Jewish Americans Say They Are Scapegoated For The Coronavirus Spread – NPR

Jewish Americans Say They Are Scapegoated For The Coronavirus Spread – NPR

An African Literary Festival for the Age of Coronavirus – The New York Times

An African Literary Festival for the Age of Coronavirus – The New York Times

May 15, 2020

NAIROBI, Kenya For the novelist Maaza Mengiste, the coronavirus lockdowns and stay-at-home measures that have taken hold around the world have brought back the sense of exile she felt when she and her family fled Ethiopia in the 1970s.

So it was a welcome reprieve when she was asked to participate in and help curate a virtual literary festival focused on connection specifically, between writers of African origin and readers throughout the continent and globe.

I jumped at the chance, she said in a phone interview from Zurich. Doing this online breaks a lot of boundaries that felt insurmountable.

Afrolit Sans Frontieres, a series of hourlong readings and question-and-answer sessions held entirely on Facebook and Instagram, kicked off on March 23 and returned for a second edition in April. A third is scheduled to begin on May 25, to coincide with Africa Day, and a fourth is already in the works. In the face of the pandemic, with countless numbers of book fairs, tours and other literary events canceled or postponed, Afrolit stands out as a gathering where readers for some sessions, hundreds have logged in can hear from authors and talk to them about sometimes difficult or taboo subjects.

The South African writer Zukiswa Wanner, who was inspired to create the festival after watching John Legends at-home concert on Instagram, is determined to use this moment to center the work of African writers. Its like a writing master class and a festival in one, Wanner, the award-winning author of nine books, said in a phone interview from Nairobi.

Writers have included Abubakar Adam Ibrahim of Nigeria, Hemley Boum of Cameroon, Bisi Adjapon of Ghana and Mohale Mashigo of South Africa. In the festivals first edition, novelists read sex scenes from their books, explored the place of intimacy in African cultures and discussed love amid war and displacement. During the second edition, writers reflected on what they wish they were asked, both about themselves and their work.

The Eritrean-Ethiopian novelist Sulaiman Addonia spoke about having an epiphany during a late-evening walk and running home to jot down the title of his most recent novel, Silence Is My Mother Tongue. The Egyptian writer Mona Eltahawy spoke about maintaining bravery and courage in the face of attacks, while the Ugandan novelist Jennifer Nansubuga Makumbi talked about the different mind-sets she gets into when writing a short story versus a novel.

Ishmael Beah, the Sierra Leonean author of the best-selling war memoir A Long Way Gone, wished people would ask him questions about his writing career and less about being a former child soldier. And Mukoma wa Ngugi, the novelist and academic and son of the prominent Kenyan author Ngugi wa Thiongo, topped it all by playing the guitar.

Mengiste, the author of Beneath the Lions Gaze and The Shadow King, sees Afrolit as both a homecoming and an example of what African literary festivals could be. What it has affirmed and reconfirmed for me, in a really wonderful way, she said, is what happens when African writers speak to an audience that doesnt require them to explain ethnographic or sociological questions before they get to talk about creativity.

The writers, she said, didnt have to explain their backgrounds or the colonial histories of their home countries before talking about their work. Rather, the conversations went straight to the topics at hand.

It was wonderful to have that experience, Mengiste said, and I have never had that in any other festival that I have been a part of.

Wanner also wanted to transcend language barriers by involving authors not only from Anglophone countries but also from French, Portuguese and Arabic-speaking parts of Africa. The readings and question-and-answer sessions may happen in any language, or more than one language. Even the festivals name, which combines English and French words, reflects that multilingual approach.

If there was a way I could have thrown Portuguese in the title as well, I would have done that, she said.

The Angolan writer Ondjaki (the pen name of Ndalu de Almeida) said the virtual festival allowed him to connect with writers in a very beautiful, accessible way, he said whom he might never have met except in European or American literary circles. As a writer in Portuguese a language officially spoken in just six out of Africas 55 countries Ondjaki said many Portuguese speakers dont get a chance to access books from other writers in the continent unless they are translated.

Afrolit also pushed him, he said, to start reading writers like Chike Frankie Edozien of Nigeria and Remy Ngamije of Namibia.

For Troy Onyango, a Kenyan writer who moderated some of the Afrolit sessions, the pandemic has meant meditating on the present by trying to understand the past. Part of that includes reading novels like Tsitsi Dangarembgas Nervous Conditions, which explores class, race and gender in pre-independence Rhodesia, now Zimbabwe. It also has meant listening to more experienced writers about the insights to be gained from fiction and nonfiction.

I dont think before Covid-19 we would have imagined a literary festival in our living rooms, Onyango said, and just being able to access whichever writer and being able to ask them questions from the serious ones to the mundane ones.

Last week, Wanner announced that Afrolits third edition will run under the title Future. Present. Past. The fourth, she said, will have the theme of Long Story Short and will exclusively feature poets and short story writers.

Afrolit is free, and Wanner isnt making money from it. She hopes to get funding so that shes able to pay the writers, especially the younger ones who might be working without the safety net of unemployment benefits or health insurance, she said. But if no funding comes through, she said, that doesnt mean she will stop.

This is something that we love and its important that people get to realize there is all this African literature, she said. Africa is writing. Africa is thriving.


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An African Literary Festival for the Age of Coronavirus - The New York Times
The Coronavirus Is Just One Challenge the Navajo Nation Is Facing – The New York Times

The Coronavirus Is Just One Challenge the Navajo Nation Is Facing – The New York Times

May 15, 2020

I was born in the Navajo Nation and raised half on and half off the reservation. Shuttling between my grandmothers ranch in Black Mesa, Ariz., and the small border town of Winslow, I took note from an early age of the vast inequities between those two places.

In Black Mesa, where the clay soil is blanketed with sagebrush and juniper, theres no electricity, running water or paved roads. A typical day began as early as 4 in the morning; we made a corn pollen offering to the holy people, drank some loose-leaf Lipton tea and let the sheep out to graze.

In Winslow, I lived on the north side of the I-40 freeway and appreciated the convenience of having running water, electricity and a school within walking distance. Winslow is a small railroad town where Navajo families do their weekly shopping and laundry, and there is a dormitory for Native American high school students.

Today the Navajo Nation is one of the worst hot spots in the country for Covid-19.

Hundreds of miles of roads are unpaved, so it can take up to three hours to get a sick person to help. Its difficult to self-isolate because families live in one-room homes called hogans. Up to 40 percent of Navajo households dont have running water, making it hard to wash hands. Cellphone service and Wi-Fi are limited, so its difficult to keep in touch and to get information about the epidemic.

It took six weeks after Congress allocated $8 billion for coronavirus relief for the Navajo Nation, along with 573 other recognized Native American tribes, to see any of the money. And so far, 102 people have died.

For Native Americans, the American dream has been a nightmare. I always cringe when I see those Established in signs at the entrances to towns and cities. They erase the history of Indigenous people who managed those lands for thousands of years, before it was stolen, their treaties broken, their families killed. Today you see the results of this trauma throughout Indigenous territories.

The Navajo Nation lies among the four sacred mountains between Colorado, New Mexico and Arizona. We call ourselves Din, the people, in Navajo, and we pray to the mountains for protection and healing. When a Din baby is born, we bury her umbilical cord near her home so that she will always remember where she is from. We have a symbiotic relationship with the hills, mountains, water, plants and animals; they all have names, songs and prayers.

My grandmother is the matriarch of our family. She is from the Salt clan. The Din have clans that help us identify ourselves and our relations to others, a kinship system that we call K. It was through K and our ceremonies that my people survived the attempted genocide of the 350-mile Long Walk from Arizona to the concentration camp at Fort Sumner, N.M., where 8,000 of our people were held from 1864 to 1868 by the U.S. Army.

That year our leaders signed a treaty with the federal government that allowed us to return to our homelands under the condition that we give up any weapons, send our children to school and convert to Christianity. Basically, agree to assimilate.

My grandmother was the only one of her eight brothers and sisters who wasnt sent to a government-run boarding school. Her parents sent her into the mountains with the sheep for days at a time to hide her from the Indian agents who took Din children away from their families. They were healers and wanted one of their children to carry on the traditional ways.

And she has. She supported 10 children by raising sheep and cattle and weaving rugs. She taught her children and grandchildren to be mindful and not take anything for granted.

When I was growing up, to get water for the household, we had to drive an hour to the Peabody Coal Companys mine, where there was a public well. This naturally taught me to respect water and to consume it wisely.

The conditions I was raised in havent changed much. The lack of basic services on the reservation isnt due to our choosing to live this way. Its because treaties and federal policies dictate how we live and have created red tape that makes it hard to get things done.

How is it that the Navajo Nation borders 80 miles of the Colorado River and doesnt have access to one drop of water? How can it be that coal and water from Navajo lands helped create electricity for Los Angeles, Las Vegas and Phoenix, and yet 15,000 families on the reservation dont have power?

Our tribal government was formed in 1923 with the express purpose of completing a business transaction to sign oil lease agreements with Standard Oil. This was the beginning of a system in which corporations could make billions pillaging our homelands for uranium, coal, oil and gas deposits, leaving our groundwater contaminated and our people sickened with uranium radiation exposure, lung disease, asthma and cancer.

Today we dont need handouts from the U.S. government. We need investment in building a restorative economy that is aligned with our traditional values and our relationship with nature.

