ICAN Placebo FOIA

ICAN Placebo FOIA

ICAN Placebo FOIA

Re: the data & proof of placebo control studies during vaccine clinical trials

 

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Facts of the Case

  • Dates: (filed) Oct 12, 2017
  • Location: New York, USA
  • Court: U.S. District Court for the Southern District of New York
  • Case #:
  • Plaintiff: ICAN
  • Plaintiff’s Lawyer: Robert F. Kennedy, Jr.
  • Defendant: HHS, FDA
  • Trial Type: FOIA
  • Judge:
  • Status: Decided
  • Verdict: for the Plaintiff


*updated: April 16, 2022

 

Background

The Department of Health and Human Services (HHS) was sent a 19-page legal notice on October 12, 2017 by the Informed Consent Action Network (ICAN) requesting confirmation that certain obligations regarding vaccine safety required under the 1986 Act had been fulfilled or will be fulfilled. [1]

Specifically at issue is the use of placebo’s (inert substances) during clinical safety trials

The notice asked (HHS) to “[p]lease explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?” [3]

ICAN sought copies of the reports HHS was required to submit to Congress every two years, starting in 1988, detailing improvements it made to vaccine safety. ICAN was represented by Robert F. Kennedy, Jr. [2]

ICAN was founded by Del Bigtree who hosts the weekly live online news program “The HighWire,” and is an Emmy-award winning producer of the CBS medical talk show “The Doctors.” He is producer of the groundbreaking documentary “Vaxxed: From Coverup to Catastrophe.” [2]

“The 1986 National Childhood Vaccination Injury Act granted economic immunity to pharmaceutical companies for vaccine injuries and hence eviscerated their economic incentive for them to take responsibility for vaccine safety,” says Bigtree. “Market forces driving vaccine safety were simply eliminated.” [2]

Congress therefore charged the Secretary of HHS with the explicit responsibility to assure vaccine safety. Biannual reports of HHS’s progress in improving vaccine safety were to be submitted to Congress. Yet, as ICAN has now proven, these reports were never created. [2]

The request included over 55 organizations whose members exceed five million Americans also voicing concern about vaccine safety. Freedom of Information Act (FOIA) documents show that the agency took the notice very seriously calling upon all internal departments and resources to craft their response. According to the FOIA documents, all HHS operating divisions, The National Vaccine Program Office, Assistant Secretary for Financial Resources, and The Office of the Assistant Secretary of Health all took part in the response. In Addition, FOIA email documents also state, “The National Vaccine Program Office staff has pulled together a draft response and is requesting that it be cleared with CDC, OGC, FDA, HRSA, NIH, and AHRQ for review prior to signature.”  [1]

Despite nine different government entities working on the response, their eventual January 18, 2018 reply was both lackluster and telling. Their brief 9-page response was unable to provide solid answers to the eleven questions asked of the agency concerning vaccine safety. The flimsily HHS reply triggered a deeply thorough 88-page response from ICAN laying out every detail concerning the problems and issues happening in regards to vaccine safety stemming from HHS. Its opening page writes: [1]

Given the gravity of HHS’s responsibility, it is deeply troubling that the majority of HHS’s letter contains little more than broad unsupported conclusory assertions. Most of these conclusory assertions do not withstand basic scrutiny. HHS’s responses even often contradict its own source materials.”  [1]

Among several concerning points, HHS choose to began their January reply by writing, “…many pediatric vaccines have been investigated in clinical trials that included a placebo.” [1]

As defined by the CDC, a “placebo” is: “A substance or treatment that has no effect on human beings.” [1]

HHS’s response also claimed that safety in these trials was reviewed for a significant duration, without specifying any duration. [3]

Recently on his show The HighWire, host Del Bigtree began publicly unpacking ICAN’s 88-page response by focusing on pre-licensure vaccine safety trials. The HHS reply contradicted itself by first admitting,

Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required. In some cases, inclusion of placebo control groups is considered unethical.

