Within weeks after the September 11th terrorist attacks, the Centers for Disease Control and Prevention requested the Center for Law and the Public's Health at Johns Hopkins and Georgetown Universities to draft a model state "emergency health powers" law. After input from a variety of sources, including experts in relevant fields and members of the public, the Center for Law and the Public's Health released its most recent draft of "The Model State Emergency Health Powers Act" in December 2001. Currently, about two-thirds of the state legislatures are considering the Model Act in some form.

What the Model Act Does

The Model Act, which is divided into eight Articles, gives state officials a broad array of powers to detect and contain a potentially catastrophic disease outbreak, whether from an intentional bioterrorism attack or from natural causes. These powers range from pre-emergency planning to compensation for private property affected by the emergency, and include the tracking and reporting of certain diseases, the management of property, and the protection of persons. The Act was drafted to balance the power of the state to protect the public's health with the liberties of the individual in a free society.

Most public health laws are enacted under state police powers and, consequently, vary among the states. Therefore, the Model Act is just that - a "model" for states to consider when reviewing their own laws. Some states may review their laws and determine that they should enact the Model Act virtually as is. Other states may be satisfied with their current laws. Still others may pass a version of the Model Act but make changes or additions to it.

Under the Act, a "public health emergency" is defined as "an occurrence or imminent threat of an illness or health condition that" must satisfy two conditions. First, the illness or health condition must be believed to have been caused by either: (i) bioterrorism or (ii) the appearance of a novel or previously controlled or eradicated infectious agent or biological toxin. Second, the illness or health condition must also pose a high probability of any of the following harms: (i) a large number of deaths in the affected population; (ii) a large number of serious or long-term disabilities in the affected population; or (iii) widespread exposure to an infectious or toxic agent that poses a significant risk of substantial future harm to a large number of people in the affected population. In order to further define a "public health emergency," a state might add a third requirement that it also "significantly threatens to impair the normal functioning, stability or security of the state or region affected."

Perhaps the single most important aspect of the Model Act to consider in the near future is Article II, which provides for the establishment of - and authorizes a Governor to appoint members to - a Public Health Emergency Planning Commission. The Commission must deliver to the Governor a plan for responding to a public health emergency as defined in the Act within six months of its appointment, and review the plan each year. Among the types of planning required under Article II are the development of safe treatment and vaccination guidelines; the identification of sites where medical supplies, food and other essentials can be distributed; and the assurance that the judiciary will continue to function during the emergency to review public health decision-making.

Both the Dark Winter and TOPOFF exercises demonstrate that a potentially catastrophic bioterrorism attack or disease outbreak will require a well-coordinated response from all levels of government and the private sector. In addition, public cooperation will be essential and will only occur if the public is adequately informed and believes that government officials are making knowledgeable and fair decisions. A comprehensive and up-to-date plan as envisioned under the Act will help foster an effective response and the type of cooperation and communication that will be required.

While the Model Act provides many and sometimes far reaching powers to state officials, it does not mean that the use of each and every power will be necessary in any particular emergency. Indeed, powers such as quarantine and isolation are only justified under the Act in very limited circumstances. It is far more likely, therefore, that only some of the powers will be required during any one emergency. The decision to use any one power will depend upon the particular threat faced at the time and must be based on sound public health data and principles.

The alternatives to a comprehensive law of this sort are not nearly as appealing. States may, for example, have assortments of ad hoc powers located in various codes sections, which may be incomplete in coverage and difficult to pull together quickly. The Governor, too, may have more general emergency powers but with no clearly articulated restraints or guidance to address the peculiar issues arising from a biological emergency.

Thus, far from providing unfettered power to the state, an emergency health powers law like the Model State Emergency Health Powers Act provides a clear, comprehensible framework under which state power may be executed.

What the Model Act Does Not Do

While the Model Act sets forth powers state officials may need during a public health emergency, the limits of those powers, and what triggers and terminates them, the Act does not and cannot legislate exactly how and to what extent those powers should be executed.

For example, the Act permits the quarantining of individuals and groups under specified conditions. Among other things, quarantine must be by the least restrictive means necessary to prevent the spread of a contagious or possibly contagious disease to others. Whether an individual is confined to his or her home or some other place is a decision necessarily left to the discretion of the public health and medical professionals.

