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3 FDA Advisors Resign Over Approval of Alzheimer's Drug; Reuters: GA Election Workers, Their Families Receiving Death Threats; John Cywinski, President of Applebee's, Discusses Worker Shortage, Incentives for Applicants. Aired 1:30-2p ET

Aired June 11, 2021 - 13:30   ET




ANA CABRERA, CNN HOST: Welcome back.

More controversy surrounding a new Alzheimer's drug just approved by the FDA over the objections of its advisory committee.

Three members of that advisory panel have resigned in protest. They say clinical trials of this first new treatment in decades showed it was ineffective in treating the disease.

Dr. Joel Perlmutter is one of those former advisers, a neurologist at Washington University in St. Louis.

I really appreciate you taking the time today, Doctor.

Why did you resign from this committee?

DR. JOEL PERLMUTTER, NEUROLOGIST, WASHINGTON UNIVERSITY: Well, I thought this decision by the FDA was really quite egregious.

We had reviewed all of the data for clinical benefit and 10 of 11 of us thought the data did not indicate benefit, clinical benefit. One was uncertain.

Nobody thought, on this committee, that this drug had clinical benefit.

And then what happened is the FDA used what they call accelerated approval. They changed what they used as a measure of benefit. Instead of saying "clinical benefit," they thought there was benefit

to what's called a biomarker.

They did not contact us or get our advice for that. And then, they went ahead and improved -- approved the drug this past Monday.

A biomarker can be useful for determining clinical benefit if it's proven that that measure predicts clinical benefit. In this case, there was no evidence for that.

I found this decision so egregious that I resigned the day they made that announcement.

CABRERA: It's hard to understand. It's hard to really then determine why. Not one person on your advisory committee voted yes, as you just mentioned, to recommend this drug be approved.

So how do you explain the FDA's decision? Has this happened before?

PERLMUTTER: Well, this is the first time that the FDA has overwritten an advisory committee that was nearly unanimous on its decision.

They have overwritten advisory committees that have kind of been close but this is very different from that.

There's another problem with this study. And the other problem is that in the analysis that was presented to us, the original study as designed, failed completely.

Then they tried to go back and retroactively pick out a sub-group that got better.

That type of approach, statistically, is very biased, and typically does not permit -- predict what an outcome would be if one did a forward-thinking or what we call a prospective study.


PERLMUTTER: That was really a failure.

There's a lot of pressure from the Alzheimer's groups and others to bring forward a treatment. Alzheimer's disease is a terrible disease. It's incurable. So the public pressure for this is great.

But I have a major concern. And that major concern is, if we approve something that truly is not effective, and has substantial side effects, that can delay bringing forward research that can, in fact, identify a new treatment. That's the risk.

CABRERA: How does it delay?

PERLMUTTER: Two ways it may delay it. First, if people with Alzheimer's think there's already a good treatment, they may not volunteer for other studies.

New studies that go forward typically take a new drug and compare it to a placebo or an inactive drug.

In this case, if this is approved, or has been approved, now studies will have to compare to this drug. That can give you a very biased analysis of a new drug.

The second problem is not only do we have loss of enthusiasm for potential volunteers for studies, but we may have loss of enthusiasm from the NIH and other people who fund this type of research. Thinking, well, there's already something there, we don't need to move

forward. So our momentum could be diminished.

This is problematic from both perspectives. This decision may end up delaying development of treatments that may truly help people with Alzheimer's.


CABRERA: You mentioned, though, this was accelerated approval, which means that there will be ongoing studies of this particular drug.

And the FDA explained their decision saying, in part this: "Currently available therapies only treat symptoms of the disease. This treatment option is the first therapy to target and affect the underlying disease process of Alzheimer's."

"As we have learned from the fight against cancer, the lettered approval pathway can bring therapies to patients faster while spurring more research and innovation."

PERLMUTTER: Absolutely fair point. And the FDA said that they are requiring BioGen, the company, to move forward with a prospective study over the next nine years. That's incredibly slow.

And in the meantime, we may be giving this drug to people causing substantial side effects. And 20 percent to 30 percent of people given the dose of drug that's been recommended developed swelling or small hemorrhages in the brain. This is not trivial.

