Clinical Trials Debate Continues: Asian American women want their fair share of clinical trials--but what is fair?

IMPROVEMENT ON THE WAY: NAWHO President Mary Chung says that better education within the Asian American community will incease participation of Asian American women in clinical trials. Asian Americans comprise approximately 4 percent of the U.S. population, and they now account for 4 percent of the women enrolled in U.S. National Institutes of Health-sponsored clinical trials. This satisfies the spirit of the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, promulgated in 1994 in response to Congress's NIH Revitalization Act of 1993. The will of Congress was to ensure that women and minorities were included proportionally in NIH-sponsored clinical trials (M. Watanabe, The Scientist, 9[5]:14, March 6, 1995). But health activists in the Asian American communities are not satisfied with the 4 percent representation in clinical trials. And, as pointed out by oncologist Otis Brawley, director of the Office of Special Populations of the National Cancer Institute (NCI), proportional representation does not necessarily equate with fair representation in clinical trials. One activist group, the National Asian Women's Health Organization (NAWHO), decided to face the issue and discuss what can be done to make representation of Asian Americans, specifically Asian American women, fairer. The group held their first health summit at the NIH on Oct. 9, at Brawley's invitation. Formed in San Francisco in 1993 by a group of Asian American women, NAWHO (www.nawho.org) now represents 3,000 members and has a $1.5 million budget. As proof of its coming of age, the organization is moving its headquarters to Washington, D.C. NAWHO's president, Mary Chung, is a health activist who has been working her way through the power structure at the NIH to get her group's message heard. "Women are generally underrepresented in clinical studies, and it's no exception for Asian American women," she says. This, she points out, is especially important because the U.S. population of Asian descent is growing very rapidly. Chung contends that better education within Asian American communities will increase the participation of Asian American women. Otis Brawley But if Asian American women are proportionally represented in NIH-sponsored trials, what is the problem? "The NIH/NCI policy to include minorities and women in clinical research was certainly well intentioned but, in actuality, as it is currently designed, it does little to benefit actual sub-population groups such as Asian Americans and Pacific Islanders," explains Susan M. Shinagawa, a former administrator at the University of California, San Diego Cancer Center, and an active member of the Intercultural Cancer Council (ICC), a national health-policy advocacy group in Houston. Brawley aptly illustrated the problem by explaining that in 1997, 2.1 percent of the women accrued into all NCI clinical trials were of Asian descent. But American women of Vietnamese descent have the highest rate of cervical cancer of all women--approximately twice the rate of Hispanic and African American women. This translates into 120 new cases of cervical cancer a year in this group, and most of these are early-stage cancers that may not be amenable to inclusion in clinical trials. Thus, Brawley states that even if all eligible Vietnamese American women joined the NCI-sponsored clinical trials, the study results may not have the statistical power to say anything about cervical cancer within the Vietnamese American community. Does this mean that Vietnamese American women should not join the clinical trials? Not at all, says Brawley. "We should do our research so that we are serving all people, that our research findings are relevant to all people, be they black, white, Hispanic, whatever." Edison Liu, NCI's director of the Division of Clinical Sciences, explains that this is an issue of social justice. "All citizens have a right to participate in government-sponsored activities," he says. "But achieving social justice may not" result in the best scientific results unless the study has sufficient statistical power. As Liu points out, in all but the largest cohort studies, in which 3 percent of the accrued number of participants may number in the thousands, there may not be sufficient statistical power to come to a conclusion concerning a racial subgroup. Instead, oversampling an ethnic subgroup so that they are overrepresented in a clinical trial may sometimes be the only way to discern population differences. But there are reasons other than social justice to accrue underrepresented minorities into these smaller clinical trials, says Liu. These include the ability of clinical trials to allow physician participation in a new treatment regimen, educating the physicians about the regimen, and leading to rapid dissemination of techniques among the members of the medical