FDA plans to end prohibition on blood donation by gay men, with conditions

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• GWEN IFILL:

  Since the early days of the AIDS crisis, much has changed, but one ban has endured. Gay and bisexual men have not been allowed to give blood, out of fear they could transmit HIV.

  Today, the FDA announces plans to end the lifetime ban, arguing that it is outdated. Instead, the prohibition would be limited to men who have had sex with men during the previous 12 months. The American Red Cross said today it backs the change to what it called an unwarranted policy, and "strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."

  Glenn Cohen of the Harvard Law School specializes in medical ethics and he also supports the change.

  Thank you for joining us.

  Why, Professor Cohen, lift the ban now?

• I. GLENN COHEN, Harvard Law School:

  Well, the ban that we had in place was really outdated. It dates back to 1983, the early days of the HIV crisis, and a few things have changed since then.

  First of all, our ability to test and test quickly and accurately for HIV, that's dramatically improved. HIV has gone from a fatal disease to much more of a chronic disease, at least in America. And we have also had the experience of other countries. We really are an international outlier in a lifetime ban.

  Other countries have used much shorter deferral periods and we have data from those countries suggesting no adverse effects from moving to a shorter period.

• GWEN IFILL:

  Well, that's what I want to ask you, actually. Why is it that other countries move more quickly and what does that data show?

• I. GLENN COHEN:

  So the data shows — and, again, it's a mix — Canada is about five years, the U.K. is about 12-month ban, South Africa about six months, and the country that we think is the most progressive on this — and me and my co-authors in "The Journal of the American Medical Association" think this is the right way to go about it — is Italy.

  Italy has said, let's not do blanket policies. Let's do individualized risk assessments. And Italy made that move in 2001, and data published in 2013 show no appreciable increase of risk or infection rate in the Italian blood supply. So, we think this was out of date.

  FDA is a conservative institution. It's slow-moving. And this was a long time coming.

• GWEN IFILL:

  And, yet, we're not wiping out the ban or lifting the ban entirely. We're going to this one-year kind of prohibition, moratorium.

  Why? Why only go to one year? Why not wipe it out, if it's so safe, entirely?

• I. GLENN COHEN:

  So, again, I think FDA is a conservative institution. I think it wants to track what its peer countries are doing.

  My own position is that it would be much better to move to an individualized assessment, where we don't say being gay or having sex with a man is an automatic disqualifier. We again look at your individual risk level. And I'm hopeful, though, that the FDA views this as an interim step. They're relaxing the ban. They're moving it a little closer to something that is reasonable.

  And they're going to look at the data. But it's important to realize that most sexually active gay men will have had sex with someone in the past year. What this really does is bring in men who have had sex with men once since 1977.

  The current prohibition that FDA is changing says if you have ever had sex with a man even once, you're disqualified. And that's about 8.5 percent of the American male population that was disqualified originally.

• GWEN IFILL:

  Well, but now that doesn't sound like that adds a lot to the number of potential blood donors. Not only are you — you're opening the potential pool to more people, but also a very narrow subset of those people.

• I. GLENN COHEN:

  Yes, an estimate from the Williams Institute, which looked at the demography of gay men in America and also the rate of having sex and whether they're willing to donate, calculates this move will move liberate about 317,000 pints of blood a year.

  Getting rid of the ban altogether would bring in more like 615,000 pints of blood. So, it's halfway there in terms of the gains. Again, my view and the view of my co-authors is that this is too conservative, but we are hopeful that FDA has moved a little bit. It took 30 years to nudge FDA to move at all.

  And we're hoping that FDA will view this as an experiment, gather data, and then consider something a little bit more relaxed as a standard.

• GWEN IFILL:

  You said the FDA is very conservative. What is the timing on this rollout?

• I. GLENN COHEN:

  The timing of this rollout is that FDA plans, from today's press release, to issue a rule. It will have notice and comment.

  My expectation is that, in next year, we will see the policy changed effectively and all at once and at that point the Red Cross, among others, has indicated they too will change their policies.

• GWEN IFILL:

  Should Americans worry at all that our blood supply will be compromised because of this relaxed rule?

• I. GLENN COHEN:

  I think the answer is no.

  Again, the best experience and the best data we have is looking at our neighbors and to see what's happened with them. None of that data gives us any reason to worry. FDA is an extremely conservative institution when it comes to safety. Every pint of blood donated is already tested for HIV.

  All we're doing now is saying you had a classification that was overbroad, that excluded many people, and now you relax that. And the good news is that this should hopefully add to the blood supply, as well as liberate things like bone marrow and the like, which also track the blood rules.

• GWEN IFILL:

  Professor Glenn Cohen of Harvard Law School, thank you so much.

• I. GLENN COHEN:

  Thank you for having me.