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News Brief: Delta Variant, Upcoming Vaping Decision, Elizabeth Holmes Trial

NOEL KING, HOST:

President Biden will talk to the country today about a course correction.

RACHEL MARTIN, HOST:

Yeah. He's expected to unveil a new strategy to fight the delta variant of the coronavirus that has put so many unvaccinated people at risk. The plan comes after a series of setbacks and possible missteps in the administration's battle against COVID.

KING: NPR health correspondent Rob Stein has some of the details of what we're expecting today. Hey, Rob.

ROB STEIN, BYLINE: Good morning, Noel.

KING: What do we know about the president's plan?

STEIN: The White House describes it as a six-pronged strategy that will involve both the government and the private sector. No details yet, but a source familiar with the announcement tells NPR it'll involve new steps aimed at vaccinating the unvaccinated and furthering protection for people who are vaccinated. The president will also address ways to keep schools open safely, increase testing and require masks, as well as protect the economy and improve care for people with COVID-19. You know, I've talked to some public health experts who hope the administration will finally take some more aggressive actions like, you know, mandating vaccines for travel and get behind some kind of uniform national vaccination verification system.

KING: Six prongs sounds like an attempt to reset after this period in which we're watching cases rise. We're watching deaths rise.

STEIN: Right, right. You know, I've been hearing kind of a growing sense of disappointment and frustration. The administration gets really high marks for a lot, especially for quickly ramping up the massive vaccination campaign and getting tens of millions of people vaccinated. But then the vaccination campaign lost steam, and the administration's response started to stumble, like back in May, when the CDC abruptly dropped the recommendation that everyone keep masking. That kind of sent a message that the pandemic was over. And the country pretty much cut loose. I talked about this with Dr. Leana Wen, a public health professor at George Washington University.

LEANA WEN: It is directly as a result of the CDC's actions back in May and the Biden administration's lack of leadership that we have the surge that we're seeing now. What let delta gain a foothold? It was because of people's actions that were directly enabled by the Biden administration's response.

STEIN: You know, and now we're seeing hospitals around the country being overwhelmed.

KING: Confusion about masks - hospitals are overwhelmed. And there's also a lot of questions around whether people need boosters or not.

STEIN: Right, right. You know, first, no need for boosters, then everyone's going to get a booster on September 20.

KING: Yeah.

STEIN: Then maybe you won't have to wait eight months after your second shot for your booster. Now, well, maybe only people who got the Pfizer vaccine will get boosters to start. So, you know, there's a lot of concern that the administration is sending head-spinning messages that raise doubts about how well the vaccines work and whether the White House is really letting the FDA and CDC lead the way like they promised. I talked about this with Dr. Celine Gounder at New York University. She advised the administration during the transition.

CELINE GOUNDER: It should not be a political decision. It should be coming down through the scientific and regulatory agencies. To assume that they would agree or rubberstamp such a plan, I think, is just wrong.

STEIN: And there are other concerns. You know, why is testing still so hard to get? Why is the U.S. relying on Israeli and British data to make crucial decisions? Why's the CDC not tracking and analyzing all the vaccinated people with breakthrough infections way more closely? Here's Dr. Ezekiel Emanuel at the University of Pennsylvania. He's another former Biden adviser.

EZEKIEL EMANUEL: The CDC has not done the job it should do for monitoring genetic variants as well as breakthrough. I mean, May, we stopped recording breakthrough infections systematically. That's not a good place to be.

STEIN: So people hope the administration's new plan will help get the country back on track. But they're worried, you know, especially because of the unrelenting resistance to masks from so many Republican governors and widespread misinformation about the vaccines.

KING: NPR health correspondent Rob Stein. Thank you, Rob.

STEIN: You bet, Noel.

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KING: All right. The problem with e-cigarettes is that while they were aimed at adults trying to quit regular cigarettes, in fact, they became very popular with kids.

MARTIN: So the FDA blocked the sale of many of the flavored vaping products. Since then, the agency's been weighing whether e-cigarettes, the benefit of them to adults outweighs the risks to kids. And today we expect to hear whether more vape products will be banned.

KING: NPR's Allison Aubrey has been following this one. Good morning, Allison.

ALLISON AUBREY, BYLINE: Good morning, Noel.

KING: What exactly is the FDA in the process of deciding?

AUBREY: Sure. Well, I mean, many people know the brand name Juul, but there are other - hundreds of other companies that market e-cigarette products, and many teenagers and young adults continue to use them. Companies have known for a while that the FDA was in the process of reviewing their products to determine if they could remain on the market. But this process was going pretty slowly, so advocacy groups sued the FDA. Bottom line - the court gave the FDA one year to make some decisions. That one year is up as of today. Here's Matt Myers, the president of the Campaign for Tobacco-Free Kids.

MATT MYERS: Today FDA is required to look at each product to determine whether the continued marketing of that product will continue to put kids at risk.

AUBREY: ...And whether the product can help adult smokers quit. But Myers points to a 2020 surgeon general report that concludes there's just not enough evidence to make a determination.

KING: So this is really a story about unintended consequences. The justification...

AUBREY: Yeah.

