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Council on Foreign Relations Conference on the Global Threat of Pandemic Influenza, Session 3: The U.S. Government’s Role [Rush Transcript; Federal News Service, Inc.]

Speakers: Jeffrey Levi, Senior Policy Adviser, Trust for America’s Health, Susan Blumenthal, Former Assistant Surgeon General, United States, and William Wikenwerder, Assistant Secretary of Defense for Health Affairs, U.S. Department of Defense
Presider: Brian Ross, Chief investigative correspondent, ABC News
November 16, 2005
Council on Foreign Relations



Council on Foreign Relations
New York, NY

(Note: A small number of misattributions have been corrected in this transcript. This is the final version. Please disregard earlier versions as a few attributions were incorrect.)

BRIAN ROSS: Good morning. I'm Brian Ross from ABC News. Welcome to today's Council on Foreign Relations meeting.

Our topic in this session is the role of the U.S. government in terms of a flu global epidemic. We're joined by Jeffrey Levi, the senior policy advisor for Trust for America's Health; by William Winkenwerder, the assistant secretary of Defense for Health Affairs. We're not being joined by Eric Noji of the Centers for Disease Control, but instead a very worthy substitute, Admiral Susan Blumenthal, who until this year was the assistant surgeon general and is a renowned health expert in her own right.

In any national emergency, including a global flu epidemic, Americans will expect the federal government to pay a key major role. The poor performance of the federal government in the aftermath of Hurricane Katrina has raised many questions about not only the role, but the ability of the federal government to perform in such an emergency. Secretary of Health and Human Services Michael Leavitt told me recently on a broadcast that the U.S. is still not as prepared as it needs to be for a global flu epidemic. The secretary said he could not answer why the U.S. was slow to put in its orders for Tamiflu, a failure that occurred before he took office.

So among the questions we hope to pursue today are: If the U.S. government is not prepared, why not and what steps need to be taken? Are states and cities prepared? Can the U.S. public health system sustain a two-year outbreak that might kill millions and infect many, many more. What role should the U.S. military play in the case of a global epidemic? Who actually would be in charge from the point of view of the government? Does President Bush's recently announced emergency plan make sense? Does it go far enough? Does it have its priorities set straight?

I'd like to remind the audience that -- and our guests -- that this meeting is on the record, and I ask all of you to remember to turn off your cell phones and Blackberries or at least to put them on vibrate or stun. (Laughter.)

Let me begin with Secretary Winkenwerder. Do you think that the epidemic plan put forward by your commander-in-chief is sufficient? (Laughter.)

WILLIAM WINKENWERDER: Thanks. Thanks for a great opening question.

What the president put forward a couple of weeks ago was a national strategy. That strategy sits atop a Health and Human Services medical and public health response plan. As we speak, the Department of Defense, Department of Homeland Security, Department of Veterans Affairs, other federal -- Department of State -- have been working -- in fact, before these plans were even made public -- on pulling together a national response plan. There are exercises that are going on. There will be more exercises among senior government leaders here in the next few weeks.

So I think that, actually, a very good plan is emerging. The HHS plan is an excellent document.

The real work, it seems to me, though, needs to be done not just at the federal level, but at the state and the local level, actually facing the hard facts of the possibility of a very difficult situation. And when you do that kind of scenario playing -- exercising -- you find out where your gaps are. You find out where you thought it might only take hours or a day to do something, goodness, this is taking two or three days; this is an unacceptable time lapse.

And so until more people get engaged in this planning effort, particularly at the state and local level, we're not going to feel -- we're not going to be -- as well prepared as we need to be. But I'm pleased, particularly with the pace of work that's occurred really in the last three or four months. It's really picked up pace.

ROSS: And what do you think will be the role of the Department of Defense?

WINKENWERDER: I know there's been a lot of discussion about that. Our first role, and certainly my first obligation as our chief health officer, is to ensure that our own military are protected so that they can continue their military missions, whatever those missions might be. We're obviously a critical national security asset. So we are stepping along a pathway to ensuring that we can do just that.

Secondly -- and I'll talk more about that -- secondly, our role is to support the lead federal department or agency -- in this case, it would be the Department of Homeland Security -- as the leading department in coordinating an overall federal plan.

ROSS: That's the lead agency, then?

WINKENWERDER: The lead agency. On the other hand, the lead component of that for public health aspects is the Department of Health and Human Services. We are in ongoing dialogue, literally all day every day, with both departments -- have been for weeks, months, on this issue. So -- but there are a variety of ways that the Department of Defense could assist way before any effort that might be -- have us involved in some sort of assistance with quarantine. I know that's been brought up.

But we are involved in surveillance internationally. There was the discussion earlier here about Indonesia. We have a laboratory in Indonesia. That laboratory works closely with the Indonesian government. We're bolstering that surveillance capability. We have laboratories around the world, and these are important assets for the whole U.S. government -- laboratory testing capability here in the United States; surveillance here in the United States; medical logistical support, very important in the event of needing to rapidly distribute either antiviral medication or vaccines.

So we're looking at and working on a variety of different scenarios and ways in which we could be most helpful if we were called upon to do that. But to be sure, we're not the lead agency; we're a supporting department.

ROSS: Admiral, let me ask you next. What do you make of the president's plans? Are the priorities correct? It seems there's been a lot of talk that the states and cities are nowhere near prepared enough.

ADMIRAL SUSAN BLUMENTHAL: Well, I think that there have been billions of dollars allocated to the president's plan, and it has several pillars which I think are important and critical to a response. But the issue becomes, again, where the monies go, and right now we have a skeleton, but we need to put the flesh on it in terms of adding the initiatives that will make a life-saving difference to people in America and around the world.

You asked earlier, why is it that we haven't had a pandemic plan until today? We haven't had one in decades. And I would just give a historical context here. If you think about the Greeks, when they took the Hippocratic Oath, they swore to two gods -- Asclepios, who is the god of medicine, and Hygeia, who is his daughter, the goddess of public health.

