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Remarks by:

Dick Merritt

Senator Kemp Hannon (New York)

Andrew von Eschenbach, MD
Director,
National Cancer Institute
National Institutes of Health

Question and Answer Session

Dick Merritt:

I'm just curious to see how many in the audience were here last year this spring when we visited the National Institutes of Health. There are a fair number of you, that's terrific. Those of you that were expressed to us at least it was an extremely valuable, educational experience for you. One of the few shortcomings of that visit however was that we were not able to visit with the Director of the National Cancer Institute at that time and so we are making amends this evening by visiting with the "new" Director of the National Cancer Institute and confirming, continuing, reestablishing our relationship in connections with NIH. I won't say anything more about that; I'm going to introduce Senator Kemp Hannon from New York to introduce this evening's speaker.

Senator Kemp Hannon (New York):

Our speaker tonight has great accomplishments and a great wide-ranging mind. So he said he would be very happy to take some questions afterward. Andrew Eschenbach is the twelfth Director of NCI in its 64-year history and he's only 100 days into the job, but he comes superbly well equipped. Educated as a doctor at Georgetown, so in some ways this is a full circle. He spent most of his professional career at the renowned cancer center in Texas, M. D. Anderson, where he started out as head of urology there and went on to direct the department itself. He's been a consulting professor in the Department of Cancer, Biology. He was the founding director of the prostate cancer research program which had 60 scientists and clinicians collaborating on research and then moved on to be the Vice President for Academic Affairs and then was Executive Vice President and Chief Academic Officer for a faculty of almost 1,000 clinical researchers and clinicians, all of which probably as we all know given the low key nature of any academic institution, has well prepared him here for the discussions in Washington.

Just before he got appointed he was President-elect of the American Cancer Society and he was a founding member of the National Dialogue on Cancer. He's also found the time in the middle of all this to do over 200 articles and books and chapters in regard to the whole field. We had a wonderful time last year in terms of expanding our horizons as to what happens at the Institute of Health and this of course being a particular nature to our aging population in regard to cancer I think gives us an opportunity to get a sense of what's happening, a sense to ask some questions and maybe a sense to make some suggestions.

Dr. Andrew von Eschenbach:

Thank you very much for the very warm introduction and I would probably only add one other thing to it and that is in the midst of all that activity, in 1989 I also became a cancer survivor, with melanoma and then two years ago I became a second time survivor with prostate cancer. So I come to this wonderful, incredible opportunity and gift to be the Director of the National Cancer Institute with both a perspective on the importance of research; a very clear and passionate belief and understanding of what we need to do with regard to enhancement and therapy and with a tremendous sense of urgency as to how important it is that we get it done.

One of the things that I learned very early in my career at M.D. Anderson was that, I joke that as a surgeon, a surgical oncologist, I didn't think I was God; I knew I was God. But I very quickly learned that the problem with cancer, no matter how good I thought I was or could be or no matter how hard I worked at it, that it would never be solved by one discipline or one individual. That is was going to require not just the multi-disciplinary approach but an inter-disciplinary approach; that we were going to have to weave together the expertise from a variety of clinical disciplines if we were going to truly change the face of cancer and provide appropriate care.

The other thing I became aware of very quickly is that you cannot solve a problem you don't understand. So research had to be the foundation for any hope for progress in the future. So that idea of collaboration and integration and that idea of needing to discover and learn have been principles that have formed and guided me and they're principles that I love and want to bring to this new role and they are some of the things that I want to share with you tonight. I want to share with you what I believe have been some of the incredible fruits of our research endeavor and what we have learned and discovered about cancer and I most importantly want to talk to you about the importance of collaboration and cooperation, especially as it relates to the integration of things that we may be doing at the federal level and the things that you are working so very hard to accomplish at the state and community level. If I can weave some of that story together, it hopefully will serve as a basis for a lot of interaction and questions and answers, so I'll plan to leave an ample amount of time for that.

