Regulation, consternation, Food and Drug Administration - with Robert Califf

This episode is brought to you by the partnership for quality measurement, powered by Battelle. Discover how quality measurement is transforming healthcare and how you can help at p4qm.org. That's p the number 4, qm.org. Hello and welcome to Turn on the Lights. I'm Jay Armate. And I'm Don Burwick. With Turn on the Lights, we put a spotlight on ways to improve the healthcare system in the US. Thanks for listening. Occasionally on the program, Don, we have the opportunity to talk with one of our heroes, one of the great civil servants of our time. Today on the program, we have an opportunity to do just that. We're going to talk to a former head of the Food and Drug Administration, Dr. Robert K. Liff, you're going to introduce him in a moment. We're going to talk a little bit about FDA and what FDA means to the healthcare ecosystem. But we're also going to talk very importantly about the concept of evidence-informed policy. When does science and how does science matter? How does it help us create policies that will keep us safe and keep us healthier into the future? And what's at stake at the present moment as things change in Washington and in the federal landscape and at the FDA? Our guest is Dr. Rob K. Liff. Rob is a distinguished American cardiologist and did some crucial work behind the enormous progress we've made against heart disease in our country. He has twice served as the head of the FDA, both under the Obama Administration and then under the Biden administration. The Food and Drug Administration is a mainstay of excellence and assurance to the American public about the foods, drugs, and products that we consume. And he's here to tell us about how that works and a little bit of commentary on the current situation at the FDA. Dr. Rob K. Liff, welcome to Turn on the Lights. Glad I can join. So let's start with you a little bit. We're certainly going to talk about the Food and Drug Administration as the main theme, but tell us a little bit about yourself. Well, as I like to say, I'm just a country boy from South Carolina, born in Anderson. My dad was teaching at Clemson University as an architect and then he decided quit teaching and practice and we moved down to Columbia where I grew up and then avid basketball player and sportsman and then migrated north to Duke University as a freshman in 1969 and pretty much other than a few years in San Francisco and how staff have served just about every role it do. In fact, it's now the centennial year of the university and I've been associated with it for more than half of its existence. I don't know what that means. And then you know, my work career has been as a cardiologist and I'd say greatest expenditure of time has been intensive care units and outpatient clinics and patient care, but that led to a deep interest in trying to figure out out of all the options we had which ones worked and which ones didn't. And because in the 1970s, as audits, this may sound today, I'd access to computing that almost no other place in medicine had. His Duke was a leader in the technology. Yeah, you remember Don, I think re-onxers is hard to imagine when all records were handwritten by doctors and nurses and we were among the first to develop a computerized database as we call it in the 1960s and 70s Eugene Stead was actually a direct mentor of mine, sort of the mastermind of that. And so we became a coordinating center for clinical trials. And I think the thing that spoiled me that I've still not gotten over was that we were doing research directly on the patients that we were seeing in practice. So it was not two separate things. There was the practice of medicine and there was running into time after time when you didn't know what to do. And you could actually do observational and randomized research pretty much in real time. Somehow I got the view that every part of medicine should do that, but here we are 50 years later and we're not there. Rob, all the things you could have done, why did you choose medicine? Yes, a funny story. I was going to be a clinical psychologist. I was, you remember, I enrolled in 1969 and undergrad. That was the peak of the Vietnam War. We didn't have many classes that year, actually, most of the time classes were out. But I was doing really well in studying all kind of interesting esoteric things. And then I worked in the state prison system in South Carolina for two summers. Interestingly, I was a member of the Pore State Championship basketball team and put together a prison basketball team went around playing other entities. Most of them were players I'd played against in high school and now I've taken a different turn. But I learned I was picked pocketed, actually, on one of those adventures by one of my friends. And through it all, I just sort of felt like I should do something for me that would have a more tangible outcome. And of course, cardiology is about as tangible as it gets. Maybe orthopedic surgery would be more tangible, but I saw a patient defibrillated as I was going along the way. And what could be better than someone who's dead in one minute and a little bit of electricity and their back alive. So that was really what turned it was wanting to do something with a tangible effect. And so from there, you went, you clinical practice for some time. You had other turns in your career, but you ended up at FDA for a period of time. Can you tell us about the food and drug administration, how you came to be there, and a little bit about what the role of the FDA is in the healthcare landscape? Sure. Because, you know, it's my first year as a fellow, the head of the coronary care unit, I decided to go into private practice. So I got a call out of the blue saying, how would you like to be the CCU attending at the same time you're finishing your fellowship? And you get to princely sum up 35,000 bucks a year to be on call 12 out of 14 nights and two hospitals. But that was a year that the first angiogram was done showing that it indeed was a blood clot that was causing heart attacks, the leading cause of death, really in the world at that time. And still a