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Hearing of the Ad Hoc Subcommittee on State, Local, and Private Sector Preparedness and Integration of the Senate Homeland Security and Governmental Affairs Committee - Pandemic Flu: Closing the Gaps

Hearing

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Location: Washington, DC

SEN. PRYOR: (Sounds gavel.) I'll go and call our meeting to order here. I want to thank everyone for being here today. And this is the subcommittee on State, Local, and Private Sector Preparedness and Integration. And it's time for us to update our efforts on pandemic influenza.

The CDC has described pandemic flu as both inevitable and one of the biggest threats to public health in the nation. In October 2007, we -- I chaired a hearing titled, "Pandemic Influenza: State and Local Efforts to Prepare." At that hearing HHS, DHS, and state and local health officials testified. The witnesses cited efforts underway that included national strategies, plans, and exercises.

Now, less than two years later, we're faced with the reality of a pandemic threat. In late March and early April of 2009 the first cases of a new flu virus, the H1N1 were reported in Southern California and San Antonio, Texas.

So far the CDC has confirmed 10,053 cases in 50 states, and in the District of Columbia. This includes seven cases in my home state of Arkansas. The CDC reports that most of the influenza viruses being detected now in the United States are of this strain.

Further, CDC's Dr. Anne Schuchat has said this will be a marathon and not a sprint. And even if this outbreak is a small one, we can anticipate that we may have subsequent or follow-up outbreak several months later and we need to stay ready.

And one of the things we've talked about in the subcommittee before is with hurricane preparedness. Years ago there was an exercise authorized, and then for whatever reason FEMA or the Congress for whatever reason, the money wasn't there to go to prepare for this Hurricane Pam exercise that was exactly the scenario that happened when Katrina happened.

And I want to say they maybe did part of the exercise, but they didn't do the follow-up, and the -- you know, it wasn't implemented. The lessons learned were not implemented. And we saw what happened recently with Katrina.

And we found ourselves today in a somewhat of a similar situation in that. We've had this flu scare already, this spring. And now it looks like, you know, if flu behaves like it normally does we'll have a few months here where it won't be that active and then -- I hope I'm wrong -- but it looks like it may come back in the fall.

And, you know, we just need to make sure that we're ready, that we're doing everything that we can do. And that the state, local, private sector, everybody is working together on this.

So what I'd like to do is introduce the panel and ask each of you to make a five-minute statement. We may be joined by some other senators. Senator Ensign has been trying to change his schedule to get here, and a couple of others.

But what we'll do is we'll keep the record open. And after the conclusion of the hearing we'll keep it open for a couple of weeks and let senators ask questions. And if there is follow ups that we need to work with you on, we'll do that.

So let me go ahead and introduce the panel. And first we have Bernice Steinhardt. And she is director of the Government Accountability Office's Governmentwide Management Issues. Am I saying that right?

And she has led the preparation of 11 GAO reports. The most recent, Sustaining Focus on the Nation's Planning and Preparedness Efforts, basically synthesizes 23 recommendations that we should be working on now. Ten of them have yet to be acted on.

Our second panelist will be John -- is it Thomasian?

MR. THOMASIAN: Thomasian.

SEN. PRYOR: Thomasian. John Thomasian. And he is the director of the NGA's Center for Best Practices.

And next we'll have Dr. Paul Jarris. And Dr. Jarris is the executive director of the Association of State and Territorial Health Officials.

And finally, we'll have Doctor -- is it Ostroff?

DR. OSTROFF: Ostroff.

SEN. PRYOR: Ostroff. Dr. Ostroff is the acting physician general and director of the Bureau of Epidemiology for the Pennsylvania Department of Health.

So what I'd like to do is just open it up, five minutes each, and then we'll ask questions. Go ahead.

MS. STEINHARDT: Thank you very much, Senator Pryor. I really appreciate the chance to be here today.

I wanted to talk to you about the report that you mentioned a moment ago, that we issued actually in this past February, which synthesized the results of close to a dozen reports that we've issued since 2006. And in that February report we pointed out that despite the economic crisis and other national priorities that had become top priorities for the country, a pandemic influenza is still a very real threat and requires continued leadership attention.

When the H1N1 virus emerged two months later, that warning was dramatically underscored. Before I go into the findings of our reports I want first just to acknowledge the important progress that we've made in the last few years.

In addition to the national pandemic strategy and implementation plan that was developed by the federal government, all 50 states and the District of Columbia now have pandemic plans, as do many local governments and private companies. And we have clearly benefited from all of this planning.

But that said, there are still some significant gaps in our planning and preparedness. For one thing, the leadership roles in a pandemic, the who is in charge question, have not been clearly worked out and tested.

Under the national pandemic plan, the secretaries of Health and Human Services, and the secretary of Homeland Security are supposed to share leadership responsibilities along with a system of federal coordinating officials and also principal federal officials and the FEMA administrator.

And all of these positions may be vital in a pandemic, but how they will work together has not been tested yet. So in 2007 we recommended that HHS and DHS work together to develop and conduct national tests and exercises. And the departments agreed with our recommendation.

But since that time there still has not been a national exercise for this purpose. And now that we have new people filling some of these leadership positions, the need to clarify these relationships in practice is only heightened.

Beyond the lack of clarity on leadership roles, the national strategy and plan have a number of other missing pieces, and I'll mention just a couple.

First of all, key stakeholders like state, and local, and tribal governments were not directly involved in developing the plan even though the plan relies on them in a number of instances to carry out some key elements of the plan.

Secondly, there were no mechanisms described in the plan for updating the plan and reporting on its progress. And this issue of updating the plan is particularly timely since this is a three-year plan, and it was developed in May of 2006.

To fill these gaps we recommended that the Homeland Security Council establish a process for updating the plan that would first of all involve key stakeholders, and incorporate lessons learned from exercises and other sources.

We made that recommendation in 2007. But the Homeland Security Council didn't comment on it, nor did they indicate whether they would act on it. But I would say that it is especially pertinent today as we try to learn from the experiences of the H1N1 outbreak.

As we go forward, it's also essential for the Federal Government to share its expertise and coordinate its decisions with other levels of government and the private sector. A number of mechanisms were developed for these purposes. But they could be used even more. And I'll mention one example.

