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POINT.
■A series of papers have been published showing that ivermectin is effective in both the prevention and treatment of new coronas, but its use is not progressing in Japan, which is already considered a "country of use.
However, the lack of ivermectin and the fact that ivermectin is not covered by the government's Adverse Effects Relief Program are among the issues that need to be addressed.
If the Japanese version of EUA can be quickly developed and made available to doctors in the field, it will be possible to administer the drug to patients who are waiting at home or receiving medical treatment. The government should actively promote its use.
The delta strain, which originated in India, raged during the Tokyo Olympics, and the number of infected people continues to grow. Why doesn't Japan try to use ivermectin, which has few reported side effects and has been shown to be effective in clinical trials in other countries? On August 5, we conducted an urgent interview with Dr. Ozaki, chairman of the Tokyo Medical Association, who has been an early proponent of ivermectin's effective use.
(Interviewer, Chairman of the Board of Directors of the 21st Century Vision Research Institute, a certified non-profit organization)
Science Journalist Rensei Baba
Peak of Infection Spread Still Unseen
--The explosive spread of the disease, which is also known as the fifth wave, seems to be still on a steady rise. How is the Tokyo Medical Association responding to the rapid increase in the number of people staying at home or receiving medical treatment?
When the number of people waiting at home or receiving medical treatment surged in the third wave in January, we decided that this was not good enough, and the Tokyo Metropolitan Government and the Tokyo Medical Association worked together to build a system with the goal of providing 24-hour support. Of the 47 district medical associations, up to 37 were able to respond. However, the current situation, in which more than 1,000 home care patients are piling up every day, is beyond the limit. Doctors at the clinics are unable to handle general medical care, vaccinations, health checkups, and house calls. Now, public health centers are coordinating hospitalization. The Tokyo Metropolitan Government also has a hospitalization coordination center, but it has not yet reached the point where a system has been established to quickly accept and treat patients with sudden corona changes."
Many clinical trials show "effectiveness in both prevention and treatment
--A review of clinical trial papers on ivermectin published around the world to date shows many examples of ivermectin's effectiveness in both prevention and treatment.
I am aware that there are many papers showing that ivermectin is effective in the prevention and treatment of coronas, especially in Latin America and Asia. We are forced to deal with patients who develop the disease one after another, but there is no effective treatment. There is no vaccine in time. In such an urgent situation, it is natural for clinicians to try to use ivermectin because it has been reported to be effective against coronas. That is the circumstance that led to a number of physician-initiated clinical trial papers."
Ivermectin
--Ivermectin has been used by the World Health Organization (World Health Organization) as a specific treatment for onchocerciasis (river blindness), lymphatic filariasis, and other tropical diseases. The WHO and other countries around the world approved the drug more than 20 years ago. So if it is effective against the new coronas, it is off-label, but the decision to use it in the midst of a pandemic was unavoidable.
That is right. The medical field in a pandemic is a battlefield. It is the same as a field hospital. Patients are brought in, their conditions deteriorate, and they die one after another. At that time, many papers appeared showing that the drug had almost no side effects and was effective against coronas, so I can understand why doctors were clinging to it and administering it.
Just recently, the All India Institute of Medical Sciences (All India Institute of Medical Sciences/ (AIIMS) research group has published a paper examining the preventive effects of ivermectin. According to the study, approximately 3,900 health care workers (staff and students) received ivermectin at a dose of 0.5 mg/kg body weight. The results of the clinical trial showed that ivermectin Those who received two doses had an 83% reduction in new corona infections. The paper was published by one of the world's premier research groups, so it is highly credible."
Japan is already classified as a user country
--Japan notified on May 18, 2020 that the " Guidance for the treatment of new coronavirus infection (COVID-19) From the "Second Edition", ivermectin is used to treat COVID-1 9 treatment is approved for use. Worldwide, Japan is also classified as a country where ivermectin is used.
In Japan, ivermectin has long been approved for the treatment of skin diseases such as scabies under the trade name Stromectol, and the revised guidance notifies that it is also approved for the treatment of new coronas as an "off-label" drug. Off-label means that it may be used at the discretion of the physician and patient. By the time the notification was issued, 36 clinical trials had been conducted in 27 countries around the world, reporting that ivermectin was effective in prevention and treatment. That is why the Ministry of Health, Labor and Welfare approved the off-label use. If it had been shown to be ineffective, they wouldn't have issued the notice."