KING: ...For e-cigarettes is that they're supposedly less harmful, they might help people quit. But now the concern is that they're, in fact, luring young people to nicotine.

AUBREY: That's exactly right. And once young people start, it's hard to stop because nicotine, whether it's in a cigarette or a vape stick, is very addictive. The e-cigarette maker Juul says it is trying to combat underage usage. The company says it's focused on harm reduction for adult smokers. Now, data shows sales have been ticking up again, and Matt Myers argues now is the time for the FDA to take decisive action.

MYERS: Over 80% of kids who use e-cigarettes use flavored products. Eliminating those products would be the most significant thing you could do to reverse the youth e-cigarette epidemic.

AUBREY: He says he would also like to see the FDA remove products that deliver much higher levels of nicotine compared to cigarettes.

MARTIN: Right. Some of the flavors are things like cotton candy. They seem directly designed to appeal to kids. So do you think it's possible that the FDA could take some products off the market, but just leave others there?

AUBREY: Yeah. The agency is likely to continue to crack down on the flavored products. They've already denied applications for companies that market flavors such as apple crumble and cinnamon toast crunch, clearly designed to appeal to kids. But it is unclear what the agency will do about menthol, which is very popular. Juul markets a menthol product, and many health organizations have asked the FDA to reject Juul's application. Here's Erika Sward of the American Lung Association.

ERIKA SWARD: We would oppose any Juul product remaining on the market. The history and their actions are clear that they're interested in addicting a new generation. And no Juul product, whether it be tobacco flavored or menthol flavored, should be allowed to remain on the market.

AUBREY: Now, the FDA could announce its decision anytime now.

KING: OK. NPR's Allison Aubrey. Thank you, Allison.

AUBREY: Thank you, Noel.

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KING: At the start of her trial yesterday, prosecutors described Elizabeth Holmes as a villain motivated by greed.

MARTIN: Holmes is the founder of Theranos. This is a biotech company that promised a blood test that would transform the industry. Holmes stands accused of defrauding investors of millions of dollars and deceiving patients. She, though, maintains her innocence.

KING: NPR's Bobby Allyn was in the courtroom yesterday. Good morning, Bobby.

BOBBY ALLYN, BYLINE: Good morning.

KING: Tell me about Elizabeth Holmes' defense.

ALLYN: Yeah. In opening statements, her defense team said being a startup CEO is a tough job. You know, Holmes was working 12 hours a day, seven days a week. She thought of herself as kind of this visionary, and she founded a company when she was 19 years old as a Stanford dropout and hustled for 15 years to grow Theranos into a $9 billion company before it imploded.

Now, when it comes to the fraud she's accused of, her defense lawyers did some wide-ranging finger-pointing. They said the No. 2 at the company, Sunny Balwani, had more oversight than she did over some of the more dubious parts of the company and that laboratory managers, not her, were ultimately responsible for the company's blood testing, which was exposed to be flawed and sometimes just downright inaccurate.

One of the defense lawyers, Lance Wade, said, quote, "Ms. Holmes made mistakes, but mistakes are not crimes. A failed business does not make a CEO a criminal."

KING: OK. That's the defense. And what does the prosecution say?

ALLYN: Yeah, they zeroed in on a moment when Theranos was burning cash and on the verge of bankruptcy. Prosecutors said Holmes got really desperate. They said she forged a fake report from Pfizer that made it look like the drug company approved of Theranos, written even on Pfizer letterhead, when, in fact, Pfizer had said the exact opposite. Holmes then used this document to raise lots of money and get lots of glowing media coverage. Meanwhile, prosecutors say Holmes' underlying technology, these blood analyzers, they were a total myth. Prosecutor Robert Leach told the jury that Holmes lied and cheated to get money and, quote, "It's a crime on Main Street, and it's a crime in Silicon Valley."

KING: Why does this trial feel like it is bigger than Elizabeth Holmes, even though it is very much about Elizabeth Holmes?

ALLYN: Yeah, that's right. Look; you know, millionaires are minted all the time in Silicon Valley. And you know, many of these people are chasing that kind of money to tell a story about themselves, about a product, you know, something trying to change the world for the better. But that can put them at odds with regulators and the law. And a lot of people out here in Silicon Valley, you know, think it's OK to sort of push against boundaries. And Elizabeth Holmes was doing this in her own way. But prosecutors said the key difference here is that she broke the law in the process. Traditionally, you know, the norm in Silicon Valley is to sort of move fast and break things. That's a motto you hear a lot around here. But you know, maybe depending on how this trial turns out - if the jury, you know, returns a verdict that says that Elizabeth Holmes is guilty, then maybe it will temper some of that behavior.

KING: Could be interesting, yeah. How long's the trial going to last? Any idea?

ALLYN: Yeah, the judge says we should expect a three-month trial. So a parade of witnesses - Theranos whistleblowers, experts, patients and even perhaps Holmes herself - will be taking the stand to testify. At the end of the year, the jury should start deliberating over Holmes' guilt or innocence. And if convicted, she faces up to two decades behind bars.

KING: NPR's Bobby Allyn in Silicon Valley. Thank you, Bobby.

ALLYN: Thanks so much. Transcript provided by NPR, Copyright NPR.