Chapter 3: Implementation and Early Program Outputs
As reorganization at the National Cancer Institute began to occur the new emphasis on planning began to have an impact, and implementation of efforts toward defined targets began to take place. Added results were beginning to show up in the scientific programs, in early production of resources, and in better coordination of managing the viral oncology activities. The research efforts were concerned largely with methods for finding, identifying, and growing viruses in animal and human tissues. This included the use of electron microscopy (E.M.) for finding various virus particles and of various innovative immunological methods. These findings were correlated with tumor induction in various animal species.
To conduct the research, it was necessary to have large amounts of resources such as antibody-containing sera and other reagents. Several animal species were developed to serve as possible test system hosts for any human tumor viruses that could be isolated, grown and able to produce tumors. These included non-human primates, man’s closest animal relatives. Tissue culture remained a key resource.
Management of the Program continued to move the Institute to greater emphasis on coordinated multi-discipline programmatic research and at the same time more clearly lay out managerial responsibilities and work loads. These modifications will be ongoing for some time in the continuing search for better management.
On May 1, 1963, NCI, in response to a request from Congress, submitted an analysis of the grants, contracts, and intramural research activities for Fiscal Year 1962. Grants totaled $47,607,147 (1746 projects); contracts totaled $27,573,000 (225 contracts); and the intramural programs totaled $14,495,000 (of which $7,185,000 was for reimbursement to NIH for central services). With grants, the largest category was treatment ($15.651 million); for scientific discipline, the largest category was biochemistry ($21.316 million). Virology grants totaled $4.011 million (106 projects). Multidiscipline program project grants totaled $3.567 million (8 projects). With contracts, the CCNSC Program totaled $22.188 million; virus research totaled $2.363 million. Including funds spent on intramural projects, the amounts per Laboratory were nearly equal; however, Pathology, Biochemistry, and Viral Oncology had the largest budgets.
The Fifth Meeting of the Human Cancer Virus Task Force
At this meeting held at the Airlie House Conference Center on May 12-14, 1963, twenty-six investigators from Task Force participating laboratories presented current work underway in their laboratories. The arrangement provided many opportunities for informal interchange of ideas, information, and future possibilities. The informality and common purpose encouraged the reporting of up-to-date activities well before publication. This meeting initiated a series of annual meetings attended by leading investigators in the cancer-viruses field and their staffs. The annual congregations continued for more than a decade and are continued still under the tutelage of Bob Gallo. At the close of the first meeting five informal subcommittees of the Task Force composed of members from the participating laboratories were formed:
J. Horoszewicz (Chairman) RPMI
E. de Harven SKI
A. Moore SKI
R. Manaker LVO-NCI
N. Somerson LID-NIAID
K. Smith Baylor U.
R. Holdenried VRRB-NCI
R. Meyer VRRB-NCI
Laboratory Animals Subcommittee
E Mirand (Chairman) RPMI
F. Rapp Baylor U.
C. Friend SKI
W. Rowe LID-NIAID
P. Sarma LID-NIAID
J. Moloney LVO-NCI
R. Holdenried VRRB-NCI
L. Murphy VRRB-NCI
J. Melnick (Chairman) Baylor U.
C. Southam SKI
H. Coates LID-NIAID
F. Rauscher LVO-NCI
E. Mirand RPMI
R. Holdenried VRRB-NCI
L. Murphy VRRB-NCI
Cell Culture Subcommittee
R. Stevenson (Chairman) VRRB-NCI
S. Stewart LVO-NCI
D. Yohn RPMI
M. Benyesh-Melnick Baylor U.
A. Moore SKI
R Chanock LID-NIAID
R. Meyer VRRB-NCI
Electron Microscope Subcommittee
A. Dalton (Chairman) LVO-NCI
K. Smith Baylor U.
E. de Harven SKI
R. Zeigel LVO-NCI
G. Niwayama RPMI
J. Horoszewicz RPMI
NCI Proposal for Contract Reviews, Program Reviews and Program Planning
On June 21, 1963, the Office of the Associate Director for Program issued for comment a draft of a major document (6 pages plus a 23 page attachment on details): “NCI Proposal for Contract Reviews, Program Reviews and Program Planning.” The document sat forth the philosophy, definitions, operational and organizational guidelines, evaluation and advisory functions, and review of contracts for NCI Programs. The document was accepted as the NCI position and operating policies and practices.
