Following the withdrawal last week of a leading weight loss drug, the battle between natural approaches to weight loss and the drug companies is likely to intensify.
We first reported in April 2008 that drug giant GlaxoSmithKlein joined with some partners in filing a so-called Citizen Petition with the FDA. The petition asked the FDA to stop supplement producers from making any weight loss claims at all.
The idea was that weight is closely related to diseases such as diabetes. Therefore only FDA-approved drugs should be able to make weight loss claims.
It was clear why Glaxo thought this a good idea. If the FDA agrees, supplement competition for weight loss drugs would be wiped out in one stroke. It might be less clear at first glance why the American Dietetic Association, the Obesity Society, and Shaping America’s Health (founded by the American Diabetes Association) joined Glaxo. But then again, if you look at who is giving these organizations money, their disgraceful behavior is more understandable.
In the wake of the withdrawal last week of Abbott Labs’ Meridia pill from the market, the only weight loss drug still on the market is Glaxo’s over-the-counter drug Alli. So if the FDA finally decides to respond favorably to the petition and has natural weight loss supplements removed, Glaxo will have a total monopoly in weight loss.
Glaxo’s Alli (also known as Orlistat) is not however anybody’s idea of the perfect drug. First it doesn’t reduce weight much. Then there are the side effects.
Oily stools and flatulence are offputting enough (Glaxo even suggested that first-time users of Alli wear dark pants or bring a change of clothes to work until they get used to the diet pill’s unpleasant consequences!). Of greater health concern is the vitamin deficiency it causes. Moreover, it is now being investigated for causing liver damage—this, after going through the FDA’s drug approval process!
As the Los Angeles Times pointed out recently, this is not shaping up to be a good year for weight loss drugs. An FDA advisory committee voted against recommending approval of the drug lorcaserin—the third negative vote on prescription obesity drugs this year by the advisory committee. Lorcaserin is similar to Meridia; it works by suppressing appetite. In September, the FDA ruled that Meridia should either be taken off the market or undergo changes to limit its availability to only people who have no history or risk of cardiovascular disease. Previous studies show the drug increases the risk of heart attack and stroke among users who have cardiovascular disease. So it did not come as a surprise when Abbot Labs withdrew the drug from the US market last week. It had already been taken off the market in Europe.
An Action Alert
Just because the FDA hasn’t ruled on the Glaxo petition in over two years doesn’t mean it’s a non-issue. Far from it. The FDA often waits for years before responding. We need to remind the FDA that we’ve still got our eyes on Glaxo’s underhanded attempt to foist even more pharmaceutical monopoly on us. Please keep the pressure on. Tell the FDA you will not allow pharmaceutical companies to use the Citizen Petition process for their own financial gain. Take action now
TO SEND YOUR MESSAGE TO THE FDA Click this link to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter. |