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 The draft guidance document (PDF) has not been widely released and was provided to ProPublica only after requests to several members of panel.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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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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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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1918 Flu Antibodies Resurrected From Elderly Survivors

Ninety years after the sweeping destruction of the 1918 flu pandemic, researchers at Monroe Carell Jr. Children's Hospital at Vanderbilt University have recovered antibodies to the virus –- from elderly survivors of the original outbreak.

In addition to revealing the surprisingly long-lasting immunity to such viruses, these antibodies could be effective treatments to have on hand if another virus similar to the 1918 flu breaks out in the future.

The study, led by Dr. James Crowe Jr., M.D., professor of pediatrics and director of the Vanderbilt Program in Vaccine Sciences, Christopher Basler, at the Mount Sinai School of Medicine, and Dr. Eric Altschuler, M.D., at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School, is published online in the journal Nature.

The influenza pandemic of 1918 killed nearly 50 million people worldwide, many of whom were young, healthy adults. With fears of another looming flu pandemic stoked by the emergence of "bird flu" in Asia, researchers have wanted to study the 1918 virus and the immune response to it.

In 2005, researchers from Mount Sinai and the Armed Forces Institute of Pathology in Washington, D.C., resurrected the 1918 virus from the bodies of people killed in the outbreak. The bodies, and the virus, had been preserved in the permanently frozen soil of Alaska.

When the investigators approached Crowe, whose lab had developed methods of making antibodies, to try to make antibodies to the 1918 flu, he was skeptical, but agreed to try.

The researchers collected blood samples from 32 survivors age 91-101 years and found that all reacted to the 1918 virus, suggesting that they still possessed antibodies to the virus.

Crowe's team was then able to isolate exceedingly rare B cells – the immune cells that produce antibodies – from eight of those samples and grow them in culture. Seven of those samples produced antibodies to a 1918 virus protein, suggesting that their immune systems were waiting on standby for a long-awaited second outbreak.

"The B cells have been waiting for at least 60 years – if not 90 years – for that flu to come around again," Crowe says. "That's amazing…because it's the longest memory anyone's ever demonstrated."

Crowe's team then fused cells showing the highest levels of activity against the virus with "immortal" cells to create a cell line that secretes monoclonal (or identical) antibodies to the 1918 flu. The antibodies reacted strongly to the 1918 virus and cross-reacted with proteins from the related 1930 swine flu but not to more modern flu strains.

To test if these antibodies still work against 1918 flu in a living animal, Crowe's collaborators at the Centers for Disease Control and Prevention infected mice with the 1918 flu and then administered the antibodies at varying doses. Mice receiving the lowest dose of 1918 antibody – and those receiving a non-reactive "control" antibody – died. All mice given the highest doses of 1918 antibodies survived.

Although aging typically causes immunity to weaken, "these are some of the most potent antibodies ever isolated against a virus," Crowe says. "They're the best antibodies I've ever seen."

The findings suggest that B cells responding to a viral infection – and the antibody-based immunity that results – may last a lifetime, even nine or more decades after exposure.

These antibodies could be used as potential treatments for future outbreaks of flu strains similar to the 1918 virus. And the technology could be used to develop antibodies against other viruses, like HIV.

Most importantly, says Crowe, "the lessons we are learning about the 1918 flu tell us a lot about what may happen during a future pandemic."

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Lessons From Turkey's Bird Flu Outbreak

Rapid responses by Turkey's health authorities and key health personnel were critical in bringing the 2006 bird flu outbreak under control, according to research published in the online open access journal, BMC Public Health. Those involved cite poverty and families sharing their homes with poultry as factors behind the virus' transfer to humans.

During early 2006, 12 avian influenza cases were confirmed in Turkey, of which eight cases occurred in the Dogubeyazit-Van region. Ozlem Sarikaya of the University of Marmara, Istanbul and Tugrul Erbaydar of the University of Yuzuncu Yil, Van, conducted in-depth interviews with senior health professionals to evaluate attempts to control the outbreak.

