DAVID GREENE, HOST:
The Trump administration has cleared the way for convalescent plasma to be used to treat more COVID-19 patients. We're talking about using blood plasma from other people, people who've recovered from a coronavirus infection. Thousands of patients have already been treated this way, but the FDA's emergency use authorization increases access. And let's begin our discussion of this with NPR's Allison Aubrey, who's here this morning. Hi, Allison.
ALLISON AUBREY, BYLINE: Good morning, David.
GREENE: Can you just give us the basics here? What exactly is convalescent plasma, and has it been effective so far?
AUBREY: Sure. Convalescent plasma is based on the idea that antibodies from people who have recovered from COVID-19 can help protect people who are currently sick with the virus. So plasma is taken from recovered people and transfused into patients who are hospitalized, battling the virus. Now, all of the experts I've spoken to say this is not a magic bullet. It's one more therapy that could be helpful.
Now, there's been concern that there's not enough evidence to show how effective it is. There are more studies underway now. And the thinking among administration officials seems to be this - look; it's safe. It looks promising, especially if people are treated early. Let hospitals keep using it. It was used at Mount Sinai in New York during the early months of the pandemic and at Houston Methodist. Doctors have more tools in their toolkit now, I'd say. There's remdesivir, steroids. So plasma could be thought of as sort of one more tool to try.
GREENE: Well, Allison, stay with us if you can. I want to come back to you.
GREENE: For the moment, I want to turn to one expert who's on the line with us. She's also someone who's been closely involved in decisions about whether to approve medical treatments. Dr. Margaret Hamburg was the commissioner of the Food and Drug Administration for six years during the Obama administration. Dr. Hamburg, welcome.
MARGARET HAMBURG: Thank you very much.
GREENE: So as Allison described it, it sounds like this could be one more tool in the toolkit. Let's start with the therapy itself. I mean, how much potential, how much promise do you see here in terms of saving lives?
HAMBURG: Well, it has promise. We know that convalescent plasma has been used to treat patients for decades, really. But what we don't know is how it works in this case. Is it truly effective? When in the course of disease might it be most effective and for which patients? And that's very important information when we want to provide the best care to patients. And, in fact, the data collected so far really does not ask and answer that set of critical questions because it hasn't been done. The right studies that are controlled haven't been done as of yet.
GREENE: Yeah. I mean, you've actually called the FDA's decision here disturbing. Why are you so worried about it?
HAMBURG: Well, you know, first of all, it did not seem necessary at this time, and that there really is access to convalescent plasma that's quite widespread under an existing expanded access program. More than 66,000 people have received it. What's desperately needed now, in my view, is to really do the right study so that we can ask and answer the questions about, does it really work for whom and when in the course of disease? We really can best serve patients with that information.
But what also worries me is the way that all of this unfolded, the way it was framed, you know, the increasing politicization of the FDA process. And this is a critical time for the public to have confidence in the FDA that it is making evidence-based, science-driven decisions about things that really matter for health.
GREENE: I mean, you could look at this in a bunch of different ways. I mean, some have noted this decision comes as the Republican convention is just starting, which some have said is - might - they might think there could be politics involved. But I also wonder, I mean, this is a desperate moment, right? We're in a pandemic. We have, like, a thousand Americans dying on some days. Isn't the bar lower to approve something like this and get it approved as quickly as possible?
HAMBURG: Well, what happened with the emergency use authorization, first of all, is not an approval. It is something that in a public health crisis like the one we're experiencing enables FDA to put out a product in a more urgent way, looking at all of the available data and making the decision about whether the apparent benefits outweigh risks. And, you know, in that context, offering an EUA for this product, I think, you know, can be supported.
The larger question, though, is that even in a public health crisis like COVID-19, we really want to be able to do what's best for patients and individuals at risk. And that means actually studying the issues to know what works so that we can offer patients the best therapies and treatments possible. And right now, with convalescent plasma, we actually don't know what the answer is. It probably has some marginal benefit. It's probably not much. But in order for doctors and patients to make the best decisions about care, we need more information. And I hope this will not interfere with the ability to do some ongoing clinical studies to get those answers.
