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A prescription for participation: diabetes study helping African Americans overcome fears of ethnic medical research
By Eric St. John
Jul 12, 2007, 04:40

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.

Additionally, a particular research project may not be considered a minority study simply because the condition being studied disproportionately affects minorities.

"For instance," says Watson, "we know that Black males have a higher rate of prostate cancer, but that doesn't mean all studies on prostate cancer are necessarily aimed at Black males."

One area of research that has been aimed at African Americans has been in sickle cell disease, which affects African Americans almost exclusively. A recent sickle cell study was ended a year early because doctors wanted to make their findings and a newly discovered treatment, which involves replacing the blood system of the anemic victim, available to the public.

What Is Minority Research?

Until recently, according to Watson, NIH was unable to determine minority participation in medical research because there was no central repository set up to sift through information from the tens of thousands of studies conducted by NIH each year. It wasn't until 1994 that NIH formally established guidelines on the inclusion of minorities and women as participants in research and clinical trials. Funding was tied to compliance with the guidelines, and as a result, monitoring was required.

According to data from an NIH report released in May, in 1994, 17.5 percent of the participants in NIH Phase III clinical investigations -- studies usually involving several hundred or more subjects -- were African American, 6.7 percent were Hispanic, 1.8 percent were Native American, and less than 1 percent were Asian American. Whites were 57.8 percent of the participants, and the racial identity of 15.4 percent was unknown.

Because such data was only mandatory from those involved in Phase III research, a complete accounting of NIH's, 1994 studies is unavailable. However when using data from all the institutions that did respond, minority participation rose: 23.3 percent African American, 8.9 percent Hispanic, 3.9 percent Asian American. By this criterion, Native American participation dropped to 1.1 percent and White participation fell to 52.3 percent. Only 10.6 percent remained unknown.

The report, Implementation of the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, was produced by NIH's Office of Research on Women's Health, which is directed by Vivian W. Pinn, M.D., former chair of the Pathology Department at the Howard University School of Medicine.

But despite the apparently improving numbers and medical breakthroughs -- as in sickle cell treatment -- controversy still plagues the research community.

Reminiscent of Tuskegee

In September, the executive editor of the New England Journal of Medicine charged that a study of pregnant HIV-infected women in Third World countries was reminiscent of the Tuskegee experiment. The HIV study is on the drug AZT, which is the standard treatment in the U.S. and has been shown to be effective in preventing the transmission of AIDS. But because it is so expensive, the study is trying to determine if half of the standard dose has any positive effect on the disease. To do that, female participants in the study are sorted into three groups: one which receives a full standard dose of AZT; one which receives half the standard dose; and one which receives a placebo (a medicinally inactive preparation) of the drug.

Dr. Marcia Angell, the outraged executive editor, feels that the use of placebos is putting both the mother and the unborn infant at unacceptable risk. She worries that like the Tuskegee experiment, people are being denied treatment which could save or extend their lives.

Apparently Angell's concerns have struck a chord in the world of medical research. In late October, researchers in an AIDS study in Ethiopia being conducted by Johns Hopkins University in Baltimore decided not to use placebos with pregnant women. But some researchers have defended the use of the fake pills as necessary to ensure the validity of the research and thus, ultimately, help more people than it may harm.

This dilemma -- Does the potential good to society outweigh the potential harm to the individual? -- has frequently plagued medical research and fueled skepticism, particularly in the minority community, about its motives.

In the current study of diabetes, however, the skepticism seems to have dissipated. And according to David Nathan, M.D., study chair of the DPP and director of the Diabetes Center at Massachusetts General Hospital in Boston, researchers are within sight of their goal of 50 percent minority participation.

"It's wonderful that we are getting that kind of participation," Nathan says about the fact that as of late September, approximately 45 percent of participants nationally are minorities. "And it seems to be getting better. I'm sure we'll meet or exceed our goal of 50 percent participation."

"This is particularly important because African Americans, Asian Americans, Hispanic Americans, American Indians, and Pacific Island Americans are disproportionately affected by diabetes," Ratner said in June at the American Diabetes Association's Annual Scientific Sessions in Boston. "We hope this high level of participation will aid us in our goal to serve those communities and to ensure that the study's results are applicable to those populations."

Apparently, there are two reasons for the reduced skepticism. One is the topic of research.

"When the word diabetes came up, there seemed to be less resistance to the project," says Nathan. "Diabetes is so pernicious and devastates minority communities in so many profound ways. People had relatives, friends affected by the disease. Once they found out what we were studying and saw that it could be useful, resistance from the community faded away."

The other reason involves a difference in methodology and a difference in research personnel.

"We have come to understand how important it is to be sensitive to the different communities and the diversity within those communities," says Nathan. "We did not want this to appear like it was the government going into the community and using them as guinea pigs. We worked very hard to establish a rapport with community groups and earn their trust and respect."

And Ratner adds: "There are several major differences between [medical research] now and in the past. First, unlike the 1930s, 1940s, and 1950s, when research was done on captive populations -- like inmates and communities selected for study -- now, such studies are open to volunteers and they come to us rather than us going to them."

That means, according to Ratner, the researchers have to gain the confidence of the participants. As a result, a "new generation of investigators [have emerged] who are sensitive to the fears of participants."

"Trust and honesty are important to the patient," he says, "and their faith in [our] ability to provide them with appropriate medical care should problems develop."

Receiving the Benefits

Ratner's comments of trust and honesty echo the sentiments of one of the participants in the Diabetes Prevention Program at the Medlantic Center.

"As a lawyer, I read the consent decree very carefully," says Jane Doe a Black woman from Chevy Chase, Maryland, who wishes to remain anonymous because of worries about her health insurance provider. "They explained each step of the process. I had no qualms about the safeguards involved. It's an open study and if you should get ill, you can leave the study or allow them to treat the illness. You can leave the study at any time. The pros definitely outweighed the cons."

Jane Doe also feels that studies such as this are extremely beneficial.

"There are a lot of medical problems that we have as women that could be related to diabetes and glucose intolerance," she says. "I thought I was going through premature menopause and found out that it was something else entirely."

Would she participate, in another medical study?

"It depends on what it is and why they are doing the study," she says. "Would I do drug testing? Probably not. But something like this, yes. It can only benefit me because it will improve the quality of my life."

And that is exactly the point Ratner makes about the importance of minorities participating in medical research.

"When [participants] ask at the end of a study, `What do you have for me now?,' that is very reassuring to me because it means we are meeting out commitment to patient care," says Ratner.

"Truth, honesty, and providing appropriate medical care is what [minority participants] expect from us," he continues. "As more and more participate, ethnic minorities will get the benefits from medical research that they have been excluded from in the past."