Letter to the WHO About PCR Testing Governance

This post includes copies of letters addressed to UK government, the WHO and to the pharmaceutical approval agency MHRA about the PCR tests and Lateral Flow Tests efficacy and robustness.  Including questions on why international agencies and governments have ignored, or possibly used, the knowledge gained from previous use of such tests in this pandemic. 

The bottom letter is one sent to the MHRA in March 2021 to ask about the safety of the vaccines being used in the pandemic and whether or not the vaccines are more dangerous to the most vulnerable in society.

Both letters have not been responded to.

Date: 14/02/2021

Questions to the WHO Relating to the Current CoVid-19 Crisis

Majority of countries in western world is in chaos suffering from the backlash of government decisions regarding the CoVid pandemic, but, there are many unanswered questions that need answering to close gaps in the reality we have all been living and one perceived by media, governments and international organisations. I for one have been attempting to receive some answers since Spring 2020. I would appreciate some time to help clear up some issues of pandemic management that appears not to correlate with knowledge, science and experience gathered from previous outbreaks. Your time is much appreciated.

In the WHO’s guidance, dated 19th March 2020, you advised in the case of patients who are deceased to consider autopsy material including lung tissue. This is further discussed in the update (11th September 2020) when you advice ‘taking swabs, needle biopsy or tissue specimens, including lung tissue for further pathological and microbiological testing – (SARS-COV-2 is most frequently detected in respiratory material and, therefore respiratory samples remain the sample type of choice for diagnosis’). In regard to death reporting and certification, many governments issued instructions to hospitals to record cause of death as a CoVid-19 death even without something simple as performing a diagnostic test to find the real cause of death i.e. if it was thought likely the person has CoVid-19, even when there is no test actioned. This is then presented to the unsuspecting public through media broadcasts knowing many do not realise how many people die each year or the specific details that are written on cause of death reports usually. Is this something the WHO advises in any circumstances to give an accurate cause of death determination in a pandemic? Would the WHO normally advice governments to interfere in normal hospital processes to bypass normal investigation into causes of death, in a pandemic? If not, why do you think this has occurred in all UN member states with the CoVid-19 pandemic?

To further exasperate this, there does not appear to be any data available to confirm any pathological or microbiological testing has occurred to confirm CoVid-19 was the real cause of death throughout the pandemic. Again, is this something the WHO would recommend as a standard practice in dealing with data collection and reporting in a pandemic type situation? Furthermore, is it correct practice for accurate and robust data collection to determine the status of a viral outbreak to add deaths by suicides, car accidents, cancers, heart deceases or other respiratory infections, etc. onto the virus mortality statistics, if the individuals tested positive (i.e. with PCR) at some time in the past or if doctors thought it likely that CoVid-19 was the cause of death even though symptoms are very similar to other coronavirus symptoms, especially influenza (or pneumonia). This is what has/is occurring in the majority of UN member states! Would this not give an inaccurate representation of the pandemic, which is then presented to an unsuspecting public and help spread fear throughout societies?

In addition, the vast majority of UN member states governments in 2020 oversaw the transfer of suspected CoVid-19 patients into care-homes where the most vulnerable and the most at risk of serious illness or death reside. Would the WHO care to comment on why all governments, not just a few, decided that this was the correct course of action at the time and where did governments received this type of guidance.

