Podcast appearances and mentions of Clifford A Hudis

On Saturday, October 14, Dr. Marianne T. Ritchie spoke with Dr. Clifford A. Hudis about important information and how participation in a trial can be very beneficial.

In a panel moderated by Dr. Karen Knudsen, CEO of American Cancer Society, four leaders in oncology proposed an action plan for tackling cancer health disparities and creating health equity. The panel includes Clifford A. Hudis, CEO, American Society of Clinical Oncology; Executive vice chair, Conquer Cancer Foundation; Chair, CancerLinQ; Chanita Hughes Halbert, Vice chair for research, professor, Department of Population and Public Health Sciences; Associate director for cancer equity, Norris Comprehensive Cancer Center, University of Southern California; Amy E. Leader, Associate professor of population science and medical oncology, associate director of community integration, Sidney Kimmel Cancer Center; Public health teaching faculty, College of Population Health, Thomas Jefferson University; Cheryl Willman, Executive director, Mayo Clinic Cancer Programs (nationally and globally); Director, Mayo Clinic Comprehensive Cancer Center. A transcript of this panel is available here: https://cancerhistoryproject.com/article/experts-propose-action-plan-on-health-equity-panel/

A preview of the interview by ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis with retiring ASCO Chief Medical Officer Dr. Richard L. Schilsky examining Dr. Schilsky’s trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. Dr. Hudis also shares what Dr. Schilsky’s friendship and mentorship has meant to him and suggests that he will still be supporting ASCO on critical priorities. Find all nine of ASCO's podcasts and subscribe at podcast.asco.org. TRANSCRIPT Dr. Clifford Hudis: Hello, I’m Dr. Clifford Hudis, CEO of ASCO, dropping into your feed to let you know about a special episode of the ASCO in Action podcast featuring the extraordinary career of Dr. Richard Schilsky, ASCO’s Chief Medical Officer. Rich and I discuss the advances that have revolutionized cancer care over the last 50 years and much, much more. Here’s a preview of the episode. Dr. Richard Schilsky: The 1980s in many respects were the doldrums of progress in clinical oncology. There really was not a lot of innovation in the clinic. But what was happening and what was invisible to many of us, of course, was that was the decade of discovery of the fundamental biology of cancer. That's when oncogenes were discovered, when tumor suppressor genes were discovered, when it became clear that cancer was really a genetic disease. And that is what transformed the field and put us on the path to targeted therapy and precision medicine as we think of it today. Dr. Clifford Hudis: You can find the ASCO in Action Podcast on Apple Podcasts or wherever you are listening to this show. And you can find all nine of ASCO’s podcasts which cover a wide range of educational and scientific content and offer enriching insight of the world of cancer care at podcast.asco.org.

Retiring ASCO Chief Medical Officer Dr. Richard L Schilsky gives a far-reaching interview with ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis, who examines Dr. Schilsky’s trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. ASCO’s first-ever Chief Medical Officer even offers some friendly advice for Dr Julie Gralow, who starts as ASCO’s next CMO on February 15, 2021. In a touching tribute, Dr. Hudis also shares what Dr. Schilsky’s friendship and mentorship has meant to him personally, and suggests that Rich will still be supporting ASCO on critical priorities moving forward. Don’t miss this exchange with one of oncology’s greats! Transcript DISCLAIMER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. CLIFFORD HUDIS: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is a series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO and the host of the ASCO in Action podcast series. For today's podcast, I am especially pleased to have as my guest my friend, colleague, and mentor Dr. Richard Schilsky, ASCO's chief medical officer. Now, I am sure that many of our listeners have already heard that Dr. Schilsky will be leaving ASCO in February of 2021, retiring. However, I want to reassure everybody that even in retirement, he will continue to make contributions and provide leadership to all of us. And his illustrious and path-blazing career in oncology spanning more than four decades is not quite over thankfully. Rich is ASCO's first chief medical officer. And as such, he has made a truly indelible mark on all of us. He started with a proverbial blank piece of paper. The position had no precedent. It had no budget. It had no staff. But now after just eight years in the role, he has helped make the CMO a critically important position at the society. And I have to say that success is more than anything due to Rich's vision and his leadership. And that's some of what we'll be talking about today. So Rich, thank you very much for joining me today for what I hope is going to be a great casual but informative conversation about your amazing career, your unique role at ASCO, and maybe most importantly in the end what you see for the future of oncology not just in the United States, but around the world. Thanks for coming on, Rich. RICHARD SCHILSKY: Thanks, Cliff. It's great to be here today. CLIFFORD HUDIS: So with that, let's just dive right in and start at the very beginning. Rich, tell everybody why you decided to become an oncologist and maybe share a little bit about what those early days looked like for you and, in that context, what it was like to have cancer at the beginning of your career. RICHARD SCHILSKY: Well, I knew from an early age that I wanted to be a doctor. And in fact, I had written a little essay when I was in sixth grade as a homework assignment called My Ambition. And my mother had tucked that away in a scrapbook. And I found it a number of years ago. And on rereading it, it was quite amazing to me to see what I was thinking about even then. Because I said not only did I want to be a doctor, but I didn't think that was enough, that I wanted to be a medical researcher because I wanted to discover new information that would help people heal from whatever their diseases might be. And so it was never really any doubt in my mind that I would be a physician. I went to medical school at the University of Chicago. But I was living in New York City at the time having grown up in Manhattan. And the only year we had off in medical school, the only time we had off in medical school, was the summer between the end of the first year and the beginning of the second year. So during that time, I went back to Manhattan. And I was able to get a fellowship from the American College of Radiology that allowed me to essentially hang out in the radiation therapy department at New York University Medical Center, which was within walking distance of where I grew up. And so I would go over there every day. And I was taken under the wing of a young radiation oncologist. And of course, I wasn't really qualified to do anything at that point except to follow him around, talk and listen to the patients. But that turned out to be a really formative experience for me because we saw the whole gamut of cancer. We saw head and neck cancers. We saw lung cancer. We saw patients with breast cancer and prostate cancer. And in those years-- this is the early 1970s-- many of these patients have fairly locally far advanced disease and were quite debilitated by it. But listening to their stories, hearing about their hopes and their struggles, really demonstrated to me the human side of cancer. So I went back to school and thought about this in the context of my own personal experience, which dated back to when I was in college when my mother's mother, my maternal grandmother, was diagnosed with breast cancer. This was 1968. And as you well know, there were very few therapies available for breast cancer in the late 1960s, mostly hormone therapies. And my grandmother had the treatment that was considered standard of care at that time, which was extended radical mastectomy followed by chest wall radiation. And some years after that first mastectomy, she had a breast cancer that developed in the opposite breast and had a second extended radical mastectomy and chest wall radiation. And these were very traumatic and disfiguring procedures for her to go through. Anyway, long story short is after another few years, she developed bone metastases and then brain metastases. And there was really very little that could be done for her other than hormone therapies. And having observed her go through that illness and realizing how limited our treatment options were and then having the experience after my first year in medical school pretty well cemented for me that I wanted to be an oncologist. I thought actually about being a radiation oncologist. But then I did my internal medicine rotation in medical school, fell in love with internal medicine. And that sort of put me on the path to be a medical oncologist. The clinical challenge of caring for cancer patients, the emotional attachment to those patients, and, of course, even then, the unfolding biology of cancer was so intellectually captivating that I actually applied for oncology fellowship when I was a senior medical student. So even before going off to do my medical residency, I had already been accepted as a clinical associate at the National Cancer Institute to start two years hence. And that's how I became an oncologist. CLIFFORD HUDIS: So it's so interesting. Because, of course, the story I'm sure for many people interested not just in oncology, but even medical education, there are little things that don't happen nowadays that happened with you like that last little vignette about the early acceptance into an advanced training program before your fellowship among other things. Can you remind us about the timeline? Because I think one of the things that many of our listeners often can lose sight of is just how new oncology really is as a specialty. ASCO itself founded in 1964. And the first medical oncology boards were mid-'70s, right? So you were in med school just before that second landmark, right? RICHARD SCHILSKY: That's right. I graduated from medical school in 1975. I started my oncology fellowship in 1977. And I got board-certified in medical oncology and joined ASCO in 1980. And so that was the time frame at that point. CLIFFORD HUDIS: So the internal medicine was actually, if I heard you right, just two years, not the now traditional four. RICHARD SCHILSKY: Yeah. I was a short tracker. I did only two years of internal medicine training rather than three. I did my training at Parkland Hospital and University of Texas Southwestern in Dallas with at that time a legendary chair of medicine, Don Seldin, who I had to get permission from him to leave the program prior to completing the third year of residency because I had already been accepted into fellowship at NCI. And he, Seldin, who was a brilliant chairman and a brilliant nephrologist, was not at all interested in cancer. And it took a bit of-- I was going to say arm twisting, but it really took bleeding on my part to get him to agree to allow me to leave the residency program to go to the NCI. But he eventually agreed. And in those years, the first-year clinical fellowship at the NCI was like being an intern all over again. There were about 15 of us. We were on call overnight in the clinical center once every two weeks. We cared for all of our inpatients as well as had a cadre of outpatients. We did all of our own procedures. We had no intensive care unit. So patients who were sick enough to require ventilator support, we cared on the floor in the inpatient service on our own with guidance from senior oncologists. It was a bit different from the way it is now. But, of course, it was fantastic on-the-job training because we just learned a ton and had to learn it very quickly. CLIFFORD HUDIS: So that's actually a great segue to the advances because there was a lot to learn then. But, wow, there's a lot more to learn, I think, now. And I have real sympathy for trainees and younger oncologists for the breadth of what they need to learn. Again, just testing your memory, but platinum came along pretty much in the mid-'70s as well, right? That was a pivotal expansion of the armamentarium for us. So what do you see-- when you summarize progress in cancer research and care over these decades, what do you think are the most pivotal or revolutionary milestones that you identify over the span of your career? RICHARD SCHILSKY: Yeah. It's really interesting to think about it historically. There were the early years of discovery in oncology from the 1950s to the 1970s when we really had the introduction of the first chemotherapy drugs and the miraculous observation that people with advanced cancer could actually obtain a remission and, in some cases, a complete remission with chemotherapy and combination chemotherapy in particular. And so that was the formative years of oncology as a medical specialty and really proof of concept that cancer could be controlled with drugs. When we got into the 1980s, the 1980s in many respects were the doldrums of progress in clinical oncology. There really was not a lot of innovation in the clinic. But what was happening and what was invisible to many of us, of course, was that was the decade of discovery of the fundamental biology of cancer. That's when oncogenes were discovered, when tumor suppressor genes were discovered, when it became clear that cancer was really a genetic disease. And that is what transformed the field and put us on the path to targeted therapy and precision medicine as we think of it today. So I think that clearly understanding the biology of cancer as we do now and all that it took to lead us to that point, which was a combination of understanding biology, developing appropriate technology that would, for example, enable the sequencing of the human genome and then the cancer genome. And the other formative technology in my opinion that really changed the way we care for cancer patients was the introduction of CT scanning. When I was still a fellow at the NCI, we did not have a CT scanner. If we needed to get detailed imaging of a patient, we did tomography. And if you remember what tomograms looked like, they were really blurry images that you could get some depth perception about what was going on in the patient's chest or abdomen. But they really weren't very precise. When CT scanning came along, it really revolutionized our ability to evaluate patients, assess the extent of disease, stage them in a much more precise way, which then allowed for better patient selection for curative surgery, better radiation therapy planning. So we don't often point to imaging advances as some of the transformative things that paved the way in oncology, but I think imaging is really overlooked to some extent. So I think the technology advances, the biological advances, are the things that really allowed the field to move forward very quickly. And by the time we got into the mid-1990s, we were beginning to see the introduction of the targeted therapies that have now become commonplace today. And then it was around 2000, I think, that we saw the introduction of Gleevec. And I'm reminded always about an editorial written by Dan Longo in The New England Journal a few years ago. And Dan and I were fellows together. We worked side by side on the wards at the clinical center and became very good friends. And Dan in his role as a deputy editor of The New England Journal wrote an editorial a few years ago that was titled "Gleevec Changed Everything." And Gleevec did change everything. It changed our entire perception of what were the drivers of cancer and how we might be able to control cancer very effectively and potentially put it into long-term remission. Now, of course, we know now that the whole Gleevec story is more of an exception than a rule in targeted therapy. And, of course, we know that tumors become resistant to targeted therapies. But we couldn't have known any of this back in the early years of oncology because we had no real insight into what caused cancer to grow or progress. And the notion of drug resistance, while we realized that it occurred, we had no idea what the mechanisms were. So it's such a different landscape now than what it used to be. It's quite remarkable. CLIFFORD HUDIS: So as you tell the story, there's, of course, a lot of focus on technology, whether it's biology and understanding the key features of malignancy or imaging or more. But what I also note in your story and I want to come back to is the people. And I can't help but reflect on where we are in this moment of the COVID-19 pandemic. Yes, we've moved to telemedicine. Everything can be accomplished via technology. And, yet, the human touch is so important. When we think about being in the room with people, when we think about face to face from the context of career development and your own career, you touched on Dr. Seldin, I think, already from the perspective of internal medicine training. But are there are other mentors or important shapers of your career that you think we should know about? RICHARD SCHILSKY: Well, probably, the most influential person early in my career in medical school was John Altman. John, you may know, was the inaugural director of the University of Chicago's NCI-designated Cancer Center, which was one of the very first NCI-designated cancer centers in 1973 after the National Cancer Act of 1971 created the cancer centers program. And John, who was a leading oncologist studying Hodgkin and non-Hodgkin's lymphoma, was a faculty member there. He was the director of our cancer center as I said. He took me under his wing even when I was in medical school and served as a real role model and mentor to me. When I was in my internal medicine training as I mentioned earlier, Don Seldin, the chair of medicine, was never particularly interested in oncology. So, to some extent, I didn't have-- I had great internal medicine training. But I did not have good mentorship in oncology. When I got to the NCI, then my whole world really opened up. And the two pivotal people there in my career were Bob Young, who was chief of the medicine branch and was my clinical mentor and remains a mentor and friend to this day, and then, of course, Bruce Chabner, who was the chief of the clinical pharmacology branch. And in my second year of fellowship when we all went into the laboratory, I went into Bruce's lab. And that's where I really got interested in the mechanism of action of anti-cancer drugs and ultimately in drug development and early phase clinical trials. And both Bob and Bruce remain very close to me even today. CLIFFORD HUDIS: So I'm concerned about time on our call today on our discussion. Because we could obviously fill lots of hours on all of these remarkable experiences and amazing people you worked with. But I'm going to ask that we fast forward a little bit. You and I share, I think, passion and love for ASCO. So I think that it's reasonable for us to focus a little bit on that for the time we have left here. You didn't start out obviously as chief medical officer at ASCO. But you were a really active ASCO volunteer and leader. Maybe tell us a little bit about some of the ASCO volunteer roles that you engaged in and what that meant to you at the time and how that led to this role. RICHARD SCHILSKY: Well, I'll be brief. I joined ASCO in 1980 at the first moment that I was eligible to join ASCO. I had attended my first ASCO meeting the year before, 1979, when I was still in my fellowship training. And it was clear to me even then when the whole annual meeting was about 2,500 people in two ballrooms in a hotel in New Orleans that that was a community of scholars and physicians that I wanted to be a part of. And so, over the years, I did what people do even today. I volunteered to participate in whatever ASCO activity I could get involved with. Over the years-- I think I counted it up not too long ago-- I think I served or chaired 10 different ASCO committees, more often serving as a member, but in a number of those committees also serving as the chair over many years. And as I became more deeply involved in ASCO and saw other opportunities to engage, I had the opportunity to run for election to the board and was-- after a couple of tries was elected to serve on the board and then eventually elected to serve as ASCO president in 2008-2009. But the attraction of ASCO in many ways was a community of diverse but, in many ways, like-minded people, people who had similar passion and drive and focus. But I think what you get at ASCO in many ways is the wonderful diversity of our field. If you work in a single institution for much of your career as I did and as you did, you get to know that institution pretty well. You get to know its perspectives and its biases and its strengths and its weaknesses. But there's a whole world of oncology out there. And you can get exposed to that at ASCO because you meet and work with colleagues from every clinical setting, every research setting, people who have remarkable skills and interests and passions. And it's just a wonderful environment to help develop your career. So I consider myself to be extremely fortunate to have had the journey in ASCO that I've had culminating, of course, with ultimately my coming on the staff as ASCO's first chief medical officer. CLIFFORD HUDIS: We often joke about that blank sheet of paper. But in retrospect, it's very obvious that you had built up that collection of LEGO blocks, and then you assembled them all into the ASCO Research Enterprise, a name you gave it. And it really, in retrospect, builds, I think, very cleanly upon all of your prior experience, but also the vision that you developed based on that experience for how research should be conducted. Can you maybe share with everybody the scope and vision for the ASCO Research Enterprise, what the intent was, and where you see it going, and what it includes today? RICHARD SCHILSKY: Sure. I won't claim that I came to ASCO with the whole thing fully developed in my mind. As you said, when I came, I literally did have a blank slate. Allen Lichter, who hired me, said, come on board and help me make ASCO better. And so I, in a sense, reverted to what I knew best how to do, which was clinical research. And having in my career been a cancer center director, a hem-onc division chief, a cooperative group chair, I had a lot of experience to draw on. And it was obvious to me that ASCO was fundamentally an organization that took in information from various sources, evaluated it, vetted it, collated it, and then disseminated it through our various channels, most notably our meetings and our journals. But ASCO itself did not contribute to the research enterprise. And that seemed to me to be a lost opportunity. We knew that ASCO had lots of data assets that could be of interest to our members and to the broader cancer community. But they were scattered all around the organization and not particularly well annotated or organized. So we began to collate those. And they are now available to ASCO members on the ASCO data library. I recognized that we did not have an organized unit in ASCO to support or facilitate or conduct research. So, in 2017, we formed the Center for Research and Analytics and brought together staff who were already working at ASCO but scattered in different departments but all people who had an interest in clinical research or research policy and brought them into this new unit, which has really become the focal point for research work at ASCO. We recognized that ASCO members for many years were interested in surveying their colleagues, surveying other ASCO members, to help advance research questions. But ASCO actually had a policy that prohibited that. So that never really made good sense to me. It seemed like a lost opportunity. And we were able to create a program and have the ASCO board approve it whereby any ASCO member could opt in to participate in what we now call the Research Survey Pool. And in doing so, they are essentially agreeing to participate in research surveys conducted by their colleagues. So that program is now up and running. There are, I think, eight surveys that have been completed or are currently in the field. And this is now a service that ASCO provides through CENTRA to its members to enable them to survey their colleagues for research purposes. Most importantly, I think we saw an opportunity back in 2014 or 2015 to begin to learn from what our colleagues were doing in clinical practice as they began to deploy precision medicine. And there was a lot of genomic profiling that was going on at that time. It was revealing actionable alterations in roughly 30% or so of the tumors that were profiled. But there was a lot of difficulty in doctors and patients obtaining the drugs that were thought to be appropriate to treat the cancer at that particular time because most of those drugs would have to be prescribed off label. And there was not a sufficient evidence base to get them reimbursed. And, moreover, even if they could be reimbursed, there was no organized way to collect the patient outcomes and learn from their experiences. So that led to us developing ASCO's first prospective clinical trial, TAPUR, which really solves both of those problems. Through the participation of the eight pharmaceutical companies that are engaged with us in the study, we are providing-- at one point, it was up to 19 different treatments free of charge to patients. These are all marketed drugs but used outside of their FDA-approved indications. And we were collecting data on the patients, the genomic profile of cancer, the treatment they received, and their outcomes in a highly organized way. And so now this is a study that we launched in 2016. We're now almost to 2021. We have more than 3,000 patients who have been registered on the study, meaning consented to participate, more than 2,000 who have been treated on the study. And we are churning out results as quickly as we can about which drugs are used or not useful in the off-label setting for patients whose tumors have a specific genomic profile. So we built all this infrastructure. And having this in place has also then allowed us to respond rapidly to unmet needs. So when the COVID-19 pandemic overwhelmed all of us, and when our members were looking for information about what was the impact of COVID-19 on their patients, one of the things we were able to do because we had CENTRA, because we had a skilled staff and an infrastructure, was to very quickly stand up the ASCO COVID-19 registry, which we launched in April of this year. And there are now about 1,000 patients who've enrolled in the registry from around 60 practices that are participating. And we will follow these patients now longitudinally and learn from their experiences what has been the impact of the COVID-19 illness on them and their outcomes, how has it disrupted their cancer care, and ultimately how that impacts their overall cancer treatment outcomes. So as I now contemplate leaving ASCO after eight years having started with a blank slate, I'm very proud of the fact that I think I'm leaving us with a remarkable infrastructure. We now have a clinical trials network of 124 sites around the country participating in TAPUR that we never had before. We have through the work of CancerLinQ a real-world evidence data generator that is beginning to churn out valuable insights. We have a capacity to survey ASCO members for research purposes. We have an ability to stand up prospective observational registries to gather information longitudinally about patients and their outcomes. We have a core facility in CENTRA with highly skilled data analysts and statisticians that can support these various research activities. So ASCO is now primed, I think, to really contribute in a very meaningful way to the gaps in knowledge that will forever exist in oncology just because of the complexity of all the diseases we call cancer. And that's what I mean by the ASCO Research Enterprise. It is in fact remarkable and, I think, powerful enterprise if we continue to use it effectively. CLIFFORD HUDIS: Well, that's an interesting segue to my next thought, which is really about what comes next. I'll talk about you. But let's start with ASCO first. Your successor, Dr. Julie Gralow, obviously has been announced publicly. She's an accomplished clinician and researcher. She has a known recognized passion for patients, patient advocacy, clinical research through her leadership at SWOG but also health care equity and global oncology. So from your perspective, having created all of these assets and resources, what advice would you give Dr. Gralow publicly on how to make the position hers, what to take us to next? And I do want to acknowledge for everybody listening that the hints I've been making up until now are that Rich has agreed that he will continue to contribute as a leader to TAPUR for the short term, at least, at least the next year helping Julie get fully oriented to this program and others. So what will your advice be to Julie? RICHARD SCHILSKY: That's a great question. She's a great selection. And congratulations on hiring her. I think there are two key issues, I think, maybe three. One is to have a broad scope and cast a wide net. Oncology care and cancer research and cancer biology are incredibly complicated and nuanced and broad in scope. And although Julie is an accomplished breast cancer clinician and researcher, in this role at ASCO, you have to be very broad. You have to understand all of cancer care, all of cancer research, all of policy and advocacy not as an expert in necessarily in any one aspect of ASCO's work, but you have to understand the impact of all of those things on cancer care providers and on cancer patients. And it's important to always be looking to the future. The future is going to be here before you know it. And we as a professional society have to prepare our members for that future. So that leads me to the second point, which is listen to the members. The members are the people on the front lines who are delivering care to patients every day. And, fundamentally, ASCO's job is to be sure that our members have all the tools and knowledge and resources that they need to deliver the highest quality care to patients every day. So listening to what they need, what their struggles are, what their burdens are, is extremely important. And then the third thing I would recommend to her is that she get to know the staff and colleagues that she'll be working with. ASCO has a remarkably accomplished, skilled, motivated, passionate staff, many of whom have been with the organization for years, if not decades, who understand what ASCO can and cannot do and who understand what our members need. And she will be well advised to spend a good portion of her first few months on the job just listening and learning from her colleagues. CLIFFORD HUDIS: That's always good advice for anybody making a big career move. But, of course, the wisdom you bring to it is palpable and much appreciated. And I'm sure Julie will be taking your advice. And, by the way, so will I continue to do that even after you make your move. So speaking of your retirement, can you share with us a little bit about what it's actually going to look like for you? Is it about family? Or are you still going to have some professional engagement? Again, I suggest that there might be some already, but maybe you could expand on it. RICHARD SCHILSKY: Yeah. I'm still fully focused on my work at ASCO. And, of course, as you know, when I wake up on February 15, I will no longer be ASCO's chief medical officer. And it's going to be a bit of a rude awakening. Fortunately, I will be able to continue my engagement with ASCO through the TAPUR study as you mentioned. I will, of course, forever be at ASCO member and a donor to Conquer Cancer and be willing to serve the society in any way. I have a number of activities that I've been involved with even throughout my time at ASCO. Not-for-profit boards, for example-- I'm on the board of directors of Friends of Cancer Research. I'm on the board of directors for the Reagan-Udall Foundation for FDA. I plan to continue with those activities as long as they'll have me. I've been serving the last few years on the board also of the EORTC, the large European cooperative clinical research group. And I expect to continue in that role. Beyond that, I will see what opportunities come my way. I think one of the things about retirement if you will that I'm looking forward to is the opportunity to pick and choose what to work on based on what interests me without having the burdens of having a full-time job. On the personal front, of course, we're all looking forward to crawling out from the pandemic. I've basically been locked in my home outside Chicago since March. And I'm looking forward to getting back out to a little bit of a social life. As you know, I have two grown daughters and now three grandchildren, two of whom are in Atlanta, one of whom is near by us in the Chicago area. So looking forward to spending time with them as well. So it will be a change for me to be sure after working as hard as-- I feel like I've worked for really now 45 years since I graduated from medical school. But I also feel like I'm not quite done yet and that I still have ways in which I can contribute. I just feel like at this point, maybe it's time for me to choose how I want to make those contributions and spend a little bit more time doing some other things. CLIFFORD HUDIS: Well, both you and my predecessor, Allen Lichter, are modeling something, have modeled something, that I think is not often discussed but can be very important. For people and for institutions, change is not a bad thing. And setting the expectation that you will pour your heart and soul into something but not necessarily do it alone or forever and not prevent others from taking that role at some point, that's a really-- I think it's a selfless kind of sacrifice in a way. Because, of course, you could stay and do what you're doing for longer. But as you and I have discussed, there is a value for all of us collectively in having fresh eyes and new people take organizations in a new direction. That's how I ended up here frankly. And I think that's the kind of opportunity you're creating right now, something that should be celebrated in my opinion. RICHARD SCHILSKY: Well, thanks. And I couldn't agree more. When I look back at the arc of my career and having all the different kinds of leadership roles that I've had, I basically have made a job change every 8 to 10 years. I was the director of our cancer center for nearly 10 years. I was associate dean for clinical research at the University of Chicago for eight years, another position that I created from a blank slate at that institution. The exception was serving 15 years as a CALGB group chair. But that was a position I really loved and enjoyed and felt like at the end of the first 10 I hadn't quite accomplished everything I wanted to accomplish. But the point is that I think it is both necessary for organizations to have regular leadership change. And it's also refreshing for us as individuals. There gets to a point where you feel like you can do your job in your sleep. And I actually think that's a good time to make a change. Because if that's the way you feel, you're not being sufficiently challenged. And you're probably not being sufficiently creative. And so it's a good time to move on and refresh your own activities and give your organization a chance to bring in someone to hopefully build on whatever you've created and bring it to the next level. CLIFFORD HUDIS: Well, I agree with all that, although I think your comment there about doing the job in your sleep would not apply because I'm pretty confident that the environment and opportunities have continued to evolve in a way that has made it interesting from beginning to end. But you don't have to rebut me on that. I just want to thank you very, very much, Rich. As we set up this podcast, I expected that we would have a really fun and enlightening conversation. And, of course, you did not disappoint. We could talk for much, much longer if we only had the time. On a personal note to you and for the benefit of our listeners, I want to share that Rich has been for me a remarkable friend and mentor and colleague. I first met Rich at the very beginning of my career when my mentor, Larry Norton, pushed me out from Memorial into the larger world. And he did that first and primarily through ASCO and the Cancer and Leukemia Group. Those are really the two places where I was exposed to the world. And through the CALGB, Rich really began to offer me and others, many others, opportunities that shaped careers plural, mine and others. So when I got to ASCO as CEO, Rich was there. And I knew I could always depend on you to be clearheaded, intellectually precise, constructive, visionary. And the thing about you, Rich, is that you never would say yes to anything unless you knew for sure you could do it and indeed, I think, how you could do it. I always share this story which your staff at CENTRA pointed out to me. And I have to admit that I hadn't picked it up myself. But in all the years of now working down the hall from Rich, probably hundreds and hundreds of hours of meetings, he never has taken a note in front of me. And, yet, everything we talk about, every action item we conclude to pursue, they all get done. So I don't know, Rich. You have a remarkable way of organizing your thoughts and your plans, keeping it together, and getting things done. And I'm going to miss that tremendously in the years ahead. So, Rich, I want to say congratulations. Congratulations on reaching this really important milestone in your life. Thank you on behalf of ASCO and the broader oncology community and the patients we care for and their families for making the world a better place. And just as a small thing, thank you for joining me today for this ASCO in Action podcast. RICHARD SCHILSKY: Thank you, Cliff. It's been great. CLIFFORD HUDIS: And, for all of you, if you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And, while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.

