Announcement

**Theresa42** · April 20, 2007, 08:14 PM

Re: Osterholm & Gellin - BF Still a Threat?

Is The Bird Flu Threat Still Real and Are We Prepared?

[Rush Transcript; Federal News Service]

Speakers: Dr. Bruce Gellin, Director, National Vaccine Program Office, Office of Public Health and Science, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Dr. Michael Osterholm, Professor, University Of Minnesota's School of Public Health

Moderator: Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations

April 12, 2007, Council on Foreign Relations

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LAURIE GARRETT: If everybody could please get seated. We're always a stickler on time here at the Council on Foreign Relations. We like to start on time and end on time. My name is Laurie Garrett. I'm the senior fellow for global health here at the council, and I welcome you here on this dingy, difficult weather day, and I hope that you'll enjoy what we're going to deal with here today. We are being webcast so your comments in our question-and-answer period we would ask that you consider that there's an audience beyond this room in your remarks.

And I'll just remind you that we want you to turn your cell phones off, your Blackberries, your T-Mobile trios, whatever they may be -- anything that makes noise please turn it off. And also that today, unlike many other council sessions, we're entirely on the record, so anything goes. And just keep that in mind with your questions as well please, and we will ask that you not pontificate and that you actually ask a question. It's a unique concept.

With me today for our discussion of Pandemic Influenza -- the threat, risk assessment, are we prepared, what are we doing about it -- are the two best people I can think of to have sitting here, Michael Osterholm on my immediate left -- your right -- is with the University of Minnesota. Many of you may have seen his two pieces in Foreign Affairs, both of which are outside.

One was in 2005 saying are we prepared, and the second was just this last issue, saying we're unprepared. And Mike has been involved in infectious disease work and national readiness for all manner of bioterrorism and infectious disease threats for many, many years and playing a stellar role in that. He currently is the director of the Center for Infectious Disease Research and Policy at the University of Minnesota. And I guess I could put in a commercial and just say they run a wonderful website called CIDRAP -- C-I-D-R-A-P -- if you like being kept abreast of flu news.

And on his left is Dr. Bruce Gellin. Bruce really is the point person on this issue in the administration. He's in HHS -- the Department of Health and Human Services -- where he runs the National Vaccine Program office, and is the key advisor to the secretary of Health and Human Services on all issues that we're going to be talking about today, and a broader range of vaccine issues in the federal government. So I just can't imagine two better individuals for us to turn to.

Let me just start off by saying that we had a meeting 17 months ago here. The turnout was about five times what we see in the room here today, and I think that is indicative of a general shift in the level of concern that we saw in the general public 17 months ago compared to what we see today, and in the amount of press coverage and the amount of attention. Seventeen -- but what's happened in that 17 months?

Well, we had a mutational event at Lake Qinghai, China that resulted in a far broader range of species that could be affected by the virus and rapid spread from northern China into Siberia, over into Europe and Middle East and northern Africa. That had started already when we convened 17 months ago, but by the end of 2005 with still 13 countries that had been affected in either animals or human beings with the H5N1 form of influenza that we're worried about -- the avian flu. And a total of 98 human cases had been identified since 2003 -- 43 of them had been fatal. We were seeing the beginning of a kind of international mobilization.

Now, with far less international interest in the general public -- with Dr. Osterholm being labeled "Chicken Little" by The Weekly Standard, 56 countries have had H5N1 in their borders -- 193 additional human cases for a total of 291, and 129 additional human deaths for a total of 172. Passage of the National Pandemic Influenza Act of 2006 put $3.8 billion U.S. on the line, and in FY '07 another $2.3 billion. And the mortality rate among those infected with H5N1 has jumped from what had been 55 percent to, in the last 12 months, a 70 percent mortality rate.

So are you Chicken Little, Dr. Osterholm?

MICHAEL T. OSTERHOLM: First of all, it would depend on who's asking the question; with my kids maybe a different issue. One has to take a step back and divorce themselves from the immediate issue and headlines to realize that pandemics of influenza date back to antiquity. Modern history, i.e. since the 1500s, we have more description of them, but basically Hippocrates wrote about what was a classic pandemic of influenza. Influenza pandemics are a very expected and a very real part of Mother Nature. The idea that the bird, which has been around for about 150 million years -- the chicken only 100 million years -- somewhere in that process developed this virus infection called influenza, and periodically that virus, which is largely an avian virus, spins out through one of several mechanisms to be -- basically become, a human influenza virus. When that occurs a pandemic occurs.

There have been 10 pandemics in the last 300 years. There'll be more pandemics in the future. What we don't know is which strain will cause the pandemic. It may be H5N1, it may not be. If it is H5N1, there's reasons to believe it could be very severe. Another pandemic strain could come out of nowhere. Remember, in 1918 there wasn't what you would call pre-pandemic warning. In fact, the spring wave of the 1918 pandemic was quite mild, only then in the fall to cause the damage that it did. So we could have something very mild come out of nowhere.

I think the key piece to this today is that there will be more pandemics. Like earthquakes, hurricanes and tsunamis, they occur. So don't feel comfortable that this a Y2K knockoff -- that in fact if it didn't happen by now it's not going to happen. It's going to happen. The second thing that I think that is a misconception which is very important is that we are more vulnerable today I believe as a world to serious disruption and serious outcomes from a pandemic than we have been at any other time in history.

The reason for that is because of modern technology. It's because of the global just-in-time economy. In previous pandemics, people were already used to living in subsistent existences. So whether they counted on their food supply to be there or they counted on having no real confidence in medical care, that was all there.

Today, we are in a world where many of us expect to have all the modern conveniences. Yet today, 80 percent of all the drugs we use in this country come from offshore. The supply chains are so thin that in fact I believe with even a moderate pandemic -- you don't need to conjure up a 1918-like pandemic -- we will see major disruptions in things.

Look at the pet food scare recently. The idea that basically -- I won't call it a scare, it's a serious situation -- we're importing that much wheat from China to feed our pets -- it gives you an indication of the global just-in-time economy. So I would say from a Chicken Little standpoint, (A), a pandemic's going to happen, (B), today overlaid on this modern technology global just-in-time economy the implications of a pandemic today could be much more far-reaching than they were in 1968, '57, 1918, et cetera. So that's why we have to be prepared.

GARRETT: You wrote in Foreign Affairs, "In some ways, a fog of confusion has settled over these issues. Like soldiers in battle, policy makers and planners in the private sector are overwhelmed." What did you mean by that?

OSTERHOLM: When you start understanding the implications of a pandemic and what it could do today, you almost want to throw up your hands and say, "There is nothing to do. We can't do anything." And, in fact, it's interesting -- a little over a year ago I did an hour-long segment on this on Oprah, and needless to say over the next several days my email at the University of Minnesota posed some real challenges as I received many, many, many, many emails. And it was very interesting because they were divided in two camps. It was the same ugly face -- same message -- same everything on the show, but about half the emails came in and said, "You know, Dr. Osterholm, you know, people like you shouldn't be allowed to be in public. The university should fire you."

In fact, one went so far as to suggest I shouldn't be alive for scaring the hell out of people needlessly -- that this was wrong -- that it was not going to happen -- that basically this was just scare mongering. The other half over here were in the camp of saying, "You know, you're like everybody else out there in the government or every place else. You're covering up. Just tell us when we're going to die. Just be honest with us and tell us when we're going to die."

There was almost nothing in between, and that's a normal human reaction today when we are confronted with something so large and so complicated, we just tend to want to go to either one because if you think we're all going die, there's nothing to do. If you think it's not going to happen, there's nothing to do. It's where you're in the middle, that's a hard place.

That's where the fog comes in, because if you look at the fog of war, which is a well-recognized concept, we don't really understand our enemy. We don't know what it will be, we don't know what its intent is or what its capabilities are. We're not sure of our own capabilities, what we can do or can't do. When you add that all together, I think there are many lessons here.

So what I'm really addressing today are what are those things that, if it's a pandemic of influenza of even a moderate hit -- a SARS-like hit on the world that hits many communities at the same time, what would it really do to us? What are the implications? We have heard from the oil refineries. "If we lose 30 percent of our workers, we can't operate because "we have a-just-in-time, a-just-enough, employee system."

We've heard from the electrical grid system, where it already is very stretched. It's not just the people who work there every day, but it's the matter of many of the transformers, which come from locations outside the United States. Again, many/most of our transformers in this country come from outside the U.S. It's this global just-in-time economy issue, and it's that part that is the fog. When you get to that point where everybody counts on Internet. "Well, we just -- we'll work from home." Well, first of all, you can't make steel from home, you basically can't guard prisoners from home; and in addition to that, you're counting on the Internet when the Internet backbone people tell us that it's so razor-thin today with capacity, and that last mile is so challenged, we may or may not have Internet.

That's where the fog comes in. What we want to have are plans where we can plan, where we can do things. That works for natural disasters because when Katrina hit (and as crazy as things were), 47 states could bring all the resources they had to Katrina and try to help out.

When pandemics of influenza hit, every town, every city, every county, every state, every country's going to be in the soup at the same time. There won't be any reserve going anywhere, and that's the part of -- we're not prepared to deal with that yet.

GARRETT: Bruce, what's your threat assessment today compared to a year- and-a-half ago, and this notion of the fog of war? You're in the middle of it. How do you see that?

BRUCE GELLIN: Well, the threat assessment -- I mean, it's interesting because the World Health Organization five years ago put together a framework, and you often find yourself walking through an airport and you hear some announcements that Homeland Security says today's threat is orange. I don't -- I'm not quite sure what that means. You never know what to do with that information. But I'm not sure how many people are aware that we currently are living in a pandemic alert. That's the title of what this stage is for the World Health Organization.

It's at Level Three of a level -- of a series of six, and there's no guarantee that -- when we've been there for two years, but that these go sequentially over time. In fact, that is the concern that everyone has in the public health sphere globally when you hear about a cluster because the question is when there's this -- we know that there have been a series of cases -- and there continue to be this drumbeat of cases really around the world, just in the past several weeks in Egypt and Laos and China and other places when people are exposed to sick birds.

What we're worried about is that when the virus picks up the ability to do what regular flu does, and rapidly transmit among people, then you have a pandemic. Therefore, every time there's a case or a little cluster, that's what triggers these large investigations to figure out, "Is this the one? Is this the one that has triggered some new event?"

So I think that your comment before about this is suddenly falling out of the eye of the public, I think that's fallen out of the idea of the media because there's not that much that's new. It's there, the threat is the same. The virus, as he's mentioned, continues to evolve. As it gets into birds, it's going to get into more and more people and every one of these -- is an -- every one of these opportunities to -- among different species is an opportunity to -- for the virus to then pick up the mutations that it may need to trigger a pandemic.

