Clinicians' struggles in coronavirus hotspots may well preview what medical providers in other states could face amid a national shortage of personal protective equipment.
This article was first published on Saturday, March 28, 2020 in ProPublica.
When nurses at one Washington State hospital complained about having to use expired respirators, they allege that staff were ordered to remove stickers showing the equipment was years out of date.
Nurses at one hospital in southeastern Washington state have alleged that, amid the COVID-19 pandemic, they were ordered by supervisors to use one protective mask per shift, potentially exposing themselves to the novel coronavirus.
At another hospital, just east of Seattle, nurses had to use face shields indefinitely.
At a third hospital, on Washington's border with Oregon, nurses reported that respirators were expired. The hospital responded, the nurses said, by ordering staff to remove stickers showing that the respirators might be as much as three years out of date.
The accounts these nurses provided are drawn from nine complaints filed by the Washington State Nurses Association with the state Department of Labor & Industries since March 11. They paint a picture of how the first state hit by COVID-19 continues to struggle to provide adequate safety measures for medical workers.
Their struggle may well preview what medical providers in other states could face amid a national shortage of personal protective equipment, or PPE. The complaints from Washington also show the increasing sense of fear, frustration and powerlessness many nurses and other medical workers feel as COVID-19 pummels the healthcare system.
As of this weekend, the Washington Department of Health has reported 3,700 known COVID-19 cases in the state and 175 deaths.
ProPublica contacted all nine hospitals that were the subject of a nursing association complaint. Four responded. They said they were taking measures to protect their employees, but emphasized the unprecedented crisis in which their hospital staffs are now working. In a press briefing Thursday, Washington Gov. Jay Inslee said the federal government had supplied the state with "significant shipments of personal protective equipment" but added that he had "profound long-term concerns about being able to procure these necessities." Inslee, a vocal critic of the Trump administration, reportedly clashed with the president in a conference call with governors Thursday, according to The Washington Post, pleading with him to take more action.Bottom of Form
Some nurses in Washington state told ProPublica that they feel caught between their responsibility to care for patients and their own safety. They believe they have no choice but to keep working, at great personal risk and with limited means to raise concerns within their chains of command. They could be disciplined for talking to the media, and some said they had been explicitly warned about that in emails sent by hospital administrators. To refuse an assignment on safety grounds, they said, could find them ostracized by colleagues or, worse, fired for insubordination.
"It's a healthcare war zone," said a critical care nurse who works at one of the nine hospitals named in the complaints and, like all nurses interviewed for this story, asked to remain anonymous.
She told ProPublica that she has had to reuse masks and other PPE, if she can obtain it at all. She uses a simple surgical mask — a paper cover with ear loops, no eye cover — even when working with patients waiting for COVID-19 tests, because that's all that's available. Community members have been asked to donate handmade masks. She wears one over her surgical mask; it doesn't protect from viruses but at least is one more layer. Every night when she comes home, she strips down in the garage and throws her dirty hospital scrubs in the washer before rushing in to take a shower.
Workers at a VA hospital in New Mexico have been told not to wear face masks in certain cases, even though earlier CDC guidance said masks can protect against spread of the coronavirus.
"Never in a million years did we think when we were in nursing school that our employer would not provide us with the PPE they are legally obligated to provide us with, to care for those patients," she said.
Her supervisors acknowledge the shortage, she said, but have told staff members that unless they make do, they could run out of all protective gear, making their situation even more precarious.
"We take an oath of 'do no harm,'" the nurse said. "Would we be willing to take care of these patients with nothing?" She has a family, some of whom would be especially susceptible to the disease.
"I don't know what I would do," she said. "We are continuing to reuse this equipment so hopefully we don't have to make that choice."
'This is what you signed up for'
Nurses in Washington, where the virus first surfaced in the U.S., believe their early experience can help prepare healthcare workers elsewhere. The Washington State Nurses Association has even produced a list of recommendations for other states, called "Lessons learned from the front lines." Those lessons include, "Know your employer's plan for PPE (personal protective equipment)," and "Know the testing and treatment protocols now."
When the novel coronavirus spread across Washington in February and March, the lack of supplies in hospitals, coupled with uncertainty over what protective measures were needed, presented many nurses with a difficult choice. Nurses given a dangerous job could accept the assignment and its attendant risks, or refuse and face possible discipline. The WSNA, a union that represents more than 17,000 nurses, advised members who refused an assignment to stay and do other jobs. For those nurses who accepted an "abnormally dangerous" assignment, the union advised filling out what is called an ADO form. ADO stands for Assignment Despite Objection.
When ProPublica mentioned ADO forms to some nurses in Washington, they did not react with enthusiasm. "It's the stuff of fairytales," said one nurse in the Seattle area who specializes in mental health. "Nurses, administratively, are strongly discouraged to use the forms or outright shamed for documenting what they are uncomfortable with in a caregiving situation."
Wearing swim goggles for face protection and trash bags for surgical gowns, frontline healthcare workers have been forced to fend for themselves amid federal stockpile shortages.
Under collective bargaining agreements, nurses disciplined for refusing an assignment can push back, arguing that the discipline lacked "just cause." But the WSNA has warned its members that given the current national and state emergency declarations, the resolution of any such objection "would likely be delayed and the outcome may be uncertain."
Ruth Schubert, the association's communications director, said the WSNA has received about 70 Assignment Despite Objection forms related to the coronavirus. She declined to provide copies, citing confidentiality, but did share excerpts, including one that said: "Continue to be asked to reuse single use masks for COVID-19 modified droplet patients and wear ill-fitting gowns that fall off shoulders. Goggles not available." Some nurses are unlikely to fill out an ADO for fear "that management will see them as complainers," Schubert wrote in an email.
The WSNA said nurses fear being disciplined for talking with the media. A doctor from PeaceHealth St. Joseph Medical Center in Bellingham, close to the Canadian border, told The Seattle Times on Friday that he was fired after he raised multiple concerns about the hospital's lack of protective measures against COVID-19. A spokesperson for PeaceHealth St. Joseph confirmed the doctor was fired but had no comment because the physician was employed by another company, called TeamHealth.
PeaceHealth St. Joseph is one of the nine hospitals the state nursing association has filed a complaint against, for allegedly asking nurses to reuse and share their protective equipment without proper cleaning. As of Saturday morning, PeaceHealth had not responded to ProPublica's inquiries about this incident or the complaints. TeamHealth, the doctor's primary employer, told ProPublica that the physician has "not been terminated," and that TeamHealth is "committed to engaging with him to try to find a path forward. Now more than ever, we need every available doctor, and we will work with [him] to find the right location for him."
A Seattle nurse who specializes in oncology said her hospital's administration initially downplayed the risks: "I had a manager come in and tell me, 'This is just like the common cold.'" The nurse added, "We're being told, business as usual, this is what you signed up for."
Some nurses in Washington have turned to Facebook to express their frustrations. (ProPublica isn't identifying the nurses in these threads, but did confirm their nursing credentials through state licensing records.)
Commenting on a Facebook post that warned against using cloth masks, one registered nurse wrote, "We need to be able to wear something!!!"
A different post linked to a Bloomberg story about hospital workers making masks from supplies bought at craft stores and Home Depot, including industrial tape and foam. "No offense but I'm not wearing someone's arts and crafts project with this thing," wrote one registered nurse.
Facebook posts linking to a Tacoma News Tribune story about nurses reusing disposable masks generated multiple me-too threads. "We are doing this," wrote a nurse in Everett. "Our hospital ... also," wrote a nursing assistant southeast of Seattle. "It's everywhere," one RN wrote, followed by a second RN, "This is everywhere," followed by a third RN, "Yep."
One nurse told ProPublica that she wrote on Facebook that she had decided to take a break from her job because she could no longer deal with what she considered an unsafe environment.
She was met with criticism by another nurse, who commented that they didn't get into this field to "cut and run." That devastated the nurse who spoke to ProPublica, who responded she didn't "sign up to die."
The nurse, who works in an eastern Washington hospital, started to get concerned when, on March 10, her hospital loosened some of its PPE guidelines. She is now using up all her vacation and sick leave because she's nervous to return to work. If she isn't approved for an extended leave of absence, she said, she is "100 percent prepared to resign."
'These are not normal times'
The most recent complaint filed by the state nurses association was on March 23 against Overlake Medical Center. Based in Bellevue, just east of Seattle, Overlake has had dozens of patients with COVID-19 on any given day. On Friday, the number was 40, said Morgan Brice, a hospital spokeswoman. At least 11 patients have died at Overlake from COVID-19, according to Brice. A number of them arrived at the hospital under "comfort care," meaning their death was imminent and the hospital made efforts to keep them comfortable in their final days.
The complaint filed with the Department of Labor & Industries said nurses were being required to reuse face shields "indefinitely." "They must clean them themselves and ... store in their own locker for reuse day after day, until the chinstrap is loose," the complaint says, adding: "RNs report the chinstrap is loose after one 12-hr shift." The complaint also said the hospital was failing to make sure that notification of exposure was reaching nurses on their days off, "thus prompting additional community and family exposure."
Brice, in an email, told ProPublica that Overlake had yet to receive a copy of the complaint and would not respond to the specific allegations until it has. But the hospital, she wrote, is "committed to investigating the facts related to any complaint and acting appropriately." She outlined some steps Overlake has taken during the outbreak, including having a team of nurses "committed to the health of our employees."
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"We have dedicated extensive resources to training staff on how to use and maintain their PPE," Brice wrote. "We have posted videos, daily FAQs for staff, formed a PPE float team to help guide employees, along with our managers rounding the floors on a consistent basis. We know we have taken extraordinary and proper measures to protect the health and safety of our staff, while we respond to the medical challenges being presented on a daily basis."
The complaints filed with Labor & Industries use a fill-in-the-blank form, with a narrative section to describe alleged hazards.
On March 11, the nurses association filed a complaint against St. Joseph Medical Center in Tacoma, saying nurses were being directed to reuse and share protective equipment. The complaint also alleged that nurses weren't being fit-tested for N95 masks, a protective respiratory device worn over the face. Masks that aren't properly fitted to a person's face can admit contaminated air.
CHI Franciscan, the medical system that includes Tacoma's St. Joseph, said it is cooperating with the investigation but was told by the Department of Labor & Industries that no action is required at this time. The system denied that nurses "have been or will be asked to use PPE in a manner not in compliance with CDC, FDA and DOH guidelines," according to an emailed statement from Cary Evans, the company's vice president for communications and government affairs.
The hospital is operating with "7-12 days of PPE" and said it has not had a situation where demand for PPE exceeded supply. Administrators have expanded fit testing for N95 masks. They are also accepting donations of PPE gear from the community. Normally, a 30-day PPE supply is preferred, according to the Washington State Hospital Association.
"These are not normal times," Evans' statement said, "and we are doing everything we can to keep our staff and patients safe, while also conserving masks under the latest local CDC guidelines."
The same day it filed the St. Joseph complaint, the nurses association submitted seven others, two against hospitals within the same medical system: Multicare Tacoma General Hospital and Multicare Good Samaritan Hospital in Puyallup, a community southeast of Tacoma. A spokesperson for the system wrote that all employees "have the appropriate personal protective equipment (PPE) they need today to do their jobs safely" and noted that hospital staff are allowed "to preserve PPE resources needed to care for our most critical patients."
"Due to supply chain disruptions, health systems worldwide are dealing with shortages of PPE," the statement read.
Another complaint, filed against PeaceHealth Southwest Medical Center, a hospital in Vancouver, across the Columbia River from Portland, Oregon, said nurses were reporting lack of access to masks and respirators. When the nurses reported that respirators were outdated, the hospital "directed staff to remove outdated 2017 and 2019 'service by' stickers on equipment," the complaint said.
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The hospital did not respond to requests for comment from ProPublica as of Saturday morning.
