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DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES APPROPRIATIONS FOR 1999
Tuesday, March 10, 1998.
NATIONAL INSTITUTES OF HEALTH
WITNESSES
HAROLD E. VARMUS, M.D., DIRECTOR
RUTH L. KIRSCHSTEIN, M.D., DEPUTY DIRECTOR
WENDY BALDWIN, PH.D., DEPUTY DIRECTOR FOR EXTRAMURAL RESEARCH
MICHAEL GOTTESMAN, M.D., DEPUTY DIRECTOR FOR INTRAMURAL RESEARCH
ANTHONY L. ITTEILAG, DEPUTY DIRECTOR FOR MANAGEMENT
FRANCINE V. LITTLE, DIRECTOR, OFFICE OF FINANCIAL MANAGEMENT
DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY FOR THE BUDGET, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. PORTER. The subcommittee will come to order. We continue our hearings for the Department of Health and Human Services with the National Institutes of Health overview of the budget for the fiscal year 1999. We are delighted to welcome Dr. Harold Varmus, the Director of the National Institutes of Health; Dr. Ruth Kirschstein, the Deputy Director, and the other representatives of NIH here with us today.
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Dr. Varmus, this is your fifth appearance before the subcommittee. You have had many more appearances, but this is your fifth formal appearance on behalf of NIH before the subcommittee and as you know we place the funding for the National Institutes of Health at a very high priority in this subcommittee.
I have to give you my short sermonette and that is that the President's budget is very encouraging to me in that he has offered an 8.4 percent increase for the next fiscal year and said that his goal is to increase funding for NIH by 50 percent over five years. The difficulty, the immediate difficulty, is that his spending increases, not only in this but in other areas, is supported by revenues that are very unlikely in my judgment to materialize, at least in this fiscal year.
That will provide some difficulty for us in respect to our 302(b) allocation and in reaching the kinds of levels that we feel NIH should receive, but we will do our very best both with the allocation and with the markup of our bill because, as I say, the NIH is a very high priority for all Members, on a bipartisan basis, of this subcommittee.
My second concern with the President's budget has to do with the cancer initiative and while I certainly support the importance of research in this area, I think that while it may be good politics, it is very bad policy to earmark any disease as being politically important and to take away from science the right to decide where scientific opportunity and progress lay.
So I am very skeptical of the earmark for cancer, but very supportive of providing all the funds we possibly can for cancer research and research with respect to all the work that NIH does and funds.
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We look forward this afternoon to hearing about the remarkable scientific advances that your fine institution makes possible and I would ask that you introduce the people who are with you and then proceed with your statement.
Introduction of Witnesses
Dr. VARMUS. Thank you, Mr. Chairman.
Let me introduce the members that you did not introduce. Dr. Michael Gottesman, Deputy Director For Intramural Research, on my far left, Dr. Wendy Baldwin, Deputy Director for Extramural Research, and Mr. Tony Itteilag, who is the Deputy Director for Management. You have introduced Dr. Kirschstein, whom you know well. On my right is Ms. Francine Little, Director of the Office of Financial Management, and the long-suffering and ever-present Mr. Dennis Williams, who is the Deputy Assistant Secretary for Budget and Management from the Department of Health and Human Services. I would also like to point out that arrayed behind me in a spectacular show of support are the directors of the various institutes and centers which hope to receive the good wishes of this committee.
As you point out, Mr. Chairman, I am here for the fifth time and very pleased on this occasion to be presenting the President's Fiscal Year 1999 budget request for the National Institutes of Health.
Appreciation of Mr. Stokes
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Before I begin my formal comments, I would like very briefly to make a statement about Mr. Stokes, whose presence here I warmly welcome—I only regret that this is going to be for the last time. Mr. Stokes, you have been an enormous friend to the NIH even at moments when you have been most critical of us. I am appreciative of the support you have given and of your dedication to the health of all Americans but, particularly, of those in minority populations who, as you have pointed out repeatedly to us, suffer from disparities in health status that it is the task of the NIH to try to reduce. You have drawn special attention to many problems that especially afflict African-American populations—including sickle cell disease, asthma, eye and oral diseases. I hope that you can take some comfort from the fact that during your stewardship here we have made considerable advances in some of those areas, particularly the use of hydroxyurea in the treatment of sickle cell disease.
I also appreciate the attention you have paid to the training of minority scientists, including your support for the undergraduate scholars program on the NIH campus and for our clinical research loan repayment program. You have made a big difference in those regards. Thank you very much.
Opening Statement
Now, as part of his Research Fund for America, the President, strongly supported by Vice President Gore and Secretary Shalala, is asking for, first of all, $14.98 billion for the NIH for the coming year—an increase of $1.15 billion, which, as the Chairman has already pointed out, is 8.4 percent above our current 1998 appropriation level.
Furthermore, the President has outlined a five-year budget projection that will allow us to anticipate a stable pattern of growth over the next several years to a level of over $20 billion—approximately 50 percent above our current appropriations—by the year 2003.
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Needless to say, we are enthusiastic—indeed, jubilant—about the prospect of building vigorously on the handsome increases that NIH has received over the last few years, when budgetary prospects were more problematic. We believe that this generous request has come at an especially opportune time, and that this is true for two reasons.
BIOMEDICAL RESEARCH DISCOVERIES
First, as I think this subcommittee is particularly aware, discoveries in biomedical research are occurring at an unprecedented pace, and those discoveries presage revolutionary changes in the practice of medicine. At the same time, we recognize that the improved methods of care that we expect to result from these discoveries will improve care at a time when the nation is confronting some very serious public health needs. There are at least three that we need to think about. One is the aging of the human population, both here and abroad. Second, the disproportionate growth of groups in the United States that have historically experienced poor health. And third the persistence of many serious diseases that we have been unable to conquer, not only in this country but in all parts of the world.
I would like to speak for a moment about the promise of science based on accomplishments. As has been the case over the last several years, we come to you with a rich harvest of recent results, and those results come from both the laboratory and the clinic. My colleagues will give you testimony over the next three weeks that will describe in great detail some of this productivity, and some of the specific accomplishments are listed in my written statement. I will not spend the time going over them now.
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I would simply point out two things. First, that they represent an array of laboratory findings which last year I referred to as ''inspirations'' for further work to achieve our ultimate mission of improving the nation's health. Those inspirations range from the isolation of new genes and our progress on a variety of genomes—the collection of genes—to discoveries about the brain and the rest of the nervous system, new insights into functions of cells, and the molecular basis of disease.
RESEARCH ACCOMPLISHMENTS
We also will be reporting a large number of what I called here last year ''culminations'', the work that actually takes those results and puts them to use in the clinic. You will hear over the course of the next few weeks about a number of vaccines, new drugs, the use of devices to reduce morbidity and mortality, new important epidemiological findings, and diagnostic tools.
But beyond these inspirations and culminations, I want to remind the committee of a few advances that have occurred over the last few years that have had dramatic objective effects on the health of this nation, indeed, the health of the world. In these several areas, NIH science over many years has had dramatic and important contributions to make.
For example:
—the virtual elimination of hemophilus influenza B meningitis, which previously occurred at the rate of 20,000 cases per year and was one of the major causes of mental retardation in this country;
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—declining cancer mortality rates, that have gone down nearly 5 percent over the last six years;
—a nearly two-thirds reduction in the transmission of HIV from mothers to infants, and now a reduction in rates that is almost as significant now with the short course of AZT abroad;
—a decline in AIDS mortality rates of 44 percent for the first half of 1997 compared to 1996;
—a marked decline in infant mortality that in recent years has been particularly ascribable to a decline in sudden infant death syndrome of 40 percent due to our Back To Sleep program that you will hear more about later;
—the safety of the blood supply, further secured by definitive tests for HIV, hepatitis B and hepatitis C viruses;
—and a decrease in disability rates for the elderly, to the tune of as many as 1.4 million fewer disabled in recent years than would have been anticipated from 1982 rates.
FUTURE PROSPECTS
In proposing a very substantial increase in the NIH budget, I believe it is appropriate to emphasize our future prospects. In the main what we expect to see, of course, are many new ways to prevent and treat illnesses, using methods that we expect to be based largely on the extraordinary discoveries and technologies that are currently being delivered in many fields of work, especially neuroscience, genetics, cell biology, bio-engineering, computer science and others.
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MOLECULAR MEDICINE
One way in which we can see this change most vividly is by observing a passage that science is currently making from molecular biology to molecular medicine using our knowledge of the large molecules of life to prevent and to treat disease. We discussed here last year the marked improvement in the treatment of AIDS that serves as an incredible example of this approach and also serves as a harbinger of the rational mechanism-based approach to medicine that will be, I believe, the major legacy of current molecular and genetic science.
You will recall that the new therapies for HIV infection are built on an understanding of the relatively few genes and few proteins of the virus. We are beginning to see this pattern now for much more complex illnesses that arise from our own much larger genome.
The next venue in which I believe the impact of molecular medicine is going to be most dramatically perceived is the application of genetics and molecular biology in the study of cancer. This is true for a number of reasons. First, cancer is intrinsically a disease caused by mutations. Secondly, some of the genes affected by those mutations are among the first to have been isolated from animals of the vertebrate class. Thirdly, because the functions of many of those genes are now intimately understood through work in cell biology and biochemistry in the last couple of decades. Because of all of these things, it is now already possible to begin to predict an individual's genetic predisposition to several forms of cancer, to assess the specific genetic damage in individual cancers, to design novel ways to do the traditional things that we do in cancer therapy—destroy cancer cells—and also to take advantage of new knowledge to think about entirely novel approaches to cancer therapy.
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In the very near future our ability to think about new ways to prevent and treat cancer and many other diseases is going to be based on a much more detailed and much more refined view of normal biology and disease. I want to illustrate this important point today by showing you a single new technique among the many recent technologies that have currently become available. [See figure 1]
"The Official Committee record contains additional material here."
