FDA Approves Heart Failure Drug for Use in Black Patients
FDA on Thursday approved BiDil, a heart failure medication developed by Massachusetts-based NitroMed, for use in black patients, a "controversial step toward a new frontier of personalized medicine," the New York Times reports. BiDil marks the first medication approved by FDA for use in a specific racial group. In a recent study, BiDil reduced the risk of heart disease in black patients. In the study, which involved 1,050 black patients with moderate to advanced heart failure, half of participants received BiDil, a combination of the heart disease medications isosorbide dinitrate and hydralazine, and half received a placebo.
After three years, 32 participants who received BiDil died, compared with 54 who received a placebo, the study found. In addition, the study found that the number of first hospital admissions for heart failure among participants who received BiDil was 33% less than the number among those who received a placebo (Saul, New York Times, 6/24). According to FDA spokesperson Suzanne Trevino, the BiDil label will state that the medication is effective in self-identified black patients but has not proven effective among other racial groups (Roylance, Baltimore Sun, 6/24).
However, physicians likely will prescribe BiDil to patients in other racial groups as an off-label use, according to Flora Sam, who led a BiDil study at Boston Medical Center (Henderson, Boston Globe, 6/24). NitroMed has not announced the price of BiDil. NitroMed officials said that they will begin to market BiDil almost immediately and that sales representatives will focus on physicians who treat a large number of black heart failure patients (New York Times, 6/24).
Robert Temple, FDA associate director of medical policy, said, "The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition" (Freking, AP/San Francisco Chronicle, 6/24). Temple said that BiDil "is a striking example of how a treatment can benefit some patients even if it does not help all patients." He added, "In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil" (Corbett Dooren, Dow Jones/Wall Street Journal, 6/24).
Roger Blumenthal, director of preventive cardiology at Johns Hopkins Hospital, called BiDil a "major step forward," adding, "What we'll probably learn in the next few years is what genetic variations make certain medicines work better in some individuals than others" (Sternberg, USA Today, 6/24).
Winston Price, president of the National Medical Association, said, "It is our hope that BiDil will be brought to market as quickly as possible to enhance its lifesaving impact. Any day of delay represents an unacceptable missed opportunity to save lives." NMA also said that researchers should expand BiDil studies to include heart failure patients in other racial groups (AP/San Francisco Chronicle, 6/24).
Steve Nissen, who chaired the FDA advisory committee that recommended approval of BiDil, said, "I hope what it does is refocus physicians' attention on the fact that African-American patients with heart failure respond differently to drugs. It's not a one-size-fits-all approach" (Boston Globe, 6/24).
David Magnus, director of the Stanford Medical Center for Biomedical Ethics, said, "There are many, many who claim these use[s] of racial categories may not have any biological meaning, only social meaning, and basing medical decisions on them may be problematic. ... But the more we know genetically, the more we know these social categories don't correspond to genetic groups" (AP/San Francisco Chronicle, 6/24).
According to Lawrence Brody, a geneticist at the National Human Genome Research Institute, "It may be that if this (BiDil's effectiveness) is a race-specific response, it is unlikely to be due to any genetics because people of African origin are extremely diverse" (Baltimore Sun, 6/24).
M. Gregg Bloche, a health law and policy professor at Georgetown University, said, "It invites people to think there are significant biological distinctions between racial groups when in fact the evidence shows nothing of the sort. There's a risk of casual thinking that can shade over into discrimination -- there's a substantial risk" (Stein, Washington Post, 6/24).