Burden of Proof

How the burden of proof of safety of vaccines and drugs has shifted from the drug regulators to YOU

The drug regulators (US FDA and our Australian Therapeutic Goods Administration (TGA) use to be the gatekeepers of safety regarding new drugs and vaccines. Submissions were heavily scrutinised, questions were asked, data reanalysed and assurances demanded. Now, the game has changed. There are new cosy public-private partnerships where the drug regulators appear to be captured by Big Pharma and do their bidding. Drug regulatory staff often move to Big Pharma in rewarding revolving door career moves which may also include lucrative expert commentary appearances on the main stream news media.

With the relatively recent introduction of expedited drug approvals involving relative little safety, efficacy or quality control data, Big Pharma does not need to wait years for approval or spend enormous research and development before the dollars come rolling in. In the past, the proof of safety for new drugs was generated over many years in numerous highly monitored clinical trials where every adverse event was meticulously recorded and assessed, often by international teams of experts, person by person, event by event. Now, with expedited drug approvals the assessment of safety is largely left to the arbitrary and passive adverse drug report reaction (ADR) systems following release of new drugs. These ADR systems are commonly staffed by anonymous people with likely commercial links or affiliations to Big Pharma either in terms of research grants, other funding or appointments. We just do not know. It is all secret.

What is more worrisome is that the burden of proof of adverse events or death is now left to the public. The drug regulators say without qualification the experimental COVID-19 gene-based “countermeasures” developed by the US Dept of Defense (DoD) are “safe and effective” despite the fact that the normal safety tests and criteria have not been applied and the US DoD takes not responsibility for their safety. It is also looking like anybody involved in the approval of these countermeasures is protected from liability and the contacts for their supply are secret.

The TGA said on 13 Dec. 2022:

“Before any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.”

https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccines-undergoing-evaluation

With COVID-19 “vaccines” producing the highest incidence of death and serious adverse events in the history of the pharmaceutical industry, this statement appears hollow.

In addition, FDA panel member and New England Journal of Medicine editor-in-Chief, Dr. Eric Rubin, moments before he voted to approve the Pfizer mRNA shots for children said:

“We’re never gonna learn about how safe the vaccine is unless we start giving it - that’s just the way it goes”. pic.twitter.com/cTKnXYy8uw

Greg Hunt, the former Federal Health Minister, said of the Pfizer and other Covid injections, “The world is engaged in the largest clinical vaccination trial.  I would go further and say, in history…”

So, where does that leave us, the public? We are left with the burden of proof to satisfy a court that the COVID-19 so-called “vaccines” caused death or serious injury. These courts, in my experience, do not look at the data. They say it is not their job to look at the data. They are incapable of looking at the data. They simply say if the “experts” say the “vaccines” are safe, then they must be safe.

Vaccines are not safe. They are complicated therapeutics usually requiring up to 10-12 years to research and develop. The COVID-19 “vaccines” were developed in 10 months.

The game has changed…..The drug regulators are protected from liability. They are not doing their job. The burden of proof of safety is now on YOU. Good luck!