A biopharma is hoping to add to the deluge of drugs by the end of this year, but in virgin territory for the pharma industry. A new orphan indication? A disease that has previously been ignored? Nope - for that horrific debilitating disease that strikes fear in the heart of every traveler - jet lag.

What? Yes, jet lag. This is classic disease mongering. Disease mongering is "a pejorative erm for the practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments." Wiki sums up the two sides nicely:

Proponents of this practice argue that the pharmaceutical industry is only providing the public with information about its options and that actual prescription is a matter to be discussed between patient and doctor. Opponents, however, claim that this approach leads to the unnecessary prescription of drugs, that its motivation is only to profit the drug companies, and that it may actually harm instead of help patients.

To read more about disease mongering, check out this collection in PLoS Medicine, read Ray Moynihan's Selling Sickness, or read more about it in Gary Schwitzer's blog. Schwitzer's Health News Review includes disease mongering as one of the criterion for rating health news stories, in which the story exaggerates or over-sells a condition.

There are different forms of 'mongering' – turning risk factors into diseases (e.g., low bone mineral density becomes osteoporosis); misrepresentation of the natural history and/or severity of a disease (e.g., early-stage low-grade prostate cancer); medicalization of minor or transient variations in function (e.g. temporary erectile dysfunction or female ‘sexual dysfunction’); medicalization of normal states (baldness, wrinkles, shyness, menopause); or exaggeration of the prevalence of a disorder (e.g., using rating scales to ‘diagnose’ erectile dysfunction). A news story may contain more than one example of mongering.

Identifying disease mongering is a matter of judgment. Sometimes it is obvious. But
how do you decide if an article on irritable bowel disorder, erectile dysfunction, restless leg syndrome or osteoporosis (all of which can be serious for some sufferers) is misrepresenting the condition to the public?

An Unsatisfactory story may present spurious statistics; exaggerate the human consequences; create undue fear; treat surrogate markers endpoints as if they were disease; include interviews with “worst-case” patients - holding such patients up as examples as if their experiences were representative of all with this condition.

So what's going on with jet lag? (Which, by the way, is definitely an inconvenience, but not a disease.) The company Cephalon, which launched its drug Nuvigil in June 2009 (to improve wakefulness in adults who experience excessive sleepiness (ES) associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder, or narcolepsy), submitted a supplemental drug application (basically an add-on to the original application) to FDA, asking the agency to approve Nuvigil as "a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to
eastbound travel."

The supplemental application is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe (read more about the data here).

Interestingly, the current label for Nuvigil includes a bolded warning for serious or life-threatening rash (including Stevens-Johnson syndrome, which is a life-threatening skin condition).

So, for a "disorder" that resolves on its own and can be treated by non-pharmaceutical methods, I'm supposed to pay for a prescription drug that carries a serious warning? If this were treating terminal cancer, that's one thing. But jet lag? All this mongering tires me out. Maybe I need Nuvigil.