Restoring Study 329: Letter to BMJ

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When we set out to restore GSK’s misreported Study 329 of paroxetine for adolescent depression under the RIAT initiative, we had no idea of the magnitude of the task we were undertaking. After almost a year, we were relieved to finally complete a draft and submit it to the BMJ, who had earlier indicated an interest in publishing our restoration. But that was the beginning of another year of peer review that we believed went beyond enhancing our paper and became rather an interrogation of our honesty and integrity. Frankly, we were offended that our work was subject to such checks when papers submitted by pharmaceutical companies with fraud convictions are not.

Antidepressants, Pregnancy, and Autism: Why Wouldn’t Antidepressant Chemicals Affect a Developing Baby’s Brain?

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This week another study was published showing that SSRI antidepressant use during pregnancy is associated with increased rates of autism in the children.  By my count, this is now the tenth study on this topic and it follows on the heels of previous studies – all of which found links between SSRI antidepressant use in pregnancy and autism in the offspring.  Most of these studies were recently reviewed by Man, et al, who also concluded that SSRI antidepressant use during pregnancy is associated with autism in the children. So we now have numerous studies in different human populations all showing a link between SSRI use in pregnancy and autism in the children. Yet, much of the news and blogosphere focus on casting doubts about these findings. What is going on here?

Taking Antidepressants During Pregnancy May Lead to Fetal Brain Changes

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The changes caused by prenatal exposure to SSRIs, therefore, might contribute to changes in a developing baby’s sensitivity to serotonin and ability to respond to the brain chemical. Further studies will likely investigate that possibility.