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Natural Remedies: Who’s Watching the Store?

Posted Oct 27 2009 4:43am

By Barbara Berkeley

Let’s have a show of hands. How many of you have a history with dietary supplements or “natural” remedies? Ever tried that miracle pill for weight loss that beckons so alluringly from the pages of your favorite magazine? What about Metabolife? Hydroxycut? TrimSpa? Colon cleanses? Weight loss vitamins? Supplements for sexual enhancement? Natural remedies for menopause?

These products are sold over the counter and over the Internet. Because a doctor’s prescription isn’t necessary, they appear to be safe. But are they? The fact is that there is so little oversight of natural and herbal products that it’s impossible to know.

According to a Harris poll, the majority of American consumers believe that over the counter dietary supplements are monitored by a government agency like the FDA. Two thirds of consumers believe that supplements are required to carry warning labels about harmful side effects. Neither belief is true.

Physicians are also relatively uninformed about supplement safety. About one third of medical residents in one survey were unaware that herbal remedies were unregulated and the majority did not know that it was their job as physicians to report suspicious side effects to the FDA.
In 1994, Congress passed what many believe to be an unfortunate piece of legislation. Called DSHEA (the Dietary Supplement Health and Education Act), this act removed much of the FDA’s power over supplements. Prior to this time, herbal products were treated as food additives and manufacturers were required to show proof of safety. With the advent of DSHEA, over the counter supplements were assumed to be safe and therefore to require no governmental regulation. In other words, it was now the responsibility of manufacturers to police their own products.

The politics which led up to the passage of DSHEA are compellingly documented by NYU professor Marion Nestle in her book, “Food Politics.” This is a weighty book, but one that I heartily recommend to those of you who are interested in the powerful interests behind the foods we eat. Suffice it to say that, in the case of DSHEA, those with a financial interest in keeping supplements deregulated won the day. Now, in an era when big bucks can be made from treatments for obesity, erectile dysfunction and other lifestyle related conditions, we have a growing and largely uncontrolled problem.

According to an October 15 editorial in the New England Journal of Medicine:

“…a wide range of dietary supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Of particular concern are the dozens of dietary supplements that are contaminated with prescription medications, controlled substances, experimental compounds, or drugs rejected by the FDA because of safety concerns.”

Weight loss remedies and sexual performance drugs are among the top candidates for potential contamination. As of July , the FDA had an alert on 75 contaminated weight loss supplements. And the tampering was not minor. The NEJM article cites a natural remedy which actually contained over three times the recommended daily dose of the prescription drug Meridia. Other drug contaminants included unapproved anorectics, diuretics, antidepressants and tranquilizers.
A major concern for patients taking contaminated supplements is drug interaction. When physicians prescribe medication, pharmacies and doctors check to make sure that patients are not taking drugs that can be harmful when used together. Because so many of those looking for weight loss also suffer from hypertension, elevated sugar, cholesterol problems, GERD and the like, this population is often taking other medications when they add a supplement. This puts overweight supplement users at increased risk for interaction with hidden drug contaminants. Drug interactions can be very serious. In the Fen-Phen days, for example, we learned that the combination of two relatively benign weight loss medications led to irreversible heart valve damage.

In order to evade the FDA, supplement manufacturers have turned to doctoring their supplements with drugs which have been slightly altered so as to avoid chemical detection. The problem with these newly altered compounds is that they have not been previously tested for human use. According to the NEJM for example, a changed form of fenfluramine (a diet medication) found in supplements was linked to severe liver failure in various reports.

I have always been puzzled by the public’s willingness to take over-the-counter remedies and supplements. Recently, a company that I’d never heard of sent me some sample diet cookies. They came in a box, each one in an open cellophane sleeve along with a little printed information sheet. Forget it! I wasn’t eating those nor would I allow any of my staff to consume them. I’m probably on the extreme end, but I am suspicious enough of the safety of plain old food without adding unknown substances to my diet. My gastroenterologist husband is always taking care of people with salmonella, e. coli and other forms of food poisoning. And those are from foods that ARE regulated (although not enough…a subject for a future post).

Whenever we swallow something, we are giving that substance a pass key to our bloodstream, our heart, our brain. Should we really trust pills and potions whose provenance is uncertain at best? Even in the best of circumstances, natural does not mean innocuous. Remember that many potent medicines are herbal, including digitalis which helps the failing heart contract, and yew which yields a potent cancer chemotherapy. Add to this the issues of uncertain quality control and hidden contaminants and we have an industry in dire need of regulation. In this cynical age we must consider the possibility that some supplement providers may be more interested in our dollar than in our health. At this moment, there is little guidance to help us distinguish the good from the bad. Unfortunately, it appears that the bad can be very bad indeed. Until the current regulatory situation changes, the burden is on each of us as individuals to take a long, critical look at the “cures” we choose to swallow.

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