Almost ten months ago, during a business meeting of several days, I was asked by the head of the Medical Department to come to the «Smoking Lounge» of the hotel where we resided to talk about my published critical articles on the subject of «Corona» and in particular on the COVID «vaccines». My behavior was deemed «problematic» because I dared to publicly question the work of Health Authorities and thus of important «Stakeholders.» Based on facts, I tried to explain how I had arrived at my critical attitude. To no avail. This was the last conversation. Shortly afterwards, I decided to hand in my resignation. Colleagues at work had complained anonymously to the management about my articles. This happened in a company that had an «I» for «Integrity» in the official company values, which had been elaborated at great expense by a professional marketing agency and which were actually to be lived by all employees.
To this day, I have never regretted leaving the company. The head of Medical Department never said «goodbye» to me either verbally or in writing, which says a lot about the humanity that has been completely lost in the last two years.
As a Pharmacist who worked for over 12 years in a global pharmaceutical company, first in Regulatory Affairs Department, then in the Medical Department, I assumed that all my colleagues, who were also scientifically trained, could interpret studies. Early on, I tried to seek discussion and show that the efficacy endpoints defined in the pivotal studies of the COVID «vaccines» were not clinically relevant after all because they only captured trivial events. After publication of the results of the pivotal studies, I, like probably 100,000 other physicians and scientists, expressed the opinion that these «vaccines» had shown exactly nothing. I was astonished to discover that in my working environment, in which everyone should have the necessary expertise to assess the data, there was no interest in a discussion. On the contrary: If I dared to address the contradictions, the faces virtually froze, as in a zoom meeting when the Internet connection breaks down.
The public subsequently debated whether it was «ok» to show the efficacy of COVID «vaccines» based on Relative Risk Reduction (RRR) or whether it would be better to do so based on Absolute Risk Reduction (ARR). Official experts, who of course are only chosen as such when they represent the opinion of health authorities, were of the opinion that it is of course «correct» to communicate the efficacy of COVID «vaccines» based on Relative Risk Reduction, since this has always been done for vaccines. [1] Is this enough of an explanation? Probably not.
Science is a «search for truth»
Science is, in an ideal world, a «search for the truth»: The task of science, at least in my point of view, is to find out whether a method is effective or not. To do this, the right questions must be asked, the right experimental conditions must be selected, and the experiment must be conducted correctly.
Usually, the efficacy of a drug is investigated in two groups in a prospectively set-up study: one group receives the drug under investigation, the other group an established comparator or placebo. Over a certain period of time, usually at least 1 year, the number of cases of a disease against which the new drug is supposed to be effective («endpoint events») is observed in the two groups. If significantly fewer disease cases occur in the group where the new drug is administered than in the comparison group, it is considered effective. Of course, there must be a total of many cases of disease in the study. On the one hand, because otherwise the question would arise as to why a drug is being developed at all if the disease does not occur at a relevant frequency, and on the other hand, because a statistically sufficiently large difference must be shown between the two groups in order to obtain approval. Clean science is simple and easy to understand.
Efficacy based on RRR without indication of case numbers: «Fake News»?
In the case of the Pfizer «vaccine», a total of 42,000 study participants in the vaccine group recorded 8, in the placebo group 162 «confirmed COVID illnesses», which were trivial events such as headache, sore throat, fever, etc. in combination with a positive PCR test. [2] The number of cases in the pivotal trials of the Moderna «vaccine» were in a similar range. [3]
Thus, based on the more than 42,000 study participants, disease cases occurred in 0.04% in the vaccine group and in 0.74% in the placebo group, i.e., hardly anyone in either group, despite «pandemic». The ARR was consequently 0.74%-0.04%=0.7% and was thus devastatingly small, or the derived benefit for minor events de facto non-existent.
Severe COVID disease occurred (no earlier than 7 days after the 2nd dose, as defined in advance in the study protocol) in only 4 cases among the 42,000 study participants: 3 cases were recorded in the placebo group, 1 case in the vaccine group. Based on these case numbers, which were within the range of statistical chance, an efficacy of 66.4% was reported in the December 2020 SMPC approved by Swissmedic.
