Coronavirus pandemic prompts increased transparency of drug companies

The unprecedented nature of the SARS-CoV-2 coronavirus pandemic has begun to influence the transparency of drug company trials of potential COVID-19 vaccines.

On September 17th The New York Times reported that Moderna and Pfizer were releasing the protocols that describe the trial process to test a potential COVID-19 vaccine. On September 19th they reported that AstraZeneca had done the same. This heralds a significant change on the part of drug companies. Although in practice complex vaccine trial protocols would need to be interpreted by say, science journalists, in order to be understood by the wider public particularly given the multicultural nature of today’s communities in developed nations.  [See references below for protocols]

As trials have progressed to Phase III in which data on the safety and efficacy of vaccines are collated, the interest of the public has grown significantly. Intense media attention surrounded the recent pause of the Phase III trial of the vaccine being developed by AstraZeneca in partnership with scientists from Oxford University. Not surprisingly public interest has turned to pressure for more transparency as to how trials are conducted.

From July 24th to August 7th Ipsos surveyed respondents from 27 countries [PDF] on attitudes toward a COVID-19 vaccine. 74% of respondents said they would have a vaccine if it was available. The most common reason for rejecting the vaccine was concern over side effects (56%). This was followed by doubt of its effectiveness (29%). The importance of transparency surrounding Phase III trials is confirmed by the weight of these two reasons for rejecting the vaccine.

These vaccines are being developed rapidly under the gaze of a public that expects at some time to be given such a vaccine. It’s understandable that anxiety surrounding both efficacy and safety of COVID-19 vaccines existed long before the specifics of Phase III trials became public. That those specifics have become better understood due to an issue with safety does raise matters of trust within the public.

Of course the increased attention over safety and efficacy would never have arisen during development of the many so-called “alternatives” to regulated vaccines. Alternative products are not subject to reliable scrutiny and as such the acute and chronic effects are in fact undocumented or unknown. The safety and efficacy of such listed (as opposed to regulated) therapeutic products is almost always merely assumed.

Establishing trust between the public and the government and health authorities is important. Increased transparency of vaccine trials will help promote trust. Sustaining trust is significantly reliant on clear information and explanation of complicated issues that raise public concern. This is particularly true in the present environment where changing evidence may come across as inconsistency and if left unacknowledged may lead to suspicion. The proper interpretation and presentation of available information is essential.

Normally data gathered during a trial are published after the trial. However the dynamic nature of COVID-19 vaccine development and the global impact of this pandemic have already changed what may be considered normal. Added to this is information that is leaking out. The Oxford trial has recommenced on the advice of an independent safety committee. AstraZeneca announced that they “had not confirmed a diagnosis” of transverse myelitis in the study volunteer.

What has also recently become apparent is that the study was paused in July after a male volunteer who had received one dose of the vaccine developed transverse myelitis. See page 10 of this participant information sheet. There was a review by independent experts. The trial resumed after it was determined that the individual had a previously undiagnosed case of multiple sclerosis unrelated to the vaccine. Still, there was a persistent concern that AstraZeneca had not revealed in detail what had happened to the woman whose significant neurological symptoms led to the most recent trial pause.

On the September 14th edition of The Health Report Dr. Norman Swan interviewed Professor Bruce Neal, Executive Director of the George Institute Australia. The occasion was to discuss the launch of a project called Join Us. A challenging issue about Phase III trials is that drug or vaccine development may stall or fail due to lack of suitable participants. This isn’t due to drop out or resistance. Rather the cost and administrative difficulty of finding suitable participants is significant. Join Us aims to secure pre-consent to trials of a certain nature.

Whilst that’s interesting information about trials, Swan also asked Professor Neal about his thoughts on the reluctance of AstraZeneca to reveal details about the woman responsible for the second pause of the Phase III trial. Neal considered reasons to release more information. It would give a heads up to other researchers around the globe allowing them to “provide input and information into it”. However he also noted that releasing such information midway through a trial may have negative consequences.

There may be confidentiality issues as such a “severe unusual event” might lead to patient identity being leaked. Perhaps most interestingly was the observation that the trial may well end with a conclusion that the event was not an issue related to the vaccine. By then the damage is done. The public have already internalised the notion of a negative side effect. The media effort to reverse that belief is not likely to be successful.

Professor Neal stated;

And so the media surrounding the announcement of something like that is going to retain much more prominence probably than the media that tries to reel that back in and say, look, actually it wasn’t an issue. And that could have ramifications down the track when you try to get people to take the vaccine.

It’s important to note that the FDA has not allowed the AstraZeneca trial to resume in the US. The National Institutes of Health stated that it remains to be seen if the illnesses are coincidental and that, “pausing to allow for further evaluation is consistent with standard practice”.

Understandably some health professionals in the US remain concerned. Whilst investors were told of the second problem it has become clear that the company did not immediately alert the F.D.A. and advise them of the independent safety board’s recommendation to pause the trial. Virologist Dr. Peter Jay Hotez based at Houston’s Baylor college of Medicine has not been impressed. He claimed communication has been “horrible and unacceptable” citing the failure of UK regulators to provide rationale for resumption of the trial.

