Journal editor asks: Can we tame the monster?

And the monster is "an overpowerful, under-regulated drug industry and a research establishment and publishing industry in its thrall," according to BMJ editor Fiona Godlee. She reflects this week on last week's correction by the New England Journal of Medicine of a study it published on rofecoxib (Vioxx).

Excerpts of her editor's note: "The simple message is that increased cardiovascular risks were visible as early as four months into treatment, rather than the 18 months that Merck had claimed. But rofecoxib was withdrawn two years ago, so why all the fuss?

Well, reputations are at stake. The journal wants to show that it had made no mistakes in peer reviewing the study. And Merck, having already incurred financial loss, needs to protect its share price. ...

Between the interests of the public and the commercial interests of drug companies stand two potential safeguards—journal peer review and drug regulation. The pressures on journals to publish drug industry trials include the need for newsworthy content and revenues from reprint sales. These pressures are intensifying, and recent examples of selective reporting and data manipulation have made clear that peer review in its current form is unequal to the task. ...

Drug regulators too seem unequal to their task. Critics focus on their close relationship with industry; their lack of transparency; their lack of systematic post marketing surveillance; and an emphasis on efficacy over patient safety, which favours industry. ...

I suggest a more radical solution. ...Drug companies should not be allowed to evaluate their own products. To get their products licensed they would contribute to a central pot for independent, publicly funded clinical trials. Is this feasible? Is it the answer?"

About this Entry

This page contains a single entry by Gary Schwitzer published on July 7, 2006 8:01 AM.

How drug companies squelch negative findings was the previous entry in this blog.

Big provider pays big bucks for unnecessary surgery is the next entry in this blog.

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