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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.


Anonymous said...

I agree with you about the concept of disease mongering. However,"ES" is certainly a leading cause of single car accidents and deaths.
Maybe,the new drug isn't the answer,but it is a real problem. If we can identify people at risk,we will at least be ahaead of the game. Certainly,it deerves as much attention as a paniced public,spends on West nile virus,etc.

Anonymous said...

Your blog came up in a search about provigil.
I'm a provigil patient. I take it for narcolepsy and rheumatoid arthritis. I am skeptical about my narcolepsy disgnosis, but am not skeptical over the fact that fatigue pretty much rules my life, with or without provigil. (I build up such a provigil tolerance that I can't take it regularly -- just as needed).

I have recently read "The Promise of Sleep" by Dr. Dement and I am convinced that we are, to use his words, "a sleep sick society." Having doctors screen for excessive sleepiness would save lives that otherwise might be lost to accidents or to complications of untreated apnea. (blood pressure, heart attacks etc.) It's so normal in our society to be tired that many don't realize that an adult getting 8 hours or so of sleep SHOULDN'T be tired. And considering that sleep quality is a good predictor of health, well, I think doctors should be concerned.

Is provigil the answer?

I don't think another drug is needed for most the population. But attention to sleep is very needed.

Anonymous said...

Well, I agree that we are becoming a "medicated society." I've never used a medication before. One day before I turned 50, I began to use Provigil. That was 2 months ago. This medication has helped me tremendously. I was experiencing difficulty staying awake during the day, my productivity was diminishing and my happiness level was declining. My doctor did three seperate sleep studies before prescribing so I felt secure about giving it a shot. It has made a tremendous difference for me.

I'm also a licenced clinician (though not a physician) and I take medical treatment seriously. So, for what it's worth, this has helped me.