This is an incomplete story about an early stage study of a drug in Phase 2-3 development. The headline and the opening paragraph suggest that the drug does in fact work for jet lag. It is far too early to jump to that conclusion. The study design and sample size are noted as well as a word of caution from an expert not involved in the research. The failure of the report to note the availability of Rozerem, a close cousin to the test drug is significant as it relates to the novelty of the finding. The recently completed but unpublished study with Rozerem for real jet lag is an example of why the context for this type of report is of significance.
The sponsor of the study, Vanda Pharmaceuticals, recently suspended all commercial and developmental work as a result of "not approvable letter" from the FDA for its antipsychotic drug iloperidone. This suspension of all activities is also important contextually given the apparent instability of the company. It’s odd that this story never commented on this issue. See: http://www.bizjournals.com/washington/stories/2008/10/27/daily85.html
If it’s not too soon to talk about experimental results that brought "relief to jet-lagged travelers and night-shift workers,’ then it’s not too soon to expect some discussion of costs. Even projections. The story might have also reported on the cost associated with existing drugs noted in the article as a reference point for readers for calculating the value of the improvements in sleep effciency.
Although the story reported that the drug was found to restore near normal sleep and that the individuals who took the drug performed normally the next day, it failed to include quantitative information about these two benefits. Did everyone experience ‘near normal’ sleep? And how close to a regular sleep pattern is ‘near normal’?
In addition, the headline of the story is misleading when it says the drug in question may "put jeg lag to rest." The study is an early phase investigation and was conducted in a relatively small number of subjects. Suggesting the drug may work is a bit premature based on the evidence to date.
The story mentioned that there weren’t significant harms associated with the treatment but failed to list what the harms were or how many individuals were affected. A quick review of the literature on a close cousin (ramelteon, Rozerem) would have provided a more complete picture of the possible side effects from drugs that work in this way. Headache, daytime sleepiness, dizziness, tiredness, nausea and worsening insomnia are listed as common side effects with Rozerem. In addition, the story should have mentioned that this was a single use of the drug in a clinical setting and that there is no information about potential side effects from more frequent use of this medication.
While the story did an acceptable job reporting about the evidence about this drug, the headline provided an inaccurate picture of what is and is not known about this medication. The story mentioned that it was reporting on results of a recent study published in the journal Lancet. It then provided some information about the smaller (phase II) study but did not provide information about the larger (400 person, phase III) clinical trial.
The story did indicate that the study and the researchers involved in the study received funding from the company that manufactures the drug.
It is important to note that the people studied did not suffer from either jet lag or night shift work but instead were people in whom an artifically created sleep time chance was created. As such and as pointed out by an unaffiliated expert in the story, there is still not evidence that this drug will provide benefit in the target population.
The story did not engage in overt disease mongering.
The story included quotes from one person involved in the study reported on as well as one individual who was not involved in the study. In addition – an annoymous group of ‘experts’ provided some information about limitations about the recent study.
The story mentioned the use of melatonin as a substance that has some potential to improve sleep related issues and prescription sleep-aids. But it did not contain any information about sleep hygeine which also might be leveraged by individuals with sleep-related problems. It also failed to describe other sedative hypnotics, such as Rozerem, a drug with the same mechanism of action.
The first mention of the drug reported on included the adjective ‘experimental’, accurately reflecting treatment availability.
The study indicated that the drug reported on was considered experimental but that it mimicked the effects of the hormone melatonin which itself is an available product. The story failed to note the availability of the drug ramelteon (Rozerem) which has a similar mechanism of action. The lack of comment on the close relationship between a commercially available drug (Rozerem) and the drug under study is a significant lapse.
This story does not appear to rely on a press release.