Beth Zborowski, senior vice president of membership engagement and communications for the Washington State Hospital Association, said a lack of PPE is probably the medical community's top problem in the state, in terms of its efforts to fight COVID-19. The association advises hospitals to follow Department of Health and CDC recommendations, though many nurses say the latter keeps changing.
"Prior to the pandemic, masks were available on carts outside of rooms," Zborowski said. "What started happening is those things started disappearing pretty quick. People had to put conservation measures in." It's one reason the state canceled elective procedures in recent weeks.
It's unclear how many healthcare workers in the state may have become ill as a result of COVID-19, though a doctor at EvergreenHealth near Seattle has been infected and Schubert, of the state nursing association, said she knows of nurses who have become sick. Zborowski said the state hospital association does not have a formal record but added she has not heard about many front-line medical workers becoming ill, as they have in New York and Italy. She hopes that means the conservation and safety measures hospitals are taking are working. The goal is to preserve the PPE; otherwise, "I think we will start to see healthcare workers getting sick."
Eileen Ravella, a physician assistant at an urgent care facility in Olympia, said her employer is doing well under the circumstances, trying to keep COVID-19 cases cordoned off from other patients and using a drive-through testing area they set up to meet the need. This is helping them preserve PPE, but she knows the system is breaking under the weight of the pandemic.
"I think we all have to step up and do our best despite the obstacles," Ravella said. "Those patients need us."
A nurse who works in a western Washington emergency room said that a few weeks into the pandemic, the crisis conditions had begun to feel normal, "which is kind of horrible, too."
Now she's advising nurses in other states about what she's experienced. Initially, many of them refused to take her seriously.
She admits that she downplayed COVID-19 at first. Then, in mid-March, she found out about the EvergreenHealth doctor who had contracted the virus.
"It became really real then that some of us may not make it out of here alive," she said.
A few days later, she and her colleagues received a message from their hospital administrator, advising them to complete their advanced directives — basically a living will.
"[N]ow with COVID-19 making who gets sick an unpredictable event," the message read, "it's an important time to get this done."
Leaders at the Department of Veterans Affairs say they are ready to answer the call to assist HHS or FEMA. But the call has not come.
This article was first published on Friday, March 27, 2020 in ProPublica.
The Trump administration is leaving untapped reinforcements and supplies from the U.S. Department of Veterans Affairs, even as many hospitals are struggling with a crush of coronavirus patients.
The VA serves 9 million veterans through 170 hospitals and more than 1,000 clinics, but it’s also legally designated as the country’s backup health system in an emergency. As part of the National Disaster Medical System, the VA has deployed doctors and equipment to disasters and emergencies in recent instances such as Hurricane Maria and the Pulse nightclub shooting in Orlando, Florida. The VA system has 13,000 acute care beds, including 1,800 intensive care unit beds.
But for the coronavirus pandemic, VA Secretary Robert Wilkie told lawmakers this week that the agency won’t spring into action on its own. Instead of responding to pleas for help from states and cities, Wilkie said he’s waiting for direction from the Department of Health and Human Services or the Federal Emergency Management Agency.
And those calls, for the most part, haven’t come. HHS hasn’t asked the VA for significant help with the coronavirus pandemic. FEMA did not take a leading role in the government’s response until last Friday, and it has yet to involve the VA either.
“VA stands ready to support civilian health care systems in the event those systems encounter capacity issues,” press secretary Christina Mandreucci said. “At this time, VA has not received specific requests from FEMA for assistance.”
The White House referred questions to the VA. The VA referred a question about taking directions from HHS and FEMA to those agencies. HHS referred questions to FEMA, and FEMA referred questions to the VA.
The VA has fielded a handful of limited tasks. It asked 12 health technicians and nursing assistants to volunteer to help HHS and the Centers for Disease Control and Prevention with coronavirus screenings for two weeks in February. The agency sent 14 medical technicians to help HHS with screenings at an Air Force base in California where evacuees from the Diamond Princess cruise ship were being quarantined. And a spokeswoman for CalVet, the state’s veterans agency, told ProPublica that the VA emergency manager in the region has helped provide supplies such as N95 masks.
Lawmakers are frustrated to see the VA largely sitting on its hands as the crisis escalates.
“It is unconscionable that HHS has not utilized every tool it has to address the real suffering of individuals in this nation and called upon VA,” Sen. Jon Tester of Montana, the ranking Democrat on the Senate Veterans’ Affairs committee, said in a March 25 letterto HHS Secretary Alex Azar. “States, communities and patients are already suffering as a result of HHS’s inaction. Get them help now.”
According to the VA’s pandemic plan released on Friday, the agency’s role in the governmentwide response may include helping emergency responders with protective gear, screening and training; helping to staff FEMA’s operations teams; dispatching advisers to state and local public health authorities; supplying medicines and equipment; and helping with burials.
The stimulus deal that the Senate passed late Wednesday includes $27 billion for HHS to reimburse the VA for providing care to the general public. That’s on top of $20 billion to help the VA care for veterans.
Just a month ago, at a House budget hearing, Wilkie declined additional funding. “Right now I don’t see a need for us,” he said. “We are set.”
The VA held its first planning meeting on the coronavirus on Jan. 22, the day after the first case was confirmed in the U.S., according to the agency’s response to an inspector general report released Thursday. But the department did not implement measures until two days after the World Health Organization formally declared a pandemic, on March 11. The VA did not issue guidance on screening patients until March 16.
Wilkie abruptly fired his deputy last month and is under investigation by the VA’s inspector general for allegedly seeking damaging information about a congressional staffer who said she was sexually assaulted at a VA hospital. (He denies doing so.) Wilkie took time off in recent weeks and has taken a back seat at White House task force meetings. Since joining the White House’s Coronavirus Task Force on March 2, Wilkie has spoken publicly only once, on March 18. (Mandreucci said Wilkie has attended 20 task force meetings.) At that time, Wilkie said the VA was preparing to join the disaster response but had not yet engaged.
“We are the buttress force in case that FEMA or HHS calls upon us to deploy medical professionals across the country to meet crises,” Wilkie said. “We plan for that every day. We are gaming out emergency preparedness scenarios. And we stand ready, when the president needs us, to expand our mission.”
Wilkie told Politico the VA was preparing to deploy 3,000 doctors, nurses and other emergency workers but had no timeline.
The VA’s role as the country’s emergency medical backup was first established by Congress in 1982 and is known as the agency’s “Fourth Mission.” (The first three missions are sometimes identified as care, training and research, and other times as health, benefits and memorials.) This month, a description of this Fourth Mission was suddenly scrubbed from the website of the VA’s Office of Emergency Management. Mandreucci noted it appeared on a different page.
The VA’s ability to support FEMA could be limited by demands from its own patients, who are largely older and part of the demographic that’s most vulnerable to the coronavirus. As of Friday, the VA had 571 patients who tested positive and nine who have died.
The VA’s inspector general said in a report on Thursday that health center leaders reported concerns about running out of medicines and protective gear. Leaders at the VA hospitals in Durham, North Carolina, and Detroit said they needed more ventilators. The inspector general’s report said 43% of the facility leaders surveyed planned to share ICU beds or protective gear with local providers.
“That assistance is dependent upon the availability of resources and funding, and consistency with VA’s mission to provide priority services to veterans,” Wilkie said in a March 23 letter to lawmakers.
Demand for chloroquine and hydroxychloroquine surged over the past several days as President Donald Trump promoted them as possible treatments for the coronavirus.
This article was first published on Tuesday, March 24, 2020 in ProPublica.
Pharmacists told ProPublica that they are seeing unusual and fraudulent prescribing activity as doctors stockpile unproven coronavirus drugs endorsed by President Donald Trump.
A nationwide shortage of two drugs touted as possible treatments for the coronavirus is being driven in part by doctors inappropriately prescribing the medicines for family, friends and themselves, according to pharmacists and state regulators.
"It's disgraceful, is what it is," said Garth Reynolds, executive director of the Illinois Pharmacists Association, which started getting calls and emails Saturday from members saying they were receiving questionable prescriptions. "And completely selfish."
Demand for chloroquine and hydroxychloroquine surged over the past several days as President Donald Trump promoted them as possible treatments for the coronavirus and online forums buzzed with excitement over a small study suggesting the combination of hydroxychloroquine and a commonly used antibiotic could be effective in treating COVID-19.
Reynolds said the Illinois Pharmacists Association has started reaching out to pharmacists and medical groups throughout the state to urge doctors, nurses and physician assistants not to write prescriptions for themselves and those close to them.
"We even had a couple of examples of prescribers trying to say that the individual they were calling in for had rheumatoid arthritis," he said, explaining that pharmacists suspected that wasn't true. "I mean, that's fraud."
In one case, Reynolds said, the prescriber initially tried to get the pills without an explanation and only offered up that the individual had rheumatoid arthritis after the pharmacist questioned the prescription.
In a bulletin to pharmacists on Sunday, the state association wrote that it was "disturbed by the current actions of prescribers" and instructed members on how to file a complaint against physicians and nurses who were doing it.
"People are losing their minds about this product," said Brian Brito, president of SMP Pharmacy Solutions in Miami. "We're selling so much of this stuff and people are just stockpiling it prophylactically if anybody in their family gets sick — they're just holding on to it.
The two drugs are only available through a prescription and cannot be purchased over the counter. Hydroxychloroquine, sold under the brand name Plaquenil, is approved to treat lupus and rheumatoid arthritis while chloroquine is an anti-malarial treatment.
There is little evidence that the drugs work to treat coronavirus, although clinical trials are underway to find out. But as coronavirus cases multiply and protective gear for medical workers vanishes from emergency rooms, many patients and physicians see the drugs as the only hope to reverse the course of serious disease.
Brito said his pharmacy had about 800 tablets on Monday and were nearly sold out in about an hour. One doctor called and asked for 200 tablets, but the company refused. "He was a little upset about it but he understood and he went quickly from 200 to 42 tablets, which is essentially treating two people," Brito said. "So yeah, they're stockpiling it."
A pharmacist in Houston, who asked to remain anonymous for fear of retaliation and violating patient privacy, said he was recently asked by a surgeon for an unusually large quantity with unlimited refills. "He said it was because his wife had lupus," the pharmacist said, "but when I asked him for her name and diagnosis, he told me just to put it in his."
Lupus patients are reporting difficulty in refilling their prescriptions for the drug. On Monday, the Lupus Foundation of America issued a joint statement asking the White House Coronavirus Task Force to "take action to ensure current supplies are allocated for patients taking them for indicated uses." Several states in the past few days have already moved to limit prescriptions of the drugs, neither of which is approved to treat the coronavirus. Trump, in press conferences and tweets over the past week, has promoted the use of the drugs as potentially blunting the impact of the COVID-19 outbreak.
Trump's unproven claim that hydroxychloroquine could be used to treat COVID-19 has led to hoarding, putting Lupus patients and others at even greater risk. As of Saturday afternoon, Anna Valdez had 27 pills left. That number is now down to 25.
"It's unfortunate that a news conference, I think prematurely, made it sound like this was the answer, and that's led to this panic," Michelle Petri, director of Johns Hopkins University School of Medicine's Lupus Center, said Friday. "I have spent the last two days trying to help lupus patients who actually need their refills." She said some patients have refills on back order while others are being provided smaller amounts than usual.
The West Virginia Board of Pharmacy, in an alert Saturday, ordered pharmacists to limit new prescriptions to no more than 30 tablets and only to cases where the drugs were being used for approved indications.
"Currently, both nationally and in West Virginia, some prescribers have begun writing prescriptions for these drugs for family, friends, and coworkers in anticipation of Covid-19 related illness," the board wrote.
