Panel backs drug for blacks
BiDil heart treatment is 1st aimed at specific race; FDA expected to give OK
A federal panel yesterday recommended approval for the first prescription drug promoted on the basis of racial ethnicity: BiDil, a cardiovascular drug for African-Americans.
The unanimous vote by an advisory panel of the Food and Drug Administration was a major victory for the drug's sponsor, NitroMed Inc., a Lexington biotechnology firm that does not have any drugs on the market.
The FDA rarely overturns recommendations of its advisory panels and might approve BiDil as early as June 23. One analyst said the drug -- a combination of two widely available generic products -- could generate more than $500 million a year in sales.
''If approved by the FDA, BiDil will provide new hope to black heart failure patients who suffer a disproportionate burden of this disease," said Manuel Worcel, M.D., NitroMed's chief medical officer, in a statement after the vote.
The panel's recommendation left out a provision that NitroMed had sought that would restrict prescriptions to blacks. Doctors said in interviews yesterday that, even if the FDA decides to restrict its use to African-Americans, they expect doctors to also write prescriptions to whites. Physicians are permitted to write such ''off-label" prescriptions if they believe their patients will benefit.
Trading in NitroMed stock was suspended yesterday during the panel's deliberations, so the effect of the 9-to-0 vote will not be felt until markets open today.
The recommendation represented a rudimentary first step toward the future of medicine, which scientists say will feature pharmaceuticals genetically tailored for individual racial groups and other sub-populations. The prospect of BiDil's approval also generated the ethical questions that will accompany such advances. Some wonder if such customized medicines will affect how physicians, insurance companies, and patients perceive racial differences.
''That door is going to open with unknown repercussions," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
NitroMed's clinical trials showed that BiDil reduced the death rate in African-Americans treated with the drug by 43 percent, compared to African-Americans treated with the standard regimen of heart drugs plus a placebo.
Blacks suffer almost twice the incidence of heart failure than whites, so it is encouraging to find a drug that appears to give blacks a special benefit, said physicians who treat large numbers of African-American patients.
''There is definitely a gap in treatment for heart failure," said Dr. Theodore Addai, clinical chair of cardiology for Meharry Medical College in Nashville and a board member of the Association of Black Cardiologists, which supports FDA approval of the drug.
But critics of NitroMed's application portrayed it as a salvage effort for a marginal drug, not a leap toward the frontier of ethnically tailored medicine.
They noted that the treatments combined to make BiDil are already available in the form of cheaper generics.
''They're throwing two old drugs together, getting a patent on the combination, calling it a new drug, and charging a lot more for it," said Marcia Angell, a former editor of the New England Journal of Medicine and a frequent critic of drug industry practices. ''It's just a new way to get a patent. There's nothing innovative about that."
An assistant professor of sociology from New York University, Ann Morning, said BiDil raises profound issues about how society perceives the cardiovascular health of African-Americans. ''It's going to detract from attention to things like socioeconomic status, residential patterns of segregation, different diets, stress from discrimination," she said. ''A drug is a silver bullet, and we don't think about the social factors involved."
BiDil was once an unlikely candidate to trigger these types of debates. It is not a genetically designed compound and it failed to impress regulators in the 1980s when it didn't appear to help patients in a sample of the total population that included various ethnic groups.
NitroMed came up with a fresh strategy. It searched through old trial data, found indications that it benefited a sub-group of blacks, and pushed it through a new round of development and regulatory reviews. Those reviews only included black patients.
Why BiDil appears to work better in blacks is unknown, scientists and doctors said.
''We do know that race is just a very crude marker for something, we just don't know what that something is," said Dr. B. Waine Kong, executive director of the Association of Black Cardiologists.
The best theory among researchers, he said, is that is that BiDil compensates for a nitric oxide deficiency, which is more prevalent among African-Americans.
NitroMed would not discuss yesterday what it would charge for the drug. JP Morgan Chase & Co., which developed the revenue projection of more than $500 million a year, estimated the cost of taking BiDil at $1,460 a year initially, rising to $1,776 within five years.
The price will be key to winning favorable treatment from insurance companies. If it is too high, the drug could be excluded or placed unfavorably on lists called ''formularies," because generic versions are available. It would cost about $810 to buy a year's worth of the two drugs used in BiDil through the Internet pharmacy, Drugstore.com.
BiDil's key ingredients are the generic medicines isosorbide dinitrate and hydralazine.
Christopher Rowland can be reached at firstname.lastname@example.org. Material from Bloomberg News was used in this report.