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Flu Nightmare: In Severe Pandemic, Officials Ponder Disconnecting Ventilators From Some Patients

With scant public input, state and federal officials are pushing ahead with plans that -- during a severe flu outbreak -- would deny use of scarce ventilators by some patients to assure they would be available for patients judged to benefit the most from them.

The plans have been drawn up to give doctors specific guidelines for extreme circumstances, and they include procedures under which patients who weren’t improving would be removed from life support with or without permission of their families.

The plans are designed to go into effect if the U.S. were struck by a severe flu pandemic comparable to the 1918 outbreak that killed an estimated 50 million people worldwide. State and federal health officials have concluded that such a pandemic would sicken far more people needing ventilators than could be treated by the available supplies.

Many of the draft guidelines, including those drawn up by the Veterans Health Administration, are based in part on a draft plan New York officials posted on a state Web site two years ago and subsequently published in an academic journal. The New York protocol, which is still being finalized, also calls for hospitals to withhold ventilators from patients with serious chronic conditions such as kidney failure, cancers that have spread and have a poor prognosis, or "severe, irreversible neurological" conditions that are likely to be deadly.

New York officials are studying possible legal grounds under which the governor could suspend a state law that bars doctors from removing patients from life support without the express consent of the patient or his or her authorized health agent.

State and federal officials involved with drafting the plans say they have been disquieted by this summer’s uproar over whether Medicare should pay for end-of-life consultations with families. They acknowledged that the measures under discussion go far beyond anything the public understands about how hospitals might handle a severe pandemic.

By every indication, state and federal officials expect to weather this year’s flu season without having to ration ventilators. That assumes that the H1N1 virus will not mutate into a more serious killer, that the vaccines against it and the other seasonal flus will continue to prove effective, and that any dramatic surges in the number of patients in need of ventilators will occur in different parts of the U.S. at different times.

In recent months, New York officials have met three times with physicians, respiratory therapists and administrators to rehearse how their plan might play out in hospitals in a severe epidemic. In one of those “tabletop exercises,” participants suggested that the names of triage officers charged with making life and death choices among patients at each hospital should be kept secret. The secrecy would be needed, participants said in interviews, to avoid pressure and blame from colleagues caring for patients who were selected to be taken off life support.

When they posted their plan on the Web in coordination with a video conference in 2007, New York officials promised to solicit public input. Since then, they have consulted with medical and legal professionals and other experts, but few members of the general public, and the plan has remained unchanged. They declined to make the comments they have gathered immediately available for review, and those comments are not published on the Health Department's Web site.

In the initial proposal, officials called public review “an important component in fulfilling the ethical obligation to promote transparency and just guidelines.”

The academic publication of the plan envisaged the use of focus groups to solicit comment from “a range of community members, including parents, older adults, people with disabilities, and communities of color.” Those have not been held.

Beth Roxland, the current executive director of the New York State Task Force on Life and the Law, said the ethicists included in the state's planning process focused largely on vulnerable populations. "Even if we didn’t have direct input from vulnerable populations," she said, "their interests have been well accounted for." Roxland said that public comment solicited when the ventilator plan was posted on the Health Department Web site was "sparse."

Dr. Guthrie Birkhead, Deputy Commissioner of the Office of Public Health for New York state, said he wondered whether it was possible to get the public to accept the plans. "In the absence of an extreme emergency, I don’t know. How do you even engage them to explain it to them?"

Even so, other states, hospital systems and the Veterans Health Administration—which has 153 medical centers across all states -- have drafted protocols that are based in part on New York’s plan. The inclusion and exclusion criteria for access to ventilators, however, are different. For example, under the current drafts, a patient on dialysis would be considered for a ventilator in a VA hospital in New York during a severe pandemic, but not in another New York hospital that followed the state’s plan, which excludes dialysis patients. The VA’s exclusion criteria are looser because the patient population it is charged with serving is typically older and sicker than in other acute care hospitals. Different states, reflecting different values, have also established different criteria for who gets access to lifesaving resources.

The Institute of Medicine, an independent national advisory body, is expected to release a report on Thursday morning, at the request of the U.S. Department of Health and Human Services, that will recommend broad guidelines to help guide planners crafting altered standards of care in emergencies. At an open meeting held to inform the report on Sept. 1, participants described successful public exercises related to allocating scarce resources in Utah and in a Centers for Disease Control and Prevention study conducted in Seattle.

