In September of 1985, the FDA implemented a lifetime ban on blood donations from any man who had ever had sex with another man (MSM). This took place at the start of the HIV/AIDs epidemic, when contracting HIV was considered a death sentence. Untreated, life-expectancy for someone with HIV dropped to a mere 8-10 years, and at the time, no effective treatment regimen had been established.1 When this policy was announced, available testing was limited to antibody screenings with a relatively low sensitivity to detect the virus in donor blood. Banning MSM donors from giving blood was an effort to reduce the risk of contaminating blood products with HIV.
A lot has changed in the world of HIV since the 1980s in terms of disease prognosis, available preventative measures, and sensitivity of blood testing. First of all, health outcomes for patients who contract HIV and begin highly active anti-retroviral therapy (HAART) are vastly improved from the bleak picture painted in the 80’s. The life-expectancy for these patients is only slightly shorter than those without HIV.2 HAART also has important implications for reducing HIV spread. Once a person’s viral load has been reduced to undetectable levels through a HAART regimen, that person has no risk of transmitting HIV to any other person via sexual contact.3 Another development since the initial ban on MSM donations is the advent of pre-exposure prophylaxis (PrEP), which was approved by the FDA in 2012 to be taken by HIV-negative people with potential for future exposure, and reduces the risk of contracting HIV by 99%.4 These developments have led to declining incidence rates. In the 1980’s, the CDC estimated 150,000 new cases per year in the US. This number is now below 35,000 as of 2019.5,6
Pathogen screening for blood donations has also changed dramatically. For any screening test for HIV, there is a window period between the time when a person first becomes infected with the virus and the time that a test will be able to accurately identify the infection. In 1985, the first blood test for HIV screening had only just been approved, and it relied on IgG antibody detection. This created a lengthy window period of nearly three months. Since then, new methods of virus detection have developed; current standard practices involve nucleic acid testing which have lowered the window period of detection down to just two weeks.7
In light of these developments, the FDA has updated the 1985 restriction. In December of 2015, the lifetime ban was replaced with a policy allowing MSM to donate so long as they had abstained from sex with another man for at least one year. Following this change, there was no increase in HIV spread through blood transfusions.8 In April of 2020, as the COVID-19 pandemic increased the need for blood donation, the FDA reduced the policy even further, down to its current state – MSM must wait three months since their last sexual encounter to donate blood.8
While these changes represent positive steps, the timeline with which these changes took place was far too slow. The BloodDROPS study, which demonstrated that HIV prevalence among MSM blood donors was not 11-12% as estimated, but rather a mere 0.25% was the key research behind the decision to implement the initial 2015 policy change.8 This study was done in 1998. That’s 17 years of ignoring available data. The second reduction of 2020 was made in response to the COVID epidemic. The FDA, as stated in the revision, knew the modification of the ban would significantly increase blood donations and expected no increase in rates of HIV transmission through blood products. Although the severity of blood shortages may be higher in light of the COVID public health crisis, blood shortages are not a new phenomena in the US. It should not have taken a pandemic to motivate the removal of a discriminatory policy, especially when the removal has a direct positive impact on public health. This data existed before COVID, and it should have been implemented before COVID.
On top of being slow to implement, the current state of MSM donation policies still fails to reflect good science. As discussed earlier, screening efficacy for HIV infection has drastically improved. Current nucleic acid screening has a window period of detection of about two weeks. That’s ten weeks shorter than the current abstinence requirement for MSM. Asking donors to abstain from sex for three months when a couple weeks would do is both unnecessary and acts as a deterrent for donation.
Even beyond screening improvements, any policy that places a donor restriction on the basis of sexuality alone without taking into account any other factors seems deeply problematic. Imagine a gay man in a monogamous relationship with another man. Imagine they have both been tested and received negative results for HIV. Imagine that they use condoms or PrEP or both. These men are not eligible to donate blood on the grounds of being an HIV risk. Now imagine a woman who has multiple male partners. She does not use condoms. She does not know her HIV status. She does not know her partners’ HIV statuses. This woman can donate blood, as she is not considered an HIV risk. While more common in MSM, heterosexual people represent 23% of new HIV diagnoses6. Any policy utilizing sexuality alone as a blanket marker of risk without factoring in the number of partners, condom use, PrEP use, knowledge of their HIV status or that of their sexual partners fails as a policy intended to capture HIV risk.
Perhaps the most blatant piece of evidence demonstrating the failure of current FDA policy to reflect good science arises from guidance on transgender men who have sex with men. The 2020 revision recommends that gender be self-identified and self-reported.8 The FDA’s acknowledgement that gender identity is distinct from any factor of mere biology is an excellent step towards the inclusion and respect of transgender people, but in the case of blood donations, a person’s gender identity should not play any part in screening. Transgender women do have significantly higher rates of HIV infection, but this is not so true of transgender men.6 Nevertheless, transgender women who have sex with men are not excluded under FDA guidelines, but transgender men who have sex with men are. Take this one last example to illustrate the absurdity of this guidance. Imagine a heterosexual-appearing couple in a committed, monogamous relationship. Both partners know that their HIV status is negative. They can both donate blood. Now, years later, in the same monogamous relationship, one partner comes out as a transgender man. Both partners are now considered men who have sex with men and cannot donate blood (without abstaining from sex for three months), despite no other changes to their relationship. Barring transgender MSM from donating blood has absolutley no grounding in science. It is clear evidence that current policies do not reflect real concerns of HIV risk, but rather, are indicative of lingering stigma surrounding men who have sex with men.
The medical field should be committed to ending all forms of discrimination and should actively oppose any policy that restricts minority groups without legitimate grounds, especially when those restrictions negatively impact public health. In the case of MSM blood donation bans, we have a policy in place that is not based in modern science and technology. The initial ban implemented in the 1980’s may have been warranted at the time given the lack of sensitive testing, limited knowledge of the disease, and the rampant mortality associated before the advent of HAART, but in light of current developments in testing sensitivity, reductions in HIV prevalence, and widespread use of PrEP, even the new and improved updates of 2020 are in desperate need of change.
Works Cited
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2. Marcus JL, Leyden WA, Alexeeff SE, et al. Comparison of Overall and Comorbidity-Free Life Expectancy Between Insured Adults With and Without HIV Infection, 2000-2016. JAMA Netw Open. 2020;3(6):e207954. doi:10.1001/jamanetworkopen.2020.7954
3. Eisinger RW, Dieffenbach CW, Fauci AS. HIV Viral Load and Transmissibility of HIV Infection: Undetectable Equals Untransmittable. JAMA. 2019;321(5):451-452. doi:10.1001/jama.2018.21167
4. PrEP Effectiveness | PrEP | HIV Basics | HIV/AIDS | CDC. Published May 13, 2021. Accessed October 17, 2021. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html
5. HIV and AIDS --- United States, 1981--2000. Accessed October 20, 2021. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5021a2.htm#tab1
6. June 02 CSH gov D last updated:, 2021. U.S. Statistics. HIV.gov. Published June 2, 2021. Accessed October 20, 2021. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
7. Alexander TS. Human Immunodeficiency Virus Diagnostic Testing: 30 Years of Evolution. Clinical and Vaccine Immunology. 23(4):249-253. doi:10.1128/CVI.00053-16
8. Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry. :21.