Zantac Lawsuit


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

Thursday, November 11, 2021

Pfizer Double-Down With Children Promo and Accusations



On Nov 1, Pfizer published a video featuring children on their Twitter page. The video (below) shows children who are thanking all the children who enrolled in Pfizer's COVID-19 vaccine clinical trial, the results of which saw authorisation given by the FDA, despite protestations from safety consumer groups. It's unknown if the children who appear in the short video are child actors.

In the main, the reaction to the video was one of discontent from members of the public. One commentator wrote, "This is one the sickest things I’ve seen in a long time … but from the most fined company in human history I guess I shouldn’t expect any better."

I, myself, drew attention to Pfizer's past history regarding children, in particular a trial carried out in Africa in 1996.

This from The Guardian Aug 2011 

"Pfizer was sued after 11 children died in a clinical trial when the northern state of Kano was hit by Africa's worst ever meningitis epidemic in 1996. A hundred children were given an experimental oral antibiotic called Trovan, while a further hundred received ceftriaxone, the "gold-standard" treatment of modern medicine.

"Five children died on Trovan and six on ceftriaxone. But later it was claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children and questions were raised over the documentation of the trial."

The lawsuit took over 15 years for Pfizer to settle, surprising then that they would use children to promote the safety and efficacy of a relatively new product of theirs.

BMJ ARTICLE

Pfizer chiefs were left red-faced after an investigative piece appeared in the BMJ (2 November 2021) raising serious concerns about poor practices at a contract research company (Ventavia) helping to carry out Pfizer’s pivotal covid-19 vaccine trial.

Armed with information from a whistleblower, investigative journalist, Paul D Thacker, highlighted:

  • Participants placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.

Pfizer remained quiet after the BMJ article surfaced...but not for long.

On Nov 9, they tweeted out a meme accompanied with the following message, "It’s easy to get distracted by misinformation these days, but don’t worry…Science has got your back."

Because of the backlash received from their 'Superheroes' video, Pfizer blocked any public comments on this one.

It seems odd that Pfizer would engage in such a way. History shows that when any drug company comes under fire for falsifying clinical trial information (albeit by proxy) they usually remain quiet. Pfizer doubling-down here is a rare move.

It seems this is the way in which Pfizer are going to tackle critics of their vaccine.

'PEOPLE ARE CRIMINALS'

On the same day they launched the meme via Twitter, CNBC published an interview with Pfizer CEO, Albert Bourla. They eye-catching headline from CNBC reads:


Berkeley Lovelace Jr, the journalist who authored the piece, wrote:

People who spread misinformation on Covid-19 vaccines are “criminals” and have cost “millions of lives,” Pfizer CEO Albert Bourla said Tuesday.

Speaking with Washington D.C.-based think tank Atlantic Council, Bourla said there is a “very small” group of people that purposefully circulate misinformation on the shots, misleading those who are already hesitant about getting vaccinated.

“Those people are criminals,” he told Atlantic Council CEO Frederick Kempe. “They’re not bad people. They’re criminals because they have literally cost millions of lives.”

This, to me at least, is yet another rarity. Some would suggest that Bourla is concerned about the whistleblower findings published in the BMJ and is deflecting here.

It's a strange allegation to make given that Pfizer, in 2009, agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.

At the time, Mike Loucks, acting U.S. Attorney for the District of Massachusetts, had this to say:

"Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws."

Pot, kettle, and black anyone?

Bob Fiddaman



Tuesday, September 07, 2021

Informed Consent - Irrelevant, Inappropriate Spam

 

Spam

irrelevant or inappropriate messages sent on the internet to a large number of recipients.

Following on from 'Are Nurses Conspiracy Theorists?', which contained a video of nurses who gathered at a town hall in Minnesota to air their views about the safety and efficacy of the vaccine, I now have to report that Facebook have deemed that the 1 hour plus presentation is deemed to be going against Facebook's "community standards". (Fig 1)


Fig 1

It seems a bizarre move by the social media giant given that they are, allegedly, all about correct information being disseminated on their platform. What can be more 'on the ball' than nurses working the front lines in hospitals? Or are Facebook suggesting they are 'tin-foil hat' wearers?

