CAPCAM Reviews Best Cases

CAPCAM Reviews Best Cases; Considers Efforts to Recruit CAM Practitioners into Research

In: Complementary & Alternative Medicine at the NIH , Fall 2000 newsletter, Volume VII, Number 4, page 5. See Minutes of the meeting for details.

The Cancer Advisory Panel on Complementary and Alternative Medicine (CAPCAM) met on September 18 in Bethesda, MD, to hear from Steve SGAs, M.D., [sic. -- should be SGA] and Donato Perez Garcia, M.D., on their experience with insulin potentiation therapy (IPT) plus chemotherapy for cancer patients.

As part of the National Cancer Institute's (NCI's) Best Case Series program, Drs. SGAs and Perez Garcia presented three cases in detail, including two about patients with breast cancer. The IPT approach uses intravenous injection of insulin followed by intravenous injection of standard anti-cancer medications in lower doses than ordinarily used in conventional medicine.

Proponents of IPT have not identified the specific mechanism of action, but they believe it may work in the following ways:

	Making cell membranes and tissues more permeable, allowing more uptake of the chemotherapeutic drugs;
	Selectively delivering chemotherapy drugs to cancer cells; and
	Modifying cell metabolism to make cancer cells more susceptible to drugs.

If IPT is found to be at least as effective as current conventional treatment, it would be considered an improved therapy. This is because lower doses of chemotherapy drugs result in fewer side effects, which would at the very least improve the quality of life for patients undergoing cancer treatment. Proponents of IPT also believe it might even drive cancer into remission.

Panel members generally agreed that the cases were interesting, but many factors made it hard for them to fully evaluate the treatment. The Panel proposed that Dr. SGAs prospectively identify patients to be treated and plan to present the results of treatment for selected patients from that group. Members emphasized that the goal was not to perform a formal study but rather to identify patients to be carefully monitored for the purpose of presenting an expanded series of Best Cases to the Panel.

More Outreach Efforts Needed

The Panel's recommendation led to a discussion about the need for the NCI, its Office of Cancer Complementary and Alternative Medicine (OCCAM), or CAPCAM to devise a way to help practitioners like Dr. SGAs gather data more effectively. There seemed to be consensus that many complementary and alternative medicine (CAM) practitioners have little experience conducting rigorous research and are unfamiliar with the methods of gathering and presenting data in a formal manner, nor do they have the time or money to spend to do so.

Mary Ann Richardson, M.P.H., Dr.P.H., program officer for the National Center for Complementary and Alternative Medicine (NCCAM), said the University of Texas Center for Alternative Medicine Research in Cancer, which she established and directed, made significant efforts to seek out CAM practitioners and help them gather data. She also noted that all the NCCAM-funded centers are required to make a commitment to reach out and address similar problems. The Panel agreed such efforts must continue.

Difficulty gathering sufficient data on patients may be one reason NCI's Best Case Series program for CAM has not yet yielded a great deal of submissions suitable for review. In response to this setback, panelist Ian Coulter, Ph.D., a research professor and consultant to the RAND Corporation, explained his organization's methods of researching CAM practices.

The RAND Corporation's approach begins with an extensive review of published literature on a specific topic that includes evaluating the relative quality of each piece of published research, then making a determination of the overall quality of the evidence. Dr. Coulter suggested that the Panel identify members or staff who would be willing to do custom literature searches and reviews to identify promising areas of CAM cancer treatment. Members agreed that a literature review also would help inform the Panel about the current status of various therapies, perhaps leading the group to invite specific individuals to present their own Best Case Series.

The RAND Corporation also performs practice-based studies that involve randomly selecting practitioners, sending staff to practitioners' offices to randomize and abstract patient files, surveying patients, and evaluating the results. Dr. Coulter recalled that a recent study of chiropractic for low back pain involved six abstractors doing onsite evaluations for 1 year plus four fulltime investigators working throughout the 3-year duration of the project.

Dr. Coulter said the RAND Corporation overcame the biggest hurdle--mistrust from the chiropractic community--by developing relationships with leaders in the field and assuring them that the Corporation would work aggressively to see that the results of the study were not misinterpreted or reported out of context by the media. He emphasized that CAM practitioners have tremendous mistrust of the conventional medical research model. "Many of these practitioners have been labeled as quacks, and they have good reason to be suspicious of research. We cannot ignore that," said Dr. Coulter. However, he also noted that as a result of RAND Corporate staff visiting individual practices and evaluating charts on site, many practitioners gained a better understanding of and comfort with the research process.

Panel members agreed the practice-based approach would be ideal, but the NCI and the NCCAM will have to consider the resources to undertake such an effort. Dr. Coulter emphasized what the Panel had already identified: that any outreach efforts to educate CAM practitioners on how to better record, collect, and present data would help improve both the number and quality of Best Case presentations to the Panel.

NCCAM Update: More Cancer Studies Under Way

Dr. Richardson presented an update of NCCAM's efforts related to cancer, including two newly funded centers: the Center for Cancer Complementary Medicine at Johns Hopkins University and the Specialized Center of Research in Hyperbaric Oxygen Therapy at the University of Pennsylvania. Research efforts at the Johns Hopkins Center address such diverse CAM cancer treatments as PC SPES (a combination herbal preparation), soy phytoestrogens, tart cherry, and prayer. At the University of Pennsylvania, investigators will look at physiologic effects of hyperbaric oxygen, including angiogenesis, vascular integrity, and cell adhesion.

Other cancer-related studies under way address green tea, black cohosh, soy supplements, shark cartilage, and distant healing, among other methods. Dr. Richardson also reported that the NCCAM Advisory Panel recently approved two new concepts for potential study: CAM for end-of-life care and phytoestrogens for breast cancer.

OCCAM Raises Awareness

Jeffrey White, M.D., Director of NCI's OCCAM, gave an update on OCCAM's efforts to increase awareness of CAM cancer approaches and the Best Case Series program. He reported that the NCI has collaborated with the NCCAM to develop more fact sheets on CAM for cancer and that the number of research summaries on CAM treatments now in NCI's Physician Data Query (PDQ) database has increased threefold since the last CAPCAM meeting.

Dr. White's intense campaign to promote the Best Case Series has included direct mail invitations, presentations at conventional and CAM conferences, advertising and news coverage in CAM-related journals, and redesign of the OCCAM Web site. He said the number of inquiries he's received about the program has doubled over the past year; the number of submissions is also increasing. NCI recently agreed to pay travel expenses for practitioners presenting cases before the Panel and is exploring the feasibility of reimbursing practitioners for the expenses incurred in preparing a Best Case Series for the panel. The Panel applauded Dr. White for his diligent efforts.

In his closing remarks, Stephen E. Straus, M.D., NCCAM's Director, praised the initiatives taken so far to encourage CAM practitioners to present data. However, he also expressed some disappointment with the pace of efforts to identify promising CAM cancer treatments for further study. "We won't know for a few years whether we've been successful, but I'm optimistic," he said. Dr. Straus told the Panel, "I commend you and I challenge you to continue to be as optimistic and as collegial as you've been."