Healthy Skepticism Library item: 2269

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

Kerber R.
Doctors criticize sleeping-pill ads
The Boston Globe 2005 Aug 18
http://www.boston.com/business/globe/articles/2005/08/18/doctors_criticize_sleeping_pill_ads/

Keywords:
Lunesta Sepracor DTCA direct-to-consumer advertising

Notes:

Ralph Faggotter’s Comments: This article highlights some of the problems inherent in direct-to-consumer advertising. The advertisemnets are created by advertising companies which haven’t got a clue about medical ethics and neither do they care.
ALL sleeping pills have significant inherent dangers – but you won’t see these getting a mention in DTCA.

Full text:

Doctors criticize sleeping-pill ads
Sepracor’s claims about drug misleading, psychiatrists say

By Ross Kerber, Globe Staff | August 18, 2005

An advertising campaign by Sepracor Inc. is drawing fire from psychiatrists who say the Marlborough company misrepresents its new sleeping pill.

The complaints from several high-profile psychiatrists hinge on language in advertisements for the prescription drug, Lunesta, and illustrate how drug makers and the Food and Drug Administration can expect stiff scrutiny of product claims as the debate over direct-to-consumer advertising heats up.

The company won’t discuss the criticism of it advertisements — which appear in print, on television, and on the Internet — except to say they were reviewed by the FDA before its $60 million campaign was launched this year.

One print ad says Lunesta is ‘‘the first and only prescription sleep aid approved for long-term use.” Similar phrases appear on Sepracor’s website for the drug, lunesta.com, and in television ads. They depict restless people being lulled to sleep by what appears to be a luna moth, which is active at night.

But while Lunesta’s label says the drug is intended to treat insomnia, it does not mention how long the pills can safely be taken. The FDA did not require the label to specify that the drug is for ‘‘short-term” use, as it has for other prescription sleep aids on the market.

University of Pittsburgh psychiatrist Daniel Buysse, who is also a consultant to Sepracor, said that makes the Lunesta advertising ‘‘a little bit misleading.” He believes more long-term studies of sleeping-pill safety is needed.

Gregg Jacobs, a Harvard Medical School assistant professor of psychiatry, said some of the ad claims aren’t backed by a study that helped Sepracor receive FDA approval for the drug this year. The study, in the medical journal Sleep, showed that patients using Lunesta fell asleep about 20 minutes faster than those taking a placebo, but they still took about 45 minutes to dose off, according to the study’s mean average. Insomnia is often defined as failure to fall asleep within 30 minutes.

Jacobs also disputes a TV ad claim that ‘‘Lunesta helps most people sleep all through the night.” As those words are spoken, screen text reads, ‘‘A full night = 8 hours.” The Lunesta website says a study showed ‘‘most people who took Lunesta slept an average of 7-8 hours.” But the Sleep study reported a median sleep time of only about 6 hours, 20 minutes.

‘‘Patients who took this drug did not become normal sleepers,” Jacobs said.

University of California psychiatrist Daniel F. Kripke makes similar criticisms of the drug and how it is advertised. Jacobs and Kripke have said behavioral therapy is preferable to pills for treating insomnia long-term, a hotly debated issue in the field of sleep medicine, and they have previously criticized Sepracor in letters in Sleep. ( for the rst of the article you need to be registered with The Boston Globe website)