For all the publicity it has received, few people can appreciate the depth and danger presented by the possibility of a global avian influenza pandemic.
"We’re dealing here with world survival issues — the survival of the world as we know it," Dr. David Nabarro, the United Nation’s newly installed pandemic czar, soberly warned the world.
In a worst-case scenario, a pandemic could kill a mind-numbing 2 million Americans and hospitalize another 10 million, an unknown number of whom would also die because of vaccine and anti-viral medication shortages and a cascading collapse of the health care system, according to a White House estimate.
Further, a worldwide pandemic would accomplish naturally what terrorists can only wickedly imagine. It would virtually shut down world travel; force the closing of borders; isolate entire nations; catastrophically disrupt global supply chains and provoke pockets of mass starvation; overwhelm and bankrupt health care systems; deplete medicines and vaccines; devastate economies across the planet at a cost of $800 billion a year; reduce global oil demand by as much as 7 million barrels per day; and ignite social upheaval that could spiral into pandemonium and anarchy.
What worries health planners right now more than the looming pandemic, every public health expert HSToday interviewed stressed, is that despite all the attention it has received information about the nature of the pandemic and the urgency to prepare the general public for it is in short supply. The Department of Health and Human Services (HHS) recently polled 60,000 people and 20,000 doctors and asked them what they knew about avian flu or flu pandemics. The answer: not much.
Similarly, a poll by Princeton Survey Research Associates for the Pew Research Center for the People and the Press conducted in November found 38 percent of Americans are "not too worried" that they or someone in their family will be exposed to the avian flu. Twenty-three percent aren’t worried at all, and 27 percent are only "somewhat worried."
"While we certainly don’t want to needlessly alarm the public," explained former top government catastrophic event planner Peter Marghella, "we do need to do a much better job at explaining the seriousness of what we’re facing if we’re to have the public’s support in combating a pandemic when it happens. They need to know just how serious this is, what may be asked of them, what precautions they need to be aware of. We can’t wait until the last minute."
Responding to the chorus of critics who say concerns about a pandemic are overblown, Klaus Stöhr, coordinator of the World Health Organization’s (WHO) global influenza program, said "the fear … the virus will become transmissible from human to human … is real, it’s scientifically substantiated, and we have enough historical data to tell us that the pandemic that would come out of this mutation would lead to a global health emergency, with millions of deaths, a global spread in less than three months and people in the developing countries being hardest hit.
Stohr stressed: "It’d be inappropriate and wrong to disregard these signals. The chances of it causing a pandemic are logarithmically higher than the chances of it not causing a pandemic."
At the Nov. 7 WHO meeting in Geneva of the planet’s leading scientists and public health administrators, who have no doubt about the threat, Director-General Lee Jong-Wook said in his opening remarks that "the signs are clear that [a pandemic] is coming … It is only a matter of time before an avian flu virus — most likely H5N1 — acquires the ability to be transmitted from human to human, sparking the outbreak of human pandemic influenza. We don’t know when this will happen. But we do know that it will happen."
The American response
Under the response plan unveiled by President George Bush on Nov. 1, the burden of preparing for and responding to a pandemic falls squarely on the shoulders of state and local health departments. They will be the ones who will have to conduct surveillance, identify flu strains, develop intervention strategies, monitor hospital admissions, implement exposure control measures and keep the public informed.
Even the burden of keeping socially dependent infrastructures running falls on states and localities.
The federal plan calls for $100 million to help each state prepare, yet the White House simultaneously proposed cutting $130 million from other funds that are given to state and local health departments under other programs for all sorts of healthcare issues. There’s no money to help hospitals prepare or to train healthcare workers to deal with a pandemic.
According to the National Association of County and City Health Officials, 90 percent of the staffing at the state and local level is inadequate to even put a comprehensive pandemic plan in place. Without funding, these staffs aren’t likely to be available.
The government’s plan also requires states to buy 31 million doses of antiviral drugs like Tamiflu, bearing 75 percent of their cost.
However, states such as Louisiana and Mississippi, in particular, will have trouble paying for their share of Tamiflu and other necessary pandemic preparations. Many other states are faced with slow revenue growth and rising Medicaid costs. And, as HSToday has reported, financial strains on hospitals are forcing the closure of trauma units and cuts in emergency room services.
Consequently, state and local health planners are grappling with questions about paying for their flu preparations. Just calculating the number of respirators and syringes required for stockpiling and how to pay for them is taxing localities.
