Zantac Lawsuit


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

Tuesday, August 31, 2021

If Pfizer Were a Caregiver - The Elephant in the Room

 



To date, I've not witnessed any person who is refusing Pfizer's vaccine publicly chastise anyone who has chosen to be vaccinated. I have, however, seen plenty of vaccinated people call those who are not vaccinated, "idiots", "stupid", "selfish", "antivaxxers". Many more negative connotations are used, often behind the backs of the unvaccinated.

Although there may be some examples of the unvaccinated targeting vaccinated people, I suspect it's because they are fed up of having the above negative connotations aimed in their directions - I may be wrong.

This post is, in essence, for those people who continue to claim that the unvaccinated are idiots, etc.

I pose a hypothetical question to those people, one, which I feel, should, at the very least, tap into their sense of logic when trying to persuade the unvaccinated to "GET VACCINATED!" (They often use CAPS and exclamation marks to drive their point home) - messages like these are rife on social media, such as Instagram, Facebook, Twitter etc.

As yet, I've not had any answers to this question, apart from, "It's a silly rhetorical device.", this from someone who has publicly stated that he has been vaccinated. Do you see any negative connotations in his response?

Anyway, I digress.

Here's the hypothetical question:

If Pfizer were a caregiver, would you employ them to look after the welfare of your children, grandchildren, and/or elderly relatives?

Before you answer, it may be wise to check out Pfizer's CV.

Here it is (Sources provided at the end of this blog post)

Products
- The Food and Drug Administration (FDA) expressed great concern about reports of dozens of fatalities linked to heart valves made by Pfizer’s Shiley division. In 1986, as the death toll reached 125, Pfizer ended production of all models of the valves. In 1991 an FDA task force charged that Pfizer’s Shiley division had withheld information about safety problems from regulators in order to get initial approval for its valves and that the company continued to keep the FDA in the dark. A November 7, 1991 investigation in the Wall Street Journal asserted that Pfizer’s Shiley division had been deliberately falsifying manufacturing records relating to valve fractures. Pfizer announced that it would spend up to $205 million to settle the tens of thousands of valve lawsuits that had been filed against it. Even so, Pfizer resisted complying with an FDA order that it notify patients of new findings that there was a greater risk of fatal fractures in those who had the valve installed before the age of 50

- In 2004, Pfizer agreed to suspend television advertising for a related medication called Celebrex. The following year, Pfizer admitted that a 1999 clinical trial found that elderly patients taking Celebrex had a greatly elevated risk of heart problems.

- In 2005, Pfizer withdrew another painkiller, Bextra, from the market after the FDA mandated a “black box” warning about the cardiovascular and gastrointestinal risks of the medication. In 2008, Pfizer announced that it was setting aside $894 million to settle the lawsuits that had been filed in connection with Bextra and Celebrex. The settlement included roughly 7,000 personal injury cases, mainly plaintiffs who took Bextra, The attorney represented 2000 claimants, about 10% of them relatives of people who died.

- In 2010, a federal jury awarded $1.37 million to a former Pfizer scientist who claimed she was sickened by a genetically engineered virus at a company lab and was then fired for raising safety concerns.

Children
- In 2000, the Washington Post published a major exposé accusing Pfizer of testing a dangerous new antibiotic called Trovan on children in Nigeria without receiving proper consent from their parents. The experiment occurred during a 1996 meningitis epidemic in the country. In 2001, Pfizer was sued in U.S. federal court by thirty Nigerian families, who accused the company of using their children as human guinea pigs. Eleven of the children reportedly died, while the remaining 181 were said to have suffered from deafness, paralysis, brain damage and blindness.

- In 2006, a panel of Nigerian medical experts concluded that Pfizer had violated international law. In 2009, the company agreed to pay $75 million to settle some of the lawsuits that had been brought in Nigerian courts. The U.S. case was settled in 2011 for an undisclosed amount. A Pfizer spokesperson had previously claimed, "The study saved lives and was conducted ethically and responsibly."

Environment
- In 1971, the Environmental Protection Agency asked Pfizer to end its long-time practice of dumping industrial wastes from its plant in Groton, Connecticut in the Long Island Sound. The company was reported to be disposing of about 1 million gallons of waste each year by that method.

- In 1991, Pfizer agreed to pay $3.1 million to settle EPA charges that the company seriously damaged the Delaware River by failing to install pollution-control equipment at one of its plants in Pennsylvania.

- In 1994, Pfizer agreed to pay $1.5 million as part of a consent decree with the EPA in connection with its dumping at a toxic waste site in Rhode Island.

- Pfizer have also settled wrongful death cases of both adults and children regarding Zoloft's propensity to induce suicide. Despite settling these cases, Pfizer still deny that Zoloft can induce suicide.

Zoloft has generated over $30 billion in sales since its release in 1991, but research suggests that the drug is, at best, little more effective than a sugar pill.

To date, Pfizer has been fined a total of $4,660,896,333 for various violations

I suspect many who have chose not to be vaccinated don't quite trust this particular multi-billion dollar corporation and, more than likely, are completely cheesed off at individuals calling them out with their slanderous comments.

The question still remains. If Pfizer were a caregiver, would you employ them to look after the welfare of your children, grandchildren and/or elderly relatives?

Answers on a postcard, please...

Bob Fiddaman




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







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