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Kaiser Daily Health Policy Report
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Prescription Drugs | Experts Discuss Sales of BiDil, Implications for Race-Based Drugs
[Apr 10, 2006]

      Medical experts at a two-day conference hosted by the Massachusetts Institute of Technology discussed how "the much-hyped future of racially targeted drugs may have tanked even before it took off," citing lagging sales of NitroMed's BiDil, the Boston Herald reports (Crimaldi, Boston Herald, 4/9). FDA in June 2005 approved BiDil for use in black heart failure patients based on the results of a study that found the medication reduced their risk for heart disease. BiDil is the first medication approved by FDA for use in a specific racial group (Kaiser Daily Health Policy Report, 12/13/05). NitroMed's CEO and CFO both resigned in March amid disappointing initial sales of the drug. BiDil has "been hampered in part by the high copayments insurance companies charge for the new medication," the Herald reports. Experts at the conference criticized BiDil's clinical trials and FDA approval and stated that "the case against race-based pharmaceuticals is very strong but not yet closed." Nicholas King, an assistant professor at Case Western Reserve University, said race-specific drugs should be approved only when a racial difference exists in the health problem, the cause of the health problem differs by race and there is a "plausible hypothesis" for a mechanism that functions better in one racial population than another. He said, "It is extremely unlikely that a pharmaceutical will ever satisfy the criteria we set out because of the undeniable negative consequences of race-based pharmaceuticals." NitroMed spokesperson Jane Kramer said, "We don't call it race-based medicine. We call it evidence-based medicine." Juan Cofield, president of the New England Area Conference of the NAACP, which supports BiDil, said, "My concern is that this is an esoteric discussion about a drug that is saving the lives of thousands of black folk and improving the quality of life for black folk" (Boston Herald, 4/9).


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