Consider This from NPR - BONUS: How Effective Are Antibody Treatments For COVID-19?

Episode Date: December 13, 2020

The Food and Drug Administration has issued emergency use authorizations for two monoclonal antibody treatments for COVID-19 – one produced by Eli Lilly and another by Regeneron. But emergency use authorization doesn't assure the drugs are effective.In this episode of Short Wave, NPR's daily science podcast, science correspondent Richard Harris explains how the new treatments work — and whether they could really make a difference for patients with COVID-19. Listen to more episodes of Short Wave on Apple Podcasts or Spotify.Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy

Hi, Consider This listeners, Mary Louise Kelly here. It is Sunday, which means we've got a bonus episode for you. It comes from our colleagues at NPR's daily science podcast, Shortwave. With a coronavirus vaccine still months away for most Americans, they took a look at a new therapy that could help some people who get sick with COVID-19. There's a link in our episode notes where you can subscribe to or follow Shortwave on Apple Podcasts or Spotify to hear about new discoveries and everyday mysteries and the science behind the headlines. Here is Shortwave host, Maddy Safaya. Maddy Safaya here with science correspondent Richard Harris. Hi, Richard.

Hey, Maddie. So COVID vaccines have been getting a ton of attention lately, but you're here to talk to us about a treatment for COVID that was recently authorized. That's right, last month. Another critical breakthrough in the fight against the coronavirus. The FDA cleared Regeneron's antibody treatment for emergency use, giving patients... FDA has authorized emergency use of the first antibody drug to help the immune system fight COVID-19. The drug from Eli Lilly is cleared for people... So we've got two now, one from the drug company Regeneron and one from the drug company Eli Lilly. Both Regeneron and Eli Lilly are currently testing the treatments on humans in clinical trials. They both use something called monoclonal antibodies.

In other words, antibodies that specifically target and neutralize the coronavirus. Yes, and it's important to note that this drug was approved by the FDA under what's called emergency use authorization, which means there's no real formal seal of approval that the treatment is truly effective, just that its potential benefits are likely to outweigh the potential risks. Right. And this is just one of multiple potential treatments we have for this virus at this point. That's right. And more importantly, it's a treatment option that could be in short supply, considering how rapidly the coronavirus pandemic is escalating. The federal government purchased more than a million

doses of the drugs to distribute across the U.S., and of that, around 150,000 have been delivered. And there are some other important caveats when it comes to this new treatment, from how it's administered to the potential cost for patients. So today on the show, monoclonal antibodies. We'll talk about how they work and if they'll really make a difference. I'm Maddie Safaya, and this is Shortwave from NPR. This message comes from WISE, the app for doing things in other currencies. Send, spend, or receive money internationally, and always get the real-time mid-market exchange rate with no hidden fees. Download the WISE app today or visit WISE.com. T's and C's apply.

Okay, Richard, we are talking about a treatment for COVID that people may have heard about, monoclonal antibodies. Before we get into how they work, who is this treatment meant for? The treatment is specifically for people who have recently been diagnosed with COVID-19, and they have mild to moderate symptoms. If you're sick enough to be in the hospital, these drugs won't help. Okay. Yeah. And the idea behind this treatment is to keep people out of the hospital, and the people most likely to benefit are those at highest risk for getting sick. And that includes older patients and people with underlying conditions like obesity, diabetes, immune disorders, and the like. Okay, Richard, let's get into what this treatment actually is and how it works because it's pretty cool. Naturally, our bodies produce antibodies to fight off disease.

Yes, and by and large, this works the same way. The antibodies are engineered to target the virus that causes COVID. They're brewed up in a lab and bottled up and shipped off to hospitals. Here's the idea. The antibodies are engineered to recognize and latch onto one particular part of the coronavirus. It happens to be the virus's sweet spot. And this spot is where the virus would bind to our cells in order to invade them. Right.

But if a virus is greeted by these antibodies and said it's out of luck, right, it prevents them from latching on to our cells. Exactly. It's the same general idea for a vaccine. Right. But in this case, the drug is for people who already have circulating virus in their bodies. The hope here is, of course, to stop the virus from replicating like crazy and causing a lot more damage. And Richard, this idea of using engineered antibodies as medicine isn't new. That's right. There are about 100 drugs based on monoclonal antibodies, including treatments for cancer and arthritis, to mention just a few. You know, these target tumor cells or naturally produced proteins that are causing trouble. It is a bit unusual to have a monoclonal antibody that is targeting a virus, and that's the

idea here. And because it must be given in high doses, it has to be given as an IV infusion. An IV infusion. So this is not just taking a pill or an injection. No, and that's one of the complications here, because it takes about an hour to administer the drug, say, in the hospital, and then patients have to be watched for at least an hour in case there are side effects. And so it takes like a good bit of time to actually do the treatment. And from the hospital side of things, administering this treatment has got to be a huge challenge because hospitals are already under a lot of stress around the country. You are a master of lot of stress around the country. You are a master of understatement, Maddie.

