By Guy Hatchard | TCW Defending Freedom | September 9, 2022
The writer is in New Zealand.
TWO and a half years into the Covid saga, the public is still faced with an information blackout. The data is very concerning indeed, but no one in parliament or the MSM wants to get in front of it. Instead many are still stuck stoking the fear factor. As Professor Vinay Prasad, an American haematologist-oncologist and health researcher, wrote a few days ago: ‘Legitimising irrational anxiety is bad medicine’.
Early on in our efforts to publicise the dangers of biotechnology medicine, I had an email exchange with Jesse Mulligan, a popular commentator with RNZ Afternoons. His perspective on Covid vaccination was as follows.
December 6, 2021: ‘I feel like anybody aiming to critique such an obviously positive public health measure should begin and end their messaging reminding people that any risks/flaws in the vaccine are minor compared to the horrific impacts of getting Covid . . . I don’t have the time to correspond with you on this at length but, for what it’s worth, if you’re putting people off getting a largely safe vaccine by what you’re writing about it, I think you need to review how you approach writing these messages.’
Mulligan quoted from Ministry of Health directives and had also read some questioning scientific articles, but he could not get past the conclusion that vaccination was an obvious public good and for this reason he declined to have me on his show.
The ‘obvious public good’ narrative has come in for some recent criticism. The BMJ printed an opinion piece in July entitled Time to assume that health research is fraudulent until proven otherwise? Or try this referenced substack article which reports that the negative harm/benefit ratio in the Moderna and Pfizer vaccine trials has been acknowledged in a scientific journal article. In other words there is more harm than benefit.
For me, the central early point of pandemic misinformation has been the underlying assumption that biotech medicine interventions could be safe. There really was little or no evidence to justify such an attitude, in fact, as I have discussed, there was a great deal of published pre-pandemic evidence to justify caution.
Given the central role of DNA in human physiology, altering its function was from the outset potentially catastrophic. We are now facing Covid vaccine outcomes which not only involve serious individual adverse effects, but also potentially affect whole populations into the longer term. These outcomes include:
· Elevated excess all-cause death rates and lowered longevity
· Lowered birth rates and fertility
The evidence for these is patchy because governments are not rushing to publish data, but it is still very convincing. So concerning in fact, that the Israeli government has covered up key data and scientific conclusions.
The latest comprehensive evidence for Covid vaccine-induced excess all-cause mortality can be found in this analysis: Excess mortality in Germany 2020-2022.
It is extraordinary that this perilous new normal has found its way into advertising messages, but not into serious commentary. Today I watched a TV ad for a funeral home which arranges alternative and appropriate funerals for those dying young, whilst a British Heart Foundation appeal featured a young woman collapsing on the football field. It did so to encourage donations.
Sudden deaths among all ages are being normalised in the public’s mind because they really are happening at a rate that dwarfs the past, as insurance data confirms. However here in New Zealand we are still being subjected to puerile government advertising devoid of scientific caution. Like this Ministry of Health promotion which turned up this morning:
GET YOUR SECOND BOOSTER – I’ve had three shots, do I really need another booster? Current evidence shows your protection against severe infection slowly decreases over time – GET YOUR SECOND BOOSTER
No mention of safety, no mention of efficacy, and the term ‘current evidence’ used as if this advert is scientifically up to date and reliable. It isn’t.
Why is it so unfashionable to be concerned about rising death rates and lowered birth rates? You might find a clue in this frightening pre-pandemic article from the government-owned Canadian Broadcasting Corporation Medically assisted deaths could save millions in health care spending: Report. Are higher death rates good news for people with this kind of perspective? We hope not.
We are clearly on a learning curve here. The poor vaccination outcomes were not anticipated, the adverse effects were initially disbelieved on principle and blamed on misinformation.
It is understandable that in the uncertain early days of Covid, people [trusted] the official MoH narrative, but continuing to do so now doesn’t fit the published scientific narrative or the public data. Caution was and is a very scientific strategy, it never deserved bad press.
Those offering advice to the public need to be more discerning if they wish to contribute to the well being and longevity of our society. MSM language has become extreme, and it is increasingly polarising without foundation in science.
There is still a chance for journalists to cover the pandemic with an open mind. It is happening elsewhere. GB News for example has gained one of the largest prime-time news audiences in the UK. Why not initiate a more open public debate? Cooling rhetoric and decreasing polarisation can only lead to better outcomes. Fresh air never harms anyone – it can save lives.
By Suzanne Burdick, Ph.D. | The Defender | September 9, 2022
A Wisconsin hospital this week said it is withdrawing medical and religious exemptions for some employees from the hospital’s COVID-19 vaccine mandate, giving those employees until Sept. 21 to get the Novavax vaccine.
Froedtert & the Medical College of Wisconsin, which operates 11 hospitals and more than 45 health centers and clinics throughout the midwest and employs more than 2,000 physicians, in an email said the Novavax vaccine option “eliminates conflicts” for those who originally declined COVID-19 vaccination for religious or medical reasons.
The U.S. Food and Drug Administration in July granted Emergency Use Authorization of the Novavax COVID-19 vaccine for adults ages 18 and up. While the prior COVID-19 vaccines made by Pfizer, Moderna and Johnson & Johnson used fetal cell lines from unborn fetuses in various stages of development and testing, the Novavax vaccine is made differently and does not use human fetal cell lines.
Froedtert employees who don’t get the first Novavax dose by Sept. 21 will be terminated as Froedtert will consider them to have “voluntarily resigned,” the company said.
