gene editing

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by Silviu “Silview” Costinescu

We’ve all heard of existing cancer cures, whether you believe in them or not, you can’t rationally hope they will be made available to plebs for as long a Pharmafia exists.

Goldman Sachs asks in biotech research report: ‘Is curing patients a sustainable business model?’

CNBC, APR 11 2018

Yuri Arcurs | Getty Images

Goldman Sachs analysts attempted to address a touchy subject for biotech companies, especially those involved in the pioneering “gene therapy” treatment: cures could be bad for business in the long run.

“Is curing patients a sustainable business model?” analysts ask in an April 10 report entitled “The Genome Revolution.”

“The potential to deliver ‘one shot cures’ is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies,” analyst Salveen Richter wrote in the note to clients Tuesday. “While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.”

Biotech shares soar on dealmaking, drug progress

Richter cited Gilead Sciences’ treatments for hepatitis C, which achieved cure rates of more than 90 percent. The company’s U.S. sales for these hepatitis C treatments peaked at $12.5 billion in 2015, but have been falling ever since. Goldman estimates the U.S. sales for these treatments will be less than $4 billion this year, according to a table in the report.

“Gilead is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients,” the analyst wrote. “In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise.”

The analyst didn’t immediately respond to a request for comment.

The report suggested three potential solutions for biotech firms:

“Solution 1: Address large markets: Hemophilia is a $9-10bn WW market (hemophilia A, B), growing at ~6-7% annually.”

“Solution 2: Address disorders with high incidence: Spinal muscular atrophy (SMA) affects the cells (neurons) in the spinal cord, impacting the ability to walk, eat, or breathe.”

“Solution 3: Constant innovation and portfolio expansion: There are hundreds of inherited retinal diseases (genetics forms of blindness) … Pace of innovation will also play a role as future programs can offset the declining revenue trajectory of prior assets.”

So you don’t see anyone pushing for any cures.

CONSUMER AFFAIRS

Biden’s moonshot examined: Researchers say cancer cure is a long ways off

By ERIN SCHUMAKER and RUTH READER / Politico / 02.10.2023

The White House is pressing ahead, saying a combination of research on cures and prevention efforts will end the scourge.

Congress has appropriated $1.8 billion for the “cancer moonshot” President Joe Biden began in 2016, and the positive reaction to Biden’s request for more suggests it’s eager to maintain the momentum. | Evan Vucci/AP Photo

President Joe Biden’s pledge to “end cancer as we know it” is a rare sliver of common ground between Democrats and Republicans.

Congress has appropriated $1.8 billion for the “cancer moonshot” Biden began in 2016, and the positive reaction to Biden’s request for more during Tuesday’s State of the Union suggests it’s eager to maintain the momentum.

But cancer researchers are less unified about the moonshot than Washington policymakers. A contrarian cadre question whether the money appropriated is being well spent. Cancer research is funded well enough, they said, and investing more in high-tech individualized treatments is more likely to help the wealthy live longer than it is to save those most likely to die of the disease: the poor and people of color.

“It’s a lot harder than getting a man to the moon,” Gilbert Welch, an internist and senior investigator at the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, said of curing cancer. “It’s a very complex set of diseases. You need to think of it as a family of diseases. The moon is just one thing. Just gotta get there. This is hundreds of different things.”

Biden wants to press ahead on a bipartisan initiative. He has called on Congress to maintain funding for the 2016 law that launched the moonshot, the 21st Century Cures Act. He pledged to cut cancer death rates by 50 percent in the next 25 years and to turn fatal cancers into treatable diseases.

Biden also has asked Congress to reauthorize the National Cancer Act, signed into law by President Richard Nixon in 1971. Reauthorization would help the National Cancer Institute support researchers around the country by building clinical trial networks and more robust data systems, according to Danielle Carnival, the White House’s moonshot coordinator.

But some experts, such as Ezekiel Emanuel, an oncologist, a professor at the University of Pennsylvania and former White House adviser, said there’s plenty of money devoted to cancer research. The National Cancer Institute had a nearly $6.4 billion budget for cancer research in 2021 and its annual spend has been growing since 2015. Cancer non-profits like the American Cancer Institute also raise hundreds of millions of dollars every year.

President Richard Nixon speaks.
President Joe Biden has asked Congress to reauthorize the National Cancer Act, signed into law by President Richard Nixon in 1971. | AP Photo

Additionally, the pharmaceutical industry is incentivized to put money behind increasingly lucrative cancer diagnostics and therapeutics. Research shows that from 2010 to 2019 revenue generated from cancer medicines increased 70 percent among the top 10 pharmaceutical companies to reach $95 billion.

And not everyone thinks more funding is a good thing. “There’s so much money sloshing around,” Welch said of the cancer industry, adding, “Both academic and biotech or industry are excessively enthusiastic and just trying to put out as many products as they can.”

We’ve overinvested in cancer, according to Welch, especially in expensive cancer drugs with modest or unproven benefit for patients and in screenings — Welch’s research area. He’s particularly opposed to the Medicare Multi-Cancer Early Detection Screening Coverage Act, sponsored by Sen. Mike Crapo (R-Idaho) and Rep. Terri Sewell (D-Ala.), which would require Medicare to cover cancer blood tests if they’re approved by the FDA. From Welch’s vantage point, benefits from screenings have been exaggerated, while its harms have been minimized.

Other critics, such as Keith Humphreys, a public health professor at Stanford University who has published academic articles on the link between alcohol use and cancer, see cancer prevention as a more immediate way to save lives.

Managing disease and curing it

The president’s agenda goes beyond money, Carnival told POLITICO, emphasizing prevention efforts, such as improving nutrition for kids, discouraging smoking, and decreasing environmental risks.

“We’re going to have to reach more people with the tools we already have and those we develop along the way,” Carnival said. “The purview is much broader than research. I don’t think anyone would say we have all of the research advancements and knowledge and treatments that we need today to end cancer as we know it.”

