"There are different types of advanced practice providers that you may meet in an oncology practice - PAs, APRNs, NPs, but what's the difference between them? In the second episode of ASCO Education's podcast series on Advanced Practice Providers (APPs), co-hosts Todd Pickard (MD Anderson Cancer Center) and Dr. Stephanie Williams (Northwestern University Feinberg School of Medicine), along with guest speakers, Leslie Hinds (Centura Health), Martin Clarke (Arizona Oncology), and Kathleen Sacharian (Main Line Health), break down the differences and similarities between physician assistants and advanced practice registered nurses, share what their days might entail in each of these roles in an oncology practice, as well as address some common misconceptions surrounding these types of APPs. Duration 35:52.

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TRANSCRIPT

Dr. Stephanie Williams: Hello and welcome to ASCO Education's Podcast Series Advanced Practice Providers, APP 101: Physician Assistants and Advanced Practice Registered Nurses in Oncology. I am your co-host, Dr. Stephanie Williams, with physician assistant, Todd Pickard.

Today, we are joined by Leslie Hinds and Kathleen Sacharian, both of whom are nurse practitioners, along with physician assistant, Marty Clarke. All three of today's guests are a part of the APP Task Force. Thank you all for being on our panel today. Leslie, Kathleen, and Marty, could you please tell our audience a little bit about yourselves, starting with you, Leslie?

Leslie Hinds: Good morning! I am a nurse practitioner in the Denver, Colorado area and I am in community practice.

Kathleen Sacharian: Good morning, everybody! I'm Kathleen Sacharian, and I'm an oncology nurse practitioner. I've had over 20 years of experience in both academics setting and community practices in the Philadelphia area.

Marty Clarke: Hello, everyone! I'm Marty Clarke. I'm in Tucson, Arizona. I've got closer to 30 years of practice in general medical oncology, as well as a fairly lengthy stint in cancer psychiatry. I'm also a clinical psychologist.

Dr. Stephanie Williams: Thank you all. Today's episode will be a deeper dive into the specifics of what physician assistants and advanced practice registered nurses or nurse practitioners do on a day-to-day basis in an oncology practice, as well as addressing some common misconceptions of what PAs, APRNs, NPs do in practice.

So, jumping right in, I'd like to ask you all to shed some light on the general differences between a physician assistant and an advanced practice registered nurse or nurse practitioner. Who would like to start?

Todd Pickard: I'll get the ball rolling. This is Todd. This is a great question. It's one that people ask a lot, you know, what is the difference? And honestly, in the clinical setting, there really is no difference.

When you see an advanced practice provider, whether they be an APRN or a PA, you're going to get the same kind of team-based care with quality and safety and that really focuses on the totality of the patient.

PAs and NPs arrive to their clinical work from different educational perspectives. But the work we do really is the same high-quality level of care. I'll defer to my colleagues to add some to that conversation.

Leslie Hinds: Yeah, I would agree with you, Todd, that in practice, NPs and PAs provide the same quality of care and the same type of care but our education and background is oftentimes different from a nursing role versus a medical role.

Kathleen Sacharian: I'll add that, you know, I think when we think about some of the main differences, really focusing, as Leslie said, like how are we prepared? How are we trained? A nurse practitioner is typically a registered nurse with a bachelor's degree and then goes back for a graduate degree in either a Master of Science in Nursing or a Doctorate in Nursing Practice. And typically, some of the main educational differences in a nurse practitioner role are that their focus in education is population-based, meaning it's based on a specific patient population or health condition. So, you might have an adult gerontology nurse practitioner or a pediatric nurse practitioner.

Marty Clarke: Kathleen, I have a daughter that happens to be a GYN oncology nurse practitioner. And so, her focus is a little different than mine but it's always fun when she reminds me how much smarter she is in certain areas.

Dr. Stephanie Williams: Just from my standpoint as a poor old physician here, are there differences from state to state between what you guys can do? That's one question. Two, your histories are so different in terms of how you came to become PAs, how the field of PAs and how the field of nurse practitioners developed, which is, in my opinion, very fascinating. So, I wonder if there are any comments on any of those issues?

Todd Pickard: Yes, Stephanie. That's a great question. I was just thinking about how really, when people see differences between APRNs and PAs, it's generally because of state law or an institutional policy. And that's what's very unique about advanced practice providers is that their practice can vary wildly from state to state, unlike physicians, who basically have one standard national type of practice.

An APP in Texas looks very different than an APP in New York or Alaska or Hawaii or Mississippi. And so, you do have to be very cognizant of the fact that it is important to be aware of what each state says or what even individual institutions say.

Leslie Hinds: At my institution, physician assistants are not allowed to supervise infusion, which is a big part of medical oncology. So, unfortunately, in my practice, we have nurse practitioners only and have been unable to hire PAs because of that limitation.

Dr. Stephanie Williams: So, these institutional guidelines, are they based on state regulations or just based on current practices at those institutions?

Kathleen Sacharian: Well, I think it's really dependent on the institutional experience, you know, there might be a large academic center that has a very well-developed advanced practice provider program compared to maybe a smaller community practice that has one nurse practitioner or PA.

So, I think the experience with the individual institution or clinic, but overall, that really is dictated by the state licensure and regulations. So, that is the first thing that needs to be looked at when considering these roles and responsibilities of advanced practice providers.

Todd Pickard: Stephanie, you bring up a very good point, which is whenever an institution or an individual practice takes a position, it's always good to explore the 'why'. Is this customary? Is it a habit we've been in? Or is it based simply on a misunderstanding or even a preference?

Many times, when you go to explore these things, you'll find that it's either a misunderstanding or a preference. It's not because something is required that way. At my institution, for the longest time, we only hired nurse practitioners on the inpatient side, because somebody thought that PAs didn't learn how to take care of patients in the hospital. And we had to have a conversation. I said, "No, actually, when I was in PA school, I actually had to sleep in the hospital, and for 6 weeks on my inpatient medicine rotation, so that I could give care 24 hours a day."

So, no, we are trained there. So, it was completely a misunderstanding. And so, I think that's why it's very important that you have advanced practice providers who are part of your leadership in your governance, so they can help you craft good practices, good policies, top of license practice so that you really maximize all the team members.

Marty Clarke: All these points are really poignant. The example of PAs not being able to oversee infusions, that probably stems out of an assumption that PAs, unlike oncology nurses that then become NPs, are more qualified somehow for infusion.

And it goes back, I think, to what we talked a little bit about the training, where PAs are trained in the medical model. There are assumptions that are made around that that sometimes are not correct, just as the nurses are trained under nursing theory. And there are assumptions that are made around that. In my practice, there's a belief that the nurses can't function in the hospital, which is, you know, kind of ironic to me. And I think it's an assumption based on their training and an incorrect assumption.

So, again, Todd, you're right. You need leadership and an open mind to this and also, you've got to pay close attention to what the individual, you know, state laws are, but they're more similar than they are different, I would say.

Dr. Stephanie Williams: Just as a for instance, guys, I practiced for several years in the state of Michigan, the law has changed now, thankfully, but I had a combination of nurse practitioners and physician assistants, and my nurse practitioner, by law, could not order a consult for physical therapy, only my physician assistants can.

So, I think it gets frustrating for physicians, because then how do I know what a PA can do and what an NP can do if, you know, I go to Illinois now and I practice under a different set of state laws.

When I started in my career over 30 years ago, PAs were quote, "surgical", they held retractors, they stitched people up, they did our urology consults for instance and put Foleys in. And nurse practitioners were more bedside, taking care of patients. I think some of that has changed.

But I don't know if you guys have any comments, how does a physician who's in practice in the rural community, and a more cosmopolitan community and academia, how do these things differ in your daily day-to-day routines?

Todd Pickard: This is a great transition, you know, Stephanie, that's a very salient point, is really to take a little bit of a deeper dive into thinking about how PAs and APRNs are trained. So, Marty, we'll get you to say a little more about PAs, and then Kathleen and Leslie a little bit more about the APRNs.

But generally speaking, PAs attend schools which are generally housed in medical schools. And so, we share the same faculty, we rotate with the medical students, sometimes we take the same courses as the medical students, and we're really trained in that medical model, which is basically a little bit of everything, the same thing as medical students.

And one thing that we have included in our training, which is different than nurse practitioners and APRNs, generally speaking, is we have surgical training, not to say that APRNs cannot be in the OR, they do some extra training as an RN first assist certification for that type of role. But for PAs, that's just simply built into our training.

And the reason that PAs are trained in this way is, you know, because we have our background in the military. In the military, we were part of the medical units. We were field medics. And then, after folks started coming back from their military service, they realized there really wasn't any civilian role for those highly trained folks.

So, some physicians at Duke University created the PA profession. And of course, they built it to work alongside physicians. So, they taught them the only way that they know how, which is the medical model, which is how they were trained, and it's interesting that PAs and nurse practitioners were born in the same year, 1965, but just in two different parts of the country. So, Leslie, Kathleen, tell us a little bit more about the training that you receive, and why does the population model matter?

Kathleen Sacharian: So, I'd say when you think about the nurse practitioner, you know, typically, and not always, but a lot of times, they'll have some registered nursing experience. And then, they decide to go back for an Advanced Practice degree.

They choose a specialty based on interests, so that might be Adult-Gerontology or a Pediatric focus. So, we're really focused and trained clinicals, you know, all of that training is really built around that population focus.

So, once you graduate, national certification, and licensure is then required. It really then takes on what happens next of roles and responsibilities, I think really goes into the training, the onboarding, and training of the provider, is a lot of times, you know, built into that on-the-job training.

There might be fellowships that the nurse practitioner is a part of. For example, there's a lot of new oncology fellowships that are coming out for advanced practice providers, which really gives them a good additional focused training to be able to be ready to provide that advanced practice care for oncology patients. Leslie, I don't know if you have anything to add to that.

Leslie Hinds: Yeah, I agree with the background and the education. you know, there are a lot of different specialties that you can graduate with an Advanced Practice Nursing degree, and I completely agree that most of the education for practice is learned after graduation. And then, you learn the specialty that you're interested in, or family practice, whatever you choose to do, but the education that you receive after graduation is mainly affecting your practice.

Marty Clarke: Leslie, I really agree with what you were saying about, regardless of your training model, what really happens in my experience working with PAs and NPs is that you develop a way of practicing that is consistent and congruent with how the team that you're on practices, whether it's just you and a physician, that's a team, and you develop a pattern of practice that is complementary. And I think that both PAs and NPs, at least in my experience, are able to make those adjustments on the fly, really.

Having said that, there are times that I'll have questions about a patient I'm seeing. And in my practice, I can go to a PA or to an NP, and there are times that I'll go to one of the NPs because they have a just a little different flavor, a little different take on something that I think might help me sort things out a little better. Other times, I'll choose to go to a PA because I know that their training is going to lend itself to kind of my way of thinking.

The medical model piece is to me an advantage and a disadvantage, and here's how I mean that. One of the things I tell the oncologists I work with, when they're looking for us to see a certain number of patients in a certain period of time, they're operating out of their experience. And because of their training, they can see to the bottom of the bucket faster than I can, and faster than any of my peers can be it PAs or NPs.

So, I'm constantly reminding the oncologist one of the things that we all bring to the table as APPs is a little more time with the patient. But the medical model sort of is focused on the biological, the pathological aspects of what's going on with the patient.

The personhood often becomes after that. And that's sometimes why I'll go to an NP because a lot of times that personhood is closer to the surface with them. So, my personal experience with the medical model, when I applied to get into the clinical psychology program, I was told, "We can't let you in this program because you've been taught in a medical model, you think in a medical model, and you'll never unlearn that enough to be a good psychologist."

And I had to beg and plead with them for an opportunity to prove them wrong. And fortunately, I guess I said something that allowed me to do that, but they were right, it was a very, very difficult task and challenge.

To me, the medical model is, you kind of, is a little bit like being a Marine, you sort of go for the meat pretty quickly, and there's sometimes some finesse and some touch that's lost in that. And other times, it's really great. You know, it's exactly what's needed.

Todd Pickard: Marty, you have said so many profound things in such a small amount of time that I'd like us to take a little bit of time to unpack that. And so, one of the things that you really clicked on, and Leslie and Kathleen also did this, was the concept of, we all come with our educational backgrounds with a certain foundation of knowledge, and we build upon that as advanced practice providers in our team-based care and our partnerships with our physician colleagues.

Any physician can trust that a new grad APP is going to know how to do a history, a physical, manage basic issues around a patient's symptomatology, and that they're not going to let patients get harmed. We know that much.

But the things that we have to learn are the specifics to the practice that we're in, whether it be lymphoma, leukemia, stem cell transplant, breast medical oncology, GI medical oncology, whatever it is.

And so, that's critically important that when you have an APP that comes to the table with that foundation, and then build from there, unless they've worked in that same specialty before.

One other thing that Marty said that was really important, I think, is that we all, whether we're APPs or physicians, really have to recognize that we treat whole human beings, not just the cancer cells in their body.

And so, I think that's a mindset that has changed significantly over time. I mean, I went to my medical training in 1990, and, you know, as an educator and as somebody who works with trainees now, I know that that approach is different because people think about the social networks, the support that folks have around that, their own mental health, can they comply with medication orders? Can they get to their appointments? Do they have resources? So, we're really thinking outside of that box.

And I think another thing that you said, Marty, that is so interesting to me is why do people focus on so many misconceptions in medicine? 'Well, you can't X because you're a Z.' That makes no sense to me. And for some reason, we spend a lot of time, I'll just say what I think it is, with these turf battles, 'don't play in my sandbox, go be in your sandbox'.

And so, I think that's the thing that APPs are really committed to. We want to play in all the sand boxes because our focus is on the patient, not whose turf we're on. So, Leslie, Kathleen, Marty, what do you think about that kind of team-based approach and why does that matter to advance practice? What does it mean? Because I feel like it's in all of our DNA because that's how I grew up as an APP. What are your comments on that?

Kathleen Sacharian: I completely agree with both of you. I think it's just the importance of how we work together. Our patients are at the center of all of our goals, right? Our outcomes are to improve patient care and provide them the quality of care that they deserve. And that takes a village, that takes the entire team from the oncology nurse to the PA, to the physician, to the nurse practitioner, you know, it really takes all of us to be able to provide that care that they need. And that's, you know, knowing when to say I need help, right? Who to ask that question to, using your resources.

I also think like not making any assumptions. Don't assume that because a nurse practitioner has been an oncology nurse for 20 years that she's ready to go, and to be able to provide that advanced practice care. She's going to need that support and training. So, I think just not making any assumptions and just really being open-minded and working as a team is just critically important to providing that patient care.

Leslie Hinds: Yeah, I agree with that. And I do think going more on the assumption of a nurse practitioner coming into practice: if they have oncology experience as a nurse, and they've been working as a nurse for a long time, there can be challenges with the change of the mindset between the roles between a nurse and nurse practitioner.

And I think that that is underestimated by a lot of physicians or other practices and just assuming that this nurse has a lot of experience as a nurse, so they're going to transition to this role easily. And in my experience, that is not the case, and oftentimes, the nurse practitioners that I've trained that are coming in with a lot of nursing experience are much more difficult to train to be a nurse practitioners with that mindset of an advanced practice provider.

Kathleen Sacharian: I don't want to negate that experience. I think that oncology nurse experience is invaluable for how they treat the patient, how they take care of them, how they assess the patient. And just bringing that experience to practice is incredibly invaluable. But just recognizing that difference between an advanced practice role and a registered nurse role is just important to consider.

Marty Clarke: Yeah, and I'll add to that for what it's worth, all of us work in a very demanding environment and the brain is designed to be as conservative as possible in its energy consumption. So, it takes shortcuts, cognitive shortcuts, it makes up answers to questions, sometimes whether the answers are correct or not are not important.

So, that's how assumptions I think get played out. And Leslie brought up a good sort of assumption that sometimes physicians will make about a nurse practitioner that, 'Well, they were an oncology nurse so I'm going to have them just kind of do more of that sort of thing and a little less of what I would be doing', going back to the sandbox sort of analogy.

And it's really just almost a reflex. But if we can be aware of that and train our physician partners that that may be a tendency they have to think of us in a constricted way because that's cognitively easier. It's what keeps us often from practicing to the full extent of our capability and our license.

Dr. Stephanie Williams: Todd, can I just say one thing from a physician standpoint? I mean, this is great and I agree with everything. You know, there are still physicians who think that an APP is an extension of me, and you do what I tell you to do so that you can make my life easier. That's not where the focus should be. The focus should be on that patient sitting there in front of you, and how can we make their life easier. How can we all work together in the sandbox.

Marty, our psychologist, was going through our brains and how they function. How can we work together to better the care of that patient, and the care of ourselves? We have to help prevent ourselves from burning out. How do we change that focus? There are still many physicians, unfortunately, out there who want you just to be there for them, instead of being there for the patient. How do we change that?

Todd Pickard: Stephanie, that is a profound question. I think that it is one that takes a lot of thought individually because what I think is at heart here, you know, the heart of the matter is that folks are so focused on surviving day to day. They think of the tools that they can use that make their life easier.

I think what we're all saying is that we need to flip that around and think of who are the partners on my team that help me care for the patient, and we do our work together. So, if you approach it from the mindset of 'this is all my work and what are the resources that will help me complete my work', then you don't think of partnerships in teams. You think of people who do the work the way you want the work to be done and it's all about you.

When you flip that and you really embrace the power of the team, what it is a group of folks who are all sharing the burden, and who will make sure that the patient, instead of the work, the patient is cared for, and all the services and all the things that the patient needs are done by the right people.

And so, it's not about my work. It's about our work. And so, I think there are highly-functioning teams out there and they've really embraced that concept. But Stephanie, you're absolutely right. There is a model that there is 'physician work', and everybody around the physician is there to help the physician.

But I do think that that is changing because we really are looking at how folks work in teams. So, I'd be interested to hear how, you know, Kathleen and Leslie, and Marty, think about this whole 'my work' versus 'our work' and what are they experiencing.

Kathleen Sacharian: Well, I would add to that I do agree, again with that patient-focused and patient-centered care being everybody's outcome and goal. But what does that look like in day-to-day and when talking about burnout, you know, you think if you're just being delegated all of the really difficult tasks or, you know, the things that people don't want to do, that certainly can lead to burnout.

I think we need to maximize people's interests, people's focus, and specialty. Maybe it's a procedural. You know, maybe the PA or nurse practitioner really enjoys doing procedures or doing consults.

There are so many specific examples of those roles and responsibilities of how they can, you know, take some of the burdens of day-to-day patient care and maximize them based on patient interests, specialty, and again, with that overall outcome of just improving the care and being efficient, and providing that quality of care.

But really like identifying, talking, as a team working through it, have quarterly meetings about what's working in your practice, what's not working, and how we can improve this, using your resources, too. I think there are a lot of great resources out there that can help to educate the teams about best practices in a team-based model.

Leslie Hinds: Yeah, I agree, team-based care is definitely best for the patient and whole patient care, and there are definitely still barriers out there that we deal with on a day-to-day basis that are coming in between team-based care.

And I really believe that is to the detriment of the patients. You know, I think there should be more education for physicians on how to work together as a team, instead of working together just as, 'you are my servants so you're going to do what I want you to do', and not allowing the team around them to practice to the top of their license, and ability, and interest.

Marty Clarke: Yeah, I think this real a, really important subject that needs a great deal of exploration and education across the board. My way of thinking about it is everybody has a little bit of magic and sometimes we're not able to figure out what our magic is because we're forced or pigeonholed into a certain role, but allowing every participant on the team to sort of find out what they learn, figure out, and sort out, what their magic is and to be able to bring that to the table.

You know like what Kathleen was saying, that's what keeps people engaged and what keeps them motivated. When I grew up, the term was 'scutwork' you know. I was taught 'a pound of scut for a pound of teaching', but we all have to do work we don't particularly enjoy, and that has to be rewarded by allowing us to do something we really do enjoy.

And when we do that, we bring some energy to the patient and to the team. That's when synergy starts happening. But that's not, going back to what we said earlier, that's not how the medical model, it doesn't start from that position. That's what we have to, over time needs to be I think re-engineered a little bit.

Dr. Stephanie Williams: Leslie, can you give us an idea of what your day is like?

Leslie Hinds: Sure! So, for the most part, I'm in the clinic, but we have patients who are admitted then oftentimes they do go to the hospital to see them and then run back to the clinic to see my scheduled patients for office visits.

A lot of my time is spent answering questions from the infusion nurses, from the MAs, and from patient calls coming in. We do procedures, so, bone marrow biopsies, Ommaya infusions if needed, and another good portion of my time is spent analyzing results as they come in.

The sheer volume of the inbox and the results of it coming in is quite overwhelming sometimes. But, you know, taking the time to analyze results that we're hoping not to see, like a positive scan, and then developing an evidence-based plan for what to do next to help manage these patients appropriately - that's time-consuming.

I do a lot of patient education. And also, manage a lot of emergencies that happen during the infusion. So, we basically manage the infusion center and see patients and answer questions. So, that's mostly my day.

Dr. Stephanie Williams: Thank you! Kathleen, how about you? What's your day like?

Kathleen Sacharian: Well, it depends. You know, I've been in outpatient, it looks very different from inpatient, and the outpatient experience really looks very similar to Leslie's treatment visits, seeing follow-up patients, they might be a longer-term follow-up, providing symptom management, working with our triage nurses to, you know, escalate significant problems, or treating them at home, providing that emergency and infusion-related care. But I think there's also to think about part of my role was developing a patient-specific clinic for survivorship patients.

So, my role when I was a survivorship nurse practitioner was very different. I was providing program development. I was seeing patients in survivorship in long-term follow-up providing survivorship care plans.

And I really think about that when thinking about the roles and responsibilities of an APP, just how vast that really can be. You know, there could be a genetics specialty that the APP chooses where they're providing these APP-led clinics to take care of these special populations of patients.

So, just to kind of bring another idea of what the day-to-day could look like, it could be running a survivorship clinic or genetics clinic or palliative care. You know, there are so many, so many things that the APP really can provide in that day-to-day practice. And it's really from diagnosis to survivorship to end-of-life or palliative care. So, we see the patient across that continuum.

Dr. Stephanie Williams: Thank you. And Marty, how about you?

Marty Clarke: Well, I have for the last several years been working in the office seeing patients, and what I would explain to patients is the oncologist's job really is to decide what your treatment plan is going to be. My job is to get you through that treatment plan successfully and with the greatest amount of comfort.

And so, I would see patients, you know, sort of on, sometimes weekly or every other week or every few weeks basis, assess them for where they are, whether, you know, review their labs, make sure that they're fit to continue with treatment, order and evaluate their restaging imaging studies so that we have a good sense of whether or not what we're doing is working as well as we want it to. If it's not, the patient goes back and sees the oncologist for adjustments to the treatment plan.

And that's really sort of the just what my office day was like. I did, still do bone marrow biopsies and punch biopsies pretty regularly. The last couple of months, I've been out of the office and working in the hospital sort of as the hospitalist for the group.

So, I'm doing consults in the hospital and follow-up while folks are in the hospital. At the time of discharge, I get them, if they're going to have follow- up within our group, then make sure that all that gets set up so that they're not lost in follow-up.

I just see my role as being there to help the patient negotiate this very difficult period of their life, to help the physicians that I work with, to be able to use their time most effectively. And to be able to do the things that only they can do. There are some things that I do better than them and that's what I enjoy doing.

But it always just goes back to where we started with this earlier. I show up to work every day just trying to help my patients have a little better life. I suspect I'm not unique in that regard.

Dr. Stephanie Williams: Thank you! Todd, is there anything else that you would like to add? I know you have more of an administrative lean right now.

Todd Pickard: Yeah, absolutely. When I was in full-time clinical practice, a day in my life was really focused on the patient care and how the team could get through the day because normally our schedule in a busy urology oncology practice, we'd have 70 or 80 patients per team that needed to be seen whether they needed a prostate biopsy or a cystoscopy, or they were a pre-op, or post-op, or a new patient or a consult.

And so, really, our focus was how we would get through the day, and we would all communicate with each other and support each other. But really, we were focused on each patient getting what they needed and we all were there to serve the patient.

And there was a lot of good collaboration. You know, there are times the physician would say, "Hey, I don't know how to get this thing done for this patient. How do we navigate the system?" Or times I'd say, "Hey, you know, this patient is here for surveillance and I've got some concerns about either their labs or this, and this is what I'm thinking. What do you think?"

So, it was really that collaboration. I think that's where the strength of APPs and physicians working together is. As an administrator, I spend my time thinking about how policy, and top of license practice and how we credential and make sure that people have good quality care, and I collaborate and partner with all of my other fellow physicians, administrative leaders, and administrative folks.

Thank you, Dr. Williams, Leslie, Kathleen, and Marty for sharing your insights today and giving the listeners a glimpse and a better understanding of a typical day in the life and how important it is to understand the differences between APRNs and PAs. They are all an integral part of your oncology practice.

Stay tuned for our next episode, and until next time, take care.

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TRANSCRIPT

Dr. Dave Johnson: So we're back here with another episode of our world-famous Oncology, Etc. podcast with two very distinguished guests, Pat.

Dr. Pat Loehrer: Well, we're thrilled to be here to record this episode in front of an audience. Usually it's just Dave and I, and supposed to be a live audience. Although after three-and-a-half days of ASCO, I'm not sure if anybody's still alive. We have two very distinguished guests today. Mr. Bill Brummel is the award-winning documentary producer and director. He and his films have been recognized with the Peabody Award, two International Documentary Association Awards, five national Emmy nominations, and have been named for the Oscar shortlist. Many of Dr. Brummel's films have focused on civil rights and human rights issues.

After having his voice box removed in 2016 due to complications from radiation therapy, which he received for his head and neck cancer, Bill produced and directed Can You Hear My Voice? This film, which has not yet been publicly released, was shown on Saturday afternoon here, chronicles London's Shout at Cancer Choir, whose singers are living without voice boxes. It's amazing. The ASCO Annual Meeting attendees saw this on Saturday, and today what we're going to do is hear and see some of the clips from the movie and hear from the director himself.

Dr. Dave Johnson: We're also joined by Bill's physician Dr. Uttam Sinha who encouraged Bill to create this documentary about the psychosocial aspects of living without a voice box. Dr. Sinha is an Associate Professor of Otolaryngology at the University of Southern California where he tells us he spent the bulk of his life. He's also the Watt Family Endowed Chair for Head and Neck Cancer at his institution. Dr. Sinha's holistic medical approach was really truly critical, Bill tells us, to his both physical and emotional recovery following laryngectomy. So Bill, Dr.Uttam, welcome to Oncology, Etc.

Mr. Bill Brummel: Thank you very much. But one thing your audience should know and you should know is that after having a laryngectomy, speaking with a voice prosthesis, we lose the ability to laugh out loud. So, Pat and Dave, if you happen to tell a joke or say anything funny, know that I'm laughing inside.

