Transcript Dual-Use: The Fink Report Lecture No. 14 I. Outline • The concept of dual-use • Slides 2 - 6 • The Fink Committee Report –

Dual-Use: The Fink Report
Lecture No. 14
I. Outline
• The concept of dual-use
• Slides 2 - 6
• The Fink Committee Report
– Objective and structure of the report
• Slides 7 - 10
– Recommendations of the report
• Slides 11 - 14
– Experiments of concern
• Slides 15 - 20
2. Dual-Use (i)
• Traditionally the concept of ‘dual-use’ described
technologies developed by the military that
came to have civil uses. The internet is an
example of a military technology which was used
in this way.
• Now, in regard to the life sciences, the concept
refers to materials, technologies and knowledge
developed for benign civil purposes that might
be misused by others for hostile purposes.
3 Dual-Use (ii)
• Newsweek 2007
– “…Just as physics shocked the world in the 20th
century, it is now clear that the life sciences will shake
up the world in the 21st. In a handful of years, your
doctor may be able to run a computer analysis of your
personal genome to get a detailed profile of your
health prospects….A new technology called RNA
interference may also allow your doctor to control how
your DNA is ‘expressed’, helping you circumvent
potential health risks…”
4. Dual-Use (iii)
• Bioregulators as instruments of terror
– “…Bioregulators are structurally diverse compounds
that are capable of regulating a wide range of
physiologic activities, such as bronchial and vascular
tone, muscle contraction, blood pressure, heart rate,
temperature, and immune responses. These
substances can be harmful, however, in large
concentrations or if modifications to them bring about
changes in the nature or duration of their action…”
5. Dual-Use (iv)
• Some examples of bioregulators that could be
misused
– Cytokines
• E.g. IL-1, IL-6
– Eicosanoids
• E.g. PGD2, LTC4
– Neurotransmitters and hormones
• E.g. Catecholamines, Neuropeptides, Insulin
– Plasma proteases
• Kallikrein, bradykinin
6. Dual-Use (v)
• Advantages of Bioregulators to attackers
– Readily available
– Clinical effects are nonspecific
– Rapid onset of action
– Not on standard list of threat agents
– No vaccines available
– Potential for widespread dissemination
7. The Fink Committee Report:
Objective/Structure (i)
• Biotechnology Research in an Age of Terrorism
– “Although the National Academies have had many
reports on national security, this is the first to deal
specifically with national security and the life
sciences….much has happened to justify an
examination of the life sciences in this contest - the
discovery of nations with clandestine research
programs dedicated to the creation of biological
weapons, the anthrax attacks of 2001, the rapid pace
of progress in biotechnology, and the accessibility of
these new technologies…”
8. The Fink Committee Report:
Objective/Structure (ii)
• The committee’s view of the dual-use problem
– “…Our committee addressed one important part of
this spectrum…of possible misuse: the capacity for
advanced biological research activities to cause
disruption or harm.... Broadly stated, that capacity
consists of two elements:
• (1) the risk that dangerous agents that are the subject of
research are stolen or diverted for malevolent purposes; and
(2) the risk that the research results,knowledge, or
techniques could facilitate the creation of ‘novel’ pathogens
with unique properties or create entirely new classes of threat
agents…”
9. The Fink Committee Report:
Objective/Structure (iii)
• The international dimension
– “Although the focus of the report is on the
United States, this country is only one of
many pursuing biotechnology research at the
highest level….It is entirely appropriate for the
United States to develop a system to provide
oversight of research activities domestically,
but the effort will ultimately afford little
protection if not adopted internationally…”
10.The Fink Committee Report:
Objective/Structure (iv)
• The Structure of the report:
– 1. Introduction
– 2. The evolving regulatory environment for life
sciences research in the 21st century
– 3. Information restrictions and control regimes
– 4. Conclusions and recommendations
11. The Fink Committee Report:
Recommendations (i)
• Recommendations of the report
– “1. Educating the Scientific Community
• We recommend that national and international
professional societies and related organizations
and institutions create programs to educate
scientists about the nature of the dual-use dilemma
in biotechnology and their responsibilities to
mitigate its risks.”
12. The Fink Committee Report:
Recommendations (ii)
• “2. Review of Plans for Experiments
– We recommend that the Department of Health and
Human Services (DHHS) augment the already
established system of review of experiments involving
recombinant DNA conducted by the National
Institutes of Health to create a review system for
seven classes of experiments (the Experiments of
Concern) involving microbial agents that raise
concerns about their potential for misuse.”
13. The Fink Committee Report:
Recommendations (iii)
• 3. Review at the Publication Stage
– “We recommend relying on self-governance
by scientists and scientific journals to review
publications for their potential national
security risks.