The Act also allows public health officials to vaccinate individuals during the emergency. Vaccination is not compulsory, however, and someone may choose not to be vaccinated for reasons of health, religion, or conscience. Public health and medical professionals must decide whether those choosing not to be vaccinated should be isolated or quarantined to prevent the spread of a contagious or possibly contagious disease.

Similarly, the Model Act empowers the Governor to activate the state's national guard, which may include police officers, firefighters, and other emergency personnel. The Governor must still decide whether activating the guard will otherwise jeopardize public safety if these important personnel are diverted from their regular duties.

Additionally, the Model Act was never intended to address all the issues that have been identified which might undermine an effective response to the type of public health emergency contemplated here. For example, most hospitals and emergency departments currently do not have adequate surge capacity to deal with a minor, much less a major, influx of patients.

Addressing the shortcomings of the public health infrastructure is beyond the scope of the Act even though resolution of this problem is just as critical to an effective response. A comprehensive law of this sort is a crucial component of a much larger response, or in public health terms, it is "necessary but not sufficient."

Conclusion

As expected, the Model Act has generated lively debate because it addresses individual, local, state, national, and even international interests of great concern. One valuable lesson learned from the September 11th attacks and the subsequent anthrax mailings is that the American public and its institutions are more than willing to contribute and make sacrifices when called upon during a national crisis. The Model State Emergency Health Powers Act is designed to help make those contributions and sacrifices most effective and fair to all.

Editorial note: The Johns Hopkins Center for Civilian Biodefense Strategies gratefully acknowledges the authors of this article, who are affiliated with The Center for Law and the Public's Health at Johns Hopkins and Georgetown Universities: Julie Samia Mair, Jason Sapsin, Stephen Teret.

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Editorial note: Readers are encouraged to review the full consensus statement of the Johns Hopkins Working Group on Civilian Biodefense, published in the May 8, 2020 issue of The Journal of the American Medical Association, Volume 287, No. 18.

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The anthrax attacks of autumn 2001 illustrated that the United States lacks the public health capacity to adequately manage even a relatively small-scale bioterrorist event. The attacks also revealed a deficit in both scientific knowledge about bioterrorist agents and medical countermeasures against these pathogens. President Bush's proposed fiscal year (FY) 2003 budget indicates that the Administration recognizes the critical need for a significant investment in biodefense R&D to address these gaps.

An analysis of the proposed FY2003 budget by the American Association for the Advancement of Science found that the Department of Defense (DOD) and the National Institutes of Health (NIH) receive the vast majority of the biodefense R&D funds. In the DOD, the Chemical and Biological Defense Program gets a 70% boost to $933 million, which is more than double the FY2001 appropriation. Interestingly, the funding allocated for the Defense Advanced Research Projects Agency's (DARPA) Biological Warfare Defense program is cut by nearly 10%, from $147 million in FY2002 to $133 million in FY2003 (however, the funding levels are being raised for most of DARPA's other research areas).

The largest biodefense R&D increases occur at the NIH, specifically at the National Institute of Allergy and Infectious Diseases (NIAID), which will receive an unprecedented $1.7 billion for biodefense research and for construction of high-containment laboratory facilities. This is a dramatic increase from the FY2002 and FY2001 funding levels, which were $275 million and $50 million, respectively.

NIH, traditionally, has been a funder of basic research. However, in the biodefense arena, it is committed not only to funding fundamental research, but also to promoting the translation of basic research into new products (therapeutics, diagnostics, vaccines, etc.).

In order to manage this challenging task, NIAID convened a panel of distinguished researchers and medical experts to help the NIAID leadership formulate an immediate research strategy to address the threats posed by the biological agents of greatest concern (as identified in the Centers for Disease Control and Prevention's Category A list of agents): anthrax, smallpox, plague, botulism, tularemia, and viral hemorrhagic fevers. This report was published in February 2002.

NIH has also published a list of research concepts that are designed to form the foundation of a broader-based biodefense R&D initiative.

As we move forward, there are a number of critical issues that must be addressed to ensure that the investments in biodefense R&D will deliver. The nation, not just NIAID, needs to have a clear R&D strategy that will structure our investments so that we get the products that we truly need. We must find new and innovative mechanisms to engage the full power of the biomedical research establishment - in government, academia, and industry. Unlike much of the traditional defense industries, the biotech and pharmaceutical sectors don't need government contracts to survive. Yet their expertise in the development and production of pharmaceuticals is a necessary component of an effective biodefense initiative; therefore, creative ways to engage industry are essential.