Dr. Pat Loehrer: I think Dave and I think that most of the people that listen to our podcasts probably have had laryngectomies because we hear no laughter at all from anything we say. So, Bill, we're really here today to talk about your documentary. And we're going to show a few clips. But before we show the first clip, can you set this up for us?

Mr. Bill Brummel: This clip sets up the choir and the premise of the film. We follow the choir as they prepare for the most ambitious concert they have ever attempted. So it's really just setting up the premise.

Dr. Pat Loehrer: Now this is extraordinary. So if you could run the first clip for us. Appreciate it.

[Clip starts playing]

Speaker 1: I'll remember quite well, when I first suggested let's form a choir. They responded with laughter and surprise and disbelief.

Speaker 2: It just seemed ridiculous that you would expect a group of people with no voice boxes to stand up and sing in a choir. It didn't seem realistic. But Thomas had confidence that we could do some things. We went along with his mad scheme. And then one day was sort of now, what about a concert? What?

[Jazz playing]

Speaker 3: Well, the people in the choir are just normal people.

Speaker 4: I really admire the courage that it's kind of taken to come through all of their treatment.

Speaker 5: After all the stuff they'd gone through, they're able to turn that into something creative and artistic. That's really, really impressive.

Speaker 2: The concept is something new. It's almost a defiance, which is what people need, is to be defiant. Was that a F sharp I sang or what was it? You know, it doesn't matter.

Speaker 6: Most of them never read poetry before. Most of them never sang before. Most of them never were on stage before. And they were going to put on a show. And they're going to add this other two or three layers of emotional vulnerability.

Speaker 1: All right. Everyone, just like we prepared. We know what we're doing and we're going to enjoy ourselves. Yeah?

Speaker 6: We're doing a concert. People have paid money to come and see us. The adrenaline rush is incredible. I can't describe it really. I never thought I would do something like this.

[Applause]

[Clip ends]

Dr. Dave Johnson: Tell us a little bit about how this film came about. Obviously, you had a personal connection to it. But give us a little bit of background information, if you will.

Mr. Bill Brummel: Well, about nine months after my laryngectomy and after getting through some of the emotional and psychological problems that a lot of people who've had the surgery experience, and we'll go into that later on, I went to an appointment with Dr. Sinha, a regular scheduled appointment. And out of the blue, he suggested that I make a documentary about the psychosocial aspects of recovering from and living with a laryngectomy. Now my first thought was stick to medicine, doc. I'm the professional here. Just kidding. It was an excellent idea. But why on Earth did you suggest that?

Dr. Uttam Sinha: We never get to see the psychosocial aspect or the challenges or the suffering they go through, and most importantly, the head and neck cancer is not so well known in the society, unfortunately. So all my life, in my 25 years of practice, I always tried to promote head and neck cancer awareness in our society. One day I told my friends, 'I need to raise money for research for head and neck cancer.' So they asked me, 'What is head and neck cancer?' I said, 'This is head, this is neck – cancer of this area is called head and neck cancer.

So anyway, so that was one of the driving forces then to create awareness within the society and also how the head and neck cancer patient live after going through the treatment and surviving the cancer.

Mr. Bill Brummel: When Dr. Sinha suggested it, it was an excellent topic. But I knew I needed a story to illustrate it. So right after the appointment, I went home, fired up Google. And very quickly, I discovered the Shout at Cancer choir on a website. Shout at Cancer is a London-based nonprofit charity, that among other things, uses some breathing techniques and singing techniques to improve the vocal outcomes for laryngectomy. Now, I knew that if I could get all the pieces in line, that this would be a great way to produce the film that I wanted to produce, that of a group of people who've undergone a life-altering surgery, and all the hardships and drama that goes with that, but still leading a meaningful and productive lives in a very entertaining fashion.

Dr. Dave Johnson: There's some really extraordinary people in this film from the Shout at Cancer choir. How did you happen to select the specific individuals within that choir group?

Mr. Bill Brummel: Well, I took two production trips to the UK after we found funding and after I got the choir on board. I took two pre-production trips to the UK and went to every choir member's home individually and met with them and their spouses. Now, they all have compelling stories. But for reasons of time, I couldn't have personal profiles on all of them. But I eventually settled on five. And I knew even then, that only four would probably be included in the film. I say that they have compelling stories. I think I could have done a Netflix limited series 10 episodes, one on each choir member.

Dr. Dave Johnson: I think you should consider doing that.

Mr. Bill Brummel: That might be too late to do that. But they're really excellent and articulate and all have slightly different stories.

Dr. Pat Loehrer: You told their stories. And again, for those who haven't listened to the documentary, I really encourage you to do this when this comes out. But just I have a question. You've done so many different documentaries about so many important things over the years. Do you think you would have done this documentary had you not had a laryngectomy?

Mr. Bill Brummel: Definitely not. A laryngectomy was not even on my radar. I don't think I knew what it was before I was faced with having it. So no, I definitely wouldn't have done that.

Dr. Pat Loehrer: It really is a terrific service that you've done. You've helped so many people. Dr. Sinha, there may be a listener or two that listens to the podcast that is not a physician. Can you explain just in lay terms what a laryngectomy is and what it means and the process behind it?

Dr. Uttam Sinha: So, as you know, that larynx is an organ that produces sound. It doesn't produce speech. This a misconception within in our society that the patient undergoing laryngectomy they cannot talk. A laryngectomy patient, they talk well, but the patient when I remove a portion of the tongue for a partial glossectomy, then they have a hard time to speak because speech is produced within the oral cavity.

So a laryngectomy is basically, the removal of the voice box removing the trachea from the esophagus so that they can breathe well and also they don't aspirate because that's a big challenge. Aspiration pneumonia, is a consequence to fibrosis induced by radiation.

So early on in our practice at Keck School of Medicine, 25 years ago, we started this program where we decided to do neuromuscular electrical stimulation swallowing therapy to reduce the fibrosis so that there'll be less chance of aspiration, and aspiration-related pneumonia. So the laryngectomy we perform, especially in Bill's case, he's a cancer survivor, but he had a hard time breathing and talking and also mild aspiration. So that's why we had to do a laryngectomy where we remove the voice box, and that improved his overall quality of life.

Mr. Bill Brummel: I remember as my breathing difficulties increased, Dr. Sinha advised me that a laryngectomy was in my future. And like I said, I didn't even know what it was. But he advised me that my quality of life would improve in the long term. But I was in denial. So I stalled. I didn't have it when he first advised that I have it.

Dr. Pat Loehrer: Here at ASCO, we have 30,000 to 40,000 people there, many of them are cancer survivors, and I'm thinking about when we think about most cancer survivors, Dave is one of them, and we'll talk about that in a little bit, most of them fit in with the crowd. The cancer survivors with laryngectomies something that doesn't. This is something that not only have you survived it, but you have the wounds to show for this. Can you tell us a little bit about that and briefly the thought processes of 'Listen, someone's going to take out my voice box. I'm a director. I need to have this.' I'm sure you stalled making this decision. And what was the final tipping point for you to have this done?

Mr. Bill Brummel: Well, as my condition got worse and worse, it was really hard to speak. And it was really hard to breathe. At times, my wife could hear my labored breathing from the other rooms of the house. I couldn't even climb maybe three or four stairs without getting winded. And then I remember the date of March 10th of 2016. I went to another appointment with Dr. Sinha. And I don't think I got two sentences out before he interrupted me and said rather firmly and with a good sense of urgency, 'Bill, we have to do the surgery now.'

He was obviously concerned that I would have a breathing emergency at home or in the market, paramedics will be called in, they do an emergency trach on me. I knew that Dr. Sinha would do a much better job than a paramedic. But I remember sitting in that exam room with Dr. Sinha and my wife, and the Dr. Sinha was basically telling me I was risking my life if I didn't have the surgery. My wife was worried sick. And although I was frustrated, I couldn't come up with any more excuses. So I said, 'Yes, let's do the surgery.'

Dr. Sinha wanted to admit me right then and there, and not send me home, but the OR was booked on the next day. So Dr. Sinha, bless his heart, called an OR to come in to do the surgery on a Saturday. I was the only one in the recovery room or the pre-op room. And I remember that when we arrived at the hospital, I think we have a clip of our kids, my wife, and I, we were sitting in the admissions waiting room. And my wife got out her cell phone and asked if she could record my natural voice, although wheezy and weak, one last time. And this is the 35 seconds.

[Recording starts playing]

Frances Fitzgerald: Okay. What's happening today?

Mr. Bill Brummel: It's 5:30 in the morning, March 12th, 2016. And today, I'm giving away my vocal cords. And walk out of here, hopefully within a few days, with voice prosthesis and a new voice. Although I won't be able to test the voice for several weeks, I'll have to be silent, which will please many people around me. So that is what is happening. Last time you'll hear this voice. So to all of you, I love you. Thank you for all your support and prayers. Here we go.

[Recording stopped]

Dr. Dave Johnson: So I'm sure that that probably brings back some very emotional memories to you, Bill, and as Pat asked, post-operatively, what did you think about your future? What was your psychological state at that time? And how did you feel physically?

Mr. Bill Brummel: Well, physical recovery from the surgery was hard. And I vacillate by saying it was hard and it's awful, but it was physical recovery. But worse yet, I was saddled with insecurity and fear and doubt. People who have had the surgery can often lose confidence. They can sometimes retreat from society and withdraw into a world where we don't have to be seen in public. But when we do that, lonesomeness and depression are sure to follow. There were times I found it easier to isolate myself rather than navigate. I didn't want to go out. I didn't want people to see me. And I got depressed. It was just natural. Losing your natural voice is really traumatic. From the time we learn to speak, much of how we perceive ourselves is wrapped up in the unique tone of our voices. It expresses laughter and happiness. And with that gone, many patients really struggle with anxiety, self-doubt, and doubting their self-identity.

Dr. Dave Johnson: So, Dr. Sinha, is that a common reaction amongst your patients post-surgery?

Dr. Uttam Sinha: Yes, it's fairly common. That's why I started 16 years ago with my colleagues a survivorship program to support the psychosocial aspect of these patients. Whenever we can, we mentor the newly diagnosed patient with the established patient. Bill has done many, many mentoring for those patients who underwent laryngectomy after his laryngectomy. And I'm so grateful that our patients are so supportive to each other for the whole organization. So yes, this is very common and that's why we always talk about not just the physical but psychosocial aspects of our health. And also in our practice, we always try to promote not only the health of the patient but also health of the caregivers and the family to improve health. I think it depends on all four dimensions of health, which is the WHO definition of health, the best state of physical, mental, spiritual wellbeing, and not a mere absence of a disease process.

Dr. Dave Johnson: You mentioned the family. We want to get back to that in a moment. I think we have a clip from Sara. She was one of the patients that was featured in his film, and there's a wonderful clip. I want to get to that in just a moment. But I just have an important question to ask Dr. Sinha. Was Bill a good patient?

Mr. Bill Brummel: Was I a good patient?

Dr. Uttam Sinha: I have to think about that.

Dr. Dave Johnson: That's what I thought. We'll watch this clip while you think about that.

[Video clip playing]

Sara Bowden-Evans: I have two vivid memories of those moments just before going down to theater and having the realization that when I came back out, I wasn't going to be the same person. I would never be me again because they would taken my personality which would mean my voice. And then when I came around, I couldn't call for help. And that was so frightening, really scary.

That was pretty awful actually coming to terms with all of this. I lost all my confidence and didn't want to speak. You can sound very angry all the time, even when you're not. I didn't want anybody else to really see me or hear me and all the other things to contend with as well, not being able to swallow properly and losing all my taste with radiotherapy, suddenly gone. I think the loss of laughter is one of the most difficult things for me. So it's just one thing after another after another and it just made me angry all the time.

Speaker 7: Emotional changes were quite dramatic. She was very, very moody at times. She just felt that everybody was staring at her. And it just changed her personality.

Speaker 8: We know from evidence that people who've had a laryngectomy can be much more likely to experience anxiety, depression, social withdrawal that can have a really important impact on relationships.

Speaker 7: The emotional side is the hardest part of caregiving. That's part of a relationship. You take the bad times with the good times.

Sara Bowden-Evans: I know that I wasn't a very good patient because I know that there were times when I was really horrible to him because I was dealing with my situation, and I took it out on him. But he's still here. He stayed with me regardless.

[Video clip stopped]

Dr. Pat Loehrer: As you watch this film, you realize what a remarkable human being Sara is. She's a writer, she's a poet, and even the title of your documentary comes from her.

Mr. Bill Brummel: I stole it from her.

Dr. Pat Loehrer: Yeah, it's extraordinary.

Mr. Bill Brummel: It's one of the poems she wrote and we use in the film.

Dr. Pat Loehrer: The question I'd asked Dr. Sinha, if you don't mind just following up on this, when a woman is diagnosed with breast cancer, as my wife was, there's this wonderful support community, and they even have a color of their own. And the women get together and they have runs and they do all the stuff. Similarly for several other cancers. I think with head and neck cancer, the inclination, I think, as Bill mentioned earlier, is to be isolated and almost withdraw yourself. This was a unique group of individuals that got together for this project. We'll hear about it more. But how common is it for laryngectomy patients to actually bind together? Or do they typically fight this battle alone?

Dr. Uttam Sinha: So they feel very isolated, no question, and depressed. That's why it's very important to have that kind of support system. Head and neck cancer is very unique. Most other cancers, squamous cell carcinoma, the same cancer when it happens in the lung, and you remove half of the lung, nobody would know and person's quality of life would not be compromised.

On the other hand, if same squamous cell carcinoma happens in the head and neck area, it compromises quality of life because all the function that makes us human beings - speech, swallowing, hearing, balance, smell, taste, all those things happen in this area. So when this area is damaged, whether by cancer itself or treatment related, that causes tremendous depression as their functional status goes down, and also they get isolated because they cannot go to the society freely, like to go to a restaurant and feeding himself with a G-tube with the rest of their friends or family are eating by their mouth. So that's quite depressing. In fact, I have patients, couple of patients who committed suicide because they were G-tube dependent. So head and neck cancer in that regard is very unique compared to other cancers.

Mr. Bill Brummel: I would say, to just add one point in regards to Sara and other women who have a laryngectomy, obviously, we don't have a lot of breakage in our voice. Our voices are very low. And it's really the same for women as it is for men. But men's typical voices are lower and women's are not. So that is a factor in their emotional recovery. They really don't sound how they used to when speaking with a voice prothesis or through an electrolarynx. So it's really difficult for women.

Dr. Pat Loehrer: As humans, we think in the past and the future, we go back and forth, but you've had a life as a very successful film producer, director. And I think in many ways, this is probably one of the most unforgiving professions for any kind of disability, whether it's even putting on some weight or having an accident. But tell me a little bit about your life before laryngectomy and after laryngectomy. How has this changed your life as a professional? What has happened?

Mr. Bill Brummel: Well before even my laryngectomy, before cancer, I was originally diagnosed in 1997 with tonsil cancer. It was treated by neck dissection, not by Dr. Sinha, and seven weeks of radiation antidotes over wide fields. I had been in television production for about 10 years prior to that. And I was doing mostly silly reality shows, or music video shows, stuff that didn't have really any substance to it. I had started my own production company about a year before, but after my cancer diagnosis, I really thought to myself that if, God forbid, the cancer comes back and my life is cut short, do I want to spend my days, my effort in terms of my work life producing shows with no substance. And I said, 'No, I don't want to do that. I want to produce shows that feed the soul as much as the wallet.' Unfortunately, 20 years after that, my soul got a lot better than my wallet. But I wouldn't change it for the world. But having cancer, having that diagnosis definitely changed the trajectory of my career. I wanted to have a legacy and something that my children would be proud of.

Dr. Pat Loehrer: Just a follow-up question, I had a very good friend of mine who had a glioblastoma. After his diagnosis, he said he learned things about friends. He said, there were three kinds of friends. There were these friends who were the loyal friends who he'd always had, who really were with him. There were the people that he had thought were friends that just disappeared. And then there was a third group of people who we never ever dreamed would be friends, but they came out of nowhere to become new friends for him. So reflect a little bit on that. Does that resonate at all with you?

Mr. Bill Brummel: It definitely resonates. After my laryngectomy, and I went through this period of emotional difficulty, I was still one of the fortunate ones. I was blessed to have a supportive network that included family and friends, others, colleagues aided my recovery. And obviously, the medical team at Keck Medicine of USC, a lot of them became my friends and are still my friends. So they came out of the woodwork. My laryngectomy buddies are close friends. We have a supportive group that meets two times a month. They become real good friends. I can't imagine my life without them. But Dr. Sinha talked about his supportive care. It was really important to me. He's always preached about a hollistic response approach to health that includes traditional medicine, exercise, nutrition, physical therapy, mindfulness, and a bunch of other things, occupational therapy, speech therapy. To varying degrees, I embraced each of those modalities. But back to your original question, certainly, some friends fell off the map. I made new ones, the family and friends that I had, the relationships became really strong and a really important and critical part of my life.

Dr. Dave Johnson: That certainly resonates with my own experience as a cancer survivor as well. And you've mentioned your family more than a few times. I'm confident that they were a very important part of that support system. Could you speak to that a bit?

Mr. Bill Brummel: Well, they understood what I was going through. And if they didn't understand, they asked questions. They didn't ignore the elephant in the room. My wife, as a caregiver, I really don't know what I would have done without her after my laryngectomy. She was changing all my dressings, cleaning out the stoma, stuff that I assume if I was alone, I could have done it, but I didn't want to. I didn't want any part of it. So she got me the physical recovery. And then she started getting me the emotional recovery.

When I was feeling sorry for myself and sitting at home, she very politely kicked me out of the house. And she said, 'If you want a cup of coffee, you get it.' I would drive down to Starbucks. It took me three months to speak because the swelling wasn't going down. But she kicked me out of the house and said 'Go to Starbucks' And I would just write on my phone my order and show it to them. And that seems like a very easy thing to do, but it was a big step for me.

But it also started me thinking, well, maybe people are going to stare. But it seems like most people are understanding. And that's been my experience. I get stared at a lot all the time. And when I speak, people turn their heads. But most people are really understanding and want to help. In fact, they might even take the extra step for me that they wouldn't for some other person.

Dr. Uttam Sinha: We established a caregiver support group, Coffee with Caregivers, and Frances is the president.

Mr. Bill Brummel: Frances, my wife, yes, she facilitates the weekly meetings.

Dr. Dave Johnson: Well, there's so many rich aspects of your film. For those who have not seen it, you really do need to see this film. But there are a couple of areas that really resonated with me and reflected my experience, one of which we have a clip from this family. But I have a daughter, who was 10 at the time that I was diagnosed with lymphoma. And my wife and I did our best to shield her from the possibility that I might not survive that. In retrospect, I'm not sure we handled it quite the right way. But you have a clip from Pug and his wife, Kat, and their daughter, Lily. And I think it so reflects my own personal experience with my daughter and her reaction to me. So maybe you might want to just comment on that before we show the clip.

Mr. Bill Brummel: In the pre-interviews I did and selected a choir member for shooting, I developed an outline of what I thought the segment with life would look like. And you know when you do documentaries, you had to be able to change it at a moment's notice. So I had three interviews with Pug and Kat and came up with a sweet story that involves just them. When we recorded the interview, I was just blown away by Pug's daughter, 12-year-old Lily, and completely changed the focus of Pug's presence in the film to illustrate the impact that a cancer diagnosis and a laryngectomy has on families.

[Video Clip Playing]

Interviewer: When your dad got the laryngectomy, how did you deal with it?

Lily: I think I was probably more upset than dad seemed because I thought he was really going to die.

Pug Halliday: It's hard because we were always honest with Lily. But no matter how many times we said it was going to be all right, you know, you were worried, weren't you?

Kat: Basically after the operation, Pug had a lot of black, like Frankenstein stitching and drains and tubes. And Lily hadn't really seen that sort of thing before. Because she was younge,. I didn't want her to be frightened, so I waited and I spoke to Pug. 'When shall I bring her up?' And he said, 'Why don't you take a photo?'

Pug Halliday: The drain's around, so that would be five, seven days after my operation.

Mr. Bill Brummel: And Lily, so that didn't scare you, the photo?

Lily: No, because he was—well, I think that yeah, it scared me a little bit, but in that photo, he's like really happy, so-

Pug Halliday: By the time when we asked Lily, she said, 'You were smiling and had both thumbs up.' So, you were reassured a bit by that, weren't you?

Lily: Yeah.

Mr. Bill Brummel: Lily, what did you do to try and make your dad feel better during his recovery?

Lily: I made tea for him.

Pug Halliday: Yeah, you came and you read me stories instead the other way around.

Lily: I read you stories, and I made him lots of things as well. Like, I don't know, like little books where he was really amazing.

To you, my favorite person in the world.

You are the best.

You're my inspiration.

I love your facial hair and your mustache presentation.

When you were ill, feeling depressed,

I knew you'd make it because you're the best.

You're kind.

You're brave.

You're funny, too.

I'm so happy I have you.

I can't believe that you're my dad.

It turns out that you're not so bad.

[Giggles]

Pug Halliday: I keep these by my bed. And when she turns into a teenager and hates me, I shall read them regularly.

[Video clip stopped]

Dr. Dave Johnson: If that poem doesn't melt your heart, you have a heart of stone.

Dr. Pat Loehrer: What you can't appreciate on a podcast this incredible poem. It's just incredible.

Mr. Bill Brummel: He's a marvelous character. You know, you're mentioning your daughter, my daughter was eight years old. And my son was five-and-a-half in terms of when I had my original cancer diagnosis. In fact, we celebrated his sixth birthday in the hospital. On the last day of my radiation treatment I had to be hospitalized three times because I couldn't keep anything down. But my daughter commented, this was when she was graduated from high school, I think, that she really thought that I was going to die. And we said no such thing. In fact, like Pug, we tried to reassure her that my tonsil cancer diagnosis was not life-threatening. But in her mind, she remembers it as being a case that my dad might die.

Dr. Dave Johnson: Yeah, my daughter reacted the same way. And she kept a diary at the time. When we went back and read her diary, she actually wrote, 'My dad is going to die.' Yeah. The other clip that really stood out to me also involved a poem, and it comes from Sara. Sara is a real star in this. It's a poem to her husband, Nigel. It's a cancer survivor's reflection on how they dealt with their cancer and their spouse during the intensity of the treatment. I wonder maybe if you could make a few comments and maybe we could show that clip.

Mr. Bill Brummel: Well, definitely. The spouse or partner, the impact can be great. And in Sara's case, in her words, she took out her frustrations on Nigel. And Nigel was a great caregiver and just dealt with it and never stopped loving her. Interesting thing about this poem, it was not a poem for the choir. It was after we finished shooting one of the rehearsals. I was talking to Sara, and she casually mentioned that, "Oh, I've written a poem to Nigel, but I'm scared to show it to him. Like he hasn't seen it or heard it." And being a film producer, I said, "Wait. Don't read it to him. Don't show it to him." We were scheduled to go out and shoot the segment with her at her home in a week or two. So I said, 'If you would read it on camera, I would love you forever.' I would have loved her forever anyway. So what you see, it's almost one take of her reading the poem to Nigel. And none of us in the room, of the crew and me, Nigel, had ever read the poem. And Nigel had never heard of the poem.

Dr. Dave Johnson: This is very real and in many ways, raw. I think it really illustrates that relationship. Again, not to talk about my own illness, but I felt the same way Sara did.

[Video clip playing]

Sara Bowden-Evans: So I need to read you something.

Nigel: You need to read me something?

Sara Bowden-Evans: Yeah.

Nigel: Go on then.

Sara Bowden-Evans: I wrote another poem that is for you.

Nigel: For me?

Sara Bowden-Evans: Yeah. I'm going to try to read it very easily now.

Nigel: When did you write this? Kept that very secret.

Sara Bowden-Evans: Because I don't know how else to say what I needed to say.

Nigel: Okay.

Sara Bowden-Evans:

I'm sorry for the pain I caused.

I'm sorry for the hurt.

You were always in the firing line

To take the brunt of course

It's not that I'm actively directing it to you.

It's just you're the one that's always there.

And that's the truth.

They say we always hurt the ones we love.

And there's a reason.

And that's because the ones you love the most know all your feelings.

You've suffered with me.

All the pain, the sadness, and my darkest days.

You forgive whatever nastiness I throw.

But I don't know how to ever repay all the things you've done,

apart from writing down in words.

Nigel: That was so beautiful. Thank you. That's amazing.

[Video clip stopped]

Dr. Dave Johnson: I know that there are no words that can describe that.

Mr. Bill Brummel: Yes. Sara really is the emotional center of the film. And from a producer's standpoint, I don't mean to sound crass, but you always can get behind a person cry on camera.

Dr. Pat Loehrer: When I was watching the movie, though today, could you get behind me because I was crying.

Mr. Bill Brummel: Well, I usually, at any public screenings, and because of COVID, there hasn't been a lot of them, but I try and view the film from the back of the audience. And I'm scouring the audience to make sure they're laughing or crying at the appropriate places. And they usually are.

Dr. Dave Johnson: So Bill, what message would you like for oncologists to take away from your documentary?

Mr. Bill Brummel: Well, very simply. It's the message I would like oncologists to hear and implement, and a lot of them do, but it's to treat the patient and not just the disease. And that's it in a really simple form. The psychosocial consequences of any cancer diagnosis are challenging, and especially as Dr. Sinha said, in head and neck patients, where the treatments often leave a patient disfigured in a noticeable and visible way. Shame, anxiety, and depression are common enemies. Support the psychosocial health of your patients. And I'm convinced that if you do that, their physical condition will improve.

Dr. Pat Loehrer: Well said. We certainly can't let you out of here without showing a clip from the choir's performance at the concert that you filmed. In fact, there were several, several songs. I think we're going to show one of them there. But can you tell us a little bit about the film distribution plans, the business of this, how will the public be able to see this film? What's happening on that end?

Mr. Bill Brummel: Well, we have a commitment from PBS if I want to show it on the PBS network of stations. We're aiming for a 2023 broadcast, probably spring. Currently, I really want to maximize the impact the film will have with the general cancer community. And for the last six months or so, we've initiated impact and outreach campaigns. And by that I mean we're doing branded screenings and webinars and speaking and showing films at conferences. We're aiming at the cancer advocacy and support communities, universities, medical schools, clinician associations. We've done a bunch so far. We're doing more. We're also trying to partner with corporations or nonprofits to bring these screenings to cancer advocacy and organizations that might not be able to afford a screening. And we're looking for underwriters with the PBS podcast. But the film will get out there. I just really, for the time being, want to concentrate on the cancer community.

Dr. Pat Loehrer: That's terrific. So we're going to show a one of the performance clips. Do you want to set that up for us, there.

