Lisa Schwartz, a Dartmouth medical professor, says the main problem with most drug ads is that they exaggerate the benefits of a medicine while minimizing the side effects.
Here, she deconstructs a Lunesta sleeping pill commercial, comparing the ad's narrated and written claims with a 2003 research study conducted on the drug, which was approved by the FDA in 2005.
AD CLAIM: Millions of Americans who once had trouble turning off their restless minds are catching a great night's sleep with Lunesta.
Ads tend to broaden the definition of disease, Schwartz says. They can make healthy viewers wonder if they have a disease, and thus need a drug to cure it. But in clinical trials to test if a drug is effective, "the medical problems are defined by much more stringent terms," she says. In a large 2003 study, Lunesta was tested for effectiveness in adults who clinically had insomnia. That is, they reported sleeping on average less than six and half hours per night and/or took more than 30 minutes to fall asleep over a one-month period.
By offering Lunesta as a solution for "restless minds" at night, however, the ad encourages people to seek a medical explanation and solution for a problem that isn't necessarily medical. "The first, most important treatments (for sleeplessness) are things like increasing exercise, avoiding caffeine, avoiding daytime naps and ... technically, it isn't insomnia until you've had it for 30 days."
AD CLAIM: Lunesta helps most people sleep all through the night. A full night = 8 hours.
Sepracor, the maker of Lunesta, says it bases its ad claims on a 2004 sleep-lab study, led by Dr. Gary Zammit of Columbia University and sponsored by Sepracor. Sepracor also paid for a larger 2003 study, led by Dr. Andrew Krystal of Duke. Both studies were considered by the FDA in its decision to approve Lunesta in 2005.
In the smaller 2004 study, 308 patients were given Lunesta or a placebo for 44 days, three nights of which they were monitored in a sleep lab. Sixty-eight percent of Lunesta patients slept on average for seven hours or more, vs. 37 percent of the placebo group. Sepracor says such a sleep-lab study is a much more controlled way to measure sleep.
But Schwartz says the 2003 study, in which 788 patients took either Lunesta or a sugar pill every night for six months, is bigger. In it, Lunesta patients only slept 37 minutes longer – an average of six hours and 22 minutes – than those taking a sugar pill, who on average slept five hours and 45 minutes.
AD CLAIM: And works quickly, so take it right before bed.
The ad gives the impression that Lunesta is fast-acting, Schwartz says. But in the larger 2003 study, Lunesta users fell asleep only 15 minutes faster than those taking a sugar pill. On average, it took Lunesta users 30 minutes to fall asleep vs. 45 minutes for those taking a sugar pill.
AD CLAIM: Lunesta is... approved for long-term use.
Patients may have a different idea of what "long-term use" means. Clinical trials on many sleep medicines, including Lunesta, have only lasted for six months, Schwartz says. "I don't think when people hear long-term use, they're thinking that it was studied for only six months," she says.
AD CLAIM: Most sleep medicines carry some risk of dependency. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
The larger 2003 study found that those taking the pill had more side effects than those taking a sugar pill. About 20 percent more said they had an unpleasant taste in their mouth; 7 percent more said they experienced dizziness; 5 percent more reported dry mouth; 5 percent more reported nausea. And what Schwartz says she finds most interesting about the side effects is that 6 percent more of Lunesta patients reported feeling sleepy the next day. Granted, it's not a huge number, says Schwartz, but "the reason that people are interested in sleeping better, is to feel better the next day."
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