Category: F.D.A.

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Lipid Nanoparticles and mRNA Shots – David Gortler, Robert Malone 9/13/23

Source: rwmalonemd.substack.com

In response to the worldwide-spread of COVID-19, a disease caused by Coronavirus SARS-CoV-2, several pseudo-mRNA “gene therapy”-based products were rapidly developed and deployed as prophylactic vaccines.  In contrast to recombinant viral “gene therapy”-based vaccines such as those developed by Janssen (J&J) and Astra-Zeneca, these RNA products employ non-viral self-assembling Lipid NanoParticle (LNP) technology to deliver genetic information coding for a viral protein (SARS-CoV-2 Spike) into the cells of the patient.  Each of these complicated combination products, which include both a biological component (the RNA) and a complex new ingredient (the LNP), were brought to market by private pharmaceutical companies in a rapidly assembled government-corporate collaboration, operating at “warp speed.”

Continue reading “Lipid Nanoparticles and mRNA Shots – David Gortler, Robert Malone 9/13/23”

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Pfizer Documents Show COVID-19 Vaccines Contain Potentially Harmful ‘Modified’ RNA, not mRNA – Megan Redshaw, J.D. 8/23/23

Source: TheEpochTimes.com

Although we’ve been told Pfizer’s COVID-19 vaccine is manufactured with harmless messenger RNA (mRNA), the U.S. Food and Drug Administration’s (FDA) product label shows it contains artificially modified RNA—a key ingredient that is not naturally occurring and poses a substantial risk to human health.

Continue reading “Pfizer Documents Show COVID-19 Vaccines Contain Potentially Harmful ‘Modified’ RNA, not mRNA – Megan Redshaw, J.D. 8/23/23”

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Once Again, the FDA Admits it Lied to us. And Once More, we Yawn – Jonathan Cook 8/21/23

Source: jonathancook.substack.com

The reality is that most of us are not ready for the truth. We want reassurance. We cling to our comfort blankets because the idea that we live in a world in which our and our families’ interests are not paramount is too disturbing.

The idea that our fates are entirely dependent on a giant Ponzi scheme that might come crashing down at any moment from any one of multiple design flaws – an ecological crisis, a nuclear catastrophe, a pandemic or a hubristic mis-step with Artificial Intelligence – is simply too terrifying.

Continue reading “Once Again, the FDA Admits it Lied to us. And Once More, we Yawn – Jonathan Cook 8/21/23”

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Have the Regulators Approved a Trojan Horse? – Julie Sladden and Julian Gillespie 8/16/23

Source: Brownstone.org

The alarming discovery by scientist Kevin McKernan, of DNA contamination in vials of Pfizer and Moderna Covid vaccines has raised significant concern in the scientific community. Meanwhile, the reported finding has attracted criticism from those quick to ‘demonise’ anyone questioning the safety, efficacy, and sanctity of the ‘vaccines.’ McKernan’s detractors – and there have been plenty of them – have criticised everything from lack of peer-reviewed publication to speculation about the viability of the anonymously sent vials.

Continue reading “Have the Regulators Approved a Trojan Horse? – Julie Sladden and Julian Gillespie 8/16/23”

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FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study – Megan Redshaw, J.D. 8/10/23

Source: TheEpochTimes.com

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and “bring new innovations and advances” to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.

Continue reading “FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study – Megan Redshaw, J.D. 8/10/23”

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Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer – Zachary Stieber 8/10/23

Source: TheEpochTimes.com

Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.

Continue reading “Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer – Zachary Stieber 8/10/23”

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Puppet Masters of the Pandemic. Part 2: What Did The CIA Do in Wuhan?” – Robert W. Malone MD 8/5/23

Source: rwmalonemd.substack.com

From Part I – the interview left of with the big question of who is the puppet master? What’s behind all this propaganda and control over the past three years? I spoke of different theories that people had put out there, and ended with the beginning of the hypothesis that the CIA may in fact be that controlling element. Part II picks up the thesis there.