Those closely involved in developing cutting-edge cancer therapeutics said the field has shifted dramatically in recent years. It’s gone from treating cancer as a chronic disease, to trying to cure patients.

During his medical fellowship in the early 2000s, improving patient survival by months or years was the goal, explained Marco Davila, a physician-scientist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., who helped pioneer some of the first CAR-T cell therapies for patients with blood cancer.

Since then, treatment breakthroughs for some previously incurable cancer have upended the cancer-as-chronic-disease philosophy. Now, doctors and researchers believe cancer-curing therapies are within reach. “It’s changed the nature of how we manage patients. There’s that option there. It’s on the table,” Davila said.

For Davila, moonshot funds earmarked for cancer research and therapies created a new pool of money for his work. It doesn’t fix the problem of underfunded science as a whole, he said, but it makes his work as a cancer researcher a priority.

“It’s great for us, because that’s our field. It’s also great for patients, because cancer is still going to be one of the most common causes of people’s death in the United States,” Davila said. (In the U.S., it’s second behind heart disease, taking more than 600,000 lives in 2020, the most recent year for which there are statistics.)

Indeed, since the late 1980s, scientists have developed effective treatments for lung cancer, breast cancer and Hodgkin’s lymphoma. There are caveats, of course. They don’t work for all patients.

“It’s maybe 20 percent, 30 percent,” Davila said. The goal now is to keep improving those cure rates over time — to 50 percent or 60 percent, for example.

“Will it get to 100 percent in your lifetime? I don’t know,” he said.

What Davila does know is that each 10 percent cure-rate increase means saving tens of thousands, or even hundreds of thousands of lives.

‘Prevention takes action’

But some cancer experts said there’s a downside to the shift toward precision medicine and individualized treatments. Attempting to test everyone or characterize every tumor more precisely is a bit of magical thinking, according to Welch.

“The more you subset people, the more difficult it is to know whether your treatments help. It’s too small of a group,” Welch said. “It used to be just lung cancer. Now we’ve got eight genetic variants we’re testing in adenocarcinomas of the lung,” he added.

“Ironically, the more precise we get, the more types of cancer there are, as we genetically signature each cancer, all of a sudden we don’t really know what to do with any one of them.”

Others think there needs to be a fundamental shift away from screening and treatment and toward preventing cancer in the first place.

“It’s terrific when we develop new treatments for cancer, but it certainly is always better to prevent something than to treat it,” said Humphreys, who served as a drug policy adviser under Presidents George W. Bush and Barack Obama.

“Very high-end, complicated treatments are never going to be accessible to the whole population,” he added. “Congress could definitely do more.”

“We have very good evidence that when we raise the federal alcohol tax that fewer people die.”

Keith Humphreys, public health professor at Stanford University

Tobacco taxation is widely considered one of the most effective practices in preventing people from starting to smoke in the first place, leading existing smokers to quit, and reducing deaths from tobacco-related cancers. Humphreys said Congress could take the same taxation approach to the alcohol industry. “We have very good evidence that when we raise the federal alcohol tax that fewer people die,” he said.

While broad blood-based cancer screening may not be a cost-effective strategy for stopping cancer early, targeted cancer screening for colorectal, breast, cervical, prostate, and lung cancers could be. Rules could stoke participation or ensure that patients on Medicaid, who are more likely to be at risk of cancer, are getting regular screenings.

“It’s important to acknowledge that our biggest success in cancer really reflects prevention,” Welch said. “It’s nothing fancy. It’s discouraging cigarette smoking.”

Following a surgeon general warning in the 1960s about the health risk of smoking, and subsequent anti-smoking campaigns, tobacco use — and later lung cancer rates — plummeted.

Ezekiel Emanuel speaks
There’s a lot of money already in the moonshot cancer system. It just needs to be redirected and allocated differently, said Ezekiel Emanuel, an oncologist and former White House adviser.

The White House touts prevention in its moonshot agenda. In 2022, the first year of the reignited moonshot, the FDA proposed rules to prohibit menthol cigarettes. Among other agenda items, the moonshot program plans to increase cancer screenings in at-risk communities and facilitate donations of sunscreen to schools and youth organizations.

But prevention is a trickier cancer-prevention mechanism than treatment. It could mean cleaning up Superfund sites or removing lead pipes to reduce environmental cancer risk. It often requires people to change their behavior — to drink less alcohol and exercise more or stop smoking — a more challenging mission at the population level than directing patients to take a pill or offering them a diagnostic test.

“It’s not necessarily clear how one spends money on prevention,” Welch acknowledged. “It’s much easier to sell a test or a drug. It’s a concrete thing. Prevention takes action on the part of individuals,” he said. “You gotta say, that’s harder.”

More funding wouldn’t necessarily solve the problem, according to Emanuel.

There’s a lot of money already in the system. It just needs to be redirected and allocated differently, Emanuel explained.

Who is spending that money also matters. The government sponsors roughly one-third of clinical cancer research, according to Emanuel. Industry accounts for the remaining two-thirds of funding. “It’s good that they’ve got a lot of drugs that they’re testing. What’s bad is having industry shape the clinical research agenda, because industry has a bias.”

Emanuel’s solution: stronger government leadership and more non-industry sponsors.

“The NCI [National Cancer Institute] is the biggest NIH institute,” Emanuel said. “It’s not exactly like they’re starving.”