Texas and Ohio have also restricted prescribing of the drugs. Louisiana on Sunday also issued an emergency rule limiting when the drugs can be prescribed, citing "inappropriate use" and "hoarding." On Monday, the Louisiana Board of Pharmacy said it was rescinding that order because manufacturers had boosted distribution of the drugs.
Experts are warning that any use of the drugs outside of a hospital setting can be dangerous, and admonished doctors to stop prescribing the medicines inappropriately.
Daniel Brooks, the medical director of the Banner Poison and Drug Information Center in Phoenix, said it was "immoral" for physicians to hoard the medications.
"One should not be selfish and scared, especially medical providers," he said. "I find it incredibly embarrassing and unfortunate that physicians appear to be prescribing these medications inappropriately."
This weekend Brooks cared for a man in his 60s who died after ingesting a version of chloroquine commonly used to clean fish tanks. The man, who thought he might have COVID-19, took a small amount of the substance in a misguided effort to treat his symptoms. His wife was also hospitalized after taking the substance but survived.
Brooks said the amount the couple ingested was equivalent to a couple days' worth of prescription chloroquine.
Ken Thai, the owner of a chain of Los Angeles-area pharmacies, said his stores are witnessing a rash of inappropriate prescribing.
"A lot of physicians, unfortunately, are writing high amounts for more than the required number of tablets and calling in five, six, seven and eight prescriptions at a time," he said. "I don't want to insinuate what is going on, but it is very unusual."
He said his pharmacists are declining to fill suspicious orders and telling prescribers they don't have enough of the medication on hand to complete those requests. Among the prescriptions flagged are those for people who have not previously taken the drug as well as orders from doctors who do not typically treat lupus and rheumatoid arthritis patients.
"If a doctor is writing a prescription for himself or aunts and uncles, that is usually a red flag for us," he said. "Whatever we have in stock, we have to preserve for the patients we currently service."
On Twitter, pharmacy workers traded stories about dentistsand opthamologistsrequesting hydroxychloroquine under dubious pretenses. "A dentist just tried to call in scripts for hydroxychloroquine + azithromycin for himself, his wife, & another couple (friends)," tweeted a pharmacist in Eugene, Oregon. "I have patients with lupus that have been on HCQ [Hydroxychloroquine] for YEARS and now can't get it because it's on backorder."
Steve Moore, president of the Pharmacists Society of the State of New York, said medical providers hoarding the drugs is occuring in the state, which has the highest number of coronavirus cases in the country.
"That's a double whammy," he said. "We're potentially taking that medication away from patients with autoimmune conditions and patients with the actual virus that may need treatment."
Administering coronavirus tests requires time and supplies that are already running out. But aggressive testing has proven to be the best way to track and isolate the disease, stopping its spread. The best path forward depends on where you are.
This article was first published on Monday, March 23, 2020 in ProPublica.
There's a seeming paradox in experts' advice on testing people for COVID-19. A growing number of epidemiologists are calling for a nationwide regimen of tests to identify hot spots and allow public health workers to isolate the close contacts of anyone who's infected.
Yet New York City, the epicenter of the outbreak in the U.S., has ordered doctors not to test anyone who is "mild to moderately ill" with COVID-like symptoms, a position also taken by Los Angeles. As New York's Health Department succinctly put it: "Outpatient testing must not be encouraged, promoted or advertised."
Dr. Tom Frieden, former health commissioner of New York City and former head of the Centers for Disease Control and Prevention, said both viewpoints make sense.
"Where you stand depends on where you sit," Frieden said. "Local context is all important. In New York City, today, you should not get tested if you have mild symptoms."
The reason, he said, is that the health care systems in places like New York, Los Angeles and Seattle are about to be overwhelmed by a wave of people seriously ill from COVID-19. They know it's coming. Administering each test takes up protective gear, swabs and health care workers' time, all of which should be reserved for patients with life-threatening conditions. On Monday, for instance, NewYork-Presbyterian Hospital reported that it had more than 600 patients with COVID-19.
Conversely, Frieden and other experts pointed out, the United States will need to pursue a policy of very broad testing if it hopes to slow the spread of the disease and restart parts of the economy anytime soon. Frieden noted that one of the countries most effective in lowering its infection rate, Singapore, had great success in tracing and isolating the contacts of each infected person. That is no longer possible in New York state, which has reported more than 20,000 positive tests and has many times that number of people infected. But he said it remains doable in many other cities and towns.
"In places where you've got the cases way down, or there are no cases," he said, "aggressive testing will be needed."
The lack of testing continues to be a source of deep frustration across the country, with worried patients unable to find out whether they have the ordinary flu, the coronavirus or something else entirely. The availability of testing in regions that aren't hot spots still faces an array of bottlenecks, from shortages of cotton swabs to the capacity of the labs processing the tests.
Dr. Scott Gottlieb, the former head of the Food and Drug Administration under President Donald Trump, argued in a widely read Twitter commentary for a multipronged approach to fighting the virus, which will involve overcoming all of these hurdles and significantly stepping up testing nationwide. The current "shelter in place" orders, which have tens of millions of people in New York, California and other states limited to their homes and not going to work, he said, will ultimately have to be supplanted by a more targeted approach.
To do this, he wrote, the United States "must widely test our population" and "diagnose mild and even asymptomatic cases" with reliable tests that can be administered in doctors' offices. "We must have tools to identify and isolate small outbreaks so we can lean less heavily" on locking down whole swaths of society, Gottlieb wrote.
Trevor Bedford, a University of Washington virologist who has been directly involved in detecting and fighting his state's outbreak, offered a similar prescription in a recent series of tweets. Bedford's observations were prompted, in part, by a recent study by epidemiologists at Imperial College London that said countries had little alternative to maintaining strict restrictions on social contact until a vaccine is available, a process that could take 18 months. The study forecast as many as 1.1 million to 1.2 million deaths in the United States if officials backed off the sorts of measures taken by New York and California in recent days.
Bedford saidhe was not that "pessimistic," and he called for a strategy that "revolves around a massive rollout of testing capacity." Recent studies, he wrote, support the argument that a "significant" portion of the transmission of the virus arises from people whospread it before they feel sick. There also are people who infect others while never experiencing any symptoms of their own.
Something approaching universal testing would make it possible to significantly reduce such "transmission routes."
"If someone can be tested early in their illness before they show symptoms," Bedford wrote, "they could effectively self isolate and reduce onward transmission compared to isolation when symptoms develop."
He envisaged a future in which swabs are delivered to people's homes for quick return and in which drive-through testing is widely available to anyone with a car. "There are logistics involved in getting a result quickly," he wrote, "but it's really just logistics, which can be solved."
Bedford suggested an approach that appears to have worked in South Korea, which combined test results with "cell phone location data" on known positive cases, allowing notification of people who have been in proximity to confirmed cases to "self isolate and get tested."
A third pillar of Bedford's approach is a medical exam that does not yet exist — a blood test that can detect the presence of antibodies to COVID-19. Antibodies are created when the immune system successfully fights off an infection and people with them are "highly likely to possess immunity" and can "fully return to the workforce and keep society functioning."
That assumption, like many about the virus, remains the subject of research. For his part, Frieden said he was cautious about taking any action based on a test that detects antibodies. Does it mean the person is immune from a second infection? "We can't count on that," he said. "We don't yet know that."
The clash between the short-term and long-term views of testing were on vivid display in the press conference last week that made headlines for Trump's angry outburst at an NBC reporter.
Earlier in the briefing, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, sought to distinguish between the ultimate need for more tests with the immediate requirement that Americans stop gathering in workplaces, bars, streets and restaurants.
The extreme steps taken by California and New York, Fauci said, are "how you put an end to this outbreak."
"Testing is important," he said. "But let's not conflate testing with the action that we have to take. Whether or not you test, do this. I'm not putting down testing as an important issue, but people seem to link them so much that if you don't have universal testing, you can't respond to the outbreak. You really can."
Trump disparaged the notion of widespread testing as imagined by Bedford and others. "We don't want every American to go out and get a test. Three hundred and fifty million people," Trump said. "We don't want that. We want people that have a problem, that have a problem with they're sneezing, they're sniffling, they don't feel good, they have a temperature."
"It first struck me how different it was when I saw my first coronavirus patient go bad. I was like, Holy shit, this is not the flu. Watching this relatively young guy, gasping for air, pink frothy secretions coming out of his tube."
This article was first published on Saturday, March 21, 2020 in ProPublica.
As of Friday, Louisiana was reporting 479 confirmed cases of COVID-19, one of the highest numbers in the country. Ten people had died. The majority of cases are in New Orleans, which now has one confirmed case for every 1,000 residents. New Orleans had held Mardi Gras celebrations just two weeks before its first patient, with more than a million revelers on its streets.
I spoke to a respiratory therapist there, whose job is to ensure that patients are breathing well. He works in a medium-sized city hospital’s intensive care unit. (We are withholding his name and employer, as he fears retaliation.) Before the virus came to New Orleans, his days were pretty relaxed, nebulizing patients with asthma, adjusting oxygen tubes that run through the nose or, in the most severe cases, setting up and managing ventilators. His patients were usually older, with chronic health conditions and bad lungs.
Since last week, he’s been running ventilators for the sickest COVID-19 patients. Many are relatively young, in their 40s and 50s, and have minimal, if any, preexisting conditions in their charts. He is overwhelmed, stunned by the manifestation of the infection, both its speed and intensity. The ICU where he works has essentially become a coronavirus unit. He estimates that his hospital has admitted dozens of confirmed or presumptive coronavirus patients. About a third have ended up on ventilators.
His hospital had not prepared for this volume before the virus first appeared. One physician had tried to raise alarms, asking about negative pressure rooms and ventilators. Most staff concluded that he was overreacting. “They thought the media was overhyping it,” the respiratory therapist told me. “In retrospect, he was right to be concerned.”
He spoke to me by phone on Thursday about why, exactly, he has been so alarmed. His account has been condensed and edited for clarity.
“Reading about it in the news, I knew it was going to be bad, but we deal with the flu every year so I was thinking: Well, it’s probably not that much worse than the flu. But seeing patients with COVID-19 completely changed my perspective, and it’s a lot more frightening.”
This is knocking out what should be perfectly fit, healthy people.
“I have patients in their early 40s and, yeah, I was kind of shocked. I’m seeing people who look relatively healthy with a minimal health history, and they are completely wiped out, like they’ve been hit by a truck. This is knocking out what should be perfectly fit, healthy people. Patients will be on minimal support, on a little bit of oxygen, and then all of a sudden, they go into complete respiratory arrest, shut down and can’t breathe at all.”
They suddenly become unresponsive or go into respiratory failure.
“We have an observation unit in the hospital, and we have been admitting patients that had tested positive or are presumptive positive — these are patients that had been in contact with people who were positive. We go and check vitals on patients every four hours, and some are on a continuous cardiac monitor, so we see that their heart rate has a sudden increase or decrease, or someone goes in and sees that the patient is struggling to breathe or is unresponsive. That seems to be what happens to a lot of these patients: They suddenly become unresponsive or go into respiratory failure.”
The lung is filled with so much fluid, displacing where the air would normally be.
“It’s called acute respiratory distress syndrome, ARDS. That means the lungs are filled with fluid. And it’s notable for the way the X-ray looks: The entire lung is basically whited out from fluid. Patients with ARDS are extremely difficult to oxygenate. It has a really high mortality rate, about 40%. The way to manage it is to put a patient on a ventilator. The additional pressure helps the oxygen go into the bloodstream.
“Normally, ARDS is something that happens over time as the lungs get more and more inflamed. But with this virus, it seems like it happens overnight. When you’re healthy, your lung is made up of little balloons. Like a tree is made out of a bunch of little leaves, the lung is made of little air sacs that are called the alveoli. When you breathe in, all of those little air sacs inflate, and they have capillaries in the walls, little blood vessels. The oxygen gets from the air in the lung into the blood so it can be carried around the body.
