Since being approved by the U.S. Food and Drug Administration in June, BiDil, the first drug marketed specifically for treatment of heart failure among African Americans, has aroused suspicion about its safety and set off a debate about attitudes surrounding race and medical research.
In clinical trials, BiDil reduced deaths by 43% and decreased hospitalization by 39% among African American heart failure patients. It also reduced heart failure symptoms. The trials were halted after results showed a significant survival benefit. Researchers are uncertain why the drug works better among blacks than other races.
Although preliminary results were successful, some in the African American community say the marketing of BiDil may expand this move toward personalized medicine and increase the number of race-specific drugs in the marketplace.
“We need to understand the biology of this drug and the genetic basis under which this drug works and the people it would apply to. We feel very strongly that those individuals would not be limited to the people we call black or African American,” says Charles Rotimi, Ph. D., director of the National Human Genome Center at Howard University in Washington, D.C.
Furthermore, adds Rotimi, the notion of a race-specific drug will give the impression that the biology of black people is different than others. Historically, says Dr. Winston Price, former president of the National Medical Association, clinical trials and drug research have focused on white males, which may contribute to health disparities among whites and other races. But limiting studies solely to blacks is equally amiss, claims Price. “The A-Heft trial showed the medication to be effective in treating severe heart failure. More than 1,000 African Americans in the trial showed significant improvement with the drug,” he said. “Lack of diversity in the makeup of the subjects and researchers in clinical trials limits the ability to address and eliminate health issues.”
More than 5 million Americans, 750,000 of whom are black,
suffer from heart failure, a highly fatal condition that weakens the heart and prevents it from pumping enough blood. The FDA originally rejected BiDil, when it was submitted for approval in 1997 as a generic drug for treatment of heart failure, citing there was no conclusive evidence showing it was effective. But in a controversial move, the FDA approved BiDil — which drugmakers claim allows the heart to pump easier by relaxing blood vessels — for self-identified African American patients, marking the first ever ethnic drug to hit the market.B. Waine Kong, CEO of the Association of Black Cardiologists Inc., which co-sponsored the BiDil study, says clinical results back the marketing of BiDil among African Americans. “I’m aware of the issues that BiDil has raised, but if a medication works, what’s wrong with that? It doesn’t mean we won’t stop monitoring the drug to see its effect on the black community.”
Charmaine Royal, Ph. D., director of the GenEthics
Unit at the National Human Genome Center, says despite BiDil’s initial success, African Americans should not be treated as a monolith when it comes to drug therapy. “I see the ethical issues intertwined with the scientific issues. There is no justification, on the basis of science, to assume that a drug will work for all people in a particular ethnic or sociodemographic group, and race makes the assumption that everyone in a group is the same. Based on what we know about human genome variation, a drug will not work for everyone in a particular group and there are people in other groups for whom it might work.”There are also economic issues, claims Royal, which are not being widely discussed, namely that NitroMed Inc., BiDil’s manufacturer, has a monopoly on this patent, which was due to expire in 2007 but has now been extended to 2020 as a result of the drugmaker re-marketing BiDil for use among African Americans.
Another issue is cost. BiDil sells for $1.80 per pill, far more than generic drugs at 30 cents a pill. But William “BJ” Jones, NitroMed’s vice president of marketing, says no one will pay retail price. “BiDil will be free for people whose income is under the poverty level.”While Jones and others marketing new drug treatments see a big future in personalized medicines, those in the medical community who remain skeptical of ethnic drugs say long-term research will be the true determinant. “I don’t think it’s going to evolve at a pace that might increase the number of available drugs for select populations because of the negative feedback that has arisen, particularly among constituents who currently control the purse strings for research.” says Price. “I think it will continue to be a topic of discussion for the next five to 10 years, but will move slowly in terms of turning out research-based clinical trials that is race-specific.”