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BMJ to only publish trials with open data

Comes as journal pushes Roche for full data on Tamiflu

Roche Tamiflu

The British Medical Journal has said from January 1, 2013, it will only publish clinical trials of drugs for which full data is openly available.

The commitment follows increased efforts from the BMJ to get Roche to publish all available data on its flu drug Tamiflu (oseltamivir), which has drawn concerns about its true efficacy after the US Food and Drug Administration (FDA) concluded that the treatment had not been shown to reduce complications in people with influenza, despite being recommended by other organisations.

The BMJ noted that Roche issued a public promise to release “full study reports” concerning Tamiflu following a request from healthcare review group the Cochrane Collaboration, but has yet to provide access to this data.

“Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided,” said BMJ editor Fiona Godlee, in her editorial announcing the journal's commitment.

Godlee also published an open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member, claiming that evidence for Tamiflu was unreliable as the only two published trials investigating the effectiveness of the vaccine were funded by Roche, and a further eight studies were not accessible.

She said: “Oseltamivir has been a great commercial success for Roche. Billions of pounds of public money have been spent on it, and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny.

“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 on your colleagues on Roche's board.”

Not all pharma companies came under criticism from the BMJ, however, and Godlee praised GlaxoSmithKline's recent decision to allow access to anonymised patient level data from its clinical trial through a panel which will assess requests.

She qualified her statement with some reservations, however: “Whether researchers will find it as easy to get past the panel as [GSK CEO Sir Andrew] Witty suggests we will have to wait and see. It will be particularly important to know how many requests are turned down and for what reasons.”

In return, GSK put its support behind the BMJ's decision to only publish studies where full data was accessible, saying such moves help medical research and improve understanding of medicines.

Patrick Vallance, president of pharmaceuticals R&D at GSK, said: “GSK's ultimate goal is to see a broad system develop where the clinical research community can access data from trials conducted by different organisations. We want to work with others to make this happen.”

The issue of intentionally concealed trial data has received a lot of attention recently due to the publication of Ben Goldacre's book Bad Pharma, which describes several instances where pharma companies have been seen to hide data or use selected information to mislead doctors.

Godlee referenced the book in her editorial, and said its publication influenced the timing of the BMJ's announcement, adding that she hoped that it would capture the wider public's interest.

“The open correspondence on aims to hold specific individuals and organisations to account. Their actions are preventing independent scrutiny of the results of clinical trials and putting patients' lives at risk. We also hope it will contribute to a sea change in the public mood,” she said.

“Goldacre's book presents an opportunity to raise awareness of a scandal too long ignored by those in power. We should seize this moment with both hands.”

1st November 2012

From: Research, Healthcare



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