Well, public health and medicine work side by side, and medicine trains you, as a physician, to treat one person at a time, where public health trains us to intervene to prevent disease at the community level, the national level and globally.

Well, in 1969, the surgeon general of the United States declared that the war against infectious diseases is over, and it was because of the triumph of government-sponsored public health interventions -- sanitation, hygiene, vaccinations, later on environmental and safety regulations, improved access to health care and antibiotics, that eradicated diseases like smallpox and diphtheria that were major killers of people, forgetting that we lived in a global environment and that one out of four deaths worldwide are due to infectious diseases.

Today we face a double jeopardy from both infectious and chronic diseases, but because we forgot the public health lessons of the past, we tore down that infrastructure, which, after 9/11, the anthrax attacks on its heels -- SARS -- we found ourselves having to reestablish.

So after anthrax, $4.6 billion was put into a new initiative called BioShield to create new vaccines and medications to deal with a biological threat. We also put billions of dollars into developing infrastructure at the federal, state and local levels to prepare for a terrorist attack or -- We also reassured the American people, to say it could be a hurricane, or it could be some other illness.

I think that the issue is where are these funds going, and how can we better develop an accountable plan. After all, government people across agencies work very hard. Public health interventions have been a triumph and have given us in this room 30 extra years of life expectancy in the past century.

But we need to do several things. One, we heard earlier, we need a rapid detector for flu. We need to use the advances of science and technology and marry them with public health lessons from public health to get 21st-century solutions.

We need new vaccines. We have people dying -- millions of people -- 3 million people die of AIDS every year; a million of malaria. We need vaccines for these diseases, and we need them for flu, which has always been a major killer of people. We heard about 36,000 people in the United States, maybe 500,000 people worldwide die of flu.

So we have to remember clear and present dangers -- international killers that lurk in our world contemporaneously and not overestimate other threats.

And so I think the pillars of the president's plan are there in terms of surveillance, rapid detection, containment, control, accelerating science and the knowledge base, new vaccines, stockpiling. But we also have to think about how, if we don't have the antivirals, if we don't have a vaccine tomorrow, how are we going to work at the state and local level not to have panic in our communities and to have home health care plans -- home health kits -- to empower physicians, hospitals and localities to respond effectively.

ROSS: The bulk of the money in the president's plan seems to focus on vaccines and treatment. Does that essentially acknowledge that it's all defense; there's no offense; there's no attempt to stop it at the source?

(Cross talk.)

ROSS: I want to ask the admiral that, but I was --

WINKENWERDER: Yeah, I don't think that's a fair characterization, because a major element of the overall initiative of the national strategy, is outreach to the nations across the world, and the president really has taken the lead on this. He has taken this issue extremely seriously. I think people who work in and around the White House day in and day out would tell you that this is a high, high priority, a top priority. And so a lot of time and energy is being invested in communicating and reaching out. As I understand it, I think this week the president's involved in meetings on this issue. Secretary Rice has been involved; we're involved military-to-military. We're engaged in an exercise just on the U.S. side this week, today, in the Pacific region. We're beginning to engage our partners -- other nations -- particularly in that area of the world, to really think about how do we assist early and quickly, and how do we bring to the attention of leadership in those nations the need to make this a real priority.

I was encouraged by what I heard in some of the earlier sessions about the level of awareness going up. David Nabarro, from the U.N., his comments about the Chinese, I think, were hopeful.

ROSS: Jeff, what's your take on the current state of preparedness of the United States and the federal government?

JEFFREY LEVI: I think we have a long ways to go. I'm less interested in the details in a national strategy, which is actually a very brief outline, and more interested -- I think we learn people's priorities by where they're willing to put resources. And when the president requested an additional $7.1 billion, he identified some very, very important areas.

There's a tremendous new investment in vaccine development and production, which is very important and long overdue. There's some investment in building a stockpile for antivirals, and I'll get back to that in a second. But very, very little investment in supporting state and local health departments who are going to be on the front lines in responding to this pandemic; $100 million, that's all they've been given to do, essentially, some planning, perhaps some exercising of those plans, while the president's budget request expects the states to come up with $510 million to pay a share of the cost of developing an antiviral stockpile. That doesn't balance out.

When you look at the details of the HHS plan, again, we have a tremendous investment in developing the vaccine, but we don't have a mechanism for distributing it. Will it be the states who do it? Will it be the private sector? I mean, the bad news is we don't have a distribution plan. I guess the good news is it's going to be a while till we have a vaccine to distribute, so we have the time to develop it. (Laughter.)

The HHS plan is very detailed, but very detailed in saying what others need to be doing, around risk communication, around quarantine and isolation, around developing surge capacity. All this is left to the state and local governments to figure out what kind of surge they have, working with the private sector to do contingency planning, working with the hospital systems to develop all those things. That's going to cost a lot of money.

And while we have made a choice in this country to have a very decentralized health care system and public health system, there does need to be some central vision and central direction, particularly when you're responding to something of this magnitude.

Now, every state in the country is contributing National Guard forces to the war in Iraq. I don't think the president would like it very much if every governor decided that the National Guard who are sent to Iraq are going to follow that governor's strategy. We want a single strategy in fighting a war; we should similarly want a single strategy for fighting a pandemic. That doesn't mean there's not going to be local variation, but we need the guidance and we need the resources, because the real tragedy on all this is in placing the economic burden on state and local health departments and the full -- most of the responsibility for implementation on them, we're going to see tremendous variation. To ask the state of Louisiana in its current financial situation, to be paying 75 percent of the cost of antivirals for their state, well, that's just not going to happen.

And so what's going to end up happening is, where you live will determine whether you have a vaccine distribution system, whether you have sufficient antivirals, whether you have a surge capacity to address the pandemic, and that shouldn't be. When it's a national problem, we should be taking it on as a nation and assuring that every American has just as much of a chance to be protected and to survive the pandemic.

