The Australian Babies Case: What was it? Why was it?

In a previous post we looked at the unsuccessful attempt of the Australian Vaccination-risks Network to convince the Federal Court of Australia it had legal standing to challenge the COVID-19 vaccine rollout.

They sought a writ of Mandamus to overturn provisional registration of mRNA and AstraZeneca COVID-19 vaccines, and a Judicial Review to overturn provisional approval of Pfizer’s vaccine for 5 to 11 year olds.

The evidence was intended to demonstrate lack of safety and efficacy of the vaccines. The plaintiffs contended the vaccines should not have been provisionally approved or registered. Indeed, that they should have been cancelled or suspended because of an imminent risk of death or serious injury. Thus, the Secretary of the Department of Health had erred in his duty to “cause to be maintained” the Australian Register of Therapeutic Goods.

However the evidence and legal arguments were never heard in court. The AVN had no “special interest”, and thus standing. On 8 August 2022 their appeal against this finding was found to be incompetent. A couple of months later, lengthy correspondence went out to all “donors and potential donors”. Headed AVN Legal Actions and Strategies the document opined on the issue of standing:

The way that the current case law is being applied by the Federal Court is essentially to say that nobody has sufficient standing to challenge these therapeutic ‘goods’, nor indeed the Secretary of Health.

The Babies Case

The AVN had decided to take “an alternative course of action”. One that had been researched and prepared by retired barrister Julian Gillespie and solicitors Peter Fam of Maat’s Method and Katie Ashby-Koppens of PJ O’Brien and Associates. In view of the AVN’s recent outcome it was deemed wiser to approach the High Court with “The Australian Babies Case” (AuBC), and seek to “halt the provisional approval of the Moderna jab from being injected into our precious 6 month old to 5 year old infants”. The AVN would “change course” and become a co-applicant with five others.

The other applicants were:

  • Associate Professor Peter Parry
  • Dr. Julian Fidge
  • Dr. Shoba Iyer
  • Dr. Astria Lefringhausen
  • Mark Neugebauer

The first three applicants above are active members of the Australian Medical Professionals’ Society (AMPS), a Red Union group that formed with the specific aim of challenging the rollout of COVID-19 vaccines, fighting COVID-19 mandates and promoting controversial treatments such as Ivermectin and hydroxychloroquine. Parry is also the lead applicant challenging the State of QLD over health professional’s vaccine requirements and a key member of Doctors Against Mandates. Three months before the AuBC strategy was outlined in this document, the AVN published the full AMPS Medico-Legal Summit on its website.

The breakdown of speakers at the summit includes AVN legal consultant and primary researcher behind the AuBC Julian Gillespie, primary plaintiff Prof. Peter Parry, Senator Malcolm Roberts and Senator Gerard Rennick. We will meet Senator Rennick again, later in this post. In lobbying the SA Minister for Child Protection, plaintiff Mark Neugebauer cites AMPS correspondence from Dr. Christopher Neil, another speaker at the summit. Gillespie and Ashby-Koppens appear on AMPS Discussions From The Frontline updating legal activity |2|.

The document went on to outline the strategy behind this new approach:

In The Australian Babies Case, the legal strategy is to present five applicants before the High Court of Australia, and show the Court how each applicant is affected by the actions and inactions of the Secretary of Health, with respect to the Covid-19 drugs made available to babies and young children, and the rest of the Australian community in circumstances where, prima facie, preventable deaths, illnesses, and injuries in extraordinary numbers are associated with their use; and where most of the population does not need them; however despite the expertise and evidence possessed by the various five applicants, the current law on standing in Australia is deficient, and will not recognise any of the applicants as proper parties for suing the Secretary of Health.

Australian Babies Case legal research team

It further outlined that the Babies Case would be seeking to have the High Court “fix the law on standing” such that the applicants would be accepted as having “special interest”. Namely, “the preservation of human life from preventable death, illness or injury”. It was claimed, albeit without evidence, these preventable outcomes were being seen now, due to “COVID-19 drugs” and that this constituted an “iatrogenic catastrophe”. That is to say, a catastrophe caused by the diagnosis and treatment of a condition.

Mark Robinson SC who represented the AVN in the initial failed case, confirmed this new approach was viable and advised that the High Court “has indicated that it wishes to revisit the law of standing in Australia”. They would be seeking:

  1. A new Special Interest regarding the preservation of human life.
  2. If successful, a court-granted injunction to halt the provisional approval of COVID-19 vaccines to babies 6 months to 5 years and children 6 to 11 years of age.
  3. If the High court recognises this new special interest for standing, that the High or Federal Court immediately hear the Judicial Review cases for both childhood age groups and the original Mandamus case for mRNA and AstraZeneca vaccines.

If successful, the AVN expected to be able to proceed with their initial cases. As “a matter of convenience” the AVN would seek to take over the running of the Judicial Review case that involved children 6 months to 5 years (the AuBC). The AVN note that they feel joining the case “operates as a de facto appeal” from the 8 August 2022 Federal Court appeal decision.

The application was filed with the High Court on 20 December 2022. The day before, a media release was published by AVN president Meryl Dorey. It provided some initial insight into the legal tactics to be employed in this quest for a new category of standing. Resurrected anti-vaccine themes from the initial Federal Court case peppered a quote attributed to Julian Gillespie (bold mine):

The High Court of Australia is now being called upon to protect our youngest from participating in an acknowledged and ongoing Phase III clinical trial, to receive experimental drugs involving unprecedented levels of reported adverse events, including deaths… for a virus also acknowledged to pose no threat to our Babies and Toddlers…

At this point it’s worth noting that, in public discourse, the Australian Babies Case legal team studiously avoid discussing the 3 August 2022 ATAGI recommendations for this age group. Namely:

ATAGI recommends COVID-19 vaccination for children aged 6 months to <5 years with severe immunocompromise, disability, and those who have complex and/or multiple health conditions which increase the risk of severe COVID-19.

More so, the legal team make much of the fact severe cases of COVID-19 are not common in this age group, and thus provisional approval of Spikevax suggests nefarious, and not clinical, motivation. Yet ATAGI clearly state:

ATAGI’s guidance takes into account:

  • The very low risk of severe COVID-19 (e.g. hospitalisation due to COVID-19) in healthy children aged 6 months to <5 years. This age group is one of the least likely age groups to require hospitalisation due to COVID-19. Among the small number who are hospitalised or who die due to COVID-19, underlying medical conditions or immunocompromise are frequently present. […]

The plaintiffs alleged Spikevax is a “genetically modified organism”. As such, Brendan Murphy, Secretary of the Department of Health had failed to comply with yet another section of the Therapeutic Goods Act 1989 (TG Act). As expected a writ of certiorari would be sought to quash provisional approval of Moderna’s Spikevax vaccine for children 6 months to 5 years. A writ of mandamus (where the court orders an official) was originally sought to have the application to approve Spikevax, reviewed under law. It was ultimately abandoned. For more specific insight we must turn to the application.

The plaintiff’s argument had two grounds, and a section headed Reasons Why Remittal Not Appropriate. Those reasons argued that the case should be heard by the High Court because that court had the power to accept the need for, and then admit for hearing, a new category of standing. Thus the High Court should not remit (send back) the case to the Federal Court. They contended that the principles for standing should be more liberal when a person can establish the subject matter involves life threatening or debilitating medical conditions and they seek to preserve human life. In short:

Where the fabric of human life might be compromised or adversely impacted, interested and involved members of the public should have a right of standing in such circumstances.

Whilst I don’t accept the argument for a new category of standing in this manner, I do agree that the law is frequently lacking. In fact, it’s about here I suspect a number of Australian vaccine proponents, Skeptics and opponents of the anti-vaccination lobby may feel a dash of Deja Vu.

In 2010, following complaints from the public about misleading AVN advice, the NSW Health Care Complaints Commission published a “damning report”. The AVN successfully appealed the ruling because whilst the HCCC had jurisdiction, the complaints lacked evidence that anyone had acted on AVN advice. The appeal outcome led to the Health Legislation Amendment Bill 2013 in NSW Parliament, allowing the HCCC to act on the likelihood of harm. A follow up inquiry was launched and a second, more in depth Public Warning against the AVN was published in 2014.

Let’s return to the present. The plaintiffs also argue that there are “important questions about the lawfulness of Commonwealth officials to make provisional determinations” that impact wellbeing. They allege there is no real jurisprudence about this in the context of the TG Act. Yet in reality, the standard of evidence required to make these determinations is high and the TG Act is comprehensively designed to minimise risk. Indeed failure to make provisional determinations may risk the wellbeing of the nation.

Ground One of the plaintiff’s argument again takes us to the TG Act. Specifically Section 22D(1), which provides that the Secretary must decide to make or refuse to make a determination, when a valid application has been made. In this case the application was for Spikevax (elasomeran), which the Secretary provisionally approved for children 6 months to 5 years, on 19 July 2022. The plaintiffs argue that s 22D(1) “is subject to an implied restraint”, that the decision will be legally reasonable. They submitted:

Legal reasonableness, or an absence of legal unreasonableness, is an essential element in the lawfulness of decision-making.

Referring to “the decision” to provisionally approve Spikevax for the ages under discussion, the application is dismissive of evidence used. It cites the TGA document Australian Public Assessment Report for Spikevax, 19 July 2022. Yet the Submission overview and risk/benefit assessment, accommodates no less than half of the 31 pages. This was updated on 8 November 2022; 42 days prior to filing of the plaintiff’s application, and contains 8 subsections covering 55 of the document’s 69 pages. Subsections include, but are not limited to, Quality, Risk management plan, Risk-benefit analysis, Additional clinical data and Second risk-benefit analysis.

