Previous IFPA-Fletcher Conferences

National Security Strategy and Policy:
Planning for and Responding to Threats to the U.S. Homeland

October 28-29, 2004
Ronald Reagan Building
and International Trade Center
Washington, D.C.

Dr. James M. Hughes, M.D.
Director, National Center for Infectious Diseases
Centers for Disease Control and Prevention

Introduction By: Dr. Charles M. Perry

Dr. James M. Hughes: Good morning, I'm Jim Hughes from the Centers for Disease Control and Prevention. I'd like to thank the organizers for the opportunity to be here with you for this very timely discussion.

I'm going to move quickly and touch on several themes -- public health surveillance, response, research, partnerships, communications, and lessons learned. These have been alluded to by the first two speakers this morning and came up to some extent yesterday.

I'd like to put this in the context of infectious diseases generally. This initial slide shows you two very important Institute of Medicine reports. The first one, on the left, really highlighted the concept of emerging infectious diseases. This report, published in 1992, was developed by an expert committee that was led by Nobel Laureate Dr. Joshua Lederberg and the late Dr. Robert Shope.

On the right is a recently updated version of that original report. This new report, published in 2003, was developed by an IOM committee again co-chaired by Dr. Lederberg but joined this time by Dr. Peggy Hamburg, the former Commissioner of Health of New York City. Now, you may not recognize the organism on the 2003 report because of some artistic license taken with it, but that’s influenza virus, and it’s there on purpose.

These reports highlighted the infrastructure problems that General Dodd just mentioned that have developed in the United States in terms of our capacity to deal with infectious diseases. The committees also made an important contribution by identifying factors that contribute to the emergence and reemergence of infectious disease. I'm not going to discuss these in detail for the sake of time, but the initial committee identified six factors: human demographics and behavior; technology and industry; economic development and changes in land use patterns; international travel and commerce, think of SARS in that context; microbial adaptation and change, which is what make infectious diseases unique and particularly challenging; and, finally, the breakdown of public health measures.

The more recent committee ratified these six and then added seven more: human susceptibility to infection; changes in climate and weather; changes in ecosystems; poverty and social inequality; war and famine; lack of political will; and last, but certainly not least considering the important issues we’re dealing with here at this conference, the intent to harm, which was really not discussed at all in the 1992 report.

Now, you may recall the amazing and surprising introduction of West Nile virus into the Western Hemisphere, where it was recognized for the first time in August of 1999 by an alert infectious disease physician working in Queens. These are two op-ed pieces that subsequently appeared in the New York Times, raising the question of whether this was a natural epidemic or a terrorist attack. The whole West Nile virus experience reminds us that we do indeed live in a global village and that, from an infectious disease standpoint, we also have to worry about what’s going on in other parts of the world. There was no evidence at the end of an overall investigation to suggest that West Nile virus was purposely introduced into the United States.

But, as we all know, everything changed on September 11th, and again about three weeks after that following recognition by an alert infectious disease clinician working in South Florida of a bioterrorism attack. An alert physician in the middle of the night did a lumbar puncture on a very ill patient. A person working in the clinical laboratory saw a very dramatic spinal fluid gram stain. The clinical laboratory worked with the state public health laboratory in Florida and rapidly moved to recognition of this first case of inhalational anthrax. Local, state, and national public health officials and many, many others rapidly became involved, as you know. But, this initial case reinforces the point that a terrorism attack is likely to be recognized when a patient shows up ill at a local level.

This slide shows the report of this case from Dr. Larry Bush and colleagues that appeared in the New England Journal of Medicine. This was a very tragic attack, and resulted in 22 cases and five deaths. It could have been much worse, however, as this next slide indicates. The attack could have involved multiple agents or drug-resistant organisms, which might have been genetically engineered, or could have involved transmission to animals. There also could have been multiple modes of transmission; as far as we know, the organisms were disseminated only through the U.S. postal system.

Clinical surge capacity, treatment capacity, or lack thereof was not stressed in this attack because of the small number of cases in multiple geographic areas. Although it was a national problem, the cases occurred all in the Eastern time zone. This was in dramatic contrast to the experience in dealing with SARS, I might point out, which was a global problem. With the anthrax attacks, there were no cases in other countries, and, thankfully, there was no associated cyberterrorism.