If you've not seen the video yet, then I highly recommend it.

Today, I share another video. It was posted by Instagram user, kaitlinjaramillo, and features two women who show us all the patient information leaflet that accompanies the current Covid vaccines. Obviously, one cannot take a video at face value, so I did some digging into this.

It appears it's not the first video to hit social media regarding the, for want of a better word, "lack" of information being handed out to pharmacists and, indeed patients.

The reasoning behind this "lack" of information is equally baffling.

Here's the video:


According to Truthmeter, an apparent fact-finding website, patient inserts on vaccines are intentionally left blank because data is constantly changing. Instead, the blank pages offer the reader a QR code and a website on which the latest vaccine information is published.

This, at first glance, appears all well and good, however, you can only access the website if you are  a Healthcare Professional in the US. Patient's, it appears, cannot access what is, in essence, theirs. (Fig 2)

Fig 2 (Click on image to enlarge)

So, with Facebook, seemingly, cautioning people who post access to information regarding the vaccine, and Janssen, a pharmaceutical company, only allowing healthcare professionals access to this information, where does that leave the consumer?

It appears Janssen will only allow healthcare professionals access, this includes nurses who, according to the definition of the word 'Spam' sees Facebook flagging such posts because they are "irrelevant or inappropriate" (Fig 3)

Fig 3


What's more "irrelevant or inappropriate", access to patient safety information or no access to patient safety information?

These are the times we are living in, folks!

Bob Fiddaman

Back Stories




Monday, August 23, 2021

Informed Consent ~ Changing the Paradigm

 


Rarely does a video cause me as much anger as one I recently viewed via Twitter. Before reading on, please view it below or here



After hearing Dr. Samuel White's story, I searched for an unedited version of the video and additional info about White, who has been a doctor in NHS for more than 17 years. White is now facing an interim orders tribunal regarding his fitness to practise. The Medical Practitioners Tribunal Service (MPTS) will carry out a tribunal to decide whether to:

1.Impose an interim order of conditions on White's medical registration.
2.Impose an interim order of suspension on White's medical registration.
3.Make no order.

As part of the ongoing process, White's licence to practise medicine within the NHS was suspended by a letter the NHS sent on 26 June 2021. His rebuttal, via his lawyers, can be seen here.

White has been temporarily suspended for telling his patients to review data provided by two government websites: the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Adverse Event Reporting website in the UK and the Vaccine Adverse Event Reporting System (VAERS) in the US.

As of 8 August 2021, MHRA states they have received 342,014 reports for all the combined vaccines and that this accounts for more than 1 million total reactions, 1,559 of which were fatal. (Fig 1)

CLICK ON IMAGE TO ENLARGE
Image courtesy of UK Column


This government-provided data is what Dr. White told his patients to read when deciding whether or not to have the COVID vaccine. The figures above change weekly and will increase as more people report their adverse reactions. It's also important to remember that because many adverse reactions and deaths are never reported to the MHRA, these figures above do not tell us the whole story.

The MHRA will argue that the reported reactions and deaths do not necessarily mean the vaccine caused them, often using the phrase, "correlation does not equal causation." They have done this throughout history with medicines that cause adverse events and even deaths.

White was giving his patients as much information as he had at his disposal; he didn't have the weekly stats for the vaccines' adverse events; hence his common-sense suggestion that patients check the two websites is appropriate. 

So what is Informed Consent?

It seems an easy question to answer, but no doctor can provide patients with all the information needed for fully informed consent because data from clinical drug trials is withheld from medical professionals and consumers. 

1. You must have the capacity (or ability) to make the decision.

2. The medical provider must disclose information on the treatment, test, or procedure in question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur.

3. You must understand the relevant information.

4. You must voluntarily grant consent, without coercion or duress.

Let's take a closer look at #2

For doctors to relay information about benefits and risks to their patients, they need all the information. But doctors and the MHRA do not receive all the data from the drug companies. Case Report Forms (CRFs) are individual patient data from clinical trials. These are all kept under lock and key--the only time one is ever granted access to CRFs is when a request for disclosure is made. Disclosure refers to a litigation procedure where each party in the suit must disclose any/all documents that may be considered relevant to the pending court case.

