AUTH/2262/9/09: Media/Director v Pfizer — Celebrex study recruitment meeting at five-star hotel (No breach on appeal) | PMCPA Case

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Key facts

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Case	AUTH/2262/9/09
Parties	Media/Director v Pfizer
Product	Celebrex (celecoxib)
Issue	BMJ criticism of GP recruitment/investigator meeting venue/hospitality and lack of disclosure of Pfizer funding; questions about study design and transparency
Meeting details	Half-day Saturday meeting (registration 8.30am; presentations from 9am; finished 1pm for lunch); overnight accommodation and dinner provided for most delegates
Attendees (reported)	BMJ: 35 doctors from 25 practices; PMCPA materials: 37 GPs attended, 34 stayed overnight (3 local)
Costs (reported)	£215.63 per attendee (including study staff/investigators) or £278.01 per delegate
Study funding (reported)	Pfizer provided £26 million for the study
Payments to practices (reported)	One-off £1,000 plus ongoing payments (reported variously as £5 every two months per patient via web portal; and in GP template contract: £5 per month per recruited participant plus £1 per month for prescribing data)
Applicable Code year	2008
Clauses cited	2, 9.1, 9.10, 12.2, 18.1, 18.6, 19.1, 19.3
Panel decision	Panel initially ruled breaches (including Clauses 2, 9.1, 19.1, 19.3) but ruled no breach for disguised promotion and certain other points
Appeal outcome	Appeal successful; Code did not apply to the meeting arrangements; No breach
Complaint received	09 September 2009
Case completed	24 March 2010

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

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A BMJ article (5 September 2009, “In clear sight”) criticised a meeting held at a five star hotel resort (March 2009) to encourage GPs to participate in a major cardiovascular safety study comparing celecoxib (Celebrex) vs non-selective NSAIDs.
The meeting was organised by the study sponsor (a named university) and principal investigator; Pfizer said it did not organise the meeting, did not attend, and had limited advance notice (it learned of the March meeting two days beforehand; it learned of a similar January meeting after it occurred).
The BMJ article alleged the invitation and meeting materials did not mention Pfizer, despite Pfizer providing £26 million for the study; the NHS research ethics committee application indicated Pfizer was the sole funder.
The article described hospitality including dinner and drinks the night before, overnight accommodation, travel reimbursement, and a three-course lunch.
The article also raised concerns about transparency (no Pfizer mention on ClinicalTrials.gov registration; study website/news pieces allegedly omitted Pfizer funding) and questioned aspects of study design (a two-week open-label celecoxib run-in before randomisation).
Pfizer stated the study was required to meet an EMEA/CHMP regulatory commitment following COX-2 safety concerns, and that the university was the legal sponsor under clinical trial regulations; Pfizer funded the study and had observer rights on committees and received progress updates.

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Final outcome (Appeal Board): No breach of the Code — the Appeal Board decided Pfizer was not responsible under the Code for the meeting arrangements; the meeting was the responsibility of the university and the Code did not apply, therefore there could be no breach.
The Appeal Board nevertheless expressed concern about perception of such meetings and about lack of transparency in meeting materials regarding Pfizer’s funding role, advising companies to address Code-related expectations contractually even where arrangements may fall outside the Code.

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