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TIME Magazine

TIME Magazine asks Is the FDA on drugs?

Wednesday, December 15, 2010 by: David Gutierrez, staff writer
Tags: TIME Magazine, FDA, health news

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(NaturalNews) Reflecting on the undue influence that drug giant GlaxoSmithKline appears to have exhibited over the FDA's decision-making process regarding the diabetes blockbuster Avandia, Time magazine author Massimo Calabresi asks, "Does the FDA have a drug problem?"

The saga over Avandia has embarrassed the FDA and further tarnished the reputation of the already embattled pharmaceutical industry. As early as the late '90s, researchers were already sounding alarms over the drug.

"In April of 1999, FDA medical reviewer Robert I. Misbin reported to his FDA supervisors that a GlaxoSmithKline drug for Type 2 diabetes then under review, Avandia (rosiglitazone), appeared to increase the incidence of congestive heart failure in study participants," writes Jonathan W. Emord in his book The Rise of Tyranny.

Internal memos show that GlaxoSmithKline was already aware that the drug drastically increased patients' risks of heart attack and death -- yet instead of acting to withdraw the drug or voluntarily label it, the company embarked on a campaign to convince the FDA that evidence of the drug's risks was contradictory and inconclusive.

That campaign was a resounding success. It was only in recent weeks that the FDA finally moved to limit access to the drug, banning its use except in cases where every other possible drug had been tried and failed.

"Such examples of the drug industry's outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring," Calabresi writes.

"Over the past two decades, as drug after drug has been recalled after winning FDA approval, it has been hard not to wonder if FDA regulators have been captured by the drug industry."

Part of the problem lies in U.S. law, which places the entire drug safety testing burden on pharmaceutical companies, making the FDA dependent on company data for its evaluations. Yet also to blame is an agency that often seems reluctant to crack down on the companies it is supposed to be regulating.

"Companies are always going to present their best face," Misbin said. "It's our job to say no."

Sources for this story include: http://www.time.com/time/health/article/0,85... http://www.lawyersandsettlements.com/article....

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