You also have to be a monster to sell halving the cases long after your death as a “cure”

Biden keeps rambling about curing cancer because he and Obama set up and funded the delusional mRNA industry, which was initially aimed at cancer. The Moderna guys promised him this and he ran with it. He still does, poor dumb fv<k…

Learn more here: OBAMA, DARPA, GSK AND ROCKEFELLER’S $4.5B B.R.A.I.N. INITIATIVE – BETTER SIT WHEN YOU READ

and here: SCANDALOUS! YOUTUBE JUST SCRUBBED MODERNA CHIEF SCIENTIST’S TED TALK ABOUT MRNA AND GENES. FOR “MEDICAL MISINFORMATION”

THIS DUDE DUPED AT LEAST THREE US PRESIDENTS

And if you have a MAGA hat, don’t flash it before reading this:

To be continued?
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by Silviu “Silview” Costinescu

The only thing worse than genocide is irreversibly compromising the human genetics with incalculable consequences for all current and future generations.
And, once again, we bring proof they are knowingly doing this, and where there’s awareness, there’s also intention.
So this video below should open the Nuremberg 2 trials.

The WEF published this video in 2016, one year prior to Moderna’s Tal Zaks video for TED that we’ve already manage to make quite viral.
This crucial issue is hugely underrated and most people still are not so sure what to believe simply because The Military Biotech Complex is burning the books through its Big Tech arm.
Hopefully the video before clarifies the issue for good.

Before we further discuss this, please see this “prequel” for very important context:

SCANDALOUS! YOUTUBE JUST SCRUBBED MODERNA CHIEF SCIENTIST’S TED TALK ABOUT MRNA AND GENES. FOR “MEDICAL MISINFORMATION”

Actually, one of our first videos deleted by YouTube was just scientists describing their work in the field of epigenetics and epitratrascriptomics, a whole science dedicated to editing DNA using RNA as a screwdriver. See:

RNA USED TO ALTER DNA, BRAIN FUNCTIONS AND BEHAVIOR (BIOHACKING P.2)

And then came these:

WE WRITE NEW DNA USING RNA ONLY – FATHER OF THE HUMAN GENOME PROJECT FINANCED BY EPSTEIN, DARPA AND SCHWAB’S WYSS INST.

BREAKING! PFIZER IS PARTNERING WITH GENE-EDITING COMPANIES TO CORRECT YOUR DNA – CEO ALBERT BOURLA

Now that we are on the same page, in terms of information, I’d like to go back to our new video, there’s a few key points that I’d like to stress:

  • They’ve been in the know since Day 1, this is not a surprising side effect, it’s the effect they pursued.
  • The above implies intention
  • Obviously they have no clue what this will lead to, other than genetic chaos. In the words of Bill Gates “If you want to see the effects after two years, you need to wait two years”. How about 20 or 200 years?
  • Cherry on the cake – the newest revelations: 50% truncated mRNA that no one has any clue what it does
  • All of the above is potentially irreversible, definitive and transmissible to the future generations. We have no clue what’s going to happen, but your grand-grand-grand kids may all suffer from it. Even if you’re a pure blood, you can get contaminated a million ways.
    AND THAT’S WHAT’S WORSE THEN GENOCIDING A GENERATION IN ONE COUNTRY OR ANOTHER.

Which brings me to another crucial question I launched in the public square long ago, without any satisfactory response:

You all know DNA is described as made of two protein spirals. If you take one and you break it to pieces, the result is hardly different from RNA or their description of a virus.
In which case I would love an expert to explain:

What happens to the DNA debris resulted from cell death, where does it go and can it be mistaken for viruses? Are infections and diseases actually auto-immune attacks?

Here’s a possible starting point:

Mechanisms and physiology of the clearance of dead cells by efferocytosis

Emilio Boada-Romero,1 Jennifer Martinez,2 Bradlee L. Heckmann,1,† and Douglas R. Green1,†

Nat Rev Mol Cell Biol. 2020 Jul; 21(7): 398–414.

Published online 2020 Apr 6. doi: 10.1038/s41580-020-0232-1

“Unlike PAMPs, which are derived from microbes, damage-associated molecular patterns (DAMPs) are of cellular origin and can be liberated upon cell death. DAMPs trigger inflammatory responses, and may also serve as chemoattractants for macrophages. DAMPs are metabolically diverse entities, including genomic and mitochondrial DNA, nuclear proteins (HMGB, histones)25, cytoplasmic proteins (S100), cytokines (IL-1α, IL-33, IL-36), and other small molecules (ATP, UTP, uric acid crystals) (Table 1)26. In addition, inflammasome [G] -mediated caspase-1 activation generates inflammatory cytokines IL-1β and IL-18 during pyroptosis (see Box 1) that lead to inflammatory immune activation after cellular demise.27 Below, we review the relevance of DAMPs during efferocytosis, the ability of DAMPs to modulate inflammation, and specific DAMPs and their effects.

DNA as a DAMP. 

Several mechanisms ensure low DNA burden following apoptotic death and contribute to its immune-silent phenotype. In healthy cells, caspase-activated DNase (CAD) exists in complex with its inhibitory chaperone ICAD and remains constitutively inactive in the cytosol28,29. Active caspase-3 cleaves ICAD28,30, promoting CAD homodimerization, nuclear translocation, and DNA hydrolysis between nucleosomes. Nuclear pieces are then neatly packaged with cytoplasm into apoptotic bodies that are eventually digested during efferocytosis31. In contrast, nuclear and mitochondrial DNA (mtDNA), as well as pathogen-derived DNA molecules in those cells dying due to an infection, can be released to the extracellular environment from non-apoptotic dying cells. Toll-like receptor 9 (TLR9) is activated by unmethylated CpG sequences such as those found in mtDNA or bacterial DNA (Table 1), and activation of TLR9 triggers downstream inflammatory responses. circulating DNA DAMPs can accumulate in the body in cases where non-apoptotic cell death is widespread; for example, mtDNA was found to be elevated in the plasma of trauma patients32, likely as a result of injury-induced cell death.

