"The reason they turned [the earlier bid] down was not because they didn't think BiDil worked," said Jonathan Kahn, a law professor at Hamline University in Minnesota, who wrote an article for the Yale Journal of Health Policy, Law and Ethics about the history of BiDil and the controversy surrounding race-based treatments.
The problem was, said Kahn, researchers didn't design the trial to meet the kind of tests the FDA applies when new medications are submitted for approval. Taylor said researchers were conducting exploratory research -- to see if the drug, as theorized, might decrease the heart's workload, thereby helping it pump more efficiently.
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Researchers later reanalyzed the data and found that black patients seemed to respond more favorably to BiDil than did whites. They published a study in 1999 in the Journal of Cardiac Failure that combined the results of two heart failure trials involving 395 black men and 1,024 white men. In one of those trials, black men taking the two components of BiDil had a slightly lower mortality rate than those on placebo; white patients taking the drugs saw no effect. The authors called for additional trials "involving large numbers of black patients" to further investigate their response to the drugs.
The data reported in the most recent study means almost certain FDA approval for BiDil use in black patients, doctors said. That expected approval would allow NitroMed to hold exclusive rights to the drug until 2022. The earliest BiDil could be on the market would be sometime in 2005.
But Kahn said the drug did not have to be tied to race to be approved.
"You come to realize how really terribly unfortunate it is that it [BiDil] became entangled with race, and that race -- in my mind -- is really being used here much more as marketing concept than as a medical concept," Kahn said. "And that's my real concern."
Taylor said she expects that other racial groups will benefit from BiDil as well. "We think that there will be [positive] effects in other groups of patients. What you need are sizable groups [in clinical trails] to show that," she said.
Without such proof, doctors said, official FDA approval will not likely be broadened. That means doctors wanting to use it for patients of other races will have to prescribe it "off label" -- the term for uses not specifically approved by the FDA, said M. Gregg Bloche, a Georgetown University law professor and an adjunct professor at the Johns Hopkins School of Public Health.
But identifying good candidates for BiDil by race could be tricky, said Bloche, since many people have backgrounds that include several different ethnicities. Color of skin, he said, is not an accurate marker of racial background.
"The concept of race is based on a tiny number of genetic characteristics," said Bloche. What matters more, Bloche said, are specific genetic patterns that affect how people respond to medications and other therapies. Members of any number of races may have these genetic characteristics. Environmental factors can make a difference, too, he said.
Kahn, the author of the study criticizing the association between BiDil and race, also expressed discomfort with the new study.
"It sends the message that because it was done only in African Americans that somehow African Americans are different genetically than everybody else. And that is a very dangerous message to be sending," Kahn said. "It's one that doesn't need to be sent in order to bring this drug to market."