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2
Plenary Session

Introduction of the Symposium and of the Director of the National Cancer Institute

Harvey Fineberg, M.D., Ph.D.,

President, Institute of Medicine

Good morning, everyone. It is a great pleasure for me to have this opportunity to welcome all of you to this symposium today. As you know, we are here to consider the ways in which the report Fulfilling the Potential of Cancer Prevention and Early Detection can be moved along to the next step: realization.

At the Institute of Medicine (IOM) and the National Academies more generally, we are very accustomed to the task of producing a report. I have often said to our folks here that when the report is done, the project is really only half complete, because what matters is not what is written on a piece of paper; what matters is what happens in peoples’ lives as a consequence. A report is not done until it has been acted upon, and action is not complete until it has had an effect in the world.

So this gathering of all of you who are so engaged and committed to the task of cancer prevention and early detection is part of that task of completion: the task of moving forward together, beyond words on a page to actions by individuals, in clinical care, by health professionals, by institutions, by government. We will have the opportunity through the course of this day to engage in discussion of ways that we can move forward.

I am also very pleased that this program was sponsored jointly with the American Cancer Society (ACS) which over the years has done so much to enlighten the American public and to draw together resources and attention to the critical problem of cancer prevention. John Seffrin, I want to thank



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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium 2 Plenary Session Introduction of the Symposium and of the Director of the National Cancer Institute Harvey Fineberg, M.D., Ph.D., President, Institute of Medicine Good morning, everyone. It is a great pleasure for me to have this opportunity to welcome all of you to this symposium today. As you know, we are here to consider the ways in which the report Fulfilling the Potential of Cancer Prevention and Early Detection can be moved along to the next step: realization. At the Institute of Medicine (IOM) and the National Academies more generally, we are very accustomed to the task of producing a report. I have often said to our folks here that when the report is done, the project is really only half complete, because what matters is not what is written on a piece of paper; what matters is what happens in peoples’ lives as a consequence. A report is not done until it has been acted upon, and action is not complete until it has had an effect in the world. So this gathering of all of you who are so engaged and committed to the task of cancer prevention and early detection is part of that task of completion: the task of moving forward together, beyond words on a page to actions by individuals, in clinical care, by health professionals, by institutions, by government. We will have the opportunity through the course of this day to engage in discussion of ways that we can move forward. I am also very pleased that this program was sponsored jointly with the American Cancer Society (ACS) which over the years has done so much to enlighten the American public and to draw together resources and attention to the critical problem of cancer prevention. John Seffrin, I want to thank

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium you on behalf of all of us here for your support and sharing in this partnership. There is hardly anyone who is better suited to start us off today than the Director of the National Cancer Institute (NCI), Dr. Andrew von Eschenbach. Dr. von Eschenbach, prior to the time that he was scheduled to become the Director of the National Cancer Institute, was poised to take over at the American Cancer Society as president-elect, so he has been detoured from that duty but, I understand from Dr. Seffrin, not permanently excused. Dr. von Eschenbach is a man whose professional life long has been committed to the very objectives that we are talking about today, and that he has championed in his term as the Director, which he began in the year 2001. It is a great privilege for me to have this opportunity to welcome and to introduce my friend, our Director of the National Cancer Institute, Dr. Andrew von Eschenbach. Cancer Prevention and Early Detection: Key Strategies for Challenge Goal 2015 Andrew von Eschenbach, M.D., Director, National Cancer Institute It is a great honor for me this morning to come as the Director of the National Cancer Institute, and begin with very sincere congratulations to you, to the Institute of Medicine and the National Academies, for the work, effort, and the product you have created with regard to the report on prevention and early detection. I believe this report will serve us well, not only as a road map for the future, but also as a means of bringing us together to walk that journey collaboratively and cooperatively, to be certain that in fact, we achieve all of the outcomes that we know are within our grasp. This morning, I would like to spend the next few minutes with you, talking about that journey into the future, specifically talking to you about a destination that I believe is within view. I will talk about it from the standpoint of a research agenda that can lead us to that end point. I know that John Seffrin and others can talk very eloquently about this from the perspective of a cancer control agenda, but of course, both of these agendas are woven together into a very synergistic and complementary pattern. I would like to begin with a vision for this future destination. I think it was summed up very well at a recent important ceremony in the White House celebrating cancer survivorship, and the fact that we have moved from three million cancer survivors in this country around the time that the National Cancer Act was signed in 1971 to now over 9.6 million cancer survivors alive within the United States today.

