More FDA Suppression on Antidepressants

The FDA earlier released a suicide precaution for antidepressants. However, it released a report by its primary medical officer, Dr. Andrew Mosholder, who examined the antidepressant data and based on his finding of a statistically significant risk of drug-induced suicide for children recommended that FDA follow a "risk management strategy" to discourage physicians from prescribing antidepressant drugs for children off-label.

The agency had prevented Dr. Mosholder from presenting his analysis of the clinical trials conducted in children or to make his recommendations known to FDA's advisory committee, not to mention physicians and the public. The FDA submitted Dr. Mosholder's report to the Congressman Joe Barton, Chairman of the Committee on Energy and Commerce. Barton issued a press release suggesting hearings are likely.

The FDA's feeble explanation about its failure to take precautionary action is reminiscent of the recent testimony by FBI officials whose ineptitude and failure to take action, in large measure, resulted in the 9/11 tragedy.

New York Times April 16, 2004

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