Aaron Kesselheim: Law, Policy, and Health

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. Aaron Kesselheim. But first, we like to check in on current hot topics on health and healthcare. So what’s the topic today, Harlan?‌

Harlan Krumholz: I don’t know. I’m obsessed about microplastics, Howie.‌

Howard Forman: Yeah. Well, tell me more.‌

Harlan Krumholz: There’s always one more thing to worry about, but I don’t know why, I think I finally got this. So imagine you’re sipping your coffee or brushing your teeth, and then guess what? In just doing those simple acts, you’re ingesting tiny pieces of plastic. These plastics, which are smaller than five millimeters, are everywhere. Oceans, air, food, and, of course, in our body. But only recently people really been talking about this. ‌

What does it mean for our health? And this is really the billion-dollar question scientists are now racing to answer, and these articles are appearing more and more. So just to get down to it, microplastics are fragments of plastics that form when larger items like packaging or water bottles break down, you can’t even perceive them. I mean, you look at the water bottle, it’s a regular water bottle, but it’s degrading all the time.‌

They come from sources like car tires or synthetic clothes, even in the microbeads in some personal care products. Every week, it said that every person consumes about five grams of plastic, the equivalent of a credit card. So initially research was focused on microplastics in the environment. It wasn’t actually about health. So people were talking about, “Gosh, they’re in the ocean, and what is it doing to fish?” But then they started finding them in blood, lungs, even the placenta in humans. In one study, they were found lodged in arteries, and the people who had higher levels seemed to have higher risks.‌

Howard Forman: So that’s pretty scary. How do we measure something that’s so tiny? How do we even find it?‌

Harlan Krumholz: Well, that’s a great question. So there are basically three main methods. First, they can analyze environmental samples like food, water, or air, or they can look at human samples like blood or feces or even organs to measure microplastics directly. But third, now they’re using computer models to estimate exposures and daily activities because they know that they can predict very well what your levels would be as a result. And interestingly, who has the highest risk? Babies. Babies seem to have the highest risk because studies are showing that formula prepared in plastic bottles can expose infants to millions of these particles daily.‌

Howard Forman: What can we actually do about that? I mean, particularly with baby bottles, short of shifting to paper bags.‌

Harlan Krumholz: So the question, should we be changing everything dramatically? And that gets to, what do we really know about the health risks? And this is where it gets tricky. While there’s evidence linking microplastics to inflammation, cardiovascular disease, and even cognitive decline in animals, human studies are really just beginning. So imagine this, how we’ve had a major change in our environment and our exposure, and we know really little about this. In November last month, Nature Medicine had a study that highlighted that microplastics can carry toxic chemicals like endocrine disruptors that are linked to diabetes, infertility, and developmental issues. Could this be the reason that we have so much obesity? Could this be the reason that we’ve gotten a lot of the health problems that we’ve seen grow dramatically in the last couple decades? And what people are saying... You’re asking what you can do, people are saying avoid heating plastic, these plastic containers. Actually at home, we’re saying, let’s get rid of all these plastic containers that are in the refrigerator. Don’t heat up leftovers in them. When you get food from a takeout—‌

Howard Forman: Takeout, yeah.‌

Harlan Krumholz: Don’t be putting that in microwaves to reheat it when it’s in plastic. Put it on plates. And you could say to me, how sure are you that that’s going to help? I don’t know. But that’s a small thing to do while we’re trying to figure this out, and it’s making me rethink this idea of water bottles and a whole range of things, but I just don’t think we can get away from it right now. The question is, let’s just try to understand it, at least.‌

Howard Forman: Yeah, it’s a fascinating topic, and it has come up with talking to people, and I sometimes think they’re kidding. And now I listen to you, and I realize it’s a serious topic.‌

Harlan Krumholz: Yeah, I don’t know where... because we’re surrounded by it, but at least we ought to understand and see what we can do. If it is causing problems, what can we do to mitigate it?‌

Howard Forman: That’s great. I really appreciate you explaining that.‌

Harlan Krumholz: Hey, let’s get onto our guest, though. We got Aaron Kesselheim to come in today. He’s terrific.‌

