Dr Marshall scrutinizes the history of US drug price negotiations and what might come next as the country changes leadership.
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Is the Inflation Reduction Act a Threat or Opportunity for Oncology?
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[00:00:05] John Marshall, MD: Hey everybody, John Marshall live from Washington DC where all the action is happening. A lot of moving vans are likely to be coming here soon as the new party comes in to take over maybe everything. We're going to have to see how that goes. We're all living in this crazy state of uncertainty about just how much. Are they saying is going to happen? But we'll see. That's our future.
[00:00:34] But what I really want to talk about on this episode of Oncology Unscripted is the beginnings of a discussion around health policy in oncology and the reason I'm bringing this up is I just recently came across my radar, something called the Inflation Reduction Act. Well, sure, I knew about the Inflation Reduction Act, but I didn't know how that was going to affect cancer. And then I started to think about, yeah, I do. They're going to negotiate drug pricing on cancer. And there's been this big turmoil about we can't do that. It'll break the system. We need the fixed drug pricing, et cetera, and I want to talk about that because it's starting to be put into place, and it might actually get wiped off the map in a couple of months, but maybe it won't. And I wanted to talk about it because it will affect what I do for a living, and that's to try and develop new drugs for cancer.
[00:01:29] But in order to do that, let's start by at the beginning of when the whole thing needed to be created in the first place. And that is go back to 2003 Bush II, Bush II to put into place a health modernization Medicare Modernization Act, which at the time was praised. Now, remember where we were people with Medicare didn't really have drug benefits. You went and paid cash at the pharmacy. But drugs were getting more and more expensive. And so, seniors weren't able to afford the drugs. And so, we needed to figure out how US health care was going to cover those drugs. And this was the deal that was cut now out of that deal. So, seniors got access to drugs. But for the tradeoff that always happens here in Washington, D.C. Now, the first one was that there was an agreement that we would not import new drugs from other countries. So, in other words, you couldn't manufacture it in Canada and then ship it across the border at Canadian prices. We weren't going to allow that. So, the borders were closed to import so that we could save the price structure here in the United States. And with that rule came another corollary is that we could not negotiate drug pricing with the manufacturer. Whatever they said was going to cost, that's what CMS would pay. And as a result, that was when we could no longer judge value as a nation. So, if you can't connect magnitude of benefit, which is what the FDA judges, did it work or not, to the cost, that's what CMS has to do, you can't judge value. Right? There's no way. Okay, it'll cost $100,000. Okay, but what do I get for that? Well, it could only be 6 weeks. And that would be enough for it to get FDA approval. And Medicare would have to pay. the third component was something called 340B pricing, and that is institutions like mine and many of the institutions around the United States pay a reduced amount for the product, get paid by insurance companies, the delta, and with that extra money that we get as a healthcare institution, we're supposed to provide All those other things that cancer care delivers. A nutritionist, a social worker, nursing support, et cetera, that don't have any billing infrastructure for it.
[00:04:08] And so that non negotiated price, the rising cost of cancer drugs, and this 340 B pricing is our current economy. And with that, all of our industries more or less dependent on that pricing structure. So, the inflation reduction act is a threat to that, right? Because if we're going to start picking and choosing drugs that can be negotiated on price, then how does that affect the revenue stream?
[00:04:37] And how does that affect the reimbursement into research? And so, our whole series on the next few episodes is going to be focused on the Inflation Reduction Act and what it does now, and what it could do in the future. And why we're worried about it. We hope to get some good folks who are in the middle of this discussion to talk to us about it. It's a fairly sensitive subject. So, we are hoping for that. So, stay tuned to future episodes.
Cancer Care in America: Equal Access or Uneven Outcomes?
[00:05:05] But as part of this episode, I wanted to talk about yes, U.S. health care, but I wanted to talk about. Does everyone get the same U.S. healthcare? Now, the reason this has become important to me is that we just did a study here in Washington, D.C. between two of our main hospitals that I work in. They service very different patient bases and neighborhoods. They're both busy cancer hospitals. They both provide specialized cancer care. That's important. But one, quote unquote, has a lot of issues with social determinants of health. Barriers to access to cancer care, because as we've talked about, cancer care is complicated to receive, it's complicated to give, and if both parties are doing okay, then it's okay, but if one is challenged, then it's not okay, right?
[00:05:54] So what we did is a big study of a thousand patients with colon cancer, and actually extracted from their charts, 400 from one hospital, 600 from another, and believe it or not, We were expecting to see a difference in outcomes that the social determinants of health were in fact going to affect the outcomes for those patients. But not only did we see no difference, we saw that. In fact, our record here in our health care system was better than published national averages. Molecular profiling, time to treatment, survival, all the key points we want. And after an initial sense of pride, I'm like, well, wait a second. That is not what we were expecting, right? We were expecting there to be a difference because of the populations that we were serving was different.
[00:06:42] And so we then developed a new theory, which we are testing now, that can a general oncologist, nobody out there get offended, keep up. With everything that needs to be kept up with in every disease, and I think if you ask most general oncologists, they would say they do a very good job, which I would agree with, but maybe not as good as it could be. On the other hand, what if you live in a remote part of the world in our country? How far do you have to go to even find a cancer doctor or a place where you can get an infusion? So, we have this issue of general oncologists and remote access, right?
Bridging the Distance: Can Rural America Get Equal Access to Cancer Care?
[00:07:23] And so there have been a couple of, you know, announcements lately about new projects. There was 1 that looks like it was funded by ASCO and it's in rural Montana where they're going to use a hub and spoke model where there's going to be infusion sites around in the. and then they'll be in a remote country, but then there'll be centralized care. It's exactly how Canada does it now, all the doctors live along the southern border of Canada, right? Because that's the only place where there's not snow all the time. And they've talked to, using telemedicine, patients who live up further away. And then there are local nurses and general doctors who administer the cancer care. So that hub and spoke model we know works in the Canadian health care system.
