FDA inches toward easing gay blood donation ban

Thursday, March 16, 2006

FDA inches toward easing gay blood donation ban

The lifetime ban on gay men donating blood may be eased to a 12-month deferral if scientific evidence presented at a March 8 workshop in Bethesda, Maryland is turned into policy guidance by the Food and Drug Administration. All of the major players in the blood products industry now support that position.

The FDA policy adopted in 1985 recommended deferral of blood donations by populations based upon their risk behaviors for the transmission of HIV. Little was known about HIV at the time and the test to screen blood for the presence of HIV was new and of questionable accuracy. Excluding the highest risk individuals, then gay men, made sense.

Blood screening tests have been improved over the years so that they detect the actual virus itself, not just the antibody to it, which takes longer to develop. There is only a very brief period of 10-21 days after initial infection when the virus might not be detected.

Men who have sex with men currently are banned for life from donating blood, even if they are in a monogamous relationship. Injection drug users and commercial sex workers can donate blood once they had abstained from those activities for at least a year.

The FDA revisited the policy in September 2000, suggesting that increased knowledge of HIV and improved technologies for screening blood for the virus had made it possible to modify the gay exclusion from a lifetime ban to a 12-month exclusion, in line with other high risk groups.

The American Association of Blood Banks, the association of transfusion medicine professionals, and America's Blood Centers, representing local organizations that collect nearly half of all blood in the U.S., both supported the modification. Only the American Red Cross testified against the change, and that was sufficient for the advisory committee to vote 7-6 not to support changing the guidelines in 2000.

This time around the Red Cross fell into line and in a joint statement presented by AABB senior medical adviser Steven Kleinman, the three organizations called the lifetime ban for gay men "medically and scientifically unwarranted." It recommended making the deferral criteria the same for all high-risk groups.

They also warned the FDA, "The continued requirement for a deferral standard seen as scientifically marginal and unfair or discriminatory by individuals with identified characteristics may motivate them to actively ignore the prohibition and provide blood collection facilities with less accurate information."

An additional concern is that grassroots opposition to the ban has arisen in high schools and on college campuses across the country over what many see as a discriminatory policy. That has made it more difficult to conduct blood drives among younger volunteers and establish patterns of regular donations that can last a lifetime.

To help ease any remaining qualms about changing the policy, the groups offered to assist in gathering data on its impact, should it become advisable to revisit the proposed change.

The FDA Blood Products Advisory Committee was briefed on the workshop when it met the following day, but it was not asked to comment. The FDA may propose revising its donation guidelines later in the year.

The advisory committee also discussed the FDA's proposed procedures to review and approve over the counter sales of tests for HIV. The company that makes the OraQuick saliva test to detect antibodies to HIV has said that it will seek such approval, and after the meeting said it would move forward with the types of trials outlined by the FDA.

The OraQuick test is widely used by public health agencies to screen for the virus both within clinics and at mobile sites. Some HIV agencies say that making the test more easily available runs the risk of inadequate counseling to what the test means and linking those who test positive to services, while others support wider access under appropriate safeguards.