Doctor Paul Jackson
Mississauga Ontario
2 January 2021
Premier Doug Ford
Queen’s Park, Ontario
Doctor Dave Williams
Chief Medical Officer, Ontario
Dear sirs,
I am writing this open letter to you, the premier and the chief medical officer of Ontario – the officials most responsible for our province’s response to the presence of SARS-CoV-2 – concerned that you may have been misinformed and ill-advised regarding the danger that this coronavirus poses to Ontarians. The consequences of the ensuing misunderstanding are already proving to be catastrophic to the lives of those you have sworn to serve. In what follows, I will present official data and analyses that will lead us to the inevitable conclusion that the testing protocols currently in use are misguided and a threat to public health, to the natural rights of Ontarians, and to the future prosperity of the province. I do not take my status as citizen lightly. I assume that you are no less mindful of your responsibilities as policy makers. As politicians and public servants, you are obliged either to justify your actions by cogently answering the questions that arise throughout this exegesis or to change course.
This letter specifically questions diagnostic protocols as well as the value of PCR assays, often erroneously referred to as PCR “tests.” The province has embarked on an unprecedented and extensive campaign of PCR “testing” for SARS-CoV-2 among the population. Why?
Did a new and deadly virus pose a threat to Ontarians at large in 2020? Alternatively, was the threat confined to only a segment of the population? What evidence exists that such a virus continues to warrant population-wide testing? In this section, we will review data from Statistics Canada (StatsCan) and Public Health Ontario to determine what case could be made for public resources to be channelled into an extensive and costly testing regime.
According to Statistics Canada, from January to October in 2018, there was a total of 228,058 deaths from all causes across the country; in 2019, there were 226,994 deaths for the same period. In 2020, that number was 241,257, which was 10,090 deaths higher than modellers at StatsCan had projected.
From the end of September 2020 to the end of October 2020, the total deaths from all causes in Canada was 22,741, which was 1,292 (1.06%) higher than projected. Two thirds of those excess deaths were in people over the age of sixty-four.
The statisticians at StatsCan conclude that excess deaths from March to June correspond closely to the deaths attributed to COVID-19. Then, throughout the summer months, weekly deaths returned to normal, tracking closely to the historical trends. However, excess mortality began to rise again when autumn began. In each case, the excess deaths are among people over age sixty-four.
We need to consider one important anomaly, extracted from StatsCan data. From the middle of May to the middle of October, 1,385 more deaths than anticipated, based on historical trends, occurred in Canadians under forty-five years of age. Males accounted for eighty-one percent of those excess deaths. However, for all of Canada during that period, less than fifty deaths in that age group had been attributed to COVID-19. The analysts at Statistics Canada argue that “increases in mortality could also be due to indirect consequences related to measures put in place to address the pandemic, such as missed or delayed medical intervention and other possible changes in behaviours such as increased substance use. For example, in British Columbia, the Chief Coroner’s Office has reported increases in deaths due to overdoses since the start of the pandemic.”
Among the cohort of the population under forty-five, then, the excess deaths resulting from the lockdown measures could reasonably be twenty-eight times greater than mortality from COVID-19. Does the government of Ontario reject the findings of Statistics Canada? The deadly lockdown measures have been justified on the basis of the alleged number of “cases” as determined by PCR “tests.” What is the actual risk of COVID-19 in the context of all-cause-mortality in Ontario? Importantly, what is the risk to the cohort of the population upon which the lockdown measures are having the greatest impact?
In Ontario, 4,277 deaths have been attributed to COVID-19 as of 27 December 2020. Of those, 3,809 have been in people over the age of seventy. Of those deaths, 2,578 have occurred in long-term care homes. Out of a population of fourteen and a half million people, only fifty-four COVID-19 deaths have been recorded among people under the age of fifty.
It would be ludicrous for the government of Ontario to claim that the lockdowns are necessary because fifty-four people under the age of fifty had died of COVID-19 throughout the entire year. According to the government of Ontario, flu causes 3,500 deaths in Canada each year. We have always accepted our relationship with the viruses and bacteria that surround us and inhabit us as a part of being human, of being a multicellular animal. Now, the government of Ontario is constructing a complex, comprehensive infrastructure of testing, of tracking and tracing, of vaccination, and of shutting down the entire social and economic life of the province based on an entirely predictable mortality from a respiratory virus. How can a few dozen deaths justify this response, this overkill? Were it not for the conflation of positive PCR “test” results as new “cases” of COVID-19, it is difficult to imagine how the province could sustain its extreme and increasingly capricious restrictions.