“Typically with ARDS, the lungs become inflamed. It’s like inflammation anywhere: If you have a burn on your arm, the skin around it turns red from additional blood flow. The body is sending it additional nutrients to heal. The problem is, when that happens in your lungs, fluid and extra blood starts going to the lungs. Viruses can injure cells in the walls of the alveoli, so the fluid leaks into the alveoli. A telltale sign of ARDS in an X-ray is what’s called ‘ground glass opacity,’ like an old-fashioned ground glass privacy window in a shower. And lungs look that way because fluid is white on an X-ray, so the lung looks like white ground glass, or sometimes pure white, because the lung is filled with so much fluid, displacing where the air would normally be.”
This severity ... is usually more typical of someone who has a near drowning experience ... or people who inhale caustic gas.
“With our coronavirus patients, once they’re on ventilators, most need about the highest settings that we can do. About 90% oxygen, and 16 of PEEP, positive end-expiratory pressure, which keeps the lung inflated. This is nearly as high as I’ve ever seen. The level we’re at means we are running out of options.
“In my experience, this severity of ARDS is usually more typical of someone who has a near drowning experience — they have a bunch of dirty water in their lungs — or people who inhale caustic gas. Especially for it to have such an acute onset like that. I’ve never seen a microorganism or an infectious process cause such acute damage to the lungs so rapidly. That was what really shocked me.”
You’ll try to rip the breathing tube out because you feel it is choking you ...
“It first struck me how different it was when I saw my first coronavirus patient go bad. I was like, Holy shit, this is not the flu. Watching this relatively young guy, gasping for air, pink frothy secretions coming out of his tube and out of his mouth. The ventilator should have been doing the work of breathing but he was still gasping for air, moving his mouth, moving his body, struggling. We had to restrain him. With all the coronavirus patients, we’ve had to restrain them. They really hyperventilate, really struggle to breathe. When you’re in that mindstate of struggling to breathe and delirious with fever, you don’t know when someone is trying to help you, so you’ll try to rip the breathing tube out because you feel it is choking you, but you are drowning.
“When someone has an infection, I’m used to seeing the normal colors you’d associate with it: greens and yellows. The coronavirus patients with ARDS have been having a lot of secretions that are actually pink because they’re filled with blood cells that are leaking into their airways. They are essentially drowning in their own blood and fluids because their lungs are so full. So we’re constantly having to suction out the secretions every time we go into their rooms.”
I do not want to catch this.
“Before this, we were all joking. It’s grim humor. If you are exposed to the virus and test positive and go on quarantine, you get paid. We were all joking: I want to get the coronavirus because then I get a paid vacation from work. And once I saw these patients with it, I was like, Holy shit, I do not want to catch this and I don’t want anyone I know to catch this.
“I worked a long stretch of days last week, and I watched it go from this novelty to a serious issue. We had one or two patients at our hospital, and then five to 10 patients, and then 20 patients. Every day, the intensity kept ratcheting up. More patients, and the patients themselves are starting to get sicker and sicker. When it first started, we all had tons of equipment, tons of supplies, and as we started getting more patients, we started to run out. They had to ration supplies. At first we were trying to use one mask per patient. Then it was just: You get one mask for positive patients, another mask for everyone else. And now it’s just: You get one mask.
“I work 12-hour shifts. Right now, we are running about four times the number of ventilators than we normally have going. We have such a large volume of patients, but it’s really hard to find enough people to fill all the shifts. The caregiver-to-patient ratio has gone down, and you can’t spend as much time with each patient, you can’t adjust the vent settings as aggressively because you’re not going into the room as often. And we’re also trying to avoid going into the room as much as possible to reduce infection risk of staff and to conserve personal protective equipment.”
Even if you survive ... it can also do long-lasting damage.
“But we are trying to wean down the settings on the ventilator as much as possible, because you don’t want someone to be on the ventilator longer than they need to be. Your risk of mortality increases every day that you spend on a ventilator. The high pressures from high vent settings is pushing air into the lung and can overinflate those little balloons. They can pop. It can destroy the alveoli. Even if you survive ARDS, although some damage can heal, it can also do long-lasting damage to the lungs. They can get filled up with scar tissue. ARDS can lead to cognitive decline. Some people’s muscles waste away, and it takes them a long time to recover once they come off the ventilator.
“There is a very real possibility that we might run out of ICU beds and at that point I don’t know what happens if patients get sick and need to be intubated and put on a ventilator. Is that person going to die because we don’t have the equipment to keep them alive? What if it goes on for months and dozens of people die because we don’t have the ventilators?
“Hopefully we don’t get there, but if you only have one ventilator, and you have two patients, you’re going to have to go with the one who has a higher likelihood of surviving. And I’m afraid we’ll get to that point. I’ve heard that’s happening in Italy.”
A federal crackdown on professors' undisclosed outside activities is achieving what China has long struggled to do: spur Chinese scientists to return home.
This article was first published on Wednesday, March 18, 2020 in ProPublica.
On the fourth floor of the University of Florida cancer research building, the once-bustling laboratory overseen by professor Weihong Tan is in disarray. White lab coats are strewn over workbenches. Storage drums and boxes, including some marked with biohazard warnings, are scattered across the floor. A pink note stuck to a machine that makes copies of DNA samples indicates the device is broken.
No one is here on this weekday afternoon in February. On a shelf, wedged next to instruction manuals and binders of lab records, is a reminder of bygone glory: a group photo of Tan surrounded by more than two dozen smiling students and employees.
As the Florida lab sat vacant, a different scene unfolded half a world away in China, where a team of 300 scientists and researchers worked furiously to develop a fast, easy test for COVID-19. The leader of that timely project? Tan, the former Florida researcher.
The 59-year-old Tan is a stark example of the intellectual firepower fleeing the U.S. as a result of a Trump administration crackdown on university researchers with ties to China. Tan abruptly left Florida in 2019 during an investigation into his alleged failure to fully disclose Chinese academic appointments and funding. He moved to Hunan University in south-central China, where he now conducts his vital research.
Tan, a chemistry professor whose research has focused on diagnosing and treating cancer, quickly pivoted to working on a coronavirus test when the outbreak began in China. Boosted by a Chinese government grant, he teamed up with researchers at two other universities in China and a biotechnology company to create a test that produces results in 40 minutes and can be performed in a doctor's office or in non-medical settings like airport screening areas, according to a 13-page booklet detailing the test's development and benefits. It has been tried successfully on more than 200 samples from hospitals and checkpoints, according to the booklet, which Tan shared with a former Florida colleague. It's not clear how widely the test is being used in China.
Epidemiologists say that testing is vital to mitigate the spread of the virus. But the U.S. has lagged well behind China, South Korea, and Italy in the number of people tested. It's hard to know if Tan's test would have made a difference. The slow U.S. ramp-up has been blamed largely on bureaucratic barriers and a shortage of chemical agents needed for testing.
A star researcher funded by the National Institutes of Health, Tan taught for a quarter century at Florida and raised two sons in Gainesville. He was also a participant in the Thousand Talents program, China's aggressive effort to lure top scientists from U.S. universities, and had been working part time at Hunan University for even longer than he had taught at Florida. Last year, alerted by NIH, Florida began investigating his outside activities.
Tan declined to answer questions about his departure from Floria or his new test, but he provided documentation that his department chairman at Florida was "supportive" of his research in China as recently as 2015. He is one of three University of Florida researchers — along with others from the University of Texas MD Anderson Cancer Center and the University of Louisville — who relocated to China while under investigation for allegedly hiding Chinese funding or affiliations with universities there.
Such nondisclosure may well be pervasive. A ProPublica analysis found more than 20 previously unreported examples of Thousand Talents professors who appear not to have fully revealed their moonlighting in China to their U.S. universities or NIH.
NIH has contacted 84 institutions regarding 180 scientists whom it suspects of hiding outside activities or funding, and it has referred 27 of them for federal investigation, said Michael Lauer, the agency's deputy director for extramural research. "There's no reason why the U.S. government should be funding scientists who are engaged in unethical behavior. It doesn't matter how brilliant they are," said Lauer, who declined to discuss specific professors under scrutiny. "If they don't have integrity, we can't trust them for anything. How can we be sure that the data they're producing is accurate?"
Yet the government's investigations and prosecutions of scientists for nondisclosure — a violation previously handled within universities and often regarded as minor — may prove counterproductive. The exodus of Tan and his colleagues highlights a disturbing irony about the U.S. crackdown; it is unwittingly helping China achieve a long-frustrated goal of luring back top scientific talent.
Thousand Talents aimed to reverse China's brain drain to the West by offering elite Chinese scientists premier salaries and lab facilities to return home permanently. Finding relatively few takers, it let participants like Tan keep their U.S. jobs and work in China on the side.
By investigating Tan and other Chinese researchers for nondisclosure, the U.S. government is accomplishing what Thousand Talents has struggled to do. None of the professors identified in this article have been charged with stealing or inappropriately sharing intellectual property. Yet in the name of safeguarding American science, federal agencies are driving out innovators, who will then make their discoveries and insights in China instead of the U.S. The potential drawbacks hark back to an episode in the McCarthy era, when a brilliant rocket scientist at the California Institute of Technology was deported by the U.S. for supposed Communist sympathies and became the father of China's missile program.
John Brown, the FBI's assistant director of counterintelligence, toldthe U.S. Senate in November that participants in Thousand Talents and other Chinese talent programs "are often incentivized to transfer to China the research they conduct in the United States, as well as other proprietary information to which they can gain access, and remain a significant threat to the United States."
A spokesperson for the Chinese Embassy in Washington, D.C., disputed such characterizations. "The purpose of China's 'Thousand Talents Plan' is to promote talent flow between China and other countries and to galvanize international cooperation in scientific and technological innovation," Fang Hong said. While firmly opposing any "breach of scientific integrity or ethics … we also condemn the attempt to describe the behaviors of individual researchers" as "systematic" intellectual property theft by the Chinese government. "It is extremely irresponsible and ill-intentioned to link individual behaviors to China's talent plan."
Steven Pei, a University of Houston physics professor and former chair of the advocacy group United Chinese Americans, said that both countries have gone too far. "The Chinese government overreached and the American government overreacted," Pei said. "China tried to recruit but it was unsuccessful. Now we help them do what they cannot do on their own."
Pei added that U.S. universities are failing to protect their Chinese faculty: "When the pressure comes down, they throw the researchers under the bus."
NIH has long viewed collaborations with China as a boon for biomedical research, even initiatinga formal partnership with China's National Natural Science Foundation in 2010. But it became concerned in 2016 when it learned from the FBI that an Asian faculty member at MD Anderson had shared federal grant proposals he was reviewing with researchers at other institutions — a violation of NIH rules.
Examining the grant applications of its federally funded researchers, NIH found many undisclosed foreign ties, particularly with research institutions in China. Some researchers were accepting dual appointments at Chinese universities and publishing results of U.S.-funded research under their foreign affiliation. Often, these foreign positions were not reported to the NIH or even the researchers' own American universities.
In August 2018, the NIH launched aninvestigation to ensure that its researchers weren't "double dipping" by receiving foreign funds for NIH-funded work or diverting intellectual property produced by federally backed research to other countries. The NIH found at least 75 researchers with ties to foreign talent programs who were also responsible for reviewing grant proposals. In some cases, Lauer said, Thousand Talents scientists with access as peer reviewers to confidential grant applications have downloaded them and emailed them to China. Other researchers have disclosed consulting or teaching in China but haven't acknowledged that they've signed an employment contract with a Chinese university or are heading a lab, he said. NIH gave the names of "individuals of possible concern" to the researchers' institutions but did not make them public.