Later in their same letter, HHS states, “Vaccines are held to strict standards of safety.” [1]

Bigtree stated: “They’ve now printed it. So now you know for a fact that they just admitted those products you’re injecting into your kids have never been compared to a control. An inert saline injection.”​ [1]

Furthermore, according to HHS’s childhood vaccine schedule, babies receive 3 injections of each of the following vaccines between day one and 6 months of life all untested against a placebo control. [1]

 

 

Even pro-vaccine luminaries like Dr. Stanley Plotkin, vaccine authority and author of Plotkin’s Vaccines, appears to be in agreement with ICAN. Emails from a recent FOIA request show Plotkin wrote in June 2018 correspondence, “One point I do agree with [Robert F] Kennedy [Jr] about: there should be more safety studies…”​ [1]

 

 

Significance

Vaccine manufacturers insist that their products are safe and effective, despite many in the public reporting otherwise (injuries). Control experiments are essential to understanding how a medical product performs. Until this FOIA request, there has not been a public disclosure of this information casting doubt as to the “Science” underpinning the safe and effective claim. This information could harm the faith in one or all vaccines, and could be potentially destructive to this industry.

 

Plaintiff’s Argument

Given the conflicting information coming from HHS, ICAN’s 88-page response pressured their assertions writing: [1]

It is troubling that HHS chose to begin its response by misstating that prior to licensure for children “ many pediatric vaccines have been investigated in clinical trials that included a placebo.” At worst, HHS knowingly perpetuated this inaccurate claim but at best, HHS was unaware this claim was incorrect. This leaves the public to wonder what other critical assumptions underpinning HHS’s confidence in vaccine safety are incorrect.” [1]

ICAN’s original HHS notice directly pointed to concerns about the two Hepatitis B vaccines licensed for injection into one-day-old babies. Namely that the vaccines, according to the FDA’s own vaccine insert included in the original HHS notice, show that not only were the shots not tested against inert placebos, both vaccines were licensed after trials that solicited adverse reactions for only four days [Merck] and five days [GlaxoSmithKline] respectively after vaccination. To this point, HHS responded by referring back to the same inserts which contained the concerning data by simply writing, “Data relied upon in licensing infant use of hepatitis B vaccines is summarized in the respective package inserts.” [1]

ICAN’s response included a detailed chart containing every pediatric vaccine, citing to FDA documents, which indisputably proves that it was categorically false for HHS and the FDA to claim that “many pediatric vaccines have been investigated in clinical trials that included a placebo.” [3]

Perhaps one of the most damning findings referred to in ICAN’s 88-page HHS letter was titled HHS’s “Safety” Pyramid Scheme. Since inert placebo controls are not required and rarely used in vaccine safety testing, other vaccines take that role in what are referred to as “active controls.”  ICAN’s 88-page response to HHS points out to the agency the following: [1]

HHS’s own industry guidance for drug testing explains that an active control is only appropriate if it is a “drug whose effect is well-defined,” which means “historical placebo-controlled trials are available to define the active control effect.” Despite its own policy and guidance, HHS does not require this minimal assurance for vaccines.” [1]

 

 

 [SOURCE] Page 14 ICAN Response December 31, 2018

[SOURCE] Page 14 ICAN Response December 31, 2018

 

Defendant’s Argument

…More information is needed…

 

Decision

The US Department of Health and Human Services (HHS) settled a court-ordered stipulation  admitting that they could not produce 30 years of required evidence showing they have made improvements in the manufacturing, testing, warning, field surveillance, adverse reaction reporting and research on vaccines in order to reduce the risk of adverse reactions as mandated by the 1986 National Childhood Vaccine Injury Act (1986 Act). [1]

LOS ANGELES, Sept. 14, 2018 /PRNewswire/ — The U.S. Department of Health and Human Services (HHS) has admitted that, in direct violation of Federal law, it failed to provide a single vaccine safety report to Congress for thirty years, according to Informed Consent Action Network (ICAN).