While interest rates are near zero, we should be investing billions in a Green New Deal for the Navajo Nation to support new infrastructure for clean energy, sustainable agriculture, broadband, education, housing and health care.

The coronavirus has exposed how fragile my home is, but it is also a reminder of what matters. Im grateful to my great-grandparents for their bold action to hide my grandmother. Her wisdom and knowledge of our ceremonies and language has kept us rooted to Mother Earth. She is 95 years old and is a national treasure. Thousands of elders like her are at high risk for this virus, and we are keeping her out of harms way by staying home and wearing masks when we have to go out for food.

Unlike some prominent Republicans who have suggested we could sacrifice our elders to help the economy, we honor our elders and believe all life is sacred.

Wahleah Johns is a founder of Native Renewables, a nonprofit that provides solar energy to tribal communities.


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The Coronavirus Is Just One Challenge the Navajo Nation Is Facing - The New York Times
The race to find a coronavirus vaccine: How other viruses put researchers ahead – CBS News

The race to find a coronavirus vaccine: How other viruses put researchers ahead – CBS News

May 13, 2020

More than 100 potential coronavirus vaccines are being tested at record speeds. Drugmaker Moderna got FDA approval last week to start a second round of clinical trials and Pfizer began human trials of its vaccine candidate in the U.S.

Kizzmekia Corbett, who leads the National Institutes of Health coronavirus vaccine collaboration with Moderna, told CBS News at the start of the outbreak in January that the SARS vaccine gave researchers a huge head start.

It would take just two months to bring their COVID-19 vaccine to human trials.

"We actually changed the genetic code for the spike protein based on our knowledge that we gathered from designing vaccines for other coronaviruses in the past," Corbett told CBS News chief medical correspondent Dr. Jon LaPook.

That spike protein is the key the coronavirus uses to unlock and invade a body's cells. Moderna's vaccine uses genetic material known as messenger RNA to instruct cells to make spike proteins that trigger an immune response to fight the virus.

As one of the first American volunteers for Moderna's trial, 61-year-old Carol Kelly received her first dose in late April. She was told a potential risk was that she might have flu-like symptoms.

"The ultimate bad symptom was I could get really, really sick," Kelly said.

But, with so many people suffering from the coronavirus, Kelly wanted to help.

"I thought, here is an opportunity that just presented itself and I need to do what I can," she said.

At Johnson and Johnson, researchers are using a different approach. They take a piece of coronavirus DNA and place it inside a weakened cold virus, triggering an immune response.

"We have used this so many times before that we know what we have to do in order to get very quickly to a vaccine," said Dr. Paul Stoffels, Johnson and Johnson's chief scientific officer.

Stoffels said the company can have 1 billion doses ready by next year.

Responding to possible concerns that accelerating the vaccine timeline could jeopardize safety, Stoffels said, "It's a biological vector, which has been used a lot in animals and in people ... from small kids to elderly, from people who are healthy to people who are very sick like an HIV, so we have been testing that in a very controlled way already."

Harvard immunologist Dr. Barry Bloom said compressing the process does not mean safety measures are being cut.

"I don't think anybody is thinking about compromising in any manner, shape or form, but we will only know that after the initial safety studies when there's nothing obviously wrong," Bloom said.

But even if there is a successful vaccine by early next year, Bloom said it will likely take several years before enough people are immunized to create widespread protection.

"It's going to make a difference in two to three years, a real difference. And not just in the U.S., but hopefully in many other countries," he said.


Go here to read the rest: The race to find a coronavirus vaccine: How other viruses put researchers ahead - CBS News
First Thing: Is the US holding up the search for a coronavirus vaccine? – The Guardian

First Thing: Is the US holding up the search for a coronavirus vaccine? – The Guardian

May 13, 2020

Good morning,

Scientists are confident that, with a worldwide push, at least one Covid-19 vaccine can be developed and distributed in record time. And, as with the recent multinational efforts to combat Ebola, Zika and HIV, US expertise is likely to play an essential role. So why did Donald Trump suggest last week that the disease is gonna go away without a vaccine?

Tom McCarthy reports on how the US administrations apparent indifference to global efforts could slow the discovery of a vaccine and hinder Americans access to one when it eventually arrives. Trumps incompetent handling of the pandemic is not just endangering US lives, argues Michael H Fuchs, Americas abdication of global leadership is crippling the global response:

Trump does not seem to recognize that the only effective solution to the pandemic is to counter it everywhere. Without a universally administered vaccine, the virus could continue to cycle through country after country. And as desperate as the situation is in the US, other countries could fare far worse.

Trump brought his first press conference since 27 April to an abrupt end on Monday, after a fresh clash with reporters. At the Rose Garden briefing, the president was flanked by signs that proclaimed America leads the world in testing. But when the CBS News correspondent Weijia Jiang asked why he had framed the issue as a global competition on a day when US Covid-19 deaths passed 80,000 Trump replied: Dont ask me. Ask China that question.

The president seemed more keen to focus on his never-ending feud with his predecessor, Barack Obama, who has reportedly expressed disquiet over the Department of Justice dropping its case against Michael Flynn, Trumps first national security adviser. Trump is exceedingly worked up over something he calls Obamagate but cant seem to come up with any details of Obamas alleged crimes.

With parts of New York state preparing to reopen from Friday, and infections back down to the same rate as in mid-March, the governor, Andrew Cuomo, has said he believes the state is now on the other side of the mountain in its struggle against the pandemic. But a CDC analysis has found that the true coronavirus death toll in New York City may be significantly higher than the official count.

Elsewhere in the US

Elon Musk has ordered production to resume at a Tesla factory in northern California, in defiance of the regions lockdown orders.

Volunteers in Florida are scrambling to find new homes for greyhounds after the pandemic shut down the states dog racing tracks.

The family of the first man to die of Covid-19 in Ice custody have spoken to Sam Levin. Carlos Ernesto Escobar Mejia, who had lived in the US for 40 years, succumbed to the disease last week while in detention in San Diego.

The emergencies chief of the World Health Organization, Michael Ryan, has said the gradual lifting of lockdown restrictions in countries that appeared to have slowed their Covid-19 infection rates was a sign of hope, but warned that extreme vigilance will be required as parts of the world reopen.

The leading global cause of death is malnutrition. One in nine people is going hungry, or 820 million people worldwide, according to the Global Nutrition Report 2020. The report was written before the pandemic, and its authors say the crisis is likely to set back efforts to alleviate world hunger.

The US supreme court is tackling Trumps tax returns. The justices will hear arguments on Tuesday as to whether the presidents accountants should have to disclose details of his financial affairs, in cases originating in New York state and with Democrats in Congress.

Interpol issued a red notice for fugitive Anne Sacoolas, an American woman charged in the UK with causing the death by dangerous driving of a 19-year-old motorcyclist, Harry Dunn. Sacoolas fled the UK, claiming diplomatic immunity. The red notice means she risks arrest if she sets foot outside the US.

Emo rapper Yung Lean bares his soul

When he first emerged from his native Sweden, 23-year-old Jonatan Leandoer Hstad aka Yung Lean was considered little more than a novelty act. Nowadays, though, hes revered as an emo-rap pioneer. I was definitely ahead of my time, he tells Rachel Aroesti.

Rutger Bregmans tribute to our better nature

The Dutch historian Rutger Bregmans new book is a history of human nature, which argues that our pessimistic opinion of ourselves is misplaced. Its reassuring and thought-provoking, says Andrew Anthony, even if its view of humanity is incomplete.

The social anxiety of choosing a pandemic pod

Around the world, people are partnering up with other households to create pandemic pods who mix only with each other. It sounds like a lovely idea, writes Poppy Noor, but having only just moved to New York, would it leave her looking a bit too desperate for new friends?

During his basketball career, Kareem Abdul-Jabbar learned the power of a passionate pep talk. If Trump wants the US to come together as a team to fight the pandemic, he needs to deliver one.

It is the speech Trump should deliver, not because he wants to be re-elected, but because it would address the countrys major concerns, end the political squabbling, provide a reasonable plan going forward, and give Americans confidence that their government is working to protect their health and economic concerns. It needs to be the speech of a statesman not a, well, Trump.

If youre fortunate enough to have an outside space during the lockdown, however small, nows your chance to boost its biodiversity. Amy Fleming suggests a few tricks for creating an English-style cottage garden.

First Thing is delivered to thousands of inboxes every weekday. If youre not already signed up, subscribe now.


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First Thing: Is the US holding up the search for a coronavirus vaccine? - The Guardian
Pfizer wants to expand human trials of coronavirus vaccine to thousands of people by September, CEO says – CNBC

Pfizer wants to expand human trials of coronavirus vaccine to thousands of people by September, CEO says – CNBC

May 13, 2020

A logo for Pfizer is displayed on a monitor on the floor at the New York Stock Exchange, July 29, 2019.

Brendan McDermid | Reuters

Pfizer CEO and ChairmanAlbert Bourla said Tuesday that the company plans to expand human trials of its experimental coronavirus vaccine to thousands of test patients by September.

The U.S.-based pharmaceutical giant, which is working alongside German drugmaker BioNTech, injected doses of its potential vaccine, BNT162, into the first human participants in the U.S.last week. The company said it hopes to test up to 360 people in the clinical trial.

Pfizer is currently testing four different vaccine variations, Bourla said during CNBC's Healthy Returns Virtual Summit.