Goals and Objectives of Cancer Research and their Implementation
The Associate Director for Program prepared a 32-page discussion document for the NACC and for the meeting of its Planning Committee on June 22, 1963. The title of the document was “Goals and Objectives of Cancer Research and their Implementation.” In addition to the scientific aspects, the document also covered the NCI organization and management, the program advisory committees, and review of contracts. The Closing Remarks of the document were:
A. The above discussion has presented certain research goals and objectives, analyzed some of the problems involved, made suggestions for expanding research efforts through new devices, and suggested needed changes in legislation and authorities.
B. Pressing problems include:
1. Inducing some of the best investigators to think deeply and seriously about cancer problems and to work on them.
2. Selection of key goals, objectives and important questions needing answers of paramount significance for cancer research.
3. Allocation of resources, which are never unlimited, most effectively to achieve the selected goals and objectives with a minimum expenditure of time and other resources.
4. New legislation as indicated above will be required.
5. These things simply cannot be done without strengthening government staff involved.
6. Who will do the work even if plans, appropriate legislation, and money are available? (Internal NCI document, June 22, 1963).
This document was also discussed at a June 22 meeting of the NCI Scientific Directorate.
Organization and Staffing Changes in the Institute
On June 25, 1963, Dr. Endicott issued a memorandum “Organization and Staffing Changes in the Institute.” Several Institute Associate Director positions were created:
I. The Intramural Research area -- Gordon Zubrod would continue as Director of Intramural Research (and Scientific Director).
A. Associate Director for Laboratory Research - G. Zubrod.
B. Associate Scientific Director for Viral Oncology - R. Bryan.
C. Associate Scientific Director for Experimental Therapeutics - E. Frei.
D. Clinical Director - N. Berlin.
II. The Collaborative Research area -- T. Philip Waalkes would become Associate Director for Collaborative Research.
III. The Field Studies area -- Paul Kotin would become Associate Director for Field Studies.
The Virology Research Resources Branch, with Bob Stevenson as Branch Chief, would be transferred from the Collaborative Research Area to the Field Studies Area. These changes were approved at the NIH and PHS levels. Much of the remainder of 1963 was spent in working out the details of the reorganization of the Institute. Several key memoranda detailing the organizational relationships and procedures for program and contract reviews were issued (by the Institute Director, the Associate Director for Program, and the Chief, Research Contract Operations Branch - this Branch was transferred to the Office of the Director). Extensive Guidelines for review of programs were distributed to members of the Scientific Directorate for action. Since the VRRB had been transferred to the Field Studies Area, contracts for this Area would be reviewed by the Field Studies Task Committee. This group consisted of: Paul Kotin (Associate Director for Field Studies), Chairman; Ian Mitchell (Special Assistant to the Associate Director for Field Studies), Executive Secretary; Bertrand Brill (Chief, Epidemiology Research Branch, PHS Division of Radiological Health); Jerome Cornfield (Biometrics Research Branch, NHI); Walter Heston (Chief, Laboratory of Biology, NCI); Margaret Kelly (Medicine Branch, NCI); Edward Kuff (Laboratory of Biochemistry, NCI); Frank Lundin, Jr. (Head, Special Cancer Studies Section, Epidemiology Branch, NCI); Robert Manaker (Laboratory of Viral Oncology, NCI); Jerry Niswander (Dental Surgeon, Human Genetics Branch, NIDR); Alan Rabson (Pathologic Anatomy Branch, NCI); and Wallace Rowe (Laboratory of Infectious Diseases, NIAID). Review of animal production contracts, however, would be reviewed by the Scientific Directorate, assisted by the Laboratory Animal Committee. This Committee consisted of: Joseph Leiter (Chief, CCNSC, NCI), Chairman; Samuel Poiley (Head, Mammalian Genetics & Animal Production Section, Drug Evaluation Branch, NCI), Executive Secretary; Walter Heston (Chief, Laboratory of Biology, NCI); Robert Holdenreid (Head, Laboratory Animal Section, VRRB, NCI); Michael Klein (Carcinogenesis Studies Branch, NCI); John Murphy (Assistant Administrative Officer, Intramural Research, NCI); and Jane Taylor (Head, Endocrine-Related Tumor Section, Endocrine Evaluation Branch, NCI).
