Researchers: Gays excluded from clinical trials

A group of researchers at Fox Chase Cancer Center is working on an academic paper that analyzes the exclusion of LGBT individuals and same-sex couples from clinical trials — more a trend than an occasional occurrence, they’re determining.

Brian Egleston, assistant research professor of biostatistics at the center, said he became aware of the issue when he was examining trials proposed for Fox Chase.

“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,” Egleston said.

ClinicalTrials.gov catalogs all of the U.S.-supported trials throughout the globe that receive federal or private funding. The site, which launched in 2000, is operated by the National Institutes of Health in partnership with the Food and Drug Administration.

Egleston found that LGBT individuals are excluded most frequently from couples’ studies, in particular those that examine erectile dysfunction, also known as ED. Of the 76 U.S. studies posted on the federal Web site that involve ED, 19 specify that participants must be in a heterosexual relationship.

“One in four of these ED studies excludes gay people, and I think that this is particularly important because a lot of these studies are actually prostate-cancer treatment studies,” he said. “It’s not just about Viagra or taking a pill for ED.”

As treatment for prostate cancer can result in erectile dysfunction, gay men may be excluded from studies for both. And currently, prostate cancer is the second most common cancer found in men.

The exclusion is not just limited to ED and prostate cancer, however.

A study underway at the University of North Carolina, Chapel Hill, and Duke University entitled “A Couples Approach to Enhance Breast Cancer Survivorship” states in its inclusion criteria that participants must be “living together in a committed heterosexual relationship.” The study aims to enhance communication, problem-solving skills and positive interactions between women with breast cancer and their male partners in order to stave off detrimental effects that a breast-cancer diagnosis can have on a couple.

Egleston noted that many of the studies that exclude LGBT people are spearheaded by drug companies, some of which have sites in the Philadelphia area.

Eli Lily and Company is currently testing a drug for adult Attention Deficit Hyperactivity Disorder and specifies those enrolled in the study — one leg of which is being conducted in the company’s Media location — must be in a “reciprocal relationship with a person of the opposite sex.”

Boehringer Ingelheim Pharmaceuticals recently completed a drug study to treat women with hypoactive sexual desire disorder with the criteria that the participants must be in a “monogamous, heterosexual relationship.” Boehringer’s Philadelphia site was one of 54 across the country that conducted the trials.

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 NIH started putting out rules that you can’t exclude people for race or gender unless it’s actually relevant to the study, but they’ve neglected to do that for sexual orientation,” said Roland Dunbrack, associate professor at Fox Chase. “That’s why this is able to happen; it’s not against the law or against policy right now.”

Michael Hall, medical oncologist and associate professor at the center, said he thinks the exclusion issue may be motivated by a level of institutionalized homophobia.

“A well-designed trial is always going to have exclusion criteria, but those need to be based on real science, not just on social norms or queasiness or social barriers,” Hall said. “Unless an investigator can present a good reason to exclude gay people or whoever else, then it’s not valid and shouldn’t be included. It just represents a lack of their wanting to deal with the issues.”

Egleston speculated that the requirement that patients must be in a heterosexual relationship may be widespread because the researchers who design these studies could just be simply “copying and pasting” criteria from similar studies into their own protocol, without considering how each stipulation is relevant to that specific trial.

This issue has received little to no attention either in the media or in the academic realm, Egleston said, which he thinks could have been motivated partly because details for the clinical trials were not posted in one centralized location where the public could easily access them until recently.

LGBT individuals who should have the option to enroll in studies for ED, breast cancer, ADHD or a variety of other conditions and illnesses may be unwillingly disqualifying themselves when they identify their sexual orientation, Egleston said; something he, Dunbrack and Hall are hoping to bring to light with their research.

“Patients who are being treated at centers where these trials are being opened probably don’t realize that when they’re being asked questions about marital status and relationship status, that is being used to decide if they can be enrolled in the clinical trials. Gay patients want and should have the same access to these opportunities as everyone else, and that’s clearly not the case.”

Jen Colletta can be reached at [email protected].