Consumer Reports, long a critic of drug advertising, recently introduced a new feature on its website: AdWatch. In the first episode, an Associate Editor picks apart the claims made in an ad for GlaxoSmithKline’s (NYSE:GSK) drug, Requip. The ad pitches Requip as a treatment for “Restless Legs Syndrome,” or RLS. RLS, while a real condition, has been massively overhyped by ads for drugs such as Requip. (For an excellent discussion of this, see “Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick” in the free journal Public Library of Science – Medicine) Requip is a drug that was originally used for Parkinson’s Disease.

Here’s Consumer Report’s very clever and thorough deconstruction of the ad:

John Mack reports on the Pharmaceutical Marketing Blog that this critique angered folks at the Restless Legs Syndrome Foundation. Guess who’s a major sponsor of this alleged consumer group? Why, GlaxoSmithKline, of course, the maker of Requip! Here’s what John Mack wrote about this today:

However, CR does have a HUGE readership that I can only dream of! As a result, its attack on Requip drew the attention of the Restless Leg Syndrome Foundation, the supposedly grassroots patient advocacy group with suspicious monetary and corporate ties to GlaxoSmithKline (GSK), the marketer of Requip (see posts cited above).

The RLS Foundation issued this clarion call to its “members”:

“We wanted to apprise everyone on our mailing list of some bad press for RLS. We want to encourage you to ‘fight back’.

“A video on consumerreports.org promises ‘relief from restless legs hype.’ The RLS Foundation is taking a tough stand against this type of bad press for RLS.

“Click here to watch this extremely sarcastic and insulting video for yourself. Then, click here to read the RLS Foundation’s response to this video.

“The RLS Foundation is calling for drastic measures to respond to this video. We aren’t concerned that they are reporting on a drug. We are concerned that they are mocking a condition that so many people live with everyday. We encourage you to respond to this advertisement immediately. If you are a subscriber of Consumer Reports, we encourage you to cancel your subscription….”

Here’s a link to the copy of the RLS Foundation’s letter to Consumer Reports.

We applaud Consumer Reports for its new AdWatch feature and for examining the Requip ad. While RLS is a real condition and some people will get relief from drugs such as Requip, the shameless overmarketing of it through ads like this is enormously harmful. The purpose of drug ads is to expand the market for the advertised drug, to convince as many people as possible that they need a particular drug, even if they don’t actually need it. Since 2005, we have been calling attention to and critiquing particularly troublesome drug ads through our Bitter Pill Awards: Exposing Drug Company Manipulation of Consumers. We’re glad to be in the company of Consumer Reports in our efforts.

We’ve been harping on Nexium for several years now. AstraZeneca’s (NYSE:AZN) supposed “healing purple pill” is nothing more than a dressed-up version of its previous blockbuster gastric reflux drug, Prilosec. We gave Nexium a Bitter Pill Award in 2005, the The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag. Our members have been involved in several class action lawsuits alleging the Astra Zeneca deceptively marketed Nexium as an improvement over Prilosec, when in fact it is clinically no different. (As we’re fond of saying, the only difference between Nexium and Prilosec is that Nexium has yellow stripes and costs seven times as much).

We’ve always marveled at why Nexium is as successful as it is when Prilosec is available Over-the-Counter at a fraction of the price. The answer, of course is simple: Marketing. As we’ve written (see, for example “Top 3 Bestselling Drugs spent $460.5 Million on Ads in 2006″), Nexium owes its $4.3 billion in 2006 annual sales to the $176 million that Astra Zeneca spent that year on ads like this:

Now there’s even less of a reason for people to use Nexium instead of cheaper alternatives, including Over-the-Counter Prilosec. FDANews.com reports that Dexcel Pharma Technologies will soon begin selling a generic version of Over-the-Counter (OTC) Prilosec. Astra Zeneca sued Dexcel to prevent it from selling generic OTC Prilosec, but has settled that lawsuit with Dexcel.

Most people think of generics when they think about prescription drugs, not Over-the-Counter ones. But drug companies frequently get FDA permission to stop generic competitors for 3 years when a drug first becomes available over-the-counter. This is why up til now, you haven’t seen, for instance CVS or Walgreen store brand Prilosec.

Dexcel says that OTC Prilosec should be available by the end of March 2008. The competition between Astra Zeneca’s Prilosec and Dexcel’s generic version should drive the price down. This is yet another reason consumers don’t need to pay through the nose for prescription-only Nexium.

