Who are COVID shots designed for?That’s just one of many intriguing questions prompted by a perusal of the Pfizer documents currently being published in batches after a&nbsp;federal&nbsp;judge&nbsp;in&nbsp;the&nbsp;state of Texas ruled that the pharmaceutical company is obligated to release the data in a timely manner.The simple answer to our opening question is: everyone. That’s why we have been pressured and often mandated to take the shots – the powers-that-be want us all to take them. But with COVID, nothing is simple.By now, everyone must know that COVID is only dangerous for a very small tranche of the population. On average, people who die from COVID are in their late 70s to early 80s and have several serious comorbidities. Children are at virtually zero risk of dying of COVID; anyone under the age of 50 faces only a very tiny risk.Therefore, it would be reasonable to assume that vaccines against COVID were designed first and foremost for that small minority which genuinely has something to worry about – which would mean that the trial studies testing the shots before they were marketed should have focused on this small minority.That is not what happened.In the latest batch of documents released, Pfizer’s “exclusion criteria” for participation in its trials are listed.&nbsp;<a href="https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf" target="_blank" rel="noopener noreferrer">Here</a> they are. &nbsp;I'd like to focus on #29.&nbsp;<figure class="image image_resized" style="width:75%;"><img src="/uploads/pfizer_dump_exclusion_1_8b8c274015.png"></figure><figure class="image image_resized" style="width:75%;"><img src="/uploads/pfizer_dump_exclusion_2_fa8d03be62.png"></figure><figure class="image image_resized" style="width:75%;"><img src="/uploads/pfizer_dump_exclusion_3_7051e52524.png"></figure><figure class="image image_resized" style="width:75%;"><img src="/uploads/pfizer_dump_exclusion_4_2812f75e55.png"></figure><figure class="image image_resized" style="width:75%;"><img src="/uploads/pfizer_dump_exclusion_5_bfe90778a9.png"></figure>29. For older adults only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors:-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Hypertension-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Diabetes mellitus-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Chronic obstructive pulmonary disease-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Asthma-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Chronic liver disease-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; … chronic kidney disease…-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Serious heart conditions…-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Cancer-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Are immune compromised…-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Resident in a long-term facility…&nbsp;That’s quite a comprehensive list even aside from the other 28 categories excluded. It also includes virtually everyone at high risk of dying of COVID, as we know now, and as Pfizer and others “in the know” had good reason to suspect then, with plenty of evidence to rely on. (Incidentally, asthma is no longer considered a risk factor, but Pfizer was playing it safe.)Playing it safe?Safe for whom?Didn’t they want to know if their shots were a) effective and b) safe for those who were theoretically most in need of them?Didn’t the FDA want to know?

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Medical

Pfizer

All high risk groups were excluded from the trial studies. Why?

