Thanks, Bill. It's good to come back and see you, an icon of cardiovascular medicine yourself and part of a tremendous power couple in national and international biomedicine. It is true. If I seem a bit bewildered, I am reacclimating myself to civilian life on about day 40 now, having left the federal government on January 20th. It's also true that I am currently an instructor in medicine, right where I started in 1978. It's a true story that, amazingly enough, when I agreed to unretire from Duke for the second time, they told me, 'To get your name badge, you have to go through a background check.' And I said, 'Wait a minute. I had top security clearance yesterday from the federal government, and you're telling me you got to do a background check.' So they did that, and I got my name badge. And then they said, 'Well, we offered you a professorship.' I used to be an endowed professor. This would be an adjunct at my age. I don't need an endowment. But they said, 'We're sorry to tell you that you have to start from scratch in the appointment process. So you're going to have to submit a new resume and CV and get letters of recommendation.' So if any of you want to write me a letter of recommendation, I'm open for that. But I've already earned my keep at Duke University in my first week on the job. You see in this picture, I got courtside seats for the Duke-NC State basketball game, and the woman sitting next to me there is Lydia, my wife of 52 years. We were enjoying the game. It was a very heated, sweaty game, and all of a sudden, Cooper Flagg, this 18-year-old freshman who's worth, I think he's getting 12 million a year as a freshman in college, came flying through the lane horizontally and landed in our laps. We caught him and saved the Duke University team. And it turns out I did Dr. Radio for Freddy Fight, an old friend, last week. He said, 'Send a picture that tells a story.' So I sent this picture. It turns out this is copyrighted by ESPN. It's not allowed to be shown for commercial purposes. But at any rate, this is a true picture. Now, some of you who know cardiology well may recognize this person right here. Now, it's well known in Cameron Indoor Stadium, the students have to stand. They're in bleachers, like old-fashioned high school bleachers. They all have to stand. This is a student section. This is Dr. Chris Granger, who's about three years younger than me, who was faking being a student so he could get a seat at the game. But we caught him red-handed here on ESPN.
So, just also by way of background, and let me just warn you, I'm going to flash through a bunch of slides. The purpose of the slides is really just to provide props to make a few points. I do want to leave time at the end for questions and comments that you may have. But by way of background, I've worked in a lot of industries over the years, a long time in academia, but touching on, I think, all the areas relevant to healthcare in one way or another, but most recently finishing at FDA. Just to again point out why I may appear to be bewildered, I just finished three years of overseeing the regulation of between a fifth and a quarter of the US economy with all the industries that are related. Now, most of you think about medical products, but the biggest part of the FDA as a singular entity is the food part of the FDA. The F in FDA actually does stand for food. We talked a bit about this last night. The Agriculture Department regulates barnyard animals and catfish. All the other food supply elements from the farm all the way to restaurants are regulated by an ecosystem overseen by the FDA, but involving states and counties and all sorts of other things. Also, through new legislation, we now regulate — we have the Food, Drug, and Cosmetics Act. So we've always regulated cosmetics, but the FDA was just given a lot of authority because cosmetics is now a $60 billion a year industry with a lot of products that have very significant health effects and cause a lot of concern. People don't talk enough about the animal part. The FDA has a Center for Veterinary Medicine, which regulates animal drugs, devices, but also the use of animals in food. And very importantly, between the plant and the animal part of food is the development of the technology of gene editing, which, as all of you know, is very important for medicine, but is really one of the very most important areas of development now for creating a sustainable food supply for the planet. And of course, you all know about drugs, you all know about devices, but of course, AI embedded in devices is an enormous growing area right now. And of course, biologics, where gene editing applied to humans, in addition to cell therapy and many other things, are coming along. And the last act that was added to the FDA was tobacco, which people tend to think the FDA has been regulating that a long time, but it was really Obama's first year that tobacco was added to the FDA portfolio. So we have a responsibility for a lot of things; it's a bit overwhelming. And if you think about not just the products that are regulated, the mission obviously, number one, is protecting public health. Number two, this just mentions the special role of tobacco. Everything else the FDA regulates is presumably an industry trying to make products that are useful to people and improve health. Tobacco — the only mission in tobacco is to reduce the number of people who are killed or disabled by tobacco products. There is no positive side to the regulation of tobacco. But the law specifies that you can't eliminate tobacco; it would be illegal for the FDA to do that. But right there with safety is also speeding innovation. So this is this balance that goes on throughout society, and the question is always, are we getting that balance correct? But the second bullet there is very important. I call it just explaining things to people, and this is an area that is completely overwhelming. I'll say a lot more about it in a bit, and how important I think that all of you wake up to what's going on in this regard — that is, what is the information that people are actually getting about medicine and healthcare. I probably don't need to say anything more than cod liver oil and measles for you to get some idea of what my concerns are. And then the one that was impossible to explain, my first time at FDA, people were like, 'What are you talking about?' when I pointed out that a significant part of the effort at FDA goes to preparing for the next catastrophe. And it could be a hurricane, it could be a tornado, it could be a nuclear catastrophe, it could be a pandemic, but you can't just react to that unless you've got considerable thought that goes into the response to emergencies, which is a cross-government effort, but very important roles for FDA to play in that. We were just talking before we started with Dr. Climate about the battles that went on over normal saline when Baxter, for some reason, decided to put 60% of the normal saline and other low-cost infusion materials into one plant in the mountains of North Carolina, and then it was essentially incapacitated by a hurricane. Dealing with that is an FDA responsibility, including emergency importation of products from other countries in situations where you don't have the usual safeguards in place.
