GSK: no Votrient Code breaches
pharmafile | November 4, 2013 | News story | Medical Communications, Sales and Marketing | GSK, PMCPA, Pfizer
GlaxoSmithKline has been cleared of any wrongdoing over the promotion of its renal cell carcinoma drug Votrient after complaints by Pfizer, which manufactures the rival treatment Sutent.
Pfizer complained that a leavepiece for Votrient (pazopanib) breached multiple clauses of the ABPI Code of Practice – but the PMCPA, which enforces the code, disagreed on all counts.
The background to the case is that Votrient proved itself non-inferior to Sutent in terms of progression-free survival (PFS) in the open-label, head-to-head Phase III study COMPARZ.
Sutent is still the market leader but Votrient is challenging hard, and will usurp Sutent by 2016, according to analysts at Decision Resources.
The promotion in question was titled ‘New data – COMPARZ study’ and Pfizer pointed out that the leavepiece presented several analyses of data and claimed that pazopanib was non-inferior to sunitinib in terms of PFS – but it was not clear that the intention-to-treat (ITT) population was used to provide the PFS comparison.
Although the ITT population met the pre-defined criteria for non-inferiority, Pfizer said, the per protocol (PP) analysis did not.
Pfizer’s allegation was that by presenting only the ITT analysis in the leavepiece but not labelling it as such, GSK had been misleading – both the ITT and the PP analyses should be presented in all promotional materials.
In its judgment, the PMCPA found that GSK had not made the most serious breach of the Code (clause 2, which deals with bringing discredit upon, or reducing confidence in, the pharma industry).
Its investigating panel also decided that the manufacturer had also stayed within the rules on four parts of clause 7, which deals with information, claims and comparisons.
These were 7.2 and 7.3 (on misleading use of data), 7.4 (the substantiation of claims) and 7.8 (the use of graphs and tables).
Th panel said: “Although it would have been helpful to explicitly refer to the ITT population on page 4, on balance the failure to do so was not misleading.” Therefore no breach was ruled.
Since the primary ITT analysis and the PP analysis were so similar, it was not misleading to refer only to the ITT analysis – hence no breach again.
Finally, the PMCPA panel also considered that the claims of Votrient’s non-inferiority of Votrient versus sunitinib could be backed up, which meant GSK had not fallen foul of the Code.
Pfizer appealed against the PMCPA’s ruling but was not successful. The result is published in the November 2013 Review.
Adam Hill
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