Recently there has been some press coverage that potential running mates for Robert F. Kennedy Jr., are themselves well versed in conspiracy theories.
Kennedy, the driving force behind anti-vaccine pressure group Children’s Health Defense, which includes Children’s Health Defense Australia (recently abandoned website), is running as an independent for President of the USA. One possible running mate is Jesse Ventura who was mentioned here when the antics of Rima Laibow were reviewed. The other is Aaron Rodgers who has entertained a number of conspiracy theories including denial of the Sandy Hook shootings. Both are anti-vaxxers.
Kennedy has lobbied for years promoting the debunked link between MMR vaccines and autism. In the early days of the COVID pandemic he emerged as a vocal critic of COVID-19 vaccines. Which for a presidential contender, is understandably proving to be a problem. As measles cases rise across the US it isn’t surprising that Kennedy is not attacking vaccines on the campaign trail. In April last year Kennedy announced he would take leave of his roles as Chairman and Chief Legal Counsel of CHD, although the US site still lists him as both.
Exactly why the CHD Australian chapter URL is parked, just seven months after launching is unclear, although the Instagram page remains. What can’t be denied is Kennedy’s long history of spreading vaccine disinformation. In the early days of his campaign Kennedy talked about plans to tell NIH scientists it is time “to give infectious disease a break for about eight years”. However as his presidential campaign continues he is, according to NBC in the below clip, keeping his usual anti-vaccine message “relatively quiet”.
RFK Jr. relatively quiet on antivax message despite past ties
Critical overdose events at three Australian dance parties in January this year, have led to more calls for Pill Testing (PT) to be introduced as part of our nation’s effective Harm Minimisation drug policy. Harm Minimisation consists of three prongs: Demand Reduction, Supply Reduction and Harm Reduction.
Strong evidence
Pill testing is an evidence-based, harm reduction initiative backed in peer reviewed literature. It reduces drug harms and protects the health of those who access the service. Whilst Australian drug markets are uniquely sourced and specifically affect Australians, Harm Reduction Australia cites Harm Reduction International, in answering the question, What is harm reduction?
Harm reduction refers to policies, programmes and practices that aim to minimise negative health, social and legal impacts associated with drug use, drug policies and drug laws. Harm reduction is grounded in justice and human rights. It focuses on positive change and on working with people without judgement, coercion, discrimination, or requiring that they stop using drugs as a precondition of support.
PT has been demonstrated via live trials at Canberra’s Groovin The Moo festival in 2018 and 2019, to be effective in positively changing behaviour related to drug use. The trials were conducted by Pill Testing Australia, and resulting evidence greatly contributed to the fixed-site testing facility CanTEST, an ongoing trial in Canberra, introduced in July 2022. Indicating the controversy of PT, days before a third dance festival trial was scheduled to begin in 2022, Pill Testing Australia had public liability insurance withdrawn, without explanation.
A 2019 election study found two thirds of Australians support PT at music festivals. Examining deaths, PT initiatives, the success of harm reduction and drug user responses, Andrew Groves wrote in The Harm Reduction Journal in 2018:
Using a theoretical frame of pragmatism and drawing from national and international research evidence, this paper recommends the integration of pill testing into Australia’s harm minimisation strategy.
Australia’s Alcohol and Drug Foundation have published an excellent summary of the evidence supporting PT, and provide data on its successful international uptake. They also point out that public health experts have demonstrated support for PT. These include:
In February 2023, directly citing the success in Canberra, the QLD Palaszczuk government announced plans to develop Drug Checking at fixed and mobile sites. This very shortly followed the state’s plans to reduce penalties for illicit drug possession, including heroin, ice and cocaine. More so, use of the term “drug-checking” is more realistic, inclusive and in line with international practice, as summed up in this opening paragraph from the QLD Network of Alcohol and other Drug Agencies (QNADA):
Drug checking – also sometimes referred to as ‘pill testing’ – involves members of the public voluntarily providing samples of suspected illicit substances they are intending to consume (e.g. tablets, capsules, powders, tabs/blotter paper etc) for chemical analysis.
Test results are provided back to the individual by health professionals as part of a personalised health and harm reduction intervention. The purpose of the intervention is to increase the person’s awareness of the risks associated with the substance with the aim of effecting behaviour changes that result in fewer harms or incidences of drug-related death.
In September last year the QLD government sought private providers to offer plans for two fixed drug-checking sites and mobile services. Of course, great strides like this rarely escape unhelpful politicisation. It was impossible to miss that when announced, the decision was called “soft on drugs” by QLD opposition health spokeswoman, and registered nurse, Ros Bates. It’s been a long time since I’ve heard that phrase used seriously.
Victoria
It is Victoria, to where we must turn our attention to partly examine the recent overdose events. RACGP reported eight people, most in their 20s were intubated and placed in induced comas after MDMA overdose at the Hardmission dance party in early January. Jollyon Attwooll reported:
Chair of RACGP Specific Interests Addiction Medicine Dr Hester Wilson described the introduction of festival pill testing as ‘a no-brainer’. ‘[Pill testing] actually does change people’s behaviour, and therefore it makes it safer,’ she told newsGP. Dr Wilson said that pill testing is ‘not a silver bullet’ but should be used as part of a range of measures to address drug use.
