2013, BMJ will publish articles on
drugs and devices only if the clinical trial data is made available for
independent scrutiny—whether industry funded or not.
In an editorial published October 29, BMJ Editor in Chief Fiona Godlee says
the recent "brave and benevolent" decision by GlaxoSmithKline (GSK) to allow access to
anonymous patient level data from its clinical trials "really serves to
highlight the rank absurdity of the current situation. Why aren't all clinical
trial data routinely available for independent scrutiny once a regulatory
decision has been made?"
GSK's new policy, an independent panel will assess all requests and access will
be granted on the basis of a reasonable scientific question, a protocol, and a
commitment from the researchers to publish their results. Godlee says it will
be "particularly important to know how many requests are turned down and
for what reasons."
also writes that BMJ has intensified
its efforts to help resolve a 3-year battle to gain access to full data on
oseltamivir (Tamiflu). Taxpayers in the United Kingdom and around the world "have
spent billions of dollars stockpiling a drug for which no one except the
manufacturer has seen the complete evidence base," she says.
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