The United States should repeal a 30-year policy that bans blood donations from gay and bisexual men, according to a team of medical and legal experts writing this week in the Journal of the American Medical Association.
Currently, a man who has ever had sex with another man cannot donate blood in the United States -- a lifetime ban that has been in place since 1983.
The U.S. Food and Drug Administration adopted this policy at the dawn of the AIDS crisis. However, changing times and technological advances have rendered the decades-old ban obsolete, said JAMA article co-author Glenn Cohen, who directs Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics.
"We think it's time for the FDA to take a serious look at its policy, because it's out of step with peer countries, it's out of step with modern medicine, it's out of step with public opinion, and we feel it may be legally problematic," said Cohen, who co-wrote the article with Jeremy Feigenbaum of Harvard Law School and Dr. Eli Adashi of Brown University's medical school.
The lifetime ban for gay or bisexual men stands in contradiction to other FDA policies regarding people considered high-risk donors due to their sexual behavior, Cohen noted.
For example, there currently is a maximum one-year ban in the United States for blood donations by men who have had sex with an HIV-positive woman or commercial sex workers. The same goes for women who have had sex with HIV-positive men.
By implementing a lifetime ban on donation from sexually active gay or bisexual males, "you're giving a 'scarlet letter' of sorts to these men," Cohen said.
The policy also stands in stark contrast to recent advances in gay rights, and could be open to a legal challenge, given that the U.S. Supreme Court struck down the Defense of Marriage Act in 2013, he said.
Other countries have already moved to limit their bans on blood donations from gay men in recent years. Canada has changed its policy to a five-year ban, there's a one-year ban in place in the United Kingdom and a six-month ban in South Africa.
None of these countries has experienced any increase in HIV-positive blood donations, noted Dr. Steven Kleinman, a senior medical advisor to the AABB, an international non-profit blood bank association.
Current technology allows accurate detection of HIV in the bloodstream within weeks of exposure, Kleinman said. Changing the ban to six months or a year remains a conservative approach that still allows officials to prevent contamination of the blood supply, he said.
"It's correct to say that countries have made changes and so far we haven't seen any adverse effects," Kleinman added.
FDA spokeswoman Jennifer Rodriguez said that the agency is open to changing the lifetime ban and is awaiting the results of new research that will provide additional evidence.
An advisory committee to the FDA in 2010 voted in favor of retaining the existing policy. But it also found that the ban might be keeping some low-risk donors from contributing to the nation's blood supply, she said.
The committee also recommended looking at the results of studies that have been undertaken by the U.S. Department of Health and Human Services (HHS). The studies are aimed at reviewing rates of transfusion-transmitted infections and investigating whether another screening strategy for gay men could maintain the safety of the nation's blood supply, the HHS said.
Officials at HHS said the results of this research should be available by the end of 2014.
"When the results and data from the studies are available and potential policy revisions are brought forward for consideration, HHS intends to provide opportunities for discussion in a public forum," Rodriguez said.
The American Red Cross and the AABB both advocate changing the U.S. policy on donations by gay men to a one-year ban -- on par with donation policies for other high-risk groups.
But Cohen wants to go further, advocating an "assess and test" approach, in which restrictions are placed on potential blood donors based on their personal sexual practices.
Italy adopted such an approach in 2001, and "Italian data suggests there's no disproportionate increase in the number of HIV-positive donors getting into the blood supply," he said.
The AABB does not support that approach at this time, although even a one-year ban amounts to a requirement that gay men abstain from sex to be eligible to donate, Kleinman said.
"We're not requiring anyone else to be abstinent from their sexual partners of choice," he said, noting that lesbians can donate freely. "But we still find that the risk factor that accounts for the greatest proportion of cases are males who have sex with other males. That's an epidemiological fact at this point."