Despite Trump's declared exit from the WHO, officials continued working toward reforms and to prevent withdrawal. This week, they were told they must justify any cooperation with the WHO on the grounds of national security and public health safety.
This article was first published on Saturday, June 20, 2020 in ProPublica.
Right before President Donald Trump unveiled punitive measures against China on May 29, he inserted a surprise into his prepared text.
“We will be today terminating our relationship with the World Health Organization,” he announced during a press conference in the Rose Garden.
Most of the president’s top aides — and even some of his Cabinet secretaries — were blindsided.
Just 11 days earlier, Trump had sent an ultimatum threatening to withdraw from the WHO if reforms were not enacted in 30 days. Some senior officials hoped that he was bluffing or would change his mind about a decision that could hobble efforts to fight dangerous diseases.
Trump’s foreign policy choices are at the center of a forthcoming book by former national security adviser John Bolton, who argues that many of the president’s erratic actions are aimed at boosting his re-election chances.
But while Bolton’s book focuses on revelations about Trump’s past dealings with Turkey, Ukraine and China’s leader Xi Jinping, officials interviewed by ProPublica said the less explored WHO decision may have a more lasting impact.
ProPublica has interviewed senior officials at five federal agencies to understand the repercussions and the behind-the-scenes efforts to contain the damage of a decision in which they had little input.
In the weeks after Trump’s Rose Garden declaration, the White House gave little direction on what to do next. Officials who deal with the WHO knew that withdrawal is a cumbersome process requiring a year’s notice, a multiagency review and payment of unpaid dues.
As a result, Health and Human Services Secretary Alex Azar instructed his department to continue cooperating with the organization. The American ambassador in Geneva, Andrew Bremberg, kept negotiating with the WHO director general on the reforms demanded by the president, including an independent inquiry into the WHO’s response to the pandemic. (The talks were first reported by Vanity Fair.) Dozens of scientists, doctors and public health specialists detailed from the Centers for Disease Control and Prevention kept working at their posts at the WHO’s Geneva headquarters and in the field, fighting Ebola and other diseases in Africa and elsewhere.
But on Monday, the administration made it clear there would be no backing down.
At a meeting at the White House, a director with the National Security Council told diplomats and health officials that they must now justify any engagement with the WHO as being necessary for national security and public health safety, senior government officials told ProPublica. In addition, the State Department has begun preparing formal paperwork to declare the official withdrawal of the United States from the WHO, officials said.
“The president is moving toward a fast withdrawal,” a senior administration official said in an interview this week. Another administration official said on Friday that the White House does not plan to reconsider the decision. National security and health officials confirmed those assertions.
“The President has made clear that the U.S. is terminating its relationship with the World Health Organization, and that process is being expedited,” said Katie McKeogh, an HHS spokesperson, in an email response to a request for comment. “All US-WHO collaborations are being examined through an interagency exercise as part of the termination process to ensure the safety of the American people will be protected.”
The new “no-engagement” policy is a concrete step to curtail the relationship, and it has caused alarm and confusion, other officials said.
“This is sending just unbelievable shock waves through the agencies,” a senior government official said. The official warned that reduced cooperation with the WHO will have “profound and severe repercussions.”
Among the most immediate potential impacts: The move could for the first time cut the U.S. government out of the development of the seasonal influenza vaccine for the Southern Hemisphere, a process coordinated by the WHO in partnership with the United States. And the withdrawal from the WHO could impede access to an eventual COVID-19 vaccine if it is created overseas, current and former officials said.
Leaving the organization could also significantly blind the U.S. to health threats in remote foreign locales that, as the pandemic has shown, have the potential to make their way to the U.S. shores. Experts also fear the impact on major initiatives to combat infectious diseases, such as a WHO-led program that is on the cusp of eradicating polio.
“To do this in the middle of a pandemic is breathtakingly dangerous,” said Nancy Cox, a former CDC virologist, who for 22 years led the agency’s WHO center on influenza surveillance and control. “So I worry a lot about what’s going to happen to so many of the programs at WHO that were strongly supported financially and through expertise and consultation with the U.S. I just think it could be really bad.”
When informed of the NSC directive, a WHO spokesman in Geneva wrote that the organization “hopes the United States will remain part of WHO, as it has been since 1948. Its leadership in global public health as a WHO Member State is important to all people, everywhere.”
The United States is the largest donor among the WHO’s 194 member states, giving about $450 million last year. The WHO said the U.S. cut in funding would affect childhood immunizations, polio eradication and other initiatives in some of the most vulnerable parts of the world.
Trump’s disgust with the WHO is well-founded, administration officials say. The decision to leave wasn’t solely due to the WHO’s stumbles on COVID-19, but because they capped a record of unresolved structural issues and failures during crises, officials said. As the pandemic spread early this year, the WHO reported that only 1% of cases were asymptomatic, while Chinese doctors were privately saying that the number was actually as high as 50%, the senior administration official said.
“The organization had no credibility,” the official said. “It was either clueless or cut out, being manipulated.”
Recent missteps, including conflicting advice about the efficacy of masks, raised further questions, officials said.
The administration plans to fill the void left by its withdrawal with direct aid to foreign countries, creating a new entity based in the State Department to lead the response to outbreaks, according to interviews and a proposal prepared by the department. The U.S. will spend about $20 billion this year on global public health. (About $9 billion of that is emergency aid for COVID response.)
But the senior administration official conceded that important activities led by the WHO, including vaccination initiatives, need to continue. It is not yet clear what will happen to those programs when American funding and participation end, the official acknowledged.
In fact, many aspects of the new policy toward the WHO remain unclear, officials said. At the White House meeting Monday, the NSC director who outlined the policy did not answer a number of questions from the agencies about its implementation and impact, saying responses would come later, the senior government official said.
The new directive will require officials to divert their attention from pandemic response in order to review a list of their WHO-related activities and try to justify them on national security and public health safety grounds, the senior government official said.
Critics warn of potential widespread damage as the United States attempts to extricate itself from an international health infrastructure in which it is entrenched. The timing will cause even more uncertainty, they said.
A case in point: The flu vaccine that Americans receive at drugstores and doctors’ offices is based on work that the CDC and Food and Drug Administration conduct through the WHO.
Since 2004, the U.S. has helped build a global network of WHO flu centers, buying lab equipment and training scientists. The centers in more than 100 countries collect samples from sick people, isolate the viruses and search for any new viruses that could cause an epidemic or pandemic. The CDC houses one of five WHO Collaborating Centers that collect these virus samples, sequence the viral RNA and analyze reams of data on flu cases around the world, while the FDA runs one of the four WHO regulatory labs that help vaccine makers determine the correct amount of antigen, which triggers the immune response, to include in vaccines.
The U.S. and other WHO members meet twice a year to pick the dominant flu viruses that are included in vaccines. The strains for this fall’s flu vaccine in the U.S. were chosen in April. But in September, the WHO flu centers are scheduled to pick the flu strains for the Southern Hemisphere’s vaccine, and months of work at the CDC leads up to that meeting.
The uncertainty has caused concern in the pharmaceutical industry as well as the government, officials said. The CDC could lose access to the data and virus samples that protects Americans from potentially deadly strains of flu from around the world.
“If we pull out of the World Health Organization, we’re going to be flying blind in terms of influenza and other pandemic threats,” said Cox, the CDC flu expert, who retired in 2014. “It’s going to be a lot harder to know what’s going on.”
The onslaught of the coronavirus has hurt immunization activities worldwide, causing a rise in measles and other diseases. American cooperation with the WHO is vital to fighting such threats, according to current and former officials. They fear that the U.S. decision will endanger a WHO-led program that has come tantalizingly close to the eradication of polio. The wild form of the disease now lingers in just two countries, Pakistan and Afghanistan.
“We are using WHO to run an anti-polio campaign and coordinate it,” said Andrew Natsios, a former administrator of the U.S. Agency for International Development and director of the Scowcroft Institute of International Affairs at Texas A&M University. “And we’re almost there. We can’t stop that now.”
The Trump administration’s plan to bypass the WHO and address global health problems directly with foreign governments will run into trouble in the Middle East, South Asia, Africa and other regions where Americans encounter hostility or have difficulty operating, critics said.
“People coming into countries in WHO shirts to work on polio or AIDS are less threatening,” said former Ambassador Jimmy Kolker, a veteran health diplomat who represented the United States at WHO meetings until 2017. “It is easier to get collaboration from a skeptical country or population through WHO. It facilitates access.”
It is fanciful to think that other nations will accept a U.S.-led health initiative as a substitute for the WHO, Kolker said.
“No one is looking for U.S.-based alternatives to WHO,” he said. “Dead on arrival. There is no way they are going to be supported or even accepted.”
The WHO has a history of bringing together ideological rivals. William Foege, a CDC director under Presidents Ronald Reagan and Jimmy Carter, credits the global agency for uniting American scientists and their counterparts from the Soviet Union during the Cold War to eradicate smallpox in a little more than a decade.
“It’s not a failed bureaucracy,” said Foege, who worked on the international fight against smallpox. “If you go there and see all they do every year, and they have a budget for the entire world that’s smaller than many medical centers in this country.”
At the same time, global health experts across the political spectrum admit that the WHO needs reform. The organization does not have the muscle to enforce international health regulations or put pressure on member states, experts say. Its decentralized structure gives the headquarters in Geneva limited power over regional offices, some of which have been fiefs dominated by politics and patronage.
During the U.S. response to the Ebola outbreak in West Africa in 2014, the Obama administration’s displeasure with the WHO led American officials to bypass the agency and join forces instead with other nations and nongovernmental organizations, current and former officials said.
The WHO’s flawed record shows the need for the United States to take the lead in response to health crises, a senior administration official said.
“As U.S. leadership demonstrated in the Ebola and MERS outbreaks, our diplomatic and development efforts enable countries to develop tools for addressing infectious disease,” the official said. “Due to these efforts, we filled gaps created by the WHO’s inaction to prevent, detect and respond to outbreaks immediately.”
Kolker said the calls for reform are legitimate, but he and others said the United States has enough influence to make changes from within. They disagree with the allegations that China controls the WHO and its director general, Tedros Adhanom Ghebreyesus.
“In general, the WHO is deferential to member states,” Kolker said. “Yes, it should have been more aggressive in response to Chinese obstruction. Tedros surely realizes the public statements were too deferential to China. But the organization is not dominated by China. Its weaknesses reflect the challenges we have long faced in international collaboration on public health.”
China will gain control over the organization if Washington really does terminate its membership, current and former officials predicted.
“There’s one country that’s desperate for the United States to leave the WHO, and that’s China,” Sen. Chris Murphy, a Connecticut Democrat, said at a hearing Thursday of the U.S. Senate Committee on Foreign Relations. “They are going to fill this vacuum. They are going to put in the money that we have withdrawn, and even if we try to rejoin in 2021, it’s going to be under fundamentally different terms because China will be much more influential because of our even temporary absence from it.”
The plastic tubes supplied for coronavirus testing by Fillakit, a first-time federal contractor with a sketchy owner, don’t even fit the racks used to analyze samples. And they may be contaminated anyway.
This article was first published on Thursday, June 18, 2020 in ProPublica.
Since May, the Trump administration has paid a fledgling Texas company $7.3 million for test tubes needed in tracking the spread of the coronavirus nationwide. But, instead of the standard vials, Fillakit LLC has supplied plastic tubes made for bottling soda, which state health officials say are unusable.
The state officials say that these “preforms,” which are designed to be expanded with heat and pressure into 2-liter soda bottles, don’t fit the racks used in laboratory analysis of test samples. Even if the bottles were the right size, experts say, the company’s process likely contaminated the tubes and could yield false test results. Fillakit employees, some not wearing masks, gathered the miniature soda bottles with snow shovels and dumped them into plastic bins before squirting saline into them, all in the open air, according to former employees and ProPublica’s observation of the company’s operations.
“It wasn’t even clean, let alone sterile,” said Teresa Green, a retired science teacher who worked at Fillakit’s makeshift warehouse outside of Houston for two weeks before leaving out of frustration.
The Federal Emergency Management Agency signed its first deal with Fillakit on May 7, just six days after the company was formed by an ex-telemarketer repeatedly accused of fraudulent practices over the past two decades. Fillakit has supplied a total of more than 3 million tubes, which FEMA then approved and sent to all 50 states. If the company fulfills its contractual obligation to provide 4 million tubes, it will receive a total of $10.16 million.
Officials in New York, New Jersey, Texas and New Mexico confirmed they can’t use the Fillakit tubes. Three other states told ProPublica that they received Fillakit supplies and have not distributed them to testing sites. FEMA has asked health officials in several states to find an alternative use for the unfinished soda bottles.
“We are still trying to identify an alternative use,” said Janelle Fleming, a spokeswoman for the New Jersey Department of Health.
Fillakit owner Paul Wexler acknowledged that the tubes are normally used for soda bottles but otherwise declined to comment.
