FDA

Mass School Shooting: A Mental Health Common Denominator

Posted on by Helena

Liberal anger has reached a pinnacle of insanity wherein a gun is now the cause of children being shot.   Ban all assault guns!   They demand.   But the AR15 is NOT an assault weapon.   Ban the AR15 anyway!   RAISE the age a person can legally buy a gun from 18 to 21!   But the vast majority of ALL school shootings are perpetrated by children under 18 or adults over 21.   Change the age anyway!     So let’s take a look at School Shootings:

While school shootings have been recorded since the mid 1800’s, causal factors have morphed from petty arguments to severe mental health issues.   Since 2000 there have been 369 school shootings.   Of those, 55 have occurred during Biden’s presidency.   Of the 369 shootings 14 classify as mass shooting in which 4 or more people died:

1) October 2002, Tucson Az – 40 year old failing college student killed 3 professors and himself. He was a Gulf war veteran suffering PTSD.

2)   March 2005, Minnesota – 16 year old Jeff Weise killed 10 including his grandfather with whom he was living after his father’s suicide. He was taking Prozac and was severely depressed having attempted suicide.

3)   October 2006, Pennsylvania – 32 year old truck driver killed 5 Amish girls and himself, wounding five additional girls.   His suicide note claimed he had raped two girls when he was 12 and wanted to rape again.

4)   April 2007, Virginia – Seung Hui-Cho was 23 when he killed 33 Virginia Tech students and wounded 23 more.   In middle school he had been diagnosed with severe anxiety disorder, severe depression disorder and mutism. He was diagnosed Autistic and Aspergers.

5)   February 2008, Illinois – Steven Kazmierczak, age 27 was treated for mental illness and sent to a psychiatric center while in high school. He regularly took Prozac, Xanax and Ambien.   He killed 6 and injured 21.

6)   April 2012, California – 43 year old One Goh killed 7 and wounded 3 at a Christian College. He was expelled from University for disciplinary issues and later diagnosed with Paranoid Schizophrenia.

Sandy Hook, Adam Lanza – brain development disorder, Schizophrenia, Asperger… taking Celexa. It is speculated that the Texas shooter, Ramos, was taking transition drugs.

Studying the factors of each mass shooting is essential to find the common denominators.   Then, a solution can be implemented. In this, it becomes evident that the common attributes have nothing to do with age or guns, and everything to do with mental disorders and prescription drugs!   Anti-depressants are associated with suicidal thoughts, hallucinations, insomnia, confusion, irritation, as well as a myriad of health problems.

If the liberals took a few minutes to actually research the issue, their rage and indignation might be redirected…   assuming they wanted to know the Truth. However, despite the prevalence of mental health issues, the US is slow to respond and more inclined to have individuals self diagnose and self medicate.   Insurance covers a handful of diagnoses ‘only after a two year waiting period’.

The CDC estimates that 75% of people with mental health issues do NOT seek treatment.   The vast majority of patients are given a prescription drug without treatment.   The side effects are so debilitating that being able to work can become unmanageable.   And the cycle of depression is actually enhanced. 33% of those taking medication report that it does nothing to improve their issues.

There are numerous alternative remedies that don’t have the side effects. Even Harvard has come full circle to recommend these safe and effective treatments.   But without a more hands-on approach, most people who suffer have been given absolutely no information to this regard.   As such they are left to search for themselves.

Alternative treatments used to be squelched because of the belief that the FDA is scrupulous in its trials and studies of pharma whereas herbs and remedies are not evaluated.   Given the vaccine fiasco that derailment is obviously without merit.   The FDA is lax and negligent.

In that light, schools, doctors, doctor offices, and companies could simply provide a free pamphlet that discusses various types of mental health issues and various over-the-counter herbs and roots that could benefit the person.   Certainly, this won’t eliminate the problem, but it would be far more productive than eliminating or sanctioning guns, knives, cars, hammers, axes, and other weapons.

Because as we are well aware – sanctions against people, countries, objects, and weapons has absolutely ZERO actionable consequences.

The two most relevant evidentiary factors of this today include:   Mass School Shootings, and Russia!

