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Fragmentation of World Economy Now Irreversible – Russia’s Representative at IMF

Sputnik – 25.06.2023

The use of international trade and the dollar as a weapon by the West makes the fragmentation of the world economy inevitable, Aleksei Mozhin, Executive Director for Russia at the International Monetary Fund (IMF), told Sputnik.

“The blatant use by the West as a weapon of international trade, finance, as well as the dollar and the euro itself, makes the fragmentation of the world economy not only inevitable, but also irreversible,” Mozhin said.

He pointed out that Western representatives at the IMF are trying to avoid this problem, and the leadership of the international organization cannot ignore the pressure that Western participants are exerting on it. As an example of the fragmentation of the world economy Mozhin mentioned the consequences of Western sanctions introduced against Russia.

“We have learned this lesson, we will never allow ourselves to be so dependent on imports again, at least in the strategic sectors of the economy,” Mozhin told Sputnik, adding that the whole world is now aware that globalization is forcing all countries to follow the path of specialization to the detriment of economic diversification and that the process of deglobalization will continue.

June 25, 2023 Posted by | Economics, Russophobia | , | Leave a comment

Zelensky Ratchets Up Culture War with Ban on Russian Books

By Kyle Anzalone | The Libertarian Institute | June 25, 2023

Ukrainian President Volodymyr Zelensky signed a bill last week banning the import of books produced in Russia or printed in the Russian language. The new law is Kiev’s latest escalation in its extensive effort to eliminate Russian culture in Ukraine.

Since taking office, Zelensky has led a campaign of “derussification” within Ukraine. Last year, Kiev’s legislature passed a bill that will heavily restrict books manufactured in  Russia or printed in the Russian language. Zelensky announced he signed the bill on Thursday, saying, “I believe the law is right.”

Kiev’s Culture Minister Oleksandr Tkachenko praised Zelensky for approving the ban. “The adoption of this draft law will protect the Ukrainian book publishing and distribution sector from the destructive influence of the ‘Russian world,’” he said.

The bill signed into law last week will ban all imports of books from Russia and Belarus. Additionally, the state will require a permit to import a Russian book from any third country. Zelenskiy’s office said the law would “strengthen the protection of the Ukrainian cultural and information space from anti-Ukrainian Russian propaganda.”

After Russia invaded Ukraine last year, Zelensky enacted a series of escalating steps with the goal of erasing, from Ukraine, any and all Russian culture. Kiev has worked to destroy all Russian monuments, rename public spaces that are in the Russian language, erase Russian historical figures, and target a branch of the Christian Orthodox church Kiev believes is too closely tied with Moscow.

Tkachenko has long been an advocate of the culture war in Ukraine. In a 2015 interview, he supported a ban on TV series and movies that are produced in Russia or glorify Russian people. One of Tkachenko’s goals at the time was to replace Russian content on Ukrainian televisions with Western programming.

While Kiev presents Moscow as the target of the culture war, the substantial minority of ethnic Russians and Russian speakers living in Ukraine are subjected to the laws. Zelensky has used the pretext of “derussification” process to consolidate control over Ukraine’s politics and media.

June 25, 2023 Posted by | Civil Liberties, Full Spectrum Dominance, Russophobia | , | 1 Comment

Clinical Trial to License RotaTeq, Like Almost All Childhood Vaccines, Did Not Use a Placebo Control

Those attacking RFK are wrong

BY AARON SIRI | INJECTING FREEDOM | JUNE 25, 2023

Robert F. Kennedy, Jr. is on record stating that almost all childhood vaccines were licensed based on clinical trials that did not include a placebo control. He is correct.

Nonetheless, numerous news outlets, such as Stat News in its article titled “Correcting Robert F. Kennedy Jr.’s vaccine ‘facts’”, are stating Mr. Kennedy is wrong because they claim the clinical trial relied upon to license the rotavirus vaccine, RotaTeq, did include a placebo control. They are wrong.

A placebo is defined by the CDC as a “substance or treatment that has no effect on living beings.” This means a saline injection or water drops in mouth.

RotaTeq is administered via oral drops. A “placebo” would have been water drops in the mouth. The control used in the trial, however, included bioactive ingredients including almost all the ingredients in the RotaTeq vaccine itself.

How do I know this? Because in 2018, on behalf of ICAN, we were investigating the control used in each clinical trial relied upon by the FDA to license each childhood vaccine.

In that review, we found that while the package insert for the RotaTeq vaccine says the control in its clinical trial was a “placebo,” when we read the FDA’s clinical trial review for RotaTeq, the ingredients of this so-called “placebo” were redacted:

So, on behalf of ICAN we submitted a Freedom of Information Act Request to the FDA for “Documents sufficient to identify the ingredients of the ‘placebo’ in the prelicensure clinical trials identified in Section 6.1 of the package insert for RotaTeq.”

In a response dated June 14, 2018, the FDA provided the requested documents which clearly show that the control was not a placebo. Rather, it included polysorbate-80, sodium citrate, sodium phosphate, and sucrose.

These same four ingredients are also contained in RotaTeq. The only difference between the vaccine and the control is that RotaTeq also included tissue culture medium and rotavirus reassortments. So, bottom line: the control used in the RotaTeq clinical trial was not a placebo since it included bioactive ingredients.

For example, here is what the NIH explains about sodium phosphate, one of the ingredients in the control:

Sodium Phosphate can cause serious kidney damage and possibly death. In some cases, this damage was permanent, and some people whose kidneys were damaged had to be treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well). Some people developed kidney damage within a few days after their treatment, and others developed kidney damage up to several months after their treatment.

