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FDA Protects Covid-19 Vaccine Makers Seeks Withdrawal Of Competing Dietary Supplement – LewRockwell

Posted by M. C. on May 22, 2021

Another potential cure brushed under the rug?

https://www.lewrockwell.com/2021/05/no_author/fda-protects-covid-19-vaccine-makers-seeks-withdrawal-of-competing-dietary-supplement/

By Bill Sardi with Matthew Sardi

Amazon Appeases FDA Removes Sulfur-Based Dietary Supplement From Online Offerings Because It Cures COVID-19 And Threatens Vaccine Emergency-Use Provisions.

Late last year (2020) the FDA issued a warning letter that a sulfur-based dietary supplement couldn’t be lawfully marketed because it was first studied as a drug in 1963 and marketed in that same year under the trade name Mucomyst to break up mucus accumulation in the upper respiratory tract (bronchus, lung).

The dietary supplement industry legally challenged the FDA over this categorical restriction for use solely as a drug to treat disease to the exclusion of its use to promote health, which is the what dietary supplements are permitted to claim.

See the rest here

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TGIF: FDA Targets Black and Other Minority Smokers | The Libertarian Institute

Posted by M. C. on May 14, 2021

Let’s be clear on what is going down. The central government wants to stop certain minority smokers from indulging their preferences. That’s paternalism pure and simple. Apparently blacks and others who prefer menthol smokes cannot be persuaded to stop, so they will have to be forced–for their own good. A far higher percentage of black smokers than white smokers prefer menthol to unflavored cigarettes.

https://libertarianinstitute.org/articles/sheldon/tgif-fda-targets/

by Sheldon Richman

Just when we are reminded that unnecessary conflict between the police and the people, especially in poorer black communities, is a poison to be eliminated forthwith, the Biden administration has moved in the wrong direction. Late last month the administration signaled that it wants to ban menthol cigarettes, which are especially popular with black smokers.

“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” Acting Food and Drug Administration Commissioner Janet Woodcock said. “With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”

For years the FDA had been pushed on this issue by a coalition of organizations, including some self-identified black advocacy groups, although other similar groups, along with the ACLU, have opposed the ban. The FDA has finally agreed to the ban. It will take time to put it in place because of the public-comment process.

Let’s be clear on what is going down. The central government wants to stop certain minority smokers from indulging their preferences. That’s paternalism pure and simple. Apparently blacks and others who prefer menthol smokes cannot be persuaded to stop, so they will have to be forced–for their own good. A far higher percentage of black smokers than white smokers prefer menthol to unflavored cigarettes.

Strangely, this is occurring during the height of concern about unjustified police violence against black men and women. As we know, product prohibition always prompts the creation of illegal markets, and this breeds a poisonous relationship between police and the communities in which the illegal activities are most likely to occur. The reason couldn’t be simpler. Unlike with crimes of violence against person and property–that is, offenses with victims–vice laws attempt to stop consensual transactions. Since those transactions by nature have no complainant, the police inevitably resort to intrusive, rights-violating methods to catch people in the act. The methods include surveillance, use of dodgy informants with have incentives to lie and set people up, and other trickery. It couldn’t be any other way. If laws against victimless “crimes” are to be enforced, the most egregious enforcement methods will be brought to bear as a matter of necessity. It’s in the very nature of the legal suppression of vice. (I’m including gambling, drugs, prostitution, and so on.)

Considering that minority community trust in the police is is not exactly high, why would anyone want to give the police more authority to root out consensual interaction? It can only make things worse.

Anticipating this criticism, the FDA promises it will not target consumers; only manufacturers and distributors will be in the authorities’ sights. But that statement is misleading. Plenty of damage can be done at the street level if the manufacturers and distributors of illegal menthol cigarettes turn out to be small-scale neighborhood operations, which they may well be. (Why would highly visible Big Tobacco take the risk?) If people demand menthol smokes, other people will creatively cater to their demand. Remember Eric Garner’s fatal encounter with the police when he was illegally selling individual cigarettes (“loosies”) presumably to get around the high New York tobacco tax. In Massachusetts, which has already banned menthol cigarettes, the black market is reported on the rise. When police efforts to stop black-market manufacturers and distributors fail, will the police turn on consumers? Stamping out demand (if it could be done) would surely stamp out supply.

This can’t end well. For one thing, a ban on one product could morph into a ban on other items that contribute to the production of originally targeted product.

And let’s keep in mind the larger context. While the government says it’s trying to save smokers from themselves, it also demonizes vaping and has outlawed most vape flavors. True, the exceptions to that ban (for now?) are tobacco and menthol flavors, but still the FDA has made efforts to scare smokers from switching to vaping, which is known to be much safer than inhaling the smoke from burning tobacco leaves. If smokers are scared away from vaping, many will stick with smoking, menthol or no menthol.

Meanwhile the FDA is also looking into lowering the nicotine content of cigarettes to “nonaddictive levels,” a futile act of mere signaling since smokers could simply smoke more cigarettes to make up their nicotine deficit.

When will government learn? Actually, that’s the wrong question. Officials have no incentive to take seriously many things they must already know because it would cost them their mission, power, and prestige.

Abolition of all vice laws should be step number one in any effort to eliminate unjustified police violence. Forbidding the state’s officers from looking for outlawed but consensual transactions couldn’t help but create a better relationship between the police and the people, especially those in the most vulnerable communities.

(For the case against all laws against victimless crimes, see Lysander Spooner’s Vice Are Not Crimes.)

