Tara O'Toole

Smallpox Vaccination: A Review, Part II. Adverse Events

Smallpox vaccination of health care workers, military personnel, and some first responders has begun in the United States in 2002-2003 as one aspect of biopreparedness. Full understanding of the spectrum of adverse events and of their cause, frequency, identification, prevention, and treatment is imperative. This article describes known and suspected adverse events occurring after smallpox vaccination.

Confronting the risks of terrorism: making the right decisions ☆ ☆☆

Abstract This report offers a methodology for assessing, quantitatively, the risks of terrorism. The purpose of the methodology is to support effective decision making to combat terrorism. The emphasis is on terrorist attacks that could have catastrophic consequences. The perspective taken is that in order to make the right decisions about combating terrorism, their needs to be a systematic means of assessing the likelihood of such attacks. A process of implementation of the decisions resulting from risk assessment is essential. That process includes (1) an understanding of the nature of the threat, (2) an information system linked directly to ‘intelligence’ on terrorism, and (3) organizational structures that can take timely, coordinated, and effective actions. There must also be sound evidence that the methodology can be successfully applied. A description of the nature of terrorism, a terrorism risk assessment methodology, information requirements to fight terrorism, and recommendations for successful implementation is what this report is about.

Smallpox Vaccination: A Review, Part I. Background, Vaccination Technique, Normal Vaccination and Revaccination, and Expected Normal Reactions

Because smallpox could be a factor in bioterrorism, the United States has provided guidelines for smallpox vaccination of certain members of the population, including health care workers and first responders, as well as military personnel. A plan for more extensive vaccination, if it is needed in the event of a bioterrorist attack, is being developed under the aegis of the Centers for Disease Control and Prevention. The characteristics of smallpox vaccine, the technique of administration, and the expected reactions to primary vaccination and revaccination are outlined in this article.

Anthrax 2001: observations on the medical and public health response.

THIS ARTICLE DESCRIBES ASPECTS of the medical and public health response to the 2001 anthrax attacks based on interviews with individuals who were directly involved in the response. It has been more than 18 months since B. anthracis spores were discovered in letters sent through the U.S. postal system. The specific purpose and perpetrator(s) of these attacks remain unknown. A total of 22 people developed anthrax as a result of the mailings, 11 suffered from the inhalational form of the disease, and 5 of these people died. Thousands of workers—including health care, public health, environmental, and law enforcement professionals—participated in the response to the attacks. Thousands more were directly affected, including individuals working in facilities contaminated by the attacks and their families. The immediate and continuing medical and public health response to the anthrax attacks of 2001 represents a singular episode in the history of public health. After-action assessments of the response to the anthrax attacks could offer invaluable opportunities to better understand and remedy the systemic vulnerabilities revealed by America’s only experience with an anthrax attack. Yet there still has been no comprehensive published analysis of the response to these events. In December 2001, the Center for Strategic International Studies convened a meeting, which included high-level government officials directly involved in managing the crisis, to discuss the response and review lessons learned. The report describing this meeting has been withheld from public distribution by the Department of Defense, which supported the meeting, on the grounds that the document contains sensitive information.1 The “response” to the anthrax attacks was extremely complex, and any analysis that purports to assess the response must account for this complexity. The unprecedented nature of the attacks and the context in which the response occurred are also crucial to understanding what happened and why. The long-standing neglect of federal, state, and local public health agencies, and the highly stressed condition of U.S. medical facilities, which routinely work at the limits of their capacity, are acknowledged by virtually all informed observers. That the medical and public health institutions involved in the response functioned as well as they did is a tribute to the extraordinary efforts of the individuals involved. Despite the commitment and hard work of the individuals in these professional communities, what was revealed by the anthrax attacks was an unacceptable level of fragility in systems now properly recognized as vital to national defense. Too many citizens, elected leaders, and national security officials still have limited understanding of the degree to which 22 cases of anthrax rocked the public health agencies and hospitals involved in the response to this small bioterrorist attack. Most of the vulnerabilities in the medical and public health systems revealed by the response remain unaddressed. It is not the purpose of this article to praise or criticize individuals who responded to the 2001 anthrax attack. The emphasis here is on how to improve response systems. The article seeks to identify the strategic and organizational successes and shortcomings of the health response to the anthrax attacks so that medical and public health communities as well as elected officials can learn from this crisis. The recent international spread of Severe Acute Respiratory Syndrome (SARS) is illustrating once more the importance of effective public health response systems. Initial impressions of the Centers for Disease Control and Prevention’s response to SARS indicate that the agency has improved several aspects of epidemic response that were problematic in the aftermath of the 2001 anthrax at-

Preventing the Use of Biological Weapons: Improving Response Should Prevention Fail

This article presents an overview of the nature and scope of the challenges posed by biological weapons, and offers ways by which the infectious diseases professional community might address the challenges of biological weapons and bioterrorism.

