The independent, interdisciplinary science platform NEXT LEVEL has asked the German Federal Ministry of Health (BMG) and the Robert Koch Institute (RKI) under the Freedom of Information Act (IFG) whether the authorities have documentation on negative controls with samples from healthy people in connection with the cultivation and sequencing of “SARS-CoV-2” and the “measles virus” in accordance with the Infection Protection Act (IfSG).
Response from the BMG: “Accordingly, the Federal Ministry of Health (BMG) does not have any documentation on pathogen detection – in particular for the measles virus and SARS-CoV-2 – as requested by you under point 1, in which no sequencing was used as evidence and therefore no associated documents on negative controls carried out with samples from healthy persons”.
Response from the RKI (subordinate to the BMG): “Both the cultivation of measles and SARS-CoV-2 viruses and the genome sequencing of such viruses are of course carried out at the RKI in accordance with the standards of good scientific practice. However, these standards do not require negative samples to be included in virus cultivation or genome sequencing. Instead, virus detection is carried out in advance by means of molecular detection using PCR and/or sequencing. Therefore, only pre-analysed samples that are already known to contain the virus are used for virus cultivation or genome sequencing. Documentation and results on negative controls with healthy patient samples in the cultivation of measles viruses and SARS-CoV-2 or the genome sequencing of such viruses are therefore not available.”
When asked by NEXT LEVEL whether at least the methods of the preliminary analyses have been checked, the RKI again refers to the first answer that there are no negative controls with samples from healthy persons.
Thus, there is no documentation available on negative controls with samples from healthy individuals. However, according to DFG Guideline 11 on good scientific practice, every scientific institution – in particular state institutions such as the RKI – is obliged to systematically review all methods used, in particular by means of suitable negative controls. The RKI also confirms this obligation on its own website on good scientific practice. Negative controls are indispensable in virology in particular. They ensure that the results obtained are actually attributable to the sample analysed and are not caused by the experimental setup, the reagents used or other interfering factors. If negative controls with samples from healthy individuals were to provide the same results as the test samples, it could be concluded that the results are not due to the presence of a “virus”. In this case, the methodological basis of virological testing would be fundamentally questioned.
In addition, the BMG makes a fundamental statement on the detection of pathogens using sequencing. The minutes of the RKI crisis team of 22 February 2021 state: “The BMG is of the opinion that sequencing results are not pathogen detection by definition.”
When asked how the statement “BMG is of the opinion that sequencing results are not pathogen detection by definition” should be understood, the BMG replied as follows: “The passage quoted is in connection with a discussion between employees of the RKI and the BMG on reporting obligations under the Infection Protection Act (IfSG), which was conducted and minuted by participants in the relevant meeting of the crisis unit. This is clear both from the heading “Obligation to report sequencing results” preceding the relevant passage and from the text that follows. The statement in question in the context of the discussion at the time about the interpretation of the IfSG means that the term “pathogen detection” in Section 7 (1) IfSG only refers to the primary detection of the pathogen, but not also to further sequencing or fine typing as part of secondary diagnostics (in particular, for example, by special laboratories).”
The BMG thus confirms that sequencing alone does not constitute primary pathogen detection by definition and is therefore not sufficient to confirm the presence of a new “virus” within the meaning of the IfSG.
Of particular relevance in this context is the fact that the first publication on SARS-CoV-2 in Nature provided evidence of the pathogen solely on the basis of sequencing results. However, the PCR test was created and the global pandemic declared on this basis – which, in the opinion of the BMG, does not represent primary pathogen detection.
Central questions that arise from this:
When are the negative controls prescribed by scientific standards carried out with samples from healthy individuals?
When will pseudoscience based on incomplete methodological foundations end?
When do politicians intervene to regulate?
When will the courts take up this issue?
Further information on this and other topics can be found on the science platform NEXT LEVEL – Wissen neu gedacht.