About Sheldon Richman

Sheldon Richman is the executive editor of The Libertarian Institute, senior fellow and chair of the trustees of the Center for a Stateless Society, and a contributing editor at Antiwar.com. He is the former senior editor at the Cato Institute and Institute for Humane Studies, former editor of The Freeman, published by the Foundation for Economic Education, and former vice president at the Future of Freedom Foundation. His latest books are Coming to Palestine and What Social Animals Owe to Each Other.

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Improper Amounts of Aluminum Discovered In Multiple Childhood Vaccines – Collective Evolution

Posted by M. C. on May 14, 2021

The Takeaway: The politicization of science has become quite a large issue these days. In my opinion, science that seems to support a narrative that is in favour of  certain government and/or corporate interests is heavily promoted and explored, while science that calls these narratives into question is heavily scrutinized, censored and unacknowledged within the mainstream.

https://www.collective-evolution.com/2021/05/12/renowned-scientist-petitions-fda-about-improper-amounts-of-aluminum-in-childhood-vaccines/

ByArjun Walia

In Brief

  • The Facts:A team of aluminum experts at Keele University has found that multiple childhood vaccines contain significantly more or less aluminum than what is listed on product labels. They have filed a petition with the FDA in an attempt to resolve this issue.
  • Reflect On:What are the consequences of misleading or incorrect product information, like vaccines, listed on the product label? Should these labels not be completely accurate?
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Before you begin…

Take a moment and breathe. Place your hand over your chest area, near your heart. Breathe slowly into the area for about a minute, focusing on a sense of ease entering your mind and body. Click here to learn why we suggest this.

The aluminium adjuvant that’s used in multiple childhood vaccines has come under the scrutiny of multiple scientists from around the world over the past couple of years. It’s been discovered that a number of these vaccines have far more or far less aluminum adjuvant than listed on their FDA approved product labels, and as a result two formal petitions (access them here and here) were filed with the FDA on May 4th and May 6th of this year. advertisement – learn more

The petitions demand that the agency do its job and assure that vaccine manufacturers are disclosing accurate information about the amount of aluminum adjuvant that’s actually present in their childhood vaccines. You can access the most recent legal update, here.

–> Become A CE Member: The only thing that keeps our journalism going is YOU. CE members get access to exclusive benefits and support our shared mission.. Click here to learn more!

A team of the world’s foremost experts in aluminum toxicology, led by Christopher Exley (initiator of the petition), a Professor of Bioinorganic Chemistry for the last 29 years with more than 200 published peer reviewed articles regarding aluminum, made this discovery. Six vaccine products contained statistically significant greater amounts of aluminum (Pentacel, Havrix, Adacel, Pedvax, Prevnar 13, and Vaqta) and four childhood vaccines were found to contain a statistically significant lower quantity of aluminum adjuvant than what is outlined on the label for these products (Infanrix, Kinrix, Pediarix, and Synflorix.

This discovery was published in The Journal of Trace Elements in Medicine and Biology where researchers point to the fact that since aluminum is a known toxin in humans and specifically a neurotoxin, it’s content in vaccines should be accurate and independently monitored to ensure both efficacy and safety.

Another paper of interest for readers might be this one, titled The role of aluminum adjuvants in vaccines raises issues that deserve independent, rigorous and honest science. It also outlines the concerns being raised.

The petition states, advertisement – learn more

These deviations from the products’ labels are extremely concerning. Doses with more than the approved amount of aluminum adjuvant raise serious safety concerns, and doses with less than the approved amount raise questions regarding efficacy. Indeed, aluminum adjuvant is a known cytotoxic and neurotoxic substance used to induce autoimmunity in lab animals, and which numerous peer-reviewed publications implicate various autoimmune conditions….These deviations also render the products and manufacturers not in compliance with various federal statutes and regulations, requiring immediate action from the FDA.

The Petitions therefore demand that the FDA immediately and publicly release documentation sufficient to establish that the aluminum content in each vaccine at issue is consistent with the amount provided in its labeling and that the FDA pause distribution of the vaccines at issue until it has done so.

  Nothing can be more important than the safety of vaccines injected into babies.

If you would like to provide the FDA a comment regarding the petitions filed regarding aluminum levels in childhood vaccines, you can do so here and here.

Exley and his work is supported by many scientists from around the world, yet he is facing a potential set back with regards to continuing his research on aluminum and disease. One hundred scientists came together and recently wrote a letter of support, stating,

We are writing to express our concern over the possible interruption of research on aluminum and disease conducted by Christopher Exley and his group in your (Keele) University. We feel that Christopher Exley’s work conducted for so many years in line with the previous research of late Pr Birchall at Keele University has been an important service to the scientific community, patients and society in Europe and globally. We firmly declare that Pr Exley has always defended rigorous research independent of commercial conflicts of interest, and has freely carried out his research without any control by any of his sponsors.

You can read more about what’s going on with regards to this situation, and access the correspondence that’s happened between Keele University (Exley’s employer), Exley, and the academics who support his work, here.

Exley has provided his own comment on the petition that reads as follows,

Once these data on the aluminium content of infant vaccines were known to me I asked myself about their absolute significance. What were the data witnessing. Sloppy processing by manufacturers? If so then why weren’t these issues flagged up by internal auditing of the products? Do manufacturers not actually measure the final content of aluminium in their vaccines? It looks that way. If they do not are they still assuming that the information they give on the patient information leaflet is accurate? Presumably they are as this amount of aluminium per dose of vaccine has been extensively researched and optimised by the manufacturer to give the antibody titre necessary for the vaccine to be effective. Since the vaccine is wholly ineffective in the absence of the aluminium adjuvant then the amount of aluminium adjuvant injected into the infant must be tightly controlled in providing a safe and effective vaccine. Isn’t that correct?