very important cause of death. So the race was on to figure out what to do. We knew what the target was. And so we got involved in, as I mentioned before, coordinating clinical trials. It actually started with a group of us who had been interns together at UCSF. Also a little bit odd. I mean, that was also the time when we were inundated with AIDS patients, but we didn't know what it was. You would have thought we'd all gone into infectious disease, but a group of us went into cardiology, eric toe, bold, dean, karyakas, and others. We would literally do a case and then congregate and look at films in some central location and try to figure out what to do next. That evolved into coordinating larger and larger clinical trials. And before we knew it, we were coordinating trials of 10 to 40,000 patients. And of course, that led to interactions with the FDA. And I found the FDA to be the pinnacle in my view of the evaluation of risks and benefits of treatment. There was so much knowledge and the interactions we had were fascinating. And in fact, I was interviewed twice for FDA commissioner along the way and rejected because of the abortion question. These were doing Republican administrations. Didn't take many questions to weed me out as a candidate. And wasn't really thinking about it when Peggy Hamburg flew down the Durham to tell me that she was going to retire after six years, which is a long stint in that job. It's a tough job as Donna's, but she couldn't appoint me as an ex commissioner. President has to do that. And at that time in my career, I felt like I'd sort of done what I could do in academia. I had not served in the Vietnam War. Many of my friends did not making an argument that that would have been the right order to serve in, but just federal servicing like the right thing to do. So I spent a year as a civil servant. And then the president Obama asked me to be commissioner and it happened after that. But I won't tell you that one year as a civil servant was revolutionary in my thinking. Well, was it, I tell us more about that year? Was it that that helped shake you? I felt like I was really privileged because I came in. Of course, I took a big hit in pay, which was okay at that point in my life. It didn't really matter. But I was definitely commissioner for medical products in tobacco, which was a job that I would say most people running parts of the FDA didn't want filled because, sensibly, they'd be reporting to me. But what happened was because of my history of knowing many of these people, they were extraordinarily nice to me. But I didn't really have to perform the functions of leadership like I had before of line in line command or accountability for a lot of people. So I had to run of the whole FDA essentially to learn about how it worked and to dive into topics that I thought were important. And I just learned all kinds of things that didn't know anything about before and also developed a very deep respect for people who go into civil service. I mean, it's a refreshing thing when the welfare of the American people is your mission as opposed to making money for whatever entity you're working for. Well, I kind of were reflecting on our parallel experiences. I also was, as you know, called the Washington Run Medicare and Medicaid by President Obama and it was a very major transition for me from the private sector to public service. This is sort of a pop quiz. But so when I was going there, people said, oh, you'll get eaten alive by the bureaucracy, the bureaucracy, the bureaucracy will eat you. What was your experience with that? I would say, I would call it mixed. I think it's a terrible thing, the way people at position civil servants says bureaucrats, you know, with distainfully said, that's completely wrong. These are people who are highly motivated and work hard. I would say though that the rules and regulations around personnel management in particular, I think have been detrimental to the functioning of the civil service. And we can talk about it more, but I think the patterns of interaction that developed over the years between Congress, the executive branch, and the agencies were very problematic. It just made it really hard to do simple things. And so what I mean by mixes for the people, my esteemed grew by leaps and bounds the more time I spent. For the system, I saw a lot of things that I thought need to be fixed. And you know, I also don't, I'd be interested in your view on this. I'm not interviewing you. But over time, particularly the second time around, I felt like FDA function probably better than most of the other federal agencies because it's sort of at the interface of the ground in the federal bureaucracy. Things happen at the FDA that are very tangible. And the group actually felt the worse for where the people at CMS because these were really smart people who knew what needed to be done, but they couldn't do it because to do the things that really made the biggest difference. And actually what I helped the FDA the most in my opinion, were bounded by law. And this is, I get back to that interaction with Congress. Things were just locked into approaches that you couldn't change without Congress passing a law. And we all know that Congress not very good at passing laws here last 20 years. Yeah. I mean, developed infinite respect for the expertise and the devotion of so many of the staff at CMS. And they really knew stuff that I didn't know stuff I could never learn actually because it was extremely complicated. We were both you and I stuck in a time when it's still there of a kind of gridlock with Congress. You know, what I learned was to work below the level of Congress with regulation and some regulatory activity, but no, it was I shared your registration, but also you're actually joy in working with this workforce. But you know, Katar asked you at the beginning question above you to say a bit more about which is, so what does the FDA do? What is it? And in particular, when you got there, what was your vision of stuff you'd like to do differently? Well, remember I was there twice. So the first time around, you know, I really came in and took notes as a civil servant, but