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."