FDA Authorizes SARS-CoVid Drug

Posted on by Helena

Glaxo Smith Kline in conjunction with Vir Biotechnology funded by CEPI, Bill Gates, and The Wellcome Trust has been granted FDA authorization use for a monoclonal antibody drug administered via IV injection for SARS-Cov.   The drug is only in Phase 2 Trials, which included 868 patients, 63% of whom were Hispanic and 7% Black.   They did not provide the race of the remaining 30%.   The claim is that the drug is 85% effective in reducing hospitalization or death in those with mild to moderate SARS-Cov who are at high risk. They don’t define what makes someone ‘high risk’.    Is it because they are Hispanic?   Or is it because they are 85 years old?

Glaxo defines primary efficacy endpoint as “the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for greater than 24 hours for acute management of illness or death.”  Therefore if a person did not die, the drug was considered effective!

Given that the trials are scarce to none, potential adverse effects should be duly noted:

Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of Sotrovimab. These reactions may be severe or life threatening. Including: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia, chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions, dizziness and diaphoresis.

In addition, many of these reactions have been observed more than 24 hours after the injection requiring hospitalization.

The entire Phase 2 Trial time frame observed was 29 days.

The Wellcome Trust is chaired by Eliza Manningham Buller, a former intelligence officer with MI5. She was a teacher of English before being recruited to work for the UK Security Service specializing in counter-terrorism and espionage…   Interesting transition. The NGO nontaxable Wellcome Trust invests a portion of its 26billion Euro Endowment in Pharmaceutical companies that it supports financially – such as Glaxo Smith Kline.

The Conflict of Interest is so verbose it is astounding!

GSK has attested that further clinical trials for their experimental drug, Sotrovimab, will begin sometime during the second quarter of 2021 having only entered into the Vir Biotechnology collaboration this past April – 2 months ago.  In addition, there are caveats about who may receive the drug including anyone needing oxygen and possibly pregnant women…

If you thought the SARS-CoVid vaccine was using the global population as their Phase 4 Trial – Sotrovimab MRna has only passed Phase 2 and the FDA’s authorization is proof positive we are the Guinea Pigs for Phase 3!

COVID National Security & Emergency Status – Illegal?

Posted on by Helena

Legally, for the HHS to declare a State of Emergency they must determine there is a National Security Threat.   In order for that threat to be confirmed, there are multiple rules in place that assist in making the declaration.   Those rules would dictate that in order for a disease to be considered a viable cause for implementing the Emergency Order, it should be identified as a terrorist attack, a biological warfare attack that justifies it as a Security issue both at home and for American citizens abroad.

In addition, in order for the FDA to authorize unlicensed, unapproved treatment for a disease, there can NOT be any other available treatments.

Public Health Emergency Law:   A pre-requisite to determining the use of biological agents to treat a disease via the EUA – There can be no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.

In addition:   Within the emergency authorization, fact sheets providing the potential risks shall be provided to each patient who then has the ‘option’ to accept or refuse the product with no consequences! In addition, the FDA is mandated to provide patients with alternatives whether approved for use or not. State and local officials must comply with the conditions attached to the tests and treatments, ie refusing to comply shall have zero consequences.

NO tests or treatments shall be mandated given the entire purpose is to uphold economic and individual freedom and ALL measures will be deemed ‘GUIDANCE’ and shall not infringe on freedom.

Lockdowns and closures were – illegal.   We were not fighting an attack.   We were fighting a disease.  Diseases are NOT terrorists.

Humor!   In the wake of all the rules promoted by various states in converting our freedoms to illegal wakes, 2 democrat senators have determined 2 measures should be made law: 1. Third party delivery apps would have a cap on fees, and 2.   Restaurants would be allowed to sell ‘cocktails to go’ for two years.   Priorities!

These statements, rules and guidance I am quoting are stipulated within The Homeland Security Act, Public Health Emergency Medical Countermeasures, Public Health Service Act and the FDA.

The authority for treatment is specified as coming from government ‘stockpiles’ or from previously issued but unapproved treatments that meet risk evaluation vs benefit analysis, or from treatments approved for other diseases but not yet approved for this disease.   These treatments must continue to undergo rigorous trials and updates made available on a continual basis to the FDA in the form of reports.   These reports which must be made public via the FDA must include adverse reactions – as in keeping the public informed.  To the best of my knowledge none of these requirements have been met.

March 27, 2020, the Following Federal Declaration was issued by Azar, Secretary for HHS:

“…there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he (Azar, Sec of Health) also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.”

