Thursday, May 19, 2011

Big Phamra and ghostwriters

Pharmaceutical giant Wyeth hired ghostwriters to counter mounting evidence that its hormone replacement therapy caused breast cancer, according to Congressional investigators in the U.S., who also released documents providing an unprecedented look into how ghostwriting works.

Iowa Republican Senator Charles Grassley has written letters to Wyeth and medical writing company Designwriteasking them to disclose payments made for journal articles and the activities of doctors recruited to put their names on them for publication. The letters are part of a continuing investigation by Grassley into drug industry influence on doctors.

Grassley’s staff on the Senate finance committee also released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

In his nine-page letter to Wyeth chief executive, Bernard J. Poussot, Grassley said the articles were more like advertising than research.

Articles published in medical journals are widely read by practitioners, and relied upon as being unbiased and scientific in nature. Concerns have been raised, however, that some medical literature may be subtle advertisements rather than publications of independent research. The information in these articles can have a significant impact on doctors’ prescribing behavior. ... Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.

One article published as “Editors’ Choice” in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after Wyeth’s Prempro was linked to breast cancer, said there was “no definitive evidence” that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.

The documents released by Grassley show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

Elsevier, the medical publishing house behand The American Journal of Obstetrics, has launched an investigation.

Wyeth maintains that the academic authors were not paid by Wyeth and had “substantive editorial control” of the articles.

The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth’s diet pills, Redux and Pomdimin, withdrawn in 1997 after being linked to heart and lung problems.

The Grassley documents, however, are the first to provide such a detailed look at the practice — from the conception of ideas for journal articles through the distribution of reprints.

Grassley gave Wyeth and Designwrite until Jan. 11 to respond to his letter.


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