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Monday, July 31, 2006

FDA Hard At Work

"During the Middle Ages there were all kinds of crazy ideas, such as that a piece of of rhinoceros horn would increase potency. Then a method was discovered for separating the ideas--which was to try one to see if it worked, and if it didn't work, to eliminate it. This method became organized, of course, into science. And it developed very well, so that we are now in the scientific age. It is such a scientific age, in fact, that we have difficulty in understanding how witch doctors could ever have existed, when nothing that they proposed ever really worked--or very little of it did. "

That's the first paragraph in Richard Feynmans Cargo Cult Science. He started off real simple. Some things don't work. Why did people think they did? That's a good question. Science is simple if you look at it that way. Yet not everyone looks at science that way. Let's see how the FDA regards this new thing called science.

Pseudoephedrine, the active ingredient in Sudafed, is also the main ingredient in methampetamine. It's a big problem. New regulations will be pulling the drug off the shelves soon. To combat a loss in revenue the scientists at Pfizer developed Sudafed PE. The active ingredient is phenylephrine.


In a peer-reviewed letter released this week to the editor of the Journal of Allergy and Clinical Immunology, University of Florida researchers argued that there's little evidence to suggest that the active ingredient in the new Sudafed PE or similar medications will do anything to relieve a stuffy nose.

In their letter, Hendeles and colleague Dr. Randy Hatton contended that when the U.S. Food and Drug Administration approved the use of phenylephrine in 1976, the agency was only able to find four studies that suggested it worked at a dose of 10 milligrams, the size of Sudafed PE pills. Two of those studies were sponsored by drug companies, and all were unpublished and not reviewed by peers, Hendeles said.
Seven other studies, according to the authors, found that phenylephrine didn't work better than a placebo.
"It does nothing," Hendeles said. "Clearly the 10 milligram (dose) does not work."

So what is happening here? We're not living in the middle ages. We're not being sold snake oil from a stage coach. It's 2006. The FDA has examined the evidence on our behalf and approved a drug that does not work. Four studies suggested that it worked, 2 of which were funded by the industry. Seven others said that it did nothing. The FDA however has accepted only the positive results. They had the same opportunity as the scientists at the University of Florida but they came up with a different conclusion.

The science that has escaped the cargo culture has lifted us up as though the entire society were enlightened invidivuals. My question is how far from the truth that is. How many are enlightened and how many would burn a witch if they were presented with "the proper evidence"? How many in the latter group work at the FDA?

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