Transcription:
Clinical Research and Cancer Advocacy

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Dr. John Leonard (Host): Welcome to Weill Cornell’s CancerCast, Conversations About New Developments in Medicine, Cancer Care and Research. I’m your host Dr. John Leonard and today’s topic will be clinical research and cancer advocacy. I’m really happy today to have my friend and colleague Dr. Monica Bertagnolli here as our guest. Monica is the current President of the American Society of Clinical Oncology or ASCO and ASCO is really the world’s leading professional organization for those caring for people with cancer. She also holds numerous leadership roles in a variety of different multi-institutional cancer clinical research consortia including her service as group chair of the Alliance for Clinical Trials in Oncology and the Alliance is a cooperative clinical trails group funded by the National Cancer Institute that really runs many of the practice changing large national trials that change cancer treatments. So, really a very high impact role. Dr. Bertagnolli is also the Richard E. Wilson Professor in the field of surgical oncology at Harvard Medical School and a surgeon at Brigham and Women’s Hospital and Dana Farber Cancer Institutes. So, Monica, thank you so much for joining us today. I know your schedule is crazy with all of your busy roles so, it’s great to have you here.

Monica Bertagnolli, MD (Guest): John, thanks so much for inviting me.

Dr. Leonard: So, I just want to start I mean you have obviously worked in a variety of different roles in cancer research and treatment and it’s always interesting to me to learn and I think for our audience how people end up working in cancer research. So, what – how di you kind of start – get into surgery and to cancer surgery and then various aspects of cancer research and leadership over the course of your career? What have been kind of the big drivers of that?

Dr. Bertagnolli: Well I think like a lot of us who go into academic medicine, I always had the research bug and actually it was a little unexpected that I became a surgeon because when I was in medical school, my favorite subject was immunology and I really thought I was going to go an be a medical – an internal medicine physician and study immunology as my main field and then my very first experience to clinical medicine was my rotation in surgery and as happens to I think quite a number of surgeons from the minute I got into an operating room, I realized that that’s where I belonged. So, I went on to become a surgeon, but I didn’t give up the research bug, did study immunology extensively during my residency and then began research in that field shortly afterward. And then finally, I think a lot of my career at least the research that I did in the early part of it was really inspired by a patient that I took care of when I was a resident who was this wonderful, wonderful gentleman who had familial adenomatous polyposis which is a genetic disease that causes cancers, GI cancers as well as sarcomas and I spent a lot of the early part of my career studying why you could inherit a gene that would cause that mutation. It turns out that patients with FAP largely are taken care of by surgeons because surgery is mostly their way of being treated. But we are also hoping to change that someday and who knows, maybe even an immunotherapy approach one of these days will make surgery obsolete. I think that would be wonderful.

Dr. Leonard: So, you are – one of your roles right now is a we alluded to earlier leading ASCO and I think ASCO for people working in cancer and certainly oncologists of various specialties certainly know a lot about ASCO and ASCO does so many different things to help patients, to help research and clinicians and obviously has in part one of the big contributions is the annual meeting which is I presume the biggest oncology meeting in the world probably where so many breakthroughs get presented. But maybe if you could just take a second and kind of give the audience who may be less familiar with ASCO kind of the sense of what ASCO is from your perspective and the different ways it helps people with cancer or cancer research and advocacy.

Dr. Bertagnolli: Sure. Well ASCO has 45,000 members of which about a third of them are actually outside the United States so, it’s truly an international organization and its members are clinicians who take care of patients with cancer. So, ultimately, the organization exists to help doctors and other clinicians take better care of patients with cancer. One of the things I don’t want to forget to mention because many of the listeners today might be from the lay public or might be patients is that ASCO has a website that’s devoted to communication and education and engagement with patients. It’s called cancer.net so anybody who is interested in information on a really large variety of topics can go to cancer.net and find out. The organization itself though really focuses on as I said, supporting the clinicians who take care of cancer patients and in three main areas of providing that support. First and foremost, education, making sure that all of our doctors, nurse practitioners, physician’s assistants have the very best information that they need and most updated information to take care of their patients. The second is research. We are never going to get where we need to be in terms of combatting this disease without great research and so ASCO as an organization tries to support its members to be able to participate in research. And then finally, although it’s maybe not thought of as much as it should be; a lot of benefit can be achieved by just supporting our doctors to be able to deliver their care of the very highest quality. So, ASCO has a lot of initiatives that go to helping clinicians understand what the appropriate quality care is and understand how – what’s the most efficient and best way to deliver care of the highest quality.

