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FDA fast-tracked new COVID-19 rules but Seattle blood banks may take months to implement new policy for gay, bisexual men

(Image: Bloodworks Northwest)

By Dan Facundo, UW News Lab/Special to CHS

King County blood centers estimate it will take months to implement a new FDA policy for gay and bisexual male blood donors, leaving many otherwise eligible people unable to donate during the COVID-19 crisis.

As thousands of blood drives around the country have been canceled due to COVID-19, the FDA rushed out new guidelines for male blood donors who have sex with men, lowering the 12-month deferral period from their last sexual contact with a man to three months.

Despite the urgent need for blood donations, gay and bisexual men who fall under the “men who have sex with men” (MSM) umbrella will have to remain celibate for a year before they can donate blood, effectively barring them from donating and potentially turning away upwards of 345,400 pints of blood, according to a 2014 study by the Williams Institute. With modern testing able to detect HIV within as soon as 10 days of infection, many public health officials and HIV researchers think the deferral period can be reduced further. 

“We think that the window of time is enough to provide the ongoing safety of the blood supply right now where it is, without increasing risk,” said Dr. Kirsten Alcorn, Medical Director of Blood Services at Bloodworks Northwest. “It’s a very calculated risk level that needs to be backed up by lots of data.”

Under the best conditions, a policy change like this might have taken two to three months, but in light of the COVID-19 pandemic, it may take four to six months for blood centers to implement these changes as computer systems and procedures need to be updated, according to Alcorn.


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“That’s because all of our computer support for screening donors is based on whatever the current criteria are,” said Alcorn. “In order to reprogram all of that and validate that it’s working appropriately, takes a chunk of time.”

Bloodworks Northwest, which has 12 blood centers in Washington, has had to make up for an 11,000 donation shortfall after hundreds of cancellations due to COVID-19, a Bloodworks representative said in an email.

The FDA’s initial ban on blood donation for MSM began during the 1980s AIDS crisis, when the window for detecting HIV from infection to detection took several weeks. When the ban was lifted in 2015 and replaced with the 12-month deferral period, men in same-sex relationships had to abstain from sex for a year before donating blood. Men with multiple female partners are allowed to donate without a deferral period.

Many public health experts see this as an outdated policy.

“I think that it is backing out of a policy established long ago, when HIV transmission rates were greater,” said Dr. Jared Baeten, HIV researcher and Vice Dean of the School of Public Health at the University of Washington. “When understanding of the virus and its transmission was less than it is now, and when testing was less good.”

Critics of the policy have said that the FDA unfairly singles out gay men, and conflates risky sex with gay sex.

Capitol Hill resident James Clay, 32, is one of those critics. Clay can’t donate blood due to the MSM deferral policy.

“I would never, in an effort to donate blood, deny who I am as a person, whether that be lying about who I am, or my activities,” said Clay, who is gay. “They’re testing the blood for everybody regardless.”

For Clay, this not only stigmatizes MSM and MSM of color but gives heterosexual men a false sense of security. “They’re convinced that they’re safe because nobody asked them about their activities,” said Clay.

While it’s true that MSM disproportionally have the highest rates of HIV infection compared to the rest of the U.S. population and comprise the majority of new infections in Washington State,  Baeten believes that lowering the deferral period for MSM will not compromise blood safety.

“I think the FDA reducing its window, its donation guidance from a year to three months, is a step in the right direction,” said Baeten. “It just needs to take bigger steps.”

All blood donations, regardless of the donor, go through a series of tests for infectious diseases such as HIV, Hepatitis B, Hepatitis C, and Syphilis. Both the Nucleic Acid Test and the HIV antibody test are required in the U.S. under FDA guidance.

“We have highly accurate tests, including for HIV, where we have extraordinarily accurate tests that can detect infection, and detect an infection that could be transmitted,” said Baeten.

The HIV antibody test can detect antibodies 23 to 90 days after exposure, while the NAT can detect HIV infection from as early as 10 days to 33 days after exposure, narrowing the window between HIV infection and detection, according to the CDC.

But before any blood is drawn, the first line of defense is the donor history questionnaire, which assesses behaviors that are potential risks to the blood supply such as IV drug use, exchanging money for sex, and MSM.

For Clay, the behaviors of gay men are no more risky or dangerous than those of straight men.

“Why ask anybody if we’re going to rigorously test all the blood that we take in anyway?” said Clay. “Why ask anybody any questions, is my stance on it.”

“The smarter policy would be like the one the FDA already recommends for heterosexual risk,” said Baeten. “Partnerships and drug use, for example, injection drug use, and then, of course, all supported by really, really, good testing.”

While Bloodworks has a history of advocating for MSM blood donation, the FDA is the ultimate decision-maker for blood donation guidelines.

“They follow the data around the practice,” said Alcorn. “Which is part of the reason it takes so long for the FDA to make changes.”

While the three-month deferral period may sound reasonable to some, the MSM community is not homogenous. MSM in monogamous relationships who have already tested negative for HIV would still have to remain celibate in order to donate.

Some men find it offensive that in times of need, the FDA is willing to make adjustments. Clay understands why.

“You’re asking people to contribute on a personal level, to donate an actual part of themselves to a medical system that has largely abandoned gay people,” said Clay. “I can’t easily get to a doctor, period, but when I do find one, it’s not like, someone that is very well versed in gay issues.”

Luis Viquez is the Community Outreach Coordinator and tester for Seattle LGBTQ center Gay City, and he says he understands what it’s like to struggle to access services.

“I think you have to look at things from – at least the way I look at it, from a health point of view, but also from a community point of view as well,”  Viquez said.

Viquez has been with Gay City for about 17 years and has been involved with LGBTQ and minority community health for roughly 30 years. As a gay immigrant, Viquez knows first hand what it’s like to be denied access to services.

“I have tried to open doors for other things, whether it’s immigration or whether it’s access to healthcare for other things and you get a flat or round no,” said Viquez. “And it makes you feel that you don’t deserve to participate.”

The FDA is working to commence a pilot study to determine if a donor questionnaire based on individual risk assessment would be as effective as time-based deferrals in reducing the risk of HIV, according to an FDA spokesperson. The data analysis is expected to be completed in early 2021.

While blood donations for hospitals are bound by FDA guidelines, Bloodworks Northwest is accepting blood donations for research that isn’t bound by MSM policies.

“It’s been portrayed that these communities have – they’re like a disease, that they just drain the medical system, that they just take,” said Viquez. “We, the LGBTQ community, have had decades of struggle, convincing, of teaching, showing the general population that we are good people, that we are equal to you, similar to you, the same to you.”

You can learn more about donating blood at bloodworksnw.org.

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