Pfizer-BioNTech Vaccine Package Defects Prompt Hong Kong Halt

Hong Kong on Wednesday suspended use of the Pfizer-BioNTech vaccine after packaging defects ranging from cracked containers to loose caps were discovered in one batch of doses, in a major blow to a city already struggling in its campaign to inoculate its seven million residents against Covid-19.

Health officials called the halt a precaution, saying that none of the defective vials had been administered to patients and that they had found no health risks. But if the suspension persists, the Chinese territory may not have enough shots to protect its population while the coronavirus continues to spread. Hong Kong officials were counting on 7.5 million doses of the vaccine, developed by Pfizer of the United States and BioNTech of Germany, to help fill their needs.

The discovery has also unleashed a hunt for the origin of the defects, as well as questions about whether more might be out there. The doses were manufactured at BioNTech’s facilities in Germany, while a Chinese company called Fosun Pharma was in charge of transporting, storing and distributing the shots in Hong Kong.

“I’m confused as to why this is being reported for the first time in Hong Kong and we haven’t heard about it elsewhere,” said Benjamin Cowling, the division head of epidemiology and biostatistics at the University of Hong Kong.

poll of 2,733 residents showed that only 39 percent of Hong Kong residents were willing to take a Covid-19 vaccine.

“There are some important risks here that this will further undermine confidence in the vaccines that are available,” said Karen Grépin, an associate professor at the School of Public Health at the University of Hong Kong, who got the BioNTech shot on March 12.

Professor Grépin said that many Hong Kong residents had been waiting to see what the early stages of the rollout would look like before deciding on taking a vaccine.

The suspension sent a ripple of uncertainty through the city’s clinics and medical offices, as vaccinations shuddered to a halt.

rounded up for quarantine.

It is unclear how soon concerns about the Pfizer-BioNTech vaccine will be cleared up or how quickly Hong Kong can make up for the shortfall. The city has also ordered 7.5 million vaccine doses from the British-Swedish company AstraZeneca, which are set to arrive in the second quarter. The company has not yet applied for approval of its vaccine in Hong Kong.

However quickly the problem is resolved, confusion has been sown.

Ruby Callaghan Brown, 32, and her husband arrived at a vaccination center on the eastern side of Hong Kong Island at 7:45 a.m. on Wednesday, 15 minutes before it opened. A staff member shooed them away, saying all vaccinations had been stopped and that an announcement was coming.

Then they read online that the center had reopened, so they returned. They were about to submit their paperwork when they were told once again that vaccinations were suspended.

They waited 45 minutes before leaving. “I thought, ‘I’m just going to sit here until they change their mind,’” she said.

Elsie Chen contributed research.

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Here Are The High Costs of the Airline Bailouts

Major U.S. airlines have received more than $50 billion in grants in multiple rounds of taxpayer-funded bailouts during the pandemic. As travel begins to rebound and the stock market cruises to record highs, Andrew asks in his latest column: Was the rescue worth it?

The good news: The bailouts probably saved as many as 75,000 jobs and kept the airlines from declaring bankruptcy.

The bad news: Taxpayers probably overpaid, with the original grant of $25 billion implying that each job cost the equivalent of more than $300,000. (That price grew with subsequent bailouts.)

throw money at everything these days, and the Fed’s stimulus kept the credit markets open.

  • U.S. airlines were able to issue more than $30 billion in bonds last year, in some cases backed by their loyalty programs.

  • Boeing and Carnival Cruise Line also raised billions in debt from private investors.

We’ll never know what would have happened without the bailouts. The airlines say the government grants were crucial: As American Airlines put it, they “saved thousands of airline jobs, preserved the livelihoods of our hard-working team members and helped position the industry to play a central role in the nation’s recovery.”

  • There are conditions attached to the rescues, including halting share buybacks and limiting C.E.O. pay. But other things, like stock warrants issued to the government, are worth a small fraction of the grants the airlines received (unlike the majority equity stake that the government took when it rescued G.M. as part of its bankruptcy in 2009).

The debate about the appropriateness of the bailouts is just beginning, Andrew writes. “After the banking crisis of 2008 led to bailouts, the recriminations began when firms like Goldman Sachs had a banner year in the aftermath — and paid bankers record bonuses.” Will the same thing happen to the airlines?

Uber will classify British drivers as “workers.” The ride-hailing service’s decision will entitle more than 70,000 drivers to a minimum wage, vacation pay and access to a pension plan, but stops short of making them employees. It comes in response to a British Supreme Court ruling last month.

Wall Street firms plan for in-office workers. JPMorgan Chase expects summer interns in New York and London to work at the office. And Ralph Schlosstein, the co-C.E.O. of Evercore, told Bloomberg Television that he hoped to have some summer trainees “at least be partly in the office.”

its process for reviewing deals involving drug makers, following an investigation by Representative Katie Porter, Democrat of California, into the impact of consolidation. It’s the latest sign of the Biden administration’s stance on antitrust.

Treasury Department opens a racial equity review. It will examine its policies in an effort to ensure economic fairness, a priority of Treasury Secretary Janet Yellen. The review will be led by Adewale Adeyemo once he is confirmed as deputy Treasury secretary.

The buyer of Jeffrey Epstein’s Manhattan mansion is revealed. Michael Daffey, a former Goldman Sachs executive, paid $51 million for the residence after racking up big gains on Bitcoin.

Amalgamated Bank, the New York-based lender with a history of supporting progressive causes, plans to announce this morning that it will endorse H.R. 40, legislation calling for a federal commission to study the lingering effects of slavery — and the merits of providing reparations.

The lender came to support the bill after racial justice protests last year. Lynne Fox, Amalgamated’s chair and interim C.E.O., told DealBook that the protests convinced the bank’s leaders that they needed to address structural racism with “systemic changes” to society. The bank, which has $6 billion in assets, has previously embraced policies that it said would help reduce gun-related violence.

  • H.R. 40, named after the federal government’s promise to give freed families “40 acres and a mule,” was first proposed over 30 years ago. Its current lead sponsor is Representative Sheila Jackson Lee, Democrat of Texas, and its 169 co-sponsors are all Democrats. (President Biden has endorsed forming a committee to study reparations, but he has not committed to signing the bill should Congress approve it, which isn’t assured.)

A bank’s support is symbolically important, Ms. Fox said: “We acknowledge — and I think others in the financial industry need to acknowledge — the deep-rooted connections between the American financial sector and the slave economy.” Bank executives have noted that their firms’ histories have included financing slaveholders, and admitted more recently to racial discrimination against employees and customers. Lenders are under increasing pressure to promote racial equity, including by shareholders.

  • For her part, Ms. Fox declined to criticize other lenders directly. “We don’t see ourselves as judging other institutions’ conduct,” she said. “Talking is a good first step. We look forward to when other concrete steps are taken.”

Amalgamated has moved to address racial equity within its walls, Ms. Fox said. Those steps include reviewing wage policies, forming an employee-led committee to review policies and practices, and providing antiracism training. In its statement endorsing H.R. 40, Amalgamated pledged to do more: “We believe the commission created through H.R. 40 is an important first step towards achieving racial justice. The work shouldn’t stop there.”


the addition of LeBron James as a co-owner of Fenway Sports Group — the owner of the Red Sox, the English Premier League’s Liverpool soccer club and more — grabbed headlines yesterday, an investment in the group by RedBird Capital Partners may be more noteworthy.

