Thanks to an awards announcement from the National Lesbian & Gay Journalists Association, we just noticed Jen Colletta’s story in the Philadelphia Gay News about the exclusion of gays from clinical trials. Colletta won an Excellence in News Writing Award. The exclusion of gays in clinical trials is an issue that hasn’t received much mainstream attention, apart from a letter from Colletta’s sources in NEJM, a write-up by Ed Silverman and a story in The Philadelphia Inquirer.
According to Colletta, the data behind the story grew out of a chance discovery by researchers at the Fox Chase Cancer Center in Philadelphia.
“We review all the different trials that are proposed here, and they don’t necessarily open here, but a lot of them are multi-center trials so we do look at them. And I saw that we had been looking at a number of clinical trials that explicitly excluded gay people, and they didn’t necessarily open at Fox Chase, but I started to become more attuned to this and realized that this is a bigger, national issue,” (Brian Egleston, assistant research professor of biostatistics at the center) said.
The researchers analyzed trials listed in the ClinicalTrials.gov database, maintained by the National Institutes of Health and the Food and Drug Administration.
In particular, Colletta reported, homosexuals are excluded from studies about couples, especially those dealing with erectile dysfunction, which are often related to treatments for prostate cancer. It’s entirely normal for a drug trial to have exclusion criteria, but an oversight in NIH regulations mean that the exclusion of homosexuals, unlike exclusion along racial lines, can be implemented arbitrarily.
In the mid-1990s, Congress mandated that NIH establish a set of guidelines that would prevent it from excluding minorities, such as women and African Americans, from federally funded clinical trials unless there was a significant reason. There are currently no such rules regulating the inclusion of LGBT individuals.
The distribution of exclusionary studies is particularly interesting. To put it in perspective, here’s a quick visualization of the data put forth in the NEJM letter: