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MEDICINE AND HEALTH

The FDA’s See-No-Data Approach A study showed promise in treating a rare disease. The agency wouldn’t even look at the results. By Stephen Cederbaum and Emil Kakkis

https://www.wsj.com/articles/fda-food-and-drug-admin-arg1-d-pegzilarginase-aeglea-biotherapeutics-arginine-deficiency-healthcare-c9e8c21f?mod=opinion_lead_pos6

We’ve spent most of our medical careers investigating and treating rare genetic conditions, including some afflicting only a few dozen Americans. Recently, scientists developed a treatment for one such condition—arginase 1 deficiency, or ARG1-D, which causes the amino acid arginine to accumulate in the blood, harming the brain and causing seizures, stunted growth and intellectual disability. The Food and Drug Administration has refused to consider the therapy. Its decision ignores the best available data and indicates a lack of understanding of rare-disease research.

Discovering treatments for rare diseases is a daunting task. Recruiting even a few dozen people for a clinical trial requires doctors and drug companies to identify a large share of the patient population. And since the market for such therapies is necessarily small, it’s nearly impossible to attract investment. So when news emerged aboutAeglea BioTherapeutics’ ARG1-D therapy pegzilarginase, we could hardly believe it. Pegzilarginase is an enzyme engineered to lower the body’s levels of arginine. The randomized placebo-controlled study of pegzilarginase included 32 patients with ARG1-D.

The results speak for themselves. The amount of arginine present in blood plasma declined by 80% for patients on pegzilarginase. After only six months, 90.5% of patients who received pegzilarginase had normal arginine levels, and this was sustained over time. The data also suggested progressive improvements in motor function compared with a placebo. And most patients tolerated the therapy quite well.

These numbers were jaw-dropping. Which is why the FDA’s decision is incomprehensible.

Reports From the Front Lines of the Vaccine Catastrophe – Part 3 Troubling reports describing the plight of patients, doctors and hospitals over the last 9 months. Docs and nurses are “waking up.” Oncologists are seeing tons of “turbo” cancers. It’s real.

PIERRE KORY, MD, MPA-https://pierrekorymedicalmusings.com/p/reports-from-the-front-lines-of-the-ef4?utm_source=substack&utm_campaign=post_embed&utm_medium=email

The point of these “Reports From the Front Lines” posts is to bring to life all of the accumulating data of the mRNA vaccine’s toxicity and lethality. I am trying to relate what it is like for those professionals who are “awake” and “on the ground.” I believe the below will well manifest the lived experiences and observations of appropriately trained and concerned citizens during this historic pharmageddon.

In the below, I will share numerous “anecdotes” compiled from my ever-expanding network of contacts, colleagues, confidants, patients etc. I have no reason to believe any of these observations or reports are anything but reflective of their reality/truth. I understand that an anecdote is an anecdote. But a 100 anecdotes.. is a 100 anecdotes. And so on and so forth. You know what you can do with your pharma-conducted randomized controlled trials.

A large number of these observations come from “My Spy On The Inside” who I will call “MSOTI” below. Recall that she is a veteran ER-ICU nurse in a major academic health center. She knows pretty much everyone there; hospitalists, specialists, sub-specialists, nurse managers, blood bank technicians, department directors, IT experts, hospital administration, you name it.

She was very early to catch on to the toxicity and lethality and corruption around the vaccines and has been documenting what she is seeing. In the first 2 posts (here and here) and in what follows is, with her permission and some identifying details removed, a lot of what she has related to me in our text and telephone conversations over the past 18 months.

If the first two posts were not frightening enough, these next ones are a doozy (this is Post 3 and I have three more coming). I transcribed (and lightly edited the medical acronyms) from numerous text conversations that me and MSOTI have had over these last months, but I also included reports from others in my network.

I will start off with the below post from a commenter on my recent Substack which described the plight of the vaccine injured in our current medical system:

CDC Confessions Did the government quash discussion about the ineffectiveness – and danger – of vaccines? by Lloyd Billingsley

https://www.frontpagemag.com/cdc-confessions/

With mysterious new variants allegedly emerging, Joe Biden announces new vaccines “for everybody,” regardless of what they had done in the past. As this news breaks, former Centers for Disease Control director Dr. Robert Redfield reveals that the government health bureaucracy tried to quash discussion about the ineffectiveness of Covid vaccines.

