COVID-19: Who fact-checks the fact-checkers?

New Zealand physician: 'Evidence available reveals we have no idea how many false positives will be when PCR testing is used in community.'

Mordechai Sones ,

New Zealand coronavirus
New Zealand coronavirus
iStock

Joining a growing international body of physicians, scientists, journalists, and even some statesmen who have expressed skepticism regarding official COVID-19 information and policy, Dr. Sam Bailey MD of New Zealand says: "We have no idea of the magnitude of how much the PCR tests don't work in the real world."

A video she produced a month ago entitled Why Are Covid-19 Cases Soaring In NZ? PCR Test Update earned a "fact check" critique. In this new video, Dr. Bailey seeks to rebut the claims made by the "fact checkers".

"When I heard that my PCR video had been 'fact-checked', and that my video came with a 'partly false' information warning on Facebook, I felt like I was being silenced.

"As the journalists didn't ask me what my response was, I felt it was only fair to make a video on my channel specifically addressing the fact-checking related to COVID-19 PCR tests."

After noting that all references are included in the video's description, Dr. Bailey continues: "Firstly, the article has been written as more of an opinion piece by AFP's political reporter Taylor Thompson-Fuller, and I can only take the quotes from the three experts at face value."

The article she refers to is titled: New Zealand doctor makes misleading claims about the country’s PCR testing regime in widely shared YouTube video.

Dr. Bailey continues: "I'd be more than happy to have a discussion with any of them, and they are more than welcome to reach out to me.

"Despite the article supposedly being about my PCR video, it links my video to the Advance New Zealand Party and its leader, who they say has made previous misleading claims. In case it needs clarification, I am apolitical, with no links to any political party.

"I wanted to investigate who the three experts were that fact-checked me. The first is John Mackay, who owns a company called DNature that received New Zealand government funding to help develop a test to diagnose COVID-19. He's also supplied the Institute of Environmental Science and Research with viral kits.

"The second is Thomas Lumley, who is a professor of biostatistics at the University of Auckland in New Zealand. Disappointingly, the fact-checked article didn't seem to get any statistical analysis from him, so it's unclear why he was interviewed.

"Thirdly, there is microbiologist Professor David Murdoch, from Otago University, who has played a leading role in a Bill and Melinda Gates Foundation-funded global study of childhood pneumonia. He's also been a key advisor to the New Zealand government during the COVID-19 pandemic, and one of three independent international experts selected to advise the Oxford University team developing a vaccine for COVID-19.

"In my video, I point out that the PCR test doesn't test for the virus, and I stand by this claim. Thomas Lumley states that the test looks for RNA sequenses that are present in the COVID-19 virus, which are not present in other viruses known to infect humans.

"It may be true that the RNA sequence is present in the COVID-19 virus, but by no means establishes that COVID-19 would be the only reason why the particular RNA sequence could be present in a living organism. For example, we have no idea how many viruses and other microorganisms we have in or on our bodies that are not yet sequenced, resulting in unknown specificity of the test on face-value alone.

"John Mackay simply echoes Lumley, but also states that 'multiple independent PCR tests confirm the positive result is due to SARS-2-Cov'. You'll see in a minute that this may be true in controlled lab studies, but no claims can be established about using the test to diagnose COVID-19 in the community.

"The PCR test is, and always has been, an 'indirect test', aimed at detecting a small sequence of RNA. Because the amount of RNA is so minuscule, the test requires exponential amplification, and it's even more complicated when the RNA comes from living tissue, where we are uncertain of potential contaminants. Any contamination, such as other viruses, or debris from old virus genomes, can possibly result in false positives. It does not test for the full genome of an entity such as a virus, and it's a big leap to conclude that a positive PCR test in a living human is always from one specific virus.

"Where is the evidence? Can Lumley or Mackay list any studies that show a positive PCR test is reliably correlated with formal isolation of the virus, as well as a standardized COVID-19 clinical diagnosis?"

Dr. Bailey continues: "Murdoch is apparently unfazed by the lack of a gold standard with regards to diagnosing COVID-19. He makes a curious statement: 'How do you know how good it is when it's the best one.' This would imply that you don't need to worry about scientific parameters such as sensitivity and specificity in a population setting, you simply use whatever test you've got. It seems that the test validates itself, therefore the test validates itself.

"Murdoch goes on to compare COVID-19 PCR testing with breast cancer screening, to imply that a PCR test can be used for both screening and diagnosis. I find this to be an inappropriate comparison, because with breast cancer we have decades of data involving millions of people, comparative trials and established gold standards. That is simply not the case with COVID-19.

"Lumley states that the COVID-19 PCR test is 'an excellent screening test', but there is no reference to any studies involving patients that would back up this claim. Is Lumley making this claim based on a laboratory study?

"One study is linked from the New Zealand Ministry of Health COVID-19 test results and their accuracy web page. But, wait a minute - these are in-vitro lab studies, not real clinical studies involving patients.

"The laboratory tests assess the accuracy against 'cultured viral stocks from a single clinical isolate', and I'm not saying that the methodology is incorrect, but it is in a controlled lab setting with purified samples, and in no way establishes the accuracy of the PCR test and real patients in the community.

"To give credit, the Ministry of Health web page states: 'It is important to remember that tests don't work as well in the real world.'

"But this is such a crucial point, with the COVID PCR test. We have no idea of the magnitude of how much they don't work in the real world. I've seen people claiming that the COVID-19 PCR test has 95% specificity. Yes, a test kit correctly detects COVID-19 in purified lab samples 95% of the time. They don't seem to realize that the specificity in diagnosing COVID-19 in new community cases is completely unknown.

"In fact, the manufacturers of the PCR test kits usually have some sort of disclaimer about what the test is suitable for. An example here is the RealStar PCR kit from Altona Diagnostics, clearly stating: 'For research use only!'

"There are other videos on YouTube showing antibody test kit disclaimers that read: 'Not FDA approved', and that the test results may be positive due to non-COVID-19 coronavirus strains.

"Have any other authorities realized that there are problems with testing for COVID-19? On September 15th, the Australian government Department of Health released the following statement: 'The reliability of COVID-19 tests is uncertain due to the limited evidence base.'

"Lumley goes on to state that 'the antibody test is more reliable in people who have been symptomatic for several days.' The antibody test is another indirect test of viral presence, but in this case of apparent past exposure. No study is referenced for us to assess the reliability of antibody testing and how it should be applied at a population level.

"The Ministry of Health had a fact-sheet that talks about COVID-19 antibody testing. But it is unreferenced, generic in nature, and makes no statement about test reliability.

"Again, the Australian government has recently made comments on antibody testing: 'There is a window period between virus infection and the production of IgM and IgG antibodies, and the sensitivity and specificity of of IgM/IgG antibody tests early in SARS-CoV-2 infection is not well characterized.'

"And perhaps the most damning statement about the current state of testing: '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.'

"So why did I talk about the new surge in cases in New Zealand? The evidence available reveals that we have no idea about how many false positives there will be when PCR testing is used in the community. At this stage, the clinical utility of the test is unknown. If you widely test, there will be positive results. So how do we interpret these?

"At the end of the day, I feel that many of the experts are making overreaching claims about COVID testing that are simply not backed up by medical evidence. The onus is on them to provide this evidence, rather than criticize and attempt to silence those of us who remain skeptical, and want to engage in open debate."

This report examines these questions in addition to reviewing video clips of multiple doctors weighing in on the subject including the biochemist Kary Mullis who invented PCR and won a Nobel Peace Prize for doing so:



top