The hospital said in a statement:
“Froedtert Health requires staff and providers be fully vaccinated against COVID-19 as a federal requirement that is monitored for compliance. We join many other health systems around southeast Wisconsin and the U.S. that have made vaccination a condition of employment.
“The Novavax vaccination for COVID-19 is now available. This protein-based vaccination option eliminates conflicts for those staff with religious or medical exemptions caused by mRNA-based vaccines and other concerns.
“Since those staff are now eligible for a vaccination that does not conflict with their religious beliefs or medical situation, their exemption will expire. This affects a small percentage of staff with a vaccine exemption. Eligible staff continue to be exempt from a COVID-19 vaccine for religious and medical reasons.
“Froedtert Health respects the right of staff and providers to engage in activity protected by state and federal law.”
A Froedtert employee who spoke anonymously to WISN 12 News on Wednesday said Froedtert’s abrupt demand will have negative repercussions.
“Anyone in healthcare knows we’re very understaffed and overworked right now and this is just going to take away a lot of nurses from the bedside,” she said. “This will affect patient care and safety.”
Although according to Froedtert, as of October 2021 — their most recent count — nearly 99% of their employees had been vaccinated against COVID-19, the employee said she thought about 100 nurses would be affected.
The employee, a Catholic, said the previous vaccines were against her religious beliefs because of the ingredients. However, the Novavax vaccine also goes against her religious beliefs, she said.
“Now that we’re two, almost three years into this [COVID-19 pandemic] and we know more, we should be able to make our own educated decision,” she said.
She added:
“It’s my body, my temple. God is within us. If we’re uncomfortable, or not sure about something, then we shouldn’t do it.”
The employee said she’s presently unsure what she will do.
“I carry the health insurance for our family. I have a week to decide if I feel comfortable taking this vaccine otherwise I honestly don’t know. I don’t know if any other healthcare facilities in this area even take exemptions,” she said.
Froedtert officials said their recent exemption withdrawal complies with federal regulations that mandate all employees must be vaccinated against COVID-19 or have legitimate religious or medical exemptions.
Mark Goldstein, an employment lawyer, told WISN 12 News employees affected by the mandate could “attempt to recast their religious exemption as a more generalized claim.”
“Quite frankly,” he added, “some of it depends on how strident they are in that regard.”
The hospital’s requirement is that employees be fully vaccinated against COVID-19, but not that they have to get the new Omicron-specific booster shot made by Pfizer and Moderna.
Novavax pushed on unvaccinated despite safety concerns
As The Defender reported in late July when the Centers for Disease Control and Prevention (CDC) recommended the Novavax COVID-19 vaccine for adults age 18 and up, Operation Warp Speed in 2020 awarded Novavax — which like Moderna, had never brought a product to market before COVID-19 — a secret contract worth $1.6 billion (now being reported as $1.8 billion).
It was one of the largest taxpayer handouts channeled through Operation Warp Speed.
The media characterized the Novavax injection as a “game changer” in comparison to the mRNA and adenovirus-vectored gene therapy shots, claiming it should be “reassuring to those who are hesitant.”
In fact, according to the CDC’s advisors, the unvaccinated represent the “primary target population for Novavax.”
Some media outlets claimed Novavax — made with recombinant moth-cell-based nanoparticle technology, the problematic surfactant polysorbate 80 and a never-before-approved nanoparticulate adjuvant called Matrix-M — is “free of side effects.”
However, the day after the FDA issued its Novavax authorization, the European Medicines Agency (EMA) updated its product information for the Novavax shot to disclose “new” side effects.
The EMA’s list of side effects included “severe allergic reaction [anaphylaxis] and unusual or decreased feeling in the skin” (called paresthesia and hypoesthesia, respectively).
In addition, the EMA said it would assess myocarditis and pericarditis as Novavax side effects — safety signals that also were on display in the FDA’s briefing document on Novavax.
And in clinical trials, older adults who received the Novavax vaccine experienced an increased incidence of hypertension compared to those in the placebo group.
Not as ‘traditional’ as portrayed
The Novavax vaccine relies on a protein-based technology used for decades, leading some media outlets to portray it as a “traditional” vaccine compared with other COVID-19 vaccines that use newer technologies.
But according to Dr. Meryl Nass, an internist with a special interest in vaccine-induced illnesses, chronic fatigue syndrome and toxicology, the media’s portrayal of Novavax as a more traditional vaccine is not accurate.
Nass, a member of the Children’s Health Defense (CHD) scientific advisory committee, pointed out that the Novavax shot contains a novel adjuvant, Matrix-M, “so it is not really an old-fashioned shot.”
Nass raised safety concerns specific to the adjuvant, while others voiced concerns about Novavax being linked to heart inflammation and blood clots, and the fact that the vaccine was designed for use against the original Wuhan strain of SARS-CoV-2 — not the Omicron variants that are dominant today.
Adjuvant used in Novavax linked to autoimmune disease
Because Novavax is a protein subunit vaccine, it uses just the spike protein as the antigen rather than the whole pathogen (an inactivated or attenuated virus). Using the whole pathogen would expose the host to the virus’ entire protein coat instead of just one protein.
Protein subunit vaccines are often less immunogenic (less likely to provoke the immune system) than vaccines that use whole pathogens as the antigen, and may not generate a strong enough immune response.
That’s why they require the use of an adjuvant — in this case, Matrix-M — in addition to the antigen to get a stronger immune response.
However, few adjuvants are both potent and non-toxic enough for clinical use.
The proposed primary series for Novavax is two intramuscular injections 21 days apart at the dose level of 5 µg of the recombinant spike protein and 50 µg of the Matrix-M adjuvant.
