Australia's Adverse Drug Event Reporting System is Broken

We are not safe and those responsible for keeping us safe do not care

Nov 11, 2023

In published papers, Substacks and presentations I have repeatedly said that Australia’s Adverse Drug Event Reporting System (Drug Adverse Event Notification system or DAEN) is broken. Why is this incredibly important to understand?

Before 2018, when a drug was developed and tested in clinical trials over many years, a fairly reasonable amount of clinical safety and efficacy data was generated upon which one could largely rely when the drug was released for marketing. This might consist of as many as dozens of clinical trials and many thousands of patients. It was not a perfect system to assure safety because some serious drug adverse events might occur one in a thousand or one in ten thousand people and it was difficult to determine if the adverse event was due to the drug or just occurred by chance. In order to assist in the determination of whether or not the drug caused the serious adverse event, a number of criteria were established called the Bradford Hill criteria.

I won’t go into the Bradford Hill criteria here but suffice to say that it takes considerable time for each suspected adverse event to be investigated by experience clinical and scientific staff and in most cases follow up with the reporting doctor or patient is required and supporting documentation including comprehensive clinical records need to be retrieved. This all takes time.

But when Australia’s Provisional Approval System was introduced in 2018 - everything changed. The COVID-19 “vaccines”, even though they were a form of experimental gene therapy, were released under Provisional Approval with only a single clinical trial. We also now know that the follow-up safety observations were prematurely terminated and many subjects simply disappeared from the database and the relatively high number of deaths in the vaccinated group were not reported in a timely manner to the US FDA before these injections were “approved”.

It was a disaster waiting to happen………

Under normal circumstances, there was a safety net. This safety net are the adverse drug reporting (ADR) systems around the world including the US Center for Disease Control (CDC) Vaccine Adverse Event Reporting System (VAERS), our own DAEN system and many other similar systems.

The problem is that these ADR systems rely on the diligence and skill and of the staff operating these systems and the independence and integrity of those managing the system.

We are in a position now where it is indisputable that the COVID-19 “vaccines” have been reported to cause more serious adverse reactions (including death) than any drug in the history of the pharmaceutical industry. But the question must be asked: Is the problem really much worse than reported?

Certainly we know our DAEN system is completely broken as it only admits to 14 deaths being caused by the COVID-19 “vaccines”. We know this is not true. Our DAEN system is not picking up important safety signals. More than 1000 reports of deaths have been recorded in the DAEN system but the TGA continues to admit to only 14 deaths due to the “vaccines” and even more incredulously the TGA admits to no child deaths despite 9 such reports. It is primarily on this basis that our Therapeutic Goods Administration can claim the COVID-19 “vaccines” are “safe and effective”.

How can the TGA get away with this? Easy. The system is not transparent. We do not know the full details of the reported cases and we do not know the conflicts of interest of those managing the system. Reports of death and serious adverse events can just be hand waved away and nobody is the wiser. Perfect.

It is unconscionable that the TGA claims of “vaccine” safety rest almost entirely upon such a subjective and opaque system which is vulnerable to bias and outright minimisation of the safety signals. We know the TGA have been lying to us for more than 3 years about the safety and effectiveness of the COVID-19 “vaccines”…..why should we believe them now when they say the DAEN system is not showing any concerning safety signals? Why should we believe them when they refuse to hold a Royal Commission into the COVID pandemic policies? Why should we believe them when they refused to investigate more than 30,000 non-COVID-19, post-vaccination, unexplained Australian deaths above what would normally be expected following the rollouts of the “vaccines”?

A paper was just published which gives some insight into the US VAERS which illustrates what I am saying. See the paper below by Jennifer Block, investigations reporter, British Medical Journal 10 Nov. 2023 entitled “Is the US’s Vaccine Adverse Event Report System Broken?”: