Health

Trust-Building Sought With FDA’s Blood Donor Policy for Gay Men – Bloomberg Law

A health messaging campaign aimed at rebuilding trust with members of the LGBT community must accompany eased FDA restrictions on blood donations, infectious disease doctors and policy analysts say.

Gay and bisexual men could soon face fewer barriers to donating blood under tentative Food and Drug Administration plans for individual risk-based blood donor screening questions as a means to reduce the risk of HIV transmission. The change would mark a shift from decades-long restrictions, and would fall in line with the approach several other countries already take on donations from men who have sex with men.

But public health professionals say it’s likely that not all gay and bisexual men will be eager to line up at blood drives if the FDA eases its restrictions, citing the years of policies the LGBT community and advocacy groups have long considered discriminatory, as well as lingering stigma associated with HIV diagnosis and transmission.

A coordinated effort among federal, state, and local governments partnering with LGBT leaders will be required to communicate how improved science around HIV transmission and increased availability of treatments supports a shift in donor requirements, health workers say.

“Wearing both the hat of the public health scientist and as a gay man, I won’t be wanting to donate blood once this policy change” happens, unless “I see governmental officials and partners commit their time, resources, and energy to this initiative,” said Anthony J. Santella, a public health professor at Connecticut’s Fairfield University.

“A policy change isn’t going to overnight change how gay, bi, and other men who have sex with men feel about how we’ve been treated as a community,” added Santella, who specializes in research on infectious disease prevention and control among those living with HIV.

Under the FDA’s current policy, all men who have had sex with men in the past three months are ineligible to donate blood. While gay, bisexual, and other men who report male-to-male sexual contact are disproportionately affected by HIV, medical trade associations and LGBT advocacy groups have long railed against the blood donation limits as discriminatory and not based on science. The American Red Cross has also repeatedly called for changes to address the nationwide blood shortages, which the group labeled a national crisis earlier this year.

The FDA said it’s still reviewing results from an agency-funded study into whether reviewing potential donors on a case-by-case basis would help reduce the risk of HIV as well as time-based deferrals, and plans to issue updated draft guidance in the coming months incorporating the findings. Final study results are expected to reach the agency by the end of the year, according to the study’s website.

‘Long Overdue’

Health professionals and LGBT advocacy organizations welcomed news of the FDA’s plans, but said it would only bring federal regulations up to date with where the science and other countries have for years viewed the safety of blood donations from men who have sex with men.

“The current FDA policy is discriminatory and antiquated, and is not based in science,” said Monica Hahn, an associate clinical professor at the University of California, San Francisco, whose work focuses on HIV prevention and treatment.

Federal restrictions on blood donations from men who have sex with men stem date back to 1983, when the FDA imposed lifetime blood donation bans on gay and bisexual men in response to multiple cases in which patients became infected with HIV via transfusions. The agency lifted the ban in 2015, and said gay and bisexual men could donate blood after abstaining from sex for at least one year. The agency shortened this timeline to three months in 2020 amid nationwide blood shortages due to the Covid-19 pandemic.

In response to the 2020 change, Hahn and her medical colleagues penned an an open letter to the FDA calling on the agency to move to individual-risk based assessments for potential donors. Countries like France, Italy, and the UK have already adopted individualized risk-based approaches to blood donation criteria from gay and bisexual men.

In the letter, which was signed by more than 500 health and medical professionals, the doctors cited advancements in HIV testing that can now detect infections within days of exposure, improving the ability to maintain the safety of the US blood supply. Nucleic acid tests, which measure the virus in a person’s blood, can detect HIV as early as 10 days after exposure, according to the Centers for Disease Control and Prevention.

American Medical Association President Jack Resneck Jr. said in an emailed statement that the professional group would review the changes if and when the FDA officially proposes them, adding the plan “appears to be an encouraging step forward in removing the categorical restrictions for blood donations by men who have sex with men.”

Communicating Science

Promoting the science and medical developments that led to the FDA’s proposed plans will be integral to building trust in the agency, both among men who have sex with men and the general public.

“Part of the follow up that the governmental agencies will need to do is really take on this issue of ensuring everyone, not just gay, bisexual, other men who have sex with men, are educated about where we were, and where we are today,” Santella said.

Carlos Rodriguez-Diaz, associate professor and vice chair of the George Washington University’s Department of Prevention and Community Health, said part of the federal government’s outreach should include education on how HIV is transmitted, as well as the availability of biomedical interventions like PrEP to prevent transmission. PrEP, or pre-exposure prophylaxis, is a medicine administered by pill or shot that’s approved to reduce the risk of HIV.

“Historically, there’s been a lack of information and communication with the LGBT community in terms of their eligibility to donate blood and how they can engage in activities that actually is giving life,” Rodriguez-Diaz said.

“There are resources that are helping gay men making decisions about the likelihood of having an infection or not, and that also helps men to decide if they’re good for blood donation,” he added.

Government actions to communicate the policies can include “having community champions who really understand the policy, understand the science,” and “can have those local conversations,” Santella said. Information gathered through this outreach to members of the LGBT community can “really inform a future social marketing campaign that would be community placed, community driven.”

Sarah Warbelow, the Human Rights Campaign’s legal director, said the “best way forward to both bolster the nation’s blood supply and bring an end to an unwarranted stigma” is to combine an individual risk-based assessment questionnaire with “a robust outreach campaign to educate the public about these facts.”

‘First Step’

Health policy analysts and advocates say there’s more to be done so that other areas of policy also better reflect scientific knowledge on blood donations and HIV transmission.

“This is a great first step, and I hope that our governmental leaders take note of this and look to other issues,” including state laws on HIV transmission, Santella said.

As of 2022, a total of 35 US states have laws criminalizing or controlling actions that can potentially expose someone to HIV or sexually-transmitted diseases, like sexual activity or sharing needles, according to the CDC. The agency said many of these laws are outdated and don’t reflect the current science around HIV, and also “apply regardless of actual transmission, or intent.”

“We need policies, not just blood donation policies, but all sorts of policies related to HIV and sexual health, that are responsive to the evolution of HIV science,” Santella said.