The New York Times also reported;

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s advisory committee on vaccines, said that it’s unclear how the company — or the U.K. government — determined that the second case was not related to the vaccine.

Offit has also noted that the rarity of transverse myelitis in the general public has not been reflected in the UK trial population. The extra caution we are seeing in the US is reason for the public to have increased confidence in the influence regulators have over the safety of vaccine trials. Consequently there is reason for the public to be less anxious about the safety of COVID-19 vaccines that are eventually marketed. Given that independent safety experts in the UK have advised it is safe for the Oxford trial to resume it will be very interesting to see what further evaluation by US authorities concludes.

There has been research into immunisation and the likelihood of subsequent development of transverse myelitis (TM) and acute disseminated encephalomyelitis (ADEM). Key points from the 2016 paper Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis are as follows;

Results: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. […]

Conclusions: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered.

Acknowledging vaccine safety concerns as a cause of vaccine hesitancy, in July this year Nicola Principi and Susanna Esposito published a narrative review, Do Vaccines Have a Role as a Cause Of Autoimmune Neurological Syndromes?

The authors wrote in part in their abstract;

Only well-conducted epidemiological studies with adequate evaluation of results can clarify whether a true association between vaccines and adverse event development truly exists. Autoimmune neurological syndromes that follow vaccine use are among these. […]

Literature analysis showed that most of the associations between vaccines and nervous system autoimmune syndromes that have been reported as severe adverse events following immunization are no longer evidenced when well-conducted epidemiological studies are carried out. Although the rarity of autoimmune diseases makes it difficult to strictly exclude that, albeit exceptionally, some vaccines may induce an autoimmune neurological disease, no definitive demonstration of a potential role of vaccines in causing autoimmune neurological syndromes is presently available. Consequently, the fear of neurological autoimmune disease cannot limit the use of the most important preventive measure presently available against infectious diseases.

The Institute for Vaccine Safety at Johns Hopkins University logically argues that a number of vaccines “may prevent transverse myelitis”. The institute published Do Vaccines Cause Transverse Myelitis? Last updated September 18th 2020 the article opens with the conclusion;

Natural viral infections with influenza, hepatitis A, measles, mumps and rubella and varicella have all been associated with myelitis, albeit rarely. Thus, these viral vaccines may prevent transverse myelitis by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.

Ultimately this research in conjunction with the cautious US approach at present does not support a contention of general recklessness in the production of this vaccine or of other potential COVID-19 vaccines.

This dynamic provides yet another blow to anti-vaccination conspiracies. Namely the contention that there is collusion between drug companies and health regulators to suppress the supposedly inherent dangers of vaccines that anti-vaxxers wrongly insist lead to an abundance of vaccine injuries. More so Dr. Paul Offit has been derided, verbally attacked and threatened by the global anti-vaccine lobby for many years as a callous profiteer of vaccines. Yet he has constantly raised a voice of caution to ensure safe COVID-19 vaccine development.

It is certain that placing the AstraZeneca trial on hold following advice from the F.D.A. is not a unique event. Rather the fact that measures employed to control the current pandemic are being played out before the public in real time has provided insight into events that are usually ignored. In the previous post I listed some other aspects of anti-vaccine conspiracy that simply cannot be sustained following media reports of the AstraZeneca/Oxford Phase III trial pause. Even cursory attention to the details of this trial has exposed the dishonesty of anti-vaxxer claims.

Well before the trial pause led to media attention, public anxiety and now transparency of drug companies, the importance of trust in accepting a COVID-19 vaccine had been raised in Australia. Prime Minister Scott Morrison made a significant mistake with respect to public confidence in vaccine development and uptake. In August he announced that Australia had signed a deal to produce the vaccine being developed at Oxford University if Phase III trials were successful.

His mistake was to add that it would be “as mandatory as you can possibly make it”. Morrison realised the mistake and in under a day had produced the anticipated walk back. Nonetheless the many anti-science and anti-reason groups that are feverishly misrepresenting the motives of governments and health authorities during this pandemic were delighted. Within hours of Morrison’s announcement the AVN published a video mocking the notion of “safe and effective” vaccines whilst contending they “had always known this was coming”.

There were of course no “walk backs” from the AVN when Morrison corrected his position. Pushing fear of mandatory vaccination has always translated to profit for this group and Scott Morrison had done them a favour. Say no to mandatory vaccination read the back of a T-Shirt weeks later in Perth during Australia-wide “solidarity” rallies. Messages on social media continue in the same vein. Still, the reality is that messages and memes on mandatory vaccination would be common had Scott Morrison made no such statement.

Any harm done to the uptake of a COVID-19 vaccine in Australia is likely negligible. A survey conducted in April found that just under 86% of Australians aged over 18 would get a COVID-19 vaccine. 4.9% would not whilst 9.4% were indifferent. These figures are promising but were collated before the widely publicised pause in the AstraZeneca trial and increased public reflection on the safety of a COVID-19 vaccine. Survey responses were to the statement, If a COVID-19 vaccine becomes available, I will get it.

Ipsos published their global attitudes results on September 1st, indicating an 88% uptake of a COVID-19 vaccine in Australia. 59% strongly agree and 28% somewhat agree with the statement, If a vaccine for COVID-19 were available, I would get it. Only China and Brazil were more likely to accept a vaccine. These figures were also collated before the pause in the AstraZeneca trial. Follow this link to read Key Findings for Australia.