“There was such an attempt to not let anybody get any hint that maybe vaccines weren’t foolproof, which, of course, we now know they have significant limitations,” said the former CDC director, co-founder of the University of Maryland’s Institute of Human Virology and Chief of Infectious Diseases at the University of Maryland School of Medicine.

“My position was just tell the American public the truth. There are side effects to vaccines. Tell them the truth and don’t try to package it.” In similar style, “I think we should really have confidence and not be afraid to debate the issues that we think are in the public’s interest and just tell the public the truth,” said Redfield (pictured above), who had been at odds with the government health establishment before.

In 2021, Redfield told CNN, “I’m of the point of view that I still think the most likely etiology of this pathology in Wuhan was from a laboratory, you know, escaped.” After these statements, as Vanity Fair reported, “death threats flooded his inbox,” some from prominent scientists.

“I was threatened and ostracized because I proposed another hypothesis,” Redfield explained. “I expected it from politicians. I didn’t expect it from science.” The people might expect the FBI, on full alert against “domestic violent extremists,” to investigate death threats against a public official. If any investigation took place, nothing has been reported.

In May of 2021, Joe Biden tasked the intelligence community to “redouble their efforts to collect and analyze information” on the origin of the pandemic.  Despite their efforts, in August Biden lamented that “critical information about the origins of this pandemic exists in the People’s Republic of China,” but China “continues to reject calls for transparency and withhold information.”

Censorship is Death of Science and Leads to Death of People America should be a bulwark against it, but it wasn’t during the pandemic. By Jay Bhattacharya

https://amgreatness.com/2023/09/25/censorship-is-death-of-science-and-leads-to-death-of-people/

On May 15, 1970, the New York Times published an article by esteemed Russia scholar Albert Parry detailing how Soviet dissident intellectuals were covertly passing forbidden ideas around to each other on handcrafted, typewritten documents called samizdat. Here is the beginning of that seminal story:

Censorship existed even before literature, say the Russians. And, we may add, censorship being older, literature has to be craftier. Hence, the new and remarkably viable underground press in the Soviet Union called samizdat.

Samizdat – translates as: “We publish ourselves” – that is, not the state, but we, the people.

Unlike the underground of Czarist times, today’s samizdat has no printing presses (with rare exceptions): The K.G.B., the secret police, is too efficient. It is the typewriter, each page produced with four to eight carbon copies, that does the job. By the thousands and tens of thousands of frail, smudged onionskin sheets, samizdat spreads across the land a mass of protests and petitions, secret court minutes, Alexander Solzhenitsyn’s banned novels, George Orwell’s “Animal Farm” and “1984,” Nicholas Berdyayev’s philosophical essays, all sorts of sharp political discourses and angry poetry.

Though it is hard to hear, the sad fact is that we are living in a time and in a society where there is once again a need for scientists to pass around their ideas secretly to one another so as to avoid censorship, smearing, and defamation by government authorities in the name of science.

I say this from first-hand experience. During the pandemic, the U.S. government violated my free speech rights and those of my scientist colleagues for questioning the federal government’s COVID policies.

American government officials, working in concert with big tech companies, defamed and suppressed me and my colleagues for criticizing official pandemic policies – criticism that has been proven prescient. While this may sound like a conspiracy theory, it is a documented fact, and one recently confirmed by a federal circuit court.

In August 2022, the Missouri and Louisiana attorneys general asked me to join as a plaintiff in a lawsuit, represented by the New Civil Liberties Alliance, against the Biden administration. The suit aims to end the government’s role in this censorship and restore the free speech rights of all Americans in the digital town square.

Lawyers in the Missouri v. Biden case took sworn depositions from many federal officials involved in the censorship efforts, including Anthony Fauci. During the hours-long deposition, Fauci showed a striking inability to answer basic questions about his pandemic management, replying “I don’t recall” over 170 times.

Legal discovery unearthed email exchanges between the government and social media companies showing an administration willing to threaten the use of its regulatory power to harm social media companies that did not comply with censorship demands.