The likelihood of CRFs from COVID vaccine clinical trials ever seeing the light of day is slim given that AstraZeneca, Pfizer, and Moderna, have all been granted indemnity. In other words, consumers who suffer from taking these COVID-related products can never sue the company that made them. So, no litigation, no CRFs.

Having no access to CRFs is bad enough, yet we also have ghostwritten "medical literature."

Who You Gonna Call?

Most people who see the names of medical doctors or Ph.D.'s followed by affiliated academic institutions as authors of medical journal articles likely believe the drug data and product claims promoted. The pharmaceutical companies promote these erroneous assumptions using a scheme called ghostwriting.

The authors of ghostwritten articles have not written them or read all the clinical trial data. Instead, the drug companies hire PR firms to draft articles and send them to academics who lend their names as authors. A classic example of this was ghostwriting PR outfit, Scientific Therapeutics Information (STI), that worked for drug kingpins, GlaxoSmithKline (GSK).

In a nutshell, GSK's pediatric trials for Paxil returned abysmal results. However, GSK knew all was not lost. The company only needed child psychiatrists to promote Paxil for kids by claiming the drug was safe and effective. STI's ghostwritten article helped convince many doctors to convince many parents that Paxil was safe for children. Years later, we learned through litigation why GSK never shared the clinical trial data: Internal documents showed GSK was worried that their clinical trial data would reduce product sales. 

You can read more about this case here, here, and here.

Doctors, including Samuel White, are not obliged to research drug company malfeasance; moreover, even if they did their own research, they are not obliged to inform patients of their findings.

The USA

An article published in the British Medical Journal (BMJ) on 20 August 2021 highlights how the American equivalent of the MHRA, the Food and Drugs Administration (FDA), is preparing to grant full approval of the Pfizer vaccine without publicly discussing the data. Only a year ago, the FDA said it was "committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public."

So, why the sudden U-turn? Experts quoted in the BMJ article said politics drove the decision not to meet to discuss the data. Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings, said, "It's obvious that the FDA has no intention of hearing anyone else's opinion. But if you make decisions behind closed doors it can feed into hesitancy. It's important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know."

The FDA and MHRA don't want to discuss the data because, as I previously stated, they don't have all the data.

Ladies and gentlemen, this is the publicly funded smoke-and-mirrors shit show being performed for us. The truth of the matter is, everything is being hidden in plain sight. Whether you have taken these COVID drugs or not, you should question all of the above. It is easy (and lazy) to post memes on Facebook or Twitter chastising those who choose not to take these vaccines. It's easy to label people who don't get in line for pharma's new COVID products and call them "anti-vaxxers" or "conspiracy theorists.' Similar labels were assigned to folks who spoke out about the dangers of promoting and prescribing Paxil to children. Yet years later, GSK's lies were exposed during wrongful death litigation. 

Informed Consent ~ Changing the Paradigm

I'd like to see the term 'informed consent' used less frequently. It is meaningless when a doctor or patient does not have access to all the data. Instead, I'd like to use the opposite term, 'Informed refusal'.

Informed refusal is where a person has refused a recommended medical treatment based upon an understanding of the facts and implications of not following the treatment. Individuals need to be in possession of the relevant facts, all of them.

This may stick in the teeth of those who have already had the vaccine, a lot of whom claim that people who refuse the vaccine don't have any rights, 'it's not about them', we hear, 'it's about others.'

So, my right to informed refusal is based on the lack of data coming from the likes of Pfizer, Moderna and AstraZeneca and now the FDA. Based on the information they are not giving me, I refuse to be treated and if that upsets those who have been treated and limits my freedoms, then so be it.

I'm on the side of truth, not suppression, be that in the form of access to raw data or the posting of infantile memes on social media by the 'monkey see, monkey do' individuals, all, of course, designed to silence those with the ability to think freely without fear. 

Fearbook

I've never seen a divide happen so quickly. On both Facebook and Twitter I now see posts from people declaring that they are deleting friends from their list who speak out about the vaccine, all fuelled by the regular 'flags' we now see daily on Facebook anytime anyone posts something negative about treatment. Flags such as:

So, it's okay to click on the 'Get Vaccine Info' link but, seemingly, not okay to click on any information that may oppose this information.

