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Back to: About NCCAM: CAPCAM: Minutes

Minutes of the First Meeting - July 8-9, 1999

Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM)

On this page

  1. Call to Order and Meeting Procedures
  2. Introduction of Members
  3. Review of Confidentiality and Conflict of Interest
  4. Future Meeting Dates
  5. Introductory Remarks - Dr. William Harlan, Acting Director, NCCAM
  6. Introductory Remarks - Dr. Jeffrey White, Director, Office of Cancer Complementary and Alternative Medicine, NCI
  7. Introductory Remarks - Dr. Ernst L. Wynder, Chairperson, CAPCAM
  8. Introduction to Best Case Series - Dr. Jeffery White
  9. Best Case Series Presentation: Homeopathic Treatment of Cancer - Drs. Pransata and Pratip Banerji, BPHRF
  10. Phase I/II Study of Stage III and IV Non-Small Cell Lung Cancer Patients Taking a Specific Dietary Supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer
  11. Discussion
  12. Concept Review of Best Case Series Presentation: Homeopathic Treatment of Cancer
  13. Review of the CAPCAM Process
  14. Public Comment - Ann E. Fonfa, The Annie Appleseed Project
  15. Adjournment

CAPCAM Members Present

  • Michael Hawkins, M.D., Co-Chair
  • Thomas Brown, M.D.
  • Edward Chapman, M.D.
  • Peter L. Choyke, M.D.
  • Ian D. Coulter, M.D.
  • Susan S. Ellenberg, Ph.D.
  • William R. Fair, M.D.
  • James S. Gordon, M.D.
  • Mitchell R. Hammer, Ph.D.
  • David J. Hufford, Ph.D.
  • Frances A. Jacobs, R.N.
  • Konrad Kail, M.D.
  • Sheila Moriber Katz, M.D.
  • Douglas L. Weed, M.D., Ph.D.
  • Lauren V. Wood, M.D.
  • Jeffrey D. White, M.D., Director, Office of Cancer Complementary and Alternative Medicine (OCCAM), NCI - CAPCAM Ex Officio Member

NCCAM Staff Present

  • William Harlan, M.D., Acting Director, NCCAM, NIH
  • Doug Hussey, NCCAM, NIH
  • Richard Nahin, M.P.H., Ph.D., NCCAM, NIH

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Others Present

  • Dr. Pratip Banerji, PBHRF
  • Dr. Prasanta, PBHRF
  • Dr. Alexander Sun, Ph.D., Medical Director, Connecticut Institute of Aging and Cancer
  • Mr. Ted Cron, Cron Communications
  • Dr. T.M. Fasy, Mount Sinai School of Medicine
  • Mr. Norman Fu, China Times
  • Mr. Tom Garvey, Esq., FDA
  • Ms. Liz Genski, Capitol Associates for NNFA
  • Ms. Freddie Ann Hoffman, FDA
  • Ms. Susan Holloran, National Center for Complementary and Alternative Medicine Advisory
  • Mr. Amir Jahangir, American Cancer Society
  • Dr. Wayne Jonas, USUHS
  • Ms. Joann Miron, FDA
  • Mr. Leo Moody, HRSA, BPHC
  • Mr. Michael Odone, Myelin Project
  • Mr. James O'Leary, FDA
  • Mr. George Persinas, Washington Insight
  • Dr. M.A. Richardson, University of Texas
  • Ms. Rebecca Spieler, The Blue Sheet
  • Ms. Deb Stein, Capitol Associates
  • Mr. Le-Hai Wang, Mount Sinai School of Medicine

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I. Call to Order and Meeting Procedures

The meeting was called to order at 8:30 a..m. by Dr. Richard Nahin, following a video presentation designed to familiarize CAPCAM members with their responsibilities as designated Federal officials serving on this committee. Dr. Nahin pointed out specific procedures the committee must abide by now that the CAPCAM is an officially chartered Federal committee. First, the committee must comply with Freedom of Information Act (FOIA) rules that govern disclosure of CAPCAM work to the public and set guidelines for which meetings should be open to the public, and CAPCAM must advertise public meetings as appropriate. Second, committee members are designated Federal officials and must abide by Federal ethics rules. Finally, CAPCAM is charged with providing concept clearance for any initiative-based research resulting from presentations to CAPCAM. Dr. Nahin said that while panel members are expected to develop consensus statements regarding how to proceed with specific research proposals, minority opinions will be taken into consideration as well. The task of CAPCAM panel members is to listen carefully to the presentations and then to make one of the following determinations:

Enough data has been presented to warrant further research.

