OpenDAEN: Misleading Australians

Posted in Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, Health, Immunisation, Legal, Scam, Science, Social Media by Paul Gallagher

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.

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.

If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible.

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.

For more information about the search results and how to interpret them, see: More about the DAEN – medicines
– Text from second DAEN disclaimer –

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 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:

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:

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.

The site has a small section on endorsements. The longest is from Julian Gillespie. Anti-COVID-19 vaccine researcher, legal consultant to the AVN, and Dr. Julian Fidge and author of a ridiculous IJVTPR paper, The Canaries in the Human DNA mine, Gillespie offers:

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:

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.

The colours are a nice change though.

Vaccine Safety Information You Can Trust

Last update: 2 February 2024

♠︎ ♠︎ ♠︎ ♠︎

31May2023

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

Posted in Alternative "medicine" scams, Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, General, Immunisation, Legal, Scam, Skeptic, Social Media by Paul Gallagher

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.

♠︎ ♠︎ ♠︎ ♠︎

27Mar2023

Ivermectin now a quack cure-all

Posted in Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, Health, Scam, Science, Skeptic, Social Media by Paul Gallagher

During the second and third years of the COVID pandemic, skeptics began to hear more and more of an anti-parasitic drug that had been used frequently for animals and less so for humans.

Ivermectin has been approved by health authorities to treat humans with strongyloidiasis and onchocerciasis (river blindness): conditions that are caused by parasitic worms. Also there are topical ivermectin preparations used to manage skin conditions such as rosacea and external parasites such as head lice. Used as prescribed it is quite safe and has improved the lives of countless individuals in developing nations. Yet we weren’t hearing about ivermectin used in this manner. Thanks to disinformation and irresponsible repetition of dubious claims, ivermectin was being promoted as a means to combat COVID-19.

The anti-vaccination movement embraced ivermectin because it resonated with the “my body, my choice” mantra. Right leaning media identities promoted it in much the same illogical way as they had hydroxychloroquine. It had been used safely for decades, they argued, and thus was clearly a sound choice to combat COVID-19 symptoms. Yet hydroxychloroquine, had a pharmaceutical history as an anti-malarial and an agent to manage symptoms of arthritis and autoimmune disease, not in treating COVID-19. Ivermectin similarly, had no clinically proven background in the treatment of COVID-19. The clinical trials had simply not been done.

For skeptics, the issue was and is quite simple. Look toward reputable sources. Seriously examine the arguments in favour of ivermectin. Review the strength of research being cited. Place the issue in context. Keep an eye out for ideology. Check the profiles and backgrounds of key players, and so on. In short: Seek the evidence.

Initially there was the 3 April 2020 media release from Monash University. The Monash Biomedicine Discovery Institute announced a paper published in the peer reviewed journal Antiviral Research. The title, The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, was tantalising. An informative piece published in the Sydney Morning Herald on 22 October 2021 cites experienced drug developer Dr. Craig Rayner referring to the impact of the announcement:

“It was incredibly hyped,” Dr Rayner said. “I knew it was going to start a fire.” […]

“It’s not the best thing for Australia to become known for in terms of its contribution to the pandemic,” Dr Rayner said. “But that’s what it is, unfortunately. It has promoted vaccine hesitancy and people are dying because they’re taking a veterinary medicine that has not been proven.”

For those looking to grab the ivermectin ball and run with it, the media release was peppered with big names, other nasty diseases and potentially exciting findings. It has since been modified to include an FDA warning and offer clear disclaimers about ivermectin’s effectiveness. What mattered to those who would go on to push ivermectin as a safe cure for COVID-19, came from just a few paragraphs:

A collaborative study led by the Monash Biomedicine Discovery Institute (BDI) with the Peter Doherty Institute of Infection and Immunity (Doherty Institute), a joint venture of the University of Melbourne and Royal Melbourne Hospital, has shown that an anti-parasitic drug already available around the world kills the virus within 48 hours.

The Monash Biomedicine Discovery Institute’s Dr Kylie Wagstaff, who led the study, said the scientists showed that the drug, Ivermectin, stopped the SARS-CoV-2 virus growing in cell culture within 48 hours.

“We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was a really significant reduction in it,” Dr Wagstaff said.

Ivermectin is an FDA-approved anti-parasitic drug that has also been shown to be effective in vitro against a broad range of viruses including HIV, Dengue, Influenza and Zika virus.

Dr Wagstaff cautioned that the tests conducted in the study were in vitro and that trials needed to be carried out in people.

For those of us even broadly familiar with how drugs are brought to market, it was that final line above that mattered. Early lab results do not equate to clinical trials. Indeed shortly after the announcement, effort and funding across the globe was directed to clinical trials of ivermectin. Yet it would take almost eighteen months before enough studies were done, presenting enough evidence to show that ivermectin does not hold promise as a treatment for COVID-19. Over 2021, the number of news articles heavily critical of the “dubious” apparent “miracle cure” rose steadily such as here, here and here. The BBC published a powerful article on the “false science” backing ivermectin. Flawed data, fake evidence and poorly designed and written research was common.

