Buidling 31, Conference Room 10
National Institutes of Health
Bethesda, Maryland
NCAB MEMBERS
Dr. Barbara K. Rimer (Chairperson)
PRESIDENT'S CANCER PANEL
Dr. Harold P. Freeman (Chairperson)
ALTERNATE EX OFFICIO NCAB MEMBERS
Dr. Alison Martin, FDA
MEMBERS, EXECUTIVE COMMITTEE,
NATIONAL CANCER INSTITUTE, NIH
Dr. Richard Klausner, Director, National Cancer Institute
LIAISON REPRESENTATIVES
Dr. John Currie, American Association for Cancer Education, Inc. Dr. Rimer called to order the 98th meeting of the National Cancer Advisory Board (NCAB). She introduced guests representing several cancer education and research associations and institutions as well as Federal agencies involved in cancer-related issues. Dr. Rimer welcomed members of the public and invited them to submit in writing any comments regarding items discussed during the meeting. Comments should be submitted within 10 days of the meeting to Dr. Marvin Kalt, Executive Secretary of the Board.
Dr. Rimer referred to the confirmed meeting dates for 1996, 1997, and 1998, as listed in the agenda, and asked Board members to report any conflicts with future meeting dates as soon as possible. She indicated that 3-day meetings have been scheduled, but meetings are anticipated to last only 2 days. Except for the September 1997 meeting, which starts on a Wednesday because of space constraints, all meetings begin on Monday night with meetings of the subcommittees.
Dr. Rimer called for approval of the minutes of the February 27-28, 1996, meeting. The motion was seconded and the minutes were approved. Dr. Rimer announced that future minutes will be available earlier through e-mail.
Dr. Rimer announced that the meeting agenda was full and asked that all members be in attendance for voting, particularly because the new Board members had not yet been formally appointed. By law, a quorum of Board members—a minimum of 10 appointed members—is required for every vote, whether in open or closed session. Dr. Rimer thanked recently retired NCAB members Dr. Kenneth Chan and Mrs. Marlene Malek for coming to this meeting to help meet the requirement for a quorum.
Dr. Rimer asked that requests to have grant applications discussed during the closed session be given to Dr. Kalt before or during the morning break. She announced that those wishing to follow up on any of the communications received from scientists in the community or on any item identified in the Board books also should contact Dr. Kalt.
Dr. Rimer announced that subcommittee meetings would be held during and following lunch. She then reviewed the list of presentations scheduled for the day's Board meeting.
On behalf of the NCAB, Dr. Rimer recognized and honored Dr. Philip Pizzo for his two decades of service to the National Cancer Institute (NCI). Dr. Rimer praised him as one of the NCI's most gifted and compassionate clinical researchers. She expressed particular gratitude for the collaborative way in which Dr. Pizzo had worked with the Board as a liaison to the Navy Committee. Dr. Pizzo has been Acting Director of the Division of Clinical Sciences (DCS), and he will be leaving the NCI to become physician-in-chief at Children's Hospital of Boston. Dr. Rimer presented Dr. Pizzo with a proclamation, which the Board had approved by acclamation. Dr. Pizzo accepted the proclamation and thanked the Board.
Dr. Rimer introduced Dr. Harold Freeman, Chairperson of the President's Cancer Panel (PCP) to report on recent activities of the Panel.
Dr. Freeman announced that, in his brief remarks, he would be issuing a challenge to the members of the NCAB to assist and to guide the PCP over the next few months. The Panel is about to embark on a series of meetings with research, clinical, academic, pharmaceutical, advocacy, patient, and other concerned groups across the nation to hear first-hand about the impact managed or captivated care is having on the initiation of Phase I clinical trials. Dr. Freeman explained that the Panel had chosen to investigate Phase I trials because the NCI, through the excellent work of Dr. Robert Wittes and Ms. Mary McCabe, is focusing its efforts with the Civilian Health and Medical Plan of the Uniformed Services (CHAMPUS), with the cancer centers, and with clinical trials investigational groups on this issue as it relates to Phase II and III trials.
The Panel's first meeting is scheduled for July 30 in Seattle, Washington, where the Panel hopes to hear from concerned groups and individuals who are experiencing the impact of managed care. Dr. Freeman characterized Seattle as an area that is dominated by health maintenance organizations like the Group Health Association and larger corporate care organizations like Aetna's Northwest Regional Services. He added that Seattle also is the home of the Fred Hutchinson Cancer Center and the University of Washington, both of which are vested in the support of Phase I trials. The remainder of the 1996 meetings are scheduled for September, October, and November and will address concerns about managed care, as well as other issues.
Dr. Freeman stated that the question of Phase I trials affects many Board members immediately, and everyone ultimately, through its impact on initial support from which the nation will derive future treatment and prevention choices. He therefore invited Board members to pose specific questions for the Panel to investigate during the course of the next few months. He also invited the Board to join the Panel members in the investigative process. He asked those wishing to participate to contact Dr. Paul Calabresi, Ms. Frances Visco, himself, or Dr. Maureen Wilson.
In response to Dr. Sigal's question about the outcome of the investigation, Dr. Freeman stated that the Panel would make recommendations after all data had been collected.
Dr. Rimer asked how the Panel planned to publicize the hearings in a city like Seattle, to ensure that people have the opportunity to attend them or to testify. Dr. Freeman acknowledged the validity of her question and stated that past efforts in this regard have not been very good. Although routine notices are sent, Panel meetings often do not attract people locally as they should. Dr. Freeman indicated the need for Panel members and the Executive Secretary to discuss how better to publicize the meetings, because some of the issues addressed are extremely important and the Panel meetings feature presentations by experts that should be heard by a larger public.
Dr. Rimer suggested to Dr. Philip Schein that the Subcommittee on Clinical Investigations might want to take this opportunity to pursue some of its concerns through the hearing mechanism used by Dr. Freeman and the Panel. She suggested that the committee think about specific questions that could be posed to the PCP for consideration during the hearings. Dr. Calabresi agreed, and he suggested that the committee work closely with Dr. Wittes, Ms. McCabe, and the Panel. Dr. Calabresi stated that limiting the coverage in the CHAMPUS agreement to Phase II and Phase III was a choice made by the Department of Defense (DoD) in the negotiations. The NCI is conducting ongoing and productive discussions with other agencies, private insurers, and providers with the ultimate goal of obtaining commitments for the support of all participation in clinical research.
Dr. Freeman agreed and stated that the Panel intends to combine forces. He raised the issue, however, that Phase I/II/III-related limitations of research are not the only effect of managed care on the outcome of cancer care in America. The Panel will combine forces on the Phase I aspect, but will also look at the total effect on the American public with respect to cancer outcome and managed care. Dr. Rimer conveyed the interest of the Board in working with the PCP on this issue, and she asked to be kept informed of the cities where the hearings will be held.
Dr. Freeman emphasized that this effort is of concern to the entire scientific community, in particular, but also to the entire American public. He indicated that all interested individuals in the NCAB and the NCI will be brought in to help plan these meetings.
Dr. Calabresi noted that the meetings will be held in different quadrants of the country, including the west coast, northeast, and south. The belief is that although excellent work has been done in Phase II/Phase III and IV studies, particularly with the CHAMPUS initiative, there will be a gap at the Phase I level, where translational research takes place. Phase I studies should not be interpreted as being just clinical studies, but also as preclinical studies leading to Phase I and Phase I/II studies.
Dr. Rimer expressed interest in the upcoming hearings and thanked Dr. Freeman for his presentation. She introduced Dr. Klausner to present an update on activities in the NCI.
Dr. Klausner reported that the Department of Health and Human Services (DHHS), which includes the NIH and the NCI, is currently operating under a continuing resolution and would continue to do so through the end of FY 1996. The NCI is funded at a level of $2,250,084,000, which is a 5.8 percent increase over the FY 1995 level—AIDS monies are included in this total. Dr. Klausner explained that AIDS funds were not distributed through the Office of AIDS Research (OAR) this year but were given directly to the Institutes as a result of the agreement made early in the year.
Dr. Klausner provided some of the details of the 1997 President's budget, which had been submitted to Congress since the NCAB met in February. The total increase proposed for the NIH was 3.9 percent, or $467M. The NCI's proposed FY 1997 budget represented a 1.3 percent increase over FY 1996. Dr. Klausner explained the apparent disparity in funding increases for the NIH and the NCI. There has been a significant change in policy, determined by the Office of Management and Budget (OMB), based on negotiations concerning the agreed-upon need for the NIH to address the crumbling infrastructure of the NIH Clinical Center. The OMB determined that renovation of the Clinical Center should be paid for completely with funds in the year in which the construction was to be approved. Dr. Klausner noted that the NCI had initially negotiated for multiyear funding, but the decision was made to have all funding available for a major construction project at the time of the approval. Dr. Klausner stated that the actual cost for the Clinical Center is almost $310M and the difference between $310M and the $274M listed in the NCI budget is offset by decreasing the NIH buildings and facilities fund. Without the buildings and facilities funds, the total increase for the NIH research is $193M, or 1.6 percent over the FY 1996 budget. This NIH increase of 1.6 percent contrasts more favorably with the 1.3 percent proposed increase for the NCI.
Dr. Klausner next addressed the distribution of funds among the various funding mechanisms in the President's budget for FY 1997. An increase in the Research Project Grants (RPG) line from $1.02B to $1.06B is proposed. This would represent 46.5 percent of the total NCI budget. The Cancer Centers line would remain flat at $167M in this proposal; however, Dr. Klausner emphasized, the budget process is in early stages. Cancer Centers would maintain the increase that was made in FY 1996; most of the changes made in FY 1996 would be continued.
Dr. Klausner pointed out that the intramural research budget decreased from 18.5 percent of the NCI budget in FY 1995 to 18 percent in FY 1996 and would decrease to 17.5 percent in the budget proposed for FY 1997. Research Management and Support would continue at $100M. He noted the possibility of changes, because of reprogramming that was not completed in time to be incorporated in the recommendations to the President's budget.
Dr. Klausner stated that the description of the intramural research budget contained in the FY 1997 President's budget accurately reflects all contracts and all support received from the Frederick Cancer Research and Development Center (FCRDC). Additional discussion of the intramural research budget was postponed until the response to the Bishop-Calabresi Report scheduled later in the meeting.
Dr. Klausner pointed out that the NCI's actual FY 1996 budget total as shown on the slide did not reflect the fact that the NIH Director, Dr. Harold Varmus, exercised his 1-percent transfer authority and redistributed a total of $25M to the Institutes. The NCI received $10M of that $25M for its successful proposals in cancer genetics and in development of an informatics infrastructure for the National Clinical Trials System. The NCI thus received a net increase of $7M over the original allocation for FY 1996.
Dr. Klausner reviewed the status of the RPG budget line as proposed in the FY 1997 President's budget: noncompeting grants would increase by 290 (7.2 percent increase); competing grants would decrease by 129 (8.8 percent decrease); Small Business Innovation Research (SBIR) grants by law would increase; the total number of grants would increase from 3,444 to 3,605. Dr. Klausner noted that Congressman Porter's hearings in Congress questioned some aspects of the SBIR budget and final word on that appropriation has not been received. Without further budget changes, the R01 percentile funding line—the payline—would drop from the current 23rd percentile to the 21st percentile, and the success rate, calculated to be 29 percent this year, would be 27 percent for FY 1997. By contrast, the R01 payline in FY 1995 was 15 percent. Program project grants (P01) would have a payline at the 31st percentile and begin at a priority score of 140; small research grants (R03) would begin at a priority score of 200.
Dr. Klausner reminded the Board that these figures represented the budget at the beginning of deliberations of the President's proposed budget. The final status of the SBIR and the Small Business Technology Transfer Research (STTR) grants will depend on the deliberations of Congress. Significant changes have been effected in the NCI AIDS budget, which, Dr. Klausner stated, would be described in the scheduled report on progress in the implementation of the Bishop-Calabresi Report. The changes include reprogramming AIDS monies and rethinking how funds are coded.