Howard Forman: Dr. Aaron Kesselheim is a primary care physician, a patent attorney, and a professor of medicine at Harvard Medical School. He’s the founder and director of the program on Regulation, Therapeutics, and Law—or portal—an interdisciplinary research center that studies how laws and regulations influence therapeutic innovation and is based out of the Brigham and Women’s Hospital and Harvard Medical School. Dr. Kesselheim’s research focuses on how intellectual property laws and regulatory policies affect pharmaceutical development. He has testified before Congress on pharmaceutical policy, drug and medical device regulation, and clinical trial reform. He’s the editor in chief of the Journal of Law, Medicine, and Ethics. And in 2020, he was elected to the National Academy of Medicine. He graduated summa cum laude from Harvard University in 1996 and has his MD and JD degree from the University of Pennsylvania, before going on to Harvard where he earned his MPH degree and completed his internal medicine residency at the Brigham and Women’s Hospital in Boston.‌

And I want to start off with one quick anecdote. And I’ve said this in front of you before, but I’ll just say it again. You are the only person who I’ve received a rejection letter from that was like the kindest, nicest note I’ve ever seen. When you applied to the Clinical Scholars program at Yale, most people send a note shortly after saying how much they loved coming here. Several months later, you sent a note saying that you wouldn’t be coming here, but you’ve loved your visit so much and you hoped you would stay in touch with us. And here we are staying in touch with you about 20-plus years later and continuously through that time. You teach at Yale now. And I still remember that, and somewhere in this office, I do have that letter still here, but you have been in our lives for over a couple of decades and in the public’s life for that period and making a real impact on public policy.‌

And two themes of the last nine months that have come back to us several times on the podcast are Chevron deference and GLP-1 or obesity drugs. And just to remind our listeners: Chevron deference refers to a Supreme Court ruling from about 33 years ago that basically said that the agencies, the executive branch have expertise, and they can interpret rules and regulations using their expertise. And just last year in a separate ruling, they overturned Chevron deference, basically saying that we shouldn’t count on the executive branch to always be able to interpret regulations and that we may need the courts to separately interpret them.‌

And so I’m going to start off with a question pointedly about that. Harlan last week let us know that CMS and President Biden are suggesting that or are going to reclassify obesity drugs in such a manner so that Medicare and Medicaid would cover them. But at the same time, what we learned from Reshma Ramachandran and from Tim Westmoreland in the last year’s podcast is that the overturning of Chevron deference can make a meaningful difference in our access to drugs and other regulations might change. And I’m wondering if you have some thoughts on the relationship between Chevron deference and the approval of obesity drugs for Medicare and Medicaid.‌

Aaron Kesselheim: Sure. So first off, thanks for inviting me to talk with you, and it’s great to be here, and I have really enjoyed being able to collaborate and stay in touch. But as to your specific question, I think it’s important to recognize that when the Biden administration took the step of suggesting that Medicare would cover GLP-1 drugs, first of all, it was only a proposal, and there is not enough time between now and the next administration to finalize the proposal. So if it is going to go forward, it is something that the subsequent administration is going to have to take the baton on. But if we do kind of move ahead down the road to a time when it is enacted, and if it does get followed through on, essentially what CMS is doing is they are reinterpreting their previous interpretation of the statute that says pretty explicitly that CMS is not going to cover drugs for obesity.‌

And they’re classifying obesity as a chronic disease so that now they do have the latitude to cover effective drugs for that condition, of which the GLP-1 drugs are clearly effective drugs for management of obesity. And so because that process involves CMS reinterpreting its prior interpretations, it can be challenged in court. And under the new standard, the post-Chevron standard, we are supposed to believe that courts don’t have to show the same amount of deference that they would to agency interpretations.‌

And so there would be more flexibility, assuming that it is challenged in court and assuming that it finds a judge willing to take the step for judges to exercise their own interpretation of the issue and come to a different conclusion. That’s what this post-Chevron situation puts us in is that there’s more flexibility for judges to impose their own decision-making in place of those of expert agencies. And so yeah, I do think that we’re thinking multiple steps down the road here. This kind of guidance is more subject to having courts overturn it. By contrast, if Congress passed a statute that said Medicare will cover drugs under these circumstances, then there would be more clear footing going forward.‌

