GSK breach for directing HCPs (and indirectly the public) to a patient group website containing unlicensed and misleading ropinirole messages (AUTH/1801/2/06)

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Key facts

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Case number	AUTH/1801/2/06
Complainant	General practitioner
Respondent	GlaxoSmithKline UK Limited
Issue	Reference in a disease awareness ad to a patient support group website that contained statements about ropinirole in RLS (unlicensed in the UK at the time) and a “safe and effective” message
Product	Ropinirole (Requip); RLS context (anticipated UK licence around April 2006)
Ad placement period	September 2004 to November 2005
Applicable Code year	2003
Clauses considered	3.2, 20.1, 20.2
Findings	Breach of Clause 3.2 and Clause 20.2; No breach of Clause 20.1
Appeal	GSK appealed breaches of Clauses 3.2 and 20.2; appeal unsuccessful and breaches upheld
Complaint received	19 February 2006 (HTML) / 20 February 2006 (PDF)
Case completed	25 May 2006 (HTML) / 26 May 2006 (PDF)
Sanctions	Undertaking received; additional sanctions not stated

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

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A general practitioner complained about GlaxoSmithKline’s (GSK’s) involvement with the Ekbom Support Group (ESG), a patient support group for restless leg syndrome (RLS).
GSK placed a disease-awareness advertisement in the GP press (medical journals) from September 2004 to November 2005, stating there was no licensed treatment for RLS in the UK and suggesting patients might appreciate being made aware of the ESG website.
At the time, GSK’s ropinirole (Requip) was licensed in the UK for Parkinson’s disease; ropinirole was not licensed in the UK for RLS (though licensed for RLS in some other countries and anticipated to be licensed in the UK around April 2006).
The ESG website included a newsletter (October 2005) referencing ropinirole for RLS as licensed in Germany and the US, and the site’s news section referred to an article stating ropinirole was “safe and effective for the treatment of RLS”.
GSK said ESG was independent; it had provided limited non-monetary support (admin support, broadband installation, headed stationery) and had checked the website when the ad was approved (August 2004) but did not recheck during the 15-month campaign.
The concern was that referencing the ESG website in company advertising could indirectly promote ropinirole for an unlicensed indication and expose the public to misleading messages about safety/efficacy in that unlicensed use.

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Breach upheld (on appeal): Clause 3.2.
No breach: Clause 20.1.
Breach upheld (on appeal): Clause 20.2.
The Appeal Board found that by directing people to a patient group website in company advertising, the company becomes “inextricably linked” with the site’s content for Code purposes, even without control or input.
The Appeal Board emphasized that companies must ensure that whenever they refer to patient group websites in advertising, the website content is acceptable under the Code (including ongoing re-checks during a campaign).

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