Okay, here's the main thrust, and I will admit I am confused right now, and I'm trying to figure out exactly how to talk about this. So you're a test audience for the point I'm trying to make. But the basic point here, I'm 100% sure I'm right about. We are in the throes right now of a battle that's going on between the old traditional view of medicine and healthcare as a profession with the values. If you go to the lower left-hand corner: prioritize patients over financial gain, upholds ethical standards and professional integrity, values continuous learning. I would bet we would all say that we hold these values dear. But I believe if you look at what's happening in American medicine in particular, the lower right-hand corner is dominating the lower left-hand corner: emphasis on financial performance, operational efficiency, navigating regulations and market forces. And these two, I think the data speak for themselves. It is not working in the US right now. The system is broken. It's not delivering what people need. And I think the battle is going to go on because of AI over the soul of medicine. I'll just cut right to the point. When it becomes the case that you no longer have to do any hunting and pecking or typing or writing as you see patients in the clinic, will the bosses tell you to see two to three times as many patients, or will they tell you to actually spend time talking with patients, which is what they clearly want you to do? They know you're not doing it right now. All right, so now we're going to race through it. We got some tremendous opportunities, just amazing opportunities. And one of the great things about being FDA commissioner is you get to see it all before it happens. You're basically looking at new products being developed throughout their entire life cycle. And all these things on the left-hand side are happening in ways that were unimaginable just a few years ago. But we got big impediments to getting this right. And I'll talk about each of these in a little bit of detail. And then in the midst of all this, as if it wasn't hard enough already, this is — I asked Gemini to create a picture of two people arguing about paintings on the second floor while the house is burning down. And I think that's a large part of what's going on right now about some of the details, where probably a lot of you are spending your time trying to figure out how to run your own operations. But the very infrastructure that's supporting your work is in the process of being destroyed as we speak. Or another way of saying it, this is the analogy that I've used since the election to describe what's happening. And I've learned that almost 100% of Americans know the first verse of Humpty Dumpty. But it's pretty depressing because it ends with all the king's horses and all the king's men couldn't put Humpty Dumpty back together again. And I think if you go all the way to the last verse, which I've highlighted here, there is a silver lining potential because if you think the system's currently broken and it needs to be fixed, I believe we're in the midst right now of a deconstruction of the entire system in ways that you haven't quite felt yet, but you're about to. In places like this, I felt it with my former employees, many of whom were fired on the spot with no warning, in the midst of a semester of school, with three children in debt, one hour to clean out the desk, 30 days of salary, and no benefits after that. We're talking about people with advanced degrees in things like biostatistics, computer science, bioengineering who went to work for the government because they believed they were helping the American people. But if you read the front story in the New York Times today, you'll see that universities are now the next big target, and big health systems are right in there in terms of cutbacks and the amount of money that's being given out.