ROSS: So if it's your call, what is the strategy? If you're the president of the United States --

LEVI: What should we be doing?

ROSS: Yes.

LEVI: I think we probably should be developing -- we should be probably investing in greater levels of vaccine production beyond just protecting the United States. We heard earlier this morning how critically important it will be to have the production capacity for vaccine to help everyone in the world. It can be done if we're willing to invest the resources.

We, as, you know, the global superpower, have a responsibility to do that and from a selfish standpoint. The more vaccine that's out there, the less likely Americans are going to be to become sick. That would be one thing.

I would certainly want to see much greater investment in helping state and local governments develop the capacity to respond -- develop surge capacity, have all the supplies they needed beyond, as Dr. Osterholm spoke about this morning, beyond just vaccines and antivirals, and I'd want to see a lot more work done with the business community about keeping businesses running, keeping the economy going.

One very simple example, but it's a huge one, is, in the context of a pandemic, we'd want people who are feeling sick not to come to work. I believe it's 30 to 40 percent of Americans don't get paid sick leave. Well, guess what? They're going to come to work, when they probably shouldn't be from a public health standpoint, and we can't blame them.

So we need to look at huge areas that can be very controversial. Should there be paid sick leave for every American? When do we shut down businesses? When do we tell people not to come to work, and if we're telling them not to come to work, how do we make sure they don't pay the economic consequence? So there are very, very big complex issues that this raises. It raises it for a pandemic; it raises it for some other public health concerns that we're just beginning to address.

ROSS: Mr. Secretary, let me ask you, a lot -- (inaudible) -- the president raised is the issue that the military would be involved in creating quarantines. Is that the case? Would they even work?

WINKENWERDER: Well, he speculated on that idea. I don't think he --

ROSS: He certainly (puts them ?) somewhere, right?

WINKENWERDER: He didn't give any directions for us to execute on that order.

ROSS: How do you see it?

WINKENWERDER: We want to be prepared to assist in a variety of ways. I talked earlier about what I believe and, I think, what most people believe are the most and effective ways that we can assist. This early surveillance and detection, particularly overseas, working with militaries. Militaries in many countries are, you know, sort of the bulwark of stability in those countries and often themselves have some of the critical assets for health infrastructure.

We want to assist in the capacity for testing. The research, let me just note, the research that we've all been talking about here the last couple of weeks was performed in the Department of Defense -- Dr. Taubenberger, from the Armed Forces Institute of Pathology, reconstructing the 1918 virus. And I think that work has been critically important.

So we're involved in the research side on this as well.

ROSS: Have you kicked around the idea of a quarantine, how you would do it?

WINKENWERDER: You know, I think our view is very similar. We're public health-oriented, as well. Our view is very similar to the views that you've heard expressed today about the likely limited effectiveness of any sort of mass quarantine. But we want to be prepared to assist with things like people coming through airports, and -- I think that was talked about -- if needed, you know? If the state and federal government can respond and can do the job, that's great. But I think one of the things we learned, however, with Katrina, is that response capability fell apart. And so then where do you go if you're the commander in chief?

And so we have people; we have assets; we have the ability to move logistically. We've got a lot of experience in administering vaccine programs. Everybody should know that the basic group of people in this country who are protected today from smallpox are the U.S. military. We have continued our vaccination program, have almost a million people vaccinated against smallpox. The same thing for anthrax. And so we're prepared to do that and to assist.

But I think it's really important, going back to what Jeff said, about -- in my view, you can -- and I'm getting a little bit out of my lane, here, because I'm not from the Department of Health and Human Services, but -- and it was mostly their budget and plan. But the role of states and localities -- I think if the federal government steps forward and says, okay, we'll take and do all this, I think the response is that there's kind of an assumption that then the others don't have to respond; they don't need to re-prioritize.

I think this is a matter of re-prioritizing. We talked about that earlier. And this ought to move up the priority list, and so that means, you know, states are spending billions and billions of dollars in their Medicaid programs and other health programs. If they can't manage to move a few million dollars around to do some of these things, then, you know, how important is it?

LEVI: I think we need to be -- Brian, we need to be very careful about not robbing Peter to pay Paul. And, in fact, the president made that decision, because when he requested the $7.1 billion, which is a little bit less than what the Senate had voted for -- but in both -- the Senate voted this way, and the president requested that this be an emergency supplemental that would not be subject to the rules of finding offsets, because he recognized this is a unique and special event.

States don't have the privilege of running deficits, and to -- at a time when Medicaid is under severe pressure; we have increasing numbers of uninsured who are turning to the Medicaid programs, I think it would really be unwise to take part -- one part of the health care infrastructure, start dismantling that so that we can build up our pandemic response. This has to be in addition to, and to make up for, as Susan mentioned, years and years of neglect to the traditional public health infrastructure.

I want to add one thing, in support of what Bill said about, you know, really looking at the decisions that need to be made from a public health perspective; how quarantine is used, how other measures are used. That's very, very important.

And I think everyone recognizes it, especially after Katrina, that the military and other non-traditional public health agencies are going to play a supporting role. What's very important is to make sure that we emphasize that it is a supporting role and not a decision-making role.

And what does concern me in the president's national strategy is that, while the Department of Health and Human Services plays a major role, when push comes to shove, the decisions are going to be made at the Department of Homeland Security. The Department of Homeland Security needs to be providing the support that the public health infrastructure and the public health experts need. They should be the ones driving the decisions on how we respond, when we respond and where we respond.

ROSS: Do you think the program -- the plan -- is backwards?

LEVI: Well, I think the plan that he --

ROSS: Who leads?