And so we're -- the cost of this is huge. And our efforts, I believe, would be better spent trying to either prove that this thing works, this drug, or developing a different drug that works more effectively, and safer.

CABRERA: Dr. Joel Perlmutter, thank you very much for sharing your expertise with us. I appreciate you taking the time today.

PERLMUTTER: Thank you very much.

CABRERA: Moments ago, the royals arriving for this event with the G-7 leaders. There's the queen. The prince is there, too. We're waiting for President Biden to arrive at the dinner. And so stay with us. You're watching CNN.

Meantime, harassing phone calls, emails, texts, chilling death threats. It has been months since President Biden's surprise win in Georgia. But his predecessor's big lie has election officials there still living in fear. You won't believe some of the threats they're receiving.



CABRERA: This happened just moments ago. We caught the arrival of President Biden and the first lady, Jill Biden.

They're just showing up now for this dinner, this reception, and photo-op with the royal family, along with the G-7 leaders there for the G-7 summit this weekend. Of course, they will also hold an audience with the queen on Sunday.

Meantime, it has been seven months since former President Trump lost the election.

But his big lie that it was somehow stolen continues to not only threaten America's democracy, but, also, according to a Reuters report, election officials, ranging from senior level to local levels, are increasingly becoming targets nationwide.

In Georgia, where secretary of state, Brad Raffensperger, refuted Trump's stolen-election claim, his wife, Tricia Raffensperger, says she has gotten a barrage of threatening text messages.

Including one several weeks ago that said, quote, "You and your family will be killed very slowly."

A week before that, "We plan for the death of you and your family every day."

She also got this warning that a family member was, quote, "Going to have a very unfortunate incident."

Joining us now is Linda So. She's the investigative reporter for Reuters who uncovered these troubling threats that election officials are receiving.

Linda, your reporting is chilling and uncovers yet another consequence of Trump's big election lie. Why do you think this is happening?

LINDA SO, REPORTER, REUTERS: Well, the former president continues to claim that there was massive fraud in the election.

And so Tricia Raffensperger, who is the wife of Brad Raffensperger, feels that every time something like that comes up, she becomes the target yet again.

We know that recently in Georgia, Fulton County, a judge there had called for a review of some of their ballots.

And after that happened, she received another text referring to that, where people text her really at all hours of the day and night.

She says, she gets ready for bed, she gets text messages. At 3:00 a.m. in the morning, she'll receive a text message. She'll wake up to these text messages. So, you know, they continue to be targeted.

And it's -- her recent text messages -- so people reach out to her via text. She was really the first target within the secretary of state's office.

She said she received her first text the day that the two U.S. Republican Senators in Georgia called for Brad Raffensperger to resign, calling him an embarrassment, saying the way he managed the election was an embarrassment.

She said that day is when she received her first text message.


SO: And she's been receiving them ever since.


SO: And it's not just those text messages, but frightening things have happened to not only her, but also her family. She -- of course, the Raffenspergers, they lost their eldest son three years ago. So their daughter-in-law's home was broken into.


And Tricia had explained to us that she would have her grandkids come visit her every day, once a week. It was a precious time because it was, you know, time she cherished with the grandchildren of her son who had passed away. And when she began receiving these threats, she had to cancel those visits.

So it's not only her and her family, but also her extended family. And that's really the fear that she has is that someone may act on these threats against her family members.

CABRERA: That is horrific. And it is so disturbing to read the threats that are happening to her family.

But not only her and, you know -- but many other election officials, including volunteers who are receiving numerous phone calls, threatening hateful phone calls, racist comments, I know, these actions, these phone calls, these texts.

Do we know who they are all coming from? Are they groups? Are they state actors? Who's behind it?

SO: So we know that some of the text messages that Tricia received came from bogus emails, like " People who would make up these names and send them to her.

And they've been very hard to trace because they do it anonymously.

We do know the one Web site that was created shortly after -- in December, shortly after the former president called Brad Raffensperger an enemy of the people, there was a Web site that was created targeting these various people who stood up and spoke out against Trump's false election claims.

And the FBI has been able to trace that back to Iran.