In this episode of ASCO eLearning's Social Determinants of Health (SDOH) series, Narjust Duma, MD, moderates a discussion with ASCO CEO, Clifford A. Hudis, MD, FACP, FASCO and Sybil R. Green, JD, RPh, MHA, Director of Strategic Initiatives in ASCO’s Policy and Advocacy Department, on what ASCO is doing as a professional society to address equity as part of its mission.  Subscribe: Apple Podcasts, Google Play | Additional resources: elearning.asco.org | Contact Us   Transcript: PRESENTER: The purpose of this podcast is to educate and inform. This is not a substitute for medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. NARJUST DUMA: Welcome, everybody, to the second episode of ASCO's Social Determinants of Health series. My name is Dr. Narjust Duma. I am an assistant professor at the University of Wisconsin and also a thoracic oncologist. Today I'm joined by ASCO's CEO, Dr. Cliff Hudis, and Sybil Green, Director of Strategic Initiatives in the policy and advocacy department for ASCO. This series is a new initiative proposed by ASCO president, Dr. Lori Pierce. It focuses on increasing oncologists' awareness about the social determinants of health through the cancer care and how impacts our patients' outcome, including modifiable risk factors. This series is inspired by Dr. Pierce's presidential team of equity, every day, every patient, everywhere. In this episode, we look at what ASCO is doing as a professional society to improve health equity and cancer care. Welcome, Dr. Hudis. Welcome, Mrs. Green. First I would like to us what is ASCO doing as an organization in the matter of health equity and cancer care? CLIFF HUDIS: So I guess I'll start here. Thank you very much for spending some time with us on this. If you look at ASCO's mission, it is conquering cancer through research, education, and the promotion of the highest quality and equitable cancer care. So the idea of equity and our responsibility to address disparities is really in our organizational DNA. I have to point out something that many people may not realize. But when ASCO was founded in 1964, one of the seven founders was a black woman, Jane C. Wright. Dr. Wright died in February of 2013. But her father was among the first African-American graduates of the Harvard Medical School. His father was also a physician. And he was educated at what became Meharry. So I remind everybody of this as often as I can, to make the point that not only do we have an opportunity to advance equity and to deal with disparities in health care, but it's my perspective as a leader of ASCO that we have a special obligation and responsibility to do all of that. So we can talk more about it. But I'll just introduce maybe the answer by saying there are really two broad themes at work for us at ASCO. One is externally facing. And one is internally facing. The externally-facing work includes a range of projects and output that we can talk about a little more, but for example our position papers describing disparities and then identifying potential steps to take to address and solve them. But it also includes support for targeted research that is meant to narrow those gaps. It includes our educational efforts, both for our members and for legislators, advocacy for policy, and so on. And then on the internal side-- and here I'll ask Sybil to talk a little bit-- I think we've recently recognized our opportunity, and again responsibility, to think about the workplace itself and to think about our staff and to think about the activities and actions we can take and the roles we can model to create a better world. So I know I've been high level in my initial answer here. But the two domains again are external and internal. And then we can talk about some of the specific projects as we go on. NARJUST DUMA: Mrs. Green, I think it's very important to share about these internal aspects of ASCO because many of us are now aware as members, we see the surface. But ASCO is a large organization with many staff and members. So it would be great that you can share that with us. SYBIL GREEN: Absolutely. And thank you for allowing us to share that. I think Dr. Hudis pointed out some of what we've done since ASCO's establishments and really charging everyone on staff to really live out that obligation of equity, diversity, and inclusion. And so through our programs, our staff have to do their work, make sure that we are creating equitable opportunities for patients and physicians, but it starts at home. And so we have to make sure that internally, we are offering those same opportunities for our staff to engage because what we know is that when staff are engaged, and they have the opportunity to bring their true selves to work every day, they bring their personalities. They bring their lived experiences. And that all plays out in the work that we're doing on behalf of members, in their patients, but also for staff. I think if I were sum up where our program is going, similar to what Dr. Hudis has done, the three components are really enabling staff success. We ought to be able to do that for our staff internally. Every day we ought to provide opportunities for them to succeed. And then making sure that our partnerships-- those that we work with, whether it's in our publications, our meetings-- making sure that our partners goals and ideals align with ASCO's values and ideals. And all of this, of course, is in support of the greater ASCO enterprise, which is our members and the patients and of course, ASCO staff. NARJUST DUMA: And I think that it's really important-- I had the pleasure of interacting with several staff members with diverse backgrounds. And I think as we develop the mentorship program and other things, their input is diverse. It means we also are able to cover the trainees needs because every trainee's needs are different. And because I cannot give a talk or do a podcast without mentioning my grandma, [INAUDIBLE], I have to say that it's important to clean your house first before you go and try to clean other people's houses. I do promise it's beautiful in a Spanish. But I think it's important that everybody knows that internally ASCO is doing a lot of work. And I think it's important to talk about the grants in health equity. And I'm mentioning this because I haven't been doing health equity since I was a med student. And sometimes you find yourself not having enough grant opportunities. Now there is an increase. But when you compare it to other areas of oncology, you may be more competitive because there are less grants. And I think it would be great to hear from the both of you about the new health equity grants, the breast cancer disparity grant, and beyond. CLIFF HUDIS: Well I would just point out something to build on your comment, first of all. Since we were founded in 1964 til now-- so just over 55 years-- we've made unbelievable advances, I think, in oncology in general. Indeed the reason I as an old man chose to go into an oncology in the 1970s was that the vision ahead was that this was going to be an exciting field. And it has not disappointed. However there's a dark that I think we should acknowledge. The advances have not been fairly or evenly distributed. And indeed in some cases when we make massive improvements in outcomes in terms of what's possible with state-of-the-art care, we increase disparities because not every group catches up. And I say all that because it's important to understand that this is not about abstraction. These grants that address that gap are as or more important than the basic science grants that actually advance the biology and understanding in the first place. One without the other is incomplete. So I can't agree more that this is important. And actually from an investment or return on investment point of view, in some ways, these grants are an even better deal because we can rest many of these gaps in care delivery and in knowledge pretty quickly and narrow the gap. And we've seen it. I'm going to give you some examples in a moment. Whereas funding basic science, honestly, is a much higher risk proposition, if you think about it. So I don't mean to set up a false competition here. But I want to point out that there's a big reward. So here's an example. The plenary session abstract at ASCO two years ago now-- abstract number one, if you recall, was no moral less than an analysis of the impact of Medicaid expansion. And what did it show? It showed that with Medicaid expansion, those states that implemented it quickly narrowed the gap in time to initiation of therapy for curable colon cancer. It's a simple take-home point. I care passionately about this personally because these are differences in outcome that have been labeled as associated with race for many years or other specific ethnic facts. But really what they're about is nothing except unfair, uneven access to care in the first place on the basis of race. And it's something that we can address. So we are building out programs to address this through a number of granting mechanisms. For 2020 alone, there are going to be two Young investigator awards that are earmarked for underrepresented populations. And there's a career development award and another YIA, Young Investigator Award, in health disparities specifically. But this is just, I think, part of the issue. The other issue for us-- and actually a commitment going back for years-- is to do something about the workforce itself. And I don't have to tell you, but of course, there is a huge disparity playing out when we look at makeup of medical students in America. And it gets accentuated to the extreme when we look at black men. They are the most disproportionately underrepresented group right now. So how are we going to address that? And we're really proud this year to be launching a program that is aimed at newly-matriculating medical students building on a successful program in Boston that's been running for a couple of years already with Bob Mayer is the founder. And our goal is to the interest of specifically targeted populations, not just in medicine but specifically in oncology. NARJUST DUMA: Mrs. Green, you would like to add something about the grant and what is happening to support health disparities various research at ASCO? SYBIL GREEN: I'll just add the importance of any grant opportunity in any program being one to two. So it's one thing to be able to address bringing in the right medical students to be able to mirror the populations that they serve. It's something else to continue to support them along the way, and so not just stopping at the students, not just stopping at the research, but also making sure that was they're in practice they're supported. And a couple of grants that we've had for some time focus on quality, not just in ensuring that quality services are delivered, but actually helping practices to determine how to identify gaps in [INAUDIBLE] populations that are underserved because we may not be able to identify those same gaps that we would identify in majority populations. And so by giving them the tools to some of the other programs that ASCO has to be able to identify those gaps and then to support them along the way is really important. NARJUST DUMA: And I want to add to what Dr. Hudis mentioned about workforce diversity because this is one of my areas of research and passion. And it's extremely important to have a diverse workforce to represent the patients we're caring for. It's not only having a diverse workforce, but having a workforce that practices cultural humility. We cannot assume that we are proficient or we are competent in somebody's culture. I'm a Latina. And there are so many Latinos in so many different backgrounds that I cannot learn them all. And I think it's important that early interventions are-- because when you get exposed to a specialty early on during the training, that would change your pathway. I'm the daughter of two surgeons. I'm supposed to be a plastic surgeon. But a patient with cancer changed my life and my pathway. So we're able to support those students that have less resources and less access-- and that also includes rural students-- they may don't be black or Latino, they may be white, but they come from rural areas with limited resources-- we are sure that we meet the patient needs because there are aspects I don't understand. Like I'm in Wisconsin, and there are some aspects to farming I didn't know. Now I know when harvest is. And all of that allows us to plan appropriately. So I can see how important it is. And there's a task force that is run by Dr. Winfield, which I'm lucky to be part, that focuses on the workforce diversity. Along those lines, as a minority in medicine, I have seen up and downs of the interest in workforce diversity and health equity. I think many events in 2020 helped a lot of people open their eyes or be more conscious like, oh, that's not isolated. That happens in my back yard. It happened in Kenosha, Wisconsin. But we want to hear how is ASCO making these things long term, how the internal and external changes are going to be long term? And I will start with Mrs. Green and then go to Dr. Hudis. SYBIL GREEN: So in terms of making it long term, it can't be one and done. I think quite often when we focus on equity and diversity issues, we always look at diversity first. And so whether it's workforce or whether it's increasing opportunities for access, you can't just look at the numbers. You have to also think a little bit deeper. You have to think about culture. And so culture with humility, like you mentioned, Dr. Duma, is important, but making sure that attitudes are changing along the way. And that happens through self-awareness. That happens through understanding. And I think that ASCO plays a real role in making sure that our members understand what the issues are and how to dig past those things and provide them with the tools to be able to [INAUDIBLE]. ASCO I think, is not unique. And the idea that this is all new to us has gotten a lot of attention because of some of the social and racial injustice. But what that means is that our members now are probably more interested in ensuring equity than ever before. But we have to teach them how to do it. We have to teach them how to speak the language. We have to teach them how to be more aware, both in their own organizations, at ASCO internally, and for their patients. And so it's a cultural change. It's not going to happen overnight. It's gradual understanding of the dynamics, gradual understanding of different peoples goals, and meeting them where they are, so that we can help them to move along, so that we can come to a more equitable and just [INAUDIBLE]. CLIFF HUDIS: I think one of the things Sybil and I spoke about this summer is we launched our internal EDI effort-- relates to this. And that is this is not about identifying a leaky pipe and patching it and saying, well, we're done now. This is actually, in my view, a permanent change in the way we see work and the way we see our growth. So the goal is to reach a specific landmark. The goal is to change how we think about our work and how we think about our role in the world, so that we're constantly improving. And it's a journey, not a destination, I think, which sounds trite. But that's the spirit of it. And it gets to your question about how we make sure that the commitment is continuous and not just while it's [INAUDIBLE] and exciting. And I think we are committed and dedicated to that. I do want to present a related challenge because it's something you said really sparked this thought for me. As a physician, when did you know that you wanted to be a physician? How old were you? NARJUST DUMA: I was 5. CLIFF HUDIS: And, Sybil, when did you know what your career path was going to be? SYBIL GREEN: I was 9. CLIFF HUDIS: That doesn't support my thesis [LAUGHS] [INAUDIBLE]. So here's the issue. The issue of burnout in medicine right now is getting a lot of attention. And one of the reasons for it, frequently given, is that doctors on average decide to commit to their careers a decade younger than most people on average commit to other careers. You're an exception, Sybil, so I should have pretested the question. But the issue is we're not here to talk about burnout today, even though that's really important. The issue is this. In order to ultimately address the makeup of the population of physicians, we need to reach deeper and further into precollege communities. And we need to show people that they could have lives in science and health care and in medicine and maybe specifically oncology. And I'm just pointing out to you that that's a daunting challenge for a professional society like ASCO. That's not our audience. We don't have a natural connection there. And one of the things that we're working on right now is identifying programs that have worked, that exposed high school students from previously excluded populations or communities to medicine, so that we can spark that passion before college, not during college, and therefore have the commitment that it takes to go far into medicine. And I'll just close by saying something that you hinted at but needs to be said. The reason to have diversity in our workforce is not that an Asian patient needs an Asian doctor. It's that an Asian patient needs a practice that has Asian doctors in it, so that the practice as a whole is able to be culturally sensitive and able to relate and communicate and support them because I think sometimes this issue gets oversimplified as well. SYBIL GREEN: So Dr. Hudis, your theory is not completely [INAUDIBLE] I think it's relevant to this conversation because while I knew what I wanted to do at 9, what I didn't have was the representatives in the community. I didn't have the mentor. Interestingly enough, I had more mentors in pharmacy than I had in law because I saw pharmacists who looked like me. I happened to live in a town where there was a historically black college with [INAUDIBLE]. And so I saw people look like me. And it made it a lot easier for me to reach out to them, for them to mentor me, for them to start talking to me about what equity in health care looked like. That really wasn't until I was in college. But the truth of the matter is for most diverse students, most minority students, that doesn't exist. And I think that that's where ASCO's mentoring programs are really rich. You have the opportunity to do that. NARJUST DUMA: And I think this is important because you can do what you can see. And that has been proven over and over again. We unfortunately are running out of time. But I want to ask the final question. Like a manuscript, like a study, everything has limitations. And I think it's important that we talk about the limitations of ASCO doing this work because realistic expectations are helpful so we don't get disappointed when we have big expectations that may not be met. So Dr. Hudis, what are some of the limitations of ASCO to help equity work now? CLIFF HUDIS: You're right, it's a huge issue. If you think about where our scientific focus is, we can measure the disparities or the difference in outcomes. And we can write a paper about that but when you really get to addressing the reasons for it, it extends far beyond what we can do. So I guess our limit is we can call attention and rally colleagues and collaborate across the House of Medicine and broadly into Congress, where we can make a difference-- or to the United Nations and World Health Organization. But we can't do this heavy lift alone. We need other colleagues who agree who are willing to invest time and money to make the change. SYBIL GREEN: And I would add partnerships because as much as we're talking about social determinants of health, we recognize that all social determinants of health are not health related. They're not [INAUDIBLE]. And many of them live and operate outside of the realm of health care. But what we can do is bring our expertise to the table about the impact of those things, so that our partners stand in their own world, in education, in criminal justice, in financial assistance, how that can help really change the outcomes for patients. I think at ASCO, we've got that expertise. And we can do that. NARJUST DUMA: Thank both of you for your time. Thank you, everybody, for joining us for the second episode of ASCO Social Determinants of Health series. Please keep up with us. You can subscribe. You can see this on Facebook, YouTube-- when it becomes available. We'll continue to explore the social determinants of health and cancer care. You can leave feedback or emails, any questions to the professional development, at asco.org. And I thank you for your time. And have a wonderful week. PRESENTER: Thank you for listening to this week's episode of the ASCO eLearning weekly podcast. To make us part of your weekly routine, click Subscribe. Let us know what you think by leaving a review. For more information, visit the comprehensive eLearning center at elearning.asco.org.

In the latest ASCO in Action podcast, ASCO CEO Dr. Clifford A. Hudis shares a quick preview of what's to come for the 2020 ASCO Advocacy Summit and Week of Action, which will take place September 14-18. Typically, ASCO volunteers from across the country gather in Washington, D.C. to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research through in-person meetings with their Members of Congress. Due to the COVID-19 pandemic, the 2020 ASCO Advocacy Summit will be a virtual event, but participants can expect the same important advocacy and education opportunities that the event provides every year. All ASCO members are encouraged to participate in the Congressional Week of Action by signing up with the ACT Network (through the Advocacy Center on ASCO.org). Subscribe to the ASCO in Action podcast through iTunes and Google Play.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at “Podcast dot ASCO dot org” (podcast.asco.org) The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer. I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to share with listeners a preview of the 2020 ASCO Advocacy Summit and Week of Action taking place September 14-18. Typically, ASCO gathers volunteer advocates in Washington, D.C., in September for education sessions and in-person meetings with their Members of Congress. Due to the COVID-19 pandemic—like so many events scheduled to take place this year—the 2020 ASCO Advocacy Summit will be a virtual event, but that said, participants can expect the same advocacy and education opportunities that the event provides every year. ASCO volunteers will meet with Members of Congress and their staff by phone or video to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research. Advocacy Summit attendees will also attend webinars to receive education and training on lobbying Congress and the current political landscape. What is different this year is our online Week of Action, which will give all ASCO members an opportunity to advocate on critical issues of great importance to the cancer care delivery system in the United States. Participants in the Week of Action will amplify the Advocacy Summit’s messages through email and social media messages to Members of Congress using ASCO’s ACT Network. And, it’s easy to get involved and make your voice heard. You just need to click on the link to the ACT Network in the Advocacy Center on ASCO.org and sign up to receive ASCO ACT Network emails. Then, you’ll get all the information on the fastest and easiest ways to contact lawmakers delivered directly to your inbox. We hope you will participate as much as you can—the effort will take just minutes. Even one message a day by every ASCO member to your representatives in Congress will have a tremendous impact. During the virtual Advocacy Summit, which will be held in the middle of the Week of Action on September 16, ASCO volunteer advocates will have their virtual meetings with Members of Congress and their staff. The three issues or “legislative asks” that they will be discussing will be the same asks that ASCO members will contact their Members of Congress about during the Week of Action. One, we will ask Congress to support legislation—The CLINICAL TREATMENT Act, which will give all Medicaid beneficiaries coverage of routine costs when enrolled in clinical trials—coverage Medicare and private insurance plans already provide. The importance of improving health equity has become even more apparent during the COVID-19 pandemic, and this legislation takes us one step closer to that goal. Two, ASCO volunteer advocates will request lawmakers to co-sponsor the Safe Step Act, which will help protect patients from harmful step therapy protocols, which ASCO believes is never appropriate in the treatment of cancer. And three, we’ll address the impact COVID-19 has had on cancer practices and research. Specifically, advocates will ask Congress to endorse maintaining reimbursement flexibilities for telehealth, as many oncology practices have rapidly transitioned to telehealth to ensure patients continued receiving treatment during the pandemic.  We’ll also be asking Congress to provide emergency funding to the National Institutes of Health to mitigate disruptions caused to labs and clinical trials by COVID-19, and to restart research across the county. These are the same issues that participants in the Week of Action will be advocating for all week long in their outreach to Congress. The goals of the Advocacy Summit and Week of Action are to advance priority legislation, amplify the collective voice of the cancer care community on Capitol Hill, and to get ASCO members involved in advocacy initiatives. Members of Congress and their staff have grown accustomed to virtual constituent meetings, and personal stories continue to be the most effective form of advocacy, so the Advocacy Summit and Week of Action—even virtually—remain critical to ASCO’s larger advocacy efforts. In addition to the meetings and messages between advocates and lawmakers, the ASCO Advocate of the Year and the Congressional Champion for Cancer Care will be named during the Advocacy Summit. In closing today, I encourage everyone listening today to follow the Advocacy Summit through social media by way of the hashtag ASCO Advocacy Summit (#ASCOAdvocacySummit) on Twitter AND to participate in the Week of Action through the ACT Network. A link to the ACT Network and all the information you’ll need to participate in the Week of Action is available at ASCO dot org slash ASCO Action (www.asco.org/ascoaction). Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode. The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at “Podcast dot ASCO dot org” (podcast.asco.org).

American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Piyush Srivastava, the past chair of ASCO’s Clinical Practice Committee, in the newest ASCO in Action Podcast to discuss the recently released ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic. Dr. Srivastava was instrumental in developing the report, which provides detailed guidance to oncology practices on the immediate and short-term steps that should be taken to protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis. Subscribe to the ASCO in Action podcast through iTunes and Google Play.       The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.   This ASCO in Action podcast is ASCO's series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.   I'm Dr. Clifford Hudis, CEO of ASCO. And I'm the host of the ASCO in Action podcast series. I'm really pleased to be joined today by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee. Dr. Srivastava is also a practicing gastrointestinal oncologist, the regional medical director of the End of Life Options program, and the director of Outpatient Palliative Care at Kaiser Permanente Walnut Creek Medical Center in California.   Today, we're going to talk about the recently released ASCO Special Report, A Guide To Cancer Care Delivery During The COVID-19 Pandemic.   Dr. Srivastava was instrumental in developing the report. And we'll speak today about the guidance that the report provides for oncology practices as they return to more routine care delivery. Piyush, thank you so much for joining me today.   Thank you, Dr. Hudis for taking the time to speak with me. Just before we start, I just want to say that I do not have any relationships to disclose. So thank you.   Thank you very much for joining us today. Now, just to provide some context, today as we speak, we're approaching month five of the COVID-19 public health crisis in the United States. We've had more than 2.15 million confirmed cases of the virus and well over 100,000 deaths.   In fact, as we record this today, several of the largest population states in the United States-- California, Texas, and Florida-- are just reporting their largest single-day increases in cases and the health care systems in some of their big cities are approaching the kind of near breaking point that we saw earlier in New York. So the problem is still very much with us.   When the outbreak began, oncology practices nationwide immediately began making operational changes designed to protect the safety of patients and the safety of staff. This meant adjusting to resource shortages that were unfolding and complying with national and state restrictions on elective procedures, among many other things.   Today, communities across the country are in varying states of recovery. And as I just described, some of them actually are probably pausing their recovery right now. Either way, they are facing a real transition in terms of oncology practice. And some are returning to something more like routine care while continuing to be acutely attuned to protecting the health and safety of both patients and staff.   So Dr. Srivastava, could you start us off and tell our listeners just a little bit about what's happening in your own practice and how you have been adapting to the changing circumstances?   Of course. I would be very honored to share my experiences at Kaiser Permanente in Northern California. So at the start of the pandemic, we were very fortunate to be nicely set up to provide care remotely. We've had a very strong existing telehealth structure. So we were quickly able to adapt to the pandemic situation.   Initially, we nearly went 100% remote, with doing all of our new consults and chemo checks via video visits and telephone visits. If a patient needed some more attention, to be seen by a care practitioner, many times that we would coordinate with the on-call physician on site, who would see the patient on the chemotherapy infusion chair.   We also looked as an institution which services we could provide remotely and take off site and so that we didn't need to bring the patients into the cancer center. For example, we activated our home health nursing team to be able to provide port flushes in the home setting.   We also made a very conscientious effort to see what treatments and what procedures that we could postpone or actually decrease the frequency or increase the timing in between events. For example, bisphosphonate administration and port flushes, which we increased to do every three months.   What was extremely eye opening and inspiring to me is a large organization such as Kaiser Permanente was extremely nimble and flexible and was able to respond to the outside pressures. I believe, when I speak to my colleagues across the country, that many people experienced the same things with their institutions. And their institutions responded very flexibly to the ongoing pandemic.   Thanks very much. It's really interesting, I think for me, and I'm sure for many of our listeners, to hear how you adapted but also to compare that with their own experiences. It sounds to me like some of the key features were clear eye on the safety of patients and staff but also having a structure that respected the needs of the clinicians from the beginning. And then, of course, understood that the flexibility overall was a key attribute. And I just think that's something that many people will be reflecting on.   As we hit it from that one in a sense, forgive me, but anecdote, which is how one center, one operation adapted, I wonder if you could talk a little bit about ASCO's role in providing the more general guidance that you helped to develop. Why did this society feel it was necessary to provide guidance at that level?   Yes. So as we are all extremely aware, many individual health care professionals, institutions, and health systems look to ASCO for mentorship when it comes to oncology care. So this current pandemic was no different. I believe ASCO felt a strong duty and a responsibility to partner with the oncology world to ensure the highest quality and efficiency of cancer care and delivery through this pandemic.   Also, the beginning of the pandemic, there was a lack of really clear guidance from federal and state agencies. So cancer care providers and administrators looked to ASCO to help develop their plans of providing care during the pandemic. Now, also opening and ramping up as well, they're looking to us.   I see. So as we think about staff at ASCO headquarters, it's really pretty straightforward on a daily basis. Our decisions to open headquarters, for example, or not are predicated, number one, on the safety of our staff. So when you look at the Special Report, what would you say was the one or the several overarching goals that drove the development of the Special Report?   So when constructing the report, we did very much realize that there are so many varied practices across the country, really around the world, right? For example, we have small rural practices. We have medium-sized private practices. We have academic centers, and we have hospital systems. And all these organizations look to ASCO for cancer guidance and guidance to cancer care delivery.   By no way were we going to be able to solve individual operational care delivery issues for each practice. So the Special Report is made to serve, if you will, as a starting point or a launching pad for individual institutions to develop their own policies and operational adjustments.   So what I would like to do now is maybe just dive a little bit deeper into some of the specific policies and practices that were outlined in the report. And as I look at it, it was really broken down into stages of patient care.   So for example, before a patient even arrives on site, many practices are in a sense pre-screening them or triaging them. What are some of the methods that you have seen put into place and that have been effective that we should recommend to practices just getting open?   So the Special Report lists out very clearly sequential steps to consider in safely bringing patients into cancer centers. And I'll highlight a few of them, which I feel is extremely important. The first step is to actually reach out to the patient well before their scheduled visit to the cancer center. So if we can call these patients and family members well before their visit, we can educate them as to the process that they'll experience when they come into the cancer center.   Allow them to ask questions and to give the reasoning behind or the why to we are doing this. I think that will go a long way. So transparent communication, I think, will reduce anxiety and fear.   I also believe an effective second step was to do a quick check in, anywhere from 12 to 48, 72 hours prior to the actual visit, depending on what your operations would allow, just to check in to make sure that you're screening for the COVID symptoms and the patient doesn't test positive to any of those symptoms.   I may just add also in the first step, when you reach out to the patient well before their appointment, that's also a good time to screen for COVID questions. And then a third implementation can be as a single point of entry.   So when a patient comes into the cancer center, there's one point of entry so that way a temperature could be checked, a patient could be screened again for those COVID symptom questions. And so that when that patient arrives inside the cancer center, there's been essentially three checks and balances of checking for COVID-19 symptoms.   So this provides obviously the safety to minimize the risk of bringing COVID into the cancer center. But I also think an extremely important added benefit is that the staff and providers will feel confident and safe that the institution has done these many different steps to ensure their safety as well and to minimize their risk of exposure to COVID.   I see. So that's one part of this. Now, the implication in all of this is the volume coming through the clinics is likely to be lower. And one of the ways in which it is controlled, of course, is through the reduction of less critical face-to-face encounters and arguably an increase in telemedicine. What are some of the considerations that you think oncology practices should factor into their use of telemedicine in care delivery?   Yeah. That's actually a fantastic question, because telemedicine has really-- well, telemedicine was forced upon most institutions. And the institutions had to really find an effective way to provide care remotely. So it's a very interesting and important topic. For example, I think one thing that I personally struggled with, and I think my institution struggled with is, who is the right patient for telemedicine?   So the report talks about specific patient categories that you can think of that would be easier to provide patient care remotely. So for example, those that are not requiring in-person physical exam, those who may not actually actively be getting chemo treatment, those that don't need any in-office diagnostics. So don't necessarily need lab work tied to that appointment or you don't necessarily need imaging exams at that moment.   Other visits that the report recommends to think about is follow up. So follow up could be done through telemedicine. Or those that are on oral oncolytic treatments. And so it's a quick check in just to make sure that they're taking the medication and the adherence is high could be done by video or by phone.   A couple of things to consider with telemedicine, obviously, is the audio and visual capabilities. And so even in the Bay Area in California, we do have spots that don't have the best reception. And so that can become problematic. So that's something to also think about.   The other sort of counterbalance or countermeasure to this is just to make sure that patients feel that they're being taken care of and they feel satisfied. So in my own practice, I've now adopted that when we finish a video visit or we finish a telephone visit, I let the patient know that I have felt comfortable with the interaction and that I felt that I was able to accomplish the care plan and execute the care plan as needed by the video and phone. But then I ask them, do they feel comfortable and are they OK proceeding this way or do they prefer face-to-face visit.   Yeah. I think that's an interesting observation about telemedicine. I think everybody is feeling their way right now and learning. And we want to be careful not to go too far away from the direct physical encounter since so much can be lost without those subtle cues from body language and classic physical findings as well. Now, coming back once more to the workforce, the report addresses how we maintain a healthy workforce.   And it specifically, I think, gets into questions of testing and scheduling and even dealing with stress. Can you walk through that a little more about antibody testing or saliva or nasal swabs and the frequency and exactly what facilities and practices should be thinking about for their staff.   Sure. And this is an extremely hot topic, and the interesting thing about this topic is it can vary widely just depending on what's available at that moment in your location, what the county is ordaining and what the state is ordaining as well. So there's a bit of variability.   But what the Special Report does very nicely, it lays out considerations for institutions to think about when they are caring for the workforce, both physically and emotionally. So this Special Report lays out some PPE guidelines, and really it's based on what the CDC is recommending.   And as we know, as one of the largest sort of scientific research-based organizations, it's important that we bring the CDC's sentiment forward when we talk about PPE, especially with PPE stewardship as this goes on for some time, we may have some issues with the supply chain.   The other thing the Special Report calls out is to really have institutions make sure that they are putting their health care practitioners in the forefront. So checking in with health care practitioners to make sure that they are not ill, that they're feeling OK, that they haven't been exposed to anybody outside of the medical system. And I think what's really, really special about this report is that it really talks to the practitioner's well-being. I think this is scary for any provider in the front line.   We are also worried about our own health and what we can bring back to our loved ones outside of the medical center. But also, I think all of us as oncology providers are feeling a little disillusioned and a little saddened, because we are not able to provide oncology care like we normally have been.   And so that's a huge adjustment for the oncology provider. And of course, that comes with some moral distress. So the report also calls out for institutions to check in with their health care providers to make sure that their emotional well-being is good and to also make sure that they feel that their family and loved ones are safe at home. So I think that was a really added benefit.   Yes. Really important to acknowledge the importance of all of that to the individuals. And it is not just about narrowly the safety of the surfaces and workspaces they're in, but really in a sense their holistic experience in life. I want to turn to the broad public approach to cancer care and focus on the corners that we cut, if you will, in going into this crisis, the compromises with old ways of doing things that we very quickly adopted.   The report focuses on some of those immediate short-term steps that we took. And I think looking at the effectiveness of that, I can tell you that I asked the ASCO leadership on the staff side and on the volunteer side why those adaptations couldn't just be our new permanent normal.   That is to say, if it was safe enough to do telehealth in April of 2020, why isn't it safe enough to do it forever? So that was the nidus of our Road to Recovery Task Force. And I know you sit on the group focused on care delivery. What do you think we can expect from that effort?   Yeah. And this is fantastic. I am honored to be sitting on the Road to Recovery Task Force, because I think this is an issue that's facing every oncology care provider in the country and, frankly, around the globe. And the task force is composed of a group of really active and very intelligent oncology providers who are putting their minds together collaboratively to see how we can continue to provide cancer care in an efficient and in a high-quality manner moving forward beyond the pandemic.   And as you said very nicely, Dr. Hudis, we have gained several insights through our care over the last few months, and can we harness those insights and continue to practice oncology in a very efficient and high-quality manner?   So the task force is extremely comprehensive. The group is addressing several buckets, if you will, that are very pertinent to oncology care and delivery. So they're looking at health equity. They're looking at resetting clinic and patient appointments.   They're looking at practice operations, telemedicine, home infusion. I know that's something that we've all been grappling with. Financial assistance to practices, which is extremely important when we look at the economy around us.   Quality reporting and measurements. So we want to make sure-- we want to challenge ourselves to make sure that we are practicing the highest-quality cancer care that we can. Utilization management. So that's also extremely important as we are looking at the economy around us.   Psychosocial impact on patients. So this has been obviously extremely traumatic for patients in their very vulnerable state. The task force also is looking at provider well-being, which once again, I can't reinforce how important that is as we go back into somewhat normal operations, whatever that normal may be, but looking at the sort of stress that the providers are feeling in that.   And then ongoing preparedness I think, which is extremely essential, because we just don't know what the virus will do over the next year and what might also come in the future. So the task force is extremely collaborative, extremely thorough. And it is a group of very active individuals on oncology care that are bringing their brilliant minds together to come up with some guidance.   Well, I think that's really great. As we wrap up now, I wonder if at the highest level if there's a single or several major takeaways that you want listeners and our entire community to take away from these recommendations.   Yeah. You know, I've actually had some time to reflect. It's been a very privileged experience for me to be a part of this and to be a listener and to be a learner from all these brilliant minds around me who are putting their heads together to accomplish this. I find that recommendations in the Special Report to be very thoughtful and very comprehensive.   I do hope practices remember that these are actually guidelines to help them develop and change policies at individual institutions. I also hope that oncology practitioners and administrators remember that we're all in this together. And so there is going to be an ever-changing environment.   So I hope that this report is just a start of a collaboration that can be ongoing with ASCO and with oncology providers around the world. I am fully confident that ASCO is a tremendous and a large resource for us in the oncology world to be able to accomplish collaboration and to actually uplift and maintain cancer care during and after the pandemic.   Well, that's really, I think, is nice and as great and complete a summary as one could hope to hear. So I want to thank you, Dr. Srivastava, for speaking with me today. I'm really grateful to you for your time on this whole initiative and the effort that you've put to it as well as, of course, for the time today.   I appreciate it. It has been a great honor. And so thank you very much to you, Dr. Hudis, and thank you very much to the ASCO staff, who do a tremendous job on a daily basis to make sure that we are doing the best we can.   So the Special Report, and later, ASCO's Road to Recovery, are all part of ASCO's larger commitment to providing information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer, both during the COVID-19 pandemic and then well beyond it.   We invite listeners to participate in the ASCO survey on COVID-19 in Oncology Registry or ASCO registry. This is a project where we are collecting and then sharing insights on how the virus impacts cancer care and cancer-patient outcomes during the COVID-19 pandemic.   We encourage all oncology practices to participate so that we will have the largest possible data set and represent the full diversity of patients and practices across the United States.   I'll remind you that you can find all of our COVID-19 resources and much more at asco.org. And until next time, I want to thank everyone for listening to this ASCO in Action podcast.   If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. And you can find all of the shows at podcast.asco.org.