 According to the FD&C Act 564, the FDA must determine that: “If the secretary of the Department of Health and Human Services (HHS) determines that there is a public health emergency under the Public Health Service Act (PHS Act) §31910 that affects, or has significant potential to affect, national security and involves specified CBRN agents (chemical warfare) and diseases… an EUA can be allowed.

In other words, all these authorizations were dependent on the one thing the White House and Fauci continually denied!   A Terrorist Attack using chemical agents. As such, they acted outside their authority.

The Heritage Organization issued an essay in 2015 targeting misconceptions on the use of and definition of National Security. Identifying what it is NOT, Heritage issued this statement:   “While a pandemic disease could endanger the safety and security of thousands of Americans, unless it is committed as an act of biological terrorism, it should be considered a matter of health and domestic safety, not national security.”

Once again, the distinction is whether an event occurs as a direct result of an attack, or act of biological terrorism, or whether it is a ‘social security’.   Further undermining the entire federal, state and local misuse of power.   National Security is not climate change, it is not gender identity, it is not human rights.   And it is not disease. National Security involves a threat of war wherein the military is involved.  That has always been it’s purpose and interpretation.

As such, 1000 lawyers and 10,000 doctors have convened to file a lawsuit claiming the CoVid laws and lockdowns violated the Nürnberg Code against the CDC, WHO and Davos Group for crimes against humanity. Stating:

  1. The PCR test was never designed to detect pathogens and is 100% inaccurate at 35 cycles. All PCR tests monitored by the CDC are set at 37 to 45 cycles.
  2. Under Article 32 of the 1949 Geneva Convention, “mutilation and medical or scientific experiments not required for the medical treatment of a protected person” are prohibited.

However, the Nuremberg Code is based on the ‘Consequences of War’ – so the entire lawsuit may be tossed unless the National Security issue is triggered.  A very interesting conundrum!   Because governments declared a disease was a National Security Threat, they have in fact triggered the very concept of War – which would then trigger the Nuremberg Code.   If it is deemed to NOT fall into the category of war, then every aspect of lockdowns was ILLEGAL>

CoVid Tests: Bill Gates, Soros and NED Emerge! How Perfectly Perfect.

Posted on by Helena

While the focus continues to be on the vaccines, who, what and where they were manufactured, Test Cases still dominate the News.   So who is manufacturing the Test Kits that create these caseloads?  

There are five primary sources in the US: Access Bio, Hologic, Abbott, Roche and Quidel.

Access Bio:   Has created three tests; 1. MDX RT PCR – for the rapid detection of human coronavirus SARS COV2 viral RNA extracted via nasal aspirate – which claims it will detect all mutations and takes 83 minutes,   2.   lgM/lgG a blood test that identifies antibodies in 10 minutes, and 3. The Rapid POC Test which tests for nucleocapsid protein antigen, and must be administered by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Access Bio’s headquarters is in New Jersey and it works in affiliation with the Bill & Melinda Gates Foundation, the Global Good Fund, UNICEF, WHO, and Doctors Without Borders. Its specialty is the testing for Malaria. AH – surprise!   In 2017 they brought an asymptomatic malaria test to market.  Because it is important to determine if someone needs a vaccine even though they have absolutely no verifiable symptoms of disease…

The Global Good Fund partners include the Smithfield Foundation (as in Smithfield sold to China), The John Maxwell Company, GCH Partners, Global Partnership for Social Accountability, and Johnson & Johnson, among others.

The Global Partnership for Social Accountability (GPSA) has a large swathe of investors including;   Scytl, National Democratic Institute, Ford Foundation, Open Government Partnership and the Open Society Foundations. It’s steering committee consists of donor members including, Jonas Rolett who is special advisor to the Chairman, George Soros from the Open Society.   Well Dang Nabbit!

Gregory Mark Hill is the Managing Partner of GCH Partners.   Hill serves as the China liaison having spent many years in various company capacities in Beijing including:   V2V Ventures of Tsinghua Venture Capital, which is owned by the CCP. As in Communist China.

So we have a manufacturer of CoVid test kits used in the US and UK which are funded by Bill & Melinda Gates in partnership with various organizations that include Soros, China – CCP, Scytl, a voting tabulation company that has been charged with manipulating the US Presidential Election, and the National Democratic Institute which is funded by the Orange Revolution cult, National Endowment for Democracy!

I think I’ll pass on those test kits!

Another company;  Hologic was given permission by the FDA for emergency use of CoVid 19 test kits.   In November 2020, Hologic won a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, Wisconsin, Maine and California, with the goal to provide 13 million COVID tests per month by January 2022.   2022????

