Are Gay People Excluded From Clinical Trials?

March 18, 2010— -- Concerns about gay discrimination expanded from matrimony or the military to a new corner of society this week: clinical trials for medical treatment.

Experts at the Fox Chase Cancer Center in Philadelphia worry that doctors may needlessly exclude gay men and lesbians from clinical trials that investigate a range of topics from cancer to diabetes and depression.

A study of 243 clinical trials related to couples and sexual function after various medical treatments showed that 37 trials explicitly excluded people in same-sex relationships, according to a letter published in the New England Journal of Medicine Wednesday.

"The National Institutes of Health guidelines really require scientists to have sound scientific reasoning for why they need to restrict the study to one ethnic group or sex," said Brian L. Egleston, lead author on the paper and an assistant research professor at Fox Chase Cancer Center in Philadelphia. "But there's not this same level of oversight when it comes to gay and lesbian patients."

How Gay and Lesbian Patients Change Research

Doctors wanting to test a new drug or treatment often use age, behavior, disease or sex to narrow down which people can participate in clinical trials. It's a crucial step to make sure the drug is tested only on those who could benefit and that outside diseases or behaviors don't complicate the experiment.

"It's not unusual in studies to decide who your target population is and exclude people who are not in this target population," said Susan Cochran, a professor of epidemiology at the University of California, Los Angeles School of Public Health. Cochran was not involved with the study.

"The bigger problem is if everyone just decides they're going to exclude sexual minorities," she said. "Then their health issues are never dealt with."

Research Lacking on Health of Gay People

Egleston agreed and pointed out that historically, many medical studies were done only on white men -- leaving doctors only to guess that the same treatment would work as well in women or in all ethnic and racial groups. Egleston worried the same problem will now hit the gay community.

Moreover, Egleston said, gay patients at a cancer center, for example, might miss out on the opportunity to try promising experimental treatments.

"Lesbian and gay patients probably never realized they were excluded in these trials," said Egleston. "There might be opportunities for experimental treatment."

Not all the studies Egleston reviewed asked about sexual orientation. In 1,019 studies that he and colleagues identified by using the search term asthma, "exploratory searches indicated that such studies did not have high rates of exclusionary language," he wrote in the article on the study.

Does a Fear of Unknown Factors Keep Gay Health in the Dark?

James Beaudreau, education and policy director of the Gay and Lesbian Medical Association, said excluding gay people from health research is nothing new.

"For instance, most national health surveys do not include questions about sexual orientation and gender identity," said Beaudreau, who added small studies have shown "that health disparities affecting gay and transgender people are significant and well-documented."

"The lack of inclusion of these questions frustrates efforts to get a true sense of the magnitude of these health disparities," he said.

This also presents a troubling catch for researchers developing clinical trials. On the one hand, researchers don't want to have unknown health issues in a research trial that could interfere with an experiment. On the other hand, the only way to learn more about health disparities is to do research.

Cochran said some research has suggested depression, anxiety and suicide rates are different in the gay population than in the heterosexual population.

"But it's very difficult to get a handle on this unless these studies include sexual minorities," she said.