Kate Heilpern: Jumping into the Deep End
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Howie and Harlan are joined by Kate Heilpern, president of Yale New Haven Hospital, to discuss the innovation and adaption needed to lead NewYork-Presbyterian Hospital through the worst of the COVID-19 pandemic, and how Yale New Haven Health structures itself to provide quality care across five hospitals. Harlan reflects on the many biotech startups emerging from Yale; Howie responds to the Trump administration’s assertion of a link between acetaminophen and autism.
Links:
Biotech at Yale and Beyond
“Investors Flock Back to Biotech After a Long, Cold Spell
“Boom, Bust and Recover: What Happens Next as Biotech VC Cycle Resets”.
“Pfizer to Buy Weight-Loss Drug Developer Metsera for Up to $7.3 Billion”
Health & Veritas Ep. 80: Josh Geballe: Turning Yale Innovation into Startups
Yale Ventures Annual Report 2025
“BioMarin to buy rare disease drugmaker Inozyme for $270M”
“Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018”
Kate Heilpern
“Yale New Haven Hospital announces new president”
“Heilpern sees society reflected in the busy ER”
“Meet the Heroes Fighting on the Front Lines Against Covid-19”
”’Adrenaline, Duty, and Fear’: Inside a New York Hospital Taking on the Coronavirus”
Health & Veritas Ep. 116: Christopher O’Connor: Hospital Leadership in Trying Times
“The 600 Pathways Yale New Haven Health Takes to Improved Care Delivery”
Tylenol and Autism
“Trump Issues Warning Based on Unproven Link Between Tylenol and Autism”
“Trump links autism and Tylenol: is there any truth to it?”
“The U.S. government has jumped the public health shark”
Learn more about the MBA for Executives program at Yale SOM.
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. Our guest today is Dr. Heilpern of Yale New Haven Hospital. But first, we like to check in on current or hot topics in health and healthcare.
Harlan, what do you have today?
Harlan Krumholz: There’s no hot topics in healthcare, are there, Howie?
Howard Forman: Oh my God. What a week.
Harlan Krumholz: Well, look, you already grabbed the hottest of all hot topics for your—
Howard Forman: I’ll try to do service to it, yeah.
Harlan Krumholz: We’ll hold it for that, and I’ll just talk about something a little more mundane, but, folks who are listening, stay until the end because Howie’s got a hard-hitting segment around Tylenol.
So, we are of course sponsored by the Yale School of Management, and I think, from time to time, we ought to reflect a little bit on what’s going on in investment, in markets. There was a period of what some people considered have been overinvestment in the biosciences for a while. And then that bubble kind of shifted around maybe 2021, 2022. And it has been a lot more difficult to get funding for some of these things, in part because the exits have been kind of blocked. What I mean by that is, when people are investing, they’re thinking, when are they going to get their money back? And part of that can either be that when there’s an acquisition, or if a company goes public, people can pull their money back out of it—at least some of it.
And, the acquisition slowed for a while, and also the IPOs. Going public went also slow. But this is showing some signs of stabilizing and maybe even reversing. And there’s still some enthusiasm. Just a couple of days ago, from when we’re recording this, Pfizer announced that it was acquiring Metsera, and I just say this because, actually, the guy who leads this, Clive Meanwell, is a friend of mine and has just done an extraordinary—
Howard Forman: Oh, I didn’t know that was Clive’s company. That’s fantastic. He’s the former CEO of The Medicines Company.
Harlan Krumholz: Yeah, The Medicines Company, and of course, he had sold inclisiran to Novartis for about $10 billion.
But what Clive will do is take an asset and then develop evidence around it and then put it in a position for acquisition. Of course, there’s lots of other acquisitions occurring around, but I was really happy to see this for him. They’re paying an initial $4.5 billion for it, and then there’s a bunch of milestones, contingent value rights they call them, that are additional payments based on hitting certain things.
And of course, Pfizer’s been wanting to reenter this market since their two candidates in obesity failed. And Metsera’s got kind of an exciting portfolio, with a GLP-I receptor agonist, that’s kind of like same thing as semaglutide, but they’re also going in with this once-monthly shot of amylin analog, which is another strategy into obesity, and the thought is that, combining these two might be a blockbuster. But the bigger picture was, it was nice to see, for Clive, but also just to see that we are seeing growing enthusiasm, not just for this, but along the lines.
