All clinical trials must be reported in detail and made publicly available

Editor—It is usually only the regulatory agencies, such as the Food and Drug Administration, that have access to clinical trials data submitted from pharmaceutical companies, as described by Lenzer for selective serotonin reuptake inhibitors in children.¹ However, the situation is now different for paroxetine. Full reports of its clinical trials are available on the internet,² and we can critically examine their data on childhood depression. Three unmistakable facts emerge.

Firstly, what the company calls “emotional lability” is none other than “suicidal tendencies.” The reports did not label the symptoms “emotional lability” unless there was suicidality.

Secondly, two cases of suicidal tendencies were not counted towards “emotional lability.” A 14 year old boy who “punched pictures, broke glass, and sustained lacerations that required six sutures,” “expressed hopelessness and possible suicide thoughts,” and “was hospitalized” was treated as a case of aggression but not of emotional lability. Another 11 year old boy who “threatened to harm himself and was hospitalized with an acute exacerbation” was counted as a case of exacerbated depression but not of emotional lability.

Thirdly, taking all these cases into account, the pooled odds ratio for suicidality with paroxetine was 2.77 (fixed effect model 95% confidence interval 1.03 to 7.41). No heterogeneity was present (figure).

Figure 1.

Suicidal tendencies in paroxetine trials with children and adolescents

There is one clear lesson to be learnt. All clinical trials, not only those conducted by drug companies but all of them, must be reported in detail and made publicly available as soon as reasonably possible. Without such policy internationally, neither healthcare professionals nor consumers can make sufficiently informed decisions.