On Feb 6, David Lazarus, writer of “Consumer Confidential” for the Los Angeles Times, wrote an article on drug advertising, “Ads spur urge for drugs“. The article didn’t break any new ground in its analysis of how drug ads spur people to ask for drugs they may not need, but was a good overview of the issue.

Lazarus focused on a new Direct-to-Consumer ad campaign for Provigil, which originally was approved by the FDA to treat narcolepsy and is now also approved to treat “excessive sleepiness associated with obstructive sleep apnea.” The ads claim that Provigil can “fight the fog.”

Lazarus reports this telling exchange:

Jenifer Antonacci, a Cephalon spokeswoman, said the new DTC campaign is merely intended to raise awareness about excessive sleepiness.

“We’ve decided to take a leadership role in this area,” she said. “Our goal is to help educate consumers about excessive sleepiness and start a dialogue between patients and their physicians.”

While Provigil is being marketed as a remedy for fatigue resulting from sleep apnea, it’s not hard to imagine on-the-go people in today’s 24/7 world seeing the drug as a nifty way to cram a few more hours of wakeful activity into already crowded days.

Why settle for a venti latte at Starbucks when you can get the same kick (and possibly more) from a little pill?

Antonacci described a potential Provigil user as someone who repeatedly finds himself nodding off on the couch while watching TV at night.

“That’s me!” I responded.

“Maybe you have sleep apnea,” Antonacci observed.

So don’t be surprised if a lot of consumers who now ask their doctors about Provigil don’t have obstructive sleep apnea, shift work sleep disorder or narcolepsy, the only three conditions for which using Provigil to treat “excessive sleepiness” is approved. And don’t be surprised if those doctors write a prescription for those patients anyway:

Some doctors I’ve spoken with say they’ll suggest generic equivalents or alternative approaches. But if patients are determined to try a name-brand drug they’ve seen pushed on TV or in the paper, it’s often not worth the trouble trying to talk them out of it.

And studies bear this out. When patients ask their doctors for drugs they’ve seen on TV, doctors will prescribe them in much higher numbers than if the patients didn’t ask for an advertised drug by name. See, for instance, a study published in 2005 in the Journal of the American Medical Association: Influence of Patients’ Requests for Direct-to-Consumer Advertised Antidepressants

It strikes me as highly ironic that two very big markets for prescription drugs, and that feature lots of ads, are (1) drugs to help you fall asleep (Ambien, Ambien CR, Lunesta, Rozerem) and (2) drugs to help you stay awake (Provigil). It suggests that perhaps the problem is not a medical one, but a social one — we as a society just don’t get enough sleep. And no amount of pills will solve that. No matter what drug ads claim.

Or, as Lazarus put it:

I asked Antonacci what else could cause excessive sleepiness.

“The No. 1 cause of excessive sleepiness is not getting enough sleep,” she replied.

I’m no doctor, but the remedy for that seems simple enough.

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.

WebMD reported last week on a new study in the journal Sleep. The study found that doctors are widely prescribing sleeping pills and other drugs to children having sleep problems. An astonishing 81% of the 18.6 million doctor visits studied included a prescription being written. By contrast:

They found that diet and nutritional counseling were advised for 7% of children and that 22% were prescribed behavioral therapy such as psychotherapy and stress management to relieve the sleep problems. For 19% of children, both behavioral therapy and medication were advised.

The data studied only go til 2004. Advertising for sleep drugs has exploded since 2004. Both Lunesta and Rozerem were introduced after that time, and have been extremely heavily advertised. Ambien CR was also widely advertised in that time period, both to compete against these new drugs, and to get patients to switch from Ambien to Ambien CR before generic versions of Ambien came on the market. (In 2006, we gave one of our coveted Bitter Pill Awards to the makers of both Lunesta and Ambien/Ambien CR – the “The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep”) It is likely that the enormous promotion of prescription sleep aids in the past 2 and 1/2 years has increased the number of kids being prescribed drugs for sleep even more.

Several things about these findings are disturbing:

• It suggests that doctors are rushing to medications, and not adequately addressing underlying causes, or emphasizing behavioral changes and “sleep hygiene.”
• Many of the drugs being prescribed have not been tested on children, and are not FDA-approved for use in children — this is so-called “off-label” usage. While off-label prescribing is quite common (one study found that 1 in 7 prescriptions was for an off-label use), it is potentially more troubling when it is done for children. Children are not “little adults” — it cannot be assumed that a drug will work the same, or that side effects and risks will be similar for children as they are for adults. The effects of drugs on children’s growth and development is unclear if the drug has not been studied in children and is not approved for use in children.
• It exposes children to the risk of addiction or dependency. Many drugs used for sleep problems have these risks, even those that are not specifically approved for insomnia.
• It introduces children at an early age to the dangerous idea that there is a pill for all their problems, and that taking prescription drugs is “no big deal,” and just a routine part of everyday life. This cultural attitude has contributed to the extremely troublesome and widespread trend of teenagers and young adults misusing and abusing prescription drugs.

For some children, the use of a prescription drug may be the appropriate route for addressing a sleep problem. Insomnia and other sleep problems can and do interfere with children’s growth, learning and behavior, and need to be addressed. But it is a sad commentary that millions of children are being prescribed prescription drugs, when for many of them, changes in diet, routine and schedule would work just as well and not expose them to the risks, known and unknown, that come with these prescription drugs.

The Sleep study can be found here.

Postscript:
In a bit of irony, the article on WebMd was bordered on two sides by an ad for Rozerem. See screen shot below: