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Antibody Treatments, Though Promising, Will Be in Short Supply



Nearly two weeks ago, President Trump told Americans that they would soon be getting an antibody treatment that he had promoted, without evidence, as a “cure” for the coronavirus. This weekend, as the country braced for another major wave of coronavirus infections, Mr. Trump’s health secretary promised such therapies were just around the corner.

But these statements are misleading, at best. Even if the drugs are proven to work — still a big if — there’s little chance that they will soon be widely available. A smooth distribution of the antibody treatments will be dependent on the very same factors that have so far bedeviled the country’s response to Covid-19: fast and plentiful testing, coordination between state and federal officials, and equitable access to health care.

Supply will be extremely limited at first, even though the pool of patients who might benefit is vast, raising messy questions about who should be first in line for treatment. The drugs are believed to work best in people who have recently been infected and are not yet very sick.

“It is just a setup for everything challenging about the pandemic that we’ve had until now, which is confusion, inequity, delays, reliance on testing,” said Dr. Walid Gellad, the director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. The therapies are promising, he said, but with “everything that’s gone wrong, it’s going to accentuate the problems.”

Roughly 60,000 Americans are testing positive for the coronavirus every day, yet the company that provided the president’s antibody treatment, Regeneron, has said it will have only 50,000 doses initially. Eli Lilly, which is developing a similar product, has said it will have 100,000 doses at first. Regeneron will eventually have 300,000 doses, and Eli Lilly will have up to one million before the end of the year. Both companies have applied to the Food and Drug Administration for emergency authorization of their products.

Administering the treatment is not as simple as handing out a bottle of pills. The therapies are given intravenously, requiring an infected person to visit a medical clinic or a hospital.

That’s assuming that the distribution will go smoothly. Officials with Operation Warp Speed, the government effort to speed treatments and vaccines to market, recently told reporters that the federal government would hand over to states the job of allocating the initial doses of Regeneron drugs. But those state agencies are overwhelmed from handling the current influx of new cases, as well as from planning for the distribution of coronavirus tests and future vaccines, and have not yet made detailed plans for deciding how to allocate the antibody treatments to hospitals and clinics.

ImageCoronavirus testing at the Regeneron and Eli Lilly antibody trial site in Mesa, Ariz. A smooth rollout of approved antibody treatments would require fast and frequent testing, among other hurdles currently bedeviling the country’s response to the virus.
Credit…Adriana Zehbrauskas for The New York Times

“We really have a lot going on, and this has not been front and center,” said Dr. Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Officials.

Even some company executives have acknowledged that the country may not yet be up to the challenge. Dr. George Yancopoulos, the president and chief scientific officer of Regeneron, said in a recent call with investors and reporters that communities would need to have rapid testing and contact tracing in place to identify the best candidates for the treatments.

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“We, as a society, are literally trying to fly a plane while we’re trying to build it here,” he said.

Early data about the therapies have shown that they help clear the virus in people who have recently been infected, and that they may help prevent hospitalizations. In another positive sign, the F.D.A. recently approved an Ebola treatment made by Regeneron that uses the same technology.

Eli Lilly and Regeneron have said the antibodies might be used both as a treatment for those who are sick and to prevent infection in people who have been exposed. The treatments could serve as a bridge to a vaccine, protecting high-risk groups like nursing home residents and the workers who care for them.

Still, it’s unclear when the F.D.A. will give a green light to emergency authorization. Regulators must review a mountain of data and decide which groups might benefit the most. Last week, a government-backed clinical trial testing the Eli Lilly therapy in hospitalized patients was paused for unspecified safety reasons, and it will not restart until at least Oct. 26.

If an emergency authorization does come through, Regeneron’s first 300,000 doses will go to the federal government, thanks to an advance purchase agreement. Those initial doses will be free of charge to Americans.

Eli Lilly has not made a similar deal, but at a recent news conference, the chief executive, David A. Ricks, said “conversations are ongoing” with Operation Warp Speed.

