Like the title? I stole it from Prescription Access Litigation, which recently announced that its latest Bitter Pill Award goes to GlaxoSmithKline, for the marketing of the first FDA-approved over-the-counter diet drug alli (pronounced “ally,” get it? this pill is on your side).
PAL is a national coalition of over 130 consumer advocacy organizations (including Our Bodies Ourselves) that criticizes direct-to-consumer advertising of prescription drugs. Here’s their take on alli:
Alli is an Over-the-Counter (OTC) version of a previously prescription-only drug, Xenical. PAL believes that, by aggressively marketing alli and eliminating the need for a doctor’s supervision, GSK will cause this drug to be used inappropriately and even abused. PAL is particularly concerned that the drug will be used by teenagers and people with eating disorders. Since anyone can walk into a pharmacy and buy this drug, there are no controls in place to prevent this.
Alli is the most recent example of a drug to shift from requiring a doctor’s prescription to being available to anyone who walks into a pharmacy. While there are prescription drugs with long safety records that can be used Over-the-Counter by patients appropriately without a doctor’s supervision, alli is not one of them. Rather, the switch to OTC appears geared towards increasing the sales of a drug that has minimal effectiveness, disgusting and possibly dangerous side effects and uncertain risks. Prescription sales of Xenical have been steadily declining over the past 5 years, down from $202 million in 2000 to $86.6 million in 2005, according to IMS Health. A recent Zogby/UPI poll found that 29% of Americans said they would likely try an over-the-counter weight-loss pill.
Now about those side effects and risks … the L.A. Times ran a story on Friday that portrayed the “feeding frenzy” sparked by the new drug (their headline, really). Carla Hall writes :
It works in the digestive system by blocking the absorption of about 25% of fat that is consumed.
In a theoretical 3,000 calorie-a-day diet with about 100 grams of fat, the drug would eliminate about 225 calories.
But it can also result in what the manufacturer describes as loose stools and gas with an oily discharge. “It’s probably a smart idea to wear dark pants, and bring a change of clothes with you to work,” the drug’s official website says. (The drug maker’s literature and website say side effects can be minimized with a low-fat, reduced-calorie diet.)
But the women buying alli Thursday were unfazed by the warnings.
At a San Fernando Valley Walgreens that had sold 10 boxes — with one man among the buyers — no one was asking the pharmacist about side effects. ” ‘Will it work?’ That’s the only question they’re asking,” said the store’s pharmacy manager, who spoke on condition of anonymity.
And the answer to that question is that while the manufacturer claims dieters can lose up to 50 percent more weight with the drug than with dieting alone, that’s only if the dieter maintains a low-fat, reduced-calorie diet (and keep in mind for most dieters we’re talking an additional five pounds give or take). And according to PAL, the “additional weight loss that results is quite minimal, with two studies showing that patients who took orlistat, the active ingredient of alli, for four years, only lost 2.8% more weight than patients taking a placebo.”
GlaxoSmithKline is even hoping that the nasty side effects — which get worse if fatty foods are ingested — will act as a disincentive, leading users to eat less out of fear of leaky, oily discharge.
The L.A. Times notes that while alli is intended for overweight people 18 and older, the controls are unclear:
At some stores, it could simply be picked up off the shelf and taken to a cashier for purchase. But at a Walgreens in the San Fernando Valley, the drug was being held behind the pharmacy counter, according to the pharmacy manager. As sales were rung up, “the register prompts us to check for I.D. for a birth date,” said the pharmacy manager, who added that she would not sell it to someone under 18.
What’s absolutely clear is that this drug is so far proving to be quite popular, particularly (but not surprisingly) with women, according to pharmacists interviewed by the L.A. Times.
“And they’re not fat,” said Roe Love, a pharmacist and store manager of a Walgreens in Santa Monica.