Researchers try web-monitoring to flag side effects early

Forget the FDA's database of adverse events. A group of scientists wants to get out ahead of drug side-effect reports by monitoring online chatter and news.

As The Wall Street Journal reports, researchers have developed algorithms to monitor patients' comments in online chats and on websites, as well as data from news stories, for potentially serious drug reactions. The idea is to identify trends that deserve attention from regulators and healthcare providers--and long before those safety signals might have surfaced under old-style reporting.

Anyone who's been following the drug industry over the past decade or so knows that it can take years for serious side effects to make their way through FDA review and into warnings on drug labels. Even drugs that were subsequently pulled because of safety problems--including the notorious Vioxx--had been marketed for years before then.

Hence this new project for researchers at University of Virginia and West Virginia University, who are tweaking their algorithms by testing them on drugs already flagged with FDA warnings. After churning through Web data from the past decade, the WSJ says, their formulas found patterns of side effects an average of 3 months before FDA issued warnings--but in some cases, were years ahead.

It's the sort of active surveillance that FDA has said it wants to move toward, rather than the passive system used now, which relies on doctors, drugmakers and patients to report any problems themselves. The agency's Sentinel initiative is one step in that direction.

- read the WSJ piece (sub. req.)

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