This is an interesting announcement and reveals to me the fact that the FDA is coming to grips with the fact that the current process for reporting adverse events needs an overhaul including refining what qualifies as an AE and how they are reported. I believe the landscape for AE reporting is about to change dramatically owing to another trend which is quite outside the FDA’s control, namely social media. A number of articles show that due to the growth of online medical communities and web 2.0 means of sharing science and medical knowledge, the idea of capturing AEs via phone call or other report to a drug company from an HCP is becoming increasingly obsolete. Reportable adverse events are far less common than most people suspect. As of 2009 there were only approximately 166 reportable adverse events per day recorded across the entire pharma industry. Increasingly pharma companies are examining how (and to what extent) they will be required to capture and monitor AEs in online discussions occurring on their brands. The amount of content to monitor is potentially staggering and yet algorithms are being developed that will automate this to some extent. This has the potential to be much more useful than simply tracking isolated AE incidents for the FDA since it will allow both regulators and industry to gain much more sophisticated intelligence on the experience of mass numbers of customers with the products.
An excellent article in Businessweek highlights the fact that Social networks like PatientsLikeMe let people take charge of their own care—changing the nature of drug research and the practice of medicine
Not exactly rocket science but Chemgenex has developed a nice mashup of mapping for clinical trials searching instead of the usual process of dumping them in Clinicaltrials.gov and hoping some patient or researcher finds them.
As more web driven mass crowd sourced health data is collected by large search and portals and organized it is being packaged and anonymized to provide services that normally took many months to years and required whole separate agencies and departments to run. So for example Patientslikeme is now making possible users with health conditions to provide reports on conditions in a standardized manner which provides web based “user driven” trials that can quickly provide important feedback on therapies. Similarly Google can now beat CDC in predictive value for flu outbreaks. Read on…