30th October 2020
Complaint by Danielle Burnie to the TGA of Australia re PCR tests
The author has agreed for her name to be published. In which case I’m also publishing the PDF here.
Professor John Skerritt
Therapeutic Goods Association
PO Box 100
Woden ACT 2606
CC: Australian Department of Health; Office of Health Protection; The Public Health Laboratory Network; The Advisory Committee on Medicines; Australian Medical Association; Political bodies; media outlets; Australia Federal Police; Victoria Police; The Department of the Prime Minister and Cabinet; Parliament of Australia; Australian Human Rights Commission; My Aged Care.
FORMAL COMPLAINT – PCR TESTING AUSTRALIA
Dear Mr Skerritt,
I am writing to make an official complaint about the medical device and subsequent testing process for the detection of SARS-CoV-2 in Australia.
The PCR tests being used in Australia were expediated due to the ‘pandemic’ nature of Covid-19. This means they have been approved based on very limited clinical and performance data.
It is well and truly overdue that the PCR testing be properly and thoroughly evaluated.
Before this occurs, I urge you to call an immediate cessation to the use of these testing devices in Australia.
These tests are being used by the government to justify measures protecting against a pandemic. The pandemic was declared by the WHO and it should be noted that the WHO changed the definition of a ‘pandemic’ 12 years ago, a pandemic was originally defined as a disease that spread worldwide resulting in widespread serious illness and death. Now it merely requires that a disease spread worldwide. If we, in Australia accept this definition, it makes it very easy to declare a pandemic when a screening tool like PCR tests are used as diagnostic tools. The number of deaths and ‘cases’ in Australia does not merit the declaration of a pandemic here, especially when these numbers are based on PCR testing.
The Government is using these tests results not only in Australia but the rest of the world, where PCR is also being used, to justify the following (not limited to):
- Passing laws to give unprecedented authority to civilians (Omnibus).
- Passing federal laws to enable foreign troops and foreign police forces to enter Australia in the event of an emergency, immune from prosecution. (Defence Legislation Amendment (Enhancement of Defence Force Response to Emergencies) Bill 2020.
- Violating privacy by the proposed use of telephone GPS for contact tracing.
- Border closures
- 200+ days and counting of severe restrictions on the state of Victoria including:
- Limits on numbers of visitors in households
- Limits on numbers of contacts outside the home
- Shutting down of schools
- Businesses closed
- 5km radius restriction from homes
- Denied access of visitors to retirement homes
- Isolation of ‘suspected’ or ‘confirmed’ cases
- Mandatory wearing of masks in public
- Mandatory wearing of masks by children in school
- Limit of 1 hour exercise per day
- A nightly curfew between 8pm – 5am
- Social distancing.
A vaccination campaign has already begun with policies such as no jab, no pay. No jab, no travel. This is a serious and provocative threat by the government and once again justified in their opinion by ‘case’ numbers.
The physiological and psychological consequences of these policies will have devastating and uncountable consequences on the lives of all Australians. The deaths and permanent injuries caused will outnumber by thousands any death or permanent injury caused by Covid-19.
The weight that is being placed on the statistics is monumental. And the statistics are all being derived from PCR testing.
You have a responsibility to investigate this medical fraud, I do not use that term lightly. But there is enough evidence for me to be extremely concerned that this is exactly that, medical fraud.
Please see below the information I have gathered about PCR testing.
1. The TGA’s own ‘information for health professionals’ page says there is limited evidence available to assess the accuracy and clinical utility of available Covid-19 tests. AND ‘Covid-19 is an emerging viral infectious disease. There is limited evidence available to assess the accuracy and clinical utility of available Covid-19 tests’.
2. PCR TESTING DOES NOT DISTINGUISH BETWEEN COVID-19 AND INFLUENZA
The Covid-19 virus has never been isolated. Each and every positive test is an ‘assumption’ that the test is picking up the SARS-CoV-2 virus. As confirmed by the CDC1.
