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REMARKS BY:

Michael O. Leavitt, Secretary of Health and Human Services, Admiral John Agwunobi, Assistant Secretary for Health, and Dr. William Steiger, OGHA Director and Special Assistant to the Secretary for International Affairs

PLACE:

Palais des Nations
Geneva, Switzerland

DATE:

May 22, 2006

Transcript as Delivered: Press Availability with Michael O. Leavitt, Secretary of Health and Human Services, Admiral John Agwunobi, Assistant Secretary for Health, and Dr. William Steiger, OGHA Director and Special Assistant to the Secretary for International Affairs on U.S. Participation in the World Health Assembly

Secretary Leavitt: Good morning. Thank you for the opportunity to address you. This is an impressive gathering at the World Health Assembly and one that I've looked forward to.

First of all, I'd like to comment on my good friend, Dr. Lee Jong-Wook, and his passing. In the fall of last year, I traveled to Southeast Asia to six countries with Dr. Lee. It was a time of great learning for me. I not only learned a great deal about pandemic influenza, but I was a student of Dr. Lee's in understanding the importance of global cooperation. He embodied, in my judgment, the spirit of cooperation and has done a great deal throughout the course of his career to foster it.

During the course of our travels, Dr. Lee shared with me how he was, as a young boy from the war-torn country of Korea. He spoke with me of three difficult, arduous months where he and his mother walked mile after mile after mile in search of his father who was, during that cold winter, in exile. Dr. Lee experienced hardship at a very early age, and my sense is it was the reason that he devoted himself to public service.

He offered the WHO visionary leadership and a cooperative spirit. He strengthened the WHO and its role in the global health community. My thoughts and prayers are with his family.

There are, of course, many important issues that will be addressed here at the assembly. Infectious diseases, including HIV/AIDS and malaria, continue to cause worldwide suffering and demand our continued commitment of resources. Conquering disease will require an exchange of information; it requires research across the world, and it requires a strong system of intellectual property and incentives to promote private sector investment. The private sector needs to have incentives to create and innovate, and intellectual property rights are essential to creating those incentives. We will continue to advocate that position.

But today I'd like to focus most of my attention on the threat of human influenza and a potential of a pandemic. We in the United States are doing what is necessary to prepare. We want to be of assistance to the world community as we work together. The President has mobilized our Nation. At his direction, I have been traveling to each of our 50 states to host a pandemic summit with local leaders from both government, from business, from education, from health care. Over the last 150 days we have completed nearly all of those summits now. State and local communities are developing preparedness plans and we're now in the process of exercising them.

At the national level, we've been making significant investments in vaccines, antivirals, and research. The research is likely to benefit not only the citizens of the United States, but also citizens of the world.

Just recently I awarded a $1 billion contract or series of contracts to develop cell-based vaccines against both seasonal and pandemic influenza. This will help modernize and strengthen influenza vaccine production by creating an alternative to producing influenza vaccines in eggs.

At the Centers for Disease Control and at the National Institutes of Health, we're developing new vaccines for the H5N1 virus. Our goal is to develop a library of live vaccine candidates against all known influenza strains with pandemic potential. This should allow a faster head start as any strain emerges.

We're also working on adjuvants or dose-sparing measures that could enable the U.S. to produce more treatment courses faster for more people, and we're developing rapid diagnostic testing for H5 strains that shorten the testing time from what has been in the past two or three days to just a matter of four hours. I will tell you, in my judgment, that's still too slow and we continue to work hard in that area to make substantial investments in rapid diagnostics.

We're also looking at mitigation strategies should a pandemic break out. Some recent pandemic modeling that we've been involved in suggests that there are partially effective interventions such as school closings and social distancing and the like, and we're working to use them in a layered manner that can be highly effective, we believe, in controlling influenza in a community. We intend to take that information, to share it and peer review it, and begin to spread it for not just within the United States, but throughout the world. We think it's an important potential contribution.

But responding to a pandemic will require the cooperation of the entire world. No nation can go it alone. If we are to protect the people of our nation, we need to work together to protect the people of the world. We think there are four principles of preparedness. We've spoken of them before: transparency, rapid reporting, sharing of data, and scientific cooperation. The United States will do its part to advance those principles. We're funding a Specimen Transport Fund that is being managed by the WHO Secretariat. It's a key innovation in getting samples from affected countries in a timely and secure way. I'll be urging other countries to join us in development of that fund. We're also supporting early voluntary compliance with the revised international health regulations. We've made sizeable investments in creating a worldwide network of surveillance most recently with international labs, Institut Pasteur, Gogas, and also ICCDRB in Bangladesh.

