FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men

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Rae Ellen Bichell | (TNS) KFF Health News

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

But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. They want to align the 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 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.

One of the loudest voices on lightening the restrictions is Sheryl J. Moore, who has been an advocate since her 16-year-old son’s death in 2013. Alexander “AJ” Betts Jr.’s internal organs were successfully donated to seven people, but his eyes were rejected because of a single question asked by the donor network: “Is AJ gay?”

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

Puente, a pediatric ophthalmologist with the University of Colorado School of Medicine and Children’s Hospital Colorado, said the current patchwork of donor guidelines is nonsensical considering advancements in the ability to test potential donors for HIV.

“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. Now, they are unnecessary and discriminatory in that they focus on specific groups of people rather than on specific behaviors known to heighten HIV risk, according to those who advocate for changing them.

Since 2022, the FDA’s Center for Biologics Evaluation and Research has put changes to the tissue guidance on its agenda but has yet to act on them.

“It is simply unacceptable,” Rep. Joe Neguse, D-Colo., said in a statement. He was one of dozens of Congress members who signed a letter in 2021 that said the current deferral policies perpetuate stigma against gay men and 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. The FDA provided a similar response to Neguse in 2022.

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, while men who have sex with men make up most of the nation’s new HIV diagnoses, 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 or not to accept it.

But Puente said gay men like him cannot donate their corneas unless they were celibate for five years prior to 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 past five years, or in the past year in the case of Canadian donors.

Corneas are the clear domes that protect the eyes from the outside world. They have the look and consistency of a transparent jellyfish, and transplanting one can restore a person’s sight. They contain no blood, nor any other bodily fluid capable of transmitting HIV. Scientists suspect that’s why 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.

Sheryl J. Moore has been advocating for the past decade to update the rules about gay men donating tissue since she lost her eldest son, Alexander “AJ” Betts Jr., to suicide in 2013 and his corneas went to waste. (KC McGinnis for KFF Health News/TNS)

Currently, 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 that nucleic acid tests, which are commonly used to screen donors, are unlikely to miss someone having HIV unless they acquired it in the two weeks preceding donation. Another study estimated that even if someone had sex with an HIV-positive person a couple of weeks to a month before donating, the odds are less than 1 in a million that a nucleic acid test would miss that infection.

“Very low, but not zero,” said Sridhar Basavaraju, who was one of the researchers on that study and directs the 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 has indirectly agreed. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, co-authored a report last year that said “three months amply covers” the window period in which someone might have the virus but 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 donations.

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.

Her son loved anime, show tunes, and drinking pop 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, she 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 antigay bigots at school.

Xander and Jackson Moore look through belongings in a room dedicated to Alexander “AJ” Betts Jr. at home in Des Moines, Iowa. Sheryl J. Moore said Betts was enthusiastic about becoming an organ donor when he got his driver’s license. When he died at age 16, his heart, lungs, and liver were among the organs that helped prolong the lives of seven people, but his corneas went untouched. (KC McGinnis for KFF Health News/TNS)

“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, he did. At the hospital, as medical staff searched for signs of brain activity in the boy before he died, Moore found herself answering a list of questions from Iowa Donor Network, including, she recalled: “Is AJ gay?”

“I remember very vividly saying to them, ‘Well, what do you mean by, “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 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, enabling us to honor the decision of all individuals 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 his heart and a middle-aged woman who received his liver. Moore sometimes exchanges messages with her on Facebook.

She found out a year later that her son’s corneas were rejected as donor tissue because of that conversation with Iowa Donor Network about her son’s sexuality.

“I felt like 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 of KFF — the independent source for health policy research, polling and journalism.)

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

‘Eric’ review: Cumberbatch stars in limited drama series that packs in too much

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“Eric” is a show with a lot going on.

The limited drama series from Netflix, dropping its six episodes this week, has dirty cops, corrupt politicians, greedy businessmen and child sex traffickers. Set in mid-1980s New York City, it takes on the treatment of the homeless, as well as that of homosexuals in the time of AIDS.

At its core, though, it is a portrait of a man — Benedict Cumberbatch’s Vincent — battling personal demons after his 9-year-old son, Edgar (Ivan Howe in his first screen role), goes missing.

Who, then, is Eric? Fair question.

Eric is the colorful monster dreamed up by Edgar and brought to man-sized life by Vincent, the creator of a popular puppet-based children’s TV show. Eric ALSO becomes the imagined walking embodiment of the latter’s self-loathing. Invisible to others, Vincent talks to Eric constantly, even shouting at the invisible creature in the company of others.

Again, “Eric” is a show with a lot going on.

The tradeoff of the Abi Morgan-created series biting off more than it realistically can chew is that it is seldom boring, at least not for lengthy stretches. It jumps from plot thread to plot thread, all of which will tie together well enough by the end of its half-dozen hours. A little silly at times? Arguably. But not boring.

