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Caveat Lector: Where's the Safety Information in Medication Trials?

The paucity of safety reporting may someday haunt clinicians and pharmaceutical companies, as evidenced by the current controversy regarding children's use of antidepressant medications.

The discerning consumer of contemporary, "evidence-based," clinical studies must know how to read between the lines. To learn about the adequacy of published safety data, these authors analyzed 142 randomized, controlled, clinical trials randomly selected from specialty registries of the Cochrane Collaboration (depression, anxiety, and neurosis; developmental, psychosocial, and learning problems; dementia and cognitive improvement; schizophrenia; and drug and alcohol abuse).

The authors grouped together the individual references pertaining to each trial and examined all of the reports. Overall, 103 trials (72.5%) involved medication, of which 31 (30.1%) had received government funding. Among medication trials, only 21.4% adequately reported clinical adverse events, and only 16.5% adequately reported laboratory-determined toxicity; only 32.0% reported both the numbers and the reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted one tenth of a page to safety. Long-term trials and those conducted mostly in the U.S. devoted even less space to safety. Trials involving schizophrenia devoted more space in results sections to safety than did trials for other conditions. No psychosocial-treatment study reported adverse events adequately.

Comment: The lack of safety information sorely limits clinicians' abilities to adequately conduct informed-consent discussions with their patients and may come back to haunt clinicians and pharmaceutical companies, as evidenced by the current controversy regarding the use of antidepressant medications in children. The authors advocate for guidelines requiring publication of more safety information in professional journals. Until standardized guidelines are instituted, clinicians need to vigilantly seek safety information from all published and unpublished sources, including colleagues and even competing pharmaceutical representatives.

— Joel Yager, MD

Published in Journal Watch Psychiatry October 6, 2004

Citation(s):

Papanikolaou PN et al. Safety reporting in randomized trials of mental health interventions. Am J Psychiatry 2004 Sep; 161:1692-7.

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