President Bush has made clear his commitment to a forward-leaning position on the development of antiviral stockpiles. Today, I'm pleased to announce that the United States government has just deployed treatment courses of Tamiflu to a secure location in Asia. The shipment is currently in transit and it will arrive later this week.

The United States has pledged $334 million to help nations prepare for, and respond to, outbreaks of avian influenza, but now the challenge must turn from pledges into preparedness. We need to turn dollars and currencies from all nations to make a real difference, but we have to coordinate them. I'll be working through the course of this meeting with my colleagues from throughout the world to coordinate expenditures on a global effort.

Later today, I'll be meeting formally with my fellow health ministers from the G-8. This will be a follow-up to meetings we had in Moscow. I'll be discussing with them a more detailed effort through our International Partnership on Avian and Pandemic Influenza. A meeting will be held in Vienna in June, and I want to use this meeting as a means to advance our discussion toward a coordinated plan so that the $1.9 billion that was pledged at the Beijing Pledging Conference can be used in an efficient and thoughtful way.

In closing let me just say that my primary purpose at this meeting, along with the many issues I alluded to earlier, is to focus on the principles of transparency, rapid reporting, sharing of data, and scientific cooperation. It's my belief that we are better prepared today than we were a year ago when I attended this conference. The goal at this conference is to assure that we are better prepared a year from now.

I'd be happy to respond to any questions.

Question: Mr. Secretary, where do we stand really on the threat of mutation? It seems that after four years of this bird flu epidemic or pandemic all over the world, that mutation still hasn't occurred and there is a tendency for people to let their guard down. Do you think that's premature? Is the danger still as big as ever, or what?

Secretary Leavitt: Pandemics happen. They have happened for centuries. There is no reason to believe the 21st century will be any different from any of the previous centuries. We have had ten pandemics in the last 300 years. We have had three pandemics in 100 years. The concern we have of course is that the H5N1 virus and its various strains, various claves that are emerging, have genetic and clinical similarities to the virus of 1918. I believe that we are at greater risk of a pandemic than we have been in decades, and that we must prepare. We are overdue and unprepared and what occurs at this meeting will be an important step in assuring that the world community is working together to prepare. We are all in this one together. There is no question that if it exists anywhere, there is danger everywhere.

Question: To what extent are the plans that you're developing likely to be relevant to mega-cities like Nairobi, or Mexico City, or places where there are large slums?

Secretary Leavitt: Part of my visit in Southeast Asia with Dr. Lee, and Dr. Chan, and others involved visiting large cities. It became clear to me at that point that the challenges there are unique.

I mentioned earlier that we are involved in substantial modeling, trying to determine how best to stop the spread through social distancing techniques. We think that under any circumstance we will likely be in a period of nearly six months without a vaccine. It takes that long to develop a vaccine from the virus. Therefore, good preparation will include the use of social distancing techniques and that will be particularly important in large cities. I do not, however, understate the unique challenge in large complex cities such as those you have mentioned.

Question: You mentioned $350 million --

Secretary Leavitt: $334 million.

Question: What is your plan for Latin America, since it's your region, and where actually many countries did not buy any (inaudible). If you have any specific plan for Latin America.

Secondly, on the Kenyan and Brazilian proposal during the WHA on neglected diseases, what exactly is your position on that and why is it a problem to create a commission to guide investments to these developments?

Secretary Leavitt: I will be releasing a little later today the breakout of our $334 million as to how we intend to deploy ours. That's done in the context of my encouragement, with other members of the community, to begin putting their pledges out in categories so we can begin to coordinate it. It's my hope; I'll be meeting later today with members of the G-8 to encourage them to do the same thing.

With respect to Latin America, may I just say that I am going to be going to Panama in early June to meet with many of the health ministers from Central America, in particular, to do what we can to assist them in the development of not just readiness for the potential of a pandemic influenza, but for other infectious diseases.

With respect to your question on the proposals, I'd like to ask Dr. Steiger if he's able to comment on that. Otherwise, I'm not able to.

