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Avian Flu Update

Author: Laurie Garrett, Senior Fellow for Global Health
October 13, 2005
Council on Foreign Relations

The threat of H5N1 pandemic influenza looms large in Asia, Washington, and Geneva, and there has been an obvious increase in anxiety and activity related to flu of late. There appear to be two forces driving this: the H5N1 situation in Indonesia at the moment and post-Katrina anxiety in the U.S. government, with all hands fearing they could be the next Michael Brown (ex-FEMA Director). As anxiety rises, so do the volume of press queries, speaking requests, and general calls to the Council on Foreign Relations’ Global Health Program. It was a busy summer for us, following publication of the “Next Pandemic” issue of Foreign Affairs (July/August 2005), and things have only heated up in the fall.

We would like to bring you up to speed on several issues related to H5N1 and the potential for a pandemic, and answer some of the questions most commonly directed to the program. We hope that you will find this helpful. Further, we want to remind you that there will be a major day-long pandemic flu meeting here at the Council in November: details will follow shortly.

By way of background, the program has recently made the rounds in Washington (State Department, HHS, Deptartment of Defense, and embassy contacts) and in academic foreign policy circles (Harvard, MIT, Princeton, etc.). We have also had numerous meetings of late with members of the business community, media, National Guard and local government. We are trying to have our fingers on the political pulse of the pandemic anxiety and preparedness.

Who Is Scared and What Are They Doing About It?

This week President George Bush addressed the pandemic concern during a press conference in the Rose Garden that was otherwise devoted to his nomination of Harriet Meirs to the Supreme Court. (The President’s flu-related comments appear below, in their entirety.) There were two startling aspects to the President’s comments: the military and the pharmaceutical industry. Regarding the military, the President stated: “ If we had an outbreak somewhere in the United States, do we not then quarantine that part of the country, and how do you then enforce a quarantine? When—it’s one thing to shut down airplanes; it’s another thing to prevent people from coming in to get exposed to the avian flu. And who best to be able to effect a quarantine? One option is the use of a military that’s able to plan and move.”

In 1878, a Yellow Fever epidemic struck the United States, killing upwards of ten percent of populations located along the Mississippi river from Memphis to New Orleans. In hopes of not only stopping the epidemic but also healing post-Civil War feelings in America, President Rutherford B. Hayes ordered U.S. troops into the epidemic. Soldiers enforced quarantines, burned down the homes that were considered infested, and moved entire populations out of towns and cities that were thought to be sources of contagion. (At the time people did not understand that Yellow Fever was a mosquito-carried viral disease best controlled by draining swamps, gutters, puddles, and other sites in which the insects bred.) The army took an enormous death toll in the process. Since then, Presidents have resisted using federal forces to implement disease control activities domestically.

The Department of Defense is working on at least two pandemic flu plans, but we are not aware of any that posit a domestic role for military personnel. On September 16 the Defense Intelligence Agency issued a pandemic flu assessment that finds the most likely scenario for H5N1 to be that “the virus continues to be transmitted among bird species with sporadic cases among humans,” offering no serious problems for the American people or military. DoD has no published plans for dealing with virulent influenza among active duty personnel, or for conducting wars on two fronts when a significant percentage of combat personnel are ailing. We find this particularly troubling in light of the fact that insurgents battling U.S. personnel both in Iraq and Afghanistan often include suicidal players for whom the threat of lethal influenza would not likely be a deterrent to their military operations. In effect, if 30% of U.S. frontline troops were down with virulent flu while the epidemic had no impact on insurgent activities, the virus could prove a decisive strategic factor.

In response to Katrina, President Bush appears to be determined to overturn the Posse Comitatus Act so that domestic catastrophes can be handled by the Department of Defense. In the context of influenza, this would almost certainly be a grave error. Quarantine—the action most likely to require crowd control—is rarely effective for flu. The virus is simply too contagious, and silent carriers too numerous, for such draconian efforts to be successful. One recent study indicates that when quarantine is limited and is tightly coupled with widespread use of the anti-flu drug Tamiflu, it can be a reasonable means of slowing spread of the disease (Balicer, R.D., M. Huerta, N. Davidovitch and I. Grotto, “Cost-Benefit of Stockpiling Drugs for Influenza Pandemic,” Emerging Infectious Diseases 11:1280-1282.) But that Israeli study assumes a compliant citizenry, no drug resistance in the influenza, sufficient Tamiflu for 25% of the entire Israeli population and a far-reaching public health infrastructure. It is hard to imagine how that model could be replicated in the United States.