The government's Diet defense is positive about its use, but...
--Even in the Diet, the government has been making statements that promote the use of ivermectin.
At a February 17 meeting of the House of Representatives Budget Committee, Katsuhito Nakajima, a member of the Democratic Party of Japan's Constitutional Democratic Party, stated, "The government should provide maximum support for clinical trials on ivermectin so that it can be approved as a treatment for coronas as soon as possible. The proposal was made. Minister of Health, Labor and Welfare Tamura said, 'It can still be used for off-label use. There is also the use of taking it at a medical institution and waiting at home,' he replied. Prime Minister Kan responded, "I believe that this is an extremely important drug for Japan, so we will make our utmost efforts," a statement that seemed to indicate a proactive approach. In reality, however, no efforts have been made.
--why can't it be done?
We also looked into the supply chain of Merck & Co. in the U.S., which is the supplier of the approved drugs in Japan and beyond. Merck, perhaps because it is developing a therapeutic drug, is of the opinion that ivermectin is not effective in the treatment or prevention of new coronas, and is working against the use of ivermectin for anything other than skin diseases such as scabies. In other words, even if it is used for new coronas, it will not actually lead to a domestic supply of ivermectin if Merck does not supply it. Even if a doctor writes a prescription for ivermectin, the pharmacy does not have the drug. This effectively makes it unusable."
But since (Merck) says ivermectin doesn't work, there should be no need to restrict the supply of anything." If it doesn't work, there is no demand for it. It would appear that they are blocking supply because they believe it works."
Generics are also not widely used because
--Generic ivermectin drugs are also manufactured in large quantities in China, India, and other countries. If Merck won't supply them, there must be a way to import them and supply them.
Yes, there is. If the "Bill on Special Measures Concerning Designation and Use of Specified Drugs for Treatment of New Strains of Influenza, etc." (Japanese version of the EUA* development bill), which was submitted to the House of Representatives by Representative Nakajima, who is also a doctor, is approved, generic drugs will also be available. The new system will be available in Japan. However, at this point, I believe the government is not moving at all.
Another problem is that ivermectin is already being used in many countries around the world, and its dosage and administration, safety and efficacy have been confirmed, but this is not the case in Japan, where it is still in the clinical trial stage. For this reason, ivermectin is not covered by the system for relief of damage caused by adverse drug reactions. This makes it difficult for doctors to use it. However, despite such uncertainty and disadvantageous circumstances, some physicians who are convinced of ivermectin's effectiveness are prescribing it on their own responsibility. I hope that the Japanese version of the EUA development law will be enacted soon."
EUA (Emergency) Use Authorization The U.S. Food and Drug Administration's (FDA) system for authorizing the use of unapproved drugs and expanding the indications for approved drugs in emergency situations. (1) the disease is life-threatening, (2) the product is recognized as having a certain level of efficacy in treating the disease, (3) the benefits of use outweigh the potential risks of the product, (4) there is no other means of diagnosing, preventing, or treating the disease, or The use of the product is allowed when it is determined that the following conditions are met: there are no suitable alternatives to treat or cure the disease.
Countries where it is used, but in reality it is not available.
Chairman Ozaki (right) is interviewed by the author.
--Since you have approved off-label use of ivermectin, Japan is classified as a "ivermectin-using country" in the world, but in reality, it cannot be used, isn't that right?
That is correct. In short, the government has not established a system for supplying ivermectin, and there is no system in place to promote ivermectin. If the Japanese version of EUA could be established quickly, and if doctors in the field could use it, as Minister Tamura stated in the Diet, it would be possible to administer ivermectin to patients who are waiting at home or receiving medical care, but the current system is virtually useless. It is not possible to do so. They often say, 'For the safety of the people,' but if they remain cautious even in such an emergency situation, we can only understand that they are sacrificing the safety of the people.
Academic sites and researchers who do not take action on their own
--Are there any other problems in Japan?
Ivermectin was discovered by Dr. Satoshi Omura, who even won the Nobel Prize. Japan should be the first country in the world to tackle the question of whether or not ivermectin is really effective against coronas. The NIH continues to take the view that the effect of ivermectin on coronas has not yet been confirmed, but since ivermectin is being used so widely around the world in the midst of a pandemic, the government should conduct clinical trials to obtain scientific evidence (proof). If we can take the initiative and show objective and convincing conclusions, it will help raise the level of research in Japan.