Dr. Steiger: I might say about our flu plan in Latin America, specifically, that we're looking to make investments cooperatively with a number of individual countries that have strong national influenza programs, as well as making investments in regional institutions that have a reach for laboratory capacity, and for training health care workers and specialists. So, in South America, in particular, we'll be making some bilateral investments with Argentina and Brazil, a regional investment through the US Navy Lab that's based in Lima, Peru. In Central America an investment as the Secretary mentioned, with the Gogas Memorial Institute in Panama City, and with the regional platform that we've developed with the government of Guatemala. Then, we're also providing some assistance to the government of Mexico on a cooperative basis, including a program to improve surveillance and laboratory capacity along the US-Mexican border.

Question: And on Kenyan --

Dr. Steiger: On the Kenyan resolution, we're still studying a number of aspects of the report of the Commission on Innovation, Intellectual Property, and Public Health. We'll be engaging in a number of discussions with delegations from Brazil, Kenya, and elsewhere. Our view is that a treaty is not the best answer to improve investments in innovation, and research and development for diseases of the developing world, so we'd prefer not to see such a rigid structure, but we are interested in hearing the ideas of how all of us can work together to produce the next generation of drugs and vaccines that will be needed in poorer countries.

Question: I'd like to ask you some questions about Tamiflu. How much are you producing for the United States for the domestic population? And Tamiflu has a short shelf life in the sense that you have to use it fairly quickly, I think. So how will you be able to disseminate this rapidly enough to the people? How will this be done?

Then you said you sent a shipment of Tamiflu to Asia. Is that right?

Secretary Leavitt: That's correct.

Question: For how many people? And will you be planning to do the same thing for Africa?

Secretary Leavitt: I'm not going to specify the amount or the location, but I do want to make clear that we are beginning to deploy it. The strategic locations will be determined as part of the cooperative deployment I spoke of earlier. That's one of the reasons I think we need to be cooperating or coordinating our investments and our deployment of supplies and other things with other countries.

With respect to our domestic use of Tamiflu, it is our objective to have a supply sufficient for 25 percent of our population, which would take us to about 75 million courses. We anticipate that, by the end of 2006, we'll be at 26 million and, by the end of 2007, we will have satisfied our longer-term goal.

We're in the process right now of working with our states on how it will be distributed, both numerically and logistically.

Question: You've partly answered the question about Tamiflu in response to my colleague's question, but just a further one on that; the stockpile that you've talked about, who does it actually belong to? Is it a US-owned stockpile that you would need to authorize distribution of in particular countries?

Secretary Leavitt: Yes. It is a stockpile that would belong to the United States and we'd control its deployment. It would be done in cooperation with other countries, and again I want to emphasize that's the reason we believe that the pledging conference which was a success at $1.9 billion, we now need to have each of the countries specify where they intend to invest so that we're not overlapping and creating a sense of global coordination.

Question: Mr. Secretary, in your personal letter to the Director General, Dr. Lee, you expressed very strong support for Taiwan's participation in the WHO. My question is: The Health Minister from Taiwan invited his counterpart from China to hold bilateral talks on issues related to epidemic prevention and control. I wonder if the US would try to facilitate or encourage such dialogue?

Secretary Leavitt: I'm unfamiliar with those arrangements, and I would just say my letter stands as it is.

Question: A follow-up to my colleague's question and then I have another question. How would you handle today the issue of Taiwan?

Two, how will you come to the rescue of the Palestinian and Iraqi people?

Secretary Leavitt: With respect first of all to again the issue of the relationship to Taiwan, I think my letter was very clear in stating the position of the United States and the letter stands on its own.

With respect to your second question, that's a matter I would prefer was handled by our State Department. It's not within my portfolio.

Question: [Inaudible?]

Secretary Leavitt: We would be coordinating with the State Department on that issue.

Question: Last year there was some concern that some of your H5N1 slipped into some countries. Have you recovered them? Last year you expressed great concern that they have sort of gone off to countries which we didn't expect and anticipate, and that it poses a danger.

Second, what have you decided about the smallpox viral destruction? Because it's 2002, now 2006. There is still no clear agenda. And have you found any stocks in Iraq? Claims were made there are smallpox viral stocks in Iraq as well.