also knew one of the things I took notes on is I was then commissioner in the last year of the Obama tenure. And there are a lot of things that the administration wanted to get done. And my main job was to help get those things done as best I could. I couldn't make major systemic changes, but I had a list that I wanted to do thinking that the election would go differently. What was on the list? Well, there was a lot of work that needed to be done on both the food and tobacco parts of the FDA. When the public thinks about FDA, until recently, they've just thought about drugs and devices, mostly drugs, particularly the policy people. But the F and FDA does stand for food. It's almost half of what the FDA does. And tobacco is still at least in the top three, if not the top, remedial, bulk, cause of death in the US. And there were just many issues that needed to get worked out on the food side. A lot of it just had to do with funding. As you know, years ago, user fees were implemented on the medical product side. And while I'm congenitally opposed to user fees as a way to fund the FDA, it turned out that that was the only way to get funds for the FDA. So the medical product side was well funded. However, for user fees, the people getting regulated provide the money to regulate them. Is that what that's right? So what happened on the food side where you don't have user fees is that for 25 years, the food side has been absolutely flat adjusting for inflation when food as a commodity has become more and more complex and global supply chain mediated tobacco was different because there it's a totally different type of regulation. Every other part of the FDA, the premise that you start with the premise that the industries that are making products are intending to improve people's health. That's their goal. And they lose their way and it's hard and all that. So you need regulation to teach that on a control on the tobacco side you're dealing with an industry which is killing people. And the goal is to reduce death and disability to the maximum extent that you can within the law. And so there were just many things about the tobacco side that needed work on the medical product side. The thing I wanted to do the most really got sort of sidetracked because I came back the second time in the middle of the Omicron wave and the pandemic really dominated in terms of what needed to be done at the start. Well, was it that you were hoping to do with that part of the devices and so on? Yeah. Good. Well, this is where I think more thinking what people like Don would still be helpful because there may be an opening now to move this along. But I'll start with just a story that my history was doing large pragmatic clinical trials in cardiovascular metabolic medicine where you would and randomized thousands of people get a definitive answer. Things that didn't work by and large didn't get on the market or weren't used and things that did work got into clinical practice guidelines and eventually became quality measures and got widely used. And to me, it's always more complicated than this. But the simple story is death rates from heart attack and acute coronary syndromes and heart failure have plummeted because we've developed effective therapies and they got used imperfectly, but they did. But the law says to get a product on the market, all you need to do is demonstrate without equating well-controlled clinical studies that benefits our way risk for some population for some period of time in a particular context of use. Nothing else is actually required by law. And so in most areas of medicine, you don't do large clinical trials and in fact, there's been a goal to do trials as small as possible. And so we end up tossing huge numbers of products out on the market who if they were used exactly the way the clinical trials were done were probably be just fine. But there is no requirement that anyone does comparative effectiveness, how long to give it, what the right dose actually is, how to combine it with other therapies and many of the issues and the heterogeneity of treatment effect that are very important in populations. And we have no system in the US to make that happen. And so it becomes a battle of marketeers and lawyers to deal with the market. So Rob, let me make sure, and just now we say, under law, the FDA approves a drug for a particular population in which the evidence is about efficacy and safety for a particular population in a particular disease category. But once it's on the market, it can be used more widely than that evidence supports. Oh yeah, that's called the practice of medicine. And this has been tested in court during my time because you may remember the most successful public campaign in the history of the FDA as far as well. Recent history was the famous tweed. Don't be a horse, don't be a cow, don't use ovure mectin driven by the fact that we had many rural people who were taking animal doses of ovure mectin mistakenly with harm being done. The thing was viral, but we were then taken to court and the court order said, you can't use a motive, messages and FDA is not a doctor. And so there's a lot of legal precedent for off-label use, but that was sort of a poignant example of it. So take us into the machinery here for just a second. I mean, most of our audience may not know the ins and outs of how medications, devices, food, tobacco are understood and on FDA. What's the process to look like to get a medication or food through regulatory approvals and hurdles? And a sense of how long it takes, how many things does FDA look at on an annual basis? What's the geometry, the scale of what FDA is looking at right now? Well, a couple of just background facts. FDA regulates between 20 and 25% of the economy and it regulates the products, not the people, not the practitioners in the sense of medical practice, as you know, medical practice and nursing et cetera, regulated by state boards, et cetera. The second is, I think the best way to think about the everyday life of the FDA is it's a referee. That is, the FDA doesn't write the laws. In essence, if you thought of this like a sport, it's the end. which is US