A clue to disease mongering can be found in how the condition is classified and described.  It will often be announced as a ‘syndrome’ rather than calling it a disease. Syndrome is a medical term for a collection of symptoms that occur together and roughly define a condition. This is different from the strict definition of disease, which requires definite pathological markers that clearly delineate normal from abnormal. ‘Syndrome’ is readily translated into ‘disease’ in the minds of the non-medical public.

The latest example of disease mongering is Restless Legs Syndrome (RLS). It is a true ‘syndrome’ in that all of the criteria for making a diagnosis are subjective, meaning they are all just symptoms. There are no objective measurements to determine if someone has this, nor is there any actual tissue pathology necessary to the diagnosis. RLS is defined as an urge to move due to an unpleasant feeling in the legs, with onset or worsening of symptoms when at rest or not moving around frequently, obtaining partial or complete relief by movement. Symptoms occur primarily at night and can interfere with sleep or rest. If such a feeling strikes your legs even less frequently than once a month, you still fall into the criteria for an RLS diagnosis.

Once the diagnostic criteria were established, however vague, it was necessary to popularize the condition. Take a look at the Restless Legs Syndrome Foundation. It is a classic in pretended grassroots organizations, which have become known as ‘AstroTurf©’. The two manufacturers of drugs for RLS, GlaxoSmithKline (GSK) and Boehringer Ingelheim are listed as Gold Level Sponsors of the RLS Foundation. The first ever press release of the Foundation was coincident with the FDA’s approval of GSK’s new RLS drug. In fact the website displays the same blue and gold colors as the packaging for Glaxo’s drug.  GSK’s Senior Vice President of Worldwide Development, Ronald Krall, MD, was awarded with the RLS Foundation’s first ever Science Award. Dr. Krall himself selected the researchers that came up with the statistics describing how many supposedly suffer from the syndrome. Several of the members serving on the Foundation’s Medical Advisory Board are or have been in the pay of Glaxo, Boehringer and other drug makers.

The next step in disease mongering is to flood media outlets in order to worry people into considering that they might be stricken with the new syndrome. The target of these campaigns are the ‘worried well’, those in search of diagnoses to quell their fears of everyday living. A key to an effective campaign is to stress the emotional and social consequences of the dreaded condition. People with these symptoms are characterized as victims and are routinely called ‘sufferers’.

RLS Awareness Week was invented. Supports groups were set up to offer helpful resources. Symptom checklists were made broadly available so that the masses could self-diagnose. Direct to consumer advertising implied that your doctor has missed your symptoms and failed to properly diagnose you. ‘Ask your doctor’ ads do not mention the drug specifically, and therefore are not required to offer full disclosure. They are allowed to convey misleading suggestions.

After the first media blitz a carefully selected poll company-sponsored poll was conducted to ask about these symptoms, and the results were used to prove its previously unrecognized prevalence. Before the advertising, the closest a patient ever came to having the criteria for RLS were those who had drug-induced movement disorders, usually caused by the Parkinson’s disease medications or side effects of the drugs used to treat mental patients. More common were the complaints of muscle twitching and cramps in young athletes with dehydration and in sedentary middle-aged men with mineral deficiencies. After the aggressive self-diagnosis campaign, the RLS Foundation reported that suddenly 1 in 10 Americans had the affliction. Glaxo paid for the study, done by one of the Foundation board members.  ⁱ The prevalence figures were broadly distributed in a news release direct from company headquarters.

The RLS scourge got a big boost when the New England Journal of Medicine came out with an article suggesting a genetic link. The claim of a definite genetic cause for any disease seems to really clinch the strong scientific footing in the minds of the lay public. That’s real science, or so it seems. This reflects a misunderstanding of the convoluted statistical difficulties that complicate the entire field of genetic tracking. A suggestion of a genetic link is related to a definite genetic basis for disease in the same way that a foul smell in a gym locker proves that the cafeteria served up Rueben sandwiches that day.

What was studied was not a gene marker for RLS, but rather for leg movements seen in families with members who have a diagnosis of RLS.  Much to the delight of the drug makers, the news media erroneously picked up the story as a report on ‘the RLS gene’. The Journal’s required disclosure statement revealed that many of the genetic study authors were in the pay of drug manufacturers. The companies had a financial interest in the results of this study, including diagnostic products and patents.ⁱⁱ

An important flanking action to the ads were the correlating pseudo-news stories. This stealth advertising is fake news, providing corporate plugs in the guise of independent reporting. So called video news releases, or VNRs, they are carefully scripted infomercials produced by the drug maker or distributor, that are shot like a news story. The station can run the VNR as received or the newsroom editor is free to use it as he sees fit.  It is common to create a feature around the VNS, using its text word for word or using only portions of it. This gives the impression that the reporter investigated it himself. While VNRs are subject to some FDA regulation, those rules do not apply when a station simply excerpts some pieces of the VNS around its own reporters ‘story’. According to the Federal Communications Commission's April 2005 Public Notice, TV stations airing VNRs "must clearly disclose to members of their audiences the nature, source and sponsorship of the material."  This applies whether or not the spot was bought and paid for or just run for free.  ⁱⁱⁱ However enforcement is only driven by consumer complaints. Just how can you lodge a complaint when you don’t know the source of the very well disguised newscast material?

These ads not only aggressively encourage more diagnosis; most important of all, they suggest strongly that every case needs treatment. Supposedly a restless leg night results in sleepiness and fatigue the next day, thus ruining your quality of life. Treatment is glorified in the ads with testimonies of miraculous life-changing effects. The ads fail to mention that the main reasons to treat, sleepiness and fatigue, are also the very side effects of the drug used to treat RLS. The drug maker’s patient information website explains that the most common adverse events with Mirapex (Boehringer Ingleheim) are nausea, headache and tiredness, occurring at twice the rate as in people who took a dummy pill. It was only tested for safety for one year and in only 75 patients. The package insert carries prominent warnings about suddenly falling asleep at the wheel and problems with blood pressure regulation. The drug’s most notorious effect is the potential to cause compulsive behavior including pathological gambling, hypersexuality and compulsive eating.