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May 6, 2020 -- Jack Turban, MD, a doctor of psychiatry at Massachusetts General Hospital, knows how lucky he is to have had only a mild case of COVID-19. After getting through a cough, fatigue, and a splitting headache, the 30-year-old doctor was soon feeling back to normal.

"A few weeks into having symptoms, I saw the Journal of the American Medical Association case series that used convalescent plasma as an experimental treatment for COVID-19," he says. The idea of giving his own antibody-rich blood was appealing. "I briefly thought about donating, but quickly remembered the FDA's deferral guidance."

Turban is referring to the FDA guidance that requires a 3-month abstinence period before men who have sex with men, as well as women who have sex with bisexual men, may donate blood.

Until April 2, that abstinence period was 12 months. But as blood donations dropped during the COVID-19 pandemic, the FDA lowered that time frame by 9 months.

While it's a step in the right direction, it's not enough, says Turban. The doctor -- along with advocacy groups, other doctors and public officials -- is asking for elimination of the time deferral.

"It's so clear this is a policy that is so completely out of line with science," says Mathew Lasky, a spokesperson for GLAAD, an advocacy organization for gay, lesbian, bisexual, transgender, and queer rights. He points out that all blood donations are screened for HIV and other infections. The guidance is biased, he says, since heterosexual men, or heterosexual women who do not have sex with bisexual men, face no such time deferrals.

The FDA is launching a pilot study to determine if a risk-based questionnaire could take the place of the deferral periods.

A Growing Chorus

In March, GLAAD launched a petition calling for an end to the 12-month ban that was then in place, after U.S. Surgeon General Jerome Adams encouraged people to donate blood for the country's blood supply at a White House Coronavirus Task Force briefing.

Lasky says his group saw that call for blood donations as an ''opportunity to advocate for our community. We need all of the blood we can get." As of April 24, the petition had nearly 25,000 signatures, asking for the ban to be lifted entirely, according to GLAAD.

Support has been strong, he says, with legislators and celebrities speaking out in support and sharing the petition on social media.

In late April, Andy Cohen, host of his own show on the Bravo cable network, and a recovered COVID-19 patient eager to donate, shared his frustration about the FDA guidance. "My blood could save a life, but instead it's over here boiling," he said.

Other Outreach

On April 2, as the new guidance was issued, Patrice A. Harris, MD, president of the American Medical Association, called the revision a step in the right direction but urged the agency to ''remove the categorical restrictions'' and instead base restrictions on a person's individual risk.

More than 500 medical professionals have signed a letter sent to the FDA, urging it to overturn what it terms "the scientifically outdated” ban against men who have sex with other men -- often referred to as MSM -- from giving blood.

On April 22, the attorneys general from 20 states and the District of Columbia wrote to the U.S. Department of Health & Human Services, noting that while the 3-month delay takes a step toward increasing blood donation, "it does not go far enough."

The attorneys general urged the department to transition to a risk-based model, as other countries have done. They noted that Mexico removed a permanent ban on donation from men who have sex with men in 2012, replacing it with a screening tool for ''risky sexual practices."

The letter from the attorneys general was submitted as a response to a request for public comment on the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, according to Tara Broido, MPH, an HHS spokesperson. "HHS officials will give careful consideration to all comments received during the public comment period, which was extended until June 21, 2020."

Currently, the FDA requires that convalescent plasma only be collected from recovered COVID-19 patients if they are eligible to give blood, so the letter also asks for clarification that the new 3-month deferral period does not bar a gay man from donating convalescent plasma to his loved one.

"The FDA's 3-month deferral policy is discriminatory and not based in current science," says Turban, who wrote about the FDA policy and his personal experience with COVID-19 in a piece for Vox. He agrees that blood banks should use screening tests that are based on evidence-based risk factors, such as condom use and number of sexual partners. "This kind of strategy would better protect the blood supply and help address the ongoing blood shortage," he says. ''The deferral policy sends a message to gay and bisexual men that they can only be clean, pure, and charitable if they are sexually abstinent." Such policies, he says, amplify homophobia.

FDA's Response

The FDA is ''committed to considering alternatives to the time-based deferral for men who have sex with men," says Megan McSeveney, an FDA spokesperson. The agency has launched a pilot study that will enroll about 2,000 men who have sex with men and who would be willing to donate blood.

The study, being done at community health centers across the U.S., will use a donor questionnaire that assesses individual risk. The FDA wants to see if that approach could be as effective as time-based deferrals in reducing the risk of HIV, she says.

Asked when that study might be completed, she did not provide a specific date.

Overseeing Blood Safety, Boosting Supplies

The CDC, FDA, and National Institutes of Health work to ensure the safety of the U.S. blood supply. All blood donors are asked a set of standard questions before donating to determine if they are in good health and free of disease that could be transmitted during a transfusion. All blood is screened for infectious diseases, such as HIV, hepatitis B and C, West Nile virus, Zika virus, and other pathogens.

In their letter, the attorneys general cite a 2014 UCLA study where researchers estimated that lifting the blood donation ban for gay men completely, compared to a 12-month deferral period, would result in nearly 300,000 pints more blood donated annually.

"It seems silly to sit on this [decision] when we already have all the information," GLAAD's Lasky says.

WebMD Health News

Sources

Jack Turban, MD, resident doctor in psychiatry, Massachusetts General Hospital, Boston. 

CDC: "Blood Safety Basics," March 18, 2020.

FDA Statement: “Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic," April 2, 2020.

FDA: “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products," April 2020.

GLAAD: "GLAAD calls out FDA for 'Working to Commence a Pilot Study' To End Ban on Blood and Plasma From Gay and Bi Men," April 24, 2020.

Megan McSeveney, spokesperson, FDA.

American Medical Association: "AMA statement on new FDA guidelines for MSM blood donation," April 2, 2020.

Mathew Lasky, director of communications, GLAAD.

GLAAD.org: “Open letter to FDA from medical professionals.”

Today.com: "Andy Cohen says he couldn't donate plasma because he is gay," April 24, 2020.

The Journal of the American Medical Association: "Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma."

Tara Broido, MPH, Health & Human Services Department spokesperson.

 

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