brain, but they do not equate the two (Sperry, 1987, 1991).

• Maintaining the Hippocratic injunction: first do no harm. In general, many alternative practitioners use the least harmful therapies first. In addition, most alternative therapies tend to avoid suppressing symptoms because the symptoms are understood to be a manifestation of a more profound underlying imbalance-in physiology, attitude, and lifestyle that must be addressed. Therefore, most alternative medical practitioners tend to rely primarily on diet, exercise, relaxation techniques, and lifestyle and changes in attitude to bring about changes in health.

• Use of whole substances. Alternative practitioners understand that pharmacological agents, which may be extracted or synthesized from plants, may be more potent and fast acting. However, whole foods and herbs are believed to produce fewer adverse side effects.

In addition, the following concepts often are used by alternative systems of medicine and their practitioners and are important in understanding the rationale for such treatments:

• Holism. Holism is the principle that all aspects of the person-physical, emotional, mental, and psychosocial health; diet; lifestyle; and so on are interrelated and must be considered in treatment, not just the specific disease or specific body part that is affected. The holistic practitioner looks equally at the relationship among these aspects of the total person and at the presenting disorder. Closely associated with the principle of holism is the principle of balance.

• Balance and imbalance. Balance refers to harmony among organs in the body and among body systems, in a person's diet, and in relationships to other individuals, society, and the environment. Balance or imbalance in any of these systems is understood to holistically af

fect other systems as well. Thus people who are out of balance with society find their organs affected because of the societal imbalance. The quality of imbalance is expressed in similar but slightly different ways in different alternative medical systems-too hot or too cold, too yin (weak, quiet) or too yang (strong, loud), too high or too low, too wet or too dry, too sweet or too salty. To achieve balance, energy must be equalized between the imbalanced portions. People who use this term often do not use the concept of "disease"2 or use it in a much modified form.

• Energy refers to the force necessary to achieve balance; the part of the system that is deficient needs to acquire energy while the part that has excess needs to release energy. Thus (in traditional Chinese medicine, for example) when an organ is imbalanced, it is either too yang or too yin. Therefore, qi (the Chinese term for energy) must be transferred from the yang organ to the yin organ to restore balance and reestablish harmony among the organs; the harmony achieved extends holistically into all aspects (mental, physical, and psychosocial) of the person with beneficial effect. In practice, the holistic practitioner is likely to boost the vis medicatrix naturae by, for example, stimulating the immune system, balancing organ function by moving energy from the excessive organ to the deficient organ, altering diet to include more (or less) hot (or cold) foods, and prescribing more (or less) specific exercise or other lifestyle changes.

Healing and curing. Because of the focus on the total person, many alternative practitioners often measure their treatment success, or lack of it, on healing the total person-bringing all aspects of the person into better balance, rather than just focusing on curing a given disease or disorder. In this view, where total outcome is more important than specific result, it is possible for the person to be healed

without the disease being cured, although the intent is always to do both.

Interface Between Alternative and Conventional Medicine

In some areas, the distinction between what is alternative and what is conventional is not always so clear-cut, because there is a constant progression of therapies from the "fringe" into the mainstream. For example, manipulative therapies such as chiropractic were considered fringe therapies 20 years ago but now are gaining increasing acceptance in mainstream medicine in the United States (Cherkin et al., 1989). In a recent survey of conventional physicians in Britain, 75 percent said that some alternative practices had become conventional between 1982 and 1987. Fifty-four percent said that musculoskeletal manipulation had become conventional, 47 percent reported the same for hypnosis, and 45 percent said that acupuncture had become conventional for certain problems (Reilly and Taylor, 1991).

This increasing acceptance of some forms of alternative medicine is demonstrated by the fact that in the past few decades, a small but growing number of M.D.s in America have organized and taken courses in manipulative medicine to better serve their patients (Gevitz, 1993). In addition, an estimated 3,000 conventionally trained physicians-M.D.s and D.O.s (doctors of osteopathy)-have been trained to incorporate acupuncture as a treatment modality in their medical practices through courses such as those affiliated with the University of California, Los Angeles, School of Medicine; the New York University School of Medicine and Dentistry; and St. Louis University Medical School (Lytle, 1993).

Furthermore, a number of tenets of naturopathy, especially those linking particular foods to the incidence of certain diseases such as cancer, are beginning to gain more credence in mainstream science. Many recent case control and cohort studies indicate associations between high intake of red meat and increased risk of some forms of cancer (Willett, 1990); other studies have focused on the anticancer protective effects of a vegetarian diet (Rao and Janezic, 1992). Such associations have led to increased interest among researchers worldwide in investigating the role that micronutrients and other substances in fruits and vegetables may play in preventing or inhibiting serious disease (Lee,

1993). (See the "Diet and Nutrition" chapter for more information on the latest research regarding these issues.)

Given that what is considered alternative today may be the accepted treatment for a particular condition in a decade or two, the following question arises: Could any of today's fringe therapies have a significant, immediate impact on the pressing and costly medical problems facing the Nation if they were more widely available?