How can vaccine manufacturers be so complacent about such a critical issue? Is there a darker side to all of this? It may or it may not be true that manufacturers carefully optimise the aluminium content of infant vaccines. However, how often do manufacturers monitor the efficacy of their vaccine in receiving infants? How do they know that the data they must have for their clinical trials is reproduced in real time vaccinations in infants. Simply, how do they know that their vaccine works against its target disease? Do they even care? These data on the aluminium content of infant vaccines suggest very strongly that from the moment the vaccine is aliquoted to its vial ready for subsequent administration to an infant the manufacturer has no interest in whether it is either effective or safe.

No one is monitoring the former and vaccine manufacturers have no responsibility for the latter. Vaccine manufacturers are businesses first and foremost, it is not up to them to make sure that their products are safe and effective. It is the responsibility of the FDA and the FDA is clearly neglecting this responsibility as is the European Medicines Agency. A cartel of neglect and complacency that puts infants all of the world at risk, not only from the disease the vaccine is meant to be effective against but critically from the injection of an unknown amount of a known neurotoxin into vulnerable infants.

I know that many of you have given me your support in a myriad of ways and I am eternally thankful. You may be interested to know that the ‘academic’ Aluminium Family has also played a part and you can read all about this through this link. If you have any questions or comments about this please direct them to Professor Romain Gherardi (RKG75@protonmail.com) who kindly instigated this effort on my behalf.

The Takeaway: The politicization of science has become quite a large issue these days. In my opinion, science that seems to support a narrative that is in favour of  certain government and/or corporate interests is heavily promoted and explored, while science that calls these narratives into question is heavily scrutinized, censored and unacknowledged within the mainstream.

If science is raising a cause for concern, especially regarding something like aluminum toxicity that is so prevalent in our lives today, why can’t we as a society embrace, support, and acknowledge the study of it openly and collectively? What is going on here? You might imagine that everybody would support research like the kind Exley and his team are doing, as it only seeks to make a healthier world. Then again,  it may not be in the best interest of pharmaceutical companies and their business model.

Isn’t human health and ‘doing no harm’ the key oath public health is interested in upholding? The implications of science should not impede progression of health, but rather accelerate it.

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FDA: “Operation Quack Hack”: Medical Mafia vs. Medical Health Freedom Fighters – Activist Post

Posted by M. C. on May 12, 2021

https://www.activistpost.com/2021/05/fda-operation-quack-hack-medical-mafia-vs-medical-health-freedom-fighters.html

By Maryam Henein

“The past was erased, the erasure was forgotten, the lie became truth.” 1984, George Orwell

IRONY ALERT! “No form of human misery can be allowed to go unexploited, and the coronavirus pandemic is no exception.” WebMD

Under the guise of safety (read: control) and fueled by a narrative that COVID-19 is a pandemic devastating the world, the U.S. government has issued a veritable witch hunt against online health professionals and natural ancient remedies like silver, vitamin C, magnesium, and mineral salts (MMS).

Headed by the Food and Drug Administration (FDA), Operation Quack Hack is cyberstalking and softly terrorizing hundreds of doctors and health professionals who actually care about bolstering people’s health. And yes, “Operation Quack Hack” is the actual name the FDA has given this operation.

They laugh. We pay.

While the groundwork for this pharmaceutical and governmental overreach started long ago with the advent of Rockefeller medicine, the “Rona Regime” gets carte blanche. It is remarkable to consider that even the CDC data illustrates this virus is less fatal than the flu, with a 99.7% recovery rate.

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Quack Hack in full effect

When I reached out to the FDA via email, Press Officer Jeremy Kahn confirmed that “Operation Quack Hack” was launched in March 2020 in response to “scammers on the internet selling products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19 in violation of the Federal Food, Drug, and Cosmetic Act.” I was unable to locate a press release announcing this particular Covid-related “effort.”

Kahn also educated me as to how the FDA came up with the name “Quack Hack.”

“People who peddle false cures, medical charlatans, are commonly referred to a ‘quacks.’ Here, ‘hack’ was meant to refer to using various approaches to disrupt the activities of those who are selling false cures on the internet.”

Um, Excuse me? I wondered.

Professionals in the health space know NOT to use the “C” word, which in this case is “Cure.” Most providers openly declare their products will not cure COVID-19, but now the FDA frowns upon words like “treat” or “prevent” used in the same sentence as “coronavirus.” Such a transgression is enough to trigger warning letters.

As a result of what can be described as arguable attacks, some who have been targeted have suffered strokes, had their homes raided, their sons arrested, and woken up to find their company website disabled at the server level, a business of twenty-plus years gone in a flash (more horrid details later).

Quack Hack is headed by the Center for Drug Evaluation (CDER), a division of the FDA that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER reportedly “performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.”

CDER employs around 1,300 employees in “review teams” that evaluate and approve new drugs. Additionally, CDER features a “safety team” with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product’s labeling. CDER was run by Dr. Janet Woodcock before she went on this May to lead the “therapeutic” initiative at Operation Warp Speed.

The FDA’s overall budget for approving, labeling, and monitoring drugs is roughly $290 million per year. Of that, the CDER’s safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year.

CDER, currently run by Acting Director Dr. Patrizia Cavazzoni, oversees more than just medicines. For example, they consider fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens as “drugs.” Who knew? And when did they start deeming nutrients like vitamin C as “drugs”?

Meanwhile, a kitchen sink of agencies collaborates on catching “quacks,” including the Cybercrime Investigations Unit and the Office of Regulatory Affairs Health Fraud Team within the FDA’s Office of Regulatory Affairs, as well as the Department of Justice and the Federal Trade Commission (FTC).

