Alternative Cancer Treatments

594 Pages·1990·11.02 MB·English

by  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’
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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-
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