NCAB COOL TOWARD CCOP BUT STOPS SHORT OF HALTING IMPLEMENTATION
The National Cancer Advisory Board displayed some coolness toward the new Community Clinical Oncology Program along with a reluctance to interfere with its implementation when the Assn. of Community Cancer Centers and Assn. of American Cancer Institutes made presentations at the Board’s annual program review last week.
The Board expressed somewhat warmer feelings toward cancer centers in general, but dropped warnings that center core grant support should not be taken for granted nor considered a permanent institution.
Presentations were made by Herbert Kerman, ACCC president; and Richard Steckel, AACI president, assisted by Peter Magee, Gerald Murphy, Joseph Cullen, and Palmer Saunders.
Kerman described elements of community hospital cancer programs, many of which have been established with encouragement and advice of ACCC and mostly without federal funds. He also described COOP, which will be funded in part by NCI’s Div. of Resources, Centers & Community Activities with the primary mission of making more research protocols available to cancer patients at. the community level while also bringing more community patients into clinical trials.
“I congratulate you on developing your own programs at a time when the President is encouraging self support,” Board member Janet Rowley said. “Isn’t there enough interest among other communities to develop their own programs so that this can be an area where federal money is not required?”
Kerman responded that federal funding requirements for CCOP “is minimal. If we are going to participate in clinical trials, some funding is required. There is no source of money to pay for clinical trials other than the federal government.”
“But you are doing it on your own,” Rowley said, referring to the program at Kerman’s Halifax Hospital in Daytona Beach.
“No, the cost of the tumor registry is included in patient fees,” Kerman said. “Patient fees and third party payers are the only source of revenue.” Most of the money from NCI to support CCOP will pay for data collection and analysis and other costs required for clinical trials.
“For nominal federal funding (an estimated $10 million a year for maximum 10,000 patients entered into trials by an ultimate 200 participating hospitals) . . . this will add a tremendous resource for a new level in the Cancer Program,” Kerman said. “This should have high priority, not a lesser one.”
Board member Harold Amos asked how the community physician would fit into the program . “I’m glad you brought that up,” Kerman said. “The community physician will remain in control of the patient . When I as a radiotherapist accept a referral from a family physician, I as a consultant treat the patient, and bring in others as required in a team approach. But that patient stays under the care of the original physician.”
Kerman said that tumor conferences and other education efforts provided by his cancer program are well attended by family physicians.
“Are you willing to say that the level of understanding of cancer treatment has increased as the result of your efforts?” Amos asked.
“No question,” Kerman replied.
Board member Rose Kushner expressed concern about “combination chemotherapy being used too indiscriminately,” although acknowledging that “most breast cancer patients want to be treated at home.”
Kushner picked up on the argument by some of those. interested in the Cancer Control Program that funds earmarked by Congress for cancer control will be used to help finance COOP. “I would like to have a ruling from the HHS general counsel on whether cancer control money can legally be used for experimental therapy,” Kushner said.
“We’ve been doing research with cancer control funds for six years,” Director Vincent DeVita said, referring to the cooperative group cancer control program which costs about $5 million a year and will be phased out as the CCOPs are funded. “If it’s illegal, we’re already in trouble. The stipulation that no control money be used to support research is an NCI policy, and it came from the feeling that cancer control money should not be used to fund grants.” Because it is an NCI policy, it can be changed by NCI without consulting HHS, DeVita indicated .
Kushner insisted that the involvement of the Div. of Cancer Treatment required to implement and manage CCOP should involve some DCT support for the program. “If there is cross division responsibility, there should be cross division funding.”
“It all comes from the same pot,” DeVita said.
“No, cancer control money going to CCOPs is not going to cancer control activities,” Kushner said.
Rowley wondered “if it is appropriate to support this at all in light of the budget problem. Some feel there are enough centers.” Rowley objected to what she said was the “fait accompli that there are going to be CCOPs and the only question is the mechanism (contract, grant, or cooperative agreement) . There is a central premise here that has not received review.”
“Our Board (of Scientific Counselors of DRCCA) did a good part of the development of the program,” DRCCA Director Peter Greenwald said.
“They have a vested interest in it,” Rowley said.
“No, there are mixed interests on that Board,” DeVita said.
“It is essentially done, and I don’t think anything short of action we’re not prepared to take will stop it,” Amos said.
