Incredible Footage Of Former GSK CEO – JP Garnier- Surfaces- On Fiddaman’s New Post -From The Stewart Dolin ‘Paxil Induced Suicide” Trial In The US…


Bob Fiddaman has been doing stellar reporting/blogging about the Stewart Dolin, “Paxil Induced Suicide” Trial in Chicago. He has just posted incredible footage of JP Garnier (the former GSK CEO – before Andrew Witty) discussing Paxil/Seroxat in a video deposition (May 2006). Garnier is his usual arrogant, creepy self, however, the deposition itself is incredible. It seems that GSK had a legal duty to warn about serious adverse affects, so why were they passing the buck to the FDA?

Paxil/Seroxat caused much harm, death and destruction to tens of thousands of people, however judging by Garnier’s attitude in this video deposition, he comes across like he couldn’t care less…

In fact, he looks bored..

I guess dead Paxil/Seroxat people are just boring issues to some pharma CEO’s..

What is the point in having a CEO, if they are never held accountable?

Disturbing…


Saturday, March 18, 2017

Dolin Vs GSK – JP Garnier Video Deposition

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I was going to take a break this weekend as I’m in Washington DC taking time out from a hectic week of traveling to and from the Chicago courthouse where GSK are claiming Paxil does not cause suicide in adults. Furthermore, GSK claims Paxil did not cause 57-year-old Stewart Dolin to end his life by jumping in front of a train. GSK’s argument is that Stewart Dolin had ‘work-related’ problems which caused him to jump. GSK claims the Paxil he was taking as prescribed had nothing to do with his akathisia-induced death.

Earlier this week three video depositions were aired to the jury, they featured former GSK CEO, JP Garnier, Former Glaxo Executive Jeffrey Dunbar and GSK biostatistician John Davies.

Much to my delight, the video depositions have now been released to the public – this is a unique move and one that makes me very happy indeed.

Today I’m going to focus on one of these three videos. It features former GSK CEO, JP Garnier. After watching the video you will hear audio that wasn’t aired in court. It, once again, features former Glaxo CEO, JP Garnier. It is audio that has been public for many years and, in the context of his video deposition, shows how Garnier had an opportunity to inform the public about Paxil’s suicide link but chose not to. He instead opted to hang-up the telephone live on air.

It’s important that you watch the video first then listen to the audio.

In the video, we hear JP Garnier answer questions about GSK’s responsibility to warn doctors and patients that Paxil can and does induce suicidality. In Dolin Vs GSK, King & Spalding (GSK’s defence team) have already told the jury during opening arguments that Paxil does not cause suicide in adults. Furthermore, they have claimed they told the FDA that, after reviewing Paxil data, they wished to change the drug labeling.  According to GSK, the FDA chose to use its own wording rather than using GSK’s. King & Spalding told the jury there was nothing else they could do regarding labeling. Garnier’s testimony, however, suggests that was a bold-faced lie.

The video deposition was taken in 2006.

“You can change your label without even getting approval from the FDA, there’s a law that allows you to do that, correct?”

Garnier answered, “Yes, but in practice, you don’t want to do that.”

He was then pressed, “Okay. But you can do it if you want, the law allows that to occur?”

Garnier replied, “Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let’s say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn’t like the way you did this, you have to redo it. So it’s considerably disrupting, that’s why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public.”

So, Glaxo’s own CEO claimed in 2006 that there was a legal right to inform the public about any serious adverse event–including the most serious of them all, suicide.

Now, let’s listen to an interview from Garnier taken in May 2008, some two years after he admitted (under oath) that he and his company had a legal obligation to inform the public about serious adverse events and that they did not have to go through the FDA to get this news out.

Garnier was being interviewed by BBC correspondent, James Naughtie, about a vaccine. However, Naughtie deviated from the subject of vaccines and chose to ask Garnier about Seroxat (known as Paxil in the US).  Garnier, when pressed, chose not to discuss. Now, didn’t he have a legal right to do so, as he claimed in his 2006 video deposition? Instead, Garnier chose to hang up the phone and end the interview.

(Hmm, so much for having a legal duty to inform the public.)

I’ll leave it up to you, the reader/listener, to decide whether or not you think Glaxo’s former CEO had ample opportunity to inform the public about Paxil’s serious adverse events.

Here’s that classic audio… the discussion of Paxil starts at the 3.24 mark.

Garnier was given a public platform to inform consumers about Paxil’s serious adverse events, remember, as a CEO, he had a legal right. Why then did he choose to end the conversation abruptly?

Just sayin’.

Over to you, Todd.

**COMING UP TOMORROW**

The video testimonies of former Glaxo Executive Jeffrey Dunbar and GSK Biostatistician John Davies.

Bob Fiddaman.
 
Related
 

 

More Damning Evidence About Seroxat/Paxil And Suicidality …


Brilliant reporting from Bob Fiddaman at the Stewart Dolin ‘Paxil Induced Suicide’ trial in the US.

More damning evidence that Paxil/Seroxat is a drug that simply should never have been on the market in the first place…


 

Friday, March 17, 2017

Dolin vs GSK – Healy ‘Rocks Da House’

This is complex, this is time consuming. Two days of evidence presented to the jury, judge and layperson (me included).

Cut through the endless amount of questions (they always lead to the truth where GSK are concerned) – and you will see, through Healy’s evidence, the reasons why this case is a “Slam Dunk” for Dolin et al and why GSK’s hot shot law team bounce up and down crying ‘objection’ at every given opportunity.

Objection! Because they don’t want the jury to know about their previous ghostwritten articles.

Objection! Because they don’t want the jury to know about GSK’s previous fine of $3billion (yes, that’s billion, fine for promoting Paxil off-label to kids.

Objection! Because they don’t want the jury to know about the Paxil withdrawal issue because, “it’s a case that is on-going against them in the UK) – Forget the case of Paxil withdrawal they’ve already settled with over 3,000 plaintiffs in the US, right?

Objection! Because they don’t want the jury to know they lied about the fact that Paxil was safe for kids.

They even objected to Wendy Dolin’s attorneys for wishing the jury had a great weekend, or words to that effect!

What I have witnessed here in Chicago is a law team representing an abhorrent company, the law team being made up of men and women (think about the birth defects Paxil has caused – I mean, their law team has a woman of child bearing years!)

Bayman (King & Spalding) also asked the Judge to reiterate to the jury that they should not “Google” about Paxil or the case in question. Yeah, right, Heaven forbid the jury stumble upon GSK’s abhorrent record and/or disregard for human life, right?

I honestly don’t know how a team with kids, siblings, wives, husbands or any other family members for that matter, can sit there and defend a drug (Paxil) that has caused so much heartache for families over the years. Are they devoid of any compassion, any empathy, any common sense?

My thoughts are, to some, irrelevant – Am I biased? Maybe? With a whole bunch of lawyers sitting on one side of a courtroom defending a drug that, probably, none of them have taken or, none of their loved ones have taken, I feel like I’m banging my head against a brick wall.

King & Spalding’s main two men, Andrew Baymen and Todd (snigger at a name that befits a child) Davis, seem devoid of any compassion and/or rationale – they don’t want to talk about ghostwritten articles, they don’t want to talk about the $3 billion dollar fine their defendant got for the illegal promotion of off-label practises of many drugs, including Paxil. They don’t want to talk about the withdrawal problems that Paxil can cause, and they don’t want to talk about how the company they are defending put children and adolescents at risk when they sent out their work force to promote the safety and efficacy of Paxil.

For these reasons, I am de-humanized from that table (in the courtroom) that represents this truly abhorrent company. A table of psychopaths or people who just want the right to pay their monthly bills? – Psychopaths is a pretty good description, given that they know, and have  known of Paxil’s severe side effects for many, many years.

Healy’s expert opinion leaves me wondering if the jury want/need to hear anything more. He told the jury how…

  • In 2006, the FDA knew about the increased suicidal risk on Paxil.
  • GSK reported that there was no risk f Paxil induced suicide in 1999.
  • GSK showed 6 suicide ttempts on placebo,when the actual figure was 1, in fact it was zero!
  • GSK claimed that Paxil did NOT cause suicide and this convinced prescribing Dr’s to prescribe Paxil.

Let’s just take a look at some evidence aired today…these are from GSK’s own internal documents. The public, or those who had or have been prescribed Paxil never got to hear about this…

– 50 year-old female patient who became suicidal on Paxil (GSK’s own admission, probable cause!)
– 55 year-old male patient who showed “unrest and agitation” – patient was put on Paxil for 3 days when problems began, Paxil was stopped – patient felt better.
– 59 year-old male – experienced ‘restlessness’, visual disturbances – Patient recovered one day after Paxil was removed!
– 32 year-old male, on day one of Paxil treatment, developed severe akathisia – patient was confused throughout study.

Healy reminded the jury that GSK’s stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) actually made, some people develop symptoms that it was, originally, meant to treat!

Many exhibits were aired that further showed how GSK hid the suicide link with Paxil. In fact, it was learned, GSK’s own re-analysis of Paxil (2006) showed an increase of 6.7 patients in Paxil adult patents. (the increase 6.7 times the greater likelihood one who takes Paxil will develop suicidality)

Oh, by the way, Stewart Dolin was 57.

Healy told the court that, based on his own clinical experience, Paxil was the most potent and problematic of all the SSRIs on the market. He also informed the jury that, as a clinician himself, he does not prescribe Paxil and added that the hospital where he works does not have Paxil on their list as a possible medication to treat a psychiatric illness.

To back up the evidence, the jury was shown an email to GSK’s marketing guru, Barry Brand. The email focused on Paxil’s suicide problem.

King & Spalding’s, Andrew Bayman, played his ‘Jack-in-the Box’ routine throughout the day. His sidekick, from King & Spalding, Todd Davis, remained in the wings being as quiet as a mouse – strange because it is “Todd” who has targeted the kids of Wendy Dolin leading up to this litigation. Is Todd married? Does Todd have a regular girlfriend/boyfriend? Does he have children of his own? Is his blinking affliction down to the overuse of a psychotropic medication? Who knows?

That’s poor show from me, I shouldn’t mock the afflicted…then again, these schmucks have defended the indefensible for years – they’ve shown no remorse when people have gone on to kill themselves whilst on Paxil – why would they when they are earning vast amounts of money (by the hour) defending GSK?

GSK are King & Spalding’s cash cow. They tried, through objection, to hide the truth about Paxil to the jury. They failed on a grand-scale.

Most damning, for today at least, was Healy’s claim that he is one of the only people to have read the ‘raw data’ regarding Paxil and suicide, raw data that leaves him firmly believing Paxil can induce suicidality in adults, something that GSK have, for years, denied.

Healy also spoke how GSK used the term ’emotional lability’ when reporting suspected suicidality in clinical trials, a term that would have made, even him, think there was no problem with Paxil. A term that would have made most prescribing doctors think that there was no suicide problem with Paxil!

Churlish.

GSK’s table of attorneys look slick. One aging bald-headed guy even approached the judge at the end of today’s proceedings to complain that Wendy Dolin’s law team had wished the jury a “nice weekend” as they were dismissed.

Objection, objection, objection.

They seem like a stuck record. A team of misfits whose only mission is to blame everything but Paxil opting, instead, to blame the patients for having an ‘underlying illness’.

The questioning of Healy by Dolin’s attorney’s finished today. He will be cross examined by King & Spalding on Monday.

I’ll be there. Stewart Dolin will be there in spirit.

More on the past two days events tomorrow night, in particular evidence that shows how a witness called for GSK in this trial showed how another unrelated drug caused two patients akathisia and they ‘jumped’ to their death.

Stewart Dolin (57)  ‘jumped’ in front of a train because Paxil caused psychosis and akathisia, an adverse drug reaction that is so horrible, death can be seen as a welcome alternative.

Bob Fiddaman.

Dolin back stories.

Bob Fiddaman Covers Day 2 Of The Dolin Paxil Induced Suicide Trial..


I don’t know  about you, but I have been fascinated by Bob Fiddaman’s coverage of the Stewart dolin Paxil induced suicide trial the last few days. His latest post uncovers some really damning material for GSK in regards to Paxil/Seroxat. It’s surprising that GSK chose to bring this case to court, surely even the dogs in the street know that GSK are nothing but an utterly reprehensible corrupt entity? and that close to NONE of their drugs can be trusted as efficacious or safe?

GSK are proven liars, felons, deceivers and fraudsters.

They lie about everything, particularly the data. They can’t be trusted. They have simply no credibility and they haven’t had a shred of it for years.

Paxil/Seroxat is particularly bad in terms of controversy because it’s utter poison.

The Seroxat Paxil scam has long been exposed, and the game has been up for a long time too.

These court cases reveal the carcass of a company- which has long been- rotten to the core.

Fair play to Fid for covering this compelling case.

I look forward to more revelations in the coming days ahead.


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-two-jack-in-box.html

Thursday, March 16, 2017

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

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Day two kicked off with King & Spalding’s Andrew Bayman finalizing his points to the jury that he started yesterday. He told them that, in 2006, GSK told the FDA about Paxil’s increased suicide risks, he also told them that ‘Dear Doctor’ letters were sent out across the United States and that Stewart Dolin’s doctor was aware of this. According to Bayman, the FDA changed GSK’s warnings for all SSRIs and not just Paxil. Bayman also claimed that the FDA had told them (GSK) 4 times that they could not use their own wording in the label warning. Bayman also told the jury that GSK’s sales force (reps) have no influence in prescribing habits – at this point I had to hold in my laughter, given that they paid a $3 billion fine recently to the DOJ for doing just that! (See – “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud.”)

More on King & Spalding’s Andrew Bayman later in this post.

Next up was Brent Wisner of Baum Hedlund who is representing Stewart Dolin’s, widow, Wendy Dolin.

Dolin presented the jury with three video depositions, the first being a May 2006 testimony from former GlaxoSmithKline CEO, JP Garnier. The depo was used in a previous case against GSK where Debra L. Tucker filed suit against them for the wrongful death of her brother, Rick, who, she alleged, killed himself after taking GSK’s Paxil.

In the 2006 testimony Garnier was asked…

“Would you agree that a reasonable and prudent pharmaceutical manufacturer has a duty to warn prescribers of serious adverse events?”

Garnier answered, “Yes, I would agree.”

It was also learned from Garnier’s deposition that there is a law in place to help pharmaceutical companies should they wish to change the labelling because of new evidence that may arise regarding serious adverse reactions. He was asked…

“You can change your label without even getting approval from the FDA, there’s a law that allows you to do that, correct?”