In the 2008 report that we did on state and local pandemic planning, we pointed out that an HHS-led assessment of state plans found many major gaps in 16 of 22 priority areas that included policies related to school closures and community containment.

And at that same time, a number of the state and local officials that we were talking to told us that they would welcome additional guidance from the federal government in these same areas. And I know National Governors Association found many of the same kinds of issues.

DHS and HHS at that time had earlier convened a series of regional workshops with state officials to help them with their planning efforts. And we thought that the two departments could use additional workshops to help states address the gaps in their pandemic plans. The two departments, HHS and DHS, agreed with our recommendation. But they haven't held any additional meeting since then.

In closing, I just want to point out the importance that -- to bear in mind, that while the current H1N1 outbreaks seem to have been relatively mild, the virus could return, as you pointed out, Senator. It could return. It could return in a second wave this fall or winter in a more virulent form.

So given this risk, the administration and federal agencies should be turning their attention to filling some of the gaps that our work has pointed out while time is still on our side.

Thanks very much.

SEN. PRYOR: Thank you.

Mr. Thomasian.

MR. THOMASIAN: Thank you, Mr. Chairman. As you pointed out, my name is John Thomasian, and I direct the center -- National Governors Center -- Association, Center for Best Practices. And I appreciate the opportunity to testify before you today on pandemic influenza and how we can close potential gaps in our capacity to respond.

My comments today are based on the work we have done over the past several years with the states on pandemic planning that began in 2006 with a governors' guide. It included training workshops, nine regional training workshops for all 50 states and 4 territories in 2007 and 2008. And our work continues today as we assist the Governors Homeland Security Advisors and respond to the recent outbreak.

We're going to focus on five key areas very quickly; information sharing, interagency coordination, school closings, continuity of government and coordination with the private sector, and communication with the public. Each of these were identified as problems in our previous work. And I will discuss how each of them were handled in the current outbreak.

Information sharing. Information sharing during the recent flu event demonstrated that systems worked much better than we anticipated. The flow of information between the federal government and the states was nearly constant during the initial weeks of the outbreak. And case counts were updated daily. Morbidity and mortality figures were readily available.

And the federal government did a good job pushing information down to state and local government. That being said, there is room for improvement. Both CDC and DHS began to hold independent daily briefings for state officials in the early weeks. These briefings often contained the same information, and often contained the same federal officials.

But states were never sure if all the information was new. So they put time aside for all the briefings. As a result, state officials spent several hours each day monitoring conference calls instead of response activities. In the future, DHS and CDC should hold a single daily briefing with states on all essential information.

Interagency coordination. When we held our workshops in 2007 and 2008 many state teams were meeting for the first time. They were not clear on their own responsibilities, much less those of their federal counterparts.

Three years later, in addition -- with additional planning and exercises, the situation has improved. I think the Centers for Disease Control and Department of Homeland Security worked well together during the recent outbreak, and provided a relatively seamless portal to federal resources and technical assistance.

At the state level homeland security agencies began coordinating immediately with their health departments, and many states enacted emergency declarations and other orders to begin mobilizing broader state resources if needed.

Looking ahead, we must recognize that good interagency coordination deteriorates without practice. To maintain performance states must be given encouragement and resources to conduct preparedness exercises with multiple agencies and levels of government. This is a capacity that will go away over time.

School closures. School closure policy was a topic of intense discussion at each of our national workshops with little consistency and approach. It was not a surprise therefore when the recent outbreak led to a patchwork to school closure decisions.

One issue was that the Centers for Disease Control's written guidance suggested that closure should be based on laboratory confirmed cases, while public comments by some federal officials suggested decisions should be based on suspected or probable cases, or when students had a family member with the disease.

Also missing was advice to patents and students on actions to be taken outside of the classroom to limit the spread of the disease. In many cases dismissed students simply re-congregated at shopping malls or other venues to share potential infections.

More precise advice will be needed from CDC in the future to help states and districts implement a more consistent approach to school closure. Guidance should also address prevention actions beyond school grounds.

Continuity of government and coordination with the private sector on critical services. In our workshops we ask states to envision a rate of absenteeism that could approach 40 percent. To cope with this possibility, states needed to develop detailed continuity-of- government plans and work with the private sector to ensure the availability of critical goods and services.

This mild outbreak simply did not test these contingencies. They remain among the unknowns of our preparedness and should be revisited before we enter the next flu season.

Finally, communication with the public. In the recent outbreak, government and the media did a good informing the public on the spread of the disease and what individuals should do to avoid infection.

However, the federal government did not adequately explain the type of response options they had at their disposal, what was being considered or rejected, and why. This led to a great deal of confusion in the early stages regarding what might happen next.

To address this gap, the public must be given information on the appropriateness and the implications of specific actions such as quarantine, social distancing, travel bans, school closings, and the use of personal protective equipment.

In conclusion, the spring outbreak has so far resulted in less than 9,000 confirmed cases nationwide. In contrast we must remember that a severe pandemic will produce tens of millions of infections. Before the onset of the next influenza season we should take the time to address the weakness in this initial outbreak exposed.

We should clarify the guidance on school closures to ensure consistency. Information exchange should be improved so that responders can allocate their time more efficiently. The public must be educated on the benefits and cause of mitigation strategies. And states should be encouraged and supported to conduct periodic pandemic exercises with federal agencies, local governments, and the private sector.

Thank you, Mr. Chairman. I'm pleased to answer any questions later.

SEN. PRYOR: Thank you.

Dr. Jarris.

DR. JARRIS: Mr. Chairman, thank you for the opportunity to speak.

I would like to make a couple of points that have not been made before. One is that this is not over. We still have an outbreak and an epidemic going on in this country. And just over the last day the cases have increased to 11,000, which is a tremendous undercount.

And in your state of Arkansas it's now nine rather than seven. You've been relatively spared. But other states have been hit much harder, including New York. And currently Massachusetts has a dramatic outbreak ongoing.

So this has never gone away. It's really not a matter of if it comes back in the fall. It hasn't left yet. The question will be, when it comes back in the fall will it have evolved to a more severe pandemic or epidemic than the epidemic we're having right now.

