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June 10, 2002
Madam Chairwoman and Members of the Subcommittee,
I am Dr. Elias Zerhouni, the Director of the National Institutes of Health. Thank you for the opportunity to appear before you today to discuss NIH's role in biodefense and public-private research partnerships. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), whose institute has the lead responsibility for biodefense research, also is here today and will provide you with details on our current plans regarding this important area of homeland security.
As you know, last week the President announced plans for the creation of a Department of Homeland Security. This Department would be responsible for several distinct capabilities and institutions that focus on specific elements of this mission. The Department would unify much of the federal government's efforts to develop and implement scientific and technological countermeasures to chemical, biological, radiological, and nuclear (CBRN) terrorist threats. The Department would also provide direction and establish priorities for national research and development, for related tests and evaluations, and for the development and procurement of new technology and equipment to counter the CBRN threat. The Department would incorporate and focus the intellectual energy and extensive capacity of several important scientific institutions, including NIH and other Department of Health and Human Services (DHHS) agencies, Lawrence Livermore National Laboratory (currently part of the Department of Energy) and the Plum Island Animal Disease Center (Department of Agriculture).
The Department would unify our defenses against human, animal, and plant diseases that could be used as terrorist weapons. The Department would sponsor outside research, development, and testing to invent new vaccines, antidotes, diagnostics, and therapies against biological and chemical warfare agents; to recognize, identify, and confirm the occurrence of an attach; and to minimize the morbidity and mortality caused by any biological or chemical agent. We will be working with the Administration on the development of this overall plan.
Biodefense research at NIH began long before the spate of anthrax cases that shook the Nation last year. NIH has been working collaboratively with other Federal agencies, including the Department of Defense and the Office of Homeland Security, and also with our non-governmental partners, in conducting basic research and vaccine development regarding agents that potentially could be used as weapons of bioterrorism. NIH also works closely with state and local officials as part of an overall strategy of national biodefense. The President's budget request for Fiscal Year 2003, which includes $1.75 billion for NIH biodefense, will enable us to expand our ongoing activities in such areas as basic research, comparative genomics, diagnostics, and vaccine and therapeutics development. It also includes funds for the construction of additional biosafety laboratories to ensure that all Americans - especially our local neighbors - will not be exposed to unnecessary risks resulting from biodefense research.
Incidentally, NIH also was involved in regional efforts to respond to anthrax attacks last fall. A detailed assessment of the fatal cases of inhalation anthrax that occurred in two District of Columbia postal workers was conducted by an NIH Clinical Center researcher, in collaboration with physicians in Maryland and Washington D.C. The results were published in the Journal of the American Medical Association, and were presented so that physicians would know what to look for when diagnosing suspected anthrax patients. The study was conducted in collaboration with the Johns Hopkins Center for Civilian Biodefense Studies, physicians at the Greater Southeast and Southern Maryland Hospitals, and the Washington, D.C. and Maryland Medical Examiners Offices.
Following the September 11 events, the National Institute of Environmental Health Sciences (NIEHS), through its Worker Training Program, prepared rescue and recovery personnel who would be working amidst the rubble at the World Trade Center site. We also sent NIH medical personnel to the site to provide assistance during the rescue period.
The NIEHS is funding six training grants and six research grants to address immediate and long-term worker and community health protections arising from the World Trade Center attacks. A total of $6 million will support education and training efforts, including training new and current hazardous material teams for the New York City Fire Department, environmental remediation workers, site cleanup workers and hazardous material teams that respond to weapons of mass destruction. In addition, a total of $4.5 million will support research organizations' efforts to conduct exposure assessment, epidemiology, and community outreach in the Lower Manhattan area. One of the recipient organizations collaborating with NIH is the Johns Hopkins University in Baltimore, which will develop a registry of the estimated 3,000 to 4,000 workers involved in cleanup at the World Trade Center site, for study by questionnaire and function tests, and to conduct outreach to the workers.
The NIH is also conducting research to explore the ways in which the September 11 attacks affected substance abuse issues and mental health. A recent study funded by the National Institute of Drug Abuse (NIDA), and reported in the June 1 issue of the American Journal of Epidemiology, found that smoking and alcohol and marijuana use increased among residents of Manhattan during the five to eight weeks after the terrorist attacks on the World Trade Center. Conducted by researchers at the New York Academy of Medicine, the survey showed that almost one third of the nearly 1000 people interviewed reported an increased use of alcohol, marijuana, or cigarettes following the September 11 attacks.
In April, the National Institute of Mental Health (NIMH) awarded new grants for research on mental health needs resulting from the September 11 attacks. NIMH funded these studies through its Rapid Assessment Post Impact of Disaster (RAPID) grants program, which solicits and expedites pilot projects. As an example of the research funded under this program, one of the projects will include a survey of the New York metropolitan area to determine what effects the 9/11 attacks have had on symptoms, mental disorders and use of mental health services. In another project, researchers will assess post-traumatic stress disorder (PTSD) in clinicians who treated survivors of the attacks. Knowledge gleaned from these new grants will help us address mental health consequences of future disasters and reduce suffering.
