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Is it fair to call jet lag a ‘disorder’ requiring a pill if it goes away on its own?

HETLIOZ® (tasimelteon) Demonstrates Efficacy to Treat Jet Lag Disorder in an 8 Hour Phase Advance Clinical Study

Our Review Summary

This drug company news release describes positive results of a clinical trial of tasimelteon, a melatonin receptor agonist, to treat jet lag in long-distance — especially eastward going — flyers across multiple time zones. The trial of 318 healthy volunteers in a sleep lab, the release states, showed “significant and clinically meaningful” benefits, namely an average 85 minutes more sleep, less wakefulness during sleep and some very modest average increases in alertness on two laboratory tests. The release noted reported side effects, particularly in older people, such as headache, nightmares, and urinary tract or upper respiratory infections. But no where in the release do readers learn a) how exactly the study mimicked 8-hour time zone crossings; b) the makeup of the study group with respect to age, gender, race, etc.; c) the fact that most jet lag goes away in a day or two without treatment; d) alternatives to the new drug such as “sleep education,” melatonin itself, or light therapy; and e) costs of the new drug and comparative therapies.

Readers do learn that the drug has been approved for a rare and chronic circadian rhythm disorder in totally blind individuals in whom certain sunlight-brain mechanisms are absent. But overall, this release smacks of being yet another “solution” in search of a “problem” serious enough to warrant what could be expensive pills in search of a very large (and mostly unnecessary) market.

 

Why This Matters

Jet lag is real and unquestionably unpleasant. For shuttle diplomats and the multitudes who regularly “commute” between, say,  Washington,D.C., and Singapore stuffed into economy class seats, it’s likely that no amount of pre-trip sleep shifting, hydration, or physical fitness will eliminate the thick-headed grogginess and wee-hours hotel-room insomnia that bedevils them. Sleeping pills have their downsides, but in appropriate doses for those who can safely take them once in a while, they can help. Melatonin helps others, but inconsistently. For most of the jet-lagged, though, it’s the tincture of time that is the great healer, and most travelers successfully manage business, sightseeing and rest within a day or two of landing. The good news is that for healthy travelers, jet lag is not a serious illness or disorder. But  for many if not most people already hassled by the long waits and vagaries of airline travel,  the promise of eliminating jet lag is alluring, so the news of the clinical trial of tasimelteon (marketed as Hetlioz by Vanda Pharmaceuticals), could clearly open up an eager market. News releases and stories based on them should therefore squarely deal with the challenge of whether the benefits — real but modest — will be worth the costs and side effects risks.

In 2016 STAT reported that Vanda spent $29 million on a TV campaign aimed at use of the drug for people with non-24 disorder, a condition that affects the sleep-awake cycle. Why they did this for a drug that has no market competitors is unclear. This release seeks to introduce the drug to a different and more lucrative market. 

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Hetlioz currently costs an estimated $280 per capsule or $102,000 a year for the blind and a relatively few non-blind who use it to treat a rare circadian rhythm disturbance. Cost is a significant data point in any story promoting a drug’s benefits, especially if the benefits are relatively modest.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release offered a dense table of results of the clinical trial, although without more information about the trial design, especially the make up of participants and comparison groups if any, it’s hard to know exactly how significant the clinical findings are, particularly for those who are leisure travelers who don’t have to negotiate world peace the moment they land at the end of a 16-hour flight. The primary outcomes from the sleep study are not clearly described and the clinical significance of those results are unclear. Therefore, it is difficult to draw conclusions about the benefit of the drug.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The end notes attached to the release describe potential harms in clear terms.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

For readers to better understand the potential value of the jet lag drug, the release needed additional information about the participants, the design of the study, how long side effects lasted, how many — preferably in absolute numbers — sustained ill effects, and how the benefits compare to other drug and non-drug therapies.  Since the conditions of the experiment are not clearly laid out (how the 5-hour jet lag was induced), the outcomes, although statistically significant may not be clinically important.  The issues of the study that we noted in the summary paragraph suggest that we really can’t draw any other conclusions about the effectiveness of the drug.

Does the news release commit disease-mongering?

Not Satisfactory

There was some mongering here. Although jet lag is clearly common among long distance flyers, the idea that it is a “circadian disorder” in need of extravagant drug treatment is troubling. Late shift workers, and some military personnel, along with some percentage of business travelers clearly have a chronic problem that could qualify as medically in need of serious therapy. But it’s likely a substantial percentage of them already cope with the symptoms. First class and business class flyers able to sleep better across time zones, for example, are likely over-represented among frequent business travelers.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

Information and references for further information about financial support are contained at the end of the release and it’s clear that Vanda sponsored the trial.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

There are lots of ways to deal with this problem beyond taking an expensive pill, none of which are mentioned.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release makes clear that the drug has not been approved anywhere in the world for treatment of jet lag. However, there is a statement at the end of the news release that the company has been granted “market authorization” by the U.S. Food and Drug Administration and the European Medicines Agency. Does this mean that they have approval to start selling the drug? The Hetlioz website only lists “Non-24-Hour Sleep-Wake Disorder” as an indication for the use of the drug.  This is very confusing for readers.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release says essentially nothing about how the drug works, or how it is better than, or different from, other jet lag therapies and preventive measures such as melatonin and light therapy. The drug is a melatonin receptor agonist, meaning it’s designed to work in the brain in ways similar to melatonin, but the release doesn’t discuss any of this.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t engage in blatantly unjustifiable language.

Total Score: 4 of 10 Satisfactory

Comments (1)

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Andrew DePristo

March 13, 2018 at 6:46 am

While the news release is blatant advertising, this column also misses the point that not all maladies have to be life threatening in order to justify treatment. Think about colds, sore muscles, general pain, irritable bowel syndrome, etc. While cost is important, perhaps the much larger market will make the pills cost only $28 each. If so, the extra 1.5 hours of sleep could reduce the recovery from jet lag from 2 to 1 day. For an American vacationer, paying $28 (or even $100) to get an extra day of activity on an expensive European vacation would be well worth the money. Your criticism mixes the advertising nature of the company’s “news release” with the benefits of a drug. I would suggest that you continue to criticize the former but leave the benefits issue to the patient and his/her physician.

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