Clinical trial data for all drugs in current use must be made available for independent scrutiny
by Fiona Godlee editor in chief
British Medical Journal, London WC1H 9JR, UK
October 29, 2012
… Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? Why should it take 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?
In ancient times, the drug companies were always around. Detail men with plastic brains and free pens. Throw-away journals with drug company articles filled our boxes. Medical journals had glossy pages of ads with snappy art work. I never saw that as a problem. It was no different than commercials on television. Sometimes something caught your eye, but mostly it was just part of the background noise of life. But then things changed, at least in psychiatry. The peer reviewed journals got thicker and were filled with clinical trial papers. The articles about the phenomenology of mental illness were replaced with reviews of medications and endless clinical trials. At first we didn’t notice they were industry financed. Then we didn’t notice the conflict of interest statements. Then we found out the authors didn’t write them. And before long, our scientific journals filled up with articles that looked like the scientific articles of yore, but read like the stuff formerly in the throw aways. Harvard, Brown, Stanford, Emory, etc. stopped meaning what it used to mean. Even editorials became suspect. For that matter, so did textbooks. In psychiatry, famous doctors became drug reps with CVs that weren’t even possible – like hundreds and hundreds of articles. The author by-line was more like celebrity endorsements than authorship.
So the reason Fiona Godlee’s BMJ announcement is so perfect is that she’s skipping all the pieces in-between and getting to the heart of the matter. If you won’t let us see your patient-level raw data to allow our peer reviewers to genuinely vet your science, we won’t consider your article. Peer reviewers have been at the same disadvantage as readers – unable to tell whether the story as presented is accurate or skillfully dolled up. With her solution in place, their work is cut out for them, but their power to adequately evaluate a study is magnified geometrically. They can look at the raw plots freed from the layers of statistics and presentation tricks that haunt the modern literature. But the greatest boon is to the reader who can pick up her journal and know that it has been checked at the most basic level by an independent expert who is not on the company payroll. Perfect.