Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, July 23, 2014

For Dame Kelly Holmes

Dear Dame Kelly Holmes,

I have learned recently that you are now Technical Advisor, GSK Human Performance Lab.

I'd congratulate you but any person associated with GlaxoSmithKline [without researching their abhorrent history] kind of leaves a bitter taste in my mouth.

I have approached you on Twitter but you have failed to answer me. I understand that you receive thousands of tweets from fans, admirers on a daily basis so mine may have passed you by.

I am writing an open letter to you, via my blog, in the hope that you will, at the very least, research this British pharmaceutical company who in my opinion, have, over the years, had a complete disregard for human life, particularly where children are concerned.

You may dismiss me as just a blogger who has a gripe against GlaxoSmithKline because of my own personal experience with one of their products - this couldn't be further from the truth as I have, during my 8 years writing and researching GlaxoSmithKline, covered many stories of children killing themselves as a result of antidepressant induced suicide and also children that have been born with serious birth defects as a result of their mother's ingesting GlaxoSmithKline products.

These articles are not conspiratorial, read them and then ask yourself if being associated with GlaxoSmithKline sits right with you.

It's difficult to know where to begin as GlaxoSmithKline have been involved in so many violations, the majority of which have been settled out of court in the United States.

I first started researching GlaxoSmithKline after I had endured horrific withdrawal reactions to their antidepressant Seroxat [Known as Paxil in the US] - I wanted to know why it was taking me so long to taper from an antidepressant that, according to GlaxoSmithKline at the time, only took approx two weeks to taper from. It took me a staggering 21 months. I am one of many thousands who have suffered at the hands of Seroxat.

I'm one of the lucky ones as I have lived to tell the tale.

Others have not been so lucky.

I'd like to tell you about a few of those.

Let me start with Sharise Gatchell [Below], an 18-year-old British girl who killed herself in 2003.

Sharise Gatchell

Sharise was prescribed GlaxoSmithKline's Seroxat at the age of 16 to help with depression and shyness.

Here's what her mom, Stephany, had to say...

"I noticed that there was just a dramatic personality swing and at times I found her hostile and aggressive," Mr Gatchell said.
"I couldn't put it together, I couldn't make sense of this dramatic change."

At the time GlaxoSmithKline made claims that there was no link between Seroxat and suicide. A spokesperson told BBC's South East Today...

"By treating depression Seroxat helps to prevent suicide and the associated suicidal thoughts.
"Numerous investigations by independent bodies made up of doctors who are expert in this field have found no links between Seroxat and suicide."
I'd like you to remember the second paragraph Kelly.

One month after Sharise killed herself Government advisors [The MHRA] ruled that Seroxat should no longer be prescribed to under-18's.

It came a month too late for Sharise.

Cecily Bostock

Cecily Bostock (25), a young Stanford graduate, had been prescribed Seroxat by a psychiatrist for racing thoughts and anxiety.

“She was having a lot of trouble sleeping and she had racing thoughts, and she was over-analysing and she was overly sensitive… that is what prompted the prescription.”, said her mom Sara.

Within three weeks of taking Seroxat, Sara says, her daughter became a totally different person.


"The last two days she was just a complete zombie I have to say. She was just agitated, jumping at every noise and not making sense. I was very concerned. We were very close to Cecily. I just loved her deeply.
"So I went into the kitchen and I turned the light on and she was lying on the floor. And I knew she was dead. And there was a knife on the floor by her and there was just a trickle of blood from her chest.”

Cecily had stabbed herself twice through the heart.

Since her daughter's death Sara has been campaigning and creating awareness about the dangers of  Seroxat and other SSRi type drugs.

Sara attended the APRIL charity conference 2008 and spoke about her experience and knowledge from years of research. This video has finally surfaced.

Here she speaks about Seroxat/Paxil (paroxetine) suicides.

Sara Carlin

Sara Carlin was an 18-year-old graduate of St. Ignatius of Loyola Catholic Secondary School in Ontario, Canada. She began to experience anxiety and visited a doctor in an effort to alleviate it. The doctor prescribed Sara, then 17, Seroxat (paroxetine). 

On Sunday, May 6, 2007, Sara, suffering from the side effects of Seroxat, grabbed a piece of electrical wiring and hanged herself in the basement of her parents' house.

GlaxoSmithKline issued this statement:

"Any suicide is tragic and the greatest risk for suicide is untreated depression.
"Paroxetine has been used by tens of millions of patients and has been proven to be a safe and effective treatment since its launch more than 15 years ago
."The label contains instructions regarding the use of paroxetine and important safety information about the product.
"If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health-care professional.
"Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor."

More about Sara here.

