Friday, December 30, 2005
Is promotion of "excessive sleepiness" the latest example of disease mongering
I previously posted about the notion of "disease mongering" . Ads are recently appearing alerting the public and/or the medical profession to the "common and debilitating" of excessive sleepiness (ES). The Epworth Sleepiness scale is recommended to determine if your level of sleepiness rises to the level of being designated as "excessive".The reader is told that 50 % of work related accidents and 25% of household accidentss are due to ES,it is common in depression (as many as 1 our of 5), 80% of Parkinson pateints have it and, of course, it is common in patients with obstructive sleep apnea (no argument there). I also posted about a new alertness drug,modafinil, which was featured in an NEJM article and was accompanied by a somewhat skeptical editorial.In Jan. 2002 the FDA sent Cephalon (modafinil's manufactuer) a warning letter for "false and misleading material" which promoted its use for sleepiness and lack of energy when at the time it was only approved for narcolepsy. In October 2003,the FDA expanded the approved use to obstructive sleep apnea/ hypopnea related sleepiness and to sleepiness due to shift work sleep disorder.Interestingly, even though the Cephalon ES advertisement mentions Parkinsons disease as a condition in which excessive sleepiness may be a issue, a recent RCT from Baylor Medical School failed to show any benefit from modafinil in Parkinson patients.In 2005 a number of RCTs were published that evaluated modafinil in:ADHD,Obstructive Sleep Apnea,shift work shift disorder,cocaine dependence,shizophrenia,patients with incomplete response to SSRIs and as an analgesic potentiator. There were with mixed results. It may well prove to be of some value in several conditions but my concern is with the advertisement approach in which physicians are encouraged to "screen" for ES as it is "often unreconized and untreated".Physicians are encouraged to include the Epworth Sleepiness Scale into "routine evaluations".I wonder if we be seeing that ES seminars will be part of the medical meeting scene and "thought leaders" will be discussing the latest research involving modafinil in a variety of conditions and patient advocacy groups will enlisted and can direct to consumer advertizing be far behind. In short the whole disease awareness campaign to promote a condition as serious,common,underdiagnosed and treatable might be gearing up.Interestingly,today (12/3o/04) I received in the mail an invitation for a seminar worth 4 hrs. of CME on the topic of excesssive sleepiness.I'm going to pass on this one.