The Pfizer Files: This month's revelations

If we ignore them, will they go away?On April 13, 2024, tens of thousands of Japanese participated in rallies against the proposed WHO (World Health Organization) Pandemic Treaty. Mainstream media outlets ignored the rallies.<div class="raw-html-embed"><blockquote class="twitter-tweet" data-media-max-width="560">Japan A massive protest in Japan against the WHO pandemic treaty. More and more people are standing up against a horrendously illiberal unelected authoritarianism that is wilfully bypassing any public vote or democracy. <a href="https://t.co/2WYZt2K5PS">pic.twitter.com/2WYZt2K5PS</a>— James Melville (@JamesMelville) <a href="https://twitter.com/JamesMelville/status/1779181844199547299?ref_src=twsrc%5Etfw">April 13, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>Organizers hoped over a hundred thousand people would participate, and according to some accounts, at least that number of people attended the various rallies held. They were protesting not only the proposed loss of sovereignty entailed in accepting the WHO's terms, but also the aftermath of the COVID fiasco, and specifically, the injuries of those coerced into taking the shots.&nbsp;‘An extreme violation of human rights’Many demonstrators called for accountability and a proper investigation into excess deaths, which have mounted steadily in Japan as in most if not all other countries where “vaccine” mandates were put in place.&nbsp;One speaker, the eminent Professor Masayasu Inoue, called for people to resist the introduction of genetic “vaccines” into their bodies, a call he has issued a number of times in the past, including in the video below which has already been viewed by millions.<div class="raw-html-embed"><iframe width="543" height="383" src="https://www.youtube.com/embed/MOm5X7NoDDg" title="Stunning Message For the World from Japan from Professor Masayasu Inoue." frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen=""></iframe></div>In his video address, the professor accused the WHO of using the “pandemic” as a “false pretext … to drive vaccinations of all peoples in the world.” He added that,<blockquote>I believe that the fraudulent use of experimental gene therapy to healthy people, particularly to healthy children, is an extreme violation of human rights.&nbsp;</blockquote>He also discussed Japan's involvement in preparations for Disease X, including a super-warp-speed program to develop new “vaccines" within 100 days, and said that,<blockquote>This is possible only by ignoring the human rights perspective. Amendments to the WHO, International Health Regulation (IHR), and the so called Pandemic Treaty … are attempting to give rationality and legal binding force to such unscientific and dangerous crazy plans … [and this] would leave irreparable harm to future generations. Therefore, the actions of Japanese government MUST BE STOPPED by international collaborations.</blockquote>&nbsp;Hands up for global feudalismOpposition to the WHO's plans is mounting across the world. A group calling itself the Pan-African Epidemic and Pandemic Working Group recently issued a <a href="https://www.scidev.net/global/news/african-scientists-slam-unequal-pandemic-treaty/" target="_blank" rel="noopener noreferrer">statement </a>against the proposals, saying that they would,<blockquote>lead to the disruption of economies and education, entrenching future poverty and multi-generational inequality, and expanding national debt directly correlated to the debt crisis in Africa today…</blockquote>In <a href="https://www.westernstandard.news/news/louisiana-senate-passes-bill-to-ban-all-woke-organizations-decrees-cpc-mp-proposes-canada-follow-suit/53416" target="_blank" rel="noopener noreferrer">Louisiana</a>, the state legislature has passed a law barring the WHO and other global-reach organizations from infringing on their rights; clause 24 of the new law states that:<blockquote>The World Health Organization, United Nations, and the World Economic Forum shall have no jurisdiction or power within the state of Louisiana. No rule, regulation, fee, tax, policy, or mandate of any kind of the World Health Organization, United Nations, and the World Economic Forum shall be enforced or implemented by the state of Louisiana or any agency, department, board, commission, political subdivision, governmental entity of the state, parish, municipality, or any other political entity.</blockquote>&nbsp;We the people want to rule ourselvesRallies are also scheduled to take place in New York and Geneva next month, in advance of voting on the WHO's proposals. In New York, the rally will be held on May 25th outside the UN Headquarters on E. 47th Street at 12 PM. In Geneva, the rally is being organized by <a href="https://www.thegenevaproject.org/" target="_blank" rel="noopener noreferrer">The Geneva Project</a>:<blockquote>The Geneva Project is the start of the global movement of unity. We, The People Of the World, will no longer tolerate being ruled by unelected global officials. The time has come to break free from the chains that restrain us, and begin to create a society that serves the people…The Geneva Project is a reawakening of the strength that the 8 billion citizens of the world have held all along.</blockquote>Related Articles:<ol><li><a href="https://frontline.news/post/biden-may-bypass-senate-for-who-power-transfer">Biden may bypass Senate for WHO power transfer</a></li><li><a href="https://frontline.news/post/senators-oppose-transfering-pandemic-powers-to-who">Senators oppose Biden transferring pandemic powers to WHO</a></li><li><a href="https://frontline.news/post/46-senators-now-support-bill-requiring-senate-approval-for-who-pandemic-treaty">46 senators now support bill requiring senate approval for WHO pandemic 'treaty'</a></li><li><a href="https://frontline.news/post/australian-parliamentarian-attacks-who-for-keeping-83-rapists-on-staff-all-answering-to-terrorist-chief">Australian Senator attacks WHO for keeping 83 rapists and molesters on staff, all answering to terrorist chief</a></li><li><a href="https://frontline.news/post/senate-rejects-requirement-it-ratify-who-pandemic-treatyd">Senate won't force Biden to bring WHO Pandemic Treaty to vote</a></li></ol>

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NYC rally against Pandemic Treaty in May

MSM blackout on massive rallies in Japan against WHO and super-warp-speed 100-day vaccines