The plaintiffs further argued that the Secretary’s decision that Regulation 10L(1)(a) of the Therapeutic Goods Regulations 1990 (TG Regs) was met, is legally unreasonable. That particular regulation states under Provisional Determinations:

(1) For the purposes of subsection 22D(2) of the Act, the criteria are all of the following: 

    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition;

In other words it was legally unreasonable to accept that the vaccine ever contributed to the prevention of serious illness brought on by COVID-19 in children 6 months to 5 years. This argument is a repeat of the AVN tactic seeking Judicial Review in the initial Federal Court Children Decision case, where they also targeted s 22D of the Act.

At the time I wrote:

This was cited because the AVN also sought an order quashing any determination made by the Secretary pursuant to section 22D, that an indication of the vaccine:

“[W]as the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition for children aged 5 to 11 years of age.”

The plaintiffs continue to argue their case for “legal unreasonable decision-making” by again turning to the TG Act. They argue the Secretary has failed to satisfy requirements in s 25(1)(d)(i). Section 25 deals with evaluation of therapeutic goods, and the cited subsection provides:

(d) for an application for provisional registration of a medicine

      (i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established.

Put more simply, the plaintiffs contend that when the Secretary was evaluating Spikevax, the data he used did not “satisfactorily establish” its safety and efficacy. This, they allege, amounts to legal unreasonable decision-making.

Genetically Modified Organism

Ground two of the plaintiff’s argument stated that the Secretary failed to comply with s 30C(2) of the TG Act. Section 30C provides for Consultation with the Gene Technology Regulator (OGTR). The cited subsection reads:

Subject to subsection (5), the Secretary must give written notice to the Gene Technology Regulator

      (a) stating that the application has been made; and 

      (b) requesting the Gene Technology Regulator to give advice about the application.

The affidavit continued:

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.

Could it be that the Secretary did not have to notify the OGTR? As fate would have it we are assisted here by questions from Senator Gerard Rennick. On 16 February 2023 during a Community Affairs Legislation Committee Estimates hearing, Rennick questioned our current gene technology regulator, Dr. Raj Bhula, about s 30C of the TG Act, asking if the Secretary had written to the OGTR in regards to mRNA vaccines.

You can read the full exchange on Rennick’s website, or watch the video of it below. However, I’ll cut to the responses that matter with respect to the AuBC. Does the Secretary have to notify the OGTR?

Dr Bhula : No, because the mRNA vaccines are not required to be regulated through the OGTR.

Senator RENNICK: Did they write to you and actually ask you that question?

Dr Bhula : No, because they’re not required to be regulated through the OGTR.

Senator RENNICK: But how would they know, because you’re the expert? And, by the way, gene technology involves both replication and transcription.

Dr Bhula : Yes.

Senator RENNICK: Which is what the mRNA vaccine does.

Dr Bhula : But the mRNA COVID-19 vaccines did not involve any step of genetic modification—

Senator RENNICK: They produce proteins.

Dr Bhula : or a GMO—

CHAIR: Senator Rennick, would you allow Dr Bhula to finish her answers.

Dr Bhula : which meant that that didn’t require regulatory oversight by the OGTR.

An unambiguous answer. Interestingly, this wasn’t published on Rennick’s website at the time of the exchange. It was published 20 March 2023, which was four days after the High Court decided not to hear the AuBC. A coincidence? Unlikely, dear reader. As mentioned above, Senator Rennick, the AuBC plaintiffs, key legal researcher for the case and the AMPS are linked by their COVID-19 ideology and related lobbyist activity.

Gerard Rennick questions Dr. Raj Bhula, Office of Gene Technology Regulator

For the purposes of the AuBC affidavit, I acknowledge the confusion surrounding mRNA vaccines and GM technology. The AstraZeneca COVID-19 vaccine using a genetically modified chimpanzee adenovirus, is a clear example of GM technology. The OGTR Risk Assessment and Risk Management Plan for that vaccine is here. Years earlier the OGTR published a similar plan for a GM Live Attenuated Influenza Vaccine. The TGA acknowledges both examples as GMO medicines.

Technology applied to extract, multiply and distill the mRNA used in vaccines to instruct our cells to produce the spike protein of SARS-CoV-2 is different to the genetic modification of an adenovirus or a live influenza virus. Dr. Bhula describes it as not involving “any step of genetic modification or a GMO”.

Nonetheless, the Australian National Gene Technology Scheme lists mRNA COVID-19 vaccines, including Spikevax, as GMOs used as medicines. An Open Access Government article states, “mRNA and viral vector vaccines are derived using techniques of genetic modification (GM)”. The Alliance For Science distinguishes between the two. “This one really is genetically engineered”, it says of the adenovirus vaccine, after discussing mRNA vaccines.

We must accept Dr. Bhula’s position that mRNA vaccines are not required to be regulated through the OGTR. For the sake of the AuBC affidavit, s 30C(2) of the TG Act does not then apply, and the provisional registration of the mRNA vaccine Spikevax, is valid.

Case Remitted to Federal Court

The plaintiffs did not appear before the High Court. On 16 March 2023, Justice Stephen Gageler remitted the case to the Federal Court of NSW, as per the following order. A summary page is below.

No weight was given to the legal arguments raised, although it was noted there were “supporting affidavits totalling more than 2,000 pages”. What’s important is Justice Gageler’s observation that the Secretary had submitted that the proceedings should be remitted to the Federal Court which would have jurisdiction, under Section 39B(1) or (1A)(c) of the Judiciary Act. That section follows parliamentary action in 1997, to transform the Federal Court into one with more general jurisdiction (see p.9), including jurisdiction over any matter, “arising under any laws made by the Parliament [excluding criminal implications]”.

Justice Gageler observed:

I am satisfied that this matter is one “arising under” the TG Act for purposes of s 39B(1A)(c) of the Judiciary Act, and that the Federal Court has jurisdiction over its subject-matter and the parties on that basis.

Justice Gageler reflected on the plaintiff’s claim that the High Court was the only appropriate Court to decide on a new category of standing due to “special interest” arising when “the fabric of human life might be compromised or adversely impacted”. He stressed that the power to remit is discretionary “to be exercised after due consideration of all the circumstances of the case”. Justice Gageler cited another case as instructive, in that the power of the remitter is designed to ensure the High Court is not diverted from its principle functions by matters that “could properly be brought in an Australian trial court”. After offering his assessment of the significant scale of the case, Gageler concludes:

Having regard to these considerations, significant case management and fact finding are likely to be required to conduct a hearing of the kind contemplated by the application. Undertaking that task would unduly divert the Court from its principal functions.

“We are Discontinuing the Australian Babies Case”

The plaintiffs did not return to the Federal Court. On 12 April 2023, instructing solicitor Peter Fam of Maat’s Method published an article, and a longer explanatory video, in which he labels the vaccines “a poison”. In view of their 2022 failures with the Federal Court, further chances were poor. Even if successful, there may be repeated appeals lasting over a year. They did not have the money or time. “People are being injured and dying every day”, from COVID-19 vaccines, Fam said without evidence.

Fam added; “Too much money has been used on facetious exploits and actions… things that haven’t been thought out in terms of strategy… people aren’t working together… doing things that are contradictory to each other… I have to take some responsibility… we lost the AVN case… a lot of money had been donated to that case”.

However:

All is not lost. This is a pivot; not a retreat, and there are other matters we have been working on simultaneously with this one, with better prospects of success than this case would have in the Federal Court. Those efforts will be formally launched within weeks, and you will hear more about them soon.

Dr. William Bay

A final mention must go to suspended GP registrar, William Bay. Bay has become a favourite amongst “cooker” watchers since he chose an AMA conference to film himself yelling anti-vaccine conspiracies, and call Chief Medical Officer, Paul Kelly “a liar”. A client of Peter Fam, Bay was asked to join the AuBC as a plaintiff. Shortly after he wanted to swap his position as plaintiff with the parent of a vaccine-injured child, believing this gave the team a greater chance at success. Fam and Gillespie disagreed. Nor could such a client be found.

Later, he filed for leave to intervene in the case as he objected to the nature of the special interest standing. He argued that if granted, the existence of standing granted via special interest in “the preservation of human life from preventable death, illness or injury”, could be used to justify COVID-19 vaccination for children. You can read Julian Gillespie’s “urgent” letter to supporters on this matter here.

Understandably, Bay further argues that such special interest standing may then be used to interfere in the application of medicine and the doctor-patient relationship in areas unrelated to COVID-19 vaccination (see video 56:45). Gillespie argues, quite rightly, that the request for standing applies to administrative and not private law. What Gillespie omits though, is any appreciation of how administrative changes impact private citizens.

Conclusion

The Australian Babies Case sought to convince the High Court to accept that medically qualified applicants had “special interest” preventing “death, illness or injury”, in babies and small children. Success would lead to a new category of standing, and this would permit the AVN to return to the Federal Court to pursue this case and its original 2022 Federal Court case, AVN v Secretary, Dept. Health.

Case evidence involved a revamping of prior legal tactics. The Therapeutic Goods Act was exploited by the plaintiffs to demonstrate regulatory failures on the part of the Secretary of the Department of Health. These failures, they again argue, justify overturning the registration or approval of COVID-19 vaccines. Driving this action was a suite of fallacious claims and misrepresented statistics.

The plaintiffs are members of and/or closely associated with the AMPS, a well organised union of medical and allied health professionals, working actively to undermine confidence in COVID-19 vaccines. Members of the legal team in this case are strident anti-vaccine activists, closely associated with AMPS, and outspoken anti-vaccine politicians.

Despite the label of “Babies Case”, this was all about giving the AVN a second chance for legal standing to have their case demanding an end to all COVID vaccines, heard in the Federal Court. Had standing been granted via a special interest as described above, it could be used to target all vaccines and help Meryl Dorey advance her life-long claim that “no vaccine is safe”.

According to the instructing solicitor of the AVN, further action should be expected soon.