If the case numbers were 3 versus 0, an efficacy of 100% could even be proclaimed based on the RRR. Is this not a bit very unscientific and misleading? Personally, I find few arguments to answer the question with «no». On the contrary, as was also questioned in a commentary in the Deutsches Ärzteblatt 2021, shouldn't an efficacy calculated based on the RRR and proclaimed without the underlying case numbers, when these case numbers are in the range of statistical chance, be classified as «fake news»? [4]
Meanwhile, the RRR game seems to be blithely continuing: On June 15, 2022, Swissmedic announced that it had granted a temporary marketing authorization for Pavloxid®, another drug for the treatment of COVID-19 [5]. In the underlying pivotal study, an efficacy of 89% was calculated for COVID hospitalizations and deaths based on RRR compared to placebo in high-risk patients who took the drug within three days of first symptoms: 0.77% (3 of 389 ) of study participants in the Pavloxid® group and 7.01% (27 of 385 patients) in the placebo group had been hospitalized with a positive PCR test. The ARR was thus 6.2%. The observation period was just 28 days [6]. While only unvaccinated individuals were included in the study (prior COVID "vaccination was an exclusion criterion), the drug will now be used in all high-risk patients. Global data have long shown that vaccinated individuals are much more susceptible to COVID disease, severe courses, and deaths [7]. Thus, the study was conducted in an unrepresentative, presumably much healthier population. In the U.S., it has been emerging since late May 2022 that patients who have taken Pavloxid® are increasingly reporting a «rebound phenomenon,» the occurrence of renewed symptoms after cessation of therapy. [8]
Now that serious deficiencies have come to light in the registration data of the hastily approved COVID «vaccines» [9][10], a healthy caution is probably also warranted with regard to COVID «therapies».
How reliable are published study results?
As early as 2005, Prof. John Ioannidis denounced that most published study results were false and not reproducible [11]. In a project costing two million US dollars and lasting eight years, researchers tried to repeat as accurately as possible important experiments from basic cancer research that had been described in renowned scientific journals such as «Nature», «Cell», «Science», and to confirm the results. However: only 54 of 112 results turned out the same in the repetition as in the original experiment. The majority of the reviewed experiments could not be confirmed or the result differed significantly from the original experiment: The effect was on average 85 percent smaller when repeated. [12]
Science versus «scientism»
Normally, science thrives on a lively discourse: published results are questioned and discussed lively in the scientific community. In the last two years, it has become very quiet. Published data, regardless of how solid or unsound they are, are placed on a golden pedestal as an absolute inviolable truth and revered as an «icon of sacred science in Corona times.»
Science has undoubtedly taken on the character of a religion in «Corona times». Whoever doubts, no matter how well-founded, is made out to be a heretic. Has it not always been legitimate to question? Hasn't human history always shown that it can be dangerous not to approach life with a healthy dose of mistrust?
It seems almost obvious that the goal is to publicly corner people who ask critical questions and, if possible, exclude them from society. Questioners are almost portrayed as radicalized «cult members» who have strayed from the right path of the «one and only Corona truth». But: Who is the actually dangerous «sect» here?
We all know that we live in a time where the truth is upside down, where facts are twisted and evil is presented as supposedly good.
Saying «no» and questioning is not an easy exercise. Many who have done so in the last two years have lost some, some even much. But many have also gained much that is new. Every questioner and «No»-sayer who has set an example in his or her own way is a hero of today.
Isn't it nice and reassuring to be able to look in the mirror with a clear conscience and pride, knowing that we have not blindly gone along with the crowd, but have shown backbone and stood up for the truth?
I would like to encourage everyone to continue to do this, each according to his abilities.
Translated with www.DeepL.com/Translator (free version)
The original article in German from 15th June 2022 is available at:
https://www.katischepis.ch/post/wissenschaft-auf-abwegen
Sources:
[1] https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00069-0/fulltext [2] https://www.nejm.org/doi/10.1056/NEJMoa2034577?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
[3] https://www.nejm.org/doi/pdf/10.1056/NEJMoa2035389?articleTools=true
[4] https://www.aerzteblatt.de/archiv/221054/Fake-News-in-der-Medizin-Relatives-Risiko
[6] https://www.nejm.org/doi/full/10.1056/NEJMoa2118542
[7] https://www.katischepis.ch/post/corona-höchste-zeit-für-eine-second-opinion
[10] https://www.katischepis.ch/post/wer-lässt-den-elefanten-endlich-frei
[11] https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124
[12] https://www.infosperber.ch/gesundheit/die-krebsforschung-ist-in-erklaerungsnot/