Garnier answered, “Yes, but in practice you don’t want to do that.”

He was then pressed, “Okay. But you can do it, if you want, the law allows that to occur?”

Garnier replied, “Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let’s say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn’t like the way you did this, you have to redo it. So it’s considerably disrupting, that’s why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public.”

The above 2006 statement from Garnier kind of contradicts what King & Spalding’s attorney, Andrew Bayman, told the jury earlier in the day.

The next video deposition aired in court today was from John Christian Davies, a statistician from GSK. He confirmed that 8 of the 11 suicide attempts that have been previously mentioned in this trial were aged 30 or below, leaving 3 that were over the age of 30. GSK, in the Dolin trial, are denying that Paxil can cause suicide in adults. Hard to believe that a bunch of highly paid attorneys would think that anyone over the age of 30 are children or adolescents.

The final video deposition to be aired today was that of Geoffrey Charles Dunbar. Dunbar gave his testimony in September 2005, again it was in relation to another Paxil wrongful death lawsuit.

In 1987 Dunbar joined GSK, who were then known in the UK as Beecham Pharmaceuticals. He was given the role of director of CNS, a role whereby he oversaw Paxil clinical trials. Paxil, at this stage, was still in its infancy and hadn’t yet come to market.

In the 2005 video deposition Dunbar was asked about the contentious two placebo suicides that were wash-out and run-in suicides (Back story). He said that he was not aware of them, he added that he had only recently become aware of them (bear in mind that the video deposition was taken in 2005).

Dunbar was then pressed further…

“Whether it was through oversight or negligence or intent or whatever the reason, that publication of published data was invalid, wasn’t it?” 

and

“Well, regardless of intent here, isn’t it true that public health on SSRIs for paroxetine was greatly misserved by your publications of this data in ’91 and ’92 and up through ’95 as being valid paroxetine figures not designated with an asterisk for wash-out and run-in? That was a misservice to public health, wasn’t it?”

Dunbar answered, “It was an error.”

Dunbar was then asked, “Okay. Are you inclined to do anything to correct the record, such as notifying GlaxoSmithKline that your authorship was incorrect?”

Dunbar answered that it wasn’t his intention to do so, on being asked why this was so? He answered…

“Because I think GlaxoSmithKline are very well aware of the issues we’re discussing now.”

Once the video depostions were played to those in attendance today, David Healy was then called to the witness stand…it was not without incident as King & Spalding made objections before Healy entered the courtroom, objections that saw King & Spalding attorney, Andrew Bayman, almost bursting a blood vessel as he tried to persuade the Judge not to allow certain lines of questioning from Baum Hedlund’s Brent Wisner.

The questions thrown at David Healy today, and his subsequent answers, will be covered in a blog post tomorrow. Suffice to say King & Spalding’s Andrew Bayman spent most of the day impersonating a Jack-In-The-Box as he stood from his seated position pleading objections to the Judge more times than I can count.

I personally think Bayman had an adverse reaction to the presence of Healy.

More on this tomorrow.

Bob Fiddaman.

Dolin back stories.

Another Legal Woe For Glaxo…


http://www.dailymail.co.uk/wires/ap/article-4313086/Couple-sue-pharma-giant-work-led-prison-China.html

Couple sue pharma giant for work that led to prison in China

LONDON (AP) – When investigators Peter Humphrey and Yu Yingzeng were hired by pharmaceutical company GlaxoSmithKline in 2013, their job was to look into a former employee in China who, they were told, was making false allegations about the firm.

The person, it turns out, was a whistleblower who had revealed GSK’s practice of bribes in China. And when Chinese authorities cracked down on GSK, they also swept up the husband-and-wife team of investigators, imprisoning them for two years for “illegally acquiring citizens’ information.”

Humphrey and Yu, back in Britain with health problems and in financial ruin, are now suing GSK for allegedly misleading them on what the job was about and exposing them to legal risks in China they could not have foreseen. GSK says there’s no merit to the claim.

Investigator Peter Humphrey poses for portraits at his home near Redhill, England, Tuesday, March 7, 2017. When investigators Peter Humphrey and Yu Yingzeng were hired by pharmaceutical company GlaxoSmithKline in 2013, their job was to look into a former employee in China who, they were told, was making false allegations about GSK. The employee, it turns out, was a whistleblower who had revealed a GSK practice of bribes in China. (AP Photo/Matt Dunham)

Investigator Peter Humphrey poses for portraits at his home near Redhill, England, Tuesday, March 7, 2017. When investigators Peter Humphrey and Yu Yingzeng were hired by pharmaceutical company GlaxoSmithKline in 2013, their job was to look into a former employee in China who, they were told, was making false allegations about GSK. The employee, it turns out, was a whistleblower who had revealed a GSK practice of bribes in China. (AP Photo/Matt Dunham)

The case sheds a light on how a small business became collateral damage in the fight between one of the world’s biggest pharma companies and Chinese state power.

“Peter was directly misled about what he was being hired to do,” says John Zach, the New York-based lawyer for Humphrey, 60, and Yu, 63. They are seeking unspecified damages from GSK, with Zach filing the latest response in the litigation this month.

The Chinese government’s investigation into GSK ended in 2014 with the company paying $490 million, China’s biggest ever corporate penalty, for bribing doctors and hospitals to promote its products.

The authorities also went after Humphrey and Yu, who were not covered by GSK’s legal defense and ultimately imprisoned for allegedly spying on a Chinese citizen.

The couple was paraded on Chinese television purportedly confessing their crimes. Jailed separately, they endured conditions that allegedly left them with serious health problems, including, in Humphrey’s case, prostate cancer he says went untreated during his incarceration.

“They knew I had a prostate problem but refused to investigate and treat it whenever I asked, telling me I must first sign a confession of crimes I hadn’t committed,” Humphrey said. He also developed a hernia, chronic arthritis and osteoporosis, aggravated by the lack of sunlight, fresh air, exercise and decent nutrition. Yu developed kidney disease.

Chinese authorities have denied accusations that the two were mistreated.

The couple were released in mid-2015 and deported to Britain. Humphrey was banned from China for 10 years; U.S. citizen Yu is unlikely to be granted a visa to return. In China, their company, which had 15 employees, went bankrupt, their property was seized, and bank accounts cancelled.

The lawsuit against GSK was lodged in November in Pennsylvania, where GSK’s U.S. operations are based.

GSK has asked the Pennsylvania court to dismiss Humphrey and Yu’s writ. In documents seen by AP, the company says there is no U.S. jurisdiction, as the couple’s company was hired in Shanghai by GSK’s China operation. They should take their claim back to China for arbitration, it says.

“We do not believe this case has any merit,” GSK said in a statement.

However it ends up, the case illustrates some of the legal risks small businesses can run into when deal with developing economies like China, as well as the difficulty of taking on a multinational with deep pockets. The lawsuit is not a big financial threat for GSK.

“They can ride out the scandals as the cost of doing business, and those who get caught up on the periphery are collateral damage,” said Tim Reed, executive director of Health Action International, a non-profit group representing consumer interests in drug policy.

