Bent S, Tiedt TN, Odden MC, Shlipak MG. "The relative safety of ephedra compared with other herbal products." Ann Intern Med. 2003 Mar 18;138(6):468-71.
"RESULTS: Products containing ephedra accounted for 64% of all adverse reactions to herbs in the United States, yet these products represented only 0.82% of herbal product sales. The relative risks for an adverse reaction in persons using ephedra compared with other herbs were extremely high, ranging from 100 (95% CI, 83 to 140) for kava to 720 (CI, 520 to 1100) for Ginkgo biloba."

First, the authors of this ephedra side effects "study" have a serious conflict of interest, since they testify for the scumbag lawyers that are getting rich off the FDA's anti-ephedra propaganda:

"Potential Financial Conflicts of Interest: Expert Testimony: S. Bent (Livsey vs. Metabolife; Neumann vs. Herbalife), T.N. Tiedt (cases involving Metabolife International, Cytodyne, MuscleTech, Next Nutrition, TwinLabs, Dorsey Labs, Enrich, E'Ola, GNC, Phoenix Labs, Chemins Labs), M.G. Shlipak (Livsey vs. Metabolife; McDonald vs. TwinLabs)" (1).

Of course, one should not discount a study simply because there are conflicts of interest. But this "study" used such bad methodology that its publication caused a flurry of critical letters from knowledgeable people.  Once again, we see that the anti-ephedra camp, lacking credible evidence, finds it must resort to using bogus data in their efforts to demonize ephedrine:

"We draw your attention to serious methodologic flaws and failure of peer review in Bent and colleagues' article on ephedra and adverse reactions . . . A careful reading reveals that the 64% of cases represented by the authors as authenticated adverse events reported to poison centers also includes cases coded as unrelated to the substance in question . . . rendering the results presented in Bent and colleagues' work invalid" (2).

Frankly, we could stop right here, since obviously you can't draw conclusions from data that includes adverse events that are "unrelated to the substance in question" (ephedra). But let's look at some more of the desperate measures this study took to convince soccer moms that thermogenic supplements should be banned. As Annette Dickinson, PhD of the Council for Responsible Nutrition pointed out:

"Unfortunately, the authors relied on sales data that fail to encompass the bulk of the ephedra market, and therefore their calculations of relative risk are severely flawed . . . More comprehensive data compiled by the Nutrition Business Journal indicate that in 2001, ephedra accounted for about 7.5% of total dietary supplement sales and about 33% of sales of herbal products. Using 35% rather than 0.82% as the denominator would of course drastically change the calculation of the relative risk for an adverse event" (3).

Oops, there's another fatal 'error' that completely invalidates this study. One of my favorite doctors, Julian M. Whitaker, MD provides more detail on the junk science in this study:

". . . their data were extremely inaccurate. To estimate ephedra consumption, they used marketing data from SPINS, Inc. (San Francisco, California), on ephedra consumed in the category "Herbal Formulas and Singles," which accounted for 403 976 units per year. Yet they ignored the ephedra-containing products used for weight loss or energy -- their stated concern -- categorized by SPINS as "Vitamins and Supplements." This category accounted for 12 568 641 units per year, which is 31 times the amount on which Bent and colleagues based their conclusions. This oversight grossly exaggerates the relative risks of ephedra" (4).

In addition to all these fatal statistical errors, this "study" is really comparing apples and oranges. Ephedra is a stimulant; of course it will cause minor transient problems like insomnia. Most herbs have VERY low adverse reaction rates, but if you compare ephedra to, say, Wellbutrin, then ephedra looks amazingly safe. Considering the fact that ephedrine/caffeine is the best treatment that scientists have been able to find for a disease that kills roughly 300,000 people every year, it would be more appropriate to compare the adverse reaction rates to drugs (5) that actually treat disease instead of comparing ephedra to Aunt Betty's chamomile tea.

However, perhaps the most important reason why this study isn't worth the paper it was printed on is because most of the adverse reactions are nocebo effects that are the result of a long propaganda campaign by the FDA. The FDA and the media created such a panic that people were calling MedWatch and blaming ephedrine for birth control failures, drunk driving, murders, you name it! Bogus data = worthless study:

More info on ephedra and the nocebo effect:
http://www.drumlib.com/dp/000027.htm

The FDA's propaganda campaign is based on scientific fraud:
http://www.drumlib.com/dp/000025.htm#Fraud

The FDA's use of MedWatch to collect dubious anonymous adverse reaction reports for use as weapons against dietary supplements:
http://www.drumlib.com/dp/000024.htm

Heart Attack and Stroke Rates

With thermogenic supplements, adverse event reports are often nothing more than unpleasant stimulation similar to what occurs if one consumes more coffee than one is accustomed to drinking. But throw in a good dose of panic from FDA propaganda and the unpleasant experience becomes an adverse event report. Therefore, what is needed is a better measure of the risk involved with taking thermogenic supplements. Something that is not subjective like the adverse event reports. How about data comparing the rate of heart attacks and strokes among ephedra users and the general population?

