Merck catches more flak over dangerous drug

By Jim Giles It looks like a regular report of a clinical trial – it contains the usual mix of data, statistics and analysis. But a group of doctors is alleging that a paper 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 Vioxx, a painkiller that was manufactured by Merck. In patients with osteoarthritis, said the paper’s 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. 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’s marketing department had responsibilities to “set objectives” and “design the protocol and oversee execution” 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 “seeding studies” 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, “It may be a seeding study, but let’s not call it that in our internal documents”. 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. “Up until now there had only been circumstantial evidence,” says Lexchin. “This is the one that says ‘gotcha’.” Jonathan Edelman, of Merck’s 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,
  • 首页
  • 游艇租赁
  • 电话
  • 关于我们