Following discussion at a special meeting of the Scientific Directorate on June 28, 1963, additional discussion was held by the Director, the Director of Intramural Research, and the Associate Director for Program, on the subject of program and contract reviews within NCI. Based on these discussions, the Executive Secretary of the Scientific Directorate sent to the members on July 11, 1963, a memorandum for further discussion at the Directorate meeting of July 15, 1963. Considerable simplification of scope and procedure was effected by elimination of certain features of the June 21, 1963 document. The final document outlining the new contract review procedures, including forms to be used, was sent to staff by the Director, NCI, on September 17, 1963.
Conduct of the Scientific Directorate Meetings
In July 1963 the Chairman of the Scientific Directorate requested suggestions from the members on the conduct of the Directorate meetings. In his role of Executive Secretary of the Directorate, the Associate Director for Program responded to the request on July 12, 1963, with a twelve-page memorandum to the members. Five pages were concerned with the concept of cancer as might be conceived by the members and included a diagram depicting cancer in the individual (conception at other organismic levels was invited). Items in the other seven pages included; 1) The procedural approaches to the conduct of the Directorate meetings; 2) Discussion of drug development approaches; 3) Approach to evaluation of carcinogenesis, especially screening; 4) The use of inbred animals and transplantable tumors versus random-bred animals and autochthonous tumors; 5) Immunology and cancer; implications for future NCI programs; 6) Biochemical genetics and cancer; 7) Experimental embryology; and 8) Endocrinology and cancer.
Early Systems Planning Efforts
It was about this time (September 1963) that the ideas explored on planning by Carl Baker and Lou Carrese over the past year and a half began to crystallize into concrete substance, permitting formulation of planning efforts for the total area of cancer research. In addition to extensive review of the literature on systems planning, this effort included exploration of planning structures, options for goals and objectives statements, and beginning attempts to define the criteria and associated data required to make decisions defined in the plans. Issues on monitoring, accountability and up-dating of plans were also addressed. The areas of viruses and cancer and cancer chemotherapy were examined to test the planning concepts. The concept of the linear array of the steps required in a drug development program was formulated by this stage of planning for chemotherapy (the Leukemia Task Force, Chaired by Gordon Zubrod, had been formed in 1961 and associated with it was enlarged pharmacology research). The NCI was encouraged by the Director of NIH to proceed with this pioneering systems planning effort.
A Contractor-Operated Research Facility
Much of October, November and December was spent by NCI senior staff on developing documentation on establishing a major nearby contractor-managed and contractor-operated research facility responsive to NCI requirements. The concept was briefly discussed with the NACC by the Director, NCI. The need for such a facility grew out of the constraints of shortages of space and positions (in the face of increasing budgets) and the demonstration of effectiveness of such facilities in NASA, Department of Defense, and the Department of Energy. Part of the background included listing planned contract-supported activities, Fiscal Year 1964 (November 12, 1963 memorandum). This listing included activities important for the viruses-cancer area, such as: 1). an estimated $350,000 effort with the Human Cancer Virus Task Force and the VRRB programs for development of viral diagnostic reagents and their packaging and distribution; development of standardized serum and chemically defined tissue culture media made to specifications; additional primate species; and additional human diploid cell strain work for viral transformation, co-carcinogenesis and DNA studies; and 2). an estimated $500,000 for additional ultracentrifuge development with the Oak Ridge National Laboratory (led by Norman Anderson); immunological studies in primates; and murine and human virus studies in germ-free mice. The listing also included potential contractors capable of meeting the complexities of such operations, including not only science and managerial expertise, but also the ability and willingness to take risks. Preliminary discussions with potential contractors were held by Drs. Endicott, Leiter, Coghill, and others. NCI planning called for $200,000 for initiating a contractor-supported activity in the current Fiscal Year. If successful, it might serve as a prototype for similar facilities in other parts of the country. In preparation for discussion of this topic at the January 4, 1964, meeting of the NCI Executive Committee, a 27 page document on the subject (revised based on review at the December 13, 1963, Executive Committee meeting) was distributed on December 31, 1963. The TABLE OF CONTENTS was as follows:
