Complementary and Alternative Medicine in Society: An Introduction

David Mischoulon

Jerrold F. Rosenbaum

This chapter was previously published by the author in modified form in the following: Mischoulon D. Nutraceuticals in psychiatry, Part 1: social, technical, economic, and political perspectives. Contemp Psychiatry 2004;2:1-6 (used with permission).

Complementary and alternative medicine (CAM), which has been used for centuries in many parts of the world, has become a major staple of the American lifestyle in the new millennium. Over the past decade or so, the CAM machine has evolved from an “underground” industry to a multibillion-dollar empire (1) and a major component of health care and general wellness in the United States and worldwide. Studies suggest that >70% of the world’s population uses some sort of complementary medicine, and in the United States more visits are made to “alternative” practitioners instead of primary care physicians (2, 3, 4). Nutrition Business Journal recently reported that sales of dietary supplements in 2006 were in excess of $20 billion in the United States and $66 billion globally (5). The local health food store has become the cornerstone of many neighborhoods, as growing numbers of baby boomers self-medicate with over-the-counter natural products in the hopes of fending off the effects of aging and better managing their increasingly “time-starved” lives (1).

Several factors have contributed to the dramatic increase in the popularity of complementary medicine. Growing numbers of nonphysician practitioners, including chiropractors, acupuncturists, herbalists, and other healers, recommend these therapies (6). The increased availability of information about illness and possible treatments, especially through the media and the Internet, has encouraged medical consumers to seek answers to medical and psychiatric problems on their own. Nutraceutical manufacturers, much like pharmaceutical companies, regularly advertise their products directly to consumers, who in turn may ask their doctors to prescribe them or may obtain them independently. The growing dissatisfaction with managed care programs that restrict availability of certain therapies and time spent with practitioners has also led people to seek other avenues for the relief of their suffering (7, 8, 9, 10). Natural remedies fit perfectly into this new model of patient autonomy. Their ready availability without a prescription at drugstores, health food stores, and Internet vendors allows consumers to bypass the medical establishment and “prescribe” for themselves. Furthermore, many of these over-the-counter supplements are cheaper than their U.S. Food and Drug Administration (FDA)-sanctioned counterparts (and the payments for clinician visits). This may also contribute to their popularity.

Despite the growing interest in CAM, these remedies still meet with skepticism from many U.S. physicians, in part because of the relative lack of solid scientific data to support or refute these treatments, but also because of limited education on this topic during medical training (11). Asian and European physicians, on the other hand, are more knowledgeable about natural medications, and frequently prescribe them in their regular practice. South
America has, historically, also embraced the use of natural medications, as well as other alternative therapies for both medical and psychiatric problems (12).

The public’s collective faith in alternative medicine is impressive (4). No one has conclusively demonstrated the effectiveness of CAM as a whole, yet the sheer volume of devoted users belies the lack of supportive evidence. There is certainly no question that many individuals have benefited from judicious use of natural products, often as a last resort when conventional treatments have failed. For example, in psychiatry there are approximately two dozen FDA-approved antidepressants on the market, yet up to 50% of depressed patients will fail to respond to these drugs, and among those who do respond, many will relapse (13,14). Medication-related side effects, such as sexual dysfunction, stomach upset, and headaches, remain a significant obstacle to successful treatment with psychotropic drugs (15) and often result in premature termination of treatment as well as underdosing. Alternative agents, such as St. John’s wort, S-adenosyl-L-methionine, valerian, and others, could therefore prove a valuable addition to the physician’s armamentarium, given their apparent effectiveness—particularly for milder forms of depression and anxiety—and high tolerability (16). If properly researched and developed, carefully selected alternative treatments might reduce morbidity from illness, decrease hospitalization rates, and potentially save lives.

Unfortunately, research on these remedies has been limited by economic and political factors, and the relatively few published studies examining complementary therapies are often not rigorous enough to inspire a great deal of confidence among practitioners. The lack of strict government regulation with regard to efficacy and safety has also been an obstacle to systematic recommendation of these treatments.

SAFETY AND EFFICACY CONSIDERATIONS: THE FTC AND THE FDA

The key regulators of drug sales and food products in the United States are the FDA and the Federal Trade Commission (FTC) (17, 18, 19). These agencies share a common goal: to ensure accurate information that will protect the consumer from harm and/or deception. Both agencies scrutinize health claims about products, but do so from somewhat different perspectives. The FTC has jurisdiction over all products that are advertised in newspapers, television, and other media (except for drugs, which are strictly under the FDA umbrella) (20, 21, 22). The FDA, on the other hand, concentrates on the labeling that accompanies drug products, though the FTC may also have a share in the regulation of labels (21, 22, 23).

The FTC’s efforts are usually directed toward preventing unfair or deceptive practices, false advertisement, and labeling that is misleading (20). In a case of questionable advertising, the FTC must produce evidence of false or deceitful statements in an advertisement. They must first prove that a medical claim was made (e.g., “Chocolate Frosted Sugar Bombs cereal is low in fat and prevents hemorrhoids”), and then examine the evidence for and against that claim. In addition to reviewing the available scientific data, the FTC may perform a “copy test” to assess whether consumers believe a false or misleading claim. If enough consumers are mistaken in their interpretation of an ad, it may be termed deceptive and fines or corrective advertising may be mandated (21,23).

When asking for substantiation from the advertiser, the FTC must consider how costly it may be to support the claim about the product. For example, is a large-scale and expensive clinical trial necessary and feasible? Is the time period for assessment very long, as with cancer prevention claims? In many instances, the FTC may not require a rigorous clinical trial. For example, testimonials may be acceptable if they are real and come with disclaimers such as “results may vary.” In general, the FTC standard is that the “weight of evidence” must favor the claim made (20,21).

The main obstacle faced by the FTC is the inability to track down every unscrupulous vendor, particularly with so many residing on the Internet and myriad cable television channels (24,25). The FTC must be selective in its choice of targets, and tends to focus on products, such as ephedra, that have a higher risk of causing serious harm to consumers (21,26,27).

The FDA extracts higher, more concrete, and unambiguous standards of safety and efficacy from the products it regulates. While an FTC cost-benefit analysis must give only a “reasonable basis” for the claim, the FDA’s standard is more akin to “beyond a reasonable doubt.” If a manufacturer of a food or nutraceutical makes a disease claim (i.e., that the product will treat, cure, prevent, or mitigate a disease), the product is automatically reclassified as a drug and is subject to the FDA’s thorough and careful review process to ensure that it is safe and effective (23,28). Until the product is approved, it may not be marketed, and the FDA may seize the product if it is distributed prematurely (21).

A manufacturer who wants to make a disease claim must submit the claim to the FDA, along with an authoritative statement in its support and a balanced presentation of the scientific literature regarding the claim. Historically, the placebo-controlled, double-blind, randomized clinical trial has been the gold standard for testing drug efficacy (29) (see also Chapter 2). At least two such trials demonstrating superiority to placebo are generally required before the FDA will approve a drug for the market (30). Manufacturers who petition the FDA can usually expect an answer within 120 days of submission. The FDA may then (a) deny the claim and explain why; (b) allow the manufacturer to market the product; and (c) allow marketing, but design their own label for the product (21).

Only gold members can continue reading. Log In or Register to continue