HHS Chief Alex Azar Defends Authorization Of Plasma To Treat COVID-19

Aug 24, 2020
Originally published on August 24, 2020 7:41 pm

The Food and Drug Administration has given the green light to expand the use of blood plasma in treating hospitalized COVID-19 patients.

The emergency use authorization announced Sunday involves convalescent plasma — taking antibodies from the blood of people who have recovered from COVID-19. That plasma is then given to patients currently sick in hopes that the antibodies will help fight off the disease.

It's unclear how effective the treatment is (more background on that here).

The announcement Sunday came after President Trump accused the FDA and "deep state" of stalling the authorization to hurt his reelection chances. The FDA says its decisions are based on science, not politics.

Health and Human Services Secretary Alex Azar talked with NPR's Ari Shapiro on All Things Considered about the authorization. The FDA is an agency within HHS. Here are excerpts:

Let me ask whether you believe, as the president asserts, that the "deep state, or whoever, over at the FDA" is intentionally delaying access to vaccines and therapeutics until after the election.

Well, what the president is getting at is his demand that we get rid of any unnecessary bureaucratic red tape, that we recognize that this is an unprecedented pandemic, that people are suffering, that lives are at risk and is insisting that we move as quickly as possible. But at the same time, we also are ensuring that the FDA will hold therapeutics and vaccines to the data, evidence, scientific and regulatory standards that they have to ensure that products are meeting the safety and efficacy standards that are set.

Accusing the FDA of intentionally delaying this because of political motivations until after the election is a little bit different. And I just want to know if you support that assertion.

I'm not going to get into that. What we have is really a historic achievement here, a historic milestone, which is authorizing convalescent plasma for emergency use. Plasma has been around for 118 years and its use: It was used in the 1918 flu it's used for SARS, for MERS.

But thanks to President Trump's leadership, we actually have generated data and evidence here to support authorizing it for emergency use. And what the data showed was that in individuals under the age of 80 who were not on mechanical respiration and who were administered higher-titer doses within the first three days of hospitalization, a statistically significant impact. Now we're going to keep studying plasma in randomized controlled clinical trials against placebo as we keep generating data.

But 70,000 individuals were administered convalescent plasma, some of whom had no antibodies in the titer or low titers of antibodies, some who had high. And the they saw through the analysis a clear dose response that supports the emergency use authorization here.

I do want to ask you, though, about the timeline, because it's striking that the National Institutes of Health last week expressed concern about the limited evidence of the effectiveness and asked the FDA to delay the approval. Then the day after the tweet from the president, the FDA issued this emergency use authorization. Does the president risk undercutting public trust in treatments and vaccines when he makes these accusations of politicization and then the FDA immediately changes course?

First, the factual premises there are not accurate. The NIH would, of course, like to see randomized controlled clinical trials against placebo. And those are ongoing. But working together, we analyzed a significant data set coming out of the 70,000 patients who've had the convalescent plasma. The authorization coming from that analysis was already on track as of the end of the week. The rollout materials were being prepared and the authorization was coming out on Sunday already.

Listen to the full interview at the audio link above.

NPR's Jonaki Mehta and Becky Sullivan produced and edited the audio interview.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

ARI SHAPIRO, HOST:

After President Trump criticized the Food and Drug Administration over the weekend, the FDA took action. First, the president accused a so-called deep state at the agency of intentionally slowing approval for COVID-19 treatments and vaccines until after the election. Then the FDA issued an emergency use authorization for a treatment called convalescent plasma. That's where the plasma of someone who has already recovered from the disease is given to someone who's currently fighting it. Alex Azar is the secretary of Health and Human Services, which includes the FDA, and he joins us now.

Welcome to ALL THINGS CONSIDERED.

ALEX AZAR: Ari, it's great to be with you. Thank you.

SHAPIRO: First, let me ask whether you believe, as the president asserts, that, quote, "the deep state" or whoever over at the FDA is intentionally delaying access to vaccines and therapeutics until after the election.

AZAR: Well, what the president's getting at is his demand that we get rid of any unnecessary bureaucratic red tape, that we recognize that this is an unprecedented pandemic, that people are suffering, that lives are at risk and is insisting that we move as quickly as possible. But at the same time, we also are ensuring that the FDA will hold therapeutics and vaccines to the data, evidence, scientific and regulatory standards that they have to ensure that products are meeting the safety and efficacy standards that are set.

