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GSK found in breach of CoP

Ads directed doctors and patients to website that indirectly promoted unlicensed drug, says PMCPA appeal board

GlaxoSmithKline (GSK) has been found in breach of the UK pharmaceutical industry's Code of Practice for directing health professionals and patients to a support group website which effectively promoted the use of an unlicensed drug to treat restless legs syndrome (RLS).

Between September 2004 and November 2005, the company placed advertisements in the GP press drawing attention to RLS as a condition and advising that patients might like to know about the website for the Ekbom Support Group (ESG), a support group for patients with RLS.

The website contained information about GSK's drug ropinirole, marketed as Adartrel, saying it was safe and effective to treat RLS even though at the time, the drug had no licence for such use in the UK. It was not till April this year that the drug, originally used to treat Parkinson's disease, was given regulatory approval to treat RLS.

The Prescription Medicines Code of Practice Authority (PMCPA), established by the Association of the British Pharmaceutical Industry (ABPI) to enforce the Code of Practice, ruled that GSK `was in effect, directing patients to a website that contained misleading messages about the safety of ropinirole, which might indirectly encourage patients to ask their doctors to prescribe it'.

The regulator said that while material on patient groups' websites were not covered by the Code of Practice, GSK had become `inextricably linked with the content of those sites' by directing both health professionals and patients to them. Although GSK had checked the ESG website at the time the advertisement was approved in August 2004, to ensure that directing doctors to it did not lead to a breach of the code, the PMCPA said the company had failed to recheck the website for updates throughout the 15 months the advertisement ran.

Dr Des Spence, the Glasgow GP and spokesman for the organisation, No Free Lunch, which campaigns against excessive promotion of medicines to doctors, raised the complaint against GSK to the ABPI.

Speaking to PMLive, he described the GSK advertising campaign as ìa way of sidestepping some of the regulation around the promotion of ropiniroleî.

ìIt struck me as an unusual advert,î he said. ìThere's a lot of concern about disease mongering and disease extension and I think this is what this was. It was obviously raising the profile of the condition.î

On its website, the ESG says its aim has always been to 'make the condition (RLS) more widely known to the medical profession and the families of sufferers'.

ìIt is hardly surprising if we mention the fact that dopamine agonists in many instances work when used for restless legs,î it continued.

Dr Spence said that although the ESG was a ìgenuine groupî, it had been manipulated by GSK.

ìThe ESG entered into this in good faith without necessarily understanding the level of financial gain and influence that GSK was seeking,î he commented. ìI don't think they understood the size of the market and the amounts of money that GSK stood to make from ropinirole.î

A spokesman for GSK said: ìThere are strict rules in the pharmaceutical industry code of practice that govern the provision of information on an unlicensed condition and GSK takes these very seriously.î

The case will be published in the forthcoming August edition of the PMCPA Code of Practice Review.

30th September 2008

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