Congress that writes the laws. The laws can be interpreted to some extent. And this gets back to what Don and I were talking about with federal agencies. Recent court decisions have really restricted the leeway of interpretation of the laws. And I'm a basketball player by history. So many people on the audience, approximately, may were the block charge issue. - Okay. - When is it a block and when is the charge? - And there's a rule book that the referees go by, but every year they do a little bit of a nuanced interpretation and let it be known. And so that's the way to think about the FDA. There's a rule book. And the rules, there is an encompassing law called the Food Drug and Cosmetic Act that has many, many sections. But for each of these commodities, the rules are different because the circumstances are different. Because of the catastrophes of the letamine where large numbers of children were born with birth defects in the US and the Dalcon shield where a number of women got infected with a device that was inserted. For drugs and devices, pre-market evaluation is required by law. And this is where benefits outweigh risks, formative and well-controlled clinical studies and the view of experts in the field. That's sort of the way to think about it. Forks, food, basically food was here well before the FDA. And people decided you can't do a pre-market evaluation of food. It's really a post-market system with some exceptions where the FDA deals with food safety for the most part and helps by writing labels that might reflect nutritional knowledge. And we can talk more about that. For tobacco, it's a new law. People forget that a lot of us, people like, not and I remember David Kester is heroically taking on the tobacco industry when he was FDA commissioner as a very young person. But he actually lost. And he lost in the Supreme Court after getting Congress to go along with it. But they ruled that nicotine was not a drug. And it was only when Obama was elected that the FDA was given the authority to regulate tobacco with the Tobacco Control Act. But as I say, that's an entirely different circumstance. You had a number of products already on the market, obviously. The law says you can't reduce nicotine to zero, which, if you did that, it would do away with tobacco because it's the addiction that keeps people tying back. And vaping came on the scene. So vaping products, they require a pre-market authorization, but no one anticipated it. It was during my time that we put through the regulation that said vaping will be regulated as part of tobacco. But we had no idea there would be 27 million vaping products that had to be adjudicated. So each one is different. But let's just talk about drugs for a minute, because I think there's some real lessons here. For drugs, let's say you're a scientist in the lab, and you figure out this new biological target, a pathway that might treat a disease like diabetes or multiple myeloma. You have to do a whole lot of work in pre-clinical research to get to the point where you can convince an investor, which might be a pharmaceutical company, it might be a venture capitalist, convinced investors to put money in to do human clinical trials. But you also have to convince not only the investors and the company that would manufacture it, but also the clinical researchers, the human beings who do the studies and the FDA and the institutional review board that you've reached the point where it's OK to do a human study where it's ethical. It turns out if you take 100,000 of these inventions, mostly done in academia, only about 1,000 are going to make it into that early phase. And then you have to do the studies to show that the benefits outweigh the risks for just one indication. Sounds easy, right? Out of all the things, you just got to hit it right one time. Out of every 100 that get into phase one clinical trials, only 10 make it to market. Because as smart as we think we are, our mother nature is still smarter than we are. And I think a very important point is that over the last 40 years, and I've had the privilege of being on all sides of this and take some little bit of credit for helping to make it happen, people focus on the dramatic cases where a company puts in an application for marketing, and there's an advisory committee meeting, and there's a public spectacle and decision gets made that people argue about. 95% of the work of the FDA is in the 10 years before that, where most things have started out, never get to the point of an application, because they're found either to be ineffective or to have toxicity, or you can't make it. People also don't think much about the manufacturing. So all these dynamics, when people say 10 years to get a drug approved, well, that's not quite right. Almost every drug that's been a blockbuster started out for one thing and ended up being good for something else. And you learned that along the way, doing the human clinical trials, and they take time. So that's sort of the story there. Well, yes. Towards the tail end of this process, there is this group of experts are gathered. There's a bit of decision making around whether a drug should get approval. There's been some famous cases recently, Agile Helm, one of the Alzheimer's drugs being one of them, where there is a mixture. You're describing a very, I think, rigorous scientific process that I think we can all appreciate is necessary to determine whether a medication should be used and should be used for a particular indication. There's also been some kind of concern that there's disease advocates, people that are passionate about a particular medication or particular issue related to a condition that might be interfering with that scientific process. Could you help us understand what might be happening in those committees and what might be taking place that might cause challenges there? First of all, just to remind you, their disease advocates all the way along the way. And we need disease advocates. They're very important to push things and make things happen. And so most of the actions already happen. You're left with these few things. And then we have advisory committees. And the keyword