HHS conceded that those reports do not exist and the Court entered an order confirming this concession. [2]

 

Aftermath

ICAN’s response:

“It is apparent that HHS doesn’t have a clue as to the actual safety profile of the now 39 doses, and growing, of vaccines given by one year of age, including in utero,” said Bigtree. “In 1986, a one-year old child received eleven doses. [2]

“HHS spends billions annually promoting vaccines and generates a steady stream of reports promoting vaccines,” Bigtree says. “Yet, when, despite Federal law, HHS cannot bother to complete the simple task of preparing a biennial report on vaccine safety, there is little hope HHS is tackling the much harder job of improving vaccine safety.” [2]

The 1986 Act shifted financial liability for vaccine injuries to the U.S. Government which has since 1986 paid over $3.9 billion for serious vaccine injuries. [2]

The reality is that none – save one – of the pediatric vaccines was licensed based on a placebo controlled clinical trial! … No proof has ever been provided. [3]

 
Further ICAN Lawsuits
  • ICAN also sued the FDA numerous times to force it to release clinical trial reports for other vaccines, including, for example, the chicken pox vaccine, which we explained in another recent legal update.
  • when the Phase III trial for AstraZeneca and the University of Oxford’s COVID-19 vaccine was underway in England using another vaccine (Menveo) as a control (instead of a placebo), ICAN filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control as well as track safety long-term in a properly sized trial.

Nine days after ICAN filed its petition, on June 30, 2020, the FDA changed course and issued emergency guidance to industry that all COVID-19 clinical trials must use a placebo control.

  • On July 17, 2020, ICAN sued the FDA in federal court demanding the entire clinical trial report for Menveo, just in case the agency was considering permitting this vaccine as a control in the AstraZeneca trial to be conducted in the United States.  On July 20, 2020, ICAN also filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding, among other things, that it also require that these clinical trials track all adverse events during the entire duration of the trial – not just for a limited time period.
  • Not long thereafter, in mid-September, in a highly unusual move, the full clinical trial protocols for the COVID-19 vaccines for which ICAN filed its petitions were released to the public.  See copies for each of the manufacturer’s vaccines: AstraZeneca, Pfizer, Moderna, and Johnson & Johnson.  Those protocols revealed that some of ICAN’s demands regarding the duration for tracking vaccine safety had been met.

 

Media


Tucker Carlson’s Explosive Interviview with RFK jr 26/11/2021

source: Odysee\AussieFighter


ICAN Lead Attorney, Aaron Siri on recent legal wins

source: theHighWire.com


Pandemic of the VACCINATED—75 Athletes Collapse from Heart Failure

source: Youtube\apidta

 

References

  1. The US Government Loses the Vaccine Debate
  2. ICAN vs. HHS: Key Legal Win Recasts Vaccine Debate
  3. ICAN v. FDA – ICAN Brings Lawsuit Related to “Placebo” in COVID-19 Clinical Trial

 

Keyword

1986, Adverse Reaction, Babies, Bigtree, Congress, Control, Del, Experiment, FDA, Field Surveillance, FOIA, Freedom of Information Act, GlaxoSmithKline, Health and Human Services, Hepatitis B, HHS, HighWire, ICAN, Informed Consent Action Network, Injection, Kennedy, Manufacturing, Merck, National Childhood Vaccine Injury Act, Nonprofit, Placebo, Plotkin, Reporting, RFK, Risk, Testing, US Department of, Warning 


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Gates Vaccine Murder Case

Gates Vaccine Murder Case

Gates Vaccine Murder Case

Re: the culpability of Bill Gates & partners in the death of a man that died as a result of taking their product (the AstraZeneca Covid vaccine), an experimental drug that promised to save lives.

 

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Facts of the Case

  • Dates: Nov 25, 2021
  • Location: Bombay, India
  • Court: Bombay High Court
  • Case #: Criminal Writ Petition (St.) 18017 of 2021
  • Plaintiff: Kiran Yadav (Petitioner)
  • Plaintiff’s Lawyer: Dipali Ohja
  • Defendant: Bill Gates, Adar Poonawalla, The Indian State
  • Trial Type: Writ petition
  • Justices: Sarang Kotwal & Nitin Jamdar
  • Status: TBD
  • Verdict: TBD

*This case was edited & reviewed by the Lawyer Dipali Ohja

*Updated Feb 6, 2022

 

