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Episode 107
Duration 33:32
Stephanie Sudikoff

Stephanie Sudikoff: The Power of Medical Simulation

Howie and Harlan are joined by Stephanie Sudikoff, an expert on using simulation to train healthcare professionals, to discuss her new venture working to expand treatment for neonatal jaundice and how simulating procedures can assist in quality control and ongoing training. They also look at new developments in AI in radiology and the economics of a powerful treatment for inflammation.

Links:

AI and Radiology

“Imaging AI hogs the spotlight at RSNA, with debuts from GE, Siemens, Philips”

“Accuracy of ChatGPT, Google Bard, and Microsoft Bing for Simplifying Radiology Reports”

“Characterizing the Clinical Adoption of Medical AI Devices through U.S. Insurance Claims”

“Kim Kardashian Got a Full Body Scan, Why Medical Experts are Concerned”

“Design goal: Photon Counting CT engineered with Deep Silicon technology to enable advanced CT Imaging”

Heart Flow: Revolutionizing Precision Heart Care

Neonatal Jaundice and Medical Simulation

Little Sparrows Technologies: Big Ideas for Little Babies

Stephanie Sudikoff: “Variability in quality of chest compressions provided during simulated cardiac arrest across nine pediatric institutions”

“‘The Damar Effect’—the nationwide backorder on a lifesaving machine and the 620% increase in CPR”

Stephanie Sudikoff: “An Approach to Confederate Training Within the Context of Simulation-Based Research”

"Assessing the quality of primary healthcare in seven Chinese provinces with unannounced standardised patients: protocol of a cross-sectional survey"

The Economics of Dupixent

“Sanofi, Regeneron say Dupixent succeeds in another late-stage COPD study, setting up filing for FDA approval”

“With new trial data, a blockbuster therapy from Sanofi, Regeneron could find an even bigger market”

“A Drug for Itchy Dogs Costs $1,200. Why Is the Human Equivalent $43,000?”

“Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts”

Regeneron: “Dupixent ® (Dupilumab) significantly reduced COPD exacerbations in second trial”

“HHS Selects the First Drugs for Medicare Drug Price Negotiation”

Learn more about the MBA for Executives program at Yale SOM.

Email Howie and Harlan comments or questions.

Transcript

Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. We’re excited to welcome Dr. Stephanie Sudikoff today. But first we like to check in on current hot topics in health and healthcare. So what do you got for us today, Harlan?

Harlan Krumholz: Well, Howie, I’ve got something here that I think you can teach me. So we’re at that time of year where they have that extravaganza for all the radiologists in the country.

Howard Forman: Oh my God, it is insane. Have you ever been?

Harlan Krumholz: No, I haven’t been there. They migrate to Chicago for some big conference in McCormick [Place]. Uh-huh.

Howard Forman: That’s right. It’s enormous. It’s sixty or seventy thousand people. It’s almost the same size as the climate conference in Doha this weekend.

Harlan Krumholz: Oh my goodness. So a lot came out of this conference around AI. And as you know, that’s a real interest of mine. And so I just wanted to get your sense of what’s going on in radiology. I was just going to highlight a few things that I read about. So GE Healthcare is spotlighting AI-powered systems across all of its imaging and talking about automating routine tasks and focusing on the root causes of burnout. I mean, what was interesting to me was a lot of the headlines were about how they want to make life easier for radiologists—not necessarily how they’re going to save lives, not necessarily how they’re going to improve patient care, but how they’re going to address burnout.

I guess that’s because the customers largely are the radiologists. Siemens came out, I’ll just list off a couple. Siemens came out and really also talked about how they’re going to use generative AI, these large language models to combine the imaging scans with clinical reports. And again, make it easier for radiologists, address this issue of burnout. And so I was looking at all this stuff, and I was just wondering, what’s your experience of it as a radiologist? I mean, do you see real change? Do you feel a difference in your clinical work every day now because of all the AI that’s coming out?

Howard Forman: So some of it I already do. And I don’t know if you want to call it AI, but we’ve had assistive technologies in radiology for a long time. We’ve used templates as cardiologists, to have with your echo reports [echocardiography reports], as you know, we’ve used things like that. But when they start to auto-populate, when they start to make it a little easier to be able to translate a finding in the body into the impression, it can make things a lot quicker.

