by <a href="https://americasfrontlinedoctors.org/2frontlinenews/endless-symptoms-flowing-to-us-every-hour/">Dr. Yaffa Shir-Raz </a>

<a href="https://www.covil.co.il/en/this-is-how-pfizer-managed-to-obtain-the-fdas-emergency-authorization-for-children/">Analysis and comparison</a> of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings,  including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.
<h3> Violation of protocol conditions - How did children with a psychiatric diagnosis get to be included in the study?</h3>
According to the review document submitted by Pfizer to the FDA, four of the 1,131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events ("SAEs") - that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect.

Of these four children, three had such severe depression that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).

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The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.

To reassure us, Pfizer notes in its review document that in fact, all three children had a pre-existing diagnosis of anxiety and depression. Moreover, they explain - all three actually reported a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination.

"Worsening suicidal ideas with initial SSRI treatment in adolescents", they explain, "is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients". So here you go - why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?
<h6>What is the problem with this explanation?</h6>
<h6>Two problems:
</h6>
<ol>
 <li>The claim that the SSRIs the children received is an alternative explanation for the deterioration of the children's mental state is doubtful. According to the scientific literature, exacerbation of suicide and mental state occurs right at the beginning of treatment with antidepressants, usually in the first two weeks, and certainly not more than a month after starting treatment - which is the time when you start to see improvement. In fact, the opposite is true: if there is no improvement within four weeks, a medication is usually replaced.</li>
 <li> More importantly, according to the study protocol – participants with a previous psychiatric diagnosis should never have been included in the study in the first place (see page 41 in the protocol).
It turns out that one of the exclusion criteria in the study is: "Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study“.</li>
</ol>
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This is therefore a blatant violation of the study protocol established by the company itself and approved by the FDA. The implication of such a violation is severe: if Pfizer were so negligent that they included subjects with a psychiatric background in the experiment - contrary to the protocol they themselves established - it means that the subjects' well-being is not their main concern. As Pfizer itself notes in the protocol: such a background may increase the risk of study participation. And if they do not adhere to ethics in recruiting subjects, who can assure us that they adhere to ethics in other sections of the study - for example, analysis of results?
<h3> Designing the protocol in a way that will allow the company to present positive findings regarding the safety of the vaccine</h3>
In at least two criteria, the company appears to have manipulatively designed the protocol in a way that would allow it to present as positive findings as possible in terms of vaccine safety in children:
<ol>
 <li>Designing the protocol in a way that will reduce, as much as possible, the inclusion of severe adverse events in a report submitted to the FDA.</li>
</ol>
In the Pediatric Study Protocol (see table on page 12), Pfizer undertook that the duration of follow-up for serious adverse events (SAEs) would be "from Dose 1 to 6 months after the second dose”.

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A six-month follow-up period is considered to be very short compared to the usual follow-up time in Phase 3 studies for vaccines. According to the FDA, Phase 3 in vaccine studies should last between one and four years (4).

Yet it turns out from Pfizer's review document that the company did not complete even this relatively short follow-up period, and in fact was content with only 30 days of follow-up of the severe adverse events. This fact emerges from the chapter dealing with the date of analysis (page 30, under the heading of the SAEs chapter): "12-15-year-olds: SAEs from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of BNT162b2 recipients and 0.1% of placebo recipients“.

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<h4>How has this been made possible?</h4>
On page 114 of the study protocol - in the chapter dealing with the timing at which the statistical analyzes will be performed, Pfizer set a number of time points for the purpose of performing these analyzes. While the maximum time period for monitoring severe adverse events in the general study population is six months (the seventh section), the fifth section set an additional cut-off point, of only 30 days after the second dose for the purpose of comparing data between two age groups - one of ages 12-15 and one  of ages 16-25.

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In other words, the protocol appears to be designed in such a way that the review submitted to the FDA will only include the serious adverse events that appeared during the first month after vaccination.

Indeed the follow-up of the serious adverse events continues for another five months, but any adverse event that will be discovered during these months, or an adverse event that was observed during the first month but was defined as non-serious and has been worsening during the following months (or the diagnosis will change) - will simply not appear in the review report.

The concerning implication of this practice is that serious adverse events may not appear in the report on the basis of which the FDA issues the emergency authorization for children, so continued follow-up, even if published a few months or years after the temporary authorization was issued, will not help children who will be harmed or die following the FDA's green light. 
<h3> Designing the protocol so that diagnoses of serious adverse events given in hospitals unrelated to the study site can be ignored.</h3>
Within the terms of the Outcome Measures in the study protocol, as it is presented in <a href="http://Clinicaltrials.gov">Clinicaltrials.gov</a> Pfizer determined that the research team selected by Pfizer will be the ones defining the adverse events as such: "As elicited by investigative site staff".

This way, the company has in effect given researchers selected by them the power to define for themselves what the diagnosis will be, regardless of the diagnosis given at the hospital/ward which is not defined as the research site.

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<h4>Why is this problematic?</h4>
Because such a determination means that if a particular participant suffers from serious adverse events and has been treated, for example, outside the hospital or ward that functions as the research site, then in fact, the diagnosis made by the attending physicians at the hospital/ward in which the participant is treated is irrelevant.

