National Cancer Institute Reorganizing Under Cloud Of Controversy, Uncertainty

Sidebar:NCI Divisional Structure Amid a swirl of controversy over leadership, budget priorities, and stifling bureaucracy, the new organizational structure of the National Cancer Institute (NCI) went into effect October 1. The reorganization was prompted by internal, agency, and congressional studies. Under the restructuring, many programs, laboratories, and branches fall under new or redesigned divisions, with an eye toward streamlining the agency, revamping its intramural program, and opening lines of communication. FOCUS ON ATTENTION: The performance of the new NCI director Richard D. Kalusner is seen as the key to a successful institute reorganization. The latest changes in NCI's structure are being put into effect by the institute's new director, Richard Klausner, whose performance is considered by many as the key to the effort. Klausner assumed the NCI directorship August 1. Formerly the director of the Cell Biology and Metabolism Branch of the National Institute of Child Health and Human Development (NICHD), he headed a committee studying intramural research at the National Institutes of Health during Bernadine Healy's tenure as NIH director. COMMON SENSE: Vincent De Vita says NCI personnel have felt a leadership void. "There was a problem at the NCI that I think we all felt," states former NCI director Vincent De Vita, now director of the Yale Cancer Center at the Yale University School of Medicine. "People need to know that there's some leader there [who] can respond. There was a sense in the organization that this was not there [in the recent past]." De Vita, head of NCI from 1980 to 1988, is a staunch Klausner supporter. Although the basics of the agency's reconfiguration have been known since August (E. Marshall, Science, 269:912-3, 1995; S. Stockwell, Oncology Times, 17(10):1, 1995), the laboratory and branch placement are so new that, at press time, some personnel within NCI were still unaware of where their sections fit within the structure. NCI officials were unwilling or unable to give The Scientist all but the barest details. And many who work closely with the institute refused to comment before the November 27-29 meeting of the National Cancer Advisory Board (NCAB), at which the new structure officially will be announced. Nevertheless, the new departmental structure was published in the Cancer Letter (21[39]:3-4, Oct. 13, 1995; see accompanying table). As part of a review of the overall intramural research program (IRP) of NIH, Congress mandated in fiscal year 1994 that NIH review each of the institute's IRPs and their relationship to the extramural research program (ERP). The External Advisory Committee (EAC) of the Advisory Committee to the Director of NIH reviewed NCI's IRP and presented its report, which clearly identified several areas of concern in spring 1994. The latest report, a continuation of the process, was presented in June by the Ad Hoc Working Group of the NCAB on the Intramural Research Program (called the Bishop-Calabresi Report after its two cochairmen, J. Michael Bishop of University of California, San Francisco, and Paul Calabresi of Brown University) and cited many of NCI's previously identified problems. According to the Cancer Letter, under the reorganization there is a clearer distinction between the intramural and extramural programs. Two of NCI's seven divisions are now intramural: the divisions of Basic Sciences, Clinical Sciences, and Cancer Epidemiology and Genetics. The Division of Cancer Epidemiology and Genetics has both intramural and extramural functions. The remaining four divisions (Cancer Prevention and Control; Cancer Treatment, Diagnosis, and Centers; Cancer Biology; and Extramural Affairs) are almost entirely extramural, and any intramural laboratories they had under the old organization have been moved to the intramural divisions. The programs now report to separate offices within the office of the director: the Office of Intramural Management and the Office of Extramural Management. NCI officials and others expect the reorganization to improve communications at NCI, because, previously, hierarchy was unclear within the institute. They caution, however, that the restructuring is a work in progress. Much of the responsibility for the reorganization is under the aegis of NCI's associate director for strategic planning, Edward Sondik. Although the Bishop-Calabresi report recommended increased commitment to the intramural clinical program, NCI spokesman Frank Mahaney says that the reorganized IRP will stress bench science in genetics, viruses, and immunobiology and will get farther away from basic clinical research. ADVOCATE: Barbara Balaban worries about cuts in clinical breast cancer research. Some of NCI's constituency question this, and others are gladdened. For example, patient advocate Barbara Balaban of the New York Statewide Breast Cancer Hotline in Garden City is concerned that NCI's intramural clinical protocols will continue to be cut back. "The clinical stuff that they've done is ground-breaking," she says. "It has been of tremendous help." But, she adds, "They've been cutting back for the last three years. Now there are fewer protocols . . . [and] that's very troublesome." She comments, "NCI has placed themselves on the leading edge [of clinical research]. Private money is going to fund this stuff? Come on!" PRUNED: Douglas Daly's natural-products