But I do think what you said is absolutely right, and it’s disturbing to me how much this caters to the radiologist as opposed to the end consumer who’s paying for the radiology studies. But I guess that is the marketplace that we have right now. And what they don’t want to be saying is that we’re going to be able to make things so productive that you won’t even need so many radiologists. Nobody wants to hear that. But in reality, that’s a big part of it as well. It is interesting. Just last week, we came out with a paper in radiology that was led by Kanhai Amin, an undergraduate at Yale and a former student, and Melissa Davis, who you know, who’s been on the podcast.

Harlan Krumholz: Yeah, she’s great.

Howard Forman: And a couple of others, looking at how well large language models can take an impression from a radiology report and translate it to a level so that a patient can understand it.

Harlan Krumholz: I’m guessing it does it really well.

Howard Forman: It does it pretty damn well. I mean, it can’t get it down to an eighth-grade level, but that’s probably because most of medicine is hard to reduce to an eighth-grade level, but it can reduce it to a level that becomes understandable. And more importantly, what we showed in that paper is all the major platforms we tested for are accurate. They don’t misinterpret things. Like we worried about hallucinations, we worried about, are they going to make things up or remove important things? They didn’t do that. We had two experienced radiologists review every impression compared with the ChatGPT and all the other platforms, [Google] Bard and so on, and looked at how well they did, and they were very accurate. So Sophie Chheang, who’s in our Department of Radiology, is working on a company that will automatically, as you’re writing your report, will automatically take the report and create the impression, and then it’s just one extra step to take the impression and translate it for the patient.

Harlan Krumholz: But I don’t see what the barrier is going to be for this, what they so-called “moat” is for a company like that. I mean, everyone’s going to be able to do that, and I’ll be very interested to see how she does.

Look, I’ve got a couple more things for you. Let me bounce through these. So another thing was that, out of the meeting, something came out that I hadn’t heard of before, and it’s a CT that’s photon counting. I didn’t know what that meant, but it seemed like it was an innovation. What is that?

Howard Forman: So up until now, most of radiology is based on voxels and pixels, basically volume elements of human tissue, and then how many beams of light make it through, basically, or X-rays make it through. And so we look at things as being white or black or somewhere in between, and we can measure that. But it’s not really quantitative. It’s not telling you exactly how many photons are associated with it.

Harlan Krumholz: And so, do you mean by that is that we get a cross-sectional impression of it, but we’re not really appreciating how big something is, or is that—

Howard Forman: The quantitative nature of it. I think that the issue here is that we’re getting closer and closer to, like you talked about, when we had, I think it was Rohan Khera, talked about EKGs and how there’s so much more information there than we actually see on the tracing. I think this is the analogy to that.

Harlan Krumholz: Yeah. And are you enthusiastic about it?

Howard Forman: We’ve seen things in the last few years that I never would’ve believed, Harlan. For instance, we can now take a contrast-enhanced image and create a non-contrast-enhanced image without having to re-radiate the patient. We used to do a non-contrast CT followed by a contrast CT to look at what changed. We now can scan them once, and just using technology, figure out what the non-contrast would’ve looked like. We can do things that were seemingly impossible 10 years ago just with the current existing technologies. But Harlan, you and I, we need to have a conversation about this movement again, to whole body scanning. I don’t know if you’ve noticed that.

Harlan Krumholz: Yeah, the Kardashian scans. The Kardashian scans.

Howard Forman: Oh my god, this concerns me. And yet, when I read about them uncritically in the media, I’m concerned that it sounds too good to be true.

Harlan Krumholz: Yeah. Well, I mean, it all seems like we want people to, why don’t we get scans every week just to make sure nothing’s coming up? But as we’re discussing it, it can lead us to identify things which cause a lot of other tests, even biopsies that aren’t needed and so forth.

Howard Forman: And it can give us a false sense of security. Like, “Oh, I got nothing, and I’ve treated my body badly for the last 50 years, so I guess it doesn’t hurt me.”

Harlan Krumholz: Well, I’m going to try one more on you, and then we can get onto our guest. And then, by the way, next week, I want talk a little bit about the reimbursement for these things, because as these innovations come up, as all this AI comes up, there’s a natural issue about, “Well, who’s going to pay for this, and how’s it going to work?”