Howard Forman: Right.‌

Harlan Krumholz: I think Aaron is sort of a rock star, this guy, the thing about him is that he works... he’s a physician, of course, an attorney, a researcher. There’s never been a time, I think, in our history where it’s more important to have people to sort of understand this intersection. There are people who are steeped in policy and in clinical medicine, but the law itself has its complexities. It sort of requires people to have that sort of joint expertise. And I think there was a time when we may have thought like, well, how many degrees do you actually need in your life? And he’s got a full portfolio of them. But the truth is you actually do need these sort of perspectives and to bring together the sort of public health, what it’s like to sit across the bedside from a patient to understand the complexities of clinical medicine and what the law can and can’t is becoming increasingly important.‌

But there’s another facet here I wanted to bring up, which is one of courage. Being able to actually stand up for what you believe in being put in those positions. Aaron, you were in a position with an FDA advisory committee with Aduhelm, where you were participating avidly in making recommendations to the agency about what they should do with regard to approval decisions. And you were in a leadership position, and you did something that was fairly unusual. I wonder if you could just talk to the audience a little bit about what happened and why that happened and what led you to make the decisions you did. Because I think it’s a really interesting story, but I had such great respect for the fact that you were willing to stand up for what you believed.‌

Aaron Kesselheim: Sure. So I was on the FDA Peripheral and Central Nervous System Advisory Committee. So the FDA has a different advisory committees made up of independent experts in a lot of different fields. And I was appointed to that committee in 2015. And then in 2020, the committee was convened to review a new class of Alzheimer’s disease medications, monoclonal antibodies that do a very good job pulling amyloid deposits out of the brain. But as a committee, we were presented with the clinical trial data that was not as clear. And there were two different studies that, one identified a potential less worsening of patient’s Alzheimer’s disease. The other showed no difference. And across both studies there was a 30 or 40% increased risk of brain bleeding and swelling that could be really severe for patients. And so at the advisory committee, we talked about these data, as you do at advisory committees, and we voted nearly unanimously with one abstention that the data did not clearly show that the drug worked, and yet we were very concerned about the drug safety.‌

And so then six months later, the FDA approved the drug anyway. And again, they can do that. The advisory committee recommendations aren’t something that the FDA has to follow. And indeed FDA tends to follow those recommendations only about 80% of the time, not 100% of the time. But I thought what was important as part of that approval was that they went back and approved the drug, not... because they said, “Well, our interpretation of the clinical data is different.” They said, “We’re going to approve the drug because it removes amyloid from the brain.”‌

And actually at the advisory committee, they had said, “We’re not going to approve this drug on that basis. What we want to do is you want to approve a drug because it actually works for patients.” And so they actually went back on their previous statements and in the context of another advisory committee for a different drug for muscular dystrophy a few years back where they had also made a decision different from the advisory committee, I kind of was concerned not only about the bad decision that I thought was a wrong decision, but also that I thought that the process was problematic and that the advisory committee was not being used for the purpose of providing legitimate advice and having them weigh that advice that it was more just for show.‌

And so I resigned from the advisory committee, and I made those points in a letter and said, “Look, I really love serving on the advisory committee. I really think it’s an important part of the FDA process, but I really don’t think that the advisory committee is being used in the right way when it doesn’t appear that the recommendations being made that all of these experts taken all this time and effort to make these recommendations are really being considered in good faith.” And so I resigned from the advisory committee to try to bring attention to the fact that this advisory committee process needs reform so that it can fulfill the function it has of improving the integrity and the trustworthiness of the FDA. And so that was what I did. And then I think that the good thing was that as part of that process, I then became one of the voices that people went to.‌