Continue reading “Puppet Masters of the Pandemic. Part 2: What Did The CIA Do in Wuhan?” – Robert W. Malone MD 8/5/23″

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‘It’s Murder’: Remdesivir Victims Decry FDA’s Shocking New Move – Stella Paul 7/28/23

Source: AmericanThinker.com

Remdesivir may be the most despised drug in American history, earning the nickname Run Death Is Near for its lethal record during COVID.  Experts claimed that it would stop COVID; instead, it stopped kidney function, then blasted the liver and other organs.  Now this reviled destroyer of kidneys has been approved by the FDA for COVID treatment of kidney patients.  Does anybody else feel as if the FDA is shoving its power in our faces and laughing at us?

Continue reading “‘It’s Murder’: Remdesivir Victims Decry FDA’s Shocking New Move – Stella Paul 7/28/23”

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What’s in New Anthrax Vaccine? Aluminum, Formaldehyde and Benzethonium Chloride – Brenda Baletti, Ph.D. 7/24/23

Source: ChildrensHealthDefense.org

Emergent BioSolutions’ new anthrax vaccine contains dangerous toxins and may cause severe side effects, according to the product’s package insert.

The U.S. Food and Drug Administration (FDA), which approved the vaccine last week, posted the package insert late Friday.

“Is this a label or a cartoon?” asked Meryl Nass, M.D., a bioterrorism and anthrax expert who published an analysis of the insert on Substack. “You can’t make this stuff up,” she said.

Continue reading “What’s in New Anthrax Vaccine? Aluminum, Formaldehyde and Benzethonium Chloride – Brenda Baletti, Ph.D. 7/24/23”

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Solutions to Vaccine Troubles in Ten Sentences – Clayton J. Baker, MD 7/24/23

Source: Brownstone.org

The uncritical, blind faith in vaccines is the preeminent sacred cow of modern medicine. (It happens to be its preeminent cash cow as well.) It is a quasi-religious, dogmatic article of conviction, rather than a sound scientific theory or an empirically-based clinical precept.

Vaccines have been controversial since their introduction centuries ago. Only in very recent history has there been a rigidly enforced orthodoxy of belief within the medical establishment that vaccines must be unanimously regarded as “safe and effective,” no questions asked.

Continue reading “Solutions to Vaccine Troubles in Ten Sentences – Clayton J. Baker, MD 7/24/23”

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Clinical Trial Documents Suggest Moderna Skimped on Autopsies, Discounted Serious Injuries; Did FDA Know? – Children’s Health Defense 7/20/23

Source: ChildrensHealthDefense.org

A 13,685-page tranche of documents related to Moderna’s COVID-19 vaccine clinical trials released Tuesday contain details about the deaths of 16 trial participants, the prevalence of severe adverse events (SAEs) and other abnormalities.

Continue reading “Clinical Trial Documents Suggest Moderna Skimped on Autopsies, Discounted Serious Injuries; Did FDA Know? – Children’s Health Defense 7/20/23”

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WHO Plan to List Aspartame as ‘Possible Carcinogen’ Ignites Decades-Old Debate About Safety, and Donald Rumsfeld’s Role in FDA Approval – John-Michael Dumais 7/13/23

Source: ChildrensHealthDefense.org

News that the World Health Organization (WHO) on Friday is expected to classify aspartame as a “possible carcinogen” has reignited a debate that has churned since the U.S. Food and Drug Administration (FDA) first approved the artificial sweetener more than four decades ago.

Continue reading “WHO Plan to List Aspartame as ‘Possible Carcinogen’ Ignites Decades-Old Debate About Safety, and Donald Rumsfeld’s Role in FDA Approval – John-Michael Dumais 7/13/23”

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Kennedy’s Health Policy Roundtable – Dr. Joseph Mercola 7/8/23

Source: LewRockwell.com

June 27, 2023, Robert F. Kennedy Jr. held a Health Policy Roundtable featuring a panel of health freedom advocates, including yours truly; my good friend Dr. Patrick Gentempo; Maureen McDonnell, a holistic pediatric nurse; Dr. Pierre Kory, cofounder of the Frontline COVID Critical Care Alliance (FLCCC); filmmaker Mikki Willis; Sayer Ji, founder of Greenmed.com; and Dr. Sherri Tenpenny.