LEVI: As to who leads, yes. HHS should be in charge, and the other agencies should be providing the necessary support. Now -- I keep using a war analogy; I think it's because Bill is here. (Scattered laughter.) There are probably many fewer military strategists than there are logistics people in the Department of Defense. Just because DHS is bigger than HHS doesn't mean that they should be driving this. DHS is, in a sense, the logistics folks. They should be supporting the strategy that is outlined by --

ROSS: Would you say --

BLUMENTHAL: Brian, I think that your analogy to war is quite accurate. I mean, we would say that a pandemic flu or malaria or AIDS are international enemies. We fight them with weapons of education, immunization, hygiene, antibiotics and the other tools of public health and science.

The Department of Homeland Security was created in order to coordinate across our various agencies for complex issues, but we also have to be agile, because when we saw something like Katrina, I mean, judgment is critical when you go in, when you mobilize your forces. And I think, again, the health component has to be at the forefront of a pandemic response, and can be even within the Department of Homeland Security, as long as those voices are loud and clear at the table.

I think the Department of State has -- is now playing a major role. We understand that these diseases are national security threats. They're economic threats, they're humanitarian issues, and so they are critical players at the table.

But coming back to your point, until we have a vaccine, until we have effective antivirals, much of the response will be at the local and state level, and they need a recipe for how to put in place, with partnerships -- with the federal government and with the localities in the private sector -- a plan. And it also means that we need to do masses of flu preparedness education to our public. And, again, the CDC and other agencies have put together, a website. We have, on how to prepare for emergencies.

But there's not a lot of information there yet -- the flesh on the bones that I was talking about. How -- again, you were saying in terms of the businesses -- how families, how schools, should respond if there is an outbreak. What you as an individual can do; home care, what you should have in your home preparedness kit for the flu. How, if there are -- should be a vaccine or antivirals, how are we going to deliver them? Do you want the patients to be coming to the doctor's office if they're sick, or do you want to have some system, through home health nurses or through some other delivery system, to get the antivirals or medications or visiting nurses out to the homes? I mean, these are the kinds of details that really need to be worked out.

ROSS: Let me ask you, why aren't they worked out now?

BLUMENTHAL: I think, again, because we have -- we have put other risks at the forefront. You know, as I said to you, we grew complacent about infectious disease in our country. We were not thinking globally, although I must say that the administration has really moved a lot of global health issues to the fore; has taken a leadership role in the global fight against AIDS and malaria and really has escalated efforts. It's not enough, but there's much more being done.

But I do think that we've underestimated the risks of diseases that are with us. Hurricane Katrina was a wake-up call on the heels of anthrax and SARS. We learned that many of our public health departments, as many as one-third, were not connected through a seamless phone system or Internet. And, you know, we should be farther along building that communication system. We've got to rehearse; we've got to make sure it works.

For example, in the Astrodome there was only one satellite phone. We've got to find a communication system that will work. That will be critical, as well as risk communication to the public.

ROSS: Let me follow -- so, I mean, why don't we have that now, have any of the details that the admiral's talking about?

WINKENWERDER: Well, I think we do.

ROSS: We do?

WINKENWERDER: I think we've got some of the details. Yes, I do.

ROSS: Do we know how to distribute vaccine or antivirals?


MS. SUSAN DENTZER: That's the military. (Laughter.)

MR. LEVI (?): And you're the prime example of command and control. -- (inaudible) -- (Laughter.)


ROSS: That sounded a little greedy, frankly.

WINKENWERDER: No, no, no. No, we know how to do what we need to do to protect this critical asset, the United States military. We also, I think, have a very good idea of how we can and would assist the civilian sector. But I want to go back to another point about this lead, and clarify, at least to my perspective, about who is taking the lead here.

The Department of Homeland Security does have the lead when there is a national event, an event that is defined as a national event that triggers the national response plan. It's a lead and a coordinator. It does not mean it's the lead in terms of response.

And I think everyone is very clear, at least in the federal government, that it's the Department of Health and Human Services who is the lead response agency.

ROSS: So why shouldn't they be in charge?

MR. WIKENWERDER (?): Well, you can debate that, and I'm sure others have.

MR. LEVI (?): There's confusion for state and local health departments. They get direction for both agencies, and they get grants for both agencies.

MR. WIKENWERDER (?): But the issue is this: Do you create a different lead agency for every different kind of issue? And I think the conclusion for now is, no, we're not going to change and make different departments the lead depending on what the issue is.

ROSS: So the expertise at the Department of Homeland Security is organizing others?

MR. WINKENWERDER (?): And supporting.

ROSS: They really haven't quite demonstrated that.

MR. WINKENWERDER (?): I fully expect -- let me just say on the health side -- let me just say on the health side -- in Katrina, and more especially in Rita, there was excellent communication and coordination at the federal level among the health community.

That portion of the response worked pretty well, and actually got much better with the second.

I started 10 days after 9/11. My first experience was walking into the White House press briefing and trying to describe the anthrax specimen that we had. We've been through that. We've been through the tsunami, Katrina, Rita, SARS. We've gotten a lot of practice.

And we are continually working to get better. But I just would have people believe that our relationships and communication between let's say our department, the Centers for Disease Control, the lead folks over at DHS, the NIH, the Veterans Administration, really all that federal health component, is better than its ever been.

We have some coordinating groups at work. Do we need to do more? Yes. Because the problem is that different people own different pieces. And it's an issue that goes across all the federal government, really on a number of issues. How do you coordinate all that? What is the coordinating mechanism?

We now have the Homeland Security Council whose really been an important driver in getting all the departments together to work on this. But now it needs to go beyond that to state and local.

And there really is federal, state and local. And that conversation has started. It's got a long ways to go. I agree with what Jeff was saying, and Susan.

MR. LEVI (?): I think there are two points, slightly different, but important to make. One is, I have no doubt that the federal agencies are talking with one another, and certainly are talking with one another much more than they were before.