So before the house was burning down, it already looked bad enough. We have the worst outcomes of any large high-income country, but we spend a lot more money. And I don't have time to go through all the pictures here, but this is sort of the best way to display it, I think. It's updated every year. If you look at the lower left-hand corner in the early 1970s, US and all other high-income countries were sort of glommed together. If you plot life expectancy versus amount of money spent per person, as the years go by, you'll notice that all the countries sort of move up to the upper left-hand corner together, except for one outlier. That's the United States, which is a uniquely bad business deal, spending twice as much money for very easily identifiable — you might say that we're exceptional. We have the worst outcomes by far in terms of life expectancy and other health outcomes. The latest update was kind of interesting because the impact of COVID — you'll notice we're sort of like a hurricane that did a twist there, as we actually had a drop in expenditures when people couldn't access healthcare, but also a drop in life expectancy, and now it's sort of back to where it was, but we are distinctly worse than any other high-income country now. Now, back to the annotation here. It's really interesting that we keep saying that we can't have a universal healthcare system in the US, but every other high-income country has somehow figured out how to do it. Now, is that the reason that these differences exist? No one's done a randomized trial, but it's something that I believe is worth thinking about. But these bad outcomes, you all know this, are not uniform. Those of us sitting in this room will do pretty well relative to other high-income countries. And I like to think of this now in terms of three categories of disparities: the traditional ones — sex, gender, race, ethnicity. And you know I'm not worried about talking about this. I was a political appointee. I'm already a target. It's fine. But pretending that these things don't exist is not going to make them go away. There's plenty of history to tell us that. But the big ones that are emerging as dominant in the US are wealth and education. And of course this is intimately related to exactly where we live, the neighborhoods that we live in, down to the neighborhood level. Big differences in health outcomes. So if we look at the traditional ones, there are a thousand pictures of this. You all are aware of it. Even during the early days of COVID, it played out. We have a worse life expectancy than poor countries, but if you're Black, it's even worse. I also here like to point out, in light of a lot of the discussion, a lot of people I found out are surprised to learn that it's actually men who have worse health outcomes than women. There's a five-year difference in life expectancy, and it's widening right now, especially in catastrophic outcomes in young men. So while women's health is very important, I'm not arguing at all for reducing our emphasis on that. If we don't pay attention to men, we got big problems to deal with. So here's a look at where people are dying. And I'm from South Carolina, so I feel perfectly okay saying Texas looks really terrible. You guys are really bad. You have terrible health outcomes. And but you know, so does the state that I come from. This is not a uniform distribution of health outcomes. But you know, I think this slide is really interesting. Our disparities in wealth are growing, as you know, between wealthy and poor in the United States. But the health outcomes related to income are exponentially increasing. That is, the more money you have, the better you do. Now, this shouldn't be a big surprise to anyone, but also very important is whether you have a college education. An eight-year difference in life expectancy in this country between those who have a college education and those who don't. Now, I gave this lecture at the other place in Houston. What's the name of that place? Baylor, is that, I think, the other day. And there was someone there, Atul Grover from AAMC, and he pointed out that he had just written a paper about one of the big reasons for this, and I had actually read the paper, but I had not put it in my lectures in honor of Atul. I think this is worth — I'm not telling you I know what to do about this, but if you look at US versus other high-income countries, you'll see much higher rates of alcohol use disorders, drug use disorders, and physical violence by firearm. No big shocker there. What's important from the point of view of life expectancy is these things differentially affect young people. So if you commit suicide at age 20, the effect on national life expectancy is obviously much greater than if you die of coronary disease at age 80. And so if you just took care of these three problems, you'll see there in the red how far behind the US is from other high-income countries. But if you took care of these three problems, it would make up about half the difference. About half the difference. That's worth remembering. So again, I'm not telling you I know what to do about firearms. We are in Texas. I want to get out of here alive. But I'm telling you that we should do something about it because it's differentially impacting the same — the people who own guns. Having access to a gun is a huge risk factor for a violent death. But the other 50% is mostly cardiometabolic stuff. So we can't get away from it as cardiologists. And I believe we really need to tackle it. And no surprise, based on what I've said, I don't think building big buildings in the middle of a city is going to be an answer to this problem. Now, I'm not arguing against having high-tech stuff. I think it's really important to have that too. But we better pay attention to this other part. If we look at the details here, the underlying issues are things that we know a lot about. And one of the great things about now is that for every element of the cardiometabolic — now the only case where it's not generic and cheap, of course, are the anti-obesity medicines, but that's about to get better as there's a proliferation of products on the market. I had the chance to see all the ones that are in the pipeline. It really is a dramatic thing. So we have the means to deal with this underlying catastrophe going on in the United States. We're just not doing it. American Heart has done a great job, I think, of calling attention to it. It's pretty simple stuff. The simple eight, easy to remember. You don't need high-end computing to make it understandable. But if we look right now at the risk factor profile of our younger people in the United States in the latest report from the American Heart, we're going to see a very significant increase in all the bad things that can happen related to cardiometabolic disease. So the good news, if you've built big buildings and want to