It’s been a while since I wrote about Stanislaw Burzynski, the Polish ex-pat physician who is not an oncologist but treats cancer patients in his Houston clinic with a mixture of a compound he calls “antineoplastons” (ANPs) and “gene-targeted” therapy. The former are really a mixture of various chemicals he isolated from the blood and urine back in the 1970s, including chemicals like phenylacetic acid (PA) and phenylacetyl glutamine (PAG), that he thought to be endogenous cancer suppressors but has never been able to demonstrate that they are, despite having had four decades to do so. Basically, his very best evidence is not very convincing evidence that he does better (or even as well as) the current standard of care. The latter usually consists of a high-priced cocktail of new targeted pharmaceutical agents administered in a “make it up as you go along”-style form of “personalized” or “precision” medicine. It also turns out that PAG and PA are byproducts of the metabolism of a drug called phenylbutyrate (PB), that Burzynski has also been using off-label to treat all kinds of cancers.

What drew my attention to Burzynski again today is news from last week that is not good: A preliminary judgment has been entered in the case the Texas Medical Board brought against him three years ago, and, if this judgment stands, Burzynski will likely get off with at most a slap on the wrist. I’ll discuss that more later, but first a little background for those new to the Burzynski saga, complete with copious links for background on this four decades-old story.

I’ve written about Burzynski many, many times since 2009, but most of that started in 2011, when Burzynski’s flack Marc Stephens threatened UK blogger Rhys Morgan, who was a teenager at the time, with legal action for a blog post on how ANPs don’t work and at the time how Burzynski was attracting British patients with fatal brain cancers to his clinic, where they paid tens or hundreds of thousands of dollars to be treated with what my opinion has evolved since 2011 to consider quackery. It was those threats, and threats against other skeptical bloggers, that drew my attention to Burzynski, where it has remained periodically over the last five years, particularly after Burzynski’s own propagandist, Eric Merola, produced two spectacularly biased movies touting Burzynski as a great man curing cancers that no one else could but being persecuted by the FDA and Texas Medical Board, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part 2.

The bottom line is that, while Burzynski might have been a legitimate researcher in the early 1970s when he worked for Baylor, it's very hard for me not to come to the opinion that, ever since he struck out on his own, he’s been nothing more than a cancer quack charging enormous sums of money for “case management” fees to administer antineoplastons. The FDA, the Texas Medical Board, and other regulatory bodies have tried to shut Burzynski down several times since 1976, and they have in each instance failed. Most recently, the FDA did put a partial clinical hold on his clinical trials after a six year old child named Josia Cotto died of hypernatremia (too much sodium in the blood, a known complication of Burzynski’s “nontoxic” ANPs), but even after that the FDA eventually (and inexplicably) lifted the hold. Those clinical trials, as I’ve documented before, were in reality a ploy by Burzynski, based on the strategy of his lawyer Richard Jaffe’s strategy to bypass a court ruling by having ANPs be administered under the auspices of clinical trials. Unbelievably, the FDA approved these trials, which made a case against Burzynski go away in the 1990s. (Details straight from Jaffe's pen here.) In the wake of the failure of the FDA and the Texas Medical Board to rein in Burzynski’s quackery, patients with terminal illness such as Liza Cozad, McKenzie Lowe, Laura Hymas, Rachael Mackey, Amelia Saunders, and many others remain without justice and will see their numbers continue to grow.

I was actually fairly optimistic and happy about the most recent attempt by the Texas Medical Board to shut down Burzynski. Even though I did at the time call it The Texas Medical Board vs. Stanislaw Burzynski, Round Infinity. As the case dragged on, though, I started to wonder: Will Stanislaw Burzynski finally face real justice? Sadly, if the current proposed ruling stands, the answer will almost certainly be no:

In its failed bid to strip controversial cancer doctor Stanislaw Burzynski of his medical license, the Texas Medical Board has done the unthinkable: It allowed the judges hearing the case to issue a preliminary ruling that would make great ad copy on the Burzynski Clinic's website, right alongside dubious claims and anecdotal success stories related to an unproven "treatment" regimen that began when Burzynski surreptitiously collected urine from public restrooms. Administrative law judges last week issued a proposed decision dismissing the bulk of the board's latest claims against Burzynski, calling the doctor — who is not an oncologist — "a dedicated and innovative physician who wants to continue treating advanced cancer patients." The judges' 221-page decision, which still awaits ratification, is the culmination of a nearly two-year effort by the medical board to prove that Burzynski has swindled patients into paying inflated costs for questionable treatments, by, in some cases, passing off unlicensed staff as doctors.

