After more than 30 years, the United States is finally relaxing its decades-long ban on blood donations from gay men.
The ban dates back to 1983. Months after researchers discovered the existence of HIV, US health regulators decided that men who have sex with other men posed a high risk to the blood supply and that blood banks should bar them from donating.
Back then, the reasoning was, researchers knew little about the virus, and there was no way to screen blood for HIV. But a lot has changed since — screening has gotten much better, for one. And in recent years, medical experts and gay-rights activists have said that the ban on gay and bisexual men is discriminatory and not rooted in evidence.
Today, the FDA announced that it has finalized a new policy that will allow men who have sex with men to donate. But there's still a catch: They need to abstain from sex for one year before giving blood.
What's changing about the blood donor policy for men who have sex with men?
The Food and Drug Administration has long prohibited blood donations from men who have had sex with other men even once since 1977 — the year the AIDS epidemic took off in the US. According to the FDA, this policy was based on the group's heightened risk for HIV, hepatitis B, and other blood-borne infections.
On November 13 last year, a panel that advises the Department of Health and Human Services recommended lifting the 31-year ban on blood donations from gay and bi men. The secretary's Advisory Committee on Blood and Tissue Safety and Availability met to review the latest science, and voted 16-2 to replace the ban with a one-year deferral period.
The FDA just announced that it's following that advice and moving to a one-year deferral. This means men who have sex with men will now be precluded from donating blood for 12 months after their last same-sex encounter.
What does the science say?
The current policy came into place in 1983, when little was known about the then-new HIV pathogen and there was a lot of fear about the virus. But science has progressed considerably since then.
As the authors of this JAMA article point out, we now have nucleic acid tests that diagnose an HIV infection within weeks of exposure. With few exceptions, every blood unit received at a bank has to be tested for HIV and several other pathogens before it can be used.
The scientific community also has a firmer understanding about what behaviors put people at risk for blood-borne infections, and they've developed screening tools that can determine the risk of individuals who want to donate.
Still, there remains a two-week window during which the current testing methods cannot detect HIV. For hepatitis B, it's about two months. A one-year deferral from the last sexual encounter is seen as more than enough time to catch anyone who might be at risk.
There's also good evidence to suggest a less restrictive policy wouldn't put the population at a higher risk of disease through blood transfusions. In a seminal study, the Australian Red Cross examined the impact of switching to a one-year deferral policy for men who have sex with men. Comparing five-year periods before and after the policy switch, researchers found no increase in the number of HIV-infected blood units collected, but they did find a 900,000-unit spike in blood donations.
A study on the Italian policy looked at data on the proportion of HIV-positive blood donors before (1999) and after (2009-2010) replacing their ban with an individual risk assessment in 2001. They found the change in donor policy had no impact on the blood supply.
What do other countries' policies look like?
Other countries have been replacing all-out bans with deferral periods. The UK, Australia, Sweden, and Japan have all switched to a 12-month deferral period. Canada and New Zealand have five-year deferral periods. South Africa asks donors to wait six months, and Italy bases blood donations on individual risk assessments.
What do stakeholders think about lifting the lifetime ban?
Supporters of all-out bans say men who have sex with men are still a high-risk group for blood-borne infection, and argue that continuing the prohibition protects the public.
Advocates for change view the lifetime bans as discriminatory because they're based not on individual behavior but on sexual orientation. They also argue that they're not based on science. The American Medical Association, the American Red Cross, the American Osteopathic Association, America's Blood Centers, and the American Association of Blood Banks have urged the FDA to reconsider.
But is a one-year deferral really any more science-based?
While the new policy is better than an all-out ban, some argue that the one-year deferral period seems arbitrary and that it doesn't go far enough to address the inherently discriminatory nature of the existing rule. It still excludes men in monogamous relationships, which experts say doesn't serve much of a public health purpose.
"There are irrational aspects of the policy," said Sean Cahill, director of health policy research at the Fenway Institute. "If you are a heterosexual man who admits to having unprotected sex with a sex worker or prostitute, you can wait one year and donate blood. But a gay man who has been in a monogamous relationship and who tests negative for HIV still can't."
Glenn Cohen, a Harvard Law professor who wrote about the blood donor rule in JAMA, sees a one-year deferral as an interim step, but thinks it's not any more evidence-based than the current lifetime ban. "There's no medical reason to think that a one-year deferral makes a difference as opposed to a month-long deferral when the virus would show up in blood," he explained.
A group of lawyers and bioethicists writing in JAMA seemed to agree: "Although symbolically appealing, this equally arbitrary deferral interval fails to address several of the deficiencies of the ‘screen and defer' paradigm. Indeed, it is the behavioral screen of prospective blood donors and not the length of the deferral period that is in need of reform."
Dan Bruner, senior director of policy at Whitman-Walker Health, argued for a deferral period of not more than 30 days for men who have sex with men.
"Although some may argue that a 12-month ban is better than a grossly outdated lifetime ban," he said in a statement, "the updated policy is still discriminatory and not rooted in the reality of HIV testing today."