A new approach to ensuring drugs are safe
Researchers propose a new empirical method for monitoring and evaluating the safety of drugs already on the market
By Sarah Kuta – In May 2007, the US Food and Drug Administration issued a strict warning for rosiglitazone after studies linked the approved diabetes drug to an increased risk of heart problems. Use of the drug plummeted 78 percent in 15 months; annual sales dropped from $3 billion to $183 million.
In 2013, following additional studies of the drug’s safety, the FDA reversed course and removed restrictions on rosiglitazone. But it was too late to undo the damage caused by their initial warning—sales never recovered, and patients had to resort to taking potentially less suitable medications.
The FDA could have prevented this six-year roller-coaster ride if it had taken a more robust, data-driven approach to its postmarket drug surveillance process, suggests research by Southern Methodist University’s Vishal Ahuja, Texas Tech’s Carlos Alvarez, and Chicago Booth’s John R. Birge and Chad Syverson.
Using rosiglitazone as a retrospective case study, the researchers propose a new empirical method for monitoring and evaluating the safety of drugs already on the market. Their approach uses large, relevant, and reliable longitudinal databases and established econometrics methods to assess the relationships between approved drugs and potentially related adverse health events.
This evaluation method could help prevent incorrect drug recalls and warnings that cause financial consequences for drugmakers, confusion among doctors, and potential harm to patients’ health, the researchers argue. more>
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