Investigator Peter Humphrey poses for portraits at his home near Redhill, England, Tuesday, March 7, 2017. When investigators Peter Humphrey and Yu Yingzeng were hired by pharmaceutical company GlaxoSmithKline in 2013, their job was to look into a former employee in China who, they were told, was making false allegations about GSK. The employee, it turns out, was a whistleblower who had revealed a GSK practice of bribes in China. (AP Photo/Matt Dunham)

Investigator Peter Humphrey poses for portraits at his home near Redhill, England, Tuesday, March 7, 2017. When investigators Peter Humphrey and Yu Yingzeng were hired by pharmaceutical company GlaxoSmithKline in 2013, their job was to look into a former employee in China who, they were told, was making false allegations about GSK. The employee, it turns out, was a whistleblower who had revealed a GSK practice of bribes in China. (AP Photo/Matt Dunham)

GSK’s Cervarix Vaccine…


http://www.dailystar.co.uk/news/latest-news/593546/hpv-cervical-cancer-vaccine-teenager-dancer-paralysed-jab

Teen dancer left paralysed after HPV cervical cancer vaccine

A TEENAGE dancer has been left paralysed from the waist down after taking the HPV vaccine which helps to prevent cervical cancer.

Chloe Brookes-Holder and her mother SWNS

TRAGIC: A teen dancer has been left paralysed after taking the HPV vaccine

Chloe Brookes-Holder was once a healthy 12-year-old who danced six days a week when given the jab.

But now, six years on, the 18-year-old remains stranded in hospital, emaciated and paralysed.

Chloe, of Cheltenham, Gloucestershire, said: “At first, my family and I didn’t put two and two together.

Chloe Brookes-Holder on a hospital bed SWNS

PARALYSED: Chloe Brookes-Holder remains stranded in hospital

“Since getting sick from something the NHS gave me I don’t trust any medical professionals that I don’t know”

Chloe Brookes-Holder

“We thought the vaccine was safe because they give it in schools and on the letter the parents were given to sign consent I remember reading ‘it saves lives’.”

She said in the months that followed getting the injection at school, she fell ill with dizziness, headaches, fatigue and bone and joint pain – which left her muscles weakened.

She has now lost three stones, dropping to just 5st and is now being fed through a tube.

For years, doctors told Chloe the condition was in her head but now some believe the injection triggered an autoimmute response, causing her body to attack itself.

The teen said: “We trust our government to keep us safe but now, since getting sick from something the NHS gave me I don’t trust any medical professionals that I don’t know.

“Why? Because I’ve been treated in such a barbaric way. It’s been ill on earth.”

Chloe Brookes-Holder in hospital SWNS

STRANDED: The 18-year-old is left paralysed from the waist down

Shocking photos show her hooked to wires and drips, as she lies in a hospital – where she has been for the past 11 months.

Her mother, Sophie Brookes, 41, has been forced to give her job up as a hairdresser to become her full-time carer.

The 18-year-old is certain her symptoms are linked to the vaccine, which protects against the human papilloma virus and cause cervical caner – this kills around 900 women a year.

Chloe Brookes-Holder in hospital SWNS

VACCINE: She has now lost three stones and is being fed through a tube

She said: “I danced six days a week and loved to go to after-school sport and dance clubs every night. I was on the right road to getting A’s at GCSE.

“I wanted to have a dance career and my heart bleeds with the torture knowing I may never walk again and therefore ever dance again.”

Parents have called for more research into the jab, which has been a routine offered to 12 and 13-year-old girls since 2008.

Chloe became ill between her second and third injection of the Cervarix vaccine in late 2010 and the summer of 2011.

She came down with a string of viruses, started experiencing debilitating muscle pain and was diagnosed with fibromyalgia.

A gastrointestinal disorder left her in agony every time she ate or lost control of her bladder.

Chloe Brookes-Holder before she became paralysed SWNS

ONCE A UPON A TIME: Chloe was once a healthy 12-year-old

She was later diagnosed with Postural Orthostatic Tachycardia Syndrome which causes abnormal heart rate.

A year after having the injection, Chloe also began experiencing paralytic episodes and collapsing at school, unable to control her lower body.

She said: “I’m not scaremongering, I just care about others. This is real. This is the pure ugly truth. I want to make people aware so they can make decisions for themselves.”

Chloe Brookes-Holder in hospital SWNS

SHOCKING: Photos show her hooked to wires and drips

Cervarix was given to 6 million girls and while it is no longer offered to girls at school by the NHS, a new HPV vaccine, Gardasil is.

European Medicines Agency statistics show that up to January 2017, 3,683 reactions to Cervarix were reported and 11,802 to Gardasil.

Some 380 families, represented by the UK Association for Vaccine Injured Daughters, have called for more information in schools and research into potential side effects.

Medics have dismissed their concerns and NHS England insists that the jab is not dangerous, writing on its website that it is a “safe vaccine”.

Freda Burrell, of the UK Association for Vaccine Injured Daughters, said: “Many medical professionals will not link the vaccine to the girls’ health problems.

“Yet common sense should speak loudly if their medical records were excellent prior to the vaccine and their health changed dramatically after they had the jab.”

Chloe Brookes-Holder with her mother Sophie SWNS

LOVE: Her mum has been forced to give up her job to become her full-time carer

Public Health England and the Medicines and Healthcare products Regulatory Agency issued a joint statement in response to the claims.

They said: “As with all vaccines, the safety of the HPV vaccine is under constant review. Every report of a suspected side effect is taken seriously.”

“That there is no credible evidence of a link between the HPV vaccine and a range of chronic illnesses.”

They concluded: “The European Medicines Agency has also rued out a link to Postural Orthostatic Tachycardia Syndrome.”

2 Comments
2 Comments

11 days ago
SteveHinks
In 2008 the UK Government, assuming that the HPV vaccine to be capable of preventing cervical cancer (without any evidence to support it can prevent a single case of cancer), did an Impact Assessment using £1.7 billion as the cost of using HPV vaccine for the next 100 years. They also failed to consider any cost of adverse reactions! even though there were huge numbers during the clinical trials.

11 days ago
SteveHinks

There is ZERO evidence that Cervarix and Gardasil will ever prevent a single case of cancer. The manufacturers, GSK and Merck, only ever state they are ‘intended to’ or ‘expected to’ but it will be 20 years before we find out.

Cervarix is expected to prevent 2 strains of HPV, Gardasil 4 strains and Gardasil9 9 strains but there are over 170 strains of HPV with at least 40 involved in cancers but scientists expect other strains, potentially more lethal, to take the place of those which might be prevented by the vaccines.

The World Health Organisation has a database of adverse drug reports at vigiaccess.org. There are over 72,000 reports of adverse events with this vaccine, including 280 deaths, WHO also acknowledges only 10% get reported.

What is worse there have been several reports of VACCINATED girls as young as 18 developing cervical cancer.

Thank you Chloe for being so brave and helping to out the truth about this awful vaccine which is costing taxpayers hundreds of millions of pounds and filling our hospitals with severely disabled patients.

If you suspect your daughter, or son, have developed serious autoimmune diseases following vaccination please contact the UK Association of HPV Vaccine Injured Daughters (AHVID) for help


http://www.japantimes.co.jp/news/2017/02/13/national/crime-legal/suit-opens-tokyo-court-cervical-cancer-vaccine-side-effects/

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Suit opens in Tokyo court over cervical cancer vaccine side effects

by

Staff Writer

Twenty-eight girls and women suffering what they say are side effects from cervical cancer vaccines that were recommended by the government demanded compensation from the state and drugmakers Monday as their trial opened at the Tokyo District Court.

