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Saturday, May 15, 2021

Criminality and Informed Consent

 "As the sun does not wait for prayers and incantations to be induced to rise, but immediately shines and is saluted by all, so do you also not wait for clappings of hands and shouts of praise to be induced to do good, but be a doer of good voluntarily and you will be beloved as much as the sun." - Epictetus


 The title of this blog post includes two subjects that I want to discuss.  First up, criminality.

Three of the four companies manufacturing the most widely-available Covid-19 vaccines in the western world are criminal enterprises.  All of the below information comes from Wikipedia, and I'm just block-quoting.  If you don't agree these are criminal organizations, blame Wikipedia for presenting facts, not this blogger for repeating them.

 AstraZeneca: 

Seroquel

In April 2010, AstraZeneca settled a qui tam lawsuit brought by Stefan P. Kruszewski for US$520 million to settle allegations that the company defrauded Medicare, Medicaid, and other government-funded health care programs in connection with its marketing and promotional practices for the blockbuster atypical antipsychotic, Seroquel. According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.[108]

In March 2011, AstraZeneca settled a lawsuit in the United States totalling US$ 68.5 million to be divided up to 38 states.[109]

 Johnson and Johnson.

In December 2018, with 11,700 people suing J&J over cancers allegedly caused by baby powder, the company was forced to release internal documents. The documents showed that the company had known about asbestos contamination since at least as early as 1971 and had spent decades finding ways to conceal the evidence from the public.

Also:

By 2018, the company had become embroiled in the opioid epidemic in the United States and had become a target of lawsuits.[212][213] Over 500 opioid-related cases have been filed as of May 2018 against J&J and its competitors.[214] In Idaho, J&J is part of a lawsuit accusing the company for being partially to blame for opioid-related overdose deaths.[215] The first major trial began in Oklahoma in May 2019.[216] On August 26, 2019, the Oklahoma judge ordered J&J to pay $572 million for their part in the opioid crisis,[217] and in October J&J paid $20.4 million to two Ohio counties fighting the opioid epidemic.[218]

Also:

In 2011, J&J settled litigation brought by the US Securities and Exchange Commission under the Foreign Corrupt Practices Act and paid around $70M in disgorgement and fines.[179] J&J's employees had given kickbacks and bribes to doctors in Greece, Poland, and Romania to obtain business selling drugs and medical devices and had bribed officials in Iraq to win contracts under the Oil for Food program.[180] J&J fully cooperated with the investigation once the problems came to light.[181]

Pfizer:

Illegal marketing of gabapentin for off-label uses

In 1993, the Food and Drug Administration (FDA) approved gabapentin only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used continuing medical education and medical research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for off-label uses such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.[168] In 2004, the company paid $430 million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the False Claims Act.[169] A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.[170] The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence.[171]

Illegal marketing of Bextra

In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. Pfizer promoted the sale of the drug for several uses and dosages that the Food and Drug Administration specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005.[172][173] It was Pfizer's fourth such settlement in a decade.[174][175][176] The payment included $1.3 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration (FDA) leading to violations under the False Claims Act as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date.[173][174][175][176] Pfizer entered a corporate integrity agreement with the Office of Inspector General that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.[177]

Termination of Peter Rost

Peter Rost was vice president in charge of the endocrinology division at Pharmacia before its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him employed, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.[178][179]

Illegal marketing of Rapamune

A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer in 2009, alleging that the company illegally marketed sirolimus (Rapamune) for off-label uses, targeted specific doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to change from their transplant drugs to Rapamune, and specifically targeted African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals that prescribed the drug with kickbacks such as grants, donations, and other money.[180] In 2013, the company pleaded guilty to criminal mis-branding violations under the Federal Food, Drug, and Cosmetic Act. By August 2014, it had paid $491 million in civil and criminal penalties related to Rapamune.[181]

Illegal marketing

In June 2010, health insurance network Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing drugs Bextra, Geodon and Lyrica. BCBS alleged that Pfizer used kickbacks and wrongly persuaded doctors to prescribe the drugs.[182][183] According to the lawsuit, Pfizer handed out 'misleading' materials on off-label uses, sent over 5,000 doctors on trips to the Caribbean or around the United States, and paid them $2,000 honoraria in return for listening to lectures about Bextra.[184][185] Despite Pfizer's claims that "the company's intent was pure" in fostering a legal exchange of information among doctors, an internal marketing plan revealed that Pfizer intended to train physicians "to serve as public relations spokespeople."[186] The case was settled in 2014 for $325 million.[187] Fearing that Pfizer is "too big to fail" and that prosecuting the company would result in disruptions to Medicare and Medicaid, federal prosecutors instead charged a subsidiary of a subsidiary of a subsidiary of Pfizer, which is "nothing more than a shell company whose only function is to plead guilty."[186]

Removal of ads after unflattering article

According to Harper's Magazine publisher John R. MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from Harper's Magazine following an unflattering article on depression medication.[188]

