More hospitals poised to require COVID-19 vaccines

It’s “a trickle that will become a torrent,” Ashish Jha, dean at Brown University’s School of Public Health, tweeted.

More hospitals are likely to require employees receive a COVID-19 vaccine, experts said, to further protect the sick and vulnerable patients who rely on them for care.

A Houston-area hospital captured headlines after taking a firm stance on requiring vaccines that prevent severe illness of the coronavirus, which has killed more than 600,000 in the U.S. and ravaged the economy.

Houston Methodist employees who refused the vaccine were either terminated or resigned. A judge earlier this month sided with the hospital and tossed out an employee lawsuit that was seeking to block the mandated inoculation. The ruling may give other hospitals the green light to require the jab, and as more facilities put a similar policy in place, others are likely to follow, experts said.

It’s “a trickle that will become a torrent,” Ashish Jha, professor and dean at Brown University’s School of Public Health, posted Thursday on Twitter.

3 large health systems in Massachusetts to require all workers to be vaccinated.

Given the critical need to protect vulnerable patients, its critical all hospitals do this.

Leading systems will do it soon.

Laggards will get there eventually.

Joining the growing tide of vaccine mandates are a variety of systems and hospitals, including Mass General Brigham in Boston, BJC Healthcare in St. Louis and Inova Health System in Virginia.

Some of the nation’s largest health systems have yet to mandate the shot, including Kaiser Permanente and CommonSpirit Health.

“Vaccination will only be required for Kaiser Permanente employees if a state or county where we operate mandates the vaccine for health care workers,” the company said in an email.

The American Hospital Association continues to hear that a growing number of its members are requiring the vaccine, with some exemptions. However, many member hospitals are waiting until the FDA grants full approval, a time when more safety and efficacy data will be made available.

“Getting vaccinated is especially critical for health care professionals because they work with patients with underlying health conditions whose immune systems may be compromised,” AHA, which has not taken on stance on the requirement, said in a statement.

The mandates raise ethical questions, some say, pointing to the profession’s promise to “do no harm.”

Arthur Caplan, head of medical ethics at New York University School of Medicine, said the codes of ethics that doctors and nurses says to put patients first, do no harm and protect the vulnerable.

“Of course they should be vaccinated,” he said. “If they don’t want to get vaccinated, I think they’re in the wrong profession.”

The Equal Employment Opportunity Commission said employment law does not prohibit employers from requiring the jab, essentially giving the green light to employers to put incentives and requirements in place for their workers. The EEOC is the federal agency tasked with ensuring that workplaces do not discriminate.

Some states are going against the tide and signing legislation that bars vaccine mandates, including Florida. The city of San Francisco will require hospital employees and workers in high-risk settings to get the vaccine. San Francisco, like other employers and universities, will require all city workers get inoculated.

The differing policy stances across the country creates additional hurdles for corporations with a large footprint.

Los Angeles hospitals brace for care rationing

Rising Covid cases means Americans may face health care rationing. Here's  how they view that.

Several hospitals in Los Angeles County are preparing for the possibility of restrategizing care delivery in the coming weeks amid growing COVID-19 hospitalizations, according to the Los Angeles Times.

Los Angeles County reported 6,018 COVID-19 hospitalizations Dec. 20 — a 2.5 percent increase from the day prior — with 1,198 patients in ICUs, according to the state’s data dashboard. Statewide, 17,750 patients are hospitalized with COVID-19, 3,710 of them in ICUs. 

The LA Times obtained a document recently circulated among physicians at the four county-run hospitals that outlines resource allocation in crisis situations. The guidelines call for physicians to save as many patients as possible versus trying everything to save a patient, meaning those less likely to survive will not receive the level of care they would have otherwise. L.A. County Health Services Director Christina Ghaly, MD, told the LA Times that the guidelines were not in place as of Friday night.

California activated its “mass fatality” program last week, which coordinates mutual aid across several government agencies when more deaths take place in a period of time than can be handled by local coroner or medical emergency personnel, NPR reports. 

Nearly all of the state is under stay-at-home orders, with residents prohibited from gathering with anyone outside their immediate household.

“I have yet to see any clear signals that things are slowing down, and I’m very concerned about the next two months,” Timothy Brewer, MD, an epidemiologist with UCLA Health, told the LA Times. He said UCLA Health is scheduling several infectious disease specialists to be on call at any time, and the biggest issue is that hospitals may quickly run out of providers who can administer ICU-level care.

Oregon suspends license of physician who discouraged mask-wearing

Oregon suspends license of physician who discouraged mask-wearing

An Oregon physician who publicly spoke out against wearing a mask to slow the spread of COVID-19 has had his medical license suspended, according to The Washington Post.

In a written order Dec. 4, the Oregon Medical Board suspended the license of Steven A. LaTulippe, MD, a family medicine physician at South View Medical Arts in Dallas, Ore. The board alleges Dr. LaTulippe engaged in “conduct that is contrary to medical ethics and does or might constitute a danger to the health or safety of the public.” 

It also accuses him of “gross negligence.”

Specific acts cited in the letter include the physician’s alleged advice to a Medicaid patient. According to the board, the patient contacted Dr. LaTulippe’s medical clinic in July for guidance on COVID-19 and was told asymptomatic people should not be tested, that wearing masks does not prevent virus transmission, and the patient was told not to self-isolate because exposure to others would provide COVID-19 immunity.

The board said the patient seeking the guidance from Dr. LaTulippe’s clinic was terminated as a patient after questioning the appropriateness of the guidance.

The board also contends workers in Dr. LaTulippe’s clinic refuse to wear masks at work and urge people who enter the clinic wearing masks to remove them.

Dr. LaTulippe “regularly tells his patients that masks are ineffective in preventing the spread of COVID-19 and should not be worn”; “directs patients to a YouTube video providing false information about mask-wearing” ; and “regularly advises, particularly for his elderly and pediatric patients, that it is ‘very dangerous’ to wear masks because masks exacerbate [chronic obstructive pulmonary disease] and asthma and cause or contribute to multiple serious health conditions,” according to the board.

The Post could not immediately reach Dr. LaTulippe for comment Dec. 5.

In a recent interview, Dr. LaTulippe told NBC News he believes there is “bad science behind” wearing masks.

“I have absolutely zero problems with infectivity, and I have completely successful treatments, so I ask, ‘What is the problem?’ Why would I be demonized if I know what I’m doing?” he told the news network.

The CDC has advocated wearing masks to combat COVID-19. 

Experts Slam The White House’s ‘Herd Immunity’ Plan

Experts warn Trump's misinformation about coronavirus is dangerous

The White House is reportedly embracing a herd-immunity approach focused on “protecting the elderly and the vulnerable” but experts are calling the plan dangerous, “unethical”, and equivalent to “mass murder”.

The news comes following a petition titled The Great Barrington Declaration, which argued against lockdowns and school and business closures and got almost 500,000 signatures – although some of them were fake.

“Current lockdown policies are producing devastating effects on short and long-term public health,” the declaration states, adding, “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk. We call this Focused Protection.”

Essentially, herd immunity is when enough people are immune to a disease, like Covid-19, that the disease can’t be transmitted as easily and thus provides indirect protection.

It’s been rumoured that the government has been leaning towards this plan of action for some time now, although this is the first real admission.

In response to today’s news, experts around the world have been voicing their concerns.

And this isn’t the first time we’ve heard experts say herd immunity is not a good idea.

For example, the head of the World Health Organization said Monday that allowing the novel coronavirus to spread in an attempt to reach herd immunity was “simply unethical.”

Similarly, the National Institutes of Health (NIH) director Francis Collins also denounced herd immunity as a viable plan.

“What I worry about with this is it’s being presented as if it’s a major alternative view that’s held by large numbers of experts in the scientific community. That is not true. This is a fringe component of epidemiology. This is not mainstream science. It fits into the political views of certain parts of our confused political establishment,” he said in an interview.