Dr. Klausner reported that appropriation hearings held since the February NCAB meeting went quite well. Members of the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies were aware of the changes the NCI has undergone and were supportive.
Since February, the first meetings were held of the NCI's two advisory boards—the Board of Scientific Counselors (BSC) for the Intramural Program and the Board of Scientific Advisers (BSA) for the Extramural Program. Dr. Klausner stated that the membership rosters are complete, and the Boards have been chartered. They are reviewing NCI operations, and participating in the planning and implementation of programs. Dr. Klausner deferred further discussion of advisory board activities until the discussion of the NCI's implementation of the Bishop-Calabresi Report.
Dr. Klausner announced that the Bypass Budget has been completed and will be released soon. Staff members throughout the DHHS have responded to the Budget with enthusiasm. DHHS Secretary Shalala has requested that the NCI and DHHS collaborate to ensure that the Bypass Budget undergoes widespread public discussion to clarify the role of the NCI and to show that the budget reflects NCI's strategies for progress against cancer based upon scientific opportunities for discovery. Dr. Klausner thanked members of the NCAB and representatives of extramural organizations for their comments, which had been reviewed and incorporated. He expressed satisfaction with the development process for this year's budget and indicated that it would continue to be a part of the NCI's planning activities.
Director's Review Groups—Dr. Klausner reported that, since February, the BSA-based review groups have continued to make progress. The report of the Cancer Centers Program Review Group will be presented later in the meeting by Dr. Joseph Simone. First meetings were held of the Clinical Trials Review Group, chaired by Dr. James Armitage, and the Prevention Review Group, chaired by Dr. Edward Bresnick. Organization of the Developmental Therapeutics Review Group, co-chaired by Dr. Susan Horowitz and Dr. Stuart Schreiber, and the Cancer Control Review Group, chaired by Dr. David Abrams, is progressing, and the groups are expected to be operating within the next few months.
Also, two Director's Working Groups are being formed, with broad representation from the research community, to operate in an ad hoc capacity when the NCI reaches out to the community for expertise from a wide range of constituents. They will not be charged with producing reports about specific programs; rather, they will help the NCI develop strategies with the scientific community to address critical and pressing issues, some of which might be identified as investment opportunities in the Bypass Budget.
The first working group, which has already met, is the Developmental Diagnostics Working Group, chaired by Drs. Arnold Levine and Eric Lander. Its goal is to help the NCI move into the post-genome world, as it applies to cancer. Three subgroups of this working group will advise on Technology Development and Dissemination, Clinical Resources, and Informatics. The Subgroup on Technology Development will bring together many individuals from industry and academia who are involved in the development of relevant technologies. The Subgroup on Clinical Resources will address such questions as: What do we want and what do we need? How will we deal with tissue banks, DNA banks, etc. so that they are aligned with—rather than hindering—developments in technology? The Subgroup on Informatics will focus on the informatics base needed to deal with the enormous amount of information that will be generated.
The second working group that met is the Cancer Genetics Working Group, chaired by Dr. Alfred Knudson and Dr. Barbara Weber. This group will discuss the NCI on the nature of the national infrastructure that will be needed to facilitate the access of individuals to information about and the actual performance of genetic testing for cancer susceptibility. The question to be addressed will be: How can the NCI facilitate a national infrastructure to provide this access in the context of informed consent and counseling, and at the same time facilitate a research base for what is an increasingly complex and growing problem? Dr. Klausner reported that this group supports the creation of a cancer genetics network, which would be a disseminated informatics and education-based network available throughout the country. The NCI will ask its advisory bodies to consider a NCI-sponsored network that would also involve health care providers and would be a source where individuals could receive information about counseling for genetic susceptibility testing and about the testing itself. The network would be embedded in an extremely simple research base that, in essence, would be a registry contained in a longitudinal observational study. Information in the registry would be rendered anonymous and would be completely protected and confidential. Without such a registry, Dr. Klausner observed, the NCI would not be able to integrate the identification of genetic susceptibility in individuals with the opportunity to address their individual questions and to provide for them the possibility of entering clinical studies and clinical trials.
The Cancer Genetics Working Group has now been divided into three subgroups. The first, chaired by Dr. Kenneth Offit, will help create national protocols with widespread collaboration. The protocols will be used for decision trees about counseling and testing for different predispositions and different syndromes. The second subgroup, chaired by Dr. Kenneth Buetow, is already working on a structure for this interactive, two-way education information and informatics system. The third subgroup, co-chaired by Dr. Judy Garber, Ms. Mary Jo Kahn, and Dr. Reed Pyeritz, will identify the activities of relevant professional societies—through liaisons with these organizations—to create a database for educational materials, to identify what educational materials have to be developed, and to learn to interface those educational materials with the distribution and dissemination system that the NCI will establish through this network.
Organizational Changes—Dr. Klausner announced that Dr. Faye Austin has accepted the position of Director, Division of Cancer Biology (DCB), and that Dr. Joseph Fraumeni is Director, Division of Cancer Epidemiology and Genetics (DCEG). The search for a candidate to replace Dr. Pizzo is in progress, and an offer is expected to be made within the month. Dr. Carmen Allegra has agreed to be Acting Director until the new director is appointed (Dr. Edison Liu, University of North Carolina, has since been named to this position).
Update on Accelerated Executive Review (AER) for Grants—Based on 2 months of experience, the program of Accelerated Executive Review (AER) is "working spectacularly," according to Dr. Klausner. Sixteen applications have been reviewed; 10 have resulted in awards—the majority of these are for patient-oriented research. Dr. Klausner expressed conviction that AER is an experiment that should be continued because it provides a way to deal with the problem created by the payline and the queue for amendment. The percentiles of the grants that have been paid range from 23.5 to 28.2 (as opposed to the current payline of 23). Dr. Klausner concluded that the response from the community has been very positive. Even though applications are coming in at a significant rate, the NCI program staff has been able to process and manage them all. He congratulated the program staff on the extraordinary job they are doing.
NIH Shannon Awards—The NCI has received approval from the NIH for an experimental program of year-round Shannon Awards. These are 2-year, $100,000 awards, of which no more than $20,000 can be allocated for indirect costs. Dr. Klausner reported that the program is working well, and the NCI would like to continue the program after the 1-year experiment ends. Eleven awards have been approved—current estimates are that about 30 will be awarded this year—and the NCI has applied to Dr. Varmus for cost sharing between the NIH and the NCI.
Intramural Program—Dr. Klausner reported that much has happened in the Intramural Program that will be reviewed in a later presentation. He announced that although there are many scientific topics to report on, he would focus on epidemiologic data that have been published or that have emerged from new analysis of the latest Surveillance Epidemiology and End Results (SEER) data. He recognized the work of Dr. Brenda Edwards and her staff in the Cancer Control Research Program, which maintains this national resource and works with the extraordinarily valuable information that comes from it. He reported that Secretary Shalala would be announcing the analysis of 1993 data for breast cancer mortality rates at a press conference later in the day.
The 1993 data show that mortality rates for breast cancer continue to fall. For the first time, a small but significant decrease has been seen in the mortality rates in African-Americans, particularly in young women.
Other interesting information derived from analysis of 1993 SEER data includes a decline of about 11 percent in prostate cancer incidence in white men. In African-American men, the incidence continued to increase, but the size of the increase was significantly lower. It is assumed that these results reflect a saturation of incidence due to PSA testing.
Dr. Klausner announced the release by the NCI of a very important SEER monograph entitled Racial/Ethnic Patterns of Cancer Incidence in the United States: 1988-1992. In the monograph, 11 ethnic and racial groups are analyzed in terms of the incidence of and mortality from all cancers, as well as by specific sites. Dr. Klausner noted that this monograph promises to be a valuable resource in identifying research questions that the NCI will need to ask. He announced that an Office for Special Populations will soon be established in the Office of the Director and that he will be
appointing an associate director to oversee that office and help in designing a research agenda aimed at special populations and underserved minorities.
In another action since February, the NCI has established an office to deal with survivorship issues, both short- and long-range, and Dr. Anna Meadows has been appointed to oversee that office. Dr. Meadows, Chair of Oncology at Children's Hospital of Pennsylvania, has considerable interest and expertise in this area, particularly the issue of late effects of treatment and second cancers in childhood. Dr. Klausner cited the growing need for a research agenda concerning the many medical, social, psychosocial, and epidemiologic issues that face cancer survivors, because of the increasing number of long-term survivors after the original diagnosis of cancer. As a first order-of-business, a working group will be convened to solicit advice from the extramural community about creating a research agenda across the Institute for the issue of cancer survivorship.
Mammography Workshop—Dr. Klausner announced that the NCI plans a workshop on mammography in the fall. The impetus for this workshop was the presentation at a meeting in Sweden of recent data from five trials in Sweden, as well as updated analyses from other trials, specifically looking at the issue of mammography screening in women from 40 to 49 years of age. Dr. Klausner commented that the NCI is interested in looking at the Swedish data in the context of peer review. He announced that he has invited the Swedish investigators to submit their work in an accelerated fashion to the Journal of the National Cancer Institute. The NCI workshop in the fall will involve the Swedish investigators, and the data, if not yet published, will be made available to all participants. Both current and complete evidence on many issues related to mammography, including mammography screening in women below the age of 50, will be examined.
A steering committee has been assembled to define the workshop goals as well as research questions and evaluation issues, and to ensure that this workshop has broad participation from individuals with many perspectives. The committee includes Dr. Laszlo Tabar, Swedish investigator from one of the five studies; Dr. Robert Smith, American Cancer Society; Dr. Gillian Newstead, New York University; Ms. Amy Langer, National Alliance of Breast Cancer; Dr. Barbara Rimer, Duke University; Dr. Sam Shapiro, Johns Hopkins University; Dr. Douglas Kamerow, Agency for Health Care Policy and Research (AHCPR); Dr. Edward Sickles and Dr. Lawrence Bassett, American Association for Cancer Research (AACR); and Drs. Barnett Kramer, Edward Sondik, Leslie Ford, Philip Prorok, and Richard Klausner, NCI. Dr. Klausner noted that conclusions presented at the meeting from all of the Swedish studies demonstrated a 23 percent reduction in mortality that was statistically significant. He expressed hope that the data will hold up to rigorous analysis and peer review.
Dr. Day asked if the SEER data had been analyzed to determine reasons for the change in breast cancer incidence and mortality. Dr. Klausner answered that the NCI is reporting only the changes at this time; the NCI has no clear data readily available to explain these changes. He observed that the drop in mortality is seen not only in the United State but also in Canada and the United Kingdom—in the United Kingdom, the drop is about 12 percent. The changes begin about 1990, and that date is consistent with an effect of altered medical intervention, particularly, treatment. Dr. Klausner maintained that determining to what extent these decreases are due to early detection, early diagnosis, better treatment, or different combinations of these is going to be difficult. He asked Dr. Edwards to comment. Dr. Edwards added that her staff have been looking for explanations. The evidence, as far as can be seen, can vary by different age groups, and there are multiple explanations. Dr. Schein commented that concern has been expressed in the Bishop-Calabresi Report about the extent to which the total NCI budget is supported by AIDS research. He asked if the NCI had any contingency plans for phasing out the AIDS program and maintaining the financial integrity of the Institute in the process. Dr. Klausner responded that the NCI has shifted, in 9 months, from 16 percent of the total AIDS budget in the RPG pool to 47 percent. A system has been created for coding what is AIDS, what is AIDS-related, and what is fundamental to understanding AIDS. The NCI has recoded its entire AIDS research portfolio—including intramural research—according to the new classification system.
