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The Meaning Of The Recent FDA Resignations

The Meaning Of The Recent FDA Resignations

Authored by Jeffrey Tucker via The Brownstone Institute,

How significant is it that the two top FDA officials responsible for vaccine research resigned last week and this week signed a letter in The

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The Meaning Of The Recent FDA Resignations

Authored by Jeffrey Tucker via The Brownstone Institute,

How significant is it that the two top FDA officials responsible for vaccine research resigned last week and this week signed a letter in The Lancet that strongly warns against vaccine boosters?

This is a remarkable sign that the project of government-managed virus mitigation is in the final stages before falling apart.

The booster has already been promoted by top lockdown advocates Neil Ferguson of Imperial College and Anthony Fauci of NIH, even in the face of rising public incredulity toward their “expert” advice. For these two FDA officials to go on record with grave doubts – and their perspective is certainly backed by the unimpressive booster experience in Israel – introduces a major break in the narrative that the experts in charge deserve our trust and deference. 

What’s at stake here? It’s about more than the boosters. It’s about the whole experience of taking away the control of health management from individuals and medical professionals and handing it over to modelers and government officials with coercive power. 

From the first week of March 2020, the US embarked on a wild experiment in virus mitigation, deploying a series of measures with a sweep and scope that had never previously been attempted, not in modern times and not even in ancient times. The litany of controls and tactics is long. Many of these measures survive in most parts of the US. The retail landscape is still filled with plexiglass. We are still invited to sanitize ourselves when going indoors. People still mask up in proximity to others. The “Karens” of the world are still actively shaming and denouncing anyone suspected of non-compliance. 

The vaccine push has been particularly divisive, with President Biden actively encouraging “anger” at those who don’t get the jab, even as he refuses to acknowledge the existence of infection-induced immunities. In several cities, people who refuse vaccines are being denied active participation in civic life, and a populist movement is rising up that scapegoats the refuseniks as the only reason that the virus continues to be a problem. 

All these measures were deployed in waves of controls. It all began with event cancellations and school closures. It continued with travel bans, most of which are still in place. Sanitization and plexiglass were next. Masks were rolled out and then mandated. The principle of forced human separation governed social interactions. Capacity limits indoors were a common feature. The US example inspired many governments around the world to adopt these NPIs (non-pharmaceutical interventions) and take away the liberties of the people. 

At each stage of control, there were new claims that we’ve finally found the answer, the key technique that would finally slow and stop the spread of SARS-CoV-2. Nothing worked, as the virus seemed to follow its own course regardless of all these measures. Indeed there was no observable difference anywhere in the world based on whether and to what extent any of these measures were deployed. 

Finally came the pharmaceutical interventions, voluntary at first but gradually mandatory, just as with each previous protocol began as a recommendation until it was mandated. 

At no point in these 19 months have we seen a clear admission of failure on the part of government officials. Indeed, it’s mostly been the opposite, as the agencies double down, claiming effectiveness while citing no data or studies, while social media companies backed it all by taking down contrarian posts and brazenly deleting accounts of people who dare cite dissenting science. 

The vaccine was the biggest gamble of all simply because the program was so expensive, so personal, and so wildly oversold. Even those of us who opposed every other mandate had hopes that the vaccines would finally end the public panic and provide governments a way to back out of all the other strategies that had failed. 

That did not happen. 

Most people believed that the vaccine would work like many others before them to block infection and spread. In this, people were merely believing what the head of the CDC said. “Our data from the C.D.C. today suggests that vaccinated people do not carry the virus, don’t get sick,” Rochelle Walinsky told Rachel Maddow. “And that it’s not just in the clinical trials, it’s also in real-world data.” 

“You’re not going to get COVID if you have these vaccinations,”President Biden said, reflecting what was the common view in the summer of 2021.

That of course turned out not to be the case. The vaccines appear to have been helpful in mitigating against some severe outcomes but it did not achieve victory over the virus. Israel’s surge in infections in August was among the fully vaccinated. The same happened in the UK and Scotland, and that precise result began to hit the US in September. Indeed, we all have vaccinated friends who caught the virus and were sick for days. Meanwhile, team natural immunity has received a huge boost from a large study in Israel that demonstrated that recovered Covid cases gain far more protection than is conferred by the vaccine.

The fallback position then became the booster. Surely this is the answer! Israel was first to mandate them. Here again, the problems began to show, as yet another magic bullet of disease mitigation failed. Then the inevitable headline came: Israel preparing for possible fourth COVID vaccine dose. So think about this because there is a sense in which the vaccines rank among the biggest failures: in a matter of a few short months, we’ve gone from the claim that they fully protect to they are pretty okay provided you get regularly scheduled boosters forever. 

