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Experts call for change in FDA’s MSM blood donation ban
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The FDA’s policy banning blood donations from men who have sex with men conflicts with the current science of HIV testing and transmission and should be replaced with an individual risk-based assessment that is consistent with scientific evidence, experts argued in an editorial published in The New England Journal of Medicine.
“With current, state-of-the-art HIV testing and an individual risk-based assessment, we can do better than a blanket ban,” Chana Sacks, MD, attending physician in the division of general internal medicine at Massachusetts General Hospital, told Infectious Disease News.
Sacks and colleagues noted that modern screening technologies have increased the sensitivity of HIV testing to nearly 100%, and that HIV RNA testing has dramatically reduced the window period, dropping the risk for transmission through a blood transfusion to 1 in 1.5 million.
“These advances in blood safety have everything to do with improved testing technology and nothing to do with progress in deferral practices,” they wrote.
“We have exceptional testing that is more than 99.9% sensitive after the now brief 9- to 14-day window period,” Sacks said. “Therefore, a scientifically based policy designed to protect the blood supply from HIV would aim to exclude potential donors of any sexual orientation at risk for having acquired HIV in the few weeks before donation. Currently, a heterosexual person who has had unprotected sex with many partners in the past month is allowed to donate, but a monogamous, married gay man who has repeatedly tested negative for HIV is barred.”
The results of this policy’s “flawed logic” were illustrated last summer in the wake of the Pulse nightclub shooting in Orlando, after which gay and bisexual men were unable to donate blood to help members of their own community who were targeted in the attack, Sacks and colleagues wrote. Prompted by the tragedy, 24 U.S. Senators successfully petitioned the FDA to solicit input on changing the policy.
While just the year prior, the FDA revised the policy to recommend a 1-year celibacy requirement from MSM rather than a lifetime ban, this is still “misaligned with the current science of HIV test characteristics and viral transmission,” the authors wrote.
In making the case for replacing the MSM ban with a risk-based policy, Sacks and colleagues acknowledged that the when the ban was originally instituted in 1985, it was crucial for protecting the blood supply in the early years of the AIDS epidemic.
“The beginning of the AIDS epidemic was a time of enormous fear and limited understanding of disease transmission,” Sacks said. “Given the absence of a good test for the causative virus, banning donations from populations that were disproportionately affected by AIDS was critical to creating a safer blood supply. Now, more than 30 years later, the landscape is very different, but the policy with respect to MSM donors has changed little.”
While the rationale for the MSM ban stems from the higher prevalence of HIV in this population compared with heterosexuals, the “near-perfect sensitivity of fourth-generation HIV testing” has rendered the effects of prevalence on the predictive value of a negative test result minimal or nonexistent, according to the editorial. The main risk for HIV in the blood supply is therefore linked to donation during the first weeks after infection, and accordingly, a safer policy would exclude potential donors of any sexual orientation who are at risk for having recently acquired HIV, Sacks and colleagues wrote.
“Greatest respect can be paid to the people who died and to this tragic and complicated history not by maintaining outdated policies but by constantly reevaluating and implementing changes in line with what we do know and by advancing sciences in areas we do not fully understand,” they concluded. “We must be committed to empirical rigor in the evaluation of the outcomes of any new policy changes, and in that way we can continue to ensure a safe blood supply for every person, of every community, who may need it.” – by Adam Leitenberger
Disclosures: The authors report no relevant financial disclosures.
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