In the 11th September 2020 guidance, you state SARS-COV-2 is an enveloped, positive sense, single stranded ribonucleic acid (RNA) virus with a 30-kb genome. This appears similar to many other coronaviruses which have an RNA genome between 27 and 32kb in length. Some which gives rather mild illnesses, i.e. the common cold, some which people wouldn’t even know they have, and some like influenza, SARS-COV-1, MERS and SARS-COV-2, which can severely impact people’s health. The question is how does any type of binary PCR testing (which is what has / is being used) or the interpretation of the results distinguish between the various types of viruses when the test involves amplification of any particle which is present in the sample and is directly related to the number of cycles (some RT-PCR used during this pandemic goes through 35 cycles (35billion new copies of any particle is created), some PCR tests even as much as 50 cycles (which medical experts and the WHO all know from previous outbreaks and use of PCR testing (most recent being Ebola outbreak) is excessive)) along with the control of temperatures, transportation and storage of samples? I ask because if you can amplify any one single particle or molecule up-to something that can be measured, which PCR can do, then there is just very few particles or (viral) fragments that someone does not have at least one single one of them at any one time, especially during the winter months. So the greater the amplification cycle the greater chance the PCR system can be misused and the greater the chance that the results are in-fact meaningless in medical science terms, especially with binary reporting. Particularly, when you consider this with the addition of psychological mindsets of the people interpreting the results after they have been exposed to repeated media messages / campaigns about ‘one of the world’s deadliest viruses’, which would surely impede their critical decision making ability. In essence, despite lessons learned previously, a positive result can be given no matter how much RNA is detected or how many cycles are run! – do you agree? To go further would you agree to the following: A binary Yes/No approach to the interpretation of PCR testing, especially RT-PCR, unvalidated against viral culture will result in a high number of false positives with segregation of large numbers of people who are no longer infectious and hence not a threat to public health. Further, you do not recommend viral isolation as a routine diagnostic procedure. But why has the WHO not recommended regular isolation of the virus from positive samples or other viral culture processes to ensure robustness, sensitivity settings, cycle threshold settings and accuracy of tests? Which would give a far more accurate status of any viral outbreak and the ability to ‘fine-tune’ the interpretation of the PCR testing results. Again, this is something that has been learned numerous times and well documented before this crisis began, so why have weaknesses been ignored?

Concurrently, the measurement from PCR tests are not exact and the results are at best ‘inferred’; and PCR by itself is not a testing system, it is just used to make a whole lot of something out of very little of something. The PCR test does not tell you that your sick or if your infectious. And the accuracy, efficacy and robustness of the system is mainly due to the cycle threshold and how the samples are handled. Thus, those labs who use high cycle thresholds can report a binary positive result even though there is very little amount of virus in the amplified sample, especially when decision making is compromised. The relationship between cycle threshold, the ability to interpret the results, how the samples are handled to prevent contamination and whether the result is an actual viral infection or not, is nothing the WHO and government medical advisors are not aware of; and has been investigated on various other viral outbreaks previously. The question is: considering how the samples have been gathered, handled, stored and transported and how easy a PCR test is contaminated and subject to ‘background noise’, at what cycle value threshold is someone still considered infectious or identify whether they are sick at all? The cycle threshold is an important factor hence with higher number of cycles the sample increases the risk of reaching saturation point, which will cause a substantial number of false positives. This cycle threshold is dependent on the type of PCR test used, commercial processes and procedures, the test type, temperature ranges, the method of how the sample was taken, stored and transported. Why is there no guidance from the WHO about these extremely important factors in the testing routine, especially relating to ensuring the saturation point is not reached in any testing protocol, i.e. cycle threshold values and their reference ranges? Should test have a cut-off point so that very small amounts of virus do not trigger a positive result?this point has been raised a number of times in the past and it is unclear why this has not been determined before PCR testing was used in this pandemic.

Important questions that also need answering are: The only criteria required for a case is a PCR positive result, which is prone to misinterpretation, too high cycle threshold (which has been the case since the start) and high risk of contamination. What is the definition of a confirmed CoVid-19 case? And judging by what has been said so far, are PCR tests inherently unreliable? Can this unreliability lead to clinical reasoning and evidence based medicine being ignored?; as a positive PCR test alone should not equal CoVid-19 but does despite lessons learned previously on the flaws of PCR testing. Hence, political decisions can be operating on a non-evidence based way when it comes to pandemic management; and the impacts to society and individuals including unnecessary prescription or treatment or therapy, which could cause other unintended adverse health effects. There are many examples of political decisions ignoring scientific and evidence based research throughout this crisis (there is an argument that over 40 years of science has been ignored).