<h2>Faux meat, meet faux dairy</h2>You may not have heard as much about synbio (synthetic biology) milk as about lab-grown meat, which Frontline News recently <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">brought</a> to readers' attention. Lab-grown meat is produced by replicating cells from a cow. Synbio dairy is produced by “precision fermentation,” a process that uses genetically engineered yeast to replicate a whey protein. The Alliance for Natural Health (ANH) <a href="https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/" target="_blank" rel="noopener noreferrer">describes</a> how the Bored Cow company uses precision fermentation to make its synbio milk.<blockquote>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><a href="https://www.nongmoproject.org/blog/new-gmo-alert-animal-free-dairy-products-to-watch-out-for/" target="_blank" rel="noopener noreferrer">According</a> to the Non-GMO Project Standard, all products of genetic engineering, including synthetic biology, are GMOs.Bored Cow's synbio milk is <a href="https://tryboredcow.com/" target="_blank" rel="noopener noreferrer">sold</a> in stores such as Sprouts Market, Fairway, Save Mart, and others. It advertises its genetically engineered faux milk as "The first milk alternative to do it all."&nbsp;Does it really “do it all?” For people interested in fake foods, synbio milk certainly seems to fit the bill; it's animal-free, vegan-friendly, said to be nutritionally equivalent to milk, and can be used in foods, cooking, and baking in the same ways as real milk. In her article about Bored Cow for HuffPost, Su-Jit Lin <a href="https://www.huffpost.com/entry/bored-cow-dairy-milk-no-animal_l_646292d2e4b018d846bf9f1f" target="_blank" rel="noopener noreferrer">sings</a> the faux milk's praises.&nbsp;<h3>Animal free&nbsp;</h3>Lin explains that the milk-like product does not involve any animals because the genetic sequencing of the Montana cow named Dominette used to make it was already on file with the Bovine Genome Project. Because no animals were involved, the company claims it is vegan-friendly, although unsafe for those with milk allergies.<h3>Better than the real thing?</h3>Ben Berman, co-founder and CEO of Bored Cow, stated that their product, created to “replicate the taste, texture, nutrition and functionality of conventional dairy milk,” has a nutrition panel nearly identical to, if not better than, the generic milk he had in his fridge, according to the report:&nbsp;<blockquote>Like other milk alternatives, we combine our protein with plant-based ingredients, vitamins and minerals.” But unlike those alternatives, in a side-by-side comparison to the generic market milk I had in my fridge, I found the nutrition panel to be nearly identical, if not better.“Just like conventional dairy milk, a serving of Bored Cow has 8 grams of complete protein, amino acids and all, and is an excellent source of calcium, vitamin D and B12,” Berman said.</blockquote><h3>Bored Cow passes the cereal and coffee tests</h3>Lin stated that Bored Cow was similar to 2% milk in taste and texture in her cereal and coffee and, according to Berman, it could be used in the same ways as milk.&nbsp;<blockquote>The viscosity of it in a glass, in cereal, and in my iced coffee mimicked that of 2% or whole milk, and unlike plant milks, didn’t break in hot coffee. Even better news, Berman said: “It froths, foams, cooks and bakes just like cow’s milk.”</blockquote><h3>Real milk is much cheaper</h3>The only downside she reported was pricing, since it was much more expensive per quart than real milk and some families who drink a lot of milk would be hard-pressed to buy Bored Cow's. She hoped that, as it gained popularity and production increased, the price would come down. &nbsp;<h2>Bored Cow has a lot of company &nbsp;</h2>Bored Cow is not the only company developing synthetic milk based on precision fermenting.&nbsp;This tweet by Organic Garden Coach &amp; Business Strategist links to an article by the Non-GMO Project highlighting the price difference between Bored Cow and real milk and reviewing companies in Europe that are developing their own versions of synbio milk.