Dr. Klausner expressed the view that, based on the Levine Report, which clearly defines priorities and approaches to AIDS, the NCI will continue to, play an important role in AIDS research. A major focus for the NCI is AIDS malignancies, which complicate 30 percent of AIDS cases. Moreover, AIDS is the setting for a significant percentage of total cancer incidence, at least in men below age 55, and an important confluence exists between the interests of NCI and the interests and needs of the AIDS Program in terms of virology and human immunology.
Dr. Bishop asked whether the NCI's funding would be affected if Representative Porter's attitude prevailed. Dr. Klausner expressed the opinion that there would be little effect. Dr. Klausner reported, a broad-based group called the AIDS Malignancy Working Group, chaired by Dr. Ellen Feigal, has been instituted. The working group has met and has been advising the NCI on a long-range research program for AIDS malignancies.
Dr. Goldson commended the NCAB's national conference in January on recruitment and retention of minorities to clinical trials. He expressed the opinion that the January conference and regional programs that are being planned will dovetail with the SEER monograph on racial and ethnic patterns of cancer in the United States. The monograph will assist the Board in identifying high-risk areas and forming protocols that will help these groups. He noted that thousands of lives would be saved if all that is accomplished is an increase in black survivorship to match white survivorship. He stated that the Board was moving in the right direction, and that its actions will be a help in the community and affect the way the Board is viewed.
Dr. Rimer thanked Dr. Goldson for his commendation and Dr. Klausner for his presentation. She introduced Ms. Dorothy Tisevich, NCI Legislative Liaison, to present the legislative update.
Ms. Tisevich reported that the number of departing Congressional members continues to increase to about 13 departing senators and more than 40 departing congresspersons. The result of these changes is a more junior makeup of both the House and the Senate, significant turnovers in members and staff, and education on an ongoing basis for new members of the Congress.
Dr. Klausner had several opportunities to meet with members of committees important to the NCI; these meetings focused generally on discussions of the changes at the NCI, the new Bypass Budget approach, and scientific opportunities. One important hearing was held on April 24 before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, chaired by Representative John Porter (R-IL). Several questions asked during the hearing focused on issues that had been raised during preliminary visits: the changes taking place at the NCI, the funds shifted into research project grants, and emerging areas of scientific opportunity.
Dr. Klausner testified as part of the panel on cancer and genetics during a reauthorization hearing before Senator Nancy Kassebaum (R-KS), which was held on March 7. Concern about potential abuses of genetic information was prevalent. A copy of Dr. Klausner's testimony before the committee was provided to the Board.
On May 14, Congressman Porter (R-IL) and several members of the subcommittee and staff were scheduled for a brief visit to the NIH. A hearing featuring a panel of Nobel Laureates was scheduled in the afternoon to gather further testimony on emerging areas of science and the role of the NIH in supporting this research.
The Senate appropriation hearing for the NIH was scheduled for May 23.
Ms. Tisevich briefly mentioned several other issues. At this time, the reauthorization bill for the NIH has not been introduced. Genetic information continues to be an item of great interest, and legislation on health insurance reform was recently passed in both the House and Senate.
Ms. Tisevich reported that, although it is unlikely that comprehensive health care reform legislation will be passed during this Congress, the bill that has passed and is waiting for conference action establishes some steps toward access to care by individuals and would possibly—in the House version—allow for medical insurance accounts that would be tax free.
Ms. Tisevich noted that the Women's Health Equity Act has been introduced in several past Congresses. This is an omnibus bill that includes several pieces of legislation related to women's health. On March 27, Representative Louise Slaughter (D-NY) introduced the Women's Health Equity Act of 1996. This bill is a compilation of 36 separate pieces of legislation that address issues related to areas of interest to women's health, including breast cancer research, employment opportunities for women scientists, cardiovascular disease research, ovarian cancer research, and many others. She noted that experience in past years has shown that the omnibus bill may not be enacted, but individual pieces of legislation, particularly authorizing legislation, often are pulled out and passed separately.
Ms. Tisevich reported that the National Technology Transfer and Advancement Act of 1995 has been passed and signed into law. This legislation addresses several changes in technology transfer activities at the NIH. One provision in the area of reassignment of patent rights now permits the government to reassign the title to patent applications back to the inventor if the government decides to discontinue patent prosecution and otherwise not pursue commercialization. A second provision increases the royalty cap from $100,000 to $150,000 for earnings to individuals on royalties. In a third provision, the use of the license royalty revenue by the government has been expanded. In a fourth provision, unused royalty revenues may be maintained for 2 fiscal years. Previously and until the bill passed, all unused royalty revenue was to be returned to the Treasury after 1 full year. Ms. Tisevich commented that this provision permits the NIH much greater flexibility by making royalty funds available for an additional year.
Dr. Rimer asked if anything had been added to the Kennedy-Kassebaum bill that would cause President Clinton to veto it. Ms. Tisevich indicated that medical trust fund issues have been a topic of much discussion and conference deliberations are under way.
Referring to Clinical Center construction costs, Dr. Sigal asked whether the law required that these funds be written off in 1 year. Ms. Tisevich stated her understanding that a budget request is required to provide for all construction costs at once. Dr. Sigal asked if Ms. Tisevich had any information on how the Senate and House appropriations for the NIH would come out in this regard. Ms. Tisevich referred Dr. Sigal to Dr. Klausner's earlier report that the President's budget, as proposed, is a starting point for congressional deliberation. Dr. Klausner explained that the requirement to provide for all construction costs in 1 year is OMB policy. The President's budget reflects a decision made by OMB in negotiations with the DHHS and Dr. Varmus. The original plan was for an appropriation spread over 4 years. Dr. Sigal suggested that there might be some flexibility or opportunity for discussion if the requirement is not a law.
In response to a question from Dr. Sigal, Ms. Tisevich noted that the Harkin-Hatfield bill has not received much attention recently, and its status is unknown.
Dr. Rimer opened the floor for identification of items to be discussed at the second new business session on the following day. She also called for draft resolutions or items of special public concern that need to be brought before the Board.
Dr. Rimer suggested as an agenda item the request from the Center for Health Advancement regarding support for tobacco counseling as a Health Plan Employer Data and Information Set (HEDIS) indicator; information on this request was included in a packet mailed earlier to all Board members. She expressed the view that this item presents the Board with an opportunity to use its imprimatur on an action that changes the way medicine is practiced in managed care organizations.
Dr. Rimer then introduced Dr. Joseph Bertino, Program Chairman for Molecular Pharmacology and Therapeutics, Memorial Sloan-Kettering Cancer Center, and immediate past president of the AACR to discuss recent events and future plans of the AACR.
Dr. Bertino stated that he finished his term as president of the AACR as of the 87th annual meeting held in Washington, D.C., during the previous week. He characterized the AACR as a dynamic and vibrant society, which has grown in membership at an annual rate of about 10 percent for the last 6 or 7 years. He announced that he would report on some AACR activities and plans for the future.
Dr. Bertino explained that the AACR currently has 11,300 members. The AACR mission is to foster research in cancer and to contribute to the understanding of cancer etiology, diagnosis, treatment, and prevention.
The AACR publishes four journals ranging from epidemiology to clinical research, with the flagship journal being Cancer Research. The AACR also holds annual meetings and small, focused special conferences. The 87th annual meeting held in May attracted 7,800 participants. Six to eight small focused special conferences are held each year. Public education, under the leadership of the Public Education Committee; government and media relations; science education and training programs for young investigators; and international outreach all are important activities of the AACR.
Dr. Bertino described AACR's scientific scope as unique in that it bridges the gap between the laboratory and the clinic. Membership includes scientists, both M.D.s and Ph.D.s, who are expert in both basic and clinical research, epidemiology, prevention, and especially translational research.
Having completed this brief background summary, Dr. Bertino reported on the status of AACR activities over the past year and outlined new initiatives that are planned for early implementation. Dr. Bertino reviewed the focuses of major AACR initiatives undertaken during the last year of his presidency: (1) strengthening the clinical research programs in the AACR; (2) providing training programs and opportunities for young investigators; (3) promoting the professional advancement of women and minorities in cancer and biomedical research; (4) collaborating with relevant scientific societies in the United States and abroad; (5) introducing new electronic media; (6) enhancing communication and collaborations with industry, in part by forming an Industry Advisory Council; (7) emphasizing public education and government relations; (8) enhancing media relations as a mechanism for increasing grassroots support for cancer research among the lay public; and (9) developing a strategic plan for the AACR.
A particular interest in the AACR has been to strengthen clinical programs, emphasizing translation from research to the bedside. A Clinical Research Committee has been organized to oversee the very active clinical programs of AACR. As noted previously, clinical presentations at the AACR annual meeting have increased, and special conferences now include clinical and translational topics. In this regard, Dr. Bertino noted, the conference on prostate cancer, chaired by Dr. Donald Coffey, proved to be one of the most exciting and productive conferences held by AACR during the year.
Another initiative in 1995-1996 was institution of a new award for clinical research accomplishment, entitled the Joseph H. Burchenal Award, which is sponsored by Bristol-Myers Squibb. The first recipient was Dr. James Armitage, current president of the America Society of Clinical Oncology (ASCO). Dr. Bertino stated that AACR has worked to incorporate clinical research into the public education agenda, and one outcome of that effort is active collaboration with ASCO on two annual events. One jointly sponsored event is a Clinical Methods Summer Workshop, which will be useful for training young investigators to understand methodology in clinical research. In the second collaboration, a series of annual special conferences is planned to explore the basic and clinical aspects of one organ-specific topic each year.
Dr. Bertino listed training programs and opportunities initiated by the AACR for young investigators. Under a new program of research fellowships, three awards have been made during the past year to young investigators. AACR has an annual Gertrude Elion Cancer Research Award for junior faculty, which is supported by the Burroughs-Wellcome Glaxo Company. AACR increased its level of support for awards to young scholars for travel to the annual meeting and funding of more than $75,000 is now allocated for this program. Another new opportunity for young investigators is the recently instituted Associate Member Council, composed of young associate members and charged with advising the board of directors on the needs of young investigators.
Dr. Bertino reported that AACR training programs include educational sessions at the annual meetings and summer workshops. In addition to the workshop on Methods in Clinical Cancer Research, two other summer workshops over the past several years were Histopathobiology of Neoplasia and Molecular Biology in Clinical Oncology. Another committee, chaired by Dr. Michael Gottesman, is attempting to develop science education programs to attract high school and undergraduate students to careers in cancer and biomedical research. AACR also sponsors programs to increase professional advancement opportunities for women and minorities in cancer research.
Dr. Bertino announced that AACR has moved into the electronic age with the introduction of Cancer Research on CD-ROM this past year. In addition, AACR's new World Wide Web site has been launched and has attracted much attention (HTTP://WWW.AACR.org).
Dr. Bertino outlined public education initiatives that have been a major focus of recent AACR activities. These include: AACR Public Education Committee, chaired by Dr. Anna Barker; a network of state legislative committees that deals with the individual legislative bodies; public policy sessions at the annual meeting; development of progress statements with a disease orientation as information resources for lay advocates and educational resources for legislators; testimony before the House and Senate Appropriations Subcommittees each year; links with survivor groups through which leaders of the groups give presentations at AACR meetings (e.g., Ms. Francis Visco and Ms. Ellen Stovall); membership in the National Coalition for Cancer Research and the Food and Drug Administration (FDA) Council; celebration of the 25th anniversary of the National Cancer Act at the 1996 annual meeting; and input into the format and content of the Bypass Budget.
Dr. Bertino reviewed events that were part of the celebration of the 25th anniversary of the National Cancer Act during the 1996 annual meeting in May: a congressional briefing on the value of cancer research as an investment opportunity, which was attended by more than 100 congressional aides and associates; more than 25 visits by AACR delegates to members of Congress; a Contact Congress booth, where more than 1,000 letters supporting cancer research were generated; a speech by Congressman James Moran (D-VA) at the plenary session; and a congressional reception on Capitol Hill highlighting the presentation of public service awards to Senators Mark Hatfield (R-OR) and Tom Harkin (D-IA), and Congressman John Porter (R-IL).
