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CNS Clinical Trials Suicidality and Data Collection: Workshop Summary (2010) / Chapter Skim
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1 Perspectives from the FDA, Academia, and Patients
Pages 7-16

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From page 7...
... Laughren's presentation addressed the methodology and main findings of his division's meta-analysis of proprietary clinical trial data dealing with antidepressants and suicidality. His presentation also covered what Laughren characterized as the FDA's "evolving" policy on a requirement to assess suicidality prospectively in future clinical trials for all new psychiatric drugs.
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From page 8...
... The FDA sought to collect and further analyze additional data beyond what drug sponsors previously submitted to them from clinical trials. The FDA's solicitation covered all psychiatric drugs and all psychiatric indications.
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From page 9...
... However, Gail Griffith, patient representative to the FDA Psychopharmacological Drugs Advisory Committee, felt that the media, practitioners, and the public focused heavily on the risks despite the documented benefits of psychiatric drug treatments, leading to increased suspicion and alarm. There are two main findings of the meta-analysis, according to the data in Laughren's presentation.
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From page 10...
... Similarly, if ascertainment bias was responsible, he asked how the presence of treatment-emergent adverse events could explain the agerelatedness of the finding. Furthermore, how would ascertainment bias explain the other finding that the relationship is stronger in nondepressed psychiatric patients, usually those with anxiety disorders, rather than in depressed patients?
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From page 11...
... She opened her presentation with the observation that psychiatry as a field possesses neither the clarity on how to define suicidal occurrences nor the accompanying terminology, standardization, and training from which clarity would flow. Lack of clarity has tremendous implications because it limits confidence in epidemiological statistics, which can miss signals or amplify false signals.
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From page 12...
... C-CASA provides a common language to classify suicidality data derived from retrospective examination of clinical trials submitted to the FDA (Figure 1-2)
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From page 13...
... Psychiatric professionals are trained on this tool via a web-based DVD and more sophisticated means. It is used by national and international agencies, including the World Health Organization, Japanese National Institute, Centers for Disease Control and Prevention, and other Public Health Service agencies, as well as in primary care and schools and on college campuses, Posner said.
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From page 14...
... prescribing." As the FDA attempted to clarify and make transparent its concern about a possible relationship between antidepressants and suicidality, she believed the anxious public was so suspicious of psychiatry and psychiatric drugs that it was far more inclined to exaggerate the risks and ignore the potential benefits. At that point, she reached the conclusion that the black box warning "constituted a real setback in my mind for treatment and for the field of mental health." In retrospect, Griffith said she regretted her support in 2004 in favor of the initial black box warning, despite the possible link between suicidality and antidepressants.
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From page 15...
... PERSPECTIVES 15 squarely against a black box warning, epilepsy advocates succeeded in convincing the FDA not to proceed with one. Griffith said she believes that "until psychiatric illnesses are treated like physical illnesses, then all the efforts to end distortions and misperceptions about psychiatric medication benefits are for naught."
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Key Terms

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  • adverse events
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  • kelly posner
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