And as these studies and data sheet make clear, polysorbate-80 is far from an inert substance, is bioactive, and can have safety concerns, especially when given to infants.

Bottom line, Robert F. Kennedy, Jr.’s claim that virtually all childhood vaccines were licensed based on clinical trials that did not include a control group that received a placebo is correct. The undisputable evidence for this claim, all from FDA or pharma sources, is detailed on pages 3 to 7 of a response we sent to HHS on December 31, 2018. (In sharp contrast to virtually all other childhood vaccines, the clinical trial relied on to license Pfizer’s Covid-19 vaccine for teenagers 12 to 17 years of age appears to have had a placebo control group, though we are still reviewing that claim.)

Here are copies of the charts from that 2018 response to HHS which show what the control group received in each clinical trial for each childhood vaccine:

It is also why the following claim by Dr. Paul Offit in his article “Should Scientists Debate the Undebatable” is categorically false: “All vaccines are tested in placebo-controlled trials before licensure.”

I would more than welcome a public debate with Dr. Offit on this point and would welcome being proven wrong – would gladly prefer that products injected into babies not have this safety gap. Oh, but wait, Dr. Offit says it is undebatable, which again shows precisely why there must always be complete, uncoerced choice when it comes to any medical product.

What is really incredible about the attacks on Mr. Kennedy is that he has made clear he has no intention of changing anyone’s right to obtain vaccines. Everyone who wants to keep vaccinating will be free to do so. He just wants to assure freedom of choice and help those who are injured by these products.

The media and medical profession’s attack on this position is callous. Just as they care about those injured by infectious disease, as Mr. Kennedy certainly does, they should also care about those injured by vaccines. Mr. Kennedy is clear that we can and should do both. And to his amazing credit, no amount of insult or attack has moved him from his position that we must protect every American, including those injured by these pharma products.

June 25, 2023 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | | Leave a comment

Was SARS-CoV-2 entirely novel or particularly deadly?

BY THOMAS VERDUYN, DR TODD KENYON, DR JONATHAN ENGLER | PANDA | JUNE 22, 2023

As part of our inquiry into the drivers of excess deaths, we take a step back and address the central theme of the Covid-era narrative: that SARS-CoV-2 is a novel virus that is so deadly that drastic measures were needed to contain it.

In the previous articles of this mini series about excess deaths we looked at how effective the Covid shots were at arresting Covid [1, 2] and also how bad the “first wave” in New York city was.[3] There are good reasons behind why we chose to address these two topics first. One reason is that an honest look at these issues helps establish a balanced understanding of what might be driving excess deaths since 2020. Another reason is that both topics were central to the official narrative emanating from government sources and the mainstream media. We were told that the whole point of the lockdowns was to delay the spread of SARS-CoV-2 until a vaccine could be developed that would spare us from overwhelmed hospitals like what happened in places like New York and Italy.

As has been shown, and to put it mildly, the Covid shots did not perform nearly as well as promised. Sadly, the burden of the adverse events caused by the experimental shots turned out to be worse than the disease.[4] Furthermore, by a close examination of excess deaths in New York city in early 2020, and in particular by a comparison to what happened on the Diamond Princess, it was concluded that the tragedy in New York was not compatible with the spread of a virus such as SARS-CoV-2, let alone any other generally mild respiratory virus.

All of this presses us to take a step back and address the central theme of the Covid-era narrative, namely the idea that SARS-CoV-2 is a novel virus that is particularly deadly; so deadly that drastic measures were needed to contain it. We begin with a look at the idea that the virus is novel.

1. How novel is SARS-CoV-2?

In the field of virology, the term “novel virus” typically means that the virus was recently discovered. This definition, of course, tells us nothing at all about when the virus first existed. Thus, for instance, the first human-coronavirus was found in 1961.[5] It was labeled B814 and identified as a cause of the common cold. This does not mean that this particular cold-causing coronavirus suddenly appeared in that year. No, and much to the rather, it only means someone finally found it. The ability to isolate, identify and sequence RNA viruses is a relatively new science. The patent on the process used in PCR machines was first granted in 1987.[6] It was in 2003, only 20 years ago, that the first human reference genome was sequenced. Despite all the efforts by many scientists, mankind has not yet sequenced every virus on planet earth. It is quite possible we never will. As a result, we are hardly in a position to assert when a particular virus (or strain of a virus) first appeared. Even if sequencing of a virus could prove beyond reasonable doubt that it was made in a laboratory, unless we had lab records to prove when it was made, it would still be nearly impossible to determine when it first infected someone. At best we might be able to estimate a timeframe by using antibody tests applied to stored specimens. The fact that SARS-CoV-2 is a relatively mild virus with symptoms similar to that caused by the flu only compounds the challenge. All we know for certain about this virus is that labs first began testing for it in early 2020.

The real problem with all of this is that during the Covid era the term “novel virus” was used by many outlets (including universities, journals, the media, and government officials) to mean something quite different from “recently discovered.”[7] For example, the GoodRx website has an article in which the authors say that “SARS-CoV-2, the virus that causes COVID-19, is a “novel coronavirus.” This means it’s different from all viruses like it.” They go on to say that “In medicine, novel refers to a virus or bacteria that wasn’t known to affect humans. This means that the bug is either brand new or was only found in animals or other life forms.” [8] Likewise, Dr. Tam, the chief medical officer of Canada, recently wrote, “In March 2020, Canada was faced with a… virulent pathogen… for which there was no natural immunity… and no effective antivirals.” So we see that the official narrative was not only that SARS-CoV-2 was recently discovered, but that it did not exist before late December 2019, was different from other viruses, was newly capable of infecting humans, was entirely new to our immune system, and was outside the scope of what doctors knew how to treat.