Related material

Safety of COVID-19 mRNA Vaccination Among Young Children in the Vaccine Safety Datalink

Julian Gillespie and AVN fact checked

Julian Gillespie: AMPS Discussions from the frontline (Federal Court case)

Julian Gillespie and Katie Ashby-Koppens: AMPS Discussions from the frontline (Babies Case)

Peter Fam at COVID Inquiry 2.0 with Malcolm Roberts and Graig Kelly

Peter Fam on The Australian Babies Case

Julian Gillespie and Katie Ashby-Koppens discuss the AVN cases on Zerotime (32:10 mark)

A short grab on Twitter:


♠︎ ♠︎ ♠︎ ♠︎

Last update: 11 July 2023

Dr. Rima Laibow, “the great culling” and colloidal silver

The COVID pandemic gave voice to a number of conspiracy theories that sought to offer an explanation about what was “really” happening. Some of the more bizarre, and yet persistent, conspiracies involve an inexplicable plan of global depopulation. Or as it is often labelled, “culling”.

A decade before the pandemic, anti-vaccine conspiracy theorists had accused Bill Gates of using vaccines in his own quest to depopulate the planet. That was an intentional distortion of a TED talk Gates had given in which he notes that improved public health correlated with decreased population growth. Over time it became a particularly robust piece of misinformation, commonly spread with the unfounded claim that vaccines cause infertility. Claims of vaccine induced depopulation and infertility found new ground during the pandemic. As the pandemic continued a host of conspiracy theories about vaccines were entertained by antivaxxers in a bizarre ebb and flow fashion modulated by social media.

Another identity associated with the depopulation conspiracy theory to be dusted off during the pandemic was psychiatrist, Dr. Rima Laibow. Rima was referenced on social media in 2021, January 2022 and most recently in March 2023. Laibow’s attraction was due to her appearance on the 2009 programme Conspiracy Theory with Jesse Ventura. Motivated by H1N1 (“Swineflu”), anti-vaccine conspiracy theory rhetoric, Laibow claimed during an interview that the World Health Organisation had been working since 1974 to orchestrate global depopulation. She claimed the WHO assessed the world overpopulated by 90% and was using vaccines to create “permanent sterility”. That the population had grown from 4 billion to just under 7 billion from 1974 to 2009 was seemingly lost on her.

April 2023 Instagram post from a now deleted account

Her 2009 appearance with Jesse Ventura was being shared on social media along with commentary suggesting that Laibow had “nailed it” and foreseen both mandatory vaccination and “the great culling“. In the histrionics of conspiracy theory echo chambers this was proof that the WHO was using COVID-19 vaccines to create permanent sterility, and that Laibow had “cautioned us against COVID-19”. It must be stressed that mandatory vaccination either for H1N1 or COVID-19 never eventuated. There has been ample controversy regarding vaccine mandates in certain workplaces during the COVID-19 pandemic, but in no way have Laibow’s claims been realised.

On 26 April 2022 Health Feedback published a fact check of another of Laibow’s accusations in the video. Namely, the claim that squalene in vaccines caused autoimmune disease and Gulf War Syndrome. Unsurprisingly, the verdict was “inaccurate”. Laibow warned of the horror vaccines would unleash, telling Jesse Ventura, “What that means is a genocidal holocaust. Men and women will sicken and die and those who survive will be infertile”. The YouTube video below contains the circulating clip of Rima Laibow, edited to educate the viewer as to Laibow’s relationship with science, the truth and legislation.

Dr. Rima Laibow

Selling Colloidal Silver

During her interview Laibow dramatically remains on the edge of a tarmac lest she need to suddenly escape from the USA to avoid “compulsory vaccination” for H1N1. She did not feel safe living in the USA and tells Ventura she was leaving as soon as the interview was over. However, it appears she managed to overcome her fear to work as “medical director” and trustee of the company, Natural Solutions Foundation, with a website hosted at drrimatruthreports.com. By 2014 Rima Laibow was selling a “cure” for Ebola. The “cure” was 10 PPM Nano Silver, which was in fact colloidal silver, and packaged as “Dr. Rima Recommends Nano Silver”. In September 2014 the US Food and Drug Administration and the Federal Trade Commission labelled the company “scammers”. A warning letter to the company informed Laibow and a co-trustee that they were in breach of the Federal Food, Drug and Cosmetic Act (FDCA).

The correspondence includes examples of strikingly inaccurate claims made on the Natural Solutions Foundation website in which nano silver is described as “safe and non toxic… able to kill every pathogen worldwide against which it has been tested”. Health authorities were of course hiding the truth of this cure and the absence of “declassified research” supporting colloidal silver was proof it is effective. Packaged with a CBD organic chocolate bar, nano silver constituted part of a “protection pack”. Other claims included:

Conventional Antibiotics won’t do much against genetically engineered or resistant organisms… But safe, gentle and effective nano silver kills disease organisms in a different way… This is powerful natural protection you need for yourself ad [sic] your family. Choose the Personal Protection Pack or the Family Protection Pack…

It kills only the organisms that cause disease… similar to the lamps in hospitals that kill deadly germs… and also interferes with the metabolism of the disease organisms in such a way that they cannot become resistant to it. 

Laibow responded by altering claims made on the company website. The scheme was heavily criticised on the 7 On Your Side TV programme “Don’t Get Taken By Ebola Scams”, in which Laibow reportedly argued the scam label was “ridiculous”. Ebola scams were common in the USA at the time, taking the form of bogus charities and cures. Ebola cases and deaths had occurred on US soil and scam artists were taking advantage of fear and uncertainty.

By 2020 of course, the pandemic was upon us. Did Rima Laibow actually turn to reminding us that she had warned of the WHO depopulation-by-sterilisation using vaccines? Did she flee the US in fear of mandatory vaccination? Well no, because Natural Solutions Foundation immediately got to work selling the very same Nano Silver concoction as a treatment for COVID-19. At the same time COVID conspiracy theories were peddled via the long standing Dr. Rima Truth Reports, and went as far as calling face masks “mind control devices”.

Ultimately, the FDA filed a suit on 13 November 2020 that alleged Natural Solutions Foundation, and its trustees Rima Laibow and Ralph Fucetola, had “sold and distributed a nano silver product that the defendants claim will cure, mitigate, treat, or prevent COVID-19.” It further alleged that they had sold misbranded drugs, as labelling for use was insufficient. As such they had violated the FDCA, and on 28 December 2021 were ordered by a District court to stop distributing the colloidal silver. This was the same product used in breach of the same Act as in 2014, albeit now in exploitation of COVID-19.

‘Dr. Rima Recommends’ nano silver label

Fortunately, this time the outcome was more enduring. The defendants agreed to settle the suit and be bound by a Consent Decree of Permanent Injunction [PDF]. The court entered an order that enjoins the defendants from violating the FDCA. They were ordered to recall all nano silver products sold from 22 January 2020 to 27 December 2021, and destroy any such products in their possession. Before distribution of any drugs in future they must notify the FDA in advance, comply with remedial measures and permit an FDA inspection of their facility and procedures. On 8 March 2023 the FDA published an urgent product recall from the company for the nano silver product, issued as part of the consent decree.

These days Dr. Rima Laibow and Ralph Fucetola of Natural Solutions appear on Open Source Truth [archive] and present a weekly podcast titled The Unmasked Crusaders. The Natural Solutions Foundation website is unchanged from a decade ago and the Dr. Rima Truth Reports continue. They do not, thankfully, sell colloidal silver.

The anti-vaccine, anti-mask, anti-science rhetoric however, is undiminished.


♠︎ ♠︎ ♠︎ ♠︎

Monica Smit ABC interview: inaccurate, harmful, offensive say Audience and Consumer Affairs

Following a complaint to the ABC in the wake of a 12 August interview with the founder of Reignite Democracy Australia, Monica Smit, Audience and Consumer Affairs concluded that it was a “serious editorial misjudgement”.

They found that ABC Far North Drive breached the ABC’s editorial standards for accuracy, harm and offence. A correction has been published and, after the finding is reported to the ABC board, it will be published under upheld complaints.

A post here on 18 August, examined in depth a series of bogus claims made by Smit (pictured), and touched on the importance of editorial accuracy. On 13 August I’d submitted a complaint to the ABC summarising the most significant points made in that post.

As mentioned in the post under Editorial Standards?, after the interview, presenter Adam Stephens did clearly outline his reasons for having Smit on. He thought it is interesting people hold such views and that, as evidenced by RDA pamphlet drops, some residents around Cairns had been swayed by Smit.

He also added:

Whether you wanted to hear from Monica or not there are people that are listening to her message, and sometimes it’s… I think worthwhile in actually learning about the motivations of some of these groups in our community, and some of the people that feel strongly enough to actually join groups like this and distribute their information.

This sounds reasonable, but the problem is that Smit is a skilled manipulator. She is well versed in faux justifications for anti-vaccine, anti-mask and anti-lockdown claims. The RDA site leaves no doubt that they present harmful and divisive claims backed up by legal loopholes and the misrepresentation of studies. At the time, Smit had already incited a number of illegal protests. It was clear she had no regard for community safety. It is a factor that ABC management should have proactively made clear to programme producers across the country.

In an ideal world, disinformation would be refuted on the spot. In reality, because Smit (and others like her) cover such a range of topics, and use obscure details, this is impossible. The answer is to never provide air time. A decade ago, anti-vaccination activist Meryl Dorey was given ABC air time to discuss an immunisation incentive. She used both opportunities to spread disinformation. Complaints were upheld and Dorey hasn’t been on the ABC since. Let’s hope a similar fate awaits Smit.

