Battle over Ephedra Rages On

By Christian Probasco, Unfiltered 9-13-06

From the back of a bottle of ephedra:

Warning: Ephedra contains naturally occurring ephedrine. Do not take if you are pregnant or nursing, if you have heart disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement or seizure disorder….Stop use and call a health care professional immediately if dizziness, severe headache, rapid and/or irregular heart beat, chest pain, shortness of breath, nausea, tremor, nervousness, loss of appetite, sleeplessness, noticeable changes in behavior or loss of consciousness occur.

And so on. Sounds terrible, doesn’t it? Ephedra may have been a contributing factor in the death of twenty-three year old Baltimore Orioles pitcher Steve Bechler. It may have caused dozens of deaths since somebody started taking notes back in 1997. At the same time, users have reported over nineteen thousand ‘adverse effects’ similar to those described above.

Why would anybody take a supplement that may have killed dozens of people? Ask yourself instead why anybody would ingest a pill from a class of drugs that has killed between 3500 and 16,500 people each year. That’s how many people non-steroidal anti-inflammatory drugs and aspirin kill just through gastrointestinal bleeding. That figure doesn’t include deaths from liver toxicity or allergic reactions. If we accept the lower estimate, that’s 31,500 dead since 1997. But the Food and Drug Administration has always given aspirin and NSAIDs a pass. It has also given its stamp of approval to ephedrine, the active ingredient of ephedra. You can buy ephedrine or its less potent cousin pseudo-ephedrine at any drug store.

The FDA regulates ephedrine but thanks to the Dietary Supplement and Health and Education Act, authored by Utah’s Senator Orrin Hatch and former New Mexico Congressman Bill Richardson, it’s supposed to keep its long, bony fingers off supplements like ephedra. So what gives? A media firestorm, that’s what. Ephedra was big news when Bechler died and with some diligent research, news outlets found other cases of deaths which may have been related to ephedra. Millions of Americans took the supplement without any ill-effects, just as millions now take aspirin without severe side-effects, but a few may have died while on ephedra.

Supplement manufacturers abandoned ephedra in droves. And the big pharmaceuticals which sell ephedrine continued to contribute to politicians’ campaigns and they put pressure on the FDA. Ever eager to regulate something they should keep their mitts off, the FDA banned it in April of 2004.

Nutraceutical Corporation of Park City, Utah, and its subsidiary Solaray appealed the ban on the grounds that ephedra had been used by the Chinese for a few thousand years in the form of the herb ma huang and there still appear to be over a billion of them and that the ban shifted the burden of proving ephedra was safe/unsafe from the government to the supplement manufacturers. They won over U.S. District Court Judge Tena Campbell, no conservative, who put the kibosh on the ban in April of 2005. You can read her ruling at http://www.nutraceutical.com/courtruling.pdf.

But the empire struck back on August 17th and a three judge panel from the 10th Court of Appeals in Denver reversed Campbell’s ruling. (http://www.kscourts.org/CA10/cases/2006/08/05-4151.rtf) Now Nutraceuticals is planning to appeal to the entire 10th Court. Says their attorney, Jonathan Emord:

The 10th Circuit decision violates the plain and intended meaning of the dietary supplement adulteration provision. Congress never intended FDA to use a drug adulteration standard to evaluate the marketability of dietary supplements. Congress also clearly intended that the law of adulteration not be changed and that dietary supplements be treated like foods. Under the food standard a dietary supplement is deemed lawful unless the government meets the burden of establishing the supplement unsafe and then only at dose levels proven unsafe may it be banned from the market. FDA takes the view that if it shows some evidence of a lack of safety at some dose level, it may ban dietary supplements at every dose level. That is a power grab. It violates the rule of law, and it places all dietary supplements in jeopardy, marketable only at the whim of the FDA. We will do all we can to reverse this decision on behalf of our clients.

Reversing the decision, of course, will take months or years. In the meantime, we will continue to fork over money to bloated pharmaceutical mega-corporations for essentially the same stuff. Which raises the question, what’s stopping supplement manufacturers from buying politicians who can pressure the FDA to back off? Isn’t that the American way?

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