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IOM Forum on Emerging Infections, 15th Anniversary Symposium

Margaret A. Hamburg MD
December 12, 2012

I am delighted to be part of this symposium celebrating the 20th Anniversary of the IOM Forum on Microbial Threats: Emerging Infections, Microbial Threats to Health, and the Microbiome. I am so sorry that other responsibilities prevented me from participating in the entire meeting, but I want you to know that I left a meeting in Paris after only 24 hours there—and only one fabulous meal—in order to get back in time to be part of this important event.

I suspect that there is very little that I can add to the packed agenda of these two days…the distinguished speakers and rich discussions. But as this symposium comes to an end, I appreciate the opportunity to offer some reflections on the Forum—past, present and future.

This Forum has been really quite remarkable. From the very beginning, it has made a real difference…bringing together experts from a wide range of disciplines, organizations and sectors… identifying and highlighting key topics for research, for policy-making and for medical care and public health preparedness.  Through its meetings, workshops and publications, the Forum has been able to dramatically increase understanding—and stimulate action—on pressing issues such as the factors that influence the emergence and spread of new infectious diseases and the resurgence of old ones, antimicrobial resistance, pandemic disease, foodborne disease and food safety, vector-borne and zoonotic diseases.

The Forum has helped set forth strategies to improve infectious disease surveillance, identify critical research needs, and develop more effective strategies for response to microbial threats. In fact, the Forum’s work has helped to define whole new areas of research and practice, from biological threats and terrorism to climate change and infectious disease threats, microbial ecology, the microbiome, and more.

On a very personal level, I must say that the Forum has had a profound impact. For one thing, it has been the source of so many friends and colleagues over the years. And through the work and activities of the Forum, I have had the opportunity to grow and learn in so many extraordinary ways. I suspect that I am not alone in these sentiments and experiences. It is an extraordinary group, and the accomplishments and contributions have been astonishing.

I thank the IOM for making this possible, and all the many leaders, Forum members and Forum staff, who have made this vibrant and dynamic enterprise possible and so successful.

And, of course, it is impossible to reflect back on the work of the forum without recognizing the powerful influence of the late Joshua Lederberg. There from the very beginning, as co-chair with Robert Shope of the pathbreaking 1992 report, Emerging Infections: Microbial Threats to Health in the United States, Josh had an uncanny ability to anticipate so many of the infectious disease threats and trends that would soon declare themselves, and to engage the best minds—wherever he found them--to help further understanding of these concerns and how best to address them.

I think he taught us all how with leadership, vision, and determination, the best science could be brought together with policy analysis to significantly influence decision-making, galvanizing new fields of research, new practice strategies and reshaping critical government programs and policies.

It is hard now to really remember that it was not so long ago that there was enormous optimism that the threat of infectious diseases was receding. As a medical school student I do recall being taught that. And going back a little further, I recall the now often quoted Surgeon General of the United States who in testimony to Congress, ventured to say that we could soon “close the book” on the era in which infectious diseases represented a serious threat to health. Back then, smallpox was on the verge of eradication, and health officials had targeted measles, malaria, polio and other diseases for elimination as powerful drugs and vaccines were readied to defeat microbial foes. 

However, we know today that such optimism was premature. It did not take into account many critical factors such as:

  • the extraordinary increases in international travel, immigration and trade;
  • the movement of people into urban settings—many into megacities-- where opportunities for disease spread are amplified through crowding, along with poor sanitation and hygiene;   
  • changing agricultural practices and environmental manipulations that alter disease vectors as well as opportunities for exposure;
  • the continuing difficulties of translating existing medical knowledge and tools into action for all who need it, whether because of inadequate resources, ignorance or complacency;
  • and, of course, the extraordinary resilience and adaptability of the microbes themselves

In the early 1990’s, Josh was one of a few strong and cogent voices speaking to the importance of these issues, both for our nation and the world.  The IOM offered a wonderful forum—literally and figuratively—for his vision to coalesce and take hold. In that landmark Emerging Infections  report in 1992, along with a few colleagues, a wake-up call was issued to the nation about the risk of infectious diseases and the need to avoid complacency. As a result, important steps were taken to strengthen our ability to prevent, detect, and control emerging—as well as resurging—microbial threats to health. Nonetheless, efforts remained fragmented and under-resourced, leaving the public health, medical care, and veterinary health communities inadequately prepared. A decade later, the IOM revisited that report—and I had the privilege of co-chairing the Committee with Josh. And of course, Mark Smolinski made an indispensable third as the Study Director, along with an extremely able and committed committee membership.