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Jonathan Marron, incoming Chair of ASCO’s Ethics Committee and a lead author of the new Ethics and Resource Scarcity: ASCO Recommendations for the Oncology Community During the COVID-19 Pandemic.  In this episode they discuss ASCO’s recommendations, why ASCO developed this guidance, and what patients, families, and the entire medical community need to know about allocating limited resources during the COVID-19 Pandemic.   Subscribe to the ASCO in Action podcast through iTunes and Google Play.  The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offers enriching insights into the world of cancer care. You can find all of our shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series, where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Dr. Clifford Hudis, and I'm the CEO of ASCO. And I'm proud to serve as the host of the ASCO in Action podcast series. Today, I'm very pleased to be joined by Dr. Jonathan Marron, incoming chair of ASCO's Ethics Committee and a lead author of ASCO's recent recommendations for the oncology community on ethically managing scarce resources during the COVID-19 pandemic. Dr. Marron is also a bioethicist at Boston Children's Hospital, a pediatric oncologist at Dana Farber Cancer Institute, and he is on the Center for Bioethics teaching faculty at Harvard Medical School. Today, we're going to talk about those recommendations. And I'll note that they were published just recently as a special article just in early April in the Journal of Clinical Oncology. We'll focus specifically on the reasons that ASCO took this step and what it is that oncologists, patients, families, and the entire cancer care community need to know about this issue. Dr. Marron, thank you so much for joining me today. Thank you so much, Dr. Hudis. It's really a pleasure to be speaking with you, and an honor as well. Before we get started, I do want to just point out that I have no conflicts of interest to disclose. Well, that's great. Now, just to provide some context as we start this discussion, it's the middle of May as we're recording this. In the United States, the COVID-19 public health crisis bubbled up to awareness a little bit in January, became seemingly near threat in February, and seemed in the public's eye, I think, to breach our shores at the beginning to middle of March. So we're about four months, more or less, into this public health crisis. The US has had now about a million and a half confirmed cases of the virus. And I think this week, we crossed the 90,000 number in terms of deaths from the virus. From the very early days, there was-- and we all remember this-- an extraordinarily emotional and widespread concern that medical resources, and especially ventilators, but also medications, as well as space, critical and intensive care beds-- those three things, that they would be stretched, that some communities would be especially hard hit, and that, as a consequence, access to those resources might be limited. And when that arose as a concern, what followed, especially for people who work in this field, and bioethicists in general, as well as everyday clinicians, was the very real possibility that they would be forced to make some painful and difficult choices. And I'll say some of our members wrote about these experiences as well in ASCO Connection and elsewhere. So can you now maybe help our listeners understand why ASCO in particular thought that this situation needed to be addressed and why we decided to provide the very specific guidance that you took part in creating in the form of these recommendations? Absolutely. So you really highlighted a couple of the main questions and concerns that we had that we wanted to do our best to address, in the sense that at the outset of the pandemic, it was really difficult to tell what direction things were going to go and just how bad everything was going to get. Seeing the experience in China and seeing the experience in Italy, there was significant concern that, as you mentioned, our health care system would not be able to support the critical care needs that we would have. There is a long history of people thinking about how to utilize and best utilize resources like this in the setting of scarcity. One of the concerns that comes up whenever you have to make these difficult or realistically impossible choices is how you're going to do so. And so really, that's where we came, as oncologists and as the ASCO community, to try to figure out how we could best represent the oncology community and to ensure that cancer unto itself was not going to keep a given patient from having a fair chance to access these potentially lifesaving resources, even in the setting of a public health crisis like this, even in the setting of scarce resources. So I remember as this was being developed having conversations with, I think, you and other members of the panel. I'm going to push a little bit on at least one of the areas that I think is really a concern but can be misunderstood. And that is this high-level statement you just made that people with-- if I understood correctly-- that people with cancer might find themselves discriminated against in these moments of triage, fundamentally. There's one ventilator. There are three patients at need. And God forbid we're ever in this situation-- how do you decide who gets it. On the one hand, of course, there's a fairness doctrine. But on the other, there is a medical reality. And cancer is not one thing. So could you just talk a little bit about what we mean when we say protecting the cancer patients? And let me be clear. We're not saying that cancer as a diagnosis, stage, prognosis should be ignored exactly, right? Absolutely. And I think what you said there really is one of the most, if not the most, important aspects here, that there are a couple of different ways that you can go about trying to take, as the example that you had of the three patients, and decide which of those three will get the ventilator. If not the perhaps fairest way would be simply to make a choice at random and say each of those three individuals has an equal chance at it, and we'll flip a coin or do some other random way of deciding who will get it. That's certainly fair. But some people would say, you know what? They may not be equal in all ways. And if we're trying to maximize our resources and maximize the potential outcome benefits of these scarce resources, we want to do something more than just do something-- choose randomly. And we've actually learned in the past from work with community groups that people don't love the idea of randomly choosing things like this, in a public health emergency or otherwise. And so then-- the question, then, is OK, so how are you going to make that choice. If we're trying to maximize health care outcomes, and which you usually think about that being survival, we want to use medical information. But then the question is, what is the information that should be used. So one of the concerns is that there could be certain disease processes, cancer or otherwise, that would be seen as exclusion criteria. That's to say, OK, we have these three patients. We have one ventilator. Patient one has cancer, so therefore we're going to not even give them a chance at that ventilator. And that's really where this comes in. That's not the way to do this. Cancer absolutely should come into the consideration. But that patient's specific cancer-- their diagnosis, their prognosis, the medical information-- the best medical information that we have, the best evidence-based medical information that we have about their specific disease so that we can make an informed decision, or at least a maximally informed decision about who is the most likely to survive if they are given access to the ventilator or ICU bed or whatever it might be. Yeah, I think this was one of the areas that you had to read somewhat carefully and be patient to understand the context, because if I understand correctly-- and with no disrespect to our colleagues outside of oncology-- one concern is that in the ER, a patient who once had cancer might just be, in a blanket way, discriminated against. But look, I was a breast cancer doc for 30 years. Most of my patients were, frankly, . cured. And the fact that they had breast cancer in 1996 is of essentially no meaningful relevance to any medical decision, almost. I'm oversimplifying it here, rather. But our concern, I think, was that in the front lines, under duress and pressure, that mistaken judgments might be made, and we wanted to advocate for that. Is that-- I may not have said that so elegantly. But is that-- that was one of the concerns in the other direction, right? Absolutely, yeah. And it's certainly conceivable that somebody, in a very well-intentioned way, would think that OK, this patient currently has cancer or at some point in the past had cancer. And as wonderful as the electronic record is, sometimes it can be difficult to tell if something is a current medical problem or a past one. But either way, simply the diagnosis of cancer is not the be-all, end-all. And there needs to be a thoughtful and ethically rigorous process by which these decisions are made. And that's what we hoped to inform with the paper and with the recommendations. You know, it's interesting. And if I may just think of the sweep of time, I always put things in the ASCO context. So the society was founded in '64. The medical oncology boards were in the mid-70s for the first time. The curative systemic therapies for testes cancer, for the lymphomas were a little before that, obviously, and in that general era. It is quite a testimony, when you think about it, to the advances in oncology that we're now worried that people will, in a sense, make too much in the negative direction about prognosis of a cancer diagnosis. And I'm thinking of the last few years, where suddenly there are tranches of survivors of melanoma and non-small-cell lung cancer and other diseases that historically had a very poor prognosis, and now they may still have, on average, a bad prognosis. But there are survivors and long-term survivors with formerly incurable diseases. They need to be protected, in a sense, from this one-size-fits-all judgment, right? Absolutely, yeah. And as a pediatric oncologist, I run into that every day that people assume that, oh, my gosh, children who are diagnosed with cancer, that they're dying left and right. And people are generally quite surprised to hear that we have an 85% survival rate in children with cancer. So that certainly would be a concern in that population as well, that if there were the setting of resource scarcity that a child could come in and say, OK, well, they have cancer, even if it's active cancer, but they, in many cases, would be expected to have a very good chance of survival. It's interesting you bring that up, because I will say in a distantly related aside, certainly one of the more interesting and repetitively surprising conversations many of us have is the one that involves pediatric oncology with friends and neighbors or whatever who aren't that familiar. They're always surprised at the high success rate in that field. And it just makes the point that we can't let a diagnosis stand as the only interpretable fact. So look, these recommendations establish an important principle. A cancer diagnosis alone should not keep a patient from a fair chance to access potentially life-threatening-- or rather life-saving, sorry, resources, even during a public health crisis. But let's go a step further. One of the other recommendations in there were that decisions regarding allocation of scarce resources should be separated-- separated from bedside decision-making. This one, I struggled with as a reader as well. And I wonder if you could explain to our listeners what the intent or thinking behind this recommendation would be. As I ask that question, in my mind's eye, I picture I'm called to the ER. The ER doc is looking at my patient's dropping O2 sat and is turning to me for advice and guidance and understanding of the disease specificity or the specific disease circumstances in this patient so they can make the triage decision. And I'm struggling to understand what we actually mean by decisions regarding allocation of scarce resources should be separated from the bedside. So ultimately, that piece comes down to the fact that we as humans and decision-makers are imperfect. And it would be unreasonable and probably impossible to expect that any one of us, as a clinician or just as a person, could reasonably weigh all of these different things simultaneously, because there is ultimately a huge conflict of interest in saying that I am the clinician taking care of this patient in front of me, but simultaneously, my job is to steward the resources for my institution or, even more broadly, the resources for the entirety of the country or whatever I might consider to be my patient population. And so what we are trying to-- the message we were trying to send with that piece is not only that it shouldn't be the oncologist who's making that resource allocation decision, but it's actually not the emergency room clinician who should be either, because it's just completely unreasonable to expect someone at the bedside to be weighing those two things at the same time and to be making an unbiased decision. Well, apart from the pandemic and the specific kinds of acute resource shortages that the paper addresses, the truth of the matter is, we've been talking about finite healthcare resources and hard choices for years. And these questions often are raised in the context of oncology. So I want in that way to just ask you about something that you mentioned at the very beginning, but I'm going to push you to a more precise answer, the recommendation that says allocation of scarce resources in a pandemic should be based on maximizing health benefits. And you alluded to that a little bit. So can you just expand a little bit on what it is you mean? You've said overall survival is often taken as one. But of course, there are trade-offs. There's quality-of-life issues. There are a number of people who might benefit modestly, more people, fewer people, benefiting more deeply, whatever it is. So I won't hold you to this exactly, although it's being recorded. But what do you think should be the goal when we talk about maximizing health benefits? What exactly does that mean? So this is really where we get into the weeds with this, as you were sort of alluding to. So certainly, we want to save the most lives. I think there is general agreement from most people out there that that's a reasonable and a fair way to look at this. One of the questions that's been debated most over these past couple of months as we've been thinking about these things, perhaps more than we ever have before, is whether we want to somehow integrate the idea of saving the most life years. So what do I mean there? So the idea that a person who is expected to live five years, do we think about that life differently than a person who's expected to live another 45 years? Intuitively, I think many people would say, oh, well, if we have to make that choice, that awful, impossible, choice, we should save the person who is going to live 45 years over the one who's going to live five years. That's getting at this question of saving the most life years, number of total years of life. And so with that, I'll ask you, is there anything else you think ASCO members or the cancer care community or health care institutions should understand about this work in this moment? Is there anything their families and patients you would want to-- is there anything else you'd want them to know about this that we haven't touched on? I mean, I think one really important but really challenging piece about all this is the role of communication, in every sense of the word, that these are absolutely unprecedented times. And these types of decisions, if and when they have to be made, are luckily things that-- the kind of decisions that we don't typically ever have to make. And so if they have to be made, ensuring that oncologists who have the long-standing relationship with patients and families take on a role of communicating with patients and with their families as much as they can to explain why these decisions are being made, and why they have to be made, to ensure that everybody is on the same page I think is really important. What makes this even more difficult is the fact that most hospitals now have visitor policies such that families and caregivers often, if not most times, are not able to be at the bedside of patients, which makes this only that much harder, but makes communication that much more important. I would want to highlight something you just said, because it resonates, at least for me, and I think for many in our in our community. And that is communication. At root, of all of this is dependent and made easier and smoother by high-quality communications. And I would actually extend what you said by pointing out that it also includes discussions about intentions and desires on the part of patients. And this is something we who take care of cancer patients, I think, do try to spend a lot of time on. This discussion is much easier if a patient who does know about a life-limiting prognosis is clear about what they want. Certainly for the whole team, some of the ethical dilemmas might be minimized that way, right? Yeah, I couldn't say that better. That's one thing we try to highlight in the guidelines as well, that we consider advance-care planning and having goals-of-care discussions to be really at the core of clinical oncology practice. And that continues in the setting of this pandemic. And if anything, it's only more important. Well, I think this is really great. I hope that listeners find this discussion intriguing and go and take a more in-depth look at the actual publication. I want to point out that the recommendations that we've been discussing are just one part of ASCO's longstanding commitment to provide information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer throughout their journeys, and also during this COVID-19 pandemic. That is, what we're doing here is not unique to this pandemic moment, even if the acuity of the need is heightened. There are some other resources that you should be aware of, including patient care guidance for oncologists who treat patients with cancer during the COVID-19 pandemic. There are guidances available for practices on how to adjust our policies in response to the virus and, just recently, on how to begin to return to more normal styles of work. There are also updates on federal activities that have been aimed at responding to this crisis. And everybody knows that this has been a very fast-paced time of change. We recently launched the ASCO survey on COVID-19 in Oncology Registry or ASCO Registry. And our goal is to collect data and share insights on how the virus has impacted cancer care, but also cancer patient outcomes throughout the COVID-19 pandemic. And we encourage all oncology practices to participate so that we can gain the largest data set possible, and therefore represent the diverse population of patients and practices around the United States. I want to remind listeners, you can find all of these resources and a whole lot more at ASCO.org. There is also patient-focused information available at Cancer.net. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, you should take the time to give us a rating or review on Apple Podcasts or wherever you might listen. And while you're there, be sure to subscribe so that you never, ever miss an episode. I want to thank Dr. Marron for joining us today. Thank you, Dr. Hudis. It was an absolute pleasure to join you. And lastly, I want to remind you that the ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at Podcast.ASCO.org.

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Ray Page, Past Chair of ASCO’s Clinical Practice Committee and President of the Center for Cancer and Blood Disorders, to discuss the benefit of drug repository programs solely for oral medications that are maintained within a closed system. These programs can play an important role in helping patients afford their treatment and can reduce the financial toll on the cancer care delivery system, provided that important guardrails are implemented to keep these programs safe. Subscribe to the ASCO in Action podcast through iTunes and Google Play.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is an ASCO series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.   My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to join once again Dr. Ray Page. Dr. Page is a past chair of the American Society of Clinical Oncology's Clinical Practice Committee, he is the President of the Center for Cancer and Blood Disorders where he also serves as a medical oncologist and hematologist, and he's a great and good friend of ASCO's.   Earlier this year, ASCO released a position statement on state drug repository programs outlining the society's support for such programs solely for oral medications and provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place.   Today, Dr. Page and I will discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system as a whole. We will discuss the important guardrails that are needed to keep these programs safe. And with that, I want to welcome you, Dr. Page, and thank you for joining me today.   Thank you very much, Cliff, for having me for this conversation today. And I just want to let you know that I have no disclosures for this conversation.   Thanks again for joining us today, it's a real pleasure to talk with you once more. And I want to get to today's subject. First and foremost, what are state drug repository programs? How do they work and what's the purpose?   In its simplest definition, a drug repository program is basically a legal process that allows unused drugs that have been prescribed to patients to be able to be donated and reused rather than thrown away or set aside if it's no longer needed. Its purpose is to offer a practical way to increase access of prescription drugs for patients. And often, this process can offer more timely access to drugs with a negligible financial impact for the patients. And this was a program that has managed at the state level, and it's subject to individual state laws and State Department of Pharmacy rules and procedures.   And these kind of programs are of exceptional importance to cancer patients who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs. And this has all been on the radar of ASCO's State Affiliates Council in recent years where our state society presidents and their executive directors have shared model state legislation to advance these kinds of drug donation programs in their individual states.   So Ray, before we go any further, can you tell me, what does this actually mechanically in practical terms look like at the level of a practice or from the perspective of a patient or a pharmacy? What actually happens physically with product in the context of a repository?   It really varies from practice to practice and state to state, but Cliff, I can tell you that I see this in my own practice absolutely every day in my doctor-patient interaction. And this is really what's gotten me personally intensely interested in pursuing and establishing laws in Texas to allow for pill donation. Because ideally, we would like to have that transaction between the doctor and the patient of being able to get unused drug for those patients where the drug's not used anymore.   And so there's many reasons why in the office, these people don't need the drug anymore. They could have progression of disease that requires new drug, or alternatively, they could have completed their treatment regimens that may have resulted in a cure. But oftentimes there can be interval dosage adjustments due to side effects and toxicities where they just need a new prescription.   And lastly, I just have to mention a little bit about the negative impacts of the pharmacy benefit managers in this world, and I'll refer our listeners to our previous podcast that we did together a few months ago just understanding the global concerns of the PBMs, but however, I'll just say that their drug distribution process oftentimes contributes to the tremendous cancer drug wastage that we have in the United States.   Well, I mean, picking up on that, if readers take a look at ASCO's position statement, they'll see that we identify there the fact that appropriately-implemented drug repository programs can help address some of the cancer drug waste, And if I remember correctly, this was quantified by researchers in New York at Memorial Sloan Kettering Cancer Center. I think they found an estimate of about $3 billion annually.   The question is, exactly what causes this waste? And you alluded to the fact that you see this in your practice as well, but I just want to be really clear and in a practical sense, this waste is that a patient is dispensed-- I'll say, for argument's sake, 60 pills, and has progression of disease or a toxicity-based dosage adjustment and comes back for a routine office visit and still has, for argument's sake, 20 of the pills leftover. And the goal here is to essentially recycle those pills back into the supply, is that right?   That is correct. And so that's the basic mechanism. And as practicing physicians we see this issue all the time, where for the reasons that I explained, there's always unused pills that we don't need anymore. And if there is a mechanism by which we can safely transfer that drug to somebody that can actually use it and need it, there can be substantial positive impact with that for our patients.   And is it only a financial benefit, Ray? Or are there non-financial benefits as well that this repository programs can somewhat mitigate?   Yeah. Well the financial impact of this is huge. The Americans are paying over $61 billion a year in out-of-pocket expenditures for drugs, and drug abandonment can have serious effects on a patient's health leading to hospitalizations, extensive health care cost, and even death. And the British Medical Journal reported an estimated $3 billion in leftover cancer drugs are discarded in the United States every year, and that's truly a tragic impact on our society.   But also, outside of financial, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment, and we've all heard reports about many of these discarded drugs ending up in our water systems. So redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances.   Well thank you for that. I mean, high out-of-pocket expenses have been for a long time a serious concern for us at ASCO, and you've I think touched on how this can help reduce them. My question is, are there any pushbacks from patients or providers with regard to these programs? I mean, I can imagine that there might be some bureaucratic overhead that might represent a challenge for small practices or maybe there's some risk associated with it, but I'm just guessing. Is there any clear objection to these that we should be thinking about and possibly working to mitigate?   In general, in my interactions with my patients, most everyone has negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physicians recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern are just getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs.   And the physicians I think share that same sentiment of the patients, but in addition, physicians have concern and desires and assurances that these donated drugs are indeed safe for re-distribution.   And Ray, is that what the informed consent would allude to? I was sort of wondering when you said informed consent. In a sense, is there anything different in the informed consent versus what would but with any other cytotoxic prescription, for example? I mean, is there really a way to describe the potential risk or the changes in the risk that there might be some loss of purity in a substance or substitutes? Or-- I'm just trying to figure out what the consent really ultimately conveys.   At least through some of the mechanisms that I'm familiar with that we've developed in Texas is basically there's just a disclosure form that the drug that was in possession of the patient, that they just sign a disclosure that they haven't tampered with it, messed with it, they're stored properly, those kind of things to create those assurances. And then the patient's just given a basically informed consent that they're aware that this transaction has been through a patient and outside the pharmacy.   I see. OK. I mean-- so it sounds to me like we're just, in a sense at a societal level, trying to basically make it clear that there's a theoretical risk of some loss of control, but it's, from a practical point of view, not particularly high, right?   Yes. And I think many oncologists across the United States have just had those experiences with patients in the office that maybe don't have the financial resources, they're looking just for access to drugs. And if there's drug that's available that's been donated, a lot of patients seem to have no problem accepting the drug. And again, I mentioned that a lot of the patients generally trust their physicians' recommendations in that transaction.   Well, I just have to say, I'm as you're talking, I'm reflecting on my own practice experience over the decades. And even for old and inexpensive drugs, it always bothered a lot of my patients that they couldn't simply give their inexpensive tamoxifen, for example, or aromatase inhibitors-- generic drugs, for that matter-- to somebody else in need when they no longer could use it. I think they just were offended by the waste. And even apart from the financial aspects that you've so clearly described, there is, I think, a real altruistic desire to use these drugs and not discard them wastefully, and it's nice to see that there may be the opportunity for patients to satisfy that need.   I agree with you, Cliff. I think there is a strong sense of altruism with our patients. Without a doubt, I think patients have extreme difficulty taking a drug that they know that they-- that the cost of that-- monthly cost of that drug was, say, $12,000 or $16,000, and that they're forced to discard it or flush it in the toilet or turn it in without it being potentially used by somebody else that may be in need, because they've certainly been in those shoes and experienced that themselves.   As you know, ASCO strongly supports repository programs, but we're very focused on oral medications, and we make the assumption that they will be maintained within a closed system. For our listeners, can you describe the difference between a closed system and open system and why we would be favoring a closed system? What makes it safer?   So Cliff, to define a closed system versus an open system, a closed system is a way to have the spirit of having an overabundance of precaution to assure patient safety. And basically, that allows for drugs that are prescribed to a patient and they bring back in that they have appropriate disclosure and supervision, and those drugs are reviewed by a pharmacist and assured that they're safe and able to be recycled according to state laws and pharmacy board rules.   And that's as opposed to an open system where, say, you have a patient that comes into the office and they got a bottle of pills that are unused and they give them to the physician, and then the physician turns around and redistributes those drugs to the next patient who's in need.   I think for many listeners, and probably for even more of our patients nowadays, when they think of cancer treatment, many people are used to thinking about perennial therapies, infusions and the like. But this is really focused obviously on oral medications. What are some of the oral treatments that have been made available? You indirectly alluded to some in terms of price, but what are some of the specific ones that have been successfully made available to patients through drug repository programs so far?   Great question, Cliff. I'll just emphasize it today. Over 40% of cancer therapies that oncologists prescribed are oral drugs, and we have several hundred experimental oral cancer drug that are in clinical trials. So it's anticipated that as time goes on in the future, we're going to be prescribing more and more oral cancer therapies rather than patients spending all day in a chemo chair getting IV infusions. And that's a great thing for our patients.   But currently, I estimate that there's probably over 100 oral anti-cancer drugs and supportive care drugs that are being prescribed to our patients, and these encompass a wide range of treatments, including your classic cytotoxic chemotherapy pills, hormonal agents, molecularly-targeted drugs, and symptom management drugs. And so each state has a drug repository program, has its own pharmacy rules for that redistribution. And in general, most of these drugs, in order to be available, must be in untampered and in secure packaging such as blister packs.   And so most states require inspection by a pharmacist, and therefore, there's a number of great drugs that may not be readily available for redistribution based on state laws and pharmacy rules that are designed to protect patient safety.   Are there other safeguards or any other provisions you think that state drug repository programs could take advantage of to improve their ability to serve patients? Is there anything else we should be doing, you think, as we gain experience with these programs?   You know, Cliff, I'm very pleased that ASCO came out with this position statement in support of the drug depository program that are being developed by each state. And ASCO has provided a few guiding principles for states to consider in their programs, and I think the ASCO recommendations for redistribution in a closed system is in the spirit of an abundance of precaution to assure patient safety.   However, like I said, this can potentially reduce the availability, but ASCO has made some recommendations to the states to where they want to assure that if they're not in a closed system, that the state and federal legislative address the concerns of drug related redistribution that are not in a closed system, that the surplus medications are administered in a safe, effective, and private manner in accordance with the prescribing clinician's guidance.   And the state should have a liability protection in accordance with their state health regulatory authority, and that includes such things as the informed consent and disclosures that we talked about. And then ASCO and other professional medical organizations should continue to make efforts to educate physicians about the existence and the value of these programs, and then ASCO also suggests that this drug repository program should be implemented and no additional cost, or at least as a negligible cost to the patient.   Ray, I think that's great, and I actually, personally and on behalf of the membership and our whole community, applaud you for your activism in this area. Is there anything else that you haven't said that you would want our listeners to know about or have we pretty much covered it all?   Yeah, Cliff, I think there is just a couple of closing thoughts that I want to convey to you. So first, most states allow the redistribution of pills and blister packs, but not pills that are partially used in bottles as we've discussed. But during the last couple of years and again today, I want to implore to the pharmaceutical manufacturers to package their new, often very expensive anticancer drugs in blister packs.   So studies have shown that packaging in this way usually results in improved patient safety and compliance with taking their pills, but most importantly, if for whatever reason those pills are not needed anymore by the patient, the patient or the prescribing institution can donate those pills for redistribution to a fellow patient with a similar cancer. So it's the right thing to do.   And lastly, most states have some form of drug repository program already in their laws; however, unfortunately, most states do not have the program properly turned on. A few states, such as Iowa and Wyoming and Oklahoma, have successful programs working for the patients, but some states have rudimentary programs that need expansion. And then many states need to update their laws and get their programs working again, and this is not an easy process by any means.   I've been working for many years to get a meaningful Texas law passed, which although not perfect, we got a law passed in 2017. And in Texas in the last couple of years, we have been working on the rules and the forms and the processes, and I'm proud to say that my cancer center in Fort Worth is the first registered provider in the state of Texas, and we are currently working with the University of North Texas Health Science Center School of Pharmacy on this, and we've been collecting donated drugs, and we hope that very soon we'll be the first provider in Texas to re-distribute cancer drugs in the state of Texas.   So again, this is not an easy process, but I encourage all states to dust off and modernize their laws to allow cancer patients the ability to get affordable access to drugs through such opportunities as the drug repository program.   Ray, again, I just have to emphasize how deeply grateful I am and I'm so happy to see that you've taken this on and with so much passion. It is hard to understand an argument against this, and that doesn't make it easy, but it's good to be right and it's good to see the effort that you've put into this and to start to see this success. It really does matter to patients as we have been discussing.   So for those of you who want to read more about this, I encourage you to open up ASCO's position statement on drug repository programs. Also there you can find breaking cancer policy news and more, all of that at ASCO in Action. That's on the website at asco.org/ascoaction, remembering that ascoaction is written here as one word.   And until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, we'd love it if you'd give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss another episode. The ASCO in Action podcast is just one of ASCO's as many podcasts. You can find all of the programs at podcast.asco.org.