Some participants apparently have not been strict enough. According to Democrat Sen. Chuck Schumer, the FTC, for instance, needs to take the gloves off and “crackdown.”

See the rest here

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The FDA Botched Covid Testing in 2020. Nothing Has Changed Since Then. | Mises Wire

Posted by M. C. on January 28, 2021

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab.

https://mises.org/wire/fda-botched-covid-testing-2020-nothing-has-changed-then

Dave Albin

Ah, the covid-19 test results—much maligned by some and worshipped by others! As part of the ongoing covid-19 pandemic, the results of covid-19 tests are repeatedly blasted at us from many places, often with analysis. It is easy to understand why this is the case. News media and information outlets of all types can present the absolute numbers of positive tests and data trends, which are easy to find, and many viewers can seemingly grasp what’s happening and where. And people are concerned about the spread of a novel virus and what it might do to them, their families, and their communities. In short, this is information that people demand. As such, they will get it.

It’s important to understand the basics of the two main types of tests being used to detect the virus. First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19. Second, an antibody test is used to detect the presence of an antigen (often a specific protein) that is present on the outside of a pathogen like covid-19. Both of these tests take biological processes and manipulate them to detect the presence of something specific—in these cases, markers of covid-19. There’s nothing magical or sacred about what’s happening. Anyone with the supplies and proper training can run these tests and report findings. And, like with any analytical procedure, there are restrictions on what can be detected. False positives and false negatives are possible, detection levels have limits, and sampling technique affects the results. All of these can be examined to better define the accuracy of the results.

And, yet, as concerns about covid-19 were rapidly increasing, many people were without this vital information that they wanted. Why was this? In the US, the Food and Drug Administration has authority over all medical testing, and in times of emergency, what is known as emergency authorized use, or EUA, can be granted so that labs around the country can begin testing. However, due to bureaucracy and red tape, the FDA took weeks, rather than days, to grant EUAs (another way of saying that it was slow to give up a little authority) so that testing could begin. It was even reported that the FDA and state authorities instructed one lab to halt their plans of repurposing existing tests for covid-19 testing. (By the way, history is already being rewritten, so it seems.) Some labs reported being ready to give results, with validated testing protocols in hand, but being forced to wait due to the FDA’s slow response time. Thus, critical time was lost; people were flying blind for weeks as fear increased.

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab. Reviewing documents or protocols is largely ceremonial if the “experts” don’t have a clear understanding of the procedures and, more importantly, if they are not in the labs with the technicians performing the tests. Who knows if the tests are being administered properly, or if, following employee turnover, a new staff member is poorly trained and improperly gives the tests? This last scenario cannot ever be tracked and controlled by regulators.

These regulatory challenges would have been much better addressed with private sector testing facilities competing for customers. In order for a testing lab to be chosen by eager customers, its results have to be meaningful—those that do not provide this will not be in business for long. 

In addition, a private testing system would have allowed quicker data sharing sooner (and the use of various platforms) and for testing to be conducted in a way that pleases customers. In some areas, the reporting would have been different, but ultimately it would have had to satisfy customers. And with something like a global pandemic, broader sharing of information would likely have been welcomed at first and might have changed later—the market could have decided over time. Competing evidence would even have served as an important quality control.

It’s a good bet that an approach like the one outlined here would have mediated the effects of the covid-19 pandemic. There’s no question (with the benefit of hindsight) that covid-19, and the response to it, was going to cause difficulty and suffering for many people. Lives have been lost, businesses and services derailed, and trust eroded. But, with the right information in hand, decision-making would have been improved. Trouble areas and practices could have been avoided. Personal risk could have been assessed more accurately. We could have understood what was happening sooner and worked to get through the covid-19 pandemic more quickly. Instead, we’re left with the same stagnant, bloated system that’s slow to respond—troubling because other pathogens are sure to arise in the future. We can’t afford to stumble in the darkness again. Author:

Contact Dave Albin

Dave Albin conducts process development research and provides technical support for a food equipment manufacturer in Iowa.

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FDA — Captured and Corrupt

Posted by M. C. on October 22, 2020

FDA — Captured and Corrupt

By Joseph Mercola

Mercola.com

If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.

The agency itself certainly tries to present itself as independent from the industries it regulates but, in reality, legal loopholes have led to the FDA receiving money from, and being captured and corrupted by, private interests.

While the FDA itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which in turn receives money from other nonprofits funded by private interests. It’s really all a façade because the end result is the same. Those donating the money ultimately end up with the ability to pull strings, when needed.

The Reagan-Udall Foundation…

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The Absolutely Essential Question To Ask Before Consenting to Any Vaccination – What Is the Number Needed To Vaccinate (NNV)? – LewRockwell

Posted by M. C. on September 28, 2020

https://www.lewrockwell.com/2020/09/gary-g-kohls/the-absolutely-essential-question-to-ask-before-consenting-to-any-vaccination-what-is-the-number-needed-to-vaccinate-nnv/

By

“An overwhelming majority of the FDA officials directly charged with licensing vaccines, and the CDC officials who effectively mandate them for children, have personal financial entanglements with vaccine manufacturers. These ‘public servants’ are often shareholders in, grant recipients from, and/or paid consultants to vaccine manufacturers, and, occasionally, even patent holders of the very vaccines they vote to approve. Those conflicts of interest motivate them to recommend ever more vaccines with minimal support from evidence-based science” – Robert F. Kennedy, Jr.

