NCI's Reorganization, Director Scrutinized By Cancer Board

if (n == null) The Scientist 10[1]:, Jan. 08, 1996 News NCI's Reorganization, Director Scrutinized By Cancer Board By Myrna E. Watanabe Little official business was concluded at a two-day meeting of the National Cancer Advisory Board (NCAB) November 28-29. Rather, the proceedings were dominated by a lavish presentation of the wide-ranging reorganization of the National Cancer Institute (NCI) and its mercurial director, Richard D. Klausner, who orchestrated the restructuring. Klausner announced, for the first time, the "profound administrative changes" that he began to implement at NCI after he took over this position in August. He proclaimed that as of October 1, the reorganization of NCI was completed. CHANGES AFOOT: Director Richard Klausner presented NCI's "profound restructuring" to the advisory board. "Completed" may be something of an overstatement, however. As a fax from Klausner's office to The Scientist outlining the NCI organization clearly indicates-with its crossing out of branches and penciling in of names and phone numbers-the process is ongoing. "I think these administrative changes are important," Klausner told the board. "They're essential, and I think they actually represent the manifestation of the goal that we have at the institute, and that is for the institute to function internally and externally in a way that serves the science." NCAB is one of NCI's external advisory bodies, and it has the broadest charge, according to an NCAB report: "The NCAB oversees the review of grant applications and provides advice on all aspects of program and planning for cancer research." By statute, the board must approve all NCI grants over $50,000, after the proposals have been peer-reviewed and recommended by the study sections. The board includes leaders in cancer research and treatment and from the cancer advocacy community, as well as corporate leaders. Its membership is appointed by the president. Although its role is primarily advisory, its evaluations and recommendations often are strongly felt within NCI. CULTURAL PROBLEM: NCAB member Zora Brown says that "NCI can do more to accrue and retain minority scientists." "My impression is that he [Klausner] is taking many of our [the NCAB's] concerns under advisement," states NCAB member Zora Kramer Brown, president of Washington, D.C.-based Cancer Awareness Program Services, a breast cancer advocacy group working especially with the minority community. Is Klausner responsive to the board? "Oh, yes," Brown affirms. One point brought out clearly during the NCAB meeting was that the reorganization was essential, because NCI was suffering from a cancer of its own. Administrative changes in the existing bureaucracy were necessary just to run the organization. The deficiencies outlined ranged from basic technical matters to institute-wide structural and management problems. For example, the institute did not have a complete list of intramural principal investigators (PIs)-independent investigators who run research projects at the institute-nor was there any clear statement of a PI's functions and responsibilities. Budget lines were confusing: extramural grant administrators' salaries, for example, were paid out of intramural funds. But-perhaps the most glaring problem of all-there was little communication among the top, the middle, and the bottom of the organization, a situation that had been outlined in reports and was supported by statements of NCAB meeting participants. This is changing, according to Klausner and other top NCI officials, and these structural changes are expected to alleviate the bureaucratic stultification reported in June by the Ad Hoc Working Group of the NCAB. The critical evaluation is referred to as the Bishop-Calabresi report for its cochairmen, J. Michael Bishop, director of the George Williams Hooper Research Foundation at the University of California, San Francisco, and Paul Calabresi, professor and chairman, emeritus, of the department of medicine at Brown University. Both men are NCAB members (M.E. Watanabe, The Scientist, Nov. 13, 1995, page 1). Klausner announced that NCI is working on a document to define the PI's role. Cost-management principles are being initiated, and each PI will be given a "zero-based budget"-independent resources that will be negotiated annually with the laboratory and branch chiefs, who both will be advocates for the PI at the director's level. And communication is improving, institute officials insist. Claude Klee, chief of the laboratory of biochemistry in the division of basic sciences and chairwoman of NCI's Intramural Advisory Council, stated to the board that this was the "first time in my 20 years at the institute we have direct access to the director." CLEAR CHANNEL: NCI associate director Ed Sondik reports communications channels are "very open." More specifically, the intramural and extramural programs have now been separated, and a clear chain of command has been established from the researchers at the lowest rung to the PIs, laboratory chiefs, branch chiefs, division chiefs, and the director's office. Most important, according