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 The draft guidance document (PDF) has not been widely released and was provided to ProPublica only after requests to several members of panel.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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Early results From Clinical Trials Of 2009 H1N1 Influenza Vaccines In Healthy Adults

We are encouraged by reports that are now emerging from various clinical trials of 2009 H1N1 influenza vaccines, conducted by various vaccine manufacturers. We expect additional companies to announce their preliminary trial results shortly. The early data from these trials indicate that 2009 H1N1 influenza vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15-microgram dose. We congratulate the companies on these trials, which are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines. More than 2,800 people are participating in ongoing NIAID trials of these vaccines.

We are pleased to note that preliminary analyses of early data from the NIAID trials align with the recently announced findings and those to be announced imminently by other companies in that both vaccines studied induced what is likely to be a protective immune response in most adults following a single dose in the same amount (15 micrograms) used in seasonal flu vaccines. Specifically, in blood samples obtained 8 to 10 days after vaccination

Among healthy adults who received a single 15-microgram dose of the Sanofi Pasteur vaccine, a robust immune response was measured in 96 percent of adults aged 18 to 64 and in 56 percent of adults aged 65 and older.

Similarly, among healthy adults who received a single 15-microgram dose of the CSL Limited vaccine, a robust immune response was measured in 80 percent of adults aged 18 to 64 and in 60 percent of adults aged 65 and older.

Additional data from the NIAID trials are forthcoming. However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines.

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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.
=
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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Consumer Reports Survey: Nearly Half of Adults Won't Get Flu Vaccine, Citing Poor Excuses Like 'I Don't Get Sick'

According to a new survey from Consumer Reports Health, just 52 percent of Americans plan to get the flu vaccine this year, despite its being the best option for prevention. The Consumer Reports Health survey uncovered a long list of poor excuses for not getting the vaccine, including 5 percent of people who say they would rather get sick than go to work.

The vaccine is available for free for many (65 percent of those who have already been vaccinated reported no out-of-pocket expense for the vaccine), and at nominal cost for others, and requires very little time, Consumers Reports says.

The survey was conducted in early October by the Consumer Reports National Research Center, right as the flu season was getting underway this fall. Flu season typically begins in late October and can run through early May. Some 67 percent say it was better to build your own natural immunities.

"There is no evidence that people who get flu shots have lower natural immunities or that people who don't get flu shots have higher immunities," says Dr. John Santa, M.D., director of the Consumer Reports Health Ratings Center. Those surveyed cited the following other reasons for not getting the vaccine: They do not get sick (45 percent), they have themselves or know someone who has gotten sick from the vaccine (41 percent), or they believe the vaccine is ineffective (26 percent).

Other consumers not planning to get a flu vaccination said that they were worried about side effects (35 percent), medication is now available to treat the flu (28 percent), they don't like getting shots (27 percent), or they don't like going to the doctor (23 percent). And some (5 percent) even say that they'd rather get sick than go to work. "Sounds like a lot of excuses and misconceptions to avoid a quick and inexpensive, if not free, shot," says Santa.

Influenza (the flu) is a contagious respiratory illness caused by influenza viruses that, in milder cases, can make people sick for several days, and at times can lead to death. Nearly all adults who responded to the Consumer Reports survey (83 percent) report that they have had the flu.

According to the Centers for Disease Control and Prevention, more than 200,000 people are hospitalized each year from flu complications and about 36,000 people die from flu. Older people, young children, and people with certain health conditions are at high risk for serious flu complications.

"Despite the prevalence and potential seriousness of the flu, we found that many adults are surprisingly misinformed about both the flu and flu vaccination," says Santa. "People need to know that getting a flu vaccination every year is the best way to prevent the flu. The vaccine will not make them sick or give them the flu. Without it, they and their families are at higher risk for getting the flu. If they get the flu they may transmit it to vulnerable people for whom the consequences may be serious."

Fewer than half of those surveyed (49 percent) by Consumer Reports knew that the government recommends that everyone over 6 months old get vaccinated against the flu.

