 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
Creating the Department of Homeland Security: Consideration of the Administration's Proposal
Subcommittee on Oversight and Investigations
Dr. Gail Cassell
Mr. Chairman and members
of the Committee, thank you for the opportunity to participate in this hearing. Before sharing my views, some comments about my background
may be helpful. My name is Gail
Cassell. I am a microbiologist
currently serving as Vice President for Scientific Affairs and Distinguished
Research Scholar in Infectious Diseases, Eli Lilly and Company.
Prior to my arrival at Lilly five years ago, I was the Charles H.
McCauley Professor and Chairman of the Department of Microbiology of the
University of Alabama Schools of Medicine and Dentistry, Birmingham, Alabama.
My background is that of a research scientist in infectious diseases
working in laboratories of both industry and a research-intensive university as
well that of a Director of large training programs for pre- and postdoctoral
students in molecular genetics, virology, and immunology.
I have served on the Advisory Committee of the Director of the National
Institutes of Health (NIH) and on the Advisory Council of the National Institute
of Allergy and Infectious Diseases of the NIH and as Chair of the Board of
Scientific Councilor's of the National Centers for Disease Control and
Prevention (CDC). I am currently a
member of the Director's Advisory Committee of the CDC.
Over the years, I have participated in reviews of the biomedical research
programs (including bioweapons defense research) in the Department of Defense.
Of particular relevance to the discussions today, I have been actively
involved in issues related to biodefense for over the past decade, as a past
President of the American Society for Microbiology (ASM), Chair of the Public
and Scientific Affairs Board of the ASM and a member of ASM's Task Force on
Biological Weapons. I served as
Co-chair of the committee that reversed the decision to destroy the U.S. stocks
of smallpox and as a member of the Advisory Committee to establish the first
unit in the U.S. military to address a bioweapons attack on U.S. soil.
In addition, I continue to serve on a number of committees in the
National Academy of Sciences (NAS) dealing with bioweapons, including a Russian
research advisory committee. Most recently I served on the Bioweapons
Subcommittee of the NAS Committee on Science and Technology for Countering
Terrorism. The events of September
11, and the anthrax incidents which followed, have proven the vulnerability of
the United States to terrorism and the complexities of preparedness. The need to strengthen planning, coordination, implementation
and oversight of homeland security is obvious.
The establishment of a new federal Department of Homeland Security, at a
cabinet level, can potentially achieve greater efficiency, effectiveness and
accountability regarding many aspects of terrorism. However, there are unique characteristics of bioterrorism
that deserve special consideration and suggest the need to address them in a
manner differently from that proposed by the Administration's Bill.
These characteristics include: (1)
inadequacy of existing countermeasures and urgent requirement for interdisciplinary
research; (2) indistinguishable features of bioterrorism and naturally occurring
infectious diseases; and (3) the nature and extent of the bioterrorism threat
and the need to balance public safety and legitimate research in regulation and
oversight measures. 1.
Inadequacy of existing countermeasures and urgent
requirement for interdisciplinary research There
is no simple counter to bioterrorism, no "magic bullet."
Instead, development of an integrated set of strategies is required.
Such efforts must include preventing countries from acquiring bioweapons
in the first instance, dismantling existing programs and capabilities where
proliferation has already occurred, deterring the use of biological weapons,
and, ultimately, putting in place countermeasures that can rapidly detect and
effectively defend against such use. It
is the latter that requires special consideration with respect to the proposed
role of DHS. In
the long term, the only way to defend against bioterrorism is through a
combination of constant surveillance, accurate diagnostics to identify threats
as early as possible, and continuous innovation to provide high quality vaccines
and drugs that can be useful against any attacks that do occur.
Research related to bioterrorism is inextricably linked to that of
naturally occurring infectious agents and development of new antibiotics,
antivirals, diagnostics and vaccines. The
research and development of technologies for biodefense should be synergistic
and not duplicative. The
diversity of existing biological weapons and the ever-increasing possibilities
preclude simple therapeutic countermeasures to bioterrorism. Furthermore, response possibilities are limited even for known
threats. Although there are 13
viruses on the current select agent list, there is only one antiviral, which is
for smallpox and must be administered intravenously. There are no truly broad-spectrum antivirals, and only a
limited number of antivirals for routine pathogens like influenza, herpes,
hepatitis B, and HIV. The situation
is somewhat better but still worrisome with respect to antibiotics.
