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The Race Factor in Medicine
Amid controversy, approval of heart drug for Blacks
underscoresneed to get more minorities into clinical trials, experts say
By Francesca Kritz
Special to MSNBC.com
June 28, 2005
Just as scientists have found in recent years that certain medications
may affect men and women differently, they’re now discovering that the
effects also can vary among racial groups — many of whom have long been
excluded from drug studies.
Last week, the Food and Drug Administration OK’d a controversial heart
drug exclusively for blacks. The approval of the drug, BiDil, was based
on data of more than 1,000 patients with congestive heart failure.
Large drug trials aren’t unusual when it comes to heart disease, which
affects millions of Americans, but this one was because all of the
participants were Black.
That’s a big change from business as usual in the pharmaceutical
industry. Most drugs have only been tested in whites, and generally
white men, at that. However, the FDA and the National Institutes of
Health have recently stepped up their efforts to get drug manufacturers
to include more minority and women participants in clinical trials.
This is important because trials involving white men only can’t take
into account potential variations such as different metabolic rates and
levels of enzymes in women and minorities that may impact how effective
a drug will be and whether it might cause side effects. For example,
East Asians, according to the National Pharmaceutical Council, a
research group sponsored by drug companies, metabolize codeine
differently than whites and need to be given higher doses for effective
pain relief. BiDil, according to Nitromed, the drug’s maker, seems to
boost nitric oxide in Blacks, many of whom may suffer worse heart
failure than some whites, perhaps because of insufficient nitric oxide,
a gas found in certain cells that line blood vessels.
Minority health care leaders say BiDil’s impressive trial results —
participants had a 43 percent increase in survival compared to patients
who took standard therapy but not BiDil — point to the need for more
clinical trials that include significant numbers of minorities, or
minorities only.
"The results of the [BiDil] trial provide the first step towards what
must be a long-term commitment on the part of government, industry and
organized medicine to … identify the … appropriate therapies for all
conditions that compromise the health and well-being of America’s
multi-ethnic population," says Gary Puckrein, executive director of the
National Minority Health Month Foundation, based in Washington, D.C., a
group whose mission is to improve the health status of racial and
ethnic minorities.
Disparities in care plague minorities
Improving that status is front and center these days, stemming in large
part from a Congressionally mandated study that underscored the poor
health care minorities get in America. The study, produced by the
venerable Institute of Medicine in Washington, D.C., and published at
the end of 2002, found that even after accounting for differences in
health insurance and income, racial and ethnic minorities in the United
States receive lower quality health care than non-minorities.
In part because of the IOM report, several major organizations,
including the Robert Wood Johnson Foundation and the Kaiser Family
Foundation, have begun minority health initiatives, and earlier this
year the American Medical Association, National Medical Association
(representing African-Americans) and National Hispanic Medical
Association joined forces to form the Commission to End Health Care
Disparities.
"A one-size-fits-all approach to medicine does not recognize the
special needs of our diverse patient population," says Dr. Elena Rios,
president of the National Hispanic Medical Association. The commission
is focusing much of its efforts on physician training, including
increasing the number of minority physicians, and creating learning
tools for doctors such as video vignettes showing positive and negative
interactions between physicians and minority patients.
The various commissions and studies point to a host of factors that can
result in health care inequality, including a mistrust by minority
patients of doctors from a different ethnic group, cultural and
language barriers, and bias and stereotyping among physicians.
But the BiDil trial also underscores the need for well-designed
clinical trials that tell doctors whether a drug will be effective in a
particular population, and if so, at what dose. For example,
AstraZeneca, maker of Crestor, a cholesterol-lowering drug, has
conducted studies among both Blacks and Asians, and will also be doing
clinical trials of the drug in Native Americans. Just this past spring,
the FDA issued an advisory noting that in clinical trials Asians had
double the level of the drug in their bloodstream when compared with
whites, increasing their risk of muscle damage from the drug. To avoid
the increased levels, the FDA changed the drug’s package labeling to
recommend that doctors consider starting their Asian patients taking
Crestor at the lowest (5 milligram) dose.
Yet while minority participation in clinical trials offers the
potential to better target drugs and doses, researchers worry that such
trials could also backfire and make some doctors treat all ethnic
populations the same way, without taking into account a person’s
specific body make-up as well as other illnesses and other drugs the
patient takes that can also affect how well a drug works.
Concerns about a ‘race drug’
At a press conference earlier this month before an FDA advisory
committee voted whether to recommend BiDil’s approval, a group of
minority health care leaders expressed concern that the drug has been
characterized as a "race-specific" drug and they pointed to the
possibility that the drug may be beneficial in a broader range of heart
failure patients.
"In the [clinical trial] social race is being used as a proxy — a
profoundly imperfect one — to identify patients who might find benefit
in this particular drug," said Ngozi T. Robinson, director of health
disparities initiatives at Genetic Alliance, Inc., in Washington, D.C.
