Category: F.D.A.

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The FDA’s War Against Sleep – A Midwestern Doctor 8/22/24

Source: MidwesternDoctor.com

Story at a Glance:

  • The Power of Sleep: Proper sleep is essential for our health, and disruptions can lead to severe issues like heart attacks, psychiatric illnesses, car accidents, fatigue, diabetes, cognitive impairment, and dementia.
  • A Widespread Epidemic: Poor sleep affects many due to a lack of understanding about its importance and the use of sedative sleeping pills that hinder healthy sleep. For instance, medical training often deprives students of sleep, despite its critical role in learning.
  • The Forgotten Miracle Drug: In 1964, a remarkably effective sleeping medication hit the market, improving conditions like insomnia and overall health. However, its success threatened other drug markets. By 1990, the FDA and media launched a campaign against it, much like the case with ivermectin, resulting in the drug becoming almost unknown and many sleep disorders remaining untreated.
  • What You’ll Learn: This abridged article delves into the harms of poor sleep, explores common causes, and uncovers effective treatments for sleeping disorders….

Read More…

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Parents Now Allowed to Give Kids Nasal Flu Vaccine at Home, Despite Vaccine’s Link to Severe Reactions – Michael Nevradakis, Ph.D. 9/23/24

Source: ChildrensHealthDefense.org

Parents can now give their children ages 2 and up — at home — a nasal flu vaccine that the U.S. Food and Drug Administration (FDA) withdrew in 2016 because it was ineffective, and which has been associated with reports of children’s deaths, according to the Vaccine Adverse Event Reporting System (VAERS).

Continue reading “Parents Now Allowed to Give Kids Nasal Flu Vaccine at Home, Despite Vaccine’s Link to Severe Reactions – Michael Nevradakis, Ph.D. 9/23/24”

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FDA Approves Vaccine for Mpox; Warns It May Cause Death in Vaccinated and People They Come in Contact With – Suzanne Burdick, Ph.D. 9/17/24

Source: ChildrensHealthDefense.org

A vaccine approved in August by the U.S. Food and Drug Administration (FDA) for people deemed to be at “high risk” for mpox infection may cause more harm than good, according to the FDA’s own medication guide for the product.

Continue reading “FDA Approves Vaccine for Mpox; Warns It May Cause Death in Vaccinated and People They Come in Contact With – Suzanne Burdick, Ph.D. 9/17/24”

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Stomach Acid Is Critical For Health – A Midwestern Doctor 8/18/24

Source: MidwesternDoctor.com

Story at a Glance

•Many pharmaceuticals on the market are automatically given to large numbers of patients despite the harms of these medications often greatly outweighing their benefits.

•One of the worst offenders are the acid suppressing medications, and their overprescription goes hand in hand with widespread medical blindness to the critical functions of hydrochloric acid throughout the body, the symptoms of low stomach acidity (e.g., many autoimmune disorders), and the actual causes of acid reflux.

•Since the stomach needs to be able to let food in but stay closed while digesting it, its opening (the LES) is pH sensitive and will close when sufficient acid is detected. Because of this, reflux is frequently due to insufficient stomach acid (the production of which declines with age) which causes the remaining acid to leak out into the esophagus. Treating reflux by eliminating all acid causes the LES to stay open, and as a result, hooks patients on the drugs since the moment any acid comes back, it will leak out and cause heartburn.

•A chronic small leak of stomach acid can create many different issues in the ears, nose, and throat (e.g., allergies, coughs, and sinusitis).

•A variety of safe and non-invasive approaches exist to address the wide range of complications from acid reflux and dysfunctional stomach acid production.

Continue reading “Stomach Acid Is Critical For Health – A Midwestern Doctor 8/18/24”

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Former FDA Chief Details Fraud in Merck’s Testing, Marketing of Mumps Vaccine – Brenda Baletti, Ph.D. 7/16/24

Source: ChildrensHealthDefense.org

For decades, Merck misrepresented the efficacy of its mumps vaccine, marketing an “adulterated” drug without proven efficacy to millions of American children, according to a recently released expert report by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA).

Continue reading “Former FDA Chief Details Fraud in Merck’s Testing, Marketing of Mumps Vaccine – Brenda Baletti, Ph.D. 7/16/24”

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Infant RSV Shots May Cause RSV, Other Infections or Death in Some Babies, Study Finds – Brenda Baletti, Ph.D. 7/11/24

Source: ChildrensHealthDefense.org

The results from the first immunization campaign for nirsevimab, the monoclonal antibody shot approved to protect infants from RSV-related illness, raise questions about mass infant vaccination with the drug, according to a new preprint study.

