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Organizations Call for Genomics -- Not Race -- to Guide FDA Approval of BiDil

NEW YORK, June 15 (GenomeWeb News) - Anticipating an FDA committee meeting scheduled for tomorrow to discuss the application for the heart failure drug BiDil, a coalition of several organizations today expressed concern that the treatment has been characterized as "race-specific," and called for additional clinical trials that will take a closer look at the genomic basis for patient response.


The organizations said today that they are forming a commission to advance personalized medicine based on molecular data, rather than race, which the groups dubbed a "proxy for biology" in a statement issued today. These groups include the National Minority Health Month Foundation, the Alliance of Minority Medical Associations, the Association of Black Cardiologists, the Genetic Alliance, the International Society on Hypertension in Blacks, the JointCenter for Political and Economic Studies, the Health Policy Institute, the National Association for the Advancement of Colored People, and the National Medical Association.  


The newly formed National Commission on Health, Genomics, and Human Variation will take steps to "develop a comprehensive strategy, speak out on the application of 'social race' in medical advances, and encourage additional clinical trials with significant minority representation," said Gail Christopher, vice president of the Office of Health, Women, Family, Joint Center for Political and Economic Studies, in a statement. Christopher will serve as co-chair of the commission.


BiDil's ties to social race stem from the African American Heart Failure Trial (A-HeFT), which tested the NitroMed drug in 1,050 patients who self-identified as African American/Black. The trial showed that patients taking BiDil (isosorbide dinitrate/hydralazine) experienced a 43-percent increase in survival, a 39-percent reduction in the rate of first hospitalization for heart failure, and an improved quality of life.


But Ngozi Robinson, director of health disparities initiatives at the Genetic Alliance, said in a statement that the trial used race "as a proxy -- a profoundly imperfect one -- to identify patients who might find benefit in this particular drug."


As an alternative, "We strongly encourage Phase IV monitoring or testing to determine at the cellular level patients that would benefit from BiDil," Robinson said. "Through the development of a test to indicate the patient's molecular sensitivity to BiDil, we know that all those who benefit from BiDil will get it and that they will be responsive."


Christopher called for a "larger study" to examine BiDil "in a heterogeneous population with the same clinical presentation or diagnosis -- stage 3 and 4 cardiovascular disease," adding that "race-based claims are not credible in the face of modern genetic science."

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