Archive for October 11th, 2010

Another Medical Ghostwriting Escapade

October 11th, 2010 | No Comments | Source: BurrillReport

Unsealed documents from a dispute involving Wyeth Pharmaceuticals show the drug company paid ghostwriters to prepare articles that emphasized positive findings about post-menopausal hormone replacement therapy as part of a strategy to stem growing public concern about the treatment.

The articles include several dozen clinical trial reports and literature reviews. They were reviewed by Adriane Fugh-Berman, an associate professor in the Physiology Department at Georgetown.

Fugh-Berman published her review in PLoS Medicine. She presented her findings while serving as a paid expert witness in a court case brought by 14,000 plaintiffs. These people allege that their breast cancer might have been caused by a Wyeth-made hormone replacement drug known as Prempro.

In her testimony, Fugh-Berman said the ghostwriting strategy included promoting off-label, unproven uses of Prempro such as the prevention of dementia, vision problems, wrinkles and Parkinson’s disease. The strategy also featured a hearty defense of supposed cardiovascular “benefits” of hormone replacement therapy and an attempt to cast doubt about several competing therapies.

The ghostwritten articles were circulated to drug representatives and eventually to physicians.

The ghostwriting outfit at the center of the matter is DesignWrite, medical education and communication company. Wyeth or its representatives apparently paid DesignWrite $25,000 per ghostwritten report of a clinical trial. DesignWrite also wrote 20 review articles, receiving $20,000 a pop.

“The medical profession must ensure that prescribers renounce participation in ghostwriting, and ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” the PLoS study says.

In a statement to Reuters, Pfizer (which now owns Wyeth) tried to dismiss the report. “Even with her critical perspective, (Fugh-Berman) could not establish that there were inaccuracies in any of the peer-reviewed articles, or that their authors relinquished control over their work,” the statement said.


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