The correction published by the ABC is as follows:

ABC Far North: On 12 August, ABC Local Radio Far North Drive interviewed a member of anti-lockdown and COVID-19 conspiracy group Reignite Democracy Australia (RDA). The program failed to explain that the interviewee had no medical or pandemic expertise; and that the group is anti-lockdown, anti-vaccination and encourages illegal lockdown protests. This context was material to the audience’s understanding of the issues to hand. During the interview it was stated that mask wearing is dangerous; this is inaccurate. The interviewee made repeated erroneous claims about important public health matters which were not adequately contextualised or corrected by the presenter. The program failed to take the opportunity after the interview to directly correct and debunk the claims made.

ABC’s editorial standards are covered in the Code of Practice. Ultimately, Audience and Consumer Affairs found that the interview breached the ABC standards for accuracy 2.1 and 2.2, and for harm and offence 7.1 and 7.6. The full email response from Audience and Consumer Affairs is below (with permission of ABC).

Dear Mr Gallagher

Thank you for your email regarding the 12 August edition of ABC Far North’s Drive with Adam Stephen, which featured an interview with Monica Smit of Reignite Democracy Australia (RDA). I apologise for the delay in responding.

Your complaint has been considered by Audience and Consumer Affairs, a unit which is separate to and independent of content making areas within the ABC. Our role is to review and, where appropriate, investigate complaints alleging that ABC content has breached the ABC’s editorial standards, which are explained in our Code of Practice. We have carefully considered your complaint, sought information from ABC Regional management and assessed the content against the ABC’s editorial standards for accuracy and harm and offence

Drive has explained that local Cairns businesses had received flyers from RDA, and that they broadcast an interview with a business owner who expressed his frustration with the “irresponsible” behaviour of this group which would “put everyone else in danger”. Following this, the editorial decision was made to interview Monica Smit from RDA.

Audience and Consumer Affairs have concluded that within the context presented, this interview was a serious editorial misjudgement. Our findings are set out below against the relevant editorial standards.

Accuracy

2.1 Make reasonable efforts to ensure that material facts are accurate and presented in context.

2.2 Do not present factual content in a way that will materially mislead the audience. In some cases, this may require appropriate labels or other explanatory information.

As you explain, at no point was it made clear that Monica Smit and RDA have no medical or pandemic expertise, nor are they advised by medical experts. It was not made clear that their flyer and website provides no reputable or evidence-based information. Further, it was not explained that RDA is an anti-lockdown, anti-vaccination activist group which attends, supports and encourages illegal lockdown protests and other activities. This context was material to the audience’s understanding of the issues to hand and in particular to the credibility of the claims made by Monica Smit.

As you point out, Monica Smit made numerous inaccurate and unsupported statements in this interview which were not corrected or adequately challenged by the presenter. The claims made by Monica Smit regarding mask wearing and lockdowns were both alarming and erroneous. The interviewee was allowed to make repeated inaccurate claims about important public health matters which were not adequately contextualised or corrected. Further, the program failed to take the opportunity after the interview to directly correct and debunk the claims made.

Audience and Consumer Affairs have concluded that Drive breached the ABC’s editorial standards for accuracy 2.1 and 2.2.

Harm and offence

7.1 Content that is likely to cause harm or offence must be justified by the editorial context.

7.6 Where there is editorial justification for content which may lead to dangerous imitation or exacerbate serious threats to individual or public health, safety or welfare, take appropriate steps to mitigate those risks, particularly by taking care with how content is expressed or presented.

Audience and Consumer Affairs observe that reliance by listeners on the information provided by Monica Smit during this interview about public health orders was likely to cause harm. This includes the inaccurate information about mask wearing, lock downs and comments made by the interviewee on how to breach / avoid health orders.

The likely harm was not justified by the editorial context. Issues around groups like RDA are newsworthy to a degree, usually because of the threat or harm they present to the wider community and their illegal activities. An interview with a fringe activist with no medical expertise talking about public health matters requires very solid context and rigorous debunking; that did not happen on this occasion.  

The material propagated by Monica Smit in this interview put RDA followers and the people around them at risk, and the editorial context did not justify the likely harm. The program did not take adequate care with how this content was expressed or presented, particularly in relation to accuracy. 

Audience and Consumer Affairs have concluded that Drive breached the ABC’s editorial standards for harm and offence 7.1 and 7.6.

ABC Regional apologise for this serious lapse in editorial standards. This matter has been discussed with the program team and a correction published here. In keeping with Audience and Consumer Affairs’ usual processes, this finding will be reported to the ABC Board and a summary published here

Thank you again for bringing your concerns to the attention of the ABC. Once again I apologise for the delay in responding. Should you be dissatisfied with this response, you may be able to pursue your complaint with the Australian Communications and Media Authority (www.acma.gov.au).

Yours sincerely
(redacted)
Investigations Manager
Audience and Consumer Affairs


♠︎ ♠︎ ♠︎ ♠︎

Chiropractor Simon Floreani Suspended: Lessons Learned

Fundamentalist chiropractor and career anti-vaccination activist Simon Floreani, was last week suspended from practice for six months, from 18 October 2021.

The Victorian Civil and Administrative Tribunal (VCAT) handed down the ruling [Archived] after Floreani was referred by the Chiropractic Board of Australia (the Board) in March 2019, for professional misconduct. In November 2016 Floreani featured in a video podcast interview titled Nazi Vaccination Regime in Australia. In December 2016 Floreani facilitated the screening of Andrew Wakefield’s anti-vaccine film Vaxxed: From Cover-Up to Catastrophe at his chiropractic clinic. Not surprisingly the film’s thoroughly debunked theme and content are, “contrary to the Chiropractic Board of Australia’s codes and statements”.

Floreani was initially suspended on 27 September 2017, after an Immediate Action Committee (IAC) was convened. The transcript informs [item 5]:

The IAC made that decision on the basis it formed the reasonable belief that action was necessary because Dr Floreani posed a serious risk to persons and it was necessary for it to take immediate action to protect public health and safety.

That suspension lasted around six weeks as it was stayed by the VCAT. Conditions were imposed in March 2018 [item 142], and have applied since then. The Tribunal accepts Floreani has complied with them. The matter had returned to the Tribunal, “because the Board decided it was appropriate to refer Dr Floreani so the Tribunal could consider making disciplinary determinations.” [item 8].

The conditions, designed to limit Floreani’s anti-vaccination influence when he returns to practise, will be in place for twelve months. These include a ban on anti-vaccination signage, materials, advice to practice clientele, and “public comment discouraging vaccination”. If asked about vaccination by a client, Floreani must refer them to an appropriate practitioner. These are an effective continuation of conditions imposed by VCAT in 2018 and “there is no dispute Dr Floreani has complied with them in full at all times”. There is another pre-existing condition (noted item 178) that will also continue. Floreani must display the following sign in all waiting areas.

Please be advised Dr Simon Floreani does not provide any patient with advice regarding vaccination. Any patient requesting such advice will be referred to an appropriately qualified medical practitioner

He must permit the Australian Health Practitioner Regulation Agency (AHPRA) access to waiting areas during business hours, to monitor compliance with signage. Floreani must also submit to practice inspections during which AHPRA may access appointment diaries, booking schedules and any social media accounts used in conducting his business. AHPRA will provide a minimum of 24 hours notice before these inspections, and not conduct them more frequently than once per calendar month. Despite this, they are referred to as “random practice inspections”.

One reads:

The respondent must bear his own costs of complying with the above conditions.

The videoed interview Nazi Vaccination Regime in Australia was with US based anti-vaccine conspiracy theorist and chiropractor Billy DeMoss. During the 3 November 2016 interview Floreani suggested that “they” are trying to silence screening of Vaxxed in Victoria and because people “have to have secret screenings”, it was “a nanny state”. He went on to make some extraordinary statements such as:

…we could not find one shred of evidence to show the efficacy of childhood vaccination […]

I’m, under my regulation and registration requirements, not allowed to talk about vaccination. But under the laws of this country I have to do what’s right… I have to tell people the truth, as a health practitioner, as a leader, as a father, as a community member […]

…parents are trusting their gut and saying, “I don’t want to do this. I can’t inject this poison in my baby’s body and be okay with that” […]

…the evidence is not there to suggest that people are safe and our kids are safe

Prior to 10 December 2016, Floreani was contacted by then president of the anti-vaccine pressure group, Australian Vaccination-risks Network (AVN)*, Tasha David. She requested he screen the film Vaxxed at his clinic. Floreani and his wife, anti-vaccine author and chiropractor, Jennifer Barham-Floreani are past professional members of the AVN. The screening at his clinic was one of a number the AVN had organised at the time. The event was covered in depth, including a video of the entire evening, by reasonable hank. Glaringly obvious, but important from a legal standpoint, the Tribunal has observed that prior to the screening, “Floreani was aware of the content of the film”. Indeed.

Both allegations, which are detailed in the ruling transcript, are that Floreani engaged in professional misconduct and unprofessional conduct. Both allegations note that he:

(i) failed to promote the health of the community through disease prevention and/or control; and/or 

(ii) failed to provide balanced, unbiased and evidence-based information to the public; and/or

(iii) promoted and/or provided materials, information or advice that was anti-vaccination in nature and/or made public comments discouraging vaccination.

That sounds like the Simon Floreani I’m familiar with. His transgressions in the above regard range far further afield than those covered in the Tribunal ruling. This is reflected in item 197 of the transcript:

The Board submitted the admitted conduct represented ‘repeated brazen departures from the standards expected of a registered chiropractor’.

This may be a statement about Simon Floreani. However, in that it describes his stance on vaccination, it confirms that similar views held by a large number of practicing chiropractors are therefore well removed from “standards expected of a registered chiropractor”. The problem is one inherent in chiropractic, although I rush to add it is not absolute in chiropractic nor exclusive to chiropractic. The re-emergence of vitalism in chiropractic has led to an influx of practitioners who almost certainly began the study of chiropractic with an established aversion to evidence-based medicine. Once qualified, they see themselves as representatives of a viable alternative to the medical profession if not a replacement for it. This is a problem of staggering proportions and one that the Chiropractic Board of Australia is seemingly ill equipped to address.

