A Texas judge Friday dismissed a lawsuit against Pfizer and clinical site inspection company Ventavia because they were only accused of defrauding the public during COVID-19 vaccine trials, but not the US government.Ventavia whistleblower Brook Jackson, who was a clinical site reviewer for two of the vaccine’s trial sites, was fired in 2020 after reporting “blatant” and “widespread” misconduct she witnessed to the FDA, including “numerous violations of the US Food and Drug Administration (FDA) Code of Federal Regulations every, single day.”&nbsp;Jackson<a href="https://frontline.news/post/yoohoo-ventavia-whistleblower-faces-off-against-pfizer-ventavia"> alleged</a> that Pfizer, Ventavia and ICON, another clinical research group, “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question,” and also “concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.”&nbsp;Pfizer&nbsp;<a href="https://frontline.news/post/pfizer-moves-to-dismiss-lawsuit-by-claiming-government-was-co-conspirator">argued&nbsp;</a>last year that even if the allegations are true, the US government endorsed it by purchasing 100 million doses for $1.95 billion. Therefore, Pfizer argued, the US government cannot have been defrauded.When Ventavia fired her, Jackson claimed they violated the False Claims Act (FCA), which protects whistleblowers:<blockquote>Any employee, contractor, or agent shall be entitled to all relief necessary to make that employee, contractor, or agent whole, if that employee, contractor, or agent is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts done by the employee, contractor, agent or associated others in furtherance of an action under this section or other efforts to stop 1 or more violations of this subchapter.</blockquote>But Judge Michael J. Truncale dismissed Jackson’s complaint last week, saying that according to the law, the False Claims Act (FCA) only applies to whistleblowers who engage in “protected activity”, which means being “motivated by a concern regarding fraud against the government”.Unfortunately for Jackson, she was more concerned about Pfizer’s and Ventavia’s fraudulent actions against the public, which was later forced to take the vaccine, and not as concerned about the government.“At no point does she allege that she was concerned about, or alerted Ventavia or the FDA to, potential ‘fraud against the government’,” reads the judge’s&nbsp;<a href="https://storage.courtlistener.com/recap/gov.uscourts.txed.203248/gov.uscourts.txed.203248.96.0.pdf">order</a>. “Rather, she alleges that she complained about participant safety and regulatory, protocol, and HIPAA violations. But that is not protected activity under the FCA’s retaliation provision — internal complaints about patient safety, or protocol and regulatory violations, are not the same thing as complaining about defrauding the Government.”Jackson’s attorney Robert Barnes did not immediately respond to&nbsp;Frontline News’&nbsp;request for comment, but he has vowed to appeal.“The court requires we appeal to hold Pfizer accountable in the [Brook Jackson] case, and we will be doing precisely that. #PfizerLiedPeopleDied,” Barnes tweeted.<div class="raw-html-embed"><blockquote class="twitter-tweet">The court requires we appeal to hold Pfizer accountable in the <a href="https://twitter.com/IamBrookJackson?ref_src=twsrc%5Etfw">@IamBrookJackson</a> case, and we will be doing precisely that. <a href="https://twitter.com/hashtag/PfizerLiedPeopleDied?src=hash&amp;ref_src=twsrc%5Etfw">#PfizerLiedPeopleDied</a>— Robert Barnes (@barnes_law) <a href="https://twitter.com/barnes_law/status/1641915329365540864?ref_src=twsrc%5Etfw">March 31, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>

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Legal News

Pfizer

'At no point does she allege that she was concerned about . . . potential ‘fraud against the government’

Judge dismisses lawsuit against Pfizer for only defrauding public, not government

<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>

milk mustache.jpg

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…

preg woman.jpg

Medical

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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What comes after LGBTQIA+ in government schools?

