Late last year, the Food and Drug Administration (FDA) announced that it was changing its decades-old exclusionary policy on blood donation by men who have sex with men (MSMs).
The rule — a lifetime prohibition from donating blood for MSMs — had been in place since the early 1980s, and has become a point of increasing contention, as other restrictions on lesbian, gay, bisexual, and transgender (LGBT) people are being revisited. The FDA will now allow an MSM to donate blood, but only if he has not had sex with another man in the previous twelve months. Though many welcome this change in policy, some still criticize it as too tepid and insufficiently grounded in science.
The FDA’s mission is to ensure the protection of “public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” It is also entrusted with “enhanc[ing] blood safety, and protect[ing] blood recipients.” As a result, when the possibility of HIV transmission by blood transfusion became a concern, the agency put in place rules aimed at decreasing the likelihood of such an event.
At the time, the AIDS epidemic was in its infancy and poorly understood. The public was scared. Since diagnostic tests for HIV were not immediately reliable, and effective therapeutic options were essentially absent, the FDA and blood bank organizations moved in 1983 to ban broad categories of people from being blood donors, in whom they thought the disease clustered: MSMs, intravenous (IV) drug users, Haitians, commercial sex workers, HIV-positive people, etc.
As HIV and the AIDS epidemic became better understood, regulations concerning blood donation changed. More emphasis was placed on health and behavior rather than identity, and different categories of “deferral” were created. Today, for instance, HIV-positive people are still banned, while Haitian donors are no longer prohibited from donating blood. Similarly, men who have sex with commercial sex workers, IV drug users, or an HIV-positive partner can all donate blood after 12 months, provided the sexual partner is not male.
MSMs AND THE COMING CHANGE
For MSMs, however, the ban has not changed much in the past 30 years. Before the latest announcement, any male who had had sex with another male — even once — since 1977 was barred for life from donating blood, regardless of his HIV status or individual risk exposure. The same goes for transgender women and their male partners, as well as transgender men if they’re presumed to be having sex with other men.
In light of advances in HIV detection methods, and a better understanding of the AIDS epidemic, a few countries moved to change their policies on MSM blood donation, including Canada, Britain, and South Africa, without reporting increases in HIV transmission via blood transfusion.
By some estimates, the previous lifetime ban prevented around 8.5% of U.S. men from donating blood. The newer 12-month deferral policy, in contrast, would automatically exclude fewer potential donors (around 3.8% of U.S. men).
The change in policy was not frictionless. An FDA advisory panel declined to vote in favor of it, arguing that the available scientific evidence did not warrant moving from a lifetime ban to a 12-month ban. A Health and Human Services panel came to the opposite conclusion, and nearly unanimously voted in support of the modification in deferral policy. In a somewhat surprise development, the FDA concurred with the latter panel.
AN ARBITRARY DECISION
While many agree that the FDA made the right decision, some argue that the decision itself highlights the arbitrary nature of blood donation rules, particularly as they pertain to MSMs. Though 1 year is arguably preferable to a lifetime ban, why settle on 12 months? Why not 24 months? Or 9 months? Moreover, does it really make sense to think that an HIV-negative man in a monogamous relationship with another HIV-negative man presents the same risk as an HIV-negative man who has had sex with an HIV-positive woman? (Under the new standards, they would both be deferred for 12 months). In other words, “the donor eligibility policies in place today are under-inclusive of [MSMs], since many men who are HIV-negative and at no or low-risk of becoming infected may never donate blood, while being over-inclusive of individuals in other groups who are at objectively elevated risk of contracting HIV.”
SCREEN AND DEFER VS ASSESS AND TEST
Today’s environment differs from the early 1980s in several key ways. Yet, the same policies are essentially in place or have only timidly changed. Thanks to biomedical advancements in HIV diagnosis (nucleotide-based detection by PCR is now possible, in addition to antibody-based tests), and risk-reduction strategies (pre-exposure prophylaxis or PreP, in addition to condom use), health authorities can move from the present “screen and defer” model to an “assess and test” paradigm, where, instead of being screened out of the donor pool based on criteria that may have made sense when we knew little about HIV/AIDS, an individual could be assessed as a blood donor based on our current scientific knowledge.
For instance, the suitability of a potential donor could be first assessed by a health professional; should the potential donor be cleared for blood donation, he could get tested and donate his blood, which would be stored for a period of time long enough to cover the “window period” of HIV undetectability. He could then come back after the window period since his last test at the blood center and get tested a second time, after which his stored blood could be given to patients.
A version of this new paradigm already exists in Italy, where an “individual risk assessment” policy has been in place for close to 10 years, with no evidence that an increase in HIV transmission by blood transfusion has occurred.
The United States should follow suit, and welcome the blood of all who can give it.