"We strongly encourage [post-FDA approval] monitoring or testing to
determine at the cellular level patients that would benefit from BiDil."
"The assertion that this is a race drug is misguided," says Dr. Randall
W. Maxey, former president of the National Medical Association. "The
[BiDil] researchers do not assert that all African-American congestive
heart failure patients will benefit from BiDil, or that [the trial]
demonstrates that it is not effective in other population groups that
can be categorized by social race."
Other doctors agree. "I am certain that BiDil will not be effective in
all African-Americans and will be effective in many white Americans,’’
says Waine Kong, chief executive officer of the Association of Black
Cardiologists.
Experts point out that while BiDil is likely to be an important
breakthrough, it could be just as detrimental to treat all black
patients with the same drug indiscriminately as simply giving them
whatever drug works in other populations.
‘An interim step’
Which is why many experts, such as Mark Schreiner, who directs the
clinical trial program at the Childrens’ Hospital of Philadelphia,
views clinical trials that focus on minorities as an "interim step."
Schreiner says clinical trial participation from minorities is very
important until scientists are able to do more focused drug targeting —
pharmacogenomics, a discipline only in its infancy, which can tailor
therapy for each specific patient based on individual genetic
information and other characteristics.
But getting minority patients to participate in clinical trials has
often been difficult. Of about 200,000 cancer patients eligible for
clinical trials each year, only about 25 percent of all patients
participate, according to the Coalition of Cancer Cooperative groups,
whose member groups conduct many clinical trials across the country. A
very small percentage are minority patients, for a variety of reasons,
including the fact that researchers tend to be white and there is often
a high level of mistrust and fear by minorities, says Deborah Watkins
Bruner, director of the Prostate Cancer Risk Assessment Program at the
Fox Chase Cancer Center in Philadelphia.
It’s not enough to hang out a sign asking minorities to sign up, say
health care leaders. Researchers need to learn about each group and
approach individuals in a way that makes them understand that the trial
will take their health and dignity into account.
For example, prostate cancer disproportionately impacts the Black
community, according to Bruner, so in order to get larger numbers of
blacks into a trial to assess risk, her group used "social marketing."
They put together African-American focus groups to help design the
trial and enlisted the aid of community radio show hosts to broadcast
public service messages to recruit participants — to great success.
Bruner says that while blacks make up less than 5 percent of patients
in most clinical trials, they accounted for 59 percent of patients in
the risk-assessment trial.
"Acknowledging the dissimilarities between the strategies that motivate
African-Americans and whites in accessing health services can assist in
designing effective recruitment strategies for each population,"’
Bruner says.
Enlisting physicians of the same ethnic group often takes away the
mistrust patients can feel, which is why the National Institutes of
Health recently announced a program that helps local hospitals with
large ethnic populations create the internal infrastructure necessary
to conduct a clinical trial locally, says Jonathan Doroshow, director
of the division of cancer treatment and diagnosis at the National
Cancer Institute.
And earlier this month, Baylor College of Medicine, the Intercultural
Cancer Council and Genentech announced an initiative to determine
barriers to recruitment and retention of minority patients in clinical
trials on cancer and asthma.
Remembering Tuskegee
Recruitment strategies for each population are important, says Bruner,
because of cultural differences that impact actions. For example, some
Asians may be reluctant to join trials because of their trust of
healers and complementary medicine over modern medicine and largely
white physicians. And some Hispanics may be wary because of concern
over their immigration status. For blacks, says Jennifer Gray, a
researcher in minority participation in clinical trials at the
University of Texas at Arlington, Tuskegee looms large.
In the Tuskegee study, hundreds of poor black men over four decades
believed they were receiving treatment for syphilis. No treatment was
given. The intention of the study, approved by the U.S. government, was
to review the men’s autopsies in order to learn about the effects of
syphilis. Since 1999, as part of a response to an apology issued by
President Clinton, Tuskegee has had a bioethics center created to study
ethics in health care issues for blacks and other underserved
populations.
Slowly, say experts, things are changing. Ask Deborah Lee, 48, who
participated in the BiDil trial last year. Lee was in the placebo part
of the trial, but when the drug showed significant benefits in those
getting the actual medicine, the trial was stopped and all participants
were offered BiDil. Lee says the difference is astounding. Before, she
could barely walk because her breathing was impaired from the heart
failure, and now she’s back at work at the Art Museum of Indianapolis.
Beyond the drug, Lee says she liked the feeling of knowing she had
personal attention during the trial from her health care providers, who
happened to all be white.
Reaching the goal of equal care will largely fall to the medical community, say experts.
"Until now, we haven’t been doing a good enough job," says David
Wetter, who was recently named chairman of the health disparities
research department at the University of Texas M.D. Anderson Cancer
Center.
Francesca Kritz is a freelance writer based in Washington, D.C.
URL: http://www.msnbc.msn.com/id/8283953/
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© 2005 MSNBC.com
