Restless Legs Syndrome (RLS) is a relatively new term that has become somewhat ubiquitous following a multi-million dollar ad campaign spearheaded by drug maker GlaxoSmithKline. Given that the US Food and Drug Administration (FDA) has approved generic versions of Requip, RLS may have run its course, according to experts.
In 2005, the FDA approved the first drug for RLS—a twitching condition affecting the legs—launching a new household term, a new designer disorder, and a multi-million-dollar consumer ad campaign. Television ads hyping ropinirole hydrochloride, a drug originally used to treat Parkinson’s disease, sent patients to doctors demanding brand name, Requip. In under a year, Requip sales doubled from $165 million in 2005 to nearly $330 million in 2006. By last year, 4.4 million prescriptions were written, with sales of nearly $491 million, according to IMS health, an industry information agency.
Some call the RLS phenomenon an example of “disease mongering” in which promoters, such as drug companies, deliberately enlarge the market by promoting advertisement and convincing people they’re sick and need treatment. “You may have something that’s a normal condition,” said Dr. Lisa M. Schwartz, associate professor of medicine and community and family medicine at Dartmouth Medical School in Hanover, New Hampshire. “It makes you wonder whether there’s a disease to be treated.” Schwartz and her husband, Dr. Steven Woloshin, also at Dartmouth, say that drug company promotions, combined with uncritical media reporting, exaggerated the prevalence of RLS, leading to over-diagnosis and -treatment with powerful brain-altering drugs.
At least one sleep disorder specialist expects the focus on RLS to fade as rapidly as the Requip television commercials, which have been pulled. “Restless legs syndrome is a great example of a suddenly out-of-the-blue disease,” said Dr. Christopher J. Earley, an associate professor of neurology at Johns Hopkins University in Baltimore who treats RLS. Advertising created an overheated demand for diagnosis among consumers, while samples gave and easy answer for busy doctors, he said. “I would anticipate there would be something of a fall-off,” Earley said.
That prediction alarms patient advocates who welcomed public attention—and all that drug industry funding; however, the generic switch leads to fewer ads, that should decrease patient demand for diagnosis and treatment, leaving only the most serious sufferers to weigh the benefits against potentially severe side effects. Doctors may not be inclined to prescribe the drug if the supply of brand-name samples disappears; generics won’t come with samples.
Ad decline depends largely on the makers of Mirapex, the second-leading drug approved to treat RLS, said Schwartz. “If it ends up that they pull back, the market might go down,” Schwartz said. “It’s usually a pretty sharp drop,” said Glaxo spokeswoman Mary Anne Rhyne.
Though drugmakers portrayed their products as a sure-fire cure for symptoms, the reality isn’t so certain. The range varied considerably in the trials, none of which lasted more than 12 weeks.
And, side effects can be considerable. The biggest problems included debilitating nausea, dizziness, and falling asleep during daily activities and studies link the drugs to compulsions such as gambling or sexual promiscuity. Even when the drugs do work, patients face problems of increased tolerance, which can cause augmentation, in which the drug increases RLS symptoms.
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