The authors found that, although a crisis committee was created quickly, healthcare workers felt anxious and ill-prepared due to a lack of clarity about their responsibilities in emergency disease plans, and delays in receiving protective clothing. The researchers also found that the coordination between the human and animal health services was not sufficient. Despite these difficulties, open communication between the government and the public, as well as the health authorities' and health workers' efforts, helped control the epidemic. Poultry rearing practices, coupled with poverty and poor access to healthcare, were the primary risk factors for infection.

"Lessons learned from this outbreak should provide an opportunity for integrating the
preparation plans of the health and agricultural organizations," say Sarikaya and Erbaydar, "and for revising the surveillance system and enhancing the role of the primary health care services in controlling epidemic disease." They add that informed response strategies will play an invaluable role in the control of a future avian influenza pandemic.

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DOD Could Improve Pandemic Flu Preparedness, Audit Finds

An influenza pandemic could impair the military’s readiness, jeopardize ongoing military operations abroad, and threaten the day-to-day functioning of the Department of Defense (DOD) due to a large percentage of sick or absent personnel, according to a recent federal report.

Each of DOD’s nine combatant commands (COCOMs) has established or intends to establish a working group to prepare for an influenza pandemic, the Government Accountability Office (GAO) finds in a recent report. GAO is the nonpartisan investigative arm of Congress.

Additionally, eight of the nine COCOMs have developed or are developing a pandemic influenza plan. Half of the COCOMs have conducted exercises to test their pandemic influenza plans and several are taking steps to address lessons learned. Five of the nine COCOMs have started to use various media, training programs, and outreach events to inform their personnel about pandemic influenza. Each of the geographic COCOMs has worked or plans to work with nations in its area of responsibility to raise awareness about and assess capabilities for responding to avian and pandemic influenza, according to the GAO study.

GAO recommends that DOD take steps to clarify the COCOMs’ roles and responsibilities for pandemic influenza-related efforts, identify the sources and types of resources needed for the COCOMs to accomplish these efforts, and develop options to mitigate the effects of factors that are outside of their control. DOD concurred with each of these recommendations, GAO says.

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Bird Flu Survivors' Antibodies Effective at Neutralizing H5N1 Strain

Adults who have recovered from the potentially deadly H5N1 strain of avian influenza may hold the key to future treatments for the virus, according to an international team of researchers. In a study published in the open access journal PLoS Medicine, the researchers have shown how specific antibodies taken from avian flu survivors in Vietnam can be reproduced in the laboratory and prove effective at neutralising the virus in culture vitro and in mice.

The H5N1 influenza virus has caused disease and death in millions of poultry across the globe and occasionally has been transmitted to humans, often fatally. By mid-May 2007, according to the World Health Organization, there had been 306 known cases in humans, 185 of them fatal.

Now, doctors based at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam, the Institute for Research in Biomedicine in Bellinzona, Switzerland and the National Institute of Allergy and Infectious Diseases in Bethesda, US, have shown that monoclonal antibodies generated from blood of human survivors of the H5N1 virus are effective at both preventing infection in mice and neutralising the virus in those already infected. The research had been fast-tracked for funding by the UK's Wellcome Trust and is also supported by grants from the National Institutes of Health in the US and the Swiss National Science Foundation.

The researchers found that the antibodies provided significant immunity to mice that were subsequently infected with the Vietnam strain of H5N1. This reduced significantly the amount of virus found in the lungs and almost completely prevented the virus reaching the brain or spleen. In those people in Vietnam who died from the H5N1 strain, the virus was found to have spread from the lungs; this was not the case in those who survived.

"We have shown that this technique can work to prevent and neutralize infection by the H5N1 'bird flu' virus in mice," says Dr Cameron Simmons, a Wellcome Trust researcher at the Oxford University Clinical Research Unit, Vietnam. "We are optimistic that these antibodies, if delivered at the right time and at the right amount, could also provide a clinical benefit to humans with H5N1 infections."

"In particular, we found that it was possible to administer the treatment up to 72 hours after infection. This is particularly important as people who have become infected with the virus do not tend to report to their local healthcare facilities until several days after the onset of illness."
The antibodies were discovered in the laboratory of Professor Antonio Lanzavecchia at the Institute for Research in Biomedicine in Switzerland. The researchers used a new technique that allows them to rapidly reproduce human monoclonal antibodies starting from a small sample of blood.