But even before you reach for that cheaper box of OTC Prilosec, you should consider whether even less expensive alternatives will do the trick — such as Tums, Zantac, Pepcid, and other over-the-counter heartburn drugs. Consumer Reports Best Buy Drugs has a report on heartburn medicines, and it says, in part:

If you suffer from only occasional heartburn and have not been diagnosed with GERD [gastric reflux disease], nonprescription antacids such as Maalox, Mylanta, Rolaids, and Tums, or acid–reducing drugs such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) will very likely provide relief.

Talk with your doctor about the role that dietary and lifestyle changes can play in alleviating heartburn, too – such as eating smaller meals, weight loss, and avoiding alcohol.

Yesterday IAG Research released “the latest syndicated data for the most memorable new prescription drug ads launched during the 2006/2007 TV season.”

The results were not surprising — some of the drug ads that many of us love to hate topped the list for “memorability.” What’s galling is that even those of us who hate them have been affected by them.

Not surprisingly, a number of winners of PAL’s coveted Bitter Pill Awards were among those most recalled. Our Bitter Pill Awards particularly seek to call attention to those drug ads that elevate image over substance, or that overpromote expensive brand-name drugs that most people don’t need. Among those deemed most memorable were Lunesta (see its While You Were Sleeping Award here), Lipitor (Got Cholesterol? Award here), Crestor (ditto)and Cialis (Performance Anxiety Award here)

IAG’s press release says:

Whether it is a moth, a talking bee or a dead president and beaver, this season’s ranking of the most memorable new ads is dense with unique icons that have become the cornerstone for successful campaign development in this industry. Icons have taken the shape of human and animal figures as well as symbols such as Vytorin’s “food and family” split screen comparison or Cialis “outdoor tubs”.

“The fact that Lunesta along with other prescription brands including Nasonex, Rozerem and Vytorin remain at the top is a testament to strong campaign development that continues to deliver seamless creative extensions that effectively break-through the clutter and reinforce the brand identity synonymous with the icon present in the ads,” said Ms. Fariba Zamaniyan, Sr. Vice President of IAG Research’s Pharmaceutical Practice.

In other words, the key is to find an eye-catching image that “reinforce[s] the brand identity.” What about whether the drug is effective, or what the side effects are, or how it compares to other treatments? Is this information what constitutes the “clutter?”

IAG measured memorability this way:

The Recall Score is the percentage of TV who can recall within 24 hours the ad and the brand they were exposed to during the normal course of viewing TV. These scores are then indexed against the mean score for all new ads during the period (Recall Index). 100 equals average.”

Noticeably absent is anything about whether the viewers could recall anything important about the drug after 24 hours — like the risks and side effects, and who should not take the drug. It’s safe to say that while people probably remember the Lunesta luna moth, they probably don’t remember “In rare cases, severe allergic reactions can occur. Most sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.”

Here’s the list for most recalled ads, courtesy of IAG:

Rank	Brand	Company	Ad Description	Recall Index
1	Lunesta	Sepracor	7-Night Challenge; luna moth flies over bridge and water and into people’s homes/tents. (:60)	157
2	Lunesta	Sepracor	7-Night Challenge; luna moth flies over a lake into couple’s home, then onto woman’s pillow. (:60)	155
3	Zyrtec	Pfizer	Story #43; clothes falls on woman and she sneezes. (:45)	140
4	Nasonex	Schering-Plough	Animated bee talks about prevention of nasal allergy symptoms while buzzing next to Nasonex bottle. (:30)	138
5	Rozerem	Takeda	Abraham Lincoln, talking beaver, man in suit and man in diving suit at a bus stop; your dreams miss you. (:60)	136
6	Lipitor	Pfizer	Dr. Robert Jarvik in white lab coat discusses risk of heart disease and stroke caused by high cholesterol. (:60)	126
	Crestor	AstraZeneca	Man at fish market near ocean whose cholesterol is out of wack; his body splits into various sections. (:60)	126
	Vytorin	Merck/Schering-Plough	Plates of food shown next to shots of relatives such as Grandpa Bow and bowtie pasta. (:60)	126
7	Valtrex	GlaxoSmithKline	Couple talks about the risks of contracting herpes; 70% of people affected got it from their partner. (:60)	124
	Cialis	Eli Lilly	Couples in various romantic places including laying in front of fireplace, in restaurant, in rowboat and laying on hammock. (:60)	124
8	Gardasil	Merck	Young women including a cowgirl, colorguard, gymnast and softball player say they want to be “One Less” (:60)	120
	Caduet	Pfizer	Woman in red vest walks along a beach; splits into two and says she has high blood pressure & cholesterol. (:60)	120

Hat tip: The irrepressible Pharmalot

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.

