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As prepared for delivery to the annual meeting of the
American Association for Cancer Research
Sunday, April 2, 2006
Washington Convention Center
Washington, D.C.
As I was sitting here this morning thinking about this gathering of colleagues - and perhaps because it is a Sunday morning - I am reminded of a story I heard a number of years ago regarding a very prominent theologian. He was attending a national convention of his denomination in New York City and was assigned to deliver the Sunday morning sermon for his fellow preachers. Ascending the marble steps to an ornate pulpit, he paused for a minute to gaze out over his august audience, and then said: "What I have to say to such a learned group of colleagues this morning is not necessarily new. But all of you need to hear the message anyway." So this morning, even if my message is not necessarily new, I hope you will listen. I hope you will hear a message of responsibility, a message of unprecedented opportunity, a message of hope.
Thank you, Peter, for your kind words of introduction. Peter and I go back a few years, having worked together on several NCI committees. Peter was also a valued external advisor for the Cancer Center at the University of Wisconsin during my time as director. I would also like to pass along my congratulations to Geoffrey Wahl, incoming President of our organization. Geoffrey and I had the chance to sit in his office a week ago and talk a bit about the future of AACR and of NCI. My sincere appreciation to my very special friend and long-time supporter, Marge Foti, for this special invitation to appear before you this morning.
Many of you are special friends and many more are valued colleagues: relationships that result from over thirty years as a researcher and cancer physician. For me, the opportunity to speak to you this morning - representing your National Cancer Institute - is, indeed, a cherished honor. You and I know that, as members of AACR, we have an important role to play in ensuring the success of the NCI. As members of AACR, we also know all too well the face of this disease. We know all too well the pressure to change its outcome. So I come this morning not to deliver a speech, but to begin - I hope - a dialogue.
As I stand before you, I am well aware of the many questions and uncertainties on your minds: questions about leadership at the National Cancer Institute; about the challenges of managing a deficit budget; about "big science" vs. R01s; about training the next generation of scientists; and about important questions regarding the NCI's vision and strategies needed to achieve our goals. Without question, these are challenges that lack easy answers. Yet I firmly believe that - for the NCI and for all of us, as members of AACR - wisely negotiating uncertain times is the essence of leadership. As Winston Churchill said: "Difficulties mastered are opportunities won."
Looking at the agenda of this meeting and seeing the number of people attending, it is clear to me that there is a sense of unprecedented scientific opportunity and a real sense of mission. Hearing the talks this morning offered an insight into the tremendous opportunities at hand.
Across my career, I recognize the many intersections of missions and opportunities. At Michigan, for example, where I began my academic career, I was given the unusual opportunity to work not only as a cancer surgeon in the Department of Surgery, but also to have a full appointment in the Department of Microbiology and Immunology. Each day, I was able to witness how the lab and the bedside were - and are - intertwined.
I also remember, in the early days of the lab, purchasing the first desktop computer for our lab at Michigan. Who would have thought, at the time, that I could, today, do more - faster - on a little BlackBerry I carry on my belt? In the 1970s, at a time when we were ecstatic at the ability to make monoclonal antibodies to mouse histocompatability antigens, who would have thought that we could successfully map and sequence 100 percent of the human genome?
Here we are, ready to accept the fact that we will be able to identify - for each of our patients - all their cancer-related genetic aberrations. We are truly entering a new age of discovery and a new age of therapy: an age in which we will be able to specifically tailor our prevention and our treatment for each individual patient. Ladies and gentlemen, this new treatment isn't decades away. The technology exists today. It exists because of our country's investment in cancer research and because of the work in your laboratories.
In speaking with you this morning I would like to focus on three issues. First, let's talk for a moment about leadership at NCI. In doing so, I want to stress that, in this time of transition, the leadership of NCI is solid and steady. Second, this morning I would like you to understand that the budgetary situations we face, while severe in nature, are cycles, and we have seen them before. Third, I hope we can remind each other that, whatever the bumps in the budget road, whatever challenges, we have an extremely important job to do and vital opportunities to grasp.
I would be remiss if, in addressing the first point concerning NCI's leadership, I failed to express my gratitude and extend the appreciation of all of NCI to Andy von Eschenbach for the last four years of his service. His tireless dedication to the institute, to cancer patients and cancer survivors, is truly inspirational. In Andy, NCI has had a superb director, and the cancer community has had an extraordinary ambassador full of vision and full of passion. Andy has boldly set, for all of us, the challenge of alleviating the suffering and death due to this disease.
