Posted originally on the CTH on February 16, 2023 | Sundance
When Ohio Senator JD Vance was briefing the press earlier today, he was asked about East Palestine residents being required to sign indemnity waivers, releasing Norfolk Southern Railway from legal liability, as a requirement of having their water/air tests conducted on their property.
Senator Vance said he talked to a resident about it, then reviewed the contract and confirmed the indemnity demand. Vance then immediately called Norfolk Southern Railroad officials and asked them about it. According to Vance, the response from Norfolk Southern Railway was that the liability waiver was accidentally presented. WATCH (@24:54 Prompted):
.
Does anyone really believe the contingency waivers were “accidentally” presented to the residents?
War is never a ONE-SIDED affair. People get frustrated and will often seek revenge personally on both sides of any conflict. These people who point to Russians as killing civilians and vice versa should understand one thing. EVERY war results in MORE civilian casualties than military. I do not know what planet these people are on, but cheering war is one great way to reduce the population.
Just check the stats on World War II. The total estimated deaths were 70–85 million people. That was about 3% of the estimated 2.3 billion global population in 1940.
Total Death … 70-85 million (50-56 million directly & 19-28 million from starvation/disease)
Military deaths ….. 21-25 million
Civilian Deaths….. 50-55 million
Anyone claiming the Russians killing civilians is somehow a war crime should check history. It is typically civilian deaths are double that of the military. So while Zelensky and the Western powers refuse to end this war and just let the Donbas separate as was set out at the Minsk Agreement, should understand the civilian death toll in Ukraine may easily be 50% or even hire all for land that was never Ukrainian in the first place. The West is using the Ukrainian people as fools for they are simply there to weaken Russia so NATO can invade Moscow in the end. The Ukrainian people are simply cannon fodder and the sooner they wake up and realize that are just a pawn being sacrificed in this proxy war against Russia the sooner they can reclaim their life.
I get the typical hate mail because I do not blindly accept Ukraine is fighting against the Russian evil empire for democracy or freedom related to its own people. One clearly Neonazis sent an email:
“There will definitely be a very special place in hell for you and the sooner you get there the better.”
I have encountered the Neonazis of Ukraine. They would slaughter every Russian in the Donbas. I do not tolerate fools, politicians, or people who are consumed by their own hate that they cannot see clearly or even think rationally. Their hatred is consuming the world and they will do whatever they can to completely destroy every Russian no different than the German Nazis who sought to exterminate every Jew.
I have been in the middle of this entire Russian affair since 1999. Both sides have always hurled arrows at me. So I am just used to it. When Galina Starovoytova (1946-1998), who was the head of the Democratic movement in Moscow, was assassinated, suddenly the old hardlines were targeting me and said she was a puppet of a Western financier, which was supposed to be me. I was shocked that I was suddenly being targeted I believe by the head of the old guard Primakov who I believe had been behind her assassination and the attack on me. The only connection was that her son was working in our London office at the time.
I always get the arrows from every side. That is just part of life.
Democrats in Rhode Island have prepared legislation that could double taxes for parents of unvaccinated children. Senator Sam Bell, who is championing the bill, claims that there is a need for a universal mandate. Under the proposed law, unvaccinated residents would face a $50 monthly fine for noncompliance. Employers would also be required to mandate vaccines for all employees or face a $5,000 fine per violation. The biggest burden – “Any person who violates this chapter shall be required to pay a monthly civil penalty of fifty dollars ($50.00) and shall oweTWICE THE AMOUNT OF PERSONAL INCOME TAXES.”
To receive an exemption for a minor, three separate doctors must confirm that the child is “not fit for immunization.” Then the state would need to investigate each claim and determine whether or not the parents should be financially ruined. So even if three different doctors say that a child should not be vaccinated, the state may override them.
Biden lost his bid to implement a federal vaccine for employers last year, but the battle is not over. State lawmakers still have the capabilities to force compliance through any means possible. Bell wants to make the state of Rhode Island unlivable for the unvaccinated. While this is unlikely to pass, the fact that they are still attempting to force vaccinations in April 2022 shows that the war on medical freedom has not ceased.
