Are Health Regulators and the FDA to Blame?

New York Attorney General Eliot Spitzer has criticized the U.S. Food and Drug Administration for failing to ensure that the drug industry publicly disclose any negative results about its drugs. This comes after charging GlaxoSmithKline of suppressing negative data about its antidepressant drug Paxil® in June 2004. That case was settled in August.

According to Spitzer, “The FDA’s failure to jump into the issue of disclosure of clinical testing in an aggressive way is very problematic… From day one, when we announced the Glaxo case, we have been saying, ‘Where is the FDA?'”

In that case Spitzer charged that GlaxoSmithKline suppressed several studies that failed to demonstrate that Paxil® was effective in treating children and adolescents and cause a possible increase in suicidal thinking and behavior.

Spitzer said he would like to see the FDA take the lead in ensuring full disclosure. He stated, “We were not seeing the type of behavior at the FDA that we wanted.”

Spitzer thinks the companies hurt themselves by failing to fully disclose risks associated with their drugs. He points to Merck & Co. and their handling of Vioxx® as an example. They have been accused by some industry experts of selling Vioxx® for five years despite evidence of cardiovascular risks associated with the drug.

On November 8, 2004 Spitzer also requested documents from Pfizer, Inc. relating to possible promotion of unnamed drugs for unapproved uses.

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