Identified errors and fallacies of the PCR test

Bartholomeus Lakeman (Ataliwyd y cyfrif) made this Rhyddid Gwybodaeth request to Department of Health and Social Care

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Gwrthodwyd y cais gan Department of Health and Social Care.

Bartholomeus Lakeman (Ataliwyd y cyfrif)

Dear Department of Health and Social Care,
On 24 Jan, Matt Hancock was at Davos with the WEF, the WHO, Bill Gates, many Govt leaders, and Prof Christian Drösten in a meeting regarding its pandemic preparedness plan: it was decided that the Corman-Drösten PCR protocol is to be used in an estimated 70% of all PCR test kits worldwide and so in the UK. This decision was based on a paper called “Detection of 2019 novel Coronavirus (2019-nCoV) by RT PCR” which was published on 23 Jan in ‘Euro Surveill’ by Prof Drösten et al: describing the de facto industry standard protocol for detection of SARSCoV2 by the PCR test; see https://ncbi.nlm.nih.gov/pmc/ articles/PMC6988269/. Published before any covid-19 virus isolate was available: it was based on in silico (theoretical) sequences of the viral genome: and to date no validation has been performed based on isolated SARS-CoV-2 viruses or full-length RNA thereof.

In light of all the consequences resulting from said Corman-Drösten paper for societies worldwide, a group of international independent researchers (e.g. P Borger, Prof. M Ohashi, M. Yeadon, K Corbett, T Binder) performed a point-by-point review of said paper in which (i) all components of the presented test design were cross checked, (ii) the RT-qPCR protocol-recommendations were assesses w.r.t. good laboratory practice, and (iii) parameters examined against relevant scientific literature covering the field.
Subsequently this team of top experts asked ‘Eurosurveill’ for the retraction of this protocol; see http://cormanDröstenreview.com/report/

Their summary catalogue of errors found in said Corman-Drösten paper making the PCR test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus; are:
1) There exists no specified reason to use the extremely high concentrations of primers in this protocol. Its described concentrations lead to increased nonspecific bindings and PCR product amplifications;
2) Its six unspecified wobbly positions will introduce an enormous variability in the real-world laboratory implementations of this test; the confusing nonspecific description in said paper is not suitable as a Standard Operational Protocol (SOP);
3) 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 to identify said virus and make inferences about the presence of an infection;
4) A difference of 10° C with respect to the annealing temperature ™ for primer pair (RdRp_SARSr_F and RdRp_SARSr_R);
5) 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 (a Ct above 30 invalidates the PCR test);
6) 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;
7) 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;
8) The test design in said 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 PCR test;
9) Said paper was not peer-reviewed when accepted for implementating the PCR test;
10) The authors of said paper served a undeclared conflicts of interest: C Drösten and C Reusken are on the editorial board of Eurosurveillance; V Corman & Drösten are affiliated with Labor Berlin operating in the realm of RT PCR-testing; O Landt is CEO of TIB-Molbiol; M Kaiser is senior researcher at GenExpress and at TIB-Molbiol, which was the first to produce PCR kits (Light Mix) based on the protocol published in the Corman-Drösten manuscript, and distributed these PCR-test kits before said paper was submitted.

According to the DHSC: Which of the abovementioned statements and (in the summary catalogue identified) errors and fallacies of the PCR test protocol are incorrect?
Why do said errors and fallacies of the PCR test protocol not render the SARS-CoV-2 PCR test useless?
In light of the injuries on the public resulting from said Corman-Drösten paper and PCR test errors: Would the DHSC be willing to abort said PCR test? And if not: Why not?

Yours faithfully,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

Thank you for your email.

The Freedom of Information Act only applies to recorded information such as paper or electronic archive material. As your correspondence asked for general information and an opinion rather than requesting recorded information or documentation, it did not fall under the provisions of the Act. It will be answered as general correspondence in due course.

Yours sincerely,

FOI Team
Department of Health and Social Care

dangos adrannau a ddyfynnir

Bartholomeus Lakeman (Ataliwyd y cyfrif)

Dear FreedomofInformation,
Thanks for your initial reply:
Yet in light of all the consequences resulting from the use of said PCR test for societies in the UK: it being in the Public interest; the DHSC cannot handle this FOI questions as a general correspondence; rather the DHSC has to provide transparency and accountability in an active manner: It has to answer this FOI in a serious and a genuine manner.
In order to assist you I have specified its questions as follows:
Does DHSC have a record of -or agrees with- that:
1) Matt Hancock was at said meeting in which the Corman- Drösten paper was accepted as part of pandemic preparedness plan;
2) Said paper “Detection of 2019 novel Coronavirus (2019-nCoV) by RT PCR” was the corner-stone/ reason to implement said PCR tests;
3) Said paper -or a similar paper recommending said PCR test- has been discussed or assessed by the scientific advisers or SAGE supporting DHSC, the Cabinet or a committee regarding its (Covid-19) pandemic preparedness or treatment plan;
4) Said advisers, DHSC, the Cabinet and/or said committee did exercise a point-by-point review, or a cross-check on said Corman-Drösten paper or on a similar paper recommending said PCR test, for to use said PCR test a mass on the UK population;
5) Said advisers, DHSC, the Cabinet and/or said committee reviewing said Corman-Drosten paper or a similar paper recommending said PCR test did or did not found the errors as listed in the ‘Summary catalogue of errors found’; listed by said group of international independent researchers.