There has only been one new class of antibiotics developed in the past
three decades. The Russians are known to have constructed antibiotic resistant
bioweapons. In short, our
antibiotic armamentarium is limited, and there is growing concern about an
increase in resistance to existing antibiotics. It
seems clear that no public health response to bioterrorism is likely to prove
effective without addressing the overall problem of antimicrobial resistance and
the challenges of drug discovery and development.
Finally, the best deterrent against the use of a biological weapon of
mass destruction may be a constant stream of new, innovative antibiotics,
antivirals, and vaccines. Knowledge
of such commitment and successful developments would surely dissuade the efforts
of our enemies in such an arena. Development
of these countermeasures will depend on interdisciplinary research ranging from
basic research into the mechanisms by which the agents cause disease, how the
body responds, and how the agents are transmitted.
This new knowledge then must be used to develop innovative vaccines,
antibiotics, antivirals, and immunomodulators.
Equally important will be to benefit from knowledge gained in previous
failures in countermeasure development efforts. Given the long lead-time necessary for development of
vaccines and drugs (average 8-10 yrs), achieving timelines and goals are
critical. The
magnitude of the challenge to develop effective countermeasures is great.
Success will require involvement of the very best scientific, medical,
and pharmaceutical talent in government, academia, and the private sector.
Likewise, in order to achieve success in a timely manner, the United
States must be able to capitalize upon the expertise of and existing
infrastructure for product development that resides in the pharmaceutical
industry. Engaging the full
spectrum of private industry, i.e., from the smallest biotech to the largest
pharmaceutical companies, in the search for solutions to infectious diseases,
will not only greatly raise the chances of success, it can also significantly
lower the total cost to taxpayers, augmenting public appropriations with private
capital investment. Thus, it is
critical to recruit these organizations into the biodefense effort and assure
effective alignment between government, academia and industry. NIH/NIAID
is uniquely positioned to lead the effort.
The NIH recognizes that significant advances occur when they are often
unforeseen. These advances expand
the experimental possibilities and open new pathways for research. It must be recognized that not all research problems are
equally approachable no matter how urgent and important to public health.
Research and development of countermeasures will be a long-term endeavor.
There is always uncertainty about where the most valuable discoveries can
be made but NIH is best placed to identify scientific opportunities and
applications that are relevant to the most pressing issues that will yield
solutions. NIH/NIAID is unrivaled
in its track record of bringing together the brightest scientists and rigorous
peer review and oversight of funded research.
Indeed, many of the best investigators have already been funded by NIAID
and have recently made major advances in determining the mechanism of action of
the anthrax toxin and the molecular mechanism by which the Ebola virus induces
death. As evidenced by mechanisms
put in place early in the AIDS epidemic, NIAID has a positive track record of
working with the private sector from early phase discovery to clinical
development. They can quickly
mobilize the research community. Last
fall, the NIAID conducted a study to show that existing stocks of smallpox
vaccine could be diluted at least 5-fold to provide immediate protection to a
larger number of individuals should the need arise.
Within three months a comprehensive Biodefense Research Agenda was
developed with broad input from the scientific and medical communities,
including those from industry. Over
20 initiatives already have been launched to expedite biodefense research.
This impressive efficiency is in part based upon the synergy, which is
derived by driving the biodefense research in parallel with all other infectious
disease and immunology research. Separation
of these two efforts could result in failure due to missed
opportunities-failure to apply the latest technologies or knowledge gained
from the study of other infectious agents.
Therefore, I recommend that the Department of Health and Human Services (HHS)
continue to be responsible for the prioritization, direction, and conduct
of federal research efforts related to development of countermeasures for
bioterrorism. Although
the Administration's Bill recognizes the necessity that HHS conduct
the research and development programs related to infectious diseases, Section
303(a)(2) of the Bill provides that DHS, in consultation with HHS, shall
have final authority to establish the research and development program,
including the setting of priorities. The proposed transfer of program and funding authority in the
Administration's Bill gives ultimate control of research spending and
priorities to DHS, a non-scientific, non-public health based agency.
To create the appropriate scientific infrastructure in DHS would result
in loss of momentum and unpredictability of new and ongoing research programs
within HHS. There is no time to
"re-invent the wheel" rather we should capitalize on the solid
infrastructure that already exists in infectious disease research in this
country. It is not clear which activities by the DHS would duplicate, supplant,
or replace existing programs conducted by HHS and create increased and recurring
costs. One of the most critical
determinants of success in biodefense research will be support and oversight of
excellent science based upon peer review and merit.
