In 1983, months after researchers discovered the frightening AIDS virus, American health regulators decided that men who have sex with other men posed a very high risk to the blood supply, and that blood banks should bar them from donating.
Back then, researchers knew little about the virus and there was no way to screen blood for HIV. Restricting this high-risk group from giving made sense.
A lot has changed since HIV was known as "gay-related immune deficiency." For years, medical experts and gay-rights activists have said that the ban on gay and bisexual men is discriminatory and not rooted in evidence.
The US might finally see a change in policy. On November 13, a panel that advises Health and Human Services recommended lifting the ban for the first time ever. On December 2, the FDA considered their advice, with a final decision pending. Here's what you need to know:
What's the current blood-donor policy for men who have sex with men?
The Food and Drug Administration currently prohibits 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 is based on the group's heightened risk for HIV, hepatitis B, and other blood-borne infections.
Other groups that are seen as high-risk carriers for blood-borne infections are also barred from giving blood. This includes intravenous-drug abusers, sex workers, HIV-positive people, and those who received transplants of animal tissue or organs since there's still uncertainty about "risks of transmitting unknown or emerging pathogens harbored by the animal donors."
The ban effects trans women who have sex with men, too. An FDA spokesperson said, "For the purposes of determining donor eligibility, FDA believes that genetic males be considered males even after gender-altering surgery."
What new policy is being recommended?
On November 13, a panel that advises 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.
This means men who have sex with men would only be precluded from donating blood for 12 months after their last same-sex encounter. (The FDA would not say how the potential change could affect trans women.)
This was a big deal because past groups of HHS advisers voted to keep the lifetime ban in place. The latest vote reflects the fact that they think the data overwhelmingly show it's safe to change the policy.
The FDA heard the group's recommendation on December 2, and will weigh it against the scientific data and input from other stakeholders to come up with a new risk assessment about the impact of a policy change. Then, the Blood Organ and Tissue Senior Executive Council will meet to discuss the input, and the Office of the Assistant Secretary for Health will take all of the recommendations into account and make the final decision on how to proceed. The FDA would be responsible for carrying out any new policy, but would not specify when a change might arrive.
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 a 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 about a two-week window during which the current testing methods cannot detect HIV. For hepatitis B, it's about two months. So that's why 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 moving more in step with science and 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 — including, at least for now, the FDA — 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.
"FDA's primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products," the FDA website reads. "Men who have had sex with other men represent approximately two percent of the US population, yet are the population most severely affected by HIV."
Advocates for change view the lifetime bans as discriminatory because they're not based on individual behavior but 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 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.
A group of lawyers and bioethicists writing in JAMA said, "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."
The ACLU also said in a statement that "the proposed one-year deferral will prevent two men who maintain a committed, monogamous relationship from ever donating blood. This proposed policy does not distinguish between high risk and safer sex practices."
Until now, the FDA has maintained that it still hasn't figured out which eligibility questions they'd need to ask to "reliably identify" gay men who are at a lower risk of infection. But, perhaps, the solution to that problem lies in the latest evidence that caused the HHS advisory committee to finally recommend changing course.