Furthermore, it's just -- it's not just another seasonal flu as we hear people saying. This is not the time of year you have a flu outbreak. That is one of the ways we search for new viruses and find them.

Secondly, this is primarily young people being affected. The average age of individuals being affected is between 11 and 19 years old. The average age of some in the intensive care unit is 23 years old. And the average death rate is in the 40s.

That is not seasonal influenza which largely affects the elderly and otherwise people with immune compromise. So this is a novel virus. And what we have to understand is we do not know how this is going to behave. In 1918, at this time, it was behaving very similar to this.

Now, whether or not it will come back as severe a category four or five in the fall, we simply don't know. But the prudent thing is to plan for a range of an outbreak consistent with what we have now all the way to a severe pandemic worldwide.

The World Health Organization is right now considering whether to raise it to a pandemic level 6. But frankly that is not that important at this country, because we already have an epidemic ongoing. Pandemic just means the epidemic is spread around the world. We have it already.

The response to date, I believe has been a good response. The federal government, state government and local governments have acted in concert with each other and as a national government response.

Harvard did a study which showed 80 percent of the Americans were satisfied with the response, 88 percent were satisfied with the information they were getting. That was a result, not only of the federal government giving us guidance, but the state public health officials and Homeland Security officials going back to the federal government to say here is what's happening on the ground and giving them situational awareness.

We also have learned that there is much to be done with our planning. There were many assumptions made, which proved not to be true. There were many planning -- plans that were made which were not nearly granular enough. So now that we're in a response much more so than just a drill, we have learned about the shortcomings in our planning and what has to be happening.

We have now a window of 12 to 16 weeks before this thing would escalate as the 1918 virus did, before the return of the seasonal influenza, which will come on top of this current influenza outbreak.

The reason I say it's not scalable, there has been about a 25 percent cut in state and local emergency preparedness funding. Over the last several years we have had about a 20 to 25 percent cut in hospital preparedness money. And the single appropriation of pandemic influenza funding in 2006 was completely spent by August of '08.

There is no money from the federal government to state and local government and public health to respond and plan for the fall. And we simply have no alternative. So we must take care of this window of -- take advantage of this window of opportunity now to protect the American people.

And let me give you the orders of magnitude here, because frankly, I think we're all having a little bit of sticker shock when we think about what it will take to respond and protect the American people. For one, we are asking for $350 million. Another bull (ph) is, if you will, the planning money to carry the state and local governments not only through the response right now, but to plan and work on transitioning from planning to implementation for the fall.

But importantly there has been much talk about vaccine, the single most effective thing we can do to protect our population. Our plans call for protecting the entire U.S. population, that's 300 million people. We do believe that it will be two doses per person. By the time we know different, it's too late to produce the extra doses. So if conservatively that's $5 per dose, we're talking about $6 billion just to buy the vaccine.

Now, vaccine isn't a good luck charm. It has to be given to people. We can give you the numbers and the information. But conservatively it's $15 a dose to provide vaccine, you know, the government-run program.

That's less than the private sector. But much of the workforce giving this will be private sector. So we're talking about $15 billion to give those 600 doses. So just there alone we're in the ($)14 (billion) to $15 billion range.

So we really have to come to grips very rapidly with how seriously are we as a nation in protecting the people of the United States. And will we make those resources available now, or will we stare the American people in the eye come the fall and say when we had an opportunity we didn't do it.

Thank you, sir.

SEN. PRYOR: Mr. Ostroff.

DR. OSTROFF: Thank you, Senator.

Influenza is unquestionably one of the most unpredictable public health issues we face. Just when you think you understand what's going on it always throws you a curve ball. For several years we've been focused on the emerging threat of bird flu in Asia. And rightly so it's highly lethal, it's continuously circulated for six years, and it has devastating consequences for agriculture.

Most of our planning assumptions have been based on a scenario that a pandemic would start in Asia, that it would be noticed there, and that we could delay its introduction and spread. And then out of nowhere a new virus lands right on our doorstep, isn't noticed until it's already here, and renders many of our planning assumptions irrelevant.

Fortunately, so far its public health impact, as measured by illness and death, has been modest. But its overall impact has been anything but. It's caused tremendous disruption to individuals, families, schools, and communities. And we don't know what the future holds for this virus.

Like the other states, we in Pennsylvania immediately ramped up our disease monitoring and response as soon as we learned of this new flu strain. Over the last two months, despite the fact that we've not had that many cases in Pennsylvania, it's been enormously labor intensive and challenging to address the myriad of issues that it presents.

We've established a state-wide taskforce that includes our public health and emergency response partners. We've partly activated our emergency operation center. And we've set up an internal health department taskforce. We've reached out to the education and agriculture sectors, migrant centers, medical societies, the rich array of academic centers in our state, the pharmaceutical sector, and the state's major vaccine manufacturer.

And most importantly, we've closely integrated our work with that of our network of district and local health departments who form our frontline eyes and ears through daily group phone calls to discuss cases and disease clusters. We've greatly relied upon the excellent work done by the CDC, including their guidelines, lab support, the pharmaceutical stockpile, and their technical backup.

We and the states have had an ongoing dialogue with CDC about all aspects of this event. And sometimes we've disagreed, like in the school closure area. But CDC has been very willing to listen and change course when appropriate.

Some aspects of our response have gone quite well. These include risk communications, disease monitoring and investigation, and applying control measures to limit disease spread. Other areas have been more challenging, especially the lab support where backlogs quickly developed when specimens had to go to CDC.

We in Pennsylvania continue to individually count, investigate, and respond to each identified case of illness due to this new virus. With less than 300 cases even this has been very resource intensive and has strained our disease investigators and our laboratory.

Like most states, we've been impacted by the economic situation. We have hiring freezes in place. And our bank's spend strength is not very deep at all.

Because in general we don't count individual cases of seasonal influenza many of the most heavily impacted states are now no longer doing it for this new flu strain either. Instead, they only count severe cases, and those in special circumstances like health care workers and pregnant women. This makes the national numbers that you're hearing now being reported very tough to interpret since states are counting cases differently.

