AUTH/2131/6/08: Community pharmacist v Grünenthal Ltd – promotion of Versatis and use of interim comparative data

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Key facts

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Case number	AUTH/2131/6/08
Case reference	Community Pharmacist v Grünenthal
Complainant	Community pharmacist
Respondent/company	Grünenthal Ltd
Product(s)	Versatis (lidocaine medicated plaster)
Material/channel	Representative call; detail aid (pages 4, 5 and 8 referenced)
Key issue	Use of interim “data on file” and other sources to support 4-week comparative claims vs pregabalin (and alleged comments also referencing gabapentin), including efficacy and adverse events; adequacy of substantiation and risk of misleading promotion
Dates (received/completed if stated)	Complaint received 10 June 2008; Case completed 29 August 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 7.2 (breach); Clause 7.4 (breach); Clause 7.5 (no breach)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A community pharmacist complained about a Grünenthal representative’s promotion of Versatis (lidocaine medicated plaster) during a pharmacy visit in June 2008.
The representative was alleged to have said a study showed Versatis had roughly equivalent efficacy to gabapentin (the complainant later noted it might have been pregabalin), with a much lower incidence of interactions and side-effects.
The complainant asked to see supporting data and was told it was still being worked on and would not be available until September; the representative did not later offer to supply it.
The complaint focused on the use of interim data in a detail aid to support claims such as “Versatis is comparable to pregabalin in patient response at 4 weeks” and similar 4-week efficacy and adverse event comparisons.
The Panel considered pages 4, 5 and 8 of the detail aid, which referenced “data on file” and described results as an “interim analysis” (including p=0.0083) and included bar charts for 4-week outcomes and adverse events.
Grünenthal provided interim substantiation for the 4-week claims consisting of one page (page 53 of 418) with limited study details; it stated the study was a non-inferiority study.
Grünenthal also relied on Hempenstall et al (2005) (a meta-analysis using NNT) and SPC information in its submissions, including for interactions and adverse events.

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The Panel found there was insufficient evidence (on the balance of probabilities) that the complainant had asked for interim data; therefore, no breach was found regarding failure to supply interim data.
The Panel ruled that the interim data provided did not substantiate the claims that Versatis had comparable efficacy to pregabalin at 4 weeks and that the claims were misleading.
The Panel ruled that the 4-week adverse event comparison claims were not substantiated; SPC information was too general to support the specific 4-week comparative claims, and no supporting “data on file” for adverse events was supplied.
The Panel also expressed concerns about whether Hempenstall et al was sufficient to substantiate comparative claims, noting cautions in the publication and differences in dataset sizes not reported in the detail aid, and requested these concerns be drawn to Grünenthal’s attention.

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Clause 7.2 – Breach ruled (comparative efficacy and adverse event claims not substantiated; misleading).
Clause 7.4 – Breach ruled (comparative claims misleading / not capable of substantiation as presented).
Clause 7.5 – No breach ruled (insufficient evidence that interim data had been requested; therefore no breach for failure to supply interim data).

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