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Gry

Gry

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The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed.


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
”https://www.nytimes.com/2020/03/29/...ilator-shortage.html?utm_source=pocket-newtab
 
Gry

Gry

Well-known member
Veteran
Listening to Governors beg for the very medical assistance, that John Bolton did knowingly
dismantle at the President's behest, fits my definition of reprehensible.
 
Gry

Gry

Well-known member
Veteran
When Older Drugs are Better Drugs

Pharmaceutical firms want doctors to use the newest medications on the market—but that’s not always the right choice.

Bill’s world was a dangerous one. He believed that people could control his mind using devices similar to a TV remote. He was not sure who was his friend and who was his foe. I found him curled up in a hospital bed, afraid to step out of his room. As a young man with schizophrenia, he had previously taken a common antipsychotic medication called haloperidol, which was no longer effective. We could have prescribed newer medications, but we wanted to avoid the weight gain that is often associated with these medications. An older, senior doctor on our team suggested we try the medication molindone.
“Molindone? Is that a new medication?” I asked.
“No, quite old,” he said.
Within a week of starting molindone, Bill went from isolated and paranoid to pleasant and cooperative, and he went home soon afterwards.
I marveled at this miraculous transformation. Like many young doctors, I tend to prescribe medications with which I am familiar. For patients with psychosis, I was most comfortable with the so-called second-generation antipsychotics. In medical school we learned about the dreaded side effects of first-generation antipsychotics such as molindone. Most concerning was tardive dyskinesia, a potentially irreversible reaction characterized by involuntary lip-smacking and puckering movements. In clinical practice I rarely see these older medications used, other than for sedation when a patient is agitated, so my default was to prescribe second-generation antipsychotics.
In addition to fewer side effects, psychiatrists were hopeful that second-generation antipsychotics would be more effective for psychotic symptoms than the older ones were. At one point I was taught that these newer medications were more effective for specific psychotic symptoms, such as lack of motivation and decreased sociality. When I began residency I was excited to hear about even newer medications called third-generation antipsychotics. My assumption was that newer was better.
But in fact, newer is not necessarily better, as Bill’s story illustrates. Studies have found little to no difference in efficacy between first- and second-generation antipsychotics in treating the symptoms of schizophrenia. It is true that tardive dyskinesia is less likely to occur with second-generation medications, but the difference is not as much as was previously suggested. Second-generation drugs can also cause weight gain, which is difficult to reverse and increases risk for cardiovascular disease and diabetes. In addition, newer medications are more expensive. As one doctor told me, “With the cost of a 30-day supply of a newer antipsychotic, you could fill a whole room with an old antipsychotic.” These concerns are not unique to psychiatry. There are similar debates in other fields of medicine about the under-prescription of effective older medications for diabetes and hypertension. Personally, I support pharmaceutical innovation, but new medications should add benefit, not just profit.
The trend toward using newer medications often develops during residency training. Pharmaceutical firms market their products to young doctors in all specialties. Whether with free meals, medical tools or travel scholarships, pharmaceutical companies find ways to influence doctors’ prescribing practices. Because most physicians continue recommending the medications they learned in residency, these companies strategically expose residents to newer medications that are still under patent and thus far more profitable for the manufacturers.
Bucking this this trend is not always easy. A month after Bill left the hospital, we learned that the manufacturer of molindone had stopped producing the medication. As mentioned before, the side effects of some older medications can be scary. Side effects loom large because our minds are more sensitive to these adverse events than to benefits. In addition, patients may seek newer medications from their physicians for a variety of reasons—including pharmaceutical ads on TV that tell them to “ask your doctor.”
Although we cannot necessarily force a pharmaceutical company to continue manufacturing a medication, we can urge physicians—particularly younger ones—to be open to prescribing older medications. Working with senior doctors has made me a lot more comfortable with prescribing them. Working overseas, where older medications are the only ones available, has also broadened my knowledge and appreciation of them. Also, if possible, we can track our prescribing practices to increase our awareness of possible bias in favor of new drugs. Electronic health records make this more feasible. My institution recently presented us with our individual and group prescribing patterns, which has made me more conscious of which medications I tend to favor.
As doctors, if we do not learn to prescribe older medications, we miss out on effective alternatives, and our patients and their insurance companies spend more than they need to.
Therefore, if the situation is appropriate, don’t be afraid to try something old.
Kunmi Sobowale is a psychiatry resident at the Yale School of Medicine. He has explored increasing access to mental health care in East and Southeast Asia and for low-income populations in the U.S.
 