This way, Pfizer has actually allowed its team to define what the diagnosis will be, rather than letting the diagnosis given by the attending physicians confuse them.
<h4>Beyond the severe criticism towards Pfizer, the analysis and comparison raise serious questions for the FDA itself:</h4>
<ul>
 <li>How is it possible that the FDA has even approved a protocol that allows such manipulations?</li>
 <li>Why did the FDA allow the company to perform the data analysis and submit the application for the emergency permit in children after such a short follow-up time of only 30 days?</li>
 <li>What made the FDA so eager to approve the emergency permit for children? Why is this approval given based on a safety report that is not even "cooked" half way? After all, there is no emergency situation for children.</li>
 <li>Why did the FDA not address these manipulations and violations of the protocol after the company submitted its review?</li>
</ul>
<a href="https://americasfrontlinedoctors.org/2frontlinenews/endless-symptoms-flowing-to-us-every-hour/">Yaffa Shir-Raz</a>, PhD, is a risk-communication researcher and a teaching fellow in the University of Haifa and the Interdisciplinary Center Herzliya in Israel.
<h6>References: </h6>
<ol>
 <li>Pfizer-BioNTech. (2021). Emergency Use Authorization (EUA) Amendment for an Unapproved Product Review Memorandum. <a href="https://www.fda.gov/media/148542/download">https://www.fda.gov/media/148542/download</a></li>
 <li>(2021). A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS<a href="https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf">https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf</a></li>
 <li>(2021). Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. <a href="https://clinicaltrials.gov/ct2/show/NCT04368728">https://clinicaltrials.gov/ct2/show/NCT04368728</a></li>
 <li>(2018). Step 3: Clinical Research<a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">https://www.fda.gov/patients/drug-development-process/step-3-clinical-research</a></li>
</ol>
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'Serious violations and manipulations of trial protocol': How Pfizer obtained FDA emergency authorization for children

Safe and effective strikes againAccording to many studies and surveys, over 15 percent of people in modern America suffer periods of depression at least once a year, and many, if not most, take prescription drugs of some form to deal with their emotions. Since mental health services are often <a href="https://www.cdc.gov/nchs/covid19/pulse/mental-health-care.htm" target="_blank" rel="noopener noreferrer">difficult to access</a>, as well as expensive, unhealthy use of illicit drugs or alcohol is also common among the depressed.Another approach has been <a href="https://www.statnews.com/2024/04/08/time-is-right-for-over-the-counter-antidepressants/?utm_campaign=pharmalot&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8Xs0nnL7hvSJsSA_go0VKTrwg5g1WD-3UaMxPPiHqSzUA4UiDBBMJIHToSFTM7DOIKFJqZ_ZJFA_fEjnCdtfbQ20iS4UFN7OOhieSR9pgHphbjJII&amp;_hsmi=301755960&amp;utm_content=301755960&amp;utm_source=hs_email" target="_blank" rel="noopener noreferrer">proposed </a>by Roy Perlis, a professor of psychiatry at Harvard Medical School and associate chief for research in the Department of Psychiatry at Massachusetts General Hospital in Boston. Noting that oral contraceptives are now available over-the-counter without a prescription, he suggests that the same should apply for the class of anti-depressant drugs known as SSRIs. After all, he claims, they are “safe and effective”:<blockquote>These medications, which have been used in the U.S. for three decades, have repeatedly been shown to be safe and effective for treating major depression and anxiety disorders.