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Westlake Legal Group > Posts tagged "Trump, Donald J" (Page 34)

A Bitter Battle for a California House Seat Unfolds in Quarantine

Westlake Legal Group 00-CA25-facebookJumbo A Bitter Battle for a California House Seat Unfolds in Quarantine United States Politics and Government Trump, Donald J Smith, Christy Republican Party Hill, Katie (1987- ) Garcia, Mike Elections, House of Representatives Democratic Party Coronavirus (2019-nCoV) California absentee voting

LOS ANGELES — Christy Smith, a Democratic House candidate in suburban Los Angeles, had just finished a debate (over Zoom, of course) and was eager to point something out: First, President Trump had endorsed her Republican opponent, Mike Garcia. Then the president raised the specter of voting fraud, writing on Twitter: “Turn your Ballots in now and track them, watching for dishonesty. Report to Law Enforcement.”

Democrats saw this special election on May 12 as a referendum on Mr. Trump even before the coronavirus crisis brought his leadership front and center for many Americans. For Mr. Garcia, the president’s support means potentially more donors and a motivated, loyal base. For Ms. Smith, it’s a vulnerability to attack.

The same week, we have a president who endorsed both my opponent and potentially using household disinfectants to treat a deadly pandemic,” Ms. Smith said from her home office in a recent interview. “I think that pretty well encapsulates the moment.”

The election is a microcosm of the country’s politics amid the health crisis: It is an early test of Mr. Trump’s sway in a race both he and his former rival, Hillary Clinton, have weighed in on. It is a battle over vote-by-mail in which doubts have been sown over the election’s integrity. And it is showing just how nasty politics can be, even under lockdown.

In the 2018 midterm elections, this Southern California district, the 25th Congressional, was one of the highest-profile victories for Democrats. But after just a year in office, Representative Katie Hill resigned after admitting to an affair with a staff member. Now, Ms. Smith and Mr. Garcia are locked in a bitter battle that will serve as an important early test for both parties ahead of the fall.

One key question is how much of a role Mr. Trump will play. Democrats believe that focusing on his leadership, particularly over the pandemic, will help them in a suburban district north of Los Angeles that Ms. Hill won by nine percentage points. But Republicans appear emboldened, counting on reliable conservatives to cast their ballots.

Each of the roughly 425,000 voters in the district was sent a ballot for the election — with return postage already paid. But there’s another unknowable: How much will it take to get voters to move those ballots from their kitchen counter to their mailbox at a time when many are consumed by worries about their health and finances?

If the choice is between “‘I’ve got to spend a little time thinking about who my congressional candidate is today’ or ‘I’ve got to figure out a way to get back online and apply one more time for my unemployment insurance that I haven’t gotten yet,’” the answer is obvious, Ms. Smith said. “People are going to take care of their families.”

“We get the challenge,” she added. “We understand how hard it is.”

Mr. Garcia, a defense contractor and political newcomer, has relied heavily on his biography — he was raised in the district, leaving after high school for the Navy, where he served as a pilot. Nearly all of his advertisements feature him standing in front of a plane, and his campaign logo is designed to resemble jet wings, with “fighter pilot” above his name on his website.

During a recent call with volunteers, Ms. Smith, a current member of the State Assembly with a long history in politics, laughingly questioned Mr. Garcia’s credentials.

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“Did you guys know he’s a pilot?” she asked sarcastically. During the debate the day before, she said, she texted her team to point out that while he had “pictures of planes behind him,” her background was “constitutional law books.”

Mr. Garcia’s supporters seized on the remarks, saying they were evidence that she does not respect his military service. Mr. Garcia declined to comment for this article.

During the pandemic, the race has become increasingly vitriolic — with the campaigns unable to knock on doors, they have focused on blanketing television and social media with advertisements, many of them negative.

The race is also putting a sharp focus on the increasingly partisan debate over vote-by-mail, which Republicans have portrayed as ripe for fraud, though there is no evidence of widespread wrongdoing. Party officials have focused much of their ire on so-called ballot harvesting, the legal practice in which political organizers collect ballots from voters and drop them off at polling sites on their behalf.

Speaking to supporters in late January, Mr. Garcia said that he believed many votes were left uncounted and that the special election would “magnify or potentially open up the opportunity for more fraud than already existed,” both unfounded claims. Republicans in Congress, including Kevin McCarthy of California, the House minority leader, have repeatedly questioned the results of past elections in the state.

“The question is, how confident am I in the integrity of the election? Not confident at all,” Mr. Garcia said. “The bottom line is, I have very low confidence in a truly high-integrity election process.”

This month, Republican officials in California sent a letter to Gov. Gavin Newsom, a Democrat, demanding that he make such collections illegal amid stay-at-home orders. Last week, state party officials filed a lawsuit to try force such an action.

But while Ms. Smith said she was not allowing anyone from her campaign to collect ballots, Democrats say Mr. Garcia’s campaign appears to be setting up the kind of system his party has repeatedly condemned. Officials from his campaign have encouraged local churches to set up unofficial drop-off sites for ballots as recently as last month, according to an internal email provided by Democratic officials.

Alex Padilla, California’s secretary of state, has not issued any directive over collecting ballots, but has been unabashed in his response to accusations from Republicans that he has presided over elections rife with fraud — a claim he calls baseless.

“Voter fraud is nothing but a distraction and nothing but a pretext for suppressing the vote,” said Mr. Padilla, a Democrat. “It’s disingenuous at a time when we should be making it easier — not stifling rights.”

More than half of all voters in California have voted by mail for the last decade. Mr. Padilla and other election officials view the special election as a test run for November. Though state officials are still hammering out detailed plans, Mr. Padilla expects that voters statewide will automatically receive their ballots by mail.

Even then, local officials will still be expected to open in-person polling places, and they have begun to search for larger locations to allow for social distancing and for new volunteers to work the sites.

“The most important thing is to demonstrate that even during the Covid pandemic, our democracy is resilient, and that we can provide accessible and safe measures both now and especially for November,” Mr. Padilla said.

Early indications suggest voters are turning out in high numbers. Already, nearly 20 percent of voters in the district have cast their ballots, with 31 percent of registered Republicans and 19 percent of Democrats doing so, according to tracking data. Registered Democrats outnumber Republicans by nearly 30,000 voters in the district.

And Mr. Trump is hardly the only high-profile official paying attention to the race: Ms. Smith attracted endorsements from Senators Elizabeth Warren and Kamala Harris, and this week Ms. Hill’s new political action committee began a $200,000 advertising blitz to urge her former supporters to vote in the special election, targeting newly registered voters and those who cast a ballot in 2018 but had not consistently voted in congressional elections.

But many Democrats worry that Ms. Hill’s sudden resignation left the party vulnerable in the district, and strategists have privately reported that Ms. Hill’s high unfavorable ratings in the district have made it more difficult for Ms. Smith. In February, several California lawmakers met at the Democratic Congressional Campaign Committee headquarters and expressed concern that she was not raising the kind of money needed to win the district. Both Ms. Smith and Mr. Garcia have each raised over $2.2 million and have about $300,000 cash on hand, according to their most recent campaign finance reports. Last month, the Cook Political Report shifted the race from “lean Democratic” to a “tossup.”

During the 2018 midterm elections, activists from safe Democratic districts in Los Angeles routinely trekked an hour north to knock on doors in the middle-class district, which has long drawn families looking for more affordable suburban housing and has grown increasingly diverse — roughly 45 percent of the district is black, Latino or Asian.

Indivisible, the liberal group that helped flip several congressional districts in 2018 and has backed Ms. Smith, had so many volunteers for at-home phone banks in recent weeks that it had to create a waiting list and wrote postcards to send to every voter in the district.

“People are really motivated to defend what they won, and there’s definitely still a lot of energy among volunteers,” said Lucy Solomon, a national political director for the group. But she tempered her optimism. “It’s impossible to know how coronavirus is going to affect the outcome,” she said.

Though Mr. Padilla expects that the overwhelming majority of voters will choose to mail in their ballots, a few in-person voting options will be open on May 12, mostly to allow for same-day voter registration.

Still, he cautioned, if the results show a close race, a winner might not be clear for days, or even weeks. And no matter who wins, a rematch is expected in November, when the candidates will battle for the full congressional term.

Catie Edmondson contributed reporting from Washington.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

A Bitter Battle for a California House Seat Unfolds in Quarantine

Westlake Legal Group 00-CA25-facebookJumbo A Bitter Battle for a California House Seat Unfolds in Quarantine United States Politics and Government Trump, Donald J Smith, Christy Republican Party Hill, Katie (1987- ) Garcia, Mike Elections, House of Representatives Democratic Party Coronavirus (2019-nCoV) California absentee voting

LOS ANGELES — Christy Smith, a Democratic House candidate in suburban Los Angeles, had just finished a debate (over Zoom, of course) and was eager to point something out: First, President Trump had endorsed her Republican opponent, Mike Garcia. Then the president raised the specter of voting fraud, writing on Twitter: “Turn your Ballots in now and track them, watching for dishonesty. Report to Law Enforcement.”

Democrats saw this special election on May 12 as a referendum on Mr. Trump even before the coronavirus crisis brought his leadership front and center for many Americans. For Mr. Garcia, the president’s support means potentially more donors and a motivated, loyal base. For Ms. Smith, it’s a vulnerability to attack.

The same week, we have a president who endorsed both my opponent and potentially using household disinfectants to treat a deadly pandemic,” Ms. Smith said from her home office in a recent interview. “I think that pretty well encapsulates the moment.”

The election is a microcosm of the country’s politics amid the health crisis: It is an early test of Mr. Trump’s sway in a race both he and his former rival, Hillary Clinton, have weighed in on. It is a battle over vote-by-mail in which doubts have been sown over the election’s integrity. And it is showing just how nasty politics can be, even under lockdown.

In the 2018 midterm elections, this Southern California district, the 25th Congressional, was one of the highest-profile victories for Democrats. But after just a year in office, Representative Katie Hill resigned after admitting to an affair with a staff member. Now, Ms. Smith and Mr. Garcia are locked in a bitter battle that will serve as an important early test for both parties ahead of the fall.

One key question is how much of a role Mr. Trump will play. Democrats believe that focusing on his leadership, particularly over the pandemic, will help them in a suburban district north of Los Angeles that Ms. Hill won by nine percentage points. But Republicans appear emboldened, counting on reliable conservatives to cast their ballots.

Each of the roughly 425,000 voters in the district was sent a ballot for the election — with return postage already paid. But there’s another unknowable: How much will it take to get voters to move those ballots from their kitchen counter to their mailbox at a time when many are consumed by worries about their health and finances?

If the choice is between “‘I’ve got to spend a little time thinking about who my congressional candidate is today’ or ‘I’ve got to figure out a way to get back online and apply one more time for my unemployment insurance that I haven’t gotten yet,’” the answer is obvious, Ms. Smith said. “People are going to take care of their families.”

“We get the challenge,” she added. “We understand how hard it is.”

