The International Journal of Obesity recently published the results of a six-month study of herbal thermogenic supplements. If you're familiar with the medical research, you will not be surprised to learn that the study found herbal ephedra/caffeine "promoted body weight and body fat reduction and improved blood lipids without significant adverse events" (1).

"without significant adverse events"

I just thought I would repeat that for truth-deprived newbies whose only familiarity with thermogenic supplements comes from the mainstream media.

I will address this study in a future post. For now, I want to take a look at the accompanying editorial, since it was written by one of my favorite obesity scientists. Dulloo starts off by explaining why conventional obesity treatments fail and why ephedrine/caffeine is necessary:

"The bottom line is that in response to food deprivation, the drive to eat increases and the metabolism slows down, thereby counteracting the efficacy of dieting. Pharmacotherapy aimed at dampening these compensatory mechanisms is therefore an appealing adjuvant to assist dietary approaches" (2-NA).

Dulloo also pondered the discrepancy between the anecdotal adverse effects associated with thermogenic supplements and the excellent safety record in Scandinavian countries where synthetic ephedrine/caffeine is a prescription obesity drug (trade name: Letigen).

Although there is a growing body of medical literature showing herbal source ephedrine/caffeine is also safe and effective, Dulloo wonders whether the discrepancy is related to "rare hypersensitivity," the unsupervised use of thermogenics in America, or the unfortunate practice of supplement companies combining all sorts of untested ingredients in their quest to *appear* to have the best product:

"Several of these supplements include not negligible amounts of ephedrine isomers, some of which have been implicated in adverse cardiovascular effects [6], and a plethora of other ingredients ranging from magnesium and zinc chelate to be bee pollen and royal jelly" (2-NA).

The ephedrine isomers that Dulloo is talking about are phenylpropanolamine and related norephedrine isomers. Personally, I think the "danger" of these isomers has been greatly exaggerated, but the untested combinations of stimulants that are being promoted as being "better than ECA" are certainly an unnecessary wild card. As I have been saying all along, follow the obesity scientists and do not buy thermogenics that contain untested combinations of stimulants based on wild extrapolation from very little data.

You would not believe how much mail I get every time a new wild card supplement claims to be better than ephedrine/caffeine. Admittedly, the advertisements are often very compelling and scientific-sounding, but the reality is this: even if one of these concoctions looks like it might advance the state of the art, how will you know until scientists like Dulloo do the necessary research? Lots of things look good in theory, but few survive rigorous testing.

Nonetheless, it does not seem like these things alone could account for more than a small part of the discrepancy. However, when you look at the chain of events, I think you will find there is a more likely explanation for the discrepancy between the Danish safety data and the FDA's anecdotal MedWatch data.

An ugly truth that is unlikely to appear in any medical journal....

Credit for this discovery goes to Wes Siegner, an attorney with Hyman, Phelps and McNamara. At the 1999 AHPA International Ephedra Symposium, Wes "presented data showing exceptional spikes in adverse event reports filed in the days immediately following FDA press releases and media coverage of ephedra" (3) [emphasis added].

There was no big problem before the FDA started issuing scary and misleading press releases about ephedrine. Then came the flood of adverse event reports....

Do you get the picture?

Ephedrine and caffeine (or theophylline) had been used safely for decades as an over-the-counter drug for asthma, bronchitis, etc. No big deal. But then obese people and athletes started "self-medicating" with ephedra supplements that were being promoted for "unapproved" uses like weight loss, natural high energizers, etc.

The drug warrior types seized and nothing motivates the FDA to call out the swat team faster than a percieved threat to their "approval" process -- the heart of their power. So they went after some companies for making "false" claims, but thanks to the Dietary Supplement Health and Education Act, they could no longer arbitrarily ban ephedra supplements. It must be a drag not being able to play King anymore. The FDA expressed frustration at having to prove that ephedra and other supplements are dangerous before they can ban them:

"The agency is committed to taking whatever action is necessary to remove dangerous products from the market. However, under recent amendments to the Federal Food, Drug, and Cosmetic Act, the agency has to act product-by-product and the legal burden is now on the FDA to show that a marketed product is unsafe, rather than on the company to gain FDA approval by showing that the product is safe before it is marketed" (4) [emphasis added].