A March 16 opinion piece in The BMJ raises some serious questions about what they call, “The illusion of evidence based medicine.” Authors Jon Jureidini and Leemon B. McHenry posit that the prominence of evidence-based medicine constituted a paradigm shift, meant to give a solid foundation in science for our medical care system. But the validity of the paradigm depends of accurate data from clinical trials, and most of these are conducted by the pharma industry and then published under the name of “senior academics.” Public release of what had been confidential pharma industry documents gives the medical world key insights into the level to which pharma-sponsored trials are mischaracterized. Getting a bit philosophical, The BMJ argues that critical rationalism is key for both the integrity of science and the role of science, “in an open, democratic society.” But this ideal is under threat by corporate power, a world in which, “financial interests trump the common good.” The dominance of massive pharma firms involves some competition, but all these players are united in working to expand the general pharma market. And while what the authors call, “free market champions” have embraced privatization, “the unintended, long-term consequences for medicine have been severe.”
Medical Schools Take Neo-Liberal Approach
Knowledge and data ownership hamper progress in science due to the fact that the pharma industry tends to suppress negative trial outcomes, not report adverse events, and not share their raw data with the research community. To quote The BMJ, “Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.” And duty to shareholders’ “hierarchical power structures” prioritizes both product loyalty and public relations over integrity. Further, while our fancier universities face influence from their endowments, “they have long laid claim to being guardians of truth and the moral conscience of society.” And facing reduced government funding, these schools have taken the, “neo-liberal market approach,” seeking out pharma funding, with strings attached.
Doctors as “Product Champions”
And thus, science departments at a broad swath of our universities can be seen as “instruments of industry.” When you combine firm-level control of the research agenda and the “ghosting writing of medical journal articles and continuing medical education,” scholars can transform into promotors of commercial products. Further, media reports of “industry-academe partnerships[s]” add to a general mistrust of our academic institutions that betrays the very vision of an open society. And what The BMJ calls the “corporate university” itself undermines the idea of academic leadership. Where once deans were folks with “distinguished contributions to their disciplines,” now they are more of fundraisers/academic managers who must show their “profitability” and ability to attract corporate sponsorship. And medical academia’s stars, who tend to be opinion leaders, advance their careers via industry opportunities. These folks are hired based largely on their influence on the “prescribing habits” of other doctors. The opinion leaders are also often well-paid by pharmaceutical advisory boards and speakers’ bureaus in the context of presenting results of pharma industry trials. And instead of being “independent, disinterested scientists,” they can become “product champions,” in the parlance of marketing executives.
Reforms Called For
Proposals for reform can include, “liberation of regulators from drug company funding; taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymized individual patient level trial data posted, along with study protocols, on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results.” For readers seeking more information, the American Medical Association’s Code of Medical Ethics Opinion 7.1.4 sets out that organization’s policies on conflicts of interest in industry-funded research.
A March 16 opinion piece in The BMJ raises some serious questions about what they call, “The illusion of evidence based medicine.” Authors Jon Jureidini and Leemon B. McHenry posit that the prominence of evidence-based medicine constituted a paradigm shift, meant to give a solid foundation in science for our medical care system. But the validity of the paradigm depends of accurate data from clinical trials, and most of these are conducted by the pharma industry and then published under the name of “senior academics.” Public release of what had been confidential pharma industry documents gives the medical world key insights into the level to which pharma-sponsored trials are mischaracterized. Getting a bit philosophical, The BMJ argues that critical rationalism is key for both the integrity of science and the role of science, “in an open, democratic society.” But this ideal is under threat by corporate power, a world in which, “financial interests trump the common good.” The dominance of massive pharma firms involves some competition, but all these players are united in working to expand the general pharma market. And while what the authors call, “free market champions” have embraced privatization, “the unintended, long-term consequences for medicine have been severe.”
TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.