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis provides an update on a new initiative, the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry), which aims to help the cancer community learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes. “We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve. In times of crisis, it’s especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care,” said Dr. Hudis. Subscribe to the ASCO in Action podcast through iTunes or Google Play.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement.   Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action Podcast is ASCO's Podcast Series, where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.   My name is Dr. Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast Series. For today's podcast, I want to provide a quick update on one of ASCO's his newest initiatives, the ASCO Survey on COVID-19 and Oncology Registry, which we've launched in response to the COVID-19 pandemic.   Now, it is clear that the COVID-19 pandemic poses a unique threat to people all across the globe. Since the worldwide outbreak of the coronavirus, we've learned that some populations, including people with cancer, are even more likely to have worse outcomes and be especially vulnerable to COVID-19. However, there is still a lot that we do not understand, and we have an urgent need to learn more about how COVID-19 is directly and indirectly affecting people with cancer who are the people we serve.   In response, ASCO recently announced the new ASCO survey on COVID-19 and Oncology Registry, or ASCO Registry, for short. This new initiative was developed under the leadership and vision of ASCO's chief medical officer, Dr. Richard Schilsky, with support from a dedicated team of professional staff who work with him in our Center for Research Analytics, also known as CENTRA. The ASCO Registry was established so that we can learn more about the pattern of symptoms and the severity of COVID-19 among patients with cancer.   We also want to learn how the is impacting the delivery of cancer care, and what it is doing to patient outcomes. We're not just looking at a point in time for these patients either. The ASCO Registry instead will capture longitudinal data on how the virus impacts patient care and outcomes throughout the COVID-19 pandemic and into 2021. We hope that this longer term look will tell us if the virus resulted in specific complications for patients, if it delayed patient's ability to get specific types of care or treatment, and if specific certain approaches resulted in better outcomes for patients.   Once we have sufficient data in the registry, we plan to release periodic reports to the cancer community, as well as to the broader public summarizing our key learnings. These reports might include details, like the characteristics of patients with cancer most impacted by COVID-19, estimates of the severity of the disease among patients with cancer, changes or delays in their treatment, and the implementation of telehealth in the cancer care setting. We also hope to be able to report on the clinical outcomes seen among patients with cancer throughout the pandemic, and we might even learn that certain unconventional approaches could allow us to deliver care more efficiently or safely in the future without jeopardizing patient outcomes.   The ASCO Registry is now open to all US oncology practices. This includes physician owned, academic, hospital, or health system own practices, as well as hospitals themselves. Participating practices will be asked to complete a baseline data capture form on each patient with cancer who also has a confirmed case of COVID-19.   Later, these practices will then be asked to provide follow-up information on each patient's status, treatment, and outcomes. The data will be collected on practice level changes, such as new screening procedures, implementation of telehealth in the practice, and changes to the clinical trial enrollment procedures. The ASCO Registry will securely collect limited patient identifying data. This might include zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities. But by collecting this type of data, it will then be possible for us to conduct longitudinal analysis.   Data from practices that participate in the registry will be collected and securely stored in the CancerLinQ platform. We're not alone in our work to better understand the impact of COVID-19 on cancer care and on the patients who we serve. There are other registries including, the COVID-19 and Cancer Consortium or CCC19 and the American Society of Hematology Research Collaborative COVID-19 REGISTRY for Hematologic Malignancy.   The ASH Registry, as well as CCC19 Registry have already been launched, and there are other multi-site registries in development. We're encouraging all oncology practices to participate in one or more of these registries based on their specific needs and based on the patients they serve. Each of these registries has a different focus and a different timeline, so participating in multiple registries will not compromise our efforts, nor will it prevent the organizations involved from working together. We're actively looking for opportunities to collaborate with our colleagues on these initiatives.   The ASCO Registry is part of our ongoing efforts to provide the most current information and resources on the virus to our members and to the larger oncology community. We've developed a wide variety of COVID-19 resources to support clinicians, the cancer care delivery team, and patients with cancer. Some of these resources include, patient care guidance for oncologists who are treating patients with cancer during the COVID-19 pandemic, they also include guidance for practices on how our adjust policies and procedures in response to the virus, and finally, they include updates on federal activities that are responsive to the crisis.   At the same time, we are co-hosting a weekly webinar series with the Oncology Nursing Society, or ONS, on COVID-19. Each of these webinars examines a range of issues and are designed to help clinicians care for people with cancer during the pandemic. You can find all of these resources and more at asco.org. In addition, there are patient focused resources available at cancer.net.   So as we conclude, I want to again invite all of our listeners to learn more about the ASCO Registry by going to asco.org on the web. In times of crisis, it is especially important that we learn from every patient so that we can refine our approaches and continue to deliver the highest quality of care come what may. So until next time, I want to thank you for listening to this ASCO in Action Podcast.   And if you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts, or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action Podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org.

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jason Westin, member of the Government Relations Committee of the Association of Clinical Oncology, to discuss CAR T-cell therapy, a groundbreaking and lifesaving cancer treatment that comes with significant side effects, a jaw-dropping price tag, and limited locations where treatment is currently available. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Welcome to the ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series where we explore the policy and practice issues that impact oncologists, the entire cancer-care deliver team and the individuals we care for--people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For this podcast I am really pleased to have Dr. Jason Westin as my guest. Dr. Westin is a member of the Association for Clinical Oncology's Government Relations Committee. And he is the director of lymphoma clinical research in the Department of Lymphoma Melanoma within the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. Today Dr. Westin and I will discuss chimeric antigen receptor, or CAR T cell therapy. Two years ago, ASCO named CAR T cell therapy as our advance of the year in our annual Clinical Cancer Advances Report. CAR T is a groundbreaking and life-saving treatment for children and young adults with acute lymphoblastic leukemia, and also for adults with diffuse large B cell lymphoma. But it comes with serious side effects, an extraordinary price tag and a limited number of places--at least in the United States--where the treatment is currently available. Today Dr. Westin and I will discuss the current state of the science on CAR T cell therapy, as well as access issues that are facing those patients who are seeking treatment with this new modality. Welcome, Dr. Westin, and thank you for joining me today. Thank you for having me. Before we begin, I'd like to disclose that I have clinical trial funding disclosures that are listed on the ASCO conflict of interest website. Those that I view to be specifically relevant for today's discussion include advisory work as well as clinical trial research funding for CAR T cell companies including Kite/Gilead, Novartis and Juno. I also do clinical trial work with Celgene, Genentech, AB V, Amgen, MorphoSys, Curis, and 47 Inc. Thank you very much for that. We appreciate that. Let's get into the real focus of our conversation today. And let's start, of course, with CAR T cell therapy. What is it, for those who might not be familiar? How would you describe it? And further, what makes it so potentially transformative in oncology? CAR T cell therapy is an incredible breakthrough for our patients fighting cancer. The word car--c a r--stands for chimeric antigen receptor. What a CAR T cell is taking a T cell that's functional and in the body to fight infections, infusing a new receptor on the outside, often a receptor that has an antibody fragment fused to parts of a T cell receptor that now allow this car T cell to recognize the wolf in sheep's clothing that's the cancer. CAR T cells are usually modified genetically using a virus to introduce new DNA into the patient's T cell. And these are prepared in the lab, modified in a way that these can now recognize a surface marker, and then these cells are re-infused into the patient, where they can now grow. They can now find the cancer, and they can destroy it This has been potentially transformative because it is something that has completely different resistance mechanisms than standard chemotherapy. CAR T cells have shown incredible promise in clinical trials and now in early days standard of care. And the sky is the limit for how this could be used in the future, targeting other markers on other types of cancer and really opening up a whole new field of how we treat cancer, much in the way that immunotherapy with checkpoint antibodies has done over the past decade or so. Well, that's exciting. But you just hinted at what I think is the obvious next question. Breakthrough though this may be, clearly this has, at least for some patients, fairly significant side effects. And some of them, I understand, are somewhat different from what an earlier generation of oncologists might have been trained to recognize and to treat. Can you talk a little bit about what some of those side effects are, typically at least? And how we hope to limit that in the future? CAR T cell side effects are certainly unique and not overlapping in the way that we think of oncology therapies side effects. The CAR T cell therapy side effects in the short term are broken down into two main camps. The first is something called cytokine release syndrome, sometimes abbreviated CRS. Cytokine release syndrome is effectively almost like sepsis, in that it's an overwhelming immune response where the T cells that have been manufactured and infused into the patient release an avalanche of cytokines to effectively recruit other immune cells to come help fight the cancer. And in doing so, induces sepsis-like phenomenon of organ dysfunction, fever, and sometimes hypertension, which can be severe. The other acute short-term side effect that we can see from CAR T cell therapy is a significant neurologic toxicity. And this is a new diagnosis, a new syndrome that's recently been classified by a consensus group as immune effector cell associated neurologic syndrome, or icans, for short. This can range from mild slowing of speech or mild slowing of cognition all the way to status epilepticus and anything in between. The most common troubles folks have are mild slowing, but aphasias and/or seizures can certainly occur and can be quite distressing to the patient and to the family. Thankfully it seems that both cytokine release syndrome and icans, the neurologic toxicity, appear to be fully reversible in the nearly all patients, in the vast majority of patients. The late side effects of CAR T cells are also unique and different from what we've seen from prior chemotherapy-type induced side effects. These include, depending upon what target you're going after, an effective lack of the target expression long term. And for CD 19 focusing therapies, this effectively means a B cell aplasia that can sometimes be for a year or longer after the one infusion of car T cells are administered. We know from other immune therapies that depleting certain parts of the immune system is not usually overwhelming infections or other obvious toxicities, but can result in chronic infections, inflammation and need for replacement of things like intravenous immunoglobulin to replace immunoglobulin deficiency. So CAR T cell side effects are not what we typically think of in terms of chemotherapy, of cytopenias, nausea and fatigue, or immune therapies of inflammatory responses off target from the projected cancer. These are more specific toxicities related to the extreme expansion and cytokine release of these Car T cells during the battle against cancer as well as lingering effects from these T cells remaining active for many months and maybe even years after the infusion. There are a number of barriers right now. You've highlighted some of them. First of all, we don't have applicability yet established for a large number of diseases. That's an area for research. There are special toxicities. And it sounds like, realistically, anybody starting to do this needs to be trained and needs support staff and teams, just like you described. So there's a geographic limitation. But beyond all of that, there's also a more conventional limitation, which is just outright cost. And as I understand it, the cost, or at least the list price for available agents, can range from $373,000 to treat an adult with an advanced lymphoma up to 475 to treat a pediatric indication. And further, I think these prices do not include the additional costs of hospitalization or managing side effects, and maybe other adverse events. I'm curious, do these prices matter day to day in your practice? Do your patients need assistance navigating this? Or what's the real-world experience, given this price point? This is a major concern for us for the future of CAR T cell therapy. The accessibility not just based on physically being able to get it but financially being able to get these therapies, as you mentioned. The cost of the actual product itself, the one-time infusion of these T cells that are manufactured specifically for each given patient, it's a major cost. But in addition to that, the actual hospitalization, which is usually a significant amount of time. For most patients that receive CAR T cell, they're hospitalized between a week to 10 days. This is not a trivial admission for observation overnight in the hospital. These are huge costs. Now payers, including commercial and private payers, and now government payers, are supporting this. However, as the number of patients grow, this is going to be something that's going to increasingly strain the ability of the system to support an incredibly expensive therapy. This is potentially home-run therapy for patients that may, in some cases, have decades of life left to go. So, the cost is not trivial for the benefit received. But it is an incredible amount that's put upon the system, put upon the payers. Right now, through payers, it's doable. But I worry about the future of this as the number of patients who can benefit from this goes up. Well, I guess if it's as transformative as you're describing, it is at least plausible that it's front-loading costs, but net actually might not be particularly more expensive than traditional, long-standing, less-effective therapies. I assume those kinds of economic models and reports are being developed. Is there anything you can say about that at this point? Or is it just too soon to make those estimates? It's still very early days. But there are absolutely analyses being done, at looking at the number of quality life years gained from these kind of treatments. And depending upon the effectiveness of the treatment, it can absolutely be a net long-term positive of somebody getting back to health and not requiring chronic therapies, or not dying at a premature age. So, there is no doubt that the cost of this is high, but the benefit is also very high. But if this continues long term to scale up for more and more patients, even net long-term success and long-term neutrality of a cost, if you're paying more now and getting less costs later, it can still strain the system, if the upfront cost is substantial. So, I think this is something that's going to have to be looked at in terms of, what is the true cost of making CAR T cells? And potentially bringing those costs down as we try to scale up for more patients over time. So, you spoke about getting approval, and it sounded like you were talking about conventional commercial payers. Last year, the Centers for Medicare and Medicaid Services, or CMS, announced that Medicare would cover CAR T nationwide and we at ASCO were really delighted with that. But we recognize that, while the drugs are being reimbursed, that reimbursement remains at a level well below the actual acquisition costs. So, I think this is another version of the same question, but how is that shortfall impacting patients? And how is it addressed? Or is that just something that the institutions have to eat? It's different from different institutions, depending upon their status with CMS and if they're grandfathered into older systems, or if they're not protected in that way, it is certainly a problem. And it's something that the approval for this to be funded by CMS was absolutely great for our patients. However, the reimbursement, as you mentioned, that's proposed for that approval is quite low. It's not close to the price for the product as well as for the inpatient stay. And so many hospitals are treating commercial patients with the idea that they are reimbursed at a higher level to cover patients who are treated and covered by government payer systems. The government payer systems also have temporary funding that's associated with the new technology, the end-tap mechanism, where there's an initial bump in the reimbursement that's not permanent. This is--these add-on payments are helping hospitals who are at risk of having a net loss financially for doing CAR T cells. But these are only usually two years in length, meaning that this is not going to be a cost assistance for those hospitals for the long future of CAR T cells. This is short term. So, this is something that is new to government payers. This took quite a while after approval for CMS to make a determination on where this would be supported or not. It's all brand new. And it takes time to figure out the potential benefit, the potential long-term reimbursement levels. But the current reimbursement levels are not going to be sustainable from government payers to hospitals, as a modality to keep this viable therapy for patients. We've already seen some hospitals that are not able or willing to treat patients who are on a government health-care system, actually sending them to larger systems that are treating many commercial patients to try and subsidize this net loss for a patient on Medicare or Medicaid. This is something that is a big problem that's in addition to the cost of it. The substandard reimbursement is going to be a strain on the system in the long run. Well, that's interesting. I mean before the CMS coverage announcement came out, we at ASCO actually submitted comments to the agency, and this included our perspective on both appropriate coverage and reimbursement for CAR T as well as an overarching description of ASCO's principles on approval coverage and getting the right treatment to the right patients at the right time. That's really the underlying principle that we try to rely on. I mention that because I know you have some familiarity with policy making in government, and then you've been--we've been--lucky, I think, that you're serving on the government relations committee right now. From the perspective of that, GRC, I wonder if you care to just expand a little bit on the importance of ASCO coming out and taking a stand on an issue like this. I think it's essential for organizations like ASCO to advocate on behalf of our patients to try and educate policymakers and lawmakers about exciting new breakthroughs and why this matters for our country, as well as for our future. This technology is so new and so innovative. So different than what we've done before in terms of treating diseases with medications or with antibodies, that it is sometimes a shock to the system about what exactly is this CAR T cell. What exactly does that mean? And having lawmakers and policymakers learn from organizations of experts like ASCO. And having policy statements and comments made on potential proposed recommendations. If we don't speak up for our patients, then our patients are going to suffer. And so, I applaud ASCO and the team at ASCO that works on these recommendations and policy statements. Because this really is essential for us to speak up and to be seated at the table in a way that we can advocate for our patients. It's sometimes difficult for lawmakers or for policymakers to know what to prioritize. Or if this is something that's real, or if this sounds too good to be true, and therefore we shouldn't learn much about it or pay attention to it. As mentioned earlier on this podcast, this is the beginning of a new era of therapy for fighting cancer. And we need to make sure that our policymakers and our lawmakers are aware this is coming, and aware that this is something that's going to be potentially transformative. And therefore, legislating and making policy in a way to allow patients dealing with cancer to have access to these incredible new treatments. So, on the question, again, of access, maybe going in a slightly different direction. We've talked a good bit just now about the science. We've talked a little bit about the toxicities. And we've spoken about the geographic limitations as well as payment. But addressing the geography issue. Obviously with scale and familiarity, it's at least conceivable that more centers could offer this, and they might offer it on an entirely outpatient basis. What do you think about that as a near-term potential? And what do you think we have to maybe accomplish? What advances might be needed in order to facilitate that? Or you could say, I guess, not going to happen. So, what do you think is coming in that regard? I think that the CAR T cell delivery has such a special need for both monitoring as well as anticipation of management of troubles, that this is not something that I see the current generation of CAR T cells being administered widely in settings that don't have experience with this, or settings that don't have experience with prior transplant-type treatments. This is treatment which has potential danger to go sideways in a hurry. And if you've never done this before, you may not anticipate that, and not be able to help your patients. So, there are current geographic limitations, and centers that do this and centers that don't. And I think that's probably for good reasons at this point and should not be something that we try and break down those walls and have this available at every oncology clinic until we work out ways to make this safer and less dangerous. So, it's been a significant challenge to try to transition the current generation of CAR T cells from an inpatient setting to outpatient setting. We are working on that, as others are. And there are some CAR T cell products that may lend themselves to easier use as an outpatient, either because of less toxicities or less severe toxicities projected.  So, this is not something that's going to be a forever problem. But to the current generation of the FDA-approved products, the vast majority are administered inpatient, which is a strain on the hospital systems as well as on patients who prefer not to be cooped up in the hospital for a week to 10 days, if they don't need to be. So, I think this will change as we get better technology, as we get systems in place to monitor patients through telemedicine system as an outpatient. And hospitals have more direct lines from the hotel to the inpatient service, if you have a toxicity. That's coming, but it's been a challenge. I think that's a great place for us to start to wrap this up. I have to ask though, reflecting on what we've covered, is there any area of CAR T science or clinical use that we've neglected to surface in this conversation? Or anything else you want to convey to the listeners? I think the CAR T cell story is an incredible advance. When I describe it to my patients, I describe it as almost a science fiction-like therapy where we're able to take your immune system, modify it in a way that it can now see the wolf in sheep's clothing, and get back and re-infuse these cells back in your body. And get them to work to effectively eliminate the cancer that they've not been able to do thus far. This is a therapy that works incredibly well for relatively rare cancers at this point. And so I think, as we're smarter and as we learn how to better manipulate the immune system in therapeutic ways, the sky is the limit for how we can both treat cancers and hopefully, even as we get further afield, maybe even prevent cancers from ever developing. If we know somebody has a genetic risk that is a high probability of developing a cancer, teaching their immune system new tricks, so that we can have the sky be the limit and really work to try to end cancer, to try and conquer cancer. This is something that is obviously a goal for many researchers and many people who focus on cancer. But this new advance of cell therapy, of CAR T cell therapy, is a major step forward in our efforts to try and rid the world of cancer. Well, I mean that's just a great way to wrap this up, I think. And I want to again thank you, Dr. Westin for taking the time to speak with me today and for providing so much clear and understandable information. I'm sure this will be useful for a lot of people. Really appreciate it. Thank you very much for having me. And I do hope that all of our listeners have enjoyed this conversation on CAR T cell therapy, an exciting and developing area of cancer care. I hope you also see, woven through this, the way in which we are able to take evidence-based advocacy to policymakers to support the kinds of cutting-edge, scientific advances that are members and all of our listeners contributed to through their research and their study. And I think that this is something that highlights the connected nature, again, of all of our work and the importance of our engagement. For those of you who want to learn more about CAR T and also breaking cancer policy news, we have that for you at ASCO in action on our website. And again, as a reminder, that's ASCO.org/ASCOaction. And in this case, ASCO action is all one word. Until next time, I want to thank everyone for listening to this ASCO in Action podcast. If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple podcasts or wherever you listen. And while you're there, please make sure you subscribe, so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of our shows at podcast.asco.org.

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by ASCO Chief Medical Officer Dr. Richard Schilsky to discuss the recently released 2020 Clinical Cancer Advances report, which named the refinement of surgical treatments for cancer as the Advance of the Year.  “A lot of the advances we’re seeing in surgical approaches now are driven by better systemic therapies for cancer. These systemic treatments have improved survival outcomes and quality of life for our patients, and have now begun to transform the role of surgery in cancer management by reducing the amount of surgery in some cases, eliminating the need for it in others, or, conversely, increasing the number of patients who could undergo surgery when it’s needed for treatment of their cancer,” says Dr. Schilsky.   Subscribe to the ASCO in Action podcast through iTunes and Google Play.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this series, and I'm delighted today to have as my guest the Society's Chief Medical Officer and Executive Vice President, Dr. Richard Schilsky. He's also an executive editor for the recently released 2020 Clinical Cancer Advances Report. In this report, ASCO identifies the most important clinical research advances of the past year across the full trajectory of the disease, from prevention and screening, to treatment and survivorship. The report also announces ASCO's Advance of the Year and updates our list of research priorities that have great potential to accelerate progress against cancer. Rich, welcome, and thank you for joining me today.  Thanks a lot, Cliff.  Now, starting at the beginning, this year ASCO has recognized refinement of surgical treatment of cancer as the Advance of the Year, and this is an area of clinical cancer research that has demonstrated the most significant progress in a year's time. I have to say, before we get into that, it seems almost poetic to me that this has happened this year because, one, we lost a leading surgical investigator in our field, Bernie Fisher, this year, and two, as I think about it, it came as a little bit of a surprise to me only because the mid 19th century was really the beginning of the century of surgery, and surgery for cancer dates back to Roman and Greek times, actually. So, can you tell us, in light of all of that, what was it that brought this back to the fore this year?  Over the years, we've seen a great deal of progress in developing the new systemic therapies for cancer, and this really, I think, illustrates the prescient work of Bernie Fisher in his seminal research on adjuvant therapy for breast cancer, because a lot of the advances that we're seeing in surgical approaches now are driven by better systemic therapies for cancer. These treatments have improved survival outcomes and quality of life for our patients, and they've now begun to transform the role of surgery in cancer management by reducing the amounts of surgery in some cases, and even eliminating the need for it in others. Or conversely, increasing the number of patients who can undergo surgery when, in fact, it is needed to help in the treatment of their cancer.  That's great to hear, because I was wondering at first if it was simply the fact that we just had a president who was a surgeon, and it's clearly about much more than that. What are some are the specific advances that you actually would cite as supporting this call out of surgery this year?  Yeah, I think there some really interesting reports that are summarized in this year's Clinical Cancer Advances that really speak to this issue. In melanoma, for example, there are two studies that examine the efficacy and safety of neoadjuvant treatments for patients with locally advanced disease. Australian researchers examined the combination of two molecularly targeted drugs, dabrafenib and trametinib, given before surgery in patients with stage 3c melanoma that has BRAF V600 mutation. Not only did 86% of patients on the trial respond by the time of resection, but almost half had a complete response, either obviating the need for or simplifying the surgical treatment.  In another study, patients with stage three melanoma that was still treatable with surgery received ipilimumab and nivolumab for two cycles prior to surgery, resulting in a pathologic response rate of 77%. These studies are already changing practice, helping patients with locally advanced melanoma avoid surgery in many cases, or making surgery possible in patients with locally advanced disease who might not otherwise have been candidates for surgical resection. So this really is the year, I think, where we're seeing highly effective systemic therapies making surgery more possible where surgery can contribute to achieving better cure rates, or obviating the need for surgery where surgery is actually no longer necessary given the effectiveness of systemic treatment.  From your point of view, as you look at both our Clinical Cancer Advances for this year and also the totality of public health data, what role would you ascribe to federal funding in generating these advances?  Well, I think it's pretty clear that essentially every cancer advance begins in the basic science laboratory. It begins with new discovery, new understanding of biology, new description of mechanism of cancer progression, and the identification of novel cancer targets, and all of that basic research that's funded by NCI and NIH more broadly is the foundation for all the progress that we've made in development of new therapies, as well as prevention strategies and early detection strategies and so on. So, the federal funding is critical.   This year's Clinical Cancer Advances Report highlights 10 studies that were supported, directly or in part, by funding from the NIH, so that highlights another important role for the federal funding. Not only is there the discovery work, but there is also the work through NCI-funded cooperative group studies and other clinical trials that actually is helping to translate those basic science discoveries into clinical trials, and more importantly, helping to design clinical trials that are not likely to be pursued by commercial interests, but that answer important clinical questions that directly impact the way patients are treated by their physicians.  This is the second year that ASCO has included with its Clinical Cancer Advances Report a specific set of research priorities. Can you tell us a little bit about the motivation for creating this so-called research agenda for the country, and then the criteria that are used to select these specific priorities?  Well, as you said, as much progress as we're making, there still is substantial unmet need, and so we need to continue to accelerate progress in many areas and focus our resources, so we launched ASCO's list of research priorities to accelerate progress against cancer by sparking momentum in those areas of research where the opportunity is really ripe to spur new advances. The goal in doing this is to provide the cancer community with direction, or at least insight as to where to focus their investments and resources. The research priorities represent areas that have the potential to significantly improve the knowledge base for clinical decision-making and help us address vital needs in cancer care that remain unfulfilled.  Now, these priorities are nominated by ASCO volunteers and clinical experts who've worked on the Clinical Cancer Advances Report and have identified not only what the big advances are for the year, but what the unmet needs are, where the opportunities still lie to continue to accelerate our research momentum. So, they were then discussed and distilled and evaluated by various groups of ASCO experts, and what's now in the report represents our best current thinking about where we have opportunities to really have a big impact.  And I think, if I'm not mistaken, one of the hopes for results of this is to recognize that there are areas that get a lot of research. We know there are literally more than 100 I-O drugs theoretically in development right now around the world. Our goal here, I think, is to highlight some of the areas that may not be supported directly by industry necessarily, but in fact, may be dismissed as people think about high-impact targets. There are some places where we need to make progress in order to offer the most patients the greatest benefit.  I think the research priorities are not necessarily what might be thought of as underrepresented areas of research, but they are areas where ASCO feels that there is opportunity to have a big impact, because there's already sort of a glimmer of progress being made in these areas, and we believe that with further investment and prioritization, we can really much more rapidly accelerate progress in these areas. And the research priorities are by intention fairly broadly stated, because we're talking in the research priorities not necessarily about a specific disease or a specific target, but really a specific approach or an area where we believe we can have broad impact by focusing on a specific population or a way in which we can use therapy more effectively or with less toxicity.  So as an example, and just making it up, but a difficult to treat disease where there is not, again, meaningful scientific advance actually wouldn't make the list because there's not really an opportunity right now in our minds, right?  Absolutely. And in fact, when you look at the list, you'll see that there are no specific cancers that are called out in the list. The list is really about specific populations, specific approaches, ways in which we can better utilize available therapies or limit the toxicities of available therapies so that overall, the impact of treatment is greater for the particular patient population.  So then why don't we just dive right in and talk about what are some of the research priorities that made the list this year.  There are eight priorities this year. They really fall into three major thematic areas. The first of those is getting treatments to the patients who can benefit from them the most and sparing the toxicities and costs of treatment for the patients who would benefit the least. So, two priorities in that area are identifying strategies that predict response and resistance to immunotherapies.  So these are therapies that we already know can have an enduring impact on a small proportion of patients across a variety of different diseases, and the real question is, who are the patients who are likely to receive that long-term benefit, and who are the patients who are unlikely to benefit and understand why, but also if the patients are not going to benefit from those therapies to then turn to alternative treatments with fewer toxicities. Another priority in this area that sort of echoes of the advance of the year is to further understand how to limit the expensive surgery by optimizing systemic therapy, and this really gets back to the whole concept of adjuvant therapy in many ways, where we know that many patients who receive adjuvant therapy either don't need it or don't benefit from it. And what we want to be able to do is to tailor adjuvant therapy in such a way that it has the greatest impact on the population that needs it the most.  Now, the priorities are also focusing on improving treatment and care of special populations, emphasizing the importance of improving representation of these populations with clinical trials so that we actually have reliable data to better inform treatment approaches. A few priorities in this thematic area include increasing precision medicine research and treatment approaches in pediatric and other rare cancers, optimizing care for older adults with cancer, increasing equitable access to cancer clinical trials so that more patients can benefit from those studies, and importantly, reducing the adverse consequences of cancer treatment, particularly in long-term survivors who, in a sense, have to live with the consequences of their cancer and its treatment for the rest of their lives.  Finally, but not least, the research priorities focus on reducing the risk of cancer and on detecting it early. So, there is a priority on reducing obesity's impact on cancer incidence and outcomes, I know that's been of particular interest of yours for many years, and then on better identifying premalignant lesions and predicting when treatment is needed. We know from the natural history of many premalignant cancers that they never will evolve to invasive cancer, and so there's a risk of over-treating people based on a diagnosis of a pretty invasive cancer. We want to better understand the biology and natural history of those circumstances so that the patients who need treatment will get it and the patients who can safely forgo it can skip it.  Yeah, and one can imagine in the years ahead that that will actually, if you will, leap into even low-grade, but invasive cancers and start to help us know who actually needs therapy and you can just have a cancer--  Yeah, I'm sure you could do many hours of podcasting about DCIS and the controversy surrounding that type of cancer. Of course, the same is true in prostate cancer and other cancers that have a diverse natural history. There are clearly circumstances where patients who have early stage, but biologically indolent cancer may not need treatment or may not need aggressive treatment. We just have to be able to identify who those patients are.  Right. So, for people who are intrigued by this, and I hope you are, I encourage you to take a look at the full and detailed list of the research agenda by visiting asco.org/cca. That's asco.org/cca, and there, you can take a deeper dive into all of these items. Now, Rich, if we were to succeed and direct the right resources to these priority areas, how would you see this actually transforming patient care in the next few years?  Well, at a high level, I think it's-- we hope it'll dramatically change the care of cancer patients and allow more patients to get the right treatment at the right time, and of course, enabling them to live longer, fuller, better lives. It's really all about understanding the biology of each person's cancer, its likely natural history, its vulnerabilities, and then developing a treatment plan that is optimized for the care of that particular individual.  Now, we recognize-- and we touched on this already-- that we can't do all of this within ASCO, and we don't have the ability to specifically direct research programs. So, what is it that would satisfy us that the cancer community is responding to this goading, if you will, and is trying to make progress? What would be the indicators that you would find?  Well, as you said earlier, I mean, we continue to vigorously advocate for increasing federal funding for cancer research, which is the foundation of all the basic science breakthroughs that enable everything that flows from that in terms of development of new molecular diagnostics and treatments, so we want to continue to be aggressive in advocating for that improved funding. We clearly still need better prevention and screening approaches. We saw very little in the way-- other than vaccination, as we discussed earlier, and a few drugs, like some of the drugs that are approved to treat or reduce the risk of breast cancer in high-risk individuals, we saw very few effective prevention strategies. We need a lot more research on how to identify what those strategies might be and how to bring them to fruition.  We have a lot of opportunity that can really only be supported through federal funding to do what's often referred to as comparative effectiveness research. The pharmaceutical company's job is to bring new drugs to market, not to necessarily show which drug among many is the best drug for an individual person. And yet, we know that patients and doctors are confronted with these decisions all the time, particularly when there are several approved drugs in a given indication. Which is the best one to use, which is the least toxic, which is the one that's likely to produce the best outcomes for my particular patient? Those are questions that can be answered through comparative effectiveness studies that can be funded by federal funds.  And then finally. Breakthroughs on rare cancers. Rare cancers are not necessarily a focus for commercial drug development because they represent small markets. Now, we are beginning to see with the FDA approval of some histology agnostic drug approvals that even drugs that target very rare molecular alterations can potentially be attractive to the pharmaceutical industry. Because in the histology agnostic approval, it opens up a much broader market. But rare cancers otherwise are likely to not get the attention of commercial developers, and we need federal funding to support research in those areas, to be sure.  So really, our hope with these priorities is that we stimulate the entirety of the research and treatment ecosystem to think about these studies, to support them, design them, and enroll patients on them given the opportunity, right?  Well, that's exactly right. And the whole ecosystem has a role to play in bringing drugs from the discovery phase, through development, through ultimate commercialization, and then the effectiveness research then follows on after the commercialization so we really actually understand how the drugs perform in real-world populations, many of whom never get the opportunity to participate in the pivotal clinical trials.  So fundamentally, this can all be understood as advocacy. And in that regard, I guess it's reasonable, or at least our listeners may wonder what steps they and ASCO members in general can take to urge Congress to support these policies and support the critical cancer research that we're highlighting.  The easiest thing for ASCO members is to contact their members of Congress through ASCO's ACT, A-C-T, Network, which they can access at asco.org/actnetwork, and there, they can easily generate a letter advocating for federal support for cancer research to their congressmen and their senators. And I can't stress enough how important it is that all members get involved in this advocacy work. There are also opportunities for people to come to Washington to participate in ASCO's Hill days and to get involved in ASCO's other activities through the Government Relations Committee and other work that their society is doing on their behalf.  Well, this is great. In just about a half an hour here, we've covered a large amount of material and a lot of progress. Maybe at the risk of some redundancy, what do you think, in summary, is the takeaway that you hope that listeners and everyone reading the Clinical Cancer Advances Report takes away?  It's a bit hard for me to sort of grapple with this from time to time, but I've now been an oncologist for 40 years, and over the 40 years of my career, when you look at it through that broad span of time, I really feel like I've seen remarkable progress that we have made together in understanding cancer biology, developing far more effective and less toxic therapies, developing much better supportive care strategies, and we're now really beginning to see that at the population level with this substantial fall in cancer mortality rates that you alluded to earlier that's been occurring now year over year over year for at least the last two decades. And this year, as you suggested, it's being attributed, at least in part, to far more effective treatments for cancer than we've ever had in the past, particularly for lung cancer, which is still the nation's biggest cancer killer, but for which we have far better therapies than we've ever had before. All of this comes only from a sustained commitment to research, from having an ecosystem, as you suggested earlier, that's committed to making progress in every cancer type for every cancer patient. And I am remarkably optimistic as we now head into a new decade that the pace of progress is going to continue to accelerate in a very unprecedented way.  Yeah, I agree. I mean, it's been interesting to watch the advances I think one of the places where we have to acknowledge frustration on the part of our members and community and the patients we serve is that the advances are often very pointed because of scientific breakthroughs, and they are profound, and meaningful, and they transform disease, but the totality of the burden of cancer remains substantial. For some reasons outside the scope of this discussion, it will even continue to grow on a global level. So, we have a challenge here to celebrate real advances while respecting the fact that we have a lot of progress ahead, right?  Our work's not done, but it's gotten a lot easier, and in many ways, a lot more fulfilling.  Well, Rich, I want to thank you again, both for leading the production of this report, and for joining me today on this ASCO in Action podcast to talk about it. I encourage our listeners, again, to read the full report by visiting asco.org/cca.  Thanks, Cliff. This is really a fun project for me to work on every year with wonderful ASCO volunteers, and I hope our members will enjoy reviewing all the advances summarized in the report this year.  For those of you listening, if you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcast or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.  Dr. Schilsky reports serving on the board of directors for the Reagan-Udall Foundation for FDA and research grants to ASCO in support of a clinical trial from the following companies: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb. Genentech, Lilly, Merck, and Pfizer. 

