Ruth Katz: Crafting Landmark Legislation

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

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. We’re excited to welcome Ruth Katz today. But first, we always check in on current hot topics in health and healthcare, and there’s a lot to choose from, Harlan. So what do you got for us today?

Harlan Krumholz: Oh, there’s a ton out there, Howie, right now. I wanted to pick one that was one of my favorites that came out this week, that paper that was called, “Grilling the Data: Application of Specification Curve Analysis to Red Meat and All-Cause Mortality.” That highfalutin title—

Howard Forman: Oh, that sounds so simple.

Harlan Krumholz: That highfalutin title actually is pretty simple and straightforward, and it builds on work that has been done primarily in the social sciences that has looked at the reproducibility of science—the reproducibility of science. This turns out to be a big thing because there are a lot of false positives in our scientific publications, meaning that people make claims, “Oh, I found this, I found that,” and then over time, it really can’t be validated. It’s not reproducible. And so people are wondering, “What I can trust?”

And it turns out that this isn’t just because people are trying to mislead readers or journals or that people have done anything wrong. It turns out that well-meaning, highly skilled investigators, given the same database but using different analytic approaches, reasonable analytic approaches, defensible analytic approaches, can actually come up with different answers. And so this is something we should be embracing, not running from, but we need to recognize it as a potential threat.

There was a famous article written by a friend, Brian Nosek, I think I’ve mentioned it here before, where they were trying to enlist a whole bunch of experts around the country to take a dataset from soccer matches and determine whether there was a bias in who got red cards, who the referee flags as doing something wrong, even potentially kicking them out of the game, and to say, “Are they biased by race?” And they had all these expert groups look at it a whole bunch of different ways using defensible methods. And honestly, there was a big spectrum of findings. Some people finding absolutely there’s bias, and other people not finding it at all.

And so this group in this paper took a very similar approach to the studies that have been conducted asking the question whether or not red meat causes cardiovascular risk—really, the effect of diet on health. And what they did was they looked at all the papers that had been written and cataloged a whole bunch of different methods that could be employed. And then they took a single database, a public database, a federal U.S. database, NHANES, and they applied this long list of statistical approaches, all of which were defensible, and saw whether they would get a consistent result or not.

And here was the fascinating part, Howie. They looked at, believe it or not, 1,208 unique analytic specifications. What that means is that they ended up with more than a thousand different ways that you could do this, all that they felt were defensible. And 36% yielded a result that said that red meat caused an increase in all-cause mortality, and 64% said that it was actually protective for all-cause mortality. Now, most of these were not significant, but they did in fact identify a small number, about 4%, where there was a statistically significant indication of increased risk, and they also found that there were a bunch that found decreased risk, and that their overall inference was that it really wasn’t strong evidence either way.

Now, you know it’s hard to do these observational studies of nutrition, and the fact that there was no effect still doesn’t tell us whether or not meat is dangerous or not. But what it does say is that it may be that there are a lot of people out there trying a lot of different analytic approaches, and when they get one that’s likely to get headlines, they seize on it and they end up writing a paper around it, and it ends up giving a false perception of the strength of the evidence in the literature.

And I thought what was so important about this, one was there’s a sidelight, which is saying, “We really don’t even know about meat anymore. And there’s not, if you look at the evidence, at least from this federal database, strong evidence of risk.”

But the more important thing was that we need to be able to find ways in this observational research where we are not conducting an experiment, but we’re observing over time what happens to people and trying to draw a conclusion about, for example, diet and health, that we need to be applying many different methods and reporting them all, not just cherry-picking one that looks good or one that looks bad. And journals need to be demanding that really we see a more comprehensive look if we want the work ultimately to be reproducible and not to be how easy it is to game it if, of all those different ways you did it, the only one you reported was the one that everybody would be amazed at and gasp at and newspapers would write stories about and journals like because people are going to quote.

Howard Forman: It’s fascinating, and I will say very personal for our family because my father stopped and my mother stopped eating red meat in like 1982 when my father had a heart attack. And that has been sort of dogma for our family for more than four decades right now.

