The truth is that all donated blood, once collected, undergoes substantial testing to determine whether HIV or other diseases are present. Screening technologies have seen significant improvements over the past few decades, says Dr. John G. Bartlett, an HIV specialist and former chief of Infectious Diseases at Johns Hopkins University. Dr. Bartlett notes that while there remains an opening in the "window" between exposure and when antibodies--the body's response to HIV--are detectable, as infections can bypass detection within the first few days, the lag time between transmission and detection has diminished. Nucleic acid testing (HIV RNA screening), used in conjunction with antibody testing, looks for presence of genetic material of the virus and can usually detect infection after eleven days. These technologies suggest that the blanket lifetime exclusion perpetuates a thirty-year-old bias, one that medical advancements have taken important strides to eliminate.
Dr. Michael Busch, Director of Blood Systems Research Institute (BSRI), suggests that based on current risks of HIV transmission, a move to a one-year deferral for MSMs is "reasonable." Advances in screening technologies have resulted in an "extremely low" risk of HIV passing undetected, according to Dr. Busch, and a deferral period of three to six months should be sufficient to prevent exposure to a high degree of certainty.
As it stands, the possibility of HIV transmission by blood is significantly slim, with an estimated risk of one in 1.5-2 million transfusions. Aside from MSM individuals, the only groups facing permanent deferral are individuals who have received payment for sex, intravenous drug users, and individuals who have tested positive for HIV and other infections. Uneven application of exclusion to at-risk individuals suggests that risk aversion disproportionately impacts MSMs. For example, a non-MSM individual who has had sexual contact with a commercial sex worker or HIV-positive partner is deferred for only twelve months while other groups are not subject to deferral at all.
Dr. Brian Custer, Associate Investigator in Epidemiology and Health Outcomes at BSRI, supports Dr. Busch's stance by calling for parity in the eligibility rules for blood donation. Dr. Custer points out that the current policies are selective in how donations from potentially higher-risk persons are regulated. To this end, he is leading a series of studies that seek to provide the FDA with scientific evidence to inform possible change to the MSM deferral policy.
The first study, supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), is being conducted as part of the second Retrovirus Epidemiology Donor Study (REDS-II). This study includes the American Red Cross, Blood Systems, the New York Blood Center, and OneBlood, which together are responsible for collecting more than 60% of the US blood supply. An analysis of existing data on the proportion of blood donors testing positive for transfusion-transmissible infections including HIV and hepatitis B and C, and associated risk factors for these agents was initiated in 2011. This study will provide baseline estimates of the current risks of transfusion-transmitted viral infections in the US blood supply. Additionally, the study will determine risk behaviors in donors who "passed" the donor screening questionnaire, including those donors who denied any risk factors but were found to test positive for HIV. The study attempts to gauge how misinformation enters the screening interview and undermines the vetting process for donor eligibility. The study does not seek to "point fingers" at those who provided incomplete information during the screening interview; instead, by analyzing the background of those donors, it provides a clearer picture of what the risk factors in blood donors with HIV and other infections are, thus providing the FDA with a "baseline for risks in the blood supply," according to Dr. Custer.
The second key study, developed in collaboration with University of California San Francisco Center for AIDS Prevention Studies, is being conducted as part of the NHBLI Recipient Epidemiology and Donor Evaluation Study (REDS-III), a larger research program aimed at helping improve blood transfusion product safety and availability in the US and internationally. The new study is an assessment of opinions and perspectives on the current MSM blood donation policy. This study seeks to identify behaviors of men who are currently eligible to donate as well as those who are not, as little data exists on the prevalence of risk within those groups. In considering whether to move to a one-year or five-year deferral policy for MSM (another possibility that has been discussed), it is crucial to understand whether attitudes toward compliance would change--whether lifting the stigma of the lifetime ban would encourage individuals to be more honest during the screening process, and whether a new policy would result in a net increase in donors. Dr. Custer emphasizes the importance of compliance with whatever policy the FDA decides upon.
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Additionally, the FDA has indicated a willingness to revisit its policy, as evidenced by a Request for Information (RFI) published online in the spring of 2012. Studies that allow certain MSM to donate could potentially alter the illusion that all MSM individuals constitute a uniform risk to the blood pool -- one that requires that they be excluded for life.
Many countries including the United Kingdom and Brazil have a one-year deferral period, allowing MSMs to donate blood if they have not had intercourse with a new partner within that time. The United States lags behind other countries that have moved away from questions concerning sexual orientation or MSM contact during the donor screening process. Dr. Busch explains that South Africa and Italy base eligibility on the number of sexual partners in the period before donation. According to Dr. Custer, the Australian equivalent of the FDA is contemplating reducing the one-year deferral criterion for MSM individuals to six months due to technological advancements that have narrowed "the window" of detection.