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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 The draft guidance document (PDF) has not been widely released and was provided to ProPublica only after requests to several members of panel.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.

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In Chicago’s Nursing Homes, a Psychiatrist Delivers High-Risk Meds, Cut-Rate Care

by Christina Jewett, ProPublica, and Sam Roe, Chicago Tribune

Inside Chicago's Maxwell Manor nursing home, Dr. Michael Reinstein's patients suffered from side effects so severe that they trembled, hallucinated or lost control of their bladders.

Staffers told state investigators that so many patients were clamoring to complain to Reinstein about their medications that a security guard was assigned to accompany him on his visits. In addition, staffers said Reinstein had induced patients to take powerful antipsychotic drugs with the promise of passes to leave the home.

Though state officials shut that facility in 2000 for inadequate care and wretched conditions, Reinstein, the home's lead psychiatrist, continued to practice. Today he is one of the most prolific providers of psychiatric care in Chicago-area nursing homes and mental health facilities, even as he is trailed by lawsuits and complaints like the ones at Maxwell Manor.

Neither state nor federal officials appear to have ever assembled a complete picture of Reinstein’s thriving practice, built in part within Illinois’ poorly regulated system of nursing homes serving the mentally ill. But an investigation by ProPublica and the Tribune found that Reinstein has compiled a worrisome record, providing assembly-line care with a highly risky drug.

Searching publicly available documents, reporters discovered that Reinstein, 66, has been accused of overmedicating his mentally ill patients. His unusually heavy reliance on the drug clozapine — a potent psychotropic medication that carries five "black box" warnings — has been linked to at least three deaths.

In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show.

Records also show he is getting reimbursement for seeing an improbably large number of patients. Documents filled out by Reinstein suggest that if each of his patient visits lasts 10 minutes, he would have to work 21 hours a day, seven days a week. Research has found that the typical U.S. psychiatrist sees about 35 patients per week; Reinstein sees 60 each day, he wrote in an audit report in 2007.

Illinois provides some powerful incentives for cut-rate, high-volume care in nursing homes for the mentally ill, where Reinstein sees most of his patients.

The state Medicaid program pays psychiatrists as little as $22 per patient for some services, a rate drastically less than customary fees. State lawmakers recently failed to act on a bill that would have given psychiatrists the first Medicaid fee increase in years.

Working from a strip-mall office in Uptown, Reinstein says he is psychiatric medical director at 13 nursing facilities, seeing patients with chronic mental illness whom few doctors will accept.

Those include people with schizophrenia, who make up the bulk of his practice. His supporters say they admire the hard working doctor, who makes daily rounds in a car with 140,000 miles on the odometer. And Reinstein maintains that clozapine was not to blame for the patient deaths.

In written statements to ProPublica and the Tribune, Reinstein said he does work long hours seven days a week, as do his four partners, who separately also prescribe clozapine. State records overstate his workload, he said, because of a computer system that forces him to submit claims several times. He said he is trying to recruit more doctors to his practice, but it has been difficult because of low pay, high malpractice insurance rates and a perception that the work is dangerous.

He also strongly defended his reliance on clozapine, saying the medication is underprescribed and is the most effective in its class for schizophrenic patients. That view is supported by a prominent study that found clozapine helped patients more than similar, newer drugs. Clozapine can control psychotic episodes, reduce suicide risk and help patients live independently outside of institutions, Reinstein said.

"The most gratifying part of my day," he wrote, "(is) when patients reach this level and come to the office!!!"

See related story: One Psychiatrist, Many Prescriptions

Autopsy and court records show that three patients under Reinstein’s care died of clozapine intoxication. Alvin Essary died at age 50 inside at the Somerset Place nursing home on the North Side in 1999. Medical records show that when he died his blood contained five times the toxic level of clozapine.

The plaintiff’s expert in his family’s medical malpractice lawsuit contended that Reinstein was grossly negligent to give multiple medications to a man with only one kidney. Reinstein settled the claims against him for $85,000, but Essary’s sister, Shirley Palmer, said she can’t believe he is still practicing.

"There’s nothing that’s been done to this doctor who’s caused all these problems," Palmer said. "It makes me mad that this keeps going on."

Reinstein has a far different view of his career.

"I am grateful for the opportunity to be of service to the patients I treat and have treated for over 37 years," he wrote. "I take pride in the many people I have been able to help and feel badly about those patients who have not seen the benefits of treatment."

