HHS Considering Study on Blood Donation Standards for Gay and Bisexual Men

By Jane Norman, CQ HealthBeat Associate Editor
The Department of Health and Human Services wants input on how to design a study that would detail under what circumstances men who have a history of sex with other men should be allowed to donate blood.
Under current Food and Drug Administration policy, men who have had sex with other men since 1977 – the dawn of the AIDS epidemic – are not allowed to donate blood. But a request for information posted by HHS on the Federal Register asks for comments on a pilot study that would look at ways to allow blood donations by some gay or bisexual men who are not at high risk for HIV infection.
The lifetime ban on blood donation by men who have sex with men has been questioned by advocacy groups and recently by Democratic members of Congress, including Sen. John Kerry of Massachusetts and Rep. Mike Quigley of Illinois (
According to the FDA’s website: “A history of male-to-male sex is associated with an increased risk for the presence of and transmission of certain infectious diseases, including HIV, the virus that causes AIDS.”
The agency adds: “FDA’s policy is intended to protect all people who receive blood transfusions from an increased risk of exposure to potentially infected blood and blood products.”
Similar policies are in place in Europe, though England, Scotland and Wales now allow men to donate blood as long as they have not had sex with another man in the past year or engaged in other risky behavior, according to The Guardian newspaper.
The FDA notice says the risk of infection from a blood transfusion is now “extremely low” and risks have dropped dramatically during the past three decades because of safeguards that are in place. If an infection occurs now, it’s due to a deficiency in the donor screening process, the failure of a donor to provide accurate answers, donations during a period when someone’s infection can’t yet be detected or inadvertent release of donated blood before testing results are known, the notice says.
Advisory committee meetings and a public workshop have been held to examine the policy and have taken into account current scientific evidence, according to the notice. “In addition, there has been increased interest in changing this policy from some members of the U.S. Congress, the public and interested advocacy groups,” it adds. In June 2010, an HHS committee called the current policy “suboptimal” while recommending it be kept, pending research.
So now, health experts are asking for input on questions such as whether blood donations might be accepted from men with one or five years of abstinence from sex with other men; the impact on blood centers of adopting new policies; staff training and staff perceptions; tracking of results before blood donation and afterward; the willingness of blood organizations to take part in a pilot; and more.
The notice says the concept is to do a pilot study in which homosexual or bisexual men who meet set criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients. Data would be gathered to figure out whether the criteria were effective in finding low-risk donors, and at the conclusion of the study there would be a “transparent and evidence-based evaluation” of all current and future policies on blood donations.
 
HFA will definitely be weighing in on this issue and providing comments to HHS. To read the Federal Register Notice go here.