The Fillakit deal shows the perils of the Trump administration’s frantic hiring of first-time federal contractors with little scrutiny during the pandemic. The federal government has awarded more than $2 billion to first-time contractors for work related to the coronavirus, a ProPublica analysis of purchasing data shows. Many of those companies, like Fillakit, had no experience with medical supplies.
The U.S. has lagged behind many European countries in its rate of testing people for the coronavirus, partly because of supply shortages or inadequacies. Epidemiologists say testing is vital to tracking the virus and slowing transmission. In at least one state, the shipment of unusable Fillakit tubes contributed to delays in rolling out widespread testing.
“They’re the most unusable tubes I’ve ever seen,” said a top public health scientist in that state, who asked to remain anonymous to protect his job. “They’re going to sit in a warehouse and no one can use them. We won’t be able to do our full plan.”
In a written response to questions, FEMA said it inspects testing products “to ensure packaging is intact to maintain sterility; that the packing slip matches the requested product ordered, and that the vials are not leaking.” It said that “product validation” that medical supplies are effective “is reinforced at the state laboratories.”
The agency did not answer questions about the size and lack of sterilization of Fillakit’s tubes or about why it sought an alternative use for them.
Fillakit is one of more than 300 new federal contractors providing supplies related to COVID-19. A ProPublica analysis last month found about 13% of total federal government spending on pandemic-related contracts went to first-time vendors. FEMA said last month that it only pays for products once they have been delivered, minimizing the risk of wasting taxpayer dollars.
“FEMA does not enter into contracts unless it has reason to believe they will be successfully executed,” it said.
Preforms, the small tubes also known in the plastics industry as “baby soda bottles” or “blanks,” have a following among elementary school science teachers and amateur scientists, but they don’t meet rigorous laboratory standards. They’re much cheaper than glass vials and can be sealed off with a soda bottle cap. When inflated with high-pressure air, the soft plastic expands to the size of a 2-liter soda bottle.
The preforms arrive at Fillakit’s warehouse in a huge shipping container. The tubes are then shoveled into smaller bins. Workers add the saline solution and screw on caps. The tubes are then loosely piled in bags and sent to FEMA, which forwards them to the states. Typically, test tubes are individually packaged to guard against contamination.
Washington state, an epicenter of the first outbreak of the virus, got more than 76,000 Fillakit vials from FEMA. None can be used.
“They were packaged unusually,” said Frank Ameduri, a spokesman for the state Health Department. “Not in a way we’re used to seeing, and they were not labeled. Some of them have been sent to our lab for quality control. None of the vials will be used until we’ve identified what’s in them and that they are safe for use.”
About 140,000 Fillakit tubes are also shelved in Texas, where officials were slow to roll out testing. The number of confirmed cases in Texas has increased by more than one-third in the past two weeks, according to data gathered by The COVID Tracking Project.
“There were issues with the labeling, and they use saline rather than viral transport medium, so we have not used them for our testing efforts,” said Chris Van Deusen, a spokesman for the Texas health department.
The U.S. Food and Drug Administration has only validated one solution, known as viral transport medium, as reliable in preserving the coronavirus RNA from decay or destruction by substances in the container. However, because that medium is in short supply, the FDA has also granted an emergency authorization for other products it believes can keep the virus intact for up to three days.
Fillakit has been squirting one of the alternatives into its tubes, phosphate buffered saline, which the FDA says should be placed into “a sterile glass or plastic vial.”
A spokeswoman for the Maryland-based Association of Public Health Laboratories, a membership organization that writes best practices and helps connect public health labs with government agencies, said it has heard rumblings about Fillakit’s tubes but “nothing deadly.”
“The bigger issue is the size of the tubes,” said the spokeswoman, Michelle Forman. “They are an unusual shape so they don’t fit racks, and we are getting lots of pushback about how difficult it is to work with them from our clinical partners.”
Richard Loeb, a contract law expert at the University of Baltimore, said FEMA has the power to claw back money paid to contractors, remove them from the government’s list of approved vendors or refer them to the agency’s inspector general.
“It’s outrageous enough that they [FEMA] ordered something to test for COVID-19, and they got something that can’t be used to test for COVID-19,” Loeb said. “I still am a little bit troubled as to why FEMA accepted them. ... They may have stupidly accepted something that was nonconforming.”
Wexler, Fillakit’s owner, has a background in law and real estate, not medical supplies. In 2012, the Federal Trade Commission accused Wexler and his telemarketing firm of illegal robocalling, making unauthorized charges to consumers’ bank accounts and falsely claiming to be a nonprofit organization. Wexler’s firm allegedly misrepresented itself as a credit counseling service for several years, charging customers for work it did not do, according to court records.
Wexler, who denied the charges, settled the case a year later. The settlement banned him from offering debt relief services — but not from being a federal contractor — and imposed a $2.7 million judgment.
Fillakit and another Wexler company, Cleargate Labs, operate out of the same warehouse in The Woodlands, a sprawling Houston suburb.
Cleargate describes itself as a “network of primary clinical laboratories” on its website. Last year, the company cold-called an elderly Iowa woman, told her that it was marketing a DNA screening for cancer genes and offered to send her testing supplies in exchange for her Medicare number, the Tampa Bay Times reported. Suspecting a scam, the woman reported the company to local law enforcement. Cleargate did not bill her and was not charged with a crime.
Three former Fillakit employees said that its process was unsterile. Workers shoveled up the tubes from unsanitary surfaces. The liquid that they added to each tube to preserve samples for lab analysis was kept in trays exposed to the air, which was whipped around by large fans.
Standards were compromised in the rush to meet productivity goals, Green said. “At the beginning, they were being picky, saying, ‘You have to make sure it’s at least 2 milliliters.’ And sometimes there were tubes that didn’t have any [solution] in there,” she said.
Wexler would come in and “cuss and scream at everybody in this warehouse about how nobody’s paying attention to what they’re doing,” she said.
Wexler and Stephen Wachtler, a manager at Cleargate and Fillakit, “were telling us, ‘Yeah, we gotta have four bins by lunch,’” Green said. “‘We gotta have 10 bins before you leave at 5 o’clock. Work faster, work faster.’”
Green said that few employees at the company had backgrounds in science or medicine. In May, during Fillakit’s first week of operations, the company did not provide workers with face masks, she said, raising concerns that fluid from their noses and mouths could land inside the tubes. Later, supervisors did hand out masks but did not require employees to wear them.
On June 10, a ProPublica reporter observed workers, some not wearing masks, standing over snow shovels and bins of tiny soda bottles.
Wexler and workers loaded a shipment of tubes into an Enterprise rental truck, which lacked the refrigeration that the Centers for Disease Control and Prevention say is needed to safely transport legitimate testing supplies.
Wexler denied a request to tour the warehouse. Asked about the lack of sterile conditions and the use of soda preforms, Wexler screamed, “What’s your problem, man?”
Michelle Hardy, a retired nurse who worked at Fillakit through June 10, said her concerns about contamination were dismissed by Wachtler. He did not respond to requests for comment.
“I kind of said to Stephen, ‘Is this supposed to be, like, clean technique, or sterile technique or what?’” Hardy said. “He’s like: ‘No, it’s fine. It’s fine what you’re doing because they’re just testing for COVID, and so if there’s any other bacteria or viruses in there then it’s not going to show up.’”
That’s not true, according to Vjollca Konjufca, an associate professor of microbiology at Southern Illinois University. If Fillakit employees were infected, they might have contaminated the tubes with their own virus, potentially causing false test results, she said.
Konjufca was part of a team at her university that manufactured the viral transport solution validated by the FDA. She said they followed strict protocols to ensure tests aren’t contaminated.
“We filter-sterilize, and then we add antibiotics,” Konjufca said. “The whole work is handled under a biosafety hood ... so it does not allow any sort of air from the room, particulates or whatever, to get into your vials.”
There are many ways to mess up medical testing, so careful manufacturing is vital. Some substances in saliva or the plastic vials can damage virus RNA and alter test results, Konjufca said.
“You cannot just makeshift use soda bottles to make tubes,” she said. “You have enzymes in there and you have contaminants that can mess up the results.”
It's been six months since researchers in China said they had identifieda novel coronavirus spreading in the city of Wuhan. Hope and desire for a vaccine to end the global devastation is growing with each passing week.
Almost every day, I hear people making plans around the eventual arrival of a coronavirus vaccine — office reopenings, rescheduled weddings, family reunions and international travel. In recent weeks, colleagues and friends have asked me with growing urgency: "When will we have a vaccine? Will it be any good?"
At the same time, other friends have been telling me, "When I hear that this is going to be the fastest vaccine developed ever, that doesn't make me feel good — it makes me feel nervous that they're going to cut corners."
These questions and concerns resonate with me. I, too, want a vaccine, but I want reassurance that it's truly safe and effective. So I talked to a dozen people in the vaccine world: scientists, pediatricians, pharmaceutical manufacturers, as well as staff at the National Institutes of Health and the Food and Drug Administration.
Let me tell you this up front: If you're imagining there'll be one golden day when a vaccine is approved and the pandemic will be over — Finally! We can all crowd into one another's living rooms and resume choir practice again — I'm afraid it won't be quite like that. But it will be the beginning of the end.
There's much to be hopeful about, and enormous challenges lie ahead. Let's dig in.
Scientists Are Optimistic About a COVID-19 Vaccine
Everyone I spoke to was optimistic that manufacturers would eventually develop a COVID-19 vaccine. This isn't just because there are so many scientists and pharmaceutical companies working on the endeavor, and so much money being poured into it, though that also raises the chance of success.
The goal of vaccine developers is to mimic a natural infection as closely as possible without getting a healthy individual sick. There are many ways to do this. You can give a person a weakened virus or a dead virus. You can also show the immune system just part of the virus. Many manufacturers are creating vaccines involving only the "spike protein," the part on the surface of the coronavirus that attaches to the human cell it is trying to enter. Once the immune system has learned what the spike protein looks like, when it encounters it again, as part of a real coronavirus, it should know how to defend itself.
Dr. John Mascola, director of the Vaccine Research Center at the NIH's National Institute of Allergy and Infectious Diseases, said he is hopeful because our natural immune system, when healthy, is capable of handling the infection. "Most of the time, people recover from COVID-19, because their immune system eventually clears the virus," he said. He contrasted the coronavirus to HIV, for which scientists so far have struggled to create an effective vaccine: "In HIV, the natural immune system is not effective and people get AIDS." In this virus's case, if we can mimic a natural infection closely enough, it's likely that a vaccine will work.
The Coronavirus Is Not the Flu. In This Case, That's Good News.
There are some vaccines that are extremely effective, like the MMR vaccine: One dose is about 93% effective at preventing measles; two doses (which is what's recommended) are about 97% effective.
Other vaccines aren't as perfect. The flu shot's effectiveness varies year to year. During the 2019-20 flu season, it was about 45% effective at preventing infections, according to the CDC. The year before, it was just 29% effective.
The experts I talked to said that the flu shot was an outlier because of the rapidly shifting nature of the influenza virus. Because of its frequent mutations, developers have to make each year's vaccine based on educated guesses on what strains of the flu virus will be circulating next year. Sometimes, they misjudge, resulting in a vaccine that doesn't exactly match up with the flu strains that are most prevalent the following season.
"Influenza changes year in, year out, and the people who get it tend to be extremes in age — elderly and children — so you don't tend to have as good an immune response," said Dr. Nicholas Kartsonis, infectious disease and vaccines clinical research lead for Merck, which has two COVID-19 vaccine candidates that it plans to start in human trials this year.
One lucky break COVID-19 vaccine developers have had is that this coronavirus hasn't mutated in any significant way so far, including, crucially, the part that is most visible to the immune system, that spike protein. So long as that remains true, the vaccine they make should match up with the virus that our bodies will encounter in the real world, meaning it'll likely work as intended. Given the stability seen so far in the coronavirus's genetic sequence, "I am hopeful that when we do develop a vaccine, it will provide long-term protection," Kartsonis said.
Even a Vaccine That's Not 100% Effective Could Be Good Enough
When vaccine manufacturers talk about "effective," there are two common definitions. One is preventing people from getting sick. The other is preventing people from getting infected at all. In the case of COVID-19, this could be a nontrivial difference.
We know now that many people infected with the coronavirus may be asymptomatic carriers, which means that they never feel sick or get symptoms like a cough or fever, even if they are, in fact, infected with the virus. So you can have a vaccine that is effective in that it prevents symptomatic COVID-19, but that doesn't mean it'll stop everyone from being infected.
Let's be clear: A vaccine that can significantly reduce sickness would be fantastic. If a vaccine can reduce the severity of COVID-19 so that it's far less deadly, decrease hospitalizations and minimize symptoms even for those who catch it, that's a win.