Are any of these claims true? Other than the fact that it was recently identified, the other claims are either false or dubious at best. It is useful to examine each claim on its own. We begin with a brief investigation into the possibility that SARS-CoV-2 existed before December 2019. Actually, there is growing evidence that SARS-CoV-2 was  around long before it suddenly acquired international attention. For instance, by searching through the public sequencing data archives, a group of researchers found that soil samples collected in Antarctica between Dec 2018 and Jan 2019 contained “sequence fragments matching the SARS-CoV-2 reference genome…” [9] This was so contrary to the official narrative that the authors later suggested that it had to be on account of laboratory contamination issues. But their findings were not unique. For example, by examining human blood samples taken in Italy before the Covid era, researchers found that already by September of 2019 some individuals (none of whom were sick at the time) had SARS-CoV-2 specific antibodies in their blood.[10 11] Other studies have found similarly.[12] Therefore, there is good evidence that the virus existed long before it garnered any attention.

Second, was SARS-CoV-2 that different from other viruses? The very fact that the virus was named “SARS-CoV-2” informs us that virologists think it is similar enough to SARS that it didn’t even warrant an entirely new name. Indeed, the two viruses are said to share “79.5% sequence identity.” [13] Despite the 20.5% difference, and notwithstanding the 17 year time lapse, studies have shown that people that were infected with SARS “possess long-lasting memory T cells… that displayed robust cross-reactivity to the N-protein of SARS-CoV-2.”[14]  Therefore, although possessing differences, it cannot be said that this virus is that different from other coronaviruses.

Third, was this virus newly capable of infecting humans? To answer this question, it may help to consider RaTG13, a bat coronavirus that is said to be the closest to our virus. The two viruses are reported to be 96% similar.[15]  Although it is commonly assumed that bat coronaviruses cannot infect humans without either a modification to its RNA or via an intermediate host, it is possible that bat coronaviruses jump to humans all the time, only without making us sick. For instance, a study done in 2018 found good evidence to conclude that bat coronaviruses are capable of infecting humans regularly, noting also that the “infections were subclinical or caused only mild symptoms.” [16] Conversely, experiments with blood samples of health care workers known to have had Covid demonstrated efficient neutralization of RaTG13.[15] Of particular significance in this regard is the little known fact that the PCR test for Covid, as designed by Drosten, was initially verified by making sure it detected coronaviruses from “bats in Europe and Asia.”[17] In other words, a positive PCR test may have indicated nothing more or less than the presence of a harmless bat coronavirus already endemic among humans. Although the Drosten test was later superseded by other tests, the official narrative emerged rapidly out of case detection using the Drosten test. Unfortunately, it is not clear to what extent this influenced early test results. In any case, it is certainly not novel that a virus of this sort could infect humans.

Fourth, is this virus entirely new to our immune system? Certainly not, for it was known from early on in the Covid-era that a significant percentage of people were immune to this supposedly novel virus. We previously observed that only 19% (712 of 3711) of the people on board the Diamond Princess cruise ship tested positive for the virus, and of these only a smaller fraction yet actually became ill.[4] Similarly, a group of researchers from Singapore “detected SARS-CoV-2 specific T cells in individuals with no history of SARS [or] Covid-19.” Remarkably, they also detected T cells in people that had no known contact with anyone that had had either SARS or Covid.[14] Likewise, a study in the UK found that many health care workers repeatedly tested negative despite repeated exposure to Covid.[18] The authors of that study concluded that “some individuals may clear subclinical infection before seroconversion.” Why did so many people never get Covid? Multiple researchers have concluded that it was likely a result of memory T-cells from a previous infection with a common cold or flu.[19, 20, 21, 22]

What percentage of people had sufficient  prior immunity to prevent illness? Those same researchers found it was about 50%. For instance, a study by Grifoni et al “detected SARS-CoV-2-reactive CD4+ T cells in ~ 40% – 60% of unexposed individuals, suggesting cross-reactive T cell recognition between circulating ‘common cold’ coronaviruses and SARS-CoV-2.” [23] In other words, about half the population was destined to never become noticeably ill from Covid for the simple reason that they recently had a cold. Nor is this particularly surprising since it was known that the original SARS virus had also cross-reacted with other coronaviruses.[24] Thus, the virus was not entirely novel to our immune system.

Fifth, was this virus new to doctors? As may be gathered from the fact that Covid was around long before March 2020, it is almost certain that before doctors were told that they were dealing with a novel virus that they supposedly did not know how to treat,  they must have unknowingly treated Covid as if it was any normal respiratory or influenza-like-illness. To the best of our knowledge, there is no record of doctors reporting an unusual increase in untreatable respiratory disease, at least not until the WHO officially declared Covid a pandemic. Even after doctors were advised it was an entirely new disease, treatment protocols were rapidly developed in multiple places.[25, 26, 27]

In summary, SARS-CoV-2 was “novel” only in the sense that it was first discovered in early 2020. It is certain that it existed globally for at least six months before this. Already by January 2020 about half the world’s population was immune to this virus. Nor was Covid outside the parameters of known treatments available for respiratory diseases. These facts should have been front and center in the media, and should have had a strong influence on government policies. Sadly, all this information was buried.

Of course, if Covid was not novel, it is impossible that it should have caused any excess deaths in 2020. It follows from this sobering conclusion that any and all excess deaths had to have been caused by other factors.

