Readers aren’t told until deep in this story that researchers were experimenting on rats and monkeys, not people. It does provide more independent perspective than the Reuters story we also reviewed. Both stories report that the research was done by the company seeking FDA approval for a new sleeping pill. We are puzzled that neither story asked why the important questions about drug side effects apparently weren’t answered by the human clinical trials done to support Merck’s FDA application of a similar drug.
Most adults have an occasional bout of insomnia, some have persistent difficulties. Although cognitive behavioral therapy has been shown to be far more effective in the long term, occasional use of sleep aids is helpful for many people. The existing drugs available, while far better than in past years, are not ideal especially for elderly patients. A more targeted drug therapy would be welcomed.
But we should say it 100 times: animals aren’t people. While animal experiments are an important early step in research, especially for testing new concepts, when a drug is awaiting FDA approval for sales to people, it is time to report on what is actually known or not known about how the drug affects people.
Given the cost of the newer sleep aids (in excess of $250/month), the cost of a new drug is an important consideration. While the study in question was conducted in rats, a close relative of DORA-22 is under consideration for approval by the FDA. It is for that reason we think that cost should have been part of the storyline.
The lead sentence is simply wrong. It says this type of drug “appears to help people fall asleep without causing grogginess the next day.” But besides the fact that this experiment didn’t actually include any people (just animals), the researchers specifically pointed out that the “current study design is limited in that it does not address the issue of next-day “hangover” or carryover effects.” In other words, grogginess the next day was not tested.
Further, allowing the lead author, an employee of the drug company studying the drug to say, “We’ve shown that these compounds improve sleep at doses that don’t impact cognition,” allows the reader to assume that the benefits of DORA-22 have already been shown.
While the study did not examine the effects of DORA-22 in any detail it did in fact look at level of cognition in the animals studied. While the story notes, “DORA-22 did not lead to the same mental impairments as the other three drugs. Rhesus monkeys and rats performed just as well on memory and attention tasks shortly after being administered DORA-22 as they did on an inactive placebo,” it fails to note that cognition was impaired at higher doses. This is a major error in interpretation of the study results.
Although we would prefer to see potential harms mentioned as high up in stories as potential benefits, this story does highlight questions about harms at the end, so at least those who read the whole story are alerted to the many unknowns.
Because of that ending, we’ll give it the benefit of the doubt and grade it satisfactory on this criterion.
Although there are qualifiers late in the story – (“But many questions remain: Do the drugs truly have fewer side effects? Will they be habit forming? And will they change the quality of sleep in any way? Those questions will only be answered with more testing and use in humans. Experts note that findings from animal studies do not always hold up in human trials.”) – the overall impression is that the data generated in rats and monkeys are transferable to humans. A bit of restraint in the early statements would have provided a much more concise and informative story
And, as noted above, this story misstates the question that researchers investigated.
No overt disease mongering is seen. While the “30 million Americans” figure used in the story oversimplifies the extent of insomnia, it is in the range of estimates commonly used by experts.
The story reports that the researchers work for Merck, the maker of a drug similar to the one they tested. It also includes comments from two independent sources. This story does a better job of providing independent perspectives than the Reuters story we also reviewed. But neither unaffiliated expert points out the study design and the inherent liabilities in interpretation to humans.
The story focuses on the use of drugs to help people with sleep disorders. While popular, other approaches including cognitive behavioral therapy have been shown to be far more beneficial in the long run that simple drug therapy. And there is no mention of the many non-drug approaches to dealing with sleep problems.
The story makes it clear that the drug is under study and therefore not available. The story tells readers that Merck has applied for FDA approval to market a similar drug.
The story makes it clear that DORA-22 is one of a new class of drugs designed to help with sleep disorders. The story does describe how this drug works on a different part of the sleep-wake mechanism in our brains than currently-available drugs. However, it is odd that there is no mention of any of the human clinical trials that must have preceded Merck’s FDA approval application.
The comments from the two unaffiliated experts demonstrates the story did not rely solely on a press release.