Bestiality Taught in Australian School’s “Queer” Sex Class

<h2>The Biden Administration keeping pornography in the public schools</h2>Most Americans believe the health and well-being of children should always be first and foremost, yet child pornography has now found its way into public school libraries. This has sparked a fierce debate among parents and officials about what children should be exposed to, as Frontline News recently <a href="https://frontline.news/post/pornography-now-in-public-school-libraries-did-you-know" target="_blank" rel="noopener noreferrer">reported</a>. &nbsp;While parents all over the country have been fighting local school boards and some states have passed legislation giving parents control over sexually explicit materials in schools, the federal government may have just made the parents' job more difficult. A Fox News report by Hannah Grossman in July 2023 <a href="https://www.foxnews.com/media/biden-admin-disrupting-parents-removing-pornography-schools-frighting-civil-rights-office" target="_blank" rel="noopener noreferrer">explained</a> that the Biden Administration “is starting to weaponize [the Department of Education Office of Civil Rights] to combat parents' efforts in local districts under the threat of withholding funding, according to education experts.”Grossman quoted Max Eden, a research fellow focusing on K-12 education at the American Enterprise Institute who said “[t]he move signals that the DOE can investigate a district for simply reviewing parents' concerns about sexually explicit content in schools.”Oli London tweeted highlights from the Fox News article:&nbsp;<div class="raw-html-embed"><blockquote class="twitter-tweet">The Biden administration has began weaponizing the Department of Education’s Office of Civil Rights to punish schools that remove sexually explicit books targeting children from libraries. The DOE can investigate a school district simply for reviewing parental concerns about… <a href="https://t.co/V3KGKRAW1L">pic.twitter.com/V3KGKRAW1L</a>— Oli London (@OliLondonTV) <a href="https://twitter.com/OliLondonTV/status/1682191529341861888?ref_src=twsrc%5Etfw">July 21, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>In another article, Grossman <a href="https://www.foxnews.com/media/rhode-island-dad-accuses-district-sick-agenda-use-abuse-children-pornography-book" target="_blank" rel="noopener noreferrer">reported</a> on a Fox News Digital interview with Rhode Island father Rob Chiaradio who has been fighting the Westerly School District board to remove the book “Gender Queer,” which includes pornographic images, from its library bookshelves. Chiaradio told Fox that he believed that schoolchildren are being used and abused for a sick agenda:<blockquote>Rather than teaching these kids about math, English, and science…, these kids are being used and abused in order to help these people achieve some kind of sick agenda that they have.</blockquote>He also expressed concern that “destroying” children is one way in which officials may ultimately take down the country:<blockquote>These… so-called leaders of the district are trusted by these kids. The only thing that I can think of here is that these people have other motivations," he said. "And that's the thing that really, really gets me. Because the best way to take down a country or a society… is to destroy a generation of its youth.".</blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">"Rather than teaching these kids about math, English, and science, these kids are being used and abused in order to help these people achieve some kind of sick agenda that they have," Robert Chiaradio told Fox News Digital in an interview. <a href="https://t.co/KhZM1dydVf">https://t.co/KhZM1dydVf</a>— (@DIHart1727) <a href="https://twitter.com/DIHart1727/status/1616828379914715141?ref_src=twsrc%5Etfw">January 21, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
</div><h3>&nbsp;</h3><h3>Books in school libraries “unequivocally erotica”</h3>Senior Fellow of the Education Freedom Center for the Independent Women’s Forum Nicole Solas <a href="https://docs.house.gov/meetings/ED/ED14/20231019/116471/HHRG-118-ED14-20231019-SD004.pdf" target="_blank" rel="noopener noreferrer">penned</a> a Written Statement Before the U.S. House Committee on Education and the Workforce Hearing: Combatting Graphic, Explicit Books in School Libraries. In her October 19, 2023, statement, she described the gravity of the situation including what is in the pornographic and sexually explicit books available to public school children.&nbsp;<blockquote>. . . This is not an occasional problem. On the contrary, the amount of sexually explicit books in school libraries is extensive and vast. . . . These books do not simply provide clinical sex education describing anatomy and reproduction. They contain numerous pornographic passages and pictures meant to instruct children on sexual pleasure, sexually excite children, or push a radical, ideological viewpoint of sex and sexuality. In many cases, these books are unequivocally erotica with both homosexual and heterosexual storylines framed against the youthful backdrops of high school, family, and friends. In one reported incident, hardcore pornography for adults was removed from a high school library and you can read an excerpt.&nbsp;</blockquote>Solas included a list of the books and links to excerpts, imploring the committee members to “take some time to review the listed excerpts and graphics list provided. . . You will be astonished,” she wrote.