[00:08:08] , There was recently Iowa, as you might imagine, great centralized cancer care, but how do they care for folks out and around? So, the University of Iowa bonded with Mission Cancer and Blood, 280 million dollars changed hands, but to basically deliver cancer care in a remote areas. Now this is great. This is what we need for our people and for everyone around our country is good access to cancer care.
[00:08:37] But what our little study may be hinting at is maybe this also needs to be done by cancer specialists. Should we begin to divide even general practice knowledge into its subcategories because it's gotten so complicated? The analogy I like to use is if I had a bunch of okay. And the answer is no, I can be an expert in one or two, but I can't know all the nuances of all the different board games. So we're going to have to figure out not only provide cancer care for everybody, but Through these kinds of networks, hub and spoke model, but how do we make sure that we're actually delivering the highest level of cancer care that we can so that our patients can get the best outcomes and the best and the right therapies on time, et cetera.
Is the U.S. Health System Designed to Fail Its Patients?
[00:09:30] So the last point I want to make about all of this health care policy. It really comes from a recent survey paper that looked at the different health care systems and outcomes around the world. And we always think, because we're the United States of America, that we have the best of everything. Well, we do have the best hamburgers that I'm going to give us. Maybe the best fried chicken, too. I would say that's probably true. Best bourbon? Yeah, I think we have that. But in terms of the best care and healthcare, when you look at the top, like richest countries, we don't. We're in fact, of the top ten, guess what number we are? We're the worst in terms of access to care. Bad health outcomes. Bad worse. So, 9th administrative efficiency. I didn't need to tell you that. Equity, we're 9th in that where we are. The best is what they call care process. So if you're in the system, we got all the bells and whistles, but we leave lots and lots of people behind.
[00:10:40] And so, as we think about going forward, we have the inflation reduction act, which is trying to make cancer care more accessible and more affordable for our patients. We've got administrative and economic pushback on that. We have a new administration that, who knows what they're going to blow up going forward. But we know for sure. One of their priorities is not equal access to everybody around our country.
[00:11:04] So as we spend the next couple of months reflecting on where we've been and where we're going, fingers crossed, that reason will prevail, that we will prioritize the patients in general. That access does matter that we want to level the playing field to health care as much as we can for all of our patients across our great nation. And I think with that, we will show how we can work together and how we can bridge our divides as we walk forward over the next 4 years. John Marshall for Oncology Unscripted.
Pandemics, Presidents, and Perseverance: A Candid Conversation with Dr Anthony Fauci
You know, I've interviewed a lot of people in my career, but I don't think I've ever had quite the joy of interviewing someone who, honestly, I think almost everybody in this country, there's some who don't feel this way, but, almost everybody, in this country who think is a real modern day hero, and this is Dr Anthony Fauci, and he has agreed to join us and talk about a few subjects that sort of near and dear to maybe both of our hearts and share them with us all. And on a second note, I want to welcome him as he's flying the Georgetown University flag behind him. I've been here on the faculty for 31 years and I'm not sure I've, I don't want to insult any of my other colleagues, but I'm not sure I've ever had quite so, such an esteemed colleague from my own university, join me. So, Dr Fauci, first, thank you very, very much for joining us today. And let me give my own personal Hoya Saxa welcome to Georgetown University.
[00:12:35] Anthony Fauci, MD: Thank you so much, John. Pleasure to be with you.
[00:12:38] John Marshall, MD: Well, you're awfully nice. Part of what has sparked my interest in talking with you just beyond all that you've been through and all that you've led us through over the years, is really some subjects that came forward in your book. It was really an impactful book. If you haven't gotten it yet, gang out there, it's called On Call. It’s a terrific book available on audio as well for those of you who like to walk and listen at the same time. It's really an extensive review of your own life and the impact that you've had in your own reflections on very, very dramatic moments in medical history. And I wonder if you just start by kind of sharing the sort of inspiration to write it and sort of the emotion and what it took to stop and get all of that down.
[00:13:25] Anthony Fauci, MD: Yeah, well, thanks, John. I decided to write the book because when I came to what I was projecting to be the end of a 54 year career at the NIH, Almost 40 years of which was as the director of the NIAID, which positioned me to essentially be in the eye of the hurricane in the evolution of, as you mentioned, the most impactful pandemics in modern history HIV in the early 80s and through the next 40 years, and then followed by COVID-19.
[00:13:57] That started, at least in the United States, we had the impact of it in the early months of 2020. When I decided I was going to step down, I thought it would be important, given I had the unique experience of this, journey through these two major pandemics, but also in between advising seven presidents of the United States from Ronald Reagan through the Bushes, through Clinton, through Obama, through Trump, and then finally the seventh. when I spent two years as the Chief Medical Advisor to Joe Biden. I thought that that was such a unique experience. My thoughts were two-fold. One, I thought from a historical standpoint, I thought it might be useful for people to see what that was like to go through the early years of the pandemic with HIV and then throughout COVID, but also hopefully to serve as an inspiration for younger individuals who might have an inkling they might want to go into science or medicine or public health. And my description of the early years I believe were important because right now with HIV, we have a single pill with three antiretrovirals that can put a person into complete remission by bringing the level of virus to below detectable and keep it there, essentially indefinitely.
