FDA May Ease Blood Donation Ban on Men Who Have Sex With Men

Miriam E. Tucker

December 03, 2014

An advisory committee to the US Food and Drug Administration (FDA) expressed support for a relaxation of current policy regarding blood donation among men who have sex with men (MSM) but coupled that support with a strong endorsement for nationwide strengthening of surveillance for transfusion-transmissible infections.

If adopted by the FDA and signed by the US Secretary for Health and Human Services (HHS), the policy would change from a lifetime donation ban to a 1-year deferral for any male who answers affirmatively the question, "Have you had sexual contact with another male, even once?"

At a meeting on December 2, 2014, the FDA's Blood Products Advisory Committee was asked to weigh in on that recommendation, made 2 weeks earlier by the Advisory Committee for Blood and Tissue Safety and Availability of the HHS. The FDA panel also endorsed the HHS committee's recommendations for improvements in surveillance, evaluation, and revision of donor education materials, as well as better sensitivity and specificity of the selection criteria to identify at-risk donors.

The FDA specifically asked the panel, assuming that the 1-year deferral is adopted, whether serologic tests for recency of HIV infection in HIV antibody-positive donors are sufficiently accurate to be useful for blood safety monitoring. Panelists gave mixed answers but generally agreed that although imperfect, such tests could be used among other tools for surveillance in general, and specifically to measure the effect of changing the policy.

The current system of questionnaire screening plus blood testing has become so effective in the last few years that HIV transmission via blood transfusion is now extremely rare. Current nucleic acid testing has reduced the seronegative "window" of potential infectivity to approximately 10 days, Alan Williams, PhD, from the FDA's Center for Biologics Evaluation & Research, told the panel.

The most recent posttransfusion HIV case was in 2008, and there were no cases in the 5 years before then. The current estimate is about one posttransfusion case of HIV exposure per 1.86 million donations, times 20.9 million transfused components (in 2011), or about 11 HIV exposures and 10 infections per year, Dr Williams said.

Committee chair Brooks Jackson, MD, dean of the medical school and vice president for health sciences of the University of Minnesota, Minneapolis, told Medscape Medical News, "There should definitely be a deferral, because the tests are not perfect. But I would say that the tests have gotten so good...and maybe [the new policy] will improve compliance. So I think the increased risk is probably pretty low by changing the policy as long as we can monitor it well."

What Is the Best Policy Focus?

The reason for the proposed policy change is part science and part societal (but is not about the blood supply, which is currently plentiful). During public comment, several members of the lesbian-gay-bisexual-transgender community called the current policy discriminatory and not supported by current evidence.

Jesse Joad, MD, president-elect of the Gay and Lesbian Medical Association (GLMA), asked the panel to consider a policy addressing specific at-risk behaviors regardless of sexual orientation or sex, rather than a time-based deferral. "GLMA has long been concerned about the stigmatizing effects of the blood donation deferral policy. What is the scientific rationale behind preventing an HIV-negative man who is in a long-time monogamous relationship with an HIV-negative partner from donating blood?"

However, other speakers said that recipient safety should be the policy focus. Panel member Susan F. Leitman, MD, agreed. "In 31 years of blood banking, it's been pounded into our heads that we are to mitigate risk for recipients.... This is the first time that a step away from that mitigating risk has been taken, and I don't think any of the data I've heard calms me in terms of not increasing risk to the transfusion recipient."

Indeed, Dr Williams summarized data from several studies showing that approximately 1% of male donors give blood in the United States within 1 year of having had male-male sex, despite the donor history questionnaire. In all, MSM represent about 4% to 7% of the male population but accounted for 78% of the new HIV infections among males in 2010.

In community surveys, 59% of MSM said that they would comply with a 1-year deferral. However, between 30% and 50% said they were likely to remain noncompliant despite a policy change, citing various reasons including self-determination of risk (or lack thereof), belief that the value of donation to others outweighs the risk concerns, belief that testing would identify all infected blood, and fear that disclosure of MSM status is linked to "coming out."

In Australia, which implemented a 1-year deferral policy in 2000, there was no change in the number of HIV-positive donors before and after policy change. Noncompliance was determined to be the factor most likely to influence overall risk, rather than the duration of the deferral.

Since 1984, the Australian Red Cross has had a policy requiring all blood donors to initial and sign a statement in the presence of a witness saying they understand the information on the form, they have answered the questions honestly to the best of their knowledge, and they understand there are penalties, including fines and imprisonment, for providing false or misleading information.

No structural studies of that statement have been made thus far. In the United States, an assessment of the effectiveness of the donor history questionnaire was also among the recommendations that were made by the HHS panel and endorsed by the FDA advisory committee.

Dr Jackson expressed confidence in the FDA's ability to sort through the complexities of this issue and come up with the best policy. "I think the FDA [blood products team] is extremely reasonable, scientifically, as well as in policy. I've been doing blood banking since 1971. It's a great group."

FDA advisory committee members are vetted for conflicts of interest and waivers are granted for participation if necessary. No waivers were granted for this meeting.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....