Wednesday, December 21, 2011

Digital Adverse Event Data and Entrenched Aversion: A Puzzling Incongruity

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Casey Ferrell is a research analyst at Cutting Edge Information. He will be guest blogging at IIR’s upcoming ePharma Summit 2012 (February 6-8, 2012 in New York City). You can find him on Twitter or over on his company’s blog.

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If there is one thing that exasperates me as a researcher, it is that irascible, irrational thing called human behavior, especially when it acts to perpetuate a notion that a mountain of empirical evidence dispels as fallacy. To be sure, we are all guilty of this form of willful ignorance from time to time. (Don’t try to tell my grandmother, for example, about the risks associated with too much butter in your diet — she’s the original Paula Dean.) There are plenty of examples of this phenomenon in the business world; in Pharma, one well-known red herring is adverse event reporting online.

From my recent research into pharmaceutical companies’ digital marketing benchmarks, I asked survey respondents to rate various challenges to more widespread social media adoption. Near the top of the list? You guessed it: adverse event monitoring and reporting, which joins off-label communication and ROI as the three highest-rated limiting factors. This data was collected and analyzed during the fall of 2011. That is to say, barring a sea change in opinion in the last 60 days, pharma marketers still perceive adverse events (AEs) to be a major issue — even a nonstarter, perhaps — obstructing the industry’s way forward in digital media.

But what about all that research showing how limited the occurrence actually is for AEs online? Let’s briefly recap: Visible Technologies recently published a white paper detailing a sweeping online AE incidence study that confirmed earlier research, finding this time that the incidence rate for a reportable AE was less than 1% of mentions. This study was broader in scope with more finely tuned metrics than its predecessors, which are nicely corralled here. To round out the picture, Greg Rice of Klick describes a best practice for involving pharmacovigilance in the process, because that group needs to be alerted to brand mentions that may not meet the four reportable AE criteria. Together, this body of research should lead people in pharma — be they in safety, compliance, marketing or anywhere else — to draw a fairly linear conclusion: reportable AEs are not present online in numbers large enough to make adequate, compliant monitoring and reporting impossible. To put a positive spin on that same conclusion, there is one less thing standing between pharma companies and a more robust presence on social networks, blogs, websites and other digital media. Granted at bigger brands there is still going to be logistical problems associated with sheer volume, but those are precisely the brands that should have the resources necessary to staff up their monitoring efforts. At most others, monitoring and reporting online AEs would seem to require tweaks — not overhauls – of existing standard operating procedures in place for pharmacovigilance, safety, compliance, regulatory and marketing departments.

All of this gets the heart of the question: if study after study find a miniscule incidence of online AEs, why does the issue continue to persist as a cited barrier to deeper listening efforts or broader digital engagement? Is it that AEs represent a real threat to pharmacovigilance and safety compliance? Conclusions drawn from recent research would indicate it doesn’t. Are we missing some subtle operational impracticality? Or is it that AEs represent something more symbolic? Is this all merely a reflection of a natural aversion to collecting bad news about one’s products?

If it is the last, then I offer a concluding counterpoint by way of an interview with Arnie Friede, the former FDA associate chief counsel and former senior corporate counsel to pharma, in which he said, “The fear of learning something should not be a deterrent. That’s the ostrich approach. … It’s not a valid reason, to refrain from using an appropriate communication channel because you’re going to hear something you don’t want to hear. If people are experiencing adverse reactions from using your product, you want to know about that and try to deal with it. You can’t escape these things, so why try to hide from them? It’s myopic.”
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