Dr. Leonard: Yeah, it’s really incredible how complicated cancer care and cancer research has gotten and I think I mean you alluded to the number of people, the size of the meeting, the number of presentations and the number of programs that ASCO has to serve and contribute to all these areas is really incredible and I think one of the things that ASCO seems to do is really try to give people some sort of framework and support as you alluded to, to really help people navigate the complexity of cancer that seems to be growing every day. I mean it’s really something that I obviously you and I focus in fairly narrower areas, but how a physician in practice can keep track of everything that they need to know to take care of each patient that comes into their office seems to me to be a great challenge and ASCO is a big part of helping people get the information they need.

Dr. Bertagnolli: Yeah, it’s very interesting. When ASCO first started, early 1960s, it was a small subset of clinicians who decided if we can get further in bringing benefit to our patients if we work together, largely they were surgeons. Because in the field of medical oncology wasn’t born until the late 50s and 60s when chemotherapy became a possibility. So, they were largely surgeons, pathologists and radiation therapists and then at the time that ASCO was born; we added the medical oncologists to the team but over the many decades since then; the team has gotten so incredibly large and diverse. People who routinely not just in research, but really participate in the care of patients now are laboratory medicine specialists, psychologists, and those interested in the psychosocial support for patients, imaging experts, experts in drug development and drug delivery, experts in data science. I could go on and on. You can come up with probably 100 different now categories of expertise that has been pulled into the great richness we have in trying to tackle cancer in whatever way we can.

Dr. Leonard: So, each ASCO president has kind of a theme of their – I guess their presidency and certainly things that they want to highlight and yours is Caring for Every Patient, Learning from Every Patient. And I’m curious to hear about kind of why you picked that or how that sums up your priorities and maybe an example or two of how you think that over your time in leading the organization, which is more than one year I know, how you think ASCO will or what your priorities are for ASCO to try to advance that mission.

Dr. Bertagnolli: Well John you and I have known each other for a long time because we work in a cancer clinical trials group together and a huge amount of knowledge has come to us by a very rigorous science of doing cancer clinical trials. We also have a lot of other ways of gathering information about patients. Registries, and other types of efforts, but the reality is that 97% of patients who are treated with cancer have no information shared on them that is used to develop new treatments. So, three percent of our population participates in clinical trials, the other 97% doesn’t have – we don’t have the ability to learn for them or learn from them efficiently. That’s just wrong. The other thing that’s very wrong about it is that the people we do have information on largely because they are participating in clinical trials tend to be affluent, tend to be located in the big urban centers, tend to be white, tend to have insurance; all of the other absolutely important parts of our population that are left out of knowledge and how can we take the best possible care of people if we don’t understand their – if we don’t have their data? We don’t understand quite directly about them and what happens to them when they get their treatments.

Finally, the biggest inspiration I think of wanting to have – shine a focus on caring for every patient, learning from every patient was something that has happened to me, I’m sure it has happened to you from time to time in clinic; a patient will tell me Dr. Bertagnolli, I really hope there is something about my experience that you can learn or use to help somebody else. And sometimes I have been able to say yes, you are participating in clinical research, you are on a clinical trial; but the majority of the time, I feel like I failed them. Because we really don’t have a way to learn from every single patient. So, I think we can make this a mission and we have some ideas about how we can bring this about. I think it would be an absolute revolution in healthcare if we figured out how to bring this knowledge to bare on making the world better for cancer patients.