Some Washingtonians, we found in recent discussions, still believe that it is possible to contain an influenza outbreak at the level of an Asian community, preventing a pandemic. With that in mind, they favor an approach to the pandemic threat that is narrowly focused on Indonesia and SE Asia. This thinking was certainly at the core of a recent formal agreement between China’s Hu Jintao and President Bush on ten pandemic principles of cooperation. These very laudable principles include full transparency, global cooperation in surveillance, laboratory work and research, and vague commitments to share resources. (Some skepticism regarding China’s compliance is offered by Nicholas Zamiska’s fine reporting, “Bird-Flu Battle Meets New Foe: Scientific Pride,” Wall Street Journal [ September, 30, 2005]: A5.) We applaud the agreement, which we hope will be co-signed by nations worldwide, as it augurs well for general cooperation in public health. But we are not sanguine that even under such unprecedented conditions of openness an outbreak can be contained.

Two recent computer modeling studies offer evidence, pro and con, regarding containment. In August, Emory University’s Ira Longini and collaborators published a study that was modeled on a mythological SE Asian community of some 500,000 people (Longini IM et al, “Containing Pandemic Influenza at the Source”, Science 309: 1083-1087). The model makes the following assumptions:

  • Less than one out of every 1,000 people in the outbreak area manage to escape the region, potentially spreading the virus elsewhere.
  • The outbreak is identified immediately and widespread Tamiflu prophylaxis is administered to the entire community within 21 days.
  • Households in which cases are identified are placed under strict quarantine.
  • The entire World Health Organization current stockpile of Tamiflu is made available gratis to the needy country and mobilized from Geneva to the target community within eight to fourteen days of the outbreak’s inception.
  • None of the H5N1 strains are resistant to Tamiflu.

Given those caveats, the study concludes, it might be possible to contain an outbreak and prevent a pandemic if the entire intervention process commences before there are more than thirty people infected with H5N1.

The second study was conducted by Neill Ferguson of London’s Imperial College and an international team of collaborators. The model was based on Thailand, which has the best public health and scientific infrastructure in SE Asia. Their model makes the following assumptions:

  • None of the H5N1 strains in the country have resistance to Tamiflu.
  • The virus infects 60% of exposed humans, producing clinical symptoms in half of them.
  • Ideal containment would entail universal use of Tamiflu by the entire Thai population, coupled with regional control efforts that would include the less-than-cooperative state of Myanmar.

In the absence of such a massive effort, a combination of strategies including social targeting, geographical targeting and quarantines might contain the outbreak if fewer than 200 people are infected and the entire strategy is implemented in thirty days.

Speaking at a recent pandemic flu meeting convened by Deutsche Bank and the University of Pittsburg Medical Center (“Bulls, Bears, and Birds: Preparing the Financial Industry for a Pandemic,” Sept. 23, 2005, NYC), WHO’s Dr. Klaus Stohr said his agency would, given expected delays in poor countries in identifying an outbreak and notifying world authorities, have fewer than fourteen days to administer Tamiflu to 80% of the target population. In other words, it would be virtually impossible.

Dr. Michael Osterholm of the University of Minnesota has repeatedly characterized the regional containment concept “Pollyanna thinking,” given such constraints: We agree. If the global community had been investing in public health infrastructure development on a considerable scale in Asia over the last ten years there might be some hope of spotting an outbreak early enough for containment to stop flu. But recently, even the Minister of Health of China conceded that his economically booming nation has virtually no public health system at all.

