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The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed. The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed.
(7 days later)
Thirteen years ago, a group of U.S. public health officials came up with a plan to address what they regarded as one of the medical system’s crucial vulnerabilities: a shortage of ventilators.Thirteen years ago, a group of U.S. public health officials came up with a plan to address what they regarded as one of the medical system’s crucial vulnerabilities: a shortage of ventilators.
The breathing-assistance machines tended to be bulky, expensive and limited in number. The plan was to build a large fleet of inexpensive portable devices to deploy in a flu pandemic or another crisis.The breathing-assistance machines tended to be bulky, expensive and limited in number. The plan was to build a large fleet of inexpensive portable devices to deploy in a flu pandemic or another crisis.
Money was budgeted. A federal contract was signed. Work got underway.Money was budgeted. A federal contract was signed. Work got underway.
And then things suddenly veered off course. A multibillion-dollar maker of medical devices bought the small California company that had been hired to design the new machines. The project ultimately produced zero ventilators.And then things suddenly veered off course. A multibillion-dollar maker of medical devices bought the small California company that had been hired to design the new machines. The project ultimately produced zero ventilators.
That failure delayed the development of an affordable ventilator by at least half a decade, depriving hospitals, states and the federal government of the ability to stock up. The federal government started over with another company in 2014, whose ventilator was approved only last year and whose products have not yet been delivered.That failure delayed the development of an affordable ventilator by at least half a decade, depriving hospitals, states and the federal government of the ability to stock up. The federal government started over with another company in 2014, whose ventilator was approved only last year and whose products have not yet been delivered.
Today, with the coronavirus ravaging America’s health care system, the nation’s emergency-response stockpile is still waiting on its first shipment. The scarcity of ventilators has become an emergency, forcing doctors to make life-or-death decisions about who gets to breathe and who does not.Today, with the coronavirus ravaging America’s health care system, the nation’s emergency-response stockpile is still waiting on its first shipment. The scarcity of ventilators has become an emergency, forcing doctors to make life-or-death decisions about who gets to breathe and who does not.
The stalled efforts to create a new class of cheap, easy-to-use ventilators highlight the perils of outsourcing projects with critical public-health implications to private companies; their focus on maximizing profits is not always consistent with the government’s goal of preparing for a future crisis.The stalled efforts to create a new class of cheap, easy-to-use ventilators highlight the perils of outsourcing projects with critical public-health implications to private companies; their focus on maximizing profits is not always consistent with the government’s goal of preparing for a future crisis.
“We definitely saw the problem,” said Dr. Thomas R. Frieden, who ran the Centers for Disease Control and Prevention from 2009 to 2017. “We innovated to try and get a solution. We made really good progress, but it doesn’t appear to have resulted in the volume that we needed.”“We definitely saw the problem,” said Dr. Thomas R. Frieden, who ran the Centers for Disease Control and Prevention from 2009 to 2017. “We innovated to try and get a solution. We made really good progress, but it doesn’t appear to have resulted in the volume that we needed.”
The project — code-named Aura — came in the wake of a parade of near-miss pandemics: SARS, MERS, bird flu and swine flu.The project — code-named Aura — came in the wake of a parade of near-miss pandemics: SARS, MERS, bird flu and swine flu.
Federal officials decided to re-evaluate their strategy for the next public health emergency. They considered vaccines, antiviral drugs, protective gear and ventilators, the last line of defense for patients suffering respiratory failure. The federal government’s Strategic National Stockpile had full-service ventilators in its warehouses, but not in the quantities that would be needed to combat a major pandemic.Federal officials decided to re-evaluate their strategy for the next public health emergency. They considered vaccines, antiviral drugs, protective gear and ventilators, the last line of defense for patients suffering respiratory failure. The federal government’s Strategic National Stockpile had full-service ventilators in its warehouses, but not in the quantities that would be needed to combat a major pandemic.
In 2006, the Department of Health and Human Services established a new division, the Biomedical Advanced Research and Development Authority, with a mandate to prepare medical responses to chemical, biological and nuclear attacks, as well as infectious diseases.In 2006, the Department of Health and Human Services established a new division, the Biomedical Advanced Research and Development Authority, with a mandate to prepare medical responses to chemical, biological and nuclear attacks, as well as infectious diseases.
