Clinical Trial Results Too Often Delayed: Part II
An article published today in the New England Journal of Medicine confirms what we have described as a serious problem in the manner in which the FDA allows drug companies to control the release of data in clinical trials. The authors conducted a meta-analysis of clinical trials evaluating the effectiveness of antidepressants. They found that the companies published 97% of the studies in which positive results were found but only 12% of studies in which the findings were negative.
While the drug companies must report the results of all their clinical trials to the FDA, the agency at present is prohibited from publishing the results on its own.
This system has to be changed. Not only do human subjects and patients have the right to review all material information about the drugs or therapies they have been prescribed, but physicians also have the need to review material information before they suggest a particular drug or treatment. While BigPharma may have a monetary interest in keeping negative information about their products from the public, the interest in public health is what the FDA is obligated to protect.
Alan Milstein
0 TrackBacks
Listed below are links to blogs that reference this entry: Clinical Trial Results Too Often Delayed: Part II.
TrackBack URL for this entry: http://sskrplaw.com/cgi-bin/mt/mt-tb.cgi/45
Leave a comment