Matrix-M, originally called QS-21, was one of the saponins derived from Quillaja saponaria, which is the soap bark tree native to Chile.
Some reports point out that the Matrix-M adjuvant — unlike the polyethylene glycol (PEG) lipid used in mRNA vaccines — is not linked to anaphylaxis (a severe allergic reaction), making it more attractive to people who are allergic to PEG.
But according to Nass, while it’s true that Matrix-M — which is not found in any other vaccines in the U.S. — isn’t linked to anaphylaxis, it is linked to autoimmune diseases.
“While touted as a replacement for the PEG lipid found in the mRNA vaccine, Matrix-M is less likely to cause anaphylaxis but more likely to cause autoimmune diseases,” Nass said.
Nass voiced other safety concerns about Novavax technology, including the use of moth cells.
According to the University of Nebraska Medical Center, where Novavax Phase 3 clinical trials were conducted, the Novavax vaccine uses moth cells to create a nanotechnology version of the COVID-19 spike protein.
Nass said insect cells can be used to grow proteins rapidly. “There is one flu vaccine made the same way: Flublok,” Nass said. Flublok is one of two egg-free flu vaccines licensed for use in the U.S.
“How many insect and viral proteins or other molecules are being injected into you when you get the Novavax vaccine — which is a function of how purified the vaccine is — is unknown,” Nass said.
Novavax still uses the spike protein
The SARS-CoV-2 virus encodes 29 proteins, but Novavax — like Pfizer, Moderna and Johnson & Johnson — chose to target only the spike protein.
As previously reported in The Defender, it is not known if the spike protein itself is safe.
“We have known for a long time that the spike protein is a pathogenic protein,” said Byram Bridle, Ph.D., associate professor of viral immunology at the University of Guelph, Ontario. “It is a toxin. It can cause damage to our body if it gets into circulation.”
According to Brian Hooker, Ph.D., P.E., CHD’s chief scientific officer, “If you wanted to pick the most toxic protein, you know what represents the highest virulence, the highest amount of damage on the COVID-19 virus? You would pick the spike protein.”
The spike protein “has been consistently shown to create clotting issues in the blood,” Hooker said.
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa. She holds a Ph.D. in Communication Studies from the University of Texas at Austin (2021), and a master’s degree in communication and leadership from Gonzaga University (2015). Her scholarship has been published in Health Communication.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
BY WILL JONES | THE DAILY SCEPTIC | SEPTEMBER 10, 2022
Over 400 doctors, scientists and professionals from more than 34 countries this morning declared an international medical crisis due to “diseases and death associated with the ‘COVID-19 vaccines’”.
Launched at a press conference on Saturday, September 10th, the declaration states: “We are currently witnessing an excess in mortality in those countries where the majority of the population has received the so-called ‘COVID-19 vaccines’. To date, this excess mortality has neither been sufficiently investigated nor studied by national and international health institutions.”
It continues:
The large number of sudden deaths in previously healthy young people who were inoculated with these ‘vaccines’ is particularly worrying, as is the high incidence of miscarriages and perinatal deaths which have not been investigated.
A large number of adverse side effects, including hospitalisations, permanent disabilities and deaths related to the so-called ‘COVID-19 vaccines’, have been reported officially.
The registered number has no precedent in world vaccination history.
The declaration, which originates among concerned medics and professionals in India, makes eight “urgent” demands, including an immediate stop to the vaccinations and investigation of all deaths in previously healthy people.
Read the full text below, and if you are a doctor, scientist or other professional, do consider signing.
DECLARATION OF INTERNATIONAL MEDICAL CRISIS DUE TO THE DISEASES AND DEATHS CO-RELATED TO THE ‘COVID-19 VACCINES’
We, the medical doctors and scientists from all over the world, declare that there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as ‘COVID-19 vaccines’.
We are currently witnessing an excess in mortality in those countries where the majority of the population has received the so-called ‘COVID-19 vaccines’. To date, this excess mortality has neither been sufficiently investigated nor studied by national and international health institutions.
The large number of sudden deaths in previously healthy young people who were inoculated with these ‘vaccines’, is particularly worrying, as is the high incidence of miscarriages and perinatal deaths which have not been investigated.
A large number of adverse side effects, including hospitalisations, permanent disabilities and deaths related to the so-called ‘COVID-19 vaccines’, have been reported officially.
The registered number has no precedent in world vaccination history.
Examining the reports on CDC’s VAERS, the U.K.’s Yellow Card System, the Australian Adverse Event Monitoring System, Europe’s EudraVigilance System and the WHO’s VigiAccess Database, to date there have been more than 11 million reports of adverse effects and more than 70,000 deaths co-related to the inoculation of the products known as ‘Covid vaccines’.
We know that these numbers just about represent between 1% and 10% of all real events.
Therefore, we consider that we are facing a serious international medical crisis, which must be accepted and treated as critical by all states, health institutions and medical personnel worldwide.
Therefore, the following measures must be undertaken on an urgent basis:
Consequently we declare that we find ourselves in an unprecedented international medical crisis in the history of medicine, due to the large number of diseases and deaths associated with the ‘vaccines against COVID-19’. Therefore, we demand that the regulatory agencies that oversee drug safety as well as the health institutions in all countries, together with the international institutions such as the WHO, PHO, EMA, FDA, UK-MHRA and NIH respond to this declaration and act in accordance with the eight measures demanded in this manifesto.
This Declaration is a joint initiative of several professionals who have been fighting for this cause. We call on all doctors, scientists and professionals to endorse this statement in order to put pressure on the entities involved and promote a more transparent health policy.