[00:15:27] But I hearken back in the book, in the memoir, to those early years from 1981 through the mid-80s, the late 80s. And the early 90s, when we did not have adequate therapy, and I found myself as a physician who, prior to HIV/AIDS, was rather successful in developing remission inducing therapeutic protocols for auto inflammatory disease, where most of my patients who thought they were going to die actually went into remission, then entering the arena of caring for and studying persons with HIV. I describe it in the memoir as the dark years of my medical career and the stress and the strain. Of seeing virtually all your patients, mostly young, otherwise previously healthy gay men who are dying terrible deaths, no matter what you did. And it was like putting bandages on hemorrhages. You know, I described in the book, I still to this day have flashbacks of what I call a version of post-traumatic stress. Because. When you were taking care of these people early on in the early 80s, you could not get emotionally involved in it because you had too much work to do, and your job was to take care of the patients. So, you suppressed it. It only was years later when you reflect on what you've been through that you understand that you didn't have time to burn out because you had too many people to that you had to take care of. But it was an extraordinary experience, which was an important part of the book to describe those early years of HIV.
[00:17:17] John Marshall, MD: Yeah, well, and taking care of yourself was had to be last on the list because everybody else needed you and there were no, you know, it was sleep, eat and take care of people. I remember in 1988 when I became an intern here at Georgetown walking the halls and those floors still exist. There’s new tile, but the floor still exists. And, you know, I remember the faces of the young men that you describe in there and being the guy who had to go in the gown and get the blood because we didn't have phlebotomists back then and being afraid actually to have a needle in my hand and have an HIV patient that I needed to get blood on or to put a line in or something like that, but at the same time they were alone and you wanted to be there with them because the way the rules were in hospitals as they frequently couldn't have visitors and certainly that was traumatic for me and I, like you say, I probably tucked that away. Then I decided to take on the easy task of trying to cure GI cancers. Not done nearly as well as you've done with viruses
[00:18:16] My experience was then my wife gets breast cancer. And I thought she was going to die. And now all of a sudden I knew what it felt like to be a caregiver or to be a patient. when in fact, I had probably tucked that away for many, many years. and when it, then I tried to, back to we're busy and we got to cure people, deliver that care for every cancer patient that was here. I realized there was no way that you can deliver that level of cancer care, the cancer care that we received as patient and caregiver. I couldn't turn around and give that to everybody who walked in the door. And that was in essence my source of burnout because I was feeling the impact. I was feeling the shortcomings, and actually had to get away for a while. And, and part of our book reflects on that. I think the young people today, and I would love to hear your sort of comparison because I experienced both, you experienced both pandemics, but a lot of our gang around here, you know, they cut their teeth on a pandemic. The interns and residents were on call, and you know, burning their clothes at their door on the way home in that same sort of way we felt with HIV.
[00:19:22] Do you have a sense of how they might be different or how they were different for you, the two experiences?
[00:19:28] Anthony Fauci, MD: Well, yeah, they were different for me, John, for the following reasons, that through the early years of HIV, even after I became Director of the Institute, I was very actively involved in the individual care of individuals, which led to that very stressful, emotional experience that I mentioned to you a moment ago. When it came to COVID, for me personally, it was a different experience because I was in a position of public health influence where I was, you know, as part of the coronavirus task force in the White House, making decisions that were difficult because we had an evolving outbreak that was not just selectively impacting a subpopulation, it was global that everyone was at risk. So, we had a true global health and domestic health catastrophe with COVID, and we had to, to the best of our capability, make decisions about what public health recommendations would be that would involve everyone, not just a small subset of people.
[00:20:45] At the same time I had the responsibility, together with the pharmaceutical companies, to develop the vaccine. And I could say that was one of the things that we're very proud of, is that my group at NIAID, the Vaccine Research Center that I established 20 plus years ago, was the group and the organization that developed the vaccine the highly immunogenic immunogen that partnered with the mRNA platform to create a vaccine in 11 months, which as you well know, that is a fraction of the normal time it takes to develop a safe and effective vaccine, which usually averages, 7 to 10 years. So, a combination of major investments on the part of the government, the scientific input from my group, and the incredible work that the pharmaceutical companies did. We had a vaccine in 11 months. So that was very, very different from the multiple years it took before we could get a drug for HIV. Remember the first patient that I admitted, with HIV, was in 1981. The first drug that had any effect on HIV was 1987, and it wasn't until 1996 that the triple combination of drugs were made available, which actually dramatically diminished the viral capability and viral load.
[00:22:18] John Marshall, MD: I used to say back in the day that the only reason the HIV success happened was that gay men, essentially, became very powerful self-advocates, and demanded this when there was probably a public sentiment that you were up against even then to do this.
[00:22:34] With the pandemic, even though you did have global support. You did also have to climb a hill over some who thought this was all some sort of conspiracy. We all know that, but so we are grateful for that. But it does require that sort of will to do it. But to your point, if the will's there and the science is ready for it, it can be done. And so to reflect on that, you coaching me as an oncologist, do you think that if the will were there and we spent the money that we are spending every year on cancer care and cancer medicine, if we spent it more wisely, could we in fact have better outcomes than we do now? What's your thought on that?
[00:23:15] Anthony Fauci, MD: I think so. I mean, if you look at the focus concentrated effort that was put into drug development for HIV, it is one of the greatest success stories of modern medicine. I mean, where all of your patients are dying from an infection that you just could not treat at all to years later when you have a single pill that can essentially drop the level of virus to below detectable and keep it there, not only saving the life of the person, but making it impossible for that person to transmit the virus to someone else.
[00:23:51] John Marshall, MD: at the time, we had like 90 percent accrual rate on clinical, everybody was on a trial, right? It was uncool. Not to be on a trial.