Following the Hardmission OD events, two women were taken to hospital on January 12 after suspected drug use at Juicy Fest. Current Victorian Premier Jacinta Allan initially stated she had no plans to introduce PT. Not long after, Allan advised that she would seek more information from the health department. The Premier sensibly observed:
I think it’s important to examine the evidence and advice and consider that in the policy setting that we have across all of our alcohol and drug policy measures, which is taking a harm minimisation approach, looking at the safety of people going to events.
The ACT
The evaluation document of the 2019 ACT Pill Testing trial is a lengthy read, with confirmation of Dr. Hester Wilson’s words coming through in data and discussion. I won’t copy/paste quotes from patrons who attended the PT facility, but I do recommend skimming through to appreciate that PT, like other harm reduction initiatives, changes drug users behaviour for the better. I did appreciate the graphs on self-reported knowledge of harm reduction before and after having a drug tested. Likewise, when it came to choice of information source, positive changes are evident.
Detailed explanation of the slides below can be found at section/s 6.1 (fig. 1), 6.4.1. (fig. 3) and 6.4.5. (fig.4).
Sydney
At the end of January a challenging scenario unfolded at Sydney’s HTID festival. Having taken what he thought was MDMA, an attendee fell unwell. Ultimately he responded to naloxone, a drug that reverses the effect of opioids. He had taken a tablet cut with nitazene, which is a synthetic opioid reported as “stronger than” fentanyl or heroin. Health workers and members of drug safety volunteers DanceWize, worked to advise the crowd. No doubt they saved lives. It turned out others from around Sydney had been hospitalised that weekend. One pill analysed, contained nitazene and no MDMA. Guardian reported:
Chris Gough, chief executive of the nation’s only pill testing venue in Canberra, said the detection of nitazenes in pills sold as MDMA showed the need for similar services in other states.
“In this case, where a nitazene has been sold as MDMA and therefore people are completely unprepared and potentially opioid naive, the risk of overdose is extreme,” said Gough, who is the executive director of the Canberra Alliance for Harm Minimisation and Advocacy.
“As we have now seen nitazenes in several jurisdictions in Australia it is time to act swiftly to provide drug-checking services throughout Australia so that we can respond to these drug trends as they emerge and thereby save lives and inform the community.”
Canberra
Saving lives is far more about probability than possibility. Indeed that’s been the case with MDMA overdose, MDMA pills cut with N-ethylpentalone or other adulterants. Early last year the Canberra walk-in site CanTEST discovered a pill cut with metonitazene; a synthetic opioid with a potency up to 200 times that of morphine. The owner chose to dispose of the drug on site. In January this year, ANU chemists made an Australia-first discovery of three new recreational drugs. All came from preparations sold as something else. CanTEST staff were able to discern the drugs were not what they were supposed to be, but tests were inconclusive. They were however, able to warn the community. One substance thought to be a derivative of Ritalin was in fact a new variant of cathinone, commonly known as “bath-salts”.
ACT Health have also developed a comprehensive document for festival planners. The Festivals Pill Testing Policy, examines PT options as a service available for festival attendees and how it relates to harm minimisation. Advice on general and specific health and safety measures, the importance of peer support, relaxation areas, emergency services and how PT works with providers and the event itself, is only part of the clear information presented.
Coronial support
A number of fatalities, and the fact that PT promotes positive decision making led to multiple calls to introduce the practice as a policy initiative. Over the last six years, four state coroners have spoken out. A 2020 inquest into five deaths from July 2016 to January 2017, led Victorian coroner Pares Spanos to urge the Victorian government to “urgently” introduce drug checking and a system to warn the community about dangerous substances sold as MDMA. The males aged from 17 to 32 died in a variety of tragic ways after taking what they believed was a modest dose of MDMA. Autopsy revealed the substances 25C-NBOMe and 4-Fluoroamphetamine in their systems. The cluster was discovered after 20 hospitalisations stemming from the Chapel Street nightclub district in January 2017. Victoria Police knew of the dangerous drug’s presence and later defended their decision to not warn the community.
In September last year, Victorian coroner John Cain also called on the government to introduce PT after the death of a man from an MDMA overdose in March 2022. The man had been observed taking a Blue Punisher, a pill with dangerously high levels of MDMA. He was admitted to the Royal Melbourne with brain swelling and multi-organ failure and died four days later. In his findings Cain wrote:
It is impossible to know whether, had a drug checking service existed, [the man] would have submitted a sample of an MDMA pill for testing before taking it at Karnival […] Notwithstanding this, a drug-checking service would have at least created the opportunity for him to do so, and for him to receive tailored harm reduction information from the drug-checking facility.
It is likewise impossible to know whether, had [the man] been provided information of this type, he would have changed his drug consumption behaviour; but likewise, in the absence of a drug checking service, this was not a possible outcome.
Politics
NSW and Victoria have established histories of resisting PT. After the death of a 26 year old at a Sydney music festival in February 2023, Dominic Perrottet mused about his government’s inquiry into methamphetamine and, rejecting any notion of PT offered a most unhelpful contribution:
But my clear message to people right across NSW [is] stay safe, and don’t take drugs and you will be safe.
Associate Professor David Caldicott, one of the driving minds behind CanTEST, suggested Perrottet had engaged in “magical thinking”. In Victoria we have the legacy of Dan Andrews who, citing the demonstrably false [HRJ] claim that PT encouraged pill taking (a belief favoured by Craig Kelly), insisted that under his leadership PT would never be introduced. The state opposition has been steadily opposed to harm reduction measures for conservative political reasons. Ignoring evidence, consecutive opposition leaders have opposed Safe Injecting Facilities and PT alike. I do acknowledge however, that the Victorian opposition has lobbied the state government for more effective emergency drug alert systems.
