Gay men must abstain from sex for 3 months before donating blood for coronavirus patients: New FDA rule
The US Food and Drug Administration (FDA) guidelines currently prevent men who have sex with other men from donating blood for clinical trials to treat coronavirus patients. These guidelines have been termed as discriminatory by an advocacy group. And while the FDA has now revised its regulations, it still requires gay men to abstain from sex with another man for three months before they are eligible to donate blood.
COVID-19 is currently a big threat to global health. However, no specific vaccine or treatments are presently available. The key to managing the COVID-19 pandemic could lie with those who could fight the virus and have recovered. Accordingly, many studies are analyzing convalescent plasma therapy as an option, which uses donated blood plasma from patients who have recovered from the infection. The reason: plasma from someone who has recovered from COVID-19 contains antibodies made by the immune system and used to kill the virus. This antibody-rich plasma is then transfused into someone infected with the virus in the hopes that antibodies from the recovered person can help the infected person by killing the virus the next time it attacks. In a recent study, researchers found that six days after receiving the infusion, the COVID-19 virus was undetectable in seven of the 10 patients.
Stating that gay and bisexual men are unfairly banned from donating plasma for experimental COVID-19 treatment, the Gay & Lesbian Alliance Against Defamation (GLAAD) has issued a statement saying that the FDA cannot let an “outdated and discriminatory ban on blood donations from gay and bisexual men get in the way of potentially life-saving treatment for the country’s painful current health crisis". The policy also affects other members of the LGBTQ population, as well as women who have sex with men who have sex with men, says the group.
"Gay and bi men who have recovered from COVID-19 and want to donate plasma, or who want to help contribute to a nationwide shortage of blood, are banned from doing so as a result of the FDA. Continuing to enforce this antiquated policy is dangerous, irresponsible, and flies in the face of recommendations from medical experts," says Sarah Kate Ellis, president, and CEO of GLAAD, a US-based organization. GLAAD has also launched a petition calling for an end to the current ban on blood donations by gay and bisexual men.
Blood donation guidelines for gay men
Gay and bisexual men in the US have been subject to blanket bans on donating blood since AIDS devastated the LGBTQ community in the 1980s. The FDA relaxed its guidance in 2015 but still required men to abstain from sex with another man for at least a year before they could give blood. This policy has been criticized by the American Public Health Association, which has said that it is not based on science. The experts said that instead of protecting and enhancing the nation’s blood supply, a 12-month deferral represents a missed opportunity to save the lives of people in need of blood. They emphasized the need to update the guidance and urged the FDA to base the revisions on sound, up-to-date science.
“We recognize that the recommendation to move to a 12-month deferral policy is a step forward relative to the current policy. However, such a recommendation continues to prevent low-risk individuals from contributing to our blood supply and maintains discriminatory practices based on outdated stereotypes. Instead, we strongly urge the FDA to issue guidance that is grounded in science to ensure a safe and robust blood supply," said the American Public Health Association. It added, “The selection of a donation deferral time period of 12-months is not based in science but appears to be modeled after other countries’ choices and fears.”
On March 26, a group of senators wrote a letter to the FDA calling on the blood donation policy to be overturned. They stressed that the coronavirus pandemic is increasing a nationwide shortage of donated blood needed to save lives. "We write to express our concern with the FDA’s discriminatory blood donor deferral policy for men who have sex with men, particularly in the midst of a nationwide shortage of donated blood and blood products spurred by the COVID-19 pandemic. In light of this shortage, we urge you to swiftly update blood donor deferral policies in favor of ones that are grounded in science, are based on individual risk factors, do not unfairly single out one group of individuals, and allow all healthy Americans to donate,” says the letter.
Subsequently, in light of the COVID-19 pandemic and under pressure from lawmakers, the FDA issued new guidance to ease restrictions against gay men — from 12 to 3 months. The FDA says that early implementation of the recommendations may help to address significant blood shortages during a crisis.
“The recommendations in this revised guidance reflect the Agency’s current thinking on donor deferral recommendations for individuals with increased risk for transmitting HIV infection. Based on the Agency’s careful evaluation of the available data, including data regarding the detection characteristics of nucleic acid testing, FDA expects implementation of these revised recommendations will not be associated with any adverse effect on the safety of the blood supply," says the FDA guidance, which calls “for immediate implementation". It adds, “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. In particular, there is currently an outbreak of respiratory disease caused by a novel coronavirus.”
Accordingly, the guidelines stipulate that the donor history questionnaire should include history in the past three months of sex with another man for male donors, and for female donors, a history in the past three months of sex with a man who has had sex with another man in the past three months.
It recommends including among others "a history in the past three months of exchanging sex for money or drugs, and a history in the past three months of non-prescription injection drug use. And history in the past three months of sex with any of the following individuals: a person with a history ever of a positive test for HIV, a person with a history ever of exchanging sex for money or drugs, or a person with a history ever of non-prescription injection drug use."
The FDA recommends that one should defer blood donation for three months from a man who has had sex with another man during the past three months, and from a female who has had sex during the past three months with a man who has had sex with another man in the past three months.
However, according to reports, administrative conflicts and hurdles have meant most blood banks have not yet applied the revision. "Kate Fry, the chief executive at America’s Blood Centers, estimated it will take two to three months, on average, for blood centers to update their practices and welcome gay and bisexual men who meet the new criteria,” reports The Guardian.
Talk show host Andy Cohen, who has recovered from COVID-19, recently said during an interview that he was told he is ineligible to donate his antibody-rich plasma because he is a gay man.
In a Facebook post, recovered patient Lukus Estok, who was told he appeared to be a prime candidate for plasma donation, wrote that it was made “transparently clear to me that while the screening questions had been updated (they made it clear they’d reverting those questions) they had made a mistake allowing me an appointment".
Estok described that while he was in the waiting room with other potential donors, the staff inquired why he had not donated blood since he was 18. He says the atmosphere changed completely when he volunteered the information that he is a gay man. “The tone. The facial expression (even with a mask on). The very temperature in the room appeared to change. They responded in a terse manor. 'Well you won’t be donating today'," he said in the post.
“(They explained) that while the FDA has announced (slightly) relaxed restrictions on accepting blood/plasma donations from gay/bi/MSM, the New York Blood Center had not yet elected to observe those new criteria on an administrative level. 'It’s not like flipping a light switch,' they explained to me. They had computers to update, and staff to retrain, before they could accept me for the healthy qualified donor that I am," he wrote. "I’m far from the only one experiencing this and far worse right now; here and across the country. Willing to respond in a time of crisis. And yet deemed nonessential," says Estok.