Patientslikeme announced last week: “ a pilot program in our multiple sclerosis community which helps patients submit treatment-related adverse events directly to the The U.S. Food and Drug Administration (FDA) through our site“.
This got me wondering: what will the impact be on adverse event reporting overall? how much of an increase in total adverse events reported could this represent and what will be the implications for pharma and patients?
In the slide show below, I took Copaxone (Glatiramer acetate), the leading MS drug on patientslikeme, as an example for some “back of the envelope calculations“ on just how much of an increase in AEs one could expect to see?
My analysis yields 17-23% of potential adverse events, if you take severe side-effects reported on patientslikeme as a proxy for potential serious adverse events (a 6-13% increase) and moderate side-effects as a proxy for non-serious adverse events (a 10% increase).
Please note that all analysis in this document is my own “guesstimations“ and aims only at getting an idea of the potential amount of AEs. It does not represent the actual number of AEs that were reported by patientslikeme to the FDA.
I believe that patientslikeme took a great stride in making adverse events (AEs) more manageable in the social media arena. The reporting of AEs has been one major obstacle to pharma becoming more involved with the online community.
Also many more online communities will follow the example and start to report adverse reactions. This is great news for patients safety as it has the potential to dramatically increase the data available needed to asses potential risks.
Finally, this starts up a new era of social media involvement for pharma. While up until now monitoring the web for potential side effects or adverse reactions has been voluntary, it might now become a necessity…