EXPRESSION ARRAY
This method is sometimes called the expression array. It takes advantage of the fact that the scientific community has already accumulated large collections of pieces of genes made available by the technologies used in molecular biology and genomics. If one takes hundreds or, indeed, thousands of such individual gene pieces and places them, by using a highly refined technology—based in part on the use of laser jet printers—one can put onto a little slide the size of the one that I am holding in my hand as many as several thousands of genes in an orderly array and then use this chip or array to ask about the activity in each of those thousands of genes in a single cell; to ask whether each gene is turned on or turned off, or to compare the activity of the gene in one cell or another.
I would like to illustrate this with an example that comes from an actual case of a patient who had a T-cell lymphoma that was being treated at the University of Pennsylvania Hospital. During the course of this patient's disease, the tumor that was initially indolent, growing extremely slowly, turned into a much more malignant or aggressive form of the disease. By taking material from the tumor at both stages of development, it has been possible to look at 10,000 genes—10,000 of the available 80,000 to 100,000 in the human genome—and to examine the activity of each of those genes in the two phases of the disease. [See figure 1]
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Now, the colors here indicate what is going on. If a gene is active, it turns up as a colored dot. If the color is red, then that gene is more active in the aggressive form of the disease. If the color is green, then the gene is more active in the indolent form. If the color is yellow, there is no difference. And that, of course, is the case for the vast majority of genes.
As you can see in the blow-up of one small segment of this chip on the right, these results could in the future have direct bearing on the choice of treatment. For example, there is one gene, bleomycin hydrolase, that destroys a drug that is commonly used in chemotherapy for certain—not this one—but certain kinds of cancers. Some of the other genes that are turned on or turned off, such as the ATM gene, are genes that have been implicated in other kinds of cancer and could provide the kind of fingerprint of the cancer that would be useful for instructing the patient about the prognosis, or about the appropriate choice of therapy at that stage. [See figure 1]
IMPACT OF TECHNICAL ADVANCES
In presenting this single technical advance, which is going to have very wide ramifications in medical science, I want to make four additional points.
First, this kind of technology, using modern molecular and genetic methods to look at the disease in the most precise terms, is going to have major applications not only to treatment of disease but also to prevention.
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Second, the method that I am illustrating will have an impact not only on cancer but on a large number of other diseases. We are already using these techniques for AIDS, and they will be used in many other contexts.
Third, this method is only one among many kinds of innovations that I could have illustrated to you today. Innovations that are on the horizon are going to be applicable to visualization of the disease process, to bio-engineering, to repair of disease, to development of devices that will measure brain functions and so forth.
The fourth point is a subtle one. This experiment is the result of a collaboration between Government scientists, university scientists, and industrial scientists, illustrating the kind of interaction that is going to be essential if we are going to control disease in the long run.
FISCAL AND ADMINISTRATIVE RESPONSIBILITY
We believe that increased funding for the NIH would produce better science and better health. But we also believe that increased fiscal responsibility demands close administrative attention. I would like to describe, very briefly, five areas in which the NIH is paying attention to the increased responsibility placed upon us by this budget increase.
RESEARCH GRANTS
The first area is research grants. I have argued here before that the most important instrument that we use to achieve our goals is the individual investigator research grant. In Fiscal Year 1999 we plan to increase the number of grants substantially, to an all time record of over 30,000 grants. We will also set a record for our so-called new and competing grants—the grants awarded in this year of nearly 8,300. That will allow us to achieve an overall success rate for our grant applicants of close to one-third.
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In addition, we are going to be increasing the average size of new grants by about 10 percent. I can describe later on some of the reasons why we feel that it is appropriate to do so.
What are these grants for? The topics, of course, will not be precisely known until the proposals have been written and they have been judged. But we have identified, in priority setting discussions with the Institute Directors, many important research topics to which we expect to devote enhanced resources.
As in recent years, we have approved most of these new initiatives within six broad areas of NIH research emphasis. And initiatives within each of these broad domains would address a wide spectrum of diseases: cancer, diabetes, heart disease, central nervous system disease, and many others. We expect that this expanded grant portfolio to accelerate our discovery and our approach to applications to health across a very large frontier of medical science.
INSTRUMENTATION
The second area is instruments. As medical science becomes more complex, it also becomes more dependent on innovation in instrumentation and multi-disciplinary work. There are many areas of science that have received the benefit of this expanded effort to improve the way in which we measure the performance of biological systems in health and disease. With the resources requested in the President's budget, we will develop new and more powerful instruments. We are going to attract trainees and scientists in many fields to problems posed by technology development in biology and medicine. We will allow more groups of investigators to share instruments through a shared instrumentation program and will expand the use of computers for storage, analysis and exchange of data.
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TRAINING
The third area is talent. We all know that recruiting and training and retaining our most talented individuals is crucial to the success of biomedical research. Attracting people into our field has a long-range impact. Someone recruited this year may not make his most important discoveries until the year 2020; therefore, this is a particularly important responsibility for us.
With this year's budget we plan several strategies to encourage young people to enter these incredibly exciting fields. We will have innovative research training programs that emphasize trans-disciplinary work. We are going to increase our stipends by 25 percent—both for graduate students and for post-doctoral fellows—to come close to the levels previously recommended by the National Research Council. By increasing our general support for research over many years, we will create a stable environment that induces our young and talented individuals in this country to enter medical research areas.
CLINICAL RESEARCH
The fourth general area I would like to comment on is clinical research. We all know that the promises of biomedical research cannot be achieved unless we strengthen the nation's commitment and capacity to perform clinical research. To do this, we have been putting into practice most if not all of the recommendations made by my distinguished Panel on Clinical Research.
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We discussed some of these last year but I want to mention a few new ones that are currently going into the implementation phase. Most recently we announced new programs to enhance the training and support of clinical investigators, a program that will provide a supervised five-year apprenticeship for over 400 additional young clinical investigators; A program that will provide salary support for the clinical research activities of nearly 400 mid-career scientists who have distinguished themselves already and can serve as mentors for new clinical trainees; and a didactic training program that will bring organized programs in training of clinical research to over 20 institutions.
In addition, we will be strengthening our programs at clinical research centers including the General Clinical Research Centers, and expanding new programs on the NIH campus that introduce medical and dental students to the joys and tribulations of clinical research. And we will continue our construction of the Mark Hatfield Clinical Research Center.
We also have a variety of plans to increase our capacity to do clinical trials that are outlined in the written statement.
ADMINISTRATION
Finally, I would like to address four issues concerning our administrative functions at the NIH, because we know that our ability to use money effectively is dependent upon strong administrative practices. First, in the area of grant review. We are renowned for our expert review of grant applications but, nevertheless, we feel that more needs to be done to ensure that we are appropriately reviewing proposals from our grantees. So the Center for Scientific Review has undertaken a thorough reexamination and restructuring of our peer review panels.
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Second, in response to a suggestion from this committee, we last year commissioned from the Arthur Andersen Company a large-scale review of our administrative practices. While this review was generally complimentary, it did include roughly 80 recommendations for improvement and many of these we hope will be implemented in the coming year.
Third, this committee and others have been interested in the way in which we identify priorities for research funding and we have just signed a contract with the Institute of Medicine to carry out a study of our practices in addition to many other activities we have undertaken in this area.
Finally, as mandated by the Government Performance and Results Act, we have incorporated our first annual performance plan with goals and measures into this budget request.
Mr. Chairman, committee members, we are in the midst of a remarkable phase in the history of biomedical research. We have an opportunity before us to create a stable environment for continued discovery that will benefit the citizens of this country and people throughout the world for decades to come.
I hope we can work together to seize this opportunity and to realize its benefits.
Mr. Chairman, thank you for the opportunity to speak at such length, and I am pleased to respond to any questions that you and your colleagues may have.
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[The prepared statement follows:]
"The Official Committee record contains additional material here."
Mr. PORTER. Dr. Varmus, thank you for your opening statement. Let me advise members of the subcommittee that we will operate under the seven-minute rule considering how many Members are at our hearing. We will call on Members who are present at the opening of the hearing, by party, back and forth then to those who arrived in order of arrival with the exception that I will call on Mr. Obey for questions immediately following my own.
DISEASE EARMARKING
Dr. Varmus, I expressed in my welcome to you a concern about the President's budget in respect to the cancer initiative. I have expressed very frequently a concern about the politicalization of science. And I wonder if you had any opportunity during the formulation of the President's budget to raise the question or issue of disease earmarking before the budget or State of the Union message or both were offered?
Dr. VARMUS. Mr. Porter, naturally we have had discussions with the Administration about budget formulation. Just as we discuss with members of this committee their interests, we have discussed the interests of the Administration in various diseases. But the budget was put together in our traditional manner—that is, in response to scientific opportunity and our sense of what is needed.
Mr. PORTER. Did the cancer initiative idea come from NIH or from the White House?
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Dr. VARMUS. Well, I think you would have to—it is, as the Secretary commented—it is a chicken and an egg problem in a sense. The budget as formulated afforded major increases to many cancer-related activities for reasons which I think I spelled out in my testimony—the remarkable opportunities that are available in cancer research, the fact that cancer is going to be a major area in which the fruits of molecular and genetic technology are first applied.
There is the additional fact that many of the infrastructural issues in medical science—clinical trials development, training of clinical investigators—are going to be exercised. So the budget for cancer was large. The identification of a cancer initiative that the President and Vice President have emphasized is a decision made by the Administration but it is completely consistent with the budget numbers that we developed.
There are other diseases that receive increases in the budget equal to or even greater than cancer. But in view of the magnitude of the cancer problem, the public's concern about cancer, and the remarkable advances that we believe have come and are in the immediate future, it has been featured in the President's display of the budget.
Mr. PORTER. In other words, you are saying that the President did not necessarily vault cancer ahead of other diseases, he simply emphasized cancer in the increases that were being provided, and he could have emphasized other diseases in the same way?
Dr. VARMUS. In fact, as I think the budget proposal makes clear, there is a very handsome increase for every disease area. I do not believe that the modest increase in advance of the average for cancer research is discriminatory to other disease areas.
