US PPE supply chains failed, and COVID-19 deaths followed

U.S.-WASHINGTON, D.C.-COVID-19-DEATHS-REMEMBRANCE

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FILE - Twenty thousand empty chairs were set up near the White House on Sunday to mourn the more than 200,000 lives lost in United States from COVID-19. (Xinhua/Liu Jie via Getty Images)

Nurse Sandra Oldfield’s patient didn’t have the usual symptoms of COVID-19 — yet. But then he tested positive for the virus, and it was clear that Oldfield — a veteran, 53-year-old caregiver — had been exposed.

She was sent home by Kaiser Permanente officials with instructions to keep careful notes on her condition. And she did.

“Temperature 97.1,” she wrote on March 26, her first log entry. Normal.

She and her colleagues said they had felt unsafe at work and had raised concerns with their managers. They needed N95 masks, powerful protection against contracting COVID-19. Kaiser Permanente had none for Oldfield. Instead, she was issued a less effective surgical mask, leaving her vulnerable to the deadly virus.

Many others were similarly vulnerable, and not just at this 169-bed hospital in Fresno. From the very moment the pandemic reached America’s shores, the country was unprepared. Hospitals, nursing homes and other health care facilities didn’t have the masks and equipment needed to protect their workers. Some got sick and spread the virus. Some died.

The Associated Press and “FRONTLINE” launched a seven-month investigation -- filing Freedom of Information Act requests, testing medical masks, interviewing dozens of experts from hard-hit hospitals to the White House -- to understand what was behind these critical shortages.

Medical supply chains that span oceans and continents are the fragile lifelines between raw materials and manufacturers overseas, and health care workers on COVID-19 front lines in the U.S. As link after link broke, the system fell apart.

This catastrophic collapse was one of the country’s most consequential failures to control the virus. And it wasn’t unexpected: For decades, politicians and corporate officials ignored warnings about the risks associated with America’s overdependence on foreign manufacturing, and a lack of adequate preparation at home, the AP and “FRONTLINE” found.

As the pandemic rolled into the U.S., Asian factories shut down, halting exports of medical supplies. Meanwhile, government stockpiles were depleted from a flu outbreak a decade earlier, and there was no way to rapidly restock. The federal government dangerously advised people not to wear masks, looking to preserve the supply for health care workers. Counterfeits flooded the market.

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The nursing homes that most often reported PPE shortages were for-profit, part of a chain, and had COVID-19 cases among residents and staff, according to the Associated Press.

Now, with more than 210,000 Americans dead and the president himself infected with the virus, the U.S. grieves the consequences. And nurses are still being told to reuse masks designed to be thrown away after each patient.

At home with her aged dog Freckles at her side, Sandra Oldfield recognized the symptoms as she recorded them in her log over 11 days:

“Chills”

“Weakness”

“Dizziness”

She lost her appetite. Her handwriting grew shaky. Someone called an ambulance. Others came for her pets.

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Although it will take years for researchers to understand why the pandemic was disproportionately worse in the U.S., early studies that compare different countries’ responses are finding that shortages of masks, gloves, gowns, shields, testing kits and other medical supplies indeed cost lives.

The lack of early testing was a major stumble. First, the U.S. Centers for Disease Control and Prevention’s tests were faulty. Then there weren’t enough. The Food and Drug Administration raced to approve more tests, but without access to cheap, disposable swabs -- made almost entirely in Italy and now in very short supply -- they were useless. U.S. public health departments' worst fears were quickly realized.

Chrissie Juliano, executive director of the Big Cities Health Coalition, a forum of the largest public health departments, said the lack of available information about the actual burden of the virus “set our country’s response back by an order of magnitude we will never know.”

