Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label narcolepsy. Show all posts
Showing posts with label narcolepsy. Show all posts

Friday, May 29, 2020

The GSK Covid Vaccine: Will We Be Safe?



Media reports suggest GSK, the British based pharmaceutical giant, are close to producing 1 billion doses of a coronavirus vaccine booster in 2021. Little is known about the ingredients of the vaccine, at least in the mainstream media.

GSK have merged with the French multinational pharmaceutical company, Sanofi.

Between them, GSK and Sanofi have paid out $5,063,939,512 in violation fines, GSK paying $4,422,266,058 (billion) whilst Sanofi come in at $641,673,454 (million)

GSK, who rolled out the Pandemrix vaccine for the last global pandemic, are set to make a pretty penny if they and Sanofi can get the coronavirus vaccine booster past the regulators - this process has been made easier for them due to global drug regulators giving drug companies a rapid path by allowing them to bypass animal testing.

Animal tests are a critical step in vaccine and drug development. Normally, a new vaccine can take anything between 5 to 20 years to develop before it can be made available to the public. Animal tests are carried out to determine safety and efficacy at preventing the disease in question. Regulators, such as the MHRA in the UK and the FDA in the US, usually require that a manufacturer shows a product is safe in animals before it goes into people. 

This from the European Medicines Agency:

"The regulatory workshop was held virtually on 18 March 2020 in the context of the ongoing COVID-19 pandemic. It brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally, as well as experts from the World Health Organization and the European Commission, to share their views on the development of vaccines against COVID-19. The meeting was co-chaired by EMA and the US Food and Drug Administration (FDA)."

The summary report of that meeting can be found here.

Pandemrix: The Swine Flu Vaccine

Research published in the BMJ in 2013 suggested a possible link between the swine flu vaccine given to children in the UK and Europe during the epidemic in 2009 and 2010 and a rare condition called narcolepsy, which causes people to fall asleep suddenly without any warning and at any time of the day.

A further report, also published in the BMJ in 2018, asked the question, 'Pandemrix vaccine: why was the public not told of early warning signs?'

In 2019, an Irish woman, Aoife Bennett, 27, who received the Pandemrix vaccine in school in 2009 as part of a state campaign against swine flu. sued the government after developing narcolepsy shortly after receiving GSK's Pandemrix. The case was settled for an undisclosed amount of compensation to the victim.

This from The Guardian:

"Bennett told RTE on Wednesday that she was active and athletic until being vaccinated in December 2009. About two weeks later the side-effects began, she said. “Things changed very drastically.” She felt “like a sloth” and became fatigued, disoriented and prone to collapse.

"She expressed dismay that it took seven years of legal proceedings to obtain compensation.

"The defendants in the case were GlaxoSmithKline Biologicals, the health service executive, the minister for health and the health products regulatory authority, formerly the Irish medicines board."

Further, in 2017, the UK high court rejected a British government appeal to withhold payments to dozens of British children who developed the sleeping disorder after swine flu vaccines. Six million people in Britain, and more across Europe, were given the Pandemrix vaccine made by GlaxoSmithKline during the 2009-10 swine flu pandemic, but the jab was withdrawn after doctors noticed a sharp rise in narcolepsy among those receiving it.

It all seems pretty clear then that GSK's Pandemrix vaccine caused narcolepsy in some who were administered it. A way to keep such news at bay is to make settlements with those who file lawsuits.

When we look into the Swine Flu pandemic, we can see similarities into what is panning out today in 2020. The same questions should be asked about the safety of any potential Covid-19 vaccine and we shouldn't have to wait until people suffer a severe adverse reaction to it as we did with the GSK's swine flu vaccine.

Incidentally, what do GSK have to say about their product, Pandemrix, causing narcolepsy? Well, only yesterday, in efforts to convince the public that there will be no problem with their new vaccine for Covid, they claimed its previous flu pandemic vaccine, (Pandemrix) which used some of the same ingredients as Covid-19 vaccines currently under development, was not linked to a rise in cases of the sleep disorder narcolepsy

This from RTE:

"A spokesman for GSK said the "science has moved on" since concerns were raised about links between narcolepsy and its H1N1 vaccine, called Pandemrix, which was developed during the flu pandemic 10 years ago. 

