Congress last month passed the FDA Amendsment Act, which among other things, promotes tracking of adverse reactions after a drug is approved and in wide use, a move that pharma fought for years. But questions remain about whether that is a substantive fix or a public-relations move by the FDA and industry designed to fend off stronger government demands,
The Seattle Times writes.
Graham, an FDA medical reviewer who sought whistleblower protection in early 2004 after the agency investigated leaks about links between antidepressants and teenage suicides, tells the Times that the bureaucratic leopard shows the same spots. He also created a furor by linking Vioxx to a huge number of heart attacks and then testified before a Senate committee that the agency wasn't protecting Americans. More recently, he urged that Glaxo's Avandia diabetes pill should be withdrawn.
"The FDA remains stuck in a view that gives the companies and drugs a free pass," he says. "The FDA has allowed companies to set the standards and handle the reviews...The pro-industry culture and its decision-making hasn't changed."
And in response to the observation that the same FDA office that approves drugs helps decide whether those drugs should be withdrawn, Graham says this "creates a conflict of interest." As an example, he cites Avandia, which was approved in 1999. In recent years, some studies, including one last month, linked it to increased risk of heart attacks. The FDA voted this summer to beef up warnings on its label but keep it on the market.
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