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MIND AND HEALTH
Mr. PORTER. Thank you. We will treat it that way.
Last fall we had some special briefings on the role of the mind in health and healing. Is there any important role of the mind in molecular medicine or does it simply become irrelevant? And if there is an important role, what is NIH doing in terms of its own work in grant funding in this area and what Institutes are involved?
Dr. VARMUS. Well, Mr. Porter, I chose to speak about molecular medicine because it is at the verge of having a tremendous impact on changes in medical practice. But I hope that I made clear that it was only one of many profound changes that are occurring and represents only one area of our science.
We believe that the mind is a manifestation of a physical entity, the brain. What is occurring in neuro-science and the understanding of how activities of the brain affect health are germane to a wide variety of activities carried out by at least a dozen institutes—I could name them if you would like, starting with the Institutes for Mental Health for Neurological Disorders and Stroke, and many others.
The connections between mind and health are being explored by a variety of technologies, ranging from neuro-imaging to classical behavioral work, to attempts to understand connections, for example, between the nervous system and the immune system.
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There is a coordinating function here that is carried out largely by the Office of Behavioral Science and Social Research that attempts to overview the activities of many institutes in understanding the relationship between mental attitude, behavior and health outcomes.
Mr. PORTER. Is there any way that the brain, like other organs, can simply be reduced to dealing with it in respect to molecular biology and not worry about behavior or anything outside of the physical work of the brain?
Dr. VARMUS. Well, I do not think that any of us are interested in learning about molecular interactions without knowing about their consequences. For example, to talk about one fairly simple thing, we know that when a patient uses a psychotropic drug, or uses a drug for the treatment of mental illness, or uses a drug in an illicit way, that there is an engagement between a molecule, namely that drug, and a receptor on the surface of nerve cells. We also know that there is a change in behavior and we can see the places in the brain that respond to the drug. They may even respond to the possibility of obtaining that drug.
The changes that we can see by neuro-imaging combined with our understanding of the molecular events that transpire between the interactions of the drug with the nerve cell and the actual change in behavior, are things that we are trying to understand in order to intervene to prevent the events that produce ill consequences for health.
So I think it is very difficult to separate the molecular components of your question from the behavioral, because what we are trying to effect are the behavioral changes that are desired, using molecular tools for understanding.
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100 PERCENT INCREASE
Mr. PORTER. You mentioned, in a general way at least, how you would use the increases that the President has proposed in his budget, a 50 percent increase over five years. Many are proposing a 100 percent increase for NIH over five years and other research components within the Federal Government. Can you tell us whether you could reasonably absorb an increase of 100 percent over five years and how, if it is different, you might use funding at an increased rate of that magnitude?
Dr. VARMUS. Mr. Porter, I believe that what is going on in medical science at the moment is truly extraordinary, and that the capacity of our research community to make good use of funds is at an all time high.
It is very difficult for me to calibrate exactly where the limit is reached. But we do know that there are many excellent grant proposals that go unfunded, many investigators who have been well-trained and are able to do work who are currently not working at peak capacity. We know that there are areas of research that we under-explore.
And we also recognize—and I give malaria as one example—certain diseases that have greater impact abroad than they do in our own country.
We also know that as we make this transition from a molecular-based science to molecular-based medical practice, there is going to be an expanded need for clinical trials, for general clinical research, both of which are more expensive than some of the laboratory work we do. Animal experimentation has become very important in the last few years as a result of our ability to build truly informative and accurate models of disease in experimental animals. And that kind of research, too, requires additional resources.
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We know that science moves faster with good instrumentation. We have seen many of the programs to understand the full genetic blueprint of organisms moving at a pace that is slower than could be achieved simply because there is a limitation on methodology and on the number of machines available to advance research.
We are entering into a whole new era, that I illustrated with that chip experiment, in which the talents of people who are currently in other fields will be required, mathematicians to help us to understand the dynamics of how a single cell works, or physicists and computer scientists to help us manage the information that has become available and to cope with a new way of thinking about normal and diseased tissues.
So I believe the opportunities are extraordinary and that even as much as twice the current level of funding could be extremely well used.
SUCCESS RATE
Mr. PORTER. I think you said we are funding about a third of the good science that is offered, is that correct?
Dr. VARMUS. This year we will achieve an overall success rate of about 31 percent. But I would point out a couple of things about that number. First of all, that number is not uniform among all the institutes. And secondly, the number is higher for those who are competing for their renewal than it is for our new investigators.
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On average, between 22 and 24 percent of our new investigators receive their first grant. And we know that, first of all, we believe that a higher number of those who went through NIH training programs should have a chance to show their mettle.
We also have recently decided that new investigators should be better supported than they have been in the past. In the past, as you know, over half of our new investigators were receiving an award known as the FIRST award or the R29 award, which gave investigators only $70,000 a year for five years.
In my view, this was not a fair start. A study carried out this year at the NIH strongly confirmed that perception. The Institute Directors voted to end the R29 award and instead ensure that at least the number of new investigators we had supported before would now be supported in our traditional R01 manner.
That is going to cost us roughly $50 million this year and perhaps as much as $500 million over the next several years. But I feel it is very important that our newly trained individuals show what they can do with adequate support.
NEW PROPOSALS FUNDED
Mr. PORTER. Is there any way of investigating if anything of that magnitude were possible; is there any way of estimating what percentage of the new proposals would be funded? Have you done anything like that?
Dr. VARMUS. I am not sure I quite understand what you are asking.
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Mr. PORTER. Well, we are at 22 to 24 percent, I think you said.
Dr. VARMUS. Right. That is for new investigators. And that is the number we anticipate for 1999.
Mr. PORTER. If funding were increased at the rate we are talking about, would that number increase appreciably? Would the 31 percent increase appreciably as well?
Dr. VARMUS. Well, this is a difficult question to answer, Mr. Porter.
Mr. PORTER. I know that it is.
Dr. VARMUS. I have actually asked that we start to do some modeling to try to make some estimates. One of the things I have encouraged this year is that we increase the size of our competing awards as well.
Over the last several years with tight funding it has been practice for most institutions not to allow a significant increase between the first award—that is the initial R01 award—that an investigator might obtain and the level of the competing renewal. The consequence has been that when an investigator is successful, in order to increase the size of the laboratory group it is necessary to apply for a second grant. And, indeed, there are several thousand of our investigators who carry two and sometimes even three awards rather than just one. I would like to move us back in the other direction. It simplifies administrative practices and review and program management, and that needs to be figured into the modeling of the system.
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We are not intending to increase the pool of investigators by expanding the number of training slots. I think I have made it clear in the budget rationale that we expect to increase our stipend levels to bring the stipends up to a more humane level. But we do not expect to increase the number of trainees because we do not believe that it is appropriate to expand this universe forever. We want to make the universe a better one.
Mr. PORTER. My concern is that we have young investigators who get discouraged and leave the field and obviously we want to keep them in if they have good science and good talent.
Dr. VARMUS. If they are doing well, I agree. We have, of course, always had an exit rate. That has been roughly 9 percent per year. And that is a biphasic rate of departure. But we would like to ensure that everyone gets a very good chance to be in the system. If they do not succeed, then someone else is given their place, but I think we agree on this point.
Mr. PORTER. Thank you, Dr. Varmus.
Mr. Obey.
RATE OF BUDGET INCREASE
Mr. OBEY. Thank you, Mr. Chairman.
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Doctor, I have 31 questions which I will submit to you for the record of the Office the Director hearing and I would appreciate a response to them as soon as possible.
Let me begin by going in the other direction from the chair. I, frankly, am skeptical that NIH—and I would appreciate it if you would keep your answers to about a minute apiece, so, I can get at least five questions in—I am very skeptical about whether or not NIH, in fact, has the capacity to absorb the kind of money which is being talked about in the President's budget, particularly in the last two years.
I will ask you to expand for the record, but can you explain to me in one minute or less, why I should believe that that kind of huge expansion will be wisely spent without waste, especially in the last two years?
Dr. VARMUS. Well, Mr. Obey, I think that it helps to recognize that not all the money would be going into grants. We are not simply trying to increase the grant pool and increase the success rate. What we are imagining are new kinds of initiatives and more involvement in clinical research, which is, as you know, expensive. We are interested in developing new aspects of the research portfolio. We see ourselves expanding into areas of instrumentation and bio-engineering that will bring the talents of people in other disciplines to medical research. As we cost out these programs and think about what is possible over the next several years, we do believe that certainly the President's request can be used very well throughout the next five years.
50 PERCENT INCREASE
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Mr. OBEY. Well, let me ask you if you would outline for the record how a 50 percent increase will be used for grants for clinical trials, for training, for intramural programs, for construction et cetera. I would like to know if you could use it. I would like to see how, in fact, you plan to use it right now. If you are still betting we can put a plan together sometime down the road?
I would like to know what decisions have been made now as to where the money will go in the next five years.
Secondly, if you take a look at the stability and the mechanism distribution over the years and you could take this year and last year, for instance, how much change between those categories? Is that a sign that the budget has become too stagnant and locked in, and how much do you expect that distribution to change if we allocate what you have asked us to provide?
Dr. VARMUS. Actually, Mr. Obey, there are some significant changes in the mechanism for this year. One, of course, reflects the change in stipends for trainees. The dollar value is not enormous compared to our dollars invested in grants but, nevertheless, is a very substantial percentage of——
Mr. OBEY. If you look at the percentage changes in your budget——
Dr. VARMUS. It is a very large percentage change actually. And it is about 20 percent change in the training category—or 18 percent.
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Mr. OBEY. I am talking about as a share of your, I am talking about——
Dr. VARMUS. As a share, of course. Because that is, of course—because we have a very large commitment base, as you know. So, I think the important——
Mr. OBEY. Right, but I prefer that we not change terms when I am asking you a question.
Dr. VARMUS. Okay. I was just pointing out that the way we can make changes is by looking at the——
Mr. OBEY. All I am saying is that if you look at what is happening from 1987 through 1996, you may have a 1 or 2 percent change for any of these categories, at most. I would say that is fairly stable.
