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Brian Lehrer: Brian Lehrer on WNYC. Now that COVID vaccines are getting into people's arms, what about treatments? Last year, the FDA granted Emergency Use Authorization for a class of antiviral medications known as remdesivir. You've heard of that, in hospitalized COVID patients. Now Emergency Use Authorizations can allow physicians the benefits of novel treatment options right away, like remdesivir and those antibody cocktails, but as my next guest writes, they can also hinder clinical trials, the gold standard for developing new drugs and vaccines.

So now a year into the pandemic, there remains a lack of COVID treatments, and a lack of research really into cost-effective COVID-19 therapies. How can policymakers rectify the situation? From a research perspective, how much ground is there to make up? In what ways have COVID-19 treatments improved over the course of the past year, even as they've taken a backseat to vaccine research? Joining me now is Dr. Kevin Tracey, MD, President, and CEO of the Feinstein Institute for Medical Research. That's part of Northwell Health. Dr. Tracey, thanks for coming on. Welcome to WNYC.

Kevin Tracey: Thank you. Nice to be here, Brian.

Brian: I see that in the opinion piece for the industry magazine called The Scientist. A couple of months ago, you and your colleague, Dr. Christina Brennan, argue that Emergency Use Authorizations have hindered clinical trial research. You want to lay that out for us?

Kevin: Sure. During a pandemic, when there's insufficient knowledge by caregivers as to how to treat a patient, Emergency Use Authorizations have an incredibly important role. It allows physicians and caregivers on the frontline to make best decisions with the best available information they have in order to try to save lives, and that's what we've just lived through.

What we have at the end of the day now a year later, Brian, is we have one FDA-approved drug for the treatment of COVID. That's only in patients who are hospitalized very, very sick. Today, a year later, if you are sick with COVID at home, the CDC guidelines and I'm reading from the website are; stay home, take care of yourself, get rest, take acetaminophen, it may help you feel better, and get in touch with your doctor.

Brian: Which is like nothing.

Kevin: What does that say?

Brian: Nothing.

Kevin: It's nothing. We do not have the data today, a year later for what to do for the patient in the community who's maybe diagnosed with COVID and doesn't know what to do next, and there's no guidance because we don't have enough data. We have no data from randomized controlled trials about what would be potentially effective, generic, broadly available safe drugs that may or may not be beneficial in the early stages of COVID.

Brian: Wait, the vaccines that so many people are getting and clamoring for are also approved under the same category, "Emergency Use Authorization." President Biden yesterday said, "There'll be enough vaccine for every American by the end of May." Why does an Emergency Use Authorization that is rolling it out into actual use so quickly hamper vaccine development if it's hampering treatment development?

Kevin: I think that the rolling out of the vaccine, especially in the timescale with-- That occurred so quickly, is a historic accomplishment for the human race. It is a victory for science against the virus that was threatening civilization as we know it. Not enough good things can be said about the development of the vaccine, but the vaccine has been authorized under Emergency Use Authorization because the data indicates it's beneficial and reduces mortality rates. In nursing homes, where the vaccines have been widely distributed, the mortality rates have plummeted. In countries like Israel, where the vaccines have been widely distributed, the mortality rates have plummeted.

The data are pretty good because of the large numbers of people that have been enrolled in these observational trials, albeit without controls, without proper placebo controls, but they are large numbers of observational studies that suggest that vaccines are safe and effective, and I would urge everyone to get the first available vaccine that's offered to them. Brian, even after the vaccines, there will be a treatment gap because for a number of obvious reasons. First, some people will just refuse to get the vaccine, and that's obviously a much longer conversation.

Second, the vaccines may not be available to all communities and all countries at the same rate. Third, some people probably a small number may still get COVID even after they've been vaccinated. I think that's a small number. I think the other two instances are much more serious problems. My point is this, there will be a gap that will hit hard, the underrepresented minorities and the underserved communities because we don't have treatments when they get sick. Until they get very sick, and then they're in the hospital and we have remdesivir.

Brian: Listeners, if you have a question about COVID-19 treatments, we can take those questions now for Dr. Kevin Tracey, CEO of the Feinstein Institutes for Medical Research. That's the science arm of Northwell Health. 646-435-7280, 646-435-7280. Let me ask you about another particular one that's been in the news. We know that President Trump when he got COVID got this and that's those monoclonal or polyclonal, people use both words, which are the opposite of each other. Monoclonal polyclonal antibodies.

