Race and medicine

August 02, 2005|By Troy Duster

WHEN SEVERAL African-American medical and advocacy groups urged the Food and Drug Administration to approve BiDil, a drug that purports to combat heart disease among blacks, their backing helped to clear the way for the agency to approve the application of BiDil's manufacturer, NitroMed. BiDil became the first drug approved in the United States based on race.

While hailed by many as a major step forward in medical treatment for African-Americans, the FDA's decision should be treated with a healthy dose of skepticism. This is because support for federal approval of the drug is based upon faulty science.

The clinical trials for BiDil were conducted on only 1,050 African-Americans. No other groups were studied. Thus, the research had no case controls, the gold standard of scientific work in this field. BiDil's backers have come out against this being a race-specific drug. Yet the drug's link to race was what helped ensure its approval - a mistake that might endanger more African-Americans' lives (and others') than it helps.

Here's why.

The patent for the non-race-specific compound drug called BiDil ends in 2007. But if the drug is marketed to African-Americans, the patent extends to 2020.

Therefore, while the black groups who urged FDA approval of BiDil may assert that this is not a "race drug," in the practice of countless physicians it will become so. And this is what poses a danger to African-Americans who do not need this drug and to members of other groups who might need it. Of course, in theory, a doctor can prescribe the drug to anyone. But medicine is a practice with some strong borders and boundaries when it comes to the manner in which drugs are prescribed.

Doctors and other medical practitioners typically spend no more than 15 minutes with a patient. With this short amount of time, they are likely to use phenotype - in this case, race - as a proxy for nitric oxide deficiency, a condition said to be a prime characteristic of those suffering from heart disease.

More than 100,000 deaths per year in the United States are attributable to medical error. About 11,000 of these are misdiagnosed heart problems. When doctors start using race as a proxy for a particular pattern of resonance with a drug, we can expect that number to climb, not fall.

NitroMed has noted that African-Americans ages 45 to 64 are 2 1/2 times more likely to die of heart failure than are Caucasians in the same age range. But this age group accounts for only 6 percent of heart failure mortality. In fact, after 64, statistical differences in heart failure between African-Americans and Caucasians nearly disappear.

Other existing research casts doubt on the connection between race and health risks. For instance, findings published in the journal BMC Medicine show that blacks from Africa, the Caribbean and the United States show less disparity in hypertension rates than do whites from Europe, the United States and Canada. The study also concluded that differences in hypertension rates between light- and dark-skinned African-Americans were attributed to the latter group having less access to medical and other resources in the United States.

In other words, a complex interaction feedback loop can exist between nutrition, diet and the related issues of poverty and social locations designating particular groups. Notably, rates of HIV are much more common in some groups than others, but we are at our peril in concluding that biology and genetics explain these varying prevalence rates.

The ability to use genomic knowledge to deliver effective pharmaceuticals more safely to special sub-populations that have some functional genetic markers does hold promise. FDA approval of BiDil should have been contingent upon further research to find the markers that have the actual functional association with drug responsiveness, thus ensuring that the drug would be approved for everyone with those markers, regardless of their race or ancestry.

Troy Duster is the director of the Institute for the History of the Production of Knowledge at New York University and president of the American Sociological Association.

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