Should the FDA Lift the Ban on Blood Donations From MSM?

Regarding MSM specifically, the agency points to the higher prevalence of HIV among MSM.5 They state that of the 44,000 new HIV infections per year in the United States, 2 out of 3 occur in this population. However, Dr Sacks and colleagues note in their paper that, “with near-perfect sensitivity of 4th-generation HIV testing after the window period, prevalence has minimal, if any, effect on the predictive value of a negative test result.” They reason that the risk of HIV in the blood supply primarily stems from the risk of individuals donating within the few weeks following infection, and thus any “policy designed to protect the blood supply from HIV would focus on excluding potential donors — of any sexual orientation — at risk for having acquired HIV in the several weeks before donation.”

They offer an example of the current policy’s flawed logic: A monogamous gay man who has consistently tested negative for HIV for decades — as has his partner — would not be permitted to donate blood, while donations from a heterosexual man who frequently has unprotected sex with women of unknown HIV status would be permitted. 

The FDA remains open to further revision of the policy. In addition to the call for public comment, the agency will also conduct a survey under the Transfusion-Transmissible Infections Monitoring System (TTIMS) program. To collect information on associated risk factors, the survey will include interviews with blood donors who test positive for a TTI, as well as interviews with donors who have negative test results, who will serve as controls.

“The results from the survey will inform the FDA regarding future blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments,” and the findings will also help with the design of related studies, said agency representatives. “Moving forward, the FDA will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.”

In addition, with assistance from the National Heart, Lung, and Blood Institute at the National Institutes of Health, the agency has implemented a blood supply safety monitoring system that will provide further information to potentially inform FDA actions on donor policies.

Dr Sacks and colleagues advocate for a policy that focuses on individual risk assessment in addition to the current protocol of testing every donated blood sample for HIV. “A questionnaire, which currently asks if a man has had sex with a man in the past year, should instead be developed to assess the individual risk of potential donors, regardless of sexual orientation,” she said. “Of course, rigorous empirical evaluation of the outcomes must follow from any new policy changes.”

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References

  1. US Food and Drug Administration. Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products–questions and answers. US Food and Drug Administration website. Updated December 21, 2015. Accessed January 20, 2017.
  2. Berkman RT, Zhou L. Ban the ban: A scientific and cultural analysis of the FDA’s ban on blood donations from men who have sex with menCol Med Rev. 2015;1:2-9. doi: 10.7916/D8HX1BST
  3. De Buck E, Dieltjens T, Compernolle V, Vandekerckhove P. Is having sex with other men a risk factor for transfusion-transmissible infections in male blood donors in western countries? A systematic reviewPLoS One. 2015;10:e0122523. doi: 10.1371/journal.pone.0122523
  4. Sacks CA, Goldstein RH, Walensky RP. Rethinking the ban: the U.S. blood supply and men who have sex with menN Engl J Med. 2017;376:174-177. doi: 10.1056/NEJMms1613425
  5. Epstein J, Ganz PR, Seitz R, et al. A shared regulatory perspective on deferral from blood donation of men who have sex with men (MSM)Vox Sang. 2014; 107:416-419. doi: 10.1111/vox.12166