Questions about how hospitals would handle massive demand for life support equipment arose when New York state health department officials ran exercises based on a scenarios involving H5N1 avian influenza.

“They kept running out of ventilators,” said Dr. Tia Powell, director of the Montefiore-Einstein Center for Bioethics and former executive director of the New York State Task Force on Life and the Law, which was asked to address the problem. “They immediately recognized this is the worst thing we’ve ever imagined. What on earth are we going to do?”

Officials calculated that 18,000 additional New Yorkers would require ventilators in the peak week of a flu outbreak as deadly as the 1918 pandemic. Only a thousand machines would be available, the officials estimated. The state’s acute care hospitals in 2005 had about 6,000 ventilators, 85 percent of which were normally in use. A moderately severe pandemic would have resulted in a shortfall of 1,256 ventilators, health officials found.

In 2006, New York planners convened a group of experts in disaster medicine, bioethics and public policy to come up with a response. After months of discussion, the group produced the system for allocating ventilators. They first recommended a number of ways that hospitals could stretch supply, for example by cancelling all elective surgeries during a severe pandemic. The state has also since purchased and stockpiled 1,700 Pulmonetic Systems LTV 1200 ventilators (Cardinal Health Inc., NYSE) -- enough to deal with a moderate pandemic but not one of 1918 scale.

Officials realized those two measures alone would not be enough to meet demand in a worst-case scenario. Ventilators were costly, required highly trained operators, and used oxygen, which could be limited in a disaster.

The group then drew up plans for rationing of ventilators. The goal, participants said, was to save as many lives as possible while adhering to an ethical framework. This represented a departure from the usual medical standard of care, which focuses on doing everything possible to save each individual life. Setting out guidelines in advance of a crisis was a way to avoid putting exhausted, stressed front-line health professionals in the position of having to come up with criteria for making excruciating life and death decisions in the midst of a crisis, as many New Orleans health professionals had to do after Hurricane Katrina.

The group based its plans, in part, on a 2006 protocol developed by health officials in Ontario, Canada, which relied on quantitative assessments of organ function to decide which patients would have preference for an intensive care unit bed. The tool, known as the Sequential Organ Failure Assessment (SOFA) score, is not designed to predict survival, and not validated for use in children, but the experts adopted it in light of the lack of an appropriate alternative triage system.

This summer, New York officials brought the state’s plan to groups from several New York hospitals for the tabletop exercises. They met behind closed doors to assess how hospitals might implement the proposed measures if the H1N1 pandemic turned unexpectedly severe this fall. In the fictional scenario, paramedics were ordered not to place breathing tubes into patients until physicians “can assess whether they meet the criteria to be placed on a ventilator.’’

Problems were immediately apparent. Dr. Kenneth Prager, a professor of medicine and director of clinical ethics at Columbia University Medical Center, was concerned about the lack of awareness of the plan among the larger public and the majority of the medical community. Societal input “is totally absent,” he said and called for more outreach to the public. “Maybe society will say:  'We don’t agree with your plan. You may think it’s ethically OK; we don’t.' "

The protocol, he said, would also place a great burden on clinicians charged with selecting which patients would be removed from life support. Physicians were concerned doctors involved in the legitimate and painful selection processes might be inappropriately construed as "death squads." “We facetiously dubbed them the ‘death squad’ or the ‘guys in the back room,’ ” Prager said. He envisioned family members breaking down and screaming when they found out their loved ones would be disconnected from ventilators. “It really is a nightmare.”

Even so, he felt that the plan – and its effort to save the greatest number of patients – was ethically appropriate. “If we don’t use triage, people will die who would have otherwise been saved,” he said, because a number of ventilators are “being used to prolong the dying process of patients with virtually no chance of surviving.”

Doctors at the exercises feared that they would be sued by angry patients if they followed the draft guidelines. “There’s absolutely no legal backing for physicians,” said Lauren Ferrante, a medical resident at Columbia University Medical Center. “Who’s to say we’re not going to get sued for malpractice?”

New York State law prohibits doctors from removing living patients from ventilators or other life support except in cases where the patient has clearly stated such wishes, for example in a living will, or through his or her legal health care agent. Other sources of liability could come from federal and state anti-discrimination laws or claims of denial of due process.

New York officials said they were currently working out legal options for implementing the plans, such as gubernatorial emergency declarations or emergency legislation.

