On November 19, 2015, in Austin, TX, lawyers gave their opening statements in the Texas Medical Board’s (TMB) case against cancer doctor Stanislaw Burzynski. Two years have passed since patient complaints opened this case, the latest in a long series of only occasionally successful attempts to sanction the Houston internist who has boasted of his unorthodox cancer treatments for decades. As many readers will know, Stanislaw Burzynski discovered, developed, prescribed, manufactured, distributed, and profited mightily from the business he built around what he calls “antineoplastons,” amino acids and peptides that are found in human urine and blood. Burzynski contends that cancer patients have lower levels of these compounds in their blood, and he has administered an antineoplaston replacement therapy since the late 1970s. No professional medical organization recognizes antineoplaston deficiency as a risk factor for cancer, and Burzynski had never produced a reputable study that suggests antineoplastons are an effective chemotherapy. In more recent years, Burzynski had taken to prescribing untested low-dose, off-label chemotherapy cocktails (plus a sodium phenylbutrate chaser, which he also manufactured) on the basis of a commercially available gene test, calling it gene-targeted therapy.
A TMB investigation yielded charges against Burzynski, three doctors, and a physician’s assistant at the Burzynski Clinic. In the intervening time, numerous filings at the State Office of Administrative Hearings (SOAH) website have revealed a wide array of charges about financial, medical, and ethical shortcomings alleged to be plaguing the Burzynski Clinic. In the final months leading up to the current hearings, Lee Bukstein, the Board’s lawyer assigned to the Burzynski cases, began to withdraw from the cases of Greg Burzynski, Anita Shrout, Alejandro Marquis, and Zanhua Yi, cases which are not as far along as the one against Stanislaw Burzynski. It seemed like after all that time the lawyer with over a year and a half of experience on this complicated case would be leaving it to new lawyers at the eleventh hour. In June, however, a letter from Bukstein to the presiding judges, Roy Scudday and Catherine Egan, appeared on the SOAH website, which read in part:
After significant discussion with my supervisors about the logistics of transferring responsibility for this case over to another member of Board staff, we have reached a consensus that the most expeditious and efficient plan would be to have me remain on the case through the end of the trial on the merits. […] I will point out that I will only be representing the Board in regard to this captivating case, and no other, after August 31, 2015.
In July, not long after the announcement that Mr. Bukstein was going to be devoting all of his time to this one case, a motion appeared on the SOAH site that was entirely unexpected. It began:
For reasons that should be left unexplained, Respondent’s [Burzynski’s] Counsel hereby moves to withdraw from this case.
Rick Jaffe, the lawyer who had been Burzynski’s wing man and advocate for at least fifteen years, was pulling out of the case. No explanation was given, and following a hearing behind closed doors, an independent administrative law judge determined that Jaffe was required to withdraw given the circumstances. What had happened did not become clear until Jaffe withdrew from another case, that of Greg Burzynski, Stan’s son and heir apparent:
Respondent [Greg] is a vice president and an employed physician at the Burzynski cancer clinic in Houston. The clinic is owned by Respondent’s father, Stanislaw R. Burzynski. Undersigned counsel had represented Stanislaw Burzynski in a related SOAH board case.
Undersigned counsel is taking legal action against Respondent’s employer which might have a material adverse effect on Respondent’s interests as an officer and employed physician at the clinic. As a result of such action, undersigned counsel will likely have a conflict of interest with Respondent, at least until the anticipated legal action is resolved.
In the PACER database, we discovered that Jaffe was not only suing Burzynski for nearly $250,000 in unpaid fees, but was also trying to force Burzynski into chapter 7 bankruptcy to collect. In the TMB case, Burzynski’s new legal team, in a doomed bid for a continuance, suggested that Jaffe may have hurt Burzynski’s case deliberately:
Additionally, Mr. Jaffe has now led suit against Respondent in the Bankruptcy Court in an attempt to force an involuntary bankruptcy for the Respondent. It is Respondent’s belief that Mr. Jaffe has taken actions to undermine Respondent’s position in this case, all of which prejudices Respondent and his ability to properly prepare his defense.
Because Jaffe’s performance was suddenly at issue, Jaffe suggested that Burzynski had waived lawyer/client confidentiality so that he could defend himself. Further, when Burzynski’s list of creditors was presented to the court, Jaffe alleged that Burzynski had not complied with the order because money was owed to insurance companies and to patients, none of whom were listed as creditors. Jaffee and Burzynski have since settled, and it seems we shall never know the names of those alleged creditors.
