WSJ : Preparing for the Next Pandemic

Preparing for the Next Pandemic
The Covid-19 crisis has clear lessons for what we can do now to stop a future global health emergency

After this, then what? We’ve all run out of words—unprecedented, enormous, heartbreaking—to describe Covid-19, finding ourselves reading so much depressing news while hoping that the curve of infection and death starts to flatten. But the pandemic, or more likely this phase of it, will end, and it is not too early to ask, what happens next? More important, what needs to happen next so that we do not find ourselves in our current situation ever again? I see three key areas that need to evolve to make it less likely that the world will face future pandemics.

Global Governance and Readiness. In 2015, Bill Gates was prescient in pointing out that countries carried out tabletop exercises planning for nuclear war but did not practice thoroughly to get ready for pandemics, especially the most threatening sort of pandemics—those, like Covid-19, spread through the respiratory route. The World Health Organization would be the natural convener of these kinds of preparation exercises. But many countries, especially wealthier ones, are highly skeptical of WHO and the need for cooperation to ensure that the world stays healthy.

The perception—and at times, the reality—is that WHO is slow and bureaucratic. The organization’s need to answer to 194 countries necessarily limits its ability to move nimbly, and expectations for its rapid action are hard to square with the fact that the organization is chronically underfunded.

As a result, the world lacks a shared understanding, or even a shared vocabulary, for pandemic preparedness and cooperation. Just look at the communication of events associated with Covid-19. A “pneumonia of unknown cause” detected in Wuhan was first reported to the WHO office in China on December 31. A month later, WHO declared the outbreak a “public health emergency of international concern,” and then on March 11 declared a “pandemic.”

Despite these announcements, much of the world acted like Covid-19 would not have an impact on their citizens. As evidence to the contrary mounted, despite weeks of warning, it was clear that the U.S. faced this peril with no readily accessible diagnostic tests, no proven therapeutics, no vaccine and a shortage of medical supplies needed by patients (ventilators) and care providers (personal protective gear).

Future leaders must be challenged to do much better. It is essential to develop an early-warning system that closely tracks global disease trends and distributes accurate, real-time information about them. Every country must be able to assess and contribute global health data in nonpolitical ways to maximize the chance of keeping its own citizens healthy. And on the supply front, we need a detailed plan that allows for raw materials and rapid response capability when essential medical supplies and equipment are needed. This means reinstatement of the U.S. Pandemic Response Team within the National Security Council and fully funding the global disease outbreak prevention efforts of the Centers for Disease Control and Prevention (CDC).

The U.S. can draw two broad lessons from the tragic unavailability of the equipment that health care workers need to safely treat coronavirus patients.

First, there is no substitute for federal preparedness when it comes to ensuring a ready supply of personal protective gear. Companies like Apple and Facebook stepped up to donate masks they had stockpiled when California wildfires pushed them to protect their staff, and other private companies were able to leverage their global supply chains to pitch in. As grateful as we should be for these efforts, it’s not the private sector’s job to save us in a public health emergency.

It is the role of the federal government to adequately stockpile and plan for a pandemic. Clear accountability on the National Security Council, matching the authority that already exists for the military procurement and supply chain, would allow asset allocation to the states and regions in greatest need. It would avoid what we see today, with states competing against each other for vital supplies.

Second, the concept of “surge capacity” does not appear to have been part of the planning for ventilators, and current needs massively exceed normal demand. There is not only a lack of supply but also a lack of readiness—parts, established partnerships, training—for quickly manufacturing more machines. No single ventilator company has significant excess capacity, and none can produce large volumes, so federal leadership is needed to maximize the use of available capacity. There is also a clear need for simpler ventilator designs, with standard parts to allow production to scale up quickly.

The U.S. established the Strategic National Stockpile in 2003 as an emergency repository for antibiotics, vaccines and other critical medical supplies, but it has not adequately served its role in this crisis. Covid-19 will focus attention on funding and supplying it properly and planning for distribution. For their part, the governors and mayors making requests for aid today need to be making “just in case” plans for tomorrow, using their experience with Covid-19 to encourage the reform and expansion of the Strategic National Stockpile

Public Health. It is a common complaint that health systems and insurers are too focused on urgent and acute health problems, treating disease rather than investing in prevention. We treat lung cancer but underfund tobacco control, treat opioid addiction without enough work on pain management, and treat babies in intensive care rather than give their mothers adequate prenatal care.

This tendency to address what’s right in front of us rather than preventing what might happen in the future is clear from the numbers. According to the Trust for America’s Health, in 2017, public health represented just 2.5% of all U.S. health spending ($274 per person). That small portion covers prevention, preparedness, wellness and community recovery for all Americans. A pandemic takes full advantage of such underinvestment, especially our failure to make primary medical care widely and easily available.

Good public health means that individuals are far less likely to be struggling with hypertension, obesity or diabetes. People who start out healthier will experience lower rates of morbidity and mortality when infectious disease is spreading. Higher vaccination rates are essential too, since they mean that fewer people will be sick with flu and other preventable infections and occupying precious hospital beds.

Even more important, we must have functional public health departments for essential disease-control efforts like contact tracing and quarantine. While our global governance for public health derives from WHO, the national entity we count on is the CDC and ultimately state and local public health departments.

These agencies have been front and center for our safety in the face of multiple prior infectious threats, from HIV/AIDS to Ebola and Zika. This safety is grounded in public health basics. The essential tool in an epidemic is information: who has the disease and who have they been in contact with?

Surveillance and epidemiology are key tactics in this quest, but critical gaps in our capacity have been clear since Covid-19 hit the U.S. Of greatest impact were the now well-known mistakes in novel coronavirus testing that left the government blind to its spread. This inability to trace the pandemic was exacerbated by the clinical manifestations of Covid-19. Current estimates suggest that 25% of those infected do not have symptoms. Failures in testing and high rates of asymptomatic patients meant that leaders, healthcare providers and decision makers did not know the incidence or prevalence of Covid-19, which is the basic information necessary to effectively contain an epidemic.

