Cosmetic Act (FDCA), FDA oversees distribution of the Nation's food supply, oversees development and marketing of new drugs and medical devices, and generally supervises the promotion of these items to ensure that consumers are not harmed or defrauded. Under the FDCA, new drugs require extensive laboratory and animal testing before their sponsors can petition FDA for an investigational new drug (IND) application for limited testing in humans. IND applications must state in detail how the clinical trials will be conducted (e.g., how subjects will be selected and how many will be involved with the studies), where the studies will be done and by whom, and how the product's safety and effectiveness will be evaluated. Clinical trials are generally done in three phases. Phase I studies are designed to determine the safety of the product using small numbers of healthy subjects. Phase II studies are concerned more with the effectiveness of the product, usually employ up to several hundred volunteers diagnosed with the particular disease or condition under investigation, and may take 2 years or more to complete. Phase III studies, which may require several hundred to several thousand subjects and take 4 years or more to complete, are then designed to elaborate the correct dosage and frequency of administration of the product (Evers, 1988). The entire drug approval process is timeconsuming and extremely expensive, forcing treatment sponsors to spend millions of dollars each year to comply with FDA's safety and efficacy regulations. For example, a manufacturer must submit more than 100,000 pages of supporting documentation in connection with a single new drug application (Hect, 1983). It can take up to 10 years and cost hundreds of millions of dollars to obtain FDA approval of a new drug (Evers, 1988; also see the "Herbal Medicine" chapter). These astronomical costs are beyond the reach of all but a few corporations and can be recouped only by exercising the legal 17-year monopolies conferred by the U.S. patent laws. With a patent, drug companies can and do charge whatever the market will bear. Thus, the current Federal mechanisms of regulating medical research do not favor the evaluation of many forms of alternative treatment. Because the costs of developing, evaluating, and marketing new drugs are so prohibitive, pharmaceutical companies are not likely to invest time and effort in therapies, such as nutritional or behavioral approaches, that cannot be patented and are therefore unlikely to offer the opportunity to recover their investment and provide a return to stockholders. This means that many alternative therapies are likely to be casualties of the formal research process. Although foods are exempt from such extensive premarketing clearance, the FDA often regulates foods as if they were drugs whenever any health claims are associated with a product, even though the same product may also qualify as a food or as a cosmetic. A recent controversy surrounding the advertising campaign of a popular breakfast cereal demonstrates how overzealous FDA can be at times. FDA disapproved of the manufacturer's claims that its cereal would help prevent colon cancer, even though the company had prepared the advertisement in cooperation with the National Cancer Institute. FDA launched a probe into the matter, which it later had to abandon (Evers, 1988). FDA has long attempted to regulate vitamins and minerals as drugs. The AMA supports this view and has urged Congress to grant FDA such authority (U.S. Congress, 1984). To date, Congress has not chosen to extend FDA's drug jurisdiction to encompass vitamins and minerals, except in cases where therapeutic claims are made for products. Although the FDCA is the most comprehensive law designed to prevent interstate marketing of unapproved drugs, several other Federal statutes also are applicable to promotion or sale. The Federal Trade Commission (FTC) often uses the term false advertisement under the Federal Trade Commission Act to prevent the manufacturers of alternative therapies from promoting their products or services. Courts have generally held that the FTC does not have to show that an advertiser lacked good faith or intended to deceive, nor must it show that actual deception occurred. Rather, it has to show only that the potential to deceive might be there. The FTC frequently seeks to hinder what it considers false advertising dealing with disease prevention or cure. For example, in 1983 the FTC sought to prohibit the manufacturer of a dietary supplement-which contained vitamins A, Ć, and E; selenium; beta-carotene; and dehydrated vegetables-from advertising its product as reducing the risk of certain cancers. The manufacturer's claims were based on the findings of a report entitled Diet, Nutrition, and Cancer, published by the National Research Council (1982). The FTC successfully argued that the manufacturer's representations went well beyond the report's conclusions and thus were false, misleading, and deceptive because they conveyed the impression that simply consuming daily portions of the product would prevent cancer. Accordingly, an injunction was issued prohibiting such advertisements (Evers, 1988). In addition to FDA and FTC restrictions and regulations, the Federal Government routinely uses numerous other statutes to curtail the promotion of alternative treatments and practices. Statutes such as the mail fraud and wire fraud statutes and the "smuggling statute" are among the many laws that provide criminal