</blockquote>&nbsp;Downplaying suicide risk, homicide risk unmentionedAfter making that categorical statement on safety and effectiveness, Perlis admits that “depression is associated with increased risk for suicide and medication overdose is among the most common methods of suicide.” He claims, however, that the increased suicide risk associated with SSRIs only applies to those under the age of 25 and then only “modestly,” and that for those above this age, there is no increased risk.Based on a wealth of data, Professor Peter Gotzsche, one of the founders of the Cochrane Collaboration, concludes that <a href="https://www.madinamerica.com/2024/04/prescription-drugs-are-the-leading-cause-of-death/" target="_blank" rel="noopener noreferrer">SSRIs are far more dangerous</a> than Prof. Perlis asserts. Aside from their links to suicide (and also <a href="https://www.bmj.com/content/358/bmj.j3697/rr-4" target="_blank" rel="noopener noreferrer">homicide</a>) which apply to those over the age of 25 as well, SSRIs are also linked to events that few people would consider as being associated, such as falls in the elderly (which often contribute to death), as anti-depressants cause orthostatic hypertension, confusion, and dizziness. Given that the link is indirect, studies that investigate the dangers of SSRIs will usually miss such risks.SSRIs are also linked to <a href="https://frontline.news/post/study-depression-in-an-expectant-mother-doesn-t-harm-her-baby-anti-depressants-do" target="_blank" rel="noopener noreferrer">dangers</a> for unborn babies, and while this also applies to many OTC drugs making SSRIs so readily available may contribute to a perception that they are safe for pregnant women.Anti-depressants linked to antibiotic resistanceAn interesting <a href="https://pubmed.ncbi.nlm.nih.gov/36689653/" target="_blank" rel="noopener noreferrer">study</a> published in 2023 has also linked use of anti-depressants to antibiotic resistance, a growing and under-publicized problem across the world, providing another reason to restrict access to these drugs. The study's authors note that,<blockquote>Antidepressants are consumed in large quantities, with a similar pharmaceutical market share (4.8%) to antibiotics (5%). While antibiotics are acknowledged as the major driver of increasing antibiotic resistance, little attention is paid to the contribution of antidepressants in this process.</blockquote>&nbsp;Meanwhile, the idea of freely available ketamine sparks alarmNot too long ago, Elon Musk sparked controversy when he spoke about his use of ketamine to treat depression.<div class="raw-html-embed"><blockquote class="twitter-tweet">Depression is overdiagnosed in the US, but for some people it really is a brain chemistry issue. But zombifying people with SSRIs for sure happens way too much. From what I’ve seen with friends, ketamine taken occasionally is a better option.— Elon Musk (@elonmusk) <a href="https://twitter.com/elonmusk/status/1673567124768317440?ref_src=twsrc%5Etfw">June 27, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>Interestingly, many doctors were quick to condemn ketamine and claim that SSRIs are safer. According to <a href="https://www.sciencemediacentre.org/expert-reaction-to-comments-by-elon-musk-about-use-of-ketamine-for-depression/" target="_blank" rel="noopener noreferrer">Dr. R. McShane</a>, associate professor at the Department of Psychiatry at the University of Oxford,&nbsp;<blockquote>Using ketamine as the first alternative instead of an SSRI is not something I would recommend … The risks of long term ketamine include tolerance, which depends on the dose and how frequently it is taken. The risks of long term SSRIs are better understood.</blockquote>Dr. McShane added that,&nbsp;<blockquote>People who try to treat themselves without medical help tend to take more ketamine (ie higher doses and more frequently) than if they were being prescribed it medically.</blockquote>Presumably, this argument could be extended to any OTC medication, including SSRIs if they become OTC.&nbsp;Just waiting for a brave Pharma company to step upProf. Perlis concludes his article with the hope that,&nbsp;<blockquote>… an SSRI manufacturer [will emerge] with the courage to engage with the FDA and invest the necessary resources for a prescription-to-OTC switch, a well-trod path…</blockquote>Clearly, he is convinced that SSRIs fulfill the FDA's <a href="https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches" target="_blank" rel="noopener noreferrer">criteria </a>for OTC drugs: they can be used for self-diagnosed conditions; there is no need for a doctor's involvement to ensure safe usage; and there is only a “low” potential that the drugs will be misused or abused.For other <a href="https://www.mdedge.com/psychiatry/article/105092/depression/should-ssris-be-sold-over-counter" target="_blank" rel="noopener noreferrer">psychiatrists</a> (and many laypeople), the idea remains “unthinkable.”<blockquote>These medications, after all, carry a black box warning…</blockquote>