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium President Bush noted at the ceremony that for the first time in human history, we can say with certainty that the war on cancer is winnable, and that this nation will not quit until this victory is complete. Obviously, we are very pleased with the commitment to continue on in this effort. But I think what is really interesting and at the heart of the matter is the realization that perhaps today for the first time, we have the ability to recognize with certainty that the ability to conquer cancer is within our grasp. The reason why that is true, in my opinion, or one of the reasons why it is true, is because of the investment that we have made in basic and clinical biomedical research, and because of the kinds of things that have been promoted by organizations like the National Academies. The result is that our 21st century quest to truly understand the fundamental nature of matter and the tremendous revolution that has occurred in biomedical research have now brought us to the point that Andy Grove describes as a very magical moment in time called the “Strategic Inflection”: that time in which, by unraveling the secrets of the cell nucleus, we are creating entirely new paradigms in our ability to deal with diseases like cancer. This strategic inflection in which we are immersed, this ability to now approaching diseases in fundamentally different ways, is in fact being led by the tremendous investment in cancer research. In that regard, the idea of the strategic inflection simply is the realization that with regard to diseases like cancer, for the first time we are really understanding cancer as a disease process, and understanding it at the very fundamental genetic, molecular, and cellular mechanisms. This strategic inflection, this new paradigm, is really creating for us extraordinary opportunities that enable us to begin to approach the burden of disease in fundamentally different ways. Instead of simply seek and destroy, find and kill, we now are opening up an entirely new portfolio in our ability to control cancer, to modulate it, as well as to eliminate it. That has created an opportunity for us. But it is more than an opportunity; it is in fact a responsibility and perhaps even a moral imperative. With the tremendous progress that has been made, with the enormous opportunity within our grasp, we now need to look into the face of cancer and recognize that it doesn’t have to be the way that it has been. We should look to a future in which we can fundamentally change cancer. In this regard, the National Cancer Institute has set a very bold, a very ambitious, and to some a very shocking goal. The goal is that we will eliminate the suffering and death due to cancer, and we will bring that about by 2015. We did not say we will eliminate cancer; we said we would eliminate the suffering and death due to cancer or eliminate the burden of disease. We will bring that about because we are in the midst of the strategic inflection in which we have assembled a significant amount of financial and intellectual capital. It may not be as much as we need for the future, but it is more than has ever been assembled before. In addition to the financial resources and

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium intellectual capital, another important development is that this entire effort is immersed in what has been essentially an explosion in enabling technologies. This has made the rate and the pace of progress exponential and exhilarating. So, in terms of the strategy to eliminate the burden, the outcome, and the suffering and death that results from cancer, we can begin to think about a process of pre-emption. Pre-emption is a strategy that enables us to inhibit or pre-empt the initiation and the progression of cancer on its way to a lethal phenotype. We recognize cancer as a process. Doug Hanahan and Bob Weinberg have talked about the six essential steps associated with the process of cancer. If we now begin to think about the product of our investment in research as giving us an understanding of cancer as a disease process, we begin to see that there are multiple steps within that process that make cancer vulnerable. We can think about it as a process in which even before malignant transformation, there is a stage of the process in which we are susceptible to disease, susceptible because of exposure to things like tobacco, or susceptible just because of aging. There is a period of time in that process of susceptibility, and then a moment where there is actually a malignant transformation, and once that occurs, evolution of that transformation to the point where we actually encounter clinical disease. Then there is a continuation through a very complex series of events which ultimately give rise to the lethal phenotype of cancer, namely, the metastatic phenotype. Only then, at the end of that process, over a period, of time does cancer succeed in taking a person’s life. As we begin to think of this process and the burden over time, we can begin to think now of our ability to capitalize on our understanding of the multiple steps in this disease process. We can begin to think of a series of interventions that we can then apply, that are truly transformational, based on our new knowledge, to affect this disease process, and change its behavior. There are many steps, and these are at least a few of the possible steps that are associated with the evolution of the lethal phenotype of disease. In fact, patients do not generally die as the result of a primary tumor. Patients die due to the fact that we ultimately have a process of metastasis and evolution to a lethal phenotype. All of these steps and processes have been the subject of intense scientific scrutiny in cancer research, but there are also now incredibly rich opportunities for us with regard to interventions. So as we think of this disease process, and as you go about your deliberations, we can begin to consider ways to interfere even in the premalignant phase of this process by preventing the actual transformation. Once that transformation occurs, multiple interventions are possible to detect it early at a time when we can apply effective interventions and strategies that we already have available, along with other strategies to modulate and

