In 1983, during the beginning of the AIDS epidemic, the FDA introduced a lifetime exclusion of sexually active men who have sex with men (MSM) as prospective blood donors. At this time, the ascertainment of HIV status was not possible and not a lot was known about the disease. More than three decades later, we now know how the virus is transmitted and the most modern screening tools can detect HIV in less than 2 weeks after transmission. The lifetime ban, however, remains.
On Tuesday, an FDA advisory panel met to discuss whether or not the federal government should reverse its policy banning gay men from donating blood. The Blood Products Advisory Committee — the group of outside advisors to the FDA — said scientific testing of blood has become far more precise and is adequate to ensure that donated blood remains safe. If the FDA were to lift the ban, gay men would be allowed to give blood if they abstained from sexual encounters with men in the past 12 months. At this point the FDA has not indicated when it would make a decision on changing the ban.
The possibility of change comes amid growing calls from medical groups, gay rights activists and lawmakers to abandon the ban as outdated and discriminatory. The American Red Cross, America’s Blood Centers and the American Association of Blood Banks have opposed the ban as “medically and scientifically unwarranted”. In June 2013, the American Medical Association issued a statement calling on the FDA to change the policy, stating that “The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science.”
In a recent article published in the Journal of the American Medical Association (JAMA), Cohen, Feigenbaum and Adashi set out how the MSM ban has been rendered useless. They set out four main points:
Modern nucleic acid diagnostic technology has advanced to a point where HIV can be detected within a 9-11 day window period of the donor becoming infected;
Effectively designed screening tools focused on individual behaviors and risk are now practicable, permitting the detection of safe-sex practices, monogamy, or HIV status;
The current policy is increasingly incompatible with international norms; and
The current policy is both inconsistent and inequitable; while MSMs face a lifetime ban, men who have had sex with commercial sex workers or with HIV-positive women and women who have had sex with HIV-positive men are only deferred for a year.
The US is one of the few countries that still has a lifetime blood donation ban for MSM. Several nations, such as the UK, Australia and Japan have recently limited their deferral periods for sexually active MSMs to a year. South Africa has a 6 months deferral period for anybody who has had sex with a new partner, regardless of gender or sexual orientation. Other countries like Spain and Italy have taken an even less discriminatory approach, assessing risk based on individual behaviors.
In 2001, the Italian Ministry of Health replaced its permanent deferral of MSM donors with an individual risk assessment approach. With this protocol, any prospective donor—regardless of sexual orientation—must complete and extensive questionnaire about their sexual history and then a face-to-face interview with a trained physician. Prospective donors are then sorted into one of three categories:
Low or no risk: eligible to donate.
“Risk” behaviors, such as casual sex with an HIV-positive partner or with one of unknown status: temporary 4-month deferral followed by repeat assessment and testing.
“High risk” behaviors, such as exchanging sex for money, injecting drugs or having repeated sex with one or multiple HIV-positive partners: permanently banned.
A recent study has shown that when comparing the period before (1999) and after (2009–2010) the implementation of the individual risk assessment policy in Italy in 2001, no significant increase in the proportion of men who have sex with men compared to heterosexuals was observed among HIV antibody-positive blood donors, suggesting that the change in donor deferral policy did not lead to a disproportionate increase of HIV-seropositive MSM.
Considering the science and the international evidence, changing the ban to a one-year deferral would still be conservative approach. However, it is a necessary first step. As was stated by Jeffrey Crowley, the program director of the National HIV/AIDS Initiative at the O’Neill Institute, “It is a big change. Most gay men will still be deferred from donating (because we are sexually active), but it won’t be a lifetime ban, [It p]uts our policy more in line with other developed countries.”
An estimated 37% of the US population is eligible to donate blood, but less than 10% of those eligible actually donate each year. The small eligibility pool is due in part to restrictions placed upon potential donors like the MSM ban. A 2010 study by UCLA found that lifting the ban fully could increase the total annual supply of donated blood by between 2 and 4 percent, adding as many as 615,000 pints per year. A shift from the full ban to a 12-month deferral could add about 317,000 pints a year.
Instead of considering the abolition of the permanent deferral, the FDA and policy makers should consider a behavioral approach to screening. It appears that to the FDA, it doesn’t matter whether MSMs are in monogamous relationships and practicing safe sex or if heterosexual donors are practicing much riskier sexual acts. Screening of donors should focus on individual sexual behaviors in order to be more inclusive, equitable, and even safer.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.