Restless Legs Syndrome
In a paper on the rise of Restless Legs Syndrome Steven Woloshin and Lisa M. Schwartz note that in 2003 "GlaxoSmithKline launched a campaign "to promote awareness about restless legs syndrome, beginning with press releases about presentations at the American Academy of Neurology meeting describing the early trial results of using ropinirole (a drug previously approved for Parkinson disease) for the treatment of restless legs." 
GSK Hypes the Syndrome
In its initial media release, GSK claimed that "RLS is a potentially debilitating neurological disorder characterized by an uncontrollable urge to move the legs. The condition is characterized by painful or distressing sensations in the legs that are described as creeping or twitching and that occur during rest and are relieved through movement. Because symptoms often appear during rest in the evening or at night, RLS can lead to appreciable sleep disturbances." The media release was listed Christina Corso from the PR company Cohn & Wolfe as one of the two contacts. 
"Two months later, GlaxoSmithKline issued a new press release entitled "New survey reveals common yet under recognized disorder—restless legs syndrome—is keeping Americans awake at night" about an internally funded and, at the time, unpublished study."
In May 2005, the US Food and Drug Administration (FDA) approved ropinirole, which is marketed as Requip, for "to treat moderate to severe Restless Legs Syndrome". The FDA also noted that the drug was first approved in 1997 for the treatment of Parkinson's disease.
"Since then, the restless legs campaign has developed into a multimillion dollar international effort to 'push restless legs syndrome into the consciousness of doctors and consumers alike'," Woloshin and Schwartz wrote. 
How Prevalent is the Syndrome?
In announcing the approval for Requip, the FDA stated that "Restless Legs Syndrome is a condition that affects about ten percent of the population."  Subsequently, mainstream media stories, such as in the New York Times, cited the 10% figure.
Woloshin and Schwartz argue the prevalence figure is substantially overtstated. "The frequently cited 10% estimate came from a study that used a single question to identify restless legs syndrome rather than the four standard criteria . The less stringent definition inflates the estimate because people with other causes of leg symptoms (e.g., leg cramps or diabetic neuropathy) are counted incorrectly as having the syndrome," they wrote. 
They note that a June 2005 study of over 16,000 adults found that only 7% of respondents reported all four diagnostic criteria of any frequency, 5% said they occurred on a weekly basis while 2.7% said they experienced the sytmptoms "at least 2 times per week and were reported as moderately or severely distressing." 
Woloshin and Schwartz believe even the 2.7% figure of those with RLS may be too high due to the sampling methodology. The authors cited an extraordinary 98% response rate to their survey. "Most likely, the authors meant that 98% of individuals who agreed to participate completed the survey. But respondents agreeing to participate in a restless legs study are more likely to have leg-related symptoms than nonrespondents," the argue. 
Other SourceWatch Resources
- Ekbom Support Group
- Patient Groups
- Disease Mongering
- Drug industry
- International RLS Study Group
- Sleep Disorders Australia
- NCBI PubMed: "Clinical characteristics and frequency of the hereditary restless legs syndrome in a population of 300 patients" (Abstract). Research conducted by Winkelmann J, Wetter TC, Collado-Seidel V, Gasser T, Dichgans M, Yassouridis A, Trenkwalder C., Max Planck Institute of Psychiatry, Section of Neurology, Munich, Germany. Results published in Sleep. 2000 Aug 1;23(5):597-602.
- "Restless Legs Syndrome Prevalence and Impact. REST General Population Study" (Abstract). Research conducted by Richard P. Allen, PhD; Arthur S. Walters, MD; Jacques Montplaisir, MD, PhD; Wayne Hening, MD, PhD; Andrew Myers, PhD; Timothy J. Bell, PhD; Luigi Ferini-Strambi, MD. Results published in Arch Intern Med. 2005;165:1286-1292.
GSK Media Releases
- GlaxoSmithKline "Study shows Requip® (ropinirole HCl) improves symptoms of Restless legs syndrome", Media Release, March 31, 2003.
- GlaxoSmithKline, "Restless legs syndrome can significantly impair quality of life", Media Release, April 1, 2003.
- GlaxoSmithKline, "New survey reveals common yet under recognized disorder—Restless legs syndrome—is keeping America awake at night", Media Release, June 10, 2003.
- GlaxoSmithKline, "Large multinational general population study shows that Restless Legs Syndrome is common, under-diagnosed, and can negatively impact sleep and daily activities", Media Release, June 13, 2005.
Other General Articles
- Ian Hall, "Clew gains restless legs brief from GSK", PR Week, March 9, 2004. (Sub req'd).
- Food and Drug Administration, "FDA Approves Requip for Restless Legs Syndrome", Media Release, May 5, 2005.
- "Glaxo drug for restless legs syndrome is approved", New York Times; Sect C: 3. May 6, 2005.
- Steven Woloshin and Lisa M. Schwartz, "Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick", PLoS Medicine, Volume 3, Issue 4, April 2006. (Steven Woloshin and Lisa M. Schwartz are at the Veterans Affairs Outcomes Group, White River Junction, Vermont, United States of America, and the Center for the Evaluative Clinical Sciences, Dartmouth Medical School, Hanover, New Hampshire, United States of America. Funding: SW and LMS were supported by Robert Wood Johnson Generalist Faculty Scholar Awards. This study was supported by a grant from the National Cancer Institute (R01CA104721) and from a Research Enhancement Award from the Department of Veterans Affairs."
- Sarah-Kate Templeton, "Glaxo's cure for 'restless legs' was an unlicensed drug", The Sunday Times, August 6, 2006.
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