Smoke and fire in J&J Code breach
pharmafile | August 15, 2012 | News story | Sales and Marketing | Champix, J&J, JJ, Johnson and Johnson, PMCPA, Pfizer
Johnson & Johnson has been censured for breaking the ABPI Code of Practice in printed information about its smoking cessation brand Nicorette.
The PMCPA, which enforces the Code, found J&J guilty of multiple breaches, particularly in relation to the inappropriate use of information, claims and comparisons. The company was also held to have failed to maintain high standards.
The problems started with a leavepiece – printed information that salespeople leave with prospective contacts – for Nicorette Invisi 25mg Patch (transdermal nicotine replacement therapy).
Pfizer, which produces rival brand Champix (varenicline) for smokers who want to quit, was concerned that a table in the material suggested it was safer to continue smoking than to try to stop with Champix.
Next to the words ‘Indicated as a Safer Option to Smoking’ was a green tick (denoting ‘may be suitable’) for the Invisi Patch – but the Pfizer brand had a red cross (‘not recommended’) next to it.
Pfizer said that meant the material was unbalanced (thus breaking Code clause 7.2), misleading (7.3), could not be substantiated (7.4), disparaged varenicline (8.1) and did not demonstrate high standards (9.1) – and the PMCPA panel agreed.
Below the table was a statement: ‘The varenicline SPC [summary of product characteristics] states: “Care should be taken with patients with a history of psychiatric illness…’’’
Pfizer said that since the Nicorette Invisi Patch SPC had a number of special warnings and precautions, the data had been cherry picked in an unfair and imbalanced way.
However, the PMCPA panel said there was no warning in relation to use in patients with a history of psychiatric illness on J&J’s product, and that the statement “reflected the available evidence in relation to the use of the medicines in this patient population”.
No breaches of the Code were ruled in this instance – although the PMCPA did find J&J guilty of three further indiscretions which revolved around the selective use of trial data, including safety information, in the leavepiece.
The company breached clause 7.8 (charts and tables must present a fair and balanced view), 7.9 (inaccurate representation of side effects) and 7.10 (exaggerated claims about a product).
Several of the breach decisions were upheld after an appeal by J&J: the full verdict is published in this month’s PMCPA review.
Adam Hill
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