Meanwhile, studies in nursing homes -- in China, Washington state and across the U.S. -- found that COVID-19 cases were significantly higher in places with shortages of personal protective equipment, or PPE. Harvard Medical School professor Dr. Andrew T. Chan and colleagues found health care workers who didn’t have adequate PPE had a 30% greater chance of infection than colleagues with enough supplies. Black, Hispanic and Asian staffers had the highest risk of catching COVID-19, they found.

A University of California, Berkeley study estimated that at least 35% of health care and other essential workers in California who tested positive for COVID-19 were infected at work, amid shortages.

“And these are unacceptable deaths, each of which could have been prevented if we had had adequate supply chains in place in advance of the pandemic,” said UC Berkeley Professor William Dow.

Dow and his colleagues say there would be massive savings, in lives and tax dollars, if the government invested more in buying and storing stockpiles of supplies.

“This is a case where no individual health care organization is large enough to move the market and induce suppliers to invest in those types of supply chains,” said Dow. “So the government needs to be able to go in and guarantee a certain amount of purchases so that it will be in the self-interest of each one of these manufacturers to be willing to put in the investments into that supply chain.”

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In 2005, newly appointed secretary of the Department of Health and Human Services Mike Leavitt began ringing pandemic alarm bells after a disturbing briefing from the CDC about a potentially lethal virus.

“Their concern was that it would begin to mutate in a way that would allow it to go from animal to person and then person to person. And once it achieved that capacity, it was a pandemic virus,” said Leavitt.

He went to the White House and told President George W. Bush, who rolled out at $7.1 billion pandemic preparedness plan. Leavitt, a Republican, spent the next three years traveling to all 50 states, warning health officials to get ready by stockpiling six to eight weeks of masks, gloves and other supplies.

If America’s supply chains were crippled or compromised, he cautioned, it would exacerbate the devastation of a pandemic.

In meetings, panels, even commencement addresses, Leavitt advised public officials to come up with back up plans. But they didn’t.

“Over time, when the snake is not at your ankle, you’re worried about other things that are dangerous. And this is not just a function of our generation. This has been the case in virtually every pandemic in human history,” said Leavitt.

The AP and “FRONTLINE” spoke with members of the Clinton, Bush, Obama and Trump administrations who were responsible for pandemic preparedness. All said they had worried and warned about inadequate supply chains. But solutions were expensive, and neither Congress nor the White House made this a priority.

“We learned during Ebola that speed matters. Outbreaks grow exponentially. You pay a tremendous penalty for inaction,” said Christopher Kirchhoff, an Obama advisor who wrote the National Security Council's “lessons learned study” for the White House after the 2014-16 outbreak.

Among his 26 specific findings: The U.S. government needed to buy and stock protective equipment during an emergency, in the event that traditional supply chains failed.

During the Obama-Trump transition period, a group of newly appointed Trump aides gathered for an exercise in disaster preparedness hosted by top members of the Obama administration, including Nicole Lurie, a medical doctor who’d served as assistant secretary for preparedness and response. They discussed the supply chain, and the importance of securing necessary PPE in case of a pandemic.

“There was not a lot of traction on the part of most of the people participating,” Lurie said. “One didn’t have the sense coming in that this was going to be high on the priority list.”

In 2019, the Trump administration conducted an exercise dubbed “Crimson Contagion,” a pandemic flu simulation exercise involving 12 federal agencies, 74 local health departments and 87 hospitals across 12 states.

Their key takeaways foreshadowed exactly what would happen less than a year later: In a pandemic, the U.S. would not have enough “on-hand stock of antiviral medications, needles, syringes, N95 respirators, ventilators, and other ancillary medical supplies.” Countries that make those supplies were going to keep them for their own citizens. And there wasn’t enough domestic manufacturing to fill that gap.

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As the U.S. outbreak started, Lurie said she repeatedly reached out to Trump administration officials to raise concerns and offer help, but was rebuffed.

“So many thousands of people have died needlessly, and it didn’t need to be this way,” she said. “But I think if I reflect on what’s going on here, this is an administration that had policies, procedures, tools, plans, checklists, advance warning, all of those things, and it appears to have used almost none of it.”