penalties for those who promote unapproved products through the mail or on the radio or attempt to import them from overseas. Penalties can be fines of up to $10,000 or 5 years' imprisonment or both. Another major barrier to the investigation and acceptance of alternative medicine is the existence in all States of medical practice acts that limit the practice of healing arts to holders of medical licenses. The history of medical licensure illustrates not only the enormous power bestowed on professional groups by regulation, but also the ways licensing has been used to eliminate or curtail the activities of alternative medical practitioners, regardless of whether their methods have been proved harmful. For example, throughout this century the medical professional organizations have used a variety of weapons to harass osteopathic and chiropractic physicians. Indeed, conventional medical organizations have historically prohibited their members from even consulting with "sectarian" practitioners such as homeopaths and chiropractors (see below). Medical organizations establish such prohibitions for reasons that have to do as much with ideology as with economics. The ideological reasons are discussed below. Belief Barriers Conventional physicians in general adhere to a number of beliefs and misconceptions about themselves and the type of medicine they prac tice that prevent them from viewing anything labeled "alternative" in a positive light or taking it seriously. The following are some of the ideological grounds for conventional physicians' skepticism of alternative systems of medicine and their therapies. Confidence in high technology. High-tech diagnostic and therapeutic procedures in modern medicine are often enormously attractive to the physician. However, confidence in these instruments and procedures often exceeds the evidence for their effectiveness (Grimes, 1993). As a result, many alternative therapies, which are often relatively "low tech," may be considered ineffective. Safety in the status quo. Once in place, established therapies often tend to prevail over new or alternative treatments. How much and what kind of evidence is necessary for implementing an alternative therapy? This question has not been fully answered even for conventional therapies. For example, acceptance of a new drug therapy usually requires repeated, double-blind, placebo-controlled, randomized clinical trials, whereas implementation of new surgical techniques may at times be done without any controlled trials at all (Eddy, 1990). • The "one true" medical profession. A longstanding belief held by many conventional medical practitioners is that there should be only one representative voice for the whole of medicine (Gevitz, 1989). That is, only the members of their profession, holders of a certain degree from approved institutions, are the bona fide, rightful, and exclusive representatives of medicine, and they should be allowed to control all aspects of medical practice (Inglis, 1965). For example, in the 1960s the AMA decided to contain and eliminate chiropractic as a profession. To do so, in 1963 the AMA formed its Committee on Quackery, which worked aggressively—both overtly and covertly to find ways to cut off chiropractors from their base of patients. One of the AMA's principal means of achieving this goal was to make it unethical for a medical physician to associate with an "unscientific practitioner." Then, in 1966, the AMA's House of Delegates passed a resolution calling chiropractic an "unscientific cult." To complete the circle, the AMA's Judicial Council issued an opinion holding that it was unethical for a physician to associate professionally with chiropractors (Gevitz, 1989). Although the AMA gradually relaxed some of its taboos regarding chiropractors, these relaxed positions were generally not communicated to AMA members (Gevitz, 1989). However, in the August 1987 Wilk et al. v. the American Medical Association decision, a Federal judge found that the AMA, the American College of Radiology, and the American College of Surgeons had conspired to intentionally harm the chiropractic profession and were thus guilty of violating the Sherman Antitrust Act (Special Communication, 1988). Under the court's ruling, the AMA was ordered to cease and desist its hampering of chiropractors and to send a copy of the injunction to each of its members. • Stereotypes. One stereotype of alternative medicine that is widely propagated is that it attracts people with "weak" minds (i.e., the uneducated and the poor) who easily succumb to the "sideshow" lures of "snake oil" salespeople, who are not qualified to give medical advice or to practice medicine. However, recent studies of cancer patients indicate that, much to the contrary, well-educated persons with higher incomes are more likely to use alternative treatments, primarily because they want to take charge of their health (Lerner and Kennedy, 1992; McGinnis, 1991). Furthermore, more than 60 percent of practitioners of alternative treatments for cancer hold an M.D., a Ph.D., or both from an accredited medical school or graduate school (Cassileth et al., 1984). In addition, the term quack, as a blanket indictment of all those who practice alternative forms of medicine, is often used more as an insult than as an objective assessment of someone's skills and intentions. According to Dr. David J. Hufford, professor of behavioral science at the Pennsylvania State College of Medicine, the term quack generally means "one who