&nbsp;<div class="raw-html-embed"><blockquote class="twitter-tweet">"For example, currently, four 32-oz containers of Bored Cow milk made using Perfect Day’s synbio dairy proteins, cost $26, which is approximately three to four times the cost of a gallon of real organic milk." <a href="https://t.co/f3m1b4SmY9">https://t.co/f3m1b4SmY9</a>— Organic Garden Coach &amp; Business Strategist (@debbyward1) <a href="https://twitter.com/debbyward1/status/1752361295695708271?ref_src=twsrc%5Etfw">January 30, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>Other companies that produce synbio dairy by precision fermentation include the ones below, which were <a href="https://www.nongmoproject.org/blog/new-gmo-alert-animal-free-dairy-products-to-watch-out-for/" target="_blank" rel="noopener noreferrer">reviewed</a> by the Non-GMO Project. These companies also claim, on their websites, that their faux dairy products are equivalent to the real thing yet better for cows, people, and the environment.&nbsp;<a href="https://www.remilk.com/" target="_blank" rel="noopener noreferrer">ReMilk</a> - Real Dairy. No Cows.™"<blockquote>Dairy crafted Remilk's way is healthy and clean, with no cholesterol, lactose, hormones, and antibiotics – just 100% yum without the scum! It’s identical in taste, requires a fraction of the resources and is 100% cruelty-free. Holy cow!</blockquote><a href="https://formo.bio/" target="_blank" rel="noopener noreferrer">Formo</a> - “Cheese. This Time Animal-Free.”<blockquote>To keep our fondues gooey, forests healthy, cheese boards stinky and climate stable, it’s time to dump industrial dairy and start the path to a better food system.</blockquote><a href="https://www.changefoods.com/" target="_blank" rel="noopener noreferrer">Change Foods</a> - maker of synbio cheese.<blockquote>. . . by keeping the cows blissfully uninvolved, we can ensure our cheese contains all the good stuff and none of the nasties.Yes to protein, calcium, and deliciousness. Hold the cholesterol, hormones and antibiotics.10x less water. 100x less land. 5x less energy. 25x less feedstock.</blockquote><a href="https://imagindairy.com/" target="_blank" rel="noopener noreferrer">Imagindairy</a> - “Not all dairy is created equally.”<blockquote>By combining our admiration for dairy, concern for the planet, and expertise in science, we’ve created dairy proteins that possess the same bold flavour, functionality, experience, mouthfeel, and nutrition as the cow-required dairy you’ve always known and enjoyed. Our animal-free dairy products are also lactose-free, growth hormone-free, and cholesterol-free.</blockquote><a href="https://www.newculture.com/" target="_blank" rel="noopener noreferrer">New Culture</a> - “Cow Cheese Without The Cow”<blockquote>We love ‘em all, but for the-love-of-pizza we had to start with mozzarella. Our mozz has the same taste and stretch that you expect from your favorite pie, which is why we’re bringing our cheese to pizzerias first.By the time it’s on your plate, it’s just as melty and creamy as the original. But it’s also animal-free, lactose-free, and planet-friendly. And above all, it makes a killer pizza.</blockquote><h2>Faux dairy where you don't expect it</h2>Synbio milk is being used as an ingredient in food products produced by other companies and about which consumers are likely to be in the dark, as the following tweet by B. Maat shows.<div class="raw-html-embed"><blockquote class="twitter-tweet">The Urgent Company, California Performance Co. and Betterland Foods. Even General Mills now sells products made with synbio milk, according to Bored Cow. Perfect Day also lists partnerships with Nestlé, Mars, Myprotein, Renewal Mill and Bel Group— b. maat (@bmaat99) <a href="https://twitter.com/bmaat99/status/1740343277684179206?ref_src=twsrc%5Etfw">December 28, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div><h2>Is fake milk truly equivalent to cow milk?</h2>As Frontline News has shown, the <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> made by manufacturers of lab-grown meat don't hold up, nor do the <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> of environmentalists and government authorities promoting the use of EV cars.&nbsp;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. That will be the topic of our next article on synbio milk.Related articles:<ul><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>