"He said evidence now suggests the link is to the H1N1 flu virus itself, not the vaccine. 

"In a statement to Reuters, the company said available scientific data suggest that "the rare occurrence of narcolepsy during the 2009/10 flu pandemic was triggered by the body confusing a protein in the wild type H1N1 flu virus with a human protein relevant in regulating the sleep cycle." 

In 2010, The Daily Mail, a British newspaper, reported on how Drug firms cashed in on scare over swine flu. Dr Wolfgang Wodarg, who at the time was head of health at the Council of Europe, branded the swine flu pandemic as 'one of the greatest medical scandals of the century.'

The 2010 Daily Mail article, which is like a version of Groundhog day playing out, also highlights how Sir Roy Anderson, a scientist who advised the UK Government on swine flu outbreak, held  a £116,000-a-year post on the board of GlaxoSmithKline.

One of the current Covid scientific advisers to the UK government, Patrick Vallance, is the former head of GlaxoSmithKline's vaccine division.

Déjà vu anyone?

Finally, although I cannot prove the authenticity of the claims in  a video that was recently uploaded to YouTube,  an independent journalist claims he has recently been contacted by a GSK whistleblower who  told him vaccines trialled out on women contained an antigen that was shown to cause a 97% increase in infertility. The antigen also allegedly makes men sterile.

The video has since been removed by YouTube but can still be accessed here.

Bob Fiddaman










Tuesday, January 22, 2013

GSK's Swine Flu Shot Linked to Sleep Disorder





Ring-a-ring o' roses,
A pocket full of posies,
Pandemrix! Pandemrix!
We all fall down

Narcolepsy:

Narcolepsy is a neurological disorder caused by the brain's inability to regulate sleep-wake cycles normally. The main features of narcolepsy are excessive daytime sleepiness and cataplexy. The disease is also often associated with sudden sleep attacks, insomnia, dream-like hallucinations, and a condition called sleep paralysis - National Sleep Foundation

Glaxo are in the news again... this time it's their vaccine Pandemrix that's making all the wrong sort of headlines for the British based drug giant.

Latest figures have shown that almost 800 children in Sweden who received the Pandemrix H1N1 swine flu vaccine have been left with the incurable sleep disorder, narcolepsy.

According to Fox News similar findings have been found in Finland, Norway, Ireland and France.

Faced with these alarming figures GSK's chief medical officer, Norman Begg, states, GSK views the issue extremely seriously and is "absolutely committed to getting to the bottom of this", adding, "there is not yet enough data or evidence to suggest a causal link."

Of course not, Norm.

I remember when Swine Flu made the news. There was a huge push, in the UK at least, for people to rush out and get vaccinated. I never really bought into it.

Back in 2009 Switzerland restricted the use of Glaxo's swine flu vaccine, they did so by excluding pregnant women, minors and people over the age of 60. Swissmedic, the Swiss medicines regulator, did not allow it to be used in children because they had "received very little information on it."

Also, in 2009, the German Professional Association of Environmental Medicine (Deutscher Berufsverband der Umweltmediziner – DBU) issued a press release regarding Glaxo's Pandemrix, part of which read:

"Pandemrix poses substantial health risk with respect to mass immunization programs due to the lack of proof of safety."

Back in 2010 I wrote about how Glaxo were under investigation for bribery in Finland. In short, the Chancellor of Justice was investigating if bribery was used in narcolepsy-suspect Pandemrix vaccine trade. The investigation was carried out because two individuals had reported their suspicions to the Chancellor. Investigation targeted the Ministry of Health and THL, National Instute for Health and Welfare. THL has received more than six million euros in 2009 from GlaxoSmithKline. THL has also had a key role in the decision to order Pandemrix to every Finnish inhabitant.

Meantime, the narcolepsy link continues to rear its ugly head in Sweden. Goran Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, has added much fuel to the fire. Speaking with Fox he told them, "This is a medical tragedy, hundreds of young people have had their lives almost destroyed."

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Fox News article HERE













Monday, December 12, 2011

GSK - Absolutely Jabulous



I wasn't going to write about this but with various emails and messages on social networks telling me about it I thought I'd better, at least, offer a small snapbyte for cyberspace.