depressed.jpg

Psychiatric Drug

Why not? After all, they are 'proven' safe and effective...

OTC anti-depressants? Harvard Medical School professor says yes

<h2>Understanding synthetic biology (synbio)</h2><h3>What it is</h3>We've been hearing a lot about synthetic biology in terms of synthetic foods, yet synbio is more than just an attempt to recreate food, which Frontline News has <a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">written</a> about in relationship to synthetic “milk.” Synbio genetic engineers are also interested in reproducing biological organisms and creating new biological products not found in nature. Following are a few definitions of synbio to show what it encompasses:<a href="https://en.wikipedia.org/wiki/Synthetic_biology" target="_blank" rel="noopener noreferrer">Wikipedia</a> - making new biological products or redesigning existing ones:<blockquote>Synthetic biology is a multidisciplinary field of science that focuses on living systems and organisms, and it applies engineering principles to develop new biological parts, devices, and systems or to redesign existing systems found in nature. -&nbsp;</blockquote><a href="https://www.newhope.com/industry-insights/synthetic-biology-test-could-force-the-natural-products-industry-to-define-its-position" target="_blank" rel="noopener noreferrer">New Hope Network</a> - using fermentation as mini-factories to recreate natural products:<blockquote>Ultimately, synbio is an attempt to re-create something that occurs in nature by using microorganisms to act as mini-factories,” explains Dana Perls, food and technology program manager at Friends of the Earth.&nbsp;</blockquote><a href="https://www.genome.gov/about-genomics/policy-issues/Synthetic-Biology" target="_blank" rel="noopener noreferrer">Genome.gov</a> - redesigning organisms for new purposes and recreating substances in nature through artificial means:<blockquote>Synthetic biology is a field of science that involves redesigning organisms for useful purposes by engineering them to have new abilities. Synthetic biology researchers and companies around the world are harnessing the power of nature to solve problems in medicine, manufacturing and agriculture.Redesigning organisms so that they produce a substance, such as a medicine or fuel, or gain a new ability, such as sensing something in the environment, are common goals of synthetic biology projects.&nbsp;</blockquote><a href="https://www.ecofarmingdaily.com/culture-of-disruption/" target="_blank" rel="noopener noreferrer">Jim Thomas, in an interview with Eco Farming Daily</a> - treating biology as a computer program (Jim Thomas is a technology historian and long-time critic of the biotech industry):<blockquote>The core assumptions of synthetic biology are that life is a sort of computer program, that DNA is like a code and that a cell or living organism is like a computer or a machine. As long as you can “reprogram” the DNA — the instructions — then you can engineer the machine to do whatever you want it to do.&nbsp;</blockquote><h3>Products created using synthetic biology</h3><a href="https://www.newhope.com/industry-insights/synthetic-biology-test-could-force-the-natural-products-industry-to-define-its-position" target="_blank" rel="noopener noreferrer">New Hope Network</a> author Melaina Juntti said that many synbio products are already in many foods and are finding their way into dietary supplement supply chains, also. She referred to the Non-GMO Project's director of marketing and communications, Hans Eisenbeis, who said that some synbio products have already been commercialized or are in development such as “vanillin and other flavorings, several colorants, CBD, collagen, plant-based proteins, dairy proteins, vitamins, omegas, probiotics and dairy milk proteins.”&nbsp;In addition to Eisenbeis's list, Health Research Institute–HRI Labs chairman and chief scientist, John Fagan, Ph.D., added “astaxanthin, resveratrol, and squalene to the growing list.”<a href="https://www.nature.com/articles/s41467-020-20122-2" target="_blank" rel="noopener noreferrer">Nature</a> provides this list of synbio&nbsp;generated products:<ul><li>Hemme used to make the “blood” for the Impossible Burger: “The yeast Pichia pastoris was engineered to produce soy leghemoglobin, which improves meaty flavors and aromas when added to a plant-based burger.”</li><li>Other synbio products created by fermenting yeast include Vitamin E, stevia, and milk whey. Plant pathways to pharmaceuticals include taxadiene (Taxol precursor), steroids, THC, and opiates. “An early landmark achievement to make the anti-malarial Artimisin was taken into production by Sanofi, but was discontinued because the cost was higher than sourcing it from the plant.”</li><li>Januvia (sitgaliptin) is a diabetes medication manufactured by Merck. “It is the 95th most-prescribed drug with ~107 prescriptions and $1.35 billion in annual sales.”</li><li>Hyaline transparent and flexible film for electronics.&nbsp;</li><li>ProveN fertilizer being applied to corn. “Pivot Bio has created the first biological fertilizer for corn based on a γ-proteobacterium (KV137) that associates with corn roots and has the necessary genes to fix nitrogen. However, the genes are off when most needed, so synthetic biology was used to turn the genes on, which guided the remodeling of the KV137 genome.”</li><li>Kymriah, a treatment for B-cell acute lymphoblastic leukemia by Novartis, is produced by genetically modifying a patient’s T cells and is deemed an “effective living therapy.” Using engineered living cells for therapeutic purposes has been considered to be the “3rd pillar of medicine.” &nbsp;Kymriah (Tisagenlecleucel) is the first of its type to receive FDA approval.</li><li>Calyno high-oleic oil from soy “is the first product from a genome-edited plant to enter the United States food supply.” Calyno manufacturer Calyxt edited the soy genome to reduce the amount of unstable linoleic acid to create an oil containing 80% oleic acid rather than 20% in unmodified oil. To do this, Calyxt inactivated two fatty acid desaturase genes that reduce the production of the unstable linoleic acid.