Now that they had approved this drug, different hospitals and health systems had to determine whether to cover it, and physicians had to determine whether to prescribe it. And so I certainly suddenly was thrust into this position of providing an opinion on the safety and efficacy of this drug as they were considering what to do with it. And so over the course of the next couple years, it became increasingly realized that few systems were going to cover this drug, and the drug ended up ultimately getting functionally pulled from the market by the manufacturer. So I do think I succeeded in a way of bringing attention to the bad process that led to the approval of this one particular drug.‌

Although I feel bad that since then, there have been a number of other controversial drugs that have come through that advisory committee. I would have loved to have been part of those conversations, but I do think it was important to bring attention to that part of the process. And so yeah, it was kind of fun. I’d never been on the cusp of the news cycle for... you can understand why celebrities and others who are on the news cycle constantly turned to alcohol. It was stressful for somebody who’s otherwise not necessarily used to seeing his face on the front page of CNN.com. But I think it was an important step that I took.‌

Harlan Krumholz: Well, just one quick follow-up was just... the question is whether or not this advisory committee process has improved in any extent? There’ve been lots of meetings about them. People are talking about them now. The one thing I like about them is that they’re all in the public view. The documents are in the view, the discussions are in the view. So regardless of what happens in the meeting, it at least is a platform for a lot of data to be put out for people to see, and whether or not they listen to or care about what the experts say, people can look at it themselves. But I’m afraid actually little has changed since you left.‌

Aaron Kesselheim: So I agree with you. I think the advisory committee process is a really important part of the process and that kind of transparency aspect of it in that it gives insight into the FDA decision-making, provides an opportunity for patients to directly interact with the FDA. I think that all of those things can be very useful in supporting the integrity and trustworthiness of the FDA if it’s used correctly. I think that unfortunately over the last decade, for example, the number of advisory committees being organized by the FDA has been cut in half. It used to be that about twice as many drugs would have advisory committees before they’re approved then they are now. And I think that there’s concerns about the ways that the questions are being asked at the advisory committees and who’s serving on the advisory committees.‌

Harlan Krumholz: I didn’t even realize that. I thought all the drugs went through advisory committees. Only some of them do?‌

Aaron Kesselheim: No, these days, actually fewer than 10% of new drugs get advisory committees. As recently as 10 or 15 years ago, it was 20, 30% of new drugs were getting advisory committee review. So yeah, I do think that an FDA administration that was really interested in trying to promote transparency and promote integrity, that a vibrant advisory committee process of truly independent, non-conflicted experts in clinical trials and biostatistics and epidemiology sitting around and having this public discussion about investigational drugs, I think would be invaluable.‌

And I do think it is something that as being... And unfortunately, as you said, Harlan, I don’t think that the process has improved much in the last couple of years. Actually, the one thing that I have heard in terms of reforming advisory committees is that they’re thinking about whether or not they should take a vote away from advisory committees and that advisory committees should just talk all day and then shouldn’t have a vote at the end, which I think would be a terrible idea because then that would allow for selective interpretation of a day’s worth of discussion as opposed to a crystallized recommendation at the end of the day.‌

And so I think that would actually be a step in the wrong direction. So hopefully we can, but I do think that the... The good news is that I think there are people who recognize that the advisory committee process does need some reform. And so we’ll see whether or not that’s a priority in the next administration.‌

Howard Forman: So speaking of the current administration and the next administration, you gave testimony in front of the House Ways and Means Subcommittee on health, I think, this Congress, the current Congress, a year ago. And two main themes came out of that—to me, I’m sure there were a lot more in there. One was that we should be increasing our funding to the NIH since it is a means of promoting innovation, biomedical science. And the other is that we should be using Medicare and I think presumably Medicaid payment policy in a more constructive manner about how we pay for therapeutics so that we’re paying for true innovation and not necessarily just paying for marginal improvements. Can you speak a little more to how that was received? You’re invited, presumably by the minority members, to speak there. It’s a Republican-controlled House at that moment. We are in this very, very razor-thin partisan position right now going into this next year. How was that received, that testimony?<start>‌