Another area that’s causing anxiety is the posturing of Donald Trump toward authorising a COVID-19 vaccine before the upcoming election. Consider the measure of Trump for a moment. He will tempt the voters with the promise of a vaccine in weeks. However it is more realistic to expect a safe and effective COVID-19 vaccine in months. These promises demand a disregard for vaccine safety. Yet in March 2014 Trump was tweeting in support of the mythical vaccine/autism link, a bogus view that bemoans a lack of vaccine safety. After the last election, research fraud and vaccine/autism profiteer Andrew Wakefield attended an inaugural ball from which he posted a social media video calling for an overhaul of the CDC.

Others have long ago considered the measure of Trump in regard to the election and a COVID-19 vaccine promise. In early June University of Pennsylvania professors Dr. Paul Offit and Dr. Ezekiel Emanuel wrote an opinion piece in The New York Times entitled Could Trump turn a vaccine into a campaign stunt?

It included;

In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. […]

Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. […]

Thousands of Americans have already died as Donald Trump has perpetually postponed effective public health interventions and made poor therapeutic recommendations. We must be on alert to prevent him from corrupting the rigorous assessment of safety and effectiveness of Covid-19 vaccines in order to pull an October vaccine surprise to try to win re-election.

At the beginning of the second week of September the CEOs of nine drug companies, arguably competing in the development of a COVID-19 vaccine, signed a pledge to stand with science and not launch such a vaccine until it met “high ethical standards and sound scientific principles”. The pledge statement as it appears on Pfizers website is in references below. It came at a time when public health specialists and scientists expressed concern that the Trump administration was pressuring regulators to authorise a vaccine before the November 3rd election.

The New York Times reported;

The joint statement by competitors was seen as an effort to restore public trust as President Trump has pushed for a vaccine before the presidential election.

An out-take from the pledge from Pfizer’s website is as follows;

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

  • Always make the safety and well-being of vaccinated individuals our top priority.
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

Yes to the cynical eye this may seem to present the pharmaceutical CEOs as really great guys. However I recommend reading the entire Biopharma Leaders Unite pledge. More to the point with increased transparency the public and the media have an invested interest to see a suitable outcome here. This pledge is certainly a step up from Fauci saying he has “confidence and some faith” that the COVID-19 vaccine approval won’t be political.

Earlier in the year it was reported that a significant number of Americans are likely to refuse a COVID-19 vaccine. A robust anti-vaccination lobby and rising numbers of the vaccine hesitant mean that the number of Americans who accept the vaccine may be insufficient to sustain herd immunity, which may require between 50 – 70% of the population to be immune. The more recent Ipsos survey found 67% of US citizens would have the vaccine.

Exactly how many must be vaccinated to achieve herd immunity is still uncertain. The WHO suggest 95%. Mathematical modelling reflecting age and social activity level produces a herd immunity “illustration” as low as 43%. Other reports suggest a vaccine uptake of over 70% is needed. The Mayo clinic point out that reaching this level of immunity through infection and not vaccination would overwhelm the health system and cause millions of deaths.

Thus there is ample reason to hope greater transparency of vaccine trials leads to justified improved confidence in the safety and efficacy of COVID-19 vaccines and increased uptake. Of course given the speed of current COVID-19 vaccine trials let us also hope that the vaccines that make it to market are extremely safe and splendidly effective. The fewer challenges that accompany immunisation on a global scale the better.

Another area that is getting more scrutiny if not exactly transparency is that of vaccine nationalism. This term refers to agreements between governments and vaccine manufacturers that ensure developed nations have secure access to vaccines for their entire population before they are available for other nations. With COVID-19 this may result in a delay in vaccinating health workers in developing nations, individuals at high risk of severe disease or death and those living in a region of a sudden dangerous cluster.

COVID-19 is a global pandemic. Yet we are faced with a situation where wealthy nations will be able to vaccinate their populations whilst countries that rely on aid organisations will be unable to vaccinate health workers and at-risk populations without organised help. A recent Science Friction podcast looks at the ways in which this problem can be combated. Australia’s Friends of Science in Medicine actively support equitable access to “COVID-19 vaccines and related health technologies”.

No doubt the anti-vaccine lobby will use information in the trial protocols in the same way they use vaccine package inserts. Thanks to exceptional cognitive dissonance they will list reasons as to why information from vaccine manufacturers can’t be trusted whilst using that same information to defend these reasons. The good news is that as we’ve seen, increased transparency and media attention has exposed tenets of anti-vaccine conspiracy and beliefs as vacuous and fallacious. On these points it’s a case of watch this space.

In conclusion it can be seen that the increase in transparency of COVID-19 vaccine development should indeed serve to increase public trust and confidence in the quality of eligible vaccines. I cannot finish without stressing again that the safety and efficacy elements of Phase III trials do not apply to the raft of concoctions marketed as alternatives to medicine. All consumers should seek reputable sources of information and beware of the many hoax “cures” of COVID-19. Discuss any novel plans to manage or prevent COVID-19 with a registered medical practitioner.

