To the United States Food and Drug Administration Blood Products Advisory Committee,
We -- the undersigned infectious disease and HIV specialists, public health professionals, clinicians, healthcare administrators, trainees and researchers -- recommend an immediate reevaluation of the FDA’s 2018 “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” and an overturning of the scientifically outdated ban against MSM blood donors.
As you well know, we are on the precipice of a critical nationwide shortage of blood products. On March 18, 2020, Surgeon General Jerome Adams pleaded with the American public for blood donations in the wake of an unprecedented number of blood drive cancellations due to the COVID-19 pandemic, resulting in an estimated 86,000 blood donations according to the American Red Cross. This severe shortage could be alleviated if antiquated restrictions lacking scientific data were responsibly lifted. According to a 2014 study by the Williams Institute at UCLA School of Law, eliminating the MSM ban would result in an estimated 360,600 MSM donors being able to donate an additional 615,300 pints of blood per year. Moreover, lifting the MSM ban would increase the number of convalescent plasma donors, a promising treatment for COVID-19.
We are collectively obligated to immediately create policies and promote public health interventions that effectively address the many downstream crises created by the COVID-19 pandemic.
Since the 1985 blood donation ban against MSM, the science of HIV testing -- particularly the use of pooled nucleic acid testing -- has revolutionized our capacity to identify individuals with HIV attempting to donate blood. HIV nucleic acid testing is nearly 100% sensitive and narrows the window period to approximately 10 days from the time of infection. Banning men from blood donation for at least a year since their most recent sexual encounter with a man is unscientific and based on outdated antibody-based HIV testing algorithms. Fortunately, we can reliably test for HIV using antigen-based assays and maintain the safety of the U.S. blood supply.
While the FDA’s recent decision to shorten the prohibition window to 3 months is a step in the right direction, it does not go far enough in reversing the unscientific ban.
A broad ban against MSM blood donors does not take into account the actual risk behavior in question that could jeopardize blood supply safety -- very recent condomless anal or vaginal intercourse with a partner with HIV viremia -- engaged by those regardless of sex, gender, and/or sexual orientation. Mexico, Russia, as well as several countries in Europe, Central America, South America, and Asia have no MSM ban on blood donation. Many countries, such as Italy and South Africa, have adopted a more rational, evidence-based, and effective risk-based assessment instead of blanket bans which only serve to stigmatize a group of potential donors and limit the pool of donors at this critical juncture in public health. A 2013 study found that after eliminating the MSM blood donation ban in Italy, there was no increase in the proportion of donors found to have HIV who were MSM versus non-MSM. Policies and protocols which focus on targeted screening for specific high-risk behaviors, regardless of sexual orientation, are a much more scientifically rigorous and non-discriminatory approach to maintaining a safe blood supply. In fact, MSM in monogamous relationships, those on Pre-exposure Prophylaxis, and those who consistently use condoms have a particularly low risk of HIV acquisition.
While changing policy and implementing such changes in the field are logistically challenging, the COVID-19 pandemic is asking us to step up and revise regulations that no longer serve the greater good. We are not advocating for relaxing standards that would compromise the safety of our blood supply. Instead, we advocate for scientifically-driven standards that uphold the utmost safety of the blood supply and simultaneously promote equity and reverse historical discrimination in blood donation.
As such, we recommend an immediate reevaluation of the FDA’s 2018 “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” and an overturning of the scientifically outdated ban against MSM blood donors.
With respect,
Deborah Cohan, MD, MPH and Monica Hahn, MD, MPH, University of California San Francisco, HIVEonline.org
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