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’s 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 “set objectives” and “design the protocol and oversee execution” of the trial (Annals of Internal Medicine, vol 149, p 251).
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“The doctors say the trial was designed to introduce Vioxx to primary-care physicians”
So-called “seeding trials” are considered unethical, partly because patients are exposed to risk without being informed of the trial’s true purpose. Merck even appeared wary of this. One staff member wrote: “It may be a seeding study, but let’s not call it that in our internal documents.”
However, Jonathan Edelman of Merck’s 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.