When Facebook go a step further and actually remove opinion you have the right to ask why. Here's the standard reply you get:

As this blog of mine points out, Facebook moderators don't have access to the safety or side effect data of COVID vaccines, they couldn't possibly know what is true or false.

The best one I've seen so far is the following:

So, a post or link of yours may offer 99% truth but Facebook 'fact-checkers' flag it for containing 'partly false' information.

More Jabs

The United States will begin widely distributing Covid-19 booster shots next month as apparent new data shows that vaccine protection dwindles over time.

“We are starting to see evidence of reduced protection against mild and moderate disease,” according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20, starting eight months after their second dose of Pfizer or Moderna’s vaccines.

So, the freedoms given to those who have currently been double-jabbed, concerts, sporting events, travel, will, seemingly, be taken away unless they have the booster.

Viruses mutate over time, they can strengthen or weaken. The majority of vaccines are developed over time and not rushed to market. Just because a vaccine gets approval (albeit 'Emergency Approval') does not make it safe. Data is collected and supposed to be assessed. This is called Post-Marketing Surveillance, designed to collect all the adverse events from the public. Most people don't know that clinical trials do not end in the lab - Any drug or vaccine that comes to market is just another phase of a clinical trial.

Dr White's bosses and, it seems, Facebook 'Fact-Checkers' are doing everything in their power to deter you and I from checking out the Post-Marketing Surveillance data. This is real-world data and not the data of a clinical trial setting.

You have to ask yourself, why the suppression?

Those who oppose members of the public who question the safety and efficacy of the COVID-19 vaccine will, no doubt, continue to post various memes supporting the use of vaccines in adults, children and expectant mothers. Their pious position will be supported with posts and links to celebrities, journalists and ghost-written articles that appear in academic journals. None of these will be flagged by Facebook.

As I said before, Monkey see, monkey do.

As a side-note, I first heard about COVID-19 on January 1st 2020 (Back then it was just known as the "Corona Virus"). I was in Central America at the time and a neighbour of mine invited me over to his place for afternoon drinks. He asked me if I'd heard about the outbreak, he had business in China so was more up-to-speed than I.

A month or so later, I was back in the UK visiting family and friends. Within weeks of me landing back in Blighty, the whole country was locked down. It was then that I wrote a series of predictions. You can see those predictions here. People back then rolled their eyes at me and no doubt those same people will be rolling their eyes at this blog post.

Bob Fiddaman






Tuesday, December 29, 2020

Apathy is the New Normal

 


As more people increasingly express their views about the safety and efficacy of the Covid vaccine, we also see more news articles stating the virus has mutated. 

Supposedly, it is more dangerous and infectious. Current speculation is that the UK will soon enter a stricter Tier 5 quarantine. There is also speculation that travel restrictions will be imposed if one refuses the vaccine. 

We are now being told that there are fewer cases of the "normal" flu this year because the public is wearing masks. However, it appears that mask-wearing does not stop the Covid virus spread.

How is this possible? 

Businesses have been closed on the back of experts saying a non-compliant public is breaking the law, a law prompted by the same "experts". at the same time experts are proclaiming "the majority of the public are sticking to the new rules." It's a pat on the back for those who comply.

Those who question the safety and efficacy of the Covid vaccine often do so on social media, which is now policed by "fact-checkers" who ultimately have the final say. 

Nobody can take to the streets anymore to protest. To do so, we are told, "puts lives at risk."

We are, for want of a better word, jailed, but let out occasionally for exercise. We are living isolated lives and only see people within our own bubble. There is little opportunity to hear different and challenging opinions. Tier 5 may even dismantle those bubbles and further restrict us from seeing loved ones.

We are told mental disorders are rising in part because people are worried about the future.

Online retail corporations are becoming richer by the day as small businesses are forced to close. Amazon, Netflix, and online supermarkets are having a bumper year!

Pubs, where political debates are typically hot topics, have also been forced to close their doors. 

Restaurants are currently open, but you must dine then dash. Expect Tier 5 to stop this small window of discussion amongst family, friends, and strangers. 

