Disease Mongering By Way of Restless Legs

Yesterday during lunch I saw an ad for Mirapex, a “prescription medicine used in the treatment of moderate to severe primary restless legs syndrome (RLS).” The fact that there was such thing as a restless leg syndrome seemed odd to me, so I did some sleuthing. (Maggie, who has in fact discussed RLS over at the Health Care Blog, has some great thoughts on the issue as well.)

 RLS is a “medical condition that is described as an urge to move the legs”—simple enough. The Mirapex website offers a list of question designed to help you diagnose yourself:

• Do you feel a strong desire to move your legs from time to time, often when they make you uncomfortable?
• Do those sensations in your legs occur or get stronger when you are inactive?
• Does moving around or stretching help ease those uncomfortable sensations in your legs?
• Do those uncomfortable sensations feel their worst at night?

Boehringer Ingelheim Pharmaceuticals, the manufacturer of Mirapex, is considerate enough to translate these symptoms into layman’s terms:

People often use words like "burning," "creeping," "crawling," "aching," "tingling," and/or "tugging" to try and describe their symptoms. Many people with restless legs syndrome have difficulty explaining the odd sensations they feel, even when talking to their doctor.

So far it seems that I may have RLS if my (1) legs get uncomfortable after sitting for a while and (2) I have trouble articulating this sensation. By these criteria, most anyone who has uttered the phrase “my leg feels weird” qualifies as an RLS sufferer.

To be fair, no doubt there are people out there who suffer from RLS in some form. But do they all need to be medicated? Even on the Mirapex website one finds an admission that lifestyle changes can do much to improve RLS. Things like stretching, exercising, and eating right all can have an impact. Indeed, according to the National Heart, Lung, and Blood Institute, “lifestyle changes may be the only treatment needed for mild RLS.”

If a medicine is unnecessary, then you are left with no benefit—just risk. And in the case of Mirapex the potential risks are significant. From the drug’s website:

MIRAPEX may cause you to fall asleep without any warning, even while doing normal daily activities such as driving. When taking MIRAPEX hallucinations may occur and sometimes you may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness.

Artificial narcolepsy, hallucination, and nausea, certainly would be enough to make me think twice about Mirapex. But things get worse: Mirapex has a tendency to turn its takers into gamblers (I kid you not.) According to a 2005 study from the Mayo Clinic, Mirapex may cause “compulsive gambling addictions.” A class-action lawsuit has been filed against Boehringer Ingelheim Pharmaceuticals in both the U.S. and Canada on behalf of hundreds of patients who found themselves hooked on gambling.

This may seem like a strange side-effect, but it makes sense: Mirapex reduces tremors and twitches by mimicking the effects of dopamine. Dopamine receptors are associated with “pleasure and reward-seeking behavior”—hence gambling.

This is enough to make anyone think twice about Mirapex or, more generally, about treating RLS through prescription medication—anyone, that is, except the companies that look to profit from RLS drugs.

There is good reason to believe that RLS is an instance of what has been called disease mongering, or “the effort by pharmaceutical companies (or others with similar financial interests) to enlarge the market for a treatment by convincing people that they are sick and need medical intervention.” 

Doctors Steven Woloshin and Lisa M. Schwartz from the Veterans Affairs Outcome Group and Dartmouth Medical School laid out the strategies of disease mongering in a 2006 journal article for the Public Library of Science:

“Typically, the disease is vague, with nonspecific symptoms spanning a broad spectrum of severity—from everyday experiences many people would not even call “symptoms,” to profound suffering. The market for treatment gets enlarged in two ways: by narrowing the definition of health so normal experiences get labeled as pathologic, and by expanding the definition of disease to include earlier, milder, and presymptomatic forms (e.g., regarding a risk factor such as high cholesterol as a disease in itself)”.

RLS is a case of the former, where common experiences are repackaged as medical ailments. But how does a drug company convince people that twitchy legs are a plague? Woloshin and Schwartz spell out the process: in 2003 drug-maker GlaxoSmithKline got the ball rolling by “launch[ing] a campaign to promote awareness about restless legs syndrome, beginning with press releases about presentations at the American Academy of Neurology meeting describing the early results” of trials testing GSK’s “ground-breaking cure” for RLS.

