GSK Lawyers target Seroxat campaigner Bob Fiddaman – what next?

What next indeed – I think we should all carry on discussing this matter and it seems like more and more people are…

• Does GSK Love Bad Publicity? (Clin Psych Blog)
• Video sets GlaxoSmithKline Hounds to Intimidate British Blogger (AHRP Blog)
• This U.S.A. blog supports Bob Fiddaman (Soulful Sepulcher)
• Glaxo Smith Kline (Bipolar Blast)
• It’s Groundhog Day for bullying by GlaxoSmithKline over Seroxat (Scientific Misconduct Blog)
• GSK Lawyers target Seroxat campaigner Bob Fiddaman (Seroxat Secrets)
• Tony Nunn
• Intimidation: a standard tactic? (Matt Holford)
• Glaxo Goes After British Blogger’s Video (Furious Seasons)
• GSK Video – The Aftermath
• Pharmagossip
• BLOGSCAN – GSK Lawyers Have Paxil Video Taken Down
• Missisyphus’s Weblog: Bob fiddaman’s video about paxil
• An Angry Blogger And Free Speech (Ed Silverman of Pharmalot and the Star-Ledger of New Jersey)
• Pharma Freaks Out, Fiddaman Under Fire
• Coalition Of Parents Enduring Suicide
• Pharma Freaks Out, Fiddaman Under Fire
• SSRI Forum: GSK, helping people feel threatened

I think that particular attention should be paid to this link – where Bob Fiddaman himself posts a copy of the letter from Glaxo’s solicitors, Addleshaw & Goddard, and asks a few questions that Benbow or Addleshaw & Goddard should answer.

Benbow in particular does have some serious answering to do. He has to explain in detail why public comments he made were truthful (or otherwise). If not truthful, he has to explain whether he lied, was duped by his employer, or whether he failed to examine the facts before making public statements. He has to respond in detail both as a scientist and as a medical doctor. And he has to respond in public. It is inappropriate for a public scientific figure to claim harassment when asked to justify crucial (and potentially lethal) public scientific statements that he made.

In all this let’s not forget what Benbow is defending at the moment – that being the way Glaxo has wriggled out of a criminal prosecution in the UK on a technicality.

Here’s a handy timeline of events:

1998 — GSK completed two trials involving the use of Seroxat in children, which failed to demonstrate that it was effective at treating major depression in children.

September 2002 — In a further seven trials, the last of which ended in September 2002, Seroxat’s efficacy for treating children with major depression was not demonstrated.

November 2002 — The MHRA asked GSK about the status of clinical trials in children and the company indicated that it intended to submit an application for paediatric indications. It did not raise any concerns about a lack of efficacy or adverse reactions during clinical trials.

February 2003 — Unprompted, GSK sent an update to the MHRA on clinical trial data it held in relation to suicidal behaviour. However, adult and paediatric data were not differentiated and any safety signal from the paediatric studies was lost when the two populations were mixed since the adult population was much larger.

May 2003 — At the end of a meeting with the MHRA to discuss the safety of Seroxat, GSK handed out a briefing document relating to an application to extend indications for Seroxat to include children. In it a safety concern related to suicidal behaviour among depressed children taking Seroxat was highlighted. The MHRA subsequently requested full clinical trial data from GSK, which showed that the safety concern became apparent after a meta-analysis of the trials was conducted.

June 2003 — The lack of efficacy together with evidence of a causal association between Seroxat and suicidal behaviour in children led the MHRA to advise that it should not be used in the treatment of depressive illness in the under 18s.

March 2008 – the MHRA’s CEO Kent Woods concluded “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them”. The prospect of obtaining a criminal conviction wasn’t “realistic,” because the legislation in force in 2003 – when the investigation began – wasn’t clear enough, especially concerning the disclosure of data and off-label use, the MHRA said in a statement. Glaxo and individual Glaxo employees declined “invitations to attend interviews,” the MHRA says, but did provide three written witness statements – two on behalf of the drugmaker and one on behalf of an unnamed employee.

For the full story on the investigation see:

Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

This is how Glaxo hid data and fooled us all

Glaxo’s spin on hidden Seroxat data scandal and Alastair Benbow’s memory loss between October 1998 and May 2003