As a consequence of PCR “test” numbers, the quadrants of the population least affected by the SARS-CoV-2 virus have been ordered to lock down, to social distance, to mask, to isolate themselves from all of society, and, in many cases, to forfeit their businesses and life savings. Those elements of the population are no more at risk from SARS-CoV-2 than they have been from any influenza virus that Ontarians have ever confronted. Meanwhile, those who are actually vulnerable to this virus – people over sixty-five-years old with co-morbidities and, especially, in long-term-care homes – are already locked down. They have been self-isolating out of necessity as they have reached the end of their lives. Each human life has an end date. As the scientists behind the Great Barrington Declaration have cogently argued, the only logical and compassionate response to SARS-CoV-2 is to protect as much as possible those who are at the greatest risk, almost exclusively the most aged and infirm – with access to anti-virals, vitamins, and good nutrition – and allow all others to live their lives as freely and openly as possible.
Have PCR assays misled health professionals in the past? What lessons can we learn from history before we proceed?
In April of 2006, at Dartmouth-Hitchcock Medical Center in New Hampshire, an internist came down with a cough that lasted for three weeks. When other healthcare workers began coughing, the infectious disease specialist at the hospital feared that she might be witnessing an outbreak of whooping cough, which could be fatal among babies as well as the frail and elderly. To confirm her suspicions, nearly 1,000 healthcare workers at the hospital underwent a PCR assay to search for the bacterium Bordetella pertussis. One hundred and forty-two tested positive. Consequently, thousands of people were given antibiotics and vaccinated against whooping cough as a precaution. The hospital reduced its bed capacity, including in the intensive care unit.
Epidemiologists working for New Hampshire and Vermont decided to confirm that the illness had actually been whooping cough. However, they were unable to culture Bordetella pertussis from the blood samples of any of those who had been sick. They then looked for antibodies in the blood of those presumed to have recovered from the whooping cough epidemic. They tested the blood of those who had not been vaccinated, since vaccines generate protective antibodies. In none of those diagnosed with whooping cough on the basis of the PCR “test” was there evidence of antibodies. In retrospect, they concluded that the sick had most likely suffered through a bout of the common cold. Eight months after the presumptive epidemic, all of the healthcare workers who had been diagnosed with whooping cough on the basis of the PCR assay were informed that they had not, in fact, contracted Bordetella pertussis.
The doctors at Dartmouth-Hitchcock had believed the PCR assays and responded in order to contain the spread of an infection, whooping cough. After all, a cough was a symptom of Bordetella pertussis infection. The patients all coughed. However, coughing is a symptom of many respiratory illnesses; only when a “scientific” test confirmed the fears of one doctor, a specialist in infectious disease, did the “epidemic” take flight.
Biochemist Kary Mullis invented the process of polymerase chain reaction, or PCR, for which he won the Nobel Prize in Chemistry in 1993. It is a method for finding very short segments of a sequence of nucleotides (such as twenty base pairs) and amplifying them exponentially until the researcher has enough to study the DNA in detail. It is a laboratory technique. DNA is composed of a sequence of nucleotides. If researchers know what sequence along a strand of DNA they are looking for, they can target it by using primers that bind to the two ends of that sequence. Then, they replicate the fragment between the two primers. One sequence is now two. With each amplification, through the technique of polymerase chain reaction, the sequence is doubled. So, one becomes two, two becomes four, and so on as long as the amplification process is carried out. After thirty-eight cycles, you have made 272 billion copies of the original one.
Mullis made it clear repeatedly until his death in 2019 that the PCR method could not be used as a diagnostic test. PCR is a laboratory tool, used to identify a string of nucleotides and make enough copies so that a researcher can work with them. PCR assays, insisted Mullis, could find anything that the researcher wanted to find, since every human is replete with fragments of molecules belonging to our own cells as well as the incalculable number of microbes that co-inhabit our bodies. I would add that scientists have not identified and sequenced all of the bacteria, viruses, and microbes, called the bionts, that live with us, in us, and on us, the host. Collectively, the bionts and the host (each individual human) are called the holobiont. The entirety of the genetic material of bionts and host is called the hologenome. We will never be able to map that hologenome definitively because it is a dynamic assemblage and it varies from human to human.
