FDA changes rules for donating blood. Some say they're still discriminatory
SACHA PFEIFFER, HOST:
For decades, the Food and Drug Administration barred men who have sex with other men from donating blood. It was a policy considered discriminatory by the LGBTQ community and other critics. And this week, the FDA announced it would change its requirements. Instead of broadly excluding gay and bisexual people from donating blood, the agency has moved to a more targeted questionnaire about an individual's sexual history. But some advocates say that doesn't go far enough to advance equity, and those advocates include pathologist Dr. Benjamin Mazer. Dr. Mazer, welcome to the program.
BENJAMIN MAZER: Thank you so much for having me.
PFEIFFER: The FDA has been loosening its blood donation restrictions incrementally over the last decade. Could you summarize what has changed over time?
MAZER: Sure. For a long time, if you'd been a sexually active gay or bisexual man pretty much ever, you were banned for life from donating blood, which was considered extremely discriminatory and nonscientific. And then a few years ago, they changed such that you couldn't have been sexually active for the last year. And then during the pandemic amid blood shortages, they changed it to a ban of three months of sexual activity. And now it's based on whether you've had multiple partners, new partners and, in particular, anal sex recently.
PFEIFFER: Does this new requirement seem fair to you?
MAZER: It's absolutely a step in the right direction. I do want to applaud the FDA and advocacy groups for doing that. But no, it doesn't go far enough. And the intent is still to exclude non-monogamous gay and bisexual men. That is still the intent. They're trying to pick out these higher risk people and exclude them from the blood supply. And these donor questionnaires are a very crude tool for keeping the blood supply safe, and it's not the main way we keep the blood supply safe. The way we keep the blood supply safe is by testing every single blood sample for a variety of communicable diseases including HIV. And these are highly accurate tests that can catch all but the most recent infections.
PFEIFFER: And then the message needs to be - trust the science. Trust the technology. We will screen out infected blood.
MAZER: Absolutely. It's great technology. It's done universally in the U.S., and there hasn't been a transfusion-associated infection in - 2008 was the most recent one. It was a single infected donation...
PFEIFFER: Oh, really? 2008 - it's been more than a decade.
MAZER: Yes. And it's tens of millions of blood transfusions every year. And so out of - the risks of HIV are just minuscule, minuscule.
PFEIFFER: Do you think this rule change will prompt many people who used to be excluded from donating blood from now wanting to donate?
MAZER: There will be more people donating blood from the gay and bisexual community. I'm happy about that. However, now, you know, they specifically want to know how many partners you're having, how recently, what types of sex you're having. Straight or gay, not everyone's comfortable giving this information to strangers, to a medical organization, and so that's also going to discourage people from donating.
PFEIFFER: If that's the case, what do you think the FDA should do to appear to be as open and welcoming as possible?
MAZER: I recognize that the FDA is a conservative organization hoping to prevent even a single inadvertent transmission of an infectious disease. And so I think realistically, what they could do is introduce a science-based policy that uses the actual laboratory window period of the test - meaning if an infection was acquired in the last week or two. And so having some kind of questionnaire saying if you've had a new partner in the last two weeks, that may be a reasonable science-based deferral rather than the new three-month policy which isn't based on our laboratory testing. More idealistically, you might say get rid of all of these questions - that we're testing every single blood sample, and so the blood supply will remain safe even if you don't ask them. I just don't think the FDA is brave enough to do that, to be honest.
PFEIFFER: That's Baltimore-based pathologist Dr. Benjamin Mazer. Thank you very much.
MAZER: Thank you again.
PFEIFFER: We asked the FDA to respond to some of Mazer's criticisms. In a statement to NPR, the agency said its current individual risk-based questionnaire guidance will, quote, "maintain the current high level of safety of blood." The FDA noted that false negative HIV tests are rare but still possible if the donor is still in a very early stage of infection. The FDA also said, quote, "the approach to this work has always been and will continue to be based on the best available science."
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