ELIN GURSKY ET AL., ANTHRAX 2001: OBSERVATIONS ON THE MEDICAL AND PUBLIC HEALTH RESPONSE
Biosecurity & Bioterrorism 97 (2003).
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 . . .
The “response” to the anthrax attacks [which infected 22 people and killed 5] 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 this 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….
Chronology of Key Events Following the Attacks
October 2, 2001—An infectious disease physician recognized a possible case of inhalational anthrax in a man hospitalized in Palm Beach County, Florida. This physician contacted the local health officer in Palm Beach County, who immediately began a public health investigation. By October 2, there were already 7 persons with cutaneous anthrax in the northeastern U.S., but none had yet been diagnosed.
October 4—The microbiologic diagnosis of B. anthracis was confirmed by the Florida Department of Health (FDH) and the Centers for Disease Control and Prevention (CDC), and the diagnosis was made public. Epidemiologic and environmental investigations were launched to determine the source of the patient’s anthrax exposure. Evidence of contamination with B. anthracis was found at American Media Inc. (AMI) in Boca Raton, Florida where the first victim worked as a photo editor.
October 5—The first victim of the anthrax attacks died. A second AMI employee, who had been hospitalized for pneumonia on September 30, was diagnosed with inhalational anthrax. He was an employee in the AMI mailroom.
October 6—The Palm Beach County Health Department began to obtain nasal swabs from those who had been in the AMI building in an attempt to define exposure groups. Because nasal swab testing was known to be an insensitive diagnostic test, the health department also recommended prophylactic antibiotics for all those people who had been in the AMI building for at least one hour since August 1 regardless of the results of their nasal swab tests. Environmental samples taken from the mailroom showed evidence of B. anthracis.
October 7—A nasal swab was positive on another employee. A swab from the first victim’s computer screen was positive. The AMI building was closed.
October 9—The New York City Department of Health notified CDC of a woman with a skin lesion consistent with cutaneous anthrax. The woman, an assistant to NBC anchor Tom Brokaw, had handled a powder-containing letter postmarked September 18 at her workplace.
October 13—Another cutaneous case of anthrax was recognized in a 7-month-old infant who had visited his mother’s workplace, the ABC office building on West 66th Street in Manhattan, on September 28.
October 13—Symptoms of cutaneous and inhalational anthrax in New Jersey postal workers began to be observed and reported by physicians to the New York City Health Department. Diagnoses of anthrax are confirmed by the CDC on October 18 and 19.
October 15—A staff member in the office of Senator Daschle in the Hart Senate Office Building opened a letter (postmarked October 9) which contained a powder and a note identifying the powder as anthrax. The powder tested positive for B. anthracis on October 16. Nasal swab testing of anthrax spores was performed on 340 Senate staff members and visitors to the building who potentially were exposed and to approximately 5,000 other people who self-referred for testing. This testing indicated exposure in 28 persons. Antimicrobial prophylaxis was administered on a broader scale and environmental testing was initiated.
October 19—CDC linked the four confirmed cases of anthrax to “intentional delivery of B. anthracis spores through mailed letters or packages.”
October 19-22—Four postal workers at the Brentwood Mail Processing and Distribution Center in the District of Columbia were hospitalized with inhalational anthrax. The Brentwood facility was closed on October 21. On October 22 two of these four postal workers died.
October 24—CDC sent an advisory to state health officials via the Health Alert Network recommending antibiotic prophylaxis to prevent anthrax for all people who had been in the non-public mail operations area at the U.S. Postal Service’s Brentwood Road Postal Distribution Center or who had worked in the non-public mail operations areas at postal facilities that had received mail directly from the Brentwood facility since October 11.
October 27—A CDC alert recommended antibiotic prophylaxis for workers in the mail facilities that supplied the CIA, the House office buildings, the Supreme Court, Walter Reed Army Institute of Research, the White House, and the Southwest Postal Station after preliminary environmental sampling revealed B. anthracis contamination in these mailrooms.
October 31—A 61-year-old female hospital stockroom worker in New York City died from inhalational anthrax after she had become ill with malaise and myalgias on October 25. The source of her exposure remains unknown despite extensive epidemiologic investigation.
November 16—A 94-year-old woman residing in Oxford, Connecticut, was hospitalized with fever, cough, and weakness. She died on November 19. Her diagnosis was confirmed as B. anthracis on November 20 by the Connecticut Department of Public Health Laboratory. Subsequent environmental and epidemiological testing indicated exposure from cross-contaminated letters.