“You can take something today that’s not necessarily active and overnight flip the switch and make it into something that has those teeth in it,” said Dr. Powell, who served on the committee that drafted the plan.

Dr. Powell cautioned that it is critically important to maintain flexibility in the guidelines. Any rationing measures taken in a disaster must be calibrated to need and severity.

Guidelines can also promote investment in new technology, such as cheaper, easier to use ventilators, that would make rationing less likely. Already, at least one company, St. Louis-based Allied Healthcare Products, is marketing a line of ventilators specifically for use in disasters.

Some states, including Louisiana and Indiana, have adopted laws that immunize health professionals against civil lawsuits for their work in disasters. Other states, including Colorado, have drawn up a series of relevant executive orders that could be applied to address these issues.

Dr. Carl Schultz, a professor of emergency medicine at the University of California at Irvine and co-editor of the forthcoming textbook, "Koenig and Schultz’s Disaster Medicine" (Cambridge University Press), is one of the few open critics of the establishment of altered standards of care for disasters. He says the idea “has both monetary and regulatory attractiveness” to governments and companies because it relieves them of having to strive to provide better care. “The problem with lowering the standard of care is where do you stop? How low do you go? If you don’t want to put any more resources in disaster response, you keep lowering the standard.”

Federal officials disagree. “Our goal is always to provide the highest standard of care under the circumstances,” said Rear Adm. Ann Knebel, deputy director of preparedness and planning at the Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services. “If you don’t plan, then you are less likely to be able to reuse, reallocate and maximize the resources at your disposal, because you have people who’ve never thought about how they’d respond to those circumstances.”

Fix it!

The odd timing and coincidence of this “nightmare” scenario cannot be overlooked.

It sounds like the only thing missing from what New York officials, the Institute of Medicine, the Veterans Administration, and the U.S. Department of Health and Human Services have figured out a way to act and make decisions as if there were “death panels” without actually needing them.

Sadly, the only thing standing between sanity and the sanctity for human life is Dr. Carl Schultz, Professor of Emergency Medicine at the University of California at Irvine.  His argument against what “...officials are pondering” should be required reading for everyone.

Silly me - I thought all the hysteria over “death panels” were the just the imagined paranoia of extremely loose right wingnuts.

How disturbing to find we don’t need the panels to make the same kinds of decisions.

As a physician of some thirty years I just am having trouble knowing what to say about this article.  First I had to struggle with my degree of trust in ProPublica itself.

The article seemed to be of that form that are meant to test the waters against some idea (a somewhat old fashioned technique compared with modern propaganda methods).  I decided that the true provenance of the article was something that could not be known.  On the other hand, I do believe the “facts” presented in the piece.  Mass mental illness in the form of elite panic can be a fact too.

I was reminded of Reverand Neimoler’s famous “poem,” from which so many wonderful paraphrasings have sprung,

“When Hitler attacked the Jews
I was not a Jew, therefore I was not concerned.
And when Hitler attacked the Catholics,
I was not a Catholic, and therefore, I was not concerned.
And when Hitler attacked the unions and the industrialists,
I was not a member of the unions and I was not concerned.
Then Hitler attacked me and the Protestant church—
and there was nobody left to be concerned.”

http://scott.hayes.org/thoughts/niemoller.html

But technically speaking, I think the National Socialist went after the chronically ill first.  There were offices staffed with doctors selecting patients for euthanasia. Movements are like that.  They tend to start with the lowest hanging fruit.

A new paraphrasing might start,

First they came for those on respirators….

But the imagination of the fascist mind aside, the proposition itself is so much manure. There are many options, including taking old iron lungs out of mothballs.

Twenty two years ago I had the pleasure of being a visiting doctor in the pediatric wing of the Nha Trang District Hospital, Nha Trang, Viet Nam.  They presented me with their miracle child, a premature born at 24 weeks gestation at less than 600 gm (a little over a pound) with eyes still fused.  This is an infant that likely would have been considered “pre-viable” in the US at the time and likely would have been left to expire. I have had to do this myself unfortunately, when, as a pediatrician, I could not intubate such a small infant (because the trachea was too small to allow for ventilation and no effective measures were available).