Barriers to Progress on Alternative Medicine Research

Barriers to a fair, unbiased, scientific evaluation of alternative therapies can be categorized as structural barriers (problems caused by classification, definition, cultural, or language barriers), regulatory and economic barriers (the legal and cost implications of compliance or noncompliance with Federal and State regulations), and belief barriers (obstacles caused by ideology, misconceptions, myths, etc.).

Structural Barriers

As mentioned previously, a basic problem in investigating alternative therapies is that a clear definition of alternative medicine is almost impossible to devise. Alternative therapies are often referred to by a diverse group of sometimes derogatory. pseudonyms, including "unconventional," "unorthodox," "integrated," "nonmainstream,” "traditional," "nontraditional," "natural,” “unscientific," "holistic," "wholistic," and many others, making classification difficult (Jonas, 1993). Other questions arise: Is the use of megavitamins, food supplements, or nutritional regimens to treat disease considered medicine, or is it a lifestyle change, or both? Can having one's aching back massaged be considered a medical therapy? How should spiritual healing and prayer-some of the oldest, most widely applied, and least studied unconventional approaches— be classified?

Because the line between conventional and alternative is imprecise and frequently changing, an approach to evaluation must be devised that is useful for comparing all types of therapy. The unfamiliar diagnostic outcome categories in many alternative approaches may require two sets of classification criteria (Wiegart et al., 1991). Traditional acupuncture, for example, classifies patients

according to excesses or deficiencies in vital energy, or chi, in contrast to Western diagnostic classifications that are based on pathological or symptom complexes (coronary artery disease, depression, etc.). Scientists rarely understand and may oversimplify these alternative medicine concepts and thus may design methodologically correct research on the basis of incorrect classifications, resulting in unusable data (Bensoussan, 1991; Patel, 1991).

In addition, reprints of original research in alternative medicine are difficult to locate. Many alternative medicine research studies, especially those conducted in other countries, are not published in scientifically reviewed literature, and much of what does exist is not in English. For example, more than 600 research articles or abstracts have been published on the medical effects of qigong (a Chinese term for a form of energy), but few have been translated from Chinese (Sancier et al., 1993). The retrieval of information on alternative medicine from online databases is often inadequate, because these databases do not routinely collect articles from alternative medicine journals (Bareta et al., 1990; Dickerson, 1990; Easterbrook et al., 1991) or because the ones they do collect are not accessible by standard search languages (see the "Research Databases" chapter).

Many alternative medicine practitioners are primarily clinicians rather than researchers, and medical practice is their primary priority. Therefore, case series and anecdotal reports are often their only evidence that a practice is effective. Even so, the quality of the research presented by alternative medical practitioners is not always poor, and the fact that an article is published in an alternative medical journal does not mean the study is inferior. For example, a meta-analysis of 107 published controlled trials of homeopathic treatments to assess their methodological quality found that while many of the trials were of "low" methodological quality, there appeared to be an overall positive effect from the homeopathic treatment regardless of the quality of the trial. The authors of the study noted that while no definitive conclusions about the effectiveness of homeopathic treatments could be drawn, the meta-analysis supported a legitimate case for the further evaluation of homeopathy (Kleijnen et al., 1991).

Therefore, one cannot assume that practices unfamiliar to conventional physicians and researchers are necessarily backed by poor-quality research. Surprisingly, adequate methods for judging the quality of research in individual alternative medicine studies, both published and unpublished, still remain an underdeveloped research area. Scientists who conduct reviews of the literature on alternative medicine must be comprehensive, systematic, and explicit (Fuchs and Garber, 1990; Larson et al., 1986; Sachett et al., 1991).

Finally, many conventional physicians remain virtually unaware that alternative approaches exist, even though their patients are seeing them and alternative medical practitioners simultaneously for the same condition. The EisenbergKessler survey (Eisenberg et al., 1993) found that 70 percent of patients seeking alternative practices did not reveal to their conventional physicians that they had done so. Patients' unwillingness to reveal this information to their conventional physicians may be largely due to the physician-centered model discussed above. Recently, an increasing number of members of the conventional medical community have called for physicians to move toward a patient-centered model for educating and interacting with patients. The impetus for this is a realization that the majority of patients want to participate in their clinical decisionmaking and are more likely to adhere to a prescribed therapy using this approach (Brody and Larson, 1992; Brunton, 1984; Titus et al., 1980).

Regulatory and Economic Barriers

Today there are literally hundreds of treatments that are considered alternative, or outside the range of conventional medical treatment modalities. These treatments include various forms of behavioral, psychological, and spiritual interventions, as well as a host of herbal, pharmacological, nutritional, and mechanical therapies. Promoters of these therapies include trained physicians and other allied health care practitioners as well as laypersons.

The U.S. Food and Drug Administration (FDA) is the Federal agency most responsible for protecting consumers against unsafe and ineffective medicines and health products in the marketplace. Armed with broad regulatory powers delegated to the agency by the Food, Drug, and

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, C,

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