Shire has once again fallen foul of the ABPI Code of Conduct after using a press release for its Gaucher’s disease drug Vpriv to knock a rival product.
The complaint was brought by Sanofi’s subsidy Genzyme, which makes a rival Gaucher’s disease drug Cerezyme (imiglucerase).
Genzyme contends that a press release from Shire, sent out last year in the UK, was “not accurate, balanced, fair or based on up-to-date information”.
The PMCPA – which polices the Code – agreed, saying many of the trial data used to compare Vpriv to Cerezyme were “misleading” and based on limited exploratory data.
This comes almost one year after Shire was found guilty by the PMCPA of breaching clause 7.2 of the ABPI Code after it incorrectly compared the efficacy of Cerezyme to Vpriv, saying on its website that it was “at least as effective as” Cerezyme.
But Genzyme said that ‘at least as effective as’ did not properly describe the results of a non-inferiority study, and alleged that the claim was “unbalanced, misleading and exaggerated” – the PMCPA agreed and a breach was ruled.
But this does not seem to have stopped Shire’s behaviour, as it has now been found guilty of no less than 10 breaches of the Code, all relating to how the rare disease specialist has used clinical trial data in a press release when comparing its drug to Cerezyme.
The PMCPA said that the data were “insufficient” to make a comparison against Cerezyme, and the press release “was misleading” in this regard, especially as it had been aimed at a patient organisation.
It also found – on appeal – that the press release was promotional given its use of comparisons, and also ruled the firm in breach in this regard, as promotional releases are strictly banned in the UK and Europe.
In all, the firm was found guilty of 10 breaches: specifically clauses 1.8, 2, 4.1, 7.2, 7.3, 8.1, 14.1, 14.5, 22.1 and 22.2.
Because of the extent of breaches and seriousness of its on-going behaviour, Shire was found guilty of the most serious breach: clause 2 of the Code - bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
The PMCPA said it had concerns about the content of the press release and said was “not a fair reflection of the study” and sending this type of promotion press release with flawed data for public consumption – and especially to patient organisations - was “wholly unacceptable”. Shire appealed against this ruling, but was knocked down and found guilty of clause 2.
The firm will now be publicly reprimanded in a number of medical journals.