Healthy Skepticism Library item: 5874
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Publication type: news
Templeton S.
Glaxo's cure for 'restless legs' was an unlicensed drug
The Sunday Times ( UK) 2006 Aug 6
http://www.timesonline.co.uk/article/0,,2087-2300695,00.html
Full text:
The Sunday Times August 06, 2006
Glaxo’s cure for ‘restless legs’ was an unlicensed drug
Sarah-Kate Templeton Health Correspondent
THE pharmaceutical giant Glaxo Smith Kline (GSK) has been reprimanded by an industry watchdog for promoting an unlicensed drug to treat the disputed condition of restless legs syndrome.
GSK ran adverts in doctors’ magazines raising awareness of the previously unrecognised ailment, characterised by cramps, pins and needles and an irresistible urge to move one’s legs.
Some doctors claim the condition, also labelled Ekbom’s syndrome, has been concocted or at least exaggerated to help sell drugs. While patients had previously complained to doctors of leg cramp at night, few had heard of restless legs syndrome before drugs became available to treat the illness.
The GSK ads, which ran between September 2004 and November last year, told doctors the syndrome had a serious impact and suggested referring sufferers to a support group website. The website of the Ekbom Support Group said the GSK drug ropinirole, marketed as Adartrel, was effective to treat restless legs although the drug had no licence for such use in Britain. GSK did not gain a British licence to use the drug for restless legs until April this year. Ropinirole was originally used to treat Parkinson’s disease.
The Prescription Medicines Code of Practice Authority, set up by the Association of the British Pharmaceutical Industry, ruled that GSK broke the authority’s rules by promoting an unlicensed drug. “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 authority said.
GSK admitted giving the Ekbom Support Group administrative help, paying for headed stationery and the installation of broadband access.
Dr Des Spence, the Glasgow GP who raised the complaint, said the case was an example of the way pharmaceutical companies used patient groups to promote a new condition, and then supplied drugs to treat it.
“The Ekbom Support Group was hijacked by GSK to promote restless legs syndrome and the GSK drug ropinirole,” he said. “I am not saying some people do not experience pain and restless legs but claims on the website that it is a widespread and serious condition are disproportionate.”
The Ekbom Support Group says 5% of the population suffer from the condition. Doctors say fewer than 3% experience symptoms on a regular basis and, of them, only a minority require any treatment.
The Ekbom Support Group denies that it has been used by GSK. Its founder Eileen Gill, 75, who has suffered from the syndrome all her life took ropinirole for eight years when it was not licensed for that purpose. She says it was legitimate for her to tell other sufferers that the drug worked.
Gill said the Ekbom Support Group received only minor administrative support from GSK and that it was set up 18 years ago, long before involvement with the company. The group showed no preference for GSK medications, she said.
Dr John Shneerson, director of the sleep centre at Papworth hospital, Cambridge, said the condition was not an invention of the drug industry. “Restless legs syndrome is a real neurological condition. It can prevent sufferers from leading a normal life. Sometimes people cannot read a newspaper, sleep at night or sit down to eat a meal,” he said.
A spokesman for GSK said: “There 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.”
