Ghostwriting, defined as the practice of using a professional writing company to draft a manuscript, entered the American lexicon when the Wall Street Journal and the New York Times reported on the actions of Sen. Charles Grassley to conduct a congressional investigation into drug companies’ influence on doctors.
Plaintiffs in 8,000 lawsuits involving the use of Prempro (the combination of Premarin and Progestin, which are synthetic hormones for hormone replacement therapy) sought to establish the link between the drug and breast cancer. As a result, Wyeth was forced to turn over about 40 articles in medical journals and other publications alleged to have been ghostwritten. The articles had been designated confidential before the series of trials relating to Prempro began in 2006.
In these trials, the plaintiffs alleged that Wyeth, which conjured up the concept for the articles to counteract criticism of Prempro as well as to embellish its benefits, hired a professional writing company to draft the articles to convey Wyeth’s message about the drug. But Wyeth retained a doctor to sign off as the study’s author. The company then found publishers to print the articles (in some instances unwittingly). Wyeth sales representatives were given the articles to present to practicing physicians as independent proof that Prempro was safe and effective. Sen. Grassley targeted Wyeth’s actions in the investigation.
The New York Times and PLoS (a biomedical journal published by the Public Library of Science in Great Britain without ads from drug companies) filed a motion asking the judge in the Prempro lawsuits to set aside the confidential designation enjoyed by Wyeth on these documents. On Friday, July 24, 2009, U.S. District Judge Bill Wilson ordered Wyeth’s papers unsealed. While Wyeth attorney Stephen Urbanczyk acknowledged the articles are part of a marketing effort, he claimed them to be fair, balanced and scientific. The plaintiffs’ attorney, Eric Walker, retorted with a question: “Why don’t they want to turn loose of them? Because it makes them look bad.”
There has been an ongoing effort to force drug companies to provide physicians and consumers all the data involving drugs in order that decisions can be made objectively about the use of certain pharmaceuticals. Until now, prescribing decisions have been made solely on the basis of marketing information that was bought and paid for by the pharmaceutical firm seeking to sell more of its medications. AAHF has closely followed the issue, writing about the FDA‘s seeming to do the bidding of Wyeth in its effort to prevent bio-identical hormones, produced by a competitor of Wyeth’s, from ever hitting the market.