Mr. Bill Brummel: COVID shut down the choir. So every time I see a performance, it makes me long for more and more performances. But this clip is as rendition of Ain't Got No, which was popularized by Nina Simone in the '60s. It was originally written for the musical 'Hair', but one of the unique things about the choir is that they at times rewrite lyrics to songs to make them more illustrative or the lyric to explain the full impact of having a laryngectomy. So this is the song we're playing last, it's the finale of the concert and the film. The first half of the song speaks to all the things we've lost by not having a voice box. Second half, which we'll see, speaks to all the things we still have, can still do in life. Sara helped adapt the words. It was a group effort.

[Video clip playing]

Singer: [singing] What have I got? Why am I alive anyway? Yeah. What have I got? Nobody, nobody can take it away. I…

Choir: [singing] got my hair, got my head, got my brains, got my ears, got my eyes, got my nose, I got my mouth. I got my smile.

Got my health, got my tongue, got my teeth to make these sounds, in my head I change my breath, I got control. I got voice. I got poems, I got friends, got my songs, got my limbs, got my heart, got my soul, got my pride.

I got my voice.

Opera Singer: [singing] What have they got? Sing, what have they got?

Choir: We've found our voice.

[Applause]

[Video clip stopped]

Mr. Bill Brummel: Obviously, the woman that sang at the end did not have a laryngectomy. She's a professional opera singer.

Dr. Dave Johnson: I think I can safely say, for all of us here today, that we thank you for producing such an inspirational film, and one that really I think captures the emotions that go along with, one, being diagnosed with cancer, two, going through treatment, three, experiencing survivorship and the support. And Dr. Sinha, to you, thank you for inspiring Bill to doing that.

We have maybe just a couple of minutes if there any questions from the audience. We haven't received any via the text. So if there's any questions, there's a microphone here. And as an added incentive, if you ask a question, you get a free Oncology etc. t-shirt.

Dr. Pat Loehrer: Better yet, we may not give them. That might be a great incentive.

Dr. Dave Johnson: Don't trample one another running to the microphone. I see, there are people who want their t-shirt. So please.

Question 1: Thank you so much. That was a beautiful film. I'm a nurse, and it's a great inspiration. And I'm sure it's a great inspiration to the patients. Are there any similar organizations in the United States doing a choir?

Mr. Bill Brummel: Not that I know of to the extent that Shout at Cancer does. There's several laryngectomy support groups or laryngectomy clubs around the United States. And every once in a while, you'll see one that the patients get together and sing for fun or they do a Christmas performance at some event. But Shout at Cancer takes it really to an unheard of level. I've never heard of anybody doing this in the world as much as they do in terms of the original writing, the professional musicianship, the rehearsal. So I'm not aware of any that take it to that extent.

Dr. Pat Loehrer: I just want to say from my own behalf, we're in this world. The best thing you can do at the end of your life is to say that you made a difference. And this film, what you have done has made a difference. As long as I have the capacity to remember, I will remember you and I will remember this film. So thank you very much.

Mr. Bill Brummel: You're welcome. And thank you for saying that. I'm touched. And that exactly was the point. I think that was the point when Dr. Sinha said, 'You should do a documentary about the psychosocial effects of having a laryngectomy recovery and living with a laryngectomy.' I don't know that he thought I'd do it to this extent, but that is the message I want to inspire people who've had a laryngectomy, and I want the world to know and to relate better to people and understand people.

Dr. Uttam Sinha: That gives me a lot of joy in what it means to recognize leaders like you and the society of head and neck cancer patients. And Bill has been a driving force for me to stay in head and neck cancer surgical oncology care.

Dr. Pat Loehrer: The world's a better place because of both of you.

Dr. Dave Johnson: Yeah, for sure.

Dr. Pat Loehrer: For those that were here in the audience and those at home, don't forget, you can claim credit for this. Provide feedback. And if you could, I really would like to have a little bit about who's the best-looking podcaster, if you could.

Dr. Dave Johnson: I think that's critically important. And I appreciate Dr. Sinha's recommendation. It's made me rethink my take two aspirin and call me in the morning recommendations. So I'll have to be more productive in the future.

But this brings us to the end of this podcast. I don't know if any of you in the audience have listened to our previous Oncology, etc. podcasts. We hope that you did. And we hope that you will. As we've said at the end of each of our podcasts, we welcome ideas. We will literally talk about almost anything oncology related or not. That's why we have the 'etc.' on and it's been a great joy for Pat and me. Both of us enjoy doing this. We've been great friends for over 40 years. And it's a wonderful way of cementing the friendship.

So thank you for all of you who are here in the audience. It'll take about an hour to file out with this large crowd so please be careful as you move to the doors. Thank you.

Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org.

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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

In part two of this two-part ASCO Education podcast episode, host Dr. Jeremy Cetnar (Oregon Health & Science University) continues the conversation with Drs. Lauren Abrey and Jason Faris, whose careers have criss-crossed academia and industry. They share words of advice for trainees today. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Jeremy Cetnar: Hello, and welcome to Part 2 of the ASCO Educational Podcast episode focused on career choices and transitions. My name is Jeremy Cetnar. I'm a Medical Oncologist and Associate Professor of medicine at Oregon Health and Science University in Portland. In Part 1, Dr. Lauren Abrey and Dr. Jason Faris about their motivations for pursuing medicine, and how they arrived at the different positions they've had. Today, we'll further explore career fulfillment, maximizing impact on patient care, and differences between working in academia and industry.

Dr. Faris, what have you learned from the different roles you have had, and what aspects of your current work do you find most rewarding?

Dr. Jason Faris: So, there's a lot to discuss here. In my academic and patient care roles, I felt extremely privileged to forge strong bonds with patients and their families, to offer support, counseling and hope in the context of making really difficult, challenging decisions... to rejoice in the individual victories, whether that was clean scans and normal tumor markers after adjuvant therapy for Stage III colon cancer, using the neoadjuvant therapy in locally advanced pancreatic cancer and watching them go to resection, helping to maintain quality of life by addressing key symptoms that a cancer patient unfortunately must endure, and providing emotional support when things do not go as hoped.

Whereas the latter times in GI cancer patients are unfortunately all too common. And the moments or clinic visits where the cancer has recurred, or the treatments aren't working really do take their emotional toll on clinicians. I'll just say I took many of those losses personally. And as a general rule in medicine, I tend to wear my heart on my sleeve, which can be a mixed blessing. But that shared sense of purpose and the many times where you were able to offer something meaningful to patients and families provided real fulfillment and joy. I think at the time of the two transitions I've had, this was fundamentally the most difficult part for me, which was relinquishing these direct patient care interactions.

So, another highly rewarding part of my role in academia was working with colleagues to open clinical trials or conduct clinical research. I had opportunities to be mentored by or collaborate with multiple people Ted Hong, Dave Ryan, Chin Wu, Jeff Clark, David Ting, and others at Mass General, as well as Lionel Lewis, Konstantin Dragnev, and Steve Leach at Dartmouth. Treating patients on clinical trials was always a stressful enterprise but highly rewarding, and I had the chance to be part of some really amazing groundbreaking trials at MGH, in some cases witnessing breathtaking responses in patients who were out of treatment options, in some cases for many months.

Another highly rewarding aspect of my role in academia or my roles in academia involved all of the many opportunities to engage in teaching and mentoring, whether that's with medical students, residents, or fellows, where the enthusiasm for helping patients and learning was always infectious. Finally, I'd be remiss not to mention the wonderful nurse practitioners that I've worked with like Patty Tammaro at Mass General, with whom I cared for many GI cancer patients for years, and Elizabeth McGrath at Dartmouth, whose wisdom and dedication to patient care was really inspiring.

On the industry side, on the NIBR side, I've had the opportunity to work on novel therapeutics that are making a bench to bedside transition from a drug candidate to a first in human Phase 1 trial, which to me is a thrilling, complex, and highly fulfilling endeavor that contributes critical knowledge to advance the field. And in the best of cases, identifies therapies that has the potential, that have the potential to alter the prognosis for thousands of future patients. As a clinician or clinical investigators, those times where your patients are responding to their treatment, whether it's on or off a clinical trial are wonderful and so incredibly rewarding. And I would argue that there's a similar phenomenon in running trials in industry, where there's nothing quite as magical as having a cadre of patients who had run out of treatment options, enrolled to a clinical trial designed based on compelling science, go on to experience sustained and significant responses.

I absolutely love the commitment to patients and to follow the science, the collaborations among our teams, and interactions with our academic colleagues which I really treasure. I'm part of a team whose responsibility is to ensure the development of a clinical protocol to safely evaluate the potential of that therapeutic, carefully monitor for adverse events, evaluate the emerging pharmacokinetic and pharmacodynamic data, and most fulfilling of all, begin to observe responses in patients whose cancers had progressed on standard of care therapies. So I think the chance to have an opportunity to explore new therapeutics that might impact the eventual treatment of thousands of people with cancer is what keeps me engaged and fulfilled. It's been a wonderful opportunity and applies the clinical skills and patient focus from my prior roles and combines this with the resources and expert teams to run and analyze clinical trials.

Dr. Jeremy Cetnar: If I can opine a little bit and ask you guys some philosophical questions. I think what I'm hearing today and what I've heard from other folks who have made that transition is that in industry versus academics, you work in a team, and you're evaluated as a team. And that's very different than in academics. You're very much rewarded for, whether it's patient volume or number of papers or leadership. That seems to me like a very big difference in terms of academic versus industry. And I'm wondering if you guys can comment on that a little bit more. Then you guys also mentioned, at least you just mentioned this, Dr. Faris, is that some will also say that when you go into industry, you're able to just impact a much bigger population of folks rather than typically in an academic setting where you are working one on one with patients. And yes, you have your IETs and whatnot, but there's just a bigger vision. Would you say that those are two accurate differences that are fairly significant, Dr. Abrey?

Dr. Lauren Abrey: Yes. You are certainly part of a team. But I think if we're honest, you're part of a team when you're in the hospital. So I ran the team of research nurses. I ran the fellowship program. I needed people to manage the patients who were in-patient and to help me look after the clinical trial conduct paperwork, etc. and so I think that does translate into the setup that you find when you move to industry. It may be a little bit that your personal success, and industry can get very sometimes focused on metrics, like what have you contributed? What has the team been successful? So you do need to think about how to set yourself up for success. If you're leading the team, how do you set the team up for success? To me, that doesn't feel terribly different than academic medicine, but I could see where it could be a change depending on what your role was in the academic world. So I think that's reasonable.

The other part of what you said, I struggle with that sometimes. I feel like we tell ourselves, that we're impacting more patients. And I think that's true. If we get a drug approved, and potentially that drug is used, not only in the US, but across western countries, in Europe, potentially in China, you get a sense of that. But it's like how do you feel that? You feel the story of an individual patient. Sensing the scale can be hard. News media know this well. They often tell the story of a particular person in the Ukraine right now to try to help us understand the scale of the war, because otherwise, it's a little impossible to digest. So for me, that doesn't always resonate. I think it resonates when I go out and talk to the different physicians practicing in different parts of the world. And I think that has been an incredibly eye-opening experience for me being in the global organization, is seeing the impact well beyond the US, because I think most companies are very indexed on the US. And we understand US practice well, but I think understanding the impact we can have across the world is also really inspiring, humbling, challenging, and something I think we all have to contend with because it's not the same everywhere. So yes, no, and in between, that's where philosophical lives, so thank you.

Dr. Jeremy Cetnar: Yeah. Well, that's a fascinating perspective, the international perspective. Very interesting. Dr. Faris, how about you?

Dr. Jason Faris: I completely agree with Lauren. I think on the team question, I definitely feel like we worked on teams in academia as well, whether we're talking about the multidisciplinary groups that are needed to take care of GI cancer patients, which always involves multiple specialties. I think at MGH, in particular, we would tend to go see the patient as a group, which is a bit unusual, to try to get everyone's schedules aligned, to be able to go into the room together. But it really presented an opportunity for the patient and the families to ask questions of us as a group and hear any disagreement that's in the room between the providers right there.

There's absolutely a ton of teamwork that goes into taking care of patients. But what you were alluding to, I think, is also right, which is your promotion, your opportunities for advancement are sometimes couched on or developed from accomplishments on the individual side. And I would say more so than is true in industry. I think that's correct as well. I mean, certainly there are multidisciplinary grants that I was a part of, of course, publications that had multiple authors to which I was a contributing author. Sometimes I was first or last author, sometimes I was in the middle, but contributing to the paper. So there was teamwork there, but no question that there's an element of individual accomplishment. How many first- and last-author publications do you have? What's the grant situation look like in terms of ability to supplement the RVUs that you need to generate your clinical…? There's no question that there's an element of that that's not a present to the same degree in an industry role.

And I just wanted to speak to the impact side, because I also agree with what Lauren said here. I think the idea and the hope is that in industry, we have an opportunity to potentially affect the lives of many, many, many patients, thousands of patients potentially, with a given cancer type if a new therapy is a homerun and takes off and is approved. That's a huge draw and I think something that motivates all of us is to be a part of something like that. But of course, not every drug, far from it, unfortunately, is going to end up as an approved drug that impacts thousands of patients.

So I think it requires some recognition of that fact and patience and continuing to work on multiple projects, and always under the prism of doing the right thing for the patients while those trials are open. And I think that's the key, as well as working on scientifically exciting projects, really proud to say in NIBR that we follow the science. If there's an indication to be explored, based on the science, it may not be the most common indication in cancer, but if the science leads us to that place, that's what we work on. I think that decision making gets tougher, obviously, as you move through the system into a later stage, more commercially informed decision.

But I think and certainly on the early phase trials side, that's something that's really exciting. I think on the academic side, taking direct care of patients, you have incredible impact on individual patients, and there's a lot of individual patients. I think you have tremendous opportunity for impact there as well, and your impact can be measured by those that you mentor and teach as well, the committees that you serve on influencing other trials that may be open at your institution. So I would in no way suggest that the impact is less in academia. I don't think that's true at all. I think it's just a different approach.

And it is true that if you're lucky enough to work on a program in industry that ends up being an approved drug, you can help thousands of future patients or your team has helped thousands of future patients. That's also true when you're on the academic setting, serving as a PI, contributing safety data and efficacy data, really giving the best information back to the sponsor that you can or maybe you're running your own investigator-initiated study that can change a standard of care down the road. So that's the homerun. That's kind of the Grand Slam of situations that might develop as a medical oncologist on either side of the divide.

Dr. Jeremy Cetnar: Thank you. I'd like to shift gears just a little bit and ask you, for people who are deciding for a transition in their career, what are some characteristics or skills or other attributes that you think would make one successful in industry? What are some things that are really, really important to be successful? And that might be different than in an academic situation or not? I'm not sure. And maybe that's another question is, you know, what are some of the things that make people successful in a career in industry? Dr. Abrey?

Dr. Lauren Abrey: So I think there are so many things that you can do in industry that depending on what your strength is, I think you have the opportunity to play to that. So again, I think if you are very entrenched in the science, and that is really what makes you want to get out of bed in the morning, being in the early research group, whether it's Novartis, Roche, other companies or small biotech, you can really dig in and spend time thinking and contributing in incredible ways. And if you're the person who is much more interested, perhaps in finding out, what's influencing the patterns of care and why people are using certain drugs or certain treatment paradigms, you could absolutely work on the absolute other end and work in medical affairs and be the person who's out there, who's the critical partner to whether folks at MGH, OHSU, major cancer centers around the world, to figure out how do we bring those two together.

And I think the group in the middle typically, like the drug development group that's getting the approval, so running the large Phase 3 studies, that requires people who are in it a little bit for the long haul. Those tend to be large studies. They run over several years, you're constantly looking at the incoming data, and yet you're blind to the results. So you have to be pretty diligent while you're in that space and willing to just buckle down and work hard. But I think there are things for everyone. And I think it's a little bit similar to what I discovered when you went into medicine. Not everybody's going to be a cardiothoracic surgeon. Only a few of us end up in this weird oncology space. But I think it does give you the chance to reinvent yourself and explore a few things.

So I wouldn't say you have to have something. I think probably what you should do is talk to a lot of people. I think people make a lot of assumptions about what a change to a career in industry is or means. And you probably don't know what you don't know. So call people like me or Jason or someone who's done it and talk to people, because I think that's probably the best way you can make an informed choice.

Dr. Jeremy Cetnar: What do you think, Dr. Faris?

Dr. Jason Faris: Can I offer some advice? So are we in this kind of advice section?

Dr. Jeremy Cetnar: Absolutely. Please do.

Dr. Jason Faris: Yeah. So I would say my advice to oncology trainees would be to keep an open mind and stay flexible. I've got a Wayne Gretzky quote that I'd like to bring into this here, which is 'You miss 100% of the shots that you never take'. And I feel like I've probably taken that flexibility to a bit of an extreme with my career path and transitions. But ultimately, it's really enabled me to experience diverse career opportunities that I might otherwise not have had the chance to really experience. I think sometimes there can be assumptions or negative stereotypes about moves from academia to industry. But my own personal experience, now twice, at NIBR has been overwhelmingly positive. I've learned a tremendous amount from both environments, which I think provides me with a different perspective on design, conduct, and analysis of clinical trials and allows me to bring a patient-centric view into clearer focus in my industry role.

I think it's also really critical to recognize that there are significant stressors and positives to each of these career paths. And they're not necessarily one way. I know multiple colleagues who have made a transition from academia to industry. Other colleagues like me who did return to clinical practice in a clinical investigator role or returning from industry to an academic lab, I've seen that happen multiple times, and multiple colleagues, of course, that have transitioned to other industry roles.

So regardless of which path someone ultimately pursues, the real critical thing to me is to remember what brought us to medical school in the first place, which is a commitment and focus to patients above all else. I believe this can be achieved in many career options, direct patient care, teaching and mentoring, clinical investigator roles in the academic setting, or in industry by collaborating with academic colleagues and patient groups, focusing on programs that have high potential to advance treatment options for diseases with high unmet medical need. I happen to think GI cancers are the poster child for that, but you know, I'm a bit biased, and designing trials that are as patient-centric as possible. So that's the kind of advice that I would offer to people is not to think of these as mutually exclusive or there's only one way forward or if I make this decision, it's irreversible. I don't think any of those things are true. And I feel like I'm living proof.

Dr. Jeremy Cetnar: Dr. Abrey, back to you. Any advice?

Dr. Lauren Abrey: I can only agree with Jason, and I know a number of people who've gone in both directions, including some who have been in pharma for quite a long time, and then make a decision to go back to patient care. Sometimes, I'm going to say, like as a final career chapter, but it has been a bit like that, including in countries where it's quite difficult to return to practice, that they need to go back and redo some training.

So I think, move forward, do things that make you want to get out of bed in the morning, and that probably will change over the course of your career. But I think don't be afraid to try something because the worst thing that could happen—that's always a good question to ask yourself, right? What is the worst thing that could happen? If it doesn't work out, you can probably make another choice.

I also think you should, you know, I already said talk to lots of people. But pay attention to that network that you have and nurture it, cultivate it, because some of those people in your network might become mentors at some point, might become advocates or sponsors at some point. And always, always, always take the opportunity to mentor somebody else, including if you're young, do some reverse mentoring. I have gotten some of my best mentoring from somebody that I agreed to mentor, but he really ended up reverse mentoring me. And he's actually now leading a very small biotech and you could argue has leapfrogged part of my career. And that's a fantastic dialogue that I get to have. So, great fun. We only go around this once. So have some fun while you're doing good things, too.

Dr. Jeremy Cetnar: Ain't that the truth? And I'll tell you, this is a small world. It does feel like the more people you talk to, all of a sudden, we all are connected. And so I just want to thank you, Dr. Abrey, Dr. Faris, for your time today, for your perspective, your interesting stories. And to all the listeners, we appreciate you tuning into this episode of the ASCO Education podcast.

Dr. Jason Faris: Thank you very much.

Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org.

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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

In part two this ASCO Education Podcast episode, hosts Dr. David Johnson and Dr. Patrick Loehrer continue their conversation with Dr. Richard Pazdur, director of the U.S. Food and Drug Administration's Oncology Center of Excellence, focusing on his leadership and vision for improving cancer care worldwide. The conversation includes reflection on drug toxicities, approval processes, and complexity of clinical trials. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Pat Loehrer: Hi. I'm Pat Loehrer, the Director of Global Oncology and Health Equity at Indiana University.

Dr. Dave Johnson: And hi. I'm Dave Johnson at UT Southwestern in Dallas, Texas.

Dr. Pat Loehrer: This is the second half of our Oncology, Etc. conversation with Dr. Rick Pazdur, who's the director of the FDA's Oncology Center of Excellence. In Part 1, we chatted with Dr. Pazdur about his upbringing and his early career. Today, we're going to focus on his leadership and vision for improving cancer care worldwide. But first, we'll discuss how cancer has impacted his life personally.

I want to flash-forward. I had the pleasure of knowing Mary. And there was no question, if you had a problem in oncology, you would go to Mary and not Rick Pazdur when you were a house staff member. But moving forward a bit, I'm not sure if all the listeners know that Mary came down with ovarian cancer. Dave himself had cancer. My wife had breast cancer. It is incredibly hard to be an oncologist I think when your spouse or someone who's close to you has cancer, and particularly, being married to a medical oncology nurse. Maybe just share a little bit about that journey of being a husband of a-

Dr. Richard Pazdur: Yeah. It is interesting because going back to the Rush story, the first patient that my wife and I had in common, and this is so ironic, was a patient with ovarian cancer. The last patient that we had in common was her, which is some ironic fate, so to speak. And the story began of her illness was right around Labor Day. We had gone to Chicago in February driving back from Chicago. I noticed that she kept on taking a whole bunch of Tums and then saying - Oh, I just got a lot of GI symptoms, and she went to see her gastroenterologist or GP and he said, 'Oh, this is just, you know, indigestion.' And two weeks after that or not even that, she was in the hospital with a massive amount of ascites, needed an intensive care unit. It was readily apparent just on getting her CA 125 what she had and she wound up one day in debulking surgery and then IP chemotherapy, etc.

I think something that I learned, and I think we knew from the very beginning that this was not going to be a curable illness, and how to deal with that on an emotional level. And I have to give my wife credit. She spared me a lot of the emotion because she was such a strong person. She made all of her own calls as far as what she wanted. She would ask me what I thought, but she would do her own research, she would go to her own doctors' appointments. She said, 'You don't really need to come with me. I'm self-sufficient.' She was very much interested in helping other cancer patients, and after she died, I think one of the most cherished conversations I had was a group of women that came to me and said how much she helped them during their support group because she was a nurse. She knew she was dying. She had emotional maturity not to fall apart but to accept the inevitable in a very strong way.

My wife was a very religious person, had gone to Catholic schools, really embraced religion during those terminal years basically. And I think that was a great sense of comfort to her. But it did teach me a lot of lessons when you take care of somebody that has cancer, and that is, what a bad job we do with drug toxicities. Drug toxicities to medical oncologists and especially the people at the FDA are numbered, Grade 3, Grade 4, Grade 1. These toxicities are tolerable, tolerable to who, so to speak. And how to manage these toxicities and how they interrupt your life is one of the lasting experience I have, which I always will remember. And that has been one of my roles recently is forming several programs that we have in the OCE to look at dosing, to look at what is this definition if the drug is tolerable or well-tolerated or if the toxicities could be managed.

I always say, yeah, every toxicity could be managed, even death. You call the undertaker to manage it. So what do you really mean by that statement. But I think the issue of toxicity is an important one. And then also going on clinical trials and having people considering what you want to go on, what risk you want to take, and what is actually in the informed consent and how meaningful that is.

Dr. Dave Johnson: Really glad you brought that up, Rick. That matches my own experience with lymphoma and going through chemotherapy. And as an oncologist, one would think I would know what the side effects are. I'd recounted them dozens and dozens of times to people over the years, but until you've actually experienced them either personally or up close as you did with Mary, it's impossible to fully understand. I'll give you one example.

Fatigue. Everybody thinks they know what fatigue is, but until you've had chemotherapy-induced fatigue, the fatigue that never abates, you just don't understand what it is. It's debilitating in ways that are unimaginable to most people. So I'm sure that experience certainly shaped your view and your role at the FDA.

Dr. Richard Pazdur: Correct.

Dr. Dave Johnson: I wonder, if you might share, you initiated a number of programs recently, including programs to try to improve coordination and co-operation amongst the pharmaceutical companies. Could you speak to some of those programs for us?

Dr. Richard Pazdur: I think one of my favorite programs is Project Orbis. Project Orbis is an idea I had when I was walking down the street. It just hit me. When I came to the FDA, one of the things I rapidly noticed is how isolated the FDA was, even from the rest from the regulatory agencies throughout the world. There was very little cross-fertilization there. So one of the very first things that I did was set up a monthly tele-conference first with the EMA, the European Medicines Agency, and then we ended on Health Canada, Australia, Japan, Singapore, you name it. And one of the things that became really apparent to me, we at the FDA got applications always first—always. That's obvious. You know why they had given it to us first? The money. That's where the finances are going to be.

So we got the application first, and it could be 2 years, 18 months, 12 months, that these other countries, Canada, Australia, Switzerland, and Brazil, Israel, would get these applications. And I said, well, this isn't right, really, because these people, they have cancer. They have every right to get these medications as soon as possible, and also we have such a large agency. We have 80 to 100 oncologists that work there, and most of these agencies have one or two oncologists. So our expertise in oncology at the FDA is so much greater than these other regulatory agencies. How can we leverage that to help these other countries?

So we started Project Orbis, and what it was is that companies come in and they submit an application and they simultaneously submit the same application to the countries that want to participate in the program. They are all preselected and have confidentiality agreements with each other. And we worked together on the applications, basically reviewing the applications. So we had many meetings, tele-conversations, telephone conversations with countries. So that expedites these drugs. This has really had a lasting impact because from a worldwide perspective, it's really promoted more rapid development of drugs and rapid approval of drugs, and that's important because that establishes sooner new standards of care that will impact future trials.

So in addition to the humanitarian issue of improving healthcare for patients in these countries, it has an impact on the global clinical trial system by having new standards approved much faster and accepted by world authorities.

Dr. Pat Loehrer: Let me just jump on that for a second, just to make a comment. Back when we were growing up, there would be like three to five drugs approved-

Dr. Richard Pazdur: Yeah.

Dr. Pat Loehrer: And today, it's like once a week, there's a new indication for oncologists.

Dr. Dave Johnson: Our listeners have another question that might be appropriate to ask at this time. What is the most common mistake that drug companies make in their applications to the FDA or in the process of trying to get their drug approved? Is there a frequent mistake that you can advise them?

Dr. Richard Pazdur: Well, they don't come and talk to us. That's number one. They want, not necessarily what the best registration pathway is, but what the quickest registration pathway is. And sometimes the quickest registration pathway, especially single arm trials, are not the best registrations pathway. So my advice is rather than playing games with the FDA, to put it in the vernacular, just do the right thing and say, what is the optimal information that patients need when I develop this drug.

