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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) (comparator referenced by complainant)
Material/channelDetail aid (pages referenced: 6, 7, 11; key messages summary/back page)
Key issueAlleged misleading comparative efficacy vs NRT (12-week vs 52-week outcomes), NNT and cost-effectiveness claims (currency/balance of evidence), and safety/prescribing information (MI reporting; tone of safety claim)
Dates (received/completed if stated)Complaint received 15 July 2008; Case completed 29 August 2008
AppealNot stated
Code yearConsidered under the 2008 Constitution and Procedure (clauses cited same in 2006 and 2008 Code)
Breaches/clausesNo breach of Clauses 4.2, 7.2, 7.3, 7.9 (as cited in the case)
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) vs placebo from a Cochrane Review (NNT: all types of NRT 20; bupropion 15; Champix 8). GSK alleged it was not an up-to-date evaluation of evidence following Aubin et al and raised concerns about pooling different NRT types.
  • Page 7 also included a cost-effectiveness subheading and claim: “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 challenged safety messaging including “Favourable safety profile in approximately 4,000 treated smokers” and alleged the detail aid’s prescribing information did not mention post-marketing reports of myocardial infarction (MI) that were included in the Champix SPC.
  • Pfizer responded that the 12-week endpoint was the primary endpoint and that 52-week data (showing non-significance) was included; it argued NNT vs placebo was up-to-date at the time of complaint; it defended the cost-effectiveness claim; and it argued the safety claim and prescribing information met Code requirements.
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Outcome

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  • No breach of Clause 7.2 was ruled regarding the 12-week efficacy claims vs NRT because both 12-week and 52-week data were presented with statistical significance stated, and it was clear the 52-week difference was not statistically significant.
  • No breach of Clauses 7.2 and 7.3 was ruled regarding NNT vs placebo because the data was up-to-date when the complaint was made (updated Cochrane NNT values were published the day after the complaint was received).
  • No breach of Clauses 7.2 and 7.3 was ruled regarding the cost-effectiveness claim; the Panel found no data showing that incorporating later Aubin et al results would change the broad conclusion.
  • No breach was ruled regarding prescribing information and MI: the Panel did not consider the omission of MI from the detail aid prescribing information meant it failed Code requirements for prescribing information, and it did not consider prescribers were unable to make an informed appraisal.
  • During consideration, the Panel queried whether the claim “Favourable safety profile in approximately 4,000 treated smokers” accurately reflected the more qualified tone of the SPC statement, and requested Pfizer be advised of its concerns.
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