community. This will ensure that the cancer care provided underrepresented minorities would conform to contemporary principles. But activists within the Asian American community believe there are significant problems to be overcome before Asian Americans can be successfully recruited into many clinical trials. One problem is access to the trials. "The Asian American women who are fluent in English and more acculturated may be able to get into clinical trials easier than the non-English speaking immigrant women," says Evaon Wong-Kim, an oncology social worker at San Francisco General Hospital and an ICC member. Wong-Kim points out that the problem is in accruing low-income participants into the studies. Sometimes, studies are culturally inappropriate. Shinagawa, who was on a review committee for a breast cancer research program in California, gives an example: "One study was designed to compare the quality of life and coping skills of breast cancer patients randomized to a conventional, facilitated support group versus a support group [that] encouraged women to outwardly express anger about their disease." Shinagawa explained to the committee that "Most Asian-Pacific Islander women don't participate in support groups in the first place. Secondly, if you subjected my mother, a Nisei [second-generation Japanese] woman who copes extremely well in adverse situations, to a situation in which she was encouraged to verbally and physically express her anger, she would go bonkers. Culturally, as a Nisei woman, such anger about health would be foreign to her." Some at the NAWHO meeting suggested that perhaps the best way to study Asian Americans and get clearer results is to study Asian American women as a group, comparing them to another racial or ethnic group. "In fact," says Liu, "some of the best studies are done in pure populations," referring to the NCI's study on the presence of the BRCA-1 breast cancer gene in Ashkenazi Jewish women in the Washington, D.C., area (J.P. Struewing et al., New England Journal of Medicine, 336:1401-8, 1997). At the NAWHO meeting, Amy Seetoo, director of the Healthy Chinese Americans Project at the University of Michigan School of Nursing, Ann Arbor, proposed, "Vietnamese women have the highest rate of cervical cancer, and Jewish women have the lowest rate. Should these two be compared?" "I think what is more important is to make sure these studies are conducted by Asian American researchers who know enough about our community," says Wong-Kim. "We must begin to include more women and minorities as PI's [principal investigators on a research project] and also on IRBs [institutional review boards of medical centers that control clinical trials]," said Darlene Yee at the NAWHO meeting. Yee is director of gerontology at San Francisco State University. Where to go from here? "It was clear to me that we need to do more education about clinical trials as an available, high-quality health care option for Asian American women. We're looking forward to working with NIH and also the scientific community to establish partnerships," says Chung. She adds that a meaningful cooperation between the scientific community and consumer groups, such as NAWHO, is the way to reach the goals. Jacques Rossouw "We figured it was time that we got the real data so that there can be a sound basis for public health recommendations," says Jacques Rossouw, WHI project officer. Organizers started the five-year recruitment process in September 1993; they're still looking for volunteers--especially minority women--for the observational study. The clinical part of the study will inspect both the supposed beneficiary effects of estrogen alone and in combination with progesterone (such as in preventing heart disease), and the reported potential negative effects (such as increased incidence of breast cancer and gall bladder disease). "We'll get the overall risk-and-benefit picture," explains Rossouw. In the dietary portion of the clinical program, which includes 48,000 women, participants will be required to stick to a diet extremely low in fat--lower, even, than recommended by the American Heart Association. Women enrolled in one of these two studies may also participate in the final part of the clinical trials. In that portion, participants will be given either calcium and vitamin D or a placebo to test for the effects on fracture prevention. The observational study, 93,000 strong, will investigate how well lifestyle factors, including smoking, body weight, and diet, predict health and disease. The community prevention study will explore how women should go about choosing the healthiest behaviors. --E.R. FOR MORE INFORMATION WHI Web site: www.nhlbi.gov/nhlbi/whi1/ Myrna Watanabe is a freelance writer based in Patterson, N.Y.

Clinical Trials Debate Continues: Asian American women want their fair share of clinical trials--but what is fair?

Interested in reading more?

Become a Member of