Dr. Leonard: So, you and I have talked about this and obviously and we will get to clinical trial more specifically in a couple of minutes, because obviously that’s been also a major focus of your efforts in your career; but how do you guide patients, people read in the news about issues around privacy, they hear about industry influence, all these different things and then we have our clinical trials that have a lot of challenges to enroll because it takes time and effort and extra tests and requirements and so on. I guess how do you tell a patient or how would you encourage patients perhaps that are listening or their families kind of just some advice around how to get through this process, to learn about this process, and at least we don’t need 80% of patients to go on clinical trials; but if we took that three percent and took it to 10%, that would be a huge difference for example. So, what’s kind of your advice to patients that they at least hear about this, what should they do and why should they do it?

Dr. Bertagnolli: Well so, first of all, the formal clinical trials world. I think that really is about – if a patient is going to participate in that, they have – the key to that is to have a physician who is involved in their care, who is involved in clinical trials. Because it’s really only the physician that can sit down with the patient, become a partner with them and decide is being on a clinical trial the best thing for you. We don’t want patients on clinical trials unless actually participating in that is going to be the best thing for them. I think that’s something really important for your listeners to understand and this is what clinical trials are about, offering something that might be a test and it might be a flip of a coin that decides whether the patient gets treatment A or treatment B. But the bottom line of that participation is that that is the very best option for that patient. I will add that, that it’s also one of the reasons that is absolutely essential to making it the best option for the patient is that the patient understands and values being in a clinical trial. So, it’s about the doctor patient relationship and both of them becoming partners to participate in research grounded in the fact that those treatment options provided by that clinical trial are the very best options for that patient. So, that’s really great.

The other part of your question though is how do we bring more people into this? How do we expand our ability to gain information from patients? Well the world is – we are now linked by technology. We have a lot of new tools that are enabling patients to directly get involved in research, maybe even if their doctor is not participating. One of the things that ASCO is working on that I’m very, very excited about as part of my president’s theme is something that is very much in development but is at least for now we are calling it the Patient Data Donor Registry. This idea came to me when I was sitting in the Department of Motor Vehicles and I had to renew my license and I signed up to be an organ donor. And then I realized why can’t we have our patients sign up to be a data donor? So, this is something that ASCO is going to make it possible for all of our patients to do directly; contribute their data which can be incredibly valuable to the organization for use in research.

Finally, you asked me about the very important issue of confidentiality. And how do we make sure that our patients are always come first. That nothing we are ever going to do is going to put our patient at risk or use our relationship with our patients in an unprofessional or unethical way. The first and foremost part of that is that the patient is in charge. The patient decides after they hear the options from their doctor; the patient decides what they want to do. Everything has to be very clearly presented and they have to be in control of what they do, or they don’t want to do. If they don’t want to be identified; they shouldn’t be identified. Finally, I’m actually finding some patients who say I don’t care if you use my name. I’m happy to have my name associated with this. Just do me a favor and make sure that you use my contribution to the best possible way.

Finally, I just want to say, your listeners some of whom might not be physicians or other professionals doing research; one of the absolutely crucial things that happens for any research that is done is that we have something called an institutional review board. So, any time we are going to do any research involving patients; there is an independent board that has no stake in the game whatsoever that reviews that research in very great detail and has to give permission in order for that research to go forward. And that is an absolutely crucial safeguard to make sure that any research that’s done is done in a very ethical way and a way that puts the patient first.

Dr. Leonard: So, I want to pivot a little bit to your – an area that has been a central focus for you for many years but in particular the last several years and that is your role in the National Clinical Trials Network of the National Cancer Institute and specifically leading the Alliance for Clinical Trials in Oncology which we have worked together on for several years, but you have obviously led that group and charted a course and moved it forward in very important ways over the last few years. So, maybe for those who are not familiar with Alliance or the NCTN, can you just give people a sense of the importance of the National Clinical Trials Network and what it does and kind of how it works in brief?

