Case Summary
A general practitioner complained that a journal advertisement for Celebrex (celecoxib) issued by Pfizer exaggerated the efficacy of Celebrex (celecoxib) in that the claim ‘I need a treatment that will relieve my pain’ in close association with efficacy claims for Celebrex invited the suggestion of a guaranteed 100% pain relief for all patients. The efficacy data for Celebrex did not support this suggestion.
The Panel noted from the Celebrex summary of product characteristics (SPC) that it was indicated, inter alia, for symptomatic relief in the treatment of osteoarthritis (OA), rheumatoid arthritis (RA).
The Panel considered that the claim ‘I need a treatment that will relieve my pain’ was an aspiration. The claim was immediately followed by a claim that in OA and RA Celebrex was a valuable treatment option. The Panel did not consider that the audience would be misled into thinking Celebrex guaranteed 100% pain relief for all patients. The Panel did not consider the claim misleading, exaggerated or incapable of substantiation as alleged.
No breach of the Code was ruled.
AUTH/2005/5/07 - GP v Pfizer
A general practitioner complained that a journal advertisement for Celebrex (celecoxib) issued by Pfizer exaggerated the efficacy of Celebrex (celecoxib) in that the claim ‘I need a treatment that will relieve my pain’ in close association with efficacy claims for Celebrex invited the suggestion of a guaranteed 100% pain relief for all patients. The efficacy data for Celebrex did not support this suggestion.
The Panel noted from the Celebrex summary of product characteristics (SPC) that it was indicated, inter alia, for symptomatic relief in the treatment of osteoarthritis (OA), rheumatoid arthritis (RA).
The Panel considered that the claim ‘I need a treatment that will relieve my pain’ was an aspiration. The claim was immediately followed by a claim that in OA and RA Celebrex was a valuable treatment option. The Panel did not consider that the audience would be misled into thinking Celebrex guaranteed 100% pain relief for all patients. The Panel did not consider the claim misleading, exaggerated or incapable of substantiation as alleged.
No breach of the Code was ruled.
A general practitioner complained about an advertisement (COX459h) for Celebrex (celecoxib) issued by Pfizer Limited and published in Geriatric Medicine, May 2007.
COMPLAINT
The complainant wondered whether the claim ‘I need a treatment that will relieve my pain’ in close association with efficacy claims for Celebrex invited the suggestion of a guaranteed 100% pain relief for all patients with respect to this medicine and could be regarded as somewhat of an exaggeration regarding the efficacy of Celebrex. The efficacy data for Celebrex did not support this suggestion.
The Authority asked Pfizer to respond in relation to the requirements of Clauses 7.2, 7.4 and 7.10 of the Code.
RESPONSE
Pfizer did not consider the advertisement was in breach. As stated in the summary of product characteristics (SPC), Celebrex was licensed for ‘Symptomatic relief in the treatment of osteoarthritis [OA], rheumatoid arthritis [RA] and ankylosing spondylitis’. Symptomatic relief, to ‘relieve pain’ was a specific aspect of the marketing authorization.
The word ‘relieve’ was defined as ‘alleviate or remove (pain, distress or difficulty)’, and ‘alleviate’ was to ‘make (pain or difficulty) less severe’. The use of the word relieve therefore encompassed the full range of responses, from making pain less severe (by any amount) to complete relief. Therefore even a medicine that would relieve pain would not guarantee 100% pain reduction by any means.
In addition, the statement ‘I need a treatment that will relieve my pain’ was a patient aspiration. A patient who required treatment for their pain was unlikely to be seeking a treatment that ‘might reduce my pain’ or that ‘will partially reduce my pain’. This was followed by the statement ‘In OA and RA, Celebrex was a valuable treatment option’, highlighting that Celebrex was a treatment that deserved to be given consideration in appropriate patients, but certainly did not guarantee 100% efficacy.
The advertisement was further balanced by the inclusion of a statement detailing where to find information on the Medicines and Healthcare products Regulatory Agency (MHRA) website regarding the cardiovascular safety of Cox-2 inhibitors (including Celebrex).
With regard to Clauses 7.2, 7.4 and 7.10, Pfizer submitted that the overall impression and content of the advertisement gave a fair and balanced interpretation of the data for Celebrex, was fully substantiated, and did not exaggerate the properties of the medicine. Patients needed treatments that would ‘relieve their pain’ in OA and RA, and in line with this aspiration, Celebrex was a valuable treatment option.
PANEL RULING
The Panel noted from the Celebrex SPC that it was indicated for symptomatic relief in the treatment of OA, RA and ankylosing spondylitis.
The Panel considered that the claim ‘I need a treatment that will relieve my pain’ was an aspiration. The claim was immediately followed by a claim that in OA and RA Celebrex was a valuable treatment option. The Panel did not consider that the audience would be misled into thinking Celebrex guaranteed 100% pain relief for all patients. The Panel did not consider the claim misleading, exaggerated or incapable of substantiation as alleged. No breach of Clauses 7.2, 7.4 and 7.10 was ruled.
Complaint received 29 May 2007
Case completed 6 July 2007