In the midst of this, we have an invisible virus that has become almost impossible to debate. It's bad. It's killing people. It's infecting people. But, hey, don't worry, we have drug companies working on a solution - the same drug companies who have been fined billions for violating health-related rules and regulations.

We can always shrug our shoulders and give them another chance, right? 

Apathy is here, and is forced upon many, some of whom are unaware that the government want an apathetic public and benefit from such. It is understandable that the public just want this Covid nightmare to end and will accept any solutions. They have largely been compliant and chastise those who have different opinions. It's fear at play, the same fear we saw 10 months ago when photos were released of dead bodies on the streets and on the hospital floors of Wuhan. The popular tabloid, The Sun, proclaimed Jan 2020 that, "Coronavirus leaves Wuhan a ‘zombieland’ with people collapsing in streets and medics patrolling in hazmat suits." 

It sowed the seed of what was to come, what has become. This transpired despite that some of these photos were not authentic.

We are humans and are all influenced. Yet, it seems today's influence is one-sided and led by the government-fed media.

This post may be flagged by a Google bot picking up certain words. Remember, it's only an opinion, an opinion that many may agree with but are not be allowed to share, at least not in bars, restaurants, or any other public place. It remains to be seen if this blog can be shared on social media platforms. 

I'm an observer and like to weigh up things before I write. I've been publishing about drug company and regulatory fraud for over 16 years. Many years have been frustrating as, in the main, I've been preaching to the same choir. People outside of this choir typically are members of the apathetic public.

I know how drug companies and regulators operate. I know they, their paid "experts", and celebrity endorsers, like to instil public fear. 

I know.

Bob Fiddaman

“Fear has two meanings: ‘Forget Everything And Run’ or ‘Face Everything And Rise.’ The choice is yours.”— Zig Ziglar


Thursday, August 20, 2020

Baum Hedlund Take a Stand Against Vaccine Maker

 

Los Angeles based law firm, Baum Hedlund Aristei & Goldman filed a Gardasil lawsuit against Merck yesterday on behalf of Julia Balasco, a 19-year-old, who suffered severe and permanent physical injuries after receiving multiple injections of the human papillomavirus (HPV) Gardasil vaccine.

Merck, the makers of the controversial vaccine, are accused of failing to properly test Gardasil before the HPV vaccine was fast-tracked and administered to millions of young girls and boys throughout the United States and the world. It is also alleged that "Merck knew or had reason to know that its vaccine was defective and ineffective, but instead of warning the medical community and the public, the company wrongfully concealed information and further made false statements concerning the safety and efficacy of Gardasil."

Furthermore, it is claimed that Merck manipulated the Gardasil clinical trials by spiking the placebo with AAHS and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions thus giving the impression that Gardasil was just as safe as taking a placebo.

Julia Balasco was just a 13-year-old when she was administered Gardasil. Her mother, Michaela, the lawsuit claims, was persuaded by the various Merck ads for Gardasil that claimed it was 'very safe' and 'prevented cancer'. Little did she know that her daughter would later develop serious and debilitating autoimmune disease, including POTS, a disorder that affects a branch of the nervous system that regulates functions we do not consciously control, including blood pressure, heart rate, perspiration, and body temperature.

Merck are no strangers to controversy. The New Jersey drug company have been fined over $3 billion dollars since 2000, some of which include health and safety-related offences (see below)


You can read more about the case of Julia Balasco here

Bob Fiddaman



Monday, June 08, 2015

GSK Formed a "Cartel"






Cartel: an association of manufacturers or suppliers with the purpose of maintaining prices at a high level and restricting competition.

The media is awash with reports this morning that the Competition Commission of India (CCI) imposed a fine on GlaxoSmithkline Pharmaceuticals and Sanofi India for collusive bidding in supply of a meningitis vaccine to the government for Haj pilgrims.

Hmm, Glaxo up to no good, surely not?

The complaint was filed by Bio-Med Pvt Ltd, a small pharmaceutical company that also manufacture and supply a meningitis vaccine.

India's CCI also said, in a report, that...

