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WellPoint developing drug safety monitoring system
2008-04-15
Health insurer WellPoint Inc said on Tuesday it is developing a system that will use its 35 million-member database to monitor and help to more quickly identify potential safety problems of approved medicines. WellPoint's Safety Sentinel System, being developed in collaboration with U.S. health regulators 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. "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, president of WellPoint's HealthCore unit, which is developing the system, said in an interview. Merck & Co withdrew its widely used pain drug Vioxx in 2004 -- after more than five years on the market -- after a study showed it doubled the risk of heart attack and stroke. Had the WellPoint system been in place, it might have picked up the heart risk years earlier, Wilson said. In a simulated test of the system using data WellPoint had available after Vioxx was first approved comparing patients on Vioxx with those taking other similar pain drugs, "we were able to see a clear separation in number of heart attacks and strokes within six months," Wilson said. The Food and Drug Administration has increasingly been requiring companies to conduct post-marketing studies as a condition of approving some drugs. Data collected and reviewed under WellPoint's system could further enhance understanding of dangers associated with popular medications. "The discovery of important risks of drugs like Vioxx and Avandia has demonstrated that the health care system currently has no reliable means of quickly measuring the safety of drugs once they're in widespread use," Dr Jerry Avorn, professor of medicine at Harvard Medical School, said in a statement. Heart risks associated with the diabetes treatment Avandia and Vioxx were not discovered until after they had been used by tens of millions of patients. WellPoint is the largest U.S. health insurer by membership. The new system, to be launched in mid-2009, is expected to be capable of continually monitoring its 35 million-member database and identifying increases in health problems among members taking a given drug, indicating a potential for serious adverse events. Beyond the data from its membership, WellPoint will work closely with healthcare providers and hospitals to generate evidence based on its findings, Wilson said. It is still being worked out how information gleaned from the system will be shared with the FDA, physicians, members and drugmakers, Wilson said. "Sometimes we can do more harm than good by communicating things too early and certainly we don't want to wait until it's too late," he added. The Safety Sentinel System also will be able to examine potentially hazardous combinations of treatments, especially in patients with certain diseases or health conditions, such as diabetes, WellPoint said. "This critical information will allow health care decision-makers, including federal agencies, physicians, consumers and manufacturers, to move far more quickly than in the past in addressing potential drug risks," said Sam Nussbaum, WellPoint's chief medical officer.
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