Pandemics, Bioterrorism, Public Health, and the Law
Law 801: Health Care Law Seminar
Professor Vernellia R. Randall  


Excerpted From: David R. Franz, The New Battlefield in our City Streets: The Epidemiology of Biological Terrorism in the US  and Some Thoughts on the Way Ahead 201-215 (2002)

DavidFranzThe last 60-70 years of the twentieth century might be called the modern era of biological warfare's During this period, nation states developed biological weapons to be used on a far-away European battlefield Even after ratification of the Biological Weapons Convention of 1972, the most impressive BW program in the history of mankind continued for 20 years, effectively cloaked in secrecy's Yet between 1970 and 1990, little thought was given to the possibility of a biological warfare or biological terrorist attack on US cities Funding for biological defense in the US was minimal and most of the federal government was oblivious about the threat 

In fiscal year 2000, the US government has committed more than $1.5 billion to military biodefense and another $1 billion to domestic preparedness for biological attack What happened In 1991, the US decisively engaged the Iraqi force, demonstrating vast conventional technical superiority while the world watched on CANN Shortly thereafter, with economic implosion in the Former Soviet Union, our concern turned to the fate of tens of thousands of Russian scientists and engineers who had developed an impressive program which may never be surpassed in scale or offensive capability We feared that lesser nations might turn to now jobless Russian bioweaponeers for help in building their great equalizer. All this occurred with a backdrop of increasing evidence that the dual-use nature of bioweapons programs might make treaties unverifiable. Here at home, the equally dual-use biotechnological revolution screamed forward while novels imprinted the horror of bioterrorism on our minds and experts proclaimed that there are no technical solutions What can we do?

There is no silver bullet Our best deterrent and response to the unknowns of bioterrorism must be a broadly integrated defense founded on a deep and sustained biotechnical base The solution does not lie in procurement of things: safety equipment, clothing or gadgets for fire services or police If preparation for chemical terrorism is HAZMAT equipment, treatment in the streets and a cordoned-off crime scene; preparation for biological terrorism is education, a robust public health system and broad interagency collaboration The integrated system must include intelligence and forensics, the means and the will to retaliate, medical and physical countermeasures and strong public health infrastructure, all bound by vigorous interagency collaboration and effective educational programs We face a very complex problem; one of low-probability, but potentially high-impact Calling for a Manhattan Project may actually be under-response. What must we do?


1.        Technological base: We believe that we understand the relative limits of nuclear physics and chemistry, but we do not understand the limits of biology---for good (medicine) or evil (biowarfare).Ý The future biological warfare or terrorism threat is relatively unknown; therefore, it will be difficult, especially in the medical arena, to prepare specific countermeasures for all threats We must be capable of responding quickly and effectively to the unknown; therefore, our technical base must be deep and broad There is not a military-industrial complex for biological defense as there was for our nuclear weapons and energy programs We must strengthen our military tech-base for threat evaluation, pathogenesis and specific medical countermeasures research We must expand and leverage non-military government public health research, especially in the areas of immunology, diagnostics and drug development We must increase our support to academic research and partner with industry for advanced development and production of orphan vaccines and antiviral drugs All of these efforts will provide more spin-off application to public health than we typically expect from defense research Finally, we must demonstrate that we are in this battle for the long term.

2.        Intelligence Intelligence for bioterrorism is extremely difficult because of the dual-use nature and minimal signature of the weapons programs Facilities, equipment and human resources for the R&D and production of biological agents are not unique Even weaponization and dissemination---especially for the terrorist---can be done with equipment from legitimate industry Precursors are not unique and signatures are non-specific, rapidly diluted or destroyed in the environment or nonexistent Maintaining quality expertise in our intelligence analyst corps is proving difficult because of competition from industry for our best young scientists and the mundane aspects of the analyst's job On the other hand, the new openness fostered by information technologies and the spread of free enterprise biotech throughout the world offer new options for information mining We must not only use these technologies to better understand the threat worldwide, but to better use human sources which are more plentiful in the era of increased mobility.

3.        Forensics capability: While diagnostic capabilities are paramount in responding medically to an attack, attribution following bioterrorist attack will require exquisite forensics capabilities We must be capable of quickly dissecting an organism at the molecular level More importantly, people who are familiar with the epidemiology and laboratory characteristics of strains and isolates from around the world, and who work with these agents daily, must do this work Obtaining the complete genetic fingerprint of an agent used in a biological attack will never be as good in the world court as matching rifling marks on a bullet with the criminal's firearm, but without this information we won't have a clue Even in preparation, what we learn about the genomes of the biological agents of concern will have application in basic science and public health.

4.        The will to retaliate: The way we respond to the first use of biological agents against our citizens, even if it is not a mass-casualty event, will likely set the general course for our future interplay with the biological terrorist The Israeli model for defense against airline hijacking---granted a less complex problem than we face here---has proven effective: vigilant, integrated, uncompromising and swift We must take the most extreme measures against known proliferators and users of biology to harm our citizens; their clear understanding of our resolve will serve as a deterrent.

5.        Medical countermeasures: Protecting civilians from bioterrorism is more difficult than protecting a military force For the force, we can use 1) active immunization for some agents, 2) passive immunoprophylaxis and chemoprophylaxis for others, 3) battlefield detection systems, 4) physical protection (masks), 5) identification and diagnostic tools and methods, 6) decontamination procedures, 7) passive immunotherapy and 8) chemotherapy For an attack on our citizens, our useful countermeasures begin with identification and diagnostics and essentially end with chemotherapy.


