Symposium sponsored by:

Johns Hopkins Center for Civilian Biodefense Studies

Department of Health and Human Services

Infectious Diseases Society of America

The Problem of Biological Weapons: Next Steps for the Nation
Tara O'Toole, MD, MPH

DR. HAMBURG: Our next speaker will close. This particular panelist is somewhat familiar to all of you -- Dr. Tara O'Toole, the Deputy Director of the Johns Hopkins University Center for Civilian Biodefense Studies. From that role, she has been a very important voice and a true galvanizing spirit across a number of important issue areas for bioterrorism. I think she cut her teeth in dealing with complex, highly charged, and often seemingly insoluble problems during her four-year tenure as Assistant Secretary of Energy for Environment, Safety, and Health, where she dealt with such difficult problems as studying major safety and environmental hazards at the nation's nuclear weapons complex and taking action to reduce those risks; developing the Department's first nuclear safety rules and professional enforcement office; and leading a multi-agency task force that oversaw the government's investigation into human radiation experiments conducted during the Cold War. She also has experience at the Congressional Office of Technology Assessment and is trained in medicine, board certified as an internist and an occupational medicine physician, and brings all of these many experiences and perspectives to her work. She is going to talk to us about her vision for next steps for the nation as regards to the threat of biological weapons.

(Applause.)

DR. O'TOOLE: You've been a very attentive audience. I want to acknowledge at this point the people who carried the burden of the logistics implementation of this meeting, a task that at times was comparable in complexity to managing a bioterrorism attack. Sandy Harwood -- would you folks stand up, please? Sandy Harwood of the Infectious Disease Society of America, and Andrea Lapp of Johns Hopkins, were the extraordinary event managers for this. You can stay standing. Tim Holmes, Molly -- where is Molly? Molly DeSopo, as well as Monica Schoch-Spana, and a very able group of Johns Hopkins students have helped us out tremendously. Please give these people a hand. They're why you are here.

(Applause.)

Great job. For the next few minutes, I'm going to try and weave ideas together from previous speakers, along with some thoughts of my own and those of my colleagues at the Hopkins Center into some proposals for where the nation needs to go -- the top of the list that we think we have to accomplish in the next two years in order to deal with the problems of bioweapons and bioterrorism. But, first, I want to stand back for a moment and consider the larger context of the bioweapons problem, once again.

Where do we stand at this point, at this moment in history? You know, this question is, of course, much on the minds of Americans of voting age these days. The future is not yet written. The votes may or may not be counted. They may or may not count. But at least to some degree the future is ours to compose. Some of the major struggles before us are clear. Among the principal challenges of our generation is the imperative need to manage the adverse consequences of the powerful technologies we have created. At the top of this list are nuclear and biological weapons.

Biological weapons are in the world. Let us be clear: the efficacy of these weapons and their ability to kill large populations has been known for decades and demonstrated persuasively by all possible means short of the use in war or an actual bioterrorism attack. And there is evidence that at least in Iraq bioweapons may have been used on a small scale there. What has been largely overlooked in the complaints about the lack of a quantitative threat analysis, and arguments about how many microbiologists a terrorist must know to build a truly scary weapon, is the trajectory of biological science in these times.

As George Poste said in his remarks, we are on the threshold of the age of big biology. The momentum and pace of this Cambrian explosion of biological knowledge are prodigious. And as our understanding of molecular biology expands, as we develop the ability to manipulate cellular processes, we will also inevitably create the tools to build more varied and more powerful biological weapons. At the same time, the widespread use and market forces will ensure that the techniques needed to exercise this knowledge will become simplified and more widely accessible. Consider, for example, the effort underway to derive infectious influenza A virus from viral complementary DNA. This has been chronicled in prestigious scientific journals for the past year or so, and the work has progressed to the point that infectious virus can be generated from only eight plasmids. A year ago, a minimum of 17 plasmids were required, and earlier methods of producing the virus from the cloned DNA were far slower and more cumbersome than is the case today.

Now, these methods are a great boon to researchers struggling to thwart another influenza pandemic. But this work has a very obvious dark side. A senior researcher concerned about the implications of this achievement and the relative ease with which an influenza might be crafted, recently wrote the Center and noted that the current joke among molecular biologists is not only can a high school student construct such a weapon, so can the janitor of the school.

Those who are still bothered by the lack of quantitative threat estimates for delivered epidemics should also consider that the risk from natural epidemics of infectious disease is increasing at this point in history. Why is this? Well, an increasing proportion of the world's six billion people live in large cities. Before 1950, only London and New York had populations of over seven million. Now, there are over 15 mega cities which harbor more than 15 million residents apiece. Half of these are in the developing world where poor sewage, overcrowding, inadequate nutrition, lack of clean water, and living conditions which place humans and animals in close proximity create almost ideal environments for breeding harmful pathogens.