Mr. Garcia, a defense contractor and political newcomer, has relied heavily on his biography — he was raised in the district, leaving after high school for the Navy, where he served as a pilot. Nearly all of his advertisements feature him standing in front of a plane, and his campaign logo is designed to resemble jet wings, with “fighter pilot” above his name on his website.

During a recent call with volunteers, Ms. Smith, a current member of the State Assembly with a long history in politics, laughingly questioned Mr. Garcia’s credentials.

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“Did you guys know he’s a pilot?” she asked sarcastically. During the debate the day before, she said, she texted her team to point out that while he had “pictures of planes behind him,” her background was “constitutional law books.”

Mr. Garcia’s supporters seized on the remarks, saying they were evidence that she does not respect his military service. Mr. Garcia declined to comment for this article.

During the pandemic, the race has become increasingly vitriolic — with the campaigns unable to knock on doors, they have focused on blanketing television and social media with advertisements, many of them negative.

The race is also putting a sharp focus on the increasingly partisan debate over vote-by-mail, which Republicans have portrayed as ripe for fraud, though there is no evidence of widespread wrongdoing. Party officials have focused much of their ire on so-called ballot harvesting, the legal practice in which political organizers collect ballots from voters and drop them off at polling sites on their behalf.

Speaking to supporters in late January, Mr. Garcia said that he believed many votes were left uncounted and that the special election would “magnify or potentially open up the opportunity for more fraud than already existed,” both unfounded claims. Republicans in Congress, including Kevin McCarthy of California, the House minority leader, have repeatedly questioned the results of past elections in the state.

“The question is, how confident am I in the integrity of the election? Not confident at all,” Mr. Garcia said. “The bottom line is, I have very low confidence in a truly high-integrity election process.”

This month, Republican officials in California sent a letter to Gov. Gavin Newsom, a Democrat, demanding that he make such collections illegal amid stay-at-home orders. Last week, state party officials filed a lawsuit to try force such an action.

But while Ms. Smith said she was not allowing anyone from her campaign to collect ballots, Democrats say Mr. Garcia’s campaign appears to be setting up the kind of system his party has repeatedly condemned. Officials from his campaign have encouraged local churches to set up unofficial drop-off sites for ballots as recently as last month, according to an internal email provided by Democratic officials.

Alex Padilla, California’s secretary of state, has not issued any directive over collecting ballots, but has been unabashed in his response to accusations from Republicans that he has presided over elections rife with fraud — a claim he calls baseless.

“Voter fraud is nothing but a distraction and nothing but a pretext for suppressing the vote,” said Mr. Padilla, a Democrat. “It’s disingenuous at a time when we should be making it easier — not stifling rights.”

More than half of all voters in California have voted by mail for the last decade. Mr. Padilla and other election officials view the special election as a test run for November. Though state officials are still hammering out detailed plans, Mr. Padilla expects that voters statewide will automatically receive their ballots by mail.

Even then, local officials will still be expected to open in-person polling places, and they have begun to search for larger locations to allow for social distancing and for new volunteers to work the sites.

“The most important thing is to demonstrate that even during the Covid pandemic, our democracy is resilient, and that we can provide accessible and safe measures both now and especially for November,” Mr. Padilla said.

Early indications suggest voters are turning out in high numbers. Already, nearly 20 percent of voters in the district have cast their ballots, with 31 percent of registered Republicans and 19 percent of Democrats doing so, according to tracking data. Registered Democrats outnumber Republicans by nearly 30,000 voters in the district.

And Mr. Trump is hardly the only high-profile official paying attention to the race: Ms. Smith attracted endorsements from Senators Elizabeth Warren and Kamala Harris, and this week Ms. Hill’s new political action committee began a $200,000 advertising blitz to urge her former supporters to vote in the special election, targeting newly registered voters and those who cast a ballot in 2018 but had not consistently voted in congressional elections.

But many Democrats worry that Ms. Hill’s sudden resignation left the party vulnerable in the district, and strategists have privately reported that Ms. Hill’s high unfavorable ratings in the district have made it more difficult for Ms. Smith. In February, several California lawmakers met at the Democratic Congressional Campaign Committee headquarters and expressed concern that she was not raising the kind of money needed to win the district. Both Ms. Smith and Mr. Garcia have each raised over $2.2 million and have about $300,000 cash on hand, according to their most recent campaign finance reports. Last month, the Cook Political Report shifted the race from “lean Democratic” to a “tossup.”

During the 2018 midterm elections, activists from safe Democratic districts in Los Angeles routinely trekked an hour north to knock on doors in the middle-class district, which has long drawn families looking for more affordable suburban housing and has grown increasingly diverse — roughly 45 percent of the district is black, Latino or Asian.

Indivisible, the liberal group that helped flip several congressional districts in 2018 and has backed Ms. Smith, had so many volunteers for at-home phone banks in recent weeks that it had to create a waiting list and wrote postcards to send to every voter in the district.

“People are really motivated to defend what they won, and there’s definitely still a lot of energy among volunteers,” said Lucy Solomon, a national political director for the group. But she tempered her optimism. “It’s impossible to know how coronavirus is going to affect the outcome,” she said.

Though Mr. Padilla expects that the overwhelming majority of voters will choose to mail in their ballots, a few in-person voting options will be open on May 12, mostly to allow for same-day voter registration.

Still, he cautioned, if the results show a close race, a winner might not be clear for days, or even weeks. And no matter who wins, a rematch is expected in November, when the candidates will battle for the full congressional term.

Catie Edmondson contributed reporting from Washington.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus.

Westlake Legal Group 00virus-avigan-1-facebookJumbo Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus. Trump, Donald J Tests (Medical) Politics and Government Japan Hydroxychloroquine (Drug) Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Abe, Shinzo

TOKYO — As President Trump was extolling the promise of a malaria drug in the desperate hunt for coronavirus treatments, one of his top global allies was selling the world on his own “trump card,” a pale yellow pill that he said could be crucial to fighting the pandemic.

This supposed beacon of hope is an antiviral medicine known as Avigan, and its most vocal proponent is Japan’s prime minister, Shinzo Abe.

Mr. Abe has pushed the homegrown drug in news conferences and in meetings with world leaders, including a call with Mr. Trump and the other heads of the Group of 7. He has allocated nearly $130 million to triple an existing stockpile of the medication. And he has offered to provide it free to dozens of other countries.

The prime minister, however, has glossed over one crucial fact: There is no solid evidence that Avigan is actually effective against Covid-19. While the drug has shown potential for treating some deadly diseases like Ebola in animal studies, there are limited findings that it works for any illness in humans.

What Avigan, whose generic name is favipiravir, does have is a peculiar regulatory history and one dangerous potential side effect — birth defects. Mr. Abe himself noted in a news conference on Monday that the side effect was “the same as thalidomide,” which caused 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.

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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 government has attested to its safety and effectiveness against Covid-19.

On Japanese television, doctors are calling the pill a possible global savior, and celebrities who have taken it have offered glowing testimonials.

But that evidence is entirely anecdotal, said Masaya Yamato, chief of infectious diseases at Rinku General Medical Center in Osaka, who served on a 2016 government panel that considered the drug as a last line of defense against new types of influenza.

“I’m not saying this medicine doesn’t work. I’m saying there’s still no proof that it works,” Dr. Yamato said.

A spokeswoman for Fujifilm, Kana Matsumoto, said that the company was conducting clinical trials in Japan and the United States “in order to obtain substantial evidence of the drug’s efficacy” against Covid-19.

Avigan is potentially valuable because it functions differently from most other antivirals, interfering with viruses’ reproduction, instead of stopping them from entering cells. In studies on animals, the drug has appeared capable of curbing the propagation of certain viruses like Ebola, especially when administered early.

The drug also has major problems. Evidence of birth defects in animal trials led Japan to put unusually strict controls on the pill’s use and production. Before the coronavirus, it had been given to humans only during clinical trials and in desperate attempts to treat Ebola. None of those efforts delivered definitive evidence that it effectively treats any disease in humans, even common types of influenza, Dr. Yamato said.

If Avigan works against Covid-19, it is most likely useful in the illness’s early stages, said Norio Sugaya, an infectious diseases expert at Keiyu Hospital in Yokohama.

Dr. Sugaya said he believed the drug could be useful as a prophylactic if combined with widespread testing, a softening of the views he shared with the government task force in 2016, when he argued that the drug was unproven and should not be stockpiled.

Despite the warnings, officials at the time decided to purchase enough pills for two million patients, a stockpile that is now being tapped. So far, 1,100 Japanese medical facilities have given Avigan to almost 2,200 Covid-19 patients, with more than a thousand on wait lists for the drug, government data showed.

Many of those facilities are not applying rigorous scientific controls, such as double-blinding and the use of placebos. They argue that the potential benefits outweigh the risks, particularly in the elderly, for whom the problem of birth defects is unlikely to be an issue.

Fujifilm and others are now conducting proper trials of the drug for Covid-19. But Mr. Abe has rushed ahead of that process by calling for Avigan’s use to be expanded even further, by urging hospitals to give it to anyone who wants it, and by telling patients to ask for it by name.

On Monday, he said that the approval process would probably not depend on traditional clinical trials carried out by the developer, but instead would most likely take a “different form” after experts made a judgment about the drug’s effectiveness.

It is not clear why he has been such a vocal advocate. Some Japanese media have noted his close ties to Fujifilm’s chief executive, Shigetaka Komori. The two men have often golfed and eaten together, last meeting on Jan. 17, according to the prime minister’s schedule.

In mid-February, Fujifilm was the only company invited to attend a government task force meeting on international cooperation against the virus, according to materials from the meeting posted online.

Its representatives presented a 27-page PowerPoint presentation noting that the Chinese government was preparing to approve the medication for use on an emergency basis. The Chinese patent on Avigan expired last year, and if Japan dawdled, it could lose a potentially enormous market for the medicine.

In a news conference on Feb. 29, Mr. Abe said Japan was testing three treatments against the virus, mentioning only Avigan by name. The next week, the chief cabinet secretary, Yoshihide Suga, told reporters that Mr. Abe’s relationship with Fujifilm’s chief executive had “absolutely no connection” to the prime minister’s views on the pill.

Government officials are thinking “it’s a drug that’s made in Japan, so let’s use it if we can,” said Dr. Yamato, the infectious diseases expert.

The Fujifilm spokeswoman said “there has never been any favorable treatment” from Mr. Abe or his administration.

The drug gained further support in March, when two Chinese research teams posted papers online suggesting that it had hastened the recovery of patients experiencing mild to moderate cases of Covid-19.

Chinese officials, who have been stung by criticism that they initially covered up the outbreak, began promoting the findings as an example of the country’s successful response to the virus.

But scientists soon began picking the papers apart, arguing that they lacked basic scientific controls. Both papers, which had not been peer reviewed, were revised, their conclusions becoming less assured.

Nevertheless, China quickly approved Avigan for use against Covid-19. It was the first time any country outside Japan had approved its use against any disease.

Japan itself had only conditionally greenlighted the drug in 2014 under what medical watchdogs describe as highly unusual circumstances.

In their assessment, regulators wrote that Avigan “has not shown effectiveness” against seasonal influenza and could not be approved for use against it. Instead, they would allow its use against new or re-emergent strains of influenza, but only in “crisis” situations when existing antivirals proved ineffective.