"We are collecting data as we speak in real time so we know, we are monitoring the safety of the doses," Bourla said. Pfizer will have conclusive data on which vaccine variation stands out in June or July, Bourla said.

If one or two variations indicate success, the company will ramp up trials, and then in September launch a broad large-scale study with thousands of participants if a vaccine proves to be successful, he added.

"If things go well, and we feel that the product is safe and efficacious, and the FDA [Food and Drug Administration] and EMA [European Medicines Agency] and other regulatory agencies feel the same, we will be able to deliver millions of doses in the October time frame," Bourla said.

The company plans to produce hundreds of millions of doses in 2021, he added.

There are no FDA-approved therapies to treat Covid-19, and drugmakers are racing to produce a vaccine, which U.S. health officials say is expected to take at least 12 to 18 months.There were more than 100 vaccines in development globally as of April 30, according to the World Health Organization.

CNBC's Berkeley Lovelace Jr.contributedto this report.


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Pfizer wants to expand human trials of coronavirus vaccine to thousands of people by September, CEO says - CNBC
The cyberthreat that could derail the world’s race to develop a coronavirus vaccine – CNBC

The cyberthreat that could derail the world’s race to develop a coronavirus vaccine – CNBC

May 13, 2020

Tolga Akmen | AFP | Getty Images

As people all over the world are adjusting to life during the coronavirus pandemic, a threat has emerged that could potentially interfere with efforts to mitigate the damage. Cybercriminals are attacking pharmaceutical companies, and while these attacks pose a threat to customers' privacy rights, some wonder if they might also interfere with the development of a vaccine.

Sivan Nir, threat intelligence team leader at the cybersecurity company Skybox Security Research Lab, said that many cybercriminals have pledged not to attack health-care providers during the coronavirus outbreak. Pharmaceutical companies, on the other hand, are not so lucky.

"There is a certain amount of 'honor amongst thieves' that exists within cybercriminal communities," she said. "At the onset of the Covid-19 crisis, a number of ransomware operators said that they will no longer be targeting medical or health organizations during the pandemic. This compassionate approach, however, does not extend to pharmaceutical companies."

The pharmaceutical company ExecuPharm was the victim of such an attack in March. The company told the Vermont attorney general's office that the ransomware attack saw driver's licenses, financial information, Social Security numbers and other sensitive patient data compromised and published on the dark web.

ExecuPharm told TechCrunch that a ransomware group called CLOP was responsible, but why would anyone attack a pharmaceutical company in the middle of a pandemic? According to emails between CLOP and the technology security website Bleeping Computer, it's because the ransomware group sees ExecuPharm and other companies like it as profiting from coronavirus, making them fair game.

"We never attacked hospitals, orphanages, nursing homes, charitable foundations, and we won't," CLOP told Bleeping Computer. "Commercial pharmaceutical organizations ... are the only ones who benefit from the current pandemic."

The security challenges facing these companies are compounded by the fact that many now have large remote workforces. According to Mickey Bresman, CEO of the cybersecurity company Semperis, the working-from-home situation exposes organizations to increased risk.

"We're already seeing an uptick in opportunistic cyberattacks around the globe," he said. "Bad actors are using the crisis to launch new phishing, malware and other attacks that exploit public concern over Covid-19."

Chuck White, chief technology officer for the cybersecurity company Fornetix, said that pharmaceutical companies have options when it comes to protecting their data and intellectual property from malicious actors. One is to protect data with the strongest encryption methods available.

"Make sure that the organization is using the maximum strength in algorithms based on what their technology can use," he said. "Have your technology enforce that utilization."

Additionally, he suggested investing in storage technologies that can be secured with encryption and having staff use geofencing, which can provide security for local area networks. He also emphasized making sure everyone in the organization is safeguarding the company's intellectual property and personal data by practicing "cyber hygiene."

"Don't use work equipment for personal reasons," he said. "Browse what you need to do your job, not to learn what your favorite sports team is doing."Pharmaceutical companies may need to implement these practices sooner rather than later. According to Jason Smolanoff, global cyber-risk practice leader at the cybersecurity company Kroll, new attacks are already under way.

"It just happened with a pharmaceutical company that's working on a vaccine," he said. "In this case, it was done by a national actor, and indications are that the intention behind it was to steal trade secrets."

He added that there are four main categories of attackers. These include nation-states that are looking to steal trade secrets; hacktivists who are promoting a social agenda; an insider who works for the company; and financially motivated cybercriminals, who conduct ransomware attacks for financial gain. This last category can create headaches beyond mere financial loss for the victimized company.

"These days, there are different versions of ransomware that encrypt the data and also steal it," he said. "The implication is that if data is stolen, the company has a legal obligation to notify people that their data was stolen."

As for the people who depend on pharmaceutical companies to manufacture their medicines, these attacks pose a personal threat to them as well.

"Patients in clinical studies are the main area of threat," Fornitex' White said. "Though the patient's progress and personal information roll into a pharmaceutical's development of the intellectual property, it is still personal information for the patient at the end of the day. Collateral damage from the pharmaceutical's perspective is possibly devastating for the patient."

He said that pharmaceutical companies could protect patient data by weighing how much of it they need to do their job effectively.

"In the spirit of 'cyber hygiene,' it needs to be the bare minimum," he said. "Things like tokenizing user IDs, not making the information useful for an attacker to sell, or possibly blackmail patients."

Despite CLOP's belief that pharmaceutical organizations should be targeted, Bresman of Semperis said that focusing on their profit motive misses the point. He said that targeting any part of the medical infrastructure at this time threatens the health and well-being of the entire general public.

"When attackers target healthcare and pharma companies, they aren't just hacking databases or defacing websites they can actually put lives in danger, and the global pandemic is raising the stakes dramatically," he said. "When attackers shut down IT networks and disrupt services, the strain on already overwhelmed critical infrastructure compounds. [It] undercuts Covid-19 intervention efforts."

More from Technology Executive Council:An Apple business you may not know that's poised to boom from coronavirus crisisWould you let Google, Apple contact-trace your family? Here's what Reddit's Alexis Ohanian saysGoogle, Facebook, Twitter team up to support addiction recovery during pandemic


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The cyberthreat that could derail the world's race to develop a coronavirus vaccine - CNBC
What’s it like to work on J&J’s coronavirus vaccine? For one scientist, it’s social distancing in the lab, late nights at home – FiercePharma

What’s it like to work on J&J’s coronavirus vaccine? For one scientist, it’s social distancing in the lab, late nights at home – FiercePharma

May 13, 2020

Rinke Bos is a scientist. But under the bright spotlight of COVID-19, the Johnson & Johnson immunologist has also become a media spokesperson, an online video cast member and one of the many pharma researchers who symbolize hope for the world.

Bos leads the J&J vaccine discovery team of about a dozen researchers in the small town of Leiden in her native country of the Netherlands. The teamfirst began designing potential vaccines after the full RNA sequence forSARS-CoV-2 was released publiclyin January. They researched options, performed preclinical testing and correcteddesigns to narrow downcandidates.

The team workeddays, nights and weekends in shifts to build and test 10 different vaccine possibilities. At first, they workedtogether in the lab, but later, after social distancing restrictions went into effectin the Netherlands, they switched to remote workwith only one or at most two people allowed in the lab at the same time. That required some shifts in procedures, such as more detailed note-taking,which becamecritical. Missingspecificsin hand-offs between team memberscould create delays no one wanted.

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

Then, on March 30, J&J announced the result of the discovery teams worka leadvaccine candidate. At the same time, the pharma companypledged $1 billion in partnership with the U.S. Biomedical Advanced Research and Development Authority to develop it.

Its the best feeling that maybe we can contribute to developing a vaccine that might prevent people from getting sick. Especially now that it concerns everybody, Bossaid. The whole world needs a vaccine.

Thats mostly exciting, but of course theres also pressure," Bos added. "When your email inbox grows every time you look away from your computer, thats sometimes a bit nerve-wracking. Everybody has questions, and they'realso in a hurry, so you want to answer as fast as possible, she added.

RELATED:How is COVID-19 affecting drugmakers? J&J execs offer some early clues

J&J opened the vaccine facilitywhere Bos works in late 2018 to advance its then-ambitious plans for several viral vaccine programs including HIV, respiratory syncytial virus, Ebola, Zika and a universal flu vaccine. The 72 million sitewith its laboratories andmanufacturing facilitieswas designed to also support large-scale commercial rollouts for those candidatesand now, it will do that for J&Js COVID-19 vaccine candidate.

While the vaccine discovery team's workload slowed somewhat after the candidate was chosen and moved into preclinical testing, Bos is still operating in overdrive. Normally, the team would wait for clinical data before proceeding, but with the accelerated timeline, all work is being done in parallel, she said.

That means even as Bos and her team wait for the start of the first human trials, planned for September, they're already preparing for global distribution to achieve J&J's goal of one billion vaccines by next year.

RELATED:J&J steps up vaccines R&Dand prepares for launcheswith 72M plant

J&J isnt only aggressively tackling the vaccine challenge, but also widely calling attention to its work and its scientists across digital and social media. In a way, J&J is consumerizing the epidemiology ofCOVID-19, bringing details and progress directly to the public.

Bos herself appeared in the first episode of the J&J original online series Road to a Vaccine, a look behind the scenes with journalist Lisa Ling that now airs live every Tuesday on Facebook, Twitter, LinkedIn and JNJ.com. Other J&J scientists,including Chief Scientific Officer Paul Stoffels and global head of viral vaccine discovery Hanneke Schuitemaker, have also appeared on the show and in media interviews.