GREENE: I want to ask you one related question about vaccines. Obviously, we're all waiting for that moment. The Financial Times is reporting that the Trump administration might be thinking about fast-tracking an experimental coronavirus vaccine from the U.K. What do you think of that?
HAMBURG: Well, we are moving very, very swiftly in trying to develop a whole set of vaccines to potentially protect against coronavirus infection. I think we need to move forward as swiftly as we can, do everything we can to make vaccines that work and are safe, available to people. I can't comment on that specific issue. But I do think that we need to move as effectively and efficiently as possible but without cutting corners when it comes to making sure that we know whether the vaccine actually works and whether it's safe to give to the people who need it.
GREENE: Former FDA Commissioner Dr. Margaret Hamburg. Thanks so much for your time this morning.
HAMBURG: Thank you.
GREENE: And NPR's Allison Aubrey is still here. Allison, I wonder if we could broaden out the conversation a little bit and look at this pandemic...
GREENE: ...As a whole. We've got new cases declining in the U.S. That sounds good. But it's still circulating widely, a lot of questions now about keeping students safe if schools decide to reopen in person. So like, where are we here?
AUBREY: Sure. I mean, big picture, as you say, new cases are declining over the last week or so. There's been about 44,000 new cases per day - so still a lot. But that's a significant decline compared to a month ago. There are still a lot of people dying, as we've been saying - about a thousand deaths a day. That's about 40 people every hour. Hospitalizations have begun to decline, so that's encouraging. But given that the virus is still circulating widely, it's a reminder to stay vigilant since we don't yet have a vaccine or a cure-all.
GREENE: I mean, as we just heard Dr. Hamburg talking about, like, I mean, everyone wants to get a vaccine. I mean...
GREENE: ...Out there as quickly as possible. But there are concerns about doing it safely. The president is saying that he's not happy with the pace of vaccine research. Can you talk about what we're hearing from him?
AUBREY: Sure. I mean, over the weekend, the president tweeted a theory that doesn't seem to match the facts. He said the FDA is making it difficult for drug companies to get people into vaccine trials, suggesting that there were political motivations at the agency to slow the process and delay until after the election. But you know, former FDA Commissioner Scott Gottlieb said on CBS, this just does not fit with reality. He says the agency is guided by science, by its public health mission. And he says the process to test a vaccine is moving ahead very quickly.
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SCOTT GOTTLIEB: The vaccine trials have enrolled very fast. Moderna and Pfizer, the two U.S. manufacturers who are the furthest ahead, enrolled 25,000 patients into those trials in the four weeks that those trials have been stood up. And they've really only been enrolling in earnest for three weeks. That's extraordinary. So to say that these products aren't moving at a really historic pace, I think, is wrong.
AUBREY: And remember - Gottlieb led the FDA early in the Trump administration. So you know, many public health experts just wince at the idea of politics getting in the way or the suggestion that the administration could fast-track the process.
GREENE: Allison, let me ask you about something else. We have these moments when, you know, health officials are saying, this is how you avoid spreading the virus - for example, avoid large crowds. And then we see these images on the news and on social media of people in large crowds. And we're seeing them coming...
AUBREY: Right (laughter).
GREENE: ...From college campuses right now...
GREENE: ...I mean, these parties with students in big groups, no masks. How worrisome is this?
AUBREY: Yes, lots of images on social media. You know, campuses are cracking down on parties and big gatherings. Schools know that if they get it wrong in these first few days or weeks, it's going to be hard - almost impossible - to prevent or control outbreaks. And we've seen this play out at Chapel Hill, at Notre Dame, where in-person classes were suspended. And then when you think about the kindergarten to high schoolers, you know, the evidence is clear, David, that children get the virus. They can spread the virus, especially older kids. So it's important to protect at-risk teachers and students.
The CDC director, Robert Redfield, has said it is possible to open safely if there are precautions in place. He points to evidence from Rhode Island, where, he says, the state successfully opened daycare centers. Now, the daycares did identify infected people, but they quarantined them. And that helped prevent spread to the community. Now, in order to do this effectively, you have to identify people who are infected quickly. You need testing, preferably rapid testing, to get this done.
GREENE: NPR's Allison Aubrey for us this morning.
Allison, thank you, as always.
AUBREY: Thank you, David.
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