The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading →

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]

by Adriana Gallardo, ProPublica, and Ariel Goodman for ProPublica

They’ve gotten to know New York City in a way many have not, through the low-wage work of cleaning its skyscrapers, serving its restaurants and crisscrossing its streets on bicycles, through long subway rides very early in the morning and very late at night. The saying goes: You’re not a true New Yorker unless you’ve lived here for a decade. They’ve done their time and felt a deep sense of belonging in this city of immigrants.

But, in the epicenter of a pandemic, the undocumented have never felt more alone.

They are losing loved ones but do not qualify for city funding to help bury them. They are getting sick but hesitating to get tested or go to the hospital, balancing their fear of the virus with their fear of exposure to immigration authorities. They are worried about supporting their families abroad as well as those who live with them, weighing whether to keep working perilous jobs or to stay home and somehow keep food on the table.

They’ve experienced separation, but not like this — out in the world, in a skeleton crew, wearing a mask to deliver food to closed doors; in cramped apartments, sectioned off, in an attempt to quarantine. They are divided across national borders as family members die, praying novenas on Google Hangouts. Their bodies cannot be buried, intact, where they were born; they move from hospital bed, to refrigerated truck, to incinerator.

ProPublica interviewed two dozen undocumented Latino immigrants and their families about their experiences with death, illness and survival. Some spoke on the condition of anonymity, afraid of being targeted. Others allowed us to use their first names or the full names of their family members who died.

One kitchen worker from the Bronx worked in the World Trade Center two decades ago. “We used to fill the back elevators of those towers,” he said. He lost friends on Sept. 11, 2001, who were not identified or acknowledged among the dead because their names did not match those on record or their families were unable to claim the bodies.

He and others spoke to ProPublica because this time they wanted their experiences to be counted as part of the story of their city, overtaken by a virus.

Barriers to a Proper Burial

Adrian Hernandez Lopez, 38, never planned to stay in New York City. His 15 year stint here was dotted with visits to his family in Mexico, for the baptism of his son, who is now almost a teen, and to check on the house he had been sending his paychecks to build.

He and brother worked at an Italian restaurant in Times Square. “We were always together,” his brother said. They crossed the border together and, years later, commuted together from Queens to midtown Manhattan.

The last time they spoke by phone, Lopez waited in agony in a hard chair at Elmhurst Hospital, breathing in oxygen from a machine. He was transferred to Woodhull Hospital in Brooklyn. One day later, the father of two wound up in a vegetative state.

He died on April 2. His mother, who lives in Allende, a small village in the state of Puebla, wants him buried there, alongside two babies she lost just after birth.

He can’t be traditionally buried, despite the strong Mexican custom. More than 400 Mexican migrants are known to have died of COVID-19 in the New York area, but for health reasons, Mexico will only accept their bodies if they are cremated.

In place of seeing the body one last time, Lopez’s brother was sent photos by the funeral home, which will hold the cremains while the family figures out how to get them to Mexico.

The Mexican Consulate pledged financial aid to the families of nationals who died of COVID-19 complications, but it has been slow to materialize. According to Lopez’s brother, they’ve been asked to follow guidelines to receive a reimbursement. The Consulate General’s office in New York said it was not authorized by the Mexican government to give interviews at the time of our request for comment.

The city of New York provides burial assistance, but it requires a Social Security number for both the deceased and the person requesting funds. City officials say they are limited by federal and state law in the help they can offer. “We are exploring every possible option to ensure that all New Yorkers, regardless of immigration status, are able to bury their loved ones in the way they feel is most fitting,” city spokesperson Avery Cohen said.

Two members of the City Council have called for an emergency fund to provide assistance to all low-income families, including the undocumented.

“One of the most devastating calls I’m regularly getting is from people who can’t afford to bury their loved ones and aren’t eligible for any assistance,” Council Member Francisco Moya said in a release. “That’s simply not acceptable.”

Lopez’s family is one of several raising money for the transport and burial of their loved one who died in the United States.

As he tries to figure out how to send Lopez home, his brother sits in the small apartment they shared in Queens, with his wife and 6-year-old daughter, listening to the sirens that have become a constant reminder of their loss. He and his wife have been out of work for a month. They don’t know how they will pay the rent.

Deterred From Seeking Care

More than a dozen undocumented people told ProPublica that when they got sick, they stayed home, deterred from seeking care by the worry that they would not get it if they tried. They faced the same obstacles as everyone else in New York, where hospitals were crowded and unsafe, and feared additional ones involving their immigration status.

Fani lives in East Harlem. Over the last 18 years, she’s worked at a laundromat and a factory, a restaurant and as a babysitter. When she and her husband got sick they called 311. She said the voice on the other end confirmed their COVID-19 symptoms and told them to stay home unless they couldn’t breathe.

“They said there were no beds, no respirators. We healed each other as best we could with soups, teas and Tylenol,” she said.

Sonia, who became ill with COVID-19 symptoms almost three weeks ago, was afraid to go to the hospital. “I knew several people who went into the hospital with symptoms and they never came back,” she said. “That was my fear and why I decided to not go in. I preferred to isolate myself at home, with a lot of home remedies and hot teas.”

Multiple people said they knew hospitals had limited resources and worried they would be placed last in line for care because they were undocumented. “They’re going to let us die,” one man told his brother. A woman named Yogi in the Bronx said, “It might not be that they don’t want to treat us, maybe there weren’t enough supplies.”

Stories rippled through the Latino community about those who had difficulty getting care and those who could not be saved. According to a recent poll of voters in New York City, more than half of Latinos there said they know someone who died, the highest percentage of any group asked.

They hear stories about people like Juan Leonardo Torres, a 65-year-old retired doorman who knew someone on every corner of Corona, Queens. Unlike the others, Torres, from the Dominican Republic, was a citizen. Even so, he grew discouraged when he tried to get care.

Within one week at the end of March, Torres had gone from feeling slightly ill to experiencing difficulty breathing and fevers that his wife Mindy tried to manage using herbs and other “remedios caseros,” or home remedies. She and her five sons who lived with them finally persuaded him to go to Long Island Jewish Medical Center Forest Hills, just a five-minute drive from the house.

When Torres arrived, he told his family there were not enough seats in the crowded emergency room. He gave his chair up to an older woman and stood for hours as staff connected and disconnected him to an oxygen tank.

Fifteen hours later, on a drizzly night, Torres appeared at the door of the family home. It was 2:30 a.m. He had made the walk alone and declared in Spanish, “For no reason do I want to go to the hospital to die like a dog.”

He spent the next three days quarantined in his son’s room, where he died.

As the family waited six hours for his body to be retrieved, his wife sat in the living room “like a statue.”

Calculating Survival

Unable to qualify for relief programs like unemployment and stimulus cash, undocumented people are faced with the difficult choice of working dangerous jobs or running out of the money they need for essentials like food and housing.

“The little we have goes to food,” said Berenice, who suffers from kidney problems and whose son struggles with asthma. She’s been home for weeks along with her husband Luis, who before the pandemic worked at a cab company.

“Yes, we need money, but there is also our health,” Berenice said. “We have family who are sick and friends who died. We are trying to survive.”

Luis has lived in New York for 18 years, working his way up from delivering pizza on a bicycle to owning a cab. He worries about exposing his wife and son. “I just want this to pass and we’ll see about starting over again,” he said.