Finally, investments in biodefense must be long-term. A few spectacular years of funding will not prompt academic or industrial researchers to redirect their efforts toward biodefense. Biomedical research and product development takes years, sometimes decades, before it bears fruit. In order to achieve progress, the U.S. government must be willing to make a long-term financial commitment to biodefense R&D.

The benefits of this kind of investment are certain to spill over into our ability to fight infectious disease generally. This could even result in the elimination of epidemics (intentional or natural) worldwide, which would truly be the ultimate biodefense.

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The future depicted in Huxley's Brave New World isn't frightening because it is grim, oppressive, or painful; it is frightening because the people in that world are utterly, completely, content. Thanks to amazing advances in genetic engineering and psychotropic drugs, the novel's characters no longer feel pain or isolation, and their lives are centered on pleasure. Yet the characters are somehow alien to us, precisely because of their lack of pain, struggles and their independence from a biological family. In a brave new world, human nature itself has been altered beyond our recognition.

In Our Posthuman Future: Consequences of the Biotechnology Revolution, Francis Fukuyama argues that "Huxley was right, that the most significant threat posed by contemporary biotechnology is the possibility that it will alter human nature and thereby move us into a 'posthuman' stage of history." This post-human stage could look like Huxley's brave new world, or it could result in another type of social disorder.

How are we on the path to the alteration of human nature? Fukuyama points to the increasing powers of biology to explain behavior, the development of new drugs like Prozac that manipulate emotions, the prolongation of life without regard to the quality of life, and finally, the germ-cell (inheritable) changes possible with genetic engineering.

While Fukuyama lauds the benefits possible with biotechnology, he cautions against the subtle degradation of what it means to be human. Fukuyama describes human nature as "the sum of the behavior and characteristics that are typical of the human species, arising from genetic rather than environmental factors." This inheritable combination of traits gives us a common ground whether we are from New Jersey or New Delhi, and whether we are from the 21st century or the 5th.

It is this stable common ground that humans have with each other that is the basis for our political rights in this country, that we are "created equal." Should genetic alterations be permitted - babies made smarter, or the introduction of genes from another species - everyone will not be created equal, or, arguably, human. By altering human nature, one is therefore tampering with the political order, with possible consequences such as a genetic hierarchy.

What then, should people do about biotechnology? Fukuyama unequivocally states "We should use the power of the state to regulate it." Institutions need to be created to distinguish between the good and bad uses of biotechnology, to safeguard the advances that biotechnology can bring but without the threat to human nature and human dignity. While these institutions need to be built on a national level, they must eventually be expanded to have international control.

While Fukuyama believes at least one biotechnology - human cloning - should be banned outright, his views generally lie somewhere between the groups who want to ban biotechnology altogether and those who want a completely laissez-faire approach.

He believes that self-regulation, which worked well in the past for biotechnology, may no longer be possible because of the huge infusions of cash and commercial interests into the field. To those who would say that scientific inquiry is a "right," Fukuyama argues that science should be done in, and for, the public interest. It is only "theology, philosophy, or politics" which can establish whether the ends to which science is put are good or bad. Though Fukuyama does not deal with bioterrorism in this book, he mentions it as one more reason why science should be controlled.

About ten years ago, Francis Fukuyama famously claimed that there was "an end of history," heralding a "convergence toward liberal democracy around the globe." Critics of his theory argued that there cannot be an end of history until there was an end of science, for science has been one of the drivers of change in human affairs. In "Our Posthuman Future," Fukuyama maintains that humans are at the end of their history, but if we don't control science for the public interest, nothing less than human nature is under the gun.

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As bacteriologist and historian Hans Zinsser wrote in 1934, "However secure and well-regulated civilized life may become, bacteria, Protozoa, viruses, infected fleas, lice, ticks, mosquitoes, and bedbugs will always lurk in the shadows ready to pounce when neglect, poverty, famine, or war lets down the defenses. And even in normal times they prey on the weak, the very young and the very old, living along with us, in mysterious obscurity waiting for opportunities." This quote, excerpted from the first chapter of Secret Agents, foreshadows what is to follow.

Ms. Drexler provides a description of bacteria and viruses suitable for the lay audience, while being provocative, honest, and forward-looking in her views on disease and public health. She outlines how damage is inflicted by these microorganisms, and how today's technologies allow them to travel anywhere in the world within 48 hours.