<h3>Significant harm to children</h3>To explain the impact that pornography has on children, Solas referred to the American Academy of Pediatrician's description of its harm to children:<blockquote>These negative effects include mental disturbance and unrest for the young school age child, including acting out and violent behavior. Because of its harmfulness to children, pornography must never be used as a tool to teach children human sexuality.”&nbsp;</blockquote>The Academy is quite <a href="https://acpeds.org/position-statements/the-impact-of-pornography-on-children" target="_blank" rel="noopener noreferrer">detailed</a> in its description of the harms that pornography holds for elementary school children. The academy lists maladaptive behaviors and psychopathology that young children who have viewed pornography may display.<blockquote>. . . Pornography exposure at these young ages often results in anxiety for the child. &nbsp;Children also report feelings of disgust, shock, embarrassment, anger, fear, and sadness after viewing pornography. These children can suffer all of the symptoms of anxiety and depression. They may become obsessed with acting out adult sexual acts that they have seen, and this can be very disruptive and disturbing to the child’s peers who witness or are victimized by this behavior. Children under twelve years old who have viewed pornography are statistically more likely to sexually assault their peers. In sum, children exposed to pornographic material are at risk for a broad range of maladaptive behaviors and psychopathology.</blockquote>The Academy referred to a study done in the 1980s to explain the effect pornography had on older adolescents and young adults, They found that their moral compass was skewed and that their attitudes toward marriage, rape, and fidelity were compromised.&nbsp;<blockquote>The following observations were noted regarding young adults exposed to pornography compared to the control group:<ul><li>Male subjects demonstrated increased callousness toward women.</li><li>Subjects considered the crime of rape less serious.</li><li>Subjects were more accepting of non-marital sexual activity and non-coital sexual practices such as oral and anal sex.</li><li>Subjects became more interested in more extreme and deviant forms of pornography.</li><li>Subjects were more likely to say they were dissatisfied with their sexual partner.</li><li>Subjects were more accepting of sexual infidelity in a relationship.</li><li>Subjects valued marriage less and were twice as likely to believe marriage may become obsolete.</li><li>Men experienced a decreased desire for children, and women experienced a decreased desire to have a daughter.</li><li>Subjects showed a greater acceptance of female promiscuity.</li></ul></blockquote><h3>UK concerned about effects of porn on kids, too</h3>A 2023 <a href="https://www.childrenscommissioner.gov.uk/resource/pornography-and-harmful-sexual-behaviour/" target="_blank" rel="noopener noreferrer">report</a> by the UK's Children's Commissioner regarding online pornography, in preparation for an online safety bill, emphasizes the harm that pornography inflicts on children. The report was the result of an analysis of 502 cases reports of child-on-child sexual abuse. The commissioner reported that it shapes and fuels violence against women and girls and promotes harmful sexual behaviors and children abusing children. Much of the abuse is like that depicted in pornography. &nbsp;<blockquote>It is incredibly concerning that I found references to specific acts of sexual violence commonly seen in pornography in half of the interviews carried out following these cases of sexual abuse. Additional review of some of these cases found children suggesting direct links between pornography exposure and the harmful sexual behaviour exhibited.</blockquote><h2>&nbsp;</h2><h2>Books that help parents teach kids to stay safe</h2>Fortunately, there are books to help parents educate their children to recognize pornography when they see it and know what to do, as Louise Chambers <a href="https://www.theepochtimes.com/bright/porn-proof-your-children-mom-pens-book-after-friends-son-sexually-abused-his-siblings-5610160" target="_blank" rel="noopener noreferrer">reported</a> for The Epoch Times. <a href="https://www.defendyoungminds.com/about" target="_blank" rel="noopener noreferrer">Kristen Jensen</a> who was shocked to discover that a friend's son sexually abused his siblings after exposure to pornography was surprised that she could find no resources to help the family and soon found herself on a mission to address the issue.&nbsp;To do this, Chambers explained, Jensen met with parents, read a lot, and watched videos on YouTube by experts on the neurological effects of pornography. Her efforts have resulted in the books “Good Pictures Bad Pictures: Porn-Proofing Today’s Young Kids“ for children aged 7 to 11, and ”Good Pictures Bad Pictures Jr.: A Simple Plan to Protect Young Minds“ for children aged 3 to 6, and other resources for parents and children.&nbsp;<blockquote>Mrs. Jenson’s book offers an age-appropriate definition of pornography so kids can recognize porn when they see it.