GARRETT: But there is news in the sense that we now know a lot more virology -- we know a lot more about the science of influenza today than we did 17 months ago. And partly it's because of concern and additional funding through the National Institutes of Health and other like institutes elsewhere in the world. Partly, it's just that the technology and the ability to crack a lot of information out if the virus is there. There was a study recently published that showed that the 1918 virus, when injected into -- or when monkeys were exposed, caused symptom within 24 hours, death within eight days, and that it caused a complete disregulation of the entire immune system.

We now know through a specific mechanism, we've now seen that the virus has evolved radically. There's two distinct trees now of H5N1 viruses with sub-limbs, and most of that evolution has been quite recent. And we now have the University of California's study that shows that the -- almost all the new strains are coming out of one place, Guanjo, Guangdong Province, China with the duplication being that there are specific events going on in the ecology in that place that are contributing to this mutation cycle.

So all of that seems very worrying, especially when we add to it some indication that two amino acid changes were the key to turning the 1918 flu from a benign virus for our species to a rapidly transmissible virus for our species. You know, that's just a couple of point mutations. Ouch. That's scary. It's not like the virus has to go through some big, radical change.

GELLIN: I think what's new there is the science that's examined the phenomenon in the past. As Michael said, there have been ten pandemics in the last 300 years. All of what you said is predictable and we knew that every one of those things would happen, and in the same way that we have to get a new vaccine for flu every year, we're now seeing that with this continued evolution of the H5N1, which makes the vaccine challenge phenomenal because we end up having to chase each strain because we don't know which one or ones like it might the be the one to trigger a pandemic. So we've actually gone now into trying to develop vaccines at least in small lots to be able to make sure we understand the technology to be ready for this array of them, not knowing if it's any one of those or some other one.

GARRETT: When we announced recently that we bought a bunch of vaccine -- H5N1 --

GELLIN: (Cross talk.) We don't buy vaccine. We actually -- we actually ordered companies and tell them what we --

GARRETT: But what's -- why? We know the virus is going to mutate, why are we buying H5N1 that's against -- a vaccine against the currently circulating spread?

GELLIN: In the hope that it gives you some protection while you're retooling and making a vaccine of the pandemic.

GARRETT: Okay.

GELLIN: What we're -- we've spent a lot of money, and you mentioned the budget that the president put forward. He asked for over $7 billion. The largest chunk of that was for vaccine development and to really -- to turn around the vaccine industry.

So we've been working with the industry. You know, these vaccines are currently all made in chicken eggs. We have to have something that's a little bit more resilient than that, that's got more surge capacity and we're moving to transform that industry. But even then, we need subsequent generation vaccines to be able to have vaccines made faster. So what we're doing now is to make sure that we know how to make a vaccine based on current technology to have something in the pipeline and ready to go that might provide some protection. But you're right. We'd never before all this stuff, would have contemplated stockpiling a pandemic vaccine.

GARRETT: So for all the talk we hear, the chatter of this company and that company, putting out a press release saying, "Flu vaccine from us," is this getting us anywhere? Is there anything out there that makes me safer today than I was 17 months ago?

GELLIN: I think the only thing that makes you safer is the knowledge that there's so many people making so many investments to try to move things along. There's a lot of interesting technology, there's a lot of promising technology.

Today a lot of it is in press releases. We have to be a little bit careful about that. But the science is improving and a lot of what's out there is promising. It's not quite there yet, and we need to understand a lot more about it before we're going to start buying a lot of it. But I think it's going in the right direction and there are many, many people trying to crack this nut.

GARRETT: You were itching to --

OSTERHOLM: Well, no, I think that this is just, again, a perspective issue and I have to say I think Bruce has been a real international leader in trying to move us forward. Our government has done more, really, than any other government in the world. But it's been like trying to fill Lake Superior with a garden hose. Basically, when you think about it, it's not just a function of new discoveries. It's production capacity. It's timely production capacity. We're making a 1950s vaccine in just a little bit fancier way. We don't have the capacity to make vaccine in a timely way for the vast majority of the developed world; let alone the entire world.

So the point being is that we need a sea change, and it's not going to come in a couple billion dollars here and a couple billion dollars there. When you think of the threats to the world, not just in terms of death and illness, but in terms of economic stability -- in terms of short, intermediate and long-term economic impacts, I can't think of anything bigger than this.

You know, having been involved with terrorism, having been involved, Laurie, in those early days of HIV/AIDS, having been involved with any number of emerging areas, -- you can put them all together in one bucket and they don't equal the potential for what this can and will do. I likely believe it's the case. So I think that we really have our priorities out of whack financially, whether we believe the enemy is from within or from without, if we believe it's chaos, it's terrorism, it's whatever, we ought to be putting a much greater emphasis in a timely way. Even if we continue this approach and we continue to put the money in that's been committed, we are years and years off from having a vaccine that could be available in a timely way for this country, let alone the vast majority of the world.

Recently, we've heard about Indonesia --

GARRETT: I was just about to get to that because in February, Indonesia announced that all the strains of H5N1 emerging in Indonesia were going to be licensed to one company -- Baxter, for Baxter to make a vaccines, and no one else could have their hands on these strains. And of course for scientists -- for the whole notion of the world trying to monitor what's going on with the virus, this seemed an abhorrent idea.

Some very intense negotiations have been taking place at WHO, and so on, and the Indonesians seem to be arguing -- and Bruce, I'd like to know how you chime in on this -- but they seem to be arguing, "Look, you guys have no intention of making a product that will help Indonesians," "You're going to make a product for Americans," "You're going to make a product for the rich world, so why should we cooperate?" "What's in it for us?" And we'd previously seen some of the same moaning out of China, with certain Chinese groups holding onto viruses and not sharing them with the world community.

What's your read, and how do we get past this -- and what's, what can we say to the developing world community that runs in any way contrary to what Indonesia is saying?

GELLIN: The current -- let me back up a little bit. The system that the World Health Organization uses now for seasonal vaccine is the global surveillance system they've used for 50 years. And that's been -- where viruses are isolated in different parts of the world, and the assessment is made, and the ones that are turned into next year's vaccine -- which is why you always hear about things with strange names on them, because that's where these originated. And that has been the system in place for a long time.

Now we have the situation where viruses pop up in other places. And now a country like Indonesia says, "Wait a second, this is our intellectual property. We're going to take advantage of the only lever we have." I do need to correct one fact -- because we've spent a lot of time talking with the companies about this as well -- and despite what's in the press, the companies, across-the-board, are trying to work with the World Health Organization and don't want to take a virus from a country because that would then get them down a road where every country, every province, every everything is going to say, "Well, how about mine? Make my flavor." So it's -- it's a -- that's a pathway -- actually, if the companies go down that route, where there's -- it's going to splinter the entire industry and nobody's going to get anywhere.

What is going on though, is that Indonesia has decided to withhold this "sharing" into the World Health Organization. That's a big problem because of what we just talked about as far as just me making an assessment of 'is the virus changing.' I'd mentioned before, every case needs to be examined and we need to figure our whether this virus has changed. We need to worry about it and retool and make a vaccine.

You gave numbers before about the current case counts that the World Health Organization of 291 cases and 170 some odd deaths. There are a dozen or so cases in Indonesia that Indonesia has identified, but have not been -- not been acknowledged by the World Health Organization because they haven't seen the virus. The virus has not been shipped, so just making that assessment, "if the virus is changing," is now impossible given that stance.

So as you mentioned, this is something that the World Health Organization is trying to get their arms around. It's clear that linked to this is the importance of access to vaccines. They put out a plan six months ago about a large program -- it's been poorly funded so far. The United States has put in only $10 million so far, to begin to help developing country manufacturers begin to make -- to make their own flu vaccine. But as Michael said, that's the garden hose in a large lake.

So there needs to be attention being paid to access, to ensure that there is more capacity and more access. I worry about the slippery slope of what this might mean, not just for flu, but for all of pubic health when there's intellectual property being tagged on wild viruses.

GARRETT: Yeah, I think that's a serious concern. We saw the same thing with SARS in the early stages.

GELLIN: And I think one of the things that's really critical here -- that people don't understand is, there's this focus and almost this altruistic concept of the developed world versus developing world. Yet today if you want to look at it from a strategic and tactical economic standpoint, the vast majority of the goods that you and I count on every year are coming from the developing world. So that if you want to look at those medicines, you want to look at medical supplies, you want to look at any number of things -- like you go through food supply sources, et cetera -- it's coming from the developing world.

What happens in Asia will have tremendous impacts on what happens to us. So it shouldn't be about just an altruistic concern that we want to take care of our brother in the developing world, it is about being strategic and tactically approaching the issue of our economy. And I don't see that concept at all -- it's almost foreign. And I think that that's where we have to start to hit home -- and the function of time is critical here. How much time do we have left? The pandemic might not be for five, 10 more years. I don't know when it's going to occur -- it could be tonight.

And so part of what's happening here is, how do you bring a view? You mentioned the issue of -- people are somewhat dead to this. I came up with a concept about six most ago called "pandemic fatigue," which I think we're in the middle of. We've been -- just take something as simple as Lexus-Nexus and the actual ascertainment of how much news coverage is being given to this. We are today -- in the business category and in the general news category -- at an all-time low in coverage of pandemic preparedness -- H5N1 or influenzae -- in Lexus-Nexus for the last 36 months. It's almost gone away. You can't sustain this ongoing concern about preparedness -- investment in preparedness, if that's the concept you have and that's what we're really at. And what we need to do is step-up our preparedness much, much more than we've ever done at a time when it's at an all-time low.

GARRETT: Well, I was speaking of time, I want to make sure there's time for the general group to ask questions, but there's two, I think, very important points I want to cover with you quickly beforehand, because they are so crucial.

A year-and-a-half ago, the whole strategy around preparedness at a national level, for our nation and for nations all over the world, focused very heavily on a particular drug called Tamiflu, or Oseltamivir, made by Hoffmann-La Roche. And this drug has been shown to shorten the length of flu illness if -- by about a day, if you take it within the first 36 hours after exposure. And the thinking is -- well, but perhaps if you know there is a circulating pandemic strain, or you may have been exposed by family members or at the job -- that you would go on Tamiflu for a period of time to protect yourself.

Many governments have purchased massive amounts. The United States -- we have enough for 30 percent of the American people, for a course of treatment. And many of the wealthy countries of the world are running basically in the 25 to 30 percent coverage in terms of the stockpile for their population. Notably, Russia has purchased enough for 95 percent of all Russians. They obviously must know something the rest of us don't.

But meanwhile, more and more words of caution are arising about Tamiflu. In particular, out of Japan -- where the Japanese think that some, I believe it's 46 teenagers, are thought to have committed suicide as a result of delusions suffered while under Tamiflu influence. And there is a widening scope of -- or it's 54, excuse me, 54 in Japan -- and a widening scope of evidence of the emergence of drug resistant strains of H5N1 and of other forms of flu.

