Copyright 2002 eMediaMillWorks, Inc.
(f/k/a Federal
Document Clearing House, Inc.)
Federal Document Clearing House
Congressional Testimony
February 5, 2002 Tuesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 3328 words
COMMITTEE:
SENATE COMMERCE, SCIENCE AND TRANSPORTATION
SUBCOMMITTEE: SCIENCE, TECHNOLOGY AND SPACE
HEADLINE: BIOTERRORISM PREPAREDNESS
TESTIMONY-BY: RICHARD KLAUSNER, M.D., SENIOR FELLOW AND
SPECIAL ADVISOR
AFFILIATION: FOR COUNTERTERRORISM
NATIONAL ACADEMY OF SCIENCES
BODY: Statement of
Richard Klausner, M.D. Senior Fellow and Special Advisor for Counterterrorism
National Academy of Sciences
Before the Committee on Commerce, Science
and Transportation U.S. Senate
February 5, 2002
Good Morning,
Mr., Chairman and members of the Committee. I am Dr. Richard Klausner, Senior
Fellow at the National Academy of Sciences and Special Advisor to the Presidents
for Counterterrorism. I am also Chair of the National Academies' Committee for
Science and Technology (S&T) Agenda for Countering
Terrorism. The Academies include the National Academy of
Sciences, the National Academy of Engineering, and the Institute of Medicine.
The National Academy of Sciences was chartered by Congress in 1863 to advise the
government on matters of science and technology. The National Research Council
(NRC), the operating arm of the Academies, was established in 1916. The National
Academy of Engineering was established in 1964. The Institute of Medicine was
established in 1970. These institutions provide independent advice on science
and technology and related policies for the federal government, including
executive and legislative branches. The National Academies began mobilizing the
S&T community to address the threats presented by
terrorism
immediately after the horrific events of September 11 th . It assembled a
distinguished group of scientists, engineers, health care professionals,
industrialists and former high level government officials on September 26 th to
develop a series of initiatives which the Presidents, themselves, could
immediately initiate from their own resources while government was mobilizing
its own activity. Among the suggestions emerging from that meeting which have
all now been initiated, were the following:
the development of an
S&T agenda for addressing the comprehensive range of vulnerabilities 1. our
country faces extending over the next decade and how S&T can best respond to
them; this work is being undertaken by a distinguished, eclectic committee which
I co-chair with Professor Lewis Branscomb of the Kennedy School at Harvard. This
work is being closely coordinated with the Office of Science and Technology
Policy (OSTP) and, through that office, with the Office of Home Land Security. I
shall provide some details of the committee's work subsequently;
near-term technical assistance to the government through real time
advice by scientific experts on topics panels chosen by the inter-agency
Technical Support Working Group (TSWG) and, separately, by the U.S. Postal
Service.
an intensification of international activities on both a
bilateral and multi-lateral basis through a variety of institutional mechanisms.
These include discussions with scientists in key countries on how to lessen the
risk of proliferation of weapons of mass destruction under the auspices of the
NAS Committee on International Safeguards and Arms Control. They also include
multi-lateral academy-academy discussions under the Inter Academy Panel and
Council and bilateral activities of a wide variety of sorts, including
discussions with national academies in Moslem countries.
Technical and
policy work on bioterrorism under the broader, on- going activity on infectious
diseases and vaccine policy, largely within the Institute of Medicine; Workshop
and studies on issues affecting universities arising out of
Terrorism Events. Issues include
student visa
and tracking policies and systems and the management of biological research
security in university laboratories.
In addition to the kinds of
specific initiatives enumerated above, there have been a number of
counter-
terrorism activities related underway under the
auspices of the more than 80 standing boards throughout the National Research
Council. Some of these are activities and and studies were begun considerably
before September 11 th , but they are even more timely because of the events of
that day.1 Others have been initiated since September 11 th in response to
agency requests.
