The Boston Globe reported that several "high-profile psychiatrists" say that Sepracor is misrepresenting the new sleeping pill (see "Doctors criticize sleeping-pill ads").
One print ad says Lunesta is "the first and only prescription sleep aid approved for long-term use." Similar phrases appear on Sepracor's website for the drug, lunesta.com, and in television ads.The problem is that the labeling does not indicate how long the drug can safely be taken. The FDA merely did not require the label to specify that the drug is for "short-term" use, as it has for other insomnia drugs.
Ordinarily, I might let this slide, as the FDA seems to be doing. However, DTC ads are now under close scrutiny by the public and, obviously, by physicians. The industry has promised that they will consult with physicians before running DTC ads for new products. Obviously, Lunesta was launched before the new PhRMA DTC guidelines were endorsed by Sepracor. The guidelines don't go into effect until 2006 anyway. The Lunesta ads do not, therefore, violate the letter of the guidelines, but they bend the spirit.
I grew more suspicious that deception was actually intended after I listened to the December, 2004 investor conference call announcing the Lunesta launch. In this call, Timothy J. Barberich, Chairman of the Board and Chief Executive Officer of Sepracor, was careful NOT to say that Lunesta was "the first and only prescription sleep aid approved for long-term use." What he said was: "Lunesta does not have a short-term restriction in its product label..."
Corporate executives can go to jail if they misrepresent facts, especially to investors. I am sure Barberich had this in mind when he made his presentation to investors immediately following the forward-looking statement. Marketers, on the other hand, are free to misrepresent facts, but only at the risk of being convicted in the court of public and physician opinion. Sepracor and Lunesta may already have been convicted in this court.