Finally, public health must provide expertise in an aspect so far lacking in this pandemic: serologic surveillance. This allows us to ask a second key question: not whether individuals currently have Covid-19 but whether they were ever infected and are now immune. The ability to do such testing would allow us not just to understand the biology and course of Covid-19 but also, potentially, to certify health caregivers and other workers who will not risk acquiring or transmitting the infection.

For future epidemics to be managed more effectively, we must have better information, and that means having well-funded, well-trained and well-prepared public health experts—trained in statistics, epidemiology, and laboratory and clinical medicine—at the CDC and in the states

Innovation. Our ability to tap into scientific innovation may turn out to be one of the success stories in our fight against the pandemic. Since China released the SARS-CoV-2 genetic sequence in early January, countless labs around the world have been working to develop new ways to test, treat and prevent Covid-19.

On diagnostics and testing, scientific innovation is not yet making a difference. Serologic tests for antibodies have lagged behind testing for the disease itself, and despite multiple academic and laboratory successes in viral detection, these advances have yet to improve access to testing, accuracy of results or speed of turnaround. Issues have included inadequately trained staff as well as the availability of testing swabs and testing reagents. Dealing with what might be considered the more mundane aspects of diagnostics is just as important as technical breakthroughs.

A true bright spot in innovation has been the work happening on treatment. Since the novel coronavirus was reported in Wuhan, healthcare providers have been working to repurpose existing medications. Biotech and pharmaceutical companies have fully participated in the early tests. These have included work with anti-viral compounds, such as remdesivir, a compound developed by Gilead Sciences, which failed in treatments for Ebola but have shown promise with some Covid-19 patients; antimicrobials, such as the antimalarial drugs hydroxychloroquine and chloroquine, used together with the antibiotic azithromycin, which have shown mixed results in small trials; and remedies for severe Covid-19, such as the compounds sarilumab from Regeneron Pharmaceuticals and Sanofi, and toclizumab from Roche Holding. This is just a small subset of medications furthest along in their development.

The pursuit of therapies will be further advanced by funding from the newly launched Covid-19 Therapeutics Accelerator (funded by the Bill & Melinda Gates Foundation, the Chan Zuckerberg Initiative, Wellcome Trust and Mastercard), specifically intended to speed up R&D. There is also the FDA’s Coronavirus Treatment Acceleration Program, designed to fully staff and support an accelerated regulatory path for novel therapeutics. Many new approaches to product development are under way, using tactics ranging from artificial intelligence to CRISPR gene-editing.

An example of unprecedented collaboration is the QBI Coronavirus Research Group, involving hundreds of scientists at the University of California, San Francisco. These investigators have found 50 drug candidates that shield proteins that the coronavirus needs to thrive. It is an important model for the future.

In all of these efforts, an essential balance must be struck between the wish to quickly get remedies to severely ill patients and the potential for intolerable side effects. In addition, media hype can lead to treating patients with ineffective medication in the face of better choices. The experience with Covid-19 is a powerful reminder of the importance of conducting excellent clinical trials that generate the proof needed to assure caretakers and patients.

Anyone who studies the Covid-19 pandemic knows that we need a vaccine, and we need one quickly. Yet, even more than diagnostics and therapeutics, a safe and effective vaccine will take time. Both the pace and the breadth of the efforts to produce a vaccine are impressive. The biotech company Moderna was the first to treat a patient with an experimental vaccine only 66 days after the viral sequence was available. Today, WHO lists dozens of vaccine approaches under study.

It is exciting to see how advances in genomics, structural biology and immunology have contributed to more innovative approaches to vaccines. And it is not only small companies who are participating. Johnson & Johnson announced a collaboration with the federal Biomedical Advanced Research and Development Authority and a commitment of $1 billion as well as their manufacturing capacity. Global collaborations for rapidly developing and producing vaccines for Covid-19 include Biogen and VIR Biotechnology, Pfizer and BioNTech, GlaxoSmithKline and Clover Health, and many others.

Perhaps the key organization focusing on long-term preparedness is the Coalition for Epidemic Preparedness Innovations, funded jointly by the Bill & Melinda Gates Foundation, Wellcome Trust, the European Commission and seven nations. Since 2017, CEPI has been working to produce a “plug and play” platform approach for dealing with “Disease X,” a newly emerging epidemic disease such as Covid-19. The concept of a platform technology would enable rapid vaccine development, elicit rapid onset of immunity, and enable production to be scaled up quickly to respond to outbreaks.

This is the way forward—to focus not only on the pathogens we know but on preparing ourselves for the pathogens we don’t expect. Today’s epidemic is a powerful reminder that infectious agents do not respect borders and that global cooperation is essential for dealing with them. Classic public health tools are a must: We cannot control what we cannot understand. And we need to maintain the collaborative and generous spirit that has emerged in response to Covid-19. It may feel like a once in a lifetime experience, but that, alas, is unlikely to be the case.

Saudi Energy Min: Russia was the first country to announce that OPEC+ members ar

Saudi Energy Min: Russia was the first country to announce that OPEC+ members are no longer obligated to cut output, which has lead to increasing supply
- Russia's statements were incorrect, Saudi's oil policy is to work for a balance in oil markets that serves both producers and consumers
- Saudi Foreign Min: Russia's assertion is not true, it was Russia and not Saudi that withdrew from the OPEC+ agreement

FT : Music companies threaten to sue TikTok over copyright

Music companies threaten to sue TikTok over copyright
Universal and others accuse video-sharing app of using their songs without licences

A body representing thousands of music publishing companies, including Universal, has threatened to sue video-sharing app TikTok for copyright infringement.

TikTok has soared in popularity as millions of people upload short clips of themselves on the app, often lip-syncing to music. But some music rights-holders say the Chinese-owned company does not have adequate licences for the songs being used in TikTok videos. These rights-holders are now prepared to wage a legal battle with the Beijing-based company, according to four people familiar with the matter. 

