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PMCPA Case

AUTH/2147/7/08: GlaxoSmithKline v Sanofi Pasteur MSD – Gardasil press release and PR agency emails

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2147/7/08
Case referenceGlaxoSmithKline v Sanofi Pasteur MSD
ComplainantGlaxoSmithKline UK Ltd
Respondent/companySanofi Pasteur MSD
Product(s)Gardasil; Cervarix
Material/channelPress release (issued 18 June 2008; also on website; issued to consumer press); PR agency emails (press release email on 18 June; press coverage summary email following day)
Key issueMisleading, unsubstantiated and exaggerated claims (including implied superiority and “vaccine of choice” claims), reliance on footnotes, disparagement of DoH decision/Cervarix, and encouragement of the public to request a prescription-only medicine; governance concerns over agency communications without company copy approval
Dates (received/completed if stated)Complaint received 22 July 2008; Case completed 22 September 2008
AppealNot stated
Code year2006 Code (considered under the 2006 Code using the 2008 Constitution and Procedure)
Breaches/clausesBreaches: 7.2, 7.4, 7.10, 8.1, 8.2, 20.2, 9.1. No breach: 9.9, 3.2, 2.
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

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

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What happened

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  • GlaxoSmithKline (GSK) complained about a Sanofi Pasteur MSD press release titled “School girls in the UK will not benefit from the World’s leading four type human papillomavirus (HPV) vaccine, Gardasil”, issued on 18 June following the Department of Health (DoH) announcement to use Cervarix for the national HPV immunisation programme instead of Gardasil.
  • GSK also complained about activities undertaken on behalf of Sanofi Pasteur MSD, including PR agency emails: one sending the press release on 18 June and another sending a summary of press coverage the following day.
  • GSK alleged multiple claims were misleading/exaggerated and/or unsubstantiated, including: “unmatched cervical cancer protection”; statements implying protection for vaginal pre-cancerous lesions linked to a CHMP positive opinion; “vast majority” wording about HPV types and cervical cancer; and “vaccine of choice”/tender and doctor preference claims relying on footnotes.
  • The Panel considered the context: Cervarix and Gardasil were the only two vaccines licensed for prevention of cervical cancer, and there was no head-to-head data to establish clinical superiority.
  • The Panel also considered distribution: the press release had been issued to the consumer press; and the PR agency emails were sent to health professionals who, per Sanofi Pasteur MSD’s submission, had an existing relationship and were in some capacity acting as consultants.
  • The Panel noted with concern Sanofi Pasteur MSD’s submission that emails had been sent by its PR agency without formal copy approval by the company, stating this was wholly unacceptable and that companies could not delegate Code responsibilities to a third party.
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Outcome

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  • Breaches were ruled for the “unmatched cervical cancer protection” claim (misleading, unsubstantiated, exaggerated).
  • A breach was ruled where the press release implied Gardasil was authorised for protection from pre-cancerous vaginal lesions (it was not), and for ambiguous/exaggerated wording about HPV types causing the “vast majority” of cervical cancer.
  • Breaches were ruled for tender/usage/doctor preference claims that were misleading, relied on footnotes for essential clarification, were exaggerated, and could not be substantiated as presented; the Panel also ruled these claims undermined the DoH’s choice of Cervarix and thus disparaged both the product and the DoH.
  • A breach was ruled for issuing the press release to the consumer press in a way that would encourage members of the public to ask their health professional to prescribe Gardasil.
  • No breach was ruled for the allegation that the PR agency emails to health professionals were unsolicited promotional material (Clause 9.9), on the basis that recipients appeared to be, in some capacity, acting as consultants to the company.
  • A breach was ruled for failure to maintain high standards (Clause 9.1). The Panel did not rule a breach of Clause 2 (particular censure).
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