AbbVie seeks injunction to protect trial data secrecy

Three_wise_monkeys_figure AbbVie is seeking a legal injunction to block the European Medicines Agency (EMA) from publishing clinical trial data relating to its rheumatoid arthritis drug Humira.

The biopharmaceutical company claims that publishing the trial data would violate both commercial confidentiality and patient confidentiality.

AbbVie’s position contrasts with that of GSK, which has committed to publishing all its future and past clinical trial data, and shows that the pharma industry is becoming polarised on this issue.

The EMA has committed to publish all clinical trial data once a drug has completed marketing authorisation from the start of 2014.

The AllTrials ‘open data’ movement, which GSK now supports, has been driven by medical authorities including the Cochrane Collaboration and the BMA.

The AllTrials position is that secrecy around clinical trial data rewards dishonesty in the planning and reporting of trials, and that transparency is in the interests of all patients and all honest pharma companies.

AbbVie, which recently split off from Abbott, has the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in seeking to protect clinical trial data as ‘confidential’.

By preventing the EMA from publishing the clinical trial data relating to Humira (adalimumab), AbbVie seeks to ensure its own right to select which data are available to prescribers and patients.