I have attached a document, entitled "Summary of
Selected Counter-
Terrorism Initiatives by the National
Academies," dated December 18, 2001, which summarizes the comprehensive scope of
activities which have been initiated either by the Academy Presidents or by
standing committees throughout the National Academies complex.
I wish to
offer several perspectives on the role of science and technology as related to
bio-
terrorism, as an example of broader application, in the
time remaining. It is clear to me that we cannot solve the comprehensive and
daunting threat presented by bio-
terrorism without the active
and sustained effort of the science and technology community. Indeed, the
S&T community is ready and willing to respond. But how do we connect all the
relevant S&T communities with the many requirements
bio-
terrorism presents at both the national and local level?
One part of the approach is embodied in the comprehensive, S&T
visioning project for combating
terrorism I am co-chairing.
This project is aimed at helping the Federal Government, and more specifically,
the Executive Office of the President, to use effectively the nation's and the
world's scientific and technical community in a timely response to the threat of
catastrophic
terrorism. Under the sponsorship of the National
Academies , a distinguished assembly of scientists and engineers will help the
government develop a vision for how S&T can address the complex challenges
presented by
terrorism. The project will undertake the
following tasks to be presented in a report in six months: (1) prepare a
carefully delineated framework for the application of science and technology for
countering
terrorism, (2) develop a comprehensive threat-based
agenda by which S&T can address challenges presented by
terrorism to our security; (3) characterize cross-cutting
issues, and (4) address implementation hurdles with recommendations for
overcoming them. The S&T vision and agenda will be developed in the
following areas:
-Biological
-Chemical
-Nuclear and
Radiological
-Information technology
-Transportation
-Energy facilities, cities and fixed infrastructure
-Behavioral,
social and institutional issues
-Systems cross-cutting issues
We
believe the work of this committee will provide the an integrated science and
technology vision and program plan, extending over a decade, for combating
terrorism. We know of no similar activity underway anywhere
else. We believe it will be quite useful in helping the executive and
legislative branches in allocating resources against the comprehensive threats
presented by
terrorism.. After completion of our report in May,
I would be happy to return to present the report's key findings and
recommendations. Parallel activities are underway to help connect the relevant
S&T community with immediate technical requirements of federal and local
agencies. One is a project in which the Academies are inviting scientific
experts to meet with government representatives in one-day meetings to address
how better to address near term requirements of federal and local agencies.
Although no written reports are produced and no formal Academy advice is
provided, the dialogue is beneficial to federal agencies, including the 80
member, inter-agency Technical Support Working Group (TSWG) on
counter-
terrorism. In December, we invited scientific experts
to engage in dialogue with TSWG panels on bio/chemical forensics and
bio/chemical decontamination. Another meeting is planned next month on
through-structure imaging. Earlier, we met with U.S. Postal Service personnel to
assist the service in evaluating radiation technologies to sanitize contaminated
mail. Within the Institute of Medicine (IOM), a number of public health
strategies to address t terrorist threats have been undertaken. The goal of this
activity is to provide guidance on specific issues of national, local and
individual concern, within the framework of a comprehensive strategy to assure
the health of the public in the 21 st century. Projects include a comprehensive
bioterrorism threat assessment. This assessment was initiated within the Forum
on Emerging Infections. A November workshop, addressed "Biological Threats and
Terrorism: How Prepared Are We?"
Other
components of the IOM Strategy include communications, legal authorities, and
vaccine policy components. The adequacy of surveillance systems and laboratory
capacity are being addressed as well as the psychological consequences of
terrorism and the long-term mental health consequences of
asymmetric warfare. The IOM has already commenced the evaluation of the adequacy
of local public health agencies and organizations to address the new
bioterrorism threats with which they are confronted on top of the general
spectrum of naturally occurring infectious diseases.
Many agencies
throughout the government work with scientists within their respective domains.
But the task for the Office of Home Land Security is to cut across all these
domains and mobilize scientists for the new challenges presented by
terrorism and to connect scientists working in relevant
disciplines with the requirements presented by
counter-
terrorism over the long term.
