Three days ago, on September 19, 2009, a remarkable statement was posted by Anthony Kirkpatrick, MD, PhD on behalf of the The International Research Foundation for RSD / CRPS. As many of you know, Dr. Kirkpatrick is, along with Robert J. Schwartzman, MD, one of only two phyisicians in the United States making referrals for ketamine coma treatments. The statement is as follows:
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/PatientInfo...t_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
http://www.rsdfoundation.org/en/research.html
A couple of thoughts. First, the RSDSA "What's New?" page at
http://www.rsdsa.org/Whatsnew.html was last updated yesterday, September 21, 2009, without reference to Dr. Kirkpatrick's statement. I can only assume that the RSDSA is considering it's position carefully.
Secondly, this controversy notwithstanding, the nature of the reference to Dr. Schwartzman's upcoming article in
PAIN - the most prestigious journal in the field - is enough for anyone to sit up and take notice.
Mike
ps A little while ago under Carrie's thread, I posted an incredible before and after testimonial via broadband videos as to what ketamine coma therapy
can mean in cases of horrific and chronic CRPS when it works well.
http://neurotalk.psychcentral.com/thread103585.html In that case, Dr. Kirkpatrick's interviewed over a two year period a young woman otherwise known as Shannon Stocker, MD, whose name hasn't appeared in these pages for almost two years, seven months after she had her coma treatment.
http://neurotalk.psychcentral.com/sh...ad.php?t=32686 With results like this, even in no more than 50% of cases, little wonder that Drs. Schwartzman and Kirkpatrick shoulder on as though this was a holy crusade.