Stephanie Saul at the New York Times did a great article today, “Sleep Drugs Found Only Mildly Effective, but Wildly Popular” The article dispels the myths concerning the effectiveness of the expensive brand-name prescription sleep aids whose television ads blanket the airwaves every night, including Lunesta (made by Sepracor [NYSE:SEPR]), Ambien and Ambien CR (made by Sanofi Aventis [NYSE:SNY]) and Rozerem (made by Takeda Pharmaceuticals).

We made many of the same points as this article last year when we gave the makers of Lunesta and Ambien/Ambien CR one of our Bitter Pill Awards, specifically the While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep.

Some of the key points that the article made:

• American consumers spend $4.5 billion a year for sleep medications.
• As a group, Ambien, Lunesta and Sonata reduced the average time to go to sleep 12.8 minutes compared with fake pills (placebo), and increased total sleep time 11.4 minutes. Hardly results so impressive that they warrant $4.5 billion in annual spending.
• Two older drugs, Halcion and Restoril, caused people to fall asleep 10 minutes faster and slept 32 minutes longer than the placebo group.

So the newer drugs caused people to fall asleep a whopping 2.8 minutes faster than the older drugs, yet the older drugs increased sleep time almost three times more than the newer. And the price difference? Accordingo to the article, Lunesta and Ambien CR ring in at about $4.00 a pill, generic Ambien at about $2 a pill, and Sonata at $3.50 a pill. The older (now all generic) drugs? 30 to 50 cents. So the older drugs are about equally effective, yet about 1/4 to 1/10th of the price.

As we said last year upon giving the While You Were Sleeping Award:

Ads for insomnia medications are promising trouble-free sleep to an increasingly stressed and sleepless nation. But in doing so, these ads are creating a host of problems: exposing people to dangerous side effects, causing addiction, costing patients and insurers billions of dollars, encouraging them to pop a pill rather than find the root cause of their insomnia, and promoting the dangerous notion that the solution to life’s problems is in a prescription bottle, rather than in changing our behavior, habits and lifestyle.

Last year, the Times ran an excellent article by Jane Brody about alternatives to prescription sleep medications, “Help for Chronic Insomnia Isn’t Always Found in a Pill.”

Stephanie Saul’s article, and the research she reports on, hopefully will begin to encourage people to question the claims in ads for prescription sleep aids, and to explore both the drug-free alternatives and the broader causes behind their lack of sleep.

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.

The New York Times ran an excellent op-ed on Sept 21, “Shy on Drugs,” by Christopher Lane. Professor Lane takes psychiatrists to task for too readily diagnosing shy children as having “social anxiety disorder.” He pins a chunk of the blame on the Diagnostic and Statistical Manual of Mental Disorders (”DSM” for short), the diagnostic bible of the psychiatric profession:

[A] glance at the manual reveals that the diagnostic criteria for shyness are far from clear. The third edition, which was published in 1980, said that a person could receive a diagnosis of what was then called “social phobia” if he was afraid of eating alone in restaurants, avoided public restrooms or was concerned about hand-trembling when writing checks.

The same guidelines could hardly apply to youngsters heading to kindergarten, children not yet potty-trained and toddlers just learning to eat. So in 1987, the revised third edition of the manual expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.

The definition of this “disorder” then sets the stage for wholesale manipulation by pharmaceutical companies all too eager to offer up a pharmaceutical solution:

Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline [NYSE:GSK], the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (“Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone…social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent — higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.

In 2005, we gave one of our Bitter Pill Awards to GlaxoSmithKline for its marketing of Paxil, the Cure For the Human Condition Award. We pointed in particular to this fact:

In June [2005], the FDA issued a warning letter to GlaxoSmithKline for its “Hello, My Name is.” television ad campaign for Paxil. The FDA said that this ad wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR” when these are simply not approved uses of the drug. Despite the warning letter, the harm had already been done as millions of consumers had already seen the ad.

This type of marketing, and the widespread diagnosing of shy children (and adults) as having a medical disorder as opposed to run of the mill shyness, is often cited as an example of “disease mongering.” It’s a symptom of a larger problem — the medicalization of an ever-increasing portion of the spectrum of normal human behavior. Anything that deviates from some pharmaceutically-determined median is now a candidate for an expensive, brand-name drug, from how shy we are to whether or not we occasionally can’t sleep to whether our legs twitch when we sit still to whether we have toenail fungus.