So Bruce, in particular -- you're advising Secretary Leavitt, is Tamiflu still an essential piece of our armamentarium?

GELLIN: Well, I congratulate you that you can go a half an hour into a discussion -- that's the difference between now and 2005. Before, Tamiflu equaled "preparedness." And you had to go a long way to tell people that Tamiflu might be important. It might not work, but it's only one piece of a number of different things -- from vaccines, to community mitigation strategies, to international investments. But clearly this is a virus, and an antiviral could have a big effect against it.

At the same time, the sprinkling reports you hear about its effectiveness is very hard to gauge, because this is an aggregate of these case reports that have happened around the world -- and the plural of "anecdote" is not "data." So part of this is to have a better system to monitor what actually people are being given, to see what's working and not, because -- and as we saw in SARS, a lot of things got thrown at a lot of people -- and some of those were probably not good for them, let alone trying to help them.

GARRETT: Would you have your teenager take Tamiflu?

GELLIN: If my teenager had severe influenzae -- absolutely. I think the -- there's no question that this is a -- this is a potent antiviral drug, and in the right circumstances it could help. But I think that if it's the only possible thing that's life- saving, you need to look at that in the context of what -- of a potential adverse reaction that's really not that well understood.

I think that it's important to put cautionary notes out there, but I don't think that these case reports out of China would tell us that we need to shift gears right now. We need -- what we really need is to diversify the number of antiviral drugs that we have. We currently have only two, in one class, that would work. Tamiflu is made by one company. Rolenza is a -- is a similar drug made by a different company. But as we know from the field of antimicrobials, the more you use these things, the more likely you are to lose them. So it's not going to be long until resistance could develop that could take that off the table. So part of this is to have a better class, a better set of antivirals, at the same time. But you can't not buy this as an insurance policy.

OSTERHOLM: If I could just follow up. I think one of the things that's been very confusing here is -- people have tried to extrapolate the data on Tamiflu and Rolenza, from seasonal flu to pandemic flu.

H3N2, which is the current seasonal strain, is a very different virus that H5N1. They're both influenzae viruses, but they're very different. How they cause disease, the levels of virus in the body, which organs are impacted, et cetera. And I think we have to be very cautious about extrapolating those data.

Having said that, I have yet to see any compelling data that says that if I'm severely ill with H5N1 -- meaning I have several days into the course of my illness -- does Tamiflu work? It's just the data are not there. On the other hand, we have animal models, I think, which is very convincing that says that if you're on Tamiflu at the time you're exposed, you actually can prevent the infection in the animals.

What we haven't had the discussion on yet is really how do we take Tamiflu to the healthy out there who are critical infrastructure workers, people who we need to keep going in our businesses, to keep critical products coming to market, et cetera? And imagine the debate if there's a shortage, which there would be very quickly, of prophylaxis as preventative use versus treating sick people and having a healthy doctor get the drug or a healthy nurse before a dying patient. Yet, biologically, I would argue that the potential benefit could be much greater both from a true health outcome standpoint and from a societal infrastructure standpoint to use prophylaxis. So we have a lot of work to do yet.

I'm not sure of those numbers. I'd be interested to follow up on those numbers. We don't have 30 percent in this country right now.

GELLIN: But that's the target.

OSTERHOLM: And I think the other countries are targets, too.

GELLIN: Yeah. I mean, it's somewhat variable. In part, actually, we don't have ours because we don't have a budget for this year. And that's a part of our budget that until we have it, we can't buy it and that will complete the federal purchase for the stockpile.

But it was sized based on -- through the assumption of how many people would benefit from -- who might get sick. As Michael suggested, these are drugs that have -- they're indicated to use for prophylaxis as well. And when we start using these for different purposes, you would need a lot more. We need to have that discussion. We couldn't have it before because there wasn't enough around. The companies have increased their global capacity and that at least now allows us to think about how to use these drugs in the same way they're indicated for the season.

GARRETT: Let me -- before I go to the audience, my last question to you: Robert Webster's really the kingpin of influenza virologists. I think you'd be hard pressed to name anyone who knows more about influenza viruses about Robert Webster.

Recently at a conference of flu virologists, he said that the entire effort has failed. That "To me it seems that we've failed. It's a lack of knowledge and political will to get at the source of the virus. It's a general failure. I'm not pointing a finger at anyone. I've also failed. We as a whole have failed to understand the ecology of H5N1 well enough to control it."

OSTERHOLM: Yes. First of all, two things: I have a disclosure to make -- which I should have made at the beginning of my talk, which I didn't -- is I know less about influenza today than I did five years ago. And I would tell you, anyone who's in the influenza business that doesn't acknowledge that isn't being honest with you, because as much as we've learned, we've learned how little we really know, because it's challenged many of the dogmas that we've had about influenza. So I think one of the things that Rob is saying is that we thought we understood the ecology a lot better than we did and we don't.

But the second thing that's happening is that in 1968 -- the last pandemic we had -- China harvested about 12 million poultry a year. Last year they harvested over 15 billion. The world has changed dramatically. We have many more livestock animals, birds particularly, on the face of the earth to feed the growing population. With 6.5 billion people on the face of the earth, one of every nine people that's ever lived is here today.

And so from a food-stock standpoint, if you look at Asia in particular, the number of domestic birds -- it's estimated that 80 percent of Indonesian households have birds either in their house or in their backyard as just a function of their everyday food supply needs -- their protein. So we've so changed the potential for the ecology from that perspective and we hadn't really understood or considered that.

Think about a virus that 30 or 40 years ago would have burnt itself out in the sense that there wasn't replacement birds. There was just not enough of them there. Today it's basically genetically wet out there, because everyday that a billion birds are harvested somewhere in the world, another billion birds around the world are hatched.

GARRETT: We keep replacing them.

OSTERHOLM: We keep replacing them.

GARRETT: So the evolutionary process is being manipulated by human beings.

OSTERHOLM: Well, it's being substantially changed at least. And so I think the point is, what Rob is saying, is that no one understood the complexity of the avian population dynamics with humans -- both migratory wild birds as well as in particular, domestic birds. This is true.

Nobody had any idea. We always used to think that birds basically pooped out the virus -- it came out the south end. We now know that Mallard ducks cough it out and get it through the respiratory track in very large numbers. No one knew that until recently. And today, again, that plays a potentially important for moving it from location to location, farm to farm, et cetera.

So I think that what Rob is just acknowledging is the reality of this complex world. And I would think he's being a little hard on himself or others to say that we failed when we just had no idea what we were doing. And so in a sense, it's just a function of recognizing the difficulty of this whole situation and how complex it is.

GELLIN: And we can't forget -- these are essentially -- the reservoir for flu viruses are in birds. That's where they've always been. And now the whole world is fixated on H5N1. The rest of the world can hardly another virus, but there are 16 different H's out there. And I think the point is that while we're paying a lot of attention to this one, as we need to, Mike's comment before about these pandemics happen. They've happened before; they're going to happen again. It may be that this is a virus that for whatever reasons that we don't understand, doesn't have the ability to become a pandemic. But we know that these viruses do as a class and they're all over the place and there are reservoirs in birds.

So I think that all of -- the good part about all this is it's finally put this stuff above the fold. People have paid attention to the real threat of a pandemic and it's ratcheted up a lot of things that are not just H5 specific.

GARRETT: Well, before we go to the questions, I think that from our government we have a brief public service announcement. If I could show it.

(Video shown.)

GELLIN: Has anybody seen that or heard that on the radio? Well, so this is a problem of PSA land. Who knows what time they go. Three hundred television stations, 1,000 radio stations have that and they're playing them the way they play PSAs.

But I think the point is that there is a lot of information that people need to understand. Regularly I use my mother as a focus group, because she tells me a lot about flu that is not quite factual, but I think that she represents the way a lot of people get their information and what they're thinking about. And at least -- the web, at least, gives an opportunity to have people go and ask for -- and get some answers.

So this was really driven so people could have specific questions answered and go find them somewhere on this essentially government-wide website. So I think it also speaks to the importance of broad educational campaigns and the kinds of things Michael was talking about. This is not just a public health problem. This has got the potential for a global not only social, but economic catastrophe. Everybody's got a stake at this and everybody needs to know what the facts are.

OSTERHOLM: I hope your mother's not listening to this webcast.

GELLIN: She's not capable of watching a webcast, thank God. (Laughter.)

GARRETT: So we're going to open up for the Q&A now. And the first question is from Portugal from Tony Jenkins (sp) asking: Given that the first line of defense will be social distancing and that the N95 masks are not very effective at blocking anything as small as a virus, why have we not seen advances in producing better, cheap disposable masks? Is there anything that can be done to spur this field?

OSTERHOLM: Well, this is a classic example, again, of the current business model. I won't go into the premise of social distancing and so forth. I think that's still an issue of some discussion. But clearly, respiratory projection, as we know it -- either N95s, which are a type of tight face-fitting -- what some people call masks. We call them respirators that actually are there to really keep out even more potential virus particles from getting versus the surgical mask, which some would argue is quite effective. Others would say less effective.

But the bottom line is that the world is really, again, a supply world. There are several companies which own the large market share for the entire world that make an N95 mask. They've only done a limited amount of increase of their product production, because they have no guarantee down the road anybody's going to buy it.

And you know, today when you think about this -- and this is a non-economist, epidemiologist saying this, so I apologize in advance -- but you know, we criticize Department of Defense contractors that basically make things that cost $45 for a lug nut or $82 for a toilet seat. What we have to understand is that when they actually go in and contractually -- to come up with a contract with the federal government, they're coming up with -- if we're going to build 400 of these, we're going to amortize the entire cost earning we have to build the plant, to make those and to bring the plant back down again because we're not going to use it again once we make that. And so in a sense, things get exaggerated in costs when you realize that cost. There are many companies out there today that would do more to ramp up their ability to provide these kinds of things if they knew that if they built this plant that for 20 years it would get used -- not a one-time six-month or eight-month hit, where then after that we don't need it anymore -- because they can't amortize the cost of all the investment into doing that over the life of that entire plant.

And so we have no --

GARRETT: But do we even know -- Bruce -- (inaudible) -- do we even know what kind of mask works?

GELLIN: We don't know.

GARRETT: No.

GELLIN: I mean that's -- I think that we have to acknowledge that the science of how masks might protect is weak. But I think --

GARRETT: So if I'm a company and you're telling me to ramp up, so --

OSTERHOLM: I don't think that's the case. We know that N95s work. N95s work across a variety of different organisms, and flu is not anything special that way. I mean, frankly we know a lot about infectious agent transfer, whether it's a bacteria, whether it's a virus, whether it's particle-driven, whether it's aerosol -- we know a lot. I think the question is, how much would masks work? But N95s, I don't -- there's no debate that in the health care setting we've demonstrated for decades how effective they can be against similar particles. So I mean, ideally we could use masks.