Finally whilst the importance of transparency with respect to vaccine trials has become clear, it was also confirmed by the Ipsos global survey on attitudes to a COVID-19 vaccine. The most common reasons for intending to refuse a vaccine are safety followed by efficacy. The establishment of which is the very aim of Phase III trials.


REFERENCES

Phase 3 clinical trial of investigational vaccine for COVID-19 begins

Moderna Clinical Trial Protocol – SARS-CoV-2 vaccine

Pfizer Clinical Trial Protocol – SARS-CoV-2 RNA vaccine

AstraZeneca Clinical Trial Protocol – COVID-19 vaccine

Oxford Vaccine Trials – Participant Information Sheet: COV002 (July 2020)

Oxford Vaccine Trials – Participant Information Sheet: COV002 (Sept. 2020)

Willingness to vaccinate against COVID-19 in Australia

9 in 10 Australians say they would get vaccinated for COVID-19 – Ipsos

Global attitudes on a COVID-19 vaccine – Ipsos [PDF]

A future vaccination campaign against COVID-19 at risk of vaccine hesitancy and politicisation

Biopharma Leaders Unite To Stand With Science – Pfizer

Moderna and Pfizer reveal secret blueprints for coronavirus vaccine trials – NYT

AstraZeneca under fire for vaccine safety releases trial blueprints – NYT

Do Vaccines Cause Transverse Myelitis? – Institute for Vaccine Safety, John Hopkins University Dept. of International Health

Acute demyelinating events following vaccines: a case-centered analysis
– DOI: 10.1093/cid/ciw607

Do vaccines have a role as a cause of autoimmune neurological syndromes?
– DOI: 10.3389/fpubh.2020.00361

FSM supports equitable access to COVID-19 vaccines

Vaccine nationalism threatens global plan to distribute COVID-19 shots fairly

The rise of vaccine nationalism – should we be worried? – ABC Podcast

Herd Immunity: Understanding COVID-19 – DOI: 10.1016/j.immuni.2020.04.012

Wearing masks does not cause staphylococcus infection or CO2 toxicity

On August 20th I was passing through AVN Facebook territory and noticed the image below had been posted in the comments section of a post citing a Daily Telegraph news article. The article was about the likelihood of a free COVID-19 vaccine in Australia.

It included this shin kick for anti-vaxxers;

Can there be anything more satisfying than the dangerous, hypocritical and unspeakably cruel anti-vaxxer mob in full self-combust mode at news that the rest of us — the sensible Australians — are delighted to hear?
The only national glimmer of hope in this coronavirus war on our bodies, livelihoods and mental health has been the promise of a free vaccine available eventually to all Australians, writes Louise Roberts

The post urged readers to include their thoughts. One of which was this image;

image falsely linking skin conditions to mask wearing

Fake “Mask Induced Staphylococcus” scam

Firstly the claim of lung infections and loss of consciousness due to restricted airflow from masks has been debunked. This claim as pushed on social media relies on the belief that masks cause CO2 toxicity, known as hypercapnia.

In very, very rare cases with an open wound and a dirty mask contaminated with staph bacteria one may develop a staphylococcus infection from masks. Nonetheless, what’s important is dealing with the claim in the context of the images above. Simply put the claim is that these are examples of “staphylococcus from masks”.

This claim of staphylococcus infection from masks is as offensive as it is bogus. It is a textbook example of what goes wrong when one trusts social media as a source of news or facts. Particularly social media outlets of groups that use the term “fake news” to describe genuine media presenting facts they disagree with. Yes indeed, verily this describes the Australian Vaccination-risks Network.

Staphylococcus infection is described by the Mayo Clinic in these opening paragraphs as follows;

Staph infections are caused by staphylococcus bacteria, types of germs commonly found on the skin or in the nose of even healthy individuals. Most of the time, these bacteria cause no problems or result in relatively minor skin infections.

But staph infections can turn deadly if the bacteria invade deeper into your body, entering your bloodstream, joints, bones, lungs or heart. A growing number of otherwise healthy people are developing life-threatening staph infections.

The article continues to list symptoms, types of infections, causes, invasive devices and treatment.

Merck Manual also has an excellent article by Larry Bush M.D. which was updated just over a year ago. The important point here is that consulting articles on staph infection reveals facts specific to the diseases that result and the lack of any information confirming that the wearing of surgical masks is responsible. So this nonsense is predetermined disinformation designed to sabotage public health measures.

When it comes to challenging an image “collage” like the above taking a screenshot of each image and doing a reverse image search via Google or TinEye yields ample insight into the mind of COVID-19 conspiracy promoters. Taking the middle right image we find pages of results devoted to articles on exhausted doctors wearing PPE and working long hours during the height of Italy’s struggle with COVID-19. The initial post of Italian nurse Valeria Zedde was made by her on Instagram. Other photos capturing the impact of long term PPE use can be found online including these on Twitter.
italian doctor after long shift with covid patients

Italian nurse after hours wearing PPE

The face above the hard working nurse is from a Wikipedia post on Eczema herpeticum. This infection may be caused by a herpes simplex virus, coxsackievirus or vaccinia virus. The image file was uploaded on April 11th 2018 as is clear on this Wikimedia commons page. The image is cropped in the scam staphylococcus collage above to give the appearance of a mask infliction but more importantly to hide the eyes which help confirm this child is certainly under five years of age.

