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/fesoterodine fumarate); Detrusitol (tolterodine)
Material/channel	Journal advertisements (refs TOV097b and TOV162); TOV162 published in Geriatric Medicine (July 2008)
Key issue	Comparative efficacy claims vs tolterodine ER 4mg based on post hoc analysis; whether claims were misleading/unsubstantiated; whether footnotes could qualify claims; “Article in press” wording
Dates (received/completed if stated)	Complaint received 25 July 2008; case completed 28 October 2008
Appeal	Pfizer appealed (unsuccessful on Clause 7.4 for TOV097b and on Clauses 7.2/7.4/9.1 for TOV162/high standards); complainant appealed on Clause 2 (unsuccessful)
Code year	Considered under the 2008 Constitution and Procedure; clauses referenced as same in 2008 Code as 2006 Code
Breaches/clauses	Breaches: 7.2, 7.4, 9.1. No breach: 2. No breach for “Article in press”: 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 4mg (Detrusitol) in overactive bladder syndrome (OAB).
The advertisements were identified as TOV097b (original; prepared May 2008) and TOV162 (revised; prepared June 2008; published in Geriatric Medicine July 2008).
Both advertisements used the reference status “Article in press” for Chapple et al (2008) to support comparative claims.
The complainant alleged “Article in press” was misleading; and that the comparative claims were misleading and not supported by Chapple et al (2008), including concerns about post hoc analysis and use of a footnote.
Pfizer stated “Article in press” was accurate because Chapple et al (2008) had been accepted on 28 March 2008 and published online on 21 July 2008.
Pfizer stated the initial advertisement TOV097b had been withdrawn (in a separate case) and that the general comparative claim was no longer used.
The Panel considered Chapple et al (2008) to be a post hoc analysis of a phase 3 study (Chapple et al 2007) which included a tolterodine ER 4mg arm as an active control; it noted limitations including that the study was not powered for comparisons between active treatments.

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No breach was ruled for use of the phrase “Article in press” (no breach of Clause 7.2).
The claim in TOV097b (“Toviaz 8mg demonstrated improvements with statistical significance vs tolterodine ER in important treatment outcomes”) was ruled misleading (breach of Clause 7.2) and not substantiated by Chapple et al (2008) (breach of Clause 7.4). Pfizer accepted the Clause 7.2 breach and appealed the Clause 7.4 breach; the Appeal Board upheld the Clause 7.4 breach.
The claim in TOV162 (“Toviaz 8mg was significantly better than tolterodine ER 4mg in improving a number of important endpoints; specifically…”) was ruled misleading (breach of Clause 7.2) and not capable of substantiation (breach of Clause 7.4). These rulings were upheld on appeal by Pfizer.
The Panel (and Appeal Board) ruled that high standards had not been maintained (breach of Clause 9.1), upheld on appeal by Pfizer.
No breach of Clause 2 was ruled; this was upheld on appeal by the complainant.
The Appeal Board noted that the Toviaz SPC recommended a starting dose of 4mg once daily with possible increase to 8mg once daily; it also noted that in Chapple et al (2007) some patients were started on 8mg, which it stated was not in accordance with the SPC.

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Clause 7.2: Breach ruled for misleading comparative efficacy claims in both advertisements (TOV097b and TOV162). No breach ruled regarding the phrase “Article in press”.
Clause 7.4: Breach ruled for lack of substantiation for the comparative claims in both advertisements.
Clause 9.1: Breach ruled because high standards had not been maintained.
Clause 2: No breach ruled (Panel decision upheld on appeal).

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