While not relevant to the organism that causes anthrax, use of another organism of concern in an attack could have resulted in additional issues to confront such as the organism being difficult to isolate or identify in the laboratory. With other organisms, there are also concerns about person-to-person transmission which was not the case with anthrax. And with some other organisms, there is the concern about transmission by vectors.

Terrorists are out there, and so are the microbes. As a result of a number of these recent experiences, a new public health perspective about infectious diseases has developed. This slide depicts one of the anthrax letters sent, people impacted by SARS, and concerns about avian influenza and the next flu pandemic that General Dodd mentioned.

It’s now much better recognized than it was ten years ago that infectious disease outbreaks can impact national security and the global economy. Local outbreaks and problems are recognized as having potentially much wider implications, and rapid and collaborative responses are absolutely essential and certainly expected.

CDC’s bioterrorism program, begun in 1999, involves many components of the Agency. This program stresses this concept of dual or full use that has been mentioned. We focus on preparedness planning; epidemiology and surveillance; strengthening biological and chemical laboratory capacity; improving communications, which is crucial; education and training; and development of the Strategic National Stockpile.

A lot of thinking has been done about what are the bioagents of greatest concern. This slide shows the so-called Category A agents and the diseases that they cause. One thing that’s important to recognize here is that those causing anthrax, plague, tularemia, and almost certainly the hemorrhagic fevers are of animal origin. These infections are what we refer to as zoonotic diseases, with which the veterinary world has a lot of experience. As we talk about the need to strengthen partnerships and work across disciplines, it’s very important that we not overlook our veterinary colleagues.

Now, there are a number of ongoing bioterrorism preparedness initiatives that are probably familiar to you, but I wanted to mention three briefly: BioSheild, the countermeasure development program focused on vaccines, therapeutics, and diagnostics; BioWatch, which involves deployment of environmental air samplers in key locations to detect releases of biological agents and is supported by the Laboratory Response Network, which I’ll mention a bit more about in a minute; and then finally BioSense, a public health surveillance approach involving enhanced detection of bioterrorism by accessing and analyzing diagnostic and prediagnostic health data.

This slide illustrates the geographic locations of laboratories participating in the Laboratory Response Network. Each state has at least one. These laboratories certainly demonstrate the capacity for dual utility. The images shown on the bottom indicate how the LRN played an important role in dealing with the anthrax issues, with SARS, and with the recent introduction of monkeypox into the U.S.

The Laboratory Response Network involves agent-specific protocols, standardized reagents, a lab referral directory, a secure communications system, training of personnel, proficiency testing, and provision of appropriate immunization to laboratory staff participating in this network.

Now, quickly, here are some specific examples of contributions made by this network. PCR is polymerase chain reaction, a nucleic acid amplification technique for rapid sensitive diagnosis. The LRN laboratories participate in the BioWatch program, and have the capability for detecting viral and major nucleic acid in clinical specimens. They also played an important role, as I mentioned earlier, in evaluating specimens from patients suspected of having SARS once diagnostic tests were developed and distributed. The LRN labs in the states impacted by monkeypox were also provided with diagnostic reagents for monkey pox.

I also briefly mentioned the Strategic National Stockpile. This program consists of two components. Twelve-hour push packages, one of which is shown there at the top of the slide, are maintained and can get anywhere in the country within 12 hours. One of these push packages was deployed for the first time to New York City on September 11, and arrived in 7 or 8 hours. You do want to be sure you need one of these push packages before you ask for it, because each one fills a 747 and is a little hard to send back. While you cannot tailor that component of the stockpile to your specific need, the other component, the Vendor Managed Inventory, can actually provide the specific treatments, vaccines and diagnostic supplies that you need, although not as rapidly as the push packages.

Now, as you know, there are many research issues in the biomedical world related to bioterrorism preparedness and response. This slide shows a commentary by Dr. Tony Fauci from NAIAD that appeared in Nature last year that provides an overview of these issues. In dealing with the aftermath of the anthrax attack, we recognized the importance of environmental microbiology. From a research standpoint, many of these agents have been neglected over the years, and there are a lot of issues, including some very difficult but important environmental issues, that surface when you think about scenarios in which these agents might be used.

NIAID has awarded funds to eight regional centers of excellence involving academic and other institutions for research on biodefense and emerging infectious diseases. The color coding in the slide shows you the areas in which these rather unique consortia are located.