Ms. Matsumoto, Fujifilm’s spokeswoman, said that the approval process was “robust and rigorous.”

In a report issued Friday, Medwatcher Japan, a nonprofit group that monitors the pharmaceutical industry, described the approval process as “exceedingly abnormal.”

“It’s unbelievable that it was ever stockpiled as an influenza drug,” said Masumi Minaguchi, the group’s secretary general. “And it’s even more unbelievable, that under these circumstances, even without any scientific basis, people are being told to use it.”

Hisako Ueno and Makiko Inoue contributed reporting from Tokyo, and Cao Li from Hong Kong.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus.

Westlake Legal Group 00virus-avigan-1-facebookJumbo Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus. Trump, Donald J Tests (Medical) Politics and Government Japan Hydroxychloroquine (Drug) Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Abe, Shinzo

TOKYO — As President Trump was extolling the promise of a malaria drug in the desperate hunt for coronavirus treatments, one of his top global allies was selling the world on his own “trump card,” a pale yellow pill that he said could be crucial to fighting the pandemic.

This supposed beacon of hope is an antiviral medicine known as Avigan, and its most vocal proponent is Japan’s prime minister, Shinzo Abe.

Mr. Abe has pushed the homegrown drug in news conferences and in meetings with world leaders, including a call with Mr. Trump and the other heads of the Group of 7. He has allocated nearly $130 million to triple an existing stockpile of the medication. And he has offered to provide it free to dozens of other countries.

The prime minister, however, has glossed over one crucial fact: There is no solid evidence that Avigan is actually effective against Covid-19. While the drug has shown potential for treating some deadly diseases like Ebola in animal studies, there are limited findings that it works for any illness in humans.

What Avigan, whose generic name is favipiravir, does have is a peculiar regulatory history and one dangerous potential side effect — birth defects. Mr. Abe himself noted in a news conference on Monday that the side effect was “the same as thalidomide,” which caused 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.

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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 government has attested to its safety and effectiveness against Covid-19.

On Japanese television, doctors are calling the pill a possible global savior, and celebrities who have taken it have offered glowing testimonials.

But that evidence is entirely anecdotal, said Masaya Yamato, chief of infectious diseases at Rinku General Medical Center in Osaka, who served on a 2016 government panel that considered the drug as a last line of defense against new types of influenza.

“I’m not saying this medicine doesn’t work. I’m saying there’s still no proof that it works,” Dr. Yamato said.

A spokeswoman for Fujifilm, Kana Matsumoto, said that the company was conducting clinical trials in Japan and the United States “in order to obtain substantial evidence of the drug’s efficacy” against Covid-19.

Avigan is potentially valuable because it functions differently from most other antivirals, interfering with viruses’ reproduction, instead of stopping them from entering cells. In studies on animals, the drug has appeared capable of curbing the propagation of certain viruses like Ebola, especially when administered early.

The drug also has major problems. Evidence of birth defects in animal trials led Japan to put unusually strict controls on the pill’s use and production. Before the coronavirus, it had been given to humans only during clinical trials and in desperate attempts to treat Ebola. None of those efforts delivered definitive evidence that it effectively treats any disease in humans, even common types of influenza, Dr. Yamato said.

If Avigan works against Covid-19, it is most likely useful in the illness’s early stages, said Norio Sugaya, an infectious diseases expert at Keiyu Hospital in Yokohama.

Dr. Sugaya said he believed the drug could be useful as a prophylactic if combined with widespread testing, a softening of the views he shared with the government task force in 2016, when he argued that the drug was unproven and should not be stockpiled.

Despite the warnings, officials at the time decided to purchase enough pills for two million patients, a stockpile that is now being tapped. So far, 1,100 Japanese medical facilities have given Avigan to almost 2,200 Covid-19 patients, with more than a thousand on wait lists for the drug, government data showed.

Many of those facilities are not applying rigorous scientific controls, such as double-blinding and the use of placebos. They argue that the potential benefits outweigh the risks, particularly in the elderly, for whom the problem of birth defects is unlikely to be an issue.

Fujifilm and others are now conducting proper trials of the drug for Covid-19. But Mr. Abe has rushed ahead of that process by calling for Avigan’s use to be expanded even further, by urging hospitals to give it to anyone who wants it, and by telling patients to ask for it by name.

On Monday, he said that the approval process would probably not depend on traditional clinical trials carried out by the developer, but instead would most likely take a “different form” after experts made a judgment about the drug’s effectiveness.

It is not clear why he has been such a vocal advocate. Some Japanese media have noted his close ties to Fujifilm’s chief executive, Shigetaka Komori. The two men have often golfed and eaten together, last meeting on Jan. 17, according to the prime minister’s schedule.

In mid-February, Fujifilm was the only company invited to attend a government task force meeting on international cooperation against the virus, according to materials from the meeting posted online.

Its representatives presented a 27-page PowerPoint presentation noting that the Chinese government was preparing to approve the medication for use on an emergency basis. The Chinese patent on Avigan expired last year, and if Japan dawdled, it could lose a potentially enormous market for the medicine.

In a news conference on Feb. 29, Mr. Abe said Japan was testing three treatments against the virus, mentioning only Avigan by name. The next week, the chief cabinet secretary, Yoshihide Suga, told reporters that Mr. Abe’s relationship with Fujifilm’s chief executive had “absolutely no connection” to the prime minister’s views on the pill.

Government officials are thinking “it’s a drug that’s made in Japan, so let’s use it if we can,” said Dr. Yamato, the infectious diseases expert.

The Fujifilm spokeswoman said “there has never been any favorable treatment” from Mr. Abe or his administration.

The drug gained further support in March, when two Chinese research teams posted papers online suggesting that it had hastened the recovery of patients experiencing mild to moderate cases of Covid-19.

Chinese officials, who have been stung by criticism that they initially covered up the outbreak, began promoting the findings as an example of the country’s successful response to the virus.

But scientists soon began picking the papers apart, arguing that they lacked basic scientific controls. Both papers, which had not been peer reviewed, were revised, their conclusions becoming less assured.

Nevertheless, China quickly approved Avigan for use against Covid-19. It was the first time any country outside Japan had approved its use against any disease.

Japan itself had only conditionally greenlighted the drug in 2014 under what medical watchdogs describe as highly unusual circumstances.

In their assessment, regulators wrote that Avigan “has not shown effectiveness” against seasonal influenza and could not be approved for use against it. Instead, they would allow its use against new or re-emergent strains of influenza, but only in “crisis” situations when existing antivirals proved ineffective.

Ms. Matsumoto, Fujifilm’s spokeswoman, said that the approval process was “robust and rigorous.”

In a report issued Friday, Medwatcher Japan, a nonprofit group that monitors the pharmaceutical industry, described the approval process as “exceedingly abnormal.”

“It’s unbelievable that it was ever stockpiled as an influenza drug,” said Masumi Minaguchi, the group’s secretary general. “And it’s even more unbelievable, that under these circumstances, even without any scientific basis, people are being told to use it.”

Hisako Ueno and Makiko Inoue contributed reporting from Tokyo, and Cao Li from Hong Kong.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus.

Westlake Legal Group 00virus-avigan-1-facebookJumbo Avigan May Cause Birth Defects. Japan’s Pushing It for Coronavirus. Trump, Donald J Tests (Medical) Politics and Government Japan Hydroxychloroquine (Drug) Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Abe, Shinzo

TOKYO — As President Trump was extolling the promise of a malaria drug in the desperate hunt for coronavirus treatments, one of his top global allies was selling the world on his own “trump card,” a pale yellow pill that he said could be crucial to fighting the pandemic.

This supposed beacon of hope is an antiviral medicine known as Avigan, and its most vocal proponent is Japan’s prime minister, Shinzo Abe.

Mr. Abe has pushed the homegrown drug in news conferences and in meetings with world leaders, including a call with Mr. Trump and the other heads of the Group of 7. He has allocated nearly $130 million to triple an existing stockpile of the medication. And he has offered to provide it free to dozens of other countries.

The prime minister, however, has glossed over one crucial fact: There is no solid evidence that Avigan is actually effective against Covid-19. While the drug has shown potential for treating some deadly diseases like Ebola in animal studies, there are limited findings that it works for any illness in humans.

What Avigan, whose generic name is favipiravir, does have is a peculiar regulatory history and one dangerous potential side effect — birth defects. Mr. Abe himself noted in a news conference on Monday that the side effect was “the same as thalidomide,” which caused 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.

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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 government has attested to its safety and effectiveness against Covid-19.

On Japanese television, doctors are calling the pill a possible global savior, and celebrities who have taken it have offered glowing testimonials.

But that evidence is entirely anecdotal, said Masaya Yamato, chief of infectious diseases at Rinku General Medical Center in Osaka, who served on a 2016 government panel that considered the drug as a last line of defense against new types of influenza.

“I’m not saying this medicine doesn’t work. I’m saying there’s still no proof that it works,” Dr. Yamato said.

A spokeswoman for Fujifilm, Kana Matsumoto, said that the company was conducting clinical trials in Japan and the United States “in order to obtain substantial evidence of the drug’s efficacy” against Covid-19.

Avigan is potentially valuable because it functions differently from most other antivirals, interfering with viruses’ reproduction, instead of stopping them from entering cells. In studies on animals, the drug has appeared capable of curbing the propagation of certain viruses like Ebola, especially when administered early.

The drug also has major problems. Evidence of birth defects in animal trials led Japan to put unusually strict controls on the pill’s use and production. Before the coronavirus, it had been given to humans only during clinical trials and in desperate attempts to treat Ebola. None of those efforts delivered definitive evidence that it effectively treats any disease in humans, even common types of influenza, Dr. Yamato said.

If Avigan works against Covid-19, it is most likely useful in the illness’s early stages, said Norio Sugaya, an infectious diseases expert at Keiyu Hospital in Yokohama.

Dr. Sugaya said he believed the drug could be useful as a prophylactic if combined with widespread testing, a softening of the views he shared with the government task force in 2016, when he argued that the drug was unproven and should not be stockpiled.

Despite the warnings, officials at the time decided to purchase enough pills for two million patients, a stockpile that is now being tapped. So far, 1,100 Japanese medical facilities have given Avigan to almost 2,200 Covid-19 patients, with more than a thousand on wait lists for the drug, government data showed.

Many of those facilities are not applying rigorous scientific controls, such as double-blinding and the use of placebos. They argue that the potential benefits outweigh the risks, particularly in the elderly, for whom the problem of birth defects is unlikely to be an issue.

Fujifilm and others are now conducting proper trials of the drug for Covid-19. But Mr. Abe has rushed ahead of that process by calling for Avigan’s use to be expanded even further, by urging hospitals to give it to anyone who wants it, and by telling patients to ask for it by name.

On Monday, he said that the approval process would probably not depend on traditional clinical trials carried out by the developer, but instead would most likely take a “different form” after experts made a judgment about the drug’s effectiveness.

It is not clear why he has been such a vocal advocate. Some Japanese media have noted his close ties to Fujifilm’s chief executive, Shigetaka Komori. The two men have often golfed and eaten together, last meeting on Jan. 17, according to the prime minister’s schedule.