Harlan Krumholz: Well, I’d do the same. And by the way, if you ask me, I still think it’s a good idea, honestly, but it’s not... the emphasis—

Howard Forman: Yeah. So you’re telling me my parents don’t have to run out and get some steak tonight?

Harlan Krumholz: Well, I’ll only say—aren’t your parents doing well?

Howard Forman: They are doing very well. They are doing very well, thank God.

Harlan Krumholz: Well, which I’m grateful for, but I’m saying that the evidence here in nutrition is not as strong. But importantly, I’m saying that the way you do the research, even in highly defensible and legitimate ways by good investigators, can actually produce different findings. Something to watch out for.

Hey, let’s get to Ruth Katz, one of our favorites, for the interview section.

Howard Forman: Ruth Katz is the Executive Director of the Health, Medicine & Society program at the Aspen Institute, an educational and policy studies organization where she’s also a Vice President and the Director of Aspen Ideas Health. Before joining the Aspen Institute, she served as Chief Public Health Council with the U.S. House Committee on Energy and Commerce working on the Affordable Care Act from 2009 until its passage, as well as much, much more, which we’ll get to.

She was Dean of the Milken Institute School of Public Health at George Washington University from 2003 to 2008 and Associate Dean for Administration at Yale University School of Medicine from 1997 to 2003, which is when Harlan and I first met her. Katz graduated magna cum laude from the University of Pennsylvania, holds a law degree from Emory University, and holds a master’s of public health from Harvard.

And before I actually just welcome you to the podcast, I want to just go off-script and say I met you and I invited you to teach my undergrads, give a class to them about 21, 22 years ago. And I will say that every student in that room, their eyes were wide open, excited, but I was probably the most excited of all. I had never been as inspired by any speaker in any class in anywhere than I was by you because you are one of the most passionate, compassionate public health officials and leaders that I’ve ever met.

And so I want to allow our audience to get some sense of that. And I want to start off because you’re sitting in your office—

Harlan Krumholz: Well, wait a minute, Howie. Can’t I jump in here and just say how amazing Ruth is also?

Howard Forman: You can. Why don’t you do that? And then I’ll... yes.

Harlan Krumholz: Just an extraordinarily unsung hero, someone who has had her fingerprints on so many good things that have happened in our nation but has just never put herself in the limelight, has always stood back and just made things happen. One of the most effective human beings I’ve known. One of the best decisions I ever made was to invite her to be part of the Clinical Scholars Program, and it was really as much for my learning as it was for any of the scholars. I mean, she’s just a remarkable role model. Just want to just chime in that.

Howard Forman: And nothing we can say will actually match what you are, so let me just say that.

But I want to start off because you’re sitting in your office and you have these plaques behind you that represent legislation that you’ve worked on, and I would love to hear you just briefly explain why these two are important to you and how they fit into your career arc as well.

Ruth Katz: Howie, what’s hanging on the wall in my office at home are indeed two framed sets of legislation that I worked on during my time on Capitol Hill. The most recent one is what’s called the redline version, which is a special edition of legislation that has been passed by the Congress and signed into law by the then President of the United States. In this case, the most recent thing I have hanging on my wall is the redline version of the Affordable Care Act, which I worked on for four years.

Right above it is a redline version of legislation that I worked on to authorize the work of the National Institutes of Health. This was back in 1993, which included very groundbreaking, if you will, provisions related to women’s health. It was the first time, for example, that women were and still are required to be part of clinical trials that the National Institutes of Health funds. It also had legislation related to some special research involving fetal tissue transplantation research.

Why are they important to me, to get to your question? I worked for a total of about 18 years on Capitol Hill. I had two different stints and I think these two pieces of legislation, and I worked on lots and lots of important stuff, but for me personally, for so many reasons were most gratifying, not the least of which is that while working on Capitol Hill, especially in all kinds of ways, not every person who works up there gets the opportunity to be part of a piece of legislation that literally comes around once every generation. And that was the truth with the Affordable Care Act. People have been trying to enact health reform legislation for over 40 years. I was fortunate enough to be part of the effort that finally made it happen. And similarly, the legislation back in 1993 regarding the National Institutes of Health included some very important provisions that we’ve been working for in a long time.