‘The analytical sensitivity of the rRT-PCR assays contained in the CDC 2019 Novel Coronavirus (2019- nCoV) Real-Time RT-PCR Diagnostic Panel were determined in Limit of Detection studies. Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/µL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen’.
In the user guide of one test available in Australia, it clearly states the PCR test does not distinguish between SARS-CoV-2, influenza, RSV A and B types. The guide goes on to say that a positive result should be evaluated by a health care professional in the context of medical history, symptoms and other tests2.
In September 2020, Roche Pharmaceuticals developed a unique PCR test that distinguishes between the flu and Covid-19. This has received emergency authorisation in the US3. This clearly shows that before this date no tests were able to distinguish between Covid-19 and the flu.
3. THE SARS-CoV-2 VIRUS HAS NEVER BEEN ISOLATED
A FOI request to Public Health England revealed that the virus has not been isolated4. The FOI response can be found in the references.
Public Health England also confirmed that detecting viral material by PCR does not indicate that the virus is fully intact nor infectious5.
Dr Andrew Kaufman criticised a paper published in Nature which claims to prove the pathogenicity of Covid-19. Dr Kaufman disproved the study showing that SARS-CoV-2 does not meet Koch’s 4 postulates for germ theory. Koch’s postulates are the basic principles that must be met before a virus can be proved to cause disease6.
This is collaborated in another article showing that SARS-CoV-2 fails to meet even one of Koch’s postulates let alone them all7. This is a vital point that has been deliberately ignored by governments worldwide.
PCR tests are calibrated to match a specific RNA, but we do not know that the RNA is specifically from the SARS-CoV-2 virus because it has never been correctly isolated or purified. So, to which RNA are the PCR tests showing positive?
In an article titled ‘PCR Covid-19 Test are Scientifically Meaningless’, study authors of all relevant papers (‘proving the existence of SARS-CoV-2) were contacted and they all confirmed that the shots depicted in their experiments did not show purified viruses8.
4. FALSE POSITIVES
PCR tests have a false positive rate of around 0.8%. Dr Yeadon, former Chief Science Officer for Pfizer states ‘The likelihood of an apparently positive case being a false positive is between 89 to 94 percent or near certainty’9.
According to Dr Malcolm Kendrick10, the negative percentage agreement (NPA) of most commercially available tests is 95.6%. If we look at a practical example using the UK figures (since Australia’s ‘cases’ are so low), it would look like this: From 350,001 tests, 2, 948 were positive. Using the NPA we get the following figures:
0.956 = TN / 350,100
Therefore, the number of true negatives is:
TN = 350,100 * 0.956 = 334696
Therefore, the number of false positives we would expect from 350,100 tests is: FP = 350,100 – 334,696 = 15,404
This is more than five times the number of positive tests reported, which means we cannot have any confidence that any one of those positive tests represents a genuine case. When you apply this to the Australian cases, the numbers are so drastically low that it is statistically impossible for any of them to be true positives. The question is ‘where are all the false positives’?
Contributing to the evidence of false positives, a study called ‘Diagnosing SARS-CoV-2 infection: the danger of over-reliance on positive test results’ found the following: ‘The high specificities (usually 100%) reported in PCR-based tests for SARS-CoV-2 infection do not represent the real-world use of these tests, where contamination and human error produce significant rates of false positives. Widespread lack of awareness of the real-world false positive rates affects an array of clinical, case management and health policy decisions. Similarly, health authorities’ guidance on interpreting test results is often wrong. Steps should be taken immediately to reduce the frequency and impacts of false positive results, including checking positive results with additional tests at least when prevalence is low11’.
Another study, ‘An optimisation of four SARS-CoV-2 qRT-PCR assays in a Kenyan laboratory to support the national COVID-19 rapid response teams’, found the following: ‘We highlight the challenges encountered in the use of the BGI kit that we noted was prone to false positives, but this was mitigated by diluting the reagent volumes and by including an additional confirmatory assay12.