David Israelite, chief executive of the National Music Publishers Association, the industry trade body, told the Financial Times that a lawsuit was a “likely future step” as he estimated that more than 50 per cent of the music publishing market was unlicensed with TikTok.

Universal Music has been in licensing negotiations with TikTok for the past year as the world’s largest music company looks to extract more money from the social media app as its user base balloons. However, Universal Music’s publishing arm still does not have any licensing agreement in place with TikTok. This means that Universal’s songwriters, which includes Billie Eilish, Lady Gaga, Elton John and Taylor Swift, do not get paid royalties when their songs are inserted into TikTok videos. 

The rift comes as TikTok’s influence in music has become more prominent, after the smash hit “Old Town Road” emerged from the short-form video app last year. TikTok’s parent company, ByteDance, has been valued at $75bn and is reportedly planning to go public. ByteDance’s investors include SoftBank and Sequoia Capital. 

Universal Music Publishing is seeking payment for lost royalties in any licensing deal and has given TikTok a deadline of this weekend to respond to their latest proposal, according to people familiar with the matter. Universal is weighing legal action if TikTok does not respond, these people added. 

“This level of blatant infringement is something that is rarely seen at this scale by a large multinational company,” said one person close to the talks, likening TikTok’s actions to that of Napster. “We feel that we’ve exhausted those [negotiation] efforts. As a last resort, we turn to litigation.”

A TikTok spokesperson said: “We are proud to support the music industry with the thousands of licenses that we have in place. The details of any agreements or discussions between TikTok and our partners are confidential.”

The NMPA, which represents music publishers and songwriters in the US, has previously sued companies including Peloton, Spotify and YouTube, often winning settlement money. Spotify in 2016 agreed to pay about $30m for unpaid royalties to songwriters. Earlier this year Peloton settled with the NMPA for an undisclosed amount of money. 

In the music business, copyrights are dealt with separately on the recorded music side, which represents the actual tracks, and the publishing side, which covers the songwriting. 

Billboard, the trade magazine, on Wednesday reported that TikTok had struck short-term licensing deals with the major record labels: Universal, Sony and Warner. However, Universal Music’s agreement with TikTok, which covers the recorded side of its music, only covers a fraction of its catalogue and expires soon, according to three people familiar with the matter.

Online streaming has revived the music business, funnelling billions back to the big music labels. These companies fiercely protect their share of the streaming riches through high stakes licensing negotiations with Spotify, Apple, Google, and others. 

ByteDance is separately in talks with the music companies to include their songs in a paid music streaming service, called Resso, which the company has launched in India and eventually wants to expand to the US and other territories.

DailyBeast : Kushner’s Claims About National Stockpile Contradicted by Trump’s O

Kushner’s Claims About National Stockpile Contradicted by Trump’s Own Administration
CHECK THE TAPE
The Trump administration itself has dipped into the federal reserves to help states in need despite Kushner’s claim it is not meant for state use.

President Donald Trump’s top adviser and son-in-law Jared Kushner insisted on Thursday that the government had not built up a national stockpile of medical equipment for states to use during threats like the coronavirus since those states have strategic reserves of their own.

The remark drew raised eyebrows from experts, considering presidents have dispersed supplies from the national strategic stockpiles for use by states dozens of times over the last twenty years. In fact, the Trump administration itself has dipped into the federal reserves to help states in need. Most notably, in 2017, the administration used the stockpile to send materials such as beds and medical equipment to states ravaged by Hurricane Harvey.

That Kushner either didn’t recall this or had deliberately glossed over it sparked additional questions about Kushner’s suitability to play a leading role in the administration’s response to the coronavirus threat.

“He doesn’t know what the hell he is talking about. He has no idea,” said Gen. Russel Honore, a retired military general who helped direct the response on the ground during Hurricane Katrina. “He must have remembered something from some slide or some speech. But that’s why people created the national strategic stockpile in the first place. It’s for those days when we can’t predict what we need. What I see is a total misunderstanding by the White House that they have a responsibility to help maintain the stockpile and help states.”

Kushner’s comments came during a rare appearance before the press corps and as he is taking on a more prominent role in the administration’s response to the global pandemic. In particular, the president’s son-in-law is helping coordinate filling the gaps in the supply chain by trying to gather data on who needs what medical supplies and procuring that equipment so nurses and doctors have what they need to save lives. Kushner and other top Trump officials, including White House adviser Peter Navarro, have put together a group of officials within the larger coronavirus task force to try and pool resources from the private industry and U.S. health distributors overseas. But states are still not receiving the vital medical supplies —such as masks and ventilators—that they need to handle the surge of coronavirus patients.

When asked about Kushner’s remarks on Friday, President Donald Trump exploded at the reporter posing the question, saying they should be “ashamed.”

“You know what ‘our’ means? United States of America, that's what it means,” Trump said. “He said our and our means for the country and our means for the states because the states are a part of the country.”

While state governments do possess their own stockpiles of equipment and supplies, the national strategic stockpile was originally designed in 1999 to help states fill the gaps when facing things like natural or health disasters. The role of the stockpile has expanded dramatically in recent years amid more frequent natural disasters.

But the Trump White House’s approach to filling the supply chain gaps has been slapstick at best, officials say, in part because it was unprepared for taking the lead in responding to a global pandemic. For weeks, the administration struggled to understand which agency was responsible for studying the supply chain breakdown and which was in charge of fixing not only the dwindling medical supplies in hospitals, but also the shortages of products like toilet paper and paper towels in grocery stores.

“We missed dealing with this disaster because for weeks, the White House said it was a hoax,” Honore said. “So we missed at least four weeks of anticipation and preparation on the logistics side because of our leadership.”

The White House, with the help of the Department of Health and Human Services, tried to lead the government’s response to the coronavirus, reaching out to other federal agencies to take over only in certain circumstances. It wasn’t until March 18 that the Federal Emergency Management Agency (FEMA) —an agency with a regional response structure—took over. By that time, weeks had passed before the Trump administration had a clear plan in place to get states what they needed quickly.