M

moose eater

California reported that 170 of the ventilators they received from the Feds arrived already broken. There's a stick in the ol' eyeball, eh?

New ad hominem adjective posted today in the Anchorage Daily News comments section, and perhaps/likely elsewhere; 'Covidiots.'

'Cause, in a pandemic, with a plague of sorts on our hands, broken equipment, and record numbers of healthcare provider suicides, we needed something to toss at each other, other than new masks, gloves, and ventilators.

Harder and harder to find even cynical amusement in any of this.
 
Gry

Gry

Well-known member
Veteran
moose eater said:
California reported that 170 of the ventilators they received from the Feds arrived already broken. There's a stick in the ol' eyeball, eh?

New ad hominem adjective posted today in the Anchorage Daily News comments section, and perhaps/likely elsewhere; 'Covidiots.'

'Cause, in a pandemic, with a plague of sorts on our hands, broken equipment, and record numbers of healthcare provider suicides, we needed something to toss at each other, other than new masks, gloves, and ventilators.

Harder and harder to find even cynical amusement in any of this.
Click to expand...
Very fortunate we are blessed with an abundance of good tech people
that were able to put them back in working order quickly.
 
M

moose eater

Gry said:
Very fortunate we are blessed with an abundance of good tech people
that were able to put them back in working order quickly.
Click to expand...

Very cool. I hadn't seen the follow-up. There's so much news flying around the air right now, that one sentence is interrupted by the beginning of the next, and after a while, it all runs together.

Medscape confirms my earlier prediction, that dedicated persons within the healthcare field, faced with an inability to deliver proper care, broken equipment, few answers, and overwhelming numbers of sick or dying, as well as the removal of carnage for the not-so-fortunate, has resulted in record numbers of healthcare worker suicides and burn-out.

Nothing to be said but, DAMN, sadness has to have a bottom.
 
Gry

Gry

Well-known member
Veteran
Some things never seem to change...

Taxpayers Paid Millions to Design a Low-Cost Ventilator for a Pandemic. Instead, the Company Is Selling Versions of It Overseas.

As coronavirus sweeps the globe, there is not a single Trilogy Evo Universal ventilator — developed with government funds — in the U.S. stockpile. Meanwhile, Royal Philips N.V. has sold higher-priced versions to clients around the world.
https://www.propublica.org/article/...e-company-is-selling-versions-of-it-overseas-