Apparently, "whatever action" mean't releasing scary and misleading press releases about how they *thought* ephedrine was a deadly drug. The mainstream media never challenged these dubious press releases. In fact, they started cranking out their own ratings-boosting propaganda. Thus, the FDA managed to create such a panic that people started blaming everything from birth control failures to murders on thermogenic supplements!

Then the public was assaulted with more scary press releases about the growing number of adverse events "associated" with thermogenic supplements. As one might expect, this generated even more panic and -- of course -- more adverse event reports.

Barsky AJ, et al. "Nonspecific medication side effects and the nocebo phenomenon." JAMA, 2002 Feb 6; Vol: 287; Number: 5; Page: 622-7.

"factors that appear to be associated with the nocebo phenomenon...  the patient's expectations of adverse effects at the outset of treatment; a process of conditioning in which the patient learns from prior experiences to associate medication -taking with somatic symptoms; certain psychological characteristics such as anxiety, depression, and the tendency to somatize; and situational and contextual factors." [emphasis added]

Warning: Always seek prompt medical attention if you think you are having a bad reaction. Do NOT assume that it is a nocebo effect. Even things as seemingly safe as peanuts can cause serious medical complications in some individuals. For more information, read our Terms of Service.

The power of suggestion.

In medical studies, this is why some people in the placebo group suffer weird side effects. They *think* they are getting the real drug, so a percentage of them actually experience side effects even though they are only getting a sugar pill. This type of phenomenom is called the Nocebo Effect. (Nocebo means "I will harm" in Latin; placebo means "I will please.")

The FDA, aided and abetted by the mainstream media, created the mother of all nocebo effects!

Think about it. When you first take the ECA stack, you can definitely feel the stimulative effect, and if you recently read an FDA press release saying ephedrine is a deadly drug, it's pretty darn easy to get worked up into a panic and have a rather nasty experience.

I think this is the best explanation of why the FDA's adverse event reports conflict with the medical studies that show only minor, temporary side effects. The FDA set the stage so ECA's minor side effects would be percieved as life-threatening "Maybe I should go to the emergency room" problems. The data showing "exceptional spikes in adverse event reports filed in the days immediately following FDA press releases and media coverage of ephedra" (3) supports this conclusion.

When you look at the chain of events, it is clear that the American public has been deceived and manipulated because the FDA does not like people "self-medicating" with "unapproved" supplements that compete with prescription drugs. And of course the DEA wants to get rid of ephedrine because it is used to make meth. So it's power and politics versus an "unapproved" supplement and a stigmatized disease. Even with obesity scientists speaking out about the benefits of ephedrine/caffeine, it's not much of a horse race. I am sick of living with the fear that I won't be able to buy the medicine I need.

We live in a profoundly sad time where obese people have been so beaten down by prejudice that many blame themselves for a condition that science has clearly proven to be a genetic disease. This ubiquitous prejudice causes regulators, consumer protection groups, and many health professionals to feel that diet pills -- both prescription and supplements -- are unacceptable unless they are totally safe for all people under all circumstances. Of course, nothing on the planet Earth could pass that safety test, but this fact is conveniently ignored.

Why would they do that? Well, the thinking is that we don't really NEED diet pills -- we just need to eat less and move more. There are no fat people in concentration camps, right? So they ignore any rational risk/reward analysis and tell us to play it safe and avoid diet drugs. Some go so far as to greatly exaggerate the danger and spread misinformation to discourage us from taking thermogenic supplements -- for our own good, of course.

These attitudes -- not lack of scientific knowledge -- are responsible for our inability to curtail the obesity epidemic. These poisonous attitudes are the reason why there is no public outcry about the FDA committing scientific fraud in its attempt to demonize ephedrine.