Two months later, a press release followed, “entitled ‘New survey reveals common yet under recognized disorder—restless legs syndrome—is keeping Americans awake at night’ about an internally funded and, at the time, unpublished study.” In 2005, the FDA “gave GSK the green light, approving ropinrole, originally used to treat Parkinson’s disease, for treatment of RLS.” This institutional OK opened the floodgates on “a multimillion dollar international effort” to raise awareness of RLS.

The effect of the media blitz was predictable, with newspaper coverage over-estimating the prevalence of the disease and encouraging diagnosis. Story headlines included “Motion sickness: Restless legs syndrome has long been misdiagnosed and misunderstood; that's about to change” from the WSJ and “Restless legs; uncomfortable and overlooked” from the NYT. In 2006, the FDA approved a second drug to treat RLS, Boehringer’s Mirapex.

Soon the RLS Foundation  was born, a remarkable organization dedicated to helping RLS sufferers, their friends, and families. The foundation isn’t remarkable because of its relevance, influence, or efficacy, but rather for its funding streams. From a 2006 New Scientist report on patients groups:

The Restless Legs Syndrome (RLS) Foundation…received more than $450,000 of its $1.4 million revenue in 2005 from GlaxoSmithKline (GSK) and nearly $178,000 from Boehringer Ingelheim…While these symptoms can seriously disturb sleep, critics claim that their prevalence has been exaggerated by GSK and in media reports...The extent of industry funding of the RLS Foundation is "pretty incredible", says one such critic.

For those of you counting, a whopping 44.8 percent of the RLS Foundation’s revenue comes from the companies that manufacture RLS drugs. This unsettling fact becomes downright alarming when one considers that the RLS Foundation has a research grants program. Funded projects include “Identification of restless legs syndrome in children” and a slew of research dedicated to finding the “RLS gene.”  Over time, the foundation has been aggressive in increasing grants for research and there’s no reason to believe this trend won’t continue.

And of course, media saturation will continue as well. In July of this year, ABC News had a story about Requip (GlaxoSmithKline’s RLS drug), framing it as the final word in “curing” RLS. That same month the Mirapex marketing campaign started in earnest. 

A questionable disease, a questionable treatment, and a clear conflict of interest—all hallmarks of disease mongering at its finest. 

Comments

[harry]

Nov.2008.Neverheard about RLS, or the drugs,but sure have very "twitchy"legs at night.I asked many doctors about it, and naturopaths,they did not know what i "meant".Luckily I found 30 years ago, that if I put my legs in cold water, i COULD sleep.Colder days also helping,hot days ofcourse don't. Believe me it is a PEST of a discomfort.Questionable??
get a life! It gives me VIOLENT twitches.30 years later i am still searching for answers,(and I am VERY health conscious).When I eat food with MSG without me knowing beforehand, my hands can also twich and itch.Questionable? Shame on you, you heartless so and so.Is the earth still flat?

[harry]

Nov.2008.Neverheard aboutRLS, or the drugs,but sure havevery "twitchy"legs at night.I asked many doctors about it, and naturopaths,they did not know what i "meant".Luckily I found30 years ago, that if I pit my legs in cold water, i COULD sleep.Colder days also help,hot days ofcourse don't. Believe me it is a PEST of a discomfort.Questionable??
get a life! It gives me VIOLENT twitches.30 years later i am still searching for answers,(and I am VERY health conscious).When I eat food with MSG without me knowingbeforehand, my hands can also twich and itch.Questionable? Shame on you, you heartless so and so.Is the earth still flat?

[Rita]

I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this new drug! The unthinking public is going to pressure their doctors into giving them something just because it’s new, when something old or generic would do the job for cheaper.

[Dan]

Published on www.brainblogger.com

Your Television as you doctor?

Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state and the commercial is sponsored usually by a big pharmaceutical company for a particular network. This is called direct to consumer advertising, and doctors would prefer they did not exist.
Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns. And involves money spent that could be applied to greater uses, according t many, but we are dealing with a corporation here.
The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective, which is to increase sales and grow their market and, in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition. Furthermore, the FDA has admitted that they are ignorant as far as the content of such DTC ads, in relation to their accuracy and clarity, as well as their effect on the health care system.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe to be medical flaws, and illustrated by the creators through exaggeration and embellishments through media sources as an avenue for suc propaganda, as is often seen with DTC advertising. Yet the flaws may not be medical, but corporate creations of these questionable human ailments that do not require treatment, possibly, and may be an attempt to develop a particular medical condition to acquire profit. One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.
Also, DTC ads discuss only one treatment option normally, so it seems, when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the doctor, as they assess your health, not your television or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of our country and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome for the doctor chosen for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some over-prescribing, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which is far from financial prosperity.

“Do every act of your life as if it were your last.” ---- Marcus Aurelius

Dan Abshear

[Jdach]

The truth is that RLS is disease mongering by the drug companies pure and simple. This is a manufactured disease which represents symptoms of magnesium deficiency which is quite common. Every single patient with so-called restless leg syndrome that I have seen has recovered promptly with inexpensive magnesium supplentation. Requip is a powerful Parkinson's drug with side effects such as compulsive gambling. This kind of misbehavior by the drug industry is a red flag indication of a broken medical system, and the dysfunctional government that allowed this to happen.

To read more:
http://jeffreydach.com/2008/04/02/restless-leg-syndrome-requip-and-disease-mongering-by-jeffrey-dach-md.aspx

Jeffrey Dach MD
http://www.drdach.com

[Sleep Disorders Guide Blog]

Healthy post... Niko,

Restless leg syndrome is a common condition to hear from people with fibromyalgia.

Restless leg syndrome and fibromyalgia are currently under study for ways to treat and prevent them.

Both disorders disrupt sleep in one way or the other and this lack of sleep can have undesirable side effects including poor job performance, lack of safety while driving and problem in enjoying social activities.

[Niko Karvounis]

Herb,

You're exactly right, RLS is nothing to dismiss as non-existent. Check out some of my earlier comments on this post to see my clarification on this point.

Best,
Niko

[Herb]

As someone who has suffered with RLS for many years, who tried all the other options before resorting to mirapex, and for whom a very low dose of mirapex has been very effective in providing relief, I am bothered by your generalized statement that RLS is a questionable disease and that mirapex is a questionable treatment. ANY disease can be misdiagnosed and ANY treatment can be misapplied, but does that mean that the disease itself is "questionable"? My doctor recommended mirapex to me after hearing my symptoms, and long before it was advertised on TV. I agree with your criticism of drug advertising, but I object to your innuendo that RLS sufferers are mostly hypochondriacs who do not deserve the attention of the medical profession.

[Niko Karvounis]

Wendi,

I second Dr Matt's thoughts here. No one is saying that only fatal diseases should be addressed, or even that the drug companies don't have the right to fund a foundation.

But, as I've said in an earlier comment, we have to think of proportionality and profit: is the "awareness campaign" commensurate to the actual scope of the problem, and is a foundation purportedly functioning in "the public interest" trustworthy if almost half of its funding comes from those who look to profit off RLS?

These, I think, are valid concerns not really tied to how much RLS is a "real problem."

Thanks for your comment!

[drmatt]

Wendi,
I am definetly not denying it is a problem. I have had many sleepless nights, on call watching people die in front of me because they couldnt afford what was available to help them in the first place. Talking to thier families about what happened and why. It is not the medication or research for the disease (RLS) that I protest. It is the amount of money and advertising that generally seems extravagant and obscene when you work on the front lines of medicine.

[bluegreyglass]

I get this sometimes at night or sitting in class, but it usually means I just had too much coffee.

[Wendi]

I think this is why we are allowed to live in America -- so we can donate to the organization that we would like? The RLS Foundation supports people who live with this condition through education and awareness (which, before these drugs emerged, didn't exist.) If you have ever not slept for a night or not slept for 2,3,4,5 nights, you would realize that this is a major problem. Just because people don't die from it, doesn't make it not a problem.

[Tim]

drmatt -- no problem. As I replied to Niko, I share many of the same misgivings about how health care is "marketed."

Having said that, even if there are certainly more pressing priorities on a grand scale, I don't think we should ignore less "urgent" problems which, while not life-threatening in any way, are still significant quality-of-life issues.

