There appears to be yet another reason to scrutinize clinical trials - exclusion of lesbians and gay men from clinical trials in the US, particularly those with sexual function as an end point, according to an analysis that was published in theletters section of The New England Journal of Medicine.
A search using the terms "couples," "erectile dysfunction," and "hypoactive" (related to hypoactive sexual disorder), yielded 243 studies, of which 37, or 15 percent, had explicit exclusionary language. The results indicated that industry-sponsored trials, multi-region trials (according to census definitions), and Phase III trials were the most likely to exclude lesbians and gay men, according to researchers at Fox Chase Cancer Center in Philadelphia.
They also examined eligibility criteria in 1,019 studies using 'asthma' as a search term and found these didn't have high rates of exclusionary language, and no asthma trials excluded lesbians and gays. But they did notice an ADHD clinical trial that required participants be "in a reciprocal relationship with a person of the opposite sex."
The researchers wrote that "exclusion of lesbians and gays from clinical trials is not uncommon...and it's likely that most gay and lesbian patients are unaware their sexual orientation is being used as a screening factor for participation in clinical trials." At the same time, there was no indication people running the trials intended to discriminate against gays or lesbians, according to Brian Egleston, one of the researchers who wrote the letter.
It may simply be tnhat boilerplate language is repeatedly used. "This has really become a copy and paste issue," he tells The Philadelpha Inquirer.
Among the 37 trials restricted to heterosexuals, one studied the use of Levitra, to improve erectile dysfunction after nerve-sparing prostate surgery. A spokeswoman for Bayer tells the paper it was limited to heterosexual males because scientists used a standard measure of erectile success that relates specifically to opposite-sex couples. The questionnaire asks, among other things, whether the male was able to insert his penis into the female reproductive organ.
The ADHD study, which was sponsored by Lilly, looked at whether ADHD was alleviated by Strattera, and examined impacts on "family functioning." "The scales used to examine family functioning were designed and validated for use with heterosexual couples," a Lilly spokeswoman tells the paper. "ADHD can occur in anyone, regardless of gender or sexual orientation, and all families can be affected by it. Lilly supports treating ADHD in any setting and with any type of family."
The Inquirer notes that the National Institutes of Health has guidelines to ensure women and minorities are included in trials, except for a medical reason, but none exist for people of various sexual orientations. However, the paper adds the NIH asked the Institute of Medicine to study and identify priorities in research with lesbian, gay, bisexual, and transgendered populations.