Is There An Alternative?
"I propose that alternative medicine be defined as a broad set of health care practices (i.e., already available to the public) that are not readily integrated into the dominant health care model, because they pose challenges to diverse societal beliefs and practices (cultural, economic, scientific, medical, and educational)" (Eskinazi, 1622). This wide-ranging definition for alternative medicine was introduced with the publication of the November 11th issue of the Journal of the American Medical Association; it shows the complex nature of integrating these treatments into the mainstream medical community. This complex definition is presented to the degreed readership of the journal in an attempt to receive feedback from that readership, it is not written in stone. Still there is no carefully thought out definition for the country's doctors to follow. Unfortunately the idea of integration is still far off, "Sharp distrust has long characterized much of the relationship between practitioners of mainstream and alternative medicine" (Castellicci 1036). So even if patients were to ask their doctor's advice about an alternative treatment they might just be turned away from trying anything different. The treatments that are classified as alternative are in great use today and increasing more every day. Even Congress, trying to set some guidelines, authorized the FDA to prescribe safety standards - officially called Good Manufacturing Practices, part of the passage of the Dietary Supplement Health and Education Act of 1994 (Moore, 63). But this did more to open up the supplement industry, allowing for more self-regulation than government control. With this in mind lets look at the basic types of alternative medicine.
There are three basic alternative treatment options, hands-on therapies, mind-body medicine, herbal healing and lifestyle approaches (Dillard, 40). Hands-on includes chiropractic, acupuncture, and massage. Mind-body encompasses relaxation techniques, meditation, and hypnotherapy. Herbals and lifestyle changes deal with herbs and botanicals, aromatherapy, nutrition and diet. "If low-cost interventions such as lifestyle changes, diet, supplement therapy, and behavioral medicine can be delivered as substitutes for high-cost drugs and technological interventions, true cost reductions and the compression of morbidity might be achieved." (Jonas, 1617). Can we achieve the saving of money and lives through these alternatives? Perhaps, but all is not as it seems. Problems arise from these treatments especially those of the third type, herbal healing.
The healers and medical practitioners through-out the ages have used plants and herbs to treat illness, "even our own medicines used today have a plant base." (Dillard, 41). The power of plants and herbs for medical uses is well known to health care practitioners today; it's the general public's lack of knowledge that is the true concern. "Don't dose yourself with herbs unless you know what you're doing (or, better yet, are under the supervision of a professional who does). " (Dillard, 234). Then there's the problem of efficacy. Do, or can, these herbal treatments actually have a healing effect against illness. A Mayo Clinic cardiologist Raymond Gibbons speaking of people taking garlic pills for the treatment of chronic chest pain, known as angina says, "These (alternative) therapies are being touted in various ways, and patients are easily misled into thinking that"…"they can substitute them for existing standard care." (Lerner, 6A). Finally there's the major problem of assuring quality manufacturing. "No quality standards are in place to ensure (that) the products don't have dangerous pesticide residues, chemical contaminants, or heavy metals such as lead or mercury" (Moore, 60). The major problems associated with the use of herbal dietary supplements - such as, a lack of consumer knowledge, a lack of rigorous evidence of efficacy, and no set standards to maintain quality manufacturing practices - must be addressed, at least, by more public education and, more importantly, by a substantial review of national legislation.
