NEW YORK (Reuters Health) - If you sleep less than six hours a night, you’re increasing your risk of developing or dying from heart disease by 48 percent. At least, that’s what U.S.-based pharmaceutical giant Abbott would have 1.2 billion people in India believe.
But doctors say the grim message, which appeared in a newspaper ad in India earlier this year, is baseless.
In fact, they worry Abbott’s marketing campaign may be the bigger threat, scaring healthy people into buying potentially harmful sleeping pills they don’t need -- such as the company’s own drug Zolfresh.
“They are implying that taking sleeping pills may help you live longer, whereas the data shows that taking sleeping pills is associated with increased mortality,” said Dr. Daniel F. Kripke, a psychiatrist at the University of California, San Diego.
Industry insiders say the ad points to a bigger problem: According to Benjamin England, an attorney formerly with the U.S. Food and Drug Administration (FDA), drugmakers have lower standards for how they operate in emerging markets like India and China, where government oversight is poor.
“You already feel like you are in the Wild West,” said England, founder of the international consulting firm FDAImports.com. “There is not likely to be anybody who is going to take them to task.”
“If there is nobody paying that much attention to what people are saying about the product, then they’ll push the envelope and say things they would not have gotten away with here,” he told Reuters Health.
And it doesn’t matter that Abbott refrains from mentioning drugs directly, which would have been illegal in India, said another lawyer formerly with the FDA.
“I would argue that if the company making the claim has a sleep product for sale in India, then this is an implicit ad for the product,” the lawyer, who spoke on condition of anonymity, told Reuters Health.
“In the U.S., companies cannot put out a scare notice without substantiation simply because they do not mention their product in the communication.”
CREATING A NEW MARKET
With soaring incomes, expanding insurance coverage and more and more chronic disease, India has become a big draw for global drugmakers. According to one McKinsey report from last year, the country’s drug market will be worth $55 billion by 2020.
Promoting sleeping pills, a staple of Western medicine, is one way to tap into that potential. Last year U.S. doctors prescribed the drugs nearly 60 million times, with sales exceeding $1.9 billion, according to the research firm IMS Health.
In India, a pack of zolpidem -- the generic form of Abbott’s Zolfresh -- sells for just a couple of dollars. Despite the low price, getting just a small fraction of the large population to buy sleeping pills could mean a sizable profit for drugmakers.
“Insomnia is an area where you will find a huge untapped market,” said Ram Bala, a marketing expert at the Indian School of Business in Hyderabad, who has consulted for companies like Johnson & Johnson and AstraZeneca.
He said drugmakers appear to be stepping up their efforts to win over emerging markets, although it’s an uphill battle as many Indians still prefer herbal remedies or are largely unaware of modern medicine.
“There is a lot of public resistance to treating insomnia, because they don’t think it is such an important condition,” Bala told Reuters Health. “If you bombard them with enough information about insomnia, maybe they may at some point decide, ‘Hey, you know what, there are so many people telling me that insomnia is important, maybe I should go to the doctor and check it out.’”
Indeed, Abbott’s ad encourages readers to see their doctor if they can tick off just one of 10 statements, including “I feel sleepy during the day” and “I have a feeling that my sleep is unrefreshing.”
“This is so dramatic and ridiculous,” said Dr. Adriane Fugh-Berman of Georgetown University in Washington, D.C., who runs PharmedOut, a think tank that studies drugmakers’ influence on prescribing.
“It is really advertising, but it is disguised as education,” she told Reuters Health. “Industry calls it disease awareness, those of us who are public health advocates call it disease-mongering -- making people believe that they are sick when they are normal.”
Abbott declined to discuss the purpose of its campaign.
But McKinsey’s India report bolsters Fugh-Berman’s point: “The acceptability of modern medicine and newer therapies will increase due to aggressive market creation by players,” it notes. “Investments in increasing patient awareness and education will impact diagnosis and treatment levels ... In addition, patients will show greater propensity to self-medicate.”
