Monsanto Roundup Lawsuit

Friday, June 04, 2010

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV




I struggled with coming up with a title for this post. Often headlines can sum up what the content of an article is - the above title could mean anything but it is one that I intend to show in this article regarding Seroxat withdrawal and the way that, for years, both GlaxoSmithKline and the Medicines Healthcare and products Regulatory Agency [MHRA] have chose to ignore the blindingly obvious.

I can only draw opinions as to why they have both chose to ignore. In Glaxo's case, I am of the opinion that they wished to play down that there was a problem with Seroxat withdrawal because it would affect sales - I cannot think of any other reason why?

Regarding the ignorance of the MHRA on the Seroxat withdrawal issue, my opinion remains the same as it has always been. They allowed a drug on the market, they have stood by and watched people take it, they have sat with Seroxat patients and advocates and listened - They have done nothing. Two schools of thought here;

[1] The MHRA are wholly funded by the pharmaceutical industry, GlaxoSmithKline included - so, why bite the hand that feeds you?

[2] To admit they were wrong would create quite a stir. People, myself included, would ask, at what point they realised they were wrong?

I tend to lean toward point [2] where the MHRA are concerned. An admittance of 'We messed up', would make them look incompetent and calls would be made for a restructure of the whole medicines regulatory system.

I am in no doubt that the MHRA are in bed with the pharmaceutical industry, in particular GlaxoSmithKline.

For a while they convinced me that they were actually on the side of the patient - until I started asking them 'awkward questions', questions that they chose not to answer. I think I know why they chose that route and recent evidence I have obtained has made my skin crawl, so much so that I intend to take a shower after finishing this article.

When Seroxat patients have turned toward the MHRA for support, they have listened. When Glaxo turn toward ex-employees of the MHRA for support, they get unequivocal loyalty.

All will be revealed in Part II of GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss.

It should be noted at this point that there is an up and coming lawsuit in the UK with regard to Seroxat withdrawal, a lawsuit that I am part of - this, I suppose, could be deemed as a possible conflict of interest. However, it needs someone to point out the failings of GlaxoSmithKline and the MHRA where Seroxat withdrawal is concerned - if only for the future safety of patients and/or to educate those who blindly prescribe Seroxat because both Glaxo and the MHRA have told them that it is safe to do so.

I may also add this article [and Part II] to my book just before it is edited for publication as a paperback later this year. It's important that people who do not have access to the Internet know all the facts regarding Seroxat withdrawal.

Discontinuation vs Withdrawal

Both GlaxoSmithKline and the MHRA prefer to use the term 'discontinuation reactions' rather than 'withdrawal reactions.'

Withdrawal reactions would imply that there is an addiction problem with Seroxat. The word 'Withdrawal' is defined on Wikipedia as thus:

Withdrawal can refer to any sort of separation, is most commonly used to describe the group of symptoms that occurs upon the abrupt discontinuation/separation or a decrease in dosage of the intake of medications, recreational drugs, and/or alcohol. In order to experience the symptoms of withdrawal, one must have first developed a physical dependence (often referred to as chemical dependency).


Whereas 'Discontinuation' is defined on Wikipedia as thus:

Discontinuation is to quit a procedure, and has different meanings for a treatment of an individual and a whole brand of a drug product:

Discontinuation of a treatment is to stop taking a drug. There are several reasons for discontinuation, e.g.:

The ailment or reason it was taken has disappeared.

The adverse effects overweight the desired effects.

Other, better, alternatives are available.


However, 'SSRi Discontinuation syndrome' is defined on Wikipedia as:

SSRI discontinuation syndrome (also known as SSRI withdrawal syndrome or SSRI cessation syndrome, colloquially called the zaps) is a syndrome that can occur following the interruption, dose reduction, or discontinuation of SSRI (selective serotonin re-uptake inhibitor) or SNRI antidepressant medications. The condition often begins between 24 hours to 10 days after reduction in dosage or complete discontinuation, depending on the elimination half-life of the drug and the patient's metabolism. The prescribing labels of some SSRIs note the possibility of "intolerable" discontinuation reactions. Some patients have extreme difficulty discontinuing use of SSRI drugs.