Adan lives in the Bronx with his two teenage sons, who were born in New York City, and his wife. She cleaned homes. He worked in a restaurant in East Harlem. Neither are working and both overcame COVID-19. “The little money we had went to pay last month’s rent,” he said. “I don’t know what to do, we just want to work.”

He said his landlord always comes looking for the rent in person. He told “el señor” that he’s spending all his money on food. The man gave him flyers about unemployment, but Adan knows he won’t qualify. “Me las voy a ver duras,” he said. He’s going to see hard times. He said he has lived in the same building for 11 years and has never missed a payment. Even though he can’t be evicted now, he said, “the debt will be there.”

Adding to the pressure, for some, is that they also work to support family members in their home countries, who count on the money they send.

One delivery worker in Queens sends $400 to Mexico every two weeks to help his son, who studies biomedicine at a university in Puebla; that helps him cover what he needs for school, including rent and transportation. He sends another $300 each month to his elderly mother.

He said he remains one of only a few bicycle delivery workers at his diner who are still on the job, and he is seeing more orders than usual. He’s always worked six days a week, but this past month was so busy, he couldn’t stop to eat lunch or take breaks.

He would much rather be outside than at home, but the streets feel tense. “I feel strange not seeing anyone or saying hi anymore, but I think it’s much better this way,” he said. “I understand why people are afraid.”

Even though he doesn’t see them in the buildings he visits, customers have been conscious about leaving tips in envelopes. He feels grateful as he passes the long lines in Queens of those waiting for free food. It makes him sad to know how many need it now.

He rents a room in an apartment he shares with three other men who have all lost their jobs. One was in construction, the other two in restaurants. He takes precautions to keep them safe when he comes home, including changing his clothes before coming in. “It would be irresponsible not to,” he said.

He hopes the rules of social distancing, and his mask and gloves, will protect him. “I’m not scared,” he said. “If you are afraid all the time, you will get sick faster.”

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by Yeganeh Torbati

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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by Peter Elkind, ProPublica, and Meg Cramer, WNYC, with Doris Burke, ProPublica

On May 12, after a six-week delay caused by the pandemic, the U.S. Supreme Court will hear arguments in the epic battle by congressional committees and New York prosecutors to pry loose eight years of President Donald Trump’s tax returns.

Much about the case is without precedent. Oral arguments will be publicly broadcast on live audio. The nine justices and opposing lawyers will debate the issues remotely, from their offices and homes. And the central question is extraordinary: Is the president of the United States immune from congressional — and even criminal — investigation?

Next week’s arguments concern whether Trump’s accounting firm, Mazars USA, must hand over his tax returns and other records to a House committee and the Manhattan district attorney, which have separately subpoenaed them. (There will also be arguments on congressional subpoenas to two of Trump’s banks.) Trump, who promised while running for president to make his tax returns public, has sued to block the documents’ release. The questions apply beyond this case. Trump has repeatedly resisted congressional scrutiny, most recently by vowing to ignore oversight requirements included in the trillion-dollar pandemic-bailout legislation. “I’ll be the oversight,” he declared.

The president’s accounting firm has found itself at the center of this high-stakes fight. The American arm of a global firm, Mazars has portrayed itself as an innocent bystander in the war between Trump and his pursuers, dragged into the conflict merely for possessing the trove of subpoenaed records. It’s the firm’s first burst into the media glare apart from an unfortunate moment of tabloid coverage in 2016 after one of its New York partners stabbed his wife to death in the shower of their suburban home. (He pleaded guilty to manslaughter.) Mazars has said it will abide by whatever decision the court makes in the Trump matter.

But Trump’s accountants are far from bystanders in the matters under scrutiny — or in the rise of Trump. Over a span of decades, they have played two critical, but discordant, roles for Trump. One is common for an accounting firm: to help him pay the smallest amount of taxes possible. The second is not common at all: to help him appear to the world to be rich beyond imagining. That sometimes requires creating precisely the opposite impression of what’s in his tax filings.

Time and again, from press interviews in the 1980s to the launch of his 2016 campaign, Trump has trotted out evermore outsized claims of his wealth, frequently brandishing papers prepared by members of his accounting team, who have sometimes been called on to appear in person when they were presented, offering a sort of mute testimony in support of the findings. The accountants’ written disclaimers — that the calculations rely on Trump’s own numbers, rendering them essentially meaningless — are rarely mentioned.

Trump’s accountants have been crucial enablers in his remarkable rise. And like their marquee client, they have a surprisingly colorful and tangled story of their own. It’s dramatically at odds with the image Trump has presented of his accountants as “one of the most highly respected” big firms, solemnly confirming his numbers after months of careful scrutiny. For starters, it’s only technically true to say Trump’s accounting work is handled by a large firm.

In fact, Trump entrusts his taxes and planning to a tiny, secretive team of CPAs who have operated at various times from humble quarters in Queens and two Long Island office parks. That team, which has had two leaders with back-to-back multidecade terms, has been working for the Trumps since Fred Trump began using the firm back in the 1950s. It was eventually subsumed into Mazars USA, the American arm of a large international firm, through a series of mergers over decades.

Listen to the Episode

One theme has been consistent: partners and sometimes the firm itself have faced accusations of fraud, misconduct and malpractice on multiple occasions, an investigation by ProPublica and WNYC has found.

That pattern dates to the 30 years during which the Trump accounting team was led by Jack Mitnick, whose pugnaciousness was exceeded only by his aversion to his clients paying the IRS. He was the architect of the notorious schemes, revealed by The New York Times, to dodge more than $500 million in gift and inheritance taxes and funnel hundreds of millions from Fred Trump to his children, helping keep Donald Trump afloat through four of his business bankruptcies. Mitnick was known as an accounting star — at least until 1996, when his partners threw him out of the firm amid accusations of fraud and malpractice.

Years of turmoil followed. The firm operated without malpractice insurance for a period and was dogged by feuds — with current and former partners suing each other — and financial problems.

And it ran afoul of regulators. In January of 2004 — one week after “The Apprentice” premiered on NBC — the Securities and Exchange Commission formally censured the firm for willfully aiding and abetting misconduct. The SEC suspended one partner from practicing before it for four years for what the agency called “highly unreasonable” and “improper professional conduct.”

Since Trump’s accountants merged their practice into Mazars in 2010, they have been present for Trump’s scandals, too. Mazars accountants prepared the tax returns for the Donald J. Trump Foundation, forced to shut down and ordered to pay more than $2 million in damages after a New York attorney general’s investigation exposed a history of illegal self-dealing. And the Manhattan DA’s office, which is investigating whether the Trump Organization falsified its business records to cover up hush-money payments to adult film actress Stormy Daniels, subpoenaed not only Trump’s tax returns but also various internal records and assessments prepared by Mazars.

Today, the CEO of Mazars USA is the same partner who was suspended by the SEC for four years for improper conduct. (Mazars defends its CEO, saying he meets all ethical and professional standards, and asserts that the firm has encountered no more sanctions or litigation than other comparable firms.)

The choice of a formerly suspended accountant as CEO surprised former SEC Chief Accountant Lynn Turner, now a senior adviser at the Hemming Morse financial consulting firm. “In my opinion,” said Turner, “that speaks loudly with the respect to the confidence one would have in that firm — better yet, the total lack of confidence one would have in that firm. And it would certainly make me wonder about the culture of that firm and whether or not that firm acts with integrity.”