“The FDA receives 45% of its annual budget from the pharmaceutical industry. The World Health Organization (WHO) gets roughly half its budget from private sources, including Pharma and its allied foundations. And the CDC, frankly, is a vaccine company; it owns 56 vaccine patents and buys and distributes $4.6 billion in vaccines annually through the Vaccines for Children program, which is over 40% of its total budget.” — Robert F. Kennedy, Jr

“The HHS (Health and Human Services) partners with vaccine makers to develop, approve, recommend, and pass mandates for new products and then shares profits from vaccine sales. HHS employees can personally collect up to $150,000 annually in royalties for products they work on. For example, key HHS officials collect money on every sale of Merck’s controversial HPV vaccine Gardasil, which also yields tens of millions annually for the agency in patent royalties.” — Robert F. Kennedy, Jr

“In 1986, Congress—awash in Pharma money (the pharmaceutical industry is number one for both political campaign contributions and lobbying spending on legislators over the past 20 years) enacted a law granting vaccine makers blanket immunity from liability for injuries caused by vaccines. The subsequent gold rush by pharmaceutical companies boosted the number of recommended inoculations from twelve shots of five vaccines in 1986 to 54 shots of 13 vaccines today. A billion-dollar sideline grew into the $50 billion vaccine industry behemoth.” — Robert F. Kennedy, Jr

“Since vaccines are liability-free – and effectively compulsory to a captive market of 76 million children – there is meager market incentive for companies to make them safe. The public must rely on the moral scruples of Merck, GlaxoSmithKline, Sanofi, and Pfizer. But these companies have a long history of operating recklessly and dishonestly, even with (the drug) products for which they can be sued for injuries. The four companies that make virtually all of the recommended vaccines are all convicted felons.  Collectively they have paid over $35 billion since 2009 for defrauding regulators, lying to and bribing government officials and physicians, falsifying science, and leaving a trail of (incurable chronic illness) injuries and deaths from products they knew to be dangerous and still sold under pretense of safety and efficacy.” – Robert F. Kennedy, Jr

The title question of this column is a trick question, for neither the Trump administration’s Operation Warp Speed, Big Pharma, the Bill & Melinda Gates Foundation, the World Health Organization, Dr Fauci’s CDC, the Mainstream Media, your local physicians, your local pharmacies nor your local hospitals or clinics will be able to answer it!!

Since informed consent by any patient to any prescribed treatment that is being offered by a licensed medical practitioner (who supposedly takes and adheres to the Hippocratic Oath) is a universal human right, the question isn’t just an ivory tower, academic one that can be skipped over. It is a life-and-death issue. Hence, being totally informed about the significant risks and often meager benefits of vaccination. Therefore, given the fact that the current powers that be that are attempting to profit from mass vaccinations in the near future, I offer the following information.

This column is amended from one that I wrote in 2018 for the Duluth Reader. It can be read here.

________________________________________________________________________

The Number Needed to Vaccinate (NNV) is similar to the Number Needed to Treat (NNT) for pharmaceutical drugs), in that it says, in one phrase, how many patients will need to be vaccinated (or treated) for one patient to benefit from the vaccine or drug. The larger the number, the worse the effectiveness of the vaccine (or drug). I list just a few examples below.

Unfortunately – but predictably, since much of what is published is authored by Big Pharma-co-opted academicians, career public health officials, research scientists, epidemiologists and statisticians, the vast majority of journal articles intentionally omits NNV or NNT statistics.

This article contains statistical information that Big Pharma, Big Vaccine and Big Medicine tries not to publish and which the Big Pharma-co-opted Big Media also never talks about – for obvious reasons.

Googling Number Needed to Vaccinate (NNV), Number Needed to Treat (NNT), Number Needed to Harm (NNH), Relative Risk Reduction (RRR) and Actual Risk Reduction (ARR) is important in decoding the massive propaganda campaigns over the past few decades that have been so cunning at

1] “selling sickness”,

2] popularizing “germophobia”,

3] selling increasingly unaffordable, highly-profitable and dangerous drugs,

4] promoting vaccines that have not been adequately tested for-long-term safety OR long-term efficacy, and

5] over-selling profitable “epidemics” and “pandemics” for the purpose of acquiring power, control and wealth for those cunning entities that already have too much ruling power and obscene amounts of wealth.

Of course, the massive amounts of published “research” that comes from the labs of Big Pharma-influenced public health bureaucrats or Big Pharma-hired “scientists” in medical journal articles must be viewed with a large amount of skepticism, only partly because of the virtually incurable conflicts of interest that have been created – because of the close financial and collegial relationships – between the following groups:

1] the career bureaucrats at the HHS, the NIH, the CDC, the NIAID, the FDA,

2] the many hired (and therefore biased) scientists that work for profiteering pharmaceutical/vaccine corporations,

3] the decision-making, Big Pharma-bribed politicians that rely on advice from Big Pharma-employed “scientists”,

4] the Global Multi-millionaire and Billionaire Investment Class members and their assorted Family Foundations that have acquired a lot of their wealth from investments in the pharmaceutical and vaccine industries, and

5] the Mainstream Media that is dependent on advertising revenues from Big Pharma, thus inevitably censoring the dissident voices of independent scientists that are courageous enough to speak truth to power.

 

Read these few examples and then demand more information and the right to fully informed consent over what gets injected into the muscles of our infants, children and adults and thus what also affects the DNA, the lymphatic systems, the immunologic systems, the bone marrow, the gastrointestinal systems, the microbiome, the circulatory systems and the peripheral and central nervous systems of the current and next generations of humanity. Read the rest of this entry »

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Erie Times E-Edition Article-How some regulation can help markets function better

Posted by M. C. on September 12, 2020

When there are information asymmetries, market participants need some minimum level of assurances – provided and enforced by a credibly independent arbiter, such as the government…

Credibility=government – Catherine Rampell is either delusional or someone’s hack. I suspect the latter.

