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Abe follows Trump's example, approving drugs quickly after criticism

by Isabel Reynolds

Bloomberg

Prime Minister Shinzo Abe’s government is following the example set by the U.S. in speeding up approval of still unproven virus drugs, as he faces new criticism over his plan for exiting the state of emergency and reviving the nation’s economy.

Japanese regulators are usually known for taking a year to approve new drugs, but authorized the use of Gilead Sciences Inc.’s remdesivir just three days after receiving the application.

Abe has also said that Avigan, Fujifilm Holdings Corp.’s rival anti-viral drug and a treatment he has long cited in public remarks, was in line for clearance by the end of the month.

The accelerated process comes as Abe faces growing dissatisfaction with his efforts to contain the new coronavirus that causes COVID-19, despite a recent decline in new infections.

Japan is only the second country to approve the use of remdesivir after the U.S., which said the drug originally made to treat Ebola could be administered on an emergency basis to hospitalized COVID-19 patients with low blood-oxygen levels or on breathing support.

“He’s been criticized for not being fast enough, so he tried to blunt that argument a little bit,” said Steven Reed, an emeritus professor of political science at Chuo University. “I don’t think it’ll have a serious effect on public opinion, at least until results come in.”

While the nation has, so far, avoided an outbreak on the scale of those in the U.S. and some European countries, the economic impact of the virus has left many businesses reeling. The downturn may count against Abe’s ruling Liberal Democratic Party in a general election that must be held by autumn 2021.

News reports have drawn contrasts with neighbors such as South Korea and Taiwan, highlighting their nimble use of technology and public health measures to bring down new infection numbers to manageable levels.

Abe’s efforts, meanwhile, have been hindered in some cases by reliance on fax machines and antiquated name seals to process official documents.

An opinion survey published Monday by the Nikkei newspaper found that 55 percent now disapproved of the Abe government’s handling of the crisis, compared with 44 percent a month earlier. His decision to send two cloth masks to every household in the country was ridiculed by voters more interested in promised cash handouts that for most have yet to materialize.

The probability of a recession in the next 12 months has risen to 100 percent, according to economists surveyed by Bloomberg earlier this month. Last week Abe extended a national state of emergency to the end of the month, effectively keeping some businesses closed, although less significantly affected regions could see restrictions lifted more quickly.

Many around the world seeking some relief have focused their hopes on remdesivir. Gilead shares surged since 23 percent between January, when China first confirmed human-to-human transmission of the virus, and May 8, compared with a 2.9 percent decline in the Nasdaq over the same period.

The drug’s efficacy is far from certain, with multiple trials still underway. One early analysis of a U.S.-led trial released last month showed that about two-thirds of severe COVID-19 cases improved when treated with remdesivir, a finding top U.S. infectious disease expert Anthony Fauci called “quite good news.”

However, an analysis of a separate Chinese trial prematurely published — and then retracted — by the World Health Organization in April indicated that the drug didn’t show benefits in preventing death or reducing viral load. The study was halted early after the country’s caseload fell and researchers struggled to enroll enough test subjects.

Nonetheless, the U.S. Food and Drug Administration quickly approved the drug for emergency treatments. Japanese regulators then authorized the use of the drug based on the FDA’s approval.

The remdesivir authorization marked only the second time Japan has used its emergency-approval system, the health ministry said. The three-day turnaround compares with an average of almost a year for regular drug approvals in the nation, according to the Pharmaceuticals and Medical Devices Agency.

Abe’s best hope of restoring an economy he long boasted of reviving under his “Abenomics” policy program may be to assuage fear by introducing treatments or vaccines. He is set to lay out plans for a gradual re-opening after his expert panel meets Thursday.

The slow pace of most virus policy measures indicates Japan’s bureaucracy has failed to swing into crisis mode, said Hiroyuki Kishi, a former trade ministry official who’s now a professor at Keio University. The same organizational faults were to blame for the relatively low level of virus testing and the long wait for cash handouts, Kishi said.

“They knew by early March that the situation was serious,” he said. “It was all very leisurely.”

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