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Forward

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 evokedby 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 willdie 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 treatmentsthat exist outside, at varying distances from, the bounds of mainstream medical research —from supportive psychological approaches used as adjuncts to and practice. The range is broad standard treatments, to a variety of practices thatreject the norms of mainstream medical practice. To many patients, the attractiveness of such unconventional cancer treatments may stem in part from the acknowledged inadequacies ofcurrent 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. Recognizingthis, 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 ofunconventional 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, andthe 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 Immuno-AugmentativeTherapy-and to design a clinical a particular unconventional treatment—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, particularlyto 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 throughdifficult discussions and provided valuable counsel. Much of the final meeting of the advisory panel was organizedto 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 devoteda 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 thepublic 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’salone 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 waysdescribed 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.

JOHN H. GIBBONS Director

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