RedBird paid $750 million for an 11 percent stake in F.S.G., at a $7.3 billion valuation. That’s a huge gain for F.S.G.’s existing leaders, John Henry and Tom Werner, who paid just over $1 billion for the Red Sox and Liverpool. It will bring on board Gerry Cardinale, the head of RedBird and a former Goldman Sachs deal maker.

The funds could help the group make big purchases. The Boston Globe reports that F.S.G.’s wish list includes an N.F.L. or N.B.A. team, as well as a sports betting company.

Mr. James is getting a 1 percent stake in F.S.G. without paying a dime, Axios’s Dan Primack reports. The Times notes that the N.B.A. star already had a relationship with F.S.G.: Its affiliate, Fenway Sports Management, gained Mr. James’s global marketing rights in a 2011 deal that gave him a stake in Liverpool.


Work woes may hasten a manager’s demise, according to an academic study on C.E.O. stress, aging and death. The research found that anxiety at work affects an executive’s longevity and looks, and there’s a lesson for all workers, Marius Guenzel of Wharton, one of the authors, told DealBook.

entering and exiting office, showing the aging effects of a very stressful job.

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‘There Was No Mercy’

Amazon faces a unionization drive at a warehouse in Bessemer, Ala. — the largest and most viable U.S. labor challenge in years. The Times’s David Streitfeld looked into the e-commerce giant’s previous efforts to block organized labor. He found a host of tough tactics … that worked. Will they again?

Among Amazon’s steps to oppose a unionization drive in Chester, Va. five years ago, according to regulatory documents and employees:

  • Human resources officials were brought in, and some were accused of following workers to glean their positions on the union drive.

  • Supporters of the effort were described as “a cancer and a disease to Amazon and the facility,” according to Bill Hough Jr., a leader of that organization effort, and a memo from the union sponsoring the effort.

  • Mr. Hough was accused of insubordination and was told he may lose his job if he continued to have a “negative impact.”

  • Mr. Hough’s verdict: “There was no mercy.”

Amazon secretly reached a settlement with the National Labor Relations Board, after the union behind the drive lodged a complaint. The company was required to post notices around the warehouse promising good behavior, though it did not have to admit to labor law violations or pay financial penalties.

Organizers of the Alabama unionization effort say the company has tried similar tactics. Amazon, they assert, tried to surveil employees while posting notices around the Bessemer warehouse bad-mouthing the union. (One claimed workers would need to skimp on dinner to pay union dues.) Management even changed a traffic signal to hinder organizers’ efforts to approach workers.

  • Those accusations prompted President Biden to say that “workers in Alabama” — Amazon wasn’t specifically named — shouldn’t face “intimidation or threats by employers.” Senator Marco Rubio, Republican of Florida, expressed support for Amazon workers, saying the company had “decided to wage culture war against working-class values.”

Union organizers are pessimistic. Nearly 6,000 workers at the Bessemer warehouse have until March 29 to decide whether to join the Retail, Wholesale and Department Store Union. “They will fall to threats or think, ‘I won’t have a job, Amazon will replace me,’” Mr. Hough told The Times. He added, “I’m hoping for the best.” In a statement, Amazon said it did not believe the union push in Alabama “represents the majority of our employees’ views.”

More European countries suspend the use of AstraZeneca’s vaccine. Germany, France, Italy and Spain paused the inoculations amid reports that a handful of recipients had developed blood clots. Medical experts said there was “no evidence” linking the vaccine to increased risk of clots, but the moves could add to the problems of Europe’s vaccination initiatives.

improve vehicle charging times, as well as build six battery factories. One analyst said it served as “a blueprint for what legacy carmakers need to achieve.”

Warren Buffett bucks calls for E.S.G. disclosures. In Berkshire Hathaway’s annual proxy, Mr. Buffett’s conglomerate urged shareholders to reject proposals for more transparency of climate-related risks and diversity and inclusion efforts. It’s a marked contrast to the increasing disclosure into environmental, social and corporate governance issues (more on that below).

The Sackler family may relinquish control of OxyContin’s maker. Purdue Pharma has released its bankruptcy restructuring plan, which includes a pledge from its founding family to pay $4.3 billion — $1.3 billion more than previously offered — to reimburse the costs of the opioid epidemic.

Streaming giants dominate the Oscar race. Netflix collected 35 nominations — led by “Mank,” from the director David Fincher — while Amazon earned 12, as pandemic-driven theater shutdowns bolstered online video services and traditional studios shifted many contenders to next year.

A day after the chairman and C.E.O. of Danone, Emmanuel Faber, stepped down under pressure from activist investors, other shareholders in the French food giant are turning on the activists. CtW, an adviser to union pension funds with over $250 billion in assets, sent a sharply worded letter yesterday to Artisan Partners, which led the revolt over Mr. Faber’s leadership. The twist in the letter, which was reviewed by DealBook, is that CtW owns a “substantial” number of Artisan shares — and said that the fund needs the sort of governance shake-up it pushed for Danone.

Entreprise à Mission,” which allows companies to take greater consideration of social and environmental issues in their business model. Some 99 percent of shareholders backed the move, but not Artisan Partners. Danone’s performance has recently lagged behind competitors like Nestle and Unilever, Artisan said when calling for boardroom changes, including someone other than Mr. Faber becoming chairman.

CtW says Artisan’s own policies are inconsistent with its demands at Danone. Notably, Eric Colson serves as Artisan’s chairman and C.E.O. “Artisan’s call for an independent chair at Danone while maintaining the positions of C.E.O. and chair combined on its own board is inconsistent with best governance practices,” wrote Dieter Waizenegger, CtW’s executive director. He also questioned the firm’s use of “large discretionary cash bonuses” and demanded a discussion with management by the end of the month. Artisan did not respond to a request for comment.


— Ray Dalio of Bridgewater Associates on the state of the markets.


an important speech by Allison Herren Lee, the acting chair of the Securities and Exchange Commission, on environmental, social and governance (E.S.G.) issues. Investors are increasingly demanding more corporate disclosure on these factors, and she suggested that voluntary regimes are not enough. “No single issue has been more pressing for me than ensuring that the S.E.C. is fully engaged in confronting the risks and opportunities that climate and E.S.G. pose for investors, our financial system and our economy,” she said.

We asked Ms. Lee a few more questions about the scope and timing of the agency’s initiatives. Her responses have been edited for clarity and length.

said that an increased focus on E.S.G. “would be a total abuse of power and a politicization of S.E.C.’s disclosure standard.”

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Purdue Pharma Offers Plan to End Sackler Control and Mounting Lawsuits

In a filing that signifies the beginning of the end of the country’s most notorious manufacturer of prescription opioids, Purdue Pharma submitted its bankruptcy restructuring plan just before midnight on Monday. The blueprint requires members of the billionaire Sackler family to relinquish control of the company and transforms it into a new corporation with revenue directed exclusively toward abating the addiction epidemic that its signature painkiller, OxyContin, helped create.