Coronaviruses, such as SARS-CoV-2, are RNA viruses and so need to be converted to DNA before the PCR assay can be applied. This requires a further step called reverse transcription. RNA viruses, such as coronaviruses, are especially resilient as a result of the ease with which they mutate, since they are a simpler, single strand of nucleic acids, as opposed to the double helix of DNA. By the time you can track any RNA virus with one test, its genetic code will already have mutated into a new iteration. That is why we catch colds every few years; the coronavirus has mutated to the point at which it can slip through our defences again. Why is Ontario so obsessed with last year’s cold virus as we enter 2021? Why is the province dedicating so many resources to test the population for signs of fragments of nucleotides from a cold virus that will mutate many times, as viruses have done since the dawn of time?
What qualifies as a “case” of COVID-19 in Ontario?
In Ontario, the definition of a COVID-19 case is exceptionally broad and imprecise. “Probable cases” include people experiencing any of the following symptoms: fever, cough, shortness of breath, sore throat, runny nose, decrease or loss of smell or taste, nausea, vomiting, diarrhea, or abdominal pain. Atypical, but still relevant symptoms include: chills, headache, conjunctivitis, fatigue, lethargy, malaise, muscle aches and pains, decreased appetite, worsening of chronic conditions, fast heart rate, low blood pressure, hypoxia, difficulty feeding in infants, acutely altered mental status, inattention, increased number of falls for the elderly, acute functional decline, and clinical or radiological evidence of pneumonia. A “probable case” is someone who is experiencing any of those symptoms and has travelled to or from an affected area in the fourteen days prior; or has come into close contact with a confirmed case; or lives or works in an environment known to be experiencing an outbreak. Since all of Ontario has now been declared an affected area, any of those symptoms are enough to diagnose a “case.”
Before we move on to consider how Ontario Health diagnoses “confirmed” cases of COVID-19, let’s consider the implications of the expansive definition of a probable case. Clearly, the symptoms of a probable case of COVID overlap with a number of other conditions, including the flu. If seasonal flu cases are being diagnosed as COVID, then we should see a reduction in the influenza numbers across the counttry. That is exactly what is happening.
In Canada, flu season normally begins around the middle of November. All provinces and territories closely monitor influenza activity, through the FluWatch program, and the federal government publishes the data, which are positive laboratory tests. This year, laboratories have performed more tests than usual. During week fifty, for example, they performed twice as many tests as usual. Despite that increased testing, the percentage of tests positive for influenza was 0.02%, compared to, on average, 16.8% over the last six years. To date, throughout the 2020-2021 flu season (since week thirty-five), only forty-seven cases of influenza have been detected. Twenty-seven of those cases were contracted from the live attenuated flu vaccine (LAIV), which leaves only twenty cases of community transmission. Over the last six seasons, an average of 4,354 influenza detections have been reported between weeks thirty-five to fifty, (from mid-October to mid-December). Note that those numbers do not represent the total cases in Canada, but, rather, detections among a sample of the population. They are a proxy for the prevalence of influenza.
Similarly, the World Health Organization, through the Global Influenza Surveillance and Response System, tracks the prevalence of all known strains of influenza virus throughout the world. Since the beginning of May 2020, no specimens of those eight viruses have been reported. At least in the official mortality data, SARS-CoV-2 has taken over the field. Is this a consequence of the virus itself? Alternatively, is it a result of the medical officers diagnosing all respiratory illnesses as COVID-19? In Ontario, given the government directive for diagnosing everybody with flu-like symptoms as COVID, influenza cases would predictably drop off the map. However, the fact that FluWatch is increasing its testing program and still not finding influenza cases suggests other factors may be at play.
An explanation for the disappearance of influenza worldwide may be found in the work of Hope-Simpson and Golubev, who published their findings in 1987; the sudden appearance of a new virus, causing a pandemic, displaces other influenza strains that normally infect the host seasonally. In their historical survey, they found that, after the first wave, the new virus only ever results in ripples where those still unaffected may become infected. We would have no reason to fear the deadly “second wave” that has no basis in science.
