For nearly 40 years, guidance from the US Food and Drug Administration has banned most gay men from donating blood, but from next week, the Red Cross, which provides about 40% of US blood and blood components, will use a more inclusive risk-based individual assessment to determine whether someone is eligible to give blood, regardless of sexual orientation.
The policy was created early in the Aids epidemic, when the US Surgeon-General estimated that 70% of people with HIV were gay or bisexual men.
At the time, reports CNN, blood could be screened for HIV antibodies, but the test wasn’t perfect and could not catch every HIV infection.
Over the years, blood banks became better able to screen for HIV among gay and bisexual men, but the FDA policy stayed the same.
Rather than screen people out for risky behaviour, it screened people for who they were.
Initially, gay and bisexual men who had sex with men, were banned for donating for life. Over the years, the ban has eased a little but still excluded most gay men from donating.
On 11 May, the FDA’s guidance caught up to the science – for the most part, with risk now being assessed based on behaviour rather than on orientation.
Some gay men will still be excluded, even with the update, but the FDA called the change a “significant milestone for the agency and the LGBTQI+ community”.
“The Red Cross believes this is one of the most significant changes in blood banking history,” said Rodney Wilson, a senior biomedical communications specialist with the Red Cross. “It makes blood donation more inclusive, yet also keeps the blood supply safe.”
The Red Cross says the new guidance should make nearly everyone feel welcome.
“We know that, for many decades, the FDA’s policies have obviously caused a lot of hurt to the LGBTQ community. And we recognise that, and regret that. But what we want people to know is that everyone is welcome in our mission, whether you can give blood or not,” Wilson said.
Change coming to more blood banks
The Red Cross is not the first blood bank in the US to make the change.
It’s up to individual blood centres to decide whether and when they want to do so, with some small centres able to make the transition quickly, said America’s Blood Centres Chief Medical Officer Dr Jed Gorlin.
His group is the national organisation for independent community-based blood centres.
“It takes some sensitivity training to make sure the change is rolled out in a sensitive, appropriate fashion,” he said. Most people will fill out the risk assessment electronically, “but if the computer goes down, you need staff to be ready to ask questions about anal sex without batting an eyelash”.
He believes most centres will start using the new risk assessment before the end of the year.
OneBlood, an Orlando-based non-profit that sends blood to hundreds of hospitals, will start using the more inclusive risk assessment from 21 August, while New York Blood Centre said it would welcome all eligible donors – using the new risk assessment – on 18 September.
Critics say it’s not enough
Jason Cianciotto, vice president of communications and policy at GMHC, the world’s first HIV/Aids service organisation, said that the US should have even more donors but that the FDA’s new guidance doesn’t go far enough.
“A significant proportion of LGBT people, particularly gay and bisexual men who have sex with men, will still be excluded from donating blood, and they shouldn’t be,” he said.
The updated guidance says anyone who has had a new sexual partner, more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred.
The FDA said using the three-month benchmark reduces the risk of getting a donation from someone with a recent HIV infection who may not know it yet, even if they’ve been tested.
But the guidance doesn’t take into account people who should be safe if they are using condoms in such situations, Cianciotto said.
People who take medicine like pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are also being deferred under the current policy. The FDA believes that while the medicines are safe and effective, they might cause an HIV test to show up as negative even if there is actually an infection.
The new guidelines are that people must wait three months after their last PrEP pill, or two years if they had a long-acting PrEP injection.
The Red Cross said that while it will celebrate the new FDA guidance, it knows the guidance is “not perfect”.
“There’s still work to be done to make blood donation even more inclusive,” Wilson said. The Red Cross will work with the FDA to gather more data, particularly about people on PrEP and PEP.
“Hopefully, in time, we’ll be able to eliminate that deferral as well,” he said.
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