The plan, more than 300 pages long, is the company’s formal bid to end thousands of lawsuits and includes a pledge from the Sacklers to pay $4.275 billion from their personal fortune — $1.3 billion more than their original offer — to reimburse states, municipalities, tribes and other plaintiffs for costs associated with the epidemic.

If the plan is approved by a majority of the company’s creditors and Judge Robert D. Drain of federal bankruptcy court in White Plains, N.Y., payments will start pouring into three buckets: one to compensate individual plaintiffs, like families whose relatives overdosed or guardians of infants born with neonatal abstinence syndrome, as well as hospitals and insurers; another for tribes; and the third — and largest — for state and local governments, which have been devastated by the costs of a drug epidemic that has only worsened during the Covid-19 pandemic.

“With drug overdoses still at record levels, it is past time to put Purdue’s assets to work addressing the crisis,” said Steve Miller, chairman of Purdue’s board of directors, in a statement. “We are confident this plan achieves that critical goal. ”

filed for bankruptcy protection in 2019.

pleaded guilty to federal criminal charges in November for defrauding health agencies and violating anti-kickback laws.

Individual members of the Sackler family agreed to pay the federal government $225 million in civil penalties, but said in a statement that they had “acted ethically and lawfully.” Although the Sacklers were not charged criminally, the Justice Department reserved the right to pursue criminal charges later.

recent public health principles that were signed by at least two dozen major medical, drug policy and academic institutions and that include attention to drug prevention, youth education, racial equity and transparency.

The plan will be voted on by tens of thousands of parties. Confirmation hearings will ensue, and a conclusion is expected in a few months. From the start of the bankruptcy proceedings 18 months ago, leaders of a major bloc of municipalities signaled their support, as did 24 states.

Lloyd B. Miller, who represents numerous tribes including the Navajo Nation, said his clients were on board.

“It’s critical that more opioid treatment funding starts flowing into tribal communities, all the more so given the extraordinary devastation tribes have suffered during the Covid pandemic,” he said.

But since 2019, when Purdue filed for bankruptcy, 24 other states — some controlled by Democrats, others by Republicans — and the District of Columbia have opposed the move, noting that Purdue has continued to profit from its OxyContin sales.

Maura Healey, the attorney general of Massachusetts, who was the first to sue individual members of the Sackler family, contended that under this plan, the Sackler payments would come from their investment returns rather than from principal.

“The Sacklers became billionaires by causing a national tragedy,” Ms. Healey said in a statement. “They shouldn’t be allowed to get away with it by paying a fraction of their investment returns over the next nine years and walking away richer than they are today.”

Attorneys general for the opposing states said that although the plan was an improvement over earlier proposals, they still found it disappointing for several reasons. Among those, they said, the plan should be amended to establish “a prompt and orderly wind-down of the company that does not excessively entangle it with states and other creditors.”

Two branches of the Sackler family — heirs of two of the brothers who founded the company — said: “Today marks an important step toward providing help to those who suffer from addiction, and we hope this proposed resolution will signal the beginning of a far-reaching effort to deliver assistance where it is needed.”

The eldest brother, Dr. Arthur Sackler, sold his shares before OxyContin was introduced and his relatives are not part of the litigation.

A forensic audit of the Sacklers’ finances, commissioned by Purdue in the course of the bankruptcy investigations, determined that from 2008 to 2017 the family earned more than $10 billion from the company. Lawyers for the family said that the full amount was not liquid: More than half went toward taxes and investments in businesses that will be sold as part of the bankruptcy agreement.

Although states and other blocs of creditors have vociferously objected to elements of the plan for 18 months, many factors seem to favor the likelihood of approval: the duration of the litigation, the exorbitant cost to all parties, the urgency of the worsening opioid crisis and the overall depletion of public health resources by the coronavirus pandemic.

The new company would continue to sell OxyContin, a painkiller that is still approved by the Food and Drug Administration under limited circumstances. But it would diversify its products to include generics and a drug to treat attention deficit hyperactivity disorder, as well as set aside new drugs to reverse overdoses and treat addiction, to be distributed on a nonprofit basis as a public health initiative.

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Extended Stay America to Be Acquired for $6 Billion: Live Updates

the hotel operator Extended Stay America for $6 billion, the latest deal premised on a post-pandemic rebound in travel.

The deal is a bet that the mid-tier hotel chain that provides guests with amenities like kitchens and laundry facilities will prosper as the U.S. economy recovers. The chain had a 74 percent occupancy rate last year, above the industry average, with many rooms filled by essential workers.

The company’s new owners hope those rooms will soon add more tourists and traveling professionals. Extended Stay has about 600 locations across the United States.

“Our occupancy levels across the brand now rival the pre-Covid levels,” Bruce Haase, Extended Stay’s chief executive, told analysts on the company’s earnings call last month. “And unlike the rest of the industry that was still reaching for occupancy, we can now turn much of our attention to driving higher rates.”

The company’s shares have more than doubled over the past year, and the acquisition offer is a 15 percent premium to its closing stock price at the end of last week.

Starwood and Blackstone both have experience investing in hospitality, and Blackstone has even owned Extended Stay before — twice. It acquired the company for $3.1 billion in 2004, before selling it three years later for $8 billion. It was also part of a consortium that bought the business out of bankruptcy in 2010, outbidding a group led by Starwood Capital. Extended Stay then went public in 2013.

Other private equity firms have similarly bet on a recovery of the hospitality industry. Apollo Global Management announced plans this month to join with Vici Properties to acquire the Venetian hotel and casino in a $6.25 billion deal that also includes the Las Vegas property’s large expo center.

A photo illustration of a Stripe logo on a smartphone.
Credit…Pavlo Gonchar/Sipa, via Associated Press

The payments company Stripe is worth $95 billion after a new round of funding, making it the most valuable start-up in the United States.

The San Francisco and Dublin-based company said on Sunday that it had raised $600 million in new funding from investors including Sequoia Capital, Fidelity Management and Ireland’s National Treasury Management Agency. The investment nearly triples Stripe’s last valuation of $35 billion.

The funding comes amid a surge in the adoption of digital tools and services in the pandemic as more people live, work and make purchases online. That has fueled a wave of investment into, and eye-popping valuations at, tech start-ups, as well as a frenzy of highly valued initial public offerings. Investors have valued Airbnb, the home rental start-up that recently went public, at $123 billion. Roblox, a kids gaming start-up, saw its valuation soar to $45 billion when it went public last week.

Founded in 2010, Stripe builds software that enables businesses to process payments online. As more people have turned to online shopping in the pandemic, Stripe’s offerings have been in demand. It is the largest among a class of fast-growing, highly valued financial technology companies.

Stripe is now processing hundreds of billions of dollars in payments each year across 42 countries, Dhivya Suryadevara, Stripe’s chief financial officer, said in an interview. “We are in a hyper-growth industry and within that, the company itself is experiencing hyper-growth,” she said. Ms. Suryadevara declined to share specifics on Stripe’s revenue or growth.