In mid-February, Fujifilm was the only company invited to attend a government task force meeting on international cooperation against the virus, according to materials from the meeting posted online.

Its representatives presented a 27-page PowerPoint presentation noting that the Chinese government was preparing to approve the medication for use on an emergency basis. The Chinese patent on Avigan expired last year, and if Japan dawdled, it could lose a potentially enormous market for the medicine.

In a news conference on Feb. 29, Mr. Abe said Japan was testing three treatments against the virus, mentioning only Avigan by name. The next week, the chief cabinet secretary, Yoshihide Suga, told reporters that Mr. Abe’s relationship with Fujifilm’s chief executive had “absolutely no connection” to the prime minister’s views on the pill.

Government officials are thinking “it’s a drug that’s made in Japan, so let’s use it if we can,” said Dr. Yamato, the infectious diseases expert.

The Fujifilm spokeswoman said “there has never been any favorable treatment” from Mr. Abe or his administration.

The drug gained further support in March, when two Chinese research teams posted papers online suggesting that it had hastened the recovery of patients experiencing mild to moderate cases of Covid-19.

Chinese officials, who have been stung by criticism that they initially covered up the outbreak, began promoting the findings as an example of the country’s successful response to the virus.

But scientists soon began picking the papers apart, arguing that they lacked basic scientific controls. Both papers, which had not been peer reviewed, were revised, their conclusions becoming less assured.

Nevertheless, China quickly approved Avigan for use against Covid-19. It was the first time any country outside Japan had approved its use against any disease.

Japan itself had only conditionally greenlighted the drug in 2014 under what medical watchdogs describe as highly unusual circumstances.

In their assessment, regulators wrote that Avigan “has not shown effectiveness” against seasonal influenza and could not be approved for use against it. Instead, they would allow its use against new or re-emergent strains of influenza, but only in “crisis” situations when existing antivirals proved ineffective.

Ms. Matsumoto, Fujifilm’s spokeswoman, said that the approval process was “robust and rigorous.”

In a report issued Friday, Medwatcher Japan, a nonprofit group that monitors the pharmaceutical industry, described the approval process as “exceedingly abnormal.”

“It’s unbelievable that it was ever stockpiled as an influenza drug,” said Masumi Minaguchi, the group’s secretary general. “And it’s even more unbelievable, that under these circumstances, even without any scientific basis, people are being told to use it.”

Hisako Ueno and Makiko Inoue contributed reporting from Tokyo, and Cao Li from Hong Kong.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Biden Camp Finds Selling Point in Ailing Economy: His Work on 2009 Recovery

Westlake Legal Group 05BidenStimulus-01-facebookJumbo Biden Camp Finds Selling Point in Ailing Economy: His Work on 2009 Recovery United States Politics and Government United States Economy Trump, Donald J Recession and Depression Presidential Election of 2020 Presidential Election of 2008 Obama, Barack Coronavirus Aid, Relief, and Economic Security Act (2020) Coronavirus (2019-nCoV) Biden, Joseph R Jr American Recovery and Reinvestment Act (2009)

Joseph R. Biden Jr. had just been sworn in as vice president. All he needed now was a job.

During the 2008 campaign, Barack Obama had assured Mr. Biden that he would be consulted on every major decision. But many on the new president’s team were still Biden-skeptical, and Mr. Obama was not sure the meandering former senator had the discipline to be an effective governing partner, people close to both men said.

So, during a private lunch in February 2009, Mr. Biden slid a memo across the table to Mr. Obama, outlining a role to erase those doubts: quarterbacking the implementation of the $787 billion economic stimulus that had been rammed through Congress a few days earlier in the depths of recession.

“Sounds good to me,” said Mr. Obama, barely glancing at the memo, according to two people familiar with the exchange.

Mr. Obama was already pivoting to health care reform, so why not encharge Mr. Biden? As it turned out, Mr. Biden’s work on the rollout, implementation, oversight and selling of the 2009 stimulus — officially the American Recovery and Reinvestment Act — was the most sustained, and perhaps the most significant, assignment of his time in office.

Eleven years later, in an election season defined by pandemic, economic collapse and a far-larger relief package, Mr. Biden’s campaign is hoping to leverage his stewardship of the 2009 stimulus as a point of contrast with President Trump — whose White House is pushing back at congressional oversight of $2.7 trillion in new spending even as a host of problems has emerged, especially chaos in the small-business loan program.

“The central question of this election will be who can dig us out of a historic economic hole, so his leadership of the recovery act should be his core résumé selling point,” said David Plouffe, Mr. Obama’s top political adviser and a Biden surrogate.

An examination of that critical two-year period, drawn from interviews with 30 people involved in the effort, offers a glimpse of Mr. Biden’s strengths as a manager — his enthusiasm, focus on detail and knack for leading a first-rate team that moved the money out quickly and minimized waste and fraud. It was “one big competence test,” and Mr. Biden aced it, his longtime lieutenant, Ron Klain, said in an interview.

But the stimulus says more about the kind of vice president Mr. Biden was than about the kind of president he would be. While he became the expediter-in-chief and offered Mr. Obama advice and tactical suggestions, he made none of the major strategic calls about the size and composition of the program, aides said. Nor did he seriously push Mr. Obama — as he is now pressuring Mr. Trump — to fight for a bigger funding package, even though former officials said he conceded the stimulus was probably too small.

There was nothing ambiguous, though, about the impact of the stimulus on Mr. Biden’s political fortunes.

“It sort of made him, to be honest, in the eyes of the Obama people,” said Ray LaHood, a former Republican congressman who served as Mr. Obama’s transportation secretary.

Mr. Obama picked Mr. Biden, in part, because he viewed him as a past-tense presidential aspirant. Yet if overseeing the stimulus proved Mr. Biden was a team player, his pursuit of the assignment — and he wanted it badly — was also a sign that he had never entirely abandoned his own political ambitions. In the end, the stimulus catalyzed his emergence as Mr. Obama’s trusted partner and, eventually, set him up as a presidential contender.

Mr. Biden mentioned the stimulus only in passing on the 2020 trail, when there was a trail, and has only recently begun invoking it as a campaign theme. There is broad agreement that the program had a positive impact on an economy in free fall, with the nonpartisan Congressional Budget Office concluding that it created between two million and 4.8 million full-time jobs.

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But it left a bittersweet aftertaste, attacked by progressives as insufficiently bold and savaged by Republicans to this day as a boondoggle — with the Republican National Committee chairwoman, Ronna McDaniel, saying in an email last week that the stimulus “proves” Mr. Biden cannot run a government. For much of the public, however, it is a half-forgotten episode, wedged between the deeply unpopular Bush administration bank bailout and the polarizing war over Obamacare.

“The big problem, when you get right down it, is that we succeeded in making the situation less bad rather than good — so how do you sell that?” said Jared Bernstein, Mr. Biden’s top economic adviser during his vice presidency.

The stimulus was born on a snow-sodden December day at Mr. Obama’s Chicago headquarters, a few weeks after the 2008 election.

There had been earlier talk of a smaller package, but the Obama economic team, led by Mr. Bernstein and Christina Romer, incoming chairwoman of the Council of Economic Advisers, said many, many hundreds of billions were needed immediately to prevent a second Great Depression.

Mr. Biden, participants recalled, spoke up for pro-worker provisions, funding for green energy projects and light rail. Later, he would intervene to insert $10 billion in additional funding for the National Institutes of Health. But he mainly supported the work of Mr. Bernstein, who played a central role in formulating the menu of infrastructure projects, payroll-tax cuts and aid to localities.

Mr. Obama’s top advisers were initially optimistic about winning Republican backing, telling aides to Nancy Pelosi, the speaker of the House, that they could secure up to 80 votes in the Senate. Mr. Biden knew better, telling the speaker and Mr. Obama they would snag four or five Republicans at most.

“Don’t listen to any of this happy-talk crap,” he said, according to a senior Obama adviser.

Ultimately three Republicans voted for the bill, and only after Mr. Biden helped wheedle a yes from his close friend Arlen Specter, a moderate from Pennsylvania.

Once the fight was over, Mr. Biden’s chief of staff, Mr. Klain, who had held the same post for Vice President Al Gore, drafted the implementation plan that Mr. Obama did not need to read. It amounted to a congenial power grab, giving Mr. Biden expansive influence over which projects, submitted by local officials and cabinet departments, would be funded.

Mr. Biden’s first priority, according to Mr. Klain, was creating a central management structure, aimed at avoiding the kind of confusion that has thus far plagued the financial response to the coronavirus crisis under Mr. Trump.

Mr. Klain and his team broke their mission into three parts: identifying “shovel-ready” projects, minimizing misuse of the funding (including the creation of an online transaction tracker, Recovery.gov) and trying to muster public enthusiasm.

Mr. Biden started by auditioning veteran state and federal officials for the 10-person operation that would oversee the effort, attacking the task with an abrasive impatience that belied his jovial “Uncle Joe” image. “He was a yeller,” one adviser recalled. He wanted an exemption from Obama administration rules that banned ex-lobbyists from being hired for their expertise, but was quickly shot down — although he often grumbled about it, another aide recalled.

A federal official who had business with the new vice president in early 2009 described the following the scene: Mr. Biden arrived 15 minutes late, ripped off his suit jacket and began rattling off questions in front of a roaring fire that turned his office into a furnace — to the stifling discomfort of his visitor, who did not have the option of taking off his coat.

He left much of the initial vetting of projects to his team, and spent much of his time pressuring mayors, governors and cabinet officials to accelerate work that would create jobs and momentum for the besieged administration.

“He was very impatient at first,” said G. Edward DeSeve, a veteran federal oversight specialist recruited by Mr. Biden. “But it didn’t take him too long to gain an understanding of just how big a task it was to run something on this scale.”

A frequent source of heartburn, aides said, was the water and sewer projects overseen by the Environmental Protection Agency, which were subject to an array of federal and local regulations. A multibillion-dollar effort to weatherize homes, considered a fast way to inject cash into the economy, became tangled in red tape, in part because of labor protections Mr. Biden had championed during the transition.

A marquee project in Mr. Biden’s birthplace state, Pennsylvania, was a $1.7 million replacement of the bridge over Conodoguinet Creek near Harrisburg. It, too, seemed like a straightforward-enough proposition, and Mr. Biden hoped to kick off a national barnstorming tour there within weeks.

No go, state officials shot back. The earliest date was several months out.

Nothing proved quite so nettlesome as the project closest to Mr. Biden’s heart. He had successfully lobbied to include $8 billion for high-speed rail projects, but his plans were slowed when two conservative Republican governors riding the Tea Party backlash, Rick Scott of Florida and Scott Walker of Wisconsin, rejected the cash.

“It would have required a major investment by the state at a time when we were dealing with our own budget crisis,” said Mr. Scott, now a senator, explaining his decision to turn down $2 billion for a route connecting Tampa and Orlando. The money was eventually diverted to other states.

The desire for speed contributed to what would become the centerpiece of Republican efforts to discredit the stimulus — the collapse of Solyndra, a California-based solar-panel manufacturer that went bankrupt after receiving $527 million in loan guarantees.