"We can't say for certain that a pandemic influenza virus will resemble the H5N1 strain that we have been studying or that the monoclonal antibodies generated using our technique will be able to tackle such a virus," says Lanzavecchia. "Nevertheless, we are encouraged by the broad neutralizing activity of these antibodies in the lab and the moderate doses required."

Using administered antibodies has a historical precedent. During the 1918 Spanish H1N1 influenza pandemic, there were multiple reports of physicians administering blood taken from survivors to patients infected with the disease. A recent review suggested that this treatment was associated with a halving in mortality. However, directly administering blood carries a risk of infection with other blood diseases, such as Hepatitis C and HIV.


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Faster, Better Emergency Response Through Satellite

When emergency teams are well informed and governments can coordinate their efforts, lives and property can be saved. The Health Early Warning System, a project supported by the European Space Agency (ESA), is intended to bring this benefit to Europe. Extreme natural phenomena like tsunamis, earthquakes and hurricanes have featured prominently in the news. So, too, has the rapid spread of new diseases such as SARS and avian flu. By identifying and mapping occurrences of these problems sooner, agencies can relieve suffering more quickly and contain a situation more efficiently. That is why ESA is supporting the Health Early Warning System (HEWS), which will improve the performance of emergency service end-users.

HEWS offers these users a wider, real-time perspective of events and how to manage them. It integrates knowledge of a particular threat or disease and brings it to remote areas, even if they are in an extreme state of disorder. It helps with logistical support and reduces the need to carry large amounts of heavy equipment to trouble spots.

A pan-European solution HEWS works by setting up a communication network via satellite to survey and monitor risk indicators. It allows communication between teams in the field and with command centres. Data from many locations can be collected, stored and processed. It can then be quickly analysed and distributed to the users who need it the most. HEWS is an open platform, built using a modular approach, so the widest variety of users can implement it. What will make HEWS critical to disaster relief agencies is that it is satellite based. Disasters may disrupt or even destroy local infrastructure – but satellites are immune to their effects.

Two scenarios

The system will be tested in two different exercise scenarios, one African and one European. In the first, a suspected case of an infectious disease is reported. Field teams will be deployed by the local Ministry of Health, international organisations and NGOs. The scenario will require them to assess the current situation and deploy a mobile laboratory. Based on field reports, a practice emergency will be declared. HEWS will provide real-time reporting from the various locations and provide insight into how the epidemic is developing. A response will then be organised and feedback provided to mobile teams on road access, water, food, drugs, and medical disposables.

The second scenario simulates a terrorist attack in the center of a European capital. The resulting confusion leads to traffic jams and saturation of the mobile telephone network. The work of the many civil protection and health operators, who are all entering the scene at the same time, is hindered by a lack of coordination and field information, particularly on decontamination measures and treatment protocols. HEWS will give civil protection authorities the ability to supply this information and coordinate the field teams correctly.

HEWS is the work of a consortium of three companies, Instituto Nacional de Saúde and Tekever S.A., both from Portugal, and Ridgeback s.a.s. from Italy. The project is co-financed by ESA as part of the Health and Telemedicine via Satellite Program.

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Researchers Develop Pandemic Flu Prediction System

The 2003 epidemic of Highly Pathogenic Avian Influenza (HPAI) in the Netherlands is the only recent epidemic of HPAI in the developed world. Gert-Jan Boender and colleagues have examined the data from this outbreak and produced a model which can predict the probability of infection from one farm to another; the "transmission kernel." They also identify high-risk areas in the Netherlands and analyze various control strategies, concluding that in these regions an epidemic can only be brought to an end by massive culling of susceptible farms.

For avian influenza, the analyses show that there are two poultry-dense areas in The Netherlands where epidemic spread is possible, one in the central region and one in the south, close to the German and Belgian border. The authors suggest local control measures are unlikely to be able to halt an unfolding epidemic in these areas.

