What data are they looking at?

Germany has approved modafinil (Provigil in the US, VIGIL in Germany) for chronic shift work sleep disorder with excessive sleepiness. The European head of Cephalon, the drug’s maker, obviously happy to have something new to market, has this to say:

This new indication capitalizes on the strong clinical data surrounding this medication and allows us to improve the quality of life of the people suffering from this debilitating disorder

But is modafinil actually useful for this disorder? Last month I posted about a NEJM article Modafinil for Excessive Sleepiness Associated with Shift-Work Sleep Disorder, whose Cephalon-funded author put a positive spin on the very weak results that the study showed. There was also an accompanying editorial criticizing the study. My view was that NEJM shouldn’t have published the article at all.

A commenter quite rightly pointed out that…

…a critical reader doesn’t need an editorial to draw the conclusion that the drug isn’t much good

I responded that I worried the article would be one more arrow in Cephalon’s quiver that they don’t deserve to have. After the German approval, I’m still worried about that. I’m sure Cephalon will distribute thousands of reprints of the article (or worse yet, just the abstract) and none of the accompanying editorial.

I also wonder what data the Germans used to make the approval.

September 6, 2005

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