As stated earlier, NIH/NIAID has an unparalleled track record of success
based upon merit review. In
summary, a scientific health agency, HHS, rather than the non-scientific,
non-public health DHS should have the principal authority for developing and
prioritizing scientific and health related programs.
The role of DHS should be to integrate threat analysis and vulnerability
assessments into the research agenda. This
could be accomplished by appointment of an Assistant Secretary that would have dual reporting to HHS and DHS and to work
closely with NIH/NIAID. The desired
outcome would be mutually agreed upon research priorities that address
threatening biological agents. 2.
Indistinguishable features of bioterrorism and naturally occurring
infectious diseases While
bioterrorism poses grave threats, the human race has been ravaged by infectious
diseases throughout its history. The
emergence of new infectious diseases (notably HIVAIDS) has decimated entire
societies, while infectious agents such as influenza can turn unexpectedly
virulent, e.g. the 1918 influenza pandemic killed tens of millions of people.
In this broader context of emergent and resurgent infectious disease, the
victims of a bioterrorist attack pose an indistinguishable set of public health
challenges from any number of foreseeable natural outbreaks.
Since well over 30 previously unknown infectious agents (including
several new hemorrhagic fever viruses and new highly virulent strains of
streptococci) have been identified since 1973, it is imperative that our public
health infrastructure and surveillance systems be structured to recognize both
naturally occurring and intentionally released infectious agents.
CDC should have this
responsibility. Section 505(a)(2)
of the Administration's Bill requires DHS to carry out these functions under
agreement with HHS. A separate
public health system for biodefense should not be created.
The primary duty and authority should remain with CDC, which has the
existing knowledge, experience, and expertise.
Again, an Assistant Secretary with dual reporting to HHS and DHS could
coordinate planning and development of programs and lend technical assistance.
Working closely with the CDC Director mutually agreed upon public health
priorities for bioterrorism preparedness and response could be achieved in an
efficient manner. 3.
The nature and extent of the bioterrorism threat and the need to balance
public safety and legitimate research in regulation and oversight measures Biological weapons have
varied characteristics. High
potency, substantial accessibility, and relatively easy delivery characterize
the most fearsome agents. Humans,
animals, and plants are potential targets for bioterrorism.
Many of these agents-bacteria, viruses, and toxins-occur naturally in
the environment. Thus the agents
and much of the technology required to produce them are available for civilian
or military use in many countries. Regulation
and oversight measures for work with infectious agents must be balanced so as
not to impede legitimate research, diagnosis, and treatment of these naturally
occurring infectious agents. I
recognize that there is public concern about pathogenic microorganisms being
used as biological weapons by nations or individuals.
As these concerns are addressed, however, I urge that there be careful
review of possible measures that might be taken to establish appropriate safety
and enforcement measures. The
response taken should be carefully weighed and it should be balanced to avoid
over regulation and intrusive schemes that could interfere with the flow of
research activities in academia and industry.
Any resulting harm to research could deprive society of the benefits of
research advances. Scientific research must not be discouraged by unreasonable
restrictions. To do so would not
serve the public interest. In reviewing the possible
risks and options for responses, we should consider emulating the process used
in overseeing recombinant DNA research. This
experience is an example of where a technical problem was recognized and a
balanced analysis and an appropriate mechanism were set in place for overseeing
activities. The NIH Recombinant DNA
Advisory Committee developed a rational approach to regulatory oversight of
recombinant DNA. The NIH Guidelines
were developed by a committee of experts and an oversight regime was designed
with an understanding of the issues and risks.
We should use the same model to construct a reasonable method that will
not impede research or result in unnecessary costs. Institutions must take a proactive role in assuring that
hazardous agents are brought into or shipped from their facilities and used in
compliance with applicable regulations. The
most effective approach to adequate oversight and record keeping is for
institutions to monitor possession, transfer and use of select agents.
Placing responsibility at the level of individual institutions for
compliance with Title II of HR 3448 will be the least inhibitory to research. It is important to
coordinate programs related to human, animal, and plant agents because some of
the threats for each are the same. Section
302(a) of the Administration's Bill transfers to DHS the select agent registration and enforcement programs of HHS.
