‘Little Measurable Impact’ from Sentinel: Analysis

A Stat online investigative report says FDA’s highly-touted Sentinel initiative, which mines insurance data and medical records to identify possible drug risks, “has had little measurable impact…. Ten years and $207 million later, critics question whether Sentinel can adequately identify risks involving drugs that are already in consumers’ medicine cabinets.”

To date, the report says, Sentinel records have been used to revise only two drugs’ warning labels. Institute for Safe Medication Practices senior scientist Thomas Moore told Stat the system “is valuable, but much less so than originally advertised.”

Critics say Sentinel lacks important data. The report says the system relies primarily on insurance company billing records that have limited information; patient records include few people over age 65; medical providers who supply data to the system use different diagnostic codes for the same conditions; and, perhaps most important, the vast majority of records for people who died as the result of medications never make it into the system.

“The truth of the matter is, we don’t ever really know how well Sentinel is working,” says Yale University assistant professor of medicine and public health Joseph Ross. “We don’t know if there is a safety problem that Sentinel is picking up or not.”

However, Sentinel principal investigator Richard Platt from Harvard Pilgrim Health Care Institute says Sentinel has already been valuable in helping confirm the safety of certain medications so they could be kept on the market. And he says it can be used to access 193 million patient records and compare side effects between two drugs used for the same condition, an extremely useful approach when trying to identify possible risks associated with medications. “There’s an increasingly sophisticated capability to ask certain kinds of questions and get reliable answers in a relatively brief period of time,” he says.

FDA Office of Surveillance and Epidemiology deputy director Robert Ball told Stat that Sentinel has only been working at full capacity for one year and will prove increasingly valuable over time. “It’s taken a while to build the system,” he said. “We expect there will be more situations where the data from Sentinel will be used toward regulatory decision making.”