Recent research
A recent paper Drug-related deaths at Australian music festivals, was published last month in the International Journal of Drug Policy. Examination of the National Coronial Information System (NCIS) yielded the following results about fatalities at music festivals between 2000 and 2019:
There were 64 deaths, of which most involved males (73.4%) aged in their mid-20s (range 15-50 years). Drug toxicity was the most common primary cause of death (46.9%) followed by external injuries (37.5%). The drug most commonly detected or reported as being used was MDMA (65.6%), followed by alcohol (46.9%) and cannabis (17.2%), with most cases reporting the use of two or more drugs (including alcohol) and 36% reporting a history of drug misuse in the coroner’s findings. Most deaths were unintentional, with less than a fifth of cases (17.2%) involving intentional self-harm. Clinical intervention was involved in 64.1% of cases and most festivals occurred in inner city locations (59.4%).
There are complex factors identified in the paper, such as inner city events and multi-day events being more likely to be the site of a fatality. This may reflect policing strategies and the need for harm reduction strategies, respectively. Alcohol is known to be a compounding factor and its use is clearly identified as the second most prevalent substance (see bar graph below). Males are more likely to drink and use MDMA and this is reflected in them making up just under three quarters of deaths. Of 2000 festival goers surveyed, 52% were male. Poor decision making associated with alcohol intake is always a potential factor with illicit drug use.
Total number of drug-related deaths, deaths primarily attributed to MDMA, and deaths primarily attributed to alcohol, at music festivals in Australia by year ranges (n=64)
Harm reduction flexibility
What I took away from this paper was the recommendation that a range of harm reduction measures would each have something to offer in solving this persistent, multifactorial problem. More so, understanding data yielded by such research is vital to establishing the correct harm reduction approach for the Australian population in these instances. In conclusion, the authors write:
Harm reduction strategies such as roving first aid volunteers, mobile medical care, spaces to rest, hydration stations, and drug checking services, may best address some of the risks associated with illicit drug use at festivals, in addition to increased consumer education and awareness. It is important to understand the factors involved in these incidents in order to inform policies around harm reduction and law enforcement at music festivals in future to prevent further deaths.
Just as is the case with injecting facilities, substance checking is a successful, global health policy dynamic. Like all aspects of harm reduction the evidence supporting it is strong, persisting through variations specific to where it is a reality. In Canada, Toronto ran a comprehensive trial from 2019 to 2023. Switzerland has had drug checking available since the 1990’s. Now in a number of cities, the past decade saw a 250% increase in samples tested there. The UK has drug checking services, as does New Zealand.
Despite certain dynamics in NSW and Victoria leaving state governments out of touch with most Australians, there are cabinet ministers and cross-bench teams respectively, raising awareness and pushing for change in each state. When we look at arguments for and against PT, it appears arguments against, lack realistic substance. Indeed these documents recognise the importance of harm minimisation and its place in the National Drug Strategy. The most comprehensive argument “against” is criticism of the limitations of on-site drug checking, compared to laboratory testing. This is well understood and has been directly addressed by Dr. Monica Barratt. Of course the inevitable case that flexible harm reduction measures encourage or create the illusion of safety around illicit drugs is always mentioned. The evidence simply does not support this.
Drug Free Australia
This brings us to the anti-drug lobby. Certain groups contend that law enforcement and zero tolerance are superior in managing drug related harms. Stridently anti Harm Minimisation, they promote the ideology of a drug free world, consistently undermining evidence. In fact my own interest in the anti-vaccination lobby, began in 2009 and I was struck by similarities between their tactics, and those of the more lethal anti-drug lobby, I was long familiar with.
One group, Drug Free Australia (DFA), operate similarly to The Australian Vaccination-risks Network (AVN). DFA aggressively lobby government and an unsuspecting public, frequently using alarming irrelevant information. They attack the media, use meaningless or decontextualised data to dispute published evidence or argue that acknowledging a need for more research, reveals lack of any research. DFA dismiss harm reduction techniques by highlighting the ongoing presence of harm (eg; MDMA has caused deaths, thus no rationale for PT exists) or blame harm reduction for drug user risk-taking, and the familiar contention that PT “green lights” the taking of MDMA.
Such contentions stem from ignoring that high risk behaviour via illicit drug use continues all day, every day in Australia. Harm reduction aims to reduce the harms associated with this behaviour. It provides education, promotes safe choices, saves our health-system money, and yes, saves lives. One way DFA contend PT actually kills, is by misrepresenting the PT card system. A drug found to contain what the owner expected is “white-carded”; as is say, an MDMA pill free of any pollutant. Yet, MDMA causes most overdoses say DFA, so a white-card result must be potentially lethal. Well, no. The drug is what the person expected. Not double or five times the amount. So the patron may take the drug they bought and, remembering the slide show above, will henceforth access reputable information on harm reduction.
