PatientsLikeMe (PLM) — an online community for people with “life-changing conditions” — submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

The most interesting comments are about PLM’s experience with adverse events reported by its members. In short, PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample of 500 posts.

Recall that biopharma company UCB and PatientsLikeMe have partnered to create an online, open epilepsy community that captures real-world experiences of people living with epilepsy in the U.S. Part of this partnership includes a pharmacovigilance program to monitor the site for adverse events and report directly to the FDA adverse events associated with UCB products (see “Finally, a Drug Company Embraces Social Media, AEs Included!“).

PLM said its study data “would extrapolate to approximately 20,000 events per year in our Forum alone. If we were to include data collected from all other sources (e.g. symptoms, treatment evaluations, side effects, annotations, private messages, research surveys) within PatientsLikeMe then the volume would be much higher. Given our current membership of approximately 55,000 patients representing only 15 diseases among hundreds that we plan to build, the contribution to drug safety and public health could be substantial.”

PLM also reported that if patients were given the right tools that facilitate access to their personal medical data, the time required to report an AE to the FDA could be reduced by as much as 44% (from 36 minutes down to 20 minutes). In a pilot program in its 10,000 plus member Multiple Sclerosis community, 195 AERs were generated in one year. PLM found that “75% of these voluntary patient reports contained the four required elements for an adverse event and 24% reported a serious outcome.”

Is this good or bad news for pharma companies hoping to cash in on the social media bonanza? Surely, many were bouyed by the Neilson data, which held out hope that AE’s reported by patients on company-controlled or sponsored SM sites were not an insurmountable problem. The PLM data could bash those hopes.

But if drug safety is important for pharmaceutical companies, then they should welcome the opportunity that sites like PLM offer to improve the safety of their products. “Sites that integrate data collections systems and processes to capture the richness of patient experiences with drug products have an unprecedented opportunity to improve safety and outcomes for everyone who uses these products,” said PLM in its comments to the FDA.