In its first year in operation, the research agency considered how to expand the number of ventilators. It estimated that an additional 70,000 machines would be required in a moderate influenza pandemic.In its first year in operation, the research agency considered how to expand the number of ventilators. It estimated that an additional 70,000 machines would be required in a moderate influenza pandemic.
The ventilators in the national stockpile were not ideal. In addition to being big and expensive, they required a lot of training to use. The research agency convened a panel of experts in November 2007 to devise a set of requirements for a new generation of mobile, easy-to-use ventilators.The ventilators in the national stockpile were not ideal. In addition to being big and expensive, they required a lot of training to use. The research agency convened a panel of experts in November 2007 to devise a set of requirements for a new generation of mobile, easy-to-use ventilators.
In 2008, the government requested proposals from companies that were interested in designing and building the ventilators.In 2008, the government requested proposals from companies that were interested in designing and building the ventilators.
The goal was for the machines to be approved by regulators for mass development by 2010 or 2011, according to budget documents that the Department of Health and Human Services submitted to Congress in 2008. After that, the government would buy as many as 40,000 new ventilators and add them to the national stockpile.The goal was for the machines to be approved by regulators for mass development by 2010 or 2011, according to budget documents that the Department of Health and Human Services submitted to Congress in 2008. After that, the government would buy as many as 40,000 new ventilators and add them to the national stockpile.
The ventilators were to cost less than $3,000 each. The lower the price, the more machines the government would be able to buy.The ventilators were to cost less than $3,000 each. The lower the price, the more machines the government would be able to buy.
Companies submitted bids for the Project Aura job. The research agency opted not to go with a large, established device maker. Instead it chose Newport Medical Instruments, a small outfit in Costa Mesa, Calif.Companies submitted bids for the Project Aura job. The research agency opted not to go with a large, established device maker. Instead it chose Newport Medical Instruments, a small outfit in Costa Mesa, Calif.
Newport, which was owned by a Japanese medical device company, only made ventilators. Being a small, nimble company, Newport executives said, would help it efficiently fulfill the government’s needs.Newport, which was owned by a Japanese medical device company, only made ventilators. Being a small, nimble company, Newport executives said, would help it efficiently fulfill the government’s needs.
Ventilators at the time typically went for about $10,000 each, and getting the price down to $3,000 would be tough. But Newport’s executives bet they would be able to make up for any losses by selling the ventilators around the world.Ventilators at the time typically went for about $10,000 each, and getting the price down to $3,000 would be tough. But Newport’s executives bet they would be able to make up for any losses by selling the ventilators around the world.
“It would be very prestigious to be recognized as a supplier to the federal government,” said Richard Crawford, who was Newport’s head of research and development at the time. “We thought the international market would be strong, and there is where Newport would have a good profit on the product.”“It would be very prestigious to be recognized as a supplier to the federal government,” said Richard Crawford, who was Newport’s head of research and development at the time. “We thought the international market would be strong, and there is where Newport would have a good profit on the product.”
Federal officials were pleased. In addition to replenishing the national stockpile, “we also thought they’d be so attractive that the commercial market would want to buy them, too,” said Nicole Lurie, who was then the assistant secretary for preparedness and response inside the Department of Health and Human Services. With luck, the new generation of ventilators would become ubiquitous, helping hospitals nationwide better prepare for a crisis.Federal officials were pleased. In addition to replenishing the national stockpile, “we also thought they’d be so attractive that the commercial market would want to buy them, too,” said Nicole Lurie, who was then the assistant secretary for preparedness and response inside the Department of Health and Human Services. With luck, the new generation of ventilators would become ubiquitous, helping hospitals nationwide better prepare for a crisis.
The contract was officially awarded a few months after the H1N1 outbreak, which the C.D.C. estimated infected 60 million and killed 12,000 in the United States, began to taper off in 2010. The contract called for Newport to receive $6.1 million upfront, with the expectation that the government would pay millions more as it bought thousands of machines to fortify the stockpile.The contract was officially awarded a few months after the H1N1 outbreak, which the C.D.C. estimated infected 60 million and killed 12,000 in the United States, began to taper off in 2010. The contract called for Newport to receive $6.1 million upfront, with the expectation that the government would pay millions more as it bought thousands of machines to fortify the stockpile.
Project Aura was Newport’s first job for the federal government. Things moved quickly and smoothly, employees and federal officials said in interviews.Project Aura was Newport’s first job for the federal government. Things moved quickly and smoothly, employees and federal officials said in interviews.
