BMJ Editorial: Clinical trial data for all drugs in current use must be made available for independent scrutiny

BMJ Editorial: Clinical trial data for all drugs in current use must be made available for independent scrutiny

A hard-hitting editorial published in today’s BMJ by Fiona Godlee, BMJ Editor in chief, raises the call for clinical trial data for all drugs in current use to be made available for independent scrutiny.

The article begins with a quote from Ben Goldacre’s introduction to his new book Bad Pharma, “Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.” It goes on to highlight the absurdity of the current situation in which all clinical trial data is NOT routinely available for independent scrutiny once a regulatory decision has been made, in which commercial companies are allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators, in which it is up to the companies to decide who looks at the data and for what purpose, and in which it takes legal action (as in the case of GlaxoSmithKline’s paroxetine and rosiglitazone), strong arm tactics by national licensing bodies (Pfizer’s reboxetine), and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir) to try to piece together the evidence on individual drugs.

The article also highlights the three year battle the BMJ has been engaged in to gain access to the full data on oseltamivir (Tamiflu), so far still without success, and the steps the BMJ will take to intensify its efforts in this ongoing battle.

Finally, the editorial announces that from January 2013 the BMJ will no longer publish clinical trials of drugs and devices—whether industry funded or not—unless there is a commitment to make the relevant anonymised patient level data available on reasonable request. The International Committee of Medical Journal Editors has so far declined to take such a step.

Read more: http://www.bmj.com/content/345/bmj.e7304

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7304 (Published 29 October 2012)

No Comments

Post A Comment