Is the 'Awake Pill' the Real Deal?

In our fast-paced, 24/7 world, with round-the-clock jobs and nonstop interruptions, the average American gets less than seven hours of sleep a night, and millions get less than six.

That's why all sleep experts agree that, as Dr. Charles Czeisler of Boston's Brigham and Women's Hospital puts it, "we are an incredibly sleepy nation."

So it's not surprising that the sales of Provigil -- the first prescription drug to treat excessive sleepiness -- are exploding.

The drug brought in $800 million last year. Financial analyst Eric Schmidt of Cowen and Co. says, at least for Wall Street, this so-called "awake pill" is a dream, because the market of sleepy people is enormous.

"You're talking a Starbucks type of opportunity," he said. "The growth on this franchise is substantial. It's growing at about 30 [percent] to 40 percent annually, so this is a big drug already and it's getting bigger."

Watch the story on "20/20: Promises, Promises" Friday at 10 p.m. ET

"20/20" and ABC's chief medical correspondent Dr. Tim Johnson set out to discover whether the "awake pill" was really the wonder drug for sleepy America, or whether it was an empty promise, where profits, not patients, were the bottom line.

Off-Label Use

The Food and Drug Administration approved Provigil to treat sleepiness in only three sleep disorders: shift-work syndrome, narcolepsy and sleep apnea.

At least half -- and some say as much as 90 percent -- of Provigil's sales are for off-label use, though, or conditions not approved by the FDA.

"From a financial standpoint, we're really not that concerned with off-label use," Schmidt said. "To us, it's all about sales, and whether they come from an on-label or off-label indication, it's a dollar to [the maker of Provigil] Cephalon's top, and hopefully, bottom line."

But Dr. Jerome Kassirer, author of "On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health," says it's time for drug companies to stop treating health care like it's just another business.

"This is medicine. This is not refrigerators. This is not cars," he said. "This is a profession in which we're taking care of sick people who trust us."

It's illegal for Cephalon to directly advertise off-label use of Provigil, but Kassirer says Cephalon indirectly creates off-label markets for its drug by funding continuing medical education, where doctors get paid to describe Provigil for possible off-label uses.

He showed "20/20" a journal from 2003 sponsored by Cephalon. The journal, called the Primary Care Companion, is a supplement to a well-known journal, The Journal of Clinical Psychiatry.

"It turns out that the people who write those articles have a relationship with Cephalon," Kassirer said.

'Not Real Science'?

Cephalon declined "20/20's" request for an interview about off-label use, but in fact, all seven lead authors of the journal got money from Cephalon as consultants, speakers or researchers. And these articles do not go through rigorous outside review as in a peer-reviewed journal.

Kassirer, who was editor in chief of the New England Journal of Medicine, says this is an important distinction.

"[These articles] would never make it into a really respected medical journal because it's not real science," he said. "I would say that it's a shabby marketing device for the drug by the company."

The marketing seems to be working.

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