Perhaps the most glaring reason for being skeptical of the containment strategy is that H5N1 is a migratory bird virus; its spread is not solely a matter of human activities. This summer evidence of how rapidly H5N1 could be spread from one location to others hundreds, even thousands of miles away was starkly revealed in China. Infected ducks and geese made their annual migration north, landing in central China’s Lake Qinghaihu. On May 4 a single dead bird was noticed; by mid-June thousands of dead and dying birds, representing several species, lay about the lake. Since Lake Qinghaihu is a primary breeding site for dozens of species of migratory birds, the virus was quickly carried northward, surfacing in Mongolia, Kazakhstan and the central Asian countries by July, in Siberia later that month, and then across the Urals heading to Europe by August. (See Liu, J. et al. “Highly Pathogenic H5N1 Influenza Virus Infection in Migratory Birds,” Science 309: 1206.)

Washington Reacts

As concern rose this summer the President took a personal interest in the pandemic flu threat, convening a White House multi-agency meeting. A cross-agency task force was created, which now meets daily. HHS Secretary Michael Leavitt currently devotes about an hour a day to the threat, and it occupies a similar level of concern in the office of Paula Dobriansky, Undersecretary of State for Global Affairs. Officials in the National Security Council and Central Intelligence Agency are now actively engaged with the issue. It is clearly viewed by the administration in national security terms. A series of individual agency pandemic flu plans are scheduled for release in coming weeks; the administration intends to combine them over the winter to produce a single federal response plan.

Meanwhile, last Thursday evening (September 28) the U.S. Senate took radical steps regarding flu, unanimously tagging a $3.9 billion pandemic influenza preparedness rider onto the Defense Department 2006 appropriations bill. Some $3.1 billion of it would go toward purchase of various unstated supplies and enough Tamiflu for about half of all Americans. Passed by unanimous consent at a time when everything else the Senate does seems to break down along party lines, this was remarkable. The spending breakdown would be as follows:

  • $3.1 billion for a stockpile of Tamiflu, the Glaxo GSK drug Relenza and “supplies”
  • $33 million for improvements in global surveillance
  • $75 million for communication and education about flu for the American people
  • $125 million for improvements in the domestic vaccine infrastructure
  • $600 million for emergency preparedness grants domestically

Only one Senator voiced criticism of the nearly $4 billion expenditure: Alaska Republican Ted Stevens. An adamant fiscal conservative, Stevens said that H5N1 “has not yet become a threat to human beings. We ought to wait for the scientists to tell us what needs to be done.”

Apparently Stevens has not been listening, as scientists have, with remarkable agreement, been trying to tell the political leadership what it ought to do for a long time. In contrast to Stevens, Sen. Dick Durbin (D-IL) called for massive improvements in domestic flu surveillance, saying that without it, “when the avian flu hits this country, it will make the scenes of Katrina pale by comparison.”

Illinois’ Senator Barak Obama noted that even if the H5N1 strain does not mutate into a human-to-human form sometime in the next few years, “the good thing about investing in measures to deal with this looming crisis…[is it will] pay dividends…The H5N1 strain may not be the strain that leads to a full blown pandemic. But another strain could easily come along and cause serious damage in the future.”

On the other side of the aisle, Senator Bill Frist (R-TN) said that the potential of a “cataclysmic pandemic is not a question of ‘if’, but ‘when.’” As he has in the past, Frist called for a “Manhattan Project” to accelerate public and private research and development on flu and other pandemic potential microbes.

Before the investors among you run out and buy Roche (Tamiflu) and GSK (Relenza) stock, note that the House has yet to chime in. And the White House, despite wanting to hand flu control over to the military, says it will veto the Defense Appropriations Act if such “domestic” issues are tagged onto the final Senate/House bill.

What is the House likely to do? It is very difficult to say, as the leadership is deeply preoccupied at the moment with Representative Tom Delay’s legal problems, Katrina-related affairs, and the Supreme Court. One possible indicator of sentiment, however, may be found in a speech to the House two weeks ago (Sept. 21) delivered by Iowa Republican Representative Jim Leach, for example, who cited the flu threat and said, "The greatest foreign policy issue of our times is neither the problem of war and peace between nation states nor the problem of terrorism, but rather is the very human vulnerability we all share to disease."

