San Francisco Chronicle Tuesday, September 12, 2000
Christopher Heredia, Chronicle Staff Writer
A proposal backed by the American Association of Blood Banks, an industry advocacy group, would permit donations by men who have not had sex with other men for one year. It will be considered Thursday by the Blood Products Advisory Committee of the U.S. Food and Drug Administration during a meeting in Gaithersburg, Md.
Supporters of the proposal, including some federal health officials, will testify that advanced tests can reveal the presence of HIV in a matter of weeks after infection. The tests may be reason to lift the 15-year-old rule that prohibits men from donating blood if they have had sex with other men after 1977.
The advent of the AIDS crisis prompted the FDA to impose the prohibition. Before 1985, thousands of people developed AIDS through contaminated blood transfusions.
But today, experts say, new tests are in place that can detect the virus's genetic material just 20 days after infection. That represents "a big step forward" and is cause to reconsider the ban, said Dr. F. Blaine Hollinger, a medical professor from Houston and chairman of the FDA's committee on blood products.
"Now that we have better questionnaires and screening and the tests are more sensitive, perhaps the time has come that we could make another decision regarding the length of time one would want to delay allowing (a gay man) to donate," Hollinger said.
Advocates for lifting the ban, including gay San Francisco Supervisor Mark Leno and the Blood Centers of the Pacific, have called the current policy discriminatory because it focuses on gay men and doesn't address the rise in HIV infections among heterosexuals.
"I've said all along that the prohibition against gay men donating blood, especially through this period of severe blood shortages, is wrong," Leno said.
Homosexual and bisexual men are not the only ones prohibited from giving blood. There are also bans against current and former intravenous drug users, people who have worked as prostitutes during the last 23 years, those who have had sex with prostitutes in the last year, hemophiliacs who have received clotting factor concentrates and people who have visited or lived in Nigeria, Cameroon and six other African countries since 1977.
Nationwide, people donate about 12 million pints of blood per year. In recent months, blood banks -- including the Blood Centers of the Pacific -- have issued emergency appeals for more donors.
Dr. Michael Busch of the Blood Centers of the Pacific in San Francisco, who will attend Thursday's meeting, said the current ban doesn't make sense. He predicts that federal officials will relax the ban, but will probably side with a national hemophiliacs organization that wants a five-year period of abstinence before gay and bisexual men can donate.
"It makes sense to make the window period more analogous to other high-risk behaviors, like heterosexual sex with multiple partners," Busch said. The advisory committee will make its recommendation to the FDA. If it's a favorable recommendation, the FDA could then undertake its own studies. A spokeswoman for Health and Human Services Secretary Donna Shalala said Shalala probably will support the FDA's final decision.
The committee will step cautiously through controversial terrain, Busch said. With every HIV infection from a blood transfusion -- an estimated 1 out of 700,000 pints of blood -- there is tremendous public backlash.
"It's a difficult environment," he said. "There continues to be a lot of misunderstanding and concern on the public's part. The safety of the public blood supply is extremely important. This could be a defensible first step that gets us part of the way."
Last year, Blood Centers of the Pacific collected 100,000 units of blood. Only three of those units tested positive for HIV, center officials said. "Where do you draw the line?" Busch said. "It's an equity issue. Why is it OK for a woman who has had anal intercourse to donate blood but not for a gay man who is HIV negative? The data does justify relaxing the window period." Leno, who has lobbied the FDA for years to lift the ban, called the consideration of the 12-month period "a step in the right direction."
But he added that he isn't sure how much it will help, given that few people abstain from sex for 12 months.
"The FDA should be asking appropriate questions, not whether you're a man who has sex with men, but what kind of sexual activity you've engaged in," Leno said.
Sara Foer, spokeswoman for the American Association of Blood Banks, said her organization will advocate a 12-month window "because we don't believe the safety of the nation's blood supply will be impacted" by the change. Blood collected at banks across the country are screened by nine tests for infectious diseases, Foer said.
"It's a change that isn't going to be made unless there is a 100 percent belief that the safety of the blood supply will be protected," she said. Leno said that may take time.
"Over time, it will be substantiated there there is no added risk to the safety of the nation's blood supply from gay men donating," he said. "It's not with whom you have sex, it's the kind of sex you're having. If you have practiced safe sex, your blood will be negative.
"The FDA has set themselves up for a tough task."
E-mail Christopher Heredia at cheredia@sfchronicle.com.
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