The data presented indicates that no further research is warranted.

The data is insufficient to make a determination. In this case, the panel members should, if possible, indicate desirable steps or actions to take so that the investigators can present their cases again. Once preliminary data indicate that further research is warranted, the role of the CAPCAM panel is to determine (1) scientific significance of the proposed concept; (2) the feasibility of conducting the research (i.e., sufficient patient population and adequate resources exist); (3) the final outcomes for evaluation (e.g., survival, quality of life); and (4) concept relevance to the NCCAM or NCI portfolios. Dr. Nahin explained that the best case series portion of today's session is closed to the public to protect patient confidentiality, but that a discussion on that portion would be conducted in open session tomorrow. He told CAPCAM members that Dr. Jeffrey White would discuss how the two research presentations came to the attention of OCCAM. He also said that CAPCAM members are expected to function as the "eyes and ears" for what is happening on the cutting edge of CAM research. Future presenters are likely to come from: (1) current or past NIH grantees; (2) current Centers for Disease Control (CDC) assessments; (3) the Agency for Health Care Policy and Research (AHCPR); and (4) collaboration with NIH-sponsored clinical trials already being done in conventional medicine (if appropriate, an arm incorporating a CAM component could be added to an existing study).

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II. Introduction of Members

The participants introduced themselves, explained what they do, and told the panel what specific areas of expertise they lend to CAPCAM.

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III. Review of Confidentiality and Conflict of Interest

Dr. Nahin told CAPCAM members that a conflict of interest may occur when any of the following exist: (1) the member has a designated role in the research as the principal researcher or a subject of the research; (2) the member has a self-interest-professional or financial-in the research results; (3) there is even an appearance of conflict stemming from participation of a family member or someone the CAPCAM member knows. If any of these conditions is present, Dr. Nahin said, the CAPCAM member must withdraw from the discussion to prevent the proceedings from having an appearance of bias. Dr. Nahin instructed members to refrain from discussing meeting topics outside the forum of CAPCAM meetings. Private discussions about CAPCAM topics should be conducted only between a committee member and a member of the NIH staff, not with a researcher or anyone else, he said. Furthermore, committee members must not keep any materials distributed in a closed session. These materials must be left with Dr. White since they contain confidential information. Industry representatives should be referred directly to Dr. Nahin or Dr. White. A breach of confidentiality could preclude a CAPCAM member from future participation, and each CAPCAM member must sign a confidentiality agreement. Previously, most research investigations of CAM were invisible to NIH; that is, CAM research was not being brought forward and seriously considered. CAPCAM acts as a forum where CAM practitioners and investigators can be heard. It is one possible entry point into NIH. As such, CAPCAM serves as a forum in which ideas can be generated and explored.

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IV. Future Meeting Dates

Dr. Nahin said the next CAPCAM meeting is tentatively scheduled for Monday, December 13, 1999.

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V. Introductory Remarks - Dr. William Harlan, Acting Director, NCCAM

Dr. William Harlan clarified "concept clearance." He said it is a way for an NIH committee, such as CAPCAM, to look at research before it becomes an initiative. However, CAPCAM does not review grant applications. The concept is generated within one of the advisory committees. These must address the following questions: (1) is concept a reasonable approach; and (2) if yes, should an initiative be developed that would lead to further investigation? Committees must determine whether there is sufficient basis to initiate a clinical trial or whether there is insufficient information. Dr. Harlan said the community of CAM practitioners requires a liaison such as CAPCAM to help bring their work forward, and several committee members concurred.

Dr. Harlan said that Dr.White plays a critical role in identifying data and has done a superlative job, making it likely that Dr. White's office will see more and more cases as people realize that it is a good access point. The critical role of CAPCAM will be to determine what should be studied and what should not. A challenge, one member said, will be to ensure the same objectives are consistently applied by all review groups. The committee also discussed the role of Institutional Review Boards (IRBs) in assuring the protection of human subjects in CAM therapies research.