&nbsp;</li></ul>Nature author Chris Voigt provides a futuristic look at what else might be done with synbio such as bee-copters to transport people and trees that grow into houses. Scientists are looking to create biology-derived components. Voigt says that “[t]he next decade will see more products that derive their superior performance and affordability from engineered biology.”&nbsp;<a href="https://www.genome.gov/about-genomics/policy-issues/Synthetic-Biology" target="_blank" rel="noopener noreferrer">Genome.gov</a> provides some examples of what scientists are producing with synthetic biology,:<blockquote><ul><li>Microorganisms harnessed for bioremediation to clean pollutants from our water, soil and air.</li><li>Rice modified to produce beta-carotene, a nutrient usually associated with carrots, that prevents vitamin A deficiency. Vitamin A deficiency causes blindness in 250,000 - 500,000 children every year and greatly increases a child's risk of death from infectious diseases.</li><li>Yeast engineered to produce rose oil as an eco-friendly and sustainable substitute for real roses that perfumers use to make luxury scents.</li></ul></blockquote><h2>What could go wrong?</h2>According to Thomas, original GMOs which involved moving a single gene from one organism to another consistently produced unexpected results. Synthetic biology which is more complex will certainly lead to a greater degree of unexpected results. One such scenario, he said, would involve an organism engineered to break down cellulose that gets out into the environment:<blockquote>Let’s say you have an organism engineered to break down cellulose. If it got out into the environment, there is plenty of cellulose in our houses, clothes and fields to survive on. And we don’t know how it would change with evolution or whether it would produce toxins. Those are some of the worrying scenarios.</blockquote>Thomas wasn't pulling an example out of the air, either. He recounted a previous experience with a GMO bacteria that was designed to break down cellulose, but astute researchers discovered that it would yield unwanted results and were able to halt its release before it could do damage:<blockquote>Klebsiella planticola was a bacterium genetically engineered to break down cellulose. Fortunately, a couple of researchers looking at its impacts in the soil found that it would produce an alcohol that would kill plant roots and they were able to halt the release before it happened</blockquote>Living systems have a will to live.<blockquote>In fact, a lot of the initial work in synthetic biology sought to engineer organisms to break down cellulose into alcohol for ethanol production. If instead you break down cellulose and turn it into vanilla and that gets into the soil, we don’t know if that’s a problem. And that’s assuming that it’s going to do the thing it’s expected to do. These are living systems that evolve and have a will to live.</blockquote>New Hope further quoted Dana Perls saying that we don't understand nature well enough to know that what we are doing is totally safe.&nbsp;<blockquote>&nbsp;The problem is we don’t understand enough about how nature works to do it in a way that we can be sure is safe for human health and the environment and sustainable for small farmers.Despite biotech and agribusiness’s insistence that synbio is safe and eco-friendly, nobody knows for sure whether that’s true. Unlike first-generation GMOs—primarily plants modified with DNA from another species—this new form of gene editing is totally unregulated. USDA and FDA limit their oversight of genetically engineered products to those containing foreign DNA, which synbio ingredients typically do not have. Thus, the DARK Act of 2018, which mandates labeling of “bioengineered” foods, is of little use.</blockquote>Claims of “natural” are not accurate.<blockquote>New biotech companies are trying to pull the wool over FDA and USDA by claiming to be making ‘nature-identical’ products. But these products are not natural and are far from identical—they are genetically engineered.</blockquote><h2>Consumers and food manufacturers in the dark</h2>Consumers, New Hope's Junti wrote, are mostly unaware of synbio, even those who want GMOs labeled. And, it's not just the consumers who don't know what they're buying, she says, but the “[m]any food and dietary supplement manufacturers are also unaware of the true identity of ingredients they’re purchasing.”Related articles:<ul><li><a href="https://frontline.news/post/got-milk-it-may-not-be-real">Got milk? It might not be real</a>&nbsp;</li><li><a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">Equating lab-grown meat with animal meat is 'kooky thinking' - Alliance for Natural Health</a></li><li><a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too">Lab-grown meat not slaughter-free, not climate-friendly as claimed. Can it cause cancer too?</a></li><li><a href="https://frontline.news/post/a-little-bit-of-pfizer-in-your-cheese-fake-rennet-bypassed-additive-approval-process">A little bit of Pfizer in your cheese? Fake rennet bypassed additive approval process</a></li><li><a href="https://frontline.news/post/can-t-digest-cheese-maybe-you-can-tolerate-cheese-made-with-natural-rennet-instead-of-pfizer-s-gmo-version">Can't digest cheese? Maybe you can tolerate cheese made with natural rennet instead of Pfizer's GMO version</a></li><li><a href="https://frontline.news/post/fake-milk-inferior-to-real-milk-experts-find">Fake milk inferior to real milk, experts find</a></li><li><a href="https://frontline.news/post/fake-meat-sales-plummet-amid-falling-demand">Fake meat sales plummet amid falling demand</a></li><li><a href="https://frontline.news/post/fake-meat-industry-continues-to-plunge">Fake meat industry continues to plunge</a></li><li><a href="https://frontline.news/post/italy-becomes-first-country-to-ban-fake-food">Italy becomes first country to ban fake food</a></li><li><a href="https://frontline.news/post/fakefood-another-safe-ingredient-may-pose-health-threat">#FakeFood: Another ‘safe’ ingredient may pose health threat</a></li></ul>

