The British Medical Journal is on a crusade. Object: Twist Roche's ($RHHBY) arm enough to win full-and-complete access to Tamiflu data. The Swiss drugmaker did promise to hand over all of the data, after questions about safety and efficacy emerged in 2009, but three years later, the books are still closed.
So, BMJ Editor Fiona Godlee has taken the battle to the pages of her journal's current issue. Some 60% of Tamiflu data hasn't been published, Godlee wrote. The two trials that have been were funded by Roche, and written up by Roche employees and external experts paid by the company, she said. So, in an open letter to Roche board member Sir John Bell--who's also an Oxford professor--Godlee asked him to help pry that unpublished data free.
"I am appealing to you as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear," the letter states (as quoted by the Independent). "Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny."
Godlee's letter joins a growing chorus of calls for open access to pharma's trial data. Studies have found that published trial data skews positive, while negative data often doesn't see the light of day. Drugmakers have defended the data secrecy on proprietary-information grounds, but those arguments are less and less persuasive with every drug-safety scandal. And cynicism about pharma-funded studies has grown to the point that recent research showed doctors discount company-sponsored trial data, regardless of the quality of the studies themselves.
GlaxoSmithKline ($GSK) recently went maverick with a promise to open up its data troves, upon request from scientists who need access for their own research, provided they commit to publish their results. In an accompanying BMJ editorial, Godlee commended GSK for its move (with a wait-and-see-how-it-works caveat). She also pointed out the fact that Glaxo's "apparently brave and benevolent action" highlights the "rank absurdity" of current practice. "Why should it be up to the companies to decide?" she asks.
So, BMJ is taking some of that freedom away. The journal won't publish any more clinical trials unless the full data is made available "on reasonable request." The rule takes effect in January.
Meanwhile, the journal has posted correspondence between Roche and the Cochrane Group, which first raised the red flag on withheld Tamiflu data. The email chain dates back to 2009. Roche's most recent response: You have all the data you need, and it's regulators' job to review the detailed info, anyway. How will the company respond to the BMJ now? That's the next question.
- read the BMJ editorial
- see the Independent story
- check out the correspondence
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