“It shouldn’t be this complicated,” said Juliette Kayyem, a former assistant secretary of the Department of Homeland Security. “It’s supposed to happen like a light switch you flip on. And this should have happened a month ago. This is not inventing a vaccine, this is just shipping stuff. In these situations you want a light White House touch and you want the subject matter experts to take the lead.”

It appears the administration is still scrambling to catch up. Officials inside the coronavirus task force told The Daily Beast that the data gathering on the supply chain issues had become so disjointed that the White House turned outward for help. This week the National Association of Manufacturers announced that it would survey private sector companies on medical supplies and equipment, including personal protective equipment and test kits, and would report the data back to the federal government.

According to federal data, the administration has indicated only eight times in it’s contract awards since Jan. 1 that it was procuring medical supplies for the national stockpile. The contracts were doled out by the Office of the Assistant Secretary for Preparedness and Response at HHS to 3M, W.W. Grainger, an industrial supply company, and C.H. Robinson, a logistics and supply company. The awards were for things like coveralls and masks and added up to about $1.6 million.

During his appearance, Kushner was pressed as to why the administration didn’t have more ventilators, facemasks, and other PPEs in its stockpile—as several government bodies and medical experts have warned for years that a flu pandemic would potentially ravage the country.

“The notion of the federal stockpile was it's supposed to be our stockpile. It's not supposed to be states' stockpiles that they then use,” Kushner replied. So “we're encouraging the states to make sure that they're assessing the needs, they're getting the data from their local situations, and then trying to fill it with the supplies that we've given them.”

The answer confounded experts who said it fundamentally misrepresented the purpose of the stockpile, including during the Trump years.

“[Kushner] was wrong,” said Samantha Montano, an expert on emergency management at the University of Nebraska- Omaha. “I don't really know what else to say about it. I don't know where his misunderstanding of what the purpose of the national stockpile (is) comes from. But it's not for just the federal government.”

Kushner's words struck Montano as “horrifying.”

“It demonstrates that they are not only not following the plans that have been in place for how to manage an event like this, but that they are willing to lie to the American public about it and then go change descriptions on websites to try and cover their tracks,” Montano said.

On Thursday afternoon, HHS updated the portion of its website that describes the national strategic stockpile and appeared to alter it slightly to more closely coincide with Kushner’s comments on Thursday.

Katherine McKeogh, a spokeswoman for the Department of Health and Human Services, told Politico in a statement Friday the revisions were in progress before Kushner's appearance at the Thursday briefing.

Wired : Japan Is Racing to Test a Drug to Treat Covid-19

Japan Is Racing to Test a Drug to Treat Covid-19
Based on a compound discovered in 1998, the antiviral Favipiravir is already being used in Japan and Turkey. Its maker? A subsidiary of Fujifilm.

IN LATE FEBRUARY, executives at Fujifilm’s Tokyo headquarters scrambled to coordinate with a team of 100 employees who would be responsible for a task unprecedented in its 86-year history: Japan’s health minister, Katsunobu Kato, had enlisted the camera and imaging company’s help to fight Covid-19. At that point only some 130 people in the country were infected. But a pandemic was in sight.

With the outbreak spreading fast and no vaccine or treatment on the horizon, Kato hoped to find an existing drug that could be used to treat the wave of patients that was sure to come. One candidate was an anti-influenza drug called Avigan, which had been developed decades earlier by the Fujifilm subsidiary Toyama Chemical.

In the weeks that followed, the Fujifilm team managed more than some governments could claim to have done in response to the spread of Covid-19: Working from different offices and factories, members of the group made contingency plans for ramping up production of the drug, advised clinical researchers throughout Japan, and helped get the drug to hospitals where its use had been approved by the government as an emergency measure to treat dozens of Covid-19 patients. On March 28—last Saturday—Prime Minister Shinzo Abe told reporters that his government had begun the formal process for designating Avigan as Japan’s standard treatment for Covid-19.

A critical step in that process involves clinical trials, one of which will conclude at the end of June. And while there is not yet any detailed data supporting Avigan’s effectiveness as a Covid-19 treatment, there are some reasons for optimism. One of them arrived on March 17, when Zhang Xinmin, an official at China’s ministry of science and technology, said that Favipiravir, the generic version of Avigan, had proved to be effective in treating Covid-19 patients at hospitals in Wuhan and Shenzhen.

It was, Zhang said, “very safe and clearly effective” for treating Covid-19 patients. And while the data and methodology behind Zhang's claims have not been made public, he did announce some of the conclusions doctors had drawn from them: At a hospital in Shenzhen, Zhang claimed Covid-19 patients treated with Favipiravir tested negative for the virus after a median of four days, rather than the 11 days it took for members of the study’s control group to test negative; in another study carried out in Wuhan, patients taking the drug allegedly recovered from fever nearly two days earlier than those who did not take the medication.

Such results, preliminary and unconfirmed as they are, would seem to conform with the way Favipiravir works. Unlike most other influenza treatments, which inhibit the spread of the virus across cells by blocking the enzyme neuraminidase, Favipiravir works by inhibiting the replication of viral genes within infected cells, thereby mitigating the virus’s ability to spread from one cell to another.

What this means, in practical terms, is that patients who take the drug while their viral load is low or moderate may prevent it from making them any sicker. And there is some evidence that Favipiravir can achieve these same effects in viruses other than influenza. Prime Minister Abe seems to be among the believers, and last weekend announced that Japan will “start to boost production and proceed with clinical research in cooperation with those countries that wish to join us.” He also said that many countries had already expressed an interest in the drug.

Though Abe did not mention any of those countries by name, one of them seems to be the United States. According to a recent report in Politico, Fujifilm has discussed with the FDA and the US Department of Health and Human Services the possibility of Avigan trials in the US, and it is seeking research funding from the US government. After Abe spoke to President Trump by phone about Avigan, the report says, the White House National Security Council began pressuring the government to accept a donation of Avigan from Japan, and asking the FDA to authorize its use on an emergency basis.

