PIONEERS OF HOPE: Doug Oliver's Interview of Senator Bill Frist, Former Senate Majority Leader &

Doug Oliver: On behalf of the Regenerative Outcomes Foundation, Senator Frist, a genuine thank you. This is a real privilege to talk with you. The first time we talked on the telephone, you were on top of a mountain, and you took time on your anniversary to call us...

Senator Bill Frist: Yeah, yeah, absolutely, in the Smokey Mountains on top of a mountain, and got my priorities right; with my wonderful wife, and with the great field of regenerative medicine and where we're going.

Doug Oliver: I want to thank you again. I know that time is a sacrifice, and I definitely appreciate yours. We're here today mostly because the Foundation has started an interview series called Pioneers of Hope, and you're a pioneer of hope who immediately came to mind. Right now we're in celebration mode, reflecting on the first year anniversary of the 21st Century Cures Act. That bill was signed into law last December, in 2016, and it was passed with amazing bipartisan support. I recently attended a few hearings where Dr. Gottlieb and Dr. Collins gave updates on how the bill has been implemented, and I am twice as excited to talk with you now because we’re actually seeing signs of real impact against diseases that I, and so many other people I know, suffer from. Some of them are within a few years of the most effective treatments we've ever conceived.

I wanted to talk with you about that, because many Americans may not know the rest of the story when it comes to Senator Bill Frist - that the legislation supporting access to regenerative medicine treatments, like the one that restored much of my vision, didn't actually begin with the passage of the Cures legislation. It began earlier with a bill developed largely by you, and sponsored by two senators, Susan Collins whom I've also interviewed, and Mark Kirk of Illinois. You were spearheading the initiative. It was called the Regrow Act, and it provided the first scaffold for the regenerative medicine portion that was rolled into the provisions of the 21st Century Cures Act. You were there from the very beginning.

My question is, now - one year later, with the updates from FDA and NIH - how does it feel to know that you had such a meaningful part in the Regrow Act and the regenerative medicine provisions of Cures?

Senator Bill Frist: Well first, you're exactly right. The 21st Century Cures Act, which evolved and took language from the original Regrow Act, demonstrates that bipartisanship is alive and well when it comes to issues surrounding regenerative medicine. [These are] important issues in health care, that we know have been not so much overlooked in the past, as have not received the appropriate emphasis and discipline that they deserve, because of the newness of the field itself, in order to continue great research and accelerate execution and implementation of the findings of that research to the benefit of mankind. The Cures Act demonstrated that we can still find strong bipartisanship in Washington on health.

We are seeing great progress since its passage; FDA Commissioner Scott Gottlieb who you just mentioned you recently talked to, testified before Congress just the other day that the Agency is using its brand-new authority to consider new steps to move drugs and pharmacologic agents through that whole development and approval process much more quickly than in the past. Thus, we have what has been demonstrated in basic science reaching the benefit of millions, eventually, of Americans in a much quicker evidence-based fashion. As part of Cures, the Agency is working on the implementation of new novel trial designs, and in doing so created the Regenerative Medicine Advanced Therapy, or RMAT which is a program, and it's building on recent advances in gene therapy with disease-specific guidance. And over on the NIH side, we have the NIH investigating approaches to expand participation in clinical trials for children, seniors, women, and racial and ethnic minorities, and working to implement what is also in the 21st Century Cures bill, the Cancer Moonshot Initiative. These are just some of the examples that illustrate the promising efforts that have been made to include more patient feedback in drug trials and development.

Doug Oliver: Right.

Senator Bill Frist: So, all of these are examples of progress to date of this relatively new legislation, all of which will accelerate over time.

Doug Oliver: Yes, and one of the things that has impacted me and my own sense of hope is the reality that Cures is so fashioned as to place the patient as a bona fide and strong stakeholder in the process, from the very beginning of the drug development. That's something new, and the patients I've talked to are really pleased about that.

Senator Bill Frist: That's a great point, because this patient feedback, and assimilation of patient needs and experiences, is absolutely critical to have, on an iterative basis, the sort of information that is needed, both to execute the benefits of the legislation but also to modify that over time if necessary. It's the voice of the patient that can have the most dramatic impact, I believe, in the legislation.

Doug Oliver: Yes, I used the metaphor that Cures allowed patients to “get up from the children's table.”

Senator Bill Frist: I love it, I love it.