Vincent’s show is “Good Day Sunshine,” which has been a hit for years but is suffering from declining ratings, and so he and colleague Lennie (Dan Fogler of “The Offer”) are dealing with money men who want to see some changes made.

“We have to bridge the gap between the preschoolers and the elementary kids,” one says. “That’s where the cool kids are.”

However, Vincent is resistant to the addition of elements such as beatboxing, and he voices that to all within the sound of his voice in no uncertain terms.

After heading home with Edgar and buying him a comic book at a store where he gets some booze, Vincent engages in his latest shouting match with his increasingly exhausted wife, Cassie (Gaby Hoffmann, “Winning Time: The Rise of the Lakers Dynasty”), as Edgar hides in his room and draws. Although seemingly afraid there may be a monster living under his bed, Edgar has created myriad sketches of Eric.

Benedict Cumberbatch, left, as Vincent, and Ivan Howe, as Edgar, share a scene in the first episode of Netflix’s “Eric.” (Courtesy of Netflix)

In the morning, as his parents argue about whether he’s too young for Vincent to allow to walk to school on his own, Edgar does just that — although he never makes it to school.

In this time before mobile phones, Vincent never bothers to return Cassie’s call to his workplace that day, and he arrives home to find a cop from New York’s missing persons department, Det. Michael Ledroit (McKinley Belcher III), interviewing his wife.

McKinley Belcher III portrays police Det. Michael Ledroit in “Eric.” (Courtesy of Netflix)

After Edgar’s been missing for 48 hours, a press conference is held, during which Vincent looks into the camera and pleads with his son to come home, to prove everyone wrong who believes he’s dead.

He then decides to take matters into his own hands … by creating Eric and putting him on TV with the hope Edgar will see his creation on the screen and come home. Cassie suggests upon learning of this plan that he has lost he has lost his mind. (We agree!) Plus, he’s compulsively drinking — and abusing other substances — by this point.

Cumberbatch, an actor known for portraying Doctor Strange in the Marvel Cinematic Universe as well as for his excellent work in “Sherlock” and “The Imitation Game,” is uneven here. To be fair, he has a tall task as this show’s main character, whom we need to root for even as he’s rude to people who care about him and thrashes about the Big Apple with his equally abrasive imaginary friend. (Cumberbatch goes growly and gravelly to voice Eric, who, like many of the city’s homeless, lives below ground.)

The strongest performance is turned in by Belcher (“Mercy Street,” “Ozark”). If Vincent is the show’s pulsing heartbeat, Ledroit is its soul, a closeted gay man who lives with his secret (and ill) lover, William (Mark Gillis). A former detective in the vice unit, the well-intentioned and determined Ledroit can’t stay away from a shady nightclub on Edgar’s path to school, which angers his boss (David Denman, “13 Hours: The Secret Soldiers of Benghazi”) — especially after Ledroit has a run-in with current vice cops.

More interesting on-screen work is turned in by Bamar Kane (“Father & Soldier”) as Yuusuf, a member of one of the city’s homeless communities and who becomes important in the story.

Bamar Kane and Alexis Molnar portray members of a homeless community in mid-1980s New York City in “Eric.” (Courtesy of Netflix)

While not as steady overall as Belcher’s work, “Eric” has an unmistakable consistency as a result of all the episodes being penned by Morgan (“The Hour,” “The Iron Lady”) and directed by Lucy Forbes (“The End of the F***ing World”). There is value to this feeling like a long film but only so much.

Early on, “Eric” relies too heavily on red herrings, such as the brief interest in George (Clarke Peters, “The Wire”), the superintendent of the building where the family lives, as a possible kidnapper because, in part, he’d been friendly to Edgar and let him hang out in his place.

“Eric” keeps us guessing as to what has happened to Edgar for only so long, but it doesn’t grow any stronger after the reveal.

You can’t help but appreciate the work to bring 1980s New York to the screen, including exterior scenes chock full of extras.

One of which is the climactic scene of “Eric,” which, in being true to the rest of the show, is just too much.

‘Eric’

What: Six-episode limited drama series.

Where: Netflix.

When: All episodes available May 30.

Rated: TV MA.

Stars (of four): 2.

 

Ramsey County prosecutors: St. Paul officer legally justified in shooting man in exchange of gunfire

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A St. Paul police officer who fatally shot a man, after the man shot and wounded him, was legally justified, prosecutors announced Thursday.

Officer Michael Tschida, who was shot in the leg, will not be charged in the shooting of Brandon D. Keys, 24.

The Minnesota Bureau of Criminal Apprehension investigated the December shooting in the Merriam Park neighborhood and forwarded the case to the Ramsey County attorney’s office for review. The county attorney’s office released a 38-page memo Thursday, explaining why prosecutors determined Tschida’s use of deadly force was justified under Minnesota law.

