Remarks: Either leaked or hacked, documents show issues arose in November, 2020 about mRNA vaccine quality assurance, specifically critical RNA instability. More recently, warnings are being issued about the lipid nanoparticle component of the mRNA vaccines, responsible for many of their side effects FULL STORY HERE: https://www.4cmitv.com/2021/03/30/2021-mar-24-can-you-trust-big-pharmas-gene-therapy-vaccine/
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» Some of the same drug companies now responsible for developing and manufacturing fast-tracked COVID-19 vaccines were also responsible for creating the opioid crisis in the U.S., which has killed as many Americans as have died from COVID-19
» Most have also been convicted of other unethical and criminal activities over the years, any of which puts their ethical fitness into question
» In 2019, an Oklahoma court found Johnson & Johnson partially liable for the “human and financial costs” of the opioid epidemic in the U.S. and ordered the company to pay $572 million
» Two other COVID-19 vaccine makers, Pfizer and AstraZeneca, are habitual offenders, having repeatedly engaged in illegal and corrupt marketing practices, bribery and science suppression. Pfizer’s vaccine plant, where COVID-19 vaccine vials are to be filled, also has a long history of quality control problems
» Research confirms the suspicion that the lipid nanoparticles used in Pfizer’s and Moderna’s vaccines are highly inflammatory, and may be responsible for many of the adverse effects reported
As noted by Russel Brand in a recent video commentary (above), some of the same drug companies now responsible for developing and manufacturing fast-tracked COVID-19 vaccines were also responsible for creating the opioid crisis in the U.S., which has killed as many Americans as have died from COVID-19.
Most have also been convicted of other unethical and criminal activities over the years, any of which puts their ethical fitness into question. Not surprisingly, opioid addiction and overdose deaths skyrocketed during 2020 lockdowns and, now, COVID-19 vaccines are taking their toll as well.
Johnson & Johnson Found Partly Liable for Opioid Crisis
In 2019, Johnson & Johnson was found partially liable for the “human and financial costs” of the opioid epidemic in the U.S. and was ordered to pay $572 million to the state of Oklahoma. While the company denied any wrongdoing, “data revealed during the trial proved a culture of downplaying the risks of opioids to customers and physicians,” Cassiobury Court reported, adding:fn01 Cassiobury Court September 10, 2019
“Sales representatives were trained to tell doctors that the risk of addiction was 2.6% or less if the drugs were prescribed by a doctor and, most shockingly, doctors were specifically targeted as ‘key customers’ if they had a history of prescribing a high amount of opioids.”
In “Capitalism Gone Wrong: How Big Pharma Created America’s Opioid Carnage,” published in The Guardian July 24, 2019, Chris McGreal, author of “American Overdose, the Opioid Tragedy in Three Acts,” wrote:fn02 The Guardian July 24, 2019
“Oklahoma’s attorney general accused the company of a ‘cunning, cynical and deceitful scheme’ to ramp up narcotic painkiller sales as one of a web of firms that created the biggest drug epidemic in American history as profits surged. The companies worked in step to change medical culture and practice by influencing doctors, researchers, federal regulators and politicians.”
Curiously, as noted by Brand, Johnson & Johnson’s stock price rose by 5% immediately following that verdict. What this means, he suggests, is that we’ve created systems that encourage malpractice. Profit motives override all other concerns, including lethal effects.
When companies engage in unethical behavior, especially the falsification and manipulation of science, they create distrust and cynicism. This should be obvious, and it’s nobody’s fault but their own.
Importantly, Johnson & Johnson made false claims about the safety of its opioid, going so far as to manipulate scientific papers to support its assertion that the risk of addiction was less than 2.6%.fn03 Cassiobury Court September 10, 2019 As Brand points out, when companies engage in unethical behavior, especially the falsification and manipulation of science, they create distrust and cynicism.
This should be obvious, and it’s nobody’s fault but their own. We can point to these very specific examples and say, “Look here. They manipulated and falsified science to make money. When they were caught, all they had to do was pay a manageable fine, which they recouped through a rise in stock price.”