Potent pill, multiple warnings

Use of any medication carries risks, but clozapine stands out. It ranks just behind the more widely used painkiller oxycodone as the medication suspected in the most patient deaths, according to a study that examined reports to the Food and Drug Administration.

The "black box" warnings -- the FDA's strongest -- on clozapine’s label detail serious potential side effects, from enlargement of the heart to rapid drops in blood pressure to increased seizure risk. Doctors also are required to take regular blood samples to ensure patients’ immune systems aren’t shutting down.

The FDA approved the drug for only a sliver of the population: the actively suicidal or the quarter of schizophrenic patients who do not improve on medications with lesser side effects. Yet Reinstein last year said under oath that his practice once had more than 300 patients among 415 in one Chicago nursing home on clozapine.

Reinstein said he completes the FDA-mandated blood tests for patients on clozapine but calls them "excessive and severe." Although other psychiatrists said it is crucial to discuss the numerous risks of clozapine with patients, Reinstein said he gives them the product insert — and hopes they read it.

His use of clozapine is at the heart of separate lawsuits filed after the deaths of two patients he treated: Odell Spruell and Wendy Cureton.

Reinstein took over Spruell’s care in 2007 when the 54-year-old was transferred from a nursing home to a psychiatric ward after hitting other patients and staff, records show. A former steel mill worker, Spruell had been stable on a low dose of clozapine for about two years. Reinstein doubled his dose and returned him to the nursing home.

Spruell lived another two weeks under the care of a Reinstein partner. During that time, he grew increasingly lethargic and suffered other symptoms associated with overmedication. His hands shook, he drooled and he began sleeping all the time, said his sister, Irma Spruell.

"He was too weak to get up," she said. "He tried to talk, but he couldn’t."

Staff members at Spruell’s nursing home also noticed his lethargy. In response, they put him into physical therapy. Five days later, Spruell fell unconscious and could not be revived. An autopsy showed that said he died of clozapine intoxication. A lawsuit is pending in Cook County Circuit Court.

Reinstein declined to comment, citing a patient privacy law.

Cureton, 27, died four years before Spruell. In 2003, she was moved from a nursing home to the psychiatric ward at Kindred Hospital North on Chicago’s North Side.

She had grown increasingly aggressive after two of her family members died in a house fire. Reinstein, her supervising psychiatrist, and two partners repeatedly boosted Cureton’s clozapine dose — two times faster than the recommended pace, according to her medical records and guidelines published by the drug’s maker. Medical staff noted that she remained hostile and unpredictable, at times pounding on the wall or laughing at it.

On the 10th day in the psychiatric ward, Cureton had trouble breathing and was taken to the emergency room. The drug’s label explicitly warns of that adverse reaction and says doctors should not mix clozapine and certain sedatives, as the team under Reinstein’s supervision had done, medical records show.

Reinstein saw her after she returned from the emergency room and boosted her dose of another antipsychotic, her medical records show. Within days, Cureton collapsed next to her bed and could not be revived.

A medical malpractice suit is pending in Cook County Circuit Court. In a pretrial deposition, Reinstein defended boosting the dose of the clozapine, saying Cureton was obese and had tolerated a high amount in the past. He also said the autopsy finding that she died of clozapine intoxication was unreliable because research shows that clozapine levels spike after death.

The physician who performed the autopsy did not dispute that. But he said Cureton’s sudden collapse before death and the condition of her heart and lungs afterward led him to conclude that she died of clozapine intoxication.

‘He wouldn’t talk to them’

Reinstein has his supporters in the medical community. Nurse Bernadette Wright lavished him with praise, saying, "The man is a genius."

"He knows his patients," said Wright, head of nursing at Sacred Heart Home in Chicago, where Reinstein is psychiatric medical director. "He knows them by name and by face. When you tell him about a patient, he knows their history."

Reinstein "would never" give risky drugs without properly monitoring patients, she said.
But one nurse who worked with Reinstein said she worried that he was too busy to give his patients the time they needed.

Former Riveredge Hospital nurse Eileen "Cookie" Kempe said in an interview that when Reinstein visited, he went into a room and furiously wrote on stacks of medical records as his patients lined up in the hall. "He wouldn’t talk to them," said Kempe, who worked with Reinstein for a year until 2004. "I never saw him go in a patient room, ever. They got no therapeutic interaction with a doctor."