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Whether by design, or perhaps just coincidence, Trump’s accountants have occasionally displayed the sort of audacity often associated with their client. Consider this example involving New York City taxes back in the 1980s. Mitnick claimed that Trump was exempt from paying tax on profit he made by flipping a Trump Tower condo. He had acquired the unit at cost, $634,648, ostensibly for providing “consulting services” to his development partnership, then sold it 19 days later for $3 million.

At an administrative court hearing, Mitnick defended deductions that he’d claimed offset any profits from Trump’s consulting business, even as he failed to provide any documentation or explanation for those expenses, according to the 15-page court opinion in the case. He went so far as to deny that he’d prepared the federal tax return for Trump that also claimed the deductions, even though his signature was on the document.

The accountant evidently protested vociferously in the New York case, leading the administrative law judge to scoff, “The problem at issue is not one of double taxation, but of no taxation.” The total amount at stake was relatively modest — $87,693.57, including penalties and interest — but Mitnick, on Trump’s behalf, contested it for more than a decade before a city appeals panel finally put an end to the case, ordering Trump to pay up.

Decades after he left the Trump account, Mitnick briefly surfaced in the press in 2016, after the Times reported that Trump’s 1995 tax return reported a $916 million loss. Mitnick, then 80, dismissed Trump’s boast that he was a tax genius for using the loss to avoid paying taxes for as much as a decade. “I did all the tax preparation,” the dour accountant told TV interviewers. “He never saw the product until it was presented to him for signature.” Mitnick added, with apparent pride: “Those returns were entirely created by us.”

When ProPublica first sought to speak with Mitnick late last year, he asked, “What’s in it for me?” and said he’d discuss Trump only if he were paid for his time. (In a longer second call, where he also asked to be paid, he eventually offered brief responses to some questions.)

An accountant and attorney, Mitnick first arrived at Spahr Lacher & Berk, the tiny firm later merged into Mazars, in 1963, at age 27. Mitnick soon took charge of the Trumps’ accounts. He would oversee them for the next 30 years.

In its early years, Spahr was located in Jamaica, Queens, and employed just a handful of CPAs. The firm had been working with the Trump family, whose five-bedroom Tudor home was in tonier Jamaica Estates, at least since 1951, when Fred Trump cemented the relationship by hiring a Spahr partner as controller for his growing real estate business.

Fred Trump was far and away Spahr’s biggest client. His cash-spewing rental apartment empire in Brooklyn and Queens required lots of accounting work, and Fred paid his bills in full and on time. By 1979, Spahr Lacher had moved into a nondescript suburban office park in Lake Success, Long Island, just beyond the Queens border and the reach of New York City taxes.

By then Donald Trump had begun pursuing his big, risky and expensive ambitions: glitzy towers and hotels in Manhattan; three over-the-top Atlantic City casinos; his own airline; a massive yacht and a professional football team. In 1987, as his father had done, Donald hired his company’s controller from the ranks of his accounting firm.

Trump’s accountants played a critical role in Donald’s survival through the 1980s and early ʼ90s, a period when many of his projects crashed and burned, requiring massive infusions of cash from his father. With Mitnick in charge, Spahr hatched the strategies that minimized both gift and estate taxes on the transfer of Fred’s wealth to Donald and his siblings.

A 2018 Times investigation found that Fred Trump had funneled at least $413 million in current dollars to his son and that the Trumps’ tax-avoidance tactics, all told, had slashed their tax bill by about $500 million. The article described some of the tax moves as “outright fraud.” (Trump’s lawyer called that conclusion “100% false” and said the relevant authorities “fully approved all of the tax filings.”)

A lynchpin of the strategy was the 1992 creation of a corporation, All County Building Supply & Maintenance, through which Fred Trump’s children charged their father’s business grossly inflated prices, then split the markup, allowing them to avoid gift taxes even as they reeled in millions from their father.

The strategy was viewed as a major success inside the accounting firm. “I wish I could take credit for it,” Mitchell Zachary, a former Spahr partner who worked on the Trumps’ accounts for more than a decade, told ProPublica and WNYC. “It was brilliant, but it wasn’t mine,” Zachary said. “It was a team of accountants, partners at Spahr.” Zachary defended the firm’s practices for the Trumps as “aggressive” but “within the letter of the law.”

Mitnick was viewed as “a tax god” inside the firm, said Zachary, who worked at Spahr Lacher from 1986 to 2002 and teamed with Mitnick on the Trumps’ accounts. The family “wouldn’t make a move” without checking with Mitnick, he said. Mitnick even made a cameo appearance (albeit with his name misspelled) in the first chapter of Trump’s 1987 book, “The Art of the Deal.”

Mitnick pressed for every advantage on Trump’s behalf, ever urging Zachary to be bolder. A fundamental Mitnick principle: “If you can’t find me where the law says you can’t do it, you can do it.” Said Zachary: “He always took these very aggressive positions and would never back down. Never. He always felt, ‘I’ll just keep appealing.’”

Mitnick’s team developed virtually all the Trumps’ tax-avoidance maneuvers, Zachary said. “I mean, it was all for their benefit in so many ways,” he said. “It’s not like they were going to question it.”

Donald Trump’s accounting work was much more complex than that of his father. His business operated scores of separate entities, each requiring its own tax filings. Just preparing his annual personal return took three to four months.

Diving into Trump’s personal finances, as Zachary did in the late 1980s, proved bewildering. Warned that his work for Trump was sure to face an audit, Zachary said he took special care to trace every asset, expense and receipt. When he finally finished, he was mystified. Zachary couldn’t find evidence that Trump, in fact, possessed any cash beyond a recent payment in a casino deal.

“I went to Jack Mitnick, and I said, ‘Look, I must be missing something: There’s nothing here!’… I thought for sure I screwed up. I thought for sure I missed something big.”

Zachary recalled Mitnick’s reply. “He just laughed and went: ‘Well, you just figured it out!’”

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Spahr took unusual steps to safeguard the confidentiality of Donald Trump’s returns. No work papers or documents could be left on a CPA’s desk overnight; everything had to be carefully locked up.

The secrecy was imposed to hide the chasm between Trump’s public claims and reality, according to Zachary: “He bragged a lot. … More than any other individual that I’ve ever seen, he was very big at promoting that he’s this super-rich billionaire.”

Trump was a difficult client. He demanded discounts on fees and took forever to pay his bills. “Collecting from Trump was awful,” Zachary said. Eventually Spahr agreed to give Trump a 50% discount and allow him 12 months to pay. Zachary said: “Donald always made it clear: ‘You get the privilege of saying you’re Donald Trump’s accountants, so you have to pay the price.’”

Trump’s nearly $1 billion write-off for 1995 represented an aggregation of the enormous losses his business blunders had run up — and Spahr skillfully exploited them on Trump’s behalf. Trump paid no federal income tax in nine of the 11 years from 1984 through 1994, according to tax materials obtained by the Times and publicly released documents.

It is true that the Trumps’ aggressive tactics drew virtually nonstop scrutiny from tax authorities. Indeed, they spent so much time examining the Trumps’ books, Zachary said, that Spahr Lacher had a special room permanently set aside for the IRS’s Trump auditors. (Zachary also cites this scrutiny, and the relatively modest resulting adjustments, as evidence that Spahr’s tactics didn’t cross the line.)