Continue reading “Kennedy’s Health Policy Roundtable – Dr. Joseph Mercola 7/8/23”

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How FDA Spins the Science on Cellphone Radiation and Human Health Risks – Suzanne Burdick, Ph.D. 7/7/23

Source: ChildrensHealthDefense.org

Editor’s note: This is the first in a three-part series examining key questions in the public debate on the safety of wireless radiation. Part I addresses the question, How did the FDA arrive at its position on cellphones and cancer?

Continue reading “How FDA Spins the Science on Cellphone Radiation and Human Health Risks – Suzanne Burdick, Ph.D. 7/7/23”

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mRNA COVID-19 Vaccines Should Be Labeled Gene Therapy Products: Peer-Reviewed Paper – Megan Redshaw, J.D 6/30/23

Source: TheEpochTimes.com

Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.

Continue reading “mRNA COVID-19 Vaccines Should Be Labeled Gene Therapy Products: Peer-Reviewed Paper – Megan Redshaw, J.D 6/30/23”

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Blockbuster Weight-Loss Drug Linked to Serious Kidney Issues – Dr. Joseph Mercola 6/14/23

Source: ChildrensHealthDefense.org

Story at a glance:

  • Semaglutide, the blockbuster drug being used for weight loss, is slated to bring in more than $10 billion in annual sales but serious adverse effects are emerging.
  • A study using data from Eudravigilance, Europe’s system for analyzing adverse reactions to medications, found a high prevalence of gastrointestinal disorders among users.
  • Other semaglutide patients “experienced rapid worsening of kidney function” after use.
  • Semaglutide has also been associated with cancer, pancreatitis and retinopathy complications, including hemorrhage and blindness.
  • Long-term use of GLP-1RAs like semaglutide may even leave your small intestine as inelastic as a loose spring, causing a potentially fatal intestinal obstruction.

Continue reading “Blockbuster Weight-Loss Drug Linked to Serious Kidney Issues – Dr. Joseph Mercola 6/14/23”

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Sucralose: Emerging Science Reveals Health Risks – Stacy Malkan 5/30/23

Source: usrtk.org

Sucralose is the most widely used artificial sweetener in the United States. Most commonly sold under the brand name Splenda, the chemical is used in over 6,000 food products. It is often found in “diet” sodas including Diet Coke with Splenda, Diet Pepsi with Splenda, as well as Gatorade’s Propel Water, low-calorie Kool-Aid, Atkins Diet products, and other low-calorie foods and drinks.

Sucralose is 600 times sweeter than sugar and itself contains no calories. Although it has been marketed as a healthy product that can help fend off obesity and diabetes, sucralose consumption has been linked to leukemia, weight gain, obesity, diabetes, liver inflammation, metabolic dysfunction and other illnesses.

Continue reading “Sucralose: Emerging Science Reveals Health Risks – Stacy Malkan 5/30/23”

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FDA Finds Evidence of Serious Safety Signal for COVID Vaccines in Young Kids; Says It Proves Shots Are ‘Safe’ – Children’s Health Defense 5/25/23

Source: ChildrensHealthDefense.org

Children ages 12 to 17 who received the mRNA COVID-19 vaccine face a heightened risk of heart inflammation, according to a new U.S. Food and Drug Administration (FDA) study.

Continue reading “FDA Finds Evidence of Serious Safety Signal for COVID Vaccines in Young Kids; Says It Proves Shots Are ‘Safe’ – Children’s Health Defense 5/25/23”

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New Evidence FDA, CDC Hid Early Data on Myocarditis Spurs Questions of ‘Criminal Coverup’ – Children’s Health Defense 5/23/23

Source: ChildrensHealthDefense.org

New evidence suggesting public health officials knew early in 2021 that COVID-19 vaccines posed a heightened risk of myocarditis in young men — but withheld that information from the public — raises questions about whether federal health agencies violated any laws.