I haven’t read the entire 221-page decision yet, but I’ve read the conclusions and skimmed a lot of the testimony. (You can read the whole proposal for decision here if you wish.) As I go through it, extra blog posts might become necessary. However, Craig Masilow gives a good summary in his Houston Press article Texas Medical Board Whiffs in Latest Crusade Against Controversial Doc that I just quoted. For instance, there is this epic incompetence. Noting that, 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 isn’t saying. 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. One notes that that same report showed the mother of a Burzynski patient who decompensated and needed to be in the PICU at Texas Children’s complaining about hearing the staff their complaining about how they were “always cleaning up Burzynski’s messes.” You might also remember that r. Graf stated, 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 Texas Medical Board 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 air tight and rock solid. You cannot allow obvious errors like this to creep in to your case, allowing the judge to write:

Staff makes allegations against Respondent ranging from standard of care violations to ethical violations in conducting clinical studies that are regulated by the FDA. Staff relied heavily on the testimony of three experts, one on ethics, one on billing issues, and another regarding the standard of care. The experts’ qualifications will be discussed more fully later, but it is important to know that Staff’s experts had not seen all the relevant records of the patients upon which they were asked to give an opinion. For example, Cynthia Wetmore, M.D., a pediatric oncologist, testified that Respondent had misrepresented Patient D’s tumor response to ANP, when Patient D was not treated at the Clinic. Staff’s reliance on the testimony of these experts cast doubt on the validity of its allegations.

On the other hand, the Chief Administrative Law Judge Lesli G. Ginn is not without fault, because she writes this howler right after the paragraph cited above:

The Board recognizes a patient’s right to seek alternative or non-standard therapy and that physicians may provide such therapy. The alternative therapy provided by Dr. Burzynski during the period at issue has since become more accepted and mainstream. During the hearing, Staff took the position that the applicable standard of care regarding Dr. Burznyski’s treatments was what was in effect at the time he provided the treatment, even if that treatment protocol has since become accepted in the medical community. Such an approach as taken by Staff would appear to discourage innovation in the treatment of advanced cancers.

That is just stupid. Burzynski’s treatment protocols, with ANPs, PB, or his “personalized gene-targeted” therapies, were never standard of care, either at the time of the cases used in the TMB complaint or now. What was Judge Ginn smoking? ANPs are not FDA-approved for anything and therefore cannot be standard of care, even off-label. PB has been tested against some cancers, but there is no good evidence to support the expansive claims that Burzynski makes for PB as an "ANP prodrug." (A prodrug is a drug that itself doesn't produce therapeutic effects but is metabolized into a chemical that does.) Burzynski's version of "personalized gene-targeted therapy" is so incompetently done and wouldn't be standard-of-care yet even if done competently. Yet, Burzynski keeps making the claim that he is a trailblazer in "personalized" or "precision" medicine for cancer and that cancer centers like M.D. Anderson are scrambling to catch up with his brilliance. The hubris continues to amaze.

Ginn 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

Bullshit. Pure bullshit. Carlton Hazlewood is on the board of directors of the Burzynski Research Institute, as I've pointed out many times and has been for many years. Hell, he's still listed there! If you don't believe me, look at this warning letter from the FDA from 2009, which listed an obvious conflict of interest on Hazlewood's part:

For the (b)(4) study, you (IRB Chairman, Carlton F. Hazlewood, Ph.D.) are listed as a clinical investigator on the "Certification: Financial Interests and Arrangements of Clinical Investigators"; you are also listed as being an ex-officio advisor to the (b)(4)/IBR Central Registry Control Committee/Data Monitoring Committee. Therefore, you had a conflict of interest. Minutes of the August 8, 2008 IRB meeting indicate that you attended this meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) to inquire about the status of the animal toxicity studies. According to the minutes, all members were in favor, none were opposed, and none abstained. Minutes of the October 24, 2008 IRB meeting indicate that you attended the meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) informing them that their application was on hold. The vote on this action is recorded as unanimous; therefore, according to the minutes of these two IRB meetings, you participated in the review of this study and voted on it even though you had a conflict of interest. We also note that you signed off on all correspondence sent by the IRB to Dr. (b)(6) and the sponsor in regard to this study.

Basically, Hazlewood chaired meetings about studies for which he was listed as a clinical investigator! I've been harping on this issue time and time again. It's an incredibly obvious COI. Yet, for some reason neither the FDA nor Judge Ginn seems to have noticed or done anything about it. I'm not sure who whiffed here, the TMB for not hammering this point home and not letting Burzynski and Hazlewood get away with legalistic splitting of hairs by saying that Hazlewood doesn't get paid by the Burzynski Research Institute or Judge Ginn. Maybe both whiffed.

