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On the Trail of Drug Risks

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ILLUSTRATION BY MATT DORFMAN

The FDA’s current tool for keeping tabs on approved drugs is MedWatch, a system for reporting safety issues with drugs and other medical products. A crucial part of that effort is the FDA Adverse Event Reporting System, or FAERS. A computer database developed in 1998, FAERS includes more than six million reports of adverse drug reactions and medication errors. Health care professionals and consumers can file complaints through the MedWatch Website or by e-mail, phone, fax or letter. In addition, pharmaceutical companies typically have 15 days to report serious side effects. That information from drugmakers accounts for about 80% of the most serious complaints.

Though a gold mine of information, FAERS has many limitations. It can provide raw data, but the database can’t be readily queried. And FDA criteria for what constitutes a “reportable” adverse event are insufficient to determine whether a fever, a rash, dizziness, a seizure or other problem was a true side effect of a drug, a result of combining it with other medications or something that arose because of another factor.

Still, pharmaceutical companies regularly monitor FAERS data, and the nonprofit Institute for Safe Medication Practices publishes Quarter Watch, an electronic newsletter that identifies serious trends it has discovered when analyzing FAERS reports. The FDA also posts on its Website a list of all drugs it has flagged to evaluate for potential safety issues.

Epidemiologist John Brownstein, an associate professor at Harvard Medical School, and his team are working with the FDA to streamline the cumbersome reporting interface on the MedWatch Website, which he says often deters patients and physicians from passing along complaints. The research group is also developing data-mining tools that can look past duplications, spelling errors and other problems that make it difficult to analyze FAERS data. The goal is to detect early signals of trouble with a particular drug and correlate those with demographic information, so that the MedWatch site could include descriptions of a drug’s side effects based on personal characteristics such as age and gender. “We want you to be able to see what adverse effects a drug may have for a person like you,” says Nabarun Dasgupta, a pharmacoepidemiologist and co-founder of Epidemico, a health data analytics company based in Chapel Hill, N.C., and Boston.

Brownstein hopes that MedWatcher, a mobile application launched in 2010, will make it much easier for patients and physicians to report problems. He developed the app in collaboration with the University of North Carolina and says it should take less than three minutes for a user to enter key variables about side effects from any of more than 10,000 medications. “We need to get people more actively engaged in drug safety and reporting an event,” Brownstein says. That includes not only people taking a drug but also, say, a physician who has just seen a patient and heard about a problem. So far, more than 30,000 people have downloaded the app.

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1. “Novel Data-Mining Methodologies for Adverse Drug Event Discovery and Analysis,” by Rave Harpaz et al. Clinical Pharmacology & Therapeutics, June 2012. A leading researcher in biomedical informatics and colleagues discuss the potential and challenges of developing data mining tools and using diverse data sources.

2. “The U.S. Food and Drug Administration’s Mini-Sentinel Program: Status and Direction,” by Richard Platt et al. Pharmacoepidemiology and Drug Safety, January 2012. A report on the FDA’s drug surveillance pilot, using electronic health records of 100 million people, by the lead investigator at the Harvard Pilgrim Health Care Institute.

3. “Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998–2005”, by Thomas Moore et al., JAMA Internal Medicine, Sept. 10, 2007. The first analysis using the FDA’s adverse event reporting database uncovered a number of disturbing trends during the time period, including a nearly threefold increase in reported serious injuries, disability and death associated with drug therapy, suggesting inadequacies in the existing surveillance system.

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