Doug Oliver: We're just coming out of a holiday season where that tradition is well-known by most of us, and we understand that while it's a benevolent place for children to be, it's also a sequestration of the patient process. I want to thank you for supporting those patient provisions. I was proud to help work on those, and I was so glad to see those pushed through, very meaningful.

Senator Bill Frist: I will say, on the 21st Century Cures Act, just a great piece of legislation, been a promising first year with exciting steps forward. And as you've mentioned, I have such strong partners as Commissioner Gottlieb, and NIH Director, Francis Collins. But this progress will only continue if Congress follows through with adequate funding to fulfill this mission of the 21st Century Cures Act. So we need to continue to establish the narrative and the voice, and have people speak out in support of the law, because it has to be funded completely by those members of Congress, and therefore members of Congress have to continue to hear of the vital importance and significance of the legislation, so that they will put that funding forward.

Doug Oliver: That's right. It's really all oars in the water at this point. That's also what I'm committed to, as part of the leadership of the Foundation - we're just going to stay in the water and push along with everybody else. As you reflect on your accomplishments in the 21st Century Cures Act, hope comes into the picture. It must be satisfying for you to be able to reflect on that. Do you have specific hope for miracles that you might see for patients in the coming year?

Senator Bill Frist: I think the whole issue of hope is absolutely critical, because what starts as dreams gets translated into hope, and that hope gets translated into reality by disciplined approaches, input of the patients and the individuals who can benefit, and by the application of great evidence-based science along this whole continual process. As I think about hope, I think back to my years in heart transplants, where initially, when I first started in that field, heart transplant patients simply weren’t a reality. It was in the laboratory, and it was done on a few patients to experiment with. But then, by disciplined research, by innovation being incorporated, and by feedback from the advocates and the patient community, the whole reality of what was almost science fiction - the fact of transplanting a human heart - became a reality.

Doug Oliver: Right.

Senator Bill Frist: And in the same way, in the field of regenerative medicine, and the field of personalized medicine, my hope is that we could continue to develop the science, develop the evidence-based medicine of the reality of what will work and what won't work, continue to innovate the good feedback in an ongoing way, and then make those dreams become a reality. And with that, we can't set our challenges high enough, because we know that science can lead us in a direction that can create miraculous effects.

Doug Oliver: Yeah, if I can interject, sometimes science needs science. It builds on itself and if you don't allow the innovation to happen incrementally, you miss parts of the discovery that are crucial to moving forward in the two steps ahead.

Senator Bill Frist: Exactly.

Doug Oliver: It has to follow a process. And patients have to be patient, as do everybody else. I get it and I appreciate the way that heart transplant technology evolved in that way. I think that you, having been a former Senate majority leader and a heart surgeon practicing for years, you have a unique perspective and I am so happy to talk with you about that because you have that mix. You've been in practice, you've seen patients in their most vulnerable states, you've seen them turn around with hope and new functioning and you've also had the 30,000-foot view. You've had the big picture where you're thinking not just about the patient on the table only, but you're thinking about millions of people. And you were able to pull that public policy miracle off. And it truly is a miracle when you step up from practice to policy, isn't it?

Senator Bill Frist: Yes. You know as a heart transplant surgeon, I remember when I first started transplanting hearts from a donor to a living patient, it was at the time considered risky, it was initially experimental, it required innovation and it definitely pushed the envelope. There was a point in time when people were skeptical that this type of organ transplant could work, just like some people are skeptical today regarding stem cell treatments like yours. But with a little risk carefully considered in a disciplined way we can reap huge rewards. Instead of transplanting a heart and worrying about donor shortages and organ compatibility, there is a possibility of repairing patients' hearts with their own cells. How exciting that would be to no longer to have to do the heart transplants!

Doug Oliver: Indeed.

Senator Bill Frist: Instead of replacing a knee through surgery, we could inject a patient with stem cells from his or her fat deposits to regenerate cartilage. The possibilities go on and on and on. As we look to the future, these hopes and dreams can become a reality. I've seen it in medicine over the past 40 years that I've been in practice and doing research. There has never been a more exciting time for medical innovation than today.

Doug Oliver: Since being asked to serve as an advocate for what started out as the Regrow Act, which was rolled into Cures, I've been granted access to folks like you, which is new for me. It's been unique, and I get to mix with so many folks from all areas of interest in what has become one of the largest growth industries in healthcare in the US. I've learned so much, especially that it is important to act more as an ambassador sometimes then as an advocate for only one position, if you understand what I mean. Patients can often be advocates but not many of us are used to being ambassadors representing more than one interest. You're a true ambassador. You know how to do it and you've traveled to do it. Can you talk a little bit about the idea of being an ambassador rather than an advocate?