DNA genetic engineering.jpg

Technology

'These products are not natural and are far from identical—they are genetically engineered'

What is synthetic biology and why should you care?

<h2 style="margin-left:0px;">Faux milk gaining ground</h2>The synbio (synthetic biology) industry is developing synthetic animal proteins including <a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">lab-grown meat</a> and <a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">synbio milk</a>. In its coverage of synbio milk, Frontline News referred to a review by Su-Jit Lin of the HuffPost about Bored Cow, a company selling its synbio milk as "The first milk alternative to do it all."&nbsp;“All,” in this sense, means animal-free, vegan-friendly, nutritionally equivalent to milk, and useful in foods, cooking, and baking in the same ways as real milk, as Frontline News reported:<blockquote>Lin reported Ben Berman, co-founder, and CEO of Bored Cow, made, stating that Bored Cow was created to “replicate the taste, texture, nutrition and functionality of conventional dairy milk” and has a nutrition panel nearly identical, if not better than the generic milk he had in his fridge.&nbsp;</blockquote>Several other companies, as Frontline News highlighted, were also producing faux milk and cheese products, making the same claims as Bored Cow, that their products are good for animals, people, and the environment. &nbsp; &nbsp;<h4 style="margin-left:0px;">Reason to doubt</h4>Frontline News has previously reported on <a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too" target="_blank" rel="noopener noreferrer">claims</a> by manufacturers of lab-grown meat which didn't hold up. Similarly, <a href="https://frontline.news/post/child-slave-labor-in-producing-ev-batteries-raises-serious-questions-about-clean-green-technologies" target="_blank" rel="noopener noreferrer">claims</a> by proponents of EV cars turned out to be dubious. It was, therefore, natural to wonder about the veracity of claims made by synbio milk manufacturers.<blockquote>Considering the magnitude of the synbio dairy industry, it is important to ask if the claims made by Bored Cow and other synbio dairy manufacturers are accurate.&nbsp;</blockquote>That is the topic of this article.<h2 style="margin-left:0px;">What could possibly go wrong?</h2>Despite Lin's enthusiastic report, there are many problems associated with synbio milk.<h3 style="margin-left:0px;">Specious claims</h3>Faux milk is promoted as being the same as real milk since the “precision fermentation” process used is based on a yeast genetically modified to produce whey protein, as <a href="https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/" target="_blank" rel="noopener noreferrer">explained</a> by the Alliance for Natural Health:<blockquote>Bored Cow is made with whey protein produced through a process called “precision fermentation,” a form of synbio. This involves taking a gene for whey protein and inserting it into a GE yeast. The yeast is put into fermentation tanks with other nutrients to help it grow. At the end the GE yeast is supposed to be filtered out, leaving only the milk protein. Bored Cow takes this protein and adds vitamins, minerals, and other ingredients to mimic the taste, consistency, and nutritional content of real cow’s milk.</blockquote>As Lin reported, Ben Berman, co-founder, and CEO of Bored Cow, boasted that his company's synthetic milk is as good as cow's milk. Berman said that Bored Cow has a nutrition panel nearly identical, if not better, than the generic milk he had in his fridge. &nbsp;However, as ANH explained, it is not likely that synbio milk is equivalent to real milk, because of the complexity of real milk. Cow's milk is more than just the vitamins listed on the nutrition panel.<blockquote>[It is not] very likely that Bored Cow is nutritionally equivalent to real milk. Just as meat is more than just protein, milk is far more than a simple combination of whey and various vitamins and minerals. Milkfat contains 400 different fatty acids. Milk has two types of proteins, whey and casein—and there are several different types of these two proteins contained in milk, and a whole bundle of other compounds like lactoferrin and bioactive peptides that help prime the immune system.</blockquote><h3 style="margin-left:0px;">Nutritional dark matter - 92 unknown compounds&nbsp;</h3>When the Iowa-based Health Research Institute (HRI) tested Bored Cow's faux milk using full-spectrum molecular analysis technology, they discovered 92 compounds that are yet to be identified, and the presence of which are not noted on the nutritional panel. As Ken Rosenboro, editor for the Organic and Non-GMO Report <a href="https://non-gmoreport.com/not-so-precise-fermentation-lab-finds-92-unknown-compounds-in-synthetic-biology-milk/" target="_blank" rel="noopener noreferrer">wrote</a>, HRI's chief science officer John Fagan was concerned that they could not identify those compounds.<blockquote>Calling them completely novel to our food,” he says. “They are things that we haven’t consumed as human beings.”Fagan scanned scientific literature and databases to determine whether the molecules had nutritional or other beneficial properties and found nothing.“I couldn’t even find the scientific name for the vast majority of the molecules present in the Bored Cow product. They are nutritional dark matter,” Fagan says.Fagan speculated that the unknown molecules could either be nutrients or waste products created during the fermentation process, stating that if they are waste products you wouldn't “necessarily want them in your food.”</blockquote><h3 style="margin-left:0px;">GMO without the designation</h3>Rosenboro noted that Bored Cow and Perfect Day, the company that manufactures the whey protein Bored Cow uses, avoid using the term genetically engineered to describe the yeast used in the production of the whey protein, preferring “microflora” instead.&nbsp;<blockquote>Bored Cow and Perfect Day use the term “microflora” to avoid using “genetically engineered” or “GMO.”&nbsp;</blockquote><h3 style="margin-left:0px;">Not cow protein&nbsp;</h3>As if the 92 unidentifiable compounds were not enough of a problem, HRI also found that the fake milk's protein, assumed to be cow protein, was mostly from the GMO yeast and not the milk protein.&nbsp;<blockquote>Perfect Day and Bored Cow both claim the milk protein is identical to the protein in cow’s milk but HRI’s tests found that the protein in Bored Cow’s milk was mostly from the GMO yeast and not the milk protein.</blockquote>The amino acids in the product were also different from those in real milk.