‍1976 Swine Flu vaccine programThis program, in hindsight, was mounted to gain support for the Presidential election of Gerald Ford, who was running against Jimmy Carter. &nbsp;The program was conceived after a soldier died at Fort Dix (after an exhausting march) and then he and several other soldiers were found to harbor swine influenza virus. The specter of the 1918 swine flu pandemic was invoked, and the public health machinery went into overdrive to create a national vaccine program. Several Pharma companies were enlisted to produce vaccines.As several months wore on, there were no more swine flu cases. &nbsp;The risk of another 1918 flu had vanished. But <a href="https://pubmed.ncbi.nlm.nih.gov/25032342/">the vaccination program had taken on a life of its own</a>.The vaccine companies demanded relief from liability. After all, it is hard to get everything right the first time. They declined to continue the vaccine program, complaining that their insurers refused to take on the liability burden. &nbsp;This became the first time the federal government agreed to serve as Pharma's insurer. &nbsp;This event became the model for the <a href="https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act">1986 National Childhood Vaccine Injury Act.</a>You know the rest of the story. &nbsp;One quarter of the US got vaccinated, before it was acknowledged that the vaccine caused paralysis. Guillain-Barre syndrome, at a rate 6 times normal, was occurring in vaccinees. &nbsp;There were about 400 cases and 40 deaths. &nbsp;Vaccinations ended. &nbsp;The virus was gone long before the vaccinations had even started, and has never returned. The federal government paid damages. Pharma and their insurers had been a lot more savvy than the U.S. public health enterprise.2003 Smallpox vaccination programThis was a program rooted in fear of bioterrorism engendered by the 2001 anthrax letters and the hype provided by the media. &nbsp;Everyone knew the nasty little phrase, "It's not a question of if, but when" and preparedness was on everyone's mind. &nbsp;There was no intelligence supporting an imminent threat of smallpox. But the vaccine program was a central part of the campaign of fear that was used to justify the invasion and takeover of Iraq. The idea fed to Americans was that we had to stop Saddam before he sprayed us with smallpox, even though he had nothing to do with either the anthrax letters, or the 9/11 attacks. The fact that the United States' American Type Culture Collection had provided Iraq's atomic energy agency with Vollum strain anthrax was kept as quiet as possible.Smallpox vaccine had been stockpiled by the Clinton administration, and more had been purchased by the Bush administration. &nbsp;Smallpox vaccinations had been halted in the US decades earlier, and the disease smallpox had been wiped out in 1977. &nbsp;Smallpox vaccine was &nbsp;known to be highly reactogenic, and the old medical literature claimed it killed one in a million babies who received it.Smallpox vaccine was also known to cause myocarditis, with EKG changes occurring in 3% of Finnish soldiers who had received the vaccine, in a <a href="https://europepmc.org/article/med/736507">1978 publication</a>. &nbsp;In the US, <a href="https://jamanetwork.com/journals/jama/fullarticle/196808">1 in 13,000 smallpox vaccine-naive airmen developed a clinical case of myopericarditis </a>after receiving their first dose.When the vaccine was given to healthcare workers and first responders in 2003, episodes of heart failure, heart attacks, myocarditis and death quickly mounted. Doctors and nurses noticed that they could not sue for damages if injured, and at first there was no federal compensation either. &nbsp;They began refusing to be vaccinated. &nbsp;Congress quickly allotted money for a compensation program, but the maximum award was only $250,000 for a permanent disability or death.Well-paid professionals were not impressed. &nbsp;After about 50,000 inoculations, and a series of <a href="https://www.nap.edu/catalog/11240/the-smallpox-vaccination-program-public-health-in-an-age-of">6 negative "Letter Reports" by the Institute of Medicine</a>, the program quickly petered out, at least for civilians. &nbsp;The military continued vaccinating soldiers. &nbsp;Yet no smallpox cases have occurred since 1977.2009 Swine Flu vaccination programIn the early spring of 2009, another swine flu was discovered in Mexico, and quickly spread to the U.S. People were said to be dying from the illness in droves. &nbsp;Not only the United States, but the entire 'developed' world clamored for vaccines. Again, the initial hype was that this was a tremendously dangerous flu bug, probably 1918 all over again.Not only were multiple new vaccines to be created, but this was also an opportunity to trial new vaccine adjuvants, which by supercharging the immune response, could cut down the amount of antigen needed by an estimated 80%, thus providing much faster production of the large volumes of vaccine needed.The 2009 "swine flu" pandemic was a dud in terms of virulence--it turned out to be considerably less deadly than a normal flu season virus. &nbsp;It did, however, serve to expose the fact that pre-existing pandemic flu vaccine deals had already been negotiated and signed by the World Health Organization, Big Pharma, and individual countries. &nbsp;Here is how the deals worked: &nbsp;once a pandemic was declared by the WHO Director-General, the contracts were activated, and countries were committed to buying large stocks of pandemic vaccine, sight unseen. &nbsp;Other agreements and memoranda of understanding guaranteed that the flu vaccines (the original concern was a deadly bird flu or swine flu pandemic) would be grandfathered in, dodging the unpredictable testing and licensure process in which many more vaccine candidates fail than finally cross the finish line.Also exposed by the 2009 pandemic was the fact that <a href="https://www.google.com/search?client=safari&rls=en&q=World+Health+Organization+changed+definition+of+a+pandemic&ie=UTF-8&oe=UTF-8">the WHO had, only a month earlier, changed its official description-definition of a pandemic's "Phase 6"</a>. &nbsp;The phrase “enormous numbers of deaths and illness” had been removed from the W.H.O. webpage listing the phases of a pandemic, and the revised web page simply read as follows: “An influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity.” &nbsp;Surprisingly, a novel virus that