Dr. Bertagnolli: Sure. So, again back in the late 1950s at the beginnings, very beginnings of the new field of medical oncology and chemotherapy; the Congress, spurred on by a philanthropist Mary Lasker, provided funding to the National Cancer Institute to conduct cancer clinical trials of new chemotherapy agents across many different institutions. It was recognized that one hospital, one medical center no matter how large was not going to be able to gather enough patients of every different type to properly study different treatments in a way that gave great assurance that the results were correct. So, the funding began then in the late 50s and that network has grown and grown over the years, but we have had funding from the US National Institutes of Health through the NCI to conduct cancer clinical trials continuously for almost 70 years. The groups have changed a lot over time just like the filed of oncology has changed over time. These publicly funded organizations now look at not only new chemotherapy agents, but how do you properly deliver surgery or radiation therapy, how do you manage the delivery of care in terms of health systems in a way that really improves patient’s chance of having successful treatment?

The other point about this whole publicly funded space is that the research done by the NCTN is not research that can be done by any other way. So, for instance, a huge amount of research, very important research is done by industry; the pharmaceutical industry, developers of new devices, that kind of research is paid for by the industry that’s going to benefit from it financially if the results turn out positive. The NCTN publicly funded research needs to focus on work that otherwise could not be done. So, really good examples are maybe comparing two different drugs that are made by different companies and so wouldn’t necessarily – wouldn’t be studied because the companies wouldn’t be designing a study like that. Or the use of surgery in addition to some other type of treatment. Again, not something that industry funding would achieve.

As you can imagine, the research then that’s done by the NCTN tends to have extremely high impact when it comes to actually changing patient care because it tends to be I think more practical and more informative to the routine day to day care of patients.

Dr. Leonard: So, one of the things you touched on and I think you articulated the clear need for a public resource, a public venue to do kind of certain categories of clinical trials and I agree with you. It’s very, very important. We have heard a lot in the news about the issue of industry and collaboration with industry. How do you balance, how do you see that balance and I’m sure this is something you deal with in your own research, you have dealt with it over the years, you deal with it at ASCO, you deal with it in Alliance and elsewhere and I know that Alliance and others have many very productive collaborations with industry. So, how do you look at kind of the double-edged part of it of making it productive and ethical and high priority and balancing all of that out? What’s the importance of that? How do you navigate that?

Dr. Bertagnolli: So, I can tell you specifically what we do in Alliance. We have an expert scientific development team and of which you are one of the leaders. You are our leader of our lymphoma group. And the mission of those, the charge to those teams are to look at the patients you are treating and design research that is the most important research for those patients with that particular type of cancer. And forget about who is going to pay for it. Forget about where it comes from. Just tell us what is the most important work to be done in the field. Then once we have that list, that wish list of these are the studies that the committee feels are the most important; then what my group does, my office does is ask okay, how are we going to get that research accomplished. And then it is a discussion of is it something that only public funding will allow us to do? If that’s the case, then that’s the direction we go. We try to get it funded through the National Cancer Institute funds. If it’s something that the public sector should be funding because they stand to benefit greatly from the results of the research and frankly using public funds to do something that probably should be the responsibility of the supporting industry is not the best I think use of our public funds. So, if that’s the answer, then we engage with the industry sponsors and bring them to the table to have them support the work.

It is very much a public private partnership. The thing that keeps us the most honest frankly are two things. Number one, the scientific committees develop their research not based on any kind of relationship with companies but based on what they think is absolutely the best for the patients and then number two; the freedom or the – one of the enormous benefits of being publicly funded is we are not beholden to the industry sector to do our research. We have that option and can use that to make sure that what we are doing is to patient advantage, not necessarily certainly not primarily to the advantage of an industry partner. It works out that way in a lot of the time which is there’s nothing wrong with that. We want to see a very healthy and active and productive pharmaceutical industry making lots of new wonderful drugs. We just want to make sure that what we are doing for patients is 100% priority what the patients need.

Dr. Leonard: So, what is - and we have been through times over the last several years where this public enterprise which we think is really, really important has sometimes been under-resourced. What can – what do you think the people that care about this area, patients, how can people advocate for support for the National Clinical Trials Network and other areas to make sure that this venue continues to thrive and to grow and is able to do the things that are needed to advance the key issues in cancer care and research?

