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FDA affirms ban on blood from men who have sex with men
Blood donation advocacy groups said the ban is not based on science.
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The FDA currently prohibits any man who had sex with another man since 1977 from donating blood, a position that scientific advocacy groups say is discriminatory against homosexuals.
“This is because men who have sex with men are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion,” according to documents provided by the FDA.
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The FDA said the policy is not unique to the United States and is consistent with policies in place in the European Union.
Although the policy has remained unchanged since 1992, experts from the American Association of Blood Banks, America’s Blood Centers and the American Red Cross said it does not reflect the current scientific landscape.
“We now have evidence to show that the vast majority of donors with prevalent infections will be positive by both antibody tests and nucleic acid amplification testing, thus assuring redundancy in laboratory testing,” Steven Kleinman, MD, senior medical advisor of the American Association of Blood Banks, wrote in a press release.
Ronald Sacher, MD, director of the Hoxworth Blood Center at the University of Cincinnati Medical Center and section editor of HemOnc Today’s Transfusion Medicine section, said current screening methods are sufficient.
“The blood supply is the safest it has ever been. The tests that have been implemented have been effective in preventing the transmission of sexually acquired diseases,” Sacher told HemOnc Today.
A discriminatory ban
Under current policy, men or women who have put themselves at risk for sexually transmitted diseases via heterosexual contact since 1977 are deferred from donating for one year. According to the advocacy groups, there is no rationale for a lifetime ban for MSM.
“To many, this differentiation is unfair and discriminatory, resulting in negative attitudes to blood donor eligibility criteria, blood collection facilities and, in some cases, to cancellation of blood drives,” Kleinman wrote in the press release.
The FDA does not consider its policy to be discriminatory. According to the CDC, MSM are the largest group with new HIV infections. They are 15 times more likely to have HIV than the general population and 2,000 times more likely to have HIV than repeat blood donors, according to documents provided by the FDA.
“The FDA’s deferral policy is based on the documented increased risk for certain transfusion-transmissible infections, such as HIV, associated with male-to-male sex and is not based on any judgment concerning the donor’s sexual orientation,” according to documents provided by the FDA.
The advocacy groups acknowledge that the relaxation of deferral criteria might increase the number of presenting donors who have HIV.
“However, this impact has not been measured directly; it has only been modeled using what may be incomplete assumptions. The blood collectors are willing to assist in collecting data regarding the actual impact of changes in the deferral to allow for informed decision-making and for the development of additional, appropriate measures to ameliorate the impact,” Kleinman wrote in the press release.
‘Fuzzy’ science
The FDA has given no indication that it will change its policy in the near future. A spokesman for the FDA, speaking on condition of anonymity, said a recent article in The New York Times, “Drug Agency Reaffirms Ban on Gay Men Giving Blood,” misunderstood the FDA action.
“This ban has been in place for years. All we did was redesign a website to make information on the policy more accessible and user-friendly,” the spokesman said.
Sacher, who declined to say whether he endorsed the ban due to the sensitivity of the issue, said the science surrounding it was “fuzzy.”
“With our current tests, the risk for an HIV infection slipping through is about one in 2 million. This is an emotional and political issue, not a scientific one,” Sacher said.
Documents provided by the FDA confirmed Sacher’s estimate, but the tests still could not detect HIV, “100% of the time. The FDA’s primary responsibility is to enhance blood safety and protect blood recipients. The FDA remains willing to consider new approaches to donor screening and testing, provided these approaches assure that blood recipients are not placed at an increased risk for HIV or other transfusion-transmitted diseases.” – by Jeremy Moore