Healthy Skepticism Library item: 5113

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Henderson D.
The big sleep : Pfizer pushes into the multibillion-dollarmarket to treat insomnia as Americans' demand for help steadily increases
Boston Globe 2006 Jun 11
http://www.boston.com/business/healthcare/articles/2006/06/11/the_big_sleep/

Notes:

Ralph Faggotter’s Comments:

“…Americans’ demand for help steadily increases “

The demand is stimulated but advertising.

The advertisements however fail to warn how easy it is to get addicted to these drugs- and once addicted to them, it is a nightmare trying to get off them.

Perhaps if there was truth in advertising, the demand would not be so great!

Full text:

The big sleep
Pfizer pushes into the multibillion-dollarmarket to treat insomnia as Americans’ demand for help steadily increases
By Diedtra Henderson, Globe Staff | June 11, 2006

Pfizer Inc. , maker of top-selling, cholesterol-lowering Lipitor, wants to tackle another potentially lucrative chronic condition: sleepless nights.

Indiplon , a new prescription sleep aid that would be co-marketed by Pfizer , could be the next entrant into the multibillion-dollar battle to help Americans who can’t fall asleep, can’t remain asleep, or wake too early.

That could be bad news for Sepracor Inc. , a Marlborough company that in just over a year transformed its new pill Lunesta , into a multimillion-dollar revenue generator. Analysts say Sepracor has the most to lose should Pfizer, the world’s largest drug maker, apply its marketing might to get into the crowded insomnia treatment field.

So, why does David Southwell , Sepracor’s executive vice president , sound so confident?

``I do not expect competition from Indiplon any time soon — if ever,” Southwell said in an interview last week.

That’s because the Food and Drug Administration last month declined to approve a version of the pill, a 15-milligram capsule, that would have kept consumers asleep all night — and that would have tapped into the most lucrative segment of the market. The agency told Pfizer and partner Neurocrine Biosciences Inc. that it was willing to approve lower-dose formulations that can help people drop off to sleep.

The battle to provide millions of Americans with a restful night’s sleep has become brutal. Aggressive advertising campaigns by Sepracor have turned Lunesta into the nation’s number two prescription sleeping pill. Meanwhile, tales of mysterious nighttime eating binges and sleepwalking episodes have been linked to the market leader, Ambien, most notably Representative Patrick Kennedy , Democrat of Rhode Island , who blamed erratic driving on prescription drugs that included Ambien.

How badly do drug companies crave market share? A recent New York Times opinion piece accused companies of branded products with sullying the reputation of trazodone , a generic drug prescribed as a sleep remedy that gnawed at their profit margin.

There is a simple reason for the fierce competition: Money.

``Really, there aren’t that many differences, especially if you look at the differences between these newer sleeping pills, Indiplon vs. Ambien vs. Lunesta,” said Dr. Daniel J. Carlat , author of the opinion piece ``Generic Smear Campaign” and assistant professor at Tufts University School of Medicine. ``And there is a huge amount of money to be made.”

Up to 70 million Americans suffer from sleeping problems, according to the Institute of Medicine , part of the National Academies . And up to 40 percent of adult Americans experience some insomnia symptoms each year, says the National Institutes of Health . Roughly 10 percent of Americans are chronically sleep-deprived and have a higher chance of suffering from such ailments as heart disease and diabetes . Sleep gurus attempt to determine the root cause of the sleeplessness, be it emotional or medical problems, said Dr. Lawrence J. Epstein , regional medical director for Sleep HealthCenters in Massachusetts .

But increasingly — and with drug industry encouragement — Americans reach for pills to remedy their sleepless nights, driving the insomnia drug market to $2.8 billion in 2005 , up 31 percent , according to IMS Health , a healthcare information company.

``They no longer think of [insomnia] as something they have to put up with,” said Epstein, also president of the American Academy of Sleep Medicine . ``The demand has increased for help with sleep. If the demand is up, then people are going to move to provide the supply.”

There may still be a place for the 5-milligram and 10-milligram doses of Indiplon that the FDA is willing to approve. Doctors see patients who wake at 3 a.m. and need a little help returning to sleep, without grogginess lingering in the daytime.

But demand for that kind of remedy has been low. A King Pharmaceuticals Inc. drug called Sonata helps people fall back asleep, but it has garnered only 4 percent of the market and recorded just $118 million in sales last year, according to IMS Health.

Barbara Ryan , a Deutsche Bank Securities Inc. analyst, predicted Pfizer would walk away from Indiplon.

``The environment will become even more challenging for subsequent entrants that lack distinctive features,” Ryan wrote in a research note.

Pfizer spokeswoman Betsy Raymond said last week the company ``has made no decision” on Indiplon.

Reports of troubling side effects still haunt Ambien, an insomnia treatment manufactured by Sanofi-Aventis , the world’s third- largest pharmaceutical company.

Sedative hypnotic drugs such Ambien work on receptors in the brain that, depending on the subunit activated, can help anxious patients feel relaxed, can ease convulsions, and can help people seeking sleep feel a calming effect. But users can also experience forgetfulness during a nearly two-hour window after taking Ambien, a sleep disorders doctor in Minneapolis said.

``That window from when you take it to 1 1/2 hours is a very vulnerable time,” said Dr. Michel A. Cramer-Bornemann , staff physician at the Minnesota Regional Sleep Disorder Center .

The center began seeing a new type of sleepwalking reported by people taking Ambien. Patients had no memory of what they did while sleepwalking, such as driving or compulsive eating, Cramer-Bornemann said.

Kennedy, as it turned out, reported the same problem before checking into rehabilitation.

Sanofi launched advertising defending Ambien safety, noting that sleepwalking and sleep-related eating already are mentioned on the drug’s label as possible rare side effects.

Sepracor’s Southwell won’t say whether the company remains willing to spend heavily to promote Lunesta. The company launched the drug in April 2005 with the help of a large salesforce and a flurry of advertising. In one month alone, Sepracor spent $43 million sending its luminescent butterfly flitting across television screens and print ads, according to Nielsen Monitor-Plus .

In the first three months of 2006 , Sepracor spent $107.6 million on such ads. That compares with $60.3 million Sanofi spent advertising Ambien CR , its extended release tablet. The other, shorter-acting version of Ambien helped establish the market.

Because the sleep market is ``very consumer driven,” such marketing matters more, said Les Funtleyder, a healthcare strategist at Miller Tabak + Co. ``There is something to be said about getting mind share and getting public opinion or physician opinion.”

From experience in his own practice, Carlat, the Tufts’ assistant clinical professor of psychiatry , said that rings true.

``People come in all the time and they tell me that they want to try that new sleeping pill with the butterfly on it,” Carlat said. He refers them to older, cheaper insomnia treatments that he says work just as well.

Diedtra Henderson can be reached at dhenderson@globe.com.

© Copyright 2006 The New York Times Company