The August 4, 2005 issue of the NEJM has an interesting article on the new "alertness" drug, modafinil, and an editorial that expressed skepticism about its value.
5-10% of shift workers exhibit daytime sleepiness and on shift drowsiness to a significantly greater degree than most other workers.That sub group is the current target for the proposed use of modafinil which would hopefully improve the quality of life for these folks and increase productivity as well as perhaps have a favorable effect regarding safety issues.If the disturbance are deemed severe enough the diagnosis of shift-work sleep disorder is made replete with an ICD code. ( Since this has become a codable disease,one wonders if an employer firing a worker for being too sleepy at work would be at risk for an EEOC action.)
The authors conclude that modafinil is "of some value in the clinical management of sleepiness associated with shift-work disorder".It has been approved by the FDA for the treatment of excessive sleepiness associated with shift-work sleep disorder.The editorialist, Dr. Robert C. Basner,quotes a 2002 published comparison with caffeine saying that improvements in performance and vigilance with modafinil were similar to 600 mg of caffeine. For reference,a Pepsi has 55 mg of caffeine,Red Bull, 80 and drip coffee, 110-175.Max strength No Dose is a 200 mg caffeine tablet.
So the results from modafinil are less than spectacular.
Perhaps more interesting were the comments made by the authors that data was fully accessible to all of the authors and the sponsor(in this case the manufacturer of modafinil) placed no limits on the interpretation or publication of the data.This type of reassurance will likely become part of the boilerplate of medical articles.This hopefully represents more evidence that there is a bit of meaningful push-back to the alarming role that some drug manufacturers have had in the control and manipulation of data from clinical trials. Certaintly there is much more awareness of that possibility now and journal editors and journal readers look at drug trials in different way.