Thank you, sir, I guess. Yes. Here's the other part of it. The drug is being distributed according to where the coronavirus is running rampant. And that makes sense because that's where the most people are sick. But, you know, those areas are exactly where hospital emergency rooms and wards are already being overrun. So doctors and nurses already stretched really thin in some places have another thing that's on their plate. They may not have the staff and they may not have the space to do this other really time-consuming task. You know, Richard, I have to imagine another concern for hospitals is bringing in people for treatment who are infectious, right? I mean, the ultimate goal here is to keep them

out of the hospital. Yeah, there is some irony there. Go to the hospital to take a drug that's designed to keep you out of the hospital. But a two-hour visit sure beats having to check into a hospital and possibly ending up in intensive care. And yes, this drug is for people who are currently experiencing mild to moderate symptoms, which means they are at risk of infecting others. Certainly, hospitals want to make sure that they aren't spreading the virus to other people while they're helping these people. So how do they do that? I mean, how are hospitals managing that? Well, some have set up separate infusion centers dedicated for this purpose. I talked to Dr. Prinsy Kumar with the MedStar Hospitals in Washington, D.C. about how they're managing

to do this in the hospital while minimizing the risk to other patients. When a patient arrives, we will actually escort the patient up to the dedicated infusion center. And once the infusion is done, we will actually re-escort the patient back so the patient doesn't wander accidentally around the hospital. So even simple logistics like that needed to be worked out. And in my reporting, I also talked to an official at a hospital in Madison, Wisconsin, who told me they opened its infusion center up after hours so COVID patients don't cross paths with cancer patients. And elsewhere in Santa Fe, the hospital has a separate section of the emergency room set aside for COVID patients. And that's where they're doing the infusions in that area. Now, maybe some of this can be addressed by having the drug administered by home infusion services.

UnitedHealth Group is experimenting with that option for some of its older patients. So Richard, just hearing all of this, the cost for just administering this antibody treatment, setting aside manufacturing costs, cannot be cheap. That's right. And you know, you and I, the American taxpayers, have already purchased more than a million doses of these drugs, which cost more than $1,200 per patient. So yes, for us, the drug itself is free, or for the recipient, the drug itself is free. But administering it also costs real money, hundreds or even over $1,000 per treatment. And as best I can tell, insurance companies and the like are

still sorting out exactly who's going to end up paying for those services. And if you're a Medicare patient, you could end up with a $60 copay depending upon your plan. Okay, got it, got it. Richard, like we mentioned earlier, two of these monoclonal antibody treatments were approved last month by the FDA, but under emergency use authorization. So what do we really know about their effectiveness? Well, if you want to hear a ringing endorsement, don't turn to the experts assembled by the National Institutes of Health who evaluate COVID treatments. Their take is that at this time, there are insufficient data to recommend either for or against the use of either the Eli

Lilly or the Regeneron drugs. And by the way, the Regeneron treatment is what President Trump took, and it did not keep him out of the hospital, you may recall. Yeah. Huh. Okay. So, I mean, so what's going on with this drug, Richard? Like, throw some data at me. Well, according to the company's data, the vast majority of people fight back the virus all on their own without much, if any, help from the drug. But for a fraction, these drugs do seem to help someone clear the virus from their system a bit faster. That said, it's not clear what that means in terms of the course of their disease. And, you know, since it's impossible to know who exactly will benefit,

you really have to give this drug to like 10 or 20 people to avoid one hospitalization, according to the studies that these companies ran. Wow. So you really have to give it to a lot of people to just avoid a few hospitalizations. So I guess that leads me to ask the question, you know, are these treatments actually worth it, Richard? Well, that's somewhat an open question still, but you know, the people most likely to benefit are those at highest risk of ending up in the hospital. And remember, that's older people and those with serious underlying conditions ranging from obesity and diabetes to immune disorders. And you know, they only seem to be effective if someone is early on in their infection. Regeneron gave it to some people

after they developed their own antibodies and found that the drug actually wasn't valuable for them. I don't see it as a game changer because it's so, you know, to try to find the right patient who's early enough in their disease course and their test has come back quickly and they're at high risk of a complication and then you can get them into the clinic. You know, it's a nice hour to have for the right patient. But you're talking about, you know, a handful of patients getting it. It's not going to be the, you know, thousands or hundreds of thousands that we need to really change the game. And that's Bob Wachter, who's the chair of medicine at the University of California, San Francisco. He says what is a game changer, of course, is vaccines.

Monoclonal antibodies are nice to have and will prevent some severe cases in patients who otherwise might have been destined to get very sick. But those patients are probably going to be pretty early online for vaccines. So my hope is once we can get them vaccinated, the need for monoclonal antibodies will go down. Is that kind of where we're at, Richard? We have some OK treatments for COVID, but really, we're just banking on prevention strategies like mask wearing while kind of holding our breath until the vaccines come along? Right. But of course, Maddie, you know that's still many months away at best. Now, back in the early days, long ago, like March, people hoped there would be highly

effective drugs invented expressly to treat COVID-19. And unfortunately, we are still very far from that ideal. But that said, it is remarkable to see how much overall medical treatment has improved using old standby drugs like steroids that control inflammation and other drugs that can prevent deadly blood clots. Simple steps like getting people to lie on their stomach in the hospital also helps a lot. And these are not the kinds of innovations that send drug company stocks soaring, but they really are helping a lot of patients. And as Bob Wachter says, if the vaccines coming down the pike are as good as they appear to be at this moment, those will prevent disease in people so they won't need monoclonal antibodies or other treatments like that.

All right, Richard Harris, as always, we appreciate you. And I appreciate you. This episode was produced by Rebecca Ramirez, edited by Viet Le, and fact-checked aggressively by Ariella Zabidi. Ted Meebane was our audio engineer. Thanks to our BFF for life, Richard Harris, for his excellent reporting. I'm Maddie Safaya. Thanks for listening to Shortwave from NPR.