And I wanted to segue this into a shout-out for Yale Ventures, because with our friend Josh Geballe and what’s going on at Yale Ventures, there’s a real push at Yale now to get some of these great ideas that are happening in the lab and in different places in lab. I mean, it could be wet lab, dry labs, meaning computers, whole range of different areas in Yale. But Yale Ventures helped launch 10 new spin-outs last year, and they signed 83 new licenses of work that had been developed at Yale. And of course, they brought together multiple gatherings of people to try to grow innovation in our community.
But I wanted to just tick off some of these because they sent them out. And I just want to say, there’s a company by Wendy Gilbert, professor of biophysics and biochemistry, Cloverleaf Bio, a computer engineering, new classes of RNA therapeutics. Stephen Strittmatter is chair of neuroscience at Yale, co-founded Allyx Therapeutics, which is advancing therapies for Alzheimer’s and Parkinson’s. Sidi Chen, you may have heard of Sidi as like this terrific faculty member in genetics who’ve co-founded this company, EvolveImmune, that’s pioneering high-throughput CRISPR screening and genome editing platforms. This means, going in there, snipping the DNA and putting in replacements.
Joseph Schlessinger, who’s been at Yale for a long time, was the founding chair of pharmacology, and he’s got another startup, he’s got a long line of startups. And Lieping Chen, who is a member of the National Academy of Sciences. There are lots of people, Howie, you may not have even heard of at Yale, but he’s a Yale immunologist, has a long line of startups. He’s now got a new one, Normunity, which just raised $75 million. He’s a guy who founded, I mean, who discovered the PD-L1 pathways for really starting this whole checkpoint inhibitor therapy that has so taken off.
And Demetrios Braddock, I know I’m just going down these, but it’s just like an abundance of good news. He’s a Yale hematopathologist who founded Inozyme, recently acquired by BioMarin for $270 million. And we just say the money, not because it’s all about money, but just to say value. That means that other investors or other people are finding value in this work.
And this is just a little bit of what’s going on at Yale, but I just was excited to get the email. I was excited to learn about these things that are happening, and it’s nice to know that Yale’s at the forefront. With all the stuff that’s going on, Yale is driving innovation, and these discoveries are leading to companies which are striving to make impact. Anyway, I was pretty excited to see it.
Howard Forman: I think it’s important for listeners to understand that all the greatest innovation in the world can go to naught if you aren’t able to bring it to the market, if you can’t bring it to the end user eventually. And the costs of going through the research part of it, and then the development part, including all the testing and then the FDA approval, is extraordinarily expensive. Most people would say that to bring a drug to market is a two-or-plus-billion-dollars proposition, when all is said and done. And so those early dollars, whether they’re $50 or $100 or $150 million, are absolutely necessary until you figure out whether something really works or not, and it’s a tremendous credit to all these individuals because they are taking risks themselves in many cases, and the institution is taking risks with them to try to see these things develop because they believe that it can have an enormous impact on the public’s health in the future.
Harlan Krumholz: I think it’s a really great point, Howie, that sometimes, people will look at this and think it’s like a money grab, these people are all starting companies and so forth, but I see it a little differently, and if you talk to them, you get a different feel for it. It’s people who have found something important, and they want to see it, as you say, go all the way to the patient. And in order to do that, to scale it, to prove it, to get regulatory approval, all of that stuff, if you really want to see your stuff making it all the way to the patient, it takes capital, it takes time. And in many cases, people have sacrificed a lot to get to this point.
Howard Forman: A hundred percent.
Harlan Krumholz: So anyway, I really do salute them, and I salute Yale Ventures for helping.
Howard Forman: Yes. They make a big difference.
Harlan Krumholz: I’m proud to be part of Yale to see all this stuff going out.
Howard Forman: I agree.
Harlan Krumholz: Hey, let’s get to our interview with Kate Heilpern. This is going to be amazing.
Howard Forman: Dr. Kate Heilpern is the president of Yale New Haven Hospital and the executive vice president of Yale New Haven Health. Previously, she was a group senior vice president and chief operating officer of New York-Presbyterian’s Weill Cornell Division, where she led the hospital’s operations through the COVID pandemic. Before that, she spent 22 years on the faculty at Emory University School of Medicine, where she practiced emergency medicine and served as chair of their emergency medicine department for 12 of those years.