ASCO CEO Dr. Clifford A. Hudis discusses findings from the ASCO 2019 National Cancer Opinion Survey, which found that only one in four Americans are taking concrete steps to prevent cancer, even though evidence exists that as many as half of all cancer cases are preventable. Further, the survey found that while 6 in 10 adults report being concerned about developing cancer, 25% believe that there is nothing they can do to prevent cancer. The survey also revealed troubling behaviors and attitudes around e-cigarette usage and end-of-life care.   If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org and click on the survey link. Once again, that's podcast.asco.org. This survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Welcome to the ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offer enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. I’m Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. Today, I want to share some very interesting findings from ASCO’s 2019 National Cancer Opinion Survey.  ASCO started doing this annual survey three years ago in collaboration with the Harris Poll so we could track the public’s views on cancer research and care. The poll, supported by the Mission Endowment of ASCO’s Conquer Cancer Foundation, is conducted annually to measure shifts in the public’s perceptions of a range of cancer-related issues over time.  The findings come from a large, nationally representative sample of U.S. adults ages 18 and older that included individuals with cancer.  As the world’s leading organization of oncology professionals who care for people with cancer, ASCO believes it is critical to understand what the public, including patients, think of, expect, and need from the nation’s cancer care system.   So, what did this year’s survey tell us? Well, this year’s findings raise serious concerns about an area of cancer care that—as anyone who treats cancer patients would say—should be uppermost in all our minds, and that is cancer prevention in America. I’ll get into the details in just a moment, but the results tell us that much more education on cancer prevention is needed, beginning at a young age—when it can have the greatest impact.  This year’s survey also tells us that far too many young people regularly use e-cigarettes and believe they are harmless and not addictive. And, a third area the National Cancer Opinion Survey examined is end-of-life care and, here, we found gaps in awareness about the importance of patients discussing end-of-life wishes with their doctors and family members.  So, turning to the area of cancer prevention, the ASCO survey found that only one in four Americans incorporate cancer prevention into their daily lives. When you think about it, this low rate is remarkable since research shows that as many as half of all cancer cases are preventable.  Interestingly, our survey also reported six in 10 adults (57%) are concerned about getting cancer. You might think more than 25% of us would care deeply about cancer prevention and take risk reduction steps every day. So, we’re seeing a disconnect between attitudes and behaviors on this point.  We also found low levels of public awareness of known cancer risk factors such as alcohol and obesity, and misconceptions that artificial sweeteners and cell phones cause cancer in humans. Clearly, this is a larger public health issue and more work needs to be done.  For starters, we urge every American to have regular conversations with their physician about reducing their risk of cancer and other chronic diseases.  As I’m sure most of you know, stories about the use of e-cigarettes—or vaping—have been in the headlines with reported deaths from severe respiratory illness with e-cigarette use. As an organization of cancer doctors, we’re very concerned about the potential for e-cigarettes to become a gateway for youth to use cancer-causing tobacco products and the serious side effects that are beginning to emerge.  So, we wanted to examine this issue more deeply in this year’s National Cancer Opinion Survey and what we found is troubling:  Roughly one in five young adults uses e-cigarettes daily or recreationally, and nearly one in four believes the products are harmless and not addictive. These findings reflect survey responses from Generation Z respondents, who are ages 18 to 22, and Millennials, who are ages 23 to 38.   But, I also want to note that there is also evidence that e-cigarette use among pre-teens and teens is on the rise. Make no mistake, this is very worrisome news. The U.S. Surgeon General has warned that e-cigarettes contain addictive and harmful or potentially harmful ingredients, including nicotine; lead and other heavy metals; and flavorants such as diacetyl, a chemical linked to serious lung disease.  For ASCO’s part, we issued a policy statement with the American Association for Cancer Research which called for putting safety labels with a warning about nicotine addiction on all e-cigarette packaging; prohibiting youth-oriented advertising; and banning the sale of e-cigarettes containing candy or youth-oriented flavors unless there is evidence demonstrating these products do not encourage use of e-cigarettes by youth.  We will continue to monitor this issue closely and keep ASCO members informed of developments.  Finally, I want to touch on a notable survey finding related to end-of-life care. Our survey found that most people affected by cancer aren’t discussing end-of-life care with their doctors, even though they believe it’s important.  As cancer doctors, we understand that it’s critical to plan ahead for end-of-life care in the advanced stages of cancer or any disease. Physicians and patients should discuss all available care options and develop a plan that reflects patients’ wishes and goals. This can ease the emotional and may even reduce the financial burden for patients and their loved ones.  I want our listeners to know that resources for planning for end-of-life care, including a patient booklet, are available at Cancer.Net. I encourage you to take advantage of this free resource.  If you’re interested in learning more about the ASCO National Cancer Opinion Survey, please visit asco.org and search for National Cancer Opinion Survey.  We would like our listeners to know that resources for planning end of life care, including a patient educational booklet, are available at cancer.net. And I would encourage everyone to take a look at this and take advantage of this free resource. I want to close by thanking our audience for taking the time to listen to this overview of our survey findings. At ASCO, the results of this survey will inform our activities as we work to conquer cancer through research, education, and the promotion of the highest quality patient care. If you're interested in learning more about the ASCO National Cancer Opinion Survey, please visit ASCO.org and search for National Cancer Opinion Survey. And if you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcast or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of our shows at podcast.asco.org. So, until next time, thanks again for listening to this ASCO in Action podcast.

Subscribe through iTunes and Google Play. Dr. Melissa Dillmon, the Chair of ASCO's Government Relations Committee, joins ASCO CEO Clifford A. Hudis to discuss improving access to clinical trials for patients with Medicaid. Medicaid covers 20% of Americans, however unlike Medicare or private insurers, Medicaid is not federally required to cover the routine care costs associated with clinical trials.  Find all of ASCO's podcasts at podcast.asco.org Transcription Shannon McKernin: Hi. My name is Shannon McKernin, and I am the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care, at podcast.asco.org. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the individuals who care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series. For today's podcast, I am really delighted to be joined by Dr. Melissa Dillmon-- Missy-- the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer. Now, regular ASCO in Action podcast listeners may remember that just a few months ago, I spoke with one of our colleagues, Dr. Beverly Moy, the issue of financial barriers to clinical trial participation, and we focused on ASCO's work to address those barriers to try to make it easier for patients to enroll in clinical research studies. Today, we're going to follow up on that. Dr. Dillmon is going to join me as we drill down deeper into one of the barriers that we've touched on previously-- in this case, the lack of coverage of routine care costs that are associated with clinical trials, but very specifically, the challenges that are faced by patients who have Medicaid. Dr. Dillmon, welcome, and thank you for joining us today. Melissa Dillmon: Thank you, Cliff, for having me and discussing what I think is a very timely and important issue. Clifford Hudis: Since it's something I know you care deeply about, maybe you could start off at a high level and give us a little bit of background. What is it exactly that we're talking about here, when we talk about clinical research and coverage for patients with Medicaid? Melissa Dillmon: So Cliff, you know that in many cases, clinical trials provide the best or sometimes the only treatment option for our patients with cancer. And we live in a time when there is an incredibly rapid pace of development, with new investigational treatments that are dramatically altering the course of cancer for the better. Patients with Medicaid have a unique barrier to accessing clinical trials because Medicaid is the only payer that is not federally required to cover the routine cost of clinical trial participation. So Medicare and major commercial payers are required to have coverage for routine costs of clinical trial participation. Medicare provided this coverage beginning in the year 2000 after the Medicare National Coverage Determination Act protected their beneficiaries. The Affordable Care Act also requires insurers to cover routine patient care costs for trials participation. But Medicaid was not specifically called out or included in this requirement. So today, commercial payers and Medicare are paying for the routine cost of clinical trial participation, but Medicaid is not required in any of the states by the federal government to cover these costs. And we know that these patients have financial barriers to accessing basic medical care and preventative services anyway. So this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving treatment trials. Clifford Hudis: I remember from, obviously in my days of doing clinical studies, there was often a lot of discussion about what was a routine cost of clinical care and what was a research cost. Can you expand a little bit on which parts of this are covered, or are they all covered, by these requirements? Melissa Dillmon: So routine care costs are the regular doctor's appointment or E&M charge, radiology exams, drugs to manage side effects, supportive care medications, laboratory tests. It is not the cost of the drug or anything specifically related to that, it's just the routine care costs that go along with cancer treatment care, whether that patient was on a trial or on a regular, on-label drug. Clifford Hudis: And in an ideal world, when this is working efficiently, this dovetails neatly with the fact that the non-routine care costs-- those things that are being required only because the participants involved in a very specific research study-- those costs are generally borne by a sponsor, right? Melissa Dillmon: Correct. So perhaps if there is a genomic sequencing that was required, or a special laboratory test to assess a response in a marker that was not a routine care cost, that's usually covered by the sponsor of the clinical trial. Clifford Hudis: And so just to make sure every listener is following, the irony here is without this requirement, in a sense, a person with good commercial insurance historically could find themselves not covered for the exact same costs that normally would have been covered solely because they're getting some treatment that is part of a clinical trial. And that seems like a perverse incentive in the wrong direction for all of us across all of society, right? Melissa Dillmon: Exactly, especially at a time when it's challenging to get enough people on clinical trial, and we're trying to get more people on clinical trials. We're trying to remove those barriers. Clifford Hudis: Right, and I would go even a step further and say it's a little bit of a paradox because it doesn't actually cost the insurer any more money for a person to be on a clinical trial and be covered for routine care. It's not as if they're getting an increased charge back because the patient's on a clinical trial. The research study is typically covering the non-standard research components of care anyway, right? Melissa Dillmon: Correct. And then oftentimes, if there's an investigational drug, they're taking the cost of the drug out of the picture. So in some ways, you're actually saving the insurer that money. Clifford Hudis: So it's funny, as well, a little paradox that Medicaid is the only major payer not federally required to cover their costs. Yet at the state level, I think-- and I just heard about another one today, I'll tell you-- some states have taken half steps or full steps to require Medicaid to cover the costs of clinical trial participation for patients, right? Melissa Dillmon: That's correct. About a dozen states have taken action, through written statutes, or regulations, or policies, to require their Medicaid plan to cover these costs. But that's only a dozen states. That leaves about 42 million Medicaid patients who do not have guaranteed ability to participate in clinical trials. Clifford Hudis: You know, I think some listeners may be surprised that you get that big number-- 42 million. And of course, that raises some basic questions about the reach, and scale, and extent of Medicaid. I think we should talk about that for a moment. So who has Medicaid as their primary insurance? That is, who is covered by Medicaid-- what kinds of patient populations and so forth? Melissa Dillmon: So Medicaid covers about 20% of Americans. Patients on Medicaid are often lower income. It's usually children, older adults, patients with disabilities, and some patients in rural areas are more likely to have Medicaid. So depending on where those dozen states are that have those statutes, those may be states that don't have as large rural populations or lower income patients. So racial and ethnic minorities are also overrepresented in Medicaid. For example, African-Americans represent about 12% to 13% of Americans, but 21% of patients receiving Medicaid are African-American. Hispanics represent 18% of the American census population, but 25% of patients on Medicaid are Hispanic. Clifford Hudis: So this is the same old issue, where certain racial features, as it were, are surrogates for lower socioeconomic status, and that's what you're describing, unfortunately. Right? Melissa Dillmon: Correct. Clifford Hudis: OK. And so we take this group of patients that are, in general, a little bit disadvantaged-- lower socioeconomic status as an average, perhaps more rural, which itself represents a barrier to care-- and then you add on the limitation in terms of clinical trial participation coverage. So how does this translate into an increased burden for this special population, as opposed to everybody else? Melissa Dillmon: Well, we already know that cost is a major barrier to participation in clinical trials. Patients who have larger income are more likely to participate in clinical trials, or be offered a clinical trial, or live in an area where there is a clinical trial available for them. Patients who have a lower income-- less than $20,000 per year-- have a much lower participation rate in clinical trials, and we are therefore missing a lot of patients who could be benefiting from those clinical trials and who could be contributing to the science. And these patients don't have the financial resources to pay for their routine cost of care. They cannot afford to pay the E&M visit, or for a chest x-ray, or a CAT scan on their own. So that would pose a huge barrier for them to even consider participating in a clinical trial. And one of the things that frequently is stated is, of course, this means that if you can't participate in a clinical trial, that they might be missing out on life-extending or life-saving therapy. And we have to admit that that, of course, is uncommon, but not impossible. But there are also more subtle ways that clinical trial participation can benefit the individual. Clifford Hudis: They may enjoy a higher quality of life with some experimental therapies sometimes. And the other thing, of course, is that we all, as a society, benefit it clinical research studies are concluded more quickly. We get an answer faster and we can move on to the next big thing or build upon what we've learned. So it isn't as if the cost of this is limited solely to people with Medicaid. It's something, I guess, we all pay, right? Melissa Dillmon: As a society, I think we suffer when patients are not able to participate in these studies.

Subscribe through iTunes and Google Play. Dr. Joanna Yang and Dr. Robert Daly join ASCO CEO Dr. Clifford A. Hudis to discuss the Health Policy Leadership Development Program (HP-LDP). As former fellows, Drs. Yang and Daly provide insight as to how the program has made them better advocates for their patients. TRANSCRIPT Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series, where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis. And I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to be joined by not one, but two of ASCO's rising leaders, Dr. Robert Daly and Dr. Joanna Yang. Both Dr. Daly and Dr. Yang are recent participants in ASCO's Health Policy Leadership Development Program, formerly known as the Health Policy Fellowship Program. This is a professional development program designed to build health policy and advocacy leadership expertise among our members. It's a one-year program where fellows get practical experience working with our policy and advocacy staff and council to craft policy positions and statements, along with other educational sessions on communication, leadership, and advocacy. Starting this year, participants will be able to participate as well in ASCO's Leadership Development Program, which offers mid-career oncologists the opportunity to improve their leadership skills and gain valuable training to set them up to be future leaders in oncology. Dr. Daly and Dr. Yang, welcome, and thank you for joining me today. Joanna Yang: Thank you so much for the opportunity. Robert Daly: Yes, thank you so much for having us. CH: So Dr. Yang, I'm going to start with you. You were an ASCO Health Policy Fellow in 2017-2018. And I want to kick off our discussion by talking about what brought you to the program. Why were you interested in developing special expertise in policy work? JY: Sure. So I've always been interested in health policy. And I had the opportunity to study health policy and health economics during undergrad. But of course, studying health policy is very different than creating or influencing health policy. When I started residency, I saw many ways in which health policy on a national level or even state level affected the patients I was caring for. And I felt compelled to do more. But the issue is that there is never any clear way for me to get involved or even to learn how I could learn how to shape health policy. And that's why the ASCO program is so great. I feel like it came at exactly the right time. I was looking for a way to learn more to develop the skills I needed to influence health policy. And ASCO came out with this structured and immersive experience where I could take the things that I had studied in school, and also the things that I'd seen in practice, and use them to actually have an impact on the patients I take care of. CH: So Dr. Daly, you as well were one of our inaugural Fellows. What prompted your interest in applying for the program, especially given I think you were the first year? RD: Yes. CH: Right, so you took a leap off of the ledge there and said, I'll go first. RD: Yeah, I'm similar to Dr. Yang. I had a real interest in cancer care delivery research during my fellowship at the University of Chicago. And I was lucky enough to be mentored by Funmi Olopade and Dr. Blase Polite. And Dr. Polite was really fundamental and helped developing the ASCO Health Policy Fellowship. And so I really saw this as an opportunity to augment that training but really gain skills in leadership, advocacy, and health policy, areas that I hadn't had exposure to in the past. So this seemed like the perfect program for me at that point in my career. CH: I have to say parenthetically that I'm jealous of both of you, because while I was personally drawn, especially in later years in my career to the policy and advocacy aspects of work with ASCO-- and it truly is the reason that I moved from my traditional academic career to this role as CEO at ASCO-- I never, of course, had the opportunity to be trained and to learn how to do this professionally as you two have. So I am in awe of your accomplishments, as well as the opportunities that are going to continue to unfold in front of you because of this. So given that, and given that this is really the beginning, we hope, of a career with impact, we should talk a little bit about what you actually did. The program, as I mentioned earlier, lasts for a year. And during that time, Fellows worked very closely with our policy staff on a mentor project. So I'll start again with Dr. Yang. Can you talk about the project you worked, what it entailed, what you learned, and where this is going? JY: Sure. So I worked on a two-part project with Alex Chen, who was my co-fellow during the past year. And as you hinted at, the work is actually still ongoing. So the first part was we looked at whether a bundled payment model could work in oncology. And this really culminated in a white paper for us. But the second part of the project, which built on the first part, was really the most fascinating. In the second part, it was really asking, if not bundled payments, then what? And we actually built on some of the work that Dr. Daly did that he'll probably describe in a little bit. But we actually worked on designing a pathway-based alternative payment model. And of course, going into this, I had no experience designing alternative payment models at all. But the beauty of the program is that from the very beginning, Deb Kamin, said, we will not be having you do any work that is not necessary. So all the work that you do is important to ASCO, is important to our patients. And that was really true for our project. So we were able to work with the ASCO staff, and our mentors, Ray Page, and Linda Bosserman, and a whole team of experts to create an alternative payment model that we thought would allow oncologists to prescribe the right drug at the right time, without being penalized by the high drug costs. CH: So I guess, based on that, we really should have started with you, Dr. Daly. But your mentor project was centered around clinical pathways. And I understand that ends up being the foundation for the alternative payment model that Dr. Yang just described. So can you talk a little bit about that process, what you did as an inaugural fellow in this and what you learned as you went through the work? RD: Absolutely. So I was lucky enough to be able to serve on the ASCO Task Force on Pathways. So that was an incredible experience for me because I really got to interact with leaders on this issue, including Robin Zon and Ray Page, who are very active in cancer care policy, both at the state level in Indiana and Texas, but also on a national level. So to be able to gain their mentorship that early on in the fellowship was really a great asset for me. And we were looking at, how do we write the criteria for what constitutes a high-quality pathway? So I really got to see, from soup to nuts, how do you write a policy statement? How do you solicit input from those important stakeholders? So the stakeholders in this case were fundamentally the patients, but also providers, ASCO's Government Relations Committee and State Affiliate Counsel, ASCO's board, the vendors-- get all of their input together to create a policy statement that can really influence change. And then lastly, I played the part of representing ASCO and in discussions with the pathway vendors about these criteria for high-quality pathways. So I learned about the important role ASCO can have on influencing the development of products and services that impact patient care, but also the impact ASCO can have on legislation. So in California, Connecticut, and other states, they started to look at policy around pathways, policies around implementing the criteria that ASCO had developed, so that those pathways that were being used in their state were high quality. So it really showed me the reach of ASCO and the impact of ASCO on patients and providers. CH: That is amazing because it really is a reminder-- and I'm going to come back to this idea-- about how much impact one person and one project can ultimately have. And I think that in these sometimes cynical times, people forget that. I alluded to this before about my own engagement with ASCO was accelerated by my experience as an advocate on Capitol Hill-- again, an amateur to your professionalism. So I wonder if you would reflect on your experience during the fellowship program. I understand you were both frequently called on to join in advocacy meetings on Capitol Hill. And this is with federal agencies, as well as, I assume, with representatives, senators, and their staff. Did either of you have any experience doing this before ASCO took it to Capitol Hill? RD: I had never had any experience doing advocacy meetings. So it was really-- the fellowship really helped me learn how to do that and how to do that effectively. CH: What was the first meeting like? RD: My first meeting was here in Manhattan. It was at the office of Senator Gillibrand. And I was accompanied by Heather Hilton, who is an ASCO advocate and someone who's served on the Government Relations Committee. And I was really nervous. I didn't know what to expect. But we met with one of her health policy staffers and really had an engaging discussion about an ASCO advocacy issue where we really felt heard. We were able to share patients' stories and also deliver data that ASCO had collected to help support our view. So it was really an exciting experience for me. And then I got to replicate that experience on Capitol Hill, meeting with congressional representatives from New York in their offices, but then also, as you said, going to government agencies, which was a different experience as well. So I really got to see a broad perspective of how you can advocate for policy issues for ASCO. CH: Dr. Yang, how would you describe your initial advocacy meetings for someone who hasn't participated before? What does it feel like to walk into that first meeting and begin that first discussion? JY: Sure. I've done that for my friends before. I've described these meetings. And they always say, it's really not at all what they expected. And I think that Dr. Daly's description is exactly right. So you go with your group-- usually it's by state-- to the member's office. And then depending on how much room there is and how many meetings are being held that day, your meeting is either going to be in a conference room in the member's office or even, more frequently, in the hall or any room that's available. And the member is not always there, but one of their staffers is, or sometimes multiple staffers, who are always really young but super, super, super knowledgeable about the issue. Basically, you go around, and you introduce yourselves and then describe the issues that you're here to discuss. And it's interesting because ASCO always does a great job of making you exceedingly well-prepared with the facts. But the truth is that most members and most staffers are most interested in hearing the patients' stories, which is why it's so important that oncologists come to the Hill to have these meetings. I think that no matter how well you try to prepare, ultimately, it really just comes down to engaging with the staffer and finding some area of common ground. And cancer is so common that most of the time in these meetings, I find that staffers or members will say, I have a family member or friend or some other loved one who has cancer. And it's really great that you guys are here. CH: My own experience-- I mean, I'm here to talk to you. And the listeners want to hear from you. But I just can't help but share. When I got involved in this before you all were, the key issue that we were confronting was the decade-long flat-- in dollars-- flat funding of the NIH and the NCI. And my first trips to Capitol Hill consisted of virtually beating on doors and explaining why this was a mistake for the country and for our people, and getting what felt like the cold shoulder. Over and over again, the same arguments seemed to fall on deaf ears. But-- and this is an important "but"-- what I have learned is that repeatedly making rational, evidence-based, and appealing anecdotal arguments, just as you describe, can ultimately move the needle. And it does. And so my personal cynicism with regard to politics and making a difference has gone down, not up, with aging. And I think listeners should think about this. You will never go to a congressional office and change a mind in one quick phone call. But when dozens and hundreds of people do it repeatedly over months and years, we actually do have the chance to positively influence policy and legislative actions and regulations in the United States. And you should forgive me for waxing so poetic. You should be proud that you've committed to doing this early. And I hope you start to see the rewards. So I'm sorry to carry on about my own experience here. But it really is part of what has helped motivate all the staff to get behind this program and launch it and support it. Looking back, I'll turn back to you Dr. Daly. You're a couple of years removed now from the program. Can you identify one or several key learnings from your time as an ASCO Policy Fellow that have stuck with you, that you find yourself coming back to in your daily life? RD: Yeah, I mean, I think what you've just said, Dr. Hudis, about how you can really have an impact is something that I learned during this fellowship. It wasn't something that I had been aware of in the past, because I had never done advocacy work before in the past. So I think what this fellowship really trained me to do is to be an effective advocate. And that is something that I can use in a multitude of different areas as an oncologist. So combining the patient stories that we talked about that are so visceral and so needed when you're trying to get through to those legislators or policymakers that you're trying to reach-- but also backing that up with data, and I think ASCO really equipped us well as advocates to have the data, as well as the personal stories, to influence change. So using tools like CancerLinQ to be able to look at broader data sets and say, we know this is impacting our patients. We can see that. And now we need to think of a solution for change. And I think being involved in helping to create some of those solutions was also really valuable for me. So with the pathways, creating the policy paper, but also serving on committees during that fellowship year on MACRA and other issues, like opioid legislation, that were really affecting our patients, and seeing how ASCO is effecting change in those areas, was something that will stay with me throughout my career. CH: And how about you, Dr. Yang? Do you see any practical day-to-day impact, for example, in your work with patients from your time in the fellowship? JY: Yeah, absolutely. I think because I spent most of the past year thinking about high drug costs, both for chemotherapies, immunotherapies, and supportive drugs, I'm much more thoughtful about the costs that are passed on to our patients. And that can actually be really significant. And one of the things that I do much more often is I ask about cost to my patients when I prescribe medications. And that I really attribute directly to work that I was doing with ASCO. The other thing is that working with patients actually often gives me ideas. So I'll see patterns emerging. And I'll think, we really need to work on a policy that addresses this. And the great thing about the Health Policy Fellowship is that you remain involved with ASCO. So when I see these issues, I'm able to take them back to ASCO and to the committees. CH: Well, speaking of the committees, after you and all of our Fellows complete the one-year program, you were automatically added to one of ASCO's relevant committees. And I think you're both members of the Clinical Practice Committee. I'm curious-- I'll start with you, Dr. Daly-- has your time as a Health Policy Fellow helped you in your work on the CPC, and how? RD: I think, absolutely. It's made me more fluent in the issues that the CPC is confronting, the sort of things like the Oncology Care Model, rural cancer care. I now have a foundation where I'm able to contribute in a way on that committee that I never could have before or without the Health Policy Fellowship. CH: Yeah, I think it's often the case that sometimes-- or I shouldn't say often-- I think sometimes it's the case that people get onto committees and really do have a steep learning curve. It seems like maybe this could have accelerated your start on the committee. Is that your experience, Dr. Yang? JY: Yeah, I think so. I think that the Health Policy Fellowship, that first year is a really steep learning curve. But it does, as Dr. Daly said, provide a great foundation to just be aware of all of the issues that affect cancer doctors and cancer patients. CH: So I'm going to go to a little bit of a speed round, if you will, and ask you both to think about the other members of our community who have not had the opportunity to do this and might not ever have thought about it. Dr. Yang, finishing the program last summer of course-- so it's fresher, I think, for you-- why do you think it would be important for oncologists to be aware of and engaged in policy discussions, rather than nose to the grindstone, thinking about their clinical and research responsibilities on a daily basis? JY: Mainly, I really think that the reason for oncologists to be involved in this is that regardless if you are thinking about it or not, health policy affects you. And it affects oncologists. It affects how they practice. It affects how they are able to care for their patients and the type of care that they're able to provide. And if oncologists aren't involved, their voice is going to be lost. And oftentimes, they're the most important voice for their patients. CH: And Bobby, what would you say to the old version of me, the cynic, who says, this is a waste of time-- I'm not getting involved? RD: Well, I do think it really makes your career more exciting to be involved in health policy issues. It really broadens your view of how you think about patients and how you think about cancer care, and makes coming to work every day, I think, more exciting because you have this other lens that you're looking at issues with. CH: And looking back more specifically, and not intending to turn this into a sales job for the Policy Fellowship-- we only have two slots a year-- but I wonder what each of you would say to young colleagues thinking about this. What's the best reason to get involved in the Health Policy Fellowship at ASCO? I'll start with you, Dr. Yang. JY: I think that if you're interested in quality of care, the costs of care, access to care, then this fellowship is the right fellowship for you. And I think that being interested in those things doesn't necessarily provide you with the skill set you need to actually do meaningful work in that realm. And I think that the fellowship program really does provide you with tangible skills that you can then use to write policy briefs, to hold meetings, to be an advocate, all of which are really, really, really important. CH: Dr. Daly, is there anything you can add to that? Or does that pretty much sum it up? RD: I think that's absolutely right. I would just add the mentorship of the fellowship is really incredible, so getting to interact with the ASCO leaders, like Robin Zon, or Ray Page, or Blase Polite, but also the ASCO staff as well, who are incredible in the policy area, like Deb Kamin. I think I learned so much from being in their presence for a year and just absorbing all of their knowledge that they had, an experience they had. And when I was at the annual meeting just a couple of weeks ago, it was just such a fun pleasure to be there and see all of them and know that those relationships are something that will be with me throughout my career. And they really influenced me. CH: Wow. I think that's great. And I am so proud of both of you and all the participants in these and the other development programs that we offer. I will share with you that from the perspective of the board of directors, these programs really represent the crown jewel, something that the board members take the light in. And you should be proud to have contributed the way you have. So Dr. Daly, Dr. Yang, I want to thank you again for joining me today for this ASCO in Action podcast. RD: Thank you so much for having us. JY: Thank you. And for all of our listeners, if you want to learn more about ASCO's Health Policy Leadership Development Program, please visit us at asco.org and search for "policy leadership." The application period for the 2020-2021 year is now open, and it will be open through the end of September. So there is time to get those applications in. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast.  