If it happened once (and believe me, it’s happened more than once), it can happen again. And if it can happen at all, why couldn’t this unethical behavior occur when creating what is expected to be a phenomenally profitable pandemic vaccine? We’re told we must not question the safety or effectiveness of COVID-19 vaccines, yet the histories of the makers are such that not questioning everything they do would be naïve in the extreme.
Johnson & Johnson has also been involved in a long list of product safety and contamination issues, marketing and safety violations, government contract violations and foreign corrupt practices resulting in hundreds of millions of dollars in fines. You can find their rap sheet on the Corporate Research Project’s website.fn04 Corporate Research Project Johnson & Johnson
Pfizer’s Long History of Unethical Behavior
In 2014, it was ordered to pay $75 million to settle charges relating to its testing of a new broad spectrum antibiotic on critically ill Nigerian children. As reported by the Independentfn06 The Independent March 23, 2014 at the time, Pfizer sent a team of doctors into Nigeria in the midst of a meningitis epidemic.
For two weeks, the team set up “within meters” of a medical station run by Doctors Without Borders and began dispensing the experimental drug, Trovan. Of the 200 children picked, half got the experimental drug and the other half the already licensed antibiotic Rocephin. Eleven of the children treated by the Pfizer team died, and many others suffered side effects such as brain damage and organ failure.
Pfizer denied wrongdoing. According to the company, only five of the children given Trovan died, compared to six who received Rocephin, so their drug was not to blame. The problem was they apparently never told the parents that their children were being given an experimental drug.
What’s more, while Pfizer produced a permission letter from a Nigerian ethics committee, the letter turned out to have been backdated. The ethics committee itself wasn’t set up until a year after the trial had already taken place.
In his 2010 paper,fn07 Healthcare Policy 2010 May;5(4):16-25 “Tough on Crime? Pfizer and the CIHR,” Robert G. Evans, Ph.D., Emeritus Professor at Vancouver School of Economics, described Pfizer as “a ‘habitual offender,’ persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results.” Between 2002 and 2010 alone, Pfizer and its subsidiaries were fined $3 billion in criminal convictions, civil penalties and jury awards.
Such sums did nothing to deter bad behavior. In 2011, Pfizer agreed to pay $14.5 million to settle federal charges of illegal marketing,fn08 DOJ October 21, 2011 and in 2014 they settled federal charges relating to improper marketing of the kidney transplant drug Rapamune to the tune of $35 million.fn09 Reuters August 6, 2014
The Corporate Research Project also details Pfizer’s history of bribery, environmental violations, labor and worker safety violations and more.fn10 Corporate Research Project Pfizer Pfizer has also been bullying countries to put up sovereign assets as collateral for expected vaccine injury lawsuits resulting from its vaccine.
Pfizer’s Vaccine Plant Has History of Recalls
A March 10, 2021, articlefn11 KHN March 10, 2021 by KHN also highlights persistent, long-standing problems at Pfizer’s vaccine plant in Kansas, which is slated to start producing COVID-19 vaccines:
“The McPherson, Kansas, facility, which FDA inspectors wrote is the nation’s largest manufacturer of sterile injectable controlled substances, has a long, troubled history. Nearly a decade’s worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the facility as a repeat offender.
FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or fully investigate after production failures.
The 1970s-era manufacturing site has had persistent mold concerns over the years and been the focus of at least four intense FDA inspections since Pfizer took over its operations in late 2015, when it acquired Hospira.”
The plant is going to be a fill-and-finish site for the Pfizer vaccine. The question is whether the site has really cleaned up its act, or whether contamination might become an issue.
“The facility’s record of recalls and field alerts include vials of medication that contained glass and cardboard particles and, as one customer complained, a ‘small insect or speck of dust,'” KHN reports.
“A 2017 FDA warning letter … said the contaminants such as cardboard and glass found in vials posed a ‘severe risk of harm to patients’ and indicated that the facility’s process for manufacturing sterile injectable products was ‘out of control.’”