We delved into the spectrum of microbial threats to national and global health, the factors affecting their emergence or resurgence, and measures needed to address them. But we hardly needed an expert committee to recognize that in the time since that first report, the impact of infectious diseases had only increased, in the United States and internationally.

That sad reality was distressingly reinforced by the fact that the anthrax letters—the first documented deliberate and lethal biological terrorism attack in our nation’s history—occurred while we were working on our report. In addition, the report’s release was eerily timed with the unexpected emergence of SARS.

As we talked with policy-makers, professional colleagues and the public, it was clear that many were stunned by the sudden appearance of severe acute respiratory syndrome (SARS) and how quickly it spread around the world, afflicting multiple countries in 2003. Many were equally surprised at the power of the disease to cause major social dislocations, undermine confidence in government and other institutions, and impose costs in the billions to affected regions and industries. 

But it certainly underscored the message of the report: diseases with epidemic potential are realities of the world we live in—emerging, re-surging and traveling the world at an unprecedented pace as a consequence of the conditions of modern life.

And just as disease threats know no borders, risks from unsafe food and medical products are inherent in the global path to market. As I appreciate now more than ever in my current role, at every step in global supply chain networks-- from raw materials and other ingredients, to manufacture, storage, sale, and distribution-- a product can be become unintentionally contaminated, or can be deliberately counterfeited, or adulterated.

In many parts of the world, antimicrobial resistance is accelerated by the growing prevalence of sub-standard and counterfeit medicines, undermining global health efforts, including effective infectious disease treatment and contributing to the growing threat of antimicrobial resistance.

Obviously antimicrobial drug resistance, here and around the world, is not simply the outgrowth of substandard/contaminated drugs, but it also reflects the inappropriate use of these important products by health care providers and patients…and in growth promotion in animal husbandry. We have watched as drug resistance has made once easily managed diseases far more difficult to treat and rendered an increasing number of pathogens virtually untreatable.

And sadly, the threat of contaminated products is a home-grown problem as well. Today, we are in the midst of the devastating outbreak of fungal meningitis and other infectious disease complications because of deplorable conditions in a compounding pharmacy.

Now more than a decade into the 21st century, infectious diseases continue to burden populations around the globe. As this group knows so well, new and serious infectious diseases have emerged, and we’ve watched old diseases resurge, sometimes in epidemic proportion, sometimes in new geographic regions and often in new and more dangerous forms thanks to drug-resistance. 

We have made remarkable improvements against some deadly foes—certainly the treatment of HIV being one example, But we have seen progress against others. -- for example,some sexually transmitted diseases -- slow down or reverse in certain populations, despite effective treatments. 

In addition, many diseases once thought unrelated to infectious disease, are now known to be the result of chronic infections. Many such examples come from the realm of cancer, such as HPV and cervical cancer, or liver cancer and hepatitis B and C, but also things like ulcers and coronary heart disease.

What is more, we live in an era when dangerous pathogens can be grown or produced with ever simpler techniques in laboratories around the world. We must think seriously about the potential for inadvertent release or exposures, but also the intentional use of biological agents as weapons to do harm, possibly even with genetically engineered organisms produced to enhance their lethality or infectivity.

We have enough problems to keep this Forum in business for a very long time I’m afraid! Without a doubt this group has brought much needed attention to microbial threats to health, in all its many dimensions, Certainly, thanks to the work of so many here—punctuated by real world events and the occasional crisis-- the issue of emerging and re-emerging infections has stimulated flurries of interest and concern. But overall, there remains far too much complacency about the threat before us.