[00:23:59] Anthony Fauci, MD: Yeah, that's exactly what it was. I mean, and you know, you mentioned a moment ago, John, the importance of the AIDS activists in getting community involvement in everything from the design of clinical trials to make it more user friendly to them, to challenging the rigidity of the regulatory process to get drugs approved. Because the FDA process prior to AIDS was very well accepted. It provided safety for the American public, and it got drugs out. But it was ill suited to the emergent nature of HIV, where when someone had clinical disease, it was 12 to 15 months before they died, and interventions before they got through the FDA process would take six years, seven years. It just didn't work for them. So, they pushed back, and the scientific community and the regulatory community didn't listen to them. So, they became very provocative, theatrical, iconoclastic, disruptive. And then I finally listened to them. And when I did, it became clear that they were making perfect sense. And if I were in their shoes, I would have been doing exactly what they were doing. So, it's a very interesting part of our history, the very positive role of the activist community. In getting HIV drugs out sooner and getting them out in a more efficient manner.
[00:25:35] John Marshall, MD: And I've always wondered why the cancer community hasn't been able to sort of create that same unified, not just a pink tent or a brown tent in my case, but a unified rainbow tent to go up and say, we need to change how we do this increase, you know, we're at 8, 9 percent at best on clinical trial accrual now accepting bad diseases and not really pushing. And yet, spending whole lots of money on health, you know, on both screening and on therapy. And it's always been a disconnect.
[00:26:04] But, let me shift gears a little bit because one of my favorite interviews I've ever heard of yours was on a Saturday morning driving around for Wait, Wait, Don't Tell Me. It was just the best thing ever. It's a great show, best show ever. And as you know, on that, they bring famous people like you on and they say, well, we're not going to ask you about viruses. In that case, they asked you about computer viruses. If my memory is correct. Well, I'm going to do the same thing and ask your advice to all of us. You know, what are the secrets to avoiding burnout? What are the secrets? What do you do? What are some of the things you would advise those of us behind you, if you will, to do a better job of taking care of ourselves? You know, we have a common friend who, you know, you played three on three basketball with. I know you're a basketball junkie, but what is sort of your, your advice to us on that
[00:26:53] Anthony Fauci, MD: Yeah, I think it has, you have to have an outside, source of, of support. I was very fortunate in my wife, at the time, was a nurse, who was specialized in the clinical care of persons with HIV. She currently is the chair of the Department of Bioethics at NIH, and she actually is a Hoya all the way down. She went to undergraduate nursing school. She got her PhD at the Kennedy Institute of Ethics with Ed Pellegrino.
[00:27:31] She was very, very helpful in grounding me when I would come home after losing two or three people, mostly, as I mentioned, young, otherwise previously healthy, gay men to just get me to realize to focus on the potential good that you can do and not the disappointments. Because if you focus on the fact that you didn't succeed, even though you tried, you can really get very discouraged. So, what you got to do is focus on the positive nature of the effort that you put in, hoping that someday that effort is going to result in something that's much, much, much more favorable. And that's exactly what happened because years later, what went from everyone dying to essentially people leading normal lives on medication. So, support structures are incredibly important. Yeah.
[00:28:36] John Marshall, MD: so disappointed that you didn't list bourbon as one of the options, but apparently that should be lower on my list. And famously, it is 1 of my vehicles, but never, never before 6, but let's make this be clear. But anyway, so. I hear you loud and clear. And I think it's great advice for all of us. Not the bourbon, by the way, you out there listening. That's not good advice. Let's close, you know, you've as you mentioned, and you reflected in your book this incredible duration of advice, you know, the folks that you have provided insights to in our leadership of our country. And one of the areas of focus on our series right now. Is what's called the inflation reduction act, lots of us are not really aware of it, but why it's coming to a head in oncology is in fact, they're starting to talk about negotiating drug price. And so, I'm actually taking our audience back to the beginning when Bush II signed into law. The revised Medicare support bill you know, no importing of drugs and no negotiation of drug price because more and more oral agents were needed, and Medicare didn't cover oral agents. So, we needed a vehicle to do that to now Biden's institution of the Inflation Reduction Act. To now a new administration that might wipe that away. And I realize you, you don't know everything and can't see the future, but I'm just wondering what you're thinking is about what we should look forward to what ahead to in terms of health care policy and changes
[00:30:08] Anthony Fauci, MD: Well, John, that is the big unknown question right now that's causing a lot of anxiety in the medical community. For my colleagues at the NIH, for my colleagues at the CDC, at the FDA, is that, will there be a dissolution of things that were very helpful to us, and will there be new things that are put into the hopper that might impede what our ultimate common goals are. And the answer is we don't know. And that's the reason why we're in a state of somewhat heightened anxiety because of not really knowing what exactly is going to happen. So my only advice would be to, you know, think positively that the better angels will prevail and that we'll have things that are sensitive, you know, to the needs of our patients and to the things that we're responsible for doing.
[00:31:06] John Marshall, MD: But bourbon wasn't on the list for that one either. But I understand completely. Why not? We're all talking to those angels right now to make sure that what we can do and what the progress we have can continue in the years to come.
[00:31:20] I've kept you long enough. I could keep you all day. Dr Anthony Fauci, who is really a world's leader in healthcare and global health. think of the number of people out th`1 ere in the world that he has saved. He wouldn't take credit for that personally, but we should give it to him. So, Dr Fauci, thank you very much for joining us.
[00:31:37] Thank you, John. It's a pleasure being with you. Appreciate it.
[00:31:40] Amazing to talk to Dr Anthony Fauci on his own personal experience, the impact that he's had as an individual on so many around us, but also his own reflection on his own health and his own well-being and some advice to us all. So, I hope you enjoyed our talk with Dr Anthony Fauci and will join us again on Oncology Unscripted.