Heather Mac Donald: Rational Fears of the Irrational Concerns about future Covid lockdowns are conspiracy theories, insists the New York Times—but what credibility does the paper have to assure anyone?

https://www.city-journal.org/article/rational-fears-of-the-irrational

The New York Times has an updated Covid warning for its readers: “Right-wing influencers and conspiracy theorists are stoking fears about mass lockdowns and spreading unsubstantiated new ideas about Covid-19’s links to world events.” Only a right-wing nutcase, according to the Times, would imagine that policymakers and their media boosters would overreact to the latest round of Covid infections, which the Times and other outlets have been assiduously covering:

To conspiracy theorists and right-wing influencers online, each uptick is an opportunity to sow fear and rile up their supporters, according to disinformation experts. The use of “plandemic” and “scamdemic”—two terms describing Covid-19 as a ruse—rose sharply in August on right-wing websites, according to data from Pyrra, a company that monitors threats and misinformation on alternative social networks.

“I would almost call it an obsession for the Covid denier, anti-vax community,” said Welton Chang, the co-founder and chief executive of Pyrra. “They just make mountains out of molehills for every little thing.”

“Opportunity to sow fear?” “Obsession?” “Mountains out of molehills?” Hypocrisy, thy name is the New York Times!

Who can forget the dozens of banner headlines, in fonts of ever-increasing stridency, trumpeting each new threshold of Covid cases? Who can forget the Times’s daily caseload maps and graphs; the diagrams demonstrating the virus’s allegedly Olympian aerial reach; and the “Those We Lost” Covid obituary page, which never once showed an obese victim and which suggested that 96-year-old decedents were robbed of another decade or more of vibrant life by a Covid infection? Who does not recall the Times’s refusal to distinguish “deaths with Covid” and “deaths from Covid?” Or the paper’s fearful reporting on the innocuous Omicron strain, which quoted terrified New Yorkers as models of appropriate Covid response? Or the weeks of opprobrium piled on South Dakota for allowing an outdoor biker gathering while the Times and public health authorities waxed breathless over the nobility of Black Lives Matter protesters?

The Times cites as an example of “Covid misinformation” the claim that Covid vaccines are causing sudden deaths of young people: “While there is no link between Covid-19 vaccines and sudden deaths, conspiracy theorists have often circulated the idea as celebrities and athletes fall ill from unrelated causes.”

We’re fighting the Covid censors When there is scientific disagreement or uncertainty, the government must never pretend there is consensus and certainty Jay Bhattacharya and Martin Kulldorff

https://thespectator.com/topic/were-fighting-the-covid-censors-censorship/

On July 4, our Independence Day, Judge Terry Doughty issued a preliminary injunction ordering the federal government to immediately cease contact with social media companies, which it had been urging to censor protected free speech. Evidence unearthed in the Missouri v. Biden case, in which we are co-plaintiffs, has revealed a vast federal enterprise dictating to social media companies who and what to censor. The Centers for Disease Control and Prevention (CDC), the Surgeon General’s office, the National Institutes of Health, the FBI, the State Department, the Department of Homeland Security and the White House itself were all closely involved.

You can get a good sense of what ideas the government finds threatening from its priority list of what it does not want Americans to talk about freely: the pandemic, vaccines, wars, concerns about election fraud and Hunter Biden’s laptop.

In the Missouri case, depositions of government officials and the discovery of email exchanges between the government and social media companies show an administration willing to threaten the use of its regulatory power to harm social media companies that do not comply with censorship demands.

Social media companies rely on Section 230 of the Communications Decency Act, which immunizes them against defamation lawsuits that traditional media are subject to. It states, “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” But unlike, for example, a phone company, they may still censor or decline to publish perfectly legal content protected under the First Amendment. For social media companies, losing this protection would threaten their multibillion-dollar business.

The companies understand what is at stake even if the threats are not explicit. But documents adduced in this case sometimes show explicit threats. For instance, at one point, White House communications director Kate Bedingfield announced that “the White House is assessing whether social-media platforms are legally liable for misinformation spread on their platforms, and examining how misinformation fits into the liability protection process by Section 230 of The Communication [sic] Decency Act.” The government’s message to social media companies was unmistakable: comply or else. Internal documents show company employees sometimes trying to push back on censorship demands but then capitulating.