A unique example emerges when considering the transcript of the VCAT hearing. As noted there’s no dispute about Floreani’s compliance with conditions initially imposed in November 2017 [item 144]. As we read in item 150 the Board considered another notification about Floreani in 2019. It was received by the Board in 2017, and concerned conduct from 2016. The Board decided to investigate in May 2017, concluding on 26 July 2019. The professional conduct issue related to items published by Floreani on Facebook and his business website. He made claims about the effectiveness of chiropractic for conditions and circumstances, in the absence of any evidence. Namely [item 151]:

(a) Chiropractic care for childhood illness, colic, ADHD, autism, cerebral palsy and asthma;

(b) Chiropractic care to treat infants who are having trouble sleeping or have persistent ear infections or reflux;

(c) Suggesting homeopathy could be used in lieu of traditional vaccines; and

(d) Suggesting that conventional medicine was ‘poorly performing’.

The transcript tells us the investigation lasted twenty six months. Twenty one months in, on 20 February 2019, Floreani appeared on A Current Affair defending the actions of Andrew Arnold who was filmed the previous August performing a series of non-evidence based adjustments on a two week old infant. Floreani told ACA:

I’ve been doing this 20 years, and the proportion of paediatric patients has gone from one in 10 to three or four in 10.

The next day Arnold was put on an undertaking by the Chiropractic Board, published on his website, that he would not treat children from birth to twelve years or provide any material in support of such treatment on any internet platform. It’s inconceivable that Floreani was not aware of the Board’s ongoing investigation into his advertising. He chose to publicly defend Arnold despite the highly controversial and widely reported circumstances.

Ultimately the Board found that his 2016 performance was unsatisfactory and below the expected standard. He failed to work “within the limits of his competence and scope” and failed to comply with the Board’s Statement on Advertising. After AHPRA requested removal of the material it was removed in full. The transcript observed that this was said to demonstrate, some level of insight and compliance by Dr Floreani in relation to his advertising”. Floreani had already been cautioned in 2014 for provision of anti-vaccine material (see below). In response to the evidence-free claims above, which are anything but unique in chiropractic advertising, the Board cautioned:

The practitioner is cautioned in relation to the publishing of advertising and other material in relation to chiropractic care that is not supported by sufficient evidence.

One should acknowledge that this is seperate from the career antivaccinationist activity Simon Floreani is known for. Perhaps the record of compliance with conditions and the evidence he gave does support him having turned a corner. Perhaps. We can get an idea of his prior and current vaccination beliefs by revisiting his comments about his wife’s book, Well Adjusted Babies, both during the DeMoss interview and when giving evidence. Item 65 contains longer responses of Floreani’s from the DeMoss interview. During these he clearly relies on the book as a source of “evidence” and “research”. He talks about working with the regulator to show them “evidence”. He tells DeMoss his wife had been snowed under and produced:

18 reams of paper worth of evidence and research around every single question they asked […]

…and you give these people what they want. When they want evidence, you know, there is – we could not find one shred of evidence to show the efficacy of childhood vaccination.

This is only twenty eight months after the Board had cautioned Floreani for providing Australian Vaccination-risks Network booklets in his waiting room. It was submitted to Tribunal by Marion Isobel, counsel for the Board, that he had done so despite being aware that the Board had that year, “released a communique requesting practitioners to remove all anti-vaccination material from their websites and clinics” [item 202]. On 22 July 2014 the Board advised of the caution. It was as follows [item 148]:

The Chiropractic Board of Australia cautions Dr Floreani that in the future he ensures that he is familiar with and complies with the Board’s guidelines for the advertising of regulated health services.

Returning to Floreani’s chat with DeMoss, the transcript includes:

And, you know, really the evidence is not there to suggest that people are safe and our kids are safe, and it’s a really – you know, my wife, God bless her, has worked tirelessly to bring the evidence together, and her next book will be – you know, we’ve got this multimedia platform where we can share the research as it becomes available, in layman’s terms, to help people actually hear the truth, not through the media but through multimedia platforms. We can share around the world exactly what the truth is, exactly what the research says and let people make informed decisions…

This confirms the level of disinformation Floreani and his wife were content to disseminate through various media. Indeed VCAT and the Chiropractic Board of Australia are limited to Floreani’s conduct as a chiropractor, or activity demonstrated to be in a professional capacity. Well Adjusted Babies was published through the group Well Adjusted Pty Ltd. Floreani and his wife are the shareholders and Floreani’s son is the director [item 64].

In evidence, Floreani confirmed he had been active in the company as a “research assistant” and currently has no role. He maintained he does not promote the book Well Adjusted Babies. Dr. Ann Koehler [item 41] gave expert evidence to the Tribunal, including the risks associated with statements made in the book’s chapter on vaccination; chapter 15. She quoted the preface to this chapter [item 70]:

Laying aside the very real possibility that various vaccines are contaminated with animal viruses and may cause serious illness later in life (multiple sclerosis, cancer, leukaemia, ‘Mad Cow’s’ disease, etc) we must consider whether the vaccines really work for the intended purpose.

Regarding his role in development of the book Floreani said he, “helped distil information into lay terms” [item 187]. Perhaps the above paragraph reflects his prior, and not his current stance on vaccination. Or, perhaps not. Giving evidence, Floreani was asked if he stood by the content of chapter 15. He referred to the book as “an evidence-based document”. Dr. Koehler stated that the content was “inaccurate, misleading and alarmist”. Floreani disagreed. In fact it wasn’t something he wanted to discuss because the Tribunal was not “workshopping the book”. Asked how he would describe the content of chapter 15:

He said again it was an evidence-based document which was ‘up for discussion’ as was all research information. He said he was not in that arena and did not deal with that kind of material and was not prepared to ‘walk down that path’.

When asked if he still held the same views on vaccination but had agreed to not make public statements, Floreani replied that he was “a researcher at heart and a critical thinker” [item 189].

He said he would appraise any information and he was not fixed in his views. He said he was ‘very prepared to take [his] medicine’. He then stated that he understood that, in the whole area of vaccination, there were ‘diverse opinions’.

In addition, Floreani’s current curriculum vitae lists him as a “contributor” to Well Adjusted Babies 2005, Well Adjusted Babies Revised Edition 2006, Well Adjusted Babies 2nd Edition 2009 Vitality Productions and Well Adjusted Babies Practitioner Guide 2009 Vitality Productions [item 166]. The antivaccinationist in Simon Floreani is an ingrained part of his identity. His C.V. reflects that he is not only happy to be seen as having promoted anti-vaccination views but is proud of it.

Reading the transcript, it’s tempting to accept he is motivated to keep an anti-vaccine image out of his professional life. Yet even this purported change isn’t something that evolved. He has been forced into this position after repeated breaches of the Chiropractic Code and/or Statement. To use his own words he feels he has been “bludgeoned about the head” [item 185].

He was no doubt also motivated to avoid a suspension and, having already been suspended in 2017 by the IAC for the same matter, was aware the Board would seek another. Reading through the transcript it isn’t surprising that the Tribunal agreed one was warranted. Particularly in light of his entrenched views outlined above, which is reflected in item 14:

However we remained concerned that his statements to us showed he has not fully absorbed relevant Code obligations and he appeared to maintain a level of scepticism about vaccination.

Under Dr Floreani’s submissions on determinations, the transcript noted via his counsel, Mr. Shaun Maloney, that Floreani agreed a reprimand was an appropriate order [item 204]. Also, that written submissions “contended that a suspension was wholly unsustainable in this case and was in fact a punishment” [item 205]. It’s further contended that suspensions are reserved for protection of the public and to ensure the practitioner gains insight and ‘the message’. “None of those matters are present here”, it was submitted.

Other noteworthy points from submissions include [item 205]:

Dr Floreani has full insight. […] He is apologetic and has recanted. […] The risk of repetition is non-existent. […] This is a health practitioner who has committed isolated error for which he is truly sorry… […] …the only possible justification for a suspension is as a matter of general deterrence. […] It is illusory to suggest that general deterrence is necessary here… […] …seen in the light of that which it truly is, being an isolated act, made in error through a transitory erroneous opinion… […] Accordingly, any period of suspension is not warranted for protection of the public, either for specific deterrence or for general deterrence.

Clearly the Tribunal did not accept the argument from submissions. I also found the source and content of references for Floreani compelling [item 168]. Not one referee stated a clear purpose for the reference nor indicated they were aware of the VCAT proceedings or Floreani’s involvement with the Board. One name leaps out immediately. That of Canadian chiropractor Elizabeth Anderson-Peacock, who in 2019 lost re-election for her seat on the executive of the College of Chiropractors of Ontario (CCO). The National Post reported this was in the wake of speaking at a conference that also hosted Del Bigtree. Earlier that year she had endorsed Vaxxed – the same movie Floreani now faced disciplinary action for permitting to be screened at his clinic. The reference was dated 22 June 2021.

The Tribunal didn’t refer to this thumbing of the nose at proceedings from Floreani, but did provide a quoted section from Anderson-Peacock’s reference which they were “very concerned by”. It included in part [item 172]:

On occasion that [ensuring clients can make a fully informed decision] sometimes includes inconvenient or alternative viewpoints from mainstream allopathy. Dr Floreani encourages people to do their own research and think.

Another, dated 7 June 2021, referee is Mr Giles A. La Marche, Vice President of University Advancement and Enrolment, Life University Canada. On 13 April 2020 BuzzFeed News published Chiropractors Are Feeding Their Patients Fake Information About The Coronavirus. A paragraph was devoted to La Marche who, on April 10, had then shared a conspiracy video about Bill Gates’ plan to depopulate the planet with COVID-19 and articles on how Fauci was planning to profit from a COVID-19 vaccine. On 21 May 2021 La Marche featured in The Atlanta Journal-Constitution after posting a story from the antivax disinformation mill Children’s Health Defense on a purported COVID-19 vaccine death.

Floreani referee likens Hitler to free thinking scientists

More recently on 27 September this year La Marche posted a video on his Facebook page, Canadian doctors destroy the COVID-19 fear narrative. On 7 September he shared “important info” on “jaw dropping mask and vaccine failures”. He’s also just bought Robert F. Kennedy, Jr.’s book, The Real Anthony Fauci. On 30 August he wished someone a happy birthday. Smiling from the accompanying photo is one Billy DeMoss who hosted the Nazi Vaccination Regime in Australia podcast – the same podcast Floreani now faced disciplinary action for airing his anti-vaccination laundry on.

Eric Russell, past president of the New Zealand college of chiropractic is devoted to the promotion of vitalism in chiropractic and “subluxation-based research”. He has spoken of chiropractors going into the world to help humanity and the chiropractic philosophy. In 2009 he was inducted into Palmer College of Chiropractic’s Great Hall of Philosophers. At last year’s Parker seminar he spoke about chiropractic philosophy and how this shapes Wellness past, present and future.

In an undated reference chiropractor Kimberlie Furness praised Floreani, having been impressed by him almost twenty years ago. He had worked on infants, toddlers and children. The transcript observed [item 174]:

She referred to his practice being evidence-based, combining the ‘best available research evidence with clinical judgement and patient preference’.

The Tribunal observed it’s often inappropriate to present references from clients “given the uneven power dynamic between practitioner and patient” [item 171]. However they did note that Ms. Andrea Pavleka “senior executive, legal practitioner” [item 168], was positive about professional treatment received and personal qualities of Floreani.

Looking at these references it is far from surprising that the Tribunal observed:

Taken as a whole, the references did not show the authors were aware of the content of the Allegations or the nature of the Tribunal proceeding. Some appeared to support chiropractic care which might well fall outside the Code and Statement [item 222].

It’s equally unsurprising that submissions arguing against a suspension included.

His references are excellent. They reveal a respected and trustworthy health practitioner.

The underlying story of the references is a reflection of Floreani’s entire defence. It’s a story of going through the motions, keeping within the lines. Indeed Simon Floreani doesn’t have to think like a health professional, but merely act like one. Ultimately that’s all that is required and it underscores the problem with chiropractic today and the Board’s inability to initiate serious change.

More so, as a chiropractor, Floreani need not be educated as an effective health professional nor maintain and update an evidence-based skill set. Despite his rhetoric, evident in the transcript, of him being a “critical thinker”, referring to “evidence” and “research”, vitalistic chiropractic deals in anything but. Floreani just won’t admit that his disdain for the sciences important to public health, is what keeps leading to disciplinary action. From item 184:

Dr Floreani was asked about his past disciplinary history. He agreed a caution was an important regulatory tool for practitioners who ‘misunderstood’ what they were doing consciously or unconsciously.

As mentioned, Floreani reinforced his anti-vaccination views by defending Well Adjusted Babies. He contended the content was “up for discussion” and thinks it is “research information”. This is what defines Floreani and his wife, Jennifer Barham-Floreani. These problems and others, did not escape the Tribunal as evidenced by item 220. It included:

While the content of that book is not strictly before us, Dr Floreani’s comments raised questions in our mind about whether he has absorbed the fact that the profession of chiropractic does not have adequate training or expertise in the science supporting vaccination. His reference to the ‘political climate’ being a factor in the discussion about the safety of vaccines was worrying.

The Board should be worried. Consider the disparity between assurances Floreani gives to regulators, and his wife’s response to a 2013 crackdown by the Board on anti-vaxxers.

Chiropractors will certainly be working towards making sure that the information that they convey to parents is the latest, up-to-date information that presents both sides of the vaccination debate. I think it would be very rare that there would be chiropractors giving only one side of the argument.

Which brings us back to the problem the Board faces. Whether it’s anti-vaccination beliefs, advertising claims void of evidence (if not plausibility) or the motions carried out on infants and in the name of “maintenance”, pseudoscience is endemic in vitalistic chiropractic. It’s an ideology that is enormously profitable and it exudes a trendy energy that continues to be disturbingly popular with an unsuspecting, cashed-up public. One gets the feeling the horse has bolted in reading item 234, in which the Tribunal comment on discourse arising from Floreani’s support of Vaxxed.

The underlying scepticism towards science continues to be potentially damaging and likely to bring the profession into disrepute.

The Tribunal was aware Floreani presented himself as a leader in his field [item 236]. It didn’t help him. Rather it contributed to the decision to enforce a suspension. It was seen as:

…an aggravating factor because it is inconsistent with the standards of the profession for such a person to promote the anti-vaccination cause and to provide unbalanced, biased and non-evidence-based information to the public.

This is as it should be. Any perceived success of Floreani should add to the suspension’s value in deterring others. Floreani had held a number of influential positions with the Chiropractors’ Association of Australia (CAA), now the Australian Chiropractors’ Association, including president from 2009-2012 [item 162]. Under his direction and authority, pseudoscience gained firm traction. His supporters were delighted when Floreani decided to run for the 2017 CAA presidential election. Then they were crushed when his short suspension (for the same reasons that led to this hearing), threatened his chances. At the time reasonable hank published Suspended chiropractor’s supporters liken themselves to Jews and AHPRA to Nazi Germany.

It’s an essential read and very much a case of in their own words. In pleading Floreani’s case they apply the very same offensive allusion to Nazism that has led in part to his suspension. For our purposes note the familiar theme we have come to hear almost daily during the COVID-19 pandemic. Often from chiropractors, one of whom was a referee for Floreani in this very hearing. Namely that when vaccination is attacked, those who defend the high standards of evidence-based health care and the science it relies upon are as the fascists of Nazi Germany. Those who wish to do what they want regardless of the harm it may cause others, are as the persecuted Jews whose very nature was unjustly targeted.

Which for the very last time brings us back to the problems faced by the Chiropractic Board of Australia. Problems that are ingrained in fundamentalist elements in chiropractic, in all countries in which they thrive. Australians have the right to ask how this came about. How can a movement that seemingly regards accepted evidence and regulatory standards as almost anathema, hold the position it does? How can chiropractors, be highly regarded by colleagues and rise to positions of influence, whilst spreading harmful disinformation?

Floreani’s referee Liz Anderson-Peacock was, in fact, one of three senior members of the council of the College of Chiropractors of Ontario to endorse anti-vaccination views. At the time she was vice-president of the CCO, report the National Post. There are similarities to Australia. The CCO is not unlike the CAA under Floreani’s influence. Jonathon Jarry is a science communicator at the Office for Science and Society at Canada’s McGill University. He noted that anti-vaccination views are “innate to a certain persistent strain of chiropractic”. With respect to the three members of the CCO, he had a winning comment:

If a professional regulator is allowed to be so wrong about a basic building block of public health, the public should demand change for its own protection. Swift action is needed to correct this dangerous misfire.

The answer to our questions then, is in appreciating that chiropractic here is often modelled on the already tarnished international movement that resurrected the unscientific beliefs of D.D. Palmer and now passes them off as health care. In fairness to Palmer, who got the idea from a deceased doctor’s ghost, he stated in 1911 that chiropractic should be regarded as a religion and he, its founder. The 126th anniversary of his first “adjustment” was recently observed on Facebook by Floreani’s referee, Gilles La Marche.

By necessity, Australia must at times internalise scientific trends from overseas. This is particularly true for evidence-based medicine. By definition then, we should firmly resist the influence of vitalistic chiropractic. The challenge for the Chiropractic Board of Australia and indeed for AHPRA is to do just that. A proactive regulatory process is needed. It should not be the responsibility of advocates for evidence-based public health to ensure reckless, dangerous actors are brought to account.

Simon Floreani has for years actively promoted disinformation and misinformation related to vaccination whilst attacking evidence-based medicine. He has given no indication that he has changed his views. Were he to have genuinely changed he would be a rarity in fundamentalist chiropractic. More so, he only need refrain from being overtly anti-vaccination in a professional sense. The problem with this, is that he never need be motivated to give sound advice on the topic.

A six month suspension is an undoubtedly insufficient sanction. Yet given the current scope of regulatory power it is an understandably appropriate response. The real problem is that Simon Floreani and other chiropractors like him should never have been practising in the first place.

That is the problem that must be managed.

* The Australian Vaccination-risks Network was at the time the Australian Vaccination-skeptics Network, and before that the Australian Vaccination Network. They are referred to in the ruling transcript as the Anti-Vaccination Network.


♠︎ ♠︎ ♠︎ ♠︎

There’s Something About VAERS

Since the inception of VAERS, anti-vaccination activists have misused reports as a cornerstone in their campaign to misinform and mislead. Vaccination against COVID-19 has led to that misuse exploding.

What is VAERS?

VAERS is the U.S. based Vaccine Adverse Event Reporting System managed by the Department of Health and Human Services (HHS) and co-managed by the Centers for Disease Control (CDC). It is an early warning system that collates reports of suspected adverse events following immunisation. A full explanation is here. Reports may be submitted by anyone who has received a vaccine authorised in the United States. Doctors, health workers, family members and associates can also submit reports. It is an open passive reporting system that allows reports from anyone who is aware of an adverse event they perceive as related to a vaccine.

It follows that the reports are just that; reports. Reports that contain no information about causality or indeed accuracy. This is not to say they are inaccurate. Rather that their true meaning, and indeed impact, can only be borne out in the context of further evaluation. Evaluation will assess any pattern of events, related health problems, any identifiable mechanism of causality and the time frame between vaccination and adverse event. Suspect vaccines would be suspended and emergency investigations employed to assess the scale and seriousness of adverse reaction(s). If the adverse event is confirmed to be more significant than in pre-licencing trials, the vaccine is removed from market.