Riveredge is where Reinstein treated a 27-year-old pregnant patient, Tameka Williams, in 2007 after she had an acute schizophrenic episode. She never signed a required form agreeing to take clozapine; nor was her immediate family consulted, according to records and interviews.

Even though it has not been proved safe for use during pregnancy, Reinstein prescribed clozapine, Williams' medical records show. At some point, Williams had developed a blood clot -- a condition particularly threatening for a patient on clozapine. She died days after being admitted when the clot lodged in her heart. A lawsuit against Reinstein is pending in Cook County Circuit Court.

State regulators inspecting Westwood Manor, a Chicago nursing home, noted in 2003 that several of Reinstein’s patients were not properly monitored. Some showed apparent clozapine side effects. One trembled when he walked. Another kept a cigarette butt in her mouth to prevent her tongue from jutting out.

In a written response to the inspection, Reinstein cited a "lack of clinical sophistication on the part of the evaluator(s) … on medication effectiveness." He also said in a written response to reporters that tongue jutting and trembling "are not usual" side effects of clozapine.

Reinstein's troubles were perhaps most dramatic at Maxwell Manor, a South Side nursing home. The Illinois State Police and the U.S. Postal Service began investigating Reinstein in 2000 amid accusations of billing fraud, according to documents obtained through public records requests.

Included in those documents is the account of a Maxwell Manor psychiatric supervisor who said Reinstein heavily promoted Clozaril, the original brand name for clozapine. Deborah Grier told state police investigators that Reinstein had handed out glossy fliers to staff and prescribed the drug to nearly all of his patients.

Grier, who has since died, said Reinstein persuaded some patients to take the drug by offering passes to leave the home.

She said patients often complained of hallucinations from the drug and that she "had many conversations with Reinstein about how many patients … had bad reactions." But she said he "very seldom" reduced doses or switched drugs, investigators wrote.

Another Maxwell Manor worker, Engoyama Fela, told investigators that Reinstein "would not spend more than one minute" with a patient during his rounds, according to a summary of the interview. "Many patients became agitated and rebellious because they knew they needed care and they wanted to talk to Reinstein but were not allowed to," he said.

Fela said Maxwell Manor security staffers were assigned to guard Reinstein when he came to update their medical records.

Reinstein, in a written response to reporters, denied the workers’ allegations, saying he spends an appropriate amount of time treating patients in consultation with other medical staff. He agreed that security was present at Maxwell Manor but not specifically to protect him. "This facility had many violent and disruptive patients," he said.

Several years after regulators shut the home, the U.S. Justice Department, in a separate civil fraud case, alleged that residents had been routinely abused and medicated as punishment.

Reinstein, who said he saw a majority of the patients at the facility, was not a defendant in the federal civil case. Criminal prosecutors investigating possible billing fraud by Reinstein did not file charges against him.

Barry Miller, the prosecutor overseeing the criminal inquiry, declined to comment. Case records say the matter was referred to Medicare to recover any overpayments. Agency officials declined to comment. Reinstein said he was not sanctioned by Medicare and did not have to reimburse the agency.

Retired state investigator Ray Lewis was unhappy to see the criminal case closed. In a recent interview, he said that if there were one Medicaid fraud case he could revisit, Reinstein’s would be it. "I’d investigate it for free," Lewis said.

The agency responsible for investigating physician conduct, the Illinois Department of Financial and Professional Regulation, does not reveal to the public the number of complaints filed against doctors, only findings where there was formal disciplinary action. In 1997, the agency cited Reinstein for improperly admitting a patient for psychiatric care and ordered him to complete 50 hours of education.

Since then, the agency has received at least one other complaint about Reinstein.

In 2003, Chicago psychiatrist Dr. Mark Amdur, of the Thresholds mental health organization, became so concerned about Reinstein’s work at area nursing homes that he asked his staff to find out how many patients came under Reinstein’s care. The number — 2,300 — surprised him.

"I believe that the apparent concentration of care under a single practitioner should be a matter of concern ...," Amdur wrote state regulators.

When asked what happened to his complaint, the Illinois Department of Public Health said it could not be found, and the professional regulation agency could produce no evidence of follow-up.

