Anti Ephedrine Campaign's latest bogus study

by  Will Brink, author of:

Muscle Building Nutrition
http://musclebuildingnutrition.com
Muscle Gaining Diet, Training Routines by Charles Poliquin & Bodybuilding Supplement Review

Diet Supplements Revealed
http://aboutsupplements.com
Real World Fat Loss Diet & Weight Loss Supplement Review

This article is dedicated to the new anti ephedrine onslaught that appears to be going on in the media.

If you want a little background check out this link: Extract: '...already too familiar with the link between 'supplements' and the deaths of athletes, the sports world was hardly shocked by yesterday's determination that the herbal stimulant ephedrine probably contributed to the death of Baltimore Orioles pitcher Steve Bechler, a 23- year-old who died of heatstroke after a spring-training workout in Florida.

"Anti Ephedrine Campaign's latest bogus study". By Will Brink

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 at all.

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 those numbers.

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 effects.

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 that's not even true).

They state:

'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 States.'

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.

(Very Important Point....)

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 ill.

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 lived.

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.

If you would like to read the full study can view it on line at: http://www.acponline.org/journals/annals/ephedra.htm

And if you 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 at: http://www.aapcc.org/

Finally...

If you 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

If you want more of my opinions on supplements that build muscle mass you can find that information and in my latest ebook Muscle Building Nutrition here: http://musclebuildingnutrition.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 to do.

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 overstated.

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 data.

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 Suite 600 Miami, FL. 33143

Disclosure: Mr. Kalman has testified in cases related to ephedra on behalf of Cytodyne Technologies, Inc.

Jose Antonio, Ph.D., FACSM Adjunct Professor 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 Baylor University PO Box 97313 Waco, TX 76798-7313

Disclosure: Dr. Kreider has served as an expert in litigation for Metabolife.

References:

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, 2003

2) Richman A, Witkowski JP. 7th Annual Herb Sales Survey. Whole Foods Magazine. 2001:23-30.

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.

5) www.fda.gov/cder/aers/ and www.fda.gov/medwatch/articles/medcont/postrep.htm#aer Accessed February 18, 2003.

6) NBJ's Supplement Business Report 2002. Penton Media, Inc. Pp 5-171-2, Figure 5-5, Figure 5-7. Available: www.nutritionbusiness.com

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- Was Steve Belcher’s Untimely Death Avoidable?

The 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. http://www.brinkzone.com/Press_Release_Ephedra_in_Spor_1.pdf

About the Author - William D. Brink
 
Will Brink is a columnist, contributing consultant, and writer for various health/fitness, medical, and bodybuilding publications. His articles relating to nutrition, supplements, weight loss, exercise and medicine can be found in such publications as Lets Live, Muscle Media 2000, MuscleMag International, The Life Extension Magazine, Muscle n Fitness, Inside Karate, Exercise For Men Only, Body International, Power, Oxygen, Penthouse, Women’s World and The Townsend Letter For Doctors.

He is the author of Priming The Anabolic Environment and Weight Loss Nutrients Revealed. He is the Consulting Sports Nutrition Editor and a monthly columnist for Physical magazine and an Editor at Large for Power magazine. Will graduated from Harvard University with a concentration in the natural sciences, and is a consultant to major supplement, dairy, and pharmaceutical companies.

He has been co author of several studies relating to sports nutrition and health found in peer reviewed academic journals, as well as having commentary published in JAMA. He runs the highly popular web site BrinkZone.com which is strategically positioned to fulfill the needs and interests of people with diverse backgrounds and knowledge.

The BrinkZone site has a following with many sports nutrition enthusiasts, athletes, fitness professionals, scientists, medical doctors, nutritionists, and interested lay people. William has been invited to lecture on the benefits of weight training and nutrition at conventions and symposiums around the U.S. and Canada, and has appeared on numerous radio and television programs.

William has also worked with athletes ranging from professional bodybuilders, golfers, fitness contestants, to police and military personnel.