But the message applies for both masks and respirators. It doesn't matter. We don't have a world economic model for a company altruistically to build all these plants with the hope that someday you might use it. And so if we're going to want it, we've got to buy it. And we have to buy it in a way that makes it financially logical for that company to invest in that. So when we continue to see major shortages in a lot of these supplies today, people will say, "Wait a minute. In a free, global market economy, shouldn't the -- you know, if we're asking for more mousetraps, they should build them." No. That's not going to happen. And that's been a poorly understood part of preparedness. That's -- just hasn't happened for that very economic reason.

GELLIN: But the issue -- the same issue you raise about the manufacturing capacity -- actually, it's true for the vaccine piece as well, in that you're building a massive capacity for the hundred-year storm, and that's it. So I think part of this is an opportunity for innovation, to think about -- I mean, when you use these masks you have to change them regularly. It's not like you just have one mask that you keep for the rest of your -- for the rest of the pandemic. You have to change them all the time. So the masks -- the quantity of masks that you might have to go through is enormous. So I think here is an opportunity to think about innovation and maybe we can bring about the next generation of masks -- a reusable, washable mask. You could potentially have a handful of them. But that's where we need to try to inspire some new technology.

GARRETT: Well, let me have a few from the audience.

Here in the front. And please identify yourself.

QUESTIONER: Hi, I'm Jessie Gruman from the Center for the Advancement of Health. Jessie Gruman -- hello?

GARRETT: Yeah. You're all right.

QUESTIONER: Jessie Gruman from the Center for the Advancement of Health. Earlier this year, HHS held their war games equivalent of a pandemic, and I wondered if you'd comment on how that went and what you learned.

GELLIN: Well, I guess I'm not sure specifically -- we do these a lot and in different settings. And so I guess -- and we learn a lot each time. So I guess if you're going to have something more specific you want to --

Q: It was the only one that I've seen recently that had lots of coverage in The New York Times. Probably happened in January.

GELLIN: It was the CDC's.

Q: CDC's. Okay.

GELLIN: Yeah, that was a CDC one held in November.

Q: Oh, okay.

GELLIN: Well, I wasn't there so I can't speak to that one.

OSTERHOLM: You know, we've been very involved with them. In fact, we have a program at the University of Minnesota -- we teach people how to do these. But again, you have to understand that if this were an event like a building that implodes -- explodes, a hurricane that hits, a tornado -- those are self-limiting events that we typically plan for. Those are the kinds of things you can.

I mean, with all due respect, what happened here in New York City on 9/11, as horrific and horrible as it was, in several hours it was over. The recovery was already able to begin. When a pandemic hits, it's going to unfold for weeks and weeks and weeks, and there are going to be so many unanticipated global issues that will come up where, for example, what do you do? Let me give you a case in point. You can't -- you can't drill this. You can't exercise this.

In 1968, the average time from a casket being made until it was in the ground was six months. Today it's less than four weeks. A growing number of our caskets are coming from China. Most of the parts that we use today to make caskets come from China. We're going to run out of caskets overnight -- literally we will in this country. Now the other part of that is, well, we'll just use crematorium space. Well, you know what? Crematorium space in this country is a just-in-time delivery system.

We learned from both Katrina and from the Indonesian tsunami that, from a psychological standpoint, what took people over the edge in both of those was not just the events as they unfolded, but it was watching the disrespectful and untimely manner in which we handled the dead bodies. And I would argue today that what will be a very major tipping point in our communities for how people perceive we're doing and the potential for what I call outright panic will be is if we don't handle, in a timely and respectful way, our dead. And today, we're less prepared to do that because we're so used to this just-in-time system, than they were in 1918.

GELLIN: Let me --

OSTERHOLM: Let me just finish up because then -- the point is, you can't war-game that; you can't tabletop that because it's an afternoon. And so what we need to do is both what we're doing -- and so, as I said, we teach this; we're very supportive of this -- at the same time, we've got to start thinking much bigger. You've got to think way down the road -- the three weeks, the five weeks, the eight weeks out piece -- and that's the part that's been lacking.

GELLIN: Let me get back to the heart of your question. The -- what they learned the most -- again, I wasn't there for that one, but what they learned the most was related to what Michael was talking about, was not about caskets but about what people perceive is going on and where -- and source of information. So my sense of the most important information that came out of this was communication, not just within the government or across the government but to people to let them know what was happening.

Related to that, we've actually had another -- that's why I asked you about which one of these exercises because we do them a lot -- and they're -- in fact they're designed to create chaos and to cause failure so you can really learn something from them. We've, over the past three or four months, had a series of these exercises around the country with local media to try to get a sense when a scenario's unraveling of what information that they want. So I think that's actually been among the most important things for us is to try to understand how the media is going to be looking at our perception, what kind of information they need, the access to the information, the access to trusted sources. And clearly related to that is the importance of clear communication. This little prop was just one way to get people to begin to answer some of their questions, but it's critical that -- in Michael's fog of war there's going to be a lot of confusion unless people know where to get the truth and how to know -- and know what's going on, what people are doing about the problem and where to get information for themselves -- that chaos will escalate.

OSTERHOLM: He's right.

GARRETT: Okay. Over here.

QUESTIONER: Joel Cohen, Rockefeller University and Columbia University. Thank you for coming to talk about this, and thank you for your presentations. And thanks to Laurie for her continued leadership in this area.

My question concerns the case fatality rate estimates. The numerator is the number of people who die; the denominator is the number of people infected. Could you give an assessment of the possibility that there are a large number of people, much larger than the present denominator, who have sub-clinical infections or who may have had flu infections that were not treated as H5N1? Is -- it looked like -- I mean, if there were a lot of people in the denominator whom we missed, that would lower the case fatality rate, but it would mean that the reservoir of potential sources of infection could be much larger. So it's not necessarily reassuring if you tell me that the case fatality rate could be much lower.

GARRETT: Right. Actually quite a lot of work has gone into this.

QUESTIONER: Could somebody tell me what the story is?

GELLIN: Well, part of the story is how difficult it is to do the studies to figure out what the denominator actually is. These serological studies, to go on and take blood from the population to find out if they've been exposed, are really quite difficult to do. In the same way that -- no mayor wants one of these going on in their town when somebody gets sick and they finally get -- either get better or die. They don't want any more attention being paid to this. So this has been a huge problem.

But you've asked the most important question. My understanding -- in the places where some of those background -- that background information has been looked for -- is that the -- that the fatality rate is actually quite high, that there are not a lot of sub-clinical illnesses. You would expect actually a lot of that illness in these poultry workers -- the people doing the culling. There's not a lot of it there. So it tells you that, for whatever reason, those people who get infected -- it may be that -- their proximity to the virus; it may be related to their own genetic makeup; it may be related to the amount of virus that they are actually exposed to -- when those people get sick, they do very, very poorly. But right now, the other thing it tells us is this virus is not terribly transmissible.

GARRETT: And the other thing that the epidemiology tells us that the majority of the people who get truly a horrible illness and fatality are under 30 years of age, which is -- was the case with the 1918 flu.

Let's take an -- in the back there.

QUESTIONER: John Train, Montrose Advisors. What is the shelf life of Tamiflu? And could it theoretically be applied repeatedly to people who are going to be exposed -- like health workers?

GELLIN: Right.

GARRETT: Bruce, you put work into it.

GELLIN: Sure. The shelf life of the drug on the package insert is five years. We know -- and the government actually has a program called the shelf life extension program because of the way it's being stored and we can monitor the temperature essentially from the factory and keeping it in perfect conditions, we have the ability to quote, "extend" that shelf life. We don't know how long it will be, but at least there's the potential to do that.

Interestingly, the drug itself seems to be quite stable over time. The capsule in which it's packaged may have less stability. So I think that where we're going to have to look over time -- but currently it's five years.

Your question about reapplying is several questions at once. If you get sick with influenza during the season this year and receive this drug, and you get sick next year, you can receive that drug again. I think the nuance behind your question -- is the one that Michael was talking about -- is the opportunity to provide prophylaxis -- if you're not sick, but to provide prolonged prophylaxis.

The package insert which means -- which indicates where there's significant experience and have taken that data to the FDA says it's safe to take that drug for a period of six weeks. Now, that raises the question of in the pandemic, if you were going to prophylac someone for a longer period of time, what would that mean? And I think we'd have to have more data to get a better understanding of that, but at least as far as that goes, we do have experience with six weeks worth of prophylaxis which would be one pill a day.

OSTERHOLM: I might add that there's a bit of confusion today, and I think that you're going to see some blowback on the issue. What Bruce just shared with you is absolutely correct on the shelf life extension issue. But that applies almost exclusively right now to the federal government purchase of that because the other individuals or groups buying this -- including state governments and private companies -- are not part of that program, and therefore their product is not being held under necessarily the same conditions, which right now the FDA does not have the ability to actually extend the shelf life on that.

So many companies that have bought Tamiflu will find themselves potentially -- and hopefully we can reconcile this before the five year period is up -- with five years worth of Tamiflu that's now outdated and not considered to be potentially effective -- even though I would argue it probably is and I would surely use it in the face of a pandemic without any hesitation.

GARRETT: And it will only be worse if you happen to be, say Vietnam or another tropical, hot climate trying to find a way to store for years on end. Indeed, I understand that Vietnam and Thailand are both requesting that they be able to dump their current stockpiles -- which they think are no longer any good -- and buy Tamiflu and looking for funding to do so.

We have a really interesting question off the webcast. And I'll probably massacre this gentlemen's name, which is Polish -- I will do my best -- Tony Schuczinski (sp) is an emergency preparedness coordinator. He says, "I work for a level one trauma center in a city of about 1 million people. I recently attended a Homeland Security pandemic training course. What I got out of the training was that we should not so much plan for a pandemic, but plan better for seasonal flu. Do you agree with that line of thought?"

GELLIN: Well, it's not either-or. I think that there's a need to prepare better for seasonal flu. We know that hospitals often get overloaded, and that's a separate question -- but I think that the point of preparing for pandemic is it's much more than the health sector, it's much more than emergency room, it's all society. Last year, Secretary Leavitt went around the country with governors and said -- really echoing what Michael said -- having learned the lessons from Katrina, which was a bad thing that happened in a fixed place over a fixed period of time, a pandemic is the inverse of that. It will be everywhere and it will be in many places and therefore every community needs to be prepared.

So I think that point of that is to, in your own communities, have an understanding of what's happening in your own communities, the degree to which there is a local plan, and the degree it's being practiced.

