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NIH Warns Data On Effectiveness Of Convalescent Plasma In Treating COVID-19 Is Weak

AILSA CHANG, HOST:

There's a COVID-19 treatment that many physicians think is promising, but the Food and Drug Administration has not yet given it special status. Joining us to discuss what the treatment is and why there might be some hesitation about it is NPR science correspondent Joe Palca. Hey, Joe.

JOE PALCA, BYLINE: Hi, Ailsa. How are you?

CHANG: Good. All right, so what exactly is this treatment that we're talking about here?

PALCA: Well, we're talking about something called convalescent plasma, and it comes from patients who get COVID-19 and then get better. So think about it like this - let's say you got sick and you felt terrible for a while but then you got all better. Well, presumably, in your blood, there are some antibodies that help you get better. Now, let's say I get sick. Well, if I'm given your blood into me - some of it anyway - those antibodies, presumably, would help me get better. And it's an approach that's been used for a while, and it's often used in pandemics before there's anything better.

CHANG: Fascinating. So why does the FDA appear to be hesitating?

PALCA: Well, I mean, the FDA doesn't usually give any kind of hint about what they're thinking until they publish a result. But The New York Times reported today that some officials at the National Institutes of Health, who are advising FDA, didn't think there was strong enough evidence that convalescent plasma actually keeps people from dying. There's good evidence that giving someone the plasma doesn't make them worse, but what the NIH folks appear to be concerned about is whether it actually helps keep them alive. Now, Arturo Casadevall of Johns Hopkins Bloomberg School of Public Health has been one of the champions of convalescent plasma, and he agrees there isn't the kind of study, you know, the randomized controlled clinical trial that's gold standard that would prove that convalescent plasma helps people survive when they're hospitalized. But that's not to say the approach is a flop.

ARTURO CASADEVALL: There has been no data that say the plasma is not working. In fact, all the information that we have is very encouraging.

PALCA: Casadevall says there is now data from about 30,000 patients indicating that the treatment does seem to be helpful somewhat.

CHANG: Well, then, where does all of this leave patients? I mean, can they still get access to this treatment?

PALCA: Yes. Casadevall says even if the FDA doesn't grant what's called an emergency use authorization that makes it easier for doctors to provide convalescent plasma to their patients...

CASADEVALL: It doesn't change the fact that, you know, a patient in United States will continue to have it available.

PALCA: That's because the treatment is available under what's called an expanded access program, which requires more paperwork and approvals, but it can be given to patients. And, you know, a lot of patients are getting this. The Mayo Clinic is running a lot of patients and subjects in a program to study this. And I just looked at the Mayo website, and there are now 66,735 people who've been treated with this convalescent plasma. So that's quite a few.

CHANG: Wow. But, I mean, I imagine that logistically it could be really hard to collect and then distribute all of this plasma, right?

PALCA: Oh, yes, you're right. It's a big logistical lift, and it involves a lot of people, and it involves patients going and having their blood drawn and spun down and bag the plasma and send it to where it's gone and make sure it's not got any other diseases in it. So it's complicated. But as I said, it's something you can use until something better comes along.

CHANG: OK. So real quick, putting this aside, is there anything better coming down the pipeline?

PALCA: Well, yeah, in fact, there is, or there appears to be. I mean, this idea that there are antibodies in the blood that could help someone get better is prompting people to build what they call synthetic antibodies or monoclonal antibodies. And there are a lot of studies that are beginning that will test whether these synthetic antibodies, which are purified and concentrated, will work just as well or work better.

CHANG: That is NPR's Joe Palca. Thank you, Joe.

PALCA: You're welcome. Transcript provided by NPR, Copyright NPR.

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