Dr. VARMUS. Yes, it has been very stable. I agree with that.
Mr. OBEY. And I am simply asking whether that also means it is very stale.
Dr. VARMUS. Well, I think there are two answers to that. First of all, it is only with this year's budget request that we have been able to forecast the kinds of increases that would make some differences in the way the money is divided up.
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I would also point out that what is probably more important is to look within each of those categories at how we are spending our money—for example, on grants and intramural programs, and to ask: What is the quality of research? At this point, to envision an NIH that is fundamentally different in character—that it spends 20 percent of its money on grants and 80 percent on intramural programs, for instance—it would seem to me an arguable possibility for an abstract discussion but I do not think it would be terribly consonant with the reality of where our scientists are and where the buildings are.
CLINICAL RESEARCH
Mr. OBEY. Well, let me ask you with respect to clinical research, I confess that my bias over the years has been that given limited resources we should focus most of our resources on basic research and basic cell biology, et cetera, et cetera. But it seems to me that as the nature of health delivery has changed and as the HMO movement is driving out the ability of physicians to actually do research—they damn near do not have time to see patients.
My question is are you confident that NIH is responding to that change by making a sufficient reallocation of resources to really strengthen what we provide for clinical research? What do you intend to do in the next five years?
Dr. VARMUS. As I mentioned in my opening statement, we think part of the problem requires attention to recruitment and training and the sustenance of clinical investigators.
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And that is why in the last few months the Institute Directors and I have put together a program of new training initiatives and stipends for early- and mid-career clinical investigators which, if they prove successful, could be further expanded.
We are also aware of concerns that clinical research applications may not be getting a fair shake in the peer review process. The Director of the Center for Scientific Review, Dr. Ellie Ehrenfeld, has made special efforts to improve the oversight of that review process.
Thirdly, we have done an evaluation of where our money is going. The numbers of our dollars that go into clinical research activities, as we define them, has been found to be over 30 percent—nearly 40 percent in terms of dollars, nearly 30 percent in terms of grants. And we feel this is a pretty substantial investment, although we expect to see it increase for some of the reasons I outlined a moment ago to Mr. Porter.
REASONABLE PRICING
Mr. OBEY. Let me make this point to follow-up on that, because I am concerned that NIH may be providing some response but frankly not sufficient response to that concern.
Let me ask another question. I have a letter here that has been circulated by Congressman Rohrabacher, Congressman Campbell, Congressman Sanders and Congressman Patrick Kennedy, and it says, among other things, ''that President Bush instituted reasonable pricing costs for drug development largely with government resources at NIH.''
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''Unfortunately, under pressure from pharmaceutical companies NIH cancelled the clause in 1995,'' and then they assert that NIH spent 15 years and $32 million of the taxpayers' money to develop Taxol and then they go on to say that following the successful development of Taxol, the company involved was awarded exclusive marketing rights and extensive government information on the drug. They charge roughly 20 times what Taxol cost them to produce. So, the cancer patients will pay $10,000 a year while it cost the manufacturer only $500.
I guess my question is simply, what do you think we ought to do about this? Is there some happy middle ground that we can find between the original proposition that was in effect under President Bush and the zero protection which we have now?
Dr. VARMUS. It's probably best to dissociate the Taxol case which has been a very contentious one, from the general principle underlying our withdrawal from the reasonable pricing clause. The reasonable pricing clause was subject to a number of workshops early in my term here, and it became clear that the ability of NIH to interact with industry especially in the development of the so-called CRADAs—the cooperative research and development agreements—was being impeded by the existence of this clause, which we had not exercised. We really did not know how to exercise it; we are not a regulatory agency, and it is very difficult to do that. In fact, the interactions between our government scientists and industry have improved significantly with respect to exchanges, material agreements, and formation of CRADAs since then.
I think we have made the right decision and individual cases like the Taxol case simply need to be looked at one by one. I think it is probably too complex to get into here.
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Mr. OBEY. Well, I guess I would ask you to expand further on that for the record because it would seem to me that certainly I want drug companies to recover a reasonable cost and have enough incentive to get into the field, but I also do not want us to have no protection for patients under those circumstances.
It seems to me we are stuck between the two poles right now. Mr. Chairman, let me simply submit the rest of my questions for the record.
Mr. PORTER. Thank you, Mr. Obey.
Mr. Bonilla.
DIABETES RESEARCH
Mr. BONILLA. Thank you, Mr. Chairman.
Dr. Varmus, nice to see you again. You said five years. This is my sixth year so we are almost to the line and I can remember when you first started. You used to have those flip cards you used every time.
Dr. VARMUS. I still have them. I just do not need them any more.
Mr. BONILLA. I would like to start out by thanking you for the comments that you made last fall while you were visiting the University of Texas Health Science Center with Dr. Howe down in San Antonio. We got feedback from some of the doctors there about the nice things you said about the work we are doing on this subcommittee and I appreciate that very much.
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I also would like to get into specifics on diabetes in just a second but I would like a comment as well, I have some concerns not directly related to what Mr. Obey said, but sort of, the President's proposed budget has a great reliance on the tobacco settlement which is very, very tenuous at this point. And I think that, realistically, on this subcommittee we are going to have to assume that that is not going to happen unless we get some indication in the next few weeks or days that that is likely to happen.
But at least it is a nice change to hear that the Administration is interested in giving you more dollars because, historically, this subcommittee has had to carry the water after the proposed budget that we felt was inadequate. So, it is nice to hear that he is finally listening to the need for biomedical research dollars out in the heartland. What I am getting to is diabetes because I am concerned that diabetes has a huge impact on each of these factors, yet it continues to be a low priority for NIH research. I will run through the numbers quickly.
Close to 16 million Americans have diabetes. Diabetes costs this Nation $98 billion each year. Diabetes kills 187,000 Americans annually. Yet your budget request only calls for spending $388 million on diabetes research spending.
The Speaker has noted, saying in speeches around the country, that almost one-third of every dollar we spend on Medicare in this day and age is directly related to problems with diabetes. The question is: Why does diabetes research continue to have a relatively low priority at NIH?
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Dr. VARMUS. Well, Mr. Bonilla, I don't believe it does have a low priority. You will recall last year we had discussions of this topic at the hearings, and in response to some of the concerns that we received here and some of the concerns expressed to us by advocacy groups for patients with diabetes, the NIH underwent a very rigorous review of its entire program. We had a major meeting in September to look for unexplored opportunities in diabetes research, and to try to recruit new talent into the field. We have a very substantial increase for diabetes funding in the 1999 budget request—I believe it is a little over an 11 percent increase overall, which is, among the disease areas, one of the highest.
As you are aware, under last year's Balanced Budget Act, there was a $30 million allocation per year for 5 years to diabetes, 90 percent of which is being used by the NIH through our trans-NIH diabetes research group, and there are many initiatives not only in the NIDDK but in several other institutes that address the problems of diabetics.
So I would submit that we are paying special attention to diabetes at the present time and that it is difficult, in my view, to try to develop any simple one-to-one metric that relates what we spend to what is being spent on care. There are many other issues involved, including the number of years that we have been working on this problem, the scientific opportunities that are available for pursuing it and the number of other activities—for example, studies of the eye or of the vascular system or of the nervous system—that have profound effects upon our approach to the problems posed by diabetes but may not be counted as diabetes research. Those factors are extremely important.
Mr. BONILLA. When I arrived here, just one year before you did, I was a big crusader back then for trying to give diabetes research a bump in funding because it was non-existent for several years prior to my arrival here in 1993. What about the factor, Dr. Varmus, of the country's aging population? And down the road—11 percent, maybe it is a good number right now, but as we escalate into the years, it is going to be even more of a problem than even the figures that I cited to your earlier.
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Dr. VARMUS. We agree entirely that the problem posed by diabetes is one that will increase as the population ages, but that is also true of many other diseases, including cancer and nervous system disorders such as Alzheimer's disease and Parkinson's disease. So we have to consider the effects not just on diabetes but on other diseases as well.
Mr. BONILLA. Well, rest assured we are supportive of the research dollars in those areas as well, so it is not a matter of picking the ones you mentioned over another.
Dr. VARMUS. But I would like to point out, Mr. Bonilla, that I do believe, especially with the increased scrutiny that we are giving to diabetes at present, that there isn't a stone that people believe should be turned that is not being turned.
DIABETES RESEARCH WORKING GROUP
Mr. BONILLA. The Diabetes Research Working Group, Dr. Varmus, what are your expectations of this group? And does the budget request include the resources necessary to begin implementation of their plan?
Dr. VARMUS. The plan that the working group has endorsed is already being followed, through the appropriations in the 1998 budget and through appropriations made available through the Balanced Budget Act. So they are already in gear. They have had a successful first meeting. I was pleased that Representative Nethercutt was able to come to that meeting. That they are already working is a consequence of our having developed a workshop in September that was intended to set out goals for doing research in relatively unexplored areas. There was a blueprint made quite quickly available to this group. Many NIH institutes participate as well as advocacy groups and outside scientists. The group is chaired by Ron Kahn, a distinguished diabetologist from Boston. The group is doing extremely well and has the funding necessary to carry out its plan.
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Mr. BONILLA. I hear the beeper. That says my time is up, Dr. Varmus. I have some questions for the record that I would appreciate you getting back to me promptly on, if you could answer, and I am glad you mentioned Mr. Nethercutt. He is, as you know, a champion in this area as well and has done a lot of good work over the last couple of years in this area.
Thank you.
Mr. PORTER. Thank you, Mr. Bonilla.
Mr. Stokes.
HEALTH DISPARITIES
Mr. STOKES. Thank you, Mr. Chairman.
Dr. Varmus, welcome. Let me at the outset thank you for your very kind and warm remarks at the beginning of this hearing. Let me also say that it has been a pleasure for me to work with you, Dr. Kirschstein, and so many others at NIH over the years. I appreciate, in particular, the responsiveness and the sensitivity that you have had in many of the areas of concern that I have discussed with you, not only in the hearings but also in my office, at NIH and on other occasions we have had to meet.
