Wednesday, February 13, 2013

Seroxat - The UK Evidence in US Courts



My blog post, UK Seroxat Litigation - Take 2, has received a significant number of hits over the past few days or so. Many of the 'limbo litigants', as I like to call them, are now coming forward and enquiries are also being made regarding those that discontinued and whether the advice they received was poor. I can't really answer that but I do know that there are many documents publically available that don't really shine a good light on Glaxo regarding Seroxat.

Here's an example. It's yet another ghostwritten study regarding the infamous Seroxat [known as Paxil in the US]. This is particularly interesting as it's a UK based document pertaining to a Seroxat study [704] [fig 1]





You can see from the document [click to enlarge] that Glaxo hired a ghostwriter, for once Sally Laden can be let off the hook, her fingerprints are nowhere to be seen on this piece. This invoice was sent to Glaxo in 2003 by Complete Medical Communications Limited (CMC), they're the folk who wrote the Seroxat 704 manuscript that was later to be purported to be written by Geller DA, Wagner KD, Emslie G, et al. In fact Glaxo's lack of transparency still exists today in 2013. The paper ghostwritten by CMC still lists the aforementioned as its authors on the GSK clinical study register here.

CMC, according to a 2011 snapshot of their website, "is committed to providing solutions that achieve the optimum balance between scientific integrity and commercial insight, using innovative approaches to help achieve your goals - we produce work of unrivalled quality with exceptional delivery to be proud of.

"Approximately 40% of our team comprises medical writers or editors - 90% of these possess higher degrees with post-doctoral research experience within major pharmaceutical companies or academic institutions."


Here's the invoice they sent to Glaxo:


fig 1


The figure of £7999 is, as the above document suggests, the "Final fees..."

Step back approximately one year earlier and we can see the status of 704.

Karen Wagner, she of many pills for pediatric claims, is seen on this particular document. [fig 2] "{GSK: Please provide a paragraph about sponsorship - Dr Wagner asked for the previous one to be removed}."

fig 2


704 was a study aimed at targeting children between the ages of 7 and 17 who had [ahem] Obsessive Compulsive Disorder (OCD). It was eventually published in 2004 under the title "Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial."

98 patients took Seroxat whilst 105 were given placebo (sugar pill)

Out of the 98 patients on Seroxat, 9 showed hostility (a side effect still today played down by GSK) while only one in the placebo group showed hostility.

The third document [fig 3] from this series of ghostwriting UK styleeee, shows an email from Michaela Cain at CMC. She writes to Eric Dube at GSK:

"Dear Eric

"Currently we have 3 manuscripts in progress based on studies 676, 704 and 453. Those from Studies 676 and 704 are very near to completion and I just wanted to confirm how we should progress. Previously Julie Wilson co-ordinated distribution of the manuscripts to the GSK reviewer's and collation of their comments, while Dave Carpenter liaised with the external authors. Would you like us to now liaise directly with the GSK reviewer's?

"Also, once approved by the authors and GSK team, CMC were due to send these manuscripts to Heather Welch for distribution around the GSK final approval process before submission. Can I just confirm that this will still be the case."

fig 3

Although the 704 study was aimed at kids it highlights how Glaxo operated back then [in that era] If they were showing a lack of compassion for kids in studies then what were they doing regarding adult studies?

I shudder to think... in fact, I did a lot of shuddering when tapering off Glaxo's Seroxat!