To gauge the extent of the problem, ProPublica matched Thousand Talents recipients identified on Chinese-language websites with their disclosures to their universities and grant applications to NIH, which we obtained through public records requests. We found at least 14 researchers who apparently did not disclose foreign affiliations to their U.S. universities, which included the University of Wisconsin, Stony Brook University and Louisiana State University. We couldn't determine if these researchers were also on NIH's confidential list.
Of 23 Thousand Talents recipients in our survey who have sought NIH funding, none reported conflicts of interest with Chinese universities to the agency. Just three revealed these positions in the bio sections of their grant applications. Because NIH redacted foreign funding from the applications it provided to us, citing personal privacy restrictions, we couldn't tell if the researchers reported any grants from institutions in China.
It's not always easy to define or prosecute theft of intellectual property in academia, especially if the research is considered basic and doesn't require a security clearance. Unlike corporations that protect trade secrets, universities see science as an open, global enterprise and promote international collaborations. Practices such as photographing another research team's specially designed lab equipment may be considered unethical by some, but they aren't necessarily unlawful. Thus the U.S. government is trying to clamp down on suspected intellectual property theft by targeting nondisclosure.
Yet the link between hiding Thousand Talents affiliations and stealing research secrets may be tenuous. Universities bear some responsibility for the nondisclosure, because they are supposed to certify the accuracy of information supplied to NIH. Until recently, many schools were lax in enforcing disclosure rules. "It's fair to say, at some universities, they have not really been paying attention to how their faculty spend their time," Lauer said. One professor was away for 150 days a year and the university didn't notice, he said.
Non-Chinese scientists, including doctors paid by pharmaceutical , also underreported outside income. Nor did universities want to restrict partnerships with Chinese universities; in the prevailing culture of globalization, they encouraged foreign collaborations and sought to open branches in China to boost their international prestige and attract outstanding, full-tuition-paying students.
Now times have changed, and Chinese scientists at U.S. universities are trapped in the backwash. Even those who rejected overtures from China have been hounded. Xifeng Wu, an epidemiological researcher, worked at MD Anderson for nearly three decades and amassedan enormous dataset to help cancer researchers understand patient histories. She twice turned down invitations to join Thousand Talents. But she collaborated with and accepted honorary positions at research institutions in China, where she grew up and attended medical school. Although she said she earned no income from these posts, NIH identified her as a concern, and MD Anderson found that she did not always fully disclose her Chinese affiliations.
In early 2019, she left MD Anderson — one of at least four researchers who were pushed out of the center in the wake of the federal investigations. She has become deanof the School of Public Health, with a well-equipped laboratory, at Zhejiang University in southeast China.
Dong Liang, Wu's husband and the chair of the pharmaceutical and environmental health sciences department at Texas Southern University, felt that MD Anderson buckled under pressure from NIH, which provided the institution with more than $145 million in federal grants in 2018.
"A few years back, they wanted the collaborations [with China]," said Liang. "And now, they take it back." The disclosure rules, said Liang, weren't clear, "and now it becomes a violation."
Professors who were in the process of being fired could have exercised their rights to a hearing before a faculty panel as well as "several rounds of peer discussions," but they instead left "on their own volition," MD Anderson spokeswoman Brette Peyton said. "As the recipient of significant NIH funding," MD Anderson had a responsibility to follow up on the agency's concerns, or risk losing federal money, she said.
Baylor College of Medicine in Houston took a less punitive approach than MD Anderson. When NIH alerted the Baylor College of Medicine that at least four researchers there — all ethnically Chinese — erred in their disclosures, Baylor corrected the documents and allowed them to continue working.
China began sending students to the U.S. in the late 1970s in the hope that they would return with American know-how and foster China's technological prowess. But, especially after the Tiananmen Square massacre in 1989, many of the students stayed in the U.S. after earning their degrees.
The Chinese government has been the most assertive government in the world in introducing policies targeted at triggering a reverse brain drain.
Established in 2008, Thousand Talents was intended to lure prominent scientists of Chinese ethnicity under age 55 back to China for at least half the year with generous salaries and research funds and facilities, as well as perks such as housing, medical care, jobs for spouses and schools for children. Some Thousand Talents employment contracts require members to sign nondisclosure agreements related to their research and employment with Chinese institutions, according to a November 2019 report by the U.S. Senate's Permanent Subcommittee on Investigations.
"The Chinese government has been the most assertive government in the world in introducing policies targeted at triggering a reverse brain drain," David Zweig, a professor at Hong Kong University of Science and Technology, and Huiyao Wang, director general of the Center for China and Globalization in Beijing, wrote in 2012.
The program succeeded in attracting 7,000 foreign scientists and researchers as of 2017, the Senate subcommittee reported. But it had trouble enticing professors at elite U.S. universities, who were reluctant to uproot their families and leave their tenured sinecures. It created a second tier for recruits who were "essentially unwilling to return full-time," Zweig and Wang wrote. They could keep their U.S. jobs and come to China for a month or two. Complaints arose in China about "fake returnees" who "work nominally in China for six months" but "in fact, most of them are still abroad," according to a 2014 op-ed on the BBC News Chinese website.
Scandals marred the program's reputation in the U.S. In 2014, Ohio State contactedthe FBI about engineering professor Rongxing Li, who had fled to China. Li, a Thousand Talents member, allegedly had access to restricted NASA information. The U.S. attorney's office did not bring charges against Li, who is teaching at Tongji University in Shanghai. Another Thousand Talents member, Kang Zhang, a professor of ophthalmology at the University of California, San Diego, resigned last year after reportsthat he failed to disclosebeing the primary shareholder of a Chinese company whose focus overlapped with his UC research. No charges were filed against Zhang, now a professor at Macau University of Science and Technology.
Struggling to attract top researchers, Thousand Talents also reached out to non-Chinese scientists, like Charles Lieber, the Harvard chemistry chairman charged in January with making false statements to the U.S. government by denying his involvement with Thousand Talents and with Wuhan University of Technology. His three-year Thousand Talents contract called for Wuhan to pay Lieber $50,000 a month plus more than $1.5 million for a research lab, according to the Department of Justice. Lieber has not yet entered a plea. His attorney, Peter Levitt, declined comment.
"In the last five years, there has been a definite deliberate move toward targeting non-ethnic Chinese," said Frank Figliuzzi, former FBI assistant director for counterintelligence. "They've been getting so many rejections from their own people who don't want to go back home and have fallen in love with their Western culture and their life. Or their wife won't go back. Or their kids won't go back.
"The other thing that we've seen, which I think is very troubling, 'Hey, you don't have to come back home full time.' In the intel community, we call that a RIP, recruitment in place."
Staying in the U.S. meant that Thousand Talents recipients had to report their Chinese positions to their American universities. Some didn't. Richard Hsung, a professor of pharmaceutical sciences at the University of Wisconsin, affirmed annually on disclosure forms that he had "no reportable outside activities." He acknowledged in an interview that, from 2010 to 2013, he was in Thousand Talents and worked part time as a visiting professor at Tianjin University, which has 25,000 students and is 70 miles southeast of Beijing.
He said that he didn't mention the Tianjin position because the disclosure forms confused him. He includes "National Thousand Talent Distinguished Visiting Professor at Tianjin University" among his honors on the faculty website. "I was not flaunting it, but I was not hiding it," he said.
His stints in China helped the University of Wisconsin, he said. "When there's an opportunity such as this one, you take it, it expands the visibility, it expands interacting with more students in training, and they come here to help us."
Also unreported was Hsung's relationship with a biotech company in Shanghai. In corporate records, Shanghai Fangnan Biological Technology Co. says that it "was founded by the national 'Thousand Talents Plan' specially invited experts," and it names Hsung as a director. Hsung said he was unaware of being listed as a board member and is asking the company to remove his name. He has consulted for the company "from time to time" but is compensated for expenses only, he said. "I have not been involved in any of their projects nor have they supported my research here," he added in an email.
When there's an opportunity such as this one, you take it, it expands the visibility, it expands interacting with more students in training, and they come here to help us.
Richard Hsung, professor of pharmaceutical sciences
University of Wisconsin spokeswoman Meredith McGlone said that Hsung should have reported his job at Tianjin on outside activities forms, as well as an "unexpected honorarium of less than $5,000" from the Shanghai biotech firm. He has since updated his disclosure form to reflect the honorarium, she said. While the university has no "uniform penalty" for nondisclosure, she said, the appropriate response in cases, like Hsung's, where there is no "evidence of intent to mislead" would be "additional training and perhaps a letter to the personnel file."
The university convened a working group last year to "consider policies and practices intended to bolster security without sacrificing the free exchange of ideas," McGlone said. It then added a question to the disclosure form: "Do you have an ongoing relationship with a foreign research institute or foreign entity?"
Each year, the University of Florida's chemistry department evaluates its 40 or so faculty members by criteria that include amounts raised for research funding and the number and impact of studies published. Weihong Tan, who joined the department in 1996, was usually ranked among the top three professors every year, said a department official who asked not to be identified.
Tan's research group developed a new way of generating molecules that bind to targeted cells, as a possible approach to identifying and treating cancers. He collaborated with researchers in other departments and became close with top deans and research officials on campus. He was popular with students. Each week, dozens of graduate and postgraduate researchers lined up in the hall outside his office, waiting to meet with him. He also won prestigious chemistry awards and developed an international reputation.
While at Florida, Tan maintained a co\nnection to Hunan University in China, where he studied as an undergraduate. His curriculum vitae states he was an adjunct professor at the school from 1993 through at least 2019, when he left Florida. The part-time teaching job is the CV's only reference to any professional work in China.
In his annual disclosures to Florida, Tan did report positions and income in China, but not everything alleged by university investigators. In 2017, he said he was working 10 hours a week at Hunan for a salary of $30,000. In 2018, he said his hours had doubled to 20 a week, for $50,000. In 2019, he reported working a total of 20 hours a week for Hunan and the Institute of Molecular Medicine at Renji Hospital in Shanghai. His combined pay from the positions was $120,000, according to his form.
The association with Hunan began during a gap in Tan's resume — between receiving a 1992 doctoral degree from the University of Michigan and starting postdoctoral work in 1994 at the U.S. Department of Energy's Ames Laboratory.
In recent years, according to colleagues, Tan's work in China intensified. He was making frequent trips there, sometimes traveling twice a month from Gainesville, one said. Tan told colleagues that his research in China complemented his Florida work, and that it was easier to conduct testing on people in China than in the U.S. His research in Florida focused on basic science testing that didn't involve patients.
Tan knew his increasing workload in China was putting a strain on his full-time position in the U.S. He told a colleague he was considering asking for a leave of absence from Florida. It's unclear if he did request a leave.
In January 2019, the NIH notified Florida that Tan might have undisclosed affiliations with foreign institutions as well as foreign research funding. The university then launched its own inquiry. It provided investigator notes regarding Tan and two other researchers allegedly involved in Chinese talent programs to a special state legislative committee reviewing foreign influence on publicly funded research. Those notes do not name the faculty members under investigation, instead referring to them by numbers such as "faculty 1." The details for faculty 1 — including date of hire, area of research, department and Chinese affiliations — match those of Tan.
Faculty members two and three appear to be Lin Yang, an NIH-funded professor of biomedical engineering, and Chen Ling, an up-and-coming pediatric cancer researcher.
Florida hired Yang from the University of Kentucky in 2014 as part of a "Preeminence Initiative" to boost its ranking among public universities. Yang traveled to Beijing for a Thousand Talents interview in 2016, according to the university's investigative notes. The following year, he was selected for the program at a Chinese university.
The effect of this is universities are bleeding good people.
Peg O'Connor, attorney for Lin Yang, ex-Florida professor of biomedical engineering
Yang resigned his Florida position last year after the university began looking into his alleged failure to disclose his association with China's Thousand Talents program. University investigators also allege that he hid being chief executive, founder and owner of an unidentified China-based company.
