WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.
Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards with an outside advisory committee of experts — perhaps as soon as this week — that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.
The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.
That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.
The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.
“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.
The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.
A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for about two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.
The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.
That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.
Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”
F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.
The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public,” and White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.
Staff members at the budget office then scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.
The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.
The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.
Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.
Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”
“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”
Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.
At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”
Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.
The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.
Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.
In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.
The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.
Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.
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.
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.
Good Is the New Cool When It Comes to a Successful Brand
October 27, 2020 5 min read
Opinions expressed by Entrepreneur contributors are their own.
Afdhel Aziz is a thought leader, writer, speaker, consultant and board advisor with 20 years of experience working as a visionary marketer at companies like Procter & Gamble, Nokia, Heineken and Absolut Vodka. Despite creating world-class pop culture partnerships with everyone from Lady Gaga to the TED Conferences, he felt there was more he could be contributing to society.
This search inspired him to co-write Good is the New Cool: Market Like You A Give a Damn. The book’s success led Aziz to quit his job and follow his own purpose. Now he is on a mission to help companies and individuals find purpose and meaning in their work and in their lives.
An internationally acclaimed keynote speaker, Aziz is also the co-founder and Chief Purpose Officer of Conspiracy of Love. The purpose consultancy supports a long roster of clients, including iconic brands like Adidas, Red Bull, Oreo and Microsoft, to Fortune 500 companies like Unilever, AB Inbev, Mondelez and Diageo.
“Goodisthenewcool.org is now a global movement of good, with events and podcasts in association with Soho House, conferences in LA, Sydney and Melbourne, and an online community of 20,000 purpose-driven leaders in business and culture,” Aziz says.
Aziz spoke with Jessica Abo to discuss Conspiracy of Love, why businesses should take the “good is the new cool” approach and why it’s not too late for companies to do better.
Jessica Abo: Tell us about your book Good is the New Cool: Market Like You A Give a Damn.
Afdhel Aziz: It’s an exploration of the whole world of purpose driven marketing. Today, brands more than ever are asked to take stands. When you think about Nike with Colin Kaepernick, for example, consumers are asking brands to take positions in social issues. We wanted to explore that in this book that I co-wrote with Bobby Jones. The expectation for brands to help solve societal problems has never been more sky high.
In the wake of Covid-19 and Black Lives Matter, consumers are demanding that the brands in their lives stand up for their values. Consumers are voting with their wallets, we like to say, and making sure that if they’re going to invest in a brand‘s products and services, that brand better be helping solve issues, whether they’re environmental issues or social issues. There is an incredibly high level of scrutiny at the moment that brands are under and expectations keep growing as well.
What are some of the biggest mistakes brands make?
Aziz: One of the biggest mistakes brands make when they venture into this territory of social impact is positioning themselves as the hero, riding in on a white horse to solve the problem. We like to preach to our clients the maxim “be the helper not the hero.” Brands who do this find a way to make the consumers the hero of the journey to give them platforms to help society at large. And this way you can avoid the trap of coming across as too egotistical when talking about how you’re going to attack this problem.
Do brands have to be perfect to start doing good?
Aziz: Brands do not have to be perfect to do some good. In fact, I would say that no brand is perfect, just like no human being is perfect. It’s important not to be paralyzed by the lack of perfection. Every brand has its problem, has its issues. As long as they’re transparent about it and say, “Listen, here’s the plan that we’re putting into place to solve this problem, bear with us while we do it. But in the meantime, here’s another problem that we really want to solve in society, will you help us?” Taking that humble posture really helps people understand the genuineness of your intentions and that really makes a difference when asking people to participate.
What advice do you have for brands that want to do some good in the world?
Aziz: The advice that we have for brands who want to do some good in the world is, first of all, listen. Listen to your employees, listen to your consumers, look at the culture in the world today and try and find a way of thinking of people as citizens, not just consumers. Think about the broad range of issues that they care about, and then figure out a way that you, as a brand can get involved in helping to solve some of those problems as well. We like to say brands should solve problems from the everyday to the epic. It doesn’t all have to be about climate change and racial inequality. Maybe there are everyday problems as well that you as a brand can get involved in to make people’s lives a little bit better.
What Counts as Race Discrimination? A Suit Against JPMorgan Is a Test
Over 18 years of working as a secretary at JPMorgan Chase, Wanda Wilson had learned to brush aside remarks directed at her race.
“Wanda, do you mind if I tell a Black joke?” a colleague once asked her. Another co-worker told her that she disliked Black people in general but made an exception for Ms. Wilson.
Ms. Wilson saw no reason to complain. JPMorgan had been a good employer, giving her opportunities to rise through the secretarial ranks and providing assistance during a fraught time in her personal life. She felt proud defending her career to her family, which included several prominent civil rights activists. (Her mother is the poet Amina Baraka, and her stepfather was Amiri Baraka, the playwright and poet. Her younger brother is Ras Baraka, the mayor of Newark.)
But things soured in 2016 after a new colleague began to bully Ms. Wilson and order her around, according to a lawsuit Ms. Wilson filed against JPMorgan and its chief executive, Jamie Dimon. For the first time, Ms. Wilson felt that she was not on equal footing with her white colleagues, according to the suit. She complained to JPMorgan officials, but the bank’s response shattered her faith in her employer, she said. After she was unable to find a different job within JPMorgan, the bank fired her. She then sued, alleging race discrimination and retaliation and seeking an unspecified amount in damages.
JPMorgan said its officials had done everything in their power to make things right for Ms. Wilson. “The firm denies that it engaged in any race discrimination or harassment or retaliation with respect to Ms. Wilson’s employment,” said Joe Evangelisti, a JPMorgan spokesman.