SHAPIRO: Getting rid of bureaucratic red tape and moving quickly seem like consensus positions that anyone would agree to. Accusing the FDA of intentionally delaying this because of political motivations until after the election is a little bit different. And I just want to know if you support that assertion.

AZAR: Well, I'm not going to get into that. What we have is really a historic achievement here, a historic milestone, which is authorizing convalescent plasma for emergency use. You know, plasma's been around for 118 years in its use. It was used in the 1918 flu. It was used for SARS, for MERS. But thanks to President Trump's leadership, we actually have generated data and evidence here to support authorizing it for emergency use.

And what the data showed was that in individuals under the age of 80 who were not on mechanical respiration and who were administered higher-titer doses within the first three days of hospitalization - a statistically significant impact. Now, we're going to keep studying plasma in randomized, controlled clinical trials against placebo as we keep generating data. But 70,000 individuals were administered convalescent plasma, some of whom had no antibodies in the titer or low titers of antibodies, some who had high. And they saw through the analysis a clear dose response that supports the emergency use authorization here. We think this is a very important...

SHAPIRO: I do want to ask you, though, about the timeline because it's striking that the National Institutes of Health last week expressed concern about the limited evidence of the effectiveness and asked the FDA to delay the approval. Then the day after the tweet from the president, the FDA issued this emergency use authorization. Does the president risk undercutting public trust in treatments and vaccines when he makes these accusations of politicization and then the FDA immediately changes course?

AZAR: Well, Ari, it's - first, the factual premises there are not accurate. The NIH would, of course, like to see randomized, controlled clinical trials against placebo, and those are ongoing. But working together, we analyzed a significant dataset coming out of the 70,000 patients who've had the convalescent plasma. The authorization coming from that analysis was already on track. As of the end of the week, the rollout materials were being prepared, and the authorization was coming out on Sunday already.

SHAPIRO: I just want to be clear about the numbers here. The preliminary data showed that plasma reduces mortality by about three percentage points, from 11% to 8%. This was a preliminary study which may or may not hold up. I just wonder whether the president risks undercutting public trust in treatments and vaccines when he makes these kinds of accusations about people in the deep state acting based on politics.

AZAR: Well, Ari, you know, the way you phrased that there - I think it's actually - it's important to emphasize this is a 35% mortality reduction from...

SHAPIRO: From 11% to 8% - right. Yeah.

AZAR: That's a 35% reduction. In the world of drug development, in terms of mortality benefit, that is a very significant impact. Now, we will keep working to confirm that through additional clinical trials. But this is precisely why we have emergency use authorizations that the FDA has authority to do - is to make these types of potentially life-saving treatments available. And I encourage individuals who have recovered from COVID to go to coronavirus.gov. To find out how they can donate, contact their American Red Cross or their local blood bank. You literally could save a life. As many as three individuals can benefit from one person donating plasma. And I ask people to please consider donating.

SHAPIRO: If I may end on a slightly different note, the New York Times is reporting that you conditioned federal relief funds to hospitals in hard-hit areas on their participation in reporting pandemic data to a private company rather than the CDC, which has been the tradition. Hospitals are complaining that this new system is slower and gives less access to data than the old CDC system. Are you planning to reverse course on this?

AZAR: No. Ari, we need data in real time. The old CDC system was a system built for antibiotic resistance drug tracking, not for a pandemic emergency response. We could not get daily hospitalization information of COVID admissions, of remdesivir utilization and remdesivir supplies and stock of personal protective equipment or ICU utilization. And it would have taken close to a month to reengineer that computer system to do that. We used a private vendor that enabled us to make immediate changes to gather that type of information. I would think you would want, as I do, real-time, daily information. We now are - we were getting 50% of hospitals complying. We now have over 95% compliance by hospitals with that type of information that's fundamental to a response.

SHAPIRO: Thank you, Health and Human Services Secretary Alex Azar. We appreciate you talking with us.

AZAR: Thank you. Transcript provided by NPR, Copyright NPR.