By David Bell and Domini Gordon | PANDA | August 28, 2022
Medical ethics is about protecting society from medical malfeasance and the self-interest of the humans whom we trust to manage health. It is therefore disturbing when prominent people, in a prominent journal, tear up the concept of medical ethics and human rights norms. It is worse when they ignore broad swathes of evidence, and misrepresent their own sources to do so.
On July 8th 2022, The Lancet published a ‘Viewpoint’ article online: “Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA.” The article, which acknowledges the controversial nature of vaccine mandates, primarily concludes that coercing people to take a medical product, and reducing options for refusal, increases product uptake.
It further concludes that the best way to implement such mandates is for employers and educational institutions to threaten job security and the right to education.
The use of coercion goes against the established ethics and morals of Public Health, and could be argued to be anti-health. In this case, the article justifies it by stating that “the current evidence regarding the safety of COVID-19 vaccines in adults is sufficient to support mandates.” However, it offers scant evidence to back this assertion, and ignores all evidence to the contrary. They apparently consider the ability to work and support a family, or gain formal education, as something that is to be granted or taken away, not a human right.
The Lancet was once a credible journal with a rigorous policy of peer review. However, in this article it appears to have dropped its former standards, promoting medical fascism (coercion, threat and division to achieve compliance with authority) without insisting on a rigorous evidence base to justify such an approach. This suggests an attempt to normalize such approaches in mainstream public health.
Past experience has shown us where fascism behind a façade of public health can lead. The sterilization campaigns aimed at coloured and low-income populations of the US Eugenicist era, and the extensions of similar programs under Nazism in 1930s and 1940s Europe, relied heavily on the normalization of such approaches.
Leading public health voices from Johns Hopkins School of Public Health and other institutions championed a public health approach of sanitizing populations rather than environments, encouraging the idea of a tiered society where health ‘experts’ determine the rights and medical management of those deemed less worthy.
Avoiding the discomfort of evidence
The authors of this Lancet paper, ranging from academics and medical consultants to the daughter of a prominent politician, attempt to rewrite human rights in medicine as if precedent never existed. Their argument for coercion in mass vaccination recognizes that ‘vaccine mandates,’ whether issued by governments, employers or schools, all involve a loss of rights. No serious attempt is made to provide a medical justification for mass vaccination with a non-transmission-blocking vaccine.
The paper focuses on the premise that coercion, commonly considered a form of force, makes humans do things they would not otherwise do. Banning fellow humans from making their own health choices on pain of loss of normal participation in society has an impact on increasing vaccine uptake. This is hardly a revelation to any thinking human, but clearly important enough to justify publication in The Lancet.
The article links to evidence of vaccine mandates used for state school entry that show higher compliance when the right of religious and personal belief exemption is removed, or where onerous requirements for exemptions are put in place. Leaving ethical questions aside, the obvious lack of similarity between the authors’ predicate childhood vaccinations that block transmission and COVID-19 vaccines that have minimal impact on transmission, and may even promote it, is ignored. The one mandated adult vaccine predicate referenced in the article, the influenza vaccine, provides only a 2.5% reduction in pneumonia ‘when the (mandated) vaccine was well matched to circulating strains’ in the reference quoted.
When raising the sacking of non-vaccinated workers, the authors seem comfortable with the approach but coy in admitting its consequences. Their admission that “a few large US employers have terminated hundreds of workers for non-compliance references an article in Money magazine which actually paints a bleaker picture, characterizing it as a ‘great resignation.’
The authors will also have been aware of mass layoffs by large employers such as New York City (over 9,000 sacked or placed on leave), the US Department of Defense (DoD, which sacked 3,400), Kaiser Permanente (laid off 2,200), and the tens of thousands of staff lost from the UK care-home sector . Extrapolated across countries and society to actually provide credible data may have been too uncomfortable for the authors and Lancet editors.
High efficacy and safety are an obvious (though on their own, insufficient) prerequisite for any mandated product. This entire area of safety is dealt with by stating; “The current evidence on the safety of COVID-19 vaccines in adults is sufficient to support mandates,” supported by a single study comparing vaccinated individuals 1-3 weeks and 3-6 weeks post-vaccination, revealing low levels of myocardial infarction, appendicitis and stroke.
The claim that “widespread administration in adults has quickly generated a large evidence base supporting the vaccines’ safety, including evidence from active surveillance studies” suggests that both the authors and The Lancet are unaware of the VAERS and Eudravigilance databases set up for exactly this purpose. No mention is made of growing data on myocarditis, menstrual irregularities, or the excess all-cause mortality and severe outcomes in vaccinated groups in the Pfizer randomised control trials on which the FDA emergency registration was based. Were The Lancet’s reviewers unaware of these sources?
The sole reference to vaccine efficacy discusses COVID-19 ventilated patient outcomes, It ignores the period to 14 days post-previous dose that Pfizer acknowledges can be associated with immune suppression. Fenton et al. have noted that classing a vaccinated person as unvaccinated in the first 14 days post-injection has profound impacts on vaccine effectiveness data.
Ignoring the awkwardness of reality
Post-infection immunity in the unvaccinated is a threat to arguments for mandates. The authors disingenuously state that “evidence suggests that the immunity produced by natural infection varies by individual, and that people with previous infection benefit from vaccination. New variants further undercut the case for adequacy of previous infection.
Two references are used here: one from a study in Qatar and the other a study from Kentucky. The Qatar study finds that “the protection of previous infection against hospitalization or death caused by reinfection appeared to be robust, regardless of variant,” whilst the Kentucky study found Covid reinfection was reduced by vaccination over a 2-month period in the months soon after vaccination, prior to the waning and then reversal of this protection as demonstrated in studies of longer duration elsewhere.
