Adverse events: main obstacle to pharma engagement in social media or the stick that beats them to it?

Last week, patientslikeme http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/, the over 10,000 patient-strong MS online community, started to repor

By Silja Chouquet on Apr 21, 2009

Last week, patientslikeme http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-..., the over 10,000 patient-strong MS online community, started to report adverse events directly to the FDA.

Adverse event reporting, or the lack thereof, has been mentioned by pharma as the number 1 threshold to more social media engagement. So the fact that online communities now start setting up reporting structures and processes should have a very positive impact on social media use within the pharma industry.

This might also note a tipping point in pharma's view of social media though. Up until now, pharma has viewed engagement with this new promotional channel as highly interesting and innovative, yet completely optional. With the element of adverse event reporting, this might change as monitoring of the online community might become crucial to protecting your label.

According to my analysis http://www.whydotpharma.com/2009/04/21/social-media-could-increase-adver... Copaxone, the leading MS prescription treatment on patientslikeme, the communities reporting could lead to up to 23% more adverse events that could POTENTIALLY get reported to the FDA. (see the full analysis in this slideshow http://www.slideshare.net/Silja/impact-of-social-media-adverse-event-rep...)

This raises a lot of questions on the impact direct adverse event reporting could have.
Is 23% alot? Enough to impact the Copaxone label? How will the FDA feel about receiving this peak of AEs? What will they expect pharma to do?

Adverse events are currently completely under reported with only about 10% of serious and 2-4% of non-serious AEs getting reported. The actual impact of AE cases reported via social media will thus depend on the transformation rate of severe and moderate side-effects to a reported AE case. How many AE cases will patients report, especially the non-serious ones?

There might also be some biases in the data as the patientlikeme population might not be representative of total patient population.
Are inherent biases in patientlikeme population (ie. Age, educational level etc.) likely to skew the AEs reported?

The clinical impact of new AE cases reported will depend on the type of event reported.
Will there be more reactions than captured in the label? Are patients going to report reactions currently not part of label? Are they going to report more on certain reactions vs. others?

For right now, only one social media online community is reporting AEs, but many more will follow, if the patientslikeme pilot is successful.

Yet, if large number of online communities start to report AEs, the FDA might turn right around to Pharma to check AEs for accuracy and quality as it is done for HCP reported events. They might also ask to evaluate the impact and need for follow up studies on what is being reported.

My advice for pharma?

- Be proactive and start setting up processes to deal with FDA request regarding social media

- Know your online community: Set up social media monitoring tool now to find out about which side-effects and AEs patients discuss online.

-Get data on how many of your patients are active in which online communities and what the potential impact could be, if they all started reporting tomorrow ;-)

- Talk to online communities and FDA about potential collaborations as well as the implications of patient-driven AE reporting

Capturing AEs via online communities will help to increase patient safety and will ameliorate treatments over the long-term. It is thus very good that online communities participate. It should also lower pharma's barriers for engagement, as now there is a way to do it correctly.

Just be aware that it might also turn social media engagement very quickly from a nice to have to a must have organizational capability for your organization.