The plaintiffs, ranging in age from 15 to 22, said they have experienced a wide range of health problems, including pain all over their bodies and impaired mobility, after receiving the human papillomavirus (HPV) vaccines between 2010 and 2013.

Each is demanding ¥15 million in damages.

Erina Sonoda, a 20-year-old college student, said she started to suffer strong menstrual pain after receiving the second of three recommended shots of the Cervarix vaccine, and the pain spread to other parts of her body after the third vaccination.

Due to agonizing pain, Sonoda said she has difficulty walking without a cane and often must use a wheelchair.

“I felt acute pain as if someone was squashing my internal organs. … Such conditions have only gotten worse,” Sonoda told the court while sitting in a wheelchair.

“I received the shots because the government recommended it,” she said. “I want the government to take seriously its responsibility for causing us (to suffer from) such symptoms.”

Since last July, a total of 119 plaintiffs have filed similar suits with courts in Tokyo, Nagoya, Osaka and Fukuoka, according to Masumi Minaguchi, a lawyer representing the women.

The government and the drugmakers — GlaxoSmithKline PLC and Merck Sharp & Dohme Corp., who make the HPV vaccines Cervarix and Gardasil, respectively — sought Monday to dismiss the compensation claims.

Representatives of the drugmakers said the safety and effectiveness of the medicines against cervical cancer have been scientifically confirmed and denied there is any link between the alleged side effects and the vaccines.

The Health, Labor and Welfare Ministry began recommending in April 2013 that girls between 12 and 16 be vaccinated for cervical cancer. But the ministry halted the recommendation two months later following reports of side effects.

According to the ministry, 2,945 people out of the 3.39 million women who had received the shots by the end of last April have reported side effects.

A causal link between the HPV vaccines and reported symptoms remains unclear, and no scientific proof has been submitted.

A nationwide survey conducted by a health ministry research team between July and December 2015 found symptoms claimed as side effects of cervical cancer vaccines in both vaccinated and unvaccinated populations.

The team is conducting further detailed analysis of the data.

Cervical cancer is the second most common cause of cancer deaths in women under 40. Each year about 10,000 women develop the disease in Japan and around 2,900 die annually, according to the National Cancer Center.

The primary cause of cervical cancer is human papillomavirus, a common infection transmitted through sexual intercourse. The cervical cancer vaccines are believed to help prevent HPV.

In December 2015, the World Health Organization issued a statement criticizing the government’s decision to cease recommending the vaccine, saying that “policy decisions based on weak evidence, leading to lack of use of safe and effective vaccines, can result in real harm.”

Glaxo Have Been Bullshitting The Public (Us, And The Regulators, And Doctors) About Side Effects Of Their Drugs For (At Least) 30 Years…


From the New York Times 1984:



http://www.nytimes.com/1984/12/14/us/drug-maker-pleads-guilty-over-lethal-side-effects.html

DRUG MAKER PLEADS GUILTY OVER LETHAL SIDE EFFECTS

ALLENTOWN, Pa., Dec. 13— The SmithKline Beckman Corporation has pleaded guilty and two of its medical officials have pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug Selacryn.

In June the Philadelphia-based pharmaceutical giant and the three officers were charged with 14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage.

Doctors across the country have reported 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.

Two top officials of SmithKline’s medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest Wednesday in Federal District Court here to 14 counts of failing to file reports. The Government indicated it would drop charges against a fourth company official, Dr. Thomas G. Davis. Company’s Guilty Plea

The company pleaded guilty to all 34 charges filed this summer.

Judge Edward Cahn, who heard the pleas at a two-hour hearing, set no date for sentencing.

J. Peter Smith, an assistant United States attorney, said part of the plea- bargain agreement was that the Government would make no recommendation on sentences.

Donald J. Goldberg, Dr. Selby’s attorney, said the individual defendants would withdraw no-contest pleas and go to trial if Judge Cahn decided their sentences would include jail time.

SmithKline faces up to $34,000 in fines, and the individual doctors could receive up to 14 years in jail and $14,000 in fines. But Judge Cahn said community service could be part of whatever sentence he would impose.

The defendants were charged with failure to report to the drug agency within 15 days any unusual adverse effects of a drug.

Selacryn was developed 15 years ago by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.

Drug Won Quick ApprovalThe drug was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency’s approval of new drugs follows clinical tests on up to 1,500 patients. But in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.

That same month, SmithKline and the three physician-defendants received reports from Anphar Laboratories that Selacryn had damaged patients’ livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.

The information was never reported to the drug agency but ”dropped through the cracks,” Mr. Goldberg told Judge Cahn Wednesday. ”There was a very human error here, and there was damage that resulted from it.”

The company and the drug agency removed Selacryn, which was sold from May 1979 to January 1980, from the market after the Federal agency learned of deaths among its users.

Jeremy Heymsfeld, a SmithKline spokesman in Philadelphia, said the company was now involved in 13 outstanding lawsuits involving the drug and had settled numerous other legal cases.

Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, founded by Ralph Nader, said SmithKline had already paid $100,000 to $500,000 in out-of-court settlements in numerous cases.


http://articles.chicagotribune.com/1985-01-06/news/8501010952_1_smithkline-fda-selacryn

Drug`s Deadly Side Effects Spark Whodunit

By Tim Weiner, Knight-ridder Newspapers. A

January 06, 1985

ALLENTOWN, PA. — In August, 1979, Dr. Mervyn Lakin of Phoenix, Ariz., fell ill with an inflamed liver, jaundice, chills, a high fever–the classic symptoms of hepatitis. The 45-year-old internist suspected that a prescription drug he was taking was harming him.

Selacryn went on sale across the country on May 2, 1979, after winning approval of the U.S. Food and Drug Administration in near-record time. The drug`s manufacturer, SmithKline Beckman Corp., had high hopes for its new anti-hypertension drug. The company predicted that Selacryn would benefit millions of people suffering from high blood pressure and would produce annual sales of up to $80 million.

But in the eight months it was on the market, Selacryn was linked to at least 36 deaths and more than 500 serious injuries. It created one of the worst pharmaceutical disasters in recent American history.

It was to become the smoking gun in a medical detective story, reconstructed through court documents, testimony and interviews. On Dec. 12, after a 4 1/2-year federal investigation, the story`s penultimate chapter was written in the criminal convictions of SmithKline and three physicians it employed. No sentencing date has been set.

TO SMITHKLINE spokesman Jeremy Heymsfeld, there was a kind of vindication in the case. “After an exhaustive investigation of more than four years, there was no finding that the company acted intentionally, recklessly or for any commercial motive,“ he said.

To Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, a public-interest advocacy organization in Washington, it was a corporate crime with a meaningless penalty.

“For a company with 1983 profits of $490 million, a $34,000 penalty is a cruel joke,“ he said. That is the maximum fine that can be levied against SmithKline under the law.

Lawrence McDade, an attorney with the U.S. Justice Department`s office of consumer litigation, said the investigation took place in “an extremely sensitive area–the monitoring of prescription pharmaceuticals. There is a very real risk to the public,“ he said.

