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Episode 112
Duration 31:33
Harlan Krumholz and Howard Forman

Another Winter Wave, and Other News

Howie and Harlan discuss the winter wave of COVID-19 and Howie’s experience with the Novovax vaccine, report on potential side effects of the next-generation weight-loss drugs, and unpack the economics of Florida’s plan to import drugs from Canada.

Links:

Sid Wolfe

“Sidney M. Wolfe, Scourge of the Pharmaceutical Industry, Dies at 86”

COVID-19

“Florida surgeon general calls for halt on mRNA covid vaccines, citing debunked claim”

"Safety and Adverse Events Related to Inactivated COVID-19 Vaccines and Novavax;a Systematic Review"

“Paul Offit Debunks Florida Surgeon General's Anti-Vax Warning”

“Does Novavax's Covid vaccine cause fewer side effects?”

“SOTP: State-of-the-Pandemic: The pandemic's 2nd biggest wave of infections and what the JN.1 variant is telling us”

“Deaths induced by compassionate use of hydroxychloroquine during the first COVID-19 wave: an estimate”

Weight-Loss Drugs

“FDA looking into reports of hair loss, suicidal thoughts in people using popular drugs for diabetes and weight loss”

“Semaglutide and risk of suicidal ideations”

“January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)”

Elevance and Medicare

“Elevance sues HHS over Medicare Advantage star ratings”

“How the Tukey Method Could Impact Star Ratings”

TriNetX: Explore. Discover. Connect

Large Language Models

“Diagnostic Accuracy of a Large Language Model in Pediatric Case Studies”

“Artificial Intelligence and Machine Learning in Clinical Medicine, 2023”

Drug Imports

“US FDA to allow Florida to import cheaper drugs from Canada”

“FDA approves Florida's request to import cheaper drugs from Canada”

“Price-Fixing Case Reveals Vulnerability of Generic Drug Policies”

June Jackson Christmas

“June Jackson Christmas, Pioneering Psychiatrist, Dies at 99”


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 both together in the studio today, which is—

Harlan Krumholz: Great to see you, Howie.

Howard Forman: It is rare for us to do this, and it’s sort of fun to do it. It’s good—

Harlan Krumholz: It’s a special episode.

Howard Forman: ... to see you live. This week we’re going to talk to each other about a host of different topics. We don’t have a guest. That’s why we decided to do it in the studio today. And we both knew Sid Wolfe. I think you knew of him better than I did, but I think you wanted to speak to just what this man represented and what he accomplished in a life well lived.

Harlan Krumholz: Yeah. I just wanted to take a moment to give a tribute to Sid Wolfe. People listening may have heard that Sid Wolfe passed away at age 86 recently of a brain tumor. Who the heck was Sid Wolfe? Well, Sid Wolfe was a doctor who turned into a consumer activist, who really spent his life surfacing issues that, in my view, needed to be discussed, where he was concerned about issues around drug safety.

I mean, he was one of the early ones that really weighed in about Vioxx as that controversy came up. And really, he was one that was trying to help ensure that the public’s interest was being served by all the forces around us that may sometimes be pushing either a little too fast or overlooking some things. There are people who felt that Sid was a zealot, but honestly, we needed a voice that was loud and clear, that would stand up to the powerful and raise uncomfortable questions.

Howard Forman: Yeah. I was fortunate to bring him here probably 18 years ago to meet with my students, and I was very impressed with him. I think the term zealot can be used in a positive or a negative way. I don’t think zealotry is always bad. I think zealotry is bad in people that have a lot of power. But when somebody believes in something, to have zeal is not a bad thing. And he had zeal. He was very committed to this cause that we needed more equitable, safe access to pharmaceuticals.

Harlan Krumholz: Yeah. And on odd times, I would get a call from Sid—always, they were welcome calls. He always raised important issues, sometimes trying to utz me to do something that maybe I hadn’t realized that there was an issue to be faced. Yeah. I mean, he had both people who admired him and detractors. I fall into the admiration side. I really thought that he was a guy who really sought to do the right thing. And again, was he on the right side on all issues? Hard to tell, but, nah, he made a big contribution to American healthcare.

Howard Forman: I share that sentiment. I didn’t know him as well as you, but having had him here, he was as I would say, a mensch, which was—

Harlan Krumholz: Yeah, he was a mensch.

Howard Forman: ... the best thing to say.