Not to mention studies continue to show that Sweden’s attempts at herd immunity have failed and have resulted in a higher Covid-19 death toll than expected.

As more research comes out, scientists are starting to learn that Covid-19 immunity, even in those who were severely infected, can fade after a few weeks.

This is why we’ve seen cases of reinfection and why many experts are advising against a herd immunity plan.  

Currently less than 10% of the population in the U.S. are immune to Covid-19 but for herd immunity to be achieved most experts estimate between 40% to 80% of the population would need to be infected.

To put that into context, that means around 197 million people would need to be infected in America. And assuming that the Covid-19 fatality rate is somewhere between 0.5% and 1%, based on numbers from the World Health Organization (WHO), more than 1 million people would die – at minimum.

William Haseltine, Chair and President of ACCESS Health International, told CNN “herd immunity is another word for mass murder. We are looking at two to six million Americans dead – not just this year but every year.”  

This is an unmitigated disaster for our country – to have people at the highest levels of our government countermanding our best public health officials. We know this epidemic can be put under control. Other countries have done it. We are doing the opposite.”

Trying to reach herd immunity is ‘unethical’ and unprecedented, WHO head says

The head of the World Health Organization said Monday that allowing the novel coronavirus to spread in an attempt to reach herd immunity was “simply unethical.”

The remark was a sharp rebuke of the approach amid mounting new infections around the world. Recent days have seen the most rapid rise in cases since the pandemic began in March.

“Never in the history of public health has herd immunity been used as a strategy for responding to an outbreak, let alone a pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said at a Monday media briefing. “It is scientifically and ethically problematic.”

In a public health context, herd immunity typically describes a scenario in which a large enough share of the population is vaccinated against a disease to prevent it from spreading widely, thereby providing default protection to a minority of people who have not been vaccinated.

But as there is still no vaccine for the coronavirus, achieving herd immunity in the current environment would require a large number of people to contract the virus, survive covid-19, and then produce sufficient antibodies to provide long-term protection.

While the scientific community has roundly rejected herd immunity the approach, public interest in it has waxed and waned amid pressure to reopen schools and economies.

Last month, President Trump appeared to praise the idea during a town hall in Pennsylvania.

“You’ll develop herd — like a herd mentality,” he said. “It’s going to be — it’s going to be herd developed — and that’s going to happen.”

British Prime Minister Boris Johnson’s government initially expressed interest in the theory before backtracking amid public outcry over the dangers of letting the virus spread. Johnson himself was hospitalized with a severe case of covid-19, which he said could have killed him.

Tedros, noting that there had been “some discussion” about the concept recently, told reporters Monday that allowing people to be exposed to a deadly virus whose effects are still not fully known was “not an option.”

“Most people who are infected with the virus that causes covid-19 develop an immune response within the first few weeks, but we don’t know how strong or lasting that immune response is, or how it differs for different people,” he said.

Though rare, there are multiple documented instances of people being infected for a second time after recovering from covid-19. An 89-year-old woman in the Netherlands died after being infected with the coronavirus for a second time, Dutch news reported Monday.

Antibody studies suggest that less than 10 percent of people in most countries have contracted covid-19, Tedros said, which is nowhere near the majority that would be needed for herd immunity.

With the “vast majority” of the world’s population susceptible, letting the virus spread “means allowing unnecessary infections, suffering and death,” he said.

Just in the last four days, Tedros said Monday, the global coronavirus count has continued to break its daily record for the number of new confirmed infections.

“Many cities and countries are also reporting an increase in hospitalizations and intensive care bed occupancy,” he added.

Tedros has urged governments to pursue comprehensive plans that include widespread testing, social distancing, and other preventive measures, such as face-mask wearing, alongside a global push to develop a vaccine. The WHO is spearheading an effort to distribute coronavirus vaccines equitably once they are available, which Trump declined to join.