The paper, published in the journal PLoS Computational Biology, arrives at these conclusions through a computational (or mathematical) modeling method, an approach which has already proved its worth in the analysis of infectious diseases such as the 2001 foot-and-mouth outbreak in the UK. The method can estimate the key parameters which determine the spread of highly transmissible animal diseases between farms. These risk maps identify geographic areas in which a given intervention strategy fails to control the spread of the disease between farms. "The risk map concept is an instrument suitable for analyses of epidemic control options both during crisis and in peacetime" says Boender.


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Rand Panel Makes Recommendations To Respond To Pandemic

A panel of experts convened by the RAND Corporation has recommended actions that communities around the United States should take to be better prepared to deal with bioterrorist attacks, pandemic flu outbreak and other large-scale public health emergencies.

The recommendations announced by RAND, a nonprofit research organization, consist of 16 actions listed under three broad categories. They call for communities to:

• Have a coordinated rapid-response capability. This should include well-defined roles and responsibilities for officials and the public; a clear command structure; strong public communications; the ability to provide emergency health care to large numbers of people; and the ability to monitor the spread of a public health emergency.
• Develop and maintain adequate numbers of operations-ready public health workers and volunteers.
• Engage in a continuous process of testing, improvement and maintenance of systems for tracking and reporting information on readiness to decision-makers and the public.
  

“The panel's work provides a clear, new definition of public health emergency preparedness and describes the critical ingredients that constitute a prepared community,” says Christopher Nelson, lead author of the report that was produced by RAND Health's Center for Domestic and International Health Security. “This will not only help communities and government agencies figure out where the gaps are, but also where future investments should be made.”

The panel defined public health emergency preparedness as: “The capability of the public health and health care systems, communities and individuals to prevent, protect against, quickly respond to and recover from health emergencies, particularly those whose scale, timing or unpredictability threatens to overwhelm routine capabilities. Preparedness involves a coordinated and continuous process of planning and implementation that relies on measuring performance and taking corrective action."

The proposed RAND definition emphasizes that responsibility for public health preparedness lies not only with governmental agencies but also with active, engaged and mobilized community residents, businesses, and non-governmental organizations.

The definition also states that preparedness should build upon day-to-day public health systems and be regularly tested.

“If you ask public health and government officials, ‘What is a public health emergency?' no two people will give you the same answer,” says Nicole Lurie, MD, co-director of the RAND Center for Domestic and International Health Security. “Without a clear definition of what a public health emergency is and how to prepare for one, communities and states cannot assess whether or not they are prepared.”

“It's not enough to just have a plan for public health emergencies,” Nelson says. “Communities need to have tested all the elements to make sure these plans will work in a time of crisis.”

"The conceptualization and definition of public health preparedness proposed in this editorial is concise, clear and to the point," says Paul Jarris, MD, executive director of the Association of State and Territorial Health Officials. "The authors provide a framework to guide the development of performance metrics and continuous improvement of our nation's public health readiness."

The report from the RAND Health panel, chaired by former Virginia governor and 2008 Republican presidential candidate James Gilmore III, appears online as an editorial in the Public Health Preparedness supplement to the April issue of the American Journal of Public Health. It is titled “Conceptualizing and Defining Public Health Emergency Preparedness.” The report was funded by the U.S. Department of Health and Human Services.

Since the terrorist attacks of Sept. 11, 2001, the U.S. government has invested more than $5 billion to increase the country's ability to prepare for and respond to public health emergencies.

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USAID Bolsters International Avian Influenza Response

The U.S. government through the U.S. Agency for International Development (USAID) announced a three-year contract to bolster international capacity for avian and pandemic influenza response. Stamping Out Pandemic and Avian Influenza (STOP AI), awarded to Development Alternatives, Inc., is designed to play a critical role in U.S. efforts to limit the impact of avianinfluenza and to minimize its potential to spread globally. The contract is worth up to $35.8 million.

Highly pathogenic H5N1 avian influenza has to date been detected in 55 countries, resulting in the death or destruction of over 220 million birds, and the deaths of 170 people, according to the World Organization forAnimal Health (OIE) and UN health officials. Its potential to mutate into a form easily transmitted to humans has sparked concerns of a potential human influenza pandemic. STOP AI aims to increase global capacity to contain H5N1 avian influenza in animals, therefore minimizing its spread from animals to humans and the opportunity for it to develop into a pandemic strain.

