Sunday, July 09, 2006

"Can We Tame the Monster?"

Provoked by Dr David Healy's revelations about how drug companies manipulated the clinical research literature about selective serotonin reuptake inhibitors (SSRIs) (see post here), and the continuing Vioxx scandal, British Medical Journal Editor Fiona Godlee has taken on the pharmaceutical industry with a radical proposal. (See her editorial: Godlee F. Can we tame the monster? Brit Med J 2006; 333: )

She wrote that the SSRI and Vioxx cases are just symptoms of "a wider disease: an overpowerful, under-regulated drug industry and a research establishment and publishing industry in its thrall." Although, "between the interests of the public and the commercial interests of drug companies stand two potential safeguards—journal peer review and drug regulation," both these safeguards are stressed. "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." Meanwhile, "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."

Dr Godlee's solution is radical: "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."

This is certainly bolder than the cautious proposals I put forth in response to Dr Healy's latest article. Therefore, Dr Godlee's approach may be more effective.

My major worry is how difficult it will be to make clinical trials truly independent. In the US, the natural approach would be to have the federal government fund and supervise the trials, to be done by medical schools and academic medical centers.

However, we have shown repeatedly how pervasive conflicts of interest are in these institutions (see recent post here). Would the most conflicted academic medical leaders really allow research to be independent? Would faculty members with all sorts of financial ties to the makers of drugs and devices really conduct independent evaluations of them?

In my humble opinion, to re-establish clinical research that is independent of vested interests, we will have to tear about the web of conflicts of interest that pervades global health care.

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