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PMCPA Case

AUTH/2142/7/08: GlaxoSmithKline Consumer Healthcare v Pfizer – Champix detail aid

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2142/7/08
Case referenceGlaxoSmithKline Consumer Healthcare v Pfizer
ComplainantGlaxoSmithKline Consumer Healthcare
Respondent/companyPfizer Limited
Product(s)Champix (varenicline); NiQuitin Clear Patch (nicotine)
Material/channelDetail aid (pages referenced: 6, 7, 11; key messages summary page)
Key issueAllegedly misleading comparative efficacy framing (12-week vs 52-week quit rates), NNT and cost-effectiveness claims, and safety/prescribing information (MI reporting) in a Champix detail aid
Dates (received/completed if stated)Complaint received 15 July 2008; Case completed 29 August 2008
AppealNot stated
Code year2008 (clauses cited same in 2006 and 2008 Codes)
Breaches/clausesNo breach of Clauses 7.2, 7.3, 4.2, 7.9 (clauses cited: 4.2, 7.2, 7.3, 7.9)
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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  • GlaxoSmithKline Consumer Healthcare complained about a Champix (varenicline) detail aid issued by Pfizer Limited; GSK marketed NiQuitin Clear Patch (nicotine) and both products were indicated for smoking cessation.
  • Page 6 included claims: “Champix at 12 weeks – significantly higher quit success vs NRT” and “Champix at 12 weeks enables significantly more smokers to quit than NRT”, referenced to Aubin et al (2008).
  • GSK alleged the overall impression was misleading because Aubin et al showed a significant difference at end of treatment (12 weeks) but no statistically significant difference at 52 weeks; GSK argued longer-term results should have greater prominence.
  • Page 7 presented “numbers needed to treat” (NNT) versus placebo from a Cochrane Review (NRT 20, bupropion 15, Champix 8); GSK alleged it was not an up-to-date evaluation of evidence after Aubin et al.
  • Page 7 also claimed “Added benefit of cost-effectiveness” and that “Champix was more cost-effective than NRT patches or bupropion (using indirect and direct comparisons respectively)”, referenced to O’Regan et al (2007); GSK alleged it did not fairly reflect up-to-date evidence.
  • GSK also challenged safety messaging, including “Favourable safety profile in approximately 4,000 treated smokers”, and alleged the detail aid’s prescribing information and safety page did not include post-marketing reports of myocardial infarction (MI) referenced in the Champix SPC.
  • The Panel additionally queried whether the unqualified “favourable safety profile” claim accurately reflected the more qualified tone of the SPC statement and asked that Pfizer be advised of its concerns.
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Outcome

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  • Page 6 quit-rate comparison: No breach of Clause 7.2; the Panel considered 12-week and 52-week data were accurately reported and statistical significance was stated, with 52-week difference clearly not statistically significant (p=0.056).
  • NNT presentation: No breach of Clauses 7.2 and 7.3; at the time the complaint was made (15 July 2008) the NNT data versus placebo was up-to-date; Cochrane updated values were published on 16 July 2008 (after the complaint).
  • Cost-effectiveness claim: No breach of Clauses 7.2 and 7.3; the Panel found no evidence that incorporating later Aubin et al quit-rate data would have changed the broad conclusion of O’Regan et al.
  • Safety claim and prescribing information: No breach of Clause 4.2 and no breach of Clause 7.9; the Panel did not consider omission of MI from the detail aid prescribing information meant it failed Code requirements in the circumstances, and did not consider prescribers were unable to make an informed appraisal.
  • Administrative note: The Panel requested Pfizer be advised of its concern that the “favourable safety profile” claim appeared less qualified than the SPC wording.
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