Now to the striking resignation of two top officials at the FDA who were in charge of vaccine safety and administration. It was the Director and Deputy Director of the Office of Vaccines Research, Marion Gruber and Phillip Kause.

They gave no reason for their departure, which is scheduled for October and November. 

The case is fascinating because 1) people rarely resign cushy government jobs unless a higher-paying, higher-prestige job in the private sector awaits, or 2) they are being pushed out. It’s rare for anyone in a position like to to resign over a principled matter of science. When I first read that they were going, I figured something else was up. 

These days, extremely weird things are going on within the Biden administration. Even though his approval ratings are sinking, the president has to pretend that he has all the answers, that the science behind his mandates and virus war is universally settled, that anyone who disagrees with him is really just a political enemy. He has gone so far as to denounce, demonize, and legally threaten red-state governors who disagree with him. 

This is a deep problem for actual scientists working within the bureaucracy because they know for sure that all of this is a pretense and that the government cannot win this war on the virus. They simply cannot preside over more false promises, especially when the whole of their professional training is about assessing the safety and effectiveness of vaccines. 

So what can they do? In this case, it appears they had to get away before they dropped a bombshell. 

The bombshell is called “Considerations in boosting COVID-19 vaccine immune responses.” It appears in the prestigious British medical journal The Lancet. The two top officials are among the authors. The article recommends against the Covid booster shot that the Biden administration, following Fauci’s advice, is suggesting as the key to making the vaccines work better and finally fulfill their promise. 

Fauci and company are pushing boosters because they know what is coming. Essentially we are going the way of Israel: most everyone is vaccinated but the virus itself is not being controlled. More and more among those hospitalized and dying are vaccinated. This same trend is coming to the US. The boosters are a means by which government can save face, or so many believe.

The trouble now is that the top scientists at the FDA disagree. Further, they think that the push for boosters is courting problems. They think the current regime of one or two shots is working as well as one can expect. Nothing is gained on net from a booster, they say. There just isn’t enough evidence to take the risk of another booster, and another and another. 

The authors knew this article was appearing. They knew that signing it under the FDA affiliation would lead to a push for their resignations. Life would get very difficult for both of them. They got ahead of the messaging and resigned before it came out. Very smart. 

The signed article goes even further to warn of possible downsides. They point out that boosters might seem necessary because “variants expressing new antigens have evolved to the point at which immune responses to the original vaccine antigens no longer protect adequately against currently circulating viruses.” At the same time, there are possible side effects that could discredit all vaccines for a generation or more. “There could be risks,” they write, “if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines.”)

Bringing up such side effects is essentially a taboo topic. That this was written by two top FDA officials is nothing short of remarkable, especially because it comes at a time when the Biden administration is going all in on vaccine mandates. Meanwhile, studies are showing that for teenage boys, the vaccine poses a greater risk to them than Covid itself. “For boys 16-17 without medical comorbidities, the rate of CAE is currently 2.1 to 3.5 times higher than their 120-day COVID-19 hospitalization risk, and 1.5 to 2.5 times higher at times of high weekly COVID-19 hospitalization.”

From the beginning of these lockdowns – along with all the masks, restrictions, bogus health advice from plexiglass to sanitizer to universal vaccine mandates and so on – it was clear that there would someday be hell to pay. They wrecked rights and liberties, crashed economies, traumatized a whole generation of children and other students, ran roughshod over religious freedom, and for what? There is zero evidence that any of this has made any difference. We are surrounded by the carnage they created. 

The appearance of The Lancet article by two top FDA vaccine scientists is truly devastating and revealing because it undermines the last plausible tool to save the whole machinery of government disease management that has been deployed at such enormous social, cultural, and economic cost for 19 months. Not in our lifetimes has a policy failed so badly. The intellectual and political implications here are monumental. It means that the real Covid crisis – the task of assigning responsibility for all the collateral damage – has just begun. 

In 2006, during the early years of the birth of lockdown ideology, the great epidemiologist Donald Henderson warned that if any of these restrictive measures were deployed for a pandemic, the result would be a “loss of trust in government” and “a manageable epidemic could move toward catastrophe.” Catastrophe is exactly what has happened.

The current regime wants to point the finger toward the noncompliant. That is no longer believable. They cannot delay the inevitable for much longer: responsibility for this catastrophe belongs to those who embarked on this political experiment in the first place. 

Tyler Durden Thu, 09/16/2021 - 13:40

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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Walmart joins Costco in sharing key pricing news

The massive retailers have both shared information that some retailers keep very close to the vest.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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Walmart has really good news for shoppers (and Joe Biden)

The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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