collection program constract may be significantly cut. Systematic botanist Douglas Daly of the New York Botanical Garden fears that his research program-a contract to collect natural materials for screening by NCI's Natural Products Branch -probably will be considered part of the intramural budget, and may well disappear under the new regime. Daly points out that the branch "already received at least their share of cuts over the last year, which they've had to pass on to their contractors, including us." The Natural Products Branch is now listed under the Division of Cancer Treatment, Diagnosis and Centers. The Bishop-Calabresi report makes it clear that NCI's organizational problems "limit the effectiveness of the intramural research program." Although the ERP was beyond the purview of the Bishop-Calabresi committee, it recommended the program be fully separated from the IRP. The Scientist's conversations with researchers reveal that there also are problems with the ERP that need to be addressed, perhaps through this reorganization. The restructuring comes on the heels of last April's sudden departure of Samuel Broder as head of NCI. Broder resigned amid questions about his management and handling of several difficult situations, including the investigation of HIV researcher Robert Gallo, former director of the Laboratory of Tumor Cell Biology, for alleged misconduct. Gallo was accused of mishandling HIV samples that originated from France's Institut Pasteur. NIH investigations of the alleged incident were discontinued, but the political furor was perceived as hastening Broder's departure. Broder has refused to comment on the incident. Another controversy involved the falsification of breast cancer surgery data in a study conducted by Bernard Fisher of the University of Pittsburgh medical school (F. Hoke, The Scientist, Feb. 20, 1995, page 1). Although reevaluation of the data did not change the results of the study, Broder was criticized for not acting on the situation until pressured by media attention and Congress to do so. Ironically, when he removed Fisher from the study, his actions were again criticized as too harsh, separating the researcher from his lifelong work. Gallo has since joined the exodus of several senior scientists from NCI, leaving to establish the Institute of Human Virology at the University of Maryland, Baltimore (F. Hoke, The Scientist, July 24, 1995, page 3). Broder did not respond to repeated attempts by The Scientist to contact him. Former NCI director De Vita maintains that many of the institute's problems can be corrected by changing "some of the old lines of communication . . . streamlining it," and having the presence of a "leader," whom he believes to be Klausner. "Being a leader is a very difficult thing to describe. You know it when you see it. I sense in Dr. Klausner a strong capacity for leadership," De Vita declares. A FAN: John Glick believes new director Richard Klausner "clearly has a proactive vision for NCI". John H. Glick, director of the University of Pennsylvania Cancer Center and president of the American Society of Clinical Oncology (ASCO), agrees. He calls Klausner "a thinker and a doer. He clearly has a proactive vision for the NCI." Glick elaborates: "I'm very impressed by Rick Klausner's openness and willingness to have a dialogue, and to communicate. I really believe that he believes in a partnership in his new vision for the NCI." Attempts to reach Klausner were unsuccessful, and he did not respond to questions submitted by The Scientist. According to NCI communications officials, he is deferring questions until after the NCAB meeting. Observers maintain that Klausner will have his work cut out for him, and much of it will revolve around the intramural program. Not the least of these problems is that NCI allocates 25 percent of its funds (18 percent in-house and 7 percent for contracts supporting research) to the IRP. The entire NIH, including NCI, allocates only 11.3 percent of the funding to its IRP. The large discrepancy has left the perception in some quarters that NCI-supported extramural research is being short-changed, especially in a time of tight federal research funding. The Bishop-Calabresi report suggested that NCI's IRP budget be brought more into line with the rest of NIH. Areas of weakness cited by the Bishop-Calabresi report-and originally mentioned in an earlier internal NCI report, "The NCI in Hard Times," presented in January 1994-include redundancy in programs, ineffective use of staff, lack of vision and planning, and managerial problems. The Bishop-Calabresi committee was charged with considering problems of low staff morale, appropriateness of programs and facilities, and "the challenge of increasingly limited resources." SKEPTIC: Hildegard M. Schuller has "a gut feeling" NCI will not change. Even with its new leadership, some are skeptical that a structural reorganization can possibly address all of the institute's difficulties, and suggest this is just replacing the old bureaucracy with a new one. "I have a gut feeling that they will not change very much," asserts pathologist Hildegard M. Schuller, Distinguished Professor of Comparative Pathology at the University of Tennessee College of Veterinary Medicine. Schuller was employed in NCI's Division of Cancer Treatment for two years in the mid-1980s. "They will certainly pick the least-painful approach for the changes." However, some of the troubles that beset NCI, according