there is advisory. Advisory committees do not make decisions. They give advice. Mm-hmm. And so just a question of what advisory committee should be doing with something that I made some relatively unpopular statements about, but I still actually believe I'm right. And let me just add, one of the greatest things in my career is being chair of the Cardiorenal Advisory Committee at the FDA. It's where all the knowledge about this product comes together. But the vast majority of things that get to that point of decision making don't go to an advisory committee 'cause there's no question. There's no argument. So you get sort of a very skewed view when you look at the few cases out of these thousand things that got started in human clinical trials. The few cases that get to advisory committee 'cause they're chosen because the FDA has questions. It's a civil servants well until this year. It's a civil servants at the FDA who make the decisions. One of the main jobs of the commissioner in my view is to protect the civil servants from the political process because you're focused on the push from disease advocates who may have a point of view. They're also the naysayers. And I refer you to a New York Times article coming out this weekend that points out there are people who have never been in favor of anything to be approved by the FDA and make their living criticizing the FDA. And they have their point of view. They have every right to do that. I'm not opposed to them. And then you got politicians. You know, I'd say most of the calls I got from politicians during my both tenures were after lobbyists had been advocating one thing or another on all sides of it. So one of the fun things about being FDA commissioner is everybody seems to have an opinion about what you should or shouldn't be doing. But the beauty of it in my view, as flawed as it is, is that the people making those decisions are full time civil servants who are not allowed to have financial conflicts of interest and who are pretty rigorously watched. In a transparent system that by law, their documents and differences of opinion are actually available for public discussion. So I agree with you that there is a real beauty to that protection of the subject matter experts that are within the agencies. At least I understand them. Okay, so you probably know more about the FDA than anybody alive having served twice as the head in your comment just now you said until now. So let's step out onto that, hopefully not too thin ice. What's going on right now with the FDA and what do you think about it? Well, my views are pretty publicly known and I want to talk about my success or just out of adherence to protocol, I think. All living former FDA commissioners and deputy commissioners talk with each other frequently and generally form a support group to try to help FDA succeed. But I will talk about what HHS has done and I have no respect, I guess I'll say for the RFK junior and what went on before my successor was appointed which was devastating, summarily firing thousands of people for no cause other than reducing size using what was called AI. But I don't know about you, but if my AI in the places I've worked was as bad as that AI, I would have been fired [BLANK_AUDIO] trying to employ it. I mean, it was pathetic. And most of the leaders were also shown the door. And now what's happened is you have the HHS leader making his own decisions with no transparency as to the underlying data or reasons for that and overruling every part of the FDA. And you have people quitting like Peter Marx from biologics and also over at NIH, Kevin Hall, and I think their letters really tell the whole story. What we have going on now is a situation pardon me for these phrases, but Donna and I know you and I have been advocates of evidence-based policy. What we have now is policy-based evidence, which is what trial lawyers actually do. And it's the right thing for trial lawyers to do if you are defending a client as a lawyer, your job is to advocate for your client. And what's happening now is our arcade is that's what the answer is and then dispatch as experts to go get the evidence to support the answer. And that is extraordinarily dangerous in my view. Dangerous how? What are the potential implications for people listening to this show? You know, just ordinary citizens and maybe people with diseases? Well, the beauty of evidence-based policy is while we all have biases, you go into it with a transparent public process of airing the data, having arguments about it, and then eventually you make a decision. And often there'll be, you know, some decisions are you're 100% sure, and most of them you might be 90% sure. So I'm you're 55% sure. And in that case, there'll be a whole other group of people who are just as sure on the other side. But it's a public process based on the data. If we look at what just happened with the recommendation of maternal COVID vaccination, the presentation from the CDC was not even allowed to be presented. And so you had, I'm sorry, on the Thamara Salad decision. I'm sorry. Some other thing on the COVID maternal decision. So you're not having a public airing of the, and as you know, Don, there's a thing called the administrative record, which is where at any time in the future, the internal deliberations are publicly available, including the descent. But these decisions are being made without from anything I can see a public record that actually reflects the underlying data and findings. And I think that's extraordinary dangerous and can lead to very bad decisions. And it's sort of a rebellion because it's being called radical transparency, but it's the opposite. So very hard for me to ban them. What's the material impact of this? On the people that are listening to this program, on all of us really, we all consume, yeah, you said earlier in this program, 20 to 25% of the stuff in our economy, food, medicines, devices, increasingly AI even, we consume a ton of the stuff that FDA helps to keep safe for us. What's the material consequence of this lack of transparency that you're describing? Like making real for us, what's going to potentially be different