Senator Bill Frist: It's interesting because it takes all sorts to move a cultural change and a behavioral understanding. It takes advocates, and I think - being a United States senator or a majority leader with people coming into my office and making a case because of the need, because of the direction, because of a new initiative - it does take advocates to say, "This is the way to do it. This is what I believe in. This is how I've been affected personally and this is what you need to do in that specific area." But you have to take all of that and you have to move it to really being able to be more of an ambassador - to communicate, to basically say, "This is my experience." Also people are having similar experiences in other fields, and let's look at this larger field, this larger initiative and moving the entire field forward, and then you become a spokesperson, a leader, it becomes more collaborative. It becomes about aligning many of the advocates' individual interests together into a larger, and probably more powerful, narrative and storyline that people can understand.

Senator Bill Frist: So, it takes advocates and it takes ambassadors coming into a policy maker's office. They are both very important, and they have to work hand in hand. The advocacy is narrower, more tailored to an individual as an ambassador, which is much more about a movement moving forward.

Doug Oliver: That was very eloquently said and thank you. That describes how I feel the evolution has occurred for me as well, and it's a privilege to be stepping into that role and I hope that I'm doing it justice. There's a common humanity that Dr. Collins and I talk about a lot and it really resonates with all of us, doesn't it? Including senators even and maybe perhaps yourself. That common humanity serves to motivate us to want the regenerative medicine movement to be realized, we want this to work. I find that almost anybody I speak to, really wants this to work.

Doug Oliver: Can you tell a story about where the spark comes from in your own life that has driven you to accomplish the impact on health policy and, in this case, perhaps one of the most meaningful legislation initiatives?

Senator Bill Frist: Yes, in my own life, the spark to public service in addressing the health, and well-being, and physical, mental and spiritual health of individuals - that commitment to service does come back to a blessing that I had as a young child, which was growing up in a medical family. Dad was a family doctor, and two older brothers were physicians as well. My earliest and fondest memories as a little boy are sitting next to dad on the front seat of his old green Chevrolet as he drove to patients' homes carrying his black doctor's bag... That black doctor's bag propped up between us on the front seat of his old Chevrolet... On a house call, walking into a home and seeing a very ill, obviously suffering woman and the impact that dad had walking into the room, sitting on the edge of the bed, holding her hand, talking to her, listening to her, looking into her eye. The power of touch and seeing the impact on that individual's life, with just that simple move resulting in the room seeming lighter and happier, more optimistic, and a smile coming across her face.

That one incident as a little boy has inspired me for serving others in almost a servant leadership way of choosing first medicine as a surgeon, and then going in to the health aspects of public policies as a United States senator, working in HIV/AIDS globally, and helping participate in legislation that has explained why there are 20 million people alive today, the President Bush's HIV PEPFAR. And even today in working with for-profits and non-profits in establishing companies that address the health and well-being of individuals. All of that comes back to these early childhood experiences of growing up with a dad doing house calls and seeing the impact that health, and health care, and science, and medicine are going to have on an individual and their family.

Doug Oliver: That's really inspiring. Senator Susan Collins has told me how she was just so motivated by research, how that has become her passion. She couldn't quite explain why, but she has always been so interested in it, and you could see her face light up. Even though I can't see yours right now, I bet it has. It's really powerful for patients and others to know that these people that they can’t see, or who they might see on TV every once in a while, who are somewhat mysterious - they have families, they have loved ones, they have their own lives and their own challenges. It really brings it home to hear a story of the spark of your inspiration. Thank you for that. My next question is about regenerative medicine patients specifically. I'm a graduate-level medical social worker and have worked in hospitals alongside a lot of cardiologists. Back when I was doing that more actively, it was standard of care that after a patient presented with an MI or other heart problem, they were treated emergently then often moved to the ICU or CCU and further stabilized and monitored, then they were sent out to the floor. Within a couple of days after that, it was really common for a cardiologist to write an order for a medical social worker consult or other counsellor to visit the patient, because we know from experience and research that mortality rates rise without some type of behavioral intervention to manage a patient's anxiety. It's predictable: depression, and social, even spiritual, changes face the patient as they learn the new normal of adjusting to this event in their lives and the necessary changes coming their way.

