Posted 4/17/2021 15:44 (#8957073 - in reply to #8957053) Subject: Merck
Merck didn't want to do the trials. Hmmmmm. Wonder why?***** ----------------- Page 35
. Since the clinical results84) in South Florida, USA mentioned above were excellent, and it was thought to be necessary to obtain approval of ivermectin as an indication for COVID-19, it was decided to conduct a doctor-initiated phase 2 clinical trial. In Japan, MSD Co. Ltd., a subsidiary of Merck & Co., Inc. of the United States, is the sole manufacturer and distributor of ivermectin. The company has marketed 3 mg tablets, under the trade name of “Stromectol®”, since 2002 for the treatment of a rare disease, strongyloidiasis. The sale of Stromectol® was transferred to Maruho Co., Ltd. in the April of 2006, and an additional indication for scabies was approved in August of that same year. MSD Co., Ltd. might have been the best entity to conduct the phase 2 clinical trial aimed at expanding the indication of ivermectin to COVID-19. However, it was reported that Merck & Co., Inc. of the United States had no intention of conducting clinical trials aimed at expanding new indications for ivermectin. It should also be noted that ivermectin has also been sold for more than 30 years with multiple generic products available on the market. At that time, the company was also developing two types of vaccines (V590 and V591) and two therapeutic agents (MK-4482 and MK-7110) against COVID-19. Therefore, in the doctor-initiated phase 2 clinical trial by Kitasato University, “Stromector®” used for the trial was purchased from Maruho Co., Ltd., and the cost of the clinical trial is covered by the research funding raised by donations collected by the “COVID-19 Countermeasure Kitasato Project”. A fund for “Ivermectin for COVID19 (Principal Investigator: Kunihiro Yamaoka)” by the Japan Agency for Medical Research and Development (AMED) adopted an open call for participants of the “Research Program on Emerging and Re-emerging Infectious Diseases; Development of Therapeutic Drugs for Novel Coronavirus Infection (COVID-19)”. Unlike clinical trials conducted by pharmaceutical companies, even if the clinical trial is successful and the indication expanded, there is no benefit to be obtained from the results. As such, the recovery of clinical trial costs is not a consideration at all.