Credit…Richard Drew/Associated Press

Stripe has been considered a candidate to go public. Coinbase, another financial technology start-up, filed to go public later this month in a transaction that some expect could hit $100 billion. Robinhood, a stock trading app, has also seen its valuation surge in the pandemic.

Stripe said in an announcement that it planned to use the money to expand in Europe, including its office in Dublin. The company’s sibling founders, John Collison, 30, and Patrick, 32, were born in Ireland.

In a statement, John Collison, Stripe’s president, said the company would focus heavily on Europe this year. “The growth opportunity for the European digital economy is immense,” he said.

The company, which got its start working with start-ups and small businesses, will also invest in building more tools to help larger businesses handle payments. It counts 50 businesses that process more than $1 billion a year as customers.

Gene Sperling at the White House in 2013.
Credit…Chip Somodevilla/Getty Images

President Biden has tapped Gene Sperling, a longtime top economic aide to Democratic presidents, to oversee spending from the $1.9 trillion relief package that the president signed into law last week and planned to promote across the country this week.

Mr. Sperling was director of the National Economic Council under President Bill Clinton and President Barack Obama. In Mr. Obama’s administration, where he first served as a counselor in the Treasury Department, Mr. Sperling helped to coordinate a bailout of Detroit automakers and other parts of the administration’s response to the 2008 financial crisis.

He advised Mr. Biden’s campaign informally in 2020, helping to hone the campaign’s “Build Back Better” policy agenda. He will serve as the White House American Rescue Plan coordinator and as a senior adviser to Mr. Biden.

His appointment could be announced as soon as today. Mr. Biden is scheduled to give remarks on the implementation of his relief bill, known as the American Rescue Plan, on Monday afternoon. The White House press secretary, Jen Psaki, told reporters last week that Mr. Biden intended to appoint someone to “run point” on implementing the plan — a role that Mr. Biden held for the Obama administration’s $800 billion stimulus plan in 2009.

Mr. Sperling did not respond to a message seeking comment. Friends have described him in recent months as eager to join the administration, and he had been mentioned as a possible appointee to head the Office of Management and Budget after Mr. Biden’s first nominee for that position, Neera Tanden, withdrew amid Senate opposition. His appointment was reported earlier by Politico.

Mr. Sperling’s challenge with the rescue plan will be different than the one Mr. Biden faced in 2009, because the relief bill that Mr. Biden just signed differs starkly from Mr. Obama’s signature stimulus plan. The Biden plan is more than twice as large as Mr. Obama’s, and it centers on a wide range of payments to low- and middle-income Americans, including $1,400-per-person direct checks that Treasury officials started sending electronically to Americans over the weekend. It includes money meant to hasten the end of the Covid-19 pandemic, including billions for vaccine deployment and coronavirus testing.

But the plans also have similarities, including more than $400 billion each in total spending for school districts and state and local governments.

An administration official said Mr. Sperling would work with White House officials and leaders of federal agencies to hasten the delivery of the money, including partnering with state and local governments on their shares of relief spending from the bill.

The Maryland hotel executive Stewart W. Bainum Jr. had been planning to create a nonprofit group that would buy The Baltimore Sun.
Credit…Andrew Gombert/European Pressphoto Agency

A deal that would reshape the American newspaper industry has run into complications just one month after an agreement was reached, according to three people with knowledge of the matter.

As a result, the New York hedge fund Alden Global Capital may have to fend off a new suitor for Tribune Publishing, the chain that owns major metropolitan dailies across the country, including The Chicago Tribune, The Daily News and The Baltimore Sun, the people said.

On Feb. 16, Alden, the largest shareholder in Tribune Publishing, with a 32 percent stake, reached an agreement to buy the rest of the chain in a deal that valued the company at $630 million, reports The New York Times’s Marc Tracy. In the deal, Alden would take ownership of all the Tribune Publishing papers — and then spin off The Sun and two smaller Maryland papers, selling them for $65 million to a nonprofit organization controlled by the Maryland hotel magnate Stewart W. Bainum Jr.

In recent days, Mr. Bainum and Alden have found themselves at loggerheads over details of the operating agreements that would be in effect as the Maryland papers transitioned from one owner to another, the people said. In response, Mr. Bainum has taken a preliminary step toward making a bid for all of Tribune Publishing, the people said.

Mr. Bainum has asked a special committee of the Tribune Publishing board made up of three independent directors for permission to be released from a nondisclosure agreement prohibiting him from discussing the deal, so that he would be able to pursue partners for a new bid, the people said.

A spokeswoman for Mr. Bainum said he had no comment. Through a spokesman, Tribune Publishing’s special committee declined to comment. An Alden spokesman had no comment.

The pharmaceutical industry is popular right now, which is perhaps unsurprising considering that the end of the pandemic depends on Covid-19 vaccines. Drug makers’ rapid response to the crisis has transformed public sentiment about the industry, moving it from one of the most reviled to one of the most respected, according to new data from the Harris Poll, reported first in the DealBook newsletter.

A year of living in existential and economic fear created unlikely heroes. For the past year or so, the Harris Poll has monitored public sentiment in weekly surveys of more than 114,000 people. At the height of the emergency, more than half of respondents were afraid of dying from the virus and a similar share were afraid of losing their jobs. “Only in the past month, with vaccines rising and hospitalizations and deaths declining, is fear abating,” the report noted.

Business generally got good grades during the pandemic. Many respondents cited companies as important to solving problems, where previously they were considered the cause of social woes. Two-thirds said that companies could do a better job coordinating the vaccine rollout than the government could.

Approval ratings rose for many industries from January last year to February this year. But the reputation of the pharma industry — stained by its role in the opioid crisis and criticized for high drug prices — benefited the most. In January 2020, only 32 percent of respondents viewed the industry positively; late last month, that had almost doubled, to 62 percent.

“The pharmaceutical industry’s ability to innovate and perform under intense pressure and in a time of crisis is the ultimate validation for any business,” said John Gerzema, the chief executive of the Harris Poll.

The Tesla car manufacturing plant in Fremont, Calif., remained open during the pandemic despite restrictions put in place by local officials.
Credit…Jim Wilson/The New York Times

More than 400 workers at a Tesla plant in California tested positive for the coronavirus between May and December, according to public health data released by a transparency website.

The data provides the first glimpse into virus cases at Tesla, whose chief executive, Elon Musk, had played down the severity of the pandemic and reopened the plant, in Fremont, Calif., in May in defiance of guidelines issued by local public health officials.

Automakers across the country halted production and closed plants for two months last year from mid-March until mid-May. After resuming production, other automakers publicly announced when workers had tested positive for the virus and halted production to prevent further infection among employees and to disinfect work areas.

Tesla, however, has released little information about employee coronavirus cases.

The data was obtained by the website PlainSite, which works to make legal and governmental documents publicly accessible. It showed that 440 cases were reported at the Tesla plant, which employs some 10,000 people. The number of cases rose to 125 in December from fewer than 11 in May.

A year ago, after officials in California ordered manufacturing plants to close, Mr. Musk suggested on Twitter that the measure was unnecessary and that cases in the United States would be “close to zero.”