Harlan Krumholz: Definitely. So Howie, what else do you want to go to today?

Howard Forman: Yeah. So we talked about COVID last week, last episode briefly, but there is some recent news on COVID, and I just wanted to get your take on some of this. One of it is, and I almost hesitate to mention it because it seems political and it shouldn’t be, but the Surgeon General of Florida, Ladapo, Dr. Ladapo, a Harvard-trained physician, a very, not just well educated but very successful physician before he went into the public domain, he wants to halt the use of mRNA vaccines in Florida. He’s made a call for it predicated on the fact that he believes that the DNA fragments that are found in the vials are potentially going to alter your genome. One of our friends and colleagues has a nice video online of saying, “This is absolute bunk.” He goes through exactly why it’s bunk. Ashish Jha more simply said, “This is just pseudoscience. I can’t believe he’s saying this.” But I was curious if you had seen this and what you think about that? And how do we move forward at this point?

Harlan Krumholz: Yeah. It can be quite confusing when a public figure comes out and says something so authoritatively and definitively in an area where the science hasn’t really emerged. It’s bound to confuse folks. Look, I think it’s true that these vaccines saved millions of lives. I also think it’s true that these vaccines may have caused harm in some people. We’re learning about that. But what he’s talking about is actually something very different, and it doesn’t have a scientific basis at this point. And it’s unfortunate because it’s not being driven by how the evidence is going, and really, it feels more political. I was interested though, Howie, in the last episode, you said you were seeking the Novavax.

Howard Forman: Yeah.

Harlan Krumholz: What made you make that choice?

Howard Forman: So I’ve had a number of vaccines in my life. I’ve had flu vaccines. I’ve obviously had all the childhood vaccines. I had the Shingrix vaccine—one dose, not both. And I have very high reactogenicity side effects from Shingrix and then from all the mRNA vaccines, both Pfizer and Moderna, not so much that I wouldn’t get vaccinated, but it was causing me to have a headache for like 48 hours and the usual fatigue that people experience. I started doing some reading, and a few people that I really respect on Twitter said the evidence is Novavax is at least as effective and maybe, not necessarily, but maybe less reactogenic. People may have a lower side effect profile.

So I figured I’ll take advantage of the placebo effect, even. Even if I think it has less reactogenicity, why not try it? And lo and behold, it’s the first time that I’ve taken one of the COVID vaccines where I didn’t have chills at night. I had no measurable fever. Very mild headache the next day that went away. And so I’m happy I took it. I believe in the science. I think one of the points you made when we’re talking about Ladapo is even the harm that we know about with the COVID vaccines right now is vastly dwarfed by the benefit from it. And I take that very seriously. I think when I think about my risk-benefit profile for taking either of those vaccines, it vastly favors getting vaccinated.

Harlan Krumholz: Yeah. And I mean, my concern is... and for folks listening, what you’ve just described is an anecdote. I mean, there isn’t a published article that makes clear that the Novavax has a lower—

Howard Forman: There is one published article, I’d have to go find it, one published article that says the reactogenicity may be lower.

Harlan Krumholz: Maybe. Maybe. Anyway, it’s not clear. But my concern is as we look across the country, there’s still very few people who have been vaccinated for COVID.

Howard Forman: So I looked up the numbers for us. 19% are now vaccinated and only 37% of those over 75.

Harlan Krumholz: Yeah, yeah. So this is a major concern of mine, which is that those at risk ought to be vaccinated.

Howard Forman: I agree.

Harlan Krumholz: They’re basically leaving themselves unprotected, and I think that that’s unfortunate.

Howard Forman: Yeah. I think the other problem is that early in the pandemic, we were telling people who were recently infected two months ago, “You should get vaccinated.” And that may or may not have been correct. I don’t know enough to say that either way for sure. But the one thing we know right now is that immunity wanes, whether it’s from prior infection or from prior vaccination. And so at this point in the pandemic, there is a vast number of people over 75 who are very much vulnerable to this new variant. And vaccination clearly has a favorable risk-benefit profile for them.

Harlan Krumholz: Yeah. Eric Topol put out, I thought, a really nice state-of-the-pandemic piece recently. He was sort of describing other people’s work and really, I think, putting into bright relief the idea that we are in the midst of the pandemic again. And there was something he quoted that says, “As of December 30th ... there were 1.6 million new infections per day.” We talked about this last week. So many people around us are infected. And unlike the experience even in recent months, it seems like this variant and this wave is causing a lot more distress. People could get a lot sicker, hospitalizations to increase in ways that we haven’t seen for a while. So another reason why people should be protected. And it may be that we’re in a bad direction right now with regard to it.

