Pubdate: Thu, 27 Apr 2006
Source: Ventura County Star (CA)
Copyright: 2006 The E.W. Scripps Co.
Contact:  http://www.staronline.com/
Details: http://www.mapinc.org/media/479
Author: Paul C. Campos
Bookmark: http://www.mapinc.org/mmj.htm (Cannabis - Medicinal)
Bookmark: http://www.mapinc.org/topics/Food+and+Drug+Administration (FDA)

IN REVIEWING SOME DRUGS, FDA PRACTICES TWISTED SCIENCE

This is the story of two drugs. The first, dexfenfluramine, was the 
active ingredient in the weight loss drug Redux. Although it was 
available in the United States and Canada for only about 18 months, 
it killed hundreds of people, and severely injured thousands more.

The second is marijuana. Over the past several decades, tens of 
millions of people across North America have used this drug 
regularly. It has, as far as anybody knows, killed no one.

Anyone interested in the politics of science should study the Food 
and Drug Agency's treatment of these two drugs. Redux was originally 
rejected for approval because of laboratory studies suggesting it 
would cause primary pulmonary hypertension - a particularly gruesome 
and generally fatal disease - in a small number of users.

The FDA panel reviewing the drug considered it too dangerous, given 
that Redux produced an average of only 7 pounds of weight loss when 
compared to a placebo. This seemed eminently sensible: after all, who 
could argue that a drug producing so little weight loss was anything 
other than a cosmetic product? And surely the FDA wouldn't approve a 
brand of lipstick on the grounds that it was likely to cause just a 
small percentage of its users to suffer horribly painful deaths.

Yet, it turned out that a whole bunch of very well-paid obesity 
researchers were willing to argue for Redux's approval. Under 
enormous pressure from the pharmaceutical industry and its academic 
hirelings, the FDA reversed course in the spring of 1996, and 
approved the drug for sale.

The results were predictable: reports of primary pulmonary 
hypertension associated with use of the drug began appearing in the 
medical literature. In addition, some users were suffering heart 
valve damage and needed major surgery. Redux was quickly pulled from 
the market, but the damage had been done.

Over the last eight years, hundreds of cases of primary pulmonary 
hypertension have been linked to Redux, while more than 1,200 of the 
drug's users have undergone major surgery for heart valve damage. 
Wyeth, the drug's maker, has paid out billions of dollars in damages, 
and faces possible bankruptcy as more claims are settled and go to trial.

Meanwhile, the FDA has just announced that it will continue to treat 
marijuana as a Schedule I drug. Drugs are supposed to be placed in 
this category only if they have a high potential for abuse and no 
medical value.

Bruce Mirken of the Marijuana Policy Project points out that, under 
current federal law, doctors are free to treat their patients with 
cocaine, methamphetamine and morphine. All these drugs are far more 
dangerous than marijuana - a drug that 11 states now allow doctors to 
prescribe to patients they believe may benefit from it.

"I have friends who are alive today because of medical marijuana," 
Mirken told me. "These are people who suffered unbearable nausea from 
chemotherapy or retroviral drugs - nausea that only marijuana was 
able to bring under control."

I asked Mirken about the FDA's statement. "The bottom line is that 
this is another sign that science at the FDA has given way to 
politics. They just pretend research evidence for the medical value 
of marijuana doesn't exist. But, in fact, quite a bit does - even 
though the federal government has done everything it can to keep this 
research from being conducted."

"They're terribly afraid of such research because any serious 
scientific study of the subject is going to reveal how little basis 
there is for their claims. Continuing to demonize marijuana is the 
key to the drug war, and the drug war pays the salaries of a lot of people."

The same thing, of course, could be said about the war on "obesity."

- - Paul Campos is a law professor at the University of Colorado.
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MAP posted-by: Jay Bergstrom