FDA: Protecting Big Pharma from lower profits

by soccerdad

From today'a WaPo FDA Urged Withholding Data on Antidepressants

Emphasis is mine

The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer's decision to amend its drug label to say that the drug was associated in studies with increased hostility and suicidal thinking among children.

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Several representatives noted that the study results were obtained at tremendous cost to the American public because Congress granted companies profitable patent extensions as an incentive to conduct the trials.

Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said it was absurd to give companies profitable patent extensions on their drugs to encourage the trials and then limit dissemination of the results. He said his staff had estimated that a patent extension given to Pfizer Inc. was worth $1 billion dollars. Wyeth Pharmaceuticals, he said, made $500 million.

The conclusions are obvious