Texas Medical Board Accuses Stanislaw "I Cured Cancer, Bitch!" Burzysnki of Deceptive Advertising

Categories: Texas

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Someone is in trouble...again.
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.

- 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.


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3 comments
BrettMDatDrSocial
BrettMDatDrSocial

Sometimes medical boards place people on probation because they are incompetent themselves and immune to good judgement. I cannot comment in this situation as I have not read the study protocols, peer-reviewed literature, and what, specific chemical compounds compose in  "anti-neoplastins."


Is the phhysician using the "anti-neoplastins," as mono-therapy or as combination therapy. Who is the IRB, what phase is the clinical study, was the advertisement "IRB approved?"  If it was, the medical board should be sued for overstepping their bounds. I say this because the medical board in Missouri has ignored repeated acts of patient harm caused by the pathology chair, ignored that the pathology chair reprimanded good care of myself, including an appropriate bone marrow biopsy, and then reprimanded the reporting of the Chair's unethical conduct as unethical. Difficult to imagine the truth being more distorted than that. When an unhealthy narcissism leads a department, group or collective narcissism can develop and much of what is discussed in such departments if not true. It is a horrible place for an honest person to be. Tell the truth and appear dishonest, or lie to fit-in and appear honest? 


I have found that medical boards, at least in Missouri actually harm patients through administrative negligence.  A group of physicians, administrators, have already testified against the medical board in my State. 


Pardon me, but the patient comes first, not the Board member's deference to someone with the academic title of "Chair." 


Is he using these treatments as "adjunctive," or not. 


The medical board is accosted when they don't act soon enough about patient harm, and then they apparently make up for that by reprimanding foolish nonsense. 


Instead of a strictly punitive method of medical regulation, we could perhaps progress through a progressive, big-brother type of regulation. The medical board should not be making up lies and gossip about applicants. The only solution to that is much data and truth. Video and audio recordings, along with GPS tracking are very useful for establishing innocence.


A crazy pathology chair at UMKC told everyone who evaluated me at Children's mercy hospital, that the "resident broke into her house, is running a methamphetamine laboratory, that he is recovering from drugs, and to not expect them to do well on the rotation." Clearly the medical board should have reprimanded the Pathology Chair for repeatedly harming patients as I have detailed on LinkedIn and elsewhere on this site. Instead the medical board reprimanded me for the UMKC Pathology Chair's incompetent clinical documentation. She did not know the difference between a sign and a symptom and reprimanded me for a symptom that I never complained of. All of this is in addition to many other things and her continual lying, including telling the medical board that she was unable to evaluate my clinical competency because I left the residency program. However, she already evaluated my clinical competency for level in the ACGME letter of core competencies on file in the ACGME office.


We need equity in medical regulation, to guard against over-dramatization., and to hold medical board members accountable to make reasonable decisions. Is it reasonable for them to write that I blamed someone repeatedly without a single example, for them to overlook that the pathology chair used my social security number to bill $5,000 (a receipt) for her hospitals laboratory proficiency testing. 

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