What Standards Should Apply to Blood Donors?

The FDA’s recent announcement that it would withdraw the lifetime ban on blood donations from men who have sex with men (MSM) was framed as a scientific decision. Advocates for the gay community have characterized it as a first step that doesn’t go far enough.  They contend that the newly proposed one-year deferral still stigmatizes gay men. And, they say, as  a practical matter, the proposed deferral for one year from the last incidence of sexual contact, in effect, requires celibacy, and will operate as a lifetime ban.

The AABB (formerly the American Association of Blood Banks), the American Red Cross, and America’s Blood Centers first issued a joint statement  in support of lifting the lifetime ban in 2006, stating “the current lifetime deferral for men who have had sex with other men is medically and scientifically unwarranted.” They noted that all other individuals who had engaged in behavior putting them at risk of developing AIDS were deferred for 12 months. They also said that the stigmatization of the lifetime ban on donations from MSM not only was unfair and discriminatory, but also had led to the cancellation of blood drives and increased the risk that potential donors would provide inaccurate information to collectors. They supported a 12-month deferral on the ground that it was similar to other behavior-based deferrals. Notably, the AABB has advocated for an end to the lifetime deferral since 1997.

The Science Behind the Announcement

The lifetime deferral was instituted in 1983, when the possibility of contracting AIDS through blood transfusions was first recognized. Since then, valid, reliable tests for the presence of HIV have been developed and are commonly used. In fact, donations are tested for HIV via two different methods, which are capable of detecting HIV  as early as ten days following exposure. The risk of “false negative” test results has been reduced nearly to zero. In 2013, the American Medical Association adopted a policy opposing the lifetime deferral and “support[ing] the use of rational, scientifically based blood and tissue donation deferral periods that are fairly and consistently applied to donors according to their level of risk.”

Overinclusiveness and Underinclusiveness of the Standard

The 12-month deferral would continue to exclude many men who present no risk of transmission of HIV because they are married or in legally unrecognized monogamous relationships. At the same time, women who have had many sexual partners are at increased risk for HIV, but they are not deferred from donation unless they are prostitutes. Promiscuity, or having sex with many men, increases the risk of AIDS, but the approved questionnaire does not include questions about the number of sexual partners the donor has had.

 

Other Deferrals

The need to protect the safety of the blood supply has prompted the FDA to impose requirements that defer donations from individuals whose medical condition might be transmitted to the recipient of their blood.  The FDA regulations require testing of donated blood for bacterial infections, HIV, hepatitis B, hepatitis C, syphilis, HIV, and other viruses.  Donations with positive reactions cannot be used, and the donor must be notified. Individuals who have had cancer or leukemia are deferred indefinitely, as are individuals who have had babesiosis.

The required donor questionnaire is designed to exclude potential donors who are have had or are at risk for these and other conditions, notably malaria,  Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD). Thus, donors who have recently traveled to countries with a high incidence of malaria are deferred for a period of time. The standards apply lifetime deferrals to individuals who have:

  • spent a total of three months in the United Kingdom between 1980 and 1996,
  •  spent five years or more in Europe since 1980;
  • been members of the U.S. military, civilian employees of the military, or their dependents and who spent a total of six months or more in specified countries between 1980 and 1990 or 1996, depending on the country.

All of these individuals are deferred because they are at risk for CJD or vCJD from eating beef there. Lifetime deferrals also are applied to individuals who have received clotting factor or dura mater transplants. None of these circumstances carry any form of blame or stigmatization, however.

Individualized assessments of risk could solve the problem of overinclusiveness and underinclusiveness.  A simple “Have you had more than one sexual partner in the last 12 months?” would come closer to identifying donors who might transmit HIV than asking whether they or any of their partners have had sex with a man since 1977.