It is, I suppose, a great tribute to the confidence of policymakers and the public in the ability of scientists to solve problems and keep the world safe…but, as Josh would remind us, this represents a clear underestimation of the power and capabilities of our adversaries, the microbes.  In the competition between people and pathogens, eternal vigilance is the price of survival.

And as Josh has frequently pointed out, the best defense against any infectious disease outbreak is a robust and global system for public health—both its science and its practice.  While progress has been made, a range of critical elements demand further attention and dedicated action.

You have talked about many of them over the course of this meeting…and in past work of the Forum, but we must continue to address them-- highlighting issues, strengthening understanding, and shining a light on the best pathways to find meaningful and enduring solutions to the problems we face. Some will involve breaking new ground, revealing new science or defining new domains of necessary study or activity. For other issues, it will be simply keeping up the drumbeat of concern.

Among many issues, we must dramatically improve capacity for global disease surveillance and reporting, linked to a rapid investigation and response capability, including adequate and appropriate diagnostic laboratory capacity. We must also strengthen institutional public health capacity, from the local to the global level, as well as integrated and functioning systems for health care delivery, whether in the context of routine or catastrophic events. Future preparedness will also depend on a well educated and trained scientific, clinical and public health workforce, with adequate resources to do their jobs…and there are real reasons for worry here.

Furthermore, as I know you all appreciate, a key to future disease prevention and health protection is a sound research agenda addressing near and longer term requirements for new insights into the nature of infectious disease threats, human host responses, and a deeper understanding of the relationship of our species to our broader environment, other animal and plant species and the vast microbial world. We also desperately need to develop new diagnostics, drugs and vaccines, leveraging the opportunities of advancing science and technology.

It is striking, how many of these issues the Forum has taken on over the years…and a host of other things as well.  But there is much more to be done. Before closing—and I know that this has been a very full two days and some of you have planes to catch—I do want to say something about the path forward.

Without a doubt, the Forum will have a continuing role…and in the best tradition of this great organization.  Remember that the National Academy of Sciences, of which the IOM is the medical/public health arm, was created as an institution of science “to guide public action in reference to science matters." 

Well, the Forum on Microbial Threats is ideally situated to provide this vital service. There are few other fora that bring together so many of the relevant but very different kinds of scientists, thinkers, practitioners, policy-makers, and rainmakers—across disciplines and across sectors. This ability to convene…and over time to build strong working relationships and a foundation of common understanding, trust and communication…enables the Forum to make its very special contribution—as it has in the past and will going forward.

It is striking how much this really matters, and how the content and focus of the Forum has deepened and evolved in important ways that likely would not have occurred so productively without this diverse membership and the rich discussions that ensued.  From an initial strong and important focus on the phenomenon of emerging infectious disease threats, the factors evolved…and then the strategies to detect, characterize and respond to those events. The forum’s work then began to delve down into the complexities –and the complex inter-relationships of the various factors in emergence, bringing in more disciplines and more perspectives.

More recently, the Forum has moved beyond the notions of combating microbes and their threat to a far more nuanced examination of microbial biology and ecology, recognizing the intertwined relationships among microbes, humans, animals and plants…for better and for worse. And, of course, the concern about the growing potential for man-made microbial threats.

Moreover, the relationships that began as part of the forum’s work have had cascading benefits, with projects and activities and important research begun external to the forum—between individuals and institutions/organizations—but because of the forum.

This has certainly proven true for me in my current role as FDA Commissioner. I was required to step down from Forum membership when the Senate confirmed me in this new position, but the connection was firmly entrenched. 

The links are important and I want to just quickly mention a few of our key issues that intersect with the work of the Forum…areas of high priority for FDA but also in the broader effort to address microbial threats to health. I can readily envision important work t that we can do together.

