRB was created to supervise the ethical conduct of clinical studies by approving or disapproving clinical trial protocols; to collect data on the toxicity and the response of the investigational agent; and to evaluate data on the efficacy of the investigational agent ANP.22 IRB is not in the business of practicing medicine.23 Neither Dr. Burzynski nor any of the Clinic’s employees is a member of IRB. The IRB consists of 14 members. Carlton Hazelwood, M.D., a retired professor of pediatrics and physiology at the Baylor College of Medicine, is IRB’s chairman.24 Dr. Burzynski testified that he had no role in the selecting the board members.25
Wrong. Carlton Hazlewood is on the board of directors of the Burzynski Research Institute, as has been pointed out many times.
So things looked bad in October, but fortunately this was only a proposed judgment. What did the final judgment say?
The Texas Medical Board vs. Stanislaw Burzynski, Round ∞: The Ruling
On February 15, the TMB issued a proposed decision in which Burzynski would be fined $360,000, required to pay $20,000 restitution to a patient. Unfortunately, although the proposed decision included the revocation of Burzynski’s medical license, the revocation was stayed, with Burzynski to be placed on probation with a public reprimand. In addition to the fine and his probation with reprimand, the TMB would require that Burzynski meet these conditions:
- The billing practices of the Burzynski Clinic must be monitored and patient records reviewed.
- Burzynski must complete a Physicians Ethics program and undergo continuing education to obtain credits of completion in several topics of medical research. (I laughed at this one. Burzynski knows medical research regulations; it’s how he’s so good at skirting them.)
- Burzynski must submit his informed consent forms to the Board for review to show that they comply with relevant regulations and laws, and each patient must receive and sign these new forms before treatment.
- Burzynski must inform his patients that he owns the pharmacy requires them to use. Ownership interest disclosure must be submitted to the Board for review.
- Burzynski must pass a Medical Jurisprudence Exam.
Overall, this struck me as a fairly substantial penalty, but far less than he deserves. Worse, Burzynski would have the opportunity to submit a counterproposal, and that’s what resulted in the final decision issued on Friday, which is even less severe:
The board’s staff had originally recommended that Burzynski pay a $360,000 fine and $20,000 in restitution to a patient. They also wanted Burzynski put on probation, with the power to automatically revoke his medical license if he violated the terms.
Instead on Friday, the board opted for a lesser penalty that included a five-year probation with more lenient terms, a public reprimand, more training and oversight, along with $60,000 in fines and restitution.
Burzynski’s attorneys called the decision a win.
“It means that he gets to continue medicine. He gets to continue to save lives,” attorney Gregory Myers said.
That $60,000 includes $40,000 in fines and the aforementioned $20,000 in restitution to a patient. If Burzynski’s attorneys consider this decision a “win,” then for patients it is clearly a loss. Unfortunately, I haven’t been able to find the final final decision yet; so I don’t know exactly how the terms of his probation are more lenient.
Still, even though Burzynski can continue to practice, I have some hope. For one thing, Burzynski is no spring chicken any more. He’s 74, and he had a heart attack a little more than a year ago. The terms of his probation will likely take him through most of the rest of his 70s, and, at his age, can he really stand to practice with even more stringent monitoring? He’s always been stubborn and arrogant, and I can’t picture him tolerating the regular monitoring of his billing practices and patient charts that will occur with much equanimity at all. Will he actually complete courses on Physician Ethics and study for a medical jurisprudence exam”? I’m not sure I can see it happening. Maybe he’ll retire.
Or maybe not. That’s the problem. Burzynski is nothing if not expert at evading the spirit of constraints placed on him to continue to sell his unproven treatments to patients for exorbitant sums of money.
The failure of the FDA and state medical boards to protect the public from quacks
With the election of Donald Trump as President, I and my SBM co-conspirators have been warning about the consequences of the sort of massive deregulation that Trump wants. For instance, just this week, Jann Bellamy warned about efforts to remove impediments to “right-to-try” laws, shield wrongdoers, and hide adverse events, and Steve Novella has warned about Trump’s plan to deregulate pharmaceuticals. Before that I had been beating the drum about how every single candidate for FDA Commissioner under consideration by the Trump administration, such as Peter Thiel Crony Jim O’Neill, and honest-to-goodness pharma shill Scott Gottlieb, favor massively decreasing the amount of evidence for drug approval, when in fact the FDA functions pretty well given its underfunding and an argument can be made that the evidence bar for approval is actually too low.
Contemplating the case of Stanislaw Burzynski worries me. Consider that the FDA using its current guidelines has only been intermittently able to temporarily put a halt to Burzynski’s preying on patients in the name of clinical trials. Meanwhile, state right-to-try laws could be a boon to practitioners like Burzynski, who, indeed, has already taken advantage of the Texas right-to-try law. It’s not just Trump, though. The majority of the states are solidly held by Republicans, and, as I’ve pointed out many times before, state medical boards are generally underfunded and outgunned. That doesn’t even consider the “quack protection” and “quack full employment” laws regularly discussed by Jann Bellamy and others here that would license and protect naturopaths, chiropractors, and other quacks, all in the name of “health freedom,” a recurring theme among Trump’s candidates for FDA commissioner which is used as a justification for “right-to-try” laws.
The failure of the TMB strip Burzynski of his medical license reminds me that, if anything, the laws and regulations protecting the public from quacks are too weak, not too strong. I fear they will become a lot weaker soon.