The prescribing of expensive, strong and often dangerous prescription drugs to ever growing numbers of children with shyness is ironically happening at the same time that an also every growing numbers of children are being prescribed expensive, strong and often dangerous prescription drugs for Attention Deficit Hyperactivity Disorder (ADHD). Children generally are being prescribed more and more prescription drugs, even when such drugs have often not been tested on or approved for children. (We reported on another example recently: “Doctors widely prescribing drugs for kids’ sleep problems”)

There are no doubt some children who benefit from SSRIs such as Paxil and drugs for ADHD, for whom the benefits outweigh the often considerable risks. But they are undoubtedly a fraction of those children who are prescribed these drugs. We as a society are turning too quickly to the pharmacist for a solution to complex issues. Shyness, inability to pay attention, hyperactivity — these are not merely — or often even primarily, if at all — medical or biochemical issues. They’re affected by a broad range of factors, such as class size, nutrition, sleep, the quality of housing and one’s environment, the stability of home and family life, etc. It’s far easier to write a prescription than to tackle these larger problems. But the underlying problems will remain. Pharmaceutical companies are all too willing to pitch their solution, regardless of the harm it causes or whether it actually addresses any underlying problem.

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.

In the wake of the drug safety scandals of the past few years (Vioxx, Celebrex, Paxil, etc), there were widespread predictions that Direct-to-Consumer Advertising (DTCA) of prescription drugs (TV commercials, magazine ads, etc) would become less prevalent and less effective. Both predictions have proven false — spending on consumer drug ads hit an all-time high in 2006 of $4.8 billion. And the makers of the top three best-selling drugs in the U.S. in 2006 spent a combined total of $460.5 million on drug ads last year. See the chart below.

(Sources: IMS Health, “Top 10 Products by U.S. Sales”, and DTC Perspectives, June/July 2007)

Of course, not every prescription for these drugs is due to advertising. But, for each of these drugs, aggressive advertising to consumers has significantly contributed to their sales. The worst (or best, depending on your perspective) example of this is Nexium. Nexium, the so-called “healing purple pill” is nothing more than an isomer of Prilosec — in essence, Nexium is a molecular “mirror” of the Prilosec molecule. However, there’s essentially no difference between Nexium and Prilosec in terms of their effectiveness. AstraZeneca has aggressively marketed Nexium as though it were some miraculous improvement, despite an amazing lack of evidence that this is the case.

For this, Nexium earned one of Prescription Access Litigation’s coveted “Bitter Pill Awards” in 2005: The “Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag.” It is truly a strange world in which a drug that is essentially no better than its now-much-cheaper predecessor can rake in $4.3 billion in sales in the U.S. alone. The reason? Aggressive marketing — not just to consumers, but to physicians as well.

It calls to mind an excellent quotation by Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of The Truth About the Drug Companies:

T]o rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism…The fact is that marketing is meant to sell drugs, and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.”

And that’s enough right there to give you heartburn.

One of last year’s Bitter Pill Awards honorees, Lunesta, has the dubious distinction of having the most recalled and most remembered drug ads on TV, according to IAG Research.

In 2006, we gave Lunesta and Ambien our “While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep.” At the time Sepracor was topping the charts in Direct-to-Consumer Advertising spending for drug companies, in an aggressive push to gain market share over Ambien and Ambien CR.

The ubiquitous “Luna Moth” ads have become the archetype of current drug ads, lulling the critical faculties of viewers into a slumber, and making even the deepest sleeper wonder if they should Ask Their Doctor about Lunesta.

Lunesta’s sales growth has been hampered by Ambien going generic (reports of sleep-eating, sleep-walking, and sleep-driving notwithstanding) and by competition from the latest entry into the prescription sleep drug market, Rozerem. So what does the forward-thinking company do in the face of lagging sales? Why, raise the price, of course! Yes, Ed Silverman at Pharmalot reports that Sepracor has raised the price of Lunesta 9%, on top of an earlier 9% price hike in November.

Further, Sepracor continues to violate PhRMA’s “Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines,” specifically Principle 10, which states that:

DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

Sepracor continues to run so-called “reminder ads” for Lunesta, those brief spots which say the name of the drug but nothing else about it. Such ads are designed to increase name recognition, much in the same way that lawn signs and bumper stickers do for electoral candidates. Since they don’t say anything about what the drug is used for, under FDA regulations, they aren’t required to list the major side effects and other information we see in full drug ads.

What has PhRMA done about such violations, which they have been repeatedly informed of? N o one knows, since their report on the first year of the Guiding Principles and “comments” they received from consumers named no names and was widely considered to be a whitewash.

(Speaking of Ambien’s now-famous side effects: As is the case so often on matters of importance, perhaps the most thoughtful commentary on sleep drugs and their risks is, of course, from the Simpsons:)