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VI. Introductory Remarks - Dr. Jeffrey White, Director, Office of Cancer Complementary and Alternative Medicine, NCI

Dr. White presented an overview of OCCAM, a small coordinating office with a staff of three people. OCCAM serves the following functions: (1) it serves as the NCI's liaison to NCCAM; (2) it develops NCI's CAM agenda; and (3) interfaces with the public, the CAM community, and the oncology community regarding CAM cancer research. As part of its mission, the office will have a web site by the fall 99. In response to a question from Dr. Michael Hawkins, Dr. White said his office anticipated being able to present about two to three best case series per CAPCAM meeting (or 6 to 9 per year). Dr. White asked committee members for feedback on ongoing CAM cancer studies, including: (1) a Phase III clinical trial of oral shark cartilage in patients with cancer; (2) an evaluation of intensive pancreatic proteolytic enzyme therapy with ancillary nutritional support in the treatment of inoperable pancreatic adenocarcinoma; (3) work being conducted at the University of Texas Center for Alternative Medicine; and (4) an NIH RFA for the Center for Complementary and Alternative Medicine Research. He reported that a meeting had recently been held in Crystal City, Virginia, on the subject of integrating CAM therapies into comprehensive cancer care, and that he would like to see CAPCAM involved in that meeting next year. Applications in response to an initiative for centers for mind-body interaction, is under review now. It would provide $1.5 million for studies at six centers. In closing, Dr. White asked CAPCAM members to urge others in the field to bring their best case series before the group.

The committee reviewed and approved the minutes of the November 16, 1998, meeting.

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VII. Introductory Remarks - Dr. Ernst L. Wynder, Chairperson, CAPCAM

(Dr. Wynder, was unable to attend the meeting, but his written remarks were read by Dr. Nahin) - Dr. Michael Hawkins, Co-Chairperson, CAPCAM)

Dr. Ernst Wynder said it is time for CAM practitioners to establish what should to be expected for complementary and alternative medicine. He proposed five areas for action:

Evaluate data using the scientific method; however, it would be easiest to study CAM modalities as an adjunct, because a clinical trial presents many problems.

Consider quality of life when testing CAM treatments in cancers with high mortality. The three hard end points of therapy are tumor response, disease-free survival, and survival itself, but quality of life can be improved as well.

Establish an information network for CAM for which all potential sources of study results are pursued and through which appropriate information is routinely disseminated to the medical and lay public.

Consider laboratory research an essential part of establishing CAM's merit. The total agent as well as its specific components must be tested. The question, of course, is always whether the identification of a single factor can be expected to make appropriate use of the whole compound.

Consider epidemiological techniques to give support, or lack of it, to an agent. Dr. Wynder charged the committee with producing a document against which CAM's can be evaluated and urged the committee members to move forward with this work.

Dr. Michael Hawkins praised Dr. Wynder for having "a great feel for why we are here and what kind of focus we should have." He praised Dr. White for his work. Having complete data at the time of review is the best use of the committee's time, he said, and Dr. White's work has been so thorough that the committee can trust it as it is, without spending further time on inquiries.

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VIII. Introduction to Best Case Series - Dr. Jeffery White

Before introducing the best case series, Dr. White told the committee that his office has produced a small brochure with a form on the back that asks practitioners to detail what they are doing in CAM and how their projects are being funded. The same information will be on his office's web site in the fall. Dr. White detailed the steps a practitioner should follow to bring a best case series forward. The steps in operation since 1991 at NCI are changing with CAPCAM's participation. Steps include: (1) a practitioner contacts NCCAM or NCI; (2) OCCAM coordinates the process of obtaining materials for review; (3) OCCAM conducts an internal review and writes a summary; (4) OCCAM distributes a summary to CAPCAM committee members prior to each scheduled CAP meeting; (5) the practitioner presents materials and answers questions from the panel; and (6) the panel returns to the practitioner its assessment of the significance of the results of the best case series and a statement of its recommendation for further research, if any.

