Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm : a randomized controlled trial

IN THE APRIL 9, 2008, ISSUE OF JAMA, AN ARTICLE ENtitled “Chemoembolization Combined With Radiofrequency Ablation for Patients With Hepatocellular Carcinoma Larger Than 3 cm: A Randomized Controlled Trial” was published by Dr Cheng and colleagues. We subsequently received information that raised concerns about the integrity of the data and the veracity of the report. We conducted an extensive internal investigation into these concerns, contacted the primary author of the study, and also notified Shandong University, the authors’ institution, expressing our concerns about the conduct of the trial and the integrity of the data. Based on the responses we received from the authors, we continued to have concerns about the validity and integrity of the study, and therefore requested a formal investigation by the authors’ institution. On March 23, 2009, we received a report from Yun Zhang, MD, PhD, Vice President, Shandong University, and Dean, Shandong University School of Medicine. Dean Yun Zhang indicated that “it took a long time to make a complete investigation” because the university “organized a group of experts in the field of hepatology to investigate the article” by Cheng et al and these experts “thoroughly investigated the protocol, ethics, medical records, methods, statistics, results, and conclusions relevant to this article. ” In addition, this investigative group carefully studied the comments of the JAMA editors and reviewers and previous versions of the manuscript reporting the results of this study. The report by the dean indicates the following: “Based on these investigations, we have drawn the following conclusions: 1. The protocol and ethics of this study were not submitted to the Academic Committee of Shandong University Qilu Hospital for approval. Dr Cheng wrote and submitted this manuscript during his postdoctoral training in Sweden without informing our institution. 2. This study was not a well designed, randomized and controlled clinical trial despite the fact that chemoembolization and radiofrequency ablation for patients with hepatocellular carcinoma have been performed in Shandong University Qilu Hospital for many years. Therefore, conclusions drawn from this study are not valid. 3. Because of these unscientific behaviors, we suggest that the article by Dr Cheng should be withdrawn from JAMA. We apologize for any negative impacts on JAMA caused by publication of this paper. We have submitted a report on this serious issue to the Academic Committee of Shandong University and will keep you informed of further decisions on Cheng’s mistakes from our university. ” Accordingly, based on this report, we hereby retract this article from JAMA and from the medical literature. We appreciate that readers of JAMA brought their concerns about this article to our attention and their patience in allowing us to investigate, and we are grateful to the dean at Shandong University School of Medicine for the thorough and detailed investigation and professional response to our concerns. The cooperation and professional actions of all involved in this inquiry allowed for a complete investigation. This is an example of how maintaining scientific integrity for published articles requires a team effort by readers, journal editors, and the system of academic oversight.