To remain constant relative to these concerns, let me start off with my first question in that area.
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Recently, the President of the United States utilized his Saturday broadcast to speak to and address the very same concerns that I have discussed with you and your associates for many, many years. And, I guess that as I get ready to close out my career, I leave with some very real concerns in that area.
Seated next to you and behind you are the finest scientists and doctors in the world, and it seems to me that I have to utilize whatever I can in order to try and impress upon all of you the absolute necessity for us to try to make some type of a dent in the disparity between white and minority health in this country.
Obviously, the President is also concerned because he has included in this budget $80 million for a special race initiative. I think for the record it would be important to me if you could tell us where we have come since 1985 when we had our first report. That report told us about the excess deaths and other disparities, where we are today and whether our budget today really addresses our being able to seriously reduce, to cease, or terminate the disparate gap between white and minority health.
If you could just tell us where we are, I would appreciate it.
Dr. VARMUS. Well, as you know, Mr. Stokes, we have not narrowed the gaps as much as you and I would like. The President has selected six emphasis areas for the coming few years, and we have major investments in all those areas. We feel it is particularly important that we use our resources for communication of medical information.
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For example, in the area of sudden infant death syndrome, we know that the reduction in death from that syndrome has been much more appreciable in the majority community than it has been in the minority communities. We believe that part of the problem is not using the right tools to reach the minority households where sudden infant death syndrome is still occurring at too high a frequency.
I believe this is also true with respect to bringing individuals into screening for breast and cervical cancer and for making an early diagnosis of diabetes.
In all the major areas in which the discrepancies exist, there is a deep investment in clinical and basic research, and, of course, that investment will improve outcomes for all Americans. But as you know, in the last several years in particular, we have focused our attention on the minority issues specifically and insisted on minority representation in those studies in the hopes that we will begin to level the playing field. But it hasn't been entirely successful.
I would be happy to provide some numbers for incidence and mortality rates in the areas that you have highlighted in your Black Caucus meetings and provide those, as I mentioned, for the record.
PRESIDENT'S INITIATIVE ON MINORITY HEALTH
Mr. STOKES. Will this new initiative that the President has put in his budget help?
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Dr. VARMUS. It has focused our thinking, and I believe it has been beneficial for us to have this initiative. As you know, we have ourselves been very concerned about these differences, both as a result of your drawing attention to them and our own perception of morbidity and mortality data that we collect and look at very closely as we think about the problems we are trying to solve.
But I do feel heightened attention to some of the six specific problems that he has outlined as worthy of special attention will energize us.
ROLE OF ORMH
Mr. STOKES. How about the Office of Research in Minority Health? Do you see that office playing a larger role in this whole picture?
Dr. VARMUS. Well, as you know, Dr. Ruffin, who runs the office, has been coordinating minority health efforts. His budget is slated for a very substantial increase in the 1999 budget. We have been working very closely with him and are about to meet with his advisory council to ensure that we are encouraging the institutes to follow all the appropriate leads on research that will benefit minority health.
He is an integral player in the process, and his office has performed very well.
HIV/AIDS IN THE MINORITY COMMUNITIES
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Mr. STOKES. Let me ask you about another area. The Centers for Disease Control testified here a few days ago, and one of the most stark facts that they brought out to us at that time was that the HIV/AIDS problem in the black community is now seven times that of the white community. This, of course, is a reason for great alarm.
Can you tell us what NIH is doing relative to this problem?
Dr. VARMUS. Well, we have been aware, of course, for some years that particularly in the inner cities and in minority communities—Hispanic as well as black—AIDS is having a disproportionate effect.
The general approach that we have been taking, of course, is to understand the basic damage that HIV does to individuals, find therapies, seek leads that might allow us to make an AIDS vaccine, and do behavioral research that attempts to seek ways to better prevent the transmission of HIV infection.
In response to the President's initiative, which includes, as you know, HIV/AIDS among the targets, we have some plans for improved efforts to communicate preventive strategies to minority communities, and we hope those will be successful. But the amount of additional investment in HIV/AIDS as a consequence of the initiative is relatively modest.
Mr. STOKES. Thank you very much, Dr. Varmus.
Thank you, Mr. Chairman.
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Mr. PORTER. Thank you, Mr. Stokes.
Mr. Dickey.
SUCCESS OF NIH FUNDING
Mr. DICKEY. Hi, Dr. Varmus. I want you to know that in some parts of my rural district we have people who are rather elderly now who don't know that after the Depression hit in 1929 things improved for the rest of the country. It has all been the same to them. As I watch the number of dollars that have been put into your agency increase every year, I just wonder if you know that there have been hard times for other agencies around here in Washington.
Dr. VARMUS. I do know that.
Mr. DICKEY. You are living in kind of an embryo of some sort, some type of protection, and I don't understand quite how we are going to justify it, but I guess we are going to. We have for the last three times I voted on this appropriation bill. I want to congratulate you on what you have done.
Dr. VARMUS. I appreciate it.
DIABETES RESEARCH INVESTMENT
Mr. DICKEY. I understand that over the past year NIH has undertaken a number of critical initiatives related to diabetes and its complications. The budget for NIH has increased 101 percent, and diabetes over the past 10 years has only increased by 35 percent. If we were to find more money for diabetes, how would you put that money to use? What else could be done?
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Dr. VARMUS. Well, Mr. Dickey, we in a sense faced that problem last year, and, you know, we are only as good as our ideas. It is not as though there is a cure out there to be purchased. When faced with this question last year, we pulled together the best minds in the country to think about the various components of diabetes research—genetics, clinical research, metabolism—and asked them, what are the things that are underserved? What should we be doing more work on? And we came up with a series of important initiatives. At least four major initiatives that emerged from that workshop and are being funded by the Balanced Budget Act funds, and there are several other intiatives that the NIDDK has put together.
There may be others we ought to be initiating. Right now there are exploratory grants in certain areas. There is a very extensive interest on the part of several institutes to understand the genetic basis of diabetes. There are new drugs. We believe that there is reason to make an investment in the bioengineering devices that might allow us to sense glucose levels better.
I don't think that there are totally unexplored areas. I think we could expand some of the areas that we are looking at. Right now I think, reasonably appropriate investments are being made in the current fiscal year and projected for the next fiscal year. Those could be strengthened, but I think in balance with our obligations and opportunities in other areas, we are making a reasonable set of decisions.
Mr. DICKEY. Well, you say there is no stone being unturned and no one would complain, but I have a friend named Duke Roos and his wife, Barbara, who lost a 32-year-old daughter, Debby.
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Dr. VARMUS. You mentioned that last year, yes.
Mr. DICKEY. They would think that there is some stone that has not been unturned.
Now, what I want to ask you is, you are saying that you are satisfied and everything is fine, but there are people out there who are not agreeing with you. How do we reconcile that?
Dr. VARMUS. Let me draw a distinction, Mr. Dickey, between pursuing scientific possibilities and achieving the ideal outcome.
We are very far from having a perfect treatment for diabetes. People suffer and die from the complications of both Type I and Type II diabetes every day.
When I referred to stones turned and unturned, I was referring to identifiable areas of research in which we are investing in the hopes of finding better ways to control and revert the complications of diabetes and the metabolic manifestations.
So I understand that we have not achieved the goal that we have set for ourselves in this area, but I do believe that all the identifiable research activities that we could undertake are in general being undertaken.
Now, could we do more in those areas? Very likely. Could we attract more talent? Yes, very likely.
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OBESITY AND NUTRITION
Mr. DICKEY. Okay. To stay within my time, let me change the subject. My developing interest in preventive health care leads me to ask questions of you related to obesity and nutrition. Can you tell us how obesity is defined?
Dr. VARMUS. It is defined in relation to norms established, I believe by the National Center for Health Statistics, and it represents a certain percentage above the average. I would like to submit that for the record. I am aware of the definition, but I don't have the precise numbers.
[The information follows:]
OBESITY AND NUTRITION
Mr. DICKEY. Can you tell us—could you help me with how obesity is defined?
Dr. VARMUS. A recent publication of the latest data from the full National Health and Nutrition Examination Survey III (1988–94) divides the U.S. population into several categories delineated by Body Mass Index, or BMI, which is a measure of weight compared to height. The categories used to describe overweight are: pre-obese (BMI 25.0 to 29.9), class I obesity (BMI 30.0–34.9), class II obesity (BMI 35.0 to 39.9) and class III obesity (BMI equal to or greater than 40.0). Thus, overall, a BMI equal to or greater than 25.0 is defined as overweight. By these measures, for the U.S. population age 20 years and older, the prevalence of overweight is now almost 55%. In the various categories, the prevalence is approximately: 33% for pre-obese, 14% for class I obesity, 5% for class II obesity, and 3% for class III obesity. I'd like to clarify one point about these definitions. They are used for overall classification of populations, not for diagnosis of an individual's degree of obesity. Because individuals vary in their body composition and their body frame, someone who is very muscular might not be overweight even at a BMI substantially greater than 25.0. On the other hand, someone with a very slight frame who has little muscle might be overweight at a much lower BMI.
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Mr. DICKEY. What do you perceive to be the extent of obesity in the United States?
Dr. VARMUS. It is the only risk factor for cardiovascular disease that is actually increasing. The other major risk factors—blood pressure, smoking, and cholesterol levels—are all declining. So it is a very appreciable problem, and the NIH has a trans-Institute obesity study group that is coordinating efforts to combat obesity. We believe it is one of the most significant health problems we face as a Nation, with many possible approaches. There have been tremendous advances in the last few years in our understanding of how appetite is controlled. We also understand the important component that is played by behavioral research and efforts to increase exercise activity and control diet by methods other than medication. And we understand that it affects a very large number of body systems.
Mr. DICKEY. How much are you allocating to the research of obesity?