Ambassador John Lange, the U.S. Special Representative, Avian and Pandemic Influenza, says, "STOP AI will help countries reduce and containthe spread of avian influenza in animals by delivering technical assistanceand management services to strengthen the response capacity of developingcountries -- which are particularly vulnerable to the threat due to insufficient resources and infrastructure. We are particularly pleased by the opportunity presented by STOP AI to closely coordinate with expertsfrom the U.S. Department of State, U.S. Agency for International Development, the U.S. Department of Agriculture, the U.S. Department ofHealth and Human Services, and other concerned U.S. Government agencies. STOP AI will also help utilize the available infrastructure of our international partners and multilateral organizations such as the United Nations System Influenza Coordinator, the World Health Organization, the UNFood and Agriculture Organization, and the World Organization for Animal Health to help countries effectively respond to local animal outbreaks of highly pathogenic H5N1 avian influenza."

Dr. Kent Hill, assistant administrator for USAID's Bureau for Global Health says, "STOP AI will play a vital role in supporting the U.S. government's efforts to prevent the spread of avian influenza and to minimize its potential to threaten the global community in terms of animal health, human health, and economic growth and development."

Hill also emphasized STOP AI's role in strengthening global planning and preparedness, improving early-warning disease surveillance, and supporting an efficient and timely response to avian influenza outbreaks.

STOP AI's focus areas include developing a roster of technical experts capable of deploying to developing countries in advisory and response roles, and helping threatened and affected countries to prepare for, respond to, and recover from outbreaks. The project will also provide logistical support to technical U.S. and international teams deployed for outbreak response.

The project is designed to enhance the U.S. government's international avian influenza response, which is described in the Implementation Plan for the National Strategy for Pandemic Influenza.

USAID has committed a total of $191.5 million in avian influenza efforts worldwide. Along with its partners, USAID supports efforts in 55 countries for improved planning, preparedness, communications, early-warning surveillance and disease detection, outbreak response, and commodity availability and use.


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Report Finds Severe Pandemic Flu Could Lead to Major U.S. Recession; Biggest Economic Declines Predicted in Nevada, Hawaii

Trust for America's Health (TFAH) has released a new report that finds a severe pandemic flu outbreak could result in the second worst recession in the U.S. since WorldWar II. The U.S. Gross Domestic Product (GDP) could drop over 5.5 percent, leading to an estimated $683 billion loss.

States with high levels of tourism and entertainment could be thehardest hit. Nevada's economy could face the biggest percent decline with aGDP loss of 8.08 percent, followed by Hawaii, which could experience a 6.60 percent loss. Six states could suffer losses over 6 percent (Nevada, Hawaii, Alaska, Wyoming, Nebraska, and Louisiana). The economies in anadditional 21 states could drop more than 5.5 percent and every state couldlose more than 5 percent in GDP, the organization says.

States with government and real estate as major industries could suffer the lowest percentage losses. The economies of Virginia and Maryland could experience the lowest drops in GDP of any of the states, but would still face significant declines of 5.13 percent and 5.09 percent, respectively. Washington, D.C. could face a 4.62 percent decline.

"The U.S. is not prepared to face an economic shock of this magnitude,"says Jeff Levi, executive director of Trust for America's Health."While important government preparedness efforts focusing mainly on medicaland public health strategies are underway, efforts to prepare for the possible economic ramifications have been seriously inadequate. Stepping up pandemic preparedness planning is vital to our national and economic security."

The report was funded by The Pew Charitable Trusts as part of the U.S. Pandemic Preparedness Initiative.

In the report "Pandemic Flu and the Potential for U.S. Economic Recession," TFAH created a model to assess the potential losses each state could face during a severe pandemic. Based on estimates from financial andeconomic experts, TFAH examined the impact of a pandemic on 20 different industries, trade, and worker productivity.

The model examines an outbreak as severe as the 1918 pandemic, which inmodern terms could result in nearly 90 million Americans becoming sick and 2.2 million deaths. People who become ill are expected to take at least three weeks to recover, and others would miss significant time from work to take care of family members or stay home out of fear of potential exposure to the flu.

