As we evaluate current regulations and petition for new ones, we emphasize that the ethics surrounding blood donation policies exist at the intersection of public health and human rights and should be considered within that context. We review the current best evidence surrounding HIV testing and transmission rates, examine the limitations of the FDA’s current recommendations, and discuss the social implications of such blood donation policies. Here we propose an individual risk assessment–based screening tool as an alternative to the FDA’s current MSM deferral policy.
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In developing equitable screening practices, we must remember to continually assess standing policies and be willing to change them in light of new information. Today, testing is highly accurate and sexual preference is not synonymous with risk status. 4,5 The 3-decade span between the 1985 MSM ban and the 2015 MSM 1-year deferral policy was partly the result of the morbidity and mortality related to transfusion-associated HIV importantly, however, it also arose from homophobic public perceptions of lesbian, gay, bisexual, transgender, and queer people that led to an incoherent approach to blood donor qualification policies. There was also a perception that policymakers were slow to implement a ban on then high-risk groups, leading to thousands of new HIV cases that arose from the blood supply. At the time, the ban was necessary because HIV had not been fully characterized, no effective treatment existed, and diagnostics were severely constrained by high false-negative rates and a lengthy period between HIV infection and test positivity. The FDA officially placed the first lifelong ban on blood-product donations from MSM in 1985 during the early phase of the US AIDS epidemic. 2,4 Organizations such as the National Alliance of State and Territorial AIDS Directors and the HIV Medicine Association also addressed the issue, asking for a complete rescission of the deferral period in their comments on the most recent regulation ( ). 2 Mainstream media outlets such as NBC News and The Daily Show captured the public’s attention by opening the doors to a nationwide conversation about this policy. Despite this change, many blood centers continued to turn away MSM donors. MSM who had recovered from the novel coronavirus and had not had sex with another man in more than 3 months eagerly pursued donation at blood centers. Shortly afterward, the need for donations surged again as researchers investigated convalescent plasma as a promising therapeutic option for COVID-19. On April 3, 2020, the FDA shortened the blood donation deferral period for MSM from 1 year to 3 months. However, the deteriorating blood supply, as well as pressure from the media and various advocacy organizations, catalyzed changes in the federal recommendation. 2 According to the recommendations of the US Food and Drug Administration (FDA), men who had sex with other men within the past year were ineligible to donate and were required to stay celibate for at least a year to regain eligibility. 1 During a call for blood donations in the initial weeks of the shortage, one group was consistently denied the chance to donate solely on the basis of sexual practices: men who have sex with men (MSM).
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With social distancing measures and stay-at-home orders in effect, blood drives were cancelled citywide, cutting off more than 75% of the city’s blood supply sources. In March 2020, as COVID-19 rapidly proliferated in its new epicenter, New York City’s blood supply dwindled. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM. In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Īlthough originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education.