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Vanda sleep drug effective in second late-stage trial


2 Star


Vanda sleep drug effective in second late-stage trial

Our Review Summary

While this apparently was written as a business story, it’s not clearly labeled that way when we found it online – and that’s the way most consumers would find it.  In fact, the Chicago Tribune picked up the Reuters wire story and ran it on its HEALTH page.  In that context, the story simply doesn’t provide readers the kind of information they need to be able to judge whether this drug was “effective” in the latest trial or not.

This is the kind of health care news story that simply contributes to the cacophony in the daily drumbeat of health news.

It doesn’t help anyone so much as the drug company.


Why This Matters

Non-24-hour disorder is undoubtedly a rare and serious condition.  People who want to learn about it and about treatment options for it deserve better than what they got from this story.  It includes no useful information for readers about why the new drug may be important enough for the news, and no helpful information about the sleeping disorder it is aimed to treat.


Does the story adequately discuss the costs of the intervention?

Not Applicable

Not applicable.  No cost estimate given but this is still an experimental approach.

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

Not Satisfactory

The description of benefits was vague, with no quantification.

For example, the story reported: “The second trial showed that patients treated by the drug maintained their clinical benefits while placebo-treated patients showed significant deterioration in measures of night-time sleep, daytime naps and timing of sleep.”

Maintained what clinical benefits? What was the actual comparison with the placebo group?

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

Not Satisfactory

No discussion of potential harms. Even a brief discussion with a specialist or generalist who prescribes the similar drug ramelteon would have yielded some information about possible harms.

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

Not Satisfactory

No discussion of the limitations of drawing any conclusions from a study of 20 people.  Granted, this is a rare condition.  Nonetheless, some independent analysis of the quality or limitations of the evidence was required.

Does the story commit disease-mongering?


No disease-mongering of the condition known as non-24-hour disorder.

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

Not Satisfactory

The only source appears to be the drug company CEO.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story may have used company-supplied language when it reported that the condition “has no approved treatment.”

There is no approved prescription drug treatment.

But there are non-prescription-drug options that the story never mentioned:  light therapy, hypnosis, stimulants, melatonin, to name a few.

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


The story referred to the drug tasimelteon as an “experimental drug.”  And it reported that the drug company plans to apply for FDA approval in mid-2013.

Does the story establish the true novelty of the approach?

Not Satisfactory

The relative novelty of this experimental approach was never explained.

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

Not Satisfactory

This quote comes straight out of a company news release:

“These results also highlight the importance of chronic therapy in treating Non-24,” CEO Mihael Polymeropoulos said in a statement on Wednesday.

And, given that there is no other source cited, it appears that the story relied largely on that news release.

Total Score: 2 of 9 Satisfactory


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