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Nutrition

Technology

wokeness

'Even General Mills now sells products made with synbio milk'

Got milk? It might not be real

Over 60 years have passed since the thalidomide disaster, when around 10,000 babies were born deformed due to a drug their mothers had taken during pregnancy. Thalidomide was <a href="https://usthalidomide.org/german-family-behind-thalidomide-apologises-to-victims/" target="_blank" rel="noopener noreferrer">promoted </a>as being “as harmless as a sugar cookie,” but almost half of all children exposed to the drug in the womb <a href="https://www.dw.com/en/thalidomide-babies-birth-defects-caused-by-a-harmless-pill-60-years-ago/a-59952155" target="_blank" rel="noopener noreferrer">died </a>shortly after birth. To this day, the majority of healthcare providers are still extremely cautious when it comes to pronouncing any drug safe for pregnant women. Quietly, however, researchers and others are working to change this, and while they claim to have the welfare of pregnant women in mind, their plans indicate that other interests are also at play.&nbsp;<ul style="list-style-type:disc;"><li>An article in a prestigious medical journal points the way toward research on pregnant and lactating women</li><li>Main obstacle: fear of legal liability</li><li>Pregnant women no longer considered “vulnerable” in official guidelines; including them in research to become the default position</li><li>Permitted level of risk raised above “minimal” and to be determined by “stakeholders" (which include Pharma)</li><li>Focus on providing researchers and Pharma with protection from liability in case of injury</li><li>Doctors &amp; other healthcare workers (broadly defined to includes doulas and others) to be barred from warning pregnant women against use of medications</li><li>Doctors to be co-opted to recruit patients as trial participants, using both inducements and implied threats</li><li>Large-scale "public awareness” campaign with the aim of creating a “cultural shift”</li></ul>&nbsp;Breaking tabooA recent article in <a href="https://jamanetwork.com/journals/jama/fullarticle/2817621?guestAccessKey=8b28a9e3-629c-4219-b51d-a2548613cb26&amp;utm_source=silverchair&amp;utm_medium=email&amp;utm_campaign=article_alert-jama&amp;utm_content=olf&amp;utm_term=041024&amp;adv=" target="_blank" rel="noopener noreferrer">JAMA </a>(the Journal of the American Medical Association), written by Margaret Foster Riley JD, is titled “Including Pregnant and Lactating Women in Clinical Research; Moving Beyond Legal Liability,” and the clue is in the title. In this article, Prof. Riley notes that research into use of drugs by pregnant and lactating women is being held back by fears of legal action if anything goes wrong, but that such fears are unfounded.<blockquote>... until now, there has never been a systematic examination of legal liability in the US for the inclusion of pregnant and lactating women in clinical research and whether this fear of liability is supported by evidence. A new report from the National Academies of Sciences, Engineering, and Medicine asserts that while fear of legal liability is pervasive, actual legal liability is not, and is often conflated with other concerns, such as reputational risk, increased costs, and trial complexity.</blockquote>Riley also expresses concern that the lack of research means that women many cease taking necessary drugs while pregnant or nursing, with adverse results; or that they take drugs regardless, without having safety data to inform them. While her concerns may be well-founded, it is noteworthy that she does not mention even in passing the risk that research itself would pose to women in vulnerable states.<blockquote>By excluding pregnant and lactating women from clinical studies due to perceived liability risks, these populations, as well as their fetuses and breastfeeding children, are harmed. In an ideal world, pregnant and lactating women would have the ability to make informed decisions that optimize their perinatal and postpartum health and the health of their children…</blockquote>Riley has been involved in crafting recommendations for Congress, which, several years ago, tasked the <a href="https://nap.nationalacademies.org/read/27595/chapter/2#3" target="_blank" rel="noopener noreferrer">National Academies</a> of Science, Engineering, and Medicine with examining the issue of research and associated liability. Their 83-page <a href="https://www.nichd.nih.gov/sites/default/files/inline-files/PRGLAC_Implement_Plan_083120.pdf" target="_blank" rel="noopener noreferrer">report</a> contains a wealth of information from which one may derive the direction in which research is going, not only in the United States, but also in Europe and beyond.Following is an assessment of the report with selected quotations.&nbsp;Fetuses and neonates no longer considered “vulnerable”Pregnant women have historically been considered “vulnerable” when it comes to research (due to concern for the fetus), as have other populations such as prisoners, who are vulnerable to being coerced into participation, and also children, who are unable to give informed consent. <a href="https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf" target="_blank" rel="noopener noreferrer">No longer</a>. The report's recommendation that pregnant women no longer be classified as vulnerable has already been implemented, with the report’s authors claiming that:<blockquote>Not surprisingly, a consensus has arisen in recent years that the more ethical and responsible course would be to include pregnant and lactating women in clinical research.