Abstract
"Unproven" is a euphemism for questionable. The definition of a questionable method is that it has not successfully answered the two basic consumer protection questions of efficacy and safety, to wit: Has it been responsibly, objectively, reproducibly, and reliably demonstrated in humans in the responsible (peer-reviewed) literature accepted for the shelves of the National Library of Medicine in Bethesda, Maryland, to be: More effective than suggestion or doing nothing? and in addition, either As safe as doing nothing? or, in the alternative, If there is any question with respect to safety, to have a reasonably and objectively clear potential for benefit which exceeds its potential for harm? Any proposed cancer prevention or treatment modality which has not successfully answered the above efficacy question plus one of the two safety questions is by definition questionable. It is experimental if it is new, and very probably quackery if it is old. Experimental therapy may be either ethical and responsible or unethical and irresponsible. It is unethical and irresponsible to not tell the patient experiments are being conducted on him, to charge the patient to perform research on him, or to ask the patient to sign an informed consent aimed at exculpating the doctor rather than protecting the patient. Ethical and responsible informed consents clearly delineate that what is being done is experimental, and that efficacy and safety have not been determined. Products promoted for profit to the public without passing peer process are almost without exception ineffective, often harmful, and sometimes lethal. This includes Laetrile, immunoaugmentative therapy, chelation therapy, macrobiotic diets, and other alternative therapies. Anecdotal and testimonial claims of cure, on investigation, almost invariably prove due to coincidence, suggestibility, and/or the natural history of the disorder, and fall into one of the five categories of "cures that are not": The patient never had cancer. The cancer was cured or put in remission by responsible therapy, but the promoted therapy was irrelevantly also given, and is erroneously credited for the cure. The cancer is progressing silently, but erroneously represented as cured. The patient is dead, but represented as cured. The patient had a spontaneous remission, which is publicized as a "cure," while failing to publicize the hundred or more deaths per "success" which followed the same "cure." Quackery involves the consumer fraud of taking money under false pretenses. The false pretense is the promotion and selling of questionable diagnostic tests and therapies advertising them to be safe and effective.(ABSTRACT TRUNCATED AT 400 WORDS)

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