Not so fast, Lunesta

Watching a fight between the FDA and Big Pharma is like getting to watch your grandfather holler at your dad.  It's kind of a thrill, but then you think, "well whose fault is that?"

About a month ago, when I meant to comment on this, but was clearly busy doing something else,  the FDA called Sepracor on a Lunesta ad that seemed to tell less than the whole truth.

The offending claims ("misleading" is how the Division of Drug Marketing, Advertising, and Communications described them) included a suggestion that Lunesta is better than other products. In an advertisement? gasp.   Turns out they can't say so unless they can prove it.  A good enough rule, I suppose.  Are these the same rule makers who say it's ok to market a drug as long as you admit (in voiceover and onscreen) that you have no idea how it works?

What's worrisome is wondering what in the world Sepracor wouldn't say about Lunesta if this is what they will say?

"LUNESTA acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep."
read: Lunesta is made out of ether.


"Walking, eating, driving or engaging in other activities while asleep without remembering it the next day have been reported....Side effects may include unpleasant taste... "
Read: Mind Erasers taste better

"Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal."
Read: People who live alone should not take Lunesta

This next bit is not from the official website, but is my favorite case for the drug being worse than what you took the drug for.  (U.S. National Library of Medicine National Institutes of Health)

You should know that some people who took medications for sleep got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep.After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.

Imagine the fine print:

The actual ad in question featured a woman sleeping in a boxing ring, which has been removed from the air at this writing.   DDMAC called the makers of Rozerem, another sleep aid, on the same offense (unsubstantiated superiority claims).  Pay attention here:  Rozerem, made by Takedo, whose former general manager is now Chairman of Sepracor.

messy, messy, indeed.