It should be noted that Victoria is using the BGI kits.
A study on the potential false positive rates of asymptomatic patients found that ‘In the close contacts of COVID-19 patients, nearly half or even more of the ‘asymptomatic infected individuals’ reported in the active nucleic acid test screening might be false positives,’ the false-positive rate of positive results was 80.33%’13.
Dr Reiner Fuellmich14 from the German Corona Investigative Committee explains that the developer of the Covid-19 PCR test, Professor Drosten used an old SARS virus to create the PCR test which returned a positive from Covid-19 victims in China. This very inaccurate beginning was enough for the WHO to declare a pandemic and authorise worldwide use of PCR testing. They have never validated Drosten’s test. Drosten himself said in 2014 that PCR testing was so highly sensitive that even very healthy and non-infectious people may test positive.
This test cannot detect infection. An infection is when a virus penetrates cells and causes symptoms and only then is a person contagious. Until then, it is completely harmless.
Alarmingly, in 2007 PCR tests were responsible for the incorrect belief that whooping cough was spreading through a hospital in New Hampshire, US. This mistake had serious ramifications. Thousands were given antibiotics and vaccines. 8 months later the victims received an email saying the tests were incorrect due to their over sensitivity15. There is a very high chance this is happening around the world now, especially in Australia given the extremely low case numbers. However, the ramifications here, are even more serious than just antibiotics and vaccines (although this is also incredibly concerning).
5. All tests have a margin of error, this is not being taken into account by the Victorian Government, or any of the State jurisdictions. If the margin of error was applied (2 – 3%) there would be ZERO Covid-19 cases or deaths in Australia.
6. The Department of Health and Human Services confirmed that Victoria uses a CT of 35 – 40. This is a deliberate and malicious misuse of this screening tool. According to Professor Raoult from France, any sample amplified above 35 is not viable for analysis. 97% of positive tests at a cycle above 35 are diluted so much they are no longer viable for testing.
Up to 35CT there are still living virus cells, anything from 35CT, there are only dead virus cells. Using such a high amplification dilutes the sample to practically water and leaves debris of dead virus cells that are detected16.
Any positive result in this case does not indicate that a person is sick or infectious and yet these positive results are declared a ‘case’. The sample should not be amplified over 30CT. Even with 30CT, the sample is amplified by 1,000,000,000 (one billion), with the temperature changes that occur during the process the sample is very compromised. Dr Raoult recommends a CT of 25.
On top of this, the definition of a ‘case’ should never be someone who tests positive. A case must be determined based on other evidence such as the person exhibiting related symptoms and a second confirmed test.
Using a CT value higher than 40 goes against the MIQE guidelines. ‘A CT value higher than 40 is extremely suspect because of the implied low efficiency and generally should not be reported’ ‘Minimum Information for Publication of Quantitative Real Time PCR Experiments’17.
A person can shed RNA for 3 months, so the immune system has already killed the virus but tiny debris can be left which is picked up in a PCR test sample amplified above 35. This can also account for ‘mysterious’ cases where a person tests positive again weeks or months after their initial positive test.
A false positive result that is being treated as a ‘case’ goes against the Hippocratic Oath as all sorts of treatments and restrictions are imposed on a person. Any Doctor who makes treatment decisions or support government restrictions based on a positive PCR test should be investigated for violating the Declaration of Geneva. This includes the inhumane isolation of our elderly and restricting their access to loved ones.
7. False positives are causing harm and unnecessary suffering to Australians. Two of Australia’s youngest Covid-19 ‘victims’ were found at autopsy to not be positive to Covid-19. Their false positive tests were declared as cases by the Government and by the media instilling fear in the public and helping to justify the government response. This is immoral and unethical. No positive test should be declared a ‘case’ until it is proven with accompanying symptoms and a second positive test 18,19.
A nurse was vilified for traveling to an area of Qld where one of the young victims, Nathan Turner was supposedly infected20. Blaming an innocent person for the death of a young man is disgraceful behaviour of which the government and media should issue an apology, this was never done.
