July 7

Can We Tame the Monster?

BMJ editor, Dr. Fiona Godlee, commenting on the drug industry’s stranglehold on the scientific medical literature–which has in large part been tainted under industry’s influence–she acknowledges the dismal failure of journal peer review and drug regjulators’ reviewing process to curtail industry’s
influence and to ensure that clinical trial findings are truthfully reported.  She rejects some of the half-measures proposed by others and throws her towel with Dr. Marcia Angell by calling for a complete separation (a fire wall) between drug manufacturers and the scientific evaluation process.

"To get their products licensed they would contribute to a central pot for
independent, publicly funded clinical trials."

My own response to her question, "Is it feasible?"
Achieving acceptable drug safety evaluation standards is perfectly feasible, it’s a matter of political will to put the public health first, commercial considerations second.

Contact: Vera Hassner Sharav

BMJ  2006;333 (8 July), doi:10.1136/bmj.333.7558.0-f
Editor’s choice
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]
33/7557/12> )? 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 But rofecoxib was withdrawn two years ago, so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:

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
<http://bmj.bmjjournals.com/cgi/content/full/bmj;333/7558/92 > ).

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]
354/2/194> . 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

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