We're seeing a lot of problems now with various drugs where people are developing in a refractory disease setting a drug, and they plan on getting accelerated approval on a response rate. So they push and push the dose. And with a single arm study, you can't really evaluate safety that well. Everything is attributed to the drug, and they want to get the highest response rate. And they get it, and there's a confirmatory study, and the arm of the confirmatory study, the control arm may not be as toxic as theirs, and we're seeing a wave of drugs that now have inferior survival compared to controls, which probably is predicated upon, they got the wrong dose. And I think that is one of the major programs that we have, that we need to address is dosing in oncology, this 'More is better, more is better,' and 'Let's push the dose as high as possible.'

More isn't even probably good in cytotoxic days, but certainly, not a good idea in targeted therapies and certainly not a good idea in biological therapy. So we've really got to think about dosing more, penetration of targets, what's the optimal dose rather than what's the highest dose. You know as well as I do, pharmaceutical companies want to go with the highest dose because the major hurdle is the demonstration of efficacy, even in a randomized study. So nobody wants to be blamed by saying, well, you spent $100 million on a Phase 3 study and it's negative because you used too low of a dose. But then at the end of the day, we don't have a really good tolerable dose, and it's really hard to go backwards and look at dosing after a drug was already approved because the efficacy study has already been done.

Dr. Pat Loehrer: The other aspect of drug companies is not only getting the dosage there, but also the duration. There is motivation for money, and so patients are going to and-

Dr. Richard Pazdur: Oh, count on that.

Dr. Pat Loehrer: So it begs a question, and I know the FDA can't do this, but in other countries, there is a monetary review together with the toxicity review. Can you reflect a little bit about that to the best of your ability?

Dr. Richard Pazdur: Well, even within our simpler agencies, they may communicate more than we do with CMS, but all oncology drugs that when they're approved are then paid for by CMS, okay? In these other countries, that is not so. They may get approval and then they have to go to these health assessment agencies that will decide and argue with the companies what the pricing of the drug is. I think it's a mistake, honestly, for the FDA to get into pricing. We have a hard enough time with efficacy and safety, and pricing is a very ephemeral concept because it could change on a dialing. Somebody could promise you, you should approve their drug because it's much cheaper on Monday, and on Friday, they could say, 'Oops, we made a mistake. We really think that this dose has to be X number of dollars.' And you could see competition hasn't worked well in oncology with seven PD-1 drugs approved, pricing has not really been of any movement here.

Dr. Pat Loehrer: I'm sorry. Dave may have another question, but let me ask you this. Going back to the clinical trials and what industry asked you- the complexity of clinical trials is going up logarithmically compared to the way they were in the '70s and '80s. In many of the trials where we have to get all this data in order to soothe the FDA, what are your thoughts about simplifying clinical trials?

Dr. Richard Pazdur: Oh yeah. I'm for it. I am for it. If you really look at it, these are not FDA requirements for the most part. The companies want them, all of this data because it's controlled. They don't want to be blamed at the end of the day for not capturing this data or that data. They have developed complicated bureaucracies, going back in my sociology days there, complicated bureaucracies to gather all of this data, the whole CRO industry to go out and pester you guys in practice by doing site visits. It's a complicated situation and it's really predicated a lot on the history and bureaucracies that have been built up and not money to strip away those bureaucracies for fear of failure, so to speak, of not catching something.

Dr. Dave Johnson: So Rick, we're coming to the end of our time that we've scheduled. I actually have two questions for you. We've asked all of our previous guests, the first of which would be if you could talk to your 21-year-old self today, what advice would you give yourself? After you've done that, we'd like to know what books have you been reading lately or is there some documentary that you've seen that you would recommend to us and our listeners?

Dr. Richard Pazdur: I would tell myself, when I was 21 years old, relax and be less anxious. All things pass. I think we get so anxious when we're young about relatively small things. I remember my first ASCO presentation, I was petrified. My heart was beating out of my chest. I was sweating. And like relax. It's one of a thousand presentations at ASCO. We tend to magnify things, and I think age puts things in perspective. This in the reality of the world is a small thing, and people probably won't even remember it.

Dr. Dave Johnson: Excellent advice.

Dr. Richard Pazdur: My favorite author that I'm reading now for the last couple of months is a presidential historical author, Doris Kearns Goodwin. I think many of you know, she's written many books. I love her writing style. And I like non-fiction. I like biographies and I like history books, history stories rather than mysteries or things like that, fantasy books. The two books that I really enjoyed, the first one was No Ordinary Time: Franklin and Eleanor Roosevelt: The Home Front in World War II. I don't know if anybody's read that. It's an excellent book. Most of our attention in World War II is directed toward Europe and what was going on in Europe, the battlefields, etc., which I'm not a big fan of reading about battles and stuff, but this was what was going on in The White House and the relationships of all of the people that came there. It was like a hotel almost with the personalities that were flowing through including Churchill and various princes and queens, etc.

But also the interesting relation, the fascinating relationship that Eleanor and Franklin Roosevelt had, I don't know how to describe the relationship. It truly was an unconventional relationship based on some past history that they had of affairs etc., but it was just a fascinating one.

The best book, though, again I'm reading now, is written also by Doris Kearns Goodwin, and it is Lyndon Johnson and the American Dream. Doris Kearns Johnson was his biographer and spent a great deal of time with him in The White House as well as when he left The White House. But it's an excellent book on management and reading people, success. One of the things that is most interesting about Lyndon Johnson, and especially when he was running the senate before he became president, was his ability to know what motivated people and how to use that to form a consensus. Does this person want to go on this trip. I'll give it to him and then he could help me with this. Does this person want to go to this party or get on this position in congress? So it was really a skillset that he had, which I think most leaders need to know. You have to motivate people. You can't lead by an autocratic masthead, but you've got to lead from what do people want and to make sure that they feel you have a personal relationship with them.

As I say to my staff, everything in life is personal—everything.

Dr. Dave Johnson: Well, it's been a great session, Rick. We so much appreciate your willingness to spend time with us. We wish we had twice as much time. I'm sure we could go on for hours. Thanks again, and we appreciate all you do at the FDA. You've been a fabulous leader, and we hope you continue on for many years to come.

Dr. Richard Pazdur: Thank you so much, Dave, and thank you so much, Pat.

Dr. Pat Loehrer: Great to see you.

Dr. Dave Johnson: Pat, before we leave, any idea why our patients seem to get sick on Saturday and Sunday?

Dr. Pat Loehrer: I have no clue. Do you know the answer, Dave?

Dr. Dave Johnson: Yes. They have a weekend immunity.

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In part one, of this two-part ASCO Education podcast episode, host Dr. Jeremy Cetnar (Oregon Health & Science University) interviews two very accomplished physicians and researchers, Dr. Lauren Abrey and Dr. Jason Faris. We'll hear about their motivations for pursuing medicine and how they arrived at the different positions they've held in academia and industry.

If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Jeremy Cetnar: Hello, and welcome to the ASCO Education podcast episode on career paths and oncology. My name is Jeremy Cetnar. I'm a Medical Oncologist and Associate Professor of Medicine at Oregon Health and Science University in Portland. I'm delighted to introduce today's two guests, whose careers in oncology have crisscrossed academia and industry. Dr. Lauren Abrey and Dr. Jason Faris, I'm excited to chat with you about the inspiration and motivations that drive you, people you've leaned on, how you've made your career decisions, challenges you've faced, and more.

So let's start by asking each of you, could you share a little bit about your early life and background, what attracted you to medicine, and who are some of your early mentors and role models? Let's start with you, Dr. Faris.

Dr. Jason Faris: Yeah, I'd be happy to. Thank you. So, I grew up in a small town in South Jersey in Greater Philadelphia. My mom was a registered nurse in pediatrics in the maternal infant unit for many years at Cooper Hospital. I was always interested in science and medicine and my mom's dedication to her patients. Her altruism and compassion served as a real inspiration for me, for my eventual decision to go to medical school. But I took a long time to get there. I had a bit of a circuitous route to arrive to my career in medicine though it started off conventionally enough. I was initially geared towards a premedical track in college, majoring in biology, but an exciting summer research project, working on the biochemical mechanisms underlying osmoregulation in a marine crustacean with mentoring from my first true mentor, Dr. Don Lovett, led me to apply to and attend graduate school in molecular biology at Princeton.

This was followed by a position at Merck as a molecular biologist in the genetic and cellular toxicology group. I went to veterinary school at the University of Pennsylvania where I met my future wife. And then finally, back to the original plan of attending medical school, but I have to say with a much better sense of why I wanted to attend medical school in the first place, now in my late 20s, which was a bit unconventional at the time. I really did my fair share of exploration of Allied Health careers. That's for sure. I attended Johns Hopkins for medical school, where I quickly discovered a passion for internal medicine. And that was far and away my favorite clerkship and sub-internship. That's the background to how I got to medical school.

Dr. Jeremy Cetnar: Dr. Abrey?

Dr. Lauren Abrey: Interesting. I love your story. We share... I grew up in a small town, not so far away, but I was in upstate New York. And I think there were two influences that kind of got me to my ultimate passion for brain tumors. And this sounds a little quirky to start with. But I had a pretty serious head injury as a tween. So I guess I was about 12. I had a skull fracture, epidural hematoma. And while I would never have said I woke up at that moment and thought I have to be a doctor, I think I became fascinated about things to do with the brain.

In parallel, something that I think tinged a lot of my childhood was a number of family members who had cancer. So both of my grandmothers had breast cancer, while I was well aware of the fact that they were sick and battling this. And two of my aunts also had cancer. And I would say it's an interesting split in my family. So about half of them are survivors and about half ultimately died of their disease.

So both of these things really motivated me or focused me on the need to do something important, but also to do something that really motivated me to get out of bed in the morning. I think I was much more to the point. I went straight to college, straight to medical school. I remember calling my parents and telling them I was applying to medical school and having them say, "Wait. You? Really?" So it wasn't necessarily the family expectation that I would do this, but I was very driven and motivated to make some of these choices and then discover my particular interests as I progressed through medical school. So I went to Georgetown for medical school and then have trained at a number of places in the US. I think that's a little bit how I took my first step on this career journey, let's say.

Dr. Jeremy Cetnar: So take us through what the decisions were like in your head at the end of fellowship in terms of first jobs. Dr. Faris?

Dr. Jason Faris: In terms of my choice to pursue a career in medical oncology, this goes back to medical school during an internal medicine clerkship. I had an assistant chief of service, ACS, at the time, Phil Nivatpumin. He'd go on to become a medical oncologist. He really inspired me with his optimism and bedside manner, including with multiple oncology patients on that clerkship. His enthusiasm for science and medicine, his teaching skills, and an absolutely legendary fund of knowledge. For Phil, he was just an incredible ambassador for both internal medicine and for oncology.

After medical school, I went to internship and residency at Mass General Hospital. And in one of my first rotations, I was on the oncology service, which was not so creatively called Team Three. I think they can up the ante there, but oncology services on Team Three. I was caring for many extremely ill patients battling disease progression from their metastatic cancers, or sadly, in many cases complications of their treatments. During that rotation, I was intrigued by clinical trials offering novel treatment options based on cutting edge science, but also struck by the number of patients who just didn't have any clinical trial options. I became aware of the limitations of the conventional treatments that were offered.

I was really inspired by the patience and dedication of the nurses and doctors caring for them. And I vividly recall a roughly 50-year-old woman I helped care for with AML, watching as the 7+3 chemotherapy caused lots of side effects for her and being amazed by her strength and grace, her resilience as she faced her illness, her potential mortality, and the intense chemotherapy she was undergoing. And I knew during those moments with that leukemia patient while caring for other patients on that oncology service that this was the field I would pursue. Oncology was really the perfect blend of humanism, problem solving, longitudinal follow-up and rapidly accelerating scientific progress leading to new avenues for clinical trial treatments.

Like Lauren, I was motivated and inspired by cancer diagnoses in my own family. My maternal grandmother died of pancreatic cancer during my junior year of college. My dad was diagnosed with colon cancer during my first year of fellowship. So those are all really strong motivators, I would say. And after completing my fellowship at the combined Dana-Farber MGH program, my first position out of fellowship was in the gastrointestinal cancer group at MGH. I actually had been training in genitourinary oncology after my main clinically focused year of fellowship, but I did a chief resident year in the middle of fellowship, and that was the tradition at MGH. And as I was about to return to fellowship for my senior year of fellowship, the head of the GI Group and head of the Cancer Center at the time, Dave Ryan, offered to serve as a clinical research mentor for me in GI cancers. As a senior fellow, I wrote an investigator-initiated trial of cabozantinib for patients with neuroendocrine tumors under his mentorship that went on to demonstrate encouraging results, led to a Phase III study in that cancer population, and I ultimately accepted a position at the MGH Cancer Center in the GI cancer group about 11 years ago. And that was the start of my post-training career.

Dr. Jeremy Cetnar: And how about you, Dr. Abrey?

Dr. Lauren Abrey: So for people who don't know, I'm actually a neurologist. I finished my training in neurology and then pursued a fellowship in neuro oncology. I would say it was really patients and observations of things that were happening with patients during my residency. I did my residency at the University of Southern California at Los Angeles. I was at the LA County Hospital, which for people who don't know, is one of the largest hospitals in the country. I had the chance to see several patients who had paraneoplastic syndromes, and got the support from different faculty members to write those cases up, and really resulting in my first independent publications. That was what kind of got me bitten by the bug to understand this link between neurology and oncology.

I very intentionally went to Memorial Sloan Kettering to have the opportunity to work with Jerry Posner. And I think I no sooner got there than I got totally bitten by the brain tumor bug, which seems a little counterintuitive. But the paraneoplastic work was kind of deep laboratory work. And I realized that I really enjoyed seeing the patients having the partnership with neurosurgeons and digging into what is still a pretty intense unmet medical need.

So it was an interesting pivot because I really thought I was going to Sloane to focus on paraneoplasia. I still think I learned so much with that interest that I think we can reflect on when we consider how immunology has finally entered into the treatment landscape today for different tumor types and understanding is there a background in paraneoplastic disorders that could help us. But I have to say it was really the brain tumor work that got me focused and the chance to work with people like Lisa DeAngelis, Phil Gutin, and others that was kind of fundamental to my choices. I stayed there for two years of fellowship and then continued as faculty for about another 15 years at Sloan Kettering. So that's really the start of my academic career and the pivot to industry came much later.

Dr. Jeremy Cetnar: So both of you have impressive career CVs, have been trained at very prestigious institutions. So at some point in time, take me through, what was that transition like between, 'Hmm, what I'm doing is enjoyable, but maybe there's something else out there that I want to explore.' And what I mean by that is mostly industry at this point. So that's an important question that I think a lot of junior faculty face, a lot of mid-career faculty, maybe even later-stage faculty. But I think that's a tension point for a lot of people because I think there's a lot of fear. I think there's a lot of anxiety about moving outside of the academic realm. So, tell us a little bit about what was the pull in terms of going to industry and what were some of the thought processes that were going on. Dr. Faris?

Dr. Jason Faris: I've experienced two transitions, actually, between academia and industry. I like to do things in pairs, I guess. But the first was, after multiple years at the MGH as a resident fellow and as a clinical investigator at the MGH Cancer Center. As a new attending and clinical investigator, I was attempting to balance my work priorities, providing patients with GI cancers, which is a rewarding but complex and I'd say emotionally intense experience, given the phenomenally aggressive and devastating cancers these patients grapple with such as pancreatic cancer, alongside the other responsibilities of my clinical investigator position.

Those other responsibilities included writing grants and papers and protocols, evaluating patients who were interested in open clinical trials, and serving as the principal investigator for multiple studies. I was serving on committees, mentoring and teaching. Patient care was always my top priority as it should and really must be. And I feel incredibly lucky to have had truly amazing colleagues at MGH across several disciplines, from medical oncology, nurse practitioners, practice nurses, radiation oncologists, and surgeons. It was and continues to be a dynamic place full of extremely talented and dedicated clinicians. I think we really all benefited from the coordinated teamwork in both patient care and research in a really tight-knit GI Group.

But nonetheless, for me as someone who delighted in spending large amounts of time with my patients in the clinic rooms, and I think my colleagues would agree frequently agonizing over decisions impacting their care, achieving sufficient balance to really focus on writing and overseeing clinical trials was becoming increasingly challenging for me. And it was in that context, after spending roughly a decade and the combination of residency fellowship training and as an attending in the GI cancer group all at MGH that I made a truly difficult decision to move from my beloved outpatient clinical and clinical investigator role to industry to focus more exclusively on clinical research.

And after interviewing for several industry-based roles, I accepted a position in the early-phase group at the Novartis Institutes for Biomedical Research or NIBR as we kind of pronounced those words in Cambridge. I absolutely loved my time at NIBR. It's an incredible place with a strong history of and commitment to innovation as well as passionate, talented colleagues, many of whom I've worked with in the past. When I first started at Novartis, I was amazed at the array of experts on the teams I was helping to lead as a clinical program leader. Our teams are the definition of multidisciplinary. They're composed of what we call line function experts in multiple disciplines. This includes preclinical safety experts who design and analyze data from studies that precede the filing of an IND, research scientists, chemists, preclinical, and clinical pharmacologists, statisticians, program managers, drug and regulatory affair colleagues, who focus on the interactions with health authorities, including the FDA, operational colleagues called clinical trial leaders, and many others.

In my role as a senior clinical program leader, I also have the opportunity to collaborate frequently with research colleagues on preclinical programs, designing and writing first in human trials, followed by conducting the actual studies and in close collaboration with our academic colleagues, analyzing the clinical and translational results.

Dr. Jeremy Cetnar: Dr. Abrey, how about you? Was there a moment or what were the moments that led to you deciding to make this transition?

Dr. Lauren Abrey: I guess I have the other sort of story. I got pushed, I would say, in the sense that like many of us, I'm married, and my husband was the one who took a job with Novartis and said, "This would be an adventure. Let's go live in Switzerland." So similar to Jason, he took a position at NIBR, and I think for many of the same reasons, he really wanted to delve deeply into early mechanism of action and allow himself to dedicate really a chunk of his career to developing key drugs. But moving to Switzerland changes your options suddenly. I think I had spent most of my career at Sloan Kettering doing clinical trials. That was really my comfort zone, my sweet spot. And when we moved over here, I explored briefly, could I set up an academic career here?

And very kindly, I was invited by a number of Swiss colleagues to look for opportunities to do that. But I realized what I loved was talking to patients, and that that was going to be difficult with the language barrier. And I equally loved running clinical trials. So I had a great opportunity to join Roche shortly after their merge or full acquisition of Genentech. This allowed me to continue the work I had been doing on Avastin for brain tumors.

But I think the other thing that allowed me to do, that was something I was really looking for was to broaden my scope and to no longer be niched as just a brain tumor expert. And if you're in academia and you're a neurologist, obviously, you're going to be fairly constrained in that space. But moving into a role in industry really allows you to look much more broadly and work across multiple tumor types. And I spent the next seven years at Roche running not just the Avastin teams that were developing drugs for a number of indications, but really overseeing the clinical development group based in the European sites. And they had about 14 different drugs in different stages of development as well as partnerships with their early research group that was European based.

So it was a fascinating time for me, and I feel kind of like I got thrown into the pond. I knew a lot about clinical trials. I had no idea about so many other aspects of what I needed to consider. And I think Jason started to allude to some of this with the different line function expertise and things I think we take for granted or maybe we simply have blind spots around them when we are sitting in our academic organizations. So it's been a really delightful plunge into the pool. I've continued to swim mostly. Occasionally, a little bit of drowning, but a lot of fun.

Dr. Jeremy Cetnar: What would you say are the major differences between an academic career and industry?

Dr. Lauren Abrey: I think, as you said, the things that are similar is that the purpose or the mission for both is in many ways the same. We would like to develop better treatments for patients with cancer. And so there's a huge focus on clinical trials. There needs to be a huge focus on patients, and that can get diluted in industry. I think the things that you don't appreciate sometimes when you're sitting on the academic side is just really the overarching business structure and the complexity of some of the very large organizations. So you suddenly are in this huge space with people focused on regulatory approvals focused on pricing, focused on manufacturing, focused on the clinical trial execution, and why you are doing it in different spots.

And so I think some of the different factors that you have to consider are things that again, we either take for granted or are super focused when you're in one organization. And I think the tradeoffs and how decisions are made, particularly in large pharma, can be frustrating. I think we are all used to applying for grants or getting the funding we need to do whatever our project or trial is. And then you just start very laser focused on getting to the end. If you're in a large organization and they have a portfolio where they're developing 14, 15, 20 different things, you might suddenly find that the project you think is most important gets de-prioritized against something that the company thinks is more critical to move forward. And that could be because there's better data, but it could also be because there's increasing competition in the space or there's a different pull for a large company. I haven't seen the early development side as much. I've seen the development. I've now seen Medical Affairs for how some of those decisions are made, but I'd be curious to hear what Jason has seen in some of his experiences as well.

Dr. Jason Faris: Comparing and contrasting a little bit between the two, because I've run early phase studies on the academic side, I'll talk more about that in a little bit in terms of another academic position that I held. So I've run early-phase studies there. I've run early-phase studies in industry as well. And they share a lot of similarities, certainly following compelling science, the excitement about new therapies that are going to be offered to patients. But I think the execution is a bit different, and I would say, when you're running clinical trials in the academic setting, you're meeting every patient that you're going to put on study or at least one of your colleagues is, if you have sub-eyes on the study, that's a major, major difference, right? You're directly taking care of a patient going on to an experimental therapy, consenting that patient, following them over time, getting the firsthand experience and data from that patient interaction, but not necessarily, unless you're running an investigator-initiated study, not necessarily having access to the data across the whole study.

You're hearing about the data across the whole study at certain time points on investigator calls, PI meetings, dose escalation meetings, those kinds of things. But you're not necessarily having access to the real-time emergence of data across the whole study from other people's patients. So you're a bit dependent on the sponsor to provide those glimpses of the data, synthesize that and present overview. So those are some operational differences, I would say, because you're not taking direct care of the patients and having your time split among different commitments in that way I have felt a greater ability to focus on the clinical research that I'm doing in my industry-based role, which I like, of course, but I also miss taking care of patients. I love taking care of patients.

So I think it's always a double-edged sword with that if we can use a sword analogy here. But I think they both offer really exciting options to pursue new therapies for patients, which for me, was one of the fundamental reasons that I pursued medical oncology in the first place. It was really this idea that the field is rapidly advancing. I wanted to be a part of that. I saw firsthand what cancer could do to my family or family members, and I took care of patients in the hospital as an intern resident and fellow where I think there's just a tremendous unmet medical need. And so having an opportunity to contribute to the development of new therapies was always a real inspiration for me.

Dr. Jeremy Cetnar: With that being said, what led you to go back into academia?

Dr. Jason Faris: This is an ongoing saga, I guess. So after several years of professional growth at Novartis, gaining experience with designing and conducting clinical trials on the industry side, I was actually at ASCO and I learned of an open role for the director of the early phase trials program at Dartmouth's Cancer Center. After extensive consideration, which I think you can see as my trademark at this point, I made another difficult decision to interview for the position, which was focused on helping to grow the early phase trials program at an NCI comprehensive designated cancer center that's unique in a way because it's in a rural area. And it had a new director of the Cancer Center, Steve Leach, who's a renowned laboratory scientist with a focus on pancreatic cancer and a surgeon by training.

I ultimately decided to accept the early phase director position, moving my family away from Greater Boston, where we had lived for about 15 years, to the upper valley of New Hampshire. And while at Dartmouth, I was part of exciting projects, including writing and overseeing an NCI grant called Catch Up, which was geared towards improving access to early phase clinical trials for rural patients. I opened numerous sponsor-initiated immunotherapy and targeted therapy, early phase trials. Just to say a little bit about Dartmouth's Cancer Center - I think they also benefit from tremendous collaboration, this time across Dartmouth College, the Geisel School of Medicine, the School of Public Health. I think they provide really excellent care to their cancer patients. And I was extremely proud to be part of that culture in the GI Group, which was much smaller than the one at MGH, but also an incredibly dedicated group of multidisciplinary colleagues who work tirelessly to care for their patients.

But nonetheless, less than six months into that new position, the COVID pandemic started, and that introduced some significant and new challenges on the clinical trials side in terms of staffing, infrastructure, those kinds of things. In that context, I made a decision to return to NIBR, refocus on clinical research, and hope to harness my background in running clinical trials in both settings, both academic and industry, as well as the resources and pipeline of Novartis to really maximize my impact on drug development. So for me, it was a question of where can I have the maximum impact at this crazy time, difficult time. I saw that my best option was to return to industry to work on studies to try to develop new therapies. Broadly speaking, my role as a senior clinical program leader in the translational and clinical oncology group at NIBR is to design, write, conduct, and analyze innovative clinical trials of early phase therapeutics.

Dr. Jeremy Cetnar: Wow, that's fascinating, very, very interesting. A lot of stress. You should definitely be buying lots of presents for your family for moving them all over the place.

This concludes part one of our interview with Drs. Abrey and Faris. Thank you so much for sharing your inspiring career stories. And thank you to all our listeners for tuning into this episode of the ASCO Education Cancer Topics podcast.

Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org.

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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Partners in cancer care – who are advanced practice providers? In the first episode of ASCO Education's podcast series on Advanced Practice Providers (APPs), co-hosts Todd Pickard (MD Anderson Cancer Center) and Dr. Stephanie Williams (Northwestern University Feinberg School of Medicine), along with guest speaker, Wendy Vogel (Harborside/APSHO), discuss who advanced practice providers are, share an overview of what they do, and why they are important to oncology care teams. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected]

TRANSCRIPT

Todd Pickard: Hello everyone, and welcome to the ASCO Education Podcast, episode number one of the 'Advanced Practice Providers' series, 'APPs 101: What and Who Are Advanced Practice Providers?'

I'd like to introduce my co-host for this series, Dr. Stephanie Williams. My name is Todd Pickard. I'm an advanced practice provider, I'm a PA, and I work at MD Anderson Cancer Center in Houston, Texas. I'm also the Executive Director of Advanced Practice and my clinical practice is in urology. Dr. Williams, how about you introduce yourself?

Dr. Stephanie Williams: Thanks, Todd, and thanks for this opportunity to present this incredibly important topic. I am currently retired from clinical practice. I had been in practice for over 35 years both in an academic setting, a private practice, and more recently in a large institutional, multi-specialty institutional type of practice. My primary clinical care has been in stem cell transplants and cellular therapy. And we have used APPs, both PAs and NPs for a couple of decades in our particular area.

Todd Pickard: Great, thanks for that. I'd also like to introduce you to our guest panelist today, Wendy Vogel from Harborside, who is a certified oncology nurse practitioner with over 20 years of clinical experience and expertise.

We're excited to be chatting with Wendy today about the basics of advanced practice providers and who they are. This will be an introduction for the rest of the upcoming episodes of APP Podcasts. Wendy, why don't you tell us a little bit about yourself and your practice.

