Healthy Skepticism Library item: 6379

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Publication type: news

Whalen J.
Promotional muscle: How Glaxo marketed an ailment --- An ad blitz turned Requip into a big seller to treat restless-legs syndrome
The Wall Street Journal Europe 2006 Oct 25

Full text:

Promotional muscle: How Glaxo marketed an ailment —- An ad blitz turned
Requip into a big seller to treat restless-legs syndrome

By Jeanne Whalen

25 October 2006
The Wall Street Journal Europe
(Copyright © 2006, Dow Jones & Company, Inc.)

WHEN DRUG GIANT GlaxoSmithKline PLC launched a new medicine for
restless-legs syndrome last year, few people had heard of the
affliction, and some physicians were skeptical that it even existed.

Today, the drug, Requip, is on track to post sales of $500 million this
year, making it one of the fastest-growing drugs in Glaxo’s portfolio.

Behind Requip’s surprising sales boom is Glaxo’s marketing machine,
which has convinced many consumers and physicians to accept RLS as a
real condition warranting treatment. Glaxo began its blitz by
advertising the disorder to doctors in medical journals months before
the company even had regulatory approval to begin selling Requip for
RLS. Then, it sent a team of specialists to discuss the disease with
general practitioners, who usually see RLS sufferers first. And it so
heavily advertised the drug directly to consumers that some doctors
accuse Glaxo of disease mongering.

Glaxo declined to discuss specifics about its marketing campaign. A
spokeswoman for the company, based in London, said the company is
“sharing medical information on a wide variety of conditions, including
RLS, which is what we see as our mission.”

Pharmaceutical companies, under pressure to find new sales amid pressure
from generic rivals, are seeking to treat an ever-expanding range of
illnesses and to find additional illnesses their drugs can be used to
treat. As a result, they increasingly need to combat skepticism about a
disease, just as Glaxo did with RLS. Novartis AG, for example, which
makes drugs for both attention-deficit disorder and irritable-bowel
syndrome, has used the Internet extensively to overcome doubt and spread
information on the conditions and treatments, Novartis Chief Executive
Officer Dan Vasella said in an interview.

Restless-legs syndrome causes uncomfortable sensations in the legs and
an uncontrollable urge to move. In mild cases, the disorder makes it
difficult for a person to sit still at the theater or on a plane. In
severe cases, it can keep sufferers up all night.

Glaxo didn’t set out to find a drug for RLS. It invented Requip — a
dopamine agonist that regulates the brain chemical dopamine, which is
responsible for controlling body movements — to treat Parkinson’s
disease, which is also related to dopamine and characterized by shaky
limbs. Glaxo realized Requip’s potential in RLS after some doctors began
prescribing it off-label for the disorder.

This year, less than half of Requip’s expected $500 million in sales are
expected to come from Parkinson’s disease; the rest should come from
RLS, Citigroup estimates. Using Requip to treat RLS “has reinvigorated
the franchise,” Citigroup wrote in a recent research report.

And riding on Glaxo’s RLS push, other rivals are following suit.
Germany’s Boehringer-Ingelheim, maker of Parkinson’s drug Mirapex, has
asked the U.S. Food and Drug Administration to approve the drug for
treating RLS. And Belgium’s UCB SA plans to seek RLS approval for its
Parkinson’s drug, too, UCB Chief Executive Roch Doliveux said in an
interview.

Glaxo, the world’s second-biggest drug company by sales after Pfizer
Inc., knew it faced obstacles as it prepared to launch Requip as an RLS
treatment. Glaxo-funded research had shown that many RLS sufferers
bounce around from doctor to doctor for years without a proper
diagnosis, Glaxo says. Skeptical doctors would often dismiss the
afflicted as fidgeters. “This was a disorder that was generally
overlooked by most physicians and individuals,” says John Winkelman, an
assistant professor at Harvard Medical School who treats sleep
disorders.

So even before the FDA approved Requip as a treatment for RLS, Glaxo
began telling doctors about the disorder in 2004 with ads in medical
journals. One in the New England Journal of Medicine in October 2004
showed a woman tossing and clutching her legs in bed. At the bottom was
Glaxo’s logo and the slogan: “GlaxoSmithKline: A Leader in RLS
Research.” Throughout that summer and fall, Glaxo also issued regular
news releases reporting clinical trials showing that Requip calmed RLS
symptoms more than a placebo.

Soon after the FDA approved Requip as an RLS treatment in May 2005,
Glaxo hired an army of sleep-disorder specialists and invited general
practitioners to dinner at fancy restaurants across the U.S. to hear
them speak about Requip, some specialists say.

Philip Becker, medical director of the Sleep Medicine Institute at the
Presbyterian Hospital of Dallas, says he has delivered about a dozen
such talks in Texas. Dr. Becker, who has treated RLS for 25 years, says
he thinks his talks have persuaded some doctors to take the disorder
more seriously and to try Glaxo’s drug.

To accompany this physician blitz, Glaxo began reaching out to consumers
by advertising heavily on television. It spent $36 million on consumer
ads for Requip last year, according to Nielsen Monitor Plus.

The first ads, in the spring 2005, described the symptoms of RLS without
mentioning the drug. “There’s a name for it — restless-legs syndrome.
And if you have it, you’re among the nearly one in 10 U.S. adults who
do,” the ad said, advising viewers to go to a Glaxo-run Web site —
www.restlesslegs.com — for more information. The site provides a
checklist of symptoms that people can print and advises them to take the
list on their next doctor visit. Later ads began mentioning Requip, as
well.

Glaxo notes in its ads that it got the one-in-10 adults figure from an
epidemiological study published in 2000 in the Archives of Internal
Medicine. But some doctors think this estimate is exaggerated. Writing
in April in Public Library of Science Medicine, an online scientific
journal, Dartmouth Medical School associate professors Steven Woloshin
and Lisa Schwartz said the 10% estimate is probably inflated because the
study asked respondents just one question about symptoms. The doctors
pointed to another study that found that 7% of people reported all four
of the standard diagnostic criteria for RLS, and that only 2.7% reported
moderately or severely distressing symptoms.

The U.S. National Institutes of Health, a standard authority on disease
prevalence, says that the “limited studies” that have been conducted
show that anywhere from 2% to 15% of the population may experience
symptoms.

Hoping to better relieve her symptoms, Kathy Page, a human-resources
executive with restless legs in Smithson, Missouri, switched from
Mirapex to Requip. But after a few months, she switched back to Mirapex,
which her doctor prescribes for her off-label. Requip didn’t work for
her, Ms. Page says. But other patients praise Requip, and many say the
Glaxo campaign has made their doctors take their complaints of symptoms
more seriously.

Awareness of the syndrome rose within months of Glaxo’s first TV ads,
says the Restless Legs Syndrome Foundation, based in Rochester,
Minnesota. It had about 2,600 visitors a day to its Web site before the
Glaxo ad campaign. Two months later, about 4,500 people a day were
visiting, says Georgianna Bell, executive director of the foundation.
More physicians have been stopping by the foundation’s booth at medical
conferences, as well, she says.

Glaxo’s latest ads feature “Sue,” a woman who can’t sleep or function at
work because her legs are constantly twitchy. After taking Requip, “I’m
ready for bed and so are my legs,” Sue says. The ad directs viewers to a
new Glaxo-run Web site. Visitors can enter their mailing and email
addresses and answer questions about their symptoms to receive a guide
about the disorder. The site’s privacy policy says Glaxo may use the
information to contact them.