"In terms of what you'd expect for approval, it should at least be 50% efficacy against symptoms and 70% against moderate to severe disease, to keep you out of the hospital," said Dr. Paul Offit, director of the vaccine education center at the Children's Hospital of Philadelphia.
Even so, it's important not only to measure what the vaccine does, but also for politicians, health officials and journalists to clearly explain to the public exactly what it is that the vaccine is capable of doing. If it ends up that the first vaccine to go to market is "70% effective," we should be clear on whether it is 70% effective at reducing sickness or infection, so members of the public have the appropriate context and don't feel let down if they are vaccinated and still get a mild case of COVID-19.
Large Scale Trials Will Tell Us if the Vaccine Works
When experimental vaccines are tested, they usually go through three phases of clinical trials. The first phase is the smallest and focuses on safety, making sure that the product doesn't have any dangerous health effects. The second is a little larger, continuing to gather safety data while testing if the vaccine can induce an immune response, producing antibodies in participants. The third trial is the largest, and it needs to be big enough to confirm that the vaccine is actually effective in the real world.
Moderna Therapeutics is currently expected to be the first U.S. manufacturer to start a phase 3 trial. Candidates by AstraZeneca and Johnson & Johnson will follow, according to The Wall Street Journal. Moderna's trial is planned to begin in July and will enroll about 30,000 participants. Half will get the vaccine and half will get a placebo, according to Moderna's chief medical officer Dr. Tal Zaks. (I should disclose: Paul Sagan, chairman of ProPublica's board, is also one of Moderna's board members. That said, ProPublica's board members have no say in what reporters write about, nor do they know about articles before they are published.)
The participants will be tracked carefully throughout the study. If they have any symptoms related to COVID-19, they'll get tested to see if they have contracted the virus. The participants will also get blood drawn at regular intervals to get tested for antibodies, which will determine if they got infected but perhaps didn't know because they didn't develop symptoms.
"But wait!" you say. "Doesn't a vaccine also create antibodies? How can you tell by looking in a participant's blood whether the antibodies come from the vaccine or from an infection that the vaccine failed to prevent?" Excellent question.
At least for Moderna's vaccine trial, here's how they're going to tell the difference: Moderna's vaccine is what's known as an mRNA vaccine. Instead of using the actual virus or even a little bit of the virus, it uses a piece of genetic code, kind of like a recipe, that gives instructions for making the spike protein. Once injected into the arm and introduced into human cells, the cell's protein-making factories read the recipe and manufacture the spike protein, churning out copies for the immune system to check out. The immune system should then create antibodies that correspond to the spike protein, like a matching puzzle piece.
When you get infected by an actual coronavirus, however, there are more parts to it than just the spike protein. Your body will produce other antibodies that match up with other parts of the virus, including what's called the nucleoprotein, found inside the virus. We can also measure for those antibodies in a trial participant's blood, the NIH's Mascola explained. So if we find so-called NP antibodies, that means you've been infected for real, because there's no way you could induce NP antibodies from the vaccine alone.
The Moderna trial is designed to end when a predetermined number of people have gotten sick, according to Zaks. Then, the study investigators will count up the number of people that have gotten sick in the placebo arm and compare it with the vaccine arm. Hopefully, there will be far fewer in the vaccinated cohort.
There's one more question that a phase 3 trial cannot answer: How long will protection last? Right now, we don't even know if people who have gotten sick via natural infection have lifelong immunity. The only way to find out how long a vaccine's protection lasts will be to keep tracking study participants and whether their antibody levels drop over time. We may end up needing periodic booster shots. Truly, only time will tell.
Shortcuts Involve Trade-Offs
To give you a sense of what a blistering pace we are attempting to move at, consider that under normal circumstances, it typically takes 10 to 15 years to develop a vaccine. Creating the HPV vaccine was a 15-year journey from key research findings in 1991 until the vaccine was approved, initially for the prevention of cervical, vulvar and vaginal cancers, in 2006. Merck's Ebola vaccine, one of the fastest ever to be approved, still took about four years from start to finish, according to Kartsonis.
The speed of the phase 3 trials depends on the rate of infection wherever people are enrolled. If there is a huge outbreak going on, people in the placebo group will get sick at a high rate, and the trial may be over in a matter of a few months. If infection rates are very low, however, the trial could drag on for months on end. Moderna hasn't announced its trial sites yet, but it will have sites "well dispersed" in the U.S. and is considering international trials as well, according to a spokesman.
Among the many ways to shorten the vaccine development timeline, approving a treatment based on antibody data — without completing a phase 3 trial — could be contentious. This is why.
"There have been some European countries that wanted to be part of our trial, and we said: 'Look at your epidemiology, you're a victim of your own success — there's just not enough cases happening. It would take five years!'" Moderna's Zaks said. "So speed here is going to be enabled by what we anticipate is ongoing attack rates. We expect there will be infections amongst the participants on our trial."
Still, there have been discussions of some potential ways to speed up trials even more. One common proposal is to conduct what are known as challenge trials, in which vaccinated participants are deliberately "challenged" with the coronavirus to see if they get sick.
This idea was dismissed as unethical by some experts I interviewed. "We don't have a treatment — we can't guarantee to any volunteer that if we gave them a challenge with the actual virus, that it wouldn't make them very, very sick," said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt Medicine. "That would make a lot of people very uneasy."
The other shortcoming of approving a vaccine via a challenge trial is that because of the inherently risky nature of giving participants a live virus, challenge trials are typically very small. "That diminishes the safety database, and you need a large safety database to give us comfort to communicate to the public that we think that this is a safe vaccine," Schaffner said.
Another potential would be to green light use of a vaccine based on expected benefit, if manufacturers can show it reliably generates levels of antibodies in study participants that are similar to those found in people who have been naturally infected. Not everyone is a fan of that idea — some experts I interviewed told me that immune responses aren't always predictive of a vaccine's real-world capabilities.
Children and Pregnant Women Won't Be First in Line
In the phase 3 trials currently being planned, the vaccines will be tested in adults. People over the age of 55 are being specifically recruited, and it's important to include them because the need for the vaccine in that demographic is particularly high.
One group that won't be in the initial set of phase 3 trials: children.
This is for two reasons. First, as a safety precaution, the NIH's Mascola explained. Traditionally, when running trials with an experimental vaccine or drug, developers make sure it's safe in adults before moving on to children. Second, for the COVID-19 vaccine specifically, the most acute need isn't in children.
This means that when the vaccine is first approved, it likely won't be available for those under 18, because it hasn't yet been studied in that population. However, Mascola said there are already discussions for how to run future trials for children. Moderna will eventually run trials in children, Zaks confirmed.
Another special population is pregnant women. They are also not going to be enrolled in the initial phase 3 trial for the Moderna vaccine, according to Zaks. But Mascola said that it's essential that that population eventually be studied. "If we're not able to immunize women of childbearing age, that excludes a large proportion of the population. There's a strong interest in getting those studies done," he said. "The FDA is encouraging companies/sponsors to include in their development plans studies that would provide data to support use of COVID-19 vaccines during pregnancy," the agency said in a statement.
The FDA added that it "strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities." African Americans have been disproportionately affected by the pandemic, contracting the virus and dying at higher rates.
Manufacturing 'At Risk' Is a Safe Time-Saver
One strategy that everyone agreed was a safe way to save a whole lot of time without any risk to human health is what's known as "manufacturing at risk." This is one of the key components of the U.S. government's Operation Warp Speed, which is supporting five candidates with billions of dollars of federal funding.
Typically, drugmakers will manufacture only enough doses for clinical trials and make sure the trials are successful before starting mass production. Manufacturing at risk means that developers will instead begin mass production at the same time as clinical trials, which means that if a vaccine fails in human trials, they'll have to throw away all the product they've made, wasting money and materials. But if a product is successful, it means that the minute its trial is completed, there'll be millions of doses ready to go.
Manufacturing at a massive scale is no simple task. "If we're going to immunize 300 million people in the U.S. — we don't even do that with the flu vaccine every year — we need a lot of glass vials, we have to make sure we have printing supplies and paper to make the labels and package inserts, we need stoppers for the vials, and they all need to be made to a very high standard. All this in addition to the raw materials to the vaccine itself," Schaffner said.
Pfizer and its partner, German company BioNTech, are planning to have a few million doses ready by the end of the year, and hundreds of millions of doses available in 2021, even though the first of their four vaccine candidates just began its first early-stage human trials in May. The companies are currently preparing manufacturing facilities in St. Louis, Andover, Massachusetts, and Kalamazoo, Michigan, as well as in Europe, according to Dr. Philip Dormitzer, Pfizer's vice president and chief scientific officer for viral vaccines.
Development Is the First Hurdle, Distribution Is the Next Challenge
On the day that a vaccine is approved, you'll find me jumping up and down in my apartment, cheering loudly enough to startle my neighbors. And then … I'll keep on washing my hands, wearing a mask and maintaining social distancing.
Why? Because I know that when a vaccine is first approved by the FDA, there won't be enough available for everyone who wants it. There will need to be a prioritization, with the vaccine given first to those who need it most: essential workers and the elderly. As a healthy adult who is fortunate to be able to work from home, I'll be nowhere near the front of the inoculation line.
Distribution is going to be a massive challenge. "There's a need to have in place a mechanism to ensure people who should get the vaccine get it," Dr. Walter Orenstein, associate director of Emory University's vaccine center, said. "We won't have 8 billion vaccines. So who should get priority, and how should it get delivered? We will need to remove barriers to access, including cost and distance."
In all likelihood, we'll have several vaccines that come to market and are in use at the same time, because of the unprecedented need to vaccinate so many people around the globe. No one company has the manufacturing capability to make it all.
There may also be differences in what works best for different countries and populations. Some of the vaccines will require cold shipping or storage. Some will require two doses (Moderna's is a two-dose vaccine, taken a month apart). All these variations will add to the complexity of delivery and distribution.
"Since I have gray hair, I'm trying to remind my colleagues that in previous distribution and prioritization schemes, flexibility is very important," Schaffner warned me. He has long worked with the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practice, which reviews data on vaccines and gives recommendations on which populations they should be used for. He is now on the COVID-19 vaccine working group. "Adverse events will come up that have to become investigated. There will be bumps in the road. War plans are great, until the war starts. Then you will have to be flexible."
Safety Monitoring Doesn't End After Trials Are Over
Vaccinating 15,000 to 20,000 people before approval should give regulators a large pool of data to help them understand what side effects are to be expected and help ensure that the vaccines that go to market don't have any major safety issues.
But of course, 20,000 people isn't 20 million or 200 million or 2 billion people.
"When we have tens of thousands of people being evaluated, we can at least pick up safety signals for serious adverse events for the more frequent adverse events," Orenstein said. "Now for very rare events, if it's 1 per million, you're not going to catch that in clinical trials."
What everyone wants to avoid is a repeat of the mass immunization program following the swine flu outbreak at Fort Dix in 1976. After 45 million doses were distributed, the vaccine was found to be associated with increased cases of Guillain-Barré syndrome, which can cause paralysis and sometimes death. Even worse, there wasn't actually a pandemic — the program had been launched in fears that the swine flu virus circulating among recruits at Fort Dix would cause a catastrophic outbreak. In the end, there was no transmission across the U.S., and the vaccination program was canceled.
So there will need to be some sort of mechanism to track and monitor for rare safety events even after the vaccine goes on the market. There is already a program to do so, which is the Vaccine Adverse Event Reporting System, run by the CDC.
While it may be impossible for a phase 3 trial to catch a very rare potential side effect, Offit, of the Children's Hospital of Philadelphia, points out that "it's not a risk-free choice to not get the vaccine, if the virus is still circulating."
He added, "If the data were clear that in 20,000 people it appears to be safe and highly efficacious, then you should get the vaccine, because if you're choosing not to get a vaccine, you're choosing to risk getting a natural infection, which could be fatal."
The Trump administration's Operation Warp Speed has said it "aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021."
Experts I've spoken to have ranged in their optimism about that timeline. The NIH's Mascola said, "If a study is started in the summertime, it's possible that by the end of the year we'll have an answer."
Dr. Luciana Borio, former FDA acting chief scientist and current vice president at In-Q-Tel, a nonprofit strategic investment firm, concurred. "Depending on the results of the clinical trials, I think we might see some vaccine become available before the end of the year, but most people will have to wait for 2021."
Others were more cautious. Orenstein said he thinks there is a "real possibility" that we will have a vaccine by summer next year, "if everything goes well."
Vanderbilt's Schaffner said he prefers to avoid timelines altogether. "We're making the same mistake we made back in 2009 when we developed the H1N1 vaccine. We made the same statements and then it took more time than people anticipated, and when it finally came out, the media all said, 'It's a late vaccine!'
"So we overpromised and underdelivered in 2009, and we haven't learned that lesson. We are overpromising now, and I wish we wouldn't do that. I wish we would just say, 'We're working as hard as we can and we'll get it to you whenever it's finished, but we've got to do it right.' And that would be a much more solid message."
