FDA panel to review ban on blood donation from men who have gay sex

The U.S. Food and Drug Administration will convene a panel Tuesday to review its lifetime ban on blood donations from men who have had sex with a male partner — a policy that has been in place since 1983 but that advocates and public health experts say is outdated and discriminatory.

With the rise of the AIDS epidemic in the early 1980s, the FDA moved to bar blood donations from all men who had engaged in same-sex intercourse in or after 1977 — the year the epidemic began in the U.S.

At that time, men who engaged in homosexual sex were the most severely hit by HIV infection. The virus was poorly understood and the prognosis for sufferers was grim, with most dying shortly after developing AIDS — a far cry from its current status as a disease that can be managed with a diligent regimen of anti-retroviral therapy (ART). In addition, the first HIV blood test wasn’t licensed until 1985.

So while a lifetime ban on blood donation for men who have sex with men — a population often abbreviated to MSM in public health discussions — may have been prudent at the time in the United States, other countries such as Australia, Canada, Italy and the United Kingdom have since lifted their bans in favor of a system that requires that MSM blood donors abstain from sex for a period of time, usually year or more, before they can give.

“Evidence form Italy, the U.K., Canada and the like all suggest that the FDA’s current policy is an overreaction,” said I. Glenn Cohen, a professor at Harvard Law School and faculty director of the school’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. “I think it’s really more or less a no-brainer that they should move to the 12-month deferral.”

Cohen pointed out that the FDA has a 12-month deferral policy for men who have had sex with prostitutes and for women who have had sex with HIV-positive men.

He cited the example of Italy, which changed its MSM blood donation ban in 2001 to an “individual risk assessment” approach. Each potential blood donor fills out an extensive questionnaire about his sexual history and also has an in-person interview with a health care worker to determine his risk, according to a July 2014 paper co-authored by Cohen and published in the Journal of the American Medical Association.

Those men who have engaged in “high-risk behavior” such as using intravenous drugs are still permanently banned from donating in Italy. But those who engage in “risk” behavior like sex with someone with unknown HIV status are deferred for four months and then reassessed, according to the paper. A 2013 study found that the proportion of blood donated by MSM in Italy that tested HIV-positive did not significantly change after the policy was updated, implying that the individual risk assessment policy was successful.

“Italy moved away from this broad, blanket definition” of banning blood donations based on sexual orientation, Cohen said. “We think that’s really what the FDA should be doing.”

The FDA, citing the statistic that 61 percent of all new HIV infections in 2010 occurred among MSM, said on its website that the ban is based on the “documented increased risk of certain transfusion transmissible infections, such as HIV, associated with male-to-male sex and is not based on any judgment concerning the donor’s sexual orientation.”

But the American Medical Association (AMA), the American Red Cross, America’s Blood Centers and the American Association of Blood Banks have all spoken out against the policy, with the AMA calling it  “discriminatory and not based on sound science.” It is calling for a change in federal policy “to ensure blood donation bans of deferrals are applied to donors according to their individual level of risk and are not based on sexual orientation alone,” said Dr. William E. Kobler, an AMA board member, in a statement at the group’s annual meeting at 2013.

Gay rights advocates agree.

“The current lifetime ban on gay and bisexual men donating blood stigmatizes gay and bisexual men, preventing them from donating life-saving blood based solely on their sexual orientation,” David Stacy, government affairs director at the national LGBT rights group Human Rights Campaign, told Al Jazeera in an emailed statement.

Last month, an advisory panel to the Department of Health and Human Services voted overwhelmingly to lift the ban on MSM blood donation, instead recommending that people in the group ought to be able to give blood after being abstinent for a year. That was after an advisory panel to HHS voted to keep the ban in place in 2010.

The FDA screens all donated blood for HIV and Hepatitis B and C, and the risk of getting HIV from a blood transfusion is about 1 in 2 million, according to the National Institutes of Health. But it can take a few weeks or even a few months after HIV infection for antibodies to be detectable in the blood.

A 2010 study from The Williams Institute, a think tank at the UCLA School of Law that researches sexual orientation and gender identity law, found that lifting the MSM blood donation ban altogether could increase the annual U.S. blood donation supply by between 0.6 percent to 1.4 percent (PDF). That’s would amount to additional 219,200 pints of blood donated by 130,150 men who have previously been barred from doing so. And switching to the 12-month deferral would yield 89,716 more pints donated by 53,269 men.

“While these increases in the blood supply may seem modest, they would occur in an environment where blood supply shortages are common,” the authors wrote.