The forces of globalization offer efficient conduits for the spread of disease. International transport of people and goods by jet is routine. In the 1918 flu pandemic, it took four months for the virus to circle the globe. That was in an era of cargo ships and trolley cars. Today, a deadline virus or bacteria can traverse the planet in a day. Globalization has also created vast networks of food distribution which allow widespread dissemination of tainted products and greatly complicate efforts to prevent contamination. Further, the pressures of population growth and commercialization have fueled human intrusion into once remote ecosystems, increasing the chances of contact with previously unknown and potentially dangerous viruses and bacteria.

And, finally, the natural evolution and mutation of microbial pathogens abedded by imprudent prescription practices and inadequate public health have ensured that drug resistance must now be factored into strategies to contain infectious disease.

All of these factors present a context that demands urgent attention be paid to the perils of biological weapons and epidemic infectious disease. If we awaken to where we are and where we are headed, if we take prudent steps to manage the technologies we have created and the conditions we have made for ourselves, we may forestall the most calamitous bioweapons scenarios. But this moment of relative calm and prosperity we now inhabit will not last.

Now, in the past two years, as you've heard today and yesterday, much has been accomplished. The Department of Health and Human Services has assumed a leadership role in preparing the nation to respond to a bioweapons attack. Programs run by CDC and the Office of Emergency Preparedness have initiated critical programs at the state level and provided essential support for the beginnings of state response infrastructures. Now, these efforts are incomplete and imperfect. This is natural, as Richard Falkenrath pointed out, in beginning big, complex programs. Of course, much remains to be done.

What I would like to do in the remaining minutes is suggest seven issues related to bioweapons preparedness and response in prevention, which I think are in need of particular focus and investment. First, government investments must be commensurate with the threat. In this country, elected leaders show their seriousness about an issue by the way they talk about it, and the amount of money we spend on it. If biological weapons constitute a serious national security threat, then we should be investing some serious money in this problem.

Now, the customary number given for bioweapons defense expenditures in this fiscal year is 1.4 billion. And in health terms, this sounds like a significant amount of change. But seen in the calculus of defense spending, this is peanuts. The fact that, as Amy Smithson pointed out, we are devoting only 0.0046 percent of the 260 billion defense budget to assuring that the talents of bioweaponeers from the former Soviet Union are directed towards peaceful ends is telling and wrong.

Another good place for the next Congress to start demonstrating its commitment to take the BW threat seriously would be to appropriate funds for the Kennedy-Frist Public Health Threats and Emergencies Act, which authorizes up to 500 million in spending to improve public health infrastructure but does not yet have money attached to it. We need an appropriations bill.

Second, we need a very significant biomedical R&D program. We need a focused, fast-track effort to produce new vaccines and drugs, especially antiviral agents, to combat the most likely bioweapons threats. And we need to develop technologies that enable rapid and reliable lab diagnosis of BW pathogens. In the longer term, we should take on the big problem of infectious disease, and, in collaboration with international partners, try to develop ways to enhance immune resistance by means more elegant and multipurpose than the one bug/one drug approach. We need, in short, a Biomed Apollo Program. And Apollo, you may recall, was actually the God of healing. In the first nuclear age, to use Professor Bracken's phrase, we went to the moon. In this era, let's find out what Planet Earth would be like without malaria or AIDS or the threat of a big bioweapons epidemic.

Now, we should create an R&D map for such a Bio Apollo Program that charts where we are and where we want to get to, and creating this map should be the responsibility of technical agencies in government with strong input from scientists from universities and big pharma and the biotech industries.

As Amy Alving's talk on sensors demonstrated, it is very important to have a clear analysis of what we want to accomplish when we embark on a search for new technologies. And if you don't have that clear understanding of the functional requirements of what you're trying to build, you'll end up funding a lot of sensors that don't work outside desert environments.

Next, there are four items on my list needing attention, all of which pertain to building integrated systems or organizational networks or making key institutional connections. Many speakers have commented on the institutional fragmentation that besets many aspects of current epidemic response. Problems linking local, state, and federal efforts, connecting multiple hospitals into a community-wide network, disconnects between medicine and public health, the disengagement of positions from preparedness efforts, were among the many disconnects that got mentioned. These problems -- creating new systems -- is a matter of changing or building organizations. This is important work, but it is very hard, and it is going to take time and persistence. And we need to realize that, so that we don't get discouraged.

Now, the talks offered a cornucopia of principles and practical suggestions for creating organizational change or forming such systems, and I want to quickly highlight some of these, before I get to the actual projects. Jim Bentley, John Bartlett, and Laurie Garrett all cautioned on the need to pay heed to the social values and needs of the community you're trying to interact with. Hospital staff are going to need assurances that their families are taken care of, if we want them to show up at work on extra shifts. Doctors are mostly likely to pay attention to messages from other doctors. And we need to recognize that members of the media have jobs to do that are also important. Martin Hugh Jones observed that the success of PROMED was due at least in part to the accountability and transparency that was built into the system.