Marik, board certified in Internal Medicine, Critical Care Medicine, Neurocritical Care, and Nutrition Science, is a key opinion leader who has worked in numerous hospitals and health systems from South Africa, UK, and of course, the United States where he is most recently affiliated with Eastern Virginia Medical School (EVMS) as well as other medical institutions. Not a stranger to controversy, or for that matter, pushing the comfort boundaries of the medical establishment, Marik isn’t a lightweight, with over 400 peer-reviewed journal articles, 50 book chapters, and author credits for four critical care books.
Recently, he filed a lawsuit against his hospital over the institution’s ban on various therapies including ivermectin, which happens to be a core therapy in his and his colleagues MATH+ Hospital Treatment Protocol for COVID-19. He and colleagues such as Dr. Pierre Kory experienced what they declare is censorship, as key journals had reviewed and accepted manuscripts, such as with the Journal of Intensive Care Medicine, only to see the approvals retracted. Physicians such as those affiliated with the FLCCC represent prominent figures at this weekend’s medical freedom march.
The alternative media reporter, Heather Mullins, shared that New Hampshire’s bill is now “sponsored” and must still “go through some hurdles to get passed,” but if done so will “essentially make ivermectin available over the counter.” According to the TrialSite report, the proposed bill would authorize access at the pharmacy via a “standing order” which generally indicates authorization for nurses, pharmacists, and other appropriately credentialed health care professionals that if directed by state law, empowers the direct care and admonition of a vaccine or therapy (in this case ivermectin) based on an approved medical doctor-based approved protocol.
TrialSite didn’t report that Paul Marik testified for the proposed bill in New Hampshire. Mullins reports that Marik and other front-line physicians have been on the record that if ivermectin had been allowed for use as an early at-home prophylactic treatment targeting COVID-19, hundreds of thousands of lives could have been saved.
The Interview
Prior to the testimony in New Hampshire, Dr. Marik shared that 3.7 billion doses of ivermectin have been administered around the world, “changing the face of parasitic diseases on this planet.” Marik declared that ivermectin “is probably the second most important drug ever invented” [the drug’s inventors did win a Nobel Prize and the drug is on the World Health Organization Essential Drug List].
Declaring that the drug is cheap, safe, and “highly effective against SARS-CoV-2, and if used more widely this drug could have saved hundreds of thousands of lives.”
Referring to its use in many other countries, the critical care physician went on the record that it’s a “lifesaving drug.”
Why the pushback against ivermectin? Marik, now somewhat liberated given he isn’t dependent on his employer Sentara, let loose declaring, “There are multiple reasons, and this is probably generated by Big Pharma, government, and big corporations who don’t like cheap repurposed drugs.” He continued, “So this is a war on cheap, repurposed drugs.” Emphasizing the goals of ivermectin’s adversaries, Marik stated, “They want you to use expensive designer drugs which in fact don’t work.”
In clarifying his understanding of the New Hampshire bill, Marik declared it is proposing to make ivermectin available over the counter [again via standing order] and according to the critical care doctor, it makes sense given the drug’s safety profile— “the drug is safer than Tylenol,” stated Marik. Repeating again the drug’s safety profile makes it safer than Tylenol, he went on the record “People should be given access to this drug in order to prevent and treat COVID.”
Marik espoused the critical FLCCC view that early treatment for COVID-19 absolutely represents a critical care strategy: simply waiting at home for a symptomatic phase, prompting a trip to the hospital raises significant danger for severe disease and worse.
The Controversy
According to Heather Mullins’ report, there has been a coordinated effort to censor the robust data pointing to at least some ivermectin-based efficacy around the world. Ivermectin study watchers often point to the website which tracks all ivermectin studies in a clean, orderly series of tables and graphs. While the majority of the 75 completed studies point to positive data points, the mainstream media and medical establishments in North America, Europe, and Australia have limited the number of studies within the research portfolio that they even acknowledge to just a handful. The others? These studies are dismissed because of bad quality.
A couple of prominent studies showed no benefit, yet, at least one of them became surrounded with controversy and allegations among some industry watchers of conflict of interest. TrialSite notes this hasn’t been proven, and one study in Egypt that was part of a couple of meta-analysis studies turned out to have manipulated data. Yet even with the questionable Egyptian study, TrialSite’s Sonia Elijah’s investigation raised some disturbing questions in “How Ivermectin became a Target for the Fraud Detectives.”
