A study of documents unsealed in litigation against the pharmaceutical company Wyeth (WYE) show the drug giant paid ghostwriters to insert marketing messages into articles in medical journals, according to researchers at Georgetown University Medical Center in a study published in PLoS Medicine.
In July 2009, PLoS Medicine, represented by the public interest law firm Public Justice, and The New York Times, acted as interveners in litigation against menopausal hormone manufacturers by 14,000 plaintiffs whose claims related to the development of breast cancer while taking the hormone therapy Prempro. This resulted in a U.S. federal court decision to release approximately 1,500 documents to the public.
The study author Adriane Fugh-Berman, who was a paid expert witness on behalf of plaintiffs in the litigation, says that Wyeth paid the medical education and communication firm DesignWrite to ghostwrite articles to counter concerns about the risks of breast cancer associated with hormone therapy, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles.
Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that she says were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy—and to cast competing therapies in a negative light. The articles were widely circulated to drug reps and doctors to disseminate the company's marketing messages.
The study found that DesignWrite was paid $25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid $20,000 each.
“Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” the study says.
Pfizer (PFE), which acquired Wyeth in 2009, sought to dismiss the report in a statement provided to Reuters. The drugmaker noted that Fugh-Berman was a paid expert witness for the plaintiffs in the hormone therapy litigation. “Even with her critical perspective, she could not establish that there were inaccuracies in any of the peer-reviewed articles, or that their authors relinquished control over their work,” Pfizer said.