DNA in the extracellular environment is processed by DNase-I33, while DNase-III (also known as TREX1) clears cytoplasmic DNA34, and DNase-II processes DNA from dying cells in the phagocyte’s lysosomes to help maintain negligible levels of DNA following efferocytosis. Should DNA escape to the cytosol, it can be recognized by cytosolic DNA sensors35, including cyclic GMP-AMP synthase (cGAS) and the inflammasome component AIM2. cGAS is activated upon cytosolic DNA binding and subsequently catalyzes a reaction between GTP and ATP to form cyclic GMP-AMP (cGAMP)36. The newly synthesized cGAMP binds to and activates the stimulator of interferon genes protein (STING), leading to TANK binding kinase 1 (TBK1)-dependent phosphorylation of the interferon regulatory factor IRF337. These events trigger the IRF3-mediated activation of a Type I interferon response.

DNase-II-deficient or DNase III-deficient mice die during embryogenesis and this embryonic lethality can be prevented if the response to misplaced DNA is abrogated through deletion of cGAS, STING, or the Type-I interferon receptor (IFNAR)38–41. It is possible that these DNases function to limit cytosolic DNA following efferocytosis during development, thereby preventing this lethal interferonopathy, although how the DNA of engulfed corpses might be released from the phagosome or lysosome to become cytosolic, triggering such responses, remains unknown.

Similarly, recognition of cytosolic DNA by AIM2 causes AIM2 to recruit and activate caspase-1, resulting in IL-1β processing and release, contributing to inflammation42,43. Again, when and how defects in the clearance of DNA during efferocytosis may engage AIM2 remains unclear.

Protein DAMPs. 

High mobility group protein B1 (HMGB1) is a nuclear protein that binds to DNA and assists replication, repair and transcription44,45,46. Although some HMGB1 can be released to the extracellular milieu under steady state conditions47 or during apoptosis48, it is predominantly released during forms of immunogenic cell death25. Efficient efferocytosis can thus limit the release of HMGB1. Based on its redox status, HMGB1 can function as a chemotactic agent (reduced) or as an inflammatory agent (oxidized)49. In its reduced form, HMGB1 can prevent the induction of immune tolerance [G] to antigens associated with the dying cell48. Reduced HMGB1 may bind to TLRs or the receptor for advanced glycation end products (RAGE) (Table 1)50, leading to immune cell activation and cytokine production. Recently, binding of reduced HMGB1 to the chemokine receptor CXCR4 was observed during tissue regeneration following injury51, highlighting the possible importance of this molecule in the response to dying cells. S100 proteins can also be released from dying cells52, and efferocytosis can limit the release of these proteins from dying cells. Again, TLRs and RAGE appear to be the primary receptors on macrophages that promote inflammatory activation in response to S100 proteins.”

Efferocytosis is critical for tissue homeostasis.Efferocytosis can be carried out by professional phagocytes (red boxes), such as macrophages and dendritic cells, or to a lesser extent by non-professional phagocytes (blue boxes) such as epithelial cells. Disruption of normal efferocytosis can contribute to the development of a wide range of pathologies (light grey boxes) across a variety of tissues. (dark grey boxes). COPD, chronic obstructive pulmonary disease; IPD, idiopathic pulmonary disease; SLE, systemic lupus erythematosus.

I keep my expectations low, but please surprise me!

To be continued?
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GRAB IT!

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by Silviu “Silview” Costinescu

Why do we even need science and media investigations, or even a Justice system and police investigators, since YouTube can easily arbiter debates as complex and specific as mRNA technology vs. your genetic code?!

First, please watch the short bombshell video that got scrubbed, as it was uploaded in YouTube too, an unmissable “gem” in itself, even without the censorship scandal :

Here’s a Moderna-produced video for the Moderna website, confirming Moderna’s chief scientist three years later:

Can we cure genetic diseases by rewriting DNA? | David R. Liu – TED 2019

More “medical misinformation”?

Moderna: We created our jab in 2 days! Pfizer: LOL N00bs!
https://silview.media/2021/04/14/vaccine-companies-never-had-the-virus-in-their-labs-just-a-memo-from-china-top-industry-insider/

Bonus: TheirTube penalized not only Zaks, but mostly users who followed and spread TheirScience, TheirScientists, TheirAuthoritativeSources


How do I know this?
Because I am the one that unearthed this video about two years ago and has worked hard to viralize it. Quite successfully I’d say, it was the most viewed from our channel, I think it was approaching 200,000 views last time I checked, which was a long time ago anyway. But it’s up on other platforms too and other users mirrored it from us, it made several rounds of the Internet and was just blowing up again on Facebook. I’ve seen it deleted multiple times from multiple platforms. So I guess it became too unbearable for the Borg.

NOTICE THAT THE VIDEO THUMBNAIL IS A SCREEN-SHOT OF THE ORIGINAL YOUTUBE UPLOAD, AND THAT’S INTENTIONAL!
IT WAS THE SAME HOW I DID IT ON YOUTUBE, SO THEY KNEW WHAT THEY DELETE WHEN THEY DELETED IT.
I used another title to bring the video into the 2021 actuality, but kept the original. My title only highlighted another relevant quote from Zaks.
This was my one and only intervention in that content.

By the way, I have no control over what’s going on on that channel, because these nitwits deleted my YouTube account completely, for similar crimes, but kept up the orphaned channel.

Btw, this exact scenario happened before, more than once, this is how we lost a few channels and YouTube accounts:

How Ice Ages Happen – The Milankovitch Cycles – Published by NASA, banned by YouTube
May 28, 2021:
Losers Utd – When you have more $billions than braincells, you just buy yourself a deeper grave
More info: https://silview.media/2021/05/27/i-havent-seen-more-self-ownage-since-the-dawn-of-internet/

so i can’t even begin to tell you how important it is to spread this info right now, so we can take advantage of the censorship debates and INSERT IN THE PUBLIC AGENDA THE TOPIC of genetic modification by covid jabs!

To be continued?
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ORDER

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by Silviu “Silview” Costinescu

We warned you that giving these people free access to your body is a bad idea, for they will take advantage to put in and take out all sorts of things you don’t know about. Just like they do with everything else.

