A Medical Imbalance : After a long history of testing treatments primarily on white men, scientists are trying to include women and minorities. Attracting them could mean saving more lives--but it’s a challenge
It was envisioned as one of the first ethnically balanced, large-scale studies of its kind: a trial of 16,000 women to test tamoxifen’s ability to prevent breast cancer in women at high risk.
But when researchers began recruiting subjectts for the nationwide drug study in 1992, they were able to attract few minorities. Just 2% of the initial study population were African Americans, Asian Americans, Latinas or Pacific Islanders.
A later recruiting drive, this time targeting ethnic groups, raised the percentage to 4. But researchers, who had hoped for up to 20%, remain troubled. If a significant number of minority women aren’t enrolled soon, researchers will be unable to answer a key question when the study ends: Does the drug work any differently in women of color?
Experts now estimate that about 60% of the study’s final 5,000 to 6,000 women will have to be minorities--a daunting number by any research standards--in order to answer that question.
Researchers in the tamoxifen study are hardly alone in their dilemma. After a long history of testing medical treatments primarily on white men, scientists performing federally funded research are now generally required to enroll a certain percentage of women in the studies and, in many cases, a certain percentage of racial minorities.
But opening this door to better and certainly more equitable science has not resulted in a flood of candidates. Many studies designed to include minority women are sorely lacking in participants.
“Almost all the studies going on right now are underrepresented in terms of women of color,” says Dr. Antronette K. Yancey, an assistant professor of public health at UCLA.
The reasons for the poor participation are complex and suggest that improvements won’t be simple to achieve. According to Dr. Machelle Allen, an obstetrician at the New York University Medical Center who has studied the issue, the reasons include:
* a history of unethical and abusive studies involving minority groups;
* discrimination in medical care;
* practical barriers, such as a lack of transportation to clinical trials or time to participate in them.
According to an article by Allen in a recent issue of the Journal of the American Medical Women’s Assn., the efforts to establish race-based quotas for participation in clinical research will be unsuccessful unless these problems are addressed.
“These are complicated issues,” Yancey acknowledges. “(Participation in studies) takes a certain attitude and mind-set. But before that, it takes a lot of information.”
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From a historical perspective, it should be no surprise that minorities--especially women--distrust clinical research, which oftentimes divides patients into two groups--one group receives the experimental therapy and the other receives a placebo or no therapy.
Some of the most notorious examples of unethical medical research involved minority groups, says Leslie Laurence, co-author of the book “Outrageous Practices: The Alarming Truths About How Medicine Treats Women” (Fawcett Columbine, 1994).
“There is the fear on the part of some minority women that they are going to be used as guinea pigs,” says Laurence, whose book documents how women in general have been ignored in medical research. “It’s the legend of Tuskegee.”
The infamous 1932 Tuskegee study looked at untreated syphilis in black men. Treatment with penicillin was withheld from the men even though their death rate was twice as high as normal. The study was eventually exposed and halted.
And there are other examples.
Between 1845 and 1849, Dr. J. Marion Sims--widely known as the “father of American gynecology”--performed 42 surgeries on Alabama slave women without their consent or the comfort of anesthesia in search of a cure for fistulas (a tear from the bladder to the vagina), Laurence recounts in her book.
And, in the 1950s, a group of mostly poor Mexican American women were enrolled in a trial to study the side effects of oral contraceptives. According to Allen, all the women thought they would receive oral contraceptives. None of the women were informed that they would actually be taking a placebo some of the time. Ten became pregnant while on the placebo.
While oversight committees--called institutional review boards--are now used to protect patients and ensure that ethical guidelines are met in clinical trials, conducted under scientifically rigorous conditions, the mistrust lingers, Allen says.
“The history of abuse in the name of research has created fear and skepticism,” she says in her journal report. “It will take more than the assurance of an institutional review board to undo the generations of harm done by research abuse.”
Besides trust, many people simply do not know that they are eligible to participate in medical studies. This is especially true of disadvantaged women, particularly minorities who may not even see a doctor or go to a clinic on a regular basis, Laurence says.
“The care these women get is often fragmented. They already feel frustration with the medical system. And often, to get into a trial, you have to be referred by your personal doctor,” she says.
Practical issues also come into play.
“If a woman is also low income, she may not have the child care or transportation to get to the trial site,” Laurence says. “Altruism isn’t enough of a reason to take a bus for two hours.”