2. How deadly was Covid?

As was just pointed out, at least half of the population was essentially immune to Covid. For these people Covid was a non-issue. What about the other half? How lethal was it for them? Central to a proper answer of this question is the fact that our immune system is confronted with novel proteins all the time. Our survival does not depend on us having seen them or anything similar before. Rather, the immune system learns from all foreign material, remembers the experience, and serves to make future encounters less noteworthy. If at some point in the future a virus should arise that was both novel to our immune system and untreatable, even this would not necessarily mean that the virus was something to fear; certainly not to the extent of causing a cataclysm like we have recently witnessed.

In a previous article of this series [1] we made mention of a World Health Organization bulletin that estimated the Infection Fatality Rate (IFR) of Covid to be 0.23%.[28] That same bulletin also advised it might be substantially less than this. As data accumulated, the IFR was indeed found to be lower, eventually converging on a global average of about 0.15%.[29] For people under 70 years old, the average IFR of Covid drops down to 0.07%.[30] Of course these estimates were determined using information from death certificates and PCR test results, which (as shall be explained below) may have introduced significant inflationary errors into the results. The IFR of Covid may therefore be much less than 0.15%.

Moreover, it is well established that severe Covid illness is generally linked to those with underlying medical conditions, meaning it is rare in  healthy individuals. For instance, a study looking at more than half a million people hospitalized in the USA with Covid found that 94.9% “had at least 1 underlying medical condition.” [31]

Nevertheless, for the sake of argument let us accept these estimates at face value and proceed to ask how Covid compares with the flu? The IFR of influenza is generally considered to be about 0.1%, and in a typical season about 8% of Americans get sick from the flu.[32] As for Covid, despite the unprecedented numbers of people that were tested for this virus, the total number of Covid cases in the USA during 2020 totaled 19.2 million,[33] or about 5.7% of the population. Thus, by all metrics it would appear that Covid in 2020 was on par with or less than a normal flu season.

The fact that Covid is not a particularly lethal disease was known since early 2020. For instance, the UK government officially declared that “as of 19 March 2020, Covid-19 is no longer considered to be an HCID in the UK.” [34] The acronym HCID stands for “high consequence infectious diseases.” Therefore, for the vast majority of people, the wonderful and immensely complicated human immune system was more than adequate to fight off a Covid infection.

If in fact Covid was only as bad as a normal flu season, why did it garner so much attention? And why have government dashboards suggested that Covid is causing millions of excess deaths in the world? The answer to the first of these two questions will have to be postponed for a future article. As for the second question, it is helpful to look a little closer at excess deaths in 2020. A recent study by Levitt et al analyzed all-cause mortality rates in 33 countries from 2009 to 2021. They found that during this 13 year window, the year 2020 was the worst year with the highest mortality for only four countries: “UK, Italy, Spain and Belgium.” [35] Another 10 countries had “the highest mortality in 2021.” (USA and Poland were the worst). As for the remaining 19 countries, either 2009 or 2010 had the highest mortality.

Was there anything particularly special about 2009 that made it the worst year for more than half these countries? Actually, it was found to be the worst for two simple reasons: mortality rates have in general been decreasing over time, and 2009 is as far back as the study went. Of interest is that in 2009 the WHO declared a pandemic on account of the H1N1 virus. Nothing special came of it, however, for “the total number of influenza-related deaths worldwide… proved similar to the number in a relatively mild year of seasonal influenza.” [36]

The fact that 2020 was the worst year for only 4 of these 33 countries lends support to our conclusion that Covid was about as bad as a normal flu season. The fact that 2021 was the worst year for 10 countries helps reinforce our previous findings that the Covid shots did very little to prevent Covid deaths and instead caused a great deal of deaths from adverse events.

3. Covid Data Issues

How is it possible that a mortality analysis seems to contradict reports about millions of Covid cases and deaths? There are several good reasons for this apparent discrepancy. For starters, and as was mentioned in a previous article,[1] on April 20, 2020 the WHO mandated changes to the way death certificates were to be filled out. The document stated that “a death due to Covid-19 is defined for surveillance purposes as a death resulting from a clinically compatible illness.” [37] In other words, since influenza typically has identical symptoms to Covid, flu deaths were to be labeled as Covid deaths. While this may be useful for “surveillance purposes,” it does not help us determine if Covid caused any excess deaths. Nor is it useful for making accurate comparisons between Covid and the flu. And it most definitely makes it difficult to calculate the IFR of Covid.

The WHO document went on to say: “A death due to Covid-19 may not be attributed to another disease (e.g. cancer)… Always apply these instructions whether they can be considered medically correct or not.” Therefore, even if cancer was the actual cause of death, if the person so much as tested positive for Covid, the death certificate was to say that Covid was the cause of death. The end result of this change in policy is that the number of deaths caused by Covid has been significantly over-counted in most countries.[38, 39, 40, 41] What was not affected by the protocol change was how many people died from all causes. This is why all-cause mortality studies are so relevant during the Covid-era.

Another issue muddying the waters is the PCR test used to identify a Covid case. Despite the fact that the PCR test is based on remarkable technology, it has various shortcomings when used as it was to establish a Covid case. Very briefly, a few such issues are:

  • If the cycle threshold is too high, it will return a high number of false positives.[42]
  • As disease prevalence decreases, the risk of false positives increases.[43, 44]
  • The number and type of primers used for identifying the presence of SARS-CoV-2 has the potential to pick up fragments originating from some other source.[45, 46] (As we saw above, harmless bat coronaviruses may give a false positive.)
  • The PCR test is capable of finding virus fragments,or intact virus in the airway, but is not capable of determining if a person is actually infected with Covid. Since clinical symptoms were not required to be present, many uninfected individuals falsely tested positive. [47, 48]

Every issue listed above has the tendency to inflate Covid deaths.