And so, on November 19, Burzynski, flanked by a new legal team, appeared before judges Scudday and Egan to answer charges by the Texas Medical Board. Mr. Bukstein began with the following opening statement:
Dr. Sidney Farber, after World War II, worked in a basement of Boston’s Children’s Hospital trying to come up with a medicine for children who had leukemia, which was a really horrific death sentence for children. He’s acknowledged and it’s widely undisputed that he is one of the world’s pioneers of cancer chemotherapy. His successes made him one of the most respected members of the medical community and took him from the basement to an office with a grand view of Boston Harbor across the Charles River into Cambridge. Today there are buildings named after Dr. Farber on both sides of the river. The list of Nobel Laureates that came out of Dr. Farber’s cancer research program is long. Despite all the accolades, Dr. Farber was more concerned with his frustration with the apparent resistance of cancer cells to each new medication he found.
His protégés, Dr. Emil Frei and Dr. Emil Freireich, proposed the idea of combination chemotherapy. It was a combination of medical punches to floor the cancer long enough for the immune system to finish it off. Dr. Farber’s overriding concern was protection of the patients from the side effects the toxicity of the ingredients in the cocktail of drugs. This cocktail they came up with was called (BAM), almost insidious, but the two young physicians under Dr. Farber’s supervision insisted that they would do everything possible to protect the patients. Still Dr. Farber initially showed Dr. Frei and Dr. Freireich the door. But ultimately they worked out this fundamental tenet of cancer research. Protect the patient from the disease AND the cure.
The principles that were developed in their combination treatment research became the cornerstone, the standard for cancer research all over the world. These principles for physicians involved in clinical investigations evolved into the study designs, the requirement that biostatistically significant data and appropriate objective analysis to backup conclusions. These principles for physicians involved in clinical investigations evolved into the standards for Phase 1, Phase 2, and Phase 3 trials for innovative treatments. We’ll be talking a lot about Phase 1, Phase 2, and Phase 3 in this trial. Phase 1 a small number of patients to determine the parameters of safety. Phase 2, a larger number of patients to determine whether safety and efficacy support a decision to move on to Phase 3. And finally Phase 3, studies of several hundred, at a minimum, several hundred patients in randomized trials with control groups of patients receiving a standard treatment. The bargain that Dr. Frei and Dr. Freireich struck with Dr. Faber was to engage the discipline of science to objectively pursue data for an objective evaluation while protecting the patients as much as possible.
And this was as a time when all 3 doctors knew that most their patient subjects would suffer from the disease and the treatment and then die. The fundamental principle in their bargain was that the patient with their family would have a choice if they entered into the frontier of cancer research. There was no deception that the choice was between life and death. The choice was between a more comfortable demise or being part of the journey forward toward a cure for tomorrow’s patients, tomorrow’s children. The only thing that made this choice acceptable to Dr. Farber, Dr. Frei, and Dr. Freireich and the medical professional community was the discipline of science, the promise that doctors involved in research would honestly follow the guidelines involved and this is where Dr. Burzynski departed from the promise of the medical professional community a long time ago.
Consistently as will be shown through testimony and documents in this case, Dr. Burzynski has supervised, directed and controlled activities that are clinical research, human experimentation, clinical investigation in such a way as to masquerade as the discipline of science. The care of the patients in this case the conduct of Dr. Burzynski and his clinical studies as both doctor and investigator, the manipulation and influence on the institutional review board that is supposed to be policing him, the publications and reports on his treatment of patients and his misleading promotional marketing statements about his treatment of patients with cancer all represents a breaking of the promise made between Dr. Farber, Dr. Frei and Dr. Freireich. I have lost count of the times that Dr. Burzynski has insisted that he should be awarded the Nobel Prize for his treatment of cancer patients. Scientists do not win the Nobel Prize by cheating their way into it, and it is cheating. The frontier of science is where the medical professional community insists that the real discipline of science be applied at patients.
Dr. Burzynski and his witnesses will describe the frontier of science as the Gold Rush, where anything goes, especially unloading entire arsenals of medications on naive and desperate cancer patients and families almost all in uses of these medications unapproved by the FDA and unproved by the accepted process of Phase 3 study and peer review in the general medical professional community. The frontiers of science are not a wilderness or a wasteland. The discipline of science is not the guile of a gunslinger. No matter how many cancer tumors Dr. Burzynski seems to shrink, or even kill with his magic bullets, Dr. Burzynski and his witnesses will explain how they can observe test tubes and petri dishes full of dead cancer cells and cell cultures and know exactly what happens on a genetic and molecular level inside the body of a living human being, a living cancer patient. They might as well just tell you that he uses magic bullets. Dr. Burzynski and his witnesses will describe the frontier of science as a place where the end justifies the means. The frontiers may be the range of true pioneers such as Dr. Farber, Dr. Frei, and Dr. Freireich, but it is not the Wild West. So Board staff will not be focused on Dr. Burzynski’s magic bullets. Board Staff will be focused on the allegations in the second amended complaint. Those are the facts, along with the supporting facts the Board Staff is required to prove by a preponderance of the evidence, and I’m going to summarize what we are going to talk about.