My journey as a regenerative medicine patient has been similar. There's a need for some type of specialized counseling to anticipate the adjustments that patients like me face. When a chronic condition that has been accommodated and compensated for in every aspect of life for over 10 years is suddenly turned around by some of these innovative therapies, it can be disruptive. Can you comment initial thoughts on the possible need for behavioral interventions for stem cell patients to help impact and maximize their outcomes?

Senator Bill Frist: Yes. I think you make a great point. In expanding the concept of treatments with regenerative medicine, being a part of a more holistic approach to the patient and to their family. Now, with any serious illness or transformative treatment, for the best possible outcome, one must consider the needs of the whole patient, including the emotional, the mental, and spiritual - not just the physical. I learned this lesson a long time ago in the 1980s at the Vanderbilt University Medical Center, when I opened up a transplant center for the heart and eventually for the lungs and had the referral of hundreds of patients from around the country coming in for a heart transplant. Yet we did not have enough donor hearts at that time, nor do we today, for these people, all of them would die within six months without a heart transplant. I was forced by necessity to set up a care management program for those individuals because I didn't have enough donor hearts to transplant them.

What I found was pretty interesting. By having multi-disciplinary care teams, that managed each of these severely ill patients, the tightly knit teams would be comprised of nurses, social workers, physical therapists, nutritionists, chaplains, ethicists, and doctors who treated the whole patient. Their mental health, their spiritual health, their emotional needs, their physical needs. This, heretofore, had not been done clinically for heart failure patients because no single center had such a high concentration of patients dying from such advanced disease. But to my amazement, this team-based holistic approach, which concentrated on the social determinants of health care, the behavioral components of health, focused on the patient and the family led to a much longer than expected life. People would live longer in a life of much higher quality. A remarkably successful new care model had emerged. This holistic approach has a place in many of today's medical interventions, including certain stem cell treatments. Mental and emotional health should never be discounted, it must be a part of the overall treatment course and journey of the patient and their family.

Doug Oliver: Without that... I have seen friends who have received promising treatments like mine, but their comorbidities weren't properly assessed or dealt with. For instance, in one friend intense anxiety wasn't successfully dealt with or even recognized and she ended up scuttling her outcome. She was not compliant with the instructions going forward, and so she had a negative outcome directly related to her behavior. This is huge. It's huge with opioid addiction, there's a huge behavioral component. That is something that's sparked my interest and I was just wondering if you saw that need.

Senator Bill Frist: Yes. Absolutely. And, again, it comes back to that holistic approach. The need is clearly there for a more integrated holistic approach if you want to achieve the long-term outcomes, if you're goal oriented and say, "We really do want to change the course of this individual's treatment plan and journey" so that the outcome is improved.

Doug Oliver: Do you feel that the idea of specialized counseling for stem cell patients might be something interesting to explore? I know that the California Institute for Regenerative Medicine has an alpha clinic model, and part of their original design of that was to have stem cell counselors. They saw a need for that early on.

Senator Bill Frist: Yeah, I think the stem cell, since it is a relatively new development, still early on in its evolution, in terms of the long course of medical history and successful treatments, requires a body of knowledge, a body of information that is useful to have interpreted by individuals who specialize in it, who have the breadth of experience, the depth of experience to walk individuals and their families through this course. Now, realistically, because it is still a relatively new field that's evolving with science changing, that sort of expertise is not going to be widespread. It will be concentrated in certain centers. That leads people such as myself to be working hard in the field of telemedicine and telehealth and tele-counseling.

Doug Oliver: That is a very interesting point, Dr. Frist.

Senator Bill Frist: It will be very effective with today's technology. And I'm currently very involved and serve on the board of the largest telehealth company in America today, called Tele-doc. Although it's not in that field yet, the fact that we are doing 6,000 consults a day in medicine around in all 50 states, makes me realize the power of being able to use technology today, either video technology, telephonic, or even texting to engage in very sophisticated, but also very personal and very intimate, counseling from afar, so that the best expertise in America is available for somebody who might live 300 miles from the nearest facility.

Doug Oliver: What a great idea. I hadn't even thought of that. I just have a couple more questions. One of them is about registries and I thought I'd plug that one in, because I'm currently involved in a collaborative effort that includes the Regenerative Medicine Foundation and the Bipartisan Policy Center to advance a cell therapy registry. This is a very overt question about registries. As a clinician and a heart transplant surgeon specifically, you've participated at the ground level in both developing and contributing to a number of registries, including a transplant one, and they're often even created with the help of government funding. How do you feel about the same approach to stem cell therapies as they stand in medical and translational practice today in the U.S.? Do you think it would be beneficial to patients if a cell therapy registry were in place?