The study by French scientist Hélène Banoun, Ph.D., which analyzed outcomes from the 2023-2024 respiratory syncytial virus (RSV) immunization campaign in the U.S., France, Spain and Luxembourg, contradicts some claims of success by U.S. public health agencies and medical associations.

Continue reading “Infant RSV Shots May Cause RSV, Other Infections or Death in Some Babies, Study Finds – Brenda Baletti, Ph.D. 7/11/24”

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White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates – Brenda Baletti, Ph.D. 6/28/24

Source: ChildrensHealthDefense.org

The Biden administration pressured the U.S. Food and Drug Administration (FDA) to “change its procedures, cut corners, and lower agency standards,” to approve Pfizer’s COVID-19 vaccines and authorize boosters, according to a congressional report released earlier this week.

Continue reading “White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates – Brenda Baletti, Ph.D. 6/28/24”

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Medical Elites’ Disgrace Over Ivermectin – David Gortler 5/11/24

Source: Brownstone.org

In the wake of the FDA settling a lawsuit brought against it for wantonly and aggressively smearing ivermectin, the agency has deleted its postings. That’s good, but we shouldn’t forget how egregiously it mischaracterized the drug, ignored copious evidence in its favor, and portrayed its proponents as dangerous crackpots.

Continue reading “Medical Elites’ Disgrace Over Ivermectin – David Gortler 5/11/24”

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Moderna Developing mRNA Vaccines for Diseases Linked to COVID Shots – John-Michael Dumais 4/2/24

Source: ChildrensHealthDefense.org

During its Vaccines Day Event for investors on March 28, Moderna announced progress on multiple mRNA-based vaccines and therapeutic candidates in its “pipeline.”

Three vaccines targeting Epstein-Barr virus (EBV), Varicella-zoster virus (VZV, chickenpox and shingles) and Norovirus are advancing to “pivotal late-stage development,” the company said.

Continue reading “Moderna Developing mRNA Vaccines for Diseases Linked to COVID Shots – John-Michael Dumais 4/2/24”

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Groups Sue FDA Over Livestock Drug Banned or Restricted in 160 Countries – Suzanne Burdick, Ph.D. 4/1/24

Source: ChildrensHealthDefense.org

Food safety, environmental and animal rights groups last week sued the U.S. Food and Drug Administration (FDA) in federal court in a bid to force the agency to ban or reduce the allowable levels of a widely used livestock growth drug that the groups said causes harm to humans, animals and the environment.

Ractopamine — banned or restricted in about 160 countries — is used by U.S. industrial livestock producers to rapidly grow muscle in cows, pigs and turkeys.

Continue reading “Groups Sue FDA Over Livestock Drug Banned or Restricted in 160 Countries – Suzanne Burdick, Ph.D. 4/1/24”

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FDA Will Remove Anti-ivermectin Social Media, Website Posts Under Lawsuit Settlement Agreement – Brenda Baletti, Ph.D. 3/22/24

Source: ChildrensHealthDefense.org

The U.S. Food and Drug Administration (FDA) agreed to take down its website and social media posts warning people not to use ivermectin to treat COVID-19 under terms of a settlement reached Thursday in a lawsuit alleging the agency exceeded its authority when it directed health professionals and patients not to use the drug.

Continue reading “FDA Will Remove Anti-ivermectin Social Media, Website Posts Under Lawsuit Settlement Agreement – Brenda Baletti, Ph.D. 3/22/24”

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RSV Vaccines Aren’t Even a Year Old but Some Experts Say It’s Time to Pull Them From the Market – Michael Nevradakis, Ph.D. 3/5/24

Source: ChildrensHealthDefense.org

It’s been less than a year since the Centers for Disease Control and Prevention (CDC) recommended two new respiratory syncytial virus (RSV) vaccines — yet CDC data and the Vaccine Adverse Event Reporting System (VAERS) already show reports of 34 deaths, 302 serious adverse events and according to news reports this week, a safety signal for Guillain-Barré syndrome (GBS).

Continue reading “RSV Vaccines Aren’t Even a Year Old but Some Experts Say It’s Time to Pull Them From the Market – Michael Nevradakis, Ph.D. 3/5/24”

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FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies – Suzanne Burdick, Ph.D. 1/30/24

Source: ChildrensHealthDefense.org

Clinical researchers no longer have to obtain informed consent from human subjects when their research poses “no more than minimal risk,” the U.S. Food and Drug Administration (FDA) ruled last week.

Continue reading “FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies – Suzanne Burdick, Ph.D. 1/30/24”

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The Decades of Evidence That SSRI Antidepressants Cause Mass Shootings – A Midwestern Doctor 11/4/23

Source: MidwesternDoctor.com

Story at a Glance:

•SSRI antidepressants have a variety of horrendous side effects. These include sometimes causing the individual to become agitated, feeling they can’t be in their skin, turning psychotic, and occasionally becoming violently psychotic.