ProPublica deputy managing editor Charles Ornstein wanted to know why experts were wrong when they said U.S. hospitals would be overwhelmed by COVID-19 patients. Here's what he learned, including what hospitals can do before the next wave.
Many of the experts I talked to stressed that they wanted to see the phase 3 trials run to completion, however long they took.
Dr. Brit Trogen, a pediatrics resident at NYU Langone, said she worries about political pressures on developers. "I consider vaccines to be one of the greatest public health achievements of the past few centuries, and I know the consequences of undervaccinating, because I treat kids who are seriously ill with preventable illness," she said. "But I worry that at the first hint of something positive, politicians will swoop in and push for an early release beyond what the science allows."
Some also noted that vaccine hesitancy has been growingin the United States, thanks to a fervent anti-vaccination movement.
Dr. Peter Hotez, a vaccine scientist, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine, said communication that focuses solely on speed "is very tone deaf to the fact that there's an aggressive anti-vax lobby that says that vaccines are rushed and aren't adequately tested for safety."
I brought these concerns to the FDA, as the agency will ultimately be the one to make the call on when there is sufficient data to approve a vaccine.
"We recognize that there are some that are concerned that 'rapid development' means that vaccine development steps are being skipped, but the FDA scientists will not cut corners in order to approve a vaccine," the agency responded. "The FDA will thoroughly evaluate the data submitted in support of a vaccine's safety and effectiveness, and will approve a vaccine for the prevention of COVID-19 only if the FDA determines that it is safe and effective for its intended use."
When I pause to really think about it, I am staggered by what an enormous undertaking is underway around the globe — and what lies ahead — to develop and distribute a COVID-19 vaccine to billions of people. There is so much at stake, both to give the world a vaccine as soon as possible, and also to not make any critical mistakes in the process. As I cheer on all of the developers, I hope that every country's leaders will let science and evidence guide decisions every step of the way.
I asked Zaks, of Moderna, what kind of pressure he felt, and he answered me in two ways. He said: "Every day and every minute counts." And then he told me this — that normally, when he works on vaccines, he never gets to meet the people that he's making the vaccine for. But this pandemic has been different. His future daughter-in-law is a second-year internal medicine resident in New York City, where the coronavirus has hit hard. "This one's personal," he said. "This one cuts close to home."
The prediction from New York Gov. Andrew Cuomo was grim.
In late March, as the number of COVID-19 cases was growing exponentially in the state, Cuomo said New York hospitals might need twice as many beds as they normally have. Otherwise there could be no space to treat patients seriously ill with the new coronavirus.
"We have 53,000 hospital beds available," Cuomo, a Democrat, said at a briefing on March 22. "Right now, the curve suggests we could need 110,000 hospital beds, and that is an obvious problem and that's what we're dealing with."
The governor required all hospitals to submit plans to increase their capacity by at least 50%, with a goal of doubling their bed count. Hospitals converted operating rooms into intensive care units, and at least one replaced the seats in a large auditorium with beds. The state worked with the federal government to open field hospitals around New York City, including a large one at the Jacob K. Javits Convention Center.
But when New York hit its peak in early April, fewer than 19,000 people were hospitalized with COVID-19. Some hospitals ran out of beds and were forced to transfer patients elsewhere. Other hospitals had to care for patients in rooms that had never been used for that purpose before. Supplies, medications and staff ran low. And, as The Wall Street Journal reported on Thursday, many New York hospitals were ill prepared and made a number of serious missteps.
All told, more than 30,000 New York state residents have died of COVID-19. It's a toll worse than any scourge in recent memory and way worse than the flu, but, overall, the health care system didn't run out of beds.
"All of those models were based on assumptions, then we were smacked in the face with reality," said Robyn Gershon, a clinical professor of epidemiology at the NYU School of Global Public Health, who was not involved in the models New York used. "We were working without situational awareness, which is a tenet in disaster preparedness and response. We simply did not have that."
Cuomo's office did not return emails seeking comment, but at a press briefing on April 10, the governor defended the models and those who created them. "In fairness to the experts, nobody has been here before. Nobody. So everyone is trying to figure it out the best they can," he said. "Second, the big variable was, what policies do you put in place? And the bigger variable was, does anybody listen to the policies you put in place?"
So, why were the projections so wrong? And how can political leaders and hospitals learn from the experience in the event there is a second wave of the coronavirus this year? Doctors, hospital officials and public health experts shared their perspectives.
The Models Overstated How Many People Would Need Hospital Care
The models used to calculate the number of people who would need hospitalization were based on assumptions that didn't prove out.
Early data from the U.S. Centers for Disease Control and Prevention suggested that for every person who died of COVID-19, more than 11 would be hospitalized. But that ratio was far too high and decreased markedly over time, said Dr. Christopher J.L. Murray, director of the Institute for Health Metrics and Evaluation at the University of Washington. IHME's earliest models on hospitalizations were based on that CDC data and predicted that many states would quickly run out of hospital beds.
A subsequent model, released in early April, assumed about seven hospitalizations per death, reducing the predicted surge. Currently, Murray said, the ratio is about four hospital admissions per death.
"Initially what was happening and probably what we saw in the CDC data is doctors were admitting anybody they thought had COVID," Murray said. "With time they started admitting only very sick people who needed oxygen or more aggressive care like mechanical ventilation."
A model created by the Harvard Global Health Institute made a different assumption that also turned out to be too high. Data from Wuhan, China, suggested that about 20% of those known to be infected with COVID-19 were hospitalized. Harvard's model, which ProPublica used to build a data visualization, assumed a hospitalization rate in the United States of 19% for those under 65 who were infected and 28.5% for those older than 65.
But in the U.S., that percentage proved much too high. Official hospitalization rates vary dramatically among states, from as low as 6% to more than 20%, according to data gathered from states by The COVID Tracking Project. (States with higher rates may not have an accurate tally of those infected because testing was so limited in the early weeks of the pandemic.) As testing increases and doctors learn how to treat coronavirus patients out of the hospital, the average hospitalization rate continues to drop.
New York state's testing showed that by mid-April, approximately 20% of the adult population in New York City had antibodies to COVID-19. Given the number hospitalized in the city and adjusting for the time needed for the body to produce antibodies, this means that the city's hospitalization rate was closer to 2%, said Dr. Nathaniel Hupert, an associate professor at Weill Cornell Medicine and co-director of the Cornell Institute for Disease and Disaster Preparedness.
Dr. Ashish Jha, director of the Harvard Global Health Institute, and his team also assumed that between 20% and 60% of the population would be infected with COVID-19 over six to 18 months. That was before stay-at-home orders took effect nationwide, which slowed the virus's spread. Outside of New York City, a far lower percentage of the population has been infected. Granted, we're not even six months into the pandemic.
A number of factors go into disease models, including the attack rate (the percentage of the entire population that eventually becomes infected), the symptomatic rate (how many people are going to show symptoms), the hospitalization rate for different age groups, the fraction of those hospitalized that will need intensive care and how much care they will need, as well as how the disease travels through the population over time (what is known as "the shape of the epidemic curve"), Hupert said.
Before mid-March, Hupert's best estimate of the impact of COVID-19 in New York state was that it would lead to a peak hospital occupancy of between 13,800 to 61,000 patients in both regular medical wards and intensive care. He shared his work with state officials.
David Muhlestein, chief strategy and chief research officer at Leavitt Partners, a health care consulting firm, said one takeaway from COVID-19 is that models can't try to predict too far into the future. His firm has created its own projection tool for hospital capacity that looks ahead three weeks, which Muhlestein said is most realistic given the available data.
"If we were held to our very initial projection of what was going to happen, everybody would be very wrong in every direction," he said.
Hospitals Proved Surprisingly Adept at Adding Beds
When calculating whether hospitals would run out of beds, experts used as their baseline the number of beds in use in each hospital, region and state. That makes sense in normal times because hospitals have to meet stringent rules before they are able to add regular beds or intensive care units.
But in the early weeks of the pandemic, state health departments waived many rules and hospitals responded by increasing their capacity, sometimes dramatically. "Just because you only have six ICU beds doesn't mean they will only have six ICU beds next week," Muhlestein said. "They can really ramp that up. That's one of the things we're learning."
Take Northwell Health, a chain of 17 acute-care hospitals in New York. Typically, the system has 4,000 beds, not including maternity beds, neonatal intensive care unit beds and psychiatric beds. The system grew to 6,000 beds within two weeks. At its peak, on April 7, the hospitals had about 5,500 patients, of which 3,425 had COVID-19.
The system erected tents, placed patients in lobbies and conference rooms, and its largest hospital, North Shore University Hospital, removed the chairs from its 300-seat auditorium and replaced them with a unit capable of treating about 50 patients. "We were pulling out all the stops at that point," Senior Vice President Terence Lynam said. "It was unclear if the trend was going to go the other way. We did not end up needing them all."
Northwell went from treating 49 COVID-19 inpatients on March 16 to 3,425 on April 7. "I don't think anybody had a clear handle on what the ceiling was going to be," Lynam said. As of Wednesday, the system was still caring for 367 COVID-19 patients in its hospitals.
As hospitals found ways to expand, government leaders worked with the Army Corps of Engineers to build dozens of field hospitals across the country, such as the one at the Javits Center. According to an analysis of federal spending by NPR, those efforts cost at least $660 million. "But nearly four months into the pandemic, most of these facilities haven't treated a single patient," NPR reported. As they began to come online, stay-at-home orders started producing results, with fewer positive cases and fewer hospitalizations.
Demand for Non-COVID-19 Care Plummeted More Than Expected
Hospitals across the country canceled elective surgeries, from hip replacements to kidney transplants. That greatly reduced the number of non-COVID-19 patients they had to treat. "We generated a lot more capacity by getting rid of elective procedures than any of us thought was possible," Harvard's Jha said.
Northwell canceled elective surgeries on March 16, and over the span of the next week and a half, its hospitals discharged several thousand patients in anticipation of the coming surge. "In retrospect, it was a wise move," Lynam said. "It just ballooned after that. If we had not discharged those patients in time, there would have been a severe bottleneck."
What's more, experts say, it's clear that some patients with true emergencies also stayed home. A recent report from the CDC said that emergency room visits dropped by 42% in the early weeks of the pandemic. In 2019, some 2.1 million people visited ERs each week from late March to late April. This year, that dropped to 1.2 million per week. That was especially true for children, women and people who live in the Northeast.
In New York City, emergency room visits for asthma practically ceased entirely at the peak, Cornell's Hupert said. "You wouldn't imagine that asthma would just disappear," he said. "Why did it go away? ... Nobody has seen anything like that."
Undoubtedly some people experienced heart attacks and strokes and didn't go to the hospital because they were fearful of getting COVID-19. "I didn't expect that," Jha said. A draft research paper available on a preprint server, before it is reviewed and published in an academic journal, found that heart disease deaths in Massachusetts were unchanged in the early weeks of the pandemic compared to the same period in 2019. What that may mean is that those people died at home.
The Coronavirus Attacked Every Region at a Different Pace
Some initial models forecast that COVID-19 would hit different regions in similar ways. That has not been the case. New York was hit hard early; California was not, at least initially.
In recent weeks, hospitals in Montgomery, Alabama, saw a lot of patients. Arizona's health director has told hospitals in the state to "fully activate" their emergency plans in light of a spike in cases there. The Washington Post reported on Tuesday that hospitalizations in at least nine states have been rising since Memorial Day.
Dr. Mark Rupp, medical director of the Department of Infection Control and Epidemiology at the University of Nebraska Medical Center in Omaha, said his region hasn't seen a tidal wave like New York. "What we've seen is a rising tide, a steady increase in the number of cases." Initially that was associated with outbreaks at specific locations like meatpacking and food processing plants and to some degree long-term care facilities.
But since then, "it has just plateaued," he said. "That has me concerned. This is a time when I feel like we should be working as hard as we can to push these numbers as low as possible."
Rupp's hospital has been caring for 50 to 60 COVID-19 patients on any given day. The hospital has started to perform surgeries and procedures that had been on hold because "elective cases stay elective for only so long."
The hospital's general medical/surgical beds are 70% to 80% filled, and its ICU beds are 80% to 90% full. "We don't have a big cushion."
Even in New York City, the virus hit boroughs differently. Queens and the Bronx were hard hit; Manhattan, Brooklyn and Staten Island less so. "Maybe we can't even model a city as big as New York," Hupert said. "Each neighborhood seemed to have a different type of outbreak."
That needs further study but could be attributable to both social and demographic conditions and the type of jobs residents of the neighborhoods had, among other factors.
What We Can Learn From Coronavirus "Round One"
While hospitals were able to add beds more quickly than experts realized they could, some other resources were harder to come by. Masks, gowns and other personal protective equipment were tough to get. So were ventilators. Anesthesia agents and dialysis medications were in short supply. And every additional bed meant the need for more doctors, nurses and respiratory therapists.
