Americans' growing reliance on prescription drugs to lull themselves to sleep has reignited debate about the role of commercials in influencing the medical choices of patients and doctors.
Use of prescription sleeping pills is up nearly 50% since 2001, and a report released Monday by Consumers Union of United States Inc., publisher of Consumer Reports magazine, attributes at least part of the increase to a surge in direct-to-consumer advertising of such anti-insomnia medications as Ambien and Lunesta.
Critics have long contended that aggressive advertising by drug companies has resulted in rising healthcare costs and overuse of drugs, some of which might have dangerous side effects.
What's different now with the new generation of prescription sleeping pills, critics say, is that their marketing may be inducing people to use medications unnecessarily. For those longing for a good night's sleep, they say, other remedies, like over-the-counter medicines or even changes in habit, might work just as well or better.
"We've always known there are people who suffer from insomnia. But what the advertising has done is make a big noise about a problem that may not have been that big of a problem," said Marvin M. Lipman, a Scarsdale, N.Y., physician and chief medical advisor for Consumers Union. "In a sense, they've helped create the disease."
The drug industry spent more than $4 billion in consumer advertising last year, a fivefold increase in 10 years. The U.S. is among a few countries that allow consumer advertising of prescription drugs. For years, pharmaceutical advertising was directed mainly at doctors and hospitals, but in 1997, the Food and Drug Administration issued guidelines for television advertising that helped spur a boom in drug commercials.
Drug manufacturers say their ads are aimed at educating patients and doctors about diseases and treatments, not necessarily to peddle their medicines.
Chris Benecchi, product manager at Lincolnshire, Ill.-based Takeda Pharmaceuticals North America Inc., maker of sleeping medication Rozerem, said the company went to great lengths to educate doctors about other insomnia remedies. The drug's website lists several of them in a link above the video ad of a sleepless man talking in his kitchen to Abraham Lincoln and a beaver. The ad campaign's tag line: "Your dreams miss you."
"Surveys show [consumer] advertising brings patients into their doctors' offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated," Ken Johnson, senior vice president at industry trade group Pharmaceutical Research & Manufacturers of America, said in a statement Monday. "Ultimately, it is doctors and patients together who should be making decisions on a patient's care, and to do that, they need the best information possible."
Last year, Americans filled 43 million prescriptions for sleeping pills, up from 29 million in 2001. Sanofi-Aventis' Ambien, the bestselling sleeping pill, was the 14th-most prescribed drug in the U.S., according to research firm IMS Health Inc. Ambien, approved in 1992, grew from less than $1 billion in sales in 2001 to more than $2 billion last year.
About 50 million to 70 million Americans suffer from insomnia, according to the National Academy of Sciences' Institute of Medicine, but the causes are not always clear.
Insomnia is not a disease but a set of symptoms mostly triggered by other things such as stress, pain or jet lag. Critics say consumer advertising is most questionable when hawking prescription medications that treat conditions such as insomnia rather than particular ailments.
By heavily promoting drugs that treat symptoms rather than illnesses, some doctors say, companies may be driving patients to seek quick fixes instead of finding a solution. In most cases, doctors say, sleeping pills should be the last resort. But for many insomnia sufferers, that's the first thing they ask for when they enter a doctor's office.
"When you see a commercial with the sun breaking over the hill and curtains opening and people with big grins on their faces and butterflies flying all around, sleeping pills become the treatment of first choice," said Lloyd Van Winkle, a family physician in Castroville, Texas.
By contrast, ads for cholesterol-lowering drugs such as Pfizer Inc.'s Lipitor or AstraZeneca's Crestor are unlikely to drive someone without a cholesterol problem to request a prescription. That's because someone either has high cholesterol or not. Doctors also credit advertising cholesterol-lowering drugs for prompting many people to check their cholesterol levels.
Advertising can also promote use of expensive prescription drugs by otherwise healthy people, critics say. Some users of Pfizer's Viagra and other drugs to treat erectile dysfunction are taking them not out of medical need but to facilitate certain lifestyles.
Doctors are often too busy to argue with patients or to spend much time diagnosing non-life-threatening conditions such as insomnia, medical experts said.
"Doctors have only a few minutes with most of their patients, and they will usually find the path of least resistance, especially if a drug probably won't do much harm and may do some good," said Larry Levitt, a spokesman for Kaiser Family Foundation, which studied the link between advertising and prescription-drug sales. The study found that each additional dollar spent in consumer advertising yielded $4.20 in drug sales.
That adds to the country's healthcare bill, critics say. Americans spend about $190 billion in prescription medicines a year, according to Kaiser. It is only about a tenth of the entire healthcare bill, but it is increasing faster than other categories, such as physician and hospital bills.
According to Consumer Reports, seven doses of Rozerem cost $24 on average. Other sleeping pills were within similar price ranges: $25 for King Pharmaceuticals Inc.'s Sonata and $30 for Sepracor Inc.'s Lunesta.
Some patients swear by the pills. Emily Arms, 43, of Westchester was a new mom and starting as an assistant professor of education at Loyola Marymount University two years ago. After waking twice a night to feed her baby, her body stayed on the clock even after her daughter slept through the night.
She said her doctor suggested cutting caffeine and over-the-counter medicines, to no avail.
Her doctor prescribed Ambien and she used it for almost a year. She noticed no side effects.
"For me, it was a miracle drug," Arms said.
But some doctors caution that any prescription drug carries risks. They point to Merck & Co.'s Vioxx, a once-heavily advertised arthritis pain medicine that was pulled off the market in 2004 after it was linked to heart attacks.
In the case of sleeping aids, there have been reports of memory loss and sleepwalking in Ambien takers.
The Consumer Reports Best Buy Drugs project cautions that the safety and efficacy of the new generation of sleeping aids are still being debated. The study can be found at www.consumerreports.org/health.
Daniel Yi, Los Angeles Times. August 8, 2006
Copyright © 2006 Los Angeles Times. All rights reserved.