4. Covid in Canada

To put things into perspective, and to tie all these ideas together, it is appropriate to consider one particular country in more detail as an example. Let us consider Canada. Statistics Canada records that 16,151 deaths in 2020 were attributed to Covid.[49] This is slightly more than twice the number of deaths attributed to “Influenza and Pneumonia” in an average year in Canada (7304 deaths/yr). How is it possible that Covid was more than twice as deadly as the flu if the two illnesses are about the same?

The answer is either that the number of Covid deaths was overcounted due to all the issues just mentioned or that influenza deaths were underdiagnosed in the past. Unfortunately, it is now nearly impossible to determine the exact error rate. Nevertheless, by considering only the last of the issues in the above list, it is possible to demonstrate how significant the inflation factor really is.

Dr. Bullard, head of the provincial laboratory in Winnipeg Manitoba, testified that PCR tests do not verify infection and were never intended to be used to diagnose respiratory illness.[50] He went on to say that about 56% of positives in Canada belonged to  people that were not infected with Covid. If we accept this percentage, in all likelihood at least 56% of the deaths attributed to Covid in Canada were a result of a false positive. Applying this error rate to Covid deaths in Canada in 2020 brings the number of deaths down to 7,106. It is duly noted that this number is slightly lower than the yearly average for influenza deaths in the preceding four years. If we use this adjusted amount, and plot mortality in Canada in 2020 by the top 15 leading causes of death, we can see the relative significance of Covid in Canada.

Figure 1. Source: Statistics Canada. Table 13-10-0392-01

Covid mortality was adjusted down by 56% to account for false positives.

In Figure 1 above, cancer and heart issues dwarf all other causes of death. The number of deaths attributed to flu and pneumonia is several thousand below average. This resulted from the fact that, according to the WHO mandate, many deaths that would normally have been classified as influenza were labeled as Covid because the two are clinically compatible illnesses. Also, Canadian labs changed the way they tested for the flu: “changes in laboratory testing practices as a result of the public health response to… Covid-19… may affect the comparability of data to previous… seasons.” [51] What is clear from this chart is that Covid was not particularly lethal, was no worse than a normal flu season, and certainly unworthy of the unprecedented attention it received.

Conclusion

In conclusion, it is safe to say that SARS-CoV-2 was “novel” in early 2020 solely because of the simple fact that that is when it was first detected. Not only was Covid treatable, but at least 50% of people had sufficient immunity from a previous common cold to prevent noticeable illness. It can also be said that Covid was not unusually lethal, since the mortality burden was only as bad as a normal flu season. Covid mortality (when adjusted for only one of several factors) ranked ninth among the leading causes of death in Canada, the same rank normally held by influenza and pneumonia.

Of course, it could be argued that the reason Covid deaths were this low is because government mandated lockdowns and other non-pharmaceutical interventions prevented a Covid catastrophe. It is this important topic that we plan to cover in our next article of this series.

References

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June 25, 2023 Posted by | Science and Pseudo-Science, Timeless or most popular | , | Leave a comment

FDA Approves 2 New Diabetes Drugs for Kids — Critic Says Clinical Trial Sample Was ‘Shockingly Low’

By Suzanne Burdick, Ph.D. | The Defender | June 23, 2023

The U.S. Food and Drug Administration (FDA) this week approved two drugs to treat Type 2 diabetes for children ages 10 and up, “as additions to diet and exercise,” the agency said.

The drugs — Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) — previously were approved for adults with Type 2 diabetes to improve blood sugar control.

They join metformin, approved in 2000 to treat Type 2 diabetes in children.

“Compared to adults, children with Type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., MPH, associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

But critics like pediatrician Dr. Elizabeth Mumper said the agency’s action ignores the root causes of Type 2 diabetes in children while generating profits for pharmaceutical companies:

“Rather than doing the hard work of preventing chronic diseases by cleaning up multiple environmental sources of harm to children, we allow the pharmaceutical industry to spend millions to develop drugs that do not address root causes of conditions like diabetes but do create lifelong medicine customers.”

Mumper, the former medical director of the Autism Research Institute, said “a pill for every ill” is “not a good strategy for pediatric care.”

Type 2 diabetes used to be called “adult-onset diabetes” — but now we are seeing it in younger and younger ages, Mumper told The Defender. In her state of Virginia, 31% of children are overweight or obese, she said.

“This is a clear risk factor for insulin resistance progressing to Type 2 diabetes,” Mumper said, adding:

“We are redefining normal by assuming Type 2 diabetes is a reasonable condition in children to treat with medicine instead of attacking the root causes of this ever-increasing chronic condition.

“We continue to allow Big Food to sell food-like products which are devoid of nutritional value and filled with sugar and bad fats that are addicting and proinflammatory.”

‘System is rigged for Big Food and Big Pharma, with kids … as the losers’

Nina Teicholz, author, science journalist and founder of The Nutrition Coalition — a “non-profit, non-partisan educational organization that aims to improve health in America by ensuring that the public receives evidence-based nutritional advice” — also emphasized the importance of diet in successfully preventing and managing Type 2 diabetes.

Commenting on the FDA’s new drug approval, she said, “This is another Pharma victory, promoting drugs while ignoring diet,” adding:

“The system is rigged for Big Food and Big Pharma, with kids, getting fatter and sicker, as the losers.”

We’ve known for more than a decade that people can safely reverse their Type 2 diabetes through diet alone — “within a matter of just weeks,” Teicholz said. “But multiple government agencies ignore this lifesaving science while the FDA approves drugs instead.”