He also called virus restrictions “fascist,” threatened to move Tesla out of California, and then reopened the plant a week before health officials said it was safe to do so. More recently, Mr. Musk has questioned on Twitter the effectiveness of Covid vaccines.

Allison Herren Lee, the S.E.C.’s acting chair, will say that corporate disclosures on E.S.G. issues are a high priority.
Credit…Erin Scott/Reuters

Allison Herren Lee was named acting chair of the Securities and Exchange Commission in January, and she has been active since, especially when it comes to environmental, social and governance issues.

The agency has issued a flurry of notices that such disclosures will be priorities this year. On Monday, Ms. Lee, who was appointed as a commissioner by President Donald J. Trump in 2019, is speaking at the Center for American Progress, where she will call for input on additional E.S.G. transparency, according to prepared remarks reviewed by the DealBook newsletter.

The supposed distinction between what’s good and what’s profitable is diminishing, Ms. Lee will argue in the speech, saying that “acting in pursuit of the public interest and acting to maximize the bottom line” are complementary.

The S.E.C.’s job is to meet investor demand for data on a range of corporate activities. “That demand is not being met by the current voluntary framework,” she will say. “Human capital, human rights, climate change — these issues are fundamental to our markets, and investors want to and can help drive sustainable solutions on these issues.”

Ms. Lee will also argue that “political spending disclosure is inextricably linked to E.S.G. issues,” based on research showing that many companies have made climate pledges while donating to candidates with contradictory voting records. The same goes for racial justice initiatives, she will say.

Although Ms. Lee is only the acting chief, she’s laying the groundwork for more action, based on recent statements by Gary Gensler, President Biden’s choice to lead the S.E.C. In his confirmation hearing this month, Mr. Gensler said that investors increasingly wanted companies to disclose risks associated with climate change, diversity, political spending and other E.S.G. issues.

Not everyone at the S.E.C. is on board. Hester Peirce and Elad Roisman, fellow commissioners also appointed by Mr. Trump, recently protested the “steady flow” of climate and E.S.G. notices. They issued a public statement, asking, “Do these announcements represent a change from current commission practices or a continuation of the status quo with a new public relations twist?”

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Source: Factset


Stocks on Wall Street were little changed on Monday after closing at a new high on Friday. Most European stock indexes were higher.

The yield on 10-year Treasury notes, a key driver of stock market movement lately, fell to 1.61 percent on Monday. It had climbed as high as 1.64 percent on Friday, a level not seen since February 2020, as investors considered whether a nearly $1.9 trillion stimulus package would be inflationary alongside an expected economic recovery as more Americans are vaccinated.

But on Sunday, Janet L. Yellen, the Treasury secretary, pushed back against these concerns. “Is there a risk of inflation? I think there’s a small risk and I think it’s manageable,” she said on ABC. She added that she expected prices to rise over the spring and summer but only temporarily because of how much they fell last year.

“We have had very well-anchored inflation expectations and a Federal Reserve that’s learned about how to manage inflation,” Ms. Yellen said.

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The S.E.C. Is Increasingly Making E.S.G. a Priority

Allison Herren Lee was named acting chair of the Securities and Exchange Commission in January, and since then she has been active, especially when it comes to environmental, social and governance, or E.S.G., issues. The agency has issued a flurry of notices that such disclosures will be priorities this year. Today, Ms. Lee, who was appointed as a commissioner by President Donald Trump in 2019, is speaking at the Center for American Progress, where she will call for input on additional E.S.G. transparency, according to prepared remarks seen by DealBook.

The supposed distinction between what’s good and what’s profitable is diminishing, Ms. Lee will argue in the speech, saying that “acting in pursuit of the public interest and acting to maximize the bottom line” are complementary. The S.E.C.’s job is to meet investor demand for data on a range of corporate activities, and Ms. Lee’s planned remarks suggest that greater transparency on E.S.G. issues won’t be optional for much longer. “That demand is not being met by the current voluntary framework,” she will say. “Human capital, human rights, climate change — these issues are fundamental to our markets, and investors want to and can help drive sustainable solutions on these issues.”

  • Ms. Lee will also argue that “political spending disclosure is inextricably linked to E.S.G. issues,” based on research showing that many companies have made climate pledges while donating to candidates with contradictory voting records. The same goes for racial justice initiatives, she will say.

This is not an interim priority. Ms. Lee is acting chief, but based on recent statements by Gary Gensler, President Biden’s choice to lead the S.E.C., she’s laying the groundwork for more action rather than throwing down the gauntlet. In his confirmation hearing this month, Mr. Gensler said that investors increasingly wanted companies to disclose risks associated with climate change, diversity, political spending and other E.S.G. issues.

Not everyone at the S.E.C. is on board. Hester Peirce and Elad Roisman, fellow commissioners also appointed by Mr. Trump, recently protested the “steady flow” of climate and E.S.G. notices. They issued a public statement, asking, “Do these announcements represent a change from current commission practices or a continuation of the status quo with a new public relations twist?”

Speaker Nancy Pelosi and Representative Alexandria Ocasio-Cortez suggested, to varying degrees, that the governor of New York consider resigning over allegations of sexual harassment. He has rejected those calls and is considering running for a fourth term.

The U.S. is considering new ways to protect itself against cyberattacks. Efforts by China and Russia to breach government and corporate computer networks — and the failure of American intelligence to detect them — have spurred discussions about ways to organize U.S. cyberdefenses, including more partnerships with private companies.

Credit Suisse is accused of continuing to help Americans evade taxes. The Swiss bank aided clients in hiding assets, seven years after it promised U.S. federal prosecutors that it would stop doing so, according to a whistle-blower report. That puts the firm at risk of a fresh investigation and more financial penalties. The bank said it was cooperating with the authorities.

A veteran Democratic official is poised to join the Biden administration. Gene Sperling, an economic wonk who served in the Clinton and Obama administrations, is likely to oversee the implementation of the $1.9 trillion stimulus plan, Politico reports.

Stripe is now Silicon Valley’s most valuable start-up. The payments processor has raised funding from investors like Sequoia and Fidelity at a $95 billion valuation. Stripe plans to use the money to expand in Europe, including in its founders’ home country, Ireland.

chief counsel of the cryptocurrency exchange Coinbase before joining the O.C.C. But his enthusiasm isn’t based on Bitcoin’s success as much as on his personal struggles, he told DealBook.

Mr. Brooks borrowed his way out of an ailing town. He grew up in Pueblo, Colo., a steel center that lost its purpose in the 1980s. His father took his own life when Mr. Brooks was 14, and he and his mother had little. In high school, he waited tables and took out loans for school, for a car and eventually for a home. Now, he’s betting that blockchain can help the underbanked do the same more easily.

“Unlocking credit availability allows people to move up the ladder,” Mr. Brooks said. Nearly 50 million Americans don’t have credit scores, but many are creditworthy. Traditional rating systems aren’t equipped for nuanced assessments that might include things like rent, Netflix bills or income from gig work. For many, the inability to borrow limits opportunities to achieve financial security.

