AUTH/1938/1/07: GlaxoSmithKline v Sanofi Pasteur MSD — Gardasil journal ad claims (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/1938/1/07
Complainant	GlaxoSmithKline UK Ltd
Respondent	Sanofi Pasteur MSD Ltd
Product	Gardasil (Human Papillomavirus Vaccine (types 6, 11, 16, 18) (Recombinant absorbed))
Material	Double-page journal advertisement (ref 10/06 09214c) in Doctor
Main issues	Alleged misleading/exaggerated cervical cancer prevention claim; alleged ambiguity/misleading proximity of “Benefit from 4 types”; alleged implication that each HPV type caused each listed condition
Applicable Code year	2006
Complaint received	02 January 2007
Case completed	06 March 2007
Appeal	No appeal (but Panel’s breach finding on one point was superseded by an Appeal Board ruling in separate case AUTH/1927/12/06)
Final outcome	No breach
Clauses cited	7.2, 7.4, 7.10

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

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GlaxoSmithKline complained about a double-page journal advertisement for Gardasil (ref 10/06 09214c) published in Doctor, promoted by Sanofi Pasteur MSD.
The ad included the headline claim: “Now there’s Gardasil a vaccine that can prevent cervical cancer”.
The ad also included: “Benefit from 4 types – before and beyond cervical cancer”, positioned immediately below the headline.
A further claim stated: “Beyond the cervix, Gardasil can also prevent vulval pre-cancers and genital warts and reduce the incidence of vaginal pre-cancers caused by human papillomavirus types 6, 11, 16 or 18”.
GSK alleged the cervical cancer prevention claim overstated scope (implying protection against all high-risk HPV types rather than HPV 16/18) and that the “4 types” claim was ambiguous/misleading by proximity; it also alleged the “beyond the cervix” claim implied each HPV type caused each condition.
Sanofi Pasteur MSD stated the ad reflected the licensed indication/SPC and noted the ad had been pre-vetted by the MHRA (while acknowledging this did not guarantee Code compliance).

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No breach of the Code (final outcome).
Claim “Now there’s Gardasil a vaccine that can prevent cervical cancer”: No breach of Clauses 7.2 and 7.10.
Claim “Benefit from 4 types – before and beyond cervical cancer”: Panel initially ruled a breach of Clause 7.2 due to ambiguity/misleading presentation, but this was superseded by the Appeal Board ruling in a separate case (AUTH/1927/12/06) which found no breach; therefore no breach in this case.
Claim “Beyond the cervix…”: No breach of Clause 7.2.

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