Press release from PLoS Medicine
Today, PLoS Medicine places in the public domain all documents - around 1500 - released after the journal and The New York Times intervention in the Prempro case. The documents, are available on the PLoS Medicine website, and are uploaded in the form that PLoS received them from the court.
The documents include internal correspondence, reports, and tracking documents relating to interactions between the pharmaceutical company Wyeth and a medical communications firm, to promote Wyeth's hormone drugs. These documents show in considerable detail a coordinated and carefully monitored campaign of "ghostwriting" by Wyeth and medical writing companies for a number of products marketed by the company.
Ghostwriting, which involves using medical writers to produce articles that are then nominally authored by an academic not substantially involved in the writing process, has been condemned as an unacceptable practice by medical journals and editors. Nonetheless, the practice appears to persist and by placing all the documents for scrutiny in the public domain, the editors of PLoS Medicine hope that they will help guide the way to identifying reforms that will eventually stamp ghostwriting out.
In order to make these documents available, PLoS Medicine, represented by public interest law firm, Public Justice, and The New York Times intervened in an ongoing court case in which women were suing Wyeth, the manufacturers of Prempro, a hormone replacement therapy. During the discovery process for this case, one of the lawyers representing injured women in the litigation, Jim Szaller of Cleveland, Ohio, had become aware of many documents that laid out in detail the company's (mostly successful) attempts to publish papers written by unacknowledged professional medical writers in which the message, tone, and content had been determined by the company but the paper was subsequently nominally "authored" by respected academics.
In an editorial that has been posted on the PLoS Medicine blog, Speaking of Medicine, the PLoS Medicine editors declare that this is "one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public." The editors go on to call for action to eradicate ghost-writing, including retraction of papers where ghostwriting or inappropriate involvement of medical writers is found, banning of authors found to have put their names to such papers from any subsequent publication in the journal, and rigorous investigation of such misconduct by the researchers' academic institutions.
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