It is conceivable that a House/Senate Conference Committee could agree to leave some form of flu rider on the Defense Appropriations bill, forcing the White House’s hand. Whether the White House would actually follow through with threats to veto the bill, given the exigencies of maintaining a high cash flow to the military in time of war, is unclear.

Gardner Harris writes in the New York Times (“Fear of Flu Outbreak Rattles Washington”, October 5, 2005) of rising tensions between Congress and the administration over the pandemic threat. He quotes HHS Secretary Leavitt telling Senate Democrats, “We need a plan. I’m resolved to make sure we have one and so is the President.”

And in response, Senator Tom Harkin (D-Iowa) remarked, “‘Trust us’ is not something the administration can say after Katrina. I don’t think Congress is in a mood to trust. We want plans. We want specific goals and procedures we’re going to take to prepare for this.”

Why Concern in Scientific Circles is Escalating

Something odd is unfolding in Jakarta. It may be nothing: it may be a harbinger. It is causing alarm.

In mid-September the Indonesian government acknowledged the accuracy of rumored reports of H5N1 infection in children in Jakarta. This came on the heels of a family cluster of infections involving middle class suburbanites with no obvious exposure to live birds. The children appeared to share only one potential source of infection: a visit to the national zoo. Exotic birds in the zoo were found to be H5N1 infected, but nobody has explained how kids standing far from the caged animals could have become infected. Since then, seven H5N1 deaths have been confirmed in Indonesia and some sixty suspected cases are under investigation. The Indonesian cases are not all linked, though some of them appear to involve people who were in direct contact with infected poultry.

Worried by the large number of cases, their epidemiological mysteries, and the magnitude of the potentially infected Jakarta population, Asian leaders have been spurned to action. ASEAN and APEC have both taken measures that recognize the emergency, call for enhanced cooperation, and stipulated new animal control measures.

But a cluster of new scientific studies have offered newfound grounds for concern. They include:

  • Indonesian agricultural authorities this week report finding infected chickens

that are not dying. They report that H5N1 has mutated there into a form that is less lethal to chickens. If this is verified, there are public health implications. It could mean the virus is, after all these years, adapting to the poultry host, which would allow it to not only flourish in chickens, but also spread undetected. Currently surveillance in poor countries rests heavily on spotting mass die-offs of chickens: If the animals are no longer dying, surveillance will have to become significantly more sophisticated in poor countries, relying on routine blood testing of livestock.