Spahr’s focus on wealth-transfer strategies intensified in the early 1990s, after Fred Trump, a detail-minded workaholic, began suffering from poor health and dementia. One tactic was to divide legal ownership of Fred’s properties into separate family partnerships, so Fred lacked complete control. That helped justify lowball appraisals for tax purposes. “There was an appraiser out there that the IRS hated … because he was so aggressive. And that’s the guy we used,” Zachary said. That appraiser, he said, reduced the claimed values of Fred Trump’s properties by 35% to 40% — and occasionally dramatically more.

By the time Fred Trump died in 1999, Mitnick was gone from the firm. His departure followed a series of troubling lawsuits and other setbacks relating to work for non-Trump clients. In one case brought over Mitnick’s administration of a tax-shelter investment involving coal mine leases, a federal appeals court wrote in 1985: “The record amply demonstrates that he committed fraud.”

In a second case, longtime Spahr clients charged Mitnick and the firm with “a long-term coverup of Mitnick’s malpractice” on their family’s estate and audit work, accusing them of missing filing deadlines and making false statements to the IRS, which they claimed cost the family millions in taxes and penalties. They asserted that Mitnick and his team neglected them and “devoted most of their professional time to other clients, including Donald Trump and his enterprises.” After the trial judge found that Mitnick was “the primary wrongdoer,” the matter was eventually settled for about $500,000, according to Mitnick’s deposition testimony in yet another malpractice suit against both him and the firm.

Mitnick, meanwhile, had his own problems with the IRS. He had filed three federal tax court cases between 1987 and 1990 challenging IRS levies against him and his wife on their personal taxes.

He became an enigma to his Spahr partners. Mitnick often seemed oblivious to important deadlines. One partner recalls finding Mitnick, just hours before a critical tax filing was due, in the firm’s staff room with a hammer and screwdriver, fixing a broken chair.

By the mid-1990s, the litigation had left Spahr Lacher unable to obtain insurance, threatening the firm’s continued existence. Partners, including Zachary, shifted their assets into their spouses’ names. Records show the Mitnicks’ home, located 2 miles from the firm’s office, was held in his wife’s name.

In September 1996, the partners expelled Mitnick. They told clients that Mitnick, then 60, was retiring. Less than a year later, he became a tax counsel with a Long Island law firm, where he remained until 2014.

Asked about these events, Mitnick, now 84, repeatedly declined to comment, saying he couldn’t discuss “confidential communications between myself and the client.” He added, “You’re going back to the dark ages.”

Mitnick eventually fell on hard times. In 2007, after Citibank filed a foreclosure action on an unpaid $500,000 mortgage loan, Mitnick and his wife sold their $1.4 million Long Island home. Three years later the IRS slapped him with a lien for more than $155,000 in unpaid federal tax debts dating back to 2003. Mitnick and his wife relocated to a modest house in Palm Beach County, Florida.

In May 2017 Mitnick and his wife were evicted after failing to pay $11,331 in assessments and penalties to their homeowners association. Their possessions were placed out on the street. Less than two years later, in March 2019, they were ejected again, this time evicted from an apartment for unpaid rent and, according to a court filing, “physically removed from the premises.”

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At the time Mitnick left the firm, partners feared his departure might cost them the Trump business, which Zachary estimates represented about a third of the firm’s total billings. But Trump agreed to stick with Spahr.

Still, the firm’s existence was precarious. Unable to obtain malpractice coverage, Spahr’s eight partners, after being hit by another lawsuit settlement, learned they would have to dig into their own pockets to pay it.

So they happily welcomed an acquirer: M.R. Weiser & Co., a midsize Manhattan accounting firm eager to establish a big presence on Long Island. Spahr’s leaders signed off on the deal only after again seeking Trump’s personal blessing. He gave it, Zachary said, after being assured his fees wouldn’t increase.

As it turned out, Weiser had problems of its own. The firm had engaged in a disastrous buying binge aimed at transforming the firm into a regional powerhouse. The deals instead triggered what partners later described as a “crisis of finances and morale.” Just a year after swallowing Spahr, Weiser’s partners ousted the firm’s chairman, Stanley Nasberg, who then sued, demanding $5 million in damages and sending the dispute to an arbitration panel. (In an interview, Nasberg maintained he was “instrumental” in the rapid growth of the firm and recruitment of major clients. He blamed his ouster on the “greed” of his then-partners.)

The 24-page report from the arbitration panel detailed a litany of “recriminations and factual and legal disputes.” The firm had suffered such “acute cash shortages” that some senior partners had delayed depositing their year-end paychecks in 1999; partner draws had been withheld altogether in early 2000.

For years Weiser was roiled by factional conflicts, cash-flow problems and bitter litigation. “It became just a disjointed mess,” said Jeff Coopersmith, a partner who arrived in 1999 as the result of one merger and was frog-marched out six years later after the firm discovered his plans to start his own firm with two other partners (and take clients with him).

Amid all this turmoil, the Trump group remained a constant. With Mitnick’s departure, the firm handed its leadership to a CPA who seemed even more single-mindedly dedicated to the mogul: Donald Bender.

Bespectacled, bald and bookish, Bender had arrived at Spahr in 1981, shortly after earning his accounting degree at Queens College. He’s been there ever since. (Through a firm spokesman, Bender declined requests for an interview.)

Bender had a monkish devotion to his work, and to Trump, who became his sole client. Bender remained single well into middle age, when he married a woman who’d worked at Weiser. Now 62, he still runs the Trump account and lives with his family in a drab townhouse, six minutes’ drive from his office.

Bender’s dedication won Trump’s respect, said Zachary, who worked closely with Bender until leaving the firm in 2002. “He really devoted his life to Donald Trump,” Zachary said, enough to earn him an invitation to Trump’s wedding to Melania Knauss at Mar-a-Lago in 2005.

Operating from offices at one end of the accounting firm’s floor, Bender and his small Trump team kept to themselves. It had long been standard practice to maintain extraordinary security provisions for all of Trump’s electronic files, including barring anyone from viewing them without a special password.

Bender’s group had a mystique within the firm. In a 2017 essay published on a literary website, a former junior accountant at Weiser, Henry Kogan, recounted meeting Bender — whom he referred to as “the other Donald” — in the firm’s cafeteria. “After I introduced myself and the small talk subsided he said, ‘Everything you say will be repeated.’… In my two years at Weiser LLP, I learned the other Donald didn’t talk much but when he did it was worth listening to.”

Kogan described the knowledge of Trump’s financial world as “passed down from one generation to the next through a single, chosen accountant, orally.” As he put it, “You could sense the weight of this knowledge in the way [Bender] walked, the way he carried himself, carefully and with precision. Sometimes it seemed as if he were moving across a tightrope, invisible across the thickly carpeted office floor.” Bender’s “entire professional existence,” he wrote, “revolved around one client, that client’s organization, and the hundreds of entities represented inside an IRS form.”

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As Trump banked evermore on his image for breathtaking wealth, he enlisted his accountants to back his dubious claims. For example, struggling to avoid personal bankruptcy in 1994, Trump cooperated with a cover story in Vanity Fair promoting his “comeback.”

“Piece by piece, deal by deal, a beautiful story is starting to emerge about me,” Trump declared, after picking up writer Edward Klein in his stretch limo. As they were driven to a black-tie dinner at the Waldorf-Astoria hotel honoring Trump as “Humanitarian of the Year,” Klein wrote, “he handed me a folder containing his personal financial statement, which had been prepared by the accounting firm of Spahr, Lacher & Sperber.” It showed $139,326,000 in cash and equivalents.” That figure seemed unlikely given that four of Trump’s companies had gone bankrupt during the early 1990s.