I feel a little restricted being behind this podium because I really would prefer to be a little closer to you and also don't have a pointer, so I'm going to kind of do the dance here as my able assistant is going to change the slides and we can begin.

The first thing I just want to remind us all of is the unbelievable burden that cancer places on us as a society. One out of every two men; one out of every three women will learn during their lifetime that they have cancer. Over 1.3 million new cases in this country this year and more than a half million deaths will occur as a result of cancer. An enormous problem for us as a country, but an unbelievable problem as it relates to the world global burden of cancer.

Cancer is a global problem. The difficulty I believe however is the fact that the solution to the problem of cancer is really the destiny and the responsibility of this country because there is no other country in the world that has the resources, the capability and the wonderful talent assembled together to solve the problem as much as we do. And we have been blessed that we are a country that's chosen to make an enormous investment in this particular problem beginning most predominantly with the passage of the National Cancer Act in 1971 and that act was passed and signed by President Nixon with the hope and the expectation that by making a rapid investment we would in fact quickly solve the problem much in the same way we put a man on the moon after the challenge of President Kennedy.

The problem was, as I pointed out and as I learned that about that time when my own career was beginning, is that we did not have the tools to solve the problem. We didn't even understand the problem, let alone be able to eliminate it. But what our national investment in cancer has done is that over the past 30 years we have begun to learn and understand the problem of cancer at the genetic, molecular and cellular level and so now what we are is poised at a transition in a new paradigm. And the new paradigm, the new transition, is to move from the paradigm that I grew up in, which was seek and destroy. Our approach to cancer was to find it and kill it. Find it as early as you can and kill it as dead as you can and our weapons were weapons primarily of destruction, surgery, radiation, chemotherapy, etc.

What we have accomplished in this understanding of the biologic basis and mechanisms of cancer is that we are now poised to change that paradigm from seek and destroy to a paradigm that I describe as target and control. We now have the opportunity to use this information to develop interventions. Interventions that can detect, treat and even prevent the disease and now what we are challenged to do is to take this emerging new knowledge that's coming out of research to take what we're learning through discovery and translate it into these interventions and also make certain that those interventions are being delivered to the patients, to the people who need them the most. So what I see as an opportunity in terms of our collaborative interaction is to look at the total perspective or portfolio from discovery, to translation, to delivery and be assured and responsible for the fact that we're meeting the promise.

To give you just a little brief concept of the science behind this issue of target and control or command and control, moving away from the idea of seek and destroy, is that we recognize now that the process of cancer, the way in which it develops and eventually takes someone's life is really a series of well-defined steps; steps that have to do with how these cells begin to grow in an uncontrolled and in an unregulated fashion. How they begin to invade into the surrounding neighboring tissue and then how they ultimately find access to the blood stream and spread to other parts of the body, or metastasize and then at that point begin to grow in those other areas. And it's not until the metastatic phenotype or the metastatic expression of cancer occurs do we really see the full lethal expression of cancer or its lethal nature.

So if we now understand the genetic, molecular and cellular processes that regulate proliferation that define and determine tumor growth and invasion, and control the process of metastasis, we now have a series of steps in which we can begin to develop interventions. So the idea is to begin to think about cancer much the way you might think about a decathlon champion. For someone to win the decathlon you have to compete successfully at a number of events. For that cancer to win it has to be able to do all of those things. Therefore we can begin to think not about necessarily always having to eradicate it or completely destroy every last cancer cell, but to control it. And we can control it at multiple steps in this process or in this cascade or we may do it in one or more of the steps and we'll tailor it for an individual's particular tumor or particular profile. This opens up enormous new opportunities for us. It is creating for us a whole new portfolio of cancer therapies and interventions. Things that you're hearing about, reading about, with regard to gene therapy, growth factor inhibition. The use of drugs which stop the ability of a tumor to create or cause the body to form new blood vessels, to nurture it and support it and on and on and on. So we have now a whole new set of interventions that were not available to us before that are part of this new paradigm.

