7/14/2021 0 Comments
ADVANCE to Advancement? Does an FDA study forge a path toward progress or highlight a repressive system against men who have sex with men?
Evan Hall (he/they)
The U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) issued “Revised Recommendations for Human Immunodeficiency Virus Transmission by Blood and Blood Products” for immediate implementation in April 2020 at the beginning of the US COVID-19 epidemic. The title is fancy and technical, but the implications of these recommendations goes far beyond the donation of blood.
A donor deferral for blood donation refers to an individual that is not eligible to donate based on the criteria used to protect the health and safety of both the donor and transfusion recipient. Of the twelve donor deferral recommendations, one states, “Defer for 3 months from the most recent sexual contact, a man who has had sex with another man during the past 3 month.” This is a nine-month reduction to the previous guidance of donor deferral for men who have sex with men (MSM) of twelve months or a year.
The FDA made these changes under the pretense that reform was necessary due to the current state of the medical supply chain. Namely, the novel COVID-19 pandemic placed strain on the healthcare system and general blood supply. If you read the background they provide in the recommendations, you might agree. However, there is much room to believe that the FDA’s donor deferral policy for MSM continues to stigmatize the LGBTQ+ community and HIV.
In their eligibility for donor testing presentation, the FDA clearly outlines a long list of viruses that are tested before the donated blood is actually used, including HIV. They go in-depth to provide options for HIV screening, including the trade names of tests and the manufacturers. There are current evidence-based procedures for blood screening to prevent inactivation for transfusion-transmitted infections, including HIV, HTLV, and Hepatitis viruses, and processes such as heat inactivation for plasma derived-products, including Factor VIII for hemophiliacs. In terms of HIV, blood banks or donation centers can test samples for HIV infection using algorithms based on the prevalence of HIV in the surrounding population and behavioral screening. Simply put, the FDA has standards for maintaining a healthy blood supply without a need for large scale deferral.
With the recent change in donor deferral and the FDA’s continuing concern about HIV in the blood supply, the new ADVANCE study, which is now recruiting participants, is looking into if there should be a change of eligibility criteria for MSM. The Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study appears to be an up and coming progressive push by the FDA to catch up with the times. The FDA stated that “the ADVANCE Study is groundbreaking” as few other studies have looked at the same question, although advocates have been agitating for decades for a fairer process.. For context, the HIV/AIDS epidemic in the United States was first detected in 1981, where 40 years later, this study is the groundbreaking work that could put everything “behind us” in that men who have sex with men (MSM) would not be targeted for specific screening procedures or deferred when donating blood.
As a slow US government response and a lack of funding framed the HIV/AIDS epidemic in the early years, it was not until 1985 when a reliable HIV test was approved. Shortly after, the FDA issued a new policy to “indefinitely defer male donors who have had sex with another male, even one time”. This policy lasted from September 1985 to December 2015. In 2015, the FDA lifted this issuance to a remarkable reduction in time from indefinitely to only a year. The new policy established that men who have sex men could donate blood products only after 12 months from their last sexual encounter. To be more specific, the type of sex is limited to men who have sex with men, which is almost exclusively anal sex. This did not include heterosexual sex. One might further wonder for those who engage in sex with more than one gender, male or female, how this policy makes logical sense. For reference, the FDA does not have a policy for heterosexual contact when it relates to blood product donation.
Those in the LGBTQ+ community have long questioned this discriminatory blood policy by the FDA. The Human Rights Campaign addressed both policy changes, citing the request by the FDA to have abstinence be the moral objective of blood donation as “unacceptable.” How does a change in sexual behavior make it possible to donate blood? It simply doesn’t.
HIV is a sexually transmitted infection. HIV is not exclusively spread within the MSM community, nor is it the only STI spread as a blood-borne/sexual fluid pathogen. The FDA allows for people to donate blood after syphilis and gonorrhea, both STIs like HIV, have been treated. This focus on the treatment itself frames the infection (syphilis or gonorrhea) as the problem, not the act of having sex itself Policies around blood donation for syphilis and gonorrhea discuss deferral to after when one is treated, which is distinct from engaging in the activity that spreads said infection. In contrast, men who have sex with men have to wait until after they have engaged in sexual activity, regardless of whether either sexual partner has contracted HIV. This policy frames queer male sexuality, rather than the HIV virus itself, as an inherently unsafe medical threat. By harnessing stigma toward the LGBTQ+ as a tool to uphold oppression, the FDA’s blood donation policy is rooted in a repressive scene that contends with other moral quandaries at which a heterosexual person would not have to bat an eye.
At the very least, the ADVANCE study is a necessary step in changing the national blood donation policy. However, it is not a beacon of innovation related to addressing systemic health disparities and inequities for those in the LGBTQ+ community.
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