On a daily basis, Bos is keptbusy testing and making the material needed to start large-scale productiona fact not gone unnoticed by her three children, ages 7, 9 and 11. Initially they thought it was cool that their mom was working on a vaccine that couldhelp the world, but theyve become less enthusiasticespecially during the recent school break, when they would have preferred a playmate and vacation companion.

She's able to take her children to school every day; in the Netherlands, schools can provide care for children of parents who are working in essential professions. (Her husband is a radiology manager at a local hospital.) Bos also reservesevery evening from 6 p.m. to 8 p.m. for dinner and family time. After bedtime books are read, however, she heads back to her computer for more data analysis, emails and study.

Bos said she's glad to have her children as a distraction to take her mind off work at times and stay mentally healthy.

RELATED:J&J inks 2nd manufacturing deal to boost capacity for COVID-19 vaccineThe

Even outside of this crisis, its always so nice that as soon as you come home, you focus on the kids. You just think about the kids and you forget about work for a while, she said. They also help keep her in shape. Along with going for solo runs when she can, Bos joins her children in the backyard for bouncesessions on the family's trampoline.

Bos in turn tendsto her work team'smental health and well-being, staying in touch withonline video meetings and dropping offfood or treats to say thank you and remind them they have support. Bos said one of the things she's looking forward to is the time when they can work together again in the J&J offices and labs.

J&J scientists on Bos' teamare just a few of the many people atwork inside pharma and research institutions, developing vaccines on previously unimaginable timelines. Pfizer, Sanofi, Moderna and AstraZeneca all have teams working on the more than 70 vaccine candidates beingconsideredfor COVID-19.

While Americans have been told by government officials and through the media that a vaccine might be available in 12 to 18 months, some are skeptical. Influential biopharma analyst Geoffrey Porges of SVB Leerlink recently put out an extensive report listing the many reasons he believes that timeline is overly optimistic.

RELATED:Sanofi, GSK tie up for COVID-19 vaccine work with eyes on possible 2021 rollout

However, Bos herself is optimisticfor vaccine successshe has worked on influenza, Zika and HIV vaccines and noted that this novel coronavirus has provensimpler than many of those viruses. Because it has not yet changed much, she said, it's easier to design a vaccine than it is for fast-evolving viruses, such as the annual moving target of influenza, for instance.

For Bos, the pandemic offers an opportunity for people to see the real work of pharma scientists and remind them of thebenefit of vaccines. She hopes that by discussing details about COVID-19, peoplewill better understand what scientists at pharma companies doand that their main focus is public health, not making money.

Hopefully we can makeand not just usbut hopefully many companies will be successful and we can produce enough vaccines for the whole world," she said. "The hope is also that the virus will keep being stable and not change over time. In half a year, we will have a lot of data, from us andalso from a lot of companies, that will show if the vaccines can protect people. And thats really the ultimate goal."


See the rest here: What's it like to work on J&J's coronavirus vaccine? For one scientist, it's social distancing in the lab, late nights at home - FiercePharma
Coronavirus vaccine: Here’s what’s brewing in India and globally – Business Today

Coronavirus vaccine: Here’s what’s brewing in India and globally – Business Today

May 13, 2020

The race to find a vaccine and cure for coronavirus has reached its zenith. Many companies and countries have made significant strides in the search for a vaccine for COVID-19. The search for a vaccine seems like a race against time as countries, including India, prepare to open up and relax restrictions that have been in place for at least a month. India is heading towards the end of its third phase of lockdown. The country has over 70,000 cases, with more than 46,000 active cases. More than 2,200 people have died in India, while 22,454 people have been discharged according to the Ministry of Home and Family Welfare.

Here's a lowdown on where India and the rest of the countries stand on their search for corona vaccine:

INDIA

To begin with, Vijay Raghavan, principal scientific adviser to the Government of India told India TV that India is well on course to find a vaccine. He reiterated that finding a vaccine usually takes years and painstaking efforts. However he mentioned in the interview that if all goes well and the process is followed thoroughly, India is very likely to have a corona vaccine the next 8 months in its hands. He added that once it is developed, the COVID-19 vaccine will be distributed to the other parts of the world too. India is collaborating with other nations as well, he added.

Also read: Coronavirus Live Updates: PM Modi may detail graded lockdown exit at 8 pm as India's total cases near 80,000

Meanwhile, Bharat Biotech International Ltd (BBIL) along with the Indian Council for Medical Research (ICMR) are working together to develop a coronavirus vaccine. A vaccine called CoroFlu is already being tested by the biotech firm. BBIL is working with the University of Wisconsin to develop the vaccine. ICMR also stated that it has transferred the virus strain isolated at NIV, Pune to BBIL.

According to reports, a researcher from Maharishi Dayanand University in Rohtak has stated that she has designed a vaccine, the '3CL Hydrolase-based Multi-Epitope Peptide Vaccine against SARS-CoV-2', at the Centre for Medical Biotechnology at MDU. "This is a protein-based vaccine which will strengthen our body's immunity by raising the generation of antibodies against SARS-CoV-2. Utmost care has been taken to ensure that the epitopes used in the vaccine are non-toxic and non-allergic," researcher Dr Renu Jahkhar told The Tribune. Her research paper will be published by the Journal of Medical Virology.

Additionally, the Serum Institute of India said that it is planning to produce 6 crore of potential corona doses of the vaccine that is under clinical trial in the UK. University of Oxford is conducting trials for its vaccine.

Also read: Coronavirus vaccine: List of 5 COVID-19 treatment frontrunners

GLOBAL

World Health Organisation Director General Tedros Adhanom Ghebreyesus informed a UN Economic and Social Council video briefing that there are currently seven or eight top candidates for coronavirus vaccine. He added that efforts are underway and is supported by $8 billion that was pledged a week ago by leaders from 40 countries. "We have good candidates now. The top ones are around seven, eight. But we have more than a hundred candidates," he said.

Meanwhile, Germany has pledged 750 million euros to help in the search of a COVID vaccine. The primary goal of the new funding, approved by Chancellor Angela Merkel, is to include as many volunteers as they can to test the coronavirus vaccine.

US-based Novavax has received $4 million from Coalition for Epidemic Preparedness Innovations (CEPI) to identify and manufacture coronavirus vaccine. In early April, Novavax had stated that it had identified a vaccine called NVX-CoV2373 that had already shown success in animal models. The subunit vaccine is injected into the body that creates antibodies to protect against COVID-19. Novavax plans to start Phase I of clinical trials in mid-May.

Additionally, Moderna RNA vaccine, Oxford University's vaccine, Pfizer's BNT162 vaccine, University of Pennsylvania and Inovio's vaccine as well as Sinovac's vaccine are in various stages of clinical trials.

Also read: Coronavirus: Glenmark to test Favipiravir on COVID-19 patients, sell drug as 'FabiFlu'


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Coronavirus vaccine: Here's what's brewing in India and globally - Business Today
Why a positive Covid-19 antibody test doesn’t mean much of anything yet – CNN

Why a positive Covid-19 antibody test doesn’t mean much of anything yet – CNN

May 13, 2020

You're hoping it will tell you that you have, right? That your blood is full of beautiful antibodies, the body's soldiers called to fight when a known enemy invades our systems again.

You may dare to hope the discovery of antibodies in your blood means you will be immune to the virus in the future you won't ever get it again or give it to anyone else.

That's the holy grail, of course the ticket to freely visiting your parents, friends and loved ones again, to going back to work in the office again basically, to getting your life back.

Not so fast.

In today's reality, testing positive for antibodies to Covid-19 means nothing of the sort. In fact, it may not mean much at all at least right now.

There are still too many unknowns, both about the accuracy of the antibody tests that are available and about the nature of the virus itself.

"And this is exactly why I keep advising people to behave like you have the virus," Gupta said.

What is an antibody test?

An antibody test can only be administered by gathering blood, either through a finger prick or from a vein. It's designed to detect antibodies, the Y-shaped proteins called immunoglobulins that circulate in our blood to help fight off infections in our bodies.

Produced by white blood cells, the two "arms" of the antibody are designed to recognize and fight bacteria and viruses that have been encountered in the past, thus hopefully stopping these germs from taking hold again.

Even if you've never had any symptoms of Covid-19, the presence of antibodies in your blood would show your body has encountered the virus.

To be clear, antibody tests are not the "swab" tests that are meant to find out if you are currently carrying the virus. Called rt-PCR tests, or molecular diagnostic tests, those typically gather mucus from way up the nose or back of the throat. They take a few days to report results.

In addition, both antigen and rt-PCR tests can only give a "snapshot" of your status at that specific point in time. If you were exposed to Covid-19 the next day, you could easily become sick and not know it.

How accurate is the antibody test?

First, let's look at timing. Antibodies just don't appear overnight. It can take weeks to build up enough of a level in the blood to be picked up by even the most sensitive test. So if you have the test before your body has fully responded, it may give you a false negative.

That's if you develop antibodies at all.

To understand that, consider the entire concept behind vaccines. Vaccinations are supposed to give just enough of a live or dead virus to get the body to mount an immune response but not enough to make you sick from the illness.

But everyone is different. Some people don't react to the vaccine at all, or their immune response is not quick or adequate enough to protect them.