•During these psychoses, individuals can have out of body experiences where they commit lethal violence either to themselves or others.

•As lawsuits later showed, this violent behavior (and the frequent suicides that followed it) were observed throughout the SSRI clinical trials, but were covered up by the SSRI manufacturers and then the drug regulators (e.g., the FDA).

•Once the SSRIs entered the market, there has been a wave of SSRI suicides and unspeakable acts of violence.

•Sadly, the idea that SSRIs could cause any of this has always been viewed as a “conspiracy theory” or “mistaking correlation with causation” because very few are aware of the extensive evidence linking SSRIs to violent and psychotic behavior—despite it now being on the warning label of those drugs.

Continue reading “The Decades of Evidence That SSRI Antidepressants Cause Mass Shootings – A Midwestern Doctor 11/4/23”

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How Far Will the Government Go to Cover Up Vaccine Injuries? – Dr. Joseph Mercola 12/6/23

Source: ChildrensHealthDefense.org

The U.S. government and Big Pharma have long suppressed evidence and dissent regarding unsafe, rushed vaccines, covering up injuries and disasters to maintain profits and vaccination programs. But social media is raising public awareness of vaccine injuries — and that may finally force accountability.

Continue reading “How Far Will the Government Go to Cover Up Vaccine Injuries? – Dr. Joseph Mercola 12/6/23”

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Owner Of Chinese Biolab Busted In California Linked To CCP Military Program: House Report – ZeroHedge 11/16/23

Source: ZeroHedge.com

The Chinese owner of a makeshift biolab discovered in a remote California city has ties to the People’s Republic of China (PRC) and a Chinese military program, according to a report by the House Select Subcommittee on the CCP.

Continue reading “Owner Of Chinese Biolab Busted In California Linked To CCP Military Program: House Report – ZeroHedge 11/16/23”

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DNA Integration Risk: Moderna Knows, FDA Denies – Robert W. Malone MD 11/10/23

Source: rwmalonemd.substack.com

Both Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes. This proven fact has been acknowledged by the US FDA, Health Canada, and the European Medicines Agency. In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients. Furthermore, the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies. This has also been clearly established. Prior FDA guidance concerning the closely related DNA vaccine technology cited the presence of such highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).

Continue reading “DNA Integration Risk: Moderna Knows, FDA Denies – Robert W. Malone MD 11/10/23”

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SARS-CoV-2 Variant HV.1; Obsolete Boosters – Robert W Malone MD 11/4/23

Source: rwmalonemd.substack.com

As previously covered (here), the currently available FDA emergency use authorized “booster vaccines” were designed based on recommendations developed at the FDA VRPBAC (vaccine and related products biological advisory committee), which predicted that the dominant SARS-CoV-2 variant this fall would be the “Kraken” (XBB.1.5) viral variant of Omicron.

To re-cap, the FDA and it’s advisory committee are operating based on the hypothesis that the dominant mechanism of protection against SARS-CoV-2 infection, spread, and COVID-19 disease afforded by vaccination or natural immunity involves “neutralizing antibodies”. This hypothesis is unproven, and no immunologic “correlate of protection” which predicts protection from either infection or disease has been clinically proven. To the extent that high levels of human “neutralizing antibodies” from the SARS-CoV-2 genetic “vaccines” provide any protection, they seem to “correlate” to reduced disease severity for some period after dosing, but do not prevent infection, replication, spread, disease or death.

Continue reading “SARS-CoV-2 Variant HV.1; Obsolete Boosters – Robert W Malone MD 11/4/23”

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FDA Responds After Being Urged to Recall Pfizer’s Vaccine Over DNA Fragments – Zachary Stieber 10/31/23

Source: TheEpochTimes.com

Dr. Robert Malone and other experts say the COVID-19 shot should be recalled.

The U.S. Food and Drug Administration (FDA) is refusing to recall the Pfizer-BioNTech COVID-19 vaccine, promoting the view that the inclusion of a previously-undisclosed DNA sequence that leaves behind fragments is not of concern.

Continue reading “FDA Responds After Being Urged to Recall Pfizer’s Vaccine Over DNA Fragments – Zachary Stieber 10/31/23”

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The FDA’s Ties to the Gates Foundation – Maryanne Demasi 10/20/23

Source: Brownstone.org

In 2017, the US Food and Drug Administration (FDA) entered into a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation.

Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,” such as diagnostics, vaccines, and therapeutics to combat disease transmission during a pandemic.

Continue reading “The FDA’s Ties to the Gates Foundation – Maryanne Demasi 10/20/23”

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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”