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01.02.2012 | Commentary | Ausgabe 1/2012

Critical Care 1/2012

Drotrecogin alfa (activated) ... a sad final fizzle to a roller-coaster party

Zeitschrift:
Critical Care > Ausgabe 1/2012
Autor:
Derek C Angus
Wichtige Hinweise

Competing interests

The author declares that he was principal investigator on grants received by the University of Pittsburgh from Eli Lilly and Company for the conduct of the long-term follow-up and cost-effectiveness studies accompanying PROWESS. He also received consulting fees and speaking honoraria from Eli Lilly and Company between 1996 and 2004. He received compensation from Eli Lilly and Company for serving on the Data Safety and Monitoring Board for PROWESS-SHOCK. He has also received consulting fees from Eisai Inc. (Woodcliff Lake, NJ, USA) and Idaho Technology Inc. (Salt Lake City, UT, USA), which are also engaged in sepsis research.

Abstract

Following the failure of PROWESS-SHOCK to demonstrate efficacy, Eli Lilly and Company withdrew drotrecogin alfa (activated) from the worldwide market. Drotrecogin was initially approved after the original trial, PROWESS, was stopped early for overwhelming efficacy. These events prompt consideration of both the initial approval decision and the later decision to withdraw. It is regrettable that the initial decision was made largely on a single trial that was stopped early. However, the decision to approve was within the bounds of normal regulatory practice and was made by many approval bodies around the world.Furthermore, the overall withdrawal rate of approved drugs remains very low. The decision to withdraw was a voluntary decision by Eli Lilly and Company and likely reflected key business considerations. Drotrecogin does have important biologic effects, and it is probable that we do not know how best to select patients who would benefit. Overall, there may still be a small advantage to drotrecogin alfa, even used non-selectively, but the costs of determining such an effect with adequate certainty are likely prohibitive, and the point is now moot. In the future, we should consider ways to make clinical trials easier and quicker so that more information can be available in a timely manner when considering regulatory approval. At the same time, more sophisticated selection of patients seems key if we are to most wisely test agents designed to manipulate the septic host response.

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