Remarks as Delivered on Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop 2008 & BARDA Industry Day

Thank you, Craig [RADM Craig Vanderwagen, M.D., Assistant Secretary for Preparedness and Response]. It’s always, I’m always appreciative of my work with Craig, and it sometimes seems like the wrong time to return a compliment when one has said something as nice as he did about me. I just want you to know I deeply enjoy our friendship and the opportunity I have to work with him.

Thomas Friedman is a favorite columnist of mine. I enjoy reading his views on foreign policy. I was interested this week to pick up the recent edition of Golf Digest, and I knew that he occasionally wrote on golf, but I found an article by Thomas Friedman. And he was recounting an email exchange between him and Tom Watson, who was apparently a friend of his. He wrote to him saying, “I’m in the club championship.” I think Thomas Friedman is a very good player, and he said, “I need a couple of tips on match play as quickly as possible because I’m in the finals tomorrow.”

So there’s an e-mail back from Tom Watson, who was, at the time, playing in the Senior British Open. He gives him a couple of good tips. One, as I remember it, “Don’t concede putts early or late.” Another one was, “Play the course, not the opponent.” I think the third one was, “Keep the ball in play.”

Anyway, they exchanged back and forth. After the next day, there’s a third e-mail, and it’s from Tom Watson to Thomas Friedman, “Did you win?” He wrote back saying, “I played brilliantly until I got through the 17th hole, and on the 18th hole we were tied,” and he describes the shot, and the bottom line is, he said, “I folded under the pressure,” and described the experience.

Another e-mail back from Tom Watson. He said, “You learned a lesson on 17 and 18 that you will never forget.” He said, “We rarely learn the real important lessons in victory. We often learn them in defeat, and it’s something that you will never forget and a mistake you likely won’t make again.” I thought that was an interesting observation, and something in the context of all the exercises and the things that we do that are important.

I’d like to tell you about a moment for me when I had one of those true galvanizing moments about the importance of preparedness. I was governor of Utah in 2002. We had the Winter Olympic Games. I was at the figure-skating competition on the fourth day. I got a call from the head of public safety saying to me, “Governor, we need you to come to the command center. We've had an incident.” He said, “We've got a problem, and that is we have a positive indication on anthrax at the airport.”

Now, I left the arena moving as rapidly as I could through the crowd without seeming to be panicked. I was told as I walked on my cell phone that a monitor at the top of the C concourse had registered positive. I indicated, of course, “How sure are you?” They said, “We’ve tested it. We’ve not only tested it once, we’ve retested it four times, and it comes up positive each time.”

Now, I knew well what, at that moment, was happening at the Salt Lake International Airport. Not only was this during the middle of the Olympic Games where you had thousands and thousands of people coming, it was the prime time of a hub. About that time, there would be 50,000 passengers that would get off an airplane and walk through the space of that terminal and get on another airplane and they would go to some hundred different locations not knowing potentially that they had walked through a space that had been contaminated by anthrax.

My mind began to work. I thought back about 60 days earlier when we had done a sweep of the employees at the airport and realized that there were some 200 of them that were improperly documented in preparation for the Olympics, and my mind began to put together this sort of sinister plot where someone had placed a cell. They had been there in place, and then the third or fourth day of the Olympics, when the world had gathered for the first time after 9/11, they had released a white powdery substance into the ventilation system and would disrupt in a very spectacular way the world's next great event.

There was a sinister brilliance about this that I could instantly see. It was the kind of dramatic moment when you begin to focus very intensely on what’s happening, and I remember going to the command center and making decisions about what to do. On one hand, if we closed the airport, instantly the Olympic Games would become about terrorism. On the other hand, if we left the airport open, we had the prospect of thousands of people walking through becoming contaminated.

Fortunately, as governor and at the Olympics, I had very capable people from federal agencies who had been pre-positioned there with the possibility there would be an incident like this, and we began to put together a scenario where I brought all of the hazmat teams in, I positioned them, and then I stood outside the laboratory door for about two hours while we waited for the more delineating tests to be made.

Now, it was one of the happiest announcements of the Olympics when I realized when they told me that the more delineating test indicated it was a faulty monitor. That happened more in those days than it does now, but the live-fire exercise that happened caused me to begin to think through what would need to happen in that situation. How could we find the people? What would the protocol be?

I look back on our level of preparedness for that kind of an event then and what we have now, and they are dramatically different. But it was a moment, as I indicated, of live-fire exercise. Very few people heard about the event because it was a false alarm, but the lessons I learned were important. It impressed upon me the need for preparedness. Preparedness is a process of learning. It's a process of adapting and growing. We're facing new threats from new quarters, and we've got to respond in new ways with new ways of working together, and that's what this conference is about.

Through anticipation and through collaboration, we can make the kinds of strides necessary to ensure preparedness against colossal health threats, whether they're manmade or whether they are natural. When I see the difference in our level of preparedness in responding between Katrina and Ike, I can feel the value of the collaboration that's taken place in the last three years.

In truth, we've made a lot of strides. We've seen the creation of the Public Health Emergency Medical Countermeasures Enterprise. The Enterprise provides the core government framework for furthering the medical countermeasures research and acquisition and deployment. We've seen the creation of BARDA. As most of us know here, BARDA manages our countermeasures enterprise and Project BioShield. These help to ensure the development of the necessary vaccines, the necessary drugs, the therapies, the diagnostic tools that we need for medical emergencies.

Through BARDA, HHS funds companies in late-stage development of medical countermeasures. This funding helps bridge the so-called valley of death between the time that we have early-stage NIH funding available until there's actually a product to sell. It gives companies, such as those who are represented in this room, economic support to develop products that wouldn't otherwise have been available to the market.