1.1 Rationale for the Facility
1.1.1. High Degree of Flexibility
1.1.2. Problem-solving, Multi-discipline Orientation
1.1.3. Interchange between Biomedical and Physical/Engineering Scientists
1.1.4. Proximity to NIH Campus
1.2 Implications to NCI Staff
1.2.1. Program Planning
1.2.2. Liaison and Coordination
1.2.3. Monitoring and Consultation
1.2.4. Overall Management
2. PROBLEM AREAS AND REQUIREMENTS
NCI REQUIREMENTS AND CANCER RELEVANCE CHART
3. SUMMARY OF INTEGRATED REQUIREMENTS FOR THE TOTAL FACILITY
3.1 NCI Requirements and Facility Capabilities
3.2 Basic Characteristics of the Organization and Staff
3.3 General Outline of Installations Required
3.3.1. Centrifuge and Other Separation Techniques
3.3.4. Pilot Plant Operations
3.3.5. Cell and Organ Preservation
3.3.6. Electron Microscopy
3.4 Fiscal and Contractual Aspects
3.4.1. Real Estate
3.4.2. Physical Plant
3.4.3. General Contractual Arrangement
3.4.4. Subcontracting with Small Business
3.4.5. Personnel Covenant
4. TIME SEQUENCE FOR IMPLEMENTATION
4.1 Basic Document
4.2 Immediate Research
4.3 Formal Invitation
4.4 NCI Administrative Control
4.5 Funding (Internal NCI document, December 13, 1963).
Review of NCI Collaborative Research Programs
The senior staff of the NCI met with the Director, NIH, in mid-1964 to review the NCI Collaborative Research Programs. For this review an outline for discussion was prepared by NCI:
I. Definition of types of activities included under this heading in NCI
A. Research programs which provide services and things to the research community
2. CCNSC (in part)
5. ADP and Communications
B. Large-scale, interinstitutional, interdisciplinary target research programs with strong industrial research overtones
1. Chemotherapy (in part)
2. Leukemia Virology
3. Chemical Carcinogenesis
4. Diagnostic Research
C. Studies of human and animal populations aimed at discovering the etiology, incidence, and natural history of cancer in man and animals (Generally regarded as a normal function of governmental health agencies)
1. Biometry (in part)
3. Carcinogenesis (in part)
4. Virology (in part)
D. Miscellaneous activities funded with contracts because they do not fit conveniently into grants or “in house” operations
1. Support of research in organizations which do not qualify for grants
2. Procurement of services and things
II. Criteria for evaluating collaborative research of the above categories
A. Different categories require different criteria. For example:
1. Resource programs have merit only if they provide resources to activities of merit. To be internally efficient and effective is no great virtue in itself if the final end served is of dubious value.
2. Large-scale, industrial-type research is essential to solve certain types of problems. It cannot be evaluated by comparing it with fundamental research projects in academic institutions.
3. Study of populations is a respectable area of science which can be evaluated with the same criteria as biochemistry or physics.
4. The miscellaneous category has to be evaluated bit-by-bit and defies generalizations.
B. For purposes of this discussion, let us concentrate on large-scale target research and list important criteria.
1. Is the target worthwhile?
2. Is it technically feasible?
3. Are the resources available?
4. Is the plan adequate?
5. Is the management adequate?
6. How fast should one move?
C. Applying these criteria to the NCI programs which deal with diagnosis, treatment, and prevention of cancer, the targets are obviously worthwhile and feasible (as isolated examples show) and resources can be found (as previous experience proves). Now let us deal with points 4, 5, and 6 with each program.
III. Analysis of Chemotherapy
A. The plan. Inherent in the chemotherapy program is the orthodox linear array common to all drug development programs, but several features are importantly different.
1. A number of diseases are included.
2. Satisfactory laboratory model systems are only now beginning to emerge.
3. Drug cures are only beginning to emerge which permit the development of basic principles.
4. The total kill concept and the need for a total re-planning
B. The management
1. Recent losses of key men
2. Low morale
3. Failure in recruitment
4. Need to use intramural talents
5. Need for better support from OD/NIH and higher echelons
C. How fast should one move?
1. Program has been held practically level for some years by agreement of Shannon and Endicott.
2. Wooldridge Committee and other political pressures to cut back.
3. Technical reasons for pushing ahead at full speed.
IV. Analysis of Carcinogenesis
A. The plan. No over-all plan has ever been set forth. Limited segments have been planned elegantly (i.e., Leukemia-Virus Program). Others more sketchily. Great potential here.
B. The management. Excellent and getting better by leaps and bounds.
C. How fast should one move? Kotin says should go from 10 to 50 million dollars in the next three years.
V. Analysis of Diagnostic Research
A. The plan. Planning is not active. Existing plans developed by Nadel not accepted by Berlin. Program has been progressively cut back for five years.
