Pound Pup Legacy

Every few years, it seems, there’s a new diagnosis for a controversial disease or condition.

Are ADHD, restless leg syndrome (RLS) and fibromyalgia, to name a few disorders du jour, imaginary, or do these labels identify conditions that are all too real for people suffering from them, with symptoms ranging from irritating to debilitating?

The controversy is fueled by the observation that there seems to be a money trail attached to some of the attention for the most fashionable disorders. As pharmaceutical company critic, psychiatrist and author David Healy notes, “when antidepressants were on-patent and making money, we heard a lot about depression; now that mood stabilizers are making money, we hear a lot about [bipolar].”

Restless leg syndrome: for real?

Rush Limbaugh and Ralph Nader make strange bedfellows, but both have expressed skepticism about restless legs syndrome, a progressive neurological disorder in which people feel an often-irresistible urge to move their legs. The condition worsens at night, disturbing sleep.

Some critics go as far as to claim that RLS doesn’t even exist, but was made up by pharmaceutical companies—with the collusion of doctors, patient advocates and the FDA—in order to sell drugs.

When Janice Hoffman, chair of the RLS Foundation, talks about her experience of the disease, however, her voice breaks. Although she has had a successful career as a senior vice president of Wealth Management at Smith Barney, and before that as a music teacher, she often could not sit still for meetings or concerts and at times has walked for hours at night.

“It feels like there’s a sack of worms in my legs and they are all moving,” she says, “You get an almost panicky feeling and do feel like you’re a bit crazy. You can’t overestimate the havoc this wreaks on work and relationships.

“If you are going to cry ‘Wolf!’” she adds, “Do you honestly think you'd waste it on RLS symptoms? Don't you think you'd come up with something a little more believable?”

Before she read a Johns Hopkins newsletter article on the subject in 1993 and was diagnosed and treated, Hoffman was increasingly sleep-deprived. Walking and working were the only things that stopped the awful sensations.

She still has to arrange her life—aisle seats in the concert hall and on planes, contingencies for meetings, explanations for people who confront her about “poor concert decorum”—to deal with it.

Medicalizing normal behavior?

So is RLS really a disease—or is it a prime example of drug companies making normal behavior into a problem that needs to be medicated?  Most people have felt uncomfortable sitting for long periods and many twitch their legs at night and feel a need to get up. Does that really require medication?

Says Steven Woloshin, senior research associate at the Veterans Affairs Outcomes Group who has written a paper critical of the disorder, “The question is what counts as a disease.  Where do you draw the line between normal and abnormal? Hopefully that line gets drawn where treating people as sick does something good for them.”

Woloshin says the medications for RLS aren’t very effective and that a large percent of the response to them is accounted for by the placebo effect.

As with many disorders—and particularly those that have been criticized as being vague and nonspecific, like fibromyalgia and attention-deficit disorder—stress can play a role in RLS.

Unfortunately, conditions like RLS that involve pain and stress are often susceptible to large placebo effects in medication trials. That may be because such conditions are linked to the dopamine and opioid-containing regions of the brain that are involved in the placebo effect.

Also, because focusing on such disorders can worsen them and distraction can sometimes offer relief, they are easy targets for critics.

Hoffman, however, says that medications have allowed her to lead a more normal life.  “Some people do walk for hours, I choose to take medication instead,” she says, adding that RLS is very different from the normal jittery feeling people get when they sit still for too long.

Research on RLS and drugs

The RLS Foundation—which was founded before medications were approved for the disorder—now gets about one-third of its budget from pharmaceutical companies. “Our goal is to find a cure and I don’t know if that’s the same as the goal of the pharmaceutical companies,” Hoffman says.

But Woloshin counters that pharmaceutical advertising and promotion of the disease by advocates funded by drug companies will prompt people without the condition or with mild forms of it to take medication that carries serious risks.

One class of medications, for example, has been linked with increased risk for compulsive gambling and sexual risk-taking. “I think the whole point of these advertisements is to make people think that what they experience is a disease, that they have RLS,” he says.

Right now, there’s no research to resolve this question: No studies suggest that normal people are getting misdiagnosed with RLS or that people with mild problems that could be resolved by other means are taking medication.

But there is recent research linking several genes with certain aspects of the condition. 

According to David Rye, Professor of Neurology at Emory University who suffers from RLS, and whose research has been funded by the RLS Foundation, “These genes in some way altogether explain about 80% of cases and it could be higher.” About 20–30% of people who have the disorder also have an affected relative.

This is by no means the first study done on the condition. RLS was first diagnosed in 1944 and hundreds of papers have been published on it, according to Rye, who is exasperated by critics who don’t think RLS is real or can require treatment.

Rye notes that RLS has been linked with low iron levels, particularly in a brain region called the substantia nigra, an area also affected by the movement disorder Parkinsonism.

Medications used to treat Parkinsonism are also used in RLS.  If iron levels are found to be low in an RLS patient and can be raised, this can reduce symptoms. Unfortunately, many patients either don’t have low iron or cannot be helped by giving more.

Diagnostic proliferation

Some argue that the act of accepting a diagnosis is itself harmful.

“Screening for [high blood pressure] increases absenteeism because people no longer think of themselves as well,” says Nortin Hadler, M.D., author of Worried Sick: A Prescription for Health in an Overtreated America.

Hadler thinks that people with RLS “probably coped better before they knew what it was.”

Rye vigorously disagrees. “When we found this gene, people were crying and hugging me because they had been told by their doctors for years that they were crazy,” he says.

There is little doubt that diagnosis is expanding in general. For example, the concept of high blood pressure has changedto include a category of “prehypertension” and bipolar disorder (formerly called manic depression) now has subcategories in which one can be diagnosed with the condition without suffering the manic episodes that used to be diagnostic.

While health arguments can be made to favor these changes, the cumulative effect is to make more people sick and potentially in need of medications.

“You would have thought that the people who should help out are doctors and universities who would say, ‘Wait a minute. Don’t believe the hype,’” says Healy, “But academics who should be skeptical are leading the charge instead.”

Healy worries especially about the use of antipsychotic medications—which can actually shorten lifespan—in children and in people with milder disorders now being labeled bipolar, which previously would have gone untreated.

A potential brake on this ever-expanding diagnostic world could be the FDA—but it, too, has allowed the expansion of diagnoses and the approval of drugs that turned out to be more risky than beneficial.

Contributing to the problem of diagnostic proliferation is the fact that drugs cannot be approved for general purposes—they must be tested for a specific disorder.

Woloshin believes that one way to protect patients would be to provide clearer information in drug advertising about exactly what the risks and side effects of particular medications are. He says, “The FDA’s role is hopefully to ensure that drugs that are approved are safe and effective. I don’t think there’s any hope of eliminating direct-to-consumer advertising but the regulations should be changed to require that ads present data on how well the drugs work in a standardized way.”

He suggests a “drug facts box,” similar to a nutrition label, which would be standardized, present risk/benefit information and allow consumers to compare different drugs.

Says Healy, “You want to be careful about a system that makes money out of unhappiness and distress, and is quite happy to mislead people about the nature of what they have and quite happy to put them on medications that won’t do much good."

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URL: http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100198253&page=3