Australia watched on as Malcolm Roberts, George Christensen, Craig Kelly and Clive Palmer promoted (and still promote) ivermectin. In the absence of evidence ivermectin could not be prescribed for COVID-19. This led to proponents sourcing and ingesting veterinary-grade ivermectin. It soon became clear from social media that many were taking excessive doses very often. On 21 August 2021 the FDA tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” That tweet links to accurate FDA information on the dangers of using ivermectin.

You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) August 21, 2021

Finish reading “Ivermectin now a quack cure-all” at the Victorian Skeptics website…

28Feb2023

Woody’s wobble on Saturday Night Live

Posted in Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, General, Health, Media, Meryl Dorey, Social Media by Paul Gallagher

It only took a moment but it drew a lot of attention.

Woody Harrelson recently hosted Saturday Night Live for the fifth time. Five appearances is supposed to be memorable as lucky celebrities receive an “honorary jacket”. Yet Woody’s gig will be remembered for him donning the cloak of conspiracy theory (see what I did there), during his opening monologue. After some surprisingly ordinary pot-smoker jokes Woody told viewers about a film script he had read as he smoked a joint leaning against a tree in Central Park. The same joint we’d just met in a prior joke.

So, the movie goes like this: the biggest drug cartels in the world get together and buy up all the media and all the politicians and force all the people in the world to stay locked in their homes.

And people can only come out if they take the cartel’s drugs and keep taking them over and over.

I threw the script away. I mean, who’s going to believe that crazy idea?

I reckon like most people and virtually all Aussies, I was drawn to the SNL footage by the reaction it generated. I expected that Woody had hijacked the bulk of his monologue to chuckle through Ye Olde grab bag of COVID conspiracy smirk. Yet it was a tiresome old line: Big Pharma Control of government and media, purportedly being the real cause of COVID lockdowns, with an ultimate of profit. It fell rather flat on the audience.

Condemnation was swift. “Woody sprouts COVID conspiracy”, read Forbes. Vanity Fair told us he “really blew it”. People suggested he “sparks controversy supporting the COVID conspiracy theory”. SBS noted he “pushes conspiracy theories”. A quick Google search yields much more of the same. It’s pretty clear that rehashing COVID-19 fakery is not a way to win respect.

Yet as one might predict, the COVID conspiracy mob loved it. Avi Yemini tweeted “Woody Harrelson sums up the Covid scam perfectly”. His followers eagerly agreed, each chipping in some meaningless confirmation. One offered, “Now you know who was happy to sell you out for their own enrichment”, as if the pharma cartel conspiracy was a novel idea. The clip hit YouTube as supporters backed Woody for “telling the truth”, or dropping a “truth bomb”. Commenters adored him. Yet what really stood out is that COVID conspiracy theorists crave affirmation.

Woody Harrelson sums up the Covid scam perfectly pic.twitter.com/Isvyn4txn7
— Avi Yemini (@OzraeliAvi) February 26, 2023

Tireless anti-vaccine profiteer Meryl Dorey, took time off from her High Court mischief to write a post on Substack praising the embarrassing wobble. Woody Harrelson makes heads explode by telling the truth about COVID policies, her piece was headed. Meryl had also noticed the critical headlines and sagely observed, Truth is not the media’s friend. She went on to list a number of headlines variously dismissive of Harrelson’s “anti-vaccine” and “COVID-19 conspiracy theories” deemed “antivax nonsense”. Then as if to again confirm she rarely has a grasp of topics she claims to be expert in, Dorey writes:

Notably, the Youtube (sic) video on SNL’s own site had comments turned off but shows that there are over 27,000 likes and only 1 dislike. One has to wonder if producers are paying attention?

Actually one has to wonder if Meryl has been paying attention, because it’s been almost 16 months since YouTube removed public display of dislike counts. Making things worse, Meryl then referred to a video of Harrelson recently ranting to Bill Maher on Maher’s Club Random about Big Pharma profits, hydroxychloroquine and the unfortunate development when, “ivermectin got made into a horse tranquilliser”. Meryl hoped more “high-profile individuals” will follow his lead, because it might just make “complicity theorists” think. An absolute failure to read the room, as it were.

Cute terms like “complicity theorists” and the utterly boring repetition of thoroughly debunked claims seeking to cast doubt about the COVID-19 pandemic, the success of vaccination and the role of pharmaceutical companies are passé. Long gone are the days of potential recruitment to the cause of COVID conspiracy. All that’s left are the various misfits and cookers who cling to the idea that democracy is under threat, paedophiles are hiding children beneath the streets and our very status as free human beings needs to be fought for. Regrettably, there are those who continue to amplify absurd themes for their own profit.