Antibody tests are also plagued by error. Just like the diagnostic tests, "antibody tests haven't been as accurate as they need to be," Gupta said. By their very nature, such tests can easily produce both false negatives and positives.

"With the antibody test, what you're really hoping to avoid is a false positive," Gupta said. "Then, someone might feel that they have the antibodies, thus feel that they are protected, go out into the community, to a hospital, to a nursing home and spread the virus."

The tests also need to be able to differentiate between past infections from SARS-CoV-2 and the other known set of six human coronaviruses, four of which cause the common cold and circulate widely.

Then there's the lack of oversight. The need for testing has created a market free-for-all in which companies are creating tests without any scientific oversight.

"There are plenty of antibody tests floating around that haven't been reviewed or validated by the US Food and Drug Administration. It's been a big problem," Gupta said.

If I have antibodies to Covid-19, will I be immune?

Of course, the big question is: If your blood does show antibodies against Covid-19, are you immune to the virus if exposed in the future? Scientists hope that will be the case since it has historically been true for other viruses such as chicken pox and polio.

But so far, there's no evidence of that with SARS-CoV-2.

"It's unclear if those antibodies can provide protection," the US Centers for Disease Control and Prevention says on its website. "This means that we do not know at this time if antibodies make you immune to the virus."

While studies of blood samples taken from people who have recovered from Covid-19 do show an immune response to the virus, some have "very low levels of neutralizing antibodies in their blood," WHO said.

It's possible that immunity may need to occur on a cellular level as well as via antibodies circulating in the blood, the agency warned.

"The body also makes T-cells that recognize and eliminate other cells infected with the virus. This is called cellular immunity," WHO explained.

Along with antibodies, the "combined adaptive response may clear the virus from the body, and if the response is strong enough, may prevent progression to severe illness or reinfection by the same virus," WHO said.

But consider this: Even if we are lucky enough to have that happen, we still don't know how long that immunity will last.

No 'immunity passport' yet

What's the takeaway from the results of your antibody test? Simply put, it really doesn't matter if you test positive or negative, because until testing improves and we understand more about the virus, you (and everyone else) are still at risk.

"At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an 'immunity passport' or 'risk-free certificate,'" WHO stated.


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Why a positive Covid-19 antibody test doesn't mean much of anything yet - CNN
He Was a Science Star. Then He Promoted a Questionable Cure for Covid-19. – The New York Times

He Was a Science Star. Then He Promoted a Questionable Cure for Covid-19. – The New York Times

May 13, 2020

When diagnosing the ills afflicting modern science, an entertainment that, along with the disparagement of his critics and fellow researchers, he counts among his great delights, the eminent French microbiologist Didier Raoult will lightly stroke his beard, lean back in his seat and, with a thin but unmistakable smile, declare the poor patient to be stricken with pride. Raoult, who has achieved international fame since his proposed treatment for Covid-19 was touted as a miracle cure by President Trump, believes that his colleagues fail to see that their ideas are the products of mere intellectual fashions that they are hypnotized by methodology into believing that they understand what they do not and that they lack the discipline of mind that would permit them to comprehend their error. Hubris, Raoult told me recently, at his institute in Marseille, is the most common thing in the world. It is a particularly dangerous malady in doctors like him, whose opinions are freighted with the responsibility of life and death. Someone who doesnt know is less stupid than someone who wrongly thinks he does, he said. Because it is a terrible thing to be wrong.

Raoult, who founded and directs the research hospital known as the Institut Hospitalo-Universitaire Mditerrane Infection, or IHU, has made a great career assailing orthodoxy, in both word and practice. Theres nothing I like more than blowing up a theory thats been so nicely established, he once said. He has a reputation for bluster but also for a certain creativity. He looks where no one else cares to, with methods no one else is using, and finds things. In just the past 10 years, he has helped identify nearly 500 novel species of human-borne bacteria, about one-fifth of all those named and described. Until recently, he was perhaps best known as the discoverer of the first giant virus, a microbe that, in his opinion, suggests that viruses ought to be considered a fourth and separate domain of living things. The discovery helped win him the Grand Prix Inserm, one of Frances top scientific prizes. It also led him to believe that the tree of life suggested by Darwinian evolution is entirely false, he told me, and that Darwin himself wrote nothing but inanities. He detests consensus and comity; he believes that science, and life, ought to be a fight.

It is in this spirit that, over the objections of his peers, and no doubt because of them, too, he has promoted a combination of hydroxychloroquine, an antimalarial drug, and azithromycin, a common antibiotic, as a remedy for Covid-19. He has taken to declaring, We know how to cure the disease. Trump was not the only one eager to embrace this possibility. By the time I arrived in Marseille, some version of Raoults treatment regimen had been authorized for testing or use in France, Italy, China, India and numerous other countries. One in every five registered drug trials in the world was testing hydroxychloroquine.

In March, Raoult announced that his hospital would test and treat anyone who cared to show up. Crowds gathered at the entrance to the IHU in winding single-file lines, like pilgrims shuffling toward their private audience with the oracle. On March 16, Raoult released the results of a small clinical trial that showed, he said, a 100 percent cure rate. The study has since been widely debated, and Raoults boosterism has been lamented by scientists and health officials around the world; in a comment more or less representative of the tenor of the controversy in France, where Raoults name and image have now been everywhere for weeks, one detractor, a generally thoughtful politician, suggested that Raoult shut his face and be a doctor and that he stop saying Im a genius all over the place.

His colleagues liken his psychology to that of Napoleon, though he is not physically small. When asked by one journalist about his tendency to swim against the current of scientific thought, Raoult responded: Im not an outsider. Im the one whos farthest out in front. Axel Kahn, a geneticist and physician who has known Raoult for nearly 40 years, told me that he has always been this way. One of Professor Raoults abiding characteristics is that he knows that hes very good, Kahn told me. But he considers everyone else to be worthless. And he always has. Its not a recent development. At his home, alongside a collection of Roman busts, he is said to keep a marble statue of himself.

Raoult, who is 68, is a sturdily built but fine-featured man, with high cheekbones and a tight, contemptuous mouth. In recent years, he has hidden these behind a straggly white mustache and goatee and has grown his flaxen hair down to his shoulders. On his right pinkie he now wears a silver skull. In internet memes, he has been depicted as the wizard Gandalf and as a druid; except for his white lab coat, he has the general aspect of a fortuneteller who rides a Harley to work. The French journalist Herv Vaudoit, who has written admiringly about Raoult over the years, once asked him why hed taken to dressing this way. Raoult replied, Because it pisses them off.

In the weeks since SARS-CoV-2, the virus that causes Covid-19, spread throughout the world, his disdain for respectable opinion, and for the Parisian marquesses who are its representatives, has endeared him to a large segment of the French population. According to one survey, by late March, Raoult had become one of Frances most popular political personalities, with particular appeal on the populist extremes. Votives bearing his image were being sold in Marseille, and on some evenings, at 8 p.m., a battalion of municipal garbage trucks assembled on the roadway outside his hospital, where the drivers leaned on their horns in loud and furious tribute. A hundred-foot banner, painted by a club of local soccer fans and strung up near the entrance, read, Marseille and the world behind Prof. Raoult!!!

Raoult has been collecting the merchandise created by his fans, and he seems to be enjoying his fame, though he claims otherwise. He is certain the drugs will vindicate him in the end; everything else is a matter of appearances. I really do think were in a theater, he told me. In my play, the people who judge me as a doctor are my patients. As a scientist, its my colleagues. And time.

A few weeks ago, I spoke, from the recommended distance, to a man named Jacques Cohen. He was seated on the sidewalk outside the IHU, an angular monument of concrete and glass about a mile and a half from Marseilles old port. Cohen had his back against a pylon and his wrists on his knees, at the edge of a group of perhaps 60 people. By their unworried proximity to one another they were standing around in a loose group, as people used to, waiting to enter the hospital through a side door they were identifiable as the unfortunates who already knew they were positive. I had selected Cohen as my interlocutor under the guidance of a nearby nurse. He was not coughing or sneezing; he wore a mask. In any case, were all going to get it, the nurse said.

I crouched on the pavement and asked Cohen, who is 76, how he was feeling. For the past two days, he had been taking hydroxychloroquine and azithromycin. Its getting better, Cohen said through his mask. He looked ashen but optimistic. His fever had fallen, and he had begun to regain his sense of taste. I noted that there was some debate about the efficacy of the treatment. Theres no believing or not believing, Cohen replied. We know its effective!

Hydroxychloroquine and azithromycin are well characterized, well tolerated and widely prescribed medications. Azithromycin was developed 40 years ago in the former Yugoslavia and is today the second-most commonly prescribed antibiotic in the United States. Hydroxychloroquine, along with its more toxic analog chloroquine, was for several decades the most commonly prescribed antimalarial drug in the world. Today it is widely used to treat rheumatoid arthritis and lupus. All three molecules are included on the World Health Organizations Model List of Essential Medicines, a compilation of the most efficacious, safe and cost-effective medicines for priority conditions.

Raoult knows the drugs well. From the start of his career, he has experimented extensively with drug repositioning, in which medicines that have been approved for use against one disease are repurposed as treatments for others. Hundreds and hundreds of molecules have already been approved for human use by the Food and Drug Administration. Hidden among these, Raoult contends, are various unanticipated cures. You test everything, Raoult told me. You stop pondering; you just look and see if, by chance, something works. And what you find by chance, itll knock you on your derrire. Antidepressants and antihypertensives have been shown to have antiviral properties; lovastatin, which is prescribed to lower cholesterol levels, has been found to be effective, at least in mice, against plague. In a 2018 paper, Raoult and a team of researchers reported that azithromycin showed strong activity in cells infected with the Zika virus.