Yours sincerely,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

Thank you for your further email.

The Freedom of Information Act only applies to recorded information such as paper or electronic archive material. As your correspondence asked for an opinion ("or agrees with") rather than requesting recorded information or documentation, it did not fall under the provisions of the Act. It will be answered as general correspondence in due course.

You may find it helpful to refer to the Information Commissioner’s ‘How to access information from a public body’ webpage. It includes advice for requesters on how to communicate effectively with public authorities, and how to word requests to get the best result. Future requests are less likely to be refused if framed in accordance with these guidelines.

https://ico.org.uk/your-data-matters/off...

Yours sincerely,

FOI Team
Department of Health and Social Care

dangos adrannau a ddyfynnir

Department of Health and Social Care

Our ref: DE-1280723 

   

Dear Mr Lakeman,  
   
Thank you for your correspondence of 8 December about COVID-19 testing. I
have been asked to reply.  
 

The Freedom of Information Act only applies to recorded information such
as paper or electronic archive material. The Act does not cover unrecorded
information that officials may remember, opinions that officials might
have, official advice (apart from past advice the Department of Health has
given, where a record of this has been kept) or requests for an official
policy statement (again, apart from past policy statements, where a record
has been kept).  There is no obligation under the FOI Act for public
authorities to create new information. 

 

Due to the exceptional nature and impact of the pandemic, the approach to
releasing evidence from SAGE has changed significantly from previous
emergencies, where papers and minutes were released only at the resolution
of the situation. In recognition of the need of the public to see the
current scientific advice, the Government has already released many of the
documents discussed at SAGE and its sub-committees since the outbreak
began. More are being released on a weekly basis and can be found
at [1]www.gov.uk by searching for ‘Scientific Advisory Group for
Emergencies COVID-19 response’. 

 

I hope this reply is helpful. 

 
Yours sincerely,  
   
Anthony Moses  
Ministerial Correspondence and Public Enquiries 
Department of Health and Social Care 

  

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Bartholomeus Lakeman (Ataliwyd y cyfrif)

Dear Department of Health and Social Care,
Do you have or had a record of that:
1) Matt Hancock attended (on 23 Jan ‘20) the pandemic preparedness meeting in which the Corman- Drösten paper was accepted?
2) To implement the Covid PCR tests was that reasoned by said Corman- Drösten paper “Detection of 2019 novel Coronavirus or was it due to another paper about the RT PCR test? And if so; which paper?
3) Said paper or a similar paper recommending said PCR test-; Was this discussed or assessed by the Govt scientific advisers, MHRA or SAGE?
4) Prior implementing said PCR test a mass on the UK population: Did said advisers for the DHSC or the Cabinet exercise a point-by-point review, or a cross-check on said Corman-Drösten paper or on a similar paper recommending said PCR test?
5) Said advisers having made aware of the said test’s errors as listed by said group of international independent researchers in the ‘Summary catalogue of errors found’: Bearing that "Science is a history of corrected mistakes“: Did they and the DHSC review their advises on implementing said PCR test a mass on the UK population? And if not; why not?
6) Implementing said PCR test a mass on the UK population: Does that have a relationship with the Cabinet decision “Section 5 2020-2023 Key Treasury objectives for treasury and Home Office consideration 5b(i) and (ii). Damage to the wider economy is only achievable by imposing continuing measures to prevent trading amongst the commerce and service industries as a whole regardless of the size of organization. It is likely that strike action, and more likely, general public disorder will occur, which the government would struggle to crack down on without necessary financial sweeteners including generous benefit packages as proposed in Section 3a and 4 of the memorandum Emergency Financial Infrastructure. Any such disorder will be discouraged by a public health campaign that will bring on board a mixture of health information, analysis and data presented by Government and Independent institutions. All ministers will be complicit in the publication of the health directives using public and private media organizations. The names of considered independent institutions are outlined in Section 11b and 11c of the memorandum. The proposed media organizations are outlined in Section 11e”?

Above issues show that the DHSC has a case to answer this FOI; due to which it should review its reply.

Yours faithfully,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

As you are aware, your correspondence did not meet the criteria of a freedom of information request and is therefore not subject to an internal review. Should you wish to complain about the response you received, you may do so at the following link: https://contactus.dhsc.gov.uk.

You may find it helpful to refer to the Information Commissioner’s Office ‘For the public’ webpages. They include some advice for requesters on how to word requests to get the best result. They are aimed at the general public and provide guidance on how to use section 1 rights responsibly and effectively. Future correspondence is less likely to be refused if framed in accordance with these guidelines.

You can view the relevant section, ‘How should I word my request to get the best result?’, on the How to access information from a public body page of their website.

https://ico.org.uk/for-the-public/offici...

Yours sincerely,

FOI Team
Department of Health and Social Care

dangos adrannau a ddyfynnir