do high-end specialty care, is there's going to be plenty of business. Don't have to worry about that. You'll have plenty of business going forward. I would argue that the increase in business is so vast relative to the number of people we have to provide the care that it'd be a pretty good investment for us to try to do something about preventing all this, and you would still have plenty of business at a place like this. The patterns for cardiovascular disease look just like the national patterns for death in general. Again, Texas stinks. So does the rest of the Southeast where I'm from. And of course, the cardiologists tend to glom into places like Houston and Research Triangle Park, not in the places where the need is the greatest. So if we think about dealing with this problem, it's going to have to involve something other than pretending that people are going to drive three and a half hours to get the care they need for something that really requires attention every day to lifestyle habits. I have to acknowledge the data looked a little bit better last year. This is just a look at the CDC data. This is when data was on the CDC website, by the way. There's an interesting article today. The academic community has now completely recreated the CDC website for what was there on the day of the transition to the new administration. So all the lost files and things are now going to be accessible through academia, and it's going to be interesting to see. But this small improvement you can still see is — it's not going to get us anywhere near where we need to go to be competitive. If you follow streaming TV and follow Ted Lasso, you would know that if we were in this place in a soccer league, we would be relegated to the next league down. And in fact, we're sort of nearing the middle of the pack of middle-income countries now in terms of our health outcomes as a country. On top of that, the public is aware that we're not doing a good job, despite all of our advertisements and glossy pictures and things that go on TV and our profession of being patient-centered health systems. 66% of Americans, this is two months ago, would agree with the statement, 'I have to be responsible for my health because no one else seems to care.' Now, if we were really patient-centered health systems delivering holistic care, I don't think that would be the expected response from customers. And part of the reason is over half of Americans couldn't raise $5,000 if they had a health emergency. Now, I don't know about your emergency department, but at Duke Hospital right now, one visit to the emergency department is likely to be over $5,000 if you don't have a good insurance plan. Well, what's missing? There's this thing called primary care, which we just don't have in the US. It blew me away about eight months ago as commissioner. I made a visit to Mass General Brigham, our ultimate high-end academic medical center. They were building — they're building this huge cardiovascular and cancer hospital, inpatient hospital. They had 100,000 people on their books who could not get a primary care appointment in their own system. I don't know what it is here, but everywhere I go, people are saying, 'I can't get in to see a doctor, period. The waiting list is forever.' And ironically, I got worked up about this because part of being an FDA commissioner is you're at the table with the rest of Health and Human Services, CMS, SAMHSA, all those organizations. And you interact a lot with USAID because our supply chains are so intertwined with globalization that's happened. I got to know Atul Gawande really well, who was running USAID. Little did I know that this would be eliminated as an agency by the incoming administration. But one of the points he made to me was there were a whole bunch of countries that we used to call third world who had terrible life expectancy compared to us. And USAID invested in a primary care system in every one of those countries. And now many of them are exceeding us in life expectancy, although they're still impoverished compared to us in terms of the amount of money that people have. Or another way of looking at it, and these are his slides, they're matching us in life expectancy with as little as 300 bucks a person for healthcare. Well, how are they doing this? It's called putting clinics into communities where people can physically interact with people. And another interesting part of what I got to do in the job was to interact with the big guys, the payers and all, because they're all interested in new products coming out and what they're going to cost. So a friend of mine who runs a JPMorgan healthcare system — I was on a plane with him a couple of months ago, Danny Mendelson, and he said, 'You know, we tried to do a digital primary care clinic because JPMorgan employees are highly educated. They're wealthy. We thought they would love it. It was a complete failure.' But he said what really worked was we put a primary care clinic on the first floor of our biggest office building, and it's a tremendous success. People love it. As they're coming and going to work, they can stop in and get their blood pressure checked, have a chat about what's going on and things that they need. Well, I don't think primary care is going to be enough either because if we tried to recreate what's happened in low-income countries here, it would take decades, and the whole system is configured not to deliver that product. So another way of saying it is just because it works elsewhere, that almost guarantees you that America is not going
to do it. It's just the way we're configured. So, we're going to have to integrate the concepts here with something that provides a context for people to improve their health the way they do other things in life in this country. This is at least my belief and I welcome challenges in the Q&A. But the biggest threat to this in my view is misinformation. I've been widely quoted as arguing that misinformation is the leading cause of remediable death in the United States. And I still believe that's true. There's no way to empirically prove it. But, you know, for example, not getting a measles vaccine and then trying to treat pneumonia with cod liver oil would be an example of tremendous risk. But just look at how many people would benefit from statins who are still not taking them. And I could go on and on about this, but it's important to remember that there's just a lot of misinformation, but there's also disinformation which is purposeful. And there's malinformation, which is not only purposeful, but very specifically intended to harm people. And our international adversaries are very busy finding divisions in the United States and promoting malinformation because if you wanted to kill Americans without declaring war, the most efficient way to do it would be to get them to not do things that are beneficial for their health.
