FDA's Revised Blood Donation Guidance for Gay Men Still Courts Controversy

The FDA has announced a relaxing of its restrictions on gay men being allowed to donate blood, in light of the coronavirus disease 2019 (COVID-19) pandemic. Red Cross figures in March showed a drop-off of 86,000 fewer blood donations across the United States, due to almost 2700 blood drives that had to be cancelled.

Now, instead of 1 year, if a male has had sex with another male, he need only wait 3 months to donate blood. However, controversy still surrounds the FDA’s newest guidance, as some say it is continues to be based not on fact but on prejudice. The original ban on donations was born during an era when HIV was not well understood and few men with AIDS survived.

“Here’s the thing: it never made any sense to me as to how they legitimately policed that anyway. How do they know if a gay man is gay? How do they know for a fact if whether or not potential donors have had intercourse with members of the same sex? And how recently? How do they know that the supposed straight male donors have never had sex with another man before? How do they know if they’re not bisexual?” exclaimed James W. Harcup, 43, a gay man who lives in Florida. “It just always seemed so ridiculous to me. And it’s also outrageous to assume that gay men engage in more risky sexual behavior than straight men.”

Therein lies the rub: these guidelines have remained in place for years, long after processes exist to test blood products to determine if they are safe, no matter who donates. According to the CDC, all donated blood products are tested for HIV and other pathogens, such as hepatitis C virus. The revised policy matches that in the United Kingdom, which in 2017 implemented a 3-month deferral policy for gay or bisexual men who want to donate blood.

Former blood technician, now a fitness entrepreneur and owner of anftraining.com, Alistaire Nzekio, 34, of Hightstown, New Jersey, pointed out, “The whole reason is because they think men who sleep with men are at a higher risk of getting HIV," he said. But, "whether or not you donate blood, that blood is tested and verified and checked before it’s even passed on. Just because I’m a gay man sleeping with another men does not make my blood any less clean. I think it stems from the 1980s, when the virus first came out, when people didn’t really understand it. You’re just as likely to get HIV whether you’re straight or gay.”

Men who had sex with men (MSM) after 1977 were barred from donating blood between September 1985 and December 2015, when there was a lifetime ban against donating, even if there had been one sexual encounter. The FDA reasoned this “indefinite deferment” was “due to the strong clustering of AIDS illness and the subsequent discovery of high rates of HIV infection in that population,” in background information presented in the newest guidance document.

Thirteen years after the lifetime ban was instituted, 1998 data from the Blood Donation Rules Opinion Study (BloodDROPS) showed that “the prevalence of HIV infection in male blood donors who reported that they were MSM was determined to be 0.25%, which is much lower than the estimated 11%-12% HIV prevalence in those reporting regular MSM behavior.” However, the lifetime ban remained until December 2015, at which time it was reduced to 1 year—meaning a male donor who had sex with another male had to abstain from doing so for 1 year if he wanted to give blood.

The change comes as Anthony S. Fauci, MD, director of the National Institute of Allergies and Infectious Diseases (NIAID) since 1984, has taking a leading role on President Trump’s coronavirus task force. Fauci experienced the implementation of the blood donation ban firsthand, and in a series of 2005 interviews with PBS, he described his role in brokering a role for the activists who changed the FDA’s clinical trial process.

“There was a demonstration in the early years here at the NIH, and we had everybody on campus… I always remember looking out the window and seeing them demonstrating, so I asked our chief of police to go down and ask them to get 5 or 6 of their leaders to come up and talk to me about what it is that they were concerned about,” he said. “That was the beginning of the constructive dialogue between me and the activists. … We came to an agreement that ‘I'll listen to what you have to say. If I see that there's merit in it, we'll pursue it, and if there really is no merit, I'll try and explain to you why I think there's no merit,’ because they were on base on more things than they were off base on.”

Consensus at present echoes this sentiment. Before the FDA released the revised guidelines, there was a movement among politicians to revise the restrictions. One letter from Democratic senators, who included several former presidential hopefuls, to FDA Commissioner Stephen M. Hahn, MD, noted, "It is imperative that we move away from discriminatory donor deferral policies that prohibit many healthy individuals from contributing much-needed blood and blood products." They cited a possible 355,000 fewer blood donations in light of the COVID-19 pandemic, as a major reason.

Another letter to Hahn from House Oversight and Reform Committee Chairwoman Carolyn Maloney, D-New York, and Rep. Alexandria Ocasio-Cortez, D-New York, expressed a similar opinion: “This antiquated policy is not based on current science, stigmatizes the LGBTQIA+ community, and undermines crucial efforts to increase the nation’s blood supply as the United States grapples with the coronavirus crisis. The coronavirus outbreak is almost certain to have significant, long-term impacts on the nation’s blood supply… Revising the current restriction could result in as many as an estimated 615,000 additional pints of blood being donated each year.”

In an email to The American Journal of Managed Care^®, Jon Oliveira, director of communications and membership for Garden State Equality, a New Jersey-based LGBTQ advocacy and education organization, articulated it best, acknowledging the mixed feelings surrounding this, perhaps, momentous shift in thinking: “The FDA’s decision to ease restrictions on blood donations from men who have sex with men proves what medical experts have been saying for decades: that this ban is not based in science but rather discriminatory politics. The FDA’s policy change is a sign of progress—even if forced by the needs of the current crisis—but we must follow the science and continue fighting for a complete end to this archaic, demeaning ban.”

Until that time, the revised restrictions will remain in effect through at least the 60 days after the COVID-19 emergency declaration has been lifted, at which time they will be revised again, with feedback incorporated from the public.