Aaron Kesselheim: I think it was received positively. I mean, the context of that testimony is that after the Inflation Reduction Act was passed, which gave CMS the power to negotiate a small number of prices for prescription drugs for a small number of drugs at the very end of their market exclusivity only for the top-selling drugs. But it is a transformational piece of legislation in that Congress had never given CMS this authority before in its history. And so this was a very big step. What we saw is after that bill was passed in 2022, there were some bills proposed by, sometimes mostly by Republicans but also sometimes by bipartisan people, all backed by the pharmaceutical industry to try to scale back the negotiations in various ways by expanding the exclusions for drugs that would not be able to qualify for negotiation or otherwise limiting CMS ability to negotiate in various ways.‌

And so that testimony was conducted in that context, and I think it was successful in the short term because none of those bills made it through Congress this year. But we’ll have to see what happens next year with the new administration where now we’ll have a Republican control of both houses and president that... although he has said before that they want to make sure that they negotiate, that they get good deals on drugs. On the other hand, they also seem to dislike everything that went on over the last four years and seem to be very close with corporate partners in the pharmaceutical industry. So we’ll see whether or not there are more efforts made to try to scale back negotiations or otherwise limit it.‌

Again, I think that if the new administration is really about trying to improve efficiency and trying to reduce waste and trying to encourage manufacturers to innovate most effectively, I think we should be expanding negotiation, because it seems like the worst signal you could send would be to pay whatever the drug companies say that they should pay for their drugs and not to use the ability that we have, the fact that Medicare covers a third of prescription drug costs in the United States. To actually use that power to negotiate fair, reasonable prices that could both ensure that people get reasonable access and ensure that pharmaceutical companies make a fair return on their investment.‌

But I guess we’ll see. And then of course, as to the NIH, that unfortunately is also part of the discussion... is going to be part of the discussion going forward. We’ve done a lot of work to show that public funding has helped generate some of the most important drugs that we have. And so if there are efforts made to try to cut NIH funding, I think that would be truly devastating for the pharmaceutical innovation schematic because drug companies in general don’t do the key basic and translational work that helps identify the pathways and receptors that are going to be the basis for the cures of tomorrow.‌

Now these days, they’re doing even less of the early proof-of-concept studies as well but waiting until the drugs have proven themselves and the risk has been reduced as much as possible before getting in. For example, a lot of the gene therapies that we have these days, those were developed and tested for many years in academic research settings before the drug companies got involved at a later step. So if we do cut the NIH budget or, as RFK has suggested, maybe turn half the NIH budget wellness and other alternative medicine kind of stuff like the truly out-there ideas, I really think that would be devastating for pharmaceutical innovation.‌

Harlan Krumholz: I know we’re getting closer to the end here, but I wanted to ask you about this HarvardX course that you do on prescription drug regulation. So is it true that you’ve reached over a hundred thousand people with this course?‌

Aaron Kesselheim: Yeah, we developed an online course that describes the core concepts of drug regulation and drug pricing working through from discovery through FDA approval through coverage of drugs after approval. It’s been about six or seven years now that we’ve offered it, and we’ve had over a hundred thousand people from all around the world sign up for it. It’s been great.‌

Harlan Krumholz: So just give me the secret, how do you actually reach a hundred thousand people with a course? I mean, I was really astounded to see that you’d have that kind of reach.‌

Howard Forman: High value and low cost.‌

Harlan Krumholz: And I mean, it’s not a course on the Kardashians or anything like that. It’s actually on drug regulatory reform. I mean, I’m really impressed. I mean, when you went out to do this, did you think, “We can probably reach a hundred thousand people”? I mean, how did you do it?‌

Aaron Kesselheim: No, I mean, we were just trying to develop something because we felt like... Unfortunately, a lot of issues related to the FDA and related to the way that drugs are sold in the United States and the way that drugs are developed are not taught in medical schools and law schools. But we were primarily concerned about medical schools since the physicians who are prescribing the drugs really do need to understand what it means for a drug to be FDA-approved in order to make the best choices and in order to have the best conversations with their patients. And so what we thought we would do is we would develop this online course and then that, we thought, was an easier way of doing it than trying to change the curricula at the 120 or so medical schools in the country. And so that was the sort of impetus for this.‌

