Eli Lilly & Company. CEO Sidney Taurel calls on the health care industry, medical community, and US 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.
His proposal, along with other benefits that would flow from a true healthcare Information Revolution, offered no blueprint for creating the system.
"The use of prescription medicines always will be a matter of balancing benefits and risks. Fortunately, systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use," Taurel said in the speech he delivered Tuesday at the Cleveland Clinic Medical Innovation Summit
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 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. The result would be a more accurate picture of a drug's safety and efficacy than exists today.
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 centres, 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. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly," said Taurel.
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. 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. We need to open our minds to the notion that electronic health care data represents a legitimate resource - to which access should in most cases be widespread and easy," added Taurel.