There are also likely to be questions about whether wealthy or well-connected patients will be able to unfairly move to the front of the line. Few would argue that the president should not have been given emergency access to Regeneron’s treatment, given the national security stakes. But it’s unclear what criteria Eli Lilly used when the drugmaker cleared its treatment for Chris Christie, the former governor of New Jersey. (A spokeswoman for Eli Lilly declined to discuss specific cases, citing patient privacy, but she said the company approves such treatments on a case-by-case basis in “exceptional circumstances.”)

Credit…Lauren Justice for The New York Times

Dr. Douglas B. White, a medical ethicist and professor of critical care medicine at the University of Pittsburgh School of Medicine, said he hoped hospitals would apply the lessons they had learned when another experimental Covid-19 drug, remdesivir, was initially scarce. Then, too, the federal government asked states to take responsibility for how the drug was allocated.

Dr. White wrote guidelines that were adopted by Pennsylvania that recommended giving priority to people from economically disadvantaged communities, who are at higher risk of dying from Covid-19. The same rules should apply to the antibody treatments, if they are in short supply, he said.

“There needs to be clear guidelines, and there needs to be efforts to mitigate the inequitable outcomes across groups in society,” he said.

Dr. Plescia, of the state health officials group, said he believed that most states had worked out the kinks that occurred with remdesivir. Now, he said, “I think there’s a distribution chain in place that could be adapted to this.”

The antibody treatment will present new challenges.

Eli Lilly has said that people who are older and obese are at higher risk for poor outcomes from Covid-19 and will benefit the most from the treatment. Regeneron has said that people whose bodies are not producing antibodies appear to be the best candidates.

In early trial data released by Eli Lilly, 5.8 percent of people who received a placebo were hospitalized or visited an emergency room for Covid-19, compared with 0.9 percent of people in the group that received the antibody treatment. Figuring out who will benefit the most is an enormous challenge, because most people will recover on their own.

Geoffrey Porges, a pharmaceutical analyst with SVB Leerink, an investment bank, said that means that 100 patients would need to be treated to prevent about five from going to the hospital. “That’s expensive and complicated, and you don’t know who the five are that would have gone to the hospital,” he said.

Credit…Melissa Bunni Elian for The New York Times

And because the treatments will be given to newly infected people, doctors will need a rapid turnaround in testing to quickly identify patients.

In Regeneron’s case, an antibody test may also be needed to identify patients whose immune systems are not responding. Dr. Yancopoulos acknowledged that such easy and fast tests were not yet widely available, and said that Regeneron was working with Roche to develop tests that could help doctors identify the right patients. In a statement, Roche said it was identifying which of its tests could help in “triaging” patients.

Mr. Ricks, the Eli Lilly chief executive, said his company took testing obstacles into account when it decided to classify high-risk patients based on age and weight. “In a practical clinical setting, it is something that could be applied immediately,” Mr. Ricks said on the recent investor call.

Even after the right patients have been identified, more hurdles await. Patients need to be quickly sent to a clinic or hospital that can administer the treatment, and kept separate from others who are not infected. They will need assistance from medical personnel in protective gear who can insert an intravenous line and monitor them while they are being infused with the drug.

If the antibody treatments prove effective, they are expected to become more widely available by early next year. Regeneron has said it will be able to produce about 250,000 doses a month in partnership with Roche. Eli Lilly has said it will also be able to ramp up production. Another company, AstraZeneca, is also developing an antibody treatment that is earlier in its development, and it has a deal with the federal government to supply up to 100,000 doses by the end of December.

In the meantime, some doctors on the front lines say they are eager for any new tool to keep people out of the hospital.

Dr. Manar Alshahrouri is a critical care doctor in Green Bay, Wis., one of many cities in the Upper Midwest where infections are surging. The intensive care units at the two hospitals in which he works are nearly full, he said. And there’s little to give patients who are newly sick with Covid-19 to prevent them from winding up there. “We don’t have, as of now, anything that is effective,” Dr. Alshahrouri said. “We simply do not.”

