FDA loosens ban on blood donations from gay men

LGBT, News, Politics, Rights

Gay rights have come a long way in recent years, but there’s one area in which, up until very recently, little progress had been made: since the 1980s, the Food and Drug Administration had maintained a policy known as a complete “donor deferral” of any blood or plasma donated by gay men who have ever had sexual intercourse with other men (a group referred to by the acronym MSM, which stands for “men who have sex with men”).

This policy was enacted in response to the emergence of acquired immune deficiency syndrome (AIDS). It came after medical researchers recognized that the human immunodeficiency virus (HIV; the pathogen that causes AIDS), is readily transmitted via blood and blood products, making donation protocol the highest priority for those tasked with keeping transfusion recipients safe. Accordingly, in 1985 complete donor deferrals were implemented against MSM, commercial sex workers (of any orientation), and intravenous drug users.

FDA revisits policy in 2010

After 15 years of outright refusal of blood donations from gay men, a group known as the Interagency Blood, Organ & Tissue Safety Working Group on MSM convened in 2010 to discuss possible changes to the policy. The group conducted several studies to help streamline and amend the current donation deferral criteria, as well as to ensure safe and comprehensive national blood monitoring systems. The topics studied included:

  • Donor history questionnaire: This study included both homosexual and heterosexual participants and reviewed the type of sexual health questions that would elicit the most honest responses. It revealed that general, subjective questions are more successful than literal questions like “Is your blood safe?”
  • Transfusion and transmission rates study: This highly technical research review sampled blood drawn from a variety of donors with variable risk factors, ranging from sexually active gay men to sexually abstinent donors. The data confirmed that donors with a history of sexual intercourse with HIV-positive partners were 132 times more likely to contract the virus themselves. But since such people represent a negligible fraction of the entire gay male donor population, the researchers were prompted to reconsider the deferral criteria as applied to the gay male demographic as a whole.
  • Donor evaluation study: This study reviewed the prevalence of MSM donors (which turned out to be 2.6 percent) despite knowledge of the donor deferral – and further uncovered a general consensus by gay men that the current policies were “discriminatory and stigmatizing.”

In light of these revelations concerning testing error rates, transmission risk factors, and donor feedback, researchers concluded that a change was needed – and went back to the drawing board.

Debate yields change

After conducting further extensive research-based studies, researchers convened to consider several options with regard to MSM donor deferral:

  • No deferral;
  • A one-year deferral from the time of the last homosexual intercourse;
  • A five-year deferral from the time of the last homosexual intercourse, or;
  • No change to current policy.

The group also considered implementing a deferral protocol based on risk assessment as well as the option to pre-test all potential donors, both of which were considered logically challenging and discriminatory against MSM donors.

In the end, researchers opted to implement a one-year deferral of blood and plasma donations offered by men with a sexual history involving intercourse with at least one other man in the past 12 months, as well as any female who has had sex with an MSM in the past 12 months.  Moreover, requalification of a formerly deferred donor may be possible if the donor can positively assert that he or she has not had the proscribed sexual intercourse at any point in the past 12 months.

From a global perspective, the new FDA regulations, while seemingly discriminatory on their face, comport with the donor deferral criteria of many other industrialized, developed nations. For instance, the United Kingdom, Australia, and Japan all have implemented a one-year deferral period for MSM donors. However, there is no ban at all in Italy, Mexico, Poland, Portugal, Russia, and Spain.

Many view the new regulations as a positive step, but some critics also feel the policy still reflects homophobic attitudes, particularly given the extremely low risk that HIV will be transfused in a recipient patient in light of current testing standards. Nonetheless, the move will undoubtedly help support the nation’s dwindling blood supply, and will, one hopes, encourage a renewed understanding of the importance of regular blood donation—regardless of sexual orientation or status.