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Global trends in clinical studies of ivermectin in covid 19
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John Burns
Posted 4/17/2021 15:24 (#8957053 - in reply to #8955464)
Subject: The meat of the article



Pittsburg, Kansas

Excerpt from page 34 of the article. Really makes me question the morality of the WHO and other organizations of authority. Is it our welfare they are really looking out for? Or something else.
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Regulators claim that “there is not enough evidence to accept it,” but the safety level of ivermectin has already been achieved by means of the MDP granting more than 3 billion doses to individuals over 30 years. They argue that there is no clear or sufficient evidence, and that safety assurance when used with COVID-19 patients is inadequate. This is a situation where ethics should be questioned as to whether it is permissible to ban patients whose lives may be able to be saved by administering ivermectin only because absolute safety is not guaranteed. There is a need to state a legitimate reason as to why there is hesitation to use an already effectively confirmed drug such as ivermectin (based on RWE) in patients with COVID-19 who could possibly even expect to be cured with its use. Regulators argue that existing data on the efficacy of ivermectin for COVID-19 are biased in its study plans and methods, and are insufficient to determine validity. A meta-analysis of 14,906 patients in the 42 clinical trials101) described above has shown sufficient efficacy of ivermectin, with a 1 in 4 trillion chance of the conclusion being a mistake. Yet, it is still considered insufficient evidence. Randomized controlled trials are regarded important by regulators. There are 21 trials employing 2,869 patients out of 42 studies. If regulators argue that studies of this magnitude are inadequate to allow the clinical use of ivermectin in COVID-19, then legitimate and compelling explanations for such judgements should be required. Both the meta-analysis of 15 clinical studies by Lawrie103) of the United Kingdom (who is a consultant for WHO clinical trials) and that of 18 clinical studies102) conducted by Hill (who is also a consultant of the WHO) in collaboration with 40 researchers from 13 countries have been carried out. Such analyses have affirmed the effectiveness of ivermectin for COVID-19, after fully analyzing for the bias of beliefs (that ivermectin was effective or that the placebo was ineffective). However, the results of such a meta-analysis are rated as “insufficient data” and “very low certainty” by the panels of the NIH and the IDSA Clinical Evaluation Guidelines Committee. It is requested that the WHO committee responds to the recommendations made by the BIRD team151) submitted at the end of February. Furthermore, the recommendations were also sent to the NIH and the CDC, and it will be noted whether there is a difference in the correspondence between the two. In addition, on the 19th of February, the WHO Working Group was hearing the results of a survey on the rapid decrease in excess mortality and the rapid increase after discontinuation of the mass distribution of ivermectin in Peru134). There is also a lot of interest in how the WHO handles such real-world evidence in real time. 




Edited by John Burns 4/17/2021 15:25
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