She received her bachelor’s degree from the University of Virginia and her MD from Emory University School of Medicine and then went on to complete her residency in internal medicine and emergency medicine at Temple University Hospital, after which she served as a medical officer with the Indian Health Service at Fort Defiance on the Navajo Nation.
So, first of all, I want to welcome you to the podcast. It’s really a pleasure to have you here, and there’s like so many paths that I want to go down and ask you about. And I want to just start off, and then I’ll hand it off to Harlan, but with the COVID pandemic, because you moved over to Cornell into a role that you never even intended to take. It sounds like you were looking at jobs at that time and this enormous opportunity arose well before the pandemic, and then you find yourself in this leadership role at one of the hardest times to manage healthcare in New York. Can you speak just a few minutes about what that was like for you at that time in your career?
Kate Heilpern: So I had been at NYP for about 18 months before the first case of COVID arrived. And that was a really formative and important time because we were building on so many initiatives at that time and it really required a lot of relationship building and trust.
When COVID hit and the first case landed, late February/early March of 2020, I really felt as if we had a very trusted team, certainly on the hospital side, but also in dealing with the medical school faculty. It was an incredible example of everybody putting down any biases or any radio station WIFM, “what’s in it for me,” jumping into the deep end of the pool together, and really problem solving in such an incredibly creative way.
I was struck, almost on a daily basis, by the MacGyvers I found among me, whether they were clinicians or whether they were people in facilities or nursing or what have you. The same thing I know happened here and happened in many places across the country, but it was an absolutely remarkable opportunity to be at the epicenter of where this really originated in many respects.
Harlan Krumholz: I’d like to get to some of the things going on here, but since Howie opened the door to this pandemic topic, I wanted to get your view on this because I’ve got a kind of singular view of this that maybe isn’t as widely shared, which is that the pandemic in those first couple of months was different than the pandemic after that. And that if the pandemic that hit New York and, to some extent, New Haven and this part of the coast was the same as hit the rest of the country, we would have lost 10 or 20 or 50 million people, that it was a more pathogenic lower respiratory system virus. And as people sort of look back on it, they missed this, that much of the reaction that was built by the public health authorities was predicated on the experience that was going on in New York at the initial moment. And when everyone anchors on what’s happening today where maybe it’s equivalent to flu, it’s still causing loss of life. It still is a very serious illness for some people, but it’s a very different thing than it was at the beginning.
You’ve gotten to live through the entire spectrum. What’s your take on that? Because I really felt that what we experienced in that March, April, May period was not anything that everyone else experienced with regard to how it spread. I think the virus changed and maybe so did the hosts a little bit over time, but the virus changed in the beginning, I think. What do you think?
Kate Heilpern: I think you’re absolutely right about that. I would say that, if I would liken our experience perhaps in New Haven and New York City and a couple of other major metro areas, it was close to what Milan experienced...
Harlan Krumholz: That’s right. That’s right.
Kate Heilpern: ...in that same period of time. And then yes, there were iterations over time that really changed things.
Harlan Krumholz: You ran out of ICU beds, right? I mean, you were having trouble with number of ventilators. It was... I mean, tell me.
Kate Heilpern: Yep. So at the hospital that I had responsibility for, we had 114 ICU beds at baseline. And within a span of about four to six weeks, we increased to 250 ICU beds. Much like what was being done in other places, we were trying novel ways of thinking about having patients share ventilators in a split ventilator model. In some instances, that was successful, but that was a very, very difficult thing to accomplish.
But that’s what I mean by sort of the MacGyvering, when we were turning every single area that we could into safe spaces for advanced care for patients. And this included moving patients. We created an ICU in our endoscopy suite.
Harlan Krumholz: See, this is where I think people just forget this, though, which is when they say, “Why did we go to shutdown?” Because we had a city that was in absolute crisis, as if a tornado or hurricane had hit and everything was being scrambled, the resources were being shortened. And people want to look back and say, “Well, why were you overreacting?” Well, we didn’t overreact. I mean, that initial thing was presaging something that could have been even much worse than what we experienced. I mean, we were lucky that, and I hate to say “lucky” because we lost so many people, but it could have been worse if the virus didn’t evolve. Anyway, I just try to.... You were there, that’s why I’m bringing it up. You saw it.
