Exhibit 089 ยท Record comparison and meta-analysis
Selective publication of antidepressant trials and its influence on apparent efficacy
According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.
Compared FDA reviews of 74 trials of 12 antidepressants (12,564 participants) with the published literature. FDA judged 38 trials positive; 37 were published as positive and one was unpublished. Of 36 trials FDA judged negative or questionable, 22 were unpublished, 11 were published as positive and 3 were published conveying a negative result. Published trials appeared positive in 48 of 51 cases (94%), against 38 of 74 (51%) in FDA review. The 23 unpublished trials enrolled 3,449 participants. Published data inflated the pooled effect size by 32%. The authors could not determine whether sponsors, authors or journals caused the missing publications.
- Source
- Turner et al., New England Journal of Medicine
- Date
- 2008
- Quoted from
- Abstract (PubMed PMID 18199864), Results
- Grade
- Peer-reviewed
- Document
- https://pubmed.ncbi.nlm.nih.gov/18199864/
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- PubMed record: https://pubmed.ncbi.nlm.nih.gov/18199864/.