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Abstract
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two decades ago.1 Despite this, we still do not fully understand the effects of these drugs, nor can we be confident about their risk-benefit ratio.
Unresolved problems include the nature and frequency of potential serious adverse effects such as self harming or suicidal actions, suicidal ideation, and aggression. In the linked paper, Sharma and colleagues use clinical study reports to explore such adverse effects.2 Clinical study reports are prepared by pharmaceutical companies for obtaining marketing authorisation. Guidelines on the contents and presentation of clinical study reports exist,3 but requirements are not mandatory. Consequently, although clinical study reports usually contain more data than published articles,4 the level of detail varies. Moreover, what is reported in the body of the clinical study reports may differ from data in appendices, such as individual patient listings of adverse events or narratives of serious adverse events.
The analysis of clinical study reports by Sharma and colleagues reveals misrepresentation of adverse events. Comparing the "results" reported in the reports with data from individual patient listings or patient narratives revealed misclassification of deaths in people taking antidepressants and misrepresentation of suicidal events. More than half of the suicide attempts and instances of suicidal ideation were coded as "emotional lability" or "worsening of depression," for example. Summary reports published on Eli Lilly's website were even more incomplete, listing only 10% of the suicide attempts revealed in the corresponding clinical study reports, and no instances of suicidal ideation.
Over half of the clinical study reports selected by Sharma and colleagues had no individual patient listings, these data having been withheld. This begs the question of how many more adverse events would have been revealed if individual patient listings were available for all trials, and raises concerns about why this information is allowed to be withheld.
Language: en |