Adult participants in a 2017 peer-reviewed study who used a ketogenic diet to manage their blood sugar levels reported a 1.0% reduction in their hemoglobin A1c — while reducing their medications — and were still sustaining that reduction one year later, Teicholz said.

In contrast, the FDA safety and efficacy trial of empagliflozin — the active ingredient in the two newly approved products — showed the drug reduced the recipients’ hemoglobin A1c by 0.2% in 26 weeks.

According to the authors of a study released Thursday:

“Type 2 diabetes, which makes up the bulk of diabetes cases, is largely preventable and, in some cases, potentially reversible if identified and managed early in the disease course. However, all evidence indicates that diabetes prevalence is increasing worldwide, primarily due to a rise in obesity caused by multiple factors.”

The study, published in The Lancet, projected the number of adults with Type 2 diabetes will more than double — to 1.3 billion — by 2050.

‘Shockingly low’ clinical trial sample size makes it impossible to assess adverse events

Commenting on the FDA’s safety and efficacy trial for the drugs, Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense, told The Defender :

“The sample size for this clinical trial is shockingly low. Given that 157 patients were split into three separate treatment groups, it was impossible to properly assess adverse events from the drug.

“I would expect that the trial be at least 10 times larger with a longer period of follow-up than 26 weeks, given that these children would be on the drug indefinitely.”

According to the product’s website, Jardiance can have serious side effects, including increased ketones in blood or urine — which may be accompanied by nausea, vomiting, abdominal pain, tiredness and breathing difficulty, allergic reactions, dehydration, serious urinary tract infections, yeast infections, low blood sugar and necrotizing fasciitis.

Necrotizing fasciitis is “a rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum),” the company said.

Synjardy listed the same possible side effects, plus a possible deficiency in vitamin B12 caused by using metformin for long periods of time.

The drugs are manufactured by insulin producer Eli Lilly and its partner Boehringer Ingelheim.

Eli Lilly’s revenue for the quarter ending March 31 was $6.960 billion.

The pharmaceutical industry in 2022 funded about 75% of the FDA’s drug division, The New York Times reported.

Meanwhile, the FDA said that based on the results of a “SEARCH for Diabetes in Youth” study involving more than 27,000 youth, the incidence of Type 2 diabetes in children increased by 4.8% per year from 2002 to 2015 and is expected to continue increasing.

The agency did not comment on why researchers believe the rate of Type 2 diabetes in kids is expected to rise but noted:

“As of 2017, there were approximately 28,000 cases of Type 2 diabetes in children in the U.S.

“By 2060, if current trends continue, that number is predicted to be approximately 220,000, with the majority of cases occurring in minority racial and ethnic groups such as Non-Hispanic Blacks and Hispanics.”

Additionally, the FDA last year approved the first drug designed to delay the onset of Type 1 diabetes for children as young as 8 years old.

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. She has taught at various academic institutions in the United States and is fluent in Spanish.

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.

June 25, 2023 Posted by | Corruption | , | Leave a comment

The climate scaremongers: What is a normal climate anyway?

By Paul Homewood | TCW Defending Freedom | June 23, 2023

We are told we must limit global warming to 1.5 deg C. The target became official when the 2015 Paris Agreement on climate was signed. Its overarching goal was to hold ‘the increase in the global average temperature to well below 2°C above pre-industrial levels’ and pursue efforts ‘to limit the temperature increase to 1.5C above pre-industrial levels’.

Why 1.5C? The previous threshold of 2C was a far too distant one, and few people would have been worried about something which might not happen for several decades, so the UN decided they needed to come up with something much more imminent. Hence their claim that ‘crossing the 1.5C threshold risks unleashing far more severe climate change impacts, including more frequent and severe droughts, heatwaves and rainfall’. A recent study even claims that global warming above 1C is already causing significant harm to humans.

What does this mythical figure of 1.5C really mean? As noted above, it is measured from pre-industrial levels, even though we have no clue what global temperatures were then. Indeed, we don’t know what they are now, despite scientists trying to convince us by coming up with global temperatures to hundredths of a degree.

We are said to have already reached about 1.2C of warming, which to be fair broadly corresponds with the long-running Central England Temperature series. But why choose pre-industrial times at all? What evidence is there that there was anything ‘normal’ about the climate 200 years ago?

The reason is very simple. 1.5C sounds a lot, and the whole objective is to scare the public. The reality is that everybody is used to today’s climate, and it is from this that any increases should be measured. But nobody would be scared by a threat of warming of a tenth of a degree or so in 30 years’ time.

The implication is that the climate was normal and unchanging before we started burning fossil fuels. But that period was known as the Little Ice Age (LIA) for a very good reason. We know from multiple sources that the LIA was probably the coldest period since the last Ice Age ended. Evidence from ice cores in Greenland, glacial records in Europe, Greenland, Iceland and Alaska, upper tree line studies in the Alps and North America and other data overwhelmingly supports this conclusion.

Even New Zealand did not escape the clutches of the LIA. Eminent historian Brian Fagan wrote in his seminal book, The Little Ice Age, that the Franz Joseph glacier there was ‘a mere pocket of ice on a frozen snowfield nine centuries ago . . . Then Little Ice Age cooling began and the glacier thrust downslope into the valley below, smashing into the great rain forests that flourished there, felling giant trees like matchsticks. By the early 18th century, Franz Joseph’s face was within 3 km of the Pacific Ocean . . . The high tide of glacial advance at Franz Joseph came between the late 17th century and early 19th century, just as it did in the European Alps’.

Fagan also described how the advance of glaciers in Switzerland obliterated thousands of acres of farming land, and what remained was far too cold to grow anything. As a result famine was rife.

