Burzynski Research (BZYR)

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More about the unethical, immoral crook, Stanislaw Burzynski:

"FDA Vs.Stanislaw Burzynski, Again: His IRB Fails Another Inspection

Will this be a case of ‘three strikes and you’re out?’ Three times since 2010, an institutional review board has been found by the FDA to have violated various procedures for organizing clinical studies. And the latest inspection at the Burzynski Research Institute in Houston noted a failure to ensure that safeguards were in place for children and an inability to report adverse events, among other things.

What else? The IRB used an ineligible procedure for expediting approvals for new subjects, both children and adults; failed to determine the risks to patients in relation to benefits and its own standard procedures for conducting reviews, and there are no written procedures for reporting problems to the FDA or anyone else. Moreover, the noted lack of safeguards for children was a repeat offense (this is the 483 report).

In fact, the earliest of the three inspections, which took place in December 2008 (look here), prompted the FDA to send a warning letter about similar issues, such as a failure to ensure that risks to patients were minimized and that informed consent was sought; a failure to prevent financial conflicts of interest among those reviewing projects, and a failure to maintain copies of proposals and minutes of IRB meetings (here is the letter). The other took place in 2010 (see this).

There is a back story, however. The FDA has been watching the IRB for some time, given its affiliation to the Burzynski Clinic, which is run by Stanislaw Burzynski, a controversial physician who developed something called antineoplastin therapy to treat cancer. For years, though, this approach has been questioned and hard evidence of success is scarce, according to the American Cancer Society (read this).

At one point, the FDA and the Texas Medical Board attempted to shut down his practice. He was indicted in 1995 for marketing an unapproved drug and mail fraud, among dozens of other charges, all of which were dropped, except for one charge for which he was acquitted. He gained national notoriety, however, after actress Suzanne Sommers wrote about him in a book devoted to alternative cancer cures, prompting both fame and scrutiny (watch an NBC Dateline report here).

The IRB is not nearly as high profile, of course, but this operation may provide an opening for the FDA to crack down. For years, the agency has been monitoring the IRB activities, such as conflicts of interest. For instance, an FDA report in 2001 noted that one reason an inspection was requested at the time was to determine if research associates employed by the IRB and working on clinical studies were also approving studies of patients for whom they were providing care (read it here).

Another type of conflict was noted more recently. In a warning letter issued to the IRB in 2009, the agency noted that Carleton Hazelwood, who is listed as the IRB chairman, was also listed as a clinical investigator on a form entitled "Certification: Financial Interests and Arrangements of Clinical Investigators," and was also listed as being an ex-officio advisor to a Central Registry Control Committee/Data Monitoring Committee. “Therefore, you had a conflict,” the FDA wrote.

What may come of the latest inspection is unclear. As noted, this is the third failed inspection report since 2010 and the agency has been keeping watch for more than a decade. And not much has apparently changed since the FDA sent a warning letter three years ago. Meanwhile, we called the IRB, which is located in the same Houston building as the clinic, and left a message for Burzynski and Hazelwood. We will update you with any reply.

STORY ENDS HERE"

http://www.pharmalive.com/fda-vsstanislaw-burzynski-again-the-irb-fails-an-inspection?cid=nl.phrm01