Drexler asserts that "...the distinction between national and global threats is artificial. Infectious agents need no visas. Secret agents shadow ecological change everywhere, and the pace of change is speeding up." She envisions public health surveillance and response as solutions to preparing for biological events that are inevitable, yet unpredictable. Nevertheless, she acknowledges that only long-range planning and long-term funding can sustain such a global undertaking.

If we are puzzled about where emerging infections come from and how they gain a foothold, declares Drexler, we need only a glimpse at our own lives. Virtually every aspect of American culture - from where we live to where we play, from how we raise livestock to how we raise our children - is changing. Change creates new markets...for pathogens. And these agents have a knack for leveraging the slimmest advantage, she concludes. The irony is that "Modern technologies intended to make our lives easier may also make life easier for microbes."

The chapter entitled "Bioterror" provides a good overview of the recent anthrax cases. It also identifies other potential biowarfare agents, provides specific symptoms, and includes the very real danger of genetically engineered pathogens.

Drexler also describes the ease with which aspiring criminals can gain access to bioweapons knowledge, using resources as benign as the "methods" section of a scientific journal article, which she maintains is a "gold mine for potential terrorists."

To conclude this section, she discusses what the public health system can do to be more prepared, and touches on some fascinating research already being done by the Pentagon's Defense Advanced Research Projects Agency (DARPA). Nevertheless, she insists that "while treaties and negotiations are underway to prevent an attack, the defense for either a natural or intentional epidemic is the same: a robust global public health surveillance system, internationally financed and managed." Drexler ultimately believes that the answers lie in keen surveillance and rapid response and concludes by encouraging the reader to "Think Locally, Act Globally."

During the Great Depression, Hans Zinsser wrote that "Infectious disease is one of the few genuine adventures left in the world." Drexler points out that "Modern adventurers like to up the ante, but even the most extreme sports wouldn't produce the adrenaline of a race against pandemic influenza or a cloud of anthrax at the Super Bowl. In the field of infectious disease, reality is stranger than anything a writer could dream up. The most menacing bioterrorist is Mother Nature herself."

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The Office of Homeland Security. Keep up to date on the latest happenings at the Office of Homeland Security including events, news, budget information as well as information on state homeland security efforts.

Project on Congress and Nonproliferation. New from the Monterey Institute for International Studies Center for Nonproliferation Studies, this site provides timely information regarding the events, legislation, and people essential to the Unites States Congress' efforts to reduce the threat of weapons of mass destruction including links to relevant legislation and hearings.

Lawrence Berkeley National Laboratory Indoor Environment Department. Offers current advice for dealing with a small or medium-sized biological or chemical release within a building (such as those that would be expected from a terrorist attack).

USAMRIID's Medical Management Of Biological Casualties Handbook (Blue Book). The 4th edition of the 'Blue Book' from the United States Army Medical Research Institute of Infectious Diseases is available online. Provides in depth information on biological weapon agent characteristics, therapeutics, diagnostics and much more. Also provides a Palm OS version for download.

Joint Program Office for Biological Defense. Contains information on the Department of Defenses' programs to develop, test and acquire automated biological detection systems, medical diagnostics and countermeasures for the U.S Armed Forces including a link to the Joint Vaccine Acquisition Program (JVAP).

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Annas G. 2002. Bioterrorism, public health and civil liberties. The New England Journal of Medicine. Apr 25; 346(17). Critiques the Model State Emergency Health Powers Act.

Benjamin GC. 2002. Managing terror. Public health officials learn lessons from bioterrorism attacks. Physician Executive. Mar-Apr;28(2). Reviews what was learned and how we can better prepare for future attacks.

Borio L, et al. 2002. Viral hemorrhagic fevers as biological weapons: Medical and public health management JAMA. May 8. Provides consensus recommendations of the Working Group on Civilian Biodefense on detection, diagnosis, prophylaxis and treatment of several hemorrhagic diseases.

Bremen J, Henderson DA. 2002. Diagnosis and management of smallpox. The New England Journal of Medicine. Apr 25; 346(17). Provides an overview of smallpox - a disease which few physicians have ever seen.

Brookmeyer R, Blades N. 2002. Prevention of inhalational anthrax in the U.S. outbreak. Science. Mar 8;295(5561). Chronicles the epidemiology of the October 2002 anthrax outbreak.

