Servier slammed over UK trial transparency failure
Servier has been found guilty of the most serious breach of the UK’s pharma code of conduct after failing to publish full details of several trials for its depression drug Valdoxan.
An anonymous complainant used the ABPI’s recent study on trial data disclosure called ‘Current Medical Research & Opinion’, which was published late last year, to bring Servier to account.
This study inadvertently detailed a number of companies which had not disclosed their clinical trial results in line with the ABPI for licensed products, with Servier’s Valdoxan (agomelatine) being one among many that was brought by the complainant to the PMCPA, which polices the ABPI’s Code on pharma’s conduct.
The same complainant has also made similar grievances using the ABPI’s study for Bristol-Myers Squibb; Takeda; Ferring; and Novartis, among a host of other firms. So far, only Servier has fallen foul of the Code’s rules.
The PMCPA looked at the studies undertaken in the UK during 2009 and 2010, and had to refer to older versions of the Code, namely in the years that these trials were being undertaken.
In its official ruling, the PMCPA’s panel says that Servier should have disclosed the results for one study (known as Study 25) by March 2010, and the other study (Study 26) by April 2010.
But the panel found that the results “were not disclosed within this timeframe Servier had not met the requirements of the Code”.
The Panel has therefore ruled a breach of the 2008 Code, adding that the delay in disclosure meant that “high standards had not been maintained and a breach was ruled”.
It adds that Servier knew from the ABPI’s publication that some of its trial data results had not been disclosed, meaning it had the time to do something about the publication.
The study was conducted between December 2012 and January 2013, but in the nearly ten months that had elapsed between the end of the study and the receipt of this complaint, the company had not subsequently disclosed the missing data (Studies 30 and 31).
The Panel considered that was also a ‘failure to disclose the data’, and meant that high standards had not been maintained, and ruled another breach.
The PMCPA overall ruled that the failure to disclose these data meant that Servier has “brought discredit upon, and reduced confidence in, the pharmaceutical industry”, making it guilty of breaching Clause 2, the most serious breach a pharma company can make.
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