As feared, Houston cancer quack Stanislaw Burzynski (mostly) slithers away from justice again [Respectful Insolence]

I’ve been blogging 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 far from ideal. It is, however, somewhat better than I had feared it might be. What I’m referring to, of course, is the final ruling of the Texas Medical Board 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 (now updated) 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 desparate cancer patients, many of whom had terminal brain cancers like glioblastomas. The Texas Medical Board and then, beginning in the 1990s, the FDA have been trying to shut him down ever since, all with little or 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 of hypernatremia the year before (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 Texas Medical Board, 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 Texas Medical Board 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 Texas Medical Board has failed to shut Burzynski down.

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 as a success story. 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. It’s not for nothing that I refer to Burzynski’s operation as taking advantage of the kindness of strangers and note how often the press spins a narrative full of false balance of desperate cancer patients desperately pursuing their last chance. 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 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 on clinical trials, a practice that is very much frowned upon and considered, with very few, defined exceptions, to be unethical.

The last time that the TMB tried to take Burzynski’s license away was in 2012. It failed on the slimmest of technicalities. 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 original complaint was over 200 pages long, but basically the TMB charges fell into three main categories:

1. Creating a “medical practice model based on marketing his proprietary anti-cancer drugs to patients without adequate measures for safety and therapeutic value.”
2. 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.”
3. 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 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’s 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.

Also, 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. Instead, we got experts from elsewhere who made some careless mistakes. Worse, the Chief Administrative Law Judge Lesli G. Ginn was not without fault, because she also accepted a lot of Burzynski propaganda as well, in particular Burzynski’s claims that he had an independent Institutional Review Board (IRB). Wrong. The chair of Burzynski’s Institutional Review Board, Carlton Hazlewood, is a longtime Burzynski crony and chairs 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?

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 the TMB monitoring him? 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.