The vast breadth of evidence on relative effectiveness of post-infection immunity is ignored. Either the authors failed to read their references and are unaware of waning and of the vast literature on post-infection immunity, or they do not consider demonstration of efficacy important for coerced medical treatments.
In a previous era, or in a previously credible medical journal, an argument for coercion to support a medical procedure would have required very high standards of evidence of efficacy and safety. It is arguing for the abrogation of fundamental principles such as informed consent that are at the core of modern medical ethics. Failure to address well-known contrary data should prevent an article from even reaching the peer-review stage.
Degrading public health degrades society
We are left with a paper stating that coercion is a good path to increase compliance for a product that does not reduce community infection risk, and has potentially serious side effects. Ignoring both of these aspects of COVID-19 vaccines is a poor approach to justifying mass vaccination. The sole nod to any human rights concern – “Some objectors argue mandates represent undue encroachment on individual liberty” – is an interesting way to characterize removal of the right to income, education and the ability to socialize with others.
Although all these rights are recognized under the Universal Declaration for Human Rights, the authors and The Lancet consider them insufficiently serious to dwell upon.
Public health has been down this road before. We have seen the path society takes when basic public health principles are subverted to achieve an aim that some perceive as ‘good.’ We have also seen how most health professionals will comply, however horrific the actions involved. There is no reason to believe that this round of medical fascism will end differently.
We rely on medical journals such as The Lancet to apply at least the same standards to the purveyors of such doctrines as they do to others and demand a rational and honest evidence base. Anything less would raise legitimate questions as to the role the journal is taking in promoting these doctrines, and their place in a free, evidence-based and rights-respecting society.
David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is the former Program Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland.
Domini Gordon is Open Science and Open Society Coordinator at Panda.
The Defender | September 9, 2022
In early September, the U.S. Department of Justice (DOJ) announced that pharma giant Bayer would have to fork over millions to the DOJ to resolve allegations of fraud under the False Claims Act (FCA).
The False Claims Act, which enables civil cases involving fraud and false claims against the government, dates back to the 19th century and Civil-War-era defense contractor fraud — but in modern times, healthcare fraud is the “top driver of FCA activity, both in the number of cases filed and total dollars recovered.”
In fiscal year 2021 — a year in which medicine and pharma went to town with demonstrably murderous COVID-19 hospital protocols and vaccines — the act brought in $5.6-plus billion, the second largest annual total in the FCA’s history.
Eighty-nine percent of those settlements and judgments were related to “drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians.”
And, though the total amounts were smaller in the three preceding years — fiscal years 2020, 2019 and 2018 — healthcare-related cases still predominated, accounting for 86% to 87% of settlements and judgments.
In 2016, and again in 2019, the consumer advocacy organization Public Citizen zeroed in on “ongoing, systematic wrongdoing” by the pharmaceutical industry, analyzing up to 27 years (1991-2017) of criminal and civil penalties paid to the federal or state governments, whether via the FCA or other mechanisms.
The top two types of violations were drug-pricing fraud and unlawful or deceptive marketing. But the reports also described practices such as kickbacks, patent manipulation, corporate collusion, data concealment, sale of contaminated or adulterated products, accounting and tax fraud, insider trading and distribution of unapproved drugs.
In 2020, academic authors published a similar analysis in the Journal of the American Medical Association, reporting that 22 of 26 Global 500 or Fortune 1000 pharmaceutical firms had paid state or federal penalties for illegal activities between 2003-2016, with all but one firm engaging in the illegalities “for 4 or more years.”
The authors speculated that the four companies not documented as paying penalties could be more ethical or, conversely, might harbor “an ability for illegal activity to be undetected.”
All of these reports support the conclusion of Marc Rodwin — a Suffolk University Law School professor and expert on health law, policy and ethics — who wrote in a 2015 legal paper that the pharmaceutical industry’s “wide-scale” misconduct “risks slipping into the banalities of ordinary business practices.”
Bayer’s drop in the bucket
Bayer’s just-announced $40-million DOJ settlement, which responds to whistleblower lawsuits initiated nearly two decades ago, represents a drop in the bucket compared to the company’s $48.9-billion earnings for 2021.
The Germany-headquartered company, the world’s sixth-largest pharmaceutical juggernaut, is engaged in an ongoing biotech “investment spree” that has enabled positive financial results despite the current legal headaches associated with its ownership of Monsanto.
Violation Tracker, a database covering corporate misconduct from the year 2000 on, displays 155 results for Bayer and its subsidiaries over the past two decades, listing penalties such as drug and medical equipment safety violations, FCA offenses and various other forms of fraud.
The company’s “history of malfeasance” extends much further back, however, featuring its marketing of heroin as a top-selling children’s cough syrup in the early 20th century; the sale of lethal chemical weapons during WWI in violation of chemical warfare treaties; collaboration, as part of the IG Farben conglomerate, with Nazi medical experiments during WWII; knowingly marketing tainted blood products in the 1970s and 1980s; and, for 16 years, promoting a now-recalled birth control device — the focus of nearly 20,000 lawsuits — that routinely perforated women’s internal organs.
The long-running lawsuits that led to the latest settlement alleged Bayer paid kickbacks to hospitals and physicians to promote three drugs: a cholesterol drug recalled in 2001 after being linked to “significantly more fatal cases than its competitors,” a potent antibiotic associated with a wide range of serious or fatal adverse reactions and a kidney-toxic heart surgery drug approved in 1993 and belatedly recalled in 2007, after killing an estimated 22,000 bypass patients.
