Control of Extensively Drug-Resistant Tuberculosis (XDR-TB): A Root Cause Analysis
Jennifer Prah Ruger
The threat of global infectious agents has the potential to cripple national and global economies, as the outbreaks of SARS, Avian Flu, H1N1, and XDR-TB have demonstrated. This article offers a Root Cause Analysis (RCA) of one public health case study – the Speaker case of XDR-TB – pinpointing the
underlying causal relationships associated with this global health incident and proposing recommendations for preventing its recurrence. An RCA approach identifies corrective actions directed at the root causes of the problem and advances them as necessary to eliminate global contagion with its major international public health risks. To my knowledge, this is the first root cause analysis of a global health problem. The reform this article proposes would be to add a standardized procedure akin to the informed consent process in clinical ethics, but within a shared health governance framework. This approach, addressing infectious agents at their origins or source, is potentially a more effective strategy to reduce uncertainty and avert global health threats.
BACKGROUND AND INTRODUCTION
Drug-Resistant Tuberculosis and the Speaker Case
In May 2007, the United States government isolated an individual under Centers for Disease Control and Prevention (CDC) auspices for the first time since 1963 (when it quarantined a patient with smallpox). The 2007 patient was Andrew Speaker, from Atlanta, Georgia, who was thought to have extensively drug-resistant tuberculosis (XDR-TB). XDR-TB can be transmitted by air to others in close proximity and is highly fatal; in South Africa it has been found to
1be deadly in approximately 98 percent of cases.
The case (hereafter called the ―Speaker case‖) was complicated by
Speaker’s extensive travels, including two trans-Atlantic flights, some five flights
within Europe, and at least one cross-national car ride – an itinerary that
originated in the United States and included France, Greece, Italy, the Czech
2Republic, and Canada before ending back in the U.S. During his two long trans-
Atlantic flights, he could have infected other passengers, especially those within two rows of his seat. Further, county and federal health department officials (including the CDC) and Speaker himself believed he was infected with multidrug-resistant TB (MDR-TB) before he left the United States. Fulton
County health officials claim they warned him of the potential danger to others
3before his trip, but that he disregarded their warning. Mr. Speaker says county
4 officials at the time told him he was not contagious.In Atlanta, officials issued a
written directive against travel, but did not deliver it to his home before his
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departure, allegedly because Mr. Speaker moved his departure date up two
After Speaker’s departure, officials came to believe that he had the even more serious form of drug-resistant TB, XDR-TB, an extremely rare disease:
6only 49 U.S. cases were identified between 1993 and 2006. (Later, on July 3,
72007, doctors downgraded Speaker’s diagnosis from XDR-TB to MDR-TB.)
After the diagnosis, the CDC contacted him in Rome, asking him not to take commercial flights. While the CDC was making arrangements for his travel, he left Rome, took a commercial flight to Montreal, and drove to the United States
8by car. An agent at the Canadian-U.S. border let him into the country, though
9the agent knew that health authorities sought him.
At first glance, the case sounds eerily similar to the SARS (Severe Acute Respiratory Syndrome) outbreak that shook the globe in 2003, spreading to over 30 countries in just a few weeks, infecting 8,096 and killing 774 people
10worldwide. Since that time, the World Health Organization (WHO) and the World Health Assembly have revised the International Health Regulations (IHR), in part to help international and domestic health agencies plan, coordinate, and communicate both within and across countries to better respond to global
11infectious agents and to minimize their potential consequences. At the U.S.
federal level, Executive Order 13375 in 2005 amended the Public Health Services Act (PHSA) to add influenza to the list of quarantinable illnesses and heightened attention to the police powers of the state to isolate and contain infected
12individuals. These changes in international and U.S. federal health law notwithstanding, the Speaker case raises questions about the appropriate roles for international, federal, state, and local governments, along with health care personnel and individuals themselves, in addressing global infectious agents.
Root Cause Analysis
This article analyzes the Speaker case by employing Root Cause Analysis methodology. RCA has been used in a variety of situations, ranging from accident and failure analysis to operations and systems analysis. It holds significant promise for examining and solving global health problems. Global health encompasses complex systems and interrelated levels (global, national, local, individual), tools (laws, policies, norms), and actors (governments, nongovernmental organizations, health care personnel, individuals). RCA allows a comprehensive system-wide perspective that breaks down complex global health problems into increasingly smaller components, enabling in-depth analysis from one level and dimension to the next. RCA rests on the premise that getting at the root cause of a problem is more effective than addressing ―immediately obvious‖ symptoms, and that a problem typically has more than one root cause. RCA is especially applicable to global health because it takes both vertical and horizontal perspectives, and its end goals are uncertainty
reduction and risk avoidance. While a full description of RCA is beyond the
scope of this article, central features of the methodology include recursive questioning to identify causal factors and root causes related to a problem, and
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13identifying effective solutions to prevent recurrence. To my knowledge, this is
the first root cause analysis of a global health problem.