If you’ve been around for a while, this doesn’t really surprise you, but it’s a valuable confirmation and we can move over with this discussion.

If not, you definitely need to catch up with this too:

BGI – BILL GATES’ & BIG TECH’S CHINESE DARLINGS: WORLD’S TOP DNA HARVESTERS, CLONERS, UIGHUR PERSECUTERS (BIOHACKING P.4)

To be continued?
Our work and existence, as media and people, is funded solely by our most generous supporters. But we’re not really covering our costs so far, and we’re in dire needs to upgrade our equipment, especially for video production.
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DETAILS / ORDER

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by Silviu “Silview” Costinescu

Take it with a pinch of salt, as per usual, this still a product of MIT.

Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

Stephanie Seneff1 and Greg Nigh – Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge MA, 02139, USA, E-mail: seneff@csail.mit.edu / Naturopathic Oncology, Immersion Health, Portland, OR 97214, USA

ABSTRACT

Operation Warp Speed brought to market in the United States two mRNA vaccines, produced by Pfizer and Moderna. Interim data suggested high efficacy for both of these vaccines, which helped legitimize Emergency Use Authorization (EUA) by the FDA.

However, the exceptionally rapid movement of these vaccines through controlled trials and into mass deployment raises multiple safety concerns. In this review we first describe the technology underlying these vaccines in detail.

We then review both components of and the intended biological response to these vaccines, including production of the spike protein itself, and their potential relationship to a wide range of both acute and long-term induced pathologies, such as blood disorders, neurodegenerative diseases and autoimmune diseases.

Among these potential induced pathologies, we discuss the relevance of prion-protein-related amino acid sequences within the spike protein. We also present a brief review of studies supporting the potential for spike protein “shedding”, transmission of the protein from a vaccinated to an unvaccinated person, resulting in symptoms induced in the latter.

We finish by addressing a common point of debate, namely, whether or not these vaccines could modify the DNA of those receiving the vaccination. While there are no studies demonstrating definitively that this is happening, we provide a plausible scenario, supported by previously established pathways for transformation and transport of genetic material, whereby injected mRNA could ultimately be incorporated into germ cell DNA for transgenerational transmission.

We conclude with our recommendations regarding surveillance that will help to clarify the long-term effects of these experimental drugs and allow us to better assess the true risk/benefit ratio of these novel technologies.

Introduction

Unprecedented. This word has defined so much about 2020 and the pandemic related to SARS-CoV-2. In addition to an unprecedented disease and its global response, COVID-19 also initiated an unprecedented process of vaccine research, production, testing, and public distribution (Shaw,

2021). The sense of urgency around combatting the virus led to the creation, in March 2020, of Operation Warp Speed (OWS), then-President Donald Trump’s program to bring a vaccine against COVID-19 to market as quickly as possible(Jacobs and Armstrong, 2020). OWS established a few more unprecedented aspects of COVID-19.

First, it brought the US Department of Defense into direct collaboration with US health departments with respect to vaccine distribution (Bonsell, 2021).

Second, the National Institutes of Health (NIH) collaborated with the biotechnology company Moderna in bringing an unprecedented type of vaccine against infectious disease to market, one utilizing a technology based on messenger RNA (mRNA) (National Institutes of Health, 2020).

The confluence of these unprecedented events has rapidly brought to public awareness the promise and potential of mRNA vaccines as a new weapon against infectious diseases into the future. At the same time, events without precedent are, by definition, without a history and context against which to fully assess risks, hoped-for benefits, safety, and long-term viability as a positive contribution to public health.

In this paper we will be briefly reviewing one particular aspect of these unprecedented events, namely the development and deployment of mRNA vaccines against the targeted class of infectious diseases under the umbrella of “SARS-CoV-2.

”We believe many of the issues we raise here will be applicable to any future mRNA vaccine that might be produced against other infectious agents, or in applications related to cancer and genetic diseases, while others seem specifically relevant to mRNA vaccines currently being implemented against the subclass of corona viruses. While the promises of this technology have been widely heralded, the objectively assessed risks and safety concerns have received far less detailed attention. It is our intention to review several highly concerning molecular aspects of infectious disease-related mRNA technology, and to correlate these with both documented and potential pathological effects.

UNPRECEDENTED

Many aspects of Covid-19 and subsequent vaccine development are unprecedented for a vaccine deployed for use in the general population.

Some of these includes the following.

  1. First to use PEG (polyethylene glycol) in an injection (see text)

2. First to use mRNA vaccine technology against an infectious agent

3. First time Moderna has brought any product to market

4. First to have public health officials telling those receiving the vaccination to expect an adverse reaction

5. First to be implemented publicly with nothing more than preliminary efficacy data (see text)

6. First vaccine to make no clear claims about reducing infections, transmissibility, or deaths

7. First coronavirus vaccine ever attempted in humans

8. First injection of genetically modified polynucleotides in the general population

Vaccine Development

Development of mRNA vaccines against infectious disease is unprecedented in many ways. In a 2018 publication sponsored by the Bill and Melinda Gates Foundation, vaccines were divided into three categories: Simple, Complex, and Unprecedented (Young et al., 2018). Simple and Complex vaccines represented standard and modified applications of existing vaccine technologies.

Unprecedented represents a category of vaccine against a disease for which there has never before been a suitable vaccine. Vaccines against HIV and malaria are examples. As their analysis indicates, depicted in Figure 1, unprecedented vaccines are expected to take 12.5 years to develop. Even more ominously, they have a 5% estimated chance of making it through Phase II trials (assessing efficacy) and, of that 5%, a 40% chance of making it through Phase III trials (assessing population benefit). In other words, an unprecedented vaccine was predicted to have a 2% probability of success at the stage of a Phase III clinical trial. As the authors bluntly put it, there is a “low probability of success, especially for unprecedented vaccines.” (Young et al., 2018)

Figure 1.Launching innovative vaccines is costly and time-consuming, with a low probability of success, especially for unprecedented vaccines (adapted from Young et al, 2018).

