Activist Judges!

Utah what a state! Judge's Decision Lifts Ban on Sale of Ephedra in Utah

Really the article does a great job of stating it all. Here are some of the gems:

A federal judge in Utah on Thursday struck down a Food and Drug Administration ban on the herbal supplement ephedra, an adrenalinelike stimulant linked to dozens of deaths.
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Bruce Hough, president of the Nutraceutical Corporation [located in Utah], which brought the suit, said that it had no immediate plans to resume the sale of ephedra, which was pulled off the market a year ago this week.

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Dr. Julian Bailes, chairman of neurosurgery at West Virginia University School of Medicine, said the ruling was "a green light to abuse this substance again."

Dr. Bailes's research established a link between ephedra - an ingredient in supplements said to aid weight loss, enhance sports performance and increase energy - and heat-stroke deaths among young athletes. Ephedra has been linked to more than 80 deaths, though estimates vary.

More adverse reactions were reported from the use of ephedra than from the use of all other herbal supplements combined, Dr. Bailes said.

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Judge Campbell stated in her ruling that the F.D.A. had failed to prove that low doses of ephedra were dangerous. In fact, she found, the agency was caught in a bind. It suspected that all doses of ephedra posed a risk, suggesting that further research would have been unethical.

Unable to determine a safe dose of ephedra, the agency banned them all.

That, however, is not legal, Judge Campbell ruled. A 1994 law championed by Senator Tom Harkin, Democrat of Iowa, and Senator Orrin G. Hatch, Republican of Utah, shields makers of herbal and nutritional supplements from strict adherence to F.D.A. rules that require drug makers to prove that their products are safe and effective.

Instead, the law defines nutritional supplements as food, which is assumed to be safe unless federal regulators can prove otherwise. After all, "if food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited," Judge Campbell wrote.

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Because the research on ephedra is incomplete, the drug agency could not prove that low doses of the supplement were unsafe. And because the burden of proof under the 1994 law is the agency's, its ban was illegal, the judge wrote.

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Safety advocates have long complained that the law governing herbal and nutritional supplements allows their manufacturers to sell potentially dangerous products with little federal oversight.

Advocates of the law say that it provides needed protection for the companies that cannot afford to undertake the enormous expense involved in underwriting the clinical trials to prove that their products are safe and effective.

Senator Edward M. Kennedy, Democrat of Massachusetts, said Thursday's ruling showed that the 1994 law needed to be changed. At the time, Mr. Kennedy tried to include a provision that would have prohibited supplements that presented a "reasonable possibility of harm."

"If F.D.A. can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so," Mr. Kennedy said through a spokeswoman.

But Mr. Hatch said that "the history of ephedra regulation has been tortured, and I do not believe it is a good example of how the government should resolve dietary supplement safety."

Yet somehow, Sen. Orin Hatch is a godsend but Sen. Ed Keneddy is a lunatic.

I just don't get it.

I am one of those people who says these supplements should be regulated just like medicines. There are many reasons to agree with this statement, the most obvious is the ephedra/death link. Supplements have also been proven to interact (sometimes dangerously) with other medications.

The judge is in disagreement with the FDA when it comes to their statement that further research would be unethical. As a scientist working in clinical research (the kind the judge would like to see furthered on the drug) I would have to say that it would INDEED be unethical to further research on ephedra. Think about it, I guess the study could titrate people Down from the dose of ephedra linked to death, to lower and lower doses until they find a dose that does not cause death in patients. However, death as an endpoint typically only applies to clinical trials involving terminally ill patients, and death is typically a quantifier. In other words, a trial using death as an endpoint attempts to prove the drug prolongs life when compared to placebo. Or alternatively, drug A allows you not to die as fast as if you just took nothing at all. Which in the case of ephedra, has already been proven. Patients who took ephedra died FASTER than people who took nothing at all.

But lets just ignore the pesky ethics of clinical research for the minute. Should this have been regulated like a pharmaceutical, the makers of ephedra would have to patent each new dosage and treat each of them as a seperate entity, performing trials first in animals, should it prove minimaly toxic, the FDA would allow further studies in humans, etc. However, all that research costs money! Money the supplement industry (largely located in Utah by the way) would rather give to Senator Orin Hatch to pass supplement friendly legislation, that would hold the FDA useless when it came to arbitrating wether or not a deadly substance is, in fact, a deadly substance.

And finally, the judge in this case compares supplements to food. The judge's statement that "if food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited" demonstrates even further her ignorance. Food producers are not required to domonstrate benefit, rather they are required to demonstrate LACK OF HARM.

Supplements are hardly treated as food items, they look like pills and you take dosages. Its not like you walk into a Bistro, look at the menu and say, hmm I think I'll have the condroitin etoufee' served with a side of hGH-PH Complex in an Alpha Lipidoic Acid reduction garnished with freshly greated snyepherine.

So I guess the 80 people who have already died, and the people who will inevitably die from Ephedra use don't count in Orin Hatch's culture of life.