to Ed Sondik, NCI's associate director for strategic planning and deputy director for the Division of Cancer Prevention and Control, "I think there's a clear communications channel which is very open and it doesn't really have to follow that [chain-of-command] path." Now all laboratory chiefs will be required to be PIs, and each PI will be responsible for his or her own budget. This is a major change, according to one National Institutes of Health researcher who asks not to be named. This researcher explains that traditionally at NIH, "the lab chiefs sort of have an iron-fisted control of the budget. In many cases, tenured people don't have input into preparing their own budgets. Their budget is prepared for them by their lab chief." (Although most laboratories will also have from a few to many PIs working on projects within the laboratory, NIH director Harold Varmus maintains an exceptional laboratory at NCI in which he is the sole PI.) While PIs will be running laboratories, Klausner relates to The Scientist, "they're not supposed to be doing administration." They will, instead, have laboratory managers, a new job classification at NCI, who will attend to administrative functions. Shared administrative teams will work with the laboratories and assist with budgets, personnel, contracts, and other administrative responsibilities. Further administrative changes include removal of money from the intramural program into the extramural program, for example, by decreasing the number of contracts let through RFAs (Requests for Application, part of the intramural program) from $40 million to $50 million annually to $11 million to $15 million. Klausner expects this to leave more funds for individual-investigator (R01) grants. There will also be significant changes in NCI's clinical center, such as standardization and review of clinical protocols; centralization of clinical care and support, rather than having clinical care separated by department; opening of the clinical center to the extramural community; and revising the clinical training program, perhaps affecting the number and experience levels of trainees accepted to the program. Other major modifications announced include the proposed formation of two advisory boards composed of individuals from the extramural community: the Intramural Board of Scientific Counselors, which now has two subcommittees, A and B, and the Extramural Board of Scientific Advisers. Previously, each division had its own Board of Scientific Counselors. Subcommittee A, to be chaired by Martin D. Abeloff, director of the Johns Hopkins University Oncology Center, will focus on evaluation and planning in the Division of Clinical Sciences. This board will aid in the search for a permanent director of the division and will look at the intramural clinical protocols at NCI with an eye toward decreasing their number. RESPONSIBILITY: Edward Harlow chairs a subcommittee charged with revamping NCI's internal lab-review procedure. Subcommittee B is to be chaired by Edward E. Harlow of the Massachusetts General Hospital Center in Charlestown. Its responsibility includes revamping the internal laboratory review procedure. This subcommittee also has ad hoc working groups reviewing preclinical models of cancer and developmental diagnostics. The Extramural Board of Scientific Advisers, chaired by David M. Livingston of Harvard Medical School and former physician-in-chief and institute director of the Dana-Farber Cancer Institute in Boston, will maintain oversight of extramural activities. Livingston resigned last May as chief physician at Dana-Farber, along with other top leaders, after two chemotherapy overdoses at the institute, in which one patient died and another was severely injured. In a statement released by Dana-Farber, he said he stepped down because of "his strong conviction that a change in leadership was required to assure the public that a 'new eye' is examining every aspect of our patient care." His resignation came two weeks after being elected to the National Academy of Sciences (K.Y. Kreeger, The Scientist, May 29, 1995, page 3). Harlow points out that these committees now have duties they did not have under the old system of individual boards for each division. "They're always involved in scientific review," Harlow says, "but they did not have responsibilities for planning, and now they do." Harlow appreciates having "the ability to participate at the highest level, which has not been available in the past." Sondik reports that now there are also two new internal boards, consisting of intramural staff. They are the Intramural Advisory Council, chaired by Klee, and the Extramural Advisory Council, chaired by Faye Austin, acting director of the Division of Cancer Biology. These boards, Sondik says, were created by Klausner in response to a problem identified in the Bishop-Calabresi report. "The staff felt that they were removed from the institute's highest level decision-making," says Sondik. The chairs of these two staff boards sit on NCI's Executive Committee. "From what I've seen, [the staff councils are] working very, very well." Klausner is reluctant to use pejorative