"They have not produced any evidence either before the DG or before the Commission to substantiate their claims. In the absence of any evidence, the Commission notes that the assertions made by opposite party 2 (GlaxoSmithKline) and opposite party 2 (Sanofi) are merely bald statements and also appear to be an afterthought to justify their illegal, collusive conduct," 

Illegal collusive conduct. Hmm!

The CCI also  warned GlaxoSmithKline and Sanofi to "cease and desist" from anti-competitive practices.

Glaxo's company tagline is, Do more, feel better, live longer.

They are certainly living up to that tagline by "doing more" in respect of their illegal shenanigans.

Glaxo and Sanofi were fined Rs 60.45 crore and Rs 3.04 crore respectively.

SourceCCI slaps a fine of Rs. 64 crore fine on GlaxoSmithKline, Sanofi


Bob Fiddaman







Monday, June 09, 2014

Irish Babies and GSK - Why the delay?




News that almost 800 bodies of babies had been found in a septic tank in Ireland surfaced last week. Now known as the 'Irish Baby Graves Scandal', 796 babies are thought to have been interred alongside what was called "The Home", run by Bon Secours nuns in Tuam. The proprietors took in "fallen women" and "illegitimate children" between the 1920's and 1960's.

The story has been linked to a vaccine clinical trial from the 1930's. The International Business Times writes...

Over 2,000 babies and young children at a number of Irish orphanages linked to the mass baby graves scandal were injected with a vaccine for diphtheria in the 1930s, it has been revealed. The children were used as guinea pigs on behalf of drugs giant Burroughs Wellcome. No evidence of consent has been discovered and there are no records of how many children became ill or died as a result.

Burroughs Wellcome, later subsumed into drugs giant GlaxoSmithKline (GSK)

Many are sickened by this news and both GSK and the Catholic church have come under fire.

It's a story, however, that isn't as fresh as what the mainstream press are letting on.

Four years ago, in 2010, the Irish Independent reported that legal action was being planned against GlaxoSmithKline and the Sacred Heart Order, which allowed the tests at the Bessborough Mother and Baby Home in Cork.

Campaigner and abuse survivor John Barrett alleged that was used in four different experiments when he was aged 12 and 13 at the Lota home.


He said: "All of the boys of my age were taken off and given tests, X-rays and general examinations.

"Lists were made of those deemed to be 'healthy' and we would sometimes be lined up in one of the dormitories and given massive injections."

At the time of these revelations the then Irish Health Minister, Mary Harney, was called on to instruct her officials to make available all relevant information regarding the ongoing vaccine trials.

The call, according to the Irish Times, came as a result of Mari Steed, 50, breaking her silence into how she was subjected to a controversial vaccine trial as a baby without her mother's consent.

She said she the trial were carried out on her between December 1960 and October 1961, when she was between nine and 18 months old.

Ms Steed, who in 2010 was living in the US, and three others, were preparing to take legal action in US courts against GlaxoSmithKline.

Whatever came of that legal action?

Moreover, did  the then Irish Health Minister, Mary Harney secure all relevant information regarding the ongoing vaccine trials?

Do GlaxoSmithKline still hold records that belonged to Burroughs Wellcome, if so, why haven't these documents been released to investigators?

Why, four years on are we still asking for these documents and why, four years on, are GlaxoSmithKline being quoted as saying,  “The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.

“We would need further details to investigate what actually took place, but the practices outlined certainly don’t reflect how modern clinical trials are carried out. We conduct our trials to the same high scientific and ethical standards, no matter where in the world they are run.”

Was the investigation four years ago brushed under the carpet, was an out of court settlement made to those who intended to file a lawsuit in the US?

Who, exactly, is at fault here, is it the Irish government, the Catholic church or GlaxoSmithKline?

Not much is known about these clinical trials, the whole scandal seems to have been put to bed for the last four years...only to resurface again with the 'Irish Baby Graves Scandal'.

A good source of information can be found on Paddy Doyle's website, The God Squad. Paddy has been investigating the whole sordid affair for sometime now.

In the meantime we wait for Glaxo to get the "further details to investigate what actually took place".

Don't hold your breath folks.


