Second, the rest of this email is dedicated to the new anti ephedrine onslaught
that appears to be going on in the media. The anti ephedrine camp
seems to be making another wave of worthless emotional based statements,
which as usual, lack any real data. This tactic is of course an old one. As
the man said:
'All propaganda has to be popular and has to adapt its spiritual level to
the perception of the least intelligent of those towards whom it intends to
direct itself.' - Adolf Hitler, Mein Kamp
Most of you may have heard of a new 'study' supposedly showing how
dangerous ephedrine is and the death of baseball player Steve Belcher is
being blamed on ephedrine. Both are complete shams!
Ok, below is my lay commentary of this 'study' followed by BrinkZone members
Doug Kalman MS, Jose Antonio, Ph.D., FACSM, and Richard B. Kreider, PhD,
letter to the editor of the journal that published the study with a nice
analysis of the data of the study.
Finally, is a link to a press released from Miami Research Associates
(also written by Doug Kalmen) that looks at the death of this base ball
player the media is blaming in ephedrine.
- 'Anti Ephedrine Campaign's latest bogus study':
Well gang the anti supplement powers that be, are at it again with a new
'study' that supposedly shows the dangers of ephedrine. Typical of the
'don't confuse us with the facts' media, this study is being plastered
all over the news and held up as a reason to pull ephedrine containing
products off the market. At this point, it appears they are so desperate to
find proof that ephedrine is a health hazard, they are willing stretch the
truth to absurd levels.
What am I referring to? A new study called 'The Relative Safety of Ephedra
Compared with Other Herbal Products' published in Annals of Internal
Medicine (2003;138:000-000). This study is not bad science, it's not science
What the authors did was examine reports put into the American Association
of Poison Control Centers Toxic Event Surveillance System Database Annual
Report for 2001, and make conclusions about the safety of ephedra based on
For example, the authors state:
'Ephedra is widely used in dietary supplements that are marketed to promote
weight loss or increase energy; however, the safety of this product has
been questioned because of numerous case reports of adverse events.'
Translated: they have already decided that ephedra is unsafe and are going
to prove it no matter what they have to do. Hence, the authors were biased
(more on that in a minute) from the start and made it their job to confirm
their biased belief.
Basically what these authors did was compare the adverse reaction reports
from American Association of Poison Control Centers Toxic Event Surveillance
System vs reports on other herbs and shock of all shocks, conclude that
compared to other herbs such as ginko and kava, that ephedra has more side
Well Duh. They concluded that ephedra containing products accounted for
64% of all reported adverse effects from herbs compared with kava and Ginkgo biloba
(see letter data showing thats not even true).
'This risk was defined as the ratio of adverse reactions to ephedra versus
other products, divided by the ratio of their relative use in the United
Translated: a fancy way of saying that they compared apples to oranges
(ephedrine vs ginko or Kava) and concluded ephedrine accounted for a higher
rate of reported side effects. This is equivalent to comparing coffee (a
stimulant) to fruit juice and coming to the shocking conclusion that coffee
has more side effects than fruit juice! Now, why didn't they compare it to
say other diet products, in particular diet drugs with similar mechanisms?
You would find that pharmaceutical diet drugs are involved in considerably
more adverse events than ephedrine based products, and those events, on
average, are of a more serious nature. Let's not forget the recent study
published in the Journal of Strength and Conditioning Research, that found
an ephedrine caffeine based supplement was superior for weight loss with
less side effects than the popular diet drug Xenical (Orlistat), one of
the most commonly prescribed diet drugs in the United States.
Of course, in truth none of this info from this new report from the Poison
Control Centers can be used to represent the true risk of any drug or
nutrient as it is simply people calling into claim some product made them
It does tell public health officials if some product in particular
should be looked for un expected side effects, etc, but it's of little use
in making real decisions regarding the safety profile of any drug or
nutrient. That's what true double blind placebo controlled human studies
are for, of which there are MANY with ephedrine. What about those studies
with ephedrine? Every single study to date-with more than a decade of
research-has concluded the side effects are minor, transient, and short
The authors didn't bother to mention any of the real data that exists on
ephedrine but focused on a single study that had a high drop out rate
from the study. Of course ephedra is not without risk and there are
many people who should not use it, such as those with high blood pressure
and other contraindications, but as weight loss compounds go, it is
exceedingly safe. Safer in fact than most over the counter medications
found in stores, such as aspirin and acetaminophen.