IN LATE 2014, Favipiravir was deployed as an emergency treatment in West Africa, where an Ebola outbreak of unprecedented duration and scale was killing thousands of people. With the support of the W.H.O., Doctors Without Borders offered the drug to a broad swath of infected patients on a compassionate use basis, provided that they were not pregnant, since Favipiravir can cause serious birth defects.

A study concerning its use in Guinea showed promising, though not definitive, results: When administered to patients with low to moderate viral loads, Favipiravir cut Ebola’s mortality rate in half, from 30 percent to 15 percent. Now, five years on, Japan’s government is hopeful that it will have similarly promising results against Covid-19, which had killed 61 of the 2,617 people who had tested positive for the virus in the country as of April 3.

Fujifilm has refused to comment on China’s claims about Favipiravir—it was not involved in the clinical trials carried out in China, which relied on drugs produced by its former manufacturing partner, Zhejiang Hisun Pharmaceutical, which has been China’s main producer of Favipiravir since Fujifilm’s patent on the drug expired there last year.

The company received government approval to manufacture the drug for new and recurring influenza in mid-February, as well as approval for starting clinical trials to determine its efficacy against Covid-19. By late March, once trials had concluded, China had begun exporting Favipiravir. In Turkey, health minister Fahrettin Koca said a shipment of the “special drug” from China was being used to treat Covid-19 patients in 40 different cities.

Japan, too, seems to have recognized Avigan’s utility as a tool of soft power. Three days after Zhang announced that the drug had been effective in clinical trials in China, Indonesian President Joko Widodo told reporters he’d imported 5,000 doses of Avigan, and that he was “in the process of ordering two million more.” This highlights the tension between hope and science in the battle to save lives from Covid-19—while not yet officially Japan’s go-to treatment for the novel coronavirus, Avigan has been successfully used to treat dozens of Japanese patients, according to Prime Minister Abe.

And while Japan’s government is waiting on the results of its own clinical trials before deploying the drug on a mass scale domestically, it seems willing enough to let countries like Indonesia roll the dice on it.

Indonesia is not the only country that would be trying its luck—Fujifilm told me a number of other countries have made inquiries or requests for Avigan, but the company declined to name them and won’t say how much of the drug they will be exporting.

Favipiravir is not the only existing drug to be put forward as a potential Covid-19 treatment. A study published in the New England Journal of Medicine in March showed that the HIV drug Kaletra failed to produce better results than standard care when administered to Covid-19 patients in Wuhan over a period of 14 days. Remdesivir, an experimental antiviral drug developed by biotech giant Gilead, is the subject of two clinical studies in China, which are supposed to yield results in late April. Meanwhile, a clinical trial is now underway in Italy, Spain, Germany, France, and elsewhere to test the efficacy of Kevzara, a rheumatoid arthritis treatment that some believe may calm an overactive immune response that in some Covid-19 patients can damage lung tissue even after much of the virus has passed from the body.

Perhaps the most controversial Covid-19 treatment so far has been the combination of Hydroxychloroquine and Chloroquine, two anti-malaria drugs first approved by the Food and Drug Administration more than six decades ago. On March 21, President Donald Trump sent a tweet endorsing their use as a Covid-19 treatment, citing a French study which involved only 42 patients. Days later, an Arizona man who watched Trump’s televised briefings—where he also enthused about the drugs—died after ingesting Chloroquine, a fish tank additive which he confused for the malaria drug. (A statistically insignificant study published in the Journal of Zhejiang University found Hydroxychloroquine to be no more effective than conventional treatment.)

MEDICINES, LIKE PEOPLE, sometimes take unusual routes to get wherever it is they are going. When Toyama Chemical began working with virologist Kimiyasu Shiraki to develop a new anti-viral compound in 1990, the company had in mind a treatment for herpes. Eight years later, the company shifted gears after Shiraki instead stumbled on a compound that showed promise as an influenza treatment. Toyama Chemical worked to perfect the drug, dubbed Favipiravir, even as the cash-strapped company sold part of its shares to a different pharmaceutical company in 2002. When Fujifilm acquired the company in 2008, the camera and imaging company was keen to move forward with the drug’s development.

During years when its longtime rival Kodak inched closer to Chapter 11 bankruptcy (which it filed for in 2012), Fujifilm diversified its operations. Health and medicine, which now account for 20 percent of the company’s overall sales, is a particularly attractive market in Japan, where more than one-fourth of the population is 65 or older. In 2014, Japan’s Pharmaceuticals and Medical Devices Agency finally approved Favipiravir, which was put to the test against the Ebola virus later that same year in West Africa.

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Among those researchers who studied Favipiravir’s efficacy against Ebola was Xavier Anglaret, who worked as part of a team from Inserm, France’s National Institute of Health and Medical Research, as they conducted two clinical trials and one cohort study in Guinea starting in late 2014. His team was rushed there from Côte d’Ivoire, where they had spent the previous 20 years conducting clinical trials, starting with HIV in the early 1990s.

On Friday, when I spoke with Anglaret by phone, he told me he sees some “striking parallels” between the Covid-19 outbreak and what he witnessed during his time in Guinea. “Of course both diseases are not the same but for us—for researchers and physicians—the challenge is almost the same,” Anglarat tells me from his office in Bordeaux, France.

That challenge, he says, was to set up in just days or weeks clinical trials that might answer important questions about whether or not existing drugs can effectively treat Covid-19. The big difference this time around, he said, was the globalization of the current pandemic. “We are all overwhelmed by what is happening in our own countries,” he says. “We are working 20 hours a day.”

