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.
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.