Related

Pressure mounts for GSK [inquiry into trials of vaccines]



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













Tuesday, January 03, 2012

Glaxo Fined £60,000 For Killing 14 Babies



Throw a cat in a bin and get massive media coverage and public outrage. Kill 14 babies and our British press don't even give it a small column. We've lost our morals folks. Glaxo are a British company and their wrong-doings should be reported by the British press. With James Murdoch on the board at GSK and with Andrew Witty cupping the balls of the UK government with the threat of moving his business elsewhere, it's left, once again, to bloggers to report on this abhorrent misuse of human life.

What price a human life?

Well Judge Marcelo Aguinsky has fined GlaxoSmithKline 400,000 Argentinian Pesos [about £60,000] for its part in the 2007/08 vaccine trials conducted in Argentina where 14 children died. The charges, writes the Herald, included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

The Buenos Aires Herald reports:


The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.

By my reckoning that's just over £4,000 per child.


"GSK Argentina set a protocol at the hospital, and recruited several doctors working there," Pediatrician Ana Marchese told Continental AM radio in an interview. Adding that:

“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries."


GlaxoSmithKline Argentina are appealing the decision. Medical Director Rosana Felice said in a statement, "None of the deaths are related to the vaccines", and added, "Likewise, Glaxo doesn’t pay any kind of bribes in order to lead any clinical studies here in Argentina or at any other location around the globe."

Phew! Thank goodness for that, for one minute I thought they had actually been rumbled.


The GlaxoSmithKline corporate motto is, "We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."


Based on the findings in the above enquiry I'd suggest that GlaxoSmithKline look up the words 'Inspiring', 'Improve' and 'Quality'.



Full shameful story in the Buenos Aires Herald

Heads up: Pharmalot

Back story: Is GlaxoSmithKline Behaving Badly in Argentina?


On January 1st Glaxo CEO Andrew Witty was knighted.

Nice to see our monarchy getting its priorities in order.







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]


Tuesday, November 15, 2011

GlaxoSmithKline's Cervarix Under The Spotlight [Again]



Fresh from paying off a recent fine of $3 billion for illegally marketing it's brand of drugs, Paxil, Wellbutrin and Avandia, pharmaceutical giants, GlaxoSmithKline, were yesterday embroiled in another tale of woe regarding another of their products.

This time it's their widely promoted safe vaccine for teenage girls, Cervarix.

Many of the British newspapers are covering the story of Lucy Hinks who, at the age of just 13, has been left in a "waking coma" after suffering suspected side effects from the Cervarix vaccine.

Glaxo, in usual style, have rolled out the tired and trusted one-liners that has stood them firm for years when defending drugs such as Avandia and Seroxat.

This from MSN News:

"It [Cervarix] has been shown to be generally well tolerated".

and the old faithfull:

"...we take these reports very seriously."


Ring any bells?

2002 [BBC] GlaxoSmithKline spokesperson Alastair Benbow defending Seroxat with:

"Seroxat is an effective and generally well tolerated treatment for the management of depression."

Or

"We take the safety of our medicines extremely seriously." - Transcript GSK Tape – Panorama Interview – Dr Alastair Benbow 9 October 2002


Personally, I think the comments from GSK spokespersons are being generally well tolerated by the British public, be nice if we had some transparency occasionally, doncha think?

In June 2008 a promotional DVD was sent to every G.P in the UK just hours before the launch of the Cervarix vaccine in the UK. The DVD was posted with the G.P. magazine and was a clever marketing strategy aimed at busy G.P.'s to 'brainwash' them into believing that the Cervarix vaccine protected young women from the perils of cervical cancer.

The comments at the start of this video juxtapose the claims made by GSK in the promotional video.



For more information:

http://sanevax.org/ 
http://www.americanchronicle.com
http://vactruth.com/







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


AUSTRALIAN ORDERS HERE 




Monday, April 25, 2011

Global Concerns about HPV Vaccines in London

Image: associatedsource.com


UK journalist Christina England has a new article up on the website 'American Chronicle' regarding HPV vaccines. Her opening paragraph sets the tone for another imformative piece of news reporting from her. She writes:

In March this year, the British Society for Ecological Medicine held their spring conference in London. The conference entitled 'A tablet a day keeps the patient at bay - The Health Hazards of Prevention - Vaccinations and Pharmacoprophylax' brought together experts from around the world to speak on the dangers of childhood vaccinations and prescription medication.

This years speakers included MMR experts Dr Andrew Wakefield and Dr Jayne Donegan, Dr Lucija Tomljenovic from the University of British Columbia and Dr Ellen Grant. Also joining this years panel of experts were Leslie Carol Botha, Women's Health Educator and Vice-President, Media Relations, SaneVax Inc, (USA) and Freda Birrell, Political Advisor and Secretary, SaneVax Inc (Scotland) both speaking on behalf of S.A.N.E. Vax Inc.

She adds, "Botha and Birrell proved without a doubt, through facts and statistics, that the vaccinations Gardasil and Cervarix did not fit the SaneVax's criteria . The vaccines are not safe, they are not affordable, they are not necessary and they are very far from being effective in winning the war against cervical cancer."

It's a fascinating article and one that should be read by parents who have to make a decision regarding these two particular vaccines.

The whole article can be read HERE

Christina has also recently co-authored a book with Harold Buttram M.D entitled, "Shaken Baby Syndrome or Vaccine Induced Encephalitis - Are Parents Being Falsely Accused?"


The blurb for the book reads:

In 1971 Norma Guthkelch, retired neurosurgeon, published the first description of the Shaken Baby Syndrome (SBS). Within the next several years John Caffey, pediatric radiologist, wrote several articles supporting the SBS theory. Very soon after, when infants were brought into hospital emergency rooms in the U.S.A. with brain hemorrhages without known accidental explanations such as auto accidents or high distance falls, almost routinely the hemorrhages have been attributed to SBS or related diagnoses resulting in criminal conviction of parents or caretakers. These and other issues such as inflicted child abuse, non-accidental trauma, failure to protect, and other diagnoses are reviewed in this book

“Since the original introduction of the SBS theory, conclusive evidence has emerged proving that these prosecutions have been founded upon tainted medical opinions and fundamentally flawed scientific methodology (i.e. junk science). It requires little imagination to understand the significant mental pain which parents undergo while grieving over the death of a child, as frequently occurs in these cases. Accusing this parent of murdering their child (with no real evidence) and putting the entire strength of the state behind this accusation is monstrous, when the entire accusation pivots upon facts which are now known to be false. Loss of job, loss of family and community ties follow the accusation.

Moreover, the general public, the grand and petite juries, the states and the parties, all have an overwhelmingly strong interest in knowing if these prosecutions are founded upon reasonable interpretation of the facts – or – if the accusations are built around falsehoods and scientific impossibilities.”

The book, published by Authorhouse, can be downloaded for Kindle users HERE or can be ordered as a paperback HERE

Fid



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

Sunday, April 24, 2011

Glaxo's Swine Flu Jab Under Investigation

Within weeks of having the Pandemrix jab, Joshua Hadfield began sleeping 18 hours a day and his mother says his personality completely changed.
Image: Daily Mail


The Daily Mail reported online yesterday that GlaxoSmithKline's vaccine Pandemrix, given to thousands of children across the UK, may cause the sleep disorder narcolepsy.

The European Medicines Agency [EMA] have ruled that ALL packets of Glaxo's vaccine must now carry a warning about the risk.

Not one's for sticking their necks out, the EMA have put the onus on doctors to weigh up the "risk v benefits" when administering the vaccine.

Now there's a surprise - a medicines watchdog passing the buck!

The Daily Mail article highlights the story of five year old Joshua Hadfield who, within weeks of having the Pandemrix jab, began sleeping 18 hours a day and had a personality change.

Glaxo's medicine causing personality change? Surely not.

Joshua's mum, Caroline, said:

"I believe this link will eventually be confirmed. I’m very angry about it.

"I researched the vaccine carefully before agreeing to let Joshua have it and thought I was protecting him. Now he’s saddled with this for life.

"There should have been more testing before it was rolled out and it should have been destroyed at the first suggestion of any problems."

In the words of Canadian rock star Meatloaf, 'you took the words right out of my mouth.'

Full article HERE

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

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