about the food we, the medicines we consume? What do you worry about most? First of all, let me just say that right now, the majority, I've described all these things that happen behind the scenes at the FDA that you don't ever hear about. And those are still going on. They're impaired somewhat because so many people have been fired that the workforce is depleted. And there's several good news articles about that, just this week that I think speak for themselves. Then there's some big decisions that are very transparent. We can be concrete about maternal COVID vaccination is a good example. Pregnant women are very high risks for COVID complications. Decisions were made without a real airing of the data in public discussion. Women and children could be harmed by this. Well, no, we have more measles cases than ever in the history, the recent history of the United States when we thought we had eradicated it so much so that just, you know, I'm back at Duke University now, we had to have a grand round zone measles because the doctors haven't seen measles cases. Now we have one in North Carolina with more to come. And yet we have lack of advocacy for vaccination as a policy. So there are many, many things like that could be employed underneath it all and this makes it hard. It might be easy to be hyperbolic and over dramatic. And so I think it's better to think like I like the pod hole analogy. If you're running the city and you decide I'm not going to fix the pod holes for six months and I'm not going to really pay attention to it. And I'm going to just do what I think is right. Nothing terrible will happen for a while. And then some bad things really start to happen. So I think a lot of us are on edge right now about this. So what should we do about it? I mean, so you kind of name the problem here and you're concerned about it. Those of us listening, we can see the pod holes forming if you will. And yeah, I feel like there's a bit of uncertainty as to what we could do about it. If you had your way at the moment, what would you ask our audience to do to start helping to address these first? I'll let me go back to one thing I didn't mention about all this. Again, just emphasize, I think the beauty of the system the way it's been is that civil servants are making these decisions. It's like referees. They're making decisions based on a rulebook and you may disagree with them. They may make a bad call hard to think of a better system. Once you begin to have politicians interfering with those decisions and making those decisions, it has huge applications for all sorts of other things like if it takes 10 years to develop a drug, you don't know what the next commission and the next HHS secretary might believe whereas the whole system now is based on a reliable progression of thinking to an endpoint that can be adjudicated by a set of rules. So what can people do? I think particularly, I mean, this is really hard for the general public to deal with. So I'm just going to say the general public in general ought to be very concerned about corruption in government, which where politicians will do favors for their friends in ways that can move large amounts of money. And I'm not saying that's happening for that reason, but it's the rest that's being taken. I think the people that need to be active right now are the academicians, the industries that are regulated because they need a set of rules that they can depend on in order to be successful in what they do. And they need to be loud and speak to the current commissioner and the head of NIH and to Congress because frankly, Congress right now is, you know, it's easy to say not doing its job, it's not doing its job, but that's probably for reasons that are complicated and it would be good if there was a little more courage on the congressional side. Rob, you've been quoted. It don't let me misquote you here as saying that the FDA, as we have known it, is gone. I don't know exactly what you said, what words you chose. But I guess my question is, is this repairable? That is, are we in a downward spiral respect to the independence of the expertise that's housed within FDA, not to mention other agencies that we can't recover from? Or what's your-- We're in America. Yeah, I'm not a historian, but my view of American history. And remember, I grew up in South Carolina and sort of living with the history. We've been on the precipice a number of times and come back from it. I think all of this is repairable. And let me hasten to add, we talked earlier about how frustrating some of the things were the way it works in Washington. So I've been widely advocating Humpty-Dompty as a correct analogy here. A lot of people corrected right after the election. I had read Project 2025. I grew up with South Carolina politicians. I felt like I knew what was likely to happen. So I floated Humpty-Dompty and I got this avalanche of, well, you can't tell people we can't put Humpty-Dompty back together again. Well, that's the first verse. It turns out in the modern version of Humpty-Dompty. There's a fifth verse where Humpty-Dompty is put back together again. And I actually think there was enough corrections needed in the system the way it worked that if we don't go too far, I think Humpty-Dompty is only like halfway down right now, but to the floor. But if we don't go too far, we can put it back together, taking into account the things that didn't work and fix it. Despite the exodus of a lot of talent from federal agencies, you think in the end we would recruit the talent back or how you think about the repair of Humpty-Dompty at that level? Yeah. I mean, all this depends on elections and leadership, but I mean, I'm communicating every day with people who I've left or are sticking it out at the FDA. And there's a reservoir of deep commitment to public health. You know that from the people that you worked with. And I think people would rush back and if they had a chance to create something that got rid of the things that everybody hated and kept the things that were good, we could end up with something better. Also, just to say it, the current leadership could turn things around. I noticed there