Those slides are from the ACT Pill Testing Trial 2019. DFA attack those findings in a deceptive piece, arguing the opposite to accepted findings. On page 7, they selectively quote from evaluators who discuss that someone who discovers that the drug is what they thought, “…are likely to take as much or more” (p.33). And that “…concordance between expectation and identification is associated with stable or increased intention to take a substance” (p.34). DFA use this to extrapolate to the conclusion that PT will lead to more use and thus, more death. This requires logical fallacies: Decontextualisation and cherry picking of data. Reading the full sentences and paragraphs in which those terms appear leaves the reader with a positive, not negative view of the evaluation. See pp. 33-34, and consider Table 5 from p. 32, below:
When read in context we see that patrons intent to use drugs did not dramatically change, but their intent to engage in harm reduction behaviour notably increased. Eg, also on p.33 (bold mine); Many interviewees reported that the quantity of drugs that they intended to use did not change after testing, as the drug was identified to be what they expected. And, Many interview patrons indicated that their intention to use did not change, but their intention to engage in harm reduction behaviours did increase. Also, this and other evaluations have found non-concordance between patrons’ expectation of what a substance is and what a substance is identified to be, commonly leads to reduced intention to take that substance.
So, the comment pulled from p. 33 by DFA, omits crucial clarification from the evaluation. Some was printed on the same page, just two paragraphs above. For example:
Interview data suggests that this group were looking for confirmation of the contents of the presented drug, and information about how to reduce potential harms. Many interview patrons indicated that their intention to use did not change, but their intention to engage in harm reduction behaviours increased.
Prior research also indicates concordance is associated with an increased likelihood of taking the drug, and non-concordance with a decreased likelihood (Valente: 2019, and Measham: 2018). More so, the evaluators stress that modification of drug consumption can’t be measured alone. Contextual factors, such as type of festival influencing available drugs, need to be considered during interpretation of results and future study design.
Finally, the insistence by DFA that MDMA, not impurities, lead to most fatal overdoses is fashioned only to discredit PT. Still, five deaths in the six months leading up to January 2017 and investigated by Coroner Pares Spanos involved 25C-NBOMe and 4-Fluoroamphetamine. Recent discovery of potent opioids nitazene and metonitazene raise further concern. N-ethylpentalone is regularly found in so-called MDMA pills. But why get hung up on MDMA? Drug checking can check any drugs and CanTEST discovered three unknown substances, later confirmed at ANU. This is how a new type of cathinone (bath salt) was found. Supposed ketamine was actually a new type of benzylpiperazine (BZP) stimulant. The third find was propylphenidine.
Conclusion
Pill testing or drug checking is a harm reduction measure supported by consistent evidence in peer reviewed literature. Globally, where introduced, it has demonstrated success and improved understanding of behaviour. It is supported by most Australians, where valuable data has been gathered from on-site testing at music festivals, and the fixed site CanTEST, in Canberra.
This has expanded the nation’s understanding of drug user insight into, and uptake of harm reduction dynamics. QLD is the most recent state to confirm permanent drug testing. Arguments against the initiative are morally subjective and/or deceptive, leading to their swift deconstruction.
Drug checking saves lives and is supported by public health experts across Australia. As a dynamic, expanding, harm reduction initiative, it should be introduced nation-wide into Australia’s harm minimisation strategy.
♠︎ ♠︎ ♠︎ ♠︎
Originally published as Pill Testing: The harm reduction initiative supported by strong evidence
On Monday 22 January 2024 the unique home for all things COVID conspiracy, Café Locked Out, hosted a video titled The Launch of OpenDAEN, A free database of Adverse Events. Cutting to the chase, OpenDEAN, promoted and launched by Sharon Cousins, purported to be an easy and honest means of access to the Therapeutic Goods Administration, Database of Adverse Event Notification.
Like its namesake previously debunked here, OpenVAERS, the Australian analogue of misleading information, OpenDAEN, presents decontextualised data in a manner that seeks to create the illusion COVID-19 vaccines are inherently unsafe. That “vaccine injuries” are rampant. Again like OpenVAERS it presents as conclusive fact, reports of negative health experiences observed in, or claimed by, an individual after that individual received a COVID-19 vaccine.
Like the TGA, OpenDAEN uses the Medical Dictionary for Regulatory Activities (MedDRA), to classify adverse reactions. It provides filtering with the European Medicines Agency, Important Medical Events list and Pfizer’s analysis of post authorisation adverse events. An additional adverse reaction of “serious” has been added to OpenDAEN. Sharon Cousins is an erstwhile insurance executive, now presenting as an “independent researcher” with a penchant for criticising COVID-19 vaccines. Sharon could not share her screen and was directing suspended NSW anaesthetist Paul Oosterhuis, the third member of this Zoom presentation, around the site.
The primary data interrogation categories on the index page of openDAEN are:
Case numbers by Year, Month and Sex
Cases by COVID-19 Vaccine Type
Case Numbers by Reaction term and Age
Case by Frequency of Batch Number
Table of case number, date, vaccine manufacturer, MedDRA reactions, Death, Serious cases and the FOI request number the batch number was confirmed by.
The index page offers the following:
Above: Slideshow: OpenDAEN website
OpenDAEN is called a “free database”. Don’t be fooled. The important elements here are reports and post vaccine, combined with the fact almost all adult Australians have had two COVID-19 vaccines, as have two thirds of 5-15 year olds. Random ill health events can and do frequently occur coincidentally with vaccination. It’s also important to realise that the TGA and health authorities encourage Australians to report these events, so that over time a greater understanding of these vaccines will emerge. OpenDAEN.info provides a description on each page footer:
OpenDAEN.Info is a non-commercial and not-for-profit website for the research, study and review of the TGA (Therapeutic Goods Administration) DAEN (Database of Adverse Event Notifications) system in respect of COVID-19 vaccines. The primary source of data on OpenDAEN is the TGA DAEN system and their published FOIs (Freedom of Information).
