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Roche promises greater access to clinical trial data

Company critics say measures do not go far enough

Roche Basel Switzerland

Roche has said it will allow access to clinical trial results for all of its licensed medicines, and to other drugs on request, in a bid to defuse criticism for withholding data.

The announcement failed to win over critics of the company, which has been criticised for withholding data on the effectiveness of flu drug Tamiflu (oseltamivir) in a series of letters published in the British Medical Journal.

Roche sold enormous quantities of Tamiflu to national governments during the swine flu epidemic, and there have been concerns that this could have been a waste of money if the drug's effectiveness has been overstated.

Roche Tamiflu

(Image: Roche Tamiflu) 

In response to the criticism Roche has proposed to allow access to anonymised patient-level data, which have been submitted alongside a marketing application for medicines, but on a case-by-case basis with requests evaluated by the company and an independent body, and only after the completion of regulatory reviews in the US and EU.

The company also said it was discussing whether this approach might become an industry-wide initiative with other pharma companies, and was making arrangements to bring its entire Tamiflu dataset into the public domain for review by an independent panel.

The proposed measures do not go nearly far enough, according to advocates of clinical trial transparency.

Peter Gøtzsche of the Nordic Cochrane Centre - who has called in the past for European governments to sue Roche for withholding data - criticised the company for attaching conditions to data access.

"This is the view of the European Commission … and the view of the EMA," he told PMLive. "Roche wants to stay in control. This is unacceptable and not what we understand by independent research."

Questions have also been raised about the candidates included in Roche's proposed Tamiflu panel, with one observer suggesting it was weighted in favour of Roche and pharma key opinion leaders (KOLs).

"It is bizarre to see that Roche expects to be praised today for continuing to withhold data," commented Dr Ben Goldacre, who has tackled the issue of data transparency in his book Bad Pharma. "Future generations will look back in amazement that we ever tolerated this situation."

Goldacre praised GlaxoSmithKline for its recent decision to sign up to AllTrials.net, a campaign to see all clinical trials registered and all their results reported, with full clinical study reports to be made publicly available. AllTrials.net has the support of the Medical Research Council, the Wellcome Trust, the National Rheumatoid Arthritis Society and the National Physicians Alliance from the US, amongst others.

"We imagine that we are practicing evidence based medicine, we spend tens of millions of dollars on each individual trial, we obsess over ensuring it is free from bias, and then at the final furlong we allow results and other information to be withheld," he added.

"To me, this seems as absurd as mediaeval doctors' bloodletting."

27th February 2013

From: Research, Regulatory

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