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Homeland Security

Testimony of Dr. Ronald Crystal to the House Select Committee on Homeland Security

Chairman Cox, Ranking Member Turner and Members of the Committee, thank you for inviting me to present to the Committee a scientific assessment relating to "Project Bioshield". I am Dr. Ronald Crystal, Professor of Medicine, Chairman of the Department of Genetic Medicine, and Chief of the Division of Pulmonary and Critical Care Medicine at Weill Medical College of Cornell University - New York-Presbyterian Hospitals in New York City. I will focus my remarks on the scientific aspects posed by the threat of the use of infectious agents for bioterrorism, the feasibility of preventing the spread of disease caused by these agents, and how the academic community can contribute to this effort.

We believe the threat is very real. While control of access to these agents will help, we cannot lower the risk to zero. If a group wanted to spread a bioterrorism agent in a populated area, it would not be difficult, particularly in the context where the perpetrators are willing to give up their lives to carry out an attack. As you know, there is a long list of bacteria, viruses, and other pathogens that, if introduced into a populated area, could quickly spread undetected through the population, with resulting morbidity and death and consequent social and economic disruption. These organisms are readily available and many are found in nature. Even most of the so-called class A select agents are not difficult to obtain.

The 2002 Public Health Security and Bioterrorism Preparedness and Response Act requires federal registration for possession and transfer of select agents. All laboratories possessing and working with these agents are required to resister these pathogens, to identify the individuals that have access to these organisms, and to have in place a Select Agent Safety Plan for handling and accounting for all select agents. This is a positive step and will reduce the risk of these agents being available to potential bioterrorists. Even so, keep in mind that biologic agents by their very nature reproduce themselves. It is relatively easy, in a laboratory as small as 100 sq. ft. with equipment and reagents that are readily available and technology that is known to thousands of individuals in our country and around the world, to reproduce sufficient amounts of bioterrorism agents that, if released into the environment of a populated area, could result in massive disruption to society.

One of my responsibilities is to run the Medical Intensive Care Unit at the Weill Cornell Medical Center of New York-Presbyterian Hospitals. Our Intensive Care Unit is as modern and as high tech as any in the world, our physicians are trained to deal with the diseases that can be caused by the biologic agents of bioterror, and we have specific disaster plans in place to deal with a bioterrorist attack. Even so, the facilities of our hospital, and those of any of the medical facilities in our country, would be quickly overwhelmed if hundreds of patients with a highly infectious disease were to come to the hospital over a short period of time.

In the context of these realities, we have no choice other than to invest our resources to protect ourselves from the potential of bioterrorism in our country. This Committee's consideration of Bioshield is central to that effort.

How can the resources of our country be mobilized to meet the challenge of Bioshield? Between the academic community, guided by the efforts of Tony Fauci and the National Institute of Allergy and Infectious Disease and the pharmaceutical and biotech industries, we can get it done. Collectively we have the expertise and the infrastructure to create new generations of vaccines, monoclonal antibodies, and small molecule drugs to prevent and treat diseases caused by bioterror pathogens.

What should our strategy be? The list of potential bioterror agents is large, and it simply is not rational to believe that we could immunize everyone in our country against every possible agent. Not only is the list of possible agents too large, but inherent in any prophylactic therapy is the risk of adverse effects. While these risks may be small, when put in the context of the entire population, the risk-benefit analysis suggests the risk and cost for immunizing everyone against everything argues against this approach. I believe the strategy should be to leverage the exploding knowledge of the genetic revolution to develop new generations of vaccines and therapies against the most probable agents, and then stockpile the effective vaccines and therapies to be used in response to an attack.

The biomedical academic community in the US is unequaled in the world in regard to expertise, depth and infrastructure. It can be rapidly mobilized to focus on this challenge, and should be able to develop strategies to protect against and treat these disorders. With the information provided by the genetic revolution, the academic community can move quickly to develop safe, effective, and versatile platform technologies in which to provide the Bioshield relevant to protect our population. In addition to being safe and effective, there are several features of new generations of vaccines and therapies that are specific to the bioterror threat.

First, if our defenses are going to be stockpiled and used in response to an attack, they must be rapidly acting.

Second, we must be cognizant that the technology is widely available to genetically modify potential bioterror agents to circumvent existing vaccines and therapies. For some agents, this has already been done, such as the creation of strains of anthrax that are resistant to conventional antibiotics. Thus, we have to develop "platform" vaccines and therapies that are sufficiently versatile to meet this potential threat.

Third, while our universities, institutes, and hospitals can develop the strategies for these vaccines and therapies and carry out proof-of-principle studies in experimental animals and in small human trials, the academic community does not have the infrastructure, expertise, or resources to turn these new generations of vaccines and therapies into large amounts of final products that would meet the necessary safety criteria for large scale human use. This final step is critical to the overall effort and will require a partnership of the academic community and the pharmaceutical and biotech industries. In this context, it will be important that strategies be developed to make working in this area attractive as a commercial opportunity for the pharmaceutical and biotech community.

Finally, because of the very nature of the threat, it is not possible to test the efficacy of these new bio-defenses in humans in terms of protecting against the actual bioterror pathogens. In this regard, the Food and Drug Administration will need to work with Congress to develop new paradigms for approval of Bioshield products based on surrogate measures of efficacy, rather than the classic demonstration of efficacy in humans against the specific pathogen per se.

In closing, I thank the Chairman and the Members of the Committee for the opportunity to help you in your deliberations regarding Bioshield, a national strategy that I and my colleagues in the academic biomedical community strongly support.

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