Shire’s Vpriv website in breach of ABPI Code
Shire’s website for its Gaucher’s disease drug Vpriv has fallen foul of the ABPI’s Code of Conduct.
The complaint was brought by Sanofi’s subsidy Genzyme, which makes a rival Gaucher’s disease drug Cerezyme (Imiglucerase), also an enzyme replacement therapy.
Shire’s site compared the efficacy of Cerezyme and Vpriv, and said that its drug was ‘at least as effective as’ Cerezyme
But Genzyme said that ‘at least as effective as’ did not properly describe the results of a noninferiority study, and alleged that the claim was ‘unbalanced, misleading and exaggerated’.
The PMCPA, which polices the Code, agreed with Genzyme, and ruled a breach of clause 7.2 of the Code. It said that non-inferiority studies showed that even if one product was worse than the other, it was only worse within clinically unimportant limits.
The phrase ‘at least as effective as’ not only implied equivalence but also possible superiority, which was misleading and did not reflect the available evidence.
Genzyme also said that the health professionals’ part of the website was easily accessible, allowing the public to read promotional claims – something restricted under the Code.
But the PMCPA did not agree with Genzyme on this issue. The welcome page of the Vpriv website asked the reader to enter the section of the site that was most relevant to them, by clicking on either ‘I am a patient, carer or family member’ or ‘I am a healthcare professional’.
If the reader clicked on the latter, they were asked to reconfirm that they were a health professional – only by reconfirming their professional status could they access promotional material for the drug.
The Panel considered that the section providing promotional information to health professionals was clearly separated from the section containing information for the public, patient, carer or family member, and the intended audience for each section was clear.
The PMCPA concluded that the site did not encourage a member of the public to ask their health professional to prescribe a prescription only medicine, and no breach was ruled.
Claims over manufacturing
The PMCPA also said that Shire was in breach over its claims about how Vpriv is manufactured.
Shire says on its site that its drug does not require gene manipulation, but Genzyme said this was incorrect because Shire’s technology introduced a gene activator sequence adjacent to a gene that was clearly gene manipulation.
The claim at issue stated that the manufacture of VPRIV ‘does not require gene manipulation’ and in that regard the Panel noted that to some readers ‘manipulation’ would mean to manage, influence or in some other way change.
In the Panel’s view activating a gene would influence or change it in some way, and ruled a breach of the Code.
Shire also claims that its human genetic therapies were “free of animal components, thus minimising the risk of viral contamination”. But Genzyme said this was not the case, and said this claims was ‘incomplete, unbalanced and inaccurate’.
The PMCPA agreed, and said and considered that the claim implied that, in Shire’s human genetic therapies, there was a minimal risk of contamination with any virus, animal or human.
Not introducing animal components in to the manufacturing process had no impact on the risk of contamination with human viruses, the Panel said. The claim was misleading and a breach of the Code was ruled.
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