B. The management. With Nadel’s retirement this summer, there will be little left.
C. How fast should one move? Would suggest that this be quietly dropped as a line item in the budget.
VI. Some thoughts on OD/NIH, Collaborative Research and the Wooldridge Committee
A. Director, NIH, and Surgeon General should give strong support to collaborative and intramural research without waiting for more studies.
B. Collaborative programs should not be reviewed (from the standpoint of scientific substance) except in the context of the over-all program of an institute.
C. Reaffirm plans for an annual total review of program by Council.
D. Establish a committee to advise Director, NIH, on total program of NIH.
E. Insist on adequate program review at the working level including internal and external advisors.
F. Retain power of contractor selection as an executive function.
The Diagnostic Research Program would be discontinued as a line item in the budget (Dr. Berlin to write rationale for discontinuing the Program). The virology program in Ghana would be phased out. Dr. Shannon liked the idea that Drs. Zubrod, Baker, and Schepartz and Mr. Carrese would lay out a systems plan for the Chemotherapy Program. He wished to involve the NACC subcommittees more in the program reviews and would establish review groups: 1) chemotherapy; and 2) carcinogenesis (would not include VRRB, Epidemiology or Biometry). Biometry and Epidemiology is not like other parts of Collaborative Research, but do require contract dollars. In the review, the Chemotherapy Program was considered sound. For Phase III clinical trials the single instrument grant would continue to be used; NCI would continue internal control of Phase I and Phase II trials. The Lymphoma and Breast Cancer Task Forces would continue as Prime Contractors. Staff positions requiring both scientific and managerial skills were not adequately appreciated; Drs. Shannon and Mider would meet with such staff members to reassure them.
Request for Release of Bureau of the Budget Reserve NCI Funds for Funding of the Contractor-Operator Facility
The NCI Scientific Directorate and the NACC reviewed a document (January 4, 1964) justifying the establishment of a major special purpose contractor-operated research facility, along with a request to fund the facility with NCI monies that had been put into reserve by the Bureau of the Budget. The NCI then sent the document forward through the appropriate channels. The Director of NIH and the PHS Surgeon General supported the request. Although this March 6, 1964, memorandum pointed out the need for quick action, the reply to the request received by NCI June 15, 1964, stated that “in the Fiscal Year to use the funds and release of reserves was therefore denied.”
Although sizable contracts with several commercial firms were let, it was not until President Nixon announced on October 18, 1971, the conversion of the Fort Detrick Germ Warfare Facility (at Frederick, Maryland) to a Cancer Research Facility that the large contractor-operated facility envisioned in the above document sent forward by Dr. Shannon on March 6, 1964 could become a reality. Immediately prior to the President’s announcement, Drs. Baker, Rauscher, and Zubrod reviewed the status of cancer and cancer research with the President at the Frederick facility. They emphasized the viruses and cancer research. The announcement of the awarding of a $6.8 million contract to Litton Bionetics, Inc. was made on June 23, 1972. Litton had won the contract through competitive bidding. Several parts of the contract related directly to viruses and cancer research. William Payne was the project officer for NCI; Robert Stevenson, formerly Head of the VRRB, was the General Manager for Litton; and James Nance was President of Litton Bionetics, Inc.
