Your Chance to Weigh In on Ventilator Rationing for a Severe Flu Pandemic

by Sheri Fink, ProPublica

On Monday, ordinary Americans get a rare opportunity to weigh in on a life-and-death issue: Who gets access to scarce, life-saving treatments during a disaster?

The public has been invited to participate in a teleconference (PDF) in which advisers to the Centers for Disease Control and Prevention will discuss ethical guidance they have drawn up for rationing mechanical ventilators in a severe influenza pandemic.

The hourlong conference takes place at 3 p.m. EST and anyone can listen to the proceedings by calling (866) 919-3560 and entering passcode 4168828. According to the agenda, the committee is scheduled to vote on the guidance before it opens the meeting to public comments. The document will then go to the full advisory committee to the director of the CDC for approval.

The views of the advisory committee to the CDC director are not binding on states, which have ultimate authority over how to handle health emergencies. But the guidance is intended to serve as a "foundation for decision making" for health policymakers "at all levels -- federal, tribal, territorial, state, and local," according to the document.

Chances are, few people will phone in to join Monday's meeting. CDC officials have not advertised the session outside of a notice published late in the Federal Register. The draft guidance document (PDF) has not been widely released and was provided to ProPublica only after requests to several members of panel.

The document, dated Oct. 30, 2009, has some intriguing features. It parts company with several aspects of the guidelines drafted by states like New York and Florida, but it still envisions, at a time of extreme emergency, taking off of ventilators those patients who are not improving, to make way for others who may have better chances of surviving, even if family members do not agree. It says ethical guidance is particularly timely because shortages of mechanical ventilators could arise in the coming months if the H1N1 or "swine flu" virus becomes more widespread or severe.

According to a CDC spokesman, the guidelines were "developed independently" by an "independent group of experts on ethical principles" and are not CDC recommendations -- even though CDC employees made up two-thirds of the 18-member group that drafted the document.

Fewer than half of the group's members had substantial backgrounds in bioethics. Some helped write the allocation schemes analyzed in the document, putting them in the potentially uncomfortable position of assessing their own work.

The document, which makes few specific recommendations, offers what it terms an "ethical framework" for policymakers who are deciding who should receive ventilators:

New York, Utah, Florida and other states and groups of medical professionals have drafted pandemic triage guidelines that call for patients with certain pre-existing conditions (such as the elderly or those with advanced cancer, severe heart disease or severe neurological deficits) to be categorically excluded from access to ventilators or hospital admission in a severe pandemic. The panel suggested a different approach: All patients should be given a priority score calculated to reflect a variety of factors, such as the likelihood they would survive if given a ventilator, the number of years they are expected to live, or age. Guidelines should be based on evidence and revised on the basis of research, and no one should be summarily excluded.

The panel questioned whether it would be fair for policymakers to require certain people who have a comparatively lower but still reasonable chance of survival to give up ventilators to others with a better chance at survival, in an effort to increase the number of lives saved across a population. The document suggests that the goal of maximizing the "health of the public" in a disaster be weighed against giving all patients "a fair chance at survival."

The group advised against factoring an individual's perceived contributions to society into allocation decisions, writing: "In our morally pluralistic society, there has been widespread rejection of the idea that one individual is intrinsically more worthy of saving than another."

However, the committee accepted another controversial idea -- that mechanical ventilators could be disconnected from patients "whose prognosis has significantly worsened," regardless of their wishes, and provide those ventilators to "patients with a better prognosis." Patients, it said, "should be notified this will occur, given a chance to say good-byes and complete religious rituals, and provided compassionate palliative care."

Some doctors have questioned that last concept. The U.S. Supreme Court's acceptance of withdrawing life support hinges on the 14th Amendment's guarantees of a right to liberty. A patient or the patient's legal surrogate has a right to refuse treatment (or in rare cases a doctor can deem a treatment "futile" or not beneficial to the patient). Many of the states' triage plans for pandemics do not envision seeking consent before ventilators are withdrawn. Decisions would be made by clinicians using a clinical scoring system or exclusion criteria.

