Servier has committed a serious breach of the Association of the British Pharmaceutical Industry’s Code of Practice by failing to publish clinical trial results on its antidepressant Valdoxan.
The Prescription Medicines Code of Practice Authority says the French drugmaker breached Clause 2, “bringing discredit upon, and reducing confidence in, the pharmaceutical industry” by not releasing data on Valdoxan (agomelatine) “within an internationally agreed timeframe”. Servier was ruled in breach of two other clauses of the 2008 and 2011 Codes: 9.1 – “failing to maintain high standards” and 21.3 – “failing to meet the required timeframe in which to disclose details of clinical trials”.
The PMCPA’s probe was conducted following a complaint by a member of the public, and the panel identified five trials involving patients in the UK between 2008 and 2011 where Servier had not met Code requirements – two of the studies were published a considerable time after completion, while data from three others were still to be disclosed.
Servier, which is not appealing the decision, is the subject of advertisements which appeared over the weekend in the BMJ and The Pharmaceutical Journal. An ad in The Nursing Standard will be published on September 10.