Howard Forman: Yeah, yeah. Did you happen to see, there’s a study that came out from a group in France who looked at six countries, including the United States, and they did a analysis of the marginal effect of hydroxychloroquine? And they have convinced themselves, maybe not everybody at this point, that there was an excess number of deaths just in those six countries of 17,000 associated with hydroxychloroquine use, suggesting that the side effects of hydroxychloroquine, perhaps the cardiac ones, might actually be much worse than we thought in this large population.

Harlan Krumholz: Yeah. I always find those studies to be challenging. I mean, in a place where people are more likely to take hydroxychloroquine, maybe other behaviors also track with that.

Howard Forman: That’s right.

Harlan Krumholz: I think what we can say for sure is that there never emerged any strong evidence that this—

Howard Forman: That it helped.

Harlan Krumholz: ... is beneficial. Same with ivermectin. And yet how many people do we have in this country that were not willing to take vaccines but were willing to take these other medications, which, by the way, are not harmless?

Howard Forman: Right.

Harlan Krumholz: So whether or not that study’s true, what is true is that these aren’t harmless medications, and yet there was never really any evidence that they could provide benefit.

Howard Forman: I couldn’t agree more.

Harlan Krumholz: And how is that, Howie? I mean, that whereas so much of the population can grab hold on to misinformation about a drug and be willing to expose themselves to the risk of that drug. Meanwhile, we have tons of evidence about highly effective strategies and people were reluctant to embrace it.

Howard Forman: I mean, we live in a time right now like no other in my lifetime, where your tribe, who you affiliate with, what political party you affiliate with, what TV shows you watch, what radio shows, what feed you have on social media is going to be far more predictive of your logic than anything else.

Harlan Krumholz: Yeah. I’ve been really influenced by these articles I’ve been seeing, talking about the rabbit holes with regard to social media, that you get on TikTok and it actually creates a personal path that starts to amplify the messages that you’re getting that can be getting bizarre, more bizarre and more bizarre, sort of incrementally pulling you into a—

Howard Forman: No question.

Harlan Krumholz: ... ecosystem where you think the whole world believes x, y, or z.

Howard Forman: Yep. No, I mean, there are times where I will try to follow up on a conspiracy theory, and there’s a certain point where you’re like, “This is starting to sound plausible. Let me leave this echo chamber—

Harlan Krumholz: Ecosystem.

Howard Forman: ... right, and go find a completely different source because that may pull me back.” And it usually does, but it’s worrisome.

Harlan Krumholz: Yeah.

Howard Forman: On the same note, Harlan, of “How do we look at studies?” you and I talked about the fact that the FDA has flagged three potential side effects associated with GLP-1s. Those three side effects, just for our listeners... and by the way, when we say “flagged,” there’s the beginning of a signal, meaning that they’ve just seen reports. It may absolutely not be true. The three are suicidal ideation, aspiration during surgery, and alopecia, which is unusual hair loss. By the way, the aspiration during surgery at least sounds physiologically plausible because we know that these patients have sort of a paralysis of their stomach, which can lead to reflux of stomach contents during surgery. The others are harder to explain, but we don’t know enough about the GLP-1s.

These are the glucagon-like peptide agonists, and we don’t know enough about them. We do know they’re highly effective with weight loss, highly effective for diabetes. But I bring this up because I asked you a question about a study in Nature that, within days of the FDA report, reported on a study that they had started well before that that said suicidal ideation is actually reduced with GLP-1 use. And I’m personally confused about it because I don’t know if I should believe this for the same reasons why you said to me the hydroxychloroquine study, you’re not sure. So I’m curious your thoughts on that.

Harlan Krumholz: So let’s just get back to the major headline first, which is the FDA flagged this, as you said, but it doesn’t mean they’ve found it. It means that they’re looking into it. But this will still unsettle people, particularly people who are taking these medications and people who are considering them. And so there’s going to be a lot of interest in this. We’ve said the trials are studying tens of thousands of people, but as millions of people start to take a medication, side effects can emerge that—

Howard Forman: You don’t expect. Right.