Quality standards for herbals and botanicals are more than just the cleanliness of the factory floor, when used as medicine the standards can mean whether the consumer receives the benefits touted or something much more dangerous to his or her health. "When a young woman developed dangerously irregular heartbeats, the FDA traced the problem to a plantain-based herbal laxative called Chomper, which mistakenly included (a powerful heart drug called) digitalis. A further check found digitalis in plantain-based products from seven different manufactures or distributors - and in bottles at more than 100 different retail outlets." (Moore, 63). The plant plantain, a mild laxative, and the weed foxglove, the base for digitalis, look very similar; something as simple as picking the wrong plant can have dangerous effects. This problem wasn't even thought of until something had happened to a consumer, then it was found to be widespread. Steps were never taken to ensure that something like this could not happen in the first place, preventive measures were never deemed necessary. "Other botanical quality problems include getting the wrong part of the plant, growing the plant in the wrong place, harvesting at the wrong time of year, or storing it improperly so it loses potency" (Moore, 64). It's very easy to create a health problem with the widespread use of freely growing herbs that aren't as closely monitored as the lettuce in our salads. Pesticides used on products that are destined for human consumption, (i.e. food plants), are tested and registered with the Environmental Protection Agency. Allowable limits for their use are set. When we go to a supermarket and purchase these items we know to wash them when we get them home, that is not possible with a highly processed tablet in a bottle. "But there are no registered pesticides for most botanical products. That means what is used, how much is used, and whether any residue remains after processing for human consumption is anyone's guess" (Moore, 64). Any pesticides used in the growth of most botanicals are not listed with any government agency and the consumer would have no knowledge of their use.
Even if the product was manufactured properly and it makes it to the store shelf with the right ingredients in the bottle it doesn't mean that what's inside will do you any good. Pedro Delgado, director of the UA Research Program in Psychiatry and Clinical Neuroscience, said about the popular alternative treatment for depression St. John's Wort, "The biological mechanisms of the way St. John's Wort works in the brain are not well understood" (St. John's Wort, B8). He also states that further study must be done to find out if the drug actually works.
This problem of efficacy was discussed in great detail by all the major parties involved at a meeting in Washington DC where herbalists, manufactures, processors and distributors of botanicals and representatives from the FDA met. Varro E. Tyler, PhD, Lilly Distinguished Professor of Pharmacognosy at Purdue University, West Lafayette, Ind. said, it's because it is so expensive to prove a new drug safe and effective that, ""…"without patent protection nobody would be willing to do an efficacy trial." (Marwick, 608). Botanicals do not have to be marketed as drugs to be tested more than they are now. Dr. Tyler says, ""…"he was not proposing that botanicals be marketed as medicinals without any effective data, but reasonable evidence of effectiveness should be acceptable" (Marwick, 608). Robert Temple of the FDA's Office of Drug Evaluation and Research, responding to Dr. Tyler, says that he disagrees with the notion that testing for efficacy is overly expensive, "To say that it costs $350 million to work up a drug is absurd. This figure is put out by the drug industry to show how expensive it is to stay in business. Some trials are not as expensive as you might think, since you don't necessarily have to make large numbers of observations"…"one or two well-designed clinical trials could be useful" (Marwick, 609). Another member of the meeting talked on a more personal nature of patient and doctor interaction, "We need to do trials," said KaKit Hui, MD, director, UCLA Center for East-West Medicine, UCLA School of Medicine. "But if we have to wait for all the studies to come in to provide guidance for our patients then we are in trouble. Many people are taking herbs on their own, so adverse reactions can occur." (Marwick, 609). Less than a year before this meeting the New England Journal of Medicine gave its opinion on testing of efficacy, "There cannot be two kinds of medicine - conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments" (Angell, 841).
The only one who hasn't been spoken about yet is the consumer. There would be no problems associated with the use of any treatments if simple and clear-cut thinking were used by the one group of people that the treatments are trying to help. Dr. Dillard clearly spells out what's needed, "Don't dose yourself with herbs unless you know what you're doing (or, better yet, are under the supervision of a professional who does)"…"don't expect the clerk in the health food store or supermarket to know what's right for your particular body either - or whether this new product will interact with some treatment you're already using." And ""…"be sure to tell your regular MD about which herbal remedy you're planning to use -- and how much of it." (235). But how many people are taking the time to read up on some treatment that they might, just on a whim, pick up at the market? The public's right to know is unquestioned in this country, but they have to pose some questions on their own.