Largely left by the federal government to fend for themselves in the event of a pandemic, it’s no stretch to say, based on interviews with state health officials and other authorities, the primary problems states and localities will confront are implementation of quarantines because of a lack of vaccines and antiviral medications; quelling civil unrest; managing corpse storage; and keeping the public infrastructure up and running.
Vermont Health Commissioner Dr. Paul Jarris said he is developing a pandemic response plan that’s largely based on the assumption that medicines will not be available.
"We’ll be surprised if we have enough vaccines and antivirals," he told HSToday, even though the Bush plan relies heavily on vaccines and antivirals — medicines every authority interviewed said are going to be in very short supply — to help thwart the pandemic’s spread. "Most of the general population will not get them," Jarris said, noting, "We’re making a big mistake by relying on respirators, antivirals and vaccines."
Where can the sick go?
Although the Bush plan calls for addressing the growing paucity of hospital surge capacity — the lack of available hospital beds nationwide — Jarris and other states’health authorities said they have to be creative in meeting the need for space duringan emergency.
Hospitalization of the sick will be the first crisis states and localities will face. State health commissioners say surge capacity and the ability to quarantine or isolate the sick will be critical in the event of a pandemic.
In Texas and North Carolina, for instance, officials are considering using "less than code-compliant beds."
Tulare County, California, purchased 60 cots and 15 adjustable hospital beds and four military-style mobile hospitals in case area hospitals overflow, but officials concede that’s probably not nearly enough.
Since 1980, the number of hospital beds available per US resident has declined by about 40 percent. Today, there are only about 965,000 staffed beds. Yet, the government states in its new pandemic response plan that up to 10 million Americans may require hospitalization. The Trust for America’s Health, a non-profit public health advocacy group, conservatively estimates that the emergence of a pandemic flu virus like the one of 1918 would require hospitalization of 2.3 million people.
Regardless of the differences in those projections, Jarris said surge capacity is critical. "The medical system will be stressed beyond its ability," he stated, noting this "is an area we’re working hard on — trying to determine where we’ll have additional capacity."
Oklahoma’s Commissioner of Health, Dr. Mike Crutcher, agreed with Jarris, saying, "Our hospitals will be stretched thin … there’s no question about that … excess bed capacity and resources will be in short supply. … Most, if not all, of our public health infrastructure that has been bolstered through our terrorism preparedness and response efforts would be applied and tested should we need to respond to an influenza pandemic."
Marghella and Tim Stephens, a 15-year veteran public health planner who is spearheading the Association of State and Territorial Health Officials’policy initiatives on pandemic response, concurred. Marghella said, "Think in terms of hundreds of New Orleans’ superdomes across the country to house the sick and dying."
Stephens said municipalities are being forced to plan to use any large spaces they can, "like schools, auditoriums, gymnasiums — any place that has large, open space. Even empty strip centers and business buildings."
Coupled with this, states and localities are trying to figure out how to segregate those people already being treated and quarantining those who are infected but not able to be treated. "The issue of what do you do with all these people is an enormous challenge," Stephens said. "Every community has to address this according to its own unique capabilities."
"The bottom line is, we’re facing [having to fight this pandemic with] last century medical health care," Jarris said.
In the first stages of a pandemic, hospitals will be overrun and patients will be turned away or sent to emergency care sites, as was done for evacuated hospital,nursing home and other patients during the emptying of Houston prior to Hurricane Rita. Hundreds of people were sent to a Texas A&M College of Veterinary Medicine facility, where animal veterinarians were called into service to help care for human patients.
Medical facilities will quickly run out of all sorts of medical supplies, especially the disposable N95 respirators on which the Bush plan heavily relies to protect medical workers, because many hospitals besieged by soaring costs have had to cut those costs by stocking only minimally acceptable inventories. Manufacturers’inventories also are marginalized because of just-in-time production practices. And, more often than not, production is outsourced overseas.
As the pandemic progresses, the nation’s cadre of trained medical personnel will dwindle as doctors and nurses get sick or, like many other public-sector workers, simply don’t report to work. Many will be forced to stay home to take care of their children when schools are shuttered — because children are primary conveyers of contagions.
