He's Just Being Frank - Pharmaceutical Executive


He's Just Being Frank
Cephalon's boss brought Provigil to market, runs his biotech like a Big Pharma, and mouths off at you-know-who. Now he's going global with plans to corner cancer. The really scary thing is, Baldino, 53, hasn't even peaked.

Pharmaceutical Executive

But it wasn't until the company filed a supplementary new drug application (sNDA) for Provigil in 2002, aiming for a broad "excessive daytime sleepiness" (EDS) label, that mainstream coverage hit high gear, with epic headlines like the Wall Street Journal's "The Quest to Banish Fatigue." Sleep guru David Dinges weighed in, in The New Yorker, calling Provigil "the most tempting drug to come along in decades. It promises to satisfy our relentless desire to control time."

With sales soaring—and 90 percent of scripts off label—the drug attracted an inevitable performance-enhancement buzz. Reporters outdid one another with inflated rhetoric. Provigil was "the next Viagra in lifestyle drugs," a "brain steroid" and "smart pill," and would "free the mind from sleep" the same way that the Pill liberated sex from procreation. That six American track and field stars tested positive for Provigil, which led the US Olympic Committee to ban the drug, didn't help matters. Neither did Baldino's self-confessed preference for using it.

Provigil, as filtered through the media, looked both very good—and very bad. The New York Times finally exhausted the genre in 2004 with a lengthy piece implying that the drug might have prevented the nuclear meltdown at Chernobyl and the Exxon Valdez oil spill, but that it also seemed on the verge of creating a generation of sleepless, soulless, 24/7 workaholics.

Such is the price of being a true breakthrough drug. And price, ironically, may be what has prevented Provigil from becoming—gasp!—the Ultimate Lifestyle Drug: At $7 or $8 a dose and limited reimbursement, Provigil is too costly for most casually interested consumers.

As a consumer with a more than casual interest in any chemical that might pump up my mental muscle, I raised the lifestyle question with Baldino. He immediately put the kibosh on my fantasies of Provigil as a cognitive enhancer. "You're talking about misuse," he said sharply. "I think if you're tired, Provigil will keep you awake. If you're not tired, it's not going to do anything."

But what about the increasing demand by a society obsessed with "more, better, faster"? "I don't see the FDA ever approving a drug for a lifestyle improvement," he said. "And I don't know if I want to sell one. We entered this business to develop drugs for sick people."

I tried again. This time he said, "You know, eight years' experience, millions of patients who use this drug around the world, very few, if anybody, is using it for a lifestyle enhancement. People like to sleep." One look across the table at Corporate Communications, and I knew I could never ask Baldino whether he considered a pharma exec's jet lag a lifestyle enhancement.

A Problem With Authority

Baldino's scruples haven't stopped Cephalon from pursuing the signature strategy of milking its drugs for as many indications as possible. Provigil's 2002 sNDA for EDS would have allowed docs to prescribe liberally for fatigue, consumers to get claims paid, and Cephalon's then-300-strong sales force to pitch to primary-care physicians and internists. Although there was no lack of data backing the application, the FDA balked, okaying only the sleep apnea and shift-work indications. Its advisory panel had voiced concern about overprescribing, and the agency had recently slapped Cephalon with a warning letter for pushing the envelope with its sales detailing. "The labeling doesn't matter," the irrepressible Baldino shot back, telling reporters he planned to up his sales force to 450. "As long as we can legitimately call on GPs and access the population they treat, the sales of the drug will be larger."


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