For Anglaret, these long hours have been spent trying to set up a trial in France to assess the efficacy of certain existing drugs in homebound Covid-19 patients over the age of 65. One of the drugs they’ll be testing is Favipiravir, for the same reasons that they tried it against Ebola in Guinea: It’s easy to administer at home, even for old people, and it’s an antiviral potentially effective against a wide spectrum of viruses.

Along with the familiar yellow pills, Anglaret has encountered some familiar challenges, including shortages of equipment and materials. “There are some difficulties that look like what we knew in Guinea,” he says. “It’s very strange to see this in French hospitals, I didn’t think it could happen.”

Still, he says, the conditions of care in French hospitals are much higher than those in West Africa. What could happen there in days to come, he says, is “much, much more terrible.”

FT : Zoom admits user data ‘mistakenly’ routed through China

Zoom admits user data ‘mistakenly’ routed through China
Videoconferencing app under pressure over security and privacy issues

Zoom, the videoconferencing app that has become wildly popular during the coronavirus crisis, admitted that it had “mistakenly” routed some user data through China, marking the latest in a string of mis-steps to cast doubt on the security of the platform. 

The Silicon Valley company — which has been used by the British government, among others, to host meetings during the pandemic — said late on Friday that certain meetings held by its non-Chinese users may have been “allowed to connect to systems in China, where they should not have been able to connect”.

The company said it had “mistakenly” allowed the calls to flow through its two Chinese data centres since February as part of its efforts to cope with increased traffic, as millions of users flocked to use its technology to host business meetings and social catch-ups during lockdown. 

The company said it had since fixed the flaw, adding that the error occurred only “under extremely limited circumstances” and that government customers were not affected. 

Zoom has significant operations in China, including a research and development department with more than 700 staff, which it has cast as a bid to keep personnel costs low. 

Until now it has sought to reassure western critics who have privacy concerns — including that meetings may be vulnerable to spying from Beijing — that their data was not routed through Chinese servers. 

On Thursday the company had told the Financial Times that “data originating in the US stays in the US, and cross-border meeting data goes to wherever the host’s enterprise account is headquartered”. It also said at the time that it only had one data centre in China, not two. 

Zoom floated in April last year and now has 200m daily active users, up from 10m at the end of year. Its shares have nearly doubled in 2020, although they are trading down 20 per cent a highs last week of $128.20. 

The China revelations are the latest in a litany of concerns about the data security practices of the company, which on Thursday committed to shifting all its engineering resources to tackling privacy issues. 

Mis-steps revealed in recent days include undisclosed data sharing, features that allowed users to harass other users, and misleading statements about its encryption capabilities — all of which it has sought to address with technology or policy updates.

It also announced plans to prepare a transparency report about any data requests it has received from governments, following pressure from privacy advocacy groups.

Friday’s statement was prompted by new research from Citizen Lab, which found that in some cases, Zoom’s encryption keys — the code used to unscramble meetings data — appeared to be being sent to servers in Beijing. 

“A company primarily catering to North American clients that sometimes distributes encryption keys through servers in China is potentially concerning, given that Zoom may be legally obligated to disclose these keys to authorities in China,” Citizen Lab said. 

Citizen Lab said that the app was a “high priority target” for intelligence gathering and hacking by nation states, and warned that it should not be used by parties sharing sensitive information. 

“An app with easily identifiable limitations in cryptography, security issues, and offshore servers located in China which handle meeting keys presents a clear target to reasonably well-resourced nation state attackers, including the People’s Republic of China,” the report said.

NYT : In Italy, Going Back to Work May Depend on Having the Right Antibodies

In Italy, Going Back to Work May Depend on Having the Right Antibodies
Weighing an idea that might once have been relegated to science fiction, Italy once again finds itself in the unfortunate vanguard of Western democracies grappling with the coronavirus.

ROME — There is a growing sense in Italy that the worst may have passed. The weeks of locking down the country, center of the world’s deadliest coronavirus outbreak, may be starting to pay off, as officials announced this week that the numbers of new infections had plateaued.

That glimmer of hope has turned the conversation to the daunting challenge of when and how to reopen without setting off another cataclysmic wave of contagion. To do so, Italian health officials and some politicians have focused on an idea that might once have been relegated to the realm of dystopian novels and science fiction films.

Having the right antibodies to the virus in one’s blood — a potential marker of immunity — may soon determine who gets to work and who does not, who is locked down and who is free.

That debate is in some ways ahead of the science. Researchers are uncertain, if hopeful, that antibodies in fact indicate immunity. But that has not stopped politicians from grasping at the idea as they come under increasing pressure to open economies and avoid inducing a widespread economic depression.

The conservative president of the northeastern Veneto region has proposed a special “license” for Italians who possess antibodies that show they have had, and beaten, the virus. The former prime minister, Matteo Renzi, a liberal, has spoken about a “Covid Pass” for the uninfected.

Prime Minister Giuseppe Conte said that while the lockdown remained in place, the government had begun working with scientists to determine how to send people who have recuperated back to work.

With its echoes of a “Brave New World,” the debate about how to reopen arrived in earnest this week in Italy. Like the virus’s crushing toll — some 14,681 dead in Italy as of Friday evening — the shift is ahead of countries like Spain, Britain and the United States, where the contagion is still on an upswing.

Italy was the first European country to announce a nationwide lockdown, which it began on March 9. But the rate of new infections slowed this week — on Friday, there were about 4,500 new cases, less than in recent weeks — leading officials and emergency medical workers alike to talk with guarded optimism.

“We are beginning to see the light at the end of the tunnel,” said Fabio Arrighini, a supervisor of an ambulance hotline in the Lombardy town of Brescia, which has one of the highest death rates in Italy. “The calls have gone down.”

But the debate over an antibody-based work force has once again placed Italy at the unfortunate vanguard of Western democracies grappling with the virus, its uncomfortable ethical choices and inevitable aftermath. Such questions have already been raised by the wrenching decisions of doctors to treat the young, with a better chance of life, before the old and sick.

But at some stage, nearly all governments will have to strike a balance between ensuring public safety and getting their countries running again. They may also find themselves weighing what is best for society against individual rights, using biological criteria in ways that almost certainly would be rejected absent the current emergency.