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium alter that evolution of pre-malignant disease into the process of clinical disease. Finally, we have a whole portfolio of opportunities to interfere with the evolution of clinical disease to a malignant lethal phenotype of metastasis. So we begin to think about cancer as being preventable, able to be eliminated or modulated, so that patients do not die as a result of cancer. That is at the heart of the pre-emption strategy: a strategy along the same lines we use to modulate diseases like diabetes. The ultimate outcome is to enable people to live with and not die from cancer, to eliminate the suffering and death that occurs as a result of the disease. We will incorporate a comprehensive strategy of prevention, detection, elimination, and treatment of advanced disease and modulation of the disease process. There will not be a single magic bullet. There is no single intervention that will accomplish this. But there can be a significant strategy of integration of these interventions to enable us to bring about the outcome of modulation and elimination of suffering and death. We have chosen to approach this at the National Cancer Institute in the context of a portfolio of investment in three areas: discovery; development; and delivery. This enables us to continue to drive our understanding of these fundamental mechanisms by our investment in fundamental research, but to rapidly translate that knowledge and understanding of cancer as a disease process into the development of interventions for detection, diagnosis, treatment, and prevention of the disease, and then to be certain that we are using our infrastructure to deliver those interventions to all who are in need. We can think about detection, diagnosis, treatment, and prevention as a systems biology approach or an integrated approach, in which we are looking at all the components, those components that are operative in the cancer cell or the tumor, those components that affect the person or the host, and particularly the tumor-host interactions. We can also look at the process of cancer as it relates to the environment or populations and gene-environmental interactions, and it is in all these interactions that we will ultimately achieve our desired outcome. We are launching a number of new initiatives that we will guide and modulate over time to continue to drive towards successfully eliminating the suffering and death due to cancer. This morning I want to spend time touching upon some of the very important issues with regard to prevention, early detection, and elimination. We have a significant investment in our portfolio of cancer prevention, and that investment continues to grow. It is a very balanced portfolio, looking at all the varieties and various elements that will enable us to contribute to the prevention and early detection strategies. As you know, very recently we launched a significant and major investment in early detection of lung cancer with regard to the role of spiral C-T scanning as compared to chest X ray. I point this out for two reasons, one, because of

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium how just one single intervention can have a significant impact on the suffering and death due to disease. With the ability to detect lung cancer earlier than we are currently able to, we will have the opportunity to change a disease that carries with it an 85 percent mortality rate to one that could carry an 87 percent survival rate, just with currently available interventions and strategies. The other reason for pointing this out is the need for collaboration and cooperation. One of the very major successes in this study is that within its first nine months of being launched, it was ahead of its accrual goals. One of the important aspects of the launch of this study was a collaboration with the American Cancer Society to work in the community around the 30 centers that are carrying out this study to promote education, awareness, and recruitment to this study. So, again, it is a collaborative effort to achieve success. We have investments in gene-environmental studies to look at mechanisms of susceptibility, because it is critical for us to understand those interactions that occur, that determine our susceptibility to cancer and the trans-formations that occur, and to segment populations into populations at risk, so that we can strategically apply the most effective and the most appropriate strategies for prevention. We need to continue to pay attention to the important elements related to the person with cancer. You are aware of the tremendous investment that we have made in tobacco cessation. I point out again the important success of the strategy, namely the trans-disciplinary tobacco research centers. These TTRCs, which are truly transdisciplinary in nature, have had a major impact on our understanding of the full complexity of tobacco addiction, on the impact that tobacco has on persons. The other important aspect of that effort is to realize our opportunity to apply the lessons learned from tobacco research to other major challenges, especially the ones we have identified with regard to our need to address the problem of diet. You are going to hear later about the important collaborative and cooperative efforts that we have on the subject of energy balance where we are looking at the interaction of diet and physical activity. You will also hear about the important trans-HHS initiatives that are underway in this regard. Prevention and early detection through screening are exceedingly important. We have a significant number of efforts underway to understand our ability to modulate and prevent disease, not only from the standpoint of behavioral modification but also of chemopreventive strategies. You are aware of the very recent publication around the role of finasteride. Peter Greenwald has been at the forefront of that and will speak to that in more detail. But we have established at least proof of principle that chemoprevention in an area such as prostate cancer is achievable, with a 25 percent reduction in incidence. Many questions need to be answered about the biology of prostate cancer and the impact of a chemoprevention strategy like finasteride, but

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium proof of principle is established that we can reduce the incidence of that malignant process. We also have a variety of other opportunities with the COX-2 inhibitors, and the like, with regard to chemoprevention strategies in diseases where prevention alone could significantly affect suffering and death due to those cancers. And we have opportunities with regard to risk identification and the important role that the human papilloma virus plays, especially in cancer of the cervix. We have an opportunity through the development of cancer vaccines and the cervical cancer vaccine trials that are underway to be able to eliminate disease by a preventative interventional strategy. As I mentioned earlier, we have tremendous opportunities with regard to early detection. I have alluded to the impact the national lung screening trial could have through just one intervention such as a radiological technique. But the opportunity that is opening in biomarkers, particularly with protein profiles, is truly mind-boggling. Our opportunities in genomics and proteomics, in terms of our ability to detect cancer early in its course and predict its biologic behavior, are rapidly unfolding advantages from our proteomics initiative. We have, as you are aware, a number of proteomic early detection strategies underway based on some of the experience of looking at protein profiles. In regard to ovarian cancer, these studies are evolving and continuing to track with 100 percent specificity and complete sensitivity the use of proteomic profiles for the detection of early ovarian cancer. These strategies are being applied to other diseases as well. I have mentioned the importance of collaboration. Collaboration is at the core of the success that will be necessary to achieve the 2015 goal to eliminate the suffering and death due to cancer. One important collaboration I bring to your attention is the very recent interagency agreement and formation of a joint task force that the NCI has established with the Food and Drug Administration. Our goal is to optimize and accelerate our ability to move these interventions rapidly through discovery, development, and delivery and through the approval process, so that they can be applied effectively to patient populations. This is important to the work that you are going to be discussing. As we look at strategies for chemoprevention, as we look at strategies for the development of devices for early detection, and as we look at the opportunity to apply those, one key element in our ability to save lives and eliminate suffering is to be able to move those very quickly to the point where they can be applied to patients. That is at the core of that important collaboration. But there are a host of other partnerships that are critically important as well. Many of you in the room are a part of those interactions and a part of those efforts. To eliminate the suffering and death due to cancer, and to accomplish that by 2015, is a bold pronouncement. But it is achievable based on the accomplishments that people like you are making possible. It is