In early February, before any cases were discovered in New York, Northwell purchased $5 million in PPE, ventilators and lab supplies just in case, Lynam said. "It turned out to be a wise move," he said. "What's clear is that you can never have enough."
Northwell has spent $42 million on PPE alone. "We were going through 10,000 N95 masks a day, just a crazy amount," he said. "One of the lessons learned is you have to stockpile the PPE. There's got to be a better procurement process in place."
If there's one thing the system could have done differently, Lynam said, it's bringing in more temporary nurses earlier. Northwell brought in 500 nurses from staffing agencies. "They came in a week later than they should have."
Dr. Robert Wachter, chair of the department of medicine at the University of California, San Francisco, agreed. "I've helped run services in hospitals for 25 years," he said. "I've probably given two minutes of thought to the notions of supply chains and PPE. You realize that is absolutely central to your preparedness. That's a lesson."
Experts and hospital leaders agree that everyone can do better if another wave hits. Here's what that entails:
Having testing readily available, as it now is, to more quickly spot a resurgence of the virus.
Stocking up now on PPE and other supplies. "We definitely have to stockpile PPE by the fall," Gershon of NYU said. "We have to. … [Hospitals and health departments] have to really get those contracts nailed down now. They should have been doing this, of course, all the time, but no one expected this kind of event."
Being able to quickly move personnel and equipment from one hot spot to the next.
Planning for how to care for those with other medical ailments but who are scared of contracting COVID-19. "We have to have some sort of a mechanism by which we can offer people assurance that if they come in, they won't get sick," Jha said. "We can't repeat in the fall what we just did in the spring. It's terrible for hospitals. It's terrible for patients."
Providing mental health resources for front-line caregivers who have been deeply affected by their work. The intensity of the work, combined with watching patients suffer and die alone, was immensely taxing.
Coming up with ways to allow visitors in the hospital. Wachter said the visitor bans in place at many hospitals, though well intentioned, may have backfired. "When all hell was breaking loose and we were just doing the best we could in the face of a tsunami, it was reasonable to just keep everybody out," he said. "We didn't fully understand how important that was for patients, how much it might be contributing to some people not coming in for care when they really should have."
Lynam of Northwell said he's worried about what lies ahead. "You look back on the 1918 Spanish flu and the majority of victims from that died in the second wave. … We don't know what's coming on the second wave. There may be some folks who say you're paranoid, but you've got to be prepared for the worst."
Gov. Michelle Lujan Grisham cited "significant, awful allegations" in a ProPublica and New Mexico In Depth story on a hospital where clinicians said pregnant Native women were singled out for COVID-19 testing and separated from newborns after delivery.
This article was first published on Sunday, June 14, 2020 in ProPublica.
New Mexico Gov. Michelle Lujan Grisham announced on Twitter Saturday that state officials would investigate allegations of racial profiling of pregnant Native American women at a top hospital in Albuquerque.
Lujan Grisham was reacting to a story published Saturday by New Mexico In Depth and ProPublica revealing that Lovelace Women’s Hospital had a secret policy for screening Native American women for coronavirus based on their appearance and home ZIP code, according to several clinicians who work there.
Described as racial profiling by medical ethicists, the policy resulted in some Native American women being separated from their newborns at birth as hospital staff waited for test results, according to the clinicians.
“These are significant, awful allegations and, if true, a disgusting and unforgivable violation of patient rights,” Lujan Grisham, a Democrat, wrote. “The state of New Mexico is investigating whether this constitutes a CMS violation and will unequivocally hold this hospital accountable.”
CMS, or the U.S. Centers for Medicare and Medicaid Services, regulates hospitals to ensure that all patients have access to medical care.
Described as racial profiling by medical ethicists, the policy resulted in some Native American women being separated from their newborns at birth as hospital staff waited for test results, according to the clinicians.
“These are significant, awful allegations and, if true, a disgusting and unforgivable violation of patient rights,” Lujan Grisham, a Democrat, wrote. “The state of New Mexico is investigating whether this constitutes a CMS violation and will unequivocally hold this hospital accountable.”
CMS, or the U.S. Centers for Medicare and Medicaid Services, regulates hospitals to ensure that all patients have access to medical care.
State Auditor Brian S. Colón also weighed in, with a Facebook post commenting that Lovelace “has some additional explaining to do.”
A Lovelace spokeswoman did not immediately respond to a voice message and email Saturday. In previous statements, Lovelace acknowledged screening patients by geographic area, but it said that such practices followed guidelines from the U.S. Centers for Disease Control and Prevention. It was not immediately clear whether the policy described by clinicians remained in place on Saturday.
The CDC doesn’t mention geography in its COVID-19 guidelines for pregnant women. It specifies that pregnant patients should be treated as people under investigation for COVID-19 only if they exhibit symptoms or have had recent high-risk contact with COVID-19 patients.
According to several Lovelace clinicians, when pregnant women showed up at the hospital who appeared to be Native American, staff members were instructed to compare the expectant mother’s home ZIP code against a list of Indian reservation ZIP codes maintained by the hospital, known informally as the “Pueblos List,” a reference to New Mexico’s Pueblo Indian tribes. If the pregnant woman’s ZIP code matched one on the list, she was designated as a “person under investigation” for COVID-19 and tested even if she did not have symptoms, the clinicians said.
Several Native American tribes in New Mexico have been hit hard by the coronavirus, recording some of the highest per capita rates of infection in the nation. But not all of the ZIP codes on the list are home to tribes with high prevalence of the disease.
Lovelace did not use rapid COVID-19 tests, so it took up to three days for results to come back. During that time, the hospital separated some asymptomatic mothers from their newborns as part of an effort to prevent transmission of the virus from mother to child. Other Albuquerque hospitals are using rapid tests and do not separate Native American mothers from newborn children.
Such separations deprive infants of close, immediate contact with their mothers that doctors recommend.
“We had no knowledge of this practice happening,” Tripp Stelnicki, Lujan Grisham’s communications director, said Saturday.
The state Health Department has contacted CMS to determine how to proceed, Stelnicki said.
“The intent is to find out what ... is going on,” Stelnicki said. “And if indeed, if this has happened, it is extremely disturbing, and to rectify the position if there were CMS violations, those will be pursued.”
Pregnant Native American women were singled out for COVID-19 testing based on their race and ZIP code, clinicians say. While awaiting results, some mothers were separated from their newborns, depriving them of the immediate contact doctors recommend.
This article was first published on Saturday, June 13, 2020 in ProPublica.
ALBUQUERQUE, N.M. — A prominent women’s hospital here has separated some Native American women from their newly born babies, the result of a practice designed to stop the spread of COVID-19 that clinicians and health care ethicists described as racial profiling.
Lovelace Women’s Hospital in Albuquerque implemented a secretive policy in recent months to conduct special coronavirus screenings for pregnant women, based on whether they appeared to be Native American, even if they had no symptoms or were otherwise at low risk for the disease, according to clinicians.
The hospital screens all arriving patients for COVID-19 with temperature checks and asks them whether they’ve been in contact with people who have the illness. But for soon-to-be moms who appeared to be Native American, there was an additional step, according to clinicians interviewed on the condition they not be named.
Hospital staff would compare the expectant mother’s ZIP code against a list of Indian reservation ZIP codes maintained by the hospital, known informally as the “Pueblos List,” a reference to New Mexico’s Pueblo Indian tribes. If the pregnant woman’s ZIP code matched one on the list, she was designated as a “person under investigation” for COVID-19, the clinicians said.
Lovelace does not use rapid COVID-19 tests, and babies were sometimes born before asymptomatic Native American mothers’ test results came back from the lab, a process that can take up to three days. As a result, the hospital separated Native American newborns from their asymptomatic mothers in at least a half-dozen cases, one clinician said.
Such separations deprive infants of close, immediate contact with their mothers that doctors recommend.
“I believe this policy is racial profiling,” one clinician said. “We seem to be applying a standard to Native Americans that isn’t applied to everybody else. We seem to be specifically picking out patients from Native communities as at-risk whether or not there are outbreaks at their specific pueblo or reservation.”
The Navajo Nation and several Pueblo tribes in New Mexico have recorded some of the highest per capita rates of COVID-19 infection in the nation. In response to the pandemic, the state has designated several counties as hot spots, including some that are home to tribes with large numbers of cases. But 10 of the ZIP codes on the Lovelace Pueblos List reviewed by New Mexico In Depth and ProPublica do not fall within those hot spot counties, nor do all tribes within those ZIP codes have a high rate of infection.
A Lovelace spokeswoman acknowledged screening patients by geography, but she would not confirm or deny the existence of a policy based on ZIP codes as described by staff. Lovelace, whose owner is Nashville, Tennessee-based Ardent Health Services, is Albuquerque’s largest privately owned hospital system.
“Part of our screening process includes identifying and testing patients who reside in high-risk areas such as nursing homes and regional hot spots of COVID-19 cases as recommended” by the Centers for Disease Control and Prevention, Lovelace spokeswoman Whitney Marquez wrote in a May 21 email.
But CDC guidelines for evaluating COVID-19 risk among pregnant patients do not mention geography or ZIP code of residence. The guidelines instead state that only pregnant patients with COVID-19 symptoms or recent high-risk contacts with COVID-19 patients should be treated as suspected cases.
“Regardless of pending test results, pregnant individuals who are asymptomatic at the time of admission and have no history of high-risk contact should not be considered to be suspected cases,” the CDC guidelines note.
In a follow-up email, Marquez said Lovelace’s residential geography screening applied to all patients: “Any patient admitted to the hospital for any reason from a designated hot spot region is tested for COVID-19 as a PUI (person under investigation), per CDC guidance.”
Marquez’s claim was disputed by several clinicians who work in the hospital. Only ZIP codes with significant populations of Native Americans appeared on the list. Patients who did not appear to be Native American were not subject to further screening based on the ZIP code list, they said.
The two other large hospitals in Albuquerque said they did not have a policy like the one described by clinicians at Lovelace. Mothers are not determined to be suspected COVID-19 cases based only on their home ZIP code or their appearance, officials at Presbyterian Hospital and the University of New Mexico Hospital said. Nor are asymptomatic mothers’ newborns separated for isolation pending test results at those other hospitals.
At Lovelace, only women who appear to be Native American were singled out for the additional examination, even if they showed no symptoms and had not been in contact with a person who has tested positive for the illness, clinicians said.
“This isn’t about where you live or if you live in a hot spot — it’s about whether someone thinks you look Native,” a clinician explained. “The only people for whom we’ve been told to check ZIP codes are patients who appear to be Native.”
Health care ethicists said the practice described by the clinicians raises troubling questions about bias, trust and informed patient consent.
Saskia Popescu, a senior infection prevention epidemiologist at George Mason University in Fairfax, Virginia, said such policy decisions wouldn’t make sense from an infection control or epidemiology perspective, and they could create or exacerbate trust issues toward health care among Native American patients.
“There is a lot of room for error and a lot of assumptions,” she noted. “You’re assuming their mailing address is where they live, and they’ve been exposed or not exposed based on where they live. It doesn’t match public health guidance.”
Popescu said she understood why the hospital might place someone under investigation if they came from high-risk settings like nursing homes, but she questioned how a case could be made for doing so based on a home ZIP code.
“I don’t really know how well you can make the case that if a mom is asymptomatic, if she is reporting no known exposures to sick people, how you can make the case for keeping that baby in the NICU, separated,” Popescu said.
The “Pueblos” List
A copy of the Lovelace list reviewed by New Mexico In Depth and ProPublica contains names of tribes next to each of 22 associated ZIP codes. Native Americans have a much higher COVID-19 rate overall than other populations in New Mexico, but most of the tribes on the list have a low prevalence of the illness. For instance, the ZIP code for Cochiti Pueblo had recorded zero cases as of Tuesday; the ZIP code for Picuris Pueblo had just one. An additional eight ZIP codes had 7 or fewer cases.
An internal communication reviewed by New Mexico In Depth and ProPublica suggests the intent was to include all Indian reservations on the ZIP code list. But if so, the list is inexplicably incomplete.
All 19 New Mexico Indian Pueblos and the Mescalero Apache tribe are named next to a ZIP code on the list, and the Navajo Nation is named next to five ZIP codes. (Several Pueblo Indian tribes share some ZIP codes.) But missing from the list are the Jicarilla Apache tribe and three outlying Navajo communities: To’hajiilee, Ramah and Alamo. Also missing are numerous ZIP codes in the northwest part of the state with significant Native populations — and COVID-19 outbreaks.
Marquez did not provide a list of “designated hot spot” regions or ZIP codes despite repeated requests, other than stating that New Mexico hot spot regions “have been determined by the New Mexico Department of Health.”
But the state defines COVID-19 geographic hot spots by county, not ZIP codes, spokesman David Morgan wrote in an email.