Once again it would appear that GlaxoSmithKline are swimming that great river of Egypt [Denial ~ The Nile] with regard to their Pandemrix vaccine [flu-jab] and its link to narcolepsy, a sleep disorder that causes excessive sleepiness and frequent daytime sleep attacks.

Today's Mail Online is reporting that 6 year old Josh Hadfield is still suffering from the after effects of the controversial jab.

"I’m up with him around four times each night to feed him snacks and also comfort him because he has horrendous nightmares," she said. "He used to be sent home from school every time he fell asleep but now they have set aside an area in his classroom where he can take a nap."

Worringly, the Mail Online is reporting that young Josh is now taking the antipsychotic Ritalin and other antidepressants.

So, let's get this straight. A 6 year old is given a flu jab, he has an adverse reaction to it, a reaction that is so horrendous that he sleeps for most of the day, his school even allow him to take a nap. To combat this, young Josh is given a powerful antipsychotic and, according to the Mail Online, antidepressants, medication that has not been recommended for use in children.

Amazing isn't it. I don't know why they just don't stick young Josh in a glass box with a hamster wheel and some straw.

The story of Josh appeared in the Mail Online back in April this year, it's unknown if he was taking Ritalin and antidepressants back then.

GlaxoSmithKline's Dr Pim Kon, said: "There is currently no evidence at all to suggest there is a causal link between Pandemrix and narcolepsy." She added that GSK are working hard with the regulatory authorities to try to understand what is happening.

Dr Pim Kon is no stranger to controversy. Last year she told the InPharma magazine that European regulators [EMA] were wrong to withdraw its diabetes drug Avandia from the market. Avandia was suspended by the EMA last year because of high levels of heart attack, heart failure and strokes in patients.

I've briefly touched on Glaxo's Pandemrix Vaccine in the past on this blog.

Back in 2009 Switzerland medicine regulators, Swissmedic, restricted the use of Pandemrix because they had not recieved enough data about it. In a statement they announced, that they had received data on the vaccine for adults, but not for pregnant women and very little data for children. "For this reason, Swissmedic has not yet authorised the administration of Pandemrix to pregnant women, children under the age of 18 and adults over 60."


It's unclear whether or not Swissmedic later authorised the use of Pandemrix in children.

Also in 2009 The Environmental Illness Resource announced that Glaxo's Pandemrix vaccine was unsafe to use in those that had environmental illnesses. The full statement can be read HERE.

In 2010 I highlighted a story that had made the Finnish press. According to Nelonen (Channel 4) news, the Chancellor of Justice was investigating if bribery was used in the Pandemrix vaccine trade.

The Nelonen (Channel 4) news reported that the the investigation had begun because two individuals had reported their suspicions to the Chancellor. The investigation targeted the Ministry of Health and THL, National Instute for Health and Welfare. THL had received more than six million euros last year from GlaxoSmithKline, which manufactures Pandemrix. THL has also had a key role in the decision to order Pandemrix to every Finnish inhabitant.

Ironically, the study that now has Glaxo and the medicine health regulators in a tizz stems from Finland. In what seems to be a massive U-Turn, the Finnish government said it accepted a link between Pandemrix and narcolepsy and has promised compensation and support for affected families.

So, nothing to do with the 2010 expose then? I wonder whatever did come of that investigation?

A cynic, Moi?


Watch a special investigation into the Pandemrix/Narcoplepsy link on BBC IPlayer HERE

Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

**Correction: Ritalin is, of course an amphetamine and not an antipsychotic. [Thanks Judy for noticing the error]


Thursday, July 21, 2011

Glaxo's Pandemrix Vaccine Restricted Use Review



The European Medicines Agency [EMA] today issued a press release regarding GlaxoSmithKline's Pandemrix vaccine. It's more bad news for Glaxo as the EMA have decided to restrict its use in children and teenagers because of a link to narcolepsy.

Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by an excessive urge to sleep at inappropriate times and in Finnish and Swedish studies there was a 6- to 13-fold increase risk of narcolepsy in young people who had received the Pandemrix vaccine.

The EMA have recommended a labeling change that limits the vaccine's use in children and teens to when protection is needed and seasonal trivalent vaccine isn't available. In other words, it won't be used as a first line treatment.


GSK have issue a press release on their webpage, the end paragraph is classic:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Pardon the pun but...Zzzzzzzzzzzzz

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING


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