Finding solutions to financial inclusion that are immune to politics is key, noted Mr. Brooks, a Trump administration appointee. Credit, he argues, lets people bet on themselves regardless of which party is making policy, and the current system excludes many worthy borrowers. “Let’s let more people climb ladders,” Mr. Brooks said.


— Howard Lindzon, an investor, entrepreneur and market commentator, speaking to The Times’s Erin Griffith on the booms (or bubbles) in everything from trading cards to Bitcoin, SPACs and so-called meme stocks.


new data from the Harris Poll, revealed exclusively in DealBook.

A year of living in fear created unlikely heroes. For the past year or so, the Harris Poll has monitored public sentiment in weekly surveys of more than 114,000 people. At the height of the emergency, more than half of respondents were afraid of dying from the virus and a similar share were afraid of losing their jobs. “Only in the past month, with vaccines rising and hospitalizations and deaths declining, is fear abating,” the report noted.

The Times’s Opinion podcast “Sway,” the economist Mariana Mazzucato told Kara Swisher that the traditional narrative has holes in it.

“Do you have any idea where the innovation in places like Silicon Valley came from?” asked Ms. Mazzucato, the founder of University College London’s Institute for Innovation and Public Purpose. She ticked off technologies like the internet and GPS: “We wouldn’t have any smart product without all the smart technology, which was government-financed.”

Listen to the conversation here.

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Special Report: Insider alleges Eli Lilly blocked her efforts to sound alarms about U.S. drug factory

(Reuters) – On a chilly spring morning in 2019, Amrit Mula arrived in her office at pharmaceutical giant Eli Lilly and Co’s factory in Branchburg, New Jersey, to find a desk drawer open that she had kept locked. Her files were missing.

FILE PHOTO: An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar

Mula was a top human resources officer at what was one of America’s largest biotech plants. Over the years, she had been investigating employee complaints about manufacturing problems related to multiple drugs, including the company’s blockbuster diabetes medication, Trulicity, according to internal company documents and email correspondence reviewed by Reuters.

Among the most serious allegations: Records had been falsified or destroyed in the wake of manufacturing mistakes. In one case, according to 2018 emails among executives, company-mandated quality assurance documents were missing for Trulicity, which security filings show garnered more than $4 billion in sales in 2019.

Shortly after Mula discovered her files missing that day, her boss told her that Lilly was eliminating her position at the Branchburg plant, where she had worked nearly 15 years, according to a confidential “demand” letter from Mula’s lawyers to Lilly’s attorneys dated Dec. 30, 2019.

The letter, which seeks unspecified damages, portrays Mula as a good-faith whistleblower who repeatedly pressed her superiors to address serious problems at the factory, including staffing shortages, poor training, and record destruction and falsifications. Her inquiries, according to the letter and internal correspondence, were downplayed, ignored and sometimes blocked.

When she persisted, Lilly responded by “marginalizing, harassing and eventually terminating” her, according to the demand letter. Mula has not sued her former employer.

Reuters could not independently verify every claim in the letter. However, based on internal correspondence and other company documents reviewed by reporters, Mula repeatedly received complaints and raised concerns about everything from quality control to record-keeping with a host of Lilly managers and executives. Three former factory workers who spoke to Reuters on condition of anonymity said such problems were endemic at Branchburg, and U.S. Food and Drug Administration inspectors later identified some of the same concerns there.

“I was just doing my job,” Mula told Reuters, declining to comment further.

The demand letter and supporting documentation offer a rare look inside a Big Pharma company – one of the world’s largest – as it struggles with allegations of serious manufacturing violations, which can occur behind the scenes without being promptly investigated and addressed by a company or the FDA.

The pharmaceutical industry has become increasingly reliant on high-priced biologic drugs, like those made at Branchburg, for its profits. Made from living organisms, biologics are difficult and expensive to produce, and batches are particularly prone to microbial contamination.

In a statement, Lilly spokeswoman Kathryn Beiser said the company has “rigorous” quality assurance systems in place and welcomes feedback from employees.

Lilly is working closely with the FDA to address concerns about the factory, Beiser said, and the drugmaker voluntarily conducted a retrospective five-year review that found no impact on Branchburg’s product quality.

Lilly has “long-standing policies and procedures that enable – and encourage – individuals to come forward with information about any potential issues or concerns without fear of retribution,” Beiser said. “We are continuously strengthening and reinforcing a culture where our employees can be proud of our work, so in turn, doctors and patients can trust Lilly’s products have been ethically, properly, and safely manufactured.”

Beiser did not specifically address the issues raised by Mula.

On Tuesday, several days after receiving detailed questions from Reuters, Lilly announced the retirements of two senior vice presidents: Myles O’Neill, who heads Lilly’s manufacturing operations, and Melissa Barnes, who is chief ethics and compliance officer.

Beiser said the retirements were “long planned changes that reflect Lilly’s robust succession planning process” and that the company is grateful for the executives’ “tremendous” contributions. O’Neill and Barnes did not reply to emails seeking comment.

The internal Lilly documents portray a plant where a worker complained in capital letters about being “TIRED AND OVERBURDENED”; where substandard chemicals and ingredients were simply discarded and not reported as required; where safety hazards included the risk of electrocution from live wires; and where quality assurance records disappeared or were doctored. In one case, according to a 2018 email among managers, workers sifted through the garbage to find missing manufacturing records.

The FDA requires pharmaceutical companies to closely track such documents, including recording any deviations from mandated procedures. The record-keeping requirements are key to ensuring the quality of drugs, as defects may not be obvious to consumers or physicians, pharmaceutical and regulatory experts told Reuters. The FDA also requires companies to hire enough staff members and properly train them to ensure compliance with regulations.

As associate director of HR and employee relations since 2011, Mula was tasked with investigating workplace issues including manufacturing complaints. In doing so, she repeatedly encountered a lack of cooperation or pushback from her bosses, according to contemporaneous emails, Mula’s handwritten meeting notes and excerpts from an internal retaliation complaint she filed with the company in December 2018.

“I submit that (executives’) motivation was to discredit and deter me from completing the investigations that were yielding unfavorable results,” she wrote in the internal complaint, which was excerpted in the February 19, 2019, email to her direct supervisor.

At times, her bosses acted on her recommendations or said they would pass her concerns up the management chain, according to internal correspondence.

But the problems largely remained. Months after Mula left, FDA inspectors cited some of the same lapses she had flagged during her tenure and described in her demand letter. For instance, the inspectors found that on several occasions when serious manufacturing quality problems occurred – including in the case of Trulicity ingredients – “the firm failed to conduct a detailed investigation,” according to an August 21, 2020, FDA report.

Overall, the FDA classified its inspectors’ findings at the plant as “Official Action Indicated” or OAI, the most serious category of violations, according to FDA correspondence and reports reviewed by Reuters. If the problems aren’t corrected, an OAI finding can lead to the FDA’s prohibiting the sale of drugs made at the facility, drug quality experts told Reuters. The finding is the most serious sanction Lilly has received in about 12 years and is issued in only 7% of U.S. plant inspections, according to FDA records. The agency has not taken further public action.

Even so, the FDA announced last year that an antibody drug made at the Lilly plant called bamlanivimab could be used to treat COVID-19 on an emergency basis. After its inspections at Branchburg, the FDA required an independent lab to test batches of the treatment made there.