Dual use, the importance of dual use, was mentioned many times. This is critically important in constrained budgets, and all budgets are constrained. We need to look for opportunities to build systems and find solutions to bioweapons response problems that also serve routine organizational purposes. Public health management of West Nile Virus and the broad societal benefits from biodefense R&D are examples of dual-use applications.

Things usually look like a muddle in the middle when you're involved in complex projects. Richard cautioned us that it's not normal for new, complicated programs to take time to become established. And D.A. Henderson is always telling us that the small pox eradication campaign at midpoint had generated a lot of energy and excitement, but he couldn't tell yet if it was going anywhere.

So we have to have courage. We have to realize this is going to take time, and we also have to have some sympathy and evidence, and be generous towards those who are in the midst of trying to make these organizational changes happen. Keep this in mind the next time you have the urge to go up to some federal or state official and explain to them what they are doing wrong or have not yet done.

So with those organizational building principles in mind, here is what I think the essential systems-building and critical connections projects we ought to focus on are.

First, repair the medical-public health interface. As Marcie Layton pointed out, strong relations between clinicians and public health professionals are key -- key, key, key -- and essential to outbreak detection. The West Nile Virus might never have been discovered but for a concerned ID doc who called the Health Department and was fortunate enough to connect with a very competent public health professional who answered the phone and took action.

Next, we should focus on creating a robust electronic system for tracking and managing disease outbreaks once they are detected. Marcie also noted that managing the huge volume of information that was coming across the Health Department's desk during the West Nile outbreak was the biggest challenge they faced. We are very wary of spending scarce resources on extremely ambitious and expensive efforts to invent elaborate surveillance systems for purposes of detecting BW attacks. We need to try to do this, but we should proceed cautiously. As Jeff Koplan said, many public health professionals at the state and local level these days don't have computers on their desks. Let's at least get them plugged in to computer networks that are comparable to the ones their kids are using to order from Toys 'R Us before we try to build the great electronic surveillance system in the sky capable of finding bioweapons needles in haystacks of background noise.

Next, we should build surge capacity in hospitals and health care facilities, and the goal here should be to create community-wide response networks designed to accommodate mass casualties brought about by deliberate or natural epidemics and other natural disasters. This will require, first, money to allow hospitals to do some planning. To start, we might consider competitive grants to develop practical templates for an intra-institutional response. We might also develop some grants for consortia of hospitals and HMOs and health departments to look at ways of integrating multiple facilities into community-wide or regional response networks. In the end, we're probably going to need a suite of incentives and possibly regulatory penalties to create the surge capacity and response network that we need. Some aspects of this may be truly expensive, and we need to be very careful not to just put another unfunded mandate on top of the financial pressures that hospitals are already struggling with.

Next, containment of contagious disease. I'm not going to say much about this because I think this is still in the consciousness-raising and just scratching our heads and figuring out what-the-heck-are-we-going-to-do-and-how-are-we-going-to-do-it stage.

Lastly, in the prevention column, I mentioned that we have to find ways to support bioweaponeers in the former Soviet Union in their quest to earn a living and use their talents for constructive purposes.I have not heard or read of any plan for international control of biological weapons that compares in boldness and coherence to that put forth last night by Ambassador Butler, and would urge that we strive to get his idea of making the development of, or possession of, a biological weapon a crime against humanity considered and discussed at the highest levels of as many governments as possible. Many in this audience have direct access to these levels.

Now, even these few elements of the bioweapons program which I'm suggesting as priorities are ambitious undertakings. The whole catastrophe of biological weapons is immensely complex, clearly beyond the reach of any single organization or institution, or even an entire professional community to shape or control. Researchers from multiple disciplines, public health practitioners, clinicians, government officials, people from academia and industry, and from many countries and international organizations, will have to participate if we are to successfully manage the problem of biological weapons.

As individuals, we must each do what we can, as we judge proper. We cannot wait until we have finished some master plan before we jump in. And we must not get discouraged by the weight and the complexity of the task. So here we are. It's Wednesday afternoon. A moment in history when the world is struggling with what to do about biological weapons. Those of us in this room -- well fed, well educated, and free as we are -- are among the most privileged people on the planet. What remains at the end of the day, at the end of two rather long days, actually, is to answer the question: A year or two or 10 from now, what will we say we did about biological weapons? About the greatest threat of our era? I am hopeful that our answer will reflect honorably on our efforts, and I look forward to working with you in the future.

Thank you for your attention.
(Applause.)