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Gays Needlessly Excluded From Many Clinical Trials

By L.K. Regan

A research letter in the March 18th New England Journal of Medicine says that gay men and lesbians are often excluded from clinical trials for medical treatments, particularly, the authors write, "in studies with sexual function as an end point."

Trials for new drugs or treatments frequently come with exclusions, such as age, gender, or health status and disease history. But, says Brian L. Egleston, the study's lead author and an assistant professor at the Fox Chase Cancer Center, "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." Unfortunately, he adds, "there's not this same level of oversight when it comes to gay and lesbian patients."

Clearly not. Egleston, Roland L Dunbrack, Jr and Michael J. Hall, all of the Fox Chase Cancer Center, were prompted by their recent encounters with "proposed studies that explicity excluded persons in same-sex relationships" to perform a short study of their own. They searched a government website ( that houses information on more than 80,000 clinical trials, including those sponsored by the government and the NIH, as well as by private funding. The researchers checked the database for the terms "couples," "erectile dysfunction," and "hypoactive" (as in, hypoactive sexual disorder, or an absence of sexual desire) and checked the resulting studies' protocols for language excluding gay people.

"We identified 243 studies," the authors write, "of which 37 (15%) had explicit exclusionary language." Furthermore, they say, trials sponsored by industry, covering multiple regions of the U.S., and in their third phase were the most likely to be exclusionary—indicating that the broader the study, the less gay its subjects. "The trials that exclude gay and lesbian patients tend to be larger efficacy clinical trials. Further, by requiring patients to be in heterosexual relationships, many studies are also excluding unmarried or unpartnered patients regardless of sexual orientation," says co-author Roland Dunbrack, Jr., Ph.D. And it seems the problem may appear in other kinds of studies as well—in fact, the researchers found gays and lesbians excluded from one study on attention deficit-hyperactivity disorder.

"It is likely that most gay and lesbian patients are unaware that their sexual orientation is being used as a screening factor for participation in clinical trials," the authors write. Therefore, "Researchers should be held to careful scientific reasoning when they develop exclusion criteria that are based on sexual orientation."