The plan, though, puts school-age children at the bottom of the list of people to be inoculated at the outset of a pandemic, leaving public health authorities shaking their heads "at the absolute stupidity" of this, as HSToday was told on condition of anonymity by an HHS official, who said she has lodged her objection to kids being de-prioritized in the final plan.
"If the idea is to prevent the spread of the virus — and it is — then children should obviously be at the top of the list to receive vaccinations, Tamiflu … whatever. As the saying goes, ‘ this isn’t rocket science, ‘” she said.
An article published this year in the American Journal of Epidemiology, "Strategy for Distribution of Influenza Vaccine to High-Risk Groups and Children," showed that by vaccinating 70 percent of schoolchildren between ages 6 and 18 the transmission of flu could be significantly lowered. The author of the study, Ira Longini, an epidemiologist and biostatistician at Emory University, demonstrated through his model that even if 50 percent of schoolchildren were vaccinated transmission would be cut substantively. (An abstract is available at http://aje. oxfordjournals.org/cgi/content/abstract/161/4/303.)
Pediatricians and virologists interviewed by HSToday wholeheartedly agreed that, as soon as a pandemic reaches the US, vaccination of school-aged children should be "a no-brainer."
In the worst-case scenarios, as the pandemic runs its course, corpses will pile up because the mortuary service industry will not be able to handle the numbers of dead. Traditional funeral services and burials will have to be abandoned, a necessity that will have a significant psychological impact on societal sensibilities and that no pandemic plan takes into consideration, stressed Stephens.
Localities are being forced to explore storing corpses in refrigerated trucks and commercial meat processing and supermarket freezers.
State officials say they’re having difficulty making preparations for the most mundane things like keeping hospital laundries from imploding under an avalanche of contaminated clothing and bed linens.
The White House plan notes that there could be widespread breakdowns in municipal services and social order, including the loss of public transportation, electricity and food shortages, but offers a paucity of suitable recommended responses.
As a result, municipalities are left with drafting disparate plans for how they’re going to keep basic infrastructure services running — like power plants, water and wastewater treatment facilities.
Most states’pandemic plans stress the need to minimize societal and infrastructure disruptions.
"It’s more than just the health response," Stephens said. "This is about planning for every aspect of society and our lives. … We’re looking at many months of social interruption of things we take for granted. The national plan makes assumptions that don’t necessarily reflect the way economies work and societies function … We have to be looking at how to address chronic disruptions and social rearrangement … and I’m not confident that this is a shift we’ll be able to make in time nationwide."
Antiviral shortages and little vaccine
The national plan to combat a pandemic is heavily reliant on antiviral medicines. The plan calls for spending $1 billion to stockpile antiviral medications, especially Tamiflu, which very likely will be in short supply.
Tamiflu is the principal antiviral capable of reducing duration, severity and contagiousness. The sole manufacturer, though, Swiss-based Roche, can make enough to treat only 55 million people at a time. Roche has announced, however, that it has plans to boost production to 300 million courses by 2007 and is considering licensing production to other pharmaceutical houses. But as nearly every expert pointed out, Tamiflu may have no effect on the strain of bird flu that causes a pandemic. And even if it does, supplies will be strained.
As for a vaccine, one won’t be available for perhaps as long as eight months from the outset of a pandemic until the world’s handful of flu vaccine makers are able to produce it. But even then, they have the capacity between them to manufacture only about 100 million doses for the entire world — 60 million doses over four months — because of reliance on 1950s technology.
"This is a mere fraction of the 600 million doses needed to keep our globally connected economy from crashing to a halt," said Dr. Paul Offit, chief of the Division of Infectious Diseases and the Maurice R. Hilleman professor of vaccinology at the Children’s Hospital of Philadelphia. He also is the author of the new book The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis. Obviously, US authorities say, with perhaps only 100 million doses in the first eight months for the entire world, rationing will be mandatory.
The Bush plan calls for "accelerating the development of cell culture technology for influenza vaccine production and establishing a domestic production base to support vaccination demands," but because of 50-year-old liability laws stemming from a live polio virus vaccine mistake, domestic pharmaceutical companies are not developing and producing vaccines.
HHS Secretary Michael Leavitt reluctantly admitted in late November that the low supply means state and local governments will have to make tough choices on how best to allocate the vaccine during a pandemic. The federal government suggested priority be given to first responders and medical personnel.
Leavitt said: "We have allowed the vaccine manufacturing industry to diminish to a point that they don’t have the ability. We have to do nothing short of rebuilding that industry."
