Wellpoint Develops A Safety Monitoring System

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safety-first.jpgThe big health insurer wants a system in place that will use its 35 million-member database to monitor and help to more quickly identify potential safety problems of approved drugs. The Safety Sentinel System, which is being developed in collaboration with the FDA and other government and academic institutions, should in theory be able to uncover health risks that might crop up once drugs are being used by the general population more quickly than the FDA, doctors or drugmakers, Reuters writes.

“When we see a signal within our claims data that suggests there may be an issue, we can very quickly work with our provider community to figure out if in fact it’s real,” Marcus Wilson, who heads WellPoint’s HealthCore unit, tells Reuters. Had the system been in place in 2004 when Merck withdrew Vioxx, the insurer may have been able to detect heart risk sooner. In a simulated test using data following Vioxx approval, Vioxx patients were compared with those on similar meds, and “we were able to see a clear separation in number of heart attacks and strokes within six months,” Wilson says.

The new system, to be launched in mid-2009, is expected to be capable of continually monitoring Wellpoint’s 35 million-member database and identifying increases in health problems among members taking a given drug, indicating a potential for serious adverse events, Reuters writes. It is still being worked out how info gleaned from the system will be shared with the FDA, physicians, members and drugmakers. “Sometimes we can do more harm than good by communicating things too early,” Wilson tells Reuters, “and certainly we don’t want to wait until it’s too late.”

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