However, it does not transfer the select agent registration and
enforcement programs of the
Department of Agriculture to the DHS. Subtitle C of the Public Health Security and Bioterrorism
Preparedness Act of 2002 mandated coordination of activities of HHS and the
Secretary of Agriculture regarding "overlap agents"-that is, agents that
appear on the separate lists prepared by HHS and Agriculture.
Title II of that legislation expands the current select registration
program to include mandatory registration of possession of select agents.
Mr. Chairman, the Energy and Commerce Committee is to be congratulated
for their role in this important legislation.
Indeed, integration of the select agent registration program will
undoubtedly result in a more efficient registration process thereby expediting
registration. Coordination among
agencies that have regulations for infectious substances is important. Better
compliance can be achieved if regulations are clear and coherent, streamlined
and integrated, based on real risks, and effectively communicated to individual
researchers. Emphasis must be
placed on education, guidance and dissemination of information to research
investigators, who must clearly understand their role and responsibilities. Institutional Biosafety Committees can be strengthened and
there should be qualifications and training for institutional biosafety
officers. Laboratory scientists and
safety managers in institutions must have input into the rule-making procedures
and work to assure that regulations are realistically applied with minimal
intrusiveness. The core elements of a
regulatory regime are already in place in 42 Code of Federal Regulations Part 72
and in the Biosafety and Microbiological and Biomedical Laboratories (BMBL)
Manual. Appendix F includes
guidelines for Laboratory Security and Emergency Response for Microbiological
and Biomedical Laboratories. Although
it is currently nonspecific, it is a reasonable basis for the development of
biosecurity requirements. It should
be possible for HHS to modify its current regulatory regime to govern
registration for possession and build on the BMBL guidance to provide for threat
and risk based regulations. Security
for select agents should be based upon risk levels.
HHS has the best
scientific and institutional knowledge to provide oversight of select agent
registration and to develop rational enforcement programs.
The scientific communities, both in universities and in the private
sector, are accustomed to self-regulation in use of radioactive materials,
chemicals, and infectious agents. This
service is provided by institutional Biosafety Offices.
Likewise, review of protocols and inspection and accreditation of
facilities are the norm for use of laboratory animals in research.
Again, implementation of regulations related to select agents is
reminiscent of the oversight put in place with the advent of recombinant DNA
technology. In short, once the
regulations have been established, implementation can be achieved through use of
a system modeled after Biosafety Office Programs already in existence.
I believe the program for
select agents should remain within HHS. To
transfer it to DHS will result in a delay to implementation, which could
considerably slow down implementation of the biodefense research agenda.
More importantly, housing it within DHS could result in undue tension
with the research community. For
example, it is unclear whether the regulations to be put in place within the
next 180 days will be changed taking on more of a criminal approach rather than
one based upon scientific knowledge and insights into the biomedical research
process utilizing infectious agents. The
Administration's Bill states that interim regulations will be put in place
thereby leaving freedom following the transfer of authority to DHS for other
regulations to be drafted. In summary, I support
Title II and its protections for the legitimate and critical performance of
research and diagnostic testing. Security
for biological facilities is different from security for nuclear and chemical
facilities and must take into account the unique aspects of work with biological
agents. Inappropriate policy
measures and regulations to prevent terrorists from acquiring pathogens could
have unintended consequences for research aimed at developing the very
countermeasures that could eventually remove agents from the select agent list.
There needs to be a careful balancing of public concern about safety and
security with the need to conduct legitimate research to protect the public.
Because of the enactment of HR 3448, which
again the Energy and Commerce Committee and this Subcommittee had direct
responsibility, the United States is in a leadership position with regard to the
establishment of reasonable controls on select agents.
However, we should not have a false sense of security since no other
country in the world has adopted similar legislation, which will be necessary.
Ultimately, successful oversight will depend upon the integrity of
the personnel who have access to select agents and on local institutional
commitment. Conclusion
Again, I appreciate having been given the opportunity to share my views and concerns with you. The inadequacy of our current public health infrastructure and existing biomedical defenses against a range of possible bioterrorist attacks has become clear. This inadequacy has, moreover, served to underscore the already well-documented need for better and more varied antimicrobials, vaccines, and other agents to detect, prevent or treat infectious diseases. One likely outcome from increased attention to bioterrorism threats will be the development of more comprehensive public health measures and countermeasures to threats posed by naturally occurring infectious diseases. I believe the recommendations I have made today provide the greatest chances for success.
|
|||||||||||
|
