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Int. J. Mol. Sci. 2016, 17(4), 476; doi:10.3390/ijms17040476

The Honolulu Liver Disease Cluster at the Medical Center: Its Mysteries and Challenges

Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/Main, Leimenstrasse 20, D-63450 Hanau, Germany
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Academic Editor: Johannes Haybaeck
Received: 14 February 2016 / Revised: 18 March 2016 / Accepted: 21 March 2016 / Published: 31 March 2016
(This article belongs to the Special Issue Drug, Herb, and Dietary Supplement Hepatotoxicity)
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Abstract

In 2013, physicians at the Honolulu Queen’s Medical Center (QMC) noticed that seven liver disease patients reported the use of OxyELITE Pro (OEP), a widely consumed dietary supplement (DS). Assuming a temporal association between OEP use and disease, they argued that OEP was the cause of this mysterious cluster. Subsequent reexamination, however, has revealed that this QMC cohort is heterogeneous and not a cluster with a single agent causing a single disease. It is heterogeneous because patients used multiple DS’s and drugs and because patients appeared to have suffered from multiple liver diseases: liver cirrhosis, liver failure by acetaminophen, hepatotoxicity by non-steroidal antiinflammatory drugs (NSAIDs), resolving acute viral hepatitis by hepatitis B virus (HBV), herpes simplex virus (HSV), and varicella zoster virus (VZV), and suspected hepatitis E virus (HEV). Failing to exclude these confounders and to consider more viable diagnoses, the QMC physicians may have missed specific treatment options in some of their patients. The QMC physicians unjustifiably upgraded their Roussel Uclaf Causality Assessment Method (RUCAM) causality scores so that all patients would appear to be “probable” for OEP. However, subsequent RUCAM reassessments by our group demonstrated a lack of causality for OEP in the evaluated QMC cases. The QMC’s questionable approaches explain the extraordinary accumulation of suspected OEP cases at the QMC in Hawaii as single place, whereas similar cohorts were not published by any larger US liver center, substantiating that the problem is with the QMC. In this review article, we present and discuss new case data and critically evaluate upcoming developments of problematic regulatory assessments by the US Centers for Disease Control and Prevention (CDC), the Hawaii Department of Health (HDOH), and the Food and Drug Administration (FDA), as based on invalid QMC conclusions, clarifying now also basic facts and facilitating constructive discussions. View Full-Text
Keywords: Centers for Disease Control and Prevention; Food and Drug Administration; Hawaii Department of Health; Honolulu Queen’s Medical Center; OxyELITE Pro; acetaminophen Centers for Disease Control and Prevention; Food and Drug Administration; Hawaii Department of Health; Honolulu Queen’s Medical Center; OxyELITE Pro; acetaminophen
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Teschke, R.; Eickhoff, A. The Honolulu Liver Disease Cluster at the Medical Center: Its Mysteries and Challenges. Int. J. Mol. Sci. 2016, 17, 476.

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