Dr. VARMUS. I don't know if we collect that number. I don't believe we do. But I can tell you that it is a very large figure if we put together the behavioral and the metabolic—diabetes-related—and, of course, many kinds of studies of heart disease and cancer that deal with the problem of obesity. It may be rather difficult to sort out a totally accurate number for you.
Mr. DICKEY. I will ask another question that might be difficult. What is the estimated cost to our society of obesity?
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Dr. VARMUS. I would be hesitant—it would depend a great deal on how you decided to measure it, whether that would include the cost of trying to treat it, the cost of the illnesses that are influenced by it. Certainly many billions, but I would prefer to defer to my economic advisers before giving you a number for the record.
Mr. DICKEY. Thank you. My time has expired.
Mr. PORTER. Thank you, Mr. Dickey.
Mrs. Lowey.
RECOMMENDATION OF DIABETES CONFERENCE
Mrs. LOWEY. Thank you, Mr. Chairman.
Dr. Varmus, I want to thank you for your testimony and welcome you and the other doctors who have joined you here to our committee this year. I am pleased that Dr. Kirschstein and Dr. Varmus as New Yorkers are here and that you understand the importance of medical research. He was originally born in New York. [Laughter.]
Mr. HOYER. So many of us were.
Mrs. LOWEY. I mention that, Dr. Varmus, you know, the incredibly importance of the National Institutes of Health to the medical community in New York, and we appreciate all the important work you are doing.
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Before I move on to my questions, there have been several comments or questions about diabetes, and I just want to thank you for your comments, and if you could submit for the record or to my office the implementation that you feel will result from the conference findings. At the conference there were recommendations, and I would be most appreciative, because there are many of us on the committee who represent constituencies who passionately care about research in diabetes, and I would be most appreciative.
Dr. VARMUS. We can send that to you very promptly.
CLINICAL RESEARCH AWARDS
Mrs. LOWEY. With regard to clinical research, I appreciate your comments today. As you know, I have again introduced the Clinical Research Enhancement Act that was originally inspired by the 1994 IOM recommendations addressing the clinical research crisis. The lack of research resources and the financial barriers to attracting and maintaining a pool of talented M.D.'s to research careers as detailed by the IOM in their report unfortunately still exist today.
I am very pleased, Dr. Varmus, that the NIH is proposing new clinical research awards. These awards, however, are very similar to those recommended by the IOM and echoed by the NIH clinical research panel led by Dr. Nathan.
However, my concern is that in the 4 years since the IOM report was issued, the crisis facing clinical research has worsened, and there is concern that these awards may simply not be sufficient. In addition, my understanding is that at least one of these new awards is replacing a current clinical research award program.
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I want to understand these awards, and, therefore, I would like to ask a few clarifying questions.
K–23 AWARDS
The NIH is proposing K–23 awards to young investigators. It is my understanding that this new program will replace the 140 clinical associate position, or CAP, awards that are currently funded—it feels like alphabet soup here—through the GCRC. Is that the case?
Dr. VARMUS. I am glad for the opportunity to clarify that. The award has been confused both the K08 and with the CAP award. But, indeed, what we are proposing here is in addition to those.
Now, it is possible for individuals who currently receive these other awards, like the K08 or the CAP award to be converted to this new award, the K23. But we are committed to at least 80 new K23 awards each year over the next 5 years, and the number could indeed be larger as a result both of conversion of individuals from one of the others—but these are not substitute awards. They are in addition to the current level of clinical research training.
K–24 AND K–30 AWARDS
Mrs. LOWEY. It's confusing and I have been trying to understand this. What number of K24 and K30 awards are you proposing in FY99?
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Dr. VARMUS. Well, in '99 we are talking about roughly at least 80 new K23s. Those are the awards to clinical trainees who will have a mentor, who will be undergoing training over five years.
The K24 awards are for more senior people who already have faculty positions—are at junior or intermediate or even possibly in some cases senior levels on faculties. Those individuals have already demonstrated their capacity to do clinical research and serve as mentors. There will be in the range of 60 to 80 new awards in that category in 1999. It is a five-year award and renewable once. We expect to build up to a cohort of roughly 350 to 400.
The third award is a didactic award to institutions and we expect to make that award to at least 20 institutions that now have or will soon develop a significant number of clinical trainees. These may be sponsored by us or by other organizations, because, as you know, we are not alone in training clinical investigators. The didactic award is intended to develop a course program specific for clinical research training at those institutions that qualify.
STATUS OF CLINICAL RESEARCH AWARDS
Mrs. LOWEY. Just for the record if I could request the total number of new clinical research awards that you are proposing for FY99 and the number of clinical research awards you are proposing to phase out. What are the new ones you are proposing and what are the numbers you are going to phase out?
Dr. VARMUS. We are not proposing to phase out anything. The other award categories still exist, but the Institutes may decide to support those awards to convert them to K23s. That would be in addition. There is no simple conversion. The point is that the number of trainees is going to go up by a very substantial amount.
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Mrs. LOWEY. Could we have for the record the total number of new clinical research awards you are proposing in FY99?
Dr. VARMUS. I think I just gave you those numbers.
Mrs. LOWEY. What is the total number?
Dr. VARMUS. Of new ones?
Mrs. LOWEY. Yes.
Dr. VARMUS. It will be 80 new trainees, at least, in addition to the existing trainees.
Mrs. LOWEY. Okay. So you are saying there will be 80 new ones but some of the old categories just may not be funded.
Dr. VARMUS. No. If those categories are retained by the institutes, then they will continue to pay new individuals in those programs. There is no simple conversion of an old program to a new one. It is all additive. So whatever the base was before would be built on. This is not a hat trick. This is not a substitution. It is an increment.
Mrs. LOWEY. Is my time up? Oh, my goodness. Let me just conclude, then.
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If we could clarify for the record, I would be most appreciative because there seems to be some confusion or misunderstanding in the community as to the actual increase in clinical research positions.
Thank you, Mr. Chairman, for your indulgence.
Mr. PORTER. I don't know why, but seven minutes does seem a lot shorter than eight minutes. Thank you, Mrs. Lowey.
Mrs. Northup.
Mrs. NORTHUP. Thank you, Mr. Chairman and thank you, Dr. Varmus. I have really learned so much in the last year about what NIH means to this country and to so many people and how many challenges are unmet in so many different ways in terms of health itself and quality of life. And I really thank you for what you all wrestle with.
Every day those of us on this committee meet people that represent organizations or actually constituents in our districts that are affected or afflicted and depend on NIH research for their future. I say it is the closest to trying to be Solomon that probably any of us have ever been.
One of the things that I have most appreciated and learned from our committee chair, quite frankly, is how important it is not to let politics make decisions that science should make.
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I would just like to ask you whether you agree. First of all, I feel like we are challenged not to let a political base divide up research dollars, and I wonder how effectively NIH itself is able to do this. For example, do you experience what many of us experience every day, where organizations that represent people with like afflictions come to see you and ask for increases in research dollars?
Dr. VARMUS. I think in the aggregate that probably is true every day, that we do have our advocacy groups come to the NIH to describe their interest in our activities and to give us a hand. Frankly, what I find most useful about those interactions is not the concern for funding but the offer of help. Patients can provide a special perspective on the diseases we are trying to combat. Many of our advocacy groups are extremely well informed about the issues, understand the grant portfolio, know investigators, and are very helpful in our decision-making processes.
CO-FUNDING OF MERITORIOUS SCIENCE
Mrs. NORTHUP. Let me ask you, do you find that there are projects that are joint funded and does NIH agree with that, and do you ever find that a group might offer to joint-fund a project that might actually have a vested interest in what the research would come out? How do you make sure that the research is uncorrupted, I guess, uncorrupted in a broad sense?
Dr. VARMUS. We do have such collaborations. We have quite a few of them. Sometimes they occur directly through our offices. Most investigators in this country are funded by more than one source, so we know that, in a sense, we are collaborating with many advocacy groups and professional societies because we are supporting the same investigators.
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There are, however, a number of examples of actual cofunding. One of the most prominent is the cofunding that goes on between the Juvenile Diabetes Foundation and NIH of certain diabetes initiatives and centers. That is carried out, actually, with as many as four different institutes.
The advantage to the outside organization is that we provide the peer review, and the advantage to us, of course, is that it allows us to extend the use of our monies.
FUNDING OF PEER REVIEWED RESEARCH
Mrs. NORTHUP. But is there any worry that, for example, if you know you have a million dollars and somebody is going to offer a $2 million match for that million if it is spent in a certain way compared to another disease or challenge that has no match out there for it, that you would be more likely to say, ''Well, we get $3 of research for every dollar here?''
Dr. VARMUS. Well, I wouldn't deny the possibility of that happening. But among the many responsibilities with which my Institute Directors are entrusted, one of them is to evaluate such proposals, to bring those proposals to their councils, and to ask for an informed opinion about whether this is a good idea.
POLITICIZATION OF RESEARCH
Mrs. NORTHUP. I think one of the concerns I have is if those of us on this committee agree that there should not be a politicization of research and we try hard to resist that and depend on the most promising and emerging science to make those determinations, I would want to know that that didn't go on in any other area of government, too in the executive branch or in any of the Cabinet departments that may benefit from your research.
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I wonder what reassurance you could give me that there is not this relationship, especially now that we see the cancer initiative. Maybe we would resist that sort of politicization, but that there would be forces equally unscientifically based that might succumb to it.
Dr. VARMUS. Well, Mrs. Northup, I understand your anxiety on this topic and I share it. On the other hand, I would point out that the distribution of funds that is eventually achieved by looking at public health problems and scientific opportunities is not going to result in a budget in which everyone gets exactly the same level of increase or exactly the same number of dollars.
I do think that it is appropriate for us, as we develop our budget based on scientific opportunities and new areas of emphasis, to say to the public, ''Here are some diseases that are going to be benefitted by the investment we are making across these scientific frontiers.''
Mrs. NORTHUP. Yes, but it is only if you have one of those and your life depends upon that research that that really is very meaningful to you and there are some of those groups in my district and they are very concerned and they are very desperate. I would hate to think that I was depending on the purity of reasoning where not everybody else is playing by the same rules.
