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Dr. Theodore Addai, chief of cardiology at Nashville General Hospital and Meharry Medical College

The Food and Drug Administration on June 23 approved BiDil, a drug treatment for cardiovascular disease that specifically targets blacks. In a statement, the FDA says the drug represents "a step toward the promise of personalized medicine."

"Today's approval of a drug to treat severe heart failure in the self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients," says Dr. Robert Temple, FDA associate director of medical policy. "The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition. In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil." A Food and Drug Administration advisory committee endorsed the drug on June 16.

Dr. Theodore Addai, the chief of cardiology at Nashville General Hospital and Meharry Medical College, calls approval "a great step forward in the management of heart failure." Addai headed one of the 170 sites across the nation where BiDil was studied as a therapy for blacks diagnosed with heart failure. The Phase III clinical trial, launched in May 2001, was abruptly halted in 2004 because the findings so far had been overwhelmingly positive - an astounding 43 percent reduction in death rates. Cessation allowed the study participants who were taking the placebo to benefit from BiDil as well.

"Based on the data we currently have available, BiDil appears to be either not effective or less effective in whites," Addai explains.

The FDA's Cardiovascular & Renal Drugs Advisory Committee voted unanimously to approve BiDil for treatment of heart failure. All but two members agreed that the indication should be restricted to African-Americans. Committee consultant Vivian Wang with the National Human Genome Research Institute voted against labeling BiDil for blacks, saying the drug's effect in blacks is biological not racial and the recommendation "will be over-interpreted," according to committee releases.

Yet Committee Chairman Steven Nissen with the Cleveland Clinic said the data presents a "compelling argument, but only for this population" of self-identified African-Americans. "I find the evidence is more than adequate to vote for approval," he said.

The Sunday, June 19, New York Times on its editorial page raised "troubling questions" about the impact BiDil's approval might have on how drugs are tested. The Times contended that qualifying a drug as a racial medicine rather than a broader-based therapy would require smaller - and thus less expensive - studies. "Regulators need to find some way to ensure that drugs of potential value to everyone are tested broadly," The Times said.

Approximately 1,050 African-American men and women were enrolled in the BiDil study, nine in Nashville. The trial was designed as a randomized, double blind, placebo-controlled study, which means that neither the patients nor the investigators knew which patients were receiving BiDil and which were receiving a placebo. The study enrolled blacks with moderate to severe heart failure whose hearts don't pump blood efficiently.

BiDil is a combination of two older drugs, hydralazine and isosorbide dinitrate, which was studied in the 1980s as a therapy for heart failure in the general population. The combination was shelved after mediocre study findings. Yet, when a researcher years later reanalyzed those results, taking a look at racial disparities, the findings yielded promising data for the African-American participants. Because the FDA wouldn't consider the drug combination based on a retrospective analysis, the new study was launched.

The death rate from heart failure is twice as high in African-Americans as compared to Caucasians. Addai says studies show that blacks don't have as much nitric oxide in their bodies as they need, and whites don't suffer from this deficiency. Because BiDil is a nitric oxide enhancer, blacks may thus glean an added benefit from the drug. Nitric oxide allows the blood vessels to dilate properly and promotes the normal pumping action of the heart.

Addai says with this FDA approval he will use BiDil as a standard therapy for blacks and reserve it for whites who are not responding to standard therapy. "The only obstacle I see is that, since it's approved specifically for blacks, we may have some insurance companies that want a preauthorization before it can be used in whites. That might be an obstacle," he notes.

BiDil's developer is NitroMed Inc., an emerging pharmaceutical company based in Massachusetts. The company specializes in the discovery, development and commercialization of proprietary pharmaceuticals based on the therapeutic benefits of nitric oxide.

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