The WHO also state in their guidance the complexity of adequate sampling, laboratory analysis, and interpretation of results, collection and laboratory diagnosis should be performed by trained and competent operators. Also in the document, you state that co-infections of SARS-COV-2 with other pathogens have been reported, thus a positive test for another pathogen does not rule out COVID-19. You also state there is a risk of false positive and false negative SARS-COV-2 results if testing is not performed with adequate assays or not done under adequate conditions. Would the WHO say that pop-up testing centres in unsheltered car-parks, airports, sports grounds, colleges / universities, dusty churches or mosques, shopping centres, etc. where the overwhelming majority (>95% est.) of samples were taken that are open to be contaminated in many different ways with many different particles, which is one of the main flaws of PCR; and where samples are taken by untrained personnel, sometimes by the patient themselves, is sufficient to gain an accurate picture of SARS-COV-2 cases, thus, the status of the pandemic or does this scenario ensure the results are suspect to drastic increase false positives, i.e. resulting in ambiguous or misleading results? Hence, does the increase in testing done this way lead to an increase in the risk of “sample contamination” and thus an increase in CoVid-19 cases, hence, leading to mass panic spread amongst the unsuspecting public?, as I’m sure you are aware occurred with PCR testing with other viral outbreaks previously – would you care to comment on this.

The robustness and accuracy of fusion of multiple tests is extremely important in identifying the status of any viral of bacterial outbreak / pandemic. The public is informed that the PCR tests are the gold standard in identifying SARS-COV-2, why then would hospitals retest a patient multiple times in a very short period of time if a negative is received? Is it because the PCR test is not a diagnostic test and thus prone to high error rates when results are interpreted from the PCR processes? Many patients have reported being tested several times before the result is believed, can the WHO explain this procedure or what appears to be the lack of confidence in the testing process?

Further, you identify the possibility of a negative result not ruling out a SARS-COV-2 infection, however, there is no mention of what rules out a false positive SARS-COV-2 infection which is equally important especially in a pandemic situation which has severe societal and economic disruption. Can you briefly explain why?

In the section ‘Rapid diagnosis test based on antigen detection’, you state ‘a false positive results may occur if the antibodies on the test strip also recognise antigens of viruses other than SARS-COV-2, such as other human coronaviruses’. You also state, ‘the sensitivity of different Rapid Diagnostic tests compared to rRT-PCR in specimens for URT (swabs) appears to be highly variable, but specifically is consistently reported to be high’. You further state that ‘antibody diagnosis tests (including lateral flow tests) for coronavirus may also cross-react with other pathogens, including other human coronaviruses, or with pre-existing conditions and thus yield false positive results’. How would you accurately interpret the serology of a test to correctly diagnose a possible infection, i.e. a SARS-COV-2 infection from the may other types of infection? And why has PCR tests alone been used to report a CoVid-19 infection or cause of death (when used) when more accurate tests are available?

The WHO admitted on 7 December 2020 that ‘manual adjustment of the PCR positivity threshold is necessary to account for any background noise which may lead to a specimen with a high cycle threshold (Ct) value result being interpreted as a positive result’ – Can these background noises be other coronaviruses or infections?; and ‘positive results occur a high levels of circulating virus (cycle loads) at relatively low cycles, thus the Ct values will be low’; and ‘the distinction between background noise and actual presence of the target virus is difficult to ascertain with many cycles’ – high cycle rate issues was already known to be a major issue with PCR testing, so why have they consciously been set high and why have manufacturers been permitted to set their own target threshold?. The WHO already knew these are issues with PCR testing prior to CoVid-19, the WHO already have research on other viral outbreaks which determined thusly. And even the inventor realised this exact issue was occurring when PCR was used to detect the HIV virus many years ago; yet, the exact scenario continued/s to repeat itself in the exact same way in other viral outbreaks, so why was this not prevented from the very start of the pandemic? It has to be noted: Mr Mullis warned that PCR testing can be used incorrectly and notably went on to publicly say many are misinterpreting the results with PCR to give the illusion that a viral infection is present (i.e. you will eventually find what it is your looking for due to the amplifications involved), he also stated, ‘PCR, when following the correct procedures, cannot be misused unintentionally.’ Meaning, that any misuse of the PCR system in the testing procedure is intentional, such as setting the cycle threshold high or the methods used to handle the samples to increase the risk of contamination. Would the WHO care to comment on Mr Mullis statements (gathered from interviews) in relation to the protocols and strategies used regarding PCR testing throughout this CoVid-19 crisis. Would these ‘background noises’ combined with high cycle thresholds and inferred results from the tests, removal of normal investigations into cause of death and how CoVid-19 deaths are related to a positive result sometime in the past account for the drop of between 95-97% of deaths in 2020 compared to previous years of flu / pneumonia and the high rate of deaths accountable to CoVid-19? Furthermore, would this not point to the threat of CoVid-19 being significantly less than what in being presented to the public through political and mainstream media avenues?

