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Lilly’s CEO Calls for Reform of US Drug Safety System

Sidney Taurel, chairman and chief utive officer, Eli Lilly and Company, in a speech delivered recently at the Cleveland Clinic’s 2007 Medical Innovations Summit, called on the health care industry, medical community and U.S. government to actively collaborate on a health information technology system that would provide more rapid and useful insights on the effectiveness of medicines while improving drug safety. Although traditional drug trials will continue to test new hypotheses about medicines after they have reached the market, Taurel outlined how a well-functioning health IT system could serve not only to frame hypothesis for the so-called “Phase IV” clinical research, but also become the practical equivalent of massive, real-world trials. Such a system would collect detailed data from day-to-day medical practices and feed insights quickly, seamlessly and at a lower cost to doctors, regulators, and drug manufacturers. Taurel also explained that the intent of the newly enacted FDA Amendments Act of 2007 is to promote a much wider involvement of health plans, academic medical centers and other sponsors in Phase IV research. Taurel noted that to fully realize a better drug safety system would require the large-scale implementation of Electronic Medical Records (EMRs) – patient-specific repositories of clinical information on diagnoses, treatments, and outcomes. Properly “blinded” to protect patient privacy, EMRs ultimately could include genetic information as well, in order to tailor therapies to patient groups in which they work best. He traced some of the obstacles to implementing robust, secure EMRs, and offered solutions. Taurel explained that as EMR systems build out, they provide what amounts to a ‘commons’ in which organizations can collaborate to share health information. For example, Lilly, Pfizer, and Johnson & Johnson are collaborating with ‘e-Health Initiative’ – a not-for-profit health information technology group – as well as with the Indiana Health Information Exchange and the Partners Healthcare System in Boston. The goal is to test how safety signals can be located and understood using existing data, potentially leading to a better understanding of the risk and benefits of medicines. In conclusion Taurel added that this sort of public-private experiment, along with national standards and regional expansion, will soon create a mass of basic infrastructure that could produce the sort of knowledge that will truly revolutionize patient care.

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