The draft document advises policymakers to include the public in "frank dialogue and genuine deliberation" about the various tradeoffs among the principles. "Most importantly," the report said, "the values and priorities of community members who will be impacted by decisions about allocation of scarce life-saving resources must be considered in the development of triage plans."

Thus far, the public has been little engaged. The ethics group spent two years drafting the document, and did not, as part of its deliberations, specifically reach out to the broader community.

Write to Sheri Fink at sheri.fink@propublica.org.

ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest.

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Preparing for a Pandemic, State Health Departments Struggle With Rationing Decisions

by Sheri Fink, ProPublica

New York state health officials recently laid out this wrenching scenario for a small group of medical professionals from New York-Presbyterian Hospital:

A 32-year-old man with cystic fibrosis is rushed to the hospital with appendicitis in the midst of a worsening pandemic caused by the H1N1 flu virus, which has mutated into a more deadly form. The man is awaiting a lung transplant and brought with him the mechanical ventilator that helps him breathe.

New York’s governor has declared a state of emergency and hospitals are following the state’s pandemic ventilator allocation plan -- actual guidelines drafted in 2007 that are now being revisited. The plan aims to direct ventilators to those with the best chances of survival in a severe, 1918-like flu pandemic where tens of thousands develop life-threatening pneumonia.

Because the man’s end-stage lung disease caused by his cystic fibrosis is among a list of medical conditions associated with high mortality, the guidelines would bar the man from using a ventilator in a hospital, even though he is, unlike many with his illness, stable, in good condition, and not close to death. If the hospital admits him, the guidelines call for the machine that keeps him alive to be given to someone else.

Would doctors and nurses follow such rules? Should they?

In recent years, officials in a host of states and localities, as well as the federal Veterans Health Administration, have been quietly addressing one of medicine’s most troubling questions: Who should get a chance to survive when the number of severely ill people far exceeds the resources needed to treat them all?

The draft plans vary. In some states, patients with Do Not Resuscitate orders, the elderly, those requiring dialysis, or those with severe neurological impairment would be refused ventilators, or admission to hospitals. Utah divides epidemics into phases. Initially, hospitals would apply triage rules to residents of mental institutions, nursing homes, prisons and facilities for the “handicapped.” If an epidemic worsened, the rules would apply to the general population.

Federal officials say the possibility that America’s already crowded intensive care units would be overwhelmed in the coming weeks by flu patients is small but they remain vigilant.

The triage plans have attracted little publicity. New York, for example, released its draft guidelines in 2007, offered a 45-day comment period, and has made no changes since. The Health Department made 90 pages of public comments public this week only after receiving a request under the state’s public records laws.

Mary Buckley-Davis, a respiratory therapist with 30 years experience, wrote to officials in 2007 that “there will be rioting in the streets” if hospitals begin disconnecting ventilators. “There won’t be enough public relations spin or appropriate media coverage in the world” to calm the family of a patient “terminally weaned” from a ventilator, she said.

State and federal officials defend formal rationing as the last in a series of steps that would be taken to stretch scarce resources and provide the best outcome for the public. They say it is better to plan for such decisions than leave them to besieged health workers battling a crisis.

“You change your perspective from thinking about the individual patient to thinking about the community of patients,” said Rear Adm. Ann Knebel of the Department of Health and Human Services.

But some health professionals question whether the draft guidelines are fair, effective, ethical, and even remotely feasible.

Most existing triage plans were designed for handling mass casualties. They sort injured victims into priority categories based on the urgency of their medical needs and their potential for survival given available resources. Much of the controversy over the state plans focuses on two additional features.