OSTERHOLM: You know I would just say I strongly disagree with that conclusion. Whoever shared that from Homeland Security I think is part of the problem that we have today in this country, in terms of planning for a pandemic.

Last year in this country, a person every minute, once every minute, 60 every hour, were diverted on their way to an emergency room that they desperately needed because that emergency room was so overfilled that it was determined that their status would be more compromised by going to that emergency room than diverting to one farther away. Today our health care system or really more appropriately called the disease care system in this country has been gnawed down to the bone and we're sucking calcium. We have no excess capacity in our health care system -- none, zero, zip. And we're already hurting. Now you overlay a pandemic and we have to come to the realization this health care system will not handle it.

First of all, when people say, well, this is, you know, the 21st century -- we'll have antibiotics. Today antibiotics are a just in time delivery product in many hospitals. We've seen an increase number of hospitals in this country get deliveries three times a day now for pharmaceutical and central supply products. We'll run out overnight. I worry about things like, as I said, insulin. Just how much insulin we'll have in this country -- again, much of it coming from offshore.

So what we have to do is plan not to integrate pandemic flu into our health care system, but, first of all, just figure out how the hell we're going to keep our health care system afloat for people who still have heart attacks, for people who still have cancer, for people who still are going to deliver babies, for people who are still in accidents, and how are we going to keep that going, knowing that there are going to be a lot of doctors and nurses that are either going to be sick, that are going to be home caring for their own family members, or that are going to be too afraid to come to work. And that's the part that we haven't thought about yet is we've got, I think, we're on parallel tracks.

Today, health care during a pandemic will be cheap. How expensive is it to provide good nursing care? That's what it's going to be. And so, if you don't plan for that now -- that's going to be like planning for Katrina where everybody's going to have a credit card voucher to go and get food after Katrina hits, but everybody forgot there was no electricity to run those credit cards on. That's what we're talking about.

So I think that that's the key message today is communities have to plan for a system that won't take much more to tip it over the top, but yet a system we need to maintain the best we can for those things and a system in addition for pandemic flu. Any community that's not thinking about that is going to be in big trouble very quickly.

GARRETT: Well, I was comforted when I looked to see who are PFO is -- our principal federal officer -- in the event on a flu pandemic for the Northeast corridor, 17 states -- it's a gentleman with the Transportation and Safety Administration.

One more question form the audience? Over here, Betsy?

Q (Off mike.) Actually, since we're at the Council on Foreign Relations, I'd be interested to know how other countries are doing in their planning, in terms of surveillance. Not once have we mentioned surveillance in this conversation, so I'd be interested in that.

As well as, you know, United States, if we can't get our infrastructure in place -- our preparedness plans in place -- how countries in Asia where it's likely this could emerge or, you know, less developed -- less strong countries are doing in that? And also, the relationship between the United States and our counterparts -- I know there's been a lot of work at APEC and (ASEAN ?), and how that's shaping up.

OSTERHOLM: You know, I spent 25 years in the trenches of surveillance at state public health and our group has done a lot looking at surveillance. And over the years, our general theme was how much we're missing out there because of all the inadequacies and diagnosis and so forth. And I have to tell you, I don't think that's the case today with this issue.

And part of it has to do with the electronic age. It's pretty **** hard to have anything happen in this world today that we don't pick it up somewhere on the Internet. Much of the chatter is wrong, much of it is incorrect, it's sensational, but there are very few times that we go back now and find things that happened months ago that would have occurred, I think, 20 years ago that we didn't know about.

And so I think given as Bruce very appropriately laid out, the vast majority of this disease is very severe disease. The serologic studies confirm that. We're not seeing a lot of this. Now, if that changed and we had a lot of milder illness, yeah, we might miss it. But we're not.

And so I think right now -- and I think SARS helped us -- SARS actually was a tipping point because SARS tipped people off to the power of the electronic word and the fact that today that the Internet is this incredibly powerful tool -- you can be in the most rural areas of the world and we can still find out about things. And we've had examples of that in Africa recently.

So I don't think we're missing a lot. I would have not said that a while back, but that again is again predicated on this more severe disease. If this should become a milder disease, then, I think, yeah, we could start missing it because people just wouldn't know what to report. But I'm confident that we're not missing a lot.

GELLIN: The companion piece of surveillance is the actual diagnosis. And Michael's right, I think the good part and the bad part is the electrons go pretty quickly. I think the problem is to ensure and that there's been both from United States and other governments have been investing in some of the laboratory capacity so that when some event happens somewhere, a local lab can make the call in a reliable way. Because you don't want it being made wrong either because it was right, because it was H5 and you called it something else, or the opposite. So I think there's -- that is where there's been a substantial amount of investment, there's still a long way to go.

There is a -- there have been a couple of these pledging conferences. A year-and-a-half ago, there was one in Beijing where the countries of the world got together and pledged almost $2 billion. There was a similar pledging conference in Africa last year. I think that cashing in on some of these pledges and turning those into programs is the challenge. But at least there is -- those pledges are out there. The U.S. has given a substantial -- has donated a substantial amount, not only to the World Health Organization and the FAO, the agricultural group, but also bilaterally with many countries. And as you suggested, we're members of as many clubs as we can be a part of, where there's some activity that's going to move these forward.

GARRETT: Well, we have a rigid rule here at the council. We always end on time. So I want to give each of you two minutes for your final comments so that we can, indeed, end on time.

Mike, why don't you start.

OSTERHOLM: Well, I'd like to again thank the council for having this event. We can use all the help we can get right now to keep people's interest in terms of moving forward in preparedness.

I think one of the things that we haven't talked about a lot -- but I know people in the audience represent, to a certain degree, this segment of the world -- is we've talked a lot about government, and we've talked a lot a little bit about business -- and the standpoint more about how they're going to basically respond to the current pandemic threats with drugs and vaccines.

But we haven't talked about the general basic business preparedness issue. And if there is anything that underlies, I think, our international security standpoint, it has to be considered this issue. And if you look at this, we're not preparing. I know of one company in the United States today that has their pandemic preparedness plan on their website -- that's it. And that's not a large company. Today, I have heard over and over again, for preparedness -- officials in companies who've said, "You know, this is being seen as the Y2K issue" -- and companies are basically moving on to other things.

So I think, from a standpoint of security -- from a standpoint of both economic security and I think just whole-world, the entire world security in general -- this has to be a much more front-and-center issue. And I don't see that happening. And I think the council is a place where that can happen. So again, I appreciate your attention tonight, but I think there's much more that all of us can do. And, I think, in paraphrasing the words of the great famous Ben Franklin, "We must hang together or we surely shall hang separately." And I worry one day there'll be a post-9/11-like commission that will look at pandemic flu and realized there were many, many, many opportunities to be better prepared and we didn't take them.

GARRETT: Bruce -- on that note.

GELLIN: Well, I think I have to applaud you and the audience for coming, because as you -- your premise here was that a lot of people think this problem has gone away. And I think it's important to recognize that it hasn't -- and everything about it keeps us up at night and worried that something might happen. That next shoe might drop, it might be going on right now, and we have to keep our guard up.

At the same time, we're often -- always asked the question of, "Are we prepared?" And I think that that is a continuum -- I think that we are clearly a lot better off than we were. We didn't get it all -- talking about some of the domestic issues, and getting -- and trying to understand where states are with this level -- with preparedness. But they've gone -- they've really come quite a long way. All states now have plans; they're all doing exercises. I would encourage you to find out in the place you live what's going on, and what they've learned from those, and what they're going to the do about it.

But I think that there has been -- there has been, at least within government -- both the federal government and the state governments, there has been a massive increase in attention being paid to this. Our fatigue is because we're doing so much work -- not because we're tired of doing it -- but I think we still have -- we still have quite a long way to go.

We have a lot -- there's been, as I mentioned, a request for over $7 billion just in the U.S. government, to do a number of things. As Michael suggested, that's just a portion of the global spending, and the spending that's not just the federal spending, but spending by all sectors of society to ensure that there is preparedness at all levels.

GARRETT: Well, I want to thank both of our speakers, Bruce Gellin and Michael Osterholm, for joining us. And all of you in the webcast zone, thank you for being here, and for those of you in the audience. Thank you very much.

(Applause.)

THIS IS A RUSH TRANSCRIPT.

Council on Foreign Relations

http://www.cfr.org/publication/13115/is_the_bird_flu_threat_still_real_and_are_we_prepared_rush_transcript_federal_news_service.html

The Council on Foreign Relations (CFR) is an independent, nonpartisan member organization, think tank, and publisher.

**gsgs** · April 21, 2007, 03:17 AM

Re: Osterholm & Gellin - BF Still a Threat?

most interesting for me was (AFAIR) that Russia has Tamiflu for 95% of population
(when did they decide to buy it ?) and that Osterholm recommends
prophylactic use of Tamiflu

**Snowy Owl** · April 21, 2007, 07:21 AM

Re: Osterholm & Gellin - BF Still a Threat?

Fragments of the Transcript

Originally posted by Theresa42 View Post

Is The Bird Flu Threat Still Real and Are We Prepared?

[Rush Transcript; Federal News Service]

Speakers: Dr. Bruce Gellin, Director, National Vaccine Program Office, Office of Public Health and Science, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Dr. Michael Osterholm, Professor, University Of Minnesota's School of Public Health

Moderator: Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations

April 12, 2007, Council on Foreign Relations

--------------------------------------------------------------------------

With me today for our discussion of Pandemic Influenza -- the threat, risk assessment, are we prepared, what are we doing about it -- are the two best people I can think of to have sitting here, Michael Osterholm on my immediate left -- your right -- is with the University of Minnesota. Many of you may have seen his two pieces in Foreign Affairs, both of which are outside.

One was in 2005 saying are we prepared, and the second was just this last issue, saying we're unprepared.

And Mike has been involved in infectious disease work and national readiness for all manner of bioterrorism and infectious disease threats for many, many years and playing a stellar role in that.

And on his left is Dr. Bruce Gellin. Bruce really is the point person on this issue in the administration. He's in HHS -- the Department of Health and Human Services -- where he runs the National Vaccine Program office, and is the key advisor to the secretary of Health and Human Services on all issues that we're going to be talking about today, and a broader range of vaccine issues in the federal government.

Let me just start off by saying that we had a meeting 17 months ago here.
....but what's happened in that 17 months?

Well, we had a mutational event at Lake Qinghai, China that resulted in a far broader range of species that could be affected by the virus and rapid spread from northern China into Siberia, over into Europe and Middle East and northern Africa.

That had started already when we convened 17 months ago, but by the end of 2005 with still 13 countries that had been affected in either animals or human beings with the H5N1 form of influenza that we're worried about -- the avian flu. And a total of 98 human cases had been identified since 2003 -- 43 of them had been fatal. We were seeing the beginning of a kind of international mobilization.