So for me personally, they represent major pieces of work that I was able to participate in, and I get to look at them every day and remember why it was such a special time for me.

Harlan Krumholz: Ruth, I want to jump in quickly to another contribution that you made regarding vaccine injury. And I just raised it because I’ve found myself in a position where I’m working with Akiko Iwasaki with patients who are reporting that they’ve had some devastating injuries as a result of the COVID vaccine.

Now, and I’m on record saying this, I believe the vaccine saved millions of lives. I also do believe it’s possible that a vaccine can save millions of lives and also for some people to have adverse effects. We’ve seen this in many others. These people have been sort of ostracized. They’ve been sucked into the political process. They’re words have been weaponized. They’re just wanting help.

And I wonder if you could just give a little insight from the history because this isn’t new that we have vaccines that are helpful but can harm.

Ruth Katz: It is not new at all. This is legislation that goes back that I worked on, National Vaccine Compensation Program, which is designed to provide a no-fault system, just like we have no-fault divorce laws, no-fault automobile accident laws, to provide a no-fault system for individuals who were injured as a result of doing what I think you guys would agree is their public health duty to get vaccinated, not only to protect themselves but to protect the public at large. Our view was if you do your public health duty and you are injured as a result, and Harlan, you are absolutely correct, no vaccine is absolutely perfect for every individual, there are people who are injured by them, although not many, that we ought to compensate them for the harm that they incur.

And the program was actually developed as a result of our concern of the small number of U.S. manufacturers of vaccines back in the day. When we worked on this legislation, for example, we had only one manufacturer of the polio vaccine, and we were worried, what if they went out of business or they had a problem with production? How are we going to ensure that these vaccines were available? Their concern was, as expressed to us, they were very concerned about the liability issues that they confronted.

Now, I can debate with you whether how real those liability issues were, but that certainly was how they perceived it. And as a result, manufacturers were going out of the business of doing research and developing life-saving vaccines. And so we created this program to take away, to a great extent, the liability issue and provide a greater incentive for manufacturers to stay in the business and to go in the business. And the truth is, from that perspective, I think that program has been enormously successful.

Harlan Krumholz: One quick follow-up. I’ve heard from people that with regard to the COVID vaccine, they’re not qualifying for this program. And when you did this program, how did you decide what the qualification terms would be? Because obviously, many people might come forward, and can you just explain a little bit about the strategy you took?

Ruth Katz: Sure. At the time that we enacted the legislation, the emphasis, the primary emphasis was on childhood vaccines, and we created a table of injuries that we worked with experts to develop. That table was developed based on the vaccines that were then available and used regularly and recommended by the Centers for Disease Control and Prevention as routine vaccines. So you had the DPT vaccine, the diptheria-pertussis-tetanus vaccine; MMR for measles, mumps, rubella; the polio vaccine. There was no COVID vaccine. There wasn’t the vast majority of vaccines that are now available.

In order to update that table of injuries, which is what we have to do to be able to cover some of the injuries that may have occurred through COVID, the Secretary of HHS has the authority to update it or it can be updated through legislation. And I understand, I haven’t followed it as closely as I once did, there have been some updates that have been put together by various Secretaries of Health and Human Services, but there’s been no major legislation along these lines. And so until the COVID vaccine and many of the others that are now done routinely are included, they’re not covered by this law.

The bottom line is we worked on this when the only vaccines, frankly, people we’re dealing with were childhood vaccines and that’s mostly covered in the bill.

Harlan Krumholz: But you built in the ability to update it and that just is what needs to happen.

Ruth Katz: Yes, exactly.

Harlan Krumholz: Yeah, that’s great.

Howard Forman: I want to address your current work because you’ve been doing that for a while right now, and I think a lot of our listeners probably don’t know what the Aspen Institute does and how important it is both for career development, professional development, for development of information communications and so on.

And I want to just point out that during 2020, you and I had a conversation about what would happen when the vaccine came out presumably in 2021, like what were we going to do about misinformation and disinformation? And you pointed out that Aspen had come out with a major report, I think a year earlier around 2019, or maybe it was early 2020. First of all, just tell us a little about Aspen Institute, but what is the process by which you develop reports to inform the public about important topics?