Uh-oh, the Doge system may have shut down my... There we go. So, I'd urge you to read the National Academy of Medicine report that just came out about this. It's very long, so you may want to just read the recommendations, but it makes some of the same points that I've made, but gives a lot of detail about the reasons and the understanding of it. Then the three books that if you like to read books, I would highly recommend. These slides will be available, so don't worry about taking notes. I particularly like Francis Collins' book because he's an evangelical Christian and a great scientist. I have a similar background. I'm not an evangelical Christian right now, but my grandfather was a Baptist minister, so I understand a lot about where all this comes from. But Harari's book — Francis's book is down-to-earth, simple. Harari's book is almost impossible, but it's worth reading if you really want to get a sense of what goes on. One of my favorite parts of the book, the thesis is basically whenever there's an explosion in the availability of information, the bad guys win for some prolonged period of time. And the part I like the best is a vivid description of the printing press. If you don't think the printing press was a good idea, raise your hand. All right. We all think printing press. Neil, you don't. But what happened with the printing press is when it first became available, there were two centuries of the dark ages. And it was mostly used to promote the concept that your next-door neighbor is likely to be a witch. And it's very vivid. The printed material said, 'That woman next door to you, she's a witch and she's going to capture you and cut off your penis.' Literally, that's what it said. And this got people worked up. So there were a lot of witches that were hung in Europe during this time and it sort of culminated in the US in the Salem witch trials which everyone has heard about. Eventually the good guys caught up. So this is Francis's very simple diagram which I think is worth keeping in mind because there's a very small core of information that he called necessary truth. And I agree with that. 2+2 is 4. If you say 2+2 is 10, you're just wrong and there shouldn't be any acceptance of an argument about it. But that's a small amount of all the information that we have. And then there's firmly established facts. These would be things that would be like grade one recommendations, class A recommendations in our clinical practice guidelines. If your artery is occluded and you have ST elevation in a compatible clinical scenario, the artery should be open. We proved that by doing randomized trials in hundreds of thousands of people. But even firmly established facts can change if the context changes. There'll be new therapies that come along that might, or the disease context changes. And then the biggest bodies of information are the areas of uncertainty where we just have opinions. I've always said I'd rather have an expert opinion than someone that just thought about it 10 seconds ago and went on a podcast. But people growing up today don't necessarily think about it that way at all. And then the area of pure opinion which is most of what's on the internet. If you actually analyze the content of the internet, it's mostly just pure opinion, anybody's idea. And I think Francis makes the argument and I completely agree that a mistake that we've made is believing that because we're an expert in necessary truth and firmly established facts that makes us an expert in opinion. And the best example is the Nobel Prize winner. I don't know why someone who got a Nobel Prize for some obscure area that turned out to be very important is assumed to be an expert in everything else related to humanity and mankind. In fact, I think it's definitely not the case if you look at what a lot of Nobel Prize winners have done in other areas.