Additionally, the model incorporates predictions from experts of howconsumer demand for products and services could drop in a number ofindustries. For instance, according to estimates, tourism, entertainment, and food services could experience an 80 percent decline, while agriculture, construction, retail trade, and finance and insurance could face a 10 percent loss in demand.

The estimates focus on possible losses over the course of a year during a scenario when a vaccine is not widely available. A real pandemic could last up to 18 months with a series of waves that last six to eight weeks each.

TFAH's report recommends a series of measures businesses and community groups can take to help prepare for a possible pandemic, focusing on how to sustain essential operating functions during a major outbreak. The recommendations encourage the private sector and government at all levels to examine and modify family and medical leave policies; expand telecommuting capabilities; assess infection control procedures in the workplace; establish contingency systems to maintain delivery of goods and services during a pandemic event; and update methods for communicating with their workforce.

The full report can be found on TFAH's website.

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First Glimpse of Influenza Replication Machine

In 1918, 50 million people died during a worldwide influenza pandemic caused by mutation of a bird-specific strain of the influenza virus. Recently H5N1, another highly infectious avian strain has caused outbreaks of bird flu around the world. There is great concern that this virus might also mutate to allow human-to-human transmission and cause another catastrophic pandemic.

Specific mutations in a viral protein, the polymerase, contribute to the ability of the bird virus to jump the species barrier to humans.

Researchers from the European Molecular Biology Laboratory (EMBL) in Grenoble and Heidelberg, the Institut de Biologie Structurale (IBS) and the Unit of Virus Host Cell Interactions (UVHCI), both in Grenoble, have now produced the first three-dimensional image of part of this key protein. The study, which is published in the current issue of Nature Structural and Molecular Biology, investigates the structure and function of the protein and sheds light on how polymerase mutations contribute to transmission of avian flu to humans.

Upon infection the influenza virus starts multiplying in the cells of an infected host. The polymerase is crucial in this process because it copies the viral genome and directs the production of its proteins. Interfering with polymerase function would prevent the virus replicating, thereby reducing the spread of the virus and the severity of the infection.

"For many years scientists have tried to understand the flu polymerase and to look for weak points that could be targeted by drugs," says Darren Hart, whose team participated in the research at EMBL Grenoble. "But no one could get enough protein to analyse its structure. We developed a way to use robots to screen tens of thousands of experimental conditions and discovered a piece of the influenza polymerase that we could work with. It is a small part of the entire protein, but it provides interesting insights into how the protein works and how mutations may affect host range."

Together with scientists at the IBS they visualized the atomic structure of the protein and discovered a previously overlooked signal that labels it for transport to the human nucleus where the genetic material of the virus is replicated. Cell microscopy studies at EMBL Heidelberg revealed that the human nuclear transport protein, importin alpha, recognises this signal and shuttles the polymerase into the nucleus. To find out how the polymerase and importin interact, Stephen Cusack, head of EMBL Grenoble, and collaborators at the UVHCI, used the high intensity X-ray source of the European Synchrotron Radiation Facility to generate a high-resolution image of the two proteins interacting with each other.

The image revealed that mutations known to play a role in the transmission of avian influenza virus to mammals were located within, or close to, this site of interaction. This suggests that mutations may affect the efficiency of nuclear transport and through this the ability of the virus to replicate in different species.

"Interfering with polymerase function could provide new ways to treat or prevent flu," says Cusack, "but this will require a detailed picture of the rest of the polymerase. This is what we are aiming for in our new FLUPOL project. In a joint effort with other European laboratories, and with financial support by the European Commission, we will explore both structure and function of this key drug target and try to characterise other mutations implicated in bird-to-human transmission."

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Changes To Better Respond To Flu Pandemic Urged

The American Public Health Association (APHA) recommends key changes to the U.S. strategy for preparing and responding to a flu pandemic to ensure the health and safety of all individuals, the association for public health professionals founded in 1872 says.

APHA released a blueprint for improving U.S. pandemic preparedness, amid persistent concerns about a potential influenza pandemic.

Among its top concerns is the need for additional resources for an already overburdened public health workforce that may lack the resources to fully respond to a flu outbreak, APHA says. Other needs include clear federal guidance on school closures, quarantine and occupational health in the event of a pandemic.