Oncology Unscripted With John Marshall: Episode 10: Is the Inflation Reduction Act a Threat or Opportunity for Oncology?
Is the Inflation Reduction Act a Threat or Opportunity for Oncology?
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[00:00:05] John Marshall, MD: Hey everybody, John Marshall live from Washington DC where all the action is happening. A lot of moving vans are likely to be coming here soon as the new party comes in to take over maybe everything. We're going to have to see how that goes. We're all living in this crazy state of uncertainty about just how much. Are they saying is going to happen? But we'll see. That's our future.
[00:00:34] But what I really want to talk about on this episode of Oncology Unscripted is the beginnings of a discussion around health policy in oncology and the reason I'm bringing this up is I just recently came across my radar, something called the Inflation Reduction Act. Well, sure, I knew about the Inflation Reduction Act, but I didn't know how that was going to affect cancer. And then I started to think about, yeah, I do. They're going to negotiate drug pricing on cancer. And there's been this big turmoil about we can't do that. It'll break the system. We need the fixed drug pricing, et cetera, and I want to talk about that because it's starting to be put into place, and it might actually get wiped off the map in a couple of months, but maybe it won't. And I wanted to talk about it because it will affect what I do for a living, and that's to try and develop new drugs for cancer.
[00:01:29] But in order to do that, let's start by at the beginning of when the whole thing needed to be created in the first place. And that is go back to 2003 Bush II, Bush II to put into place a health modernization Medicare Modernization Act, which at the time was praised. Now, remember where we were people with Medicare didn't really have drug benefits. You went and paid cash at the pharmacy. But drugs were getting more and more expensive. And so, seniors weren't able to afford the drugs. And so, we needed to figure out how US health care was going to cover those drugs. And this was the deal that was cut now out of that deal. So, seniors got access to drugs. But for the tradeoff that always happens here in Washington, D.C. Now, the first one was that there was an agreement that we would not import new drugs from other countries. So, in other words, you couldn't manufacture it in Canada and then ship it across the border at Canadian prices. We weren't going to allow that. So, the borders were closed to import so that we could save the price structure here in the United States. And with that rule came another corollary is that we could not negotiate drug pricing with the manufacturer. Whatever they said was going to cost, that's what CMS would pay. And as a result, that was when we could no longer judge value as a nation. So, if you can't connect magnitude of benefit, which is what the FDA judges, did it work or not, to the cost, that's what CMS has to do, you can't judge value. Right? There's no way. Okay, it'll cost $100,000. Okay, but what do I get for that? Well, it could only be 6 weeks. And that would be enough for it to get FDA approval. And Medicare would have to pay. the third component was something called 340B pricing, and that is institutions like mine and many of the institutions around the United States pay a reduced amount for the product, get paid by insurance companies, the delta, and with that extra money that we get as a healthcare institution, we're supposed to provide All those other things that cancer care delivers. A nutritionist, a social worker, nursing support, et cetera, that don't have any billing infrastructure for it.
[00:04:08] And so that non negotiated price, the rising cost of cancer drugs, and this 340 B pricing is our current economy. And with that, all of our industries more or less dependent on that pricing structure. So, the inflation reduction act is a threat to that, right? Because if we're going to start picking and choosing drugs that can be negotiated on price, then how does that affect the revenue stream?
[00:04:37] And how does that affect the reimbursement into research? And so, our whole series on the next few episodes is going to be focused on the Inflation Reduction Act and what it does now, and what it could do in the future. And why we're worried about it. We hope to get some good folks who are in the middle of this discussion to talk to us about it. It's a fairly sensitive subject. So, we are hoping for that. So, stay tuned to future episodes.
Cancer Care in America: Equal Access or Uneven Outcomes?
[00:05:05] But as part of this episode, I wanted to talk about yes, U.S. health care, but I wanted to talk about. Does everyone get the same U.S. healthcare? Now, the reason this has become important to me is that we just did a study here in Washington, D.C. between two of our main hospitals that I work in. They service very different patient bases and neighborhoods. They're both busy cancer hospitals. They both provide specialized cancer care. That's important. But one, quote unquote, has a lot of issues with social determinants of health. Barriers to access to cancer care, because as we've talked about, cancer care is complicated to receive, it's complicated to give, and if both parties are doing okay, then it's okay, but if one is challenged, then it's not okay, right?
[00:05:54] So what we did is a big study of a thousand patients with colon cancer, and actually extracted from their charts, 400 from one hospital, 600 from another, and believe it or not, We were expecting to see a difference in outcomes that the social determinants of health were in fact going to affect the outcomes for those patients. But not only did we see no difference, we saw that. In fact, our record here in our health care system was better than published national averages. Molecular profiling, time to treatment, survival, all the key points we want. And after an initial sense of pride, I'm like, well, wait a second. That is not what we were expecting, right? We were expecting there to be a difference because of the populations that we were serving was different.
[00:06:42] And so we then developed a new theory, which we are testing now, that can a general oncologist, nobody out there get offended, keep up. With everything that needs to be kept up with in every disease, and I think if you ask most general oncologists, they would say they do a very good job, which I would agree with, but maybe not as good as it could be. On the other hand, what if you live in a remote part of the world in our country? How far do you have to go to even find a cancer doctor or a place where you can get an infusion? So, we have this issue of general oncologists and remote access, right?
Bridging the Distance: Can Rural America Get Equal Access to Cancer Care?
[00:07:23] And so there have been a couple of, you know, announcements lately about new projects. There was 1 that looks like it was funded by ASCO and it's in rural Montana where they're going to use a hub and spoke model where there's going to be infusion sites around in the. and then they'll be in a remote country, but then there'll be centralized care. It's exactly how Canada does it now, all the doctors live along the southern border of Canada, right? Because that's the only place where there's not snow all the time. And they've talked to, using telemedicine, patients who live up further away. And then there are local nurses and general doctors who administer the cancer care. So that hub and spoke model we know works in the Canadian health care system.