Bukstein then outlined the main charges against Burzynski by the Board following an investigation into treatment of seven cancer patients (almost all of whom are now dead): 1) that Burzynski violated the standard of care; 2) failed to demonstrate an adequate medical rationale for evaluation, diagnosis, and treatment; and 3) violated standards of adequate documentation. The TMB also alleges that Burzynski’s practice of medicine: 1) constituted inadequate discussion of treatment alternatives; 2) constituted improper charges for care, drugs, medical supplies, and other services; 3) constituted inadequate informed consent; 4) aided and abetted the unlicensed practice of medicine; 5) constituted inadequate direction, supervision, and control of medical care personnel; 6) constituted improper delegation of medical tasks; 7) constituted inadequate disclosure of ownership interest in a facility to which a patient is referred; and 8) violated the ethical and professional responsibilities of clinical investigators.
Today Dr. Fost [a medical ethicist] will explain why Dr. Burzynski’s conduct, practice model, clinical investigation model and public marketing statements are cheating on the discipline of science. Tomorrow Elaine Kloos, the coding and billing expert, will explain how Dr. Burzynski and the employees under his supervision, direction, and control cheated in coding and billing for patients A through G. Monday, Dr. Wetmore will explain the details of how Dr. Burzynski and the employees under his supervision, direction, and control cheated on the standard of care, and how Dr. Burzynski’s conduct, practice model and clinical investigation model, and public marketing statements are cheating. Tuesday Patient F and his wife, and Wednesday Patient A’s wife, will testify how they got cheated by Dr. Burzynski and employees under his supervision, direction, and control.
Remember Dr. Farber who I introduced at the very beginning of the opening. […] Dr. Farber, in his office high above the Boston Children’s Hospital parking lot, […] showed Dr. Frei and Dr. Freireich the door when they first faced his skepticism about protecting patients adequately in the rush to advance cancer treatment. If Dr. Farber had reviewed this contested case, I am confident that he would show Dr. Burzynski’s cheating the window.
I was present only for the first half of the first day, long enough to get a really nasty look from Burzynski and for his wife to mutter something nasty about my appearance as I walked past her. The Medical Board’s experts whose depositions had been entered into evidence were cross examined by the defense team. My impression of the examination of the medical ethicist was that the defense was trying to point out all of the things that the medical ethicist was not an expert in or had not done, while avoiding his area of expertise, ethical trial design, and execution. Whenever the defense inadvertently strayed into one of these areas, it was like they trod on a landmine. The next day, the billing expert similarly defended her expertise exceptionally convincingly, I thought, while drawing attention to the hundreds of thousands of dollars of allegedly improper billing codes in the patient files. The Medical Board rested its case before Thanksgiving, and the hearing will continue between January 19 and 29. A list of names read out at the first half of the hearing suggests that Burzynski intends to parade a number of the same former patients in front of the judges who have testified for him before. The hearings will be open to the public, and skeptics are encouraged to attend.
A number of questions remain. In 2013, following the death of a child from apparent hypernatremia, a known side effect of antineoplastons, FDA inspectors reviewing Burzynski’s numerous clinical trials (which his former lawyer, Rick Jaffe described in his memoir as “[…] an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment”) observed a host of grotesque, unthinkable violations, including “[failing] to comply with protocol requirements related to primary outcome, therapeutic response” (i.e., inflating success rates in two-thirds of the cases reviewed), failure to report adverse events, over a hundred overdoses, that “tumor measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review,” and most chillingly, “There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” The trials were suspended for a long time, however, now there appears to be no resistance from the FDA, as patients with brain tumors are currently travelling to Houston to be given antineoplastons. Skeptics want to know what happened at the FDA that allowed this to occur, and we are soliciting any information that anyone has that could help us understand how in the world this could possibly happen. The FDA is simply not forthcoming with any useful information about this, and so we are seeking to cultivate relationships with knowledgeable experts to enlighten us. As it stands, the only government agency currently protecting patients from Burzynski’s medical adventurism is the Texas Medical Board.
- A pared down video recording of the proceedings was posted by one of Burzynski’s supporters, and is available at: http://www.donotlink.com/hmr1. All quotations from the trial come from an audio recording made at the hearing; any errors may be attributed to faulty transcription.
- The Board’s allegations may be read in their entirety in the Second Amended Compliant at http://wp.me/a2X2Ga-hs.