Jumaat, 4 Mac 2011

Drug Money and The Old Boy Network


The Melatonin Secret was out. In popular magazines and television reports, people across the country discovered that a rela¬tively small dose of this inexpensive hormone was not only a safe sleeping potion, but it also held a significant promise for extending our youth. Food-supplement manufacturers could barely keep up with the sudden demand. And making the situation even more fortuitous for the consumer, Congress had recently enacted the new Dietary Supplement Health and Education Act (DSHEA), making a hormone supplement like melatonin readily available without the delay of additional and expensive, time-consuming, product efficacy tests.
The Melatonin Secret was out. In popular magazines and television reports, people across the country discovered that a rela­tively small dose of this inexpensive hormone was not only a safe sleeping potion, but it also held a significant promise for extending our youth. Food-supplement manufacturers could barely keep up with the sudden demand. And making the situation even more fortuitous for the consumer, Congress had recently enacted the new Dietary Supplement Health and Education Act (DSHEA), making a hormone supplement like melatonin readily available without the delay of additional and expensive, time-consuming, product effi­cacy tests.

And then, on network television, along came a prominent biochemist/physician from a prestigious university with a terrifying melatonin scenario.

“I’m really scared that someone’s going to take chronic doses of melatonin for a long time and have all kinds of disturbances in their other biological rhythms, which might lead them to drive into a telephone pole,” this good doctor said.

Following up, the NBC correspondent said, “Another fear is that melatonin is sold not as a drug, but as a food supplement like vitamins. A law recently passed by Congress restricts the Food and Drug Administration’s ability to regulate food supplements. While there have been no reports of adverse reactions from melatonin, six years ago a manufacturer accidentally contaminated another food supplement used for sleep, called tryptophan, with an unknown toxin. Forty-five people were killed, and hundreds were disabled in this country alone.” Terrifying indeed.

However, one small detail was omitted from this public-interest report: At the time of this broadcast, the diligent university professor (who shall remain nameless) had already obtained a patent for a compound containing melatonin as a prescription sleeping pill, and was in the process of seeking FDA approval to market his version of melatonin through his pharmaceutical company. In other words, if this professor-cum-businessman could get the FDA to classify mel­atonin as a drug instead of the natural nutritional supplement it was currently deemed, he would be able to corner the market in the entire United States for melatonin-containing sleeping potions—or at the very least, eliminate pure melatonin in the health food store as a competitor for it.


You are probably thinking that the FDA, being an independent federal agency, would not be caught dead granting this professor the status he was seeking for melatonin. I mean, it might have the appearance of something that sounds dangerously like price gouging.

“Don’t bet against it,” says an individual who is a watchdog of FDA operations. “You’d be surprised just how cozy the FDA is with pharmaceutical companies. It’s one of the all-time ‘old boy net­works.’ When policy makers leave the FDA, they usually turn up in executive positions at the very pharmaceutical companies which produce the drugs they have recently approved.”


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