Would you risk your life to ease jet lag?
Jet Powered
How do you sell a drug in 2010?
You sell the DISEASE, not the drug.
Come on, Cephalon! You shouldn’t need to have this explained by an alternative health writer. That’s just embarrassing.
Cephalon has been has been making drugs for just a couple of decades, so I guess I shouldn’t be too hard on them. But they dropped the ball with Nuvigil–a “wakefulness” drug that was just denied FDA approval as a treatment for jet lag.
And there’s your problem right there: jet lag. You can’t call it jet lag. Jet lag is an inconvenience. Did you really expect the FDA to rubber stamp an expensive drug with dire side effects just to treat…jet lag?
Cephalon executives were on the right track when they received their original approval of Nuvigil to treat excessive sleepiness (ES) due to sleep disorders such as obstructive sleep apnea, shift work, and narcolepsy.
And what was the magic word in that last sentence? Disorders. You don’t want to treat jet lag, you want to treat Jet Lag Disorder (JLD). Or better: Jet Lag Syndrome (JLS). Or best: Acute Jet Lag Syndrome (AJLS).
Now we’re getting somewhere!
You go to the FDA with a couple of experts who detail the horror stories of patients who have gone on post-trans- Atlantic-flight rampages or driven cars into lakes–all due to AJLS. Careers ruined, marriages failed, etc., etc. You make some TV ads that warn of the lifetime of heartbreak caused by AJLS. THEN you apply for the FDA approval.
See how that works?
Of course, it helps if you have a tight study to go with it. According to Cephalon reps who spoke to the New York Times, FDA officials questioned the “robustness” in the evidence from the Nuvigil jet lag trial.
And when you consider the side effects of Nuvigil, you better have a boatload of robustness.
According to the Nuvigil website (nuvigil.com), the drug may cause a “serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening.”
And then you also need to watch for “hives, sores, swelling, or trouble swallowing or breathing.”
And don’t forget you might also experience “chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide, aggression, or other mental problems.”
Yikes! Compared to all that, Acute Jet Lag Syndrome sounds sort of appealing.
But the unique appeal of Nuvigil just might be the most significant side effect.
On one website where the Nuvigil jet lag study was reported, a reader shared his experience with Provigil–a drug also made by Cephalon. Provigil’s patent will run out in two years, so Cephalon refashioned it into a new drug– Nuvigil–which does exactly what Provigil does, but the wakefulness effects last a bit longer.
In his comments, the Provigil user describes a normal day, popping 200 mg of Provigil, drinking a cup of coffee, and then…stand back! “You are in for one hell of a productive morning.”
But he cautions, “Patient beware!” In his opinion the drug is habit forming because once he used it, he felt like he was performing at about 25 percent of his potential without it.
Easy to see how a dependency could develop–especially when doctors are quick to pull out the prescription pad. According to the New York Times, Provigil and Nuvigil are sometimes prescribed, “just to help healthy people get by on less sleep.”
Say…we might be on to something here: an antidote for the effects of Nuvigil! We could call it Acute Wakefulness and Sleep Deprivation Syndrome (AWSDS).
Cephalon! Get to work on that!
To Your Good Health,
Jenny Thompson
Sources:
“Regulators Reject a Drug Maker’s Plan to Use Its Alertness Pill to Overcome Jet Lag” Andrew Pollack, New York Times, 3/29/10, nytimes.com
“A Drug’s Second Act: Battling Jet Lag” Andrew Pollack, New York Times, 1/7/10, nytimes.com
