Obama told of “corruption” involving clinical trials
This is my site Written by Alex on January 9, 2009 – 11:12 am   

A small group of scientists from the Food and Drug Administration in a letter to President-elect Obama complained of “corruption” at the agency in how medical devices were approved.

 

The letter puts the spotlight on how clinical trials are only as effective as the way in which the results are interpreted. In one case, results of clinical trials on computer-aided mammography devices showing they were ineffective were allegedly ignored by the FDA and the devices were repeatedly recommended for approval.

 

The FDA conducts on-site reviews of approximately one percent of all clinical trials. It’s not as simple as saying that the FDA is simply choosing to ignore results. That number is so low because of the staggering growth in the sheer volume and number of trials in an atmosphere of government deregulation in the last decade. The letter to Obama could be the first shot fired in a campaign to strengthen the FDA’s review processes of clinical trials. Such a campaign – while potentially painful for companies sponsoring clinical trials – could prove beneficial to trials subjects and to patients throughout the world.

(Read full story here.)

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