Bottom line is, considering the billions of doses sold of ephedra containing
products and the millions of people using such products, the number of
adverse events reported is amazingly small.
The authors of this bogus study conclude:
'Ephedra use is associated with a greatly increased risk for adverse
reactions compared with other herbs, and its use should be restricted.'
Translated: they had an agenda to show ephedra was unsafe, and found a
unscientific way of showing it vs following the real data that exists or
comparing ephedra to drugs for the same purpose that are more toxic than
ephedrine. But wait, it gets better. If you recall I mentioned the authors
were clearly biased. Why? All of the authors of this so called study have
worked for various lawfirms who are involved in anti-ephedra lawsuits!
That's right, the authors of this report are paid by law firms and called
as expert witnesses in cases against companies (e.g., Cytodyne, MuscleTech,
Next Nutrition, TwinLabs, GNC, Phoenix Labs, Chemins Labs, etc.) that
produce and market supplements containing ephedra!
Yes folks, that's how low the anti ephedra camp is willing to go; to any
lengths to get ephedra banned, and the facts based on science be damned.
People that would like to read the full study can view it on line at: http://www.acponline.org/journals/annals/ephedra.htm
People that would like to view the annual poison control data to see what
crazy things are reported can see it at the Poison Control Center web site
Finally, people that want to see my opinion on the best ways to use
ephedrine based products, avoid side effects, etc, should read my book
Diet Supplements Revealed found at: http://www.aboutsupplements.com
- An Analysis of the Relative Safety of Ephedra
By Doug Kalman MS, Jose Antonio, Ph.D., FACSM, and Richard B. Kreider, PhD,
In an early Internet release, the Annals of Internal Medicine posted an
upcoming brief communication concerning the dietary supplement ephedra (1).
This study raised media frenzy concerning the regulatory status of ephedra.
The authors utilized the Toxic Exposure Surveillance System (TESS) report
of 2001 and compared it with ephedra sales data provided to them by SPINS,
a market analysis firm. In addition, the authors also utilized a magazine
report to approximate the total sales of ephedra within the United States
for the year 2000 (2). There are several methodological and fundamental
flaws with the design and conclusions made by Bent et al.
The TESS raw data indicates that 55.5% of all Poison Control Center reports
related to Ma Huang (ephedra) alone or in combination with another herb
(multi-botanical) were in people under the age of 19. Additionally, 27.9%
of all of the exposures were in children less than 6 years of age (3).
This information is vital as in 7,927 exposures; the Poison Control Centers
deemed 14% (1,178) to be an adverse reaction. In clinical research the
guidelines set forth by the International Committee on Harmonization (ICH)
defines an adverse reaction/event (AE) 'any untoward medical occurrence in
a patient or clinical investigation subject administered a pharmaceutical
product and which does not necessarily have to have a causal relationship
with this treatment' (4). The TESS system defines an adverse reaction (AR)
as 'an adverse event occurring with normal, prescribed, labeled or
recommended use of the product, as opposed to overdose, misuse or abuse'.
The TESS system also captures AR's that are 'unwanted effects due to an
allergic, hypersensitive, or idiosyncratic response to the active or
inactive ingredients, or excipients'. Thus, the definitions and
establishment of clear causality or relationship is not clear within the
TESS system and when contrasted with normal research guidelines for
defining and AE/AR appear to be questionable. The Center for Drug
Evaluation and Research (CDER) policy on AR/AE's is that accumulated case
reports (AER's) cannot be used to calculate incidence or estimates of drug
risk (5). This misguided calculation is exactly what the authors attempted
The 2001 TESS report details that the vast amount of exposures were
unintentional (85.2%). In the ephedra analysis, 46.7% of the exposures were
of the unintentional variety (using TESS definitions and data from table
22B). It cannot be downplayed that the TESS report only captured data on 12
known herbs, Drs. Bent et al mistakenly state that ephedra accounts for 64%
of all herbal related adverse reactions, however, there are hundred of
herbals sold on the U.S. market, not 12, thus their conclusion is
The sales data that Drs. Bent et al utilized in an attempt to correlate the
TESS data with sales is incomplete. The SPINS database does not capture
data by zip code nor does it capture the true mass market (i.e., Walmart,
Costco, GNC Corporate stores), thus any data generated by the SPINS agency
is only a small snapshot of what is truly happening in the sales of ephedra
or ephedra-related products. The Nutrition Business Journal estimates that
in 2000, ephedra and ephedra related products generated $1,050,000,000 (6).