I know somebody who's a doctor, and her 90 something-year-old mother got COVID recently, and this doctor daughter went into action and got her mother the monoclonal polyclonal antibody treatments right away because I gather you're supposed to get it in the first week for that treatment to be effective. She feels like she saved her mother's life. Her COVID resolve pretty uneventfully. How much does that story represent something that everybody who gets COVID, or their 90 something-year-old mother gets COVID should clamor to do?

Kevin: I think the story rings true. I think there's a very good chance that the monoclonal antibody, if not saving her life, helped her have a much less severe case of the disease. The use of these antibodies is very important. At Northwell Health, we've given many, many, many hundreds, if not thousands of doses of these antibodies to patients.

We're in the process, my colleagues of putting together the data for publication, and what we've observed with the use of these antibodies. These antibodies, like the vaccine, are a very important step in the treatment of COVID. Brian, I don't think these antibodies will be available to all communities equally. They require intravenous administration, they're expensive. The access of a monoclonal antibody infusion while important, and quite likely effective in many, many patients, is not the same as knowing whether we might be able to treat patients in their home with generic drugs that may also be effective but have not been studied.

Brian: Talk about that equity issue with the antibodies a little more because true the family I know is fairly comfortable white family. How do we get for the moment, the antibody treatment to be more available across the board with equity in mind?

Kevin: Brian, it's a great question. In the opening intro, you framed questions for policymakers, and I think this should be top of list. How will the treatment of COVID be done equitably across communities with or without access to expensive intravenous medications? Right now, we don't have enough data to answer a simple question. There's a shortlist of generic drugs, Brian, that have been proposed as possibly beneficial in the treatment of early COVID.

In no particular order, you've heard of some of this famotidine which is an antacid, it's a generic anti-acid, which is also sold under a brand name Pepcid dexamethasone which can be taken as an outpatient. Ivermectin, which is an anti-parasitic drug. Statins were implicated as possible treatments earlier this week, and colchicine which is a gout drug, and even vitamin D. Now, I'm not advocating the use of these and from my reading of the news, President Trump was given I think most of those.

However, as a scientist, I'm trying to raise the question of why haven't these drugs been studied in outpatients? People are not requiring hospitalization because they're cheap, they're generally safe, they're widely available, and what if they worked? What if they actually prevented the progression of the disease and kept people home, and kept them out of the hospital, what difference would that make? It would be huge.

Brian: You're calling on the Biden administration to organize a therapeutic review board to help identify more clearly what's working and what's not.

Kevin Tracy: The Biden administration has set up ACTIVE, which is a program administered by the NIH, which has made an important contribution to prioritizing these kinds of questions. As of today, on the website anyways, all of the drugs that are being run through that program are like monoclonal antibodies. They're expensive intravenous drugs. None of the agents I just mentioned to you, which you can buy in any local drugstore pretty much, are on that list.

They're not being studied in any coordinated way, nationally. Absolutely, Brian, I think we need a national effort to determine the strategy, to share data, and to pull together groups to do these studies. We've been studying famotidine here for the last year, and every time we get to the point where we're enrolling patients, another EUA is issued, and it becomes almost impossible to enroll the patient in a trial.

Brian: Emergency Use Authorization, so the clinical trial ends. Do you think this is politics? Do you think the politics of developing vaccines has been so overwhelming that there just isn't the political impetus to throw money and effort at treatments in the same way?

Kevin Tracy: It's not just politics in my opinion. My colleague, Derek Angus, in Pittsburgh wrote a commentary this week in the JAMA Network, which I urge anyone interested to look at because it really lays out the complexity of this. The comparison, Brian, is really to at the UK, where they have a centralized body that oversees, not only the clinical care programs in the hospitals and clinics in the United Kingdom, but also overseas, how research is done.

There's a central body in place to coordinate the needs of the caregivers, which during a pandemic are overwhelming. I don't want to oversimplify this. When people are wearing PPE and consents are being given over a tablet or a phone, and people are at death's door and don't know what to do. It was a horrible time and many are still suffering from the horrors of COVID. It is also a time, a year later to develop a strategy going forward because this will happen again.

There will be another pandemic, and we need to figure out how to get answers to clinical treatment questions, not just for hospitalized patients, but for people walking around going to their local doctor who may or may not have access to all the monoclonal antibodies.

Brian: This is WNYC-FM HD NAM New York, WNJT-FM 88.1 Trenton, WNJP 88.5, Sussex, WNJY 89.3, Netcong, and WNJO 90.3, Toms River. We are New York and New Jersey public radio and we're going to take some phone calls now for Dr. Kevin Tracy Tracy, President, and CEO of the Feinstein Institutes for Medical Research, the science arm of Northwell Health as we focus on COVID treatments, not vaccines for this segment.