In Pennsylvania because many parts of the state have still been minimally affected by this virus, we think it's important to understand where the virus is, how it is spreading, and who it's affecting. So we will continue to count until it's no longer feasible for us to do so.

So far many aspects of our preparedness efforts have not been engaged. As examples, we've not dipped into our pharmaceutical stockpile. We've not mass distributed vaccines or antivirals.

We've not handled large numbers of sick or dying people. And we've not implemented full community mitigation efforts. And hopefully we won't have to do so. But it is important to be prepared in case we need to. And so we in Pennsylvania have just initiated a process to review our efforts today and see what has gone well, and where we need to improve.

We're also embarking on a planning effort to prepare for what the virus has in store for us in the coming months. This includes doing better monitoring, planning for distribution and administration of stockpile material and vaccines, and dealing with health care surge needs.

The flu is just one of a long line of emerging infectious disease threats. Others include SARS, MRSA, West Nile, food-borne outbreaks, vaccine preventable diseases. All of these highlight the need for a robust and a well-trained public health workforce, and for flexible resources that we can best apply the resources that we have where they are needed.

At the state and local level the same people address all these problems in the field and in the lab. While our preparedness resources have helped, they do not cover nearly all of our needs. And our resources for emerging infections have dwindled in recent years.

Despite these problems, all of us are firmly committed to continue to address this new flu virus while continuing to confront the other public health threats that we face. I'll be happy to answer any questions.

SEN. PRYOR: Thank you.

Let me start with you, Ms. Steinhardt, if I can. In your GAO report you have several criticisms of the state of affairs right now. One of those is about the roles are not very clear, sometimes between state, federal, local on who makes the decision on certain things. What would you recommend that state and local officials do to clarify their roles?

MS. STEINHARDT: Well, the important thing -- and this is the lesson that we learned, I think, most vividly, from Katrina. The important thing is to test and exercise.

It's often been said that you don't make friends in the middle of a disaster. People need to know each other, and figure out how they're going to work together in advance of a true emergency. And that's what needs to happen here as well.

SEN. PRYOR: Okay.

And I notice the GAO, the NGA, and the ASTHO have reports, this is basic, they all pretty much say that you need more guidance in school closures, that you mentioned, and several areas like private sector workforce, situation awareness, et cetera.

Do you think the federal government could distribute policies on these issues by this fall, or is it too late for this year?

MS. STEINHARDT: I would hope that the federal government could do that. I think there is a lot -- as my fellow panelists have said, there is a lot that we're still learning about this virus. But certainly there is more. Some of those lessons learned can and should be shared with states and local governments as well.

SEN. PRYOR: Mr. Thomasian, in your experience in terms of defining roles and, you know, some of the gaps that Ms. Steinhardt has identified, how has the federal government been to work with?

MR. THOMASIAN: In the past administration, I would say the lead agency was clearly HHS. They -- Secretary Leavitt took it on himself that under his watch he was going to try to avoid not having these roles defined. So I think we got one strong but one siloed (ph) lens looking at that.

SEN. PRYOR: So -- I'm sorry, he wanted to not define the role?

MR. THOMASIAN: He -- no, he did want to define the roles. But as -- since he represented a single agency he only -- he had certain boundaries.

SEN. PRYOR: I see.

MR. THOMASIAN: And so I think we got halfway there. I think we still have ways to go. It was -- I was pleased to see that the Department of Homeland Security worked well together with HSS during this initial crisis. Again, we have not been fully tested, so all the roles have not been fully defined or explored. The tensions have not been exposed to a large degree. But it was an initial good first step.

So I do believe they've tried to do a good job. And I will reiterate my panelist's assertion that the best way to define a role is to initially put some aspects down on paper, but you have to exercise, you have to test it. Relationships need to be built.

SEN. PRYOR: Okay. Let me follow up on that, if I may. And that is that when the National Response Framework and the National Pandemic Implementation Plan were being put together there was lot of criticism that the federal government did not work with and talk to the state and local governments effectively. Not -- you know, either not at all, or infrequently, or something.

But now they've been working on the first responder health surge capacity action directive. Have they been working with the states and with the local folks as they're putting that together?

MR. THOMASIAN: They are. We worked very closely, I should say, with the Governors Homeland Security Advisors. In fact we have formed an association within our association called the Governors Homeland Security Advisors Council. And it's our understanding they are working together with them.

Again though, it does take a while for all this to trickle down through the states. This has been a constant refrain from the Governors Homeland Security community that the federal government needs to full advice and work through issues with the states.

I believe we're on the right path. It's too early to tell that it is all -- that it has taken place in all cases though.

SEN. PRYOR: Dr. Jarris, did you have any comments on that?

DR. JARRIS: I think we -- it's worth questioning the model. The model that the federal government will sequester itself and develop guidance for the nation is a model that doesn't work well.

There is a certain amount of expertise whether it's scientific or law enforcement in the federal government. But actually the people who implement this guidance are at the state and local levels. And what we fail to appreciate is the expertise in implementation. So a model that will work much better is if federal, state, and local, all work jointly on guidance.

Right now what we do is we play ping pong. The federal government comes out with something, lobs it over the table; we say it doesn't work, we lob it back. We don't have time for that in 14 to 16 weeks. What worked well in this response to date is that we really were working together. Information flowing up and down modifying what each other was doing.

Now, we seem once again to be flipping back into the old model of the federal government will come up with guidance for the fall. It simply won't work.

For example, school closure. That is primarily a public and political decision, to close schools. It is not fundamentally a science-based decision. So what we need to do is to work with the mayors, the governors, and those who make the school closures, and the health officials who will make recommendations to them, to truly understand all the issues there so we can do, if you will, a cost benefit analysis.

There is no way that the federal government guidance can come out without true involvement of the local and state officials making these decisions and have it work.

SEN. PRYOR: So are you recommending that we get some sort of summit together, or some sort of --

DR. JARRIS: Well, a summit would be helpful. But an ongoing working relationship would be far more helpful.

SEN. PRYOR: And does that not exist right now?

DR. JARRIS: The tendency is for federal government to develop guidance. There may be input sought. But then it goes back into the sequestered environment and the guidance comes out. And I think it's much more efficient actually if we could sit down as federal, state, and local, and jointly work on guidance.