“Bad pictures show the private parts of the body that we cover with a swimsuit,” reads the book, which goes on to explain why these “bad pictures” are harmful, and offers a plan so that kids know what to do when they see them.Mrs. Jenson said: “Educating kids on the harmful effects of pornography gives them good reasons to reject it. The book for older children describes the process of addiction, while the book for younger children presents the analogy of ‘picture poison.’”</blockquote>The books appear to have been successful at accomplishing their goals, as Chambers shared Jensen's stories about two children's experiences with recognizing pornography and reacting appropriately. The first happened on the school playground where one child showed porn to another child.<blockquote>One mom shared on social media that she read ‘Good Pictures Bad Pictures’ to her 9-year-old son, and three days later, he was shown pornography by another student on the playground during recess. Her son came home and told his mom what had happened. He said, ’I was scared, but I knew what to do.' Can’t you just feel the burden coming off of his young shoulders? No child deserves to face the porn industry alone!</blockquote>The second incident occurred when an adult approached a child, showing him porn on his cell phone.&nbsp;<blockquote>The second anecdote came from a mother who had read “Good Pictures Bad Pictures” to her 6-year-old son. The incident occurred while dining at a friend’s home.Recounting the incident, Mrs. Jenson said: “A renovation project caused their friends to put the children’s toys downstairs, so each child was allowed to run down and grab a toy to play with. While the 6-year-old stayed looking at the toys, the man who rented the downstairs apartment approached him and showed him a video of gay porn on his phone. The boy immediately recognized that he was seeing porn, and he ran up and told his mom. He got himself out of a very harmful situation.”&nbsp;</blockquote><h3 style="margin-left:auto;">Look inside the books</h3>Below are two book reviews of Good Pictures Bad Pictures and Good Pictures Bad Pictures Jr.&nbsp;The first is by Katie “a wife and home school mom of 6 kids who range from 13 years to 4,” on her YouTube channel “Life in the Mundane.”&nbsp;<div class="raw-html-embed"><iframe width="853" height="480" src="https://www.youtube.com/embed/wWr9-3PYah0" title="The BIGGEST Mistake We Can Make When Protecting Our Kids Online" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen=""></iframe></div>The second is by Sarah Kimmel on her channel Family Tech. She is a “Microsoft Certified IT Manager, who is also a mom. She currently helps families understand and manage the technology in their homes.”<div class="raw-html-embed"><iframe width="853" height="480" src="https://www.youtube.com/embed/kHwQkLW8Mlk" title="Unveiling the hidden gems in Good Pictures Bad Pictures Jr and the Standard Version - Book Review" 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 a day and age when parents are being marginalized and bypassed, when it comes to their children's welfare, these books can give parents a little peace of mind, knowing they have a resource to help their children navigate a potentially less-than-friendly world.&nbsp;Learn more:<ul><li><a href="https://www.defendyoungminds.com/" target="_blank" rel="noopener noreferrer">Defend young minds</a> (Jensen's website with additional resources)</li><li><a href="https://www.truthloveparent.com/taking-back-the-family-blog/tlp-339-good-pictures-bad-pictures-kristen-jenson-interview-part-1" target="_blank" rel="noopener noreferrer">Taking back the family</a></li><li><a href="https://www.psychologytoday.com/us/blog/family-and-trauma/202308/silent-educator-the-impact-of-porn-on-young-minds" target="_blank" rel="noopener noreferrer">Silent Educator: The Impact of Porn on Young Minds</a></li><li><a href="https://www.commonsensemedia.org/videos/6-things-to-do-if-your-kid-sees-pornography" target="_blank" rel="noopener noreferrer">6 Things to Do If Your Kid Sees Pornography</a></li><li><a href="https://www.bbc.com/news/technology-64451984" target="_blank" rel="noopener noreferrer">Children as young as nine exposed to pornography</a></li><li><a href="https://www.catholiceducation.org/en/marriage-and-family/parenting/should-we-teach-kids-about-porn-s-harms-yes-and-here-s-how.html" target="_blank" rel="noopener noreferrer">Should We Teach Kids about Porn's Harms? Yes, and Here's How</a></li><li><a href="https://aifs.gov.au/research/research-snapshots/effects-pornography-children-and-young-people" target="_blank" rel="noopener noreferrer">The effects of pornography on children and young people</a></li><li><a href="https://learning.nspcc.org.uk/research-resources/2022/helplines-insight-briefing-legal-but-harmful-content" target="_blank" rel="noopener noreferrer">Children's experiences of legal but harmful content online</a></li></ul>Related articles:<ul><li><a href="https://frontline.news/post/pornography-now-in-public-school-libraries-did-you-know" target="_blank" rel="noopener noreferrer">Pornography now in public school libraries. Did you know?</a></li><li><a href="https://frontline.news/post/appellate-court-upholds-texas-right-to-protect-children-from-online-porn">Appellate court upholds Texas' right to protect children from online porn</a></li><li><a href="https://frontline.news/post/virginia-school-board-official-sworn-in-on-child-pornography-books">Virginia school board official sworn in on child pornography books</a></li></ul>

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