Nurses, doctors, healthcare workers on the frontlines, how have you seen COVID treatment evolve? What are you doing now that you weren't doing 10 or 11 months ago, or anybody with a question about COVID treatments, or a story? Bhatia in Brooklyn, you're on WNYC. Hi, Bhatia.

Bhatia: Hi, can you hear me?

Brian: Sure can. Loud and clear.

Bhatia: Sadly, my father just died on January 10th-

Brian: I'm so sorry.

Bhatia: -of COVID. At that point, I traveled out to see him, he was at home. He was told to take aspirin and to get a pulse oximeter. If his pulse went below 90 to take him in. In the meantime, he's 81 years old. He was having all different types of symptoms, ones that I didn't even realize were symptoms and I'm not a nurse. Finally, his pulse went below 90, pulse ox went below 90. We took him in, and then we never got to see him again.

In the meantime, my mom got sick because they were in the same house. She got the monoclonal antibody because her doctor went and got it for her. She never had one symptom and she has type 2 diabetes and goes to dialysis three times a week. I feel like the medical world failed my father because they didn't take care of him and have him come in to see if he had viral pneumonia or whatever it might be sooner than later, and it is a tragedy.

Brian: It is a tragedy.

Bhatia: I know I'm not alone in this, but I just had to call and say that there's so many differing ways that people are treating this and telling people what to do. My mom had a proactive doctor, and my dad had someone who didn't know what the hell he was doing. It's just really sad. I just want to tell everybody, how sorry I am for all of their losses, and appreciate you doctor for being here. I'll take my answer offline because I've got to go.

Brian: Bhatia, thank you very much. I appreciate how difficult that was for you, and to re-traumatize yourself over that for the sake of helping other people avoid the unnecessary loss that you feel that you've endured. Doctor, does that story ring true?

Kevin Tracy: 100%. There's no fault to be given here other than I would take it as a national challenge because you can multiply that storytimes thousands of people, in thousands of communities with differing access to these drugs that are probably effective. It sounds very much like the monoclonal antibody saved her mother's life. Thank goodness for that. Thank goodness we have those drugs.

What about other treatments that may have been available for other patients not getting, or her dad not getting the monoclonal antibody? We have to do the work, we have to set up the clinical trials, we have to coordinate the data from those trials. We have to inspire the physicians in the community, and the patients in the community to participate in these trials. We have to say, “We don't know what to do.” If you're home with COVID, and not sick enough to be in the hospital, which is what it was with her dad. The doctors have to say, “I don't know.”

If the answer is, “I don't know,” then we have to come together as a physician and science community and set up the trials. If we can't get enough patients, as we've had a difficult time doing in the community around Northwell for the last three months to do outpatient trials, then we need to bring large health systems together and do it in multiple centers and in multiple sites. Brian, if I may, that really brings up another important point.

Brian: Go ahead.

Kevin Tracy: We can't sit back and say, “Oh, the pharmaceutical industry is going to solve this.” They're not. These drugs I'm talking about cost pennies. The Pharma industry operates on profit, as it should. That's what industries and for-profit companies do, but this is a different problem. The problem we have here is there's no motive. There's no financial motive to test some of these drugs in the outpatient setting. Absent a financial motive, we need a national motive.

Brian: Viviana in Manhattan, you're on WNYC. Hi, Viviana.

Viviana: Hi, everyone. Thank you for taking my call. I was sent home two days ago with a oxygen tank. I had COVID. I got COVID a week-and-a-half ago. All I can think of this time is like while I-- The moment I get sick, I got my fever. I should have called my doctor, and maybe they found out a way to get this antibody because when I got to the hospital a week later, I was out of oxygen after calling an ambulance three times and nobody would pick me in because their numbers were in 9089

They gave me dexamethasone, but remdesivir interacted with my liver. They had to stop that. Now, I have COVID pneumonia. While I was there when I was crazy fever, trying to contact my doctors individually, even my PCP wasn't-- She was like, “I don't know what to do.” You know a PCP, at this point a year later-

Brian: Primary Care Physician.

Viviana: -I could call in sick and know what to do.

Brian: Doesn't even know, a year later.

Viviana: I contacted my GI doctor, she said, “Well, I'll contact the other group of female GIs and see what they think about your liver.” Then, I was released without any guidelines like, “Do I need to continue to test after? When I'm able to walk out of my house, how do I know I'm not contagious somebody else?” Right now I'm locking my doors, having everything delivered. I get it, but I will need to get some more testing done. Will they take my test? Will I have to walk somewhere where I'm going to be contagious other people? That's my--

Brian: Right. It sounds like you're not getting enough guidance on that. Dr. Tracey, can you help Viviana at all as an individual here?

