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FDA Relaxes Blood Donation Restrictions On Gay And Bisexual Men During Shortage

Curbs on the donations were previously extended to trials on plasma from people who have recovered from COVID-19. Their antibodies could help fight the virus.

UPDATE: April 2 — The Food and Drug Administration announced Thursday that, in light of the “urgent and immediate need for blood and blood components,” it was relaxing its recommended deferral policies for gay and bisexual men.

Men who have sex with men will be allowed to donate three months after their last sexual contact, rather than the current one-year deferral. Those recommendations, it said, “reflect the agency’s current thinking on this issue” and “are expected to remain in place after the COVID-19 pandemic ends,” according to a press release. 

Additionally, the agency is loosening rules related to people who have traveled to malaria-endemic areas and will allow donations from people who have spent time in certain European countries who may have been exposed to mad cow disease.

In a press release Thursday, the FDA said it had revised its recommendations based on “recently completed studies and epidemiologic data.”

“At the FDA, we want to do everything we can to encourage more blood donations, which includes revisiting and updating some of our existing policies to help ensure we have an adequate blood supply, while still protecting the safety of our nation’s blood supply,” the agency said.

The revised rules are being issued as recommendations to blood donation centers, who can revise their own deferral policies.

PREVIOUSLY:

While 20-year-old college student Jared Bach is marooned at home in New Hampshire taking his George Washington University classes online, he’s heard the urgent calls for people to donate blood. He knows it’s one of the ways he can help, even if he jokes he’s not one for the sight of blood.

“Even though I would probably pass out, I would because it’s the right thing to do,” Bach said. “That’s what we need. That’s how I would want to help.”

However, as a gay man, Bach is barred from giving blood unless he abstains from sex for a year. The Food and Drug Administration has instituted this policy since 2015 to limit the spread of HIV. That policy has long been a grievance in the LGBTQ community, who say it is outdated and has left gay and bisexual men feeling like they can’t help in the current crisis. 

“It upsets me,” Bach said, “that because of my identity, I can’t donate right now.”

The COVID-19 pandemic has hospitals facing a potential shortage of blood supplies. At least 2,7000 Red Cross blood drives have been canceled since the beginning of March. Health care providers say they’ll need an ample supply on hand for just normal emergencies, on top of a potential need for COVID-19 patients if they require life support. 

Blood donations from gay and bisexual men are limited to donors who have abstained from sex for a year.
Blood donations from gay and bisexual men are limited to donors who have abstained from sex for a year.

Restrictions related to potential coronavirus exposure ― requiring that people wait 30 days if they have been in close contact with people suspected of having a COVID-19 infection or who have traveled to a hot spot ― have further limited donors.

NBC News reported Wednesday that the restrictions even extend to trials in which the plasma of people who have recovered from COVID-19 is collected. The plasma contains antibodies that could help infected victims fight the virus. 

GLAAD, the national LGBTQ nonprofit, has circulated a petition calling on the FDA to lift the “antiquated, discriminatory ban,” calling it “absurd” to keep in place during the crisis. Seventeen U.S. senators sent a letter last week to the FDA requesting the ban be lifted, saying the agency should adopt a policy “inclusive of all potential healthy blood donors,” and House Oversight Committee chairwoman Carolyn Maloney (D-N.Y.) and Rep. Alexandria Ocasio-Cortez (D-N.Y.) sent a similar letter Wednesday.  

In a news conference last month, Colorado Gov. Jared Polis, the nation’s first openly gay governor, lamented that even he is barred despite being in a “loving relationship for 17 years,” as even gay and bisexual men in monogamous relationships are not allowed to donate. 

“We need help from all people, and any law that gets in the way threatens public health,” Polis said. 

A 2014 study from the Williams Institute at the University of California, Los Angeles, estimated that removing the ban could increase the total annual blood supply between 2% and 4% a year. 

‘Now Is Not The Time To Experiment’

Some public health experts warn, however, that lifting the rule during a pandemic carries risks.

“The middle of a crisis is not the time to deviate from standard operating procedure. This is the time to follow the rules because these situations are when we’re most likely to make a mistake,” said Robertson Davenport, director of the blood bank and transfusion service at the University of Michigan. “I understand that it’s not entirely fair, and we could probably do a lot better, but now is not the time to experiment.”

In a statement, FDA spokesman Michael Felberbaum said “at this time, the FDA’s recommendations regarding blood donor deferral for men who have sex with men have not changed, but we are actively considering the situation as the outbreak progresses.”

Tests using plasma that might have coronavirus antibodies have also excluded gay men.
Tests using plasma that might have coronavirus antibodies have also excluded gay men.

The blood ban was first imposed at the height of the HIV/AIDS crisis, when the virus was still being studied and understood. Because men who had sex with other men (often abbreviated as MSM) showed the highest incidence of infection from HIV, which could be spread through fluid transfer, they were uniformly barred from donating. 

According to the Centers for Disease Control and Prevention, MSM and bisexual men still show the highest incidence of HIV diagnoses. However, advances in HIV testing and risk assessment have led other countries to reduce their restrictions; the U.S. reduced its prior lifetime ban to a one-year abstinence period in 2015.

The American Red Cross issued a statement last year calling for the deferral time to be reduced to three months, in line with Canada and the United Kingdom (except for Northern Ireland), while the country works on a policy that would not defer anyone based on sexual orientation. AABB (formerly the American Association of Blood Banks) also said in a statement that it supports an “updated approach to HIV risk assessment.” 

Changes On The Horizon

With backing from medical organizations and patients’ groups, the FDA is also exploring options that could replace the one-year ban. A March 2019 meeting of its Blood Products Advisory Committee discussed alternatives, such as a novel treatment to remove pathogens like the HIV virus from platelets. 

The FDA has also funded a study on using a new questionnaire that would ask more targeted questions to screen out donors at greater behavioral risk without a broader ban, which would likely allow men in monogamous relationships to donate. 

Brian Tucker, vice president of research and scientific programs at the blood donation nonprofit Vitalant and a participant in the FDA’s studies, said those pilots will help inform any FDA decision. 

“When we make a change that would be that major,” he said, “we would want to do it with the best available evidence.”

The FDA also has deferral policies on a range of issues, like incarceration within the last 12 months, travel to malaria hot spots and restrictions on those who have lived in or traveled to the United Kingdom over certain time periods, due to concerns about mad cow disease. Other countries have lifted similar restrictions in recent years. Ireland, for instance, lifted its mad cow deferrals last fall. 

Experts say it’s unlikely the FDA would adjust its policies in the midst of a public health emergency. Still, advocacy groups say they’ll use the crisis as more proof that the ban ought to be lifted. 

Rep. Chris Pappas (D-N.H.), who sent a letter in February asking the FDA to lift the ban independent of the COVID-19 need, said in an interview that the decision was “not based in science” and that the current shortage “just proves how shortsighted it is.”

“Any able-bodied person who can safely donate blood today should be able to do that,” Pappas said. “The U.S. needs to keep up with the times. This is as good a time as any to have a reckoning with a policy that is outdated.”


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