What this is requiring is for us to create a new approach to the way in which we deal with cancer. We need to create in this new endeavor what is almost a seamless continuum that you might call from bench to bedside or from discovery to intervention and we recognize the behavior of cancer in the clinic; we take that observation to the laboratory, unravel some of the basic fundamental mechanisms that are associated with that phenomenon, and then take that information in the laboratory of the mechanism, figure out what we might do in the way of a creation of a new drug or an antibody that might interrupt that mechanism; bring that back to the clinic and introduce it into the care of patients and determine and observe its ultimate behavior. That circular process is now what is driving the rapid evolution of new interventions and new treatments.

I want to make just two particular points just with regard to the understanding of metastasis because I think they have important take home messages. The one thing we've learned about this process of metastasis and why is it that cancers that begin in the lung or begin in the prostate and can travel to other parts of the body, is that they cause the body to create new blood vessels which come into the tumor, bring oxygen and food to the tumor, but also provide a pathway for the tumor to be able to escape and get to another part of the body. That process of that blood supply development is called angiogenesis and now that we know that and we understand how that works from a mechanistic standpoint, a number of drugs have been developed to interfere with that process. Thalidomide, the drug that was so horrible with regard to birth defects because it did just that, it blocked the development of blood vessels in the limb, that drug is being used to treat cancer.

Interestingly enough one other condition that affects, I'm told 8 million Americans, is macular degeneration in the eye, which is the abnormal development of blood vessels that leak and hemorrhage. These drugs that were developed for cancer are now being applied to macular degeneration and are having exceptional early results and will be applicable to literally millions of patients. Those drugs could never have been developed just in the context of the eye for macular degeneration. They could have only been developed in cancer where we had models and where we could do the experiments. You can't take someone's eye out to experiment on it but you can take someone's tumor out and do it. So the point, the take home message, is simply to remind all of us that an investment in cancer research is an investment that not only can pay dividends with regard to cancer but can pay dividends with regard to a broad array of chronic degenerative diseases. So what we'll see in the new paradigm of biologic based therapies, is biologic based therapies that are going to impact on things on like diabetes; things like Parkinson's, Alzheimer's and a variety of problems.

The other simple take home message I want to point out to you is the idea of what incredible horizons are still within our grasp. One of the things that clinicians have recognized for decades and decades, one of the things that I knew when I was a medical student in the '60's was that prostate cancer, on this side, preferentially spreads to the bone. Just like breast cancer tends to go or lung cancer rather tends to go to the brain. We have known as clinicians for a long period of time that cancers from certain organs have the specificity to metastasize preferentially to certain other sites. We knew that; we've observed that but we didn't understand how that could happen.

Today's investment in research is now making it apparent to us and this is now well developed and well published, that the way those cancer cells go to specific places, the way a prostate cancer cell preferentially hones to the bones and the axial skeleton, the spine and the pelvis, is the exact same way that when you send me a letter and you drop it in your mailbox, I actually get. And the reason that happens is you put a zip code on the letter and my mailbox has got a zip code on it. Cancer cells have on their surface little proteins that are exactly like zip codes and certain places in the body have addresses on them like little mailboxes and the reason why prostate cancer cells go to the bone in a special place is because there's a zip code and an address. So it's just like mailing a letter to a mailbox.

We now knowing that can take the next step and one of the things that's underway in the laboratory and that requires partnership and collaboration with the pharmaceutical and biotechnology industry is to take that recognition that was made in an academic laboratory, take it to the for-profit industry and develop interventions, drugs, that 1) can erase the zip code, so the cell wanders all over and never can find home and 2) put that zip code on new drugs that are smart bombs that will target and go right to the area where the tumor is and no place else. So we have the opportunity for incredible progress that will not only require the seamless interaction within the lab bench continuum, but also requires collaboration and cooperation beyond the academic research institutes to the pharmaceutical biotechnology production component.