AstraZeneca’s Extensive Rap Sheet
Then there’s AstraZeneca, whose director of research for the drug Seroquel, Wayne MacFadden, confessed to entering into multiple sexual affairs for the sole purpose of obtaining information and favors that might benefit the company.fn12 CBS News March 12, 2009
Aside from that eyebrow-raising scandal, AstraZeneca has been brought into the halls of justice more than once. Below is but a sampling of its criminal history. Even more can be found on the Corporate Research Project’s “AstraZeneca: Corporate Rap Sheet” page:fn13 Corp-Research.org AstraZeneca
■ In 2003, AstraZeneca was fined $355 million to settle Medicare fraud charges relating to its marketing of the cancer drug Zoladex.fn14 CNN June 20, 2003,fn15 Justice.gov June 20, 2003 Among the many charges they pleaded guilty to was that they had encouraged doctors to illegally request Medicare reimbursements. Four years later, in 2007, the company was ordered to pay another $12.9 million in damages for its overcharging Medicare and private insurance for Zoladexfn16 Corp-Research.org AstraZeneca
■ In 2005, the European Commission fined AstraZeneca 60 million euros for misusing the patent system to delay market entry of competing generics((fn17 European Commission June 15, 2005)),fn18 Corp-Research.org AstraZeneca
■ In 2016, the U.S. Securities and Exchange Commission fined the company $4.3 million for improperly influencing and rewarding prescribers to use their products, in other words, briberyfn21 US SEC File No. 3-17517 (PDF).
AstraZeneca’s Vaccine Is For-Profit After All
Now, AstraZeneca has made a big deal about its vow not to profit from its COVID-19 vaccine. Adrian Hill, director of Oxford’s Jenner Institute and the co-developer of the AstraZeneca vaccine, has gone on record saying “I personally don’t believe that in a time of pandemic there should be exclusive licenses.”fn22 KHN August 25, 2020 As reported by KHN:fn23 KHN August 25, 2020
“Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker. The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said …
‘We actually thought they were going to do that,’ James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford’s pledge. ‘Why wouldn’t people agree to let everyone have access to the best vaccines possible?’”
The fantasy didn’t last long. A few weeks later, Oxford University caved to the urgings of the Bill & Melinda Gates Foundation and signed an exclusive contract with AstraZeneca. According to an article in The Nation,fn24 The Nation October 5, 2020 “Gates himself describes his foundation as intimately involved in the partnership between AstraZeneca and the University of Oxford.”
This vaccine deal gives AstraZeneca “sole rights and no guarantee of low prices,” KHN writes.fn25 KHN August 25, 2020 Indeed, the not-for-profit vow expires once the pandemic is over, and AstraZeneca itself appears to have a say when it comes to declaring the end date. It could be as early as July 1, 2021, according to a company memo obtained by the Financial Times.fn26 Fierce Pharma October 8, 2020
As explained by investigative journalist Whitney Webb in a recent Corbett Report interview,fn27 The Corbett Report February 24, 2021 the actual patents and royalties for the AstraZeneca vaccine are held by a private company called Vaccitech, which has been quite open about the future profit potential with its shareholders, noting that the COVID-19 vaccine will most likely become an annual vaccine that is updated each season. Oxford University itself also stands to make millions from the deal. According to KHN:fn28 KHN August 25, 2020
“Other companies working on coronavirus vaccines have followed the same line, collecting billions in government grants, hoarding patents, revealing as little as possible about their deals — and planning to charge up to $37 a dose for potentially hundreds of millions of shots.”
All of this tells you that the same greed that drove these drug companies into criminal acts before is still at play today, and they have repeatedly proven that profit potential wins over harm potential every time.
Leaked Data Warns of mRNA Instability
A recent feature investigationfn29 BMJ 2021;372:n627 by journalist Serena Tinari published in The BMJ reviews the content of leaked — possibly hacked — documents showing the European Medicines Agency (EMA) had concerns about early batches of the Pfizer vaccine having lower than expected levels of intact mRNA:
“EMA scientists tasked with ensuring manufacturing quality — the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA — worried about ‘truncated and modified mRNA species present in the finished product.’
