Scientist and researcher in the German drug approval department: the truth is upside down

Scientist and researcher in the German drug approval department: the truth is upside down

Almost ten months ago, during a business meeting lasting several days in the “Smoking Lounge” of the hotel where we were staying, the head of the medical department of my former employer asked me to talk about my published critical articles on the subject of “Corona” and in particular the COVID – to speak «vaccines». My behavior was classified as “problematic” because I dared to publicly question the work of health authorities and thus important “stakeholders”. Based on facts, I tried to explain how I arrived at my critical attitude. In vain. This was the last conversation. Shortly thereafter, I decided to hand in my resignation. Co-workers had anonymously complained to management about my items. This was in a company that had an “I” for “Integrity” in the official company values ​​that were worked out at great expense by a marketing agency and that all employees should live by. To this day I have never regretted leaving the company. The head of the medical department said goodbye to me neither verbally nor in writing, which says a lot about the humanity that has been completely lost in the last two years.

As a scientist who worked for over 12 years, first in drug approval and then in the medical department of a global pharmaceutical company, I assumed that all of my work colleagues, who were also scientifically trained, were able to interpret studies. Early on, I tried to seek discussion and show that the efficacy endpoints defined in the approval studies of the COVID “vaccines” were not clinically relevant because they only recorded minor events. After the results of the approval studies were published, I shared the opinion of 100,000 other doctors and scientists that these “vaccines” had shown absolutely nothing. I was amazed to find 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 almost froze like in a zoom meeting when the internet connection was lost.

There was then a lively public debate as to whether it was “ok” to show the effectiveness of COVID “vaccines” based on the Relative Risk Reduction (RRR) or whether this should not be better done based on the Absolute Risk Reduction (ARR). Official experts, who of course are only chosen as such if they represent the opinion of the health authorities, were of the opinion that it was obviously “correct” to communicate the effectiveness of the COVID “vaccines” based on the relative risk reduction, since this for Vaccines have always been done that way. [1] Is this enough for an explanation? Probably not.

Science is a “search for truth”

Science is, ideally, a “search for the truth”: to find out whether a method works or not. To do this, the right questions must be asked, the right test conditions selected and the test carried out correctly.

Usually, the effectiveness of a drug is examined in a prospective study in two groups: one group receives the drug to be examined, the other group an established comparative drug or placebo. Over a certain period of time, usually at least 1 year, it is then observed how many cases of a disease against which the new drug is said to be effective (“endpoint events”) are counted in the two groups. If significantly fewer cases of illness occur in the group in which the new drug is administered than in the comparison group, it is classified as effective. Of course, a large number of cases of illness must occur in the study overall. 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 with a relevant frequency, and on the other hand, because a sufficiently large statistical difference must be shown between the two groups in order to obtain approval. Clean science is simple and easy for anyone with common sense to understand.

Efficacy based on RRR without specifying the number of cases: “fake news”?

With the Pfizer “vaccine”, a total of 42,000 study participants in the vaccine group 8 and in the placebo group 162 “confirmed COVID diseases”, which were trivial events such as headache, sore throat, fever, etc. in combination with a positive PCR test was recorded [2] . The case numbers in the approval studies of the Moderna “vaccine” were in a similar range. [3]

In relation to the more than 42,000 study participants, cases of illness occurred in 0.04% in the vaccine group and 0.74% in the placebo group, i.e. in both groups, despite the “pandemic, hardly anyone. As a result, the ARR was 0.74%-0.04%=0.7% and was therefore devastatingly small or the derived benefits for minor events de facto non-existent.

Severe COVID-19 diseases occurred (at the earliest 7 days after the 2nd dose, as previously defined in the study protocol) in only 4 cases among the 42,000 study participants: 3 cases were in the placebo group, 1 case in the vaccine group group recorded. Based on these case numbers, which were in the range of statistical chance, an effectiveness of 66.4% was given in the information for healthcare professionals from December 2020.

If the case numbers were 3 versus 0, an effectiveness of 100% could even be proclaimed based on the RRR. Isn’t this a bit very unscientific and misleading? I personally find few arguments to answer the question with «No». On the contrary: as was also questioned in a comment in Deutsches Ärzteblatt 2021, one should not have an effectiveness that is calculated based on the RRR and announced without the underlying case numbers if these case numbers are in the range of statistical chance classify as «fake news»? [4]

In the meantime, the RRR game seems to be going on happily: On June 15, 2022, Swissmedic announced that with Pavloxid® they had approved another drug for the treatment of COVID-19 for a limited period [5]. In the underlying approval study, an efficacy of 89% was calculated in risk patients who had taken the drug within three days after the onset of the first symptoms compared to placebo for COVID hospitalizations and deaths based on the RRR: In the Pavloxid® group, 0.77% (3 of 389) of the study participants and in the placebo group 7.01% (27 of 385 patients) were hospitalized with a positive PCR test. The ARR was thus 6.2%. The observation period was just 28 days [6]. While only unvaccinated people were included in the study (a previous COVID vaccination was an exclusion criterion), the drug is now to be used in all risk patients. Global data has long shown that vaccinated people are much more susceptible to COVID diseases, severe courses and deaths [7]. The study was therefore carried out in a non-representative, presumably much healthier population. In the USA, it has been apparent since the end of May 2022 that patients who have taken Pavloxid® are increasingly reporting a “rebound phenomenon”, the occurrence of renewed symptoms after the end of therapy. [8th]

Since serious deficiencies have now come to light in the approval dates for the prematurely approved COVID “vaccines” [9][10], healthy caution is probably also appropriate when it comes to COVID “therapies”.

How reliable are published study results?

As early as 2005, Prof. John Ioannidis denounced that most of the published study results were wrong and not reproducible [11]. In a two-million-dollar, eight-year project, researchers tried to replicate as accurately as possible important experiments from basic cancer research that had been described in renowned scientific journals such as “Nature”, “Cell”, “Science”. and confirm the results. However, only 54 of 112 results were the same as in the original test. The majority of the experiments checked could not be confirmed, or the result differed significantly from that of the original experiment: the effect was 85 percent smaller on average when it was repeated. [12]

Science versus “scientism”

Normally, science thrives on a lively discourse: published results are questioned and lively discussed in the professional world. In the last two years it has become very quiet. Published data, no matter how solid or not, is placed on a golden pedestal as an absolute, untouchable truth and revered as an “icon of sacred science in Corona times”.

Science undoubtedly took on the character of a religion during the “Corona times”. Anyone who doubts, no matter how well founded, is portrayed as a heretic. Wasn’t it always 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 questioners and naysayers and, if possible, exclude them from society. Questioners are almost presented as radicalized “sect members” who have strayed from the right path of the “one and only Corona truth”. Only: who is the actually dangerous “sect” here?

We all know that we live in a time where truth is turned upside down, where facts are twisted and evil is presented as good.

Saying “no” and questioning is not an easy exercise. Many who have done so in the last two years have lost something, some even a lot. But many have also gained a lot of new things. Every questioner and naysayer who has set an example in their 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 didn’t just blindly follow the crowd, but rather showed strength and stood up for the truth?

I would like to encourage everyone to continue to do this, according to their abilities, undeterred!












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