Without sounding patronising to those reading this, I feel it important that those reading fully understand withdrawal vs discontinuation.

As Wikipedia points out when referring to SSRI discontinuation syndrome, it is also known as SSRI withdrawal syndrome.

So, according to Wikipedia, withdrawal and discontinuation pretty much amount to the same thing.

I understand that Wikipedia is not the be and end all of word definitions so let's look elsewhere.

A. http://www.thefreedictionary.com/discontinue

discontinue

1. to come or bring to an end; interrupt or be interrupted; stop

discontinuation n

----

B. http://www.yourdictionary.com/discontinuation

discontinuation

noun

A cessation; a discontinuance.

----

C. http://www.merriam-webster.com/dictionary/discontinuation

discontinue

1 : to break the continuity of : cease to operate, administer, use, produce, or take

dis·con·tin·u·a·tion noun

----

D. http://www.ldoceonline.com/dictionary/discontinue

discontinue

to stop doing, producing, or providing something:

discontinuation noun [uncountable]

----

E. http://www.askoxford.com/concise_oed/discontinue?view=uk

discontinue

verb (discontinues, discontinued, discontinuing) stop doing, providing, or making.

DERIVATIVES discontinuation noun

----

Five examples of the word discontinuation and we can basically see that it means STOP.

Now, I'm a question asker. I have been for much of my life. My school years were cut short after I was expelled in my final year. I missed all of my exams. This does not mean that I am an uneducated imbecile from Birmingham.

Discontinuation when used on a patient information leaflet [PIL] is misleading to the consumer. It's a word designed to camouflage the withdrawal symptoms that exist when one tries to discontinue/withdraw from Seroxat. Some of the symptoms are extreme, although many such as suicidal thoughts, disabling brain zaps, intolerance to sudden loud noises, short term memory are not mentioned on the PIL. Instead Glaxo opt for the obligatory side effects such as nausea, dizziness, diarrhea - the three standard side effects that appear on most PIL's.

I have educated myself regarding Seroxat because there is not one body that can give me answers - not GlaxoSmithKline, not the MHRA and certainly not a doctor from the local community health centre.

My research has taken me on a journey. My withdrawal from Seroxat is well documented both on the Internet and in my book, The Evidence, However, Is Clear...The Seroxat Scandal - Chipmunka Publishing - ISBN: 978-1-84991-120-7

This research has led me to various publications that show that there has been a withdrawal problem with Seroxat for many years, a problem that both GlaxoSmithKline and the MHRA have, it would appear, chosen to ignore.

Combine this with the yellow card reports the MHRA have received regarding adverse reactions to Seroxat and one can only be of the opinion that they [GSK & The MHRA] have known for years about this problem but have done nothing to eradicate it... or at least help those who have had to endure Seroxat's withdrawal problems.

The current Drug Analysis Print for paroxetine [Seroxat] is hosted on the MHRA web site.

It shows that there have been 32,625 reactions to paroxetine. There have been 10,518 adverse drug reactions and 175 fatalaties. The earliest reaction date is noted as being 1st January 1990.


An important titbit of information before you continue to read the evidence.

GlaxoSmithKline have never carried out any studies regarding Seroxat withdrawal - at least not to my knowledge?

I find this utterly staggering particularly when Glaxo's employees have, in the past, made bold statements regarding Seroxat withdrawal.

In 2000, Dr. David Wheadon, Senior Vice President for GlaxoSmithKline Regulatory Affairs and Product Professional Services, went on record with the following statement:

"There have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been."


I have never seen any such study, in fact I know of no one who has...apart from Dr. David Wheadon!

In 2001, the Independent, a popular UK newspaper, ran with an article entitled, 'Serotonin Syndrome – the price of a good mood'

In short, it was an article regarding a woman called Louise Anderson [not her real name] who had came off her medication [Seroxat] and 12 months later was still experiencing "withdrawal symptoms."

Alan Chandler, spokesman for GSK, had this to say:

"There's no reliable scientific evidence to show they cause withdrawal symptoms or dependency."


If, as he claimed, there was no reliable scientific evidence to show they cause withdrawal symptoms or dependency, then could he or GlaxoSmithKline provide any reliable scientific evidence to show that Seroxat DOES NOT cause withdrawal symptoms or dependency?

