Search This Blog

Monday, July 6, 2020

U.S. Is Repeating Its Deadliest Pandemic Mistake

In early April, Melvin Hector, a geriatrician in Tucson, Arizona, went into Sapphire of Tucson Nursing and Rehabilitation to check on one of his patients, who had been sent to the hospital the previous day. Hector found the woman in her room, wearing a surgical mask. She had been tested for COVID-19, but the results had not yet come back. When Hector asked for a mask for himself, he says a nurse responded, “We don’t have any.”
“I say to her, ‘You’re going into the room; the other staff are going in the room. She just went out to the hospital for a respiratory disease. And we don’t have any masks in the building?’” Hector recalled in a recent interview.
“They’re on order,” Hector remembered the nurse replying.
When Hector reported the situation to the Arizona Department of Health Services, he said Sapphire ended their working relationship. (In an email to me, Sapphire claimed that it had never suffered shortages of personal protective equipment, or PPE, and that the nurse said she didn’t know where to find more masks, not that there were none. In response to Sapphire’s statement, Hector said, “They lie.”)
To Hector, the episode was a microcosm of the myriad reasons why the United States has suffered so many COVID-19 deaths among nursing-home staff and residents. “Arizona is just one manifestation of a nationwide policy, an administrative policy to ignore this pandemic until it couldn’t be ignored,” Hector told me.
Of the country’s nearly 130,000 coronavirus deaths, more than 40 percent have been residents or employees of nursing homes and long-term care facilities. One in five facilities has reported at least one death. In just one New Jersey nursing home, at least 53 residents died after the sick were housed with the healthy and staffers had little more than rudimentary face shields for protection.
Like so many other effects of the pandemic, the U.S.’s nursing-home COVID-19 crisis is hitting communities of color especially hard. According to research by Tamara Konetzka, a health economist at the University of Chicago, nursing homes with more residents of color were more likely to have a coronavirus case or death.
And yet, state and federal officials seem to be doing little to protect the elderly from further devastation. Coronavirus cases are now surging in Sun Belt states. In recent weeks, deaths in nursing homes have continued to climb in Florida, Georgia, Texas, South Carolina, and California, according to data from the COVID Tracking Project at The Atlantic.
For now, overall deaths from COVID-19 are on a downward trajectory, potentially because COVID-19 patients are currently younger on average than those who fell ill in the Northeast this spring. However, experts say this doesn’t mean we won’t see more deaths in facilities like Sapphire of Tucson, where at least 58 residents and 36 staffers had tested positive for the coronavirus as of April, right at the time of Hector’s visit. (Arizona DHS has since inspected the facility.) Instead, the disease will likely spill from the young to the old, from bars into nursing homes.
Additional COVID-19 deaths in nursing homes are probable, and they will have been preventable. American nursing homes are chronically short-staffed and, even prior to the pandemic, were doing a poor job of controlling infections. Well into the crisis, authorities kept these facilities strapped for masks, tests, and other desperately needed equipment. And now, with the coronavirus raging across southern states, experts say the elderly will remain in danger in precisely the places so many of them typically go for a peaceful retirement. The tragedy of even more nursing-home deaths will be worsened by the fact that they could have been stopped.
Nursing-home COVID-19 deaths may seem inevitable, given that their elderly residents live cooped up together. But according to interviews with nearly a dozen nursing-home experts, it didn’t have to be this way. Worldwide, entire cities and individual nursing homes have remained coronavirus-free.
Take Hong Kong, population 7.5 million, which has reported no deaths from COVID-19 in its care homes. The city was scarred by the outbreak of severe acute respiratory syndrome, or SARS, in 2003, during which it suffered nearly 300 deaths, or almost 40 percent of the global death toll. Nursing-home residents were more likely than the general public to get SARS, and 78 percent of residents who got the virus died from it, according to Terry Lum, the head of the department of social work and social administration at the University of Hong Kong. “We also had a few doctors and nurses get killed by SARS,” Lum told me. “Those are painful to watch. We didn’t want to see that ever again.”
Immediately after the 2003 outbreak, the Hong Kong government launched a revamped policy of infectious-disease control that required nursing homes to have a designated, government-trained infection-control officer, according to Lum. All nursing homes had to maintain at least a month’s supply of face masks and other PPE.
As soon as COVID-19 broke out in Hong Kong, in January of this year, its nursing homes halted nonurgent hospital trips among residents as well as family visitation, Lum said. Nursing-home staffers donned masks as they cared for the residents. Any nursing-home residents who caught COVID-19 were isolated in hospital coronavirus wards—not in nursing homes—until they had tested negative for the virus at least twice.
There was a human cost to the lack of family visits, Lum told me; patients who had dementia deteriorated more quickly without social interaction. But nursing-home administrators were certain that if even one COVID-19 case snuck into a nursing home, it would spark a conflagration with tragic results.
Some American nursing homes have likewise succeeded at keeping out the coronavirus. The Maryland Baptist Aged Home, a 30-resident, 100-year-old facility in Baltimore, avoided having any coronavirus cases. Its director, Derrick DeWitt, told me that in February, when the U.S. had just 15 known cases, he paused family visits and community meals, sent vendors and delivery drivers to a separate entrance, and brought in extra cleaning crews. The staff was trained on social distancing, screened regularly for their temperature and symptoms, and asked about their social activities. DeWitt, following the guidance of Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, and New York Governor Andrew Cuomo, said he ordered extra masks early, before they began to run out.
Meanwhile, elsewhere in the U.S., the virtual opposite played out. Nursing homes were ill-equipped, both literally and figuratively, to deal with the pandemic, and federal and state governments took a hands-off approach until it was too late. “I think we really dropped the ball here,” David C. Grabowski, a health-care-policy professor at Harvard Medical School, told me. “We have not done right by older adults who are living in nursing homes and those that care for them.”
Nursing homes were already struggling with infection control before the pandemic hit. A Government Accountability Office report published in May found that more than 80 percent of nursing homes were cited for infection-prevention deficiencies from 2013 to 2017. About half of those homes had “persistent problems and were cited across multiple years.” The report describes, among other incidents, a New York nursing home where a respiratory infection had sickened 38 residents. The home did not isolate or maintain a list of those who were sick, and continued to let residents eat meals together.
Lum said that, like many homes in the U.S., those in Hong Kong don’t tend to have a large number of staffers for each resident. Those staffers were just very, very careful about COVID-19. But in the U.S., some experts say that staffing shortages have made nursing homes unprepared to deal with a pandemic. One recent study that examined nursing-home data in Connecticut found that long-term care facilities with lower nurse-staffing levels had higher rates of confirmed COVID-19 cases and deaths.
Grabowski and other experts have also noted that nursing-home staffers tend to make little money, so many work multiple jobs. That creates an environment in which busy, under-trained personnel are shuffling quickly between patient rooms and nursing homes, taking the virus with them.
Experts generally agree that regular testing of staff and residents in nursing homes is key to halting outbreaks. “In order to keep the virus out of a nursing home, you need to be able to test staff regularly, every time they come in for a shift,” Katie Smith Sloan, the president of LeadingAge, an advocacy group for the elderly, told me. “And you need to get results within minutes, not days.”
But this spring, asymptomatic staffers brought the virus into homes, Konetzka and other experts believe, and these workers weren’t being tested. In Rhode Island—where more than three-quarters of COVID-19 deaths have taken place in nursing homes and assisted-living facilities, according to Kaiser Family Foundation data—one home did not begin testing residents and staff until after an employee had already died of COVID-19, as ProPublica reported. In June, a House subcommittee tasked with overseeing the country’s response to the coronavirus wrote a letter to the largest American nursing-home companies, and to the Centers for Medicare and Medicaid Services, which regulates nursing homes; nationally, such facilities, the letter pointed out, still lack enough tests to meet the federal government’s recommendation that nursing homes test all residents and staff weekly. (In response to a request for comment, CMS said it was confident that all states had sufficient capacity for testing.)
And then there’s the issue of masks, which are considered another crucial element of stopping the spread of the coronavirus in nursing homes and elsewhere. Guidance on masks from CMS came much too late, Sloan said. According to a recent Reuters investigation, some nursing-home managers initially discouraged staff from wearing masks because they thought they wouldn’t help prevent infections.
Unlike those in Hong Kong, American nursing homes didn’t have months of masks stocked up. When the virus hit, they were tearing through their supplies at hundreds of times the rate they normally would. Hospitals, not nursing homes, were seen as the priority destination for the country’s precious reserves of masks. “We somehow expect individual nursing-home operators to compete against large hospitals and states in trying to get that equipment,” Konetzka said.
FEMA said it would ship supplies to nursing homes in May. But as Kaiser Health News reported, some homes received cloth masks instead of surgical ones or N95s, which are considered the gold standard for treating COVID-19 patients. (“FEMA did not ship N95 respirators or cotton masks as part of the nursing-home deliveries,” an agency spokesperson told me. “[The Health and Human Services Department] is providing cloth facial coverings as part of a separate, multipronged approach.”) Perhaps expectedly, months into the pandemic, many nursing homes ran out of masks and gowns. In early June, federal data showed that more than 250 nursing homes had no surgical masks and 800 more were a week away from running out.
To make matters worse, nursing homes across the U.S. took in COVID-19 patients from hospitals. In Minnesota, 77 percent of COVID-19 deaths have taken place in nursing homes, according to the Kaiser Family Foundation. Despite this, Minnesota hospitals discharged dozens of COVID-19 patients to nursing homes, the Minneapolis Star Tribune reported in May. “Hospitals were running out of space,” Sloan said. “And so they were transferring people to nursing homes. And our nursing homes were saying, ‘You can’t give us people who have COVID unless you give us PPE.’”
Adding to the challenge is that it’s not clear whose problem the nursing-home shortcomings are. Considering CMS is tasked with nursing-home safety, if the agency doesn’t “have enough resources, they should be going to Congress and demanding those resources,” Andy Slavitt, the former acting administrator of CMS under President Barack Obama, told me.
In response to a request for comment, CMS said that although the agency does oversee facilities, nursing homes are themselves responsible for the health of residents and should work with state governments to procure PPE.
But nursing homes received different levels of help and guidance from states and localities. Some states helped nursing homes test all of their staff, for example, while others didn’t, Maggie Flynn, a reporter at Skilled Nursing News, told me. Only certain states have increased pandemic-relief funding to nursing homes, according to LeadingAge.