Kate Heilpern: Yeah. It was really quite striking.
We also developed fantastic new partnerships that we never might have imagined with Hospital for Special Surgery. They shut down their orthopedic elective surgical volume. Obviously, they were available for incredible emergencies, but working with their leadership team, we actually were able to move COVID-positive patients to Hospital for Special Surgery and set up ICU capability at HSS. I mean, these are the kinds of things that this sort of crisis demanded, and people really stepped up.
Harlan Krumholz: There’s a lot to be proud of. People want us to say we should be ashamed of stuff, but there’s so much to be proud of about what happened.
I wonder if you could just explain to listeners who might not be familiar with, what’s it mean to be president of Yale New Haven Hospital and senior VP of the system? People sometimes get confused about these titles, and can you give some sense of how’s it organized?
Kate Heilpern: I think that’s a great question. So, we have organized ourselves by delivering networks for the complexity of the Yale New Haven Health System, so we have five hospitals. Basically, that’s spread out geographically across 150 miles, predominantly the Connecticut shoreline, but reaching into Rhode Island. And, it is a wonderful healthcare delivery system with a CEO at the top, Chris O’Connor, very traditional and wonderful model. And Chris has a number of direct reports, one of whom is Pam Sutton-Wallace, who serves as the chief operating officer, essentially, and president for the entirety of the system.
I report to Pam Sutton-Wallace, as do the other delivery network presidents, Greenwich, Bridgeport, Lawrence + Memorial, and Yale New Haven Hospital. That’s in my role as president.
I have an additional role as senior vice president that is a system role. And in that construct, the majority of the service lines report to me, so heart and vascular, transplant, digestive, urology, and the like. That’s a typical way that many healthcare systems have organized themselves across a series of specialties that are like-type, that go together in the delivery of care, often combining medical care with surgical and procedural care, to do the best thing that we can do for the patients.
Harlan Krumholz: So just to say, you are responsible for everything that goes on in Yale New Haven Hospital, plus cross-cutting lines like heart and vascular across the entire system so that you can harmonize the services and the communication, so that the patient experiences it as a singular system, as opposed to having to hop from hospital to hospital. Is that right?
Kate Heilpern: That’s exactly right. And so what we aim to do is provide that same level of high quality care, no matter where the patient may intersect.
Now, I think, importantly, what we should maybe draw a little bit of compare and contrast on is that not every hospital in our system has the same level of capability in terms of high-level, complex, what we call quaternary care in medicine. And so, in some instances, it’s almost a hub and spoke. So the most complex care is done at Yale New Haven Hospital, which makes sense, sitting as the academic medical center, with Yale Medicine directly across the street. But we have placed the opportunities for all these services at every delivery network or every hospital across our system.
Howard Forman: I’m biased by practicing radiology inside the emergency room, and so I see the emergency room as sort of both a mirror of society, but also the entryway to the hospital, and it’s also a reflection of our operations in many ways.
And you are an emergency medicine physician, and we are not unique at Yale on having an overcrowded emergency room on many days, and we are not unique in seeing many people who have the greatest needs in the community, who are not being met by their own primary care doctors, for instance, or may not even have the usual source of care. What is your role in working with Arjun Venkatesh, who’s the chair of emergency medicine, and others, to try to resolve bigger issues around healthcare and the gaps in care that exist in a large community like New Haven?
Kate Heilpern: Such a great question, Howie, and straight to my core and how I have spent more than 30 years in healthcare.
Emergency medicine has, in many places and in many respects, become the safety net for many healthcare systems and, frankly, even across the state, and boarding, or the practice of holding on to patients in the emergency department who require an inpatient bed, is unfortunately a scourge that we struggle with, again, nationally. It’s rooted in many different causes, and we know that boarding is associated with quality and patient safety issues, so we want to do everything we can to minimize that for our patients.
But it’s complicated. It’s complicated. It’s complicated because, as patients are sicker, and if we’re working in an area where we’ve got a more socially vulnerable patient population, sometimes, it’s more difficult to connect that patient to urgent care in the ambulatory setting.
