Drugmakers Likely To Step Up Analysis Of Side Effects

With the recent discovery that some long-available drugs have potentially serious side effects, pharmaceutical company IT managers foresee a growing emphasis on monitoring and analyzing drug-usage data in an effort to spot problems earlier.

Stepped-up efforts to collect and analyze information about commercially available drugs were a common topic of discussion at this week's SAS Users Group International conference in Philadelphia. SAS Institute Inc. sells analysis software used by a number of major pharmaceutical companies in the drug-development process.

Last week, Pfizer Inc. pulled its Bextra painkiller drug off the market amid growing evidence that it increased the risk of heart attacks and strokes. Last September, Merck & Co. pulled its Vioxx painkiller from pharmacists' shelves for the same reason.

Pharmaceutical makers already continue to test drugs, as well as monitor information about consumer usage, after they win approval by the Food and Drug Administration and hit the market. But stepping up surveillance of pharmaceuticals after they hit the market will become a top priority for drugmakers, said Raymond Bain, VP of biostatistics and research decision sciences at Merck Research Laboratories, in an interview with reporters at the conference.

That will require collecting drug-usage data and identifying "safety signals"--indications of unexpected adverse effects--through statistical analysis as quickly as possible, Bain said. Such efforts will require new analysis methodologies, which he said drug companies are now developing, and computer programs to perform the analysis.

"I think that's going to be huge," said Rick Miller, clinical information management director at Solvay Pharmaceuticals Inc., at the conference.

But Miller and Bain said the challenge would be collecting the data from disparate sources and standardizing it for analysis. Unlike data collected under controlled conditions during clinical drug trials, data on actual drug usage and side effects can come from hospital health records, patient health diaries, medical payment claims, and other sources--all in different formats. "The amount of data is immense," Bain said.

Analysis of usage data will be helped by the health-care industry's steps to switch to electronic medical records from paper-based systems, as well as adoption of the Health Level 7 health-care data interchange standard. A panel of pharmaceutical industry executives at the conference discussed a proposed data standard for health diaries kept by patients, called ePRO (electronic patient-reported outcomes), which also could be a source of data for pharmaceutical analysis.