But the net result of this information ecosystem that we're in is people are losing confidence in the basis upon which you're allowed to build buildings like this, provide the care that you care, and assume that you're going to get paid to do it. So, one of the biggest drops in confidence right now — the drop in federal agencies happened a while ago, but what's happened lately is a drop in confidence in our health systems and professions related to our health systems. And this is in a free fall right now for a whole variety of reasons. For example, you're recommending vaccines. Someone in authority now is saying use cod liver oil and vitamin A and exercise a lot. It's going to prevent you from getting infected. But, you know, if you think about it, you got a lot at stake in what's happening in the information ecosystem because it is a basis upon which professions historically in a place like the United States have been given special privileges and ability to put up a banner saying that we are special and we have knowledge that other people don't have. Now the fringe area that I don't have time to go into but I'd urge you to think about a little bit is advertising. Bill didn't mention it specifically, but I spent five years at Alphabet, the parent company that owns Google, and Verily and a bunch of other subsidiaries. And the engine that drives Google is advertising. So, I really was in the belly of the beast. Advertising really is drug advertisement that goes straight to the hippocampus. That's the best advertisement. You want to bypass the discerning part of the brain, the cerebral cortex, and you want to get to the primal part of the brain to create a desire to use a product which is independent of whether that product is actually useful or helpful to you. And the methods of doing this are very well known. You're not very good at it in traditional health systems. But this effort then to create an environment where people are immersed in reliable, useful information and they have a human being to talk to and a primary care system that takes care of the basics. So that by the time they get into a situation where they need someone like people in this building is really running up against enormous headwinds that are quite obvious right now. The first one is financialization. Now, the greatest use of AI in medicine today is what? It's to identify the people upon whom a profit can be made. It's segregating patients into profitable patients and unprofitable. It's also measuring what you do. I was learning last night about some of the fabulous new systems that are going in here that will enable the administrators to track you every step of the way. And so I think that's a good thing, but it's only a good thing if the output is specifically meant to improve patient outcomes, not just to improve the profitability of what you're doing. Someone last week when we were talking about this said, 'Yeah, doctors and nurses, they're like cattle with the little things on their ears so they can be tracked everywhere they go.' Well, so the question is, what's the purpose of this and how are we going to use it? These are three great articles that give you the darkest side of this, but in my view, it's very realistic. How else could we be spending $5 trillion a year and get the worst health outcomes of any high-income country? And suboptimization. We talked about this ahead of time. How much of your time do you spend arguing with people in the same system to optimize what you're doing without any knowledge of what that's doing to the system as a whole? So, the argument about who gets a bag of saline when saline is short between the emergency department and the cath lab. Well, the strongest person wins right now, usually the person that's going to get the most money for doing what they do. But what does that do to the patient who's really looking for a solution to a health problem which needs to be holistic? This article, if you get a chance, I'd also recommend you read. It's kind of a crazy article. It's about a man who's diagnosed with pancreatic cancer, undergoes a great Whipple procedure, gets all the follow-up studies on time, he's feeling fine, then someone looked back at his record and the pathology did not show pancreatic cancer. And the point of it was the whole system worked well in every little component except the one part that was most important because no one was looking at the whole picture. Everyone all along the way was just looking at their part of it and doing a really good job. So this is a well-known business concept. It doesn't work, but it is the way the American health care system currently works.
One little reprieve of really good news here and I don't have time to talk about in detail. mRNA platforms for new biology are going to make a huge impact and make things possible we couldn't have imagined, like once-a-year treatment of hypertension and hyperlipidemia, and gene editing works, which is bringing hope to people with thousands of rare diseases that were previously untreatable. These things are also going to cause interesting problems unless the system overcomes the barriers that I'm talking about. I'm going to skip over this part. This is my usual plea that part of the mission of the profession should be to generate knowledge. Now, the new thing I came up with last night is that the clerks at Walmart do more research than your average clinician in the US right now. Every purchase at Walmart goes through a scanning system. Analysis is done on the fly. It's fed back. It's learned. Now, the purpose of learning is to increase the profitability of Walmart and to make the customers happy. In our health systems today, I don't know about you, but as I've talked to a lot of people, you're being pushed to run on a treadmill faster and faster with less feedback of integrated information that helps you learn about what you're doing and practice better. The good news is this is very fixable, but it's only going to be fixable if we do it as a conscious effort and have a professional ethic that fights back against a purely financially driven system. The only point of this slide, I'll just say one word about it. I have to admit it was always interesting to me when I was commissioner, it seemed like everybody in the audience had a list of things that FDA should be