The world is moving on from the initial, uncertain years of the COVID-19 pandemic. The frightening, dystopian world that conspiracy theorists insisted we were heading for never eventuated. All that’s left for them is to keep referring to past events in the hope of maintaining relevance. Harrelson’s SNL effort confirms this rather nicely.

It is quite apt that Woody Harrelson was trying to get laughs because one thing is quite clear: the continued obsession with COVID-19 conspiracies is nothing but a bad joke.

♠︎ ♠︎ ♠︎ ♠︎

Latest update: 2 March 2023

31Jan2023

Dr. Albert Stuart Reece again restricted by medical authorities

Posted in Anti-Drug Lobby, Drug Free Australia, Health, Human Rights, Illicit Drug Policy by Paul Gallagher

The Medical Board of Australia has placed fifteen limitations on the practice of Dr. Stuart Reece of Highgate Hill QLD. The conditions, enforced on 21 December 2022, have resulted in the temporary closure of the Southcity Medical Centre where Reece practices.

Reece (pictured) is a controversial figure in addiction medicine and a vocal critic of Australia’s successful policy of harm minimisation. He holds no formal qualifications in addiction medicine, but has authored or coauthored extensively on the subject, presently as an adjunct professor at UWA. Almost exclusively, his writings link illicit drug use, methadone and medical cannabis to death and disease.

Experts have refuted certain works as “reefer madness”. Reece has long associated his Christian faith with treating addiction. His book, titled “Let My People Go: A Theology of Addiction”, was published in 2016. His work is favoured by extreme anti-drug pressure group, Drug Free Australia, and frequently cited by them in lobbyist material, media replies and parliamentary submissions.

This is not the first time regulators have acted to ensure the safety of his patients. An article published on this blog in December 2011 examined his use of unapproved naltrexone implants and the deaths of 25 patients who had undergone the treatment. In 2009 Reece was suspended from practice for supplying morphine to opiate dependent patients and falsifying records to disguise the fact. This was because of his ideological opposition to evidence backed methadone maintenance therapy. That suspension was in turn suspended for three years.

The Medical Board of QLD, Health Practitioners Tribunal observed at the time that Reece:

… has a somewhat evangelical approach to this area of medicine and because of that he does appear to lack a degree of insight and objectivity in relation to the treatment of his patients. Furthermore, he seems to feel that the ends justify the means in terms of treatment of patients.

Today, the catalyst for intervention includes the number of patients being bulk billed per hour and quality of care. This is reflected in the limitations on practice (complete list in slideshow below).

1. The Practitioner must not exceed four (4) of patient consultations in any one hour (60 minutes). […]

5. The Practitioner must only practise as a general practitioner when supervised by another registered medical practitioner with knowledge and experience in addiction medicine (the supervisor).
For the purposes of this condition, ‘supervised’ is defined as:
The Practitioner must consult with the supervisor who is always physically present in the workplace and available to observe and discuss the management of patients and/or performance of the Practitioner when necessary and otherwise at weekly intervals. […]

7. In the event that no approved supervisor is willing or able to provide the supervision required the Practitioner must cease practice immediately and must not resume practice until a new supervisor has been nominated by the Practitioner and approved by the Board.

A search for general practitioners providing services in addiction medicine in the Brisbane area yields modest results. There just isn’t enough practitioners providing these select services across Australia. If one adds the fact that such providers have often taken on all the patients they can, it isn’t beyond comprehension that Dr. Reece is unable to find a supervisor. Reece has loyal supporters amongst his patients, who have a Facebook page here. They have argued in a petition that finding a supervisor is “an impossibility”. The petition, “Reinstate Dr. Stuart Reece Immediately”, contends that the predictable lack of a supervisor indicates that the action taken is about the control of services offered under bulk billing.

AHPRA is also advising that Dr Reece must have another Doctor with him for consultations into the future to oversee his work to their satisfaction. This requirement is an impossibility. AHPRA and Dr Reece both know that this doctor does not exist. There is not a ‘spare doctor’ lying around that is available for this. […]

THIS IS NOT ABOUT PATIENT CARE OR BETTER HEALTH OUTCOMES. THIS APPEARS TO BE ABOUT CONTROL OF THE TYPE OF SERVICES OFFERED TO PATIENTS WHO NEED BULK BILLED DOCTORS.

The petition is a long heartfelt plea seeking to justify the way Reece operates his practice. It makes the point that certain appointments, particularly prescription refills, may require only five minutes. The petition also notes that Reece would be forced to close his doors in part because, “his practice would be limited dramatically by the immediate reduction of the number of patients he is able to see daily…”. Whilst I empathise greatly with these patients and find removal of any addiction treatment services troubling, one cannot escape the fact that such a huge patient load should never have eventuated. Health Practitioner Regulations state, “A Practitioner must NOT exceed four (4) patient consultations in any one hour (60 minutes)”.