The only reason companies demand government regulation is to make competition too complex and expensive for smaller companies, or labs in this case.

There is a reason car companies don’t complain about emissions requirements and multiple crash tests from every direction for new car designs.
https://erietimes-pa-app.newsmemory.com/?publink=0f7598765

Regulate us – please. That’s what big pharmaceutical companies are implicitly begging the Trump administration to do, because of a public crisis of confidence in any forthcoming COVID19 vaccine. The plea is surprising on its face. It also rebuts the GOP’s entire understanding of regulation – specifically, that regulation is necessarily bad for businesses, consumers and economic growth.

Since the spring, the administration has hyped miracle cures for COVID19, regardless of what’s known about their efficacy or risks: hydroxychloroquine, bleach, convalescent plasma, whatever that MyPillow guy is hawking lately. Recently, President Donald Trump suggested that a vaccine could, conveniently, come to market just before Election Day.

Meanwhile, his Food and Drug Administration commissioner said he was prepared to authorize a vaccine early.

Americans are understandably apprehensive.

Six in 10 Americans worry political pressure from the administration will lead the FDA to rush vaccine approval before confirming it’s safe and effective, the Kaiser Family Foundation has found. And only about four in 10 would get the vaccine, even if it were free, if the FDA approved it before the election.

Fearful that these suspicions might reduce the market for a drug tremendous resources have gone into developing, Big Pharma took an unusual step Tuesday.

The chief executives of nine drug companies publicly pledged to ‘make the safety and well-being of vaccinated individuals the top priority in development of the first COVID19 vaccines.’ Moreover, they vowed not to seek FDA approval before vaccine safety and efficacy had been established in Phase 3 trials – the industry standard – implying that they would do this even if the Trump administration allowed (or encouraged) them to cut corners.

This pledge reflects several notable developments.

One is how much damage Trump has inflicted upon the perceived credibility of public health institutions, as he has upon the National Weather Service, Census Bureau and other independent agencies.

Another is that drug companies – which historically have sought fewer restrictions and faster approval from the FDA – once complained that the bar for bringing new drugs to market was too high. Now they worry that bar appears too low.

This is not the first time the Trump administration has sought to lower the regulatory bar in the name of helping industry and boosting economic growth even when industry objected. See, for example, its rollback of rules regulating methane emissions, automotive fuel-efficiency standards and mercury pollution. These actions were opposed by companies the administration claimed to be helping.

Recent vaccine regulatory jockeying underscores the flaw in the GOP narrative that regulation and economic activity are inversely related – that is, less regulation always means more economic growth.

When there are information asymmetries, market participants need some minimum level of assurances – provided and enforced by a credibly independent arbiter, such as the government – for markets to function. If you don’t trust the party on the other side of a transaction not to cheat or otherwise harm you, you’ll be less likely to engage in the transaction. (This observation is not original to me; an economics Nobel was awarded for it two decades ago.) Regulation, in other words, can be pro-market. It can facilitate the trust necessary for more economic activity to occur. After all, it would be virtually impossible for consumers to independently assess whether the beef at their local grocery store is untainted; whether a used car is fatally defective; or whether their local bank will keep their deposits safe. Yelp stars alone are no substitute for capital requirements.

Alas, the administration’s response to the pandemic has included rolling back more rules and relaxing enforcement of rules still on the books – including those related to public health. Lax government oversight threatens to hold back not just the market for vaccines but other industries affected by the pandemic, too. For instance, airlines say they’re requiring masks aboard. But absent a governmentenforced mandate, customers who see, say, viral photos of disobedient passengers might question whether the policy is actually enforced. And they might just stay home.

There’s a libertarianfriendly alternative to this worldview, one that also happened to win a Nobel Prize: Rather than using strict regulations to ensure honorable behavior, strong property rights and the frictionless ability to sue over those rights could theoretically achieve the same end.

That is, if companies know consumers will win redress for fraud or injury, that threat should sufficiently incentivize quality and safety.

Presumably, Mitch McConnell and Trump believe such policies help the economy. But the fewer consumers who trust either government or corporations to ‘do the right thing,’ the longer it will take for public health – and the economy – to recover. Catherine Rampell is a Washington Post columnist. Email her at crampell@washpost.com.

Catherine Rampell

Be seeing you

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Landmark FDA Paper On Aluminum Safety In Vaccines Found To Have A Critical Math Error – Collective Evolution

Posted by M. C. on September 10, 2020

https://www.collective-evolution.com/2020/09/09/landmark-fda-paper-on-aluminum-safety-in-vaccines-found-to-have-a-critical-math-error/

By

In Brief

  • The Facts:A group of scientists and physicians known as The Physicians For Informed Consent (PIC) have discovered a crucial math error in a FDA paper regarding the safety of aluminum in vaccines.
  • Reflect On:Why have there been no studies by regulatory agencies in conjunction with independent scientists to see where vaccine ingredients travel to in the body after the are injected? Why no appropriate safety testing for the aluminum vaccine adjuvant?

What Happened: The Physicians For Informed Consent (PIC) outline that the U.S. Food and Drug Administration (FDA) and the Agency for Toxic Substances and Disease Registry (ATSDR), which is a division of the U.S. Department of Health and Human Services (HHS) have already raised concerns about the negative effects of aluminum exposure in humans.

They state the following:

–> Help Support CE: Bcome a member of CETV and get access to exclusive news and courses to help empower you to become an effective changemaker. Also, help us beat censorship! Click here to join.

