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Data Mining Prescribed To Ensure Drug Safety

WellPoint's "Safety Sentinel System" may help the FDA and drug makers identify medication safety problems much earlier by analyzing patient clinical and claims data.

When a new drug hits the market, it can take years before enough evidence is gathered that the medication poses dangerous -- or even deadly -- risks to certain patients.

Such was the case with Vioxx, which doctors prescribed for several years before data finally proved the arthritis drug significantly raised risks of heart attacks and strokes, forcing drug-maker Merck to yank Vioxx from the market in 2004.

Since then, health care players -- including insurance companies and providers -- are ramping up development of new electronic surveillance systems that can help the Food and Drug Administration and drug-makers identify medication safety problems much earlier by analyzing patient clinical and claims data.

This week, WellPoint -- one the nation's largest health insurers -- revealed it's investing millions of dollars in a three-year project to build such a drug surveillance system in collaboration with the FDA and several academic institutions, including Harvard University, University of Pennsylvania, and the University of North Carolina. 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, said Marcus Wilson, president of HealthCore, WellPoint's medical outcomes research subsidiary, which WellPoint acquired in 2003 and is overseeing the new project.

"Claims data is the root, but there is also pharmaceutical data from prescriptions that patients fill, and other robust data, like lab results data, that can help us analyze safety issues," he said, including whether a certain drug causes kidney toxicity in patients.

"Drugs are not safe. There is no such thing as a safe drug," he said. "There are benefits and risks" for all medications. However, the system aims to help understand, for instance, if certain drugs pose higher adverse risks to large populations of patients, particular demographic or ethnic groups, or certain types of individuals, such as those undergoing combinations of different medical treatments.

HealthCore has a team of 65, including technology professionals and medical experts working on the Safety Sentinel project, Wilson said.

"We're doing this to benefit our members, and we also have a keen interest in public health," he said. Eventually, HealthCore might offer services to pharmaceutical companies, the FDA, or other organizations that want to use the Safety Sentinel infrastructure for their analysis, he said.

In a statement from the FDA, officials say the WellPoint system fits into the agency's larger goal of having a network of public-private partnerships to identify and address drug safety issues faster.

Initial tests of the Sentinel system showed that it can detect potential adverse events within months, versus the years it can take for the FDA to identify problems because of heavy reliance on the reporting of incidents by doctors.

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