In applying the RCA methodology, this article identifies the components and questions involved in dealing with infectious diseases in a globalized world and offers recommendations for uncertainty reduction and risk management, using the Speaker case as an illustration. In the spirit of the recursive inquiry central to RCA, it poses and addresses several questions. For example, are voluntary compliance and a ―covenant of trust‖ through a voluntary memorandum of understanding sufficient to achieve infected individuals’
cooperation? Are U.S. and global health communities prepared for outbreaks of influenza or acts of bioterrorism? Julie Gerberding, CDC Director during the Speaker incident, issued a public statement acknowledging that the decision to issue a federal order of isolation under the PHSA was unusual, and said the CDC was aware of the need to balance individual liberties with protecting public
14health. Was the federally mandated isolation order in this case necessary or desirable, and was the order’s timing and scope appropriate and reasonable?
Should the CDC, Fulton County and/or Georgia state health departments have acted sooner and taken steps to prevent the case’s international ramifications? Which level of government should have spearheaded the endeavor? Did the patient act responsibly and ethically? The root causes of this international public health fiasco occupy a number of different levels and pertain to many aspects of law, ethics, governance, and the infectious agent itself.
The sections that follow take up the main four steps of RCA (problem definition, data collection, identification of possible causal factors and recommendation of potential solutions). In RCA, events and systems interrelate, so I seek to trace the events in the Speaker case to discover where and how the problem commenced and how events and conditions in specific areas (e.g., XDR-TB as a source of exposure, domestic public health law, international health law, quarantine, isolation, civil and political rights and voluntary compliance) affect actions in others. I begin this analysis with what RCA analysts might call physical or material causes — in this instance, the nature of XDR-TB itself as a source of exposure. I then move to organizational or system-wide causes, here with a focus on domestic and international laws and policies that guide individuals in making decisions on actions. I conclude with human causes focused at the individual level, examining specifically the notion of voluntary compliance. An RCA method called an Ishikawa or fishbone diagram (Figure 1) breaks down these factors in greater detail to assess their potential contribution to the global health problem. The final section offers recommendations for potential solutions to prevent recurrence.
EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS AS A SOURCE OF EXPOSURE
An important question in incidences involving infectious agents is the probability of exposure to those in the general population, especially groups with immune system impairments. In justifying the isolation order, Dr. Gerberding indicated that the ―precocious organism [XDR-TB] is so potentially serious and
could cause such serious harm to people, especially those that have other
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medical conditions that would reduce their immunity, we felt that it was our responsibility to err on the side of abundant caution and issue the isolation order to assure that we were doing everything possible to protect people’s
15health.‖ While the CDC and other health authorities cannot and do not require or compel testing for individuals who may have been exposed, health authorities do recommend that individuals in close proximity to an infected patient and with a compromised immune system receive the baseline skin test and the
16follow-up skin test for incubating TB infection. Moreover, some individuals
have special TB risk because of their own medical history and are especially vulnerable. XDR-TB is particularly problematic for individuals with HIV or other conditions weakening the immune system, who are at higher risk of both
17TB infection upon exposure and of death upon contracting TB. Identifying these
individuals, however, raises concerns about medical privacy and patient confidentiality.
XDR-TB is resistant both to two of the main first-line drugs (isoniazid and rifampicin) and to at least three out of six classes of available second-line drugs (fluoroquinolones and injectable agents, such as amikacin, kanamycin, and capreomycin). It most often develops when first- or second-line TB drugs are misused or mismanaged (when patients do not take the full course of treatment or doctors prescribe the wrong dosage, duration or drugs for treatment) and thus
18become ineffective. Treating XDR-TB successfully is difficult, because it
19requires finding an effective combination of four or more drugs. Currently no
20effective third-line drugs are available. Pharmaceutical companies have
neglected the development of a vaccine or better TB drugs because the market is
21not profitable enough to justify research and development investments. The
international community thus has only decades-old treatment options for contemporary strains of a contagious disease that can spread worldwide in a matter of hours. XDR-TB spreads like regular TB: by sneezing, coughing or
22talking, which propel bacteria into the air. Confined places like planes, where
ventilation is limited even though many airlines use HEPA filters to recycle and clean the air, amplify the risk of transmission. The stage of the disease also