The federal government has one study in a planning stage and three studies under way that could eventually provide evidence to end the ban on blood donations from all gay men, a federal official said Wednesday.
The key question is, “Can blood safety be maintained or improved under a revised blood-donation screening criteria that would permit donations by lower-risk MSM [men who have sex with men] donors?” Health and Human Services official James Berger told a meeting of the Blood Products Advisory Committee of the Food and Drug Administration.
HHS “is committed to continuous improvement in the safety of the nation’s blood supply,” said Mr. Berger, the acting director of the HHS Advisory Committee on Blood Safety and Availability.
Once research is completed, he said, “There will be a transparent and evidence-based evaluation of MSM donation policies.”
Although Mr. Berger did not offer a time line, activists believe it will be at least two years before there will be enough evidence to support a policy change.
Currently, men who have had sex with men even once since 1977 are indefinitely deferred from donating blood because of the high prevalence of HIV/AIDS and Hepatitis B in such populations. The ban does not cover lesbians.
The ban is now being questioned because of dramatic improvements in testing blood and because, gay groups say, such a policy is “unduly stigmatizing” of MSM.
Gay-rights groups have been calling for a new blood-donation policy for MSM, and the fourth HHS study, now in the planning stages, “really has the potential to be a game changer,” said Nathan Schaefer, director of public policy at the Gay Men’s Health Crisis.
Such a study could establish criteria so “a low-risk subset of gay and bisexual men” could become eligible to give blood, Mr. Schaefer said.
Blood-donor policies on MSM differ widely, with countries often permitting MSM to donate if they have not had gay sex within a certain time frame.
The Gay Men’s Health Crisis does not support such abstinence-based policies because they exclude gay men who are faithful to their partners, Mr. Schaefer said. A better policy could be like that of Spain or Italy, in which all potential donors are asked how many sex partners they have had in the past six months.
Anyone, gay or straight, who says they have had only one partner can donate blood, while others are deferred for a period of time. That would ensure that “high-risk heterosexuals” are deferred too, Mr. Schaefer said.
Groups representing blood and plasma users say that their focus must be on safe, affordable and obtainable blood products, and any changes in blood-donor policy, he said, “Must err on the side of caution.”
The MSM policy “is an important issue that needs consideration” and the Hemophilia Federation of American looks forward “to a dialogue focused on safety and science,” Kimberly Haugstad, executive director of the group, said after Mr. Berger’s presentation.
The National Hemophilia Foundation is “encouraged” by the efforts to get fresh research to evaluate changes to the current MSM policy, said chief executive Val Bias.
The foundation will “continue to work with all interested parties” to make sure that revisions “put safety first and are made on the basis of scientific evidence,” he added.