are actually hiring people back at FDA now. You might ask the question why on earth would you tell people their faces, their sock puppets of industry, which is what happened with RFK, and then fire thousands of them if you're going to hire them back. Maybe you should have done your homework to start with, but that is happening. And so I think the pressure of, I mean, you know this well done. If things really stop working, the industries that are regulated and the people who are dependent on those industries can get pretty aggressive. But yeah, there's a real risk I think in those other, you know, the system that we have it in have understood for so long, fallen apart. It makes it very risky for those industries to do business. I'm sure. Well, I have, we're coming closer to the end of our time here, unfortunately, but I do have one last question for you, which is FDA is, you know, you said so much of what we use and eat and consume every day. There is a new technology, artificial intelligence technologies that are dawning kind of at the earliest stages of wide scale adoption in healthcare now. Do you see a role here for FDA in helping to regulate and make those technologies safe for human application in the future? What's your sense of AI regulation and FDA? Well, I think we wrote a lot about this during the last quarter that I was in FDA because you could see it coming and the technology is changing so fast. I also felt privileged because between my two FDA stands, I spent five years at alphabet in many of the people that really have developed this technology were there and there's such an interchange between alphabet and Microsoft and open AI's that evolved in terms of leadership and talent. I'm not a computer scientist, so I'm not talking technically here, but in brief, the FDA has a major role in the regulation of software as a medical device and it also has a major role in terms of helping the industries use AI and product development. There's a major role internally at FDA. If we think about clinicians and a clinic, we all know that ambient scribes are taking off. It should be great and Donna, think about you every time with your journal article in JAMA about greed, about the question there is, are you going to allow clinicians to actually talk and work with patients as opposed to just telling them to see two or three times as many patients. We'll see how that works out, but on the FDA side, think about an FDA reviewer or a product team. They spend a huge amount of time right now just reconciling documents because every decision by the FDA is subject to lawsuit. If it disadvantages, someone or a mistake is made. We've had whole things thrown out like we're the only country. Ty and come country now without graphic warnings on cigarette packages because the Supreme Court ruled that the administrative findings were not adequate or flawed in some way and that set it back five to six years. So that's a great use for AI there. The big playground here, which I think is going to be where this, I'll just say a continuum of risk is decision support. And what exactly the role of FDA is right now, it's within FDA's jurisdiction as long as it's dealing with a disease to regulate decision support. FDA has put out policies saying unless it's like software in a defibrillator or something like that, there's going to be a lot of enforcement discretion to let the field evolve. But I think ultimately there will be some tragedies. People will call for regulation. It will happen. But I'm involved right now in the number of groups working with AI. And I just say none of us know exactly what to do right now. And we just need to really immerse ourselves in it. And the last thing I'll say is I really think of AI. I just imagine myself looming my daily life now talking to you. There's a scribe in the background. I don't know if you're using it, but everyone else I talk with is that I'm going to go drive to the golf course this afternoon. And it's going to tell me exactly where to turn using AI. And I don't even think about it. It's just part of background. So I think AI will be that way in medicine and healthcare too. The special thing is that you can injure people and you can help people a lot. And that's where the regulation is going to have to be smart wise words. Well, unfortunately, at times come to an end. We have a tradition in the podcast of asking our guests the same question. It's a question of optimism and pessimism. We're in a very difficult period right now. Lots of uncertainty overall. Are you bullish? Are you optimistic that we're going to be improving care and the condition of people, including through the FDA? Or are you saying, well, not so sure anymore? Yeah, people know me know that when I say optimistic, that means on a scale of 10 proctimism, I'm out of three. I'm just, you know, I'm attracted to problems. I'm not attracted to things that are working well. And I think the existential question is the one that you raised, done in your jam, article, because if we got that right, there's almost no limit to what we can do now. And the amazing thing about being commissioner, as you can see, all the technology and development. And it's just so far beyond expectations. But right now, if you just talk about AI, if you think of AI like any other equation, you have a set of independent factors and you have a dependent variable. What is a dependent variable in American biomedicine and healthcare right now? It's financial optimization of the sub part of the system that you're working in. A fragmented, sub optimized system where the whole is so much less than the sum of the parts. And you know, pharmacy budget is a really good example, which plays out at every level. If you could save lives and reduce cost by paying more for a drug, it's really hard for people to do that at every level. Now, I'm not saying we should be paying more for drugs on average. That's not my point. And so we've got to figure out, you know, I've got my favorite slide right now. I asked Jim and I to say, but make me a slide that shows the values of professionalism and the values of business as it relates to medicine. And it's really a nice summary