By Rob Stein
Washington Post Staff Writer
Tuesday, May 30, 2006
The words "It's frustrating," shaped to look like a pair of legs, float across the screen. A voice intones: "It's frustrating. Just when you're ready to relax, you feel the compelling urge to move." Eventually, the legs morph into those of a woman, draped lazily across a recliner.
The television ad, and similar ones appearing in magazines and on the Internet, are hawking the first pill approved to treat a once-obscure condition known as restless legs syndrome, or RLS, which causes an irresistible, sometimes debilitating urge to move.
Praised by some neurologists and patients advocates for raising the profile of an under-diagnosed, under-treated condition, the ads are also raising concerns. Although RLS is a bona fide condition that can make victims miserable, skeptics fear that fidgety people who simply have a hard time sitting still, or twitch a little in their sleep, will receive the inappropriate diagnosis of a serious neurological condition requiring treatment with a powerful prescription medication.
The debate has focused attention on what some have dubbed "disease-mongering" -- taking something that is within normal bounds and labeling it a disease needing pharmaceutical treatment.
"We're increasingly turning normal people into patients," said Lisa M. Schwartz of Dartmouth Medical School.
Shy people have "social phobia," requiring psychotropic drugs. High-strung boys have attention deficit disorder and need amphetamines. Baby boomers with slightly elevated blood pressure have "pre-hypertension" and line up for beta blockers. A few nights of restlessness calls for sleeping pills.
"The ordinary experiences of life become a diagnosis, which makes healthy people feel like they're sick," Schwartz said.
"It's not unique to restless leg syndrome," said Steven Woloshin, another Dartmouth professor who works with Schwartz at the Veterans Affairs Outcomes Group in White River Junction, Vt. "It's just following the template for disease mongering."
RLS is a collection of symptoms that has been recognized as a neurological condition since the 1940s. Victims frequently experience an overwhelming urge to move their legs, often at night, sometimes accompanied by a vague itchy, tugging or "creepy-crawly" sensation. Many sufferers jerk involuntarily while sleeping, disturbing not only their own rest but their spouses'. The symptoms are sometimes so intense they severely limit victims' lives -- precluding jobs that require long meetings or long plane rides, for instance. RLS can be so disruptive that sufferers are disabled by sleep deprivation. Including milder forms, it may affect 3 to 15 percent of the population.
The condition appears to run in families, and the cause is unknown. But neurologists for years have treated severe cases with drugs developed originally for Parkinson's disease, a progressive, crippling and eventually fatal disorder that causes involuntary muscle movements. The drug boosts levels of a chemical signal in the brain called dopamine.
Last year, GlaxoSmithKline Inc. of Research Triangle Park, N.C., won approval for the first time to sell one of these drugs, Requip, specifically for RLS. The company spent about $27 million to advertise the drug for that purpose in 2005, according to TNS Media Intelligence, which tracks advertising. Since the Food and Drug Administration approval, and the ensuing advertising campaign, U.S. sales of the drug have jumped from $97 million to $146 million.
Supporters say the campaign has been positive, educating the public about a condition doctors frequently miss, leaving victims to suffer or have other conditions diagnosed and subjected to futile, perhaps dangerous, mistreatments.
"There's still people out there who have the condition and don't know that they have it," said Georgianna Bell, executive director of the Restless Legs Syndrome Foundation, an advocacy group based in Rochester, Minn., that gets about $450,000 in funding from GlaxoSmithKline. "It's a serious condition. Raising awareness is important. It can help a lot of people."
The worst that can happen is that patients may try the drug to see if it helps. If not, they simply stop taking it, said David Rye, a neurologist at Emory University in Atlanta and chairman of the foundation's medical advisory board.
"I don't know of any evidence that it's being over-diagnosed," Rye said. "I look at the positive side of it rather than the doomsday view. I think it helps to make a diagnosis."
Frank Stevens of Gillette, Wyo., realized he might have a problem after spotting a Requip ad on TV.
"When I saw the ad, it pretty much described me to a tee," said the 57-year-old lawyer, who is trying iron supplements first to see if they alleviate his symptoms. "If that doesn't do it, then I'll talk to my doctor about trying something else."
Critics acknowledge they have no direct evidence that the drug is being misused. But they say the jump in sales suggests it is. They point to the vague definition in the company's advertising, which could easily lead people to confuse ordinary fidgetiness with the condition.
"The problem is there is this vast gray zone of symptoms that most people wouldn't experience as symptoms but just experiences of ordinary life," Woloshin said. "The problem is, where do you draw the line?"
The drug, which costs about $169 for a three-month supply, can cause side effects, including nausea, dizziness and, ironically, daytime sleepiness, Woloshin noted. No long-term studies have been done to see whether more serious side effects occur with years of use, he said.
"People might take this for years -- even a lifetime," Schwartz said.
Some neurologists also worry that the ads may be doing a disservice.
"I think they are more confusing than beneficial," said Cynthia L. Comella of Rush University Medical Center in Chicago. "Patients are going to be asking for a drug they shouldn't get. Unless a physician is very well informed about RLS, they may make a misdiagnosis."
Researchers say it is surprisingly easy for patients to persuade doctors to prescribe medications, especially for unfamiliar conditions.
With restless legs syndrome, "physicians don't know much about it and may be wanting to follow the path of least resistance and prescribe a medication for a condition that a patient might not have," said Richard Kravitz of the University of California at Davis, who studies how drug ads influence doctors and patients.
Other researchers are concerned that patients may be suffering from non-RLS conditions that will go undiagnosed.
GlaxoSmithKline defends its marketing, saying that the drug is clearly labeled as being only for patients with moderate to severe RLS, and that the ads recommend patients try other measures first.
"Our focus is on helping patients who struggle with illness, and we're proud of the progress we've made in addressing their needs," said spokeswoman Mary Anne Rhyne. "There's important information on our product label to inform physicians as to whether or not a product is appropriate."
But critics remain skeptical.
"The argument the pharmaceutical industry is always making is that this is patient education -- that this is an under-diagnosed condition and 'we're just trying to raise awareness,' " said Michael Wilkes of the University of California at Davis. "If you're talking about something like hepatitis C or measles, that might be true. But if you're talking about toenail fungus or baldness or restless leg syndrome, I just don't buy it."