Stanislaw Burzynski: Slapped Down by the FDA Once Again!

I'm clapping too, Mardibra!  It's another step toward shutting him down, we can hope, but I won't hold my breath!   For reasons that escape me (understaffing? jurisdiction? loopholes? red tape? or ????), he hasn't been shut down long before now.  His infamous antineoplaston "research" Institutional Review Board was riddled with errors, omissions, and legal issues when he started his trial back in 2009.  These are MAJOR issues, and I'm astounded that he's still able to do what he's doing!  How can this be?

A few excerpts from FDA's Warning letter Re: Burzynski Research Institutional Review Board from 2009:

"The IRB approved research without determining that the following criteria were met: that risks to subjects were minimized ...and risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result ..."

"It is unclear why the IRB allowed the study to go forward in humans when additional toxicity studies in animals were requested. In addition, it is unclear why the IRB allowed Dr. (b)(4) to continue (b)(4) the study when it appears that he initiated this research study, i.e., began dosing subjects, prior to obtaining IRB approval."

"The IRB failed to prepare, maintain, and follow written procedures for conducting its initial and continuing review of research .... Specifically, the IRB has no written procedures for conducting reviews of device studies to determine whether they involve a significant risk device and had no evidence that it had in fact conducted such reviews ..."

"The IRB failed to ensure that informed consent would be sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required ...and that informed consent would be appropriately documented in accordance with and to the extent required..."

"The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest, except to provide information requested by the IRB..."

"The IRB failed to conduct continuing reviews for the following IRB approved studies..."

"The IRB failed to maintain copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators and reports of injuries to subjects, and correspondence with investigators..."

"The IRB failed to maintain copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators and reports of injuries to subjects, and correspondence with investigators..."

"Each IRB is required to have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution... Our inspection revealed that, in some instances, when an IRB member had a conflict of interest for a particular study, another person, who was not an IRB member, was allowed to take the place of the conflicted member and participate in the IRB's action. There is no provision in FDA regulations for this type of action..."

Yikes. 

It's maddening, isn't it?

Between the FDA (illegal marketing), the FTC (fraudulent advertising), state medical board (malpractice, negligence, etc.), and legal agencies (murder, manslaughter, etc.), it seems unbelievable that he remains free to practice after all this time.

It's hard to imagine anyone supporting and/or defending him but as we've seen, he does have some fans.  Even here on BCO.  Shameful, if you ask me.

Tragedy, for sure.  Sadly, she was one in a long (and ever increasing) list of Burzynski victims.  I feel such sorrow and outrage for their families for being victims of fraud, on top of the devastating loss of loved ones. 

I wish there was something more "we" could do. 

Burzynski's scammy and fraudulent history with this goes WAY back.  For the life of me, I just can't understand why he's still free to continue!

The following quotes are from almost 20 YEARS ago (and this is just one of many lawsuits against him!), yet it seems nothing has changed and he's still practicing medicine, treating cancer patients.  How is that??  And more importantly, how can we make a difference?  Yorkiemom, do you have any ideas about spreading the word and/or getting attention from one of the networks? 

Source: 1994 US Court of Appeals Upholds Burzynski Fraud Conviction

"...The antineoplastons treatments administered...were illegal, and Dr. Burzynski knew or should have known it. To uphold the district court's judgment on the Fund's claim of fraud, we must additionally decide that Dr. Burzynski had a duty to disclose to the Fund the illegality of the antineoplastons treatments. For three reasons, we conclude that he did."

"...Because we conclude that Dr. Burzynski failed to disclose the illegality of his antineoplastons treatment to the Fund when he had a duty to do so, we uphold the district court's judgment on the Fund's claim of fraud."

"...Today we write the latest chapter in a medical iconoclast's long history of litigation over an unorthodox cancer treatment. The district court granted summary judgment for the plaintiff/appellee, the Northwest Laundry and Dry Cleaners Health & Welfare Trust Fund, an ERISA health insurance fund, after finding that the defendant/appellant, Dr. Stanislaw R. Burzynski, had defrauded the plaintiff and violated the terms of the health plan. We agree that the defendant may not trick the plaintiff into paying for an unlawful, unapproved drug."

Quackwatch on Burzynski has lots more reading material, including applicable references and source citations.