Continue reading “New Evidence FDA, CDC Hid Early Data on Myocarditis Spurs Questions of ‘Criminal Coverup’ – Children’s Health Defense 5/23/23”

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FDA Approves First RSV Vaccine, But Some Experts Say Weak Safety, Efficacy Data Suggest Benefits Don’t Outweigh Risks – Children’s Health Defense 5/4/23

Source: ChildrensHealthDefense.org

Describing it as a “long-sought scientific achievement,” the U.S. Food and Drug Administration (FDA) on Wednesday approved Arexvy, the first vaccine for respiratory syncytial virus (RSV).

GlaxoSmithKline Biologicals (GSK) developed Arexvy under the FDA’s Priority Review designation. The FDA approved it for people ages 60 and older.

Continue reading “FDA Approves First RSV Vaccine, But Some Experts Say Weak Safety, Efficacy Data Suggest Benefits Don’t Outweigh Risks – Children’s Health Defense 5/4/23”

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US Food and Drug Administration Warns GMO Developers Over Food Allergy Risks – GM Watch 4/22/23

Source: GMWatch.org

The US Food and Drug Administration (FDA), which regulates genetically modified organisms (GMOs) for food safety, has written a letter to manufacturers and developers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food. The FDA cautions these developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks.

Continue reading “US Food and Drug Administration Warns GMO Developers Over Food Allergy Risks – GM Watch 4/22/23”

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Antiviral Monoclonal Antibodies Safe and Effective in Acute COVID-19 – Peter A. McCullough MD 4/6/23

Source: petermcculloughmd.substack.com

I would have never thought five years ago that I would be using advanced monoclonal antibodies to treat acute viremia in a potentially fatal illness to help a patient avoid hospitalization or death. Yet, early research done by Dr. Ralph Baric who conceived SARS-CoV-2 in his 2015 papers also anticipated the development of a countermeasures such monoclonal antibodies directed against SARS-CoV-2.

Continue reading “Antiviral Monoclonal Antibodies Safe and Effective in Acute COVID-19 – Peter A. McCullough MD 4/6/23”

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Executive Order Lays Foundation for Lab-Created Foods – Dr. Joseph Mercola 4/5/23

Source: LewRockwell.com

Dr. Mercola Interview Begins at 3:40 Video Link

September 12, 2022, U.S. President Joe Biden signed an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy.”1

This executive order makes biotechnology a national priority across agencies and branches of government. As noted in this order, biotechnology will also be used to “improve” food security, sustainability, and agricultural innovation in the U.S.:

Continue reading “Executive Order Lays Foundation for Lab-Created Foods – Dr. Joseph Mercola 4/5/23”

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‘Simply Obscene’: FDA Approves Fourth COVID Shot for Infants and Kids Under 5 – Children’s Health Defense 3/15/23

Source: ChildrensHealthDefense.org

Infants and children 6 months through age 4 who received the three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine are now eligible for a fourth dose — Pfizer’s bivalent booster shot.

The U.S. Food and Drug Administration (FDA) on Tuesday amended the Emergency Use Authorization (EUA) of Pfizer bivalent COVID-19 booster vaccine for the younger age group, but only for those children who received the three-dose series before the FDA authorized Pfizer’s bivalent Omicron booster as the third shot in the primary series.