The obvious question would be why would we need tests in 2022?

They offer two different tests both of which are built to detect RNA and are ‘so sensitive’ they can detect SARS in asymptomatic as well as symptomatic individuals.   According to their package insert, they make this unusual statement:   “Positive results do not rule out bacterial infection or co-infection with other viruses.” In addition, a negative result does not mean you are truly negative.

While the tests have been cleared by the FDA under emergency use, they have not been approved. The insert, which is 34 pages, defines the proper means, use, and requirement that a health professional certified in providing these tests must be utilized.

And then there is this nugget:   Hologic Global Access Initiative is a global partnership with the Clinton Health Initiative and MedAccess backed by the UK Government to provide low cost HIV testing for Africa.

Would you touch a Clinton CoVid test?

QUIDEL:   The insert for the Quidel CoVid test makes an interesting acknowledgement: There are no ‘approved’ tests by the FDA. These tests are simply ‘available’ under emergency use.

Roche makes the statement that their CoVid test actually makes an assay of the entire subgenus family which would include ALL Coronaviruses – meaning a positive result could indicate you have antibodies for SARS, MERS, or a Cold.

All these tests are based on a best-guess-estimate of science that would seem to have not been ‘approved’ by any government organization or tested by any independent organization under a large sample of volunteers.   Yet, that would encapsulate every single CoVid Test manufactured everywhere…

There are two basic forms of tests: Molecular and Antigen.  

Molecular diagnostics are individually dependent upon a person’s genomes via strands of DNA. Assays are simply markers used to detect ‘the flu’ and have not been thoroughly studied and researched in specific types of ‘flu’, therefore their reliability is nonspecific.

According to the CDC, Antigen tests are commonly used in the diagnosis of “respiratory pathogens, including influenza viruses and respiratory syncytial virus”.  Antigen tests are best used when the viral load is at its height and it is already known the patient has been exposed, or if the patient has already had the virus and antibodies are still active.

Therefore, a physician’s determination is not just based on the test result, but on external theory.   For example: if a patient has already been exposed to a virus and is having symptoms, the antigen test could confirm the external evaluation.

While the CDC claims that antigen tests must comply with Clinical Laboratory Improvement Amendments (CLIA) regulations.   Those regulations have been ‘waived’ for ALL CoVid testing.

We have essentially handed our livelihoods to Big Pharma – sometimes in collaboration with the same organizations that produce the vaccines for the disease they are testing whether it be Malaria, HIV or Flu; ie Bill Gates.

If manufacturers are being told to ramp up testing for future development years in advance, that would indicate they anticipate the vaccine will either be worthless, or become a commonly required jab, not unlike H1N1 which has been whirled into the witches brew as an annual flu shot for 8+ years.

TESTING is virtually meaningless in the True Scientific genre of philosophy and medicine.   It negates the individual DNA/RNA and supercedes it with a global version that is simply NOT possible.   That would be like saying our genes are all the same – our immunity is all the same – our DNA is all the same. In which case, sampling a person’s DNA to determine if they were responsible for a particular crime – would encapsulate every person on the planet!  AH!

CoVid Vaccine? A Possible Hoax For Quick Money

Posted on by Helena

IS Moderna making a vaccine – or is it a hoax?  

Moderna is a relatively new biomedical company formed in September 2009 and going public in 2018 with a valuation estimated to be roughly $7.5 billion and cumulative losses of $1.5 billion.   Since its inception it has never made a profit.

While Moderna has conducted a few trials with large pharma collaboratives including Astra-Zeneca and Alexion, none of those trials have ever been successful.

Moderna moved to lower class vaccine development in 2014 and analysts predicted their demise.   As a result, Rossi, the founding biologist, left the company.

Shifting platforms, Moderna altered their focus and the technology platform instituted was a focus on mRNA Vaccines wherein synthetic mRNA would be inserted into living cells that would reprogram the cells to develop immune responses.  It is a novel technique abandoned by several large pharmaceutical and biotechnology companies due to their inability to overcome the severe side effects associated with the procedure methodology.

As of May 2020, no mRNA drug has been approved for human use. However this is the technique being employed in Moderna’s ‘supposed’ trials for a CoVid vaccine.   The likelihood of fast tracking a methodology that has failed for the past 40 years in trials is seemingly ludicrous – at best.

