The Guardian today reported on GlaxoSmithKline’s (NYSE:GSK) over-the-counter weight loss drug alli (“A bitter pill for slimmers?“) and its possible introduction in Europe. PAL was featured in the article, and in particular the Bitter Pill Award we gave to GSK for introducing alli in the U.S., the “With Allies Like This, Who Needs Enemas? Award

The article pointed out just how minimal the results from alli are:

Indeed, research found that people who took the 120mg dose of orlistat for a year lost between two and five kilograms more than people who took a dummy treatment. And while the weight might drop off quite quickly in the beginning, the drug doesn’t work for everyone and some will lose more weight than others. Research has also shown that people tend to put the weight back on when they come off the drug. This has led critics to speculate that it is the makers’ intention for people to take Alli long-term – though there is little evidence about how well the drug works in reducing weight for periods of longer than 12 months.

“The additional weight loss people have on this drug is quite minimal and this only lasts as long as they’re on it,” says Alex Sugarman-Brozan, director of the US consumer group, Prescription Access Litigation (Pal). “This isn’t the kind of drug people are supposed to take once and then stop taking. I think GlaxoSmithKlein is hoping and anticipating that people who aren’t disgusted by the side-effects will take it on an ongoing basis.”

One main question about alli is, given people’s general apparent unwillingness to make changes in lifestyle (diet and exercise), why would they make these changes as part of the alli diet plan if they weren’t willing to make those changes due to their own merits?

But some experts suggest that it is difficult enough for people to lose weight under regulated conditions with medical guidance, and are sceptical that many people buying Alli will have the motivation to reap the full benefits. Moreover, there are limited studies looking at the long-term benefits of Alli and research suggests the optimum dose of orlistat is 120mg, three times a day. So why is GlaxoSmithKlein selling something that contains only 60mg?

The company says there is little difference in the effects of the two doses – both are effective in aiding weight loss. Kaplan disagrees. He says that orlistat was never successful when it was only available on prescription. “It’s clearly a business decision. This wasn’t an efficacy decision. If the drug was efficacious it would be a blockbuster drug at 120mg, and it’s not,” he says. “Essentially, it’s a failed prescription drug from a marketing perspective. Here’s a situation where you have a drug that wasn’t a big success-a very modest success as a prescription drug-and they’re hoping, through marketing approaches and direct-to-consumer advertising, that it can be more successful as an over-the-counter drug.”

It is this that has led Pal to award GlaxoSmithKlein one of its Bitter Pill awards, “With Allies Like This, Who Needs Enemas?”

The article goes on to discuss our concern that it will be abused by people with eating disorders. The experted cited, Dr. Kaplan at Mass. General Hospital, disagrees with that concern but seems to miss the point:

Sugarman-Brozan is concerned that people with eating disorders might abuse it – but Kaplan isn’t convinced. He says the drug isn’t effective enough to be abused. In the end, he thinks the market will decide how well Alli works.

This presumes that people with eating disorders will only abuse weight loss drugs that are “effective.” Many people with eating disorders will employ strategies that are dangerous, regardless of their effectiveness, if they merely believe that they will be effective — such as binging and purging, misusing laxatives and the like. And while the modest weight loss that an overweight person would experience with alli might be dangerous additional weight loss in, say, a person with anorexia.

Let us hope that European regulators take a more skeptical look at alli than the FDA did.