that came out of that. And I would say right now, financial, if you talk to anybody practicing today, including sadly, like MGB or banner academic system, money is everything. And professionalism, people talk about it, but when it comes down to decision making, it's far too undervalued. And I think unless we raise that up, it's going to be a long time until we get where we need to be. Well, thanks Rob. We're hearing that from more than one guest. I must say, oh, it's a story. We'll continue to follow Dr. Robcala. Thank you so much for joining us. I want to make a personal comment of admiration for you. You know, we need examples of people comfortable in public service and really willing to speak the truth as well as people familiar with the clinical world and even the commercial world now that's so important in healthcare. You've been an interpreter and active voice in the direction of professionalism as you just said it. And I want to thank you for your courage and for your continuing voice. And for joining us on Dr. Analhoids. Thanks. Nice to talk to you all. Take care. Thank you so much. Really appreciate it. Well, then you've known Robcala. You know, really, kind of one of our, well, I might almost say, personal hero to both of us to a degree, but you've known him for a long time. He's given us quite a good answer. The optimism, definitely, he's gone in attraction of problems. That's totally very good. I'm summarizing that interview. But he's quite a triple threat. I mean, he's a superb clinician and clinical research. He's done really a research. He's worked on the commercial side and actually received some criticism for costing the line into the profit side of healthcare and pharmaceuticals. And then as if the commissioner, he really dug in twice. He said, that job twice, man, not unwilling to speak up. Do I agree with everything he says? No. But I admire someone that is willing to take on the job of leadership in the public sector and do as well as he's done. He's obviously studied hard how to both be studiously careful in what he has to say about the current administration and use. But yet pushing in the right ways to protect the civil service. I think that was a big message that he carried in the conversation today. And also to steward the functions of an FDA, a powerful FDA that he led to help us stay safe as a country. He's had a storied other history of being one of the foundational clinical researchers in cardiology. He started a story there. Sort of a remarkable story actually of the foundations of a field. And I think that led to this belief in evidence that carries carried forward into this translational concept of taking evidence and applying it to policy. And that sort of what he said, we have the inverse of now policy that policy is guiding the evidence not the other way around, which he clearly values a great deal. You bet. A person like that with how much expertise who goes into government brings a ton because most people in government, they know the procedures and the laws and the regulations, but they don't necessarily have a feeling for the industry, even the one that regulating so he's in this valuable voice. The other thing I have to resonate with is, I mean, nothing it really enrages me more about the current administration and a lot does. But nothing more than this constant, drumbly criticism of the people who work in government. It somehow serves this interest of the current administration to make them the problem or to criticize them or treat them disrespectfully. Nothing could be farther from the truth. The people that I got to work with at CMS and that people at FDA that Rob Nosey led, they're dedicated, dedicated professionals, not as highly paid as they could be in the private sector, but who'd go to work every day to try to accomplish what governments there to do, be really deserve thanks instead of attacks. And what they're getting right now, yes, exact opposite. I feel that as well. I do think one last thing I'll say about this interview, which I thought was interesting, is that there is a sense that there's a system here, right, that has been architected over decades of industry collaborating with government to create products that are of value that create benefit for society. And what I found interesting was that there is also something, those industries, the very industries that are being regulated by government that sometimes complain about government, in some ways are dependent on this set of systems to make sure that people have confidence in the products they're creating. And in some ways, the way that we're creating this chaos in the system at the moment, with sort of all the ticks, overwhelming evidence, and dismantling that system really creates a significant amount of enterprise risk for those businesses. Because there's no truth anymore. There's no sense of assurance that product A is better than product B when it comes to safety profiles at risk to patients and people. So I kind of wonder when industry finally gets fed up with this notion that politicians can decide what product is better than any other product. And that seems like a recipe for chaos that industry won't tolerate. Industry like predictability here. That's not predictable. And adding the constant vacillation about the regulatory framework, you're right, if we want a healthy industry helping healthcare get better, it's got to be able to rely on steadiness to government that isn't very much in trouble. And Rob was telling us, Captain, verse about that. Well, it was great to have him on the program, Don, and a lot of respect between the two of you as well, which is evident in the conversation. And I hope very much that we have future civil servants that are in both of your molds, what put it that way. Thank you, enough. You're good, thanks. Thanks so, Peter. The Turn on the Lights podcast is a production of the Institute for Healthcare Improvement, a huge thank you to Don Berwick for posting this podcast with me, Kate Armate. And thank you also to the outcomes rocket team and to the IHI support team. And of course, thanks so much to all of you, our listeners, for tuning into us. Thank you.