On behalf of the AACR, Dr. Bertino expressed approval of the 1997-1998 Bypass Budget, and he congratulated Dr. Klausner and his associates for preparing a document that meets the special challenge of informing the public, Congress, and the Administration about the value of and opportunities for cancer research, as well as the resources needed to achieve the goals of the National Cancer Program.
Dr. Bertino stated that AACR—as part of its public policy agenda—will continue to press for funding for cancer and biomedical research, support legislation for revitalization of the National Cancer Act, support the Hatfield-Harkin Health Research Fund (a major priority in 1996-1997), support the Clinical Research Act, promote FDA changes that will increase the availability of new and more effective cancer therapies to the population, and continue to be involved in the translation of genetic research results to the clinical arena—a major priority.
To implement its public policy agenda, Dr. Bertino noted, AACR has developed a strategic plan with the objectives of increasing AACR's leadership role in fostering cancer research through its own scientific programs and on a national level; using the expertise and broad scientific perspective of the membership to identify national scientific priorities in cancer research; developing a proactive public education strategy in support of these scientific priorities; and strengthening communication with AACR members, lay public, Congress, and the NCI with respect to cancer research issues and policies. Dr. Bertino expressed satisfaction that Dr. Klausner has used AACR membership and expertise widely in the NCI's committees and programs.
Dr. Rimer commended AACR activities related to educating the public about the need to support science at all levels. She noted that this has been the theme of many other NIH Advisory Councils and is a very important function. Dr. Klausner voiced approval of the sense of accomplishment, enthusiasm, and optimism that pervaded the annual meeting, as well as of the number of young people who attended.
Dr. Rimer announced that Dr. Klausner's summons to a meeting at the White House necessitated a change in the timing of the executive session and subcommittee meetings. The executive session was rescheduled to begin at 12:15 p.m., followed by subcommittee meetings.
Dr. Rimer introduced Dr. Joseph Simone, Medical Director, Hunterman Cancer Foundation and Institute, University of Utah, to present a progress report on the Cancer Centers Working Group.
Dr. Simone, Chair, Cancer Centers Working Group, reported that this was the first of the Director's Review Groups convened by Dr. Klausner and that several meetings have been held. He briefly described the progress made by the Working Group. Dr. Simone stated that Dr. Klausner emphasized, in his charge to the Group, that the NCI function is fundamentally discovery and that each working group should consider potential changes and favor substance over precedent and principle over process. Dr. Simone listed the names and affiliations of Group members and noted that a list with addresses would be provided by Dr. Paulette Gray, who is Executive Secretary of the Group.
Dr. Simone explained how the Working Group viewed its charge from Dr. Klausner, who had asked the Group to consider the following issues: What should cancer centers look like? What should their structure be? What can they achieve? What can they not achieve? What should they not be engaged in? How is it best to evaluate the Centers? He explained that the Cancer Centers Program is peculiar among research programs in that it is intended and was developed historically to provide infrastructure for research, not to provide direct funds for research. Thus, it supports various shared resources within an institution and a variety of functions. One of the dilemmas for committees reviewing cancer centers is the charge to review not the science, but rather how these resources are shared, and effectively how they are used. Because this is an almost impossible task, the Working Group is considering the issue of how best to fund these cancer centers based on the evaluation of the review committees.
Dr. Simone stated that the Working Group received many comments from the extramural community addressing the issue of flexibility and accountability. Dr. Simone referred to the report on general principles for cancer centers produced by the Institute of Medicine (IOM) some years ago, which the Working Group has consulted. He noted that the Working Group has been charged with producing a more focused evaluation, with considerably more detail, than that of the IOM, as well as with considering the question of new initiatives and funding.
Dr. Simone presented the five basic areas that constitute the framework of this review. The first area involves considering what the goals should be for the individual centers and for the NCI Centers Program as a whole. Related questions are: How should the Centers Program be viewed? How should it be evaluated programmatically overall?
The second area deals with the structure and function of the three types of centers. Currently, comprehensive centers have programs in the areas of basic science, clinical research, and population-based research; clinical centers have both basic science and clinical research; and basic science centers conduct only basic science research. Related questions include: Is this the right mix? Are these the right designations for cancer centers? What is needed in the armamentaria of the cancer centers? The NCI program has approximately 55 cancer centers—about 12 are basic science centers; about 26 are comprehensive centers; and the remainder are clinical cancer centers.
The third area of the Working Group review focuses on the guidelines, review criteria, and process of review. Dr. Simone noted that these are some of the major issues raised in the testimony received from people in cancer centers and the Group is spending considerable time discussing them. A key question deals with how to review an organization for productivity if the science is not being formally reviewed.
The fourth area focuses on distribution of the cancer centers' funding. The Working Group is looking at the whole area of how funds might be applied, keeping in mind that flexibility cannot be so great that there is no way to measure productivity.
Dr. Simone stated that the fifth area of discussion—that of centers in relation to regional and national resources—has been the most difficult. He gave the example of tying these organizations together with sophisticated informatics and sharing perhaps very expensive resources like tissue and organ banks.
Dr. Simone stated that the Group has met several times and has reviewed extensive reports from the NCI cancer centers staff, presentations from a variety of cancer center directors and interested parties, and communications from a number of people who were invited to comment. The
information is now being collated and organized. Dr. Simone anticipates a few more monthly meetings before the draft report can be formulated.
Dr. Rimer stated that she had received calls and letters from people in the cancer prevention and control community who are concerned that cancer prevention and control is not adequately represented on the Group. She asked Dr. Simone to comment. Dr. Simone gave assurance that the Working Group is cognizant of this and is paying much attention to cancer prevention and control. He pointed out that several members of the Group have a cancer prevention and control orientation, and he stated that the Group has made it known that comments continue to be welcomed.
Dr. Bishop asked Dr. Rimer whether the source of this concern is inadequate representation on the Working Group for research on prevention and control or for implementation of prevention and control measures. He explained that this gets to the issue of whether the centers, in the past, have been expected to go beyond discovery. Dr. Rimer presumed that the concern was about the research mission, and that the Group lacks sufficient appreciation of the role of cancer prevention and control research as an inherent part of cancer centers. Dr. Simone added that the Group is sensitive to this issue, and that discussion has focused on whether cancer centers should exist that do not have a mandate for population-based research. An issue that has not been resolved and is still open to discussion is whether there should be only two kinds of centers—those engaged in the spectrum of cancer research, including population-based research, and those focused on a single area.
Dr. Chan asked for clarification of regional expectations with respect to community outreach and whether the Working Group sees the need to look into minority involvement. Dr. Simone stated that the issue of regional expectations for a cancer center is very complex, because of the differences in geography and the nature of the institutions. An institution like Duke University, for example, which is located in a low-population area, has a different agenda or different possibilities than a cancer center based in New York City or Los Angeles. All comprehensive cancer centers have community outreach programs as part of the requirement for comprehensiveness, and many of the clinical cancer centers also have outreach programs—although they may not have funded research in those areas. The question is whether the existence of community outreach activity in the centers should be formulated into some kind of general policy. Dr. Simone noted that scientists in the basic centers communicate internationally so their physical location is less of an issue. In response to Dr. Chan's question about minority issues, Dr. Simone explained that the Group is sensitive to the problem of reaching minority patients. Some cancer centers succeed and others have difficulty engaging minority populations in cancer research programs in their region.
Dr. Freeman asked whether applied research is a major element being considered by the Working Group, particularly because research, broadly defined, extends from basic to applied. He acknowledged the difficulty in defining research, but voiced his opinion that research that will affect people directly must be addressed. Dr. Simone stated that without question the Group is sensitive to this issue. He pointed out that the Group is broad based, and many are pragmatists with respect to meeting both the needs of patients who enter their institutions and the needs of the community. The centers have difficulty in trying to encompass everything in the spectrum of research. The Group believes that, although some institutions cannot excel at everything, all have an obligation in applied research areas. Dr. Simone noted that virtually all of the cancer centers are engaged in some type of applied research and are uniquely placed and qualified to engage in that kind of activity, because they have a broad charge in the community.
Dr. Freeman asked Dr. Klausner if, at another level (perhaps not the cancer center level), there is still a concern that investigators must study real people in communities. He expressed the belief that the NCI, NCAB, and the PCP have a moral responsibility to try to influence research in that area. Dr. Freeman urged that, along with the discussion about discovery and the NCI as a discovery institution, the NCI's concern that the ultimate effect the NCI must have is on the American public should not diminish.
Dr. Klausner responded that the areas comprising cancer centers, as defined by NCI funding, are parts of large institutions. When defining goals for cancer centers, the NCI must ensure criteria are established to put the limited resources to the best possible use, so that they will have potential for larger effects. Dr. Klausner added that the NCI recognizes all things cannot be accomplished with one approach or one institution, but the NCI must ensure that what is accomplished is of high quality and that the accomplishments can be integrated into and amplified by other activities. He expressed concern that continuing to demand more than is doable and placing those demands on every NCI program results in dissociation from the scale of NCI's resources. Dr. Klausner noted that the Working Group is struggling to strike a balance in this difficult problem, for which there is no perfect solution.
Dr. Freeman stated that, at a certain point in the process, discovery must be transcended and transformed into real meaning for real people. Although it could be argued that this is not the cancer centers' responsibility, at some level, whether it is at the NCI level or that of the PCP, influence must be brought to bear on the total effort that benefits the public with respect to cancer. Dr. Freeman expressed concern that the NCI should continue to do everything possible for all people with what is already known. Dr. Rimer thanked Dr. Freeman and noted that the Board shared his concern.
Dr. Schein noted that one of the Working Group's agenda items relates to managed care, particularly as it will affect cancer centers in their fulfillment of the overall mission, which is to deliver not only new but clinical scientific information to the community. He referred to the concern that free-standing cancer centers might look increasingly too expensive to third-party payers—despite the fact that they have an important clinical research mission for the country—and that the clinical programs in some centers may have to be phased out. Dr. Schein asked what kind of response the Working Group is preparing and what type of recommendations will be proposed to maintain at least the current level of clinical investigation at these centers.
Dr. Simone stated that this issue was one of the first raised at the initial meeting, and he agreed that the problem differs for the categorical cancer centers, which are very specialized in cancer-related activities, and the university-based matrix centers, which have a broad spectrum of patient care activities. He pointed out that both types have problems, depending on their local environment, and that their access to patients is clearly being threatened and reduced. Many kinds of mergers have been discussed, out of fear that clinical programs may not be sustainable at their current level. Beds are closing, and the critical mass that is required in certain kinds of clinical programs is reaching a crisis level in some areas. Dr. Simone gave assurance that the Working Group is aware of the situation and will be addressing the questions, but he speculated about whether the Group had any more intelligence as to what to advise in this area than anybody else. He noted that the Group met with Dr. Wittes and his staff about the CHAMPUS negotiations and discussed whether those negotiations could be extended.
Dr. Correa noted that the benefits of science are not reaching society to the extent that they could, and he suggested that the Board consider whether this perception is well founded. He suggested that, because the NCI is a research institution, perhaps the way to address this perception in a research environment is by asking why the benefits of science are not reaching society. He voiced his opinion that the Institute is somewhat weak in behavioral research, and if behavioral research is not in the charter of the NCI, then perhaps it should be stated. He pointed out that although the basic, clinical, and epidemiologic science may have a behavioral component, behavioral research does not have its own identity.
Dr. Klausner agreed that behavioral research should be on the NCI agenda and should be incorporated into the NCI planning and policymaking process. For this reason, Dr. Klausner stated, one of the five major review groups—the Cancer Control Working Group—will be charged with advising the Institute on mechanisms and priorities in the area of cancer control and on long-range problems in psychosocial and biobehavioral research. Dr. David Abrams, a behavioral scientist, is chairing that committee. In this regard, Dr. Rimer mentioned that Mrs. Malek would report later on an April 1996 meeting that focused on making recommendations in the area of behavioral research. Dr. Rimer noted that the Board has an important window now to strengthen this whole area.