 Because some vaccines contain aluminum, the FDA published a paper in 2011 (Mitkus et al.) to address concerns about aluminum exposure from vaccines in infants. The paper compared the aluminum exposure from vaccines in infants to a safety limit of oral aluminum determined by the ATSDR. However, this study incorrectly based its calculations on 0.78% of oral aluminum being absorbed into the bloodstream rather than the value of 0.1% used by the ATSDR in its computations. As a result, the FDA paper assumed that nearly 8 (0.78%/0.1%) times more aluminum can safely enter the bloodstream, and this led the authors to incorrectly conclude that aluminum exposure from vaccines was well below the safety limit.

You can read their “Erratum in “Updated aluminum pharmacokinetics following infant exposures through diet and vaccination” here.

The Physicians for Informed Consent (PIC) are a group of doctors and scientists from around the world who have come together to support informed consent when it comes to mandatory vaccine measures. Their information is based on science. Their mission is to deliver data on infectious diseases and vaccines, and to unite doctors, scientists, healthcare professionals, attorneys, and families who support voluntary vaccinations. Their vision is that doctors and the public are able to evaluate the data on infectious diseases and vaccines objectively and voluntarily engage in informed decision-making about vaccination.

According to Dr, Christopher Shaw, a member of PIC and a professor at the University of British Columbia who has performed numerous studies on the effects of injected aluminum,

“We knew that the Mitkus et al. paper modeling aluminum clearance had to be inaccurate since it was assuming that injected aluminum kinetics were the same as the kinetics of aluminum acquired through diet. Now, in addition, we see that they did their modeling based on using the incorrect level of aluminum absorption. What is particularly striking is that despite all these errors, since 2011, Mitkus et al. is used by CDC and other entities as the basis for claiming that aluminum adjuvants are safe.”

Dr. Shira Miller, president of PIC, said, “We posted the Mitkus 2011 erratum on ResearchGate in hopes of bringing it to the attention of scientists and researchers who are interested in the safety of the quantities of injected aluminum found in childhood vaccines and would be in a position to further research the safety concern.”

When you inject aluminum, it goes into a different compartment of your body. It doesn’t come into that same mechanism of excretion. So, and of course it can’t because that’s the whole idea of aluminum adjuvants, aluminum adjuvants are meant to stick around and allow that antigen to be presented over and over and over again persistently, otherwise you wouldn’t put an adjuvant in in the first place. It can’t be inert, because if it were inert it couldn’t do the things it does. It can’t be excreted because again it couldn’t provide that prolonged exposure of the antigen to your immune system.- Shaw

The PIC has released a PDF called Aluminum Vaccine Risk Statement with a lot more information. You can access it here.

Why This Is Important: The idea that it’s safe to inject children with aluminum containing vaccines is based on presumption. No appropriate safety studies exist to show this is the case, which is why A group of scientists from multiple countries recently published a paper in the Journal of Trace Elements in Medicine and Biology titled “The role of aluminum adjuvants in vaccines raises issues that deserve independent, rigorous and honest science”  state the following,

 “The safety of aluminium-based vaccine adjuvants, like that of any environmental factor presenting a risk of neurotoxicity and to which the young child is exposed, must be seriously evaluated without further delay, particularly at a time when the CDC is announcing a still increasing prevalence of autism spectrum disorders, of 1 child in 54 in the USA.”

The publication goes on to address concerns it has with another paper that was published a year prior, emphasizing that the authors of that specific publication, JP Goullé & L Grangeot-Keros,

Described general knowledge on aluminum (Al) exposure, kinetics and toxicity but made very little effort to delineate the scientific questions specifically related to Al adjuvants in vaccines. Instead of representing the bulk of their review, the subject of Al adjuvants covered no more than one third of the 3 page-text. Numerous important papers on the topic were omitted, i.e. 20 years of scientific publications in clinical, post-mortem, in vitro and in vivo experimental studies published by independent research teams, worldwide experts in this topic, were simply omitted.

 

Read the rest of this entry »

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FDA Wants To Ban NAC Now That It Combats Covid-19 – LewRockwell

Posted by M. C. on September 4, 2020

It’s worth noting that the number needed to treat (NNT) in the study8 cited by Debé is 0.5, which means for every two people treated with NAC, one will be protected against symptomatic influenza.

That’s significantly better than influenza vaccines, which have an NNV (number needed to vaccinate) of 71,9 meaning 71 people must be vaccinated to prevent a single case of confirmed influenza. It’s even better than vitamin D, which has an NNT of 33.10 Even among those with severe vitamin D deficiency at baseline, taking vitamin D still had an NNT of 4.

https://www.lewrockwell.com/2020/09/joseph-mercola/fda-wants-to-ban-nac-now-that-it-combats-covid-19/

By

Mercola.com

N-acetylcysteine (NAC) has a long history of use as a first-aid remedy for acetaminophen poisoning. Emergency room physicians will administer it in cases when you’ve taken an overdose of Tylenol or other acetaminophen products. The way it neutralizes the toxic effects of the drug is by recharging glutathione, thereby preventing liver damage.

Interestingly, NAC may also be useful against COVID-19, as explained by pulmonologist Dr. Roger Seheult in the MedCram lecture above. By raising glutathione, it helps combat oxidative stress, which is a main factor in the cytokine storm associated with COVID-19.

A recent literature analysis1 linked glutathione deficiency to COVID-19 disease severity, leading the author to conclude that NAC may be useful both for prevention and treatment. NAC may also combat the abnormal blood clotting seen in many cases, and helps loosen thick mucus in the lungs.