Research and peer reviewed publication would follow, describing these findings. This information is of enormous benefit to the design, manufacture and trial of future vaccines. What stands out immediately is that determining adverse events due to vaccination requires significant input seperate from VAERS. The most important and irrefutable element about VAERS reports is that they do not represent cause and effect.

The VAERS site includes a Guide to Interpreting VAERS Data.

Under Evaluating VAERS Data:

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. […]

VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

Under VAERS Data Limitations:

Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors. […]

No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.

The above is a small selection from the guide. Yet it is enough to inform readers seeking definitive information on adverse events linked to vaccines, that it will not be found there. Exploiting the reports to provide an accurate picture of potential or existing problems takes resources. Resources that individuals don’t have. Consider the case of RotaShield. This rotavirus vaccine was taken off the U.S. market in 1999 because of an association between the vaccine and intussusception. The U.S. Advisory Committee on Immunisation Practices (ACIP) voted for its removal after an in depth review of available data. RotaShield was available for just months.

Paul Offit is well schooled in how VAERS is misused. He is also a firm supporter of civilian reporting because, as intended, unanticipated side effects can be caught this way. He has referred to VAERS as a “hypothesis-generating mechanism”, and observed about RotaShield:

There were a number of VAERS reports that patients within a week developed an intestinal blockage. A study was done and it was shown to be a causal association. VAERS was the tipoff. There’s value in it.

Medscape provide detail on the scale of the study:

The suspected association between RRV-TV and intussusception based on a review of VAERS data led CDC, in conjunction with state and local health departments, to implement a case-control study [in 19 U.S. states among 429 infants and 1,763 matched controls] and case-series analysis and a retrospective cohort study [among 463,277 children].

So yes. If it’s confirmation of adverse events due to vaccination one seeks, merely perusing VAERS isn’t enough. This doesn’t stop antivaxxers from abusing the VAERS database to create the illusion of wide scale “vaccine injury”. As we’ve seen time and again during the COVID-19 vaccine rollout, screenshots and memes reach a large audience. Discredited Australian Instagram influencer and anti-vaccine advocate, Taylor Winterstein, has misused VAERS data to attack “mainstream mentality”. These tactics have the added advantage of side-stepping the guide to interpreting what is limited data on VAERS. The same approach is used by right wing cable news outlets. There are numerous techniques used to avoid the reality that there is only a temporal, and not a causal, relationship between vaccine and adverse reaction. Presenting government data carries a certain authority. Stripping it of context ensures it is inaccurate.

OpenVAERS

Post hoc ergo propter hoc: After this therefore because of this. This fallacy is the fuel driving the VAERS misinformation empire. Without it, outright claims cannot stand. Nor could the inference and extrapolation that comes from accepting widespread vaccine injury and death. The Vaxxed II bus in Australia is a typical example. It began last year, collecting dubious testimonials on “the vaccine-killed and injured”. Last month it began targeting the COVID-19 vaccine. Removing context from VAERS data ensures post hoc fallacy. This is exactly what the OpenVAERS project does. Launched in September 2019, it was initially run from archivist.net as confirmed on the Facebook page of The Archivist. In January 2021 the domain switched to openvaers.com and focused on COVID-19 vaccination data. Unsurprisingly OpenVAERS is a favourite of antivaxxers. Until recently, the index page offered:

The OpenVAERS Project allows browsing and searching of the reports without the need to compose an advanced search (more advanced searches can be done at medalerts.org or vaers.hhs.gov).

That’s what we find on the archived index page as at 1 August 2021. The next capture is 23 August 2021. At some time between these captures, OpenVAERS included a link to its own copy of the VAERS disclaimer both on the index page and its impactful VAERS COVID Vaccine Data page. The change on the vaccine data page was minor. Compare the 23 July and 20 August pages below. Keep in mind this is what readers see when they land on the data page. To appreciate the importance of context I’ve included a screenshot of the government VAERS data page.

Prior to this, users of OpenVAERS would have to navigate to the About page and follow the link to the VAERS About page. The change came just prior to the publication by Logically, a misinformation tracking group, of an article on 12 August which revealed the name and face behind the site. Logically had posed questions and a request for comment, which may have prompted the design change. Lizabeth Pearl Willner (below) better known as Liz Willner believes her daughter was injured by vaccination and began posting anti-vaccine content on social media in April 2019. She insists the site exists to provide easy access to official data.

There were significantly more visits to OpenVAERS (1.23 million) than to VAERS (796.63k) between February and July this year. Logically discovered that 30 percent of referrals to OpenVAERS are from the right wing, fake news site, Gateway Pundit. 10 percent are from conspiracy theorist Vernon Coleman (old man in a chair). These sites promote COVID conspiracies, pseudoscience and anti-vaccination rhetoric. Willner’s now deleted Facebook account and recently deactivated Twitter handle @1pissedoffmom1, amplified the reach and impact of OpenVAERS.

Until April 2021 OpenVAERS included a dedicated and searchable vaccine excipients table. The OpenVAERS blog now returns a 404 page. Indeed those behind OpenVAERS seem intent on having their deleted content also removed from archive.org. When running, the blog provided a one stop antivax shop for COVID-19 misinformation for “warrior moms, dads and grandparents”.

Call For Action posts contained alarming inaccuracies about the COVID-19 pandemic and the safety of the COVID-19 vaccine. The posts linked to ready-made PDFs to be printed out and mailed to “friends, family, and elected officials”. The drill, as they called it, was “10 copies, 10 stamps, 10 envelopes, 10 chances to wake someone up”.

As recently as 2 August this year we find:

Unfortunately, coronavirus vaccines excel at producing iatrogenic injury. Since their rushed introduction in December, these shots have produced four times more fatalities than the terrorist attacks on 9/11.

A link to that particular post, along with the 9/11 reference was shared on The Defender. That’s the “news and views” site of Robert F. Kennedy Jr.’s Children’s Health Defense. The potential for harm by encouraging vaccine hesitancy in the midst of a pandemic is significant. Willner has ignored requests for comment from VICE News. The OpenVAERS blog also claims to be getting around “the criminal censorship of essential vaccine information on social media”.

Successful misuse of data this way relies upon the base rate fallacy. When vast sections of the population are involved, background mortality and morbidity become significant. Adverse events and deaths are reported in such numbers not because the vaccine is responsible, but because so many people are being vaccinated on any given day. Each person is given literature on how to report adverse reactions to VAERS. The V-Safe initiative includes regular text messages asking about any symptoms or changes to health. Attention given COVID-19 vaccination is unparalleled and this is reflected in data. Reports to VAERS (CSV VAERS Data accessed 3 September 2021) for all of 2020 totalled 63,544. To date, reports for 2021 ending 20 August, total 674,382. Not only are these reports unconfirmed but the safety of the COVID-19 vaccine is regularly affirmed.

Kolina Koltai is a Postdoctoral Fellow at the Center for an Informed Public based at the University of Washington. She describes OpenVAERS as “misinformation 101” and stresses that such decontextualisation is common to misinformation. Koltai uses such examples in classes that she teaches. In responses to questions posed by Logically, Liz Willner accused them of misrepresenting both VAERS and OpenVAERS. She cited data collected between 1990 – 2010 to argue, misleadingly, that “83% of reports are health care workers and Pharma”. Despite all evidence pointing to her, she insists OpenVAERS is a team effort. This is reflected on the site.

From the FAQ. Why is OpenVAERS necessary?

We built openVAERS because we found the HHS site difficult to navigate and get information from. We wanted a way to browse reports. Once we had that we decided to make it public.

How generous. Who is behind OpenVAERS?

OpenVAERS is a project developed by a small team of people with vaccine injuries or have children with vaccine injuries. We do not accept donations or solicit fees. There is zero monetization of this site. It is purely created in order to help others browse the VAERS records and to identify the reported signals that may otherwise get missed.

Here Willner misuses the term “signals”, specifically in how they relate to establishing risk. According to the CDC under How VAERS works:

Patterns of adverse events, or an unusually high number of adverse events reported after a particular vaccine, are called “signals.” If a signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.

The design of OpenVAERS allows immediate access to VAERS reports. These, in conjunction with tabulated figures, can be easily screenshot and spread via social media. Misleading commentary on these platforms aims to encourage vaccine hesitancy. One claim is that COVID-19 vaccines cause serious cardiac events and heart attack. In addressing this topic the indefatigable Orac picks apart flawed manipulation of data from Robert F. Kennedy Jr. and Children’s Health Defense. Back in May the energetic David Gorski addressed the “vaccine holocaust” based on VAERS data that Mike Adams bravely announced. Examples abound. The one constant, and undoubtedly something to be factored into public education, is that misuse of unverified reports is a key driver of vaccine hesitancy.

Despite long standing problems, VAERS works. RotaShield is a case in point. Twenty years of research preceded its approval by the FDA. Four months after ACIP recommended a three dose schedule for all infants it was suspended to allow for a CDC investigation. There had been twelve reports to VAERS of intussusception. Dorit Reiss, a law professor at UC Hastings and pro-vaccination activist, shares Paul Offit’s view that submitting reports to VAERS should be easy for members of the public. Reiss has suggested withholding reports that are “clearly not credible”.

One imagines this would include suicides, drownings, car accidents, homicides, and so on. To appreciate the less credible, or in this case incredible, consider the case of James Laidler M.D. He submitted a report to the effect that the influenza vaccine turned him into The Incredible Hulk. It was accepted. To reinforce this flaw Kevin Leitch of Left Brain Right Brain, submitted a report to VAERS that his daughter had turned into Wonder Woman following vaccination. This too was accepted. The ease of submitting dubious reports has been raised with antivaxxers. The unanimous reply is that submitting a false report to VAERS is a felony. This was also argued by Liz Willner when defending her conduct to Logically. The Hulk and Wonder Woman however, remain felony free.