Raoult spent the first decade of his life in Dakar, in what was then French Senegal, where his father, a military doctor, was posted. To ward off malaria, he was given chloroquine. I took it all the time when I was a kid, he told me. In the 1990s, in an early repurposing experiment, he tested the effect of hydroxychloroquine on a frequently fatal condition known as Q fever, which is caused by an intracellular bacterium. Like viruses, intracellular bacteria multiply within the cells of their hosts; Raoult found that hydroxychloroquine, by reducing acidity within the host cells, slowed bacterial growth. He began treating Q fever with a combination of hydroxychloroquine and doxycycline and later used the same drugs for Whipples disease, another fatal condition caused by an intracellular bacterium. The combination is now considered to be a standard treatment for both diseases.

Given the similarities between intracellular bacteria and viruses, Raoult suspected that chloroquine and hydroxychloroquine might have antiviral effects. Following the SARS outbreak in 2002, researchers found that chloroquine slowed reproduction of the SARS coronavirus in cell cultures. Raoult reviewed that evidence in a 2007 paper, concluding that chloroquine and hydroxychloroquine might be an interesting weapon to face present and future infectious diseases worldwide. This winter, as the spread of SARS-CoV-2 began to take on the contours of a pandemic, he surveyed the data that had begun coming out of China. An early report on chloroquine showed good results in vitro. In mid-February, another Chinese team reported that, in more than 100 patients, it had been found to have potent activity against Covid-19. Raoult was elated.

At the time, health authorities around the world were warning that a viable treatment could be months away. The Chinese reports, however, appeared to confirm Raoults longstanding hopes for chloroquine. A deadly virus for which no treatment existed could evidently be stopped by an inexpensive, widely studied, pre-existing molecule, and one that Raoult knew well. A more heedful scientist might have surveyed the Chinese data and begun preparations for tests of his own. Raoult did this, but he also posted a brief, jubilant video on YouTube, under the title Coronavirus: Game Over! Chloroquine had produced what he called spectacular improvements in the Chinese patients. Its excellent news this is probably the easiest respiratory infection to treat of all, Raoult said. The only thing Ill tell you is, be careful: Soon the pharmacies wont have any chloroquine left!

Raoult has spent nearly his entire life in Marseille, a famously ragged and combative city, which he loves. He named a genus of bacteria, Massilia, for it and has given its name or the names of its neighborhoods to numerous other species of microbe. Marseille has been a major port for more than 2,000 years and has a correspondingly rich history of disease. It was the point of entry into France for all three of the great waves of bubonic plague, beginning in the sixth century. Between 1720 and 1722, the plague killed about half of Marseilles population; one of its central neighborhoods, on the old port, is today named for the bishop who tended to the ill while the citys doctors hid in fear.

Raoult wrote his first research paper, in 1979, on a tick-borne infection sometimes known as Marseille fever. The disease was also called benign summer fever, and more than 50 years of science said it was nonlethal. And yet one of the 41 patients in his data set had died. Before submitting the paper, Raoult, who was then a young resident, gave it to a supervising professor for review. And he takes it, Raoult told me, he doesnt show it to me again, and he publishes it and hed taken out the death. Because he didnt know how to make sense of the death. Raoult was disgusted, and the incident shaped his philosophy of scientific inquiry. I learned that the people who wanted to follow the familiar path were prepared to cheat in order to do it, he said. In subsequent work, he demonstrated that Marseille fever was indeed fatal in almost precisely one in every 41 cases. He was a follower, Raoult said of the professor. And these followers are all cheaters. Thats what I thought. And its still what I think.

He is, fundamentally, a contrarian. In Raoults view, little of consequence has been accomplished by researchers who endorse the habitual tools and theories of their age. Ive spent my life being against, he told me. I tell young scientists: You know, you dont need a brain to agree. All you need is a spinal cord. He is thrilled by conflict. It is a matter both of philosophy the influence, no doubt, of the thinker he refers to admiringly as master Nietzsche and of temperament. He loves to know that things are roiling around him, one of his lab technicians told me; he sets off storms and admires them as they roll out over the land. His peers shake their heads at this behavior but grant him a grudging respect. You cant knock him down, said Mark Pallen, a professor of microbial genomics at the University of East Anglia. In terms of his place in the canon, the sainthood of science, hes pretty secure there.

He is also interested in power and has been attentive to it from the start. In 1985 and 1986, Raoult worked at the Naval Medical Research Institute in Bethesda, Md., where he discovered the Science Citation Index. The index, a tool that can be used to measure a scientists influence on the basis of his or her publication history, was relatively unknown in France. Raoult looked up the researchers reputed to be the best in Marseille. It was really the emperor wears no clothes, he said. These people didnt publish. There was one who hadnt written a paper in 10 years. In Raoults view, French science was a duchy of appearances, connections and self-reverence. It was people saying he mimed the drone of an aristocrat Oh, him, yes, hes very good. And this reputation, you dont know what its based on, but its not the truth.

For decades, Raoult has boasted of his prodigious rates of publication and citation, which, as objective statistics, he considers to be the best measure of his worth as a researcher. Biomedical researchers in France write or contribute to perhaps 10 scientific papers every year and a few hundred in the course of a career. Raoults name sits atop several thousand; in each of the past eight years, he has produced more than 100. In 2020, he has already published at least 54.

Raoult is reputed to be an indefatigable worker, but he also achieves his extreme rate of publication by attaching his name to nearly every paper that comes out of his institute. Though the practice is not unheard-of, it is unusual. Even to just read those papers would take up a large percentage of anyones time, Pallen told me. For someone like me to actually go through them carefully, critique them, make a substantial intellectual contribution I think that would be practically impossible.

With few exceptions, the department heads at the IHU have worked under Raoult for their entire careers, some for more than 30 years. It is an ancestral system, familial and clanlike, said Michel Drancourt, a clinician who is Raoults longest-serving collaborator. Raoult is, without question, the patriarch, and he is in some respects reputed to be benevolent. The IHU spends a great deal of money on scholarships and research grants for students from the developing world, for instance, and Raoult is known to be accessible to young researchers in a way that distinguishes him from other high-powered scientists. He is also known for berating his subordinates. While visiting the IHU, I watched a young researcher emerge from Raoults office in tears and rush into the arms of her friends, who were evidently accustomed to this. When hes not happy about something, hell let you know, one of them told me. A 2017 employee letter of complaint, which was followed by an investigation of the IHU, described the screaming, insults and psychological bullying of a leadership of another era. Along the entryway to Raoults institute, theres a line from Horace: Exegi monumentum aere perennius, I have crafted a monument more lasting than bronze.

In recent years, Raoult has amused himself, it seems, by staking out tendentious scientific claims, sometimes in territories that are well beyond the scope of his expertise. He is skeptical, for instance, of the utility of mathematical modeling in the realm of epidemiology. The same logic has led him to conclude that climate modelers are no more than soothsayers for our scientistic era and that their dire predictions are mostly just an attempt to expiate our intense but irrational feelings of guilt.

He is also dismissive of the alarmism that is the default position among specialists of infectious disease. He doubted, initially, that SARS-CoV-2 would spread beyond China, or that it might be a terrible problem if it did. On Jan. 20, Chinese scientists confirmed that infections were being transmitted from patient to patient, and President Xi Jinping, in his first public comments about the coronavirus, declared that all possible measures would have to be taken to contain the outbreak. The World Health Organization announced an emergency meeting. The following day, in Marseille, Raoult posted a video to his institutes YouTube channel. He faced his offscreen interviewer with weary eyes, sighed and said, You know, the world has gone crazy. Every year, he said, there are probably 600 or 700 people who die from coronavirus infections in France and thousands more from other respiratory illnesses. The fact that people have died from a coronavirus in China, I dont feel like it means much of anything for me, he said. I dont know, maybe people dont have anything to do, so theyve gone looking in China for something to be scared about.

Raoults most recent book, Epidemics: Real Dangers and False Alerts, was published in late March, by which time the W.H.O. had reported more than 330,000 confirmed cases of Covid-19 worldwide and more than 14,500 deaths. This anguish over epidemics, he writes, is completely untethered from the reality of deaths from infectious diseases.

By the standards of molecular biology, real-time polymerase chain reaction, the technology most commonly used to test for SARS-CoV-2, is not extravagantly complex. But it depends upon collection swabs, thermocycling machines, chemical reagents and nucleotide probes and primers, and if any one of these components is in insufficient supply, the tests cannot be run. Beginning in January, when the SARS-CoV-2 genome was first published, the IHU bought or borrowed as much of all these as possible, spending a half million euros on new machines alone. Whatever Raoults reservations about the virus, he did not intend to miss the opportunity to study it, and perhaps to win the race to find a treatment. His institute receives most of its funding from public sources Raoult was given 130 million euros to build it but it effectively controls its own budget, and Raoult, as the founding director, has near-complete control of what goes on inside its walls. He can essentially say, Hold on, I want to turn the bedroom and the dining room into a kitchen, Drancourt said.