“We attempted to establish that individuals would be held personally liable for personal negligence in this area. It is obviously not sufficient for the corporation to plead guilty. Bringing an action versus an individual has a deterrent effect.“

FOR McDADE AND the other federal regulators and lawyers who pursued the case, a tortuous route led to the federal courtroom in Allentown, Pa., where SmithKline pleaded guilty.

In June, 1981, 18 months after the drug was taken off the market, the FDA recommended criminal prosecution of SmithKline. Half a million documents were subpoenaed from the company in the course of the FDA probe and a subsequent two-year federal grand jury investigation.

Earlier this year, Justice Department officials and FDA attorneys agreed that they would not attempt to press felony charges alleging criminal intent on the part of the company and its doctors. Instead, last June, federal prosecutors filed 34 criminal misdemeanor charges against them. Each count is punishable by up to one year in prison and a $1,000 fine.

Under the misdemeanor statutes, the government was required to show only that SmithKline and its doctors had the power to prevent the illegal acts from occurring and failed to do so.

The decision followed heated debate about the proper course to follow, according to persons close to the investigation. If the prosecutors believed there had been criminal intent on the part of the company and the doctors, that could have resulted in felony charges with more stringent penalties, up to three years in prison and $10,000 fines on each count.

BUT THE PATH chosen by the Justice Department led the company to end the lengthy process with a guilty plea, “to get the thing over with and not have it drag on for a couple more years,“ according to an attorney close to the case.

The case ended with the company pleading guilty and the physicians pleading no contest to 14 counts of violating FDA regulations by failing to file timely reports of the information SmithKline had on liver damage and deaths caused by Selacryn.

The company also pleaded guilty to 20 counts of falsely labeling Selacryn with an inaccurate and misleading statement that there was no cause-and-effect relationship between the drug and liver damage.

More than five years ago, Lakin, the Phoenix internist, felt sure that there was such a relationship. In an interview, he said he had placed an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline, which is base

Glaxo In Court Again… This Time Over Myodil…


Myodil is a truly scandalous and horrific GSK product…


http://www.lexology.com/library/detail.aspx?g=676e9823-1d6b-4912-b733-d5e8b10c088d

Date of knowledge and Limitation – Lewin v Glaxo – Case Report
Blog piBlawg

United Kingdom January 18 2017

In cases concerning an allegation of bodily injury, time for the purposes of statutory limitation does not begin to run until the cause of action accrues or the date of knowledge of the alleged victim. The latter may be some months or years after the effluxion of the usual three year limitation period from the accrual of the cause of action. However it is rarely decades as it was in a recent case in the Queen’s Bench Division. In common with much of the extensive corpus of authority as to limitation, Keith Malcolm Lewin v Glaxo Operations Uk Ltd (Sued As Glaxosmithkline Unltd) [2016] EWHC 3331 (QB), turns on its own facts. It is however worthy of summary.

Here, upon hearing the trial of a preliminary issue on the subject, Mr Justice Goss found that the claimant’s claim was not statute-barred despite the claimant making complaint of treatment he received as long ago as 1973.

Some 44 years ago, the claimant underwent a diagnostic procedure during which Mydil was injected into his spine. It was held that the claimant’s date of knowledge arose when he was diagnosed as late as 2015 as suffering from post-Myodil adhesive arachnoiditis.

In the five or so years following the 1973 procedure, the claimant experienced persisting problems in his lumbar and cervical spine. This was investigated further in 1977 when it was considered that whilst the claimant may have had adhesive arachnoiditis, it could not be confirmed and further x-rays were unnecessary. The claimant’s problems continued during the 1990s, but it was not until 2007 when he developed severe left knee pain and thereafter other symptoms. An MRI scan in 20112 showed adhesions to his thoracic spine and the potential link between Myodil and the claimant’s condition was discussed. He underwent surgery in 2013, but it was not until March 2015 when a neurosurgeon concluded that the claimant suffered from post-Myodil adhesive arachnoiditis.

The claimant issued proceedings in October 2015 against the background of the fact that in the early 1990s group litigation had been pursued against the defendant in respect of Myodil in which settlements were agreed without any admission of liability. Over 4000 individuals had notified claims although, in the event, only 426 claims were proceeded with.

The Court was asked to determine the date upon which the claimant’s cause of action accrued; his knowledge for the purposes of section 14 of the Limitation Act 1980; and if the claim was statute-barred, whether the court’s discretion pursuant to section 33 of the same Act should be applied.

The court held that the cause of action accrued when the Myodil caused injury to the claimant, not the date it was injected. On the facts of this case this occurred around 2007.

The defendant argued that by the 1980s the claimant had constructive knowledge sufficient to commence time running (per section 14(3) of the 1980 Act): he knew by 1977 he had a serious back injury and that the possibility of arachnoidiis had been raised sufficient to prompt him to investigate. The claimant argued that no clear cause for his symptoms had been determined. This found favour with the Court which further held that even had the claimant drawn a link, it was not reasonable to have expected him to have investigated it further. It was held therefore that the claimant’s date of knowledge was when the neurosurgeon’s diagnosis in 2015.

Goss J went on to consider whether he would have allowed an extension of limitation in any event. He held that he would have done had it have been necessary on the grounds that the claimant had sustained a very serious injury and the main prejudice to the defendant would have been financial as the matters complained of had already been investigated.

Glaxo’s Dirty Tricks At The Dolin Trial..


Good analysis of the current state of play at the Dolin Paxil suicide trial which began yesterday. GSK, of course, deny that Paxil played a part in Stewart Dolin’s suicide. Remarkable really, considering that Paxil/Seroxat is possibly the most controversial drug ,in relation to suicide, of recent times. GSK have been getting away with blaming the victim in various instances because Paxil/Seroxat is almost always prescribed to vulnerable people, so it’s easy for them to blame the individual and not the effects of the drug. Seroxat/Paxil definitely made me extremely suicidal, and I know it did to many others too.

From Fiddaman:

 http://fiddaman.blogspot.ie/2017/03/dolin-v-gsk-opening-arguments.html

Wednesday, March 15, 2017

Dolin v GSK – Opening Arguments

Day one of Dolin v GSK is over and, as expected, GSK are, it appears, trying to muddy the name of the victim, Stewart Dolin.

David E. Rapoport opened the arguments on behalf of Stewart Dolin’s widow, Wendy. He explained to them how, in 1989, GSK submitted  its “Integrated Summary of Safety Information” to seek approval of Paxil for adult depression. He also explained to the jury how the submission conveniently hid the link to Paxil being responsible for inducing suicide and suicidal thinking in patients during the clinical trials. (Back story) Rapoport also told the jury about Stewart’s life and how he had, in the past, been prescribed Paxil and Sertraline (Zoloft).

GSK made several objections, one of which was the objection to Rapoport’s use of the word “Paxil” – Part of GSK’s defence is that Stewart took a generic version of Paxil made by Mylan, ergo they are not responsible for his Paxil induced suicide – I say “Paxil” because whoever manufactured it after the patent ran out did so using GSK’s brand, a brand that became a household name. Stewart’s prescribing doctor even referred to it as Paxil. It was a churlish objection from GSK and one that, I think, will have little or no bearing on the outcome of this trial.

All in all, Rapoport spoke for around two hours, after which the Judge called for a 15 minute recess.

