October 20, 1998

Alternative Medicine: The Risks of Untested and Unregulated Remedies

Posted in: Health and Nutrition

Contained in this document is an article followed by two opposing viewpoints on alternative medicine.

by Marcia Angell, M.D. and Jerome P. Kassirer, M.D.
©1998, Massacusetts Medical Society

Published in 9/17/98 edition of the New England Journal of Medicine.
Summarized here by Dan Roberts

What most sets alternative medicine apart [from conventional medicine] is that it has not been scientifically tested, and its advocates largely deny the need for such testing. Many advocates of alternative medicine believe the scientific method is simply not applicable to their remedies. They rely instead on anecdotes and theories which lack documentation.

Alternative medicine also distinguishes itself by an ideology that largely ignores biologic mechanisms, often disparages modern science, and relies on what are purported to be ancient practices and natural remedies (which are seen as somehow being simultaneously more potent and less toxic than conventional medicine.)

Of all forms of alternative treatment, the most common is herbal medicine. Until the 20th century, most remedies were botanicals, a few of which were found through trial and error to be helpful. But therapeutic success with botanicals came at great human cost. Many of the remedies simply did not work, and some were harmful or even deadly.

With the rapid advances in medical science in the 20th century, plus the development of the randomized, controlled clinical trial, no longer do we have to rely on trial and error and anecdotes. We have learned to ask for and expect statictically reliable evidence before accepting conclusions about remedies. Without such evidence, the FDA will not permit a drug to be marketed. Largely as a result of this development, life expectancy has increased by three decades in less than a century.

Now, with the increased interest in alternative medicine, we see a reversion to irrational approaches to medical practice, even while scientific medicine is making some if its most dramatice advances. Fortunately, most untested herbal remedies are probably harmless, and are being used by people who are healthy or who have relatively minor problems. Still, uncertainty about whether symptoms are serious [enough to consult a doctor] could result in a harmful delay in getting treatment that has proved effective. And some people may embrace alternative medicine exclusively, putting themselves in great danger.

In 1994, Congress exempted “dietary supplements” from FDA regulation. Since then, these products have flooded the market unregulated, with the only legal requirement being that such products not be promoted as preventing or treating a disease. The FDA can intervene only after a product has been shown to be harmful.

It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine: medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.

Response by Dr. Andrew Weil, Nutritionist

I was disappointed to see the New England Journal of Medicine disparage alternative medicine and its advocates. The recent editorial reflected a fear that I believe many in the medical establishment feel about trends in medicine today. Patients are tired of supporting the capital-intensive medical system when the results are often disappointing. Patients are also asking questions that doctors are simply not trained to answer.

The Journal’s assertion that advocates of alternative medicine don’t want their methods to be researched is absurd. We do. Just give us the funds, facilities and personnel to do the job! With regard to botanical medicine in particular, a lot of data already exists to support therapeutic safety and efficacy, but most doctors in the U.S. don’t know about it. Our colleagues in Japan, Germany, France and Russia, for example, have left the Amercian medical establishment in the dust when it comes to research in this area. A first step would be to collect the existing information and make it more widely known.

The fact is that millions of consumers in America have turned to natural supplements and alternative therapies, yet in the absence of trustworthy information, people are left to get information from any source the can. In some cases this information is good, but often it’s not. What we need now are physicians and pharmacists trained in these modalities who are able to help their patients rather than further estrange them. That’s just what I’m working on in the integrative medicine program at the University of Arizona.

But I also must agree that the dietary supplement industry need regulation. Whether that regulation comes from an independent unit of the FDA that is free from the influence of the pharmaceutical lobby or from a nongovernmental organization such as the American Botanical Council that can operate as an industry watchdog, the point is there are currently too many products on the market of questionable quality and too many for which misleading and unsupported claims are being made.

For herbal medicine to gain the legitimacy it deserves, manufacturers must produce standardized products containing exactly what labels say they contain and make no more claims than the evidence supports. So far the industry has not shown that it is capable of policing itself. Ultimately no one would be better served by intelligent regulation than the supplement industry itself.