In an email, Yang said he disputes many of Florida's findings. He said he applied for a talent program but then turned it down. He said he never had any foreign grants or academic appointments in China while employed by Florida. Yang's attorney, Peg O'Connor, said the University of Florida began a push in 2010 to encourage overseas collaborations. "To be punished for doing what the university called on you to do doesn't make sense to me," she said. "The effect of this is universities are bleeding good people."
Ling, a part-time research associate professor, won multiple grants to study gene therapy techniques that target the most common pediatric liver cancer. "Early in a very promising career, Ling is already making great strides in the development of innovative therapies for cancer," the chairman of the medical school's pediatrics department said in a 2012 press release.
Ling left Florida last year. The university investigative notes that appear to refer to Lin allege that he failed to inform NIH that he was participating in a Chinese government sponsored talent program, and that he received an unreported research grant from a Chinese foundation.
However, Ling did report working at Fudan University in Shanghai to University of Florida officials in 2018. His disclosure, which can be viewed at ProPublica's Dollars for Profs site, shows that Fudan paid him $53,732 for activities that included "establishing a regular molecular biological laboratory, conducting gene therapy research, teaching curriculum, publishing manuscripts." He indicated that the activity would require eight months of work each year. It's unclear if Florida officials relayed this information to NIH.
Ling, who did not respond to emails seeking comment, is continuing his research as a professor at Fudan. A former Florida colleague described him as "very smart" but somewhat naive in dealing with conflict of interest issues. "I don't think he did anything with malicious intent," said the colleague. "He paid a heavy price for this."
Mengsheng Qiu, a neurobiologist at the University of Louisville, not only disclosed a part-time position in China to his department, but he even accepted a pay cut at Louisville to offset his foreign income. Nevertheless, NIH targeted him.
Qiu, 56, received his bachelor's and master's degrees in China and his doctorate from the University of Iowa in 1992. After spending five years as a postdoctoral fellow at the University of California, he joined the Louisville faculty in 1997 and was tenured in 2001.
Qiu has received several NIH grants over the past two decades. Fred Roisen, the department's former chair, described Qiu as an excellent and dedicated researcher. "He had a very active lab that published extensively," Roisen said. "His students were highly sought after for postdocs at all the best schools in the U.S. Some were Chinese and some were not. I could only give him the highest recommendation. His lab, if I went in Saturday and Sunday, there were always people working there."
Qiu joined the Thousand Talents program in 2009, taking a part-time job at Hangzhou Normal University, which announced that it had hired him as its first scholar "under a high-level creative talents program" that aimed to "attract elites from all walks of life at home and abroad." Someone at Hangzhou sent the announcement to Louisville administrators, who did not know that Qiu was seeking a position in China and were taken aback, according to a friend of Qiu's. The friend said that Qiu had not informed Louisville because terms of the Hangzhou job were still being negotiated.
I just knew he had access to a lab in China. I never had a negative thought connected with him whatsoever.
Fred Roisen, former department chair, University of Louisville
Louisville and Qiu then agreed to reduce his salary to compensate for his time in China. "We negotiated a pay cut that was proportional to the time he was away," Roisen said. "If he was taking two months off, that was two months' pay you don't get."
Roisen said he didn't know about Qiu's participation in the Thousand Talents program. "I just knew he had access to a lab in China. I never had a negative thought connected with him whatsoever." By working in China, Qiu "was trying to get additional help for projects," Roisen said. "Some tissues were not readily available in the U.S." The current chair, William Guido, declined comment.
His wife, Ling Qiu, said that each time Qiu visited China, he received the university's approval. "They wanted him to report everything," she said. "He said, 'I did.' Every time I go to China, I tell you."
"He is a good citizen," she said. "He does not even use a coupon if it is expired." Thousand Talents paid for his travel to China and his work there, she said, but it wasn't big money. "I wish," she said. She added in an email, "He did not do anything wrong but I don't know the details about his research activity."
In recent years, a Louisville colleague said, Qiu had a "lag" in federal funding, and NIH turned down one of his grant applications. "I suspect, and we all felt, that this might have been due to him putting a lot of emphasis on his Chinese involvement in those laboratories and less here," the colleague said.
The colleague added that at Qiu's most recent career review, "We did think it was interesting he managed to publish 17 papers in the previous five years, some in prestigious journals, with such a small laboratory. I think some of it was done in China. That might be why they're looking into it."
People close to Qiu said that the probe has been going on at least since the summer of 2019, and that he met for half a day on campus with investigators. University of Louisville spokesman John Karman III declined comment, citing "an ongoing investigation involving this former faculty member." Also citing the investigation, Louisville declined to provide any outside activity forms that Qiu submitted to the university.
Last December, Qiu retired from Louisville. He's now head of the Life Science Research Institute at Hangzhou Normal University. Friends said that he preferred working in China because he helped set up the institute there and the lab conditions and students were better than at Louisville. He felt unjustly overshadowed at Louisville by more prominent Ivy Leaguers in his field. When Hangzhou Normal renewed Qiu's 10-year appointment in 2019, a friend said, it asked him to become full-time, forcing him to choose between China and Louisville. "He must have balanced the two," the friend said. "Finally, he came up with a choice."
Qiu's wife, a doctor who was in private practice in the U.S., said that the investigation drove him out. It made him "very, very depressed," she said. He told her that it reminded him of China's persecution of intellectuals during the Cultural Revolution. "They sent me an email and asked me a bunch of questions," he told her. "Maybe I go to jail."
Qiu declined comment through his wife. She said in a February email that he was quarantined at home in Hangzhou because of the coronavirus, while she was fighting the epidemic at an international hospital in Shanghai. "We try to comfort each other by phone or video chat," she said. "We are not able to see each other since my job is high risk."
In 2015, when Weihong Tan was up for election to the Chinese National Academy of Sciences, his chemistry chairman at the University of Florida recommended him and lauded his ongoing research in China.
"We are very happy to see his great success at Hunan University in research and education," William Dolbier wrote in the letter provided by Tan. "We are very supportive of his research and educational activities there."
Tan's positions were also publicly listed on the web before NIH notified the University of Florida that there might be an issue.
The English language website of Hunan University, beginning in at least March 2018, listed Tan as a vice president and director of a chemistry lab. According to the site, Tan had run the lab since 2010 and had been a vice president of the school since August 2017. The school also indicated Tan was a full professor there and supervised doctoral students. Tan appeared in an English-language video in 2017 to promote a textbook he edited and described himself as a distinguished professor of chemistry at both Florida and Hunan.
On several occasions, Hunan University publicly lauded Tan. In 2017, when he was named an associate editor of the Journal of American Chemical Society, both the University of Florida and Hunan University put out press releases announcing the appointment. Florida officials at the time were apparently unaware of Tan's positions in China, and the school's release makes no mention of them. Hunan, on the other hand, lists his position in Florida.
Tan was also named an "honored professor" in 2017 at the East China University of Science and Technology. A story about a ceremony marking the appointment on that university's website includes photographs of Tan touring school labs and meeting with faculty. It lists him as holding several academic posts in China as well as his University of Florida professorship.
After NIH notified Florida at the beginning of 2019 about a potential problem with Tan, the university's office of research began reviewing Tan's emails. In correspondence, Tan acknowledged his Hunan jobs, according to the notes. He also allegedly used his Florida email account to conduct Hunan business.
The investigators found evidence that Tan had significant ties to Chinese government-sponsored talent programs and helped recruit U.S. researchers to those programs. The emails also indicated Tan received at least four research grants from Chinese government programs and didn't tell the NIH about them. Of all of Tan's extensive university and government ties with China, the only item he appears to have disclosed to the NIH and Florida was an adjunct teaching position at Hunan.
When Tan suddenly resigned his position in Florida last year, he told colleagues he was going to work full time in China but was vague about the reasons for leaving after almost a quarter century on campus. Administrators scrambled to find new mentors for the more than dozen graduate and postgraduate students working in his two labs on campus. The move was so abrupt that Tan's wife stayed behind in Gainesville, according to colleagues.
Tan didn't answer questions sent to him by email, although he did acknowledge receiving them. A federal investigation of Tan's relationships in China is ongoing, according to the investigative summary provided by the university to state legislators.
The University of Florida said in a statement that it has taken steps to prevent other professors from joining Thousand Talents and concealing foreign positions. As a result of a new risk assessment process for detecting foreign influence that it introduced in 2018, it said, Florida is denying most requests from faculty to participate in foreign talent programs.
The university said it "maintains a robust and vigilant program to safeguard our technology and intellectual property from undue foreign influence, and to extend appropriate oversight to UF activities (and those of its faculty members) in connection with foreign organizations." A spokesman declined to answer questions about individual professors, citing ongoing investigations.
William Dolbier, the former chemistry chairman at Florida and now an emeritus professor, said Tan's departure could have been avoided if he had disclosed all of his work in China. "He was not a money guy," Dolbier said. "He was not out to steal from the United States. The development of these drugs was his primary focus and goal." Dolbier added that Tan told him he would be glad to try to make his COVID-19 test available in the U.S.
There's a pandemic spreading across the U.S., and amid ongoing struggles to scale up testing, it's still unclear how many people are actually infected.
In the absence of real numbers, projections have filled the void, and I've been struggling as a reporter to know which forecasts to trust. Last week, the Ohio Department of Health said that over 100,000 people were infected, at a time when there were five confirmed cases in the state. Some epidemiology experts critiqued that estimate as too high, and the department's director later said she was "guesstimating."
Should reporters second-guess their health department's figures? When is it safe for me to retweet? I set out to talk to some experts and learned just how fuzzy those forecasts can be. But there are ways we can think about them that help give us more clarity.
It's impossible to know how many people are infected right now. Just know that the number is far higher than the running case count.
It's easier to do big, sweeping projections on a question like how many people will be infected by the time this is all over and done with. Marc Lipsitch, head of the Harvard T.H. Chan School of Public Health's Center for Communicable Disease Dynamics, has been running projections to figure out how many adults across the world will be infected before a vaccine hits the market (one won't be available for at least a year) or herd immunity kicks in — when enough people have developed immunity to the virus, from having caught it, so that it can't easily be transmitted any more. He concluded that between 20% and 60% of adults worldwide will ultimately get infected. (ProPublica has created a tool based on his models and it's worth checking out.)
It's much harder to figure out how many Americans are infected at this very moment. Some states have little information because they've barely started testing and don't know when community transmission began in specific places. Many people with symptoms consistent with COVID-19 were turned away from getting tests.
Caitlin Rivers, a computational epidemiologist at Johns Hopkins Center for Health Security, said she's "not sure we're in a place where we're able to estimate that," though she's confident that there are far more infected people than the number of reported cases at this time. Computational epidemiologist Maia Majumder said that without widespread testing, this is a "really challenging question to pin down."
In short, the best way to actually know is with hard evidence — which means testing. As World Health Organization director general Tedros Adhanom Ghebreyesus saidon Monday: "You cannot fight a fire blindfolded, and we cannot stop this pandemic if we don't know who is infected. We have a simple message for all countries: Test, test, test."
Think in orders of magnitude. The numbers are less precise than they seem.
Of course, computational epidemiologists do have ways of coming up with ballpark estimates. I asked the experts to discuss this sentence with me, from a March 14 postabout New York City's looming crisis by a Facebook data scientist:
"We estimate that between 1,281 and 2,280 people are infected as of yesterday."
That range seems to be both wide yet oddly specific. What is a reader supposed to take away from a sentence like that?
Reporting precise numbers allows epidemiologists to replicate each others' work; rerunning the same equations and arriving at the same results helps to validate findings. Public health officials also need as much information as possible because it's helpful for decision-making about preparing hospital beds or closing schools.
My concern, however, is that a sentence like that can give readers a false sense of precision, as if it's possible to know down to a difference of one or two people. When I asked Rivers what a regular person should take from these counts, she said people should focus on the order of magnitude: "This means there's a couple of thousand people, it's not 200 or 4 million. It means we're in the low thousands."