You recommend laboratories should have measures in place to reduce the potential for false positives rRT-PCR results and have a strategy for the management of equivocal results. Is it wise to permit private laboratories to set their own thresholds, as it would be in their best financial interests to keep positive results relatively high? Hence, it would benefit them to keep the cycle threshold high to return a high number of positives and thus justify government ordering more test kits and continue requiring their services. Already the wealthiest people in the world have made just shy of $1Trillion from the start of this pandemic and it has to be noted that many politicians (who are directly behind continued lock-downs), friends, colleagues and family are also financially benefiting from continued lock-downs, use of test kits, PPE, etc. Thus, would it not be in their best best financial interest also to keep the cycle thresholds high and ensure samples are collected in the methods described previously to increase the risk of contamination and thus high number of ‘cases’?obviously as long as civil unrest is kept to a controllable level. Hence, these attributes can be adjusted / constrained to present to the public that vaccines are working or that another coronavirus strain is present causing an increase in infection rates. Can this be the case? This business model would also suit Big Pharma as they have already made est. ~$150billion revenue from their first orders of vaccines.

The WHO changed their decades old guidance regarding the use of face-masks (moreover the potential dangers) and the possibility of more dangerous outbreaks later by quarantining perfectly healthy people during a pandemic (i.e. to prevent herd immunity taking place as what does every year with other viral outbreaks). It is unclear what new science, evidence or data caused these changes. Can you please provide or send me a link to the new science: This science should include particle and filter size data and what other mechanisms or data was used to change the guidance regarding face-masks; and what new science was available from the brief few months of the pandemic which made the WHO change their 40years-old guidance about quarantining perfectly healthy people, which has prevented people from being exposed to small doses of the virus to give their immune system chance to identify and fight off a greater exposure later.

The United Nations (UN) have a number of projects live at the present time including the Roadmap on Vaccinations project, more specifically the project aim of ‘countering vaccine hesitancy’, which is scheduled to occur from 2018-2022 with the end result being a Health passport, which is live in China now. This project is being managed in collaboration with the Gates foundation with the Vaccine Alliance and Big Pharma, the UN, the WHO, the World Economic Forum (WEF) and the World Bank. How did the international community and national governments, including the WHO, intend to complete a monumental social engineering feat to satisfy project aims in such a short timespan, without the use of a massive media campaign surrounding the very thing vaccines are used for? Would you care to give details on what the original strategy was to complete this project? Would the scenario described in the previous 2 paragraphs also help satisfy the objectives of the UN Roadmap on Vaccinations along with other UN and WEF related projects!