Review of NIH by the Wooldridge Committee
In late 1963 President Kennedy asked Dr. Jerome Wiesner, his Science Advisor and Chief of the Office of Science and Technology, to undertake a study to assess the quality of biomedical research conducted and supported by the National Institutes of Health. Dr. Dean Wooldridge was appointed Chairman of a committee assigned the task. Dr. Shannon and the senior OD, NIH staff met with the Office of Science and Technology staff and key members of the Committee on January 9, 1964, and on June 25, 1964, to provide orientation and to answer questions from the Committee. In March 1964 NIH staff spent a significant amount of time in preparing orientation material for the Committee. The Committee gave special emphasis to issues such as the optimal size of NIH, if the budget of NIH was “too large,” and whether the money appropriated for NIH was well spent, especially for the Collaborative Research programs. It was important to produce this orientation material because several members of the Committee were not knowledgeable in the biomedical sciences. In addition to Dean Wooldridge, other Committee members were: Dr. Wiesner (MIT); General James Doolittle (Space Technical Labs, Inc.); Dr. William Houston (Rice University); Dr. George James (Commissioner of Health, New York City); Dr. William McElroy (Johns Hopkins University); Dr. Carl Moore (Washington University); Dr. Quigg Newton (Commonwealth Fund); Dr. Joseph Platt (Harvey Mudd College); Mr. Gwilym Price (Westinghouse Electric and Manufacturing Group); Dr. Wayne Reitz (University of Florida); Dr. Julius Stratton (MIT); and Thomas Watson, Jr. (IBM). Several of the Chairmen of the eleven supporting Panels were biomedical investigators. Two Panels were concerned with administrative and policy matters. NCI produced 85 pages of material on NCI Collaborative research programs plus materials on 119 NCI contracts and staffing charts. NIH produced 310 pages on Collaborative Research programs in six Institutes and in the Division of General Medical Sciences. Fifteen pages dealt with the NCI viruses and cancer programs. Members of the Committee and the Panels also interviewed about 500 grantee investigators from over 30 major institutions, about 50 NIH investigators, and a number of contractors in the collaborative areas. In the Report to the President in February 1965, the Committee gave a favorable review to the grants area and intramural programs. Questions were raised about the Collaborative Research areas. As was usual, the recommendation from the Committee was that NIH needed more advice from committees that had members from outside Government (i.e., from the academic community). In the case of the CCNSC it was recommended that another committee be established to review in further depth the CCNSC (this recommendation led to the review of CCNSC by the Richardson Committee). [It is of interest that NIH has been reviewed by many committees over the years: the Wolverton Committee, 1958; the Bayne-Jones Committee, 1958; the Bane Committee, 1959; the Jones Committee, 1960; the Barber Committee, 1964; the Wooldridge Committee, 1964; the Committee on Heart Disease, Cancer, and Stroke, 1964-1965; the Rogers Committee, 1966; the Ruina Committee, 1966; the Fountain Committee, 1959-1968; and others, in addition to the various Congressional Committees (e.g., the Elliott and Daddario Committees), including the examinations made annually by the Congressional Appropriations Committees.]
NCI Program Review of Clinical Studies, Collaborative Research
The NCI Scientific Directorate undertook an extensive review of cancer clinical studies at its meetings of April 7, 21, and 28, and May 12, 1964. Dr. Waalkes, Associate Director for Collaborative Research, provided a large amount of documentation for the review. This material had been discussed with the Clinical Studies Panel as part of consideration of the analysis and planning for the CCNSC. The Panel consisted of: I.S. Ravdin (University of Pennsylvania), Chairman; Emil Frei, III (NCI); Albert Segaloff (Alton Ochsner Medical Foundation); Bruce Shnider (Georgetown University); Albert Owens, Jr. (Johns Hopkins University); Anthony Curreri (University of Wisconsin); Jesse Steinfeld (University of Southern California); and Lyndon Lee (Veterans Administration). The meetings focused on improving the activities of five categories of twenty-three cooperative groups and the need for additional pharmacology studies. The five categories were: 1) Hematologic Malignancies; 2) Solid Tumors; 3) Hormone-Dependent Tumors; 4) Surgery Adjuvant Studies; and 5) Radiation Studies. Special efforts were needed in defining protocol requirements and information flows. Some investigators objected to the requirements of uniformity imposed by NCI, but uniformity of definition and information handling was (and is) essential for drug development and for analysis and evaluation of the activities of the groups. In addition to $5,843,000 budgeted for programmed grants, the clinical trials effort included $1,020,816 in supporting contracts plus $1,511,030 in transfer funds to the VA, Walter Reed Army Hospital, and the PHS Division of Hospitals. The clinical trials were financed with programmed grants because the HEW lawyers believed (erroneously, it turned out) that this course would keep the Government free of liability lawsuits.