Senator Bill Frist: I have extensive experience in registries and health service delivery. The United Network for Organ Sharing, or UNOS, grew out of a registry here in Nashville, Tennessee, and it is now the centralized network for the entire country through which distribution of organs and tissues occurs. In addition, the thoracic registry for the lung and heart transplant was one of the first and national registries set up in America for the delivery of healthcare, and I participated actively in both the formation and implementation of both.

The power of registries is the bringing together, accumulation, and assimilation of data that can be shared in an organized, disciplined, and equitable way to the benefit of individuals. The development and use of regenerative cell therapies will continue to increase and accelerate over the next several years. Thus, there is a need to establish a national registry, or therapies and other types of registries to support the research, which is so exciting and evolving so quickly, to rapidly expand the evidence base regarding the effectiveness of treatment, what works and what doesn't. To inform the safety efforts in terms of ongoing feedback because we constantly learn what side effects are occurring from real life experiences, all of which can improve a practice and provide important information… which will inform surveillance efforts, all of which will, on an ongoing basis, improve practice and delivery of therapies and will provide important additional data to inform ongoing patient decision making.

Doug Oliver: In terms of patient decision making, do you think patients should have a level of curated access to a registry?

Senator Bill Frist: It depends on which registry it is and how the registry is constructed, but most current registries today have addressed the issue of appropriate curations with exactly the right wording to use, because the interpretation of raw data can be potentially misused in the public space. So with appropriate curation, most responsible and effective registries today do add for curated access for what's appropriate parts of that registry to the benefit of patients. As you know through our work, and you're involved with the Bipartisan Policy Center, we specifically recommend that Congress establish and fund a national registry for regenerative cell therapies beyond bone marrow and cord blood and I hope we'll get to that enacted in the near future.

Doug Oliver: I'm very excited about that initiative. The momentum is there now, isn't it?

Senator Bill Frist: Yes.

Doug Oliver: I think we're bringing all of the major influencers and evangelists for this effort together and I'm very excited.

Finally, Senator Frist, I just want to tell you I appreciate the trust you've extended to me in this interview. Thank you so much. My own journey has produced experiences that created questions we all would like to have answers to. It's taught me that we know so little about not just the physical and scientific influences on patient outcomes, but, like we mentioned, the familial, social, spiritual, and financial disruptions some of those outcomes can trigger. I want to be able to help patients access the innovation as soon as possible in a safe and effective manner, and also help practitioners understand that the patient's experiences can rule the process, and that any risk that is introduced to their experience can have a really profound impact.

I know that you're in me with this, and on behalf of me and the Regenerative Outcomes Foundation, its Board, Advisors, Research Advisors, and the patients who will benefit from its programs, I would like to thank you for your leadership. You are a strong influence worldwide in regenerative medicine. I would actually call you a hero of regenerative medicine, and I hope to join forces with you again sometime really soon.

I have one last question. What is your most important reflection as you personally look forward to 2018?

Senator Bill Frist: As I look forward to an exciting year where we can continue to grow in the application of evidence-based cures and treatments in the field of regenerative medicine, I think back to the words of Margaret Mead. "Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it's the only thing that ever has." I say that because the 21st Century Cures was a significant first step, but it is just a first step and we have a bunch more work to do. The government will not lead the way on health innovation and regenerative medicine. What will lead the way are the strong patient voices, our scientists, and medical researchers. All of them together will continue to challenge the status quo in medicine and in health so that we will have better treatments and exciting new cures and improved patient access.

Doug Oliver: Well said and my gosh, it's a pleasure to talk to you. I could listen to you for a long time.

Senator Bill Frist: Well, listen we have a lot more to do. Let me know how I can help as we go forward.

Doug Oliver: I certainly will, Senator.

Senator Bill Frist: I love what you're doing and remember those early fateful days where I got you together with Senator Alexander, it was the smartest thing. You reached out to me early on and with that, we're helping hundreds of thousands, and eventually millions of people through your hard work.

Doug Oliver: That impact really has had an impression on me and it's now become a labor of love. You'll be hearing from us soon I'm sure.

Senator Bill Frist: Listen, Doug, thank you so much and we'll stay in touch.

Doug Oliver:Thank you Dr. Frist. We'll see you later.