Thursday, November 22, 2007

Big Pharma and the Big Sleep racket

Snippetts from a interesting and extended article in the NY times. Our interest is in another angle by which people around the world get fleeced by big bad pharma. Of course, the article examines other aspects of the Sleep Industry, including mattresses, marketing, and such.

Compared to how most people sleep, or have slept through history, we never had it so good. Is this another case of "the better off people are, the more they complain?"

A sleep boom, or as Forbes put it last year, “a sleep racket,” is under way. Business 2.0 estimates American “sleeponomics” to be worth $20 billion a year, which includes everything from the more than 1,000 accredited sleep clinics (some of them at spas) conducting overnight tests for disorders like apnea, to countless over-the-counter and herbal sleep aids, to how-to books and sleep-encouraging gadgets and talismans. Zia Sleep Sanctuary, a first of its kind luxury sleep store that I visited in Eden Prairie, Minn., carries “light-therapy” visors, the Zen Alarm Clock, the Mombasa Majesty mosquito net and a $600 pair of noise-canceling earplugs as well as 16 varieties of mattresses and 30 different pillows.

Prescription sleeping pills have been the most obvious beneficiary. Forty-nine million prescriptions were written last year, up 53 percent from five years ago, according to IMS Health, a health-care information company. It is now a $3.7 billion business, more than doubling since 2003. At $3 or $4 per pill, their success indicates not only that we have an increasingly urgent craving for sleep but also that many of us have apparently forgotten how to do it altogether — quite a feat for any mammal.

[...]

Even the most comfortable mattress can only create a place for sleep, not manufacture it directly. But a sleeping pill puts us down — and under circumstances when we’re unable to do it ourselves. Bils told me: “The sleeping pill is an easy path. It promotes sleep over all the rules you break.” In trying to deride his competition, he spelled out its greatest advantage.

Pharmaceutical companies realize they are selling a reassuring guarantee. “Does your restless mind keep you from sleeping?” asks one Lunesta commercial, while the green moth floats in front of a tossing man. Suddenly, like a hypnotist’s watch, it dispatches him into a deep slumber and flies on to lull even the stern, stone visages of Mount Rushmore to sleep. A couple in a commercial for Ambien CR, meanwhile, lie absolutely motionless all night until the darkness around them fades to daylight.

Last year the industry spent more than $600 million on advertising, helping the newest generation of pills, the so-called “Z drugs,” destigmatize sleeping-pill use
.
The nation’s most popular, Ambien and its extended-release counterpart Ambien CR, accounted for 60 percent of all sleep-aid prescriptions last year according to IMS Health, for $2.8 billion in sales. Surely great numbers of Americans are experiencing the kind of satisfying knockouts depicted in the commercials.

Yet, as a very infrequent but contented user of both Lunesta and Ambien myself, I was startled to read efficacy trials for those drugs submitted to the F.D.A. In one six-week trial, for example, people taking Ambien every night fell asleep, on average, only 23 minutes faster than those taking the placebo. They spent 88 percent of their time in bed asleep, as opposed to 82 percent. Given that their objectively measured improvements are frequently this meager, why do sleeping pills create incommensurate feelings of having slept so well?

A popular theory is that one of the pill’s side-effects is actually contributing to their success. Most sleeping pills are known to block the formation of memories during their use, creating amnesia. This is why people who endure freaky side-effects — so-called “complex sleep-related behaviors” like getting into a car and driving or ravenously eating, all while asleep — don’t remember those events. Yet this amnesia could be quite beneficial, suggests Michael Bonnet, a professor of neurology at Wright State University Boonshoft School of Medicine in Dayton, Ohio. “How do you know you slept last night?” Bonnet asked me. A night of lousy, interrupted sleep, he points out, is easy to remember. “It’s full of memories, noise and pain, and heat and rolling around and obtrusive thoughts and worries — all of these various stimuli.” And we may continue to register such things even while asleep, making sleep vaguely unrefreshing. But a good night of sleep, Bonnet went on to say, “is always the antithesis to all those things, which is oblivion.” A sleeping pill, Bonnet speculates, in addition to encouraging sleep chemically in the brain, also “erases all of these thoughts that we use to define ourselves as being awake. The pill knocks them all out, and the patient says, ‘Hey, I must have been asleep because I don’t remember anything.’ ”

Drug-company representatives and consultants I spoke to confirm that their pills can create this mild form of amnesia but disagree that it contributes any significant benefit.
“That is not my understanding of how Ambien works,” Dario Mirski, a psychiatrist and spokesman for Ambien’s manufacturer, Sanofi-Aventis, told me. It is difficult to find a clinical trial in which Z-drug takers drastically overestimated how long they slept.

Andrew Krystal, a Duke University psychiatrist and consultant to pharmaceutical companies like Sepracor, Lunesta’s manufacturer, acknowledges an apparent discrepancy in studies between small, objectively recorded improvements and the large percentage of subjects who end up feeling that a pill alleviated their insomnia. But because insomnia is complaint-based, he explained to me, an insomniac is cured when he stops complaining. Who’s to say how many more minutes of sleep or fewer awakenings during the night it should take to relieve each individual’s highly subjective dissatisfaction? Many insomniacs don’t show impaired sleep by any objective measure to begin with — but presumably they benefit from sleeping pills, too. So, Krystal asked, what would you expect to see improve? (A 1990 study presents a jarring example: it focused on a group of insomniacs who, when woken up, swore they hadn’t been sleeping. But if given a sleeping pill first, then woken up, they knew they’d been asleep.) He added, “I’m not a person who shares the view that the reason the drugs work is because they’re amnestic.”

Another prevalent theory is that sleeping pills produce a beneficial physiological effect that clinicians don’t realize they should be measuring. The standard battery of brain-wave and other measurements used in sleep labs provide only a “limited picture,” Krystal said. Nevertheless, several researchers suggested why the amnesia factor isn’t likely to be explained to patients, even as a theory. We tend to see sleep problems as physiological. A treatment that works, even in part, by altering our perception of that problem would seem like “more of a fake,” says Charles Morin, director of the Sleep Research Center at Laval University in Quebec City. Imagine, Morin said, if doctors told their patients: “You keep waking up at night but you just don’t remember it.”

Sleep doctors have criticized sleeping-pill ads for setting up an unattainable expectation of how blissful and easy sleep should be. But the mattress industry operates under that expectation, too, trying vigorously to build a state-of-the-art, NASA-engineered arena on which that idealized, paralytic oblivion can occur. But how did we come to need so much help sleeping in the first place, and how did we come to want, much less expect, the sleep these people are selling?

No comments: