“Turbo cancer” does not exist. Oncologists reject the notion entirely. Aside from the ridiculous name, there is no evidence to support it. Bold claims promoting it as fact, are not merely invalid, but scientifically incompetent. Proponents offer no clear definition, other than insist DNA can be damaged by COVID-19 vaccines, leading to aggressive cancers. As the “died suddenly” trend begins to die out, “turbo cancer” is in top gear.
We’re told residual DNA in vaccines is responsible. Or, the vaccines enter the cell nucleus. Or, it’s not a vaccine – it’s gene therapy. Or, simian virus 40 (SV40) is the cancer-causing agent in mRNA vaccines. This last claim has origins reaching back to the 1950s and 1960s when discovery of SV40 present in oral polio vaccine was responsible for safety concerns and later cancer fear-mongering. Mechanisms of infection were verified as possible but rare, and allegations of a surge in cancers decades later, are unverified. SV40 was one of the first oncogenic viruses discovered. These viruses cause cancers in experimental animals and in some cases humans. However, not in this case. When it comes to COVID-19 vaccines, some mRNA preparations may contain SV40 fragments, which aren’t the same as the virus and are not carcinogenic. In fact there is no evidence of this ever having occurred. The fragments occur because part of SV40’s DNA sequence is used in the beginning of mRNA vaccine development.
As for so-called “turbo cancer” [Wikipedia] the term has its origins at least as far back as November 2020, according to the indefatigable Orac, who identified it in a smarmy comment to a forum post about Moderna’s request for clearance of its mRNA vaccine. By November 2022, use of the term had spiked online. It was being promoted and amplified by a number of anti-vaccine activists on social media. One such group was RFK Jr.’s Children’s Health Defense (CHD) which had emerged as a major distributer of COVID disinformation during the pandemic. In January 2023 AFP fact-checked a November 2022 Rumble video produced by CHD, featuring disgraced Canadian doctors Charles Hoffe and Stephen Malthouse. AFP reported that oncologists had informed them the claims were baseless, and added:
“There is no evidence in Canada or globally that vaccination leads to any forms of cancer or that Covid vaccines lead to rapid advancement in cancers,” British Columbia’s Ministry of Health said in a statement emailed January 11. “There is also no evidence to support Covid vaccines leading to harm to the immune system; on the contrary evidence strongly supports that Covid vaccines produce strong, effective immune responses that protect from serious illness from SARS CoV-2.”
The Therapeutic Goods Administration (TGA) is aware of misinformation in recent media and online reports that claim the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case.
So opens the TGA report Addressing misinformation about excessive DNA in the mRNA vaccines. It is, for those of us aware of this issue, an understatement. The sheer volume and scope of misinformation, combined with relentless pressure from repeat offenders including members of the Australian parliament, more accurately suggests a campaign. A calculated campaign of misinformation designed to spread fear and intimidate the vaccine hesitant. Despite there being accepted means for discerning DNA residue in vaccines, two claims persist. Namely levels are hundreds of times greater than the accepted safe level, and that aggressive cancers will, and do, directly result.
Background
The original claim stems from a preprint paper by Kevin McKernan dated 11 April 2023. Amplitude, via the Australian anti-COVID vaccine lobby, was lent to this claim in July 2023. The legal guru behind all Australian court cases to challenge approval of COVID-19 vaccines, retired barrister Julian Gillespie, penned The Canaries in the Human DNA Mine. Falsely labelled “peer reviewed” by his anti-vaccine compatriots, it was published in the unabashedly anti-vaccine International Journal of Vaccine Theory, Practice, and Research. Gillespie also crafted the case material used by Dr. Julian Fidge, in what became known as the Fidge v Pfizer case in which Fidge was represented by Katie Ashby-Koppens of P. J. O’Brien and Associates. I summarised the unsuccessful case here, in April this year. Gillespie and Co. followed with a conspiratorial constitutional complaint against the presiding judge, Justice Helen Rofe. Then via a High Court writ they targeted Chief Justice Debra Mortimer for not accepting their complaint. Both complaints were lodged on behalf of Dr. Fidge
Around the same time, the outrage manufactured by the anti-vax lobby shifted from the claim in Fidge v Pfizer that mRNA vaccines were Genetically Modified Organisms (GMOs), to the claim that vast amounts of DNA were contaminating these vaccines. Julian Gillespie, who wants a COVID Royal Commission, publishes for his “good substack folk” regularly on DNA contamination. He claims to have commissioned Canadian molecular virologist Dr. David Speicher to pursue said contamination, ultimately announcing confirmation on 6 June. Speicher was not a surprise choice for Gillespie. He had published with McKernan, Jessica Rose, Maria Gutschi, and David Wiseman in Canada in October 2023, reaching the contamination conclusions Gillespie wants to hear about.
It bears stressing that Kevin McKernan’s preprints lost credibility long ago, when it became apparent the vials he tested were of unknown origin. More so, if origin is unknown then cold chain transport requirements are by default, breached. In October 2023, David Gorski referred to McKernan’s initial preprint as an “awful study” and follow up studies being “equally as bad”. Thus it is unsurprising further attempts were made to label COVID vaccines as DNA contaminated. The Global Vaccine Data Network provide an excellent refutation of what they call Plasmid-Gate. As a highly COVID-19 vaccinated nation, Australia is used in their piece as an example to debunk the claim of so-called “turbo cancers” resulting from COVID-19 vaccination. SBS recently reported that last year, biologist Phillip Buckhaults from the University of South Carolina spoke before a state panel postulating the possible consequences of DNA contamination. When his comments took flight on social media he quickly followed up on X with insistence that such a risk was “purely theoretical”. They further reported that:
Dr Paul Offit of the Children’s Hospital of Philadelphia said [DNA] fragments were “clinically and utterly harmless”.
“These DNA fragments would have to enter the cytoplasm, which is that part of the cell outside of the nucleus, and our cytoplasm hates foreign DNA,” Offit said. “It has innate immune mechanisms as well as enzymes to destroy foreign DNA.”
Also interested in supposed DNA contamination of mRNA vaccines are Senators Malcolm Roberts, Gerard Rennick, Ralph Babet, Alex Antic and Russell Broadbent. Rennick has pushed both the GMO and DNA contamination angle for well over a year. Broadbent remains vocal in parliament to this day, has congratulated Port Hedland Council for calling for an end to COVID vaccines and has furnished Australia’s PM with material on the matter. Broadbent raised his concerns in parliament on 18 November, and I recommend watching this 5 minute video of him speaking.
Another voice to echo Julian Gillespie, is erstwhile ABC journalist Maryanne Demasi. Perhaps her contribution is best summed up in the COVID vaccine conspiracy film she narrated, The Truth – About COVID-19 shots. Erroneously labeled a documentary, it was raved about by Gillespie. And understandably so, given that it includes all his favourite vaccine conspiracies, champions the case and complaints associated with Fidge v Pfizer and lists Gillespie as a source. Demasi also has a Substack account, and has kept her subscribers up to date with DNA contamination developments. In addition Demasi claims the TGA “hides from” reports of SIDS, post vaccination, the TGA and FDA ignored DNA contamination of the HPV vaccine Gardasil, and of course that the TGA response to the claim that mRNA vaccines exhibit DNA contamination, is wrong.
Last we visited developments related to the Fidge v Pfizer case, we had a long look at ambitious arguments arranged to convince Federal Court Chief Justice Debra Mortimer to uphold a constitutional complaint against Justice Helen Rofe. Rofe had summarily dismissed Dr. Julian Fidge’s application for injunctive relief under the Gene Technology Act on 1 March 2024. The judgement is here and my post summarising the case is here.
Fidge was found to lack standing and the case did not proceed. As I mentioned at the time, this was the latest failure of case design by solicitors Katie Ashby-Koppens and Peter Fam, and retired barrister Julian Gillespie. By 22 March Ashby-Koppens and PJ O’Brien and Associates had filed the constitutional complaint with the Chief Justice, alleging Justice Rofe had concealed “her connections to Pfizer and the pharmaceutical industry, before dismissing a case to Pfizer’s advantage”. Reading the complaint, one is struck by both the tenuous nature and the sheer range of the arguments put forward to establish motive, as alleged by the complainants.
Justice Rofe omitted to disclose her role as a barrister acting for Pfizer in patent law cases around 20 years before; hence the “connections to Pfizer”. Yet her connections to “the pharmaceutical industry” rely on one following a convoluted web of associations, that are presented by the complainants as potentially nefarious only through the lens of conspiracy theory thinking. In fact the reader must also accept there are inherent flaws and a predisposition to deception associated with scientific and medical research per se, and indeed any acceptance of COVID-19 vaccines and/or COVID public health initiatives.
On 27 June a writ of mandamus was lodged on behalf of Dr. Julian Fidge at the Brisbane registry of the High Court of Australia. The defendant named was Chief Justice Debra Mortimer. As we’ve observed before, such a writ commands or dictates that an individual or government department carry out a duty that falls within their remit. We saw this in the AVN case targeting the Secretary of the Department of Health to use his powers under the Therapeutic Goods Act to cancel or suspend the provisional registration of three Covid-19 vaccines, including the Pfizer and Moderna vaccines (Australian Vaccination-Risks Network Incorporated v Secretary, Department of Health [2022] FCA 320). They too were found to lack standing.
Clearly Julian Gillespie and Katie Ashby-Koppens feel that three months is long enough to wait. Justice Mortimer has not commented and Gillespie writes that they have argued in “countless correspondence with her office ever since the Complaint was lodged with her”, pointing out their argument. It basically runs as follows:
Helen Rofe did not disclose her prior relationship with Pfizer and thus cancelled out her own judicial authority. This invalidated her 1 March ruling. Justice Mortimer should have informed her of this, Gillespie reasons. He has also peddled ad nauseam his “not a judge” theory. So, let’s look at this. Gillespie cites the High Court ruling QYFM v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs (May 2023), paragraph 26. He quotes:
The question arising in the circumstances of the present case falls to be resolved at the level of principle within the framework established in Ebner v Official Trustee in Bankruptcy. Foundational to that framework are two propositions. One is that impartiality is an indispensable aspect of the exercise of judicial power. The other is that “[b]ias, whether actual or apprehended,connotes the absence of impartiality” … an actuality or apprehension of bias is accordingly inherently jurisdictional in that it negates judicial power.
With the negation of judicial power Justice Rofe is apparently “not a judge”. But let’s read that paragraph again, with all the text and a minor change in emphasis:
The question arising in the circumstances of the present case falls to be resolved at the level of principle within the framework established in Ebner v Official Trustee in Bankruptcy. Foundational to that framework are two propositions. One is that impartiality is an indispensable aspect of the exercise of judicial power. The other is that “[b]ias, whether actual or apprehended, connotes the absence of impartiality”. Leaving to one side exceptional circumstances of waiver or necessity, an actuality or apprehension of bias is accordingly inherently jurisdictional in that it negates judicial power.
Exceptional circumstances of waiver or necessity. Could there be circumstances of necessity? I’ve no idea at this point, but it seems relevant. Gillespie assumes he and others so inclined deserve the attention of one of Australia’s most senior judges. Despite being wrong five times in two years, they now seek to force the hand of the Chief Justice of the Federal Court of Australia. He accuses Chief Justice Mortimer of not “properly investigating Helen Rofe, her workmate”.
Another key reason to take this position is the belief that the ruling by Justice Rofe on 1 March is “unappealable”, yet Chief Justice Mortimer “wants to see us appeal the 1 March decision despite Dr Fidge’s legal team telling her that decision is unappealable”. The logic for this also stems from the “not a judge” mantra. The Federal Court of Appeal has jurisdiction to hear a judicial decision from a single judge. As Gillespie alleges Justice Rofe negated her judicial authority, the case did not have a single judge and they “have no decision vested with judicial authority”. Thus, the Gillespie contention is that it follows that the case is “unappealable”.
Finally, this entire manufactured affair provides an opportunity for chasing donations and to promote Australia’s anti-science senators in attacking COVID-19 vaccines. An initiative of Children’s Health Defense Australia Chapter is Section 72. The website seeks to direct devotees to lobby MPs to act in response to the constitutional complaint against Justice Rofe, and to date claims almost 9,000 have “taken action”. It also claims without any evidence that, “there is also the possibility other members of the same court are implicated in this misconduct of Justice Rofe”. Also:
Senators Malcolm Roberts, Gerard Rennick, Ralph Babet, Alex Antic and Russell Broadbent all intend to support the Complaint being dealt with properly by Parliament under Section 72(ii) of the Constitution…
The Justices of the High Court and of the other courts created by the Parliament–
(ii.) Shall not be removed except by the Governor-General in Council, on an address from both Houses of the Parliament in the same session, praying for such removal on the ground of proved misbehaviour or incapacity:
The proposed aim of this constitutional complaint has been to push for Justice Rofe’s removal from the Federal Court. Allegations of corruption and COVID conspiracy theories shape the thinking of those involved. It will be interesting to see what response if any the complaint elicits and how the recent High Court filing targeting Chief Justice Mortimer for “not doing her job” plays out.
This particular anti-vax legal saga is likely far from over.
The title of “Fidge v Pfizer” given to the Federal court case file number VID 510 of 2023, tells us little about those behind the case and what motivates them. Dr. Julian Fidge stepped up to be the applicant in a case “designed”, we’re told on the Maat’s Method website (archive), by retired barrister Julian Gillespie and solicitor Katie Ashby-Koppens of P. J. O’Brien and Associates.
Those names should sound familiar to anyone with an interest in cases brought to the Federal and High courts of Australia by anti-vaccination activists represented by Peter Fam of Maat’s Method. The case was the third brought by this group, in an extended campaign to discredit COVID-19 vaccines. It alleged mRNA COVID-19 vaccines are unregistered GMOs, and their manufacturers guilty of breaching legislation. The initial two cases have been covered on this blog here and here.
Background
Seeking to invalidate the approval of COVID-19 vaccines, the so-called evidence in the first two cases relied heavily on unverified adverse reactions reported to the TGA. Having made these claims, the affidavits advanced various “gotcha” scenarios using the Therapeutic Goods Act (TG Act) in which the Secretary of the Department of Health, was supposedly duty bound to remove approval of COVID-19 vaccines. Neither case was successful in establishing legal standing to prosecute proceedings.
The second case, known as The Australian Babies Case included Dr. Julian Fidge as one of the six applicants. It also advanced a “gotcha” argument against the Secretary for failing to comply with section 30C(2) of the TG Act. This was unique in that section 30C provides for Consultation with the Gene Technology Regulator (OGTR). They argued that the mRNA vaccines were GMOs and the Secretary had failed to give written notice to the Gene Technology Regulator, as specified in section 30C. The affidavit contended:
It appears that there has been non-compliance with a statutory condition in the TG Act. […] The plaintiffs contend that non-compliance with the statutory obligation mandated by s 30C(2) leads to the invalidity of the registration decision that followed.
That case aimed to “fix the law on standing” by arguing the applicants warranted a unique “special interest”. It was filed with the High court in December of 2022 and remitted back to the Federal court in March 2023. Announcing its discontinuation in April 2023, Peter Fam observed that they had been working simultaneously on other more promising cases that would be announced within weeks. And thus, in July 2023 came the announcementWe are suing Pfizer and Moderna directly – because their shots are GMOs. They had sent letters of demand to Pfizer, Moderna, the Therapeutic Goods Administration (TGA) and the Office of the Gene Technology Regulator (OGTR).
Julian Fidge was no doubt a willing applicant, ready to take one for the team. His eagerness to reject government mandates and AMA requirements related to COVID-19 is well documented. He has a strong association with the Australian Medical Practitioners Society; a group that has been instrumental in opposing COVID-19 vaccines and related mandates. They also strongly support the claim mRNA vaccines are GMOs. Fidge also had previously challenged the Medical Board of Australia over conditions placed on him following an anti-vaccine post on Facebook and has been reported as the doctor who “reversed Australia’s ban on ivermectin”. Fidge has had regular contact with Julian Gillespie, Katie Ashby-Koppens and Peter Fam. We know this anti-vaccine legal team had been working on this case for months, and no doubt modified the application to suit Dr. Fidge. With that, let us turn to the application and ruling.
Fidge v Pfizer
The case was heard before the Hon Justice Helen Rofe. Justice Rofe delivered her ruling on 1 March 2024. Her reasons for judgement are comprehensive with respect to legislation and case law, and could be reasonably summarised as follows.
On 6 July 2023 Fidge filed an injunction against Pfizer and Moderna pursuant to section 147(1) of the Gene Technology Act 2000 (GTA), on the basis that:
The mRNA vaccines are or contain GMOs as per section 10 of the GTA.
To “deal with” GMOs Pfizer and Moderna (respondents) were required as per section 40 of the GTA to secure licences from the OGTR, but failed or refused to do so;
The respondents knew after vaccine approval that; (i) the vaccines are or contain GMOs, and (ii) the vaccines were not licensed as per s. 40 of the GTA;
The respondents dealt with and continue to deal with the vaccines in Australia by importing, transporting and distributing them. This constituted “vaccine dealings”;
The vaccine dealings without a licence are unlawful as per s. 32 and s. 33 of the GTA. This constituted “breaches” of the GTA;
Fidge is an “aggrieved person” as per s. 147(1) of the GTA because “he wasn’t fully informed that this new class of drugs is capable of transferring genetic material”, which Fidge considers poses significant adverse health risks.
Dr. Fidge asserted he had standing under section 147(1) of the GTA on “a number of grounds” citing his:
“Professional capacity” as a GP who oversaw administration of 10,000 COVID-19 vaccinations, and may be exposed to legal claims from his patients, as he was unable to advise them of the vaccine-GMO status. He has also failed to “do no harm” as he contends the vaccines are or contain GMOs, rendering them unsafe;
“Personal capacity” as the recipient of three Pfizer vaccines;
“Private capacity” due to “severe moral injury, mental harm and suffering”, due to the large number of “deaths, illnesses and injuries reported to the TGA to date”;
“Public capacity” as a doctor subject to a duty to preserve human life and protect the health and safety of the public. He is compelled to speak for all Australians and believes his professional codes of conduct mean he is obliged to inform patients about the vaccine-GMO status to properly provide informed consent.
Before going on it’s worth pausing to note that the first COVID-19 vaccine to arrive in Australia is Astra Zeneca; an adenovirus organism. It was registered with the OGTR in February 2021 as a genetically modified vaccine, with risk assessment approval describing it as a GMO. The AZ vaccine has not attracted attention from this group as a dangerous GMO. That allegation is reserved for mRNA vaccines, following intense focus on reports of plasmid DNA in mRNA vaccines, a number of animal studies into mRNA vaccines and pre-COVID studies of nanoparticles, all frequently cited by opponents of mRNA vaccines.
The respondents, Pfizer and Moderna, sought a summary judgement under s 31 A(2) of the Federal Court Australia Act and rule 26.01(1) of the Federal Court Rules on the basis that the applicant lacks standing to seek relief under s 147(1) of GT Act. Section 31 A(2) of the Federal Court Australia Act, states that, the court may give judgement for one party against another in relation to the proceeding if:
(a) the first party is defending the proceeding; and
(b) the court is satisfied that the other party has no reasonable prospect of successfully prosecuting the proceeding.
Rule 26.01(1) of the Federal Court Rules states that a party may apply to a court for an order that judgement be given against another party because:
(a) the applicant has no reasonable prospect of prosecuting the proceeding; or
(b) the proceeding is frivolous or vexatious; or
(c) no reasonable cause of action is disclosed; or
(d) the proceeding is an abuse of the process of the court.
On 10 August 2023 Justice Rofe ordered that the respondents application for summary judgement be heard in October, separately from Julian Fidge’s application for injunctive relief. Rofe did not accept that Fidge had established he had standing to bring his application, and thus, allowed the respondents’ applications for summary judgement. Rofe observed that the respondents denied the vaccines were GMOs or that they had breached the GTA. In addition she observed that the position of the OGTR, “is that the vaccines are not GMOs”.
In paragraph 15 Justice Rofe writes:
The parties agreed that the question of whether Dr Fidge has standing is premised on the assumption (for the purposes of the respondents’ applications) that the vaccines are GMOs and the respondents therefore breached the Act by dealing with the vaccines. Thus, for the purposes of this summary judgment application, I do not need to determine whether the vaccines are GMOs or the resulting question of whether Pfizer and Moderna breached the Act by failing to obtain licences for the Vaccine Dealings. I have therefore disregarded any evidence filed by the parties that address whether the vaccines are GMOs.
Alas, once again the result for the Gillespie group is to be ruled as lacking standing. Dr. Julian Fidge is not a “person aggrieved”, and thus no different from any ordinary member of the public. Also, rather helpfully Justice Rofe applies case law to expand on why summary judgement under the Federal court Rules and Act, is appropriate where standing is absent. If an applicant lacks standing there are no prospects of success. Indeed, citing precedent, Rofe observes that an abuse of process arises if the applicants case is “foredoomed to fail”, as would always be the case without standing. Rofe opens paragraph 22 with:
It is clear that without standing an applicant has no prospect of success, no reasonable cause of action and the proceeding is an abuse of process.
Standing
Justice Rofe also elaborates on the importance of standing in this case by referring to precedent. Standing dictates that a person must be an appropriate party to instigate proceedings. Various terms such as “sufficient interest”, “special interest”, “real interest” or “sufficient material interest” are one consistent test. In fact, if standing was accorded to any citizen, the law may be, “abused by busybodies and cranks and persons actuated by malice“. In addition persons or groups who feel very strongly about an issue will be prepared to put another party, whose actions have not affected them, to great cost and inconvenience in mounting a defence.
Most interestingly, Justice Rofe referred to Australian Vaccination-Risks Network Inc v Secretary, Department of Health (2022) 292 FCR (AVN’s appeal) in reinforcing the lack of standing for Fidge. Justices hearing the appeal agreed that the AVN lacked standing. We can see that Justice Rofe has not missed the similarity between Fidge seeking to enforce performance of a public duty via the GTA, and the AVN seeking to force the Secretary of the Department of Health to execute duties under the TG Act. Rofe cites:
It is quite clear that an ordinary member of the public, who has no interest other than that which any member of the public has in upholding the law, has no standing to sue to prevent the violation of the public right, or to enforce the performance of a public duty.
Over paragraphs 28 to 32 Justice Rofe references the initial AVN case and their failure to demonstrate standing to further demonstrate why Julian Fidge also lacked standing. One does not find it difficult to imagine that this would not have sat well with the brains behind these three cases; Julian Gillespie, Katie Ashby-Koppens and Peter Fam.
Justice Rofe addresses the GTA extensively, and in a manner that is beyond the purpose of this post. In doing so she notes that Fidge has only alleged Pfizer and Moderna contravened the offences in s 32 and s 33 of the Act. Rofe also rejects evidence presented by Fidge claiming Pfizer’s understanding of the Act is so “narrow, myopic and restrictive” it prevents anyone from having standing to challenge breaches of the GTA. Further, the GTA deals with GMOs that present a biosafety risk to people or the environment and not “the quality, efficacy and safety of GMO vaccines for administration to humans”. More so, the applicant failed to establish he is “any other aggrieved person” within the meaning of s 147(1) of the Act. Without standing Fidge, ” ‘has no reasonable prospect of successfully prosecuting the proceeding’ within the meaning of s 31A(2)(b) of the FCA Act and r 26.01(1)(a) of the Rules”.
In her conclusion Rofe writes that instead of making an application under the “relevant statute that regulates vaccines”; the TG Act (as the AVN had done), Fidge “seeks an injunction under an act that only tangentially deals with GMO vaccines”. In what one imagines may well infuriate the legal brains who strategised this case in the wake of AVN, Rofe sensibly observes:
That strategic decision may be understandable in light of the decisions in AVN and AVN FC but was ultimately misguided.
Dr. Julian Fidge’s application for injunctive relief under the GTA was summarily dismissed. On 22 March 2024, Fidge filed with the Federal court for leave to appeal.
Is Justice Rofe corrupt?
Within a day of the ruling came the allegation, courtesy of Julian Gillespie, that Justice Rofe had failed to disclose prior activity as a barrister, representing Pfizer in patent disputes. There are five such instances that occurred between 2003 and 2006. There is no evidence Justice Rofe was unable to act impartially or did not act impartially. Nonetheless, PJ O’Brien & Associates and Ashby-Koppens have not only examined her career, but most of her life, her extended family and affiliates, to allege nefarious intention on her part motivated by “Big Pharmaceutical interests, both domestic and international”. They have filed a constitutional complaint with the Chief Justice of the Federal court and also called on the Australian Parliament to investigate allegations of misbehaviour, which if proven may result in her removal from the bench.
In the next post we will look into the complaint, the scope of its contention and ask not only if the allegation is justified, but even feasible.
On Monday 22 January 2024 the unique home for all things COVID conspiracy, Café Locked Out, hosted a video titled The Launch of OpenDAEN, A free database of Adverse Events. Cutting to the chase, OpenDEAN, promoted and launched by Sharon Cousins, purported to be an easy and honest means of access to the Therapeutic Goods Administration, Database of Adverse Event Notification.
Like its namesake previously debunked here, OpenVAERS, the Australian analogue of misleading information, OpenDAEN, presents decontextualised data in a manner that seeks to create the illusion COVID-19 vaccines are inherently unsafe. That “vaccine injuries” are rampant. Again like OpenVAERS it presents as conclusive fact, reports of negative health experiences observed in, or claimed by, an individual after that individual received a COVID-19 vaccine.
Like the TGA, OpenDAEN uses the Medical Dictionary for Regulatory Activities (MedDRA), to classify adverse reactions. It provides filtering with the European Medicines Agency, Important Medical Events list and Pfizer’s analysis of post authorisation adverse events. An additional adverse reaction of “serious” has been added to OpenDAEN. Sharon Cousins is an erstwhile insurance executive, now presenting as an “independent researcher” with a penchant for criticising COVID-19 vaccines. Sharon could not share her screen and was directing suspended NSW anaesthetist Paul Oosterhuis, the third member of this Zoom presentation, around the site.
The primary data interrogation categories on the index page of openDAEN are:
Case numbers by Year, Month and Sex
Cases by COVID-19 Vaccine Type
Case Numbers by Reaction term and Age
Case by Frequency of Batch Number
Table of case number, date, vaccine manufacturer, MedDRA reactions, Death, Serious cases and the FOI request number the batch number was confirmed by.
The index page offers the following:
Above: Slideshow: OpenDAEN website
OpenDAEN is called a “free database”. Don’t be fooled. The important elements here are reports and post vaccine, combined with the fact almost all adult Australians have had two COVID-19 vaccines, as have two thirds of 5-15 year olds. Random ill health events can and do frequently occur coincidentally with vaccination. It’s also important to realise that the TGA and health authorities encourage Australians to report these events, so that over time a greater understanding of these vaccines will emerge. OpenDAEN.info provides a description on each page footer:
OpenDAEN.Info is a non-commercial and not-for-profit website for the research, study and review of the TGA (Therapeutic Goods Administration) DAEN (Database of Adverse Event Notifications) system in respect of COVID-19 vaccines. The primary source of data on OpenDAEN is the TGA DAEN system and their published FOIs (Freedom of Information).
Decontextualisation
When taken out of context and denied TGA cautionary disclaimers, the reports become hearsay temporally related to something somebody did. Nothing more. This is decontextualisation. But apparently, we are to assume causation exists. OpenDAEN claims to be able to offer up to date, conclusive data related to adverse events caused by COVID-19 immunisation. These adverse reactions are the subject of reports sent to the TGA DAEN. So, the data themselves have a recognisable source. But can absolute conclusions be made with any real confidence? In reality it takes time for clinically relevant events, specific to any vaccination to be investigated, identified and acted upon. Unless already understood and published on the TGA COVID-19 Vaccine Safety Report (2 November 2023), the quality and quantity of adverse reaction is speculation. To make matters worse, the anti-vaccination lobby has invested an exceptional amount of time spreading disinformation via social media, and one of their primary targets has been the TGA DAEN.
The anti-vaccine lobby want every report to be an absolute reality. They want the figures, diligently and honestly provided to Australia by the TGA, to be accepted without examination as conclusive, in their misguided attempt to wipe out COVID-19 immunisation. We saw this claim time and again in the court affidavits of Peter Fam, Meryl Dorey, Julian Gillespie and Katie Ashby-Koppens; reports presented as if confirmation of death and injury in huge numbers. But correlation is not causation. If you haven’t clicked the link to DAEN by now, let’s see what the TGA, but not OpenDAEN, stress about the contents.
- DAEN SPLASH SCREEN DISCLAIMER –
Okay, so it confirms what I stressed above. But most crucially, you have to tick the teeny weeny little box next to I have read and understand the above, to access the TGA data. The disclaimer can’t be missed. Only willingly ignored. The importance of what this means and the restrictions the disclaimer places ipso facto, on OpenDAEN was studiously avoided during the video on 22 January. In fairness I will note that a small header on the TGA DAEN page was visible, but also ignored. It reads; Inclusion in DAEN – medicines does not mean that the adverse event has been confirmed or that it was caused by a medicine or vaccine. Clicking it – which the presenters also studiously avoided – reveals a little more about the DAEN content. Due to size restrictions of a screenshot, I’ll pop the text in a paragraph, and include some emphasis (mine):
The DAEN – medicines allows you to search adverse event reports for medicines including vaccines received by the TGA. The TGA uses adverse event reports to identify when a safety issue may be present. The DAEN – medicines does not contain all known safety information. An assessment of the safety of a medicine or vaccine cannot be made using the DAEN – medicines alone.
Talk to a health professional before starting, stopping, or changing your prescription medicines.
Anyone can report a suspected adverse event, including members of the public, health professionals and pharmaceutical companies. We encourage reporting even when it is not clear that a medicine or vaccine is the cause. Information from these reports is published in the DAEN – medicines and reflects the observations of the person who reported the event.
People who experienced an adverse event cannot be identified. Maintaining their privacy is of critical importance to the TGA.
The DAEN – medicines is a ‘living’ database that is frequently updated. Information may change if we receive more details on an existing report or if we identify duplicate reports and combine them. Updates may also occur as part of our data quality assurance activities.
In short, the TGA DAEN database is constantly growing, contains information from any member of the public, reflects the observations of that person, provides no information about the safety or lack thereof, of vaccines and does not confirm that an adverse event was caused by a vaccine. It cannot even confirm if the event has actually occurred. I might add, dear reader, given that the anti-vaccine lobby has gone out of its way to submit to the DAEN clearly impossible and even bogus reports, one must remain extra vigilant when assessing or querying these data.
Indeed, Sharon Cousins herself relayed an abuse of the TGA DAEN system at the 8:30 mark of the video. She had queried via FOI why a reported death of a 6 year old boy was no longer available on the DAEN. Sharon noted that within her FOI report FOI 4077 (“Batch numbers of COVID-19 vaccines of reported deaths”), it was revealed the initial report was submitted as a hoax. The relevant section of the report reads:
FOI 4077 also requested information about why case number 724925 no longer appears in the DAEN. This report was rejected following review of further information for the case. The information demonstrated that the report was submitted as a hoax and as such there is no identifiable patient. The report remains in the TGA’s internal database. However, it no longer is included in the DAEN as it has been rejected because it no longer met the minimum criteria for a valid adverse event report.
Sharon Cousins
Sharon also said the TGA reply included, “Normally we wouldn’t answer this”, after insinuating she has a positive relationship with them. However, that comment is clearly not there. One appreciates Sharon sharing this information, but cannot ignore that it took an FOI query of a fatality to uncover the truth. How many other adverse or serious adverse reactions were, or will be, “rejected following review of further information for the case”. Sharon was eager to reassure viewers that OpenDAEN was not misusing the TGA website, but rather making it “more user friendly”. It will be of benefit to TGA staff Sharon opined, and she had sent the site link “to the coroners”, and to State and Territory head pathologists.
Batch Numbers
Throughout, much is made of the section allowing search of batch numbers. We learn that when it comes to accessing batch numbers, the TGA, “Doesn’t have any search engines on it, is a little bit clunky and it times out”. The TGA freely provide data in CSV format on batch release assessment of COVID-19 vaccines. One of two release pathways is taken; either based on overseas certification or based on TGA laboratory assessment. The TGA explain this in detail. So, what could be wrong with smoother navigation of COVID-19 batch numbers as a function of vaccine type, reported adverse reaction and de-identified data? Usually nothing, unless one ignores TGA advice and extrapolates to conclusion, based on other available data.
At the 50:00 minute mark Sharon directs navigation through the number of cases per batch number, highlighting batch number FP1430 – COMIRNATY, (Pfizer), in section 4. OpenDAEN has accessed the batch numbers via FOI, and that’s fine. OpenDAEN reveals inordinately more adverse reactions for male and female associated with this batch number, compared to those next to it. Sharon instructed more data access and directed navigation to the batch number table. She continued:
Look at the dates! Look at all the dates! Within 24 hours of the Pfizer being released on the younger children, the five to elevens… it was all advertised, tenth of January [2022], five to eleven year olds… within 24 hours we have reported cases. Now that for me is causal proximity.
Sharon continued on, directing suspended doctor Oosterhuis to isolate reported – not confirmed – fatalities using that batch number and age group. They isolate two boys. Zeroing in on the symptoms of one boy, Sharon reads, abdominal pain, then dismisses adverse event following immunisation as “a very bland one”, then cardiac arrest. She has Paul Oosterhuis explain eosinophilia and eosinophilia myocarditis. He assumes he is explaining the findings of both of “these boys”. In fact the data reveal clearly it is only one boy. A five year old.
The ten year old “fatality” has only Adverse Event Following Immunisation listed. The “very bland one”, dear reader. Then Sharon warns us “It’s a little bit distressing now, okay. The two boys both had the same batch number”. She gets Oosterhuis to zoom in and suggests, “So, screen print that people if you don’t believe us”. After zooming in on the case numbers Sharon has Oosterhuis zoom in on the batch numbers again, as if she hadn’t made that point enough times already.
Now, I am not a lawyer but I doubt the strength of Sharon’s “causal proximity” claim. There is another factor Sharon told us herself, that must be considered. As she points out, the roll out for Pfizer for 5-11 year olds was 10 January 2022. Thus, the first factor I would investigate would be the sheer number of children being vaccinated, at the time of release. Over 11 weeks, 76.6% of those 2.3 million children were vaccinated. 1,761,800 children had one dose. 1,552,500 (67.5%) had two doses. The vaccine for 5-11 year olds is one third the dose approved for children aged 12 years and over. Cold chain transport and storage is vital to the success of mass mRNA vaccination programmes.
Using OpenDAEN to interrogate vaccine batch numbers of adverse reports about 5-11 year olds, over the first two months of the rollout, we see virtually one result: FP1430. Yet what is more likely? Batch FP1430 is responsible for all adverse reaction reports? Or most 5-11 year olds vaccinated in the initial days, were dosed from batch FP1430? By the end of February other batch numbers begin to appear and gradually attract more reports. By late March, FP1430 is just another batch number. More so, there are over 500 unknown batch numbers for that age group. However, if you present your disinformation just right, some might believe in the deliberate harming of children:
– Facebook comment –
What do the TGA say?
There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination. More detail on these deaths is available in the safety report published on 15 December 2022… If we identify a new death likely to be related to vaccination, we will publish this information promptly, as we have for all other cases since the start of the vaccine roll-out. [Source – 2 November 2023]
Of the 14 deaths the TGA confirm are linked to vaccination, none are in the 5-11 year age group. Yet Sharon is convinced of her claim, has already convinced others and will convince more, simply because of bias. Her defence, I suspect, will be that she used FOI legislation to access reports on batch numbers and the TGA lacks the smooth batch number access and navigation of OpenDAEN. Yet Sharon made up her mind before she even started looking. In fact, Inclusion in the DAEN does not mean the event has been confirmed or determined as related to a vaccine, is utterly ignored when using OpenDAEN.
The reactions reported in January, are based on MedDRA. Seen clearly in the video, were cough, vomiting, pallor, lethargy, rash, injection site rash, syncope, cold sweat, decreased appetite, anxiety, dizziness, nausea, abdominal pain, abdominal discomfort, aggravation of existing disease, excessive sweating, hives, muscle stiffness, chest discomfort. The worst on screen were seizure, appendicitis and a seperate loss of consciousness. Searching the batch number/adverse reaction table for 5-11 year olds in my own time, revealed reports of chest pain, syncope, anaphylactic reaction, paraesthesia, ECG ST segment elevation, nystagmus, pneumonia and many others. Some reports were of one reaction and others of multiple. All reports are of conditions children experience everywhere across the globe. Establishing cause or any relationship to COVID-19 vaccines is the role of health authorities.
