BiDilTreatment for Congestive Heart Failure
Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug
Leaders Call on FDA to Approve BiDil, a Promising Heart Failure Medication
WASHINGTON, June 15, 2005 -- Today at a joint press conference, key physician, research and civil rights groups concerned about health endorsed the approval of the heart failure treatment BiDil (isosorbide dinitrate/hydralazine) by the U.S. Food and Drug Administration (FDA). The group also expressed great concern that BiDil has been characterized as a "race-specific" drug.
Led by the National Minority Health Month Foundation, leaders were convened last week at a "Thought Leaders in Minority Health Forum on Personalized Medicine." In attendance were representatives from the Alliance of Minority Medical Associations; Association of Black Cardiologists; Genetic Alliance, Inc.; International Society on Hypertension in Blacks; Joint Center for Political and Economic Studies, Health Policy Institute; National Association for the Advancement of Colored People; and the National Medical Association.
The FDA Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet on Thursday, June 16 to discuss the new drug application for BiDil. The African American Heart Failure Trial (A-HeFT), which tested BiDil in 1,050 patients who self-identified as African American/Black, demonstrated that patients taking BiDil 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.
"As evidenced by the A-HeFT results, approval of BiDil will have an immediate and positive impact on the health and quality of life of many patients with heart failure," said Gary A. Puckrein, PhD, Executive Director of the NMHMF. "This can benefit every person who suffers from heart failure, regardless of social race."
"In the A-HeFT Trial social race is being used as a proxy -- a profoundly imperfect one -- to identify patients who might find benefit in this particular drug," said Ngozi T. Robinson, Director of Health Disparities Initiatives, Genetic Alliance, Inc. "We strongly encourage Phase IV monitoring or testing to determine at the cellular level patients that would benefit from BiDil. Doctors routinely run a variety of tests to guide their decisions on whether to prescribe medication, which medication to use and in what dosage. 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."
The group of leadership organizations also announced the formation of the National Commission on Health, Genomics and Human Variation, which will be co- chaired by Dr. Randall W. Maxey, President, Alliance of Minority Medical Associations, and Dr. Gail Christopher, Vice President of the Office of Health, Women, Family, Joint Center for Political and Economic Studies. The Commission will encourage research based upon science, coordinate the dissemination of accurate information on genomics and medicine, and help craft a new, more scientifically sound lexicon that will have functional utility in all academic, policy and clinical areas of endeavor.
These leaders are spearheading this effort in light of the growing use of "social race" as a proxy for biology. "I am so pleased so many organizations have rallied around forming a Commission to tackle the issue of medicine and genomics," said Dr. Christopher. "This type of substantive action is the appropriate response 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."
BiDil has stirred controversy in recent months because some have attempted to categorize it as a race drug. While acknowledging the value of the A-HeFT trial, the groups roundly rejected the designation of BiDil as a "race- specific" drug and pointed instead to possibility that the drug may be beneficial in a broader range of heart failure patients.
"The assertion that this is a race drug is misguided," said Randall W. Maxey, M.D., President, Alliance of Minority Medical Associations. "The A- HeFT researchers do not assert that all African American/Black congestive heart failure patients will benefit from BiDil, or that A-HeFT demonstrates that it is not effective in other population groups that can be categorized by social race."
The participating organizations understand the lessons learned from the A- HeFT protocol will contribute to the experiential database required to advance progress toward personalized medicine and improve the quality of health care for all Americans. They also recognize that concerted, prospective, anticipatory guidance is required from academic, policy and clinical leadership to assure that these efforts continue to be progressive.
Dr. Christopher added, "Unlike most medications for cardiovascular disease, this drug has been tested in a clinical trial that engaged more than 1,000 self-identified African Americans with severe heart disease. The results were impressive. A larger study is now needed in a heterogeneous population with the same clinical presentation or diagnosis -- stage 3 and 4 cardiovascular disease. It would be 'bad science' to label or market this drug as a 'Black' drug. More importantly, race-based claims are not credible in the face of modern genetic science."
Posted: June 2005
- BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients - June 23, 2005
- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure - June 16, 2005
- FDA Schedules Advisory Committee Review of BiDil - April 29, 2005
- FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date - February 3, 2005
- NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans - December 23, 2004