Public health decision-making processes The 2001 anthrax attacks challenged traditional decision-making processes of federal, state, and local public health authorities. Historically, most outbreaks of naturally occurring disease are first recognized in a limited geographic region; laboratory and clinical methods for accurately diagnosing and treating cases of an unfamiliar illness (e.g., HIV/AIDS, Hanta virus, Legionnaire’s Disease) often evolve over a period of months or even years. Data pertaining to the outbreak and the causes of the illness are collected and analyzed by scientists at CDC and other public health agencies and medical institutions, and these analyses are discussed in the academic public health and medical communities at conferences and in medical journals. With time, a consensus view usually emerges about the causes of a disease, who is at risk, and how the illness can best be diagnosed, treated, and prevented. These scientifically based guidelines often are published by CDC and/or professional medical societies and serve as the basis for state and local public health practice.
In October 2001, at the time of the initial discovery of a person with anthrax infection in Florida, public health officials worked closely with clinicians in Palm Beach County to rapidly confirm the medical diagnosis of anthrax and to initiate the epidemiologic investigation that followed. For many of the decisions and actions that would follow, traditional public health decision-making processes were not adequate to cope with the extent, pace, and complexities of events surrounding the attacks.
This was the first time that CDC had been called on to respond to outbreaks of illness occurring nearly simultaneously in five geographic epicenters. Because sending B. anthracis spores through the mail was clearly an act of terrorism, the FBI was involved, substantially increasing the number of people and organizations that needed to receive and interpret information pertinent to the disease investigation and remain “in the loop.” In addition, because anthrax is virtually unknown in current medical practice, few local or federal public health officials had ever seen or been involved in evaluating a single case of B. anthracis infection, let alone a bioterrorist attack resulting in a series of cases.
Many public health policies—for example, whether to offer needle exchange programs to stem the spread of HIV/AIDS, or the nature and extent of prenatal care programs—routinely differ quite extensively from state to state and reflect variations in resources, expertise, and judgments about local priorities and needs. In the context of the anthrax attacks, however, policies and recommendations that differed between states, and between states and CDC, caused confusion. In some case, inconsistencies in the response were interpreted as evidence of incompetence or inequitable treatment, rather than as nuanced reactions to local situations or principled disagreement about what was the best course of action.
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In some instances, state and local public health officials were reluctant to initiate public health actions, such as recommending prophylactic antibiotics, without benefit of specific CDC guidance. Other health departments made decisions prior to receiving CDC guidance, in some instances deciding to act in ways that conflicted with CDC recommendations. Such variations in states’ decisions were especially notable in the context of determining who was at risk for exposure to B. anthracis spores and who should receive prophylactic antibiotics.
Confusion and contention surrounded both CDC’s authority to mandate specific public health actions and state public health officials’ responsibility to act on their own best judgments. Noted one state public health official, “We relied on CDC as a consultant. They gave us guidance and knowledge, but we used our own instincts. [We concluded that], if the environment had one spore, you are exposed.” A local public health official expressed the view that although CDC’s scientific expertise was valuable, CDC was “a research-based organization, far removed from how public health is delivered,” and hence was not well placed to make operational decisions on the local level.
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On some occasions during the response to the anthrax attacks of 2001, confusion about who was at risk of developing anthrax and ambiguities about the extent of public health officials’ authority resulted in public health actions being influenced by political pressures. Several of those interviewed reported that in some locations elected officials had directed which groups of people should receive preventive antibiotics. In at least one case, differences among state health departments’ recommendations about who should receive antibiotic prophylaxis caused great concern among elected federal representatives. One public health official noted, “The media would compare our decisions to those made [elsewhere]. It was extremely uncomfortable. Elected officials came down on us regarding fairness. One elected official said, ‘The only fair thing was to give every postal worker [in the state] Cipro’ even though state public health officials believed that the information available warranted a more limited distribution of antibiotics.”…
In a number of areas targeted by the anthrax attacks, several different adjacent or overlapping public health agencies were simultaneously responding. City, county, and state health officials within states and across state borders, in many instances, had difficulty acquiring and sharing information and harmonizing their recommendation.
Medical and public health professionals from the greater Washington, DC, area reported many obstacles to reaching consensus decisions and to working collaboratively across the region. The Washington, DC, metropolitan area encompasses a complicated network of government jurisdictions. Many people who work in DC live in Maryland or Virginia. Three different health departments (Maryland, Virginia, and DC) were involved in the 2001 anthrax investigation and response. Although each was responsible for actions in their respective jurisdictions, the people at risk and the issues at stake often crossed geopolitical boundaries. In some instances, local public health officials working in these different jurisdictions were receiving contradictory recommendations from different sources….
