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[00:00:00]

The number was wrong, but on Sunday, thank you very much, the Trump administration was fixated on it.

[00:00:07]

I just want to emphasize this point, because I don't want you to gloss over this this number.

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That's Health and Human Services Secretary Alex Azar.

[00:00:15]

We dream in drug development of something like a 35 percent mortality reduction.

[00:00:22]

Then there was the FDA commissioner, Steven Hahn. 35 percent improvement in survival is a pretty substantial clinical benefit.

[00:00:30]

And, of course, the president, it has proven to reduce mortality by 35 percent. It's a tremendous number.

[00:00:39]

They were talking about a treatment for covid-19 that uses something called convalescent plasma. This plasma is taken from the blood of people who have had the virus and survived. And the FDA just approved it for emergency use.

[00:00:54]

But turns out these Trump administration officials were wildly overstating the benefit of convalescent plasma. That number they used, 35 percent came from a misreading of data in one study that has not yet been peer reviewed. The actual number of mortality reduction is between three and five percentage points.

[00:01:18]

Steven, I want to thank you, because the FDA really stepped up and especially over the last few days in getting this done, coming up from plasma to testing to a vaccine more than at any point in this pandemic, scientists are afraid that politics are driving public health decisions. This is considered. This from NPR. I'm Kelly McEvers. It is Friday, August 28th.

[00:01:51]

OK, so just a little more on this convalescent plasma thing, the Trump administration appeared to have grossly exaggerated the findings of that study we talked about.

[00:02:01]

As The Washington Post put it, the administration mixed up a couple statistical concepts, absolute risk reduction and relative risk reduction. In that study, patients did benefit from plasma when the plasma had high levels of antibodies and when people were given the plasma within three days of diagnosis and when they were not on a ventilator and when they were under the age of 80.

[00:02:27]

So first thing I'd like to say is that I personally could have done a better job and should have done a better job at that press conference explaining what the data show regarding convalescent plasma.

[00:02:38]

By Tuesday, two days after that first press conference, FDA Commissioner Steven Hahn was on CBS News backtracking but still insisting the decision to announce the treatment was not political, even though a day before the announcement, President Trump had tweeted that when it came to therapeutic treatments for the virus, quote, the deep state or whoever over at the FDA is, quote, making it very difficult.

[00:03:04]

I can assure the American people that this decision was made based upon sound science and data we have shown.

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Here's the thing to remember, plasma might actually help some people. Experts say it isn't dangerous to try it. And they encourage covid-19 survivors to donate plasma if they can. But it's just not the game changer it was made out to be yet. We should also say on Friday, the day we're recording this, the FDA fired its top spokesperson who'd been on the job only 11 days and ended the contract of a public relations consultant who had worked with John.

[00:03:51]

By now, you have heard this many times, the president saying this totally untrue thing, that more testing equals more cases of coronavirus. And as we have said many times, that's just not how it works. There are states where cases have fallen even as testing rates have gone up. Still this week, something happened at the CDC that has a lot of public health officials worried that fewer people will get tested and that the decision is based on politics, not science.

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Here's what happened before Monday. The official guidance from the CDC was this testing is recommended for anyone who has been in close contact with someone who has the virus, quote, because of the potential for asymptomatic and pre symptomatic transmission this week. That language was removed and replaced with new language.

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Now, even if you have been in close contact with an infected person, the CDC says if you don't have symptoms, quote, you do not necessarily need a test unless you are a vulnerable individual or your health care provider or state or local. Public health officials recommend you take one.

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NPR's Richard Harris reports on how this change at the CDC happened, how the administration is explaining it and what public health officials think about it. There was no press release or announcement, but instead on Monday, the Centers for Disease Control and Prevention quietly updated the website that provides guidance for coronavirus testing.

[00:05:28]

The old guidelines said people who had been exposed to someone with coronavirus should get tested. The new guidelines leave that call to people's doctors and state and local public health officials. That led to widespread speculation that the guidance is intended to reduce testing.

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Admiral Bret Jervois from the White House Coronavirus Task Force told reporters that was not the intent.

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We don't expect that the volume of tests will be reduced and in fact, we do believe with some upcoming programs that the number of tests will go up significantly over the next couple of months.

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Shirwa acknowledged that the guidelines were reviewed and edited in Washington and not simply a CDC product. He said the intent is to shift testing, so it's driven more by public health officials around the country and less by individuals who want to test because they're worried but not sick.

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And in fact, the goal is to make this more strategic and intelligent by putting more power and more authority in the hands of the public health officials. That's clearly the intent, and I think it's explicit within the guidelines.

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But springing this as a surprise on public health officials has happened. Here is a poor way to accomplish that, says Dr. Georges Benjamin at the American Public Health Association.