Wendy Vogel: Thanks, Todd. It is a pleasure to be here. I appreciate you asking me to talk. I am an oncology nurse practitioner as you said. I do a high-risk cancer clinic and do that a couple of days a month. And I am also the executive director of APSHO, the Advanced Practitioner Society for Hematology and Oncology.

Todd Pickard: Great! We're looking forward to a robust and informative discussion today between the three of us. So, I'd like to get started with some basics. Wendy, do you want to always start with a definition of advanced practice registered nurse?

Wendy Vogel: Okay, great question! So, APRNs or advanced practice registered nurse include nurse practitioners. It can include clinical nurse specialists, nurse anesthetists, and nurse midwives.

And generally, APRNs hold at least a master's degree in addition to some initial nursing education as a registered nurse. Some APRNs have doctorates like the DNP or Doctorate of Nursing Practice. But licensure for APRNs generally falls under the State Board of Nursing.

So, we're also required to have a board certification, usually as some sort of generalist as in family medicine, pediatrics, geriatrics, women or acute care. But in oncology, many APRNs also carry oncology certification.

Todd Pickard: Excellent! Thanks for that. I'll go ahead and add to the conversation by defining physician assistant. So, physician assistants are individuals who are trained in the medical model and are licensed to practice medicine in team-based settings with physicians.

Very much like advanced practice registered nurses, we come from a variety of backgrounds, and our education model is really focused on thinking about the patient the same way that our physician colleagues do.

We're trained in really taking a very broad look at patient care, and our education as a generalist model. PAs are certified by the National Commission on Certification of Physician Assistants, which is one national certification that includes all of the content areas in which we will practice.

Dr. Stephanie Williams: For those out there who don't know, what are the differences between a physician assistant and an APRN? Or are there differences in practical terms, in terms of how we practice our field?

Wendy Vogel: That is a great question, Stephanie, thanks for asking that. We function very much the same. The main difference is just in our educational background, where nurse practitioners come from a nursing background and the nursing model of care, and I'll let Todd speak to where PAs come from, but basically, our functions are very much the same.

Todd Pickard: I very much agree. If you are in a clinical setting, and for some reason, Wendy or myself failed to identify who we are, you wouldn't really detect a distinction between the care either of us provide, because we are there in that provider setting and we're really there to assess the conditions you have like appropriate history in physical examination, think through differential diagnosis or a workup, create a diagnosis and then a therapeutic plan and also to educate you as the patient or to make an appropriate referral.

So, really, when APPs, PAs, and NPs work side by side, there's really not a lot of difference in what people detect in what we're doing and how we're doing things. But there are some educational differences, which are pretty minimal.

So, for example, one small difference is that PAs include surgical assisting as part of our core fundamental training, and our APRN colleagues generally don't. So, in my institution, we do have nurse practitioners that go to the OR and do assisting, but in order to get there, they did a Registered Nursing First Assist Program, it's a certification. So, they learn those fundamentals of sterile technique and surgical technique. So, in essence, there's really not a whole lot of difference.

Dr. Stephanie Williams: I think what I was struck with about the difference was the history and the fact that PAs came out of the Mobile Army Surgical Hospitals. To me, that was just fascinating. I think Duke was the first graduating class.

Wendy Vogel: You know, the role of the APRN has really changed drastically. It began in the 1960s, because there were not enough primary care providers, particularly for children in the urban and rural areas of the US, and the first nurse practitioner program was in 1965, at the University of Colorado. So, gosh! Have we come a long way since then, both the PA role or the NP role. When was the first PA role, Todd, when was that?

Todd Pickard: We were born at the same time in 1965, we just happened to be at Duke University and y'all were in Colorado. You know, I think that the most important thing about working with advanced practice providers is that you look to work with somebody who has the competencies, the skills, interpersonal communication, and the pertinent experiences because honestly, I know fantastic APRNs, I know fantastic PAs, and I know some of either profession that really just don't quite fit a particular role.

And so, there is some kind of mythology around PAs and APRNs, and who should work where, like PAs should be more procedural and more in surgery, and nurse practitioners should be more in medicine in the hospital. And really, there's nothing in our training that defines that per se, I think it's just a natural progression of we're over 50 now, so our professions are middle-aged. And we're starting to really have our feet underneath us. And I think people who've worked with PAs or NPs really understand, it's about the individuals and what they bring to the table.

It's not really about the initials behind our names, because honestly, that's not what makes me do good work. It's not that I have the PA or NP behind my name. It's my commitment and dedication to my patients and supporting the rest of my team.

Wendy Vogel: I think Stephanie, that's why we use the term advanced practitioner, advanced practitioner provider because it doesn't single out either one of us because we are functioning in the same manner. It's easier to say than say, PAs and NPs, so we just say, APPs.

Todd Pickard: Yeah. And it doesn't mean that we don't identify as individual professions, because we do. I mean, I'm a PA, but I am part of a larger group. And part of that larger group is identifying as advanced practice provider because, at my institution, there are over 1000 of us, and we are a community of providers, and that's the way that we sense how we function within the team and within the institution. And so, it's really about that kind of joint interprofessional work.

And speaking of work, Wendy, tell us a little bit about what are typical things that advanced practice providers do?

Wendy Vogel: It might be easier to say what we don't do. I've got a list. Do you want to hear my list?

Todd Pickard: Yeah, lay it on us.

Wendy Vogel: Okay, here you go. Staff and peer education, survivorship care, palliative care, hospice care, pain management, acute care clinics, case management, research, cancer patient navigator, genetic services, lung nodule clinics, quality improvement. We're writers, we're authors, we're speakers, we mentor, and we do all kinds of public education.

We can have clinical roles with faculty and professional organizations. We do procedures like bone marrows, paracentesis and suturing, and all that kind of stuff. We do a lot with all the other things like diagnosing, all the things you said earlier, diagnosing, ordering lab tests, ordering chemotherapy, etc.

Todd Pickard: I think what's amazing about advanced practice providers is the flexibility we have to fill in gaps on teams or in service lines, no matter what that is. You know, I like to say and I'm sure everybody thinks that they originated this, but I feel that advanced practice providers are the stem cells of the team because we differentiate into whatever is necessary.

At my institution, we recently had a gap in how our peer-to-peers were handled. Many times, you order an MRI or a PET scan, and the payer will, the day of or the day before, say, 'Oh, I need to talk to somebody.' How that gets to the clinical team and when the clinical team has time to do that, it's really hard to coordinate.

So, we created a team of advanced practice providers who spend one day a week doing the regular clinical roles, but then the rest of the time, they are dedicated to facilitating these peer-to-peer conversations. They have over a 95% success rate. And the payers, the medical directors, have actually gotten to know them. And so, they'll say, 'Hey, I want to talk to so and so because she's fantastic and knows our program, and it's really easy to have these conversations.'

And so, patients are taken care of and these business needs are taken care of, and then our clinical teams can really focus on what they're there for, which is to see those patients in and out every day.

So, that's the power of advanced practice, its flexibility, filling in gaps; we can bend and morph to whatever we need to do because one of the things that's in our DNA is part of PA and advanced practice RN, we're here to serve, we're problem solvers or doers, too. When we see something, we pick it up and take care of it. That's just in our nature.

Stephanie, tell us a little bit about your experience working with an advanced practice provider, is what Wendy and I are saying ringing true, or what's your experience?

Dr. Stephanie Williams: Oh, absolutely! As I look back on my career, I'm not certain that I could have accomplished much of what I did, without my team members and advanced practice providers, both PAs and NPs.

We also use them in an inpatient setting. And I can't remember Wendy mentioned that to take care of our stem cell transplant patients, because of residency, our requirements were removed from our services, and they became the go-to's to taking care of the patients.

It actually improved the continuity of care that the patients received because they would see the same person throughout their 4 to 6-week course in the hospital, they also helped run our graft versus host clinics.

I hate that term physician extender because they're really part of our health care team. We are all healthcare professionals working together, as Todd beautifully mentioned, for a common goal to help that patient who's right there in front of us. And not only that, from a kind of selfish viewpoint, they help with a lot of the work, doing the notes, so that we could all split up the work and all get out on time and all have at least some work-life balance.

And I think that's a very important part of any team is that we can each find our own work-life balance within the team. So, I feel that they're a very important part of the oncology healthcare team. And I would recommend that everyone who wants to take care of patients, incorporate them into their team.

Wendy Vogel: Can I say something right here that you mentioned that I'm so glad you did, which was physician extender. That is a dirty, dirty word in the AP world now because we don't know what part we're extending, that is not what we do.

And also, we don't want to be called mid-level providers because – you can't see but I'm pointing from my chest to my belly - I don't treat just the mid-level, nor do I treat in mid-level care. I give superior care. I just give different care. And I give care on a team.

And the last one is a non-physician provider. That is also a no-no because I wouldn't describe a teacher as a non-fireman, nor would I describe you, Stephanie, as a non-nurse practitioner. So, I don't want to be a non-physician provider either.

Todd Pickard: It is an interesting phenomenon that even after 50 years, so many different places, whether it's the Joint Commission, or the Centers for Medicaid and Medicare Services, whether it's a state legislator, an individual state, an individual institution like Memorial Sloan Kettering or an MD Anderson or a Moffitt, everybody comes up with these different terms. And it's so interesting to me.

Physicians are either physicians, doctor, sometimes they're called providers. But as a PA, who's an advanced practice provider, those are the two things that resonate with me: either call me PA or call me advanced practice provider.

All these other names seem to just be, it's an alphabet soup, and it really doesn't carry any meaning because some places just come up with these strange terms. And I agree, physician extenders has been the one that always has amused me the most because it reminds me of hamburger helper.

Am I some noodles that you add to the main meal so that you can extend that meal out and serve more people? I think what Wendy and I are really trying to get at, I know this has been with a little bit tongue in cheek, but we are part of the team. We work with physicians in a collaborative team-based setting, just like we all work with social workers and schedulers and business people and pharmacists and physical therapists.

I think the main message here is that oncology care and taking care of patients with cancer is a team effort because it is a ginormous lift. It's a ginormous responsibility and our patients deserve a full team that works collaboratively and works well and has them in our focus like a laser, and I know that's what APPs do.

Dr. Stephanie Williams: I think that's well said, Todd. What I enjoyed in the clinic in particular, was sitting down and discussing patient issues and problems with my APPs. And we worked together to try to figure out how to resolve issues that would come up. But we also learned from each other, you're never too old to learn something from people. I just felt the interaction, the interpersonal interaction was also very satisfying as well.

Wendy Vogel: I think that the job satisfaction that comes from being a team player and working together is so much higher and that we're going to experience so much less burnout when we're working together each to the fullest scope of our practice.

Todd Pickard: So, Wendy, one of the things that people ask a lot about when they work with advanced practice providers is, 'Well, gosh! How do I know that they have this training or this experience or this competency?' And then the question arises about certification.

So, let's talk a little bit about certification and what that means and what it doesn't mean. So, tell me, are advanced practice providers certified? And are they required to get a variety of certifications throughout their career? Let's talk a little bit about that. Why don't you open up the dialog.

Wendy Vogel: Okay, happy to! So, to be able to practice in the United States, I have to have a board certification. And it can vary from state to state, but generally, it has to be either a family nurse practitioner certification, acute care nurse practitioner, geriatrics, women's health, pediatrics, there are about five. So, you are generally certified as one of those.

There are a few oncology certifications across the US, board certifications to be able to practice at the state level, but not all states recognize those. So, most of us are educated in a more generalist area, have that certification as a generalist, and then can go on to get an additional certification.

So, many nurse practitioners in oncology will also get an advanced oncology nurse practitioner certification. So, that's a little bit different. It's not required to practice. But it does give people a sense that, 'Hey, she really knows what she's doing in oncology.'

Todd Pickard: The PA profession has one national certification, and it is a generalist certification. It's probably similar to USMLE, where you really are thinking about medicine in its entirety. So, whether that be cardiology, orthopedics, family medicine, internal medicine, geriatric, psychiatry, or ophthalmology. I mean it's everything – and oncology is included as well. And that certification really is the entree into getting licensure within the states.

It's basically that last examination that you take before you can get that license just to make sure that you have the basic knowledge and fundamentals to practice. And so, I always respond to this kind of question about certification, I say, 'Well, is it really the experience and the onboarding and the training that one gets on the job and the mentoring and the coaching that one gets from our physician colleagues and other advanced practice providers that brings them the most value? Or is it going through an examination, where basically you're responding to a certain amount of information, and you either pass it or you don't, and you can get a certification?

I'm not saying there's not value in that, but I'm also making the argument that if you are working with your APPs well, and they have good mentors, and they have good resources, they're going to be excellent clinicians. And having an additional certification may or may not make some huge difference.

Many times I see people use it as a differentiator for privileges or something. It's really an external kind of a pressure or a desire, it doesn't really have anything to do with patient care. I mean, Wendy what has your experience been around that need for additional certification?

Wendy Vogel: I've seen it used in practices to merit bonuses, which isn't really fair when a PA does not have that opportunity to have a specialty certification per se. So, I've seen it used negatively. I'm a great believer that any additional education that you can get is beneficial.

However, I will say just like you said, if you are getting your mentoring, you have good practice, you're doing continuing education, then it's essentially the same thing. To be able to have an oncology certification, I had to practice for a year and I had to take a test that really measured what I should know after one year. And that's what a certification was for that. Is it beneficial, do I want it? Yeah, I want it. Do I have to have it to practice? No.

Todd Pickard: I think that is a great way to segue to having a brief conversation about how you bring APPs in? I mean, just at a very high level, should people expect for an APP to come in right out of school and just hit the ground running without any additional investment?

And I could ask the same question about a resident or a fellow who completes an oncology training program. Do you just put those people to work? Maybe that's an older model, and now really mentorship and that additional facilitated work is, I think, critical.

So, I'll start with Stephanie, tell us a little bit about what's your experience been with advanced practice providers, or even young physicians as they enter the workforce? What's the role of onboarding or mentoring program?

Dr. Stephanie Williams: So, it's important. We had a set process for bringing on our new APPs and it pretty much followed the guidelines from the American Society of Cellular Transplantation in terms of the knowledge base that they would need to know.

So, it was a checklist. And we would also have them do modules from ASCO's oncology modules, as well looking at primarily hematologic malignancies, so they could get a background there. And then we would slowly bring them on board.

Usually, they would start taking care of autologous patients, a certain subset of patients, and then move on to the more complicated patients. We did the same clinic, whether they were clinic or inpatient APPs. So, it took us about three to four months to onboard our APPs.

In terms of a fellow becoming an attending physician, I'd like to say that there's specific onboarding there. Unfortunately, sometimes they're just, 'Okay, these are your clinic days, this is when you start.' I mean, you're right Todd, we really need to work more on onboarding people. So, that one, they like their jobs, they're not frustrated, and they want to stay and continue to work in this field. I see many times after two or three years, if they're not onboarded properly, they just get frustrated and want to move on to a different area.

Wendy Vogel: We know that most of the advanced practitioners who come into oncology don't have an oncology background, PA or NP. They just don't, and we don't get a lot of that in school.

So, it takes months, it would probably, I dare say, take 12 months of full-time practice to feel comfortable in the role. But how many practices particularly in the area that I've practiced in you get this AP, and you throw them in there, and in four weeks, you're supposed to be seeing patients.

How can you make those decisions when you haven't been properly mentored? So, absolutely important to have a long onboarding time till that APP feels comfortable.

Todd Pickard: Yeah, I think that it is critically important that we set up all of our team members for success, whether they be physicians, or PAs, or nurse practitioners or nurses, or pharmacists, and I think that is the role of onboarding and mentoring, having people who will invest time and energy in what you're trying to accomplish. You know, Wendy is spot on.

Advanced practice providers have specific types of training within their educational program. As a PA, my focus in oncology was to screen for and detect it. So, to understand when a patient presents with a mass or some symptoms that may make you think that, oh gosh, maybe they've got acute leukemia or something else and looking at those white counts and, and understanding.

But that transition from identifying and screening and diagnosing cancers is very different than how do you care for specific types of tumors and specific disciplines, whether it be radiation oncology, surgical oncology, medical oncology, cancer prevention. There's a lot that folks need to be brought up to speed about the standards of what do we do in this practice and how do we care for these types of cancers? And that really is the role for the onboarding and mentoring.

You know, you may be lucky, you might get an advanced practice provider who used to work at a big academic cancer center in the same field, whether it be breast medical oncology or GI, and yeah, that's a much easier task. That person probably really needs mentoring about the local culture, how we get things done, what are the resources, and which hospitals do we refer to.

But for the most part, working with an advanced practice provider means that you've got a PA or an NP, who has a strong foundation in medical practice. They know how to care for patients, they know how to diagnose, they know how to do assessments, they know how to critically think, they know how to find resources, and they know how to educate. But they may not know how long does a robotic radical prostatectomy patient going to be in the hospital? And how long does it take to recover and what are some of the things you need to be considering in their discharge and their postoperative period?

That is very detailed information about the practice and the local resources. Every advanced practice provider is going to need to have that kind of details shared with them through mentorship, and a lot of it is just how do we team with each other? What are the roles and responsibilities? Who does what? How do we have backup behaviors to cover folks?

So, a lot of this really is just deciding, 'Okay, we've got a team. Who's doing what? How do they work together and how do we back each other up?' Because at the end of the day, it's all about the team supporting each other and that's what I love about advanced practice.

Wendy Vogel: Very well said, yes. I had an AP student yesterday in clinic, who told me - I was asking about her education in oncology and what she got - and she said, 'Well, so for lymphoma, we treat with R-CHOP. So, a student, of course, raised their hand and said, 'What's R-CHOP? She's like, 'Well, the letters don't really line up with what the names of the drugs are, so, just remember R-CHOP for the boards.'

So there you go. That's kind of what a lot of our education was like specific to oncology. And again, I'm a little tongue in cheek there also. But Todd, are you going to tell everybody about the ASCO Onboarding tool that's now available?

Todd Pickard: Absolutely! ASCO has done a really great job of trying to explore what advanced practice is, and how teams work together. All of us are part of the ASCO Advanced Practice Task Force.

One of the things we did was really to look at what are some best practices around onboarding, orientation, scope of practice, and team-based cancer care, and we created a resource that is available on the ASCO website, and I think that it is a great place to start, particularly for practices, physicians, or other hospital systems that don't have a lot of experience with advanced practice.

It's a great reference, it talks about the difference between orientation and onboarding. It gives you examples of what those look like. It talks about what are the competencies and competency-based examinations. So, how you assess people as they're going through the onboarding period. It has tons of references, because ASCO has done a lot of great research in this field, around collaborative practice and how patients experience it, and how folks work on teams, and what do those outcomes look like.

So, I highly recommend it. Wendy, thank you for bringing that up. It's almost like you knew to suggest that.

Well, this has been a really, really good conversation. I'm wondering, what are some of those pearls of wisdom that we could all provide to the folks listening?

So, Stephanie, what are some of your observations that, you know, maybe we haven't just thought about, in your experience working as a physician with advanced practice providers?

Dr. Stephanie Williams: One, it's important to integrate them into the team, and, as Wendy mentioned, to mentor them – mentor anybody correctly, in order for them to feel that they're contributing the most that they can to the care of the patient.

I think there are other issues that we'll get into later and in different podcasts that come up that make physicians hesitant to have nurse practitioners or physician assistants. Some of those are financial, and I think we'll discuss those at a later time. But really, that shouldn't keep you from employing these particular individuals for your team. It really is a very rewarding type of practice to have. You're not alone. You're collaborating with other providers. I think it's just one of the great things that we do in oncology.

Todd Pickard: I wanted to share a moment as a PA, advanced practice provider, when I most felt grateful for the opportunity to work as an advanced practice provider. My clinical practice has been in urology for the past 24 years for the main part. I've had a few little other experiences, but mainly urology, and I'll never forget a patient who was a middle-aged lady who had been working with transitional cell bladder cancer. It was superficial. So, the treatment for that is BCG and repeat cystoscopies and surveillance. And I walked into the room and I was going to give her BCG installation, and she was so angry. I wanted to know what was going on. I thought, gosh, should I make her wait too long or something else? So, I asked her, I said, 'How are you doing today? You seem to be not feeling well.' And she said, 'Well, I'm just so tired of this. I don't understand why y'all don't just fix me. Why don't y'all just get this right? Why do I have to keep coming back?'

And as I looked at the medical record, this patient had had superficial bladder cancer for years. And I thought, 'Has nobody ever really kind of sat down and mapped this out for her?' So, I asked her to get off the examining table, and I pulled the little paper forward, so I had someplace to draw.

And I drew a big square and I said, 'This is a field, just think of any big field anywhere near you. And it's full of weeds.' And I drew some weeds on there. And I said, 'You know we can pull them out and we can pluck them, and we can put some weed killer in that field,' I said, 'do you think that if you come back in three months and there will be any weeds on that field?' She said, 'Of course, there will be. There are always weeds because they always come back. It's very hard to get rid of.' And I said, 'Well, this field is your bladder. And the type of cancer you have are like these weeds, and we have to constantly look for them, remove them, and then put this treatment down, that's why you come.'

And she started crying. And I thought, 'Well, I've blown it.' Because this was in the first couple of years of working as a PA in urology. And I said, 'I'm so sorry. I really apologize.' She said, 'Don't you dare apologize to me.' I said, 'Man, I've really blown it now.' She said, 'Todd, I've had this disease now for this many years. This is the first time I've ever fully understood what's happening to me. I am so grateful to you.'

I will never forget this patient. I will never forget this experience. And I'm extraordinarily proud. It's not because I'm the smartest person in the world. I just happened to investigate, take the time, and I drew it out. I explained it in the simplest of terms because I wanted her to understand. And then whenever she came back, she always wanted to see me. So, it was great. I really developed a really lovely relationship with this patient. It was very rewarding.

Wendy, can you think of a story that you have about an advanced practice provider that makes you particularly happy or where some big lesson was learned?

Wendy Vogel: Yeah. I love your analogy. That's a great analogy. I think that part of what I love to do is similar to you, Todd, in that I like to make things understandable because I consider myself an East Tennessee southern simple person, I want to understand things in the language that I understand. So, I like using a language that a patient understands. I think if I was to say about some of the proudest things, or what makes me so excited about oncology is what we've seen in our lifetime.

So, Todd, you and I practice probably about the same number of years and we could say we remember when Zofran came out, and how that revolutionized chemotherapy nausea and vomiting – Stephanie's nodding here, too. We all know that.

And then wow! When we found out that we could maybe cure CML, that we're having patients live normal lives in our lifetime, that we've seen non-small cell lung cancer patients living past a year that are metastatic – Oh my gosh! This is such an exciting field and we learn something every day. There's new drugs, there's new treatments, there's new hope, every single day, and that's what makes me proud to be a part of that.

Todd Pickard: Yeah, I think that oncology and the work that we get to do as a team is so incredibly rewarding. It's challenging, and we have losses, but we also have wins, and those wins are amazing, and transformative, not only for us but for our patients.

So, some final pearls of wisdom. I'll share and then Wendy, I'll turn it over to you. One thing that I really want to convey to folks is to know about the state that you work in and what are the practice acts for advanced practice providers. Because, unlike our physician colleagues who have a very standard scope of practice across the country, advanced practice can drastically change from state to state and place to place even from institution to institution.

So, be aware of that, so that you can build your team-based practice around what are the constraints, what is the scope of practice, and you can comply with that. It just takes a little bit of pre-work at the beginning. It's not daunting. These things are written in English. We're all smart folks. We can understand them and we can build our teams in the right way.

So, just keep that in the back of their mind. It is not an obstacle. It's the instruction manual of how to build your team. That's all it is if you just think about it simplistically like that. So, Wendy, what's one or two things that you would say you really want our listeners to understand about advanced practice?

Wendy Vogel: I loved what you said, Todd, both of our PA Associations and our Nurse Practitioner Associations have that information online, so it's very easy to find. But I think I would say, don't be afraid to stand up for yourself as an advanced practitioner or as a physician who wants an advanced practitioner. Don't be afraid to stand up for yourself and your scope of practice, know what you can do, know what you can't do, know and demand the respect that you deserve. I would always say that just don't forget that 'no' is the first step to a 'yes,' and keep on trying.

Todd Pickard: I think we can all appreciate that sentiment, whether we be a PA an NP or a physician. Many times, we're advocating for our patients within our systems or our practices or with our payers or insurance providers. And yeah, sometimes you start from a place of 'no' and then you work until you get to that 'yes', or at least a compromise, if you can get to a 'maybe,' that's a good place too. Stephanie, any particular last words of wisdom or wrap us up with our conclusion?

Dr. Stephanie Williams: Thanks, Todd and Wendy, for sharing your insights today. It's always a pleasure chatting with you both. Stay tuned for upcoming episodes where we plan to dig deeper into the various types of APPs, how they are trained, what a day in the life looks like for an oncology APP, their scope of practice, and the importance of team-based care, especially in oncology. Thank you to the listeners as well.

Until next time.

Thank you for listening to the ASCO Education Podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the comprehensive education center at education.asco.org.

The purpose of this podcast is to educate and 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product , service, organization, activity or therapy should not be construed as an ASCO endorsement.

In part one of this ASCO Education Podcast episode, director of the U.S. Food and Drug Administration's Oncology Center of Excellence Dr. Richard Pazdur talks with hosts Dr. David Johnson and Dr. Patrick Loehrer about his upbringing in Indiana, his family, and his circuitous route to oncology. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Pat Loehrer: Hi, I'm Pat Loehrer. I'm the director of the Center of Global Oncology and Health Equity at Indiana University.

Dr. David Johnson: I'm Dave Johnson at UT Southwestern in Dallas, Texas. Pat, great to be back with another episode of Oncology, Etc, an ASCO educational podcast. We have a very special guest today, Dr. Richard Pazdur, from the FDA Oncology Center of Excellence.

I'm really looking forward to this conversation.

Dr. Pat Loehrer: This will be terrific.

Dr. David Johnson: Yeah. You were telling me before we got started about a little event that occurred this week, maybe you want to elaborate on that for us.

Dr. Pat Loehrer: Yeah, we always start out this by talking about books, and one of the books I'm drawn to today is a book called, The Emperor of All Maladies, which was written by Dr. Mukherjee several years ago.

I want to read a little bit from this because it has pertinence. This is about a guy named John Cleveland. Dr. Mukherjee writes, he goes, 'In 1973 Cleveland was a 22-year-old veterinary student in Indiana. In August that year, two months after his marriage, he discovered a rapidly enlarging lump in his right testis. He was whisked off to the operating room for surgery and returned with a scar and he was diagnosed with metastatic testis cancer.

This was right around the time that Larry Einhorn came to Indiana University where he was treated with a three-drug cocktail of actinomycin-D, bleomycin, and oncovin ABO. And then he had a brief remission progressing and was treated with mithramycin mithrymicin.