The whistleblower also alleged drug marketing “for off-label uses that were not reasonable and necessary” and significant downplaying of the two recalled drugs’ safety risks.
Though Bayer withdrew both drugs for “safety reasons,” its settlement admits no wrongdoing.
Top offenders since the early 1990s
In 1986, Congress amended the False Claims Act, significantly expanding its scope and “breath[ing] new life into what has now become the government’s primary enforcement tool against fraud.”
However, that same year President Ronald Reagan signed into law the National Childhood Vaccine Injury Act, a piece of legislation that decimated incentives to make vaccines safe by furnishing manufacturers with blanket immunity from liability for vaccine injuries.
The lifting of those legal constraints catapulted vaccines from a “neglected corner of the drugs business” into a major driver of pharmaceutical industry profits.
Public Citizen’s 1991-and-on analyses of settlements indicate these manufacturers also felt emboldened to engage in lawless — and recidivist — behavior even for drugs not enjoying liability protections.
According to Violation Tracker, Johnson & Johnson (J&J), Merck and Pfizer are the top three companies in terms of total penalties paid, with the latter two also accounting for the largest numbers of violations.
Among Pfizer’s penalties was a 2009 settlement for $2.3 billion — the largest healthcare fraud settlement in the DOJ’s history.
Merck and Pfizer happen to be two of the “big four” companies providing the vaccines on America’s childhood vaccine schedule, and J&J and Pfizer are responsible for two of the four COVID-19 shots authorized for U.S. use.
In 2021, Pfizer became the world’s largest pharmaceutical company, by revenue, thanks to its COVID-19 shots, also liability-free, and its Paxlovid drug. Together, Paxlovid and the vaccines accounted for almost half of operational revenues.
“Durable Covid-19 revenues” are fueling Pfizer’s expectation that it will remain a “growth company.”
Cui bono?
Although pharmaceutical industry kickbacks to hospitals and physicians are among the bad behaviors openly acknowledged to lead to settlements or judgments, few experts discuss, even indirectly, the fact that the penalties themselves function as a form of federal kickback.
Law professor Rodwin discreetly alluded to this in his 2015 paper when speculating as to “why prosecutors rarely use the strongest sanctions in their arsenal.” Rodwin hypothesized that it might be because they “prefer to seek monetary penalties to support their budgets.”
According to Violation Tracker, pharmaceutical penalties since 2000 have enriched federal (and state) coffers to the tune of over $87 billion.
Curiously, Public Citizen’s two reports showed a sudden drop in 2013 and 2014 in the number and size of settlements, with federal criminal penalties “nearly disappearing” by 2017.
Eager to counteract any perception of declining enforcement, a publication called FCA Insider proclaimed in early 2021 the DOJ’s “years-long effort … to be more proactive in combatting fraud,” optimistically suggesting that “sophisticated data mining tools” were going to help the nation’s top law enforcer achieve increased fraud-related recoveries.
An honest look at history shows, however, that far more often than not, the DOJ — and regulatory agencies like the U.S. Food and Drug Administration and Centers for Disease Control and Prevention — have been pharma’s biased partners in crime rather than its antagonists.
Examples of the phony and selective zeal for justice include the alleged fraud perpetrated by DOJ lawyers intent on denying compensation to thousands of National Vaccine Injury Compensation Program petitioners, and, more recently, Pfizer’s astonishing argument that a COVID-19-vaccine-related whistleblower lawsuit against it should be dismissed “because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker.”
And from the pharmaceutical industry’s perspective, handing over an $87-billion cut to the feds to grease the skids appears to be an acceptable price to pay.
As Public Citizen noted a few years ago, pharma penalties over the 1991-2017 period represented a paltry 5% of the 11 largest global drug companies’ net profits “during just 10 of those 27 years,” amounting to little more than a slap on the wrist.
Emphasizing the “stark imbalance” between penalties and profits, the consumer group concluded that without more sincere and active enforcement — including prosecution and jail sentences for executives overseeing systemic fraud — “illegal but profitable activities will continue to be part of [pharmaceutical] companies’ business model.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
By Roger Watson | TCW Defending Freedom | September 9, 2022
If you are not a daily recipient of the Global Health Now (GHN) newsletter, I strongly advise against starting. I do these things so you don’t have to. After all, I am not averse to a bit of ‘global health’ provided it is evidence-based, equitable, necessary and does not require me to start wiping my bottom with leaves.
The concept of global health now seems to be a platform for highlighting inequities we can do little about, guilt induction among the populations of Western countries and most recently conveying panic generated in Geneva at the WHO about relatively mild diseases to the rest of the world. In fact, global health is the superhighway along which the panic-laden WHO buses travel. No sooner has one bus gone (Covid-19) than another one (monkeypox) comes along.
It took them longer than I expected but they have got there now. Recent issues of GHN have been highlighting similarities between Covid-19 and monkeypox. Recently GHN reported how the ‘US monkeypox outbreak is marked by vaccine disparities’. Apparently ‘black people make up a third of US monkeypox cases but have received 10 per cent of vaccine doses’; this is being ascribed to ‘distrust of the medical establishment’.
That would be the medical establishment which recommended locking them down for nearly two years, wearing disgusting face masks which everyone knew did not work, and enforcing vaccine mandates and vaccine passports for a vaccine which was not necessary, did not work and is known to be potentially harmful. All power to the elbows of black Americans who have seen the light over the medical establishment ahead of the rest of the population.
Meanwhile, monkeypox has been ‘jostling’ the experts’ understanding of the disease. Once thought not to be transmitted asymptomatically, they now think that it can be. Bet you never saw that one coming. In further news, monkeypox patients are ‘exhibiting a plethora of symptoms not previously linked to the disease’ including ‘lesions in the throat or rectum’; but we have been here before in these pages.
