FDA rolls out Sentinel project - FDA Trends

It's been in the works for years: A 21st century way for the FDA to track drug side effects. That's right, a database, or series of databases, that agency types can sift for adverse-event patterns. Rather than waiting for doctors and patients to voluntarily report possible safety problems, the agency could actively monitor prescription drug use and its effects on people.  

Sounds none too difficult in this age of sophisticated data-management software and Google search algorithms. But like many government agencies, FDA isn't exactly on the cutting edge of computer technology. Plus, access to patient information can be problematic; privacy concerns and all that. Building it all from the ground up wasn't an option. 

The agency's solution: Partner with people who already have the info, i.e., Medicare and Medicaid and private insurers. FDA has already inked a deal with WellPoint to query its data on more than half of its 35 million members. It got access to info on even more patients via a recent agreement with the Center for Medicare and Medicaid Services. Agreements with additional private insurers are already in the works. 

To allay fears that data-mining will turn up a lot of fool's gold, leading to unnecessary safety alerts, WellPoint queried its 1999 data and concluded it could have spotted the withdrawn painkiller's cardiac problems within four months of the drug's introduction. Offering further reassurance, the FDA said it will first focus on mining the databases for information on known safety problems. But CDER chief Janet Woodcock acknowledged that at least at first, there will be some false alarms. But she promised to work to minimize the possibility. 

Questions remain -- questions that likely will only be answered once the FDA has had the opportunity to really dig into the data. For instance, how to know when a pattern is a real problem? How can Medicare beneficiaries' side effects be teased apart when they take, on average, 28 meds a year? Presumably that's why the agency will focus on known problems first. 

The real fruits of this labor won't be reaped for years, researchers said when the agency announced its Medicare plans. And it won't be easy. One epidemiologist told the New York Times, "This is going to take a lot of work." Good thing the FDA is planning to expand its staff, eh? 

- see this FDA report
- read this release for more 

FDA rolls out Sentinel project - FDA Trends
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