With that in mind, two years later we have an unprecedented vaccine with reports of 90-95% efficacy (Baden et al. 2020). In fact, these reports of efficacy are the primary motivation behind public support of vaccination adoption (U.S. Department of Health and Human Services, 2020). This defies not only predictions, but also expectations.

The British Medical Journal(BMJ) may be the only prominent conventional medical publication that has given a platform to voices calling attention to concerns around the efficacy of the COVID-19 vaccines. There are indeed reasons to believe that estimations of efficacy are in need of re-evaluation. Peter Doshi, an associate editor of the BMJ, has published two important analyses (Doshi 2021a, 2021b) of the raw data released to the FDA by the vaccine makers, data that are the basis for the claim of high efficacy. Unfortunately, these were published to the BMJ’s blog and not in its peer-reviewed content. Doshi, though, has published a study regarding vaccine efficacy and the questionable utility of vaccine trial endpoints in BMJ’s peer reviewed content (Doshi 2020).

A central aspect of Doshi’s critique of the preliminary efficacy data is the exclusion of over 3400 “suspected COVID-19 cases” that were not included in the interim analysis of the Pfizer vaccine data submitted to the FDA. Further, a low-but-non-trivial percent of individuals in both Moderna and Pfizer trials were deemed to be SARS-CoV-1-positive at baseline despite prior infection being grounds for exclusion. For these and other reasons the interim efficacy estimate of around 95% for both vaccines is suspect.

A more recent analysis looked specifically at the issue of relative vs. absolute risk reduction. While the high estimates of risk reduction are based upon relative risks, the absolute risk reduction is a more appropriate metric for a member of the general public to determine whether a vaccination provides a meaningful risk reduction personally. In that analysis, utilizing data supplied by the vaccine makers to the FDA, the Moderna vaccine at the time of interim analysis demonstrated an absolute risk reduction of 1.1% (p= 0.004), while the Pfizer vaccine absolute risk reduction was 0.7% (p<0.000) (Brown 2021).

Others have brought up important additional questions regarding COVID-19 vaccine development, questions with direct relevance to the mRNA vaccines reviewed here.

For example, Haidere, et. al. (2021) identify four “critical questions” related to development of these vaccines, questions that are germane to both their safety and their efficacy:

•Will Vaccines Stimulate the Immune Response?

•Will Vaccines Provide Sustainable Immune Endurance?

•How Will SARS-CoV-2 Mutate?

•Are We Prepared for Vaccine Backfires?

Lack of standard and extended preclinical and clinical trials of the two implemented mRNA vaccines leaves each of these questions to be answered over time. It is now only through observation of pertinent physiological and epidemiological data generated by widescale delivery of the vaccines to the general public that these questions will be resolved. And this is only possible if there is free access to unbiased reporting of outcomes –something that seems unlikely given the widespread censorship of vaccine-related information because of the perceived need to declare success at all cost.

The two mRNA vaccines that have made it through phase 3 trials and are now being delivered to the general population are the Moderna vaccine and the Pfizer-BioNTech vaccine.

The vaccines have much in common. Both are based on mRNA encoding the spike protein of the SARS-CoV-2 virus. Both demonstrated a relative efficacy rate of 94-95%. Preliminary indications are that antibodies are still present after three months. Both recommend two doses spaced by three or four weeks, and recently there are reports of annual booster injections being necessary (Mahose, 2021). Both are delivered through muscle injection, and both require deep-freeze storage to keep the RNA from breaking down. This is because, unlike double-stranded DNA which is very stable, single-strand RNA products are apt to be damaged or rendered powerless at warm temperatures and must be kept extremely cold to retain their potential efficacy (Pushparajah et al., 2021).

It is claimed by the manufacturers that the Pfizer vaccine requires storage at -94 degrees Fahrenheit (-70 degrees Celsius), which makes it very challenging to transport it and keep it cold during the interim before it is finally administered. The Moderna vaccine can be stored for 6 months at -4 degrees Fahrenheit (-20 degrees Celsius), and it can be stored safely in the refrigerator for 30 days following thawing (Zimmer et al., 2021).

Two other vaccines that are now being administered under emergency use are the Johnson & Johnson vaccine and the AstraZeneca vaccine. Both are based on a vector DNA technology that is very different from the technology used inthe mRNA vaccines.

While these vaccines were also rushed to market with insufficient evaluation, they are not the subject of this paper so we will just describe briefly how they are developed. These vaccines are based on a defective version of an adenovirus, a double-stranded DNA virus that causes the common cold.

The adenovirus has been genetically modified in two ways, such that it cannot replicate due to critical missing genes, and its genome has been augmented with the DNA code for the SARS-CoV-2 spike protein. AstraZeneca’s production involves an immortalized human cell line called Human Embryonic Kidney (HEK) 293, which is grown in culture along with the defective viruses (Dicks et al., 2012).

The HEK cell line was genetically modified back in the 1970s by augmenting its DNA with segments from an adenovirus that supply the missing genes needed for replication of the defective virus (Louis et al., 1997).

Johnson & Johnson uses a similar technique based on a fetal retinal cell line. Because the manufacture of these vaccines requires genetically modified human tumor cell lines, there is the potential for human DNA contamination as well as many other potential contaminants.

The media has generated a great deal of excitement about this revolutionary technology, but there are also concerns that we may not be realizing the complexity of the body’s potential for reactions to foreign mRNA and other ingredients in these vaccines that go far beyond the simple goal of tricking the body into producing antibodies to the spike protein.

In the remainder of this paper, we will first describe in more detail the technology behind mRNA vaccines. We devote several sections to specific aspects of the mRNA vaccines that concern us with regard to potential for both predictable and unpredictable negative consequences.