Not only do newspapers and the media refuse to report that there has never been a single serious adverse event during all the medical studies on ephedrine/caffeine, they also ignore the detailed analysis performed by Dr. Stephen Kimmel, an expert in cardiac epidemiology and Assistant Professor of Medicine and Epidemiology at the University of Pennsylvania School of Medicine, and chair of the EEC panel that found users of thermogenic supplements are no more likely to have a heart attack or a stroke than the general population:

"Expert epidemiological analysis of available data shows that the incidence of seizures, strokes, and MIs in persons consuming dietary supplements containing ephedrine alkaloids is no greater than the expected incidence in the general U.S. population . . . It is illogical for FDA to allege that dietary supplements containing ephedrine alkaloids are causing seizures, strokes, and MIs when the rates of those events among ephedra users are within the background rates for those events in the general population. Only if the rates of those events among ephedra users were higher than the background rates for those events would FDA have cause for concern" (6) [emphasis added].

"Dr. Kimmel's review of the published literature showed that the estimated rate of seizures in young adults is 20-60/100,000; of strokes, 3-60/100,000; and heart attacks, 5-41/100,000. In the aggregate, approximately 75,000 people under the age of 45 have strokes each year in the U.S., and between 22,000 and 66,000 people under the age of 40 have heart attacks. Dr. Kimmel then compared the rate of these events reported to FDA, taking care to make assumptions to overestimate risk, and found that, in all cases, reporting rates for persons using ephedra were below or within the expected range for the general population" (6) [emphasis added].

"Despite numerous requests to do so, FDA has refused to assess whether the reports it has received are consistent with background risk" (7).

As you can see, the FDA refuses to analyze the ephedra data in a fair manner -- they are only concerned with generating scary press releases to minimize the public backlash when they ban thermogenic supplements. I believe that anyone who takes an objective look at the evidence will come to the inescapable conclusion that thermogenic supplements have been unfairly demonized by the FDA.

I realize that news of dishonest politicians and bureaucrats is not likely to shock anybody, but this is a matter where they have lied, year after year in a well orchestrated propaganda campaign, about what is currently the most effective treatment for obesity -- a disease which kills an estimated 300,000 people every year.

Unfortunately, this seems to be part of a much larger trend. With a handful of tax-preference seeking corporations owning virtually all the media, it seems politicians realize they can lie about almost anything and get away with it. I fear what the future will bring if we do not find some way to hold our "public servants" accountable for the harm they cause.

Written
Nov 2003
Last Update
Nov 2003

1.) Bent S, et al. "The relative safety of ephedra compared with other herbal products." Ann Intern Med. 2003 Mar 18;138(6):468-71.

2.) Kingston RL., et al. "The Relative Safety of Ephedra Compared with Other Herbal Products" Ann Intern Med. 2003 Sep 2;139(5 Pt 1):385; PMID: 12965952.

3.) Dickinson A. "The relative safety of ephedra compared with other herbal products."
Ann Intern Med. 2003 Sep 2;139(5 Pt 1):385; PMID: 12965951.

4.) Whitaker JM. "The relative safety of ephedra compared with other herbal products."
Ann Intern Med. 2003 Sep 2;139(5 Pt 1):385; PMID: 12965950.

5.) The medical journal, JAMA, recently published a meta-analysis of adverse drug reactions (ADRs) in hospitalized patients and found that PRESCRIPTION drugs are "between the fourth and sixth leading cause of death" in the United States. This is an estimated 2.2 million serious ADRs and 106,000 deaths EACH YEAR from prescription drugs! By the way, they define "serious adverse drug reactions" as "those that required hospitalization, were permanently disabling, or resulted in death" How dare they portray supplements as dangerous?
- Lazarou J, et al. "Incidence of adverse drug reactions in hospitalized patients: a meta- analysis of prospective studies." JAMA. 1998 Apr 15; 279(15):1200-5, PMID: 0009555760.

6.) http://www.ephedrafacts.com/backgroundreport.html

7.) http://www.ephedrafacts.com/execsummary.html