FDA Scientists Complain to Obama about Corruption

Monday, January 12, 2009

Nine Food and Drug Administration (FDA) scientists have written to Obama’s transition team, complaining of managerial corruption abetting business interests, and calling for reform of the evaluation and approval process for new products and devices. In straightforward terms, the letter states, “The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk…Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.” The letter focuses on the approval, despite multiple protests, of computer-aided mammography devices which may have led to unnecessary breast biopsies. Tom Daschle, Obama’s pick to head the Department of Health and Human Services, acknowledged this poor oversight in his book, Critical: What We Can Do about the Health-Care Crisis, and will be responsible for any possible restructuring at the FDA. The FDA has long been criticized for its close ties to business, especially in light of the Vioxx scandal, in which pharmaceutical company Merck pulled its pain-relieving drug off the market only after a study estimated that 27,785 people died of heart attacks caused by the drug between 1999 and 2003.

FDA Scientists Complain to Obama of ‘Corruption’ (by Ricardo Alonso-Zaldivar, Associated Press)
FDA Scientists Ask Obama to Restructure Drug Agency (by Alicia Mundy and Jared Favole, Wall Street Journal)
Tom Daschle (Allgov)


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