New blood donation rules leave room for LGBTQ stigma | Health Care News | The Hill

The Food and Drug Administration’s (FDA) updated blood donation guidelines were issued last month with the aim of being more inclusive of the LGBTQ community, but community members say the agency has left the door open for stigma and discrimination.

Under the new guidelines, all donors will answer a series of “individual risk-based questions” regardless of sexual orientation, sex or gender. But people who are on PrEP, the antiretroviral medicine used to prevent HIV infection, are explicitly deferred from being allowed to donate blood.

Kendall Martinez-Wright is a policy associate at the Treatment Action Group (TAG), an advocacy organization with the goal of ending diseases like HIV, tuberculosis and hepatitis. She said the policy excluding those on PrEP creates a “basis of discrimination.”

In its final guidance, the FDA cited concerns about “transfusion transmission of HIV” due to medications like PrEP resulting in false negatives. Individuals taking oral PrEP who wish to donate blood would need to abstain from taking the medicine for three months, while those who receive an injection of medicine to prevent HIV infection would need to wait at least two years to donate.

According to Rupa Patel, an infectious diseases physician and researcher at Whitman-Walker Health, if a breakthrough HIV infection were to occur in someone taking PrEP, there is a chance that person would not test positive for three months or more. 

She noted that in some cases, people taking oral PrEP never tested positive.

Traditional HIV testing looks for antibodies made in response to HIV. If the virus is blunted by PrEP, those antibodies may never be created, thus resulting in a false negative.

"People who've had exposure to antiretrovirals essentially have different patterns of disease detection," Patel said.

When taken as prescribed, PrEP reduces the risk of HIV infection by 99 percent. In these best-case scenarios, Patel describes the medicine as like a "spacesuit" or a "bubble," with the virus not having the chance to enter the body.

"We have to acknowledge that concern," Martinez-Wright said of the deferral for those on PrEP. "The modern technology that blood banks have, that can also be a segue into potential new innovative areas where they can advance testing and diagnostics, which is still an ongoing effort."

This sentiment was echoed by the Congressional Equality Caucus when the rules were finalized, with caucus Chairman Rep. Mark Pocan (D-Wis.) urging the FDA to “continue to invest in improvements in testing and pathogen reduction technologies so they can remove further barriers that may still prevent some LGBTQI+ people from donating blood.”

While understanding the need for such a rule, Martinez-Wright also expressed concerns that the guidance could inadvertently advance a false narrative that PrEP is not highly effective at reducing the risk of someone contracting HIV.

Though the agency aimed to be more inclusive of a long-excluded community, the rule on PrEP stands to still exclude large swaths of LGBTQ individuals. According to the most recent federal data, about 30 percent of people who could benefit from PrEP are taking the medication. 

The FDA has advised people not to stop taking the drug to donate blood.

On top of the exclusion of those on PrEP, individuals who have engaged in anal sex with a new partner in the past three months before donating will also be deferred. 

Among the LGBTQ community, a person in a monogamous relationship, who engages in anal sex with only their monogamous partner for three months before donating and isn’t on PrEP should be eligible as long as they meet all other criteria.

Torrian Baskerville, HIV and health equity director for the Human Rights Campaign, said a rule that requires people to go off PrEP to take part in something like blood donation is counter to the U.S.’s national goal of ending the HIV epidemic by 2030.

“We can't trade off blood donations for the sake of compromising people's health and ensuring that we are ending the epidemic by 2030,” said Baskerville.

Guidance requiring individuals to alter their behavior to take part still leaves room for discrimination, whether explicit or implicit, Baskerville said, because of the suggestion that their behavior is somehow harmful.

“We need to focus less on behavior and more on looking at technology, systems and processes that allow more people to be donors, as well as ensuring that the safety of the donations are safe for recipients to have,” he added.

With groups like the Red Cross expected to implement the changes as soon as this summer, there’s still an open question about how many gay and bisexual men will line up to donate after years of policies blocking them. 

“They don't want our blood. Why would we donate? Well, that’s the whole idea is we need to show that we are here to donate. We want to help and hopefully show them enough people want to donate,” said Jordan James, founder of the LGBTQ blood donation advocacy group Blood is Blood.

“We have a community that is willing to step up and help.”

James's organization regularly hosts blood drives in partnership with the Red Cross. According to James, many gay and bisexual men often feel, "They didn't want our blood then, they don't get it now." But this has also been the first year he has begun to hear from other organizations around the country who wish to host blood drives like his that reach out to the gay community. 

The Red Cross has said it plans to implement the new guidelines starting Aug. 7. America’s Blood Centers said shortly after the new rules were finalized that it would welcome newly eligible donors “as soon as possible.”

How these blood centers adopt the new rules and the individual risk-based questions will also determine whether more members of the LGBTQ community donate blood, according to activists.

“It's going to depend on how the questions are asked because the FDA is not going to determine how these blood banks ask the questions or what verbiage will be used specifically,” James said. “That's the next step too … how it's rolled out and how the community actually is asked, you know. Are these questions going to be more inclusive?”

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