The WHO have published a Q&A on children and mask wearing due to COVID-19. They clearly state;

In general, children aged 5 years and under should not be required to wear masks.

Ah well, nice try. Still, no amount of cropping can hide the fact this image was uploaded 18 months before the first case of COVID-19 in Wuhan in December 2019.

Eczema herpeticum on childs face

Eczema Herpeticum

On the subject of cropped images we can trace the image at bottom right to an article in Medical News Today describing Malar rash. In the case of this subject the rash is caused by a condition known as rosacea. More so the lady appears in a large number of Alamy stock photos with a caption plainly stating her condition is rosacea characterised by facial redness, small and superficial dilated blood vessels.

Whilst determining the exact origin of Malar rash is difficult due to a large number of candidate causes, turning into a strange looking case of staphylococcus due to wearing a surgical mask is not one.

case of malar rash

Malar Rash – Source Medical News Today

The condition in the image at bottom left may well have been determined by you as the case of varicella (chicken pox) that it is. The Getty images iStock photo also appears on Pinterest with no watermark where anyone with an account can take a screenshot of the image at not cost.

It’s interesting that with this image the cropped version used in the scam collage also removes any helpful identifying features to help one conclude this is a young child.

child with chicken pox pimples/varicella

Chicken Pox / Varicella pimples on female child

The final image is the one at top left. In fact this image is the only one that may have substance. The French teenager in the image claims to have had an allergic reaction to wearing a sheet mask for a prolonged period of time.

With help from Google Translate we see that Le Monde newspaper reported;

According to the mother, the 12-year-old wore a sheet mask for several hours on vacation: “This is the first time she has worn this mask provided by her college for so long. We went on a camping holiday for a week, and the mask was mandatory in closed areas, so she had to put it on every day”. […]

Beware of hasty conclusions, however. “There may be intolerance reactions to the mask that are not allergic reactions. The mere fact that it is red is not enough to say that a mask contains an allergenic substance”, tempers Brigitte Milpied, dermatologist at Bordeaux University Hospital and member of the French Dermatology Society (SFD). “Whenever something goes wrong, people tend to call it an allergy. However, the allergy remains exceptional. To be sure, you have to do a test” she adds.

Doctor Hervé Masson, allergist in Bordeaux, shares this opinion: “In the image, it looks more like a burn than an allergic reaction, but as long as the child has not been examined, we cannot tell”. […]

allergic reaction to wearing the same surgical mask for extended time

Claimed allergic reaction – prolonged mask wearing

The importance of wearing a proper, clean mask and discarding of disposable masks when they are moist or soiled can’t be understated. If a genuine allergic reaction, the image above raises questions about just how well informed this teenager and her parents were about hygienic mask wearing, maintenance and disposal.

It’s important to wash cotton masks before wearing them and to not exceed recommended duration of wear. Individuals prone to allergies may have to test materials and take extra precautions. Information as to how to avoid allergic reactions from wearing masks should be clearly conveyed by health authorities in all languages used in the release of other COVID-19 information.

The good news is that this particular effort to scare the unsuspecting into believing masks cause staph infections or CO2 toxicity has been thoroughly debunked. Either through sourcing the images or combining this with facts about CO2 toxicity and mask wearing. Please check the excellent sources below

No doubt COVID-19 related scams and disinformation will continue in the foreseen future.


David Attenborough presents “Migration of the Skeptic”

This is a rather short presentation on the somewhat rare migration of that strange creature, the skeptic.

This strange, pedantic being prone to seek out evidence is often accused of being at the heart of invented conspiracies. This accusation is particularly true of reality-adverse groups such as herbalists, antivaccinationists, chiropractors, homeopaths and many others who peddle fallacious claims devoid of evidence. It seems the innocent skeptic is motivated by an innate drive to challenge such obvious hanky panky.

This video focuses on a number of their distinguishing features and, when considered in full, highlights the ability of skeptics to take the piss out of themselves.

 

A Little Boy Lost and the Goat in the Sheep’s paddock

A few days ago Australia’s Seven Network screened Saving Chase as the subject of their Sunday Night programme.

The general plight of Chase can be gleaned from watching the programme. However this hasn’t just happened in the last few weeks. More so in no way, as Melissa Doyle tells viewers during the introduction, is this “a classic case of what would you do?”. Indeed Doyle confirms this in her next statement.

A child just four years old suffering from a serious disability. He is distressed, in constant pain and gripped by violent, uncontrollable seizures. Understandably his parents want him to be well and happy like other little boys. In desperation they abandoned traditional style medicine and turned to a bizarre hippy-style church for help.

The question rather, is “How can any parent subject their innocent, vulnerable, high needs child to the unverified guesswork pushed upon him by a reckless, dangerous and deregistered doctor who had caused “catastrophic” injuries through administering cannabis oil to prior patients?

https://youtu.be/xs4bhovdfG0

Arrogant, unrepentant and angry with the demands of genuine medical science, Andrew Katelaris, the so-called Dr. Pot is the last person who should be anywhere near a fragile child like Chase. Presently as a result of his disdain for medicine and accountability Katelaris is “permanently prohibited from supplying or administering cannabis or any of its derivatives to any person for the treatment or purported treatment of cancer”.

