Fumiyasu Akegawa – Chair & CEO DEVNET INTERNATIONAL
On December 1st, Japan’s Aichi Prefecture announced that it would cooperate with the pharmaceutical manufacturer Kowa Co, Ltd. to carry out the clinical trial to confirm the therapeutic effect of ivermectin which is developed by Dr. Satoshi Omura, winner of the 2015 Nobel Prize in physiology or medicine. They started the clinical trial from the same day at an accommodation facility in the city. Ivermectin is a parasitic drug, but reports of dramatic effects on the Covid-19 have come to be a series overseas. I believe it is significantly important for the Japanese government to approve ivermectin as a treatment for Covid-19 infections after this clinical trial is successful, and to disseminate that fact to the world.
WHO (World Health Organization) has published a guideline that “ivermectin only be used to treat Covid-19 within clinical trials” (2021/3/31). However, it is actually used as a therapeutic drug for Covid-19 infections in many countries in regions where vaccine supply has been delayed, such as South Asia, Latin America, and Africa. Many reports of significant reductions in the number of infections and deaths have been reported. In addition, FLCCC (Front Line Covid-19 Critical Care) alliance, a non-profit organization formed by American critical care specialists, considers ivermectin to be an indispensable drug for the treatment of Covid-19 infections, and has published its medication method as a protocol. (https://covid19criticalcare.com/covid-19-protocols/)
In Japan, Kitasato University announced in May 2020 that it aims to obtain approval for ivermectin as a therapeutic drug for the Covid-19. The Japanese government also expressed its intention to support research and clinical trials for practical use, but no application for approval has been submitted yet. Currently, there are only four Covid-19 treatments approved in Japan: remdesivir, dexamethasone, varicinitif, and antibody cocktail therapy. In February 2021, Haruo Ozaki, Chairman of the Tokyo Metropolitan Medical Association, recommended the emergency use of ivermectin, which has been shown to be effective in preventing aggravation overseas, in order to respond to the spread of the Covid-19 infection. However, it remains one of the “therapeutic agents currently under development” in the “Guide for Medical Treatment of Covid-19 Infectious Diseases” (2021/11/2, 6th edition) issued by the Ministry of Health, Labor and Welfare.
In September 2021, Kowa Co., Ltd. released a clinical research implementation plan for 1,000 people with mild symptoms. This corporate clinical trial was realized as a result of Dr. Omura’s direct request to Kowa. MSD, a Japanese subsidiary of Merck & Co., a major US pharmaceutical company that manufactures ivermectin, says that there is no evidence that it is effective against Covid-19 and its safety is unknown. Therefore, it is said that Kowa will be responsible for manufacturing the therapeutic drug after it is put into practical use. Meanwhile, MSD applied to the Ministry of Health, Labor and Welfare on December 3, 2021 for approval to manufacture and sell “molnupiravir,” a drug for treating Covid-19 infections.
Regarding ivermectin, not only the WHO guideline, but also the FDA (US Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) have issued a very negative opinion and a statement to refrain from using it.
In addition, malicious attacks such as those shown in the following articles continue.
(Ivermectin: How false science created a Covid ‘miracle’ drug “BBC News 2021/10/06 https://www.bbc.com/news/health-58170809 ) However, if ivermectin developed by Nobel laureates is officially approved in Japan where the vaccination rate is high, WHO’s policy may be withdrawn. Then, many countries where the use of ivermectin is currently banned will change to allow it.
Now, the world is amid the spread of a new variant, Omicron. And in developed countries including Japan, the necessity of the third vaccination as a measure against Omicron is being appealed. Vaccination alone may not be able to stop the spread of infection. The pandemic may end only when oral drugs like ivermectin are widely available all over the world. To that end, I hope that the ongoing clinical trials will be successful and that the Government of Japan will strongly support the legitimacy of the use of this important therapeutic medicine to the world.