to researchers and NCI administrators, are problems in perception. One overwhelming complaint is that, with all the money the government has expended since President Richard Nixon's War on Cancer in the early 1970s, little has been accomplished in the way of cures. "There's no return on that investment. There are no real big breakthroughs," asserts Philadelphia consultant Loren Buhle, creator of OncoLink, an online cancer-information source (F. Hoke, The Scientist, April 3, 1995, page 1). "Forty-two thousand women die of breast cancer annually. We're not doing any better there" than 20 years ago, he explains. Although cures have been found for some childhood cancers, notes pediatric hematologist/oncologist Gail Megason of the University of Mississippi Medical Center in Jackson, "for a lot of diseases, we haven't made much progress." She credits NCI-funded extramural clinical research through the Pediatric Oncology Group and the Children's Cancer Study Group with finding cures for childhood acute lymphocytic leukemia, Wilms' tumor (in collaboration with the National Wilms' Tumor Study Group), Hodgkin's disease, and lymphomas secondary to Hodgkin's disease. The drugs, however, were developed intramurally at NCI. A major challenge for NCI is that the institute must address itself to myriad disparate constituencies, including researchers, clinicians, cancer center administrators, pharmaceutical companies, patient advocates, patients, and Congress, many of whose needs or perceived needs are polar opposites. For example, researchers, activists, and clinicians are hoping the NCI reorganization will allow the institute to take a fresh look at some shortcomings in the clinical research protocols used. LEFT OUT: Lovell A. Jones claims NCI has ignored minorities in studies. Past lack of inclusion of minorities in research protocols and insensitivity to minority health issues are other shortcomings that could be remedied by the NCI restructuring, according to endocrinologist Lovell A. Jones of the University of Texas M.D. Anderson Cancer Center in Houston. Jones is cofounder of the Intercultural Cancer Council (ICC), an umbrella organization that includes representatives from numerous major cancer policy groups, cancer centers, and minority cancer-health organizations. ICC contends that the institute must consider minority issues-instructions that don't apply to minorities, a lack of involvement with minority cancer-risk populations, as well as a lack of understanding of how to reach these populations-as strongly as other major research issues. At the same time, Jones and colleagues are also concerned that NCI and NIH will consider the health of minorities as an affirmative-action issue, which they maintain it is not. The inclusion of underrepresented minorities in cancer and all medical research, says Jones, "is neither a white issue; this is neither a black issue, or a brown issue. It is an American issue." "One of the main problems with the reorganization," Jones says, "is it still doesn't address the issue with regard to a coordinated effort within the NCI dealing with minority research issues." He explains that minority issues are traditionally addressed by the Office of Special Populations. He points out that so far as he is aware, there is no special populations branch in the reorganized NCI. Moreover, he asserts, the Special Populations office has not had professional scientific leadership, having been run by individuals with bachelor's degrees and not by scientists. "You look at their special populations branch [and] it tells you where they really stand on this issue, and that's nowhere," Jones says. But Jones sees the new NCI leadership and reorganization as "a real, unique opportunity for the new director to take an assessment of where NCI has been on this issue, use that as a baseline, and begin to move forward to make strategic plans to really address the issue." The ICC is meeting with Klausner and Varmus to request a role in the continuing NCI reorganization efforts. BAD BEHAVIOR: Elmer E. Huerta hopes the institute will pay more attention to behavior-based risk factors. Preventive oncologist Elmer E. Huerta, director of the Cancer Risk Assessment and Screening Center in the Cancer Institute at Washington Hospital Center in Washington, D.C., like Jones, hopes the reorganized NCI will look at cancer in a different light. Huerta, a member of ICC, advocates not only that research "include the different racial and ethnic groups," but also that NCI understand "that 38 percent of deaths in the U.S. in 1990 were caused by factors that were directly linked to people's behavior: tobacco, diet, and alcohol." This, Huerta explains, indicates that there are "two approaches to really deal with this problem of cancer: One is the bench, laboratory work-identifying the genetics of cancer, identifying the molecules, identifying the personal risks of people. I am very much in favor of this research. But, the other approach is to deal with people's behavior because there are a lot of cancers that are related to behavior." Huerta is disappointed "that in all the news articles I have read, I have not seen any single line in the future plans of NCI talking about behavioral research." Sidebar:NCI Divisional Structure Myrna E. Watanabe is a science writer based in Yonkers, N.Y.

National Cancer Institute Reorganizing Under Cloud Of Controversy, Uncertainty

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