Margaret A. Hamburg, M.D.
Commissioner U.S. Food and Drug Administration
Margaret A. Hamburg, M.D. testifies before the House Committee on Government Reform
Testimony of Margaret A. Hamburg, M.D.
Vice President of Biological Programs, Nuclear Threat Initiative
House Committee on Government Reform
Mr. Chairman and members of the Committee, thank you for holding this timely and important hearing on our nation’s preparedness to handle major public health threats. My name is Margaret (Peggy) Hamburg. I am a physician and a public health professional, currently serving as Vice President for Biological Programs at NTI, a private foundation, co-chaired by Ted Turner and Sam Nunn, whose mission is to reduce the global threat from weapons of mass destruction. Previously, I have served as Assistant Secretary for Planning and Evaluation in the Department of Health and Human Services; as New York City Health Commissioner; and as Assistant Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health. I have spent much of my time over many years working on issues of public health preparedness and response, particularly with respect to infectious diseases threats, both naturally occurring and intentionally caused. I also recently co-chaired, along with Dr. Joshua Lederberg, a recent report from the Institute of Medicine (IOM), National Academy of Sciences, entitled Microbial Threats To Health: Emergence, Detection and Response which examined a set of critical issues concerning microbial threats to health in the twenty-first century. I welcome this opportunity to offer my views on Severe Acute Respiratory Syndrome (SARS) and its implications for public health.
In my testimony this morning, I would like to address some of the important concerns raised by the emergence and ongoing response to the SARS outbreak, as well as broader issues of emerging infections, public health and security. In this context, I would also like to offer a brief review of the IOM’s Microbial Threats to Health report, which focused on the severe and urgent nature of the infectious disease threat and offered a series of recommendations to improve domestic and global capacity to detect and respond to the kinds of public health threats that we are now experiencing with SARS.
Severe Acute Respiratory Syndrome (SARS)
Severe Acute Respiratory Syndrome (SARS) represents a serious public health threat. Unfolding as we speak, it is surprising government officials and scientists around the globe, constraining travel, shutting down businesses, causing widespread fear and possibly threatening our security. SARS is a life-threatening pneumonia that, as of April 7, 2003, has infected more than 2,600 people, with 98 deaths. First appearing in China, it has now been reported in 18 countries. We are still uncertain as to the definitive cause of this emerging disease, and there is no known effective treatment. Transmission of the disease involves human-to-human spread, predominately through aerosol droplets. To date, between 3- 4% of those infected die. No one can predict how far the disease will spread and how much higher the toll will be. Will this outbreak be contained, or will it become the next global pandemic?
Many organizations and their leaders should be commended for the robust international response mobilized in light of the emergence of SARS. Yet SARS has demonstrated important outstanding needs and gaps in our systems for disease prevention, response and control. These will require increased domestic attention, but importantly also demand greater global cooperation and support. For example, failures to initially report this unusual syndrome appearing last fall in China’s Guangdong Province likely represents a missed opportunity for rapid outbreak investigation and disease control. Time lags in getting samples to the best labs around the world for evaluation no doubt added further significant delays to an already difficult diagnostic challenge. Continuing spread though human contact and travel has now dispersed the disease around the globe, yet there is not an adequate system for global disease surveillance to assure the necessary disease tracking; nor is there a coordinated system to assure appropriate action and response when cases appear. And clearly we need more research to provide better diagnostic tools, as well as the drugs or vaccines necessary to treat or prevent disease.
In addition, SARS has demonstrated how easily health care systems can be overwhelmed by the demands for patient screening and care, particularly with the special infection control requirements that come with a respiratory illness of this kind. Similarly, it has revealed troubling questions about how and when travel and commerce should be constrained in the context of communicable disease. On both the domestic and international level, a great deal more work must be undertaken to develop appropriate policies, define authorities and design strategies for implementation.
These are fundamental issues, both with respect to the current SARS outbreak and in terms of our broader health and security needs to protect against a set of serious infectious disease threats. We must recognize that SARS is but one of a series of new and deadly infectious diseases that have emerged in recent times–not to mention old diseases that have resurged, often in new and more frightening forms because of the development of drug-resistance. What is more, we live in an era when we must think seriously about the potential for intentional use of biological agents as weapons to do harm, possibly even with genetically engineered organisms produced to enhance their lethality or infectivity.
The Ongoing Threat of Infectious Disease
Several decades ago, there was enormous optimism that the threat of infectious diseases was receding. Scientific and technologic advances, including the development of antibiotics and vaccines, along with improved sanitation and vector control enabled the control and prevention of many infectious diseases, particularly in the industrialized world. However, we know today that such optimism was premature. It did not take into account many critical factors such as:
As we enter the 21st century, infectious diseases continue to burden populations around the world. Both naturally occurring diseases and the possibility of bioterrorist attacks hold increasing potential to cause sickness, disability, and death. The ability of infectious agents to destabilize populations, economies, and governments is fast becoming an unfortunate fact of life. Moreover, because national borders offer little impediment to such threats, especially in today's highly interconnected and readily traversed "global village," one nation's problem soon can become every nation's problem.