But we saw in Katrina fundamental breakdown in the supply chain of medicine, so that people in the Astrodome were not getting their blood pressure medicines, their insulin, very basic medicines. Where this was a matter of the drugs and the medicines were available, we just needed to get to a place.

And we didn't have enough supplies stockpiled. We didn't have it in the right place.

In a pandemic, if the economy is disrupted and the supply chain is disrupted, we are going to see every community in the country having shortages of just routine medicine.

And if we don't get (ahead ?) system for stockpiling them and distributing them, then we're going to see not just the added burden on the health care system of a pandemic, but of other chronic diseases that will also be exacerbated.

But I'd also like to come back to your earlier question about the planning and whether we're doing enough of that.

You know, it's probably my role to always say the government is not going to be doing this.

MR. WINKENWERDER (?): That's why you're here.

MR. LEVI (?): That's why I'm here. But there are also some very minimal things that could be done, even before the detailed plans are in place.

For example, there has yet to be a communication from the federal government to businesses about contingency planning or just letting them know that this is an issue that they need to pay attention to.

The U.K. did this I think over a year ago now. Other countries have been able to do that. And this is going to be shameless self promotion here, but our organization recognized this problem. We created a brochure for businesses. It's called Not The Flu As Usual, just to explain what the difference is.

And there are copies out at the reception desk for people here to get. But that's a simple exercise.

Now, I know in government putting out a brochure probably takes months and clearance processes. But nevertheless, if the U.K. did it over a year ago, by now the U.S. should have been able to do that.

We haven't been talking to -- you know, the education department, I don't know if they are part of the planning process.

MR. WINKENWERDER (?): Yes, they are.

MR. LEVI (?): What's going to happen with schools? When do we shut them down? What are we telling universities? How are they planning? When there is an outbreak in the dormitory, do you isolate, do you quarantine, do you send people home? What do you do?

These are things that people should be planning for so that there isn't panic when the event occurs. And we don't have to have worked out all the details to at least be starting to alert people about what needs to be done.

And that's where I think it's most disappointing, because that doesn't even take resources. It really just means posting something on the web so that people who ultimately need to implement it can go about their business and prepare.

ADMIRAL BLUMENTHAL: And let me just say, too, I am a big supporter of government. I've served in government for 20 years, and I believe in the power of good government. After all, as I said, we live 30 extra years. We have safe food, safe water, in our country, safe roads, transportation, environmental -- all of these things are because of government interventions.

But I think that when government works well with the private sector, as you're suggesting, when we really take it seriously and also have accountability in terms of where our dollars are going, and bring into this to look at that plan, and help to put flesh on its bones.

I think we can see an effective response. We need to move quickly to accelerate and translate what we know, to improve what we do. There is a 15 year science-to-service gap between the time of a new discovery and its wide deployment in the community. In the information age, why shouldn't it be 15 seconds?

And I think that, again, after 9/11 we established what is called AmericaCorps, which mobilized volunteers in various sectors of our society -- health professionals, educators, people who wanted to help after 9/11, but they didn't know where to go or weren't credentialed to do so.

In communities we need a volunteer corps, people who are prepared to respond. We need guidance for schools and businesses and individuals about what they should do.

And again, as I said earlier, it is important to start rehearsing this. You can't put a show on without a dress rehearsal. So that everyone feels empowered, because there will be mass panic, and people will not make the right decisions unless there is a wide-based community discussion and rehearsing of the various options while we're waiting to get a widespread vaccine and anti-viral medications.

Additionally, we must bring the veterinarian community to the table. There needs to be a lot of discussion today and in the future between these two communities, because infectious diseases have always been decisive shapers of history throughout time, and they will continue to be, as human beings create new technology, change the environment, and the environment then impacts our health.

Forty new diseases have emerged since 1970, and we didn't even think about them until anthrax and then SARS. But diseases like AIDS, Ebola, Lyme disease, monkeypox, SARS, they've all emerged in the past 30 years.

And again, we must keep emerging and re-emerging diseases at the front burner of our national health and international health care agenda.

And lastly, as part of this plan, we have to put more emphasis on the international piece, because many of the diseases start in countries where animals and humans live in close proximity. And if we can stop the disease where it starts, we have a better chance in an era of international trade and travel, where two million people cross national borders, then there's hope that these diseases won't come to our shores.

ROSS: You've been involved in some exercises; they're beginning. What does the government do in the first 24 hours after there appears to be a flu outbreak, and how do you define the outbreak? When do you push the button that this is it?

MR. WINKENWERDER (?): Well, I'm not sure that I actually agree with your assumption about -- there is a 24-hour window --

ROSS: What happens in those first 24 hours?

MR. WINKENWERDER (?): My own personal view is that it may be more difficult than just saying, hey, we've got human-to-human transmission. I think we'll likely be dealing with a period of significant uncertainty --

ROSS: For how long?

MR. WINKENWERDER (?): Days, weeks, could be, before we know the extent of any kind of human-to-human transmission.

(Cross talk.)

MR. WINKENWERDER (?): Well, to me what would be the most concerning would be evidence that someone stepped on an airplane one place and you suddenly found H5N1 here when you're going assumption is we're just dealing with it here.

ROSS: At that point is it unstoppable?

MR. LEVI (?): No, I don't think it's unstoppable. But the strategy is to slow, to mitigate, to stop it if possible. But everyone has already spoken here, the science community has spoken about the difficulty if there are sparks, if you will, that ignite embers in multiple places, it will be very difficult to stop.

So then the important thing in my mind becomes the communications -- the accurate communications -- the appropriate response of individuals, private sector, of everybody involved, the governments sharing information, everything we talked about.

ROSS: You recall when anthrax broke out, the first description was that this perhaps was due to some fungus in a stream -- a far-fetched explanation; couldn't possibly be what it was.

MR. : That wasn't helpful.