So what is Moderna really doing?

In 2010, Rossi, the initial creator of Moderna brought in Flagship Pioneering as a co-investor. Flagships CEO, Noubar Afeyan brought in a new Moderna CEO, Stephane Bancel who is known as a well-groomed stock manipulation player.

Moderna claimed to begin making its CoVid vaccine in January 2020 well before the virus was determined to be of pandemic proportions.  Setting the stage as the pre-emptive player, Bancel parlayed some very special sales pitch skills into a lucrative contract with NIAID despite a track record of – nothing but failures.

Since March 2020, key executives have been selling off their shares massively while reaping incredible profits from the CoVid hype according to SEC documents.   In February the stock was selling for around $18 per share, by July it had reached $87 despite having no assets other than cash.

Bancel and key executives have become billionaires in six months.  And yet, their key product fast tracked for delivery is a method that has proven unsuccessful due to severe reactions.

So far, Moderna claims to have conducted successful trials on monkeys and 45 humans – although serious side effects did occur such as delirium, high fever, chills, muscle pain, headaches and nausea – some causing hospitalization, Dr. Lisa Jackson of Kaiser’s Health Research Institute in Seattle (also connected with CDC and NIH), claims that is considered success!

The vaccine deposits the virus directly into a person’s cells with a 3-prong needle which supposedly causes the cells to fight the virus and produce antibodies.   Of the 45 human trials all were young, fit, and healthy – 20% reported ‘severe side effects typical for previous attempts to create an mRNA vaccine for SARS, 80% reported side effects.

Since March, key executives have sold off massive shares of their holdings while the general public is hyped by a delirious trial.

As such the FDA gave permission for Bancel to conduct testing on 30,000 humans in conjunction with NIH. What?

Various lawyers are calling for a criminal investigation.

In a clinical study conducted by NIH in February 2020, mRNA responses could include:

  1. Medically adverse effects that could occur after the original singular vaccine for up to a year.
  2. New onset chronic diseases that could occur after the vaccine up to a year post.
  3. Serious adverse effects that could take a year to show
  4. In the event that the virus mutates, mRNA could cause serious events that would be more dangerous than the original virus.

Other pharma companies enlisted in the CoVid vaccine marathon include Astra Zeneca which has also gone on to phase 3 of Trials despite 60% or more of subjects experiencing severe side effects sometimes not until 1 month after the vaccination. While Astra-Zeneca’s vaccine also includes T-cell responses, new studies have shown that antibodies can disappear within 3 weeks and T-cell responses within a few years thus requiring a constant load of boosters.

That means a vaccine will only protect a person for a few weeks… thus Bill Gates has stated that multiple vaccinations will be required per person. Based on the antibody approach that would mean a vaccine once per month? I doubt any trial will utilize this massive regimen in evaluating side effects. Brazil, South Africa, UK and the US are the point target for subject volunteers…

Most of the Pharma companies producing a vaccine will require a no liability clause in the event anyone contracts any debilitating side effects.

Recently, articles abound claiming a Fauci/Gates collaboration thru patents. In 2018 Fauci was granted a patent for a method of contacting a cell, specifically a T-cell, with an effective amount of an agent to reduce infection – specifically HIV. While Fauci and others are deemed the inventors, the assignee is the US Department of Health.  In fact, NIH or the Department of Health hold all the patents invented by their employees.

In 2015, Dr. Jeff Bradstreet was ‘suicided’ for his own discovery of an injectable protein binding substance that occurs naturally in every human – albeit those with immune deficiencies lack this protein – McGAF. He had success in treating cancer, HIV, and other diseases with this protein agent.   The fact that it occurs naturally in the human body made it ‘unpatentable’.   All his work and vials were confiscated by the FDA…

Could Fauci’s patent be a regurgitation of work confiscated from Bradstreet?

According to RFK, Jr., NIAID, of which Fauci is head, will receive 50% royalty rights to any vaccine given the cell factor per the patents.  However, again it should be noted that this methodology has NEVER been used on humans due to it failing clinical trials since 1980!

While Bill Gates does not personally hold any pharma shares, buying and selling thru a vast menagerie of holding companies is more typical and certainly opaque.   It is likely any shares he sold would have been short-term like the Moderna executives.   A fast buck.

However, instead he is busily building the facilities that will produce the vaccines – nine in total. No matter who wins the race, Gates will own the means.

And That’s How It Is Done.