Among the many files leaked to The BMJ, an email dated 23 November  by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two ‘major objections’ with Pfizer, along with a host of other questions it wanted addressed.
The email identified ‘a significant difference in % RNA integrity/truncated species’ between the clinical batches and proposed commercial batches — from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was ‘yet to be defined,’ the email said.”
Considering the delivery of intact mRNA is of crucial importance for the efficacy of this vaccine, the suspicion is that the lower levels might render the vaccine ineffective.
One problem is that while the EMA has authorized Pfizer’s vaccine and issued a public assessment stating the quality is “considered to be sufficiently consistent and acceptable,” it’s not clear if and how the agency’s concerns about inadequate mRNA levels were actually corrected.
The EMA has explained away the issue by stating that some of the leaked information was “partially doctored” by essentially cutting and pasting data from different users into valid emails.
“But the documents offer the broader medical community a chance to reflect on the complexities of quality assurance for novel mRNA vaccines,” Tinari writes, “which include everything from the quantification and integrity of mRNA and carrier lipids to measuring the distribution of particle sizes and encapsulation efficiency.”
It’s well-recognized that RNA instability is of the utmost importance when it comes to this kind of technology, as even minor degradation anywhere along the RNA strand can slow the translation performance and result in the incomplete expression of the target antigen (in this case the SARS-CoV-2 spike protein).
One problem is there’s no regulatory guidance for mRNA based “vaccines.” Yet another problem is that the data currently available is so scant that regulators probably wouldn’t be able to make an appropriate assessment about the percentage of intact mRNA required for efficacy.
Lipid Nanoparticles Are Highly Inflammatory
mRNA fragility and instability is the reason why Pfizer and Moderna use a lipid nanoparticle delivery system, which brings a whole separate set of problems. Scientist and researcher Judy Mikovits, Ph.D., believes the nanoparticle allows the mRNA to escape the normal degradation by enzymes that normally remove mRNA, thereby allowing it to persist in your tissues for a long time, continuing to produce spike proteins all the while.
As previously suspected, researchfn30 BioRxiv March 4, 2021 DOI: 10.1101/2021.03.04.430128 posted March 4, 2021, on the preprint server bioRxiv now warns that the lipid nanoparticle component of these mRNA vaccines is in fact “highly inflammatory” and may be responsible for many of the side effects being reported. According to the authors:
“Vaccines based on mRNA-containing lipid nanoparticles (LNPs) are a promising new platform used by two leading vaccines … Clinical trials and ongoing vaccinations present with very high protection levels and varying degrees of side effects. However, the nature of the reported side effects remains poorly defined.
Here we present evidence that LNPs used in many preclinical studies are highly inflammatory in mice.
Intradermal injection of these LNPs led to rapid and robust inflammatory responses, characterized by massive neutrophil infiltration, activation of diverse inflammatory pathways, and production of various inflammatory cytokines and chemokines. The same dose of LNP delivered intranasally led to similar inflammatory responses in the lung and resulted in a high mortality rate …
Their potent adjuvant activity and reported superiority comparing to other adjuvants in supporting the induction of adaptive immune responses could stem from their inflammatory nature. Furthermore, the preclinical LNPs are similar to the ones used for human vaccines, which could also explain the observed side effects in humans using this platform.”
Can You Trust Big Pharma to Safeguard Your Health?
Considering their long histories of unethical, illegal and criminal behaviors, Pfizer, Johnson & Johnson and AstraZeneca are hardly beacons of hope for mankind when it comes to COVID-19 — or any other pandemic, for that matter.
Sadly, the rapidly escalating reports of serious side effects and deaths from these injections, and the companies’ dismissal of these events as coincidental or insignificant further prove that profit is still the primary driver. If they can make a buck by ignoring a problem, they will.
ORIGINAL SOURCE: Date-stamped: March 24, 2021 - Author: Analysis by Dr. Joseph Mercola - Article Title: Can You Trust Big Pharma’s Gene Therapy Vaccine? - Article Link: articles.mercola.com
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