Some of you may know that I have been requesting information from British pharmaceutical giant GlaxoSmithKline regarding comments made by their employee Alastair Benbow on national TV and to BBC investigative journalist Shelley Jofre.
A recent document that surfaced shows an exchange of words between Benbow and Jofre from October 2002. This actual transcript shows Jofre press Benbow for an answer regarding Seroxat withdrawal, much of the transcript never made the final edit.
My request to GSK was thus:
To whom it may concern,
1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, "... the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.
2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim. The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.
On Thursday August 11, I wrote a scathing article and published it on my blog. An hour or so before I published the article I announced on Twitter, "**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub - Keep your eye on the Seroxat Sufferers blog" [Fig 1]
At 4.47pm, just 13 minutes before I was due to publish my article, GSK replied to my request, a request that I had sent them three times!
When I say replied, it was basically GSK side-stepping what I had asked for.
Here's the reply:
Dear Mr Fiddaman,
Thank you for contacting the Medical Information Department at GlaxoSmithKline regarding our product Seroxat* (paroxetine hydrochloride hemihydrate) and thank you for providing us the transcript of the Panorama interview.
You have requested information on study/studies that substantiate some selected quotes from Dr Alastair Benbow with regard to Seroxat during that interview back in 2002. Dr Benbow is no longer with GlaxoSmithKline and therefore it would be inappropriate to attribute substantiation data to him without any consultation. However, the tenor of what is quoted is supported 9 years later in the current prescribing information for Seroxat, namely that:
· in clinical trials adverse events seen on discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo;
· generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity;
· generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more)
For your information some of the clinical trial data for paroxetine in terms of nature and frequency of withdrawal reactions are available in the public arena and discussed via the information presented on p126 of the CSM EWG report of 2004. Lastly, and as before, information about GSK’s clinical trials is available on the GSK Clinical Trial Register at GSK.com.
You will notice GSK's selective choice of words, such as, “generally” and “most”. What I actually requested were the studies that could back up Benbow's claims. So I wrote back the following:
With respect, you have not provided me with the information I requested.
Your employee, Alastair Benbow made the statements on national TV.
I would like to see the evidence that backs his claims.
If I wanted a snapshot of a patient information leaflet I would have downloaded one. You are not being transparent here.
As yet, GSK have not replied to me.
It is interesting to learn that Alastair Benbow is no longer with GSK, quiet convenient that the one person who has the answers to why he said what he did no longer remains as GlaxoSmithKline's spokesperson.
So, in essence, I have requested studies that back up Benbow's claims - GSK cut and paste information off the Seroxat patient information leaflet and send it to me.
Clearly not good enough! I'll keep you posted should GSK ever send me the evidence that supports Benbow's claims.
Back story: **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub
ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING
AUSTRALIAN ORDERS HERE