It appears to be a very thin line that he is walking on.

Despite being deregistered for breaking the law in 2005, Katelaris last year managed to break the law for non-registered health practitioners. He injected cannabis oil into two women suffering from ovarian cancer, in what was described as “a hasty, ill-conceived and unsafe clinical trial of injected cannabis oil as a treatment for malignant ascites”.

The ABC reported in part;

The NSW Health Care Complaints Commission concluded Dr Katelaris put his own interest in self-protection and self-promotion ahead of the health and safety of two vulnerable women suffering from ovarian cancer.

It found he posed a risk to the health and safety of members of the public, prompting him to be permanently prohibited from supplying or administering cannabis or any of its derivatives, to any person for the treatment or purported treatment of cancer.

The full HCCC finding published on October 25 2016 may be found here.

As is plain in the video Katelaris deems himself right and everyone else wrong when it comes to his use, or rather abuse, of cannabis. It’s impossible to call his guesswork the “medicinal” use of cannabis. Katelaris conducts no trials, keeps no clinical notes, takes no measurements and lacks the use of basic statistical models. As the HCCC noted last year in describing his bogus “trial” it lacked credibility, authorisation, scientific legitimacy or ethics approval. The best he could offer reporter Alex Cullen with regards to efficacy was that he sees results. However he admits his work is “experimental”.

Problems began with Katelaris at least as far back as 1986. The NSW Medical Board record that in this year he “self-administered morphine”. The 2006 NSW Medical Board Annual Report includes a compelling paragraph on page 24;

Andrew John Katelaris

In 1991 Andrew Katelaris was suspended for 12 months from the practice of medicine because of his opiate use. However on return to practice Mr Katelaris continued to indulge in use of restricted or illegal substances, including morphine, pethidine, cannabis and ketamine.

In December 2005 the Medical Tribunal found Mr Katelaris guilty of professional misconduct conduct and ordered his de-registration with no review period for three years. The Tribunal found Mr Katelaris had inappropriately prescribed schedule 8 narcotics, a schedule 4D drugs and cannabis to friends, family and to himself not in accordance with therapeutic standards. It was also alleged he breached his registration conditions. The Tribunal considered that the flagrant disregard by Mr Katelaris of the conditions on the his registration was conduct that portrayed indifference and an abuse of the privileges which accompany registration as a medical practitioner.

The full NSW Medical Tribunal Determination, December 15 2005 may be found here. Katelaris could not apply for re-registration for a period of three years. It is clear from reading this document that Katelaris struggled with his opioid addiction and this was compounded by surgery in March 1992 for a spinal disc lesion. His Schedule 8 authority was restored in August 1992 with restrictions that he could not take possession of Schedule 8 drugs, only prescribing for patients at the hospital where he worked. In October 1993 his authority was fully restored.

On 14 January 2002 the Pharmaceutical Services Branch of NSW Health Department received a report of an empty packet of ketamine at the home of Katelaris labelled with a name other than his. On 19 January 2002, Katelaris was admitted to a hospital Emergency Department. Records note he stated he had been self administering ketamine since September 2001. His struggle with addiction continued with appropriate restrictions being applied when necessary. Regrettably for him it has destroyed his medical career.

Nonetheless his problems with self medication are not the problem for Chase. The danger is his reckless use of cannabis on vulnerable patients combined with the conviction he is doing what is right and what is safe. With a history of obtaining opiates for “friends and family” it is clear his provision of cannabis could be dangerously reckless.

In 2009 he sought to “review an order that his name be removed from the register of Medical Practitioners”. You can read the full NSW Medical Tribunal determination here. It is noted that in addition to the 1986 use of morphine he used both morphine and cocaine in 1988. No conviction was recorded and he was placed on a good behaviour recognizance for two years. He again self-administered morphine and at his own request his right to prescribe Schedule 8 drugs was withdrawn.

It was 1989 when Katelaris initially sought for the prescribing restrictions to be lifted. Restrictions on Schedule 8 remained but the Medical Board, after interviewing Katelaris decided some restrictions could be lifted. This depended on undergoing urinalysis and informing his employer “of the undertakings”. Katelaris refused thus the application was unsuccessful. The determination continues on describing his addiction to and use of morphine, Pethidine, Ketamine, cocaine and Fortral.

The Goat in the Sheep’s paddock

In describing his poor insight Katelaris said;

Poor insight, really that I was prepared to stand outside of a majority opinion. I must admit I considered myself very much…like a goat in a sheep’s paddock where a lot of people were content to walk one way but I felt free and quite unconstrained to exercise my own independence of thought and action. I still in many ways feel it is the right of every sovereign being to exercise independence of thought and action but being part of a profession which has considerable responsibility and access to technologies and pharmaceuticals of considerable strength and power, they have to be constrained so whilst maintaining an independence of thought I now accept that one does have to, to a greater or lesser degree, fall in with the herd, certainly in regard to accepted behaviour such as self- administration I have very little problem with saying that without equivocation.

