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

Teschke, Rolf, Eickhoff, Axel·2016·International Journal of Molecular Sciences
DOI 10.3390/ijms17040476PMC PMC4848932
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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.

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Metadata

Authors
Teschke, R., & Eickhoff, A.
Affiliations
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
Venue
International Journal of Molecular Sciences
Publisher
MDPI AG
Published
2016-03-31
Volume
17
Issue
4
Pages
476
ISSN
1422-0067
DOI
10.3390/ijms17040476
PMC
PMC4848932
Cited by
29
References
3
Language
en
Licence
creativecommons.org/licenses/by/4.0/ (vor)

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Teschke, R., & Eickhoff, A. (2016). The Honolulu Liver Disease Cluster at the Medical Center: Its Mysteries and Challenges. International Journal of Molecular Sciences. https://doi.org/10.3390/ijms17040476