The FDA changes the ban on gay men donating blood—but just a little
by Larry Buhl
For advocates wanting to end the FDA’s thirty-two-year-old ban on gay or bi men (or MSMs) donating blood, it’s been one step forward, one step back.
Men who had sex with men anytime since 1977 have been barred from giving blood in the U.S., a policy forged in the early days of the AIDS crisis, when several people were infected through blood transfusions.
But 2015 is not 1983. The FDA has declared that it is open to new approaches that can guarantee that blood recipients aren’t subject to an increased risk of transmittable diseases.
Groups like the Red Cross have pressured the FDA to finally lift the ban, saying that risk of contaminating blood with HIV is infinitesimal given the advanced screening measures available.
LGBT activists have long seen the ban on gay and bi men as nonsensical and discriminatory. Women and men who have had sexual contact with someone with HIV or viral hepatitis can now give blood after waiting a year—but if they say they’re gay or bisexual, they can’t. Two gay men who have been monogamous for decades can’t donate blood, yet someone who has heterosexual sex with a commercial sex worker or someone who they know is living with HIV would only face a one-year deferral from giving blood.
Or, as many point out, a donor could simply lie. There’s no RNA test for sexual orientation.
In an acknowledgment of the advances in HIV testing, and, possibly, pressure from LGBT activists, the FDA’s Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) in November voted 16-2 to amend the longstanding policy, but not lift the ban altogether, to allow any men who have sex with men to donate blood if they have not had sex within the last twelve months. That’s similar to policies in the U.K., Australia, and Canada, and one advocated by the American Red Cross and America’s Blood Centers, a Washington-based network of 600 blood centers in the U.S. and Canada.
The committee’s recommendation was greeted with muted enthusiasm by LGBT advocates and considered a half step toward lifting the gay ban. But even that half step proved to be too much for another committee.
Less than a month later, in early December, the Blood Products Advisory Committee (BPAC), an expert committee convened by the FDA to review and evaluate data about the safety, effectiveness, and appropriate use of blood and blood products, did a reversal by refusing to recommend any change to current policy.
Saying science is clearly on their side, advocates of eliminating the ban cannot understand the FDA’s foot-dragging.
Ian Thompson, a legislative representative with the ACLU, says that people shouldn’t read too much into the BPAC’s decision to kick the can down the road.
“There is a widely shared recognition that the lifetime ban has to end. The Administration is hearing this from many sources, including blood banks and other blood organizations and LGBT allies in Congress,” Thompson tells A&U.
The FDA finally made a decision late last month and followed the ACBTSA recommendation—a one-year deferral for gay men who have not been sexually active for one year.
Thompson notes that the one-year deferral idea is still “extremely problematic and discriminatory.”
One-year wait, or risk-based assessment?
In June, 2014, the American Medical Association came out in favor of a new policy to ensure blood donation bans or deferrals are based on an individual’s level of health risks instead of sexual orientation alone. That individualized risk-assessment policy is more inclusive than the one-year wait period, and is favored by LGBT groups.
Jason Cianciotto, Director of Public Policy at GMHC, gave oral and written testimony at the December BPAC meeting, speaking in favor of a risk-based assessment for blood donation, rather than a one-year deferral.
The FDA needs to do two things right away, Cianciotto tells A&U. “One, they need to shift from an identity-based deferral system to a risk-based one that’s based on sound science. And two, it needs to update blood monitoring protocols to be in line with what other nations are doing.”
Most people would be shocked to find out that we are far behind the rest of the world in blood product monitoring, Cianciotto says.
“We don’t have a system in place to test each unit of blood. And instead of centralized testing, like Australia does, we have a decentralized network of policies and procedures that vary from region to region. The FDA is carrying forward its policy [of banning gay men] as a way to not take action and fix what they need to fix.”
Advocates for lifting the ban have a growing number of allies on Capitol Hill. Soon after the BPAC meeting in December, a group of U.S. lawmakers including Senators Elizabeth Warren (D-Mass.), Tammy Baldwin (D-Wis.), and Tom Harkin (D-Iowa), and Representatives Mike Quigley (D-Ill.) and Barbara Lee (D-Calif.), penned a letter calling on Secretary of Health and Human Services Sylvia Burwell to replace the ban with a policy based on individual risk factors. The legislators expressed deep concerns with even the ACBTSA committee recommendation of a one-year waiting period for gay men and MSMs.
From the letter: “A one-year deferral policy, like a lifetime ban, is a categorical exclusion based solely on the sex of an individual’s sexual partner, not his actual risk of carrying a transfusion-transmittable infection.”
“The ACBTSA’s proposed policy change would, in practice, leave that lifetime ban in place for the vast majority of MSM, even those who are healthy and low-risk. Both policies are discriminatory, and both approaches are unacceptable.”
The legislators also criticized the recommendation to hinge any change in the MSM blood donation policy to the establishment of a blood safety surveillance system as an arbitrary policy idea they say would contribute to unnecessary delays.
“To be clear, a comprehensive surveillance system for our blood supply is a critically important initiative to protect the blood supply from Hepatitis, HIV, and emerging diseases, and is long overdue. Years of HHS inaction on this issue is problematic, but so is the fact that ACBTSA has now suddenly chosen to make such a system a precondition of revising the donation policies specific to MSM.”
The letter was signed on by seventy-five Congressional colleagues.
Rep. Barbara Lee [A&U, October 2012] a longtime advocate of lifting the ban, released her own statement criticizing the FDA’s decision about the one-year deferral. “I am pleased to see the FDA take a step in the right direction by re-examining the outdated and discriminatory policy regarding blood donations from the MSM community.
“Yet, I remain disappointed that their recommendation continues blood donation deferrals without scientific justification….Deferral policy should only be based on actual risk factors,” Lee wrote.
What’s at stake
If the ban were completely lifted, 360,600 men might donate 615,300 additional pints of blood a year, which could help nearly two million people, according to a study released in September from the University of California at Los Angeles. That number doesn’t include the one million tissue transplants—corneas and heart valves—needed each year. A case in 2013 where a gay teen’s eyes were rejected after he committed suicide, though his heart was not, stirred anger and dismay.
The risk of getting HIV from a blood transfusion is extremely low today, about one per 2 million units of blood transfused, according to the FDA’s Web site. While every unit of donated blood is tested for the virus, there is an eleven-day window in which current tests can’t detect HIV in people who contracted it recently. Many who favor a policy change that stops short of lifting the ban on gay and bi men, say a one-year deferral period on donating would be more than adequate to ensure safety.
Josh Bloom, Director of Chemical and Pharmaceutical Sciences at the American Council on Science and Health, tells A&U that it’s reasonable to refine the FDA’s policies on blood donation.
“Even if someone isn’t telling the truth [about risky behaviors], the HIV tests today are very accurate and policies should be based on that,” Bloom says.
The blood supply will never be 100 percent safe, Bloom acknowledges. “But it’s a balancing act. You do what’s fair and reasonable, but always the policy should be based on science.”
Larry Buhl is a radio news reporter, screen- writer, and novelist living in Los Angeles. His podcast on employment issues, “Labor Pains,” can be found at www.laborpainspodcast.com.