He went on to say he was “testing the law” and was “impatient to bring forward progress in Australia”. When it came to not being able to supply cannabis to others in pain he added;

…but the insight was that I failed to appreciate the authoritarian stance and lack of compassion in the legal system

The application was dismissed and the applicant had to pay the respondent’s costs. The April 2010 NSW Medical Board News included on page 8;

Application for restoration to Register – irregular prescribing, own use of cannabis and breach of conditions

Issue

Mr Andrew Katelaris (MBBS (Syd) 1982) was deregistered in 2005 by the Medical Tribunal which set a non-review period of 3 years following a finding of professional misconduct for irregular prescribing of Schedule 8 and 4D drugs to family and friends, his own use of cannabis and breach of conditions on his registration. In his application for restoration, Dr Katelaris argued that he had developed insight and was a changed man.

Findings

The 2009 Tribunal did not accept that Mr Katelaris was a changed man, referring to his conviction for 4 criminal offences since 2005 and his inability to accept the 2005 decision; the application was dismissed.

As we can see today with respect to reckless administration of cannabis Katelaris remains very much a goat in a sheep’s paddock, unable to accept his responsibility to evidence based science. Despite his penchant for obtaining opioids for “friends and family” it is Katelaris’ reckless pseudoscientific use of cannabis that has raised complaints relating to the Drug Misuse and Traffiking Act 1985. Katelaris admitted his supply of cannabis for individuals between October 2002 and September 2004 was in contravention of the Act.

It was reported today that Katelaris was arrested yesterday and will;

…appear in court today charged with possession and supply of illegal drugs and also having cash suspected of being from the proceeds of crime. Police raided the St Ives home of Andrew Katelaris yesterday morning where they allegedly seized cash and cannabis found in the Luton Place resident of the former doctor. The 62-year-old was taken to Hornsby Police Station and charged and spent the night in the cells after being refused bail. As a doctor Mr Katelaris was an outspoken supporter of the use of cannabis oil for cancer sufferers.

Although it is almost certain that Chase’s condition is not a “vaccine injury” his parents have been convinced not only of this, but that he will die if fed and medicated properly by qualified medical staff. Under the “care” of Katelaris and others he has lost 50% of his body weight and is notably emaciated [See below].

Tragically last month his parents fled with Chase to prevent him being admitted to hospital for proper care, sparking an amber alert across QLD and NSW. In disturbing insight into how the rights of Chase are unappreciated by his mother, Cini Walker she posted a video at the time asking;

“My son is … Do I even own him anymore? Who’s going to help our family? When is this nightmare going to stop?”

Ownership of another human being? Whilst it is likely incorrect to suggest Cini thinks she owns Chase as she might a piece of property, it does yield significant insight into how incapable she is of accepting the role of Child Services, the necessity of medical care and the harm caused in snatching him from hospital to flee across state lines.

They stayed at the NSW Church of Ubuntu [Facebook] until FACS authorities under the protection of police came and removed Chase due to “medical neglect”. Indeed his life had become a perverse sideshow for a number of self-serving anti-science conspiracy theorists. The so-called church was raided on December 1st last year.

Presently Chase is safe in hospital for at least another week, despite the abuse and harassment of hospital staff by his “supporters”.

Unfortunately regardless of where he is or whom he is with Chase will continue to be used as a proxy for the antivaccinationist conspiracy theorists. A poster boy for the proposed magic of cannabis.

His parents are blind to the abuse and suffering they have allowed to be forced upon him. They have been manipulated into believing Chase must not be treated by reliable medical means and are blind to the towering immorality of what they have allowed; ongoing, sustained and life threatening medical neglect.

Only the strictest of conditions and ongoing monitoring will suffice when he is released into his mother’s “care”.

Chase before (left) and after his parents ceased prescribed nutrition

  • Updates added to text on June 1st 2017

‘Vaxxed’ Debunked – a selection of references

There is absolutely no doubt that the fraudumentary “Vaxxed: From Cover-up to Catastrophe” is demonstrably bogus nonsense.

It is also potentially very harmful nonsense and as such deserves to be debunked when the opportunity arises. There are a huge number of references that outline just why, and indeed how, this intellectual revulsion is firmly discredited by evidence. More so, there are a range of approaches presented in various critiques. This isn’t a result of authors seeking to be creative. Rather the final product of Vaxxed is so egregiously wrong on so many levels, it can be nudged into a pile of rubble from so many angles.

Interestingly the argument can be made that the main claim put forward in Vaxxed helped in destroying any attempt at credibility. The story of a so-called CDC whistleblower was easily revealed as bogus. The companion claim, that suppressed data showing a 340% increased risk of autism among specific populations of African-American boys resonated only in the echo chambers of antivaccinationists. Particularly when in the only official statement [2] from the “whistleblower”, we read irrefutable support for vaccination;

I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits. (William Thompson)

I trust these references are helpful.

1) This article from Snopes covers various sources of disinformation that sustain the primary lies in Vaxxed. Using articles that address the fallacious claims of Brian Hooker from an evidence based background and a range of other sources Snopes offers a compelling rebuttal.

Fraud at the CDC uncovered?

Rumour: Data suppressed by the CDC proved that the MMR vaccine produces a 340% increased risk of autism in African-American boys.