I - like many of you - have been coming to Bethesda, it sometimes seems, almost monthly for more than twenty years, serving on study sections, ad hoc review committees, and most recently, for almost four years as chair of the National Cancer Advisory Board.
Last spring when I decided to accept Andy's offer to come to the NCI, I did so with a couple of personal goals in mind: First, I wanted to work with NCI leadership to strengthen the clinical research program at the brand new, spectacular Mark O. Hatfield Clinical Research Center. I wanted to work with Bob Wiltrout and Lee Helman, to continue to strengthen the intramural scientific program. Many of you here this morning consider yourselves graduates of the NCI. Today, there are over 1,200 fellows in training at NCI
Because of a personal experience with my wife and breast cancer, I became aware of just how difficult it can be for our cancer patients to get access to early-phase therapies. I promised her I would do something about this.
Much to my surprise, late in the afternoon of Friday, September 23, Andy informed me that the night before, the President had asked him to become acting FDA commissioner - a position for which, as I know you are aware, he is now the nominee. In the weeks that followed, I began to assume the operational control of the NCI. The appropriate formal delegations of authorities were put in place, and have been so, since last October.
While Andy's appointment to the FDA was a surprise for all of us, I firmly believe - as I have told Andy many times - that we in the cancer community are extremely fortunate. To achieve our goals not only depends on scientific accomplishment, but also - and perhaps even more importantly - on critical changes in regulatory policy. We cannot help but benefit from having an FDA commissioner sitting at the Department of Health and Human Services, who thoroughly understands cancer - and who, with a passion unmatched by anyone, believes that science will provide the answers to tough questions of policy.
I believe, if you talk with the Division heads and center directors at NCI, and with the other Institute directors at NIH, they will tell you that the transition at NCI has been smooth and seamless - thanks to Andy's counsel, but especially thanks to the dedication of Deputy Directors Alan Rabson, Anna Barker, and Mark Clanton; and the strong sense of mission that infuses the whole institute. And whether I - or someone else - ultimately serve as its Director, NCI's management will remain unified, solid, and focused on its goals.
NCI has built an astounding infrastructure uniquely connected to a national program of outstanding cancer centers. Every day the NCI and its network of investigators is accomplishing things undreamed of 30 years ago. It is a scientific enterprise that traditionally has led discovery; an enterprise comfortable with leading the development of new technologies; and an Institute prominent in leading translation through its Centers, Co-operative groups and community-based CCOPS.
Anyone who knows the NCI is well aware of its long list of accomplishments. As we turn, then, to our second item of concern this morning, we face one simple question: How does NCI find the resources needed to maintain its momentum?
The first answer is pretty obvious: We must simply become leaner and better at what we do. We must redeploy effectively the resources we have been given. While we might argue that we could use more - and certainly we could - $4.8 billion dollars is a considerable amount of money, by any measure.
The second point of attack is to markedly increase the leveraging of the resources we have through partnerships - with the private sector, with venture investors, with other government agencies and by philanthropy. It is a time for innovation on all fronts.
Third, we must do a much better job of explaining the story of scientific opportunity before us, and I challenge you to do this with a much more unified voice. We must remind the country's leadership of the power of the genetic revolution and the global economic force it will become. Economic studies demonstrate that for every NIH dollar that enters a community, the average U.S.-wide direct return to the economy is $2.45. In some states that multiplier effect may be as high as 13-to-1.
"All well and good," you say, "How about the R01 I just slaved over the past months? What chances do I have? How am I going to maintain my career?" When asked these questions, I am prone to remind my questioner that this isn't a new phenomenon. This isn't the first time the NIH and the NCI have faced a shrinking budget.
Some of you may well recall that the early 1980s were not kind to NCI and to its investigators. That was also an era of rescissions in the federal budgeting process. The years 1981 and 1982 both saw a reduced NCI budget from the previous year. I vividly recall single-digit paylines as I struggled to maintain my own laboratory. I can tell you there wasn't a foundation in the country and a few outside the country that escaped a grant application from my lab.
The early 1990s were similar, if you recall. Budget growth was less than one percent in 1993. So, while the current situation isn't as optimistic as any of us would wish - and realizing what we must do - we can take some degree of solace in the fact that we have been there before and better times will come again, as they have before.