But here’s another one. There was an article that came out in The New England Journal—A.I. A.I. is so hot that The New England Journal of Medicine, one of the leading journals in the world, decided to spawn a daughter journal called New England Journal of Medicine AI. In this, there was an article that was looking at these CPT codes, the codes that are used for the billing of many of these new AI techniques. And in the end, by the way, of all the ones, and that’s why I want to dig in deeper maybe next week, of all the new things that have come out, only a small handful have actually gotten codes associated with them so that people can bill for them.

But when you look at the ones that did get the codes, there are very few claims for most of them, except the one that was really at the top was this one for looking at coronary artery disease, a heart flow analysis. And this really perplexed me because there’s a company, came out of Stanford, that said, “We can take the information from a CT scan that’s focusing on the coronary arteries, and we can actually infer the flow down these arteries.” Not just show it anatomically but be able to show information that gives you a sense of whether or not the flow is impeded. But it’s like a $5,000 test. And I was surprised when I ordered a CT scan, CT angiography here at Yale—

Howard Forman: I remember that. Yeah.

Harlan Krumholz: ...and it was just added on. I mean, no one even asked me. And I inquired about it and they said, “Well, yeah, we think it gives more information.” But by the way, this hasn’t been shown to save lives, although the company promotes the information as being actionable. And what do you think about this?

Howard Forman: Yeah, we need to have a longer conversation about that because on the one hand, you do want to be able to innovate. On the other hand, once Medicare says something is codable and billable, it’s almost impossible to stop doing it. And you and I, for 28 years of knowing each other, we’ve talked about how many things Medicare allows to happen that has no value or maybe even is harmful. And we have a responsibility to be able to figure this out because it’s taxpayer dollars going for it. It is a bigger conversation.

Harlan Krumholz: And I think, just finally on this, that what we’re saying is that, oftentimes, there’s a lot of scrutiny on therapeutics. But diagnostics also deserve that same kind of evidence. It’s harder to generate around outcomes because you get information and then people act on the information. But increasingly, as we get more and more of this kind of information, and information linked to therapeutics also, it’s going to be so important for us to generate the evidence.

Howard Forman: Yeah, I agree. A lot to think about.

Harlan Krumholz: Yeah. So we’ve got lots more to talk about in future episodes. So let’s get to our guest, Howie.

Howard Forman: Stephanie Sudikoff is an associate clinical professor of pediatrics in the Pediatric Critical Care division of the Yale School of Medicine’s Department of Pediatrics. Previously, she served as executive director of the Simulation at Yale New Haven: Advancing Patient Safety and Education’s Center for Learning Transformation Innovation, also called SYN:APSE. There, she oversaw and helped develop curricula for medical students, residents, and other healthcare professionals by using simulation techniques. She’s now the chief medical officer at Little Sparrows Technologies, a neonatal care company specializing in innovation and phototherapy.

Dr. Sudikoff’s work is focused on patient safety and simulation to investigate healthcare quality, inpatient outcomes. She educates and consults healthcare providers on systems design and operational best practices and has year-long coaching and teaching experience. She was the president of the International Pediatric Simulation Society as well as vice chair of the Global Network for Simulation and Healthcare, among other respected positions. She has a BA from Columbia, an MD from Mount Sinai, and a master’s of healthcare administration from the University of New Haven.

So first, I want to just welcome you to the Health & Veritas podcast. You’re trained as a pediatric intensivist. You’ve worked and continue to work with children in critical care settings. But now you’re in a startup company that is looking to treat neonates with jaundice. And a lot of mothers, new mothers in particular, find themselves facing neonatal jaundice, and they don’t know what to think of it. And I just want to start off by framing this for people about why hyperbilirubinemia or jaundice or kernicterus, what do those words mean? Why should we care?

Stephanie Sudikoff: So first, I just want to say thank you to both of you for having me. It’s a pleasure to be here. Hyperbilirubinemia means that the amount of bilirubin rises in the baby’s blood. Bilirubin is a breakdown product that is made when red cells are broken down. While the baby is still in the mother’s uterus, the placenta is responsible for eliminating that. And obviously, once the baby is born and the placenta is no longer a resource for them, their liver needs to pick up the slack and start doing that work on its own. And there are times when it may not be quite up to the task and able to eliminate the bilirubin fast enough. And at that point, the levels will rise.