  • A large Italian survey of various types of flu viruses found in Italian livestock (NOT including H5N1) showed that bird-to-human transmissions of flus are very common events—far more typical than previously realized. The barrier between the species, from an influenza point of view, is not as steep as had been thought. (Puzelli, S. et al, “Serological Analysis of Serum Samples from Humans Exposed to Avian H7 Influenza Viruses in Italy between 1999 and 2003,” The Journal of Infectious Diseases 192: 1318-1322.) Commenting on the Italian study, Frederick Hayden of the University of Virginia and Alice Croisier of WHO note that some flu viruses seem better equipped to make the jump to humans, and then from human-to-human. But the potential is there for all, including H5N1.
  • A multinational survey of all known human H5N1 cases (New England Journal of Medicine Vol 353: 1374-1385) finds that at least eight health care workers have become infected with H5N1 since it first emerged in 1997 as a result of caring for infected patients; two others are suspected. In the last year there have been five confirmed family clusters of H5N1, suggesting some household transmission may have occurred. In addition, more sensitive laboratory tests have revealed asymptomatic and mild infections in other household members. Though the overall death rate in identified H5N1 infections has been around 55%, fatality rates in those who required hospitalization have been far worse: 71% in Thailand in 2004, 80% in Vietnam in 2004 and 2005, 100% in Cambodia this year. The virus appears to replicate in the human GI tract, and it is shed in feces, in addition to the typical modes of flu transmission (respiratory, coughing, nasal and oral fluids). So foreign is H5N1 to anything the human immune system has previously “seen,” that the innate immune system conjures an extreme response which, in itself, can be lethal. Steroids may soften that blow. And most distressing, H5N1 has mutated steadily since 1997, acquiring resistance to all types of antiviral drugs except Tamiflu and Relenza. Even those drugs are proving less effective: “compared with the influenza A (H5N1) strain from 1997, the strain isolated in 2004 requires higher [Tamiflu] doses and more prolonged administration (eight days) to induce similar antiviral effects and survival rates.”
  • A Hong Kong study concluded that even normal vaccines against regular influenza have less benefit than assumed. Surveying thirty-seven years worth of vaccines the authors concluded that most had only “modest” benefit in protecting people (Elizabeth Rosenthal, “2 Studies Find Flu Treatments Fall Far Short”, NYT, Sept. 22, A1.).
  • The same Hong Kong research team (led by Dr. Guan Yi of Hong Kong University) announced on September 30 in a press conference that a newly isolated Vietnam strain of H5N1 was resistant to Tamiflu. They called upon Glaxo to make a pill-form of alternative drug, Relenza, which currently is difficult to administer as it must be properly inhaled using a special device. Further, it cannot be tolerated by smokers and people suffering lung conditions such as asthma and bronchitis.
  • A nasty feud developed between flu researchers and the CDC, which is accused of hoarding H5N1 samples and blocking laboratory research (“Flu researchers slam US agency for hoarding data,” Nature 437: 458-9.).
  • In the October 5, 2005 issue of Nature, Elodie Ghedin and a team of scientists from The Institute for Genomic Research at the NIH describe the genetic details of 209 different strains of H3N2 flu that surfaced in New York State between 1999-2004. H3N2 is a “garden variety flu” that is responsible for discomfort in most people, but lethal only to those who have weakened immune systems. The researchers were able to pinpoint specific genetic changes that made one strain more virulent than another, helped the viruses jump from one host species to another, and let some evade vaccines. The later could explain Guan Yi’s conclusions that most vaccines offer far lest benefit than people presume.
  • AND FINALLY, THE BLOCKBUSTER. A few years ago Dr. Jeffrey Taubenberger of the Armed Forces Institute of Pathology tromped his way across Alaska in search of the frozen bodies of 1918 flu victims. He found such bodies and successfully isolated the dreaded killer virus. Earlier this year he announced the genetic sequence of part of the virus. But in this week’s issue of Science (October 7, 2005), Taubenberger and colleagues from Mt. Sinai Medical Center in New York and the CDC finished the genetic sequencing of that virus, and successfully built new 1918 influenzas from the genes up. They scrutinized the virus and discovered that like H5N1, the 1918 strain was a bird flu. They identified four genes that were responsible for the extreme virulence of the virus, including its ability to reside far deeper in the lungs than normal flus, and cause the lungs to fill with fluids. Victims literally drowned in their own fluids. And though most flu viruses can only thrive in certain types of cells, the 1918 strain was able to grow in a vast range of human and animal cells. All of these symptoms were replicated by exposing experimental mice to the 1918 viruses that the researchers created. Like H5N1, the 1918 strain was lethal to chickens. And also like H5N1, the 1918 virus seemed to have undergone a series of small genetic changes, made over a period of years: These changes ultimately rendered it a human-to-human contagion.
What Should We Be Doing?

Based on our discussions with policy makers, business leaders and politicians, the Global Health Program fears that few decision makers appreciate the protracted nature of an influenza pandemic. Some economic forecasters have actually pooh-poohed the financial impact of a pandemic by relying on models that imagine a one-time event, akin to a hurricane striking Louisiana.

Influenza strains do not, however, pop into a population for a few days and then die out. Rather, they take hold, pass over entire regions of the world in waves, and mutate over time. In 1918, for example, flu came in three waves, the first of which was mild enough to prompt military leaders to conclude it would have no impact on the course of WWI. But months later a second form of the virus swept around the world, far more lethal than the first. And still another wave claimed lives months after that, with the full pandemic persisting for eighteen to twenty-four months in most parts of the world.

Some political leaders appear to think that a single mobilization will be sufficient. They are wrong. If H5N1 manages to mutate into a highly transmissible form, the impact of the pandemic will go far beyond hospitals, morgues and clinics. Grocery and retail shelves will swiftly empty. Michael Osterholm pointed out in the July/August issue of Foreign Affairs that the entire just-in-time delivery system that is now the cornerstone of our globalized economy could collapse. Financial analysts for BMO Nesbitt Burns think a months-long pandemic could actually undermine the entire Chinese economy, and European and North American companies that rely on Chinese manufacturing. Literally, a primary responsibility of government at all levels will be provision of food.