Kevin: No, I can't sadly. I'm not able to offer treatment, of course, for a specific patient like this, nor for the previous caller, but I do think that the questions are real and you are not alone in this. You are suffering through a disease that has just had its first birthday. What's not being talked about very much is we still know very little about this disease.

For everything that we've learned about the disease, we're still learning more every day. What I'm concerned about is that we need to be developing the research protocols, the studies. There should be a study available for you that you could go to and participate in, and maybe get the benefit of an experimental drug in that study. Even if you were not getting specific benefit from a drug in the study, by participating in the study, you could be helping thousands or millions of other people and your suffering would not go in vain.

Brian: Viviana, I hope that's at least a little bit helpful. What has been the most successful intervention because I think many fewer people who even get hospitalized with COVID are dying of COVID at this point than a year ago. Like I've heard about how something as simple as positioning non intubated patients on their stomachs can aid them in recovery, as opposed to on their backs, and reduce the need for ventilators. What has worked because the death rate has come down, right?

Kevin: It's still uncertain whether the death rate has actually come down. That is possible, but that will take many more months of combing through data to really understand did the death rate come down, or did the virus change? In one community, is the virus less lethal than another because it's a different virus or a different mutation? The answer is not certain that the death rate has come down. When you look at large populations, it still seems like the death rates on the order of 15% or 20% for people who are critical-- Once you get critically ill.

You are right, it appears for the less critically ill patients that major treatment advances have actually been exactly the kinds of things you were saying, Brian, so ventilating prone, keeping people on their stomachs rather than their backs, delaying ventilation, not putting people on a ventilator right away. Some very sophisticated changes in the settings of the ventilator machine, how the oxygen is being delivered. Anticoagulation, keeping the blood thin has been very important, and the control of fluid monitoring has been important.

It seems as if dexamethasone, once people become very sick in the hospital, dexamethasone is probably effective and has probably saved a lot of lives. Remdesivir, according to the current EUA is recommended. As we talked about before, monoclonal antibodies are also under EUA recommended, but the only FDA-approved drug for hospitalized COVID patients today is remdesivir.

Brian: We just have two minutes left. Let me sneak in one other caller on something in the headlines this morning, COVID-related. Jimmy in the Bronx, you're on WNYC. Hi, Jimmy. We've got about 20 seconds for you.

Jimmy: Hello. Can you hear me?

Brian: Yes.

Jimmy: Okay. The question is, Texas Governor, how can the doctor community, the physician community, call this guy out and say no. None accountability. Call him out and say, "You're crazy, you're a fool. You opening up your system with no mask requirement. You're freeing people from a system that actually does work, less dying." The community is allowing just the media or anybody else to do the normal stuff like, "Okay, we'll write him off. We'll say nice things, bad things. Bottom right?" But nobody's actually sitting there saying like with a match through town saying, "No, you're a nut."

Brian: Jimmy, I have to keep you short today-

Jimmy: I'm done.

Brian: -but please call us again. Do you have any thought from a clinical perspective, Dr. Tracey? For people who haven't heard the story, the governor of Texas, Mississippi also, but Texas is so big and includes all these major cities, is now completely opening up the state, 100% of the restrictions on businesses, capacity requirements, or anything else have been lifted. Businesses can do whatever they want, and no more mask mandate in Texas. Are the clinical implications for this that you're thinking about at Northwell Health?

Kevin: I think there will be clinical implications. Look, at Northwell Health, our mass care providers who were treating patients with COVID for months at a time, the people who wore masks and PPE had the same infection rate as those in the community. What does that mean? That means that the PPE works. That means that you can be exposed to COVID and not get it if you're wearing a mask and protected.

To those people who want to go to a crowded place and not wear a mask, I would go at your own risk. I urge all my friends and family, the ones that listen to me anyway, to wear their masks for that reason. The masks work.

Brian: I'm sure there are huge equity implications from that policy too. I'm thinking about the politics of who's out there demanding reopenings and who gets COVID but listen as we're going to dive into that on tomorrow's show more deeply.

Kevin: Brian, imagine that the people who get infected because of those implications you just pointed to in the underserved communities also show up at the doctor as what your previous caller did and the doctor doesn't know what to do. We haven't tested generic available drugs that may actually work. It's time to act.

Brian: Dr. Kevin Tracey, President, and CEO of the Feinstein Institute for Medical Research, the science arm of Northwell Health, calling from the top down, from President Biden down, a more concerted effort to study and develop COVID treatments. Thanks for coming on with us. I think it's been important.

Kevin: Thank you.

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