Harlan Krumholz: ... aren’t detected in the early part of evaluation. One strategy people are taking is to use some of these large datasets. In the case of the study that you mentioned, they’re using a platform called TriNetX Analytics Platform. What this does is, this company goes into health systems and says, “We’d like to be able to use your data to commercialize it for other purposes, whether it’s selling to pharma or for a wide variety of commercial purposes. And in exchange, we can help you to be able to delve into your own data and get insights.” And so they make some sort of contract. By the way, I brought this up to you before, if I want to use the Yale data for research, I’ve got to go through all these hoops. These business contracts basically can go and make a business contract with the healthcare system and get access to all of their data.

Howard Forman: And what about me? I’ve been a patient at Yale New Haven Hospital many, many, many times. Do they have access to my data?

Harlan Krumholz: There are many business associates who have access to your data through agreements with Yale New Haven Hospital. I don’t think Yale New Haven has an agreement with TriNetX, but—

Howard Forman: Okay. But they could.

Harlan Krumholz: ... they could. They could. And they often do. So then they have this platform, and one of the issues is that they can’t tell you where the data is from. That is when they publish things about it, in order to maintain the agreement that they have, they don’t really quite tell you. They say, “These come from 100 million patients, from 59 healthcare organizations across the 50 United States,” diverse geographic regions, age, ethnicity, and so forth, but they don’t tell you who these hospitals are. It’s a mystery dataset in that way. And then they go on to say that the data has been pre-processed. They’ve gone on and done things to it so that it can be analyzed. But some of this is really, you’re not clear exactly what they did do.

And then what they did was they took a large number of these people who had been taking these medications compared to people who hadn’t. They did some usual statistical techniques to try to determine who had the outcome and whether there was additional risk. I don’t know, Howie. I mean, I think we got to see whether this validates in other datasets. But I guess the thing I can say is in this study that there wasn’t a signal of harm and, if anything, safety. And in my own experience with patients, I think this thing treats depression. I mean, people who are facing obesity, once they can finally in their life get control of that obesity and lose weight, actually their mood often will elevate.

Howard Forman: Right. But there’s several layers to that, right? So the one question is, is there a central mechanism that lifts your mood, or is it that immediately you see yourself losing weight, which gives you hope, and hope does lift your mood? So I know it may not seem like a big difference to other people, but the reason why it matters to me is you could simultaneously have a central mechanism that could lead to suicidal ideation, as we see with antidepressants, and simultaneously have your mood lifted because your weight is going down, and both things can interact.

Harlan Krumholz: Well, and for the patient, it may not matter what the mechanism is, but I think your point is a good one. Lots of people are thinking about these drugs as having the potential to rewire your—this sounds wild—

Howard Forman: Yeah, I know.

Harlan Krumholz: ... but there’s some brain rewiring that’s going on because it’s affecting your satiety centers. And we’ve heard lots about maybe addiction goes down. I mean, there are things that are happening, I think, beyond what we really understand. And there is this relationship between what’s going on in the brain and what’s going on in the stomach and in the rest of the body.

Howard Forman: And just for our listeners, a lot of things can rewire our brain, right? Exercise can rewire our brain.

Harlan Krumholz: Yeah, yeah, yeah. So it’s not implausible that this could be having effects that could be untoward that relate to behaviors. We definitely need to monitor for it. I just don’t think we’re in any place now to say that actually is what’s happening.

Howard Forman: Yeah. No, no, no. I really appreciate you talking about that because, to me, we have one study that’s saying a very bold thing, and then you have the FDA issuing a statement, which is almost the opposite.

Harlan Krumholz: But it was a reassuring study that came out, no question about it.

Howard Forman: Yes, it certainly doesn’t make the case worse.

Harlan Krumholz: Yeah. So one thing I wanted to ask you about today was it turns out that Elevance, which is a payer, is suing the federal government about the way that they rank health plans because it has tremendous financial implication on it. And then they’re talking about esoteric statistical methodology in this. I don’t know, what’s your take on that?

Howard Forman: So I brought this up to you, and I said, “I want your take on it,” because when I read it, what’s funny to me is here you have this very, very well-capitalized rich company in the health insurance space. Elevance, for those of our listeners who may not know, is the former Anthem. It’s the former Blue Cross Blue Shield of New York and California, a bunch of places, and now it’s called Elevance. And they have tremendous wherewithal to sue the federal government when rules don’t go their way. And so there’s this thing called the Tukey deletion, which allows them to modify a dataset to make it what Medicare thinks is a more normalized dataset. And I think it goes against the profitability of Elevance.

