and mortality statistics of the United States do compare favorably with those of other highly complex societies. With regard to increased/decreased investment in biomedical research, it should be emphasized that at least 80 to 90 percent of many fundamental scientific discoveries that underlie any specific medical advance are made prior to and without insight into the conceptualization of a specific medical application. Therefore, it is not possible to predict with any degree of accuracy what the effect of either increasing or decreasing the research budget would have on the future health of our population. What is clear, however, is that any budget reduction that markedly reduces the development of knowledge about life processes and the breakdown of these processes will undermine the foundation upon which improvements in prevention, diagnosis, treatment and rehabilitation will ultimately depend. CONSULTANTS Question: The Carter consultant budget for FY 82 for NIH increased by $1.6 million over FY 81 for non-evaluation activities. Why can't you cut back on evaluation studies for which you request $7.6 million? Answer: Section 513 of P.L. 91-296, the Public Health Service Act (42 USC 2996), establishes a set-aside of up to 1% of funds appropriated to any program authorized by the PHS and other related acts for program evaluation. The funds are to be used at the discretion of the Secretary, HHS, for the evaluation of health programs. Up to one-half of the set-aside is made directly available to the individual agency to conduct studies. Each year at the direction of the Assistant Secretary for Planning and Evaluation, OS, and of the Assistant Secretary for Health, PHS, a program of studies. is planned and conducted by the Bureaus, Institutes, and Divisions of the NIH as well as by the Office of the Director, NIH. The proposed evaluation studies are carefully reviewed at the NIH, PHS and Office of the Secretary levels to assure that the studies are needed and are well designed to meet the objectives. Evaluation studies assist in program development and management decision making. Program evaluations involve examination of program structure, function, mechanisms, and output to determine how effectively the program mission is being accomplished and to what extent objectives are being realized through policies, procedures, and activities that have been established. Study of agency-wide mechanisms of support, special areas of emphasis, and the development of evaluation methods and data bases are also essential features of the evaluation program. As the evaluation program is planned for FY 1982, we will assure that only the highest priority studies will be conducted. Those funds not utilized for evaluation studies will be used for the original program purposes. NATIONAL CANCER INSTITUTE STATEMENT OF VINCENT T. DEVITA, JR., DIRECTOR ACCOMPANIED BY: DR. DONALD S. FREDRICKSON, DIRECTOR, NATIONAL INSTITUTES OF HEALTH PHILIP D. AMORUSO, EXECUTIVE OFFICER, ADMINISTRATIVE MANAGEMENT JOHN P. HARTINGER, BUDGET OFFICER NORMAN D. MANSFIELD, DIRECTOR, DIVISION OF FINANCIAL MAN- BUDGET DEPUTY RESEARCH HIGHLIGHTS ASSISTANT SECRETARY, Senator SCHMITT. We will proceed now to the National Cancer Insti tute. Our next witness is Dr. Vincent T. DeVita, Director of the Institute. The Cancer Institute was established in 1937 and is the primary Federal agency charged with leading the Government's war on cancer. Dr. DeVita, we welcome you. In the interests of time, again, we ask that you briefly highlight your opening statement so that we may proceed with questions. If you wish, you may introduce your associates who have not been previously introduced. Dr. DE VITA. Thank you, Mr. Chairman. On my immediate left is John Hartinger, NCI's Budget Officer. Mr. Chairman, I am pleased to have the opportunity to present the program of the Cancer Institute. In the interest of time, I will highlight a few points and devote the remaining time to any questions you want answered. This is the 10th anniversary of the national cancer program, and it is probably worthwhile to strike some contrasts between the state of the art in 1970 and the state of the art in 1981. I am pleased to say that in the four major areas where the Institute supports research-cause and prevention. detection and diagnosis, treatment, and basic cancer biology-there is a striking difference in the state of the art between 1970 and 1981. SHIFTS IN RESEARCH PRIORITIES The Institute made a major shift in its emphasis around 1975 and changed the amount of resources it devoted to cancer prevention. I'd like to just cite some of those figures for you. (313) The backbone of any prevention program is, again, epidemiology. We have increased our efforts in cancer epidemiology in the last 4 years by 100 percent; and in the study of the chemical causation of cancer, by about 45 percent; while diminishing our efforts in seeking a viral cause of cancer over the same time period by 21⁄2 percent. In contrast, the resources devoted to treatment research only went up about 25 percent in these 4 years. So in the last 4 years, there has been a rather striking change in our priorities. There has been good reason for