Mark Skinner is a Washington-based attorney and president of the World Federation of Hemophilia.
The Food and Drug Administration policy that men who have had sex with another man, even once, since 1977 are deferred indefinitely from donating blood has generated an important scientific and public health debate.
The Department of Health and Human Services' blood advisory committee has concluded that current donor deferral policies are suboptimal. But the committee also correctly noted that the available scientific data are inadequate to support a change to a specific alternative policy at this time and instead recommended a critical review to validate alternative policies.
According to the Centers for Disease Control and Prevention, 4.9 million Americans require a transfusion of blood or blood products every day. Those living with chronic conditions such as thalassemia, sickle cell disease, hemophilia, or other, rarer disorders depend upon blood and the essential medications derived from it for daily living. Blood safety is fundamental to their well-being, as well as for all Americans who might need a transfusion following an accident, surgery, or for another medical need. A policy change cannot be justified based on the small estimated increase in donations without considering relevant scientific issues.
Recent CDC data indicate that while U.S. HIV infection rates are falling in heterosexuals and intravenous drug users, they are rising among men who have sex with other men and are 44 times that of other men. Additionally, other pathogens that might also be transmitted through high-risk sexual behavior are not fully understood.
The transmission of HIV through the blood supply in the 1980s led to a 1995 Institute of Medicine report that examined the government's response to the crisis. The institute recommended that precautionary measures be put in place when facing future threats. It remains imperative to heed this common-sense principle.
Blood donor deferral criteria must put recipient safety first. Donor deferrals are not judgments about individual donors but rather are based on scientific and epidemiological evidence about large groups of people. By their very nature, they are discriminatory; however, they are justifiable when providing increased protection to public health. They are established to reduce the risk of both known and unknown disease-causing pathogens being passed to blood recipients. Current screening, testing, and pathogen reduction technologies are not sufficient to eliminate the risk of an as yet unknown disease being transmitted. Thus, it continues to be necessary to decline some donations based on established epidemiological evidence.
There are several alternative deferral polices that merit research. These include examining whether a pre-screening blood test and/or a behavioral-based donor risk assessment questionnaire could be implemented targeting high-risk behaviors among all sexual orientations rather than utilizing broad population-based deferrals. Such research could lead to a policy revision that reduces discrimination and maintains or enhances the overall safety of blood and blood products. But in light of the lack of scientific evidence, it is prudent for the FDA to proceed cautiously and first establish a scientific basis, which will allow confidence in any change.
While many perceive a disconnect between leading gay rights and end-user patient organizations, these groups have more in common than recent discourse reflects. Both have been disproportionately impacted by the HIV epidemic and for most of the past quarter-century have worked toward shared goals including preventing the virus's spread. Both share a strong commitment to a safe national blood supply. Chronic users of blood empathize with those advocating for a policy change. Without the altruism of blood donors, many would not be living today.
Blood donor policies must ensure safety above all and should be adapted so that donor altruism is respected in the least prejudicial way consistent with the reality that the end-user bears 100 percent of the risk. The critical review called for by the advisory committee is the important first step.