By FEDERICA NARANCIO
Observer staff
April 16, 2008

As a child, Sherry Dagnall said she never caused her parents trouble – except during bedtime. Instead of getting adequate rest, she had the uncontrollable urge to move her legs and walking was the only way to relieve this urge. As Dagnall grew older, her symptoms worsened and the compulsion to move her legs whenever she was at rest made her sleep-deprived and exhausted.

“No one understood that there was something wrong with me,” Dagnall said. “When I had a hard time waking up after I finally went to bed, people said I was lazy and irresponsible.”

Dagnall said she spent nine years looking for medical help. In the meantime, she was misdiagnosed with chronic fatigue syndrome and lost her job at a hospital because her sleep deprivation affected her concentration at work. She also spent countless nights awake, and recalls that once she spent an entire week without sleeping because her doctor tried to switch her medications.

In 1993, a doctor was able to diagnose what she had – restless legs syndrome (RLS). This neurological condition, characterized by a compulsive need to move the legs, severely affects 3 percent of Americans and up to 10 percent have moderate-to-mild symptoms, according to the Restless Legs Syndrome Foundation, a nonprofit organization that aims to increase awareness of RLS. On average, 7.5 percent of Americans suffer from this condition, said Dr. Christopher Earley, a neurologist specializing in sleep disorders at Johns Hopkins Bayview Medical Center in Baltimore.

Comedian Jon Stewart makes fun of the TV ad for RLS drugs in The Daily Show.

The cause of restless legs syndrome is still unknown, and there is no known cure. The treatment to reduce the symptoms varies according to each patient. For those who have mild symptoms, moderate exercise, reducing the consumption of alcohol, tobacco and caffeine and having a healthy diet might help, but not always. Most of the people interviewed for this report said the combination of non-drug and drug treatments helped them cope with the uncontrollable urge to move their legs.

However, patients like Dagnall who have moderate-to-severe symptoms have to avoid certain activities. Going to the movies, airplane flights and car trips are “torture,” Dagnall said. To undergo medical tasks such as attending the dentist, she has to take extra medication to be able to sit through it.

Lynne Kaiser, 44, who has severe restless legs syndrome, said she often has to ask people what day it is and forgets to go to appointments or to pick up her children from school because of sleep deprivation. She said she keeps four calendars in the house to keep track of time.

“You are so exhausted after two to three days without sleeping that you forget to do the simplest things,” she said. “It is a condition that affects your family and your life. I can’t tell you the mother and the wife I would have liked to be.”

TV ads spark a controversy

Even though RLS is a neurological condition that more people know about these days, those who suffer from it said they still get mocked by friends and colleagues who do not believe it is a real disease.

Part of the reason for this, according to Dagnall, is that the name restless legs syndrome “sounds funny” and the symptoms are so vague to describe people don’t regard it as serious enough.

“The most common misconception about RLS is that it is just a leg-shake,” Dagnall said. “People who have RLS but weren’t diagnosed until recently have been told that there is nothing wrong with them, that it is all in their head and that they have some kind of mental condition.”

The TV ads for Requip and Mirapex – two drugs approved by the FDA for the treatment of RLS in 2005 and 2007, respectively – were a double-edged sword. They raised awareness of the condition but also encouraged more people to make fun of the disease, according to RLS patients interviewed for this report.

The TV ads also sparked a controversy over whether pharmaceutical companies were trying to generate excessive demand for the drugs.

Consumer Reports, a consumer advocate group, published on Nov. 1, 2007, an online video that analyzed the advertisement for Requip. Reporter Jamie Hirsh stated that the ad showed how pharmaceutical companies try to increase their market share by making more consumers believe they have this condition.

Hirsh also warned in the video that the side effects mentioned in the ads – an increased need for gambling and sexual activity – are not a “joke” as many people might think. According to Hirsh, a Mayo Clinic study reported that drugs like Requip and Mirapex are linked to compulsive gambling.

“In fact, two people who had no prior history of gambling lost more than $100,000 each,” she said.

Although the video was praised by some viewers who commented on the Web site, most of those who have restless legs syndrome were very critical and thought the tone of the report trivialized the seriousness of this condition.

“Consumer Reports did a terrible thing when they reported so badly and made fun of the Requip commercial,” said Ed Muffin, 72, who has suffered from RLS since childhood. “If they had talked only about the procedures the drug company used, which I think is true to some extent, but they had to go in and make fun of the disease itself. That got the ire of all people who have RLS.”

Regarding the side effects, Dr. Earley said the drugs can lead to an increased compulsive behavior, but he still prescribes Mirapex and Requip to his patients because they are the most effective ones for the treatment of RLS if used correctly.

Ronni Sandroff, head editor for the health coverage of Consumer Reports, said the video was never intended to target the condition. Instead, she said, it is meant to analyze how the advertising campaign of certain drugs might boost their popularity even among people who don’t need it.

“We are doing a video series and in general we are looking at ads that we feel are not telling the whole story and are confusing to people,” she said. “In the ad for Requip, for instance, we noticed that the description of the symptoms is very vague and can make a lot of people feel they have this problem when it is not that common.”

“It was not our intention at all to target the disease. We do say this is a real syndrome and a real problem,” she added.

But an overwhelming majority of the approximately 150 comments on the Web site said the video was condescending and mocked the condition itself.

“I am against marketing of pharmaceuticals directly to the general public and I am delighted that [Consumer Reports] discourages this practice,” Peter Fotinakes, a neurologist that specializes in sleep disorders, said in a post at the Web site of Consumer Reports. “Unfortunately, I was appalled at how [Consumer Reports] chose to present their point. In a zealous effort to ridicule pharmaceutical and advertisement they also trashed a well recognized, debilitating disease.”

When the symptoms get worse

Dr. Earley had a different perspective on whether the ads for Requip and Mirapex were controversial. He said that although they helped to raise awareness, advertising a drug without properly educating physicians on its use can lead them to prescribe the drug or increase the dosage when unnecessary.
When he started working at Johns Hopkins in 1991, he saw in clinical studies that symptoms of restless legs syndrome in patients being treated with Sinemet, a drug originally used to treat Parkinson’s disease, worsened in a very short time span.

“Patients got used to the initial dosage of Sinemet and as we increased the dosage the symptoms worsened. With my colleague we took the bold move of withdrawing the medication from our patients and their symptoms went back to normal. But we had to look for alternative treatment because they could no longer take Sinemet,” he said.

This is how he and his colleague coined the term “restless legs syndrome augmentation,” which means that patients taking Sinemet got used to the initial dosage, but if the dosage was increased the condition deteriorated.

Earley said that Mirapex and Requip also cause RLS augmentation because, like Sinemet, they are dopamine agents. Dopamine agents are the most effective way to treat RLS, but doctors have to be aware that the dosage cannot be increased, Earley explained.

Today, he said, most of the patients that come to his clinic have also developed augmentation from Mirapex and Requip, because previous physicians unknowingly increased the dosage.

“If a person comes to my clinic from scratch, that is, they haven’t taken any medication yet I would still recommend them to take Mirapex or Requip and keep it in a low dosage. But those who developed augmentation can’t take it anymore because the drug can’t be reinstituted and the symptoms will worsen again,” he said.

“The commercialization of these drugs creates an environment of awareness but the average physician is not adequately provided with education about it,” Earley said. “We want the ABCs, how to give this drug, specific things to avoid, when should one stop. This is what I always explain in my lectures.”