Utilizing the NBJ market analysis, the best estimate is that 26,250,000
servings (or individual capsules/tablets) of ephedra or ephedra related
products were sold in 2000. The sales figures are based upon retail mass
market, mail order, practitioners, Internet sales and natural food/health
chain channels (6). In the Bent report, it is stated that an assumption was
made that ephedra related sales were one-half of all non-retail herb sales
and this accounted for 0.82% of herbal product sales.
The confliction in detail does not make sense. It appears that the SPINS
data is inaccurate when comparing it to the more comprehensive NBJ data.
Thus, this section of the Bent paper appears to be out of context and unreliable.
While we as scientists and health care providers need to know the evidence
(direct, not computed) concerning the safety of ephedra or ephedra related
products, we must not fail to use the published peer-reviewed clinical
studies as the basis for an understanding. While the clinical trials are
limited in subject size as compared to Phase III drug studies, they do give
us a basis for understanding the potential for serious adverse events and
what population is best suited for potential use of these products.
It is clear that people under the age of 19 should not take this herb; there
simply have been no studies in that age group (on the herbal ephedrine).
The TESS data states 55.5% of all exposures were from people 19 or younger.
The comparison of ephedra versus other herbs inherently inaccurate as the
TESS data only captured 12 total named herbs. Given the TESS data for
ephedra reporting an adverse reaction rate of 14% (TESS conclusion) and a
mortality rate of 0.000757% (comparison of 6 deaths versus 7,927
exposures), one would expect a better comparison to be made using this
For example with relation to kava, there was one death in 336 exposures
(0.002976%), thus we can also conclude that kava is 3.9 times as likely
to cause death as ephedra. It should also be noted that the adverse
reaction frequency was similar for Gingko biloba (13.7% vs 14%) as ephedra
and the AR for kava was much higher (17.5%). Perhaps, a less negative
conclusion would not serve the purpose of the study.
The manipulative presentation of the data shared by Bent et al viewed
alongside the fact that the authors have and still testify for plaintiff
law firms on behalf of anti-ephedra litigation, leads to speculation that
this study's intent was to establish their published paper as evidence that
ephedra is dangerous. An informed professional audience must wonder where
the truth actually lays. Whose future and benefit does this paper serve?
Douglas S. Kalman MS, RD, FACN
Miami Research Associates
6280 Sunset Drive
Miami, FL. 33143
Disclosure: Mr. Kalman has testified in cases related to ephedra on behalf
of Cytodyne Technologies, Inc.
Jose Antonio, Ph.D., FACSM
Exercise Science & Health Promotion
Florida Atlantic University
777 Glades Road
P. O. Box 3091
Boca Raton, FL 33431-0991
Richard B. Kreider, PhD, EPC, FACSM, FASEP
Professor & Chair
Exercise & Sport Nutrition Laboratory
Center for Exercise, Nutrition, and Preventive Health
Department of Health, Human Performance & Recreation
PO Box 97313
Waco, TX 76798-7313
Disclosure: Dr. Kreider has served as an expert in litigation for Metabolife.
1) Bent S, Tiedt TN, Odden MC, Shiplak MG. The relative safety of ephedra
compared with other herbal products. Ann Intern Med 2003;138:000-000. www.acponline.org/journals/annals/ephedra.htm
Accessed online February 5,
2) Richman A, Witkowski JP. 7th Annual Herb Sales Survey. Whole Foods
3) Litovitz TL, Klein-Schwartz W, Rodgers GC, Cobaugh DJ, Youniss J,
Omslauer JC, May ME, Woolf AD, Benson BE. 2001 Annual report of the
American Association of Poison Control Centers Toxic Exposure Surveillance
System. Amer J Emerg Med 2002;20(5):391-452.
4) Cohen A, Posner J. A Guide to Clinical Drug Research. 2nd edition Kluwer
Academic Publishers 2002. Pp XI, 34,-35, 154.
Accessed February 18,
6) NBJ's Supplement Business Report 2002. Penton Media, Inc. Pp 5-171-2,
Figure 5-5, Figure 5-7. Available: www.nutritionbusiness.com