FDA to Work With Online Patient Forum to Mine Drug Side Effect Information

June 16, 2015

The U.S. Food and Drug Administration is turning to a patient-networking website to get a better handle on the side effects of medications.

The FDA is tapping into a broad flow of data sent to PatientsLikeMe, an online site with 350,000 members that says it’s the largest and most active patient network online.

Members often report their drug-use experiences, symptoms and hospitalizations on the site.

The agency said it hopes to learn more about side effects that might look harmless to a government drug reviewer but are troublesome to patients. Although the research is in the exploratory phase, it carries potential for influencing changes in drug labeling or how fast the agency might react to a safety issue.

“We’re hoping we can find information on the impact of adverse events on patients’ day-to-day lives,” said Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA. “We don’t know if it will give us the kind of information that will be sufficient to make label changes. That’s what we’re trying to find out.”

Currently, the agency relies on patients, doctors and drugmakers to report limited details of side effects known as adverse events. PatientsLikeMe, of Cambridge, Massachusetts, has collected more than 110,000 adverse-event reports on 1,000 different medications, according to a statement on Monday.

Teasing Out Signals

“A traditional case report is a snapshot in time of when an adverse event happens,” Ben Heywood, co-founder and president of PatientsLikeMe, said in an interview. The online forum details patients’ symptoms and medications before and after the event, he said, so that “the FDA could see additional signals or earlier detection of an event.”

With more patients using online forums to seek out fellow sufferers for support or discuss their medications, drugmakers and even hedge funds are listening in, trying to tease out a signal among the reams of data.

PatientsLikeMe, a closely held company backed by investors including EBay Inc. founder Pierre Omidyar, sells data, without patient names, to institutions and drugmakers. It also collaborates with companies on research, including a Biogen Inc. study that used Fitbit wristband health trackers on multiple sclerosis patients. More FDA collaborations may be on the horizon.

“There’s a lot of interesting app development for reporting adverse events,” the FDA’s Dal Pan said. “I think we’re going to have to explore the value of social media.”
PatientsLikeMe takes identifying information out of the data it gives to its partners, including the FDA, said Heywood. The company hasn’t discussed with the agency what would happen if the regulators wanted to follow up with an individual, he said.

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