A group of clinical doctors in the U.S. (FLCCC) published results showing that ivermectin is effective against coronas in South America, Asia, and other regions, and the U.K.'s Ivermectin is recommended by BIRD and other physician groups around the world based on a comprehensive meta-analysis of many articles. The company is also working to improve the quality of its products and services. We have also told the Japanese Olympic Committee that ivermectin should be used effectively for the Tokyo Olympics, but the government has taken no action.
There is also a problem with researchers and university professors in the academic field," he said. Many of them do nothing themselves, but take the view of international organizations such as the WHO or large Western health organizations that 'it is undetermined whether ivermectin works for coronas' as their own view. They are working only on the opinions of others, not on their own initiative. Why aren't they willing to find out for themselves whether ivermectin works or not? It is lamentable that there are critics, researchers, and academics who only criticize without doing anything. I wish Japanese academia would contribute more actively."
Metropolitan Medical Association "wants to work on use."
--A clinical trial led by major pharmaceutical company Kowa (Kowa) is finally scheduled in Japan. How do you plan to respond?
Tokyo Governor Yuriko Koike (left) and Chairman Ozaki (right) interviewing the press after a meeting to exchange opinions on the development of a vaccination system in January 2021.
Both the Tokyo Metropolitan Government and the medical associations intend to actively support and cooperate in this clinical trial. We have decided to actively search for and provide medical institutions and other organizations that will cooperate with us. There is no way for a country to rely on vaccines and therapeutic drugs developed by foreign countries. What we need to do is to provide proper data on ivermectin ourselves and aim to contribute to the reduction of severe cases and deaths as a Japan-originated effort.
--What should the Japanese healthcare system learn from the experience of the Corona pandemic?
It has become clear that Japan's universal health insurance system is not equipped to respond to a pandemic contingency such as the one that occurred this time. Private medical facilities are managed by increasing their efficiency by raising their occupancy rates as much as possible. Under such circumstances, it is extremely difficult to respond to a sudden increase in the number of infected patients, as was the case this time.
"One example of a countermeasure is to build a hospital with about 1,000 beds available at public medical institutions and hospitals and operate it normally as a research facility and as a training and training institute for doctors, nurses, and technicians. In the event of a pandemic, it could be used as a medical institution. The idea is to train personnel by honing their skills, and to establish a system in which the trained personnel can be deployed in the event of a pandemic. I think there are issues that need to be addressed before we can put this into practice, but I think it is something that should be studied and researched in the future.
After the interview
Some pushback against WHO's cautious use
With the delta strain (Indian mutant) about to replace almost all of Japan's infected population, the number of new cases of new coronas is reaching record highs on a daily basis.
The number of people treated at home in Tokyo has exceeded 20,000, and the number nationwide is over 70,000. Katsuhito Nakajima, a member of the House of Representatives who is also a doctor, said, "Antibody cocktail therapy is effective, but there are problems in securing the right amount of antibodies and improving the system. It is necessary to expand early treatment options to prevent severe cases of coronas," he emphasized. I felt that one of these options is the administration of ivermectin - which is a strong motivating factor for Chairman Ozaki.
Dr. Tedros, Director-General of WHO
The evaluation of ivermectin for coronary treatment and prevention has not yet been solidified, and major global health organizations, including the WHO and NIH, are "not He maintains that "there are no clinical trial results that show enough evidence to convince the world's scientists. However, it is also true that a number of physician groups in the U.S. and U.K. have come out to refute these claims, saying that there is little evidence to support them.
While some people become seriously ill and even die, doctors around the world are working hard day and night in the medical field to provide treatment. During the period of rapid spread of the disease, the medical field in India was a veritable battlefield. In the absence of sufficient drugs and equipment, ivermectin was administered in many cases, relying on numerous papers showing that it was effective against the new strain of corona, and it was highly effective.
The Indian Bar Association drafted a document heavily criticizing the WHO's decision not to recommend ivermectin for therapeutic use as "tantamount to murder, leaving patients to die," and sent it to Director General Tedros and Chief Scientist The document is being made public to the world.
The FLCCC in the U.S. and the U.K.-based The FLCCC is the world's conducted by 613 scientists (physicians and researchers) on 26,398 A meta-analysis of 63 clinical trials (as of August 15) summarized the results and determined the following
o 86% prevention efficacy in 14 prevention trials.