Masilow notes that the TMB should have contacted me. I would point out, however, that, as much as I've written about Burzynski, for purposes of the TMB I'm not a neurosurgeon, neurologist, or oncologist. Consequently, I couldn't be an expert for purposes of testimony. Also, as a long time critic of Burzynski, I would also be automatically portrayed as hopelessly biased. Leaving that aside, though, what does the proposal for decision accept?

The categories of complaints were:

(1) Failing to treat Patients A through G according to the generally accepted standard

of care; (2) Engaging in unprofessional and dishonorable conduct that was likely to deceive

the public by: failing to properly supervise unlicensed and unqualified medical

personnel; improperly delegating professional medical responsibility to

unlicensed personnel; and misleading patients about the Clinic’s personnel;

failing to provide adequate written informed consents for patients to review and sign;

failing to disclose his ownership interest in pharmacies and a laboratory; overcharging patients; and

deceptively marketing and advertising the Clinic’s cancer treatments; and (3) Violating ethical and professional responsibilities by: failing to protect patients in clinical trials, specifically Patients G and I through BB;

engaging in unethical treatment of Patients A through F;

treating Patients H through P without proper BRI—IRB approval;

reporting inadequate or inaccurate therapeutic responses for Patients G and Q through BB;

failing to train subordinates adequately about adverse events for Patients G and Q through U;

failing to evaluate and report Patient G’s reactions to corticosteroids and failing to inform her of additional costs imposed by the Clinic;

providing inadequate or inaccurate case history for Patient CC; and

violating federal regulations as the clinical investigator.

Well, for one thing, Judge Ginn appears to have given way too much credence to the list of patients Burzynski had testifying for him if she could write:

The ALJs find that Respondent has been of significant value to the community of terminally ill cancer patients who either rejected conventional treatment or had conventional treatment fail. The ALJs are aware that, as with conventional cancer treatment, not every patient will have a positive response to Respondent’s cancer treatments. But based on the evidence presented, several patients have had positive results from his treatments some of which have become more accepted and mainstream.

Judge Ginn owes me a new keyboard, as I was drinking my coffee when I read that. Basically, I've deconstructed many Burzynski anecdotes, and there's no good evidence that any of the patients who think they were cured by Burzynski were actually cured by Burzynski, and, I repeat, none of Burzynski's "innovative" treatments have become accepted or mainstream. None. Again, what was Judge Ginn smoking here?

So, after nearly three years, here's all that the Administrative Law Judge could issue such a sad ruling, as described by Masilow:

The medical board even seemed to whiff on what should have seemed to be a lock: the clinic's love for draping key staff members in white lab coats, with name tags identifying them as "doctor," who are addressed by other employees as "doctor." In this setting, it's not hard to understand why a patient might assume that these individuals are in fact licensed to practice medicine in the United States. But, as Burzynski's lawyers pointed out, research associates with Ph.D.s are also "doctors," and it certainly ain't the clinic's fault if some dying patient jumps to conclusions. When it came to the board's double-barrel accusation that Burzynski misrepresented these employees as physicians, thereby aiding and abetting the unauthorized practice of medicine, the judges split the difference: in the majority of cases, they opined, Burzynski was guilty of allowing these people to hold themselves out as physicians, but since an actual physician made the important calls, these fake medical doctors weren't actually practicing medicine. In one case, though, a fake doctor actually practiced fake medicine, leaving Burzynski vulnerable. The board can still pursue sanctions, but not until both sides get to submit even more arguments for the judges to consider.

I realize that this is only a proposed judgment. It is not final. Both sides will have the opportunity to dispute Judge Ginn's findings. However, it is indisputably true that Judge Ginn has produced a proposal for decision that contains text that will feature in Burzynski propaganda as complete vindication and allow him to paint the findings for which the TMB might issue sanctions as having been caught on mere technicalities. After all, Ginn found the vast majority of the TMB's allegations to be unsubstantiated. Burzynski was found to deviate from the standard of care for Patient E, mostly by not explaining, but not of the other five patient described; to deviate from informed consent for patients A, B, C, E, F, G, though not horribly; and not to have adequate records for four of the patients; to help one (out of many alleged) unlicensed people practice medicine and a few other small things, such as improperly recording tumor measurements. Worse, the decision also states that he saved lives and helped people, and it's hard not to read it, taken in total (at least as much as I've read) as supporting allowing him to continue to practice to save lives.

It's widely thought that there will be more legal maneuvering and that the TMB will make its final decision at its December meeting. I wouldn't be surprised if this drags on longer, but my hope that the TMB will do anything meaningful to bring to an end what I view as Burzynski's four decade streak of victimizing cancer patients. I once echoed Tamar Wilner in asking how long can Burzynski's “unprecedented medical malfeasance” continue? Unfortunately, the answer seems to be: No time soon.