So the work that we are doing with Arjun is really multifactorial. One, we’ve developed a very robust ambulatory strategy and leadership team, so that we’re growing primary care across the Yale New Haven Health System and, frankly, throughout New Haven and the surrounding communities, so that patients may actually avoid an ED visit, in the first place if they feel comfortable that they can get to a primary care or specialist appointment within a matter of a couple of days. So that’s one really important piece.
If they do come into the ED but they’re deemed safe for discharge, we want to be sure that they can get seen quickly. So, one is, the potential to not come into the ED in the first place. The second is, if seen, can we feel comfortable that they can be seen as an outpatient soon thereafter? And we are working avidly, avidly, across the entire hospital to decrease length of stay and focus those efforts. That is a complex body of work that involves the perioperative team and smoothing OR cases across days of the week. It’s ensuring that we have case management to help patients with needs that they may have once they’re discharged from the hospital. It’s ensuring that our consultation services, our imaging services, our lab services are operating at the top of their ability so that everything we do is as efficient as possible.
In candor, we haven’t solved this problem yet, but we are working very, very hard and making improvements on it.
Harlan Krumholz: Who has solved this? I mean, when somebody from the outside might just simply say, “Why don’t you double the size of the ED and double the number of providers?” I think it’s like traffic—the more you do that, the more the lanes fill. Has anyone solved this?
Kate Heilpern: I think the organizations that have solved this are generally organizations or hospitals that are working in areas where social determinants of health needs may not be as deep as they are in a lot of the major metropolitan areas, and many academic medical centers are sitting in metropolitan areas. And so it becomes kind of an embarrassment of riches, so to say, that too many things come together and create this bit of a problem.
Howard Forman: I’ll just say that, even though we’re radiologists, we are very fortunate to have a very deep electronic health record that gives you access to a lot of information. And I am just floored by the number of patients that come to the ER primarily for social services of one type or another, and we do not turn them away. I mean, we have people who show up, who have literally said in their history, “I think I just need a place to lie down.” And we cannot turn those people away. We try to respond to their other issues as well. And some of these patients have, in their history, “six liters of vodka today” or something like that. And it just reminds you that these are well beyond the control of the institution, but nonetheless, we can play a leading role in working within our communities to try to solve them.
Kate Heilpern: And the leadership across Yale New Haven Health System is very focused on this, and you’ll hear us talk a lot about access and ways in which we can help patients get into our system more quickly. That’s the work that’s also happening, I think, at a number of other systems across the country.
Harlan Krumholz: Just as we come to a close here, first, just immense gratitude for taking the time to be with us. We know how busy you are. As you look ahead, I mean, I know that a lot of the day-to-day is about solving problems right in front of you, but I also know that, based on what I know of you, you’re also looking out beyond and where we should be going. What’s your best hope about where we should be five or 10 years from now with regard to the health system and the hospital? Obviously, so many uncertainties, policies, everything, but if you could help direct us in a certain way, what would you like to see happen?
Kate Heilpern: Well, one of the pieces I want to talk about for just a moment is around our quality journey. And I think we’ve got exceptional leadership in quality and patient safety, for the hospital, and also from the medical school and community physician perspective. And our journey in quality is one of just continued rise, and one of the ways that that’s happening is through the care signature work. So we are basically, that’s a phrase that we’re applying to our standard of care, so there is a Yale New Haven Health System way that we are managing both simple and complex problems. It is evidence-based, it takes into account efficiencies, and it also takes into account the state-of-the-art care that many of the researchers and translational scientists at Yale are helping us to move towards. So our quality journey has been spectacular, and I look forward to continuing to be part of that.
Same is true of our patient experience journey. Every day, as president, I think about, as I do my walk-arounds or as I talk to frontline staff, “What does this feel like for this individual who’s lying on a gurney, sitting in a hospital bed, or in the ICU? What does this mean for them? What does this mean for their family? How can we make this as easy as we possibly can, understanding how difficult it is to be acutely ill or injured?” And so we’re doing all we can to enhance communication and deliver the compassionate care that I think every person under our care really, really deserves. So, those are things we’re moving forward on.
And then of course, enhancing the array of clinical opportunities. And I have to just say, I’ve been a lot of places in my career, but the translational science that’s happening at this institution collectively, with the medical school, is absolutely staggering and I think gives us an incredible position, nationally and globally, to deliver really cutting-edge care.