<blockquote>“The amino acid composition of the protein that’s present in the Bored Cow milk is strikingly different from the amino acid composition of real milk,” Fagan says. “We have data that shows this is the case.”</blockquote><h3 style="margin-left:0px;">Have some GMO DNA with your Bored Cow</h3>Fagan said that the GMO-derived microflora or yeast, which was supposed to have been removed during fermentation, was still found in the final product, Rosenboro also reported:<blockquote>“The (genetically engineered) DNA in these products is broken up or fragmented but is certainly still there,” Fagan says.Further he says tests are being developed to detect the GMO DNA in synthetic biology products like Bored Cow.</blockquote>GMO DNA in synbio products would have to be labeled as such under the bioengineered food disclosure law.<blockquote>“The reality is that all that’s required is to do a little bit of molecular biology and a GMO test can be developed for synbio products,” says Fagan who pioneered creating laboratory tests for GMO corn and soybeans when they were first commercialized in the late 1990s.The presence of GMO DNA in Bored Cow and other synbio products would mean that they would have to be labeled under the U.S. Department of Agriculture’s National Bioengineered Food Disclosure law. Right now, such products don’t require labeling.</blockquote><h3 style="margin-left:0px;">No safety assessments</h3>Rosenboro explained that the FDA does not require safety assessments for synbio milk. That milk, however, with its 92 unknown compounds, would have to undergo testing in Europe and Canada as a novel food.&nbsp;ANH <a href="https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/" target="_blank" rel="noopener noreferrer">elaborated</a> on the lack of safety assessment, explaining that Perfect Day, the manufacturer of the synbio whey protein used by Bored Cow, like some food manufacturers, claimed on its own that its product was GRAS (generally recognized as safe), utilizing the FDA's expedited process of GRAS <a href="https://qualitysmartsolutions.com/self-affirmed-gras/" target="_blank" rel="noopener noreferrer">self-affirmation</a> which does not require FDA review.<blockquote>The FDA must be on top of this, right? Wrong. Bored Cow has not undergone safety testing at the FDA. Perfect Day, the manufacturer of the synbio whey protein, determined it was “generally recognized as safe” (GRAS) and voluntarily notified the FDA of this determination; in response the FDA said it had no questions. Given how rife the GRAS process is with conflicts of interest, this is akin to taking the company’s word for it that its novel synbio whey protein is safe.</blockquote><h3 style="margin-left:0px;">Climate-friendly? Not so fast&nbsp;</h3>Rosenboro referred to an article in Forbes by Errol Schweizer, partner of food and agriculture at Impakt, IQ, who questioned the claim that synbio is sustainable and climate-friendly. He wanted to know how the waste material would be disposed of; the amount of energy and resources used as compared to animal-based products; and the use of high-fructose corn syrup to feed the yeast as corn production is energy intensive and polluting.&nbsp;<h3 style="margin-left:0px;">Biology doesn't work like a computer program</h3>Synbio products are being likened to a computer program so all that needs to be done is to program the DNA like a computer, a flawed assumption according to Fagan. The analogy doesn't hold water, he says, since even yeast is infinitely more complicated than computer programs.<blockquote>An article in FoodNavigator USA even describes GMO yeasts being “programmed” to produce proteins. The problem is that the internal functioning of even the simplest organisms like a yeast is vastly more complex than computer programs.“It is a hollow analogy because it implies that you have the same kind of precise control in synthetic biology that you have programming a computer. It’s much more complex,” Fagan says. “Here we have an example of 92 unpredicted compounds being produced, and only a trace of the whey protein that you really want. It’s nothing like precision.” &nbsp;</blockquote>In the tweet below, Millions Against Monsanto links to a lecture by John Fagan about precision fermentation.<blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">Listen to Dr. John Fagan’s Concerning New Findings: <a href="https://t.co/FruJ15ACrz">https://t.co/FruJ15ACrz</a> "His latest research takes aim at the synthetic biology industry, also called 'precision fermentation.'" <a href="https://t.co/3ZCZdgRuWW">pic.twitter.com/3ZCZdgRuWW</a>— Millions Against Monsanto (@againstmonsanto) <a href="https://twitter.com/againstmonsanto/status/1759246872303087825?ref_src=twsrc%5Etfw">February 18, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div></blockquote>Related articles:<ul><li><a href="https://frontline.news/post/danger-ahead-changing-the-natural-world-with-genetic-engineering-and-artificial-intelligence" target="_blank" rel="noopener noreferrer">Danger ahead! Changing the natural world with genetic engineering and artificial intelligence</a></li><li><a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">Got milk? It might not be real</a></li><li><a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">Equating lab-grown meat with animal meat is 'kooky thinking' - Alliance for Natural Health</a></li><li><a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too">Lab-grown meat not slaughter-free, not climate-friendly as claimed. Can it cause cancer too?</a></li><li><a href="https://frontline.news/post/a-little-bit-of-pfizer-in-your-cheese-fake-rennet-bypassed-additive-approval-process">A little bit of Pfizer in your cheese? Fake rennet bypassed additive approval process</a></li><li><a href="https://frontline.news/post/can-t-digest-cheese-maybe-you-can-tolerate-cheese-made-with-natural-rennet-instead-of-pfizer-s-gmo-version">Can't digest cheese? Maybe you can tolerate cheese made with natural rennet instead of Pfizer's GMO version</a></li><li><a href="https://frontline.news/post/fake-milk-inferior-to-real-milk-experts-find">Fake milk inferior to real milk, experts find</a></li><li><a href="https://frontline.news/post/fake-meat-sales-plummet-amid-falling-demand">Fake meat sales plummet amid falling demand</a></li><li><a href="https://frontline.news/post/fake-meat-industry-continues-to-plunge">Fake meat industry continues to plunge</a></li><li><a href="https://frontline.news/post/italy-becomes-first-country-to-ban-fake-food">Italy becomes first country to ban fake food</a></li><li><a href="https://frontline.news/post/fakefood-another-safe-ingredient-may-pose-health-threat">#FakeFood: Another ‘safe’ ingredient may pose health threat</a></li></ul>