The incident began when a woman called 911 and reported that Keys, who was the father of her child was chasing her in another vehicle. She reported he had a current order for protection against him and that he had a gun. Body-worn and dash cameras released by police showed Tschida exited his squad at Cretin and Marshall avenues at 2:17 p.m. Dec. 7, after which there was an exchange of gunfire between him and Keys.

“I’m sure this incident has deeply impacted all of those involved, including our community,” Ramsey County Attorney John Choi wrote in a message about reviewing prosecutors’ work and agreeing with their decision. “The truth is that all too often police officers are called to dangerous situations having to place their lives on the line to protect those who call upon them and our community. We should appreciate this act of public service while also recognizing the deep loss that is felt by the family and friends of Mr. Keys.”

This is a breaking news story and will be updated.

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Sen. Nicole Mitchell says she won’t step down after DFL call for resignation

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State Sen. Nicole Mitchell says she won’t leave office over a felony burglary charge after officials in the Minnesota Democratic-Farmer-Labor Party called for her resignation.

Mitchell, a first-term DFL senator from Woodbury, was arrested in April after police found her inside her estranged mother’s Detroit Lakes, Minn., home. Her criminal case disrupted the final weeks of the legislative session, delaying votes and prompting ethics action from Senate Republicans.

Senate DFL leadership has stood by Mitchell, but the state party now publicly wants her to step down. In a statement released early Thursday, party chairman Ken Martin called for Mitchell’s resignation, saying the senator should be held accountable for her actions.

“While Sen. Mitchell is entitled to her day in court, her continued refusal to take responsibility for her actions is beneath her office and has become a distraction for her district and the Legislature,” he said. “Now that her constituents have had full representation through the end of the legislative session, it is time for her to resign to focus on the personal and legal challenges she faces.”

Mitchell still doesn’t plan to resign, her attorney said in a Thursday statement.

“Sen. Mitchell has heard from many in her community who support her work and believe in her right to due process under the law,” said Mitchell’s attorney Bruce Ringstrom Jr. “Therefore, until her criminal case is fully and finally adjudicated, Sen. Mitchell will continue to serve her constituents.”

April 22 arrest

It’s still not clear exactly what happened in the lead-up to Mitchell’s April 22 arrest in Detroit Lakes. But charges say Mitchell was found in her stepmother’s basement after a 911 call about a burglary. She allegedly told officers she was there to retrieve her father’s ashes after falling out of communication with her stepmother, and acknowledged she “did something bad.”

In a later statement on social media, Mitchell denied she was in the house to steal, claimed she was checking on her stepmother, who was recently diagnosed with Alzheimer’s and made no mention of the ashes.

In interviews with the Associated Press and KSTP-TV, Mitchell’s stepmother has said she fears her stepdaughter. The stepmother acknowledged to KSTP that she was recently diagnosed with Alzheimer’s, but that the disease has not progressed past its earliest stages.

Mitchell’s fellow Democrats say their colleague shouldn’t be ousted based on a charge and limited facts.

Republicans, on the other hand, want an expedited investigation into the senator and are calling for her to resign. They say she’s violated public trust and accuse her of changing her story about the incident.

The senator is next expected to appear in court in July.

Key vote in legislative session

Party leadership calling for Mitchell’s resignation comes a little week after the close of the 2024 legislative session, where her vote was key in getting partisan legislation through the Senate, where the DFL controls a one-seat majority over Republicans.

Senate Minority Leader Mark Johnson called Martin’s post-session call for Mitchell’s resignation “clear admission Democrats were so desperate to pass their highly partisan agenda they were willing to use votes of an alleged burglar to do it.”

Senate DFL leaders weren’t immediately available for comment Thursday. During session they removed Mitchell from committee assignments and private caucus meetings. But they stopped short of sacrificing their majority when her vote was still needed.

Republicans introduced measures to censure or remove Mitchell from the Senate, all that failed on party lines with Mitchell as the deciding vote. They also filed an ethics complaint that got heard at a May hearing, which didn’t result in any action.

If Mitchell steps down

If Mitchell were to step down, what happens after that depends on the timing. In most circumstances, state law requires the governor to call a special election within 35 days of vacancy in the Legislature.

So if Mitchell — or any other member of the Legislature for that matter — were to resign on or before June 8, the special election would fall on the normal election dates for the year.

In 2024, the state primary falls on Aug. 13 and the general on Nov. 5.

Another possible scenario is a vacancy after June 8, but more than 35 days before the primary. In that event, the governor could call a special election sometime in the summer.

But if a vacancy occurs too close to the primary, it could mean a delayed special election.

If a senator or representative were to step down on, say, July 31, it would mean the special election would happen after the November general election.

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