News Feature: Strong medicine

In the first week of April, a small group of researchers is quietly meeting in Santa Fe to launch a project that could become an important tool in the bitter battle to ensure drug safety. The group—which includes physicians, statisticians, social scientists and epidemiologists—is developing what many experts argue is badly needed in the US: a virtual data warehouse that would integrate the electronic medical and pharmacy records of nearly 18 million patients in 13 health maintenance organizations (HMOs) across the country. Adverse drug reactions are carefully monitored in clinical trials with select participants before a drug is approved by the US Food and Drug Administration (FDA), but there is virtually no systematic monitoring of a drug’s safety once it hits the market. “[Today] we have a huge number of drugs, the health care system is in crisis in this country to a great extent and the issue is: how do we find out the fate of those drugs when they are actually used out there?” says Janet Woodcock, acting deputy commissioner of the FDA and chief of its Center for Drug Evaluation and Research until last year. Databases like this incipient one may be part of the solution. The information they would provide would be based not just on the static snapshot of effects pinned down at the time of a drug’s approval, but on ongoing surveillance after the drug’s release. The three-year $3.5 million project is being funded by the US National Institutes of Health and run by researchers affiliated with the nationwide HMO Research Network (http://hmoresearchnetwork.org). In the short term, the warehouse will provide a vast resource—with data carefully protected for privacy—that epidemiologists can mine when they suspect a drug of causing an adverse reaction. But the ultimate goal is to provide the raw data for a twenty-first–century system of pharmacovigilance that will reach doctors wherever they work. Ideally, when a physician enters a drug order into an electronic medical record, a couple of clicks of the mouse would reveal any serious side effects. “As a practicing doctor who has seen my patients harmed, as most of us have, by a medication we thought was safe, it would be reassuring to know that there was something out there that could find these side effects reliably and independently,” says Eric Larson, principal investigator on the project and director of the Center for Health Studies at Group Health Cooperative, a Seattle-based HMO.