But some are just anonymous threats where people -- we just don't know who's sending them.

CABRERA: I wish we had more time to discuss because your reporting is so thorough and there's so many layers to it.

Linda So, thank you for giving us a glimpse into what you've learned. We appreciate it.

We'll be right back.



CABRERA: OK, we've told you about the worker shortage. We've told you how businesses are rolling out all kinds of incentives to lure applicants.

Applebee's is using a different tactic, apps for apps. Apply for a job, attend an in-person interview, get a free appetizer. And apparently, tens of thousands of people did.

Applebee's president, John Cywinski, is joining us now.

First, thanks for being with us.

Help us understand just how big is your worker shortage and what is your biggest need right now?

JOHN CYWINSKI, PRESIDENT, APPLEBEE'S: The labor shortage is real, Ana. It's been persistent in the spring.

I think probably compounded by kids at school in their homes, creating some challenges for parents. That impacts certainly the restaurant business.

We executed the National Hiring Day at Applebee's, hoping to get 10,000 applications. We received more than 40,000 in one day, which exceeded our expectations.

It was a great day, something you can expect us to do again.

CABRERA: So did you get --

CYWINSKI: And the positions, Ana, servers, bartenders, kitchen cooks, dishwashers, to-go specialists. Those are the positions that are important to us.

CABRERA: Are you all good? You don't need any more applicants? You got 40,000 for 10,000 jobs. You're ready to go?

CYWINSKI: No, that's an ongoing effort. You know, I expect -- this is very much a bit of a point this time subject.

I would expect by the time we get to September that the labor challenges we're seeing across the country will be mitigated when kids go back to school.

Of the 40,000 applications, we had 10,000 interviews, we hired more than 5,000. And we'll continue to do so over the next couple of months.

CABRERA: So obviously, this campaign did work, the free vouchers for appetizers. You're giving away free food here.

But why not take that money and invest it in workers, raise wages? I remember working as a waitress in college. It's hard working and so many restaurant workers are barely making ends meet.

CYWINSKI: I'll tell you, our franchisers, who own and operate virtually all of our restaurants, have a terrific culture, take care of their teams.

One of the big insights, Ana, I've seen, kind of seen on a post- pandemic basis, Americans are hungry to dine out. March and April were two of the best months we've had in our 40-year history.

But the big insight I leave you with is I think Americans are so thankful to be dining out, they're really generous with their tips. That's one of the big insights.

They're indulging when they come out. They're very thankful for those servers and bartenders --


CYWINSKI: -- many of them know them by name. That's just the nature of --


CABRERA: No, that's wonderful to hear people are generous when they come to dine in your restaurants. But I don't think you answered my question. Why not raise wages?

CYWINSKI: Our franchisees have very healthy wages for everything from our general managers to our hourly associates. They provide also referral bonuses, retention bonuses.

And now with businesses at record-setting levels, those tips and those wages are commensurate with that. So we're in very good shape.

Our team members, they're not here for the short haul. We have team member that have been here for decades with Applebee's. It's a very strong culture with very long-tenured team members.

And they find this very attractive so we're very pleased.


CABRERA: May I ask how much a server or a host or a busser or cook makes at Applebee's?

CYWINSKI: Well, that's all contingent upon -- the servers, contingent upon tips. It's not uncommon --

(CROSSTALK) CABRERA: Which are not reliable.

CYWINSKI: Very reliable at the moment. Certainly, you can find servers who earn well north of $25, $30 an hour just based upon tips. And that's very common across the system.

So we are -- I think it's quite evident, we have big demand for Applebee's. We treat our team members very well.

And the 40,000 applications we received on May 17th wildly exceeded our expectations. We'll probably do that again that in June.

CABRERA: I really appreciate your taking the time and sharing some of what you're experiencing with us. Good luck as you continue to work to hire people.

Thanks for being with us, John Cywinski.

CYWINSKI: Thank you. Appreciate it.

CABRERA: And thank you all for joining me today. I'll see you back here next week at 1:00 Eastern. In the meantime, don't forget to follow me on Twitter, @AnaCabrera.

The news follows next with Alisyn and Victor. Have a great weekend.