Now, with far less international interest in the general public -- with Dr. Osterholm being labeled "Chicken Little" by The Weekly Standard, 56 countries have had H5N1 in their borders -- 193 additional human cases for a total of 291, and 129 additional human deaths for a total of 172. Passage of the National Pandemic Influenza Act of 2006 put $3.8 billion U.S. on the line, and in FY '07 another $2.3 billion. And the mortality rate among those infected with H5N1 has jumped from what had been 55 percent to, in the last 12 months, a 70 percent mortality rate.

MICHAEL T. OSTERHOLM: First of all, it would depend on who's asking the question; with my kids maybe a different issue. One has to take a step back and divorce themselves from the immediate issue and headlines to realize that pandemics of influenza date back to antiquity. Modern history, i.e. since the 1500s, we have more description of them, but basically Hippocrates wrote about what was a classic pandemic of influenza. Influenza pandemics are a very expected and a very real part of Mother Nature. The idea that the bird, which has been around for about 150 million years -- the chicken only 100 million years -- somewhere in that process developed this virus infection called influenza, and periodically that virus, which is largely an avian virus, spins out through one of several mechanisms to be -- basically become, a human influenza virus. When that occurs a pandemic occurs.

There have been 10 pandemics in the last 300 years. There'll be more pandemics in the future. What we don't know is which strain will cause the pandemic. It may be H5N1, it may not be. If it is H5N1, there's reasons to believe it could be very severe. Another pandemic strain could come out of nowhere. Remember, in 1918 there wasn't what you would call pre-pandemic warning. In fact, the spring wave of the 1918 pandemic was quite mild, only then in the fall to cause the damage that it did. So we could have something very mild come out of nowhere.

I think the key piece to this today is that there will be more pandemics. Like earthquakes, hurricanes and tsunamis, they occur. So don't feel comfortable that this a Y2K knockoff -- that in fact if it didn't happen by now it's not going to happen. It's going to happen. The second thing that I think that is a misconception which is very important is that we are more vulnerable today I believe as a world to serious disruption and serious outcomes from a pandemic than we have been at any other time in history.
The reason for that is because of modern technology. It's because of the global just-in-time economy. In previous pandemics, people were already used to living in subsistent existences. So whether they counted on their food supply to be there or they counted on having no real confidence in medical care, that was all there.

Today, we are in a world where many of us expect to have all the modern conveniences. Yet today, 80 percent of all the drugs we use in this country come from offshore. The supply chains are so thin that in fact I believe with even a moderate pandemic -- you don't need to conjure up a 1918-like pandemic -- we will see major disruptions in things.

Look at the pet food scare recently. The idea that basically -- I won't call it a scare, it's a serious situation -- we're importing that much wheat from China to feed our pets -- it gives you an indication of the global just-in-time economy. So I would say from a Chicken Little standpoint, (A), a pandemic's going to happen, (B), today overlaid on this modern technology global just-in-time economy the implications of a pandemic today could be much more far-reaching than they were in 1968, '57, 1918, et cetera. So that's why we have to be prepared.

OSTERHOLM: When you start understanding the implications of a pandemic and what it could do today, you almost want to throw up your hands and say, "There is nothing to do. We can't do anything."

In fact, one went so far as to suggest I shouldn't be alive for scaring the hell out of people needlessly -- that this was wrong -- that it was not going to happen -- that basically this was just scare mongering. The other half over here were in the camp of saying, "You know, you're like everybody else out there in the government or every place else. You're covering up.

....When you get to that point where everybody counts on Internet. "Well, we just -- we'll work from home."

Well, first of all, you can't make steel from home, you basically can't guard prisoners from home; and in addition to that, you're counting on the Internet when the Internet backbone people tell us that it's so razor-thin today with capacity, and that last mile is so challenged, we may or may not have Internet.

When pandemics of influenza hit, every town, every city, every county, every state, every country's going to be in the soup at the same time. There won't be any reserve going anywhere, and that's the part of -- we're not prepared to deal with that yet.

GARRETT: Bruce, what's your threat assessment today compared to a year- and-a-half ago, and this notion of the fog of war? You're in the middle of it. How do you see that?

BRUCE GELLIN: Well, the threat assessment -- I mean, it's interesting because the World Health Organization five years ago put together a framework, and you often find yourself walking through an airport and you hear some announcements that Homeland Security says today's threat is orange. I don't -- I'm not quite sure what that means. You never know what to do with that information. But I'm not sure how many people are aware that we currently are living in a pandemic alert. That's the title of what this stage is for the World Health Organization.

It's at Level Three of a level -- of a series of six, .... and there continue to be this drumbeat of cases really around the world, just in the past several weeks in Egypt and Laos and China and other places when people are exposed to sick birds.

What we're worried about is that when the virus picks up the ability to do what regular flu does, and rapidly transmit among people, then you have a pandemic.

Therefore, every time there's a case or a little cluster, that's what triggers these large investigations to figure out, "Is this the one? Is this the one that has triggered some new event?"

The virus, as he's mentioned, continues to evolve. As it gets into birds, it's going to get into more and more people and every one of these -- is an -- every one of these opportunities to -- among different species is an opportunity to -- for the virus to then pick up the mutations that it may need to trigger a pandemic.

GARRETT: ...
We now know through a specific mechanism, we've now seen that the virus has evolved radically. There's two distinct trees now of H5N1 viruses with sub-limbs, and most of that evolution has been quite recent. And we now have the University of California's study that shows that the -- almost all the new strains are coming out of one place, Guanjo, Guangdong Province, China with the duplication being that there are specific events going on in the ecology in that place that are contributing to this mutation cycle.

So all of that seems very worrying, especially when we add to it some indication that two amino acid changes were the key to turning the 1918 flu from a benign virus for our species to a rapidly transmissible virus for our species. You know, that's just a couple of point mutations. Ouch. That's scary. It's not like the virus has to go through some big, radical change.

GELLIN: I think what's new there is the science that's examined the phenomenon in the past. As Michael said, there have been ten pandemics in the last 300 years. All of what you said is predictable and we knew that every one of those things would happen, and in the same way that we have to get a new vaccine for flu every year, we're now seeing that with this continued evolution of the H5N1, which makes the vaccine challenge phenomenal because we end up having to chase each strain because we don't know which one or ones like it might the be the one to trigger a pandemic.

So we've actually gone now into trying to develop vaccines at least in small lots to be able to make sure we understand the technology to be ready for this array of them, not knowing if it's any one of those or some other one.

GARRETT: But what's -- why? We know the virus is going to mutate, why are we buying H5N1 that's against -- a vaccine against the currently circulating spread?

GELLIN: In the hope that it gives you some protection while you're retooling and making a vaccine of the pandemic.

What we're -- we've spent a lot of money, and you mentioned the budget that the president put forward. He asked for over $7 billion. The largest chunk of that was for vaccine development and to really -- to turn around the vaccine industry.

OSTERHOLM: ... it's been like trying to fill Lake Superior with a garden hose. Basically, when you think about it, it's not just a function of new discoveries. It's production capacity. It's timely production capacity. We're making a 1950s vaccine in just a little bit fancier way. We don't have the capacity to make vaccine in a timely way for the vast majority of the developed world; let alone the entire world.

So the point being is that we need a sea change, and it's not going to come in a couple billion dollars here and a couple billion dollars there. When you think of the threats to the world, not just in terms of death and illness, but in terms of economic stability -- in terms of short, intermediate and long-term economic impacts, I can't think of anything bigger than this.

You know, having been involved with terrorism, having been involved, Laurie, in those early days of HIV/AIDS, having been involved with any number of emerging areas, -- you can put them all together in one bucket and they don't equal the potential for what this can and will do.

I likely believe it's the case. So I think that we really have our priorities out of whack financially, whether we believe the enemy is from within or from without, if we believe it's chaos, it's terrorism, it's whatever, we ought to be putting a much greater emphasis in a timely way. Even if we continue this approach and we continue to put the money in that's been committed, we are years and years off from having a vaccine that could be available in a timely way for this country, let alone the vast majority of the world.

GELLIN: The current -- let me back up a little bit. The system that the World Health Organization uses now for seasonal vaccine is the global surveillance system they've used for 50 years. And that's been -- where viruses are isolated in different parts of the world, and the assessment is made, and the ones that are turned into next year's vaccine -- which is why you always hear about things with strange names on them, because that's where these originated. And that has been the system in place for a long time.

Now we have the situation where viruses pop up in other places. And now a country like Indonesia says, "Wait a second, this is our intellectual property. We're going to take advantage of the only lever we have." I do need to correct one fact -- because we've spent a lot of time talking with the companies about this as well -- and despite what's in the press, the companies, across-the-board, are trying to work with the World Health Organization and don't want to take a virus from a country because that would then get them down a road where every country, every province, every everything is going to say, "Well, how about mine? Make my flavor." So it's -- it's a -- that's a pathway -- actually, if the companies go down that route, where there's -- it's going to splinter the entire industry and nobody's going to get anywhere.

What is going on though, is that Indonesia has decided to withhold this "sharing" into the World Health Organization. That's a big problem because of what we just talked about as far as just me making an assessment of 'is the virus changing.' I'd mentioned before, every case needs to be examined and we need to figure our whether this virus has changed. We need to worry about it and retool and make a vaccine.

You gave numbers before about the current case counts that the World Health Organization of 291 cases and 170 some odd deaths. There are a dozen or so cases in Indonesia that Indonesia has identified, but have not been -- not been acknowledged by the World Health Organization because they haven't seen the virus. The virus has not been shipped, so just making that assessment, "if the virus is changing," is now impossible given that stance.

So as you mentioned, this is something that the World Health Organization is trying to get their arms around. It's clear that linked to this is the importance of access to vaccines. They put out a plan six months ago about a large program -- it's been poorly funded so far. The United States has put in only $10 million so far, to begin to help developing country manufacturers begin to make -- to make their own flu vaccine. But as Michael said, that's the garden hose in a large lake.

So there needs to be attention being paid to access, to ensure that there is more capacity and more access. I worry about the slippery slope of what this might mean, not just for flu, but for all of pubic health when there's intellectual property being tagged on wild viruses.

And I think one of the things that's really critical here -- that people don't understand is, there's this focus and almost this altruistic concept of the developed world versus developing world. Yet today if you want to look at it from a strategic and tactical economic standpoint, the vast majority of the goods that you and I count on every year are coming from the developing world. So that if you want to look at those medicines, you want to look at medical supplies, you want to look at any number of things -- like you go through food supply sources, et cetera -- it's coming from the developing world.

