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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.
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.
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.
Any information on this
website that refers to herbal products or other food supplements is the about
historical observations of herbs, their properties, and uses. It is not intended
to be a substitute for medical advice by licensed physicians, and has not been
submitted for review by either the Food and Drug Administration or the American
Medical Association. Supplements are food, not medicine, and neither our
information nor our products are intended to diagnose, treat, cure, or prevent
any disease, and no guarantee of results or suitability is either expressed or