73% improvement in 27 early symptom treatment trials
40% improvement in 22 trials for the treatment of severe disease
61% reduction in mortality in 25 clinical trials
About half (31) of the meta-analyses were randomized controlled trials (RCTs), which are considered the global standard for clinical trials, and where evidence is important. A 60% improvement has been achieved. Chairman Ozaki is of the opinion that it is not surprising that some clinicians believe this and are willing to use ivermectin for treatment.
There are also persistent arguments against ivermectin.
On the other hand, it is true that there are persistent voices that question or oppose the use of ivermectin for corona treatment and prevention. The author has read three papers claiming no ivermectin effect, two of which were pointed out by researchers as errors in the clinical trial methodology. Other than that, there are no other papers that claim no effect.
Indeed, there was a case in which a paper by a group of Egyptian doctors who claimed that ivermectin was effective was retracted after it was pointed out that the data were suspected of being fabricated and falsified. However, as mentioned above, the fact remains that the number of papers claiming that ivermectin is effective against new-type coronas is overwhelmingly large. Ivermectin has few side effects, is widely available in generic form, and is inexpensive. The idea of using it is not reckless. To deny its use may be to destroy measures to deal with a pandemic.
Expectations for Passage of Japanese EUA Bill
Minister of Health, Labor, and Welfare Tamura told the Diet, "It can still be used for off-label use. There is also the use of taking (ivermectin) at a medical institution and waiting at home," he stated. If this were easy to do, there would be no need for the Tokyo Medical Association to go to the trouble of insisting that ivermectin should be used.
Chairman Ozaki said, "With off-label use, even if there are side effects or other health problems, they are not covered by the relief system, and first of all, there is no product to prescribe. Unless a generic formulation becomes available, ivermectin will, in reality, remain "an ever-unavailable drug.
The barrier to this is the passage of the "Japanese EUA Improvement Bill" submitted to the Diet by Katsuhito Nakajima, a member of the House of Representatives of the Constitutional Democratic Party of Japan, who is also a doctor, and others. However, it is currently on the shelf due to a recess in the Diet.
The bill will solve everything if it is enacted," said Representative Nakajima, who was the lead proponent of the bill. Ivermectin, a drug used to treat scabies, will be able to be used to treat coronas, the use of generic preparations will be paved the way, and adverse reactions and other health problems can be remedied. He believes that this will encourage doctors to prescribe it more aggressively.
The vaccination rate for the Japanese population as a whole is about 50% for the first dose and still less than 40% for the second dose. The greatest concern of Dr. Ozaki, chairman of the Tokyo Medical Association, which serves the largest regional population in Japan, is the tightening of medical facilities to receive severely ill patients and measures to cope with the sudden change in the condition of those who are recovering at home due to severe illness. Dr. Ozaki's words were filled with a sense of urgency that the only way to deal with the situation is to make ivermectin available on an emergency basis.
Ivermectin, discovered in Japan, has the potential to be the "savior" of the Corona pandemic. The clinical trial reports from around the world so far show that it is impossible for it to be totally ineffective. Many countries, including India, have a track record of emergency administration of ivermectin to control the spread of infection. There is no reason to hesitate to use ivermectin for coronary infections in an emergency situation. I am convinced that the use of ivermectin is not a "gamble.
Profiles
Haruo Ozaki
Director, Ozaki Internal Medicine and Cardiology Clinic. He has been particularly focused on tobacco control, which is effective in disease prevention, and frailty control, which prevents the need for nursing care. As chairman of the Tokyo Metropolitan Medical Association, he continues to make requests and proposals to the government, the Tokyo Metropolitan Government, and medical institutions regarding measures against new coronas. He is 69 years old and a graduate of Juntendo University.
Profile
Rensei Baba
Born in 1940. After working in the Yomiuri Shimbun's Social Affairs Department, Science Department, and Commentary Department, he became an editorial writer. After retiring from the Yomiuri Shimbun, he served as a professor at the Tokyo University of Science's Graduate School of Intellectual Property, a visiting professor at Waseda University, a visiting researcher at the Ministry of Education, Culture, Sports, Science and Technology's Science and Technology Policy Research Institute, and a member of the Council for Science and Technology Policy, Cabinet Office. Currently, he is President of the 21st Century Vision Research Association, a certified non-profit organization. He is the author of "Are you alright? Japanese Manufacturing" (President, Inc.), "Are you alright? (Chuokoron Shinsha), "Intellectual Property Nation in Danger" (co-authored), and many other books.
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