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Dr Stone’s Pharmonitor essay justly skewers drug promotion hubris disguised as a CME article.
 

But hold on a minute. Last year I read a favorable review for low dose doxepin HCL in Dr Steven Stahl’s Essential Psychopharmacology (third edition). When late night reading of CME articles failed to induce my sleep, I tried 10 mg doxepin (the smallest dosage preparation available). It seem to work well-sleep onset and duration both satisfactory, and no morning sleep hangover. I tried it on the next 10 patients with sleep complaints, and 9 liked it. Now I’m up to 30 patients and 65% approve, a respectable showing for most of our interventions.

I have great respect for the acumen and caution of the FDA. But isn’t this an instance when ordinary clinicians can take a drug with low risk (at 10 mg) and low cost (about 14 cents) and draw meaningful conclusions from clinical populations?

Donald H. Taylor, DO DLFAPA
Clinical Professor, George Washington University
 

Dr Stone Responds:
Dr Taylor’s clinical experience is intriguing. Hopefully his report will stimulate more systematic study, but who will pay for that research? My understanding is that the FDA was not deciding whether 10 mg of the antidepressant Doxepin was an effective sleep remedy. They were being asked to decide whether the same chemical compound researched and marketed as a sleep aid in lower dosages by a new start up corporation would be safe and efficacious. I cannot offer a complete or authoritative legal analysis but my understanding is that the new enterprise did not “own” 10 mg Doxepin and could profit only from the drug as they produced and researched it in lower dosages. They risked millions of dollars in the effort. 

If I am correct and Dr Taylor’s experience is validated, it may well be a boon for insomniacs-but not for entrepreneurs.  
 
Alan A. Stone, MD
Touroff-Glueck Professor of Law and Psychiatry in the Faculty of Law and the Faculty of Medicine
Harvard University