Liver, yes. Corneas, no. FDA urged to relax tissue donation ban for gay and bisexual men

The federal government in 2020 and 2023 changed its rules on organ and blood donation, reducing the restrictions on men who have had sex with another man.

But the Food and Drug Administration’s old restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Lawmakers and advocates, especially for cornea donation, want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human body.

They have been asking the FDA for years to reduce the deferral period from five years to 90 days, meaning a man who has had sex with another man would be able to donate tissue as long as such sex didn’t occur within three months of his death.

And they are frustrated. The FDA has put changes to the tissue guidance on its agenda since 2022 but has yet to act on them.

One of the loudest voices is Sheryl J. Moore, who took up the cause when her 16-year-old son died in 2013. She and a Colorado doctor named Michael Puente Jr. started a campaign called “Legalize Gay Eyes.”

Puente, an ophthalmologist with the University of Colorado School of Medicine and Children’s Hospital Colorado, said the current patchwork of donor guidelines is nonsensical.

“A gay man can donate their entire heart for transplant, but they cannot donate just the heart valve,” said Puente, who is gay. “It’s essentially a categorical ban.”

The justification for these policies, set 30 years ago as a means of preventing HIV transmission, has been undercut by the knowledge gained through scientific progress.

“It is simply unacceptable,” Rep. Joe Neguse, D-Colo., said in a statement. He was one of dozens of representatives who signed a letter in 2021 that said the policies should be based on individualized risk assessments instead.

“FDA policy should be derived from the best available science, not historic bias and prejudice,” the letter read.

The FDA said in a statement to KFF Health News that, “while the absolute risk transmission of HIV due to ophthalmic surgical procedures appears to be remote, there are still relative risks.”

The agency routinely reviews donor screening and testing “to determine what changes, if any, are appropriate based on technological and evolving scientific knowledge,” the statement said.

No more blood ban

In 2015, the FDA got rid of a policy dubbed the “blood ban,” which barred gay and bisexual men from donating blood, before replacing it in 2023 with a policy that treats all prospective donors the same. Anyone who, in the past three months, has had anal sex and a new sexual partner or more than one sexual partner is not allowed to donate. An FDA study found that a questionnaire was enough to effectively identify low-risk versus high-risk donors.

The U.S. Public Health Service adjusted the guidelines for organ donation in 2020. Nothing prevents sexually active gay men from donating their organs, though if they’ve had sex with another man in the past 30 days – down from a year – the patient set to receive the organ can decide whether to accept it.

But Puente said gay men cannot donate their corneas unless they were celibate for five years before death. He found that, in one year alone, at least 360 men were rejected as cornea donors because they had had sex with another man in the past five years, or in the past year in the case of Canadian donors.

Corneas contain no blood, nor any other bodily fluid capable of transmitting HIV. There are no known cases of a patient contracting HIV from a cornea transplant, even when those corneas came from donors of organs that did infect recipients.

Moreover, all donors, whether of blood, organs or tissue, are tested for HIV and two types of hepatitis. Such tests aren’t perfect: There is still what scientists call a “window period” following infection during which the donor’s body has not yet produced a detectable amount of virus.

But such windows are now quite narrow. Researchers with the Centers for Disease Control and Prevention found the tests commonly used to screen donors are unlikely to miss someone having HIV unless they acquired it in the two weeks preceding donation.

Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, coauthored a report last year that said “three months amply covers” the window in which someone might have the virus at levels too low for tests to pick up. Scott Haber, director of public health advocacy at the American Academy of Ophthalmology, said his group’s stance is that the tissue donation guideline “should be at least roughly in alignment” with that for blood.

Kevin Corcoran, who leads the Eye Bank Association of America, said the five-year abstinence required of corneal donors who are gay or bisexual isn’t just “badly out of date” but also impractical, requiring grieving relatives to recall five years of their loved one’s sexual history.

That’s the situation Moore found herself in on a July day in 2013.

Liver, yes; corneas, no

Alexander “AJ” Betts Jr. loved anime, show tunes and drinking soda out of the side of his mouth. He was bad at telling jokes but good at helping people: Betts once replaced his little sister’s lost birthday money with his own savings, Moore said, and enthusiastically chose to be an organ donor when he got his driver’s license.

Moore remembered telling her son to ignore the harassment by bigots at school.

“The kids in show choir had told him he’s going to hell for being gay, and he might as well just kill himself to save himself the time,” she recalled.

That summer, at 16, he did. As medical staff searched for signs of brain activity in the boy, Moore found herself answering a list of questions from the Iowa Donor Network, including, she recalled: “Is AJ gay?”

She told the network her son had never had penetrative sex. “They said, ‘We just need to know if he was gay.’ And I said, ‘Yes, he identified as gay.’ ”

The Iowa Donor Network said in a statement that the organization can’t comment on Moore’s case, but said, “We sincerely hope for a shift in FDA policy to align with the more inclusive approach seen in blood donation guidelines.”

Moore said her son’s organs helped save or prolong the lives of seven people. She sometimes exchanges messages with the woman who received Betts’ liver on Facebook.

But his corneas were rejected because of that conversation with the Iowa Donor Network about Betts’ sexuality.

“They wasted my son’s body parts,” Moore said. “I very much felt like AJ was continuing to be bullied beyond the grave.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – an independent source of health policy research, polling and journalism.

This article originally appeared on USA TODAY: FDA urged to relax tissue donation ban for gay and bisexual men