ebook img

Alternative Cancer Treatments PDF

594 Pages·1990·11.02 MB·English
Save to my drive
Quick download
Download
Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.

Preview Alternative Cancer Treatments

Unconventional Cancer Treatments September 1990 OTA-H-405 NTIS order #PB91-104893 Recommended Citation: U.S. Congress, Office of Technology Assessment, Unconventional Cancer Treatments, OTA-H-405 (Washington, DC: U.S. Government Printing Office, September 1990). For sale by the Superintendent of Documents U.S. Government Printing OffIce, Washington, DC 20402-9325 (order form can be found in the back of this report) Foreword A diagnosis of cancer can transform abruptly the lives of patients and those around them, as individuals attempt to cope with the changed circumstances of their lives and the strong emotions evoked by the disease. While mainstream medicine can improve the prospects for long-term survival for about half of the approximately one million Americans diagnosed with cancer each year, the rest will die of their disease within a few years. There remains a degree of uncertainty and desperation associated with “facing the odds” in cancer treatment. To thousands of patients, mainstream medicine’s role in cancer treatment is not sufficient. Instead, they seek to supplement or supplant conventional cancer treatments with a variety of treatments that exist outside, at varying distances from, the bounds of mainstream medical research and practice. The range is broad—from supportive psychological approaches used as adjuncts to standard treatments, to a variety of practices that reject the norms of mainstream medical practice. To many patients, the attractiveness of such unconventional cancer treatments may stem in part from the acknowledged inadequacies of current medically-accepted treatments, and from the too frequent inattention of mainstream medical research and practice to the wider dimensions of a cancer patient’s concerns. Unconventional cancer treatments have received only cursory examination in the research literature, making an objective assessment of their efficacy and safety exceedingly difficult.lt. Recognizing this, the Chairman of the U.S. House of Representatives Committee on Energy and Commerce, John Dingell, asked OTA to review the issues surrounding unconventional treatments: the types of unconventional cancer treatment most available to American citizens and how people access them, costs and means of payment, profiles of typical users of unconventional treatments, legal issues, and the potential for enhancing our knowledge about the efficacy and safety of these cancer treatments. A group of Members of Congress, led by then-Congressman Guy Molinari, also asked OTA to examine a particular unconventional treatment—Immuno-Augmentative Therapy-and to design a clinical trial protocol to permit valid evidence of efficacy and safety to be gathered. All these topics are covered in this report. The debate concerning unconventional treatments is passionate, often bitter and vituperative, and highly polarized. To ensure that all relevant voices were heard and that OTA was accessible, particularly to advocates of unconventional treatments, OTA took several unusual measures during the course of this assessment in addition to its normal process of analysis and review. The project advisory panel, representing a diversity of views, played an important role. Under its Chairperson, Professor Rosemary Stevens of the University of Pennsylvania, the panel persevered through diffilcult discussions and provided valuable counsel. Much of the final meeting of the advisory panel was organized to hear from critics of the draft report, who were invited by OTA to present their concerns to the advisory panel and OTA staff. OTA’s standing Technology Assessment Advisory Council devoted a meeting to this assessment, discussing the science and policy issues related to unconventional cancer treatments and providing counsel to OTA. Many other individuals and groups in the public and private sectors also contributed their ideas and criticism, for which they are gratefully acknowledged. As with all OTA assessments, however, responsibility for the content of the report is OTA’s alone and does not necessarily constitute the consensus of the advisory panel, the Technology Assessment Board, or the Technology Assessment Advisory Council. If history in this area is predictive, some few unconventional treatments may be adopted into mainstream practice in the years ahead, others will fade from the scene, and new ones will arise. The ways described in this report to stimulate the valid assessment of unconventional treatments could give the medical community and patients the means to make more informed decisions about their use. /J’/~ 6AM’ ‘ > JOHN H. GIBBONS . . . Director Ill Unconventional Cancer Treatments Advisory Panel Rosemary Stevens, Ph.D., Panel Chair University of Pennsylvania Philadelphia, Pennsylvania Jeanne Achterberg, Ph.D. Brian J. Lewis, M.D. Institute of Transpersonal Psychology Kaiser Permanence Medical Center Menlo Park, California San Francisco, California Keith Block, M.D. Robert W. McDivitt, M.D. University of Illinois School of Medicine Barnes Hospital Chicago, Illinois St. Louis, Missouri Barrie R. Cassileth, Ph.D. Grace Powers Monaco, J.D. Hospital of the University of Pennsylvania Emprise Inc. Philadelphia, Pennsylvania Washington, DC Jonathan Collin, M.D. Herbert F. Oettgen, M.D. Port Townsend, Washington Memorial Sloan-Kettering Cancer Center New York, New York John H. Edmonson, M.D. Mayo Clinic Brendan O’Regan Rochester, Minnesota Institute of Noetic Sciences Sausalito, California Robert C. Eyerly, M.D. Geisinger Medical Center Richard K. Riegelman, M.D., Ph.D. Danville, Pennsylvania George Washington University School of Medicine John Fink Washington, DC International Association of Cancer Victors and Friends C. Norman Shealy, M.D., Ph.D. Santa Barbara, California Shealy Institute for