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Nobody knows what they mean and they did not share this, as far as I know, with anybody beforehand. And so I think my good friend is spinning it a little bit.

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Benjamin agrees that there's a lot of room for improvement in who gets tested and under what circumstances.

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But he says this new directive doesn't help at the end of the day.

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This undermines the credibility of the CDC because now you've got everybody pointing fingers at one another. And that the truth of the matter is, if you want to make sure that the right people get tested with the right tests at the right time, then you need a national testing strategy that's been very thoughtful, that science based, that is in print and that everybody understands and they've not done that yet.

[00:07:19]

Another big name, Dr. Anthony Fauci, is also unhappy with the new guidelines. The most prominent member of the coronavirus task force was in surgery when the guidelines were finalized. And he told CNN he was worried that they send the wrong message. NPR's Richard Harris. So if you look at the number of cases right now, the US is basically right in between the low numbers of late May, early June, around 20000 cases a day and the high numbers of late July, 70000 cases a day.

[00:07:56]

And the number of people who are dying is following a similar trend. Not as bad as it once was, but that's about it. For nearly the entire month of August, a thousand people have died on average every day.

[00:08:12]

So then the answer to the question of how this ends is pretty much the same as it ever was. Without tighter restrictions, this virus will not go away until we have a vaccine. And now some public health experts are afraid the Trump administration might cut corners to develop a vaccine to give him an advantage in the election. NPR science correspondent Joe Palca talked about that with my colleague, Ari Shapiro. Hi, Joe. Hi, Ari.

[00:08:44]

The administration says it wants to cut through red tape to speed up the approval process. So how much red tape is there?

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Well, the job of approving a vaccine falls to the Food and Drug Administration. And, yes, there is some red tape. But but the whole reason the FDA exists is to protect the American people from unsafe and ineffective products. So at a minimum, FDA wants to see any vaccine tested in thousands of people and that any relative side effects will be found. And if the vaccine is and they want to know if the vaccine is actually preventing disease, the vaccine doesn't have to prevent 100 percent of disease to get a green light, just 50 percent would be sufficient.

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How soon can those tests be completed?

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Well, large studies are underway now involving tens of thousands of people. But you can only speed up these trials so much. For example, some of the vaccines require two doses a month apart and you can't shorten a month into two weeks. Doesn't work. So now there's a separate outside group called the Data Safety and Monitoring Board, keeping an eye on things and they see the data from the study as it comes in. Paul Offit is a vaccine developer at Children's Hospital of Philadelphia.

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He's expressed concerns that the Trump administration could try to say a vaccine is successful before the data show that. But he trusts this outside board will make sure there are no dangerous side effects from the vaccine.

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If they see strong, clear, statistically robust evidence that a vaccine is effective and they feel the trial could even be stopped early for that reason. Great. I'm all for it.

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So let's imagine they do see this evidence. What happens then? Well, normally, that would allow the manufacturer to come to the FDA and say, look, we have a working vaccine. At that point, the FDA could agree and issue something called an emergency use authorization or EOWA. But things get a little murky here because the FDA doesn't have to show the data it's using to make its decision. But in this case, the FDA commissioner, Steven Hahn, has promised that the agency would share the data.

[00:10:34]

This is what he wrote in an editorial in the medical journal JAMA.

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Transparent discussion at FDA Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy. OK, so if there is that transparency and everybody gets to see the evidence, does that mean everyone will be convinced?

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No, no, because there's always differences of opinion. It's rarely clear that something is absolutely working. You're absolutely not working, but often says the worst thing would be to authorize the use of an ineffective vaccine to try to stop the pandemic.

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Don't screw this up. This vaccine is our best way out of it at this point.

[00:11:21]

And to shake the American confidence further with either unsafe or ineffective vaccine would be, I think it says Dr. Paul Offit, who talked to NPR's Joe Palca, who was talking to my colleague Ari Shapiro. Additional reporting in this episode from our Friends at All Things Considered. For more news, download the NPR one app or listen to your local public radio station. Supporting that station makes this podcast possible. This show is produced by Briana Scott, Lee Hale and Brent Bachman.

[00:11:51]

It was edited by Sami Yenigun and Beth Donovan. Our executive producer is Cara Tallo. And this week we are saying goodbye to a really important member of our team and Lee, who has been helping produce and fact check this show since we first started back in March. She's now back at her old job with the NPR one team. And we just want to say thank you. You made every episode better.

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We're back with more next week. I'm Kelly McEvers.

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Good question. That's a really good question.

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It's a great question. This is free therapy. Thank you for asking me that. God, that's such a good question.

[00:12:27]

That's an interesting question. But what fresh air interviews are really about are the interesting answers. Listen and subscribe to Fresh Air from Why and NPR.