Archive for the ‘FDA and clinical trials’ Category

The FDA and Clinical Trials

Sunday, September 30th, 2007

Attacked in a report by the HHS Office of Inspector General (OIG), The Food and Drug Administration does not know how many clinical trials are going on at any given time, how many sites are conducting them, and how many institutional review boards (IRBs) are overseeing them. According to this Government report just released, (Sept. 28) the FDA audited fewer than 1% of the testing sites and, according to the New York Times, when inspectors did appear, they generally showed up long after the tests had been completed. The FDA has 200 inspectors to police some 350,000 clinical testing sites, so it’s not surprising that that many of them audit sites only part time. Privately financed noncommercial trials have no federal oversight whatsoever.

The breathtaking shock is that cats and dogs get better protection as research subjects in the U.S. than human beings. Animal research centers have to register with the Government, must keep track of subject numbers, have unannounced spot inspections and take care of problems or face closing, none of which applies to human drug or medical device trials. Perhaps we should persuade PETA to join the HHS in exposing the FDA.

This Inspector General report assailing the FDA makes one wonder about the overall reliability of some studies coming out of thousands of medical facilities, many reported in respected peer-reviewed medical journals. The media, feeding off this literature, helps drive the public appetite for more and more medical news advertised as “scientific breakthroughs.”