Unfortunately Big Pharma's marketing machine is good at convincing many people that their "quality of life" is more impaired than it really is, and it can all be magically cured by their wonder drug at $200 per month...

[drmatt]

Tim,
Sorry for any misunderstanding, and in actuality I do have it. It is more about the amount spent on a disorder/disease that has little over all clinical impact (not that it doesn't effect quality of life, believe me I know). The overall point is this, if we have a treatment for something that is not going to lead to loss of life or limb, and the treatment is pretty good (all things being relative) than money spent on foundations, advertising and further research seems, well, wasteful. I for one would much rather see the money go to cancer research, or basic health care for those who are not getting it? Does it seem odd that we can afford to invest in this when we haven't even immunized all of our children against "deadly" diseases?

[Tim]

Niko -- you wrote, "If Mirapex, or drugs like it, help people who really need it, then it does some good, and I don't want to bad-mouth those instances. But having a drug is not the same as working hard to convince millions that they need it. "

Well, that's fair and I completely agree with you here. That's why I wanted to emphasize that she endured the condition -- almost every night, rendering her unable to sleep -- even before we ever heard of RLS or any medications for it. There were no commercials or ad blitzes which tricked her mind into thinking she had a condition she really didn't physically have, and I think that's significant here.

I frankly don't like ads for expensive pharmaceuticals because I don't think it's good to plant "seeds" in the minds of people that they may have something, or that their minds may start playing tricks on them (in which case the condition would be "in their head").

I have no doubt that some people who only occasionally deal with this -- or never had if before seeing those commercials -- will start "imagining" the condition; the mind can really screw with our bodies sometimes.

Of course, we have that pesky First Amendment which prevents the FCC or the FTC or the FDA from squelching their right to advertise. So in that sense, I'm not sure what can be done other than encourage medical providers to (a) push lifestyle changes before pushing expensive designer drugs and/or (b) try something available in generics before pushing the expensive stuff. Again, the problem here is that Big Pharma schmoozes doctors into prescribing their drugs, which I think is a massive conflict of interest in that one can't know whether the doctor's primary motivation is the patient's physical (and financial) well-being or the next earnings report from Big Pharma.

[Niko Karvounis]

Tim,

You caught me on having a last line focused on "oomph" more than nuance here (and I meant no disrespect), but I hope that I did make clear elsewhere in the post that I think RLS is a real problem (see "To be fair, no doubt there are people out there who suffer from RLS in some form. But do they all need to be medicated?").

Ultimately, the issue is proportionality on the aggregate scale--not that no one suffers from RLS or that Mirapex doesn't work for some people.

Most disease mongering isn't about concocting something completely new, but rather harping on something that is either rare or generally moderate, thus turning it from a problem into an epidemic.

If Mirapex, or drugs like it, help people who really need it, then it does some good, and I don't want to bad-mouth those instances. But having a drug is not the same as working hard to convince millions that they need it.

[Tim]

drmatt -- You write, "No offense to Tim and his wife, I wish all people could be comfortable all the time, but as being human would have it, that is not possible. "

Can I take that to mean that if you or someone you loved had this condition and it prevented being able to sleep and caused significant discomfort, AND if lifestyle changes weren't enough to ameliorate the condition, you'd advocate just sucking it up and bearing it because of the cost of treating it in other ways?

Or that I should tell my wife to suck it up and deal with it because it will cost "the system" too much to relieve the symptoms?

That's how it sounds to me.

[drmatt]

This is not an uncommon occurance and it is a system that pushes our extravagance and health system budget to the brink. No offense to Tim and his wife, I wish all people could be comfortable all the time, but as being human would have it, that is not possible. Prioritization of how we spend our health care dollar demands that we start with investing in life and limb concerns. When I was studying for the USMLE II (United States Medical Liscensing Exam) one of my professors told me, don't study malaria, despite the fact that it kills millions of people every year it won't be on the test because it doesnt effect rich people, but lyme disease (from lyme connecticut, incidence 1500 cases a year) study that. In fact there were three questions on lyme disease, none on malaria. As long as we have a money driven system the priorities will be profit.

[Tim]

"A questionable disease"

Tell that to my wife. She experienced the symptoms almost every night before we even *heard* of RLS or any drugs to treat it.