Court documents put online last week by PLoS Medicine give the public an unprecedented look into the world of academic publishing and the extent to which big drug companies used ghostwriters to market their products.
The 1,500 documents -- internal memos, meeting agendas and minutes, project tracking report, faxes, cover letters, draft manuscripts and more -- detail the efforts by Wyeth Pharmaceuticals to use top academic journals as marketing tools for its hormone replacement therapy drugs, and to enlist top researchers from around the world to be "authors" of the studies.
The documents were made public last month after PLoS and the New York Times convinced a US court ot unseal documents in a lawsuit to release them to the public. PLoS put them all online last Friday.
Toronto-based senior editor told me yesterday that the public needs access to these document so they can see for themselves what happened.
"The thing that strikes me about the documents is how the campaign is so co-ordinated, so deliberate," Jocalyn Clark says. "Which implies it is a normal course of business."
One document, a May 15, 1997 proposal by DesignWrite to produce ghostwritten articles for Wyeth, bluntly states three main goals for the partnership: boost physician awareness of HRT, “diminish the negative perceptions associated with estrogens and cancer” and lessen the competitive threat of another company’s similar drug.
The proposal, which won DesignWrite a seven-year contract to produce up to 30 articles at up to $25,000 per article, offers Wyeth (referred to as “the client”), full control over the content of the articles.
“After the client has reviewed and released the manuscript for submission, DesignWrite will see it through the necessary production stages – creating camera-ready figures and tables and the text according to journal guidelines and submit the package (manuscript, art cover letter, and any required forms and checklists) to the appropriate journal editor.”
Depositions by several DesignWrite and Wyeth executives are also among the doucments available.
In one such deposition, Karen Mittleman, senior medical writer at DesignWrite, explains the general process for ghostwriting: Wyeth sends data to DesignWrite to be used in a ghostwritten article. An outline is prepared by DesignWrite and sent to Wyeth for review. It then goes back to DesignWrite to prepare a first draft, which takes between four to eight weeks. The draft is sent to Wyeth for review and to a respected researcher in the field, who will also review it and attach his or her name as author.
In many of the documents, a distinction is drawn between “writers,” the anonymous people who pen the articles, and “authors,” the academics who lend their names and reputations to the finished product.
Beyond ghostwriting, the documents indicate, DesignWrite was also hired by Wyeth produced PowerPoint slides to be used by academics when making presentations at industry conferences. Wyeth paid $10,000 for this service.
Trudo Lemmens, a professor of law and medical ethics, has said such help with presentations is often the beginning of the slippery slope drawing academics into a pharmaceutical company’s sphere.
DesignWrite also wrote articles for academic journal supplements at $25,000 apiece, the court documents indicate. Wyeth could then by up multiple copies of the supplements for distribution to doctors’ offices and to give to its sales force to use as evidence of the effectiveness and safety of hormone replacement therapy.
The firm was also instrumental in putting together a patient information handout for doctors to give their patients if they had questions about HRT. The 2001 handout, written by DesignWrite writer Bernadette Janas and sent to Wyeth for approval, reassured women that “HRT does not increase breast cancer risk.”
No mention was made of the role DesgnWrite or Wyeth played in putting the handout together.