Dr. Calabresi observed that many of the concerns expressed by the Board relate to the interface of science and research discovery with application to the community and people. He seconded Dr. Schein's question about the Working Group's recommendations to deal with the impact of managed care because of the danger that major breast cancer centers will become isolated from the primary care networks that affect a variety of patients and people. Dr. Calabresi pointed out that the fourth overarching recommendation in the Subcommittee to Evaluate the National Cancer Act Program (SENCAP) Report stressed many of the points mentioned by Dr. Chan and Dr. Correa. A related question would be: Is there any opportunity to form networks of cancer centers? Because it has been noted that some centers specialize in different areas, Dr. Calabresi suggested that encouraging cancer centers to collaborate and providing incentives for those that work together in a network would allow research results to be applied more rapidly to a larger and more diffuse population.
In response, Dr. Simone contended that cancer care is a local issue. Although cooperation could be achieved at the informational level, at the research level, or even at the resource level, having an impact on patient care is a local regional issue. He emphasized the importance of finding ways for existing cancer centers, or possibly new centers, to develop their own networks so that they can touch people as broadly as possible where they are located. He pointed out that the centers know best what the issues are, the particular mix of their populations, and their own capabilities. He agreed that the actual application of research must emanate from the centers in a regional way.
Dr. Calabresi agreed with the overall focus described by Dr. Simone but expressed concern with the statement that some of the centers are going to be more specialized in one area or another. Dr. Simone explained that the Group's position is not for more specialization, but rather to recognize the fact that some cancer centers excel in a smaller spectrum rather than the entire spectrum, and these excellences should be used to the advantage of other centers. Dr. Rimer conveyed her understanding of the foregoing discussion, namely, that the Group is recognizing that even within an area like prevention, areas of excellence need to be developed. The Working Group recognizes that that all cancer centers cannot be all things to all people and excel in all kinds of research.
Dr. Freeman agreed and asked if all centers cannot do all things, and that some centers can be given as much respect for excelling in cancer control research with modest basic research as is given to those centers doing basic research with very little cancer control research. The point was well taken. Dr. Freeman stated that he sees cancer centers that are fundamentally basic research centers, and which are doing an excellent job at basic research, and say they are reaching the community—but they probably are not to any extent. He emphasized the need for promoting this other kind of research—no matter its name. He suggested the possibility of building up basic research capabilities at the sites excelling in community outreach research so that both types of centers could be working on the problem from opposite ends of the pole and reaching toward each other.
In that regard, Mrs. Brown related that she and Dr. Goldman had convened the directors of all centers in the Washington, D.C. area to discuss the need for a cooperative cancer control initiative. The initiative would take advantage of the fact that community hospitals, which have the population base, could collaborate with research institutes, which have the specialized expertise. Mrs. Brown suggested that there is a way to apply such a strategy to the cancer centers problem and that the time has come for the Board to encourage a move in this direction. She recognized that any application of such a strategy would require tailoring it to the needs and resources of the different communities. Dr. Rimer agreed and noted that this suggestion is particularly salient in communities where there is more than one cancer center, and where the need to determine areas of specialization is important. She expressed the view that, as the Working Group is writing its report, the Board has the challenge of preparing its response to the report, deciding how to review the recommendations, and thinking about implementation. She charged Dr. Day as head of the Cancer Centers Subcommittee and Dr. Bishop with helping to guide the Board. Dr. Rimer relinquished the floor to Dr. Kalt for the introduction of Dr. Wendy Baldwin, Deputy Director for Extramural Research, NIH.
In his introduction, Dr. Kalt reminded those present that reinvention in the government started officially when Vice President Gore announced the initiative, and he noted that the announcement served as a reminder to NIH scientist administrators in the NIH extramural programs. Measures of that progress can be found by logging onto the NIH home page or the NCI home page or by using the EDISON invention reporting system. Dr. Kalt introduced Dr. Wendy Baldwin, Deputy Director for Extramural Research in the Office of the Director, NIH, and commended her for her success in moving the NIH toward the 21st century. Dr. Kalt announced that Dr. Baldwin would present an update to the Board on the continuing array of activities that have been going on in the reinvention process.
Dr. Baldwin thanked Dr. Kalt for his introduction. She welcomed the opportunity to review the extent of the changes that have taken place since the NIH started its reinvention activities in response to the National Performance Review (NPR) plan and Vice President Gore's announcement of the initiative. The statement had indicted the system, not the federal worker, and set very clear goals that provided an opportunity to make some changes in a system where the basic mission had become obscure over the years. Dr. Baldwin observed that Dr. Varmus easily identified the NIH mission as that of finding and supporting the best science. Armed with many goals and objectives, the NIH staff began the task of reinventing and making the system work for the NIH and for the scientific community. The first step was to form a cascade of committees that were charged with thinking about reinvention. She noted that one tenet of reinvention was that changes would be required in practices based on culture and tradition, but not laws or regulations. By that reasoning, it was quite likely that many of the changes the NIH would want to make would not require congressional action, although the NIH was prepared for that too.
Dr. Baldwin reported that many pilot projects are in progress. She noted that her occasional encounter with a reinvention activity that she is not familiar with means that the system is working exactly as planned. When reinvention was started, the sheer complexity of the NIH was found to be both a plus and a minus. On one hand, "a thousand flowers" had been left to bloom, possibly to the NIH's detriment. On the other hand, the fact that the NIH does have many different components and different levels means that it has not been necessary to change the whole process in one wave. This has been particularly important for extramural research, because reinvention does not mean a one-size-fits-all strategy that can be applied for extramural programming across the NIH. Because of the legitimate variation that exists across the NIH, it has been necessary to ensure flexibility to accommodate the different needs that range, for example, from those of the NCI (with its size, complexity, and longevity), to those of the National Institute of Nursing Research (NINR) (which is very new, establishing itself, and much smaller), and finally to those of the National Center for Human Genome Research (NCHGR) (which is quite different from all other institutes).
Dr. Baldwin explained that it has been necessary to make sure the extramural community can interact with the NIH as a whole, without having to relearn a different system for each Institute. As reinvention activities move into the area of electronic interfacing, this same uniformity will be essential among all government agencies. Extramural institutions have been concerned that each agency would reinvent processes in its own way. Dr. Baldwin gave assurance that several levels of interagency committees are working to ensure that this does not happen.
She reported that reinvention activities began with peer review and is now moving into grants management and will then move to all areas of extramural programming. Dr. Baldwin explained that changes to the grant application review system have led to a "streamlined" review process using triage to identify applications that reviewers believe are in the top half, which then are discussed and scored. Streamlined review is now universal throughout the Division of Research Grants (DRG); no bias was found for young investigators, women, or minorities. Dr. Baldwin stated that this process was adopted to focus discussion at review meetings on those applications which required most discussion. The process has also saved money.
Another streamlining innovation is to send applicants the original reviewers' comments rather than the synthesized summary of reviewers' comments. This innovation was well received in the scientific community and effected an enormous change in the workload for NIH staff. The final innovation in streamlined review is the direct mail-out of reviewer comments. In addition, every effort is being made to identify other stages in the review process that can be made more efficient.
One innovation currently in a pilot stage is the Just-in-Time concept, which is based on the premise that institutions should not be required to submit certain kinds of information until the information is needed. Data that are important for the award but not important for the scientific review, such as budget details, are not collected until an award is likely to be made. The NIH is now looking into the feasibility of expanding the Just-in-Time concept into the area of human subjects and animal welfare reviews. Dr. Baldwin stated that the NIH is moving carefully on this innovation.
Dr. Baldwin next described the Electronic Research Administration (ERA) initiative, which she characterized as the essence of the NIH electronic exchange function. ERA represents a commitment to improving administrative operations between the NIH and the grantee community through information technologies and reengineering of the administrative process. A key feature is to maintain the information required for various NIH processes within a client-server "common file" database. For example, a Common Application File would provide a way for the NIH and authorized awardee institutions to review and add information as required. This would eliminate the need for individuals to convert information—which now exists electronically in the institutions—into hard copy and send it to the NIH, where it is then rekeyed. The NIH would be able to provide application-specific information such as the assignment and the score to the electronic file.
Dr. Baldwin commented that feedback from institutions which receive information electronically from other sponsoring agencies indicates that 80 percent of their contacts with the agencies are eliminated if it is possible to tap into an electronic file and obtain a status report for an application. Notice of grant award as one piece of information should be available within the year through the common file.
The Grants Policy Statement, which can be accessed through the NIH Home Page, provides the most current information on deadlines, policy, and background in an organized, structured format. Dr. Baldwin noted that the NIH Home Page had been envisioned as a cornerstone for electronic communication, and it proved to be an invaluable lifeline during the government furlough and shutdown.
Dr. Baldwin emphasized that the NIH reinvention activities are an evolving operation, which will continue to rely on the valued input of all interested parties. The NIH is attempting to make information available that will help the components of NIH find useful processes and procedures to best achieve the overall mission of finding and supporting the best science. Dr. Baldwin commended the NCI's AER as an example of finding new ways to address the underlying issues that slow up the grant application process.
Dr. Day observed that confidentiality is going to become more of an issue and he asked how the NIH plans to manage it. Dr. Baldwin responded that the issue was raised when the NIH started to develop EDISON for electronic invention reporting, because the information involved required confidentiality. To that end, the NIH developed a three-level layer of security, and counted on having affordable encryption technology available when the system was ready for full-scale operation. Dr. Baldwin concluded that confidentiality is an issue that has been dealt with in other arenas of electronic commerce; the NIH has given it a high priority, and it is a manageable issue.
Dr. Goldson asked Dr. Baldwin if she thought the full implementation of electronic reporting and electronic grant submissions will affect staffing requirements negatively, in terms of full-time equivalents (FTE). Dr. Baldwin responded that efficiency would probably improve and that staffing needs on both the NIH and the Institute side would change. Whether the overall change results in fewer people needed is unclear, in part because of the level of support required to keep any kind of electronic system running.
Dr. Chan observed that the front pages of applications now contain the investigator's Social Security number. He asked whether existing policy dictates that this information must appear on the front page and how confidentiality would be maintained with outside reviewers. Dr. Baldwin responded that the NIH always makes the distinction between information that is available widely or not available, whether or not it is received and maintained electronically.
Dr. Schein asked if the NCI has any plans to transmit—by CD-ROM or some other electronic means—the voluminous materials now contained in the Board books. Dr. Kalt replied that the NCI has been piloting the electronic submission of the summary statements with several Board members and has the capability to put the whole Board book online, but there are several limiting factors. One is that different Board members have both different computer systems and different degrees of comfort with operating in an electronic environment. Another is that, for applications, specific conflicts are sorted out for each individual member. A third factor is whether members of the Board wish eventually to have hard copy of some items. Dr. Kalt stated that the NCI can eliminate paper and plans some pilot experiments in the future. Dr. Rimer confirmed that the task is confounded by the fact that Board members have different preferences in formats or vehicles for receiving information. She pointed out that Dr. Kalt and his staff in DEA have been trying to respond to everybody and tailor materials to their needs.
Dr. Baldwin predicted that a best-practices document will be available in the next 6 to 9 months with information from the Institutes that have experimented with different ways of making information available electronically, and the NCI will be able to weigh the pros and cons concerning different strategies.
Dr. Day referred to a legal suit working its way through the system having to do with manuscript review and a sequence that was used for a patent that actually appeared in a manuscript. He indicated that the suit has ramifications, particularly for progress reports, which might contain process information that would not be going to publication at that point, but might be of great commercial interest. He predicted many changes because of the nature of the information that has to be protected when electronic communication replaces paper. Dr. Day acknowledged that paper does not necessarily guarantee confidentiality, but he emphasized the need for awareness as information goes out in a system that is widely susceptible to hacking.