Five years ago, the U.S. Department of Health and Human Services tried to plug a crucial hole in its preparations for a global pandemic, signing a $13.8 million contract with a Pennsylvania manufacturer to create a low-cost, portable, easy-to-use ventilator that could be stockpiled for emergencies.
This past September, with the design of the new Trilogy Evo Universal finally cleared by the Food and Drug Administration, HHS ordered 10,000 of the ventilators for the Strategic National Stockpile at a cost of $3,280 each.
But as the pandemic continues to spread across the globe, there is still not a single Trilogy Evo Universal in the stockpile.
Instead last summer, soon after the FDA’s approval, the Pennsylvania company that designed the device — a subsidiary of the Dutch appliance and technology giant Royal Philips N.V. — began selling two higher-priced commercial versions of the same ventilator around the world.
“We sell to whoever calls,” said a saleswoman at a small medical-supply company on Staten Island that bought 50 Trilogy Evo ventilators from Philips in early March and last week hiked its online price from $12,495 to $17,154. “We have hundreds of orders to fill. I think America didn’t take this seriously at first, and now everyone’s frantic.”
Last Friday, President Donald Trump invoked the Defense Production Act to compel General Motors to begin mass-producing another company’s ventilator under a federal contract. But neither Trump nor other senior officials made any mention of the Trilogy Evo Universal. Nor did HHS officials explain why they did not force Philips to accelerate delivery of these ventilators earlier this year, when it became clear that the virus was overwhelming medical facilities around the world.
An HHS spokeswoman told ProPublica that Philips had agreed to make the Trilogy Evo Universal ventilator “as soon as possible.” However, a Philips spokesman said the company has no plan to even begin production anytime this year.
Instead, Philips is negotiating with a White House team led by Trump’s son-in-law, Jared Kushner, to build 43,000 more complex and expensive hospital ventilators for Americans stricken by the virus.
Some experts said the nature of the current crisis — in which the federal government is scrambling to set up field hospitals in New York’s Central Park and the Jacob K. Javits Convention Center — underscores the urgent need for simpler, lower-cost ventilators. The story of the Trilogy Evo Universal, described here for the first time, also raises questions about the government’s reliance on public-private partnerships that public health officials have used to piece together important parts of their disaster safety net.
“That’s the problem of leaving any kind of disaster preparedness up to the market and market forces — it will never work,” said Dr. John Hick, an emergency medicine specialist in Minnesota who has advised HHS on pandemic preparedness since 2002. “The market is not going to give priority to a relatively no-frills but dependable ventilator that’s not expensive.”
The lack of ventilators has quickly become the most critical challenge to keeping alive many of the people most seriously sickened by the virus. Ventilators not only help people breathe but also can provide pressure that holds the lungs open so the air sacs don’t collapse.
Neither HHS nor Philips would provide a copy of their contract, citing proprietary technical information that would have to be redacted under a Freedom of Information Act request. But from public documents and interviews with current and former government officials, it appears that HHS has at times been remarkably deferential to Philips — and never more so than in the current pandemic.
From the start of its long effort to produce a low-cost, portable ventilator, the small HHS office in charge of the project, the Biomedical Advanced Research and Development Authority, or BARDA, knew that it might need to move quickly to increase production in an emergency and insisted that potential partners be able to ramp up quickly in the event of a pandemic.
But the contract HHS signed in September 2019 gave Philips almost a year before it had to produce a single Trilogy Evo Universal, and two more years to fulfill the order of 10,000 ventilators.
Some experts said the nature of the current crisis — in which the federal government is scrambling to set up field hospitals in New York’s Central Park and the Jacob K. Javits Convention Center — underscores the urgent need for simpler, lower-cost ventilators. The story of the Trilogy Evo Universal, described here for the first time, also raises questions about the government’s reliance on public-private partnerships that public health officials have used to piece together important parts of their disaster safety net.
“That’s the problem of leaving any kind of disaster preparedness up to the market and market forces — it will never work,” said Dr. John Hick, an emergency medicine specialist in Minnesota who has advised HHS on pandemic preparedness since 2002. “The market is not going to give priority to a relatively no-frills but dependable ventilator that’s not expensive.”
The lack of ventilators has quickly become the most critical challenge to keeping alive many of the people most seriously sickened by the virus. Ventilators not only help people breathe but also can provide pressure that holds the lungs open so the air sacs don’t collapse.
Neither HHS nor Philips would provide a copy of their contract, citing proprietary technical information that would have to be redacted under a Freedom of Information Act request. But from public documents and interviews with current and former government officials, it appears that HHS has at times been remarkably deferential to Philips — and never more so than in the current pandemic.
From the start of its long effort to produce a low-cost, portable ventilator, the small HHS office in charge of the project, the Biomedical Advanced Research and Development Authority, or BARDA, knew that it might need to move quickly to increase production in an emergency and insisted that potential partners be able to ramp up quickly in the event of a pandemic.
