The Texas Medical Board has accused controversial Houston doctor (we use that term loosely) Stanislaw Burzynski of making false claims in how he advertised his cancer treatments (another term used loosely).
Filed in December, the complaint comes a year after a similar complaint from the U.S. Food and Drug Administration, which has also issued letters accusing Burzynski's staff of failing to failing to obtain informed consent and inaccurately reporting patient outcomes.
The Texas Medical Board complaint alleges that the Burzynski Research Institute's and Burzynski Clinic's "internet-based advertising was false, misleading, and violated federal law," and references an October 2012 FDA letter accusing Burzynski's companies of violating the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.
Specifically, the FDA letter stated that claims made about a drug Burzynski uses to "treat" cancer -- antineoplastons -- on websites, YouTube, and in a KHOU interview of physicians employed by Burzysnki "suggest that the drugs are 'well tolerated,' 'work without causing side effects,' and have demonstrated 'remarkable' results. The totality of these claims suggest that Antinoplastons [sic], investigational new drugs, are safe and/or effective for the treatment of the various types of brain tumors...when they have not been approved for these uses." (For some reason, Burzynski is regularly blown by local TV news).
The Texas complaint also cites as an "aggravating factor" the fact that the TMB placed him on a 10-year probation in 1994, for treating cancer and AIDS patients with antineoplastons "in violation of state and federal laws."
No date has been set for the hearing.
Richard Jaffe, the attorney representing Burzysnki in the TMB complaint, denied the allegations of false advertising in a filed response, which also states that "the informal FDA letter which is the basis of this case is non-binding and does not constitute final agency action. For this reason, federal courts do not consider such letters as avidence of a violation of federal law. Further, the federal courts have held that such letters are not even admissible."
The response also asserts that the online advertising at issue "contains truthful and accurate information concerning the investigational agents known as antineoplastons and the results of the clinical trials."
However, the FDA alleged multiple problems with the Burzysnki Research Institute's data in a December 3 warning letter, and several inspection reports, including:
- classifying some patients as having a "complete response" -- meaning a "complete disappearance" of a tumor for at least four weeks -- when the outcomes showed otherwise.
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- failure to inform all test subjects that they might incur additional costs for participating in clinical trials
- failure to report "adverse events (AEs) experienced by study subjects, including 18 cases of hypernatremia" (elevated sodium levels)
- one investigator "destroyed critical subject case history records...or misplaced case history records" for all subjects.
The FDA's warning letter references a reply from the Burzysnki Research Institute from April 2013, outlining how the Institute would correct the problems. However, the FDA's letter states that not all of the new measures were adequate, and asked the Institute to readdress the problems in another letter.