Associated Press reports today “Drugmaker says 2 million starter kits of weight loss pill sold since June”.

We here at the PAL Blog have been reporting on alli’s brisk sales ever since we have GlaxoSmithKline one of our Bitter Pill Awards back in May, the “With Allies Like This, Who Needs Enemas?” Award. Our posts since then about alli can be found here.

The AP article reports that GSK “expects to sell between 5 million and 6 million kits annually, translating to at least $1.5 billion (€1.06 billion) in annual retail sales.” Drugs with more than a billion in annual sales are considered “blockbusters,” but they’re usually limited to prescription drugs. This shows the success of GlaxoSmithKline’s strategy, in marketing alli (orlistat) as an over-the-counter drug, rather than as a prescription-only drug, which it used to be. The prescription version, Xenical, had only $86.6 million in sales in 2005, according to IMS Health. Yet the drug is no different, except for the dosage. The only difference is that by making it Over-the-Counter, Glaxo has done an end run around physicians, who never considered the drug very useful, as demonstrated by its lackluster sales.

To rephrase an old saying, “No one ever went broke underestimating the American people’s desire for a quick fix.” GlaxoSmithKline certainly isn’t – notwithstanding alli’s well-publicized side effects — including leakage, oily discharge and fecal urgency. Which GSK euphemistically calls “treatment effects.” And convinces people to shell out $50-60 a month for the privilege of experiencing.

Truth is indeed stranger than fiction.

Recently, we reported that Roche Pharmaceuticals (RHHBY.PK) had lost its court challenge to Australia’s ban on Direct to Consumer Advertising of over-the-counter Xenical (alli to us in the U.S., marketed here by GlaxoSmithKline (NYSE:GSK)) (Australian Court upholds ban on Xenical advertising). Now Roche reports that it expects sales of Xenical to fall, based on its inability to advertise the drug. What’s particularly telling is the quote from the story as reported on Forbes.com:

‘We feel we have done all we can and will now be considering the viability of supporting Xenical in the future,’ said managing director of Roche Products Fred Nadjarian after the judgement was announced at the end of last month.

How important, useful or effective could a drug be that cannot survive without aggressive promotion through direct-to-consumer advertising?

To paraphrase a quotation from Dr. Marcia Angell, author of The Truth About the Drug Companies, “Truly innovative drugs do not need promotion.” If Xenical were a wonder drug, it wouldn’t have to rely on TV ads.

Here’s the full item from From AFX News Limited (via Forbes.com):

Roche sees sales of weight loss drug Xenical dropping in Australia after ad ban
09.05.07, 8:20 AM ET

ZURICH (Thomson Financial) – Roche Holdings AG expects sales of its weight loss drug Xenical to fall in Australia after a federal court there banned direct advertising to consumers on concerns the drug was being sold to people who may not need it.

‘We’ve lost the ability to advertise using the brand name, which makes it very difficult to promote, so consumers will not ask for it by name in the pharmacies,’ a Roche spokeswoman in Australia told Thomson Financial News.

The pharmaceuticals group is considering its options in the wake of the court’s decision, added the spokeswoman.

‘We feel we have done all we can and will now be considering the viability of supporting Xenical in the future,’ said managing director of Roche Products Fred Nadjarian after the judgement was announced at the end of last month.

Xenical is categorised as a Schedule 3 drug, which means it is available without a prescription, but consumers should receive counselling as to its use.

sarah.fenwick@thomson.com

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.