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  • Thousands were infected with HIV through blood transfusion before the causative virus was identified and the first screening tests were approved in 1985. The FDA subsequently decided to indefinitely defer male donors who have had sex with another male since 1977, even one time, due to high rates of HIV infection in that population. (See the graphics below.)

  • The FDA defines a MSM as a man who has sex with other men, where the word "man" wrongly refers to sex rather than gender.

  • The deferral affects a wide range of persons (e.g. bisexual individuals, pansexual individuals, transgender women) by restricting donations on the basis of sexual behavior rather than self-identity.

  • The FDA defines fellatio (i.e. oral intercourse on a penis) as a sexual act despite there never being a documented case of oral HIV transmission. The FDA has encountered difficulty in estimating the likelihood of HIV transmission through this route given that other forms of sex usually accompany oral intercourse, but experts generally believe that HIV transmission through fellatio would have to occur through sexual fluids entering an open wound, an unlikely prospect.

  • Perhaps the strongest indicator that discriminatory bias contributed to the late annulment of the deferral comes from noticing that women who had sex with an MSM were only deferred from donating for a year following the sex despite being at no greater risk.

  • The use of donor educational material, specific deferral questions, advances in HIV donor testing (e.g. HIV antibody assays and nucleic acid tests), and lowering infection rates among MSMs drastically reduced the risk of HIV transmission from blood transfusion.

  • The risk lowered from about 1 in 2500 infected units to a current estimate of about 1 in 1.47 million transfusions. In May of 2015, the FDA then published “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”. This document argued for a 1-year MSM deferral period and sought public feedback. The FDA did not change its policy accordingly until December of 2015. The FDA will monitor the blood supply to ensure that the new deferral does not jeopardize its integrity.

  • The rate of MSM non-compliance under the indefinite deferral policy increased from 0.6% in 1993 to 1.2% in 1998 and to 2.6% in 2013. The growing sentiment among MSMs that the policy unfairly discriminates against them likely accounted for this increase; a web-based community survey revealed that approximately 90% of MSM think the MSM blood donation deferral ought to be annulled, and 59% of MSM reported that they would comply with a change to a one-year deferral. As a result, the FDA considered alternatives.

  • In 2010, a similar change regarding MSM was made in Australia, where the epidemiology of HIV resembles that of the United States, with no observable adverse effects documented to date.

  • The majority of information on this website is paraphrased from the revised recommendations.

A HISTORY OF MSM DEFERRAL

1977

AIDS Outbreak

1983

Lifetime MSM Deferral Enacted

1985

First Screening

Tool Developed

DeC 2015

FDA Enacts 1-year MSM Deferral

July 2015

FDA Publishes Revised Recommendations

2010

Australia Switches to 1-year MSM Deferral*

Where to now?
You decide.

SUPPORTING DATA

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