perspective

“Ethnic Drugs”
B Y J O N AT H A N K A H N

A
drug called BiDil is poised to become the first drug to race, expires in 2007; if NitroMed got the drug approved
ever approved by the FDA with a race-specific indi- for treatment regardless of race, it would have only a year or
cation: to treat heart failure in African Americans. The two of patent protection. Presumably NitroMed is counting
drug itself is not actually new. It is merely a combination of on off-label prescription to non-African Americans to boost
two generic drugs that have been used to treat heart failure for the market for BiDil. Down the road, if a follow-up study
over a decade. BiDil’s newness derives primarily from its pub- shows efficacy regardless of race, then NitroMed could get
lic presentation as the world’s first “ethnic” drug. “three-year market exclusivity” from the FDA to retain effec-
The good news is that clinical findings indicate that tive control over the market for a “new indication.”
BiDil appears to be effective in treating heart failure. The Third, marketing a race-specific drug can lead to a mis-
trials, however, were conducted only in African American allocation of health care resources. This is not to advocate
patients, and the results therefore give the impression that “color blind” medicine. To the contrary, there are very real
BiDil works only in African Americans. This is not the case. health disparities in the country that correlate with race.
The trial investigators themselves concede that BiDil will African Americans suffer a disproportionate burden of a
work in people regardless of race. number of diseases, including
Without a comparison population,  hypertension and diabetes. Like
the investigators cannot even claim heart failure, these are complex
that the drug works differently in BiDil is clever marketing, conditions caused by an array of
environmental, social, and econom-
African Americans. The only
responsible scientific claim that can ic as well as genetic factors. Central
be made on the basis of these trials but bad science. among these is the fact that African
is that BiDil works in some people Americans experience discrimina-
who have heart failure—period.  tion, both in society at large and in
By seeking approval of BiDil as the health care system specifically.
a drug solely to treat African Americans, NitroMed, the cor- The question, once you identify these disparities in health
porate sponsor of the trials and owner of the rights to BiDil, outcomes, is about how to address the underlying causes. Of
has opened a Pandora’s box of racial politics without fully course, outcomes can have multiple causes, both social and
appreciating the implications of what it is doing. genetic. But health disparities are not caused by an absence
First, at a minimum, race-specific labeling will make it of “black” drugs. As studies by the Institute of Medicine
more likely that non-African Americans who would benefit among others make clear, they are caused by social discrimi-
from the drug will not get it. Health care providers simply nation and economic inequality. The problem with market-
may not think of prescribing it to non-African Americans, ing race-specific drugs is that it becomes easier to ignore the
and insurance carriers may not cover such “off-label” use. social realities and focus on the molecules.
Second, given that the BiDil researchers admit that Finally, if the FDA approves BiDil only for African
their drug will work in non-African Americans, the most Americans, it will be giving the federal government’s stamp
plausible reason for conducting a race-specific clinical trial is of approval to using race as, in effect, a genetic category. But
that NitroMed holds the rights to a race-specific patent that race is not genetic, as even the BiDil researchers admit. And
will give them control over profits from BiDil until 2020 if once we sanction such talk, it is a short step to talking about
it is approved by the FDA. Of course, this hardly constitutes races as inferior and superior. Given our nation’s troubled
a sound scientific basis for designing a clinical trial. But it’s a history of racial oppression, this is not something that
good economic one. An older patent, which does not refer should be taken lightly.
Race is a powerful and volatile category. It can be used
Jonathan Kahn teaches law at Hamline University School of constructively in medical research and practice, but it has to
Law and has recently published articles on BiDil and the use of be used with great care—more care than is evident in the
racial categories in biomedical research and drug development. story of BiDil.