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

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

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.

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.”

COPYRIGHT 1997 Cox, Matthews & Associates



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