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

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Key facts

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Case number	AUTH/2147/7/08
Case reference	GlaxoSmithKline v Sanofi Pasteur MSD – Gardasil press release and agency emails
Complainant	GlaxoSmithKline UK Ltd
Respondent/company	Sanofi Pasteur MSD
Product(s)	Gardasil; Cervarix
Material/channel	Press release (issued 18 June 2008; also on company website); PR agency emails (press release distribution and press coverage summary)
Key issue	Misleading/exaggerated and unsubstantiated claims (including implied clinical superiority without head-to-head data), ambiguous disease-causation wording, misleading tender/doctor-choice claims relying on footnotes, disparagement of competitor/DoH decision, and POM information encouraging public requests
Dates (received/completed if stated)	Complaint received 22 July 2008; Case completed 22 September 2008
Appeal	Not stated
Code year	2006 Code (considered under the 2006 Code using the 2008 Constitution and Procedure)
Breaches/clauses	Breaches: 7.2, 7.4, 7.10, 8.1, 8.2, 20.2, 9.1. No breach: 3.2, 9.9, 2.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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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 2008 after the Department of Health (DoH) announced it would use Cervarix (GSK) rather than Gardasil (Sanofi Pasteur MSD) for the national HPV immunisation programme.
At issue were: (1) the press release and (2) an email containing press coverage sent by Sanofi Pasteur MSD’s public relations (PR) agency (plus related distribution activity).
GSK alleged multiple claims were misleading/exaggerated and/or unsubstantiated, including: “unmatched cervical cancer protection”; implications about licence status for vaginal pre-cancerous lesions; use of “vast majority” for cervical cancer causation; and claims about tender outcomes and doctor preferences worldwide.
The Panel considered the context and noted there was no head-to-head data comparing Gardasil and Cervarix, and that some claims relied on footnotes for clarification despite Code guidance that claims should stand alone.
The Panel also 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 responsibilities under the Code could not be delegated to a third party.

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Breaches were ruled for misleading, unsubstantiated and/or exaggerated claims in the press release, including the “unmatched cervical cancer protection” claim.
Breaches were ruled for misleading implications about Gardasil being authorised for protection from pre-cancerous vaginal lesions.
Breaches were ruled for ambiguous/exaggerated disease-causation wording (including use of “vast majority” for 70% or 75%).
Breaches were ruled for misleading/unsubstantiated claims about tender awards and doctor choice, including reliance on footnotes and overbroad “worldwide” claims based on limited-country data.
Breaches were ruled for disparaging Cervarix and undermining/disparaging the DoH’s choice of vaccine.
A breach was ruled for encouraging members of the public to ask for a prescription-only medicine (press release issued to consumer press with statements such as “World’s leading four-type HPV vaccine” and “unmatched cervical cancer protection”).
No breach was ruled for alleged unsolicited promotional emails to health professionals (Clause 9.9), on the basis that the 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). No breach of Clause 2 was ruled.

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Clause 7.2 – Breached (misleading claims including “unmatched cervical cancer protection”; implication of authorisation for vaginal pre-cancerous lesions; ambiguous “four HPV types… together cause the vast majority of cervical cancer”; tender/usage/doctor-choice claims relying on footnotes and lacking clarity).
Clause 7.4 – Breached (claims could not be substantiated; Panel did not consider confidential data not provided to the complainant; tender/doctor-choice claims).
Clause 7.10 – Breached (exaggeration, including “unmatched” and use of “vast majority” for 70%/75%; worldwide doctor-choice claim).
Clause 8.1 – Breached (claims undermined the DoH’s choice of Cervarix and thus disparaged both the product and the DoH).
Clause 8.2 – Breached (as above, disparagement/undermining DoH choice).
Clause 20.2 – Breached (press release to consumer press would encourage patients to ask for the medicine).
Clause 9.9 – Not breached (emails to health professionals were not considered unsolicited promotional material on the basis described by the Panel).
Clause 9.1 – Breached (high standards had not been maintained).
Clause 3.2 – Not breached (Panel ruled no breach on narrow grounds that Clause 3 relates to promotion and a press release should not be promotional).
Clause 2 – Not breached (Panel did not consider the circumstances met the particular censure threshold).

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