FDA Warning Ushers GSK's Alli Toward Graveyard of Failed Obesity Products

What the FDA giveth Glaxosmithkline's Alli, it can also taketh away. It was just last month that GSK launched a flight of ads for its weight loss drug boasting "Lose weight the FDA aproved way." On Monday, the FDA warned doctors and consumers they were probing a link between the drug and liver damage.

Now, before we start blaming GSK, let's first remind ourselves of the obvious: There are only 32 cases of liver damage so far, which is a tiny fraction of the thousands of patients who have tried the drug and its prescription sister, Roche's Xenical.

And the FDA is not advising healthcare professionals to change their prescribing practices with the drug (orlistat).

Caveats done, this is clearly a disaster for the franchise. Patients who were on the cusp of trying the drug now will not. Same goes for doctors considering prescribing it. And then there will be the lawsuits, and the inevitable questions, what did GSK know, when did it know it, and did it warn patients promptly?

The warning is doubly annoying for GSK because sales of Alli had enjoyed a recent advance. Last year, sales were just $131 million, according to Ad Age, dropping by more than half from the year before. It took $95.6 million in advertising to get those revenues.

But in Q2 2009, Alli sales were £82 million, and were up 12 percent in the U.S., well on course to beat 2008. That may now be all up in smoke.

And finally: If this does kill off the Alli franchise, it reminds companies and investors of the perils of pinning your hopes on obesity drugs. As BNET readers know, there's a central problem with obesity drugs: You're trying to prevent a patient's healthy body from doing what a healthy body does -- take in nutrients. Humans have multiple metabolic drivers in that process, so there's a high level of built-in redundancies that are difficult to overcome; the result you're trying to achieve is something only seen in ill-health. Thus Alli may yet join BNET Pharma's Graveyard of Failed Obesity Products.

• Previously:
• Inside GSK's CASSPER Ghostwriting Program
• "CASSPER" Was GSK's Friendly Ghostwriting Program on Paxil
• Allergan Gets on the GSK Merry-Go-Round for a Second Time
• Amgen, GSK Lobby on Healthcare as Execs Enjoy Luxury Benefits
• GSK Q2: Generics Wreak Havoc; Cost Reductions From Layoffs Spent on Advertising
• The FDA Gives GSK a New Way to Tout Alli
• GSK's Alli Shows Future for Vivus, Arena and Orexigen's Obesity Candidates