Mr. Biden’s advisers placed the blame on China, for glutting the market with cheap panels. But the nonpartisan Government Accountability Office, describing the rushed review process as “alarming,” concluded that the Energy Department had given preliminary loan approvals before completing detailed assessments of the company’s projects.

For all that, the episode was more exception than norm. By September 2010, a panel monitoring allegations of fraud and abuse concluded stimulus had a 0.2 percent incidence of waste and fraud. That finding was not seriously contested by Republican investigators in Congress, and an 18-month congressional inquiry into Solyndra found no evidence of malfeasance or favoritism.

Still, the drip-drip of Republican attacks was quickly turning the program into a political liability.

The sharpest attacks came from friends of the president and vice president, Senators Tom Coburn of Oklahoma and John McCain of Arizona, who began scouring Recovery.com for projects they deemed silly or wasteful, including an online dance course and a study of the effects of cocaine on monkeys.

Nitpicks weren’t the biggest problem, though. Numbers were.

Mr. Biden’s team achieved its goal of spending 70 percent, or roughly $550 billion, of the stimulus funding in the first 18 months. But it took longer than the White House had expected for its effects to be felt. Republicans seized on a January 2009 report in which Biden economic advisers had predicted unemployment would peak at around 8 percent under the stimulus. By October 2009 the rate had hit 10 percent, and it would not fall below the 8 percent benchmark until September 2012.

Mr. Obama’s own approval numbers were sagging, too. “The only thing that is more unpopular than me right now is the stimulus,” Mr. Obama tartly declared at a cabinet meeting around that time, as Mr. Biden listened in silence, according to a person in the room. Eventually, the president dropped the word “stimulus” from his speeches, one former adviser said.

Against that backdrop, Mr. Biden, anointed salesman of the stimulus, was crisscrossing the country trying to gin up excitement, and focusing on what he could control, like making sure the recovery act signs on highway projects were large enough to be seen by motorists. (He also viewed his trips to Midwestern battleground states as opportunities to cement his connection to blue-collar voters, should he ever run for president again, several people close to him said, and he would invoke the stimulus during the 2012 re-election campaign.)

At the same time, he was quietly pressuring Mr. Obama to take more public credit for the one element of the stimulus that put $400 to $800 in tax credits directly into people’s pockets. Writing a single check to taxpayers might have been better politics, but Mr. Obama’s economics working group decided it was better to distribute the money in small increments to encourage spending.

Mr. Klain was livid that the “nerds” had won the argument, a former aide said, and Mr. Biden turned to a plan from another old friend, Gov. Ed Rendell of Pennsylvania.

“Let’s have Treasury send a letter to every taxpayer saying, ‘President Obama wants you to spend this money immediately,’” Mr. Rendell recalled in a recent interview. “It wasn’t like Trump putting his name on the check, but it let people know Obama had done this thing for them.”

Mr. Biden brought the idea to Mr. Obama, and there it remained. “Jesus, that was dumb,” Mr. Rendell said.

By the fall of 2009, the external narrative — that the stimulus had significant economic value but little political currency — seemed set. At the same time, an internal narrative was falling into place: Joe Biden could be trusted.

It has proved to be a durable story line, at least inside the party. “Joe led with integrity, which is an enormous contrast from the current administration,” Senator Elizabeth Warren of Massachusetts, who cited the stimulus in her recent endorsement of Mr. Biden, wrote in an email.

The two coronavirus rescue packages differ from the Obama stimulus in significant ways, with most cash being sent directly to taxpayers and businesses. Still, both were backstops against economic calamity, and the new law contains accountability provisions modeled on the 2009 legislation.

But Mr. Trump has not embraced oversight as Mr. Obama did, nor has he deployed Vice President Mike Pence in the Biden watchdog role, leaving the task to various administration officials, like Treasury Secretary Steven Mnuchin.

Mr. Biden, already annoyed at having to campaign from his basement in Delaware, exploded: “What a joke! You’ve got to be kidding me!” he shouted, inserting expletives, according to two people who talked with him.

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Both Parties Wonder: How Much Do Conventions Even Matter Anymore?

Westlake Legal Group merlin_110152672_31606c7e-bc29-4d4e-9b27-056c5fc86fd8-facebookJumbo Both Parties Wonder: How Much Do Conventions Even Matter Anymore? Trump, Donald J Republican Party Republican National Convention Quarantines Primaries and Caucuses Presidential Election of 2020 Political Advertising Democratic Party Democratic National Convention Coronavirus (2019-nCoV) Biden, Joseph R Jr

Political conventions have been a balloons-and-bunting mainstay of American campaigns since the Republican Party gathered in Baltimore to nominate Henry Clay for president in 1831. But this year, they may join the list of crowded events — concerts, baseball games, movies and Broadway shows — forced off the stage because of the coronavirus.

And it may not matter.

Some Democratic leaders are discussing replacing their convention with a virtual gathering, and some Republicans are unsure about holding the big spectacle that President Trump wants. Yet even before the pandemic, a more fundamental debate was playing out: Has the American political convention become a ritual holdover from another age?

For all the organizing, money, time and energy poured into a four-day extravaganza of parties, speeches, forums, lobbying and networking, there is a strong argument that they have become among the less consequential events on the political calendar.

Yes, candidates get their prime-time perch to speak to the nation. Party delegates debate obscure bylaws and approve a platform that is likely to be forgotten the moment the final gavel is dropped. The events can provide a lift in the polls, but there is no shortage of convention nominees, John McCain and Michael S. Dukakis among them, who can attest to just how ephemeral that boost is.

For all the talk of brokered conventions, it has been a long time since delegates had anything more to do than ratify a presidential candidate selected by primary voters and a running mate chosen by the nominee. As the drama has slipped away, so have the television networks, systematically cutting back on the hours of prime-time coverage devoted to events that have become little more than scripted advertisements.

The parties themselves have become far less influential, particularly since Mr. Trump overcame the Republican power structure to win the nomination in 2016. They have been weakened by rising anti-establishment beliefs on the left and the right, notably among younger voters, and by the sentiment that parties are not as essential to ideas or governing anymore. The waning significance of conventions, long the grandest symbol of old-guard party-building, would appear to be of a piece.

Terry McAuliffe, the former governor of Virginia who was the chairman of the 2000 Democratic convention in Los Angeles, likened the conventions to a high school reunion. “The party loves to get together,” he said. But Mr. McAuliffe said he was not particularly bothered by the possibility that Democrats would not hold a convention in person this year to nominate former Vice President Joseph R. Biden Jr.

“Listen, I’m a big lover of them,” Mr. McAuliffe said. “But if we don’t have one, it’s going to be just fine. The real goal is introducing Biden. There are a lot of creative ways to do it if we don’t have a convention.”

And in interviews with over a dozen emissaries and operatives from both parties, there was a strong view, especially among younger generations, that the value of conventions has flagged as the rules of politics have changed.

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“Our political memories have become so short that we can barely remember Trump’s monthslong impeachment saga, let alone a weeklong infomercial for our party’s nominee,” said Zac Petkanas, an aide on Hillary Clinton’s presidential campaign in 2016. “The dirty little secret of politics is that 80 percent of what everyone thinks is important in campaigns doesn’t matter one little bit.”

He said that any obsession with conventions reflected a “1990s perspective” divorced from Trump-era news velocity.

Kevin Madden, who was a senior adviser to Mitt Romney, the Republican nominee for president in 2012, recalled that the party’s convention that year produced just one enduring scene: a curious, semi-scripted bit from the actor Clint Eastwood, who conversed onstage with an empty chair.

“They spend a year developing, it’ll take an hour to execute, and right afterward the effect will already be going through its life cycle,” Mr. Madden said of the modern convention, “and disappearing into another chaotic media environment.”

There is certainly a constituency for this kind of American tradition, particularly among political leaders who have spent a lifetime attending these quadrennial gatherings.

“I’m the old-fashioned guy here,” said Walter F. Mondale, the former Democratic vice president who was nominated to run for president at the party’s 1984 convention in San Francisco. “I have always liked political conventions: the consultations, the debates, the votes, the roll-calls and other things. I’ve lived with it my whole life and I’ve liked it.”

“I don’t know what the alternative is,” he said.

Jennifer Palmieri, who was a senior aide to President Barack Obama and to Mrs. Clinton, the Democratic candidate nominated to succeed him in 2016, said she had come to see the prime-time speeches from party nominees as meaningful moments, “not just for the candidate but for the country.”

“It’s the organizing principle for the campaign, a kickoff to the fall, a way for the ticket to present a comprehensive articulation of how they would govern,” she said of conventions.

Russell J. Schriefer, the Republican consultant who was the program manager for the Republican conventions in 2004 and 2012, said these gatherings served a purpose, though perhaps not as critical a purpose as they once did.

“Despite the fact that we’re not selecting our nominees there anymore, they can act as a final stopgap if a nomination is in question, and it can go to the floor,” he said. “Those rules still exist. It just hasn’t happened for a long time.”

Mr. Dukakis, a former governor of Massachusetts, said he thought the 1988 Democratic convention where he was nominated had helped him — but not for long. “We were great coming out of it,” he said. “I think I had some pretty significant momentum coming out of it and kind of screwed it up. Is it helpful if it’s a successful convention? Yes, it’s a plus.”

Conventions have certainly provided memorable moments. The appearance of Mr. Obama, then a U.S. Senate candidate from Illinois, at the 2004 convention in Boston put him on a path to the White House. The 1984 “shining city upon a hill” speech by Mario M. Cuomo, the Democratic governor of New York, defined his legacy as much as anything he ever did as governor.

But those were hardly recent.

And if a principal purpose of conventions has been the projection of party unity after a fractious primary race, recent history has been checkered — and heavy on conspicuous booing.

In 2016, supporters of Mr. Trump jeered Senator Ted Cruz, the Texas Republican and his chief rival in the Republican primaries, who pointedly declined to endorse Mr. Trump from the convention stage, urging attendees to “vote your conscience” in November. On the Democratic side, delegates of Senator Bernie Sanders of Vermont repeatedly heckled party officials, admirers of Mrs. Clinton and even Mr. Sanders himself when he asked his supporters to back her.

Asked whether the Democratic convention was ultimately helpful to Mrs. Clinton, Leah Daughtry, the event’s chief executive, paused. “I think so,” she said. “When the balloons are dropping and the nominee is out onstage, there’s a certain amount of closure. Of course, there were those for whom that was not a satisfactory outcome. I don’t know that anything would have been a satisfactory outcome.”

Mindful of the loyal passion of Sanders voters, some Biden allies have wondered in recent weeks if a scaled-down virtual convention might at least deliver a silver lining: fewer opportunities for the Vermont senator’s supporters to register their disappointment in open view.

Of course, things could have been more complicated.

Gary W. Hart, the former Colorado senator who twice ran unsuccessfully for the Democratic presidential nomination, suggested the party was fortunate that the race had clarified itself — Mr. Biden took command in early March — before the pandemic upended the campaign.

