A prescription for participation: diabetes study helping African Americans overcome fears of ethnic medical research

Black Issues in Higher Education, Dec 11, 1997 by Eric St. John

They don't want to take pills. They're unwilling to participate in randomized trials. They are reluctant to take a chance," says Robert Ratner, M.D., head of the Medlantic Clinical Research Center in Washington, D.C., discussing why some people don't want to participate in medical research. "There remains reluctance to participate in any medical study. Some of it is, `I want someone else to do it so I "know it's safe, then I'll do it' -- the guinea-pig phenomenon."

Historically, the level of participation of African Americans in medical research studies has been modest. Wary of the motives of those conducting the research -- especially in light of the Tuskegee syphilis experiment -- Blacks have tended to shy away from men and women in lab coats.

That may be changing however, and an example of that change is the National Institutes of Health's (NIH) diabetes study.

NIH is conducting the study -- called the Diabetes Prevention Program (DPP) -- at twenty-five sites around the country. The purpose of the study is to examine ways to prevent type 2 diabetes -- a disease which is developed over time in adults and which causes inadequate processing of sugars in the body.

An important aspect of the study is the mandated participation of minorities. Guidelines for institutions conducting the research state that half of the participants are to be minorities. To accomplish that, community fears about past research studies had to be assuaged.

"There is a reluctance to participate [in medical research studies] in all ethnic groups," says Ratner. "They have some very real concerns. For instance: To what extent is the research explained?; Will it be relevant to them?; And are the goals of the program acceptable? People will not go into a study that they don't understand or trust."

Recalling the History

Medical research studies have often been problematic for minorities. In fact, some of the studies regarding African Americans had very little to do with real medical research. In the nineteenth century, Sen. John C. Calhoun of South Carolina cited statistics from the 1840 U.S. Census as proof that free Blacks were more likely than slaves to be mentally defective.

Samuel A. Cartwright, a New Orleans physician and contemporary of Calhoun's, also offered "proof" that Blacks were inferior to Whites based on anatomical and epidemiological surveys.

Perhaps the most infamous research affecting African Americans was this century's Tuskegee syphilis experiment. In that case, the federal government withheld a syphilis cure from hundreds of male participants in a study that lasted four decades. President Bill Clinton formally apologized for that experiment last spring.

When news of what actually occurred during the Tuskegee syphilis experiment was made public, it had a chilling effect on African American participation in medical research in this country.

"Because of the way research has been carried out [in the past]," Ratner says, "there is concern. The Tuskegee experiment has had an effect on that."

African Americans aren't the only minorities leery of ethnic medical research. The Jewish community, for example, has had its problems with the lab-coat set. Nazi Germany's genocidal use of Jews for scientific experimentation is well documented. The recent discovery of a cancer gene that is found in one of six Jews of Eastern European ancestry but virtually absent in non-Jews is causing some consternation within the Jewish community.

And research on women's health problems has been said to be too male-oriented and male-dominated in its approach and conclusions. Drug companies have kept women of childbearing age out of such studies because of worries that some drugs may harm a fetus if the participant were to get pregnant. In September, the Food and Drug Administration proposed a regulation that would force drug companies to include more young women in studies of new medicines.

Tracking minority participation in medical research has been a difficult, and tricky, endeavor. NIH -- which is expected to fund approximately 27,000 studies in 1998, according to Lorrita Watson, M.D., of NIH's Office of Research on Minority Research -- does not count the number of medical research projects aimed at minorities. Instead, it looks at the dollars which go to particular institutions. And even then, it has no clear definition as to what is minority research and what is not.

"We try to accumulate the dollar amounts given to minority institutions to decide which research pertains to minorities," says Watson. "But then we run into the problem of trying to decide [if] more than 20 percent makes it a minority study, or is it 50 percent?"

As for the amount of NIH money historically Black colleges and universities (HBCUs) receive, Watson estimated that for the past five years, "HBCUs have gotten about 1 percent of the money NIH gives to higher education institutions."

According to Terrence Herron, the director of the Program Budget Branch of NIH's Office of Financial Management, the institute spent $12.7 billion on medical research in 1997. Of that, $8.46 billion went to higher education institutions. HBCUs received $79.8 million -- less than 1 percent -- of NIH's higher-education pie in 1997. The only HBCU involved in the current diabetes study is Howard University in Washington, D.C., which is collaborating with Medlantic.