Again though, all of these things are wonderful and they're all fantastic from an intellectual standpoint, but they're useless until we actually get them delivered to patients and we truly have saved the life or prevented death and suffering from cancer. So delivery becomes an extremely important part of this whole process and that's what I'd like to spend this latter part of the talk on but before doing so, just quickly run through a few slides to make the point that we're beginning to see dividends from this investment. We are in fact beginning to make progress against this disease.

In the latter part of the '90's, after the initial commitment in the early '70's, we're now seeing overall cases, new cases of cancer, beginning to stabilize. It actually decreased in some areas but there are some tumors for which there are still increases occurring, particularly for example, lung cancer in women and melanoma overall. So we still have a lot of work to do.

In addition to beginning to see a little downturn in the occurrence of cancer, we are definitely seeing downturns in mortality, or death rates from cancer; 6% overall and a particularly important advantage for death rates in older patients with cancer. And you know that there have been some unique success stories in partly leukemia and testicular cancer.

The problem is that this progress that we've seen has not been uniform and across the board. It is in fact heterogeneous, if you will. There still remain significant problems with regard to our progress among certain populations, for example, minorities and the economically under served. And probably there are multiple reasons for this, many of which are societal in nature, but the point being that there are opportunities there for us to even further improve on these outcomes without the need to develop a new drug or to find a new therapy or new intervention, just to be able to deliver effectively to populations that need what we already have.

One of the ways that we need to do this is again to begin to address this disconnect between the tremendous progress we're making in discovery and our ability to create these interventions and being sure that we're able to deliver them effectively to the populations that need it. So this discovery, delivery continuum really begins to take on an important strategic responsibility. One of the components that has to be added to the research production continuum is the whole area of health policy begins to affect our ability to truly meet the opportunity and the destiny of eliminating cancer.

There are a variety of players that have to come into play with regard to this continuum. The National Cancer Institute is responsible for contributing a significant portion of this continuum but it cannot contribute the entire piece. What I have tried to express is that the National Cancer Institute, regardless of how much of an appropriation we are fortunate enough to receive from the President and from the Congress and they have been both this year extraordinarily supportive, but the final bottom line is no matter how much money, no matter how large the NCI is, we can never do it all, but we do have to be responsible for making sure that all of it gets done. So in addition to continuing to contribute in our own unique mission, what I want to continue to foster is our collaboration and cooperation with the other pieces that are necessary to bring this entire continuum about. Some of those pieces are in fact other components of the federal government, even within the Department of Health and Human Services. We have, and I've been fortunate even in the 100 days that I've been aboard, to be able to continue to foster and develop collaborative relationships with CDC, with the FDA and with other agencies within NIH.

We also need to go outside of the federal component to look for the non-governmental organizations and their key role, both advocacy groups and organizations like the American Cancer Society, that are very effective at being able to disseminate cancer control programs at the community level. One particular element that has emerged based on a vision a few years ago that the problem would require a societal solution to cancer that included many other sectors of society has been the National Dialogue on Cancer. That's an effort that has been fostered now to the point where there are over 180 collaborating partners that come from the scientific community, the medical community, the political, governmental community, the for-profit bio-tech and pharmaceutical community; the not-for profit non-governmental organizations like ACS, American Association Cancer Research and many of the advocacy groups.

Part of the agenda of the National Dialogue on Cancer was to look at the implementation of state cancer plans and that was a program that was initially championed by Governor Tom Ridge. Very quickly in the process, Governor Roy Barnes from Georgia became a collaborating partner in that effort and they have gone about creating the state cancer plan initiative, with partnerships developing with NCI, CDC and the American Cancer Society with regard to the implementation of this agenda and it now is really something that's embedded into your own state health department programs through CDC funding mechanisms.

I want to spend a few minutes talking about this concept of the partnership and of what I hope we may be able to accomplish by making this network more seamless, if you will, so that we can embed discovery and the development of new interventions with the ability to deliver them at the community level.

The leadership as I mentioned initially was spearheaded by Governor Ridge. He has obviously, because of his responsibility to Homeland Security, is not able to actively participate in the leadership, although he continues to be very actively committed to the program and in fact will address the National Dialogue on Cancer meeting which is occurring here in Washington at the end of this month. So he's maintaining his investment.