There’s no doubt that Medicare is not meeting the needs of Australian General Practitioners. The patient rebate is beyond inadequate, being markedly out of step with the Consumer Price Index (CPI). This manifests in significantly fewer consultations being bulk billed, and in many practices fees now apply to concession card holders. For Australians surviving on the aged or disability support pensions a visit to their GP is now financially prohibitive. The end result is a health system under strain. However there comes a point where increased patient quantity, means decreased quality of care. Let’s remember that the Health Practitioners Tribunal observed in 2009 that when it came to treating patients Reece lacked insight and objectivity, and felt the ends justified the means. The same document notes (point 22):

He does provide care to a large number of detoxifying and drug dependent patients. In June 2009, alone, he had 409 Subutex patients in Queensland and I understand the numbers are larger at the moment. From 2001 to 2007 he was responsible for 8681 registrations of opiate withdrawal registrations in Queensland.

Arguably, Reece is the architect of his own professional distress. As noted above, in November 2009 the practice suspension applied to Reece was itself suspended for three years. Yet less than two years later there was no tone of contrition for falsifying medical records to supply opioid dependent patients with morphine. The occasion was a Senate Inquiry into the Professional Services Review (PSR) Scheme, to which Reece, representing the now defunct Australian Doctors Union, made a submission. Bear in mind Reece has today been saddled with limitations to prevent excessive bulk billing at the expense of Medicare. The PSR “aims to protect the Australian public from the risks and costs associated with inappropriate practice within Medicare…”. Reece began his submission:

Prof. Reece: The Australian Doctors Union is a nascent union which has come together to support each other through the nightmare experience of PSR’s incompetence, lies, intimidation and bullying. In addition to doctors damaged by—

CHAIR: Hang on please. That is making accusations and it is not the way that we take evidence. If you could please refrain from using that sort of language, that would be appreciated.

Reece continued for a full five minutes explaining why he believes the PSR “has been shown to be waging a very successful war against general practice in this country”. He blamed the PSR for doctor suicides, marriage breakdowns, a lowered bulk billing rate, marginalisation of women, being racist, sexist and for damaging “many excellent doctors”. One of these was his ideological colleague, “Dr George O’Neil of naltrexone implant and detox fame”. Despite the fact naltrexone implants are not TGA approved Reece felt O’Neil should have been assisted by Medicare. Perhaps most alarming was when Reece included himself as one of those excellent doctors. Referring to himself in the third person, he humbly submitted:

Associate Professor Stuart Reece, one of the foremost detox doctors in the nation and a world authority on the long-term effects of opiate addiction.

This dear reader, is the crux of the matter. Stuart Reece is not a world authority on the long term effects of opiate addiction. In 2007 he opposed needle-syringe programmes, methadone maintenance therapy and the policy of harm minimisation in general. He informed a parliamentary inquiry that condom use was linked to AIDS deaths. Yet in June 2009 Reece was managing 409 Subutex patients. Buprenorphine is the opioid in Subutex and today it is distributed in combination with naloxone under the brand name Suboxone. It is a successful mainstay of substitution therapy for opioid dependent patients seeking to manage addiction and eventually cease opioid use. It is a key element of harm minimisation.

Exactly how a strident opponent of harm minimisation has today found himself with so many opioid substitution patients that Ahpra require supervision and auditing of him, is baffling. It may however have something to do with the attitude toward Medicare and the PSR Scheme reflected in his 2009 submission. Or his 2012 comment, What is wrong with medicare? (p. 170) bemoaning the PSR and Medicare audits. It may also have something to do with the disdain Reece has for evidence based health policy and genuine, original research. Reece has spent a career convinced he simply knows better. Better than the bulk of his colleagues, better than global research trends and better than health authorities. In short, Stuart Reece is the cause of the dilemma faced by so many of his patients.

Having said that, one cannot deny that Reece and Southcity Medical Centre have been accomodating the needs of a great many patients. An excessive number of patients. However accounts such as this on reddit aren’t isolated. They suggest the practice is busy, waiting times are high but Reece is attentive and compassionate. Google reviews are more varied. According to the petition there are 1100 patients in need of treatment. Over the last 18 days, 224 people have signed. The goal is presently 500.

Ultimately this situation doesn’t bode well for these patients. It is doubly sad that many are not able to see that the cause of their problem is Stuart Reece himself and not Ahpra. Funnelling high numbers of vulnerable in-need, at-risk patients through the surgery is far from acceptable. The only way forward is to abide by the limitations. Anything less is to abandon his patients.

Stuart Reece must accept that the ends do not justify the means. It is time to place patients first.

Medical Board of Australia restrictions imposed on Dr. Stuart Reece