Merck must have loved this story – getting nine mentions and getting away claims that were unchallenged by any independent source.
Sleep disorders are a big problem and also are big business. People who suffer from sleep disorders deserve a clear, marketing-free picture of any scientific advances being made.
No. And this really is a shame because there are a lot of sleep aids on the market. Given the doseage, there could have been a way to talk about what drug this might replace or compete with and how much that drug costs, at a minimum.
There are 28 numbers in this 495-word story, not including the name of the drug. These numbers add up to very little. For one, there are a lot of comparisons of performance levels at different doses of drug. This seems to be aimed at scientists who may be working on similar drugs and are trying to come up with the perfect dose. Why would anyone else need this information? The absolute numbers are missing, as they often are, leaving us to wonder whether a 12.2% higher than placebo means much. Let’s say you’re an insomniac and you only sleep four hours a night. If you take this drug, you will have slept an extra 29 minutes. At least that appears to be what this means. It’s hard to say because of that odd caveat: "larger percentage of eight hours spent in bed at one night and at the end of four weeks of treatment." When the second sentence in a story reads like that, you know you are in trouble.
It mentions side effects, but it does not put any number to them. The press release, at least, notes that the incidence of these side effects was 3% or less, but, again, a little more context would be nice. And what about drug dependence? What about contraindications with other drugs, vitamins, foods? What about withdrawal problems?
One of the problems was drowsiness upon awakening. Last time we checked, insomniacs don’t need the help of a drug to achieve this result. It is unclear whether these adverse events are observed only during the active (pill taking) phase of the study or after. It is also important that the effects of chronic use are not mentioned, and the reader will be interested in these (as the problem is chronic) and the harms may multiply over time. Finally, because orexins, the brain chemical on which the drug is supposed to work, are involved in appetite and food-consumption, the occurrence of problems, or lack thereof, in this arena are particularly relevant and merit a mention.
We read this story and the press release several times and we’re st ill not entirely sure whether this is a big deal. If we had access to company executives, though, and outside experts, as this reporter did, we would try to probe the finer points of these findings and provide readers some context. For example, it says that it took patients 21.6 fewer minutes to fall asleep, a fact straight out of the press release, and, like the press release, without the context of how many minutes these insomniacs typically require to fall asleep. One hour? Two hours? All night?
There is inadequate description of the design of the study and the statistical analysis to permit the reader to get a sense of the strength of the evidence. We don’t know whether this was a randomized trial nor whether the evaluators were biinded to whether the subjects got placebo or active drug. These are potential key strengths that we don’t learn about.
What is the definition of insomnia? The definition given in the story fails to mention that the difficulties with sleep need to be chronic to meet the definition. How many Americans have experienced difficulty initiating or maintaining a good night of sleep? A small percentage of these will meet the disease definition.
No independent sources, and they are sorely needed.
No. See comments above under "novelty." Also, there is no sense in this story that drugs aren’t the only solution to this problem. MayoClinic.com ticks through a number of alternatives to drug therapy, including "Going to bed only when sleepy, Using the bedroom only for sleeping and sexual intimacy (as opposed to reading, writing, studying, watching TV, or other activities), Going to another room when unable to sleep and engaging in another activity until sleepy." You can find more here: http://www.mayoclinic.org/insomnia/treatment.html.
The first sentence presents the information as coming from "a mid-stage study," a vague term. Later, though, it says that Merck is going to apply for approval for the drug in 2012. This is satisfactory in the strictest sense of the word. To really understand the origin of these results, you need to go read the press release, which calls the study a "Phase IIb" study and alludes to ongoing Phase III studies. The story seems to conflate these two things.
This is perhaps the story’s biggest failing. We have been bombarded with sleep aid ads in recent years. Ambien, Sominex, Unisom. These are all household names. How can one write a story about a new sleep drug and not talk about what’s already on the market? Making matters even more frustrating, the story says "MK-4305 belongs to a new class of sleep drugs that inhibits production of orexins in the brain, blocking stimulation of the brain’s arousal system. Orexin is a neuropeptide that is believed to play a key role in regulation of the brain’s sleep/wake process." But it never says whether other drugs in this class are already on the market or how many drugs like this have been tried and failed.
The story does not appear to present a single fact not found in the drug company’s press release, and it only quotes one person, the Merck VP who is quoted in the press release. One quote appears to be original and the other is straight out of the release, here referred to as "a statement." Here is the release: http://www.merck.com/newsroom/news-release-archive/research-and-development/2010_0609.html