This, in and of itself, is a form of collaboration. It's a collaboration between government and the private sector. We provide companies with the funding they need to make their venture economically worthwhile, and they bring into existence a product that we need to ensure that our citizens are safe in the event of a pandemic or a bioterrorism attack. Under Craig's leadership, along with Robin, BARDA is committed, as is HHS in total, to continually improving its operation and continuing to improve our capacity to collaborate with all of you.

But I do want to just pause for a moment and talk about some of the things we've already accomplished. We've seen the creation and the licensing of the first vaccine for humans against H5N1 influenza virus. Time Magazine called the vaccine’s approval the top medical development of 2007. BARDA is currently focusing on two of our most pressing challenges in developing countermeasures: developing a second-generation anthrax vaccine and developing the drugs that people need if they're exposed to radiation.

And we've now proceeded to have 26 million doses of the H5N1 vaccine. Our stockpile is available to support clinical trials and to protect physicians and first responders in the early stages of a pandemic. We know that the vaccine isn't a perfect fit for ultimately what would become a pandemic, but it will help; and we plan to buy additional doses of pre-pandemic vaccine this fall.

Importantly, we've seen the development of cell-based influenza vaccines. As all of us know, vaccines are traditionally produced by chicken eggs, and we have worked hard with the investment of nearly a billion dollars into the development of the capacity to develop vaccines through cells from mammals, such as kidney cells. This is a major breakthrough in the vaccine technology, one that enables vaccines to produce in much greater quantities and at much lower cost.

Now, may I say, this is not just an important breakthrough for those of us in the United States, this is a global achievement of note. If we were having to deal in a world with a virus that was moving across the planet, there would be such disruption looking for vaccines, you could put every chicken on the planet into service and we wouldn't be able to grow enough eggs to create vaccines for this earth.

However, with cell-based, that becomes far more achievable, and this is a very important achievement. People who are exposed to radiation likewise need to have their bone marrow jump-started quickly against life-threatening infections. We're encouraging the development of drugs that can make that happen. And the second-generation anthrax vaccine that I mentioned is a step toward preparedness in the case of a bioterrorism attack like the one I described.

With the necessary congressional funding, BARDA will, I am sure, see further successes along these lines, and I want to say publicly that I very much hope that Congress will preserve the special reserve fund that's intended for this use. The special reserve provides funds from BioShield and other countermeasures, and I hope that Congress will avoid the temptation to take money from that fund and to spend it on other projects. These are important projects.

In addition, the successes in developing the medical countermeasures that we've seen increase preparedness for state and local entities. With federal help, we have been able to assist 22 million courses of influenza antivirals that have been purchased by states. We've held summits in nearly 50 states on pandemic and all-purpose readiness. I attended most of those myself, and may I say I thought they were inspiring events. We brought health professionals, schools, the private sector, and local government together and put forward a very important message, and that is that any community that ignores the need for preparedness with the expectation that somehow in that moment of a pandemic the federal government will be able to provide needs for everyone, they're going to be sadly disappointed, not because we lack the will or the wallet but because there's just no way to serve everyone at the same time. And as Robin pointed out, I have continued to press forward on the need for individual preparedness.

One of my favorite summits was the Wyoming summit. After I had delivered my message of individual preparedness, a woman said, who was a reporter, "So how do you go about preparing?" I said, "Well, having some food and some water and some things stored," "Well, it's expensive to have food, and not everyone can afford that," and I said, "Oh, it's not all that difficult." I said, "If you're going to the grocery store and you're going to buy a gallon of milk, by a carton of powdered milk and stick it under your bed. If you're going to buy four cans of tuna fish, buy five and put one of them under your bed." I thought it was pretty good advice.

So did Jay Leno. It was picked up somewhere, and so the next night, he said, "So did you hear about the Secretary of Health saying that we ought to have a case of powdered milk and tuna fish under your bed? He said it's for the flu." He said, "Tuna fish and powdered milk, I'd rather have the flu."

Then he said the next night, "So you hear about Leavitt and his need for a pandemic plan and individual preparedness?" He said, "He says you ought to put tuna fish and powdered milk under your bed." He said, "If that's your idea of a pandemic plan," he said, "you can just star-kiss your ass goodbye."

Then the next night, he said, “You hear about the pandemic plan?” He said, "A little powdered milk and tuna fish under your bed." He said, “Tuna fish and powdered milk,” he said, “Isn’t that what Red Lobster calls clam chowder?”

Well, 50 summits, and we got the word out between Jay Leno and me on individual preparedness.

Subsequently, we’ve been continuing to work with the states, and we have led communities to update their pandemic influenza plans, and we have plans across the country. We're better prepared today than we were three years ago. We have a lot of work to do still, but the good news is it's bringing our entire federal level, our state level, and we're stockpiling. We're making significant progress, though we have much to do.

Collaboration and anticipation are the key. Every aspect of society, whether it's the federal government, the state government, the local government, the private sector, community groups, families, individuals — all of us have to share in the responsibility to prepare for a bioterrorism attack or an influenza pandemic. Public and private collaboration is critical to expanding the medical stockpile measures. It’s critical to our overall preparedness, and that’s the reason we're here today.

In the whole realm of health safety concerns, there is a constant, and that is that we have to rely on each other. We need all hands on deck and more, and we're working in unison. We're going to be better prepared if we do, and we'll make great strides.

So thank you for coming to the conference, and we look forward to a productive future and more collaboration. Thank you.

Last revised: January 12, 2009