And then in October of 1974, he once again developed progressive disease, and Larry approached him about a new cocktail with the drug cisplatin, that had never been used before in combination, and Larry's thought was to put it together with another couple of drugs."

So, I'll just finish reading this. "In October 7, 1974, Cleveland took the gamble, he enrolled as patient zero for BVP, an acronym for the new regimen containing Bleomycin, Vinblastine and cisplatin. 10 days later, he returned for routine scans and the tumors in his lungs had vanished. He was ecstatic and mystified. He called his wife from the hospital phone. I can't remember what he said, but I told her the results.

So, John was the first one cured of testis cancer. Back then it was a 5% cure rate. Today, it's 95%. He is really the hero of heroes. Last week, at this time, John had asked me to come to his hospital room because he was diagnosed with metastatic cancer of a different type. He knew that this was basically the final hours of it. And so he wanted to say goodbye to me, and it was the most touching reunion I had.

Two days ago, John passed away. So, my thoughts are with him, especially his family. But also, when we think about heroes, John was one of them, and if it wasn't for him, and his first treatment, Larry might not have gone on and treated other patients with this regimen.

This drug cisplatin was experimental back then it caused a lot of nausea and vomiting and didn't work in many tumors, but this was a drug that was really highlighted and approved for the treatment of bladder cancer so Hubert Humphrey could get treated, and then in testis cancer, and it's really one the really success stories of all success stories in terms of oncology, and it started out with this experimental drug from the NCI that was approved by the FDA."

So, this leads us to our guest today, Rick Pazdur who I've known for many years. He grew up in Calumet City, Illinois, which is famous as the home of the Blues Brothers and Rick Pazdur.

He got his bachelor's degree from Northwestern, his medical degree from Loyola Stritch Medicine, and then did his hematology-oncology fellowship, initially his oncology fellowship at Rush Presbyterian St. Luke's, where I first met Rick, and then later finished his Heme-Onc fellowship at the University of Chicago.

From there, he went to Wayne State, served on the faculty there for about five or six years, and then joined the faculty at MD Anderson. He was there from 1988 to 1999. Then, we'd like to hear about this, but for some reason, it got in his head that he wanted to go to the FDA and so he moved to the FDA where he was Director of the Division of Oncology Drug Products, from 1999 to 2005, when they created the Office of Hematology Oncology Products, and he became the Director of this.

More recently, he's been made the director of the FDA's Oncology Center of Excellence. He still serves as the acting director for this OHOP. Rick is an extraordinary individual. He's been awarded a number of awards. From ASCO, he got the Service Recognition Award and the Public Service Award in 2013. And the AACR also awarded him the Public Service Award in 2015.

He's received numerous awards and he is probably one of the most respected oncologists that I know in this society. It's such a great pleasure to have you here today, Rick.

Dr. Richard Pazdur: My pleasure, Pat. My pleasure entirely. I look forward to the conversation.

Dr. David Johnson: Pat, you left out one award. He got so many awards that you can't list them all, but I was impressed that he got this award for the Massachusetts General Hospital Cancer Center's – The 100 list.

Dr. Pat Loehrer: Yeah, we made the cut-off.

Dr. David Johnson: I have no idea what that is.

Dr. Pat Loehrer: We were on the 1001 list. We made that one. The only thing I want to throw into is that when I first met Rick, when I was a resident or an intern, I think, he was on the service with Phil Bonomi, who is very important for me for my thymoma research, but there was an oncology nurse on the service, Mary Lind, who was a terrific oncology nurse as they all are. But it turned out there was more chemistry that went on. So, Rick ended up marrying Mary, and I'm sure he'll tell some stories. We'll come back to that in a little bit, too.

Dr. David Johnson: Yeah, this is really exciting. So, let's get started. Rick, maybe you could tell us a little bit about your background and what got you into medicine in the early part of your career.

Dr. Richard Pazdur: I had an interesting story. Pat had mentioned Calumet City home as a Blues Brothers. That was the orphanage in the movie. It was located in Calumet City. But what you don't know about Calumet City is that the real kind of nickname for Calumet City in the 50s 60s 40s was 'Sin City'.

It has the honor of having the greatest number of liquor licenses in the United States. And in Calumet City, which was on the border of Hammond, Indiana, and Calumet City, they're kind of Sister Cities. They're one in Illinois, Calumet City. And Hammond is in Indiana, obviously, there was this strip, and it was called 'The Strip' and it had all of these bars and floor shows with Sally Rand and gambling.

If you walk down there, which I never did as a kid, but drove down there with my father some time just traversing the city, those lights were so bright, it was just like Las Vegas, basically.

So, you had that Strip and that went on for maybe three, four, or five blocks. And then you have the rest of the city that I grew up in, which was primarily a Polish Catholic city, which I am kind of a representative of being 100% polish. There were scattered bars throughout the city.

In fact, my fondest memory is sleeping in bed at 3 o'clock in the morning or 2 o'clock in the morning, awakening to people running out of a bar, which was 50 feet or 100 feet from my bedroom window. They were screaming and yelling and cursing and everything and throwing beer bottles at each other. And in those days, obviously, as you remember, in the 60s, there was no air conditioning. So, the bar was called The Tropical Inn. Let me tell you this, there was nothing tropical about it and there was nothing 'in' about it.

Dr. David Johnson: That background might have driven….

Dr. Richard Pazdur: That was not what I would call a highbrow area, but I enjoyed it. It was a fabulous childhood that I had. Most people don't know this. So, I will share this with you because it really had an indelible mark on my life and something that really transformed my childhood and my high school years and my college years, and my medical school years.

When I was about in seventh or eighth grade, my father who was basically a blue-collar factory worker, developed glaucoma, and he went blind at a very early age. And that threw the family into not only emotional turmoil but also economic turmoil.

I survived basically by getting Social Security dependent income and had to work at a very early age. I started as a dishwasher. My mother lied about my age so I could start working at a crummy restaurant in Calumet City as a dishwasher and I worked throughout school, but that experience really made me grow up really fast if I could say so.

You didn't have a childhood, you had to be responsible because there was really no security blanket to fall back on. Although my parents didn't have a lot of money, they really had very good emotional support for me and both my father and my mother came from very large, Polish families.

My mother had nine children in her family. She was right in the middle. And so, I had many cousins and many aunts and uncles and my father had seven children in his family and he was the oldest boy.

So, there was a lot of support there, but obviously not a lot of financial support. So, it really made me grow up relatively quickly and really come to some of life's lessons, relatively fast like discrimination against disabled people, which I will always remember.

When I was a boy, I remember going with my father walking and obviously he had a white cane, but walking down the street, people would actually cross the street to avoid us. They just didn't want to confront that anxiety. I don't know if it was discrimination or if they just felt uncomfortable dealing with it. When you go to a restaurant, people raise their voices, like the man was mentally impaired and that wasn't the case.

Dr. Pat Loehrer: I'm sorry to interrupt you just for a second because I read this somewhere and I think it's important to throw in. So, you graduated from high school in three years?

Dr. Richard Pazdur: Yes, that's what I was gonna say. I graduated and I worked during that time also. These jobs were not like jobs that kids have now as consultants or internships, these were like real jobs as a janitor, a gardener, or a packer in a grocery store.

You had to do it and you had to compartmentalize your life to get things done, basically. But you were driven to do things and I'm thankful for that experience really. I even use it now when I'm facing turmoil in my life. I look back at that time and say to myself, Rick, if you did it then as a 12-year-old kid, a 14-year-old kid, you could do anything.

So, it really fostered a sense of responsibility, self-awareness, and the need to do things for yourself and get going on yourself. because nobody's going to help you in a sense. I'm very grateful for that.

Dr. David Johnson: Rick, at what point did you decide to become a physician? How did that experience really drive you into that field?

Dr. Richard Pazdur: Well, I spent a great deal of time in the lobby of the University of Chicago hospital with my father. I was the primary caregiver and went with him to his doctor's appointments. I can't tell you the number of hours I spent in the lobby of that hospital.

I was very interested in science. I was very interested in really helping people because of that background. I really had a great deal of clarity, though. I remember, when I was maybe a freshman or sophomore in high school, I wrote for the Northwestern Medical School catalog, because I thought I would be going to Northwestern undergraduate, I already decided in my own mind that that's where I wanted to go.

I just got their medical school catalog and I was thumbing through it, and I remember this vividly sitting on my bedroom floor next to the window that was 50 feet away from the bar, basically, and was looking through the medical school catalog and seeing all these names of this doctor, head of neurology, assistant professor, associate professor. I said, "Hell, if I'm going to be a doctor, I want to be one of these people. I want to be the best doctor. I want to be teaching the physician here and doing research."

So, unlike most kids today that have to find themselves, like, 'I'm going to take 8 years to complete college or something like that and take a year off to find myself.' I had to be very, very focused on what I wanted to do.

So, I really worked very hard during it through time. I don't regret it, as I say. I went to Northwestern undergraduate and had a fantastic experience there. I graduated in three years as I mentioned. I had a special interest there that most people don't know about. The people at the FDA know about it. I did these pre-med courses but I had a really special interest in the field of sociology, and actually was toying with the idea if I didn't get into medical school to pursue a Ph.D. in Sociology and become an academic sociologist. If you remember and both of you are of this age.

Dr. Pat Loehrer: David is, not me.

Dr. Richard Pazdur: Okay. David might know of the Vietnam War. This was right around the time of Kent State and closing down the schools, I'm sure you remember that, for the colleges, etc.

Nobody went into business or anything like that. It was a sociology, psychology, and anthropology type of things people were interested in. My love was this field, and I did a lot of research on it.

I remember one of the professors that probably had the most influence on me, a woman called Zena Smith Blau, who was a sociologist, and I did multiple research projects and independent studies. The first thing when I took her first course, she assigned us a paper and she said, write about yourself, 'What makes you unique?

I went to see her and I said, 'I really don't know exactly what you mean by this.' She said, 'Well, how different are you?' And I said, 'Well, my parents are children of Polish immigrants, and I really know the Polish community in Chicago fairly well.' She said, 'That's it Rick, that's what your specialty will be.'

I did multiple research projects on this area with her. Some of them were like the assimilation of Polish immigrants with regard to urban-rural origin. Another one was working-class youth in Chicago, and mobility based on education and high school part-time employment. So, that was a fantastic experience that is totally outside of what I did in my future.

Dr. David Johnson: We asked our listeners to submit questions because we knew you were coming on. We did get a question that perhaps is appropriate to ask at this time. It comes from a younger trainee, who wants to know what advice you would give to a trainee aspiring to have a clinical investigative career in oncology? What sort of preparation should they have?

Obviously, you've got to learn all of the techniques of clinical trial designs, statistics, etc. But what other advice would you give a trainee hoping to pursue a career in clinical investigation?

Dr. Richard Pazdur: I think one's career always has to go back to the basics and have a patient focus. So, what is your interest in the patient, so to speak? And that is what advice I would give them.

Are you interested in a supportive care issue? Are you interested in a specific disease? I think you have to follow a passion and that is what is most important to me. What is your passion in life? Because as physicians, we spend a great deal of time preparing for our careers and then subsequently afterward, in our designated careers, and you really can't approach this as a job. It has to be a passion.

So, if you do have this, what are the questions that you really want to answer? What is the field that you want to go into and make an indelible mark in? So, that's what I come from, and that's something that I tell our staff is: what do you really want to do? What makes you happy? What would make you a success in your mind? Not defining yourself by somebody else.

Dr. Pat Loehrer: Finish the story a little bit. Was it a patient then that turned you on to oncology? What brought you into oncology?

Dr. Richard Pazdur: I had a very circuitous circular route to oncology. Oh my God! I don't know if you have enough time to hear this story, but let me start though.

I originally went to medical school because of my background in sociology. I wanted to become a psychiatrist because here again, I thought psychiatry, sociology, and psychology, these are kinds of things I was interested in until I took my first rotation in psychiatry. It was nothing like I thought it was going to be. I saw my first patient that got ECT (Electroconvulsive Therapy) and I said, 'I ain't doing this.'

So, I was then interested in cardiology. Loyola at that time where I was going to medical school and where I did my internship and residency, had a huge cardiology program that was like CAST city, USA. Everybody was just coming into the hospital getting CAST and going out of the hospital.

Dr. Pat Loehrer: [Unintelligible 18:13] was there, right?

Dr. Richard Pazdur: Yes. Mary Kate [Unintelligible 18:18]'s father was the head of medicine there. And it had a huge cardiology program and an excellent cardiology program. I really did like Clinical Oncology, and I was all signed up for a cardiology fellowship, the Ts were crossed, the dots were placed, the contract signed, and everything.

And somebody said, 'Rick, why don't you take a rotation while you're a resident in the cath lab? We have an opening and this would be a great time and opportunity for you to jumpstart your fellowship. So, you can come and work for us in the middle of your third year of residency for about two or three months.'

So, I did that and I hated it. I just dreaded it. I couldn't stand it. It was the most boring thing. I would think of every opportunity to escape the Cath lab. It was the same thing over and over and over again, inject the dye, turn on the [Unintelligible19:16] machine, and follow the coronary arteries.

So, I happened to go to a community hospital, St. Francis in Evanston, Illinois, and I met an oncologist there that had just finished her fellowship. I really was very impressed by her clinical skills. She had finished her fellowship at the University of Chicago and worked with her there and was just amazed by really the quality of care that the oncologist gave patients with cancer.

Previous to that, I had an interest also in oncology. At Loyola at that time, we had an oncologist his name was Ketty Badrinath, and he was an excellent clinical teacher.

Now that I decided that I'm not going into cardiology, the first problem I have is to find a job and to find a fellowship in oncology. So, I started investigating oncology programs at St. Francis Hospital there. I went down to the gift shop and I said, I want $10 worth of quarters. I went to a payphone, closed the door of the payphone, dialed information, and got every oncology program that I could think of from Mayo Clinic to all of the programs in Chicago.

One of my last phone calls was to Rush Presbyterian. I found that program director, Jules Harris, I don't know if you remember him, and he said, "We have an opening." So, I accepted the position.

At the end of June, whatever it was, June 27, 1979. I started my oncology fellowship program. Now Oncology at that time in Chicago, to give you a picture of it, the largest program in oncology was at Rush. It had a total of 12 people. And the therapy started at Rush around solid tumors really in the endocrine therapies of prostate cancer and breast cancer.

So, it was a different program than most programs throughout the United States that were offshoots of Hematology programs and the treatment of acute leukemia and lymphomas. So, it had a really kind of different orientation.

So, I started my fellowship. And on the first day, I met Phil Bonomi, who had a tremendous influence and still has an influence over me. I know no doctor that I respect most more than Phil. I think the greatest compliment that one could give a doctor is to refer your own family to him. And I've done it on numerous occasions with various cousins and aunts and uncles, etc.

But as you mentioned, Pat, I also had the opportunity to meet my wife. And I met her and at first, we were very good friends and there was no romantic relationship. And then, as time proceeded, we knew that there was something special there. My wife was just a wonderful person.

Like myself, my wife was pretty much a self-made person. She was one of eight children, the oldest daughter. As the oldest daughter, she had to assume a lot of childcare responsibilities, cooking, etc, for all of her brothers and sisters and took care of the younger children. But she was an excellent student. She graduated first in her class. She was a national merit finalist.

I often asked my wife, 'Mary, you're a nurse, are you interested in going into medicine? I'll be happy to work with you to get you into medical school.' And she said, 'No, you want to go into medicine, I want to go into nursing.'

That was her orientation toward other people. It wasn't about the buck. It wasn't about the title. It was about the work of helping other people. I really have to honor her mother and father who gave her that orientation. Of interest, all of her sisters are nurses. Her mother was actually a school nurse, and an original graduate of Rush. She went to Rush Nursing School in the 50s but had to leave because at that time in the 1950s, if you got married, you can't be in nursing school, they kicked you out. So, it shows you how times have changed.

Dr. Pat Loehrer: Well, this concludes part one of our interview with Dr. Richard Pazdur who is the director of the US Food and Drug Administration's Oncology Center of Excellence.

Stay tuned for part two of this conversation where we'll hear how cancer has touched his life personally and will explore the initiatives and programs, he started to improve patient care globally.

Thank you to all of our listeners for tuning into Oncology, Etc. This is an ASCO education podcast where we'll talk about just about everything and anything. If you have an idea for a topic or guests you'd like to see on the show, please email us at [email protected]. Have a good week.

Unknown Speaker: Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes. Please click subscribe. Let us know what you think by leaving a review. For more information, visit the comprehensive education center at education.asco.org.

The purpose of this podcast is to educate and 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

In this ASCO Education episode moderated by Dr. Rami Manochakian (Mayo Clinic), two-time cancer survivor and patient advocate Ms. Samantha Watson and medical oncologist Dr. Lidia Schapira (Stanford) discuss the multifaceted impact of high cancer care cost on patients and survivors. They also review communication strategies and resources oncology providers can offer to help alleviate financial toxicity.

If you liked this episode, please subscribe. Learn more at education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Rami Manochakian: Hello, and welcome to the ASCO Education Podcast Series. My name is Dr. Rami Manochakian. I'm a thoracic medical oncologist at the Mayo Clinic in Jacksonville, Florida.

As today's host, I'll be moderating a discussion on what I believe is a very important topic when it comes to cancer care and its financial toxicity. I am very excited to have two wonderful guest speakers who are joining us today. Dr. Lidia Schapira, who's a medical oncologist with a focus and specialty in breast cancer and cancer survivorship. She's a professor of medicine and oncology and director of the Cancer Survivorship Program at Stanford University.

We also have with us, Miss Samantha Watson. She's a two-time cancer survivor, patient advocate, and Managing Director of Stewardship at Expect Miracles Foundation, which is an organization dedicated to providing emotional and financial assistance to people with cancer. It's a pleasure to have you both with us today.

Samantha Watson: Thank you so much for the opportunity.

Dr. Rami Manochakian: Miss Watson, I'm going to start with you. Your story that I got to learn about is very inspiring. You had cancer twice as a young adult. You've gone through a lot. Can you tell us what was it like to go through that journey with two cancers, and a lot of treatments? Also, during that journey, definitely, you must have experienced a lot of financial and other social challenges. I'd like to hear more about that, please.

Samantha Watson: So, I was a senior in college, and I'd had recurring knee pain that nobody could really diagnose for any reason. And it would come and go throughout my years of college. And finally, when I was a senior in college, I had extensive testing and they found Ewing sarcoma, which I had never heard of.

My mom actually was an oncology nurse at Memorial Sloan Kettering. And so, I don't think it was on anybody's radar screen, but she understood the language way better than I did.

What I came to learn was that Ewing sarcoma was typically diagnosed in boys under 20. And I was female and 21 at that time, and it was diagnosed about 300 times a year. So, I had no frame of reference for this. I had been around Sloan Kettering when I was a kid because my mom worked there, but I didn't know what it meant. I didn't know what cancer felt like. And I certainly did not know anybody else who had gone through it.

But at that age and life stage, I was getting ready for my future. I was looking forward to graduating from college, I was looking forward to living on my own and everything stood still.

So, the cancer was in my leg. When I was diagnosed, I went through nine months of high-dose chemotherapy. I went through a 12-hour surgery. I had to relearn how to walk and did a lot of PT. In that time, my friends graduated and they started moving forward and they started creating their lives. And I sat back and watched.

I spent about four months at home after my treatment for Ewing's and I did my physical therapy. And I tried to figure out where to place cancer in my life as a young adult. And I went back to school and I had one semester left and I started to catch every cold that went around and strep. Just everything that goes around a college campus, I was constantly down and my doctors kept saying, 'Don't worry, your immune system just has been devastated by this chemo and you just need time to recover.'

The day before my 23rd birthday, they did a bone marrow biopsy and found that I had Myelodysplastic syndrome, which was a very early form of leukemia. And a month before I graduated from college, I was told that I needed a bone marrow transplant.

Thankfully, because the search was long, and did not really involve me as a patient, I was able to go back to school and graduate from college. I sort of closed that chapter and had a bone marrow transplant about three months later in August of 2001.

And so, again, I was stuck in the hospital for months and months and months, watching all of my friends, again, graduate, go forward, get their jobs, and go on dates. And I sat back and watched and so my recovery, the second time, was very different because when I was freed from the hospital and able to sort of take my steps forward, I didn't really have anywhere to go. I had already graduated from school, I had not yet started working, and I have a very, very wonderful network of support from friends and family. But I wasn't really sure who I was and what I wanted to do.

So, to make a long story a little bit shorter. I started working for a nonprofit organization feeling like there was something more I was supposed to be doing. One of the things I started to become aware of, in my own survivorship experience, was that the aftermath was really hard. And it was uniquely challenging as a young adult without very much financial stability, or no experience, really in the healthcare system on my own. But also, I didn't have any peers. Everyone that I had gone through treatment with had passed away with the exception of me being one person.

So, I didn't have anyone to ask about this issue of young adult cancer and how to get my self-esteem back when I looked and felt different. And as I was sort of navigating these things, I got a bill in the mail for $275,000, which is an absurd number, anytime. But as a 24-year-old, who didn't really have any money in the bank. I mean, that was just completely impossible.

Dr. Rami Manochakian: Absolutely. Wow!

Samantha Watson: Yeah! So, very, fortunately, again, my mom was my best advocate. She spent two years fighting that bill, but I started to put the pieces together and realize that not only is survivorship hard, but it's financially challenging when you're on your own.

And so, I put those two pieces together and created an organization called the Samfund to provide financial support to young adults once treatment has finished because what I kept hearing was that we all share this experience of feeling like we got pushed off a cliff. And then they threw all sorts of bills on top of us while we were down there.

Dr. Rami Manochakian: Wow! Thank you. We're so glad you're with us after this many years. And you're doing well. That's wonderful, but definitely, I think what you've experienced on the other side, is what's after treatments. Dr. Schapira, we hear that term a lot, we as treating physicians, what does it mean to have financial toxicity and to go through it?

Dr. Lidia Schapira: Well, first of all, I do think that Sam's story is so inspiring, and really illustrates what the lived experience is for so many people treated for and living with and beyond cancer.

I think of financial toxicity as sort of an umbrella term that refers to the harm caused by the cost of receiving treatment for cancer. And the way that people are penalized with all of these bills that reflect a really difficult and broken healthcare system.

I think of it in terms of the pain and suffering in a way caused by the burden of cost. So, there can be material aspects, such as new debt accumulation, selling or refinancing a home, a decline in income, having to take loans to pay for cancer treatments, and even bankruptcy.

But there can also be psychological aspects, such as worrying about paying for treatment and being distressed. And there can be behavioral aspects, such as avoiding care or skipping doses of medications to save money. That is a story that we also hear as cancer clinicians.

Dr. Rami Manochakian: Absolutely. I think you mentioned it, and I couldn't agree more with the burden. I mean, the patients have so much to worry about, the patients and the caregivers, about their journey, fighting cancer, going through treatment, and then adding that extra burden and worrying about day-to-day life, their kids, and their future. Definitely, that's a lot.

Miss Watson, with you with the society or the organization that you're leading, you're getting a lot of calls from a lot of patients who need help. How are we doing in the last decade or so in this field, in this aspect?

Samantha Watson: On the one hand, I take it as a very promising sign that we're talking about it, because when I got that $275,000 bill in the mail, if my mom had not been a nurse and known that system enough to navigate the appeals process and all of that, I would still be paying that bill off, if I hadn't already declared bankruptcy. Nobody was talking about it back then. Financial toxicity was not a term that anyone brought it. Nobody talked to us about our bills.

So, I do think that conversations like this, and many others like it are very hopeful signs that we are headed in a good direction. That said, the costs are only getting higher and the economy is only getting harder, and I think we're starting to see the many ways in which this plays out for anyone who's touched by cancer.

At the Samfund, we were focused on the young adult population. Two and a half years ago, we merged with an organization called Expect Miracles Foundation, and we still provide Samfund grants to young adults. But we also provide funding for innovative cancer research and hear from thousands of people every year who are diagnosed with all sorts of cancer diagnoses at all ages.

One of the things that have become very clear to me is that young adults face financial toxicity in a unique way because they have a lot of things stacked on top of each other given their age and their life stage. But the issues really aren't unique to young adults at all. I think what we have seen is that financial toxicity affects essentially anybody who is diagnosed with cancer and/or as you said, is that the caregiver or family member and is directly impacted in that way too.

So, I think, on the one hand, the problem is getting worse, but I do think it's hopeful that we're getting closer to finding solutions and at least a willingness to talk about this.

Dr. Rami Manochakian: Thank you! Dr. Schapira, we live in an era of hope for patients with cancer. The number of drugs, the number of procedures or advancements in science, the research, and education really are great, and we're helping many patients live better and live longer. But that's of course, coming at a cost.

I'm a lung cancer specialist. Half of our patients now with advanced cancer have their cancer harbor mutation that we prescribe some great treatments, very effective, but very expensive bills. I think when we talk about financial toxicity, there are so many aspects, there are the drugs, the pills, the infusion, the scan, and employment, can I keep up my bills? What can you tell us about the different aspects of financial toxicity?

Dr. Lidia Schapira: As you say a lot of innovation is associated with a high price tag, and rising healthcare costs are being increasingly offloaded to patients by ways of rising premiums and out-of-pocket costs.

So, when you talk about targeted treatments that bring a lot of hope, we also have to remember that with a rising number of prescriptions, some of the drug plans have tiered formularies, where expensive specialty drugs typically fall into the highest tier.

And so, patients are often responsible for a percentage of the total cost of the drug, as opposed to a fixed co-payment. So, if we get more granular about this, we can say some of these drugs may cost in excess of $10,000 a month and are covered through some of these outpatient prescriptions as part of a health insurance plan.

But in such cases, a patient who has a tiered formulary that requires a 20% coinsurance for a $10,000 oral cancer drug may have an out-of-pocket cost of about $2,000 a month. I'm just putting some figures to this because these numbers are very hard to manage for so many of our patients, and we're all in a bind. We all want this to be different. But this is the reality that we as oncology clinicians, and our patients and families face every day.

Dr. Rami Manochakian: Absolutely. Thank you. We want and the patient wants the most effective treatment, regardless of cost. But then how can we integrate that into our shared treatment decision planning or making?

Samantha Watson: I do think that there are things that we can do, I think it's really important to recognize that this is the responsibility of a group. It is not just a provider's responsibility to bring it up, because then as Dr. Schapira was saying, you have to know the details of every individual patient's insurance situation, and income situation, there are just so many variables that can affect people. And it's unreasonable to expect any one oncologist to keep track of all of that. So, as a patient, I recognize how big that ask is.

At the same time on the patient side, I think it's one of these situations where patients don't know what we don't know. And as someone who is diagnosed with cancer, especially at an age when I have never had to advocate for myself before, I wouldn't have even known what questions to ask, I think when your doctor says, here's the drug I'm prescribing, you take it. And I think that even now, with all of the research that's been done, and all of the focus on financial toxicity, still most patients' inclination is to trust their doctor and not ask, is there a more affordable option, because there's still this perception, as you said that the most effective treatment is also the most expensive and nobody wants to sacrifice their chances of survival to save money.

