Monday, March 22, 2010

Gay patients sometimes excluded from clinical health trials

A portion of the population could have health issues that are being ignored.

There are, unfortunately, many corners of our society that still exclude people who are gay. In most states, gay couples cannot marry; gay people cannot serve openly in the military, and some states even go as far as excluding gays from being able to adopt children. But scientists and doctors are now fearing that another type of exclusion is taking place - one that could have effects on those people’s health and wellness: clinical trials that examine diseases, drugs and medical treatments.

A letter published recently in the New England Journal of Medicine showed that 37 of 243 clinical trials studied that dealt with couples and sexual function barred people who were in same-sex relationships. Researchers at the Fox Chase Cancer Center in Pennsylvania who conducted the study worry that gay patients are routinely excluded from other studies as well, such as ones that study depression [] or cancer.

Doctors hoping to create a clinical trial to study a drug often develop a target demographic of people who are a certain age, have a certain disease, or participate in a certain kind of behavior associated with the drug in order to narrow down those who’d be most likely to use, and benefit from, the drug. It’s a vital element to creating a clinical trial. But if doctors, for whatever reason, universally exclude gay participants, then a whole segment of the population will inevitably have health issues that aren’t addressed or uncovered in such trials.

Brian Egleston, Michael J. Hall, and Roland Dunbrack wrote that not all clinical trials use exclusionary language, and that often, gay and lesbian patients might not even be aware that they’re missing out on certain trials:

“To ensure that we did not miss a general pattern of exclusionary language, we also examined eligibility criteria in 1019 studies that we identified by using the search term ‘asthma.’ Exploratory searches indicated that such studies did not have high rates of exclusionary language, and indeed, no asthma trials were found to exclude lesbians and gay men. However, we incidentally found a clinical trial of attention deficit–hyperactivity disorder that required that participants be ‘in a reciprocal relationship with a person of the opposite sex.’

Our results indicate that exclusion of lesbians and gay men from clinical trials in the United States is not uncommon, particularly in studies with sexual function as an end point. 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. Researchers should be held to careful scientific reasoning when they develop exclusion criteria that are based on sexual orientation.”

Photo credit: Tom Varco

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1 comment:

  1. Clinical Trials also represent the last and only avenue for treatment and extending life, for many patients with end stage disease. By excluding Lesbian and Gay patients, clinical trials are preventing access to life saving treatment. Darryl Mitteldorf, LCSW Executive Director Out With Cancer - The National LGBT Cancer Project