CDC’s usual approach to investigating disease outbreaks—a careful, step-by-step gathering of evidence followed by deliberate scientific analysis—was not feasible in the context of a high-profile attack occurring in multiple epicenters that potentially placed thousands at risk and was causing massive disruption of government, business, and citizens’ routines. The analytical challenges were compounded by the complexities of the investigation. For example, the FBI was in charge of studying the anthrax powder found in the identified envelopes—material that immediately became evidence in a criminal investigation. It is unclear how soon CDC became aware that the anthrax powder found in the letter to Senator Daschle had different physical properties from the anthrax powder in letters sent to ABC, which had been examined earlier. The Daschle material was more refined, “fluffier,” and more likely to remain airborne, thus posing a greater threat of inhalation….
In the days immediately following the discovery of the first case of inhalational anthrax in Florida, CDC scientists had judged that only opened envelopes posed a risk of spore exposure. The investigation to date had revealed that no postal workers were ill in the Florida facility “upstream” of the contaminated letter that was believed to have been the source of the first victim’s exposure. Concerned about the potential side-effects of preventive antibiotics, and lacking information about what risks anthrax spores in sealed letters might pose to people working in the U.S. postal system, CDC initially recommended that only those in close proximity to opened anthrax-laden letters receive antibiotic prophylaxis. As the risks posed by sealed B. anthracis-laden envelopes became evident, prophylaxis recommendations were expanded to include mail handlers and others working in contaminated sites….
Postal workers also questioned the reliability of some of the CDC guidance. A representative of the postal workers noted, “The information [from CDC] changed every day. Nobody knew what was going on. I started a web page, but I would put something out and it would change. They said you need 10,000 spores to be ill, but we asked, ‘Can’t some people get sick with less?’ They said, ‘No. You have a better chance of getting hit by a bicycle.’ We had a party [to celebrate] the end of 60 days [of Cipro] and then they came back [a few weeks later] and said there were spores still living in us. They held a lot of meetings. I sat in on each one. Every doctor and every story was different. They said the stuff [vaccine] was safe but we would have to sign all these papers and maybe we could lose our rights under workers comp. Then they said the military people used to get six shots but we were going to get less. Even that doctor said she had the six. If six was good for her, why not for us?”
The confusion caused by these scientific uncertainties was compounded by the poor communication among public health officials and the media and the public. As the investigation first evolved and CDC learned more about the nature of the anthrax powder, the risk posed by unopened envelopes working their way through post office sorting machines, and other technical issues that bore on who was at risk and the nature of the public health response, the public heard little from top federal health officials. The lack of a consistent, credible message emanating from CDC in the early days after the anthrax attacks has yet to be fully explained.
CDC thus faced daunting challenges. The world expected CDC to provide detailed, authoritative information about a disease with which it was not familiar, in the context of a deliberate attack during a criminal investigation, the scope of which was larger than anything CDC had ever handled. Key aspects of the investigation were not under CDC’s control, and it is unclear to what extent CDC officials were free to speak to the public or the media.
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Faced with either poor access to public health officials or inadequate information, reporters scanned websites, downloaded articles, and attempted to identify experts. Without information from the public health authorities, one journalist noted that they had to assemble pieces of the anthrax puzzle from a variety of what they hoped would be credible sources. One reporter noted, “It was extremely difficult to get information [out of public health]. If I did not have a several-year relationship with officials, it would have been impossible. I have been in the business 25 years, but this was the fastest unfolding story. There was information, rumors, powders, and people on edge. It would have been useful to have a single person, point of contact, or continually updated website. Everyone was having meetings and things were hush-hush. They didn’t know what was safe to say. The press relied on back channel contacts. We wanted to make sure we did not embellish. This took effort. The job of good reporting is a function of the reliability of data. There were many agencies involved that had conflicting information. You don’t want reporters making scientific judgments.”
The anthrax attacks of 2001 placed heavy and novel demands on a public health system that long has been recognized to lack resources commensurate with its responsibilities. Although some public health officials reported that experience with previous communicable disease outbreaks had helped to prepare them to respond to the anthrax attacks, most believed that the demands placed on public health authorities by the anthrax crisis made this different from past public health events. One state public health official noted, “Public health planning for West Nile Virus, Y2K and even 9/11 facilitated the development of systems and strategies, but we were underprepared for the surge in demand [caused by the anthrax attacks].” A number of concerns were common across affected communities.
Communications technology was inadequate. Equipment widely requested on an emergency basis by public health officials during the attacks included computers, software applications, conference call capability, wireless email, broadcast fax, and cell phones….
Systems for emergency procurement of critical resources were lacking. Few public health departments had emergency procurement systems….
Public health laboratories were stretched. State public health laboratories across the country were highly stressed by the quantity of potentially contaminated items brought in for testing….
