Incompetent IRBs and a corrupt FDA prevent research on RSD / CRPS

I have been asked by Jim Broatch, Executive Director of the Reflex Sympathetic Dystrophy Syndrome Association, to clarify if the "culprit" for preventing RSD / CRPS studies in the United States are Institutional Review Boards (IRBs) at universities or the FDA .

My reply:

IRBs at many universities are incompetent and the FDA is corrupt when it comes to approving studies for RSD / CRPS

 

The FDA and IRBs have both prevented the approval of clinical research initiated by clinical investigators in the United States.

 

Many IRBs don’t know how to manage risk associated with high-risk studies like the ketamine coma procedure. So rather than render the final decision for the study to go forward as they should at their university  – they tell the investigator to go the FDA for a final decision which creates a bureaucratic nightmare and huge costs for the clinical investigator.

 

The FDA relies on a user fee system that drug companies pay for the agency to have their products reviewed.  In other words, IRBs delegate their responsibility to the FDA. But the FDA ONLY makes money to approve drugs for clinical research when studies are initiated by drug companies. In fact, it is estimated that over 60% of the cost of running the FDA’s Center for Drug Evaluation and Research – mostly for salaries - comes from the drug companies.

 

In my opinion, money has corrupted the FDA to its core when it comes to approving studies initiated by clinical investigators. The FDA refuses to tell IRBs to do their job.

 

The following is worth reading:

http://www.rsdfoundation.org/en/FDA.html

We owe Robert Schwartzman MD, Professor and Chairman of Neurology, significant recognition for his courage and dedication to clinical research on this horrible disease. His report to be published shortly in the journal called PAIN will be a landmark paper.

http://rsdhealthcare.org/outpatient_ketamine.htm

I think you would be doing a great service to your members to publish my reply to your inquiry on your website.   

Anthony  Kirkpatrick, MD, PhD

The International Research Foundation for RSD / CRPS

September 19, 2009