Elsewhere on OpenDAEN we read that:
Useful search engines, graphs and tables have been developed into a helpful user-friendly database to assist study, research, review and analysis of the Australian Government publicly available data. […] We believe in sharing this information in an open and easy-to-use format (with search engines, tables and graphs etc.) and to help make it quicker for anyone wanting to source data for their own study, research and review.
The Quack Miranda
So, the team want to share information in a fast open and easy way to help with doing your own research. It sounds almost too good to be true. The Disclaimer and Disclosure tell us:
– Source: OpenDAEN –
Okay then. It is up to the user to get further professional information to confirm if the information is “of value to you”. Accuracy of the information cannot be guaranteed which places further responsibility on the user to seek advice before relying upon it. It’s information they might get wrong and as such will not be liable “for any loss, damage, cost or expense incurred” by reason of relying on that information.
It is 2024 and world search and data systems can perform enormous and complex requests with astonishing speed and accuracy, yet when Australian governments roll out never before used experimental gene therapies to millions of citizens, Australians are left to report to an antiquated adverse event reporting system (DAENs) still with both feet in last century.
This amounts to a fundamental failure of Pharmacovigilance and the Australian People. Searching through DAENs remains a nightmare for researchers, where one cannot but question the motivations of the TGA and the Australian health departments who feed it Our Information. OpenDAEN greatly assists researchers and students, and data and IT experts desperately needed to review and criticise the current DAEN system which is not fit for purpose.
Hopefully OpenDAEN will motivate Australian governments to take the needed steps towards a national real-time, transparent, and easily accessible adverse event reporting system, for properly protecting the health of Australians and better facilitating valid Informed Consent. The antiquated DAEN system deprives and seemingly hides needed health data necessary for Australians to provide valid Informed Consent.
COVID vaccine injury class action fund raiser, Dr. Melissa McCann writes:
This is amazing and meticulous work by you and your team.
Strong reminders of OpenVAERS and how decontextualised data are used by anti-vaccine activists to mislead, were apparent during the video. Alluding to what is known as the Lazarus Report, after the name of the principle investigator, one commenter offers:
– Facebook comment –
Suggesting that TGA DAEN statistics are only “(10%?)” of “ACTUAL injuries and deaths”, is linked to a bogus belief of widespread underreporting to VAERS in the USA. I addressed this in a post challenging OpenVAERS, writing.
The figure of 1% comes from a report from Harvard Pilgrim Health Care, Inc., authored by Ross Lazarus. Data examined are from 1 December 2007 to 30 September 2010. These data include all possible adverse events. Prior evaluation of the reporting rates of various events confirms that minor events are rarely reported and more serious events routinely reported. A 2014 report on surveillance of adverse events following immunisation in NSW, Australia noted that:
Only 11% of the reported adverse events were categorised as serious.
In short, most adverse events such as a sore arm, nausea, swelling, redness, headaches, vomiting and other self correcting issues are indeed underreported, but make up the vast bulk of adverse events following immunisation. Yet since the Lazarus report, anti-vaxxers love to spread tales of widespread death and terrifying injury, then solemnly add “only 1% are ever reported”.
Paul Offit is a strong supporter of VAERS which he refers to as a “hypothesis-generating mechanism”. Reports there of intussusception approximately once per 10,000 doses led to suspension of his own RotaShield vaccine which was ultimately recalled, before returning as a safe product. In fact health authorities want parents or doctors to report minor events as soon as possible. Much can be learned about self limiting reactions, and more concerning to severe reactions can be gauged by pattern changes, properly identified and suspended under section 29D of the Therapeutic Goods Act 1989.
Perhaps the most damning page on OpenDAEN is the resources page. A curated smattering of COVID-19 vaccine pseudoscience and “vaccine injury” class actions, peppered with all the anti-COVID mandate and health advice groups, it seems designed to lead readers into a field of gaping rabbit holes. Dr. Melissa McCann’s COVID class action vaccine injuries video tops the page. The World Council for Health Spike protein detox guide is there. R.F. Kennedy Jr.’s Children’s Health Defense Australia, The Zelenko Protocol, The Australian Medical Professionals Society, many of whom we’ve met here before, World of Wellness and the National Institute of Integrative Medicine to name a few.
Conclusion
OpenDAEN is not an exciting addition to the TGA DAEN database. It is not a positive, user-friendly addition to TGA staff or to genuine researchers and academics. It is created, managed, supported and provided by and for respectively, members of the anti-vaccine community, convinced that COVID-19 vaccines are the cause of multiple health ailments and death. No professionals were available for its launch. All invitations were ignored. It has no integrity and no academic standing. No coroners or State and Territory head pathologists will care.
Like its namesake in the USA, OpenVAERS, it is designed to allow users to gather misleading collections of coincidental report material and present this as causal COVID-19 vaccine adverse reactions. To be sure, the results it produces, easy to construct as they are, will find their way onto websites, social media and court affidavits. OpenDAEN won’t enjoy the success OpenVAERS did, because now only diehards remain. During the launch of OpeanDAEN, events two years old were focused on, to craft a demonstrably bogus, yet very serious accusation against COVID-19 vaccines.
Losing In The Lucky Country 