EPHEDRA: Another View

By Jerry McLaughlin, Ph.D.
NSP Vice President R&D/QA/Chief Scientific Officer

From Sunshine Horizons, Nov/Dec 2000, p. 4-5

[Dr. McLaughlin presented this paper in an Open Meeting of the U.S. Public Health Service in Washington, DC, on Aug. 8-9, 2000. Prior to the meeting there was a call for testimony. Speakers volunteered to present their views and findings on ephedra. An estimated 500 people from both sides of the ephedra lobby were in attendance. ? Several other trade organizations, vendors, and individual consumers were present, lending credence to the beneficial, even life-changing, effects of ephedra.]

Ephedra products contain a mixture of phenyipropanolamine alkaloids called ephedrines. These compounds, composed primarily of ephedrine itself, promote the release of norepinephrine from sympathetic nerve endings. They induce a number of pharmacologic responses, including vasoconstriction, hypertension, nausea, vomiting, increased heart rate, bronchial relaxation, urinary retention, nervous stimulation, and anorexia (loss of appetite).¹

Two of these effects, bronchial dilation in asthma and anorexia for weight loss, have current practical applications, but the other actions must be remembered as potential undesirable side effects. Consumers of ephedra products have experienced rare cardiac (heart attack) and circulation (stroke) problems, but the FDA consultant physicians, upon evaluation of 1,133 reported adverse effect reports (AERs) over the past 10 years, have concluded that these adversely affected consumers had pre-existing conditions that were exacerbated by the vascular and cardiac side effects of ephedra.² The incidences of such adverse effects are extremely rare (nine associated deaths in the past 10 years) considering that over 3 billion doses of ephedra are consumed per year for weight loss.

Nature's Sunshine Products sells over 500 different natural supplements with gross sales approaching $300 million per year. Ten of these are weight-loss products, which contain herbal ephedra mixed with other ingredients. In 1998, 629,430 units of these products, representing about 28,324,350 doses, were sold. Our Customer Service department logs over 360,000 inquiries per year, and in the first six months of this year only eight complaints were received regarding our ephedra products. Of these eight, only four (complaining of nausea and vomiting, nervousness, water retention, and heart palpitations) were attributable to ephedra.

We have a team in our Research and Development department that handles technical inquiries; this group fields about 500 questions per month, and, in the past one and one-half years, they have logged nine complaints attributable to ephedra; five of these concerned heart palpitations.

From early 1993 to October 1998, the FDA's special nutritionals adverse effect monitoring system (SN/ALMS) tabulated 11 AERs for Nature's Sunshine ephedra products. These effects included hypertension (2), headache (3), nausea (1), nervousness (3), and heart palpitations (2). Considering the millions of doses consumed, it can be concluded that the number of adverse effects due to the use of our products is trivial, and no deaths have been associated with this use.

We believe that this good safety record can be attributed to several factors: 1) our products contain ephedrines exactly as labeled;³ 2) our labels explicitly inform our consumers of potential cautions; 3) caffeine and other stimulants, which might adversely synergize with the ephedrines, are not included; and 4) our policy of "people helping people" provides wise counsel and advice, along with product, to our consumers.

In view of the sensationalism created by the FDA and the media over the purported side effects, the beneficial effects of ephedra, as an aid to weight loss, are being unjustly ignored. Of the 2,300,000 total deaths recorded in 1997 in the U.S., some 955,021 (42 percent) were attributed by the Centers for Disease Control (CDC) to conditions that typically emanate from obesity (heart disease, hypertension, stroke, and diabetes). According to CDC statistics some 54 percent of the adults in the U.S. are overweight, and the mortality due to obesity is certainly a greater danger than the rare incidences of stroke or heart attacks attributed to temporary consumption of ephedra products. Thus, ephedra products for weight control clearly offer a favorable ratio of benefit to risk, and that ratio is equivalent or superior to anything else that is available to the U.S. consumer as an anorexiant (appetite suppressant). The drug abuse potential of the amphetamines like dexedrine and the pulmonary hypertension and damage to heart valves induced by fen-phen serve as examples of the dangers of anorexiant products offered by the pharmaceutical industry and blessed by FDA approval. The overall incidence of serious adverse drug reactions (ADRs) is 6.7 percent and that of fatal ADRs is 0.32 percent of hospitalized patients.⁴ Such synthetic products are major culprits in killing 106,000 hospitalized patients per year by adverse drug effects. Such facts give the U.S. consumer little confidence in the FDA seal of approval, and the DSHEA law of 1994 provides us all with a safer alternative in the form of natural dietary/nutritional supplements which can be chosen directly by the consumer without the inconvenience, expense, and risk of consulting physicians and buying prescriptions.

To put into proper perspective the relative importance of adverse effects, we remind the media and the FDA of the inherent dangers of a common OTC [over-the-counter] drug such as acetaminophen, the pain reliever found in Tylenol?. Overdoses of acetaminophen quickly deplete the liver of glutathione and necessitate the administration of antidotal acetylcysteine. The American Association of Poison Control Centers in 1998 recorded 111,454 reports of such overdoses with 153 resultant deaths. Accurate statistics are not available regarding the number of acetaminophen doses consumed per year, but it can be estimated at about 6 billion compared to about 3 billion doses of ephedra products used for weight loss.

Since headaches and mild pain are not real threats to human life (and obesity is), one could question why such a dangerous product as acetaminophen is tolerated and why ephedra products, which pose far less of a health threat, are under the current scrutiny. Might the answer lie in a combination of zealousness on the part of the FDA in their quest to encumber herbal products with bureaucratic over-regulation and in a press and news media that finds it necessary to feed something sensational every day to the consuming public whether it is real, exaggerated or concocted?

1. Rubbers and Tyler, Tyler's Herbs of Choice. Hawthorn Press, N.Y., 1999, p. 114.

2. The Tan Sheet. April 17, 2000. p.8-9.

3. Gurley et al., Am. J. Health-Syst. Pharm., 57, 963-969, 2000.

4. Lazarou el al., JAMA, 279, 1200-1205, 1998.

See also: PPA (Phenylpropanolamine)