The doctors, psychiatrists and pharmaceutical companies who are involved in this all share equal blame here..

It is absolutely and totally unjustified to prescribe SSRI’s to babies and children..

As an adult who was prescribed this drug at 21 years of age, I can attest that these drugs are highly dangerous at any age..

Anyone involved in the marketing an promotion of these drugs should be deeply ashamed of themselves..

I guess I’m asking more about the socio/psychological aspects of off-label prescribing. How does something that on the face of it is so appalling (at least to me) become a fairly accepted practice? Justice? You around?

One can ask the State of New Jersey the same question. Their medicaid prescribing data is just as appalling as the Australian data.

“That said there are things that are black and white that the pharmaceutical industry tries to make us see as shades of gray.”

Now that’s a statement I can agree with. It’s that situation that the problems happen, and people are harmed.

Off-label prescribing can be either done appropriately or inappropriately. Even when done appropriately there may be deaths and that makes inappropriate off-label usage and its promotion even more abhorent to me than usual. Even labeled usage can result in the inappropriate deaths of children if the labeling is inadequate.

It is not uncommon in medicine that even the most careful and attentive person does what the science says is the best at the time only to find out later that it was inappropriate. For a child to die under those circumstances is tragic.

What I have problems with and which is clear, is that the industry is promoting inappropriate usage (both on-label and off-label) and in my mind under those circumstances for a child to die is criminal and whoever from the industry, academia, or FDA who are involved should be held accountable.

Things are not all black and white. There are shades of gray. That said there are things that are black and white that the pharmaceutical industry tries to make us see as shades of gray.

The only way for us to know what is truly appropriate is to get all the data.

I don’t believe I misread your statement at all.

You were talking about how studies by a KOL can influence prescribing. I was agreeing with you. However I thought your post may have inadvertantly implied that it was only appropriate studies by Biederman that influenced prescribing.

What I did was simply point out that Biederman’s studies may not all be appropriately done and as a KOL his publications (and presentations) should not be done in such a way so as to give any credence to irrational and unsupported practices. As a KOL he should know that just having a name and title and/or a tenative conclusion can influence prescribing.

Salmon

You are all debating on label, and off label prescribing of psychytropic drugs in children..I just have one question,… are any of you willing to accept the responsibility… for the death of the child?

Again, you misread my statement. was broadly commenting on Harpy’s concern that clinical studies of off-label indication encourage physicians to prescribe off-label. I mentioned that the only way to get a new labelled indication is to do one or more studies on indications that are off-label. I made no mention or judgment of Biederman.

Atlex

Maybe I’m optimistic, but I’m assuming that pharmaceutical companies aren’t stupid enough enough to market antidepressants for use in babies - their self-interest probably isn’t served in doing so. Of course, I wouldn’t have figured that doctors would prescribe it, so maybe my estimate of the lower limit of stupidity is too high.

Beiderman has been involved in randomized double blind placebo controlled clinical trials when they are designed and paid for by companies and these typically include patients in the 13 -17 year old range. These are studies that the companies are going to use them for approval purposes. However if you look at the studies themselves, e.g. for Zyprexa they’re mainly 15 - 17 year old patients with the most severe cases of mania (average mania score of 32 with SD of ~2).

Whereas what has been pushed is usage in kids down to as young as 4 and from the descriptions probably have mania scores in the single digits.

If you look at his publications his published support for this usage are nonrandomized historical case series. In essence he’s saying I put these kids on drugs and I thought they did better. It’s not even clear that a proper diagnosis has been made or there’s any oversight. It is these publications that he leverages into promoting use of the drugs in younger populations. I doubt that the companies themselves or the FDA would accept these as adequate and well controlled.

It’s easy to look some of these up. Just go to ClinTrials.gov