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Originally Posted by [b
Quote[/b] ]FDA Committee Votes Against Relaxing Donor Ban
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By Becky Orfinger, Staff Writer
For the past 15 years, any man who has had sex with another man since 1977 — even once — has been permanently banned from donating blood because of the high prevalence of AIDS in the gay male population. At a meeting yesterday of an advisory committee to the Food and Drug Administration, government scientists voted to uphold this policy, cited as discriminatory by many gay rights activists.
FDA medical officer Andrew Dayton asked the Blood Products Advisory Committee (BPAC) whether it was prudent to change the donor deferral policy to ban only men who disclosed having sex with another man within the last five years. Dayton and his colleagues analyzed the projected risk that relaxing the donor deferral rule would have on the nation's blood supply and presented the committee with this data. After much deliberation, the BPAC members voted 7 to 6 to maintain the current deferral policy.
Dr. Rebecca Haley, interim chief medical officer for the American Red Cross, told the committee that the Red Cross did not support changing the current ban on blood donation by from men who have engaged in homosexual behavior during the past 24 years because of the risk of introducing HIV-positive blood into the national blood supply. Although Dayton's risk analysis found that "introduction of a five year floating deferral for male-to-male sexual behavior, even using conservative estimates, would result in minimal increased morbidity in the blood supply by HIV," the Red Cross urged caution in changing a policy that so far has kept the blood supply virtually free of tainted blood.
CNN
"If the Public Health Service could assure us that introducing previously deferred donors into the pool could be accommodated without increasing risk, the American Red Cross would support appropriate actions to do so," Haley said.
Dayton estimated that there are 62,300 men who want to donate blood, but are prohibited from doing so by the current law. Considering the known incidence and prevalence rates of HIV infection in this population, he said, changing to a five-year deferral policy could potentially introduce 1,246 units of HIV-positive blood into the system to be screened. Testing done on each of these units would likely result in an added 1.7 units of HIV-infected blood into the nation's blood supply, experts said at the meeting. Changing to a one-year deferral policy — another option that was presented to the FDA for review — would add about 112,000 additional HIV-positive blood units to the blood system for testing. After screening, approximately 6 additional units of HIV-positive blood units would enter the blood supply, according to Dayton's estimation.
CNN
The serological tests routinely performed on all donated blood to detect HIV and other blood-borne viruses are sensitive enough to prevent all but about 10 HIV-infected units from entering the blood supply each year, said Dr. Michael Busch of the University of California-San Francisco. The infected blood that does defy the rigorous testing protocol causes two to three HIV infections each year, he said.
Dr. Adrienne Smith, of the Gay and Lesbian Medical Association, told the committee that the current donor ban stigmatizes gay men. She said that it is unfair that donors who disclose having engaged in risky heterosexual behavior are only deferred from donating for a year, not for a lifetime. "Like risks should be treated alike," Smith said.
But Dr. Jay Epstein, director of the FDA's Office of Blood Research and Review, said that epidemiological data has clearly shown that males who engage in high-risk sexual behavior are much more likely than their heterosexual counterparts to become infected with HIV. Haley also stressed to the committee that the decision to uphold the lifetime ban on men who have had sex with other men should be based on scientific evidence, not societal pressures.
"The safety of the blood supply — and the patients we ultimately serve — must be our number one priority. This is a public health issue. Not a social policy issue," she told the committee.
© Copyright 2000, The American National Red Cross. All Rights Reserved.
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