this. We think that if one defines the environment broadly, about 80 percent of all cancers, are related to things that happen in the environment. In 1971, we could only imagine how to prevent cancer. We did not have the information. The switch in the resources supplied by the cancer program has given us a real insight into some of the capabilities we have in preventing cancer. We're quite excited about the prospects of being able to make some headway in this area in the coming years. This year we have a new initiative in the cancer prevention area within the new division established to deal with the applied side of cancer prevention. We're in the process of creating a chemoprevention program, to take advantage of and supply some of the new information. For example, derivatives of vitamin A might be used to prevent cancer. Since to determine this will require a large scale, clinical trial, a chemoprevention program is necessary. Senator SCHMITT. I understand that the vitamin A research has been under your personal supervision; is that correct? Dr. DEVITA. Well, not directly, Mr. Chairman. But I have taken a personal interest in facilitating it. It's taken some very interesting turns in recent years. We have some very impressive epidemiologic data that are consistent in one direction. That is, if one looks at a population of people who do not have cancer-16,000 in one recent study draws serum samples and saves those samples, sometime later we can look at people who develop cancer and compare them to matched controls. The data in all studies I know of point consistently in the direction of showing that those that have higher levels of retinol, vitamin A, in fact, have lower incidences of certain kinds of cancer. Many of these happen to be very common cancers, like lung cancer or colon cancer. This data fits very well with the experimental data developed by the Institute some years ago. These studies looked at the derivatives of vitamin A as a way of preventing cancer in rodents after they've been exposed to a cancer-causing agent. So we're quite excited about the prospects of testing some of the derivatives of vitamin A in clinical trials. These types of trials are logistically very difficult problems to deal with. We have to use large groups of people and follow them over a long period of time, but the trials also provide an opportunity that we have now that we didn't have or didn't even know about during the early 1970's. There are others as well. CANCER PROMOTERS There is some suggestive information about colon cancer, which is a very common killer in this country. The incidence of colon cancer is quite different in the Northeastern United States and the Southern Ünited States. It looks like people who migrate from the North to the South of the United States adopt the incidence of the Southern United States. That is a very important observation, for it implies that, over a relatively short period of time, one can change the frequency that one given population gets colon cancer. This observation fits research data developed on the two-stage process of carcinogenesis, looking at two kinds of cancer-causing agents, initiators and promoters. We feel promoters can be removed from the environment and the incidence of cancer may fall fairly abruptly. So although we don't have good tests for promoters, we know some of the things fall under the category of promoters. Cigarette smoke, for example, appears to behave much in the manner of a promoter, because we know the mortality of doctors in Britain who stopped smoking has dropped over the past decade from lung cancer. There are quite a few opportunities we're now exploring while we search for the exact mechanisms of the causation of cancer. We actually know how some cancer-causing viruses may work, something we also didn't know in the early 1970's. TREATMENT RESEARCH I would like to mention one thing about treatment, Mr. Chairman-my background, after all, is in treatment research. The investment the Institute made in cancer drug development in the 1960's was widely applied in the 1970's. What we're now seeing as a result is a reduction in cancer mortality under the age of 50. I brought some materials along with me I can show you, which are also at your desk. This is a reflection of the widespread application of these new chemotherapy tools. In the mid-1970's, we began to develop what we call adjuvant therapy studies and have applied chemotherapy to breast cancer and colorectal cancer in addition to surgery. In 1974, we reported to this committee that we had a positive result in breast cancer. Now, we have data showing that in premenopausal women national mortality from breast cancer is falling. We also have data from studies in the past year showing a drop in rectal cancer mortality. Although we are making strides, determining the impact of using these therapies together may take years. A study reported in 1974 needs 5 years of validation and another 5 years to apply the results, and 2 or 3 years to accrue the patient population. This takes about 10 to 15 years. It is difficult in the framework of one decade to see it all, but we're beginning to see it in a very pleasing way. |