TOKYO — As President Trump was extolling the promise of a malaria drug within the determined hunt for coronavirus therapies, one among his prime world allies was promoting the world on his personal “trump card,” a pale yellow tablet that he mentioned may very well be essential to preventing the pandemic.
This supposed beacon of hope is an antiviral medication often called Avigan, and its most vocal proponent is Japan’s prime minister, Shinzo Abe.
Mr. Abe has pushed the homegrown drug in information conferences and in conferences with world leaders, together with a call with Mr. Trump and the opposite heads of the Group of seven. He has allotted practically $130 million to triple an present stockpile of the remedy. And he has supplied to offer it free to dozens of different nations.
The prime minister, nonetheless, has glossed over one essential reality: There isn’t any strong proof that Avigan is definitely efficient in opposition to Covid-19. Whereas the drug has proven potential for treating some lethal illnesses like Ebola in animal research, there are restricted findings that it really works for any sickness.
What Avigan, whose generic title is favipiravir, does have is a peculiar regulatory historical past and one harmful potential aspect impact — start defects. Mr. Abe himself famous in a information convention on Monday that the aspect impact was “the identical as thalidomide,” which precipitated deformities in thousands of babies in the 1950s and ’60s.
At the same time, Mr. Abe called for Avigan to be approved for use against Covid-19 by the end of the month. His pitches for the medication, like Mr. Trump’s testimonials for the antimalarial medicine hydroxychloroquine, are adding to concerns that national leaders could warp careful drug approval processes by making unusual interventions in support of unproven medications.
The prime minister’s boosterism has helped get Avigan into over 1,000 medical facilities in Japan, and the country’s foreign ministry says nearly 80 countries have requested the drug.
“We’re all impatient. We want a drug yesterday,” said Susan Ellenberg, a professor at the University of Pennsylvania who specializes in designing clinical trials. “But we’re not going to know what works until we do these studies.”
As the world clamors for coronavirus treatments, doctors are testing an array of medications. A number of countries, including the United States, have planned or started trials of Avigan.
For political leaders, backing the right treatment could save lives, bolster political fortunes, win international prestige and supercharge corporate profits. Promoting the wrong drug, however, can be disastrous.
The Food and Drug Administration last week warned that hydroxychloroquine and a related drug, chloroquine, can have dangerous effects on heart rhythm. In one extreme example, a man in Arizona died after ingesting a fish tank additive that had the same active ingredient as chloroquine.
Doubts among medical watchdogs have not slowed Avigan’s rise. The drug has the backing of one of Japan’s most powerful companies, Fujifilm, whose subsidiary Toyama Chemical developed Avigan. The Chinese language authorities has attested to its security and effectiveness in opposition to Covid-19.
On Japanese tv, medical doctors are calling the tablet a doable world savior, and celebrities who’ve taken it have supplied glowing testimonials.
However that proof is completely anecdotal, mentioned Masaya Yamato, chief of infectious illnesses at Rinku Common Medical Heart in Osaka, who served on a 2016 authorities panel that thought of the drug as a final line of protection in opposition to new forms of influenza.
“I’m not saying this medication doesn’t work. I’m saying there’s nonetheless no proof that it really works,” Dr. Yamato mentioned.
A spokeswoman for Fujifilm, Kana Matsumoto, mentioned that the corporate was conducting medical trials in Japan and the US “to be able to acquire substantial proof of the drug’s efficacy” in opposition to Covid-19.
Avigan is doubtlessly invaluable as a result of it features in another way from most different antivirals, interfering with viruses’ replica, as an alternative of stopping them from getting into cells. In research on animals, the drug has appeared able to curbing the propagation of sure viruses like Ebola, particularly when administered early.
The drug additionally has main issues. Proof of start defects in animal trials led Japan to place unusually strict controls on the tablet’s use and manufacturing. Earlier than the coronavirus, it had been given to people solely throughout medical trials and in desperate attempts to deal with Ebola. None of these efforts delivered definitive proof that it successfully treats any illness in people, even widespread forms of influenza, Dr. Yamato mentioned.
If Avigan works in opposition to Covid-19, it’s almost certainly helpful within the sickness’s early levels, mentioned Norio Sugaya, an infectious illnesses professional at Keiyu Hospital in Yokohama.
