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Safety of new sleep medication challenged by watchdog group

Safety of new sleep medication challenged by watchdog group

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"You can't see me because this is radio--and I can't see you because I am blind." So began an aggressive ad campaign Vanda pharmaceuticals rolled out last year for "non-24-hour sleep-wake disorder."  In the ad campaign the narrator says he is blind but his blindness doesn’t “hold me back” the way non-24-hour sleep-wake disorder does--because the latter finds him struggling "to keep up” since he is not “sleeping through the night.” The condition, mainly affecting people with blindness, causes tiredness during the day. He then says, “Sound familiar? You’re not alone!” 

Now the watchdog group Public Citizen is charging that the FDA inappropriately expanded the approved use of Vanda's drug, Hetlioz, for the disorder beyond its original indication for use in blind people. According to Public Citizen, the drug was approved for use in blind people not all people yet its label omits that important limitation.

Not only is the drug, which made $12.8 million last year, inappropriately labeled, its safety data do not include clinical studies of people who have non-24 sleep-wake disorder and are not blind, says Public Citizen. The approval appears to be a direct violation of the Federal Food, Drug, and Cosmetic Act which requires demonstration of safety and efficacy in the group for whom a drug is approved.

When I called the toll-free number that was first advertised, I asked the "health educator" if I could have non-24 even though I am not blind. He told me "you don't have to be blind to have non-24" though it is more common in blind people. When I asked if there were a pill I could take if I had symptoms, my educator said he was unable to answer because, "I am not a doctor," but promised to send me more information. 

Non-24 is not the only rare sleep disorder for which drug companies are raising "awareness" and marketing expensive drugs. A few years ago, the drug company Cephalon aggressively publicized a condition called "shift work sleep disorder" (SWSD) for which it made the drugs Provigil and Nuvigil. The condition was characterized by "trouble focusing, increased irritability and poor work performance" said, a website created for the disease which has since been taken down.

"Just improving your sleep may not improve your ability to cope with shift work," said the site which offered a self-assessment quiz and chance to "take action" and "tell a friend." Like many disease awareness campaigns, which are called "unbranded advertising," the site did not mention any drugs.

Another rare sleep condition for which Jazz Pharmaceuticals makes a medication is narcolepsy. Signs of the condition include an "uncontrolled urge to sleep," "poor quality sleep" and other symptoms but people do not "need to experience all of them to have narcolepsy," says Jazz.

Needless to say, symptoms of shift work sleep disorder, non-24-hour sleep-wake disorder and narcolepsy could be from not getting enough sleep or other factors, especially since there are no definitive lab or blood tests to verify the conditions.

The new sleep drugs are shockingly expensive. Thirty 150-milligram Nuvigil pills cost a walloping $656.10. Xyrem, the narcolepsy drug costs "$35,000 per year" according to Jazz president Bob Myers. And Hetlioz, the mislabeled drug for non-24? "A typical fill can cost $8,278 or more for 30 capsules," its yearly cost well over $60,000 a year! Nor are there data that Hetlioz even works in the people to whom it is marketed.



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