And then we collaborated with the folks at HarvardX and developed this really... they were really great at developing figures and graphics and stuff like that. Came together really well. We got a bunch of colleagues and experts to come on and to have interviews and have guests as part of it as well. And it really just came together great. And then I think it is a testament to the fact that this information is so important, and yet there isn’t a lot of independent, non-industry-funded, easily accessible ways of getting it that we didn’t even really have to do that much advertising or promotion for it. We just had to put it out there and people came. So I think it’s been great.‌

Howard Forman: Last question. It’s 20 or 21 years later. Do you still know a good amount about bunions?‌

Aaron Kesselheim: Right, so I do. So what Howie’s referring to is the way that I met my wife. Initially was we were medical students and we met over a patient’s feet in the emergency room at Pennsylvania Hospital in Philadelphia. My wife and I still have a lot of enjoyment over managing whose feet are where and who’s wearing socks and when we’re wearing socks. And so you’ll be happy to know that conversations about feet have remained core to our marriage, and we’ve now passed it on these various feet neuroses to our kids as well. So we’ve got all kinds of slippers and socks and all over the house here, up here in Boston.‌

Howard Forman: We’re going to add it to the show notes because it’s a great story, but I can’t thank you enough for joining us. We didn’t even get to talk about how much you contribute to Yale in continuing to teach our students here, even though you’re at Harvard. So we can’t appreciate you enough.‌

Aaron Kesselheim: Sure. Actually, this spring, I teach... so I do. I teach FDA Law at the Law School and the School of Public Health, and this spring is my 10th year coming down to do that. And I love doing it. The students are great. We have great discussions. It’s a lot of fun.‌

Howard Forman: Great. Thank you.‌

Harlan Krumholz: So great to talk to you. So great to see you again and look forward to seeing you soon.‌

Okay. That was a great interview. I love hearing that’s amazing. That’s crazy. They get a hundred thousand. Their course, Howie, that just gets me, we got to up our game for this podcast and start—‌

Howard Forman: We’re on that way.‌

Harlan Krumholz: We’re on our way. We’re on our way. Okay. Let’s get to one of my favorite parts of this podcast, the Howie Forman part. What’s on your mind this week?‌

Howard Forman: Yeah, so obviously I’ve talked about bird flu a lot, but I’m going to do another H5N1 bird flu update for two main reasons. First, there is a lot to update since our last segment. And two, there’s been a lot of writing about this topic by some thoughtful people, and some of it’s very critical, but none of it is changing my current opinion. So first, a few quick updates. Number one, California, which only had its first case of bird flu in cattle in August and in humans in October, now has the majority. One state has the majority of human cases and the majority of cow herds during this outbreak. There are 57 documented human cases in the United States—California has the majority of them. The good news is that outside of California and Utah, we have not had a reported cattle outbreak in well over a month.‌

So the other areas, Texas, Colorado, Michigan, and so on have not had further outbreaks in over a month. And even Utah is about a month ago now. Every state except for Louisiana has now had a poultry case because Hawaii got added to the list in the last two weeks. And 112 million poultry have been affected, and by “affected” I mean killed, mostly euthanized. There is a young child in California and another one in Canada, both with bird flu, both without obvious exposure to animals. The Canadian child is seriously ill. It is the first critical case that we’re aware of. We don’t know how they got it. California is bulk-testing raw milk at raw milk farms, and it’s had multiple positive samples, and they shut down production when they find these are positive. So those are some really good updates. There are a lot of thought leaders, almost all of whom we know.‌

We know personally, we respect personally, but they are chastising government officials for doing too little. And if you ignore the reality of our times, I think they’d be correct. But short of nationalizing our farms, it is not quite so simple for federal officials to do much without explicit legislation or a declaration of an emergency. Remember that farmers are very reticent to stop doing the work that they do that generates all of their income. And most farm workers are immigrants, and the majority of these are undocumented, which makes this particular population very difficult to get to undergo voluntary testing that could otherwise impair their ability to work or even live in this country. So it’s not a simple challenge. And I want to remind everybody—again, I keep saying it—we still have zero evidence of human-to-human transmission. We do have vaccine available, maybe not enough, but we have vaccine available if there were to be an outbreak.‌