Similar documents surfaced in 2006, after Trump was stung by a book written by Tim O’Brien that ridiculed his boasts of being worth as much as $6 billion. The book, “TrumpNation: The Art of Being the Donald,” cited three confidential sources “with direct knowledge of Donald’s finances” who said the number was actually between $150 million and $250 million.

Looking to rehabilitate the image of his net worth — on Forbes’ annual list of billionaires — Trump enlisted his accountants. He summoned two Forbes reporters, according to one of them, Stephane Fitch. They arrived at his Trump Tower conference room to find a table piled with leather-bound volumes and stacks of manila folders, supposedly documenting how much Trump was worth. Also present, to help make the case: Bender and his Weiser partner Gerald Rosenblum. The two accountants sat silently as Trump and his deputies touted his wealth. Forbes ultimately pegged it at $2.9 billion — about half of what Trump claimed — but far higher than O’Brien’s assessment.

Trump sued O’Brien for defamation, and in the litigation, too, the accountants and their work played a supporting role. A 25-page document, on Weiser letterhead, titled “Accountants Compilation Report” was produced during discovery. (“I do keep one actually on my desk, hidden,” Trump testified during the case.) A two-page disclaimer explained that the report (which claimed a net worth of $3.5 billion) was based entirely on “the representation of the individual whose financial statements are presented.” In other words, all the numbers came from Trump.

Trump made clear just how unreliable that was, at one point testifying during his deposition: “My net worth fluctuates, and it goes up and down with markets and with attitudes and with feelings, even my own feelings.” Asked if he’d ever exaggerated in statements about his properties, Trump replied: “I think everyone does.”

The disclaimer on the “compilation” noted that Weiser had done nothing to confirm the unaudited numbers, which included wholesale departures from generally accepted accounting principles (GAAP). In particular, the statement acknowledged counting future income streams that were in doubt; excluding much of Trump’s debt; failing to reflect whether Trump actually owned only a portion of the assets he listed; and ignoring both repayment obligations and whatever taxes he owed.

Weiser did sometimes prepare GAAP-compliant audited financial statements for Trump, when required by some lenders and regulators. These statements revealed a lower net worth. So Trump shared the “compilation” documents with reporters instead.

O’Brien’s lawyers deposed the two Weiser partners who worked on the Trump document. Asked to explain a memo he’d written calling Trump’s valuations on properties “subjective,” Bender demurred: “I don’t have the professional expertise to discuss valuations.” Rosenblum, who said he had been preparing such statements for Trump since the early 1980s, was more direct. “In the compilation process, it is not the role of the accountant to assess the values,” he testified. “The role is to accept those values and move them forward.” He acknowledged he made no attempt to corroborate any of the figures. (A judge granted O’Brien a summary judgment, later upheld by an appeals court, in Trump’s libel suit.)

Trump continued to offer selective financial statements. If anything, the list of recipients seemed to grow, to include banks and insurance companies, according to congressional testimony last year by former Trump lawyer Michael Cohen, shortly before he went to prison. Cohen released copies of Trump’s financial statements for 2011, 2012 and 2013 and testified: “It was my experience that Mr. Trump inflated his total assets when it served his purposes, such as trying to be listed among the wealthiest people in Forbes, and deflated his assets to reduce his real estate taxes.”

By this point, Mazars had become his accountants of record (the Weiser merger occurred in 2010) and the disclaimers in the financial statements had grown to exclude anything involving the finances of Trump’s large hotels in Las Vegas and Chicago. The 2011 and 2012 statements placed Trump’s net worth at $4,261,590,000 and $4,558,680,000, respectively.

They included multiple false claims. As The Washington Post reported last year, the 2011 statement claimed Trump Tower was 68 stories tall (it’s 58); exaggerated the size of Trump’s Virginia vineyard (it’s 1,200 acres, not 2,000); inflated the number of lots approved for sale at his golf course in southern California (it was 31, not 55); and claimed a 212-acre Westchester County estate he’d bought in 1996 for $7.5 million was already “zoned for 9 luxurious homes” and thus worth $291 million. Local officials said the property was really worth about $20 million, and the project, which faced years of opposition from area residents, was never built. Trump took a tax write-off on the property instead. These false statements alone appear to have inflated Trump’s claimed wealth by hundreds of millions.

Once again, when Trump announced his campaign for the presidency in gala fashion in 2015, he waved a financial statement that he said his accountants had prepared. This time the tally was $8,737,540,000.

“To pay an auditor to say ‘we have not checked the numbers, and the numbers don’t follow any rules’ — you just don’t see that,” said George Washington University assistant accountancy professor Kyle Welch. “This is not a real financial statement. This is a promotional document.” Welch said the sweeping disclaimer protects the accountants from legal liability or industry sanctions.

He doubts a larger firm would have been willing to affix its name to such statements. “I don’t think any of the Big Four would put their name on those financial statements,” Welch said. “I don’t think they could have been paid enough to get it done.”

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Not long after it acquired Trump’s accounting firm, Weiser came under investigation by the SEC. The matter was resolved in 2004, with an agreed settlement order: Two Weiser CPAs were suspended from practicing before the commission for “highly unreasonable” and “improper professional conduct.” The SEC also censured Weiser, ordering it to disgorge $39,679 and hire an outside consultant to review its policies and compliance procedures.

According to the SEC, Weiser had failed to properly monitor its client, a financial advisory firm called Sagam Capital Management, that was already operating under a cease-and-desist order for securities fraud and thus, as Weiser knew, warranted “heightened scrutiny.” These failures, the SEC found, had “willfully aided and abetted” more misconduct. (Sagam’s CEO later went to prison for stealing millions from his customers.)

Victor Wahba, the Weiser partner in charge of the assignment, was barred from SEC practice for a minimum of four years. (He didn’t admit or deny wrongdoing.) But Wahba remained at the firm, and was promoted, just one year later, to run its New York office. In 2012, 15 months after being reinstated by the SEC, Wahba was named co-CEO of Mazars. He became chairman and CEO of Mazars USA in 2015.

Wahba declined requests for an interview, but Mazars provided a statement that read, in part: “Under Victor Wahba’s leadership, Mazars USA has become a national leader in tax, accounting and consulting. He is well recognized as a thoughtful and charitable CEO.” It noted that Wahba now “remains in good standing” with various industry and government regulators, including the SEC.

Trump’s accounting firm faced other issues. In 2009, a partner received a three-year SEC suspension for secretly negotiating for a high-level job with a client he was then auditing. The SEC called the partner’s conduct “at a minimum, reckless.” He eventually left the firm.

In separate, more recent cases, the U.S. attorney’s office in Manhattan prosecuted two other CPAs who worked at the firm for their involvement in illegal tax shelters.

Ronald Katz, a partner at Weiser for five years starting in 2004, received a nine-month prison sentence in 2017 after pleading guilty to conspiring with a New York tax attorney in what federal prosecutors described as a “corrupt multi-year tax evasion scheme.” Katz had been indicted, among other offenses, on charges of failing to pay taxes on $1.2 million in fee income while at the firm. Internal firm financial documents show that for 2004, Katz billed $6.6 million in fees, far more than any other partner in the firm. Katz declined to comment.

