Recommended reading: Controversial Paxil “Study 329” earns expression of concern
In 2001, the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) reported findings from a randomised trial known as “Study 329”, which concluded that the antidepressant Paxil was safe and effective for children.
Since then, Jon Jureidini and others have expressed concerns over the JAACAP’s promoting of harmful drugs for adolescents to a trusting public and requested that the article be retracted. A detailed reanalysis co-authored by Jureidini in 2015 further revealed these incongruencies, reporting that, in actuality, the drug was “ineffective and unsafe” for the age group studied. Jureidini and others have raised awareness of the movement (Restoring Study 329 – Scientific Integrity Through Data Based Medicine), presenting findings including:
| Original Study 329 (2001) | Restoring Study 329(2015) | |
|---|---|---|
| Conclusion | Paxil was effective Paxil was well tolerated |
Paxil was not effective Paxil caused serious side effects, including hostility, insomnia, and akathisia |
| Adverse events | Did not include all | Included all adverse events, including in taper phase |
| Suicidal behaviour | 6 adolescents experienced “emotionally lability” | 13 adolescents became suicidal |
| Implications | Misled doctors into prescribing a drug that is ineffective, unsafe for adolescents | Corrects the record, reveals that the data did not support the conclusion of the original study |
Thankfully, a new step forward has finally taken place, with the JAACAP issuing an expression of concern for the original article.
This action is encouraging. However, questions still remain about the nature of the JAACAP’s new review into the study.
To learn more, visit Controversial Paxil “Study 329” earns expression of concern after critic sues publisher.