Quigley Company asbestos

The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. In June 2013, asbestos victims and Pfizer negotiated a settlement that required Pfizer to pay a total of $964 million: $430 million to 80% of existing plaintiffs and place an additional $535 million into a settlement trust that will compensate future plaintiffs as well as the remaining 20% of plaintiffs with claims against Pfizer and Quigley. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million is from insurance policies.[189]

Shiley defective heart valves

Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley valve. Approximately 500 people died when defective heart valves fractured and, in 1994, Pfizer agreed to pay $10.75 million to settle claims by the United States Department of Justice that the company lied to get approval for the valves.[190]

Firing of employee that filed suit

A federal lawsuit was filed by a scientist claiming she got an infection by a genetically modified lentivirus while working for Pfizer, resulting in intermittent paralysis.[191] A judge dismissed the case citing a lack of evidence that the illness was caused by the virus but the jury ruled that by firing the employee, Pfizer violated laws protecting freedom of speech and whistleblowers and awarded her $1.37 million.[192]

Celebrex intellectual property

Brigham Young University (BYU) said a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led towards development of Celebrex. BYU was originally seeking a 15% royalty on sales, equating to $9.7 billion. A research agreement had been made between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems and Celebrex is used to reduce those issues. A six-year battle ensued because BYU claimed that Pfizer did not give Dr. Simmons credit or compensation, while Pfizer claimed that it had met all obligations regarding the Monsanto agreement. In May 2012, Pfizer settled the allegations, agreeing to pay $450 million.[193]

Nigeria Trovafloxacin lawsuit

In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children.[194] Local Kano officials reported that more than fifty children died in the experiment, while many others developed mental and physical deformities.[195] The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa.[196] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[197] According to Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[198] The lawsuits also accused Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Nigerian medical personnel as well as at least one Pfizer physician said the trial was conducted without regulatory approval.[199][200]

In 2007, Pfizer published a Statement of Defense letter.[201] The letter stated that the drug's oral form was safer and easier to administer, that Trovan had been used safely in more than five thousand Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after four weeks.

In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[202]

In December 2010, a United States diplomatic cables leak was released by WikiLeaks indicating that Pfizer hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[203] The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail".[198] In response, the company released a press statement describing the allegations as "preposterous" and saying that it acted in good faith.[204] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[205] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[206][207]

Environmental record

Since 2000, the company has implemented more than 4,000 greenhouse gas reduction projects.[208]

In 2012, the company was named to the Carbon Disclosure Project's Carbon Leadership Index in recognition of its efforts to reduce greenhouse gas emissions.[209]

Pfizer has inherited Wyeth's liabilities in the American Cyanamid site in Bridgewater Township, New Jersey, a highly toxic EPA Superfund site. Pfizer has since attempted to remediate this land in order to clean and develop it for future profits and potential public uses.[210] The Sierra Club and the Edison Wetlands Association have opposed the cleanup plan, arguing that the area is subject to flooding, which could cause pollutants to leach. The EPA considers the plan the most reasonable from considerations of safety and cost-effectiveness, arguing that an alternative plan involving trucking contaminated soil off site could expose cleanup workers. The EPA's position is backed by the environmental watchdog group CRISIS.[211]

In June 2002, a chemical explosion at the Groton plant injured 7 people and caused the evacuation of more than 100 homes in the surrounding area.[212]

Political lobbying

Pfizer is a member of the U.S. Global Leadership Coalition, a Washington D.C.-based coalition of more than 400 major companies and NGOs that advocates for a larger International Affairs budget, which funds American diplomatic, humanitarian, and development efforts abroad.[213]

In the first nine months of 2009, Pfizer spent over $16.3 million lobbying members of the United States Congress, making it the 6th largest lobbying interest in the US (following Pharmaceutical Research and Manufacturers of America, which ranked 4th but also represents Pfizer interests). A spokeswoman for Pfizer said the company "wanted to make sure our voice is heard in this conversation" in regards to the company's expenditure of $25 million in 2010 to lobby health care reform.[214]

According to United States Department of State cables released by WikiLeaks, Pfizer "lobbied against New Zealand getting a free trade agreement with the United States because it objected to New Zealand's restrictive drug buying rules and tried to get rid of New Zealand's former health minister", Helen Clark, in 1990.[215]

Scott Gottlieb, who resigned as FDA commissioner in April 2019, joined the Pfizer board of directors three months later, in July 2019.[216]

That's a lot crime!!!  It's not critical to read and understand all of it.  The important thing to recognize is that these companies are primarily money-making enterprises.  They occasionally engage in criminal activity, and are not that interested in your health and well-being. 

If these companies were a person, they would be in jail.  Sadly the government seems unwilling to prosecute the *individuals* at these companies who are responsible for the illegal activity.  Instead, law enforcement agencies fine these companies.  This punishes the *stockholders* - people who were unaware and uninvolved with the criminal activity!!!  This is insane.

It also shows how corrupt federal law enforcement is.  They don't pursue these pharma-criminals with the same determination as a guy who held up a convenience store for $20.  There is no comparing the widespread damage and death caused by pharmaceutical crimes to a 30 second robbery.  The guy committing a robbery will probably have five additional charges filed against him, including running a red light.  These pharmaceutical crooks get off with a fine - which is applied to someone else.