&nbsp;</blockquote>&nbsp;Pregnant women to be included in trials absent “strong” evidence of riskThe report also recommends a paradigm shift in the attitude toward including pregnant and/or lactating women in clinical trials, making inclusion the default position:<blockquote>Instead of justifying inclusion of pregnant women or lactating women in clinical research, investigational new drug applications (INDs) for new drugs or biological products (including a proposed study for a new indication to an already approved drug or licensed biological product) should now include justification for excluding these groups…</blockquote>Pharmaceutical companies will only be granted a waiver from including these populations if:<blockquote>… available evidence strongly suggests that the drug or biological product would be ineffective or unsafe in pregnant women and/or lactating women…</blockquote>&nbsp;Permitted level of risk raised above “minimal”The official code of ethics governing the protection of those who participate in domestic research is called the <a href="https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/principal-regulations/index.html#:~:text=The%20Common%20Rule%20generally%20requires,in%20language%20they%20would%20understand." target="_blank" rel="noopener noreferrer">Common Rule</a>. Clause 46:204 governing “Research involving pregnant women or fetuses” <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46" target="_blank" rel="noopener noreferrer">includes</a> as one of the necessary conditions permitting this research:<blockquote>(d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal&nbsp;and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means... [emphasis added]</blockquote>One of the report’s recommendations is to raise the permitted level of risk entailed in research, permitting not only research “of minimal risk” but also research that involves a “minor increase over minimal risk” (as is currently the rule for research on children).&nbsp;‘Stakeholders’ to decide what constitutes acceptable riskWho will define what constitutes a “minor increase” in risk? The report states:<blockquote>… experts and stakeholders should be convened to reach consensus on the definition of what constitutes a minor increase over minimal risk for both the pregnant woman and the fetus…</blockquote>Elsewhere, it defines stakeholders as “government, industry [i.e., Pharma], clinicians, and women":<blockquote>... stakeholders, including industry, could work on topics of mutual interest to further research on therapeutics used by pregnant women and lactating women. Examples include agreeing on the parameters of reproductive/toxicity studies, such as the weight of evidence for reproductive or teratogenic risk required, data standards, and developing a business case around the risk of studying drugs earlier in pregnant women…</blockquote>The report is light on what can be practically done to ensure that research itself does not pose dangers to women, fetuses, and neonates, merely mentioning the need for more funding to develop more preclinical models and methods, given that, “Current preclinical (animal) models have limitations for extrapolating the findings to humans.”<blockquote>Appropriate preclinical studies, such as reproductive toxicology studies using animal models, should be conducted for therapeutics still in development with the potential to be used by pregnant women and/or lactating women. Based on data from preclinical studies, decisions about whether to include pregnant women or lactating women in phase III clinical trials should be refocused; the assumption should be inclusion, with a decision on exclusion only if clearly justified by the preclinical data.&nbsp;</blockquote>&nbsp;Protection for researchers — but what about mothers?It is illegal to bribe citizens to participate in medical research which involves a risk (as much, if not all, medical research does). Providing a substantial safety net for those inadvertently injured due to participation in a clinical trial is not considered an improper inducement. The report, however, does not mention providing enhanced compensation to reassure women that if anything goes wrong, they’re covered. Rather, it focuses on “providing researchers with protection against liability."<blockquote>Convene a panel ... to make recommendations for conducting research that substantially mitigates or avoids incurring liability (absent negligence or malfeasance). These recommendations may include ways to maximize the use of informed consent procedures ... without waiving research participants’ legal rights, while still providing researchers with protection against liability.&nbsp;</blockquote>The report also suggests using the Vaccine Injury Compensation Program (VICP) as a model for regulating compensation for mothers injured due to their involvement in a clinical study.&nbsp;Doctors who don’t play along may lose their licensesNext, the report turns its attention to the practicalities of recruiting women to clinical trials, and notes that doctors are in a unique position to influence their patients, since,<blockquote>… studies repeatedly show that healthcare providers remain a trusted source of information about health…</blockquote>Furthermore, “any hesitation on the part of the trusted healthcare provider about participation diminishes the chance” that women will join a trial, so various measures are proposed to ensure that healthcare providers actively promote participation in research:<blockquote>… continuing medical education (CME) modules that would be linked to maintenance of board certification or licensure. In addition to content about current knowledge of the therapeutics used by pregnant women and lactating women, these modules should explain how to access and how to communicate this information to a diverse group of potential participants, including information about balancing the risk of taking a medication with that of not treating an underlying condition... [emphasis added]</blockquote>&nbsp;Warning against drug use during pregnancy or lactation to be outlawedFor those doctors who succeed in recruiting patients to clinical trials, the report suggests a program of rewards:<blockquote>Explore incentives for healthcare providers to discuss clinical trials with their patients … Behavioral incentives, such as formal feedback that gives credit to healthcare providers for getting their patients involved in trials, or grading metrics from payers, should also be included in this discussion.