Continue reading “‘Simply Obscene’: FDA Approves Fourth COVID Shot for Infants and Kids Under 5 – Children’s Health Defense 3/15/23”

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Lawsuits Pile Up Alleging Remdesivir Killed COVID Patients – Dr. Joseph Mercola 3/14/23

Source: ChildrensHealthDefense.org

Story at a glance:

  • The antiviral drug remdesivir, brand name Veklury, is approved for use against COVID-19 despite research showing it lacks effectiveness and can cause high rates of organ failure.
  • John Beaudoin is calling for a criminal investigation into remdesivir, citing data that it may have killed 100,000 people in the U.S.
  • Beaudoin received all the death certificates in Massachusetts from 2015 to 2022, finding 1,840 excess deaths from acute renal failure from Jan. 1, 2021, to Nov. 30, 2022, which he believes may be due to remdesivir.
  • A study published in The Lancet found “no clinical benefit” from the use of remdesivir in hospitalized patients.
  • The U.S. government pays hospitals a 20% upcharge on the entire hospital bill when remdesivir is used.

Continue reading “Lawsuits Pile Up Alleging Remdesivir Killed COVID Patients – Dr. Joseph Mercola 3/14/23”

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Court Documents Show GlaxoSmithKline Knew for 40 Years that Zantac Could Cause Cancer – Children’sHealthDefense 2/17/23

Source: ChildrensHealthDefense.org

Amid tens of thousands of lawsuits that are pending in state courts all across the U.S., a new report based on evidence discovered in these court cases reveals Big Pharma giant GlaxoSmithKline (GSK) had, for decades, concealed evidence showing that Zantac could cause cancer.

Continue reading “Court Documents Show GlaxoSmithKline Knew for 40 Years that Zantac Could Cause Cancer – Children’sHealthDefense 2/17/23”

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FDA Reveals Why It Changed End Date of Study of Heart Inflammation After COVID Vaccination – TheEpochTimes 2/14/23

Source: TheEpochTimes.com

The U.S. Food and Drug Administration (FDA) changed the end date of a study it is requiring Pfizer to conduct because Pfizer requested a delay, the agency says.

“The company requested an extension from FDA for completion, which the agency granted,” an FDA spokesperson told The Epoch Times via email.

Continue reading “FDA Reveals Why It Changed End Date of Study of Heart Inflammation After COVID Vaccination – TheEpochTimes 2/14/23”

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As FDA Prepares to Roll Out RSV, Flu Shots, Fauci Concedes they’re not Ready for Prime Time – DanielHorowitz 2/13/23

Source: ConservativeReview.com

Imagine not only having injected 5.5 billion people with multiple doses of the failed COVID shots, but destroying lives and denying humane treatment on account of them. Now imagine knowing everything we know about the efficacy and safety of these novel therapies and still forging ahead with more doses and now RSV and flu shots built upon the same platform. Bad enough, right? Well, it gets even worse. Fauci now concedes that all respiratory viral vaccines are garbage, including those for flu, coronavirus, and RSV. Yet the policies never match the new admissions, as they race to accelerate the new flu and RSV shots within months.

Continue reading “As FDA Prepares to Roll Out RSV, Flu Shots, Fauci Concedes they’re not Ready for Prime Time – DanielHorowitz 2/13/23”

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Top US Officials Discussed ‘Adverse Event Issue’ With COVID-19 Vaccines and Pregnancy – TheEpochTimes 2/11/23

Source: TheEpochTimes.com

Top U.S. health officials were concerned with an “adverse event issue” concerning COVID-19 vaccines being injected during pregnancy, according to newly disclosed emails.

On May 14, 2021, officials with the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) were exchanging emails about language concerning the co-administration of COVID-19 vaccines with other vaccines during pregnancy.

Continue reading “Top US Officials Discussed ‘Adverse Event Issue’ With COVID-19 Vaccines and Pregnancy – TheEpochTimes 2/11/23”

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Why Are Toxic Phthalates Still Used in Medical Supplies for Premature Babies? – Children’sHealthDefense 1/30/23

Source: ChildrensHealthDefense.org

Since the late 1960s research has shown that a plastic additive in polyvinyl chloride (PVC), leaches from medical devices and is toxic to multiple organs, especially for premature infants.