"If the forecast doesn't state its assumptions, I'd be wary," Majumder said. For example, a popular modeling approach, called the SIR model, assumes that each individual is equally likely to come into contact with any other individual in the population; you don't have to have a Ph.D. to see how that's not very realistic.
Majumder also noted that just because someone is good at math doesn't mean that they're equipped to do epidemiological forecasting, which comes with its own nuances. "Has the author published epidemiological modeling studies – preferably of other emerging infectious diseases – before in peer-reviewed literature?"
My advice: Check who the numbers are coming from before repeating them.
Don't get hung up on the specifics. The big picture is clear.
Trying to get clarity on exactly how many people are infected in your city shouldn't be your goal, if you're a regular member of the public. Rivers and Majumder agreed on this: There's no difference in what action you need to take, whether the models say there will be 10,000 or 20,000 infections in your state within a certain number of days or weeks.
There isn't a single expert I've talked to who said case counts won't continue to soar. There are two reasons for this: As testing becomes more available, cases that already exist will be revealed. Secondly, of course, the virus is continuing to spread. The trends are crystal clear, and the call to action is indisputable. "If your state has reported community transmission, the message is the same no matter the number of cases: engage in social distancing immediately," Majumder said.
Public health experts agree that Americans need to stay home as much as possible, but the Trump administration has not yet issued clear guidance to federal workers.
In some ways, the United States is lucky, because the disease arrived here later than it did in China or Italy. We don't need to rely on computer models to guess what we have to do. We can look to other countries that have been dealing with the virus longer than us.
Rivers points to some countries in Asia that have taken sweeping measures, including closing schools, testing en masse and even publishingthe past whereabouts (without names) of people who tested positive, as in South Korea — from the restaurants people visited to the specific seats they sat in at movie theaters.
"They took these interventions really seriously and were really committed in order to avoid a scenario like Italy," she said. "That's really what we should be focusing on as a country."
For reporters, this means two things: Of course, we should continue to ask public officials to explain where they get their numbers from and run them by experts before publication whenever possible. But more crucially, the press needs to hold those in power accountable for their actions — or lack thereof. While it's forgivable to put out a bad estimate, it's unforgivable to not act in the face of a pandemic that is not just at our doorstep, but already inside our house.
Each of us has the power to help flatten the curve.
I'm sure by now you've already heard about this notion, which comes with its own hashtag. In a nutshell, to avoid a spike of critical cases that will overload our hospitals, we need to implement mitigation strategies to slow down disease transmission.
For the past week, my email inbox has been a sea of panic. A woman in California wrote that she is the full-time caregiver for her elderly mother and is terrified of infecting her. Should she wear gloves at all times, even to touch the mail? Should she never leave the house? A New England retail worker described her fear while ringing people up all day, but said: "I need the money for my bills. I don't know what to do." A hospital administrator trying to secure supplies for her facility told me: "I can't lose my job. I can't lose my life insurance. If I die, I need my child taken care of."
How soon regions run out of hospital beds depends on how fast the novel coronavirus spreads and how many open beds they had to begin with. Here's a look at the whole country. You can also search for your region.
On Saturday night, after reading too many of these messages in one go, I cried, knowing there was so little I could do to actually help and feeling overwhelmed by how large the problem felt.
But the next morning, I woke up to Berlin-based reporter Kai Kupferschmidt's suggestion that we all share "positive or practical things" that we'd seen or done, big or small, "to adapt to this new world we find ourselves in." For the first time in a while, bright spots illuminated my computer screen. A member of my book club emailed everyone offering to help buy food and supplies. Dr. Esther Choo, an associate professor of emergency medicine, tweeted: "Medical students around the country, taken off clinical rotations due to #COVID, have set up babysitting networks to support essential hospital staff." All these stories cheered me immensely and encouraged me that I didn't have to sit back helplessly; I could take small actions myself.
When forecast figures are being thrown around — thousands and hundreds of thousands and millions of people — it can be hard for them to feel real. But when I remind myself that all these fearful and anxious and generous and compassionate people are who we're all fighting for, it's a no-brainer as to why I should stay at home, even if I am young and healthy.
The curve will certainly rise for the next few weeks. There will be more fear-inducing headlines that give us reason to doubt the level of preparedness. But know that our individual actions — staying home, enabling health care workers by not hoarding supplies like masks, doing what we can to take care of the most vulnerable in our society — can all help flatten that curve. I hope that our collective efforts mean that it will not rise for too long, and it will not be too steep. In the meantime, take care, and be well.
A federal directive that's supposed to speed up the response to a pandemic is actually slowing down the government's rollout of coronavirus tests.
The directive, issued by the U.S. Food and Drug Administration, requires that the Centers for Disease Control and Prevention, a sister agency, retest every positive coronavirus test run by a public health lab to confirm its accuracy. The result, experts say, is wasting limited resources at a time when thousands of Americans are waiting in line to get tested for COVID-19.
The duplicative effort is the latest obstacle that is slowing the federal response to COVID-19, which has infected more than 1,300 people and resulted in 38 deaths in the United States. Progress was already delayed because the CDC decided to make its own test rather than adopting the design endorsed by the World Health Organization. The test then didn't work properly and had to be fixed. The problems were further compounded by delays in certifying tests by private laboratories as well as a shortage of supplies and raw materials used for testing.
On Feb. 4, the FDA, which regulates devices as well as drugs, released a document called an Emergency Use Authorization to govern the use of the test. The goal of the emergency authorization is to short-circuit the typically onerous regulatory review that the agency imposes on new diagnostic devices — a process that can take months to years.
In the face of an imminent outbreak, however, the stringently written EUA appears to have become more of a hindrance than a help. Because of the requirement that the CDC rerun tests conducted by public health labs, as of two weeks ago the CDC's website was lagging in its tally because it was only reporting confirmed cases. The CDC is now reporting both presumptive positives, which have been tested only by local labs, as well as cases it has confirmed.
"This is the time when we need as many tests as we can very quickly, because we need to know what is happening in this country," said Dr. Leana Wen, an emergency physician and former health commissioner for the city of Baltimore. "Right now we are in the dark about the degree of COVID-19 spread. It's hard for us to proceed to do our work in public health without concrete information."
The CDC says it is simply following the process set out by federal regulations, though it couldn't say how many false positives, if any, have shown up in the verification process.
"The regulatory language of the EUA dictated that," CDC spokesman Richard Quartarone said. "We have to follow the rules. If we don't follow the rules, FDA could shut us down. That is a real thing."
The CDC is designed to serve as a short-term bridge to widespread testing while it analyzes a new disease and makes sure diagnostic tests are working correctly before handing the role off to the private sector, Quartarone said. If duplication hadn't been required, the CDC may have been able to help with more front-line testing before private-sector labs took over, he said.
The emergency authorization also slowed the process of tests offered by private labs, which became available last week. The FDA initially required private labs to copy the CDC's test design and have the agency review their tests before allowing them to begin testing. It took more than three weeks and growing criticism for the FDA to update its guidelines to allow certain academic labs to start testing once they had validated their tests internally.
In response to questions, FDA spokeswoman Stephanie Caccomo referred a reporter to a speech by FDA Commissioner Stephen Hahn on March 7, in which he defended the agency's process.
"In the U.S., we have policies in place that strike the right balance during public health emergencies of ensuring critical independent review by the scientific and public health experts and timely test availability," Hahn said. "The CDC test is a high-quality test, and it's important to remember that false negatives or positives can be detrimental to making sure we are treating patients early, without delay, and also not quarantining healthy individuals."
Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins' School of Public Health, said the FDA's high standards might have been appropriate for smaller outbreaks. The FDA issued EUAs for diagnostics during the 2014 Ebola crisis and in 2016 for the mosquito-borne Zika virus. The coronavirus, however, is moving too fast to maintain absolute control — and the FDA could have ordered up a more flexible process, Scharfstein said.
"If you were to go back in time and tell the FDA 'you've got a month to get a million tests ready,' I imagine they wouldn't have chosen this strategy," said Sharfstein, who oversaw EUAs while he served as deputy commissioner of the FDA during the Obama administration.
The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn't trust the test's accuracy.
Requiring confirmatory tests not only adds time to the process but also uses crucial chemicals needed to set up the tests. "You need some of the reagents that now are in short supply to prepare the tests," said CDC Director Robert Redfield in ahearing before the House Oversight Committee on Thursday, explaining the difficulty in expanding capacity even as private labs received green lights to start testing.
Private labs need only get confirmation for their first five positive and first five negative clinical specimens, according to the FDA's Feb. 29 guidance. Commercial giants like LabCorp and Quest Diagnostics say they are now able to run thousands of tests a day.
"We want them to come online, because we don't have the manufacturing capacity; our system in place is not designed for that massive amount," Quartarone said of the private labs. "In general, CDC testing is a drop in the bucket for the overall testing that happens."
According to the American Enterprise Institute, as of Thursday afternoon, nationwide testing capacity was at about 20,695 people a day. California public and private labs accounted for 39% of capacity, and the CDC and public health labs together accounted for about 17% of available tests.
That's only testing capacity, however. According to Redfield, actual testing is still hampered by shortages of essential equipment and manpower.
An outbreak would demand peak performance from America's medical professionals — especially in hospitals. But many of the facilities that may be on the front lines have well-documented histories of failing to prevent the spread of infectious diseases.
This article was first published on Tuesday, March 3, 2020 in ProPublica.
In early February, Royal Caribbean's Anthem of the Seas docked in Bayonne, New Jersey, in need of a hospital. The cruise ship was carrying patients who had traveled from China, where an outbreak of COVID-19 had taken root. Four passengers needed to go somewhere for further medical observation.
The obvious next step was University Hospital in Newark, a major academic medical center equipped with isolation rooms. "The hospital is following proper infection control protocols while evaluating these individuals," Gov. Phil Murphy said in a statement. The patients tested negative, but the governor was clear. The state's first coronavirus cases would go to University.
That's a hospital that has struggled in recent years with a critical skill essential to battling COVID-19: controlling the spread of infection.
Less than two years ago, a deadly bacteria made its way through the facility. Three babies in the neonatal intensive care unit got infected and died. Government inspectors cited the hospital for being short of staff; failing to maintain a sanitary environment, including improper hand hygiene and sterilization; and inadequately isolating patients with respiratory conditions. They determined the hospital had put patients in "immediate jeopardy."
Today, the state's former health commissioner, Dr. Shereef Elnahal, is in charge of the hospital. He told ProPublica its infection control problems are a thing of the past. The violations cited in the report were corrected with increased screening of patients, improved handwashing and equipment and focused leadership, Elnahal said. "I'm proud of our progress since then," he said. Murphy's office directed inquiries to the state's Department of Health, where a spokeswoman said there is "complete confidence" in the hospital's ability to manage the coronavirus response.
But infection control has been a recurring problem at some of the very hospitals that would likely be called upon to treat COVID-19 patients, a ProPublica review of hundreds of hospital inspection reports found. This raises concerns that they could become hotbeds for disease, putting patients at risk and rendering infected workers unable to care for others.
"Health care workers are my top worry," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. He noted that in China, so far, about 15% of infected hospital workers have become severely ill. "If this takes place in the U.S., and we see those numbers of workers sent home or in the ICU, being taken care of by their colleagues, things will start to unravel. This is the soft underbelly of our preparedness system right now."
At least two health care workers in Northern California had preliminary positive tests for COVID-19 at NorthBay VacaValley Hospital, pending CDC confirmation. The hospital had treated a patient who later tested positive for the disease. Other health care workers who came into contact with the patient are also in quarantine.