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Experts agree that diversifying studies will result in more precise medical practices that are based on gender and ethnic makeup. For instance, in certain ethnic groups, some drugs are metabolized differently, and some diseases are more prevalent and even appear deadlier.
“We want to be sure that a new treatment . . . would apply equally across various ethnic groups,” says Dr. John S. Kovach, executive vice president for medical and scientific affairs at the City of Hope National Medical Center in Duarte.
Biological differences among ethnic groups, while rare, are of extreme importance in medicine.
For example, a recent study in the Journal of the American Medical Assn. found that black women with breast cancer are more than twice as likely to die from it as white women, in part because the malignancies are often more aggressive and fast-growing.
Thus, the results of the 16,000-women, $68-million Breast Cancer Prevention Trial to test tamoxifen for disease prevention will be, perhaps, of greater significance to African American women.
“We certainly are anxious to recruit women of color,” says Dr. Leslie Ford, who is directing the study for the National Cancer Institute. “In black women, breast cancer rates are higher at a younger age. And when they get it they seem to die more often. That is why we need to know what happens with the (black) women who take tamoxifen.”
Researchers exploring AIDS treatments are also concerned about minority involvement in trials, Allen says. For example, the early studies on zidovudine--the first approved treatment for HIV--did not address possible racial differences.
Blacks and Latinos, especially women, are still slightly underrepresented in some studies at the UCLA CARE Center, says the director, Dr. Ronald Mitsuyasu. The center--which stands for Clinical AIDS Research and Education--is one of the leading AIDS research institutes in the nation, with more than 11,000 people involved in studies.
“We recognized quite early that we were deficient in terms of our minority enrollment. But it hasn’t been easy,” Mitsuyasu says.
The CARE Center has offered taxi and bus vouchers, free meals and child care to attract study volunteers. Researchers are even giving more attention to the demands of their studies, looking for ways to reduce tests or clinic visits that are not essential.
“We need to think long and hard about whether we absolutely need a certain test, such as a weekly blood test, in a study,” Mitsuyasu says. “Just from a fairness standpoint, we have to make it easier for people for whom it’s not easy to participate.”
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Yancey has demonstrated that if you make it easy and understandable, they will come. To recruit volunteers for her study on how diet and exercise can influence the health of African American women, she hit the public lecture circuit, ran radio spots and newspaper blurbs, and offered participants a free three-month fitness-club membership and a cookbook featuring the healthiest recipes of black American chefs.
Yancey also appealed to the women’s sense of fairness with the message that cancer and heart disease kill African Americans more than any other group. “When programs are developed to fight cancer and heart disease, our voices must be heard. After all, our tax dollars are paying for it,” she said in the study literature and radio spots.
When told what the study entailed and how they would benefit, the women had no hesitation.
“I have connective tissue disease, and I had gained 20 pounds in the last six months. So I felt that anything that can benefit my health would be great,” says Peyton Chappell, 44, who joined the study.
Debra Moore, 43, says she was intrigued with a medical study that was exclusively for black women.
“I thought, ‘Well, that’s a new concept.’ You hear about studies all the time with Caucasian males, and even white women. So when they get around to studying black women, I figured, ‘it’s my turn,’ ” she says.
Researchers hope that attitude catches on as they begin recruitment this winter on the largest-ever study on women--the Women’s Health Initiative--which will involve 163,000 post-menopausal women at 40 research centers nationwide. The 15-year, $628-million trial will study chronic diseases that affect women.
And, in the most sweeping attempt ever to include minorities in medical research, various centers will set goals for minority recruitment ranging from 10% to 60% of their total participants.
“The Women’s Health Initiative is making an enormous attempt to recruit minority women,” says Dr. Howard Judd, the principal investigator at UCLA for the trial. “And there is serious concern about the ability to do this--it’s one thing to recruit African American women, but there are now, in California, so many minority groups.”
But because the Women’s Health Initiative was largely conceived as a result of the longstanding exclusion of women and minorities from medical research, to settle for less would be wrong, Judd says.
“There was so little work being done in minorities and in women that we really need to recoup that and make an effort to bring them in.”
How to Be a Test Subject * The Women’s Health Initiative. Open to post-menopausal women of all ethnicities, ages 50 to 79, who plan to live within the area for at least three years. (800) 54-WOMEN.
* The Breast Cancer Prevention Trial. Open to women 35 to 59, of all ethnicities, who are at high risk for developing breast cancer. (800) 4-CANCER.
* The Eating and Exercising for a Cancer-free Life study. Open to African American women. (310) 794-8590.