In August 2019, New York federal prosecutors settled a civil complaint against former Mazars senior manager Michael Schwartz. In legal filings, prosecutors said he had arranged for more than 100 taxpayers to claim “large phony tax losses,” cheating the government out of hundreds of millions of dollars in taxes. (The shelters dated back to 2002, but were already under court challenge by the government when Mazars hired Schwartz in 2008.) In 2010, a federal appeals court found that one of Schwartz’s transactions, which allowed a tech executive to shelter $60 million in stock gains with an investment of less than $1 million, was “specifically designed to create a massive tax loss devoid of economic reality.”

Despite this, Schwartz remained at the accounting firm until 2015, just weeks before the IRS assessed him for $35.4 million for promoting unregistered fraudulent tax shelters. After filing for bankruptcy, Schwartz settled the IRS claim by agreeing to pay $650,000. (“This had nothing to do with WeiserMazar,” Schwartz said. “This was all activities done way before I joined the firm. They knew about it. But they hired me for my international tax expertise.”)

In its statement, Mazars dismissed the notion that it had a troubling record. “Any suggestion that Mazars USA is an industry outlier with regard to its business practices or litigation history is false and misleading. Even a cursory review of the history of any large accounting firm or business will reveal the inevitability of litigation. Our history is no different than any other similarly situated firm.”

Mazars declined to respond to a long list of questions regarding its work for the Trumps, citing the need to protect client confidentiality. Its statement noted, “Mazars USA prides itself on providing professional accounting, audit and consulting services in accordance with all professional and ethical standards, rules, and regulations.”

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Because it handles virtually all the tax and accounting needs for Donald Trump, Mazars has inevitably found itself immersed in more recent controversies surrounding its famous client.

This extends to the Donald J. Trump Foundation, whose annual tax returns Bender has regularly prepared and signed. For 2016 and 2017, before the foundation’s dissolution, Mazars also audited its financial statements, filed with the New York attorney general’s office. Among these documents, there is no indication the firm did anything to spotlight or curtail the financial abuses that eventually forced the charity’s shutdown.

The Mazars accountants were complicit in the foundation’s illegal practices, according to Marcus Owens, an attorney and expert in nonprofit law who ran the IRS’ exempt-organizations division for a decade. “I cannot fathom how they would not know,” he said. Owens called the firm’s role in the foundation’s misconduct “extraordinary. ... I’ve been practicing charity law for 45 years, including 25 at the IRS, and I’ve never seen anything like it.” Added Owens: “This is aiding and abetting someone doing something that is in clear violation of federal tax law. It really calls into question what’s going on with every other tax return that firm prepared.”

Mazars’ role, if any, in the Stormy Daniels hush money scandal remains unclear. As ProPublica has reported, the Manhattan DA’s office is investigating whether the Trump Organization’s payments, falsely reimbursed to Michael Cohen as a “legal retainer,” represented an illegal falsification of the company’s books and records. It is not evident what Mazars, in preparing its tax filings and auditing its books, knew — or should have known — about this.

But it is clear that the investigation by Manhattan DA Cyrus Vance extends far beyond the scope of that 2016 episode. Vance’s grand jury subpoena seeks tax returns, work papers, financial statements and communications dating back to 2011. If the Supreme Court affirms two federal lower court rulings that he should get them, Vance’s investigators will be free to look for evidence of other potential crimes.

For all the anticipation about the documents being sought by both the criminal prosecutors and Congress, it is possible that the public may never see them even if the Supreme Court orders Mazars to turn over the records.

In Vance’s investigation, requirements for grand jury secrecy will prevail unless the documents lead to criminal prosecutions. It’s also not clear whether the congressional committees would make public any Trump records.

The greatest revelations also may not be contained in the tax returns themselves, which will lack detail about Trump and his businesses, but in the thousands of pages of other materials that Congress and the DA have also subpoenaed. These include the hundreds of corporate returns, also prepared by Mazars, detailing Trump’s investments, his debts, his sources of income and his partners. Equally important, the accountants’ work papers and communications with the Trump Organization could reveal unguarded internal assessments and exchanges about his finances.

The Supreme Court fight may end with a whimper. On April 27, the court hinted that it may be looking for a way to punt at least part of the three cases involving Trump’s tax records: It asked the parties to submit supplemental briefs to answer effectively whether the court should even be trying to resolve the two cases in which Congress has subpoenaed the records. (This would not affect the third case, involving the Manhattan DA). The question, as Scotusblog characterized it, is “whether courts should stay out of the fight over the subpoenas because it is fundamentally a political dispute between the branches of government. If the justices were to conclude that the doctrine applies, they could dismiss the cases without ruling on the merits of the dispute — which might be a particularly appealing outcome for some justices in the lead-up to the presidential election.”

Such a decision would clear the way for Mazars and Trump’s banks to comply with the congressional subpoenas if they chose to do so — but would provide no judicial means of enforcement, according to University of Texas law professor Stephen Vladeck, a Supreme Court expert. (Asked about such a Supreme Court outcome, a Mazars spokesman said the firm stands by its previous statement that it will “respect the legal process and fully comply with its legal obligations.”) That would provide for a much less stirring conclusion than, say, a unanimous high-court opinion declaring that the president is not above the law.

But the court could still affirm the third case, in which federal courts ordered Mazars to turn over the returns to the Manhattan DA. If Mazars then complies with that subpoena, that will leave the firm in good graces with the court — but likely facing the wrath of its client of many decades, the president of the United States.

by Justin Elliott, Paul Kiel and Lydia DePillis

Through programs like the Small Business Administration’s Paycheck Protection Program and the Federal Reserve’s Main Street Lending Program, the federal government is deploying hundreds of billions of dollars in grants, loans and bond purchases to help businesses amid the coronavirus-sparked economic crisis. Each program comes with different strings, but their basic purpose is to keep workers on the payroll.

We want to know what this means for your workplace. How has your company treated its workers during the crisis? Have you or your colleagues been laid off, furloughed or otherwise affected? Have you seen money used in surprising ways? What do you think we should be reporting on?

We are the only ones reading what you submit. If you would prefer to use an encrypted app, here is what we suggest. Send questions to bailout@propublica.org.

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by J. David McSwane

The Transportation Security Administration ignored guidance from the Department of Homeland Security and internal pushback from two agency officials when it stockpiled more than 1.3 million N95 respirator masks instead of donating them to hospitals, internal records and interviews show.

Internal concerns were raised in early April, when COVID-19 cases were growing by the thousands and hospitals in some parts of the country were overrun and desperate for supplies. The agency held on to the cache of life-saving masks even as the number of people coming through U.S. airports dropped by 95% and the TSA instructed many employees to stay home to avoid being infected. Meanwhile, other federal agencies, including the Department of Veterans Affairs’ vast network of hospitals, scrounged for the personal protective equipment that doctors and nurses are dying without.

“We don’t need them. People who are in an infectious environment need them. Nobody is flying,” Charles Kielkopf, a TSA attorney based in Columbus, Ohio, told ProPublica. “You don’t take things for yourself. It’s the wrong thing to do.”

Kielkopf shared a copy of an official whistleblower complaint he filed Monday. In it, he alleges the agency had engaged in gross mismanagement that represented a “substantial and specific danger to public health.”

TSA has not required its screeners to wear N95s, which require fitting and training to use properly, and internal memos show most are using surgical masks, which are more widely available but are less effective and lack the same filtering ability.