Identification of the agent used in an attack is of critical importance Without this, rational post-exposure prophylaxis will be futile Diagnostic capabilities must be ready in the field, throughout a network of hospital and government clinical laboratories and in key national reference laboratories. Classical and molecular methods must be known and validated. Triage may be critical to success in therapy of the right subpopulation Humans exposed, even to replicating agents, will not have measurable amounts of the agent in their blood or serum for several days at the earliest, nor will they have a measurable immune response Yet, humans---or domestic animals---may be the only sentinels at the site of the aerosol attack Therefore, methods of preclinical diagnosis must be developed.

We must consider stockpiling antibiotics effective against anthrax, pneumonic plague and tularemia Today, neither antiviral drugs for smallpox nor vaccines for the two agents----smallpox and anthrax---for which they might be needed post-attack, are available in sufficient quantities to allow stockpiling. We must leverage industry and academic research for antiviral drugs, which target selected threat agent active sites We must develop adequate stocks of anthrax and smallpox vaccine Most experts believe that ventilators are likely to be in short supply after an attack on a city, with certain of the most lethal classical agents We must also prepare for rapid acquisition of necessary equipment and hospital bed space in an emergency Finally, we must consider and prepare for the potential psychological impact of a biological attack on our primed society.


6.        Physical countermeasures: Fewer physical countermeasure options exist for the civilian population than for the military force At present, technological hurdles (cost, logistical requirements, narrow spectrum and high false-positive rates) prevent the widespread application of sensor technologies for biological terrorism Without timely warning, protective masks seem to have little utility However, some experts advocate the development of a simple, inexpensive bio-only mask to be carried in automobile, briefcase or purse To date, this concept falls below the threshold set by the balance between perceived risk and benefit to the population Collective protection by modification of HVAC systems in critical public buildings may have utility Decontamination of patients, buildings and environmental areas must be considered It is believed that decontamination following a biological event is less important than following a chemical attack The true aerosol that is required for effective dissemination of a non-volatile biological agent might leave little residual, except around the area of detonation That agent which is deposited is thought to be poorly reaerosolized and subject to inactivation by environmental factors, especially ultra-violet light.

7.        Public health infrastructure: Strengthening our public health infrastructure should be at the forefront as we prepare for bioterrorism. Effective surveillance programs, improving the laboratory capabilities at state and local levels, teaching and practicing public health and epidemiology, enhanced communications and health threat response systems are all dual-use functions. Not only do they prepare us to better respond to a man-made outbreak but to a naturally occurring one as well The current initiative supported by the Public Health and Social Services Emergency Fund for FY2000 is an important start As with our biomedical tech base and intelligence programs for biodefense, we must think long-term in supporting our public health infrastructure It will be cost effective.

8.        Interagency collaboration: Preparing to respond to biological terrorism must involve intelligence, law enforcement and other traditional first responders, clinical and research medical communities, public health, political leadership and the military It must involve national, state, regional and local organizations, agencies and officials As the perceived threat has mounted and the federal government has responded with funds, bioterrorism defense has become a growth industry. Yet, no single office with the necessary authority has clearly taken the lead, either within the Department of Defense or the federal government Therefore, interagency collaboration has become even more important Vertical (local through national) and horizontal (across all disciplines) communication and willingness to collaborate are imperative Excellent leadership facilitates necessary collaboration.

9.        Educational programs: Education and training must be given the highest priority The fundamentals of what is needed in a hospital or medical center facing a spike in the patient load following an attack is application of the standard principles of medicine with which the professional and support staffs are already intimately familiar But our health-care providers have not seen the diseases caused by many of the threat agents Education and training must include the general characteristics of biological agents versus chemical agents; clinical presentation, diagnosis, prophylaxis and therapy of the most important diseases; sample handling, decontamination and barrier patient care Training, planning and drills must prepare physicians and staff for mass-casualty patient management, respiratory support for unusual numbers of patients, distribution of medications or support of the local government in vaccination programs Engineering staffs must be taught to establish improvised containment in patient rooms or suites. Traditional first-responders and public and military leaders must understand rather complex technical and biological issues in order to effectively balance cost and benefit in preparation and response. Application of the knowledge we already have though education may be the least expensive and the most important thing we can do as we prepare.

10.     Complementary programs: In addition to the obvious domestic preparedness initiatives needed, we must be prepared through the military or law enforcement to destroy biological weapons whether deployed or in storage We must have the means to neutralize facilities wherever they are found We must seek and support international law that would bring proliferators to justice. We must seek to enhance communication between scientists internationally, through cooperative threat reduction programs with states that might threaten us; there are significant risks inherent in these programs, but there are huge potential payoffs as well. 

11.     New Technologies: We must exploit to the fullest, the phenomenal advances in both biotechnologies and the cyber- and communication technologies that have occurred in parallel with the changing biological terrorist threat Genomics and proteomics are revolutionizing diagnostics, vaccine development and drug discovery These have obvious and wide application for biodefense. Telemedicine, robotics, virtual reality and simulation, nanotechnology and the Internet and wireless communications must be used to replace or augment human capabilities and allow us to respond more quickly when lives are threatened If we keep the pressure on those who would use these breakthroughs for evil---taking away their freedom through effective intelligence programs and law enforcement---we will be more likely to stay steps ahead as we use the technologies for good, and provide an additional deterrent to the threat.

Bioterrorism presents a daunting problem to our free society, especially at the unique intersection of politics and biotechnology that occurred during the last decade of the 20th century We may have been lulled by our prosperity and strategic isolation from major conflict into a sense of invulnerability. However, we are vulnerable today and there is no reason to believe that will change in the near future We must carefully evaluate the real threat, make the hard cost-benefit decisions and continue to build a fully integrated defense against the distortion of biology by those who would do us harm.