FRIDAY, June 24, 2005 (HealthDay News) -- The milestone approval of the first drug geared specifically to blacks has raised questions about intertwining race and biology while addressing the very real health concerns of minorities.
"On the one side, we have a history of ignoring ethnic minorities' health concerns in this country. For many years, they were either not included in large-scale health studies or they were exploited," said Celia Fisher, director of the Fordham University Center for Ethics Education in New York City. "But different ethnic groups do have different health-care needs."
Heart failure is a prime example. The condition, in which the heart loses its pumping ability, affects approximately 5 million Americans, including an estimated 750,000 blacks. But blacks aged 45 to 64 are two-and-a-half times more likely to die from heart failure than whites of the same ages.
The FDA stressed just that point Thursday in approving BiDil as the first-ever race-based treatment for heart failure.
"Today's approval of a drug to treat severe heart failure in self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients," Dr. Robert Temple, FDA associate director of medical policy, said in the approval announcement letter.
No one went looking for a drug to treat heart failure specifically in one race, however. BiDil was sort of a happy accident.
It is actually a combination of two older drugs -- hydralazine, an anti-hypertensive agent that relaxes the arteries, and isosorbide dinitrate, an anti-anginal agent that relaxes the veins and arteries. Neither was approved for heart failure before clinical trials began. And it is still unclear how the two drugs work together.
But trials of the drugs that were conducted in the 1970s and 1980s did show a benefit for black patients, even though no overall benefit was found.
A new trial, the African American Heart Failure Trial (A-HeFT), was designed to look specifically at the effects of BiDil in 1,005 black heart patients.
A-HeFT found a 43 percent reduced risk of death, 39 percent reduction in risk of first hospitalization and improved quality of life among those taking BiDil plus standard heart failure therapies, compared to those taking only standard therapies.
The trial was stopped early in July 2004 because of the significant survival benefit.
The bottom line for many experts is that the drug, manufactured by NitroMed Inc., of Lexington, Mass., works.
"Some people are concerned about race being used as a target for medical therapy, but African-Americans really die at a much higher rate than their non-black counterparts from heart failure," said Dr. Paul Underwood, president of the Association of Black Cardiologists, which co-sponsored the trial leading up to the drug's approval. "[With BiDil], there actually is an improvement."
"It's clearly a major medical moment, one that in many ways promises to help begin addressing the disparities in health care among African-Americans," added Luvon Roberson, a long-time communications consultant to the health-care and pharmaceutical industries. "Research clearly shows that physicians tend not to offer African-American heart patients the most aggressive treatment. This has the potential to make a difference."
"This is one of the most important studies we've done in a very long time," said Dr. Hector Ventura, acting head of the cardiomyopathy and heart transplantation center at the Ochsner Clinic in New Orleans. "If you really want to know what a drug will do in a particular population, the best way is to study it in a particular group. It works."
"The issue of how you define African American and what that means, that's a different story," he continued.
What's controversial about the approval is a concern that the difference in disease burden will start to be attributed to genetics, a premise that could have a long, slippery slope.
"The downside is if people begin to assume that because it works in a particular minority group that it's a genetic issue," Fisher said. "As human beings, we share 99.9 percent of all our genes across race, and we haven't been able to identify genes that define race, outside of skin color."
"It's great if we tailor medication to them. It's not good if we then assume that there's a genetic difference," she added.
In fact, no one yet knows why blacks suffer a larger burden of heart failure or why BiDil works better for them.
"We don't think at all that race is necessarily a genetic marker or that BiDil has any specific genetic effect," Underwood said. "We're trying to tease out the nuances of genetics that make African-Americans more responsive."
According to Underwood, blacks are more likely to have heart failure from hypertension and whites are more likely to have heart failure from coronary artery disease. "The different causes of heart failure may make some difference, but we don't know," he said.
And it's also possible that the drug might also benefit people of other races. "Don't assume that just because somebody is African-American that this drug is going to work better for them," Fisher said. "And don't eliminate non-African Americans from being able to have that drug. If we stop looking at the reasons why it works in African-Americans, we may be hurting non-African Americans who could benefit from them."
Following the approval of BiDil, some ethicists have said that making medical decisions based on someone's race has no more biological relevance than making such decisions based on someone's religion.
"If Catholics were dying at twice the rate as Protestants and something was able to help Catholics live longer, then I think Catholics would want it approved," Underwood replied.
The National Minority Health Month has more on heart failure in blacks.