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.
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.
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.
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.
NPR’s Marketplace morning featured two stories today on the launch of GSK’s over-the-counter weight loss drug alli. One of these stories featured Prescription Access Litigation director Alex Sugerman-Brozan discussing alli and why it should not be available over-the-counter. A streaming version of the story can be found here.
Today’s New York Daily News features a great article on the promise and pitfalls of GlaxoSmithKline’s over-the-counter weight loss drug, Alli, (“Don’t Swallow the Hype,” by Julian Kesner) which is due to launch on Friday.
Of course, we like the article because it makes mention of the Bitter Pill Award which PAL gave to GSK last week, the “With Allies Like this, Who Needs Enemas?” Award. But more importantly, the article makes some vital points about this drug, including the following excerpts:
“The Alli literature also repeatedly includes this mantra: ‘Alli requires eating reduced-calorie, low-fat meals and physical activity.’ Funny – isn’t that what you’re already supposed to do to lose weight?”
“Yes, that $50 bottle is just a new name and look for a drug that has already been rejected by countless doctors and patients. Going OTC is an attempt to boost profits for a lackluster drug.”
The article then lists four weight loss alternatives that cost less than alli’s $50 a month price tag — including gym memberships, dance classes, portion control bowls and personal trainers.
GlaxoSmithKline has been nothing but forthright when it comes to the side effects of its new Over-the-Counter weight loss drug, alli (which earned the “With Allies Like This, Who Needs Enemas?” Award from PAL earlier this week) – they’ve admitted that it causes loose stools, fecal urgency and flatulence with oily spotting. And how could they not? Can you imagine consumers’ reactions if they didn’t know about these side effects until they occurred?
These side effects have caused many to wonder why on earth GlaxoSmithKline is even bothering to market this drug Over-the-Counter. It likely has much to do with the potential approval of sanofi aventis’ Acomplia (chemical name rimonabant, or Zimulti, as it likely will be called in the US), a much-awaited prescription weight loss drug that is already approved in Europe but is awaiting approval here in the U.S. (In fact, an FDA advisory board will vote on this drug tomorrow). If Acomplia/Zimulti is approved, it will further cut into the sales of prescription only Xenical. alli is the half-strength over-the-counter version of Xenical, and Xenical sales have been steadily falling over the past few years, due in no small measure to the disgusting side effects.
A video distributed by GlaxoSmithKline as part of its $150 million promotion of alli describes what GSK euphemistically calls “treatment effects.” John Mack over at Pharma Marketing Blog rightly calls this Orwellian style “Newspeak.” And the video seems to suggest that these “treatment effects” are a helpful guide to knowing when you eat too much fat. Helpful guide, indeed! As GSK advises, carry a change of clothes for the first few weeks on alli! It also seems to imply that these wonderful “treatment effects” are some kind of sign that the drug is working.
This smacks of Puritanism in that one on alli who “sins” by eating too much fat will be “punished” through oily spotting and uncontrollable diarrhea. Watch the video below and judge for yourself.
Prescription Access Litigation gives latest Bitter Pill Award to GlaxoSmithKline
Drugmaker gets the ‘With Allies Like This, Who Needs Enemas?’ Award for
Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter
BOSTON, MA – Prescription Access Litigation (PAL) today announced that its latest Bitter Pill Award is being given to GlaxoSmithKline, for the impending marketing of “alli,” (pronounced AL-eye, chemical name orlistat) an Over-the-Counter weight loss drug. Alli is being launched on June 15. PAL gave GSK the ‘With Allies Like This, Who Needs Enemas?’ Award for
Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter.
Alli is an Over-the-Counter (OTC) version of a previously prescription-only drug, Xenical. PAL believes that, by aggressively marketing alli and eliminating the need for a doctor’s supervision, GSK will cause this drug to be used inappropriately and even abused. PAL is particularly concerned that the drug will be used by teenagers and people with eating disorders. Since anyone can walk into a pharmacy and buy this drug, there are no controls in place to prevent this.
Alli is the most recent example of a drug to shift from requiring a doctor’s prescription to being available to anyone who walks into a pharmacy. While there are prescription drugs with long safety records that can be used Over-the-Counter by patients appropriately without a doctor’s supervision, alli is not one of them. Rather, the switch to OTC appears geared towards increasing the sales of a drug that has minimal effectiveness, disgusting and possibly dangerous side effects and uncertain risks. Prescription sales of Xenical have been steadily declining over the past 5 years, down from $202 million in 2000 to $86.6 million in 2005, according to IMS Health. A recent Zogby/UPI poll found that 29% of Americans said they would likely try an over-the-counter weight-loss pill.
“It is extremely irresponsible for GSK to sell alli as an Over-the-Counter drug,” said Alex Sugerman-Brozan, director of Prescription Access Litigation, “Anyone – including teenagers and people with eating disorders – will be able to walk into a pharmacy and buy this drug.”
Prescription Access Litigation, a national coalition of over 130 consumer advocacy organizations that criticizes Direct-to-Consumer Advertising of prescription drugs, has given out the Bitter Pill Awards: Exposing Drug Company Manipulation of Consumers (http://www.bitterpillawards.org) since 2005. The awards are intended to call attention to particularly insidious examples of irresponsible or manipulative drug advertising.
Alli works to block the absorption of fat by the body. The additional weight loss that results is quite minimal, with two studies showing that patients who took orlistat, the active ingredient of alli, for four years, only lost 2.8% more weight than patients taking a placebo. Alli has a number of unpleasant and disgusting side effects associated with it, including diarrhea, oily spotting, oily stools, flatulence with discharge, and fecal urgency. A book being sold by GSK as a marketing tie-in, Are you Losing It?, advises people taking alli to wear dark clothing and keep a change of clothes handy until they know how the drug will affect them. The drug also blocks the absorption of fat-soluble vitamins, including Vitamins A, D, E and K, putting patients at risk of vitamin deficiencies. Finally, even the modest additional weight loss only remains as long as patients keep taking the drug.
GSK has done an extensive pre-sales marketing campaign, emphasizing the importance of a low-fat diet and exercise. Notwithstanding this campaign and slogans like “there are no miracle diets,” making alli Over-the-Counter ensures that such “recommendations” are nothing more than that – recommendations that millions of consumers are likely to ignore (as they already do) and take the drug anyway, with potentially harmful consequences.
“A slick marketing campaign about changing eating habits is no substitute for requiring the prescription and supervision of a doctor,” added Sugerman-Brozan, “This is not aspirin – it is a drug with serious and potentially dangerous side effects and risks, and shouldn’t be available Over-the-Counter.”
Drug companies have often sought to switch prescription drugs to Over-the-Counter in an effort to increase sales or compete against generic versions of the prescription version of the drug. When a drug has a long and established record of safety, has a low potential for abuse, and can be used appropriately by consumers without a doctor’s supervision, it can and should be made available Over-the-Counter. But alli, which meets none of these criteria, should not. For all these reasons, Prescription Access Litigation awards GlaxoSmith Kline it first Bitter Pill Award of 2007, the ‘With Allies Like This, Who Needs Enemas?’ Award, for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter.
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