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium achievable based on the incredible progress that we have made up to now, and based on the unbelievable progress that is within our grasp as we continue on this exponential upward trajectory, in this strategic inflection that will truly change the face of cancer and other diseases as well. It is a privilege for me to be able to share with you a glimpse, and it is only a glimpse, of what we are committed to doing to bring this about, and most important, to reaffirm to you the NCI’s commitment to work collaboratively and cooperatively together with you. Working together, we can bring about the objectives and realize the opportunities to accomplish this goal. View from the ACS: Fulfillment of the Potential of Cancer Prevention John Seffrin, Ph.D., CEO, American Cancer Society It is a privilege for me to be here and to represent the American Cancer Society, the world’s largest voluntary health organization and the largest not-for-profit in America today that receives over 90 percent of its total support from private contributions. I am grateful for this opportunity to share with you our thoughts on the critically important topic that brought us here today, namely, the prestigious Institute of Medicine’s recently released report, Fulfilling the Potential of Cancer Prevention and Early Detection. This report, which provides comprehensive evidence-based recommendations for clear opportunities to dramatically reduce our nation’s cancer burden, is a clarion call to action for all of us and for this great nation to put in place key interventions which will make a difference in lives saved and suffering averted from cancer. The twelve recommendations highlighted in this report underscore what is possible in advancing the fight against this disease. Now it is up to us and others in this room and beyond to put teeth into these recommendations through further research and most importantly, implementation. Contemplate the following statement: If implemented and properly resourced, we simply don’t know anything else that can have a greater impact on this nation’s public health in as favorable a way. Think about that. Let me begin my remarks today by stressing the unmistakable and remarkable opportunity we have to prevent premature death and unnecessary suffering in this nation—not only from cancer, but other diseases, too. Our nation’s leading causes of death are listed in order in Figure 1. I want to pause and have you consider them with me. I suppose there must be 10,000 ways that you can check out of this world. When I was in graduate school, we looked at birth certificates from the turn of the century, when a common

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium Figure 1. The ten leading causes of death in the United States. SOURCE: Mortality Public Use Data Tape 2000, National Cancer Center for Health Statistics, Centers for Disease Control and Prevention, 2002. cause of death was being kicked by a horse. We live in a nation where we have roughly two million deaths per year. Would you believe me if I said that over 90 percent of those deaths were from one of this list often? These ten things, of the 10,000 ways you can check out of this world, really represent the ways in which people in our society die, and most often, they are dying prematurely. The most important thing about this list is that these diseases and health problems are largely preventable. They are certainly far more preventable than they are curable. So, indeed, for today and for the foreseeable future, prevention is the cure. Figure 2 underscores the true root causes of death, and even more dramatically conveys the need for more aggressive national strategies to promote healthy lifestyles. While cancer is certainly a leading cause of death, number two overall, and the leading cause of death during the prime of life, it need not be so. If opportunities to prevent and control cancer were fully seized and realized, millions of lives could be saved. Cancer, the disease Americans most care about and most fear, over time, as we have already heard, could be eliminated as a major public health problem. What is more,

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium Figure 2. Medical perspective of the ten leading causes of death in the United States. SOURCE: McGinnis and Foege, 1993. prevention strategies would also significantly reduce risks of dying prematurely from other diseases, such as heart disease, stroke, chronic obstructive pulmonary disease, and diabetes, along with cancer. So on that list of ten, add those five up, and we are talking about 80 percent of all of the deaths last year. We are beginning to understand that if we focus on the right things, we could have an extraordinary, historically unprecedented impact on this nation’s public health. Where is the evidence? Today, for the first time in our nation’s history, we are witnessing sustained declines in overall adjusted cancer incidence and mortality rates in the United States. The trend is down, respectively, 7.5 and 7.2 percent over the last 10 or so years. This is due in part, of course, to progress in research and improvements in cancer treatment, but mostly due to more effective primary and secondary prevention efforts. That is impressive, although you might say it is not a free fall. But from roughly 1991 to 2000, that represents in the aggregate 200,000 deaths that didn’t occur if the cancer mortality rates had remained the same. Remember, through most of the 20th century, the rates went up every year. But

