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Lilly's CEO Calls for Reform of Nation's Drug Safety System
Date:10/2/2007

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Taurel also explained that intent of the newly enacted FDA Amendments Act of 2007 is to promote much wider involvement of health plans, academic medical centers and other sponsors in Phase IV research.

"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system," said Taurel. "Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly."

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.

"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," concluded Taurel. "We need to open our minds to the notion that electronic health care data represents a legitimate resource - to whic
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SOURCE Eli Lilly and Company
Copyright©2007 PR Newswire.
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