Frey SE, et al. 2002. Clinical responses to undiluted and diluted smallpox vaccine. The New England Journal of Medicine. Apr 25;346(17). Outlines that when given by a bifurcated needle, vaccinia virus vaccine can be diluted to a titer as low as 107.0 pfu per milliliter (approximately 10,000 pfu per dose) and induce local viral replication and vesicle formation in more than 97 percent of persons.

Frey SE, et al. 2002. Dose-related effects of smallpox vaccine. The New England Journal of Medicine. Apr 25;46(17). Concludes that the vaccinia virus vaccine (which was produced in 1982 or earlier) still has substantial potency when administered by a bifurcated needle to previously unvaccinated adults.

Fukuyama F. 2002. Gene regime. Foreign Policy. March/April. Raises questions about what should be done to settle the troubling concerns over biotechnology.

Goldenberg A, Shmueli G, Caruana RA, Fienberg SE. 2002. Early statistical detection of anthrax outbreaks by tracking over-the-counter medication sales. Proceedings of the National Academy of Sciences of the United States of America. Apr 16;99(8). Describes a statistical framework for monitoring grocery data to detect a large-scale but localized bioterrorism attack. Also proposes an evaluation methodology that is suitable in the absence of data on large-scale bioterrorist attacks and disease outbreaks.

Inglesby T, et al. 2002. 2002 Update: Anthrax as a biological weapon: Medical and public health management. JAMA. May 1. Using the October 2001 anthrax attacks as a basis for research, the article provides updated consensus recommendations of the Working Group on Civilian Biodefense on detection, diagnosis, prophylaxis and treatment of anthrax.

Landers S. 2002. Infection control reminders still necessary. AMNews. Mar 18. Provides practical information on preventing spread of disease.

O'Toole T, Mair M, Inglesby, TV. 2002. Shining light on dark winter. Clinical Infectious Diseases. Apr. Vol 34. Provides overview of the Dark Winter exercise and cites lessons derived from the simulation.

Patt HA, Feigin RD. 2002. Diagnosis and management of suspected cases of bioterrorism: A pediatric perspective. Pediatrics. Apr;109(4). Provides specific and detailed diagnostic, treatment, and prophylaxis information for anthrax, plague, tularemia, smallpox, botulism, viral hemorrhagic fevers, and other diseases, as well as information regarding emergency contacts and links to educational resources.

Ramirez JC, Tapia E, Esteban M. 2002. Administration to mice of a monoclonal antibody that neutralizes the intracellular mature virus form of vaccinia virus limits virus replication efficiently under prophylactic and therapeutic conditions. Journal of General Virology. May;83(Pt 5). Study reinforces the notion that neutralizing mAbs should be developed to control health-related human infections by poxviruses.

Sacra JC, Murphy M. 2002. Oklahoma City and Tulsa Metropolitan Medical Response System. Journal of the Oklahoma State Medical Association. Apr;95(4). Describes how coordinated planning between two cities brings added benefits.

Salyers A. 2002. Science, Censorship and the Public Health. Science. Apr 26; 296(5568). Argues that professional scrutiny afforded through the publication of scientific results reduces the likelihood that science is used for malevolent ends.

Simpson RL. 2002. Our first line of defense against bioterrorism. Part 1. Nursing Management. 2002 Mar;33(3). Highlights the need to enlist information technology tools in the defense against bioterrorism. Part 1 of a two-part series explains what went wrong in the most recent attack and suggests how a national IT infrastructure might help in the future.

Sobel J, Khan AS, Swerdlow DL. 2002. Threat of a biological terrorist attack on the US food supply: the CDC perspective. Lancet. Mar 9;359(9309). Outlines vulnerabilities in the US food supply and measures necessary to prepare for a terrorist incident.

Strauss M. 2002. Why attacking Iraq should not be phase two of the global war on terrorism. Foreign Policy. March/April. Argues that just because Saddam Hussein backs anti-U.S. terrorists, has a nasty arsenal that weapons inspectors won't find, and isn't essential to the survival of a unified Iraq, doesn't mean that Iraq should necessarily be "phase two" in the war against terrorism.

Szabo J. 2002. Federal funds begin flowing to states for public health improvements. Medical Laboratory Observer. Mar;34(3).

Voelker R. 2002. Medical educators weigh curriculum changes to address threats of terrorism. JAMA. 287(9). Outlines long-term challenges faced by medical schools and teaching hospitals in changing curriculum to address potential terrorist scenarios.

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