terms to describe the condition NCI was in when he took over. "It's administratively complex," he says carefully in an interview with The Scientist. "The institute was working. I didn't think it was working in the best possible way." Most of the changes announced follow the blueprint in Klausner's 1992 report on intramural research at NIH he made to former NIH director Bernadine Healy when he was director of the Cell Biology and Metabolism Branch of the National Institute of Child Health and Human Development (NICHD). Similar suggestions later were made in the Bishop-Calabresi report, in which Klausner participated. PRINCIPAL INVESTIGATOR: NIH director Harold Varmus maintains his own lab at NCI and is its sole PI. The restructuring was made with the blessing of Varmus, who quietly sat behind Klausner for a short time during the NCAB meeting. "Varmus appeared at the NCAB meeting just to physically lend his stature to Rick at NCI," says an NIH official who asks to remain anonymous. "It's somewhat significant to see Harold Varmus show up in such a casual way in an NCAB meeting." Some see Klausner as Varmus's personal messenger (G. Kolata, New York Times, Dec. 12, 1995, page C1), but observers within and outside NCI maintain that Klausner has put his personal stamp on the proceedings, especially by taking advice from sources outside NIH. "I talked to a number of people that run different organizations, private institutions, public institutions, and businesses," Klausner tells The Scientist. He adds that he "participated in the reorganization of the National Research Council, and spoke informally to some consultants on administration and large organizational structures." Klausner's emphasis on basic research was made clear by his personal presentation to the board of the "Seattle Project," intramural research funded at an NCI "satellite," Seattle's Fred Hutchinson Cancer Research Center. This complex initiative is studying the effect of chemotherapeutic drugs on yeast cells, Saccharomyces cerevisiae, that have defective areas in the chromosome that may lead to a failure of "checkpoint pathways," pathways that should be checking that chromosomal replication in the cell is occurring properly. Klausner defined cancer "as a disease of infidelity of the transmission of the genome," explaining that cancer cells are characterized by abnormal chromosomal number or structure. This project may explicate how chemotherapies may be targeted to malfunctioning checkpoints in the genome. Such very basic research "would be extremely difficult to fund . . . for an R01 mechanism," Klausner noted. Klausner feels that NCI's basic research should be on the cutting edge and should be work that no other institution would likely support. He hammered his message home to the board: "We should not make the mistake that this institution made in the past of never funding this kind of research in yeast." 'IMPRESSED': NCAB member Pelayo Correa calls Klausner's presentation to the board "a matter of courtesy and a matter of common sense." "I think we were very well impressed," states NCAB member Pelayo Correa, professor in the department of pathology at Louisiana State University Medical Center in New Orleans. He added that Klausner was illustrating two things by making this presentation himself. One was that the board should be consulted because the research is being carried out by NCI staffers in a venue outside NCI's campus. "It's a matter of courtesy and a matter of common sense to make that kind of move with the board," Correa states. The second was that Klausner "has been very involved in this kind of cell-cycle research," according to Correa. Being this open to the board about an intramural research project also left Klausner vulnerable to criticism. A board member who asks not be identified questions the applicability of research on yeast-which is physiologically dissimilar to more evolutionarily advanced organisms-to human systems. The board member points out that even if the genetic checkpoints may be similar, other physiological phenomena may be quite different. Klausner made another announcement that risked the board's criticism and surprised many NCAB members because they were not apprised of the decision beforehand. NCI placed a recent CRADA (Cooperative Research and Development Agreement) announcement in the Federal Register looking for a partner to serve as publisher of the Journal of the National Cancer Institute (JNCI), NCI's prestigious cancer journal. Klausner explained that NCI now must live within "limited resources," and needs to look at potential sources of income and to stem expenses. JNCI costs some $1.7 million annually to produce and supports 16 full-time employees. "We knew they were planning to study the JNCI's future," comments Correa. "It was a surprise for me. We really didn't have time to react." "Maybe they can save some money," muses NCAB member Kenneth Chan, professor of pharmaceutics, pharmaceutical chemistry, and internal medicine at the Ohio State University Comprehensive Cancer Center in Columbus. Chan's chief concern is that the journal be well run, and be kept alive. Correa believes the journal