January 24, 2006
When will the FDA Protect Consumers?
CNN reported today that a U.S. Food and Drug Administration (FDA) has voted to recommend that Xenical (orlistat) be sold over the counter. The prescription drug, touted as a weight loss drug, prohibits absorption of dietary fats, and instead sends them, unabsorbed, though the digestive system. You can draw your own conclusions about the side effects.
It's no doubt that the over the counter drug, to be called Alli, will be ultimately approved by the FDA, since they usually rubber stamp the recommendations of advisory committees when it comes to diet pills (remember Redux?).
According to the CNN article, the over the counter version would be about half as potent as it's prescription counterpart. Raise your hand if you think that people, desperate for a "magic pill," will take only the recommended dosage. I don't think so, either.
With a cost of $12 to $25 a week, GlaxoSmithKline stands to rake in $1.5 billion a year in retail sales of Alli. Yes, that's billion with a "b".
Let's see.... In clinical trials over a six-month timeframe, people who took the drug lost 5.3 to 6.2 pounds more than those who took a placebo (in conjunction with diet and exercise, of course). Let's give them the benefit of the doubt and say that the over the counter pill will cost $12 a week (the lowest price point) and that the average person will lose 6.2 pounds in six months (the most optimistic outcome attributable to the drug, based on clinical trials). Six months is 26 weeks, times $12. That's $312 dollars (or $625 if you go with the highest price point). Divide the number of pounds lost into $312, and that's $50.32 per pound (or $100.80 for the high price point).
So, the FDA thinks that it's wise for consumers to pay between $50 and $100 to lose one pound, even though all admit that, once someone stops taking the drug, they gain all the weight they lost.
But, again, this is the same FDA that thought Redux - which harmed or killed untold numbers of people who wanted to lose weight - was the best thing since sliced bread, despite research to the contrary.
At what point will this governmental agency, charged with protecting the American public, actually start doing its job?
Posted by conradb212 at January 24, 2006 04:17 PM