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Roche offers compromise in Tamiflu data debate

Comes as EMA holds workshop on clinical trial data and transparency

Roche

Roche has said it intends to hold talks with its critics about the possibility of releasing more data about its influenza drug Tamiflu.

The company has been under fire in recent weeks for its lack of transparency regarding the drug's efficacy and safety, with the British Medical Journal leading a campaign for the release of full study reports, while a researcher from health research body the Cochrane Collaboration has called for a boycott of Roche's products until it does so.

Now Roche has written to the head of the Cochrane Collaboration about setting up a multi-party advisory board, including experts from academia and industry, to review all the data behind Tamiflu, which made Roche almost $3bn during its peak year of 2009 when fears about the swine flu pandemic were at their height.

Roche's decision last week came on the same day that the European Medicines Agency (EMA) held a workshop to discuss access to clinical trial data and transparency.

Speakers at the workshop included Ben Goldacre, whose book Bad Pharma, which has a chapter dedicated to the Tamiflu controversy, has helped drive the transparency debate.

The EMA, which has previously extolled the benefits of open access in a article for the journal PLoS Medicine, said the workshop marked the “first step in the process to proactive publication of clinical-trial data”.

This statement of intent was backed by the Agency's executive director Guido Rasi in his opening remarks.

He said: “The European Medicines Agency is committed to proactive publication of clinical-trial data, once the marketing-authorisation process has ended. We are not here to decide if we publish clinical-trial data, but how.”

Following the workshops, several advisory groups comprising stakeholders from all involved partiers will be formed to work on five priority areas of policy for any changes to transparency legislation.

These areas are protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and the legal aspects of open access.

Final advice from each advisory group is expected by the end of April 2013, while the proactive publication of clinical-trial data is expected to come into force on January 1, 2014.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which has previously voiced concerns over “indiscriminate” data transparency, said the workshop gave a “constructive insight” into the access debate, but all parties needed to take several issues into consideration.

These included the need to protect commercially confidential information and protected personal data, as well the opportunity for companies to seek appropriate redactions prior to any disclosure.

Whether the intended recipient of a data request is an independent researcher or a rival company should also be taken into consideration regarding any data request, with the latter posing a risk of “innovation and know-how being unfairly and unreasonably used by a competitor”.

26th November 2012

From: Research, Regulatory

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