These are “exclusion criteria,” which bar certain categories of patients from standard hospital treatments in a severe health disaster, and “minimum qualifications for survival,” which limit the resources used for each patient. Once that limit is reached, patients who are not improving would be removed from essential treatment in favor of those with better chances.

A version of these concepts was outlined in a post-9/11 medical journal article that suggested ways to handle victims of a large-scale bioterrorist event. The author, Dr. Frederick Burkle Jr., said he based his ideas in part on his experiences as a triage officer in Vietnam and the gulf war and on a cold war-era British plan for coping with a nuclear strike. Dr. Burkle said that during the gulf war he once instructed surgeons to halt an operation and work on another patient who was more likely to survive. Surgeons later returned to the first patient.

Dr. Burkle’s ideas were key aspects of guidelines Ontario authorities drew up after SARS to plan for avian flu and other pandemics. This approach and one by a team of Minnesota doctors were modified by groups developing similar guidelines in the United States.

There were important distinctions. Dr. Burkle’s original paper did not anticipate withdrawing care from patients and stressed the need to reassess the level of supplies “sometimes on a daily or hourly basis” in a fluid effort to provide the best possible care.

Some states’ triage guidelines are rigid, with a single set of criteria intended to apply throughout the severe phase of a pandemic. That disturbs Dr. Burkle. “I have said to my wife, I think I developed a monster here,” he said.

Recent research highlights the problem of a one-size-fits-all approach to triage. Many state pandemic plans call for hospitals to remove patients from ventilators if they are not improving after two to five days. Studies show that people severely ill with H1N1 flu generally need a week to two weeks on ventilators to recover.

There is also controversy over what values and ethical principles should guide triage decisions, how to engage the public, and whether withdrawing life support in the hospital and withholding it at the hospital door are distinct.

Normally, removing viable patients from life support against their or their families’ will would be considered murder. The New York-Presbyterian Hospital employees who participated in the recent exercise said they would not comply unless given legal protection.

They also never figured out what to do with that hypothetical patient who had his own ventilator, said Dr. Kenneth Prager, a pulmonologist and ethicist. “The issue of removing patients from ventilators,” he said, “was so overwhelming that it precluded discussion of further case scenarios.”

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Children With Asthma More Vulnerable to H1N1 Virus

Nearly a dozen 7th graders with asthma were welcomed along with other classmates back to school yesterday by a special guest who had a message for them about staying healthy -- Kathleen Sebelius, 21st secretary of Health and Human Services (HHS).

Secretary Sebelius met with students and their parents at Thurgood Marshall Elementary, one of 16 schools in Philadelphia that partners with the Merck Childhood Asthma Network, Inc. (MCAN) program partners to help students better manage their asthma. She talked about the importance of education and creating healthy habits to avoid missing school.

"Nothing is more important than keeping our children healthy, in school and ready to learn as we start the new school year," says Dr. Floyd Malveaux, executive director of MCAN and former dean of the College of Medicine at Howard University. "We applaud Secretary Sebelius for recognizing that staying healthy can be a challenge for students with asthma -- a factor that is even further complicated with the possibility of being exposed to the H1N1 virus, which can increase the severity of asthma symptoms, leading to possible hospitalizations."

During the meeting, Sebelius highlighted the work of the Philadelphia MCAN project as a model for inner-city childhood asthma management. Launched in 2005, the Philadelphia MCAN project has improved asthma outcomes for children and reduced school absenteeism by using a community-based approach that integrates families, community agencies, schools and health care providers to implement scientifically proven asthma interventions.

The Philadelphia program brings hope into communities that shoulder a disproportionate share of the childhood asthma burden. Screening conducted with the Philadelphia MCAN project in partnership with The School District of Philadelphia found that one out of four students in the West, Southwest, Olney, Logan and Germantown communities - target communities for the program -- have been diagnosed with asthma or have been admitted to the hospital for wheezing, compared to one out of ten nationwide.