only caused a cold would have met the definition.A declaration of pandemic Phase 6 was the requirement that would trigger the pre-existing vaccine contracts, committing many nations to spend billions of dollars on vaccines yet to be designed.Why had WHO changed the definition? What was the process that led WHO's then-Director General &nbsp;Margaret Chan to invoke it? We still don't know.The 2009 pandemic was an opportunity that opened the door to powerful vaccine adjuvants. &nbsp;The US bought large quantities of adjuvants from GlaxoSmithKline and Novartis (which has since sold its vaccine businesses) as well as large quantities of rapidly tested vaccines. &nbsp;But in response to widespread fears about these novel adjuvants, and their potential to cause autoimmune illnesses, they were not added to the new swine flu vaccines in the US.In Europe things were different. The adjuvants were used. &nbsp;The GSK vaccine with adjuvant, Pandemrix, <a href="https://www.sciencemag.org/news/2015/07/why-pandemic-flu-shot-caused-narcolepsy">led to over 1300 cases of severe narcolepsy</a>, primarily in adolescents. &nbsp;Whether this was caused by the vaccine antigens or the adjuvant has not been resolved. &nbsp;Glaxo unsurprisingly has denied its vaccine caused the problem.However, studies of the frequency of new narcolepsy cases in many European countries revealed that adolescents who had received the Pandemrix vaccine were 10-16 times more likely to develop narcolepsy as those who had not. The 2009 pandemic revealed something else. &nbsp;The vaccine contracts that had been mediated by the WHO between the vaccine manufacturers and individual nations contained a clause absolving the manufacturers of all liability for injuries. &nbsp;In order to access vaccines, countries had to agree that their citizens could not sue the manufacturers for damages if deaths or injuries occurred. &nbsp;Litigation of some of the narcolepsy cases continues, as the UK government has flip-flopped over its responsibility to compensate those injured by the Pandemrix vaccine. --------------------Those are the prior examples of "warp speed" vaccine development for perceived pandemics. &nbsp;In no case were the vaccine manufacturers willing to take on liability for their products. &nbsp;In each case, governments took on the liability, but grudgingly. &nbsp;Any <a href="http://anthraxvaccine.blogspot.com/2020/12/what-happens-if-something-goes-wrong.html">benefits awarded were considerably less</a> than would be expected from successful litigation with pharmaceutical companies.Why won't the manufacturers stand by their products? Because there is no possible way to determine the products' safety or effectiveness in the short time allotted. The two swine flu programs went from conception to vaccinating citizens in approximately six months, similar to what was achieved with the Covid-19 vaccines. (Claims that the warp speed vaccines were the fastest ever developed is simply wrong.) The smallpox program was a little different, as vaccine had been stockpiled, but not clinically tested, over several years.How long is the usual process of vaccine development? &nbsp;According to the <a href="https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation">American College of Physicians</a>,<blockquote>Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement...Vaccines are developed, tested, and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non-vaccine drugs...</blockquote><a href="https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html">CDC says</a>, Vaccine licensing is a lengthy process that can take 10 years or longer. <h3>The Vaccine Life Cycle: Safety at Every Phase</h3><figure class="w-richtext-figure-type-image w-richtext-align-center"><div><img alt="Vaccine safety in the United States includes safety measures at every phase of vaccine development and approval, and ongoing safety monitoring once vaccines are in use." src="http://rafaelr58.sg-host.com/wp-content/uploads/2021/11/608856a84457b17ebbb23f14_Vaccine-Safety-Process.png" width="auto" height="auto" loading="auto"></div></figure>The bottom line is that given current technology, it is impossible to make a safe and effective vaccine in months. &nbsp;Everyone wishes it wasn't so, and Presidents may think they have the funds and clout to compel the system to produce a great vaccine, or six, at warp speed. They may think they can make it happen, but they can't. When you hand billions of dollars to inveterate government bureaucrats with MDs after their names, tragedies are certain to follow. &nbsp;They always have.Repurposed drugs could have won against this pandemic, and most likely the next, since we know a lot more about how to combat viruses using drugs in 2021 than ever before. &nbsp;Can someone tell the President he can be an even bigger hero using drugs instead of vaccines, since they are more readily available, cheaper and safer? I'm very concerned about the next time, given all these future vaccine contracts. &nbsp;What does the government know that I don't about the next time?---------------------Then again, when the public health bureaucracy is working so hard to get us all vaccinated, especially those who are already immune (i.e., at greater risk of serious adverse reaction, with no benefit at all from a vaccine) you just have to ask, what are they really trying to do?If you want us to have immunity passports, then check our immunity. Why can't I get an acceptable immunity test?Why do we need to get vaccine passports instead of immunity passports? &nbsp;Why has the US government and the EU committed to buying many vaccine doses per person for several years?What are they putting, or planning to put, into those injections?Or could the purpose be to put our life onto an app? Is the vaccine passport going to be the social credit score/finances/travel/privileges/ control app? &nbsp;The <a href="https://www.ft.com/content/3995af05-6bde-47f7-9f43-8eacc4600b43">Financial Times</a> suggests,<blockquote>"There is an opportunity here to use the Covid-19 pass as a building block for a digital infrastructure that could service public needs well beyond the pandemic — for example in banking, education or public health more generally..."</blockquote>‍

When mass vaccination programs are mounted in a hurry, bad outcomes and liability are invariably big issues

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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