The FDA declined to comment, saying it does not usually discuss its dialogue with individual companies. The inspection reports reviewed by Reuters were heavily redacted by the agency to protect the company’s trade secrets and financial information.

Three outside experts who reviewed the FDA inspection records for Reuters said such manufacturing violations could erode the potency, purity or safety of drugs. It’s crucial to log the processing temperatures and times of drugs and what raw materials are used, said Susan Bain, an assistant professor of regulatory and quality sciences at the University of Southern California who once conducted FDA factory inspections.

Based on her review of the FDA inspection records, she described the quality assurance at the Branchburg plant as “so wildly out of control it’s scary.”

“Ultimately, you don’t know what the heck went on,” Bain added.

RISING DEMAND, SHRINKING STAFF

Lilly’s factory in Branchburg sits at an epicenter of U.S. drug manufacturing, with many of the company’s competitors close by.

Mula went to work there in 2004, when the plant was owned by ImClone Systems, then embroiled in an insider trading scandal involving celebrity businesswoman Martha Stewart. Four years later, Eli Lilly bought the company and the plant for $6.5 billion.

Slideshow ( 2 images )

Ever since, the biologics produced in Branchburg have become increasingly important to Lilly’s bottom line. Biologics are not as easily copied by competitors as conventional pharmaceuticals are and therefore can stay profitable longer.

Lilly developed Trulicity as Type-2 diabetes diagnoses exploded worldwide. The widely advertised medicine, introduced in 2014, is prescribed to help lower blood glucose levels and reduce, or avoid, the need for regular insulin injections. Trulicity, which is injected weekly, also may help with weight loss, according to a Lilly promotional website.

After David Ricks became CEO in 2017, he sought to cut costs through a global reduction of about 3,500 employees – roughly 8% of Lilly’s staff. Many employees took early retirements, and a top quality control official at the New Jersey plant departed.

Fewer and fewer employees at the Branchburg plant were available to prepare critical ingredients used in manufacturing drugs, three people who worked in the plant told Reuters. In addition, many workers were assigned tasks above their experience and training levels, they said.

Ricks referred Reuters questions to a Lilly spokesperson.

The process of manufacturing biologics is complex and delicate; every step and ingredient is tightly controlled. The drugs start as cells in large vats where they are fed ingredients to help them multiply. Then the batches are purified in a series of containers with substances to make them suitable for human absorption. Workers in sterile areas are required to wear protective gear covering their entire bodies. Even skin cell flaking was cited as a possible source of contamination at Branchburg, according to a 2018 employee complaint.

Critical tasks often required at least two people – one to perform a step and another to verify it was done correctly. In some cases, workers reported they didn’t have supervisors to check with on how to properly handle contamination or disposal of unusable materials.

‘STOP THIS STUPIDITY’

By 2018, serious complaints from factory workers and allegations of manufacturing violations were piling up on Mula’s desk, the internal Lilly records reviewed by Reuters show.

On Aug. 9, an anonymous employee called Lilly’s ethics and compliance hot line to report that inadequate staffing and high turnover was a problem at Branchburg, leading to a “heightened stressful environment because employees are handling multiple jobs at once,” according to a complaint recorded by the hot line call center.

Around the same period, emails show, Mula was notified that contamination or other errors in at least nine instances led ingredients or other materials to be discarded. According to the emails, Mula suspected in some cases that the items were improperly disposed of or “dumped” inside the factory.

Two of the 2018 incidents involved Trulicity, Mula told her supervisor, Richard Ruth, in emails the following February. Altogether, Mula said at least $2 million in materials for various drugs were lost to dumping, according to an email she sent to a human resources superior, Efraim Ortiz, whom she thanked for confirming that number.

Both Ortiz and Ruth declined to comment and referred questions to a company spokesperson.

On Oct. 1, 2018, Mula received the complaint from an unidentified factory employee in all-caps via interoffice mail, beseeching her for help.

“WE ARE TIRED AND OVERBURDENED AND DON’T HAVE ENOUGH PEOPLE WORKING ON THE FLOOR,” it said. “PLEASE SUPPORT US AND STOP THIS STUPIDITY.”

On October 11, Mula asked a quality assurance official in an email if her unit had enough staff. The response: “No.”

In her statement, Lilly spokeswoman Beiser said the company ensures that the staffing at all its sites is appropriate, and Branchburg has seen only marginal variations in staffing levels over the past six years. She did not disclose specific figures.

Then-plant manager Victor Cruz and other Branchburg executives pledged at times to cooperate with Mula’s multiple inquiries, the email correspondence shows. But some of the executives also suggested to Mula that there wasn’t a quality problem at the plant, or advised her to let officials in Lilly’s dedicated quality unit resolve the matters.

“We would not proceed with executing any manufacturing operation if we did not have the trained staff to perform that operation,” Liz Gosen, then Branchburg’s vice president of manufacturing operations, wrote to Mula in an October 2018 email. “This would be a violation of our procedures.”

Mula also raised her concerns about staffing in an October meeting with Lilly’s vice president of quality, Leanne Hickman, according to emails between the two.

That same day, plant manager Cruz told Ruth he could no longer work with Mula, emails show. Later, Mula heard that Cruz had announced at a company party that she was going to be reassigned or removed, according to the emails.

Two other managers also had filed complaints against Mula, accusing her of badmouthing her superiors and spreading rumors about an interoffice affair, the emails show.

Ruth later acknowledged in emails to Mula that the managers’ complaints had been unfounded and were dismissed.

It was “determined that there was no violation and no further action regarding the allegations that were brought forward against you” was needed, Ruth wrote in December 2018.

Cruz and Hickman did not respond to requests for comment. Gosen declined to comment.

On Oct. 22, an associate director at the plant emailed Mula and two others to report that records of a Trulicity manufacturing upgrade were missing. Looking for the records entailed “climbing and sifting through garbage,” the associate director said.

By then, turbocharged global demand had vaulted Trulicity over three other Lilly drugs – including erectile dysfunction medicine Cialis – to become the company’s best seller.

COMING TO A HEAD

The pressure on Mula mounted.

In February 2019 emails, a senior manufacturing executive, Darin Moody, told factory managers that he had to attest to “material compliance” with Lilly’s “Red Book” code of conduct and company policies.

However, Mula emailed Ruth and Nellie Clark, who had replaced Cruz as plant manager, on Feb. 5, saying that she “cannot with integrity confirm that all (Branchburg) cases have been escalated as appropriate” by the senior leadership team at the plant.

Mula brought up what she called “one reckless example” in January 2019 that had not been investigated: wet mopping around live electrical wires, posing a risk of electrocution.

“The fact that the event didn’t result in a fatality is shocking,” Mula wrote.

Mula told Ruth she was “excluded” from a meeting with the plant leaders about the incident.

“I would ask that you permit me to do my job and examine the situation despite anticipated rebuffs from Nellie (Clark) and Efraim (Ortiz),” she wrote to Ruth.

Initially, plant managers recommended “verbal” coaching for the employees involved. Ultimately, Mula successfully pushed for written warnings, the emails show.

