FDA, Google Meet About Tracking Adverse Drug Reactions

The FDA is turning to the web to broaden its search for patients who suffer adverse side effects from drugs.

Agency officials met last month with a Google employee who collected data from 176 million unique users on adverse drug reactions and with PatientsLikeMe, which has a database of more than 110,000 adverse events reports.

Google employee Evgeniy Gabrilovich found that while early onset adverse drug reactions are likely to be reported to the proper channels, less acute, later-onset ADRs are more likely to be captured in web searches. Gabrilovich recommended these ADRs be considered candidates for postmarket trials to examine long-term risks associated with drugs.

Gabrilovich, who worked for Yahoo when the research was done, is co-author of Post-market drug surveillance sans trial costs: Discovery of adverse drug reactions via large-scale analysis of Web search queries, published in 2013 in the Journal of Medical Research.

The FDA established an agreement with PatientsLikeMe, giving it access to the adverse event reports on 1,000 different medications. PatientsLikeMe claims 350,000 members reporting on experiences with more than 2,500 medical conditions.

FDA officials plan a follow-up teleconference with Google, but have not released a date. Read Gabrilovich’s report at www.fdanews.com/07-17-15-websearch.pdf. — John Bechtel