TrialSite has chronicled ivermectin studies all over the world, including the ICON study done in Broward County early on during the pandemic. Of course, this study wasn’t a randomized controlled trial, thus limiting its impact. Interviews with the head of the largest hospital in the Dominican Republic as well as a well-respected investigator in Dhaka, Bangladesh, and interactions with doctors in Nigeria, Zimbabwe, South Africa, and India found positive data points. TrialSite even sponsored an objective documentary in Peru, one of the first nations to accept the use of the drug for the novel coronavirus.
After numerous interviews, study write-ups, and real-world observations, the case for ivermectin should be taken seriously. The U.S. National Institute of Health is financing an ivermectin-based study called ACTIV-6, while the University of Minnesota led one of the largest ongoing ivermectin studies called COVID-OUT.
The drug does have a proven safety profile at doses currently approved for parasitic indications. However, claims that higher dosages are just as safe as Tylenol might be a stretch—rather that claim would be associated with currently approved indications. Yet, it’s not a stretch to declare the drug is generally safe if taken off-label under the guidance of a licensed, competent physician.
The FDA’s behavior during this pandemic in association with ivermectin has been questionable, to say the least. Issuing warnings to the public not to use the animal variety of the drug, they emphasized that for the human version, it should be used only in clinical trials. TrialSite’s Sonia Elijah’s piece on obtaining FDA emails suggested the possibility of some form of disinformation campaign emanating from the world’s most respected food and drug regulatory body—an activity, if true, is beneath this organization.
FDA letters to medical and pharmacy boards and medical societies have led to considerable pressure on doctors employed by health systems and pharmacies not to allow ivermectin prescriptions off-label for COVID-19. In addition to a survey substantiating this trend, TrialSite chronicles plenty of instances evidencing efforts to block access. The TrialSite survey evidenced the effectiveness of an ongoing purge.
While there has been much controversy following the drug, Marik, Kory, and others actually visited the National Institutes of Health COVID-19 Treatment Guidelines Panel to discuss the evidence of efficacy against SARS-Cov-2 in early 2021.
from use only in clinical trials to the following recommendation:
There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
Yet if the drug is generally safe and a licensed physician along with an appropriately consenting patient agree to an off-label regimen, why would this vary from other standard off-label use cases that no one makes a fuss about? What is it about COVID? TrialSite has observed based on the severity and intensity of the pandemic, more federal involvement, and intervention in healthcare. Concerns of ivermectin took off when government, industry, and regulators discovered that prescriptions skyrocketed from 3,000 per week pre-pandemic to nearly 90,000 per week during the second year of the pandemic.
TrialSite recently reported on a study led by a University of Michigan doctor showing that at least $130 million in insurance claims for the drug treating COVID-19 in 2021—that figure is probably more than double when counting all the cash-based prescriptions.
Call to Action: What are your thoughts? Is the federal government simply trying to protect people by blocking access to ivermectin or is this part of some regulatory capture movement? Does this mean industry’s interest supersedes patients? Perhaps, the truth is more nuanced. While this TrialSite fact check on the fact checkers (Ivermectin) could be updated, its core arguments are sound.
TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.
The lockdown in Shanghai has caused immeasurable damage to the people and battered an already stunted global supply chain. The wealthy are now fleeing the city, as numerous agencies have reported a large uptick in immigration requests. The Financial Times reported a 7-fold increase in the search term “immigration” among residents.
The media has downplayed this story as they do not want the people to remember governments’ capabilities. As with the fall of many great cities, the wealthy are the first to leave. Shanghai may be one of the richest cities in China, but it is not immune to government tyranny.
Only 25 deaths in Shanghai were attributed to the coronavirus, but over 25 million people directly suffered from this lockdown. The lockdown was not about safety. Warehouses are beginning to open, but the world’s largest port ceased operations. Again, no world leaders commented heavily on these major issues.
Pets of the “infected” were eliminated by the government. There were reports of people jumping from high rises and others begging the police to take them to jail with the hope of having a meal. No world leaders have commented on these human rights abuses as they were done in the name of COVID.
