The FDA’s new blood-screening policy includes more gays, but rejects more heterosexuals
The FDA will newly exclude from donating blood some straight people who engage in anal sex, despite 30 years of evidence that including them has not posed a risk of HIV getting into the blood supply.
After decades of LGBTQ-activist outcry, the Food and Drug Administration announced today that it has ended the unscientific—and, many gay men argue, discriminatory—wholesale exclusion of men who have sex with men from donating blood.
This exclusion—a lifetime ban established in 1985, then narrowed in recent years to “deferrals” for potential male donors reporting sex with a man within the past 12 months, then down to within three months—has sought to protect the blood supply from HIV, which transmits vastly disproportionately among gay men. But advances in HIV testing technology have rendered lengthy exclusions excessive in the face of chronic and sometimes dire blood shortages.
While the FDA’s proposed new screening guidelines for potential blood donors have finally mitigated the gay-discrimination morass, they also newly block from donating millions of heterosexuals who engage in a certain sexual act.
All U.S. blood donations are screened for HIV, as well as hepatitis B and C, using highly accurate nucleic acid tests, which can detect HIV in particular within one to two weeks of infection.
The new policy would eliminate much of the current slate of sexual screening questions. As a buffer against false-negative test results driven by very recent infections, those questions focus on behavior during the previous three months. Up until now, potential donors have been nixed if regarding this period they:
· Report sex with an HIV-positive partner
· Are a man reporting sex with another man
· Are a woman reporting sex with a man who has recently had sex with men.
Now, the FDA is, in the agency’s words, going gender inclusive.
The new sex-question system would retain the exclusion for recent sex with an HIV-positive partner. But it would otherwise only exclude potential donors who, regardless of anyone’s gender, report within three months having both:
1. A new partner or multiple partners
2. Anal intercourse.
This shift reflects a historic gay-rights victory by permitting members of monogamous, HIV-negative gay couples as well as gay men who have not recently had anal sex to donate blood (barring other exclusions, such as those tied to medications, tattooing, piercing or injection drug use). And on that front, the new policy is evidence based.
The FDA touts the proposed guidelines as on par with those recently instituted in Britain and Canada, where there have been no reported safety concerns.
But in their quest to promote equity, the new screening guidelines also send the false message that when anal sex is the potential transmission mode, gay men and heterosexuals are equally likely to contract HIV.
Anal sex does indeed transmit the virus more readily. According to a 2014 Centers for Disease Control and Prevention systematic review, when there is no form of safer-sex protection used and their partner has untreated HIV, a man or woman having receptive anal sex is estimated to be about 10 to 20 times more likely to contract the virus than: a woman having vaginal sex; or a man being the insertive anal-sex partner with a partner of either gender.
But gay men’s partners are vastly more likely to have HIV in the first place. An estimated 15% of the nation’s 4.5 million gay and bi men have the virus. In some communities, this prevalence is as high as 25% to 40%. By comparison, about 0.3% of all American adults have HIV.
According to CDC estimates, of 8,700 HIV transmissions during each three-month period in 2019:
· 6,125 (70%) were in gay or bisexual men
· 1,325 (15%) were in heterosexual women
· 600 (7%) were in straight men
· 625 (7%) were in heterosexuals who inject drugs.
Considering there are some 165 million each of heterosexual men and women, HIV transmission among them is therefore extremely rare. Dr. Patrick Sullivan, an expert in HIV surveillance statistics at Emory University, told me he estimates that men who have sex with men have a respective 400 and 190 times greater HIV acquisition rate than straight men and women.
Importantly, the blood-screening system the nation has observed to date has been highly effective at protecting the blood supply. There have been no documented transmissions of HIV or hepatitis B or C from U.S.-licensed blood transfusions in the past three decades, according to the FDA.
So, given the pressing need for more blood, the FDA only needs policies that safely expand the donor pool. With its proposed new screening policy, the agency will now broaden eligibility among gay men. However, in the policy newly excludes a subset of the many heterosexuals—at least one in three, research suggests—who engage in anal sex.
Canada instituted comparable screening questions in 2021. This has only led to the additional rejection 0.08% of actual donor applicants, far less than anticipated. But 2017 British research suggested that similar screening guidelines implemented there would newly exclude 9.3% of potential donors in the U.K. and about 1.4% to 2.3% of likely donors. This suggests that these guidelines at the very least could compromise future efforts to expand the donor pool beyond merely including more gay men.
The British study estimated that 50% to 65% of gay and bi men would be newly eligible with such screening guidelines, and that about 2% of them would donate. In the U.S., with an estimated 3.8 million HIV-negative gay and bi men, this would yield only an estimated 38,000 to 49,400 new donors among them.
Meanwhile, continuing to exclude many, but not all, gay men, is grounded in science.
The aforementioned figure of 6,125 men contracting HIV every three months—which represents approximately 1 in 620 of all HIV-negative gay and bi men—is the size of the cohort whom at any given time screening policies must continue to seek to exclude from the blood-donor pool through sexual-behavior screening as blood banks strive to include low-risk gay men.
The FDA points to a pilot study, called ADVANCE, as support for the gender-neutral, anal-sex-based screening policy. The study, which completed enrollment in September, included 1,566 gay and bi men under 40 who were interested in donating blood. It assessed a series of screening questions to determine whether they would keep the blood supply safe while allowing some gay men at low risk of HIV to donate.
The study found that 50.4% of the men were not taking PrEP. Under the FDA’s new screening rules, men who have recently taken PrEP may not donate blood, because of research suggesting that people who have recently contracted HIV while taking PrEP may have a higher likelihood of testing false negative for the virus. (Such individuals may have managed to contract HIV because of poor adherence to the drug regimen or a drug-resistant strain.)
Of the non-PrEP users in the study, 69% reported no new sexual partners or no anal sex with a new partner within three months. So 34.8% of the group would be qualified to donate blood under the new policies.
The study, which has not been peer reviewed, did not include heterosexuals. So the FDA has no U.S.-based research informing them how the new questions will impact this population, which is about 85 times larger than the population of HIV-negative gay and bi men.
In short, the new FDA policy to include more gay men in the blood-donor pool is evidence based, but the agency’s plan to newly exclude some heterosexuals who engage in anal sex is not.