You can choose from phantom fears

Or kindness that can kill

I will choose a path that's clear

I will choose free will

-- from the song "Free Will" by Rush.

Written
Aug 2002
Last Update
Aug 2002

Dulloo closes the editorial stating that the Danish experience, where ephedrine/caffeine is a prescription obesity drug called Letigen, shows that it is "a viable and cost-effective approach to treat obesity" and he calls on the FDA to consider adopting a Danish-type system where doctors regularly prescribe ephedrine/caffeine for obesity:

"Based upon the Danish experience, the FDA might consider that the licensing under prescription of synthetic mixtures of ephedrine and caffeine could offer a viable and cost-effective approach to treat obesity and that large clinical trials with this drug combination are both necessary and ethically justified" (2-NA).

This would be much better than the current situation where doctors generally neglect to tell obese people about anything except FDA-approved prescription drugs.  Personally, I think anyone contemplating taking the ECA stack should approach it just like starting an exercise program and see a doctor for a general health screening to make sure they don't have a condition that could cause a problem. Frankly, the medical community should have taken the lead with this (and countered the propaganda with accurate information). The "unapproved" status of ephedrine-based weight loss supplements is no excuse.

There is no reason why freely available thermogenic supplements   could not coexist on the market with a prescription ephedrine/caffeine preparation like Letigen. I suspect a lot of people would be willing to pay a premium for a guaranteed-potency synthetic ephedrine/caffeine preparation.

However, I fear the FDA would use this as an excuse to ban thermogenic supplements and over-the-counter "asthma" medications that contain ephedrine. I   know all too well how hard it is to get a doctor to prescribe phentermine or Armour thyroid. Good luck finding a doctor willing to prescribe ephedrine after the FDA yanks it for allegedly being too dangerous for over-the-counter sale. So, although I would dearly love to see more doctors acknowledge and treat the thermogenic defect, I much prefer the current situation to one where ephedrine would be available only by prescription.

Laws that interfere with the ability of adults to make important personal decisions are especially harmful to people with stigmatized diseases like obesity. These laws give prejudiced individuals and institutions WAY to much power over our personal lives. We need to take this (legal) club away from them. Intrusive laws and regulations have enabled this prejudice to do so much harm that it will even affect future generations of obese people because it has hindered the development of weight loss drugs. Listen to George Bray, obesity scientist and author of hundreds of scientific papers:

"Current regulations appear to bear little relation to the realities associated with these [obesity] medications. Even worse, criminal prosecutions can be based on untruthful regulations, but the perpetrators of the regulations are not held liable for the negligence that they have produced. Moreover, current regulations inhibit future developments because they indicate a closed and unresponsive legalistic mentality on the part of regulatory authorities" (5-NA) [emphasis added].

Bureaucrats and guns should not trump scientists and test tubes.

1.) Boozer CN; Daly PA; Homel P; Solomon JL; Blanchard D; Nasser JA; Strauss R, and Meredith T. "Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial." Int J Obes Relat Metab Disord, 2002 May; Vol: 26; Number: 5; Page: 593-604; PMID: 12032741.

2-NA.) Dulloo AG. "Herbal simulation of ephedrine and caffeine in treatment of obesity." Int J Obes Relat Metab Disord, 2002 May; Vol: 26; Number: 5; Page: 590-2; PMID: 12032740.

3.) Jones, D "Highlights of the 1999 AHPA International Ephedra Symposium" Natural Products Industry Insider. [Scroll down -- near bottom of page.]

4.) FDA Statement on Street Drugs Containing Botanical Ephedrine. April 10, 1996

5-NA.) Bray GA. "Barriers to the treatment of obesity." Ann Intern Med, 1991 Jul 15; Vol: 115; Number: 2; Page: 152-3; PMID: 1760006.

6.) Moya-Huff FA; Kiritsy PJ, and Maher TJ. "Cardiovascular differences between phenylpropanolamine and its related norephedrine isomers in the rat." J Pharm Sci, 1987 Feb; Vol: 76; Number: 2; Page: 114-6; PMID: 3572747.