I'm letting Moderna off the hook - That company is just 10 years old, and doesn't seem to have had any major brushes with regulators.  So - like I said at the beginning, three of the four pharmaceutical companies manufacturing the major western Covid-19 vaccines are criminal enterprises.  This is a well-documented fact.

Now let's discuss the second idea:  The notion of informed consent.  

At its most basic, "Informed Consent" is the process where a patient is educated on the treatment that the physician is recommending, and then is able to make an "informed" decision whether or not to undergo the treatment.

"Informed Consent" is the reason why, when you get a prescription, the pharmacist asks if you want a consultation on the drug they are dispensing.  It's why there is bundled paperwork with the prescription, explaining side effects, warnings, dosing, when to seek medical help, etc, etc, etc.  This is to provide you with enough knowledge that you can make an informed decision about whether to take the medicine.  You know exactly what you are getting into by taking the drug.

You get the same information in abbreviated form with over-the-counter drugs like cold medicines, antihistamines, acid regulators, and pain relievers.  But you don't really get that much information with these vaccines.

However, because the Covid-19 vaccines are "Emergency Use Authorization", the process isn't quite the same.  Below is a block-quote from the CDC website.

COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers

For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination. This is accomplished by providing an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content to vaccine information statements (VISs) for licensed vaccines but differs in that the EUA Fact Sheet is specific to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by the FDA.

There is no VIS for COVID-19 vaccines authorized under an EUA. Instead, the FDA-issued EUA Fact Sheet for Recipients and Caregivers for each COVID-19 vaccine must be used.

To help facilitate documentation of having provided the EUA Fact Sheet in electronic medical records/immunization information systems, CDC is leveraging the existing VIS Code Set infrastructure, barcoding, and URLs to provide the information needed for various systems, analogous to electronic system and workflow documentation of VISs.

It is important to note again that although CDC’s VIS Code Set files are used to convey the codes for EUA Fact Sheets for Recipients and Caregivers, these Fact Sheets are distinct from VISs. VISs will become available when there are licensed COVID-19 vaccines.

Thus far, the codes and URL links to access the EUA Fact Sheet documents have been developed for the following current and potential COVID-19 EUA vaccines:

The AstraZeneca link is (as of 5 March 2021) dead.  I've read the others, and they are all similar to one another.  You may have this side effect, you may have that side effect.  If you have a side effect, do this.

It should be noted that all of the side effects mentioned are acute - stuff that happens to a patient within a short time after receiving a dose of the vaccine.  Nobody yet knows what the long-term effects may be, and whether those can be expected is not even addressed in the literature.

And this is where the informed consent issue arises in my mind:  These vaccines differ significantly from one another in manufacture and in adverse medical events, and yet the EUA consent forms are remarkably identical.  Is it really "informed" consent?  Is it semi-informed consent?  Is just the pretense of informed consent?  Only time will tell.  

It doesn't put my mind at ease that these criminal organizations have already been released from legal liability in advance.  It's not like they had any ethics even when the law (theoretically) applied to them. 

I recently came across this interesting bit of research:  Link to article is here.  I will quote and underline the fascinating parts.

Scientists have known for a while that SARS-CoV-2's distinctive "spike" proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that they also play a key role in the disease itself.

The paper, published on April 30, 2021, in Circulation Research, also shows conclusively that COVID-19 is a vascular disease, demonstrating exactly how the SARS-CoV-2 virus damages and attacks the vascular system on a cellular level. The findings help explain COVID-19's wide variety of seemingly unconnected complications, and could open the door for new research into more effective therapies.

"A lot of people think of it as a respiratory disease, but it's really a vascular disease. That could explain why some people have strokes, and why some people have issues in other parts of the body. The commonality between them is that they all have vascular underpinnings."

Uri Manor, Study Co-Senior Author and Assistant Research Professor

In the new study, the researchers created a "pseudovirus" that was surrounded by SARS-CoV-2 classic crown of spike proteins, but did not contain any actual virus. Exposure to this pseudovirus resulted in damage to the lungs and arteries of an animal model--proving that the spike protein alone was enough to cause disease.

OK, I am not a biologist, don't pretend to be one, and don't understand half of this crap.  But that last sentence scares me.  I also know this:  The vaccines for some reason all have chosen to target the spike protein, and (if I understand this correctly) use chunks of the spike protein (or mRNA to trick the body into making spike proteins) to activate the immune system.  

So now I have a question:  Are the vaccines inadvertently causing vascular damage by injecting the spike protein in the form of vaccine?  If there are any smart people who understand this stuff and happen by, I'd certainly appreciate a non-evasive answer.

And lastly, I urge you to read this blog post at "The Automatic Earth".  The author asks whether we are really "following the science", and he puts it better than I *ever* could.


 

 

 

 

1 comment:

Marc said...

I've read Pfizer stands to profit over $900 billion through all this. Not sure about the other vaccine producers. Basically, what some already know, follow the money. If you've not already done so, watch some of the youtube videos by Dr. Ryan Cole, MD. He has a lab in Boise (Garden City). An interesting write-up, and one I enjoyed reading.