Dr. Baldwin agreed with Dr. Day's concern that moving the electronic side of reinvention forward must be done very carefully. Dr. Rimer offered the services of the Board in piloting reinvention activities as appropriate. Dr. Baldwin commented that the NCI already has a large investment in reinvention activities, and she expressed appreciation for the time people have spent bringing their Institutes' perspective to bear and helping to define better ways for doing business.
Dr. Correa asked how the electronic system is being developed with other entities such as the American Cancer Society (ACS) or the National Science Foundation (NSF). Dr. Baldwin explained that a Research Managers Group has been formed including herself and representatives from the NSF, the Department of Energy (DoE), DoD, and the Air Force to ensure uniformity among the agencies. A Business Practices Group is operating at a much more practical level, and Dr. Baldwin described some types of business practice agreements that are being worked out with other agencies. She explained that Web-based activities can accommodate interaction with an individual investigator and with institutions holding one or two grants, but they are inadequate for clients such as Johns Hopkins—with whom the NIH does about $300M worth of business. Therefore, a system called the EDI, the Electronic Data Interchange, is being developed, which is building a common format in the commercial sector to ensure that the NIH and these types of clients can have computer-to-computer exchange of information. Another example of interagency collaboration is software that converts a Lotus spreadsheet in the NIH format to NSF format or vice versa with the flip of a toggle switch.
Dr. Rimer thanked Dr. Baldwin for her presentation and commended her for a job well done.
Dr. Rimer reminded the Board of its request for an update on the NCI's progress in implementing the Bishop-Calabresi Report. She introduced Dr. Bishop to set the framework for Dr. Klausner's report by providing an overview of the committee's findings. Dr. Bishop observed that it has been just 1 year since this extramurally constituted Ad Hoc Working Group of the NCAB was asked to report on its evaluation of the Intramural Research Program (IRP) and make recommendations about how that program might be improved. He then reviewed the major issues that were considered and the major recommendations that ensued.
First, strategic planning was felt to be inadequate with respect to consultation, and too remote from the substance of science. The Working Group recommended: (1) more abundant use of consultation with scientists—both from within the Intramural Program and from the extramural community; (2) maintenance and improvement of liaisons with the NCAB; and (3) regular attention by the NCAB to the balance between the IRP and the Extramural Research Program (ERP). The Working Group believed that improving and reforming strategic planning at the NCI might have substantial impact on how awarded funds were used.
The second group of recommendations related to the organization of NCI. The Working Group recommended strongly that the IRP and the ERP be completely separated rather than interdigitated—as they had been traditionally—and that there be explicit leadership for the each program. The Working Group recommended that there be fewer chiefs and a simplification of the organization within the IRP—perhaps two scientific divisions. The Working Group believed there was redundancy among the laboratories and room for improvement, and that careful attention should be given to the lower level organization. Dr. Bishop stated that the Working Group suggested a specific organizational plan as an exercise to prove that such reorganization would be worthwhile and to give the leadership of the NCI some sense of what was envisioned. There were no expectations that the reorganization would take the exact form that was recommended.
The third group of recommendations related to quality assurance in the IRP. The Working Group was concerned about the history of peer review and quality evaluation within the IRP. The administration of peer review was believed to be too close to the people who were immediately directing the research, hence the recommendation that the authority and administration be vested farther up the chain of command. The record of review with regard to site visits was a source of such concern that the Working Group devised a recommendation for written reviews to dramatize the concern. Included in this recommendation was a clear statement that standards should be high. Also, the Working Group was concerned that budgets had not been subject to sufficiently rigorous review and urged that this take place. The Working Group urged that a formal appeal and unified process be implemented throughout the IRP, a means by which anyone who had not fared well would be able to make a case in rebuttal.
The fourth set of recommendations related to stewardship review and tenure policy in the IRP. Dr. Bishop stated that the Working Group perceived what it called "ethos" as one of the largest problems encountered. The committee believed that the administration of funds and even the direction of research was executed in a top-down manner, and that inadequate independence existed among many of the younger scientists and at the lower levels of advancement. The Working Group urged that this be examined carefully, and that every effort be made to change the ethos—both by example and by practice. Among the recommendations was one for rigorous and regular stewardship review that was separate from scientific review, directed at the people who were in administrative control of units and who were responsible for younger careers.
The Working Group believed that available resources were such that—properly used and with the proper ethos—the Intramural Program enjoyed an advantage in recruiting young scientists that should be developed and exploited to revive and improve the IRP. The Working Group urged that younger scientists be given authority in practice as well as nominally over their own budgets. In that regard, the Working Group suggested institution of a modest-sized competitive grants program that would allow young scientists to compete for money by way of supplementing their activities and that would allow them to do this independently.
The Working Group made specific recommendations about how the careers of women and underrepresented minorities within the IRP could be fostered. In this regard, a longstanding recommendation was revived that an ombudsperson be available to the IRP for all manner of adjudication.
Clinical research in the IRP was the focus of the fifth set of recommendations. The Working Group made specific recommendations on how to improve peer review, ranging from establishing formal protocol review and monitoring committees—along the lines mandated in the extramural community by the NCI—to urging that the clinical programs acknowledge that the peer review and promotions review recommended by the Marks-Cassell Committee were reasonable for the clinical track if properly implemented. Specific recommendations were made about how many resources might be better utilized. Dr. Bishop emphasized that clinical research in the IRP was a momentous matter. The Working Group believed that intramural clinical research represents an important scientific opportunity as well as an opportunity for the NCI to play a leadership role, and that it should receive immediate and searching attention.
Another series of recommendations related to drug development in the IRP. The Working Group decided that this program should continue, but that it needed improvement. Better peer review was recommended to evaluate suitability, quality, and redundancy of efforts. The committee further recommended that the drug development program needed to be better integrated into the larger mission of not only the NCI, but also the NIH as a whole. Dr. Bishop pointed out that other opinions have since been heard on this matter and resolution is uncertain, but he noted that the Working Group favored continuation of this effort, with the help of expert consultation.
Another series of recommendations related to the FCRDC. Dr. Bishop stated that the Working Group had difficulty understanding how the FCRDC was organized and exactly how it functioned. He noted that a series of specific recommendations were made as examples of what could be done, not necessarily as mandates. Dr. Bishop explained that the Working Group could see the prospects for improving the IRP, as well as for saving money, by rearranging the FCRDC. However, the recommendations were made with the understanding that some of them might not be feasible.
Dr. Bishop concluded his overview of the Bishop-Calabresi Report by noting that the final recommendation was that the NCAB receive a progress report a year hence, in May 1996. Dr. Rimer thanked Dr. Bishop for his excellent overview of the Working Group's findings, and she called for a report on the changes that have been implemented during the year since the evaluation was completed.
Dr. Klausner thanked Dr. Bishop and Dr. Calabresi and all others who had participated in the evaluation. He praised the quality of the review and acknowledged its value as a blueprint. In particular, Dr. Klausner stated, the success and value of the Bishop-Calabresi Report was as a model that the NCI is using to change its fundamental nature and to create, for the first time, a culture of planning. The guiding principles are to formulate questions, include participants from all constituencies in the process, and ensure that advice is integrated into planning, implementation, and decisionmaking.
Dr. Klausner referred members to the Board books for a fully detailed, point-by-point description of the many accomplishments in response to each recommendation, as well as what is yet to be accomplished. He noted that a series of charts have been included that give particular information about the restructuring and about the composition of review and advisory committees.
Strategic Planning at the NCI—In response to the critique on strategic planning, Dr. Klausner reported that the NCI has moved to change its approach according to simple principles:
planning by the NCI is to be undertaken with the larger scientific community; and critical areas in need of planning will be identified. Separate advisory committees have been established to oversee the two newly separated Intramural and Extramural Research Programs. They are the Board of Scientific Counselors (BSC) for the IRP and the Board of Scientific Advisers (BSA) for the ERP.
Dr. Klausner reported that two internal committees were created—from the staff doing the work of the Institute—in response to the critique that the NCI was not structured to seek and to heed advice about how it functioned in long- and medium-term as well as day-to-day activities. The first is the Intramural Advisory Board (IAB), chaired by Dr. Claude Klee, which includes representatives of the IRP at all levels of science and of career development. The IAB has formed a series of subcommittees to focus on the following issues: (1) core facilities and the interactions; (2) communications within the IRP; (3) the review process; (4) resource distribution; (5) recruitment; and (6) administration. The chairs and co-chairs of these subcommittees have been asked to present a brief annual report outlining accomplishments and tasks to be completed in each area. The IAB meets monthly, and new policies being considered by the NCI are presented to the IAB before they are codified, thus ensuring the input of the intramural scientists whom these policies will affect.
The second internal committee is the Extramural Advisory Board (EAB), chaired by Dr. Faye Austin, which deals with issues in the ERP. Dr. Klausner emphasized that the chairs of the IAB and EAB sit on the governing body of the Institute—the Executive Committee (EC). The EC deals with overarching issues—for example, reviewing new initiatives, setting the payline, reviewing grants, managing the AER, and developing training programs. Micromanagement is no longer a function of the EC because of authorities that have been delegated to scientists. This was done to address the recommendation by the Working Group concerning the need for change in the areas of administration and science.
Dr. Klausner reported that the NCI is creating a culture and a set of mechanisms to elicit the best advice about issues from the larger community, as well as to raise questions that would not otherwise be raised. The NCI's major response to the recommendation about strategic planning recommendations was to create a planning process that involves the wisdom of the larger community in the planning and decisionmaking of the Institute.
Organization of the Intramural Research Program (IRP)—Dr. Klausner outlined the NCI actions taken in response to the critique that the structure of the IRP was complex, redundant, and administratively burdensome. As recommended, the IRP was almost completely separated from the ERP. Three divisions were created, not two as suggested by the committee, because of the size of the program and the very different science. The divisions within the IRP are the Division of Basic Sciences (DBS), Dr. George Vande Woude, Scientific Advisor to the Director; DCS, Dr. Philip Pizzo, Acting Director; and DCEG, Dr. Joseph Fraumeni, Director. The latter division also has an extramural component because of the nature of epidemiologic research—much of which is integrated collaboratively with the extramural community. Dr. Klausner stated that the reorganization has resulted in simplification in that 8 major programs, 8 branches, and 18 sections in the IRP and the ERP have been eliminated, and all division directors now report directly to him.
Responsibility for administrative management now resides in the Office of Intramural Management (OIM) in the IRP and the Office of Extramural Management (OEM) in the ERP. Administration for the entire IRP resides in the OIM under the directorship of Ms. MaryAnn Guerra, and administrative redundancies have been reduced. The six administrative management branches of the former configuration have been consolidated into the OIM and OEM, layers of review and permission for a variety of things have been eliminated, and the services to the scientific staff are now geographically dispersed through single multifunctional service centers of expertise. Dr. Klausner noted that the evaluation of individuals is now based not on the number of people they supervise but rather on the quality of service they provide to the scientists through the Administrative Resource Centers (ARCs). Dr. Klausner emphasized that the key to ensuring that everything that is done serves the science is to delegate authorities within the streamlined administrative structure. To that end, many authorities have been delegated to the ARCs. Additional procurement and technology transfer authorities have been delegated directly to the scientific staff. To help the scientific staff, the position of Laboratory Manager was created within each laboratory, and in this new configuration, the managers responsible for the administrative functions are an integral part of the laboratory. A training program has been developed to provide training in the specific skills needed for this new career track.
