Restless Legs Syndrome

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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." [1]

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. [2]

"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disorder—restless legs syndrome—is keeping Americans awake at night" about an internally funded and, at the time, unpublished study."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. [3]

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." [4] 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 [5]. 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. [6]

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." [7]

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. [8]

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