A new pilot study funded by the Food and Drug Administration could be the first step toward lifting restrictions on blood donations by gay and bisexual men.
The program, called Assessing Donor Variability and New Concepts in Eligibility (Advance), has been launched by three of the nation’s largest blood centers — the American Red Cross, Vitalant and OneBlood.
Approximately 2,000 men who have sex with men (MSM) will be recruited at community health centers in San Francisco; Los Angeles; Memphis, Tennessee; Atlanta; Orlando, Florida; Miami; Washington, D.C.; and Baton Rouge, Louisiana. Participants must be 18 to 30, have had at least one male sex partner in the last three months and be willing to donate blood. The results could ultimately determine whether the FDA changes its blood-donor history questionnaire, asked of all potential donors to assess risk factors for infection by transfusion-transmissible diseases such as HIV and Hepatitis B.
“If the scientific evidence supports the use of the different questions, it could mean men who have sex with men who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred,” a statement on the Advance website reads.
Restrictions on certain blood donors date to the early 1980s, during the height of the AIDS epidemic in the United States, when the FDA instituted a lifetime ban on any man who had had sex with another man since 1977. That rule, intended to keep HIV out of the blood supply, was replaced in 2015 with a year-long abstinence requirement.
After the 2016 Pulse nightclub massacre in Orlando, more than 100 members of Congress — including Sens. Tammy Baldwin, D-Wis., Elizabeth Warren, D-Mass., and Bernie Sanders, I-Vt. — signed letters urging then-FDA Commissioner Dr. Robert Califf to eliminate the deferral policy.
“We can’t say some people can give blood, other people can’t based on their sexual orientation,” then-Rep. Alan Grayson, D-Fla., who represented Orlando at the time, told reporters, according to The Washington Blade.
Gay, bisexual and other men who have sex with men are the group most affected by HIV in the U.S., according to the CDC: In 2018, they accounted for 69 percent of the nearly 38,000 new HIV diagnoses across the country.
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In April, as coronavirus lockdowns caused donations to plummet, the FDA quickly lowered the eligibility requirement for MSM to just three months.
The pandemic’s impact on available blood was swift and severe: By mid-March, the American Red Cross had canceled some 2,700 blood drives, resulting in 86,000 fewer donations. In April, donations at the New York Blood Center were down from an average of 9,500 a month to fewer than 2,000, according to New York state Sen. Brad Hoylman, who is gay and was initially rejected as a donor despite meeting the new criteria. “A regular month they host about 600 blood drives,” Hoylman told NBC News in May. “Last week, they hosted two.”
The three-month deferral also affects women who have sex with MSM, sex workers, injection drug users and those with recent tattoos or piercings.
In an April letter to the FDA, two New York Democrats, Rep. Carolyn B. Maloney, chair of the Committee on Oversight and Reform, and committee member Rep. Alexandria Ocasio-Cortez, called the change “a good first step” but urged the agency to move toward assessing potential donors by individual risk.
“A policy that fails to do this perpetuates stigma and falls short of ensuring that every person who can safely donate blood in the United States has the opportunity to do so,” they said.
The Red Cross, which had encouraged the FDA to adopt the three-month deferral model, also called it “a scientifically based interim step” toward abolishing restrictions altogether.
“Blood donation eligibility should not be determined by methods that are based upon sexual orientation,” the relief organization said.
Jay Franzone, an LGBTQ advocate who remained abstinent for a year to donate blood in January 2017, said the Advance study is long overdue.
“Italy, Spain and other nations modernized their donor policies years ago, before the U.S. even ended its lifetime ban,” he told NBC News.
More than a dozen nations — including Argentina, Brazil, Mexico and Colombia — have adopted a risk-based questionnaire in place of a blanket policy based on sexual orientation. Earlier this month, the U.K. became the latest.
Franzone said he’s confident the Advance study will bear out what advocates like him have been saying all along: “Individual, risk-based assessment is safer for recipients of lifesaving blood.”
Jason Cianciotto, senior managing director of institutional development and strategy at New York’s Gay Men’s Health Crisis, said it’s exciting to reach this point after more than a decade of advocating for policy change.
He did have concerns about the Advance study, though, saying 2,000 individuals “is not a representative sample,” especially as no health centers in Chicago, New York, Boston or other Northeastern cities are involved.
He speculated that the pilot study, like the three-month deferral, was spurred by the pandemic.
“When we’ve lobbied the FDA in the past, their statements showed they didn’t really see an imperative” to change the current policy, Cianciotto told NBC News. “Even though we explained the ban contributed to stigma against people with HIV.”
A 2014 study by UCLA Law's Williams Institute found that fully repealing restrictions on gay and bisexual donors could add over a half million blood units annually, increasing the available blood supply by 2 to 4 percent.
But when advocates had mentioned gay and bisexual donors could help alleviate blood shortages, Cianciotto said, the FDA has always claimed it didn’t really have any. “Of course, no one could have predicted a nationwide shortage of blood and blood products caused by a pandemic,” he added.
That the program has started under the Trump administration, which has been accused of rolling back LGBTQ rights, increases the likelihood that it was being driven by necessity, he said.
An FDA spokesperson told NBC News that the agency “remains committed to considering alternatives to time-based deferral by generating the scientific evidence that is intended to support an individual risk-assessment-based blood donor questionnaire.”
The spokesperson indicated there is no announced timeline for the study’s completion, although ABC News reported that researchers aim to present their findings by late 2021.
Cianciotto said he hopes the program is completed and implemented before the next election.
“In a Biden administration, we’ll have an advocate like we had in the Obama administration — in fact, one who actually was in the Obama administration,” he said. “But we can’t risk this becoming a campaign issue.”