Natural medicines: will federal regulations help or hinder the natural products industry?

Editor's note: Marc Micozzi was a keynote speaker at the 1998 Mansfield Conference titled "The Healing Arts in American and Asian Cultures: A Conference on Living and Dying Well." This article was adapted from this lecture.

American consumers are rediscovering the appeal of natural medicines. From herbal remedies, to traditional Chinese medicine, to homeopathic treatments, people across the nation are spending their money on natural remedies to protect and enhance their health. "Rediscovered" is the key word because humans have used such products for millennia. Today, scientists, the media, and patients are interested in the possibility that a botanical may hold the key to curing such dreaded diseases as cancer or AIDS. However, without a focused, well-financed research program on natural medicines, and new federal regulations which treat these substances as medicines rather than foods, the full promise of these approaches may never be fulfilled.

As a physician, I believe that doctors are healers first. To help a client, they will use any ethical treatment that has been clinically proven to work. At present, these threshold criteria must eliminate many natural medicines because we don't have reliable information about their safety, efficacy, and formulations. For health care consumers, the situation may be even more frustrating. In many traditional societies, one or more members of a community may be experts on the properties and performance of natural medicines. But in contemporary America, consumers are on their own. Americans confront a bewildering variety of products that can differ significantly in their quality, usefulness, and sophistication, leaving consumers to sift through, sort out, and shift for themselves. Some might view this situation as purely the triumph of a free market, but from my perspective, this constitutes a potential health hazard that should concern everyone. From my perspective, the public health dimensions of the problem are important enough to justify a "crash program" of research. One complementary benefit of such an effort is that the natural products industry, which has received little help from the federal government to date, would ultimately have information that could help promote its products.

Natural vs. Pharmaceutical Remedies

The vast majority of natural remedies cannot be patented in the same way as products of the nation's pharmaceutical industry. This, in turn, provides little incentive for manufacturers to test and research their own products. It is also one reason that these remedies are regulated as foods rather than pharmaceuticals.

Critics contend that the industry is composed of agnostics - those who don't know and seemingly don't want to know the impact their products have on those who use them. But ignorance is not always bliss. When even a small number of deaths or adverse outcomes are attributed to natural remedies purchased over the counter in this relaxed regulatory environment, the damage to the industry's image is severe.

Given the unsettled state of affairs in the natural products industry, it is very important that patients inform their primary care physician about any natural products that they are taking on a regular basis. In the past, this was just the kind of information that patients withheld from their doctors. However, the Archives of Family Medicine recently published a study that indicates 50 percent of patients in a family practice clinic are now reporting the use of natural medicines to their physicians.

A brief look at lessons offered by both biology and history may be instructive. Evolutionary biology teaches us that organisms are designed to draw nourishment from the environment in which they grow.Plants serve human needs by providing oxygen to breath, as well as foods and medicines. It is interesting to note that in some traditional societies, no distinction is made between plants eaten to provide nourishment and those consumed for medicinal purposes. This creates an interesting link with our own recently discovered principle that nutrition is an essential tool in the prevention and management of disease.

Even casual students of history are aware of the vital role that plants have played in the shaping of American history. Efforts to establish the Massachusetts Bay Colony would surely have failed if Native Americans had not introduced the newcomers to several varieties of edible plants. By the time of the American Revolution, Dr. Benjamin Rush was recommending the maintenance of "physic" gardens, which contained Native American and European folk remedies. Less well known is the role that plants played during the Civil War. Once a Union blockade took hold in the latter days of the war, Confederate troops were low on pharmaceuticals and forced to rely on botanical remedies discovered by Native Americans.

When it comes to providing solid outcomes-based research on a variety of mainstream and complementary medical approaches, the U.S. Congress has made history in its own tight in recent years. To generate such information, Congress created the Agency for Health Care Policy and Research (AHCPR), an agency of the U.S. Public Health Service. A recent study conducted by the agency concluded that for low back pain, spinal manipulation techniques associated with the practice of chiropractic provide more effective relief than other approaches such as drugs and surgery. And patients referred by physicians for spinal manual adjustment are more likely than not to receive appropriate care. This study, and others like it, provides valuable information to physicians, patients, and medical consumers alike.

Research and Budget

As important as AHCPR's mission is, its budget is limited to $160 million a year. Such study results from an agency with a dedicated but relatively small staff and a tight budget provide insight into what might be accomplished by the behemoth of the federal scientific establishment, the National Institutes of Health (NIH). Unfortunately, the NIH as a whole has not shown great enthusiasm for outcomes research" associated with natural and complementary medicines. Congress has sought to spur the agency into action by creating a federal Office of Alternative Medicine (OAM) under NIH auspices.