Because of the growing popularity of alternative treatments, in 1997 42% of Americans used some form of alternative treatment, and 39 million people sought treatment or advice from an alternative medicine practitioners, up from 22 million in 1990. (Arnold, 1104), these basic problems that I have specified must be addressed quickly. The safety and purity issue can be thought of this way, with the lack of government controls over the growing and tending of botanical crops couldn't we just use the same agricultural safeguards that are in place for the harvesting of salad ingredients? Why is it that something that is intended for human consumption, like lettuce, is controlled by more safeguards then something that eventually is consumed by the same public and is basically grown the same way? Just the idea that the pesticides that would not be allowed on food crops can be used on botanical crops should raise some concerns. The final outcome of these botanical crops is that humans will consume them, their growth process should be as closely monitored, and all aspects of the processing of these products should be under stronger good manufacturing practice guidelines. We have seen enough problems associated with this aspect of herbal treatments that we can not let self regulation by the industry be the rule, too much is at stake. Writing in the opinion section of the Washington Post, the Texas Commissioner of Health William R, Archer III said it this way,
It is time for Congress to expand the Dietary Supplements Health and Education Act of 1994. It should free the Food and Drug Administration to establish national testing and safety requirements that will allow the public to use beneficial dietary supplements and herbal products with some degree of confidence that the products are generally safe and effective when used as directed. Currently, the law allows products on the shelf that have not been tested, leaving the public ill-informed of any risks, uncertain of the validity of any claims and wondering if the manufacturer's recommended dosage is safe. (Archer, A22)
He went on to add that we have not used caveat emptor (let the buyer beware) with our foods and drugs. We should not use caveat emptor with our dietary supplements and herbal health products.
In the end what can the government do when faced with the challenges posed by the diverse societal beliefs and practices that are inherent in the nature of these treatments? The FDA has guided toward self-regulation, Congress seems to agree, but problems have arisen from this stance. Doctors and politicians alike are calling for stricter rules to govern the manufacturers and perhaps even the public's ability to easily acquire these treatments. Can we rely on good common sense from patients and the general public to make sure that what they take is necessary and will not interact with any other medication they may be taking at the time? How would the public have any way of knowing what manufacturing process was used to put this herb on the store shelf, how can they know it was safe? These questions are too important to be left to individuals who will monetarily benefit from their answer. As Commissioner Archer has stated, Congress should expand the Dietary Supplements Health and Education Act of 1994.
Works Cited
Angell, Marcia. "Alternative Medicine - The Risks of Untested and Unregulated Remedies." : The New England Journal of Medicine. 339 (1998): 839-841.
Archer, William III. "Rules for Dietary Supplements." Editorial. The Washington Post. 31 May 1999: A22.
Arnold, Katherine. "Alternative Medicines Gain in Popularity, Merit Closer Scrutiny." : Journal of the National Cancer institute. 91 (1999): 1104-1105.
Castellucci, Laurent. "Practitioners Seek Common Ground in Unconventional Forum." : Journal of the National Cancer Institute. 90 (1998): 1036-1037.
Dillard, James MD, DC, CA. Alternative Medicine. Foster City: IDG Books Worldwide Inc., 1998.
Eskinazi, Daniel P. "Factors that Shape Alternative Medicine." : Journal of the American Medicinal Association. 280 (1998): 1621-1623.
Jonas, Wayne B., MD. "Risks of Conventionalizing Alternative Medicine." Journal of the American Medical Association. 280 (1998): 1616-1617.
Lerner, Maura. "Heart Doctors Say Alternative Remedies Are Not Effective." Minneapolis Star Tribune. 28 May 1999, metro ed.: 6A.
Marwick, Charles. "Growing Use of Medicinal Botanicals Forces Assessment by Drug Regulators." : Journal of the American Medical Association 273 (1995): 607-609.
Moore, Thomas J. "Messing with Mother Nature." Washingtonian. July 1999: 58+
"St. John's Wort: Cure, Placebo, Possible Danger?" Editorial. The Arizona Republic. 23 July 1999, final ed.: B8.