NIH also serves on HHS Secretary Tommy Thompson's recently established Council on Private Sector Initiatives to Improve Security, Safety, and Quality of Health Care. This Council was established to provide a fair, systematic and consistent system to handle requests from individuals and firms seeking review of their innovative ideas and products and to encourage strong collaborations between government and industry. NIH officials have met with a number of private sector individuals and companies about their ideas and products related to biodefense to provide technical assistance and to make them aware of funding opportunities. These are but a few ways in which the NIH continues to respond to the challenges and potential threats to the nation's citizenry.
Dr. Fauci will elaborate on NIH's biodefense research portfolio.
As you requested, I am also here to testify about NIH's collaborations with the private sector. These collaborations are particularly important today, for we stand on the threshold of the most exciting and promising era of biomedical research in history. Over the next decade, we can expect to see exponential growth in our understanding of human disease and ways of minimizing, and in some cases eliminating, human suffering from a variety of vexing diseases. Collaboration has never been more important to our success. Progress will depend on being able to assemble multidisciplinary teams of scientists, cross-cutting initiatives, and public-private partnerships.
NIH is actively pursuing research partnerships and collaborations across the world. And some of our most valuable partners are and will be right here in Montgomery County.
I want you to know about one example of these partnerships, which happens to involve biodefense research. On May 9, 2002, the NIAID announced the results of research that completed the genetic comparison of two important isolates of the anthrax bacterium: the well-known Ames strain and an isolate from the recent Florida anthrax attacks. The study was conducted by scientists at The Institute for Genomic Research (TIGR), based in Montgomery County, as well as researchers from Northern Arizona University. NIAID partnered with the Office of Naval Research, the National Science Foundation, and other agencies to fund the research. The study demonstrates how a new technology - whole-genome sequencing - and computational methods can successfully analyze anthrax and other bacterial outbreaks, both naturally-occurring and planned releases. These techniques will enable researchers to more accurately trace the origin of individual bacterial strains, determine if those strains have been genetically modified, and assess differences in their ability to cause disease or resist antibiotics.
To build on this research, the NIAID has awarded additional funding to TIGR, in collaboration with Northern Arizona University, for an expanded, comprehensive genomic analysis of at least 14 B. anthracis strains and closely related bacteria. This success is one of the early fruits of the six-year, $25 million contract NIAID entered into last year with TIGR to establish a functional genomics resource center. With NIAID support, scientists from TIGR and other institutions have already finished sequencing the DNA of many pathogens, including those that can cause tuberculosis, cholera, chlamydial infections and syphillis. The Pathogen Functional Genomics Resource Center at TIGR will continue to be a valuable central training and resource facility supporting research on pathogens.
Another local example of NIH partnerships with the private sector is the $58 million in awards to sequence the genome of the rat to Celera Genomics, located in Montgomery County, and Baylor School of Medicine, made jointly by the National Human Genome Research Institute (NHGRI), and the National Heart, Lung and Blood Institute (NHLBI) in 2001.
The rat genome sequence will further accelerate genomic-based research leading to improved understanding of how human genes work. The scientists involved in this project are using a strategy that combines elements of a hierarchical shotgun, or map-based approach, and a whole-genome-shotgun approach.
Data from the project will be released weekly into public databases at the National Center for Biotechnology Information. Scientists from TIGR are also collaborating in this effort.
Partnerships between NIH and the private sector often involve transfers of technologies from our intramural research laboratories to commercial companies for further research and development. Such transfers involve the creation of new therapeutic drugs and vaccines, diagnostics, and research resources to assist the research enterprise in developing new products to improve public health. The NIH is one of the premier biotechnology transfer operations in the world and generates approximately 70 percent of the royalty income from the entire Federal Government.
Of the nearly 1,500 currently active licenses the NIH administers, 77 are with firms in Montgomery County, Maryland. These firms include the following: GenVec, Inc., AlbaPharm, EntreMed, MedImmune, 20/20 Gene Systems, OmniViral Therapeutics, Genetic Therapy, Inc, RegeneRx Biopharmaceuticals, Veritas, Invitrogen, BioReliance Corporation, and Intracel Corp.
Currently, technologies developed in NIH laboratories are a part of over 200 products on the market, including 15 therapeutic drugs and vaccines. Two of those therapeutic drugs are produced and distributed by MedImmune, Inc., a firm headquartered in Montgomery County.
One of the drugs is Synagis, a monoclonal antibody used for the prevention and treatment of serious lower respiratory tract disease by respiratory syncytial virus (RSV). RSV is the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Synagis is the world's first monoclonal antibody licensed by the FDA for any infectious disease.
The other drug is NeuTrexin, a treatment used to treat infections in AIDS patients that do not respond well to standard therapy.
The NIH also has a number of public-private partnerships through the Cooperative Research and Development Agreement (CRADA) mechanism. The purpose of a CRADA is to make Government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products. Currently we have 274 active CRADA projects active at the NIH. Of those active CRADAs, 25 are with Maryland companies, including several with components located in Montgomery County: EntreMed, Novavax, Gene Logic, Human Genome Sciences and MedImmune, to name a few. Partnerships and mechanisms such as those I have mentioned also will prove useful in our efforts related to biodefense.
This concludes my statement, Madame Chairwoman. I will be pleased to answer any questions you may have.
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Last revised: June 26, 2002