Decontextualisation
When taken out of context and denied TGA cautionary disclaimers, the reports become hearsay temporally related to something somebody did. Nothing more. This is decontextualisation. But apparently, we are to assume causation exists. OpenDAEN claims to be able to offer up to date, conclusive data related to adverse events caused by COVID-19 immunisation. These adverse reactions are the subject of reports sent to the TGA DAEN. So, the data themselves have a recognisable source. But can absolute conclusions be made with any real confidence? In reality it takes time for clinically relevant events, specific to any vaccination to be investigated, identified and acted upon. Unless already understood and published on the TGA COVID-19 Vaccine Safety Report (2 November 2023), the quality and quantity of adverse reaction is speculation. To make matters worse, the anti-vaccination lobby has invested an exceptional amount of time spreading disinformation via social media, and one of their primary targets has been the TGA DAEN.
The anti-vaccine lobby want every report to be an absolute reality. They want the figures, diligently and honestly provided to Australia by the TGA, to be accepted without examination as conclusive, in their misguided attempt to wipe out COVID-19 immunisation. We saw this claim time and again in the court affidavits of Peter Fam, Meryl Dorey, Julian Gillespie and Katie Ashby-Koppens; reports presented as if confirmation of death and injury in huge numbers. But correlation is not causation. If you haven’t clicked the link to DAEN by now, let’s see what the TGA, but not OpenDAEN, stress about the contents.
- DAEN SPLASH SCREEN DISCLAIMER –
Okay, so it confirms what I stressed above. But most crucially, you have to tick the teeny weeny little box next to I have read and understand the above, to access the TGA data. The disclaimer can’t be missed. Only willingly ignored. The importance of what this means and the restrictions the disclaimer places ipso facto, on OpenDAEN was studiously avoided during the video on 22 January. In fairness I will note that a small header on the TGA DAEN page was visible, but also ignored. It reads; Inclusion in DAEN – medicines does not mean that the adverse event has been confirmed or that it was caused by a medicine or vaccine. Clicking it – which the presenters also studiously avoided – reveals a little more about the DAEN content. Due to size restrictions of a screenshot, I’ll pop the text in a paragraph, and include some emphasis (mine):
The DAEN – medicines allows you to search adverse event reports for medicines including vaccines received by the TGA. The TGA uses adverse event reports to identify when a safety issue may be present. The DAEN – medicines does not contain all known safety information. An assessment of the safety of a medicine or vaccine cannot be made using the DAEN – medicines alone.
Talk to a health professional before starting, stopping, or changing your prescription medicines.
Anyone can report a suspected adverse event, including members of the public, health professionals and pharmaceutical companies. We encourage reporting even when it is not clear that a medicine or vaccine is the cause. Information from these reports is published in the DAEN – medicines and reflects the observations of the person who reported the event.
People who experienced an adverse event cannot be identified. Maintaining their privacy is of critical importance to the TGA.
The DAEN – medicines is a ‘living’ database that is frequently updated. Information may change if we receive more details on an existing report or if we identify duplicate reports and combine them. Updates may also occur as part of our data quality assurance activities.
In short, the TGA DAEN database is constantly growing, contains information from any member of the public, reflects the observations of that person, provides no information about the safety or lack thereof, of vaccines and does not confirm that an adverse event was caused by a vaccine. It cannot even confirm if the event has actually occurred. I might add, dear reader, given that the anti-vaccine lobby has gone out of its way to submit to the DAEN clearly impossible and even bogus reports, one must remain extra vigilant when assessing or querying these data.
Indeed, Sharon Cousins herself relayed an abuse of the TGA DAEN system at the 8:30 mark of the video. She had queried via FOI why a reported death of a 6 year old boy was no longer available on the DAEN. Sharon noted that within her FOI report FOI 4077 (“Batch numbers of COVID-19 vaccines of reported deaths”), it was revealed the initial report was submitted as a hoax. The relevant section of the report reads:
FOI 4077 also requested information about why case number 724925 no longer appears in the DAEN. This report was rejected following review of further information for the case. The information demonstrated that the report was submitted as a hoax and as such there is no identifiable patient. The report remains in the TGA’s internal database. However, it no longer is included in the DAEN as it has been rejected because it no longer met the minimum criteria for a valid adverse event report.
Sharon Cousins
Sharon also said the TGA reply included, “Normally we wouldn’t answer this”, after insinuating she has a positive relationship with them. However, that comment is clearly not there. One appreciates Sharon sharing this information, but cannot ignore that it took an FOI query of a fatality to uncover the truth. How many other adverse or serious adverse reactions were, or will be, “rejected following review of further information for the case”. Sharon was eager to reassure viewers that OpenDAEN was not misusing the TGA website, but rather making it “more user friendly”. It will be of benefit to TGA staff Sharon opined, and she had sent the site link “to the coroners”, and to State and Territory head pathologists.
Batch Numbers
Throughout, much is made of the section allowing search of batch numbers. We learn that when it comes to accessing batch numbers, the TGA, “Doesn’t have any search engines on it, is a little bit clunky and it times out”. The TGA freely provide data in CSV format on batch release assessment of COVID-19 vaccines. One of two release pathways is taken; either based on overseas certification or based on TGA laboratory assessment. The TGA explain this in detail. So, what could be wrong with smoother navigation of COVID-19 batch numbers as a function of vaccine type, reported adverse reaction and de-identified data? Usually nothing, unless one ignores TGA advice and extrapolates to conclusion, based on other available data.