Secretary Leavitt: Let me first say on the virus you spoke of that I indicated last year a concern about, it's my understanding that it has now been recovered and destroyed.

With respect to the smallpox, our position remains as it has been previously stated, we believe that there is important scientific reason for that virus to continue to be studied and developed. We are working at our Centers for Disease Control to develop improved ways in which we could respond to a reemergence of that virus, and we continue to believe it has important scientific value.

With respect to issues related to Iraq, I'm not qualified to speak on that matter, and would refer you to others within our government.

Question: A question on what you said on the stocks that you deployed in Southeast Asia or in Asia. Is Indonesia one of the countries where there is a concern that it has spread from human to human?

Secretary Leavitt: I'm familiar with news reports but have no scientific information that hasn't been reported. It is, of course, of concern to all of us, and we're monitoring it closely.

Question: Regarding Turkey where there was an outbreak of avian flu recently, there were conclusions that they needed more coordination between the Ministry of Health and the Ministry of Agriculture, that government leadership and clear directions were vital, that it was essential to get communications to women and children, and that the compensation strategy must be clear for culling chickens, particularly in poor areas. Do you have a policy on that?

And I'd just like to follow up on your reply about mega-cities. Clearly, we all know it's a major problem what's going to happen in these massive slums. You say social distancing, but that seems to be unrealistic. What progress is being made towards getting a real solution?

Secretary Leavitt: First of all let me just comment on your last question first. We believe that it is crucial that we begin to develop strategies for social distancing that can in fact work, and we're beginning to model on how, model carefully, and we've actually deployed to four different scientific organizations a series of assumptions asking them to model how best to use, for example, antivirals, where to attack the problem. We're developing a series of models that we'll share with the world as they emerge that we believe could have application in large mega-cities. Now we don't know with certainty, no one knows with certainty, anything other than the fact that if a killer virus is set forward on an unabated basis that it will reap destruction that will be tragic, so we're all working to find ways in which we can be of assistance. If I told you we had the solution, I would be exaggerating.

Your other question?

Question: Compensation.

Secretary Leavitt: Your statements on the need for cooperation between human and agricultural ministries could be made in any country in the world, not just Turkey. It could be made in the United States, it could be made anywhere in Europe, it could be made anywhere. Avian influenza is a bird disease right now. If you're a bird, it's a pandemic. If you're a human being, it isn't. [Laughter.] We need to keep that in mind.

We're spending a lot of time thinking about human influenza, but in reality this is spreading across the planet on the backs of wild birds. The agricultural part of this is where we need to be spending more of our time.

With respect to compensation, again, that's a good reason for our $1.9 billion pledges to turn into action plans that are coordinated. Clearly that needs to be part of our coordinated effort. There needs to be some means by which we can assist in the development of compensation policies.

Question: I was just wondering if you had any revised estimates on when there might be the first bird found in the Western Hemisphere carrying the H5N1 virus, and what are you doing to prepare the public for a possible hysteria when such an occurrence might occur?

Secretary Leavitt: I have spoken extensively on this subject in the United States. There is no reason to believe that the United States will not at some point, perhaps in the near future, see a wild bird with the H5N1 virus on board. You cannot build a cage over the United States. When it occurs, it will not be an emergency. I have met now with the news departments of most of the major networks in the United States to have a conversation on this matter. We are actively exercising plans that, in essence, call for us to flood the zone, if you will, with as much information as possible when it occurs to provide people with information. This is a time for us to be informing, not inflaming. It's a time for us to inspire a sense of preparation, not a sense of panic. It is inevitable in my mind that a bird will enter North America with the virus on board and when it happens, we just need to be able to communicate. Frankly, the news media needs to be asking themselves exactly that question because they will play an important role in being able to communicate what is a crisis and what isn't.

It's possible that it could end up in a domestic flock in the United States. Our Department of Agriculture is actively exercising. Our Department of Interior is focused intensely on wild birds. I suspect at some point it will happen.

Question: Previously there were simulations that said things anywhere from nine to 12 months after it reached Europe. That would mean that it would be six months, five months away. Are there any revised estimates based on previous or present simulations?

Secretary Leavitt: There are no formal estimates but you can look at the fly-ways and say it can happen any time from now until next year. Wild birds are what they are, wild, and they will choose the time and the place.

Question: Thank you very much.

Last revised: May 24, 2006

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