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updated 6/28/2005 2:14:57 AM ET 2005-06-28T06:14:57

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.

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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.

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