Burzynksi Research Institute IRB Fails Yet Another FDA Audit

Burzynksi Research Institute IRB Fails Yet Another FDA Audit

September 26th, 2013 // 1:15 am @

Source: Pharmalot

It has happened three times since 2010 where an IRB has been found to violate several GCP procedures for clinical trials. The latest audit of the Burzynski Research Institute , based in Houston, found that there was a failure to ensure that safeguards were in place for children, and a lack of reporting AERs.

The IRB also was found to use a wrong procedure to expedite approvals for new test subjects, for both children and adults. It also failed to check for risks to patients related to benefits and its standard procedures for doing reviews. There also were no written procedures to report problems to FDA or any other agency. There also was a serious lack of safeguards.

Also, the earliest of these inspections, back in 2008, caused FDA to send the IRB an FDA warning letter about related issues.

Some of these involved a failure to make sure that risks to the patients were made as infrequent as possible, and that informed consent was obtained. There also was a failure to stop financial interest conflicts among people reviewing clinical projects, and failure to keep copies of recent proposals and IRB meetings.

It should be noted that FDA has been watching this IRB for years, which is run by the doctor Stanislaw Burzynski. He is a very controversial doctor who developed what is known as antineoplastin therapy to treat some forms of cancer. For many years, this new approach was questioned and evidence of its success is hard to find.

FDA and the TX Medical Board once tried to close his practice. He also was indicted in 1005 for selling an unapproved drug, and also for mail fraud. He became famous when Suzanne Sommers raved about him in her book about various cancer treatment alternatives.

The agency has been watching this IRB for many years, such as regarding conflicts of interest. An FDA report 10 years ago noted that one reason an inspection was ordered was to see if the associates working at the IRB and working on clinical trials also were approving clinical studies of patients for whom they were giving care.

We can’t say what will come of this latest audit, but this is the third failed audit in the last three years, and little changed since FDA sent its warning letter in 2010.

Subscribe Now

Featured Partner