8. Payments are being made to retirement homes, testing facilities and to individuals for Covid-19 testing. This practice contributes to a great risk of fraud committed for the purpose of receiving extra money. This is highly unethical. We have heard reports of Covid-19 being added to death certificates in aged care so that the victim’s family and the residence benefit financially. There are also allegations that Doctors receive money for attributing deaths to Covid-19 on death certificates. As Covid-19 death is not ‘reportable’, victims are not autopsied which means there is absolutely zero proof that anyone has died from Covid-19. In fact, 2 of the victims that were autopsied, were found to not have Covid-19 at all.
Julia Morgan from Glenferrie Private Hospital confirmed that the cause of death of four patients was unable to be confirmed but the State went ahead and declared their deaths due to Covid-1921. This is outrageous.
9. It is extremely concerning that there is no independent body to assess the use of PCR tests for detecting Covid-19. The Doherty institute who performed the post market validation of the BGI test are the same scientists who are developing vaccines for Covid-19 as well as other research. They also received a $2 million donation from social networking platform, TikTok for Covid-19 related research22. This is a major conflict of interest and it is a great matter of public safety that an independent body be engaged to complete a thorough evaluation of all PCR testing and analysis processes.
10. Community testing is getting out of control with the test being abused. Asymptomatic people are being tested and the test is not intended to be used this way, this is fuelled by financial incentives. $450 is offered for a test and $1500 for a positive test, subject to conditions. Premier Dan Andrews threatens citizens that restrictions will not be lifted if testing levels drop23. He is also ramping up workplace testing24.
11. The nasal swab to retrieve a sample is not without its risks. There has been one report of a woman whose brain lining was punctured leaking fluid and requiring surgery25. A 1 and a half-year-old died in Saudi Arabia after the swab got stuck in his nasal passage26. Dr Stuckelberger from Switzerland reported concerns that it is an extremely sensitive area with a very high possibility that nanoparticles can be transferred from the swab into the brain27.
12. Dr David Rasnick has expressed concerns that the DNA when a swab is taken is being stored in government databases. Patients are not informed of this when they are tested and they do not give their consent for their DNA to be stored. There is no guarantee that this DNA will not be used or passed on or sold to another body. This is an illegal breach of privacy and trust. Patients must be assured that none of their information taken from a PCR test will be stored or used by third parties.
13. A very serious issue has emerged from Geneva where Doctor Edouard Broussalian sent unused PCR tests to a lab, they all came back with a positive result28. Dr Sherri Tenpenny also stated that PCR tests had been receive that were already infected, in many Countries including Slovakia and Germany. Using these on innocent people could have untold consequences, either infecting them or delivering a positive test result29.
14. Governments are undertaking testing in sewerage, if this type of random and unscientific measures continue, the virus will never go away, PCR testing will keep giving positive results if the amplification is high enough.
15. Autopsies are not being carried out on Covid-19 victims. This is extremely suspicious. All suspected Covid-19 deaths should be reportable and investigated by the coroner. As already stated, 2 victims that were autopsied were not positive to Covid-19, demanding autopsies on all victims could bring many answers to the people of Australia.
PCR tests results have been used by the government to justify implementation of strict and drastic measures that have negatively impacted on people’s lives and resulted in many deaths. The results have been a violation of human rights by removing freedom, destroying businesses, isolating and torturing our elderly, causing a major mental health crisis, causing great suffering to children and families, greater poverty, increased suicides and other unnecessary deaths. The people of Australia are suffering PTSD as a direct result of Government measures.
This is a clear act of misfeasance. This practice needs to be ceased immediately and I urge you to recall all PCR testing equipment and demand that any government measures that were applied based on these test statistics be immediately ceased. A proper evaluation needs to be conducted and a thorough investigation must be launched into the misconduct by the government in relation to PCR testing.
In the event of inaction by the TGA, I will be seeking legal advice to pursue private criminal prosecution under common law.