In a move which appears at odds with a push for transparency within the pharmaceutical industry, AbbVie is suing the European Medicines Agency to prevent it from releasing data related to its blockbuster Humira.
Data transparency is very much in the news but until now the debate has centred around giving access to independent researchers. However, the Financial Times, which has broken the news on the AbbVie suit, notes that it is other drugmakers who have been seeking information.
AbbVie has sought an injunction to block the EMA from granting access detailed data on the effects in individual patients in clinical trials of Humira (adalimumab), the world’s best-selling drug which is approved for a number of indications, notably rheumatoid arthritis. The FT reports that the action, taken in the European Union’s general court, follows two Freedom of Information requests to the EMA this year to release raw data on the drug’s safety and efficacy, one of which was made by UCB.
The newspaper notes that another legal action has been brought against the agency by InterMune, and the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America have lodged supportive pleas.
AbbVie confirmed to the FT that it had filed legal actions to protect the firm’s “confidential and commercially-sensitive information”. The company, created through the split of Abbott Laboratories at the beginning of the year, says it supports “transparency of clinical research and safety information for the benefit of patients and healthcare professionals [but not] the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products”. The FT reports that Belgium’s UCB was one of the drugmakers seeking reports on Humira.
The AllTrials campaign set up by Sense about Science, the British Medical Journal and Bad Pharma author Ben Goldacre, and last month’s PharmaTimes head-to-head debate with Dr Goldacre and Association of the British Pharmaceutical Industry chief executive Stephen Whitehead has put the spotlight on data transparency. However, the EMA has been very firm in its commitment to the proactive publication of data once a drug has completed the marketing authorisation process.
Martin Harvey-Allchurch, head of communications at the EMA, confirmed to PharmaTimes World News that three cases have been brought (two by AbbVie and one by Intermune), after the agency had informed the companies involved that requests had been made and they are pending. He noted that “we will continue to respond and process all requests” for data information unless informed otherwise by the European courts.
