FDA Considers Allowing Blood Donations From Some Gay Men
The Food and Drug Administration is considering revising a ban on blood donations from men who have had sex with other men.
An FDA advisory committee Tuesday mulled the issues raised by changing the policy, which has been in effect since the early 1980s.
While the committee did not take a formal vote, some members said they favored changes to the policy that would not threaten the safety of the blood supply. One suggested solution (and the policy of several other countries) would permit donations from men who have gone a year or more without having sex with another man.
"The blood bank community has looked at the data and feels they can scientifically and medically support the change," said Dr. Toby Simon, senior medical director of the CSL Behring.
But others expressed concern that such a change might increase the risk of getting infected through a blood transfusion.
"Even if this leads to one or two cases of HIV infection, that's not acceptable," said Kenrad Nelson, a professor of epidemiology, international health and medicine at Johns Hopkins Medical Institutions.
Since the early 1980s, any man who tells a blood bank he's had sex with another man at some point since 1977 has been banned from donating blood. The policy was created in the early days of the AIDS epidemic, before scientists had discovered the human immunodeficiency virus, or developed good tests to screen blood for HIV. The ban was considered important to protect people from getting infected with the virus through transfusions.
But the policy has been the subject of intense debate for years. Gay rights advocates argue that it's discriminatory. They point out that while gay men may be at higher risk than the average blood donor of being infected with HIV, so are many other people — including intravenous drug users, sexually promiscuous heterosexuals, and heterosexual men who have had sex with a prostitute.
Another federal advisory committee, which advises the Health and Human Services Department, voted overwhelmingly a few weeks ago to change the policy. Under that committee's recommendation, men who have had sex with men would be allowed to donate if they have been celibate for at least a year. Several other countries, including Australia, Japan and Britain, have adopted similar policies.
The FDA will consider that recommendation, along with the discussion at Tuesday's hearing, in deciding whether to change its policy and in what way. The agency has not said when it might act.
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Transcript
AUDIE CORNISH, HOST:
A ban on blood donors that dates back to the early days of the AIDS crisis is being reconsidered. An advisory panel from the Food and Drug Administration debated whether to lift the ban on blood donation by men who have had sex with other men.
NPR health correspondent Rob Stein has been following that discussion, and he joins us now. And Rob, just start by reminding us what the current policy is and how it came about.
ROB STEIN, BYLINE: Well, Audie, right now, any man who has had sex with another man even once since 1977 is barred for life from ever donating blood. And now, you have to remember, this ban was put into place in the early days of the AIDS epidemic when we didn't know a lot about HIV and AIDS. We knew that it was spreading among gay men, but we didn't know it was caused by HIV. And we didn't have any test to screen blood donations. So this was considered a really important step to protect people from getting infected from a blood transfusion.
CORNISH: So what happened at today's meeting?
STEIN: So the FDA Advisory Committee heard lots of scientific information, and they also heard from the public. They heard from gay rights advocates and others who urge making a change in this policy, saying it was unnecessary. It was outdated. And it unnecessarily stigmatized gay men. And some advocates for patients who regularly receive blood products expressed some concern, though, that it may jeopardize the safety of the blood supply. In the end, the committee didn't actually take any formal votes on this, but committee members did express their views on this, and it seemed very mixed. Some committee members said, yeah, we think it's time to change this policy. It's really outdated. Others said, well, I'm not so sure. I'm really concerned about making a change and the effect it might have on the safety of the blood supply.
CORNISH: Rob, this discussion's been going on for a long time. I mean, why is the FDA considering making a change now?
STEIN: You know, this is - policy's been debated for a really long time now. Critics of the policy have argued for years that it just doesn't make any sense. And it's outdated scientifically. And it's time to really rethink things. First of all, they argue it's basically discriminatory because it singles out gay men. You know, yes, they are at higher risk for being infected with the AIDS virus. But so are a lot of people, like people who inject drugs and heterosexual men who have had sex with a prostitute or sexually promiscuous heterosexuals. So they argue there's no reason to impose greater restrictions on, say, an HIV-negative gay man who's been in a long-term monogamous relationship with another HIV-negative man.
CORNISH: And we've been talking about the FDA, but I understand a committee that advises the Health and Human Services Department recently recommended changing the policy. Can you tell us more about that?
STEIN: That's right. That's right. This committee debated all this about three weeks ago, and that committee voted overwhelmingly for the first time to change the policy. Those advisers recommended that gay men only be barred from donating blood for one year since they last had sex with another man. So sexually active gay men would still be prohibited from donating blood, but those who have been celibate would bailout to donate.
CORNISH: Aside from government panels, who else is supporting this change?
STEIN: Well, of course, gay rights groups are supporting it, but also doctors' groups like the American Medical Association and groups like the American Red Cross and other blood banks. They've all been calling for making a change. So there seems to be some momentum towards lifting the ban. And one big reason is that it would provide hundreds of thousands of badly needed pints of blood for blood transfusions.
CORNISH: Now, is there a risk of spreading the virus if the ban is changed?
STEIN: Well, there is what experts call a window period. And that's a period between the time when someone gets infected with the AIDS virus and when the test can pick it up. So yes, screening isn't fool-proof and doesn't guarantee that someone's blood is safe. But studies have shown that deferring donation for a year after the last time a man had sex with another man would be plenty of time to reduce the risk if their blood is actually infected.
CORNISH: Well, what happens next with the FDA?
STEIN: Well, it's up to the agency to make a final decision. And they say they're going to take all the information that was presented at today's hearing into consideration, along with the other committees' recommendation, and make a decision. They aren't saying when.
CORNISH: Rob Stein, thanks so much.
STEIN: Oh, sure. Nice to be here.
CORNISH: That's Rob Stein, NPR health correspondent. Transcript provided by NPR, Copyright NPR.
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