Subscribe to the podcast through iTunes and Google Play. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence. The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today. Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis. CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient? RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product. The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests. FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome. CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications? RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient. This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA. CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients? RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website. We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now includes the expanded access programs listed in ClinicalTrials.gov. Patients and physicians can look for treatment options. They could discuss clinical trials, and company information could be provided at the navigator at Navigator.Reagan-Udall.org. So this is really to give patients and their physicians information about what is out there. Once the patient obviously has this information and their doctor, then the doctor can utilize the Project Facilitate, which allows easier access to actually submitting these forms and going through the actual process. I'd like to emphasize that companies are now required by the 21st Century Cures Act to publicly list their expanded access policy. And the Reagan-Udall Navigator website helps them comply with that requirement. Again, so once the physician and the patient have identified the investigational therapy they want to try, the physician or other members of the health care team then can contact Project Facillitate for assistance in locating IRB resources and help with the FDA form 3926. CH: So I think you mentioned this when you launched this or announced it at the annual meeting just now, that physicians do already-- or at least before project facilitate often would successfully go straight to pharmaceutical companies and ask for treatments. And I guess in some cases they'd be denied, and in some cases they would be approved. And that would be through the company's expanded access programs. Obviously, that means that regulators wouldn't necessarily know the full extent of expanded access use. So assuming that Project Facilitate will allow the FDA to collect much more data on expanded use, how will the data be useful? And obviously, I'm hinting at the fact that some fear that it will be actually a negative. RP: Well, prior to launching Project Facilitate, the expanded access requests for cancer patients arrived at multiple places within the FDA and were forwarded separately to FDA oncology or hematology   divisions. Sometimes these requests could be delayed, being sent from one place to another in the agency. So this gives a focus point for physicians to contact. In addition, we're seeing that most of the expanded access requests were coming from patients and physicians at larger academic centers. The patients who don't live near these cancer centers and may not be able to get on clinical trials can also hopefully have access to investigational agents by having a more facile and easier process to use here. We're also seeing that many companies have turned down requests from patients, and we have no idea what really the number of requests a company may get if they're turning down these requests. Because generally, they don't come to the FDA. So really, by having the initial contact at the FDA we'll be able to determine number one, the number of patients that are requesting a single patient access. We'll also be able to determine and discuss with the companies their reasons for denying these requests. And there could be multiple reasons. And we also have a process in place that can follow up with what are the benefits that an individual patient may have from this therapy or, as I stated before, were there any adverse events. We have also heard this kind of urban myth-- and I label that in quotations, "urban myth," that companies fear that perhaps adverse events may be held against them when their drug is coming for drug approval. We have not done that. We take into context where the adverse event reporting is coming from. And there really are no instances that I am aware of in oncology where a report of an adverse event has delayed or curtailed an approval of a drug. CH: So really, this is a bright ray of sunshine on a dark corner of drug access. And if it works right, you'll just have much more understanding of the overall use of expanded access. Right? RP: Yeah. I think that gives some clarity to the process here. Here again, we don't know the numbers at this time of actually the number of patients. We only know the numbers of patients that receive a affirmative position from the drug company regarding that the process can continue. But we don't know the numbers of patients that may be requesting single patient access and are denied by an individual drug company. And also, the reasons. And, as I stated before, there can be very legitimate reasons, including inadequate supply of the drug, lack of support staff to follow up on these drug requests, potential interference with clinical trials that the patient may be eligible for. CH: You just used a phrase about patients requesting. And I thought as you described this process you were referring to physicians requesting on behalf of patients. And so I do want to ask, are there resources that are aimed directly at patients or is it really solely aimed at the oncologists in this case? RP: Well, here again, this is a two-prong process. Project Facilitate, the FDA portion of this, is for physicians to call up for assistance in filling out the form and also navigating the process once the decision is made. The other prong of this is, as I stated before, by Reagan-Udall foundation, which patients can call to look at what our options available to them that are potentially listed on ClinicalTrials.gov. And that is also for patients and physicians. However, the portion of the program that is Project Facilitate is for the requesting physician. CH: All right. Well, that's clear. So once we talk about patient's involvement, and even many physicians I think for that matter, we quickly can drift towards the very heated discussion that took place in public over the last year in the area or that we call Right to Try. And I wonder if you could talk for a minute and help us, for the listeners, make this distinction between expanded access and Right to Try. RP: Of course. These programs, Right to Try and single patient INDs are really mutually exclusive programs. The main difference between these programs are first, that under Right to Try the drugs have to complete a Phase I trial. For single patient INDs, it could be done anywhere, even within the context that the drug is being conducted in a Phase I trial. However, the major difference is that the FDA and the IRB does not review Right to Try applications, whereas under a single patient IND, the FDA obviously has to give permission for the patient to proceed as well as an IRB has to review these requests. CH: So to be very clear, Project Facilitate is supporting the single patient INDs, and Right to Try is a separate matter entirely. They are distinctly different programs. Project Facilitate does not apply to Right to Try. That is an independent, separate program. CH: Great. So, you know, one of the problems for a busy clinician is figuring out how to do all this under pressure with a sick patient, and the other pressures of clinic and administration and research. If our listeners want to learn about this more casually, where can they go not under duress, just to start reading up and learning about how to access the program? RP: They could go-- physicians can go and learn more about the program at our website, www.FDA.gov/oce. The Project Facilitate phone number is 240-402-0004. That's 240-402-0004. And the email address is ONCProjectFacilitate@FDA.HHS.gov. CH: That's great. So hopefully, some of our listeners will take advantage of that and learn about this when they're not under pressure so that they're familiar with it if they have to turn to it some months later. Now you mentioned that the host is the Oncology Center of Excellence. And I mentioned in my introduction that we would want to talk a little bit about that. CH: You've been at the helm of the OCE since it was established a little over two years ago, I think. Now that you've been in the role a while, I wonder if you could talk a little bit about your view of what the OCE should be accomplishing, and maybe how that aim has evolved over these two years. RP: Yes. The OCE basically was an offshoot of the Moonshot Program several years ago, and was aimed to be the first center that coordinates activity among the therapeutic center. Obviously, at the FDA there is a center for drugs, a center for biologics, and a center for radiologic health and devices. And they all can review oncology products. The OCE has a designation to really coordinate the activities, particularly in the clinical review of the products that involve the treatment of cancer. So, this is a unique center within the FDA, and is somewhat of an experiment at the FDA to see how we can really coordinate the activities of drugs that affect cancer patients. And here again, the oncology center is primarily designated for the clinical review. And we don't really get into the manufacturing of drugs. That's handled in the individual centers, whether it be a biologic and CBER, the Center for Biological Evaluation and Research or CDER, the Center for Drug Evaluation and Research. With that given said, in addition to the actual bread and butter of reviewing applications, we have many research projects that we're doing. We have a big project looking at real world data. We have a project looking at updating labels called Project Renewal. We have, as I stated before, this project that we launched at this year's ASCO, Project Facilitate. We also have a project aimed at really improving our relationships with international drug regulators. We have monthly meetings, teleconferences with five different regulatory agencies throughout the world to go over applications and discuss different regulatory policies. We have a host of a symposium that we conduct both here at the FDA, inviting external stakeholders including physicians, leading academics, patients to come to the FDA really to discuss important topics to our drug reviewers and the entire discipline of regulatory and oncology, so to speak, how we make decisions in medicine. We have a whole, also, program that we're developing aimed at educating physicians and other health care professionals for educating other health care professionals on how we evaluate drugs, what our thought processes are here at the FDA. So, in addition to the regulatory work, there is a whole body of scientific work that we're also doing, including independent research on different databases, looking at patient populations more likely to respond to different drugs, ways of evaluating and describing toxicities, ways of really looking at patient experiences while they're getting drugs, and different ways of reporting patient reported outcomes. We'd like to thank ASCO, obviously, for their assistance during and helping us with many of these projects throughout the year, especially the educational projects involving fellows, involving different topics that we've found of interest that needed to really have a public disclosure in the community, really, to get input from leading academics, as well as treating physicians. CH: Wow. You are busy. And there's a lot we could unpack there. But I do want to pick up on a couple of things. First of all, you described this as an experiment, so I'm curious. And not to put you on the spot, but if you have an experiment, I presume that just some metric that you would use to call it a success or failure. And I wonder where you think you are right now in that regard. It sounds like you've gotten a tremendous amount done. But are you satisfied, for example? Have you covered the ground you wanted to or do you think that you could be doing more? RP: Well, people who know me realize that I'm never satisfied. So, I think we're in the middle of this experiment. I think it's going quite well. And I think that this is really going to be aimed at-- and the evaluation of the success or failure of this is going to be really how the individuals that work here at the FDA really evaluate drugs and how we facilitate the evaluation of drugs. And also the really important of retention of staff here at the FDA is a major issue, also. And I think many of the projects that we have ongoing really develop our reviewers in really having a real world approach to how oncology drugs are used. So it's very difficult to say what success and failure will ultimately be. But I think we're on, really, the correct path, and pretty much a straight path of looking at a successful venture here. CH: You know, one of the things you said reminded me of another urban myth. And I don't know if you realize this. But when you describe the careful coordination with, I think you said five regulatory agencies around the world, it raises the myth, I believe, but you can address this with some facts, that many people in the United States believe that others around the world have faster access to a broader range of effective therapies. I wonder if you want to expand on that or comment on that at all before we move on. RP: Well, that is an urban myth, and probably was generated 20, 30, 40 years ago when that may have been the fact. Obviously, that antedated my coming to the FDA. But I can say the vast majority of drugs are approved first in the United States. And those include very important drugs such as the PD1 drugs, the targeted drugs, et cetera. They are approved first in the United States. We have taken a very active approach to really rapid approvals of our drugs without sacrificing quality, by having a smarter approach to how we review these drugs, with putting multiple reviewers on particular applications, by cutting down on unnecessary paperwork that many of our reviewers had to do, and really focusing on really the core material that we have at hand, and really emphasizing does this drug really demonstrate safety and efficacy. At the end of the day, I charge all of our reviewers with the following statement. Would the American public be better with this drug than without it? And that's the ultimate decision that we have to make at the time of approval. CH: Well, that's another perfect segue to a hot topic, which you and I have discussed actually offline before this. But I'm going to come back to it. The expedited approval of anticancer therapies was recently the subject of a paper in The Journal of the American Medical Association. And if I remember correctly, they looked at 93 cancer drugs that had been approved through accelerated approval process. But what they claimed is that only 19 of the 93 clearly extended the lives of the patients taking them. That's a value judgment, obviously, about why drugs are approved and introduced to the market. But I wonder if you would want to talk a little bit about your view of some of the complexities and challenges that are inherent in accelerated drug approval, and what your view is of this particular study of the approval outcomes. RP: I think many times people don't understand that it isn't just about overall survival. Obviously, that's the gold standard. But we've had very careful discussions throughout the years that there are many ways to evaluate benefit to the patient. And that includes reduction of the size of the tumor, delay in the progression of the disease, the establishment of complete response rates in hematological diseases. So we have to have some flexibility, both in terms of how we approve drugs and what clinical trials we're going to ask for after drugs have been approved on the accelerated approval pathway. Although overall survival is a very important end point, it's an important efficacy endpoint as well as a safety endpoint, it does have limitations. As we move more toward a targeted therapy and subsegment common diseases into molecular subtypes, many times we find that we have very limited populations. And simply, we don't have the size of a population that we approve the drug on to really do a large, randomized trial. So we have to weigh that issue with what type of trial we're going to ask for, both with the initial approval of the drug as well as with, perhaps, the subsequent studies that we ask for after an accelerated approval. In addition to that, many times we find that we have situations where the disease itself may have a very long natural history, such as CLL or other diseases that may have very long natural histories, where one cannot really do a long-term survival study because it would extend many, many, many years. And many times-- and I think we have to be realistic about this, that there may not be equipoise here to allow a randomized trial to be done looking at overall survival as a primary end point. For example, if we already have information that a drug may have a response rate of 50% or 60% and the comparator drug may have a response rate of 10%, patients will not want to go on a study that looks at overall survival as the primary end point. And many times, we have to take a look at time to progression or progression free survival and those end points, and actually allow for a switch in therapies or crossover at the time of disease progression, which renders the evaluation of overall survival somewhat difficult, and may confound that evaluation. So, there are many reasons why overall survival, although a gold standard, may not be applicable to all situations. And I think that's going to be increasingly so as we get into a more targeted therapy approach and have better definitions of who is going to respond. So here again, it's long natural history of diseases either by its natural history or by the therapies that have been approved that prolong disease. It could be due to the limited populations, which preclude a randomized trial. And it could be due to the lack of equipoise, which really bands that patients have access during the course of disease. I think a much more important question, and one that we are constantly looking at, is not so much what does an individual drug do to the natural history of the disease and prolonging survival in patients that have metastatic disease, but what is the impact over the years of multiple drugs being approved on the basis of progression-free survival or response rates when they are used either in combination or sequentially. And we could see that, for example, in multiple myeloma, where the course of that disease has been significantly changed, and patients' lives have been prolonged. And the vast majority of the drugs that have been approved have been on non-survival endpoints. And this is true not only for multiple myeloma, but also probably for renal cell cancer. CH: Yeah. That's interesting. It's a challenging analysis, of course. But that would be a very interesting, essentially public health roll up of all of these incremental decisions. Right? RP: Correct. CH: Yeah. So, as I said before, the OCE has been in operation just over two years. During that time, more than 80 therapies and products have been approved, I think. Right? And there've been more than a dozen guidance documents approved, 60 workshops and symposia for oncologists and for patients. And there were several of those workshops that we at ASCO were privileged to co-sponsor along with you. This is the favorite child question. But what's your proudest achievement so far? RP: A difficult question, but an easy question, too. It's about the people that work here and the patients that we serve. And I think my brightest moments are when we see the development of our people coming in and taking leadership positions both within the agency in a regulatory context of their job, but also in the academic fields and participating in conferences, publishing papers, and really finding enjoyment in the job that they have outside of the day-to-day regulatory activity. One of the things that I have always emphasized since I came here 20 years ago from an academic medicine position at M.D. Anderson is really to give the agency a much more academic perspective. And I've always stated that I think we do much more academic work here at the FDA than many academic centers. And I'm not talking about the generation simply of papers or research grants. I'm talking about actually critical thinking of what goes on at an application, since we have a multi-disciplinary team of statisticians, clinicians, clinical pharmacologists, toxicologists, manufacturing people that all work together. So it's really about-- my greatest accomplishment is really about the young people that have come in that I've mentored, and really have assumed roles, and really will be my lasting legacy here. But I also want to emphasize that one of the things that I have repeatedly highlighted to this staff is really to consider the patient in really any regulatory decision. Here again, it's not about a P value. It's not about a primary end point. Granted, those things are important, but we really have to bring together the whole body of information about a drug in making a regulatory decision and making that a patient-focused thing. And as I stated before, at the end of the day will the American patient-- will the American public be better off with this drug than without it? CH: Well, Rick, I got to say that's an inspiring description. It makes me wish I were younger, and maybe I could come and be mentored. But alas, it may be too late for me. But we really are proud to work with you, and to work with so many of your staff in many productive collaborations. I want to thank you again for joining me today for this ASCO in Action podcast. We always appreciate your expertise and your perspectives. And we look forward to continuing to work with you to ensure that patients with cancer have access to safe and effective treatments. RP: And thank you, Cliff. It's been a pleasure. And here again, I really think ASCO for providing a lot of resources to us in conducting symposium, and really in fostering better cancer care for patients. I think that's the ultimate goal of both organizations. CH: It sure is. And I want to remind our listeners that you can follow the FDA Oncology Center of Excellence on Twitter. Their handle is @FDAOncology. That's one word. You can follow me @CliffordHudis, and you can follow ASCO @ASCO. For more information on the latest cancer policy news and updates, visit ASCOAction.ASCO.org. And Rick, I'm going to ask you once more to remind the listeners of the way they can access Project Facilitate. RP: They can learn about Project Facilitate from our website at www.FDA.gov/OCE. And our project facilitate phone number is 240-402-0004. And the email address is ONCProjectFacili tate@FDA.HHS.gov. ONCProjectFacilitate is spelled O N C P R O J E C T F A C I L I T A T E @FDA.HHS.gov. CH: That's great. So until next time, I want to thank everyone for listening to this ASCO in Action podcast.  

Subscribe through iTunes and Google Play.   In the latest ASCO in Action Podcast, ASCO’s President, Dr. Monica Bertagnolli, FACS, FASCO sat down with ASCO CEO Dr. Clifford A. Hudis to discuss cancer care in rural America. Improving cancer care access in rural America has been a signature issue in Dr. Bertagnolli’s presidential year, during which she has held town halls in communities across the country to discuss the real-world challenges facing patients in rural America and their cancer care teams. The podcast reveals some of Dr. Bertagnolli’s learnings from her town halls, and she explains what rural cancer care in America looks like today and offers steps to improve rural cancer outcomes in the future. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series.   For today's podcast, I am delighted to have with me today ASCO's current president, Dr. Monica Bertagnolli. And we're going to be talking about cancer care in rural America. Dr. Bertagnolli has long been a champion for improving access to cancer care in rural America, and it has been a signature issue for her throughout her presidency at ASCO. Indeed, she has held town halls in communities across the US to discuss the real-world challenges that face patients and the entire care team in these locations.  She shared some of those learnings recently at ASCO's State of Cancer Care in America event, which we entitled Closing the Rural Cancer Care Gap. Today, we're going to talk about what rural cancer care looks like in America and how we can take steps to improve outcomes in these many communities. Dr. Bertagnolli, welcome and thank you for joining me today to discuss this important topic.  It's great to be here, Cliff.  So, to kick off our discussion, I'm going to ask you to describe briefly some of the disparities that currently exist between patients with cancer in rural areas compared to those who live in urban or suburban areas.  Well, just imagine that you live in a town where most things are certainly like they are anywhere else, except the hospital is a very small one. The medical care is a primary care physician and maybe a general surgeon. They can do X-rays. They can diagnose most things. But if you have a need for anything beyond the basics of care, you have to drive three, four, six hours in order to reach it.  I think, throughout our country, we really do have a health care system that gets to most people. But particularly when it's an issue of specialty care, such as a cancer diagnosis, that's not always available.  Finally, there's a lot of our country that fits in this category. By the one government agency that looks at these things, the Federal Office for Rural Health Policy, 84% of the country, of the geographic area of the United States, is a rural location. And in that 84%, 18% of the population lives. So, we think, in oncology, it's very important that we understand more about the people who live in these locations so that we can figure out how to get them what they need.  So, starting in a quantitative way is an interesting mathematical representation, that about a fifth of the country in population is distributed over more than 4/5 of the landmass. And I think that's a way of visualizing the lack of density. But there are common challenges that patients in rural areas face that go beyond just distance and geography. What are some of those that you have uncovered and thought about this year?  You know, it's important not to overgeneralize, because certainly, there are people from every single socioeconomic status and walk of life that live in rural locations, no question. But when you go into big generalities, people who live in rural locations tend to have less education level. They tend to be less affluent. They tend to have more risky behaviors, more smoking and alcohol use. And some of the things that we know are associated with cancer development in general seem to be more predominant in rural locations. And finally, citizens who live in rural locations are, again, generally less likely than those who live in urban locations to have health insurance.  Yeah, so that's a long list of challenges that are only compounded by the geographic challenges that we spoke about before. We go and look at the most recent data that I think you shared at ASCO's State of Cancer Care in America. As we noted a moment ago, just under a fifth of the US population lives in these rural areas. But going one step further, not focusing on landmass but now focusing on the oncology workforce, fewer than 10%-- in fact, we think it's about 7%-- of oncologists practice in those areas. So, on the one hand, there's a lower distribution of American citizens into that space, but there's even proportionately a lower distribution of oncologists. How does this impact patients with cancer?  Well, it's a little bit of what I was referring to before. Going to see a specialist when you've got a disease such as cancer, where knowledge outside of the usual primary care physician's scope is really important, and by the fact that such a small percentage of oncologists live in rural areas and the fact that, in rural areas, distance is so great between various locations means that patients who have cancer just don't have access to the experts that they need.  To get that access, they have to travel. And there's not really public transportation that works between cities that might be 100 miles apart in some rural locations. So, the single greatest issue I hear from many patients in rural locations is the challenge of distance.  Yeah, it's really amazing. So of course, as I'm sure we're going to talk about, at ASCO, we don't enumerate these problems just to make a list. We do this to try to take action, to do something about it. And I guess the first question, and I know one that you've started to think about with ASCO volunteers and staff, is the fundamental one. How can we support the existing infrastructure, the existing oncology workforce in those areas? And taking it a step further, what can we do to possibly expand this workforce, at least bring it to parity with the population distribution?  We were really fortunate to have a very talented team of physicians within ASCO take this task to heart over the last year. And they formed a task force to look at issues of rural access to cancer care. It was led by Dr. Bhatia, who's from the University of Alabama-- Birmingham. And they produced a really great roadmap for us. The one area you're alluding to now is workforce. How do we get care providers? Or how do we get our patients in rural locations access to the care providers that they need?  There's a couple of different approaches the task force identified. The first is to think about education opportunities for rural health care providers. For example, one of the gaps that the task force identified is people with knowledge for the particular needs of cancer patients who live in rural locations.  Well, knowledge is something that ASCO is-- that's our core mission to provide. And so, the task force brought together a whole list of things like expanding ASCO meetings to locations throughout the United States, making it easier for rural care providers to attend, designing and implementing virtual tumor boards. Telephones are everywhere, either web-based or telephone-based communication networks that will allow those taking care of patients in rural locations to get information that they need specifically and support them there.  And then finally, every community is different. Every rural location is different. And one of the things we realized we needed to do as an organization is reach out more to everyone and just find out, what are the individual needs of our care providers?  So, in a way, you're raising the issue of complexity in terms of the built and available infrastructure. But that's paralleled, as was pointed out in the State of Cancer Care in America event, by complexity in terms of our understanding of cancer and how we treat it. So, what challenges does this increased complexity bring to those oncologists and other clinicians who care for patients in rural areas. That is, is it different for them or just more of the same?  So, I can give you some snapshots, because I visited seven different rural communities during my year as ASCO president. And some of the common things all have to do with distance and have to do with access to specialists. But there are other specific issues to each location. Let me just give you some quick examples.  In South Dakota, near the Pine Ridge Indian Reservation, there was a great need for programs that could help address cancer control, screening for cancer, smoking cessation, education for diet and overall wellness, and providers who could engage with the Native American population in order to educate the population and provide those services.  At the complete other end of the spectrum for that community, there was no access whatsoever to palliative care services. So the oncologists, who were about 100 miles away in Rapid City, were struggling with, what do we do when we have an elderly resident of Pine Ridge who has a terminal illness, and we don't have the ability to support them to get palliative care?  And what the community is doing is partnering with health providers that work through the tribal council to provide these services. But when someone needs advice, needs a consult, they have to have someone to reach out to. And that is networking through the teams in Rapid City. That's the way they're beginning to solve those problems, kind of a regional network of support and help.  Another quick example I can give you is in Appalachia. There is a rural community I visited with Electra Paskett in the Appalachian counties of Ohio, where, again, it's about a two-hour drive to the nearest large cancer center. There, it's a combination of regional hospitals who provide services to cancer patients and the Ohio State University, where the most acute patients with very high-level specialty needs can go for consultation.  A patient, let's say, with acute leukemia who's from rural Appalachia and needs to be treated would be transported to Ohio State. Others with more routine care are cared for by providers who are oncologists locally.  So, it's different in every location. I think the underlying theme is collaboration with whatever resources are closest, and finally, the ability to have people who really go deep into the community and problem solve. They all kind of have the whatever-it-takes attitude and come up with very creative solutions particular to the patients that they're serving.  It sounds like, as you described all that, that it's awareness, knowing your limits, and then it's networks and connections that really are the pieces of the solution. Does that make sense to you?  Yeah, that's very well said. And one size absolutely does not fit all. The other thing that you notice is, it's about the whole community, not just the individual patients and their doctor. I heard so many stories of neighbors helping out, somebody arranging to drive someone who was ill to a doctor's visit hours away, neighbors being willing to take care of-- one situation was where the neighbors chipped in to take care of an entire family while the mother was away having radiation therapy for her cancer at a city two hours away. These are the kinds of special challenges that you see in rural locations.  Yeah, I mean, you're really just drifting back and forth in and out of conventional, mainstream medical system infrastructure into the broader community. As I think about that, everybody who's listening to this, of course, knows you because of your years of leadership in the realm of clinical research, which is another component of all this we haven't yet touched on. But often, access to clinical research is a surrogate marker for access to high-quality care-- not always, but often-- and it's certainly an indicator of access to cutting-edge care. So I wonder if you want to talk a little bit about access to clinical research in these disadvantaged rural communities?  I'm so glad you brought that up, Cliff, because we're completely in the dark without research. Like I said, I've gone around and visited these various locations and realized that even though I grew up in a rural area, very rural area of Wyoming, when I visited rural Appalachia and rural Texas and rural even North Dakota, which is very similar to Wyoming, I realized that I really couldn't fully understand the challenges in those different locations. And the only way to understand what patients really need, what they're facing, and how to best help is by research.  It's a way-- in this, I'm saying that one of the most important things we can offer our cancer patients everywhere is the ability to have their challenges addressed by research so that we truly understand them. That's the only way we're ever going to make progress.  So, one of the things that the US government, I think, has done well is the National Cancer Institute has a network of research groups under the National Clinical Trials Network that are centered within community practices and community locations. It's the National Clinical Oncology Research Program, or the NCORP. And almost all of the NCORP sites spread throughout the United States have at least significant outreach components into rural communities for cancer research.  Finally, the US Comprehensive Cancer Centers also have a really important mandate to serve their community, and their community for most of the Comprehensive Cancer Centers includes rural locations. So, it's a hub-and-spoke model that's been developed for research. I won't say that it's perfect, because it certainly could be broader and more comprehensive. But it's a very, very good start, and right now, it definitely covers a large portion of rural America.  And I'm just curious. Is it too soon, or do we yet have data that shows that there's been an uptick or a change in registration out of those rural communities to clinical research trials?  We do know that we have more-- that when you look at the National Clinical Trials Network participants, the patients who enroll on those studies, that the proportion from rural locations is higher than it is in most clinical trials that are done by, say, the industry. So we do definitely know that it's been helpful.  We still don't have the numbers of rural residents in clinical research that meet their population needs. I mean, the patients who live in rural locations are still vastly underrepresented in clinical research. But this goes along with the multifactorial issues of being in a rural location. We know that it's harder for uninsured patients to be in clinical trials. It's harder for anyone who has to travel to participate in clinical trials. And it's certainly harder for individuals of lower socioeconomic status to be in trials. So we've still got a long way to go.  Well, you raised the one that's always in these discussions, the 800-pound gorilla, and that's insurance. Residents in rural areas are less likely to have employer-sponsored health insurance. They're more likely to live in states that have not chosen to expand Medicaid. And the issue, of course, is that when we don't have adequate insurance, that puts a strain on the system in terms of access to care and reimbursement to those who are in the area trying to care for them. So how does that reality affect patients? Is that just another layer on top of everything we've said? Or are there specific places where you see that impact?  Oh, it's another part of this very multifactorial problem of citizens living in rural locations. And it translates into something very, very real. So one of the best data that I've seen recently is that from 2011 to 2015-- I believe this is the last time it was looked at comprehensively-- the CDC looked at death rates from cancer and compared death rates in cancer between urban and rural areas. And the death rates in rural areas were 180 deaths per 100,000 patients, persons, people-- sorry-- to cancer compared to urban areas where it was 158.  So there's a significantly higher death rate from cancer for citizens who live in rural areas. So it's not just access to research. It's not just the availability of specialists. It truly is access to care in a way that translates into survival.  Well, as I mentioned earlier, enumerating all of these challenges is just a first step. And I want to talk a little bit about what we can do to start to address them. Before I make that pivot with you, I just want to make sure that we don't leave anything important behind.  You've been in communities all around the country. You've interacted with patients, other caregivers, oncologists about the challenges of delivering care in rural communities, and you've already detailed a lot of this. Is there anything that we haven't touched on that you want to essentially put on the board before we pivot to solutions?  Only that the overwhelmingly positive thing I found in all of my travels is that the communities-- the rural communities-- truly value the interaction with their care providers. And it is very moving to see how medical care providers in a rural setting are absolutely essential components of the community.  We take it for granted when you live in an urban location that if you have appendicitis or you have a cancer diagnosis, somebody's going to be there to take care of you. That is never taken for granted in these rural locations. And it's very moving and very special as a physician to be able to witness that.  Well, so we'd like to have more of those places, in a sense, where they're lucky enough to take care for granted. And to that end, last fall, ASCO convened a group of our volunteers and board members-- you alluded to this already-- to take a closer look at the issue of rural cancer care. The group identified four primary areas where ASCO could better support rural oncology providers and their patients. And these included-- you touched on this already-- provider education and training, but also workforce development, a tighter embrace, if you will, of tele-oncology, and a focus on rural cancer research.  Further, as you know, during the recent State of Cancer Care in America event, we kicked it off with an announcement that ASCO was convening a Rural Cancer Care Task Force. This is different from the board task force earlier in the year. This one is going to focus on building on that work and making recommendations for specific tools and projects that we can launch.  So knowing what a priority this has been for you throughout your presidential year, I have a question for you, which is, where do you think ASCO can best serve patients in rural areas? That is, what resources would be most useful to our members, the providers who are serving those populations?  So I think ASCO is in a wonderful position to be in a forum, to listen to and enlist the help of those providers who really work with patients from rural locations, and to be able to hear from them directly what they need to better support their patients.  In South Dakota, I heard it was better support for palliative care and better support for access to preventive cancer prevention and cancer control programs. In Laredo, Texas, it was about figuring out how to get people health insurance coverage for the very expensive medications that were involved in cancer care. In other places, it was about being able to have someone available for consultation when they needed it, either by a telemedicine approach or by something as simple as being able to know exactly who to pick up the phone and contact when someone on the front lines had a specific patient need.  Finally, there are a lot of problem-solving strategies that certain providers and provider groups are implementing that are working well for them, but they seem to be still in a bit of a vacuum. Getting providers from across the United States to be able to come together and talk about these issues and share what's working for them, I think, will be very powerful for everyone else in this field.  It sounds like at least part of this is something I've taken to calling ORFA, which is organized resources for access. That is fundamentally what I think we find is a repetitive, recurrent need across all communities, but maybe even more pointed in rural communities in America. Is that fair?  I think that's very fair. And I think there are going to be some things that are truly unique to the rural locations, that are decisions that are going to be made that will be different than medicine practiced in more urban locations. For example, there are different ways to deliver radiation therapy. That may be a trade-off that someone who lives in a very rural location will pick rather than someone who lives in an urban area, where they have the ability to have five weeks of radiation therapy.  Some of the brachytherapy approaches, for instance, to breast cancer or to prostate cancer would be more-- might be chosen by patients who live in rural locations more than they would someone who lives in an urban area. I mean, there are even very specific modalities such as this that we may end up seeing practiced differently in a rural versus an urban setting.  Well, I can't thank you enough for taking the time to talk to me and enlighten our listeners on the topic of cancer care in rural America. As I've remarked throughout the year, your presidential year has been both consequential and engaging. And you manage to not only focus on, I think, critical problems, but also on plausible solutions. And I think that's the mark of a real leader, and we're very grateful to you for that.  Cliff, thank you so much. It's been a great honor, and I really enjoyed talking to you today.  I want to encourage our listeners to go and watch a recording of the State of Cancer Care in America event Closing the Rural Cancer Gap. The full-length recording is available on our Facebook page, or you can find it directly at ASCO.org/stateofcancercare. Until next time, thank you for listening to this ASCO in Action podcast. 