SEN. PRYOR: Okay.

This is little bit of a follow up to something I think you said in your opening statement as well. And that is there are a lot of assumptions about the flu. And the H1N1 did not really follow those assumptions.

DR. JARRIS: Yeah.

SEN. PRYOR: It didn't start in Asia. It didn't, you know, go from a bird population to human population, all that jazz. What do you recommend -- or how do you recommend that we build in flexibility to all this planning so that if, you know, a different scenario presents itself like H1N1 has so far -- it didn't really follow the textbook example -- how do you build in flexibility?

DR. JARRIS: Yeah. You know, I think with a novel virus, it's a mistake to assume there is a textbook -- (laughs.) They all operate differently. So really what we need is have much more robust planning. It's not just a matter of scientifically planning for -- we need to have modelers in there, we need to have systems engineers come in and figure out what's going to happen.

So, for example, we should plan for a best case, a worst case, and a most likely case scenario, and hope that that covers the basis. Of course, something out of the blue will happen. But, for example, if we look at the vaccination campaign for the fall, we will have an initial bolus of vaccine coming out probably sometime around October, but we don't know how fast it's going to grow.

That vaccine will come out with initial bolus; we don't know how much that will be. It will then come out with weekly numbers -- so certain amount for a week; we don't know how much that will be. That will be distributed on a per capita basis in the country. And we have to get on a priority list -- which incidentally the priority list we have is for H5N1 not H1N1.

So you see how many unknowns there are here. What will the adjuvant do? We haven't gone through the safety studies yet. We actually don't know if it's one dose or two doses.

So there are so many complexities here, and we will not know ahead of time enough information to make the decision. So at the outset, we have to come up with operational assumptions and plan around those assumptions with different scenarios.

SEN. PRYOR: And you had mentioned the costs of providing a vaccine to every American. And what's your overall estimated cost on that?

DR. JARRIS: Well, if we assume -- we don't quite know what, again, the vaccine is going to cost, it hasn't been developed yet. We don't know the cost of the adjuvants that may be in it. So probably between ($)5 and $10 a dose -- $10 is what normally costs for a regular seasonal flu. And we assume 600 million doses.

So we're talking somewhere in the $6-billion range. It could be more, it could be less. But then we actually have to give the vaccine. And we estimated that there is a number of ways. We had dozens of states and local health departments who did a cost basis for them to give a vaccine. Medicare pays ($)18 to $20, Medicare pays costs.

We checked with Visiting Nurse Associations, we checked with private sector. So the ranges are anywhere from about $12 to $30. We picked ($)15 which I think is a reasonable dose. So ($)15 times 600 million, we're talking about another $9 billion.

SEN. PRYOR: And how does that square with your thoughts on planning, though, because at some point you got to pull the trigger on the vaccine about whether you're going to go with this particular vaccine or not, and you know, if the strain changes like down in the Southern Hemisphere or whatever, is a different strain this fall or whatever the case may be. So when is that point where you have to pull that trigger?

DR. JARRIS: There are seedstock developed now. It is my understanding -- and I'm not Dr. Fouchi (ph) -- (laughs) -- but it is my understanding that variation has not been tremendous around the world yet. So we think we'll have a vaccine that will probably cover all the options, unless there's some major mutation. So that seedstock will then have to go into production.

At the same time, we need two to three months to do the scientific testing for safety, for response, for dosage, and things like that. So we will have to make the decision soon and early to purchase -- we've already put a purchase order in this country -- not only because we need the lead time to develop the vaccine, but because other countries are already in line -- Great Britain, France, things like that.

So you know, to put our place in line, we're going to make a purchase decision very soon. Now, it's one decision to purchase -- that we'll have to do early -- it's another decision to give it. We're going to have to look at in the fall based on the safety studies to say okay, given what we know, we have this vaccine, should we actually give it to people.

And I think we have to carefully consider that, because all vaccine has side effects, and we'll have to weigh the severity of the illness in the fall versus potential side effects of the vaccine. So that's a later decision, I would guess, that's going to be made probably in August-September timeframe.

SEN. PRYOR: Mr. Thomasian, let me ask you kind of a follow-up to what Dr. Jarris was talking about. And that is, you know, we've talked about a lot of different scenarios that it could take, administering a vaccine, and how to distribute it around the country, around the various states. From your standpoint, how should that be done? Should you let the various states make that decision on how it's distributed, or should there be one national policy that the states just follow or -- tell me your --

MR. THOMASIAN: Well, the way it's currently laid out is the states' plans have appeared, plans on how they would distribute vaccines and antivirals and they have priority lists that match up, to a good extent, to the federal senses of priority. So I don't think there's a huge variation out there. So I would say let the states administer it with a joint discussion between the federal government and the states on what type of priorities.

I'm saying that because I'm assuming, and I think it's safe to assume, that we would not have vaccines for everybody. So we would have to be focusing on the essential service individuals in the most vulnerable populations. Otherwise, I think we can probably go to the open market distribution of vaccines.

SEN. PRYOR: Dr. Ostroff, do you have any thoughts on that?

DR. OSTROFF: A specific about the vaccine, you know, there is obviously a lot of unknowns, I think, as Dr. Jarris pointed out. In terms of --

SEN. PRYOR: Let me just interrupt there. I mean it seems to me that you can do a lot of planning and you can be prepared in some ways, but because the vaccine needs so much lead time, that's sort of a separate question that, you know, just makes it hard to figure out, you know, what the best way to go is, but --

DR. OSTROFF: Well, I think -- you know, a couple of other points just to consider. One of them is, I think as Dr. Jarris rightly pointed out, we shouldn't look at the current situation as being in the past tense. We in Pennsylvania, our numbers have gone up by a third in just -- since I put my testimony together this weekend. So it's quite active right now in Pennsylvania.

It shows no signs of abating. I think that we all anticipated that it would dampen down over the summer months -- the virus may not have read the textbook, and may decide not to do that. The other thing that we have to remember is that in 1918, which is the model that we've all been looking at, virus came back very early. It came back in September, and it came back with a vengeance in September. It didn't wait until the usual winter influenza season.

