This new approach eliminates the rules against men who have sex with men and instead focuses on the sexual behavior of people, regardless of gender, which poses a greater risk of acquiring and infecting HIV, according to an official with direct knowledge of the program we spoke to. condition of disclosure because they are not authorized to comment. The FDA is expected to adopt the proposal after a public comment period.
Other countries including Canada and the United Kingdom have made similar changes in recent years.
For decades, gay men have said they have been made to feel like pariahs as they have been barred from performing a highly commended act of charity, ostracized from joining friends and family in donating blood after national disasters. The strictness of the FDA’s rules – which do not discriminate against those in monogamous relationships – make some feel as if they cannot be trusted or are considered carriers of disease, no matter what steps they take to protect their health.
“Keeping blood safe is important, but it’s also important to move forward so we don’t leave out a group of donors who may be completely safe,” said Claudia Cohn, chief medical officer of the Association for the Advancement of Blood and. Biotherapies, a non-profit organization that oversees the development of donor screening questions.
When the country faced a severe blood shortage in the first months of the coronavirus pandemic in 2020, Cole Williams faced an unfortunate situation. Commercials asking for blood donors were constantly playing on television. His family wanted to donate blood together. But Williams, who is bisexual and now 22, had to explain that she was ineligible because she had just she slept with a man.
“We shouldn’t have to fight this hard to do something like donate blood,” said Williams, a nursing student who founded the advocacy group Pride and Plasma to advocate for changes in FDA policy. “I could have unprotected sex with as many women as I wanted, and the FDA wouldn’t have a problem with that.”
Technological advances in blood testing and FDA funded innovation research supporting the proposed method has given full restrictions to sexually active people and bisexual men cry, say some experts. Donors who are newly eligible 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 activists say gay men will still be treated unfairly under the proposed guidelines, which would allow them to donate blood if they haven’t had a new partner in the past three months.
It’s no exception that people who take the pill every day greatly reduce their risk of contracting HIV, a landmark development that revolutionized prevention beyond relying on condoms or abstinence alone. There is no exception for those who always wear condoms. And there is no exception for those who can prove that they do not have HIV.
“Being monogamous with someone who is not living with HIV is not the only way to prevent infection,” 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 the blood donation ban.
When the AIDS epidemic broke out in the 1980s, thousands of people who received blood transfusions contracted the disease before scientists realized that the HIV virus that causes the disease can be transmitted through blood.
The FDA has placed restrictions on blood donation by gay men, who have high rates of HIV infection because the virus spreads easily through small sexual networks and more effectively during anal sex than vaginal sex. In 1985, the agency imposed a “permanent moratorium” — essentially, a lifetime ban — on donating blood to any man who had sex with another man going back to 1977. As the blood test was developed, the agency proposed a lifetime. ban in 2015, requiring instead that men who donate blood must abstain from sex with other men for 12 months.
That deferment period was reduced to three months in April 2020, as blood shortages worsen due to the coronavirus pandemic.
The new risk assessment is expected to ask potential donors, regardless of gender or sex, whether they have had a new sexual partner in the past three months, said a person familiar with the FDA’s proposal. They can bleed if they say no. Those who are have had new sexual partners they will be asked if they have had sex with them anal sex in the last three months; they don’t have it he will be asked to wait three months to donate.
The FDA declined to comment on the content of the new guidelines, first reported by the Wall Street Journal, but said they would be “gender-neutral and science-based.”
This will allow monogamous men to bleed for the first time since 1985. It may also mean that women will be prevented from bleeding for the first time if they have anal sex with a new partner, depending. in the final details of the questionnaire, although anal heterosexuality has not been a major focus of public health efforts to contain HIV.
“To reduce stigmatization by strangers, it’s worth it,” said Benjamin Brooks, director of policy and learning at Whitman-Walker, a DC-based LGBT health care organization.
Bruce Walker, director of the Ragon Institute of Massachusetts General Hospital, MIT and Harvard, said that this new policy should make blood supply safer because it expands the list of donors to more than one group and now focuses on identifying anyone who engages in dangerous sexual activities during pregnancy. three months before donating.
“We need to target those people who are at the highest risk of being in that window and prevent them from donating,” Walker said. “Until now, it has been very discriminatory because we have gone deep into things that put men at risk who have sex with men.”
Canada’s health agency approved a similar change last April.
Aditi Khandelwal, a hematologist and chief medical officer at Canadian Blood Services, an Ottawa-based non-profit organization that provides blood products, said gender-based restrictions “are wrong and do not address the risk factors of how HIV spreads.”
Howard Forman, 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 from men who have sex with men, Forman became disqualified and felt a sense of loss.
“They took something that many people find reasonable,” said Forman.
Similar stories of disappointment and rejection would play out in the following decades.
Eric Kutscher, 32, was not among his classmates at Columbia University when he joined them to donate blood in the campus gym in 2011.
When he came to the question: “Have you ever had sex with another man since 1977?” Kutscher replied “Yes.” It was then that he was told that he would not be allowed to donate.
Kutscher left the gym embarrassed and ashamed. But a few days later, he began organizing a student effort to revise the FDA’s policy on blood donors. That led to volunteer work as an HIV testing counselor, then medical school and a career in public health. Kutscher, an addiction specialist at the NYU Grossman School of Medicine, said he is looking forward to being able to donate his O, the most common blood type.
“I understand how this saves lives and I am happy to be a healthy old man 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 the first in line.”
The FDA funded the study conducted between December 2020 and September 2022 by the country’s three largest non-profit blood centers – Vitalant, OneBlood and the American Red Cross – to examine whether there are questions providers can ask gay and bisexual men to decide human risk in donating blood.
Brian Custer, director of the Vitalant Research Institute and the study’s principal investigator, declined to share the results without FDA approval. but he described them as promising.
“Obviously, when considering moving to an individualized risk-based approach, the FDA has to believe it has enough data,” Custer said.
Some of the strongest support for loosening restrictions came from the blood banks themselves.
Kate Fry, CEO of America’s Blood Centers, an association of private blood banks that provide 60 percent of the country’s supply, said the ongoing effects of the coronavirus pandemic continue to disrupt supplies. At least half of the blood centers have blood that is less than two days old three to five days is recommended.
“We are in a very challenging time for blood supply,” said Fry.
It’s unclear how much the new laws will increase the blood supply, which would require a concerted campaign to reach out to gay men who are often barred from potentially being eligible to donate.
Some critics say the three-month waiting period, similar to other Western countries, is still too strict because of advances in testing that allow early detection of HIV.
Brad Hoylman-Sigal, the top Democrat in the New York Legislature, said any repeal “continues to promote discrimination against men who have sex with men.”
“They should completely remove any such restrictions on gay men donating blood,” Hoylman-Sigal said.
The reason for the three-month postponement, according to Canada’s Khandelwal, is that testing for blood-borne pathogens, including hepatitis B and C and HIV, is “incomplete.” Although the virus can be detected in a few weeks, a three-month period provides an open “safeguard” for detecting dangerous viruses, he said.
All units of blood donated to blood banks in the United States are 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, director. health policy research at the Fenway Institute, a Boston-based group that serves the LGBT community. “The three-month postponement takes those 33 days and triples to ensure more, more caution at this time in nucleic acid testing.”
Stefan Baral, who is a professor in the department of epidemiology at Johns Hopkins University, said that the problem with blood in the US is not HIV-positive blood but the lack of donors.
“No one has been infected by a blood transfusion for more than 20 years,” said Baral. “The US has safe blood and the biggest problem with it all is that it’s not enough.”