Biosecurity: Responsible Stewardship of Bioscience in an Age of Catastrophic Terrorism

BIOLOGICAL RESEARCH has undergone tremendous growth and transformation since 1876, when Robert Koch identified Bacillus anthracis as the causative agent of anthrax, since the structure of DNA was solved in 1953, and even since a “rough draft” of the human genome was completed in February 2001. This expansion of knowledge and the powers it brings shows no signs of slowing, and will undoubtedly bring vast benefits in diagnosing, preventing, and curing disease, and in improving agriculture. However, a plentiful array of the same tools, techniques, and knowledge that have beneficent uses could, if misapplied, be used to destroy human life or agriculture on a mass scale. While it is not a new phenomenon that technologies can have positive and negative consequences, biological science is unique in that its powers over both life and death are profound, and the culture of bioscience is open and relatively available, particularly when compared to nuclear weapons research. In the aftermath of the anthrax attacks of 2001 and the terrorist assaults on the World Trade Towers, policymakers awakened to these inherent powers of biological research and began calling for more governmental controls. The Patriot Act (2001)1 and the Public Health Security and Bioterrorism Preparedness and Response Act of 20022 imposed new regulations on the conduct of research involving “select agents”—the several dozen pathogens that the Centers for Disease Control and Prevention judges to be the most dangerous potential biological weapons. In recent months, the White House Office of Science and Technology Policy has met with representatives of professional science societies, private industry, and others to discuss restricting access to “sensitive homeland security information” generated within government agencies, possibly including data published in scientific journals, lest advances in knowledge and technology inadvertently fuel terrorist attacks using biological weapons. As debate proceeds about whether or how to more closely govern the practice of biological research, it is critical that the profound stakes are understood for both national security and bioscience: a broad scope of research in the life sciences could conceivably be applied towards biological weapons development, but this same research will be essential to creating the medicines, vaccines, and technologies needed to counter the threat of bioterrorism and naturally occurring disease. Efforts to monitor comprehensively all bioscience research that has potentially destructive applications would subsume huge swaths of science, gravely tax civilian research resources, and could discourage scientists from pursuing advances in fields important to medicine and agriculture, fields we urgently need to advance in order to address the grave vulnerabilities currently imposed by bioweapons. The problem of biosecurity in an age of bioterrorism is how to constrain malignant applications of powerful bioscience responsibly without damaging the generation of essential knowledge. Over time, we must construct a network of “checks and balances”: regulations, incentives, cultural expectations and practices that encourage and enable progress in scientific understanding so that knowledge can be brought to bear on human needs, while simultaneously assuring responsible stewardship of powerful knowledge so that it is not used for malevolent purposes. Such stewardship will have to evolve— rapidly, in concert with the pace of advances in the life sciences—to embrace a network of international agreements, legal regulations, professional standards, ethical mores, and catalogues of “best practices” pertinent to

Emerging illness and bioterrorism: Implications for public health

Biological weapons have the potential to inflict deliberate, potentially devastating epidemics of infectious disease on populations. The science and technology exist to create deliberate outbreaks of human disease, as well as disease among plants and animals, crops, and livestock. A new awareness among policymakers of the link between public health and national security requires the attention of public health professionals. The issues posed by biological weapons are likely to challenge the political assumptions of many progressive public health professionals and will demand new coalitions. The prospect of bioterrorism may offer new opportunities for improving the public health infrastructure and its capabilities.

Biodefense R&D: Anticipating Future Threats, Establishing a Strategic Environment

DEFENSE STRATEGY should be to eliminate the possibility of massively lethal bioterrorist attacks. A central pillar of this strategy must be an ambitious and aggressive scientific research, development, and production (R&D&P) program that delivers the diagnostic technologies, medicines, and vaccines needed to counter the range of bioweapons agents that might be used against the nation. A successful biodefense strategy must take account of the rapidly expanding spectrum of bioweapons agents and means of delivery made possible by 21st century advances in bioscientific knowledge and biotechnology. Meeting this challenge will require the engagement of America’s extraordinary scientific talent and investments of financial and political capital on a scale far beyond that now committed or contemplated. The purpose of this article is to provide a brief analysis of the current biomedical R&D&P environment and to offer recommendations for the establishment of a national biodefense strategy that could significantly diminish the suffering and loss that would accompany bioterrorist attacks. In the longer term, a robust biodefense R&D&P effort, if coupled to substantial improvements in medical and public health systems, could conceivably render biological weapons ineffective as agents of mass lethality.