All told, this lack of government coordination has led to poor and delayed data collection on deaths and infections in nursing homes. CMS did not require facilities to report coronavirus infections and deaths that occurred prior to May 8, even though the first nursing-home outbreak began in February. When CMS did begin compiling nursing-home infection and death data, it was found to be riddled with errors. (In its response to me, CMS said it would be refining the data over time.)
Given the dearth of accurate federal data, the Kaiser Family Foundation and the COVID Tracking Project have been independently compiling lists of coronavirus infections and deaths in nursing homes and other long-term care facilities by state. Yet even there, gaps remain because not all states have been publicly reporting their nursing-home infection data.
As with so many other elements of the pandemic, the federal government and states could have learned from their previous failures on nursing homes. As COVID-19 ravaged care facilities along the East Coast all spring, officials in southern states, where infections are currently spiking, had months to prepare. Still, we’ll very likely see even more nursing-home deaths in the Sun Belt. “I’m very concerned that the explosion of cases in Florida, Texas, Arizona, and California will lead to a dramatic increase in cases in nursing homes,” the former Kansas Governor Mark Parkinson, now the head of the American Health Care Association, a nursing-home trade group, told me.
Reports from multiple states, including those presently experiencing large coronavirus outbreaks, paint a bleak picture of nursing-home readiness for a COVID-19 surge. Some facilities in Texas still don’t have the masks and the testing capacity they need, according to Patty Ducayet, the long-term care ombudsman for Texas. Dana Marie Kennedy, the state director of AARP Arizona, told me that while the state’s skilled-nursing facilities have received federal money for PPE, assisted-living facilities, which aren’t regulated by CMS, are struggling to get supplies. In fact, much of the money allocated for nursing homes in the coronavirus relief bill hasn’t been distributed yet, according to a letter sent by two members of Congress in June. And Parkinson said even that amount—$200 million—pales in comparison with what nursing homes actually need.
The humble mask, which officials have known to be an essential virus-fighting tool for months now, is still in short supply. According to a recent National Nurses United poll, 85 percent of nurses were still being asked to reuse PPE as of last month. Melinda Haschak, a licensed practical nurse in Connecticut, testified before the House Ways and Means Committee in late June that workers at her home still lack protective equipment. Parkinson told me that “the PPE shortage is still not over,” especially when it comes to N95 masks. That means many nursing homes are still on what’s called a “conservation protocol,” reusing gowns and masks—and potentially infecting themselves in the process. In Arizona, Melvin Hector told me of another home he worked in, which he declined to name, where he claims nurses were going between the rooms of different patients—some of whom had COVID-19—wearing the same gown, simply because there weren’t enough to go around.
Arizona, Florida, and Texas are now considered the epicenters of the pandemic. According to the latest CMS data (which, again, has had some reliability issues), out of 10,322 nursing homes in those states, 1,166, or about 11 percent, currently don’t have a one-week supply of N95 masks. Texas nursing homes are still reporting defective shipments of PPE from the federal government.
The same goes for tests. After the White House Coronavirus Task Force in May urged states to test all residents and staff of elder-care facilities, Florida Governor Ron DeSantis said the state would not be doing so, the Tampa Bay Times reported. In Arizona, Kennedy said, “testing is totally inadequate.” Parkinson pointed out that beyond simply mandating the tests, states need to pay for them, because many homes can’t afford to. Meanwhile, Konetzka said that truly stopping outbreaks in nursing homes requires “testing at the right time with rapid results, such that people can be separated in time before the virus spreads through the facility.” And that requires even more staff to perform the tests.
Still, one of the strongest correlates of whether nursing homes experience outbreaks is whether the surrounding community has lots of COVID-19 cases—which is certainly the circumstance right now in the Sun Belt. Nursing-home staffers leave work, after all, and go to the grocery store, where they might brush up against someone who’s positive. When they return to work, the virus creeps in with them. “There’s a good chance that they’re going to come in contact with somebody, and that’s the most likely way that COVID-19 is going to get into a building in the first place,” Greg Shelley, the manager of the Harris County Long-Term Care Ombudsman Program at the Cizik School of Nursing at the University of Texas, told me. Already, the Arizona Republic reported in late June that a large senior community in Phoenix had an outbreak of the coronavirus, with 16 staffers and two residents testing positive.
Some experts say the best way to stop coronavirus outbreaks inside nursing homes, then, is to stop them outside of nursing homes first. But state and federal leaders have largely failed to do that too. In April, Texas Governor Greg Abbott prohibited local officials from issuing mandatory mask orders. Texas saw its highest number of daily deaths the day before Abbott decided to reopen stores, restaurants, and movie theaters at 25 percent capacity. In Florida and Arizona, too, governors have resisted statewide mask mandates. (The Arizona and Texas governors have since reversed course.)
That’s to say nothing of leadership higher up. Vice President Mike Pence held a large indoor rally, complete with maskless singing, at a church in Dallas last week as Texas hospitals filled to capacity. And aside from tweeting misleading statements about it, President Donald Trump has scaled back his engagement on the coronavirus.
Nursing homes are on their own when it comes to combatting the coronavirus, in other words. But then again, so is everyone else.