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium even if they just stayed the same as they were in 1990, we are talking about saving 200,000 lives. Many of those whose lives were saved are in the prime of life—42,000 in the year 2000 alone. With the exception of a spike around 1993 due to the widespread adoption of the PSA test, incidence rate downturns are real, though one might say, relatively modest, and they underscore two important points. First, cancer can in fact be controlled in this century if we do the right things. We have turned the corner on this disease, and while there is a great deal yet to be done, we are no longer simply trying to stem the ever-increasing tide of higher cancer incidence and mortality rates. Second, we have discovered that prevention works. That has always been true in theory, but now we have evidence. Indeed, we now know that some two-thirds or more of all cancers could be prevented if we intervened in the right ways more aggressively and with sufficient resources. The current trends prove the concept and bear witness to the progress that we have already made. Here are just a few examples of the successes we have had in changing lifestyle behaviors to improve health and reduce the impact of cancer. Figure 3 shows the comparison between per capita cigarette consumption in the Figure 3. Trends in tobacco use in the United States during the 1990s. SOURCE: Death rates: US Mortality Public Use Tapes, 1960–1999, US Mortality Volumes, 1930–1959, National Center for health Statistics, Centers for Disease Control and Prevention, 2001. Cigarette consumption: US Department of Agriculture, 1900–1999.

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium actual delivery of proven services as a way of keeping their enrollees healthier. As for coverage, I will touch briefly on UnitedHealth Care’s as a large health insurer, actually the largest health insurer in the country at this point. Insurers like UnitedHealth have a role in trying to ensure that evidence-based medicine is delivered in the rest of medicine that is not represented by integrated delivery systems such as Group Health Cooperative and Kaiser, which are the minority of health care delivery organizations. Our benefit package covers tobacco counseling via office visits. Zyban pharmacotherapy is covered by a pharmacy rider. The evidence that pharmacotherapy is effective in conjunction with an organized program and not in isolation has led us to take this position. Although we offer this coverage as a rider for employers to purchase in addition to their base benefit package, the fact is it has a very low take-up rate—something I will come back to as a structural challenge. Behavior change and counseling via office visits is covered. If there are comprehensive programs, those are covered through office services. But as has been pointed out previously, most of the delivery world doesn’t have the kind of organized approach to the five A’s, to a comprehensive model, to a multi-level model that actually has been shown to be effective. The evidence-based screening services, those represented in the IOM report as meeting a consensus about what ought to be covered, are covered as part of our basic benefit package. A report that is under development through the Partnership for Prevention, funded by the Robert Wood Johnson Foundation, examines an active set of initiatives to try and better understand and encourage the role of employers and their perspectives on the delivery of preventive services (http://www.prevent.org/publications/Preventive_Services_Helping_Employers_Expand_Coverage.pdf) It is important from the private sector’s perspective to outline how that sector, read employers, looks at payment issues. Employers are facing an affordability crisis in health care. In fact, as they think about how to deliver health care benefits or fund health care benefits for their workforce, increasingly they are struggling with tradeoffs in benefit design and benefit structure. They are starting to look more and more at what is essential to providing health insurance, versus what is nice to have. Unfortunately, many preventive services, particularly the ones that relate to behavior change, are viewed as in the nice to have bucket, which are the ones that employers increasingly say they can’t afford; if people want it, they will have to pay for it out-of-pocket, and that is a challenge with increasing employee cost sharing. From the employer perspective, it is not just that health care costs are going up, but that they are going up much faster than worker productivity

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium Figure 18. Per-employee revenue and health care costs. CAGR=compound annual growth rate. SOURCE: Hewitt Health Value Initiative; United States Census; Bureau of Labor Statistics (2002 Productivity estimated based on first 3 Quarters). (see Figure 18). The compound annual growth rate of per-employee revenue, what companies are bringing in, is growing about three percent annually, whereas health care costs are going up about ten percent annually. The response by the employer community has been to pick up some of those costs, but also to have more employee cost sharing. Consequently, employees are seeing more and more of their total take-home compensation eaten up by health care costs, either costs for premium sharing or for out-of-pocket costs associated with services. At this point in 2002, almost half of the annual increase in total worker compensation is being taken up by health spending So employers are stuck in this dilemma. They see this escalating cost of health care, and they ask harder and harder questions. What are they paying for, what is the value equation—and they know about the range of unexplained variations in health care delivery, quality, and safety (see Figure 19), and about emphasizing employee involvement in related decision making as they pick up a larger and larger fraction of the cost and participate in health care financial risk. Delivering information to employees is something that is becoming more and more important so that employee choice of provider is affected appropriately. Turning now to some of the structural challenges in health care that relate to cancer prevention and screening, one of the recommendations was

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium Figure 19. Admission rates for common conditions show five to ten fold variations. that insurers should take the proven effective benefits and mandate them. However, it a truism that insurers deliver and provide services that are paid for by employers. An insurer can’t mandate anything as essential, and this particularly holds true if the leading public payer, Medicare, doesn’t pay for it. This is one of the major barriers to tobacco control, or offering tobacco cessation as a defined benefit. In any case, what are the challenges with mandates, although they seem like an attractive idea? Mandates tend to be rigid, they tend to raise costs, and they are typically not evidence-based. An example is prohibition of “drive-through delivery,” or, in particular, the example of autologous bone marrow transplant that was pushed as a mandate in the absence of evidence—these seemed like attractive approaches, but they had some real problems. A second structural issue is the temporal problem for preventive services. Costs of preventive services are incurred today for benefits that often accrue far in the future. Employers facing an affordability crisis ask why should I incur costs for these services today when I may not have this worker two or three years or five years or ten years down the road. It is a public good, but why should I pay for it? I think that is a serious disincentive to delivery of preventive services. Can we generate some novel ideas to resolve these problems? Would it be possible to structure a better market for preventive services? For example,