But he cautioned that hope for a miracle cure should not be used as a crutch, and it should not replace preventive measures like wearing masks.

Keeping people out of the hospital is “a great endpoint for us as clinicians, but it is not a substitute for far more effective measures,” he said. “If you have a flood in your basement, the answer is not more towels. The answer is to turn off the water.”

Gina Kolata contributed reporting.


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The Trump campaign celebrated a growth record that Democrats downplayed.



The White House celebrated economic growth numbers for the third quarter released on Thursday, even as Joseph R. Biden Jr.’s presidential campaign sought to throw cold water on the report — the last major data release leading up to the Nov. 3 election — and warned that the economic recovery was losing steam.

The economy grew at a record pace last quarter, but the upswing was a partial bounce-back after an enormous decline and left the economy smaller than it was before the pandemic. The White House took no notice of those glum caveats.

“This record economic growth is absolute validation of President Trump’s policies, which create jobs and opportunities for Americans in every corner of the country,” Mr. Trump’s re-election campaign said in a statement, highlighting a rebound of 33.1 percent at an annualized rate. Mr. Trump heralded the data on Twitter, posting that he was “so glad” that the number had come out before Election Day.

The annualized rate that the White House emphasized extrapolates growth numbers as if the current pace held up for a year, and risks overstating big swings. Because the economy’s growth has been so volatile amid the pandemic, economists have urged focusing on quarterly numbers.

Those showed a 7.4 percent gain in the third quarter. That rebound, by far the biggest since reliable statistics began after World War II, still leaves the economy short of its pre-pandemic levels. The pace of recovery has also slowed, and now coronavirus cases are rising again across much of the United States, raising the prospect of further pullback.

“The recovery is stalling out, thanks to Trump’s refusal to have a serious plan to deal with Covid or to pass a new economic relief plan for workers, small businesses and communities,” Mr. Biden’s campaign said in a release ahead of Thursday’s report. The rebound was widely expected, and the campaign characterized it as “a partial return from a catastrophic hit.”

Economists have warned that the recovery could face serious roadblocks ahead. Temporary measures meant to shore up households and businesses — including unemployment insurance supplements and forgivable loans — have run dry. Swaths of the service sector remain shut down as the virus continues to spread, and job losses that were temporary are increasingly turning permanent.

“With coronavirus infections hitting a record high in recent days and any additional fiscal stimulus unlikely to arrive until, at the earliest, the start of next year, further progress will be much slower,” Paul Ashworth, chief United States economist at Capital Economics, wrote in a note following the report.


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Black and Hispanic workers, especially women, lag in the U.S. economic recovery.



The surge in economic output in the third quarter set a record, but the recovery isn’t reaching everyone.

Economists have long warned that aggregate statistics like gross domestic product can obscure important differences beneath the surface. In the aftermath of the last recession, for example, G.D.P. returned to its previous level in early 2011, even as poverty rates remained high and the unemployment rate for Black Americans was above 15 percent.

Aggregate statistics could be even more misleading during the current crisis. The job losses in the initial months of the pandemic disproportionately struck low-wage service workers, many of them Black and Hispanic women. Service-sector jobs have been slow to return, while school closings are keeping many parents, especially mothers, from returning to work. Nearly half a million Hispanic women have left the labor force over the last three months.

“If we’re thinking that the economy is recovering completely and uniformly, that is simply not the case,” said Michelle Holder, an economist at John Jay College in New York. “This rebound is unevenly distributed along racial and gender lines.”

The G.D.P. report released Thursday doesn’t break down the data by race, sex or income. But other sources make the disparities clear. A pair of studies by researchers at the Urban Institute released this week found that Black and Hispanic adults were more likely to have lost jobs or income since March, and were twice as likely as white adults to experience food insecurity in September.

The financial impact of the pandemic hit many of the families that were least able to afford it, even as white-collar workers were largely spared, said Michael Karpman, an Urban Institute researcher and one of the studies’ authors.