Subscribe to the podcast through iTunes and Google Play. Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action Podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Cliff Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am really delighted to have Dr. Lowell Schnipper, chair of ASCO's Value of Cancer Care Task Force as my guest today. In addition to his extensive service to ASCO, Dr. Schnipper is the Theodore W. And Evelyn G. Berenson Professor of Medicine at Harvard Medical School, Chief of the Division of Hematology/Oncology at the Beth Israel Deaconess Medical Center, and Clinical Director of the Beth Israel Deaconess Cancer Center. He is also an Associate Director of the Dana-Farber Harvard Cancer Center and a member of the Cancer Center's Executive Committee. Now, to provide some background for our listeners, I do want to highlight a couple of related points. First, as early as 2007, ASCO, led by Dr. Schnipper, was already focusing on rising drug and health care costs. And two, as detailed in our five-year strategic plan, almost everything we do at ASCO is aimed at helping our members and all of society achieve high-quality, high-value care for all people with cancer. Examples of the latter include our Patient-Centered Oncology Payment model, our participation in the Choosing Wisely campaign, our entire CancerLinQ project, and ASCO's Quality Oncology Practice Initiative, or QOPI, which is now available internationally. So our conversation today will focus on one longstanding project that's part of all of this effort. And this is one that's been a critical component of our efforts going back really, starting in 2007, ASCO's Value Framework. Here, I want to note that both ASCO and ESMO have developed algorithmic scales that are designed to evaluate the benefit of new cancer therapies. Again, ASCO's is called the Value Framework. And it was developed primarily as a physician-guided tool to facilitate shared decision making by patients and their oncologists as they select among high-value treatment options for individual patients. In our framework, the clinical benefit of a specific treatment and its known toxicity are combined, and they produce a score that we call the Net Health Benefit. So after years of building, testing, and refinement, we recently conducted an analysis that compared the output of ASCO's Value Framework against the European Society for Medical Oncology, or ESMO's tool, which they call the Magnitude of Clinical Benefit Scale. Dr. Schnipper, you co-authored the assessment that we're going to discuss today. And that's why I'm so delighted to welcome you to the podcast. I want to thank you, in advance, for sharing your insights with us here today. Thanks for joining us. Dr. Lowell Schnipper (LS): It's my pleasure to join you. This is a terrific opportunity to explain a bit about what ASCO is doing and put it in the context of what other groups are doing, in particular, a group like ESMO. We started this effort, as you were pointing out, approximately a decade ago, not the Value effort, but our emphasis, as a society, on the increasing cost of cancer care for our patients. And we wrote several manuscripts detailing the importance of doctors being sensitive to cost and, of course, providing the patients with the best opportunity for high-value care. As the years evolve, and some of the initiatives that you've already mentioned, Cliff, we felt it really important to develop a formulaic way of approaching how we, as an oncology community, might assess the clinical value of the drugs we use to treat patients with cancer and convey that, then, to our patients in the context of shared decision making. That's really the background of this effort. And the Value Framework itself has actually evolved over about three or four years in a number of iterations. And I'm hoping that as the discussion ensues, we'll be able to get into that in more detail. That's great. So let's actually start with the main topic today, which is the comparison between ASCO's work and ESMO's. Why, exactly, did you decide to pursue this comparison and then publish it? We became aware that ESMO was undertaking a very similar initiative, namely an attempt at developing an algorithm with which to assess the value, the clinical value, of oncologic therapies representing all of the European nations. That's about 27 nations. In parallel, but actually quite independently, we at ASCO were developing our own Value Framework. And as one can see when reading about either of them, in many ways, they're quite different. But they have overwhelming similarities, specifically based on assessments of how much good a given therapy does for the patient when compared with a control treatment and, of course, how negative any of the effects of our therapies are to that patient population. And we integrated that, at ASCO, in our Value Framework in a concept that you rightly referred to as the Net Health Benefit. Well, ESMO, we came to learn as we were readying to publish our framework, that they had worked on something very similar, looking at clinical benefit and toxicity somewhat differently. And they, of course, published theirs in the Annals of Oncology. And we published our framework in the Journal of Clinical Oncology. These frameworks were met with an enormous amount of interest by every component of the oncologic community. And by that I mean patients, of course, are exceedingly interested in this. And we can get, I hope, to the patient perspective in a little while. But in addition, manufacturers were quite interested in how we were going about assessing the products that they bring forth and we put into clinical trial. And of course, ultimately, the oncologist, him or herself, is the deciding factor in recommending or not recommending a particular therapy. So we elicited tremendous interest. And I didn't even mention the payer community which, of course, was very, very interested because of the rising cost of oncologic therapies. In fact, I will say that one of the motivating factors for the ASCO community, and I think for the ESMO community as well, is the awareness that oncologic therapies are very, very costly, sometimes eliciting huge out-of-pocket payments for our patients. And now, I speak for the American health consumer, not so much those in Europe. And this becomes a major factor in the patient's and the patient's family's well-being, as in this risk we know for financial toxicity. So we felt it very important to establish points of overlap and similarity, as well as points of difference with the ESMO framework in order to understand and improve each other's work. And so while we don't view this necessarily as a planned collaboration with which we'll modify each of ours after arguing about different points in a scholarly way, what we really wanted to do was see how each framework performs when looked at through the same lens of a number of trials. And so that led to this comparison of, well, we started out with over 100 trials and focused on 97 that were being done in a prospective randomized clinical trial context for palliative purposes, meaning for non-curative situations. And that really is the background of how it came about. CH: So before we dive into that aspect of the results, I think it might help to clarify, for just a moment more, the comparative effort on two planes. On the one plane, which you touched on, there is the actual design of the tool, what it takes into consideration, and what it weights. And on the other plane, there is how it actually evaluates specific treatment options. So can we just circle back, for a second, at a high level, what is it about the two tools that you would say is similar to overlapping? And what is it that is, perhaps, different, if anything, about the two tools methodologically? LS: Both tools are premised on using a prospective clinical trial in which a comparator is compared in a specific clinical disease setting, clinical cancer disease setting, with a test agent, or a test regimen. And so both of them look at that particular subset. And, in fact, that is the case for these 97 trials that I just alluded to. The ASCO clinical benefit, when comparing a test regimen to a control, is literally measuring the difference between the two in the hazard ratio, or the overall survival. So, for example, if the overall survival is measured in months, but no hazard ratio were given, if the overall survival for the control was 10 months, and the overall survival for the test agent was 20 months, in fact, we would register basically a doubling, or a very high degree of clinical benefit. And if the hazard ratios are such that there's a very low hazard ratio for death, meaning a high likelihood of survival, then the ASCO Clinical Benefit Score would register a large number, accordingly. Our attempt at finding, numerically, the difference between a clinical comparator and a test regimen differs from ESMO where they have reduced categorical differences. In other words, they ultimately arrive at a score of 1, 2, 3, 4, 5 rather than measuring the quantifiable difference between the comparator and the test agent. So we actually differ in how we go about defining the clinical benefit. We are trying to be a little bit more precise. And ESMO, I think, feels that that attempt at precision may not always be completely valid, because studies vary in terms of sample size and that could influence the variability around the mean or the median. So there's some technical differences, or biostatistical differences. But basically, we each are trying to develop a magnitude of clinical benefit and have done so in our frameworks. We differ from ESMO in the sense that we have developed a rather elaborate toxicity scoring system. And that's largely because we have, in developing the framework, interviewed many, many patients or leaders of advocacy groups. And they impressed upon us that it's not just grades three and four, or heaven forbid, grade five toxicity that worries them. It's often low level of chronic toxicity that also impacts on the quality of their lives. And we felt we needed to develop a tool that reflected the patient's perspective as it was explained to us. And so we have a much more elaborate, and I will confess probably more difficult to pull out of the literature and score, than the ESMO toxicity assessment in which they more or less say, this is highly toxic, not so toxic, or very minimally toxic. So we feel that we needed to do that and that it makes sense because it reflects our patient's input. And again, this is a tool we keep coming back to that's to help patients and docs make decisions. So those are a couple of the ways in which we actually differ appreciably. In addition, ESMO practically ignores progression-free survival, which, as you know, many, many prospective randomized trials use as a primary endpoint. I think we, at ASCO, completely agree it's not the very best surrogate endpoint. And as such, if [INAUDIBLE] namely, the better endpoint, is not the primary endpoint in a given trial, we will utilize the progression-free survival in our value assessment, but we actually downgrade its value. So, in other words, if the value of a score for overall survival as opposed to the value of a score for progression-free survival differs, we indicate it by about 20% less for progression-free survival. So the differences in the toxicity parameters we felt were important to maintain and the difference in the progression-free survival measurement, or I should say downgrading its importance, that, too, was also difficult to at least-- well, I should say progression-free survival turned out to be a less valuable endpoint than overall survival. And we felt quite legitimized in reducing it. ESMO agrees, but they basically give very little credit for progression-free survival unless the improvement in progression-free survival is associated with virtually no toxicity. So we differ a little bit in that. But again, we're circling around the same sets of variables, but coming at them somewhat differently. CH: All right. So let's talk about the results for a moment. That background, I think, is really helpful to audiences who are trying to put these in context. But a couple of points that I would make, and then I have a question, or maybe one point I would make is, there have been a number of prior studies that have been conducted by external researchers. They've looked at and compared the two frameworks. And they reported lower levels of agreement between ASCO and the ESMO frameworks than you and your colleagues are reporting now. What's fundamentally changed? I mean, how was your analysis performed? And why does it show a greater degree of concordance than earlier external investigators found? LS: I'm glad you asked that. That's a key question. And of course, we were initially kind of dismayed when we saw published results in which there was some degree of disagreement between the ASCO and the ESMO scales. Well, it turns out that there was one, out of about four or five that were in the literature, that actually found a high degree of concordance, although it looked at a relatively small number of trials within the same disease area-- lung cancer. So what we realized was that these are complicated frameworks to work with, that they're not trivial. And the reason I arrive at that is because we are blessed with a very, very bright, talented staff within ASCO who embraced the task of applying our Value Framework to these 103 trials. What we learned is that for people who weren't involved in generating the framework, but were called upon to apply it, they literally had to get onto a learning curve in order to produce consistent assessments after culling out the relevant data from a given paper. So we are pretty sure that the low levels of concordance really had to do with people misapplying the scales in many, many cases. And the proof of the pudding, I think, is in the eating because while we didn't find perfect concordance, and that gives us additional food for thought, we actually did pretty well, because 65% to 70% of the trials actually came out with an agreeable scoring, meaning that what ESMO concluded was reasonable to recommend incorporating into a European nations Pharmacopoeia for cancer drugs, represented the upper half above, let's say, a Net Health Benefit score of 45 for ASCO. So those 65%, 70% of trials actually scored pretty much concurrent with one another in terms of identifying drug regimens as useful. The outliers, those that differ, were actually another cause for our scratching our heads and, ultimately, teasing apart the differences. And we do understand some of the reasons why the scales are different, which isn't to say one is better than the other, but it probably just rests on bedrock assumptions in terms of incorporating various variables into the Value Framework. CH: So that's great. A couple of follow-up questions, I suppose. And I'm just curious, either from the ASCO side or, if you know, from the ESMO side, based on this effort to compare them, is there any plan to actually tweak them to increase their alignment? Or is everybody happy that they're each fulfilling their planned functions and this little bit of discordance is OK? LS: That's a great question. I can say that, at the very start, this goes back a couple of years, I had meetings with counterparts at our annual meeting, or at the ESMO meeting, just talking about whether or not it would be desirable to essentially arrive at a transatlantic consensus of what would be thought to be a clinically useful addition to our Pharmacopoeia versus not. And I think we are all motivated by exactly that, although I think we don't necessarily have a plan at the moment to try to develop a single uniform framework, at least not for the foreseeable future. And the reason for that is that we are trying, in the US environment, to utilize our framework in some of the organs that we, as oncologists, typically go to in order to assist with clinical decision making. And so here, I'm referring to the JCO when we publish prospective randomized trials or, for that matter, other high-impact journals like New England Journal of Medicine or perhaps JAMA. We would like to actually begin a catalog of ASCO Value Framework Net Health Benefit scores as these trials accumulate over the next 6 to 12 months. And that's because we'd like to actually get a feel for that which oncologists are comfortable using and recommending to patients and how our Value Framework stacks up against that. We're thinking that that could be a very, very helpful way of us understanding if we're throwing fastballs right over the plate, or are we missing the mark sometimes and do we need to make some mid-course corrections. And as you can imagine, the Value Task Force, at the moment, is viewing where we are with the framework as pretty far down an iterative process that's not yet complete, because we need to incorporate this assessment into the real oncologic literature, see how well it performs with what doctors think and patients think are useful drugs. And at that point, I think, we'll be able to utilize it more effectively. The other thing that I will say that we need to do, and we already have a sub-task force or a subcommittee working on this, is to essentially address the issue of, in breast cancer or in colorectal cancer, if there are three or four trials for a given specific clinical scenario, but each is using a different comparator, a different control, can they ever be compared if the test agents are the same, or the test regimens are the same? And the answer is, of course, they really can't because you can't easily do cross-trial comparisons. And so we have been working with methodologists who are advising us on doing network meta analysis, a way of at least statistically looking at trials in the same patient population testing the same regimen or novel agent, but if using different controls, to essentially come up with what amounts to a reasonable sort of summarize, or summative control, against which we can then look to see how impactful a new therapy is or is not. Statistically, it's never all that pleasant, as you know because you're a very experienced investigator, it's never all that easy to even think about cross-trial comparisons. But rigorous statistical techniques, I'm told, are available to at least help us do that. CH: Yeah, it's interesting. There's a little bit of overlap with the synthetic control arm discussions we have in the context of CancerLinQ. But that's probably a topic best left for another day. I want to come back, though, to a core issue that I think circles all of our discussion and that is financial toxicity, which you raised earlier. And very specifically, in your dreams, how do you see that this process, both our tool and ESMO's for that matter, how do you see them actually having an influence on drug price, which is, I think, fairly summarized as the elephant in the room here? LS: I'm glad you asked that, but I continue to struggle with what I would think would be an acceptable answer in its broadest dimensions. But my sense is the following. There has been incremental improvements in cancer therapy from the very start of our field. And you'll remember in Charles Moertel's work, the increment of 5-FU in colon cancer was trivial, a few months. But now we know that patients with metastatic colon cancer can survive for 27 months, on average, perhaps more in many cases. So how do you judge incremental benefit? That becomes a real thorny, almost a societal issue because therein lies the rub. We know our patients are being almost asked to pay out-of-pocket quite a substantial sum for many of the novel drugs that we have. Some of them, you and I would absolutely agree, are a slam dunk benefit. But we know, as well, that there are many that add very, very small degrees of benefit in comparison with a much more affordable, perhaps generic drug, or set of drugs. What I have hoped for is that if we arrive at what our peer group, the oncologic community and patients, feel is a credible value framework that market forces will be able to get to work and actually modulate what the price that's being asked for a given drug. And that really goes back to the first thing we wrote in 2009 when we issued a guidance statement from the founding members of the task force. And that is that we recognize that oncologic drugs and, in fact, health care, in general, is not a market in the usual sense of the word. And the fact that it is a perverse market makes us worry, if ever, we'll get to a point where if we can show value, that will be reflected in the cost of the drug. If you have an innovative drug that is a slam dunk, like trastuzumab, of course, that should have and merit lots different value than a drug that has a very small incremental benefit. And how that can be reflected by a value framework influencing a real world market scenario I'm hopeful about, but I don't quite know the path to get there. CH: Yeah. I think that's actually a great summary of the frustration that so many of us feel as we think about how rational market forces should work and then what we actually see in our reality. So thank you for at least trying to put this in perspective. Thank you. It's been my pleasure to participate. And I'm really happy that ASCO is producing vehicles like this to broaden the understanding of the efforts that we're undertaking. As we wrap up, I want to just remind our listeners that the joint Value Framework assessment that we've been discussing is available online. You can find it at ASCO.org/value. And the ASCO Value Framework is, again, as I said in the introduction, just one part of ASCO's broader and multifaceted effort to help all of our members, and everyone, achieve high-quality, high-value care for people with cancer. The other efforts that we touched on before and you hear about in the podcast series at various times are the Patient-Centered Oncology Payment model, the Choosing Wisely campaign, CancerLinQ, and ASCO's QOPI, or Quality Oncology Practice Initiative. For more information on any, or all, of these initiatives and for the latest cancer policy news and updates, I ask you to visit ascoaction.asco.org and you can find links out to these programs and more there. Dr. Schnipper, I want to thank you again for joining me today for this ASCO in Action Podcast . And for everyone listening, until next time. Thanks for joining us.

Subscribe to the podcast through iTunes and Google Play.    Dr. Clifford A. Hudis: Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Ned Sharpless, the director of the National Cancer Institute. The NCI is the largest funder of cancer research in the world, and it has helped to drive many of the major prevention and treatment advances we've seen over the past 50 years. This includes things like HPV vaccination and the identification of the link between HER2 status and breast cancer outcomes and treatment, as well as new discoveries that have dramatically improved outcomes for childhood cancer. Dr. Sharpless, welcome, and thank you for joining me today. Now, we really have a whole lot to discuss, but before we get to our planned topics, I have to jump ahead and start with the president's State of the Union address, when President Trump mentioned that he wants to see $500 million appropriated for childhood cancers over the next decade. Can you talk a little bit about how you expect that, specifically, to play out? What will the NCI be able to do with those new specified funds for pediatric research? Dr. Ned Sharpless: Sure. I think childhood cancer-- childhood cancer is an area where the National Cancer Institute has had a long interest and a robust portfolio of research. And I think it is an area where we've made some progress, in terms of mortality, over the last few decades. But you have to say two things about childhood cancer. While progress has been good, and we're making-- more kids are surviving cancer therapy today than ever-- there's still a long way to go. Too many kids dying of cancer in the United States, and even the kids that we're able to cure have these significant lifelong survivorship challenges, in some cases. So the therapy that is curative may leave patients with side effects of surgery and chemotherapy and radiation for the rest of their lives. So better treatments for kids and less toxic treatments for kids are what we are really looking for. And with that amount of money, I think a good-- the thing that it appears to me that one could do to most quickly move the needle in childhood cancer-- which, as you know, is a collection of less common cancers, even rare cancers-- is really a more intentional effort at aggregating and using and linking clinical data with molecular data and other sorts of patient data, so that we can really learn from every child with cancer in the United States, so that we can really figure out what's working in certain populations and then disseminate that information as rapidly as possible-- without having, in all cases, to rely on slower clinical trial structures that are challenged for certain populations where accrual can be difficult. So I think that is the vision for the president's initiative, is to, with additional funding, allow for very aggressive, intentional, and organized data linkages and data aggregation so that we can learn from every trial and therefore treat every child's cancer in a better, more effective way. Dr. Clifford A. Hudis: You know, I think that's great. And that actually provides two different segues-- one I'm going to pick up right now, and one I want to come back to. The first is about data-- big data, specifically. We'll come back to that. The second is about the way the pediatric oncology community for years has really led in designing studies that could accrue the majority of children diagnosed with various specific diseases. And that leads me, that idea of eligibility and the structure of research, to ask about the way that you're thinking about modernizing clinical trials. This is something I know you wrote about in JAMA Viewpoint in the last couple of months. You addressed financial pressures, the need to increase overall rates of accrual to the trials, especially representing patients from underserved populations. Can you expand a little bit on that effort and what kind of progress you see as possible in the coming months and years? Dr. Ned Sharpless: Yeah, I think everything we do successfully in cancer today is in some ways the results of a clinical trial. And this is clearly one of the most important things the NCI does, in terms of moving basic science into patient care through experimental clinical trials. And it's an area where we-- frankly, a lot's changed in the last couple of decades. When I was a wee fellow, the clinical trials apparatus was very different from the way it is 20 years later today. And we need to make sure that we modernize the clinical trials process to keep up with the changes in our understanding of the biology and the new kinds of therapy we have for cancer. So that brings up a bunch of items that are areas where the NCI is really doing a lot of things. So, for example, one of the first problems I noticed when coming to the National Cancer Institute was that the clinical trials infrastructure, the big networks that we have for doing these kinds of trials, were under-resourced, that they had a funding problem. And they were becoming non-competitive with the trials sponsored by industry. And this showed itself in many ways, in accrual fees for patients, or the wait times to get the trial open, or the slow accrual once the trial was open. And so they were laboring under a number of problems. And so we decided we had to invest in the Clinical Trials Network and have been doing that and will be continuing to doing that in a number of ways-- through direct funding to attempt something like the National Clinical Trials Network or the NCORP, for example, the NCORP organization, but also by additional funding for biobanks and data aggregation initiatives, targeted clinical trials, et cetera. I think we've also-- there are some structural problems with the clinical trials that you alluded to. For example, eligibility criteria, I think, hadn't really kept pace with modern clinical trials. And I think ASCO and other groups have played a really important leadership role in identifying what are good eligibility criteria and which ones are not as necessary anymore. And then, do we have to have the same criteria in all the trials, and be more thoughtful about how those are used as a way to enhance accrual, because often we have a-- superfluous eligibility criteria can limit accrual. And increasing accrual by a variety of measures is really important. And we've thought a lot about how to do this through novel ways of clinical [? house ?] matching. I think one of the more successful efforts we've had in clinical trials accrual recently has been the MATCH trial, the NCI MATCH trial, which was able to accrue 6,000 patients at 1,100 sites in the United States, filling a targeted accrual two years ahead of schedule. It's the fastest-accruing trial in the history of the NCI. And I think one of the things MATCH teaches you is that if you have an interesting trial that's written in a nimble way that is open in the community-- that patients don't have to drive six hours to a cancer center, but can go to a local NCORP site, for example-- then those trials will accrue. We can accrue quickly, and we can accrue underserved populations, and we can accrue rare cancers. And that framework is more nimble than, say, the large phase III randomized trial run only at cancer centers that we had 10 years ago. There is still a role for large, randomized, phase III trials. The NCI is not backing away from that, or where we will support those. But I think, as we discussed in the JAMA piece, we really have to be thoughtful about where the NCI needs to be involved with those kinds of trials, compared to which of those should be supported by industry, for example. Dr. Clifford A. Hudis: It sounds like you're alluding to something I think you and I discussed even when you first got into your current role, which is the identification of those trials that industry should run, essentially, itself, and those trials that the NCI should support as complementary to industry trials. Can you expand a little bit on how you see that distinction and where you draw that line? Dr. Ned Sharpless: Yeah, the thing to know about clinical trials in oncology in the United States right now is most are actually paid for by industry. There's a huge pharmaceutical industry spend on clinical trials, and from my point of view, that's great. The fact that industry is paying for trials to develop therapies for cancer patients-- that's less money the NCI has to spend on those same questions. So we think that's a wonderful development and healthy for cancer research. But if that's the way it's going to be, then the NCI has to ask itself-- for the precious moneys that we have to spend on clinical trials, we need to use those in a way that's maximally effective and, in particular, not duplicative with what industry sponsors are doing. It's important to say, we do a lot of work with industry. So it's not just us either-or. Many of our trials, through these agreement processes called CRADAs, allow us to do trials with pharma sponsors and use their compounds in our trials. And that's a real boon to our research effort, as well. But there are certain kinds of trials that are very important where we really want to know the answer, but they're a bad fit for what industry is going to fund. For example, a de-escalation trial-- that's a trial where there's a standard of care that's pretty good, but the therapy is toxic. And so we'd like to see if we can get the same good outcome in a population using less aggressive therapy. A very important example of this was the TAILORx trial recently, where we showed that based on a genetic risk score, an RNA-based risk score of the breast cancer, women with estrogen receptor positive breast cancer-- many of them could forego cytotoxic chemotherapy and just take anti-hormonal agents and have the same good outcome in terms of their long-term survival. So that's a trial that is not going to be industry-led, for a variety of reasons. But I think it is the kind of question that's really important for patients. It's important, also, to say that de-escalation trials are hard to do. They require a lot of thought. They don't always work. And so they require these comprehensive thoughtfulness and infrastructure that the National Clinical Trials Network can provide. So an additional example is these multi-modality trials we have, where maybe two different agents come from two different pharmaceutical companies, and then there's some surgery and some radiation. There's very complex, multi-integrated care. And those can be very hard for a single sponsor to run, but, again, can be a very good fit for the NCI. And there are many other examples like this. But I think the real question we have to ask is, if our budget is limited and finite, what are the trials that the NCI really should do and lead on? Dr. Clifford A. Hudis: Yeah. And I think one of the points there is you need to conduct-- we need to conduct-- trials as efficiently as possible, getting the most so-called bang for the buck. You alluded to the fact that the NCI, along with ASCO, has been working on making trials essentially more efficient by making them more representative of the actual cancer population we end up treating. And a specific area of focus for us at ASCO, in this collaboration and also in our TAPUR trial, has been driving the eligibility age down below 18. My understanding is that this is something that you're adopting as a recommendation across the NCI, as well. I guess my question is, how broad and how quickly do you expect to see this implemented? Dr. Ned Sharpless: We have a number of efforts related to these barriers to accrual. You mentioned age as one of them and other sorts of exclusion criteria. And we've looked deeply and thought about this sort of care across the continuum of life-- both age limits on the less than 18 side, but also at the greater than 65-year-old side, where we see, often, eligibility criteria structured around a maximum age that don't often make a lot of sense. So that is one of several topics that we are addressing. As you know, we have a variety of networks and programs, and we fund a variety of kinds of trials. Some are led predominantly by the academic institution. Some are led through NCI networks. And so we are rolling out these policies, not in a one shot fits all way, but across these networks at different scales. They often require scientific buy-in from the other participants, and you know how that process works. I think this is an area, fortunately, where there is a lot of buy-in, where we're not having lengthy debates about whether or not we should do this. Really, the question is how we operationalize it and make it happen as quickly as possible. Dr. Clifford A. Hudis: That's great. And you know how strongly supportive we are, on lots of levels, for this effort and the related ones, in terms of barriers to accrual. I want to pivot, though, back to something that you introduced earlier about the big data. And my understanding is, in the annual plan and your bypass budget for 2020, you specifically called out the need to harness big data to speed up all of our work across the cancer research enterprise. And there are many companies, organizations-- we ourselves at ASCO have CancerLinQ-- that are involved in trying to collect data, share it, analyze it, and advance science and clinical care. But what exactly do you see as the NCI's role in facilitating this, and what do you think is our biggest challenge going forward? Dr. Ned Sharpless: Yeah, it's an interesting topic. I think the-- it's maybe two things to say off the top about big data in cancer research. The first is the NCI already has one very important example of how big data can transform a field, and that's The Cancer Genome Atlas, which later became the Genomic Data Commons. This is petabytes of genomic data that we make available in the cloud now to any researcher, basically, who is interested in cancer. And that set of data has led to thousands of papers and just a fundamental reorganization of how we think about cancer biology in many ways. And it's been a huge success, I would argue, and well worth the investment of the NCI to do it. And the data has been used in ways we never envisioned. We never thought of some of the papers and applications that would come out of the analysis of the Cancer Genome Atlas, for example. But the problem, then, one quickly sees, is that while that data set is great, it's limited. It doesn't have the clinical data, it doesn't have radiology and histology, it doesn't have-- we don't really have a way of binning big epidemiologic cohort data, for example. So the GDC, the TCGA, the Genomic Data Commons, proves how useful these kinds of data aggregation efforts can be, but also makes very clear what the shortcomings of our modern efforts are. The second thing to say is that this is a problem where the NCI is well-poised to be a leader, right? There are a number of issues around data sharing and data aggregation that really benefit from a Switzerland-like federal entity, a non-conflicted, dispassionate entity like the NCI that just wants to create the data structure in a way that's maximally beneficial for everyone, so that there are-- this is an area where the imprimatur of the federal government really allows us to play a role that would be hard for other groups to take on directly. And so I think this is a reason why so many groups have been looking to the NCI for leadership on this topic. So what are the challenges to big data? Well, I think that one challenge that has been spoken about a lot publicly is this issue of data hoarding by scientists and physicians and people who have these sets of data they don't want to share for academic competitive reasons. That is a problem. I'm not going to say that doesn't exist. But I don't actually think that's the biggest problem. I think a bigger problem around data sharing is just it turns out to be really hard to do. And by hard, I mean expensive. It turns out to be-- these various data sets were not created, initially, with the intent of sharing them. They're often in different formats. They're often governed by different kinds of data use agreements, which are governed by the consent form that the patient signed to have their data included. And so linking them can be both very technically difficult, from just a computer science point of view, and can also provide a lot of administrative and logistical hassles from the data sharing, data use agreement point of view. And so each one of these things is just something the NCI has got to work through, or someone like the NCI-- is figuring out how to link disparate data sets, how to get the right kind of data abstracted from charts that we want, how to develop the right work force to study big data with big data analytics, and then that is a big problem. So there are a number of areas where the NCI can address the challenges. And I think we'll make progress. I mean, the good news is that we understand these problems. This is not like we need to-- there's some fundamental problem of biology that we need to figure out. The bad news is that the problems are weedy, complex, and many, many layered, and require us working through them. But that's what we can do. We have support from the government for this. The moonshot had a lot of funding for data initiatives, which we've been employing to get these structures going. And now the Childhood Cancer Data Initiative, for example, I think could really-- that's a nice demonstration project, if you will, because it's the right size. Childhood cancer is about 16,000 cases a year. And so I think we can show what this radical data sharing, if you will, this data liberation project can do-- you know, that population and how useful it could be to larger groups of patients like lung cancer, breast cancer, things like that. So I think that these are the kinds of things the NCI can do with help from other federal agencies and academic partners and groups like ASCO. This is certainly not an area where we plan to go it alone. There are a lot of stakeholders and a lot of great ideas. And I think that by organizing and convening these initiatives, we'll make progress. Dr. Clifford A. Hudis: Well, I really, first of all, appreciate your calling out the fact that data hoarding in isolation is not the single biggest problem, because I think that's a frequently-cited limit. And I agree with you that it's less of an issue than all of the other ones that you highlighted. In that regard, I understand that you just announced a new office. I think it's the Office of Data Sharing? Can you expand on or explain how that relates to these challenges and what it's going to, hopefully, accomplish for us? Dr. Ned Sharpless: Sure. The Office of Data Sharing is something within our Center for Bioinformatics and Information Technology. It's getting stood up now. It's been around for about a year, even less than that. It has a new leader and a few FTs, and it has a number of jobs intended for it. I mean, there are a number of ways that we would like the Office of Data sharing to-- a number of problems that we think that the ODS can help serve with the external community in terms of data sharing, like these issues around consent and data privacy that I mentioned. But right now, an intense focus of that office, because it's something we really need to solve, are related, really, to the issue of accepting data and allowing access to NCI data at present. So we have this complex structure whereby academic investigators can give data sets to the NCI. That's harder than it sounds, because we have to make sure the data are of good quality and they're properly consented, and we understand the data usage agreements and that kind of stuff. And then we have a means to allow access to those data to accredentialed investigators. And there are a bunch of issues with that that are more complicated than you and I would want to go into right now. But I think that's consuming a lot of the bandwidth at that office right now, is the problems around, for example, the dbGaP entity, whereby different investigators give data to the NCI and the rest of the NIH. That has caused a bit of a bottleneck, and so we're trying to work through some of those issues. One thing, for example, that I think the ODS can do and is doing already is this sort of concierge-like function. For people who have large, valuable data sets that they'd like to give to the NCI, we should be able to take those data sets as quickly as possible. But something that's happened in the transmission of those data is that we've realized the quality isn't quite what we wanted or the format isn't exactly right, and so we have these questions, and they go back to the investigator. And there's this sort of cyclical loop that can take months and really substantially delay the process. And so the ODS is jumping in there early on and intervening on that loop and making sure the data are the right format and the right quality at the time of initial submission, so that we don't have this back and forth that wastes a lot of time. So I think those data access and data transmission issues are a prime focus for the office right now, although it has a much larger mission as it gets stood up. Dr. Clifford A. Hudis: Yeah, a little bit like CENTRA that Rich Schilsky runs for us here at ASCO, in terms of access. But at any rate, I want to take the remaining time we have, and maybe this is a speed round on the cancer research workforce. So a couple of quick questions, perhaps-- first of all, has the Cancer Moonshot Initiative had an impact directly on the kinds of awards that you're making available to researchers? And if so, how do you think that might evolve in the next couple of years? Dr. Ned Sharpless: I think the moonshot, as you know, was intended to focus on these 10 areas identified by a blue-ribbon panel that were thought to be ripe for clinical translation, just about ready to go into clinic and to benefit patients in a very direct, immediate way. So the moonshot per se didn't include funds for things like really hardcore basic science or training, although certainly moonshot moneys are being used to some extent in both those areas, as necessary, as part of these translational efforts. So I think that what the moonshot has done-- it's done a couple of things. So first of all, that most of the awards granted by the moonshot mechanisms are more these-- are not the traditional R01, but are more of these consortia and network grants. And I think we've built a lot of infrastructure for research efforts, say, in immuno-oncology or in pediatric cancer or in survivorship. And those networks will both-- well, they will live on beyond the moonshot in some cases, I'm sure. And those networks will provide integrated research efforts, but also some training opportunities. So most of those include junior scientists and junior clinical investigators, and so there will be some opportunity for the moonshot both to drive the scientific area of study and also provide some training opportunity for the new people coming up. Dr. Clifford A. Hudis: Well, speaking of junior and new, I listened to your conference call, I guess, about a week or two ago talking about the pay line. Can you expand on your plans to support young investigators right now, given the always-present constraints in funding? Dr. Ned Sharpless: Right. This is a particular problem for the National Cancer Institute, because we've seen this relatively-- there's no other word than "massive" influx in the number of applications for the so-called R01 grants, the independent investigator-initiated award at the NCI. And this is-- our award number is something up like 60% over the last nine years or so. So this rapid increase-- which is, in most ways, a very good thing. I mean, that says that new scientists are coming to our field with new ideas and new ways to treat cancer, and the NCI can pick among these many applications and fund the very best ones. But it has this pernicious bad effect for the academic investigator community, and that is that their individual chances of getting a grant are lower. If paylines are really the number of funded awards divided by the number of applications, and the denominator goes up faster than the numerator-- both are going up, but the denominator goes up faster-- then the paylines are going to go down. And we think this is particularly a problem for junior scientists, because established scientists have seen paylines come and go and funding realities change. But new scientists aren't as used to the life of the independent researcher and, we think, are most likely to either leave science or move out of cancer research to another area of science. And we'll have to try and minimize that from happening, to the extent possible. So one of the things we've done at the behest, in fact, of 21st Century Cures, which included language asking the NCI in the United States to do this, was really focused on these so-called early stage investigator, the ESI. So the ESI is faculty. That's someone who's gotten a job, generally in an academic institution, and is now writing their first R01 grant, their first independent scientist grant. And we've done a few things for this population. One thing that's really important is we give them a special payline. We give them, effectively, a higher chance of getting funding. So if, say, paylines are on the order of 8% now for all Comer grants, for ESIs they'll be more like 14%, right? So a significant-- or 12%, in that range. So, significantly higher than what the general community is. I want to point out, also, that paylines are lower than the actual success rates of the NCI, which is a better number. The reason success rates are higher is because we do fund a lot of grants outside of the score. It's a little bit of inside baseball. But generally, if you write a grant to the NCI, your chance of getting it is more like 12%. And if you're an early stage investigator, it's more like 16%. Dr. Clifford A. Hudis: Thanks, Ned. To switch gears a bit, I know you've worked with the NCI throughout your career. But now you've been at the Institute's helm for nearly a year and a half. Has your understanding of the NCI and its role in cancer research changed or evolved in this newest assignment? Dr. Ned Sharpless: I think it has to be said that I was an NCI watcher my entire research career, and I thought I knew the National Cancer Institute and the National Institutes of Health pretty well-- as well as one can know these organizations from the external perspective. But since starting at the NCI, I've really learned that this amazing organization is much larger than even I realized, and that the scale and scope of the NCI is truly both awe-inspiring and, in some ways, daunting. I had a series of meetings as I started as NCI director where I would learn about these sprawling comprehensive cancer prevention and control efforts or new areas of basic research or clinical trials. And I just really had had no idea that the NCI was involved in some of these activities. So it was very illuminating. In some ways, it's thrilling, the things the NCI is doing. But I think it also made very clear to me another thing that I think I knew at some level, but didn't really appreciate the full scale of this until becoming NCI director, and that's the issue of-- although the NCI is huge and has this great reach and comprehensive nature, we are limited in scale. Our resources are finite, and the NCI, therefore, is really forced to make these difficult choices about which areas of cancer research to fund and how best to address our mission of reducing cancer suffering. So I think I was surprised both by the scale and scope of the NCI, but also by the fact that, despite how big the NCI is, it still has significant limitations on what it's able to do and has to make these difficult choices. Dr. Clifford A. Hudis: ASCO recently launched the "I lived to conquer cancer" awareness campaign that spotlights federally-funded cancer researchers and the patients who inspire them. I want to close out our conversation today by asking you, why do you live to conquer cancer? Dr. Ned Sharpless: Yeah, I think like just about everybody in the United States, my life has been personally touched by cancer. I've had friends and family members get cancer, and my father even died from cancer. Both of my sisters are cancer survivors. So I think I have a real personal stake-- like everyone in the United States, almost-- in seeing the reduction of cancer suffering and conquering cancer, if you will. I also find the problem fascinating from an academic point of view. I was drawn to cancer research because I found the biological questions of cancer research so fascinating. So I live to conquer cancer from this intellectual point of view, as well. And lastly, I have the experience of being a doctor, of being a medical oncologist taking care of patients with cancer. And I've had the frustrating experience of having patients not do well who I thought, I wish we could have done more for-- as well as the experience of taking someone who has a pretty terrible cancer but yet driving it into remission with therapy and then watching that person effectively survive the disease and become cured of it over years. And that is so special and so thrilling to be a part of that as a physician. So I live to cure cancer because it's personally touched my life, because I am a scientist who is fascinated by the biology of cancer, and as a doctor I've had the experience of helping people survive their cancer. And once you do that once, you just want to do that over and over again. Dr. Clifford A. Hudis: That's really great, Ned. It's fascinating to hear why progress against cancer is personally so important to you. And I'm sure all of our listeners enjoy hearing that, as well. I want to thank you again for joining me for this ASCO in Action podcast and for all the work you do at the NCI and across the entire cancer care community. Well, thank you for having me. As you know, one of NCI's most important partners in this effort against cancer is really ASCO. And so it's great to speak to you today. And thanks for all the things that you guys do for patients with cancer. Again, thanks to all of you for listening today. Those of you who want to follow Dr. Sharpless on Twitter, he's @NCIDirector. And you can always follow me @CliffordHudis, as well as ASCO @cancer. If you do that, you can stay connected to our work, of course, on social media. You can also go to the NCI's website, which is NCI.gov. With that, again, I want to thank Dr. Sharpless for joining me today. And thanks to all of you for tuning in.    

