New warnings were issued by the FDA for prescription sleep aids yesterday. The media coverage of the issue focused on the claim by some users of these drugs that they experienced "sleep-driving" – getting dressed and getting in a car and driving while asleep.
But what we have here is the boiling down moment – where an adverse event is reported by media in a sound byte and then communicated to the world – making that the focus rather than much more complex issues that are involved.
This event, like other sudden class warnings, raises a lot of interesting questions.
- First, prescription sleep aid drug usage has increased dramatically over the
past few years. Is that attributable to an increasing amount of
sleep-related problems on the part of patients? Or is it an outcome of an increased
availability of prescription sleep aids coupled with an aggressive
direct to consumer (DTC) advertising campaign? This question is really rhetorical…
- Second, can blockbuster drugs be applied evenly throughout the population without the expectation of adverse events? Drugs that perform perfectly well in controlled clinical trials can have different effects when put out to the larger population. Are almost all drugs that reach a usage level this high destined for increased warnings as a result?
- Third, should drugs like sleep aids be advertised so heavily? One of the primary benefits of DTC is that it can educate people about the existence and role of an intervention and about symptoms of a condition so that they can talk to their doctors. Certainly people are aware that sleeping pills exist. It is not like patients are being educated about the role of statins in lowering cholesterol. How is it possible to regulate those drugs which are good candidates for DTC and those which are not?
- Fourth, does the FDA, which slapped a bunch of risk management tools on these drugs, know what the real impact of those interventions is? Can stronger warnings make a difference, and if so, what is that impact? Why are safety issues continually addressed by a bunch of risk management devices when we have very little scientific evidence on their efficacy?
That is a lot to consider for one blog posting. But when these types of events occur, I get the feeling that we are all focused on the drama of "sleep-driving" while we are we snoozing through the important questions.