In Nha Trang the hospital had NO modern equipment, no ventilators, nothing that I was used to using in my practice back in the states at the time. What they had done was to organize a team of trained people to hand ventilate (with a bag and a mask squeezing air in with their hands) this “pre-viable” infant for months until it was able to start breathing on its own.  During that time they fed the infant a homemade neonatal formula out of available foodstuffs like coconut milk (I don’t remember the recipe, but I remember being impressed by their resourcefulness).  But what they were showing me was a healthy premature baby, growing well, smiling, and with that strange head shape that extreme prematures get that is so cute.  A baby that would not have survived as a routine matter in the US at that time.  Of course they credited the baby’s luck for not having developed any of a host of other problems that such small prematures usually die from.  Their miracle baby.

So, what all the experts are saying is not that they will be “forced” to let folks die, it is that they don’t have the will to do otherwise.  Life itself has become a lottery. I hear that Wall Street is now speculating on peoples life insurance policies in structured CDOs instead of bogus mortgages.  Could there be a connection? Is Wall Street betting that many people are going to die prematurely? Stay tuned and find out.

Herb Ruhs, MD
Missoula, MT

Clarence Graansma

Sep. 24, 2009, 7:39 a.m.

Sheri,
I have been following this issue very closely for the past two and a half years.  I remember when the New York group was drafting its guidelines and asking for public input.  I submitted my ideas to them at that time, but I never received any requests for more input or clarification. 

I run the Pandemic Ventilator Project (http://www.panvent.blogspot.com). A small group (just 3 people right now) who are designing and building ventilators and prototypes so that additional ventilators could be built from readily available materials during a pandemic if the stockpiled ventilator quantities are not sufficient in a pandemic.  I also put out ideas for ways that the use of the existing stocks of ventilators and equipment can be put to better use.  We draw inspiration from the brave individuals that built iron lung ventilators from wooden boxes and vacuum cleaners during the polio epidemics from the late 1930s to the early 1950s.  These individuals did not accept that they would let one child die and the other one live only because there was no ventilator.

This project may sound a little far fetched to many people, but we believe that with the major advances in the last few years in the capabilities of modern sensing and control systems that are available “off the shelf” for today’s automated manufacturing equipment, that we can overcome the design obstacles and produce viable ventilator designs that are open source, and free for anyone to use in a crisis. (But only in a crisis.)

This article you wrote is one of the most comprehensive, balanced and well written pieces I have read so far on this subject.  I hope that it is widely read by the public, as well as planning and “deciding” individuals.  I am pleased that you have published under Creative Commons, as my work is as well.  I will be recommending it and will be reprinting it on my blog.

Clarence Graansma

I am a medical professional.  Just last week we had a “Webinar” conference on treating very sick patients with H1N1/Swine Flu on ventilators.  I am also on a medical list which has critical care docs from Australia, New Zealand, Brazil—-countries which just had their winter flu season with H1N1.  Assuming the virus doesn’t mutate into anything more lethal what looks like is that, while the total numbers of people dying is about on a par with a regular influenza season, we will be seeing more young people on ventilators with very severe lung disease.  And that the conventional ventilators alone won’t suffice to save these patients.  More sophisticated, more rarely used ventilators called “Oscillators” will be needed to be used. Patients are being placed on their stomachs to open up the lung bases, and even needing ECMO——where venous blood is oxygnated outside the lungs. 

So, as regards the projected H1N1 season it doesn’t look like we’ll be faced with triage of regular ventilaotors.  However centers which do treat pediatric ICU patients may be overwhelmed.  And many smaller community hospitals would be totally out of their league to provide HFOV/ECMO, etc. 

At the end of the Webinar they mentioned the disaster preparations dealing with triage of available ventilators.  Right away I saw this as another opportunity for the fringe right to use this to stoke the “Death Panel” fires.  This need to come up with some advance triage directive and planning has been underfoot for quite some time.  But now everything to do with “The Feds” is being spun for effect.  Now the spin can be “Obama wants to create Secret Death Panels so that grandpa can be taken off and left to die so some illegal immigrant kid will be put on”. 

But I am glad this article was written and it’s being publicly discussed, even as I groan in advance at the all to predictable spin. 

Imagine a calibration of this.  A terrible pandemic is overrunning the supply of ventilators in every corner of the country.  At one hospital the one-for-one choice comes down between…

90 year old wealthy post surgical patient AVR/CABG.  Is now two weeks out from surgery and the patient is still on the ventilator.  The kidneys have shut down and the patient is on continuous dialysis. The lungs are needing high levels of pressure and oxygen just to tread water with survival, and the cardiovascular system is needing lots of drugs just to keep the blood pressure up.  Every experienced critical care professional thinks that the dying process is just being prolonged by keeping the patient in the ICU and on all the machines.  But the family has over the years made generous contributions to the hospital fund.  The surgeon who performed the operation never “gives up”.  The family insists that their relative “is a fighter” and wants “everything done”. 