As we look at the challenges before us, one pressing issue is obviously the requirement for new and better drugs, diagnostics and vaccines. There can be no doubt that we need a robust medical product enterprise that reflects both changing needs and the opportunities that exist in science and technology today. Yet we all recognize that the drug development pipeline for new antibiotics is distressingly low, and especially for ones that are truly innovative.

This is a major concern…and there are many complex reasons that underlie this worrisome trend-- some that are common across all medical product development, and some that are unique to the realm of infectious diseases. 

Overall, the time and costs of drug development are significant barriers. This becomes an increasing challenge for antibiotics, used for short-course treatment as opposed to chronic illness, which means that the market opportunity may be less attractive for investment by drug companies. There may be additional restrictions to market returns because of medically important efforts to safeguard and limit antibiotic use. Layered on top of these concerns, are regulatory and scientific uncertainties and challenges. FDA must be focused—and proactive—in addressing these concerns.

At the FDA, we are acutely aware of our obligation to make sure that advances in biomedical research are translated into therapies that matter to patients…but we cannot do it alone. This translation requires regulatory flexibility in light of continually changing needs and circumstances, but it also demands that we advance science.

For one thing, we need to develop much more focused research and development efforts that harness advances in science, for instance, to develop antibiotics that act via new mechanisms that reflect our best understanding of potential drug targets, disease pathogenesis, and human immune response.

And we need better, more advanced strategies for evaluating the safety and effectiveness of new antibiotics once they are in development. For example, biomarkers are proving their benefit for predictive toxicology---if a drug is going to fail, best that it fail early.
In addition, it is essential that we pursue more innovative and adaptable approaches to clinical trials that reflect the need for rigorous scientific answers but are realistic about constraints, such as the number of patients, the size and length of studies, and the cost of the trials. This requires new insights into the diseases to be treated that can offer the identification of appropriate biomarkers or surrogate endpoints that can help support faster paths to assess the efficacy of various therapeutic interventions and support efforts to optimize clinical trial design.

We also must think more creatively about the types of products or therapies that are really needed. For example, as we know from experience with HIV and TB and other diseases, effective interventions may require attacking the disease process at several points of vulnerability.  Traditionally, FDA required drugs for combination therapy to be developed, reviewed and approved in a serial manner, but while this was scientifically more manageable, the health of the public requires another approach. We have encouraged sponsors to look to developing drugs in combination, and to support this effort, we published a guidance written to help clarify strategies to co-develop two or more novel drugs to be used in combination and to provide advice on addressing the scientific and regulatory issues that may arise.

However, real success will be achieved when the scientific understanding of the underlying mechanisms of disease and the human immune response are delineated to provide the targets for such therapeutic development.

In a different but related domain, of great concern is the fact we are without many of the medical countermeasures—the drugs, vaccines and diagnostics-- needed to combat known threats—and we lack the capacity to rapidly develop new countermeasures in the face of new threats.

This is unacceptable. We need a far more flexible, nimble system to respond rapidly in the face of any attack or threat.  As part of a broader HHS effort to strengthen the Public Health Emergency Medical Countermeasure Enterprise, FDA has launched an initiative to support the development and availability of medical countermeasures.

It is certainly an area where there is a compelling and urgent need to translate advances in science and technology into new and better products…But it is also an area of enormous challenge to resolve outstanding scientific issues, to develop new models, platforms and technologies, and to develop the tools and regulatory pathways necessary to support the development of new medical countermeasures, especially where study populations are limited and market incentives are lacking or unpredictable.

These are all examples of how we at the FDA are trying to facilitate the development of innovative new products with acceptable safety and efficacy profiles.

We are making real progress.

But these are all areas where our success will be greatly enhanced by collaboration with partners outside our agency…partners such as those represented in the membership of the Forum. More specifically, these are issues where a cross-cutting, highly expert group such as this one can help to define some of the key opportunities and strategies to address them—in the domains of science, medical care, by identifying unmet public health needs and examining the kinds of potential policy prescriptions or program initiatives that may be required to make a difference.

I will certainly continue to look to this group for both the rarefied scientific insights and the common sense solutions that the Forum and its various activities has provided now for so many years.

Thank you all