And unlike with the coronavirus, we have antivirals already existing that are likely to be effective in this situation. And we only have one severe case and not even in the United States. For the most part, this is not the lethal bird flu that we’ve observed mostly in Asia occurring periodically over the last two decades, at least not yet. And we don’t want to test this, but that’s what we know right now. So what can and should we be doing? Number one, state authorities should follow Michigan and California’s lead and test more broadly to the extent possible. Wastewater, raw milk, human workers, other individuals with exposure to those who have already been infected and, of course, poultry, cows, and any other animals with symptoms. If we want to wrap our heads around this, we need to know the full scope, and lack of testing is not the answer.‌

There are federal programs that already provide financial support to the states—the support, testing, and surveillance—as well as the farmers. Within the existing law, this should be expanded as much as possible, and Congress should consider legislation during this lame duck session to add support. And yes, the CDC should work on speeding up test resulting in genomic surveillance and tracking. It would be really helpful if we could get results in a few days instead of a few weeks each time.‌

And while this is really beyond my expertise, we should make certain that we have the ability to rapidly vaccinate and/or treat our farm workers, in particular if a human-to-human outbreak or even severe disease starts to be present. Again, it continues to remain possible that we will have a real emergency on our hands in the near future. Just don’t have one right now. And whether it occurs in the next two months or the next 10 years, we should be prepared, but we also can’t be worrying about it and panicking about it at all times. There is zero similarity to Wuhan five years ago when the Coronavirus was clearly spreading. News reports were clearly telling us what was going on in Wuhan at that time. So I’ll just say one more time: We should always heed the advice to be prepared for the worst, but hope for the best. And most of all, not panic at this point.‌

Harlan Krumholz: Well, again, another great update. If this thing turns out to be something, we’ll say you started it. Because you’ve been talking about this, beat this drum a while—‌

Howard Forman: But I don’t want to be the guy... I’m not trying to be the guy that says “I told you so.” I actually think that we are scientists. When things evolve, we’ll change our opinion, but right now, this is what we know.‌

Harlan Krumholz: Yeah. The question is, when does it get to a point where we should start to worry? Because these singular reports, when does it explode? When does all of a sudden thousands of people—‌

Howard Forman: Look, if we test a lot, we’ll be much more likely to find that first human-to-human transmission case, whether it occurs in 2025 or 2035. If we’re not testing a lot, that’s a failure on our part.‌

Harlan Krumholz: Yeah. What I just wonder, if you find it, what are you going to do? We’re not doing lockdowns again.‌

Howard Forman: No, but you could do a more aggressive testing. You could do a lot more treating since we have drugs in advance, and you could start vaccinating people in circles around in those areas that are infected and try to get ahead of it.‌

Harlan Krumholz: Yeah, because everyone’s going to be running towards vaccination. Okay. So especially—‌

Howard Forman: I got that. I got that.‌

Harlan Krumholz: All right. All right. You’ve been listening to Health & Veritas. This is Harlan Krumholz and Howie Forman.‌

Howard Forman: So how did we do? To give us your feedback or to keep the conversation going, email us at health.veritas@yale.edu or follow us on LinkedIn, Threads, Twitter, or Bluesky, where Harlan has recently—‌

Harlan Krumholz: I am recently posting on Bluesky, and we very much want to hear your feedback, questions, anything, experiences. We always try to bring them into the podcast. We appreciate it. Rate us, it helps others find us, and we always love hearing from everyone.‌

Howard Forman: We really do. And if you have questions about the MBA for Executives program at the Yale School of Management, reach out via email for more information, or check out our website at som.yale.edu/emba.‌

Harlan Krumholz: 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 Tobias Liu, and to our producer, Miranda Shafer. They are amazing, and we so enjoy working with them.‌

Howard Forman: We certainly do.‌

Harlan Krumholz: Talk to you soon, Howie.‌

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