It was not just glaciers that were the problem. A couple of years ago, a Portuguese scientist wrote a synthesis of the LIA in Europe in general and Portugal in particular. He tells a story of heavy rainfall and floods, heatwaves, droughts, cold wet summers, snow storms, famines and malaria.

It is clearly nonsensical and dishonest to claim that the climate was somehow ‘normal’ in pre-industrial times. And it is certainly deranged for anybody to suggest that the world’s climate is now worse.

The year in review – perfectly ordinary

THE Global Warming Policy Foundation has just published my annual review of the UK’s weather. Once again, I find little to be alarmed about.

Although 2022 was a comparatively warm year, the long-term mean temperature has been largely unchanged since the turn of the century. Rainfall and storm trends are, respectively, unexceptional and favourable.

Here is the report’s executive summary:

According to the Met Office, the UK climate ‘is continuing to change’, while weather is becoming more extreme.

But what does the actual evidence tell us?

Using official data up to 2021, from the Met Office and other sources, this paper examines UK climate trends, and assesses the truth of these claims.

The results are as follows:

•    Although 2022 was the warmest on record in the UK, there has been no increase in long-term averages since the early 2000s.

•    The annual temperature in 2022 was well within the bounds of natural variability, and was largely due to long spells of sunny weather in spring and summer.

•    The summer of 2022 was only the fourth hottest according to CET, and not as hot as 1976, 1826 and 2018.

•    Annual rainfall last year was only slightly below average.

•    The number of days with extreme temperatures is not increasing, as fewer cold days are offsetting more hot ones.

•    Long-term averages in rainfall in England and Wales, which have been rising since the 1970s, are similar to the 1870s and 1920s.

•    While winters have become slightly wetter, there is little change in the other seasons. In particular, summers are not getting drier, as projections have suggested.

•    Rainfall is not becoming more extreme, whether on an annual, monthly or daily basis.

•    Sea levels have been rising at around 1.7mm a year around the UK, after taking account of vertical land movement, and there has been no acceleration in the rate of rise on multi-decadal scales.

•    Wind storms have been declining in frequency and intensity since the 1990s.

In short, although it is slightly warmer than it used to be, the UK climate has changed very lit­tle. Long-term trends are dwarfed by the natural variability of weather.

Nor is there any evidence that weather is becoming more extreme. Nothing in the data indicates that climate will become more extreme in future.

The full report can be downloaded here.

June 25, 2023 Posted by | Aletho News | 2 Comments

Trump’s 2024 lead widens after latest indictment

RT | June 25, 2023

Donald Trump’s lead over his nearest Republican opponent for the party’s 2024 presidential nomination has nearly doubled since the former US president was indicted on federal charges earlier this month, a new poll has shown.

The NBC News survey, released on Sunday, shows that Trump is the first choice for 51% of Republican primary voters, compared with 22% for Florida Governor Ron DeSantis and 7% for former vice president Mike Pence. Trump’s 29-point lead over DeSantis compares with a 15-point margin when the same poll was done in April.

Pollsters began the latest survey on June 16, a week after the ex-president was charged with 37 felonies by a US Department of Justice (DOJ) special prosecutor over his alleged mishandling of classified documents. Trump has tried to turn the case to his political advantage, just as he did after a New York City prosecutor charged him in April for allegedly falsifying business records.

“Every time the radical-left Democrats, Marxists, communists and fascists indict me, I consider it a great badge of courage,” Trump told supporters on Saturday at a Christian voter conference in Washington. “I’m being indicted for you, and I believe the ‘you’ is more than 200 million people that love our country.”

A Harvard CAPS-Harris poll released earlier this month showed that Trump leads incumbent President Joe Biden by a margin of 45% to 39% in a hypothetical 2024 rematch of their 2020 race. An Emerson College poll released on Thursday found that a third-party candidate, such as philosopher and activist Cornel West, would draw support away from Biden, giving Trump an advantage.

Results of the NBC News survey suggest that the federal indictment has made Trump even more politically polarizing. While 21% of respondents said they have a “very positive” view of him, up from 17% in April, 49% gave a “very negative” assessment, up from 44% previously.

Just 20% of US voters believe the nation is on the “right track” under Biden, down from 23% in January. At the same point in Trump’s presidency, the number was 33%. Just 18% of voters have a “very positive” view of Biden, down from 29% in the early days of his presidency, the poll showed.

The current and former vice presidents, Kamala Harris and Mike Pence, have even lower favorability ratings. Only 11% of voters have a “very positive” view of Harris, while Pence’s rate is even worse, at 3%. DeSantis went from a 19% “very positive” rate in September 2022 to 14% this month.

Voters also give low marks to the DOJ, with 14% rating the department very positively, down from 18% in the most recent reading before Trump’s indictment.

June 25, 2023 Posted by | Civil Liberties, Corruption | | Leave a comment

WWF declared ‘undesirable’ in Russia

RT | June 21, 2023

Russia’s Prosecutor-General on Wednesday declared the World Wide Fund for Nature (WWF), also known as the World Wildlife Fund, “undesirable.” Moscow accused the Switzerland-based nonprofit of working on behalf of the US against Russia’s economic and security interests, especially in the Arctic.

The Prosecutor-General’s Office said that the WWF used environmental and educational activities “as a cover for implementing projects that pose security threats in the economic sphere.”

Specifically, “under the pretext of preserving the environment, the WWF is carrying out activities aimed at preventing the implementation of [Russia’s] policies for the industrial development and exploration of natural resources in the Arctic territories, while developing and legitimizing restrictions that could serve as a basis for transferring the Northern Sea Route into the exclusive economic zone of the US.”