Dr. White detailed the elements of a case report form and the best case series process. Following a best case series presentation, potential next research steps include: (1) prospective observational studies; (2) early phase-I and II-clinical trials; (3) prospective clinical trials; and (4) basic research on the potential mechanism of action. Phase II trials, Dr. White explained, generally use an established dose and establish a response rate. Phase III trials are generally randomized studies that compare a new agent with an established agent. The most common problems with patient information submitted for best case series are: (1) no documented diagnosis; (2) subjective endpoints (rather than documented shrinkage of a tumor); (3) short follow-up; (4) concurrent and/or previous standard cancer therapy; and (5) missing data.

The committee then discussed the difficulties of conducting conventional clinical trials to determine the efficacy of CAM treatments. Dr. White emphasized that the problem with concurrent conventional therapies is significant, and that the scientific community prefers to see no confounding factors like chemotherapy. Dr. Konrad Kail said there are almost no cases where conventional therapy is not used; he stressed that it is almost unethical not to use both approaches simultaneously. Another panelist said this may not be as true in India and other countries. It was later explained that if a researcher can address an issue as a unique population or unique research, NIH can fund projects overseas. Dr. Hawkins said this is often a problem with best case series documentation. He suggested that practitioners may want to do a relatively small randomized trial. In that case, he said, the data collection is not particularly onerous for the practitioner. If a practitioner believes a particular agent is effective in the treatment of cancer, conducting a prospective data collection on the next group of patients would qualify as an individual trial. He said that this task may have seemed onerous to many CAM practitioners in 1991, so the best case series was introduced then to avoid intimidating them. But perhaps this approach is not as necessary as it once was, he said. The paradigm for conventional research is a pilot study of 30 or 50 patients, with a report on the response rates and toxicity, and if the CAM community can get to this point, a best case series becomes unnecessary.

Dr. Edward Chapman pointed out that some alternative therapies, such as homeopathy, do not look at a single agent. Homeopathists individualize treatment specifically for each patient. Dr. Douglas Weed suggested that best case series results ought to be replicated by another practitioner to get a sense of universality. Drs. Kail and Chapman raised the issue of informed consent, which varies from state to state because it is legislated at the state level. Dr. Lauren Wood asked whether there is basic benchmark data on alternative medicines already in use; after some discussion, Dr. Sheila Katz asked that the committee members receive background information on other groups that have addressed these topics.

Dr. Weed raised the issue of numerators and denominators in clinical trials. The denominator issue is of paramount importance, he pointed out, showing whether an agent worked in 10 out of 10 patients or 10 out of 1 million. But, he said, the numerator is important as well: in either case, the agent worked in 10 patients, regardless of whether 10 were in the study or 1 million. If the numerator isn't there, the results are not significant, he said. Dr. David Hufford said that some CAM therapies may prove to be very effective on a small subset of the population. In the case of CAM, it's important to look at the numerators. Dr. Kail touched on another point that sets CAM therapies apart from conventional medicine: Conventional treatment addresses only tumor shrinkage, but alternative medicine focuses on other factors such as better liver function and the growth of certain cell populations. Members of the group expressed an interest in seeing research that addresses quality-of-life and "soft data." Dr. Wood asked if there is a general sense about CAM practitioners' willingness to embrace research for legitimacy and recognition. Or, she wondered, is there a general reluctance on the part of CAM practitioners to come under scientific scrutiny? Dr. Kail told her that there is a little bit of both. Offices with small staffs can't even look at the prospective data in their own offices and are likely to wish to avoid coming under too-close scrutiny. Individuals with a specific therapy that seems to work-a small group, he stressed -will come forward, but most funding will be sought by institutions. Dr. White asked panel members to identify publications that CAM practitioners with promising modalities might read or other ways to reach this group through advertising. Dr. Weed suggested that a pre-meeting workshop at a national meeting might give some CAM practitioners the information they need to move forward into presenting a best case series or getting into a clinical trial.

The committee adjourned for lunch and convened again in closed session at 1:15 p.m.

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IX. Best Case Series Presentation: Homeopathic Treatment of Cancer - Drs. Pransata and Pratip Banerji, BPHRF

This session was closed to the public for reasons of patient confidentiality.

The committee reconvened Friday, July 9, at 8:30 a.m.