“A lot of people who were already in a precarious position before the pandemic are now in worse shape, whereas people who were better off have generally been faring better financially,” he said.

Federal relief programs, such as expanded unemployment benefits, helped offset the damage for many families in the first months of the pandemic. But those programs have mostly ended, and talks to revive them have stalled in Washington. With virus cases surging in much of the country, Mr. Karpman warned, the economic toll could increase.

“There could be a lot more hardship coming up this winter if there’s not more relief from Congress, with the impact falling disproportionately on Black and Hispanic workers and their families,” he said.


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Ant Challenged Beijing and Prospered. Now It Toes the Line.



As Jack Ma of Alibaba helped turn China into the world’s biggest e-commerce market over the past two decades, he was also vowing to pull off a more audacious transformation.

“If the banks don’t change, we’ll change the banks,” he said in 2008, decrying how hard it was for small businesses in China to borrow from government-run lenders.

“The financial industry needs disrupters,” he told People’s Daily, the official Communist Party newspaper, a few years later. His goal, he said, was to make banks and other state-owned enterprises “feel unwell.”

The scope of Mr. Ma’s success is becoming clearer. The vehicle for his financial-technology ambitions, an Alibaba spinoff called Ant Group, is preparing for the largest initial public offering on record. Ant is set to raise $34 billion by selling its shares to the public in Hong Kong and Shanghai, according to stock exchange documents released on Monday. After the listing, Ant would be worth around $310 billion, much more than many global banks.

The company is going public not as a scrappy upstart, but as a leviathan deeply dependent on the good will of the government Mr. Ma once relished prodding.

More than 730 million people use Ant’s Alipay app every month to pay for lunch, invest their savings and shop on credit. Yet Alipay’s size and importance have made it an inevitable target for China’s regulators, which have already brought its business to heel in certain areas.

These days, Ant talks mostly about creating partnerships with big banks, not disrupting or supplanting them. Several government-owned funds and institutions are Ant shareholders and stand to profit handsomely from the public offering.

The question now is how much higher Ant can fly without provoking the Chinese authorities into clipping its wings further.

Excitable investors see Ant as a buzzy internet innovator. The risk is that it becomes more like a heavily regulated “financial digital utility,” said Fraser Howie, the co-author of “Red Capitalism: The Fragile Financial Foundation of China’s Extraordinary Rise.”

“Utility stocks, as far as I remember, were not the ones to be seen as the most exciting,” Mr. Howie said.

Ant declined to comment, citing the quiet period demanded by regulators before its share sale.

The company has played give-and-take with Beijing for years. As smartphone payments became ubiquitous in China, Ant found itself managing huge piles of money in Alipay users’ virtual wallets. The central bank made it park those funds in special accounts where they would earn minimal interest.

After people piled into an easy-to-use investment fund inside Alipay, the government forced the fund to shed risk and lower returns. Regulators curbed a plan to use Alipay data as the basis for a credit-scoring system akin to Americans’ FICO scores.

China’s Supreme Court this summer capped interest rates for consumer loans, though it was unclear how the ceiling would apply to Ant. The central bank is preparing a new virtual currency that could compete against Alipay and another digital wallet, the messaging app WeChat, as an everyday payment tool.

Ant has learned ways of keeping the authorities on its side. Mr. Ma once boasted at the World Economic Forum in Davos, Switzerland, about never taking money from the Chinese government. Today, funds associated with China’s social security system, its sovereign wealth fund, a state-owned life insurance company and the national postal carrier hold stakes in Ant. The I.P.O. is likely to increase the value of their holdings considerably.

“That’s how the state gets its payoff,” Mr. Howie said. With Ant, he said, “the line between state-owned enterprise and private enterprise is highly, highly blurred.”

China, in less than two generations, went from having a state-planned financial system to being at the global vanguard of internet finance, with trillions of dollars in transactions being made on mobile devices each year. Alipay had a lot to do with it.