Annals of Government-Run Medicine Socialized health care is failing again. James Freeman

https://www.wsj.com/articles/annals-of-government-run-medicine-d24f4656?mod=opinion_lead_pos11

One of the world’s most celebrated socialized medical systems is doing what socialized medical systems do: limiting patient care. Pending work stoppages could mean that the worst is yet to come for patients of England’s National Health Service.

For obvious reasons, American politicians seeking an even greater federal role in U.S. health care avoid discussing the staggering privations under Marxist regimes in places like Cuba and Venezuela. Instead, pols like Sen. Bernie Sanders (socialist, Vt.) point to government-run health systems within largely free, developed economies. But the U.K. is another example they’ll want to avoid.

Josephine Franks reports for Sky News that senior doctors, called consultants in Britain, will be joining their less experienced colleagues in withholding treatment:

Consultants and junior doctors are set to strike for several more days this week and early next month, bringing more chaos to the NHS after several months of walkouts and delayed appointments…
A health chief said the NHS is in “uncharted territory” due to the strikes, with thousands of patient appointments expected to be cancelled.
Saffron Cordery, deputy chief executive of NHS Providers, said this week’s strike action “can’t become the status quo”.

Sadly it can. If there’s one brutal lesson of government-run health care it’s that things can always get worse. Turning doctors into unionized government bureaucrats brings a host of problems, including the fact that politicians, not patients, decide what doctors are paid. This is of course a problem in the U.S. as well. England is a sort of preview of just how badly government management can mangle the incentives to provide medical services—and the duty to provide care. Ms. Franks continues:

On the picket lines of the March strike, junior doctors told Sky News why they were striking and described having to borrow money off family for medical exams, watching colleagues leave for better paid jobs abroad and how they were struggling to pay rent.

If anyone asks Mr. Sanders to comment, no doubt he will rail about the British government not spending enough, just as his answer to every question about U.S. health care involves a greater burden on taxpayers and fewer free choices for consumers.

To those Relatives and Friends who still Doubt Covid treatments Eileen F. Toplansky

NO URL…THIS IS AN ORIGINAL COLUMN

Jews worldwide are commemorating the Jewish New Year and as they eat their challah and munch on honey and apples, conversations emerge that covid cases are increasing.  Yet, most around the lavishly adorned dining room table still resist any information about ivermectin and the thousands of adverse reactions from the covid “vaccine.” 

Yet, for those who still care about family and friends who may have been kept in deliberate ignorance by Big Pharma, and government leaders, I offer this piece.  Most people believe that in the beginning of the epidemic, there were no good treatment options and that is was sad that so many people passed away.

But there were treatment options early on that were not made available. Unfortunately, the government in tandem with Big Pharma withheld treatment options and as a consequence, thousands of people died who could have been saved. This information is emerging daily and it is a medical scandal of major proportions.  It will ultimately dwarf the DES and Thalidomide scandals of the past.

Early on, I was fortunate enough to read and hear information from informed doctors, many of whom were censored despite their knowledge and expertise. But the more I learned, the more horrified I was of the damage that was and still is being perpetuated on the American people and the world at large.

Thus, I would like to share with you some of the info I learned so you can make up your own mind.  The following hyperlinks will lead you to various sites that have explored this issue.  They are eye-openers.

At Epoch Times, the articles here expose the dangers of more covid vaccines, the actual dangers of wearing masks, and the covid 19 protocols for recovery.

DayQuil, Covid Vaccine Boosters and FDA Science The industry studies that showed a decongestant was effective turned out to be flawed. Sound familiar? By Allysia Finley

https://www.wsj.com/articles/dayquil-covid-vaccine-boosters-and-fda-science-medicine-study-pill-placebo-sick-bb9e457b?mod=opinion_lead_pos6

If DayQuil never seemed to unstuff your nose, now you know why: Its core decongesting ingredient, phenylephrine, doesn’t work.

That’s what a Food and Drug Administration advisory committee unanimously concluded last week, 16 years after researchers first told the agency that evidence from the 1960s and ’70s purportedly demonstrating the ingredient’s efficacy was flawed. For decades, people have been taking what amounts to a placebo.

But unlike a sugar pill, phenylephrine can cause lightheadedness, queasiness, headaches and a rapid heartbeat. What took the FDA so long to act?

