The authors of a clinical study of an herbal medication have retracted after it became clear that one of the study authors had included two figures without the consent of his co-investigators.
The paper was a study of Green Cross Corporation of Korea’s SHINBARO, which was approved last year for the treatment of osteoarthritis by the Korean FDA.
The editors of the Archives of Pharmacal Research, where the research found a home, ran this notice:
The Editors of the Archives of Pharmacal Research and the publisher hereby retract the article entitled “SHINBARO, a New Herbal Medicine with Multifunctional Mechanism for Joint Disease: First Therapeutic Application for the Treatment of Osteoarthritis” by Sung-Yeol Lee, Hyoung-Keun Kwon, and Sun-Mee Lee, which appeared in Arch Pharm Res, 2011, Vol. 34, No. 11, pp. 1773-1777, due to copyright issues of clinical data from Phase III trials (Figures 3 and 4).
Here’s how Sang Geon Kim, editor-in-chief of APR and no stranger to retractions, explained what happened:
First of all, we assure you that to our knowledge, the data in Figures 3 and 4 were not published elsewhere before the publication in Archives of Pharmacal Research. The retraction of the indicated article was voluntarily requested by the corresponding author, Sung-Yeol Lee together with other authors. According to the request letter by the authors, the corresponding author did not obtain prior consent to publish the data from other co-investigators. The corresponding author admitted his mistake to overlook the proper procedure for publication. He sincerely wanted to take full responsibility and would like to retract the article to resolve further controversy and conflict. The Pharmaceutical Society of Korea (in the executive members’ meeting) and the Editorial board of Archives of Pharmacal Research examined his article and the request letter, respectively, and also discussed this matter with the managing editor of Springer. According to the comments and suggestions, the Editorial board of Archives of Pharmacal Research decided to respect the corresponding author’s decision and accepted the request for retraction. The explanation was briefly summarized based on our decision and the request letter together with the help of the managing editor of Springer.
We, the Editorial board of Archives of Pharmacal Research, keep trying our best to publish the original and solid scientific data and at the same time to provide beneficial communicating matrix for potential authors. We regret that we had such incidence to retract an article upon the authors’ request. We hope that the answer would satisfy your questions and does not misconvey the authors’ intention.
We reached out to corresponding author Lee, who is also managing director for corporate development for Green Cross Corp., and we’ll update if we hear anything back. In the meantime, here’s the abstract of the now-retracted study:
SHINBARO is a purified extract from a mixture of 6 oriental herbs (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex) that have been used as a traditional medicine for treatment of several inflammatory diseases and bone disorders. We determined antiinflammatory and antinociceptive activities of SHINBARO in adjuvant-induced (osteo)arthritis in rats. This potential anti-(osteo)arthritic property of SHINBARO can be due to the downregulation of inflammatory mediators such as iNOS, COX-2, and TNF-α, the increase of pain threshold in the peripheral system, the activation of alkaline phosphatase in osteoblasts, the suppression of proteoglycan degradation, and the inhibition of MMP-2 and MMP-9 activities as demonstrated by in vitro and in vivo experimental studies. We confirmed that SHINBARO is as effective as celecoxib, a selective COX-2 inhibitor, but it has the better safety profile in clinical trials. Finally, SHINBARO was approved as a New Herbal Medicine for treatment of osteoarthritis by Korean FDA on January 25(th), 2011.
Thank you for this interesting report. I discuss copyright implications in scholarly research with faculty and graduate students. What I find interesting, however, is the explanation “copyright issues of clinical data.” According to both the Copyright Act of 1976 and accompanying regulations at 37 CFR sec. 202, copyright is granted only for fixed works that are “original” (i.e. have some modicum of creativity).
The problem I have with that explanation is that clinical data, in and of itself, usually does not meet the originality test required for copyright protection. Therefore, such data does not qualify for copyright protection.
Further, if the data were contained in some other writing that did qualify for copyright protection, and the author of that writing made the protected work publicly available, then there is a question about whether or not the paper should have been published at all — not necessarily on copyright grounds, but based upon a rationale that the submitted paper did not qualify as original (i.e. formerly unpublished). This assumes, of course, that APR has a policy of publishing only research that has not been published elsewhere, which tends to be the norm among peer reviewed journals in several scientific disciplines.
In short, without more to go on, the stated claim that the publisher pulled the paper because of “copyright issues” sounds fishy. What may be more likely is that one of the scientists used academic work — data that does not qualify for copyright protection — without the permission of collaborators. If so, that is a plagiarism and ethics issue; it does not follow, however, that there is a copyright infringement issue.
Dr. K. Matthew Dames
Copyright & Information Policy Adviser
Syracuse University
I agree with Matthew Dames. The “copyright issues” excuse sounds fishy.
So the corresponding author, who takes responsibility for the “mistake” that prompted the request for retraction, is also the managing director for corporate development of Green Cross, the company that owns this new drug that is the subject of the retracted paper. Good sleuthing, RW. Lee sounds like a courtesy author to me, and the real reason may be related to the company’s expectations for making a profit from the drug.
I don’t see how the real reason could be patent issues, because they had to reveal the composition of the drug to get it accepted under the journal’s requirement for natural extracts. So they don’t want those trial numbers made public for some reason. Hm, wonder what that might be.
Pharmacal Research??
Is this the clearest case of retraction because of copyright infringement in some figures?
I imagine there are many articles published out there that took an image from a website with copyright and without attribution. However I haven´t found any article retracted by this reason.
According to the rules for publishing. To publish an image whose copyright belongs to somebody else is unacceptable, However, in practish, it seems accepted.
Imagine an article that investigates into composite material, and it has a micrograph of carbon fibers taken from the website of a manufacturer in the introduction. The website has a clear copyright statement. I cannot give more details. Would it be retracted?