Howard Forman: And why do we worry about that? Why do we care?

Stephanie Sudikoff: Yeah, so kernicterus, you mentioned that earlier, kernicterus is a form of brain damage that occurs when that elevated bilirubin goes untreated and can lead to severe impairments including deafness, cerebral palsy, movement disorders, and is almost entirely preventable if the baby is treated in a timely manner.

Howard Forman: And so just briefly, and then I’ll turn it over to Harlan. Can you explain the role of phototherapy in managing hyperbilirubinemia, and how do we know whether we need to use it or not? I’ve known a lot of mothers who have said to me, “The bilirubin is high, and we don’t know if we have to go back into the hospital.”

Stephanie Sudikoff: So let me just start by giving a little context in terms of the scope of this issue. So 140 million babies are born each year around the globe, and 3.7 or so million babies are born in the United States on an annual basis. 10% of those babies will require phototherapy, so that’s a lot of babies. The treatment is fairly simple. It’s the use of blue light. It’s a very specific wavelength of light, and you expose the baby’s skin to that light, and it causes the bilirubin to change its chemical configuration, and makes it dissolvable in water or in blood so that it’s much more easily excreted from the body.

Harlan Krumholz: There still remains, sometimes, patient safety issues, where people are overlooked. And the easy availability of this and the kind of treatment means that actually there should be no one who’s missed. And so, what niche are you filling with this company? What’s the unmet need?

Stephanie Sudikoff: The company itself was founded by a Yale-trained pediatrician who happened to be a resident with me, one year ahead of me, and a Harvard-trained neonatologist. And really, the concept evolved for her when she was in the newborn intensive care unit, taking care of babies who were being treated for jaundice, and there were a few at a time.

And looking at the way it was most currently done, she realized there was a real gap in the market, and there was an opportunity to do things more efficiently in a much more baby- and family-friendly way, and in a way that did not cost as much. That was where the concept began. I will also say that a big piece of the inspiration for the creation of the device, which is called a bili-hut, was the notion that it would be scalable to be used on a global level.

I think, in the United States, phototherapy seems like a pretty straightforward treatment. However, that is definitely not the case around the globe. And recently, we were at the American Academy of Pediatrics meeting in Washington, D.C., and we had pediatrician after pediatrician from Latin America, Central America, the Philippines—really, all over the globe—coming to talk to us because they were trying to find resources that they could make much more easily accessible to their patients who required this therapy.

Harlan Krumholz: But I also want to take advantage of your expertise as an international expert in simulation. Simulation is so interesting to me. I still don’t think we use it enough. And it can be both a tool for training, but also for the assessment of quality. And I want to dig into one thing first around this was, of course, as a cardiologist, I’m naturally interested in the work that you were doing on cardiopulmonary resuscitation and your use of simulation as a means to assess the quality of chest compressions that were provided during sessions like this, and being able to go across nine institutions and sort of seeing what that kind of variability is. I wonder if you could just speak to that a little bit. What was that study, and why was it so important that you showed this variation, and what should we be doing about it?

Stephanie Sudikoff: Yeah, thanks for asking, Harlan. CPR is such an essential skill set, and I think people take for granted that they know how to do it. We all get trained early in our careers. We may periodically have to get retrained, but the level of detail and the focus of attention on the quality of chest compressions is what makes or breaks the resuscitation.

Harlan Krumholz: And importantly, this study, and what you’re talking about right now is about health professionals. So this isn’t about laypeople getting trained, but this is us. This is ... right? Right? I mean—

Stephanie Sudikoff: Yeah, it’s get with the guidelines. It’s the American Heart Association’s big campaign now, is you need to be doing these chest compressions well. And the ability to measure your effectiveness with a mannequin that can tell you whether you’re doing it correctly or not, there are devices that can be put on the chest that may give you some immediate feedback. But also, having someone who is part of that resuscitation team, whose job it is to watch the chest compressions and make sure that they are being done properly and effectively.

Harlan Krumholz: And you found this vast variation among the sites, right? I mean, it’s just true that everyone’s not doing it the same.

Stephanie Sudikoff: That’s 100% true. It’s very dependent on just the position of your arms. If your elbows are not straight, if your arms are bent, you’re not going to be as effective. When you think about the situation in which these resuscitations take place, it’s a room full of chaos, no matter how hard you try. And so, people’s adrenaline is surging, they’re not necessarily completely focused on the task at hand. And so, focus and attention on depth and rate is an essential piece.

