Look at the above table. On the left are data from the FDA showing an increased risk of suicide on active treatment. On the right are the current data that the FDA, upon which the recent FDA panel made its recommendations about the risks of SSRI treatment.
David Healy presented the above slide in his testimony to the FDA about a week ago. Below, I present some excerpts from his speech made that same day:
“This study presented by FDA over 3 years ago shows a clearly increased rate of suicides on active treatment. There were more patients, suicides and trials in this study than in the material FDA have presented to this meeting, and this study included withdrawal suicides.
FDA got their 2003 problem to vanish by controlling for age, sex, and the location of the trial giving the results you see on the right.
But if age and sex were substantially imbalanced in these trials, then the studies must have been invalid.
Regarding study location, this year FDA cited lower rates of suicide in
At the 2004 PDAC meeting, FDA did not have all the pediatric trials. I bet they don’t have all the adult studies I’ve seen. We know for certain that all of the 2003 material is not included today. Do you know why not? I know FDA do have the placebo suicide who was taking an antipsychotic, antidepressant and 2 benzodiazepines, but don’t know what they’ve done with him. Do you?”
Healy apparently concluded his remarks with this: “So Truth of Fiction? Well the FDA document and presentation are exceedingly strange and this might following Mark Twain suggest truth. But there is too much blatant manipulation of the data for that. We are left with fiction; perhaps the strangeness derives from the fact that we are missing a key element of a good fiction, namely the final line as to who is doing what to whom.”
For more on the magically changing FDA data on SSRIs and suicide, see my earlier post. Always keep in mind that sponsors were responsible for providing the data, and the sponsors have a history of manipulating the placebo suicide data to make placebo appear more risky. Not that one can entirely blame the sponsors, as FDA has been fully compliant with this manipulation of data. To see how rose-colored glasses have been worn when interpreting the SSRI-suicide data, see another earlier post, which also discusses some of Healy’s work.
There's more to be said about the FDA's handling of this data. Thanks to an anonymous reader for providing me with the chart and speech excerpts.