Governor Barnes has been particularly effective at taking this model and developing it with regard to his own Georgia cancer coalition and the Georgia State Cancer Plan which really does span the entire spectrum where he is creating not only discovery and biotechnology pieces using the academic institutions as a platform, but also working in construct with CDC and the American Cancer Society to create community, especially in rural and under served community distribution processes that will make sure that everyone benefits. Governor John Rowland from Connecticut has now joined Governor Barnes and they co-chair at the national dialogue level.

The other important portion of this of course is to make sure that this is disseminated and the plan is by 2003 to have all 50 states have a fully operational state cancer plan. They are in a variety of levels of development; they are very heterogeneous with regard to their complexion and right now there are 40 states that have an actual cancer plan in place.

What the National Dialogue on Cancer is doing is providing the overarching platform or forum for the ability for these plans to be developed and to be coalesced and what the National Governor's Association is doing is bringing the state health department leaderships together to look for best practices and really begin to understand how these programs can be best implemented so we cover the entire spectrum of the delivery of cancer services.

The CDC has had the primary responsibility for funding and the development of the state cancer plans through these planning grants that have been quite successful, but what the National Cancer Institute and the American Cancer Society have done is to partner with the CDC to create an academy for the development and training of individuals who are going to be involved in the development of the cancer plans.

This is the layout of the cooperative agreements that have been implemented by CDC, both at 2 year and 4 year levels, but there are obviously a number of areas that yet need to be addressed throughout the country.

One of the things that I would look forward to in this construct is to begin to look at how cancer centers that are NCI designated and funded can begin to be woven in to the entire state cancer plan and process. There are many states in which there are not NCI designated cancer centers yet established, but one of the things that I've convened even within the short time of being in place is a task force to look at the comprehensive cancer centers and to look at how we might integrate them more with each other and how we might integrate them more effectively with regard to their communities, especially at the state level. One of the things that we'll be addressing is the expansion of the cancer center program so that we may be able to fill in a lot of those places where there are not yet dots currently present.

So the idea is a collaborative, cooperative effort and I'm spending a fair amount of time describing this to you because as policy makers at the local level you will actively be involved in and participating in many decision making processes with regard to how these programs are in fact integrated at the community level. It is in fact a strategic alliance, if you will, and there are many other partners that need to come into this process, but I think it's important for us to find opportunities where we can work together effectively to really achieve what I think is the full expression of the vision and of the dream.

This country is blessed far greater than any other country in the world but it's blessings and it's opportunities with purpose and the purpose is to use the gifts and to use the opportunities to truly change the world for the better. We have the opportunity to do that in health. We specifically have the opportunity to use cancer as the leading edge, if you will, or the point of the spear to create this new paradigm, to be able to intervene in disease processes, not empirically by trial and error but to do it in a fashion that is designed and developed for the specific biology of expression of the disease in a particular person. By doing that I think not only will we alleviate pain and suffering and save lives but in fact we will create a much more productive, healthier society that will have unbelievable implications for us as far as our even further destiny regarding quality of life and the standard of living. The only way we're going to accomplish this, just as I learned the first few days I was a surgical oncologist, was by doing it together. By integrating and collaborating and cooperating and the NCI looks forward to the opportunity to not only contribute our particular piece of the equation but to work collaboratively and collectively with you, as well as others, to figure out how we're going to make this a dream and something that's realized by everyone, not only in this country but even ultimately in the world.

So it's a great opportunity for me to come and share a little bit of this with you. It's been a very quick 40,000 foot flyover with a lot of detail that's underneath all of this and I'll be happy to answer any questions that you might have regarding this kind of an opportunity or plan or what we're looking forward to or doing with regard to cancer research in general. So thank you very much.

