Seventy-three percent of off-label recommendations for 160 commonly prescribed drugs were made with little or no scientific evidence to support their use. That's one of the conclusions in “Off-label Prescribing Among Office-based Physicians,” published in the May 8 edition of Archives of Internal Medicine. (The findings were based on an analysis of nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index.) Given that this data came from 2001, when some questionable practices on the part of pharma may have been more prevalent than they are now, some of this might be due to inappropriate detailing and other sales practices. But certainly not all 73 percent.

So where could these prescribers be getting their information? I would hazard a guess that it's not from direct-to-consumer advertising, or from exhibitors at national conferences, where the FDA is looking over pharma's shoulders. It shouldn't be coming from sales reps, who have been spanked soundly in the aftermath of recent investigations and settlements. Certified CME is one of the few safe harbors for discussing off-label drug use, so that would be where I'd look first.

Part of the problem is that there just isn't a whole lot of evidence available for off-label use of many drugs — if that degree of evidence were available, you can bet your bippy that the drug companies would be looking to get them approved for those uses. So CME activities that delve into off-label use often have to rely on lower levels of evidence, sometimes just anecdotal evidence from a key opinion leader. But just how far can you trust a KOL's opinion? Of course it depends on the individual, but CME providers and healthcare workers alike have a tendency to put KOLs on a pedestal, and take their recommendations as the gold standard for care, regardless of how they arrive at those recommendations or the levels of evidence involved.

I know CME providers are reluctant to challenge their KOL faculty — heck, they're lucky to even get these good folks to be involved their activities in some cases. But with so many prescribers relying on their opinions, it's not enough to resolve any conflicts of interest these faculty might have. It's also vital that you ensure that the audience understands the level of evidence KOLs have to back up their recommendations for off-label use, and how that should weigh on their future prescribing behavior.
Sue Pelletier,
(978) 448-0377,