13 APRIL 2006
In their quest for profits, drug makers have stooped to manipulating the public by, in essence, inventing diseases. So goes the theme of the April issue of the journal PLoS Medicine. The free, online science journal focuses on a tactic that critics call "disease mongering." According to Ray Moynihan and David Henry, guest editors of the special issue, disease mongering is a way to broaden the market for a drug with a "selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments."
Moynihan and Henry charge that this practice "turns people into patients, wastes precious resources, and causes iatrogenic [doctor-caused] harm." And they add that many of the "patient advocacy" groups for various disorders actually get a large portion of their income from pharmaceutical manufacturers.
If you have seen the nightly network news recently, you've seen mongering at work. Erectile dysfunction, the trademark Viagra condition, now has a female counterpart. "Premenstrual dysphoric disorder," fortunately enough, can be treated with an Eli Lilly product -- Prozac under a new brand name.
Legs feeling restless?
Maybe you've seen the ads on "restless leg syndrome" -- those beautiful (if unmistakably middle-aged) legs, jumping around. The PLoS article on restless leg was written by Steven Woloshin and Lisa Schwartz of Dartmouth Medical School.
Restless leg syndrome is marked by the urge to move the legs, especially at night. Severe cases can even interfere with sleep. In mild cases, exercise, stretching and (the horror! The horror!) cutting back on caffeine, can all help -- if any relief is needed at all. Nevertheless, in 2003 GlaxoSmithKline, maker of ropinirole, a drug for treating Parkinson's disease, began marketing ropinirole for the syndrome with a press release entitled "New survey reveals common yet under recognized disorder -- restless legs syndrome -- is keeping Americans awake at night."
Ropinirole is a "dopamine agonist," meaning that it increases the effectiveness of dopamine, a neurotransmitter that triggers muscular contraction. The death of cells that make dopamine causes Parkinson's, a deadly movement disorder.
The old and the restless
So how did the media cover restless leg syndrome after Glaxo's marketing blitz? Woloshin and Schwartz identified 33 newspaper articles on the syndrome, and found that 97 percent "uncritically accepted" the definition of the disease. None warned of the dangers of over-diagnosis, the authors added, "the idea that some people will be diagnosed unnecessarily and take medication they do not really need."
Over-diagnosis can matter, Woloshin and Schwartz wrote us. "A famous study of healthy workers screened for hypertension found that workers given the diagnosis of hypertension (both those given and not given drug treatment) subsquently had higher absenteeism from work and lower perceived quality of life. So simply giving people a diagnosis tends to make them feel and act sick. And of course, treating people with minimal symptoms still exposes them to substantial side effects."
And then there is the question of how many people have the condition. Much of the media coverage mentioned that 10 million American adults have restless leg, which makes for a huge market. And indeed, Woloshin and Schwartz said that sales of Requip, Glaxo's brand of ropinirole, have quadrupled since it was approved for restless leg.
Graph from PLoS Medicine
Claims about the drug itself also got an easy ride, in the opinion of Woloshin and Schwartz, who do research on the use and effectiveness of medicines. Only 7 percent of the reports quantified the benefits of ropinirole against restless leg. More numbers could make for interesting reading, however. According to the prescribing information on file with the Food and Drug Administration, 73.3 percent of ropinirole patients responded to the drug after 12 weeks of treatment. So did 56.5 percent of those who gobbled placebo pills. The difference was significant, in Glaxo's opinion, but it is still a small improvement.
A second failing, Woloshin and Schwartz wrote, was that "only one news story noted that the ropinirole trials were 'relatively short' in duration (the longest was 36 weeks), despite the fact that many people would use the drug for years or even a lifetime." Over long periods, rare side effects can cause significant problems, especially if large numbers of patients take the medication.
Another article in the same issue of PLoS Medicine described how Pfizer converted Viagra, a drug originally sold to improve sexual function in men with spinal-cord damage and other severe medical problems, into a highly profitable "lifestyle drug." A third focused on the alleged role that teachers have played in "medicalizing" attention deficit hyperactivity disorder.
Graph from PLoS Medicine
Mongering, or just being helpful?
To the PLoS authors, publicizing diseases and selling treatments can be a nefarious practice that moves drugs, often at patients' expense, and creates "diseases" from conditions that are part of normal life. But to the medicine industry, these ads are just being helpful. In an April 10 press release, the Pharmaceutical Research and Manufacturers of America said, "Disease afflicts millions of patients' lives every day worldwide. This is why it is important that physicians, academics, research-based pharmaceutical companies and even journalists should play an active role in helping raise awareness about a wide-range of diseases such as osteoporosis, cancer, obesity and arthritis."
Glaxo is apparently not daunted by the coverage of restless leg. On April 7, it trumpeted a new approval for ropinirole in treating restless leg in Europe.
One final note, if your legs have a tendency to move by themselves at night. If you are considering ropinirole, you better not mind the urge to purge. In Glaxo's study, 38 percent of ropinirole patients experienced nausea, compared to only 8 percent of those who got the inert pill.
— David Tenenbaum
• Woloshin S, Schwartz LM (2006) Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick, PLoS Med 3(4): e170.
• Woloshin and Schwartz
• BBC reports on drug firms inventing diseases