As most scientists know, no document is more political than a budget. To understand relations between NIH, OAM, and AHCPR, it helps to look at the numbers. The OAM has an annual budget of just $12 million at a time when the NIH budget is $12 billion. Such an amount does not go far when the goal is to conduct scientific research on a full range of complementary medicines. To view these figures from a different perspective, Americans spent $17 billion on complementary-medicine products in 1996, according to Nutrition Business International, a trade association headquartered in San Diego. Such products should be the focus of studies conducted by scientists.

In reality, we are allowing unwary American consumers to field-test these products for us. Whether one views this from the perspective of health policy or medical science, this approach is inadequate and inappropriate when it comes to the health of Americans. This challenge is serious enough to justify a joint effort by government, industry, universities, and think tanks to find better ways to provide information that is largely unavailable now.

One bright spot on the horizon is that a variety of federal agencies are beginning to recognize the need for this kind of research and have the capability to do it. To get a clearer sense of the bigger picture, U.S. Sen. Arlen Specter, R-Penn., has requested a federal governmentwide survey of all research activities concerning complementary or alternative medicine.

Since many experts agree that we need additional scientific research on the safety and efficacy of natural remedies, we can also save both time and money by reviewing credible scientific research that has been done abroad. Among the countries that have done such research are Germany, China, Nicaragua, and Vietnam. Germany has set the standard for scientific research for most of the last two centuries, and there is no credible reason for failing to investigate German research. In this instance, the German government appointed a regulatory commission known as Commission E and asked it to conduct scientific studies on hundreds of plants that are being used as medicines. These monographs have been completed and are now being translated into English by the American Botanical Council, a nonprofit educational organization. This research may help to provide answers we have been seeking for years.

Federal Regulations

At this juncture, two federal agencies, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are trying to take a more discriminating approach to regulating the natural products industry. These agencies need more statutory authority and larger budgets to do the job. From the perspective of public health and patient care, this would constitute a strong, positive step forward. There is little doubt that the quality, consistency, and safety of natural medicines can be improved. If these products were regulated like pharmaceuticals, they would be subject to the clinical studies that the FDA uses to test the safety and efficacy of potential new drugs in humans. The greater good will ultimately be to have better data, greater acceptance, and increased integration of natural products into the health care system for the benefit of all.

However, to date the natural products industry has resisted efforts to subject itself to federal regulation. From my vantage point, this is both an unnecessary and self-defeating policy. Better federal regulation is the best thing that could happen to this industry. Here's why:

1. The economic growth that the industry has experienced in the last decade is limited compared to the growth it could experience if the efficacy of some if its products were confirmed by scientific evidence and accepted by the medical community. Many Americans who resist buying these products will begin to do so if they are recommended by physicians. It is useful to remember that many of the scientific studies done on these products have surprised many mainstream health experts by beginning to validate the efficacy of natural products.

2. As present, the natural products industry may be compared with a bustling frontier town in 19th century America. Many residents of this community were decent law-abiding citizens, but a handful were dangerous characters whose behavior cast doubts on the town's reputation and the desirability of the neighborhood. If many members of the natural products industry sell useful products that help customers, it is currently hard to distinguish between them and those industry members who sell useless products - or don't really know what they are selling - and cheat customers, and damage the reputation of the industry as a whole. Raising standards will strengthen the industry, expand and improve opportunities, and benefit those who are most responsible.

3. As the recent experience of the organic food industry demonstrates, it is unlikely that the natural product industry can continue to avoid federal regulation indefinitely. It has the option of reaping the political and public benefits of attempting to work with the government on regulatory concerns, or eventually reaping the negative consequences that come from being forced to yield.

4. Some members of the natural products community cling to an outdated idea that all government officials have a hostile, adversarial attitude toward the community and complementary medicine in general. Some even suggest that Americans need to be protected from the FDA, and that the agency cannot adjust to the fact that one-third of the population now uses herbal products on a regular basis. This view implies that the FDA - and perhaps the government as a whole - constitutes a kind of inflexible monolith, but historical evidence indicates otherwise. On issues ranging from acupuncture to spinal manual therapy, AHCPR, FDA, and the NIH have all shown that they will ultimately respond to scientific evidence. In recent years, officials at both the FDA and the FTC have made a point of reaching out to responsible elements of the complementary medicine community in an effort to foster a continuing dialogue. Federal regulators and members of the natural medicine community will not agree on every issue, but the regulators have indicated a real desire to listen and to try to be fair and more discriminating.

Those who market natural products can best serve themselves and the public by truly standing behind the products they sell. Working with federal regulators is one way to help do so, but this also means investing some money (now spent on marketing) toward research. An industry which is estimated to generate $17 billion a year should be able to justify doing so in light of the ultimate balance of economies and health risks and benefits.

Marc S. Micozzi, M.D., Ph.D., is the executive director of the College of Physicians of Philadelphia.