Ruth Katz: Sure. First, let me just briefly describe the Aspen Institute and who we are. The Aspen Institute is actually a global nonprofit organization committed to realizing a free, just, and equitable society. The institute has actually been around since 1949. We’re celebrating our 75th anniversary this year, and we try to achieve that goal by driving change through dialogue, which you’ve mentioned, leadership, and action to try and solve some of the most pressing, most important challenges facing the United States, and indeed, the world.

We have taken up the issue of the opioid epidemic, antibiotic resistance, health data privacy, incarceration and health, gun violence, end-of-life care, but we’ve also taken on some of the health financing issues that we read about all the time, healthcare costs. We’re doing a series of convenings on that topic. In fact, at the end of the month, we’re doing a big convening on what’s happening with healthcare consolidation and what it means in terms of access and affordability and quality of care.

But in all these cases, we identify co-chairs of the convenings that we put together that frankly will be a big draw on trying to bring together members who generally are not what you would normally expect. We try to think out of the box to bring different perspectives to whatever the topic will be.

To give you an example, this Aspen Health Strategy Group, co-chaired by Kathleen [Sebelius] and Bill [Frist], we took on the opioid epidemic long before everybody was talking about an opioid epidemic. One of the members of the group was the then-president of CVS. The members of this working group are leaders across the healthcare spectrum. At that time, the president and CEO of CVS was on the committee. And one of the recommendations of the group was to limit the scope and duration of filling prescriptions for opioids, and we made a recommendation on what that might be.

I don’t think we can take full credit for it, but the president of CVS, and CVS was the very first to put a limit of two weeks and a certain number of pills that the pharmacies, CVS pharmacies, would actually fill at any given time. And he could do that because he was president of CVS. And many of the people that we try and include in the work that we do come from organizations, not necessarily associations because associations themselves have to reach consensus, but they’re in a position, because they’re leaders, to go back and actually take action and do something to address the problem.

Howard Forman: Can you comment on... you worked in Congress a lot, and one of the things that I’ve observed is that a lot of the people that work in Congress, particularly on the Democratic side, they don’t turn over that quickly, so I’m fairly confident that you’re still in touch with enough people that work in the House and the Senate.

It seems to me that even though we hear about tremendous partisanship, and that I’m sure that’s true overall within the House and the Senate, it seems to me that we’ve actually seen considerable healthcare legislation pass, including the Inflation Reduction Act, provisions for prescription drugs, and other legislation related to Medicare and Medicaid and the NIH and all those things. I’m wondering what your sense is about how Congress functions regarding healthcare with or without regard to the rest of Congress and how it functions.

Ruth Katz: I will say back in the ’80s and ’90s, I think there was much more, much more collaboration and cooperation between Democrats and Republicans and certainly among staff in working particularly in health legislation. When I was up there, we passed boatloads of legislation that had bipartisan support.

I will tell you, in the case of the Affordable Care Act, where I returned, I had left the Hill for a while, I was back specifically to work on the Affordable Care Act for four years, we never, never met with our colleagues on the Republican side because they made it clear from Day One that no Republican was going to vote for the Affordable Care Act or any version of it. And indeed, we had to find 218 Democrat votes to get that bill passed all the way through. Medicare and Medicaid, there was a lot of cooperation. Unfortunately, I think even in healthcare that, less so than certainly there was in the old days, and it is really, really a struggle.

Howard Forman: Thank you very much. I mean, I can’t tell you how honored we are to have you on the podcast and just to have you as a friend and just grateful for everything that you’ve done.

Harlan Krumholz: Yeah, thanks so much, Ruth.

Ruth Katz: Well, thank you so much for the opportunity.

Harlan Krumholz: Hey, that was an amazing interview.

Howard Forman: Amazing.

Harlan Krumholz: Love Ruth. But Howie, even with everything else, I always look forward to this part of the program. Tell me what’s on your mind this week.

Howard Forman: Yeah. So you and I talked about the risks of medical tourism almost a year ago with regard to Mexico and cosmetic surgery, and now we have a different example of medical tourism with potentially substantial risk.