In email correspondence that February, Mula told Ruth that the upper-level Branchburg managers were not providing detailed information that she needed to conduct her inquiries.

Clark did not respond to requests for comment.

On Feb. 28, 2019, Ruth emailed Mula some positive news.

Ruth told Mula that she “sufficiently” met expectations and would be receiving a bonus. In a later email, he complimented Mula on her work on the electrical wires investigation: “Well done, Amrit.”

Around the same time, however, plant manager Clark told Mula she was “displeased” with Mula’s findings of violations and recommendations for discipline, according to Mula’s demand letter.

Shortly afterward, according to the letter, Mula met three Lilly scientists who alleged that the company discarded a batch of Trulicity worth $8 million to $10 million after data falsification led to contamination during manufacturing. The letter says Clark responded in a mid-March meeting: “We don’t want to mess with Trulicity.” Clark then threatened to remove Mula from her position at the Branchburg plant, the demand letter alleges.

Reuters could not independently confirm the mass discarding of Trulicity or Clark’s comments about the drug or Mula.

On March 28, the day Mula found her files gone, Ruth flew into Branchburg from Lilly’s Indianapolis headquarters, according to email and instant messages he sent to Mula at the time. Once there, he told her that her position was being eliminated.

According to a March 28 notification letter Mula received from the company, the job was being eliminated due to a need to reallocate resources “to compete in a new business environment.” Mula was offered a roughly $96,000 severance and the opportunity to apply for another position, according to the March 28 letter and her demand letter.

ENTER THE FEDS

In November 2019, eight months after Mula’s dismissal, FDA inspectors showed up at the plant for a routine inspection.

Among a host of problems cited by the inspectors: The company did not keep proper records to verify that its quality management systems were operating in compliance with FDA regulations – a concern Mula had been raising for more than two years.

The FDA red-flagged the problems with its “Official Action Indicated” designation.

On a subsequent inspection that began in July 2020, the FDA discovered signs that Lilly was systematically downplaying significant manufacturing problems, said Peter Calcott, a pharmaceutical consultant and instructor at the extension program of the University of California, Berkeley, among those who reviewed the FDA records for Reuters.

“As a patient, I’m more worried about that,” Calcott said.

In July 2020, for instance, FDA inspectors found that when the plant’s tests of a migraine treatment drug called Emgality showed problems, the plant repeated those tests until it got the results needed to finish the manufacturing process, according to the FDA documents reviewed by Reuters.

During that same inspection, the FDA found that Lilly discarded a batch of drug ingredients that had been used incorrectly in May 2020, without investigating the matter or keeping proper records. It is not possible to tell from the redacted documents which drug was at issue.

The company’s vice president of manufacturing, who is not named in the FDA report, told the agency that the workers responsible “are no longer employed with the firm” due to “the severity of the issue,” the inspectors wrote.

FDA investigators said that the May incident and lack of follow-up investigation was not an “isolated occurrence,” as they said Lilly had claimed. They cited three similar instances in 2020 alone and could not determine whether the company had addressed the problems, according to their August inspection report.

In September, a month after the FDA inspection, Lilly drew up internal talking points to brief employees on the agency’s findings and remind them how to comply with regulations. Workers were instructed, for instance, not to use informal record-keeping such as “sticky notes.”

Lilly asserted in the briefing that it had made “tremendous progress.” If problems arise again, the company advised employees, “speak up.”

Marisa Taylor reported from Washington, D.C.; Dan Levine from San Francisco. Editing by Michele Gershberg and Julie Marquis

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WHO Recommends Against Hydroxychloroquine To Prevent Covid-19, Oklahoma Is Stuck With Piles Of It

 

Remember hydroxychloroquine, the drug that some were pushing as a possible way to prevent Covid-19? Well, the World Health Organization (WHO) is now saying fugget about it.

The BMJ has published a “living WHO guideline on drugs to prevent covid-19,” and on it is the statement, “We recommend against administering hydroxychloroquine to prevent Covid-19.” This is based on a review of available evidence, mainly six randomized controlled trials involving over 6,000 participants, by the WHO Guideline Development Group (GDG) panel of international experts. There was no meaningful difference in rates of Covid-19 infection diagnoses, hospitalizations, and death between people who had taken hydroxychloroquine and those who had not. At the same time, taking hydroxychloroquine brought the risk of adverse effects like heart rhythm problems, blood and lymph system disorders, kidney injuries, and liver problems from the medication typically used against malaria. It’s called a “living” guideline because the WHO plans on adding recommendations about other drugs being considered to prevent Covid-19.

That means people and states like Oklahoma that purchased hydroxychloroquine after then-U.S. President and now Mara-A-Lago resident Donald Trump touted the medication are now stuck with stockpiles of this stuff. That is unless the U.S. is overrun by malaria-carrying mosquitoes anytime soon. And take a wild guess as to who ultimately has had to pay for these stockpiles that may go unused and expire? If you live in a state like Oklahoma, go to the bathroom, look in the mirror, and point at yourself. Yes, that’s right, taxpayers had to pay for the stuff.

That’s why the Oklahoma attorney general’s office is apparently attempting to negotiate a return of 1.2 million hydroxychloroquine pills that the state purchased in April last year from FFF Enterprises for around $2 million, according to Sean Murphy reporting for the AP. Jimmy Kimmel recently parodied their situation with an Oklahoma “travel” commercial:

 

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Yeah, trying to get a refund of around $2 million is not exactly as easy as getting your money back for the fake butt underwear that you bought online. The supplier can always say, “umm, but you bought it, and we can’t re-sell it. Because no one freaking wants that much hydroxychloroquine now.”

Governor Kevin Stitt (R) reportedly defended the purchase last year by saying, “I was being proactive to try and protect Oklahomans.” Protect Oklahomans? Based on what evidence? At no point were real public health experts in the U.S. saying “stockpile hydroxychloroquine.”

Proactive wasn’t exactly the theme of an article written on January 18, 2021, by Carmen Forman for The Oklahoman entitled, “As coronavirus surges in Oklahoma, Gov. Kevin Stitt mum on next steps.” In the article, Forman mentioned that “Oklahoma has been the worst state for test positivity and ranked fourth-highest for new Covid-19 cases per capita.” She also wrote that “asked what, if any, new steps Stitt is considering to reduce the spread of COVID-19 in Oklahoma, his office did not give specifics and leaned on the governor’s oft-used mantra of ‘personal responsibility.’” Well, looks like Oklahoma state residents have been personally responsible for paying for all those doses of unused hydroxychloroquine.

One of the biggest tragedies of 2020 and 2021 has been political leaders not heeding the advice of real scientific and public health experts. While public health experts in the U.S. were pushing for similar policies and interventions that successfully controlled the spread of the virus in countries like South Korea, Taiwan, and New Zealand, political leaders like Trump and others didn’t seem to be listening. It appeared, instead, that they were listening to the voices pushing for the use of hydroxychloroquine. Some of these voices may have actually been people trying to sell hydroxychloroquine. After all, when do you get a chance to sell to taxpayers over one million doses of an anti-malarial medication in the U.S.?

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