Seroxat/Paxil/Aropax (Paroxetine) : The Anti-Depressant that makes you want to kill yourself!..
Change in Chicago: Whose Problem?
Courts are not a place you can make jokes. I started off with a confident pitch:
If you owe a bank a million pounds, you have a problem but if you owe the bank a billion …
I didn’t get much further. It felt like several GSK lawyers popped up, addressing the judge with words to the effect that he’s talking about banking your honor, this is not his area of expertise. The judge accepted their objections and I didn’t get to complete the analogy.
Nobody knew what I was talking about anyway – pounds? What are pounds?
Judge Hart also ruled out the following image. So the jury never got to see it.
A lot of my testimony centered on working through each of the ways to hide the data listed here. The exhibit couldn’t be shown but this is what was covered – in some ways too well. There were documents showing correspondence between GSK and FDA on many of these points leaving the jury wondering whether GSK or FDA were more to blame.
Many of the things that were done were shocking. GSK and other companies dumped withdrawal related suicidal acts into the placebo arm of trials, inflating the risks of placebo and breaching FDA regulations in the process. A good deal of this was so blatant that the jury must have been left wondering whether FDA reviewers were asleep or out to lunch.
Suicidal events were coded under the heading of emotional lability. When a journalist and lawyers independently spotted this coding trick and it became a public issue, emails circulated within FDA asking what emotional lability actually was, and where it had come from. But Andy Bayman for GSK could show the jury the documents sent into FDA which showed suicidal events clearly coded as emotional lability. This naturally cast doubt on whether FDA could have been as ignorant of what was going on as FDA head honchos later claimed to be.
Another egregious trick was the use of patient exposure years. This gives rise to the Space Shuttle fallacy. If you calculate lives lost per miles traveled the Space Shuttle may be the safest means of transport in the universe. But it takes a brave person to go on one.
This is because in terms of exit from and entry to earth’s atmosphere the shuttle is highly risky – just like antidepressants where its the starting and stopping that are the problem. GSK and other companies continued some people who were happy as clams on their paroxetine for lengthy periods of time and mixed these with the patients having difficulties to dilute the problem. All of sudden, per year on treatment, the antidepressants looked safe. This is a legitimate approach for some problems but not for this one.
Another trick was putting suicidal events in a neurological category that also included dizziness and headache. These happen so commonly they drown out the signal from suicidal events.
Every time a maneuver like this was exposed, GSK looked bad. They looked like they owed the jury and the public money – a million dollars. The problem is though, they hold all the data. No one could give the jury the data from these GSK trials and say “here you are – its not rocket science – you work out what this data shows”.
While this is the case GSK effectively owe us Billions and its us who have the problem. They own us. And don’t seem to be under any onus to stop owning us.
But GSK interrupted my efforts to lighten the jury’s day by making this remark. A Court is not a place for this kind of thing.