Over the past decade, the United States has taken important steps to strengthen its capacity to address the threats posed by infectious diseases. But the present reality is that we are inadequately prepared. Looking to the future, we must realize that public health is public safety, and an essential pillar in our national and international security. We must do more to improve our ability to prevent, detect, and control emerging as well as resurgent microbial threats to health. The best defense against any outbreak is robust public health science and practice. Given our significant–and growing–vulnerabilities, markedly greater attention and resources must be devoted toward this end, and we must recognize that effective strategies will require greater coordination and cooperation with partners around the globe. Without question, we must work now to create a system that really works so that we will be prepared for the next attack–whether it is mother nature or an act of bioterrorism.
Microbial Threats To Health: Emergence, Detection and Response
Several weeks ago, the Institute of Medicine (IOM), National Academy of Sciences, released a new report focused on microbial threats in the twenty-first century. The report, Microbial Threats To Health: Emergence, Detection and Response, represents an effort to describe the spectrum of microbial threats to national and global health, the factors affecting their emergence or resurgence, and measures needed to address them. The major thrusts of this report–and its recommendations–are almost uncannily relevant to our current experience with SARS. As co-chair of the report committee, I would like to briefly discuss some of our major themes and conclusions.
This report serves as a successor to the landmark 1992 IOM report on emerging infections, which provided a wake-up call to the nation about the risk of infectious diseases and the need to avoid complacency. In the decade since that first report was published, the impact of infectious diseases on the United States has only increased. Illnesses unknown in the United States only a few years ago, such as West Nile encephalitis and hantavirus pulmonary syndrome, have emerged to kill hundreds of Americans. Meanwhile, old diseases such as measles, tuberculosis, and malaria–which were thought to be a thing of the past in the United States–have reappeared, sometimes in epidemic proportion. Similarly, gains made against sexually transmitted diseases have slowed or reversed in certain population groups. And of course, HIV/AIDS continues to take a devastating toll.
Compounding the danger posed by these infectious diseases are two other important trends. First, antimicrobial resistance has become pervasive not only in the United States but also worldwide. Second, we must now deal with the intentional use of infectious agents as weapons. The new report does not focus exclusively on the United States as a venue for microbial threats to health because it must be increasingly recognized that these are global problems that require global solutions. Nor does the report focus solely on newly emerging diseases when it is evident that there remains a long way to go to in effectively addressing known diseases, including those appearing in new forms or new places. We did limit the focus of this report to human health, but placed significant emphasis on zoonoses, or animal infectious diseases that affect humans.
First, we considered it important to outline the factors that lead to the emergence of infectious disease. More than a dozen factors–some reflecting the ways of nature, most of them reflecting our ways of life–are described in the report to account for new or enhanced microbial threats. Any of these factors alone can trigger problems, but their convergence creates especially high-risk environments where infectious diseases may readily emerge or re-emerge, take hold, and spread. In our transforming world, conditions are ripe for the convergence of multiple factors to create microbial “perfect storms” –yet unlike meteorological perfect storms, these events would not be once-in-a-century events, but frequent or ongoing. SARS is not an isolated event.
An effective national response to infectious diseases must be a global response. Therefore, our recommendations begin with a strong call for the United States to enhance global disease surveillance as well as the capacity to respond to infectious disease threats, recognizing the heightened need that exists in the developing world. Our efforts should be coordinated by key international agencies, such as the World Health Organization, and based in appropriate U.S. federal agencies, such as the Centers for Disease Control and Prevention and the Department of Defense. Moreover, these efforts should involve collaboration with private-sector organizations and foundations. Investments should take the form of financial and technical assistance, operational research, enhanced surveillance, and efforts to share both knowledge and best public health practices across national boundaries. Sustainable progress and ultimate success in these efforts will require health agencies to broaden partnerships to include non-health agencies and institutions.
The report stresses the need to bolster the U.S. public health infrastructure, which has suffered from years of neglect. SARS underscores the urgent need to increase core capacities of our public health system to detect, track and contain infectious disease. State and local health public health departments represent the backbone of our ability to respond effectively to a major outbreak of disease, whether naturally occurring or a bioterrorist attack. Yet we have never adequately equipped these public health agencies to do that job. In fact, many hesitate to even call the array of health structures at the state, county and local level a public health “system” because years of relative neglect and underfunding have left them undercapitalized, fragmented and uncoordinated.