And so, I think in the end, this is a group discussion. I think there need to be financial navigators or patient navigators, if they are available to the patient.

I also think that patients, caregivers, partners, parents, children sometimes, depending, can also be part of that conversation because, in everything that I have learned in the last 20-plus years, I still think that had someone tried to talk to me about my bills too early, I probably would have tuned it out. But that's not to say those conversations aren't important and sometimes somebody else in the room who can hear it better.

And so, I think if this is a collaborative effort on the part of patients and providers and family members, and other professionals within the hospital, then absolutely it should play a part because there may be other ways to either manage the high cost of treatment or lower the cost altogether. And sometimes it requires getting creative, knowing if somebody is going to need to take time off work for these treatments or to deal with the side effects that could have a devastating effect because, in the end, financial toxicity isn't just about the cost of treatment. It's about the full financial impact with many moving parts and employment is one of them.

So, I think it's really important also that this is an ongoing conversation, this is not a one-time conversation and people's situations change, and the ability to hear, and process information changes depending on where the patient is and how they're feeling on that day. And so, I think this is certainly an ongoing effort, but also has to include more people than just the provider and the patient alone.

Dr. Rami Manochakian: I love it! I couldn't agree more. Here is a caveat or challenge, which I'm going to ask Dr. Schapira. As an oncologist. I couldn't agree more with what you're saying, but I don't know and maybe a majority of oncologists, Dr. Schapira, we don't know a lot about the cost, at least upfront, we know the drug is cost like this, or the scan or what's going to happen, but an individual, we don't know what's the patient insurance plan.

I feel sometimes that I'm not able or equipped to discuss the cost of care up front. And that sometimes could create friction, because maybe we owe it to our patients to discuss. So, what do we do as oncologists or as oncology healthcare providers as a team?

Dr. Lidia Schapira: You ask a wonderful, multifaceted question. So, the first thing I would say, and what I've spent my entire career doing is we need to be empathic listeners. And we need to create a safe space in our consultation and exam rooms so people can tell us what's on their mind.

So, we may not be able to fix it but we need to be able to talk about this, if it is burdening our patient, just as we talk about any other toxic effect of the diagnosis and treatment. That's one thing we can do. We can do that by routinizing the conversation by asking at multiple points when somebody is ready, or before they're ready, perhaps talking to somebody in the family, we need to be thinking about it. But I think that it's complicated for us too because we are also stakeholders and we also are committed to treating patients with beneficence and advocating for justice, and we see all the harm that's been caused by the system where all of these burdens are placed on people at their most vulnerable time. And we all think it's not particularly fair.

So, I think that part of the conflict for us is that we feel we could do more for each patient. We feel we would like to do more collectively for all of the patients under our care and the care of our colleagues.

So, I think that part of that sensation, a feeling that we don't have sufficient power to fix it, may get in the way of us really collaborating in an open and empathic way with our patients who are experiencing these issues every day. We can think about what tests we order. We can think about the co-payments for the imaging tests. We can think about talking about whether or not they can afford those ancillary medications that we prescribe with great intentions to make their life more bearable.

So, there's a lot we can do. There's a lot we can do. I think we need to support each other. We need to link arms and advocate together for a more just system, but we can't not do anything about it.

Dr. Rami Manochakian: Thank you. This is, I think, very important. It really struck me when you say, look, even if we don't know, well, we're going to talk later on about resources and referring patients. But I do think that patients would like to see their oncologist or hear their oncologist or their treatment providers, or caring providers bring up the cost.

I think just like we asked them about their side effects and about how are you doing and what's happening and quality of life. I think bringing that up, making them feel that we are with them on this journey, even in these details, which often don't come and I'm sure many of our listeners are interested in asking what resources are out there?

Of course, each institution may have its own resources. But, generally speaking, what should we tell our patients? Where should they start from the patient caregiver? What resources are available to avoid or reduce financial toxicity?

Samantha Watson: I think in order to answer that, I also want to reiterate something that Dr. Schapira said from the patients' side, because I think that oncologists don't have to have the answers, that is obviously asking way too much.

I think sometimes just bringing it up or acknowledging that there is a cost to this and that it is going to have an impact on someone's life is exactly the validation that a patient needs because culturally, we don't really like to talk about money. We're not really all that comfortable talking about illness either.

And so, when you put those two things together, it is a conversation that nobody wants to have. And so, what we hear from thousands of patients every year is that they are so ashamed by all of this. They feel like they have done something wrong. They feel like their doctors aren't going to get paid if they have an outstanding balance. And there's so much just misperception about how all of this works. I think just to bring it up to a patient to acknowledge it is so critically important.

As one example, when we were trying to find ways to tell the story of young adult cancer and financial toxicity at the Samfund, we ended up using 'Cancer isn't free', as our tagline. And when the team of volunteers who came up with that presented it to me, I actually cried, they will tell you that I cried in a meeting when they told me that because it was exactly what we needed.

I think, especially in the survivorship. Everyone, patients, family members, and friends assume that you're cancer free, and that, therefore you're fine. And so, to flip the script a little bit and say, 'Well, wait for a second, cancer isn't free,' opened up so many conversations.

We certainly didn't get any closer to lowering the cost of cancer, but not carrying around the weight of this shame and just fundamental discomfort in asking for help after treatment especially, it just opened up more conversations, and we saw so many young adults and other people take a deep breath.

And so, I think bringing up these conversations, even if they don't lead to immediate solutions is a really important first step. And so, with that in mind, I would say that any nonprofit hospital has to have a financial assistance program. They don't always advertise it very well and they don't always make it very easy to find on the websites. Some hospitals do a better job than others, but these programs are there.

The parameters vary, as you said, depending on the hospital and its resources. But I think as a starting point, anyone who's interfacing with that patient should at least say, 'If you're struggling financially, if a bill comes in that you don't know how to handle, please give a call to this.' It can either be the patient assistance program, a financial navigator, whatever your particular hospital calls it, and just give the person the resources that they can access it when they're ready.

So, I think that's a really important first step and a doable one, because it's a referral, nobody has to become an expert in that particular program just to know that it exists and to share that contact information.

The other thing I would say is that there are many, many more patient advocacy groups now than there were 10 years ago, and certainly than there were 20 years ago. And so many of the people that find us as one example, find us in a Google search.

So, anyone that is looking for help with finances, help with bills, cancer bills, I mean, there are all sorts of combinations of words they can search for, they will find the groups that they need. They just don't always know that they're supposed to search for it.

I think, again, bringing up this conversation, whether it's put in clinical terms like financial toxicity, or more informally, like, 'Hey, how are you doing? How's your job? How's your stress level?' Trying to gauge what their biggest challenge is, can sort of inspire them to go home and seek out the resources they need. But until these conversations even start, they don't know what they don't know.

Dr. Rami Manochakian: Absolutely, thank you! These are very helpful. Dr. Schapira, on our end, the providers, what tools and resources can we go to help us, clinicians, discuss financial toxicity more comfortably with patients?

Dr. Lidia Schapira: First, I would say to be comfortable in just talking about it and being open and receptive. The second is to build some expertise in the team. We don't have to carry this. We need to be part of the solution but we don't have to have all the fixes.

I think the idea of financial navigation is gaining traction with our colleagues. There are some people who actively are embarking on research, including a very interesting randomized control trial of a financial navigation intervention that's currently underway.

So, I think that we need to have people who are available to us that we can call, who can help patients understand their bills, who can help patients find sources, perhaps that can help them with payment, to find the nonprofits or charitable organizations, that can help them fill out forms, help them with legal aid, if that's what they need, help them apply for pharmaceutical assistance or health insurance.

All of these are very concrete tasks, and we need to have some capacity in a cancer team to deliver these. And I think for us, as oncologists, what I would love to leave us with is the idea that we can't wait. There is an urgency of getting all these things implemented. And we can do it in any number of ways, but it's something we absolutely need to deliver to our patients.

Dr. Rami Manochakian: Absolutely. Thank you for bringing that up. As you both mentioned, it's very good that we're talking about it more. I'm remembering a patient of mine who told my social worker, and kudos to all the wonderful social workers and case managers out there, these patients advocates out there are a very important part of the team, not just the doctors, the nurses, the others. They're looking after the patient in so many aspects.

I remember my social worker telling me, well, the patient did say, 'Please don't bring this into much detail to Dr. Manochakian.' And when she asked her why? And she said, 'Well, because I don't want him to worry about that part. Let us worry about this part.'

That struck me. The patient doesn't want me to worry about her or his financial toxicity. I mean, of course, we need to but I don't want to make it sound like the sky is blue. That, yes, that should be something easy.

No, it's not easy. An important challenge is time. A lot of time the social worker would tell us, 'Well, we also understand that you don't have time for it. Your visit with the patient is 30 minutes or an hour. We do know that in the community, sometimes visits are shorter, you don't want to just ask and then change the topic. And if you ask for a candid conversation about financial toxicity, it's gonna take time. Where do you have that time?'

So, I don't know. Dr. Schapira, if you have a solution for that, or an idea because it is, I think a major challenge is time and this is maybe where the social worker and other people help. But this conversation needs time and there is in this day and age in health care, there is not much time.

Dr. Lidia Schapira: My short answer to that is we need to build teams that have the capacity to absorb these issues, just as we've learned to deal with other difficult conversations and other difficult topics that are such an important part of people's lives.

And remember that this just doesn't affect cancer care. There may be other specialists, there may be primary care physicians who were also there trying to assist patients and families, and there may be other decisions that are linked to whether or not they receive cancer care, or what kind of cancer care they receive.

So, I think that we're all in this together and my take home is that we all need to have this capacity in our settings wherever we deliver cancer care.

Samantha Watson: One thing I would add also is that cancer is not a single appointment, right? We all know that. I probably spent more hours in the clinic, the years of my treatment, than I did in my own house.

So, we have a lot of opportunities to do this. I'm thinking about the many days either inpatient or outpatient, when, for example, a nutrition specialist would come and see me because I couldn't eat and my weight was dropping, and everybody was concerned about that. And on some days, I just didn't want to hear it, I wasn't hungry, I couldn't stomach whatever she was trying to give me. But on other days, I took it and was ready to try and put the weight back on and take her suggestions, and I was just in a different frame of mind.

And so, I think that if there is a social worker, a financial navigator, somebody who can make some of these referrals to organizations and to assistance programs within the hospital, that even joins one of the appointments for the last five minutes, or pokes their head in every so often to check-in. We have a lot of different opportunities to do that because most people also are spending time inpatient. And so, I think this probably also is a learning opportunity, right? We see what works. And we see we will learn from this because we're figuring this out in real-time. And hopefully, five years from now, 10 years from now, we will look back on this time when we started to have these conversations and try out different strategies and get to the root causes of some of these issues, and we will have figured out solutions. But I think for right now we just need to try.

Dr. Rami Manochakian: Well, thank you. This has been really very insightful from both of you. I really appreciate everything you share today. As we are reaching the end of this podcast, I'd like to ask each one of you to give all these wonderful patients and caregivers, anyone who's involved in cancer care out there, a final message. I'll start with you, Miss Watson.

Samantha Watson: One of the things that we have touched on in this conversation is that financial toxicity is not limited to the cost of treatment, and therefore the experience is not only felt while someone undergoes treatment. It extends well into survivorship. It extends to employment issues. It extends especially for young adults to family building challenges, which can be very expensive. And this is an ongoing issue but the thing that I would leave people with is that there is a way through it.

I have done this work for 20 years. I have heard thousands upon thousands of very similar stories, not just about profound financial struggle, but about resilience and about determination. And if this is just a matter of connecting the dots, and we know that there are some resources out there, we have to make sure patients know about them. We have to arm providers, social workers, and other professionals with the confidence and the information to share but I think if we can do that well, and when we do that well, we have already seen that, especially in the young adult community, which is the one that I know best, so many of these incredible patients go on to live very happy and wonderful lives.

And if I have an example, I had my bone marrow transplant almost 21 years ago. I have dealt with plenty of side effects and a lot of bills. I've been happily married for 15 years. I have a career that I love, and I'm a mom to two beautiful children. So, with the right support, and with the right mechanisms and conversations in place, people absolutely can move forward through this.

Dr. Rami Manochakian: Thank you! Dr. Schapira?

Dr. Lidia Schapira: My final comment is that we have learned a lot through research and through conversations, we know that there are some who are at greater risk for financial toxicity and harm, and those who are the younger patients are the ones with lower income, particularly black rural patients.

So, we need to redouble our efforts. We need to do this with compassion. We need to do this as part of the work that we do. We need to involve people who have special expertise in this and bring them into our cancer team. And we too, I think, need to feel that this is a general fight that we all need to get involved in to make cancer treatments, and particularly the novel, cutting edge cancer treatments more accessible for everybody who comes to our care, and without burdening them for the rest of their life with the consequences of treatment.

Dr. Rami Manochakian: Thank you! You couldn't have said it any better. I do like to mention here also since this is an ASCO podcast, I'd like to highlight the efforts by ASCO, the American Society of Clinical Oncology, and many other societies to be fair out there in their advocacy efforts with Congress, with the government about what can be done more also at a higher level to try to increase access in more effective, more affordable health care. And this was very insightful. I'm positive, it's very helpful for many listeners, patients, and caregivers out there.

As you both mentioned, to further highlight the importance of keep talking about these topics, to tell every patient out there that help is there. But you need sometimes to remind yourself to ask for help. Don't be ashamed of talking about financial toxicity, bring it up. We as healthcare providers know we're not doing a great job yet at it, but we need to help each other patients and healthcare providers, and all the team members to talk about this topic more and see how we can help.

The conversation needs to be continued about financial toxicity for patients, cancer survivors, continue to communicate, share the resources, and definitely, I think the future will be better. It needs time, but hopefully, we can get there slowly. Thank you so much, both of you Dr. Schapira and Miss Watson. Thank you so much to our wonderful ASCO staff. Thank you to our listeners. We appreciate you tuning in to this episode of the ASCO Education Podcast. Have a good day everyone.

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In the second of this two-part conversation Drs. Patrick Loehrer and David Johnson sit down with Dr. Deborah Schrag, the current Chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center to continue the discussion of her roles as a leader, researcher, oncologist, public health expert, and more.

If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Dave Johnson: Hi everyone, welcome back to Oncology, Etc. an ASCO educational podcast. My name is Dave Johnson. I'm at UT Southwestern Medical Center in Dallas. And I'm here with my good friend Dr. Pat Loehrer who serves as a director of Global Oncology and Health Equities at Indiana University. In the second half of our conversation with Dr. Deborah Schrag, the current chair of Medicine at Memorial Sloan Kettering Cancer Center in New York.

In part one, we heard about Dr. Schrag's early life and background, as well as the importance of affordable cancer care and much more. Let's jump back into the conversation and hear about her current goals and initiatives at Memorial Sloan Kettering.

I have a question for you. Jumping ahead a little bit. But I mean, you're such a role model for all of us. But you're now in a very powerful position as head of medicine at the preeminent cancer center in the world. So, I'd be interested in knowing what are your top initiatives? What did you come to this role wanting to do short-term and long-term? I'd be curious to hear from you about that.

Dr. Deborah Schrag: Yeah. So, I have lots of specific initiatives, all the things that are probably very similar across medical cancer centers. We have to figure out the role of immuno-oncology. We have to figure out the role of CAR T-cell Therapy.

There are lots of specific things, but let me tell you about three sort of overarching principles and things that I think we need to think about. So, one of the reasons why I decided to leave my job where I really focused on training researchers and building a research program to lead a department of medicine that has a mix of clinicians, educators, and investigators is that there's really a profound sense of exhaustion and disconnection. I'll use the word even burnout or people get the sense of losing the joy in the practice of medicine.

And as corny as it sounds, and I know I'm going a little corny here, Dave. But I really want to help bring back and connect people to the joy in the practice of medicine. It's the joy that we experience when we crack a tough case, when we help a patient, when our patients make us laugh, when our patients and their families make us cry, when they drive us bananas, when they cook us food that is inedible, just reconnecting us to the joy, to the stories.

I really wanted to try to be a different kind of leader because I felt that I could make a contribution to the field of academic medicine in general and oncology in particular, by working with faculty to set them up to tap into that joy, because I know they all started with it. I know they all went into medicine because they care about those human stories, because they do want to make a difference.

This past week, a fellow intern of mine who you may know, passed away. His name was Paul Farmer. He was the head of Partners in Health and he was an infectious disease physician. There's a book about him by Tracy Kidder that's really moving. There's also a documentary about him called, Bending the Arc, which I would highly recommend.

Paul was an incredible inspiration, just incredible, but he brought so much joy to the practice of medicine. I remember when Paul was going to some of the poorest places on the planet, specifically Cange, Haiti. He got an idea that he needed to bring chemotherapy because there were large cancers that were untreated. And he wanted to get leftover chemotherapy from the Dana-Farber.

So, in the 1990s, when I was a fellow, he would ask me whether I could get him any leftover Taxol. I was like, 'Paul, I can't do that. It's not safe. You can't take leftover Taxol to Cange'. And he said, 'Deb, just wait, the drugs will be oral soon, and then I'll get it'. But guess what? Paul came back to me in 1999, and capecitabine had been approved. The oral equivalent of 5-FU. He held my feet to the fire. He said, 'Every time you have a dead patient, if there's any leftover capecitabine, I want you to get it for me'.

Inspirational leadership, connecting people to the joy in the practice of medicine. I would say that's number one. There's no one simple formula or way to do that. It's hard work. It requires a team I think a lot more teamwork into the practice of medicine. I think we're coming out of a hard two years where we've been confined to Zoom boxes. But it's a lot easier when we can sit together in a room and have a pizza and a beer on a Friday afternoon. But we have to figure this out, and we will, step by step.

The other big thematic area, I think, has to do with the patient experience. Dave, I mean, when I started out as a fellow, patients with advanced lung cancer were living for 10 months, 10-12 months, that was a pretty good run with advanced metastatic non-small cell lung cancer.

Well, these days, it's 2-3 years, and there's even quite a tale of patients who were living 4-5 years. And that is a long journey. It's no longer the 800-meter sprint, it's a half marathon, turning into a marathon and even an ultra-marathon. So, the way we deliver care needs to change.

So, we're really rethinking here, how we deliver care. So, as an example of some, if you go back to the 80s and 90s, cancer chemotherapy was something that happened in the hospital. And in the last quarter century, we've transitioned that to an outpatient practice. I think in the next quarter century, we won't transition all of it, but we will transition a lot of it to home.

As an example, I'm struck by when patients undergo IVF, they get handed some Lupron and are taught how to self-administer Lupron every day, so they can undergo a fertility cycle. But when those same women get breast cancer, they have to come into the clinic and sit and wait and take half a day off of work to get the same Lupron. The same is true for men with prostate cancer. Why is that? It's because of policies, and it's not safety, it's not patient-centered.

So, I think we have an opportunity to change the patient experience. I think we'll be able to give immunotherapy at home, and HER-2 agents at home. We have to do the trials and make sure that it's safe, but we have to make cancer care more patient-centric and improve the experience. And that's just essential when it's a marathon that we're asking our patients to run, not these 12-month sprints. Families need this also. So, those are a few of the challenges that I want to take on. Joy in medicine, patient experience, and of course, the physician-scientist pathway needs to be strengthened.

Dr. Pat Loehrer: I love it. You can imagine between Dave and me, I think that resonates so much about having joy in medicine. I've not heard other people talk about that, but I really think that's an important vocation. But I'm going to ask you something else too because, in the efforts of being joyful and being a role model for that, there's the other side of it, where you can't actually let your hair down, and really be depressed, if you will, or down because you can't let the other side see that.

And so, who do you lean on if you will, your confessor that you can talk to when you're feeling down when you're trying to fight the anti-joy part of your job?

Dr. Deborah Schrag: I have lots of friends outside of medicine. And I've always found that that's really helpful to make time for friends outside of medicine. They help connect me to humor and other things. I'm coming up on a big high school reunion. My high school classmates and I still meet for picnics in Central Park. And there are about 120 in our graduating class. And I think we'll have about 110 of us getting together. We still have picnics with 40-50 people attending.

So, there's nothing like old friends from childhood who now do all kinds of different things. So, that's really helpful. But I've also found that my mentors and colleagues who trained me and who know me really well, are a great source of advice.

So, leaders in academic medicine, and I've always found that I've been able to get advice from people who were senior and leaders, people such as Dr. Mayer, Dr. Benz, Dr. Jim Griffin, and also junior colleagues.

I now increasingly as I get old, I rely more and more on my trainees and my mentees. So, some of the folks I know best are people who I trained. So, I'll just give you one example. Many of you may know Ethan Basch. We worked together when we were both just coming up. I was an assistant professor. He was a couple of years behind me. I mentored him.

Well, he's now chief of the Division of Oncology at UNC. He and I have written lots of grants together. We're really partners now. But it's been a lifelong professional friendship. Sometimes when I just need to let my hair down, I get on the phone with Ethan, and yeah, there's a little bit of commiserating.

But I'll give you an example that runs through Dave. Some really valuable experiences had to do with being asked to serve on committees. I think it's great. I just want to give a shout-out to ASCO. Some of my earliest professional relationships were with superstars that I met through ASCO. So, people like Joe Simone, reading his Simone's Maxims everyone needs to read Simone's Maxims if you haven't. There was a guy by the name of Christopher Desh, who sadly passed on. But he was an ASCO member who practiced at the Virginia Commonwealth University back in the late 1990s. Boy, did that guy understand the joy in medicine, some of the early folks who started QOPI.

Being introduced to those individuals who practiced in different parts of the country and who had different kinds of challenges - having that sort of rich network has been incredible. At some point, I think through such a connection, maybe it was through Dr. Mayer, I was referred to Dr. Johnson, who was then running the American Board of Internal Medicine committee that wrote the oncology exam. I participated in that for a few years that was led by Dr. Johnson.

And I met incredible people on that committee, including Dr. Johnson, just Dr. Johnson's stories could inspire anyone and get them back on track just in terms of the humor and the joy and the love, and really the pride in the profession. But I met Jamie Von Roenn that way, who's now leading educational efforts at ASCO, she was on that committee. Lynn Schuchter became a good friend of mine as a result of that.

So, I would just say, sometimes you need to get out of your own space. And sometimes I need to get out of Dodge, as they say, I need to get out of New York, get out of Boston, and being connected to colleagues across the country has been so rewarding.

I have a network of friends at other institutions who I rely on. Serving on external advisory boards is a great place to meet people. Study section, if anyone has the opportunity to be on study section. That's a fabulous opportunity.

So, I think participating in peer review, showing up at meetings, serving on ASCO committees, or ASH or AACR. These are really important experiences. And I will say in my leadership role, I'm really trying to make it clear to faculty that I encourage them to take time to participate in these activities and attend these events and even travel because the traveling is important, too.

I could not have gotten the same dose of Dave Johnson, if I had not actually gone to the meeting, spent all day writing board review questions, and then having a nice meal afterward. That was part of the experience. I don't know what you would say, Dave, but that was my view.

Dr. Dave Johnson: So, one of the things that Osler talked about was the fellowship of the profession, and how important it is to have those relationships. Even if one can't physically be with that individual, developing that spiritual relationship is really critically important. I'm so glad you brought this up and expanded on it in the way you did because I think it's absolutely critical to retain the joy of medicine. It's our colleagues, as well as our patients that make it such a marvelous, majestic profession, in my view.

Dr. Pat Loehrer: I was going to just add something if I could. So, Deb, replace me on the ABIM, just to let you know, because we had certain slots on there. One of the not sure if it was the rules or guidelines that were mandated is that everyone needed to take the oncology boards, even though we wrote the questions, we had to take the test. And you knew that and you had such unbridled enthusiasm for this.

I still remember this deeply, and that not only did you recertify for the oncology board, but you also studied to take the medicine boards too. Your love of medicine is so contagious. And I'm sure everyone at Memorial benefits from this.

Dr. Deborah Schrag: Thank you. That's very nice to say. I do, I love the stories. I've been rounding with the house staff on the inpatient service. I think both of you know, inpatient oncology, as we're able to do more and more in the outpatient setting, our inpatients are very, very sick. And we often get a front-row seat to what I would call the social determinants of health challenges.

In other words, if you've got relatives and resources, you may be able to be at home. But if you have severe pain or symptoms, and you lack the relatives, or you live on a fifth floor, walk-up, or just don't have the resources to get the home care that you need, you're more likely to be in our hospital. But as I round with the house staff, I find myself asking them to tell me more about the patient stories. Because when I round and they tell me that it's a 74-year-old with peritoneal carcinomatosis, jaundice, and abdominal pain. I'm so old that I've seen so many hundreds of those patients and the management hasn't changed very much. But what's really the privilege is to understand the journeys that got people where they are, and to learn a little bit about who these people are.

I try to do that when I round with house staff and I find that it makes the experience better for them. I have to say that I do worry about how we train young physicians in oncology because what they see on the inpatient side is really the hardest of the hard, that's obviously less true in a leukemia service, where they're delivering lots of curative therapy or a stem cell transplant service. But in solid tumor oncology, it's really hard. I think it's something we have to have to tackle. We have to rethink education and medical oncology. I'm hoping that we're going to do that. That's also on the bucket list, by the way. I think we have to do that as a profession. And I know both of you are passionate champions and advocates for education, as is ASCO. But I think it's really imperative that we do that if we are to keep attracting talent.

And then I just want to make one more point, which is that New York City is one of the most diverse places in the United States. I don't know about the planet, because I don't know the whole planet. But in the United States, we are incredibly diverse. But the oncology workforce does not yet look like that.

So, we have a lot of work to do to train a much more diverse workforce. We're doing well with respect to gender, very well. We're literally about 50/50, we may even have a little bit higher proportion of women on the faculty here at MSK. And I think that's true nationally as well. But with respect to Blacks and Hispanics, and other underrepresented communities, Native Americans, we've got a long way to go. And we have a pipeline problem. And that's going to be hard. But it's hard work that we have to do, and I know you guys are working on that in your own centers as well.

Dr. Dave Johnson: Let me follow up on that. What attributes are you looking for in trainees and newly hired faculty? Whether they be junior or senior faculty? What are the characteristics or attributes you seek that you think predict, or certainly you want your individuals to possess?

Dr. Deborah Schrag: We all want people who have everything, but I would say creativity, the willingness to take risks, and the ability to ask a question. I say this to the trainees, frankly, I say it to my own children as well. 'It's okay, take a harder course.

Yes, you may get a B minus by trying something new and different, that doesn't play to your strengths. But try something new. Take risks. Yes, the trial may fail. Yes, you may not get that grant.' But I think a willingness to take risks, a willingness to put yourself out there, a willingness to stretch. I'm also looking for people who can work in teams because there is no aspect of medical care that happens in MSK, I suspect that it's also true that maybe medicine in Antarctica, but even medicine in Antarctica is probably a team sport.

