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Ilena Rose
Posted: Sun Jan 14, 2007 9:51 pm
Guest
May 9, 2006
Op-Ed Contributor
Generic Smear Campaign
By DANIEL CARLAT
Newburyport, Mass.

THAT pharmaceutical companies pay doctors to say good things about
their drugs is no longer newsworthy. Two former editors of The New
England Journal of Medicine, Jerome P. Kassirer and Marcia Angell,
have documented the drug industry's use of doctors to promote new
medicines through professional articles and at medical conferences.

But in a move that may astonish even the most jaded critics of
ethically challenged pharmaceutical marketing, makers of sleeping
pills are now paying doctors to publish bad things about competing
drugs.

The market for sleeping pills is huge — 42 million prescriptions were
filled last year — and it is more competitive than ever, thanks to the
recent introduction of Sepracor's Lunesta (the one with the butterfly
commercials), Sanofi-Aventis's Ambien CR (a controlled-release version
of Ambien) and Takeda Pharmaceuticals' Rozerem. Ads have made most of
these drugs household names. Yet many people have never heard of one
of the most widely prescribed hypnotics in the United States:
trazodone.

First approved by the Food and Drug Administration 25 years ago,
trazodone is categorized as an antidepressant. Nonetheless,
psychiatrists prescribe it off label to treat insomnia, because it
works so well. Trazodone carries no risk of addiction; its half-life
is long enough to keep patients asleep all night; it has a long safety
record; and it is cheap, costing as little as 10 cents a pill. (Ambien
and Lunesta can cost $3 a pill or more.) And in the only sizable study
to compare trazodone with Ambien as a sleep aid, the two drugs
performed equally well.

But each time a psychiatrist prescribes trazodone, a potential sale of
Lunesta or Ambien is lost. No doubt that is why, in the past few
years, several articles have been published in professional journals
that can only be described as trazodone-bashing. With titles like "The
Use of Trazodone as a Hypnotic: A Critical Review" (published in The
Journal of Clinical Psychiatry), these articles purport to present
balanced reviews of the scientific literature on sleeping pills. But
the authors, psychiatrists with university affiliations, have been
paid by Sepracor, Sanofi-Aventis or Takeda, the companies that stand
to gain from trazodone's downfall.

A disclosure statement at the top of one such paper, "A Review of the
Evidence for the Efficacy and Safety of Trazodone in Insomnia," also
in The Journal of Clinical Psychiatry, states that Sepracor "assisted
in the preparation" of the article, and paid the author a fee for "the
services he provided in support of the development" of the manuscript.
A careful reading of these articles reveals a pattern of rhetorical
techniques: a minimization of trazodone's advantages and an emphasis
on its negative qualities.

Trazodone is criticized as lacking high-quality research data on its
ability to help people sleep. What is left unmentioned is that because
trazodone is no longer patented, no pharmaceutical company stands to
profit from doing such research.

The authors also dust off older studies highlighting side effects from
trazodone, like cardiac arrhythmias or priapism (prolonged painful
erections). But these side effects are extremely rare: priapism has
been found to occur in one in 5,000 men who take the drug, and the
incidence of cardiac arrythmias is even lower.

Case reports of such side effects inevitably surface when a drug has
been on the market for 25 years. In the case of Ambien, the oldest of
the newer drugs, we are already seeing a flurry of reports of problems
like drug abuse, sleepwalking, night eating and car accidents that may
be associated with its use.

The way to discourage this practice of negative marketing disguised as
legitimate scientific commentary is to mandate fuller disclosure of
links between drug companies and authors. Several states now insist
that drug makers report the gifts they give doctors.

These same companies should be required to disclose the exact nature
of a doctor's involvement in preparing a sponsored article, as well as
the dollar amount of his or her fee. I suspect it would be the rare
doctor who would want such information to come to light.

Daniel Carlat, a professor at Tufts Medical School, is the editor in
chief of The Carlat Psychiatry Report.

~~~~~~~~~~~~

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