Posted originally on the conservative tree house on April 21, 2022 | Sundance
Someone might want to knock Anthony Fauci down a few pegs from his high-horse position. In this brief video, Fauci was asked for his opinion on the recent federal court ruling that the CDC exceeded its authority with a federal transportation mask mandate.
According to Fauci, the CDC bureaucratic science should supersede any constitutional, legal or limiting positions by the legislative or judicial branches of government. In essence he’s saying the CDC is above the law. WATCH:
The CDC is a subservient regulatory agency just like every other agency within government and is just as subject to the laws and legal limitations of the constitution as any other agency would be. However, in the worldview of Fauci and the Branch Covidians, the power of science puts them above the law.
In semi-related news…. “Philadelphia will end its COVID-19 indoor mask mandate less than a week after reinstating it, city health officials said Thursday night.” {LINK}
TrialSite chronicled the efforts of Dr. Jackie Stone in Zimbabwe during the worst stages of the pandemic. Born in Zimbabwe, Dr. Stone has been fascinated by research since a young age, and her commitment to caring for people during the pandemic has been legendary. While her off-label ivermectin-based combination regimen was identified with the saving of many lives in this southern African country, the medical establishment isn’t too keen on thinking outside of the box, even during the worst pandemic in a century. Dr. Stone now faces a court trial with criminal charges for merely treating COVID-19 patients with an early outpatient treatment protocol based on a combination of off-label treatments that includes ivermectin. This, even though Dr. Stone treated many in the Zimbabwe government and military successfully. In fact, for a while, the Medicines Control Authority of Zimbabwe (MCAZ) authorized access on an emergency basis for research—which amounted to care in this low-and middle-income country. The regulatory agency did a turnaround with ivermectin due to the results in the clinic of Dr. Jackie Stone.
Articles about Dr. Stone and Zimbabwe can be found at TrialSite. A fighter to the end originally of English and Norwegian descent, curious, and tough, yet elegant and empathetic, she grew up in the bush in this part of Africa, as her father was involved with geology and mining. Dr. Stone’s ethos, integrity, and commitment to doing good should have led her to awards from groups such as the World Health Organization.
Together Trial Mainstream Media Interpretations Could Put Low-Cost Regimen at Risk in MICs
Stone recently got together remotely with TrialSite’s founder Daniel O’Connor to discuss her concern with the Together Trial. While mainstream media have pounced on the findings, at least a dozen physicians and scientists are findings various issues with the data.
Ed Mills, the principal investigator, did the right thing investing his time as well as raising money to study repurposed drugs. While the Together trial’s primary endpoint failed to show efficacy for ivermectin, even Mills went on the record in a private email declaring ivermectin proponents should be upbeat about some of the data generated in the study. But Mills’ data was taken by mainstream media and used as a weapon to attack the use of the drug worldwide. This isn’t Dr. Mills’ fault–again he took the time to investigate the drug as well as other important repurposed drugs.
But Stone’s concern centers on the needs of low and middle-income countries (LMICs) for low-cost, available regimens for early care. Stone told TrialSite, “in poor and up-and-coming countries we don’t always have the luxury of waiting around for gold standard evidence. Rather, in the case of the pandemic, we need to move fast, and we did, leading to the saving of many thousands of lives.”
She continued, “My concern now is that papers such as the New York Times or Wall Street Journal pounce on data, often misinterpreting quotes from the PI can lead to a cutting off of life-saving approaches in LMICs such as my country.”
“Dr. Stone’s commitment to LMICs cannot be denied based on a clear track record of success. With COVID-19 came politics around the use of off-label drugs such as ivermectin, and unfortunately, Dr. Stone is caught in the middle of a political battle, but she is one of the most resilient individuals I have ever come across,” reports TrialSite’s O’Connor.
What about Together?
Dozens of scientists and doctors now pour through data of the Together Trial. Recently, Dr. David Wiseman, affiliated with TrialSite, shared a dozen bullet points of concern associated with Together, including inputs from Dr. Flavio Cadegiani and others that TrialSite poses as questions.
