BMJ open data campaign:
I’m not sure that long link will come out here, but I’ll give it a try. The timeline is an interactive created to support the British Medical Journal (BMJ) in their continued request for the open clinical trial data earlier promised by Hoffmann-La Roche Ltd, the drug company who make the flu treatment and preventitive, Tamiflu, also known as Oseltamivir. I know, that was quite a mouthful. The gist of it is this.
BMJ questions whether Tamiflu really works. Roche promised the data, but never delivered. They keep being asked, and it gets less and less convincing as time goes on.
There is also quite an extensive discussion of this in Wikipedia.
There is also a fascinating editorial from BMJ editor in chief, Fiona Godlee.
In that she says:
“Despite a public promise to release “full study reports” (internal company reports) for each trial, each of which can run to thousands of pages, Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.”
The more important plea is for opening clinical trial data for ALL studies.
“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),5 6 strong arm tactics by national licensing bodies (Pfizer’s reboxetine),7 and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir)8 to try to piece together the evidence on individual drugs?”