Proprietary Perspectives: Ephedra: Eclipse, Macroeconomics And Enigma

By Anthony L. Almada | July 1, 2001

Sorting out the ephedra controversy.

Ephedra: Eclipse, Macroeconomics And Enigma

Sorting out the ephedra controversy.

By Anthony L. Almada

What dost thou sayeth—Ephedrine, prime mover of the genus Ephedra, fruit of its root, is friend to thine heart and foil to thine indulgences seen in thy growing flesh? Ye companies of cetacean size, what of thine economic health if the Ephedra sun is eclipsed by the dark moon of the lords of feast and medicines? What haveth thou that can fill the shadow of this omnipresent potion? How can thee assume this daughter of d-amphetamine is safe for ALL, even those presumeth to be “healthy”? With thine nation’s masses consuming thy fatness nemesis is it not inevitable that one of thine own children shall suffer an effectus adverseth?

My anemic attempts to produce Shakespearean rhetoric utterly crumble in the face of the Ephedra enigma. The line of battle lies within our industry; the internecine war of the naturalists and the industrialists has been waged since the “ephedra as stimulant trend” was born in the mid to late 1980s, driven by a now defunct company called Excel. Then emerged the “Pep” line, fueling new growth and a new type of diet products—in a solid dosage form “au naturel,” positioned against phenylpropanolamine (PPA), which happens to be a minor constituent of Ephedra extracts. Not until 1991 was the “thermogenic” badge affixed to Ephedra + caffeine combinations by KAL and a new category of products slipstreamed behind.

Companies have emerged out of the shopping mall, e.g. Metabolife, with enormous sales volumes spinning axially around this omnipotent plant. Other companies rest on the economic precipice, cliffhanging by the still intact but tenuous strength of the ephedra umbilical cord. Ephedra now appears in the delivery vehicle called chewing gum (which, based upon some research presented earlier this year with a caffeine-containing chewing gum, may increase the rate and amount of ephe­drine absorbed into the circulation). If ephedra was to be restricted from over the counter sale who would survive?

Is it unlikely that President Bush will authorize an economic impact report investigating the fallout that would ensue if the FDA chose to ban ephedra from OTC use in combination with caffeine? The sounds of falling stock prices, century-scale layoffs and consumer outcry would be deafening. If ephedra-containing products enjoyed national sales volumes of, say, less than $10 million in all channels, yet the number of adverse events associated and assigned to them was no different than the hundreds that exist today, would the FDA already have pulled it off the market by its roots?

Many of the naturalists quietly denounce the idea of ephedra being used as a stimulant and appetite suppressant/thermogenic. “It is a radical departure from the traditional, historical use of the plant. It bastardizes the traditional use developed by Oriental medicine and its practitioners. It drains the adrenals,” they say. Mind you, there appear to be NO studies anywhere in the world describing adrenal insufficiency/collapse among ephedra/ephedrine users, at least using Occidental measurement tools. With religious fervor these naturalists reserve ephedra for use with respiratory symptoms, to stimulate the heart and mind or as an anti-allergic. Who is to say they are incorrect?

Many of the industrialists espouse the idea of ephedra being used as a stimulant and appetite suppressant/thermogenic. “When properly used it is safe and more effective than the prescription drugs used to treat obesity. Many studies document its safety and efficacy, for periods up to one year or greater. As a jump-start, many individuals benefit from the effects of Ephedra + caffeine. They don’t need to take it for a protracted amount of time. It has kept many companies in our industry off the resuscitator,” they say. The first original research study evaluating the safety and efficacy of ephedra + caffeine combos was published just this March (Int J Obes). The second study was presented only this April, using only ephedra + caffeine (Kola nut) (Experimental Biology, Orlando, FL). Who’s to say the industrialists are incorrect?

Of the naturalists who advocate botanical extracts as superior to pure chemicals, they have no leg (or branch) to stand on when it comes to ephedra-delivered ephedrine versus laboratory “grown” (synthetic) ephedrine. The comparison trials examining safety and efficacy do not exist. Synthetic ephedrine, if present as the “racemic” dl mixture, or as d-ephedrine (ephedra that has not been adulterated contains only l-ephedrine), may be less prone to produce adverse events and more likely to elicit appetite suppressant and body fat reducing effects. Warner-Lambert has an “improvement” patent on this exact use, although it is questionable if it ever will be transferred to a live product.

What many fail to acknowledge on both sides of the battlefield is that only a few studies have been done with ephedra + caffeine examining safety and efficacy. ALL of the previously published studies on the topic used synthetic ephedrine + caffeine, with a 1:10 ratio seeming to be superior. The first study, which used Metabolife-356® as the test agent (delivering 63 mg of ephe­drine and 300 mg of caffeine/day, verified by chemical analysis), saw eight of the 35 subjects receiving this product drop out because of adverse effects. However, those that did endure the stimulant effects saw a loss of 7.7 pounds of body fat after eight weeks, compared to the placebo group, which saw only 1.5 pounds vanish.

In the second investigation, done by the same research group but with SIX MONTHS of supplementation, only about HALF of all the subjects completed the study. The test product here was a generic blend of ephedra (90 mg ephedrine/day) and 192 mg caffeine/day from kola nut (which happens to harbor other bioactive and potentially fat-relevant compounds). In this study, weight and fat loss again were far superior with the ephedra + caffeine combo yet only blood pressure was elevated throughout the study in this group, in comparison to the placebo group. This far more rigorous study found the product to overall be well tolerated, equally well tolerated in comparison to placebo and lacking adverse effects of concern.

Consumers seem to have ignored the media warnings over ephedra; sales remain strong and new brands emerge like wildflowers in spring. The attempt by some to introduce a safer ephedra “alternative” appears to be ineffectual. The marketing push behind Citrus aurantium extract, bearer of synephrine, lack proof of concept data in humans when administered alone and consumers do not appear wishful of swallowing the bitter orange pill in place of ephedra. The entity/person that does identify and validate an ephedra + caffeine blend with long-term safety (read phase IV/pharmacosurveillance studies) and/or a “substitute” for ephedra with equal efficacy, shall be a richer woman or man.NW

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