The authors of Study 329 began recruiting adolescents for a comparative study of Paxil, imipramine and placebo in 1994 and finished their investigations in 1997. They dropped a large number of their original cohort, so the randomness element in the study must be open to question. Late in 1998, SmithKline Beecham, the marketers of Paxil, acknowledged in an internal document that the study had shown that Paxil didn’t work for adolescents in terms of the two primary and six secondary outcomes they had established at the start of the study. In a nutshell, Study 329 was negative for efficacy and positive for harm, contrary to their succinct upbeat conclusion.
New research published in the August issue of Psychiatric Annals evaluates the results of randomized control trials on the use of various psychotropic drugs for patients diagnosed with borderline personality disorder (BPD). Despite the “American Psychiatric Association’s practice guidelines endorsement of SSRIs as first-line therapies for BPD,” the results of the meta-analysis reveal that pharmacotherapy in BPD is “not supported by the current literature,” and “should be avoided whenever possible.”
In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.
My prior MIA blog posts have largely addressed the problems that can occur when people try to stop taking serotonin-related antidepressants, particularly after taking them for a long period of time. I wanted to share a few updated thoughts that I have on the problem.
The impact of long-term SSRIs on memory-related nerve cell receptors does have functional consequences. Research shows that SSRIs impair the acquisition of fear memories. (Perhaps a positive outcome.) But unlearning fear memories involves new learning as well, and according to a study by LeDoux and colleagues, long-term exposure to SSRIs makes it harder to unlearn fear memories.
I do not understand how we can continue to avoid the conversation about psychiatric medications and their role in the violence that is affecting far too many of our children, whether Seung-Hui Cho, Eric Harris, Kip Kinkel, or Jeff Weise (all of whom were either taking or withdrawing from psychotropic medications) or the scores of children and adults they have killed and harmed. It is not clear what role medications played in the Newtown tragedy, though news reports are now suggesting there is one.
The conventional wisdom is that antidepressant medications are effective and safe. However, the scientific literature shows that the conventional wisdom is flawed. While all prescription medications have side effects, antidepressant medications appear to do more harm than good as treatments for depression.
For the past several years whenever a critical essay has come along examining the work of Irving Kirsch and his colleagues I have made an effort to examine the validity of the proposed arguments. Kirsch and his colleagues used the Freedom of Information Act to gain access to the unpublished trials of antidepressants and then pooled the clinical trial data – both published and unpublished ─ and analyzed it as a single data set. It is common for pharmaceutical companies to only publish those studies that find their products effective, and to withhold the negative studies, making it difficult to reach accurate conclusions by examining only the published data. Kirsch and his colleagues have reported that in the company sponsored clinical trials, the SSRIs only marginally outperform placebo, with the difference being statistically different but not clinically significant.
The Atlantic web site has just published a strange piece on the efficacy of the antidepressants. When getting into a discussion with about antidepressants with a...
Irving Kirsch (the psychologist who has argued that antidepressants offer a marginal advantage over placebos) has agreement from an unlikely source- advertisements from a pharmaceutical company, which agree completely...
The American Psychiatric Association (APA) has posted a response to the 60 minutes segment on Irving Kirsch and the placebo effect in antidepressant research. But is their response based on scientific data?
Last night, 60 Minutes presented the work of Irving Kirsch, who has been researching the placebo effect in antidepressants for many years. We discuss.
It is refreshing that The New York Times in the space of four days has published two articles which take a critical view of...