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PMCPA Case

Servier found to have made misleading and disparaging claims about bisphosphonates in letter, press release and sponsored symposium

📅 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 February 2008; ref 07MKA0006); press release (4 April 2008; ref 08MCA0026); sponsored symposium/presentation at BGS meeting (Glasgow, 24 April 2008)
Key issueUnbalanced/misleading presentation of emerging evidence about acid suppressants and fracture risk and implied attenuation of bisphosphonate efficacy; disparaging implication about competitor class; 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
AppealServier appealed Panel rulings on Clauses 7.2 and 8.1; Appeal Board upheld breaches; appeal unsuccessful. Clause 2 ruling (no breach) 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 about Servier Laboratories Ltd.
  • The complaint concerned alleged misleading and disparaging information about bisphosphonates, including Procter & Gamble’s Actonel (risedronate sodium).
  • Servier supplied Protelos (strontium ranelate), an alternative to bisphosphonates in osteoporosis.
  • 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.
  • Procter & Gamble alleged Servier conveyed two key messages: (1) acid suppressant medication (including PPIs) had been associated with increased fracture risk; and (2) epidemiological data suggested bisphosphonate anti-fracture efficacy was potentially attenuated when co-prescribed with acid suppressants.
  • Procter & Gamble alleged the campaign was unbalanced, misleading (Clause 7.2) and disparaging to bisphosphonates (Clause 8.1), and also alleged it brought discredit on the industry (Clause 2).
  • Inter-company dialogue had proved unsuccessful.
  • Servier denied the materials were misleading or disparaging and denied a Clause 2 breach.
  • The Panel noted that where an unresolved clinical/scientific issue exists, promotional material must treat it with particular care and balance (supplementary information to Clause 7.2).
  • The Panel considered the quality/tentative nature of the evidence and noted NICE appraisal consultation documents described the evidence as observational and tentative, and that recommendations were preliminary and might change after consultation.
  • For the BGS symposium, the Panel and Appeal Board considered the slides and the speaker briefing notes; the briefing notes included a conclusion to consider prescribing strontium ranelate (Protelos) for certain patients and advised a tone that would lead delegates to a “simple solution”.
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Outcome

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  • Letter to prescribing advisors (ref 07MKA0006): ruled in breach of Clause 7.2 (not balanced/accurate reflection of data) and Clause 8.1 (disparaging implication that bisphosphonates were less effective when co-prescribed with acid suppressants). These rulings were upheld on appeal.
  • Press release (ref 08MCA0026): ruled in breach of Clause 7.2 (not balanced/accurate reflection of data; did not refer to tentative nature acknowledged by NICE) and Clause 8.1 (disparaging implication). These rulings were upheld on appeal.
  • BGS sponsored symposium presentation: ruled in breach of Clause 7.2 (slides not balanced/accurate; presented findings as unequivocal) and Clause 8.1 (disparaging implication). These rulings were upheld on appeal.
  • Clause 2 allegation: the Panel did not consider there had been a breach of Clause 2 (reserved for particular censure); this ruling was not appealed.
  • Servier appealed all Panel rulings of breaches of Clauses 7.2 and 8.1; the appeal was unsuccessful.
  • Complaint received: 9 May 2008. Case completed: 23 September 2008.
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