There is no list of designated centers to handle the most critical COVID-19 patients, experts said. But the Centers for Disease Control and Prevention, during the 2014-16 Ebola outbreak, named 55 hospitals it considered to be in the first tier of treatment centers to handle that kind of crisis — mostly large, urban teaching hospitals capable of complex care like blood transfusions and ventilation.
ProPublica analyzed five years of federal hospital inspection reports for these facilities and found violations for infection control failures or other factors that could hamper the response to an outbreak at more than half of them. About 1 in 5 of the facilities had four or more violations; the analysis found more than a hundred overall. It's not clear by looking at the reports how many of the violations led to patient infections. Problems that get cited on the inspection reports are required to be corrected as part of the regulation process.
But it's also true that inspections only flag a small number of the actual problems in hospitals. American hospitals, overall, are so bad at preventing infections that hospital-acquired infections are considered a leading cause of death in the United States. The hope would be that the sites designated as specialized infection-control centers would do better.
MedStar Washington Hospital Center in Washington, D.C., says it's ready to screen coronavirus patients. Inspectors have cited the facility more than a dozen times since 2017, including for infection control failures. Among the violations: Staff did not wear and dispose of masks according to federal guidelines. Short staffing caused scores of patients to go without respiratory treatments. There were sewage leaks in operating rooms.
In an email, a spokeswoman said the hospital has addressed the failures: "We maintain a constant state of readiness for treating complex illnesses, including the coronavirus."
Montefiore Medical Center in the Bronx, New York, says on its website COVID-19 patients will be immediately isolated. But it got written up back-to-back, in 2016 and 2017, for violating infection control protocol. Among the shortcomings: "Chronic overcrowding" in its emergency room, not isolating a Hepatitis B-positive patient and contaminated supplies. Infection control breaches put patients and staff at risk, one inspection report said. Hospital officials did not respond to requests for comment.
Medical experts say they wonder: if hospitals can't control the spread of pathogens under normal conditions, what happens if they face a rush of patients with a disease as contagious and serious as the one caused by COVID-19?
During the SARS outbreak in the greater Toronto area, 44% of the total cases were among health care workers. A retrospective study, published in the journal Emerging Infectious Diseases in 2004, hypothesized that "lapses in infection control measures may be responsible," noting that caregivers were particularly at risk during procedures like intubation.
Though COVID-19, with its estimated 2% fatality rate, is far milder than SARS, which killed about 10%, it is thought to have a similar methodof transmissionand will require similar methods of protection to prevent the disease from spreading throughout hospitals. Without a proven treatment or vaccine, infected patients would need to be handled with the utmost caution. They would be isolated, and caregivers would don protective gear, including gloves, goggles, gowns and masks.
Medical providers across the country told ProPublica that they're worried about their safety and their hospitals' lack of preparation. They spoke on the condition of anonymity because they were not authorized to speak on behalf of their hospitals.
The coronavirus arrived in Washington state "like a slap in the face," a nurse in the Seattle area told ProPublica. Two weeks ago, her hospital was talking about the virus as something it was "watching, but with no big alarm." Now, the state has had the first deaths in the United States and 18 confirmed cases as of Monday. The hospital is "desperately trying to get more supplies," she said, particularly of masks and gowns. She fears that morale will drop. Already, she's heard staff grumbling that only certain units are being allocated higher-protection masks.
An acute-care nurse in Rockford, Illinois, said that just last week, a severely ill patient on her floor initially tested negative for the flu but after nearly a week retested positive. In that period, nurses were in and out of his room, and what's known as "droplet precautions" weren't always taken — for example, sometimes the patient didn't have a mask on, meaning staff members were exposed. "How easily this happened gives me serious concerns about the much more serious infection we face with COVID-19," she said.
Another nurse, at a high-level hospital in western New York that is likely to handle severely ill patients, said the only information he's received is via the hospital's internal newsletter. "Management has just said, 'We're monitoring the situation and we'll keep you updated.' It's ridiculous. They haven't verbalized a specific plan, and that increases the anxiety of a lot of the care providers." He said he and his co-workers are "resigned to the fact that we're all going to get the coronavirus."
The risk to hospital workers could have a dangerous cascading effect, said Dr. Lance Peterson, the recently retired director of clinical microbiology and infectious disease research at the NorthShore University Health System in Evanston, Illinois. He said that hospitals often keep staffing to a minimum, and that could become a problem if there's prolonged spread of the virus. "If hospital workers start getting sick," he said, "you don't want them to come to work."
Some hospitals are more prepared than others for a potential outbreak, said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. Some have spent recent weeks running drills. Officials at University Hospital in Newark and MedStar in Washington, D.C., count themselves among those.
In many ways, the United States is better prepared than many other countries for an outbreak, Peterson said. Individual patient rooms are common, which makes it easier to isolate infected patients. The SARS and Ebola outbreaks prompted many hospitals to stock up on supplies like gloves and gowns and masks, he said. And The Joint Commission, which accredits hospitals, has been monitoring their level of preparation.
But it is true there are also going to be infection control problems, he said. "Whenever you have humans in the system, there will be lapses."
The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn't trust the test's accuracy.
This article was first published on Friday, February 28, 2020 in ProPublica.
As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test.
The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn't work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.
As a result, until Wednesday the CDC and the Food and Drug Administration only allowed those state labs to use the test — a decision with potentially significant consequences. The lack of a reliable test prevented local officials from taking a crucial first step in coping with a possible outbreak — "surveillance testing" of hundreds of people in possible hotspots. Epidemiologists in other countries have used this sort of testing to track the spread of the disease before large numbers of people turn up at hospitals.
This story is based on interviews with state and local public health officials and scientists across the country, which, taken together, describe a frustrating, bewildering bureaucratic process that seemed at odds with the urgency of the growing threat. The CDC and Vice President Mike Pence's office, which is coordinating the government's response to the virus, did not respond to questions for this story. It's unclear who in the government originally made the decision to design a more complicated test, or to depart from the WHO guidance.
"We're weeks behind because we had this problem," said Scott Becker, chief executive officer of the Association of Public Health Laboratories, which represents 100 state and local public laboratories. "We're usually up-front and center and ready."
The CDC announced on Feb. 14 that surveillance testing would begin in five key cities, New York, Chicago, Los Angeles, San Francisco and Seattle. That effort has not yet begun.
On Wednesday, under pressure from health experts and public officials, the CDC and the FDA told labs they no longer had to worry about the portion of the test intended "for the universal detectionof SARS-like coronaviruses." After three weeks of struggle, they could now use the test purely to check for the presence of COVID-19.
It remains unclear whether the CDC's move on Wednesday will resolve all of the problems around the test. Some local labs have raised concerns about whether the CDC's test is fully reliable for detecting COVID-19.
In New York, scientists at both the city's and state's laboratories have seen false positives even when following the CDC's latest directions, according to a person familiar with their discussions.
"Testing for coronavirus is not available yet in New York City," city Department of Health spokeswoman Stephanie Buhle said in an email late Thursday. "The kits that were sent to us have demonstrated performance issues and cannot be relied upon to provide an accurate result."
Until the middle of this week, only the CDC and the six state labs — in Illinois, Idaho, Tennessee, California, Nevada and Nebraska — were testing patients for the virus, according to Peter Kyriacopoulos, APHL's senior director of public policy. Now, as many more state and local labs are in the process of setting up the testing kits, this capacity is expected to increase rapidly.
So far, the United States has had only 15 confirmed cases, a dozen of them travel-related, according to the CDC. An additional 45 confirmed cases involve people returning to the U.S. having gotten sick abroad. But many public health experts and officials believe that without wider testing the true number of infected Americans remains hidden.
"The basic tenet of public health is to know the situation so you can deal with it appropriately," said Marc Lipsitch, professor of epidemiology at the Harvard T. H. Chan School of Public Health. He noted that Guangdong, a province in China, conducted surveillance testing of 300,000 people in fever clinics to find about 420 positive cases. Overall, Guangdong has more than 1,000 confirmed cases. "If you don't look, you won't find cases," he said.
Janet Hamilton, senior director of Policy and Science at Council of State and Territorial Epidemiologists, said that with the virus spreading through multiple countries, "now is the time" for widespread surveillance testing.
"The disease," she said, "is moving faster than the data."
It remains to be seen what effect the delay in producing a working test will have on the health of Americans. If the United States dodges the rapidly spreading outbreaks now seen in Iran and South Korea, the impact will be negligible. But if it emerges that the disease is already circulating undetected in communities across the country, health officials will have missed a valuable chance to lessen the harm.
The need to have testing capacity distributed across local health departments became even more apparent Wednesday, when the CDC said it was investigating a case in California in which the patient may be the first infected in the United States without traveling to affected areas or known exposure to someone with the illness.
Doctors at the University of California, Davis Medical Center, where the patient is being treated, said testing was delayed for nearly a week because the patient didn't fit restrictive federal criteria, which limits tests only to symptomatic patients who recently traveled to China.
"Upon admission, our team asked public health officials if this case could be COVID-19," UC Davis said in a statement. UC Davis officials said because neither the California Department of Public Health nor Sacramento County could test for the virus, they asked the CDC to do so. But, the officials said, "since the patient did not fit the existing CDC criteria for COVID-19, a test was not immediately administered."
After this case, and under pressure from public officials, the CDC broadened its guidelines Thursday for identifying suspected patients to include people who had traveled to Iran, Italy, Japan or South Korea.
The debate over whether federal, state and local officials should have already been engaged in widespread surveillance testing has become more heated as the virus has spread globally. The CDC had said the purpose of its five-city surveillance program was to provide the U.S. with an "early warning signal" to help direct its response. The cities were selected based on the likelihood that infection would be present, Hamilton said.
But Mark Pandori, director of the Nevada State Public Health Laboratory, which began offering testing on Feb.11, said surveillance testing may not be the best use of resources right now. "A lot of people look at lab tests like they are magic," Pandori said. "But when you run lab tests, the more chances you have for getting false answers."
There are other ways to expand the country's testing capacity. Beyond the CDC and state labs, hospitals are also able to develop their own tests for diseases like COVID-19 and internally validate their effectiveness, with some oversight from the federal Centers for Medicare and Medicaid Services. But because the CDC declared the virus a public health emergency, it triggered a set of federal rules that raises the bar for all tests, including those devised by local hospitals.
So now, hospitals must validate their tests with the FDA — even if they copied the CDC protocol exactly. Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities.
Alexander Greninger, an assistant professor in laboratory medicine at the University of Washington Medical Center, said after he submitted his COVID-19 test, which copies the CDC protocol, to the FDA, a reviewer asked him to prove that his test would not show a positive result for someone infected with the SARS coronavirus or the MERS coronavirus — an almost ridiculous challenge. The SARS virus, which appeared in November 2002, affected 26 countries, disappeared in mid-2003 and hasn't been seen since. The MERS coronavirus primarily affects the Middle East, and the only two cases that have been recorded in the U.S., in 2014, were both imported.
There are labs that can create parts of a SARS virus, but the FDA's recommended supplier of such materials said it would need one to two months to provide a sample, Greninger said. He spent two days on the phone making dozens of calls, scrambling to find a lab that would provide what he needed.
Greninger said the FDA was treating labs as if they were trying to make a commercially distributed product. "I think it makes sense to have this regulation,'' he said, when "you're going to sell 100,000 widgets across the U.S. That's not who we are."
Commercial manufacturers are working to mass-produce coronavirus tests, but there isn't a precise timeline for their release. The drug company Cepheid, based in California, is targeting the second quarter of this year for the release of its test, a company spokeswoman said in an email. Massachusetts-based Hologic didn't have an estimated release date for its test, a company spokesman said. "We're responding to the public health need as rapidly as possible," the spokesman said.
Correction, Feb. 28, 2020: This story originally misstated the number of positive COVID-19 cases found via surveillance testing in the Chinese province of Guangdong. The testing found 420 positive cases, not 1,000.