The federal government is on the brink of lifting restrictions put in place more than three decades ago when regulators, alarmed by the spread of the virus that causes AIDS, barred men who had sex with other men from donating blood.
A Food and Drug Administration advisory panel will begin a two-day meeting on the issue Tuesday, amid growing calls from medical groups, gay rights activists and lawmakers to jettison the ban as outdated and discriminatory.
An advisory group for the Department of Health and Human Services recently recommended, for the first time, that the ban be replaced with a 12-month deferral period, which would prohibit male potential donors who have had same-sex contact over the previous year from giving blood. The FDA, which regulates blood donations, will consider that recommendation as part of its decision.
When the human immunodeficiency virus, or HIV, was detected in the United States, researchers knew little about it or its connection to what became known as acquired immune deficiency syndrome, or AIDS. Reliable screening did not exist, and cases of what was known as “gay-related immune deficiency” were soaring.
Government health officials were worried that gay and bisexual men, who as a group had a much higher risk of contracting HIV and other transmissible infections such as hepatitis B, posed a danger to the nation’s blood supply. In 1983, the FDA put in place the beginnings of a policy that remains today: Any man who has had sex with another man — even once — since 1977 is prohibited from donating blood.
“FDA realizes that this policy leads to deferral of many healthy donors,” the agency says on its Web site. “However, FDA’s [current] policy minimizes even the small risk of getting infectious diseases such as HIV or hepatitis” through a blood transfusion.
“They really are out of step with the rest of the world,” said Glenn Cohen, a Harvard Law School professor who with two colleagues recently argued in the Journal of the American Medical Association for a new U.S. policy.
Cohen noted that numerous countries have abandoned blanket bans and put in place shorter deferral periods. For instance, in Australia, Japan and Britain, a gay man who wants to donate blood must have been abstinent for a year. Canada has a five-year deferral period. South Africa asks anyone who has had sex with a new partner in the past six months to wait before giving blood, regardless of sexual orientation or gender. Italy assesses each potential donor’s risk on the basis of individual behaviors.
Over time, scientific advances have allowed better and quicker testing for HIV, as well as better monitoring and treatment of AIDS. Blood donations in the United States are tested for HIV and other possible infectious agents, and the blood supply overall is considered highly safe. While there is a brief period in which tests cannot detect HIV in someone who has just been infected, experts say a one-year deferral period is more than sufficient to account for that risk.
The move toward a revised U.S. policy has been gaining steam for years, as medical groups, academics and even politicians have increasingly spoken in favor of lifting the ban.
The American Medical Association last year backed a change, with one board member saying the policy “is discriminatory and not based on sound science.” The American Red Cross, America’s Blood Centers and AABB, a standards-setting group based in Bethesda, Md., have long supported a 12-month deferral. In 2010, then-U.S. Sen. John F. Kerry (D-Mass.) and 17 of his colleagues wrote to the FDA, saying that “healthy blood donors are turned away every day due to an antiquated policy and our blood supply is not necessarily any safer for it.”
Even the American Plasma Users Coalition, a group of patient organizations representing people with certain rare diseases, which had previously argued that there was not enough scientific data to support a policy change, now says enough evidence exists.
“We believe the recently released research provides a scientific basis for revising the current lifetime deferral policy for [men who have sex with men] to a one-year deferral,” the group wrote in a statement to be presented to the FDA’s advisory committee, adding that such a change must be accompanied by a strong vigilance program. “This policy reflects a balance of respecting donors and protecting patients.”
Such endorsements far outnumber whatever scant support remains for the full ban, primarily among individuals who oppose blood donations from gay men on moral grounds. Even then, the topic has drawn far less opposition than other gay-rights issues, such as same-sex marriage.
“The moral compass has shifted,” Cohen said. “We got rid of ‘Don’t Ask, Don’t Tell.’ You can shed your own blood for the country [if you’re gay]. But you can’t donate your blood to your fellow man? A lot of people take that as a second-class citizenship status.”
Jay Menitove, a Kansas City doctor who chaired the HHS advisory committee, said the one-year deferral “can be looked at as a starting point.” He added: “The sense was if we made a change, the incremental risk to the safety of the blood supply would be very, very low. . . . I think we did the right thing.”
Ultimately, whatever the FDA decides — and it generally follows the recommendations of its advisory panels but is not required to do so — will not have a huge impact on the size of the nation’s blood supply. A 2010 study by the University of California at Los Angeles found that lifting the ban fully could increase the total annual supply of donated blood by between 2 and 4 percent, adding as many as 615,000 pints per year. A shift from the full ban to a 12-month deferral could add about 317,000 pints a year.
Those pushing for change say a new policy would acknowledge current science and send an important, and overdue, cultural message.
“The evidence is there; they’re just being cautious about implementing it,” said Ryan James Yezak, founder of the National Gay Blood Drive. “[But] we will get to where we want to be. . . . People want to serve their country. They want to do this thing that other humans partake in. Not being able to do this is wrong.”