The WHO recognises that a certain percentage of healthy people will die from the yearly influenza vaccine and the number of people who will die as a result is dependent on how strong their immune system is. Thus, the more people in the at risk category or those whose immune systems are already compromised that are injected with the vaccine will subsequently suffer fatal reactions. The expected death rate for the winter flu jab, which has been under development and improvement for over 50 years, is considerably lower than the global death rate for flu. However what is the expected death rate of these new CoVid vaccines (e..g Pfizer, Astra-Zenica) considering they have been developed from ‘conception’ within a matter of 5-6 months and as such have not had time for correct trails or to gather a list of side effects before governments authorised mass public use? Additionally, the vaccines have been rolled-out in care-homes first, especially in the UK. This appears to be the trigger for the highest number of deaths reported from care-homes in a one month period (Jan 2021), which have been added to CoVid death statistics. Would the WHO recommend the UK government as a matter of urgency that these deaths from those who have had the vaccine are fully investigated? Additionally, why have governments, and the WHO, chosen to ignore the relationships between the rise in deaths and vaccine roll-out, and chosen not to pause the expansion of vaccines until the cause of deaths amongst the most vulnerable in society have been fully determined? Additionally, can you provide an explanation why there is a media blackout about the rising deaths in care-homes at the point when vaccines where given?; are the most vulnerable seen as collateral damage in the rush to achieve project goals?

In 2020, the overwhelming majority of countries, in general, have not seen anything abnormal in mortality trends or rates; further, these countries mortality rates were on-par with predictions from 2019. Those countries that did see excess deaths in 2020 compared to previous years predicted higher than normal mortality rates for 2020/21 due to the relationship between the number of people over a certain age in demographics of the country (i.e. in the ‘at risk’ category). The UK especially (that has more people over 85years old than at any other time in history), in 2019 predicted a significant increase in deaths for the next 4-5 years before CoVid-19 became public knowledge or was even identified. Thus, I would like to be blunt with this, lets be clear uncomfortable question: With what has already been said and your knowledge and experience gathered over the years regarding PCR testing strategies and mechanisms or moreover the weaknesses of them (which on the surface have been largely ignored throughout this crisis); and the previous history of rushing through experimental vaccines, which has had detrimental impact to health; Can PCR testing with methods used to collect, transport, pool samples together, along with the psychological impacts caused by media coverage, as per above (what has/is occurring), to gather a binary result of a PCR test, be misused to exaggerate the status of a viral outbreak and spread unfounded fear through society? This question is important because from the knowledge gained on the PCR method, along with the test itself, which appears to be at the mercy of many contamination factors and misinterpretation issues; it could be easily used to give the illusion of the presence of something that is not a threat or meaningful in any way; akin to what the inventor inferred to years ago. As a result, the PCR system, if used and governed in a specific manner, can be exploited to help leaders satisfy their project aims regarding countering vaccination hesitancy, via case numbers and incorrect reporting of cause of death, and thus help Big Pharma’s failing business models. Do you agree that this can be a possibility with PCR testing? – can you briefly explain your answer.

Government’s have funded research as to how best to ‘psychologically manipulate behavioural change’ in society, which the WHO is no doubt aware of. In the UK, this research is provided by Sage, NERVTAG, SPI-M, SPI-B, which concentrates on strategies and methods on how to spread fear through society. Similar strategies have been actioned in other UN member states with varying degrees of success. Combined with this are the issues regarding possible incorrect and inaccurate binary results from PCR testing and how the causes of deaths have been reported to purposely favour CoVid-19. Additionally, the media coverage on CoVid-19 has been world class, which only works to spread fear through society and help to psychologically persuade people that vaccines are the only way out of the lock-downs. These ‘things’ cannot be argued against. All these combined will weaken any unsuspecting individuals critical thinking ability and instead spark the inalienable reaction to do whatever it takes to prevent deaths (including their own), save their livelihoods and businesses, and be able to see their family and friends. Hence, the decision making ability of individuals have been considerably compromised by the above ‘things’ and as such the constant ‘mantra’ of ‘vaccines being the only way out of this’, could be argued as a form of coercion. Therefore, as people clearly have little to no understanding or comprehension of what they are volunteering for or have knowledge of most of the issues raised above, are people able to give clear, precise and informed consent to being injected with new, arguably experimental, vaccines? This notwithstanding, this last question is far more important: It would be hard to say that people are consenting to being vaccinated with the full knowledge, understanding or comprehension of what PCR testing is, which have been fraudulently marketed as CoVid tests, and it’s weaknesses (that can be exploited); what research the governments have been using to achieve compliance; or what side effects will be from these vaccines, especially those in care homes which have not been given a choice. Most people have been scared to death by constant repeated media exposure of ‘one of the worlds deadliest viruses’, which the data does not support. Governments have instructed hospitals to bypass normal investigations into the causes of deaths, which only adds to deaths caused by the virus; and of-course the subsequent media blackout on the increases in deaths from care-homes when the vaccines were rolled out and any news or opinions in contrary to government narratives cancelled / banned or demonised on media platforms, including experts in virology. The rush to get entire societies vaccinated with vaccines that no-one knows even works or what the long term implication are (from government’s own marketing material); the fact that many deaths have already been recorded and suspected to be from the vaccines themselves, especially in care-homes. To add to all this, legislations have been created to give legal indemnity to pharmaceutical companies even though governments repeated messages that the vaccines are safe, which should spark alarm bells for those who know, but the majority are in the dark about this. How does this situation satisfy the constraints of the Nuremberg code (1947), which is developed to prevent unsuspecting people from being experimented on (physically or mentally) by those in positions of power? Can you briefly explain your answer.

