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NY Attorney General Spitzer takes aim at health regulators
November 13, 2004
New York Attorney General Eliot Spitzer on Friday criticized the U.S. Food and Drug Administration, and Health and Human Services Secretary Tommy Thompson, for failing to ensure that the drug industry publicly disclose negative results about its drugs. The failure, he said, has allowed companies to suppress negative information to the detriment of patients.
Spitzer sued GlaxoSmithKline Plc in June, charging the company with suppressing negative data about its antidepressant Paxil. The company settled the suit in August. "The FDA's failure to jump into the issue of disclosure of clinical testing in an aggressive way is very problematic,"
Spitzer told the Reuters Health Summit in New York. "From day one, when we announced the Glaxo case, we have been saying, "Where is the FDA"?" FDA spokesman Brad Stone said the agency discloses "everything that we are legally able to disclose" and tries "to do so as quickly and accurately as possible." A spokesman for the Health and Human Services Department did not return calls seeking comment.
Spitzer charged GlaxoSmithKline with suppressing several studies that failed to demonstrate that Paxil was effective in treating children and adolescents and caused a possible increase in suicidal thinking and behavior. Spitzer said that he does not believe in legislating policy and would like to see the FDA take the lead in ensuring full disclosure. He said the reason he filed the GlaxoSmithKline suit was because "we were not seeing the type of behavior at the FDA that we wanted." "As a matter of public policy debate it was remarkable that the FDA hasn't done more," Spitzer said. He also criticized the failure of the U.S. Health and Human Services department to do more. "I was surprised that Tommy Thompson at HHS didn't do something on this. It seems to me to be a no-brainer," he said. Spitzer said drugmakers hurt themselves when they fail to fully disclose risks associated with their drugs. He pointed to Merck & Co. Inc.'s arthritis drug Vioxx, which was recalled in September after a clinical trial showed it doubled the risk of heart attack and stroke.
The company has been accused by some industry experts of selling the drug for five years despite evidence it was associated with these risks. "I don't know how Merck calculates their concerns and the magnitude of their risk from Vioxx. I'm hard pressed to believe that they don't wish that they had pushed that information out much earlier." "Let doctors be doctors. Let them know what the risks are and make the best judgment call," he said.
A spokesman for the company said, "Merck has always communicated appropriate information about the overall safety and cardiovascular safety of Vioxx to the medical and scientific communities, to the media and regulatory authorities in a forthright and swift manner."
On Monday Spitzer requested documents from Pfizer Inc. related to its possible promotion of certain unnamed drugs for unapproved uses. "The increasing lesson I imagine the pharmaceutical industry will take from this is that early disclosure of the downside risk to patients is a wise approach," he said.
© 2004 India Daily