Tag: antidepressant withdrawal

Access to data is more important than access to information about conflicts of interest. It is only when there is access to the data that we can see if interests are conflicting and take that into account. Problems don’t get solved unless someone is motivated for some reason. We need the bias that pharmaceutical companies bring to bear in their defense of a product, along with the bias of those who might have been injured by a treatment. Both of these biases can distort the picture but it’s when people with differing points of view agree on what is right in front of their noses that we can begin to have some confidence about what we have.

By 2002 GlaxoSmithKline had done 3 studies in children who were depressed and described all three to FDA as negative.  As an old post on Bob Fiddaman’s blog reproduced here outlines, several years later they undertook another study in children in Japan. (Editor's note: This is a re-print, by David Healy, of a post by Bob Fiddaman)

One of psychiatry's most obvious vulnerabilities is the fact that various so-called antidepressant drugs induce homicidal and suicidal feelings and actions in some people, especially late adolescents and young adults. This fact is not in dispute, but psychiatry routinely downplays the risk, and insists that the benefits of these drugs outweigh any risks of actual violence that might exist.

In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. The consent form says that anyone entering the study would be treated just the way they would be in normal clinical practice. In Study 329, the children taking imipramine were by design force titrated upwards to doses of the order of 300 mg, which is close to double the dose of imipramine given in adult trials by GSK or in normal clinical practice. In normal clinical practice it would be usual to inform somebody who had become suicidal on an SSRI that the treatment had caused their problem.

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.

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 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.