ROSS: That wasn't helpful. How do you avoid giving that same sort of reassuring false --

MR. WINKENWERDER (?): Well, one of the things -- many people here have probably read John Berry's (ph) book, but one of the things that struck me in reading that book is the degree to which public officials went to try to -- don't panic, don't panic, don't panic.

Well, it turns out, it may not have been particularly helpful. What people want to hear is, what do I need to do. Tell me what I need to do. The amount of fear I should have -- (inaudible).

And that's what we need to do -- be straight. Give people the facts. Tell them as best we can what they need to know, and tell them often.

ROSS: Who would do that on a national level? Who would be in front of the camera?

MR. WINKENWERDER (?): Well, I think the director of the CDC, obviously, is a very credible person, an expert. Dr. Gerberding, she and I have worked together very closely -- Tony Fauci from the NIH, Secretary Leavitt. Secretary General Carmona will be speaking to and for the military.

And so -- and there will be others. There are experts here obviously. What does this mean? The media, I'm sure, are going to talk to others, to reference and cross reference the accuracy of what all of us might be saying.

So -- and there shouldn't just be a single voice. I mean people are going to turn to their individual physicians. They are going to turn to their local community leaders.

And that is why, working off of accurate information is so important.

ROSS: I think it's time to go to some questions for the audience. I'd ask you each, there are microphones here, if you'd just state your name and affiliation.

We also have a group in Washington watching, and we'll start there. Susan, are there some questions from Washington to begin with?

MS. SUSAN DENTZER: Yes, I think there are, Brian, thank you. And let me start by asking Dr. Winkenwerder, the DOD has played a major role in vaccine research and development as well through usamarin (ph). And you hear some of the earlier discussion about use of adjuvants, new delivery mechanisms under investigation, how much it is realistic to think we could build a large production capacity fast, as well as extending the existing production capacity.

What is the -- is there an emerging perspective from DOD on this on what would be realistic goals for vaccine production delivery capacity, et cetera?

WINKENWERDER: Susan, thanks for asking that question or bringing that whole issue up.

Over the past three years we have made a significant leap in our focus on an investment in this whole area. I can remember just prior coming to the Department of Defense there were voices in the health community who were saying, you are way overblowing this business of infectious disease or bioterror threats. We don't need all this investment.

Where we are today is on the infrastructure side like the discussion that was talked about earlier on the cell-based technology for vaccines is, we have a $2 billion investment plan literally for the facilities to be able to conduct infectious disease research there at the Ft. Detrick campus.

In fact, what is being built is a national biodefense campus. And I say that because the Department of Homeland Security is there. The National Institute for Allergy and Infectious Disease is there. The National Cancer Institute is there. And the CDC hopefully will be there as well.

And so this we hope will be a test bed set of facilities to really assist with rapid development of needed vaccines. There is a fair track record, not the track record I'd like to see in terms of that institution and its work.

The institution was very important in developing the recombinant protective antigen anthrax vaccine that we have today that will be the new -- so-called new anthrax vaccine. It involved a smallpox vaccine. In ebola, there is some very encouraging work with respect to ebola vaccine.

But the bottom line is, just need to be, again, an interagency effort. The investment is coming.

But I think we're all anxious to see products be turned out more quickly. And we can't do this alone. It's really, I think, got to be done in conjunction with the private sector.

There is a lot of latent capacity -- latent, I think, is probably a fair word -- capacity within the pharmaceutical industry to assist in the development of some of these products. They have to see that the money is there, and in some cases that there is liability protection before they leap headstrong into this area.

MR. LEVI (?): You said the big word, liability. There certainly is liability legislation moving in Congress. But I think it's also important to point out that we also need to deal with the compensation side.

The reason industry wants liability protection is, they recognize there may well be side-effects. And in the context of a pandemic vaccine we will probably not have tested it as well. We may be doing it somewhat differently, and there may be injuries to people, and we need to assure that people get compensation as well.

We saw through the smallpox vaccination effort how that was a tremendous impediment to broad-based vaccination.

QUESTIONER: Given that we're talking about high consequence zoonotic agents, I'd like to mention and bring up the fact that there is already a testbed for taking an agent-based approach to zoonotic threats versus an agency-based approach, which is what we continue to use.

And the Department of Defense has taken a very innovative approach in the former Soviet Union. The Defense Threat Reduction Agency is spending hundreds of millions of dollars on essentially reestablishing the former Soviet anti-plague system.

Now, from the people who brought you biowarfare, they have always taken a very different approach to real-time detection of zoonotic threats both in the human and in the animal sector. All groups reported to a centralized agency called the anti-plague service. And we are now working to essentially reestablish that.

For people who aren't aware of it, perhaps the DOD could share some of the information on the headway they're making in that area, because it might very well serve as a new paradigm for how we approach these rapidly spreading zoonotic agents.

WINKENWERDER: I'll take that message back. DTRA is not part of my organization, but we do work with them on things, so thank you for making that point.

ROSS: Yes, sir. State your name and where you are from.

QUESTIONER: I'm Tom Vernon, a former health director in Colorado.

Among the many dilemmas that will cause potentially an erosion of our sense of community will be obviously priority about first doses of vaccine. This -- not vaccine, but it certainly happened in Philadelphia in 1918 as described by John Berry. It's a horrible story.

I bring this to you, Dr. Winkenwerder, about who gets the first doses of vaccine. In tier one, subtier A of the plan, there are about 18 million health care workers who have direct patient contact. In the first week of vaccine availability there are -- expects to be, perhaps, at least in the short term, about five million doses.

What argument would you make that 1-1/2 million of those 5 million should first be used among the military?

WINKENWERDER: Well, let me just say and clarify for the record here, we in the military placed an order by agreement with the Department of Health and Human Services have set aside, if you will, about 2.7 million doses of the H5N1 preparation that is based on isolates from Vietnam -- the NIH-developed vaccine.

And we will begin to receive delivery on that later in 2006, in the spring of 2006.