So three separate patients went to three separate clinics in Mexico for treatment of three different conditions with one thing in common: they all received stem cell injections. One patient had multiple sclerosis, and for them, the treatment was intrathecal, meaning into the spinal column, injection of the stem cells; one person had psoriatic arthritis of the elbow, and the injection was made into the elbow; and one person had bilateral knee osteoarthritis, and the injection was into both knees.

In all cases, embryonic stem cells were used. These are the stem cells that are typically donated from umbilical cord blood. The provenance of these cells is unknown, so I don’t know if they were packaged together. The investigators don’t know. The CDC doesn’t know. But given that they all gave rise to the same infection, they were likely somehow prepared in the same batch. Each patient developed infection with a rare form of drug-resistant mycobacterium, the same genus as the bacterium that causes tuberculosis. In one patient, unsurprisingly, the infection manifested as meningitis. In the other two, joint infections.

So quick take-home messages. One, medical tourism is in fact risky, and risky in ways that are beyond our usual risk-taking. You have underregulated providers using underregulated materials in a setting where recourse is minimal when things go wrong. I understand the impulse for looking for cheaper options or options that might not be available in the U.S., but I don’t believe most people understand these risks. And two, stem cell treatments for each of these indications are equivocal at best in terms of effectiveness. And going back to what you talked about in the opening segment, there are a substantial number of articles that talk about effectiveness and substantial numbers that talk about lack of effectiveness or even harm for each of them. There’s ongoing research, including randomized controlled trials as well, but there is just no hard evidence of significant positive effect, and I found papers that come to the opposite conclusions as well.

I imagine most of our listeners are cautious about such matters, but I just want to remind everybody, in these underregulated and unregulated areas of healthcare, caveat emptor.

Harlan Krumholz: Well, Howie, this is such a deep topic. Let me just pick off the stem cell thing first. I just don’t get it. I remember on one of the episodes, I talked about how when my father went in for knee replacement and the orthopedic surgeon offered him stem cells for five thousand bucks.

Howard Forman: Generously, yeah. Right.

Harlan Krumholz: Yeah. In my own town, I see ads in the local newspaper for someone who’s offering these. I just don’t get the stem cells. Caveat emptor, absolutely. With regard to cross-the-border stuff, you’ve got to be careful. But I have heard good stories too where people have gone to centers of excellence for hip replacements, for example, at a fraction of a cost, people who might not have been able to afford it or who have found that these can be a savior for them in terms of—

Howard Forman: Absolutely. And I don’t mean to diminish, either in Mexico or anywhere else, that there aren’t really good providers. What I do point out though is in this case, again, the CDC is—even working with Mexican public health authorities, they’re unable to get good answers from these clinics or even reach them. This is different.

Harlan Krumholz: A hundred percent. And you’re talking about these clinics that are really using questionable approaches that really have no evidence. And I’m also just raising that some of the reasons people are going to these places for other types of treatments is because of problems in our healthcare system—

Howard Forman: That’s right.

Harlan Krumholz: ... with access and affordability. So yeah, we have to figure out how to keep the good part of this. Meanwhile, we need to fix our own system. But these people to be warned about these things. The infection is a horrible complication.

Howard Forman: Scary.

Harlan Krumholz: Yeah. 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 or to keep the conversation going, email us at health.veritas@yale.edu, or follow us on LinkedIn, Threads, Twitter, or wherever you may find us on social media.

Harlan Krumholz: And we’re eager for your feedback, questions, your own experiences with these topics. And if you like the podcast or you don’t like it, you got strong feelings about it, rate us and review us on your favorite app. We always read the reviews and it helps listeners find us.

Howard Forman: 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 the website at som.yale.edu/emba.

And again, reminding you that in just two weeks, we’re going to do a live podcast at the Yale Innovation Summit on May 30th. The link’s in the show notes today. Come to the Innovation Summit, there are going to be nearly a thousand people attending, and see us interview some of the greatest health and technology innovators.

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, extraordinary people who every week help us so much and make us sound good, as good as they can.

Howard Forman: Very thankful to them.

Harlan Krumholz: Yeah. Talk to you soon, Howie.

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