May 20, 2009 —The Journal of the American Medical Association (JAMA) has retracted an article that it published a year ago on the use of chemoembolization in liver cancer.
The article, by Bao-quan Cheng MD, PhD, from Shandong University in Jinan, China, and colleagues, reported on a randomized trial of 291 patients with large hepatocellular carcinoma tumors (>3 cm). It concluded that treatment with transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation was superior to either technique used alone, and that the combination was a safe and effective treatment that could improve long-term survival.
The article was published April 9, 2008 in JAMA, and was reported by Medscape Oncology at the time, along with comments from Dr. Cheng.
The article received wide attention within the medical community involved in liver transplant, hepatology, and hepatocellular carcinoma, says Alok Khorana, MD, associate professor and vice-chief at the Division of Hematology-Oncology at the James P. Wilmot Cancer Center, University of Rochester in New York. He was commenting in the OncNotes blog he writes for Medscape.
"I know that our group seriously considered switching protocol from TACE alone to TACE plus [radiofrequency ablation] but hadn't quite gotten to making this an official policy," Dr. Khorana wrote. "I'm glad we didn't move on this study, because it was all, apparently, made up."
After publication of the article, JAMA reports that it was contacted by several readers who raised "concerns about the integrity of the data and the veracity of the report." The journal contacted the primary author, Dr. Cheng, but continued to have concerns, and therefore requested a formal investigation by the authors' institution.
The Shandong University School of Medicine replied just recently, sending a formal report in March 2009. Dean Yun Zhang, MD, PhD, explained 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," and these experts "thoroughly investigated the protocol, ethics, medical records, methods, statistics, results, and conclusions."
This investigation concluded that:
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.
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.
The report from Shandong University School of Medicine suggested that, because of these "unscientific behaviors," the article should be withdrawn.
JAMA duly did withdraw the article, explaining that the retraction is based on this report.
But is this enough? The fact that a journal as prestigious as JAMA was hoodwinked in this manner is disconcerting, but the way it has dealt with the matter is "even more disconcerting," Dr. Khorana writes in his blog.
It now appears that the article was "completely fraudulent," but there was "no hint to readers for a full year that the article was under 'internal' investigation," Dr. Khorana notes. During that year, patients may have been treated on the basis of this article, he points out. Also, why is Dr. Cheng getting all the blame, he wonders: Did the coauthors not realize that the study was not approved, and even worse, not randomized?
"There needs to be a mea culpa from JAMA and some more evidence of scientific rigor befitting the pre-eminent internal medicine journal, Dr. Khorana concludes.
JAMA. 2009;301:1931. Abstract
Medscape Medical News © 2009
Cite this: JAMA Retracts Article on Chemoembolization in Liver Cancer - Medscape - May 20, 2009.