[00:08:08] , There was recently Iowa, as you might imagine, great centralized cancer care, but how do they care for folks out and around? So, the University of Iowa bonded with Mission Cancer and Blood, 280 million dollars changed hands, but to basically deliver cancer care in a remote areas. Now this is great. This is what we need for our people and for everyone around our country is good access to cancer care.
[00:08:37] But what our little study may be hinting at is maybe this also needs to be done by cancer specialists. Should we begin to divide even general practice knowledge into its subcategories because it's gotten so complicated? The analogy I like to use is if I had a bunch of okay. And the answer is no, I can be an expert in one or two, but I can't know all the nuances of all the different board games. So we're going to have to figure out not only provide cancer care for everybody, but Through these kinds of networks, hub and spoke model, but how do we make sure that we're actually delivering the highest level of cancer care that we can so that our patients can get the best outcomes and the best and the right therapies on time, et cetera.
Is the U.S. Health System Designed to Fail Its Patients?
[00:09:30] So the last point I want to make about all of this health care policy. It really comes from a recent survey paper that looked at the different health care systems and outcomes around the world. And we always think, because we're the United States of America, that we have the best of everything. Well, we do have the best hamburgers that I'm going to give us. Maybe the best fried chicken, too. I would say that's probably true. Best bourbon? Yeah, I think we have that. But in terms of the best care and healthcare, when you look at the top, like richest countries, we don't. We're in fact, of the top ten, guess what number we are? We're the worst in terms of access to care. Bad health outcomes. Bad worse. So, 9th administrative efficiency. I didn't need to tell you that. Equity, we're 9th in that where we are. The best is what they call care process. So if you're in the system, we got all the bells and whistles, but we leave lots and lots of people behind.
[00:10:40] And so, as we think about going forward, we have the inflation reduction act, which is trying to make cancer care more accessible and more affordable for our patients. We've got administrative and economic pushback on that. We have a new administration that, who knows what they're going to blow up going forward. But we know for sure. One of their priorities is not equal access to everybody around our country.
[00:11:04] So as we spend the next couple of months reflecting on where we've been and where we're going, fingers crossed, that reason will prevail, that we will prioritize the patients in general. That access does matter that we want to level the playing field to health care as much as we can for all of our patients across our great nation. And I think with that, we will show how we can work together and how we can bridge our divides as we walk forward over the next 4 years. John Marshall for Oncology Unscripted.
Pandemics, Presidents, and Perseverance: A Candid Conversation with Dr Anthony Fauci
You know, I've interviewed a lot of people in my career, but I don't think I've ever had quite the joy of interviewing someone who, honestly, I think almost everybody in this country, there's some who don't feel this way, but, almost everybody, in this country who think is a real modern day hero, and this is Dr Anthony Fauci, and he has agreed to join us and talk about a few subjects that sort of near and dear to maybe both of our hearts and share them with us all. And on a second note, I want to welcome him as he's flying the Georgetown University flag behind him. I've been here on the faculty for 31 years and I'm not sure I've, I don't want to insult any of my other colleagues, but I'm not sure I've ever had quite so, such an esteemed colleague from my own university, join me. So, Dr Fauci, first, thank you very, very much for joining us today. And let me give my own personal Hoya Saxa welcome to Georgetown University.
[00:12:35] Anthony Fauci, MD: Thank you so much, John. Pleasure to be with you.
[00:12:38] John Marshall, MD: Well, you're awfully nice. Part of what has sparked my interest in talking with you just beyond all that you've been through and all that you've led us through over the years, is really some subjects that came forward in your book. It was really an impactful book. If you haven't gotten it yet, gang out there, it's called On Call. It’s a terrific book available on audio as well for those of you who like to walk and listen at the same time. It's really an extensive review of your own life and the impact that you've had in your own reflections on very, very dramatic moments in medical history. And I wonder if you just start by kind of sharing the sort of inspiration to write it and sort of the emotion and what it took to stop and get all of that down.
[00:13:25] Anthony Fauci, MD: Yeah, well, thanks, John. I decided to write the book because when I came to what I was projecting to be the end of a 54 year career at the NIH, Almost 40 years of which was as the director of the NIAID, which positioned me to essentially be in the eye of the hurricane in the evolution of, as you mentioned, the most impactful pandemics in modern history HIV in the early 80s and through the next 40 years, and then followed by COVID-19.
[00:13:57] That started, at least in the United States, we had the impact of it in the early months of 2020. When I decided I was going to step down, I thought it would be important, given I had the unique experience of this, journey through these two major pandemics, but also in between advising seven presidents of the United States from Ronald Reagan through the Bushes, through Clinton, through Obama, through Trump, and then finally the seventh. when I spent two years as the Chief Medical Advisor to Joe Biden. I thought that that was such a unique experience. My thoughts were two-fold. One, I thought from a historical standpoint, I thought it might be useful for people to see what that was like to go through the early years of the pandemic with HIV and then throughout COVID, but also hopefully to serve as an inspiration for younger individuals who might have an inkling they might want to go into science or medicine or public health. And my description of the early years I believe were important because right now with HIV, we have a single pill with three antiretrovirals that can put a person into complete remission by bringing the level of virus to below detectable and keep it there, essentially indefinitely.