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium could Medicare, which is really a giant HMO for everybody over age 65, cover public prevention in the 50 to 65 year age group? The benefits will ultimate accrue to the program; is there some way to model that? That is not a new idea, but I think it is something that could be worth promoting. Another idea might be a prevention “credit bank” to keep track of the delivery of evidence-based preventive services on a population basis and therefore avoid duplication of effort and provide for rational delivery of these services over time. We also know that the evidence for clinical preventive services could be better. There are unexplained variations in care, slow progress on the improvement agenda, and the clinical community unfortunately has little sense of urgency here. The variations that have been documented by the Dart-mouth Group include admission rates for common conditions that vary five to ten fold. That is true across the board; Figure 19 just shows some examples. I should point out that the private sector has a role and, I believe, a key responsibility in promoting evidence-based medicine. UnitedHealth Care takes clinical evidence from the British Medical Journal and distributes it twice a year to over 500,000 physicians and advanced practice nurses. We view it as our responsibility to try and diffuse the evidence that is out there as broadly as possible, not only to physicians directly, but also through workshops, CD-ROMs, PDAs, and through other partners. The private sector can also be a source of innovation based on data and analytics, on consumer information, and consumer decision support. Dr. Straley spoke about getting information directly to the consumer. Figure 20 identifies some of the capabilities of UnitedHealth Care through our consumer portal or myuhc.com. The portal has information, a health risk appraisal, best treatments, benefit information, physician database information, performance profiles, and so on. We view this kind of web-based technology as a major step forward in promoting consumer-directed health care. We also have a whole other company that has 24-hour nurse lines for counseling, behavioral interventions and so on. Another innovation is the use of reminder programs, pioneered by the health insurance industry with leadership from NCQA. I mention these not because you haven’t heard about them, but just to show you some of the scale that insurance companies are capable of—that is, 430,140 reminders for mammography screening sent out last year and 537,913 reminders for cervical cancer screening in the form of attractive and thoughtful Hallmark cards with the result that screening is driven from 50 to 69 percent and from 70 to 78 percent for breast and cervical cancer screening, respectively. The point here is the industry’s ability to send out large numbers of reminders, to

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium Figure 20. UnitedHealth Care’s consumer portal promotes consumer-driven health care. of track performance, and to increasingly customize these programs based on the use of information technology and predictive modeling as an example emphasis on detection, prevention, and appropriate care. As Dr. Freeman commented, navigation is another increasingly important facet of trying to actually execute and get services delivered. Consumers find themselves in a very fragmented, uncoordinated delivery system, and so greater navigation capability is another thing in which we have invested heavily. In the last few minutes, let me talk about what I see as the big issues, problems, and questions and ask the group to think with me about some of these fundamental issues that haven’t had sufficient attention. These generally center around values, choices, and resources. First, why cancer prevention instead of disease or morbidity prevention? In promoting an agenda, why not look at all of health care spending? Fortunately, most of cancer prevention actually is good health improvement, as was noted by the IOM report. Second, what is the role of personal responsibility? What role should be played, especially during an affordability crisis? Some of you may have seen the article in the Wall Street Journal, “Skyrocketing Health Care Costs Pit Worker against Worker. Employees gripe that those with bad habits drive up insurance charges for all.” The more you push a preventive medicine

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium agenda, the more this may raise challenges. Is the forklift driver too fat, for example? Finally, who is responsible for channeling resources from ineffective to effective care? The fundamental problem is simply this: too much money is being spent on things of marginal or no value. So while the challenge has been framed today as getting more resources for cancer prevention, for screening, for early detection, the real challenge, in my opinion, is national reallocation and redirection of resources from things that have little value to things that have proven value. In fact, services for which evidence of benefits is lacking should be excluded from coverage. For example, routine screening of smokers using spiral C-T does not presently meet standards of evidence, even though it, like a number of other technologies, is suggested to the public as a possible preventive test that a person might want to have. As a solution, I propose a national discourse on the realities of health care. Health care is expensive; billions of dollars are wasted on services that have little or no value or are even harmful. There is no consensus on an essential benefit package. If we had one, I believe that preventive services of proven merit would be in it. A dialogue to spread this sort of information would be helpful. Fundamentally, we don’t have a system in place to analyze the sources of waste, redirect resources to more productive uses, and to promote evidence-based medicine as the standard. This kind of a report and this symposium present an opportunity to raise that resource allocation issue, because there is ample evidence from the report itself. For example, resources directed at smoking cessation have potentially greater benefit than further intensification of screening, yet this is not a Medicare benefit; seventy percent of colorectal cancer cases occur in the Medicare population, 14.1 percent screened, no change since 1995. Yet, PSA is covered in the Medicare program, although not recommended by the U.S. Preventive Services Task Force. If the largest public payer doesn’t step up to the plate and drive change like it has in other aspects of organization and financing of care, then it is difficult for the private sector to lead on this front. So, I would hope, and I have a very specific suggestion, that the group think about a codicil to recommendations two, four and seven in the report relating to a national strategy, to coverage, and to federal programs. The codicils should say something to the effect that resources should be redirected away from ineffective care, non-evidence-based care, towards effective evidence-based practices to achieve those aims. I think each one of these sectors has a role in that redirection. The American Cancer Society has a tremendously important role as the lead voluntary organization in this field, to raise the issue not only of advances in research at the basic level, at the translational level, but also to encourage the effective delivery of services to the entire nation, to all of our population, particularly those who are most