The bank tried to have the lawsuit, filed in 2018, dismissed. This month, a judge ruled that the two sides should engage in mediation instead.
Wall Street has come under growing scrutiny for how it treats people of color, and Black employees in particular. Last year, The New York Times detailed allegations of racism at Phoenix-area branches of JPMorgan. Recently, a former head of global diversity at Morgan Stanley, a Black woman, sued the bank for discrimination.
But while such cases claim broad and systemic discrimination involving banks, Ms. Wilson’s lawsuit tells the complicated story of interactions between co-workers that can carry racist undertones. It shows how allegations of racism in a workplace can be difficult to verify, even when a company conducts an investigation. That’s especially so in the absence of explicit language or actions — such as a racial slur or blackface — that are easily identifiable as racist.
“This isn’t the ’60s or the ’50s,” said David Carlor, a financial adviser who is Black. “No one’s going to tell you: ‘Because you’re Black, go get us coffee.’ You’re just going to find that you’re the one that’s being treated most disrespectfully in the office.”
At JPMorgan, Ms. Wilson was often the first to arrive and the last to leave, according to three of her former colleagues, who spoke on the condition of anonymity. She got lunch and coffee for her superiors and ran errands that seemed well outside her job description, like buying a mirror for her boss’s office.
In March 2016, Ms. Wilson joined the audit department as an executive administrative assistant — a coveted position among secretaries because it involved handling duties for one senior executive in that department.
Around the same time, Janet Jarnagin was also assigned to Ms. Wilson’s boss as a team leader. A midlevel executive, Ms. Jarnagin’s duties included helping the audit department prepare presentations and reports, according to a publicly available résumé.
Over the next few months, Ms. Jarnagin began ordering Ms. Wilson to hang coats, get coffee and lunch, or carry out requests — such as making photocopies — by visitors to the department, according to the lawsuit.
Once, Ms. Jarnagin stood up from her desk and announced that she was “sending Wanda out for coffee,” asking if anyone else wanted to place an order with her. Other Black secretaries who had overheard Ms. Jarnagin later teased Ms. Wilson about being treated like Kizzy, an enslaved character in the book and television mini-series “Roots.”
Ms. Wilson said that she asked Ms. Jarnagin not to use the term “sending” any more, but that Ms. Jarnagin ignored her. Ms. Wilson described the incident in a 2017 interview with a JPMorgan official, a recording of which she provided to The Times.
In her lawsuit, Ms. Wilson described how Ms. Jarnagin had been making these demands only of her — the lone Black secretary in the vicinity. She tried to distance herself. When she rearranged her desk so that the two women no longer had an unobstructed view of each other, Ms. Jarnagin mocked her for trying to build a “Mexican wall” out of a stack of folders on her desk, according to the lawsuit.
Ms. Wilson complained about Ms. Jarnagin to their boss, who told her to work things out on her own, according to the complaint. She then told a human resources representative that Ms. Jarnagin was ordering her around and bad-mouthing her work. JPMorgan’s Mr. Evangelisti said the bank had begun investigating Ms. Wilson’s complaints immediately.
Henry Klingeman, a lawyer for Ms. Jarnagin, dismissed the allegations. “In the high-intensity, high-stress world of New York banking, Janet was no more rude than a male employee who is assertive,” he said in an email. “That she asked an administrative assistant to get coffee for senior management is one of the criticisms made against her. There is nothing to this, much less implied racism.”
Ms. Wilson eventually emailed Mr. Dimon: “I have followed the chain of command and have not received any assistance.” Mr. Dimon did not personally respond, but her complaint was promptly shared with senior bank officials who stepped up their investigation.
Bank officials interviewed people in the immediate vicinity of Ms. Wilson and Ms. Jarnagin, two people familiar with the investigation said. The investigators determined that Ms. Jarnagin had behaved rudely toward Ms. Wilson. However, since Ms. Jarnagin had been rude in the past to other employees who were not Black, they concluded that her behavior was not racially motivated, the people said.
Mr. Evangelisti said the officials’ conclusions had been “based on information provided by Ms. Wilson at the time.”
Ms. Jarnagin was given two “coaching” sessions, including one by her boss, the people said. She was never formally disciplined, but was advised to treat Ms. Wilson more gently, they said. Ms. Jarnagin left JPMorgan in November 2017.
JPMorgan officials also did a broader “climate study” of the area where Ms. Wilson worked, the people familiar with the matter said. The study concluded that there did not appear to be a problem with racism.
However, two Black employees interviewed for the study, who did not want to be identified for fear of retaliation, told The Times that race was a constant undertone in their interactions with non-Black employees. One said Black secretaries felt it was harder for them to get promotions, and they believed they were underpaid. But the Black employees said they downplayed the racism they witnessed to bank officials, partly because it wasn’t directed at them.
JPMorgan officials have recently acknowledged that some employees still do not feel safe speaking up. In March, the bank announced that it had reviewed its anti-discrimination practices and identified several areas for improvement.
Things didn’t improve for Ms. Wilson after her complaint.
Mr. Evangelisti said JPMorgan gave her nearly a year to search for a new job inside the bank as well as a raise and bonus during that time. Ms. Wilson said the only job the bank offered her was a role working for a man who had become enraged at her over a disagreement with her boss when she worked in the audit department.
Mr. Evangelisti said the role would have come with the same title, grade and compensation as her prior job, “but Ms. Wilson declined the role and refused to provide any context about an ‘unpleasant exchange’ she claims to have had.”
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