Howard Forman: Well, we are very lucky to have you and your colleagues, many of whom we’ve interviewed on the podcast in the past, leading this institution, because it is not easy and there are more challenges ahead. We can talk a lot about what the future holds for health systems, but I am confident that we are in a good position with you helping lead.
Harlan Krumholz: That was just a terrific interview and—
Howard Forman: She’s amazing. We could do this on and on again. I really do want to get her back.
Harlan Krumholz: Yep. That was terrific. But now, you know I gave a little teaser at the beginning. Howie, take it away.
Howard Forman: I can’t ignore the president’s news conference from Monday, which was yet another moment when politics and populism seemed to have trumped science in the public’s interest, because while there is uncertainty as to whether acetaminophen, the active ingredient in Tylenol, is a cause of some autism spectrum cases and/or attention deficit hyperactivity disorder, there is no uncertainty over the fact that the general consensus right now is that we do not have a full answer about this, and no new news has been made in the last week to justify that conference.
The uncertainty around this arises from the fact that we can’t and don’t do randomized trials on pregnant women, and we therefore end up relying on various observational studies to identify a correlation but not necessarily a causation. And with acetaminophen, there are enough studies that raise some concern to be worthy of our attention. Just to be clear, there’s so much unknown that even if one says they have a real concern, it should be noted that the level of impact, even if it’s real, is likely very, very low. But low is still something to consider.
The issues that end up being raised are confounding factors. Are women taking acetaminophen for mostly random reasons, and therefore, if you see a correlation, it likely means it’s causative? Or, are they taking acetaminophen because they have migraines or high fevers or something else that correlates with taking acetaminophen rather than the acetaminophen itself, in which case you’re actually dealing with correlation, not causation?
Studies have tried to tease this out, but they can only do so much, and the scientific consensus is that we do not know the answer. And one of the best recent studies, involving siblings in Sweden, comes to the opposite conclusion of the president and his healthcare staff.
We must get better answers to this question, but my serious quarrel with the news conference is not that the information is wrong; it is that the guidance to women should be coming from trusted professionals and not from those who might be leveraging the anxiety of the public over growing counts of autism cases. And I specifically use the word “counts” because it is unclear how much of the growth in cases is actually due to finding cases that were never previously identified versus some genetic or environmental factors that might be changing the numbers that we’re actually seeing. We should absolutely be searching for answers and then providing them with deliberateness, thoughtfulness, and compassion—not for political points.
We also want to highlight that we should all consider, what we put in our bodies has some risk of untoward effects. Acetaminophen may be an over-the-counter medication, but it is not without its own risks, and recent changes to labeling even remind us that lower total consumption is safer and better, so it should always be the case that we advise patients, all patients, to take the lowest amount of a medication that will satisfactorily resolve symptoms, for them, under the guidance of their physician or nurse practitioner, etc.
For women, for pregnant women, there are no other safe pain or antipyretic or anti-fever remedies. If there were, we would have a different conversation today.
Also a reminder, there have been numerous fake-outs over the last century. We once thought ulcers were caused by stress, that hormone replacement therapy reduced the risk of heart disease, that AIDS was caused by environmental factors, that vitamin E was cardio-protective, that beta-carotene protects against lung cancer, or that tonsillectomy was protective against future infections. All of these, to one degree or another, have been disproven, occasionally even proving the opposite. It is why we do not jump the gun on science—or at least we try not to.
It is just as important, and I want to emphasize this, for those mothers of neurodivergent children out there, to understand that while many of them may start to blame themselves for causing differences in their children, the weight of the evidence is strongly against this hypothesis. For women who are currently pregnant, talk to your OB-GYN or primary care provider to make the best decisions for you and your fetus. Important to highlight that suffering in pain or with fever may in fact be very harmful, so please seek advice.
Harlan Krumholz: So, Howie, you show great courage going into this topic because it’s a hot potato right now, right? I think the consensus scientific opinion is that current evidence doesn’t support this causal relationship. And yet, there were large population-based studies and meta-analysis that reported these small associations between prenatal acetaminophen exposure and increased risk.