2) Did a high ranking whistleblower really reveal that the CDC covered up proof that vaccines cause autism in African-American boys? David Gorski; Science Based Medicine, August 25th 2014 [Source]

3) Autism, Atlanta, MMR: serious questions and also how Brian Hooker and Andrew Wakefield are causing damage to the autism communities Matt Carey; Left Brain Right Brain, August 26th 2014 [Source]

4) Hey, where is everybody? The “CDC whistleblower” manufactroversy continues apace Orac; Respectful Insolence, August 26th 2014 [Source]

5) Journal takes down autism-vaccine paper pending investigation Adam Marcus; Retraction Watch, August 27th 2014 [Source]

An article purporting to find that black children are at substantially increased risk for autism after early exposure to the measles-mumps-rubella vaccine has been shelved.

Although we don’t know if the events are related, the move comes amid claims that a CDC whistleblower has accused health officials of suppressing information about the link.

Not surprisingly, the prospect that the CDC has been sitting on evidence of an autism-vaccine connection for more than a decade has inflamed the community of activists wrongly convinced that such a link exists.

The paper, “Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data,” was written by Brian Hooker, an engineer-turned-biologist and an active member of that community. It was submitted in April, accepted on August 5, and published on August 8.

Translational Neurodegeneration, which published the article earlier this month, has now removed it and posted the following notice:

This article has been removed from the public domain because of serious concerns about the validity of its conclusions. The journal and publisher believe that its continued availability may not be in the public interest. Definitive editorial action will be pending further investigation.

6) Retraction Note: Measles-mumps-rubella vaccination timing and autism among young African American boys; a reanalysis of CDC data [Source]

7) CDC Whistleblower William Thompson Breaks Silence Todd W; Harpocrates Speaks, August 28th 2014 [Source]

8) The “CDC whistleblower saga”: Updates, backlash, and (I hope) a wrap-up David Gorski; Science Based Medicine, September 1st 2014 [Source]

9) MMR, the CDC and Brian Hooker: A Guide for Parents and the Media Todd W; Harpocrates Speaks, September 8th 2014 [Source]

10) Kevin Barry, you magnificent bastard, I read your antivaccine book! Orac; Respectful Insolence, August 25th 2015 [Source]

11) Reviewing Andrew Wakefield’s VAXXED: Antivaccine propaganda at its most pernicious David Gorski; Science Based Medicine, July 11th 2016 [Source]

12) Andrew Wakefield releases the trailer for his William Thompson video. Slick production and dishonesty Matt Carey; Left Brain Right Brain, March 22nd 2016 [Source]

I can’t recommend this article highly enough. In just a few paragraphs readers can see how Thompson was exploited by Hooker and Wakefield. We have this claim from the Vaxxed fiction;

“There’s a whistleblower from the CDC who is going to come out and say that the CDC had committed fraud on the MMR study and that they knew that vaccines were actually causing autism.”

Also we find when the genuine chronology of the Hooker/Thompson discourse is applied that Thompson is not a so-called “CDC whistleblower”. The manner in which Wakefield spliced unrelated conversations together to produce his fallacious narrative becomes clear. As Matt Carey writes (emphasis mine);

Well, Thompson never says in his statement that there was fraud or misconduct by the CDC team. He does say “Reasonable scientists can and do differ in their interpretation of information.”

Let’s back up a bit, what is the Hooker/Wakefield claim of fraud? In a nutshell, they claim that the CDC team found a result they didn’t want to make public and then changed the research plan/protocol so they wouldn’t have to report that. In this exchange from a phone call we can see Hooker apparently trying to get Thompson on tape saying this. Trying because Thompson refuses to say it:

Dr. Hooker: And then you basically deviated from that particular plan in order to reduce the statistical significance that you saw in the African American Cohort.

Dr. Thompson: Well, we, um, we didn’t report findings that, um…All I will say is we didn’t report those findings. I can tell you what the other coauthors will say.

As to the claim by the narrator that Thompson stepped forward and stated… “that [The CDC] knew that vaccines were actually causing autism”. Nope.

[…]

Also, Thompson provided a summary statement to Member of Congress Bill Posey. That was made public along with a great deal more documents when I released them here. What does Mr. Thompson have to say about the study in question showing that vaccines “actually cause autism”?

The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation.

It’s clear that Thompson struggled at times with mental illness. He was deeply concerned that it would become public knowledge. Wakefield’s callous disregard is on display again as we read:

The only reason people know about Thompson’s personal medical history is that Brian Hooker and Andrew Wakefield made it public. Hooker and Wakefield filed a complaint with the Department of Health and Human Services and included this statement from William Thompson:

Ya know, I’m not proud of that and uh, it’s probably the lowest point in my career that I went along with that paper and I also paid a huge price for it because I became delusional.

13) Seven things about vaccines and autism that the movie Vaxxed won’t tell you Ariana Eunjung Cha; May 25th 2016 [Source]

14) Vaxxed – a guide to Andrew Wakefield’s fraudulent film The Original Skeptical Raptor; December 22nd 2016 [Source]

15) The William Thompson Documents – There’s no whistle to blow Matt Carey; Left Brain Right Brain, January 6th 2017 [Source]

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