pretends to have medical knowl edge but does not; that is, it implies the element of fraud." Hufford contends that most alternative healers do not pretend to have medical knowledge but possess some other sort of knowledge that they and their clients believe is relevant to health. "Certainly the use of caution to protect oneself and one's family from unscrupulous and incompetent health care pretenders should be part of everyone's concern. But this is not limited to alternative medicine," he maintains (Hufford, 1990). The barriers facing many aspects of alternative medicine today are typical of the barriers that have faced novel scientific ideas throughout the centuries. At the root of this conflict is the fact that alternative and mainstream medical scientists often have two diametrically opposed views, not just on which drugs and vaccines are appropriate or most effective for a particular condition, but on the nature of life itself. The 20th-century scientific philosopher Thomas Kuhn put this age-old conflict into perspective by stating that scientific doctrines rest not just on facts, but more fundamentally on paradigms (i.e., broad views of how those facts should be organized).3 Differences in views among groups of people are a reflection of the different scientific paradigms they adhere to. According to Kuhn, because unusual scientific discoveries often require more than incremental adjustments to the dominant scientific paradigm, the hapless innovator who stumbles upon some new set of facts that run counter to the dominant paradigm often finds it necessary to elaborate a whole new paradigm to accommodate them. When this happens, the innovator often becomes a scientific outcast, for, as Kuhn wrote, "to desert the paradigm is to cease practicing the science it defines" (Kuhn, 1970). For example, Louis Pasteur, the father of microbiology, was thrown out of the Academy of Medicine for suggesting that microbes that could not be seen by the naked eye were responsible for causing food to spoil and that spontaneous generation (life arising from nonliving matter) was an impossibility (Kostychev, 1978). 3A paradigm is an overarching cosmological conceptual scheme; an explanatory model explains a limited set of events or observations from within a paradigm and using the guidance of a paradigm. Alternative words for paradigm include worldview, framework, and weltanschauung, all of which suggest the largeness of the concept. A paradigm tells whole societies in whole historical periods how to think about such “big issues" as goodness, success, holiness, love, and evil. Much of a paradigm is out of awareness-that is, people act on it without realizing that they have other choices. In contrast, an explanatory model is the way one discipline, denomination, or health care system explains itself—the details of its assumptions, logic, and rationale—and much of this is within the awareness of its practitioners, and is therefore open to argument, criticism, and change. Introduction by Larry Dossey, M.D. and James P. Swyers, M.A. The Constitution of this Republic should make special provision for Medical Freedom as well as Religious Freedom.... To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are unAmerican and despotic. They are fragments of monarchy and have no place in a Republic. History of Medicine in the United States M -Benjamin Rush Surgeon General of the Continental Army of the United States edicine in the United States has evolved from an eclectic mix of Native Ameri-can, African, Eastern, and European botanical traditions. In colonial and postcolonial America, there were dozens of competing medical philosophies, each claiming to have the "divine right" to practice medicine. By the early 1800s, medical practitioners included homeopaths, naturopaths, botanics, and Thomsonians. Competition was fierce, and the practice of medicine was essentially wide open (Hogan, 1979). However, in the mid-1800s, the medical system we now refer to as biomedicine1 began to dominate the scene. Biomedicine was shaped by two important sets of observations made in the early 1800s: (1) specific organic entities-bacteria-were responsible for producing particular disease states and characteristic pathological damage; and (2) certain substances-antitoxins and vaccines could improve an individual's ability to ward off the effects of these and other pathogens. Armed with this knowledge, investigators and clinicians began to conquer a myriad of devastating infectious diseases and to perfect surgical procedures. As their conquests mounted, biomedical scientists came to believe that once they found the offending pathogen, metabolic error, or chemical imbalance, all afflictions-including many mental illnesses-would eventually yield to the appropriate vaccine, antibiotic, or chemical compound (Gordon, 1980). This philosophy eventually led them to extend their purview beyond the bounds of physical and even mental disease to conditions that previously had been viewed in religious, moral, economic, or political terms. For example, births and deaths, which traditionally had taken place at home, were moved to the hospital. During the late 1800s, the American Medical Association (AMA), which was first organized ir 1847, sponsored and lobbied for enactment o State licensing laws. By 1900, every Stat hy enacted such a law. The result was decline in competition from other chan 'This is the more accurate technical term for the style of medical practice in which practitioners, mont ulkom |