Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
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Friday, October 30, 2009

Yesterday's Meeting with MHRA and Janice Simmons [Seroxat User Group]

Meeting fellow advocates who dedicate their time and energy into helping others can be an uplifting experience. I have corresponded with many but met very few.

Yesterday I travelled to Peterborough to meet up with Seroxat User Group campaigner, Janice Simmons, and MHRA Communications Director, Simon Gregor.

I arrived in Huntington and was greeted by Janice at the train station, we had never met before but the 'connection' was made instantly upon meeting.

Janice has been campaigning and helping thousands of people for years. She, like myself, does this voluntary, she, like me, is concerned about SSRi use, she, like me, thinks the MHRA should be doing more.

We had an hour before Simon Gregor arrived so Janice drove the short journey back to her home. It was there where I saw just how active Janice is in her fight. Her computer room is akin to a vault of printed emails, internal documents, years of hard work and passion.

Janice has met with the MHRA on a number of occasions, she has sat with MHRA CEO, Kent Woods, and aired her concerns, she has provided the MHRA with countless documents. Janice has also met with Prime Minister, Gordon Brown to discuss the problem of SSRi's.

I have nothing but respect for Janice Simmons. With over 40,000 emails sent to her over the years, she logs and answers every single one, in fact it could be argued that Janice receives more emails than the CEO of the MHRA, Kent Woods, unlike Kent, Janice answers every single one, she sees them all as being of equal importance. A lesson that Kent Woods should take on board.

We briefly discussed the new 580 page N.I.C.E. clinical guidance that was released 24 hours previously. We, along with the MHRA, have been waiting for this to be published so we can all move on to 'phase 2', which would be to get the British National Formulary [BNF] to alter the wording with regard to guidance on withdrawal for SSRi's. Currently, the guidance in the BNF is pretty slim to say the least.

The new guidance touches on that word 'addiction' again and it is very interesting, if not contradictory, to see the N.I.C.E. criteria for addiction. I, along with Janice, believe Seroxat is addictive, I have my own personal experience with it where as Janice has over 40,000 emails of people writing her telling of their horrific withdrawal stories. Are all SSRi's addictive? Yes, I believe they can be, I cannot be any broader than that as Seroxat was the 'chosen' one for me.

Simon arrived and, to be fair, was cross-examined by myself and Janice for approx three and a half hours. We spoke of addiction, withdrawal, the pharmaceutical industry, the yellow card system, swine flu - where we [Janice and I] think the MHRA are going wrong. It was another chance to air our grievances and another chance for a representative from the MHRA to sit and listen to patients [or patient advocates].

Simon has took up the mantle of speaking to patients [and/or advocates] because he believes it is a way forward for the MHRA. Without these discussions the MHRA would, I believe, stand still.

Janice and I made a few recommendations with regard to the print-outs for Adverse Drug Reaction reports [ADR's]. As no minutes were taken [because it was basically an informal discussion] I cannot recall each of the printed ADR's Janice showed both myself and Simon. I can recall that there has been over 32,000 ADR's for Seroxat. One recommendation we made was to have the ADR's to be more specific. For instance how many of the 32,000 was due to withdrawal problems?

I think we can safely assume that the 32,000 figure is well below the actual figure, if we multiply that sum by 10 then we have a more realistic figure. So 320,000 ADR's on Seroxat alone - quite alarming. It is unknown how many of these are duplicated [from the same person] but nonetheless alarm bells should be ringing at such as huge figure. We touched on the military and the reporting of ADR's too. To be honest, and I don't think he will mind me saying, the military and ADR's had not occurred to Simon before yesterday's discussion. Evidence that these types of discussions can be beneficial.

Simon Gregor does not have all the answers, he has never professed to have them all. What he clearly has is a tool, a valuable tool. That, ladies and gentlemen, is people like myself and Janice who can take the MHRA down roads where they have never ventured before.

Talking with patients and patient advocates is a step in the right direction. Critics, of which I know there are many, will claim these discussions are pointless and it is merely a way of the MHRA stifling our voices.

Simon and others at the MHRA are more than aware that no discussions or top level meetings will stifle my voice. One could argue that this blog, along with others has opened the doors to these types of discussions. One only has to look at the first ever post on this blog, it was in 2006 - I was pissed off at the MHRA for ignoring me. I never in my wildest dreams envisaged some three years down the line myself and a Communications Director would be in the same room discussing the regulatory system.

Was yesterday beneficial? I think so... I hope so.

The MHRA have a lot of catching up to do because they have previously been about as open as a virgin's legs, about as welcoming as a box of rattlesnakes.

Personally, I believe, huge strides have been made to alter the lack of transparency within the MHRA. They are trying but they still have a long way to go. Their CEO, Kent Woods, should take a good look at what Simon Gregor is trying to achieve. Kent should come to terms with the fact that the most important people are patients and if he genuinely wants to turn things around then he should not only listen but he should correspond too. Just because our names don't have 'Doctor' or 'Professor' before them does not make us or our opinions less valuable.

So, where do we go from here? Who knows? But to be at this stage when approx three years ago I was talking to a wall, is a slight achievement.


Will we meet again? Most definitely. Both Janice and I have a vision of a whole bunch of advocates and pharmaceutical industry executives sitting round a table with the MHRA. Personally, I'd like Glaxo's Alistair Benbow and/or GSK Chief, Andrew Witty, to sit in the same room as me and for them to tell me that my personal experience with Seroxat had nothing to do with their company. I'd then like them to tell me that the thousands of others suffering withdrawal at the hands of their drug had nothing to do with their company. The same would apply to any other patient and pharmaceutical chief.

Nothing is impossible. Talking is a good starting point.

For the record, my travelling expenses was paid for by the MHRA - that being a train ticket from Birmingham to Huntington [and back again].

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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