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Editorial: Excessive haste in approving COVID-19 drugs is a no-no

  • May 11, 2020
  • , The Asahi Shimbun , 1:46 p.m.
  • English Press

A number of trials and studies are under way on several drugs that have emerged as candidates in the search for treatments for new coronavirus infections. 

 

Remdesivir, one of those drugs, has been approved with exceptional speed by the health ministry after the United States permitted emergency use on patients in severe conditions.

 

The ministry took the unusual procedure under a special framework that allows domestic screening processes to be simplified.

 

There are, of course, concerns about possible side effects. There should be a follow-up study on all patients to whom the drug is administered, and its effectiveness should be carefully reviewed.

 

Many people have expressed hopes for the early development of COVID-19 therapeutic drugs. Concerned parties should do their best to meet those expectations.

That does not mean, however, that procedures for verifying drug efficacy and safety can be slighted.

 

Doctors on the front lines have set their sights on Avigan. The drug, which was developed by a Japanese manufacturer, has been approved as a treatment for new types of influenza expected in the future.

 

Clinical tests are continuing for having Avigan also approved as a COVID-19 treatment. At the same time, patients are taking the medicine in medical research (clinical studies) in which many health care institutions are participating.

 

Prime Minister Shinzo Abe said during a news conference on May 4 that he hopes to have Avigan approved as a COVID-19 drug by the end of May.

“It has been administered in nearly 3,000 cases,” he said. “I have been told the drug is turning out to be effective.”

 

During a talk aired May 6 on internet TV, Kyoto University professor Shinya Yamanaka, a Nobel Prize-winning stem cell biologist, asked Abe to help speed the timeline by adding a word from the prime minister to the project.

 

However, excessive haste is a no-no.

 

Many COVID-19 patients have recovered without using Avigan. It will be difficult to determine how effective the medicine is simply based on reports of cases where conditions have improved under the use of Avigan.

 

Efficacy should not be evaluated under the influence of foregone anticipation. It should also be kept in mind that there were reports of serious side effects in experiments on animals.

 

We are reminded of Iressa, a cancer agent that Japan approved in 2002 ahead of the rest of the world.

 

It was initially touted as a new “dream medicine” with few side effects, but no sooner was it released for sale than there were cases of deaths that were likely caused by its side effects.

 

The serious damage arose because Iressa was put to widespread use under insufficient information, including on the types of patients for whom the medicine is effective.

 

Abe has reiterated that anyone will be entitled to take Avigan on request if approval is obtained from the ethics committee of the patient’s hospital. Those remarks, however, could be a source of confusion.

 

Not every hospital will be able to prescribe Avigan. In addition, if patients who are deemed not eligible were to ask for the drug, pinning hopes on Abe’s remarks, that could increase the workload of health care workers who have to deal with such requests.

 

The government has said it will provide Avigan to more than 40 countries free of charge.

 

Its approval process should go through the proper steps without omission because the medicine must not only benefit patients in Japan but also contribute to international cooperation.

 

We should deal appropriately with the coronavirus crisis without forgetting the history of suffering induced by drugs.

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