Dr. Klausner next addressed the reorganization of the FCRDC, which had previously included a mixture of contract and support services for both the IRP and ERP as well as independent research—some of which had never been reviewed. In the restructuring, all intramural research has been reorganized and transferred to the appropriate intramural divisions, and all the contracts that directly support that research are now part of the reviewed budgets. Dr. Klausner noted, however, that the FCRDC presents the NCI with an extraordinary opportunity to create an intellectual and service infrastructure—for both the IRP and the nation—in developmental therapeutics, developmental diagnostics, informatics and computation, animal models, and complex genetics. He stated that the NCI is working to develop a plan to turn the FCRDC into a national resource. Using a slide, Dr. Klausner delineated the new structure of the FCRDC, which has been placed under the leadership of Dr. Alan Rabson, Deputy Director, NCI. Services located there include the production facility, fermentation facility, drug discovery core, supercomputer, and animal production facilities.
Quality Assurance—Dr. Klausner stated that quality assurance for the IRP of the NIH as a whole has been a topic which he frequently addresses, and he agreed with the assessment of the Bishop-Calabresi Report. To that end, the chartered BSC and its subcommittees have received clear guidelines regarding the nature, format, and expectations of site visits. These guidelines have been formalized in the new booklet entitled Intramural Organization and Principles (IOP). This booklet is key to quality assurance of activities in the NCI; for the first time, principles, expectations, structures, and design of processes are clearly written to be rigorous but fair. Both the reviewers and the reviewees know exactly what to expect, know what the process is, and know what to prepare. To coordinate the review process, the Office of Advisory Activities (OAA) has been established in the DEA, and it will facilitate effective implementation of all operations of the BSC and BSA, including oversight of site visits. Dr. Klausner referred Board members to the written report of the NCI's response for more explicit details about the site visit process. He emphasized that the IOP lays out specific criteria and a format for the review and each independent principal investigator presents his or her program and all resources. The report of the site visit committee is a narrative about the quality of the science in relation to available resources, containing a recommendation to the NCI for
action in regard to allocation of resources. In addition, the IOP codifies a written response
mechanism, which allows the individuals being reviewed an opportunity to defend their program and respond to the reviews.
Dr. Klausner stated that the decision was made to continue using a site review process that combines a retrospective review with current work and plans for future work. The site reviews are expected to be rigorous; the NCI is instructing the reviewers that the intramural researchers are to be held to the same rigorous criteria for valuable, creative, and innovative science as the extramural community. Dr. Klausner reiterated that the resources of each principal investigator, as well as the science, will be reviewed. In terms of resources, the NCI has established cost-management principles and zero-based budgeting. A key element is the fact that the budget and all resources are given to the principal investigators, including both those in the tenure track and the junior investigators. The budget built by each laboratory or branch chief is the sum of the budgets and resources of the principal investigators in that lab or branch, but the budgets and resources are the domain of each principal investigator. The laboratory or branch chief is the advocate of the principal investigators to the division director. The laboratory or branch budget also includes budgetary support for core facilities as well as for the general environment of the division.
Dr. Klausner reported that allocating the budgets to the principal investigators using zero-based budgeting and cost-management principles has resulted in a reduction in intramural funding without any site visit review. Thirty-one out of the 45 intramural laboratories received decreases ranging up to 33 percent in their FY 1996 budgets. Dr. Klausner affirmed that the NCI will heed the advice received during the site review process. He emphasized the importance of ensuring that the research in the intramural laboratories of the NCI is of the highest quality and that the structure reflects the support of independent scientists at all levels of their careers.
Stewardship Review and Tenure Policy in the IRP—Dr. Klausner quoted the critique from the Bishop-Calabresi Report: "The IRP environment is not conducive to encouraging young investigators by rewarding creativity and excellence. Inadequate recruiting and promotion policies further undercut the scientific talent and diversity of the staff." Dr. Klausner outlined NCI's plans for addressing the issue of developing and renewing talent. Every 4 years, division directors will undergo an independent review conducted by the BSC to evaluate the degree to which they ensure appropriate stewardship of their resources. They will also be reviewed for their ability to recruit an outstanding and culturally diverse group of scientists and for implementing programs for career development, training, and mentoring of nontenured staff.
Dr. Klausner explained that, in the quadrennial reviews by the BSC, every laboratory and branch chief will be reviewed as a scientist and principal investigator, but they will also be reviewed in terms of their encouragement and facilitation of the development of independent scientists under their supervision; those criteria are clarified in the IOP.
Dr. Klausner stated that the NCI policy is to conduct nationwide and open searches for recruitment of tenured and tenure-track scientists for all scientific positions. Dr. Klausner also reported that the NCI is in the process of creating a new career development pathway for very young scientists, called the NCI Research Scholars Program. It is modeled after a Whitehead Scholars
Program and is aimed at providing an opportunity for outstanding young investigators to launch
independent research careers at the NCI; these are not tenure-track positions.
Dr. Klausner announced that a career development office has been established under the leadership of Dr. Dinah Singer, an outstanding intramural scientist. New guidelines have been developed that codify promotion, tenure, tenure-track, and recruitment policies. The NCI has also developed an Affirmative Action Plan to increase gender and ethnic diversity at the Institute. A new recruitment program—now being developed through this office—is targeted at identifying highly qualified individuals who are culturally diverse.
Clinical Research in the IRP—Dr. Klausner stated that he agreed with the Working Group's assessment that the IRP provides the NCI investigators with an opportunity for creative and important research that is unique in this country. Because of the lack of constraints and demands that the health care system places on this Institution, intramural scientists have an extraordinary opportunity to realize the ideal clinical research environment. The leadership of the DCS will be critical to this effort, and Dr. Klausner expressed confidence that the NCI will be able to recruit an outstanding individual to that position.
In line with the recommendations of the Report, a DCS Protocol Office is being created in conjunction with the Cancer Therapy Evaluation Program (CTEP), which is in the extramural Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), to facilitate protocol development. In addition, a Protocol Review and Monitoring Committee (PRMC) was created, which has conducted a retrospective review of all of the active intramural clinical protocols. Dr. Klausner reported that the NCI had 266 open protocols at the beginning of the review, 190 of which were open for active accrual. As a result of the review, 50 of these were closed. Through the review process, the PRMC has identified an additional 55 requiring a second-level review, which is under way; 29 of the 55 have been reviewed, and 16 have been closed or recommended for closure. In addition, the PRMC has developed criteria for prospective review of new protocol concepts to ensure optimal scientific investment.
Dr. Klausner reported that the NCI also has established an Education and Mentoring Committee within the DCS. A handbook for mentoring has been developed and plans for developing a syllabus for training clinical investigators are under way. In addition, a training program in cancer genetics is being shared across all three intramural divisions.
Dr. Klausner stated that, through the site visit and review programs, the NCI will be assured that the clinical programs are as rigorously reviewed as any of the other programs. He noted that the FCRDC clinical program has been reviewed, and he would be presenting the recommendations of the review committee in the closed session.
AIDS-related Activities of the IRP—In FY 1995, the AIDS budget of the NCI was $225M. Dr. Klausner stated that Dr. Rabson has the authority and responsibility for directing and coordinating AIDS research. Dr. Rabson will deal with issues raised by the Ad Hoc Working Group, such as how the NCI determines what are AIDS monies; what the NCI spends on AIDS research; what should be spent; and how AIDS research should be coordinated among the NCI, the other Institutes, and the OAR. Dr. Klausner noted that the major thrust of the NCI activities should and does relate to AIDS malignancies. As mentioned earlier, the AIDS Malignancy Working Group, chaired by Dr. Feigal, has met and made several recommendations, one of which is to identify the Institute's AIDS
malignancy research. As a starting point, Dr. Feigal is compiling a handbook of the NCI's AIDS malignancy activities.
Dr. Klausner reported that the NCI has acted on a number of new AIDS initiatives. One important initiative began in August when a group of scientists developed scientific guidelines to define what the NCI considers to be AIDS and AIDS-related research within its various disciplines. He acknowledged the difficulty of this process, because the precise boundary of valuable scientific contributions to any area cannot be known. He cautioned against believing that advances against AIDS will be improved by the ability to define precisely where the progress will be. He noted the need, however, to be able to defend intellectually the choices made by the NCI. According to the guidelines, projects that involve working with HIV and AIDS patients were considered direct AIDS research and could be funded totally with AIDS money. Projects that were clearly applicable to AIDS research, such as research in central nervous system (CNS) lymphomas or Kaposi's sarcoma, even if they were not in the context of an individual infected with HIV, were to be examined on a case-by-case basis. These could be funded at a 30 to 70 percent level with AIDS money. A third category included projects embodying fundamental aspects of AIDS research related to virology and immunology. For this categorization, the committee found the Levine Report helpful for its recommendations about increased investment in human immunology and opportunistic infections, including infectious agents that may be involved in malignancy or malignant progression. Dr. Klausner stated that the NCI has used these criteria to adjust its coding and also to address the imbalance in the distribution of the AIDS monies between the IRP and the ERP. As a result of this review and recodification and in response to the Report of the NIH AIDS Research Program Evaluation Working Group, the decision was made to shift more of the NCI's AIDS funding into extramural investigator-initiated research projects.
Dr. Klausner reviewed the significant changes in the NCI's AIDS budget estimates for FY 1996. He highlighted the following in the ERP funding estimates: (1) $7M was moved immediately from the IRP into Research Project Grants; (2) using the process for coding the NCI projects as AIDS, AIDS-related, or fundamental to an understanding of AIDS, the NCI has arrived at the current estimate of $96M, down from $102M; (3) the Centers total includes a new program in AIDS malignancies; (4) funding to the cooperative groups has been increased in response to the recommendations from the AIDS Malignancy Working Group; (5) funding to the AIDS Malignancy Consortium and AIDS malignancy bank has been increased; and (6) funding has been included for the DCEG initiative to develop databases on AIDS epidemiology by linking AIDS and cancer registries in several areas of the United States. With these changes, NCI funding for the ERP has increased substantially.
Dr. Klausner pointed out changes in other lines of the NCI AIDS budget for FY 1996. The number of R&D contracts was reduced. AIDS funding in intramural research has decreased to $44M. This constitutes a 44 percent decrease in 9 months in the amount of AIDS money in the IRP.
Dr. Klausner reported on another NCI AIDS initiative. To reduce redundancy found during a review of AIDS and AIDS-related projects, as well as to promote communication among scientists, the NCI is creating a consolidated AIDS program within the DBS, to be housed in a new research building in the FCRDC. Components of the new program are the basic research program at Advance BioScience Laboratories, Inc. (ABL), the Biomedical Supercomputing Center and AIDS Vaccine Development Program at Science Applications International Corporation (SAIC), the Laboratory of Leukocyte Biology (LLB), the Laboratory of Viral Carcinogenesis (LVC), the Laboratory of Molecular Oncology (LMO), and the Laboratory of Tumor Cell Biology (LTCB). A national search is under way for an outstanding scientist to lead this program; the search committee is chaired by Dr. John Coffin.
Dr. Klausner reported that a new laboratory has been created to integrate the AIDS malignancy and AIDS research efforts at the Clinical Center. This new laboratory, with Dr. Robert Yarchoan as Acting Director, unifies adult and pediatric approaches to AIDS research previously located in the Medicine and Pediatric Branches of the DCS.
Dr. Klausner announced that the DCEG has recruited an epidemiologist with 10 years of experience with the SEER Program, who is particularly interested in AIDS malignancy and AIDS epidemiology. This individual will work in DCEG to help coordinate the informatics and database efforts related to epidemiologic and multidisciplinary studies of AIDS-related malignancies.
NCI at the Frederick Cancer Research and Development Center (FCRDC)—Dr. Klausner referred to a diagram showing the new configuration of FCRDC and pointed out that the NCI responded to much of what was recommended in the Bishop-Calabresi Report. The entire program was disaggregated and all basic research programs have been relocated to appropriate divisions. Principal investigators who were on contract have been identified, and investigators with independent resources who have never gone through the recruitment process will be reviewed over the next year. The entire program at FCRDC will be reviewed this summer. The Biological Response Modifiers Program (BRMP) was discontinued as a separate program, but individual branches and laboratories have been relocated. The Clinical Research Branch is now part of the DCS, and all of the laboratories conducting basic research in immunology are under the DBS.
