Tuesday, October 23, 2007

Takeda's Clinical Symposia: It's all about Rozerem

Today's New York Times has a nice piece by Stephanie Saul on sleeping pills, entitled "Sleep Drugs Found only Mildly Effective, but Wildly Popular." She covers a recent NIH-funded report which concludes that sleeping pills "reduced the average time to go to sleep 12.8 minutes compared with fake pills, and increased total sleep time 11.4 minutes." Saul focuses particularly on Rozerem, which has been heavily promoted in direct-to-consumer ads, and yet was found by NIH to be one of the less effective pills. To quote Saul: "Consider that it costs about $3.50 a pill; gets you to sleep 7 to 16 minutes faster than a placebo, or fake pill; and increases total sleep time 11 to 19 minutes."

I am not anti-sleeping pill by any means. I prescribe plenty of them, and sometimes take them myself. They certainly work. But I am not convinced that the brand-name pills are worth their higher prices. I prescribe plenty of trazodone, temazepam, and diazepam for sleep, as well as generic Ambien (zolpidem). Occasionally I'll go to pricey Ambien CR for patients who like Ambien but who wake too early in the morning.

I have had a grand total of one patient respond to Takeda's Rozerem. Nonetheless. The journal Clinical Symposia, in a recent edition sent free to all physicians, likes Rozerem so much that it highlights the melotonin receptors on the picture of the brain on the cover (see above). That seemed odd to me, since this was an issue on insomnia for primary care physicians, and Rozerem is hardly the drug that PCPs would or should turn to first when treating insomnia. Once I flipped it over, the mystery was solved, as this entire issue was sponsored by Takeda. In addition, the first author, Gary Richardson, M.D., is a prominent Takeda speaker. See, for example, this website, "SleepJournalClub.org," chaired by Richardson, funded by Takeda, and providing CME credit for reading journal articles on insomnia. I suggest you click on "archived events" and scan through the 11 articles posted thus far. I went through this exercise in an effort to determine whether the articles chosen were biased either in favor of Rozerem or against its competitors. Here's what I found:

1. Effects of NG2-73 On Sleep Onset, Quality and Next Day Function In a Transient Insomnia Study. A clinical study of a new compound, NG2-73, manufactured by Neurogen, which acts as a partial GABA agonist. Does not promote Rozerem.

2. A Review of the Evidence for the Efficacy and Safety of Trazodone in Insomnia. A review of trazodone concluding that it has little supporting evidence as a hypnotic and that is has significant side effects. Promotes Rozerem by trashing its main generic competitor.

3. Highlights from APSS (a sleep conference) 2007. Reviews a study showing that Ambien causes the elderly to be shaky on their feet, and refers to Takeda-funded studies (read abstracts here) showing that Rozerem does not have this liability. Promotes Rozerem.

4. The Brain’s Master Circadian Clock: Implications and Opportunities for Therapy of Sleep Disorders. Emphasizes the importance of the melatonin system in insomnia. Promotes Rozerem.

5. Safety of Ramelteon in Individuals With Mild to Moderate Obstructive Sleep Apnea. Need I say more? Promotes Rozerem.

6. Combined Therapeutics for Insomnia: Should our First Approach be Behavioral or Pharmacological? Unsponsored paper on therapy vs. meds for insomnia. Does not promote Rozerem.

7. Tiagabine Enhances Slow Wave Sleep and Sleep Maintenance in Primary Insomnia. Promotes Tiagabine.

8. Influence of Pharmacokinetic Profiles on Safety and Efficacy of Hypnotic Medications. Funded by Sanofi, maker of Ambien CR, this article is strongly and cleverly promotional of Ambien CR.

9. The Management of Insomnia: From Herbals to Hypnotics. While this is a review of all sleeping pills, it ends with several extraordinarily positive statements about Rozerem (eg., "The selective melatonin receptor agonist ramelteon represents the first major advance in the treatment of insomniain more than 40 years.") Promotes Rozerem.

10. Insomnia and Hypnotic Use, Recorded in the Minimum Data Set, as Predictors of Falls and Hip Fractures in Michigan Nursing Homes. Study showing that hypnotics do not increase the risk of nursing home fractures; rather, insomnia does. While this is not specifically promotional of Rozerem, this fits in well with Takeda's promotion of Rozerem as being safer than Ambien for the elderly. Promotes Rozerem.

11. Relative Abuse Liability of Hypnotic Drugs: A Conceptual Framework and Algorithm for Differentiating Among Compounds. This article, sponsored by Takeda, is essentially a prolonged advertisement for Rozerem, highlighting its main advantage: lack of abuse liability. Promotes Rozerem.

Conclusion? In my analysis (certainly biased by my heightened sensitivity to underlying promotional agendas), 7 out of 11 articles in this Takeda-sponsored CME program are promotional of Rozerem.

Mais bien sur, you say. Why else would Takeda pay Richardson and colleagues to chair this journal club? If they didn't choose articles that made Takeda happy, these physicians would be "missing their dreams" of fat honoraria checks!

1 comment:

Anonymous said...

Just found your blog. Outstanding and necessary. Keep up the good work.
-Robert Ashley MD