At the 50:00 minute mark Sharon directs navigation through the number of cases per batch number, highlighting batch number FP1430 – COMIRNATY, (Pfizer), in section 4. OpenDAEN has accessed the batch numbers via FOI, and that’s fine. OpenDAEN reveals inordinately more adverse reactions for male and female associated with this batch number, compared to those next to it. Sharon instructed more data access and directed navigation to the batch number table. She continued:
Look at the dates! Look at all the dates! Within 24 hours of the Pfizer being released on the younger children, the five to elevens… it was all advertised, tenth of January [2022], five to eleven year olds… within 24 hours we have reported cases. Now that for me is causal proximity.
Sharon continued on, directing suspended doctor Oosterhuis to isolate reported – not confirmed – fatalities using that batch number and age group. They isolate two boys. Zeroing in on the symptoms of one boy, Sharon reads, abdominal pain, then dismisses adverse event following immunisation as “a very bland one”, then cardiac arrest. She has Paul Oosterhuis explain eosinophilia and eosinophilia myocarditis. He assumes he is explaining the findings of both of “these boys”. In fact the data reveal clearly it is only one boy. A five year old.
The ten year old “fatality” has only Adverse Event Following Immunisation listed. The “very bland one”, dear reader. Then Sharon warns us “It’s a little bit distressing now, okay. The two boys both had the same batch number”. She gets Oosterhuis to zoom in and suggests, “So, screen print that people if you don’t believe us”. After zooming in on the case numbers Sharon has Oosterhuis zoom in on the batch numbers again, as if she hadn’t made that point enough times already.
Now, I am not a lawyer but I doubt the strength of Sharon’s “causal proximity” claim. There is another factor Sharon told us herself, that must be considered. As she points out, the roll out for Pfizer for 5-11 year olds was 10 January 2022. Thus, the first factor I would investigate would be the sheer number of children being vaccinated, at the time of release. Over 11 weeks, 76.6% of those 2.3 million children were vaccinated. 1,761,800 children had one dose. 1,552,500 (67.5%) had two doses. The vaccine for 5-11 year olds is one third the dose approved for children aged 12 years and over. Cold chain transport and storage is vital to the success of mass mRNA vaccination programmes.
Using OpenDAEN to interrogate vaccine batch numbers of adverse reports about 5-11 year olds, over the first two months of the rollout, we see virtually one result: FP1430. Yet what is more likely? Batch FP1430 is responsible for all adverse reaction reports? Or most 5-11 year olds vaccinated in the initial days, were dosed from batch FP1430? By the end of February other batch numbers begin to appear and gradually attract more reports. By late March, FP1430 is just another batch number. More so, there are over 500 unknown batch numbers for that age group. However, if you present your disinformation just right, some might believe in the deliberate harming of children:
– Facebook comment –
What do the TGA say?
There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination. More detail on these deaths is available in the safety report published on 15 December 2022… If we identify a new death likely to be related to vaccination, we will publish this information promptly, as we have for all other cases since the start of the vaccine roll-out. [Source – 2 November 2023]
Of the 14 deaths the TGA confirm are linked to vaccination, none are in the 5-11 year age group. Yet Sharon is convinced of her claim, has already convinced others and will convince more, simply because of bias. Her defence, I suspect, will be that she used FOI legislation to access reports on batch numbers and the TGA lacks the smooth batch number access and navigation of OpenDAEN. Yet Sharon made up her mind before she even started looking. In fact, Inclusion in the DAEN does not mean the event has been confirmed or determined as related to a vaccine, is utterly ignored when using OpenDAEN.
The reactions reported in January, are based on MedDRA. Seen clearly in the video, were cough, vomiting, pallor, lethargy, rash, injection site rash, syncope, cold sweat, decreased appetite, anxiety, dizziness, nausea, abdominal pain, abdominal discomfort, aggravation of existing disease, excessive sweating, hives, muscle stiffness, chest discomfort. The worst on screen were seizure, appendicitis and a seperate loss of consciousness. Searching the batch number/adverse reaction table for 5-11 year olds in my own time, revealed reports of chest pain, syncope, anaphylactic reaction, paraesthesia, ECG ST segment elevation, nystagmus, pneumonia and many others. Some reports were of one reaction and others of multiple. All reports are of conditions children experience everywhere across the globe. Establishing cause or any relationship to COVID-19 vaccines is the role of health authorities.
Elsewhere on OpenDAEN we read that:
Useful search engines, graphs and tables have been developed into a helpful user-friendly database to assist study, research, review and analysis of the Australian Government publicly available data. […] We believe in sharing this information in an open and easy-to-use format (with search engines, tables and graphs etc.) and to help make it quicker for anyone wanting to source data for their own study, research and review.
The Quack Miranda
So, the team want to share information in a fast open and easy way to help with doing your own research. It sounds almost too good to be true. The Disclaimer and Disclosure tell us:
– Source: OpenDAEN –
Okay then. It is up to the user to get further professional information to confirm if the information is “of value to you”. Accuracy of the information cannot be guaranteed which places further responsibility on the user to seek advice before relying upon it. It’s information they might get wrong and as such will not be liable “for any loss, damage, cost or expense incurred” by reason of relying on that information.
It is 2024 and world search and data systems can perform enormous and complex requests with astonishing speed and accuracy, yet when Australian governments roll out never before used experimental gene therapies to millions of citizens, Australians are left to report to an antiquated adverse event reporting system (DAENs) still with both feet in last century.
