Only about 0.5% of the stockpile planned by the countries using "Abigan"

About 10,000 patients were given Avigan, which is under review for approval as a treatment for the new coronavirus, in the year to the end of last month, which is about 0.5% of the government's planned stockpile. I found that I stayed.

Experts familiar with the treatment of infectious diseases point out that it is necessary to reconsider whether to stockpile as planned, citing that the efficacy has not been proven and clinical research is continuing in the background. ..

"Abigan" was developed as a treatment for the new strain of influenza, and in April last year, the government stockpiled 2 million people by the end of this year, saying that it could be expected to have an effect on the new coronavirus, which had a limited treatment at that time. I have put together a plan.

The Ministry of Health, Labor and Welfare plans to purchase 550,000 people from Fujifilm Toyama Chemical in January, and 790,000 people on the 19th, in addition to the approximately 700,000 people already stockpiled.

The total cost is expected to be approximately 13.9 billion yen.

On the other hand, according to Fujita Medical University, which continues observational research on avigan, a total of 10,800 patients were used for patients in the year from February last year to 24th last month, which is planned by the government. It was 0.54% of the stockpile.

Regarding Avigan, in December of last year, an expert group of the Ministry of Health, Labor and Welfare postponed the decision on approval or disapproval, saying that "it is difficult to clearly judge the effectiveness against the new coronavirus with the current data", and it is time to be approved. It does not stand the prospect.

Professor Kazuhiro Tateda of Toho University, who is the chairman of the Japan Society for Infectious Diseases, said, "In April of last year, it was decided that the stockpile would be effective even if it was a little, but clinical research is still ongoing and it is effective. It is necessary to consider whether to stockpile as planned or to stop once. Based on the information obtained so far, it is also possible to utilize other therapeutic agents. It should be considered again including this. "

The Ministry of Health, Labor and Welfare commented, "We have already decided to stockpile 2 million people from the perspective of crisis management. The expiration date is 10 years, so if approved, we would like to use it as a therapeutic drug."

"Abigan" history

Initially, the government was aiming for approval of Avigan by the end of May last year, and Fujifilm Toyama Chemical was conducting clinical trials.

However, the data did not collect as expected, and in July last year, a group such as Fujita Medical University said, "Although there was a tendency for fever to decrease when administered from the first day, statistically clear effectiveness could not be confirmed. "And so on.

In September of last year, Fujifilm Toyama Kagaku conducted a clinical trial using a method of administering avigan or placebo without telling the patient, and confirmed the effect of shortening the period until the PCR test became negative by 2.8 days. In October, we submitted an application for approval to the Ministry of Health, Labor and Welfare.

On the other hand, at the expert group of the Ministry of Health, Labor and Welfare held in December last year, the committee members asked for careful judgment, saying, "The prejudice of the doctor who administered the drug may have an effect." The Ministry of Labor has indicated that it will conduct a new examination based on data from overseas clinical trials.

Doctor in charge of treatment "I rarely use it now"

A doctor in charge of treating inpatients with the new coronavirus at a hospital in the Tokyo metropolitan area said that the target for using Avigan was a patient with relatively mild pneumonia who did not need to be given oxygen. I used to use it in the early days, but I rarely use it now. "

On top of that, "It is not that we are still considering the use of Avigan, but it has not been approved and it has been pointed out that there is a possibility of side effects on the foetation, so the procedure for obtaining the consent of the patient may be complicated. I don't think it is necessary to administer it. In the first place, mildly ill patients often do not need therapeutic drugs, and patients who need oxygen administration should be treated with already approved remdesivir. I have. "

Expert "I can't think of normal procurement"

Hiroshi Arikawa, an alumnus of the Board of Audit, who was in charge of inspections by the former Ministry of Health and Welfare when he was active and is now a visiting professor at Nihon University, said, "Although it is related to the lives and safety of the people, safety and effectiveness are It is unthinkable to stockpile at an unestablished stage if it is a normal procurement. Procurement may be permitted if it is necessary to urgently stockpile and can explain to the public that it cannot be replaced by other medicines. However, if that is not possible, we should stop procuring immediately and reconsider the appropriate purchase time and method. "

Other treatments are also included in the "Clinical Guide"

The Ministry of Health, Labor and Welfare introduces several new coronavirus treatments in addition to Avigan in the "Medical Care Guide" for medical institutions.

One of the representative drugs is "remdesivir", which was approved for the first time in Japan as a therapeutic drug for the new coronavirus in May last year.

This drug was developed as a treatment for Ebola hemorrhagic fever, and is used in principle for critically ill patients with a respirator.

The other is dexamethasone, a steroid that has already been approved as a drug for pneumonia and other drugs, and clinical studies in the United Kingdom have shown that it can reduce the deaths of severely ill people.

Regarding "Abigan", he explained that he is currently applying for approval, and in clinical trials in asymptomatic and mildly ill patients, although there was no significant difference, there was a tendency for PCR tests to become negative at an early stage. I will.