It is clear though, that VAERS as it presently exists is of benefit to U.S. public health. Given that so much of the anti-vaccination response to the COVID-19 vaccine rollout was anticipated it is unfortunate that the abuse of VAERS was not proactively met. The outlay of resources to say, educate, or at least inform the public would not be prohibitive. The probable cost of managing the harm that exploitation of the system has, and will continue to cause is significant. Of course that’s an easy observation to make in hindsight. Nonetheless, any measures taken now to manage misinformation adversely effecting vaccine uptake would likely be justified.

VAERS Underreporting

The misuse of VAERS data is rarely complete without also misrepresenting the fact that adverse events following vaccination go largely unreported. In other words VAERS data represents underreporting. Given that the majority of events are minor, such as injection site soreness and redness or involve headaches, fever, aches, nausea, itching and so on, this is to be expected. For the anti-vaccination lobby the aim has always been to create the illusion of large scale death and serious injury, then compound this by claiming it represents only a small fraction of actual cases. Judy Wilyman favoured this tactic to smear successful HPV immunisation campaigns and indeed all vaccines. Liz Willner doesn’t disappoint.

VAERS is the Vaccine Adverse Event Reporting System put in place in 1990. It is a voluntary reporting system that has been estimated to account for only 1% (see the Lazarus Report) of vaccine injuries. OpenVAERS is built from the HHS data available for download at vaers.hhs.gov.

From the OpenVAERS blog post of 2 August 2021:

The 518,769 injury reports are just the tip of the iceberg as a government-funded study concluded that “fewer than 1% of vaccine adverse events are reported.”

This is more decontextualisation. It is unlikely visitors will read the report or indeed search for definitive reviews of the one percent finding. Also, as data are from a government authority, and underreporting is represented on government sites, an appeal to authority is in constant play. Antivaxxers have thus quite confidently used this two pronged approach for over a decade. Adapting to the rollout of the COVID-19 vaccine while obfuscating increased reporting of symptoms and the role of V-Link, has proven seamless for established lobbyists.

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

Reuters report the case of an antivaxxer reiterating falsely that only one percent of deaths and injuries following the COVID-19 vaccine are reported. The article includes this comment from a CDC spokesperson:

Mild events, like a rash, tend to be reported less frequently than severe events (like a seizure). We have data to show that serious adverse events that occur after vaccination are more likely to be reported than non-serious adverse events. Events such as a sore arm at the injection site might not get reported since they are expected and therefore people don’t feel the need to report them.

A December 1995 study of passive surveillance sensitivity in The American Journal of Public Health reported 72% for poliomyelitis after the oral polio vaccine and less than 1% for rash and thrombocytopenia after MMR. A 2020 study of VAERS sensitivity published in Vaccine noted in Background, a similar rate of 68% capture for poliomyelitis after oral polio vaccine and 47% capture of intussusception cases after rotavirus vaccine. The target objective of anaphylaxis and GBS following various vaccines revealed a range from 12% to 76%. As early as 2003 a study found that serious events are rare.

What antivaxxers won’t tell you

The evident paucity inherent in the misuse of VAERS data becomes apparent when examining another appeal to authority employed by antivaxxers. Namely the amount of money awarded to “victims of vaccine injury” via the Vaccine Injury Compensation Program (VICP). Total compensation paid out over the life of the VICP, since 1988, is in the area of $4.6 billion US. Members of the anti-vaccine lobby often cite various approximations of this figure to underscore their claim that vaccine damage occurs on a huge scale. In fact a simple analysis of VICP figures reveals the opposite to be true.

The report states that for every 1 million vaccine doses, “approximately 1 individual was compensated”. This is a familiar figure. The table below contains the monthly VICP statistics update report for 1 January 2024. It may be found on page three of the data and adjudication statistics report from Health Resources and Services Administration. It is headed Adjudication Categories, by Alleged Vaccine for Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filings. NB: Influenza doses = 45% of total doses since 2006.

From 1 January 2006 to 1 January 2024 the number of vaccine doses distributed, as sourced from the CDC, totals 5,050,074,788. The total number of compensable cases is 8,182. Or 0.00016% of distributed doses. The Influenza vaccine accounts for 73.9% of compensable doses. Total settlements, including dismissed cases and non-compensable cases to date, have reached 11,421. Or 0.00023% of distributed doses. This represents a striking absence of vaccine injury. Unsurprisingly you will not hear these figures from the anti-vaccination lobby.

TABLE: Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filing [updated monthly]

Since January 1988, 24,538 petitions have been filed [page 5]. 8,439 or 34% of petitions were compensated. More so, as the HRSA report states, “Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury”.

And:

Approximately 60 percent of all compensation awarded by the VICP comes as a result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.

Before moving on it’s worth reflecting on the fact that both VAERS and the VICP exist thanks to the efforts of established anti-vaccine campaigners such as Barbara Loe Fisher. Their campaigning led to the creation of the 1986 National Childhood Vaccine Injury Act, which is itself the subject of Andrew Wakefield’s most recent film claiming widespread vaccine injury. As we can plainly see not only are compensated cases exceedingly rare, but only 40% of those demonstrate a causal link to any vaccine. One expects it is not rash to expect that in time we will see similar figures pertaining to COVID-19 vaccines.

Antivax Winning Formula

Misrepresenting VAERS data is a simple winning formula for antivaxxers. It follows that it can be applied to any adverse event reporting system, particularly those employing passive surveillance. The COVID-19 vaccine rollout is unprecedented and subject to significant scrutiny. Governments support the reporting of adverse events and deaths post COVID-19 vaccination. The winning formula thus ensures the anti-vaccination lobby has a significant advantage in spreading its message. Data from the U.K., the E.U. and Australia have also been misused this way. The exploitation of coincidental deaths following COVID-19 vaccination was met quickly and comprehensively by Australia’s Therapeutic Goods Administration. Not surprisingly this had no effect on those opposed to vaccination against COVID-19.

Analysis of application of the winning formula to other government reporting systems is beyond the scope of this post. However, Australians have made good use of the tactic both before and during the COVID-19 pandemic. Underreporting of adverse events was mentioned in a May 2019 press release from the Informed Medical Options Party. They promise a “more accurate” system if elected. More recently, misused data from the U.K. Yellow Card voluntary reporting system was retweeted by Australian senator Malcom Roberts. United Australia Party leader, Craig Kelly, randomly texts Australians with a link to screenshots of reports to the TGA Database of Adverse Event Notifications. In April 2021 Judy Wilyman cited conspiracy theory website accounts of unverified reports to smear COVID-19 vaccine. A flyer packed with false and unverified deaths and injuries from four different reporting systems was tweeted by Meryl Dorey in mid June 2021. Watch this space.

Conclusion

The U.S. Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system open to the public that has, since its inception, been exploited by the anti-vaccination lobby. The absence of any causal relationship between vaccine and report is ignored by antivaxxers. The introduction of the COVID-19 vaccine has accompanied unprecedented reporting due to increased vaccination with active encouragement of recipients to use the VAERS system. The rise in reports was to be expected. This clinical reality has been obfuscated by players in the anti-vaccination community who have skilfully used social media to present background mortality and morbidity as causally linked to COVID-19 vaccination.

The website OpenVAERS, dedicated to misrepresenting VAERS data has focused exclusively on COVID-19 vaccination since January 2021. An investigation by Logically found Lizabeth Pearl Willner from California is the force behind the site. A frenetic antivaxxer, Liz Willner attempted to dismiss her activity as provision of easy access to data. Since the investigation she has been actively removing her anti-vaccination footprint on social media whilst keeping the site active.

Payouts from the Vaccine Injury Compensation Program to date total $4.6 billion. Often cited by antivaxxers as further evidence of widespread vaccine related harm, VICP settlements from 2006 – 2019 equate to 0.00015% of vaccine doses given in that period. The Influenza vaccine accounts for 71.6% of this total.

Misrepresenting VAERS data to convince others that vaccines cause significant harm has proven to be both durable and successful. Combined with the misleading claim that only one percent of all events are reported, the result has almost certainly been an as yet unknown increase in vaccine hesitancy. Familiarising the public with the manner in which such data are misused may alleviate some amount of vaccine hesitancy.

COVID-19 vaccines are safe and effective.


References and reading

Vaccine Adverse Event Reporting System – HHS

Guide to interpreting VAERS data – HHS

CDC: VAERS

Surveillance for Adverse Events Following Immunization Using VAERS – CDC

Selected Adverse Events Reported After COVID-19 Vaccination – CDC

Anti-vaccine activists use a government database to scare the publicScience

Anti-Vaxxers Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous – VICE

California Woman Behind Antivax Site Outperforming Government DatabaseLogically

The Woman Who Secretly Runs One of the World’s Biggest Anti-Vax Websites From Her House – VICE

Hugely Popular Antivax Site Is Just Some Lady In Piedmont

Unverified reports of vaccine side effects in VAERS aren’t the smoking guns portrayed by right-wing media outlets – they can offer insight into vaccine hesitancy – The Conversation

Reports of adverse effects in US database aren’t confirmed to be linked to vaccination – Fact check

Large real-world study: Pfizer’s COVID vaccine is safe

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) – PDF

Underreporting and Post-Vaccine Deaths in VAERS Explained

The reporting sensitivity of VAERS for anaphylaxis and for Guillain-Barré syndrome

VICP Monthly Statistics Report October 2021

VICP Monthly Statistics Report November 2021

Last update: 27 January 2024

♠︎ ♠︎ ♠︎ ♠︎