On March 3, 2017, the Texas Medical Board sanctioned Houston internist Stanislaw Burzynski for over a hundred violations related to his cancer clinic. However, despite these sanctions, Burzynski will be allowed to keep his medical license and continue to practice on patients.
For decades, Burzynski has peddled a chemotherapy he calls “antineoplastons” (ANP) under the auspices of dubious FDA-sanctioned clinical trials (see “Stanislaw Burzynski: Four Decades of an Unproven Cancer Cure” and “Skeptic Activists Fighting for Burzynski Cancer Patients,” SI March/April 2014).
Burzynski sells a chemotherapy of the metabolic derivatives of sodium phenylbutyrate, a urea cycle drug that he also produces at his Houston manufacturing facility. Antineoplastons are typically administered intravenously under clinical trial protocols and frequently under compassionate care exemptions. In recent years, however, Burzynski has taken to selling something he calls “personalized gene targeted therapy,” which is a low-dose chemotherapy cocktail (based on a genetic test) plus sodium phenylbutyrate. The theory behind antineoplaston therapy, according to Burzynski, is that cancer patients have lower levels of these peptides and amino acids in their blood and urine and that replacing them can cure cancer.
This posits both a cause of cancer that no other researcher has identified and an immune mechanism that remains undescribed in the literature. The “personalized gene-targeted therapy” remains unproven and carries the risk of synergistic toxicities. Merely starting these therapies costs patients tens of thousands of dollars, and there is a hefty monthly fee for as long as the patients are treated. Frequently, patients try to raise hundreds of thousands of dollars for Burzynski online because insurance companies generally do not cover his unproven treatments.
Late in 2013, the Texas Medical Board initiated proceedings against Burzynski. The original slate of charges grew to an amended complaint in the summer of 2014 of over 200 pages of accusations related to ethics, standard of care, and billing procedures, and dozens of patients were mentioned. Following discovery and depositions, a hearing on the merits was convened in front of Administrative Law Judges (ALJs) Catherine Egan and Roy Scudday in November 2015. The hearing was scheduled to take place on either side of the Christmas holiday, with the Medical Board’s witnesses’ depositions cross-examined first. Burzynski’s witnesses had to wait until the spring because Burzynski had a heart attack over the holiday and required rehabilitation.
In the proposed decision, the ALJs commented on the complexity of the Burzynski proceedings, which covered the treatment of thirty patients over the course of thirteen years. The Board had submitted medical records from all of those patients, as well as thirty-six depositions in fifty-nine volumes totaling 19,870 pages of exhibits. The first draft of the findings was 221 pages long, three times as long as the Board staff’s closing arguments, which was limited by the judges to a seventy-five-page brief.
In the end, the judges found that the Medical Board was unable to demonstrate that Burzynski had committed most of the charges they had brought against him, including all of the charges related to the standard of care. The judges explained in their proposed findings:
[Medical Board] Staff relied heavily on the testimony of three experts, one on ethics, one on billing issues, and another regarding the standard of care. . . . 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 [Burzynski] 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.
While the testimony of these experts may have been put in doubt, the judges at the State Office of Administrative Hearings, which oversees legal proceedings for Texas state agencies and licensing boards, apparently ventured beyond the scope of their expertise and unbelievably released findings of fact regarding the efficacy of Burzynski’s treatment, which the Board Staff stressed was not at issue in the hearings. At times, their language parroted alternative medicine talking points:
Many [of Burzynski’s] patients elected to participate in the FDA-approved clinical studies, and others chose to participate in “personalized medicine” treatment that targeted the cause of the cancer rather than the location of that cancer. Because of Dr. Burzynski’s treatments, several terminally ill patients recovered. . . .
The alternative therapy provided by Dr. Burzynski during the period at issue has become more accepted and mainstream. During the hearing, Staff took the position that the applicable standard of care regarding Dr. Burzynski’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.
Here the judges are not talking about antineoplastons, since that is manufactured and administered by Burzynski alone. Rather they are referring to the use of genetic testing to guide cocktails of chemotherapies. In Burzynski’s case, however, he apparently always adds sodium phenylbutyrate. Because that component of the treatment is unique to Burzynski, his personalized gene-targeted therapy simply can’t be mainstream or “more widely accepted.” Given that there is no theory or mechanism behind why sodium phenylbutyrate or its metabolic derivatives should work if they are included in a chemo cocktail, it’s not clear how the judges could even justify it as part of off-label innovation.
Even though Burzynski was ultimately found to be sanctionable for more than 130 violations, and even though the Board attorneys recommended revoking his license and then staying that revocation, as a sort of last chance the Board decided to merely stay a suspension and issue a reduced fine of totaling $60,000—$300,000 less than the lawyers had recommended. He will also be saddled with a Board-appointed monitor to ensure that he is following the Board’s ruling. According to a press release from the Medical Board, reported in the American-Statesman:
The violations as detailed in the order, and supported by the judges’ findings, show a pattern of misleading patients at the Burzynski Clinic. These misrepresentations can lead to direct harm to the public if left unchecked. In total there were over 130 violations cited.
Among the violations are numerous instances of misrepresenting services billed; failing to supervise and allowing those working in his clinic to misrepresent themselves to patients; and a continued failure of not informing patients of potential risks before and during treatment.
The administrative sanctions and penalty levied by the Board as part of Dr. Burzynski’s order are in line with the disciplinary sanction guidelines set out in Board rules. Through the probationary terms of this order, Dr. Burzynski is required to make the necessary changes to his practice to ensure the health and safety of all patients seeking treatment at his clinic.
Considering the infamy of the Burzynski Clinic and its impressive history of patient exploitation, many critics—and a large segment of the cancer community—are angered by the outcome. Nonetheless, Burzynski has had his day in court, was given due process, and still failed to convince a demonstrably gullible pair of judges that he was innocent of over 130 violations. In addition to monetary sanctions, he will be forced to take classes in billing and ethics and to have a Board-appointed monitor for the foreseeable future to make sure that he does not continue misleading patients at the Burzynski Clinic. All considered, then, the prospects for patients are therefore marginally improved, and the ruling should therefore be considered a small, unsatisfying victory for public health.