The Trump administration has blamed China, and its entry into the World Trade Organization in 2001, for the country’s dominance over America’s medical supplies. But the lure of cheap labor and lower production costs started drawing U.S. companies overseas in the 1970s.

By 2020, almost all medical protection supplies in the U.S. were made in other countries.

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“Dear Mr. President, The purpose of this letter is to make your office aware of a little-known national security threat.”

The year was 2010. The president was Barack Obama. The letter writer was Mike Bowen, a Fort Worth, Texas, medical mask maker on the verge of bankruptcy after rapidly ramping up his factory to supply enough masks for the H1N1 flu just a year before.

“The people that we’d hired, these hundreds of people that step in to save the United States, to save America. They were rewarded by getting in an unemployment line. I lost everything that I owned. Literally hocked the farm,” said Bowen’s business partner, Dan Reese. His retirement account had just $72, he said.

The story of their company, Prestige Ameritech, explains why the U.S. has failed to maintain a robust domestic medical supply manufacturing base.

Bowen and Reese had worked for the mask maker Technol, which until the 1990s made 87% of the surgical masks in the U.S. In 1997, Kimberly Clark bought Technol, and moved manufacturing to Mexico. Around the same time, other American mask makers shuttered their U.S. factories, moving mostly to China. Reese and Bowen bought the now-vacant Texas factory. But within 10 years, 90% of U.S. medical masks were being made overseas.

Every year, Prestige Ameritech asked the Defense Department to buy their masks, citing the Berry Amendment that dictates the military buy U.S.-made apparel. In response, the Defense Department told them their masks aren’t apparel.

“Year after year after year after year after year, up to and including the last bid. It was unbelievable,” said Reese.

In 2014, a confidential presentation obtained by the AP and “FRONTLINE” from HHS warned that the U.S. supply of medical masks was “nearly exhausted” and that 5.3 billion would be needed in a pandemic.

In February 2017, more than two years before the pandemic, Prestige Ameritech tried again: “Dear President Trump: 90% of the United States protective mask supply is currently FOREIGN MADE!”

Again, Prestige Ameritech was ignored. And as the pandemic rolled in, shipments of testing swabs, surgical gowns, protective masks and hand sanitizer plummeted just as demand was soaring. Countries that did make PPE required manufacturers to sell all or part of their production internally, and U.S. governors found themselves in a bidding war for what was left.

In March, the Prestige Ameritech founders were furious to see the CDC advise health care providers to use homemade masks, like bandanas or scarves, for care of patients with COVID-19 as a last resort.

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“I felt that the government was intentionally misleading the people because they had not prepared as they should have, and the products are not available,” said Reese.

Flooded with calls, Prestige Ameritech shut down its internet sales page -- orders had jumped from two to three a month to thousands a day. They hired new staff and bought raw materials, speeding up production.

Over eight months this year, domestic manufacturing around the U.S. of medical supplies has accelerated. Hospitals and labs, even public libraries, have used 3D printers to make swabs. Needle and syringe factories are working overtime. Apparel companies are now making gowns. Alcohol distillers produce hand sanitizer.

But Chinese and Asian manufacturing has ramped up even more quickly, continuing to flood U.S. markets with less expensive alternatives. There were more than 2,000 shipments of N95s from Asia over the past month, up from 20 shipments during the same period a year ago, according to Panjiva Inc., a service that independently tracks global trade.

Experts agree that one solution is a massive investment in U.S. manufacturing that not only allows existing companies to expand, but guarantees a long-term market for medical supplies that are more expensive than those made by Asian competitors. There is no sign that this is going to happen.

“The challenge really is that China has 50% of the world’s production capacity, particularly for masks. So are we going to move an entire supply chain over?” said Cameron Johnson, a Shanghai-based trade consultant. “It’s just not going to happen. Manufacturing, as we know it, is never going to return.”