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X. Phase I/II Study of Stage III and IV Non-Small Cell Lung Cancer Patients Taking a Specific Dietary Supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer

Dr. Alexander Sun first used a combination of Chinese herbs and vegetables to treat the cancer of his mother, who was diagnosed in 1984 with non-small cell lung cancer. Despite chemotherapy and radiotherapy, the cancer grew and metastasized until it was graded as a Stage IV cancer and conventional medicine could not fight the disease. Dr. Sun, a native of Taiwan who is fluent in Chinese, found a copy of a Chinese traditional medical textbook, Chinese Medicinal Herbs, and studied it thoroughly. He learned where and how each herb grows, how to prepare it, what its properties are, whether it is toxic, and how it is used to treat disease. The book listed the right ways to use each herb, and Dr. Sun carefully analyzed all this information to prepare an herbal vegetable soup to boost his mother's immune system and shrink her tumor. When the tumor was removed surgically in December 1985, the surgeon was impressed that although it was large, it was very well encapsulated, and that there was no cancer in the margins or lymph nodes. The surgeon told Dr. Sun he had never seen this kind of encapsulation in 30 years, and said there must be something about the Chinese herbal treatment that had led to this result. Dr. Sun reported that his mother is still free of cancer 14 years later.

Dr. Sun then gave the same soup to a family friend who had three brain lesions, which subsequently shrank and then disappeared. Further research followed. The team, which grew to include a number of researchers from Mount Sinai Medical Center, tested the soup in laboratory mice and determined that it had both immune-enhancing and tumor-reducing properties. They next were invited to the Czech Republic where a study on the use of Dr. Sun's SV soup in treatment of lung cancer patients again showed favorable results. Later, many family friends were referred to the team. Their medical records were obtained, and the team viewed their pathological slides and radiological reports. Of 18 such patients, many were unable to drink the soup for two months; already they were too sick, and they died. But two Stage IV cancer patients who took the soup were in complete remission 15 months later. Seven of the patients are still alive after 60 months or longer. In many, but not all, of this group, the SV soup was used as an adjunct to surgery or other conventional modality. The primary and/or metastatic tumors of 10 of the patients were surgically removed, and eight of those patients remain cancer-free, leading Dr. Sun to believe that the SV soup and surgical removal of a tumor may be the best approach in many cases. Radiotherapy also seems helpful when used with the SV soup, he said. Dr. Sun concluded that the apparent success of his SV soup leaves many questions. Dr. Richard Fasy, a member of Dr. Sun's team, proposed a paradigm for a future 24-month clinical trial on 60 Stage IV NSCLC patients, using a randomized and double-blind design, with 30 patients receiving the active SV soup and 30 patients receiving a placebo. (Dr. Sun detailed several difficulties, however, in preparing a placebo that looks and tastes like a Chinese herbal preparation but has no active medicinal components.)

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XI. Discussion

The research team asked the panel's help in determining what its next step should be. From the discussion that followed, it became clear that Dr. Sun and his colleagues have talked with Massachusetts General Hospital, which has expressed interest in funding and conducting a 60-patient Phase III clinical trial. Further discussion led the panel to caution Dr. Sun about carefully assessing the optimum dose (small patients seem to have done better than larger patients in the earlier studies, leading Dr. Sun to wonder whether a different dose should be recommended for larger patients) and developing a true placebo. Furthermore, the panel believed that if dietary recommendations were made as well, these should be formalized as part of the Phase III study.

Dr. Fair suggested that SV soup might provide an ideal formula for use in a neoadjuvant setting. Prostate and colon cancer patients are often told to wait two months following biopsy before having surgery. He suggested conducting a study using these patients, in which the soup could be given to one group of patients and the placebo to another. Histologic changes in tissue between the biopsy and the surgery could be studied. The consensus of the committee was that Dr. Sun's work should be moved along to a Phase III clinical trial. The committee debated whether to suggest that Dr. Sun follow established channels used to test conventional treatments, or whether a different course should be charted. Complicating the debate is Dr. Sun's status as holder of a patent for the SV soup. Since he has a financial stake in the outcome of the Phase III trial, there was much debate about the extent to which he should be involved. Many committee members said they believed his involvement was crucial. The committee agreed that the program staff will examine several mechanisms for moving the research forward and prepare a report for the committee to consider at its December 1999 meeting.