Nearly 800 people work at the institute. In early March, as coronavirus patients began arriving, almost all the staff members turned their efforts to SARS-CoV-2. Raoult obtained authorization to begin a small clinical trial of hydroxychloroquine. Because viral respiratory infections often lead to secondary bacterial infections, however, Raoult wanted to test a supplementary antibiotic in some patients; he chose azithromycin, which he had previously tested against Zika. If youre going to choose one, you might as well choose one thats been shown to be active against a virus, said Bernard La Scola, who runs the biosafety lab at the IHU.

Hydroxychloroquine is believed to inhibit viral reproduction in infected cells by raising their pH, as in Q fever and Whipples disease; the antiviral mechanism of azithromycin has not been explained. But what works works. If we relied only upon medications with precisely established mechanisms, a number of popular drugs acetaminophen, for instance, the active ingredient in Tylenol would not be in use. I asked Raoult if the idea to test the drugs together had emerged from discussions with his team. It was me, he told me. Dont kid yourself.

Testing had been scheduled to run for two weeks per patient, but after only six days, the results were so favorable that Raoult decided to end the trial and publish. Usually, wed take time to write, to make corrections, to consider, to go over things 50 times, said Philippe Gautret, the department head who was the first listed author on the paper. In this case, we were working with a sense of real urgency. Because we thought we had to get the word out, because, maybe, wed found a way to make things better.

Others might have proceeded with more caution or perhaps waited to confirm these results with a larger, more rigorous trial. Raoult likes to think of himself as a doctor first, however, with a moral obligation to treat his patients that supersedes any desire to produce reliable data. Were not going to tell someone, Listen, todays not your lucky day, youre getting the placebo, youre going to be dying, he told me. He believes it to be unnecessary, in addition to being unethical, to run randomized controlled trials, or R.C.T.s, of treatments for deadly infectious diseases. If these have become the accepted standard in biomedical research, Raoult contends, it is only because they appeal to statisticians who have never seen a patient. He refers to these scientists disdainfully as methodologists.

Raoults paper included results for 36 patients. Fourteen were treated with hydroxychloroquine sulfate; six were treated with a combination of hydroxychloroquine sulfate and azithromycin; and 16 served as controls. On Day 6 of the trial, 14 of the 16 control patients still tested positive for the virus. Patients receiving hydroxychloroquine fared markedly better, with only six of 14 testing positive on Day 6. Most encouraging, though, all six patients treated with a combination of hydroxychloroquine and azithromycin were found to be rid of the virus.

Several prominent French doctors cautioned that the results would have to be confirmed and warned of possible side effects. The French health minister deemed the trial promising but called for more testing. Raoult had already begun assembling data for a larger study, but he dismissed the need for anything particularly vast or lengthy. Like other critics of the R.C.T., he likes to point out that a number of self-evidently useful developments in the realm of human health have never been validated by such rigorous tests. This observation has come to be known as the parachute paradigm: We tend to accept the claim that parachutes reduce injury among people who leap from airplanes, but this effect has never been proved in a randomized study that compares an experimental parachute group to an unlucky parachuteless control. Its like Didier says, Drancourt told me. If you dont have something thats visible in 10 patients, or 30, its useless. Its not of any consequence. An effective treatment for a potentially lethal infectious disease will be visible to the naked eye.

On March 16, a Long Island attorney and blockchain enthusiast named Gregory Rigano appeared on Laura Ingrahams nightly show on Fox News, The Ingraham Angle. Ingraham introduced the segment by asking: What if theres already a cheap and widely available medication, thats on the market, to treat the virus? Well, according to a new study, there is such a drug. Its called chloroquine. Rigano, who at the time was falsely presenting himself as an adviser to Stanford Medical School, had recently self-published an acclamatory report on the potential of chloroquine, An Effective Treatment for Coronavirus (Covid-19), as a Google Doc formatted to resemble a scientific publication. It had begun to circulate in right-wing media and also in Silicon Valley; Elon Musk tweeted a link to it. Raoult saw it and noticed the attention it was receiving online. Another researcher might have found this sort of publication irresponsible and dangerous. Raoult began corresponding with Rigano and his co-author, James Todaro, an ophthalmologist and Bitcoin investor. Raoult authorized them to share his results before they had been published.

On air, Rigano announced that a researcher in the south of France, one of the most eminent infectious-disease specialists in the whole world, was about to publish the results of a major clinical study. Within a matter of six days, the patients taking hydroxychloroquine tested negative for coronavirus, for Covid-19, Rigano said. (He made no mention of azithromycin.) We have a strong reason to believe that a preventative dose of hydroxychloroquine is going to prevent the virus from attaching to the body, and just get rid of it completely, he added. Thats a game changer, Ingraham said.

In the coming days, Ingraham questioned both Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and a member of President Trumps pandemic task force, and Alex M. Azar II, the secretary of health and human services, about the drug. Sean Hannity began promoting it as a cure for Covid-19. Lets put it this way, he said on his radio show. If I had it personally, I am speaking only for Sean Hannity I would be all over this. Rigano appeared on Tucker Carlsons show and claimed that Raoults study had shown hydroxychloroquine to have a 100 percent cure rate against coronavirus. According to Todaro, Raoult had sent him a copy of his study and allowed him to post it on Twitter that day, two days before the preprint release. I suspect he gave us permission because he knew it was the fastest way to disseminate the trial results, Todaro told me. (Rigano did not respond to requests for comment.) Later, Raoult himself appeared on Dr. Oz, the talk show hosted by the celebrity doctor Mehmet Oz, a frequent Fox News guest who has promoted hydroxychloroquine. I believe that ideas and theories are epidemic, Raoult once wrote. When theyre good, they take root.

Trump began hyping hydroxychloroquine on March 19, at a White House news conference with his coronavirus task force. I think its going to be very exciting, Trump said. I think it could be a game changer and maybe not. And maybe not. But I think it could be, based on what I see, it could be a game changer. Very powerful. He suggested, inaccurately, that the F.D.A. had approved the drug for use against Covid-19. He made no mention of azithromycin. Commissioner Stephen M. Hahn of the F.D.A. gently corrected him later and said that a large clinical trial would be the appropriate way to evaluate the therapeutic value of the drug.

Still, because chloroquine and hydroxychloroquine are available for use in other conditions, doctors were able to provide Covid-19 patients with off-label treatment if they believed it would provide a benefit. Shortages of the drugs were reported beginning in mid-March. The F.D.A., under what appears to have been strong pressure from the Trump administration, issued an emergency-use authorization for chloroquine phosphate and hydroxychloroquine sulfate, giving doctors access to tens of millions of doses of the drugs from the Strategic National Stockpile. Unusually, the C.D.C., at what was reportedly Trumps direct urging, issued Covid-19 prescription guidelines for the drugs based upon unattributed clinical anecdotes. (The guidelines were later withdrawn.) A top government biomedical official was removed from his post, he has claimed, for having resisted political pressure to fund potentially dangerous drugs, including hydroxychloroquine.

There is much about Raoult that might make him, and by extension his proposed treatment, appealing to a man like Trump. He is an iconoclast with funny hair; he thinks almost everyone else is stupid, especially those who are typically regarded as smart; he is beloved by the angry and conspiracy-minded; his self-congratulation is more or less unceasing. Raoult and I spoke several days after the emergency-use authorization was signed. He said he hadnt heard about it and seemed surprised, but he also said that Trump had impressed him with his intuition on hydroxychloroquine. Hes not so dumb, he said, laughing. Raoult classified Trumps psychology as that of an entrepreneur, by way of contrast with that of a politician. Entrepreneurs are people who know how to decide, who know how to take risks, he said. And at a certain point, to decide is to take a risk. Every decision is a risk.

The French waited far too long, in his estimation, to approve the use of hydroxychloroquine in Covid-19 patients. The authorization came only after Raoult announced in the press that he would continue, in accordance with the Hippocratic oath and effectively in defiance of the government, to treat patients with his combination therapy. Im convinced that in the end, everyone will be using this treatment, Raoult told Le Parisien. Its just a matter of time before people agree to eat their hats.

The dynamics of a crisis are not especially conducive to reliable science. In October 1985, in the terrible early years of the AIDS epidemic, a group of French doctors, joined by the French minister of social affairs, held a news conference to announce to the world that they had discovered what looked like a cure. The drug was cyclosporine, an inexpensive immunosuppressant that had until then been used in organ transplants to prevent the rejection of new tissue. In AIDS patients, cyclosporine had the paradoxical effect of increasing white-blood-cell counts; patients underwent a spectacular improvement, one researcher said. The announcement was based upon results from only two patients, however, and these patients had begun treatment only one week earlier. The scientists were widely criticized at the time for flouting the norms of biomedical research to report such limited data. Given the strength of our hypotheses, they responded, we believe that, ethically, we could not continue to keep our results a secret just to respect the usual laws of scientific conduct.

Like Raoult, they felt very strongly about what they said, said Jean-Michel Molina, who directs the infectious-disease departments at two public hospitals in Paris. They felt that they had found a cure. Shortly after the announcement, one of the two patients died, and it was revealed that a third patient had died before the news conference; he had been excluded from the reported results because his case was considered too grave to reverse. Within weeks, the remaining patients white-blood-cell count had fallen to its previous level. Experimentation with cyclosporine soon stopped.