Harlan Krumholz: But in this study, you were finding important differences. I mean, some people were doing it ineffectively.

Stephanie Sudikoff: 100% correct.

Harlan Krumholz: Yeah. So, I mean, just again, health professionals, so Howie, this is an area where ... and that’s why I think Stephanie’s work is so important here, to say, we can’t get complacent about the very basic thing of saving a life with these kinds of compressions or to think it’s easy. And by the way, on the Damar Hamlin thing, it’s not natural just because they call a CO, just because there’s people that show up, that they’re going to be able to save a life. In that case, those were highly trained people who effectively maintained his circulation until they restored, this is the guy who passed out at a football game between the Bengals and the Buffalo Bills. And he made a complete recovery because the CPR was done in such a timely way and so effectively. So anyway, I thought this was really important work that you’ve done.

Stephanie Sudikoff: And particularly in pediatrics. Thankfully, cardiac arrest is not as common an occurrence in the pediatric world as it may be on the adult medicine floors. And so pediatricians have even fewer opportunities to practice those skills.

Harlan Krumholz: But I would just guess it’s harder because you’ve got to accommodate for what is the size of the kid. So your chest compressions, you’re not just learning a standard chest compression, but you’ve got to be able to think, “Is this a baby? Is it an adolescent? Is it a toddler? What is it?” All these would be different, I would suppose.

Stephanie Sudikoff: They are. Yeah, there’s no one-size-fits-all for us. We have to treat the people from 5 pounds to 500 pounds. But you’re absolutely right, there are different depths of compression for different age groups.

Harlan Krumholz: Another important piece that you put out that I thought it was very thought-provoking was the use of actors, you called them “confederates.” People who were being put into the position where they’re working with the people who are doing the training and trying to help the trainee. So you’re actually using not just the mannequins, but you’re actually using ... I usually call them actors when we’re using them in simulation, but you used this “confederate” term. I think we should be doing this a lot more.

There was a study in China that in which they took actors showing up in clinic, making regular appointments, providing a story, a series of symptoms that were supposed to lead the clinician down a certain path. They were acting like they had a certain disease and seeing how common it was for the people to detect it. And I think we should be doing that a lot more, both within the context of a simulation but also in the context of our real-world experience, where we don’t know that that person’s doing it as a way to get feedback. And again, we have to get past the shame of not always getting 100% score on everything we’re tested on and using it as a way to hone our skills and to be able to be more reproducibly excellent with every patient we see. But what do you think about expanding this? Shouldn’t this be something we should be doing more of?

Stephanie Sudikoff: Of course it should. You’re asking a biased party, for sure. This is a huge chunk of my life’s work. But agreed, there should be opportunity to practice your skills whenever you have time or whenever you feel the need. There’s a whole domain called just-in-time training, where ... and there were studies done around this in pediatric intensive care units. When there was a child who needed to be intubated, and then it wasn’t an emergency. It was a planned intubation. The whole team would gather before, and they would go through a simulated intubation, and practice that immediately before going in and performing the intubation on the live patient, which is phenomenal. I mean, it gets the whole team centered, working together, and really sharing a common goal around getting that procedure done as safely as possible.

Harlan Krumholz: But aren’t we seeing that this isn’t a place where health systems are investing. I mean, it’s sort of invisible, right? So it’s just not an... Is it a priority for many places?

Stephanie Sudikoff: I think there’s a lot of variability. There are places that have things available 24/7. There are places that don’t. There are places obviously that have more resources than others. I think the challenge with 24/7 training is, yes, certainly, that provides somebody an opportunity to go in and practice a manual skill, but they don’t necessarily have the luxury of having somebody debrief them. And so, the debriefing that follows the simulations is really where all of the learning takes place. And so, I’m not saying in any way that that solo practice is not valuable, because it is, but the ideal is the opportunity to then debrief and really reflect and solidify that learning.

Harlan Krumholz: Yeah, that’s great.

Howard Forman: Any thoughts on the use of virtual or augmented reality now, with simulation centers? Because I realize that’s another layer that can be put on top of all of what we do.

