MEDICINE Drug study targets blacks

The experimental medication would be the first designed for a specific race.
WASHINGTON POST
OAKLAND, Calif. -- Three times a day, nine patients at General Hilliard's popular private clinic here take a tiny orange pill for their heart troubles as part of a nationwide study that some describe as the future of drug treatment and others call medical heresy.
The diverging views stem not from what the experimental drug contains but who is allowed to take it -- only people who identify themselves as black.
The hope is to create the first prescription medicine intended for a specific racial group. The pursuit of such a treatment, however, has become the subject of impassioned debate and research in the medical community.
As more new drugs are made to attack disease based on their genetic origins, doctors are divided over whether race or ethnicity should play a role in treatment decisions. And, if so, there is this practical question: In a world of mixed heritages, how does a doctor even determine a person's race?
"The more we learn about how drugs work the more we see a genetic component, and the race question is among the biggest mysteries," said Hilliard, who has been practicing cardiology for nearly three decades.
Few genetic differences
The notion of race was advanced centuries ago as a method of social and political grouping when new transportation methods allowed people from far-flung parts of the world to regularly interact withone another. The divisions often were drawn by the superficial: skin and hair color, shape of the eye.
However, recent advances in genetic mapping have all but dismissed race as a biological construct. Race accounts for only a tiny amount of the 0.1 percent genetic variation between one human and other. That means that someone who is considered black, for instance, might have more genes in common with someone who is white rather than someone who is also black.
Yet, on the other hand, science also has shown that certain groups share inherited traits, and often similar ailments.
The Food and Drug Administration gave biotech start-up NitroMed Inc. the green light to study whether its drug should be approved for use in a single racial group. NitroMed is testing its therapy at 160 sites on what it hopes will eventually be 1,100 patients. Results could be announced in as soon as a year.
Though some doctors have for a long time adjusted dosages or favored certain medications over others because of a patient's race, government approval of the NitroMed drug would be the first time a drug has been sanctioned specifically for use in one racial or ethnic group.
Increased interest
The tests come as interest grows in the medical community over the possibility of race-based treatments. The FDA issued guidelines this year on how racial information should be collected in clinical trials. And a few months ago, doctors and researchers in the New England Journal of Medicine debated the issue in a special section of the influential publication.
Recent drug test results have suggested some promising but inconclusive trends: Tests of an AIDS vaccine made by Brisbane, Calif.-based VaxGen Inc., for instance, seemed to show that it was a failure in whites but might have some promise in blacks and Asians.
The breast cancer drug Tamoxifen, by British pharmaceutical giant AstraZeneca PLC, seemed to be a bit less effective in blacks than whites.
Some experts argue that the sample sizes were too small to draw any real conclusions and that if the analysis was done another way, no racial differences would be found. Nevertheless, some doctors have seized on such data to tailor their treatments by race, switching drugs or changing dosages. They say that although race may be an imprecise measure of people's genetic reaction to drugs, it is the best proxy for such a correlation available now.
"Ignoring racial and ethnic differences in medical and biomedical research will not make them disappear," Esteban Gonzalez Burchard, an assistant professor at the University of California at San Francisco, concluded in a recent journal article he wrote with others.
Opposing view
Critics, though, say promoting certain drugs for race-specific markets could lead to stereotyping and discrimination. They say racial categories are more a societal construct than a scientific one.
The FDA has advised researchers to use the same race and ethnicity groupings as the U.S. Census, categories that resulted to a large extent from political lobbying.
"I think it's just bizarre, marketing a drug just to people who are black. The scientific evidence supporting the notion that there's a differential response in race is weak or nonexistent," said Richard Cooper, chairman of the preventive medicine and epidemiology department at Loyola University in Illinois, who has written extensively about race and medicine.