Next up was GSK, represented, in part by Andrew Bayman of King & Spalding, and, as expected, they were slick and focused on Stewart Dolin’s mental state at the time of his death. They tried to state that Stewart Dolin had work related problems which caused his “suicide”. Interestingly, they also claimed that Paxil does not cause suicide. So, effectively, every single person that has died by suicide whilst on Paxil did not die by suicide because of Paxil. Hard to believe given the amount of men, women and children that have died by violent suicide whilst taking Paxil.

**Correction**
GSK was represented by Andrew Bayman of King & Spalding and not Dentons as previously stated.

The fact that Paxil has a black-box warning was brushed over by GSK who claimed that the black box warning was put in place for all SSRIs and was meant as a red flag for prescribing physicians to monitor their patients.

GSK’s lawyer told the jury that he intended to speak for just an hour, an attempt at point-scoring exercise if ever I’ve seen one. However, approaching the hour the Judge intervened and told him his hour was almost up. He responded by saying he just needed to summarize which he plans to do do tomorrow morning.

Opening arguments is basically two parties setting out their stall. It was pretty obvious that GSK would go down this route (blame the victim). During the lead-up to this trial they have targeted Stewart’s widow, children, friends and expert witnesses.

Tomorrow morning they will no doubt reiterate their “blame-the-victim mantra” they tried to sell today. It’s the only defence they seem to have.

Bob Fiddaman.

Dolin Back Stories

Paxil/Seroxat Suicide … How GSK Hid The Link… (From Fiddaman)


http://fiddaman.blogspot.ie/2017/03/paxil-suicide-way-gsk-hid-link.html

Tuesday, March 14, 2017

Paxil Suicide – The Way GSK Hid the Link

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It’s the morning of the trial. The jury will shortly be sworn in.

The crux of the matter in Dolin Vs GSK is whether or not Paxil caused Stewart Dolin to kill himself whilst under Paxil’s influence.

Dolin’s widow, Wendy, intends to show the jury details of GSK’s prior knowledge of the Paxil suicide link. Furthermore, how GSK hid this link with skullduggery; ie; they carried out underhanded and unscrupulous behavior to keep the truth from healthcare professionals, regulators and, more importantly, patients.

In 1989, GSK submitted its “Integrated Summary of Safety Information” to obtain approval of Paxil to treat adult depression. Amongst other adverse event statistics, the Safety Summary reported the number of suicides and suicide attempts experienced by patients who took Paxil, a placebo or a comparator drug during GSK’s initial clinical trials.

In GSK’s presentation they compared the suicide attempts with patients in the Paxil group and those patients in the placebo group; and here’s how they hid the fact that more patients in the Paxil group had a far higher (significant number) of suicides and suicide attempts.

During the run-in period (which is also called wash-out), patients taking part in a clinical trial are taken off of any medications they may be taking and given a placebo (commonly known as a dummy or sugar pill) instead. In this way, a person’s system is “washed out” of other drugs and all patients start the trial on a drug-free basis at “baseline,” i.e. at the actual beginning of the clinical trial.

Because people who are stopping medications during this wash-out period may experience adverse events associated with withdrawing from the medication they were on, adverse events experienced during this period are not properly counted as occurring during the clinical trial. Adverse events that occur during run-in periods cannot be included when calculating adverse event ratios for clinical trials. This is standard practise for clinical trials.

The FDA’s Dr. Martin Brecher had mentioned in testimony that it is “scientifically illegitimate” to count placebo run-in/washout events. Furthermore, Michael Seika, another FDA medical reviewer, explained why run-in adverse events should not be counted. According to a December 8, 1999 GSK memo of a conversation with the FDA:

Specifically, I [Thomas Kline, Assistant Director of Regulatory Affairs at GSK] asked [Michael Seika] if a patient were to die during placebo run-in, i.e. prior to randomization, should that patient be included in the calculation for placebo deaths. He clearly stated that such a patient should not be counted in our analyses, since such a patient would not comprise the “controlled” portion of a trial.

Despite GSK knowing that counting adverse events during placebo run-in was improper they included them in their 1989  “Integrated Summary of Safety Information”

When the 1989  “Integrated Summary of Safety Information” is properly dissected we see that patients taking Paxil were at an 8.9 times greater risk of experiencing a suicide event than those on placebo.

GSK knew this but, by including the count for the placebo run-in/washout events, they were able to hide the risk of suicide from the FDA and, subsequently, prescribing doctors and patients.

By increasing the number of suicide attempts of patients taking placebo and reducing the number of Paxil patients attempting suicide, the percentages between Paxil and placebo became approximately the same – ergo Paxil patients had an equal chance of feeling suicidal if they had taken placebo. Because of this, the percentage of Paxil patients attempting suicide went down from the original submission because GSK reduced the number of Paxil suicide attempts from 42 to 40.

So, by removing the run-in suicide attempt events, Glaxo hid the fact that the correct number was 40 suicide attempts while on Paxil versus 1 attempt on placebo, an approximately 7.5 fold increase of suicide attempt risk for Paxil patients.

Paxil was approved by the FDA in 1992. The approval was based on GSK’s false placebo numbers and the incorrect conclusions based on them.

Additionally, once Paxil was approved by the FDA, GSK then went out en masse via a massive promotional campaign touting Paxil as safe and effective, they did this by using the false placebo numbers.

A year prior to Paxil’s official launch GSK’s (then SmithKline Beecham)  Dr. Geoffrey Dunbar and Sarah Mewett presented a paper entitled ‘Evaluation of Suicidal Thoughts and Acts with Paroxetine’ at a medical conference, in order to address the then-recent concerns linking suicidality to SSRI antidepressants. In their presentations they claimed that “Suicides and suicide attempts occurred less frequently with Paxil than with either placebo or active controls – they made this claim using the false placebo numbers.

Furthermore, in 1995 GSK’s Dunbar, along with two psychiatrists, submitted an article in the Medical Journal of European Neuropsychopharmacology. The article was published and claimed that Paxil actually reduced suicides and suicides attempts.

With this peer reviewed article in place GSK then instructed its saleforce team (reps) to play down the suicide risk associated with Paxil – (at the time reports via the media were suggesting there was a connection between Paxil and suicide)

GSK made billions of dollars from Paxil knowing that the data they submitted was false, meantime, patients on Paxil were feeling suicidal, many were completing suicide.

However, this wasn’t enough for GSK.

On April 11, 2002, GSK submitted a Supplemental New Drug Application (“sNDA”) to FDA proposing the use of Paxil to treat children and adolescents with major depressive disorder and obsessive compulsive disorder. During its review of GSK’s application the FDA’s  Dr. Andrew Mosholder  noted that the most prominent adverse reactions in the Paxil clinical trials were “behavioral effects,” but he stated “these events were coded with terms such as hostility and emotional lability.

In other words, GSK, once again, strove to hide the suicide link in Paxil – remember, this application was for children! The actual figures showed that Paxil demonstrated a relative risk 3.0 times greater than placebo.

If you don’t know the answer to why they hid the suicide information in both adult and children’s Paxil clinical trials, then you probably don’t know how business works. GSK hid the risks in both; they made lots of money from Paxil by getting it prescribed to adults, they wanted to do the same in the children’s market – but the FDA and British drug regulatory agency never granted it a license for use in children. It was, however, still prescribed to children – once again on the back of GSK’s salesforce team convincing doctors that it was safe and effective – they did this by showing prescribing doctors articles by prominent pediatric psychiatrists. What they didn’t show the prescribing doctors was that the published material they were showing them was ghost-written by a PR company hired by GSK – prominent child psychiatrists merely put their names to the published material.

