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When a new drug hits the market, it can take years before enough evidence is gathered to show that it poses risks to certain patients. Such was the case with the arthritis drug Vioxx, which doctors prescribed for several years before data proved it significantly raises risks of heart attacks and strokes, forcing Merck to yank Vioxx from the market in 2004.
Since then, insurance companies and health care providers have been developing electronic systems that can help the Food and Drug Administration and drugmakers identify medication safety problems much earlier by analyzing patient clinical and claims data. Toward that end, WellPoint, one of the nation's largest health insurers, revealed last week that it's investing millions of dollars in a three-year project to build a drug "surveillance" system in collaboration with the FDA and several academic institutions, including Harvard, the University of North Carolina, and the University of Pennsylvania.
The Safety Sentinel System will mine and analyze aggregate claims, lab, and pharmaceutical data from WellPoint's 35 million members, who generate 1.4 billion "claim lines" of data each year, says Marcus Wilson, president of HealthCore, WellPoint's medical outcomes research subsidiary, which WellPoint acquired in 2003 and which is overseeing the new project.
"There's no such thing as a safe drug," he says. Instead, there are "benefits and risks" for all medications. Still, the system aims to help understand, for instance, if certain drugs pose higher risks to large populations of patients, particular demographic or ethnic groups, or certain types of individuals, such as those undergoing combinations of medical treatments.
In a statement, FDA officials said the WellPoint system jibes with the agency's goal of having a network of public-private partnerships to help identify and address drug-safety issues faster. Initial tests of the Safety Sentinel system showed that it can detect potential adverse events within months of a drug's release, versus the years it can take the FDA because of its reliance on reporting by doctors.
While WellPoint's effort will use claims, prescription, and lab data, some of the nation's largest health care providers are using patients' clinical data to detect adverse drug events. Partners HealthCare, which operates several Boston-area hospitals, including Massachusetts General and Brigham and Women's, has at least three such projects under way, says Partners CIO John Glaser. Among them is an alliance of Partners, the FDA, industry group eHealth Initiative, and three pharmaceutical companies--Eli Lilly, Johnson & Johnson, and Pfizer--which chipped in $250,000 each. The principals are analyzing data from the e-health records of Partners' 4 million patients for adverse drug effects--for example, the percentage of people on cholesterol-lowering statin drugs who develop liver problems.
The biggest challenge for these drug surveillance systems is interoperability, says HealthCore's Wilson. That's because the data that needs to be analyzed comes from multiple sources, with multiple components. No single, national database will ever contain all claims, lab, pharmaceutical, and other clinical data for all patients. So the focus, he says, is on "how to make it all sync and work quickly."
Photograph by Mike Segar/Reuters/Landov