The new approach eliminates rules targeting men who have sex with men, and instead focuses on sexual behaviors by people, regardless of gender, that pose a greater risk of contracting and transmitting HIV, according to an official with direct knowledge of the plan who spoke on condition. Anonymity as they are not authorized to comment. The Food and Drug Administration (FDA) is expected to adopt the proposal after a period of public comment.
Other countries including Canada and the United Kingdom have made similar changes in recent years.
For decades, gay men said they were made to feel left out as they were prevented from doing widely-praised community service, and sidelined from joining friends and family donating blood after national disasters. The strictness of the FDA’s rules—the lack of exceptions for those in monogamous relationships—has made some feel as though they can’t be trusted or seen as disease vectors, no matter what steps they take to protect their health.
said Claudia Cohn, medical director of the Association for the Advancement of Blood and Vital Therapeutics, a nonprofit organization that oversees the development of donor screening questionnaires.
When the country faced severe blood shortages in the first months of Corona Virus Pandemic In 2020, Cole Williams faced a sticky situation. Commercials asking for blood donors are constantly shown on television. His family wanted to donate blood together. But Williams, who is bisexual and now 22, had to make it clear he didn’t qualify because he had a butt. Have sex with a man.
“We shouldn’t be fighting this Jihad to do something as selfless as giving blood,” said Williams, the nursing student who formed the Pride and Plasma advocacy group to advocate for changes in FDA policy. “I could have unprotected sex with as many women as I wanted, and the FDA would have no problem with that.”
Technological advances in blood testing and new funding from the Food and Drug Administration A study supporting the proposed approach introduced a blanket ban on sexually active homosexuals And some experts said bisexual men do the talking. Newly qualified donors may not be able to donate blood Until the end of the year or early next year while the FDA finalizes the changes and blood banks implement them.
Some campaigners say gay men would still be treated unfairly under the proposed guidelines, which would allow them to donate blood if they have not had a new anal sex partner in the previous three months.
No exception is people taking a daily pill that significantly reduces the risk of contracting HIV, a landmark advance that has revolutionized prevention without relying on condoms or abstinence alone. There is no exception for those who constantly wear condoms. There is no exception for those who can present a negative HIV test.
“Monogamy with someone who does not live with HIV is not the only way to prevent transmission,” said Jason Cianciotto, vice president of communications and public policy at Gay Men’s Health Crisis, a group that has advocated for an end to blood donation bans.
When the AIDS epidemic broke out in the 1980s, thousands of people. from the public Those who received blood transfusions became infected before scientists realized that HIV, which causes the disease, could be transmitted through blood.
The FDA placed restrictions on blood donations by gay men, who had higher rates of HIV infection because the virus spreads more easily in smaller sexual networks and more efficiently. during anal sex of vaginal sex. In 1985, the agency placed an “indefinite moratorium”—in effect, a lifelong ban—on blood donations from any man who had sex with another man since 1977. As testing of the blood supply improved, the agency lifted the life. In 2015, it instead requires that men who donate blood need to abstain from sex with other men for 12 months.
This postponement period was reduced to three months in April 2020, as blood shortages became increasingly severe due to the coronavirus pandemic.
The new risk assessment is expected to ask potential donors, regardless of gender and sexual orientation, if they’ve had any new sexual partners in the past three months, said a person familiar with the FDA proposal. They can donate blood if they say no. Those Who If they have new sexual partners, they will be asked if they have engaged in sexual activity anal intercourse in the past three months; those who have You will be asked to wait three months to donate.
The FDA declined to comment on the contents of the new guidelines, first reported by the Wall Street Journal, but said they would be “gender-neutral and science-based.”
This would allow sexually active men in monogamous relationships with other men to donate blood for the first time since 1985. It could also mean that women would be barred from donating blood for the first time if they engage in anal sex with a new partner, depending on the final details of the questionnaire, though that heterosexual anal intercourse has not been a major focus of public health efforts to contain HIV.
“To reduce the stigma around gay identities, it’s worth it,” Benjamin Brooks, associate director for policy and education at Whitman Walker, a Washington-based LGBTQ health care organization.
Bruce Walker, director of the Ragon Institute at Massachusetts General Hospital, MIT and Harvard, said the new policy should make the blood supply safer as it expands the donor survey beyond a single group and now focuses on identifying anyone who has engaged in risky sexual practices within three months. before donating.