Dr. Bertagnolli: Yeah, so, we have been through some rocky times lately. You will remember the sequester when that hit our budget, that hit the government budgets, that hit us incredibly hard. Our research group itself took a 20% reduction in funding at the point when – and it was just so tragic because there was – we are in a time of such great advance in science that our need for clinical trials for more and more to test these exciting new agents is greater than it ever has been. So, a few years back we hit some really, really hard times and the number of patients we were able to put on these publicly funded clinical trials decreased dramatically, from a total throughout the entire United States for the network of about29,000 a year to about 18,000 a year. So, it really a commence reduction in the patients we could actually study along with the budget loss.

Over the last three years, however, thank goodness, the Congress has increased funding to the National Cancer Institute. We saw another funding increase this year. We still haven’t made up for all the ground we lost with those bad years, but at least we are heading to stability now instead of the decline that we had. So, we are very grateful for that. We are just really grateful for the advocacy of our patients and other communities that support cancer research that we have seen these increases over the last couple of years. We very much hope they continue.

Dr. Leonard: So, we are drawing toward the end of our time but I just want to ask you one more question as somebody who has been really leading the cancer care and cancer research area and is spending a lot of time looking forward as to what’s needed and where things are going; maybe just a minute or two on kind of your vision or your expectation, what should patients expect over the next five years or so as far as cancer care changing? Because I think people – everyday there is a new article, something new in the news about this and that and obviously, some of these are real breakthroughs, some of these have a long way to go, but how – what should patients and families look forward to and where are things going in cancer care at kind of a high level? How do you think it’s going to be different in the next few years?

Dr. Bertagnolli: So, we have been very lucky to see over actually the last ten almost fifteen years that the mortality from cancer in the United States has been falling. We are making progress very slowly. We are – it’s not entirely clear why we are making progress. You can’t point to one drug or one new treatment and say yup that’s what did it. But overall, our understanding of tumor biology is translating down the line to decreased deaths from cancer. So, that is just wonderful. Patients are starting to see – cancer is so many different diseases. And they are all different. And they are all treated differently. And they affect human beings very differently. So, it’s kind of hard to be global in saying what’s going to happen. But I think almost any patient with cancer is going to see new studies, new opportunities for treatment that we haven’t had before. Now are all those going to work? We wish, but certainly not. But many of them will. And that’s the way we make success and that’s why we have started to see reductions in morbidity. So, I think the bottom line is it is a very hopeful time, there’s lots of wonderful new research coming for every individual patient. It’s hard to know exactly what it will mean but things are brighter than they ever have been and if we continue the way we are; they will continue to get better every single year.

Dr. Leonard: Well I want to thank you for joining us today. It’s been a great discussion and I want to also thank you not only for your support of our programs at Weill Cornell and things we’ve tried to do over the years, but also just your efforts and support on behalf of patients and the research field and your various roles. I mean when you stop and think and I hope you stop and think about this sometimes when you talk about the number of patients that have gone on Alliance trials as an example over your time being in the range of hundreds of thousands and then you think about the knowledge that came from those hundreds of thousands of patients, it’s really literally millions of people that your work one way or another has touched so it’s really obviously, a great thing and I hope our listeners can appreciate that. So, thank you very much for being here and sharing your thoughts with us today Monica.

Dr. Bertagnolli: Oh, that’s so kind John. Thank you so much and it’s great talking to you and it’s great working with you.

Dr. Leonard: Great. Well, I want to encourage our audience to please go ahead and download, subscribe, rate and review CancerCast. You can find it on Apple podcasts, Google Play Music or online at www.weillcornell.org. We also encourage you to write to us at cancercast@med.cornell.edu with questions, comments or any topics you would like to see us cover more in-depth in the future. That’s all today for CancerCast, Conversations About New Developments in Medicine, Cancer Care and Research. I’m Dr. John Leonard. Thanks for tuning in.

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