“It looks like it splits humanity into two, the strong and the weak,” said Michela Marzano, a professor of moral philosophy at the Paris Descartes University. “But this is actually the case.”

From an ethical perspective, she argued, the question of using antibodies as a basis for free movement reconciles a utilitarian vision of what is best for society with respect for individual humanity by protecting “the most fragile, not marginalizing them.”

“It’s not discriminating,” she said. “It’s protecting.”

Scientists in Italy, like their counterparts in Germany, the United States, China and beyond, are already studying whether antibodies are a potential source of protection or immunity from the virus.

China has slowly reopened its economy, focusing on preventing another wave of infection arriving from overseas. In New York, Gov. Andrew M. Cuomo has envisioned a strategy in which younger people, and people who have antibodies showing they have been cured of the virus, can go back to work.

The British government has floated the idea of “immunity passports,” though it is still struggling to complete even swab tests for an accurate snapshot of current infection levels, and the virus has not been present long enough in the British population to provide enough antibody data.

Italy, by dint of its early and widespread exposure to the virus, has an opportunity to gain insight into how the virus works and the biological properties that protect against it.

Next week, Veneto plans to begin collecting 100,000 blood samples from people across the region — first from thousands of health care workers and then public employees — to study in labs the antibodies of people who have the virus and those who have healed from it.

Nowhere in Italy is the pursuit of the antibody strategy more intense than in Veneto. With its wealth of resources, high-profile consultants and biotech presence, it may now be uniquely positioned to influence the global conversation and provide insights for the rest of the world.

The region sits adjacent to the hard-hit Lombardy region, and one of its towns, Vo’, had Italy’s first fatality from the virus and was one of the first towns in the country to be quarantined.

Vo’ also has a relatively homogeneous genetic pool, which may facilitate research, and it has been widely tested. After the outbreak, officials there took the extraordinary step of swab-testing the entire population of 3,000, including people without symptoms.

That helped eliminate an outbreak, and now officials plan to carry out antibody testing and genome sequencing on the entire population to try to detect patterns in who was and was not susceptible to the virus.

Those results, expected in three or four months, perhaps could shed light on why some remained asymptomatic while others got sick, whether those who didn’t get infected already had antibodies and whether children had something that helped them avoid sickness.

“Italy has at the moment, of course, one of the largest pools of infected people that have recovered from the infection,” said Andrea Crisanti, the top scientific consultant on the virus in Veneto and a professor of microbiology at the University of Padua. He added that it was “a unique and valuable set of information and data.”

Dr. Crisanti emphasized the need for a carefully designed strategy to unlock Italy that would make use of contact tracing, protective gear and aggressive testing of post-virus antibodies.

“The planning ahead is one of the most important things,” Dr. Crisanti said. “Because it’s easy to lock down.” Without a proper strategy for the path ahead, “the most likely outcome is that the epidemic starts again.”

Scientists in Italy said the virus produces two types of antibodies, a first that usually appears within five to six days after exposure to the virus, and which fades after 20 days. As a person heals, that antibody, which indirectly shows contagion, is slowly replaced by another antibody, which indirectly shows that a person has had the virus.

When only the second antibody is detected, it means the person is probably no longer infected.

“You are most likely a healthy person that either survived the infection or you were asymptomatic and you have developed antibodies,” Dr. Crisanti said.

In Veneto, the regional president, Luca Zaia, has expressed concern about a single case of “a person who got better and got reinfected,” but he and his consultants appear confident about the potential of antibodies.

The antibodies in healed Italians could be a valuable tool in determining who could safely exit quarantine to work, Dr. Crisanti said.

He argued that the small town of Vo’ presented ideal conditions for antibody and genome testing.

“The good thing about Vo’ is that this is a community that has been in place for several hundreds of years and with probably very little mixing,” he said, giving a clearer genetic picture.

Giuliano Martini, the mayor of Vo’, said that he and the people in his town were grateful for the aggressive testing, which potentially saved hundreds of lives.

Once the central government in Rome lifted an initial quarantine on Vo’ in the beginning of March, Mr. Martini said, the comprehensive testing identified people who were infected but asymptomatic and kept them from spreading the disease.

Putting the town at the disposal of researchers looking to learn more about the virus and its antibodies is “the least we can do,” he said.

“We have to recognize this effort done for us by making ourselves available for future tests,” he said, adding that the town continued to be a gold standard in Italy for active surveillance, and that “we know the name and surname” of all the people who remain in quarantine.

For residents reluctant to take part in the new study, which he acknowledged was more intrusive as it was a blood test, he said, “We go see them in their homes and convince them.”

“There isn’t going to be any problem for this second test,” he said. “It’s an additional check on them, it can’t be anything but positive.”

But the outcomes may not be great news for individuals who, potentially under the law, will remain marginalized from society.

In Veneto, Mr. Zaia has proposed that Italians in possession of antibodies showing they no longer have the virus could obtain a “license” that allows them to move around the country and work.

Dr. Luisa Bracci Laudiero, an immunologist at the Italian National Research Council, said that the antibodies “should be protective, we all hope they are, but we don’t have the mathematical certainty.”

Because Italy was further along in cases,

she said, researchers are able to track many patients over a long period of time to determine if immunity had developed.

“We find ourselves being a bit of a laboratory,” she said.

WWD : Family, Industry Pay Tribute to Sergio Rossi

Family, Industry Pay Tribute to Sergio Rossi
The footwear designer died at 84 on Thursday, struck by the coronavirus.


MILAN — “Goodbye Maestro.”

Sergio Rossi’s family thus honored Sergio Rossi on Friday, a day after the legendary footwear designer died in Cesena, Italy, “not without fighting.” Rossi, who was 84, had contracted the coronavirus and had been hospitalized for days in the intensive care unit of the Bufalini hospital in Cesena.