Kielkopf raised a red flag last month about the TSA’s plan to store N95 respirators it had been given by Customs and Border Protection, which found more than a million old but usable masks in an Indiana warehouse. Both agencies are overseen by DHS. That shipment added to 116,000 N95s the TSA had left over from the swine flu pandemic of 2009, a TSA memo shows. While both stockpiles were older than the manufacturer’s recommended shelf life, the Centers for Disease Control and Prevention said that expired masks remain effective against spreading the virus.

Kielkopf and another TSA official in Minnesota suggested that the agency send its N95 masks to hospitals in early April, records show. Instead, TSA quietly stored many of them in its warehouse near the Dallas-Fort Worth airport and dispersed the rest to empty airports across the nation.

“We need to reserve medical masks for health care workers,” Kielkopf said, “not TSA workers who are behind an X-ray machine.”

The Number of Travelers Passing TSA Checkpoints Has Dropped to Historic Lows

The TSA didn’t provide answers to several detailed questions sent by ProPublica, but spokesman Mark Howell said in an email that the agency’s “highest priority is to ensure the health, safety and security of our workforce and the American people.”

“With the support of CBP and DHS, in April, TSA was able to ensure a sufficient supply of N95 masks would be available for any officer who chose to wear one and completed the requisite training,” the statement read.

“We are continuing to acquire additional personal protective equipment for our employees to ensure both their and the traveling public’s health and safety based on our current staffing needs, and as supplies become available,” TSA said.

A review of federal contracting data shows the agency has mostly made modest purchases such as a $231,000 purchase for gallons of disinfectant, but has not reported any new purchases of N95s.

An internal TSA memo last month said the surplus of N95s was expected to last the agency about 30 days, but the same memo noted that estimate did not account for the drastic decline in security officers working at airports. ProPublica asked how long the masks were actually going to last, accounting for the decreased staffing levels.

“While we cannot provide details on staffing, passenger throughput and corresponding operations have certainly decreased,” the TSA statement said.

The trade journal Government Executive reported this week that internal TSA records showed most employee schedules have been “sharply abbreviated,” while an additional 8,000 security screeners are on paid leave over concerns that they could be exposed to the virus.

More than 500 TSA employees have tested positive for COVID-19, the agency reported, and five have died.

The CDC has not recommended the use of N95s by TSA staff, records show, but that doesn’t mean workers who have or want to wear them can’t.

In one April 7 email, DHS Deputy Under Secretary for Management Randolph D. Alles sent guidance to TSA officials, urging them to wear homemade cloth face coverings and maintain social distancing. But the N95s, which block 95% of particles that can transmit the virus, were in notoriously short supply and should be “reserved” for health care workers.

“The CDC has given us very good information about how to make masks that are suitable, so that we can continue to reserve medical masks and PPE for healthcare workers battling the COVID-19 pandemic,” Alles wrote.

But two days later, on April 9, Cliff Van Leuven, TSA’s federal security director in Minnesota, followed up and asked why he had been sent thousands of masks despite that guidance.

“I just received 9,000 N-95 masks that I have very little to no need for,” he said in the email, which was first reported by Government Executive. “We’ve made N95s available to our staff and, of the officers who wear masks, they overwhelmingly prefer the surgical masks we just received after a couple months on back order.”

Minnesota Gov. Tim Walz had publicly asked that anyone who had PPE donate their surplus to the state’s Department of Health, Van Leuven said in the email to senior TSA staff.

“I’d like to donate the bulk of our current stock of N-95s in support of that need and keep a small supply on hand,” he wrote, adding the Minneapolis-St. Paul International Airport had screened fewer than 1,500 people the previous day, about a third of which were airport staff.

Van Leuven declined to comment, referring questions to a TSA spokesperson.

Later that day, Kielkopf forwarded the concerns to TSA attorneys in other field offices, trying to get some attention to the stockpile he felt would be better used at hospitals.

“I am sharing with you some issues we are having with n95 masks in Minnesota,” he wrote. “And the tension between our increasing supply of n95 masks at our TSA airport locations and the dire need for them in the medical community.”

Weeks went by, and finally, on May 1, Kielkopf wrote: “I have been very disappointed in our position to keep tens of thousands of n95 masks while healthcare workers who have a medical requirement for the masks — because of their contact with infected people — still go without.”

DHS did not respond to ProPublica’s questions about why it transferred N95 masks to TSA despite a top official saying they should be reserved for healthcare workers.

“So now the TSA position is that we desperately need these masks for the protection of our people,” Kielkopf said. “At the same time, most of our people aren’t even working. It’s a complete 180 that doesn’t make any sense.”

Do you have access to information about federal contracts that should be public? Email david.mcswane@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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by Marshall Allen

The links to the viral video “Plandemic” started showing up in my Facebook feed Wednesday. “Very interesting,” one of my friends wrote about it. I saw several subsequent posts about it, and then my brother texted me, “Got a sec?”

My brother is a pastor in Colorado and had someone he respects urge him to watch “Plandemic,” a 26-minute video that promises to reveal the “hidden agenda” behind the COVID-19 pandemic. I called him and he shared his concern: People seem to be taking the conspiracy theories presented in “Plandemic” seriously. He wondered if I could write something up that he could pass along to them, to help people distinguish between sound reporting and conspiracy thinking or propaganda.

So I watched “Plandemic.” I did not find it credible, as I will explain below. YouTube, Facebook and Vimeo have since removed it from their platforms for violating their guidelines. Now it’s available on its own site.

Sensational videos, memes, rants and more about COVID-19 are likely to keep coming. With society polarized and deep distrust of the media, the government and other institutions, such content is a way for bad actors to sow discord, mostly via social media. We saw it with Russia in the 2016 election and we should expect it to continue.

But what surprised me is how easily “Plandemic” sank its hooks into some of my friends. My brother also felt alarmed that his own church members and leaders in other churches might be tempted to buy into it.

The purpose of this column is not to skewer “Plandemic.” My goal is to offer some criteria for sifting through all the content we see every day, so we can tell the difference between fair reporting and something so biased it should not be taken seriously.

Here’s a checklist, some of which I shared with my friends on Facebook, to help interrogate any content — and that includes what we publish at ProPublica.

Is the Presentation One-Sided?

There’s never just one side to a story. I mentioned this point in 2018 when I wrote about my faith and the biblical basis for investigative reporting. One of my favorite Proverbs says, “The first to state his case seems right until another comes and cross-examines him.” So a fair presentation should at least acknowledge opposing points of view.

I didn’t see this in “Plandemic,” so I called the filmmaker, Mikki Willis, who is also the film’s narrator, to ask him whether I had somehow missed the other side of the argument. I had not. “The other side of the argument plays 24/7 on every screen in every airport and on every phone and in every home,” Willis said. “The people are only seeing one side of the story all the time. This is the other side of the story. This is not a piece that’s intended to be perfectly balanced.”

I asked Willis if it was fair to call his film “propaganda,” which the Oxford dictionary defines as “information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.”

He said he doesn’t feel there’s anything misleading in his film, but otherwise the definition fits. And based on that definition he feels 100% of news reporting is propaganda. “What isn’t propaganda these days?” he asked. “In that sense, what we’re doing is fighting fire with fire.”

Is There an Independent Pursuit of the Truth?