“I don’t know how they would have done it,” Mr. Hart said of a socially distanced contested convention. “A big Zoom.”

Whatever Mr. Trump has in mind for this summer, party leaders have begun weighing the ramifications of a partisan convention divide: the possibility of a Republican convention in Charlotte, in person as planned, and a Democratic convention held remotely — consistent with a higher regard for public health warnings among Democrats.

For all that, the romantic attachment to conventions endures, a place for party members to reconnect with old friends or fight old fights, be quoted in their local newspapers or booked onto “This Week With George Stephanopoulos,” or just to feast on four days of open bars and buffet tables.

“I’m a fan of in-person conventions — I may be one of the few left,” said Barbara L. Boxer, a former California senator who said she had attended every Democratic convention since 1984. “Look, I like to go shopping in a retail store, too. What’s going to happen to that? When you get used to certain things, they have a certain place in your heart. It makes you feel certain things won’t change. It’s a good feeling.”

But John Del Cecato, a Democratic ad maker who worked for Pete Buttigieg, the former mayor of South Bend, Ind., in the 2020 primary race, said the days of action-packed, colorful conventions with big debates about ideas and candidates were long gone.

“Now it’s a heavily scripted, weeklong TV show that gives your nominee a short-lived bump in the polls, but doesn’t have a real impact on the November election,” he said. “But if we did away with them, we’d miss out on that obligatory moment in each presidential race where we pretend like there’s a real possibility of having a brokered convention.”

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Bush Calls for Unity. Trump Attacks Bush. And Then a Host of Others.

Westlake Legal Group bush-calls-for-unity-trump-attacks-bush-and-then-a-host-of-others Bush Calls for Unity. Trump Attacks Bush. And Then a Host of Others. United States Politics and Government Trump, Donald J Presidents and Presidency (US) Fox News Channel Coronavirus (2019-nCoV) Bush, George W
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WASHINGTON — President Trump had a quick reaction on Sunday after former President George W. Bush called for national unity. He attacked Mr. Bush.

National unity, Mr. Trump made clear, was not on his agenda for the day, even as the death toll from the coronavirus pandemic that has ravaged the country passed 67,000 and tens of millions of out-of-work Americans struggled to get by.

Then he planned to end his day with a long appearance on Fox News aimed not at speaking to the country as a whole but to his political base six months to the day before the November election, headlining a virtual “town hall” on the pandemic at the Lincoln Memorial, named for another previous president who famously once warned that “a house divided against itself cannot stand.”

The messages of the day underscored once again that Mr. Trump does not view the presidency in the same way as its previous occupants, favoring combativeness over conciliation even in times of national crisis. For Mr. Trump, it is a formula that has worked and one that finds him at his most comfortable and confident.

He regularly scorns the notion that he should be more “presidential,” dismissing that concept as weak and boring. But it is at moments like this that his departure from the norms of his office becomes most evident.

Mr. Trump, who spent the weekend at Camp David in his first getaway since most of the nation began locking down in mid-March, seemed peeved at a three-minute video message posted by Mr. Bush that made no mention of the current president but warned against partisanship in a time of peril.

“Let us remember how small our differences are in the face of this shared threat,” Mr. Bush said in the professionally produced video set against music and photographs of medical workers helping victims of the virus and of ordinary Americans wearing masks. “In the final analysis, we are not partisan combatants. We are human beings, equally vulnerable and equally wonderful in the sight of God. We rise or fall together, and we are determined to rise.”

While Mr. Bush never mentioned Mr. Trump’s name, the sitting president clearly took the message as an implicit rebuke. In a Twitter message, Mr. Trump paraphrased a Fox News personality saying, “Oh bye the way, I appreciate the message from former President Bush, but where was he during Impeachment calling for putting partisanship aside.”

Mr. Trump then added in his own voice: “He was nowhere to be found in speaking up against the greatest Hoax in American history!”

Hours later, Mr. Trump went after another predecessor, reposting a tweet from a pro-Trump website accusing Mr. Obama of plotting against him. “Evidence has surfaced that indicates Barack Obama was the one running the Russian hoax,” said the original message retweeted by the president.

Mr. Trump also reposted messages attacking Representative Adam B. Schiff, Democrat of California and the leader of the House managers who prosecuted the president at his Senate impeachment trial this year, and vowing to deny federal money to bail out states that maintain sanctuary policies protecting some illegal immigrants. In a less feisty moment, the president did take time out to post a message praising his golf course in Scotland.

Mr. Bush’s video message was part of a series of videos aired online as part of a 24-hour live-streamed project, “The Call to Unite,” that also featured Oprah Winfrey, Tim Shriver, Julia Roberts, Martin Luther King III, Sean Combs, Quincy Jones, Naomi Judd, Andrew Yang and others.

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Mr. Bush’s office said he had no response to Mr. Trump’s message. “The video was a part of an event called ‘A Call to Unite,’” said Freddy Ford, the former president’s chief of staff. “I hope those covering it will resist the temptation to use it as a call to divide.” Mr. Obama’s office had no comment.

Former President Bill Clinton also delivered a message, speaking into a camera in what looked like a video chat from his home. “We need each other, and we do better when we work together,” he said. “That’s never been more clear to me as I have seen the courage and dignity of the first responders, the health care workers, all the people who are helping them to provide our food, our transportation, our basic services to the other essential workers.”

Mr. Trump has declined to call on his predecessors to help bring the country together during the pandemic. Past presidents made a point of enlisting former occupants of the White House from both parties in times of crisis to demonstrate national resolve and unity.

Mr. Bush recruited his father, former President George Bush, and Mr. Clinton to respond to a devastating tsunami in Asia and then to Hurricane Katrina. Mr. Obama asked the younger Mr. Bush and Mr. Clinton to respond to an earthquake in Haiti.

Mr. Trump, for his part, has dismissed the idea of calling his predecessors for help, either to participate or even to offer advice. “I don’t think I’m going to learn much,” he said when asked about the idea in March. “I guess you could say that there’s probably a natural inclination not to call.”

Mr. Bush has never been a fan of his fellow Republican president. Mr. Trump defeated his brother Jeb Bush for the nomination in 2016 and has criticized the 43rd president’s record repeatedly. Mr. Bush refused to support Mr. Trump that fall, saying he had voted for “none of the above” instead. While disturbed by Mr. Trump’s leadership, Mr. Bush has largely kept quiet since then with a couple of notable exceptions, such as a speech in New York and a eulogy for Senator John McCain that were seen as implicit rebukes of the incumbent.

In his video message on Saturday, Mr. Bush recalled the difficult days after Sept. 11, 2001. “Let us remember, we have faced times of testing before,” he said as images flashed on the screen of him comforting relatives of those killed in the attacks. “Following 9/11, I saw a great nation rise as one to honor the brave, to grieve with the grieving and to embrace unavoidable new duties. And I have no doubt, none at all, that this spirit of service and sacrifice is alive and well in America.”

Mr. Bush also called for compassion, a trait that Mr. Trump has largely eschewed during the pandemic in favor of demonstrating what he considers strength and optimism. “Let us remember that empathy and simple kindness are essential, powerful tools of national recovery,” Mr. Bush said. And he added, “Let’s remember that the suffering we experience as a nation does not fall evenly.”

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Global Backlash Builds Against China Over Coronavirus

Westlake Legal Group global-backlash-builds-against-china-over-coronavirus Global Backlash Builds Against China Over Coronavirus Xi Jinping United States International Relations Trump, Donald J Propaganda Coronavirus (2019-nCoV) Communist Party of China China
Westlake Legal Group merlin_170325123_cd8d9bda-c882-4736-ad63-2b042fee38a9-facebookJumbo Global Backlash Builds Against China Over Coronavirus Xi Jinping United States International Relations Trump, Donald J Propaganda Coronavirus (2019-nCoV) Communist Party of China China

BRUSSELS — Australia has called for an inquiry into the origin of the virus. Germany and Britain are hesitating anew about inviting in the Chinese tech giant Huawei. President Trump has blamed China for the contagion and is seeking to punish it. Some governments want to sue Beijing for damages and reparations.

Across the globe a backlash is building against China for its initial mishandling of the crisis that helped loose the coronavirus on the world, creating a deeply polarizing battle of narratives and setting back China’s ambition to fill the leadership vacuum left by the United States.

China, never receptive to outside criticism and wary of damage to its domestic control and long economic reach, has responded aggressively, combining medical aid to other countries with harsh nationalist rhetoric, and mixing demands for gratitude with economic threats.

The result has only added momentum to the blowback and the growing mistrust of China in Europe and Africa, undermining China’s desired image as a generous global actor.

Even before the virus, Beijing displayed a fierce approach to public relations, an aggressive style called “Wolf Warrior” diplomacy, named after two ultrapatriotic Chinese films featuring the evil plots and fiery demise of American-led foreign mercenaries.

With clear encouragement from President Xi Jinping and the powerful Propaganda Department of the Chinese Communist Party, a younger generation of Chinese diplomats have been proving their loyalty with defiantly nationalist and sometimes threatening messages in the countries where they are based.

“You have a new brand of Chinese diplomats who seem to compete with each other to be more radical and eventually insulting to the country where they happen to be posted,” said François Godement, a senior adviser for Asia at the Paris-based Institut Montaigne. “They’ve gotten into fights with every northern European country with whom they should have an interest, and they’ve alienated every one of them.”

Since the virus, the tone has only toughened, a measure of just how serious a danger China’s leaders consider the virus to their standing at home, where it has fueled anger and destroyed economic growth, as well as abroad.

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In the past several weeks, at least seven Chinese ambassadors — to France, Kazakhstan, Nigeria, Kenya, Uganda, Ghana and the African Union — have been summoned by their hosts to answer accusations ranging from spreading misinformation to the “racist mistreatment” of Africans in Guangzhou.

Just last week, China threatened to withhold medical aid from the Netherlands for changing the name of its representative office in Taiwan to include the word Taipei. And before that, the Chinese Embassy in Berlin sparred publicly with the German newspaper Bild after the tabloid demanded $160 billion in compensation from China for damages to Germany from the virus.

Mr. Trump said last week that his administration was conducting “serious investigations” into Beijing’s handling of the coronavirus outbreak.

He has pressed American intelligence agencies to find the source of the virus, suggesting it might have emerged accidentally from a Wuhan weapons lab, although most intelligence agencies remain skeptical. And he has expressed interest in trying to sue Beijing for damages, with the United States seeking $10 million for every American death.

Republicans in the United States have moved to support Mr. Trump’s attacks on China. Missouri’s attorney general, Eric Schmitt, filed a lawsuit in federal court seeking to hold Beijing responsible for the outbreak.

A Chinese Foreign Ministry spokesman, Geng Shuang, called the suit “frivolous,” adding that it had “no factual and legal basis’’ and “only invites ridicule.”

The suit seems to aim less at securing victory in court, which is unlikely, than at prodding Congress to pass legislation to make it easier for U.S. citizens to sue foreign states for damages.