</blockquote>However, not only doctors are to be included in the new drive to recruit pregnant and lactating women. The report mentions many other groups who are to be co-opted:<blockquote>… healthcare providers (including but not limited to clinicians, pharmacists, lactation consultants, dietitians, nursing and allied health professionals, nurse midwives, nurse practitioners); academic and industry researchers; medical, health, and pharmacy associations; teratology information specialists and genetic counselors; and pregnant women and lactating women and family members ... organizations representing women’s and family health interests, such as doula and social work organizations...</blockquote>If the report’s recommendations are adopted, all the above-mentioned groups will be barred from warning their patients or clients against using any medication during pregnancy or lactation unless there is clear evidence of risk:<blockquote>For example ... until more studies on medications used by lactating women are completed, the interim messaging to women and their healthcare providers may only reflect that data are lacking, and that they must balance risks and benefits&nbsp;of medication use with continuation of breastfeeding [emphasis added].</blockquote>How healthcare providers can calculate the risk-benefit ratio in the absence of data is not explained. Furthermore, the report stresses that data that becomes available in the future due to new research is to be shared with doctors, who will be responsible for presenting it in the form of “handouts written for a lay audience.” That is to say, the raw data will not be made available to the public.&nbsp;Aim: To create a ‘cultural shift’Parallel to its strategy vis-à-vis the healthcare profession, the report recommends a public awareness campaign to encourage pregnant and lactating women to participate in scientific research:<blockquote>Rec[ommendation]. 5: Create a public awareness campaign to engage the public and healthcare providers in research on pregnant women and lactating women. For any cultural shift to occur, the associated behavioral change requires a targeted communications strategy. When communicating information relevant to treating pregnant women and lactating women, messages must be concise, consistent, tailored, and actionable for women and their healthcare providers … Highlight the importance of research on therapeutic products in pregnant women and lactating women, including the impact of not taking the medication during pregnancy and lactation…</blockquote>To provide maximal impact for public messaging, the report suggests that anecdotal evidence be used, even though in general, the scientific community dismisses this kind of evidence as either inferior or misleading and irrelevant:<blockquote>To assist in illustrating these issues, educational efforts need to include real-life stories about pregnant or lactating women’s experiences to illustrate absolute risk, relative risk, and the trade-off of risks and benefits. These stories may include the consequences of stopping treatment for ongoing conditions, failure to treat emerging conditions, and unintended incorrect dosing due to the physiological changes during pregnancy. Once developed, these messages should be pilot tested to ensure comprehension and acceptability prior to being rolled out to a wider audience.</blockquote>&nbsp;Tax breaks for Pharma companies that include pregnant and/or lactating women in clinical studiesWhile behavioral incentives are proposed to encourage doctors to recruit clinical trial participants, for another group of stakeholders, the pharmaceutical companies, the report suggests financial inducements, as JAMA’s article describes:<blockquote>... the report’s recommendations include a call for Congress to develop incentives, such as extended market exclusivity or tax breaks, to encourage the conduct of clinical studies with pregnant and lactating women…</blockquote>In fact, the government-appointed task force on research in this area is already collaborating with European Union partnerships between industrial and philanthropic interests, such as the ConcePTION initiative,<blockquote>… a public-private partnership between the European Union and the European pharmaceutical industry to develop the next generation of vaccines and medications for pregnant women and lactating women...</blockquote>The report also notes that,<blockquote>The Bill and Melinda Gates Foundation is funding MHRA in the UK to create repository of information for assessing drug exposure in pregnancy…</blockquote>&nbsp;Abortion laws and experimenting on pregnant womenProf. Riley notes that the recent Supreme Court ruling on abortion “could further discourage the conduct of clinical research with pregnant women.” Her concern may be well-founded, but the parallel between laws governing clinical trials and those governing abortion is an intriguing one.It is claimed, although reliable data are hard to come by, that most pregnant women (perhaps as many as 70 percent) and the majority of lactating women (over 50 percent) use medications during these periods. Riley’s main justification for broadening the permissibility of research rests on the assumption that “drug use is happening anyway, so we should at least find out if it’s safe (even if we risk a few women and babies along the way).” A similar argument is used by those in favor of “safe, legal, and rare” abortions.&nbsp;However, just because people are doing something “anyway” does not mean it should be condoned or encouraged by the government. Furthermore, doing so may have deleterious effects that legislators often fail to anticipate.&nbsp;Large, uncontrolled experiments?Riley also notes that:<blockquote>The absence of a sufficient evidence base means that almost all pregnant and lactating women with a condition for which a medical product might be appropriate are, in effect, participants in large, uncontrolled experiments that typically will not produce useful data.</blockquote>Unwitting and often unwilling participants in another “large, uncontrolled experiment” may have something to say on the topic…