But the contract HHS signed in September 2019 gave Philips almost a year before it had to produce a single Trilogy Evo Universal, and two more years to fulfill the order of 10,000 ventilators.
On the same day in July that the FDA cleared the stockpile version of the ventilator, it granted the application of Philips’ U.S. subsidiary, Respironics, to sell commercial versions of the Trilogy Evo. Philips quickly began shipping the commercial models overseas from its Murrysville, Pennsylvania, factory.
Steve Klink, the company’s Amsterdam-based spokesman, said Philips was within its rights under the HHS contract to prioritize the commercial versions of the Trilogy Evo. An HHS spokeswoman — who insisted she could not be identified by name, despite speaking for the agency — did not disagree.
“Keep in mind that companies are always free to develop other products based on technology developed in collaboration with the government,” she said in a statement to ProPublica. “This approach often reduces development costs and ensures the product the government needs is available for many years.”
Just last month, HHS gave a very different impression to Congress, hailing the Trilogy Evo it funded as a breakthrough in its campaign for pandemic preparedness.
“This game-changing device, considered a pipedream just a few years ago, is now available at affordable prices to improve stockpiling and deployment” in an emergency, the agency told Congress in a budget document delivered on Feb 10.
But less than two weeks later, officials overseeing the Strategic National Stockpile approached Philips with an urgent appeal: Start making our ventilators. On March 10, Philips agreed to a modification of the HHS contract — one that called for the company to produce the Trilogy Evo Universal “as soon as possible,” a spokesperson said.
However, in a subsequent statement, the HHS spokeswoman said Philips is only required to deliver the ventilators “as they are completed.” Klink, the company spokesman, said Philips was only committed to meeting the original contract deadline of 10,000 ventilators by September 2022.
Had government officials insisted that Philips first produce the ventilators that taxpayers paid to design, the government could conceivably be distributing all 10,000 to hospitals now. Last year, Philips plants in Pennsylvania and California produced 500 ventilators of various models per week; they sped up to 1,000 per week earlier this year, Klink said. At that pace, the stockpile ventilators could have been completed even if Philips devoted only part of its lines to their production.
Klink said the reason the company is not producing the stockpile ventilator is because it has not yet been mass-produced and would require time-consuming trial runs. In the current crisis, it’s faster and more efficient to continue producing the versions it is already making, he said.
Asked if Philips could hand over its Trilogy Evo Universal design to another manufacturer, he argued that the fundamental constraint on production is not the company’s assembly lines but its dependence on more than 100 smaller companies around the world that make the 650 parts needed for a hospital ventilator.
“We cannot sell a ventilator with only 649 parts,” he said. “It needs to be the whole 650.”
It is difficult to assess how much profit motives might be driving Philips’ decisions about which ventilators to produce because the company does not disclose how much it charges different clients for commercial modelsOn the same day in July that the FDA cleared the stockpile version of the ventilator, it granted the application of Philips’ U.S. subsidiary, Respironics, to sell commercial versions of the Trilogy Evo. Philips quickly began shipping the commercial models overseas from its Murrysville, Pennsylvania, factory.
Steve Klink, the company’s Amsterdam-based spokesman, said Philips was within its rights under the HHS contract to prioritize the commercial versions of the Trilogy Evo. An HHS spokeswoman — who insisted she could not be identified by name, despite speaking for the agency — did not disagree.
“Keep in mind that companies are always free to develop other products based on technology developed in collaboration with the government,” she said in a statement to ProPublica. “This approach often reduces development costs and ensures the product the government needs is available for many years.”
Just last month, HHS gave a very different impression to Congress, hailing the Trilogy Evo it funded as a breakthrough in its campaign for pandemic preparedness.
“This game-changing device, considered a pipedream just a few years ago, is now available at affordable prices to improve stockpiling and deployment” in an emergency, the agency told Congress in a budget document delivered on Feb 10.
But less than two weeks later, officials overseeing the Strategic National Stockpile approached Philips with an urgent appeal: Start making our ventilators. On March 10, Philips agreed to a modification of the HHS contract — one that called for the company to produce the Trilogy Evo Universal “as soon as possible,” a spokesperson said.
However, in a subsequent statement, the HHS spokeswoman said Philips is only required to deliver the ventilators “as they are completed.” Klink, the company spokesman, said Philips was only committed to meeting the original contract deadline of 10,000 ventilators by September 2022.
Had government officials insisted that Philips first produce the ventilators that taxpayers paid to design, the government could conceivably be distributing all 10,000 to hospitals now. Last year, Philips plants in Pennsylvania and California produced 500 ventilators of various models per week; they sped up to 1,000 per week earlier this year, Klink said. At that pace, the stockpile ventilators could have been completed even if Philips devoted only part of its lines to their production.
