Study 329 was finally published in the July 2001, Journal of the American Academy of Child and Adolescent Psychiatry, with Dr Keller's name as the lead author, but his actual input was seriously questioned by Panorama. In one memo presented in the broadcast, Dr Keller thanked a ghost writer from a PR firm hired by Glaxo for preparing the manuscript stating: "You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me..."
Ms Jofre also read a letter from the ghost writer to Dr Keller, which informed him that all of the necessary materials were enclosed to enable Dr Keller to send the study to a journal for publication. The packet even included a cover letter to submit to the journal with instructions to Dr Keller stating: "please re-type on your letterhead. Revise if you wish."
Ms Jofre also demonstrated that it was clear that the PR woman was making crucial decisions about how to present the data from the study, by quoting one Glaxo executive as saying in a company document: "She's going too far in burying bad news."
"It seems incongruous that we state it as safe yet report so many serious adverse events," another internal Glaxo email dated July 19, 1999 states.
According to Panorama, there were actually 11 side-effects identified in the study including aggression, self-harm, and suicidal thoughts, but yet the final ghost written article read: "Of the 11 patients only headache (one patient) was considered to be related to the treatment," and concludes that Seroxat is "generally well tolerated and effective."
During the program, Ms Menzies told the audience: "They didn't tell the regulators or the physicians or parents about these risks or the lack of efficacy, instead they went out and promoted this specific study as remarkably effective and safe for kids."
"This was a drug that doctors were told could help prevent suicide," Ms Jofre pointed out, "when in reality it was actually making some children suicidal, a triumph of marketing over science."
Since Study 329, (Keller et al 2001), was published, it has drawn criticism from medical professionals around the world. One letter to the Editor by Professors, Dr Jon Jureidini and Dr Anne Tonkin, from Adelaide, Australia, stated: "We believe that the Keller et al. study shows evidence of distorted and unbalanced reporting that seems to have evaded the scrutiny of your editorial process."
"Given that the research was paid for by Glaxo-Smith-Klein," it reads, "it is tempting to explain the mode of reporting as an attempt to show the drug in the most favorable light."
"Given the frequency with which it is cited in other scientific papers, at conferences and educational functions, and in advertising," the letter notes, "this article may have contributed to the increased prescribing of SSRI medication to children and adolescents."
"We believe it is a matter of importance to public health," the letter concludes, "that you acknowledge the failings of this article, so that its findings can be more realistically appraised in decision-making about the use of SSRIs in children."
Another highly critical editorial was published on June 12, 2004, in The Lancet, which stated in part that Glaxo "appears to be floundering in the semantic depths. While it has been earnestly parsing the meaning of 'suicidal thinking and acts' and 'publicly,' it appears to have forgotten what lies behind those words-people."
To further ensure its ability to control negative information, Glaxo made investigators sign agreements not to disclose the study results without the company's OK. "Those researchers, including myself, who did see results of negative paroxetine industry trials were prohibited by nondisclosure contracts from discussing them," says Dr Jane Garland, Clinical Professor of Psychiatry, at the University of British Columbia, "Facing the evidence: antidepressant in children and adolescents," in the February 17, 2004, Canadian Medical Association Journal. In the adolescent paroxetine trials she notes:
10.5% of patients discontinued paroxetine because of "serious" psychiatric adverse effects, of which the most common was euphemistically described as "emotional lability," further defined as "suicidal ideation/gestures; conduct problems or hostility, e.g., aggressiveness....
"Such responses," Dr Garland states, "led 7.5% of the outpatient participants prescribed paroxetine who initially were only mildly depressed to be admitted to hospital, while none of the placebo group required hospital admission."
"The authors dismissed this result," she says, "by stating that these psychiatric adverse effects were not attributed to the medication - despite the fact that numerous reports of agitation and suicidal behaviour in young people treated with SSRIs have accumulated since the 1990s."