milk in test tubes.jpg

No FDA safety testing

'Nutritional dark matter' in Bored Cow's synbio milk - 92 unknown compounds

This Wednesday, the senior editor of NPR, Uri Berliner, announced that he would be resigning from the organization for which he has worked for the past 25 years.<div class="raw-html-embed"><blockquote class="twitter-tweet">My resignation letter to NPR CEO <a href="https://twitter.com/krmaher?ref_src=twsrc%5Etfw">@krmaher</a> <a href="https://t.co/0hafVbcZAK">pic.twitter.com/0hafVbcZAK</a>— Uri Berliner (@uberliner) <a href="https://twitter.com/uberliner/status/1780610524411048183?ref_src=twsrc%5Etfw">April 17, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>The day before he tendered his resignation, Berliner had been suspended from NPR for five days without pay, due to the criticism of his colleagues regarding a piece he wrote for The Free Press, excoriating NPR for its progressive bias.&nbsp;&nbsp;The apology as a weaponInstead of resigning, Berliner could have apologized, recanted, and moved on — as many have done before him, especially when they cannot afford to lose their source of income. The more people take this route, the harder it is to be the outlier, especially as that outlier can be ostracized not only at work but also in his entire social circle, and perhaps even among family and relatives.In an environment where backing down and repenting one's “unwoke” ideas is increasingly idolized, groupthink becomes swiftly embedded and harder to resist.According to Dr. James Lindsay, embedding groupthink is part of the plan, and the plan was hatched not in the United States but in China, where its finer points were tested on the native population before being exported in order to destabilize and weaken China's main rival on the world stage.<div class="raw-html-embed"><iframe width="681" height="383" src="https://www.youtube.com/embed/MjQp-ZLu0oI" title="James Lindsay on Struggle Sessions: Have Chinese Political Warfare Tactics Influenced American DEI?" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen=""></iframe></div>Dr. Lindsay explains that the “crimes” of the DEI age are intentionally vague.<blockquote>They're training you to recognize your crimes on a predetermined set of terms … and their goal is to pressure you psychologically into figuring out in their terms how you harmed other people.</blockquote>He notes the extensive use of the word “harm," a typically vague term that is essentially impossible to prove or refute.When a person is accused by someone in the workplace or any other setting of having “harmed” someone, he continues, what happens is that the person's social milieu is “weaponized” against them. The person comes under tremendous psychological pressure to “just apologize” and restore the good name of the company, social group, family etc.<blockquote>This is psychological torture that's effected through manipulating the social environment around you to create psychological struggle so that you recognize crimes that are ill-defined in reality…It ends with you selling yourself out.</blockquote>&nbsp;DEI or DIE?Berliner is a prominent example of what is happening in workplaces in many places around the world, where those who dare to resist the prevailing worldview of the institution (even, or perhaps especially, if said institution is supposedly practicing even-handed, <a href="https://thehill.com/opinion/campaign/3950550-the-truth-about-nprs-funding-and-its-possible-future/" target="_blank" rel="noopener noreferrer">government-sponsored</a> journalism) are aggressively weeded out.According to a recent representative <a href="https://freespeechunion.org/the-edi-tax-how-equity-diversity-and-inclusion-is-hobbling-british-businesses/?mc_cid=1c18d61fed&amp;mc_eid=33114c8522&amp;utm_source=substack&amp;utm_medium=email" target="_blank" rel="noopener noreferrer">survey</a> conducted in the U.K., training in DEI (referred to in Britain as EDIC—Equity, Diversity, Inclusion and Climate) is endemic in the British workplace. 65% of those surveyed said that they had been obliged to undergo some form of diversity training by an employer.Among those who underwent DEI training, the majority reported that they had felt compelled to hide their true opinions of the content. Over one in five said they had “said what they ought to say rather than what they thought.” Among Black and Asian respondents, this proportion rose to almost one in three. Apparently, their caution was well-founded, as 36 percent of those surveyed said that they had witnessed staff being penalized for challenging DEI training and 12 percent said they had seen staff fired.Almost half of those surveyed who went through training said that what they were forced to learn conflicted with their values, and almost a third of respondents said that they had left a job because their employer adopted “woke” ideology. Here, too, the proportion was higher among minority groups and also among those who identify as LGBT.&nbsp;The survey did not examine the reasons why those identifying as LGBT should object to woke ideas, but recent activity on the part of organizations such as <a href="https://www.theguardian.com/society/2022/sep/14/lie-of-gender-identity-spurred-founding-of-lgb-alliance-court-told" target="_blank" rel="noopener noreferrer">LGB Alliance </a>against trans-promoting groups perhaps gives a clue to where they are coming from. While woke-trans is an ideology, many who call themselves L, G, or B do not allow their form of intimate attraction to define their entire identity and object to giving it so much prominence.The report's authors concluded that DEI is operating,<blockquote>… in effect, as a tax … Many ambitious employees and senior managers are leaving companies because of the excessive time they're expected to spend on these courses … Genuine diversity of thought is required for any business to thrive, but much EDIC training is having the opposite effect and embedding a new form of groupthink.</blockquote>According to Dr. Lindsay, this is exactly the plan being implemented by influential elements who have succeeded in permeating virtually all U.S. institutions, from the armed forces to the universities, corporations to smaller businesses, government local and federal — essentially, everywhere. Whether or not the United States will be next to adopt draconian thought-police laws like those now in place in Scotland remains to be seen.

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