We currently do
not have adequate processes and structures in place to carry out the necessary
connectivity not only among agencies but among the participants in the S&T
enterprise: sponsoring agencies, users (both federal and local), and the diffuse
research community that must be mobilized to address
terrorism.
There are three over-arching issues relating to bioterrorism that I
believe require focused attention.
The first issue is to determine the
ingredients necessary to mobilize all the relevant S&T communities to
address the range of threats presented by bioterrorism. These threats include
both the potential bio-terrorist weapons which exist today, e.g. smallpox,
anthrax, botulism, as well as genetically modified organisms that can be made
toxic and used as weapons. To engage the S&T communities fully will require
effective communication of government needs and priorities as well as a
sustained financial commitment by government to address these priorities. The
second issue is how do we solve specific bio-challenges, solutions to which may
span the "silos" of existing disciplines, agencies and sectors. We must develop
the necessary linkages between S&T, the private sector (a necessary partner
for technology development), and the government, which is the most significant
sources of resources for scientific research and development. We need to find
ways to make the necessary linkages across the "silos" that exist presently in
agencies, disciplines and sectors. Are the agencies funded in such a way today
that they have sufficient incentives to ensure that they do come together for
the purposes we now must urgently address across many agencies? Do government
agencies have the tools to encourage participation of and partnering with the
private sector? Can agencies mobilize communication and management strategies
that will engage creative solutions from needed
disciplines or across
existing disciplines? The third issue we must address is how the public and
private sectors may more effectively partner to address bio threats at all
stages of development: from research, through development, final product
introduction and market penetration and wide use. The "products" are varied.
They include drugs, vaccines, detectors and other items across the complete
spectrum of prevention, detection, response, recovery and attribution. We
realize that we need very large dose numbers of vaccines, anti-bacterials, anti-
virals and mocrobial agents to protect the public and limit the spread of
disease. Yet the "market," alone will not produce these in sufficient numbers
and at the quality needed. The government will have to ensure that promising
projects in priority areas can be shepherded through to a productive end point
and made available for use of the appropriate federal, state, county, local and
public levels. This will require a reassessment of management tools and
traditions as well as new infrastructure. As the Council of the Institute of
Medicine stated in its Statement on Vaccine Development, dated November 5, 2001:
The events following the tragedies of September 11,2001, have
reemphasized a serious defect in America's capacity to deal with biological
agents used in terrorist attacks. The capacity to develop, produce, and store
vaccines to deal with these agents are inadequate to meet the nation's needs. In
1993 the Institute of Medicine published The Children's Vaccine Initiative:
Achieving the Vision. In assessing the national and international situation, the
committee said, "because the private sector alone cannot sustain the costs and
risks associated with the development of most CVI vaccines, and because the
successful development of vaccines requires an integrated process, the committee
recommends that an entity, tentatively called the National Vaccine Authority
(NVA), be organized to advance the development, production, and procurement of
new and improved vaccines of limited commercial potential but of global public
health need."
In a 1992 report, Emerging Infections: Microbial threats
to Health in the United States, another IOM committee recommended the
development of an integrated management structure within the federal government
for acquiring vaccines, as well as a facility for developing and producing
vaccines with government support.
Evidence for the inability of the
private sector to meet the country's needs for vaccines has accumulated
substantially since the 1993 report. Fewer private companies are manufacturing
vaccines. Continually needed vaccines such as the tetanus and influenza vaccines
are in increasingly short supply. The availability of influenza vaccines has
been delayed over the past several years and in 2000, one company stopped
production. Pneumonococcal conjugate vaccine is unavailable in several states
because of the sole source manufacturer" inability to meet demands. Only one
source is currently available for meningococcal varicella and measles-mumps-
rubella vaccines.
There are just four major vaccine manufacturers in the
world today, and only two in the United States.4 There were four times that
number only 20 years ago. There are many small new research and development
companies backed by venture capital and devoted to vaccine development. Many are
working on anticancer vaccines for which market forces may be enough to keep
them in production. However, good products developed by these startups to combat
infectious diseases often do not come to market because of the very large costs
of testing in pilot studies and in manufacturing.
