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Wyeth Paid Writers to Promote Hormone Therapy: Study
By Julie Steenhuysen
CHICAGO (Reuters) Sep 08 - Drugmaker Wyeth used
ghostwriters to play up the benefits and downplay the harm of hormone
replacement therapy in articles published in medical journals, a U.S. researcher
said on Tuesday.
Dr. Adriane Fugh-Berman of Georgetown University
Medical Center in Washington, D.C. analyzed ghostwritten reviews and
commentaries published in medical journals and journal supplements, along with
corporate documents revealed in litigation.
She said Wyeth, now owned by Pfizer, paid a medical
communication company called DesignWrite to write 20 review articles about the
drug at $20,000 each. They said the company was expected to promote unauthorized
use of the drug to prevent dementia, Parkinson's disease, vision troubles and
even wrinkles.
Dr. Fugh-Berman asserts that clinical trial reports
were sometimes modified for marketing purposes. "For example," she said, "Wyeth
apparently wanted the metabolic effects of a Premarin/trimegestone combination
removed from the lead publication on this product. A 2003 DesignWrite email to
James H. Pickar, a physician employed by Wyeth, noted the marketing team's
concerns: '... it is highly desirable for them to not have the metabolic data
included in the lead paper, as this would cause labeling problems, making the
lead paper unusable for promotional purposes.'"
Dr. Fugh-Berman acknowledges that she was a paid
expert witness for plaintiffs in hormone therapy litigation.
Pfizer challenged the report. "Even with her
critical perspective, she could not establish that there were inaccuracies in
any of the peer-reviewed articles, or that their authors relinquished control
over their work," the company said.
Use of HRT plummeted in 2002 after the publication
of the Women's Health Initiative study, which found an increased risk of ovarian
cancer, breast cancer, strokes and other health problems from hormone therapy.
Sales of U.S. market leader Wyeth's Prempro have
fallen by about 50% since 2001 to around $1 billion a year.
"Given the growing evidence that ghostwriting has
been used to promote hormone therapy and other highly promoted drugs, the
medical profession must take steps to ensure that prescribers renounce
participation in ghostwriting, and to ensure that unscrupulous relationships
between industry and academia are avoided rather than courted," Dr. Fugh-Berman
wrote.
A 2008 study in the Journal of the American Medical
Association used court papers to suggest Merck had drafted research studies for
its now defunct painkiller Vioxx and then went looking for doctors to add their
names to the studies before they were published.
Dr. Berman's article is available at no charge on
the website of the open-access journal PLoS Medicine (see URL below). The
journal also provides links to all the judicial documents cited in the paper.
PLoS Medicine. Published September 7, 2010.
Abstract
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