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Do Sleepy Shift Workers Need Cephalon’s Pick-Me-Up Pill?

Cephalon’s pricey Nuvigil competes with coffee—and has a lot more side effects

By

Michelle Cortez

August 11, 2011, 10:00 PM EDT

Roger Greer, a 45-year-old water treatment plant worker from Coatesville, Pa., was surfing the Internet when he discovered that his constant fatigue had a medical name: shift work sleep disorder. The starting time of Greer’s job rotates weekly, leaving him sleepy on the job and ornery at home. The website had an ad suggesting he ask his doctor if an alertness pill made by Cephalon, called Nuvigil, is right for him. A year later, “I don’t have those sleepy moments,” says Greer. “Now at 3 in the morning, the absolute worst time for anybody, I no longer have the fear of missing something here at work.”

Workers like Greer are prime targets for a Cephalon marketing campaign—on the Internet and radio, in doctors’ offices, and at community meetings—that aims to educate America’s 15 million shift workers about the disorder. For the drugmaker, it’s a way to build brand recognition and sales for Nuvigil, a newer version of its blockbuster narcolepsy drug, Provigil, which loses patent protection next year. But the campaign has sparked concern by some doctors about whether a pharmaceutical solution is the best way to stay alert on the job. Nuvigil hasn’t been proved more effective than coffee, is classified as possibly addictive, and carries side effects that can be fatal, according to the drug’s label.

“We as a society rely too much on pills and medication,” says Robert Basner, director of Columbia University’s Cardiopulmonary Sleep and Ventilatory Disorders Center. “That’s not always the best approach. Caffeine is a very good wake-promoting agent, and it’s a lot cheaper.”

Cephalon is spending $3.6 million on radio ads pitching Nuvigil, plus about $490,000 annually on the Internet effort and informational booths at community events. That’s a small percentage of the $1.1 billion in annual sales that will be at risk after Provigil goes off-patent. Israel’s Teva Pharmaceutical Industries agreed in May to buy Cephalon for $6.2 billion in part because of Nuvigil’s prospects. The drug’s sales are growing at a 50 percent annual rate.

Bethany Young, a 27-year-old Teas Valley (W. Va.) medical technologist, was given free samples of Nuvigil after complaining to her new doctor that she couldn’t focus during her 7 p.m. to 7 a.m. hospital shifts. During six years of night work, she struggled to get out of bed, gained 60 pounds, and developed hypothyroidism. At first the drug made her feel euphoric. Soon that effect began to melt away after an hour, replaced by feelings of anxiety and stress, she says, and when she tried to stop using it after a few months, she initially couldn’t. “I was getting hooked on it. I couldn’t quit. This drug is the devil. It was for me, anyway.”

Cephalon says that because medications like Nuvigil “may lead to limited physical or psychological dependence, we encourage physicians to follow patients closely.” The company also reports plenty of side effects that can accompany Nuvigil use, ranging from headache, nausea, and skin rashes to hallucinations and depression.

Cephalon’s media campaign is its first to widely trumpet alertness pills by stressing the recognition of shift work disorder by doctors and sleep experts, who estimate the malady may affect one in four shift workers. Although Cephalon doesn’t claim Nuvigil works better than other approaches, the company says that between 2007 and 2009 it studied 359 shift workers for six weeks and found 77 percent of those who took Nuvigil said they were more alert for the last part of their shift and the drive home, compared with 57 percent given a placebo.

“What we are doing is educating doctors and the public about this disorder,” says Charles Altman, Cephalon’s senior medical director. “Doctors often don’t ask patients what hours they work. In our 24/7 society, it doesn’t matter if you are a nurse or an information technology worker or in finance, we are called upon more and more to work odd hours that are against the grain of the way our internal clock works.”

Critics, however, say the diagnosis of shift work sleep disorder is so broad that people with irregular hours who have trouble staying awake at night can get the pills even without trying non-drug strategies first. “It’s not a diagnosis that is crisp and determined by clear-cut, objective data, which opens it up to criticism,” says Lois Krahn, chair of psychiatry at the Mayo Clinic in Scottsdale, Ariz. “When [patients] have done everything they can to get more sleep, and they still have trouble staying awake, that’s when drug therapy comes in.”

Besides the ad push, Cephalon is using pricing to lure users. At $12 a pill, Nuvigil sells for $5 less than its older sibling. Cephalon also is providing consumers with coupons for free trials and help with insurance co-pays to spur use of the newer drug. The strategy is paying off, with the number of Nuvigil prescriptions written in late June almost equaling those for Provigil. “It’s growing very nicely,” says Cephlon’s Altman.

Provigil was first approved for sale in 1998 as a treatment for narcolepsy, a rare condition in which patients unexpectedly fall asleep in the middle of the day. Provigil kept them awake, without the dangers of stimulants. Sales, which surged as people without the condition also used it, topped $500 million annually after the pill won clearance for shift work disorder in 2004. Nuvigil was introduced in 2009, two years after it was approved for narcolepsy, shift work disorder, and sleep apnea. It had sales of $186 million in 2010, and analysts say it could hit $577 million in 2015.

Sleep experts say Cephalon’s radio ads in 21 big U.S. cities may educate patients with symptoms that employers and family members often don’t understand. Still, doctors say simply handing struggling shift workers a prescription would be a mistake without trying lifestyle changes, such as strategic naps or wearing sunglasses on the drive home to limit exposure to light. Explains Douglas Moul, staff physician at the Cleveland Clinic Sleep Center: “We want to treat the real condition, rather than just papering over the symptoms with a medication that can just keep people awake longer.”

BOTTOM LINE -

The bottom line: Sales of Cephalon’s shift work disorder drug, Nuvigil, are growing 50 percent annually. Critics say the pills may be overprescribed.

Read the article and answer the following questions in detail:

1) Should employers consider providing Nuvigil to their shift workers?

2) What are the ethical implications of producing such a drug?

3) Are there ethical issues facing the employer? The employee? If so, please explain.