“We need to identify those people who are at high risk for staying in that period and stop them from donating,” Walker said. “Until now, it was a huge stigma because we only delved into the risk factors for men who have sex with men.”
Canada’s federal health agency authorized a similar change this past April.
Aditi Kandelwal, a hematologist and medical officer for Canadian Blood Services, an Ottawa-based nonprofit that provides blood products, said restrictions based on gender identity “are not perfect and don’t reach into risk factors for how HIV is transmitted.”
Howard Foreman, a 57-year-old Yale School of Medicine professor, began donating blood when he turned 18 in 1983, proudly carrying his donor card. But a few years after the FDA banned donations by MSM, Foreman became disqualified and felt a sense of loss.
“They took something that a lot of people found meaningful,” Foreman said.
Similar stories of disappointment and rejection would emerge over the following decades.
Eric Kutcher, 32, wasn’t out with his Columbia University classmates when he joined them to donate blood at the campus gym in 2011.
When he asked the question, “Have you had sexual intercourse with another man since 1977?” Kutcher replied, “Yes.” That’s when he was told he would not be allowed to donate.
Ashamed and embarrassed, Kutcher left the gym. But a few days later, he began organizing a student effort to revise the FDA’s policy on blood donors. This led to volunteer work as an HIV testing counselor, then medical school and a career in public health. Kutcher, an addiction medicine fellow at New York University’s Grossman School of Medicine, said he’s looking forward to being able to donate the more common O-positive blood type.
“I understand how much lives are being saved, and I am excited to be a healthy young adult who is able to provide blood to patients who need it,” he said. “As soon as I am eligible to donate blood, I will be first in line.”
Food and Drug Administration funded a study Conducted between December 2020 and September 2022 by three of the nation’s largest nonprofit blood centers—Vitalant, OneBlood, and the American Red Cross—to examine whether there were questions providers could ask sexually active gay and bisexual men to identify risk of donating blood.
Brian Caster, director of the Vitalant Research Institute and the study’s principal investigator, declined to share the results without approval from the US Food and Drug Administration (FDA). But he described them as promising.
“Obviously, if there is to be a consideration for moving to an individualized risk-based approach, the FDA must believe it has sufficient data,” Custer said.
Some of the strongest advocacy for loosening restrictions came from the blood banks themselves.
Kate Fry, chief executive of American Blood Centers, an organization of independent blood banks that provide 60 percent of the country’s supply, said the ongoing effects of the coronavirus pandemic continue to disrupt supply. At least half of the blood centers have less than 2 days worth of blood instead Three to five days is recommended.
“We’re in a very difficult time for the blood supply,” Frey said.
It is unclear how much the new rules will expand the blood supply, which would require a coordinated awareness campaign to inform gay and bisexual men who used to be banned that they may now be eligible to donate.
Mirroring other Western countries, some critics say the three-month waiting period is still too stringent because of advances in testing that allow HIV to be detected sooner.
Any delay, said Brad Hoelman-Segal, a gay Democratic senator in the New York legislature, “continues to reinforce the stigma around men who have sex with men.”
“They need to completely do away with any semblance of restrictions on gay men who donate blood,” Hoilman Segal said.
The reason for the three-month delay, according to Canada’s Khandelwal, is that testing for blood-borne viruses, which include hepatitis B and C as well as HIV, “is not ideal.” It said that while viruses can be detected in a few weeks, the three-month period provides a generous “buffer” for detecting harmful viruses.
Every unit of blood donated to a US blood bank is tested for HIV using a so-called nucleic acid test, which can detect the virus in a blood sample “within 10 to 33 days of infection,” said Sean Cahill, the director. “. of health policy research at the Fenway Institute, a Boston-based group serving the LGBT community. “A three-month delay takes 33 days and triples it to be more sure, and is very careful about this period in DNA testing.”
Stefan Barral, a professor in the department of epidemiology at Johns Hopkins University, said the problem with the blood supply in the United States is not HIV-contaminated blood, but rather a dearth of donors.
“Nobody has been infected through a blood transfusion in over 20 years,” Barral said. “The United States has a secure blood supply and the main problem with all of this is that there is not enough blood.”