- The Washington Times - Thursday, September 14, 2000

An advisory committee to the U.S. Food and Drug Administration today will consider changing federal regulations to allow most homosexual and bisexual men to donate blood to blood banks.

Homosexual and bisexual men, who comprise the majority of Americans infected with HIV, the virus which causes AIDS, have been banned from donating blood for 15 years.

Proponents of allowing more homosexual and bisexual men to give blood argue that the current policy against them is "discriminatory." But current and former intravenous drug users and hemophiliacs who have used clotting concentrates made from blood are similarly prohibited, as are those who have visited or lived in Nigeria, Cameroon and six other sub-Saharan African nations.

The proposal, backed by the American Association of Blood Banks, would allow donations by men who say they have not had sex with other men for at least a year and who pass nine tests to detect the presence of HIV and other viruses, such as hepatitis B and hepatitis C.

"We think this is fair, since there are new tests that detect infectious diseases earlier," said Sara Foer, spokeswoman for blood banks. "Our highest priority is to enhance the safety and availability of blood. We believe this change would not compromise that."

One test in routine use at blood banks today, she said, can detect the presence of HIV 16 days after infection. Another test already in use at some blood banks can detect HIV's genetic material eight to 12 days after infection.

Current regulations initiated in 1985 prohibit men from donating blood if they have engaged in homosexual or bisexual relations since 1977. That date corresponds with the earliest known cases of AIDS, even though the federal Centers for Disease Control and Prevention did not officially begin tracking AIDS until four years later.

"We are asking the Blood Products Advisory Committee to consider shortening that period," an FDA official who asked not to be identified said yesterday.

She declined to say whether the FDA is promoting such a change, but acknowledged it "may have an opinion" on its feasibility.

Dr. Michael Busch of the Blood Centers of the Pacific in San Francisco, an organization that has been in the forefront of efforts to lift the ban on blood donations by homosexual and bisexual men, said yesterday he believes the FDA favors a five-year period of abstinence before such men can donate blood.

Dr. Busch believes the window period for homosexual males should be comparable with those of other high-risk heterosexual populations, such as female prostitutes, those who have sex with prostitutes, and those who have sex with intravenous-drug users. Persons in those exposure categories are barred from donating blood for one year.

The advisory committee, which meets today in Gaithersburg, Md., cannot make a change itself. It can only recommend action to the FDA.

In the early days of the AIDS epidemic, homosexuals who donated blood or blood plasma were responsible for infecting thousands of hemophiliacs and blood-transfusion recipients with HIV.

At that time, six to eight months were required before a person infected with the virus tested positive for the antibodies. There was concern that homosexuals or others at high risk for HIV might donate blood before there was any sign of infection.

"You can't totally rule out" the possibility of transmitting HIV infection to someone who gets a blood transfusion today, Mrs. Foer said.

But with the sensitive screening that's done, only the blood of persons infected in the previous eight to 16 days could slip through, she said.

However, there is a major public outcry any time such transmission occurs.

Currently, the risk of HIV infection from a blood transfusion is calculated to be 1 in 800,000 screened units of blood, Mrs. Foer said. That compares with calculations of 1 in 420,000 units in 1995 and 1 in 225,000 units in 1992.

This will be the second time since late 1997 that the Blood Products Advisory Committee to the FDA has been asked to consider lifting the prohibition against blood donations by most homosexual males.

The advisory panel declined to recommend changing the policy in 1997. "It felt it did not have enough information then on whether such a change would have an impact on the blood supply," the FDA official said.

The FDA's present "blood-donor deferral policy was based on science," and science would be the guiding factor in any changes that might be made, she said.

The American Red Cross, which collects about half of the nation's blood and is the largest member of the American Association of Blood Banks, has also been asked by the FDA to comment on the proposed change.

"The Red Cross is currently formulating the data, but at this point, it does not have a recommendation," spokeswoman Blythe Kubina said yesterday.

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