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium underserved. The way that will happen in a resource constrained system is to push for resource reallocation. The Institute of Medicine can play a role, as it has in the Crossing the Quality Chasm report report (Committee on Quality of Health Care in America, 2001), in some of the work that is being considered relating to taking up the challenge of an essential benefit package and what might be in it. The public sector clearly has a role in ensuring that evidence-based medicine becomes the standard and proven evidence-based preventive services are in place, and the private sector role is to support innovation, to go to scale, to continue to support evidence-based prevention and screening, and to work with the other sectors to make all this happen. Comments, Questions, and Answers Len Lichtenfeld, M.D., Moderator William Dietz, M.D., Ph.D., CDC: My question comes from a book called Epidemic of Care by Halvorson and Isham (Halvorson and Isham, 2003), which talked about how effectively we have insulated consumers from the cost of their disease care, and how important it is to begin to make that connection. Could the speakers comment on how the various organizations have attempted to do this, because I think it affects both the costs of disease care as well as the accountability for preventive care. Dr. Sandy: This is a very hot topic in the private sector. The trend is for consumers to commit a larger proportion of their resources, greater skin in the game, as they say. One of the challenges is that people do need a far more important educational process about where health spending makes the most sense than I think heretofore has existed. Concomitant with the idea of having more consumer resources in health care has to be far greater education. One of the system challenges I see is that the level of knowledge about health promotion activities tends to be quite limited, even among relatively well educated people. Most people think if you just avoid bad habits, you will stay healthy, as opposed to increasing evidence that you must adopt proactively healthy behavior, such as physical activity, to stay healthy throughout the life span. Dr. Staley: We have seen in our system and in other systems as well, that Medicare patients are now paying out of pocket for their drug costs, and they are not taking the drugs that are recommended. But with education and with provision of the least expensive choice, they will comply. So, our system is trying to provide that help now, because we are seeing that more and more out of pocket costs are being borne by Medicare beneficiaries as well as commercial subscribers, as our employer groups are transferring costs to employees. So we are trying to provide them with the least expensive choice

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium for the most evidence-based intervention. Patients generally choose the least expensive, least invasive, highest evidence-based choice that we can provide them. Dr. Ron Davis, AMA: Dr. Sandy, I just wanted to follow up on your suggestion that we try to redirect resources in health care away from things that don’t work toward things that do. I wonder if you have any thoughts on how we operationalize that. It seems it would be easier to add coverage to things that work that aren’t now covered, like preventive services covered by Medicare, rather than ask Medicare or UnitedHealth Care to retract coverage from things that have been covered for many years and are now found to be ineffective. Dr. Sandy: It is always easier to add, which is why we have such an expensive health care system. Part of the answer, it seems to me, lies with getting the broader public to understand the things that people in this room understand about what works and what doesn’t. My guess is that most of the public would consider restrictions on ineffective care to be a bad thing, whereas most people in this room would think that would be a good thing. The American public is in a very different place relating to tradeoffs and choices, compared to the rest of the world. So, educating the public is one place to start. The second piece I think is more activism in Medicare and other programs in saying not just that something is ineffective but that it shouldn’t be paid for. So, again, that is a role for organizations represented here. Dr. Davis: It seems the greater challenge is dealing with all of the medical services for which there is no, or insufficient, evidence on effectiveness. If you look through the guidelines for clinical preventive services from the U.S. Preventive Services Task Force, over and over again you see there is insufficient evidence to recommend for or against. We have a lot more of that situation, I would think, than we do situations where we have solid evidence of ineffectiveness. Dr. Sandy: That is exactly right. The challenge there is to direct resources towards the research agenda that was outlined in the report. We need much more research devoted to understanding what works and what doesn’t, taking advantage of the clinical information systems that are out there, and in settings such as Group Health and other places, that can actually develop and extend the evidence base as a vital part of the answer. Dr. Peter Greenwald, NCI: Dr. Sandy, do you feel there is enough in the way of authoritative reviews on this topic to give you the leverage to make the change? If so, I’d like to know, if not, would that be a useful topic for the IOM? There are private sector people I would like to contact about how to accomplish that. Dr. Sandy: The more the better, in terms of valid, professionally sound, externally-based reference standards. At UnitedHealth, our guidelines and

