1-800-NOT SURE
By Peter Pitts on May 20, 2008 – 7:47 am
On Friday I offered “public comment” to the concept of placing a 1-800 number is all DTC television ads. While to many this idea sounds like a no-brainer — it ain’t so easy. Some things to consider:
* The use of the terms “adverse event” and “side effect” being used inter-changeably. Just what do consumers think they mean? The committee seemed to think that the FDA should look into this.
* How can poly-pharmacy patients report an adverse event when they can’t be sure what’s caused it?
* Will an 800 number (presented via a super, audio, or both) cause a “power of suggestion” situation, thus producing a kind of adverse event “placebo effect.”
These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility. A serious “signal-to-noise” issue. Of particular worry was how the FDA would then use this information relative to communicating “early safety signals.” Talk about unintended consequences!
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One Comment to “1-800-NOT SURE”
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May 20th, 2008 at 8:31 am
It is certainly likely that a 1-800 reporting system will be characterized by signal-to-noise problems. That is true for any post-market surveillance, but we do need a system to look for the kind of rare, but serious adverse events only detectable after a drug is in wide use.
The question FDA is considering is whether DTC ads on TV should carry the same 1-800 number as print ads. I can’t think of a reason they shouldn’t.
DTCA advertising drives the use of expensive drugs that are frequently no better (and may be less safe) than established therapies. As long as we’re paying the costs of such ads, we might as well try to make them serve some good as well.