Dr. Sugaya mentioned he believed the drug may very well be helpful as a prophylactic if mixed with widespread testing, a softening of the views he shared with the federal government process power in 2016, when he argued that the drug was unproven and shouldn’t be stockpiled.
Regardless of the warnings, officers on the time determined to buy sufficient tablets for 2 million sufferers, a stockpile that’s now being tapped. To this point, 1,100 Japanese medical services have given Avigan to nearly 2,200 Covid-19 sufferers, with greater than a thousand on wait lists for the drug, government data showed.
A lot of these services aren’t making use of rigorous scientific controls, equivalent to double-blinding and using placebos. They argue that the potential advantages outweigh the dangers, notably within the aged, for whom the issue of start defects is unlikely to be a difficulty.
Fujifilm and others are actually conducting correct trials of the drug for Covid-19. However Mr. Abe has rushed forward of that course of by calling for Avigan’s use to be expanded even additional, by urging hospitals to present it to anybody who desires it, and by telling sufferers to ask for it by title.
On Monday, he mentioned that the approval course of would most likely not rely upon conventional medical trials carried out by the developer, however as an alternative would almost certainly take a “completely different type” after specialists made a judgment in regards to the drug’s effectiveness.
It isn’t clear why he has been such a vocal advocate. Some Japanese media have famous his shut ties to Fujifilm’s chief government, Shigetaka Komori. The 2 males have usually golfed and eaten collectively, last meeting on Jan. 17, in line with the prime minister’s schedule.
In mid-February, Fujifilm was the one firm invited to attend a authorities process power assembly on worldwide cooperation in opposition to the virus, in line with supplies from the assembly posted on-line.
Its representatives offered a 27-page PowerPoint presentation noting that the Chinese language authorities was getting ready to approve the remedy to be used on an emergency foundation. The Chinese language patent on Avigan expired final yr, and if Japan dawdled, it may lose a doubtlessly huge marketplace for the medication.
In a news conference on Feb. 29, Mr. Abe mentioned Japan was testing three therapies in opposition to the virus, mentioning solely Avigan by title. The subsequent week, the chief cupboard secretary, Yoshihide Suga, instructed reporters that Mr. Abe’s relationship with Fujifilm’s chief government had “completely no connection” to the prime minister’s views on the tablet.
Authorities officers are considering “it’s a drug that’s made in Japan, so let’s use it if we are able to,” mentioned Dr. Yamato, the infectious illnesses professional.
The Fujifilm spokeswoman mentioned “there has by no means been any favorable remedy” from Mr. Abe or his administration.
The drug gained additional assist in March, when two Chinese language analysis groups posted papers on-line suggesting that it had hastened the restoration of sufferers experiencing gentle to reasonable circumstances of Covid-19.
Chinese language officers, who’ve been stung by criticism that they initially lined up the outbreak, started promoting the findings for instance of the nation’s profitable response to the virus.
However scientists quickly started choosing the papers aside, arguing that they lacked primary scientific controls. Each papers, which had not been peer reviewed, have been revised, their conclusions changing into much less assured.
Nonetheless, China rapidly approved Avigan to be used in opposition to Covid-19. It was the primary time any nation exterior Japan had accepted its use in opposition to any illness.
Japan itself had solely conditionally greenlighted the drug in 2014 beneath what medical watchdogs describe as extremely uncommon circumstances.
Of their evaluation, regulators wrote that Avigan “has not proven effectiveness” in opposition to seasonal influenza and couldn’t be accepted to be used in opposition to it. As an alternative, they’d enable its use in opposition to new or re-emergent strains of influenza, however solely in “disaster” conditions when present antivirals proved ineffective.
Ms. Matsumoto, Fujifilm’s spokeswoman, mentioned that the approval course of was “sturdy and rigorous.”
In a report issued Friday, Medwatcher Japan, a nonprofit group that screens the pharmaceutical trade, described the approval process as “exceedingly irregular.”
“It’s unbelievable that it was ever stockpiled as an influenza drug,” mentioned Masumi Minaguchi, the group’s secretary basic. “And it’s much more unbelievable, that beneath these circumstances, even with none scientific foundation, individuals are being instructed to make use of it.”
Hisako Ueno and Makiko Inoue contributed reporting from Tokyo, and Cao Li from Hong Kong.