The above three articles feature three young women whose lives were cut drastically short. GSK will have you believe that these are just anecdotal stories and, therefore, cannot be taken at face value.

If either Sharise, Cecily or Sara were high profile sports stars like yourself Kelly then their deaths, or rather the circumstances surrounding their deaths, would have received far more media attention.

I was saddened to hear that you, yourself, have endured depression and self-harm. You will know from experience how this can effect your daily routine, let alone the sport that you excelled in.

Sharise, Cecily and Sara went one step further, they did so as a result of Seroxat induced suicide.

Now Kelly, let me show you exactly what GlaxoSmithKline hid during the marketing of Seroxat. I'm assuming you are not aware of this, if you were then I doubt very much that you would have joined forces with GlaxoSmithKline.

This is what your advisors, or indeed GlaxoSmithKline, have not revealed to you.

GlaxoSmithKline's Paxil 329 study

In a nutsell, Study 329, took discouraging data on the efficacy and safety of paroxetine [Seroxat] in kids and spun it into an article claiming excellent results:

GlaxoSmithKline hired the services of  Scientific Therapeutics Information to 'ghostwrite' a study regarding the use of Seroxat in children and teenagers, the ghostwriter, Sally K. Laden,  was given approx 200 pages of a clinical trial they had carried out using Seroxat. 

In fact the entire clinical study report was over 1400 pages long yet Laden only saw 200 of these. Hardly the basis of drawing up such an important draft, particularly when it involved medicating children and adolescents. 

Nonetheless, Laden came to the conclusion [based upon the 200 pages] that Paroxetine is a safe and effective treatment of depression in the adolescent patient.

Maybe her conclusion was correct on the basis that Glaxo only gave her 200 pages. Maybe Glaxo omitted the other 1200 pages because Laden may have arrived at a different conclusion?

This is for you Dame Kelly. It's Sally K. Laden's deposition [under oath]


Q = George Murgatroyd (Baum Hedlund)
A = Sally K. Laden

Q: So you relied upon GSK in providing you with accurate information, correct?

A: Yes

Q: And to the degree that that information is inaccurate that's not your fault right?

A: It's not my fault?

Q: Yes. If you wrote something in the manuscript that's inaccurate, that was based upon information that was provided to you by GSK, it would not be your fault if you wrote something inaccurate, correct?

A: I guess, correct.

Q: Okay. Now I mean do medical writers have the responsibility to go back and look at the raw data to see if the interpretation of that data is correct?

A: I don't believe so


Q: Okay. You know GSK coded the suicide events in Study 329 as Emotional Lability. Are you aware of that?

A: Yes

Q: Were you aware of that fact at the time you prepared the first draft of the manuscript?

A: I don't know

Q: How did you become aware that that term was being used to cover suicide attempts?

A: It must have been in a document. In whatever document I was given.

Q: Okay. So when you prepared the first draft you knew that Emotional Lability was included?

A: Again, I don t know if I had this at the time of the first draft. I don't know. I cannot say that I had this document that is sitting in front of me at the time I wrote the first draft and I would have to look and see what is in here.

Q: Okay. Well let me maybe back up for a second. When you prepared the first draft of the manuscript were you aware of the number of adolescents who experienced events involving suicidality? Just suicidality events, suicide events?

A: Completed suicide?

Q: No just events involving suicidality?

A: I don t recall

At this point Murgatroyed tells Laden to look at her draft.

Q: Did you find something in the first draft that talks about suicidality?

A: There is the Emotional Lability

Q: Okay. How about suicidality?

A: No

Q: Okay. My question is do you know what the term Emotional Lability means?

A: Emotional means you have emotions. Lability means you re waxing and waning.

Q: Okay. And when you wrote the manuscript did you know that that was the topic that GSK stuck the suicide events under?

A: I don't know.  I don't remember.

Murgatroyed then asks Laden if she was aware that the FDA analysed Study 329 with regard to adverse events. Laden replied, "I am aware of that."

Murgatroyed then showed the results of the FDA to Laden.

Q: And it says drug, meaning Paxil 6.5%,  Placebo 1.1%, Risk ratio equals 5.9%, do you see that?

A: I see that

Q: Do you know what a risk ratio is?

A: My understanding is that it's statistical language comparing one thing with another of the probability of an event happening.

Q: Okay. In this instance an adolescent taking Paxil is almost six times at the risk of experiencing possible suicide related event compared to an adolescent taking placebo, correct?

At this point the attorney representing Laden, Stuart Margohs (Berdon Young & Margohs), interrupts...

"That is one question. The other question is whether or not you can tell if that is a depressed adolescent or not."

Murgatroyed points out that Study 329 was a study involving depressed adolescents.