doing and shouldn't be doing. And a lot of it for clinicians was, 'Why don't you require that companies do all these studies?' And the answer is because the law says we can't require it. And so once a product is on the market — and remember, for a medical product to get on the market the company has to show the benefits outweigh the risk for one indication and one population for some specified period of time. Everything after that is medical practice. It's up to you. And so no one owns that space of how do we get the information that we need to know which products are better, when they should be used, how long they should be used, what the right dose is. Remember, there's no requirement for the right dose to get on the market. It just has to be better than nothing, whatever the dose is that's chosen. And so we need powerful places like this to get together and develop a system that routinely measures things and does the kind of studies that are needed to understand what you need to know to practice. All right. So the great news is when I started, this is where all the information was. A great intern was someone who could find the journal article and make a copy of it on the copy machine and hand it out. Now we have agents squabbling with each other about what the right answer is in AI and this is moving so fast. And I had a real privilege to be able to watch this happening from the point of view of FDA. There's no question that this is already working, but it's going to work better and better. The question is, AI like all equations has a dependent and independent part, and if this is all this information, the question is what's the output that we're trying to get? Is it purely financial or is it some element of better patient outcome in this that can be measured? We are meant now, I think, finally on the way of moving from this, which was my depiction five years ago of healthcare information — every little part was self-optimized, but no one could get all the information at the same time. It is beginning to look more like this. And I would guess that in Houston, like most places in the US, if it's an individual patient, you can get everyone else's medical records one patient at a time through health information exchanges. But doing this at a population level is what's going to be really needed to get the system to hum across the lifetime of a patient over time.
But so far almost all of these advances have accrued to the benefit of people who already have money. And this is another great quote from the pandemic: 'Technological solutions rise into society's penthouses while epidemics or diseases seep into its cracks.' At Google, no matter how much effort we put into interfaces, the wealthy and highly educated — if it was good, they took advantage of it right away. Most of the rest of America was left behind and had trouble discerning what was really good from what wasn't. I'm almost done. Let's see. Here we go. So, what would happen if instead of focusing our AI on very high-tech stuff — and again, let me say I'm not opposed to that, hearing about your new hospital and how all that's going to work. It was amazing to hear about it. But what if we focus the attention on the basic things that I've just described, which is where our biggest deficit is in this country? This happened in aviation because there was a time when every time an engineer thought of something new to measure, they just created a new gauge and it was stuck in the cockpit in no particular order. Well, you can imagine trying to fly a plane if you didn't know where all the measurements were and there were these new things coming in all the time. So, they did a project to deal with the information overload called the glass cockpit project that took about two years of human factors analysis to come up with a standard configuration so pilots could fly the planes without being confused. And we've started to work on this at the FDA as I was leaving. I hope this project is continued. But the goal is to get the industry instead of focusing on just pleasing the high-end customers to focus on what's the integration of information that can enable a person at home dealing with a primary care clinician of some kind or a public health system to navigate the day-to-day activities that need to be navigated to take care of health. This also has applications for very specialized care, like envision an elderly person with early-onset dementia who desperately wants to live at home more, which is 100% of elderly people with early-onset dementia. It's not hard to imagine now an environment of digital support and artificial intelligence that could make this much better.
So, this is also another ironic one, just like AI. Elon Musk was not the first person to come up with the fork in the road analogy. All of my former employees got a — I think you've heard about this — got an email message saying, 'We're at the fork in the road. You have 24 hours to give a list of five things that you did in the last week,' including VA physicians, which I think is kind of ridiculous. But I think we are at a fork in the road now whether digital technology is either going to accrue the benefit of a smaller group of people who will increasingly do better or accrue the benefit of the kind of problems that I'm talking about. Next-to-last slide, this is Steve Steinbrenner's depiction according to ideologist. Many of you probably don't know — if you know Steve, many of you probably don't know him, but if you know him, he was one of the last of the chemical engineers at Kodak. He actually had a degree in chemical engineering. His job was to make chemical photography compete with digital photography. Well, you know how that story ended. And so, I think we are now in the midst of this revolution that's in full force. And the question is how is it going to play out? And to me, the key question is the existential one. Is it going to accrue to improve health outcomes or is it going to accrue the current trajectory that we're on of improving the financial well-being of certain people at the expense of others? So with that I'll stop. Happy to entertain any questions. There's nothing you could say that would be more offensive than having gone through two Senate confirmations and other things that happened while I was commissioner. So, don't be shy.