Medicine has become a very complicated team sport. It's a very complicated dance with pharmacists, nurses, and APPs. It takes a village to give a course of immunotherapy. It is very complicated.

And so, when people like to control things and like to do everything themselves, they're going to have a hard time. And that's true I find for teaching, laboratory investigation, wet lab, dry lab, most good, impactful, important science in oncology these days, clinical trials, wet, dry, all of it gets done in teams. Teams that have people with different levels of training, different skill sets, early stage, late stage, people who are quantitative, people who can write, people who can program, people who can do lab experiments, and people who know what an organoid is. People who know how to program an in R. All different kinds of skill sets but they have to be able to work in teams.

People who can't do that are going to struggle to achieve maximum impact. I'm not saying that there isn't room at the end for the occasional genius person who likes to work solo. But that's not really what we need to move the needle.

So, I need team players. I think there is a big emphasis on collegiality. Of course, we want smart and we want brilliance. But sometimes a drop less brilliance and a drop more collegiality and being able to work together in a team, it goes a long way and it's the difference between doing something impactful and not.

That's what I look for. I also think that it takes all different kinds of people. And no one has to excel at everything, but it's great for people to be able to excel at something. So, passion, drive, and ability to ask questions, and not being afraid to occasionally fail and having some tolerance for that and trying to make sure that leaders are able to tolerate that, too. We have to be able to.

Dr. Dave Johnson: Yeah, I think those are great suggestions. We're getting near the end of our time today, and we have a lot more questions to ask. But what's your biggest fear, as the head of the Department of Medicine, looking to the future, what causes you to lose sleep at night?

Dr. Deborah Schrag: I think the business of medicine. If medicine turns into something that feels just like [inaudible] work, and losing physicians, if we don't respect physicians' need to take care of themselves, to take care of their families, and yeah, to find that joy, then we will not attract the top talents.

I think we need great minds and great hearts and people from all walks of life to enter the profession, because that's the talent that we need, to quote my friend, Paul Farmer, 'Bend the arc'. And you know, we need to bend Kaplan-Meier curves in the right direction. And we need the talent to come into the profession, and if they see that we are not happy and not thriving, the next generation is going to go elsewhere.

I don't want to begrudge my wonderful endocrinology colleagues. We need people to tackle diabetes, and we need great surgeons and great anesthesiologists, too. So, it's not just oncology. In medicine, I'm responsible for all kinds of discipline. And boy, we need a lot of cardio-oncologists because we've created all kinds of new challenges.

So, it's all of the sub-disciplines of medicine, but I think physician well-being and attracting talent to the field is really essential and making sure that the business side of medicine doesn't take over and destroy the core promise and premise of academic medicine. It is a spectacular profession and calling, and it has led to so many advances that have really changed the world. And we have to, I think, preserve the good in that. My fear is that that gets further eroded.

Dr. Pat Loehrer: Just one last question from me. Thank you for all your wonderful comments. But I think I have to ask this because it's such an unusual thing as they brought up at the beginning that you're the first female Head of Medicine at Memorial and Lisa DeAngelis is the first Physician in Chief.

And so, although there is gender equity in medicine, there is not gender equity and leadership around the academic world. And this is a very unique situation there. Can you reflect a little bit about the significance of this and perhaps, lessons learned, particularly if you're speaking to a younger version of yourself or a young woman who's thinking about a career? What are the lessons between you and Dr. DeAngelis mean?

Dr. Deborah Schrag: I'm not sure I've been at it long enough to have lessons. I'm just so grateful. So, I'm not in the generation that was a trailblazer. I'm a beneficiary. So, I've had the privilege of being trained by Dr. Jane Weeks, by Dr. Judy Garber. I, myself, had so many great mentors who were women.

I would say to women, that you can have it all. You just may not be able to have it all at once. Women and men have to make choices. Can you have a lab and be a laboratory investigator? Yes. Can you do that and have a family? Yes.

I think running a high-power lab and having a gigantic clinical practice and running clinical trials, I think the three-legged stool and the so-called triple threat is really, really hard. But I think it's hard for women and men.

What I would also say to women is you don't have to be the boys - be yourself. I think the best advice I can give to leaders is to be authentic. Because everyone, men, women, people smell a phony and no one likes to phony.

So, I think if you know how to partner, you understand that it's a team sport. I think women do that really well. So, I think being authentic, and I think women need to hear that, you don't have to emulate male role models. You have to be yourself.

I would love to emulate the two of you. I have to thank both of you because the Indiana Miracle and Dave from his Vanderbilt days, Vandy, as Dave likes to call it, from his Vanderbilt days to his Texas days, like, the two of you are such incredible thought leaders and inspirational leaders in oncology, but I can't be you.

The best we can be is sort of the best version of ourselves but we can be inspired by the great qualities that we see in other leaders and carry a little bit of that with us. So, I think that goes for women and for men.

Dr. Pat Loehrer: Thank you! Well said, and I appreciate the thoughts. We've kind of gone through this and we're going to have to wrap it up. One of the questions that we often times ask our visitors is if there's a book that they're reading, a documentary that they're watching, a movie they're seeing, or anything you'd recommend?

Dr. Deborah Schrag: That's a good question. So, yes, actually. One of the ways that I learn about leadership that I find, actually a fun way that's both relaxing and educational, is to read a biography. I love reading biographies.

I'm going to name two. And these are popular books - for scholars these may not be. First really fun book is 'The Splendid and the Vile', by Erik Larson. It's a book about Winston Churchill in 1940, and how he has to try to persuade the United States to enter World War Two, but it's really about a particular year in history and Winston Churchill.

Dr. Dave Johnson: It's a great book.

Dr. Deborah Schrag: It's called, The Splendid and the Vile. I just learned so much about leadership from that book and the decisions that Winston Churchill makes in his bathtub. So, just read that book and think about what Winston Churchill does in his bathtub. I can't lead from my bathtub, I live in a New York City apartment, but that's one.

Then more recently, I guess there's a little German theme happening here, is, The Chancellor. It's about the life of Angela Merkel. It's long, I haven't finished it yet. But it's incredible. What a story, East Germany, her leadership style, how she studies chemistry, how she rises. It's a fantastic book. It's called, The Chancellor. So, I will recommend that one.

Then the last one, my beloved nephew who's like a son to me. He's about 36 years old, and he has ALS. And he's completely paralyzed. He is on a vent and he has two little kids. But he released a documentary that actually won at the Tribeca Film Festival called, Not Going Quietly, which is about a cross-country trip that he made. He's a pretty inspirational character, despite the fact that my nephew was completely locked in, he communicates only with his eyes. He is living a remarkable life. I think that documentay, I know this is a shameless plug for my nephew, but he's a pretty inspirational character. I don't necessarily agree with 100% of his policy prescriptions and recommendations. But there are lots of ways to make meaning in the world. So, that's another documentary.

Dr. Pat Loehrer: That's incredible. Thank you so much for sharing that. I'm going to look it up. People think cancer is the worst thing you can get but there are worse diseases to have.

Dr. Deborah Schrag: Yeah, I think this one might change your idea. And then I would also say Paul Farmer's Bending the Arc. I think for young physicians who haven't seen that movie, I would recommend Bending the Arc.

Dr. Pat Loehrer: Thank you.

Dr. Deborah Schrag: Thank you! It's been great to chat with you.

Dr. Pat Loehrer: It's great. So, that's all the time we have for today. And I really want to thank you, Deb, for joining us and for all your insight. It's been wonderful. I also want to thank all our listeners for tuning in to Oncology, Etc. This is an ASCO Education podcast where we'll talk about just about anything and everything, if you've heard. If you have an idea for a topic or guest you'd like to see on the show or a host that you would like not to see on the show, just email us at [email protected]. Thanks again. And Dave, I just have a riddle for you here. How do you make an octopus laugh?

Dr. Dave Johnson: Show him your picture.

Dr. Pat Loehrer: Ten-tickles. That's all we have for today. You guys have a good evening. Take care.

Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the comprehensive education center at education.asco.org.

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Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

In part one of a two-part conversation, Drs. Patrick Loehrer and David Johnson sit down with Dr. Deborah Schrag to discuss her roles as a leader, researcher, oncologist and public health expert. The current Chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York, Dr. Schrag discusses the joy and passion she has found throughout her career, and more.

If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at [email protected].

TRANSCRIPT

Dr. Pat Loehrer: I'm Pat Loehrer. I'm the Director of the Center of Global Oncology and Health Equity at Indiana University.

Dr. David Johnson: Yes. And hello, I'm David Johnson. I'm at UT Southwestern in Dallas, Texas.

Dr. Pat Loehrer: And welcome to another version of Oncology, Etc.

Dr. David Johnson: Yeah, great guest today, before we get started with our guests, though, Pat, what are you reading these days? What can you recommend to me?

Dr. Pat Loehrer: Well, I'm reading Jamie Raskin's book, which is about his son and about the insurrection. It's really a wonderful read so far, particularly I think about the family nature and how much he deeply respected his son who unfortunately committed suicide.

Dr. David Johnson: Right before one of the impeachment trials as I recall, right?

Dr. Pat Loehrer: It was right before the January 6 insurrection.

Dr. David Johnson: Yeah, terrible situation. I have a book I've been meaning to recommend for a while. It's one that I've given to all the chief residents I've worked with over the last several years. And today's guests made me think about this book. It's entitled, Osler: Inspirations from a Great Physician. It's written by Charles Bryan, who's the former Chair of Medicine at the University of South Carolina in Columbia.

Dr. Pat Loehrer: You trained with Osler, didn't you?

Dr. David Johnson: I was a couple of years behind him. He was my senior resident. For anyone who's an Oslerphile, it's a great book to have. But even if you're not, it's got some wonderful lessons to be learned about how to interact with one's colleagues, and a lot of information about leadership, which is why it made me think of today's guest, Dr. Deborah Schrag who we're really excited to welcome to Oncology, Etc.

Dr. Schrag is the Chairman of the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York. She's a highly accomplished healthcare leader, clinician-researcher, and expert in public health and population science.

Deborah received her medical degree from Columbia University and completed her residency in internal medicine at Brigham and Women's. She obtained her medical oncology training at Dana-Farber in Boston and also received an MPH degree from the Harvard School of Public Health.

After a brief stint on the faculty at DFCI and Brigham and Women's, she joined the division of gastrointestinal Oncology at Memorial Sloan Kettering, where she was an associate member and Associate Professor of Public Health and Medicine.

In 2007, I believe it was, she returned to Dana-Farber and Brigham, where she continued her work focused on improving the delivery, quality, and effectiveness of cancer care. While there, she served as chief of the Division of Population Sciences until this past year when she returned to Memorial to chair the Department of Medicine.

I also think she's the first woman to hold this position, but we'll learn about that momentarily. Deb is internationally recognized as a pioneer for her work engaging patients in reporting outcomes as a way to improve care.

She has led pragmatic trials using informatics strategies to optimize patient and clinician wellbeing, efficiency and quality, and equity of care. In short, she's a true superstar, leading the department, the major department, in one of the world's foremost Cancer Institutes.

Deb, welcome to Oncology, Etc. Thank you so much for accepting our invitation. This is a relatively new oncology podcast, but already, we're known for our incisive, deeply penetrating questions. So, I have a question for you to start off. Do you have any carpentry skills?

Dr. Deborah Schrag: Absolutely none whatsoever, Dave. None.

Dr. David Johnson: I'm disappointed. It's my understanding that Schrag is German for cross or a slant and people who build cross-legged tables. So, I was hoping, my house was destroyed recently, and I'm looking for replacement furniture, and I was hoping you might be able to help me.

Dr. Deborah Schrag: I apologize. But I'm not going to be able to help. The name, you're correct, though, David, is a German name. So, my family does hail from Germany and they made malt, which is the major ingredient in beer. I'm not sure where the name comes from. But they ran malt factories and shipped malt all over to all the beer, before there were craft beer distilleries, that's what they did.

Dr. Pat Loehrer: That may come in handy by the end of this podcast, by the way.

Dr. Deborah Schrag: Could be.

Dr. David Johnson: Well, speaking of your family, tell us a little bit about your background and where you were raised, and your family members.

Dr. Deborah Schrag: Sure! I'm glad you asked that because I really have been very influenced by where I grew up. And as I think about it, experiences that go back to first grade got me where I am today.

So, I am from New York City. I grew up in Manhattan in the 1970s. And as you may know, that was a pretty rough time in the history of New York, what's often referred to as the 'bad old days', although it didn't feel that way to me. But I started out attending New York City public schools. And at that time in my neighborhood on the Upper West Side of Manhattan, my first-grade class had about 45 students, and one teacher, there were about five or six of us who spoke English, and everyone else was a recent Puerto Rican immigrant. I pretty much sat in the corner and read to myself.

Now I didn't stay in the public school system for long, but I saw in first grade, how things weren't fair. And I saw and felt my own privilege, acutely. And even as a little kid, I had that sense.

Eventually, my parents transferred me to private school later on. And there were kids in the neighborhood who didn't have the same privileges that I did. But living in New York, you walk around, you're confronted with disparities every day. We still see it today with homelessness on the streets.

At that time, there was a lot of alcoholism and the use of drugs. And they were two blocks north that were safe to walk and two blocks east that were not safe to walk. So, this really stuck with me from a very early age.

As a student in summer jobs, I worked lots of interesting jobs. I started at 14 scooping ice cream at Baskin Robbins, I worked at a famous Deli in New York called Zabar's, selling coffee. Lots of interesting jobs that I worked during holidays and vacation times. But one of my first jobs was working in an organization called the Floating Hospital, which was a big old ferry boat that circumnavigated Manhattan, and it provided a summer camp. And we would take 1800 people on a boat around Manhattan every day. And my job was to do lead testing. And I learned how to stick kids, test them for lead because there were incredible amounts of lead poisoning in New York City in the early 1980s. And then we would work on tracing the kids and these were toddlers, two-year-old, three years old.

There were many families who were living in homeless shelters in New York City in the early 1980s. And that was really the beginning of my interest in public health and inequities. And really the marriage of medicine and public health. That had a deep and long-lasting impression on me and really stayed with me throughout my career. That early experience, I think it propelled me into medicine and to medical school and also to marry medicine and public health.

Dr. Pat Loehrer: Tell me a little bit, Deb, about your parents.

Dr. Deborah Schrag: Sure! My mother was born in the United States. She was a teacher who many years later after having three children went to law school and she became a litigator. And actually, her boss was Rudolph Giuliani.

My father is a child of World War II. He was a child of German Jewish parents who had to flee the Nazis. Probably the most interesting story is that my paternal grandfather was an OB-GYN. So, I am a fifth-generation physician.

My paternal grandfather was an OB-GYN at Charité, which is a very famous Hospital in Berlin. He was the head of OB-GYN there in the 1930s. But he had, I think he was half Jewish, and the Gestapo asked him to leave and he had to leave. He was an expert in version, which is essentially flipping babies and the setting of placenta previa.

He then left for Lebanon, where he was in the French Resistance and had a thriving OB-GYN practice in Beirut, Lebanon, during World War II. And at night, there was a curfew, and he was part of the resistance and passed secrets around from the Russians to the French, so very dramatic.

My father was born in this setting, and arrived as a new immigrant to the United States in the 1940s, where it was very hard to be a child whose parents had a German accent, given the prejudice against Germans at that time, but also went to New York City public schools, had a tremendous opportunity. It's really kind of the classic New York immigrant success story. You know, arrived in the United States with the shirts on their back and managed to work their way to a better life and achieve success and good education through public education for all their offspring.

I will also say that my father had a public health stint. He worked in North Carolina as an alternative to going and serving in the Vietnam War, he was in the Public Health Service. And he worked in North Carolina in the textile mills and worked on a disease called byssinosis, which is also known as the brown lung. It's an occupational health disease that affects textile mill workers.

As a child, I spent many dinners, hearing about byssinosis and brown lung, and black lung. I think at an early age I really came to understand how the world wasn't fair, and how it was instilled in me early on that it was important to work to try to make things better, particularly for people who didn't have privilege.

And I think when you come from an immigrant family, and you realize how much privilege has been bestowed on you, that really leaves an indelible mark. I have to say, as Chair of Medicine at MSK, it is staggering to me the proportion of faculty here at MSK, but also at Dana-Farber, where I worked previously, we have lots and lots of immigrants who've been able to accomplish just amazing things through just motivation and drive and energy and creativity. And so, I'm a big believer in how much immigrants have powered this country.

Dr. Pat Loehrer: Deborah, are your parents still alive?

Dr. Deborah Schrag: My parents are still alive. They're both in their early 80s. And they both still live on the Upper West Side of Manhattan. So, I'm very privileged and fortunate to have living parents.

Dr. Pat Loehrer: I can imagine the pride that they have for you.

Dr. David Johnson: I just want to jump in and let our listeners know that Deb mentioned Charité in Berlin. That's the home of multiple Nobel laureates that all of us would know like Ernst Chain, who was one of the individuals involved in the development of penicillin, but Paul Ehrlich, Robert Koch, Hans Krebs, and for cancer doctors, Otto Warburg, among others. So, it truly is a world-renowned institution.

Dr. Deborah Schrag: Well, my paternal grandfather was famous for this technique called version, which essentially involves putting your stethoscope next to the uterus, figuring out where the placenta was, and then essentially trying to flip the baby without disrupting the placenta or causing any harm, which required incredible skills with a stethoscope because you had to appreciate, I guess, the placental vessels.

I'm not aware that this skill is still in existence, it was an important skill to have in the 1930s. When, if you did a C-section, there was a high probability of endometritis. So, you could save the baby, but you would often lose mom to endometritis. Or you could save mom, but you might not save the baby. So, at that time it was a big deal, but thankfully no longer.

Dr. David Johnson: This is why we call it an Oncology, Etc. Our listeners didn't know that we're gonna get OB information in this particular podcast.

Dr. Deborah Schrag: Or a digression on the history of medicine. I do find that, you know, I am inspired by the generations that came before me. I think it's also true that there are many physicians who are first-generation physicians in their families and some of us are privileged to have lots of healthcare professionals and sort of feel it as a calling.

Dr. David Johnson: I think of you with many, many talents. But one of the things that I think stood out to me is, many years ago, you were in the van, talking about the financial cost of health care. I remember a very influential paper you wrote in the New England Journal, talking about the cost of treating GI cancer, colon cancer in particular. But where did your interest in that particular aspect of health care begin? What was the stimulus there? I mean, obviously you had a lot of stimulus from your family. What else?

Dr. Deborah Schrag: That's really interesting. This is a little bit of a history of oncology. At that time, I was an assistant professor and assistant attending in the GI oncology service, seeing lots of patients with colorectal cancer. And we were working on a clinical trial of a drug called ImClone C225. And that was the name of the protocol. And we were putting patients in that clinical trial. And you know what? This drug was working.

We were getting excited and the drug was moving ahead. We looked at the Phase 1 data and we launched Phase 2. We had meetings with the research protocol nurse and the research assistants, team meetings, and I would say there were about 50 people who were aware between the GI oncologists and the nurses and all the research assistants. You guys know that it takes a village and even though the villages were smaller then and it wasn't a particularly large trial, there are many, many people involved and everyone had the sense that this drug might be working.

Just for context for our younger listeners, this is back in the early aughts, and basically, the drug that we had to treat colorectal cancer was 5-FU in many different formats and Irinotecan. And that was it.

Some people thought mitomycin might work a little bit, but it was so horrible that it really barely worked. But that was what we had in our bag of tricks. So, the fact that we had this ImClone drug that eventually came to be known as Cetuximab, was remarkable.

So, here's what happened. It turned out that this is the drug made by the company ImClone. And there were some shenanigans, some insider trading. And one of the people caught up in insider trading, in addition to some people involved with the company itself was none other than Martha Stewart, sort of the famous homemaker who still publishes magazines to this day. And you may know that she actually did some time in federal prison as a result of insider trading on this drug.

I remember being a junior attending, and all the people involved in the trial and all the cancer professionals, we all knew this was working. But everyone respected the confidentiality of the situation, of the patients, and all the integrity that goes into academic medicine. And I remain inspired by the integrity of all the professionals, the doctors, the residents. These were not affluent people. I can tell you. we were not paying research assistants a whole hunk of money. They investigated every trade made by this company. There were absolutely no shenanigans or improprieties from the hard-working folks who helped bring this drug to market.

So, as this was going on, we had many patients who were not eligible for the trial who were interested in getting the trial. So, of course, we followed as this drug got FDA approved and came to market. You could check me but I believe it was February 2004, it was FDA approved.

It came out with a huge price tag. It was approximately $10,000 per month. I was mad because I was taking care of regular New Yorkers at that point. I had public school teachers, I had patients on Medicare and they couldn't afford the 20% copay. Because $10,000 a month for Cetuximab, if you have a 20% copay and you're New York City, public school cafeteria worker, is not yet eligible for Medicare with a typical plan that a New York City public school system employee would have, that was $2,000 a month. And that did not work for one of my patients who is essentially what we used to call a lunch lady.

I was so mad that I decided to channel that anger into writing what I think is a perspective for the New England Journal called, "The Price Tag on Progress". I wrote that piece. I know that many, many people and many of my esteemed colleagues have continued to work in that area and do research on the economics of drug pricing and there are many, many experts. I didn't stick with that. Not that it's not interesting, and not that it's not important. It's incredibly interesting and important, but I felt that the solution needed to happen in the legislature, state legislature, federal legislature.

I think that this is about social policies, and we need to advocate for appropriate health insurance programs to make it possible for people to get coverage when they have catastrophic illnesses, and we need to think about the entire approach to drug pricing in this country. I still think that's important.

I'm not convinced that what we need is more research on the topic. I think we need more policymaking and laws on the topic. I think we're still dealing with this. I'm sad to say that it's been nearly 20 years since I wrote that perspective. But I think it was motivated by frustration, not being able to get my patient what she needed, and many patients thereafter. And just the incongruity between some people benefiting from insider trading and all the good people who were doing the right thing.

Dr. Pat Loehrer: I just want to throw in one thing if I can. Len Saltz, who's one of your partners, it was a piece of that trial that he presented at ASCO talking about ImClone C225. And ironically, it had a 22.5% response rate. And Len said, it's a bummer that ImClone didn't call it C995.

Dr. Deborah Schrag: You have no idea how often we used to talk about that, joke about that in the clinic. I have another good story about that drug, which I think really illustrates something I believe and I think it's actually something that Osler said but it's also something I have to say I learned from both of you. And it has to do with listening to your patient.

So, I had a patient named Matthew, who was a young man, 34 years old. He walked into my clinic with a diagnosis of diffuse metastatic colorectal cancer with multiple bilateral pulmonary metastases, which came to light when his tennis game was off.

He was, at that time, an early employee of a newly started company called Google. And he was working on advertising algorithms, and Matt got the drug Cetuximab. And unfortunately, he was on it for quite some time. He was on it for about five or six months. But eventually, it was pretty clear that we were coming to the end of the road. And he and his wife planned a vacation. This was part of his end-of-life process planning. It was their fifth wedding anniversary in the Berkshires.

We worked so hard to get Matt to the Berkshires to a beautiful inn, and on Saturday night, my pager goes off, and Matt cannot sit up. He's weak. And he'd been complaining of terrible fatigue for weeks, to me, and I really hadn't quite figured out why Matt was so fatigued.

I mean, I just didn't understand it. And we get into this inn and I get a call from the Berkshire Medical Center, a small community hospital, 'Dr. Schrag, your patient is here. He's so weak and he can't sit up.' 'What's going on?' The ER doctor says, 'Well, he has a Chvostek sign', which is a sign of severe hypocalcemia. 'So, call me back with the calcium.' The calcium is low.

Well, I think those of your listeners who are closer to medical school know that when the calcium is low, you have to check the mag. And Matt's magnesium was 0.2. And he got some magnesium in the Berkshire Medical Center. And all of a sudden, he felt great.

He was able to go on and enjoy the second half of his fifth anniversary weekend at the Berkshire Inn and he came back. And I felt terrible because he'd been complaining to me of fatigue for six weeks and I hadn't checked his magnesium. I was like, 50 bilateral pulmonary metastases on chemotherapy. That's a fatigue explanation. Suffice it to say that we went on to start checking magnesium on everyone getting Cetuximab.

Now mind you, the drug is FDA approved and FDA labeled at this point. So, we started checking magnesium, and we find that it was low. I start getting on the phone and calling my mentors. I called Dr. Bob Mayer, who was the head of my fellowship director and was like a revered mentor to me. 'Hey, Bob, does anyone up there in Boston have low magnesium from Cetuximab?' 'We don't check magnesium.' I said, 'But can you check?'

I started calling around and that's a great example of the community of oncology. We are a community. I just started working the phones and calling friends and saying 'You guys checking magnesium for any of these folks on Cetuximab?' Suffice it to say, we figured out that their EGFR receptors in the ascending loop of Henle - so, again, back to biology and pathophysiology - the drug Cetuximab was blocking reabsorption of magnesium in the kidney, and it was Cetuximab that caused a terrible magnesium wasting. Oral magnesium did not work. You had to give it intravenously, repeatedly. And we helped eliminate fatigue for a bunch of patients.

About six months later, I showed up at ASCO with these little cardboard slides and a little poster back in the corner and put up our little case series, very little. But I'm proud to say that we changed the label of Cetuximab and it's now on the label that it causes hypomagnesemia. It might be one of my more cited papers, paradoxically. But I think it's a principle that really has stuck with me, and I've tried to impart it to all the students and residents and fellows, 'Listen to your patients because - I think it comes from Osler- they're telling you something. We have to pay attention.'

Again, I have never forgotten that. But really listening and trying to figure out how we can use our understanding of pathophysiology and what our patients tell us to ask questions and not just accept dogma and try to figure out what we can do. And you know, I couldn't have figured that out on my own. I happened to find a really smart nephrologist who happened to be able to sort of go to animal models and knew the right studies and the right people to talk to.

Dr. David Johnson: It's one of the reasons why we are a multidisciplinary specialty. And we use the expertise of our colleagues. I think that's such a wonderful example of listening to one's patient and it really profoundly impacted our understanding of how that drug works and renal physiology, actually.

That wraps up part one of our interview with Dr. Deborah Schrag, Chair of Medicine at Memorial Sloan Kettering Cancer Center. We hope you've enjoyed learning about her background and her early career. In part two of our conversation, Dr. Schrag will discuss her programmatic goals at Memorial Sloan Kettering, the importance of mentorship and leadership, and what it means to have joy in the profession of medicine, and, frankly, much more. So, please be sure to join us.

As always, we want to thank you for tuning in to Oncology, Etc. an ASCO educational podcast, where we will talk about just about anything and everything. So, if you have an idea for our topic or a guest, please email us at [email protected].

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