The Global Health Program has been surprised to learn that few of the world’s major voluntary organizations, such as the Red Cross or United Way, have developed pandemic response plans. Yet the American people will logically expect volunteers to help handle the ailing, dying and dead, as the sheer numbers will far exceed anything organized medicine can handle. Further, it is probable that pharmaceutical delivery for all types of medicines will break down in a prolonged pandemic, rendering diabetics, heart patients, people with HIV and a host of other chronic ailments in desperate need of their drugs.

Voluntary agencies could have a vital role to play, but are not now individually prepared, nor coordinated into any local or national plans.

To get an idea of the scale of need, New York City’s health department employed computer software called Flu Surge. They assumed that a strain of flu hit New York that was capable of killing 0.6% of those infected, at an attack rate of 15-25%. Flu Surge computed that New York would have:

  • Total infected: 1.2 million—2.8 million people
  • Outpatient visits: 485,000—1.2 million
  • Hospitalizations: 6,000—280,000
  • Deaths: 12,000—114,000

If New York authorities cleared all other patients suffering non-life threatening ailments out of the hospitals, there would only be beds for about 28,000 people. Assuming there would not be an effective vaccine immediately available, and prolonged use of Tamiflu would prompt drug resistance in the virus, health care workers could, themselves, be expected to fall ill and perish.

Also protracted is the H5N1 infection in bird populations. As the geography of bird infection expands, the opportunity for H5N1 to infect mammals, and eventually humans, also expands. Today our eyes are on Indonesia, but two years from now H5N1 might make its critical mutation in Lima, Johannesburg or Los Angeles. As the virus becomes endemic to a broader range of bird species, spanning a wider swath of the globe, the potential rises. This means that political leaders need to recognize that the threat is here to stay for a long haul.

Political leaders should, therefore, think carefully before passing sweeping legislation, calling out the Army or vetoing initiatives. It is important to separate plans by timetables: Measures we can take to handle pandemic flu if it emerges in the next six months are limited and bleak, but wise investments and strong science could well bolster the public health armamentarium considerably over the next five years.

Short term:

  • While it is true that the world needs more Tamiflu, we should be mindful of its limitations. It must be taken within the first thirty-six hours of infection for optimal results—few people realize they have flu and seek physician care that quickly. Distribution systems must be in place nationwide that can get ailing people their drugs, FAST, whether or not they have health insurance, a personal physician, or access to a nearby clinic.
  • It is essential that plans include finding ways to limit improper use of Tamiflu. If people abuse the drug now, taking it frivolously, or prophylax themselves with it for long periods of time in Asia, the likelihood of influenza acquiring resistance will rise. Further, limited supplies require limited use.
  • If Tamiflu is really so darned important, why have we not resorted to compulsory licensing, forcing Roche to yield production to rival manufacturers, patent or no patent? Are there not options, perhaps less severe in nature, that can be considered to bolster production? Is it just that the U.S. could create a $3.1 billion fund to buy Tamiflu at top dollar prices, ensuring that the entire production capacity of the drug will end up in America, at the expense of poorer nations worldwide? Surely the diplomatic consequences of such a specter are sufficiently odious to warrant some creative thinking.
  • Virtually no city or state in the U.S. has a bona fide pandemic preparedness and response plan. They should.
  • The U.S. should negotiate clear pandemic understandings with its neighbors, Canada and Mexico, ensuring that borders will not be closed, and diplomatic relations between the countries will be well maintained, despite likely differences in access to treatments and vaccines.
  • Most masks, latex gloves and syringes are no longer made in the USA. Many antibiotics and critical medicines are also foreign-made. Indeed, Tamiflu and much of the traditional U.S. vaccine supply are made overseas. Any federal flu plan must consider how such supplies can be stockpiled and/or maintained in a pandemic.
  • The USDA should have a clear poultry surveillance and response system in place. While such capacities exist on paper, the recent spread of BSE (“Mad Cow Disease”) to the U.S. has left some observers anxious. Stiff penalties should be in place for punishing any U.S. poultry company that delays informing authorities of ailing chickens, ducks and other birds.
  • There is currently no clear mechanism in place for monitoring flu infections in American zoos. Zoos are generally left to their own devices and word of honor. But West Nile Virus was spotted in the Bronx Zoo in 1999, and the Jakarta zoo experience offers a cautionary tale. Should zoo surveillance for H5N1 in the U.S. really be a voluntary enterprise?

