New Analysis About Suicidality/Suicides in Adolescents on SSRIs and SNRIs...

[daru1]

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I'm just going to leave this here; I think the media is going to have a field day without reading a word of the research -- and it's limitations and/or conclusions:

http://www.bmj.com/content/352/bmj.i65

 

[WisNeuro]

Nothing new, big takeaway seems to be that pharm studies selectively omit a lot of pertinent information. They do this all the time, it's one of the reasons people think Aricept monotherapy works.

And yeah, the media will have a field day, and, because people do not understand how odds ratios work, they will widely misinterpret the results in their reporting.

 

[2amfrappucino]

From the report:
Conclusions Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately. In adults there was no significant increase in all four outcomes, but in children and adolescents the risk of suicidality and aggression doubled. To elucidate the harms reliably, access to anonymised individual patient data is needed.

And this: "Six suicides were reported, one in the duloxetine lead-in phase. Post-randomisation five suicides were reported: two in the study drug group, two in the placebo group (odds ratio 0.58, 95% confidence interval 0.07 to 4.48), and one in the imipramine group (see supplementary data C and D)."


So how is this study at all valid?

 

[WisNeuro]

It's a starting point. Validity and reliability aren't dichotomous variables. There is some information here, it could just be improved considerably with additional information. Also, this wasn't a study per se, as it was a meta-analysis. So, it relies largely on the validity and reliability of the studies it draws from.

 

[downwithDTB]

From the report:
Conclusions Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately. In adults there was no significant increase in all four outcomes, but in children and adolescents the risk of suicidality and aggression doubled. To elucidate the harms reliably, access to anonymised individual patient data is needed.

And this: "Six suicides were reported, one in the duloxetine lead-in phase. Post-randomisation five suicides were reported: two in the study drug group, two in the placebo group (odds ratio 0.58, 95% confidence interval 0.07 to 4.48), and one in the imipramine group (see supplementary data C and D)."


So how is this study at all valid?

The risk of suicidalITY doubled specifically for adolescents. The risk of suicide (what you quote) was unchanged (and probably couldn't realistically be addressed because it's such a rare event and they didn't break it down by age, lacked any power, etc.).

Importantly, most of these studies were probably under-powered to detect chances suicide, and the question of whether they can differentiate non-suicidal self injury from true suicidality is valid. However, there is some cause for concern if self harming behaviors seem to occur more frequently in treated adolescents, no? Perhaps a prospective, appropriately powered neutral study is warranted based on this data?

 

[TexasPhysician]

FDA to release the double black box warning for redundancy.