Easing blood donor guidelines for gay men

Feb. 19, 2015

I’m going to let other people write most of my column this month—but I have some pretty good proxies: the U.S. Food and Drug Administration, the Red Cross, AABB. 

From an FDA statement by Commissioner Margaret Hamburg:

“Over the past several years, in collaboration with other government agencies, the FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men, including the results of several recently completed scientific studies and recent epidemiologic data. Following this review, and taking into account the recommendations of advisory committees to the U.S. Department of Health and Human Services (HHS) and the FDA, the agency will take the necessary steps to recommend a change to the blood donor deferral period for men who have sex with men from indefinite deferral to one year since the last sexual contact.

“This recommended change is consistent with the recommendation of an independent expert advisory panel, the HHS Advisory Committee on Blood and Tissue Safety and Availability, and will better align the deferral period with that of other men and women at increased risk for HIV infection. Additionally, in collaboration with the NIH’s National Heart Lung and Blood Institute (NHLBI), the FDA has already taken steps to implement a national blood surveillance system that will help the agency monitor the effect of a policy change and further help to ensure the continued safety of the blood supply.

“The FDA intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment. We encourage all stakeholders to take this opportunity to provide any information the agency should consider, and look forward to receiving and reviewing these comments.”

From a response issued by the American Red Cross, America’s Blood Center, and the AABB: 

“AABB, America’s Blood Centers and the American Red Cross believe all potential blood donors should be treated with fairness, equality and respect, and that accurate donor histories and scientifically supported donor deferral criteria are critical to the continued safety of blood transfusion.

The FDA’s decision to take steps to recommend a change in the blood donation deferral for men who have had sex with men (MSM) from a lifetime deferral to a one-year deferral is consistent with the position of our organizations that the current lifetime deferral is unwarranted.

It is important to note that this process is just beginning and that the lifetime blood donation deferral for MSM is currently still in place. Blood centers comply with all FDA blood donation eligibility criteria. The process to change this will take time. We will review the draft guidance that is scheduled to issue in 2015, and will implement the guidance as soon as possible after it is finalized.

The top priority of AABB, America’s Blood Centers and the American Red Cross is the safety of the ultimate recipients of blood and our volunteer blood donors. Our organizations strongly support the use of rational, scientifically-based deferral periods that are applied fairly and consistently.…”

To my knowledge, no reputable organization in the blood industry has voiced opposition to the FDA proposal. With our current ability to screen blood for pathogens, even the one-year restriction may be overcautious.

Having said that, let me play the devil’s advocate for a just moment: might it be a good idea to “make assurance double sure,” in Macbeth’s phrase, and be very conservative about this? AIDS was never really a “gay disease,” even at the beginning, and it certainly isn’t now, but, statistically, there will probably be a higher proportion of HIV-positivity among “MSM” than in the overall population.

The issue is arguable, and it will be argued, but I side with the FDA and the allied organizations: Public health policy should be based on science, not prejudice or vague feelings of unease, and it should reflect “fairness, equality and respect.”