Stephanie Sudikoff: Yeah. And that certainly is growing. And I was thinking that when Harlan was talking about the use of standardized patient actors, is that those trainings are fantastic but they are expensive, and they are really challenging to scale. And there are some companies that are starting to do some work around simulated avatars who can serve as that virtual patient actor. At the moment, most of them still require a human being to voice them. However, as A.I. has started to explode, there are some that have A.I.-infused feedback and the ability to listen to your vocal inflections and look at your facial expressions and have the virtual avatar respond appropriately, which is pretty amazing when you think about it, because then you can have somebody sitting in front of their laptop, and they can be practicing whenever they want. And I think that that’s probably going to grow in the coming years pretty quickly.

Harlan Krumholz: Well, thank you so much. Yeah, that’s really terrific having you on, and both hearing about the company and talking to you about this exciting area of simulation.

Stephanie Sudikoff: Well, thank you both for having me. I really appreciate it. It’s been fun.

Harlan Krumholz: Thank you.

Howard Forman: Thank you.

Harlan Krumholz: Well, that was a terrific interview. I’m so glad that we had a chance to have her on. There were so many different things that she could cover, but let’s get to what’s on your mind this week.

Howard Forman: Yeah. Look, you’ve already heard some. You gave me a good chance to talk about what’s on my mind, but I’m going to go in a totally different direction here, is a drug called Dupixent, which I see on TV commercials all the time. It’s a trade name for a drug called dupilumab, and I’m going to keep sticking to the word “Dupixent” because it’s easier. It’s a monoclonal antibody, which, there are a lot of monoclonal antibodies out right now. And this has been proven effective for atopic dermatitis or eczema. And in those patients, often these are severe cases—pain, physical skin lesions due to the inflammation and so on. It’s very effective for that. It’s also effective for a type of esophagitis and inflammation of the tube connecting our mouth to our stomach. And it’s effective for asthma. It’s also really expensive, like $30,000 to $40,000 or more per year.

And even with insurance, copays, et cetera, can still make this out of reach for a lot of people. And so this past week, a major trial called the BOREAS trial, and this is a good example of a press release substituting for science. So all we have is a press release, but they said that Dupixent is additionally highly effective in improving lung function and symptoms in patients with what we call chronic obstructive pulmonary disease, or COPD, in individuals who were or are smokers. So this is welcome news. And why is Dupixent so expensive? It’s the usual answers people gave. It takes a lot of money to discover a drug, to test it, get it approved, to continue and investigate, et cetera, et cetera. And monoclonal antibodies can be expensive to manufacture. And I always wonder, how expensive? And the answer is, it turns out, not very expensive, because as you and I have talked about recently, every six weeks, I take my 15-pound life partner called Ashley to the veterinarian to get—

Harlan Krumholz: Everyone in New Haven knows Ashley, by the way.

Howard Forman: That’s true. To get a very similar drug. It’s called Cytopoint. And she gets it also for her eczema or atopic dermatitis. And for her, it’s been miraculous, but guess what? It costs $65 every time we go. And even for a huge dog, it would be $140. But it is roughly 1/10 to 1/20 the price of Dupixent, even adjusting for size and dosing. So why is it so expensive? Why is Dupixent so expensive, and why is Cytopoint less? So there’s a lot of factors. We can blame it on the different standards for humans versus animals. We can blame it on market factors and so on. But it does start to give us a window on what a biosimilar for Dupixent’s going to look like as it begins to come off-patent in 2029. And it gives me at least a little bit of hope that maybe these things will become a lot more affordable. And I’d be curious to hear what you think because I worry about how expensive these drugs are, but this gives me a little hope.

Harlan Krumholz: I just wonder if there should be a black market with the veterinarians to—

Howard Forman: Well, so ironically, this particular one works on a animal interleukin receptor, whereas Dupixent works on a human one, but they’re substantially the same.

Harlan Krumholz: So they say, so they say.

Howard Forman: It’s true. True.

Harlan Krumholz: Well, Dupixent’s very interesting because, I don’t know, you may have noticed that it made big news this week that a Phase 3 trial—and these are the big trials that are used before for the FDA to make decisions about approvals and label extensions—show that Dupixent was actually pretty effective against chronic obstructive pulmonary disease. So this is already a blockbuster inflammation drug. It’s growing, and Sanofi and Regeneron have already got indications for asthma, atopic dermatitis, and esophagitis.