Longer term:

We need a saliva-based rapid assay for H5N1 infection. If there is to be any hope of limiting spread of the virus, it must be possible to tell who is infected before they become so ill that they are bed-ridden. It is, after all, during that phase of early infection when the virus is spread by people who are shedding germs, but feel well enough to go to work, school, to the movies and so on. If Congress is going to spend billions on flu preparedness, a relatively small chunk of those dollars ought to offer incentive to the biotech industry for saliva-based assays, and field testing of their accuracy in Asia.

Some drug companies and small biotech firms are now working on innovative flu vaccines. None of them are likely to be on line in the short term, but it is conceivable that one or two such products will come to the FDA for approval within three to five years. Congress should provide the FDA with funds allowing them to work now on systems for reaching rapid, yet safe, approval of such products when they are developed. In addition, the FDA should reconsider current regulations that require repeated Phase III clinical trials for already-approved vaccines that have been bolstered with routine adjuvants.

The US government must stop avoiding the market failures in the pharmaceutical industry. If supply follows demand, why is it that the demand for 6 billion vaccine doses in rapid fashion does not yield supply? Obviously, this is a complicated question, but Congress has long avoided delving for answers. Even the multi-billion dollar Bio Shield program has not provided sufficient incentive for the industry: What, short of giant pots of gold, can prompt engagement by the industry in the great killer diseases of our time? Why are patriotism and social duty not incentives in this industry? What non-monetary system might provoke innovation and production?

Though investments have been made recently in improving the capacities of WHO and the world’s flu laboratories, they are woeful. A year ago the entire WHO flu branch was 5 people: today it is a whopping twelve. That is ridiculous. The laboratories vary widely in their funding, technical quality, safety, and political transparency. Some things can be solved with quick money, but others are closely tied to longer term issues such as medical education, public health infrastructure, political cooperation, patent laws, and social commitment. The U.S. should be working closely, and over the long haul, with the “early warning” nations where flu typically emerges: China, Hong Kong, Thailand, Vietnam, Laos, Cambodia and Indonesia. One proposal that merits scrutiny is the Pearl River Delta Laboratory—a joint China/U.S. concept—that would place a state-of-the-art laboratory squarely in the ecology that most often spawns influenza. (This is the brainchild of Columbia University’s Dr. Ian Lipkin.)

Also looking forward, nations worldwide must reappraise their animal husbandry and slaughter practices, identifying ways to limit livestock infection and prevent transmission to people.

The Asian flyway for migratory birds must be restored if, in the future, there can ever be a time when the threat of bird flu transmission to human beings will be seriously reduced. The migrating birds must be able to safely land in isolated, preserved streams and lakes, far from livestock and human beings.

A Final Thought

Recently San Francisco’s Mayor Newsome was asked what his city would do if it were hit by a Richter Eight earthquake. With candor refreshing for an American politician Newsome looked into the camera and told San Franciscans that for the first seventy-two hours, “You’re on your own.”

A flu pandemic ought not leave the citizens of the world on their own, each to survive by their own wits.

In America in 2005 we have lost a great deal of the sense of community that united neighbors and extended families in 1918. Few Americans really know their neighbors, live near relatives, or have a clear sense of belonging to a community. Many watched the horrors of New Orleans and wondered, “If that were me, laying in a nursing home or screaming from a roof top, would anybody hear my cry?”

Political leaders need to be able to say to America that some problems are larger than anything Government can handle. The US Marine Corps will not be able to swoop into Chicago in a pandemic and get insulin to house-quarantined diabetics, help frightened senior citizens to get food, or bring water to the ailing who lay on cots in school auditoriums. America must help America: neighbors must help neighbors.