Now, with research in this arena, of course, come some dilemmas. I hope those of you who think about these issues are familiar with the so-called Fink Report issued earlier this year by a committee chaired by Dr. Gerald Fink, under the auspices of the National Research Council. This report talks about examples of experiments that raise concerns, such as those demonstrating how to render a vaccine ineffective, confer antibiotic resistance to therapeutically useful agents, enhance the virulence or the capability of an organism to cause disease, or, worse yet, render a nonpathogen virulent. Also included are experiments that might increase transmissibility of an agent or alter its host range, those that would enable evasion of diagnostic or detection modalities, and certainly those that would enable weaponization of an agent or toxin.

Now, to begin to wind down, I’d like to briefly discuss some important lessons learned from recent experiences. There have been many. This slide shows an editorial from the Journal of the American Medical Association that makes the important points that clinicians and public health agencies are essential partners at the local level and that these partnerships should be strengthened. As I mentioned earlier, we need to engage the veterinary world in our efforts to address infectious disease threats. This is an interesting quote from Dr. Lonnie King, Dean of the College of Veterinary Medicine at Michigan State University: “We have a new world in terms of the epidemiological convergence of animal health and human health. It’s an epidemiological collision.” Some examples of recent emerging infections that are zoonotic are shown on the right. As you can see, plague, one of the Category A agents, is listed.

The importance of international partnerships is obvious. Shown at the top is the SARS diagnostic laboratory network put in place by the World Health Organization. This collaboration was critical to identifying the cause of SARS and subsequently to worldwide control efforts. Also shown is the WHO Collaborating Centers for Influenza. As we worry about avian flu and the next influenza pandemic, this network is extremely important. You can see there are important gaps in that network shown in the gray area on the slide.

Then last, but certainly not least, is the importance of proactive communication. It’s no secret that there were lots of communications problems associated with the anthrax attack. Dr. Walks has already referred to some of those. I think progress has been made, though there’s certainly more work to do. At the top of this slide is a photo of Dr. David Heymann and his WHO colleagues at a press conference during the SARS outbreak.

This is the last slide. It allows me to reinforce the importance of vigilance. As we put more and more sophisticated detection systems in place, we must not undervalue the important role that is played by alert clinicians, alert laboratorians, alert veterinarians, and alert research scientists in recognizing and responding to these threats.

Thanks very much. [Applause]

Questions and Answers

JIM NICKERSON: Good morning. Jim Nickerson, public health officer from Boston, and previously with the DoD research community. Several of the panelists here underscored the need for a comprehensive emergency communications plan, and Dr. Walks this morning, his final slide underscored the need for informed caring, careful and redundant leadership. If each of the panelists could comment on some of the qualities of skills and leadership, both local, state federal and communicating during national emergencies such as the anthrax attack here on the Capitol. I'd be interested to hear the perspective on how best to coordinate local and federal comprehensive communications plan, and what best practices there may be there in terms of exercises that have already occurred.

DR. HUGHES: I can take a quick, initial stab. Others will want to comment. I'm sorry Dr. Walks isn't here, because he could speak from the local experience here, but I think Mayor Giuliani in New York City was really a hero in dealing with this aspect of the problem. He’s a highly skilled risk communicator. He had frequent updates for the media. He had technical experts at his side as he did those briefings. He said what he knew and what he didn’t know, and what was being done and what people should do until additional information was available. I think that’s a model.

__: I understand this is a bio defense session, but I'd like to ask also about the nuclear, radiological and chemical response plans, because we really have only one medical community. I was interested to see the planning and actual funding of a national stockpile of bio defense agents, 747s full of push packages and vendor inventories, and I'm wondering who is stockpiling the radiological medical treatment that would be required for 100,000 deaths and 300,000 injured as a result of the ground burst nuclear attacks that were discussed yesterday, particularly given that the NORTHCOM Command Surgeon says that DoD is not going to fund things over and above what DoD needs for its own force protection. Who’s going to fund the radiological stockpiles?

DR. HUGHES: Obviously, I'm focused on the biologic side, so I cannot comment definitively in response to your question, which would be better directed, perhaps, to another panel. But, there are components of the CDC stockpile that have some antidotes for chemical exposure. The problem is you need those locally right away when something happens. I know that there are ongoing discussions regarding making supplies available at the local level should there be a radiation exposure, but I haven’t been involved in these discussions. I just can’t be more definitive.