Every three months, officials with the biomedical research agency would visit Newport’s headquarters. Mr. Crawford submitted monthly reports detailing the company’s spending and progress.Every three months, officials with the biomedical research agency would visit Newport’s headquarters. Mr. Crawford submitted monthly reports detailing the company’s spending and progress.
The federal officials “would check everything,” he said. “If we said we were buying equipment, they would want to know what it was used for. There were scheduled visits, scheduled requirements and deliverables each month.”The federal officials “would check everything,” he said. “If we said we were buying equipment, they would want to know what it was used for. There were scheduled visits, scheduled requirements and deliverables each month.”
In 2011, Newport shipped three working prototypes from the company’s California plant to Washington for federal officials to review.In 2011, Newport shipped three working prototypes from the company’s California plant to Washington for federal officials to review.
Dr. Frieden, who ran the C.D.C. at the time, got a demonstration in a small conference room attached to his office. “I got all excited,” he said. “It was a multiyear effort that had resulted in something that was going to be really useful.”Dr. Frieden, who ran the C.D.C. at the time, got a demonstration in a small conference room attached to his office. “I got all excited,” he said. “It was a multiyear effort that had resulted in something that was going to be really useful.”
In April 2012, a senior Health and Human Services official testified before Congress that the program was “on schedule to file for market approval in September 2013.” After that, the machines would go into production.In April 2012, a senior Health and Human Services official testified before Congress that the program was “on schedule to file for market approval in September 2013.” After that, the machines would go into production.
Updated July 7, 2020
The coronavirus can stay aloft for hours in tiny droplets in stagnant air, infecting people as they inhale, mounting scientific evidence suggests. This risk is highest in crowded indoor spaces with poor ventilation, and may help explain super-spreading events reported in meatpacking plants, churches and restaurants. It’s unclear how often the virus is spread via these tiny droplets, or aerosols, compared with larger droplets that are expelled when a sick person coughs or sneezes, or transmitted through contact with contaminated surfaces, said Linsey Marr, an aerosol expert at Virginia Tech. Aerosols are released even when a person without symptoms exhales, talks or sings, according to Dr. Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
Then everything changed.Then everything changed.
The medical device industry was undergoing rapid consolidation, with one company after another merging with or acquiring other makers. Manufacturers wanted to pitch themselves as one-stop shops for hospitals, which were getting bigger, and that meant offering a broader suite of products. In May 2012, Covidien, a large medical device manufacturer, agreed to buy Newport for just over $100 million.The medical device industry was undergoing rapid consolidation, with one company after another merging with or acquiring other makers. Manufacturers wanted to pitch themselves as one-stop shops for hospitals, which were getting bigger, and that meant offering a broader suite of products. In May 2012, Covidien, a large medical device manufacturer, agreed to buy Newport for just over $100 million.
Covidien — a publicly traded company with sales of $12 billion that year — already sold traditional ventilators, but that was only a small part of its multifaceted businesses. In 2012 alone, Covidien bought five other medical device companies, in addition to Newport.Covidien — a publicly traded company with sales of $12 billion that year — already sold traditional ventilators, but that was only a small part of its multifaceted businesses. In 2012 alone, Covidien bought five other medical device companies, in addition to Newport.
Newport executives and government officials working on the ventilator contract said they immediately noticed a change when Covidien took over. Developing inexpensive portable ventilators no longer seemed like a top priority.Newport executives and government officials working on the ventilator contract said they immediately noticed a change when Covidien took over. Developing inexpensive portable ventilators no longer seemed like a top priority.
Newport applied in June 2012 for clearance from the Food and Drug Administration to market the device, but two former federal officials said Covidien had demanded additional funding and a higher sales price for the ventilators. The government gave the company an additional $1.4 million, a drop in the bucket for a company Covidien’s size.Newport applied in June 2012 for clearance from the Food and Drug Administration to market the device, but two former federal officials said Covidien had demanded additional funding and a higher sales price for the ventilators. The government gave the company an additional $1.4 million, a drop in the bucket for a company Covidien’s size.
Government officials and executives at rival ventilator companies said they suspected that Covidien had acquired Newport to prevent it from building a cheaper product that would undermine Covidien’s profits from its existing ventilator business.Government officials and executives at rival ventilator companies said they suspected that Covidien had acquired Newport to prevent it from building a cheaper product that would undermine Covidien’s profits from its existing ventilator business.
