AEGiS-BAYW: No removal in sight of gay blood donor ban: FDA holds firm on policy of deferring men who have sex with men Bay WindowsImportant note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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No removal in sight of gay blood donor ban: FDA holds firm on policy of deferring men who have sex with men

Bay Windows - November 18, 2004
Linda Rodriguez


When Elvedin, a 24-year-old graduate student in the Boston area, went to give blood at a local Red Cross donation center recently, he didn't come away with a good feeling and an "I gave blood today" sticker. He came away feeling discriminated against.

"There was a question on the donor questionnaire, something like 'Are you a man who has had sex with another man since 1977?'" said Elvedin, who asked that his last name not be used. "I felt very uncomfortable answering that question and I didn't really want to."

After finishing the rest of the questionnaire, Elvedin returned the form to the screener, noting that he didn't answer the question and that he felt it was discriminatory against gay men and that it wasn't relevant. They directed him to a supervisor.

"They were really nice and I think sympathetic to what I was saying," said Elvedin. "I don't think that the person in charge agreed with the questionnaire." He was told by the supervisor that men who have sex with men (MSM) are at higher risk of contracting HIV/AIDS and that if he had answered "yes" to the question, they wouldn't take his blood.

"I was really offended," he continued. "I just felt like I was being discriminated against because of my sexual orientation."

Elvedin's experience isn't unique. Since 1983, all blood centers in the United States, at the behest of the Food and Drug Administration, have deferred all men who answer the question positively, regardless of their HIV status or sexual behavior. A man who has had sex with a man even once since 1977 - before Elvedin was even born - will be deferred from giving blood.

"We are regulated by the federal government, so we do what they say or we get shut down," said Deborah Drikell, a representative for the New England Region of Red Cross blood services. "We get a lot of requests and concerns from college students and we have to say it that it is the FDA."

The AIDS epidemic first came to the U.S. in 1977, exploding among gay men in the early 1980s. So much so that by 1985, the FDA had to begin implementing plans to make the country's blood supply safer. In addition to the permanent ban on donated blood from MSM, all donors admitting to using illegal drugs with a needle since 1977 are also on the deferral list.

Over the nearly 20 years of the ban's existence, the Blood Products Advisory Committee (BPAC), an advisory board to the FDA, has examined the issue of the MSM blood deferral several times and each time concluded that the risk of HIV/AIDS infection in the blood supply is simply too great to relax the ban. According to FDA findings presented at the 1997 advisory meeting, approximately 103 HIV-infected units of blood get into the blood supply each year, which are then interdicted by tests. They then calculated that by relaxing the MSM ban that number could double or triple.

In 2000, another BPAC meeting was called to discuss modifying the ban by striking the "since 1977" clause and re-figuring it as "in the last five years" or "in the last year." The committee invited members of the American Association of Blood Banks (AABB), Gay and Lesbian Medical Association (GLMA), the Committee of 10,000 and the American Red Cross, among others, to present their sides of the issue.

Dr. Adrienne Smith of GLMA, speaking at the blood advisory meeting, said, "The principle is [that] like risks should be treated alike. This maxim exposes the central flaw in the current donor deferral policy, which tolerates a wide range of risks associated with heterosexual sex while imposing a zero tolerance attitude towards MSMs, regardless of the risks associated with individual behavior."

Despite recommendations from the AABB, America's Blood Centers, and GLMA to relax the ban and statements that a change in the deferral policy would not substantially increase the risk of HIV transmission through blood products, the deferral stood. The FDA later stated that in the absence of good data to the contrary, they were forced to rely on worst-case-scenario information, including studies conducted by the FDA showing that modifying the deferral might result in an additional 1200 units of HIV-positive blood to enter the testing system each year, based on calculations placing the estimated HIV-prevalence rate among the MSM population at two percent.

Though there are no plans to revisit the issue in the near future, the FDA does anticipate revisiting it at some time.

"The FDA is committed to goals that protect public health and we're driven by science," an FDA official said. "We reject donors based on established risk factors. The health of the nation's blood supply and those receiving it comes first. In effect, if you even increased the risk of infection by even one person, it would not be acceptable."

Currently, men who have sex with men comprise the largest group of HIV/AIDS infected individuals in the country, according to CDC numbers, and male-to-male sex is still the primary way HIV/AIDS is transmitted, despite the growing number of heterosexual transmissions. However, according to a number of opponents of the ban, it is the superficial examination of data like that which leads to an ill-informed and potentially hazardous deferral.

"I don't think it's practical," said Denise McWilliams, director of policy with AIDS Action Committee of Massachusetts. "I think it's both under and over inclusive. It's under-inclusive because there are many men who are not gay men who engage in high risk behavior. There's all sorts of people you're just not going to be picking up on with this deferral. And it is over-inclusive because there are God knows how many gay men who have not engaged in risky behaviors."

McWilliams, a former attorney, sees the ban not as a matter of discrimination, but rather as an economic issue, citing the capability of viral-load testing to shrink the window period for HIV/AIDS infections detection, and ultimately the result of superficial analysis.

"I think the reality is if you really want to do it [blood collection] in the most effective way, you have to do testing and you have to do viral load testing," she said. "I think, at heart, it's an economic decision. And people who haven't really examined the issue are going to feel comforted by this decision, because the 'problematic' people are being cut out.

"If you look at the ban in 1985, it made sense because we had no other options," she continued. "But now, we have options. It's also true that safety has a cost."

At the moment, the cost of safety for the FDA is the continued deferral of willing gay male donors, a potentially high cost during times of blood emergencies, such as after the terrorist attacks of Sept. 11, 2001, a cost that they're willing to pay, they feel, to reduce the risk to American blood supplies.

For Elvedin, a young gay man, explanations of the FDA's position are only partially soothing. "It wasn't even about me not being able to give blood," he said. "It was that I felt completely discriminated against."


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