IT LOOKS like a regular clinical trial, but a group of doctors is alleging that the design of a study involving controversial painkiller Vioxx was heavily influenced by the maker鈥檚 marketing staff.
The study, which was published in the Annals of Internal Medicine in 2003, found that Vioxx, made by Merck, caused fewer side effects than another painkiller. Merck subsequently withdrew Vioxx because of safety concerns. In the court cases that followed, the firm released its internal memos.
After analysing the memos, doctors led by Kevin Hill of McLean Hospital in Belmont, Massachusetts, say that Merck staff described the trial as being designed to introduce Vioxx to primary-care physicians, who issue most prescriptions for painkillers to treat arthritis, and that the marketing department, not scientists, had responsibilities to 鈥渟et objectives鈥� and 鈥渄esign the protocol and oversee execution鈥� of the trial (Annals of Internal Medicine, vol 149, p 251).
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鈥淭he doctors say the trial was designed to introduce Vioxx to primary-care physicians鈥�
So-called 鈥渟eeding trials鈥� are considered unethical, partly because patients are exposed to risk without being informed of the trial鈥檚 true purpose. Merck even appeared wary of this. One staff member wrote: 鈥淚t may be a seeding study, but let鈥檚 not call it that in our internal documents.鈥�
However, Jonathan Edelman of Merck鈥檚 Global Center for Scientific Affairs says that the trial was run by researchers, not marketing officials, and that the staff who called it a seeding trial were misinformed.