The reality is many people living through this crisis does not match the perceived realty presented by political leaders, international institutions or through main-stream media. There are many gaps, and many issues regarding how the pandemic has been governed, along with the question of where all the usual yearly ailments have suddenly gone. Answers to the above questions will help closing these and more gaps.

I thank you for your time and patience,

Dr. Holden

Letter to the MHRA asking about safety of vaccines

Date: 8th March 2021.

To Whom it may concern,

I am sending this email just to ask some simple questions which I would be extremely grateful if you could answer.

The CoVid-19 vaccines have been given emergency approval, yet, it has passed rigorous safety validations. Can you briefly give details of what the difference is between being given emergency approval and being approved and authorised in general. Further, what gives the vaccines temporary approval when the public has been informed it has passed the same safety approvals as other more mature vaccines, such as the flu vaccine?

The Pfizer vaccine injects people with the CoVid-19 protein, but, it is unclear what impacts this will have on human cells, or what health implications it will have to those who already have compromised immune systems or whether this protein will give a positive test result with PCR testing. Can you please briefly explain these issues?

Can you briefly explain how this protein ‘signature’ will help reduce the health impacts of a CoVid-19 viral infection apart from potentially speeding up the immune system response to a recognised CoVid-19 infection, which would have occurred naturally with herd immunity if millions of healthy people were not quarantined?

Would the vaccine not cause severe health implications to those the vaccine is marketed to protect as the body would see this protein as an invader, because proteins are the bodies communication medium, and activate the bodies natural response to it and place additional strain to an already compromised immune system causing ‘side effects’ or other health impacts (including premature death)?

The Oxford-AstraZeneca vaccine uses an adenoviral vector which delivers a gene which encodes a spiked protein to cells, which could trigger a coronavirus infection in people. Would you comment on this statement? So instead of delivering a protein our cells, like the Pfizer vaccine, our cells would create the protein from the cytoplasm thus coating the cells, which then prompts the immune system to respond. Is this not potentially more dangerous to those with an already compromised immune system?

Also, if people already had the CoVid virus, which the majority most likely have had different doses / infections of irrespective of lock-downs, would this not make this type of vaccine significantly less effective as the body will fight the viral vector? Would you care to comment?

Lastly, the homology between the SARS-COV-2 spike protein and Syncytin-1, essential for placental development, is almost identical. Is it possible that the anti-bodies produced by the vaccines could cross react with the placental proteins that would negatively impact fertility? If not, what is the evidence that shows this would not occur?

The government are thinking of mixing vaccines, as one is a mRNA and the others are mostly monovalent vaccines; it is unclear what science is available to justify this strategy. Can you please provide details.

Thank you for your time.

Kind Regards,

Dr Holden.

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