Klink said the reason the company is not producing the stockpile ventilator is because it has not yet been mass-produced and would require time-consuming trial runs. In the current crisis, it’s faster and more efficient to continue producing the versions it is already making, he said.
Asked if Philips could hand over its Trilogy Evo Universal design to another manufacturer, he argued that the fundamental constraint on production is not the company’s assembly lines but its dependence on more than 100 smaller companies around the world that make the 650 parts needed for a hospital ventilator.
“We cannot sell a ventilator with only 649 parts,” he said. “It needs to be the whole 650.”
It is difficult to assess how much profit motives might be driving Philips’ decisions about which ventilators to produce because the company does not disclose how much it charges different clients for commercial models.
The commercial version of the Trilogy Evo has had its own problems. Not long after it began selling the ventilators last summer, Philips sent out recall notices to customers in Europe and the U.S., alerting them to a software glitch that prompted the devices to shut down without sounding their alarm. The software has since been updated and the problem solved, the company said.
Klink said Philips hopes to be making 4,000 ventilators of all types each week in the U.S. by October, and that it would prioritize “those communities and countries that need it the most.”
But as the pandemic spreads, desperate global demand for the commercial models of the Trilogy Evo is driving up prices sharply, and evidence from the chaotic open market for the devices raises questions about Philips’ stated commitment to prioritize the neediest.
On Staten Island, a saleswoman at No Insurance Medical Supplies, who would give her name only as Jeanette, said the company was selling to “anyone who calls,” including doctors and individuals. The company’s first shipment of 50 devices sold out quickly, but an additional five ventilators arrived on Friday. The company requested 148 more, but Philips Respironics said it could only provide 11 ventilators by April 6, she said. The company’s prices are determined by what the manufacturer charges, she said.
The competition abroad is also intense. On March 12, the regional government of Madrid, one of the cities hardest hit by the virus, bought 10 Trilogy Evo ventilators from a Spanish medical supply company for about $11,000 each. In Budapest, Hungary, the Uzsoki Street Hospital announced that a local property development company had donated two “ultra-modern” Philips Trilogy Evo ventilators on March 18.
The struggle has grown so fierce that last week, a trade group representing ventilator manufacturers asked the head of the Federal Emergency Management Agency to decide for the manufacturers whom they should sell to first.
“We would appreciate the Administration’s leadership and the advice of clinical and other experts within the Administration in deciding how to allocate these products in the most effective way,” the Advanced Medical Technology Association wrote in a letter to FEMA Administrator Peter Gaynor.
Medical experts and public health officials have believed for nearly two decades that they needed a less-expensive and simpler-to-operate portable ventilator that could be made and distributed quickly in an emergency.
“This is not a new problem,” said W. Craig Vanderwagen, a former senior HHS official who oversaw studies that led to the government’s early efforts to design and build a low-cost portable ventilator for such eventualities. “We knew back in the 2000s that ventilators were going to be critical in pandemic preparedness. That was a clear gap that we identified.”
In the early 2000s, American public health experts and government officials were gripped by a sense of urgency they had not felt before. The 9/11 attacks and the anthrax scare that followed underscored the need for sweeping new actions to keep the country safe. Outbreaks of Avian influenza — first reported in Hong Kong in 1997 — exposed the public health system’s vulnerability to new, highly fatal pathogens from overseas. The George W. Bush administration’s disastrously slow and inept response to Hurricane Katrina in 2005 prompted widespread calls for the government to strengthen its ability to deal with a growing array of emergencies, from new, highly contagious diseases to previously unthinkable terrorist attacks.
One obvious vulnerability was to a viral pandemic or a chemical or biological attack that would ravage the lungs of its victims, setting off a cascade of cases of what doctors call Acute Respiratory Distress Syndrome, or ARDS.
“None of us expected an event on the scale of what we’re going through now,” said Dr. Lewis Rubinson, a pulmonologist who participated in several of the early government-sponsored medical studies. “We had to guess: What would the patients look like? What we predicted correctly was that we could face massive cases of ARDS.”
By the early 2000s, officials at the Centers for Disease Control and Prevention had already begun working to stockpile a few thousand ventilators for such an eventuality, former officials said. But studies by medical experts and government scientists — including sophisticated models of what might occur in the event of various disasters, outbreaks or attacks — suggested a bigger problem. Hospitals could be crippled not only by shortages of complex and costly ventilators, but also by a lack of the trained respiratory technicians who are generally required to operate the machines.
The experts envisioned one important solution: a portable ventilator that was less complex than hospital machines and could be more quickly produced, safely stockpiled and widely distributed in emergencies. They envisioned a device that could be deployed in field hospitals like the ones that authorities are now rushing to create in Central Park and elsewhere.
