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Another FDA fumble in the making

Big Pharma has found a new opportunity to exploit a problem and reap the big bucks, and there’s no telling where it will end. I’m talking about the overweight epidemic in this country.

And I don’t want to sound like a curmudgeon, but there really is one particular eyesore on the canvas of this country: The FDA. They’re tasked with vigilance over drug and product safety—first and foremost. Instead, they’re shoved so far down into the pockets of Big Pharma, it’s a wonder they can still breathe.

Anyone remember Vioxx? The FDA’s buddy, Merck, who created Vioxx, were just told by a jury that they’ll need to shell out $20 million to one of their hapless victims. Thank God, Merck had enough sense to pull it from the market even if the FDA was telling them that they didn’t need to. Stay tuned—there’ll be more coming on that.

And just last month, the FDA approved a new magic bullet—a weight-loss pill that now can be sold over the counter. You have to wonder: If they were so effective, why do we now have an obesity epidemic? But that kind of logic doesn’t fit well when there’s money to be made.

That logic must have escaped the geniuses at the FDA too because this is the first time the FDA has approved a weight-loss drug that doesn’t need a prescription! I guess they think that we just don’t have easy enough access to these drugs.

The pill in question is Orlistat—to be marketed as “Alli”—and is currently available only by prescription as Xenical. What’s alarming are some of the qualifiers attached to this product’s release onto the over-the-counter market. The company that produces Orlistat says that people should only use it for six months at a time. That’s as a prescription. But if it’s available over-the-counter, who is going to follow-up to make sure people stick with the six month rule? Without the guidance of a medical practitioner, you will have people out there who are basically self-treating and self-medicating with a product that initially required a prescription.

And, Orlistat is not for people under 18. Ahh, I get the picture: We’ll leave it up to the drug store clerks to check Id’s for over-the-counter medications! It’s ludicrous to think that people under 18 won’t find a way to get hold of it. On top of that, so many people have distorted body images; I’m wondering how closely people will be reading the label.

Which do you think people will be more concerned about: Whether or not this medication is good for their health, or whether or not they can drop pounds quickly? I’m inclined to think that if an easy-answer pill is what they’re reaching for, they’ve already sidestepped issues of health. And get this—the drug doesn’t work that great anyway! Just an average of three percent body weight lost after a year. Let’s say you weigh 250 pounds and need to lose 50 of those pounds. Orlistat will knock off a scant seven and a half pounds! Big deal. If you’re not overweight, the pill is not for you. That would seem like common sense, but it goes back to distorted body image. There’s a sliding scale of understanding what “overweight” actually is. I’ll be looking at this a little more closely in the May issue of my newsletter, Health Revelations.

Let’s not leave out the nagging little fact that as soon as you stop taking Orlistat, the weight creeps back on. Which makes it as ineffective as any other weight loss pill. It just doesn’t get to the down and dirty of weight loss: Healthier food selections, smaller portions, and exercise. Of course, these recommendations are never glamorous—but they work!

What about the side effects? Xenical has already been shown to lead to an increased risk of colon cancer. So, here you have a drug that is about to become an over-the-counter “remedy” for obesity, but it won’t be monitored, it won’t provide a long-term benefit, and it may increase your risk of colon cancer.

It would lead you to ask what the FDA could possibly be thinking by allowing this drug onto the market. Well, we’re all adults here and know exactly why. The obesity epidemic is firmly entrenched, and there are many who are going to work diligently to bang a profit out of the struggles and health concerns of millions out there. With millions of potential customers, the FDA and drug companies can’t see past the dollar signs.

I recommend you steer clear. A temporary weight loss just isn’t worth the health risks. The whole point of losing weight is to improve health. There are health risks associated with yo-yo dieting—which is what it appears Orlistat (to be marketed as “Alli”) will promote. If you can only take it six months at a time, and you don’t relearn your habits in that timeframe, back will come the weight when you stop taking the pills. It’ll be a rollercoaster of gain-and-drop.

Let’s have a return to common sense and stop buying into the charlatans that the FDA proudly escorts on its arm.

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