Like many doctors, Molina viewed Raoults study with skepticism, but he was also curious to see if his proposed treatment regimen might in fact work. He tested hydroxychloroquine and azithromycin in 11 of his own patients. We had severe patients, and we wanted to try something, Molina told me. Within five days, one had died, and two others had been transferred out of his service to intensive care. In another patient, the treatment was suspended after the onset of cardiac issues, a known side effect of the drugs. Eight of the 10 surviving patients still tested positive for SARS-CoV-2 at the conclusion of the study period. Raoults data had come from patients with mild or early cases of the disease, when viral loads are lower, and I asked Molina if his patients had not been too sick to benefit from the treatment. If there is antiviral activity, you should be able to see it, he said. You know, you may say, Its too late, youre not going to see the clinical benefit. But at least you should see the antiviral activity. If its an antiviral.

Raoults study had measured only viral load. It offered no data on clinical outcomes, and it was not clear if the patients actual symptoms had improved or indeed whether the patients lived or died. At the outset, 26 patients were assigned to receive hydroxychloroquine, six more than the 20 who appeared in the final results. The six additional patients had been lost in follow-up, the authors wrote, because of early cessation of treatment. The reasons given were concerning. One patient stopped taking the drug after developing nausea. Three patients had to be transferred out of the institute to intensive care. One patient died. (Another patient elected to leave the hospital before the end of the treatment cycle.) So four of the 26 treated patients were actually not recovering at all, noted Elisabeth Bik, a scientific consultant who wrote a widely circulated blog post on Raoults study. She paraphrased the sarcasm circulating on Twitter: My results always look amazing if I leave out the patients who died.

The report was also riddled with discrepancies and apparent errors. Its selection criteria called for participants above the age of 12, but three of the control subjects were younger than this. The control patients were drawn not only from the IHU but also from hospitals in two other cities, where the standard of care and the testing protocols may have differed. Fourteen of 16 control patients were reported to have tested positive for the virus at the conclusion of the study on Day 6. In fact, according to the initial report, for five of those 14, no data was collected that day. One of the six patients who received hydroxychloroquine and azithromycin and was recorded as virologically cured at Day 6 was found, in the end, to be carrying the virus two days later.

This apparent sloppiness was unsurprising to many of those who have tracked Raoults work in the past. A prominent French microbiologist told me that, in terms of publication, Raoults reputation among scientists has been long gone for some time. In private, the researcher wrote to me, everybody agrees on the low reliability/reproducibility of most of the papers coming out of his lab. (He asked to speak anonymously so as not to anger Raoult, whom he knows.) In 2018, after damning evaluations, Raoults principal laboratory groups were stripped of their association with two of Frances top public research institutions. Raoult was found to have produced an extraordinary number of publications but few of great quality. Its very easy to publish [expletive] when you know how publishing works, said Karine Lacombe, a professor of medicine in Paris who has recently been among Raoults more outspoken critics.

Beyond its apparent errors and omissions, the studys design its small size, its flawed control, the unrandomized assignment of patients to the treatment and control groups was widely viewed to render its results meaningless. Fauci repeatedly called its results anecdotal; the biostatistician who analyzed the paper on behalf of the French governments coronavirus advisory committee wrote that it was impossible to interpret the effect described therein as being attributable to treatment with hydroxychloroquine.

Large, well-controlled randomized trials are by no means the only way to arrive at useful scientific insights. Their utility is that they enhance statistical signals such that, amid the noise of human variability and random chance, even the faint effect of some new treatment can be detected. The prime statistical hurdle that any proposed treatment for Covid-19 will have to overcome one that is delicate for even Raoults critics to make note of, amid the sorrow and fear of this pandemic is that the signal is likely to be very faint, because the disease is, in the end, rarely fatal. Nearly everyone survives; an effective treatment will save the life of the one or so patients in every hundred who would not have lived without it. You know, people sometimes say, If the patient gets better, thats because of the drug, and if they get worse, its because of the virus, Molina told me. And of course thats not true. And thats why you need to do a well-conducted, randomized, placebo-controlled study if you want to show anything. It is possible that hydroxychloroquine and azithromycin are an effective treatment for Covid-19. But Raoults study showed, at best, that 20 people who would almost certainly have survived without any treatment at all also survived for six days while taking the drugs Raoult prescribed.

If you havent done this stuff, you can look at a report of people responding to such a treatment and gure that the answer is here right here, and anyone who doesnt see it must have some ulterior motives, Derek Lowe, a longtime pharmaceutical researcher, wrote for Science Translational Medicine last month. But thats not how it works. He went on: Alzheimers drugs, obesity drugs, cardiovascular drugs, osteoporosis drugs: Over and over, there have been what looked like positive results that evaporated on closer inspection. After youve experienced this a few times, you take the lesson to heart that the only way to be sure about these things is to run sufciently powered controlled trials. No shortcuts, no gut feelings just data.

Ive invented 10 or so treatments in my life, Raoult told me. Half of them are prescribed all over the world. Ive never done a double-blind study in my life, never. Never! Never done anything randomized, either. He noted, with some satisfaction, that the criticism was more intense than he had anticipated. Honestly, I couldnt have imagined that it would set off a frenzy like this, he said, leaning back in his office chair and gesturing at the storm he had created in the world outside. When you tell the story, its extremely straightforward, no? Its subject, verb, complement: You detect a disease; theres a drug thats cheap, whose safety we know all about because theres two billion people who take it; we prescribe it, and it changes what it changes. It might not be a miracle product, but its better than doing nothing, no?

His subordinates defended the study as the best work they could do under the circumstances and the fastest way to alert the world to the possibility of a treatment. The use of off-site controls was not ideal, for example, but it was the only option if they wanted to move fast. Of course its a methodological weakness, Gautret, the first author, told me. But we made do with what we had. As for the six patients lost in follow-up, even if it had been possible to collect data from them, it would have been nonsensical to include most of them in their report. Their aim was to treat people in the early stages of the disease, when its not yet serious, Gautret said. We know that in acute viral diseases, the earlier you treat, the better your chances of success. It makes no sense to include people who are at the edge of death in the study. Were not claiming to be able to treat people who are nearly dead. Another small study, in 80 patients, likewise showed better results for patients with mild forms of the disease.

In Marseille, Raoult told me he would be releasing a third study, this one of 1,000 patients, the following week. Initial results were published in mid-April. Raoult had treated 1,061 patients with a combination of hydroxychloroquine and azithromycin. The study was neither controlled nor randomized; at the time of the preprint release, eight patients had died, and five remained hospitalized, while 46 in total experienced a poor clinical outcome. The findings were summarized as 98.7 percent of patients cured so far. The therapy constituted a safe and efficient treatment for Covid-19, the authors wrote.

Other scientists disagreed with this characterization of the results. The cure rate is almost identical to whats been described about the natural course of the disease, the virologist Christine Rouzioux told French radio. Lacombe called Raoults conclusions magical thinking, adding: I very honestly think he hasnt shown anything at all. It was soon discovered, too, that the second and third studies had been conducted without approval from a state ethics board. In an initial version of the third paper, Raoult wrote that he had conducted a retrospective study on a cohort of patients receiving standard treatment following a research protocol previously registered. He provided a reference to the protocol that had been approved for the first trial. But that protocol included hydroxychloroquine alone and not azithromycin; Raoult never received approval to systematically test a combination of the drugs.

The French medical regulatory agency, the A.N.S.M., sent Raoult a request for evidence of the second studys legal status in mid-April. Later in the month, the French Medical Council issued a statement, widely assumed to be directed at Raoult, reminding its members that the endangerment of patients by exposure to treatments that have not been scientifically validated could be cause for immediate suspension. Raoult responded on Twitter, where he now has a half million followers, that the councils threat was obviously not applicable to his case. In a statement on the A.N.S.M.s inquiry, the IHU insisted that the study did not involve experimentation because no procedure beyond the standard of care which, at the IHU, was hydroxychloroquine and azithromycin had been employed.

Raoult had by then begun to lose his composure. He accused Lacombe of being a shill for the pharmaceutical industry; his fans sent her death threats. On Twitter, he called Bik, the consultant who wrote critically about the first study, a witch hunter and called a study that she tweeted one of several published in April and May that seemed to suggest that Raoults treatment regimen was ineffectual or even harmful fake news. The authors of another such study were accused of scientific fraud. My detractors are children! Raoult told an interviewer. The worlds attention has drifted to new studies of other drugs; Raoult has taken to attacking those studies for their methodological weaknesses.

The results of his initial trial have yet to be replicated. I think what he secretly hopes is that no one will ever be able to show anything, Molina told me. That all the trials conducted on hydroxychloroquine will not be able to even reach a conclusion of no efficacy. In recent weeks, Raoult has in fact tempered his claims about the virtues of his treatment regimen. The published, peer-reviewed version of the final study noted that another two patients had died, bringing the total to 10. Where the earlier version called the drugs safe and efficient, they were now described merely as safe.

He has shown flickers of what appears to be doubt. In one interview, Raoult quoted Camus, from the fatalistic coda of The Stranger, hoping that on the day of my execution there should be a huge crowd of spectators, and that they should greet me with howls of hatred.

I dont trust popularity, he told the interviewer. When too many people think youre wonderful, you should start to wonder. His initial YouTube video, Coronavirus: Game Over! has also been renamed. The new language is more measured, and in place of the exclamation point there now stands a question mark.


See original here: He Was a Science Star. Then He Promoted a Questionable Cure for Covid-19. - The New York Times