China’s SinoVac starts late stage trials for its COVID-19 vaccine

China’s SinoVac is starting Phase III trials of its potential coronavirus vaccine, it said on Monday, becoming one of three companies to move into the late stages in the race to develop an inoculation against the disease.
It will start recruiting volunteers this month, it said in a release published on China’s WeChat messaging app platform. Last week, Brazil gave the go-ahead for the company to start testing volunteers in the country.
The World Health Organization’s (WHO) latest document released on Monday outlining the status of trials being conducted around the globe said SinoVac’s was now at Phase III. https://bit.ly/2O1DiH7
AstraZeneca’s experimental COVID-19 vaccine, which was developed by researchers at the University of Oxford, and Sinopharm are the only other candidates in late-stage Phase III trials.
SinoVac is building a vaccine plant, which it hopes will be ready this year and capable of making up to 100 million shots a year.
Phase I and Phase II trials typically test the safety of a drug before it enters Phase III trials that test its efficacy.
There are 19 vaccine trials in clinical evaluation and hundreds being developed and tested around the world to stop the COVID-19 pandemic, which has killed hundreds of thousands and ravaged the global economy.
No COVID-19 vaccine has yet been approved for commercial use. A Massachusetts Institute of Technology analysis last year found that about one in three vaccines in the first stage of testing later gains approval.

