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THURSDAY, July 24, 2003 (HealthDayNews) -- Two leading genetic researchers have taken aim at proposed government guidelines calling for the collection of racial and ethnic data in all clinical drug trials.
The proposal, by the U.S. Food and Drug Administration (FDA), could lead to "misleading and biologically meaningless conclusions," the researchers say.
"Instead of applying social categories, we should be promoting obtaining scientific data," says J. Craig Venter, president of The Center for the Advancement of Genomics and co-author of an article arguing the point in the July 25 issue of Science. "Color of skin does not work as a surrogate."
The researchers note that several studies have shown there may be more differences in drug responses within racial and ethnic groups than between them.
Venter and co-author Susanne Haga, project director for the center, focus specifically on the FDA's "Draft Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials." The document tries to standardize information-gathering according to categories for race and ethnicity developed by the Office of Management and Budget (OMB).
"We acknowledge that these are not perfect categories, [but] the FDA is proposing that it makes sense for us to use the same categories that the NIH [National Institutes of Health], CDC [Centers for Disease Control and Prevention] and other HHS (Health and Human Services) agencies are going to be using," says Dr. John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research. "If companies collect information using different criteria, then it's hard to make a comparison between one drug and another because the information is so varied."
It also provides a way to gauge whether certain groups are under-represented in clinical trials, Jenkins adds.
Venter, however, is looking at a future in which all medicine is tailored to the individual and pharmacogenetics is king. Drugs will be selected based not only on a person's disease, but also on that person's expected response to the drug and the risk of side effects.
Researchers have the tools, Venter says, and they can get the money. "The fact that it might be hard work to get there is not an excuse. The pharmaceutical industry is spending billions of dollars doing basic research looking at genetic associations in the course of disease. The NIH has had a multi-billion-dollar budget increase to follow up on advances in medicine," Venter points out. "What's new is we have the tools. It's not as though the situation is hypothetical. We have the human genome. We have the tools now to do it."
Not so fast, the FDA responds.
"We agree that the future of medicine is probably headed toward more individualized therapy for patients, but [pharmacogenetics] is very much a science that's currently in its infancy," Jenkins cautions. "We're not ready yet to lay out criteria that tell sponsors [pharmaceutical companies] what information to collect from patients in clinical trials that will help us understand all the different [pharmacogenetic] reasons they might respond differently to. It's too early for that type of guidance to be put out."
"We are working on draft guidance on [pharmacogenetics] that hopefully will be out in the not-too-distant future that will help people understand how to report that to the FDA so we will understand how to utilize that information," Jenkins adds.
However, Stephen Thomas, director of the Center for Minority Health at the University of Pittsburgh Graduate School of Public Health, worries that Venter and his colleagues are heading down a "slippery slope of removing race as a variable in our health statistics surveillance system."
No matter how crude, the categories provide relevant information in a society where racism still exists, he says. "The idea that science is value-free and therefore immune to a social and historical legacy of American racism is incorrect. As long as that exists, I think we must count race as long as race counts," he says.
Black people have also had a negative experience with genetic research, he points out. "We're not quite confident yet that this information will not be used in discriminatory ways, whether based on race or on my gene profile or family history, especially when we do not have universal access to health care," Thomas says. "[Race] matters every day in the lives of people who face historic discrimination and that includes in the research laboratory."
More information
Go to the FDA site to view the guidelines. The National Center on Minority Health and Health Disparities has more on minority health issues.
