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Unless you’ve been living in outer space or under a rock lately, you’ve noticed that our country has a serious problem with obesity. We are the fattest nation on earth. A recent British government report launched front-page headlines after it declared that if present trends continue 25% of British women and 18% of British men will be obese, meaning they are at least 20% fatter than they should be.
But in the United States already 35% women and 31% men are obese. One contributing factor may be the faithful watchdogs of the Food and Drug Administration.
Make no mistake, drugs are not the answer to the national problem. For some individuals, however, they have proven quite useful, especially one called dexfenfluramine. This is where our story begins.
Dexfenfluramine is no wonder drug. Unlike the mercilessly hyped hormonal agent that you heard about in July, it doesn’t promise that you can stuff your face till kingdom come and still maintain a figure that would put Kate Moss to shame. On the other hand, dexfenfluramine works.
At the September meeting, manufacturer Interneuron Pharmaceuticals Inc. said its drug helped 40 percent of patients in a study lose up to 10 percent of their body weight, twice the amount lost with diet alone. Myriad other studies conducted over many years have shown the drug to be an effective weight-loss tool for those who really want and need it.
Other studies, however, showed that when dexfenfluramine is given in ultra-high doses to animals, it can permanently alter their brain chemicals. But the level at which it causes this damage is 10 to 20 times higher than that which humans receive.
Nevertheless, in late September, an eight-member FDA panel voted 5-3 against recommending approval of the drug for use in the United States. After some members left, those remaining voted 3-2 in favor of the drug but an FDA spokeswoman said the second vote could not be official and so a second meeting was ordered for November.
In its caution, the FDA panel refused to weigh the slight possibility of harm of the drug versus the very real harm caused by obesity. It has been linked to heart disease, cancer, arthritis, gallbladder disease, gout, and a host of other nasties that includes even blindness. The government estimates that 300,000 Americans will die prematurely from obesity this year, the second leading lifestyle-related cause of death after cigarettes.
Moreover, it’s not like rats are our only guinea pigs, so to speak. More than a million people in more than 50 other countries are already using the drug. In some European countries they’ve had access to it for a decade.
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The refusal to approve this drug is just the latest example of the overweaning paternalism that characterized the FDA for many years but has now become quite onerous under current Commissioner David Kessler. It’s not Kessler’s fault that no new anti-obesity drug has been introduced in the last 22 years into this country that’s splitting its collective seams, but it will be his fault if this amazing streak continues.
But aren’t there other drugs that can be used in the meantime? Yes, the second fiddle appears to be a combination of two drugs, phentermine and fenfluramine. These, too, have been shown to be safe and effective. Like dexfenfluramine, however, they are treatments and not cures. The weight lost with them comes back at you like a steam train the day you stop taking them. But the FDA in its wisdom only allows doctors to prescribe them for three months. In other words, as soon you get your weight down to a healthful level, as soon as you’ve glimpsed the towers of the Land of Oz, everything is taken from you.
But how about those over-the-counter pills, phenylpropanolamine hydrochloride, mercifully shortened to "PPA." They appear to burn off about half a pound a week (though this amount can easily be overwhelmed by compensatory eating of even half a cheeseburger a day) but were shown much more effective when combined with caffeine.
Indeed, caffeine itself has been shown repeatedly to speed up the metabolism and at high enough levels, especially when combined with ephedrine and small amounts of aspirin, to slowly induce weight loss — again, unless the dieter ups his or her calorie intake even slightly.
But amazingly, in 1991 the FDA placed caffeine on its list of ingredients banned from diet aids as being ineffective.
What the heck is going on here? Is the FDA staffed at the highest levels by men who are into fat women? Or women who are into fat men? Probably not.
Instead, this is probably just another example of the FDA’s obsessive paternalism and love of bureaucracy. I just happen to know about these abuses of authority and sanity because I happen to be writing a book on obesity. Were I writing a book on tennis elbow, I could probably rattle off for you how myriad examples of how the FDA impedes those seeking relief from that problem.
Judith Stern of the American Obesity Association said that if the FDA panel recommends no on dexfenfluramine, "these doctors ought to be shot." That’s a bit harsh. How about we just force feed them until their shirt buttons pop off and they start developing that list of nasties that comes with obesity. A little bit of empathy never hurt anyone.
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