The NGO is especially targeting large enterprises engaged in the energy sector, the oil and gas industry, and also the mining of mineral deposits and precious metals, according to Russian officials. The Prosecutor-General’s Office in particular objected to the WWF’s use of the ESG (Environmental/Social/Governance) scores to rate Russian companies, which are based solely on the “subjective standards and criteria developed by the WWF.”

The WWF has provided material and other support for several Russian NGOs that have been included in the registry of foreign agents, such as ‘Friends of the Baltic’ and the ‘Sakhalin Environmental Watch’. The Russian Ministry of Justice declared the WWF itself a foreign agent in March this year.

Being declared undesirable is an effective ban on the organization. It must shut down its offices in Russia, and doing business with it is punishable with a fine or jail in case of repeat offenders. The first organization to be designated so was the US Congress-funded National Endowment for Democracy (NED), in 2015.

Another environmentalist NGO, Greenpeace, was declared unwelcome last month after allegations it had sought destabilization and change of government in Russia “through unconstitutional means.”

June 25, 2023 Posted by | Malthusian Ideology, Phony Scarcity | | 1 Comment

The US can’t stop the rise of Iran, but it can make a truce

By Timur Fomenko | RT | June 25, 2023

In 2018, the Donald Trump administration ripped up the Joint Comprehensive Plan of Action (JCPOA), known as the “Iran nuclear deal,” which had been signed by his predecessor Barack Obama.

The decision to scrap the deal was thoroughly influenced by neoconservative members of his cabinet, including National Security Advisor John Bolton and Secretary of State Mike Pompeo, who not only saw the opportunity to take a swipe at Trump’s predecessor, but argued that placing crippling unilateral sanctions on Tehran would bring the country to the negotiating table, and if not, bring the regime down altogether.

Thus began a five-year campaign of brutal pressure against Iran, which sought to destroy its economy and attempted to coerce third-party countries away from doing business with it. But the initiative didn’t go according to plan. Rather, the world changed. The flagrant disregard of international law by Washington was a catalyst in the emergence of de-dollarization. The global shake-ups that came next, including the Covid-19 pandemic, US competition with China, and the war in Ukraine, gave Tehran strategic space and leverage it had previously lacked.

Now, Iran has substantially increased its uranium enrichment, has continued to build its drone and missile capabilities, has an enhanced military relationship with Russia, and thanks to Beijing, has been able to normalize its relationship with its regional arch-rival Saudi Arabia. In the process of doing so, it has reduced the regional influence of the US and its partner, Israel. US foreign policy on Iran has revolved around exploiting regional tensions in order to justify its own security footprint, but Iran has seemingly been able to begin to supersede a campaign of US containment against it while not being overtly belligerent.

This has set alarm bells off in Washington. The US has been desperate to try and reinforce its relationship with Saudi Arabia, but has reportedly been engaging in secret negotiations with Tehran not to revive the JCPOA, but to keep it away from further uranium enrichment and off the nuclear path, a move which of course will have to come with sanctions relief. While the US, presumably with the support of Israel, has threatened unspecified military action if Tehran goes further, it seems clear that Iran now has all of the cards and that a temporary “truce” must therefore come at the expense of the US containment campaign.

Because of the regional dynamic shifting in its favor, Tehran is highly unlikely to actually go down the path to developing a full-fledged nuclear bomb, given the opportunities it would provide to Washington. Unlike a country like North Korea, Iran doesn’t truly need nukes in order to establish a doctrine of deterrence for its own regime’s survival. It is a large country with a population of over 80 million. While the United States could hypothetically conduct air or missile strikes on key Iranian facilities to try and impede its nuclear program, what the US could not do, especially in this environment, is a full-scale invasion and occupation of the country. It would cost trillions of dollars, and there would be no support for it.

Rather, Iran’s deterrence ability is premised on its drone and missile programs, which have grown in their capabilities over the years despite US sanctions. The country recently claimed to have developed hypersonic missiles, which while some skepticism is warranted, is not completely fictional. Tehran has, after all, in response to the assassination of Revolutionary Guards Corps commander Qasem Soleimani, shown its ability to destroy US military bases within its range, and therefore demonstrate what it could do to Israel if things turned nasty. In doing so, it is demonstrating that regardless of US sanctions, it is a significant regional player, and will continue to be.

US foreign policy towards adversaries has repeatedly attempted to seek maximum strategic gain, eschewing the idea of compromise, be it China or Russia. But when it comes to Iran, Washington is stumped on what to do without taking the risk of provoking a wider conflict. This is why the Biden administration is leaning towards giving in, knowing that the regional dynamic of the Middle East is shifting away from its favor, and taking punitive action which may provoke war is unwelcome. In other words, Iran is winning. The only question which remains is whether or not the US wants a truce or to keep pressuring Tehran until it snaps? Even if the outcome ends in a sheer stalemate, with no nuclear lines crossed, it’s still a lose-lose situation for Washington in the end as Iran re-establishes itself diplomatically.

June 25, 2023 Posted by | Militarism, Wars for Israel | , , , | 1 Comment

NEW CDC DIRECTOR: LEADER OR FOLLOWER?

The Highwire with Del Bigtree | June 23, 2023

President Joe Biden’s new pick for CDC director, Dr. Mandy Cohen, has an interesting track record as lead health director of North Carolina’s pandemic response. Find out the scientific methods she used to create policy and guidance during the COVID-19 pandemic.

June 25, 2023 Posted by | Civil Liberties, Science and Pseudo-Science, Timeless or most popular, Video | , , , , , | 1 Comment