What happens in Asia will have tremendous impacts on what happens to us. So it shouldn't be about just an altruistic concern that we want to take care of our brother in the developing world, it is about being strategic and tactically approaching the issue of our economy. And I don't see that concept at all -- it's almost foreign. And I think that that's where we have to start to hit home -- and the function of time is critical here.

And so part of what's happening here is, how do you bring a view? You mentioned the issue of -- people are somewhat dead to this. I came up with a concept about six most ago called "pandemic fatigue," which I think we're in the middle of.

You can't sustain this ongoing concern about preparedness -- investment in preparedness, if that's the concept you have and that's what we're really at. And what we need to do is step-up our preparedness much, much more than we've ever done at a time when it's at an all-time low.

GELLIN: Well, I congratulate you that you can go a half an hour into a discussion -- that's the difference between now and 2005. Before, Tamiflu equaled "preparedness." And you had to go a long way to tell people that Tamiflu might be important. It might not work, but it's only one piece of a number of different things -- from vaccines, to community mitigation strategies, to international investments. But clearly this is a virus, and an antiviral could have a big effect against it.

At the same time, the sprinkling reports you hear about its effectiveness is very hard to gauge, because this is an aggregate of these case reports that have happened around the world -- and the plural of "anecdote" is not "data." So part of this is to have a better system to monitor what actually people are being given, to see what's working and not, because -- and as we saw in SARS, a lot of things got thrown at a lot of people -- and some of those were probably not good for them, let alone trying to help them.

We need -- what we really need is to diversify the number of antiviral drugs that we have.

We currently have only two, in one class, that would work. Tamiflu is made by one company. Relenza is a -- is a similar drug made by a different company.

But as we know from the field of antimicrobials, the more you use these things, the more likely you are to lose them. So it's not going to be long until resistance could develop that could take that off the table. So part of this is to have a better class, a better set of antivirals, at the same time. But you can't not buy this as an insurance policy.

GELLIN:

But it was sized based on -- through the assumption of how many people would benefit from -- who might get sick. As Michael suggested, these are drugs that have -- they're indicated to use for prophylaxis as well. And when we start using these for different purposes, you would need a lot more. We need to have that discussion. We couldn't have it before because there wasn't enough around. The companies have increased their global capacity and that at least now allows us to think about how to use these drugs in the same way they're indicated for the season.

GARRETT: Let me -- before I go to the audience, my last question to you: Robert Webster's really the kingpin of influenza virologists. I think you'd be hard pressed to name anyone who knows more about influenza viruses about Robert Webster.

Recently at a conference of flu virologists, he said that the entire effort has failed. That "To me it seems that we've failed. It's a lack of knowledge and political will to get at the source of the virus. It's a general failure. I'm not pointing a finger at anyone. I've also failed. We as a whole have failed to understand the ecology of H5N1 well enough to control it."

OSTERHOLM: Yes. First of all, two things: I have a disclosure to make -- which I should have made at the beginning of my talk, which I didn't -- is I know less about influenza today than I did five years ago.

And I would tell you, anyone who's in the influenza business that doesn't acknowledge that isn't being honest with you, because as much as we've learned, we've learned how little we really know, because it's challenged many of the dogmas that we've had about influenza. So I think one of the things that Rob is saying is that we thought we understood the ecology a lot better than we did and we don't.

But the second thing that's happening is that in 1968 -- the last pandemic we had -- China harvested about 12 million poultry a year. Last year they harvested over 15 billion. The world has changed dramatically. We have many more livestock animals, birds particularly, on the face of the earth to feed the growing population. With 6.5 billion people on the face of the earth, one of every nine people that's ever lived is here today.

And so from a food-stock standpoint, if you look at Asia in particular, the number of domestic birds -- it's estimated that 80 percent of Indonesian households have birds either in their house or in their backyard as just a function of their everyday food supply needs -- their protein. So we've so changed the potential for the ecology from that perspective and we hadn't really understood or considered that.

Think about a virus that 30 or 40 years ago would have burnt itself out in the sense that there wasn't replacement birds. There was just not enough of them there. Today it's basically genetically wet out there, because everyday that a billion birds are harvested somewhere in the world, another billion birds around the world are hatched.
GARRETT: So the evolutionary process is being manipulated by human beings.

OSTERHOLM: Well, it's being substantially changed at least. And so I think the point is, what Rob is saying, is that no one understood the complexity of the avian population dynamics with humans -- both migratory wild birds as well as in particular, domestic birds. This is true.

Nobody had any idea. We always used to think that birds basically pooped out the virus -- it came out the south end. We now know that Mallard ducks cough it out and get it through the respiratory track in very large numbers. No one knew that until recently. And today, again, that plays a potentially important for moving it from location to location, farm to farm, et cetera.

So I think that what Rob is just acknowledging is the reality of this complex world. And I would think he's being a little hard on himself or others to say that we failed when we just had no idea what we were doing. And so in a sense, it's just a function of recognizing the difficulty of this whole situation and how complex it is.

GELLIN: And we can't forget -- these are essentially -- the reservoir for flu viruses are in birds. That's where they've always been. And now the whole world is fixated on H5N1. The rest of the world can hardly another virus, but there are 16 different H's out there. And I think the point is that while we're paying a lot of attention to this one, as we need to, Mike's comment before about these pandemics happen. They've happened before; they're going to happen again. It may be that this is a virus that for whatever reasons that we don't understand, doesn't have the ability to become a pandemic. But we know that these viruses do as a class and they're all over the place and there are reservoirs in birds.

So I think that all of -- the good part about all this is it's finally put this stuff above the fold. People have paid attention to the real threat of a pandemic and it's ratcheted up a lot of things that are not just H5 specific.

GELLIN:

But I think the point is that there is a lot of information that people need to understand. Regularly I use my mother as a focus group, because she tells me a lot about flu that is not quite factual, but I think that she represents the way a lot of people get their information and what they're thinking about. And at least -- the web, at least, gives an opportunity to have people go and ask for -- and get some answers.

So this was really driven so people could have specific questions answered and go find them somewhere on this essentially government-wide website. So I think it also speaks to the importance of broad educational campaigns and the kinds of things Michael was talking about. This is not just a public health problem. This has got the potential for a global not only social, but economic catastrophe. Everybody's got a stake at this and everybody needs to know what the facts are.

GARRETT: So we're going to open up for the Q&A now. And the first question is from Portugal from Tony Jenkins (sp) asking: Given that the first line of defense will be social distancing and that the N95 masks are not very effective at blocking anything as small as a virus, why have we not seen advances in producing better, cheap disposable masks? Is there anything that can be done to spur this field?

OSTERHOLM: Well, this is a classic example, again, of the current business model. I won't go into the premise of social distancing and so forth. I think that's still an issue of some discussion. But clearly, respiratory projection, as we know it -- either N95s, which are a type of tight face-fitting -- what some people call masks. We call them respirators that actually are there to really keep out even more potential virus particles from getting versus the surgical mask, which some would argue is quite effective. Others would say less effective.

But the bottom line is that the world is really, again, a supply world. There are several companies which own the large market share for the entire world that make an N95 mask. They've only done a limited amount of increase of their product production, because they have no guarantee down the road anybody's going to buy it.

And you know, today when you think about this -- and this is a non-economist, epidemiologist saying this, so I apologize in advance -- but you know, we criticize Department of Defense contractors that basically make things that cost $45 for a lug nut or $82 for a toilet seat. What we have to understand is that when they actually go in and contractually -- to come up with a contract with the federal government, they're coming up with -- if we're going to build 400 of these, we're going to amortize the entire cost earning we have to build the plant, to make those and to bring the plant back down again because we're not going to use it again once we make that. And so in a sense, things get exaggerated in costs when you realize that cost. There are many companies out there today that would do more to ramp up their ability to provide these kinds of things if they knew that if they built this plant that for 20 years it would get used -- not a one-time six-month or eight-month hit, where then after that we don't need it anymore -- because they can't amortize the cost of all the investment into doing that over the life of that entire plant.

And so we have no --

GARRETT: But do we even know -- Bruce -- (inaudible) -- do we even know what kind of mask works?

GELLIN: We don't know.

GARRETT: No.

GELLIN: I mean that's -- I think that we have to acknowledge that the science of how masks might protect is weak. But I think --

GARRETT: So if I'm a company and you're telling me to ramp up, so --

OSTERHOLM: I don't think that's the case. We know that N95s work. N95s work across a variety of different organisms, and flu is not anything special that way. I mean, frankly we know a lot about infectious agent transfer, whether it's a bacteria, whether it's a virus, whether it's particle-driven, whether it's aerosol -- we know a lot. I think the question is, how much would masks work? But N95s, I don't -- there's no debate that in the health care setting we've demonstrated for decades how effective they can be against similar particles. So I mean, ideally we could use masks.

But the message applies for both masks and respirators. It doesn't matter. We don't have a world economic model for a company altruistically to build all these plants with the hope that someday you might use it. And so if we're going to want it, we've got to buy it. And we have to buy it in a way that makes it financially logical for that company to invest in that. So when we continue to see major shortages in a lot of these supplies today, people will say, "Wait a minute. In a free, global market economy, shouldn't the -- you know, if we're asking for more mousetraps, they should build them." No. That's not going to happen. And that's been a poorly understood part of preparedness. That's -- just hasn't happened for that very economic reason.

GELLIN: But the issue -- the same issue you raise about the manufacturing capacity -- actually, it's true for the vaccine piece as well, in that you're building a massive capacity for the hundred-year storm, and that's it. So I think part of this is an opportunity for innovation, to think about -- I mean, when you use these masks you have to change them regularly. It's not like you just have one mask that you keep for the rest of your -- for the rest of the pandemic. You have to change them all the time. So the masks -- the quantity of masks that you might have to go through is enormous. So I think here is an opportunity to think about innovation and maybe we can bring about the next generation of masks -- a reusable, washable mask.

OSTERHOLM:

I mean, with all due respect, what happened here in New York City on 9/11, as horrific and horrible as it was, in several hours it was over. The recovery was already able to begin. When a pandemic hits, it's going to unfold for weeks and weeks and weeks, and there are going to be so many unanticipated global issues that will come up where, for example, what do you do? Let me give you a case in point. You can't -- you can't drill this. You can't exercise this.

In 1968, the average time from a casket being made until it was in the ground was six months. Today it's less than four weeks. A growing number of our caskets are coming from China. Most of the parts that we use today to make caskets come from China. We're going to run out of caskets overnight -- literally we will in this country. Now the other part of that is, well, we'll just use crematorium space. Well, you know what? Crematorium space in this country is a just-in-time delivery system.

