I was going to take a break this weekend as I'm in Washington DC taking time out from a hectic week of traveling to and from the Chicago courthouse where GSK are claiming Paxil does not cause suicide in adults. Furthermore, GSK claims Paxil did not cause 57-year-old Stewart Dolin to end his life by jumping in front of a train. GSK's argument is that Stewart Dolin had 'work-related' problems which caused him to jump. GSK claims the Paxil he was taking as prescribed had nothing to do with his akathisia-induced death.
Earlier this week three video depositions were aired to the jury, they featured former GSK CEO, JP Garnier, Former Glaxo Executive Jeffrey Dunbar and GSK biostatistician John Davies.
Much to my delight, the video depositions have now been released to the public - this is a unique move and one that makes me very happy indeed.
Today I'm going to focus on one of these three videos. It features former GSK CEO, JP Garnier. After watching the video you will hear audio that wasn't aired in court. It, once again, features former Glaxo CEO, JP Garnier. It is audio that has been public for many years and, in the context of his video deposition, shows how Garnier had an opportunity to inform the public about Paxil's suicide link but chose not to. He instead opted to hang-up the telephone live on air.
It's important that you watch the video first then listen to the audio.
In the video, we hear JP Garnier answer questions about GSK's responsibility to warn doctors and patients that Paxil can and does induce suicidality. In Dolin Vs GSK, King & Spalding (GSK's defence team) have already told the jury during opening arguments that Paxil does not cause suicide in adults. Furthermore, they have claimed they told the FDA that, after reviewing Paxil data, they wished to change the drug labeling. According to GSK, the FDA chose to use its own wording rather than using GSK's. King & Spalding told the jury there was nothing else they could do regarding labeling. Garnier's testimony, however, suggests that was a bold-faced lie.
The video deposition was taken in 2006.
"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"
Garnier answered, "Yes, but in practice, you don't want to do that."
He was then pressed, "Okay. But you can do it if you want, the law allows that to occur?"
Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."
So, Glaxo's own CEO claimed in 2006 that there was a legal right to inform the public about any serious adverse event--including the most serious of them all, suicide.
Now, let's listen to an interview from Garnier taken in May 2008, some two years after he admitted (under oath) that he and his company had a legal obligation to inform the public about serious adverse events and that they did not have to go through the FDA to get this news out.
Garnier was being interviewed by BBC correspondent, James Naughtie, about a vaccine. However, Naughtie deviated from the subject of vaccines and chose to ask Garnier about Seroxat (known as Paxil in the US). Garnier, when pressed, chose not to discuss. Now, didn't he have a legal right to do so, as he claimed in his 2006 video deposition? Instead, Garnier chose to hang up the phone and end the interview.
(Hmm, so much for having a legal duty to inform the public.)
I'll leave it up to you, the reader/listener, to decide whether or not you think Glaxo's former CEO had ample opportunity to inform the public about Paxil's serious adverse events.
Here's that classic audio... the discussion of Paxil starts at the 3.24 mark.
Just sayin'.
Over to you, Todd.
**COMING UP TOMORROW**
The video testimonies of former Glaxo Executive Jeffrey Dunbar and GSK Biostatistician John Davies.
Bob Fiddaman.
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