Here’s How Lifting Restrictions on Gay and Bisexual Men Could … – Verywell Health
Key Takeaways
- The FDA proposed loosening restrictions on blood donations from gay and bisexual men.
- A donor history questionnaire could identify people at high risk for having HIV, regardless of their sexuality or identity.
- The COVID-19 pandemic exacerbated a national blood shortage. The proposed policy would allow anyone to donate blood—regardless of their gender and sexual identity—as long as they haven’t engaged in risky sexual behavior in the past three months.
Blood banks continue to face dire shortages as supplies have failed to reach their pre-pandemic levels. This week, a fifth of blood centers nationwide had less than a day’s supply of blood, while only 29% had enough to last one to two days, according to America’s Blood Supply.
The Food and Drug Administration (FDA) is considering easing restrictions on blood donation by gay and bisexual men. The proposed rule, experts say, could increase the number of potential donors to boost the blood supply while righting a historical wrong.
Under the new rules, blood banks would likely screen all potential blood donors with the same questionnaire, regardless of their sexual orientation and gender identity. Potential donors would answer questions about recent sexual activity, travel, and other factors to identify those at high risk for carrying infectious diseases like HIV.
In the 1980s, the U.S. government prohibited men who have sex with men from donating blood for fear that HIV, the virus that causes AIDS, would taint the blood supply.
It wasn’t until 2015 that the rule changed. The FDA allowed men who have sex with men to donate if they had not had sexual contact with other men during the previous year. Faced with severe blood shortages during the COVID-19 pandemic, the government shortened the abstinence period from 12 months to three months.
The proposed rule would allow gay and bisexual men who are in monogamous relationships to give blood without abstaining from sex. The FDA is expected to issue draft guidance in the coming months.
“We all know that HIV can be transmitted to anyone, regardless of their background. This gives us a way to identify the higher risk donors and to defer those donors while accepting people for whom it’s safe to donate,” Liz Culler, MD, Chief Medical Officer at Blood Assurance, told Verywell.
LGBTQ+ advocates have long sought to change the rule, saying it stigmatizes men who have sex with men as the perpetrators of HIV spread.
“Restricting who can give blood based on who they are is rooted in stigma, not science,” Tony Morrison, senior director of communications at the LGBTQ+ advocacy group GLAAD, told Verywell in an email. “LGBTQ people are eager to not be discriminated against and want to be free to contribute to society in every way, including by donating blood.”
How Would the Change Impact the Blood Supply?
An estimated 6.8 million people in the United States, or about 3% of the population, donate blood each year, according to the American Red Cross.
Culler said that in the first 14 of her 16 years at Blood Assurance, a regional blood bank in the Southeast, she has never had to recommend a pause on elective surgeries due to a blood shortage. In the past two years, she has sent eight of those memos.
“Any change to make blood donation more inclusive would help to increase the number of eligible donors and potentially encourage more people to donate blood—all of which would be beneficial in helping to continuously maintain the stability of the blood supply,” Claudia Cohn, MD, PhD, Chief Medical Officer at the Association for the Advancement of Blood and Biotherapies, told Verywell in an email.
The U.S. could have seen nearly half a million more blood donors in 2019, had men who have sex with men been eligible to donate blood without a deferral period, according to Verywell’s analysis.
A Change to Improve Inclusion and Safety
The FDA’s proposed new guidance is based on findings from an agency-funded study of 1,600 gay and bisexual men. Researchers evaluated whether a risk assessment questionnaire would be as effective as time deferrals in identifying potential high-risk donors.
Blood banks, including the American Red Cross, contributed data to the study. In a statement to Verywell, the organization said the study results “will likely support a men who have sex with men policy change.”
The results of the study are still being evaluated by the FDA and haven’t been released to the public yet.
Canada adopted an individual risk assessment last fall, and several European countries use a similar system. The form asks questions about the potential donor’s sexual history, travel, and medical history.
“The concept of individual risk assessment has been widely discussed for years within the transfusion medicine community,” Cohn said.
This strategy could expand donor eligibility while continuing to ensure the highest level of safety for the blood supply, Cohn said. A questionnaire would first identify people at high risk of carrying certain diseases by asking if the potential donor had new or multiple sex partners in the last three months or if they had anal sex during that time period.
As an additional safety measure, blood banks then test all the blood donations for the HIV virus itself, as well as for antibodies that are created when the body is exposed to HIV.
“Testing [in the 1980s] was not as strong. Our testing has improved so much that we have an incredibly safe blood supply today,” Kate Fry, MBA, CAE, CEO of America’s Blood Centers, told Verywell. “That has been part of the reason, I think, that the FDA has been willing to look at a change.”
Lab tests can usually detect HIV in the blood within a month of exposure to the virus. Blood banks tend to defer high-risk potential donors for three months, allowing ample time for the virus to be detectable before they attempt to give blood.
“Testing is the best that has ever been, but it’s not perfect,” Culler said. “We’re being very conservative in terms of making sure we’re not collecting blood from someone who we feel would be at risk for HIV.”
Bolstering the Future Blood Supply
While the blood supply has improved since the height of the pandemic, blood banks are continuing to see the lingering impacts of the pandemic. Business- and school-based blood drives account for half of all blood donations, Fry said, and work-from-home has slowed their uptake.
Ideally, there would be a three- to five-day supply of blood ready for patients across the country. Fry said. Many blood centers now have enough inventory for less than two days.
“Every two seconds, someone in the United States needs blood. They need it for a wide variety of reasons—not just trauma, but cancer, and childbirth, and so many other needs,” Fry said. “The most important thing that people could do is just become a regular blood donor, and not wait for those emergency situations.”
“The hope is that is that we do have more people coming out to donate—that it’s viewed as a more inclusive way to give back to your community and to the patients whose lives depend on it,” Fry said.
What This Means For You
If the FDA moves forward with the individual risk assessment plan, the changes won’t be immediate. The FDA will likely issue draft guidance first and then open a public comment period before sharing its final guidance. Only then can blood centers begin updating their systems to accommodate new potential donors.
“The last thing we want is for individuals to see that final guidance and show up at blood centers en mass,” Fry said. “We want people to be aware that the best thing is to just call their local blood center and inquire about the timeline for the changes in eligibility should this go into effect.”
Methodology
To estimate how many gay and bisexual men might have donated blood in 2019 and 2017 had they not been restricted, Verywell relied on data from the biennial National Blood Collection and Utilization Survey. Using survey data, Verywell calculated the percentage of the U.S. population in each year who attempted to donate blood and the percentage of donors who successfully donated. Assuming that gay and bisexual men would attempt to donate, and successfully donate, at the same rate as the rest of the population if restrictions were lifted, those donation rates were used to calculate the number of anticipated additional donors. A 2016 meta-review of studies estimating the population of men who have sex with men in the U.S. found it to be between 3.8% to 6.4% of the national population. Verywell used these figures to estimate an upper and lower bound of gay and bisexual men who might have donated.