Drug Development in the IRP—Dr. Klausner stated that the drug development program is being studied by the Institute. NCI has a critical role to play in the discovery and development of new therapeutics. Because of the importance of that area and the complexity of the relationship among government, industry, and academia, the NCI has asked for a review to guide the Institute in determining future directions for its drug discovery and development efforts. The NCI will postpone making any decisions about developmental therapeutics until it is able to take a much broader and more detailed look at the program. Dr. Klausner reported that, in the meantime, the Developmental Therapeutics Program (DTP) has been disaggregated. The laboratories identified as clearly conducting intramural research are now part of the IRP in the DBS, but the DTP, with Dr. Edward Sausville as Associate Director, is part of the ERP in the DCTDC.
Dr. Klausner referred Board members to his written report for a more complete and detailed account of the NCI's response to the Bishop-Calabresi Report. He observed that the changes in the NCI have been substantial, significant, and real. He acknowledged that changes of this magnitude raise great anxiety and uncertainty and noted that the NCI staff has dealt with those issues appropriately. He commented that everyone in the NCI community has worked with this program and all—not only staff members who helped formulate and implement it—are to be congratulated on their ability to deal with the enormous challenges.
In conclusion, Dr. Klausner thanked Dr. Bishop, Dr. Calabresi, and all members of the Ad Hoc Working Group for their help. He pledged the Institute's continued responsiveness to the recommendations of the NCAB and of the advisory groups that will help recreate an Institution that will be successful in fulfilling its mission.
Dr. Rimer thanked Dr. Klausner and commended the comprehensiveness of his report. Because she believed the Board could not adequately address all that had been reported in the limited time left in the meeting, she asked Dr. Bishop and Dr. Calabresi to review the written report over the summer, along with any updates received from the NCI, and lead a discussion at a future meeting after all members have had an opportunity to read and consider Dr. Klausner's full report. Dr. Calabresi agreed to the request. He commended Dr. Klausner and the NCI staff for the amount of work they had done in so short a time while implementing the recommendations in the Bishop-Calabresi Report, and thanked Dr. Klausner and everyone for their efforts.
Dr. Rimer opened the floor for a brief discussion in the time remaining before the executive session.
Dr. Chan asked about the optimal distribution of intramural versus extramural funds. Dr. Klausner pointed out that intramural funds over 1 year have decreased from about 18.8 percent of the NCI budget to 18 percent and are estimated to decrease to 17.5 percent of the total in FY 1997. He stated that further changes cannot and should not be made precipitously. He asked that the IRP be viewed for its outstanding accomplishments, ability to function well, efficient and effective use of funds, and support of extramural research rather than as a competitor with extramural activities. Dr. Day pointed out that the Working Group explicitly avoided specifying a number for funding and made the additional point that the number could be computed differently by including contract support; he noted that a major transfer of funds had occurred there. Dr. Klausner observed that calculating intramural funding proved to be difficult, and that the decrease was probably larger than described because of changes made in NCI contracts.
Dr. Day commented that he and a number of people have been concerned about the comparability between reviews of the IRP and the kind of review that a R01 or a P01 undergoes in intramural reviews. Dr. Klausner clarified that the NCI intramural reviews would be a mix of past and present accomplishments and plans for the future, as requested by the BSC. Dr. Day asked how the extensiveness and rigor of that review will compare with reviews conducted through the DRG mechanism. Dr. Klausner agreed that the two processes differ. Intramural laboratories will be reviewed during a site visit by expert and experienced extramural scientists who will be evaluating on the basis of one straightforward goal, namely, that the IRP be regarded as one of the great centers of science. Dr. Klausner emphasized that the site-visit process will be monitored and will change over time as needed to ensure that it works well. He pointed out that extramural investigators may have multiple sources of funding other than a particular R01, whereas, an investigator in the IRP has only the one source of funding. Thus, the intramural review process must be tailored to the nature of what is being reviewed—that is, the totality of a person's scientific career at a given moment as opposed to funding or partial funding for one of his or her projects.
Dr. Calabresi agreed that the NCI should follow the advice of the BSC and base reviews on past performance and future direction, but he urged that the NCI not duplicate internally what is being done externally. Dr. Klausner agreed and noted that a significant aspect of the intramural review will be retrospective, which is different than what has been done with an R01. He pointed out, however, that scientists prefer to focus on what they are doing now and where the research is going. If their projects are going to be risky, creative, and exciting, these intramural scientists will fare very well in these reviews. The NCI will attempt to strike a balance concerning past performance and future direction. Dr. Bishop expressed the view that the Working Group would not object to the change, because of the difficulty experienced in reaching the original consensus on the recommendation that intramural review should be retrospective.
On behalf of the Board, Dr. Rimer commended Dr. Klausner and all other NCI staff for their accomplishments over the past year. She announced that the Board would move immediately into the closed session with Dr. Klausner, and she adjourned the open session of day one at 12:30 p.m.
Dr. Rimer convened the second day of the 98th meeting of the NCAB with the reminder that persons wishing to comment on any item of business could do so by writing to Dr. Kalt within 10 days after the meeting. She gave a brief overview of the day's business (announcement of the U.S. Postal Service-NCI breast cancer initiatives, reports from the subcommittees, forum on issues related to genetic susceptibility testing) and asked for comments from Dr. Klausner on his meeting at the White House the previous afternoon.
Dr. Klausner reported that First Lady Hillary Rodham Clinton chaired a session at the White House on breast cancer awareness, which featured testimony from survivors, activists, and representatives of the Administration. Mrs. Clinton used the opportunity to comment on the NCI's announcement the day before of new data demonstrating a further reduction in mortality from breast cancer, which expanded and extended a continuing trend to more segments of the U.S. population. She also communicated the Administration's commitment to research in breast cancer and to actions that ensure access by all to screening and treatment.
In her remarks introducing the first presentation, Dr. Rimer briefly reviewed Mr. Marvin Runyon's professional career before becoming Chief Executive Officer (CEO) and Postmaster General of the United States Postal Service (USPS) in 1992. She remarked that he now leads an organization with 750,000 employees that reaches every American, making the collaboration between the USPS and the NCI to promote awareness of breast cancer and breast cancer screening one of the largest outreach efforts ever launched. The initiatives to be undertaken include printing and disseminating 100 million breast cancer awareness stamps, publicizing the 800 number of the Cancer Information Service (CIS) (1-800-4-CANCER), making materials about breast cancer available at all local post offices, and sponsoring collaborations between local postal services and CIS outreach workers. Dr.
Rimer showed a video based on a talk given by a postal worker, Ms. Diane
Dr. J. Michael Bishop
Dr. Richard J. Boxer (absent)
Mrs. Zora K. Brown
Dr. Kenneth K. Chan
Dr. Pelayo Correa
Dr. Robert W. Day
Dr. Kay Dickersin (absent)
Mrs. Barbara P. Gimbel
Dr. Alfred L. Goldson
Mrs. Marlene A. Malek
Dr. Philip S. Schein
Dr. Ellen V. Sigal
Dr. Vainutis K. Vaitkevicius (absent)
Dr. Charles B. Wilson
Dr. Paul Calabresi
Ms. Frances M. Visco
Ms. Lynn Jenkins, NIOSH
Dr. Marilyn A. Fingerhut, NIOSH (absent)
Capt. Bimal C. Ghosh, DoD
Dr. Hugh McKinnon, EPA
Ms. Rachel Levinson, OSTP
Dr. Lakisma C. Mishra, CPSC (absent)
Dr. Kenneth Olden, NIEHS
Dr. Paul Hoffman, DVA (absent)
Dr. P.C. Srivastava, DOE
Dr. Ralph E. Yodaiken, DOL
Dr. Alan Rabson, Deputy Director, National Cancer Institute
Dr. Edward Sondik, Associate Director, Strategic Planning
Mr. Philip D. Amoruso, Associate Director for Extramural Administrative Management
Ms. MaryAnn Guerra, Associate Director for Intramural Administrative Management
Dr. Faye Austin, Director, Division of Cancer Biology; Chairman, Extramural Advisory Board
Dr. Joseph Fraumeni, Director, Division of Cancer Epidemiology and Genetics
Dr. Peter Greenwald, Director, Division of Cancer Prevention and Control
Dr. Marvin Kalt, Director, Division of Extramural Activities
Dr. Philip Pizzo, Acting Director, Division of Clinical Sciences
Dr. Robert Wittes, Director, Division of Cancer Treatment, Diagnosis, and Centers
Dr. George Vande Woude, Scientific Advisor to the Director for Basic Sciences; Director, Advanced BioScience Laboratories, Inc., NCI-Frederick Cancer Research and Development Center
Dr. Claude Klee, Chairman, Intramural Advisory Board, Board of Scientific Counselors
Dr. David Livingston, External Advisor, Chairman of the NCI Extramural Board of Scientific Advisors; Professor of Medicine, Dana-Farber Cancer Institute
Dr. Martin Abeloff, External Advisor and Co-Chairman, Clinical Sciences Subcommittee A of the NCI Intramural Board of Scientific Counselors; Professor and Director, Johns Hopkins Oncology Center
Dr. Edward Harlow, External Advisor and Co-Chairman, Basic Sciences Subcommittee B of the NCI Intramural Board of Scientific Counselors; Member, Massachusetts General Hospital
Dr. Alfred Knudson, External Advisor, Special Advisor to the NCI Division of Cancer Epidemiology and Genetics, Acting Director Intramural Genetics Program; Senior Member, The Institute for Cancer Research, Fox Chase Cancer Center
Mrs. Iris Schneider, Executive Secretary, Assistant Director for Program Operations and Planning
Dr. Maureen O. Wilson, Executive Secretary of the President's Cancer Panel
Dr. Marc E. Lippmann, American Association for Cancer Research (absent)
Dr. Robert Martuza, American Association of Neurological Surgeons (absent)
Dr. John Laszlo, American Cancer Society (absent)
Ms. Kerrie B. Wilson, American Cancer Society
Ms. Elaine Locke, American College of Obstetricians and Gynecologists
Dr. Stanley Zinberg, American College of Obstetricians and Gynecologists (absent)
Dr. Bernard Levin, American Gastroenterological Association (absent)
Dr. Edward P. Gelmann, American Society of Clinical Oncology
Dr. John Glick, American Society of Clinical Oncology (absent)
Ms. Julie Taylor, American Society of Clinical Oncology
Dr. Stanley Order, American Society of Therapeutic Radiologists (absent)
Dr. Edwin A. Mirand, Association of American Cancer Institutes
Dr. Robert W. Frelick, Association of Community Cancer Centers
Mr. James Kitterman, Candlelighters Childhood Cancer Foundation (absent)
Mr. Thomas Brandt, Intercultural Cancer Council
Dr. Ronald Jones, Intercultural Cancer Council
Ms. Jean Whalen, Leukemia Society of America, Inc.
Ms. Dorothy J. Lamont, National Cancer Institute of Canada (absent)
Dr. J. David Beatty, National Cancer Institute of Canada (absent)
Dr. Margaret Foti, National Coalition for Cancer Research
Dr. Tracy Walton, National Medical Association
Dr. Eve I. Barak, National Science Foundation
Dr. James Brown, National Science Foundation (absent)
Ms. Kathi Mooney, Oncology Nursing Society (absent)
Ms. Roberta Strohl, Oncology Nursing Society
Dr. Jeffrey Norton, Society of Surgical Oncology, Inc. (absent)
Dr. Marston W. Linehan, Society of Urologic Oncology (absent)
Report of the President's Cancer Panel
Legislative Update
Progress Report on the Cancer Centers Working Group
Update on NIH Extramural Reinvention Activities
Progress in Implementation of the Bishop-Calabresi Report
Restructuring and Refocusing the Intramural Program