That there could be race-specific drugs has alarmed some in the medical profession who say race is not a true category for classifying biological differences. But other physicians, who say the drug can save lives, applaud Thursday's decision by the FDA advisory committee.

"The approval of BiDil represents a significant advance in the therapy of heart disease, especially for African Americans," said Dr. Michael Hess, a cardiologist at VCU Medical Center.

VCU was one of 172 sites around the country that participated in BiDil phase three clinical trials. VCU enrolled about 18 people in the study, called the African American Heart Failure Trial, said Hess.

NitroMed Inc., of Lexington, Mass., makes the drug.

'Results Were Dramatic'

In the study, BiDil was added to existing medication regimens of some patients, while others got a placebo, or dummy drug, added to other drugs they already were taking.

Because of the promising results, the study was stopped early. In all, 1,050 patients were enrolled.

The drug had been studied earlier in a broader population, but the results did not show any significant benefit.

In the study of black patients, "the results were dramatic," said Hess. "The company is ready to get the drug distributed to the market June 23."

The FDA will consider its advisory committee's recommendation next week. Hess believes it is almost certain to be approved.

"It gives an additional form of treatment over and above what was available," Hess said. "It really was an add-on drug. The addition of this drug, in this particular group of patients, resulted in significant improvement in survival. That is the real bottom line."

In heart failure, the heart pumps poorly, so that blood flow is not what it should be. Heart failure is usually a disease of old age, often a complication of coronary artery disease or high blood pressure, but it can and does happen to younger people, often as the result of congenital heart defects.

Data suggest African Americans suffer higher rates of heart failure and come down with it earlier than other racial or ethnic groups.

'Improves the Quality of Life and Survival'

Even so, skeptics say inserting race in this way in medicine is misguided. They say race is not a true measure of biological differences.

It is true that different groups of people respond differently to drugs, Dr. Jonathan D. Moreno, director of the Center for Biomedical Ethics at University of Virginia Health System, has said previously when asked about BiDil.

"Unfortunately the way people identify the groups that are likely to respond differently to different drugs is so unreliable that you hate to see it become set in stone," Moreno said.

A more studied approach, Moreno explained, is the focus of an international effort seeking to identify genes that are passed down in different groups and that predispose people to disease and to respond differently to treatments.

Hess said the criticism partly misses the mark.

"If I [had] a form of therapy that could significantly help sickle-cell disease, there would be no question about it," Hess said. "Here, it's the same analogy. Here is the disease of hypertension and heart disease. The current therapy for African Americans is not as good. Here is a drug, when added, that significantly improves the quality of life and survival."

According to NitroMed, adverse effects seen more frequently in study participants taking BiDil included headache and dizziness.