A worrying symptom associated with monkeypox has been uncovered: it is ‘inflammation of the heart’, also referred to as myocarditis or heart muscle inflammation, which I am sure is receiving maximum attention and being played for all it is worth in an effort to get people lined up for jabs. It is worth noting that the above is based on a single case report and it ‘highlights the possibility of cardiac manifestations in patients with monkeypox infection’.
Contrast that with the known and widespread risk of myocarditis among young males following Covid-19 vaccines, the demonstrable increase in deaths among professional footballers (compulsorily vaccinated) on the field of play and the concomitant reaction described in the American Heart Association’s flagship journal Circulation as ‘rare and mild’.
Here is what that rare and mild condition can do to you: first ‘reduce the heart’s ability to pump blood. Myocarditis can cause chest pain, shortness of breath, and rapid or irregular heart rhythms (arrhythmias)’; then ‘if left untreated, myocarditis may lead to symptoms of heart failure, where your heart has trouble pumping blood the way it should. In rare cases, it leads to other problems, such as cardiomyopathy’. But not to worry, apparently ‘many people with myocarditis go on to recover completely’ but ‘the condition can also cause permanent damage to the heart muscle. This can lead to complications like arrhythmia and heart failure’. And it should only lay you low for six weeks; who wouldn’t want some of that?
If ever there was evidence for the social construction of diseases, we now have it in abundance. Just as with the ‘social construction of reality’ (Berger & Luckman if you can stand to read it) whereby nothing is real until it is experienced, and the reality depends on who is experiencing it, we have the same with these infections. The symptoms are clearly context-dependent and depending on what the context of the sufferer is, for example of myocarditis, they may or may not be taken seriously.
By Adam Dick | Ron Paul Institute | September 8, 2022
During the coronavirus scare, a small dissident group of American doctors stood up against the concerted effort of many politicians, people in the media, “public health” bureaucrats, doctors, and medical organizations to portray the coronavirus “vaccine” shots as “safe and effective” and something everyone should take.
Dissenting doctors also explained that, despite the scare campaign proclaiming otherwise, exposure to coronavirus created natural immunity, most people — especially younger and healthier people — faced minimal to nearly zero risk of death or serious sickness from coronavirus, and early treatments with common medicines and vitamins could prevent serious sickness.
Some doctors also wisely pointed out early on that actions such as mask wearing, business closures, and “social distancing” were ineffective in stopping the spread of coronavirus. A major warning from dissident doctors was that hospital protocols for dealing with coronavirus such as forced isolation of patients from friends and family, as well as routine use of ventilators early on and remdesivir later, created huge health risks of their own.
Pushers of the coronavirus scare denigrated all of these arguments of dissenting doctors as fringe and dangerous. But, as time has passed, more and more evidence supports these arguments. It is becoming increasingly understood among critical observers that it is the doctors derided as disinformation agents who turned out to be right all along.
These brave doctors stood up for people’s health and liberty by disputing the heavily pushed, and dangerous, coronavirus party line.
If only more people had heeded these doctors’ protestations, the harm from coronavirus and extreme actions taken in the in the name of countering coronavirus could have been significantly reduced.
Government, media, and big tech companies sought to silence these heroic doctors. In some cases, medical boards even sought to revoke their licenses — an action that puts a doctor out of business.
Now, in California, Governor Gavin Newsom has a bill — AB 2098 — on his desk that tells the state’s medical boards to punish doctors who challenge the coronavirus orthodoxy. AB 2098 directs the state medical boards to take action against such doctors in the state, including revoking these doctors’ license. That threat hanging over doctors would serve as a huge disincentive for even a small group of doctors to stand up for what they believe is true. It is a means of placing on doctors a medical propaganda straitjacket preventing them from using their unique expertise to advise people.
Suzanne Burdick provides a detailed examination of AB 2098 in a Wednesday Children’s Health Defense article you can read here.
FDA advisory member hints at ‘original antigenic sin’
By Maryanne Demasi, PhD | September 6, 2022
Following the recent authorisation of the new omicron boosters, the former US Surgeon General encouraged Americans to receive two to four mRNA jabs annually.
Residents in northeast Australia have been told they might need a fifth dose by the end of the year.
In fact, it wasn’t that long ago that New South Wales’ top doctor said that people should expect to receive covid-19 booster shots “indefinitely.”
But could repeated boosters at close intervals be causing more harm than good? I speak with experts concerned that policymakers are not following the science.
Earlier this year, the European drug regulator sent a dire warning to the world. The agency was concerned that repeated boosters every four months could weaken a person’s immune response to the coronavirus.
Marco Cavaleri, the agency’s head of vaccines strategy, said that regular boosters might be “overloading people’s immune systems and leading to fatigue.”
I spoke with Cody Meissner, an FDA advisory member, ahead of the agency’s April 6 meeting, during which experts were to discuss the evidence for a fourth dose. He told me that he was not convinced by the data at the time.
“I personally don’t think that we have sufficient basis on which to recommend a fourth dose, and we don’t know what the harm will be,” said Meissner.
“The reason we’re giving the vaccine is to keep people out of the intensive care unit and to keep people from dying, or even going into the hospital. So, before we vigorously endorse a fourth dose of this vaccine, I think we have to understand not only more about the immune response, but also about how much severe disease is occurring after three doses,” he added.
Meissner blamed socio-political interference for many of the questionable covid-19 strategies. “I think that the politicians and certain groups within society, such as the teacher’s union here in the United States, have driven a political agenda that is certainly not based on science. People like to say it’s based on science. It’s not. It’s based on emotion and generating great fear,” said Meissner.