Meanwhile down in the ER an 18 year old illegal immigrant has just had to have a breathing tube inserted.  The respiratory therapist is hand ventilating the patient and there are no other ventilators available.  The “Secret Death Panel” has decided that the former described patient is to be removed from the ventilator and given drugs to maintain comfort only.  The ventilator will then be used in an attempt to save the life of the 18 year old illegal immigrant. 

The relatives are informed.  The next of kin hears who is the person to next get the ventilator.  He is the head of a very vocal and militant anti-immigrant organization.  Calls to out to rally the troops in protest.  Family members gather in the room and sit down in protest of the imminent removal, with the surgeon in attendance verbally supporting their stand.  The police in attendance call for reinforcements. …

Meanwhile for your entertainment..

http://www.funnyordie.com/videos/e357e52d41/death-panel-advisors?rel=auto_related&rel_pos=2

Great post Jeff,

Of course what is missing in this discussion, glaringly, is input from people who actually know about intensive care.  Gosh, what is going to happen when, and if from the point of view of the pirates who own the country, folks actually begin to realize how completely they have been screwed?

Another aspect of this discussion is that the real question is who gets access to ALL the care they need to survive, not just the ventilator.  They may find the door to the ICU blocked by a hospital employed “hospitalist” with their primary doc standing by helpless to intervene. My wife’s hospital (a large mountain region hospital) is openly making plans to limit admitting priviledges to a small group of their employed physician “hospitalist.” Our family may end up doing intensive care in our home out of despriation.  It has happend before and seems ever more likely.  Stocking up on needed supplies.

herb

This is indeed an important public policy issue that should be widely discussed.

Of course, it’s also painfully obvious that if there aren’t enough ventilators (or any other equipment or medicine or staff) to go around, someone is going to go without.

I wonder though, what would the lead of the story have been if health care officials DIDN’T have draft plans for dealing with a shortage? Maybe something like: “In a flu crisis, patients who could be saved may die because a first-come, first-served allocation system means some scarce ventilators would be connected to patients who are unlikely to survive.”

Would that be better?

When examining a policy, it is important to include the question: “What are the alternatives?”

“When examining a policy, it is important to include the question: “What are the alternatives?”

One alternative would be to do something about the anticipated need right away, but I forget.  This USA, Planet Earth and not Vulcan where they respond rationally to emergencies.  No, the operative approach here is to talk about the problem until it goes away, like the levies in New Orleans did.  Who after all is really going remember the dead in the midst of a whole tidal wave of decaying services and infrastructure, joblessness, bankruptcy and homelessness?  Maybe a few of us little people might remember that grandma got iced just after her surgery, but undoubtedly we will be confused about it.  After all, the nice doctor said they did everything they could.

Herb Ruhs, MD
Missoula, MT

Lots of things in the mix.

Rational discussions and planning for a truly major pandemic/disaster.

Lots of milking the system post 9/11 and the whole Disaster Capitalism described by Naomi Klein.  It’s not just the big players—-little cottage industries setup (we have a group of firefighters soak the hospital to meet some state mandate for hazardous waste exposure—-it was a mini-disaster unto itself.

All the Dwight Shrutes (weirdo survivalist type on The Office) coming out of the woodwork—-both in planning and implementation stages.

Vendors taking advantage to sell their wares—stockpiling vents, using regulations to force hospitals to buy or implement.  Sometimes good but too often people gaming the regulatory system. 

Legitimate concern that this issue isn’t being discussed publicly enough. 

Valid recognition that any taking of this to a public forum will then lead to polices sugar coated and not based in the real needs of a truly dire pandemic/disaster.

Stoking the “Death Panel” angle on this.

Meanwhile at hospitals across the country we can barely handle what we have per our resources and staffing guidelines.

Let’s just all take a minute or two to scream our heads off in response to this.  Verbal behavior doesn’t seem to be working and at least the screaming is healthy.

herb

This article is part of an ongoing investigation:
.

Disaster Medicine

Doctors and ethicists wrestle with questions about rationing care during a disaster or epidemic.

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