Despite more than two decades of evidence, advocacy and education around the issue, PVC products containing this harmful phthalate chemical still dominate the neonatal intensive care unit (NICU) environment.

Continue reading “Why Are Toxic Phthalates Still Used in Medical Supplies for Premature Babies? – Children’sHealthDefense 1/30/23”

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Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021 – JAMANetwork 1/13/23

Source: jamanetwork.com

Direct-to-consumer drug advertising increased by nearly 5-fold from 1997 to 2016, with 663 000 television commercials reported in 2016. Television advertisements account for roughly two-thirds of total direct-to-consumer advertising spending.1 Direct-to-consumer advertising is associated with use of higher-cost drugs over generics and less expensive alternatives.2 Proponents have argued that such advertising improves public health by promoting clinically beneficial prescribing. We assessed the therapeutic value (ie, whether they represent advances over existing treatments) of drugs subject to most direct-to-consumer television advertising from 2015 to 2021.

Continue reading “Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021 – JAMANetwork 1/13/23”

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Why Is The Vaccine Killing Our Young Men And Women? – AMidwesternDoctor 1/7/23

Source: AMidwesternDoctor.substack.com

A new study provides valuable clues about the toxicity of the spike protein.

Note: A detailed compilation of the epidemic of sudden deaths in our healthiest members of society can be found within Cause Unknown. Damar Hamlin was extremely fortunate to collapse where he did and medical care was immediately available, in almost any other setting as many of the examples within Cause Unknown show, he likely would have died (this has also been demonstrated for SIDS following vaccination).

I have long been interested in studying how pharmaceutical drugs injure people. Before COVID-19, while quite common, this issue was relatively unknown, because the media–which receives significant sponsorship from the pharmaceutical industry–was rarely willing to cover this subject. Because of my interest, I’ve focused on trying to understand how the COVID-19 vaccines injure people, such as causing sudden adult death syndrome.

Continue reading “Why Is The Vaccine Killing Our Young Men And Women? – AMidwesternDoctor 1/7/23”

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The Coming Grand Jury Indictments of 2023 and Beyond – Dr.JosephSansone 12/30/22

Source: josephsansone.substack.com

Elon Musk continues to release incriminating files from Twitter that shows criminal activity. Censoring citizens regarding Covid, Ukraine, and Covid 19 bioweapons, all at the behest of the government. Covering up sensitive political information regarding Hunter Biden’s laptop, and certainly, anything to do with fraudulent elections.

Recently, Elon Musk called out gain of function research, promoted by  Anthony Fauci, as a bioweapon. Musk is correct. Gain of function research is bioweapon development. Dr. Francis Boyle, an international and criminal law expert, has been pointing out for quite some time that Fauci and others are criminally implicated in the development of an offensive biological weapon in a scientific paper entitled,  A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence, published in 2015. Dr. Boyle, is also author of the 1989 Biological Weapons and Antiterrorism Act, and in his book,  Resisting Medical Tyranny, lays out a legal strategy of bypassing corrupt federal courts and seeking indictments in state courts. Statewide grand juries, utilizing state attorney generals, as well as grand juries utilizing state attorneys, and even county prosecutors where applicable, are part of this strategy. Indictments for murder and conspiracy to commit murder can be sought. Dr. Boyle asserts that once the first indictment comes in the house of cards will fall. This is also mentioned in my open letter to Attorney General Ashley Moody.

Continue reading “The Coming Grand Jury Indictments of 2023 and Beyond – Dr.JosephSansone 12/30/22”

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Shocking Lab Investigation of Covid Vaccines – Dr.JosephMercola 1/2/23

Source: LewRockwell.com

The Highwire posted1 a fascinating and shocking lab investigation of the COVID shots. Del Bigtree begins by reviewing some of the many alleged findings by organizations looking at the shots using various technologies. For example, some claim to have found graphite in the vials, while others have discovered what looks like nanotechnology and parasites.

Continue reading “Shocking Lab Investigation of Covid Vaccines – Dr.JosephMercola 1/2/23”