Some Newport executives who worked on the project were reassigned to other roles. Others decided to leave the company.Some Newport executives who worked on the project were reassigned to other roles. Others decided to leave the company.
“Up until the time the company sold, I was really happy and excited about the project,” said Hong-Lin Du, Newport’s president at the time of its sale. “Then I was assigned to a different job.”“Up until the time the company sold, I was really happy and excited about the project,” said Hong-Lin Du, Newport’s president at the time of its sale. “Then I was assigned to a different job.”
In 2014, with no ventilators having been delivered to the government, Covidien executives told officials at the biomedical research agency that they wanted to get out of the contract, according to three former federal officials. The executives complained that it was not sufficiently profitable for the company.In 2014, with no ventilators having been delivered to the government, Covidien executives told officials at the biomedical research agency that they wanted to get out of the contract, according to three former federal officials. The executives complained that it was not sufficiently profitable for the company.
The government agreed to cancel the contract. The world was focused at the time on the Ebola outbreak in West Africa. The research agency started over, awarding a new contract for $13.8 million to the giant Dutch company Philips. In 2015, Covidien was sold for $50 billion to another huge medical device company, Medtronic. Charles J. Dockendorff, Covidien’s former chief financial officer, said he did not know why the contract had fallen apart. “I am not aware of that issue,” he said in a text message.The government agreed to cancel the contract. The world was focused at the time on the Ebola outbreak in West Africa. The research agency started over, awarding a new contract for $13.8 million to the giant Dutch company Philips. In 2015, Covidien was sold for $50 billion to another huge medical device company, Medtronic. Charles J. Dockendorff, Covidien’s former chief financial officer, said he did not know why the contract had fallen apart. “I am not aware of that issue,” he said in a text message.
Robert J. White, president of the minimally invasive therapies group at Medtronic who worked at Covidien during the Newport acquisition, initially said he had no recollection of the Project Aura contract. A Medtronic spokeswoman later said that Mr. White was under the impression that the contract had been winding down before Covidien bought Newport.Robert J. White, president of the minimally invasive therapies group at Medtronic who worked at Covidien during the Newport acquisition, initially said he had no recollection of the Project Aura contract. A Medtronic spokeswoman later said that Mr. White was under the impression that the contract had been winding down before Covidien bought Newport.
In a statement Sunday night, after the article was published, Medtronic said, “The prototype ventilator, developed by Newport Medical, would not have been able to meet the specifications required by the government, nor at the price required.” Medtronic said that one problem was that the machine was not going to be usable with newborns.In a statement Sunday night, after the article was published, Medtronic said, “The prototype ventilator, developed by Newport Medical, would not have been able to meet the specifications required by the government, nor at the price required.” Medtronic said that one problem was that the machine was not going to be usable with newborns.
It wasn’t until last July that the F.D.A. signed off on the new Philips ventilator, the Trilogy Evo. The government ordered 10,000 units in December, setting a delivery date in mid-2020.It wasn’t until last July that the F.D.A. signed off on the new Philips ventilator, the Trilogy Evo. The government ordered 10,000 units in December, setting a delivery date in mid-2020.
As the extent of the spread of the new coronavirus in the United States became clear, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, revealed on March 15 that the stockpile had 12,700 ventilators ready to deploy. The government has since sped up maintenance to increase the number available to 16,660 — still fewer than a quarter of what officials years earlier had estimated would be required in a moderate flu pandemic.As the extent of the spread of the new coronavirus in the United States became clear, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, revealed on March 15 that the stockpile had 12,700 ventilators ready to deploy. The government has since sped up maintenance to increase the number available to 16,660 — still fewer than a quarter of what officials years earlier had estimated would be required in a moderate flu pandemic.
Last week, the Health and Human Services Department contacted ventilator makers to see how soon they could produce thousands of machines. And it began pressing Philips to speed up its planned shipments.Last week, the Health and Human Services Department contacted ventilator makers to see how soon they could produce thousands of machines. And it began pressing Philips to speed up its planned shipments.
The stockpile is “still awaiting delivery of the Trilogy Evo,” a Health and Human Services spokeswoman said. “We do not currently have any in inventory, though we are expecting them soon.”The stockpile is “still awaiting delivery of the Trilogy Evo,” a Health and Human Services spokeswoman said. “We do not currently have any in inventory, though we are expecting them soon.”
Kitty Bennett contributed research.Kitty Bennett contributed research.