The Diarrhea Diet

Since GlaxoSmithKline's (GSK) high profile launch of alli last summer, the first FDA-approved diet drug sold over the counter, the only figures that have flattened are sales.

Two million starter packages sold in the first few weeks at $49.99 for 60 pills and $69.99 for 120, thanks to a $150 million populist rollout that included displays in Targets, Wal-Marts and warehouse clubs.

But in 2008 that revenue growth "will be down a notch," Jean-Pierre Garnier, GSK's outgoing CEO, cautioned financial analysts, "because you won't have as much growth coming out of alli, although we have some."

Of course all diet products generate dropouts who don't like the results they're getting or the dietary restrictions.

And GSK admits alli results are slow and close to placebo.

But not all diet products feature the "oily bowels" and "anal leakage" that made alli an instant success on the comic circuit.

Because the active ingredient in alli, Orlistat, blocks the body's absorption of fat and ushers it out the bowels, sometimes before a person is ready or warned, GSK originally cautioned users to bring backup underwear with them or wear dark colors.

Users could even exchange "accident support group" tips on alli's online message board.

"You lost a couple of pounds, and you're on a date with that special girl," riffed Jay Leno, and then find yourself saying, "Excuse me while I change my pants."

"With Allies Like This, Who Needs Enemas?" asked Prescription Access Litigation.

"Maybe it should come with a coupon for Depends," quipped Philadelphia-area pharmacist Maria Taylor.

"The Diarrhea Diet" and "Sh-t Yourself Thin" spoofed bloggers.

GSK said the dreaded "treatment effects" which occur when users exceed 15 grams of fat a day -- a fast-food hamburger has 30 -- could teach people to avoid fatty foods through aversion therapy, like Antabuse does with alcohol. (One specialist even suggested users shouldn't get so upset about a little bowel incontinence.)

But critics said if eating right is doing the heavy lifting, why do you need alli to begin with?

And Dr. Sidney M. Wolfe, director of Public Citizen's Heath Research Group, observed that "alli doesn't block carbohydrates," which for many overweight people is the real problem.

Even though Orlistat has been available as the prescription drug Xenical, manufactured by Roche since 1998, not everyone thinks it's safe.

Roche's own study raises questions about precancerous colon polyps, says Public Citizen. And questions about a higher incidence of breast cancer in early clinical trials actually delayed FDA review of the drug.

Nor has Orlistat been successful -- falling in sales from $135 million in 2002 to just $93 million in 2007, which some say led to GSK's last ditch recasting of it as an over-the-counter medication.

Of course it's no secret that GSK is hurting.

Since the New England Journal of Medicine outed its top-selling diabetes drug, Avandia, in 2007 for raising the risk of heart attack by 43 percent, and the FDA subsequently mandated a black box warning, the drug giant has lost $1 billion -- not to mention its reputation and Wall Street luster.

"When you lose the most profitable of your line, it has a disproportionate effect on the cost of goods and the gross margin," conceded Garnier to reporters reviewing last year's bleak performance.

GSK no doubt thought it could churn alli -- maybe the lower case "a" was to disassociate it with Avandia -- like a bad movie or IPO. After all, even Merck's Vioxx made money after the lawsuits were paid.

But you can't blame GSK for the public's willingness to accept anal leakage and an eating disorder as the price of being thin.

"Don't we consider people that are using drugs to induce diarrhea as suffering from bulimia, and in need of medical and psychological help?" asks a blogger writing about alli. "Maybe someone should consider repackaging Ipecac into pill form and marketing it as the newest diet plan."