But now, it would be like the first biological drug to treat chronic obstructive pulmonary disease. And I’m just doing this to layer on top that this particular thing that came out this week was the second large trial to demonstrate its efficacy in treating chronic lung disease. It showed a 34% reduction in exacerbations that require further medical care, and it improved lung function after 12 weeks and also after a year. So in the first trial, cut flare-ups by 30%. So this drug seemingly is really important, can help a lot of people. Getting back to your initial point, which is access. So is everyone going to have access to it? I think you’re worried about also what is it going to do to the overall cost of care at the price point? It is, but I also worry with you about even at this price point, who’s getting access to it, given all of this?

Howard Forman: I agree 100%.

Harlan Krumholz: So an exciting drug, and there are a lot of other exciting things coming out of life sciences these days, but it has the potential both to increase disparities, and it may ultimately.... What’s going to happen to healthcare dollars? We’ve talked a lot about this with the anti-obesity drug. So yeah, I think really good point in this issue, about the veterinarians is interesting as well. So I don’t know where to go. People will complain about we’re going to stymie innovation if we bring the prices down, but it seems to me like we got to broker this somehow.

Howard Forman: Well, the one thing we know for sure is it will begin to face competition sometime soon, whether it’s 2029 or shortly after. That could be ... I mean, the biosimilar market is less than 10 years old. There is the possibility that these drugs get even lower than what we pay to treat Ashley once it’s generic.

Harlan Krumholz: Yeah. But you say that, but then look at our generic market? I mean, a lot of these generic drugs, insulin even, is—

Howard Forman: Insulin’s a bad example, though. I mean, it’s a horrible example, but I will tell you, I’m on—

Harlan Krumholz: A horrible example, you meaning that I brought it up? Or a horrible example of being able to drive prices?

Howard Forman: No, it’s exactly the second. I mean, it’s just the pricing has been horrible. But there are two drugs—

Harlan Krumholz: I just wanted to make sure listeners didn’t think you were chastising me....

Howard Forman: No, never. I would never do that. Yeah. There are two drugs that I take every day, and both of them were like $3 pills when they were brand drugs, and now they’re pennies per pill.

Harlan Krumholz: Yeah, and like statins, for example, has driven—

Howard Forman: That’s one of them.

Harlan Krumholz: Okay. Well, I mean, I didn’t mean to call you out, but I was just—

Howard Forman: No, no. And my flecainide’s another, it’s a cardiovascular drug, and it’s pennies per pill, and it’s miraculous. So I’m hopeful. There are going to be some biologic drugs that are never going to come down enough in price. But these will, the monoclonal antibodies.

Harlan Krumholz: And it seems like the government’s also stepping in, we’ve talked about that, and the Inflation Reduction Act also...

Howard Forman: Yes.

Harlan Krumholz: Do you see that happening with this drug eventually?

Howard Forman: Oh, yeah. I mean, Dupixent is going to clearly make the list. If COPD is added to the list, it’s going to make the list very soon, and it’s going to face price competition.

Harlan Krumholz: All right. Well, great. Thanks for bringing that up. You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.

Howard Forman: So how did we do? To give us your feedback, keep the conversation going, you can find us on any of multiple social media, or you can email us at health.veritas@yale.edu, and we are still hanging on by a thread to Twitter.

Harlan Krumholz: Despite all the things that are going on on Twitter. But yeah, I’m at H-M-K-Y-A-L-E, @hmkyale.

Howard Forman: And I’m @thehowie, T-H-E-H-O-W-I-E. Aside from Twitter, our podcast, I’m also fortunate to be the faculty director of the healthcare track and founder of the MBA For Executives program at the Yale School of Management. Feel free to reach out via email or see our website at som.yale.edu/emba.

Harlan Krumholz: It really is a terrific program. Health & Veritas is produced with the Yale School of Management and the Yale School of Public Health. Thanks to our researchers, Ines Gilles and Sophia Stumpf, and to our producer, Miranda Shafer. Incredible. Thank you. Thank you. Thank you.

Howard Forman: Thank you. Yes. Yes.

Harlan Krumholz: Talk to you soon, Howie.

Howard Forman: Thanks very much, Harlan. Talk to you soon.