“His is a story of unconditional love for shoes, which began in an Italy consumed by World War II, and was transmitted from his artisan father, who had always made bespoke shoes,” said the family in a moving tribute, led by his son Gianvito Rossi. “At the age of 14, he was a skilled shoemaker and together with his brother Franco during the winter he produced the shoes he would later sell in the summer on a kiosk along the Riviera. His talent was soon noticed, and he began a successful journey from a young designer to a great entrepreneur. An extraordinary career that has made San Mauro Pascoli a world capital of luxury women’s footwear.

“His line has combined creative design with a quality achieved by a long work of improvement, tireless and endless. His international rise is marked by collaborations with the greatest fashion icons, including, the most iconic ever, young Gianni Versace. A man who gave all of himself, to the shoe, but also to his community. He wanted to donate the knowledge learned in a lifetime to future generations, transmitting them through Cercal, a school founded with his Sammauresi companions. He has always stood out for his class and his strong, charismatic, generous, courageous character: a natural leader, loved and respected at the same time by his collaborators, with whom, in the long journey of his life he created one big family.

“There are those who have had the good fortune to transform their art into a work and those who have the extraordinary talent of transforming their work into a work of art. Sergio Rossi was this man. A husband, father, grandfather and progenitor of a family that followed his example. The family offers, with love, their last goodbye. With the unquenchable fire of your passion, you taught us that there are no limits for those who love what they do. Goodbye maestro,” the family’s tribute concluded.

Rossi began creating footwear in the Fifties and launched his first namesake collection in 1968. At the same time, over the years he designed shoes for brands including Versace, Dolce & Gabbana and Azzedine Alaïa.

Santo Versace recalled how his brother, Gianni, considered Rossi an artist and a master. “He was an artisan and a genius, his shoes were feminine and made in the highest quality but wearable at the same time,” he said.

Rossi made women’s shoes for Versace for years and Santo Versace recalled fondly the hours-long meetings with Gianni, Sergio and Gianvito, aged 12 or 13. It was work but also a family affair. “Sergio was a hard worker and he loved his family,” he reminisced. “You can say the best things in the world about Sergio. He was a true Romagnolo [from Italy’s Emilia-Romagna region], jovial, a lovely person. He helped build the San Mauro Pascoli footwear hub. And even after he left his company, we stayed in touch, exchanging opinions.”

Rossi left his namesake brand shortly after then-Gucci Group, now Kering, took full control of the company in 2004 (it had first taken a majority stake in the firm in 1999 when Gucci was under the leadership of Domenico De Sole and Tom Ford). European investment fund Investindustrial bought the company in 2015.

“He was a master, it was a great pleasure to have met him. He was our spiritual guide and he is today more than ever,” the brand’s chief executive officer, Riccardo Sciutto, said Friday morning.

Sciutto, who was appointed to the role in April 2016, has over the years paid tribute to the founder of the company and created an archive of more than 6,000 models at the state-of-the-art San Mauro Pascoli manufacturing plant.

Sciutto recalled how moved Rossi was when he visited the archive last Christmas. “He was really surprised that so many of his designs from the Fifties onward were part of the archive. He had never thought of doing it because he had lived those moments, but the archive is an inspiration for us.”

Rossi developed a number of trailblazing styles, such as the Opanca sandal with its curved sole and characteristic heel.

Sciutto said the designer “loved women and was able to capture a woman’s femininity in a unique way. He was never over-the-top, always in good taste. The shoes were always wearable and he was never satisfied until they were perfect. They were not accessories for him. He told me once that he wanted to create the perfect extension of a woman’s leg.”

Andrea Morante, who left his role of chairman of the Sergio Rossi company about a year ago, said “surely the footwear sector loses one of its main protagonists.” The designer, he said, “had a visceral passion for the creation of women’s shoes, increasingly more beautiful, and, especially, also very comfortable to wear. It is also thanks to Sergio Rossi that Made in Italy shoes have become synonymous with quality and elegance.”

“In the small town of San Mauro Pascoli, we are 10,000 inhabitants only and we all know each other,” said Giuseppe Zanotti. “When I was a teenager, there were only model-makers, but Sergio was already a designer and entrepreneur, a true legend for us. The 1970s were the years of the rise of companies like Casadei and Pollini, which were already doing business in Italy and abroad, especially in the USA. Sergio belonged to the generation before mine and he has always been a legend and role model for many of us. He did so much for our shoe district – he started Cercal, a school which trains young students to become professionals in the world of footwear, and that I am proud to be part of along with other renowned shoe companies. I respect and admire Sergio, because he was a pioneer of the shoe industry. He was the first to collaborate with young designers in the late 1970s and early 1980s. A real loss for us and for our industry.”
“When I heard the sad news today I realized that we can’t take life for granted. My heart is with Sergio’s family in this time of sorrow and grief,” said Cesare Casadei, creative director of the Casadei footwear label founded by his parents Quinto and Flora in 1958 in San Mauro Pascoli. “My thoughts and prayers are with them. I remember Sergio as one of my father’s best friends and close neighbors. A strong man with a vision, fair competitor and loyal man. Gianvito and I learned from our fathers the integrity, respect for others and appreciation for what we were given. I am sure that we will all remember Sergio as one of the shoemakers that changed the concept of footwear.”

“Sergio Rossi and I have been friends for our entire life. There was never rivalry but deep respect, harmony and sincerity between us,” said Gimmi Baldinini, president and ceo of storied footwear label Baldinini also based in San Mauro Pascoli and founded by his grandfather with Giuseppe Pollini in 1910. “The Sergio Rossi brand stands for Italian excellence and I will forever remember him with deep love.”

Gianvito Rossi has been building his own successful brand since 2007.

Gianni Dori, who leads the Rodo footwear and handbag family-owned brand, said that when he started in the business in 1972, “there were only two examples we looked up to: Sergio Rossi and Bruno Magli. Sergio Rossi’s style, quality have made the history of Made in Italy’s tradition in shoes.”