As regards our 2006 appropriation, NCI has just completed a lengthy planning process. As you recall we operated under a continuing resolution until the end of December when Congress passed the appropriation. During January and February, NCI's Division heads and Center directors completed a redeployment exercise begun the prior summer and fall. During these long meetings, we collectively discussed all programs - and even significant individual projects. I can only applaud the spirit with which the divisions and centers set priorities and made some very tough decisions about what absolutely had to be done, what could possibly be delayed, and what we simply couldn't afford to do anymore.
Through this deliberative process, all concerned have told us that highest among our fiscal priorities should be the funding of first-time investigators, should be maintaining the RO1 payline, and should be maintaining the number of grants funded.
Each year NCI also allocates a portion of its resources for competing research project grants, to fund exceptions to the regular payline. This permits the Institute to fund applications that are beyond the payline but that are of high programmatic interest and opportunity. In past years, NCI has allocated around 10 percent of the competing RPG budget to pay these exceptions. In the 2006 fiscal year, because there is a greater need to be able to select grants outside the very-restricted payline, we are holding around 15 percent in reserve for exceptions.
As a researcher and professor, one of my greatest pleasures has been to foster new scientific minds, to mentor a new generation. The support of new investigators has always been a priority at the NCI, and certainly a priority for me during my academic career. During recent deliberations, there was again consensus on the need to protect and sustain new investigators applying for first-time grants. For the last decade, NCI has set the payline for first-time grantees at levels significantly above the average R01 payline, to maintain a constant and consistent number of new investigators funded. We intend to continue this process through our STAR award programs.
I want to pay special notice to the work of Jim Doroshow in leading the Clinical Trials Working Group. The CTWG is now implementing its report produced after 18 months of intense deliberation. The changes being implemented are necessary, in order to position ourselves to rapidly move new therapies through the evaluation process. They are changes necessary to do drug discovery in the post-genomic era. The process of drug discovery and approvals is now made even stronger, thanks to key partnerships with other federal agencies like the Food and Drug Administration and the Centers for Medicare and Medicaid Services. The Interagency Oncology Task Force and the Critical Path Initiative are just two examples of ways we can amplify NCI's effort to bring real change to the discover and approval process.
Finally this morning, I want to remind us of the tremendous responsibility we have. I believe that, in order to continue unparalleled discovery, and to achieve the aims of the National Cancer Program, we must embrace, as part of our portfolio, multidisciplinary team science. I would argue that it is clear from the extensive deliberations of our advisors, that we must find a place for large-scale integrative cancer biology. In addition, NCI cannot afford to wait for new technology platforms to be developed. NCI, as I mentioned earlier, has always been the leader; we must continue to be the leader, getting scientists from fields like informatics, physics, electrical engineering, and optics to apply their knowledge to cancer problems in a team setting.
The efforts of each and every one of you are essential to our cause. Today, patients confront their cancers aggressively; survivors wear their lives as badges of honor. They scour the Internet, they scan library shelves, and they demand thorough explanations from their doctors. Patients know the toll. The people of our world know the numbers: 1-in-2 men; 1-in-3 women; one American dying every minute. Patients want to know: What are you doing for me? Don't tell me about the future; tell me what you can do today. You and I can explain clearly and cogently what we know about cancer biology, why as scientists, we see unprecedented new opportunities and new pathways of discovery. But as I sit on the side of the bed of a patient, my enthusiasm for science isn't the message of hope I need to be able to give. I need to have the therapies of the future.
We should take pride in remembering that, for the first time, there are fewer people dying of cancer. In 1978, there were three million survivors; in 2005, there were more than 10 million. This is real progress, and the direct result of your work.
These incremental steps are the direct result of your work. I don't know of a more exemplary calling than that of a life dedicated to cancer research. I know you will keep pressing forward. I know that, together, we will get the message out about the work you are doing. Together, we will work to eliminate the suffering and death due to cancer.
I end this morning with a promise that there is no one more committed to working with you, working with you to make a difference than I am. I am motivated to this challenge by the memories of holding, each night: a beautiful, intelligent, inspirational woman who was desperately trying to win her battle with breast cancer. Even on the last morning, she said to me, "J," as she called me, "can we talk about trying another experimental drug?"
My friends, you and I are tasked with answering the call of every patient, every survivor, every caregiver, every friend, and every loved one. We are privileged to be their beacons of honesty, support, and hope. God bless each and every one of you, and thank you so much. Thank you all so much for the honor of being here this morning and for the privilege of working for you.
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