This amounts to a fundamental failure of Pharmacovigilance and the Australian People. Searching through DAENs remains a nightmare for researchers, where one cannot but question the motivations of the TGA and the Australian health departments who feed it Our Information. OpenDAEN greatly assists researchers and students, and data and IT experts desperately needed to review and criticise the current DAEN system which is not fit for purpose.
Hopefully OpenDAEN will motivate Australian governments to take the needed steps towards a national real-time, transparent, and easily accessible adverse event reporting system, for properly protecting the health of Australians and better facilitating valid Informed Consent. The antiquated DAEN system deprives and seemingly hides needed health data necessary for Australians to provide valid Informed Consent.
COVID vaccine injury class action fund raiser, Dr. Melissa McCann writes:
This is amazing and meticulous work by you and your team.
Strong reminders of OpenVAERS and how decontextualised data are used by anti-vaccine activists to mislead, were apparent during the video. Alluding to what is known as the Lazarus Report, after the name of the principle investigator, one commenter offers:
– Facebook comment –
Suggesting that TGA DAEN statistics are only “(10%?)” of “ACTUAL injuries and deaths”, is linked to a bogus belief of widespread underreporting to VAERS in the USA. I addressed this in a post challenging OpenVAERS, writing.
The figure of 1% comes from a report from Harvard Pilgrim Health Care, Inc., authored by Ross Lazarus. Data examined are from 1 December 2007 to 30 September 2010. These data include all possible adverse events. Prior evaluation of the reporting rates of various events confirms that minor events are rarely reported and more serious events routinely reported. A 2014 report on surveillance of adverse events following immunisation in NSW, Australia noted that:
Only 11% of the reported adverse events were categorised as serious.
In short, most adverse events such as a sore arm, nausea, swelling, redness, headaches, vomiting and other self correcting issues are indeed underreported, but make up the vast bulk of adverse events following immunisation. Yet since the Lazarus report, anti-vaxxers love to spread tales of widespread death and terrifying injury, then solemnly add “only 1% are ever reported”.
Paul Offit is a strong supporter of VAERS which he refers to as a “hypothesis-generating mechanism”. Reports there of intussusception approximately once per 10,000 doses led to suspension of his own RotaShield vaccine which was ultimately recalled, before returning as a safe product. In fact health authorities want parents or doctors to report minor events as soon as possible. Much can be learned about self limiting reactions, and more concerning to severe reactions can be gauged by pattern changes, properly identified and suspended under section 29D of the Therapeutic Goods Act 1989.
Perhaps the most damning page on OpenDAEN is the resources page. A curated smattering of COVID-19 vaccine pseudoscience and “vaccine injury” class actions, peppered with all the anti-COVID mandate and health advice groups, it seems designed to lead readers into a field of gaping rabbit holes. Dr. Melissa McCann’s COVID class action vaccine injuries video tops the page. The World Council for Health Spike protein detox guide is there. R.F. Kennedy Jr.’s Children’s Health Defense Australia, The Zelenko Protocol, The Australian Medical Professionals Society, many of whom we’ve met here before, World of Wellness and the National Institute of Integrative Medicine to name a few.
Conclusion
OpenDAEN is not an exciting addition to the TGA DAEN database. It is not a positive, user-friendly addition to TGA staff or to genuine researchers and academics. It is created, managed, supported and provided by and for respectively, members of the anti-vaccine community, convinced that COVID-19 vaccines are the cause of multiple health ailments and death. No professionals were available for its launch. All invitations were ignored. It has no integrity and no academic standing. No coroners or State and Territory head pathologists will care.
Like its namesake in the USA, OpenVAERS, it is designed to allow users to gather misleading collections of coincidental report material and present this as causal COVID-19 vaccine adverse reactions. To be sure, the results it produces, easy to construct as they are, will find their way onto websites, social media and court affidavits. OpenDAEN won’t enjoy the success OpenVAERS did, because now only diehards remain. During the launch of OpeanDAEN, events two years old were focused on, to craft a demonstrably bogus, yet very serious accusation against COVID-19 vaccines.
Very late on Christmas Eve 2023, Santa had just dropped me a rather special present.
I more or less knew what it was by feeling the packaging, but still fumbled hastily until it sat gleaming in my hand. There it was. A brand new COVID-19 infection.
I could hear him jingling happily into the distance, with the words “naughty” and “nice” echoing on the breeze. Then, “falsifiable hypotheses” wafted back.
Of course! I suddenly remembered a discussion years ago, soaking our blistered feet in cured reindeer urine, when he told me anything that could be falsified was inherently “naughty”. Wrongly, I thought I had properly explained things to him.
This time, I’d sort him out. “Santa, Santa. I just KNOW we’ve had this conversation before”, I yelled in his direction.
I continued.
” Making a list, and checking it twice , gonna find out who’s naughty and nice… does not a falsifiable hypothesis make. I just… I mean, I can’t even….”.
He answered with a vague reference to falsifying anti-vaxxer claims and something even more vague about my feet needing another urine soak. Next thing an apparition-like, misty glob of reindeer, a sleigh, a fat, smelly-chap, sacks of presents and boxes of Rapid Antigen Tests was in front of me. Santa folded his arms and confidently started his defence.
