From the BMJ - Here be monsters!

Can we tame the monster?

What can we learn from the New England Journal of Medicine's correction last week of its study on rofecoxib (BMJ 2006;333: 12, 1 Jul[Free Full Text])? 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 But rofecoxib was withdrawn two years ago, so why all the fuss?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. But the stand-off between journal and drug company is just one symptom of a wider disease: an overpowerful, under-regulated drug industry and a research establishment and publishing industry in its thrall.

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.

Writing in PLoS Clinical Trials (2006;1: e6)[CrossRef] in May, Richard Smith and Ian Roberts proposed a different model for disseminating the results of clinical trials. Protocols and analyses would be prespecified and posted for discussion, and full datasets would be uploaded on completion of the trial. The role of journals would be limited to providing commentaries.

Is this feasible? Is it the answer?

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. In this week's BMJ, David Healy examines how the regulators failed to highlight the risks of selective serotonin reuptake inhibitors in depression (p 92).

The US Food and Drug Administration has taken steps to reform, but critics want more. Writing in the New England Journal of Medicine, Wayne Ray and colleagues call for the establishment of three independent centres in charge of drug approval, postmarketing studies, and drug information (2006;354: 194-5)[Free Full Text].

As for the UK Medicines and Healthcare Products Regulatory Agency, it is seen by many as unaccountable, slow, and lacking the necessary expertise. It too needs urgent review and reform.

I suggest a more radical solution. As with most good ideas, it is not mine alone. Marcia Angell (personal communication) and Des Spence (BMJ 2006;332: 1155-6, 13 May[Free Full Text]) have also had it, but here is my version. 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?

Fiona Godlee, editor, BMJ

fgodlee@bmj.com