These materials were presented to the NACC when the Chemotherapy Program was reviewed by the Council in March 1964. The NACC supported the plans for the clinical studies. Some members of the NACC were beginning to raise questions about the use of contracts. The NACC membership in 1964 consisted of: Walter Burdette (University of Utah); Lee Clark (M.D. Anderson Hospital); Philip Cohen (University of Wisconsin); George Cooper (St. Joseph College); Charles Evans (University of Washington); Sidney Farber (Harvard Medical School); Abner McGehee Harvey (Johns Hopkins University; Mary Lasker (Albert and Mary Lasker Foundation); Leo Rigler (Cedars of Lebanon Hospital); and Philippe Shubik (Chicago Medical School). Mary Lasker, supported by Sidney Farber and Leo Rigler, wanted the NACC to have the same approval requirements for contracts as for grants. Other Council members did not agree. Anticipating questions from the Council, NCI sent on May 15, 1964, to the Council a four-page document by the Associate Director for Program setting forth the nature of research contracting, the reasons for its use, and review mechanisms. The document pointed out that the NCI, in order to meet its responsibilities to further cancer research, needed to support and engage in the full spectrum of research, with fundamental or exploratory research at one end of the spectrum and developmental research at the other. For the most part, exploratory research depended upon independent investigators conducting self-generating projects. Developmental research was most often part of a broader scope of multidiscipline R&D efforts integrated into a program consisting of many interrelated parts. Grants were most suited for funding projects and contracts for funding programs. Central control was not preferable for exploratory research (grants). The necessity of integrating the components into a program required central control, especially since the input from one contract was at times dependent on the output of other contracts. Several contracts were production contracts for defined mice and other animals, tissue culture cell lines, media, virus preparations, antibody preparations, information collecting and distribution, and so on. Programs required central planning (but not down at the project level). NCI staff conducted exploratory research on an intramural basis, administered the extensive grants activities, and managed the contract activities. The third area involved program planning and integration of science and management expertise. As an aid for planning, the Associate Director for Program created a comprehensive grid showing various scientific and administrative components making up cancer research and which contrasted with ten organismic levels (radiation; atomic; micromolecular; macromolecular; subcellular; cellular; tissue and organ; multicellular individuals; populations; and societies).
As of November 1963, the dollar distribution of contract monies was:
Leukemia Task Force 600,000
Other Leukemia Activities 325,000
Viral Resources and Virus Task Force 2,264,000
Other Virus Activities 2,525,000
Diagnostic Research 1,000,000
Reserve for Expenditure Adjustments 500,000
Unallocated or Bureau of Budget Reserve 4,045,000
NACC Meeting of June 22, 1964
The NCI Director made changes in the Intramural Program and in the Grants and Training area 1963-1964 to utilize senior staff more for broad substantive cancer considerations and less for routine issues. He and the NACC agreed that analogous changes were needed in the conduct of the activities of the Council. It was also agreed that the NACC should move away from so much time spent on individual project applications and give more time and attention to cancer program considerations, including planning. To move in this direction, the Associate Director for Program sent to the Council Members a 32-page document entitled “Goals and Objectives of Cancer Research and their Implementation.” This document dated June 22, 1964, was a discussion document specifically for the Planning Committee, NACC. The Associate Director also sent to the Council members the responses received from the NACC members to Dr. Endicott’s request for their “views in writing on the trends, thrusts, deficiencies and so on regarding cancer research over the next decade.” Two responses had been received. The contrast between the two is interesting. One, from Dr. Philip Cohen, was general and dealt with training needs (physical facilities, job opportunities, and funding support for more trained scientists), and greater dollar support for fundamental research (with less emphasis at NIH for categorical research). He warned that the gap was wide between the accumulated knowledge and the application in the clinic. He thought that all basic problems in biology, including those in cancer, were so complex that they would not be solved by merely continuing to spend more money in the same way as in the past. The other response, from Dr. Charles Evans, set forth objectives, mostly in terms of substantive scientific aspects of cancer problems. He first listed obvious objectives: cause, prevention, cures, treatment of incurable cancer, and determination of means whereby popular acceptance can be achieved for procedures that are known to prevent cancer. Next, he set forth some peripheral goals: define consequences that would follow from the controlling of cancer and make plans for use in cancer research and control of the increasing manpower pool resulting from technological advances. Next, he detailed more specific objectives related to the major goals. He also outlined some recommendations on manpower needs for cancer research and cancer control.
These two examples illustrate two very different approaches to the giving of advice. One focuses on the mechanics of funding with emphasis on basic research support. The other attempts to identify substantive scientific aspects of the problem area and project research needs based on the scientific conceptual schemes. They also illustrate very different attitudes where one view sees the problem as the glass being half-empty and the other as half-full. The former is a pessimistic view that says that we do not know enough to do more than generally support individual scientists. The other, with a more optimistic outlook, suggests that analysis of the situation can lead to selected priorities that form the basis for action. The efforts can be aimed at solving defined problems derived from the selections of priorities. More often than not the advice given to NIH is the former.