[00:15:27] But I hearken back in the book, in the memoir, to those early years from 1981 through the mid-80s, the late 80s. And the early 90s, when we did not have adequate therapy, and I found myself as a physician who, prior to HIV/AIDS, was rather successful in developing remission inducing therapeutic protocols for auto inflammatory disease, where most of my patients who thought they were going to die actually went into remission, then entering the arena of caring for and studying persons with HIV. I describe it in the memoir as the dark years of my medical career and the stress and the strain. Of seeing virtually all your patients, mostly young, otherwise previously healthy gay men who are dying terrible deaths, no matter what you did. And it was like putting bandages on hemorrhages. You know, I described in the book, I still to this day have flashbacks of what I call a version of post-traumatic stress. Because. When you were taking care of these people early on in the early 80s, you could not get emotionally involved in it because you had too much work to do, and your job was to take care of the patients. So, you suppressed it. It only was years later when you reflect on what you've been through that you understand that you didn't have time to burn out because you had too many people to that you had to take care of. But it was an extraordinary experience, which was an important part of the book to describe those early years of HIV.
[00:17:17] John Marshall, MD: Yeah, well, and taking care of yourself was had to be last on the list because everybody else needed you and there were no, you know, it was sleep, eat and take care of people. I remember in 1988 when I became an intern here at Georgetown walking the halls and those floors still exist. There’s new tile, but the floor still exists. And, you know, I remember the faces of the young men that you describe in there and being the guy who had to go in the gown and get the blood because we didn't have phlebotomists back then and being afraid actually to have a needle in my hand and have an HIV patient that I needed to get blood on or to put a line in or something like that, but at the same time they were alone and you wanted to be there with them because the way the rules were in hospitals as they frequently couldn't have visitors and certainly that was traumatic for me and I, like you say, I probably tucked that away. Then I decided to take on the easy task of trying to cure GI cancers. Not done nearly as well as you've done with viruses
[00:18:16] My experience was then my wife gets breast cancer. And I thought she was going to die. And now all of a sudden I knew what it felt like to be a caregiver or to be a patient. when in fact, I had probably tucked that away for many, many years. and when it, then I tried to, back to we're busy and we got to cure people, deliver that care for every cancer patient that was here. I realized there was no way that you can deliver that level of cancer care, the cancer care that we received as patient and caregiver. I couldn't turn around and give that to everybody who walked in the door. And that was in essence my source of burnout because I was feeling the impact. I was feeling the shortcomings, and actually had to get away for a while. And, and part of our book reflects on that. I think the young people today, and I would love to hear your sort of comparison because I experienced both, you experienced both pandemics, but a lot of our gang around here, you know, they cut their teeth on a pandemic. The interns and residents were on call, and you know, burning their clothes at their door on the way home in that same sort of way we felt with HIV.
[00:19:22] Do you have a sense of how they might be different or how they were different for you, the two experiences?
[00:19:28] Anthony Fauci, MD: Well, yeah, they were different for me, John, for the following reasons, that through the early years of HIV, even after I became Director of the Institute, I was very actively involved in the individual care of individuals, which led to that very stressful, emotional experience that I mentioned to you a moment ago. When it came to COVID, for me personally, it was a different experience because I was in a position of public health influence where I was, you know, as part of the coronavirus task force in the White House, making decisions that were difficult because we had an evolving outbreak that was not just selectively impacting a subpopulation, it was global that everyone was at risk. So, we had a true global health and domestic health catastrophe with COVID, and we had to, to the best of our capability, make decisions about what public health recommendations would be that would involve everyone, not just a small subset of people.
[00:20:45] At the same time I had the responsibility, together with the pharmaceutical companies, to develop the vaccine. And I could say that was one of the things that we're very proud of, is that my group at NIAID, the Vaccine Research Center that I established 20 plus years ago, was the group and the organization that developed the vaccine the highly immunogenic immunogen that partnered with the mRNA platform to create a vaccine in 11 months, which as you well know, that is a fraction of the normal time it takes to develop a safe and effective vaccine, which usually averages, 7 to 10 years. So, a combination of major investments on the part of the government, the scientific input from my group, and the incredible work that the pharmaceutical companies did. We had a vaccine in 11 months. So that was very, very different from the multiple years it took before we could get a drug for HIV. Remember the first patient that I admitted, with HIV, was in 1981. The first drug that had any effect on HIV was 1987, and it wasn't until 1996 that the triple combination of drugs were made available, which actually dramatically diminished the viral capability and viral load.
[00:22:18] John Marshall, MD: I used to say back in the day that the only reason the HIV success happened was that gay men, essentially, became very powerful self-advocates, and demanded this when there was probably a public sentiment that you were up against even then to do this.
[00:22:34] With the pandemic, even though you did have global support. You did also have to climb a hill over some who thought this was all some sort of conspiracy. We all know that, but so we are grateful for that. But it does require that sort of will to do it. But to your point, if the will's there and the science is ready for it, it can be done. And so to reflect on that, you coaching me as an oncologist, do you think that if the will were there and we spent the money that we are spending every year on cancer care and cancer medicine, if we spent it more wisely, could we in fact have better outcomes than we do now? What's your thought on that?
[00:23:15] Anthony Fauci, MD: I think so. I mean, if you look at the focus concentrated effort that was put into drug development for HIV, it is one of the greatest success stories of modern medicine. I mean, where all of your patients are dying from an infection that you just could not treat at all to years later when you have a single pill that can essentially drop the level of virus to below detectable and keep it there, not only saving the life of the person, but making it impossible for that person to transmit the virus to someone else.
[00:23:51] John Marshall, MD: at the time, we had like 90 percent accrual rate on clinical, everybody was on a trial, right? It was uncool. Not to be on a trial.