In Fort Worth, Prestige Ameritech is focused on the moment, bracing for more mask demand as people return to school, work and indoor events. But the future looks grim.

“The bottom line is China can sell masks into the U.S. market in my territory for cheaper than my raw material costs,” said Reese. “People can stand up and wave the flag, and we all do, but the truth is, there has to be a fundamental change to make all that happen.”

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Even as she grew sicker, Sandra Oldfield worried about mask shortages. This spring, as paramedics raced to her home, her thoughts were with the EMTs. Would they have the face masks they need, or would they be exposed to infection, as she was?

“Let them know that I’m positive so they can be as protected as they can,” she told her sister.

UC San Francisco Medical Director Dr. Josh Adler was similarly concerned. The more his staff needed personal protective gear, the harder it was to find. They sorted through counterfeits, off-brands and outside donations. Medical students were running PPE drives.

“At some point I had the thought, how is it that we can’t get more? Like, why? Why?” he said. “In life, when you run out, you just get more.”

Months earlier, a Jan. 27, 2020, email obtained through a Freedom of Information Act request makes it clear that some in the federal government were well aware medical-grade masks were going to be needed.

“We are likely to see person-to-person spread of the virus in the U.S. in the near future; CDC will begin to gently articulate this message into their public posture,” said a Department of Homeland Security memo.

At the same time, across the world in China, factories that make most of America's medical supplies were shuttered as the country locked down to try to control its own outbreak. When they did start up again, those lifesaving supplies were kept for the Chinese market, leaving U.S. hospitals understocked and desperate as cases of COVID-19 shot up.

It would be many weeks before China’s exports resumed. Meanwhile, the U.S. needed billions of N95 masks that simply weren’t available.

Despite early warnings from inside the White House, the federal government failed to substantially mobilize domestic manufacturers until April, three months after the virus began spreading exponentially across the U.S.

The impact of the virus varies greatly from country to country. But it is now clear that those with well-managed, diverse and flexible supply chains were able to protect against the deadly spread in ways the U.S. failed.

Amid the chaos, AP and “FRONTLINE” found counterfeit masks flooded the market, tracking some back to a factory in China. Dr. Philip Clapp at the University of North Carolina tested a handful of different masks collected by the AP, including ones imported by a non-profit relief organization, others donated to frontline workers by major tech firms, and masks AP had handed out to its own staff.

“All of it was counterfeit, as defined by OSHA’s definition of counterfeit or fraudulently labeled,” said Clapp. Every mask. Some were less than 50% effective, about the same as a cotton T-shirt.

AP sent new masks to staff who had received counterfeits.

The warnings of looming and potentially deadly supply shortages from the White House began confidentially in February when White House trade adviser Peter Navarro wrote to the COVID-19 task force, urging the administration to halt exports and ramp up production of N95 masks.

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The U.S. “faces the real prospect of a severe mask shortage!” he wrote on Feb. 9.

In addition to halting exports and prohibiting the sale of N95 factory equipment to China, Navarro pleaded that the U.S. government must provide “immediate purchase guarantees for all U.S. supplies at maximum production capacity.”

President Donald Trump initially rebuffed calls from states, medical workers, Congressional Democrats and domestic manufacturers to invoke the Defense Production Act, which allows the federal government to boost manufacturing. He said it wasn't necessary, but then abruptly reversed course in the spring, giving a few U.S. factories support they needed to expand production of N95s and the raw materials used to make them. But even now, those manufacturers haven’t received long-term purchase guarantees.

And according to health care workers, the Government Accountability Office and even the FDA, N95 masks continue to be in short supply. The White House denies this.

Rear Admiral John Polowczyk, supply chain task force lead at the Federal Emergency Management Agency, said they were diverting N95s originally ordered for the Strategic National Stockpile to hospitals, which should have plenty by now.