The star of “Plandemic,” medical researcher Judy Mikovits, is controversial. The magazine Science reports that it published and then retracted one of her papers in 2011. A search warrant provided to ProPublica by one of her former attorneys shows she was fired from her position at Whittemore Peterson Institute, a research center in Nevada, in September 2011. Then she allegedly stole notebooks and a laptop computer from the Institute, the search warrant said, leading to an arrest warrant for alleged possession of stolen property and unlawful taking of computer data. She was arrested on Nov. 18, 2011, but denied wrongdoing. The charges were dropped.

But “Plandemic” ignores or brushes past these facts and portrays her as an embattled whistleblower. “So you made a discovery that conflicted with the agreed-upon narrative?” Willis says to Mikovits, introducing her as a victim. “And for that, they did everything in their powers to destroy your life.”

A typical viewer is not going to know the details about Mikovits’ background. But as the primary source of controversial information being presented as fact, it’s worth an online search. The fact-checking site PolitiFact details her arrest and criminal charges. Clearly, there’s more to her story than what’s presented in “Plandemic.” That should give us pause when we assess its credibility.

Is There a Careful Adherence to the Facts?

In “Plandemic,” Willis asks Mikovits about her arrest: “What did they charge you with?”

“Nothing,” she replies. “I was held in jail, with no charges.”

Being charged with a crime is one of those concrete facts that we can check out. Science magazine reported Mikovits’ arrest and felony charge. I also found a civil lawsuit she filed against the Whittemore Peterson Institute in 2014 in the U.S. District Court for the Southern District of California. “Mikovits was arrested on criminal charges…” her complaint says in the case, which was eventually dismissed.

I asked Willis about the apparent discrepancy, where she said in his film that she wasn’t charged, when court documents show that she was charged. After my inquiry, he said he spoke to Mikovits and now feels it is clear that she meant that the charges were dropped.

I tracked down Mikovits and she said what she meant in the film is that there were no charges of any type of wrongdoing that would have led to her being charged with being a fugitive from justice. She admitted that all the controversy has been hard for her to sort out. “I’ve been confused for a decade,” she told me. She said she would try to be more clear in the future when she talks about the criminal charge: “I’ll try to learn to say it differently,” she said.

This underscores the importance of careful verification, and it distinguishes the craft of journalism from other forms of information sharing. People often speak imprecisely when they’re telling their stories. It’s our duty to nail down precisely what they do and do not mean, and verify it independently. If we don’t, we risk undermining their credibility and ours. That’s in part why we at ProPublica and many other journalists often link directly to our underlying source documents, so you can verify the information yourself.

Are Those Accused Allowed to Respond?

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is one of the nation’s leaders in the response to the coronavirus. In “Plandemic,” Mikovits accuses Fauci of a cover-up and of paying off people who perpetrate fraud, among other things. PolitiFact found no evidence to support the allegations against Fauci.

Every time I write a story that accuses someone of wrongdoing I call them and urge them to explain the situation from their perspective. This is standard in mainstream journalism. Sometimes I’ve gone to extreme lengths to get comments from someone who will be portrayed unfavorably in my story — traveling to another state and showing up at their office and their home and leaving a note if they are not there to meet me. “Plandemic” doesn’t indicate whether the filmmakers reached out to Fauci for his version of the story. So I asked Willis about it. “We did not,” he told me.

Are All Sources Named and Cited, and if Not, Is the Reason Explained?

All sources should be identified, with their credentials, so viewers can verify their expertise or possible biases. If they can’t be for some reason, then that should be explained. “Plandemic” features unnamed people in medical scrubs, presented as doctors, saying they’re being wrongly pressured to add COVID-19 on people’s death certificates or are not being allowed to use the drug hydroxychloroquine to treat patients. But the speakers are not named, so we can’t really tell who they are, or even if they are doctors at all. That makes it impossible to tell if they are credible.

I asked Willis why he didn’t name those people. He told me he was in a hurry to release the 26-minute version of “Plandemic,” but the doctors will be named in the final version. “We should have done that,” he said.

Does the Work Claim Some Secret Knowledge?

“Plandemic” calls itself a documentary that reveals “the hidden agenda behind COVID-19.” We are in the midst of a global pandemic where few people in the world can figure out what is happening or the right way to respond, let alone agendas. We have almost every journalist in the country writing about this. And if the truth about a conspiracy is out there, many people have an incentive to share it. But “Plandemic” would like us to think it’s presenting some exclusive bit of secret knowledge that is going to get at the real story. That’s not likely.

Plus, to be honest, there were so many conspiratorial details stacked on top of each other in the film I couldn’t keep them straight. When I spoke to Willis I told him I was having a hard time understanding his point. Then I took a stab at what I thought was the main thrust of his argument. “Are you saying that powerful people planned the pandemic and made it happen so they could get rich by making everyone get vaccines?” I asked.

It turns out Willis isn’t sure either. “We’re in the exploratory phase,” he told me. “I don’t know, to be clear, if it’s an intentional or naturally occurring situation. I have no idea.”

Then he went on to say that the pandemic is being politicized and used to take away our civil liberties and leverage other political policies. “Certain forces” have latched onto the situation, he said. “It’s too fishy.”

He had me at, “I have no idea.” That sums it up. This is a vast pandemic and massive catastrophe. Our country wasn’t prepared for it, and the response by our top leaders has been disjointed. We’re restricted to our homes. Many people have lost their jobs and some are afraid or sick or dying. That makes us vulnerable to exploitation by people who will present inaccurate or intellectually dishonest information that promises to tell us the truth.

Perhaps “Plandemic” is guilty of sloppy storytelling, or maybe people really do believe the things they’re saying in the video. Or perhaps they’re being intentionally dishonest, or it’s a biased connecting of the dots rooted in personal and professional grievances. I don’t know because I can’t get inside their heads to judge their motives.

Ultimately, we’re all going to need to be more savvy consumers when it comes to information, no matter how slickly it’s presented. This may be but a signal of what’s to come in the run-up to the 2020 presidential election, when memes and ads of unknown origin come across our social media feeds. There are standards for judging the credibility of the media we take in every day, so let’s apply them.

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It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

Pharmacy staff who are thought to have died as a result of the COVID-19 pandemic are to be among the healthcare workers remembered with a minute’s silence on 28 April 2020.

To read the whole article click on the headline

Pharmacists will not be automatically eligible for a new government life assurance scheme for healthcare workers in England who die from COVID-19 during the pandemic.

To read the whole article click on the headline

Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced.

To read the whole article click on the headline

Just over 550 community pharmacy staff members were referred for COVID-19 tests through a national booking system run by the Care Quality Commission, over ten days in mid-April 2020, the NHS watchdog has told The Pharmaceutical Journal.

To read the whole article click on the headline

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]

April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […]

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

The successful activation of T cells is critical to the immune system's ability to clear infections. A retrospective study in China found that COVID-19 patients had remarkably low T-cell counts in their blood, while some pro-inflammatory cytokines such as IL-6—which Roche’s Actemra targets—were elevated.

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.

Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.

While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money.

From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more.

With social distancing in full effect, families have not only found themselves with a lot more time together, but a lot more time in front of their screens.

The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues.

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.

The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer.

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."

And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool?

A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.

Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing.

View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off.

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.

Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases.

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.

Beverly Hills-based William Morris Endeavor said it is reducing its workforce by 20% through furloughs, layoffs and moving people to part-time employees.