Medical ethics in pandemic times

https://www.axios.com/medical-ethics-clinical-trials-pandemic-eb77f819-76f1-45b0-af8a-cf181bc1607b.html

The Importance of Medical Ethics | Medical Ethics – theMSAG

The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.

The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.

The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?

Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.

  • Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses and creating false hope for patients.
  • And the president’s treatment raised questions about fairness — would other COVID-19 patients have similar access?
  • “It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University. 

He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.

Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.

  • Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
  • One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.

More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.

  • “It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
  • There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
  • But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.

The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.

  • In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
  • “That’s a false dichotomy because the question is, what should we do?” says London.

From a doctor’s perspectiveit’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.

  • “I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
  • “What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
  • “There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
  • She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”

“There is no ethical obligation to give anyone an unproven substance.”

Alison Bateman-House, NYU Grossman School of Medicine

In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”

  • Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
  • The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”

What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.

The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.

Where the virus is spreading

https://www.axios.com/newsletters/axios-vitals-7038a5b1-74fa-44e3-ba7e-43c87052e1c5.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Axios

The Trump administration’s reopening guidelines detail that in order to start lifting restrictions and reopening the economy, a state needs to report 14-day trends of fewer cases or fewer positive tests (though local officials do get some leeway in adjusting the metrics).

  • Not a lot of states meet that criteria, Axios editor-in-chief Nick Johnston writes.

Our chart compares each state’s seven-day average of new cases from Monday and the seven-day average from a week prior, April 27.

  • By this metric, Minnesota, Nebraska and Puerto Rico have the most worrisome trends, while Arkansas and Wyoming have the most positive trends. Twelve states are moving in the right direction.
  • But more than a third of the nation still has growing numbers of cases. And that includes states such as Texas and Virginia, where Republican and Democratic governors are beginning to unveil re-opening plans.

Yes, but: These trends only tell us so much.

  • Some states may see their case counts rise not necessarily because their outbreaks are getting dramatically worse, but because their testing is getting better, so they’re catching more cases.
  • That’s why health officials are also pulling in other metrics — including the number of deaths, the number of hospitalizations and the percentage of tested patients who test positive. A higher percentage means you’re probably missing people.
  • Still, public-health guidance calls for a steady decrease in cases before opening up, and few states have achieved that.

The bottom line: The virus isn’t just some other states’ problem. It’s everyone’s problem.

 

TED Danielle Allen: Here’s how we might save both lives and the economy

Harvard professors take a lively look at love and politics ...

As the coronavirus pandemic sweeps the globe, it’s hard to know where to turn or what to think. TED Connects is a free, live, daily conversation series featuring experts whose ideas can help us reflect and work through this uncertain time with a sense of responsibility, compassion and wisdom.

Danielle Allen serves as Director of the Edmond J. Safra Center for Ethics at Harvard University. The Center seeks to advance teaching and research on ethical issues in public life. Widespread ethical lapses of leaders in government, business, and other professions prompt demands for more and better moral education. More fundamentally, the increasing complexity of public life – the scale and range of problems and the variety of knowledge required to deal with them – make ethical issues more difficult, even for men and women of good moral character. Not only are the ethical issues we face more complex, but the people we face them with are more diverse, increasing the frequency and intensity of our ethical disagreements.

Given these changes in the United States and in societies around the globe, the Center seeks to help meet the growing need for teachers, scholars, and leaders who address questions of moral choice across many of the professions and in public life more generally, and promotes a perspective on ethics informed by both theory and practice. We explore the connection between the problems that professionals confront and the social and political structures in which they act. More generally, we address the ethical issues that all citizens face as they make the choices that profoundly affect the present and future of their societies in our increasingly interdependent world.

https://scholar.harvard.edu/danielleallen/edmond-j-safra-center-ethics

 

 

 

Already Taxed Health Care Workers Not ‘Immune’ From Layoffs And Less Pay

Already Taxed Health Care Workers Not ‘Immune’ From Layoffs And Less Pay

Already Taxed Health Care Workers Not 'Immune' From Layoffs And ...