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XII. Concept Review of Best Case Series Presentation: Homeopathic Treatment of Cancer

Dr. Hawkins explained that the closed session on July 8 had been a best case series presentation by Drs. Prasanta and Pratip Banerji. It was a retrospective examination of 12 cases involving patients with various malignancies, including seven patients with lung cancer, first seen at Prasanta Dr. Banerji's very busy clinic in India between 1990 and 1998. Dr. Banerji presented data showing four documented cases of tumor regression and told the panel that he did not think that these tumor regressions were unusual for his clinic. The committee was generally enthusiastic about the best case series presentation. After reviewing the data at the July 8 session, panel members believed the tumor regressions in the four patients were "very striking and unusual," as stated by Dr. Katz. Members indicated a strong willingness to lend support to further study of Dr. Banerji's methods. Questions and concerns focused on the following areas:

Can the results be replicated? Can these outcomes be translated to Western culture?

How can a workable protocol be developed to study the use of homeopathic agents?

How can the Banerji team be enlisted as active collaborators without negatively affecting the patients at their clinic? Dr. Peter Choyke observed problems in four areas that must be resolved if further study is to take place: (1) the quality of pathology seemed variable; (2) some variability existed in the quality of imaging; (3) patient follow-up seemed inconsistent because of travel problems, and support-including financial help-would be needed to rectify this situation; and (4) a formal computerized data management system should be put in place. Several committee members agreed that significant financial support would be needed because of the extreme poverty in the area where the clinic operates. Dr. Hawkins addressed the need for a humanitarian approach with an overlay of scientific support. The committee strongly recommended sending a representative to India to observe Dr. Banerji's clinic and determine the feasibility of further study, with assurances of no negative consequences for the work Dr. Banerji and his staff are doing in their very busy practice.

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XIII. Review of the CAPCAM Process

Dr. Harlan read Dr. Wynder's faxed/written comments. Again, Dr. Wynder stressed the need to formulate guidelines so that CAM can be regarded as cost-effective. He set a four-month deadline for completing subcommittee assignments. Dr. Harlan told the committee that by the next meeting in December, the committee should receive follow-up on questions from this meeting, including "perhaps" a report on a visit to the Banerji clinic in India as well as a report on further conversations with Dr. Sun. He asked the committee members to provide feedback on the information they received so far and for information on how to improve the CAPCAM process.

Dr. Hawkins said the committee needs to have much of the information in advance of the scheduled meetings. For best case series, he said, it would be better for the review to take place outside of the committee so that the committee can focus on discussion. To that end, he said, he would like to see a summary of research from Dr. White in advance of each meeting and a carefully prepared, concise half-hour presentation from the researcher at the meeting. Dr. Hufford asked that each presenter distribute a one- or two-page backgrounder that addresses the research approach taken so that the committee can have a clearer picture of the consequences of its recommendation. Dr. Gordon stressed the need to send a clear message to the conventional medicine and CAM communities about the openness of the CAPCAM committee, and Dr. White asked for specific help from all CAPCAM members on how to go about this. Dr. Katz told the group she believed that the committee had developed part of a road map, but said a decision tree should be drafted by the next meeting to simplify the process of taking a next step.

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XIV. Public Comment - Ann E. Fonfa, The Annie Appleseed Project

The remarks of Ms. Fonfa, who has been living with breast cancer since 1993, were read by her representative. Ms. Fonfa stressed the need for research in areas other than conventional medicine and specifically asked the committee to consider factors such as whole products and combination ingredients, not just active ingredients or single agents. She recommended exercising caution, however, in conducting studies using combination agents on small test groups. The success of a treatment should be measured against an existing or other experimental agent, she said, and she suggested adding an alternative medicine arm to all conventional trials conducted by FDA. Finally, she urged the Federal government to spend more money on the study of alternative medicine in cancer and to provide wider and more timely publicity to public meetings like the CAPCAM meeting.

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XV. Adjournment

The meeting was adjourned at 1:15 p.m.

Certification: We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Richard L. Nahin, M.P.H., Ph.D. Michael Hawkins, M.D.
Executive Secretary and Deputy Director, Chair,
National Center for Complementary and Alternative Medicine, National Institutes of Health Cancer Advisory Panel for Complementary and Alternative Medicine National Institues of Health

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