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium programs are mostly not designed by us; we reference externally valid evidence-based reference standards. It is not something that an insurance company has come up with, for the very reasons that I think are well understood –that the standing of an insurer in this field is viewed with great suspicion. So the more there can be valid evidence-based standards promulgated by specialty societies, by voluntary associations, by federal agencies, by the Institute of Medicine, by groups that are recognized such as the Cochrane collaboratives, the better it is, the more leverage for the private sector in promoting evidence-based medicine. Dr. Robert Smith, ACS: The statement was made that mandates are rigid, raise costs, and are typically not evidence-based. As there have been more and more mandates, these would seem to be anathema to the health insurance industry in general. But the other point you made is that it is hard for companies to take on preventive costs alone, in other words, to do the patriotic thing when all those around them are not. A very good example of this might be colonoscopy for colorectal cancer screening. It is very expensive up front. You then hand off a screened person to another payer; so this seems to be an area where a mandate might actually improve care for everyone. If all companies have to do it, then it benefits everyone as well. In addition, the remark you made about Medicare is very well taken. Here is an instance where private plans can deliver a healthier individual for Medicare later on, so some cost savings would be extended. Dr. Sandy: The problems with mandates is that they are structural in nature. They tend to be rigid, so they don’t flex with advancing knowledge. When there is new knowledge about a particular procedure or a particular population, because the mandate is written in statute, it becomes very challenging to accommodate. Mandates are also essentially coercive social insurance. We have decided that this procedure, this condition, has special status, so much so that it should be broadly socialized and the incurred costs spread out across the entire privately insured pool. Mandates in aggregate raise aggregate costs, and in an affordability crisis environment when those costs increase, more people lose coverage. Those who lose coverage tend to be disproportionately people of low income and minority. So, my plea to the group is to think about the downstream effects of mandates, because they do sound like a viable way, particularly when there is a consensus, to cover a service such as prevention. But it probably makes more sense to think about broad public programs like the ones that I mentioned, extending prevention coverage by the Medicare program to people in middle age, because the program itself is almost guaranteed to accrue the benefits. Dr. Nancy Lee, CDC: I would be interested in your assessment of the ability to get providers to change their practices to do evidence-based medicine. We have been involved in some qualitative research in the past year,

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium and I am profoundly depressed at the ability of physicians to interface with the U.S. Preventive Services Task Force recommendation to change screening patterns in cervical cancer. Granted, we do need to educate the public about the importance of doing things based on evidence, but the first challenge is to get the providers to buy into doing what we have evidence for. Dr. Straley: I am very distressed as well about how to change practitioner behavior, particularly now when all our practitioners are being asked to do more with less. Staffing has been reduced; the number of physicians has been reduced; they are taking care of larger populations. A year ago, they said we can’t do all that you are asking us to do. Our successful programs are those that were carved out of primary care. Our breast cancer screening program, our tobacco cessation programs were integrated; information was transferred back and forth. But the amount of work that had to be done by the practitioner was minimized. Now, we are hoping that our rules-based information system will prompt our practitioners to do the right thing, but we are starting slowly with a minimum amount of prompts, so that we are not overwhelming them with all the rules. But it is a very slow and incremental program to change behavior, even in our well-managed system. Dr. Lee: The plan recently in cervical cancer was actually to lengthen the interval between Pap smears and to not screen women who had had a hysterectomy. In both cases, physicians dismissed those recommendations. I know those, but I don’t do them. I screen women who have no uterus, and I believe in getting them in every year. In both instances, the recommendations would decrease what they have to do. Dr. Straley: In our system they look at it as a workload issue, so we do screen at a lengthened interval and don’t screen women who have had a hysterectomy. But even with that, they are saying it is still too much, we can’t do it all, because we have got this large load of patients that are coming through the door that we have to take care of on a daily basis. Dr. Sandra Reed: I am a practicing obstetrician-gynecologist, and I have experience with this issue. There is a lot of confusion for practicing physicians. You have a lot of hurdles getting information to them on guidelines. They are being bombarded by information from the American Cancer Society, the guidelines you just discussed, as well as the guidelines from the American College of Obstetrics and Gynecology. So, we do have a lot of information coming to us and have to decipher what is best for our patients. But we also see these patients on an annual basis, at least I do. I have the privilege of having a practice without a lot of patient turnover, so I know my patients well. Even if you are dealing with a guideline that women with hysterectomies don’t need a Pap smear, period, or over a certain age they don’t, you also have to take into account their high risk behavior in the past, because this does give them a risk factor. A lot of times, patients will not go

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Fulfilling the Potential of Cancer Prevention and Early Detection: An American Cancer Society and Institute of Medicine Symposium into that with you. You can ask them about it, and well, yes, maybe I do need a Pap smear. Then you also have to overcome the anecdotal experience of physicians themselves, about having that one hysterectomized patient on whom you didn’t do the Pap smear, who gets a vaginal carcinoma, so you have a lot of factors that you have to overcome as far as educating the physician. Plus, physicians are dinosaurs; we tend to practice what we were taught in residency. Overcoming that and changing behavior is very difficult once you are in private practice.