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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."


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.

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