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Insomnia Pill Makers Go After Elderly With New 'Fear of Falling'

By Jim Edwards | Sep 11, 2008

200px-lifecall-1.jpgFor years, drug companies have tried to expand the range of prescriptions of sleeping pills. They’re not just for sleeping any more — now they’re also for avoiding “rebound insomnia” in the elderly, “increased risk of automotive crashes, decreased work performance … or mood changes,” generalized anxiety disorder, and depression.

So it shouldn’t surprise anyone to discover that researchers with close ties to drug companies  are trying to figure out whether insomnia in elderly women is more likely to make them fall, and risk bone fractures.

This study, “Less Sleep Linked to Greater Risk of Falling in Elderly Women,” was published a couple of days ago. (Not registered? It comes up for free on Google.) After looking at 2,978 women, it concludes that “Women who are aged 70 years and older who sleep 5 hours or less per night may be more likely to experience falls than those who sleep more than 7 to 8 hours per night.” The study will be published in the Archives of Internal Medicine.

So, all those female seniors who find themselves wide awake at 5 a.m. should just pop a pill, in case they fall over, right?

Readers will be unsurprised to learn that the paper’s authors have links to drug companies that make sleep drugs. Here’s the now-familiar disclosure, about half-way down the above item:

Dr. [Katie L.] Stone is a consultant for Sepracor Inc and an invited speaker for sanofi-aventis. The second author, Sonia Ancoli-Israel, is a consultant and on the scientific advisory board for Arena, Cephalon Inc, Neurocrine Biosciences Inc, sanofi-aventis, Sepracor Inc, and Takeda Pharmaceuticals North America Inc and has received grant support from Sepracor Inc and Takeda Pharmaceuticals North America Inc.

Stone and Ancoli-Israel certainly seem to have hit all the bases:

  • Sepracor markets Lunesta.
  • Sanofi markets Ambien and Ambien CR.
  • Cephalon markets Provigil.
  • Neurocrine is developing indiplon.
  • Takeda markets Rozerem.
  • Arena is developing an insomnia compound titled APD125.

That’s six conflicts between just two people! Is this a record?

But take a closer look at the paper they have authored. While the headline suggests that getting a really good night’s sleep will be less likely to leave you crying “I’ve fallen and I can’t get up!,” the nitty-gritty data almost suggest the opposite. “The use of benzodiazepines did not explain [the] association” between long sleep and lack of falls, the pair write. Worse — for the drug companies anyway — are the study highlights:

Frequent fallers were … more likely to use benzodiazepines or antidepressants and to report daytime sleepiness.

Use of any benzodiazepine was associated with increased risk for falls

It is not clear whether it is the poor sleep or the use of sleep medications that affect the risk for falls.

I’m going to take a wild guess and say that sales reps will be flashing the headline on this study to docs with large populations of elderly women in their practice, but they won’t spend nearly as much time pointing out all the caveats.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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    pharmaguy

    09/12/08 | Report as spam

    RE: Insomnia Pill Makers Go After Elderly With New 'Fear of Falling'

    Great analysis, Jim.

    As for sales reps showing docs this study -- even the headlines -- it may not be kosher according to FDA off-label promotion regulations, if it's implied that insomnia meds can prevent elderly falls. Also, a physician must specifically ask for article reprints and those requests are -- or should be -- handled by the medical people within the pharma company.

    The FDA is trying to make it easier for sales reps to distribute unsolicited journal reprints to docs; see "Pharma's New Marketing Partner: Medical Journals" at http://tinyurl.com/4ayqvp

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