So we are already there, so to speak, with respect to that allotment. There are several millions of additional doses that the Department of Health and Human Services has. I don't have the exact number. But by agreement we've worked together to share literally share stockpiles so that the strategic national stockpile is potentially something we could contribute to out of our inventory of supplies and materials, and likewise, if we needed to draw on that to support the military, we would certainly do so.

ROSS: The question is, why do you get it first?

WINKENWERDER: Well, I think -- well, I think we do because we are a critical national security capability and asset.

ROSS: Aren't also the doctors and nurses at the local hospitals?

WINKENWERDER: Well, they are.

(Cross talk.)

WINKENWERDER: I think it would be a mistake for anyone to assume that at the first moment's notice of a cluster of evidence of human-to-human transmission that we are going to run out and use that entire stockpile to vaccinate people.

I don't anticipate that. Our effort will be to target whatever vaccine initially -- to target whatever vaccine and antiviral medication we have in a way that it can be most useful around and surrounding the event.

Now, beyond that, we are working through a -- (inaudible) -- scheme which, at or near the top -- of course there are our own health care workers, but also our deployed forces in Iraq and Afghanistan. If we cannot continue the mission there, that obviously would be a pretty dire situation. We don't want to be in that situation.

And, of course, everyone, I think, probably also knows, military being concentrated in camps and barracks and so forth, is a high-risk environment, putting that many people together.

(Cross talk.)

WINKENWERDER: It really wasn't the Spanish flu. It was an American flu that by all lights started within the U.S. military.

ROSS: And do you think that U.S. soldiers might, in fact, be the agent to spread this disease?

WINKENWERDER: My goal would be that they would absolutely not be.

ROSS: But you're concerned about that?

WINKENWERDER: We've got to be concerned about that and be prepared to stop that.

ROSS: You are prepared to stop movement of troops?

WINKENWERDER: Oh, absolutely. And we did in the case of SARS. We didn't allow ships to board at the peak of that event at certain places that we thought that they might become vectors.

MR. LEVI (?): Brian, I think another point to make on this is, this is part of the public engagement that needs to happen before there is a pandemic. And the National Vaccine Advisory Committee priorities that Dr. Vernon mentioned were one exercise in that regard.

HHS actually supported a public -- a series of public engagement exercises, one of which I participated in. And when you talk to, whether they are stakeholders or average citizens, to the degree that you ever get an average citizen in a room, if you talk through what we know about a pandemic, what needs to happen in a pandemic, people generally come up with very similar priorities.

If we engage the public in understanding how we got to that prioritization, probably they may be disappointed; they may be angry that we don't have enough for everyone. But they will at least intellectually understand how we got there.

It's not engaging people and just saying, this is how we're going to do it. That, I think, is more likely to result in a negative response.

ROSS: Another question? Yes, ma'am.

QUESTIONER: I'm -- (inaudible) -- from Becken-Dickinson (ph). BD is a medical devices and diagnostics company. A point was rightly made at a previous panel discussion on the need to stockpile and plan for medical equipment, the syringes along with vaccines. BD supports that talk. I'd like to know, is there a plan in your national strategy to stockpile syringes along with the vaccine doses, and if so, what is it? Because in my opinion if you have vaccines without the right devices, then it's like having the software without the hardware. Or if you have to use a war analogy, it's like having the bullets without the guns.

WINKENWERDER: That's an excellent point. And I can only with confidence speak precisely about the U.S. military. We are accumulating stockpiles of those kinds of materials -- masks, syringes, et cetera -- on the civilian side within the strategic national stockpile maintained by Centers for Disease Control.

I would expect that that is part of their planning and thinking.

BLUMENTHAL: It is. The strategic stockpiles in various geographic areas of the country do contain other medical supplies. But again, talking about the number of supplies that we have, if a pandemic were to affect our country, there are not enough supplies yet for such an event.

But again, as Louis Pasteur said, "chance favors the prepare mind." And so I think because of the kinds of dialogue that is going on now in our country, long overdue, we are going to start to anticipate these kinds of issues, and try to gear up manufacturing on all of the issues that will impact the pandemic and its control and prevention.

ROSS: Yes, in the back. Yes, sir. If you could stand up, and say your name.

QUESTIONER: Richard Webb, and I write. Was Homeland Security informed of this conference and invited to send a representative?

ROSS: I don't know the answer to that.

QUESTIONER: Was the agency, the lead agency?

MS. LAURIE GARRETT: (Off mike.) Many invitations were sent to a broad range of federal representatives but were largely declined.

ROSS: A very diplomatic answer.

QUESTIONER: I spent 35 years in Washington. A lead agency with billions of dollars to spend usually defends its turf and priority. And the absence of Homeland Security gives me an impression that either they are not informed -- somebody has not told them that they are the lead agency -- or they're not sure, they're not exactly sure what they should do? Am I incorrect?

WINKENWERDER: Sir, let me -- I don't think that is a fair characterization. I'm not going to speak for a sister agency that is not here today. It would certainly be nice if they were.

But they are well informed on this issue. And I think hopefully you were listening earlier when we spoke about the fact that they are a lead coordinating agency, not the lead response. The lead response agency is the Department of Health and Human Services.

Obviously this is a public health issue. It's a medical issue. And that is where the massive amount of work has been done.

The Department of Homeland Security has been very involved in all of this, including the Homeland Security Council. So I don't know -- obviously I don't know where people are today. It'd be great if they were here.

And also I think, in fairness, the recommendation that pandemic flu would be a major security challenge and probably would stress our system more than almost any other threat is something that Homeland Security has recognized for some time. In fact, pandemic flu is one of the leading sort of horrible scenarios that they have been focusing in, primarily because, unlike most bioterrorist threats, this would be truly national and international in nature, whereas whether it's a dirty bomb, or even a smallpox attack or something like that, the assumptions are that it would not be affecting the entire country at exactly the same time.