“From Beijing’s point of view, this contemporary call is a historic echo of the reparations paid after the Boxer Rebellion,” said Theresa Fallon, director of the Centre for Russia Europe Asia Studies, referring to the anti-imperialist, anti-Christian and ultranationalist uprising around 1899-1901 in China that ended in defeat, with huge reparations for eight nations over the next decades. “The party’s cultivation of the humiliation narrative makes it politically impossible for Xi to ever agree to pay any reparations.”

Instead, it has been imperative for Mr. Xi to turn the narrative around, steering it from a story of incompetence and failure — including the suppression of early warnings about the virus — into one of victory over the illness, a victory achieved through the unity of the party.

In the latest iteration of the new Chinese narrative, the enemy — the virus — did not even come from China, but from the U.S. military, an unsubstantiated accusation made by China’s combative Foreign Ministry spokesman, Zhao Lijian.

Chinese diplomats are encouraged to be combative by Beijing, said Susan Shirk, a China scholar and director of the 21st Century China Center at the University of California, San Diego. The promotion of Mr. Zhao to spokesman and his statement about the U.S. Army “signals to everyone in China that this is the official line, so you get this megaphone effect,” she said, adding that it makes any negotiations more difficult.

But in the longer run, China is seeding mistrust and damaging its own interests, said Ms. Shirk, who is working on a book called “Overreach,” about how China’s domestic politics have derailed its ambitions for a peaceful rise as a global superpower.

“As China started getting control over the virus and started this health diplomacy, it could have been the opportunity for China to emphasize its compassionate side and rebuild trust and its reputation as a responsible global power,” she said. “But that diplomatic effort got hijacked by the Propaganda Department of the party, with a much more assertive effort to leverage their assistance to get praise for China as a country and a system and its performance in stopping the spread of the virus.”

In recent days, Chinese state media has run numerous inflammatory statements, saying that Australia, after announcing its desire for an inquiry into the virus, was “gum stuck to the bottom of China’s shoe.” Beijing warned that Australia risked long-term damage to its trading partnership with China, which takes a third of Australia’s exports.

“Maybe the ordinary people will say, ‘Why should we drink Australian wine? Eat Australian beef?’” China’s ambassador, Cheng Jingye, told The Australian Financial Review. Australia’s foreign minister, Marise Payne, dismissed China’s attempt as “economic coercion.”

Even in European countries like Germany, “the mistrust of China has accelerated so quickly with the virus that no ministry knows how to deal with it,” said Angela Stanzel, a China expert with the German Institute for International and Security Affairs.

In Germany, as in Britain, in addition to new questions about the advisability of using Huawei for new 5G systems, worries have also grown about dependency on China for vital materials and pharmaceuticals.

France, which traditionally has good relations with Beijing, has also been angered by critical statements by Chinese diplomats, including a charge that the French had deliberately left their older residents to die in nursing homes. That prompted a rebuke from France’s foreign minister, Jean-Yves Le Drian, and anger from legislators, despite an early reciprocal exchange of medical aid like masks.

Recently, the German government complained that Chinese diplomats were soliciting letters of support and gratitude for Beijing’s aid and efforts against the virus from government officials and the heads of major German companies.

The same has been true in Poland, said the U.S. ambassador to Warsaw, Georgette Mosbacher, in an interview, described Chinese pressure on President Andrzej Duda to call Mr. Xi and thank him for aid, a call the Chinese heralded at home.

“Poland wasn’t going to get this stuff unless the phone call was made, so they could use that phone call” for propaganda, Ms. Mosbacher said.

There is some unhappiness in China with the current diplomatic rhetoric. In a recent essay, Zi Zhongyun, now 89, a longtime expert on America at the Chinese Academy of Social Sciences, sees parallels in the harsh nationalist and xenophobic rhetoric of the Wolf Warriors of today with the period around the Boxer Rebellion against Western influence in China.

Ms. Zi said such reactions risked getting out of hand.

“I can say without a doubt,” she concluded, “that as long as Boxer-like activities are given the official stamp of approval as being ‘patriotic,’ as a long as generation after generation of our fellow Chinese are educated and inculcated with a Boxer-like mentality, it will be impossible for China to take its place among the modern civilized nations of the world.”

Reporting was contributed by Isabella Kwai in Sydney and research by Monika Pronczuk in Brussels.

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Global Race for a Coronavirus Vaccine Intensifies

Westlake Legal Group 02dc-virus-vaccine-facebookJumbo Global Race for a Coronavirus Vaccine Intensifies Vaccination and Immunization United States Politics and Government Trump, Donald J Remdesivir (Drug) Moderna Inc Johnson&Johnson International Relations Gates, Bill and Melinda, Foundation Gates, Bill Food and Drug Administration Fauci, Anthony S Coronavirus (2019-nCoV) China Caplan, Arthur L

WASHINGTON — Four months after a mysterious new virus began its deadly march around the globe, the search for a vaccine has taken on an intensity never before seen in medical research, with huge implications for public health, the world economy and politics.

Seven of the roughly 90 projects being pursued by governments, pharmaceutical makers, biotech innovators and academic laboratories have reached the stage of clinical trials. With political leaders — not least President Trump — increasingly pressing for progress, and with big potential profits at stake for the industry, drug makers and researchers have signaled that they are moving ahead at unheard-of speeds.

But the whole enterprise remains dogged by uncertainty about whether any coronavirus vaccine will prove effective, how fast it could be made available to millions or billions of people and whether the rush — compressing a process that can take 10 years into 10 months — will sacrifice safety.

Some experts say the more immediately promising field might be the development of treatments to speed recovery from Covid-19, an approach that has generated some optimism in the last week through initially encouraging research results on remdesivir, an antiviral drug previously tried in fighting Ebola.

In an era of intense nationalism, the geopolitics of the vaccine race are growing as complex as the medicine. The months of mutual vilification between the United States and China over the origins of the virus have poisoned most efforts at cooperation between them. The U.S. government is already warning that American innovations must be protected from theft — chiefly from Beijing.

“Biomedical research has long been a focus of theft, especially by the Chinese government, and vaccines and treatments for the coronavirus are today’s holy grail,” John C. Demers, the assistant attorney general for national security, said on Friday. “Putting aside the commercial value, there would be great geopolitical significance to being the first to develop a treatment or vaccine. We will use all the tools we have to safeguard American research.”

The intensity of the global research effort is such that governments and companies are building production lines before they have anything to produce.

“We are going to start ramping up production with the companies involved,” Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases and the federal government’s top expert on infectious diseases, said on NBC this week. “You don’t wait until you get an answer before you start manufacturing.”

Two of the leading entrants in the United States, Johnson & Johnson and Moderna, have announced partnerships with manufacturing firms, with Johnson & Johnson promising a billon doses of an as-yet-undeveloped vaccine by the end of next year.

Not to be left behind, the Britain-based pharmaceutical giant AstraZeneca said this week that it was working with a vaccine development project at the University of Oxford to manufacture tens of millions of doses by the end of this year.

With the demand for a vaccine so intense, there are escalating calls for “human-challenge trials” to speed the process: tests in which volunteers are injected with a potential vaccine and then deliberately exposed to the coronavirus.

Because the approach involves exposing participants to a potentially deadly disease, challenge trials are ethically fraught. But they could be faster than simply inoculating human subjects and waiting for them to be exposed along with everyone else, especially as the pandemic is brought under control in big countries.

Even when promising solutions are found, there are big challenges to scaling up production and distribution. Bill Gates, the Microsoft founder, whose foundation is spending $250 million to help spur vaccine development, has warned about a critical shortage of a mundane but vital component: medical glass.

Without sufficient supplies of the glass, there will be too few vials to transport the billions of doses that will ultimately be needed.

The scale of the problem and the demand for a quick solution are bound to create tensions between the profit motives of the pharmaceutical industry, which typically fights hard to wring the most out of their investments in new drugs, and the public’s need for quick action to get any effective vaccines to as many people as possible.

So far, much of the research and development has been supported by governments and foundations. And much remains to be worked out when it comes to patents and what national governments will claim in return for their support and pledges of quick regulatory approval.

Given the stakes, it is no surprise that while scientists and doctors talk about finding a “global vaccine,” national leaders emphasize immunizing their own populations first. Mr. Trump said he was personally in charge of “Operation Warp Speed” to get 300 million doses into American arms by January.

Already, the administration has identified 14 vaccine projects it intends to focus on, a senior administration official said, with the idea of further narrowing the group to a handful that could go on, with government financial help and accelerated regulatory review, to meet Mr. Trump’s goal. The winnowing of the projects to 14 was reported Friday by NBC News.

But other countries are also signaling their intention to nationalize their approaches. The most promising clinical trial in China is financed by the government. And in India, the chief executive of the Serum Institute of India — the world’s largest producer of vaccine doses — said that most of its vaccine “would have to go to our countrymen before it goes abroad.”

George Q. Daley, the dean of Harvard Medical School, said thinking in country-by-country rather than global terms would be foolhardy since it “would involve squandering the early doses of vaccine on a large number of individuals at low risk, rather than covering as many high-risk individuals globally” — health care workers and older adults — “to stop the spread” around the world.

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Given the proliferation of vaccine projects, the best outcome may be none of them emerging as a clear winner.

“Let’s say we get one vaccine quickly but we can only get two million doses of it at the end of next year,” said Anita Zaidi, who directs the Bill and Melinda Gates Foundation’s vaccine development program. “And another vaccine, just as effective, comes three months later but we can make a billion doses. Who won that race?”

The answer, she said, “is we will need many different vaccines to cross the finish line.”

At 1 a.m. on March 21, 1963, a 5-year-old girl named Jeryl Lynn Hilleman woke up her father. She had come down with the mumps, which had made her miserable with a swollen jaw.

It just so happened that her father, Maurice, was a vaccine designer. So he told Jeryl Lynn to go back to bed, drove to his lab at Merck to pick up some equipment, and returned to swab her throat. Dr. Hilleman refrigerated her sample back at his lab and soon got to work weakening her viruses until they could serve as a mumps vaccine. In 1967, it was approved by the F.D.A.

To vaccine makers, this story is the stuff of legend. Dr. Hilleman still holds the record for the quickest delivery of a vaccine from the lab to the clinic. Vaccines typically take ten to fifteen years of research and testing. And only six percent of the projects that scientists launch reach the finish line.

For a world in the grips of Covid-19, on the other hand, this story is the stuff of nightmares. No one wants to wait four years for a vaccine, while millions die and economies remain paralyzed.

Some of the leading contenders for a coronavirus vaccine are now promising to have the first batches ready in record time, by the start of next year. They have accelerated their schedules by collapsing the standard vaccine timeline.

They are combining trials that used to be carried out one after the other. They are pushing their formulations into production, despite the risk that the trials will fail, leaving them with millions of useless doses.

But some experts want to do even more to speed up the conveyor belt. Writing last month in the journal Vaccines, the vaccine developer Dr. Stanley A. Plotkin and Dr. Arthur L. Caplan, a bioethicist at NYU Langone Medical Center, proposed infecting vaccinated volunteers with the coronavirus — the method known as challenge trials. The procedure might cut months or years off the development but would put test subjects at risk.

Challenge trials were used in the early days of vaccine research but now are carried out under strict conditions and only for illnesses, like flu and malaria, that have established treatments.

