"Ethnic Drugs"

A drug called BiDil is poised to become the first drug ever approved by the FDA with a race-specific indication: to treat heart failure in African Americans. The drug itself is not actually new. It is merely a combination of two generic drugs that have been used to treat heart failure for over a decade. BiDil's newness derives primarily from its public presentation as the world's first "ethnic" drug.

The good news is that clinical findings indicate that BiDil appears to be effective in treating heart failure. The trials, however, were conducted only in African American patients, and the results therefore give the impression that BiDil works only in African Americans. This is not the case. The trial investigators themselves concede that BiDil will work in people regardless of race. Without a comparison population, the investigators cannot even claim that the drug works differently in African Americans. The only responsible scientific claim that can be made on the basis of these trials is that BiDil works in some people who have heart failure—period.

By seeking approval of BiDil as a drug solely to treat African Americans, NitroMed, the corporate sponsor of the trials and owner of the rights to BiDil, has opened a Pandora's box of racial politics without fully appreciating the implications of what it is doing.

First, at a minimum, race-specific labeling will make it more likely that non-African Americans who would benefit from the drug will not get it. Health care providers simply may not think of prescribing it to non-African Americans, and insurance carriers may not cover such "off-label" use.

Second, given that the BiDil researchers admit that their drug will work in non-African Americans, the most plausible reason for conducting a race-specific clinical trial is that NitroMed holds the rights to a race-specific patent that will give them control over profits from BiDil until 2020 if it is approved by the FDA. Of course, this hardly constitutes a sound scientific basis for designing a clinical trial. But it's a good economic one. An older patent, which does not refer to race, expires in 2007; if NitroMed got the drug approved for treatment regardless of race, it would have only a year or two of patent protection. Presumably NitroMed is counting on off-label prescription to non-African Americans to boost the market for BiDil. Down the road, if a follow-up study shows efficacy regardless of race, then NitroMed could get "three-year market exclusivity" from the FDA to retain effective control over the market for a "new indication."

Third, marketing a race-specific drug can lead to a misallocation of health care resources. This is not to advocate "color blind" medicine. To the contrary, there are very real health disparities in the country that correlate with race. African Americans suffer a disproportionate burden of a number of diseases, including hypertension and diabetes. Like heart failure, these are complex conditions caused by an array of environmental, social, and economic as well as genetic factors. Central among these is the fact that African Americans experience discrimination, both in society at large and in the health care system specifically. The question, once you identify these disparities in health outcomes, is about how to address the underlying causes. Of course, outcomes can have multiple causes, both social and genetic. But health disparities are not caused by an absence of "black" drugs. As studies by the Institute of Medicine among others make clear, they are caused by social discrimination and economic inequality. The problem with marketing race-specific drugs is that it becomes easier to ignore the social realities and focus on the molecules.

Finally, if the FDA approves BiDil only for African Americans, it will be giving the federal government's stamp of approval to using race as, in effect, a genetic category. But race is not genetic, as even the BiDil researchers admit. And once we sanction such talk, it is a short step to talking about races as inferior and superior. Given our nation's troubled history of racial oppression, this is not something that should be taken...