“Why any individual hospital would choose to have a nurse or doctor reuse a mask today ... I can’t reconcile that for you,” he said.

Navarro also insisted that medical supply chains have now stabilized, but stressed the dangers of relying so heavily on Chinese goods.

“We cannot forget the lesson, the key lesson, which is we need to bring our pharma home and our equipment home,” Navarro told AP and “FRONTLINE.”

Reshoring has become a rallying cry for both Republicans and Democrats in the run-up to the 2020 presidential election.

At the Republican National Convention in August, Trump stood before the White House and declared, “Over the next four years, we will make America into the manufacturing superpower of the world. We will … bring home our medical supply chains, and we will end our reliance on China once and for all.”

Similarly, Democratic nominee Joe Biden rolled out a plan to invest $700 billion to bolster U.S. manufacturing and purchase domestically made goods.

Heading into winter, the government now needs hundreds of millions of needles and syringes to vaccinate the nation, items Navarro warned earlier this year were in short supply.

“We may find ourselves in a situation where we have enough vaccine but no way to deliver all of it,” he said in a February memo to the White House coronavirus task force.

Now the Trump administration says needles and syringes are on order, but details of the contracts are shrouded in secrecy. AP and “FRONTLINE” learned that the largest has gone to a company making a device that has not yet been cleared by the FDA, according to its own website. Another firm only incorporated in May, and has never before had a government contract nor imported needles and syringes. A third contractor in August reported disruptions in its overseas supply chain.

Last week, the department of Health and Human Services refused to say if — or how many — needles and syringes have been delivered, claiming that information is “business sensitive.” Several contractors said the government has forbidden them from disclosing any information, even if they want to.

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Each week the CDC receives forecasts of national COVID-19 deaths for the coming month from about 40 different expert modeling groups. The agency uses those to create a national ensemble forecast. To date, the predictions of total deaths keep going up, each dot on the graph a life, a family, a community.

How Sandra Oldfield, the Fresno nurse, came to be a dot on that graph can be debated. Kaiser Permanente says it has followed state and federal guidelines and is “prudently managing PPE supplies.”

For weeks, as Oldfield fought for her life in the intensive care unit, her family sat outside in the hospital parking lot, praying and growing ever more despondent and terrified. When her dog Freckles died, they didn’t tell her.

“They’re going to put me on a ventilator,” Oldfield told her sister, Lori Rodriguez, in a phone call.

Rodriguez had known this was coming. “We’re going to be right here when you open your eyes,” she said.

Two months after Oldfield fell ill, Rodriguez knew she needed to let sister her go. A nurse held the phone to Oldfield's ear.

“I told her that it was OK, that she didn’t have to hold on anymore, that we were going to be OK. And we would see her again,” Rodriguez said. “And that’s when she took her last breath.”

Oldfield’s friends and family say there’s plenty of blame to go around: The hospital should have protected her. And if the government hadn’t failed in its obligation to maintain supply chains for essential equipment, she might not have wound up fighting for her life, in the same hospital where she helped save so many others.

Hundreds wanted to come to Oldfield’s graveside ceremony -- colleagues, family, friends -- but COVID-19 limited the service to 10. In her casket, her family placed an urn, the ashes of Freckles.

EDITOR’S NOTE — This story is part of an ongoing investigation by The Associated Press, the PBS series “FRONTLINE,” and the Global Reporting Centre that examines the deadly consequences of the fragmented worldwide medical supply chain and includes the film “America’s Medical Supply Crisis,” premiering on PBS and online Oct. 6 at 10 p.m. EST/9 p.m. CST.

Contributors to this story included AP writers Candice Choi in New York, Matthew Perrone in Washington, D.C., and Allen G. Breed in Chapel Hill, North Carolina, and Global Reporting Centre executive director Peter Klein in Vancouver, Canada, and “FRONTLINE” co-producer Kate McCormick in Stamford, Connecticut.

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