Question and Answer Session:

One of the things that the National Cancer Institute, the American Cancer Society through its divisions and units, and the CDC are doing is to create these training academies. They're working at the state level with the state health departments and through the volunteer process at the American Cancer Society are looking to create the cadre of people who can actually look at the implementation process and they're creating these training academies to bring them together and put them through a developmental process and so they're inoculating into the states these cadres of leadership teams that will help with the implementation of rollout. Now they have to obviously network with all of the needed components including the state health department officials as well as the delivery resources, be they the academic medical centers or community hospitals, etc. So that mechanism is the mechanism that's in place right now to identify who needs to be at the table and to get them to the table and begin the process of discussion of how can an appropriate program that that state wants and is willing to adopt, get developed. As I said the complexion of these state cancer plans varies pretty widely with one state or another. What the National Governor's Conference is hoping to do is each year its plan is to bring the officials together and look at best practices; look at what's working and what's not working and then hopefully disseminate the best practices throughout the rest of the states. So hopefully that will answer your question.

Well I wouldn't disagree with you on the surface of that comment. I think the whole issue of diagnosis, early detection, is a very complex one. There are some diseases and some methods of early detection that are very well demonstrated and well developed and well proven for which there doesn't seem to be much argument as to their utility and validity and that then begins to develop the justification for their reimbursement. There are other interventions for which there still is some debate as to what their utility is and that leaves them in a little bit of limbo as to whether they should or should not be included under routine reimbursable expenses of health care. There are other agencies that have to weigh into this issue and discussion but I think it's a problem that has to bring to the table the community, the academic community that's responsible for providing the proof of utility. The health care provider community that has to be responsible for the delivery and the group whether it's the federal government through Medicare or private insurance or health care plans for ______, etc., etc., but then the decision of paying for it comes in. I think to give you a simple answer as to whether we should pay for colonoscopy or whether it should be PSA's for prostate cancer or spiral CT scan which is the next thing on the horizon for lung cancer, these are all important issues that need to be worked through.

I can't. I'm specifically prohibited.

Well there are some wonderful interesting things that are coming out of the part of the shop that I'm responsible for. One of the problems with colonoscopy is it's not a very friendly procedure, to put it mildly. There is a stool, a fecal stool test, that looks and is able to see the DNA, the abnormal DNA, that's being shed by cancer cells in the colon or abnormal cells in the colon. So we may one day instead of just looking for "blood" in the stool, we may be actually be able to see the abnormal DNA that's associated with cancer and pre-cancerous changes and make the screening test not colonoscopy. Colonoscopy is a great diagnostic test. It's got its issues with regard to being a routine screening test. But a fecal stool specimen could be a wonderful screening test and that's actually on the horizon. So that's one thing for that particular area.

The other thing, I just want to point out while you're on it. One other very important breakthrough recently that's come out of NCI in partnership with FDA and with a private bio-tech company is in ovarian cancer, where normally we can't find that disease until it's very advanced by virtue of one blood test and the idea was that instead of looking for one particular marker, maybe there would be a profile of proteins, kind of a constellation of things, and using super computing technologies in a variety of things, a profile of proteins has been identified and that has been able to allow the diagnosis of ovarian cancer at stage 1, much earlier in the course of the disease when it's much more curable. So blood tests, stool specimens; for breast, we're looking at aspirations from the nipple that can detect cancer. So there are a variety of things on the horizon.

We have to do the very best today with what we have available to us today and what we have available to us today is mammography. I hadn't even figured out where the men's room was yet when I arrived and this mammography controversy was on my desk. I assembled an internal and external group and we quickly assessed where we were. The controversy began because of a group of people in Europe that looked at the data and were concerned about certain parts of the data, certain studies they did not think were valid so they threw them out and then with what was left over they didn't believe there was conclusive evidence that mammography was saving lives. But there was nothing new; it was a reassessment of the old and there was nothing in their assessment that said that it wasn't saving lives, it's just that they thought that they evidence wasn't as strong as originally believed.