FDA Cracks Down on NAC

Interestingly, with COVID-19 treatment as a new indication, the U.S. Food and Drug Administration is now suddenly cracking down on NAC, claiming it is excluded from the definition of a dietary supplement, as it was approved as a new drug in 1985.2 As such, NAC cannot be marketed as a supplement.

You certainly would not suspect this looking at the supplement market. As reported by Natural Products Insider,3 there are no fewer than 1,170 NAC-containing products in the National Institutes of Health’s Dietary Supplement Label Database.

Be that as it may, July 29, 2020, FDA announced4 it has issued warning letters to seven companies that market NAC as a remedy for hangovers. According to the FDA:

“A hangover can occur after alcohol intoxication. Alcohol intoxication, like all poisonings, causes dose-related dysfunction and damage, ranging from mild impairments to death … The products outlined in these letters, which are labeled as dietary supplements, are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.”

Members of the Council for Responsible Nutrition have expressed concern that the warning letters may indicate the FDA is considering targeting NAC more widely.

While the FDA makes no mention of COVID-19 in its warning letter, the timing of its crackdown on NAC marketed for hangovers is interesting, seeing how news of its potential benefits against the viral infection have come into circulation, and research is now underway to assess whether it might be used in the treatment of COVID-19.

At present, seven studies involving NAC for COVID-19 are listed on Clinicaltrials.gov.5 Time will tell whether the FDA ends up trying to block access to NAC supplements, similarly to the way hydroxychloroquine access has been stifled.

NAC Inhibits Viral Replication

The idea that NAC can be helpful against viral infections is not new. Previous studies have found it reduces viral replication of certain viruses, including the influenza virus. As reported by board-certified nutritionist Joseph Debé:6

“NAC was tested in a 6-month human study7 of influenza. It was a randomized, double-blind, placebo controlled trial involving 262 people. Half of the subjects received 600 mg of NAC, the other half received placebo, twice daily for 6 months.

NAC was found to improve immune function and reduce the severity of influenza infections. Both groups had similar infection rates with A/H1N1 virus influenza. However, whereas 79% of placebo-treated people had symptomatic infections, only 25% of subjects treated with NAC were symptomatic!

There were a total of 99 flu-like episodes (symptomatic periods) that occurred in 62 people in the placebo group over the 6 month study. 48% of these were classified as mild, 47% were moderate, and 6% were severe.

In the NAC group, 46 flu-like episodes occurred in 37 subjects. 72% of these were mild, 26% were moderate and only 2% severe. There were many fewer days of being bedridden in the NAC group.”

It’s worth noting that the number needed to treat (NNT) in the study8 cited by Debé is 0.5, which means for every two people treated with NAC, one will be protected against symptomatic influenza.

That’s significantly better than influenza vaccines, which have an NNV (number needed to vaccinate) of 71,9 meaning 71 people must be vaccinated to prevent a single case of confirmed influenza. It’s even better than vitamin D, which has an NNT of 33.10 Even among those with severe vitamin D deficiency at baseline, taking vitamin D still had an NNT of 4.

NAC Inhibits Proinflammatory Cytokines

NAC has also been shown to inhibit the expression of pro-inflammatory cytokines in cells infected with highly pathogenic H5N1 influenza virus. According to the authors of such a study:11

“The antiviral and anti-inflammatory mechanisms of NAC included inhibition of activation of oxidant sensitive pathways including transcription factor NF-kappaB and mitogen activated protein kinase p38 …

NAC inhibits H5N1 replication and H5N1-induced production of pro-inflammatory molecules. Therefore, antioxidants like NAC represent a potential additional treatment option that could be considered in the case of an influenza A virus pandemic.”

Proinflammatory cytokines play a crucial role in COVID-19 severity. Researchers have confirmed that in severe cases, cytokines such as interleukin-6 (IL6), interleukin-10 (IL10) and TNF-ɑ are all elevated.12 Once they reach excessive levels, a so-called cytokine storm develops, causing significant tissue damage. NAC may be able to inhibit this damaging cascade.

NAC — Potential Therapeutic Agent for SARS-CoV-2

A paper13 published in the October 2020 issue of Medical Hypotheses reviews the potential therapeutic benefits of NAC in the battle against COVID-19 specifically. According to the authors:

“COVID-19 … continues to spread across the globe. Predisposing factors such as age, diabetes, cardiovascular disease, and lowered immune function increase the risk of disease severity.

T cell exhaustion, high viral load, and high levels of TNF-ɑ, IL1β, IL6, IL10 have been associated with severe SARS-CoV-2. Cytokine and antigen overstimulation are potentially responsible for poor humoral response to the virus.

Lower cellular redox status, which leads to pro-inflammatory states mediated by TNF-ɑ is also potentially implicated. In vivo, in vitro, and human clinical trials have demonstrated N-acetylcysteine (NAC) as an effective method of improving redox status, especially when under oxidative stress.

In human clinical trials, NAC has been used to replenish glutathione stores and increase the proliferative response of T cells. NAC has also been shown to inhibit the NLRP3 inflammasome pathway (IL1β and IL18) in vitro, and decrease plasma TNF-ɑ in human clinical trials.

Mediation of the viral load could occur through NAC’s ability to increase cellular redox status via maximizing the rate limiting step of glutathione synthesis, and thereby potentially decreasing the effects of virally induced oxidative stress and cell death.

We hypothesize that NAC could act as a potential therapeutic agent in the treatment of COVID-19 through a variety of potential mechanisms, including increasing glutathione, improving T cell response, and modulating inflammation.”

A second report14 reviewing the evidence for using NAC in the treatment of COVID-19 was published April 14, 2020, by The Centre for Evidence-Based Medicine at the University of Oxford.

How NAC May Protect Against COVID-19 Read the rest of this entry »

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