'If you wanted a scientific basis for approving a race-specific drug, you would enroll more than one race [in the clinical trial]. If you wanted a commercial basis to bring BiDil to the market as a race-specific drug, then you would only enroll one race.... That may be good commerce, but it is not good science.'

At a meeting Thursday, an influential advisory committee unanimously endorsed the drug, known as BiDil, for use by blacks, who suffer disproportionately from heart failure. The Food and Drug Administration is expected to issue a final decision next week. The committee of independent experts based its decision on a recent trial in which BiDil cut the risk of death by 43 percent in a group of 1,050 black patients.

The study did not include patients of other races, which leaves doctors unsure of how well the drug would work in the broader population.

Economics Rather Than Science?

Some critics said studying only black patients was a decision based on economics rather than science. They worried that a racially targeted drug could fuel outdated beliefs about differences between the races.

But a broad coalition of groups including the Association of Black Cardiologists, the NAACP and the National Medical Association -- the nation's largest group of minority physicians -- welcomed Thursday's news.

"The simple story is the drug works to reduce the ravages of heart failure," said B. Waine Kong, executive director of the Association of Black Cardiologists. "Outside of our emotions and the history of racism in this country, that should be the end of the story."

Blacks between ages 45 and 64 are more than twice as likely as whites of the same age to develop heart failure, a disease caused by the heart's inability to pump enough blood.

BiDil is a combination of two older drugs, isosorbide dinitrate and hydralazine, that make blood vessels wider and more elastic. Both drugs were commonly prescribed for heart failure decades ago but were displaced by ACE inhibitors, the drugs now favored for treating heart failure.

'Pretty Dramatic Stuff'

Many patients in the recent study received BiDil and an ACE inhibitor, a combination that had not previously been studied. When investigators saw the combination cut the risk of death nearly in half, they halted the trial early to offer the drug to a wider group of patients.

"It's pretty dramatic stuff," said Dr. Ariel Soffer, a cardiologist at Memorial Cardiac and Vascular Institute in Hollywood, who enrolled three patients in the study. "When you see such dramatic reductions in death, there's almost a moral obligation to say something."

Soffer said the results have led him to prescribe the generic drugs that comprise BiDil to some black patients. And he would consider giving the drug combination to some patients who are not black. If the FDA approves BiDil for use in blacks, doctors would be able to prescribe the drug for any patient they deem fit.

Doctors decided to test BiDil only on blacks after reviewing studies from the late '80s and early '90s. In those studies, the drug appeared to work slightly better on black patients than on patients of other races.

But the drug has never been tested in combination with ACE inhibitors on patients who are not black. Many doctors believe it could work outside the black population.

Patent Protection

Jonathon Kahn, a medical ethicist at Hamline University School of Law in Minnesota, argued Nitromed, the company that developed BiDil, tested the drug only on blacks to extend patent protection. The company has at least two patents on the drug. One, for use in the general population, will expire in 2007. The other, for use in black patients, will expire in 2020, Kahn said.

"If you wanted a scientific basis for approving a race-specific drug, you would enroll more than one race [in the clinical trial]. If you wanted a commercial basis to bring BiDil to the market as a race-specific drug, then you would only enroll one race because you ensure, that if it is shown to work, it will be shown to work in just one race," he said. "That may be good commerce but it is not good science."

A company spokesman would not comment Thursday, citing the pending FDA approval.

Carol City resident Theresa Jones, 61, who has suffered from chronic heart failure for 27 years, participated in the BiDil study: "If it helped me, I am quite sure that it will help a lot of . . . African Americans."

-- By Jacob Goldstein and Darran Simon