Amdur said he never got a response. "There ought to be some outside review for the benefit of the people residing in these nursing homes," he said.

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Pennsylvania Tells Drilling Company to Clean Up Its Act

by Sabrina Shankman, ProPublica

After a year of chemical spills, water well contamination and an explosion caused by leaking underground methane, Cabot Oil and Gas Corp. has been fined $120,000 and ordered to abide by a set of stricter-than-usual probationary regulations if it wants to continue its vast natural gas drilling operation in Pennsylvania.

The judgment is the latest chapter in a saga of drilling controversy and environmental contamination as a result of drilling for natural gas in northeastern Pennsylvania that we’ve been following since January, and is part of our ongoing investigation into the environmental consequences of gas drilling across the country.

The charges and conditions against Cabot were outlined by the Pennsylvania Department of Environmental Protection in a 23-page document that lists each of Cabot’s offenses – from failure to properly cement wells to failure to maintain and submit proper records – and asks the company to acknowledge and address the findings. The fine is the largest issued by the Pennsylvania agency to a gas company.

Cabot signed the order Wednesday agreeing to the state’s conditions, but seemed to stop short of taking full responsibility. “The department made several findings, and we agreed with the basic facts as they were laid out,” said a Cabot spokesman, Ken Komoroski. “But Cabot did not agree to the legal conclusions of violations of laws and regulations.”

The DEP began investigating Cabot early this year, after residents in Dimock, Pa., started reporting methane bubbling out of their faucets – a sign that natural gas had contaminated their water supplies. Investigators found that some of Cabot’s well casings, which seal well pipes from water supplies, were faulty and had allowed natural gas to migrate into the groundwater.

The groundwater incidents were the first of several spills and accidents that followed. In at least two cases the company spilled diesel or drilling fluids that reached water supplies. And in September, the DEP ordered Cabot to stop its hydraulic fracturing operations in Susquehanna County after it allowed three hydraulic fracturing fluid spills in nine days. The ban was lifted on Oct. 16, after the company revised its pollution prevention and control plan.

Now the company has until March 31 to comply with parts of the DEP’s order and submit a plan outlining how it will permanently replace the water supplies for more than a dozen affected homes near the town of Dimock.

The most important requirements have to do with well construction. Cabot will have to submit well casing and cementing plans to the DEP, which will have to approve the well before Cabot can proceed with drilling or any hydraulic fracturing. The company will also have to submit a plan that specifically lays out how it will prove the integrity of the casing and cementing on existing wells and fix any that are defective. If the defective casing isn’t fixed by the March deadline, Cabot will be ordered to plug its defective wells.

“They’ve got to go back and fix all of those wells,” said DEP spokeswoman Teresa Candori.
Finally, the company will be required to tell the DEP who has contacted the company with concerns about the quantity or quality of their water supplies.

“It does add some additional requirements beyond the regulations but these are measures and procedures that Cabot agrees are appropriate for the area,” Cabot spokesman Komoroski said.
Cabot has been drilling in the Marcellus Shale of Pennsylvania since 2006. It drilled one well in 2006, and one in 2007, before ramping up in 2008 and drilling 20. The company will drill between 40 and 60 wells in 2009, and has plans to drill between 50 and 70 more in 2010.

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Public Gets More Time to Comment on New York’s Gas Drilling Plans

by Sabrina Shankman, ProPublica

Responding to calls from politicians, environmentalists and concerned residents, the New York State Department of Environmental Conservation announced Wednesday that it has extended the public comment period for an environmental review of natural gas drilling in the Marcellus Shale.

The comment period, which began Sept. 30 with the release of the draft Supplemental Generic Environmental Impact Statement, now extends through Dec. 31. It was previously slated to end Nov. 30. Since the release of the technical, 800-plus page document, there have been complaints that the original 60-day comment period was insufficient for people to read and understand its findings.

"This is the biggest environmental issue of the decade in New York," Manhattan Borough President Scott Stringer said in a statement. "It’s good to see that the public’s demand for more time has been heard."

The DEC has also moved up the start time for the second public hearing on the environmental review, which will be held Nov. 10 at Stuyvesant High School in New York City. Doors for the hearing will now open at 5:30 p.m. for individual questions and speaker sign-up. The DEC staff will also be on hand to answer questions about the draft. The public comment period will begin at 6:30 p.m. (More info on the public hearings here.)

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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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