In reviewing some drugs, FDA practices twisted science

April 26, 2006

Paul Campos, OpEd, Scripps Howard News Service

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. His e-mail address Paul.Campos@Colorado.edu.



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