Of ORIGINAL ARTICLE
ilepology January-February, Vol. 15 No. 1, 2016: 91-118
The Official Journal of the Mexican Association of Hepatology,
the Latin-American Association for Study of the Liver and
the Canadian Association for the Study of the Liver
The mystery of the
Hawaii liver disease cluster in summer 2013:
A pragmatic and clinical approach to solve the problem
Rolf Teschke,* Alexander Schwarzenboeck, Christian Frenzel,
Johannes Schulze,— Axel Eickhoff,* Albrecht Wolff****
* Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty,
Goethe University Frankfurt/ Main, Germany.
** Department of Medicine I, University Medical Center Hamburg Eppendorf, Germany.
*** Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.
"**" Department of Internal Medicine II, Division of Gastroenterology, Hepatology and Infectious Diseases, Friedrich Schiller University Jena, Germany.
ABSTRACT
Background and aim. In the fall of 2013, the US Centers for Disease Control and Prevention (CDC) published a preliminary re-
port on a cluster of liver disease cases that emerged in Hawaii in the summer 2013. This report claimed a temporal association as
sufficient evidence that OxyELITE Pro (OEP), a dietary supplement (DS) mainly for weight loss, was the cause of this mysterio-
us cluster. However, the presented data were inconsistent and required a thorough reanalysis. Material and methods. To further
investigate the cause(s) of this cluster, we critically evaluated redacted raw clinical data of the cluster patients, as the CDC re-
port received tremendous publicity in local and nationwide newspapers and television. This attention put regulators and physicians
from the medical center in Honolulu that reported the cluster, under enormous pressure to succeed, risking biased evaluations and
hasty conclusions. Results. We noted pervasive bias in the documentation, conclusions, and public statements, also poor quality
of case management. Among the cases we reviewed, many causes unrelated to any DS were evident, including decompensated
liver cirrhosis, acute liver failure by acetaminophen overdose, acute cholecystitis with gallstones, resolving acute hepatitis B, acute
HSV and VZV hepatitis, hepatitis E suspected after consumption of wild hog meat, and hepatotoxicity by acetaminophen or ibupro-
fen. Causality assessments based on the updated CIOMS scale confirmed the lack of evidence for any DS including OEP as culprit
for the cluster. Conclusions. Thus, the Hawaii liver disease cluster is now best explained by various liver diseases rather than
any DS, including OEP.
Key words. Centers for Disease Control and Prevention. Food and Drug Administration. Hawaii Department of Health. Honolulu
Queen's Medical Center. OxyELITE Pro.
INTRODUCTION ment of Health (HDOH), with the CDC and the US
Food and Drug Administration (FDA), had initiated a
A 2014 article in the New EnglandJournal of Medicine pro- public health investigation.2
voked interest and controversy when it reported that epi- Patients of this Hawaii cluster mostly became ill in the
demiologists at the US Centers for Disease Control and summer of 2013 - highly suggestive of a seasonal outbreak
Prevention (CDC) had confirmed what a liver-transplant by zoonical, bacterial, or viral pathogens like hepatitis A
surgeon in Honolulu had suspected: OxyELITE Pro virus (HAV) or hepatitis E virus (HEV);3 such geographic
(OEP), a popular over-the-counter dietary supplement clusters are rarely caused by DS or drugs with national
(DS) for weight loss, was responsible for a cluster of cases distribution. HEV genotypes 1-4 occur in humans, types 3
of severe hepatitis and acute liver failure (ALF) in the and 4 in animals.4-6 Infected animals may transmit HEV in-
summer of 2013.1 OEP had been withdrawn from the fections to humans,4-12 with farmers, hunters, and outdoor
shelves,1 and in September of 2013, the Hawaii Depart- enthusiasts at high risk of contracting HEV from infected
Manuscript received: March 16, 2015. Manuscript accepted: May 16, 2015.
DOI: 10.5604/16652681.1184237
Good enough?