Dark Skin, Take This Pill; Light Skin, Take That One

African Americans and Caucasians may respond differently to some cardiovascular medicines, according to clinical trial data. Last year for example, the Food & Drug Administration approved BiDil, a drug for the treatment of heart failure in self-identified black patients. On store shelves now are "genetic-specific" vitamins aimed at different races. Is developing a class of race-based drugs the next stop on the train ride to personalized medicine?

Not necessarily, says M. Gregg Bloche, who specializes in health law studies. "Here, I think race is just part of the landscape of regulatory and other economic incentives."

Historically, pharmaceutical companies have reformulated drugs coming off patent in some way to obtain a new patent, by making a long-acting drug into a short-acting one, for example, or changing the drug?s delivery system or reframing its recommended use.

"Race happened to be the opportunity this time around," Bloche says. He acknowledges some possible biological reasons to suspect a stronger response to certain cardiovascular drugs among African Americans than among Caucasians, "leaving aside the thorny problem of how you define an African American." But he doubts that scientists or medical doctors are targeting drugs to race. "I think it was an economic decision by pharmaceutical firms; they saw the opportunity to make race a factor and design trials accordingly," he says. A focused trial population also means small, less expensive clinical trials.

Bloche holds both law and medical degrees and is currently examining the roles of medicine in the public sphere at the Economic Studies Program of the Brookings Institution, in Washington, D.C. A professor of law at Georgetown University and an adjunct professor at the Johns Hopkins University Bloomberg School of Public Health, he won a Guggenheim Fellowship for 2005 and 2006.

What does Bloche suggest to get more bang from the pharmaceutical buck in the future? The best drugs come from improved understanding of physiology, he says, and the research to provide that understanding doesn't come from drug companies. "What is clear is that when breakthroughs occur, it's because the basic science?almost without exception?gets done in laboratories that are either financed by private foundations supporting basic science research or that are financed by public sources, such as the National Institutes of Health or the National Science Foundation.

"Drug companies, on their own, are really unlikely to make those kinds of scientific advances," he continues. "They have incentive to invest in applied research, research that is really close to bringing a product to market." And they do that work well, he adds.

Bloche says the medical community will have to make do with the drugs and the data created by clinical trials financed by pharmaceutical companies. Changing the situation would require "a wholesale commitment publicly as a country to the public financing of clinical trials." Publicly financed trials would be expensive but could facilitate other important changes, such as getting proposals for clinical trials peer-reviewed by committees of research physicians who were screened for conflict-of-interest problems, he adds.