Omeonet - "Ephedra - Ephedrine: what difference?" by Josef Hasslberg

Ephedra - Ephedrine: what difference?

Legislation

The FDA has announced it will issue a ban on ephedra - a herb. Ephedrine, the isolated active substance, seems to be the culprit in many of the adverse reactions that are associated with "ephedra"-containing slimming or energizing products, specially if it is combined with caffeine. The FDA knew of the dangers of this combination and had issued rules to prohibit such products. Nevertheless, they were quite freely available at any 7-Eleven and similar stores.

Now if the FDA knew that ephedrine and caffeine don't mix and if such products were quite freely available, can anyone imagine why the FDA would not have taken decisive enforcement action against these products but instead allowed the problem to continue and pushed for a ban on ephedra, the herb? It doesn't make much sense to me.

It appears that the FDA is now preparing to come after three more substances being used in the same type of product, slimming and energizing, one could almost become paranoid and suspect that there might be a concerted action to remove some highly competitive natural products from a market that promises to become big - the obesity market! Preparing the way for - you might have guessed it - some wonderful pharmaceutical drug soon to be released. Watch out for that one. Well actually, manoeuvering has already started: Obesity pill fuels £33bn merger

In a first timid step, AHPA, the American Herbal Products Association, has asked for re-consideration of the FDA's ruling, but only with regard to traditional herbal products as used by herbalists. (See update at the end of this post)

Jenny Thomson of HSI Baltimore, in her most recent newsletter, brings up some interesting points with regard to epedra, and with US health legislation in general, which are worth looking at.

Caution: Contents May Be Hot!

Health Sciences Institute e-Alert

February 3, 2004

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Dear Reader,

As hot buttons go, the ephedra controversy is a few degrees above white-hot. Or it is among HSI members anyway.

In the e-Alert "Circle the Wagons" (1/8/04) I offered some comments about the FDA's move to ban the sale of all ephedra products by early spring. And the e-mails came pouring in - some agreeing and some passionately disagreeing with HSI's take on the situation.

Reading the e-mails, I realized two things: 1) There are still some basic misconceptions about what ephedra is and why it's been singled out by the FDA, and 2) Many members want to take action to prevent the ban, but don't know how to go about it.

So it's time to open up a fresh can of Clear Thinking, and take a look at some member mail. Caution: Contents may be steaming hot!

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Helping or hurting?
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HSI members Michael and Tonya wrote to say that I was "100% right" in my assessment of the FDA ban, but a member named Diana didn't agree, stating, "I believe that the FDA is trying to help instead of hurt. I do not believe they are taking away our freedoms just making sure we live long enough to still have them."

Diana says she just recently started receiving the e-Alert, so she may have missed some of the important points about ephedra that I've covered in previous e-Alerts.

Much of the confusion about ephedra lies in the unwillingness or inability of the media to make the simple distinction between ephedra and ephedrine. In the e-Alert "Jekyll and Hyde" (1/16/03), HSI Panelist Linda Page, Ph.D., explained the difference between ephedra and ephedrine. In a nutshell: Ephedra is a broncho-dilator that herbalists value as a natural and effective alternative to asthma and allergy drugs. Ephedrine is the active constituent of ephedra.

In a 50 mg dose of ephedra (which Dr. Page describes as an "effective dose") you're getting 0.5 mg of ephedrine. But certain products that isolate and boost ephedrine (as most of the weight-loss products do) may contain as much as 20 mg of ephedrine - 40 times the amount that you get in the natural herb. As Dr. Page points out: "No wonder there are problems!"

So when you hear about athletes, for instance, who have died while taking ephedra, you can be just about certain that they weren't taking a 50 mg dose of ephedra, but a boosted ephedrine product that can be dangerous when not taken as directed. Nevertheless, ephedra is blamed for these deaths, and now this herb is about to be banned for the sins of its hyped-up cousin, which in most of the fatal cases was used recklessly.

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Extremely energizing
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An e-mail from a member named Don observes that "The consumer is in a real quagmire of 'information,' not necessarily facts." And I agree. Don adds, "Your comments on ephedra may be valid in some areas, but there are other points of view to consider. The Jan 2004 issue of Consumer
Reports has some interesting comments that are quite different than yours."

