3.1 Authorship

The CIT-MD-18 protocol was written under the signature of Paul Tiseo (Associate Medical Director); he was listed as a co-author on draft #2 of the ghostwritten CIT-MD-18 manuscript along with the three Forest-designated academic authors, however his name disappeared from the author byline on subsequent manuscript drafts [13]. Behind the scenes, Forest emails showed that the manuscript was ghostwritten by Natasha Mitchner at Weber Shandwick Communications, under instruction from Jeffrey Lawrence (Product Manager Forest Marketing). Mary Prescott of Weber Shandwick makes it explicit in her October 15, 2001 email that the manuscript would be written before the academic “authors” were chosen [14] (see Fig. 1).

Control over content and management of the article resided with the marketing department at Forest. Dr. Heydorn (Forest Senior Study Director) wrote to Mr. Lawrence on October 15, 2001: “Given what I have seen of the data, I believe that we should maintain control, which means either writing in house or having an outside group (like Weber Shandwick [BSMG] or a CRO) draft the manuscript” [15]. The ghostwriter, Ms. Mitchner, wrote on December 17, 2001: “I am happy to finish the references and finalize the manuscript. However, can you make sure that I have John MacPhee’s [Forest Group Product Director] permission to do so?” [16]. The clear marketing agenda was apparent when Mr. Lawrence wrote: “As you know, we don’t want to compromise the publication but we would like to wrap some PR [public relations] and CME [continuing medical education] around this data” [14]. Ms Prescott responded with suggestions for how the presentation of the data at a scientific meeting could be used to promote the drug without jeopardizing subsequent publication in an academic journal (see Fig. 1).

The lead author, Dr. Karen Wagner (currently president elect of the American Academy of Child and Adolescent Psychiatry) operated one site of this multi-site trial. Although she advised Forest about journal placement and marketing strategy [17], we could find no evidence in the extensive documents that we reviewed that Dr. Wagner contributed to the study design, analysis of data, or preparation of the first draft of the manuscript. Drs. Adelaide Robb and Robert Findling made only very minor suggestions to one of the late drafts of the manuscript.

Dr. Wagner’s input was sought only after the first draft of the CIT-MD-18 manuscript was prepared and reviewed by Forest Research Institute employees. This is made clear in an email dated December 17, 2001 when Mr. Lawrence wrote to Ms. Mitchner: “Could you do me a favor and finish up the pediatric manuscript? I know you said you only had a bit more to do... I took a quick look at it and it looked good so I’d like to get it circulated around here before we send if off to Karen [Wagner]” [16]. On December 20, 2001, Ms. Mitchner provided Mr. Lawrence with an initial draft of the ghostwritten manuscript. She wrote: “Attached please find the completed draft of the Wagner manuscript” [16].

Fulfilling requirements for the manuscript’s authorship did not appear to be treated with gravity. Ms. Prescott writes: “I don’t know that any decision has been made about who is going to write the manuscript (not to be confused with who is going to be the author[s] of the manuscript, which also isn’t decided, as far as I know)” (Fig. 1).

It seems that ghostwriting of scientific manuscripts was ordinary practice for Forest. A 2004 Marketing Plan for Lexapro ® (released by the United States Senate Committee on Finance investigation) stated that Forest would “fold Lexapro messages into articles on depression, anxiety and co-morbidity developed by (or ghostwritten for) thought leaders” [18]. A similar publication plan had already been in place for Celexa ® [11].

After the publication of the Wagner et al. article the editors of the American Journal of Psychiatry publicly disclosed that the manuscript had been written by a commercial medical writer on behalf of Forest [19]. Despite this unprecedented revelation, the CIT-MD-18 academic authors claimed that they were unaware that Forest retained a commercial writer [20]. However, a string of emails from September 20 to October 31, 2001 established contact between the ghostwriter, Natasha Mitchner, and Dr. Wagner, and revealed Dr. Wagner’s involvement with Forest employees in the selection of the journal on the basis of ‘corporate objectives’ [17].

Even though the results of a prior European citalopram pediatric registration trial (i.e., Lundbeck study 94404) were not published until 2006 [21], as early as July 16, 2001, Forest was aware that the Lundbeck study had failed to demonstrate efficacy for citalopram in adolescents [22]. However, Wagner et al. omitted this fact in their published article, leading the editors of the American Journal of Psychiatry to publish a correction, acknowledging that Forest had failed to disclose the result that the Lundbeck trial was negative and had shown an increase in suicidality in both children and adolescents [19].