So, to be listed as a probable case, it is not necessary that the person test positive for SARS-CoV-2 in a PCR assay. However, to be diagnosed as a “confirmed case,” it is sufficient that a person have a “laboratory confirmation of SARS-CoV-2 infection using a validated assay, consisting of positive nucleic acid amplification test (NAAT; e.g. real-time PCR or nucleic acid sequencing) on at least one specific genome target.”
Ontario, like most jurisdictions in the Western world, uses the PCR assay recommended by the World Health Organization (WHO). Ontario has developed its own protocols for its use, described below. The WHO promoted that assay on the basis of a submission of a paper, “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR,” authored by German scientists Victor Corman and Christian Drosten. What do we know about that paper?
On 13 January 2020, the WHO published the first version of the Corman-Drosten protocol on its website. It was updated on 17 January 2020. On 21 January 2020, Christian Drosten and Victor Corman submitted their paper describing the protocol for PCR testing for SARS-CoV-2 to the journal Eurosurveillance. It was accepted for publication the next day and was online on 23 January 2020. Two of the authors of the paper sit on the editorial board of Eurosurveillance. There is no evidence that the paper was ever peer-reviewed. It it would be fanciful to imagine that it could have been peer-reviewed in twenty-four hours, since the process normally takes months. The authors claim in that paper that the “novel coronavirus” posed a threat (already in the early days of January 2020) as well as a challenge to health laboratories since “virus isolates are unavailable.” Their aim was “to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available.” So, they developed a diagnostic workflow “relying on close genetic relatedness of [SARS-CoV-2] with SARS coronavirus, making use of synthetic nucleic acid technology” (all highlights added). In other words, the diagnostic “test” in use in Ontario (and most of the Western world thanks to its promotion by the WHO) uses a computer-generated model based on the SARS virus. The subsequent corrections are irrelevant to the protocols promoted in the original paper.
Why did Ontario officials choose the Corman-Drosten PCR protocol as a diagnostic test for determining the prevalence of SARS-CoV-2 in the province? Many scientists are reviewing the Corman-Drosten protocols and discovering fatal flaws throughout the entire work. Most notably, an International Consortium of Scientists in Life Sciences has performed an external review, in light of the fact that the paper had never been reviewed and it was forwarded to the WHO and promoted by that organization for worldwide use under suspicious circumstances. The Consortium includes twenty-two highly qualified scientists, specialists in the field of PCR testing. Their review is detailed and highly critical as you can see from the summary of the errors they found:
“The Corman-Drosten paper contains the following specific errors:
- There exists no specified reason to use these extremely high concentrations of primers in this protocol. The described concentrations lead to increased nonspecific bindings and PCR product amplifications, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- Six unspecified wobbly positions will introduce an enormous variability in the real world laboratory implementations of this test; the confusing nonspecific description in the Corman-Drosten paper is not suitable as a Standard Operational Protocol making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- The test cannot discriminate between the whole virus and viral fragments. Therefore, the test cannot be used as a diagnostic for intact (infectious) viruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus and make inferences about the presence of an infection.
- A difference of 10° C with respect to the annealing temperature Tm for primer pair1 (RdRp_SARSr_F and RdRp_SARSr_R) also makes the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- A severe error is the omission of a Ct value at which a sample is considered positive and negative. This Ct value is also not found in follow-up submissions making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- The PCR products have not been validated at the molecular level. This fact makes the protocol useless as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- The PCR test contains neither a unique positive control to evaluate its specificity for SARS-CoV-2 nor a negative control to exclude the presence of other coronaviruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- The test design in the Corman-Drosten paper is so vague and flawed that one can go in dozens of different directions; nothing is standardized and there is no SOP. This highly questions the scientific validity of the test and makes it unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- Most likely, the Corman-Drosten paper was not peer-reviewed making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
- We find severe conflicts of interest for at least four authors, in addition to the fact that two of the authors of the Corman-Drosten paper (Christian Drosten and Chantal Reusken) are members of the editorial board of Eurosurveillance. A conflict of interest was added on July 29 2020 (Olfert Landt is CEO of TIB-Molbiol; Marco Kaiser is senior researcher at GenExpress and serves as scientific advisor for TIB-Molbiol), that was not declared in the original version (and still is missing in the PubMed version); TIB-Molbiol is the company which was “the first” to produce PCR kits (Light Mix) based on the protocol published in the Corman-Drosten manuscript, and according to their own words, they distributed these PCR-test kits before the publication was even submitted [20]; further, Victor Corman & Christian Drosten failed to mention their second affiliation: the commercial test laboratory “Labor Berlin”. Both are responsible for the virus diagnostics there [21] and the company operates in the realm of real time PCR-testing.
