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.

Back in May, PAL awarded one of our coveted Bitter Pill Awards to GlaxoSmithKline (NYSE:GSK), for its marketing of alli, an Over-the-Counter version of Xenical, a prescription weight loss drug. In our ‘With Allies Like This, Who Needs Enemas?’ Award, we called attention in particular to the risk that making this drug available Over-the-Counter would result in its being used by people for whom it was not appropriate or even dangerous, particularly children and teenagers.

Australia wisely banned Roche Pharmaceuticals from advertising Xenical directly to consumers. (GlaxoSmithKline distributes the Over-the-Counter version of Xenical in the U.S. under a licensing agreement with Roche), particularly after Roche ran an ad during Australian Idol, a show that particularly attracts a teenage audience. Roche challenged the ban in Australian Federal Court. The Age reported on August 30, 2007 that the Court has upheld the ban.

As The Age reported, Roche had made this rather laughable argument in its court filings:

Roche challenged the advertising ban in the Federal Court, arguing members of the National Drugs and Poisons Scheduling Committee had acted against the interests of public health.

In Australia, the drug is available without a prescription, but only “Behind the Counter.” This means that a customer must specifically request it from the pharmacist, who “are legally required to measure customers body mass index and age before supplying the drug.” Even with this requirement, the Australian consumer group Choice sent a young woman with a healthy weight into a sampling of drug stores to request Xenical, and found that 24 out of 30 pharmacies dispensed it to her inappropriately.

In the U.S., the drug is only approved for use by people who are both over 18 and overweight, but there are not requirements in place to prevent pharmacies from selling it to people who are younger, or who are not overweight.

GlaxoSmithKline (NYSE:GSK) released its second quarter earnings statement on July 25, 2007. They reported that sales of over-the-counter alli hit $155 million since the drug’s launch of June 14. This means that sales of alli have already exceeeded the $150 million that GSK spent on its huge promotional campaign for the drug.

Readers of this blog know that we here at Prescription Access Litigation gave one of our coveted Bitter Pill Awards to GSK for the marketing of alli: The “With Allies Like This, Who Needs Enemas?” Award. We criticized GSK for irresponsibly marketing alli as an over-the-counter drug, removing the supervision of a physician from what used to be a prescription-only drug (known as Xenical), creating the risk that the drug will be used inappropriately and even abused, particularly by teenagers and people with eating disorders.

These earnings reports once again demonstrate that aggressive drug marketing can drive significant sales. Alli is perhaps one of the best examples of that — who would have thought that a drug that causes diarrhea, oily spotting, oily stools, flatulence with discharge, and fecal urgency could be a success? The presentation that GSK released on the earnings report states that alli had “Over 2.4 billion media impressions since approval – eclipsing recent OTC launches” and that the alli website has received 4.5 million visits with an average visit time of around 10 minutes.

Time will tell whether GSK’s sales will continue upward. No doubt there was a rush of people trying the drug because of the hype surrounding its launch, and it’s likely that side effects and disappointing results (which GSK has the gall to refer to as “treatment effects”) will discourage a good number of those who tried it from continuing. But GSK has already recouped its marketing costs, so any additional sales at this point are pure profit.

The danger is that the success of alli will encourage other drug companies to try to convert prescription-only drugs to over-the-counter status. As we said in a recent Ask Pharmie column,

For many, if not most, of the OTC drugs that are at your local pharmacy, there is no problem with them being available without a prescription: their risks or side effects are low, how to use them is clear, they treat things that patients can easily recognize, they give the consumer greater choices, etc.

But not every drug should be “self-prescribed” nor should every condition be “self-medicated.” Many diseases and conditions require a physician to diagnose them in the first place, and then to monitor them and select the right medication. For many complicated diseases, a doctor needs to occasionally change the dosage of a drug or even what drug is given, and to monitor for side effects or complications. Conditions like high cholesterol, diabetes, high blood pressure and asthma are not good candidates for making the drugs to treat them available Over-the-Counter.

Several years ago, the FDA rejected an application to make a prescription-only statin for high cholesterol available over the counter. But the approval of alli raises the question of whether the FDA will be more lenient in reviewing these applications. So-called “Rx-to-OTC switches” have long been part of the strategy used to preserve sales when brand-name drugs lose their patents (such as with Claritin and Prilosec). Hopefully in the wake of recent drug safety scandals, the FDA will be more stringent in its review of these requests. But the approval of alli doesn’t bode well for that.