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The LiverTox Paradox-Gaps between Promised Data and Reality Check
Rolf Teschke1,2, Gaby Danan3
1Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, D-63450 Hanau, Germany.
Diagnostics (Basel, Switzerland)
|October 23, 2021
Summary
The LiverTox database aims to identify drug-induced liver injury (DILI) but lacks robust causality assessment. Improvements are needed for reliable DILI case data and identification.
Area of Science:
- Hepatology
- Pharmacovigilance
- Drug Safety
Background:
- The LiverTox database was established to identify hepatotoxicants and provide information on idiosyncratic drug-induced liver injury (iDILI).
- Its current methodology relies on case selection based on publication numbers rather than rigorous causality assessment.
Purpose of the Study:
- To evaluate if LiverTox has achieved its stated aims by comparing current iDILI data with its 2012 promises.
- To analyze the robustness of LiverTox's iDILI likelihood categories and the quality of case data for 46 selected drugs.
Main Methods:
- Analysis of LiverTox's iDILI likelihood criteria for robustness.
- Quality assessment of iDILI cases in LiverTox for 46 drugs.
- Comparison of current LiverTox data with its 2012 objectives.
Main Results:
- LiverTox includes iDILI cases of insufficient quality, lacking standard liver injury definitions and complete, accurate narratives.
- Causality assessment was not performed using the Roussel Uclaf Causality Assessment Method (RUCAM) as promised.
- Causality was instead based on the number of published iDILI cases per drug, compromising data reliability.
Conclusions:
- LiverTox is a valuable resource, but significant methodological weaknesses hinder its reliability.
- Substantial improvements are required, including standardized iDILI case definitions and RUCAM evaluation for robust causality grading.
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