Harlan Krumholz: Well, yeah, I mean, the methodology that they employed. So this “Tukey” is from this guy, John Tukey

Howard Forman: Who was that?

Harlan Krumholz: ... who was a famous mathematician at Bell Labs and at Princeton. And for those of you who are aficionados of math, I mean, this guy was responsible for fast Fourier transform—

Howard Forman: Oh, wow.

Harlan Krumholz: ... box plots, the Tukey range test. There’s a whole Tukey correction for statistical significance. I mean, he’s done a lot of stuff. I mean, this guy’s one of the most esteemed mathematicians that we’ve had. He died in 2000 at age 85 after making immense contributions. But one of the things he did was he came up with this way of identifying and excluding an outlier within a data set so that it wouldn’t have untoward influence on the result. And CMS thought, “In order to make sure that our findings are stable year to year, we don’t want one outlier, one that’s really very different than the others to be sort of influencing where our thresholds are for being able to say there is reward or penalty.”

Howard Forman: Right.

Harlan Krumholz: And so they thought, “This seems sensible to do.” I guess Elevance’s methodologists looked at it and said, “Because you did it that way—

Howard Forman: “It hurts us.”

Harlan Krumholz: ... that put us in the penalty zone or put us in a disadvantage, and we want you to get rid of it.” This is the kind of thing where it shouldn’t be based on what the results are. People should be looking at it a priori and trying to decide what the best approach is. It’s just interesting that this is now being brought into public policy.

Howard Forman: It is fascinating. I mean, it’s just not surprising in our capitalist economy that this is how it functions. You can’t get away from that.

Harlan Krumholz: I don’t know if you want to just hit on one more substantive area, which is this article that came out in JAMA Pediatrics this week.

Howard Forman: Oh, yeah. No, definitely. Yeah.

Harlan Krumholz: Just to say that it was just questioning the diagnostic accuracy of large language models in pediatric case studies. I thought this was interesting because we’ve seen so many studies come out that say these new AI, artificial intelligence models can pass the boards. They can solve difficult cases. There was a recent study that came out and said that differential diagnosis can be done well out of Google Research and Google DeepMind. There was another one that came out that was saying that... there was an article in New England Journal of Medicine Artificial Intelligence. It said it can solve a lot of complex cases that might appear in the New England Journal too. And yet this one said that it was not doing a very good job for pediatric cases.

I’ll just say my quick take on this is we’re in the first half of the first inning of this thing. So these things are continuing to get better and evolve over time. It’s sort of like taking a snapshot today is wholly inadequate. It doesn’t surprise me that the methodology of these studies are slightly different. What I do know is that when you put this head to head with a person in a room and you ask them, “What does this do?” these large language models do pretty well. And when you do it as an additive clinical decision-making support—

Howard Forman: Assistive. Yeah.

Harlan Krumholz: ... assistive, it helps people, right?

Howard Forman: Yeah.

Harlan Krumholz: So I’ve been bringing this up all the time. It’s like the pilots in the cockpit. I mean, I think that these things can be helpful. But yeah, I’m not ready to declare a verdict based on one study.

Howard Forman: I’m becoming more convinced that this is going to have one of its biggest impacts on medical education, because I think that if we can get confident in how people can access this information, we could spend a little less time fixated on some of the memorization parts of medical education and really stick to the way to think, the way to find information rather than exactly what you have to have memorized in order to pass a board’s exam.

Harlan Krumholz: Well, and I think this will raise the question, what does competency represent in medicine anymore? Is it sitting for an every-10-year test where you had to be prepared to have memorized the answers? Or are we going to evolve to a different era?

Howard Forman: Open book. Open ChatGPT. Why not? If I can answer the question in 30 seconds by looking it up, is that any worse than what real life is like?

Harlan Krumholz: Yeah. So I think this will undergo a dramatic, dramatic change.

Howard Forman: Okay. So here’s an interesting thing that I feel like I’ve been following almost my whole career, because when I was working in the Senate during the Bush administration, it was the first time that President Bush, I believe, or maybe it was Congress, but somebody passed a law or executive order that said states can reimport from Canada as long as the FDA says it’s okay and safe. And so for the next 20 years, the FDA did not say it was okay or safe, but people have continued to lobby or apply to the FDA in order to be allowed to reimport drugs from Canada.