Just three weeks ago, Dr. Kathryn Davis worried about the coronavirus, but not about how it might affect her group of five OB-GYNs who practice at a suburban hospital outside Boston.

“In medicine we think we’re relatively immune from the economy,” Davis said. “People are always going to get sick; people are always going to need doctors.”

Then, two weeks ago, she watched her practice revenue drop 50% almost overnight after Massachusetts officials told doctors and hospitals to stop performing elective tests and procedures. For Davis, that meant no more non-urgent gynecological visits and screenings.

Late last week, as Davis and her partners absorbed the stunning turn of events, they devised a stopgap plan. The 35 nurses, medical assistants and secretaries they employ would have two options: move from full-time to part-time status or start collecting unemployment. Doctors in the practice would take a substantial pay cut. Davis said she’s hearing from colleagues who may have to permanently close their offices if the focus on crisis-level care continues for months.

“It’s shocking,” she said. “Everyone has been blindsided.”

Atrius Health, the largest independent physician group in Massachusetts, said patient volume is down 75% since mid-March. It is temporarily closing offices, placing many nonclinical employees on furlough and withholding pay for those who remain. The average withholding is 20%, and the company pledges that pay withheld will be returned. The lowest-paid workers, those earning up to $55,000, are exempt.

“What we’re trying to do is piece together a solution to get through the crisis and keep employed as many people as we can,” said Dr. Steven Strongwater, Atrius Health’s CEO.

Atrius cares for 745,000 patients in clinics that often include primary care, specialists, radiology and a pharmacy under one roof.

Strongwater said physician groups must be included when the federal government distributes $100 billion to hospitals from the $2 trillion stimulus package.

It’s not clear if that money will stop the tide of layoffs and lost pay at hospitals as well as in doctor’s offices. A Harvard Medical School physician group will suspend retirement contributions starting April 1.

Beth Israel Lahey Health, the second-largest hospital network in Massachusetts, announced executive pay cuts Monday.

“The suspension of elective procedures and decline in visits to our primary care practices and urgent care centers have resulted in financial challenges,” wrote CEO Dr. Kevin Tabb in an email to employees. Tabb said he would take a 50% salary cut. Other executives and hospital presidents in the system will forgo 20% of their salaries for the next three months.

“Although executive leadership compensation is being reduced, we will never compromise on doing the things that are essential to protect your safety and the safety of our patients,” Tabb told staff.

Dallas-based Steward Health Care has told hospital employees in Massachusetts and eight other states where it operates to expect furloughs focused on nonclinical staff. In a statement, Steward Health Care said it prepared for the pandemic but is experiencing a “seismic financial shock.”

“Elective surgeries are the cornerstone of our hospital system’s operating model — and the negative impact due to the cancellations of these procedures cannot be overstated. In addition, patients are understandably cautious and choosing to defer any nonemergency treatments or routine visits until this crisis has passed.”

Dr. Kaarkuzhali Babu Krishnamurthy, an assistant professor of neurology at Harvard Medical School who studies medical ethics, said employers need to think more carefully about the ethics of asking doctors and nurses to live on less when many are working longer hours and putting the health of their families at risk.

“At a time when health care systems are calling on doctors and nurses to do more, this is not the time to be making it more difficult to do that,” said Krishnamurthy.

There’s talk of redeploying laid-off health care workers to new COVID-19 units opening in shuttered hospitals or to patient overflow sites. Tim Foley, executive vice president for the largest health care union in Massachusetts, 1199SEIU, is promoting the development of a staff registry.

“It is more important, now more than ever, to explore all options to maintain the level of urgent care needed across the state and we look forward to working with all stakeholders to do just that,” Foley said in an email.

 

 

 

 

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 ...

As the coronavirus spreads, the collapse of the project helps explain America’s acute shortage.

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.

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.

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.

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.”

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.

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.

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.

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.

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.

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.”

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.

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.

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.

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.

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.

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 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.

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.”

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.

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.

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.

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.”