A federal advisory committee has recommended that the US Food and Drug Administration’s lifetime ban on blood donations from men who have had sex with men (MSM) should remain unchanged.
The US Department of Health and Human Services Advisory Committee on Blood Safety and Availability (ACBSA) met June 10–11, 2010, in Rockville, Maryland, to determine whether to revise the indefinite blood donation deferral, which applies to men who have had sex with another man—even one time—since 1977.
After examining the scientific knowledge, societal factors and economic implications, the committee determined that the available data are inadequate to change the policy. The group voted 9–6 to uphold the ban and recommended more research be done to enable the committee to make a more informed decision in the future.
[Steps for Living: Blood Safety and Universal Data Collection]
Examining Scientific Data
The blood deferral rule was instituted as a result of the HIV/AIDS crisis of the 1980s, when the blood supply became contaminated and many people with hemophilia contracted the disease through clotting factor products pooled from donors. Based on the disproportionately high rate of infection among MSM and the epidemiological information available at the time, it was determined that the best method to protect the blood supply was to remove this group from the donor pool. Following a recent report by the advocacy and service organization Gay Men’s Health Crisis (GMHC), some members of Congress sent letters to the ACBSA requesting that the policy be revised.
The main question is whether there is sufficient scientific knowledge to change the policy and maintain the safety of the blood supply. During the ACBSA meeting, epidemiologists, infectious-disease specialists and others noted that while the HIV/AIDS rate has diminished among MSM from what it once was, there is still a considerably higher rate of infection in this group than in the general population. Further, the HIV rate is now rising among MSM while falling in heterosexuals and intravenous drug users. More than half (53%, or 28,000 cases) of all new HIV infections each year are in MSM, according to the Centers for Disease Control and Prevention. The rate of new HIV infections in MSM is 44 times the rate of new infections in other men. Experts noted that even though testing and screening procedures have improved since the policy was put in place, risk can never be fully eliminated.
The American Plasma Users Coalition (A-PLUS), of which the National Hemophilia Foundation (NHF) is a member, testified that although the MSM infection rate has declined since the crisis in the 1980s, it is not clear how ending the lifetime deferral would affect the overall risk of infection to consumers. A-PLUS is a group of patient organizations whose members depend on plasma protein therapies. Other members include the Hemophilia Federation of America and the Committee of Ten Thousand (COTT). Mark Skinner, president of the World Federation of Hemophilia, spoke on behalf of A-PLUS. Corey Dubin, president of COTT, also presented testimony.
A-PLUS testified that any change in the deferral policy should be based on science, be supported by evidence and adhere to the precautionary principle. A-PLUS provided research recommendations so that if the ACBSA decides to change the policy in the future, its decision will be based on relevant data.
GMHC argued a lifetime deferral on MSM was scientifically unsound, considering that people who engage in other risky behaviors are permitted to donate. The group contended that the deferral policy should be based on the behavior of the individual, not statistics of a group. GMHC asked why homosexual men who have been in long-term, monogamous relationships should be denied the opportunity to give blood, when promiscuous heterosexual men and women are allowed to donate following waiting periods. The deferral system, it argued, is fundamentally flawed and should be improved to account for a wider variety of risks.
The committee acknowledged the deferral policy is suboptimal in permitting some potentially high-risk donations while preventing some potentially low-risk donations. It then unanimously agreed to a series of recommendations on needed research, including modifying the donor questionnaire to better differentiate between low- and high-risk MSM and heterosexual behaviors, and determining the feasibility of donor pre-testing. While a policy change may not be imminent, the blood donor system continues to evolve. NHF will continue to monitor this issue to ensure the safety of the nation’s blood supply.