Subscribe through iTunes and Google Play. Don’t Miss: Exclusive interview with FDA Commissioner Dr. Scott Gottlieb by ASCO CEO Dr. Clifford A. Hudis on the next ASCO in Action Podcast, coming January 29. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.  This is Cliff Hudis, CEO of the American Society of Clinical Oncology and host of the ASCO in Action podcast series. For our next podcast I will be speaking with Dr. Scott Gottlieb, Commissioner of the United States Food and Drug Administration. The FDA plays a critical role in delivery of high-quality cancer care by reviewing and approving new cancer treatments. This discussion is sure to be very interesting. It’s going to highlight what the FDA is doing to modernize clinical trials and expedite drug development, and with all of that I urge you to tune in for upcoming information about this special AiA podcast with Dr. Scott Gottlieb.  

Disclaimer The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.     Dr. Clifford A. Hudis Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, of course, the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to have as my guests - and you heard that right, plural - Doctor Ed Balaban, one of ASCO's delegates to the American Medication Association House of Delegates and Doctor Kristina Novick, an alternate delegate to the AMA House of Delegates. Both Dr. Balaban and Dr. Novick recently represented ASCO at the AMA House of Delegates meeting where they advocated for cancer policy priorities. During our conversation today, we'll get an update on the AMA meeting, we'll hear more about some of the key issues that we discuss, and then we'll spend some time talking more broadly about ASCO's role at the AMA. Dr. Balaban and Dr. Novak, welcome, and thank you for joining me today. Now, let's start with a general overview of the AMA House of Delegates, what this governance body is and why, as a medical specialty society, ASCO should care about its activities. Dr. Balaban, you have served for many years as an ASCO delegate to the AMA House of Delegates, and I want to take this opportunity first to thank you for that service. But second, I want to ask you what exactly is the role of the House of Delegates? And how does it influence what the AMA actually does? Dr. Edward Balaban So Dr. Hudis, thank you very much for inviting both Dr. Novak and myself to speak for a moment about this because it is something that I don't think that the general membership really understands or appreciates. So the AMA House of Delegates, it's an amazing collection. It's also known as the House or the HOD, and it turns out to be the principal policy-making body of the AMA. It is in a democratic forum that represents views and interests of a number of member physicians and, in fact, represents close to 170 or so societies. We meet twice a year, and the whole idea of meeting is to eventually establish policy in medical, professional, and governance matters that have to do with the AMA business activities and principles of the AMA. Dr. Clifford A. Hudis And how many members are there? And exactly how are the members selected? Dr. Edward Balaban So the delegates right now-- and I say right now because it does change based on the number of AMA members within each representative society. But right now, the delegates number around 620, I believe. ASCO, right now, we have six delegates. Three of them are full delegates and three are alternate delegates. Dr. Clifford A. Hudis All right. So ASCO has three delegates who are appointed plus three alternate delegates. Is that right? Dr. Edward Balaban That's right. The full delegates are voting delegates. And we'll get into the details of that, I'm sure. Dr. Clifford A. Hudis So what actually happens? You have 620 delegates get together. I assume you're in a big ballroom at a hotel in Chicago. And what exactly goes on in that meeting room? Dr. Edward Balaban So, again, we meet twice a year. We meet shortly after the ASCO annual meeting in June and spend a fair amount of time in Chicago then. And then we meet once again in November at another site. The meeting itself, each time, lasts maybe three or four days but the preparation for the meeting goes on for months. And in fact, Dr. Novak and myself and the rest of the delegation are beginning to think about November's meeting now. So the way this goes-- the way it all happens is a bit complicated, but it's fairly straightforward nevertheless. We as representing ASCO and I guess medical oncology come to understand some of the more important issues that are facing practice, no matter what setting it might occur in. Those issues then lead to crafted resolutions that are presented eventually to the House of Delegates. We go over them based on ASCO policy as well as the interests that lie within the delegation itself and frankly what we hear from the different committees within ASCO. As we're putting together resolutions, the other societies-- and again, there are a number of societies, 170, 180 societies. They're putting together their resolutions, too. In addition to that, problems that had been discussed in the past at the AMA that have made their way to the board or various committees, those reports are being formed. Dr. Edward Balaban And so there is a gathering of all those resolutions and all of those board reports that become available perhaps a month, six weeks, maybe eight weeks prior to the beginning of the meeting itself. Each one of those resolutions and board reports that are then reviewed in our case by ASCO and a staff. And oh, by the way, I should say right off the top that ASCO staff is superb, and nothing happens without their help. But we review each resolution that's pertinent to the world of medical oncology. We develop our own resolutions as best as we can. We start to share them with other societies that we feel might be interested. And then eventually, those are all submitted to the AMA and then we gather. The first day in Chicago or wherever we meet is usually sort of the time to start to politicking. And it really is in the truest sense that. We review those resolutions. We review our thoughts. Others meet us in hallways and meeting rooms and committee spaces that want us to participate and/or get our thoughts on different problems. Those resolutions then make their way to a panel where we testify for them. Either Cristina or myself or one of the delegation stands up and says, "This is what we have our concerns with from ASCO. We would like the AMA House of Delegates to think about this." Those resolutions are then thought through by a committee that is an aside committee. It's made up of maybe five or six people. And again, this occurs the day before the actual House itself meets in that big ballroom that you just mentioned. Dr. Edward Balaban That committee then decides, "Well, that resolution that Dr. Balaban just presented, that is already AMA policy," or, "That does hold some water," or, "We need to think about is whether we want to go forward with that or not." The following day, that is when we met in that big ballroom, a whole bunch of us. And it's all the voting delegates, the 600 and so, alternate delegates. There's usually a number of international organizations there. Press is there. Observers from around the country are there. And each one of these resolutions that need to be talked about are then brought forth. The debate sometimes can be very quick but sometimes, it could be fairly contentious and confrontational sometimes but fortunately, that's not always the case. It's done in a very structured, Parliamentarian way. And then at the end of all that, there is a vote that the AMA House of Delegates either accepts or rejects the particular resolution that, in our case, ASCO has presented or reaffirms it into data and/or policy that the AMA already has or wants to re-look at it and send it down the road to be looked at, again, at the board level or at some committee level to come back. Dr. Edward Balaban It all sounds terribly complicated. The business of the House of Delegates can spread over two or three days. It is always an amazing process with so many folks with so many different ideas. And you would think that at the end of all that that there has to be great chaos, but year after year, meeting after meeting, I'm always impressed how we walk away from there with a consensus. And it may not be exactly like you wanted but it makes sense at the end of all that meeting. So it is a complicated process. It's a difficult one to explain. It's a bit of a learning curve to be part of it but once you see it happen, you understand that something good has taken place. Dr. Clifford A. Hudis Well, that's great. We're going to come back a little bit maybe and talk about execution or implementation, what all of this leads to. But maybe first, I want to ask Dr. Novick-- first of all, I want to say thank you for joining us again today. Your role in all of this is as an ASCO alternate delegate. So tell us, what exactly does that mean? Dr. Kristina Novick Well, thank you very much, as well, for having me today. So I think as Dr. Balaban has explained is that ASCO's allocated three delegate positions and three alternate delegate positions. And together, we make up what we call the ASCO Delegation to the AMA. Being an alternate delegate allows me to participate in the House of Delegates and support ASCO's activities. We work together as a group often several months before the meeting to try to create a list of priorities that we can then formulate into resolutions. During that time, we're often working with other specialty societies that have similar priorities. We try to gain their support for our objectives. And likewise, they reach out to us to gain support for their objectives. We then create this list of resolutions that we submit for the meeting. And often, we end up reviewing probably over 100 to 200 resolutions just for each meeting. With the help of ASCO staff, we review these resolutions and we come up with position statements for the resolutions, especially when some of them are related to ASCO's priorities and policies. So as an alternate delegate, really, what I get is pride in being part of the medical oncology community and being an ASCO member. We're a small but mighty delegation. We only make up 0.5% of the delegates but we find that we have friends not only in the cancer caucus but also within other organizations that have similar priorities. And then we have the respect of the House representing our patients who are vulnerable in terms of their cancer diagnoses. Dr. Clifford A. Hudis So maybe you could expand a little bit and talk about what some of the policy priorities that we actually worked on to advance in the June meeting. Are there any specific ones that come to mind that you think our listeners should be aware of? I mean, I guess, for example, PBMs or 340B or opioids. Are any of those issues that you could illuminate for us? Dr. Kristina Novick We had a number of resolutions that we submitted this year. The ones that really do come to mind are, first of all, the pharmacy benefit managers resolution. We found that there was a lot of interest, not only from our organization and the experience that we've had within oncology with pharmacy benefit managers but also other specialties have also expressed frustration as to what has occurred with their involvement over time. In particular, ASCO's resolution asked for data gathering on the impact of the pharmacy benefit managers, on clawbacks in direct and indirect remuneration fees. The House of Delegates agreed with us on this and also wanted to gather data on the top 25 medical pre-certification requests with exploration as to what percentage of those ultimately were approved after physician appeal. I thought this resolution was really important because we know that pharmacy benefit managers, they end up controlling the drug benefits for over 210 million Americans, many of which are Medicare Part D participants as well. In addition, there were other resolutions that were focused on pharmacy benefit managers such as the state of Michigan was concerned about the regulation of compounded medications by pharmacy benefit managers and requested that the FTC and FDA get involved with increased regulation. And the board of trustees as well further outlined AMA's efforts to combat restrictions that were created on prescription and dispensing of opioid analgesics by pharmacy benefit managers and requested that we oppose their control of dose or duration limits on our prescription and on dispensing. Dr. Kristina Novick In addition, we also looked at the 340B program. I think that there's going to be a lot of interest in this as we try to further control drug costs. The 340B program, for those that aren't familiar with it, was a program that was actually created decades ago in an effort to try to increase the affordability of supporting patients who are underinsured or uninsured and have their access to medications that often can be quite expensive which is something that our patients in oncology experience quite often. Over time, the program's been used especially by large hospital systems as a way to try to increase the reimbursement that they receive for medications that they dispense to their patients. And we had questions as an ASCO delegation as to whether this was really going to the benefit of the population that it was originally intended for. So our resolution asked for increased transparency and oversight of the program. We believe that you need to use those savings in order to help the patients that are underinsured and most need that support. Ultimately, the AMA supported this but they also wanted to investigate our request that we no longer use the disproportionate share hospital adjustment to determine the eligibility. So we'll hear back from them in the fall of 2018 as to what the conclusions are of that report. Dr. Clifford A. Hudis So I think it sounds like these resolutions and some others that we were promoting were received favorably. I hinted though with this question a moment ago, with them passed, can you tell our listeners exactly what this means? How does the passage of one of these resolutions actually lead to a practical change in our environment? What happens next to make this part of our new reality? Dr. Kristina Novick So resolutions typically are either new policy or directives that take action. Essentially, new policy can be used to support further action by the AMA as issues arise within the legislature, within courts, within allocation of resources by the AMA which is a very large organization. They can also be used to help coordinate efforts by other organizations. The directives that take action are more specific, and the AMA will report back as to what actions they have done and also what they've achieved in response to those directives. So essentially, the House of Delegates, because it meets twice a year, directs these directives and the activities of the AMA. And in between the meetings themselves, the board of trustees acts as the body that will make the recommendations as to what the AMA needs to do to achieve the directives if there's any question in that regard. So what will happen from here is the board of trustees will be reviewing the resolutions that have been passed and then create the list of priorities and objectives to pursue over the next year. And the AMA has a tremendous amount of advocacy that it's able to do. But I think the most important thing that it can do is help coordinate these efforts across states, societies, across specialty societies which is something that we wouldn't be able to do just on our own. Dr. Clifford A. Hudis So the real boots on the ground as it were amounts to advocacy at the state and national level, talking to legislators, talking to regulators, talking for that matter I guess to other stakeholders in the healthcare ecosystem and trying to influence practical rules and regulation and policy. Is that a fair summation when it's all said and done? Dr. Kristina Novick I think that's a great way to summarize. Essentially, if you go meet with a legislator, it's very easy for them to dismiss you although we do have a lot of clout, I think, coming from the oncology perspective. But still, it's easier to divide us up into different specialties and say, "Well, psychiatrists want this and dermatologists want that." But when it turns out that we all share common objectives, we can approach them and say, "The medical community, this is what we want. This is what is best for our patients." It's a lot stronger, I think when it comes from that perspective. Dr. Clifford A. Hudis That's great. So before you go and I turn back to Dr. Balaban, I'm just curious as to what your perspective is on the fact that we have this very exciting, new milestone for the oncology community at the last AMA meeting and that was that Dr. Barbara McAneny was sworn in as the president of AMA. She's the first oncologist to serve in that role. What do you think that role means for ASCO and the oncology community? Dr. Kristina Novick We are very excited about Dr. McAneny taking over as president of the AMA. She certainly brings not only a medical oncologist perspective to the leadership of the AMA but she also brings the perspective of a physician who is taking care of underserved populations, who is a patient advocate before all else. And I think we're all going to benefit from that leadership that she's shown over the years in that regard. She's also been very good at being a role model in terms of how to practice medicine in a sustainable fashion which is something that we need. So I am incredibly excited about her leadership and her accomplishments of rising to this position within the organization. A lot of leaders within the AMA will come from large delegations. And as I said, we're not a large delegation. We're a specialty society that has three delegates spots, three alternate delegate spots. But the fact, I think, that we have now also as our advocate the president of the AMA, I think that there's going to be a lot of potential opportunities for medical oncology to get additional help from the AMA on our key issues and to be more involved as well. So I think it was very exciting to see her take that position. Dr. Clifford A. Hudis So Dr. Balaban, I know you've known Dr. McAneny for many, many years. And I was really touched and I thought it was a thought-provoking comment during her inauguration where, if I remember correctly, she made a plea to move away from the term providers. And I think it was a plea to focus really on physicians. I don't know if I'm misremembering that, but it struck me that it was an important semantic distinction. Knowing her, knowing her passion, knowing her years of service to the community, to ASCO, to her patients, what's your perspective on how she'll be different as an AMA president? Dr. Edward Balaban Like you mentioned, she's been involved with the AMA in every facet of the AMA, oh, my gosh, for years. And as Cristina mentioned, this is almost precedent-setting. Neither she nor I can remember a specialty society having a successful campaign for presidency. Barb did say exactly that. She moved away from the idea of provider because to her-- and I shouldn't speak for her but she has shared enough with me and with the AMA. Provider's sort of a tone of a definition that's part of the system. And when I say the system, I mean as it currently is in the medical community. Well, the one thing that she has proposed is that she would like to fix this system. And she'd like to readjust it, reset it, rethink it, re-personalize it that we are just not providers. We are the physicians. We are the people that drive it. We are the people that make those decisions that will make it flounder or be successful. So she has tried to reroute this, and she can do it because she does relate. As Dr. Novak said, she can communicate so well, whether it's the Navajo Indians in New Mexico or with the CEOs in Chicago. She has traveled all those different areas. Dr. Edward Balaban And she does not mince ideas or words. She'll say very effectively what needs to be done. And Barb and I, as with most people on the planet, we'll go back and forth on a number of things. But I could tell you that we're all very pleased to be, in a sense, on her coattails. But let me just add to that that when it comes to oncology patients, I have come to learn at the AMA that our patients and our problems tend to be first and foremost almost Barb will say a canary in a coal mine. Maybe it's with the expensive and difficult drugs that we use and the difficult diseases that we face and the multitude of problems that we do run into with each and every one of our patients, whether it's physically or economically or socially or whatever, we tend to run the tip of the iceberg. And so other societies, other world within AMA will come to see what oncology thinks. And Barbara represents a huge spokesman in that area. Dr. Clifford A. Hudis Well, that's really great. And I think that we're all excited by this turn of events and the unique opportunities that the year ahead will bring, and also I think the lingering impact in the years that follow we'll be able to have on the AMA. So with that, I want to again thank both Dr. Balaban and Dr. Novak for joining me today for this ASCO in Action podcast. For the listeners, I'd like to remind you that you can always learn more about ASCO's work with the AMA, and you can continue to follow ASCO in Action for news and updates. You can visit ASCO Connection to read great recaps of the meetings that are usually written by Dr. Balaban himself. And you can find them online at connection.asco.org searching for Balaban, and that's B-A-L-A-B-A-N. So until next time, thank you all for listening to this ASCO in Action podcast.  

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis discusses the recently released Medicare Physician Fee Schedule (MPFS) proposed rule. The MPFS is a complete listing of all fees Medicare uses to reimburse doctors and other providers and suppliers under a fee-for-service payment system.

In a new ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis highlights the newly launched ASCO campaign, I Live to Conquer Cancer, and discusses how ASCO members and the cancer care community can get involved. To join the campaign, visit asco.org/live-to-conquer-cancer.

In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.

With Congress having recently passed federal “right-to-try” (RTT) legislation, the latest ASCO in Action Podcast features ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky, FACP, FASCO, FSCT, who examines the issue and explains the difference between RTT and the Food and Drug Administration’s (FDA) expanded access program with podcast host and ASCO CEO Dr. Clifford A. Hudis.

Dr. Gary Lyman, MPH, FASCO, FRCP, joins ASCO CEO Dr. Clifford A. Hudis to discuss biosimilars and ASCO’s recent statement on biosimilars published in the Journal of Clinical Oncology. 

Melissa Dillmon, MD, chair of ASCO’s State Affiliate Council, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to examine current cancer-related policies that state lawmakers are considering and discuss how ASCO members can get involved.

In a new ASCO in Action Podcast, ASCO Vice President of Clinical Affairs Stephen Grubbs, MD, FASCO, joins ASCO CEO Dr. Clifford A. Hudis, FACP, FASCO, to break down the Quality Payment Program (QPP) and discuss the reimbursement changes coming to oncology practices in the United States.

In this podcast, we discuss studies on hormonal therapy for breast and prostate cancers, as well as two studies regarding other treatments for colorectal cancer and breast cancer highlighted at ASCO’s 2014 Annual Meeting.  Cancer Research News

Celebrating 50 yrs., the world's leading professional organization representing physicians who care for people with cancer, the American Society of Clinical Oncology (ASCO) has nearly 35,000 members worldwide. So, what is exciting in cancer research, and what are the critical challenges that need to be addressed in the world of cancer now and into the future? Guest: Dr. Clifford A. Hudis, ASCO Pres. (2013-2014) & Chief of the Breast Cancer Medicine Service at Memorial Sloan Kettering Cancer Center. Annual Meeting of ASCO, May 30-June 3, 2014 in Chicago, Il. Co-Host Dr. Peter Hofland, www.oncozine.com. Joni live M-F at 2:00 p.m. ET on www.W4CS.com. www.JoniAldrich.com

Host: Matt Birnholz, MD Joining host Dr. Matt Birnholz is special guest, Dr. Clifford A. Hudis, President of the American Society of Clinical Oncology (ASCO) and Chief of the Breast Cancer Medicine Service and an attending physician at Memorial Sloan-Kettering Cancer Center. Dr. Hudis will provide an executive summayr of the recently released State of Cancer Care in America: 2014 report, which will help cancer care providers, policy makers, and others more effectively shape the future of cancer care during these uncertain times. Download and listen to this update! And, to learn more about the websites that Dr. Hudis references in this interview, please visit: State of Cancer Care in America: 2014 report CancerLinq

Clifford A. Hudis, MD, Chief of the Breast Cancer Medicine Service of Memorial Sloan-Kettering Cancer Center and ASCO’s 2012-2013 President-Elect, explains why face-to-face networking and in-person meetings are important to oncology research, despite faster ways of information sharing. Hear what he told OT Assistant Editor Sarah DiGiulio.