The revolution will not be televised, but it may be posted on Twitter and Facebook
We are pleased to announce that our social media monitoring and analytics platform, MedWatcher Social, has been featured in an article on The Pink Sheet, “Adverse Events In Social Media: FDA Expects Signal Detection ‘Revolution.’”
Sarah Karlin describes how the FDA expects to expand on its traditional adverse event collection process by utilizing data from social media spaces like Facebook and Twitter to assist in post-market surveillance. Karlin also discusses how our team at Epidemico has worked with the FDA to provide them with the necessary technology for such surveillance using our MedWatcher Social platform.
Our capabilities with MedWatcher Social are best illustrated by Karlin’s coverage of a brief study that one of our co-founders, Nabarun Dasgupta, recently conducted for a presentation at the Drug Information Association (DIA). Nabarun examined MedWatcher Social data for 15 drugs that had been captured over six weeks. Out of 27,200 drug mentions from Facebook and Twitter, 47 posts described events that resembled adverse events (which we call “proto-AEs”); the majority of those posts (89%) described events related to Tecfidera (dimethyl fumarate), Biogen Idec’s multiple scerlosis drug. Nabarun then compared the social media data to the clinical trial data found in the Tecfidera drug label. The results were impressive:
As illustrated in the graph, MedWatcher Social captured proto-AEs that were not observed previously during Tecfidera’s pivotal trial. This has significant implications for the value of social media platforms in evaluating the safety of an approved product based on what patients are saying — and the fact that the rank-order of proto-AEs reported in social media correlates to that of those reported during the pivotal trial suggests that what these patients are saying can be quite valid indeed.
While there are still many limitations to social media (which Karlin’s article outlines), the potential for the FDA to use it as a barometer for early safety signals is tremendous.
The original article can be found on The Pink Sheet.
To learn more about our MedWatcher Social tool, please click here.