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WellPoint Announces Development of Innovative Drug Safety System Designed to Monitor Drug and Therapy Risks Post-FDA Approval
WellPoint's Safety Sentinel System(TM) to be Built by HealthCore, the Company's Health Outcomes Research Subsidiary, in Collaboration with FDA and Top Academic Institutions
INDIANAPOLIS, April 15 /PRNewswire-FirstCall/ -- HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), today announced it is developing a Safety Sentinel System(TM) in response to increasing public demand to more effectively and rapidly monitor the safety of pharmaceuticals and other medical therapies after U.S. Food and Drug Administration approval.
WellPoint's Safety Sentinel System is being developed in close collaboration with leading government and academic institutions, including the FDA and faculty from key academic institutions, including Harvard University, the University of North Carolina and the University of Pennsylvania, and is expected to advance national efforts to identify safety risks associated with drugs and other clinical care decisions, allowing physicians and other health care professionals to make more informed decisions about how to treat their patients.
"To rapidly and successfully identify emerging safety problems, we need to bring all health care stakeholders to the table," said Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA. "The FDA is planning a larger public-private partnership and we're excited that WellPoint is building a system that could inform this initiative."
Jerry Avorn, M.D., professor of medicine, Harvard Medical School and chief, division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women's Hospital, said, "The discovery of important risks of drugs like Vioxx(R) and Avandia(R) 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. I look forward to working with HealthCore and its partners on this project and bringing the value of WellPoint's Safety Sentinel System to a large number of patients."
Ultimately, the system 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 Serious Adverse Event (SAE). It is anticipated that the company's Safety Sentinel System will also make it possible to examine whether particular combinations of treatments could cause serious medical problems, especially in patients with certain diseases or health conditions.
Sam Nussbaum, M.D., chief medical officer for 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. "Our company's Safety Sentinel System will draw upon the vast amount of data generated by WellPoint's health plans, including the use of specific medications. It will enable us to identify potential hazards and allow faster, more informed decision making by health care professionals."
"Our initial developmental work on the system has clearly demonstrated its ability to detect adverse events rapidly," Nussbaum said. "We were able to pick up a safety signal within a few months on certain drugs even though in some cases in the industry's current system it can take more than 5 years."
"WellPoint's investment in its Safety Sentinel System demonstrates the company's commitment to providing the best possible care to its members," said Marcus Wilson, Pharm.D., president of HealthCore. "What differentiates our
system from other safety programs is not only our ability to access massive amounts of data to detect the presence of serious safety issues, but also our ability to work in collaboration with our vast network of health care providers across the country to quickly and effectively evaluate the validity of the signal."
HealthCore, a subsidiary of WellPoint, is a health outcomes research organization that has served the needs of health plans, physician practices and pharmaceutical manufacturers since 1996. HealthCore focuses on providing evidence of the real-world safety and effectiveness of therapeutics; offering insight to best utilize this evidence; and communicating these findings to health care decision-makers. The company's work is increasingly used to support the practice of evidence-based medicine, to advance quality improvement, and to enhance patients' quality of life and satisfaction with care. Today HealthCore has more than 100 clinical projects underway with a number of academic and industry partners.
WellPoint, Inc. is the largest health benefits company in terms of medical membership in the United States. WellPoint is an independent licensee of the Blue Cross Blue Shield Association and serves its members as the Blue Cross licensee for California; the Blue Cross and Blue Shield licensee for Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri (excluding 30 counties in the Kansas City area), Nevada, New Hampshire, New York (as Empire Blue Cross Blue Shield in 10 New York City metropolitan and surrounding counties and as Empire Blue Cross or Empire Blue Cross Blue Shield in selected upstate counties only), Ohio, Virginia (excluding the city of Fairfax, the town of Vienna and the area east of State Route 123.), Wisconsin; and through UniCare. Additional information about WellPoint is available at www.wellpoint.com.
CONTACT: Media, Kristin Binns, +1-917-697-7802, [email protected], or Investor Relations, Michael Kleinman, +1-317-488-6713, both of WellPoint, Inc.
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