DISEASE FUNDING
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I would like to ask you another question. That is about the relative amounts of money that are spent for diseases. I think on this committee in particular we are constantly bombarded with organizations who tell us how little relative money is spent on the addressing of treating or investigation of their diseases and I wondered if those figures come actually from NIH and if they don't, how correctly independent organizations would be able to total up the dollars that are spent to investigate——
Dr. VARMUS. I appreciate that question, Mrs. Northup. As I have said here before, it is difficult to come up with a number for a specific disease.
The numbers that we determine are largely numbers that respond to requests from Congress—perhaps even five or ten years ago—and the numbers are developed with a definition that was provided at that time.
As you can well appreciate, the way in which we ascribe research dollars to a certain disease can vary dramatically based on the definition. I think we have discussed before the difficulty of saying, for example, what constitutes research on, say, Alzheimer's disease or on diabetes. How do you tote up, for example, the dollars that go into the basic research that leads to discoveries about a specific disease?
Now in the diabetes arena, for example, we are faced with enormous opportunities to intervene in the basic metabolic defect because of basic research on the way in which a cell senses a signal and responds by changing patterns of gene expression, as I was illustrating earlier. Such research was not classifiable as diabetes research in the past but its impact on our understanding of diabetes is profound.
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Mrs. NORTHUP. Thank you.
Thank you, Mr. Chairman.
Mr. PORTER. Thank you, Mrs. Northup.
Mr. Hoyer.
POLITICAL INFLUENCES
Mr. HOYER. Mr. Chairman, thank you very much. I do not think I will pursue the purity of peer group procedures and the total lack of politics with peer group review committees, but I have talked to a lot of my friends in the academic community and sometimes find that even they are somewhat involved with political influences.
Indeed, we have a system of political influences and we are dealing with their dollars. And when they talk to us about how they would like to have their dollars spent, it seems to me it is not unreasonable for those of us who listen to them, who were sent here to represent them, to express their preferences.
But that notwithstanding, let me talk a little bit about——
Dr. VARMUS. I hope I didn't seem to say that those influences didn't exist. Of course they do and we are responsive to them, as you know.
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Mr. HOYER. Doctor, there are a lot of people in the room to communicate with. I know exactly.
Doctor, I want to thank you and Dr. Kirschstein in particular and all of you. Mr. Stokes and I were commenting and he referenced it, the incredible intellect and integrity that exists in this room at this very moment. It is always impressive to me, the quality of people that we have serving the American public and indeed all the people of the world, because obviously NIH has an impact worldwide as the premiere biomedical research organization.
Mr. DICKEY. Which side of the table are you talking about? This side?
Mr. HOYER. I am still praying for you. I want you to know that. [Laughter.]
And there is an extra chair over here any time you want. We have, however, studying the neurological disorders that lead one to be a Republican but we have not come up with an answer yet. [Laughter.]
Mr. DICKEY. Is his time over? [Laughter.]
DEFINITION OF CLINICAL RESEARCH
Mr. HOYER. We are the break in the monotony.
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Doctor, going back to clinical research that Congresswoman Lowey was talking about, would you comment perhaps a little more broadly about the definition of clinical research because we are all hearing about 15 percent, 30 percent. The problem is how you define clinical research. Can PhDs do clinical research? Do MDs do clinical research? Would you comment on that? My office has received a number of inquiries on that.
Dr. VARMUS. Let me just say, without going into boring detail on this topic, first of all, the definition used by the IOM—the Institute of Medicine—report a few years ago was much narrower than ours. Ours, however, encompasses many kinds of interactions, all of which involve patients. That is, it is not clinical research to simply work on a sample that comes from a human being. There has to be some need to interact specifically with certain patient groups. That does include certain kinds of behavioral research. It does include epidemiology.
The definition that we use now includes a collection of clinical research activities that range from clinical trials to what is sometimes called translational research, in which the individual patient is under study with respect to the development of the disease or response to certain kinds of interventions.
FOOD-BORNE ILLNESSES
Mr. HOYER. Okay. Well obviously, you deal with that daily.
Food-borne illnesses. Doctor, can you tell me briefly what kind of resources we are dedicating to NIDDK or other institutes as relates to food-borne illnesses, obviously a growing concern in this country?
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Dr. VARMUS. We don't seem to have a number but I know that it is in the range of $53 million for NIAID for next year, and the number for NIDDK, I believe, is just slightly less than that. But both Institutes are aware of the increasing toll that food-borne illnesses are taking in this country.
There was an interesting article in today's New York Times, in fact, about the impact of improved eating habits on food-borne disease, in the sense that we are importing a lot of fruits and vegetables. It is a little bit like being in a developing country every day and exposed to some of the things that a meat-eater and someone who eats stewed turnips is unlikely to be exposed to, as opposed to someone who is eating fresh strawberries and raspberries that have recently come off the fields in Central America.
Mr. HOYER. One of the frustrations, I suppose, of us all is that today we are told that item A is bad for us and that item B is good for us.
Dr. VARMUS. The food is still good. It is just that you don't want it contaminated with bacteria.
AUTISM
Mr. HOYER. It is a moving target sometimes, of course but I am glad to hear that food is good for us.
I will not ask you a specific question but I will at some point in time have a question about Rett syndrome. As you know, I am very interested in that. There is no reason that you should know about it particularly. It is a very small program.
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Let me ask you about this. You have referenced and some others have, also, some compelling testimony from Dr. Rothman, Congressman Rothman's brother who has an autistic child. And we get this argument that you spend X here but there is a bigger problem over here that you do not spend as much on. Obviously you have to deal with that and we have to deal with it.
But can you tell me where we are on autism, what your thought is on the relative contribution we are making to deal with autism?
Dr. VARMUS. Well, in the several years that I have been at the NIH, the attention being given to autism by at least four of our Institutes has increased by leaps and bounds. We had a very important workshop about three years ago at which a number of scientific opportunities were identified in neuroimaging and genetics, molecular biology, and behavioral approaches to autism.
It is now recognized that autism is actually a spectrum of disorders with very different characteristics, and the four institutes that are involved have increased their financial commitment to autism research by large percentages.
Now, the current funding level is roughly $20 million but I could get the more precise numbers for you for the record.
Mr. HOYER. If you would. I know Congressman Rothman in particular, is interested but obviously a broad spectrum of people are interested, as I am and everyone on the committee. Thank you.
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I want to say also that Dr. Penn was very kind to come visit in my office and spend some time with me and bring me up to date. She gave me, I don't know whether it was a book or a report on the autism meeting. I don't know whether it was that meeting to which Dr. Varmus referred.
Dr. VARMUS. It probably was. That was the large meeting we had.
Mr. HOYER. I provided a copy of that to Steve Rothman and I appreciate, Dr. Penn, your coming by.
Mr. PORTER. Thank you, Mr. Hoyer.
Mr. HOYER. My time is up.
Mr. PORTER. Despite your partisan comments I am going to call on two Democrats in a row. Ms. Pelosi.
Mr. HOYER. Said in jest, Mr. Chairman, as you know.
BEHAVIORAL CHANGES
Ms. PELOSI. Maybe three, Mr. Chairman. Congresswoman DeLauro is here.
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Thank you, Mr. Chairman. I want to join my colleagues in welcoming Dr. Varmus and Dr. Kirschstein to the committee today, as well as the array of excellent leaders of the NIH that are with you today. Although born in New York, you made a very valuable contribution to the University of California at San Francisco and any chance I get I like to talk about that great institution. And it was UCSF that Dr. Varmus attended.
One of the advantages of coming late in the game here in terms of asking questions is that so many of the questions that I had have been addressed and I want to associate myself with the concerns of Mr. Dickey and his discussion of behavioral change, whether it is obesity or smoking, whatever those issues are. That is a very important issue in prevention and I will submit a question on that for the record.
DIABETES
As far as diabetes in concerned—and I am sorry Mr. Bonilla left because I would like him and others to know that tomorrow my Medical Research Caucus is having the subject of diabetes as our focus. I think the Speaker is even coming to that and, of course, you know that our scientific leader of the caucus is Dr. Michael Bishop, chancellor-designate of the University of——
[Laughter.]
Ms. PELOSI. I don't know if he will still be able to help us on this caucus once he takes his full responsibilities as chancellor, but he is the co-laureate with Dr. Varmus. [Laughter.]
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Mr. HOYER. You are pleased to bask in the glow.
Mr. DICKEY. Are you all just having a regular conversation? Would you like to share with us what in the world you are talking about?
Ms. PELOSI. I just said great things about you. I associated myself with your remarks.
Mr. PORTER. And you are going to be charged for the time, also. [Laughter.]
Ms. PELOSI. Enough of that.
Mr. HOYER. She is in a safe district or she wouldn't overcome it.
Ms. PELOSI. Well, I will skip over the stuff about our distinguished leader, Mr. Chairman.
Mr. PORTER. Well, I will give you extra time.
OUTREACH IN CLINICAL RESEARCH CENTERS
Ms. PELOSI. I have to go really fast because I do have some questions. I would like to submit my specific question about clinical research centers for the record in terms of the budget priorities and ask a little different question.
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In your testimony, Dr. Varmus, you said that in relation to the GCRC you will continue the loan repayment programs for clinical trainees from disadvantaged backgrounds. I wondered what else you were doing in terms of outreach for research patients at every step of the way in these clinical research centers to ensure that the position the President has about removing the disparities of race in terms of illness, using those centers as one place where we could implement an outreach into the communities.
Dr. VARMUS. I am not sure of the focus of your question, Ms. Pelosi, but I would point out that——
Ms. PELOSI. What are you doing other than loan forgiveness?
Dr. VARMUS. Loan forgiveness, unfortunately at this point, only applies to clinical trainees at the NIH intramural program. We would be interested in trying to develop a loan repayment program extramurally but that requires additional authorization to NIH.
Ms. PELOSI. But what are you doing at the clinical research centers?