[00:23:59] Anthony Fauci, MD: Yeah, that's exactly what it was. I mean, and you know, you mentioned a moment ago, John, the importance of the AIDS activists in getting community involvement in everything from the design of clinical trials to make it more user friendly to them, to challenging the rigidity of the regulatory process to get drugs approved. Because the FDA process prior to AIDS was very well accepted. It provided safety for the American public, and it got drugs out. But it was ill suited to the emergent nature of HIV, where when someone had clinical disease, it was 12 to 15 months before they died, and interventions before they got through the FDA process would take six years, seven years. It just didn't work for them. So, they pushed back, and the scientific community and the regulatory community didn't listen to them. So, they became very provocative, theatrical, iconoclastic, disruptive. And then I finally listened to them. And when I did, it became clear that they were making perfect sense. And if I were in their shoes, I would have been doing exactly what they were doing. So, it's a very interesting part of our history, the very positive role of the activist community. In getting HIV drugs out sooner and getting them out in a more efficient manner.
[00:25:35] John Marshall, MD: And I've always wondered why the cancer community hasn't been able to sort of create that same unified, not just a pink tent or a brown tent in my case, but a unified rainbow tent to go up and say, we need to change how we do this increase, you know, we're at 8, 9 percent at best on clinical trial accrual now accepting bad diseases and not really pushing. And yet, spending whole lots of money on health, you know, on both screening and on therapy. And it's always been a disconnect.
[00:26:04] But, let me shift gears a little bit because one of my favorite interviews I've ever heard of yours was on a Saturday morning driving around for Wait, Wait, Don't Tell Me. It was just the best thing ever. It's a great show, best show ever. And as you know, on that, they bring famous people like you on and they say, well, we're not going to ask you about viruses. In that case, they asked you about computer viruses. If my memory is correct. Well, I'm going to do the same thing and ask your advice to all of us. You know, what are the secrets to avoiding burnout? What are the secrets? What do you do? What are some of the things you would advise those of us behind you, if you will, to do a better job of taking care of ourselves? You know, we have a common friend who, you know, you played three on three basketball with. I know you're a basketball junkie, but what is sort of your, your advice to us on that
[00:26:53] Anthony Fauci, MD: Yeah, I think it has, you have to have an outside, source of, of support. I was very fortunate in my wife, at the time, was a nurse, who was specialized in the clinical care of persons with HIV. She currently is the chair of the Department of Bioethics at NIH, and she actually is a Hoya all the way down. She went to undergraduate nursing school. She got her PhD at the Kennedy Institute of Ethics with Ed Pellegrino.
[00:27:31] She was very, very helpful in grounding me when I would come home after losing two or three people, mostly, as I mentioned, young, otherwise previously healthy, gay men to just get me to realize to focus on the potential good that you can do and not the disappointments. Because if you focus on the fact that you didn't succeed, even though you tried, you can really get very discouraged. So, what you got to do is focus on the positive nature of the effort that you put in, hoping that someday that effort is going to result in something that's much, much, much more favorable. And that's exactly what happened because years later, what went from everyone dying to essentially people leading normal lives on medication. So, support structures are incredibly important. Yeah.
[00:28:36] John Marshall, MD: so disappointed that you didn't list bourbon as one of the options, but apparently that should be lower on my list. And famously, it is 1 of my vehicles, but never, never before 6, but let's make this be clear. But anyway, so. I hear you loud and clear. And I think it's great advice for all of us. Not the bourbon, by the way, you out there listening. That's not good advice. Let's close, you know, you've as you mentioned, and you reflected in your book this incredible duration of advice, you know, the folks that you have provided insights to in our leadership of our country. And one of the areas of focus on our series right now. Is what's called the inflation reduction act, lots of us are not really aware of it, but why it's coming to a head in oncology is in fact, they're starting to talk about negotiating drug price. And so, I'm actually taking our audience back to the beginning when Bush II signed into law. The revised Medicare support bill you know, no importing of drugs and no negotiation of drug price because more and more oral agents were needed, and Medicare didn't cover oral agents. So, we needed a vehicle to do that to now Biden's institution of the Inflation Reduction Act. To now a new administration that might wipe that away. And I realize you, you don't know everything and can't see the future, but I'm just wondering what you're thinking is about what we should look forward to what ahead to in terms of health care policy and changes
[00:30:08] Anthony Fauci, MD: Well, John, that is the big unknown question right now that's causing a lot of anxiety in the medical community. For my colleagues at the NIH, for my colleagues at the CDC, at the FDA, is that, will there be a dissolution of things that were very helpful to us, and will there be new things that are put into the hopper that might impede what our ultimate common goals are. And the answer is we don't know. And that's the reason why we're in a state of somewhat heightened anxiety because of not really knowing what exactly is going to happen. So my only advice would be to, you know, think positively that the better angels will prevail and that we'll have things that are sensitive, you know, to the needs of our patients and to the things that we're responsible for doing.
[00:31:06] John Marshall, MD: But bourbon wasn't on the list for that one either. But I understand completely. Why not? We're all talking to those angels right now to make sure that what we can do and what the progress we have can continue in the years to come.
[00:31:20] I've kept you long enough. I could keep you all day. Dr Anthony Fauci, who is really a world's leader in healthcare and global health. think of the number of people out th`1 ere in the world that he has saved. He wouldn't take credit for that personally, but we should give it to him. So, Dr Fauci, thank you very much for joining us.
[00:31:37] Thank you, John. It's a pleasure being with you. Appreciate it.
[00:31:40] Amazing to talk to Dr Anthony Fauci on his own personal experience, the impact that he's had as an individual on so many around us, but also his own reflection on his own health and his own well-being and some advice to us all. So, I hope you enjoyed our talk with Dr Anthony Fauci and will join us again on Oncology Unscripted.
This transcript has been lightly edited for clarity.