The Myth of Informed Consent
Segment # 027
There have been significant complaints from scientist and doctors about the lack of Pfizer COVID vaccine safety trial data released to the public. In a little over 100 days Pfizer submitted their test data to the FDA and obtained an Emergency Use Authorization for their Pfizer BioNtech vaccine for two shots plus a booster with approval for a fourth shot looming on the horizon. This demand for data has been exacerbated by the fact that specifically pregnant women and children were excluded from the test group and they are now not only included in the EUA but also, in some cases, mandated for the shots. Also festering early in the COVID timeline were charges that Pfizer was faking their test data. As you will note below the process as it has been implemented under the Biden FDA is a sham. The obvious efforts to hide data can logically cause any objective observer to conclude that Pfizer and the FDA are colluding to preserve their power to control the American Public. Ron Johnson’s recent forum in Washington DC with scientists and medical experts gave hope that this fraud will eventually come to an end.
WINNING: A Court Victory for Transparency on Pfizer Covid Vaccine Data
January 8, 2022 / brianpeckford
BY STACEY LENNOX JAN 07, 2022 12:07 PM ET
It is a big week for court action regarding Covid vaccines. The Supreme Court will hear arguments on President Biden’s authoritarian Covid vaccine mandate on Friday. On Thursday, attorney Aaron Siri scored a massive win for transparency in the FDA approval process. Siri sued on behalf of the Informed Consent Action Network (ICAN) to force the FDA to produce all the data submitted by Pfizer to license its mRNA vaccine.
Initially, the FDA requested permission to release 500 pages a month. Estimates put the time for full disclosure at that rate at 75 years. Obviously, this request was an unconscionable obfuscation of medical information that Americans and their doctors should understand to meet the burden of informed consent for medical treatment. The ridiculous timeframe achieved further skepticism about what Big Pharma and the FDA are hiding.
According to Siri’s Substack:
I am pleased to report that a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month!
This is a great win for transparency and removes one of the strangleholds federal “health” authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.
The analysis by independent researchers is vitally important. In November, The British Medical Journal (BMJ) published allegations from a whistleblower regarding data integrity issues. Pharmaceutical companies pay outside organizations to run their clinical trials. The whistleblower, Brook Jackson, held the position of regional director for Ventavia and provided information about the company’s trials in Texas to the FDA. Some of the concerns she raised were:
Participants were placed in a hallway after injection and not being monitored by clinical staff
Lack of timely follow-up of patients who experienced adverse events
Protocol deviations not being reported
Vaccines not being stored at proper temperatures
Mislabelled laboratory specimens
Targeting of Ventavia staff for reporting these types of problems
Ventavia fired her the day she came forward with the allegations. The only way to verify her allegations is to have an independent review. It may also highlight other problems in the clinical trial process. According to the BMJ, the agency is notoriously underfunded to do appropriate inspections.
Jill Fisher, a professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials, told the BMJ, “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities.”
The BMJ also noted a 2007 report from the Department of Health and Human Service inspector general:
In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites. Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.
The Pfizer trial included nearly 44,000 participants between the ages of 12 and 85 at 166 study locations. According to the BMJ, the FDA released a report in August 2021 summarizing its inspections of the trial sites. Nine of the sites received an inspection, if you can even call it that. The inspection officer noted, “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”
Some allegations made by the whistleblower are echoed by patients who allege they have suffered an injury following a Covid vaccine. In a November 2021 roundtable with Senator Ron Johnson (R-Wisc.), Americans alleged that there was no way to report their multi-system symptoms on the app provided to participants. The potential side effects were assumed. Many said they had trouble accessing trial staff to discuss their issues, were not offered medical support, and noted that trial staff did not accurately reflect their reported reactions in trial reports. Some said the trial reports did not include their reaction at all. Instead, they appeared to be included in the population that dropped out of the trial.