Notes and Questions
The authors of this study/description of the public health reaction to the anthrax letter attacks drew five conclusions: (1) Expectations about federal, state and local public health responsibilities require clarification; (2) Medical preparedness requires better communications among physicians and between medical and public health communities; (3) Public and medicine must recognize that response to bioterror attacks will evolve based on changing circumstances and new information; (4) Health officials must prepare to handle the media storm; and (5) Public health resources are barely adequate for a small-scale bioterror attack. Gursky, Inglesby & O’Toole supra, at 107-109. The report stressed the need for more funding for public health and noted that “The smallpox immunization plan announced by the administration in December 2002 [see infra] has added great stress to public health agencies around the country.” Id. at 109.
It is worth noting that this report identified no legal obstacles to public health response and recommended not changes in local, state, or federal law to enhance public health preparedness. Was this omission a mistake? Could specific legal changes have improved the quality of public health response to the anthrax mailings? If so, what changes would you recommend? Of course, the most critical pieces of information were scientific facts, such as how anthrax is spread. On the other hand, in an emergency, there will never be time to obtain all the scientific facts before acting.
The authors conclude:
It will take considerable vision and leadership—and sustained funding—to build the medical and public health systems needed to appreciably improve the nation’s capacity to mitigate the consequences of bioterrorist attacks. The anthrax attacks of 2001 demonstrated the feasibility of the use of biological weapons upon civilian populations. The SARS outbreak has again demonstrated the great responsibilities and challenges that the medical and public health systems bear in confronting disease epidemics, even when the overall number of cases remains relatively modest. Assessments of the response to the 2001 anthrax attacks and to other disease outbreaks such as SARS are critical to making wise decisions and strategic investments at the local, state, and federal levels concerning bioterrorism preparedness and response. Establishing the policy priorities, resources, and institutional capabilities to practice public health at a level of sophistication consistent with 21st century science and technology and commensurate with the threat posed by catastrophic bioterrorism is the task before us. Id. at 110.
Anthrax vaccine has been approved for use to prevent cutaneous anthrax and was mandatorily given to the troops in the Gulf War on the basis that it was an approved agent that could be given for an unapproved but closely-related use (inhalation anthrax). This vaccine was developed in 1970. After the Gulf War, DOD signed a sole source contract with a new company, Bioport, to produce anthrax vaccine. In 1998 Secretary of Defense William Cohen ordered that all active duty troops be given the anthrax vaccine, which was to be delivered in a series of six injections over an 18 month period. Some soldiers refused, and challenged the orders, arguing that the vaccine was experimental and thus could not be given without informed consent. Many of them were court-martialed. Anthrax vaccination was halted in 2001 when supplies ran out and the sole-source company was shut down by the FDA for failure to maintain proper manufacturing standards. Production and military vaccination resumed in 2002. There is no evidence of any military personnel or installation ever being attacked by anthrax anywhere in the world.
The bioterrorist anthrax attacks in the U.S. were on civilians, none of whom has been vaccinated. The recommended course of treatment for exposure to anthrax is 60 days of antibiotics, and antibiotics were made available to the 10,000 people potentially exposed. The anthrax vaccine was not available to civilians in October or November. In late December 2001, however, DOD agreed to supply sufficient vaccine to vaccinate the 10,000 exposed civilians. Of the 10,000 people eligible for the vaccine, only 152 eventually took it. Since the anthrax vaccine was an investigational drug when used for post-exposure inhalation anthrax, it could only be used in the context of a clinical trial, and then only with the informed consent of the subjects.
The FDA and CDC designed a consent form, together with a counseling process, for use in obtaining the consent of the exposed civilians to participate in the research project. Unlike the case of the military in the Gulf War, or even the peacetime military with the anthrax vaccine, in which the government required soldiers to be vaccinated, the choice was left entirely to individuals. Government officials did not even make a recommendation as to what they thought any individual should do. D.A. Henderson, the chief bioterrorist adviser to the Secretary of Health and Human Services (HHS), justified this failure to recommend for or against taking the anthrax vaccine by saying that there was insufficient information available to make a recommendation. But on what basis could individuals make a decision if those with the most experience with the anthrax vaccine refused even to advise them about what action was medically reasonable?
Although no survey of the exposed civilians has been conducted, it seems likely that the potential subjects mostly decided for themselves that their 60 days (or less) of antibiotics was sufficient protection. It is also unlikely that anyone who actually read and understood the information in the consent forms provided (for adults, adolescents, and children) would have chosen to take the vaccine. Specifically, the consent forms (which are essentially identical) are five-page, single-spaced documents. Designed for a clinical research trial, the forms are nonetheless captioned “Anthrax Vaccine and Drugs Availability Program for Persons Possibly Exposed to Inhaled Spores.” Most of the form is in regular typeface, but the following information is in bold: