The FDA Relaxed Its Gay and Bi Blood Donor Rule. It’s Still Archaic

With blood banks and hospitals reporting shortages of blood and plasma during the COVID-19 outbreak, the Food and Drug Administration announced Thursday that it will loosen restrictions on gay and bisexual men who want to donate blood.

The FDA published revised recommendations that lower the deferral period for men who have sex with men (MSMs) from 12 months of abstinence from sex to three months. In a 20-page document, the federal agency wrote the decision was made after “careful evaluation of the available data,” which suggested that these new rules “will not be associated with any adverse effect on the safety of the blood supply.”

“Furthermore, early implementation of the recommendations in this guidance may help to address significant blood shortages that are occurring as a result of a current and ongoing public health emergency,” the FDA noted.

These changes followed a March 19 press conference from President Trump’s pandemic task force in which Surgeon General Jerome Adams called on all those who are eligible to donate after the American Red Cross reported a “severe blood shortage” amid the outbreak of COVID-19, also known as the novel coronavirus. According to the emergency relief organization, 27,000 blood drives had been cancelled after the U.S. government urged individuals to begin social distancing measures to halt the coronavirus’ spread, resulting in 86,000 fewer donations.

“Donated blood is an essential part of caring for patients, and one donation can save up to three lives,” Adams said. “Blood centers are open now and in need of your donation.”

But LGBTQ groups pointed out that some groups of people would not be able to heed that call. In 2015, the FDA rolled out policies requiring gay and bisexual men to abstain from same-sex sexual contact for a year before they were permitted to donate blood. Prior to that time, MSMs had been banned from donating altogether due to guidelines implemented during the beginning of the HIV/AIDS crisis in 1983.

In response to Adams’ statements, the LGBTQ media advocacy organization GLAAD created a petition urging the FDA to reconsider the deferral period for MSMs since the 12-month window “has been debunked by leading medical organizations for years.” The petition, which was signed by more than 20,000 people, cited opposition to the mandated year of abstinence from the American Public Health Association and American Red Cross. The former group claimed that policy was “not based in science,” while the latter added that donor eligibility should not be “based upon sexual orientation.”

Dozens of federal lawmakers joined GLAAD by writing letters calling on the FDA to revise what many saw as a de-facto lifetime ban for MSMs, given that many gay and bisexual men remain sexually active, like anyone else would. These politicians included Senators Tammy Baldwin, Bernie Sanders, and Elizabeth Warren, as well as Representatives Alexandria Ocasio-Cortez and Sean Patrick Maloney.

After the new guidelines were released on Thursday, GLAAD President and CEO Sarah Kate Ellis said she was “really heartened” by the decision, adding that “it’s been a long haul for decades.”

“I think it’s headed in the right direction, and I’m glad that they moved on it so quickly,” Ellis told VICE, noting that the petition began circulating less than two weeks ago. “This frees up a lot of blood and can potentially save a lot of lives. In a time of crisis, it seems obvious that they should be moving this forward, but for men who have been denied in the past, this is a very big deal.”

The Williams Institute, a pro-LGBTQ think tank at the University of California, Los Angeles, released a report in 2014 estimating that allowing gay and bisexual men to donate without a deferral period could result in an additional 615,300 pints available in the U.S. blood supply.

But LGBTQ advocates and medical experts said that more work needs to be done to ensure the FDA’s policies reflect recent advances in HIV screening. When the initial ban on MSM donations was implemented 37 years ago, little was known about the virus or how to test it, but today the presence of HIV can be detected within days of transmission. Estimates vary on how quickly that is, but the website for the Centers for Disease Control states that a nucleic acid test “can usually tell you if you have HIV infection 10 to 33 days after an exposure.”

“Blood tests for HIV infection are now extremely accurate and reduce any risk of collecting a contaminated unit of blood to essentially zero,” Paul Volberding, a physician and professor of epidemiology at the University of California, San Francisco School of Medicine, told VICE.

That’s why Christopher Cannon, director of research and evaluation at Whitman-Walker Health in Washington, D.C., said the FDA should move toward the risk-based screenings that have been implemented in over a dozen countries around the world, including Spain and Chile. Cannon said these assessments evaluate “different risk factors based on the number of partners or the type of sex” that potential donors are having.

“Many gay men are having safe sex with partners, so they are at no risk to the population,” Cannon told VICE. “PrEP and condom use are helping people to stay safe, and they should be prime candidates to donate.”

While the three-month deferral brings the U.S. in line with countries like Canada and the United Kingdom, there remain a number of open questions about the FDA donation guidelines. Although the FDA recommends that “male or female gender be taken to be self-identified and self-reported,” those guidelines are listed as “nonbinding,” meaning that trans women could potentially be deferred from donating under the new rules.

The FDA has reportedly taken a similar approach to early clinical trials which transfer the antibodies of COVID-19 survivors to those in the early stage of infection. Although reports broke on Tuesday that gay and bisexual men would not be permitted to participate in these potentially life-saving transfusions, GLAAD Communications Director Mathew Lasky told VICE that the FDA is now saying that it’s “up to the individual centers” to determine eligibility for such experiments.

The FDA did not return request for comment from VICE to confirm or clarify its guidelines on transgender donors or MSMs participating in COVID-19 clinical trials.

But LGBTQ advocates remain optimistic that further progress is headed down the pipeline. Peter Marks, Ph.D., head of the FDA’s Center for Biologics Evaluation and Research, told reporters on Thursday that the three-month deferral period is not the “final resting place of where this policy will be,” and Ellis said it’s critical for the U.S. government to follow through on that pledge.

“Donating blood is a way to give life to other people, to be part of a bigger community, and to help other people in need,” she said. “It's vital that we are participating in that. It's a small act that goes a very long way.”

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