“Hospitals have the latitude to decide on who to test, but no testing decisions should be made arbitrarily solely on the basis of race or ethnicity,” State Epidemiologist Michael Landen wrote in an email Thursday.
Referring to a map on the state Health Department’s online COVID-19 dashboard, Human Services Department spokeswoman Jodi McGinnis Porter listed the counties of San Juan, McKinley, Sandoval, Bernalillo and Doña Ana as state-designated hot spots.
Twelve of the 22 ZIP codes, which are home to 14 tribes on the list, have very few positive COVID-19 cases, according to publicly available Health Department data. Those ZIP codes are shaded green, or have no color, on the state data portal, signifying they have the lowest number of cases compared with other areas.
In other words, the Pueblos List contains low-risk ZIP code areas that include particular tribes but do not include other ZIP codes falling within counties deemed to be COVID-19 hot spots by the state — even those that contain large swaths of the heavily hit Navajo Nation.
Separating Babies
Usually, Lovelace officials announce new policies by emailing links to staff. But that was not done in this case. Instead, supervisors read the policy aloud at the beginning of each shift, clinicians said.
The verbal readings didn’t mention that Native American mothers had to provide informed consent to be tested or separated from their newborn, a clinician said. That ambiguity appears to have caused confusion among staff.
One clinician said that Native American mothers were given an opportunity to decline separation from their infants.
But another clinician said some staff did not know patients had an option to do so for several weeks in April and May. “I don’t believe that patients were given an opportunity to decline testing or separation from their babies,” that clinician said. “This is a violation of informed consent, which is a foundation of modern health care.”
Marquez, the hospital spokeswoman, disputed the claim. She said that Lovelace provides all patients suspected or confirmed of having COVID-19 with information about the risks of remaining with their newborns. “Some patient[s] opt to keep their baby with them,” she said.
At least part of the issue lies in the type of tests done to detect COVID-19. Several Albuquerque hospitals, including Presbyterian and the University of New Mexico, use new rapid COVID-19 tests that yield results as quickly as two hours.
Lovelace, however, uses slower tests. Marquez would not explain why Lovelace did not deploy more rapid tests.
Nicolle L. Gonzales, a Navajo nurse midwife who worked at Lovelace for two years, first heard about the ZIP code policy from a colleague at the hospital last month.
Gonzales, who founded and directs the Changing Woman Initiative, a Native American women-led health collaborative in Santa Fe, New Mexico, said informed consent is an important concern for Native American patients
“You know, if you’re a Native person in an all-white setting, how do you speak up for yourself?” she asked. “There is no way to measure whether you’re being racially profiled or racially excluded from a norm [of treatment] that’s happening or not happening with others.”
Several Lovelace clinicians voiced concern about newborn separations and delayed breastfeeding, which can reduce the odds of successful breastfeeding later on, denying health benefits to mothers and their babies. For babies, breastfeeding can benefit immune system and brain development. Mothers who breastfeed have lower risks of breast cancer.
“Unless there is a life-threatening issue, we do not take babies from their moms,” a clinician explained. “It is standard practice and policy for babies to be immediately put on the mother, before and during the cutting of the umbilical cord, and to leave them there for at least an hour.”
For some health care ethicists, the policy described by the Lovelace clinicians recalled the federal government’s long, troubling history of separating Native American infants from their mothers. For others, it appeared uncomfortably similar to the disparate treatments of minorities in previous epidemics.
“This raises the specter of the HIV/AIDS pandemic in the 1980s,” said Barbara Gurr, associate professor of women’s, gender and sexuality studies at University of Connecticut and author of “Reproductive Justice: The Politics of Healthcare for Native American Women.” Gurr recalled a fear-driven bias against Haitian immigrants and gay men as HIV/AIDS spread. “Certain people were understood to be the bearers of the disease, in this kind of contaminating way, right? I think we’re running the risk of doing it again in the COVID pandemic.”
Ethicists also worried about the lingering effects of a policy based on ZIP codes. It could deter Native Americans from seeking hospital obstetric care, said Ann Mongoven, associate director of health care ethics at the Markkula Center for Applied Ethics at Santa Clara University in California.
“There’s a real concern that this policy could discourage people who absolutely should have hospital births,” she said.
Bryant Furlow is a reporter for New Mexico In Depth.
TeamHealth, a medical staffing firm owned by private-equity giant Blackstone, charges multiples more than the cost of ER care. All the money left over after covering costs goes to the company, not the doctors who treated the patients.
This article was first published on Friday, June 12, 2020 in ProPublica.
In 2017, TeamHealth, the nation's largest staffing firm for ER doctors, sued a small insurance company in Texas over a few million dollars of disputed bills.
Over 2 1/2 years of litigation, the case has provided a rare look inside TeamHealth's own operations at a time when the company, owned by private-equity giant Blackstone, is under scrutiny for soaking patients with surprise medical bills and cutting doctors' pay amid the coronavirus pandemic.
Hundreds of pages of tax returns, depositions and other filings in state court in Houston show how TeamHealth marks up medical bills in order to boost profits for investors. (Some of the court records were marked confidential but were available for download on the public docket; they were subsequently sealed.)
TeamHealth declined to provide an interview with any of its executives. In a statement for this story, the company says it's fighting for doctors against insurance companies that are trying to underpay: "We work hard to negotiate with insurance companies on behalf of patients even as they unilaterally cancel contracts and attempt to drive physician compensation downward."
But the Texas court records contradict TeamHealth's claims that the point of its aggressive pricing is to protect doctors' pay. In fact, none of the additional money that TeamHealth wrings out of a bill goes back to the doctor who treated the patient.
Instead, the court records show, all the profit goes to TeamHealth.
Anatomy of an ER Bill
Two TeamHealth affiliates in Texas billed 7.7 times more than their actual costs of paying for clinicians and support services. The bulk of the charges were discounted or written off. About 10% of the money actually collected went to corporate profits.
"These companies put a white coat on and cloak themselves in the goodwill we rightly have toward medical professionals, but in practice, they behave like almost any other private equity-backed firm: Their desire is to make profit," said Zack Cooper, a Yale professor of health policy and economics who has researched TeamHealth's billing practices and isn't involved in the Texas lawsuit.
"In the market for emergency medicine, where patients can't choose where they go in advance of care, there's a real opportunity to take advantage of patients, and I think we're seeing that that's almost precisely what TeamHealth is doing, and it's wildly lucrative for the firm itself and its private equity investors."
Some of TeamHealth's own physicians say they're uncomfortable with the company's business practices.
"As an emergency medicine physician, I have absolutely no idea to whom or how much is billed in my name. I have no idea what is collected in my name," said a doctor working for TeamHealth who isn't involved in the Texas lawsuit and spoke to ProPublica on the condition of anonymity because the company prohibits its doctors from speaking publicly without permission.
"This is not what I signed up for and this isn't what most other ER docs signed up for. I went into medicine to lessen suffering, but as I understand more clearly my role as an employee of TeamHealth, I realize that I'm unintentionally worsening some patients' suffering."
Most ER doctors aren't employees of the hospital where they work. Historically they belonged to doctors' practice groups. In recent years, wealthy private investors have bought out those practice groups and consolidated them into massive nationwide staffing firms like TeamHealth and its largest competitor, KKR-owned Envision Healthcare.
These takeovers have affected patients, too, because the groups have gotten into payment disputes with their insurers. As a result, patients can receive huge medical bills even when they pick a hospital within their insurance plan's network, because the individual doctor working for a contractor like TeamHealth could be out of network. This practice, known as surprise billing, caught the attention of lawmakers who have spent months working on legislation.
TeamHealth said surprise bills are "rare and unintended," but with millions of patients, it has happened tens of thousands of times. The company has called surprise billing a "source of contracting negotiating leverage" to demand higher payments from insurers.
"Underneath this are patients who may well be charged outrageous amounts of money, but that's just not a core consideration," said Joshua Sharfstein, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. "The situation a lot of patients feel like they're in is they're collateral in this financial tug of war."
TeamHealth and Envision Healthcare have poured millions into political ads attacking surprise billing legislation. The companies have said they want to settle out-of-network bills through arbitration instead of using average local rates, as some lawmakers have proposed.
As an alternative to going after patients themselves, TeamHealth said it sues insurers to demand higher payments for out-of-network charges. The company has filed 38 such lawsuits since 2018.
In the Texas case, two TeamHealth affiliates that provide doctors and nurses to emergency rooms in the Houston and El Paso areas sued a small insurance company called Molina Healthcare. TeamHealth identified almost 5,000 out-of-network claims in 2016 and 2017 for which it billed $6.6 million and Molina paid $760,000. TeamHealth sent a letter demanding that Molina pay $2.3 million. Molina's lawyers viewed this as an admission that the original bill was far higher than even TeamHealth thought was fair.
The actual costs of medical services are not a factor in setting TeamHealth's prices, according to the deposition of Kent Bristow, a TeamHealth executive in charge of revenue. At some locations, TeamHealth's prices were higher than those of 95% of other providers and eight or nine times more than what Medicare would pay, according to Bristow's deposition.
Most of the two TeamHealth affiliates' charges were never actually collected, according to their tax returns and a deposition of the accountant who prepared them. For the years 2016 and 2017, the two affiliates billed a combined $1.9 billion, the tax returns show. But $1.1 billion, or 58%, was discounted according to negotiated deals with insurers. An additional $528 million was written off as bad debt that would never get repaid. So the combined revenue that the two affiliates actually received across the two years was $274.5 million, or about 14% of the amount initially billed, according to the tax returns.
The amount that TeamHealth charges doesn't determine how much TeamHealth pays its doctors who perform those services, the company's chief financial officer, David Jones, said in an October 2019 deposition. Instead, the doctors are paid a base compensation plus an incentive tied to how much work they do (which is not the same as the price billed for their services). For the two TeamHealth affiliates in the Molina case in 2016 and 2017, the company paid doctors a total of $170.5 million, or 62% of the net revenue, according to the tax returns. Other health care providers such as nurse practitioners and scribes received another $48.4 million.
Multiple private-equity-backed staffing companies have cut hours for thousands of emergency room doctors, physician assistants and nurse practitioners. That means there are fewer medical workers at a time in hospitals and they are receiving less pay.
The administrative services that TeamHealth provides — such as billing, printing and malpractice insurance — added up to $29.5 million, according to the tax returns.
After covering all those expenses, the amount of money left over — commonly called profit — was $26.1 million, about 10% of the two affiliates' net revenue in 2016 and 2017. (The accounting method that TeamHealth uses for its tax returns is different from how it prepares financial statements regulated by the Securities and Exchange Commission. Under the latter method, the tax returns note a total of $36.8 million for the two affiliates in 2016 and 2017. Because of these accounting variations, it's impossible to compare the figures on the TeamHealth affiliates' tax returns to profits reported by publicly traded health care companies.)
The TeamHealth executive in charge of the two affiliates said he assumed the profit would be shared with the doctors who did the work. "It would most likely go back to the providers," the executive, Lance Williams, said in a deposition. Under further questioning, he admitted, "Yeah, I'm not sure."
In fact, the entire leftover $26.1 million went to TeamHealth's "management fee." The management fee is not a fixed rate but rather everything that remains after covering costs, regardless of the amount, according to the CFO's deposition. "If the revenues exceed the expenses, that is essentially the management fee," Jones said.
In other words, out of the $1.6 billion that was originally billed but not collected, any additional dollar that TeamHealth managed to recover would be passed through to the corporate parent. The doctors would not see it.
Jones said doctors benefit from increasing collections because their incentive-based pay is adjusted over time. In addition, Bristow said the management fee is not the same as profit because there may be additional expenses at the corporate level.
"The economic benefits created by these practices, any profit, if you will, ultimately flows up to the TeamHealth entity," Ron Luke, a health economics expert hired by Molina, said in a deposition.
To establish this business model, TeamHealth had to find a way to deal with long-standing state laws that were specifically designed to protect the medical profession from becoming beholden to profit motives. These laws, known as the corporate practice of medicine doctrine, require doctors to work for themselves or other doctors, not lay people or corporations like TeamHealth. Court records in the Molina case show how TeamHealth's lawyers use shell entities to avoid directly employing doctors.
"TeamHealth monetizes this process by unilaterally setting charges and then billing patients and payors for those amounts and retaining all of the profits of the enterprise," Robert McNamara, a former president of the American Academy of Emergency Medicine, wrote in a memo as an expert witness against TeamHealth in the lawsuit. "The fees generated, billed, and retained by TeamHealth reflect the type of overt commercialization of the medical profession that the prohibition on the [corporate practice of medicine] is designed to prevent."
TeamHealth said its business arrangements comply with all laws and no court or agency has ever found otherwise. "TeamHealth's clinicians are supported by a world-class operating team that provides them with comprehensive practice management services that allow our clinicians to focus on the practice of medicine," the company said. Envision Healthcare also said it follows all local, state and federal laws and regulations.
