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PMCPA Case

AUTH/2126/5/08 Procter & Gamble v Servier Laboratories: misleading and disparaging claims about bisphosphonates and acid suppressants

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2126/5/08
Case referenceMisleading and disparaging material about bisphosphonates
ComplainantProcter & Gamble Pharmaceuticals UK, Limited
Respondent/companyServier Laboratories Ltd
Product(s)Actonel (risedronate sodium) (complainant product); Protelos (strontium ranelate) (Servier product)
Material/channelLetter to prescribing advisors (14 Feb 2008; ref 07MKA0006); press release (4 Apr 2008; ref 08MCA0026); sponsored symposium/presentation at BGS meeting, Glasgow (24 Apr 2008)
Key issueUnbalanced/misleading presentation of emerging data about acid suppressants and fracture risk and implied attenuation of bisphosphonate efficacy; disparaging implication about bisphosphonates; concerns about speaker briefing notes including a promotional call to action
Dates (received/completed if stated)Complaint received 9 May 2008; Case completed 23 September 2008
AppealYes. Servier appealed breaches of Clauses 7.2 and 8.1; Appeal Board upheld the Panel’s rulings. Clause 2 no-breach ruling was not appealed.
Code yearNot stated
Breaches/clausesClause 7.2 (breach); Clause 8.1 (breach); Clause 2 (no breach)
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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  • Procter & Gamble Pharmaceuticals UK, Limited complained that Servier Laboratories Ltd disseminated misleading and disparaging information about oral bisphosphonates, including Actonel (risedronate sodium).
  • Materials/activities at issue were: a letter to prescribing advisors dated 14 February 2008 (ref 07MKA0006), a press release dated 4 April 2008 (ref 08MCA0026), and a Servier-sponsored symposium at the British Geriatrics Society (BGS) meeting in Glasgow on 24 April 2008.
  • The communications conveyed messages that acid suppressant medication (including PPIs) had been associated with increased fracture risk, and that epidemiological data suggested bisphosphonate anti-fracture efficacy was potentially attenuated when co-prescribed with acid suppressants.
  • Procter & Gamble alleged the data were limited/contradictory and that Servier’s claims were not balanced, were misleading, and implied bisphosphonates were less effective when co-prescribed with acid suppressants (disparaging).
  • Procter & Gamble also alleged a broader strategy including communications with NICE; it argued the campaign was intended to influence prescribing in Servier’s favour (Servier supplied Protelos (strontium ranelate)).
  • Servier denied the materials were misleading or disparaging and stated that communications with NICE were via the formal consultation process and outside the Code’s scope.
  • At the BGS symposium, the Panel and Appeal Board considered the slides and (notably) the speaker briefing notes; the briefing included a conclusion to consider prescribing strontium ranelate (Protelos) for certain patients.
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Outcome

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  • The Panel ruled breaches of Clause 7.2 (misleading/unbalanced presentation of emerging clinical/scientific opinion) and Clause 8.1 (disparaging references to other companies’ medicines) in relation to the letter, press release, and symposium presentation materials.
  • The Panel did not rule a breach of Clause 2 (discredit to the industry); this ruling was not appealed.
  • Servier appealed all Panel rulings for Clauses 7.2 and 8.1.
  • The Appeal Board upheld the Panel’s rulings: the letter and press release exaggerated the clinical importance of the data and were not balanced; the implication that bisphosphonates were less effective with acid suppressants was disparaging given the existing data.
  • The Appeal Board also upheld breaches for the BGS symposium materials and was extremely concerned about the speaker briefing notes, describing the inclusion of a direct promotional call to action to consider Protelos as wholly unacceptable and a very poor reflection of the company’s procedures.
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