Back to the questioning of Laden

Q: Do you think it s appropriate to promote Paxil as safe when over 5 percent of the adolescents taking Paxil during clinical trials of 329 attempted suicide?

A: I can't answer that question. I am not an expert to know whether 5 percent is a dangerous risk in a dangerous disease or 50 percent is a dangerous risk in a dangerous disease. An expert would know that. I'm not an expert.

So, you see Dame Kelly, Glaxo knew during the clinical trials of Seroxat that 5% of the children taking it attempted suicide. You'll also note that GSK knew this but, through a ghostwriter, they claimed it showed "Remarkable efficacy"

Would Sharise, Cecily and Sara be alive today if they had been privy to this study that GlaxoSmithKline kept hidden from the public?

Remember I told you earlier in this letter to remember the paragraph "Numerous investigations by independent bodies made up of doctors who are expert in this field have found no links between Seroxat and suicide."

How do you feel about GlaxoSmithKline's statement now?

I'll leave you to ponder on that one Dame Kelly.

GlaxoSmithKline haven't just hid results in Seroxat clinical trials for children and adolescents Dame Kelly.

Joanne Thomas

Joanne Thomas filed a Paxil birth defect lawsuit against GSK in 2006. GSK argued that she was out of time. [Statute of Limitations] The Judge and subsequent appeal panel agreed with GSK.

During a previous Seroxat birth defect trial [Kilker v GlaxoSmithKline] evidence emerged that back in 2001 GlaxoSmithKline had received an email from a mom who had to abort her child because of birth defects.

Internal emails used as evidence in the Kilker trial saw Glaxo officials admit that the cause of these birth defects was related to Paxil [known as Seroxat in the UK]

An internal GSK document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

The woman who sent in the email was, for many years, unknown. Last year she and I corresponded.

I don't know if you have children Dame Kelly, regardless of whether you have or not you will find the story of Joanne Thomas harrowing and may ask yourself why GlaxoSmithKline rejected her plea for compensation on a statute of limitations argument when they knew that she had contacted them in 2001.

Furthermore Dame Kelly, it may also interest you to learn that GlaxoSmithKline sat on the birth defect link for many years...just as they did the suicide link in children and adolescents.

This from the Kilker v GlaxoSmithKline birth defect trial...

[Teratogen is an agent or factor that causes malformation of an embryo, such as the drug thalidomide]

"In May of this year, 2009, a study was published by Doctor Sloot. The study said this.

What Doctor Sloot did is, he took Paxil and all the other reuptake inhibitors and he exposed rat fetuses to these 12 different drugs, including Paxil. And what Shearing Plough was trying to figure out, what they were trying to do was figure out whether one of the drugs that they were going to put on the market to compete with GSK's drug was capable of causing birth defects. And so they took the drug they were going to take to market, and before they took it to market, they did this test. And they compared it to all the other SSRIs. Because, as you will learn, GSK never did this test.

What Doctor Sloot discovered in May of this year is that out of all the teratogens, out of all the SSRIs, the 12, only one was a clear teratogen, Paxil. He discovered that Paxil in May of this year was actually more powerful a teratogen than cocaine.

It would be safer, according to Doctor Sloot's study, to take cocaine than it would be to take Paxil while you were pregnant.

Now, Shearing Plough, quite rightly, took their drug that they were thinking about taking to market to compete with Paxil, and even though it was just a possible teratogen, they scrapped their plans to take it to market and decided the risk was not worth the benefit.

GlaxoSmithKline, Dame Kelly, the pharmaceutical company that you have joined forces with, refused to carry out such a study - you have to ask yourself why.

I hope when reading this open letter to you, Dame Kelly, that you don't think that these instances above are just a few minor incidents and that Seroxat is actually a great drug.

I hope you don't think that this is just about one drug.

I hope you are aware of GlaxoSmithKline's recent $3 billion dollar fine in the US. A fine that they paid after pleading guilty to a host of violations, including the promotion of Seroxat to children. They blamed it on an 'era' at GlaxoSmithKline - That 'era' was when somebody else was in charge at GlaxoSmithKline. That 'era' continues today. Links at the foot of this post Kelly.

Do you still wish to be associated with GlaxoSmithKline Dame Kelly?

It would be refreshing if a high profile sports star and Dame actually spoke out against GlaxoSmithKline rather than work with and alongside them.

If you wish to know more then please feel free to contact me - Email on right hand sidebar.

Yours sincerely

Bob Fiddaman.

Seroxat Suicide

Sharise Gatchell RIP.

Mother Speaks Out [Seroxat Suicide]

Sara Carlin Inquest - We Know How, Now Tell us Why!

Birth Defects

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

GSK - Bribery and Fraud

No comments:

Please contact me if you would like a guest post considered for publication on my blog.