We've looked at it, the preventative health services task force has looked at it and there's no question that mammography finds disease earlier at a time when there was many more options for women; at a time when our treatments are far more successful and there's also no question there's been a dramatic downturn in mortality rates from breast cancer since the introduction of mammography. The outcome, the improved survival is not just due to mammography, it's due to improved therapy and a variety of things. But the bottom line is today, the NCI, I testified before the Senate with the fact that for today we continue to recommend mammography beginning at age 40 and until tomorrow when we do better, with better diagnostic tests and other strategies, it's the best we have today and we need to continue to use it today.

One of the things that's inherent in this new paradigm that I didn't have time to really get into is that our old paradigm thought about the solution to cancer as a cure and that we would do something and it would be gone. And we tended to think in terms of looking for the silver bullet. In the new paradigm it's not going to be a silver bullet; there's not going to be one treatment. There's going to be a portfolio of treatments tailored for a particular situation and we're not necessarily always going to completely eradicate cancer but we're going to control it. And cancer will be thought of more as a chronic disease than an acute disease. We tend to think about it like infections. Acute disease; get pneumonia, take your penicillin and it's over. Cancer is not going to be like that. Cancer is going to be like high blood pressure or high cholesterol or even diabetes. You control it; if you can control your blood pressure and your cholesterol and you live your entire life and die of old age without ever having a stroke or a heart attack, that's a victory. So prostate cancer interestingly enough has been nature's experiment or model for that. There are many men who actually have prostate cancer who live their entire lives with it and die "with it" rather than "from it" and in that case the fact that they had prostate cancer is really not the issue, whereas other men develop prostate cancer and it's the second leading cause of death. So what we'll see in this crystal ball is our ability to not necessarily completely cure or eradicate but control and suppress and allow someone to live a full rich life and die of some other reason.

I think we'll see incremental successes in that. Parts of the tumor problem will yield pretty quickly to those kinds of interventions. Glevec for example has been a very important advance in things like leukemia. Some other tumors will probably be more refractory but, if you ask me to speculate, what I would be willing to bet on, I would say that within the next 10 - 15 years we'll see this disease come to a point where we control it rather than it kills us.

There aren't really any available interventions or strategies that really reliably do that. There's a lot of evidence to suggest that if you are early on in the process or you are very limited in the amount of disease that you're coping with, there are benefits to things like a diet that's low in fat and the addition of things like selenium, Vitamin E, etc. So there are emerging kinds of preventative interventions; but there isn't anything that is able to do the more, if you will, grandiose kind of goal that I set out which is to reverse the process. This is where an enormous amount of research is being focused in terms of looking at the biology of prostate cancer and trying to understand what the difference is between those invalent tumors that never kill v the ones that tend to be aggressive and if we understand the difference can we then use that information to convert the bad ones to the good ones. And there are a lot of things that are emerging in that regard. There are certain genes that are being recognized that are a part of that story and there are strategies that are being developed to alter or change those genes. But it hasn't reached the point yet where we have a strategy that we know we can reliably reproduce and apply and solve the problem, but there's a lot of exciting work being done and I don't think we're that far away.

My statistics are much better than that, when you're talking about full colonoscoopy, the entire colon; much, much better.

(inaudible response)

Yes, at least for active lesions.

It appears that pancreatic cancer has increased but it's not certain whether it's actually increased because of its biology or whether it's just detecting more in cases, picking them up. I think one of the things, reading my mail, e-mail or something, but one of the things that talked about just today, as a matter of fact, is the ability to do much better epidemiologic studies around pancreatic cancer, so we really do start to get a handle on what the true incidence of it is and if it is in fact becoming epidemic, like melanoma tended to be. The other part of pancreatic cancer is that we just detect it so late and we have to find more effective earlier methods of detection of pancreatic cancer. It's understanding the disease and being able to detect it earlier and pancreatic cancer is actually a very important agenda for us and we've got a 10-point program that's underway with pancreatic cancer. It's a killer that is just devastating.