will be attractive to outside publishers: "When a journal is very accredited, then it has the potential of making money. It's not making money now [under NCI]." Although mechanisms that would allow an outside publisher to take charge of JNCI have yet to be worked out, Correa sees that removing this expense from the budget will allow more money to be put into research. NCI dropped its Cancer Treatment Reports and revitalized JNCI when Vincent De Vita, Jr., now director of the Yale Cancer Center, was NCI director. "We took a lot of gas [from the board for] changing [JNCI]," De Vita recalls. But he isn't upset over the prospect of JNCI's going out on a CRADA. "I think one has to examine all the kinds of possibilities," he says, adding that "there's always been this undercurrent" of criticism questioning whether the government should be publishing a journal. All of these changes, which were introduced fast and furiously, hardly giving spectators time to grasp the new acronyms, are definitely not the end of the revamping, and some individuals would like to see significantly more changes. In fact, preventive medicine specialist Armin D. Weinberg of Baylor College of Medicine's Center for Cancer Control Research sees the reorganization as a chance for NCI to exert itself in the field of application of the results of cancer research-a direction somewhat at odds with Klausner's basic science inclination. "Who," Weinberg asks, "is out there for the application?" One major opportunity is to infuse new blood into the administrative system. Four of the seven divisional director slots and numerous branch and section chief slots are vacant. These vacancies have occurred, according to Sondik, because of a combination of the increased number of divisions and the loss of divisional directors prior to the reorganization. NCI is embarking on a search to fill these vacancies and, Klausner says, "will try very hard to make sure the searches that we do are open and seek out opportunities for people from all components of society." Such an effort would be very welcome in some quarters, as many complain that the culture of NCI has been predominantly white and male. At the same time, Klausner intimates that "history and societal components" may be mitigating factors in finding minorities in fields in which historically there have been few. Brown disputes this, saying there is no "paucity of minorities who could be enticed into leadership roles and research roles" at NCI. She adds, however, that "NCI can do more to accrue and retain minority scientists. There is a culture there [at NCI] that is not very inviting [to minorities]." Weinberg and Lovell Jones are cofounders of the Intercultural Cancer Council, an organization advocating that progress in cancer research and treatment be made available to underserved communities through heightened participation in clinical trials, increased say in research objectives, and greater access to the latest treatments and technologies. Jones, director of the department of experimental gynecology and endocrinology at the M.D. Anderson Cancer Center in Houston, also disagrees that numbers of minority scientists are low. "If you don't look in the right places, you will miss those who do exist," he points out. "Everyone assumes that this is a level playing field and that all they have to put forth is to be inclusive. It is not a level playing field." Jones would like to see more training programs to increase numbers of minorities in the field, and Klausner agrees that NCI can aid the younger generation by making entry-level positions for all individuals to enter biomedical research. Weinberg and Brown both are concerned that information needs to be translated from basic research to information for the public. "I welcome opening up the NCI so that the public at large will understand exactly what the NCI's role is," says Brown. She adds that even she, a member of NCAB, has difficulty obtaining information from NCI. "There are many layers of bureaucracy that I encounter just to get an answer from the NCI." Some fear that the success of changes that are being made or are planned in the NCI reorganization rely too heavily upon Klausner's ebullient, open, and decisive personality (as well as other political capital gained) in the director's position. Weinberg states that "the changes should not be as dependent on one person as they had in the past or could be." Klausner admits, "It would be a problem no matter what structure you have. There is no such thing as setting up the structure of an organization independent of the people" who are in it. But he is hopeful that the "participatory advisory system," with internal individuals on internal advisory boards, "will outlive me." There is controlled optimism in the trenches. An NIH researcher who asks to remain anonymous, while cautioning that the reorganization cannot be an act of merely relabeling, says: "If anyone can do it, Rick can do it." Myrna E. Watanabe is a science writer based in Yonkers, N.Y.

NCI's Reorganization, Director Scrutinized By Cancer Board

Myrna Watanabe

Jan 7, 1996

NCI's Reorganization, Director Scrutinized By Cancer Board