And so in terms of our thinking about what to do related to vaccine, I think that we have to really put our decision-making on the fast track about what to do, because by the time we make decisions over the next couple of months, the virus may have jumped out ahead of us, and it could come back in a form that's more severe than it currently is.

The other, I think, issue to also keep in mind is that we're relying quite heavily on antiviral drugs, the antiviral drug of choice -- if you look at the seasonal strain that was just floating around the country that was resistant to that particular drug.

And so, you know, if this particular virus decides to get together with that one and transfer its resistance between them, then that's sort of out of the assumptions and planning. And so I think, you know, as far as the vaccine -- I'm not sure that we have a lot of time to be able to make these decisions.

I think the virus is telling us, because right now -- virtually all influenza right now in the U.S. -- and again, it's a very unusual time to be seeing this disease -- is this virus. And so it may not be an option, you know, the regular one versus this one. I think that we have to look seriously at what the virus is telling us right now and make our decisions relatively quickly.

SEN. PRYOR: Okay. Given all the circumstances that we're in right now, and also given the fact that in the supplemental appropriation that's working its way through the Congress -- and hopefully will get to the president's desk in the next couple of weeks -- we put $1 billion in there for pandemic flu issues and you know, preparedness. Do you have an idea on how that money should be prioritized, what the most critical needs are to get us ready for this?

DR. OSTROFF: Well, there are a lot of needs -- (laughs) -- and I think many of them have been pointed out. Again, we have not been fully exercising the full gamut of things that we would need to do for a full-fledged pandemic. And I think that we do need to very quickly come up with our plans as to how we would distribute the vaccine.

I think when the vaccine becomes available there's not going to be enough for everybody, and we're going to have to make decisions about how to prioritize who gets it and who doesn't. And we generally do that based on what we see about the patterns of disease. I think that we have to work out much better than we did how to distribute antiviral medications.

And in addition to that, I do think that we have to very quickly figure out what we're going to do about the medical surge issues, because again, most of us haven't had to exercise that part of our pandemic plan. And the last thing that I will say is that for us if there is a lot of disease both being able to monitor what's going on as well as do the diagnostic work in our laboratory -- I mean Pennsylvania is a large state, we're the sixth largest state in terms of population.

We only have 300 cases, and it's been all we could do to be able to count what we're seeing and to make the diagnoses in our laboratory. And we're sort of relying on two people in our laboratory to do all this work, and if one of them gets the flu, then we're down by 50 percent. And so we need to, I think, pretty quickly figure out how we deepen our bench strength between now and the fall, because I think that these will all be serious gaps for us.

The last thing that I will say is that in terms of the federal guidance, one of the things I think that's important -- and I have a fairly unique perspective, because I worked at the CDC for 20-some years, so I was on the giving end rather than the receiving end for all that time period -- is that we don't like it to be so proscriptive that there is not a lot of wiggle room.

We in Pennsylvania, as far as school closures, we set up our policy right from the very beginning. We've held to that policy all along. We didn't think that the initial recommendations from the CDC were quite correct. And we didn't think the revised recommendations were quite correct either.

So we don't want them to be so proscriptive that it looks like we're not following what other people are doing. Each state has to take that guidance and interpret it and translate it to their local circumstances. That's what's being done in Arkansas, and that's what we're doing in Pennsylvania.

SEN. PRYOR: Let me ask, if I can, on this medical surge question that you brought up, and it's just really for the panel at large. Given the economic downturn and given in certain hospitals, first responders, you know, you name it, there has been some layoffs and just some cutbacks.

Lot of cities and counties and states are having to do cutbacks, and this can be very painful. But it seems to me this is the worst time that they could be cutting back on these type health-related services, but the reality is what it is. So any advice for this fall, Dr. Jarris?

DR. JARRIS: Yeah, it's an excellent question, Senator. We have looked at state and local public health agencies, and due to the budget constraints in the states we've lost over 11,000 positions in the last year, and that phase is continuing. So we -- and given an outbreak -- and we've already seen this in the last several weeks -- we've taken a drastically diminished workforce and put them on two shifts from one shift.

There is only so much people can do, and that really strain the system. On top of that, of course, we've had certain states who've actually run out of places to build the pandemic response, so they're actually ramping down in the face of an escalating outbreak. So this is again the reason why we need some federal assistance to round (ph) the response and protect the American people.

SEN. PRYOR: Mr. Thomasian, do you have any thoughts on that --

MR. THOMASIAN: Well, it is an excellent point. I will say that in our work at NGA, we projected even after the recovery dollars are spent, that states will be facing over the next two years somewhere between ($)170 and ($)230 billion in deficits across the states. So it is a tough time -- it's very difficult to build a government around a peak event that may not occur.

I do feel, though, that if further resources were available to states, there are some critical areas. It would certainly help; it may not address all the surge capacity, but certainly one is laboratory capacity is sorely needed in the states, also assistance again on exercising. Clearly, states will need to build as much capacity as they can afford to do in these areas.

But honestly, I think this is an area that was not been tested in, and we'll probably find that we will be sorely behind when -- if that large event does come.

SEN. PRYOR: Yeah, yes.

MS. STEINHARDT: Just to add to the comments that have already been made, looking at vaccine production at best, at least from my understanding, if we begin today, we are looking at November for the initial production line for this virus. So we still have this long period between now and then in which communities have to be able to respond to the continuing epidemic or a resurgence in a more virulent form.

And so the kind of planning, the kinds of activities that have to take place before we even have a vaccine are really our first -- need to be our first considerations here -- what kinds of capacities do we need to build into communities. And I think as we look at priorities for funding and allocations of funding, we need to keep that very much in mind.

SEN. PRYOR: Okay.

As I understand it, the World Health Organization is deliberating whether to move this from a phase V to a phase VI. First, I don't understand the complete significance of that. And second, I guess, Dr. Ostroff, if they move from a V to a VI, what does that mean for the U.S.? I mean how does that change things here?

DR. OSTROFF: I think in practical terms it really doesn't change very much for us. Our planning, our thinking, our activities are all predicated on what we think the appropriate things to do in the United States are. I do think that part of the difficulty and why WHO has been having such troubles around this particular issue is that when you move to phase VI, it sort of trips off a whole lot of activities in other parts of the world, some of them appropriate and some of them inappropriate based on their particular circumstances.