We learned from both Katrina and from the Indonesian tsunami that, from a psychological standpoint, what took people over the edge in both of those was not just the events as they unfolded, but it was watching the disrespectful and untimely manner in which we handled the dead bodies. And I would argue today that what will be a very major tipping point in our communities for how people perceive we're doing and the potential for what I call outright panic will be is if we don't handle, in a timely and respectful way, our dead. And today, we're less prepared to do that because we're so used to this just-in-time system, than they were in 1918.

OSTERHOLM: Let me just finish up because then -- the point is, you can't war-game that; you can't tabletop that because it's an afternoon. And so what we need to do is both what we're doing -- and so, as I said, we teach this; we're very supportive of this -- at the same time, we've got to start thinking much bigger. You've got to think way down the road -- the three weeks, the five weeks, the eight weeks out piece -- and that's the part that's been lacking.

GELLIN:

Related to that, we've actually had another -- that's why I asked you about which one of these exercises because we do them a lot -- and they're -- in fact they're designed to create chaos and to cause failure so you can really learn something from them. We've, over the past three or four months, had a series of these exercises around the country with local media to try to get a sense when a scenario's unraveling of what information that they want.

So I think that's actually been among the most important things for us is to try to understand how the media is going to be looking at our perception, what kind of information they need, the access to the information, the access to trusted sources. And clearly related to that is the importance of clear communication.

This little prop was just one way to get people to begin to answer some of their questions, but it's critical that -- in Michael's fog of war there's going to be a lot of confusion unless people know where to get the truth and how to know -- and know what's going on, what people are doing about the problem and where to get information for themselves -- that chaos will escalate.

GELLIN:

But you've asked the most important question. My understanding -- in the places where some of those background -- that background information has been looked for -- is that the -- that the fatality rate is actually quite high, that there are not a lot of sub-clinical illnesses. You would expect actually a lot of that illness in these poultry workers -- the people doing the culling. There's not a lot of it there. So it tells you that, for whatever reason, those people who get infected -- it may be that -- their proximity to the virus; it may be related to their own genetic makeup; it may be related to the amount of virus that they are actually exposed to -- when those people get sick, they do very, very poorly. But right now, the other thing it tells us is this virus is not terribly transmissible.

GARRETT: And the other thing that the epidemiology tells us that the majority of the people who get truly a horrible illness and fatality are under 30 years of age, which is -- was the case with the 1918 flu.

GELLIN:

Your question about reapplying is several questions at once. If you get sick with influenza during the season this year and receive this drug, and you get sick next year, you can receive that drug again. I think the nuance behind your question -- is the one that Michael was talking about -- is the opportunity to provide prophylaxis -- if you're not sick, but to provide prolonged prophylaxis.

The package insert which means -- which indicates where there's significant experience and have taken that data to the FDA says it's safe to take that drug for a period of six weeks.

Now, that raises the question of in the pandemic, if you were going to prophylac someone for a longer period of time, what would that mean? And I think we'd have to have more data to get a better understanding of that, but at least as far as that goes, we do have experience with six weeks worth of prophylaxis which would be one pill a day.

OSTERHOLM: I might add that there's a bit of confusion today, and I think that you're going to see some blowback on the issue. What Bruce just shared with you is absolutely correct on the shelf life extension issue. But that applies almost exclusively right now to the federal government purchase of that because the other individuals or groups buying this -- including state governments and private companies -- are not part of that program, and therefore their product is not being held under necessarily the same conditions, which right now the FDA does not have the ability to actually extend the shelf life on that.

So many companies that have bought Tamiflu will find themselves potentially -- and hopefully we can reconcile this before the five year period is up -- with five years worth of Tamiflu that's now outdated and not considered to be potentially effective -- even though I would argue it probably is and I would surely use it in the face of a pandemic without any hesitation.

GARRETT: And it will only be worse if you happen to be, say Vietnam or another tropical, hot climate trying to find a way to store for years on end. Indeed, I understand that Vietnam and Thailand are both requesting that they be able to dump their current stockpiles -- which they think are no longer any good -- and buy Tamiflu and looking for funding to do so.

GELLIN: Well, it's not either-or. I think that there's a need to prepare better for seasonal flu. We know that hospitals often get overloaded, and that's a separate question -- but I think that the point of preparing for pandemic is it's much more than the health sector, it's much more than emergency room, it's all society.
... It will be everywhere and it will be in many places and therefore every community needs to be prepared.

So I think that point of that is to, in your own communities, have an understanding of what's happening in your own communities, the degree to which there is a local plan, and the degree it's being practiced.

OSTERHOLM: You know I would just say I strongly disagree with that conclusion. Whoever shared that from Homeland Security I think is part of the problem that we have today in this country, in terms of planning for a pandemic.

Last year in this country, a person every minute, once every minute, 60 every hour, were diverted on their way to an emergency room that they desperately needed because that emergency room was so overfilled that it was determined that their status would be more compromised by going to that emergency room than diverting to one farther away.

Today our health care system or really more appropriately called the disease care system in this country has been gnawed down to the bone and we're sucking calcium.

We have no excess capacity in our health care system -- none, zero, zip. And we're already hurting. Now you overlay a pandemic and we have to come to the realization this health care system will not handle it.

First of all, when people say, well, this is, you know, the 21st century -- we'll have antibiotics. Today antibiotics are a just in time delivery product in many hospitals. We've seen an increase number of hospitals in this country get deliveries three times a day now for pharmaceutical and central supply products. We'll run out overnight. I worry about things like, as I said, insulin. Just how much insulin we'll have in this country -- again, much of it coming from offshore.

So what we have to do is plan not to integrate pandemic flu into our health care system, but, first of all, just figure out how the hell we're going to keep our health care system afloat for people who still have heart attacks, for people who still have cancer, for people who still are going to deliver babies, for people who are still in accidents, and how are we going to keep that going, knowing that there are going to be a lot of doctors and nurses that are either going to be sick, that are going to be home caring for their own family members, or that are going to be too afraid to come to work. And that's the part that we haven't thought about yet is we've got, I think, we're on parallel tracks.

Today, health care during a pandemic will be cheap. How expensive is it to provide good nursing care? That's what it's going to be. And so, if you don't plan for that now -- that's going to be like planning for Katrina where everybody's going to have a credit card voucher to go and get food after Katrina hits, but everybody forgot there was no electricity to run those credit cards on. That's what we're talking about.

So I think that that's the key message today is communities have to plan for a system that won't take much more to tip it over the top, but yet a system we need to maintain the best we can for those things and a system in addition for pandemic flu.

Any community that's not thinking about that is going to be in big trouble very quickly.

...

OSTERHOLM:

And part of it has to do with the electronic age. It's pretty **** hard to have anything happen in this world today that we don't pick it up somewhere on the Internet. Much of the chatter is wrong, much of it is incorrect, it's sensational, but there are very few times that we go back now and find things that happened months ago that would have occurred, I think, 20 years ago that we didn't know about.

And so I think given as Bruce very appropriately laid out, the vast majority of this disease is very severe disease. The serologic studies confirm that. We're not seeing a lot of this. Now, if that changed and we had a lot of milder illness, yeah, we might miss it. But we're not.

And so I think right now -- and I think SARS helped us -- SARS actually was a tipping point because SARS tipped people off to the power of the electronic word and the fact that today that the Internet is this incredibly powerful tool -- you can be in the most rural areas of the world and we can still find out about things. And we've had examples of that in Africa recently.

So I don't think we're missing a lot. I would have not said that a while back, but that again is again predicated on this more severe disease. If this should become a milder disease, then, I think, yeah, we could start missing it because people just wouldn't know what to report. But I'm confident that we're not missing a lot.

GELLIN: The companion piece of surveillance is the actual diagnosis. And Michael's right, I think the good part and the bad part is the electrons go pretty quickly. I think the problem is to ensure and that there's been both from United States and other governments have been investing in some of the laboratory capacity so that when some event happens somewhere, a local lab can make the call in a reliable way. Because you don't want it being made wrong either because it was right, because it was H5 and you called it something else, or the opposite. So I think there's -- that is where there's been a substantial amount of investment, there's still a long way to go.

There is a -- there have been a couple of these pledging conferences. A year-and-a-half ago, there was one in Beijing where the countries of the world got together and pledged almost $2 billion. There was a similar pledging conference in Africa last year. I think that cashing in on some of these pledges and turning those into programs is the challenge. But at least there is -- those pledges are out there. The U.S. has given a substantial -- has donated a substantial amount, not only to the World Health Organization and the FAO, the agricultural group, but also bilaterally with many countries. And as you suggested, we're members of as many clubs as we can be a part of, where there's some activity that's going to move these forward.

GARRETT: Well, we have a rigid rule here at the council. We always end on time. So I want to give each of you two minutes for your final comments so that we can, indeed, end on time.

Mike, why don't you start.

OSTERHOLM: Well, I'd like to again thank the council for having this event. We can use all the help we can get right now to keep people's interest in terms of moving forward in preparedness.

...

So I think, from a standpoint of security -- from a standpoint of both economic security and I think just whole-world, the entire world security in general -- this has to be a much more front-and-center issue. And I don't see that happening. ... I think there's much more that all of us can do. And, I think, in paraphrasing the words of the great famous Ben Franklin, "We must hang together or we surely shall hang separately."
And I worry one day there'll be a post-9/11-like commission that will look at pandemic flu and realized there were many, many, many opportunities to be better prepared and we didn't take them.

GELLIN: Well, I think I have to applaud you and the audience for coming, because as you -- your premise here was that a lot of people think this problem has gone away. And I think it's important to recognize that it hasn't -- and everything about it keeps us up at night and worried that something might happen. That next shoe might drop, it might be going on right now, and we have to keep our guard up.

At the same time, we're often -- always asked the question of, "Are we prepared?" And I think that that is a continuum -- I think that we are clearly a lot better off than we were. We didn't get it all -- talking about some of the domestic issues, and getting -- and trying to understand where states are with this level -- with preparedness. But they've gone -- they've really come quite a long way. All states now have plans; they're all doing exercises. I would encourage you to find out in the place you live what's going on, and what they've learned from those, and what they're going to the do about it.

But I think that there has been -- there has been, at least within government -- both the federal government and the state governments, there has been a massive increase in attention being paid to this.

Our fatigue is because we're doing so much work -- not because we're tired of doing it -- but I think we still have -- we still have quite a long way to go.

THIS IS A RUSH TRANSCRIPT.

http://www.cfr.org/publication/13115...s_service.html

**Theresa42** · April 21, 2007, 11:02 AM

Re: Osterholm & Gellin - BF Still a Threat?

Originally posted by gsgs View Post

most interesting for me was (AFAIR) that Russia has Tamiflu for 95% of population (when did they decide to buy it ?)....

That is interesting! I hadn't heard that before.

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Osterholm & Gellin - BF Still a Threat?

Osterholm & Gellin - BF Still a Threat?

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