“CCOP has been rammed through without enough thought,” Kushner said. “Others feel as I do, we’re uncomfortable with it. It is not too late.”
“I take the responsibility for moving fast,” DeVita said. “I have never seen any reason for moving slow. A lot of thought by the (DRCCA Board) committee has gone into it . We have to move quickly to get chemoprevention trials going. We will have a terrible time defending the Cancer Control Program, and if we want to save that budget we will have to move fast.”
DeVita suggested that “if this Board (NCAB) is going to be involved in these decisions, you better move fast.”
The Board adjourned without making any recommendation. The DRCCA Board will meet in January, with final approval of the COOP guidelines on the agenda.
“One of the biggest problems of hospitals trying to gear up for clinical trials is identifying patients which fit the criteria,” Board member Maureen Henderson said.
“The number of those eligible is always smaller than hospitals think. You have to accumulate a minimum number for a particular cancer site. Can a group of hospitals come to an agreement which will concentrate patients at a particular hospital?”
Kerman said that an estimated 10 percent of patients will fit into protocol requirements . “Most major hospitals can provide the minimum 50 patients (which will be required of participating CCOPs).”
Board member Robert Hickey pointed out that patients with rare tumors “should be concentrated in centers.”
“We are aware at our institution of the special interests of other institutions,” Kerman said. “There is a hospital in Gainesville which has a special interest in extremity sarcomas, and we refer all of ours to them.”
In the “best of all worlds,” DeVita said, COOP will “increase referrals to centers and at the same time increase the number of patients in clinical trials.”
DeVita repeated his intention of placing control of Group C drug distribution in the hands of COOP participating institutions once the network has been established. Group C drugs are those which have been proven useful against one or more tumors but are not available commercially. NCI supplies those drugs free to physicians who register with NCI and FDA and agree to certain reporting requirements.
AACI includes in its membership nearly all of the cancer centers in the U.S. and many of those elsewhere.
Magee described basic research activities in cancer centers and the importance of that research to developments in treatment, radiotherapy, chemotherapy, immunology, and prevention.
Rowley commented on “the impact of the problem with funding individual research grants .” Support for RO1s is declining as the priority score payline has declined, she said. Magee agreed that the impact “will be considerable in the near future.”
“There are two sources for funding investigators in centers, the core grant and RO1,” Rowley said. “We need stability in funding both. Unfortunately, they are often seen as competitive. There is the feeling that the more that goes into core, the less there is for R01s.”
“I would vigorously contest the concept that core is competitive with RO1s or PO1s,” Steckel said.
Magee pointed out that salaries may be paid from core grants only for those investigators who have RO1s or PO1s (except for those who may be between grants, developing new proposals, or are new investigators).
Amos asked about the influence of clinical research on basic research. Magee replied that Baruch Blumberg, who won the Nobel Prize for his work which has led to development of a hepatitis vaccine, “was enormously influenced by his clinical experience.”
“Bringing clinical and basic research together in a center, in theory, each enhances the other,” Amos said. “Is this true?”
“There is no question,” Steckel said. “The influence is quite dramatic.”
Murphy described various clinical research activities carried on by cancer centers, noting that major advanced in nearly all modalities either originated in or were carried through to implementation in centers. Most major clinical centers participate in cooperative group clinical trials and also carry out phase 1 and 2, combination, and adjuvant chemotherapy studies.
Board member William Powers said that “at least a significant portion of clinical centers have registries and collect data for assessment of results of therapeutic research. Are those data available?”
Murphy said that the Cancer Center Patient Data System makes those results directly available to all centers and through the International Cancer Research Data Bank to others. The American College of Surgeons supports a program for data compilation, Murphy said.
Murphy referred to the construction and renovation program supported by NCI which has been of major importance to many centers. That program has generated three to four dollars for every NCI dollar, Murphy said.
Steckel returned the discussion to core grants, which he said “is the glue which holds the research efforts of a center together. . . . It has been implied that core grants compete with RO 1 s and PO 1 s. Almost all costs (shared resources, administrative costs, investigator salaries) would be borne by RO1s and PO1s if there were no core grants They are complementary to each other. I would emphasize that core gran s are rigorously peer reviewed every three or five years, and they are based on the existence of peer reviewed RO1 and POI grants .”
