As the latest outing of GSK's Study 329 simmers and the finger of blame from Glaxo's point of view is aimed at technology, whilst the original authors of the JAACAP article point their fingers in the direction of, well, um, everyone but themselves, I thought I'd take a trip down memory lane.
Thank goodness for this old blog of mine.
Back in 2013, I wrote about a 2008 study I had stumbled across. The study, sponsored by GlaxoSmithKline, was carried out in Japan. They wanted to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.
The target population?
I kid you not.
Here's the original post of mine. Pay particular attention to Glaxo's recruitment poster. One has to ask why, after the failure of study 329 and 377, Glaxo wanted to trial paroxetine out in more kids.
Here's the 2013 blog post of mine...
Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts to push Paxil [known as Seroxat in UK] on kids in Japan.
I was so outraged at this that I wrote to the Japanese Embassy and the Japanese Ministry of Health, more or less to give them a detailed view of how GSK had previously claimed Paxil was safe for kids to take...when in actual fact they knew that it wasn't.
I never heard back from either one of them.
I also contacted GlaxoSmithKline in 2010, you can see the email I sent to them (link at foot of this post).
In 2008, one year before I broke the news, Glaxo were recruiting kids for a clinical study. I say Glaxo, they, in actual fact were sponsoring the study.
The study was designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.
Oral paroxetine is a sickly orange syrup, I've been on it myself. It was the only safe way to taper from this highly addictive antidepressant.
And just who were being used as the guinea pigs in Japan?
One look at the inclusion study criteria would have showed you.
Ages Eligible for Study:7 Years to 17 Years.
Yup, that's right folks. Despite being dragged through numerous courts in the US where evidence was shown that Glaxo manipulated previous clinical trials in children, here they were again back in 2008 recruiting more kids.
A marketing campaign went out in the form of a poster... which I just happened to obtain from a source at Medwatcher Japan. Medwatcher were also furious at this particular clinical trial involving kids and Paxil.