This, ladies and gentlemen, is how GSK operate. This is how they were able to hide the suicide link. This is how they have made billions of dollars off the back of Paxil. This is why Stewart Dolin killed himself.

I’m off to the courthouse. Will blog about days events later.

Dolin Back Stories.

Bob Fiddaman.

 

2,051 children from state-run homes were used as medical guinea pigs for the pharma giant Burroughs Wellcome (Now Part Of GSK) during the 1930s.


A spokesman for GSK – formerly Wellcome – told the Irish Daily Mail: “The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.”

I wonder would Emma Walmsley or Andrew Witty like to make a statement about this?

 


The horrors of Mother and Baby Homes. Children sit in a tea room with a nun posing for a photo.

The horrors of Mother and Baby Homes. Children sit in a tea room with a nun posing for a photo.Adoption Rights Alliance

At least 6,000 Irish children died in the now notorious mother and baby homes throughout Ireland, but the nightmare doesn’t end there. Eighteen children, mostly girls, mostly mentally handicapped, were starved to death.

Details are emerging of the horrific stories behind some of the 796 deaths at the Tuam mother and baby home.

Irish leader Enda Kenny made an impassioned speech in the parliament yesterday calling Tuam a “Chamber of Horrors.”

He stated. “No nuns broke into our homes to kidnap our children.

“We gave them up to what we convinced ourselves was the nuns’ care.

“We took their babies (unmarried mothers) and gifted them, sold them, trafficked them, starved them, neglected them or denied them to the point of their disappearance from our hearts, our sight, our country and, in the case of Tuam and possibly other places, from life itself.”

Twelve of the 18 who starved were girls and there is a suspicion that some were mentally retarded. Bridget Agatha Kenny was two months old when she died as a result of marasmus, child malnutrition, on August 23, 1947. She is described as having been ‘mentally defective.’

She was one of 18 children whose cause of death was listed as child malnutrition or the official term “marasmus.”

Marasmus is a form of severe malnutrition characterized by energy deficiency. A child with marasmus looks utterly emaciated with ribs protruding. Body weight is reduced to less than 60% of the normal body weight for the age.

The new details raise the shocking specter of children dying of starvation in Ireland 100 years after the Famine.

Children in a playroom at a Mother and Baby Home   (Via: Adoption Rights Alliance).

Children in a playroom at a Mother and Baby Home (Via: Adoption Rights Alliance).

In 2014 it was revealed in a report compiled by Michael Dwyer of Cork University’s School of History 2,051 children from state-run homes were used as medical guinea pigs for the pharma giant Burroughs Wellcome during the 1930s. He came to this conclusion after trawling through tens of thousands of medical journal articles and archived files.

Dwyer told the Daily Mail in 2014, “What I have found is just the tip of a very large and submerged iceberg.

“The fact that no record of these trials can be found in the files relating to the Department of Local Government and Public Health, the Municipal Health Reports relating to Cork and Dublin, or the Wellcome Archives in London, suggests that vaccine trials would not have been acceptable to government, municipal authorities, or the general public.

“However, the fact that reports of these trials were published in the most prestigious medical journals suggests that this type of human experimentation was largely accepted by medical practitioners and facilitated by authorities in charge of children’s residential institutions.”

Children taking the air, accompanied by nuns at a Mother and Baby home (Via: Adoption Rights Alliance)

Children taking the air, accompanied by nuns at a Mother and Baby home (Via: Adoption Rights Alliance)

There were nine homes in all and it is now also a confirmed fact that between 1940 and 1965 Saint Patrick’s, on the Navan Road in Dublin, and its sister hospital, Saint Kevin’s, “donated” the bodies of at least 461 deceased babies for routine dissection practice in all the major medical teaching institutions in the state, including Trinity College Dublin, The College of Surgeons and University College Dublin’s medical school.

No questions were asked where the baby bodies came from.

Following the excavation of “significant quantities of infants’ remains” at the Tuam site of the Bon Secours’ Mother and Baby Home the case has been handed over to the gardai (police). The case of the mass grave, homed in two underground sewerage structures, was referred to the north Galway coroner by the Mother and Baby Home Commission of Investigation.

As more widespread investigations into burial plots and Mother and Baby Home records across Ireland are called for the Coalition of Mother And Baby home Survivors released a statement, a rundown of facts already known about the Catholic Church’s Mother and Baby Homes. Among them is the fact that the children in the church’s care were used for medical experimentation and drug trials.

In 2011, RTE’s investigative current affairs show, “Prime Time” revealed that hundreds of the bodies of babies born in Ireland’s Mother and Baby were sent from the homes to Irish medical colleges. They also reported that other children were vaccinated in the homes with experimental drugs and closely monitored for side effects.

According to Dwyer’s report from 2014, no consent was ever sought by the Mother and Baby Homes for these medical procedures. These vaccine trials were carried out on Irish babies before the drugs were eventually made available for commercial use in the United Kingdom.

Nun sits with young boy and other children at a Mother and Baby Home. (Via: Adoption Rights Alliance)

Nun sits with young boy and other children at a Mother and Baby Home. (Via: Adoption Rights Alliance)

Among those homes listed were Bessborough, in County Cork, and Sean Ross Abbey in Roscrea, County Tipperary. Both of these homes are included among the mass grave investigations being sought by survivors and campaigners.

The report states that other institutions where children may also have been vaccinated include Cork orphanages St Joseph’s Industrial School for Boys, run by the Presentation Brothers, and St Finbarr’s Industrial School for Girls, run by the Sisters of the Good Shepherd. Dublin trials may have involved children from St Vincent’s Industrial School, Goldenbridge, St Joseph’s School for Deaf Boys, Cabra, and St Saviour’s Dominican Orphanage.

A spokesman for GSK – formerly Wellcome – told the Irish Daily Mail: “The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.”

Children at the Bon Secour Mother and Baby Home, in Tuam, County Galway.

Children at the Bon Secour Mother and Baby Home, in Tuam, County Galway.

At the time of the report Ireland’s Taoiseach (Prime Minister) Enda Kenny called for a countrywide investigation into these practices and the burial plots at Tuam, and other Mother and Baby Homes.

According to the 2011 “Prime Time” documentary, the Polio vaccine was developed during the 1950s. While this led to a decrease in such diseases as diphtheria, tetanus, and whooping cough, however this new drug brought on an increase in the amount of child research performed. Much of the research was consequently performed in children’s institutions through the 1960s. There are no records that show consent from the mothers in the homes. “It was clear from the report that there was no parental consent,” reports the documentary. “There was a violation of the physical integrity of the children.”

Before Dwyer’s 2012 report, a damning report by the Irish government’s Health Service Executive (HSE) found that the Irish Catholic mother and child homes had an infant mortality rate of 68% in 1943. The report shows that, according to the Register of Deaths, Bessborough Mother and Baby home during certain months in the 1940s the death rate among children living in the home amounted to a child dying roughly every second day.

More than 80 of the 472 infant deaths have malnutrition listed as the cause of death.

The reports also showed that as time went on, the standard of the death records kept decreased dramatically. It is the case that for hundreds of children listed it was unclear when exactly the death took place and it appeared that many were recorded at the same time.

 

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