The Texas Medical Board Puts Stanislaw Burzynski on Probation

Stanislaw Burzynski is a medical doctor in Texas that has promoted untested treatments for severe cases of cancer for decades and likely exploited hundreds of patients with terminal disease for large sums of money. After having escaped from the grasp of regulatory agencies several times, he faced increasing pressure from the Texas Medical Board during the last few years.

Now, a final order has been issued by the Board. His license is revoked due to multiple violations, but it is a stayed sentence while he is on probation. Unfortunately, the Board threw out several key charges that were leveled at Burzynski. At any rate, he is required to submit to monitoring for a substantial amount of time, ordered to pay administrative penalties and restitution as well as to take ethics courses, medical education and pass a crucial medical exam. Although his medical license is not gone yet, all he needs to do is screw up one more time and it might just be gone for good. However, if there is something we have learned from the Burzynski circus it is that he has an incredible ability to slip away from regulators.

Who is Stanislaw Burzynski?

Burzynski got his medical degree and a biochemistry PhD in the late 1960s in Poland and received a Texas medical license from the Texas Medical board in the early 1970s. After spending a few years doing cancer research, he opened the Burzynski Clinic in the late 1970s. In this private medical practice, he treated cancer patients for almost half a century without being a board-certified oncologist. During the decades since he first started the Burzynski Clinic, Burzynski has been involved in a large number of different improprieties. These are discussed in detail here, here, here, here, here, here, here, here and in many other places.

One of his earliest fake treatment for cancer was antineoplastons (ANPs). Detailed investigations into his operation showed that he was really just giving patients sodium phenylbutyrate and asserted that the breakdown products from it would be effective against cancer, despite the fact that there is no convincing evidence that this is true. To cover up this weakness, Burzynski labeled it with the science-sounding language of “personalized gene-targeted” treatment for cancer.

Burzynski has over the years exploited many vulnerable people with severe cancer to come get his alleged “treatments” and cashed in hundreds of thousands of dollars on it. Despite having almost no published data to back up his claims, Burzynski has over 70 clinical trials in progress (which is actually a cover so that he can give highly experimental treatments to people). Some of these were supervised by an Institutional Review Board that was chaired by a friend and associate of Burzynski. It is claimed to be independent, but this gives it a massive conflict of interest. The only paper that Burzynski has published from his clinical trials is a paper about a phase II trials where he intentionally withheld data for over half of all participants. By the way, the study also had no control group. That should give readers an idea of its methodological quality.

Many patients treated by Burzynski has died under circumstances that could be linked to his treatments and regulatory authorities have tried to shut him down repeatedly since the 1970s without luck. As the decades have gone by, he has racked up many violations and medical errors. After several years in the making, the Texas Medical Board has now reached a final verdict on their investigation. It can be found in full here, with a cached version that can be found here.

What did the Texas Medical Board investigation find?

They threw out a lot of the charges against Burzynski and concluded, among others, that (1) there is “insufficient evidence to establish that Respondent used advertising statements that were false, misleading, or deceptive”, (2) “there is insufficient evidence that any of Respondent‘s patients suffered actual harm to their health by a violation of the standard of care or having inadequate records.” and that (3) Burzynski “did not treat patients with ANP in violation of the laws in effect during the relevant time period and did not make false advertisements about ANP during the relevant time period”.

However, they found him guilty on several points:

– “failing to document the risk factors of, or explain the deviation from, the prescribed treatment plan”
– “failing to […] give Patient E the opportunity to give his informed consent to the simultaneous use of two specific drugs,”
– “failing to supervise RAs Rakhmanov, Tikhomirova, and Acelar to ensure that they did not represent to the public that they were authorized to practice medicine”
– “aiding and abetting RA Acelar in the unlicensed practice of medicine,”
– “failing to give Patients A through C and E through G a more specific informed consent form regarding the treatment plan to review and sign”
– “failing to timely obtain informed consent for Avastin from Patients B and F”
– “failing to disclose his ownership interest in Southern Family Pharmacy, which was located in the Clinic building, to his patients”
– “failing to maintain adequate medical records to support charges to Patients B, C, and E”
– “failing to maintain adequate medical records to support charges to Patient G”
– “inaccurately reporting Patient Q’s tumor measurements, causing the classification of the tumor‘s response to treatment to be in error,”

What were the consequences for Burzynski?

The Board ordered Burzynski’s Texas medical license to be revoked. However, this was stayed and he got probation for 16 monitoring cycles. This means that he will be closely monitored by having the medical records of many of his patients reviewed, send in robust informed consent documents to the Board for approval and then use this with all of his patients send in an ownership interest disclosure that will also be presented to patients.

Burzynski was also ordered to complete a course in ethics at the Colorado Physicians Education Program within one year as well as complete at least 44 hours of continuing medical education (CME) on issues such as informed consent, medical record keeping, risk management, supervision and delegation and patient communication. He must also pass the Medical Jurisprudence Examination that is given by the Board.

As far as economy goes, the order compels him to pay 360 000 USD as an administrative penalty and 20 125 USD in restitution. Finally, he must give this order to any health care entity that he works with or for and must prove that he delivered this to them.

If Burzynski screws up during the 16 monitoring cycles, his Texas medical license is almost certainly gone. Considering his past endeavors, it is unlikely that he will avoid making errors. However, we must remember that Burzynski has been able to avoid getting shut down for several decades. He might just be able to slither away one more time…

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