And so I think it does make a difference. I think that we've seen many countries do things that, you know, in terms of entry and exit screening, et cetera, that may not necessarily be the best application of resources. And if this would give them further reason to do some of those things, then I think it would be somewhat problematic.

But in terms of the way that we would approach what needs to be done here in the United States, I don't really think it makes that much of a difference which level they define it as.

SEN. PRYOR: Dr. Jarris?

DR. JARRIS: Yeah, I would agree with my colleague that in terms of our response in the United States within our borders, it probably doesn't change what we do, because we have the epidemic. But as a global leader, it may very well change what we do. One is as this continues to spread around the world -- which it has been, and frankly it's almost academic whether they declare it VI or not, because I think they met the criteria a month or more ago, but there's been political discussions.

But the issue is what will the United States play in terms of a health diplomacy role worldwide. If we have outbreaks hitting poor, lower, undeveloped countries or developing countries who do not have an infrastructure for public health, and we see many more deaths because some of these countries have high rates of HIV, what will the United States do?

Will we feel responsibility to go and assist these nations, and what is our responsibility to the rest of the world with regard to things like vaccine and antivirals? If we were producing antivirals with our domestic capacity only for the United States, we might produce it one way -- without the vaccines bearing adjuvants. However, the whole world needs the vaccine.

And if we need to help other parts of the world, we probably do have to put adjuvants to stretch the supply that we can produce even further. So I would suggest that our political leadership involved and scientific community involved with global health issues, have some significant questions to address in terms of U.S. leadership.

SEN. PRYOR: That's fair enough. Let me ask about this map that we have here. You can see the confirmed cases around the world.

When you see a map like this and when you look at the numbers, the quantity of this around the world and the fact that it's spread out geographically, from a scientific perspective does that increase the chance of mutation, or does that have any bearing on the chances of mutation?

DR. JARRIS: Every infection increases the chance. Viruses do mutate rapidly, and as they travel around the world and are exposed to different populations of humans, of animals, there is an increased chance of reassortment. So yes, the more it spreads, the more the chance of reassortment. Now, one thing to consider is since this is a novel virus, there isn't a heavy evolutionary pressure on it to evolve.

In and of itself, it is making people sick and surviving. So we can't conclusively say whether it will reassort or not. The great fear, of course, is that it -- you know, it does mix with someone with H5N1 or mix with the seasonal influenza that is Tamiflu-resistant, and then we're in trouble. But that really is another one of the unknowables.

SEN. PRYOR: Mr. Thomasian, let me ask you about the Medical Reserve Corps. Can the states activate that, and what's that process?

MR. THOMASIAN: I'm not completely familiar with the activation process. I believe they can, but I would have to get back to you on that.

SEN. PRYOR: Dr. Jarris, would you --

DR. JARRIS: Yes, there is a Medical Reserve Corps that has been very helpful in certain limited disasters around the country. What we found in areas severely hit, the Texases and Louisianas during their hurricane, though, is the Medical Reserve Corps are people who have other jobs. And so when you are mounting a sustained response, they can't be counted on to be there day in and day out in shifts.

So the doctors have to go back to their office to practice, and nurses have to go back to the hospital or the health departments to do their shift. So what Texas has found, in fact, is that although they welcome them and like to work with them, they've actually had to go out contract and for paid professionals to come in and work for them, because then you have performance standards that you can maintain.

That again will be important with the vaccinations in the fall as well as if we have to do mass dispensing of Tamiflu. We're going to have to hire in contract nurses or hospital nurses or VNAA nurses which means with them having other jobs, time-and-a-half, weekend pay, and things like that.

SEN. PRYOR: Okay. Let me ask this. I'm getting down to the end of my questions. And like I said, we'll keep the record open and some other senators will probably have other questions. But given the last few months where the flu was first discovered in North America -- and it was almost wall-to-wall coverage there for several days on the cable news channels, et cetera.

How did the media do, and how did the public health officials and the elected officials do in, you know, getting the word out to the public and communicating the nature of this? Can you all grade that? Is that one of the lessons learned that we can do?

MR. THOMASIAN: One of the comments I addressed. I think I would give them high marks. I would give the federal officials and the public officials at the state, local level high marks for communicating to the public and communicating to the media. And the media did a good job, I think, reporting on the nature of the disease and where it was.

Again I think where the breakdown began in some areas was, well, so what do we do, what is the appropriate government response. And I think there was some initial hesitancy at the opening to talk about issues like quarantine and why you should and why you shouldn't use it and issues like travel bags so that we got into this situation for a while where there was a discussion of should we block the borders in Mexico that percolated for a few days.

But initially, I do think that the communication was very good. And I think the public had a sense of this disease was existing out there, it wasn't a disaster, and they were getting up-to-date information.

SEN. PRYOR: Did anybody else want to add to that?

DR. JARRIS: There was a study done by Harvard University, a sample of the American people -- and I mentioned briefly before -- 88 percent of Americans that were surveyed expressed satisfaction with the information they were getting. So I think we did a good job. I think the -- it was clear. And Dr. Besser should be commended; he did a wonderful job for the acting director of the CDC.

The one place I think we're falling down right now is we've shut it down. I mean you can't find anything in the media anymore. We should be using this time to let people know that now is the time to prepare. Now they should figure out in the fall if their kid's school is cancelled how are they going to take care of the kids, how are they going to telecommute, what if their elderly parent gets sick. We are missing an opportunity now ahead of time to have people think about the fall.

MS. STEINHARDT: If I can add to that?

SEN. PRYOR: Yeah, go ahead.

MS. STEINHARDT: I think I would agree that the response and the communications were first rate. But I think from our experience looking at what happened several years ago when we first began to see cases of bird flu and outbreaks of H5N1 virus in humans, there was an enormous amount of attention, and then it fell off. And for most of the public, it seemed as though this issue went away completely.

And unfortunately, what the public loses interest in, government often loses interest in as well. And that I think within the public health community, members of the public health community never lost sight of this problem. But otherwise, we let other issues take priority. And I know -- we know this from just conversations we had with people in the private sector -- other food safety issues, whatever the issue of the day was, that's what took attention.