Together Trial Questions: Ivermectin
#
Question/Concern Issues for Discussion with Together Trial
1.
Did the ivermectin arm of Together run later than the placebo arm, a time when a more virulent strain was present in that part of Brazil?
2.
Why wouldn’t the protocol call for screening for ivermectin use—after all the drug was used in many parts of Brazil. Were those participating already using the drug? It would be hard to prove now.
3.
The critics fret about the lack of reported boosts in gastrointestinal side effects in the ivermectin arm leading to what they believe is a fundamental problem with the study—either A) placebo group was on ivermectin or B) those taking ivermectin were not administered real study drug
4.
Were these placebo pills produced to look identical to the study drug? As the drug is commonly used, this would have unblinded the study.
5.
Together used ivermectin alone yet the early care community uses the drug in combination with other economical safe drugs such as antibiotics, steroids, as well as nutraceuticals such as vitamin D, C, and zinc. The study of ivermectin alone doesn’t mean much to frontline doctors.
6.
Together started up to 8 days post symptom onset, but frontline ivermectin proponents declare the drug should be given immediately upon symptomatic infection. The P.1 variant also saw a faster progression to severe illness only compounding the problem.
7.
In the Together study, they used a dose of (0.4 mg per kilo per day) which many critics called inadequate for ill patents–was the study underdosed?
8.
Given ivermectin proponents suggest using the drug till symptoms are resolved, why did the Together protocol only call for use for 3 days?
9.
Why did the protocol call for administration of the drug on an empty stomach when proponents declare the drug works best when associated with consumption of fatty food?
10.
Why is so much basic data missing from the study results such as Recruitment Period, Recruitment Locations, Recruitment and allocation order per sit, Description of how the molecules and placebo were produced or compounded to look identical (otherwise loss of blinding); why is there missing age data for 98 patients? Other gaps in data or anomalies are present for those interested
11.
Some basic math shows that the numbers listed in the trial paper for the different arms and outcomes in the trial do not add up to the totals and percentages that they give – either a gross mathematical error or fraud. To see many of the strange mathematical discrepancies which invalidate the trial conclusions, go to investigative journalist Phil Harper’s article: Moreover Wiseman declares And the alteration of the death count in the trial data raises serious questions:
Seeking more information about Dr. Stone?
For all of those interested in Dr. Stone’s story check out the many articles published in TrialSite along with this important letter authored by Dr. Eleftherios Gkioulekas, Professor of Mathematics Undergraduate Program Coordinator at The University of Texas — Rio Grande Valley School of Mathematical and Statistical Sciences in Edinburg, Texas.
Call to Action: TrialSite suggests a fund to support Dr. Stone in her legal battle if needed.
Recently scientists from Denmark led an important study suggesting that mRNA-based vaccines such as the ones made by Pfizer or Moderna may not be as safe as adenovirus-based vaccines such as Johnson and Johnson, AstraZeneca/Oxford or the one produced by China’s CanSino Biologics. Led by Peter Aaby, a trained physician and anthropologist that runs a health and demographic surveillance system site in West Africa as part of the Bandim Health Project and Dr. Mihai Netea a well-known award winning Romanian/Dutch scientists and Danish colleagues from Odense Patient Data Explorative Network (OPEN) at University of Southern Denmark, the group scrutinized possible “non-specific effects” (NSEs) of the COVID-19 vaccines probing into overall mortality such as not only COVID-19 deaths but also accidental deaths, cardiovascular deaths and other non-COVID-19 deaths. The team discovered that out of 74,193 participants in mRNA clinical trials and 61 deaths, that based on relative risk there was no real difference between the vaccine and placebo group. While in the adenovirus-based studies with 122,164 participants and 46 deaths the vaccine had nearly half the level of deaths as compared to the controls group.
The study team decided to take a step back and look at the COVID-19 vaccine clinical trial data from a different point of view. They did this because “there is now ample evidence that vaccines can have broad heterologous effects on the immune system.” Such effects can either A) greater protection or B) increased susceptibility to unrelated infections or even other non-infectious autoimmune diseases. The authors report that emerging study data reveals that “vaccines may have completely unexpected effects on overall mortality, different from what could be anticipated based on the protection against the vaccine-targeted disease.”