Despite the concerns, most policymakers have forged ahead with recommending third, fourth and fifth doses for large swathes of the populations.
But over the past year, observational data have emerged from countries like the UK, Scotland and Australia showing that the most highly vaccinated people are acquiring the highest rates of covid-19 infections, suggesting that the vaccines have lost their effectiveness or something unexplained is happening.
Meissner hinted at a possible explanation for why someone’s immune response could be suppressed after multiple covid-19 shots. “It gets into this issue of ‘original antigenic sin’, which is still a theoretical issue, but may have some validity it seems to me,” said Meissner earlier this year.
Original antigenic sin – scientifically referred to as immune imprinting – is a phenomenon whereby prior exposure to one virus strain (e.g. wuhan stain) limits the development of immunity against new variants (omicron strain), because the immune system has been “imprinted” to favour the original strain.
This leaves the immune system trapped because the antibodies it prefers to produce against the original strain are ‘mismatched’ for the new strain.
Meissner said, “To keep vaccinating with very similar [wuhan] antigens, may or may not be beneficial — or the benefit may not outweigh the harm. I think we need to look at that.”
Since then, the data suggesting that immune imprinting is occurring, has only strengthened says Nikolai Petrovsky, Professor at Flinders University and developer of a protein-based covid-19 vaccine called SpikoGen® in use in Iran.
“I feel the evidence for immune imprinting is increasingly compelling. It’s a known phenomenon with flu where it was first described, and the data now suggests it’s happening with covid-19,” said Petrovsky.
“The omicron vaccines may struggle to switch the immune system of a heavily vaccinated person to making omicron-specific antibodies, as their immune system is so heavily biased toward the Wuhan spike protein in the original vaccines. In the end, this could be harder to achieve in a vaccinated person than someone who has not yet been exposed to any spike protein, for example, someone unvaccinated,” he added.
Petrovsky says not only do too many shots of the mRNA vaccines increase the risk of immune imprinting, but they also seem to be uniquely pushing the immune system into “tolerance” against the virus.
“Immune tolerance” occurs when the immune system becomes unresponsive to a particular antigen after repeated exposure. This is the principle for desensitising people to allergy, i.e. by repeatedly injecting them with small doses of the offending allergen over time.
Petrovsky points to a recent pre-print study out of Germany. “People who’ve had three or more doses of mRNA showed a change in their antibodies to IgG4 which is typically an antibody associated with allergy desensitisation but not a normal antibody seen produced after infectious disease vaccines,” said Petrovsky.
Petrovsky said, “What this means, we simply don’t know as this has never been seen before. That in itself is concerning as it indicates just how little we understand about what these new mRNA vaccines are doing and how they work. But to me, it raises a red flag that repeated doses of the mRNA vaccines might be driving immune tolerance against the virus. Maybe this could explain why the more doses of these vaccines, the less they seem to work, and more and more people are getting breakthrough infections?” Interestingly, the study did not find a similar shift in antibody patterns after AstraZeneca’s covid-19 vaccine.
Now, that the FDA has authorised the new bivalent boosters – which code for the original wuhan strain plus BA4/BA5 omicron lineages – without first requiring any human data to be collected, it has left many doubting that our public health authorities are even paying attention to the science.
OffGuardian | September 7, 2022
Yesterday, the UK’s Daily Mail published an article about a new app which claims to be able to diagnose Covid19 infection just through the sound of your voice.
The story was also covered by Sky, The Independent, the Telegraph and many others.
The Mail headlined:
Could a mobile APP replace lateral flows? Scientists reveal new Covid testing software that detects virus through a person’s voice in under a minute – and experts say it can be more accurate than a swab test
The article goes on to explain:
The Dutch researchers say coronavirus usually affects the upper respiratory tract and vocal chords, leading to changes in a person’s voice. The team decided to investigate whether it was possible to detect the novel virus in people’s voices.
This is not the first app to make this claim, as early in the “pandemic” as May 2020 an EU-funded group based in Cambridge began claiming they could diagnose “Covid” just by listening to people cough.
Now, does this make any sense? Is it really possible to diagnose disease just from the sound of someone’s voice?
Simply put, almost certainly not. Without seeing the scientists’ actual data it is not possible to rule it out completely, but there are multiple apparent issues.
So, even if “Covid19” was a thing (which it isn’t), and even if we try to be objective and open-minded about the idea, it doesn’t seem like it would be any use at all.
And honestly, it feels like we’re giving the concept WAY more respect than it deserves. The very idea you can diagnose disease through the sound of a voice is completely ridiculous. But Covid times have enabled all the clowns in the world.
However, if you want a little silver lining read the comments below the Daily Mail article, and see that no one is buying this. One of them makes an interesting observation:
So they have harvested your DNA with the PCR test swabs, now they are after your voice print as well?
Is that what’s really going on here? We can’t rule it out.
or go to
Aletho News Archives – Video-Images
By Dr Bouthaina Shaaban | February 23, 2017
A recently declassified CIA document prepared in 1983, and released on 20 January 2017, shows that the United States had at the time encouraged Saddam Hussein to attack Syria, which would have led to a vicious conflict between the two countries, thus draining their resources.
The report, which was then prepared by CIA officer Graham Fuller, indicates that the US tried adamantly to convince Saddam to attack Syria under any pretense available, in order to get the two most powerful countries in the Arab East to destroy each other, turning their attention away from the Arab-Israeli conflict. … continue
Aletho News If Americans Knew No Tricks Zone
Aletho News 