In light of our re-examination of the test protocol to identify SARS-CoV-2 described in the Corman-Drosten paper we have identified concerning errors and inherent fallacies which render the SARS-CoV-2 PCR test useless.”
The Consortium calls upon Eurosurveillance to withdraw the paper. Eurosurveillance has agreed to answer by the end of January 2021.
In the body of the external review, we read the following: “In case of virus detection, >35 cycles only detects signals which do not correlate with infectious virus as determined by isolation in cell culture [reviewed in 2]; if someone is tested by PCR as positive when a threshold of 35 cycles or higher is used (as is the case in most laboratories in Europe & the US), the probability that said person is actually infected is less than 3%, the probability that said result is a false positive is 97%.” (emphasis added)
Public Health Ontario publishes detailed, up-to-date reference guides for all aspects of its COVID-19 policies. To discover the prescribed Ct (cycle threshold, or number of amplifications) that are in use in any of the forty laboratories that perform the PCR assays is not an easy task. The document “An Overview of Cycle Threshold Values and their Role in SARS-CoV-2 Real-Time PCR Test Interpretation” reads, “Based on PHO Laboratory data, the rate of false positive tests that are later determined to be negative requiring results to be corrected is extremely low. How commonly this occurs in the province is not known, as individual reports that are corrected are not centrally documented. In Ontario, incidents of a significant number of specimens (as determined by the testing laboratory) with false positive results are notified to the Laboratories and Genetics Branch of the Ministry of Health, and to IQMH.” How those labs determine their own false positive rate is not clear. How Public Health Ontario knows that the false-positive rate is “extremely low” is a mystery. Public Health Ontario presumes that, “In general, specimens with Ct values well below the assay cut-off for positivity (e.g. Ct < 35 with the laboratory positivity cut-off for that assay set at Ct = 38) are less likely to be false positive.” If the Consortium’s analysis is accurate, there should be a huge false-positive rate in Ontario. The province does acknowledge that there is no published research to support their claims.
On 15 November 2020, a group of scientists in Manitoba published, in the journal Clinical Infectious Disease, the peer-reviewed results of their research. “Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples” documents their attempt to grow the SARS-CoV-2 virus in cell cultures from the products of PCR tests. The researchers took SARS-CoV-2 samples from positive RT-PCR tests to determine their ability to infect Vero cell lines. In no case did a sample that was deemed positive after more than twenty-four cycles of amplification result in a viable virus. In other words, the test was picking up fragments of material that may have once belonged to a virus, but that were now simply waste material floating in the body, with no ability to infect the subject of the PCR assay or others. They conclude: “These results demonstrate that infectivity (as defined by growth in cell culture) is significantly reduced when RT-PCR Ct values are > 24. For every 1-unit increase in Ct, the odds ratio for infectivity decreased by 32%. The high specificity of Ct and STT [symptom to test time] suggests that Ct values > 24, along with duration of symptoms > 8 days, may be used in combination to determine duration of infectivity in patients. Positive cell culture results in our study were most likely between days 1 and 5. This finding is consistent with existing literature.” In other words, sick people should stay home. However, there is no scientific justification for forcing those who test positive for SARS-CoV-2 and are not in the early stages of the illness to isolate themselves. Importantly, the cycle threshold used in PCR assays in Ontario is finding debris that, as Kary Mullis and the Consortium warned, is meaningless.
Ontario guidelines require that “All asymptomatic individuals who have a first-time positive test must be managed as if they have current COVID-19 infection in terms of immediate self-isolation until cleared …” In light of the published findings from Manitoba, it would seem that the cycle threshold should be reduced to twenty-four before such measures are taken. Moreover, the publication of “cases” in Ontario, based on RT-PCR cycles of thirty-eight, is irresponsible. It may have the effect of instilling fear in the population that a virus is out of control. If the Consortium, the authors of the Clinical Disease Infections paper, and Kary Mullis are correct, the so-called cases are based on meaningless data.
Why is the province imposing lockdown measures based on these PCR assays? Why is the government of Ontario forcing the cohorts of the population that are least affected by SARS-CoV-2 to forfeit their social and economic lives?
Sincerely,
Paul Jackson, PhD