The study results await peer review thus the data shouldn’t be considered evidence. But the novel approach and consequent findings represent an important potential contribution to our scientific knowledge of the COVID-19 vaccines.
Overall Mortality wasn’t Studied
Taking a different perspective, Dr. Aaby and team share that the current batch of COVID-19 vaccines were not tested to evaluate their effects on overall mortality. That would have been difficult given the short follow-up in the studies as subjects participating in the control groups received the vaccine after 3-6 months based on the emergency use authorization situation.
Surprisingly, although all would assume that the COVID-19 vaccines would reduce overall mortality in the pandemic this assumption hasn’t been formally vetted in studies.
The authors utilized the final study reports available from the COVID-19 vaccine trials investigating the impact of mRNA and adenovirus-vector COVID-19 vaccines on overall mortality, including the previously mentioned other categories such as cardiovascular-related deaths.
The Findings
The table below highlights these study findings:
Participants
Deaths
Relative Risk
mRNA
74,193
61 (mRNA 31; placebo; 30)
1.03 (95% CI=0.63-1.71)
Adenovirus
122,164
46 (vaccine: 16; controls:30)
0.37 (0.19-0.70)
Aaby and team report that the adenovirus-vector vaccines were associated with protection against COVID-19 deaths (RR=0.11 (0.02-0.87)) and non-accident, non-COVID-19 deaths (RR=0.38 (0.17-0.88)).
Of note, mRNA-based vaccines differ markedly from adenovirus vaccines regarding impact on overall mortality (p=0.030) as well as non-accident, non-COVID-19 deaths (p=0.046). The placebo-controlled RCTs of COVID-19 vaccines were halted rapidly due to clear effects on COVID-19 infections. Importantly the data derived from this study suggest an important need for randomized controlled trials of mRNA and adeno-vectored vaccines head-to-head comparing long-term effects on overall mortality.
Brief Discussion
Of course, many experts may summarily dismiss such findings as not relevant. After all the COVID-19 studies were designed to determine if the vaccines were effective in protecting against death from SARS-CoV-2, the virus behind COVID-19. Yet the authors point out that “non-specific effects, and their immunological basis, have been established for several other vaccines.” For example, the authors point to randomized controlled trials showing that BCG vaccine against tuberculosis (TB) lessens neonatal mortality, yet this was because the vaccine protects against deaths from sepsis and respiratory infections.
They point out that “immunological studies have shown that such effects are indeed biologically plausible; BCG positively affects the innate immune system leading to enhanced resistance towards a broad range of pathogens. Furthermore, the BCG vaccine has been associated with decreased systemic inflammation.”
Conclusion
The authors conclude that if their findings are in fact validated by randomized controlled studies then the adenovirus-based vaccines may prove beneficial to their “protective heterologous effects…on non-COVID-19 mortality” as well as their effectiveness against SARS-CoV-2 infection. Could these vaccines represent an advantage in vulnerable populations susceptible to cardiovascular mortality. Key is a better understanding of the heterologous effects between the different vaccine types.
Study Funding
Dr. Allen Schapira funded the work on non-specific effects of vaccines while some of the previous work was funded by the Danish Council for Development Research, Ministry of Foreign Affairs, Denmark; Novo Nordisk Foundation and European Union.
Lead Research/Investigator
Peter Aaby, DMSc, Bandim Health Project, INDEPTH Network; Bandim Health Institute – OPEN, Institute of Clinical Research
Christine Stabell Benn, University of Southern Denmark – Odense Patient Data Explorative Network (OPEN); Bandim Health Project, INDEPTH Network
Sebastian Nielsen, University of Southern Denmark – Odense Patient Data Explorative Network (OPEN)
Mihai G. Netea, Radboud University Nijmegen – Radboud Center for Infectious Diseases (RCI); Radboud University Nijmegen – Department of Internal Medicine
This is a library of News Events not reported by the Main Stream Media documenting & connecting the dots on How the Obama Marxist Liberal agenda is destroying America
Centinel2012 