Alibaba created the service in the early 2000s to hold payments for online purchases in escrow. Its broader usefulness quickly became clear in a country that mostly missed out on the credit card era. Features were added and users piled in. It became impossible for regulators and banks not to see the app as a threat.

ImageAnt Group’s headquarters in Hangzhou, China.
Credit…Alex Plavevski/EPA, via Shutterstock

A big test came when Ant began making an offer to Alipay users: Park your money in a section of the app called Yu’ebao, which means “leftover treasure,” and we will pay you more than the low rates fixed by the government at banks.

People could invest as much or as little as they wanted, making them feel like they were putting their pocket change to use. Yu’ebao was a hit, becoming one of the world’s largest money market funds.

The banks were terrified. One commentator for a state broadcaster called the fund a “vampire” and a “parasite.”

Still, “all the main regulators remained unanimous in saying that this was a positive thing for the Chinese financial system,” said Martin Chorzempa, a research fellow at the Peterson Institute for International Economics in Washington.

“If you can’t actually reform the banks,” Mr. Chorzempa said, “you can inject more competition.”

But then came worries about shadowy, unregulated corners of finance and the dangers they posed to the wider economy. Today, Chinese regulators are tightening supervision of financial holding companies, Ant included. Beijing has kept close watch on the financial instruments that small lenders create out of their consumer loans and sell to investors. Such securities help Ant fund some of its lending. But they also amplify the blowup if too many of those loans aren’t repaid.

“Those kinds of derivative products are something the government is really concerned about,” said Tian X. Hou, founder of the research firm TH Data Capital. Given Ant’s size, she said, “the government should be concerned.”

The broader worry for China is about growing levels of household debt. Beijing wants to cultivate a consumer economy, but excessive borrowing could eventually weigh on people’s spending power. The names of two of Alipay’s popular credit functions, Huabei and Jiebei, are jaunty invitations to spend and borrow.

Huang Ling, 22, started using Huabei when she was in high school. At the time, she didn’t qualify for a credit card. With Huabei’s help, she bought a drone, a scooter, a laptop and more.

The credit line made her feel rich. It also made her realize that if she actually wanted to be rich, she had to get busy.

“Living beyond my means forced me to work harder,” Ms. Huang said.

First, she opened a clothing shop in her hometown, Nanchang, in southeastern China. Then she started an advertising company in the inland metropolis of Chongqing. When the business needed cash, she borrowed from Jiebei.

Online shopping became a way to soothe daily anxieties, and Ms. Huang sometimes racked up thousands of dollars in Huabei bills, which only made her even more anxious. When the pandemic slammed her business, she started falling behind on her payments. That cast her into a deep depression.

Finally, early this month, with her parents’ help, she paid off her debts and closed her Huabei and Jiebei accounts. She felt “elated,” she said.

China’s recent troubles with freewheeling online loan platforms have put the government under pressure to protect ordinary borrowers.

Ant is helped by the fact that its business lines up with many of the Chinese leadership’s priorities: encouraging entrepreneurship and financial inclusion, and expanding the middle class. This year, the company helped the eastern city of Hangzhou, where it is based, set up an early version of the government’s app-based system for dictating coronavirus quarantines.

Such coziness is bound to raise hackles overseas. In Washington, Chinese tech companies that are seen as close to the government are radioactive.

In January 2017, Eric Jing, then Ant’s chief executive, said the company aimed to be serving two billion users worldwide within a decade. Shortly after, Ant announced that it was acquiring the money transfer company MoneyGram to increase its U.S. footprint. By the following January, the deal was dead, thwarted by data security concerns.

More recently, top officials in the Trump administration have discussed whether to place Ant Group on the so-called entity list, which prohibits foreign companies from purchasing American products. Officials from the State Department have suggested that an interagency committee, which also includes officials from the departments of defense, commerce and energy, review Ant for the potential entity listing, according to three people familiar with the matter.

Ant does not talk much anymore about expanding in the United States.

Ana Swanson contributed reporting.


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