State laws against the corporate practice of medicine date as far back as the 19th century, as doctors strove to distinguish themselves from quacks and snake oil salesmen. According to the American Medical Association, the laws are meant to prevent profit motives from influencing medical judgments — a recognition that corporations' devotion to shareholder value shouldn't mix with doctors' Hippocratic oath.
Another way to think about it is: Practicing medicine requires a license, and only a real human being can possibly have the education, training and character qualifications that licensing boards require.
Courts have scrutinized these arrangements for decades. No judge has ever ruled that TeamHealth or Envision Healthcare specifically violate state licensing rules. But such allegations have repeatedly cropped up in lawsuits involving the companies, some of which settled favorably to the other side, according to McNamara, who was consulted on many of the cases.
After the Blackstone Group acquired one of the nation's largest physician staffing firms in 2017, low-income patients faced far more aggressive debt collection lawsuits. They only stopped after ProPublica and MLK50 asked about it.
TeamHealth and Envision have themselves acknowledged that they operate on questionable legal ground. During periods when the companies were publicly traded, their investor disclosures highlighted the controversy surrounding their compliance with state licensing regimes. TeamHealth and Envision said they believed their business models were legal but recognized that prosecutors, regulators and judges could conclude otherwise. TeamHealth specifically cited "laws prohibiting general business corporations, such as us, from practicing medicine."
"While we believe that our operations and arrangements comply substantially with existing applicable laws relating to the corporate practice of medicine and fee splitting, we cannot assure you that our existing contractual arrangements, including restrictive covenant agreements with physicians, professional corporations and hospitals, will not be successfully challenged in certain states as unenforceable or as constituting the unlicensed practice of medicine or prohibited fee splitting," the company said in its 2015 annual report. "In this event, we could be subject to adverse judicial or administrative interpretations or to civil or criminal penalties, our contracts could be found to be legally invalid and unenforceable or we could be required to restructure our contractual arrangements with our affiliated provider groups."
TeamHealth says the laws are outdated and unnecessary — as one of the company's senior lawyers called it in a deposition, "this arcane law we call the corporate practice of medicine that nobody needs."
Not all states have such laws. In Florida, for instance, TeamHealth employs doctors directly. In states that have laws against the corporate practice of medicine, TeamHealth has a workaround depending on the specific requirements in that state. Here's how it works for the affiliates involved in the Molina litigation, just two out of hundreds of equivalent arrangements around the country.
Doctors working for TeamHealth are technically independent contractors to a "professional association," or P.A. In order to comply with Texas law, the professional association is owned by a licensed physician. The professional association then contracts with TeamHealth subsidiaries to provide administrative services — such as billing, payroll and malpractice insurance — in exchange for payment.
These professional associations, however, are hardly independent. They're "owned" by an executive at TeamHealth, and the company has the power to remove and replace him at any time. For the two professional associations involved in the Molina case, when a new executive took over as "owner" in 2019, he said in a deposition that he couldn't remember how he "bought" the entities or if he ever paid anyone the $2 nominal price of their shares.
"Everything about your right to own, operate, and manage ACS and EST [the two professional associations] is dependent upon you staying in the good graces of the TeamHealth organization, correct?" Molina's lawyer asked in the deposition.
"Correct," the owner/executive, Lance Williams, said.
"And if you were fired for any reason, you would lose ownership of ACS and EST, lose the right to manage ACS and EST, correct?"
"Correct."
Williams also said there's no "black and white" separation between clinical and financial issues.
In sum, the contract between TeamHealth and the professional associations gives investors more control of the business than doctors, according to Chuck Pine, a financial investigator who specializes in examining shell companies to determine the real beneficial owners. Pine isn't involved in the Molina litigation.
Molina's lawyers called the arrangement "a sham to permit TeamHealth to unlawfully practice medicine by allowing it to in effect employ physicians in violation of state law."
TeamHealth countered that whether or not Molina's claims are right, they aren't enforceable through private litigation; only the state's attorney general could prosecute a corporation for practicing medicine without a license.
The judge rejected Molina's claims in an order that didn't explain her rationale. Other parts of the case are still pending.
TeamHealth has used the same argument to defeat other lawsuits. It puts opponents in a Catch-22: State licensing boards have no control over a corporation that might be practicing medicine without a license because the boards don't license corporations. The boards could theoretically punish the "owners" of the professional associations, but those doctors are not always licensed in the same state as the practice, and TeamHealth could always replace them with someone else.
The Texas attorney general's office didn't respond to requests for comment. McNamara said he's brought several cases to the attention of various state attorneys general, to no avail.
In scrambling to buy protective equipment for the coronavirus pandemic, federal agencies purchased up to $11 million worth of Chinese-made masks, often with little attention to manufacturing details or rapidly evolving regulatory guidance about safety or quality, a ProPublica review shows.
Some agencies cannot say who made their masks at a time when thousands of foreign-made respirators appeared on the market, some falsely claiming approval or certification by the Food and Drug Administration. Some agencies bought the masks, known as KN95s, from companies that share a U.S. representative with another firm recently accused of fraud by the Justice Department.
The contracts reflect the intense pressure federal agencies were under to procure protective equipment as the pandemic surfaced and rapidly spread in the U.S. Now, some experts worry that the products could remain in circulation long past the crisis and be used by unsuspecting federal employees who believe they have legitimate respirator masks.
Agencies have relaxed procurement standards, including granting many contracts without competitive bidding, and have been tripped up by shifting FDA standards, the flood of foreign companies entering the U.S. market and a limited domestic supply of respirators made for medical use.
"I'm so glad we didn't get involved in this KN95 market," said Andy Mitchell, a vice president at Mallory Safety and Supply, which supplies N95 masks. "This isn't right what's happening here."
ProPublica reported last month that the Indian Health Service had purchased $3 million of Chinese-made respirator masks from a company started by a former White House official, and that the masks did not meet FDA standards. A House of Representatives committee plansto hold a hearing on Thursday examining the IHS' response to the COVID-19 pandemic.
In scrambling to buy protective equipment for the coronavirus pandemic, federal agencies purchased up to $11 million worth of Chinese-made masks, often with little attention to manufacturing details or rapidly evolving regulatory guidance about safety or quality, a ProPublica review shows.
Some agencies cannot say who made their masks at a time when thousands of foreign-made respirators appeared on the market, some falsely claiming approval or certification by the Food and Drug Administration. Some agencies bought the masks, known as KN95s, from companies that share a U.S. representative with another firm recently accused of fraud by the Justice Department.
The contracts reflect the intense pressure federal agencies were under to procure protective equipment as the pandemic surfaced and rapidly spread in the U.S. Now, some experts worry that the products could remain in circulation long past the crisis and be used by unsuspecting federal employees who believe they have legitimate respirator masks.
Agencies have relaxed procurement standards, including granting many contracts without competitive bidding, and have been tripped up by shifting FDA standards, the flood of foreign companies entering the U.S. market and a limited domestic supply of respirators made for medical use.
"I'm so glad we didn't get involved in this KN95 market," said Andy Mitchell, a vice president at Mallory Safety and Supply, which supplies N95 masks. "This isn't right what's happening here."
ProPublica reported last month that the Indian Health Service had purchased $3 million of Chinese-made respirator masks from a company started by a former White House official, and that the masks did not meet FDA standards. A House of Representatives committeeplans to hold a hearing on Thursday examining the IHS' response to the COVID-19 pandemic.
ProPublica reviewed 21 contracts awarded by 11 federal agencies that specifically mentioned procuring KN95 masks, a Chinese version of N95 respirator masks. Five agencies — the Bureau of Prisons, the Department of Veterans Affairs, the U.S. Marshals Service, the U.S. Mint and the U.S. Forest Service — could not say who manufactured their masks or did not respond to questions. The total spent on the 21 contracts was more than $11 million, but some of the deals also involved other items such as ear loop face masks and hand sanitizer.
Foreign-made masks have come under increasing scrutiny from federal regulators. The FDA issued an emergency use authorization for some Chinese-made masks in health care settings in April, but it narrowed the authorization after some masks were found to let through far more particles than advertised.
In many cases, the agencies buying the masks are not directly involved in health care provision, and are thus beyond the scope of the FDA authorization, although the Indian Health Service and the National Institutes of Health were among the purchasers. Some agencies told ProPublica they would use the masks they purchased only in nonmedical settings, a recognition of the lesser protection they may provide.
But experts said the purchase of such products at all still poses a risk to employees. Dr. Meghan Dierks, a Harvard Medical School professor who previously worked at the FDA on medical device shortage issues, said she is concerned about "all of these potentially inferior products remaining in circulation, remaining on shelves" after the current crisis passes, whether used in medical or nonmedical settings.
"If you're in charge of procuring a product that you expect to confer some level of safety or protection to your workers, there's responsibility there for knowing what's the basic performance criteria and what's the regulatory authority in the United States that monitors this," Dierks said.
The FDA tightened its April emergency rules a month later, after testing by the Centers for Disease Control and Prevention revealed that some Chinese masks let in too many fine particles. Dozens of Chinese manufacturers that had initially appeared on an approved FDA list were removed, tripping up buyers who had purchased masks just weeks earlier.
Dr. Suzanne Schwartz, deputy director of the Office of Strategic Partnerships and Technology Innovation at the FDA's Center for Devices and Radiological Health, said the agency has "encouraged importers and distributors to do their own due diligence and take the appropriate steps to verify the product's authenticity prior to importing, particularly those products not authorized by the FDA."
Typically, the FDA moves slowly when issuing rules and regulations, but it quickened its pace during the pandemic, said Michael Abrams, a co-founder of Numerof & Associates, which advises hospitals, pharmaceutical companies, financial institutions and others on health care issues.
"They've been forced to make decisions that they sometimes need to go back on," he said. "Certainly that makes it more difficult for anyone who's relying on what these regulatory entities have to say."
That includes the rest of the federal government. On May 1, the Department of the Interior purchased $114,400 worth of KN95 masks from Red River Resources LLC, a California vendor. The manufacturer was Guangdong ZhiZhen Biological Medicine Co. Ltd., according to the agency.
"At the time of purchase, the respirators were on the list of approved products," Andrea Antunes, an Interior spokeswoman, wrote in an email. "Subsequently, they were removed from the approved list and will not be purchased again."
Antunes did not respond to questions about what the agency would do with the purchased masks.
The website of Guangdong ZhiZhen Biological Medicine displays a mask it labeled "FDA approved FFP2 KN95 Mask." Phone calls and emails sent to CCTC Service Inc., the company's U.S.-based agent, were not returned.
CCTC, based in Delaware, is named as the representative for nearly 1,600 devices listed with the FDA this year, including KN95 masks manufactured by two firms used by Zach Fuentes, a former White House deputy chief of staff, to fulfill the contract with the Indian Health Service.
In a federal court complaint filed June 5 against another Chinese mask manufacturer, King Year Printing and Packaging Co. Ltd., by the Justice Department, an FDA special agent said that there is "probable cause to believe CCTC is a fictitious corporation." FDA records list a residential address for the company, the complaint said, and the house's occupant and owners said they had no knowledge of or connection to CCTC. The Wall Street Journal first reported the federal complaint against King Year.
In the complaint, the government alleges that King Year falsely labeled its respirators with the logo of the National Institute for Occupational Safety and Health, which conducts medical device testing, and included "a test report showing compliance with the N95 standard despite the respirators not meeting the minimum standard for N95 respirators."
Since a national emergency was declared in the U.S. on March 13, more than 3,600 Chinese-made products categorized as "surgical respirators" have been listed with the FDA, a ProPublica analysis of government data shows. In all of 2019, the total number of surgical respirators registered with the FDA was five.
"There are a lot of people producing face masks who are not necessarily reputable suppliers or historic suppliers of this product," said Phil Farinelli, vice president at Government Scientific Source, a Northern Virginia supplier that sold KN95s to the National Institutes for Health. "I probably get 10 emails a day from people trying to sell me face masks from China."
The NIH, the agency responsible for public health research, signed a separate contract worth nearly $700,000 for respirator masks in March with Missouri-based Phoenix Textile Corp., federal data shows.
The original contract was for N95 masks, the agency said in a statement to ProPublica. But because those were unavailable, Phoenix Textile proposed KN95s as an alternative.
"When NIH received the order and learned that the masks were not FDA-approved, NIH tested the products using the FDA standards for respirators and the product had failed," the agency said.
NIH requested a refund for the masks it had already received, will not pay for any more and plans to return the masks to Phoenix Textile. Executives with Phoenix Textile did not respond to an email and voicemail requesting comment.
Tests of some imported respirator masks are finding that they often do not provide the level of protection they advertise. Evan Floyd, a professor at the University of Oklahoma's Health Sciences Center, has been testing the filtration capability of KN95 masks purchased by the state of Oklahoma and private businesses.
Around one-third of the approximately 70 brands he has tested thus far do not meet the 95% filtration standard, Floyd said.