It is not just the public health sector that should be prepared for a pandemic, says Georges Benjamin, MD, FACP, APHA's executive director.

"The general public must be equipped with the proper resources to prepare themselves in the event of a flu pandemic," Benjamin says. "The better we prepare now, the better our chances will be for protecting the health of Americans during an emergency."

APHA's proposals include:

• Increasing funding for states, localities, hospitals and public health labs to expand their capacity to respond to pandemic flu;
• Increasing investment in the public health work force, so there are enough employees necessary to serve on the frontlines in preparing for and responding to a pandemic and annual seasonal epidemics;
• Creating emergency Medicaid coverage to ensure that uninsured Americans will receive appropriate countermeasures and care in the event ofpandemic flu;
• Creating guidelines for the use of non-pharmaceutical interventions, including handwashing, "snow days," isolation and quarantine;
• Creating new methods to purchase, distribute and track vaccines and antivirals;
• Incorporating occupational and mental health issues, such as potential distress and sick leave from work, in pandemic planning and response efforts; and
• Creating and implementing laws and policies that grant federal, state and local health officers the authority to make decisions about quarantine and isolation orders.
  

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U.S. Spends More Than $100 Million on Advanced Development of H5N1 Influenza Vaccines

U.S. Health and Human Services Secretary Mike Leavitt announced today that the department has awarded contracts totaling$132.5 million to three vaccine makers for the advanced development of H5N1 influenza, or bird flu, vaccines using an immune system booster called an adjuvant.

Anadjuvant is a substance that may be added to a vaccine to increase the body's immune response to the vaccine's active ingredient, called antigen.

"In the event of an influenza pandemic, a vaccine that uses adjuvant could provide a way to extend a limited vaccine supply to more people," Leavitt says. "These contracts are a continuation of our aggressive multi-pronged approach to a potentially critical public health challenge."

The department awarded five-year contracts to GlaxoSmithKline for $63.3 million and to Novartis Vaccines and Diagnostics, Inc. for $54.8million. In addition, the U.S. is funding IOMAI Corporation for $14.4 million for 15 months to complete Phase 1 clinical trials of its candidate vaccine. IOMAI may receive an additional $114 million in funding uponsuccessful completion of the Phase 1 trials. Phase 1 trials are the firststage of testing in people and normally include a small (usually less than 100) group of healthy volunteers. Overall the three contracts support advanced development work through Phase 3 clinical trials in the U.S. that are aimed at obtaining U.S. licensure for the product. In addition, the contracts support the establishment of U.S.-based manufacturing capabilities.

Under the contracts each company will build up its capacity to produce within six months after the onset of an influenza pandemic either 150 million doses of an adjuvant-based pandemic influenza vaccine or enough adjuvant for 150 million doses of a pandemic influenza vaccine. In addition to supporting the development of each company's antigen-sparing vaccine candidate, the contracts also require each company to provide itsproprietary adjuvant for U.S. government-sponsored, independent evaluationwith influenza vaccines from other manufacturers.

Initial clinical studies of H5N1 vaccine in humans have shown that two 90- microgram doses of the vaccine are required to stimulate a level ofimmune response that researchers anticipate would provide protection for anindividual against the H5N1 strains that have been spreading among birds inAsia. However, the addition of adjuvant to these candidate vaccines mayreduce the amount of antigen (active ingredient) per dose needed to achieveeffective individual protection.

HHS' effort to pursue adjuvant-based vaccine is part of a broader effort by the department to accelerate the development and production of new technologies for influenza vaccines within the U.S. For example, in May 2006 HHS announced a $1 billion investment to support the advanced development of cell-based production technologies for influenza vaccinesand will help to modernize and strengthen U.S. influenza vaccine production by creating an alternative to producing influenza vaccines ineggs.

The H5N1 strain of avian flu has spread to more than 40 countries and has led to the deaths of hundreds of millions of additional birds, which has heightened concern about the possibility of a human flu pandemic. Furthermore, the number of avian flu cases in humans has reached more than 260 cases in 10 countries. More than half of those persons infected have died. To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health.


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