Response by Linda Kaspari, Editor, Focus Newsletter

Thank you for allowing me the opportunity to respond to the recent editorial which was published in the September 17 edition of the New England Journal of Medicine on alternative medicine.

Most individuals first become familiar with the term “Alternative Medicine” when they face a diagnoses which is considered incurable or untreatable. With conventional medicine offering no treatments or cures, patients begin to look elsewhere. Patients today have begun to accept more responsibility in the role they play in there general health conditions and disorders.

Alternative medicine, or what I prefer to call nutritional medicine is a learning process. A lifestyle change and a healthy diet may be enough for a healthy individual who wishes to maintain good health. However, Most individuals with eye disorders are finding a lifestyle change and nutritional supplementation to be more beneficial.It is not a simple process of rushing to the local supermarket or drug store to find the most popular brand of vitamins on the shelf. Each patient needs to educate themselves on which nutritional supplements are the purest and most absorbable brands. Each patient needs to understand which nutritional supplements may be the most beneficial and the importance of seperating these nutritional supplements with different meals so they do not compete for absorption in the digestive tract. Each patient needs to be educated on which nutritional supplements may increase light sensitivity when taken in high dosages, and each patient must also learn the importance of safe recommended daily dosages.

Let’s first take a look at the patient advocates perspective. Our greatest needs are to break the barriers which prevent us from having open communication with our physicians.

Many patients have found themselves trying to explain to their doctors the vision improvements they are experiencing with a lifestyle change and a daily nutritional supplement regimen, only to be scolded or told they are having a placebo effect. Many people become frustrated with the lack of interest from the care giver and find it more productive to network and educate other patients with the same disorders through testimonials, discussion groups and support groups.

It is wise to consult your physician before starting a nutritional supplement program, however, most physicians are trained by the drug companies and are not educated in nutritional medicine. It is sometimes difficult for your physician to recommend nutritional supplements because of a lack of knowledge.

There certainly is not a lack of scientific evidence available on the importance of nutrition. More and more evidence continues to present itself. The Schepens Eye Research Institue say that “Vision loss associated with aging may be preventable – even reversable – through improved nutrition”. Dr. Hammond states that “Our studies have suggested that individuals differ in their ability to absorb nutrients from food to their tissues”.

Dr. Stuart Richer says that new research indicates the most common form of macular degeneration can be diagnosed before it destroys vision and treated successfully with, all things, spinach. Dr. Richer says that Lutein found in dark green leafy vegetables works because it increases the density of macular pigment in most people. Lutein and other nutrients are available in many multi-vitamin ocular formulas.

Dennis R. Hoffman, Ph.D. of the Retina Foundation of the Southwest (Dallas, Texas) has been conducting such trials for the past ten years primarily to understand the interactions of omega-3 fatty acids with visual function in the infant diet. Based on the research results in their lab,together with that of many other investigators over the past two decades, they have proceeded to investigate the actions of these fatty acids in patients with the most severe form of retinitis pigmentosa (RP), namely X-linked retinitis pigmentosa.

H.J. Roberts M.D. reports his findings on the importance of avoiding a well known retinal toxin “Aspartame” in an article titled “What’s Blinding the World”, this article is on line at Focus Newsletter

In two major studies published in the “Journal Of The American Medical Association” each report reached the same conclusion that “Smoking Is A Major Cause of Age Related Macular Degeneration”. Another study shows that avoidance of this known retinal toxin will sharply improve night vision in smokers.

Dr. Stuart Richer and medical journalist Bill Sardi have written a 48 page documentary for FOCUS which is backed by 170 citations from the medical literature suggesting a more alternative approach to the family of retinal disorders which include the application of antioxidant medicine, antiviral protocols, avoidance of known retinal toxins, evaluation of the digestive tract and supplementation of lutein and DHA-rich omega 3-fatty acids. This documentary offers new direction and documents the science behind their application as well as their saftey.

And last I would like to also mention that today conventional medicine and nutritional medicine are combining their practices in what is called “Complementary Medicine”. It is to all of our advantage to encourage nutritional medicine. It may provide answers we are all looking for in our battle against retinal degeneration.

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