Dr. John Howard, the director of NIOSH, said in an FDA webinar on Tuesday that the agency recently had tested over 130 international respirator models and found that more than half were "substandard."
The Indian Health Service purchased 4,000 KN95 masks manufactured by a Chinese firm, ZhangJiaGang ShineYa Sanitary Products Co. Ltd., in an April 9 contract, an IHS spokesman said. The contract is separate from the Fuentes deal. The masks were sent to the IHS office in Bemidji, Minnesota, which serves tribes in Illinois, Indiana, Michigan, Minnesota and Wisconsin.
Half of the masks are still in the Bemidji area office and "will not be distributed to health care personnel," an IHS spokesman said. The other 2,000 masks are being used by IHS environmental health officers "and are being used in non-health care settings," he said.
The company's listed U.S. agent, John Flair, did not respond to a request for comment. The U.S. vendor that supplied IHS with the masks, California-based West Coast Business Products Inc., also did not respond.
The U.S. Marshals Service purchased $77,500 worth of KN95 masks in April from Knock-Out Specialties, a Texas firm that recently began selling PPE. The masks were made in China and "the products or vendors have been registered or certified by FDA," said Drew J. Wade, a Marshals Service spokesman, in an email. They are being used in "non-medical, law enforcement situations."
But "registration" with the FDA does not mean that the FDA approves the manufacturer or its products, a fact prominently mentioned on the FDA website. FDA's registration and listing database serves merely to provide a public, central listing of companies that may sell certain medical equipment.
When asked to clarify if the masks were just registered with the FDA or had some further certification, Wade responded: "I'm not sure I can sufficiently answer that question at this time. USMS holds certificates that appeared to denote some sort of FDA approval."
John Bottone, the owner of Knock-Out Specialties, did not respond to a phone call and email seeking comment.
One agency that kept up with the FDA's shifting rules was the Department of Energy's National Nuclear Security Administration. In a contractwith a Georgia-based vendor, American Dream Builders, the agency purchased over $400,000 worth of KN95 masks. An NNSA spokeswoman identified the masks' manufacturer as "Guangzhou Powecom Labor Insurance Supplies Company LTD," which does appear on the FDA-approved list.
Another manufacturer was originally supposed to fulfill the order, spokeswoman Kate Hewitt said. But when the FDA updated its criteria and the original manufacturer fell off the approved list, the purchase order for the mask contract was modified on May 18 to change to "an FDA-approved manufacturer," Hewitt said.
The Federal Emergency Management Agency also appears to have purchased KN95 masks from Guangzhou Powecom, although FEMA provided ProPublica with a slightly different manufacturer name when asked abouta $4 million contract for KN95 masks it signed in May.
FEMA's vendor was Osirius Group, an automotive manufacturing firm based in Birmingham, Michigan. Timothy Smith, Osirius Group's CEO, said in an email that "they are the same company." Osirius' first shipment to FEMA was set to arrive this week.
Guangzhou Powecom and other firms with the FDA's endorsement are being inundated with orders, Smith said.
"The FDA list has become a bible of sorts and any one on that list gets overrun," he said via email. He said his firm has been doing business in China since 1992.
Our country's long history of structural racism stands at the center of why police brutality, COVID-19 and the opioid crisis are disproportionately killing black Americans, including in Chicago.
This article was first published on Friday, June 5, 2020 in ProPublica.
We had planned to write this week’s newsletter about a story we published examining a sharp increase in opioid overdoses in Cook County at the same time the death toll from the coronavirus pandemic continues to rise here. But the killing of George Floyd in Minneapolis and subsequent civil unrest have us thinking about what those seemingly separate crises have in common.
Opioid-related deaths, police brutality and COVID-19 are all disproportionately killing black Americans, including in Chicago.
That brutal trend became clear as we began reporting on overdoses after getting a tip that the number of opioid-related fatalities was up this year. We analyzed death records from the Cook County Medical Examiner’s Office and found a stunning increase: More than twice as many people have died or are suspected to have died from opioids so far this year than this time last year.
As with so many stories we’ve both reported, it was impossible to not see the disparities. More than half of the dead were African Americans, many of them from Chicago’s West or South sides.
Kathleen Kane-Willis, a researcher with the Chicago Urban League who has written about the impact of opioids on African Americans, told us black drug users have higher overdose mortality rates for many of the same reasons that they’re more likely to die from COVID-19: higher rates of poverty, less access to effective medical treatment, more underlying health conditions.
The underlying causes driving Chicago’s opioid crisis and COVID-19 are sadly relevant to the national conversations we’re all having now about police violence and racial inequity.
Our colleague Mick Dumke likes to remind us that police brutality and disparate enforcement in black communities are symptoms of broader inequities and white supremacy. Our country’s long history of structural racism — and the segregation, disinvestment, loss of job opportunities and chronic stress that come with it — stands at the center.
This is what we’re thinking about as we consider Floyd’s death and the ensuing protests, and decide on a reporting path for ourselves as a news organization. Here are some of the recent stories we’re reading that are helping us get to the heart of these issues and offer context on how we got to this point.
This week, WBEZ and City Bureau partnered to report on modern-day redlining, as banks have invested more in a single white Chicago neighborhood than all of the city’s black neighborhoods combined.
Chicago magazine had an interesting piece on how one elected official in suburban Evanston was able to do something that had been a political non-starter for decades: pass legislation approving reparations for African Americans.
Last fall, our colleague Logan Jaffewrote about so-called sundown towns, focusing on one community in southern Illinois with a lengthy history of racism where many black people continue to feel unwelcome.
Black lives are being lost to COVID-19 at twice the rate of others. For protesters we talked to, that’s one more reason to be on the street. “If it’s not police beating us up, it’s us dying in a hospital from the pandemic,” one said.
This article was first published on Friday, June 5, 2020 in ProPublica.
WASHINGTON — On Tuesday, when he decided to protest, William Smith, 27, used a red marker to write a message on the back of a flattened cardboard box: “Kill Racism, Not Me.”
As he stood alone, somber, he thought about George Floyd, a fellow black man whom he’d watched die on video as a Minneapolis cop kneeled on his neck eight days earlier. “Seeing the life leave his body was finally the last straw that broke the camel’s back for me,” he said.
But he also thought about people he knew, a handful of them, who died after catching the new coronavirus. “They were living in impoverished areas. Couldn’t get proper treatment. Lived in crowded conditions, so social distancing was hard to do. And they were still forced to go to work and be put in harm’s way.”
When speaking out against the loss of black lives, it is tough to separate those who die at the hands of police from those who die in a pandemic that has laid bare the structural racism baked into the American health system. Floyd himself had tested positive for the coronavirus. Eighteen black protesters interviewed by ProPublica were well aware that black lives were being lost to the virus at more than twice the rate of others, and that societal barriers have compounded for generations to put them at higher risk.
It was fueling their desire to protest and their anxiety about joining the crowd. But they flocked to the White House on Tuesday afternoon, one day after peaceful protesters there were tear-gassed so that President Donald Trump could hold up a bible for a photo op at St. John’s Episcopal Church. There were tanks on the streets, along with a battalion of federal agents, military troops and police. Many of the protesters said they were willing to sacrifice their bodies, either to violence or the virus, to be heard.
In front of the White House stood Caleb Jordan, who turns 21 on Saturday. He showed up with an overstuffed backpack to make sure his 62-year-old grandmother, Carolyn Jackson, had enough water to drink and a hoodie to protect her arms in case of violence. “I don’t know what I would do if anything happened to her,” he said. Some people had on masks. Some did not. Some pulled their masks down to talk or breathe. “I’m not comfortable with that,” he said. She’s got a chronic lung condition, and he had been so worried about her catching the coronavirus in the past few months that he wouldn’t hug her. But then she mentioned that she drove by the protests on Sunday, and immediately he asked, “Why didn’t you take me?”
He had been losing sleep over what he was seeing in social media and on TV, having nightmares in which he was fighting a “real-Jim-Crow-looking white guy in a white button-down shirt, black tie, sleeves rolled up.” His mom told him he was fighting racism. “It’s like obstacle after obstacle,” he said. “If it’s not police beating us up, it’s us dying in a hospital from the pandemic. I’m tired of being tired. I’m so tired, I can’t sleep.” It was something he continued thinking about until he couldn’t help himself, sending a text at 3 a.m. asking his grandmother if they could attend together. “I thought about it and said, ‘This is a teachable moment,’ ” she recalled.
So Jackson took the day off from her job as an accountant at a hospice organization and put on some peace sign earrings and a T-shirt from the 20th anniversary of the Million Man March. On the car ride into the city, her grandson asked about her struggles with race. She explained what it’s like being a professional black woman with over 30 years experience who still feels overlooked for opportunities because of questions about her qualifications. Her awareness of being treated differently dates back to how her white paternal grandmother favored her lighter-skinned cousins. She found solace in her black maternal grandmother, who would comb her hair while she sat between her legs. Jackson wants her grandson to feel that kind of comfort from her.
That desire extends to her mission to help the black community understand palliative care is an option that can offer dignity and support at the end of life. “Because when people hear hospice, their hands go up and they say, ‘I don’t want to hear it.’” She’s also heard that resistance when it comes to getting tested for the coronavirus; she has gotten tested twice and plans to get tested again. She feared being exposed on Tuesday, but being here with her grandson was too important to miss. “We internalized a lot with my generation,” she said, “but I think it’s important for him to see this.”
N.W.A.’s “Fuck Tha Police” blared from a nearby speaker outside St. John’s Episcopal Church until an interfaith group of men and women bowed their heads and began to pray. Among them was Timothy Freeman, pastor at Trinity African Methodist Episcopal Zion Church, who wore a brightly colored kente cloth-inspired mask, its vibrant yellows and reds standing in stark contrast to his ministerial black suit and white clerical collar.
Freeman, 42, knows eight people who have been diagnosed with the virus; one died. For two weeks, a sick friend had a fever and could barely move from fatigue but refused to get tested, running through all the scenarios of what might happen if he had it: What if he wound up isolated in an ICU with no one to advocate at his bedside? Another sick friend worried an ambulance would take him to a hospital that he didn’t trust. These conversations, the pastor said, are always infused with an awareness of the medical system’s record of neglect and abuse of black people, from dismissing their pain to using their bodies for research without consent. The virus has forced this all top of mind.
A licensed occupational therapist for 19 years who spent a decade managing a skilled rehab facility, Freeman said he has seen racial disparities in health care firsthand and that access to adequate insurance coverage is crucial. “I have seen diagnostic tests not performed … and hospitalizations cut extremely short — or not happen at all — because of insurance.” COVID-19 is affecting black and brown people in disproportionate numbers, “and not just because we’re black and brown, but because of the social and economic conditions people are forced to live in,” he said.
“All of it comes together. What happened with George Floyd publicized to the world the experience that we live,” he said. “It’s a conglomeration of everything.”
A block away from the prayer group, Elizabeth Tsehai, 53, drove slowly in her BMW SUV, honking her horn, as federal agents in riot gear began to march past the crowd just behind her. She had a Black Lives Matter T-shirt displayed on the dashboard and a bike rack on the top of her car that she joked made her look like the “caricature of a soccer mom.”
She stopped her car on the road and remained there as protesters to her left took a knee. There was some heckling from the crowd but no one was in anybody’s face. A Secret Service agent warned her to move. Her response: “Arrest me. I can’t breathe!” Agents then pulled her from her car and to the ground and handcuffed her. “I didn’t resist because I know they just arrest you for resisting arrest,” she said. “But the minute they pulled me up on my feet, I was talking all kinds of trash.”
Her car was left unlocked in the middle of the street, where it was protected by protesters. She was questioned and released. She said agents told her they were afraid she was going to hit protesters because people have been using their cars as weapons. They told her to move it and leave. The Secret Service did not respond to questions about this incident.
“Ordinarily, I would not get involved,” Tsehai said. But George Floyd’s death was enraging, as were “all of the things that came before it.”
All of the things.
How a white nurse looked her up and down when she arrived at the hospital to give birth to her son and sneered, “Can we help you?”
How her brothers, who live in Minneapolis, recount being pulled over by police for driving while black.
How a black man couldn’t watch birds in Central Park last week without having the police called on him.
“The pandemic is hitting black people hard and exposing these structural inequalities,” she said. “Then on top of that, you get Amy Cooper … weaponizing her white privilege at a time when he might end up in jail, where infection is rife.
“But when they manhandled protesters who were peaceful, that was a bridge too far,” said Tsehai, who grew up in Ethiopia under an authoritarian regime during a period known as Red Terror. She didn’t know life without a curfew until she moved to the United States to attend Georgetown University 35 years ago.
“Moments like this are quite unusual,” she said. They can also inspire change, a message she shared with her children, ages 12 and 14, when recounting her ordeal with them. “I want these children to live in a different world. It’s not enough to read about it and get outraged and talk about it at the dinner table. Silence makes you complicit.”