According to Offit, "We are woefully under capacitated for preparing a vaccine."
He further explained that "it is legally prohibitive for US pharmaceutical companies to create new influenza vaccines because a biological disaster involving a vaccine produced by Cutter Laboratories spawned litigation that led to a ‘ liability without fault’jury ruling — vaccines became the first medical product almost eliminated by lawsuits.
"If litigation law remains such that US manufacturers are discouraged from creating new influenza vaccines, no one will be willing to step in and start building the infrastructure necessary to prevent the predicted pandemic."
In 2003, two of the remaining four vaccine makers slashed their research and development budgets for vaccines.
"We’re at a crisis point," Offit said. "The only solution, at least as I see it, is to provide ironclad legal protections to pharmaceutical companies that are willing to start working on new influenza vaccines for the future and allow them to prioritize regulations to which they must adhere.
"Unsurprisingly, politicians spout sound bitesabout their unwillingness to remove ‘ consumer protections’from the equation, but they have it all wrong. The only real way to ‘protect’ consumers is to keep them alive. We must move fast and we must move now. The clock is ticking."
Bush’s plan addresses this issue by calling on Congress to provide "indemnification and liability protection for affected entities, including pandemic vaccine manufacturers, pandemic vaccine distributors and healthcare providers who administer pandemic vaccines."
The legislative dilemma
As of this writing, hotly contested legislation that addresses the problem has yet to be sent to a vote on the Senate floor, and a companion bill has yet to be introduced in the House. Democrats and, not surprisingly, trial lawyers are holding up movement on pandemic immunity legislation. But Republican lawmakers must share some of the blame. Discovery of special provisions Republicans slipped into the 2006 homeland security appropriations bill, including language that would have protected pharmaceutical companies from lawsuits stemming from certain vaccines, caused an uproar among Democrats and some moderate Republicans that nearly derailed the bill.
Marghella and Stephens said they so far see no viable, bipartisan effort on Capitol Hill to realistically and simply address the liability issue.
Meanwhile, "We’re facing a species-crisis, and the politicians and lawyers are playing their games," said a ranking official at the Centers for Disease Control and Prevention who asked not to be identified out of fear of retribution for his harsh criticism of government pandemic preparations.
The CDC official was highly critical of both the executive branch and Congress for having ignored "this impending catastrophe" for as long as it has. "Now it may be too late. We’ve been harping on this since the 1970s."
Indeed, the Government Accountability Office has issued at least 14 reports since 1979 highlighting pandemic and flu vaccine preparedness problems. "We’ve known about the problem with making flu vaccines all this time," the CDC official said. "But Congress — probably enriched by the trial lawyers — has consistently refused to address the problem which led to the economic disincentives for drug makers to manufacture vaccines. So, steadily over the years we’ve lost our national vaccine production base. We’re relying on just a few companies worldwide for all the world’s vaccines. In a crisis, well, I really don’t know what the hell to tell you."
Similarly, respirator production shortages could be compounded by the growing costs of litigation alleging injury because of defective design or inadequate warning, although last July a federal judge in Texas labeled as "fraudulent" thousands of silicosis diagnoses that form the basis for lawsuits in eight states. Even so, the costs of defending against this litigation are approaching the total net income from respirator sales, threatening dependable supplies.
"As a nation, we have a two-year supply of Post-It Notes, but a two-day supply of N95 [respirator] masks. We will at least have convenient ways of writing our obituaries and last words," Stephens said, gloomily.
Every public health expert and authority interviewed for this article, while not wanting to seem alarmist, clearly expressed worry. They realize modern society has never faced a health crisis of the magnitude that an avian flu pandemic will wreak. While the federal government’s national plan and states’individual pandemic preparations on their face appear well considered, authorities fear what will really happen "on the streets" as a pandemic begins to spread and public fear starts to take root.
Congress will soon begin deliberations on the Bush administration’s proposed response plan. Every authority HSToday talked to agreed that every aspect of it needs to be weighed, evaluated and debated — and with what they feel is much better input from the states and non-government authorities.
To read more about avian flu and the terrorist threat, go to www.HSToday.us and read the Nov. 10 Kimery Report: "Terrorists Discussed Bio-Martyrs to Spread Pandemic-Capable Flu Virus ” .
For all the publicity it has received, few people can appreciate the depth and danger presented by the possibility of a global avian influenza pandemic.