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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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Stockpiling Influenza Vaccine in Hong Kong

In light of the importance of virus monitoring for pandemic influenza preparedness and response, Indonesia’s refusal to share samples of avian flu (H5N1) virus with the World Health Organization for most of 2007 is "distressing and potentially dangerous for global public health," say two leading global health experts in an essay in this week's PLoS Medicine.

Laurie Garrett (Senior Fellow for Global Health at the Council on Foreign Relations, New York) and David Fidler (Professor of Law and Director of the Center on American and Global Security at Indiana University) say that Indonesia repeatedly refused to share H5N1 samples unless significant changes were made to allow it greater access to vaccine derived from samples it shared with WHO.

Typically some 250-300 million influenza vaccine doses are made each year, based primarily on samples of flu viruses circulating in Asia, yet most of those vaccinated are residents of rich countries. Some developing countries, say the authors, have challenged this strategy by asking “What’s in it for us? We share virus samples, and pharmaceutical companies make vaccines from them that primarily benefit rich countries. Without better access to vaccine, why should we share virus samples?”

Garrett and Fidler offer a novel proposal to overcome the virus sharing impasse. They propose that annually updated supplies of more than 500 million doses of highly specific influenza vaccine, plus antiviral medicines, protective masks and gloves, and germicide washes be stockpiled in Hong Kong. They select Hong Kong, they say, because it has shown "absolute transparency regarding disease emergences going back several decades," it is a dynamic center of virus research and response, and it sits in the middle of the ecological zone that has spawned the bulk of all flu strains known to have emerged over the last three decades.

"We advocate that the strategic stockpile be fed continuously and its specificity updated based on circulating forms of viruses," say the authors. "These objectives would be accomplished through an Advance Market Commitment (AMC) mechanism in which the G-8 nations and Asian powerhouses China, India, Singapore, South Korea, and Japan set aside a fund to guarantee purchase of stockpiled products. The Asia-Pacific Economic Cooperation forum (APEC) should manage the AMC fund and the stockpiled materials in Hong Kong. APEC has proven to be one of the most dynamic and effective of the world’s regional organizations."

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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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Video: Maryland County Holds Largest Flu Vaccination In U.S.

Howard County, Maryland, has undertaken what is believed to be the largest flu vaccination program in the United States. Tim Williams of WJZ-TV in Baltimore reports.

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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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Doctor Advises Caution Over Flu Drug

In this week’s BMJ, a senior doctor advises caution over the use of the antiviral drug oseltamivir (Tamiflu).

His concern follows advice by the Japanese authorities in March 2007 against prescribing oseltamivir to adolescents after the separate suicides of two 14 year olds who jumped to their deaths while taking the drug.

So far, oseltamivir has been thought to be well tolerated and safe, but the recent events in Japan have prompted a reappraisal, writes Simon Maxwell from the University of Edinburgh.

Before 2007, there had already been more than 100 reports of neuropsychiatric events (including delirium, convulsions, and encephalitis) with oseltamivir in children, almost entirely from Japan, which has the highest usage of oseltamivir worldwide. But a Food and Drug Administration (FDA) review concluded that these events were not clearly drug related.

Since last November, the FDA has required that doctors be warned that patients should be closely monitored for signs of abnormal behaviour throughout the treatment period and the European Medicine Evaluation Agency (EMEA) took similar steps in February.

In the UK, oseltamivir is a “black triangle” drug so it remains under more intensive surveillance and healthcare professionals are asked to report all minor as well as serious adverse events.
The controversy about oseltamivir is a further reminder that, although common adverse effects of a drug may emerge in prelicensing studies, the detection of rarer and potentially more serious events has to await exposure of large numbers of patients, he says.

In the light of these concerns, how should prescribers proceed?

There seems little doubt that oseltamivir reduces the number and seriousness of flu episodes when used as treatment and prophylaxis, he says. However, the impact of such events in otherwise healthy people is usually modest and of short duration, so they should be encouraged to use conservative strategies such as resting, increasing fluid intake, and taking simple analgesics.

In people at higher risk of serious complications the potential benefit of treatment seems greater, although convincing evidence about reductions in hospital admission or mortality is still awaited, he writes. In these groups, vaccination still offers a cost effective first line of defense.

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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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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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