Uni dings schizophrenia studies for problems with informed consent, other flaws

Psychiatry journals have retracted two papers evaluating a schizophrenia drug after a university in Japan flagged issues, such as a lack of written informed consent.

The papers—published in Human Psychopharmacology: Clinical & Experimental in 2012 and Psychiatry and Clinical Neurosciences in 2014—examined the safety and effectiveness of an antipsychotic drug in patients with schizophrenia.

According to the retraction notice in Psychiatry and Clinical Neurosciences, the ethics committee at St. Marianna University School of Medicine in Kawasaki found that “the trial included subjects who did not satisfy inclusion criteria.” For instance, not all patients provided written informed consent. But the university found no evidence for data falsification or fabrication.

A spokesperson for Human Psychopharmacology told us:

The retraction was requested by the lead author of the paper whereby he directed us to the findings of the university’s ethical committee that stated that the paper in question had some scientific flaws and protocol deviations. I consulted the journal’s editor-in-chief and he agreed that the retraction was appropriate in light of the findings.

We have limited details about the investigation beyond what’s included in the retraction notices. We obtained a copy of an investigation report from St. Marianna University School of Medicine, but it is in Japanese. (If any readers could help with the translation, email us at retractionwatchteam@gmail.com.)

Here’s the retraction notice, published on earlier this month, for “Long-term efficacy and safety of blonanserin in patients with first-episode schizophrenia: A 1-year open-label trial:”

The above article from Psychiatry and Clinical Neurosciences, first published on 6 July 2014 in Wiley Online Library (www.onlinelibrary.wiley.com), and in Volume 68, Issue 12 pp. 841–849, has been retracted by agreement between the authors, the Editors-in-Chief, Shigenobu Kanba and Tadafumi Kato, and John Wiley & Sons Australia Ltd. The retraction has been agreed following a report from the Investigation Committee of Clinical Trials carried out at St. Marianna University School of Medicine which established that the trial included subjects who did not satisfy inclusion criteria due to a number of factors, including lack of written informed consent. At the same time, the Committee verified that there was no falsification, fabrication or other infringement associated with the paper.

The 2014 paper has been cited five times, according to Clarivate Analytics’ Web of Science.

Here’s the retraction notice for “Effect of blonanserin on cognitive function in antipsychotic-naïve first-episode schizophrenia”:

The above article from Human Psychopharmacology, first published on 25 January 2012 in Wiley OnlineLibrary (onlinelibrary.wiley.com), and in Volume 90, pp. 90-100, has been retracted by agreement between the authors, the journal Editor in Chief, David Baldwin, and John Wiley & Sons Ltd. The retraction has been agreed following an investigation by the St Marianna University Ethics Committee which determined that the paper was not as originally designed and approved.

The 2012 paper, which was retracted in May 2017, has been cited 11 times.

The two papers have six authors in common. We contacted the corresponding author on each paper—Yuriko Ninomiya and Tomomi Tenjin, both based at St. Marianna University School of Medicine— as well as the second author on both papers, Seiya Miyamoto, also based at the university. Our email to Tenjin bounced back.  

Hat tip: Rolf Degen

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