Upgrading current public health capacities will require us to strengthen and extend effective disease surveillance systems, laboratory capacity, communication skills, and systems to ensure the rapid use and sharing of information. Expanded prevention and control measures must be implemented by an adequately trained and competent work force. Unfortunately, there are many troubling shortfalls in both the capacity and expertise of the present work force, as well as in the systems for training future generations.
The report also addresses the fact that the reporting of infectious diseases by health care providers and laboratories remains inadequate. Open lines of communication are essential to robust systems of surveillance, investigation, and response. We need greater understanding and partnership between public health and medicine, and we need to take advantage of information technology to enhance efficient reporting, including the electronic reporting of laboratory results. In addition, the report strongly encourages the integration of new tools for surveillance into practice. We call for the development and use of better diagnostics–simpler, quicker and hopefully more cost-effective–to enhance the quality of disease surveillance. We also recognize the promise of syndrome surveillance, but stress the critical need for rigorous evaluation of existing and emerging approaches, as well as the need to explore strategies for harmonization and integration of those approaches that are proven effective so that information can be shared and compared across geographic regions.
The committee was deeply concerned about the current and future arsenal of drugs and vaccines to address microbial threats to health. To be blunt, it was felt that our nation–and the world–faces a serious crisis with respect to vaccine and drug development, production, and deployment. The challenges here are many, varied and complex. Solutions will require a novel, coordinated approach among government agencies, academia and industry. Issues that must be addressed in a more meaningful and systematic fashion include the identification of priorities for research, the determination of effective incentive strategies for developers and manufacturers, liability concerns, and streamlining of the regulatory process.
Up until now, the federal government has neither addressed these challenges at a sufficiently high level, nor provided adequate resources. Only by focusing leadership, authority, and accountability at the cabinet level can the federal government meet its responsibility for ensuring innovative and adequately funded research on existing and emerging diseases, as well as an ample supply of antimicrobials and vaccines. In that spirit, the secretary of the Department of Health and Human Services should work closely with other relevant federal agencies, Congress, industry, academia, and the public health community to define and implement a national strategy.
To avert an imminent crisis resulting from microbial agents' increasing resistance to available drugs, the committee recommends procedures to alert stakeholders to the problem and more finely target the use of antimicrobials. This requires, first, expanded outreach and better education of health care providers, drug dispensers, and the general public about inappropriate use of antimicrobials. Second, it requires the increased use of diagnostic tests, as well as the development and use of more rapid diagnostic tests, to determine the sources of infection and thereby ensure more appropriate use of antimicrobials. In addition, there should be a ban on the use of antimicrobials for growth promotion in animals if those classes of antimicrobials are also used to treat disease in humans.
Other recommendations address ways to control vector-borne diseases and diseases that can spread from animals to humans. The report also describes the need for a comprehensive infectious-disease research agenda for the United States and the establishment of interdisciplinary infectious-disease centers.
The continuing efforts to identify and contain SARS reminds us that we must always be ready today for the unexpected health threat of tomorrow. While it will never be possible to fully prepare for every potential, imaginable threat, there is a great deal that can and should be done. In this time of heightened anxiety and concern, our nation has a real opportunity–and obligation–to make sure that we have in place the programs and policies necessary to better protect against microbial threats.
Certainly, the experience with SARS reinforces the need for improved global disease surveillance and reporting, linked to a rapid investigation and response capability, including adequate and appropriate diagnostic laboratory capacity. The response to SARS underscores the importance of strong public health systems, from the global to the local, as well as integrated and well-functioning systems for health care delivery. Future preparedness will also depend on a well-educated and trained clinical and public health workforce. In addition, we need a sound research agenda addressing near and long term requirements for new insights into the nature of infectious disease threats, human host responses, and the opportunities to develop new diagnostics, drugs and vaccines.
Dramatic advances in science, technology, and medicine have enabled us to make great strides forward in our struggle to prevent and control infectious diseases, yet we cannot fall prey to illusions and complacency. The emergence of SARS, a previously unrecognized microbial threat, is a powerful reminder of our continuing vulnerability. We must understand that pathogens–old and new–are endlessly resourceful in adapting to and breaching our defenses. We must also understand that factors relating to society, the environment, and our increasing global interconnectedness actually enhance the likelihood of disease emergence and spread. Moreover, it is a sad reality that today we must also grapple with the intentional use of biological agents to do harm, human against human.
Thus the prevention and control of infectious diseases are fundamental to individual, national, and global security. Failure to recognize–and act on–this essential truth will surely lead to disaster. The magnitude and urgency of the problem demand renewed concern and commitment. We have not done enough–in our own defense or in the defense of others. As we take stock of our prospects with respect to microbial threats in the years ahead, we must recognize the need for a new level of attention, dedication, and sustained resources to ensure the health and safety of this nation–and of the world.
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