Pfizer: Toviaz journal advertisements—misleading comparative efficacy claims vs tolterodine ER

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Key facts

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Case number	AUTH/2150/7/08
Case reference	Toviaz journal advertisements
Complainant	General practitioner
Respondent/company	Pfizer Limited
Product(s)	Toviaz (fesoterodine fumarate); Detrusitol (tolterodine)
Material/channel	Journal advertisements (TOV097b and revised TOV162; published in Geriatric Medicine July 2008)
Key issue	Comparative efficacy claims vs tolterodine ER presented as statistically significant/superior, based on post hoc analysis not powered for between-active comparisons; use of footnote and an additional dosing statement that did not apply to the cited study
Dates (received/completed if stated)	Complaint received 25 July 2008; case completed 28 October 2008
Appeal	Pfizer appeal unsuccessful (breaches upheld); complainant appeal for Clause 2 unsuccessful (no breach upheld)
Code year	2006 Code clauses referenced as same in 2008 Code; case considered under 2008 Constitution and Procedure
Breaches/clauses	Clause 7.2 (breach); Clause 7.4 (breach); Clause 9.1 (breach); Clause 2 (no breach); “Article in press” point: no breach of Clause 7.2
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 general practitioner complained about two Pfizer advertisements for Toviaz (fesoterodine) comparing efficacy with tolterodine ER (Detrusitol) for overactive bladder syndrome (OAB).
The advertisements were: an original ad (ref TOV097b, prepared May 2008) and a revised ad (ref TOV162, prepared June 2008; published in Geriatric Medicine July 2008).
Both ads cited Chapple et al (2008) as an “Article in press”.
The complainant challenged (a) the use of “Article in press” and (b) two comparative claims implying statistical significance/superiority of Toviaz 8mg vs tolterodine ER 4mg, including a revised claim accompanied by a footnote.
The revised ad’s footnote stated: “Analysis of Toviaz 8mg vs tolterodine ER was not part of the original study plan. Starting dose 4mg titrated up to 8mg for more efficacy”.
Pfizer stated the original ad (TOV097b) had been withdrawn (in a separate case) and that the general comparative claim was no longer used.

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“Article in press”: No breach; the Panel considered it acceptable because Chapple et al (2008) had been accepted for publication (March 2008) and readers would understand it was to be published.
Comparative claims vs tolterodine ER: Breaches were ruled for misleading and unsubstantiated claims in both advertisements.
High standards: The Panel ruled (and the Appeal Board upheld) that high standards had not been maintained.
Clause 2: No breach; both the Panel and the Appeal Board considered the circumstances did not warrant Clause 2 censure.
Appeals: Pfizer’s appeals against breaches (including Clause 7.4 and 9.1) were unsuccessful; the complainant’s appeal seeking a Clause 2 breach was unsuccessful.

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Clause 7.2 (misleading claims): Breach (comparative claims in TOV097b and TOV162).
Clause 7.4 (substantiation): Breach (comparative claims in TOV097b and TOV162).
Clause 9.1 (high standards): Breach (overall).
Clause 7.2 (use of “Article in press”): No breach (as ruled in the report).
Clause 2: No breach (reserved for particular censure; not warranted here).

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