In 2002 Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, had this to say:

"Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients."


To make such a vague statement when Seroxat withdrawal has never been studied by GlaxoSmithKline is, I believe, very unprofessional and misleading.

In 2005, Mary Anne Rhyne, GlaxoSmithKline spokesperson, had this to say about 'discontinuation'

"If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks."


Question:

How did Mary Anne Rhyne know this if no study had ever been done regarding Seroxat withdrawal?

Again, I believe, this statement is very unprofessional and misleading.

These are just a few of the statements made over the years by GlaxoSmithKline employees in defence of Seroxat.

The Evidence

Glaxo and the MHRA are always asking for evidence. They have, for years, dismissed the thousands of anecdotal reports via online forums, and petitions.

I know the MHRA regularly read my blog, I also know that GlaxoSmithKline employees and their solicitors, Addleshaw Goddard, read it too.

Perhaps, all of them then can explain the following publications where Seroxat withdrawal has been mentioned, perhaps they can all explain why they have ignored these publications?

In 1993, the Committee on Safety of Medicines [CSM], reported 78 cases of withdrawal after 'discontinuation' of paroxetine, reporting that "such reactions have been reported more often with paroxetine than with other SSRI's." [Current Problems in Pharmacovigilance (1993; 19:1).

1993?

Now forgive me for my flippancy here but 1993 was long before Panorama came on the scene with it's 4 programmes regarding Seroxat.

Any individual who uses the media interest [Panorama] as an argument is clearly delusional.

Here we have an instance of Seroxat withdrawal that was put before the CSM. I cannot for the life of me grasp why this did not raise alarm bells, particularly as it is categorically plain and simple - "such reactions have been reported more often with paroxetine than with other SSRI's."

No Panorama programme, no bloggers, no activists, no lawyers threatening legal action - so why was this ignored?

In 1996, Nuss and Kinkaid, studied serotonin discontinuation syndrome, and paroxetine patients in particular. The authors concluded that "with the advent of the..(SSRI), there is now growing evidence to support a 'discontinuation syndrome' associated with withdrawal of therapy." (W V Med J 2000 Mar-Apr;96(2):405-7.)

and

In 1997, Dr. Haddad reported that the highest incidence of discontinuation reactions among the SSRI's was paroxetine. (J Clin Psychiatry 1997; 58 Supp l7:17-1; discussion 220.)

and

In 1998, Dr. Roger Lane's article, Withdrawal symptoms after discontinuation of selective serotonin reuptake inhibitors (SSRIs), was published in the Journal of Serotonin Research (1996, 3, 75-83). After listing the physical symptoms caused by withdrawal, Dr. Lane observed that of all the SSRIs, paroxetine caused severe withdrawal symptoms the most often.

Again, no intervention by the UK medicines regulator. No offer to carry out a study regarding Seroxat withdrawal by GlaxoSmithKline. No demands from the MHRA that Glaxo should carry out such a study.

I'll offer an opinion here.

I believe that both GlaxoSmithKline and the MHRA, the then MCA, totally underestimated the growth of the Internet. They totally disregarded the above publications because, at the time, they were seen by so few.

Sadly, for GlaxoSmithKline and the MHRA, the Internet is a mass of footprints that eventually lead to startling revelations.

It cannot be disputed that the MHRA or Glaxo have never been made aware of Seroxat withdrawal - the papers above prove this as do the number of yellow cards sent to the MHRA.

There are many more publications that, for now, I shall zip up and send on to the solicitors acting for the plaintiffs in the current UK Seroxat Group Action.

They probably already have them, if they don't, then their thanks should go to former Paxil activist, Rob Robinson, who made these publications available on his website, PaxilProtest, some years ago. A website that Rob removed after allegedly being paid a handsome sum by GlaxoSmithKline.

Part II is coming soon. I will show you how GlaxoSmithKline have called upon the services of a former MHRA employee to act as a witness for them in the up and coming UK Seroxat Group Action.

It's an exclusive and after reading, you may want to scrub yourself in the shower as it is likely to make you squirm and feel dirty.

My loofah awaits.

Fid

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