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News from the National Academies

Date: Jan. 22, 2004
Contacts: Christine Stencel, Media Relations Officer
Heather McDonald, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <news@nas.edu>

FOR IMMEDIATE RELEASE

Congress Should Authorize New DOD Agency
To Develop Vaccines, Drugs Against Biowarfare Agents

WASHINGTON -- Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense, if drugs, vaccines, and other medical interventions against biowarfare agents are to be developed successfully, says a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies. DOD's existing medical biodefense activities, currently carried out by several units in the department, should be transferred along with their funding and personnel to a new Medical Biodefense Agency. If DOD fails to make sufficient progress toward an effective program for developing medical countermeasures within three years, then that responsibility should be partially or completely transferred out of DOD, added the committee that wrote the report.

"Despite congressional and White House declarations that biological warfare poses a significant threat to the safety and effectiveness of the nation's armed forces, DOD's efforts to develop the necessary medical products to protect troops can only be described as fragmented, unsuccessful half-measures," said committee chair Leslie Benet, professor of biopharmaceutical sciences, University of California, San Francisco. "DOD has acquired no new vaccines since the first Gulf War in 1990. If having the necessary countermeasures against biowarfare is indeed a serious national concern, then the only way to remedy this situation is to make the development of biodefense products a priority by pulling together all of the disparate efforts in one new agency at a sufficiently high level."

The lack of success resulting from several previous attempts to reorganize the medical biodefense programs in DOD contributed to the committee's conclusion that the creation of a new agency is the best solution. Among the programs that should be pulled together under the umbrella of the Medical Biodefense Agency are the medical biodefense components of the Chemical and Biological Defense Program, including some activities of the U.S. Army Medical Research Institute of Infectious Diseases, and some biodefense activities of the Defense Advanced Research Projects Agency. Furthermore, because efforts to develop drugs and vaccines against naturally occurring pathogens and biowarfare agents overlap, DOD programs focused on countermeasures against infectious diseases also should be transferred into the new agency.

While the Medical Biodefense Agency would be built largely from existing personnel and resources, new expertise and funding are needed, the report notes. The director of the agency should have a strong background in vaccine and drug research, development, and manufacturing, and additional personnel with such experience should be recruited. Based on the funding currently allocated to existing activities, the Medical Biodefense Agency would start with a baseline budget of $322 million. The committee did not consider this an adequate amount for the task, but said that DOD's efforts should be better focused before any substantial funding increases occur. The agency should receive an initial increase of $100 million, rising to $300 million above the baseline budget by the end of the first five years.

Congress should establish an external review committee made up of experts in the development of drugs and vaccines to evaluate annually the new agency's performance. If the review committee finds that DOD has failed to make sufficient progress within three years, then as a last resort, all or part of the medical countermeasures program should be transferred out of DOD. The National Institutes of Health currently appears to be the best alternative to take on this responsibility, although the committee noted that it is not ideal because it has many competing priorities, little tradition of product development, and a focus on civilian rather than military issues.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. To minimize redundancies and take advantage of new knowledge gained through these efforts, the Medical Biodefense Agency should coordinate its activities with NIH. However, because protecting troops in the field and ensuring their continued capacity to operate may require different research priorities and products, the agency should keep its efforts focused on meeting unique DOD needs.

Effective partnerships with academia and industry will be necessary to develop new drugs and vaccines, the committee noted. Congress should improve liability protection for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. The report also identifies other challenges -- such as the need for appropriate animal models and laboratories equipped with high-level biosafety protections -- that will require attention if DOD efforts to develop new medical countermeasures are to be successful.

The congressionally mandated report was sponsored by the U.S. Department of Defense. The Institute of Medicine and the National Research Council are private, nonprofit institutions that provide science and health policy advice under a congressional charter. The Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. A committee roster follows.

Pre-publication copies of Giving Full Measure to Countermeasures: Addressing Problems in the DOD Program to Develop Medical Countermeasures Against Biological Warfare Agents are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

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INSTITUTE OF MEDICINE
Medical Follow-Up Agency
and
NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies

Committee on Accelerating the Research, Development, and Acquisition of
Medical Countermeasures Against Biological Warfare Agents

Leslie Z. Benet, Ph.D. (chair)
Professor
Department of Biopharmaceutical Sciences
School of Pharmacy
University of California
San Francisco

Walter E. Brandt, Ph.D.
Senior Program Officer
Malaria Vaccine Initiative
Program for Appropriate Technology in Health
Rockville, Md.

Barry S. Coller, M.D.
David Rockefeller Professor of Medicine;
Head, Laboratory of Blood and Vascular Biology; and
Vice President for Medical Affairs
Rockefeller University
New York City

Glenna M. Crooks, Ph.D.
President
Strategic Health Policy International Inc.
Ft. Washington, Pa.

R. Gordon Douglas Jr., M.D.
Scientific Consultant
Niantic, Conn.

Jacques S. Gansler, Ph.D.
Professor, and
Roger C. Lipitz Chair
Center for Public Policy and Private Enterprise
School of Public Affairs
University of Maryland
College Park

Anthony L. Itteilag
Consultant
Silver Spring, Md.

Dennis L. Kasper, M.D.
Executive Dean for Academic Programs,
William Ellery Channing Professor of Medicine, and
Professor of Microbiology and Molecular Genetics
Harvard Medical School
Boston

Steven J. Kelman, Ph.D.
Albert J. Weatherhead III and Richard W. Weatherhead Professor of Public Management
John F. Kennedy School of Government
Harvard University
Cambridge, Mass.

Richard F. Kingham, J.D.
Partner
Covington and Burling
Washington, D.C.

Peter Palese, Ph.D.
Professor and Chair
Department of Microbiology
Mount Sinai School of Medicine
New York City

Paul D. Parkman, M.D.
President
Parkman Associates
Kensington, Md.

Ronald J. Saldarini, Ph.D.
Scientific Consultant
Mahwah, N.J.

Jane E. Sisk, Ph.D.
Professor
Department of Health Policy
Mount Sinai School of Medicine
New York City

Elaine Tuomanen, M.D.
Professor and Chair
Department of Infectious Diseases
St. Jude Children's Research Hospital
Memphis, Tenn.

Benjamin J. Weigler, D.V.M., Ph.D
Director
Animal Health Resources
Fred Hutchinson Cancer Research Center
Seattle

Janet Westpheling, Ph.D.
Associate Professor
Department of Genetics
University of Georgia
Athens

INSTITUTE STAFF

Lois M. Joellenbeck, Dr.P.H.
Study Director