And then there was people concerned that this was what we call confounding, that in fact, there are other factors, as you said, that track with this. And then the Scandinavian study that used sibling control designs, meaning that the control was a sibling who wasn’t exposed to acetaminophen and to see whether or not that showed it. And that study, as you said, didn’t find the relationship.
On the other hand, acetaminophen does cross the placenta. So by passive diffusion, it allows the mother’s levels of the drug to reach the fetal circulation in clinically relevant concentrations. And that some studies have demonstrated that the levels will equilibrate pretty rapidly between the mother’s system and the fetal system. And we say this because there’s some things that don’t cross that, so it just stays with the mom. But in this case, there is transfer.
I don’t think there’s anything wrong with saying that if people.... This is a personal choice, that this isn’t a done deal. There’s no definitive evidence. There are some suggestions and there’s some studies that have discredited those suggestions. And if people want to err on caution, they would avoid it to the extent that they could, but not to the extent that if you had very high fevers. High fevers can also affect the fetus. So, we’re sort of—
Howard Forman: Pain, mother’s pain, severe pain can also have adverse impacts on a fetus. I mean, there’s so many impacts there. I think it’s important for people to understand, it is a medication, you should take it carefully, like any other medication. But given that there’s no alternative to it, I think that it is... And given that we have actually the 70-year history with it, I think there are enough reasons to say that if it is a factor in some cases, it is a small factor.
Harlan Krumholz: Yeah. I guess I would say... This is where we may depart. I think that, for my kids and my wife, I would say, avoid Tylenol if you can. I mean, what we want to get away from is people just popping Tylenol thinking this thing is benign. It doesn’t cause bleeding like aspirin. It’s a painkiller. We know everything about it. We don’t know everything about it, and I think that there’s more to learn. And I’m just saying, all things being equal, why take it? Like you said, if you’ve got an indication, if you’ve got a reason to take it and there are no alternatives, that’s a whole different story.
But I do think this thing gets politicized to the extent that he did say a lot of bizarre things in this press conference, and it just becomes like, they’re coming at you so fast, these things that aren’t based on strong science, let alone science at all. And so, when it comes to Tylenol, I don’t think there’s anything wrong with saying some people will choose not to use it, and some people will wait until more definitive evidence comes out before they act on this. But it didn’t come out like that. And he didn’t sound like that. He was just going on and on, like avoid Tylenol as if it were poison, and I think that ends up putting this in a space where then now everyone starts reacting because it’s not what we’re used to, it’s not evidence-based.
But by the way, when you said highly credible people, he was surrounded by Jay Bhattacharya, Marty Makari, Mehmet Oz, and RFK Jr., but he had his three doctors there who were leading the government on this side, which again, as Art Kaplan has written, Howie, it’s led a lot of people to say we’re losing faith in the government.
So in the end, I think, not a great day for instilling confidence, because all it did was continue to split the population and lead to a lot of confusion.
Howard Forman: I agree.
Harlan Krumholz: But I’m just still going to say, my daughters get pregnant, I’m going to tell them, “Why take it if you don’t need to?”
Howard Forman: I think nobody should take Tylenol if they don’t need to, period. I think that if people are afraid to take Tylenol and they raise their thresholds for taking it so high, they may be actually causing harm as well. I think we need to give people enough latitude to know that everything they put in their body has some relative risk and they should think about it, but they should make a decision with their physician, with their family members, not letting the president tell them what to do.
Harlan Krumholz: I love when we come together in the end. Well, I mean, let me just say, when you say “not letting the president tell you what to do,” I fully endorse that. But we are trying just to stay on the facts here too and just to say it didn’t support…. There was no new evidence, and there’s really a lot of uncertainty.
Howard Forman: That’s right.
Harlan Krumholz: That’s the problem.
You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.
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Harlan Krumholz: Health & Veritas is fortunate to be sponsored by the Yale School of Management, the Yale School of Public Health. We’re also very fortunate to have superstar undergraduates working with us, Tobias Liu and Gloria Beck, an amazing producer who somehow makes us sound okay every week, Miranda Shafer, despite the fact we give her very raw footage to deal with. And I’m working with the best co-host in the business, Howie Forman.
Howard Forman: I appreciate it, Harlan. Thanks very much. Talk to you soon.
Harlan Krumholz: Talk to you soon, Howie.