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Actelion Sleep Aid Does Well In Midstage Clinical Trial

Rating

4 Star

Actelion Sleep Aid Does Well In Midstage Clinical Trial

Our Review Summary

This is a short story about a possible new drug treatment for insomnia.  The most helpful information in the story is that the drug has a novel mechanism, and is currently being tested.  While of interest, the story failed to provide sufficient information for readers because it is lacking in independent expert opinions about the value (to patients) of the new drug, discussion of potential harms, as well as failure to mention behavioral treatment for insomnia.  The details about the benefit from the use of this drug come from a single small study of selected individuals and the information is derived from company sources. (See our primer on some of the pitfalls of reporting news from scientific meetings.) Having some individuals knowledgable about the problem of insomnia comment about the some of the strengths and weakness of this potential medication would have greatly improved this story.

  

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

Costs were not discussed but this drug is still in development.

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

Satisfactory

The story reported the benefit (increased time spent sleeping compared with a placebo) as ‘significant’, though the only statistically significant result contained in the company presentation about this product was something termed "increased sleep efficiency".  Although the data on total sleep time was greater for those taking the 200 and 400 milligram dose of this drug than placebo, it is not clear from the way the information was presented that it represented a statistically significant increase.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story mentioned that ‘few side effects were reported’.  While it is true that ‘few’ is a subjective term, it would have been useful for readers to know that ~13% of those taking the 200 milligram dose experienced side effects; further – in order to have some idea about how to value the side effects, it would have been helpful to list that the side effects included fatigue, dry mouth, headache, and drowsiness.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story reports on a randomized clincial trial, states that it was performed by the drug company, gives the number treated and the main result.  It is worth noting that the data on the main result differs from the information available at the company website. 

The results presented in the story: "people taking a 200 milligram dose of almorexant slept 59 minutes longer than those on placebo";  the increased sleep efficiency reported on the website for those taking the 200 milligram dose was 31.4 minutes.

Does the story commit disease-mongering?

Satisfactory

The story did not engage in overt disease mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story did not appear to make use of any independent sources of information regarding the clinical efficacy of this drug.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

While the story mentioned one other category of drug used in the treatment of insomnia, it did not mention that a range of treatment options exist including lifestyle changes that may be of benefit.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

While the story did not explicitly state that this drug is not yet available, the first sentence makes it quite clear this drug is still in development and in the process of undergoing clincial trials.

Does the story establish the true novelty of the approach?

Satisfactory

This story appropriately reported that the drug described was a new drug with a novel mechanism.

Does the story appear to rely solely or largely on a news release?

Not Applicable

The story is about what appears to be a corporate-sponsored presentation at the World Sleep Congress.  While this is not technically a news release, readers should know that it is somewhat comparable.  Until more work is done and peer-reviewed, they may not be getting the entire picture.  See our primer on some of the pitfalls of reporting news from scientific meetings.

Total Score: 5 of 8 Satisfactory

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