I responded,
“Wait! What?! Say that again. I’ve been ‘naughty’, because I revealed falsification, and therefore I can’t enjoy Christmas this year? No, no dude, you’re attributing subjective emotional qualities to the entire notion of the falsibility hypothesis. Yeah I get it – you’re saying if I hadn’t showed things were totally false that I’d have been ‘nice’, particularly because you were checking it twice. But if I may, with respect old chap, it simply doesn’t work that way.”
He laughed, pointing at me, and asked, “Why the fud not?”
I was feeling far from well but managed.
“Well because, my long-bearded, voluminous-bellied friend. The very notion that the hypothesis can be falsified, is what lends it such robust integrity in the first place. Suggesting falsifiability is ‘naughty’ and anything not shown to be false is ‘nice’, is likely a position arrived at via a sequence of logical fallacies.
He said I was making some sense but sounding very lah-de-dah. So, I went on.
“Okay, let’s agree your position is that honesty or not ‘being false’, can be labelled very simply as ‘nice’. Cool? Righto then. And that dishonesty, or being deliberately false can be labelled as ‘naughty’. So, deliberate falsehoods coming from, ooh let’s say anti-vaxxers, are ‘naughty’. In fact they are known for providing so-called data based on fabrication, and fraud. So, let’s say ‘very naughty’.
Now, that all sounds okay, but it can’t really be tested beyond the scope of opinion. It also takes unnecessary work and lends credence to fraudsters. Better then, that the theory or hypothesis is one that can be tested and logically refute the idea being questioned, particularly if the falsification can be based on empiricism (what we see or experience).”
Santa asked if empiricism was like the Black Runes-of-Empiricism that Senator Malcolm Roberts used, to make a mockery of climate change.
“Why yes, you’ve heard of him then? A total… whoa, okay… sorry, yes, yes I did see the pontoons strapped to the sleigh. Bit sloshy up North… I can grasp that. Reality and Roberts don’t get on, Santa. Not a fan are we? No Ho, eh? Ah, well… er, no we can’t do the sword thing anymore. No, no the Blood Eagle never did take on down South. Sorry. Free speech and such. Oh? Well, um, I’d prefer to say we’ve become, “civilised” but “as sturdy as walrus diarrhoea” will do for any justified criticism in this case, old chap.”
Santa mumbled on about colourful torment to Roberts for a while, many involving objects I had never heard of, then he then gradually worked his way back to chatting about falsifying arguments and hypotheses.
I jumped in.
“So, see it’s simple really. If you can devise a method to falsify an argument that someone is proposing, then it is held to a greater standard of proof because it is possible to falsify it. Even if it has never been falsified. It just means it is possible to imagine or construct an argument to falsify it.”
I was by now feeling pretty crook and thought I might try my luck at swapping my present.
“Now Santa. Maaate, buddy, bloke. I realise we’re a long way from naughty and nice but I hope this clears things up, and clafifies the obvious error of this rather unique present you’ve dropped off. I guess this is one test I’d like to have seen falsified as it were… Nudge, nudge. Any chance you can wave the magic stocking..?
What’s that? Yes, yes, I did expose a bunch of anti-vaxxer arguments as false. They were false – fabricated in fact. In fact they were all bad. Thanks for noticing – it’s quite a long way for news to travel up North. What do you mean I’m still naughty? Er, yeah, okay… sure… But dude, I don’t CARE how many times you’re making a list, and checking it twice . Didn’t you understand a single thing we just discussed?
So, I’m what now? I’m too Skeptical? So I’m naughty because I’m too Skeptical? Oh, righty-Ho-Ho! What? Well, yes I’ve had a few COVID vaccines. Oh, I see that’s what this is. But I never said they were 100% protective; that’s an anti-vax logical fallacy. Gawd, Santa! Vaccines do reduce symptoms though. What? Well, er pretty sh*t actually. I’m running a temp of 39 C. But tomorrow I won’t be.”
Incredible! Santa seemed to be warming up to Gish gallop. Time to wrap this up.
“Anyway bloke. It’s getting late. Shouldn’t you be flying toward the West by now? Time zones and all that. You’re what?! You’re not flying!? Oh?
Entertainment for Skepticon’s Saturday night dinner, will be courtesy of Brisbane-based songwriter, musician and science communicator, Nate Eggins. In addition, Nate will also be one of the Skepticon MCs. With thought-provoking lyrics, Nate aims:
To encourage interest in science, promote critical thinking and with his quirky sense of humour, playfully nudge us to second-guess pseudoscience, modern advertising and conspiracy theories through fun catchy clever music.
Nate, a multi-instrumentalist, has used his talent and interest to create the solo project, Conspiracy of One. Described as A bit sciency, A bit funny,Conspiracy of One sold out two live performances at the Brisbane Planetarium, for the release of Nate’s debut album, Road To Reason.
Skeptics and fans of the Australian Skeptics podcast The Skeptic Zone are likely familiar with Nate’s 2021 hit, The Sound a Duck Makes. Indeed your “Quack!” vocal may well be on it. Road To Reason reflects Nate’s journey, “from the darkness of ignorance toward the light of scientific and critical thinking”.
Hit songs from the album include Can You Guess My Star Sign? which features Dr Karl Kruszelnicki, The Song THEY Don’t Want You To Hear and It’s Not You, It’s Corona. Great music and good humour with dinner, in the company of skeptics? Sounds like a great night.
You can learn more about Nate Eggins on his Facebook page, Instagram or check out some of his music on YouTube.
Making a list, 
and checking it twice 
, gonna find out 
Losing In The Lucky Country 