Dr. VARMUS. Well, a number of things. I point out that the ''general clinical research centers''—GCRCs—comprise roughly 25 percent of our clinical center activity. Much of the other is, of course, disease-specific—cancer, diabetes, Parkinson's.
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DECLINE OF GCRC BUDGET
Ms. PELOSI. If I may, is it so, and recognizing that large percentage, it is my understanding that your GCRC budget has declined as a portion of the NIH budget from 3 percent to 1 percent?
Dr. VARMUS. Well, in the current proposal we are going to be increasing the number by, I believe, roughly 12 percent over the '98 level.
The results of the deliberations of Dr. Nathan's clinical research panel suggested that the GCRCs ought to take on a more central role in clinical research training and coordination at the campuses at which they are located. We are trying to identify those that show the promise to carry out those extended activities and proposing to give them a larger stipend with which to operate.
PRESIDENT'S INITIATIVE AND GCRC OUTREACH
Ms. PELOSI. I would hope that they would be reflective of the problems of women in what they are set up to do in relationship to the President's initiative.
Dr. VARMUS. Well, certainly all clinical research activities—all clinical trials proposals—now must include explicit descriptions of how women and minorities will receive equal treatment. That has been true for several years and that will still be true.
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CANCER INITIATIVE
Ms. PELOSI. I appreciate your emphasizing that point. I am sorry to intervene.
You note in your statement that the next dramatic transformation of medicine in molecular biology is likely to occur in the study of cancer and I draw from that that that is why this initiative on cancer is being set forth, because of the opportunity that you describe.
Dr. VARMUS. Yes. And I don't mean to say that there are not similar opportunities for other diseases, but this is closest to the clinical interface, in my view.
Ms. PELOSI. That is very good news.
NIH's Office of Research on Women's Health. I will submit for the record some questions about what actions are currently being taken by NIH to meet the Office of Women's Research mandate because I want to put a couple of other questions on the record.
INTERNATIONAL HEALTH
When Secretary Shalala was here she talked about an international cast to some of what was happening and said you might elaborate on some of that when you were here. Some of us serve on the Foreign Ops Committee that does the appropriating and sometimes even on health issues.
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Dr. VARMUS. Well, I am pleased to have that opportunity. My own view is that it is in the interest of this country to pay attention to health problems of countries abroad, not simply for altruistic reasons but also because the economic and political stability of those countries is strongly influenced by health.
Moreover, health is an arena in which we can improve the cultural, and scientific, and educational infrastructures of those countries. I have seen this most clearly in my own activities on malaria, a disease which is clearly very uncommon in this country. It is largely imported when it occurs here. It is a tremendous global problem, causing as many as 3 million deaths a year and infecting 300 to 500 million people around the world.
We are carrying out a strengthened program on malaria research. We think that genetics and immunology have taken us to the point where there are remarkable new opportunities to combat the disease, both through research carried out in this country and through strengthened our collaborative interactions with research partners in Africa, Asia and South America.
Ms. PELOSI. Thank you very much, Dr. Varmus.
Thank you, Mr. Chairman.
Mr. PORTER. Thank you, Ms. Pelosi.
Ms. DeLauro.
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OVARIAN CANCER
Ms. DELAURO. Thank you very much, Mr. Chairman.
Thank you and I apologize to you, Dr. Varmus and Dr. Kirschstein and the directors of the NIH for not being here at the outset.
We had a wonderful visit from the President to the State of Connecticut at a meeting today in Bridgeport, Connecticut talking about child care and also talking about doing about the tobacco legislation, so we are very excited about that visit.
Don't you have, Dr. Varmus, some connection to Yale University?
Dr. VARMUS. I have spoken there. I am a friend of Dr. Kessler's.
Ms. DELAURO. Let me ask a couple of questions. I know you all know this but two-thirds of those diagnosed with ovarian cancer die within five years of diagnosis, yet we still do not have a simple diagnostic test that detects the disease in the early stages.
Last year the NIH devoted $41 million out of an overall budget of $13 billion for ovarian cancer research. If I could ask you how much you plan to spend this year on ovarian cancer research and what progress has been made toward developing a diagnostic test that could detect the disease and help save lives.
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Dr. VARMUS. The anticipated number is $46 million for FY99. But I would emphasize that that number probably does not encompass all the things that are going on that will affect our approach to ovarian cancer—for example, to understand some of the genes that we know to be involved in ovarian cancer: The large attack that is being made through the cancer genome anatomy project, which you will hear more about from Dr. Klausner, has chosen ovarian cancer as one of its targets for development.
NIH AND NASA COLLABORATION
Ms. DELAURO. I look forward to talking with Dr. Klausner when he comes up to talk about a whole range of activities with regard to this disease.
Also I might ask you to talk a little bit about—I know NASA is doing some work in cancer research. I attended a luncheon last year where NASA talked about some of the work that they are doing in basic biology of cancer cells and how they grow, how they don't grow, how we can stop them from growing and, with regard to ovarian cancer, tumors using something that they have called the NASA rotating vessel in order to grow the tumors and monitor their progress.
I would like to know about the collaboration between the NIH and NASA and what you are doing on this issue and other areas.
Dr. VARMUS. We have quite a number of interactions with NASA, most focussed on neurological disorders. We are involved in some of the Neurolab projects. We have been studying balance and hearing and we also have a component of our research that is addressed to similarities between aging and time and space. But Dr. Klausner informs me that we are working with them to develop what is called a bioreactor, in which various types of cells are grown to extremely large numbers for a variety of purposes.
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NIH AND DOE COLLABORATIONS
Ms. DELAURO. I am again interested in those kinds of collaborative efforts because last year I asked about some of the discoveries that were being made with regard to children's brains and when our children learn and what that process is about and how to make some of the leaps to education and Head Start and Early Head Start in the year 2003. Can you talk about that collaborative effort with the Department of Education? Are you working with them on this?
Dr. VARMUS. We do work with them and you will hear from Dr. Alexander from the National Institute of Child Health and Human Development who will testify about some of those things.
We have had some remarkable discoveries just in the last few weeks about the way in which the use of brain imaging can influence our understanding of reading disorders. You may have seen in the paper the pictures of brain images that show the different components of the brain illuminated in normal as opposed to dyslexic children. That gives us a very important focus for further studies of this disorder. And whatever understanding is achieved is, of course, shared with the Department of Education. I think you can get more details of that collaborative arrangement from Dr. Alexander.
Ms. DELAURO. I am aware of Dr. Shaywitz's work.
Dr. VARMUS. Yes. I omitted the fact that that work did come from Yale University. My oversight.
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Ms. DELAURO. I have had the opportunity to hear her speak. What we are going to try to do in the next several weeks is to bring together people from the education field in the district, from superintendents of schools, parents and others to get the benefit of this research, to understand it in some way again, in the effort to take the knowledge that is being developed and move it into an arena for learning and for kids to be able to take advantage or for our teachers to be able to take advantage of research. It is real but to make it real in the classroom or real in doctors' offices, with the work that you are doing.
COLLABORATIONS AMONG FEDERAL AGENICES
Dr. VARMUS. I might just make one more general point about collaboration among federal agencies. Mr. Bonilla referred earlier to my flip cards. Well, I have a couple of flip cards that are full of the interactions that occur between individual NIH Institutes and a wide variety of federal agencies, both within the Public Health Service and outside it. I believe those are extremely useful interactions, and I think in all fields, including education, we are working very productively with other agencies.
Ms. DELAURO. I think that that kind of information is very important to us because the work you do and its applicability, as I said earlier, to doctors' offices, to the classroom, to a practical setting, if you will, is important for us to know that, to make those connections, that this work does not exist for the sake of research alone, which is critically important—don't misunderstand me. I think you know what my sentiments are.
But I think we need to be able to leave this committee and to take these collaborations and be able to explain that to other colleagues, to talk about these efforts.
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EARMARKS
Dr. VARMUS. We are especially proud this year of the very productive interactions we have had with the National Science Foundation, which led in part, among other things, to the development of a new training program in which NSF-sponsored physicists, engineers, and mathematicians will come to the NIH campus to become more involved in biological research.
Ms. DELAURO. Thank you very, very much.
Mr. PORTER. Thank you, Ms. DeLauro.
Dr. Varmus, am I correct that you will also be present when each of the other directors of the institutes testify?
Dr. VARMUS. I am looking forward to it, Mr. Chairman.
Mr. PORTER. Well, we have had a request for a second round, but I think Members will have ample opportunity to ask further questions of Dr. Varmus, if they wish, when he appears during the coming two plus weeks.
While the gentleman from Maryland is here, let me agree that all of us have matters within the bioresearch activities that we feel very strongly about and we not only express that; we encourage, cajole, pressure, for our viewpoints. But what we don't do is direct or earmark. In the final analysis, we believe very strongly that the decisions must be the decisions of NIH and not the decisions of the Congress, and I think that is the right policy and I think the gentleman agrees very strongly with me.
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Dr. Varmus, let me thank you for your excellent testimony and your direct answer to all of our questions. We believe that NIH is truly one of the great treasures of this country. We believe in what you do. We want to do our very best to provide you with the resources you need to do your vital work. The existence of NIH, the wonderful people that it brings to it and the entire biomedical research enterprise of this country makes all of us very proud to be Americans.
Thank you very much for your appearance here today.
Dr. VARMUS. Thank you, Mr. Chairman.
Mr. PORTER. The subcommittee will stand in recess until 10 a.m. tomorrow.
[The following questions were submitted to be answered for the record:]
Offset Folis 95 to 378 Insert here
Wednesday, March 25, 1998.
NATIONAL CANCER INSTITUTE
WITNESSES
DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
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DR. ALAN RABSON, DEPUTY DIRECTOR, NATIONAL CANCER INSTITUTE
DR. HAROLD VARMUS, DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY, BUDGET, DHHS
Mr. PORTER. The subcommittee will come to order. We continue our hearings for the National Institutes of Health with the National Cancer Institute, and we are very pleased to welcome Dr. Richard Klausner, the Director.
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