It looks like a regular report of a clinical trial 鈥� it contains the usual mix of data, statistics and analysis. But a group of doctors is alleging that a published in Annals of Internal Medicine in 2003 has been heavily influenced by the marketing division of the pharmaceutical giant, Merck.
The Annals study reported positive results for , a painkiller that was manufactured by Merck. In patients with osteoarthritis, said the paper鈥檚 authors, the drug caused fewer side effects than naproxen, another commonly prescribed painkiller
But a year after the trial was published, Merck withdrew Vioxx owing to safety concerns. In the court cases that followed, where Merck eventually agreed to pay out $4.85 billion in settlements, internal company documents were released. These reveal the true nature of the study, say Kevin Hill of McLean Hospital in Belmont, Massachusetts, and colleagues.
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The documents include memos in which Merck staff describe the trial as being designed to introduce Vioxx to primary-care physicians, who the company knew issued most painkiller prescriptions for arthritis patients.
The papers quotes a memo saying that Merck鈥檚 marketing department had responsibilities to 鈥渟et objectives鈥� and 鈥渄esign the protocol and oversee execution鈥� of the trial.The company collected data on the prescription habits of the doctors involved and noted that more were prescribing Vioxx by the end of the trial.
The use of such 鈥渟eeding studies鈥� is considered unethical, in part because patients are exposed to risk without being properly informed of the purpose of the trial. Merck staff appeared wary of this being revealed. In an internal email, a marketing division staff member says, 鈥淚t may be a seeding study, but let鈥檚 not call it that in our internal documents鈥�.
Physicians were aware that such studies existed, but this is the first time that an individual trial has been definitively identified as such, notes Joel Lexchin, a public health expert at the University of Toronto. 鈥淯p until now there had only been circumstantial evidence,鈥� says Lexchin. 鈥淭his is the one that says 鈥榞otcha鈥�.鈥�
Jonathan Edelman, of Merck鈥檚 Global Center for Scientific Affairs, says that the trial was run by researchers, not marketing officials. He says that the two groups work within the same division but are independent of each other, and adds that colleagues who referred to it as a seeding trial were misinformed.
Journal reference:Annals of Internal Medicine (vol 149, p251)