Of course, Western medicines like antibiotics and vaccines have helped countless people across the globe. But in the case of Abbott’s sleeping pills, doctors say the company has gone too far.
In the ad, a smiling Bollywood actress is seen standing next to the words, “Hard Work Never Kills. Lack of Sleep Can.”
It continues, “Research shows that sleeping less than 6 hours at night leads to 48% increase in developing or dying from heart disease.”
Dr. Francesco Cappuccio, whose research Abbott cites, did not answer requests for comments. But his work, like other research, only demonstrates an association -- not that a lack of shuteye is at the root of heart problems.
“They can’t make any claims about the cause,” said Dr. Ana C. Krieger, who directs the Center for Sleep Medicine at Weill Cornell Medical College in New York. “We don’t know if people who sleep four to five hours are environmentally stressed because they work multiple jobs, and then get anxiety and insomnia, or because they are sicker to begin with.”
This may seem like a technical nuance, but it makes all the difference.
“A patient that comes to the office, for instance, saying, ‘I have insomnia and I need my Ambien so I don’t die of heart disease’ -- that just doesn’t fly, we can’t justify that,” Krieger told Reuters Health. “It’s really an extrapolation, which can be kind of dangerous because there are side effects for any medication that we give to people.”
Those side effects include sleepwalking -- risking falls and other accidents -- as well as impaired memory and driving skills.
According to the FDA, the drugs may also cause bizarre behaviors like “sleep-cooking” and “sleep-driving.” The latter rose to national attention in 2006, when then-Representative Patrick Kennedy crashed his car into a barricade on Capitol Hill in the middle of the night.
Kennedy had been taking Sanofi’s Ambien, the same chemical that Abbott sells as Zolfresh in India, as well as an anti-nausea pill that also acts as a sedative.
Krieger said she does prescribe sleeping pills to a few of her patients, but only for short periods of time and when changing their behavior doesn’t help.
“We want people to naturally increase their sleep,” she explained. “We don’t know if an unnatural sleep, like what the medication would do, would really be beneficial for them.”
In fact, people taking sleeping pills turn out to have a higher risk of death than those not on the drugs, even after taking into account other diseases they might have.
While that doesn’t prove the medications kill people, the science hints at it, said UCSD’s Kripke, a long-term critic of sleeping pills.
“The use of sleeping pills, including zolpidem, is associated with higher mortality, and there are 18 studies that show that,” he told Reuters Health.
And the extra rest patients get from the medications, recorded through brainwaves and eye movements and other objective tools, is modest at best. Pooling the available research, one 2007 study estimated zolpidem and similar drugs add just 11 minutes of total sleep time per night.
REGULATION ON THE BACKBURNER
Abbott’s ad includes a link to a website showing a picture of Zolfresh, despite the fact that direct-to-consumer advertising is illegal in India.
The company would not discuss its marketing activities over the phone and declined to comment on its claims.
“Abbott and other health care companies support disease awareness education programs for health conditions where there is an unmet need and where awareness about these conditions is low,” spokesman Scott Davies said in an emailed statement.
He noted that the campaigns “commonly incorporate education on lifestyle factors such as diet, stress and exercise,” although there was no such information in the ad that Reuters Health found.
The firm also said it follows the local regulations wherever it runs campaigns.
However, not even the FDA regulates what drugmakers can and cannot say in the name of disease awareness. And in emerging markets like China and India, experts say marketing claims are unlikely to be put under the microscope.
“Only in the United States and in more developed regulatory markets do we have the privilege to worry about what you said,” FDAImports.com’s England told Reuters Health. “In China, they are like, I don’t care what you said, just don’t sell something that has melamine in it!”
England would not comment on the legality of Abbott’s marketing, but noted that the ad is clearly meant to promote the company’s sleeping pills.
“This is just the beginning of the marketing,” he said. “It’s the door opener.”
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