The Food and Drug Administration (FDA) has yet to lift its three-month celibacy requirement for donations from men who have sex with men (MSM), even on the heels of an announcement from The American Red Cross that it is experiencing a significant blood shortage including in the Philadelphia area. And according to a report from Axios, 25% of blood demand in the Philadelphia region is not being met, and blood donation centers in the region are working with less than a half day of supply.
A Red Cross statement regarding the crisis reads: “Dangerously low blood supply levels are posing a concerning risk to patient care and forcing doctors to make difficult decisions about who receives blood transfusions and who will need to wait until more products become available.”
In response to calls for the FDA to lift its policy, even long before the current blood shortage, a spokesperson from the organization said in a written statement:
“The FDA is responsible for protecting the public health by ensuring the safety of the blood supply, which depends on the implementation of donor screening measures that are based on available scientific evidence. Because of the improvements in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply is safer from infectious diseases than it has been at any other time.”
The spokesperson added that the FDA has revised its previous restrictions on blood donations from MSM, and that further changes to the policy are not out of the question. The organization lowered the abstinence requirements for MSM donors from 12 months to three months in 2020, to ensure an ample supply of blood at the start of the pandemic. Prior to that, a lifetime ban on donations from MSM had been in place until 2015, when the policy was changed to the 12-month deferral period.
But many LGBTQ+ individuals and entities have outwardly criticized the FDA for implementing a policy that they believe is rooted in discrimination rather than science.
“The FDA’s continued ban sends a message that, despite everything we know about science, some of us are not and should not be allowed to assist in a time of crisis,” Sultan Shakir, Mazzoni Center’s new president and executive director, said in an email. “It perpetrates stigma by branding one group of people — gay, bisexual, and same-gender-loving men — as vectors of disease. And, by focusing solely on sexual contact it propagates stereotypes, dehumanizes MSMs, and ignores science.”
Cameron McConkey, director of LGBTQ+ Health initiatives at Philadelphia FIGHT, is a gay man who works in HIV prevention. He gets tested for HIV on a regular basis, advises people on best HIV testing and risk curtailment practices and is a cancer survivor who has been immunosuppressed for long stretches of time, he said in an email.
“I am one of hundreds of thousands of gay men in this country who is ineligible to donate blood because of my sexual history, despite not living or being at risk of infection with HIV,” he said. “The FDA ban on blood donations from men who have had sex with another man in the last three months is not based in science. It is based in stigma. We owe the painful moments that precipitate these conversations, like the COVID pandemic and the Pulse Nightclub shooting in Orlando, more than just dialogue. There are well-studied, scientific answers to this question that the FDA throws its hands up in response to.”
In the name of science, McConkey explained that two men who are in a long term, exclusive relationship are far less likely to donate blood that carries HIV than a heterosexual man who has sex with multiple female partners and who does not use HIV prevention methods like condoms or PrEP. He also said that even a monogamous gay man with a partner who’s living with HIV but has an undetectable viral load, has no risk of acquiring HIV from his partner and thus no risk of transmitting HIV through his blood.
“That is what science tells us,” McConkey said. “And if that at all feels uneasy, you might begin to appreciate the lasting power of HIV stigma and homophobia.”
Adam Joseph, meteorologist for 6ABC in Philadelphia, also an out gay man with a personal connection to the issue, has been a vocal critic of the FDA’s policy for a while.
“I remain saddened, disgusted, yet hopeful one day the FDA will see the gay and bisexual communities as a healthy provider to help others not only in this critical time of need, but any day of the year,” Joseph said in an email. “To assume we all in the community have unhealthy blood is discriminating and hurtful. Bravo to France who this week announced the end to this ban. Come March, hundreds of thousands of Gay and Bisexual men will line up to help their country.”
Canada, Israel and Italy are other countries that employ methods of assessing the risk of individual blood donors, McConkey pointed out in his email.
On January 13, U.S. Senator Tammy Baldwin (D-WI) and 21 other senators sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock to update the blood donor deferral policies.
The letter read in part: “…any policy that continues to categorically single out the LGBTQ+ community is discriminatory and wrong. Given advances in blood screening and safety technology, a time-based policy for gay and bisexual men is not scientifically sound, continues to effectively exclude an entire group of people, and does not meet the urgent demands of the moment.”
In their statement, the FDA spokesperson included information on “alternatives to time-based deferral,” which includes the pilot study Assessing Donor Viability and New Concepts in Eligibility (ADVANCE). Its purpose is to explore whether blood donor deferral can be based on determining risk on an individual level, and will potentially enroll roughly 2,000 MSM who would consider donating blood.
“This study… could generate data that will help the FDA determine if a donor questionnaire based on individual risk assessment would be as effective as time-based deferrals in reducing the risk of HIV,” the spokesperson said.