And in a global sense, we are the richest, most powerful kid on the block. America can be loved for its efforts to help its neighbors in a pandemic, or it can be despised for hoarding all the solutions, all the technical tools, all the vaccines, all the medicines. It’s our choice.

 

President Bush’s Comments on Avian Flu

(Excerpted from White House News Conference October 4, 2005)

Q Mr. President, you’ve been thinking a lot about pandemic flu and the risks in the United States if that should occur. I was wondering, Secretary Leavitt has said that first responders in the states and local governments are not prepared for something like that. To what extent are you concerned about that after Katrina and Rita? And is that one of the reasons you’re interested in the idea of using defense assets to respond to something as broad and long-lasting as a flu might be?

THE PRESIDENT: Yes. Thank you for the question. I am concerned about avian flu. I am concerned about what an avian flu outbreak could mean for the United States and the world. I am—I have thought through the scenarios of what an avian flu outbreak could mean. I tried to get a better handle on what the decision-making process would be by reading Mr. Barry’s book on the influenza outbreak in 1918. I would recommend it.

The policy decisions for a President in dealing with an avian flu outbreak are difficult. One example: If we had an outbreak somewhere in the United States, do we not then quarantine that part of the country, and how do you then enforce a quarantine? When—it’s one thing to shut down airplanes; it’s another thing to prevent people from coming in to get exposed to the avian flu. And who best to be able to effect a quarantine? One option is the use of a military that’s able to plan and move.

And so that’s why I put it on the table. I think it’s an important debate for Congress to have. I noticed the other day, evidently, some governors didn’t like it. I understand that. I was the commander-in-chief of the National Guard, and proudly so, and, frankly, I didn’t want the President telling me how to be the commander-in-chief of the Texas Guard. But Congress needs to take a look at circumstances that may need to vest the capacity of the President to move beyond that debate. And one such catastrophe, or one such challenge could be an avian flu outbreak.

Secondly—wait a minute, this is an important subject. Secondly, during my meetings at the United Nations, not only did I speak about it publicly, I spoke about it privately to as many leaders as I could find, about the need for there to be awareness, one, of the issue; and, two, reporting, rapid reporting to WHO, so that we can deal with a potential pandemic. The reporting needs to be not only on the birds that have fallen ill, but also on tracing the capacity of the virus to go from bird to person, to person. That’s when it gets dangerous, when it goes bird-person-person. And we need to know on a real-time basis as quickly as possible, the facts, so that the scientific community, the world scientific community can analyze the facts and begin to deal with it.

Obviously, the best way to deal with a pandemic is to isolate it and keep it isolated in the region in which it begins. As you know, there’s been a lot of reporting of different flocks that have fallen ill with the H5N1 virus. And we’ve also got some cases of the virus being transmitted to person, and we’re watching very carefully.

Thirdly, the development of a vaccine—I’ve spent time with Tony Fauci on the subject. Obviously, it would be helpful if we had a breakthrough in the capacity to develop a vaccine that would enable us to feel comfortable here at home that not only would first responders be able to be vaccinated, but as many Americans as possible, and people around the world. But, unfortunately, there is a—we’re just not that far down the manufacturing process. And there’s a spray, as you know, that can maybe help arrest the spread of the disease, which is in relatively limited supply.

So one of the issues is how do we encourage the manufacturing capacity of the country, and maybe the world, to be prepared to deal with the outbreak of a pandemic. In other words, can we surge enough production to be able to help deal with the issue?

I take this issue very seriously, and I appreciate you bringing it to our attention. The people of the country ought to rest assured that we’re doing everything we can: We’re watching it, we’re careful, we’re in communications with the world. I’m not predicting an outbreak; I’m just suggesting to you that we better be thinking about it. And we are. And we’re more than thinking about it; we’re trying to put plans in place, and one of the plans—back to where your original question came—was, if we need to take some significant action, how best to do so. And I think the President ought to have all options on the table to understand what the consequences are, but—all assets on the table—not options—assets on the table to be able to deal with something this significant.

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