And so in that regard I think there is a recognition of the seriousness of the problem.

BLUMENTHAL: And I think pandemic flu has kept public health officials and Homeland Security officials up at night for some time. But I think now that all these forces are being mobilized, it's very important to have transparency, and, you know, complacency is the enemy of preparedness.

And so I think maybe it's one of our recommendations coming out of a meeting like this that we encourage our agencies to send representation to these meetings. There will be more and more of them as the public wakes up and as various businesses wake up to the seriousness of this public health threat.

And I think that we need to have their very important perspective at the table.

MR. LEVI (?): Let me just say one other thing. I want to commend the Council for having this. This is a very important event, and I think it's wonderful. But all of you are here today, this is being webcast, people are learning, it just makes a point, at least for me, that it's not just -- we're all counting on the government to be leaders and to respond appropriately in this situation.

But there are many other parties that can play a critical role, and this is really important.

ROSS: We have time for just one or two more questions. I hope they're tough ones.

QUESTIONER: Hi, I'm Brit Buyers (ph) from Kleiner-Perkins.

There has been no discussion of government's role in innovation here. And Jeffrey, to you, then, in these bills -- the president's proposed or bills in the Senate -- what role has innovation in that? Hasn't that usually come through the NIH? And I haven't heard any talk about NIAID this morning.

LEVI: Within the president's vaccine development program -- and I wish there were some scientists here who could speak a little more precisely -- it is not to increase our capacity using current technologies, but both moving to a cell-based technology, but also supporting additional research to get us to sort of the holy grail of a flu vaccine, which would be applicable to almost any strain.

Whether that is achievable or not remains to be seen. But there is the beginning of investment in that direction.

So I think it's important, and I think that's to some degree what makes the vaccine part of the president's initiative so important and unusual is that it is not just going down the traditional paths. It is really saying, we are committed to developing new technologies and not just doing the scientific discovery part of it, but also building the infrastructure and the capacity to produce those two technologies.

BLUMENTHAL: I just wanted -- in my remarks earlier I had said that one of the components was to accelerate the scientific base. And I think it is critical, because right now we're using vaccines that were made in the '60s. And I was at that meeting on avian flu when we had Kleiner-Perkins was there along with other businesses, scientists, public health officials and others from diverse fields to try to acceleration innovation not only in science but in public health preparedness.

We have to move forward -- and hopefully our huge investments, whether it's in biological threats or pandemic flu, will pay a dual dividends, to protect us from any flu that might affect us in the future, but also from other major killers. They kill millions of people every year, like AIDS, like malaria.

And again, this dual dividend notion, I think, is a critical one to put on the table.

ROSS: Let's go to Washington for a question. Susan.


I'll just make a brief operation and solicit response about the coordination and lead agency issue. I was just very struck by the fact that both DHS and HHS have sort of bookended worst-case, best-case scenarios for pandemic flu, and if you look at their numbers, the DHS worst-case scenario corresponds to the HHS best-case scenario, and the HHS worst-case scenario is an order of magnitude worse than that of DHS.

And I'm just wondering what level of confidence that would inspire about all these agencies down the pike.

WINKENWERDER: Variation in scientific opinion, I'm sure, is the explanation for that. I honestly don't know why people have come to different numbers. My guess is that that difference will be resolved.

ROSS: We have time for one final question here. Let's see, yes, ma'am.

QUESTIONER: Betsy Williams from the Asia Society.

And my question is, we've talked a lot about the different partners who will need to be mobilized, and there has been some reference to civil society more broadly. But I wonder if you could just address that and how government and private sector should move forward in working with civil society.


MR. LEVI (?): I think the short answer is that civil society will be bearing the greatest -- in some degree, the greatest burden of a pandemic and will have to be brought into and engaged in the development of a response.

How the economy will continue, how businesses plan, is one element of it. Another is, we have essentially a predominantly private health care system. Even when people have public financing the delivery of their health care is through a private system -- very different than countries in Europe, who have a much simpler process to go through.

So whether it's the health care system, businesses, or engaging the general public, in the dialogue about what this is going to mean and how our society is going to function, these are all critical components. It's something that we only occasionally do on various issues, including public health. But this is the sort of thing, especially given that we will not have the traditional biomedical interventions that people look to public health to provide in a crisis.

We won't have those, so we have to start engaging people in having those conversations.

ROSS: And finally, let me ask each of you to give us a sense in 15 or 30 seconds, what can we expect in the next two years? Is it inevitable from your point of view, in your planning? Do you see it that way?

MR. WINKENWERDER (?): I'm not enough of an expert to make that prediction; I'm really not. I would turn to people like Dr. Webster.

ROSS: In your planning.

WINKENWERDER: I think we have to plan for that possibility. And so that means full speed ahead. And that is the level of seriousness with which in my judgment the entire federal government is taking this issue. It certainly is where we are at the Department of Defense.

BLUMENTHAL: Again, I agree. I don't know that we know that it is inevitable, but there are some very serious warning signs.

I think if you look at SARS, there is hope. Again, it didn't have the lethality of avian flu. But because of deploying the weapons of public health—epidemiology, containment, social distancing—we were able to prevent the further spread of that problem.

This is different, but again, I think if all sectors of society work together and come together, bringing the best of science and technology, marrying them with the public health lessons of the past, we can respond.

But I hope it's soon enough.

ROSS: And Jeff?

LEVI: Plan for the worst, hope for the best. And recognize that this is not a short-term investment; that the level of preparedness that we need to respond to pandemic flu is very familiar to various other kinds of threats that we face in the public health arena, whether they are man-made, or they are found in nature.

And so this is an opportunity not to just be well prepared for pandemic influenza, but to have a much stronger and vital public health system.

ROSS: Well, thank you all three. We didn't get all the questions answered, but at least we know what we don't know, and sometimes, that can be helpful.

Thank you very much.







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