I'm not answering the question because I'm not trying to be glib about lobbying; that's not the point. I'm really just struggling with whether I'm smart enough to give you a really good answer to your important question. One of the things that troubles me personally the most and where I think maybe state cancer plans can have their greatest impact is this tremendous disparity in our ability to deliver what we already have, what we already know. It's disparity in that we're not reaching out to communities and providing detection strategies that are already available to us, like mammography or pap smears, and more to the point once we do that we're not linking those detection programs with the availability or access to treatment, so patients who have an abnormality actually can get something done about it. So at the state level I think you are to depend upon us to be continuing to drive the discovery piece to get more tools, to get a test that's better than colonoscopy and more easily applied, etc., etc., while you work very hard in making sure that we can get that out into the community. I think you face the same challenge that I do in that you can't do it all. You have to get other components of the society within your state to partner up and I think health care delivery systems; local, regional hospitals and chains and non-governmental organizations, like the American Cancer Society have to get into that process and help with that as do your state medical societies, etc. So if I were a policy maker at the state level, I think what I'd be focusing on was to be certain that we're putting in place policies that were assured that we were delivering what we already had available.

Let me answer the first part of the question. The idea of complementary, alternative medicine, the idea of being open to strategies that are not mainstream to Western medicine; one of the things that's very apparent to me in understanding the problem of cancer is that we have done a great job of being able to study the tumor and the cancer cell and we are unraveling a tremendous amount of information about those mechanisms. But that tumor, that cancer cell, doesn't live in a vacuum; it lives in a person and the outcome of that tumor is very much depending upon the interaction of the tumor and its environment; both it's micro-environment in terms of the cells that are immediately adjacent to it, as well as what I call the macro-environment, the overall environment, whether it's immune status or hormonal status, etc. So the interesting thing for me in that process is that the person is as important as the tumor and we haven't paid as much attention to the person, to the host, as we need to.

The difference between Western medicine and Eastern medicine, the Eastern medicine has paid a great deal of attention to the host, to the person, thinks in terms more holistically and thinks in terms of mobilizing the person to fight the tumor and I think we have to be open minded about that. I think there is much to learn and much that we don't understand. So my perspective is to be very open and I have some interesting theories about some of that but at the same time apply scientific rigor so that we keep it out of the mumbo-jumbo kind of stuff. But to be open and to be sensitive and aware that there's much to be learned but to do it in a very prescribed, scientific way so that we really have knowledge and not just information.

There are a subset of patients in whom there is a very definite familial hereditary component and those are patients for which a lot of the genetic defects are being identified that contribute to that and in a family that has that kind of predisposition that's clearly the kind of family in which early surveillance with colonoscopy and looking for polyps, etc. becomes extremely important. The fact that there's that cluster is a very important indication for the need for early detection strategies for that family.

Yes, very much so. There are a whole lot of components to that story. One of the things we're paying a great deal of attention to is what I would describe as gene environmental interactions. Everybody knows somebody who smokes, 30 years, 2 packs a day and never got lung cancer and that's because this idea of gene environmental interaction is really at the heart of many of the problems that we see develop. In your body you have genes that; well, we're always being assaulted. I mean there's always something happening to our machinery in ourselves but we have genes that are responsible for repairing those defects. So when you smoke or you go out in the sunlight or you get exposed to something that's bad for us that may cause a problem, a damage to the DNA, but we fix it, we repair it and nothing happens. Some people are more susceptible to cancer because they're repair mechanisms are not very good. Those genes are not working very well. Some people get cancer because they have genes that are defective that result in the actual cancer. So genes are very important but they're important in lots of different ways and then what happens to us as far as the environment, what we're exposed to, also is important in playing a roll. So our research is looking at genes in a variety of different ways but it's also looking at environment and how the environment affects the genes in a variety of ways. So it isn't a simple solution but it's the complex interaction. But there are families in which there is a gene that's defective and that gene can get passed on from generation to generation that make them more susceptible to cancer; not that they're going to get it but that their susceptible to it so if they get exposed to something then the cancer is likely to occur.

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