Prior to the events of
September 11, the delays and problems faced by both the Department of Health and
Human Services and Department of Defense in developing and procuring a
cell-culture smallpox vaccine provide convincing evidence that major changes are
needed at the national level. With the government guaranteeing payment in this
time of national need, several potential manufacturers have come forward. This
is an ad hoc example of a larger national need for mechanisms to obtain other
public-good vaccines on an ongoing basis, and not just under extenuating
circumstances when there is a great deal of public awareness of the need for
vaccines.
. . . The Children's Vaccine Initiative committee listed the
functions of a National Vaccine Authority. . . . They now have a broader
importance to America, as the potential need for vaccines required to meet
biological threats increases. The IOM Council believes the Authority should
focus its attention upon vaccines that will not be adequately produced by
existing public or private entities.
Recently, proposals have been made
for the creation of a government-owned, contractor-operated national vaccine
facility. The IOM Council believes this is one in a spectrum of public- private
ventures by which a NVA could facilitate development and production of needed
vaccines. . . . While a major priority for this facility would be to develop
vaccines necessary to protect American troops and for use against bioterrorism,
the facility also should be charged with production of other vaccines that are
in scarce supply and would not otherwise be provided in the public or private
sectors. In some cases in which there are few private sector uses, the facility
would become the principal source of such vaccines. In other cases, as variety
of public and private partnerships could be undertaken to produce needed
vaccines.5
The Council of the IOM believes that the development of a
National Vaccine Authority is long overdue. It could be created within the
Department of Health and Human Services, in collaboration with the Department of
Defense or as a joint effort of the two departments. Moreover, the Council
believes that establishment of a government-owned, contractor-operated facility
for research, development, and production of vaccines is essential to meeting
the country's public health needs, particularly those related to bioterrorism
and protection of our armed forces. . .
I believe there are three
actions that should be initiated with the encouragement of Congress: First, the
National Institutes of Health (NIH) needs to consider whether it needs to
establish an Advanced Research Projects Agency - perhaps modeled on the DARPA
model - to more effectively engage and harness critical creativity and better
link it to both local and federal requirements and accelerate the rate of
introduction of new technology into broad use. Secondly, the government should
implement The Institute of Medicine recommendation to establish a National
Vaccine Authority (NVA), charged with carrying out the functions spelled out in
the November 5 IOM Statement.
Thirdly, serious consideration should be
given to the establishment of new funding and management tools that encourage
and sustain public-private partnership. Lessons should be captured from
successful existing examples such as the efforts undertaken by NIAID and
expanded upon to meet current needs.
We clearly need a better national
approach for anti-toxin, anti- microbial drugs development, production and
storage. We are on the cusp of an explosion in genome development. In addition
to the benefits of such an evolution are great risks: there will be the
potential for many more drug "weapons." Markets, alone, will not drive this
development and production activity, yet partnership with the private sector is
essential for realizing the goal.
Underlying the effectiveness of all of
the recommendations is the need for complete and effective communication and
information exchange. This applies across federal, state and local agencies;
among the government, academia and industry; and across the silos of scientific,
engineering, and health care disciplines. Critical to this effort is the need to
develop ways to better access information and affect more rapid response
capability for use at both the national and local levels. Part of this challenge
is related to improved information management systems; another is to assuring
the existence of accurate and authoritative information sources; yet another to
addressing the need for better training, and better real-time linkages among
those public and private- sector institutions which share responsibilities and
capabilities to protect (and improve) the health of the public in the 21 st
century.
I have appreciated the opportunity to testify before the Senate
Committee on Commerce, Science, and Transportation today on the important issues
you have raised relating to Home Land Security against bioterrorism.
I
would be pleased now to answer any questions you may have and request my
complete statement and attachment be included in the record.
LOAD-DATE: February 5, 2002