Background

According to advocate Dipali Ohja….. “The plaintiff (petitioner), Kiran Yadav (mother of deceased) has sought prosecution of AstraZeneca’s (Covishield) manufacturer Bill Gates, his partner Adar Poonawalla and other Government officials and political leaders involved in the murder of a 23 year old man, Hitesh Kadwe, who lost his life because of vaccination. The deceased took the Covishield vaccine believing in the false narrative that the vaccine is completely safe and also owing to the compliance requirement set by the Indian Railways that only double vaccinated people would be allowed to travel.”  (1)

This is a Writ Petition for direction of Investigation through premier investigation agency C.B.I. AND granting  interim compensation of Rs. 100 Crores ($ 13.4 million USD)

 

Significance

This case is the world’s first vaccine murder case against Bill Gates and his Indian partner, Adar Poonawalla, CEO of the Serum Institute of India.

 

Plaintiff’s Argument

  • The Government of India’s AEFI (Adverse Event Following Immunisation) Committee has recently admitted that the death of another deceased Dr. Snehal Lunawat, was due to side effects of the Covishield vaccine. [copy of AEFI certificate is annexed to the petition] The said report has exposed the falsity of the claim made by vaccine syndicate that vaccines are totally safe. (1)

  • Plaintiff has claimed Rs. 1000 crores ($ 134 million USD) compensation and has asked for interim compensation of Rs. 100 crores ($ 13.4 million USD). (1)
  • Plaintiff has also sought Lie Detector, Narco Analysis Test of accused Bill Gates and others. (1)
  • Petitioner has also referred to the proofs of sinister plan of Bill Gates in the polio vaccination programme which spoiled the lives of more than 4.5 Lakh children in India as they suffered a new type of paralysis. This is also an additional proof of Bill Gates’ perverted and criminal mindset. The Plaintiff also relied upon the criminal antecedents of Bill Gates in killing 8 female children by unauthorized trial of HPV vaccines in India. (1)

  • As per experts, there is no chance of Bill Gates getting bail in the case and all the movable and immovable properties of the accused will be confiscated soon. (1)
  • Various social organizations and common people have decided to exercise citizen’s right to arrest the accused as provided under section 43 of Cr.P.C. As per the said section, any citizen can arrest Bill Gates, Adar Poonawalla and other accused and handover them to the police. (1)
 
Related Prior Judgements/ Cases
  • The Plaintiff also relied upon the criminal antecedents of Bill Gates in killing 8 female children by unauthorized trial of HPV vaccines in India and judgment of Constitution Bench of the Supreme Court in Kalpana Mehta’s Case (2018) 7 SCC 1, which is a strong proof against Bill Gates and his vaccine syndicate. (1)
  • In a case before the American Court regarding the side effects of MR vaccines, the Court accepted the settlement of compensation of 101 Million US Dollars (around Rs. 752 Crores) to the victim. (1)
  • In another case in America, the CIA, FDA’s office of criminal investigation, recovered around 10.2 Billion US Dollar (around Rs.76,00 crores) from Pharma Company GlaxoSmithKline for various offences including suppression of side effects of the medicines and putting the life of Americans in danger. (1)

 

Defendant’s Argument

tbd

 

Decision

tbd

RFKjr on Bill Gates

source: Naomi Wolf

Bill Gates India Vaccine Program

source: Reality Check w Ben Swann

Bill Gates Conflict of Interest

source: shortXXvids

Gates, GAVI & WHO

source: theHighWire.com

Corruption in WHO/GAVI

source: Corona-Ausschuss

Meet Bill Gates

source: the Corbett Report

 

References

  1. https://indianbarassociation.in/worlds-first-vaccine-murder-case-against-bill-gates-adar-poonawalla-filed-in-indias-high-court/

 

Keyword

Vaccine induced death, mRNA vaccine, Covishield, vaccine, Dipali Ohja, India, Bill Gates, Adar Poonawalla, vaccine misinformation, Indian High Court, GlaxoSmithKline, Serum Institute of India, Snehal Lunawat, Writ petition, Hitesh Kadwe, murder


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