And so we need to, I think, somehow keep sight within government of our priorities and what the real dangers to the public are, whether it's covered in the media or not.

SEN. PRYOR: And Dr. Ostroff?

DR. OSTROFF: Yeah, I'll just add a couple of comments, because I agree with everything that was said. And you know, I think that over the last few years it's been ingrained in the public's mind that when something happens related to flu it's going to be like the big bang. And when that didn't quite happen right at the very beginning, I think there was a tendency for everyone to shrug their shoulders saying what's the big deal here.

And what you heard was a lot of descriptions of this as being mild. Flu is never mild. And we tried very vigorously to say that this is not a mild disease now, and it could be even more severe in the coming months. And so I do think that there is a segment of the population who feels that this was sort of, like, oversold to them when in point of fact I think that many of us are very concerned about what we're seeing right now, and we're awfully concerned about what's going to happen in the fall.

And so I do think that I would echo the comment that we have to continue to reinforce the message that what you've seen so far might not necessarily be what you see later on. But having said that, I would fully concur, I think, that federal officials in particular did a fantastic job conveying information to the public.

It was a transitional group of people. And given the circumstances and the amount of attention that this initially got, I think they did a wonderful job.

SEN. PRYOR: Let me follow up on that if I may, and maybe Ms. Steinhardt, you may be the best one to ask. And that is there is a sort of a low period right now in terms of public awareness on this. If it comes back this fall, the low will be over. All of you will be looking back and saying why didn't we do something different.

What would you recommend right now to the private sector in terms of the things they can be doing? It sounds like, you know, the government is going to continue to plan and work and try to coordinate, and there is a lot of work that we've talked about that needs to be done. But we haven't talked a lot about the private sector yet. Do you have any suggestions for the private sector?

MS. STEINHARDT: Well, I have suggestions for the government in working with the private sector. We have this system of coordinating counsels that for our critical infrastructure sectors, and in fact, in work that we did here, we found that they could be used much more than they currently are.

There are a lot of questions that the private sector has about within these critical sectors that they have about how government policies are going to work, how are states and federal government going to handle state border closings. These are vital issues for commerce. And those discussions should be happening today between private sector and government.

They're not -- we're not in this alone, and these are issues that have to be resolved in tandem. And that's one area where we certainly would urge greater attention.

SEN. PRYOR: I have one last follow-up question -- it's sort of a two-part question I want to ask each of you this. And that is, what is the single most important step that we can take to increase our preparedness in the next three months, you know, from now to the fall -- next three months? What's the single most important step we can take, and how do you suggest that we do it?

Dr. Ostroff?

DR. OSTROFF: Well, I wish I could tell you that there was a single step -- (laughs) -- because there isn't. There is a series of steps that, I think, we need to deal with.

SEN. PRYOR: Sir, one thing, though --

DR. OSTROFF: Well, I think that the two areas that I really think that we need to focus on is we need to get our house in order for issues related to vaccination, because we know for influenza that that is the single best preventive measure that we have available. And I do have concerns that we will see more morbidity and certainly more mortality for this as we go along. And I do think we have to think about how we deal with medical surge issues.

SEN. PRYOR: And so you are thinking vaccine, even though it could mutate, but you're saying place your bet on what you know about --

DR. OSTROFF: I think not placing your bet on what we currently know would be a significant mistake.

SEN. PRYOR: Okay.

Dr. Jarris?

DR. JARRIS: Limited to one it's a very difficult question, because there is so much that has to be done. But I would think that if I was in the shoes of Congress and the administration, the single most important thing to do is to appropriate sufficient resources in the next two weeks with a supplemental. There is so much that needs to be done, we don't have time to catch up later. And earlier, you asked how to prioritize the ($)1 billion. And that is a very difficult question, because that's -- the vaccines are ($)15 billion so --

SEN. PRYOR: That sounds like a lot of money, but it's not --

DR. JARRIS: Yeah, in the old days -- (laughs) -- but frankly, if we appropriate less than what is needed, for example, the ($)15 billion for vaccines and that's -- we need more than that, then the question in that sense would be well -- if we appropriate ($)1 billion, which 1/15th of the American public are willing to vaccine, and which 14/15ths are we not willing to vaccinate.

SEN. PRYOR: Doctor -- I mean Mr. Thomasian?

MR. THOMASIAN: Thank you. Well, it's excellent question, you know. And I will take mine beyond the public health arena. The one thing that we need to keep in mind is that we -- this was not really a test; this was not really even a pop quiz. When we did our workshops, we asked states to envision a scenario where 90 million people came down with the disease.

And we had 101.5 million people needing intensive hospital care and an estimated 1.9 million deaths. And I would have the states when -- if they received resources for exercises and further planning, to consider how they would maintain continuity of society under those situations. Well, how would public safety react, how would we handle the high degree of absenteeism in both state government as well as our critical services such as food services, electricity, et cetera.

So I would use these intervening months to examine what would happen if this became the true pandemic in the scenarios that we thought we would be looking at under the 1918 scenario, and go beyond the public health aspects and look at the public safety as well.

SEN. PRYOR: Okay.

Ms. Steinhardt?

MS. STEINHARDT: Well, I would certainly support that. I would say this is our time now to take a look at what our plans are, what our plans have been, what we've learned from what's happened over this last month, what assumptions do we need to revisit. This is our opportunity to learn from a real life test, and it's also our opportunity to actually pull in the results of a number of different tests that have happened over the last few years.

I don't think we've learned nearly as much or incorporated the lessons learned from the various tests and exercises that have been done around the country and incorporated that into our thinking. But now we have this opportunity to just take that cause and think about what we know and what we need to change in our plans going forward.

SEN. PRYOR: Listen, I want to thank all four panelists, and hope I didn't grill you too much. But we are going to leave the record open as I mentioned, and I know Senator Ensign and others will submit some questions for the record. We'd appreciate you getting those back to us within 14 days.

And thank you very much for your attention to this, and I appreciate all the work you've done in your various capacities and to -- you're playing a very, very important role in saving American lives, and we just appreciate everything you're doing. So with that we're going to conclude the hearing and just leave the record open for 14 days. Thank you. (Sounds gavel.)

END.


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