In an article in March in The Journal of Infectious Diseases, a team of researchers wrote, “Such an approach is not without risks, but every week that vaccine rollout is delayed will be accompanied by many thousands of deaths globally.”

Dr. Caplan said that limiting the trials to healthy young adults could reduce the risk, since they were less likely to suffer serious complications from Covid-19. “I think we can let people make the choice and I have no doubt many would,” he said.

In Congress, Representative Bill Foster, Democrat of Illinois and a physicist, and Representative Donna E. Shalala, Democrat of Florida and the former secretary of the Department of Health and Human Services, organized a bipartisan group of 35 lawmakers to sign a letter asking regulators to approve such trials.

The organizers of a website set up to promote the idea, 1daysooner.org, say they have signed up more than 9,100 potential volunteers from 52 countries.

Some scientists caution that truly informed consent, even by willing volunteers, may not be possible. Even medical experts do not yet know all the effects of the virus. Those who have appeared to recover might still face future problems.

Even without challenge trials, accelerated testing may run the risk of missing potential side effects. A vaccine for dengue fever, and one for SARS that never reached the market, were abandoned after making some people more susceptible to severe forms of the diseases, not less.

“It will be extremely important to determine that does not happen,” said Michel De Wilde, a former senior vice president of research and development at Sanofi Pasteur, a vaccine maker in France.

When it comes to the risks from flawed vaccines, China’s history is instructive.

The Wuhan Institute of Biological Products was involved in a 2018 scandal in which ineffective vaccines for diphtheria, tetanus, whooping cough and other conditions were injected into hundreds of thousands of babies.

The government confiscated the Wuhan institute’s “illegal income,” fined the company, and punished nine executives. But the company was allowed to continue to operate. It is now running a coronavirus vaccine project, and along with two other Chinese groups has been allowed to combine its safety and efficacy trials.

Several Chinese scientists questioned the decision, arguing that the vaccine should be shown to be safe before testing how well it works.

In the early days of the crisis, Harvard was approached by the Chinese billionaire Hui Ka Yan. He arranged to give roughly $115 million to be split between Harvard Medical School and its affiliated hospitals and the Guangzhou Institute of Respiratory Diseases for a collaborative effort that would include developing coronavirus vaccines.

“We are not racing against each other, we are racing the virus,” said Dr. Dan Barouch, the director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a professor at Harvard Medical School who is also working with Johnson & Johnson. “What we need is a global vaccine — because an outbreak in one part of the world puts the rest of the world at risk.”

That all-for-one sentiment has become a mantra among many researchers, but it is hardly universally shared.

In India, the Serum Institute — the heavyweight champion of vaccine manufacturing, producing 1.5 billion doses a year — has signed agreements in recent weeks with the developers of four promising potential vaccines. But in an interview with Reuters, Adar Poonawalla, the company’s billionaire chief executive, made it clear that “at least initially” any vaccine the company produces would have to go to India’s 1.3 billion people.

The tension between those who believe a vaccine should go where it is needed most and those dealing with pressures to supply their own country first is one of the defining features of the global response.

The Trump administration, which in March put out feelers to a German biotech company to acquire its vaccine research or move it to American shores, has awarded grants of nearly half a billion dollars each to two U.S.-based companies, Johnson & Johnson and Moderna.

Johnson & Johnson, though based in New Jersey, conducts its research in the Netherlands.

Paul Stoffels, the company’s vice chairman and chief scientific officer, said in an interview that the Department of Health and Human Services understood “we can’t pick up our research and move it” to the United States. But it made sure that the company joined a partnership with Emergent BioSolutions — a Maryland biological production firm — to produce the first big batches of any approved vaccine for the U.S.

“The political reality is that it be would very, very hard for any government to allow a vaccine made in their own country to be exported while there was a major problem at home,” said Sandy Douglas, a researcher at the University of Oxford. “The only solution is to make a hell of a lot of vaccine in a lot of different places.”

The Oxford vaccine team has already begun scaling up plans for manufacturing by half a dozen companies across the world, including China and India, plus two British manufacturers and the British-based multinational AstraZeneca.

In China, the government’s instinct is to showcase the country’s growth into a technological power capable of beating the United States. There are nine Chinese Covid-19 vaccines in development, involving 1,000 scientists and the Chinese military.

China’s Center for Disease Control and Prevention predicted that one of the vaccines could be in “emergency use” by September, meaning that in the midst of the presidential election in the United States, Mr. Trump might see television footage of Chinese citizens lining up for injections.

“It’s a scenario we have thought about,” one member of Mr. Trump’s coronavirus task force said. “No one wants to be around that day.”

The more than 90 different vaccines under development work in radically different ways. Some are based on designs used for generations. Others use genetic-based strategies that are so new they have yet to lead to an approved vaccine.

“I think in this case it’s very wise to have different platforms being tried out,” Dr. De Wilde said.

The traditional approach is to make vaccines from viruses.

When our bodies encounter a new virus, they start learning how to make effective antibodies against it. But they are in a race against the virus as it multiplies. Sometimes they produce effective antibodies quickly enough to wipe out an infection. But sometimes the virus wins.

Vaccines give the immune system a head start. They teach it to make antibodies in advance of an infection.

The first vaccines, against diseases like smallpox and rabies, were made from viruses. Scientists weakened the viruses so that they could no longer make people sick.

A number of groups are weakening the coronavirus to produce a vaccine against Covid-19. In April, the Chinese company Sinovac announced that their inactivated vaccine protected monkeys.

Another approach is based on the fact that our immune system makes antibodies that lock precisely onto viruses. As scientists came to understand this, it occurred to them that they didn’t have to inject a whole virus into someone to trigger immunity. All they needed was to deliver the fragment of a viral protein that was the precise target.

Today these so-called subunit viral vaccines are used against hepatitis C and shingles. Many Covid-19 subunit vaccines are now in testing.

In the 1990s, researchers began working on vaccines that enlisted our own cells to help train the immune system. The foundation of these vaccines is typically a virus called an adenovirus. The adenovirus can infect our cells, but is altered so that it doesn’t make us sick.

Scientists can add a gene to the adenovirus from the virus they want to fight, creating what’s known as a viral vector. Some viral vectors then invade our cells, stimulating the immune system to make antibodies.

Researchers at the University of Oxford and the Chinese company CanSino Biologics have created a viral vector vaccine for Covid-19, and they’ve started safety trials on volunteers. Others including Johnson & Johnson are going to launch trials of their own in the coming months.

Some groups, including the American company Inovio Pharmaceuticals, are taking a totally different approach. Instead of injecting viruses or protein fragments, they’re injecting pure DNA, which can be put through a process that yields the viral protein. When immune cells encounter the protein, they learn to make antibodies to it.

Other teams are creating RNA molecules rather than DNA. Moderna and a group at Imperial College London have launched safety trials for RNA vaccines. While experimental, these genetic vaccines can be quickly designed and tested.

It is one thing to design a vaccine in record time. It is an entirely different challenge to manufacture and distribute one on a scale never before attempted — billions of doses, specially packaged and transported at below-zero temperatures, to nearly every corner of the world.

“If you want to give a vaccine to a billion people, it better be very safe and very effective,” said Dr. Stoffels of Johnson & Johnson. “But you also need to know how to make it in amounts we’ve never really seen before.”

So the race is on to get ahead of the enormous logistical issues, from basic manufacturing capacity to the shortages of medical glass and stoppers that Mr. Gates and others have warned of.

Researchers at Johnson & Johnson are looking for a way to make a five-dose vial to save precious glass. Whether that can be successful depends on whether tests show that a smaller dose will be enough for a successful inoculation.

Each potential vaccine will require its own customized production process in special “clean” facilities for drug making. Building from scratch might cost tens of millions of dollars per plant. Equipping one existing facility could easily cost from $5 million to $20 million. Ordering and installing the necessary equipment can take months.

Governments as well as organizations like the Gates Foundation and the nonprofit Coalition for Epidemic Preparedness Innovations are putting up money for production facilities well before any particular vaccine is proven effective.

What’s more, some vaccines — including those being tested by the American companies Moderna and Inovio — rely on technology that has never before yielded a drug that was licensed for use or mass-produced.

But even traditional processes face challenges.

Because of staff illnesses and social distancing, the pandemic this spring slashed productivity by 20 percent at the MilleporeSigma facility in Danvers, Mass., that supplies many drug makers with the equipment used for brewing vaccines.

Then, about three weeks ago, the first clinical trials for new proposed vaccines started. Urgent calls poured from customers around the world. Even before the first phase of the first trials, manufacturers were scrambling.

“Demand went through the roof, and everybody wanted it yesterday,” said Udit Batra, MilleporeSigma’s chief executive, who has expanded production and asked other customers to accept delays to avoid becoming a bottleneck.

Even as the world waits for a vaccine, a potential treatment for coronavirus is already here — and more could be on the way.

Remdesivir showed modest success in a federally funded clinical trial, slowing the progression of the disease in some patients. It is currently approved only for severely ill patients and the trial did not show that it would significantly reduce fatality rates.

The F.D.A.’s decision to allow its use comes as hundreds of other drugs — mainly existing medicines that are being used for other conditions — are being tested around the world to see if they hold promise. The F.D.A. said there are currently 72 therapies in trial.

Studies of drugs tend to move more quickly than vaccine trials. Vaccines are given to millions of people who are not yet ill, so they must be extremely safe. But in sicker people, that calculus changes, and side effects might be an acceptable risk.

As a result, clinical trials can be conducted with fewer people. And because drugs are tested in people who are already sick, results can be seen more quickly than in vaccine trials, where researchers must wait to see who gets infected.

Public health experts have cautioned there will likely be no magic pill. Rather, they are hoping for incremental advances that make Covid-19 less deadly.

“Almost nothing is 100 percent, especially when you are dealing with a virus that really creates a lot of havoc in the body,” said Dr. Luciana Borio, a former director of medical and biodefense preparedness for the National Security Council under President Trump.

Antiviral drugs like remdesivir battle the virus itself, slowing its replication in the body.

The malaria drug hydroxychloroquine — which has been enthusiastically promoted by Mr. Trump and also received emergency authorization to be used in coronavirus patients — showed early promise in the laboratory. However, the small, limited studies of hydroxychloroquine in humans have so far been disappointing.

Many in the medical community are closely watching the development of antibody drugs that could act to neutralize the virus, either once someone is already sick or as a way of blocking the infection in the first place.

Dr. Scott Gottlieb, a former F.D.A. commissioner, and others said that by the fall, the treatment picture for Covid-19 could look more hopeful.

If proven effective in further trials, remdesivir may become more widely used. One or two antibody treatments may also become available, providing limited protection to health care workers.

Even without a vaccine, Dr. Borio said, a handful of early treatments could make a difference. “If you can protect people that are vulnerable and you can treat people that come down with the disease effectively,” she said, “then I think it will change the trajectory of this pandemic.”

David E. Sanger reported from Washington, David D. Kirkpatrick from London, Carl Zimmer and Katie Thomas from New York and Sui-Lee Wee from Singapore. Denise Grady and Maggie Haberman contributed reporting.

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