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News of the Day ... in Perspective

12/21/2004

FDA incapable of protecting public safety, says official.

In testimony before a U.S. Senate hearing, FDA safety officer David Graham said he had felt pressures to water down safety concerns about Vioxx. He also told Congress that he felt the FDA was incapable of protecting the public from other dangerous drugs.

According to documents made public Dec. 10, nearly 20% of FDA scientists said, in a 2002 survey, that they were pressured to approve a medication despite their reservations. Additionally, two-thirds of scientists questioned by the Inspector General of the Department of HHS said they lacked full confidence in the FDAs ability to monitor side effects of prescription drugs after they are marketed (Reuters, Ariz. Daily Star, Dec. 17, 2004).

The FDA has failed to act on a 2002 petition from the Whitaker Health Freedom Association to change warning labels on statin drugs to alert consumers of possible CoQ 10 depletion that can cause myopathies, including cardiomyopathy, potentially a worse problem than Vioxx effects.

According to the Alliance for Human Research Protection, the FDA also failed to analyze serious side effects of neurontin and SSRI (selective serotonin reuptake inhibitor) antidepressants until testimony by grieving parents of suicidal children caused a public furor.

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