Now, why is that important? Canadian drugs are a fraction of the price of the same identical American drugs, same identical drugs at a fraction of the price. And people that live on the border can legally cross the border. If you live in Vermont, you can legally cross the border, buy your drugs there, come back to the United States, and not only have paid for your trip, but saves a lot of money on top of that, which is just an unfortunate indictment of the U.S. healthcare system.

The Florida Department of Health applied to the FDA. They came up with a plan for how they want to do this. Basically, for their Medicaid programs, their prisons and their state-run clinics, they want to import drugs from Canada. And for the first time, the FDA has given an approval for that. It may not be as easy as it sounds because you still need the compliance of Canada. The drug manufacturers and Florida has to come up with a specific plan that the FDA would then approve. But we’re pretty far the way there. And so it’s interesting that we’re watching this go down the street right now, and see whether it eventually is able to take off.

Harlan Krumholz: Well, I think this is a really important event because, first of all, Florida says it’ll save taxpayers about $150 million a year just by simply importing from Canada as opposed to buying.

Howard Forman: And just for the subpopulation. It’s not even the—

Harlan Krumholz: Just for the subpopulation.

Howard Forman: Yeah.

Harlan Krumholz: So I wanted to ask you, why aren’t all the states applying for this?

Howard Forman: Yeah. So first of all, there’s dozens of applications out there for it. Florida, I think, is just the one that did the best job of figuring out how to apply. But I think if we had all states doing it all at once, it would be a no-brainer for Canada to immediately put up a wall and say, “We can’t do this. We’re a country of 40 million people. Florida alone is a state of 21 million people. It’s almost impossible to service them without obtaining more drugs from drug companies. And those drug companies simply won’t sell us that many drugs. And we don’t want a shortage for our own people.”

Harlan Krumholz: So help me understand this. I mean, in one article I read it said that, for example, in the UK, they pay about, I don’t know, $300 per capita for meds. In the U.S., our use of medicines is not so different, and we pay about $1,100...

Howard Forman: Sounds about right.

Harlan Krumholz: ... per capita for medicines. I mean, how is it that we end up paying so much more for medications?

Howard Forman: We have very few areas where we allow the government to use its heft to purchase drugs.

Harlan Krumholz: It’s purchasing power, huh?

Howard Forman: And really, the VA is one example, and there’s a few other limited examples, but they certainly don’t have the heft of Medicare, which we’re going to start to see with the Inflation Reduction Act, maybe. And they don’t have the heft of a state of Florida, for instance, to try to do this all at once. Quite frankly, we’ve supported an industry because we’ve been afraid to over-regulate it and impair innovation. It remains to be seen how much impairment of innovation might occur if we were to ratchet down prices. And we’re going to start to see that with the Inflation Reduction Act.

Harlan Krumholz: Well, here’s a question for you. Do you think that the drug companies are losing money at the price point that they have in Canada?

Howard Forman: No, I don’t think so. I think they actually are at least capable of making marginal cost of the drugs.

Harlan Krumholz: So I’m just saying if there is a profit that’s being made in the other countries at the price points that they’ve had, then we’re really subsidizing large profits there.

Howard Forman: 100%. My former student, who you know I won’t say his name here, but my former student, his paper, 1998, in my class was “The Free Rider Problem of Canada on the United States.” And to this day-

Harlan Krumholz: Not just Canada, though.

Howard Forman: Right, right.

Harlan Krumholz: Right?

Howard Forman: But to this day, I believe that’s true, that a lot of these countries free ride on our R&D.

Harlan Krumholz: So do you have a prediction for 2024 with regard to this importation issue?

Howard Forman: So I mean, I have predictions on both these issues. I think the importation won’t happen. I think it’ll be stalled because I think it’s going to take a lot of regulatory. The FDA is going to have to approve... remember, they have to re-label every box when it comes back over. Lots of things have to happen. I think it’ll get stalled. I think the drug companies will tell Canada, “We’re not giving you an extra dose. We know what you need. You’re not getting it.” And they’re going to be afraid to give anything to Florida. So I think there’s a lot of reasons why it probably won’t happen.

The thing I worry most about this year is whether the Supreme Court or any of the courts rule against the Inflation Reduction Act because I happen to think that is a great start. I think we really do need to negotiate on the margin. All these drugs will have made billions of dollars before we start to ratchet down the prices on them. I think that’s an appropriate action to take.

