A federal panel on blood safety will make a recommendation Friday about whether the Food and Drug Administration (FDA) should change its blood donation policy for gay men.
The FDA is “considering all possible sources of information” about the issue, Dr. Howard Koh, assistant secretary for health at the Department of Health and Human Services, told the FDA’s Advisory Committee on Blood Safety and Availability.
“We always make our decisions based on the best science possible,” Dr. Koh added, stressing the themes of safety and prevention.
Current FDA policy says that men who have had sex with men (MSM) even once since 1977 are deferred indefinitely as blood donors.
Gay rights groups and a number of U.S. senators, led by Sen. John Kerry, Massachusetts Democrat, are urging the FDA to drop its “antiquated” policy and allow gay men to donate blood if they have not had sex with a man in recent time periods, such as a year or five years.
Groups representing hemophiliacs and other blood end-users want the FDA to continue its MSM-deferment policy.
The MSM policy was set in the mid-1980s after some 29,000 people acquired HIV/AIDS from blood transfusions. The first U.S. AIDS case was confirmed in 1977.
At Thursday’s hearing in Rockville, Md., Dr. Jay Epstein, director of the FDA Office of Blood Research and Evaluation, said the risks for getting HIV from a blood transfusion are now “astonishingly small” — about one in 1.4 million units.
Still, he said, “We should be cautious about tampering with success that has come with great effort.”
While HIV infection has been declining in other populations, it has increased among MSM, medical experts said.
Compared to the general population, MSM have roughly 44 times the HIV prevalence of other men, and 40 times the prevalence of women, said Amy Lansky, an official with sexual disease surveillance with the Centers for Disease Control and Prevention (CDC).
If the FDA policy was changed, two options used by other countries would be to allow men to donate blood if they had not had sex with a man within the past year or the past five years.
FDA modeling shows that if a five-year deferral for MSM was put in place, it would add 14,700 new donors, and 300 units of HIV-positive blood, said Dr. Epstein. If the FDA set a 12-month deferral for MSM, it would add 75,000 donors to the pool, and 1,600 more HIV-positive units.
In contrast to FDA modeling, based on reports from blood banks and the American Red Cross, there have been only a handful of “transfusion-associated transmissions” of HIV in recent years, said Dr. Bernard Branson, an official with the CDC’s laboratory diagnostics section. So even though the risk of HIV transmission is estimated to be in one in 1.4 million units, “the observed frequency” is one in 10 million, he said.
The hearing continues Friday, and at its conclusion, the blood safety panel is expected to vote on a policy recommendation for FDA officials.