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US News

Healthcare providers to be co-opted in recruiting trial participants; Pharma to be granted tax breaks

Exclusive: Drug research on pregnant women could become the norm

By Alex Newman&nbsp;What comes after LGBTQIA+ in the rainbow alphabet being taught to captive children? Many critics of the movement assumed it would be P for pederasty and pedophilia, and in some places, it is. But in Australia, it seems that “B” might be the next letter added to the ever-longer list of sexual and gender deviance.&nbsp;According to whistleblowers and outraged parents, children as young as 13 in a South Australia school were forcibly taught about sexual activities with animals as part of a “queer” LGBTQIA+ “sex education” class. The revelations drew outrage from parents and half-hearted apologies from “education” officials.&nbsp;The presentation in question at Renmark High School was delivered to 9th&nbsp;grade students under the guise of teaching about “respectful relationships.” It was so graphic and grotesque that multiple girls asked to leave the classroom to go to the “bathroom” just to get away before seeking help from their parents, according to ABC News Australia.&nbsp;Some students spoke out. “There was a slide for what the ‘plus’ means [in LGBTQIA+], and they just started randomly saying words that no-one knew, like bestiality,” explained Emelia Wundenberg, 14, one of the victims of the homosexuality- and transgenderism-promoting session. “It was on the board when they were showing what the ‘plus’ meant.”&nbsp;After the first refence, the presenter then got even more graphic, explaining human sexual acts with animals in detail while implying that it was normal and accepted by homosexuals, transgenders, bisexuals, and others. “They said [the queer community] just accepts all of it, even though … isn’t it illegal?” Wundenberg wondered.According to Wundenberg, the “sex educator” who presented the material was also extremely graphic when describing her own sexual perversions and fetishes, describing herself as “confused.” The presenter also said that growing up she could not tell whether she idolized people or wanted to have sexual relationships with them.&nbsp;Another student, Courtney White, said she felt “confused” and “blindsided” by the indoctrination session. Among other concerns, White, 14, said teachers left the students alone with the “queer” sex ed staff. And then the brainwashing began. “The first slide of the PowerPoint on the board was ‘You can see queerly now’ and ‘No point hiding,’” she said.&nbsp;As the perversion became increasingly outrageous, Courtney and other girls became so uncomfortable that they had to leave. “We’re all just sitting there like, ‘What the hell? What are we doing here? Why are we learning about animals having sex with humans?’” she said. “It was really disgusting, it was really uncomfortable.”The experience was so extreme that some parents have now formally pulled their children from the school. “My kids are in limbo,” said Courtney’s mom after removing all three of her children. “They’re not in an education department at this point. I’m not putting them anywhere until I know this won’t happen again.”The school, meanwhile, is in damage-control mode, apologizing to parents and offering “counseling” to the traumatized students. “Sexuality educator” and “LGBTQIA+ inclusion” advocate Eleonora Bertsa-Fuchs, who as a “nonbinary” uses “Mix” or “Mx.” Instead of Mr., Ms., or Mrs., said it was important that all children learn about every kind of perversion.However, she added, lessons on gender confusion and perverse sex acts including sodomy, fornication, and more should be conducted in a way that is “safe and appropriate.” Ironically, perhaps, she claimed the LGBTQIA+ “community” was the real victim in this latest scandal, too.The explosive news comes just weeks after a transgender UN “expert” from Australia working on global regulations for children’s medical care from the World Health Organization was exposed sharing photos of bestiality with dogs. The expert, a woman impersonating a man who uses the name “Teddy Cook,” is an LGBTQ+ “community health” director in Sydney.&nbsp;Another perverted sex fiend down under, a popular academic from Charles Darwin University who specialized in crocodiles, was arrested late last year and charged with sexually abusing dozens of dogs, the BBC reported. The perversion was so horrific the judge asked security officers to exit the court. The perpetrator, Adam Britton, was also charged for child-abuse material.&nbsp; &nbsp;In California, as first exposed by The Newman Report years ago, government schools have already been caught normalizing sex between adults and children. When confronted by a mom about why they were teaching pedophilia, Brea Olinda School District Assistant Superintendent responded that raping children is a “sexual orientation that has existed in history” and so, “it’s really important” to teach it. &nbsp;<img class="image_resized" style="width:384px;" src="https://i0.wp.com/www.freedomproject.com/wp-content/uploads/2021/11/3364780_1225x377_2500.jpg?resize=696%2C214&amp;ssl=1" alt="">Just as critics warned, it was only a matter of time before the perversion alphabet being forced on captive children in government schools grew to include more letters. It seems that P and B may be next as Western societies turn away from God, truth, morality, and common sense. Unfortunately, the devastating harm done to children is just getting started.&nbsp;Originally published at <a href="https://www.freedomproject.com/2024/04/10/tnr20240410/">FreedomProject Media</a>.<a href="https://libertysentinel.org/author/admin/">Alex Newman</a> is an award-winning international journalist, educator, author, and consultant who co-wrote the book “Crimes of the Educators: How Utopians Are Using Government Schools to Destroy America’s Children.” He writes for diverse publications in the United States and abroad.

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