Consumer Reports! Don't get me started! I've taken Consumer Reports to task a number of times for offering health advice, which is way out of their area of expertise. When I want electric grill ratings, I go to Consumer Reports. When I want herbal supplement advice I go to... Consumer Reports? I don't think so.

Don refers to an article that describes the numerous weight-loss and energy-boosting products that contain ephedrine. And while the article recognizes that ephedra is the "natural source of the chemical ephedrine," it incorrectly identifies ephedra - not the hyped up ephedrine - as the ingredient in "performance enhancing" products that are sold at drug store chains and convenience stores nationwide. With flashy brand names emphasizing boosts of energy in the extreme, I think it's safe to say that many of these products are produced by companies that might be described as "fly by night." Not your best choice when looking for a reputable supplement.

The article explains how these products manage to combine ephedra (again, read: hyped ephedrine) and large doses of caffeine by listing aliases for caffeine, such as "kola nut," and names such as sinica to describe ephedrine. And why do they do that? Because in 1983 the FDA banned the combination of ephedrine and caffeine in over-the-counter products.

Okay then, let's think about this. In spite of the FDA ban of the ephedrine-caffeine combo, here we are more than two decades later, and you can still purchase such products easily at your local quick mart. So I think it's safe to say that the ehpedra ban will have little or no effect on the production and sale of potentially dangerous products like these that contain boosted ephedrine. The first ban didn't
stop them - why should another?

But the ban will have a huge effect on established and respected herbal manufacturers. Most of them have already stopped producing ephedra formulas for fear of being shut down. As a result, any allergy or asthma sufferer who has relied on herbal ephedra for relief will now be forced to use pharmaceuticals.

So here's what the FDA ban of ephedra will do: It will effectively prohibit the sale of something useful - ephedra - while hyped ephedrine will most likely still be out there, often in a dangerous combination with caffeine, available to any young athlete who wishes to "enhance performance." And the ban won't even touch the synthetic version of ephedrine, which will still be widely available in many sinus and cold medications such as Sudafed (taking its name from "pseudo ephedrine").

In short: The FDA ban is destructive and pointless. But Consumer Reports and other misguided do-gooders will hail it as a victory.

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The big picture
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So... What to do? A member named Steve writes: "Can't we start a petition and/or send letters somewhere to try to make an impact on the decision to ban Ephedra?"

In a word: No. When the FDA issues the rule on ephedra (expected any day now), the ban of the herb will take effect 60 days later. During that time, the ban may be challenged in court. What happens then is anyone's guess, but I don't believe that any amount of petitions or e-mails will influence a court's decision.

So while it ain't over til it's over - I think for ephedra it's just about over. But ephedra is only one skirmish. There are more to come. And FDA officials have made no secret of the fact that they would like to do away with the Dietary Supplement Health and Education Act (DSHEA), which keeps them from regulating supplements the same way they regulate drugs.

A congressional bill titled "Dietary Supplement Safety Act of 2003" (S. 722) is currently making it's way through the senate. This bill is designed to broadly expand the FDA's authority to control the dietary supplement market. If passed, the bill could seriously inhibit your freedom to make your own health care decisions.

Fortunately, another bill has been introduced that makes S. 722 unnecessary. Under this alternative bill - "DSHEA Full Implementation and Enforcement Act," (S. 1538) - the FDA would receive additional funding to ensure that DSHEA is fully carried out, as originally intended. The new bill also increases funding for dietary supplement research and consumer information through the National Institutes of Health.

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Pen to paper
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I'm no fan of regulations and I don't believe that the way to solve problems is to throw money at them. But I do believe that DSHEA provides more than enough regulation of dietary supplements. Therefore, S. 1538 offers a reasonable and responsible alternative to the completely unnecessary extremes of S. 722.

I strongly urge you to join me in taking a moment to send a brief letter or e-mail to your Senators. (You can easily find congressional street addresses and e-mail addresses at congress.org just by entering your zip code. And we've heard that snail mail gets more attention from our public servants than e-mail.)

If you don't have time to compose a letter or an e-mail, you can follow the lead of a member named Clifford, who writes: "I took your article and copied it to an email and sent it to the two Senators from California and requested that they correct this injustice concerning ephedra, in light of what acetaminophen also does when misused."

It may be too late to correct the injustice concerning ephedra, but it's not to late to save the freedoms provided under DSHEA.