We conclude with a plea to governments and the pharmaceutical industry to consider exercising greater caution in the current undertaking to vaccinate as many people as possible against SARS-CoV-2.

READ / DOWNLOAD THE FULL PAPER IN PDF

Conclusion

Experimental mRNA vaccines have been heralded as having the potential for great benefits, but they also harbor the possibility of potentially tragic and even catastrophic unforeseen consequences.

The mRNA vaccines against SARS-CoV-2 have been implemented with great fanfare, but there are many aspects of their widespread utilization that merit concern. We have reviewed some, but not all, of those concerns here, and we want to emphasize that these concerns are potentially serious and might not be evident for years or even transgenerationally.

In order to adequately rule out the adverse potentialities described in this paper, we recommend, at a minimum, that the following research and surveillance practices be adopted:

•A national effort to collect detailed data on adverse events associated with the mRNA vaccines with abundant funding allocation, tracked well beyond the first couple of weeks after vaccination.

•Repeated autoantibody testing of the vaccine-recipient population. The autoantibodies tested could be standardized and should be based upon previously documented antibodies and autoantibodies potentially elicited by the spike protein. These include autoantibodies against phospholipids, collagen, actin, thyroperoxidase (TPO), myelin basic protein, tissue transglutaminase, and perhaps others.

•Immunological profiling related to cytokine balance and related biological effects. Tests should include, at a minimum, IL-6, INF-α, D-dimer, fibrinogen, and C-reactive protein.

•Studies comparing populations who were vaccinated with the mRNA vaccines and those who were not to confirm the expected decreased infection rate and milder symptoms of the vaccinated group, while at the same time comparing the rates of various autoimmune diseases and prion diseases in the same two populations.

•Studies to assess whether it is possible for an unvaccinated person to acquire vaccine-specific forms of the spike proteins from a vaccinated person in close proximity.

•In vitro studies to assess whether the mRNA nanoparticles can be taken up by sperm and converted into cDNA plasmids.

•Animal studies to determine whether vaccination shortly before conception can result in offspring carrying spike-protein-encoding plasmids in their tissues, possibly integrated into their genome.

•In vitro studies aimed to better understand the toxicity of the spike protein to the brain, heart, testes, etc.

Public policy around mass vaccination has generally proceeded on the assumption that the risk/benefit ratio for the novel mRNA vaccines is a “slam dunk.” With the massive vaccination campaign well under way in response to the declared international emergency of COVID-19, we have rushed into vaccine experiments on a world-wide scale. At the very least, we should take advantage of the data that are available from these experiments to learn more about this new and previously untested technology. And, in the future, we urge governments to proceed with more caution in the face of new biotechnologies.

Finally, as an obvious but tragically ignored suggestion, the government should also be encouraging the population to take safe and affordable steps to boost their immune systems naturally, such as getting out in the sunlight to raise vitamin D levels (Ali, 2020), and eating mainly organic whole foods rather than chemical-laden processed foods (Rico-Campà et al., 2019). Also, eating foods that are good sources of vitamin A, vitamin C and vitamin K2 should be encouraged, as deficiencies in these vitamins are linked to bad outcomes from COVID-19 (Goddek, 2020; Sarohan, 2020).

Acknowledgements

This research was funded in part by Quanta Computers, Inc., Taiwan, under the auspices of the Qmulus project.Competing interests

The authors have no competing interests or conflicts to declare.

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by Silviu “Silview” Costinescu

One of world’s most celebrated scientists (by the establishment) suggested that genetic engineering is likely to create a new species of virus or superhuman creature that could destroy the rest of humanity.

Video by Bright Side


Hawking left a collection of articles and essays on what he called “the big questions”. In Brief Answers to the Big Questions he suggests that wealthy people will soon be able to choose to edit their own and their children’s DNA to create superhumans with enhanced memory, disease resistance, intelligence and longevity. – The Times

Speaking to the Radio Times ahead of the BBC Reith Lecture in 2016, Hawking said most of the threats humans now face come from advances in science and technology, such as nuclear weapons and genetically engineered viruses.
“We are not going to stop making progress, or reverse it, so we must recognise the dangers and control them,” he added.
Speaking through his speech synthesizer at the Ri, he answered a question on whether the electronic voice had shaped his personality, perhaps allowing the introvert to become an extrovert. Replying that he had never been called an introvert before, Hawking added: “Just because I spend a lot of time thinking doesn’t mean I don’t like parties and getting into trouble.” – The Guardian


The Daily Galaxy has chosen Stephen Hawking’s contention that the human species has entered a new stage of evolution as the top story of 2009.  It was included in his Life in the Universe lecture, along with many other thought provoking observations about the human condition. 


