The FDA maintains discriminatory policies regarding tissue donated to gay and bisexual men

The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, easing restrictions on men who have sex with another man.

However, FDA restrictions on donated tissues, an umbrella term that covers everything from a patient’s eyes to skin and ligaments, remain in place. In particular, advocates, lawmakers and groups focused on removing barriers to cornea donation have expressed frustration that the FDA has not heeded their calls. They want to align guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human body.

Such groups have been asking the FDA for years to shorten the deferral period from five years to 90 days, which means a man who has had sex with another man will be able to donate tissue as long as intercourse does not occur within three months of postponement dates. his death.

One of the loudest voices in favor of easing restrictions is Sheryl J. Moore, who has been an advocate since the death of her 16-year-old son in 2013. The internal organs of Alexander “AJ” Betts Jr. managed to donate to seven people, but his gaze was rejected due to one question asked by the donor network: “Is AJ gay?”

Moore and Colorado doctor Michael Puente Jr. launched a campaign called “Legalize Gay Eyes” and together they attracted the attention of national eye groups and lawmakers.

Puente, a pediatric ophthalmologist at the University of Colorado School of Medicine and Children’s Hospital Colorado, said the current patchwork of donor guidelines makes no sense given advances in the ability to test potential donors for HIV.

“A gay man can donate his whole heart for transplantation, but he cannot donate just the heart valve,” said Puente, who is gay. “It’s basically a categorical ban.”

The rationale for this policy, established 30 years ago as a means of preventing HIV transmission, has been undermined by knowledge gained from scientific advances. Supporters say the changes are unnecessary and discriminatory because they focus on specific groups of people rather than specific behaviors known to increase the risk of HIV infection.

As of 2022, the FDA’s Center for Biologics Evaluation and Research has included changes to tissue guidance on its agenda but has not yet taken any action.

“This is simply unacceptable,” Rep. Joe Neguse (D-Colo.) said in a statement. He was one of dozens of members of Congress who signed a letter in 2021 that said current deferral policies perpetuate anti-gay stigma and should instead be based on individualized risk assessments.

“FDA policy should be based on the best available science, not on biases and historical biases,” the letter says.

The FDA said in a statement to KFF Health News that “although the absolute risk of HIV transmission from ophthalmic surgery appears remote, the relative risk still exists.”

The agency routinely reviews donor screening and testing “to determine what changes, if any, are appropriate based on technology and evolving science,” the statement said. The FDA provided a similar response to Neguse in 2022.

In 2015, the FDA got rid of a policy called the “blood ban,” which barred gay and bisexual men from donating blood, before replacing it in 2023 with a policy that treats all potential donors the same. A donation cannot be made to a person who has had anal sex in the last three months and has had a new sexual partner or more than one sexual partner. The FDA study found that although men who have sex with men account for the majority of new HIV cases in the country, the questionnaire was sufficient to effectively identify low- and high-risk donors.

The US Public Health Service adjusted its organ donation guidelines in 2020. There is nothing stopping sexually active gay men from donating their organs, although if they have had sex with another man in the last 30 days – compared to a year – the patient is ready to do so the recipient of the organ may decide to accept it.

Puente, however, said homosexuals like him cannot donate their corneas unless they have been celibate for five years before their death.

He found that in one year alone, at least 360 people were rejected as cornea donors because they were men who had had sex with another man in the last five years or last year in the case of Canadian donors.

The corneas are transparent domes that protect the eyes from the outside world. They have the appearance and consistency of a transparent jellyfish, and transplantation can restore vision. They do not contain blood or any other body fluids that may transmit HIV. Scientists suspect this is why there are no known cases of HIV infection in cornea transplant patients, even if the corneas came from organ donors and actually infected the recipients.

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

But such windows are now quite narrow. Scientists at the Centers for Disease Control and Prevention have found that nucleic acid tests, which are commonly used to screen donors, are unlikely to detect a person with HIV unless he or she contracted it in the two weeks before donating blood. Another study estimated that even if someone had sex with an HIV-positive person several weeks to a month before donating blood, the chance that a nucleic acid test would not detect the infection was less than 1 in a million.

“Very low, but not zero,” said Sridhar Basavaraju, who was one of the researchers on the study and heads CDC’s Office of Blood, Organ and Other Tissue Safety. He said the risk of undetected hepatitis B is slightly higher, “but still low.”

At least one senior FDA official agreed implicitly. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, co-authored a report last year that concluded that “three months fully covers” the window period during which someone can have the virus, but in concentrations too low to be detected using tests. Scott Haber, director of public health advocacy at the American Academy of Ophthalmology, said his group’s position is that guidelines for tissue donation “should be at least approximately consistent” with those for blood donation.

Kevin Corcoran, president of the Eye Bank Association of America, said the five-year abstinence required for gay or bisexual cornea donors is not only “very outdated” but also impractical because it requires grieving relatives to recall five years of their loved one’s sexual history persons.

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

Her son loved anime, show tunes, and drinking pop out of the corner of his mouth. He wasn’t good at telling jokes, but he was good at helping people: Betts once replaced his younger sister’s lost birthday money with his own savings, she said, and after getting his driver’s license, he enthusiastically decided to become an organ donor. Moore remembers telling her son to ignore the harassment from anti-gay bigots at school.

“The choir kids told him he would go to hell for being gay and might as well kill himself to save time,” he recalled.

This summer he did just that. At the hospital, as medical staff looked for signs of the boy’s brain activity before his death, Moore answered a list of Iowa Donor Network questions, including: “Is AJ gay?”

“I remember very vividly telling them, ‘Well, what do you mean, ‘Was he gay?’ “I mean, he’s never had penetrative sex,” she said. “But 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 could not comment on Moore’s case, but said: “We sincerely hope that the FDA policy change will be consistent with the more inclusive approach evident in blood donation guidelines, allowing us to honor everyone’s decision.” who want to save lives through organ and tissue donation.

Moore said her son’s organs helped save or prolong the lives of seven other people, including a boy who received a heart transplant and a middle-aged woman who received a liver transplant. Moore sometimes exchanges messages with her on Facebook.

A year later, she learned that her son’s corneas had been rejected as donated tissue because of a conversation with the Iowa Donor Network about her son’s sexuality.

“I felt like they wasted my son’s body parts,” Moore said. “I felt like AJ was still being haunted after his death.”

KFF Health News is a national newsroom dedicated to publishing in-depth journalism on health issues and is one of the main operating programs of KFF – an independent source of research, polls and journalism on health policy. Find out more about KFF.

Subscribe KFF Health News free morning check-in.