Harlan Krumholz: Are they considering cases that are specifically about the drugs, or are they seeing larger scale or cases in other areas, but that will knock down the Inflation Reduction Act so that the drugs will be a casualty of that?

Howard Forman: Yeah, I think it’s called the Takings Clause. They’re attacking the ability of the federal government to actually lay claim to a price imposition.

Harlan Krumholz: So it is about the price fixing of the drug—

Howard Forman: Yeah, it’s about the price fixing.

Harlan Krumholz: ... of that?

Howard Forman: And it’s by several different mechanisms and several different lawsuits. They’ll eventually, I think, get consolidated. We should probably get a health lawyer who deals with this. Maybe Nicholas Bagley or someone else will get on at some point to just talk, or Aaron Kesselheim, to talk more about the legal aspect of it. But this is going to be fought in the courts first at the federal court level and then working its way up through the appellate and Supreme Court.

Harlan Krumholz: Does this include the insulin pricing, the cap on insulin?

Howard Forman: So I don’t think there’s a lawsuit about that, I think partly because the drug companies sort of conceded on a lot of that even before the executive order took effect.

Harlan Krumholz: I see. Great. Howie, take us home. You have one final thing, I think.

Howard Forman: Yeah. So you started with Sid Wolfe, and I was very young when I was in my seven-year medical program, and I had a professor named June Jackson Christmas. You don’t forget a name like that. She was a behavioral health psychiatrist, taught us. She was quite fine, and I knew she was a senior psychiatrist. I didn’t know a lot about her, and I’m sort of ashamed now all these years later because she died on New Year’s Eve, and I got to read about her. And it was so touching to learn about her. I just want to tell our listeners a few things about her because she was a woman well ahead of her time. When she was 14 years old in Cambridge, Massachusetts, she staged a sit-down at a roller skating rink that was segregated. I mean, think about that, 14 years old in like 1938, I’m guessing—

Harlan Krumholz: Wow.

Howard Forman: ... or ’39 she did that. And it never stopped. Her activism never stopped, her commitment to equity. Her accomplishments only grew from there. She became the head of the New York City Department of Mental Health and Retardation Services, that’s what they called it, under Mayor Lindsay, Beame, and Koch. I’m a New Yorker, so I know all three of those names because that’s in my lifetime. She went to Vassar College. She was, I think, the third Black woman to graduate from Vassar. She went to BU Medical School and eventually became a psychiatrist. She was the first Black woman to serve as the head of the American Public Health Association.

Harlan Krumholz: Wow.

Howard Forman: I just didn’t know how extraordinary she was at those times. I want to give you two quick quotes that just touched me. One of them is a quote apparently that is part of lore, and that is, “Each one teach one,” which is rooted in American slavery when Black people were denied an education and literacy was conveyed from one person to another, that this is the way you had to change the world.

And the other was a quote that she gave really in preparation for this obituary, because I think it was only seven years ago. She said, “It seems to me that I’ve often been in places where if you wanted to make life better for yourself, you had to work to make life better for everybody else.” And I just was so touched by that. That is one of the most well-lived lives. And I’m again embarrassed that I didn’t know enough about her in her lifetime. I hope more of our listeners will go back and read the New York Times obituary and learn more about June Jackson Christmas.

Harlan Krumholz: That’s wonderful. Thank you so much for sharing that, Howie. 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, you can still email us at health.veritas@yale.edu, or you can still find us on various social media, LinkedIn, Threads, and Twitter or X.

Harlan Krumholz: Yeah. We’re still calling it Twitter, @hmkyale. That’s hmkyale.

Howard Forman: And I’m @thehowie. That’s @thehowie. Aside from Twitter and a podcast, I’m 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 for more information on our innovative programs, 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 to our producer, Miranda Shafer. Terrific, terrific folks.

Howard Forman: We’re lucky to have them.

Harlan Krumholz: We’re lucky to be working with them.

Howard Forman: Yeah. And we got them for another year at least, unless they get scared off by us. So they’re with us when they’ll be seniors next year.

Harlan Krumholz: They’re students. And I hope Miranda’s with us longer. Talk you to soon, Howie.

Howard Forman: Miranda’s going to be with us forever. Yeah.

Harlan Krumholz: Talk to you soon.

Howard Forman: Thanks very much, Harlan. This was a lot of fun. Talk to you soon.