Is Cephalon's Provigil Addictive? Ask the Cocaine-Using Monkeys It Was Tested On.
Cephalon is dealing with a PR storm over the question of whether Provigil, its sleep disorder drug, is addictive or not. A study by the National Institute on Drug Abuse suggests that it is:
Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA), report[s] evidence that Provigil might be more addictive than thought.
“There is an increasing use of this medication, and people have promoted the off-label use of stimulants and Provigil as cognitive enhancers with the belief that these drugs are safe,” Volkow tells WebMD. “But these drugs have side effects, and their use without proper medical oversight could lead to abuse and addiction.”
Couple the addiction issue with Cephalon’s well-documented off-label marketing of Provigil and you have negative headlines ahead.
In some ways this is not news. The PI for Provigil — often favored by university students studying for a test — compares Provigil users to cocaine-addicted monkeys (emphasis added):
In addition to its wakefulness-promoting effect and increased locomotor activity in animals, in humans, PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine.
Cephalon archly refers to those monkeys in its press release:
… we believe that the potential risk of abuse and dependence is accurately reflected in the product labeling.
Before we get too carried away, first note that the NIDA study observed only 10 men. Ten. That’s all. And docs aren’t exactly screaming for the pill to be withdrawn. If you read this quote carefully, it’s not exactly alarmist:
“This drug does seem to show properties that it can be habit-forming,” said Dr. Richard A. Friedman, director of the Psychopharmacology Clinic at Weill Cornell Medical College in New York City. “This is the first human study that shows that it does cause the release of dopamine, which is a hallmark of drugs of addiction. This is a little bit of an early warning that this drug may not be free of habit-forming properties.”
Nonetheless, a non-scientific sampling of anecdotal pop-culture evidence suggests that people who use Provigil enjoy it a bit more than they should. (Comparison: Ask a cigarette smoker if they feel “addicted.” They don’t, even though they are. That is what’s so weird about it.) Here’s some examples from Provigil users. You be the judge:
> I started taking Hydrocodone, Oxycodone, Morphine, Hydromorphine, whatever I could for the pain. I found that it not only dulled the pain, it cut through this head fog. After a few years of being sick of pain, I gave up on normal physicians and headed to the Chiropractor. Four months later, the pain was gone. It may come back one or two days every month, but not the every day pain I had before. Only thing was, I was hooked on Painkillers and they shot through the head fog like a laser.
One fateful day a coworker of mine gave me a 200mg Provigil tablet she received as a sample. The Provigil did more than cut through my head fog, it made me the person I used to be. With that knowledge and some professional help I got off the narcotics.
Five years later, I’m still taking Provigil and I can’t believe how it saved me. … Some days it’s 200mg, some days I need 1200mg. I realize this is not a good thing.
> The drug is not chemically addictive, from everything I have read, however… I am starting to believe that it will be tougher to go without it than with it. This is not a bad thing, because if I could, I’d probably stay on this drug. The problem lies in that I am starting to think about how many pills I have left, how much they cost, etc…
> Provigil reminds me of cocaine. Checking the Physicians’ Desk Reference, I learn that when Provigil was given to monkeys who were already trained to self-administer coke, they happily inhaled Provigil, not realizing the difference, a behavior that is called “reinforcing.” I can see how this could get addictive.
The rush feels like an eight-year-old’s first downhill slide on the log flume ride at an amusement park — fast, cold and just a little scary. Am I going to miss it? Maybe. But this shit isn’t good for me.
- See previous BNET coverage of Cephalon and Provigil:
- List of 56 Drugs That Should Not Be Mixed With Viagra Contains Some Surprises
- Cephalon: Damn the Torpedoes! We’re Raising Prices!
- “Pain Is Pain”: Cephalon’s Marketing Comes Under DOJ Control
- Behind Cephalon’s Numbers: a Big Cancer Bet and Signs of Skepticism
- Insomnia Pill Makers Go After Elderly With New ‘Fear of Falling’
- FTC accuses Cephalon over Provigil in patent case
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
BNET User Analysis