Comprehensive Health Care Stephen L. George, Ph.D. Fair Grove, Missouri Duke University Medical Center Durham, North Carolina Andrew T. Weil, M.D. University of Arizona Health Sciences Gar Hildenbrand Center Gerson Institute Tuscon, Arizona Bonita, California Special Consultant Michael Lerner, Ph.D. Commonweal Bolinas, California NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel members. The panel does not however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents. iv OTA Staff—Unconventional Cancer Treatments Roger C. Herdman, Assistant Director, OTA Health and Life Sciences Division Clyde J. Behney, Health Program Manager Project Staff Hellen Gelband, Project Director Julia T. Ostrowsky, Principal Analyst Sarah Dry, Research Assistant* Brigitte M. Duffy, Research Analyst** Sarah Sa’adah, Research Assistant*** Gwen Solan, Analyst**** Administrative Staff Virginia Cwalina, Office Administrator Eileen Murphy, P.C. Specialist Carolyn Martin, Word Processor Specialist Contractors Michael S. Evers, J.D., Project Cure Vicki S. Freimuth, Ph.D., University of Maryland Janice Guthrie, The Health Resource Sharon Hammond, University of Maryland David J. Hufford, Ph.D., Pennsylvania State University Michael Lerner, Ph.D., Commonweal Daniel J. Morns, M.D., H. Lee Moffitt Cancer Center Anne Paxton, Washington, DC Terence M. Phillips, Ph.D., D.Sc., George Washington University Medical Center Ronald D. Schwartz, J.D., and Rebecca L. Burke, J.D., White, Fine & Verville Patricia Spain Ward, Ph.D., University of Illinois at Chicago Robert Watson, University of North Texas Jack Z. Yetiv, M.D., Ph.D., San Carlos, CA *From ~e~m 1987 util APfi 1989. **~om July 1989 to June 1990. ***From J~e 1990. ****From Wch 1987 to February 1989. Working Group on Immuno-Augmentative Therapy ROSS Burrus, Ph.D. Curry Hutchinson (deceased) Science Applications International Corporation Immunology Researching Centre/IAT Ltd. Lenoir City, Tennessee Freeport, Grand Bahamas Donald F. Gleason, M.D., Ph.D. Michael Lerner, M.D. University of Minnesota Medical School Commonweal Minneapolis, Minnesota Bolinas, California I. Craig Henderson, M.D. Robert W. Makuch, Ph.D. Dana Farber Cancer Institute Yale University Boston, Massachusetts Connecticut Cancer Research Unit New Haven, Connecticut Thomas Holohan, M.D. Food and Drug Administration Maryann Roper, M.D. Rockville, Maryland National Cancer Institute Bethesda, Maryland Consultants to the Working Group Costan W. Berard, M.D. Freddie Ann Hoffman, M.D. St. Judes Hospital and Child Research Center Food and Drug Administration Memphis, Tennessee Rockville, Maryland Clara D. Bloomfield, M.D. Richard Peto University of Minnesota Hospital and Clinic University of Oxford Minneapolis, Minnesota Oxford, England NOTE: OTA appreciates and is grateful for the valuable assistance provided by the working group members and consultants. The working group does no$ however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents. w“ Contents Chapter 1: Summary and Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Chapter 2: Behavioral and Psychological Approaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Chapter 3: Dietary Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Chapter 4: Herbal Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Chapter 5: Pharmacologic and Biologic Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Chapter6: Immuno-Augmentative Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Addendum: Memorandum of Understanding Between OTA and Lawrence Burton Concerning a Clinical Trial of-IAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Chapter 7: Patients Who Use Unconventional Cancer Treatments and How They Find Out About Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151 Chapter 8: Organized Efforts Related to Unconventional Cancer Treatments: Information, Advocacy, and Opposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Chapter 9: Financial Access to Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . 175 Chapter 10: Laws and Regulations Affecting Unconventional Cancer Treatments . . . . . . . . . . 197 Chapter 11: Laws and Regulations Governing Practitioners Who Offer Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213 Chapter 12: Evaluating Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225 Appendix A: Method of the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239 Appendix B: Glossary of Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244 Appendix C: Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .250 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.57 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291 Boxes Box Page 3-A. An Example of an Adjunctive Nutritional Approach to Cancer Treatment . . . . . . . . . . . . 43 3-B. Coffee Enemas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1 8-A. The American Medical Association: Historical View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 1O-A. How the Safety and Efficacy of New Drugs Are Established . . . . . . . . . . . . . . . . . . . . ... 202 Tables Table Page 8-1. Unconventional Cancer Treatments and Practitioners for Which NCI/CIS Has Standard Response Paragraphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160 8-2. Treatments and Proponents of Treatments Declared Unproven in ACS Statements on Unproven Methods of Cancer Management, 1987 . . . . . . . . . . . . . . . . . . . . . 164 9-1. Total Initial Treatment Charges for Proprietary Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . 181 9-2. Costs of Selected Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182 vii Chapter 1 Summary and Options CONTENTS Page Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Request for the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The Terminology of Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Historical Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Legal Issues .-~. