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- stream. Objective, informed examination of unconven- 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– 4 ● Unconventional Cancer Treatments tion base in support of the claims; suggests possible took, as part of this project, a case study to develop ways of generating valid information about their a protocol for a clinical trial to study the efficacy and safety and effectiveness; and presents the legal safety of IAT. The results of this effort are reported issues surrounding unconventional treatments that in chapter 6. have brought civil and criminal litigation to bear on the subject. THE TERMINOLOGY OF We focus on unconventional cancer treatments, UNCONVENTIONAL CANCER and not on the successes and failures of mainstream TREATMENTS medicine, either in general or in treating cancer. To help describe the context in which unconventional “Unconventional” is just one of many terms, all treatments exist, however, a brief summary of the imperfect descriptors, that were considered, for the status of mainstream cancer treatment is included purposes of this report, to refer to the wide variety of later in this chapter. But this report is neither a treatments that fall outside the bounds of main- comparison of mainstream and unconventional treat- stream medicine. Other terms used by proponents to ments nor an equal critique of both. In many places, describe all or some of these treatments include: the discussions of unconventional treatments in the alternative, complementary, nontoxic, holistic, natu- report are quite critical, e.g., of the quality of ral, and noninvasive. Those used by the sharpest of evidence offered to support the treatments, of the critics include: unproven, questionable, dubious, claims that are made, etc. quackery, and fraudulent. At the beginning of this study, the term ‘‘nontraditional’ was used to In addition, adverse effects are pointed out when describe the treatments, but was unacceptable since there is information about them. These points are not ‘‘traditional’ is widely used to refer to various types intended to suggest that mainstream medicine is free of native healers and treatments, as in traditional of faults, that its promise is always realized, or that Chinese medicine; nontraditional, therefore, could practitioners of mainstream medicine are aware of describe mainstream medicine. During much of the and use the best possible treatments for their project, the adjective “unorthodox” was used, patients. OTA and many other organizations and chosen as a term as free as possible from value authors have produced critical analyses of various judgments about the quality of the treatments being areas of mainstream research and medical practice, discussed. Eventually, protests from both sides of and these are available for the reader. The aim of this the debate prompted the change to the term ‘uncon- report, rather, is to produce an assessment of ventional.” We intend no implicit message in the unconventional treatments, as far as is possible use of the word ‘‘unconventional;” it was chosen today. with the hope that debate engendered by this report could center not on that word, but on the issues REQUEST FOR THE STUDY themselves. This report responds to a request by the U.S. HISTORICAL PERSPECTIVE House of Representatives Committee on Energy and Commerce (a committee with jurisdiction over a Physicians and the organizations they have cre- wide range of health issues), which asked OTA to ated have come to dominate health care and bi- omedical research in the United States during the examine the subject of unconventional cancer treat- ments. OTA also received letters signed by 42 20th century. “Scientific medicine” owes much of individual Members of Congress, asking for an its rise to major advances in public health: the assessment of a particular treatment, Immuno- success of vaccination in preventing infectious Augmentative Therapy (IAT). Their request was diseases;