The article “A Randomized, Placebo-Controlled Trial of Citalopram for the Treatment of Major Depression in Children and Adolescents,” published in the June 2004 issue of The American Journal of Psychiatry (vol. 161, pp 1079-1083) is alleged by the United States Department of Justice in an ongoing suit to have been written and submitted to the Journal by a commercial medical writer on behalf of Forest Laboratories, Inc.
We requested responses from Drs. Karen Dineen Wagner, Adelaide S. Robb, and Robert L. Findling (authors in their role as investigators in the clinical trial at their respective universities), Dr. William E. Heydorn (the senior Forest Laboratories study director), and Forest Laboratories. Drs. Wagner, Robb, and Findling reported that they had received an initial draft from Dr. Heydorn to which they contributed through several drafts. The paper was submitted as a Brief Report, which the Journal’s editors requested be resubmitted as a full-length Article. Drs. Wagner, Robb, and Findling report that they contributed with Dr. Heydorn to the resubmission and that they were not aware that Dr. Heydorn was working with a commercial writer. Dr. Heydorn did not respond to our request for comment.
A Forest Laboratory official in a letter of April 17, 2009, acknowledged that: “Forest retained a medical communications company to assist with preparation of the manuscript, a practice we understand to be common among pharmaceutical companies. Following discussion with the article’s named authors, the medical communications company created an initial draft of the manuscript. Over the course of time, however, from the initial draft to the final publication, the manuscript went through multiple iterations with the input of the named authors, as well as others who reviewed and commented on the manuscript; throughout this process, the medical communications company continued to provide copy editing, formatting, referencing and other editorial support. The manuscript was then submitted to AJP by Dr. Wagner, who, along with the other named authors, maintained control over the final content of the manuscript.”
We are satisfied that the named contributors of this article satisfy the criteria for authorship as set forth in the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” from the International Committee of Medical Journal Editors. However, the Journal’s Instructions to the Authors in 2004 and our policy today do not allow contributions by unnamed writers to the preparation of a paper. Thus, the editorial contributions of Prescott Medical Communications Group should have been acknowledged in the published article as required at the time the article was published.
Furthermore, Forest Laboratories failed to disclose to the Journal that it was aware of data from a study by Lundbeck that showed increased suicidality in children and adolescents who were treated with citalopram. Authors and sponsors are expected to disclose the existence of all data that affects the interpretation of their study. This note will appear in Medline and other databases as a Comment on the paper.
The official complaint (United States and Christopher R. Gobble v. Forest Laboratories Inc. and Forest Pharmaceuticals Inc. Civil Action No. 03-10395-NMG) is posted at <online.wsj.com/public/resources/documents/lexapro.pdf>.