Steckel cited several issues relating to centers. “Can a means be found to support core grants at recommended levels? This is not a criticism, because I am aware of the budget problems. But core grants are being supported at less than recommended levels . Is there an optimal number of institutions which can be supported through core? Is there a geographical limit? Or should there be no limit at all on the number or geographic distribution. Can review of core be improved?” Steckel said AACI supports the new guidelines for core grants, agonizingly developed over nearly four years, which places limits on the size of the grants, and on support of professional salaries . Those limits are “absolutely essential,” he said.
Board member Gale Katterhagen asked if AACI has addressed itself to the issue, if major cuts have to be made in the NCI budget, of whether reductions should be applied across the board to all core grants or should some be left unfunded to support fuller funding for the others.
Steckel said AACI has no present position on budget reductions. “That is a major issue. If you let some fall off, we stand to lose the major investment we have in those institutions. My personal view is that peer review should be respected. Fund at full levels, even if that means letting the bottom go unfunded . But I would ask that liberal phase out periods be offered.”
“That may not be realistic,” Board Chairman Henry Pitot said.
“We are facing a cut,” DeVita said. “Basically, we are giving phase outs to those below the paylines. . . . Study sections are recommending increases of 20 to 40 percent, and that is not realistic when the institute’s budget is going down.”
Rowley insisted that core grants and RO1s “are competitive in the sense that there is a limited amount of money which NCI has. We will have to make some critical decisions on where to spend it. Can we really afford to maintain 60 centers?”
“I’m for motherhood and against sin when it pertains to quality and funding,” DeVita said. “But there is some requirement for geographic distribution. If there is some question on numbers, if we are below the optimal number, then we need to preserve the centers we have. I asked the DRCCA Board committee to look at numbers. The committee deliberated and came up with a definitive answer on core grants (that basic research centers should continue to be supported by core grants rather than some other mechanism). But it dodged the issue on geographic distribution and numbers. I don’t know what to do if centers all have scores in the acceptable range. If some are way below the payline, we should encourage more to come in. Even in times of restricted budgets, I’m a believer in going ahead with things we need the most.”
“Has AACI addressed the problem of an apparent glut in the number of medical oncologists?” Board member Gale Katterhagen asked. Steckel responded that it had not.
Saunders, dean of the Univ. of Texas at Galveston Graduate School of Biomedical Sciences, was director of what is now the Div. of Extramural Activities when the centers program was started in the 1960s. Steckel asked him to participate in the AACI presentation.
“One of the prerogatives of a senior citizen is indulging in glittering generalities,” Saunders said . “The cancer center is the catalyst for new knowledge in basic research. Every center which has received a favorable review by NCI has doubled the number of RO1 grants at its institution. No new treatment can come about without basic research developments.”
Saunders said he was “grateful that I don’t have Vince’s problem in wrestling with budgets.” On the issue of numbers, “I think there must be cancer centers available to the majority of the U.S. population. We can’t afford four or five in one geographic area when there are vast stretches of the country where there are none. But I don’t know what the number should be.”
“Some of us are strongly supportive of comprehensive centers,” Amos said. “I’m convinced they are doing some unique things. I don’t know how to decide on the number or distribution. I think we should encourage others. There should be no intent to support cancer centers by the federal government forever. Forever ends when a center can support itself. Finally, we have to protect the individual with an idea of his own who is without a connection to a center.”
Cullen, speaking on cancer control and its relation to centers, substantiated DeVita’s remark that the Cancer Act does not prohibit cancer control research with earmarked funds, citing sections of the Act.
Cullen cited former NCI Director John Heller’s definition of cancer control “as those efforts to close the gap between what we know and what we do.”
Prevention is an obvious cancer control activity, “but knowing risk factors is only part of a cancer prevention methodology,” Cullen said. “How those factors are perceived, whether they are accepted and acted upon by some change agent will for the most part determine the eventual cancer incidence rates. Cancer control is the judicious application of techniques to stimulate the change agents to reduce or eliminate the exposure. If these techniques are found absent or wanting, cancer control is the research and development of them.”
“. . . In the diagnosis and treatment sectors there are also opportunities for cancer control. Dr. DeVita has stated that the most serious operational problem facing NCI in the next decade is the development of a satisfactory approach for linking care at the community level to the research institutes. . . . I agree with his aspirations . . . and caveats. To establish these linkages will take time, mutual trust, and much compromise for all parties concerned.”
