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FDA’s blood donation policy for MSM spurs debate
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The most recent version of the FDA’s blood donation guidelines, which allow men who have sex with men to donate if their most recent sexual contact occurred at least 1 year ago, was released in December 2015. This version updated earlier guidelines that imposed a lifetime ban on all blood donations from this population.
However, since the updated policy was released, calls for the removal of the 1-year celibacy requirement have prompted the FDA to review its stance on blood donations from MSM. The administration opened a forum for public comment and is seeking feedback on the feasibility of alternative deferral options, such as the use of individual risk assessment, until Nov. 25.
Pleas to rescind the 1-year celibacy requirement grew in the wake of the June 12 Pulse nightclub massacre in Orlando, Florida, in which 49 people were killed and more than 50 were injured in the deadliest mass shooting in United States history.
“The Pulse nightclub shooting struck a deep, resonate chord among gay men — and members of the transgender community — because we were unable to donate blood, one of the most powerful and life-giving responses we could have in that situation,” William McColl, director of health policy for AIDS United, told Infectious Disease News.
Evidence for safety of 1-year deferral policy varies
One request to end the celibacy requirement was issued by more than 130 members of Congress about 2 weeks after the shooting. During a teleconference call with reporters, Rep. Jared Polis, D-Colo., the first openly gay parent in Congress, called on the FDA to “make screening based on behavior and science, not orientation.”
According to Lyndsay Meyer, a press officer at the FDA, the policy is “based on careful consideration of recently completed studies and epidemiologic data.”
“A 12-month deferral has been well-studied and found, among other things, to maintain the safety of the blood supply in Australia, a country with HIV epidemiology and blood screening systems similar to the U.S.,” Meyer told Infectious Disease News. “During the change in Australia from an indefinite blood donor deferral policy for MSM to a 12-month deferral, well-conducted studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These studies, which have been published, document no change in risk to the blood supply with use of the 12-month deferral.”
However, McColl contends that the deferral policy “is not about actual risk.”
“Sexual acts that have some level of risk apply not only to potential gay donors,” he said. “In fact, heterosexual donors may engage in essentially the same sexual activities, or other types of activities, that put them at greater risk [for HIV]. Blanket deferral policies leave out a part of the population that actually should be considered for inclusion and spreads a false misconception that heterosexual sex is safe from HIV exposure.”
In 2001, Italy introduced a new policy regarding blood donations that categorized sexual behavior based on “risk” and “high-risk” designations, ending a permanent deferral of donations from MSM. Blood donors — both heterosexuals and MSM — who report engaging in high-risk behaviors are permanently deferred from donating blood; such behaviors include usual and/or recurrent sex with more than one heterosexual or MSM partner whose sexual behavior is unknown; receiving or exchanging sex for money; injection drug use; and usual/recurrent sex with a partner positive for syphilis and/or HIV, hepatitis B and hepatitis C. Individuals who engage in risk behaviors, which include having a new partner whose sexual behavior is unknown, having ever had one occasional sexual relationship with a person whose sexual behavior is unknown, or having had casual sex with a partner who has HIV and/or HBV and/or HCV, are deferred from donating blood for 4 months from the risk event.
An analysis of this risk assessment system compared data from 1999 — before the permanent deferral was repealed — with data from 2009 and 2010, examining the change in the proportion of HIV antibody-positive heterosexual and MSM donors. Among such donors, “heterosexuals always accounted for at least 40% of all cases,” the researchers wrote.
The proportion of both MSM and heterosexual donors who were HIV antibody-positive increased over time. The rate of HIV antibody-positive MSM per 100,000 men who donated blood was more than twofold higher in 2009 and 2010 than in 1999 (RR = 2.8). The rate of HIV antibody-positive heterosexuals among all donors was 1.5-fold higher in 2009 and 2010 than in 1999 (RR = 1.5). However, these differences were not statistically significant.
“When comparing the period before and after the implementation of the [individual risk assessment] policy, no significant increase in the proportion of MSM compared with heterosexuals was observed among HIV antibody-positive blood donors, suggesting that the change in donor deferral policy has not led to a disproportionate increase of HIV–seropositive MSM,” the researchers wrote.
A ‘less stigmatizing’ approach
The analysis of the Italian policy demonstrates that “being gay does not increase HIV risk once risk factors for HIV acquisition are assessed on an individual basis,” according to Infectious Disease News Editorial Board member Peter Chin-Hong, MD, MAS, professor of medicine, Academy-Endowed Chair for Innovation in Teaching, director of the Pathways to Discovery in Clinical and Translational Research program, and director of the transplant and immunocompromised host infectious disease program at the University of California, San Francisco.
“MSM who are in monogamous relationships and use pre-exposure prophylaxis consistently and/or use condoms are certainly no more at risk for HIV acquisition than heterosexual individuals who have multiple unprotected sex partners,” Chin-Hong told Infectious Disease News.
Currently, the FDA is assisting organizations to implement the 1-year deferral policy. A safety monitoring system for the nation’s blood supply has also been implemented with assistance from the NIH’s National Heart, Lung, and Blood Institute.
This system “will provide critical information to help inform future actions that the FDA may take on blood donor policies,” Meyer said.
Chin-Hong believes the U.S. should “absolutely” consider implementing a risk-based assessment for blood donations.
“A policy based on individual risk will mean, simply, that there will be more blood available to provide to our patients when in need, particularly in a disaster setting,” he said. “One UCLA School of Law study suggested that lifting the ban could increase the total annual blood supply by 2% to 4%, adding as much as 600,000 additional pints of year to the U.S. blood supply. The second main impact is arguably more important: We will have a policy that will be more inclusive and less stigmatizing than our current approach.” – by Julia Ernst, MS
- References:
- FDA. Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products — Guidance for industry. 2015. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf. Accessed October 6, 2016.
- Seed CR, et al. Transfusion. 2010;doi:10.1111/j.1537-2995.2010.02793.x.
- Suligoi B, et al. Blood Transfus. 2013;doi:10.2450/2013.0162-12.
- Williams Institute. Update: Effects of lifting blood donation bans on men who have sex with men. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Blood-Ban-update-Jan-2015.pdf. Accessed October 19, 2016.
Disclosures: Chin-Hong and McColl report no relevant financial disclosures. Meyer is a press officer for the FDA. Polis is a member of Congress.
Perspective
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Paul A. Volberding, MD
In the early epidemic, HIV tests were either not yet developed or were not fully sensitive, and banning MSM from donating blood made some sense. But, since then, the HIV blood tests have become extremely accurate — essentially 100% sensitive and specific. We can now detect HIV very soon after infection, in as early as a few days in some cases, and certainly in a few weeks. Testing should really be the issue in accepting blood donations rather than the donors recollection of his last sexual contact. Moving from a lifelong ban to a year is a move in the right direction, but a year is far too long. Bans are inherently discriminating and we should apply the highest standards of blood testing as a better way to ensure the safety of this crucial commodity.
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