Perhaps typical bureaucratic inertia and reluctance to backtrack on “settled science.” This episode mirrors the debate over Covid boosters, which the FDA approved last week, the day before its advisory committee concluded phenylephrine is ineffective. As was the case for phenylephrine, booster recommendations are based on flawed studies and extrapolations.

The FDA concluded in 1994 that phenylephrine was “generally recognized as safe and effective” when administered orally, such as in a cold syrup, “even though the efficacy data were borderline,” according to an agency staff report. Why? Because the ingredient had proved effective when administered intranasally.

Yet studies as early as the 1930s showed that significantly higher doses of phenylephrine than are safe would be needed to have a decongesting effect, since it is mostly metabolized before reaching the bloodstream. At the time, however, the FDA credited positive evidence from poorly constructed industry studies.

When the agency revisited the issue in 2007, an industry meta-analysis of prior flawed studies showed phenylephrine was effective. But as an agency scientific adviser quipped at a regulatory briefing that March, “all meta-analysis is post facto. You only do it if you know you’re going to win.” The FDA then sought more studies to measure the efficacy of higher doses—yet the three placebo-controlled trials between 2015 and 2018 were negative.

In its recent review, FDA staff concluded that early studies demonstrating the drug’s efficacy were flawed and possibly biased. Ten, all from the same industry sponsor, had “multiple methodological and statistical issues” and apparent “data integrity” problems. Two “produced near textbook perfect results that could not be duplicated in other similarly designed studies.”

Dr. Robert Redfield Comes Clean on Government Censorship “We, the people, must hold an overreaching government accountable for violating our most sacred rights” By Lloyd Billingsley

https://amgreatness.com/2023/09/15/dr-robert-redfield-comes-clean-on-government-censorship/

“My position was just tell the American public the truth. There are side effects to vaccines. Tell them the truth and don’t try to package it.”

That was Dr. Robert Redfield, director of the Centers for Disease Control during the administration of Donald Trump. Dr. Redfield recently went on record that the government health bureaucracy tried to quash discussion about the ineffectiveness of Covid vaccines.

“There was such an attempt to not let anybody get any hint that maybe vaccines weren’t foolproof, which, of course, we now know they have significant limitations,” said Redfield, who co-founded the University of Maryland’s Institute of Human Virology and served as the Chief of Infectious Diseases and Vice Chair of Medicine at the University of Maryland School of Medicine.

“I think we should have really confidence and not be afraid to debate the issues that we think are in the public’s interest and just tell the public the truth,” said the former CDC director. This wasn’t the first time Dr. Redfield had been at odds with the government health establishment.

“I’m of the point of view that I still think the most likely etiology of this pathology in Wuhan was from a laboratory, you know, escaped,” Redfield told CNN in 2021. “Other people don’t believe that. That’s fine. Science will eventually figure it out.” After these statements, as Vanity Fair reported, “death threats flooded his inbox,” some from prominent scientists.

“I was threatened and ostracized because I proposed another hypothesis,” Redfield explained. “I expected it from politicians. I didn’t expect it from science.” The people might expect the FBI to investigate death threats against a public official, but reports of any such investigation are hard to find.

In 2021, Joe Biden said he would ask the intelligence community to “redouble their efforts to collect and analyze information that could bring us closer to a definitive conclusion.” The Delaware Democrat ignored a key reality about the pandemic.

The CDC deploys the Epidemic Intelligence Service (EIS), a medical CIA, to prevent epidemics from arriving on American soil. The intrepid EIS officers failed to stop the Covid virus from arriving stateside, and their failure, like the death threats against Redfield, has not been subjected to an investigation. In early 2020, EIS veteran Dr. Nancy Messonnier, the sister of Rod Rosenstein, delivered a series of press briefings that faithfully echoed China’s talking points.

Biden medical advisor Dr. Anthony Fauci headed the National Institute of Allergy and Infectious Diseases (NIAID) for nearly 40 years. Dr. Fauci funded the Wuhan Institute of Virology to conduct gain-of-function research that makes viruses more lethal and transmissible. The WIV, in turn, received shipments of deadly pathogens courtesy of Dr. Xiangguo Qiu, the Chinese national who headed the special pathogens unit at Canada’s National Microbiology Lab.