Beware the Snake Oil

By Paul E. Lemanski, MD, MS, FACP

Editor’s Note: This is the 104th in a series on optimal diet and lifestyle to help prevent and treat disease. Any planned change in diet, exercise or treatment should be discussed with and approved by your personal physician before implementation. The help of a registered dietitian in the implementation of dietary changes is strongly recommended.

Medicines are a mainstay of American life and the healthcare system not only because they are perceived to work by the individuals taking them, but also because their benefit may be shown by the objective assessment of scientific study. Clinical research trials have shown that some of the medicines of Western science may reduce the risk of heart attacks, strokes and cardiovascular death.

In the first 93 installments of the Non-Medicated Life, certain dietary practices and a healthy lifestyle have been shown to accomplish naturally for the majority of individuals most of the benefits of medications in the prevention and treatment of chronic medical conditions such as hypertension, high cholesterol, pre-diabetes, diabetes and heart disease.

Unfortunately, the appeal of such evidenced-based interventions has been systematically undercut by the unscrupulous marketing and promotion of non-evidenced based products and supplements that promise improved health outcomes, but are no more likely to deliver than the proverbial snake oil. The article is an attempt to encourage appropriate questioning regarding health products and supplements, reintroduce skepticism regarding health claims, and better allow the buyer to beware!

Prior to 1906, Americans were subjected to unsubstantiated health claims regarding tonics, elixirs, and products that were described as “good for what ails you.” The only protection consumers had if those tonics, elixirs, and products were not “good for what ails you” came from their mothers and grandmothers who advised, “If something sounds too good to be true, it probably is too good to be true.”

In 1906, the U.S. Food and Drug Administration came into being ultimately to oversee the safety of food, drugs, medical devices and cosmetics. In 1951, an amendment was passed requiring a category of prescription or legend drugs that required a health care provider to oversee use. In 1962, an amendment was passed to assure the safety, efficacy and reliability of drugs, as well as standardization of names and allowing inspection of production facilities. In 1994, an amendment was passed to establish standards with respect to dietary supplements.

Supplements were defined as a product that contains “one or more dietary ingredients including a vitamin, mineral, herb, botanical or amino acid for use to supplement the diet or a concentrate, metabolite, constituent, or extract or any combination of the aforementioned ingredients.” Further, supplements were to be labeled as such and could not be represented for use as a food and could not be approved as a drug.

Unfortunately, unlike drugs, the FDA does not investigate or regulate the efficacy of supplements. Supplements may or may not work as described and the FDA generally has no say except for the most egregious claims – curing cancer would be an example. Moreover, the FDA cannot pull a supplement off the market unless it has well substantiated evidence of egregious harm or potential for harm. An example is the pulling of ephedrine containing weight-loss supplements from the market after multiple reported deaths. Additionally, the FDA does not routinely test supplements coming from other countries including China and India, and some of these products have in the past contained contaminants such as heavy metals known to be injurious to human health.

Because of the limitations placed on FDA by the 1994 amendment, and with the above in mind, consumers must exercise both caution and skepticism when it comes to the health claims of supplement manufacturers.

First, I would recommend that supplements and products coming from other countries generally not be consumed. You may consider use if supplied by an established practitioner of traditional Chinese or Ayurvedic medicine who can vouch for its purity as tested by an independent toxicology lab. Such caution should extend even to fish oil supplements from American companies. In 2012 Consumer Reports had an independent outside lab test the leading brands of fish oil and found that while none exceeded the lead, mercury, dioxins, or Polychlorinated Biphenyls (PCB) levels of the US, Pharmacopeia, total PCB in several products did exceed the more stringent testing required under California’s Proposition 65. Again, buying only those natural products that have been tested by an independent toxicology lab is prudent, although it does increase the cost.

Second, I would recommend that consumers be very skeptical of health claims made by supplement manufacturers who use the term, “clinically proven.” In more than one circumstance when I have called up companies to provide me with the evidence for the claim, I am provided with studies that lack a control group, or involve too few participants to establish statistical significance.

Consumers should be cognizant that supplements that are labeled with “This product is not intended to diagnose, treat, cure or prevent any disease” generally means there is no evidence to prove that the product works. Moreover, those products that are marketed using personal testimonial are also suspect, as personal testimonial does not constitute clinical evidence of efficacy.

Further, consumers need to know that the placebo effect – achieving a symptom improvement based on the belief a product will work – may be active in as many as 30% of those given a supplement and is not evidence for efficacy. For example, a trial to investigate a pill containing a soy supplement to improve menopause symptoms (e.g., hot flashes) in women compared results when women were randomly assigned to estrogen pills (known to work), sugar pills (the placebo control) and soy pills – all which appeared identical. The results: estrogen reduced symptoms about 90%, sugar containing pills about 30%, and soy containing pills also about 30%. In this case, soy worked no better than placebo and was probably working through the placebo effect. While many folks would not care if the placebo effect produced the desired result, it is not ethical to promote a result on the basis of a placebo, and it should be considered an unscrupulous marketing technique.

It is important to point out that the best ways to get vitamins, minerals, proteins, carbohydrates, fats, fiber, and the essential co-factors for biochemical reactions in the human body is through the consumption of whole foods that are minimally processed. For example, while pearled barley has a relatively slow release of carbohydrate into the blood stream, hulled barley (a less processed variation with the fiber and the germ of the barley adherent) is significantly slower. This slower release of carbohydrate into the bloodstream minimizes the rate of insulin release and thereby reduces the risk for stressing the pancreas and producing diabetes.

Finally, I would recommend that when deciding whether or not to use a supplement, patients should consult their personal physician who may best be able to help them balance any potential benefit from use, against potential risk. This conversation is especially important if a non-evidenced based supplement is being used in the place of a treatment known to work.

In summary – Unscrupulous marketing of non-evidenced-based products exists today despite the existence of the FDA. The 1994 amendment regarding supplements limits the oversight and protections that the FDA may employ. It is up to the consumer to apply caution and skepticism to all safety and efficacy claims of manufacturers of health products and supplements.

Awareness of the risks of relying on personal testimonial to establish efficacy and the possible confounding of results by the placebo effect is necessary to protect yourself. Even more, a healthy dose of skepticism regarding heath outcome claims and a willingness to discuss such claims with your primary care physician, is essential to avoiding the consumption of potential “snake oil” – and instead relying on evidenced-based lifestyle improvement to successfully live the Non-Medicated Life.

Paul E. Lemanski, MD, MS, FACP (plemanski3@gmail.com) is a board-certified internist practicing internal medicine and lifestyle medicine in Albany. Paul has a master’s degree in human nutrition, he’s an assistant clinical professor of medicine at Albany Medical College, and a fellow of the American College of Physicians.