Eleven organizations that represent users of blood plasma and related products will urge a federal panel on Tuesday not to change the donor policy for gay and bisexual men unless a “robust” blood-monitoring system is also put in place.
Scientifically, there is now a basis to consider changing the lifetime ban on blood donations from men who have sex with men (MSM), the American Plasma Users Coalition (A-PLUS) said in a statement filed with the Food and Drug Administration Blood Products Advisory Committee (BPAC).
However, a “robust, comprehensive hemovigilance program” must be implemented as part of any donor policy change to track changes in blood safety risks and permit “rapid corrective action” if needed, said the groups, which represent some 125,000 Americans who depend on blood products to live healthy lives.
The FDA BPAC is scheduled Tuesday to review research aimed at facilitating a change in the “suboptimal” MSM policy — which offends many gay rights groups and their allies — without heightening risks of adding contaminated blood to the blood supply.
One presentation will show that between 2011 and 2012, 14 units of donated blood tested positive for HIV, for a rate of 3 per 100,000. Most of those units came from young men.
These and other findings were presented Nov. 13 to the Department of Health and Human Services’ Advisory Committee on Blood and Tissue Safety and Availability; that panel voted 16-2 to recommend the MSM policy be changed to a one-year deferral after last sexual contact.
Currently, men who have had sex with a man “even once” since 1977 are not permitted to donate blood.
The one-year deferral for MSM was proposed in part because it is practiced elsewhere — such as Australia — and matches the deferral policy for other sexual high-risk groups, such as people who have had sex with someone who is HIV-positive, a prostitute, a person who has injected drugs not prescribed by a doctor and women who have had sex with a gay or bisexual man. Notably, people who themselves injected illegal drugs or sold their bodies for money or drugs are permanently deferred as blood donors.
Major blood banks signaled their support of the one-year deferral for MSM after the Nov. 13 vote by the HHS panel.
But supporters of gay rights were not happy with the one-year deferral and its “outrageous celibacy requirement.”
A time-based deferral based solely on gay and bisexual sex “is still discriminatory and fails to exclude donors based on actual risk factors,” said Rep. Mike Quigley, Illinois Democrat, who leads a bipartisan, bicameral congressional group on the MSM policy. Mr. Quigley, who is submitting testimony to the FDA BPAC, urged it to “recommend a deferral policy based on behavioral risks commensurate with the rest of the population.”
Lawrence LaMotte, vice president of public policy for the Immune Deficiency Foundation, which is part of A-PLUS, said that a national, fully integrated and transparent monitoring system is “the key to everything here.”
Any change to the MSM policy “has to be contingent” on that monitoring system, as it can track actual changes that result from a MSM policy change, plus respond to emerging infectious threats to the blood supply, he said. “No one ever expected AIDS to happen,” said Mr. LaMotte, “and you don’t know what’s coming around the corner.”