FDA digs into PatientsLikeMe's data to add patients' voices to safety monitoring

PatientsLikeMe has pulled off a major coup. The patient-networking website added FDA to its roster of A-list clients this week in a deal that sees it provide the regulator with access to the 110,000 adverse event reports filed by its 350,000 members.

FDA will scour the data in an attempt to build a more qualitative picture of the effect adverse events have on patients, while also keeping an eye out for side effects its own systems are yet to spot. The level of real-life detail possessed by PatientsLikeMe is the big attraction for FDA. An event that appears relatively harmless to a regulatory official may actually have a notable detrimental impact on a patient's day-to-day life. Such nuances are beyond the scope of FDA's own postmarket safety monitoring system Sentinel--which contains coded data--but may be found in PatientsLikeMe's data.

"We're looking to see if we can supplement [our data] with more information about the patient's voice, having the patients tell us their experience in their own words," Director of the Office of Surveillance and Epidemiology at FDA Gerald Dal Pan told MobiHealthNews. Descriptions of these firsthand experiences could reveal a wealth of information normally hidden from regulators, such as the symptoms a patient was experiencing in the days leading up to an adverse event. The level of detail may also show whether the problem is with a drug, concomitant medications or improper use.

FDA's Gerald Dal Pan

Exactly where this will lead is unclear. Pan has described the three-year collaboration with PatientsLikeMe as "exploratory" and admitted he and his regulatory colleagues are unsure "what we're going to find." As such, it is too early to tell whether information collected by PatientsLikeMe could lead to labeling changes, although Pan isn't ruling out the possibility. FDA is yet to even establish if the PatientsLikeMe data can show some basic, essential things--such as whether an adverse event predated the start of treatment--and will focus initially on running feasibility studies.

Regardless of how PatientsLikeMe's data fares in such studies and how influential they become to FDA, the regulator's willingness to work with the patient network marks another step in the evolution of its approach to IT and social media. With everyone from Big Pharma to hedge funds looking for insights in such data, FDA clearly feels it cannot sit on the sidelines. "There's a lot of interesting app development for reporting adverse events. I think we're going to have to explore the value of social media," Pan told Bloomberg.

- read MobiHealthNews' article
- here's Bloomberg's piece
- check out FiercePharma's take
- and the statement