Hormone replacement therapy drugs such as Premarin and Prempro were widely popular in the 1990s among women seeking to avoid the symptoms of menopause. The drugs became some of Wyeth's best sellers, raking in more than $2 billion for the company until a 2002 study showed that they significantly increased women's risk of invasive breast cancer, heart disease and stroke. Later research also implicated the drugs in an increase dementia risk among the elderly.
Use of hormone replacement therapy plummeted, with a corresponding drop in breast cancer rates. Since then, approximately 8,400 lawsuits have been filed against drugmakers Wyeth and Pfizer by more than 10,000 women affected by side effects. More than 8,000 of these lawsuits have been consolidated into a single case, before U.S. District Judge William Wilson in Arkansas.
Wilson ordered Wyeth's ghostwriting documents unsealed in response to a request by the defendants, the journal PLoS Medicine and the New York Times. The documents reveal that between 1997 and 2005, Wyeth paid medical communications firms to ghostwrite at least 40 articles that promoted hormone replacement for treatment of not just menopause symptoms, but also other conditions such as Parkinson's disease. These articles, many of them reviews of prior studies, played up the benefits of the hormone drugs while downplaying their risks. The communications firms also secured doctors to put their names on the studies as authors.
The articles were published in 18 different medical journals. Neither Wyeth nor the studies' purported authors informed the journals that the company had funded the studies and employed their writers.
The case of DesignWrite Inc. is indicative of Wyeth's larger ghostwriting practices. Wyeth hired the firm in 1997, at which time DesignWrite proposed a two-year plan to promote the company's hormone drugs by securing the publication of 30 different articles.
In 2003, the company drafted a 14-page outline of one article, with the author listed as "to be determined." This outline was sent to Dr. Gloria Bachman of the Robert Wood Johnson Medical School in July, and she agreed to put her name on the study. She was sent a draft of the completed article in September and replied, "I had only one correction which I highlighted in red."
The article, which was published in The Journal of Reproductive Medicine in 2005, disparaged non-hormonal treatment for hot flashes, referring to hormone replacement therapy as the "gold standard."
Wyeth paid DesignWrite $25,000 for the production of the article.
The Prempro case is not Wyeth's first ghostwriting scandal; the company was previously forced to pay $21 billion in lawsuits over the diet drug fen-phen, which was also marketed using ghostwriters. Indeed, the new documents suggest that ghostwriting journal articles is a standard practice for many pharmaceutical companies, raising concerns that doctors might have their prescribing habits influenced by articles that were actually produced as part of corporate marketing campaigns.
"The filter is missing when the reader does not know that the germ of an article came from the manufacturer," said attorney James Szaller, representing many of the plaintiffs.
Medical journal publisher Elsevier has announced an investigation into ghostwriting practices, and some journals have started requiring full disclosure of each author's role in producing a paper, as well as any conflicts of interest. Many journals, however, do not require this disclosure, and the extent of ghostwriting practices remains unknown.
"It's almost like steroids and baseball," said Joseph S. Ross, of Mount Sinai School of Medicine. "You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't."