2001 F.D.A. reprimanded the drug’s maker for playing down safety concerns: [$3B per year then 2007 concerns seems validated ...

Years Ago, Agency Was Warned of a Drug’s Risks | By STEPHANIE SAUL and GARDINER HARRIS | Published: May 24, 2007

A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug’s maker for playing down safety concerns, according to documents from 2000 and 2001.

The documents, found in a reporter’s search of the F.D.A.’s database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug’s maker, GlaxoSmithKline, was seeking to minimize Avandia’s risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine.

The F.D.A. has acknowledged that the company alerted the agency to concerns about a cardiovascular risk as early as 2005, based on the company’s analysis.
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A Harvard professor who is a critic of the nation’s drug approval process, Dr. Jerome L. Avorn, yesterday drew parallels between the regulatory histories of Avandia and Rezulin, which had been a popular drug in its day.

With both drugs, “there were signals of a very dangerous side effect that were ignored,” he said. “Then massive marketing created a tremendous uptake of the drug.”

Last year, worldwide sales of Avandia exceeded $3 billion, making it one of Glaxo’s top-selling drugs.
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Dr. Nissen has said that, according to his analysis, any person with Type 2 diabetes has a 20.2 percent chance of having a heart attack during a seven-year period. But with Avandia, he says, that seven-year risk would increase to 28.9 percent.
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Even before Dr. Nissen had started working on his paper, Glaxo alerted the agency in 2005 and in 2006 that internal analyses had shown an increased risk of heart attacks. But the company also submitted a study of patients that it said showed Avandia was no riskier than other diabetes drugs. None of this analysis was specifically communicated to the public or doctors, although the company posted it on a Web site.
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The briefing did little to settle concerns among some in Congress that the F.D.A. had been slow to alert patients about the drug’s potential risks to the heart, according to several staff members who were present and who spoke on condition of anonymity because the briefing was confidential. ...