A living being usually has two elements: a set of instructions that tell the system how to sustain and reproduce itself, and a mechanism to carry out the instructions. In biology, these two parts are called genes and metabolism. But it is worth emphasising that there need be nothing biological about them. For example, a computer virus is a program that will make copies of itself in the memory of a computer, and will transfer itself to other computers. Thus it fits the definition of a living system, that I have given. Like a biological virus, it is a rather degenerate form, because it contains only instructions or genes, and doesn’t have any metabolism of its own. Instead, it reprograms the metabolism of the host computer, or cell. Some people have questioned whether viruses should count as life, because they are parasites, and can not exist independently of their hosts. But then most forms of life, ourselves included, are parasites, in that they feed off and depend for their survival on other forms of life. I think computer viruses should count as life. Maybe it says something about human nature, that the only form of life we have created so far is purely destructive. Talk about creating life in our own image. I shall return to electronic forms of life later on. 
…
We are more than just our genes. We may be no stronger, or inherently more intelligent, than our cave man ancestors. But what distinguishes us from them, is the knowledge that we have accumulated over the last ten thousand years, and particularly, over the last three hundred. I think it is legitimate to take a broader view, and include externally transmitted information, as well as DNA, in the evolution of the human race. 
The time scale for evolution, in the external transmission period, is the time scale for accumulation of information. This used to be hundreds, or even thousands, of years. But now this time scale has shrunk to about 50 years, or less. On the other hand, the brains with which we process this information have evolved only on the Darwinian time scale, of hundreds of thousands of years. This is beginning to cause problems. In the 18th century, there was said to be a man who had read every book written. But nowadays, if you read one book a day, it would take you about 15,000 years to read through the books in a national Library. By which time, many more books would have been written. 
This has meant that no one person can be the master of more than a small corner of human knowledge. People have to specialise, in narrower and narrower fields. This is likely to be a major limitation in the future. We certainly cannot continue, for long, with the exponential rate of growth of knowledge that we have had in the last three hundred years. An even greater limitation and danger for future generations, is that we still have the instincts, and in particular, the aggressive impulses, that we had in cave man days. Aggression, in the form of subjugating or killing other men, and taking their women and food, has had definite survival advantage, up to the present time. But now it could destroy the entire human race, and much of the rest of life on Earth. A nuclear war is still the most immediate danger, but there are others, such as the release of a genetically engineered virus. Or the green house effect becoming unstable.
…
There is no time, to wait for Darwinian evolution, to make us more intelligent, and better natured. But we are now entering a new phase, of what might be called, self designed evolution, in which we will be able to change and improve our DNA. There is a project now on, to map the entire sequence of human DNA. It will cost a few billion dollars, but that is chicken feed, for a project of this importance. Once we have read the book of life, we will start writing in corrections. At first, these changes will be confined to the repair of genetic defects, like cystic fibrosis, and muscular dystrophy. These are controlled by single genes, and so are fairly easy to identify, and correct. Other qualities, such as intelligence, are probably controlled by a large number of genes. It will be much more difficult to find them, and work out the relations between them. Nevertheless, I am sure that during the next century, people will discover how to modify both intelligence, and instincts like aggression.
…
Laws will be passed against genetic engineering with humans. But some people won’t be able to resist the temptation, to improve human characteristics, such as size of memory, resistance to disease, and length of life. Once such super humans appear, there are going to be major political problems, with the unimproved humans, who won’t be able to compete. Presumably, they will die out, or become unimportant. Instead, there will be a race of self-designing beings, who are improving themselves at an ever-increasing rate.
…
If this race manages to redesign itself, to reduce or eliminate the risk of self-destruction, it will probably spread out, and colonise other planets and stars. However, long distance space travel, will be difficult for chemically based life forms, like DNA. The natural lifetime for such beings is short, compared to the travel time.
…
It might be possible to use genetic engineering, to make DNA based life survive indefinitely, or at least for a hundred thousand years. But an easier way, which is almost within our capabilities already, would be to send machines. These could be designed to last long enough for interstellar travel. When they arrived at a new star, they could land on a suitable planet, and mine material to produce more machines, which could be sent on to yet more stars. These machines would be a new form of life, based on mechanical and electronic components, rather than macromolecules. They could eventually replace DNA based life, just as DNA may have replaced an earlier form of life.

Stephen Hawking – Life in the Universe

DNA and understanding – BBC 2009

Professor Hawking, of the Department of Applied Mathematics and Theoretical Physics at Cambridge, gave a typically wide-ranging talk.

The professor said he did not advocate the genetic redesign of human beings, but saw it as inevitable as scientists gained a more complete understanding of DNA.

“Many people will say that genetic engineering on humans should be banned, but I rather doubt if they will be able to prevent it,” he said.

“Genetic engineering on plants and animals will be allowed for economic reasons and someone is bound to try it on humans.”

He said that it was unlikely to occur in the next 100 years, but GM humans would arrive sometime in the next millennium and they would bear little resemblance to the people of today.

Professor Hawking added that the only way he could see such a situation being prevented was in the event of a “totalitarian world order”.

Stephen Hawking explains Dara O’Brian why people can’t travel in space without genetic engineering

Stephen Hawking feared gene-edited superhumans would kill us all

By Nick Whigham

October 15, 2018 | 1:09pm | New York Post

The late Stephen Hawking believed advances in genetic science would lead to a future generation of superhumans who could ultimately destroy the rest of humanity.

In newly published writings, Hawking suggested an elite class of physically and intellectually powerful humans could arise from rich people choosing to edit their DNA and manipulating their children’s genetic makeup.

“I am sure that during this century, people will discover how to modify both intelligence and instincts such as aggression,” he wrote.

“Laws will probably be passed against genetic engineering with humans. But some people won’t be able to resist the temptation to improve human characteristics, such as memory, resistance to disease and length of life.”

The renowned theoretical physicist, who died in March, made the grim prediction in a collection of essays and articles recently published by the UK’s Sunday Times, prior to the release of a book containing a collection of writings by Hawking.

Those without the means to genetically modify themselves will become relegated to a sub-class of “unimproved humans,” he suggests in “Brief Answers To The Big Questions” due out on Tuesday. The wealthy who have power and access could tweak their genome to boost strength, memory and disease resistance.

Stephen Hawking

This two-tier system of humans, Hawking predicted, could have grave social consequences.

“Once such superhumans appear, there will be significant political problems with unimproved humans, who won’t be able to compete,” he wrote. “Presumably, they will die out, or become unimportant. Instead, there will be a race of self-designing beings who are improving at an ever-increasing rate.”

“If the human race manages to redesign itself, it will probably spread out and colonize other planets and stars.”

While the rise of superhumans won’t happen in our lifetime, new gene-editing technology has already led to concerns about the potential of designer babies.

Most notably, CRISPR-Cas 9 is a recently emerged technology that can be thought of as acting like a tiny pair of molecular scissors that can cut and alter nucleotides that make up DNA, enabling scientists to find and modify, or replace, genetic defects. – NY Post

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