The job of bringing such a device to life fell to BARDA, an innovative office of HHS that was established in 2006 to help the country prepare for pandemic influenza, new types of infectious diseases or an attack or accident involving chemical, biological or radiological weapons.
Much of BARDA’s work has been focused on developing potentially critical vaccines and other medicines that are not necessarily profitable for big pharmaceutical companies. The agency often works with medical researchers at the National Institutes of Health and elsewhere, identifying promising therapies and other innovations, and then forms partnerships with private biotechnology or other companies to create the drugs and move them through various stages of regulation.
In 2008, BARDA began trying to find a company that could make a ventilator that would be inexpensive — ideally, less than $2,000 each — and could be simple enough to use that “inexperienced health care providers with limited or no respiratory support training” could operate the devices during a pandemic, according to the agency’s solicitation for bids.
BARDA also anticipated the shortage of parts and competing priorities that the ventilator industry now faces. Companies bidding for the contract had to show they could secure the parts needed to “ramp up production to supply at least” 1,700 ventilators per month and 10,000 in six months’ time. The companies also had to pledge that government “contracts will be honored during a pandemic,” the initial solicitation said.
With only a couple of bids, BARDA settled on a small, privately held ventilator company in Costa Mesa, California, Newport Medical Instruments Inc. BARDA and Newport signed a $6.4 million contract in September 2010, specifying that the money would be doled out incrementally as the company met various milestones.
But in May 2012, Newport was purchased by a larger Irish medical device company, Covidien, for $108 million. Covidien quickly downsized and asked Rick Crawford, Newport’s former head of research and development and the lead designer of the BARDA ventilator, to finish up the project without any staff assigned to him. Crawford said he took a job with another company.
“I don’t know how you finish a project when nobody reports to you,” he recalled thinking.
A former BARDA official who worked on the project said that Covidien began raising issue after issue and demanded more money. BARDA agreed, eventually tacking on almost $2 million more to the price tag, records show. Even so, Covidien abandoned the project.
A spokesman for the still-larger firm that acquired Covidien in 2015, Medtronic, said that the prototype ventilator created by Newport Medical “would not have been able to meet the specifications required by the government, nor at the price required.” In a statement responding to a story in The New York Times, Medtronic said it left the federal government with all the designs and equipment created in the project.
Several former BARDA officials said such outcomes come with their territory. Like big pharmaceutical companies, they had to take chances, especially in the development of vaccines.
“There are going to be risks like that when you partner with businesses,” said one former senior BARDA official, who, like others, asked for anonymity because she was not authorized to speak for the agency. “It’s a problem that we at BARDA had encountered before, where a company changed hands and changed priorities.”
In March 2016, less than two years after signing its ventilator contract with BARDA, Philips Respironics agreed to pay $34.8 million to settle a Justice Department lawsuit under the False Claims Act and the Anti-Kickback Statute. Justice lawyers accused the manufacturer of effectively paying kickbacks to medical suppliers to buy its masks for sleep apnea. The company also agreed to abide by a five-year Corporate Integrity Agreement with HHS inspector general that imposed a series of oversight measures on the company’s operations.
With BARDA’s continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. Klink, the Philips spokesman, said the $13.8 million from HHS covered only a portion of the design and development costs for the ventilator and that the company invested more.
Rubinson, now the chief medical officer of Morristown Medical Center in Morristown, New Jersey, praised the BARDA effort as essential, adding that if 10,000 ventilators seems like a small number in the COVID-19 crisis, it had to be understood in the context of government officials’ typical unwillingness to buy equipment it might only need in an emergency.
“They could have bought a million ventilators,” he said. “And then you would be writing about the boondoggle of all these devices that never got used.”
Today, the government’s failure to obtain the Trilogy Evo Universal is seen by some experts as the real game changer.
“Even if a few months ago we had taken dramatic action to develop these kinds of ventilators, it would have been better,” said Hick, the emergency medicine specialist in Minnesota. “If I had a ventilator that cost $4,000 rather than $16,000, I’d be in better shape. We can buy a lot more of them.”
Claire Perlman contributed reporting.
 
Gry

Gry

Well-known member
Veteran
Trilogy Evo
DS2110X11B

The next generation of the Philips Trilogy portable life support ventilator is designed to stay with your patients wherever they go. Now with 15-hour battery life compared to Trilogy 100's six-hour battery.




Expanded cross-functionality
Now with 16-hour battery life

Extended battery provides new level of freedom

Supported by both internal and detachable batteries.




New features include:

8" touchscreen with patient friendly displays

On-screen Help and Alarm guidance and user-friendly universal names for most ventilator modes. Easy set-up and modification.








Features designed to treat chronic and critical patients

Works across sub-acute or chronic care environments, a patients' home or during activities. Designed with durability in mind to protect it against damage during travel.
 
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