If you really want to do something useful.

See the comments from the following post about the FDA reviewer who is being fired

(http://www.pharmalot.com/2008/10/preemption-the-business-case-of-the-century/#comments)

and get people to have Congress look into it.

The person is a pediatric psych drug reviewer.

An FDA Reviewer

First, this is not a Pfizer sponsored study. Based on the stusy’s write-up, Pfizer was only asked to supply study medication and nothing more. There is no reason for Pfizer to sponsor a study for Zoloft since the product has lost exclusivity (almost all use of sertraline is in its generic form and not branded Zoloft). For that same reason, there is no entity with any interest in taking this study to the FDA for “approval.” Your speculation has no basis in reality or logic; it amounts to nothing more than baseless conspiracy theory.

Atlex

Do the two of you really care about the validity of this study? Then tell the NIMH and Pfizer to release the “RAW DATA”…… Its just that simple!!!

One only has to ask two questions in regards to the Zoloft Study…

Does this Study meet the requirements for FDA approval?

Why was this study not!.. presented to FDA approval.

These are the only two questions that matter!… Who the Hell cares what the Media or the Industry apologists have to say.

I was simply sloppy and thought that the 2 cases were both on Zoloft.

Salmon

Be my guest to stand by completely made up data. Go look at the study itself. Your data is incorrect. See Table 3 at this link.

http://content.nejm.org/cgi/content/full/NEJMoa0804633#T3

Atlex

I stand by my remarks regarding suicidality.

Suicidality includes not only suicidal and homocidal ideation and suicide attempts but actions such as self injury and even thoughts of self harm. These are metrics that Columbia University used when they verified the conclusions of two different groups of FDA reviewers on suicidality with antidepressants in adolescents.

The rate of suicidality was approximately 2 out of 300 on Zoloft. I’ve seen raw data on suicide and suicidality rates in other studies and the rate of completed suicide for other drugs is typically around double the rate of suicidality. Based on the sample size for the entire study and the rates of completed suicide for other drugs I would have to say that even before the study began it should have been obvious to anyone familiar with the expected rates for antidepressants that there was a very low chance of seeing any completed suicides.

It’s very important that companies include enough subjects in these studies to properly evaluate the risk, otherwise it’s likely to be entirely missed in practice. This is simply because of the numbers.

A typical child psychiatrist can only see about 500 patients a year and fewer are going to be on any particular drug. Thus a child psychiatrist might see 1 suicide every several years and they are likely to think that it’s the underlying disease and not think it’s the drug. Only companies and the maybe the FDA are likely to collect sufficient postmarketing safety information to make the connection.

Salmon