Additionally, a new preprint study from Kaiser Permanente Northwest demonstrates that the CDC and FDA grossly underestimated the risk for cardiac side effects in young men. The researchers used claims data and searched for specific search terms in the clinical record that indicated one of three cardiac complications, myocarditis, pericarditis, and myopericarditis. They found the risk was 1 in 1,860 for males 18-24 and 1 in 2,650 for boys 12-17. The CDC estimates in these age groups using the tracking system that cannot be named, VAERS, were closer to 1 in 16,000 for boys 12-17 and 1 in 20,000 in males 18-24. Kaiser’s more detailed assessment significantly changes the risk/benefit calculation for healthy young men if an analysis of similar claims data sets can replicate it in similar data sets.
Medical experts across the spectrum, including those previously considered mainstream, are beginning to question the FDA’s judgment. After learning of the court’s order to the FDA, Dr. Marty Makary, a medical researcher from Johns Hopkins, tweeted, “FDA asked a court for 75yrs to release documents related to the Pfizer vax. Today, a smart judge rejected their request. This is the same @US_FDA that bypassed experts to authorize boosters for young ppl. Thank u @AaronSiriSG for bringing public accountability to a broken agency.”
Siri summed the importance of the ruling the best:
No person should ever be coerced to engage in an unwanted medical procedure. And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.
In 2022, voters need to ask Republicans serious about elected office how they propose to reform the bureaucracy. Congress created the agencies, and they must be brought to heel by Congress if we want transparency and accountability for their actions.
Source : PJ Media
Pfizer Moves to Intervene in High-Profile Case Dealing With COVID-19 Vaccine Safety Data
By Zachary Stieber
January 26, 2022 Updated: January 26, 2022
biggersmaller
Pfizer has asked a federal court to let it intervene in a high-profile case that has seen U.S. drug regulators try to slow-walk disclosure of data on Pfizer’s COVID-19 vaccine.
Pfizer says it supports disclosing the data but wants to ensure that information exempt from disclosure under the Freedom of Information Act (FOIA) is not “disclosed inappropriately.”
Public Health and Medical Professionals for Transparency filed a lawsuit against the Food and Drug Administration (FDA) last year after the agency, responding to a FOIA request, claiming it would take 20 years to produce the data on the vaccine.
The FDA later asked a judge to give it 75 years, but the judge rejected the request and ordered the regulator to produce 55,000 pages a month, which would give it about eight months to fully disclose the records.
About two weeks after the order, on Jan. 21, lawyers representing Pfizer asked U.S. District Judge Mark Pittman, a Trump nominee overseeing the case, to allow the company to intervene.
Pfizer was not aware of the case until executives read news reports about it last month and now wants to help FDA staffers review the documents in question to ensure proper redactions are made, according to the new filing.
Emergency Use Authorization (EUA)
Description: Congress created the EUA in the Project BioShield Act of 2004 to give the public health system access to a greater range of medical products during a declared emergency. The EUA mechanism provides appropriate participant protections based on the circumstances of the emergency. EUAs are intended to allow for faster use of a product than under an IND/IDE.
FDA Approval: FDA is required to review and approve the request for EUA.
IRB: Does not require IRB review and approval.
Informed Consent: Written, signed and witnessed informed consent is not automatically required but may be required at the discretion of the FDA commissioner. Distribution of information (e.g., fact sheets) for healthcare professionals and recipients that contains information on product safety, available alternative products, and the right to refuse administration of the EUA product is required.
Protocol Training: No specific investigator training requirements, but these may be added as a condition of authorization for the EUA by the FDA commissioner.
Adverse Event Monitoring & Reporting:Adverse event monitoring and reporting is required at the discretion of the FDA commissioner. The FDA will require MEDWATCH and VAERS reporting for all EUA products.
Recordkeeping & Access: Recordkeeping and access to product distribution and administration records required at the discretion of the FDA commissioner.
Duration of Approval: Up to one year from the date of the declaration of emergency or for as long as the §564 emergency declaration is in effect, whichever is shorter.
Information adapted from: U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. “Emergency Use Authorization” online course. Available at www.bt.cdc.gov/training/eua/index.html. Accessed January 31, 2012.
As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which reauthorization may impact provisions relevant to emergency use of medical products.