Pandemic drives boom in germ-busting spray machines

Timothy Kane, CEO of Goodway Technologies Corp, has never been so popular. Making machines that spray disinfectant, once a niche business, is now an essential service – and the phone is ringing off the hook.
“Our orders jumped 50-fold in April, it was like a switch got flipped,” said Kane.
Goodway, which has a factory in Stamford, Connecticut, builds machines that spray an alcohol-infused mist to sanitize surfaces. Until a few months ago, those devices were just a tiny part of its business, catering mostly to places like industrial bakeries that had to constantly clean surfaces.
Now, as the COVID-19 pandemic grips the United States, everyone wants one.
Kane, who employs 110 workers in the family-owned company, has fielded calls from hotels, gyms and casinos, as well as factories and warehouses. Many would previously never have thought they needed such machines, which often look much like souped-up vacuum cleaners.
The rise of this industry is one example of a sector that is booming during a pandemic that has laid waste to so many parts of the economy.
America’s battle against the novel coronavirus is driving demand for everything from hand sanitizer and masks to thermometer guns and plexiglass. But one enduring image of this crisis may be the foggers and spraying machines that are now being set loose in airports, sports arenas and subways.
Yvon Brunache bought a Goodway sprayer to help his Florida construction business because clients fearing COVID-19 were reluctant to have his team in their buildings. “My customers are asking more and more for the space to be sanitized,” he said.
The surge of business is, however, putting strain on producers that never envisaged such a situation and their supply chains.
Victory Innovations, another maker of hi-tech spray machines, is sold out through September. Its shipments have surged 10-fold since the start of the pandemic, to about 100,000 units a month, according to the company, based in Eden Prairie, Minnesota.
ROBOT FLEET
Servpro Industries LLC has completed 10,000 coronavirus-related deep cleaning operations in the last 90 days, according to Chief Operating Officer John Sooker.
“We’ve always done biohazard cleaning, but never at this scale.”
Servpro, based in Gallatin, Tennessee, is majority owned by the Blackstone Group and runs franchised cleaning businesses across the United States and Canada.
The company, which had sales of about $3 billion last year, figures biohazard cleaning – such as sanitizing a cruise ship after an outbreak of illness – constituted only about 5% of its business then, or $150 million.
Sooker said he expects COVID-19-related cleaning alone to bring in at least $250 million to $300 million this year.
The crisis is sparking innovation.
Albuquerque’s airport has just introduced a fleet of four robots, each about the size of a small trash can on wheels, which trundle around the terminals every night spraying a disinfectant mist.
“It costs a fraction of what it would cost to have a team of people doing it,” said Kimberly Corbitt, chief commercial officer of Build With Robots, one of the machines’ developers, although she declined to reveal the cost.
The airport emphasized that none of its janitors would get laid off as a result, since the fogging is an added layer of overnight cleaning.
FLAMETHROWER
Sophisticated spraying machines don’t come cheap, though, even the less automated ones; a small human-operated sprayer mounted in a backpack can set you back about $5,000.
Biomist Inc., a manufacturer in Wheeling, Ill., has installed spraying systems custom-designed for a facility that cost over $50,000, said Robert Cook, a vice president.
Goodway, meanwhile, has doubled the number of models it is selling to six, creating designs tailored to specific uses such as restaurants and health clubs.
Workers at its factory can be seen hunched over a row of curved stainless-steel machines mounted on wheels being built on the production floor.
CEO Kane said there were many ways to spray disinfectants, and that the process could be surprisingly complex, and even potentially dangerous.
Some machines use water-based cleansers, which take time to dry or must be followed by people wiping the surfaces. Other devices, like those made by Goodway, mix alcohol – which dries almost instantly – with the same chemicals used in fire extinguishers, Kane said.
“If you don’t do it right, you can end up with a flamethrower.”

Anixa and OntoChem identify potential COVID-19 candidates

Anixa Biosciences (ANIX -6.3%) along with its partner, OntoChem has completed the initial in silico screening process of their drug discovery program and identified an additional specific compound, as potential inhibitor of the main protease (Mpro) of the virus.
Based on initial identification of the Mpro scaffold compound, the companies have created a new in silico library of analog compounds to be evaluated through additional in silico screening to choose which additional compounds may be synthesized and evaluated in biological assays.
As previously announced, Anixa and OntoChem have identified four compounds that could disrupt the function of a viral enzyme called an endoribonuclease.


Emergent Bio inks five-year deal with J&J for manufacture of COVID-19 vaccine

Emergent BioSolutions (NYSE:EBS) has closed a five-year agreement with Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for large-scale drug substance manufacturing for J&J’s SARS-CoV-2 vaccine, Ad26.COV2-S.
EBS will provide contract development and manufacturing services over the contract term valued at ~$480M for the first two years. Volume manufacturing will start in 2021 at its Baltimore Bayview facility subsequent to technology transfer.
The company will release updated 2020 guidance when it reports Q2 results.