The Philadelphia program provides children with asthma and their families access to three key services: Community Asthma Prevention Program (CAPP) classes that educate parents, other caretakers and children with asthma; CAPP home visits where community health workers help families eliminate or control allergens and irritants within the home; and Health Promotion Council (HPC) Link Line services that connect families to asthma care coordinators.

"The unique structure of our program allows us to bring multiple stakeholders to the table to create a successful team that can get children to care and services for better long-term and immediate asthma management," says Dr. Michael Rosenthal of Thomas Jefferson University and co-lead investigator of the Philadelphia MCAN program. "By collaborating with specific schools to identify children that have asthma, the Philadelphia MCAN project has armed school nurses with essential information to assist students who are at higher risk for complications with H1N1 and seasonal flu virus, allowing them to be better prepared to manage these children at school."

Nationally, MCAN, a non-profit organization funded by the Merck Company Foundation, provides funding to four other local programs that target low-income, urban populations with high rates of pediatric asthma in Chicago, Los Angeles, New York and Puerto Rico. The goal is to evaluate the effectiveness of these programs and use the findings to develop model programs that can be replicated and tailored in communities across the country.

"The Philadelphia MCAN program has shown that we can help children manage their asthma and that means improved quality of life, significantly fewer trips to the ER or stays in the hospital, and best of all, more days in school," says Dr. Tyra Bryant-Stephens from The Children's Hospital of Philadelphia and co-lead investigator of the Philadelphia MCAN project. "Empowering caregivers and children with this knowledge has helped to greatly decrease the school days missed by children in Philadelphia, a segment of the nearly 13 million schools days missed each year by the millions of children nationwide that have been diagnosed with asthma."

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Researcher: 1918 Spanish Flu Virus Can Infect Swine, Resulted In Current Lineage of H1N1 Swine Flu Viruses

In 1918 a human influenza virus known as the Spanish flu spread through the central United States while a swine respiratory disease occurred concurrently. A Kansas State University researcher has found that the virus causing the pandemic was able to infect and replicate in pigs, but did not kill them, unlike in other mammalian hosts like monkeys, mice and ferrets where the infection has been lethal.

Juergen Richt, Regents Distinguished Professor of Diagnostic Medicine and Pathobiology at K-State's College of Veterinary Medicine, studied the 1918 Spanish flu pandemic with colleagues from the Canadian Food Inspection Agency, U.S. Department of Agriculture and Mount Sinai School of Medicine.

Their research supports the hypothesis that the 1918 pandemic influenza virus and the virus causing the swine flu were the same. Richt said the virus was able to infect and replicate in swine and cause mild respiratory disease. The 1918 virus spread through the pig population, adapted to the swine and resulted in the current lineage of the H1N1 swine influenza viruses. The researchers' study is published in the May 2009 Journal of Virology.

"This study emphasizes that an influenza virus, which is known to induce a lethal infection in ferrets and macaques, is not highly virulent in pigs, indicating a potential resistance of swine to highly virulent influenza viruses," Richt says. "It also suggests that pigs could have played a role in maintaining and spreading the 1918 human pandemic influenza virus."

Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among the animals and can be transmitted to humans. It is a typical zoonotic agent. While swine flu was first recognized as a disease in 1918, there also were reports of the influenza occurring in the Midwest in 1930.

For the study, the researchers used the 1918 pandemic virus and a 1930 H1N1 influenza virus for experimental infections in swine. The 1930 virus was chosen as a virus because it is thought to be a descendent of the 1918 virus, Richt said.
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The researchers did not find a significant difference in effects from the 1918 and 1930 viruses in infected pigs. This was surprising, since the 1918 virus killed more than 20 million people and was lethal to ferrets, mice and macaques. Another surprising finding from the study was the rapid antibody response in the animals infected with the 1918 virus, which is not typically reported for the swine influenza virus.

Richt says he plans to conduct a follow-up project that will study what makes a swine flu virus a pandemic flu virus.

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