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 International Perspective on the Availability of Unconventional Cancer Treatments in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Current Mainstream Treatments for Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Controversies in Mainstream Cancer Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Treatments Discussed in this Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Categories of Unconventional Cancer Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Practitioners of Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 The Information Network for Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . 17 Patients Who Use Unconventional Cancer Treatments . . . * . . . . . * * .,, , . * *, *, . ..*.*,.,. 18 Costs and Insurance Coverage of Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . 18 Evaluating Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Options To Broaden the Base of Information on the Use of Unconventional Cancer Treatments in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Gathering and Making Available Information on Unconventional Cancer Treatments and Practitioners . ......................,**..,+....,..***.,..****.* 25 Improving Information on the Efficacy and Safety of Treatments Used by U.S. Citizens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Making Available Information on Legal Sanctions Against Practitioners and Health Fraud Related to Unconventional Cancer Treatments . . . . . . . . . . . . . . . . . . . . 26 Chapter 1 Summary and Options INTRODUCTION “Unconventional treatments”—the phrase cho- sen for this report to describe treatments outside of Each year, thousands of U.S. cancer patients use mainstream medical practice and research-are not treatments that fall outside the generally understood limited to treatments for cancer. They are of bounds of mainstream medicine. While the majority considerable public interest in the United States, but of cancer patients do not use such treatments, those their use has received little formal study. The range who do represent a visible minority (though the of treatments offered, the people who offer them, the exact numbers are unknown). Additional thousands number and types of patients who use them, and their may be interested in such unconventional treatments costs are largely undocumented. The reliability of and seek information about them. information on the effectiveness and safety of these treatments is questioned by most mainstream medi- Although any examination of unconventional cal authorities, in part because most reports are cancer treatments will fall short of capturing all the anecdotal or represent unsupported claims of practi- reasons for cancer patients’ interest in them, certain tioners. Research and clinical studies of unconven- factors seem clear. Effective treatments are lacking tional cancer treatments generally have not been for many cancers, especially in advanced stages; well designed and have not met with the approval of many mainstream treatments entail considerable academic researchers. Supporters of unconventional toxicity; and long-term survival may be uncertain treatments tacitly approve these reports in the even after apparently successful treatment. These absence of anything better. Thus, one of the major realities of mainstream treatment, coupled with rifts separating supporters of unconventional treat- explicit or implicit promises of effective, nontoxic ments from those in mainstream medical care and cancer control by unconventional means, and the research is a distinct difference in what they accept strong support of cancer patients for them, motivate as evidence of benefit. new patients to seek treatments outside the main- Objective, informed examination of unconven- stream. tional treatments is thus difficult, if not impossible, in the United States today. Acrimonious debate Unconventional treatments vary greatly in con- between the unconventional and mainstream com- tent, and range from some that may be used easily munities reaches well beyond scientifc argument along with mainstream treatment to those that, either into social, legal, and consumer issues. Sides are because of the nature of the treatment, or because of closely drawn and the rhetoric is often bitter and the stance of the practitioner offering them, are used confrontational. Little or no constructive dialog has exclusive of mainstream medicine. They also range yet taken place. In the course of this study, OTA from those that are entirely within legal rules and involved individuals with a wide spectrum of views ethical assumptions to practices that rely on drugs about unconventional and mainstream treatments, and biologics that are not approved and are not and went to great lengths to open the process to within the bounds of U.S. law. allow all viewpoints to be aired. This spectrum was represented on the advisory panel as well as among Additionally, regardless of the nature of the the hundreds of outside providers of information and approach taken, patients seek not only a hopeful reviewers who took part in the study. It is fair to say, prognosis, but also treatment perceived as humane however, that, while OTA heard and reported the and caring and psychological support from care- viewpoints, the process did not bridge the gulf givers and fellow patients. These are elements that between two highly polarized positions. at least some patients believe are missing from mainstream medicine. Another important aspect is This report describes the unconventional cancer the sense of personal control that may be gained treatments that are most used by U.S. cancer from deciding on a course of treatment and pursuing patients; it describes the way in which people find it, sometimes in defiance of physicians, family, and out about them and how much they pay for them; friends. reviews the claims made for them and the informa- -3–

See more

The list of books you might like

Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.