FDA Advisory Panel Recommends Approval of Heart Failure Drug Aimed at Blacks

An FDA advisory committee on Thursday voted 9-0 to recommend approval of BiDil, a heart failure medication developed by NitroMed, for use only in black patients, a move that would, pending agency approval, make the treatment the first targeted toward a specific racial group, the Washington Post reports (Stein, Washington Post, 6/17). 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 (Kaiser Daily Health Policy Report, 6/16). In testimony on Thursday, about 12 witnesses asked the committee to recommend approval for BiDil, although many said that the "drug's availability shouldn't be directed solely" toward black patients, the Wall Street Journal reports (Corbett Dooren/Goldfarb, Wall Street Journal, 6/17). Two of the nine committee members said that the BiDil label "should not be race-specific," the AP/San Francisco Chronicle reports (AP/San Francisco Chronicle, 6/17). The other seven committee members supported a request by NitroMed that the BiDil label direct use of the medication only in black patients (Wall Street Journal, 6/17). NitroMed officials declined to comment on the committee vote (Goldstein/Simon, Miami Herald, 6/17).

BiDil Future
In the event that FDA approves BiDil for use only in black patients, physicians likely will prescribe the medication off-label to patients in other racial groups, the Boston Globe reports (Rowland, Boston Globe, 6/17). In addition, FDA approval of BiDil for use only in black patients would extend the NitroMed patent on the medication through 2020, rather than 2007 (Roylance, Baltimore Sun, 6/17). According to analysts, annual sales of BiDil could reach $825 million, provided that FDA approves the medication for use only in black patients (Saul, New York Times, 6/17). FDA likely will make a decision on BiDil by June 23, and NitroMed officials said that the medication could reach the market within one month (Wall Street Journal, 6/17).

Some Questions About Race
Committee member Vivian Ota Wang, a geneticist at the National Human Genome Research Institute, said, "What I'm hearing is that we're using race as a surrogate for a biological process. I think that inconsistency gives us a false notion that race has a biological basis, when that isn't supported" (New York Times, 6/17). "I'm not sure that skin tone is a great proxy for a biological trait," Wang said. (Alonso-Zaldivar, Los Angeles Times, 6/17). Gary Puckrein of the National Minority Health Month Foundation said, "The effort to stereotype this drug as a race drug needs to be universally decried." Puckrein has endorsed FDA approval of BiDil but not for use only in black patients. New York University sociologist Troy Duster said, "Race is too crude a measure. We should be looking at the individual and his and her biochemical makeup -- not whether he or she is black or white" (Washington Post, 6/17).

Other Comments
Committee Chair Steven Nissen said that the BiDil case "is very unusual; it is precedent-setting. But it is the case that we are moving forward to genome-based medicine. It's going to happen" (Los Angeles Times, 6/17). He added, "The evidence was not as strong as we would have liked it, but we voted unanimously in favor of approval. We got to discuss openly the ethical issues of a drug to be used in one race, and we respected the passions on both sides of the argument. But in the end it came down to the scientific evidence. The committee thought the scientific evidence was there." Clyde Yancy, a researcher involved in the BiDil study, said, "Everyone embraced the notion that we accomplished the task we set out to do. We were very careful in avoiding to say it worked only in African Americans or that it worked best in African Americans. The final language, I suspect, will likely say the drug has been proved to work in African Americans. We will probably not see a phrase that will say BiDil works only in African Americans" (Ricks, Long Island Newsday, 6/17). Charles Curry, president of the International Society on Hypertension in Blacks, said, "This is the most important advance in the treatment of black people that I have seen in my lifetime" (Washington Post, 6/17).

Broadcast Coverage
CBS' "Evening News" on Thursday reported on the panel's vote to recommend approval for BiDil. The segment includes comments from Jonathon Kahn, professor at Hamline University School of Law; Waine Kong, CEO of the Association of Black Cardiologists; and a BiDil patient who testified at the committee meeting (Kaledin, "Evening News," CBS, 6/16). The complete segment is available online in RealPlayer.

In addition, NPR's "All Things Considered" on Thursday reported on BiDil (Palca, "All Things Considered," NPR, 6/16). The complete segment is available online in RealPlayer.