• ….publication of research results provides the
vehicle for the widest dissemination, including to
those who would misuse them. It is thus
appropriate to consider what sort of review
procedures can be put in place at the stage of
publication to provide another layer of
protection…”
14. The Fink Committee Report:
Recommendations (iv)
• “4. Creation of a National Science
Advisory Board for Biodefense
– We recommend that the Department of Health
and Human Services create a National
Science Advisory Board for Biodefense
(NSABB) to provide advice, guidance and
leadership for the system of review and
oversight we are proposing.”
15. The Fink Committee Report:
Experiments of concern (i)
• “The committee identified seven classes of
experiments that it believes illustrate the
types of endeavors or discoveries that will
require review and discussion by informed
members of the scientific and medical
community before they are undertaken or,
if carried out, before they are published in
full detail…”
16. The Fink Committee Report:
Experiments of concern (ii)
• “The seven areas of concern listed here
only address potential microbial
threats….Over time, however, the
Committee believes that it will be
necessary…to expand the areas of
concern to cover a significantly wider
range of potential threats to humans,
animals or crops…”
17. The Fink Committee Report:
Experiments of concern (iii)
• Experiments of concern would be those that
– 1. Would demonstrate how to render a vaccine
ineffective. This would apply to both human and
animal vaccines.
– 2. Would confer resistance to therapeutically useful
antibiotics or antiviral agents. This would apply to
therapeutic agents that are used to control disease
agents in humans, animals or crops. Introduction of
ciprofloxacin resistance in Bacillus anthracis would
fall into this class.”
18. The Fink Committee Report:
Experiments of concern (iv)
• “3. Would enhance the virulence of a pathogen
or render a nonpathogen virulent. This would
apply to plant, animal and human pathogens.
Introduction of cereolysin toxin gene into Bacillus
anthracis would fall into this class.
• 4. Would increase the transmissibility of a
pathogen. This would include enhancing
transmission within or between species. Altering
vector competence to enhance disease
transmission would fall into this class.”
19. The Fink Committee Report:
Experiments of concern (v)
• “5. Would alter the host range of a pathogen.
This would include making nonzoonotics into
zoonotic agents. Altering the tropism of viruses
would fit into this class.
• 6. Would enable the evasion of
diagnostic/detection modalities. This could
include microencapsulation to avoid antibody
based detection and/or the alteration of gene
sequences to aviod detection by established
molecular methods.”
20. The Fink Committee Report:
Experiments of concern (vi)
• “7. Would enable the weaponization of a
biological agent or toxin. This would include
environmental stabilization of pathogens.”
• The report notes that
– “All of the experiments that fall within the seven areas
of concern should currently require review by an
Institutional Biosafety Committee (IBC)…We thus
recommend relying on the system of IBCs as the first
review tier for experiments of concern..”
Sample Questions
1. What is the modern concept of “dual-use”? Give
three examples of experiments that could be of dualuse concern.
2. Do you think that advances in the life sciences are
likely to increase the number and types of
experiments of dual-use concern?
3. Outline the structure of the Fink Committee’s Report.
What do you think were the most important
recommendations?
4. Discuss the seven classes of experiments that the
Fink Committee singled out for particular attention.
Do these cover all the types of experiment of
potential concern?
References
(Slide 2)
Atlas, R. M. and Dando, M. R. (2006) The Dual-Use Dilemma for the Life
Sciences: Perspectives, Conundrums, and Global Solutions. Biosecurity
and Bioterrorism, 4 (3), 276- 286. Available from
http://www.liebertonline.com/bsp?cookieSet=1
(Slide 3)
Silver, L. (2007) ‘Science: The Year of Miracles’, Newsweek, 15th October, pp.
40 - 49. Available from
http://www.brad.ac.uk/acad/sbtwc/test/italy/lecture14files/LeeSilver/LeeSilv
er.htm
(Slide 4)
Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory
Medicine, 22(3), pp. 607 - 618. Available from
http://www.labmed.theclinics.com/
(Slide 7)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=R7
(Slide 8)
National Research Council (2004) Biotechnology Research in an Age
of Terrorism. Washington: National Academies Press. Available
from
http://books.nap.edu/openbook.php?record_id=10827&page=1
(Slide 9)
National Research Council (2004) Biotechnology Research in an Age
of Terrorism. Washington: National Academies Press. Available
from
http://books.nap.edu/openbook.php?record_id=10827&page=2
(Slide 10)
National Research Council (2004) Biotechnology Research in an Age
of Terrorism. Washington: National Academies Press. Available
from
http://books.nap.edu/openbook.php?record_id=10827&page=15
(Slide 11)
National Research Council (2004) Biotechnology Research in an Age
of Terrorism. Washington: National Academies Press. Available
from
http://books.nap.edu/openbook.php?record_id=10827&page=107
(Slide 12)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=5
(Slide 13)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=116
(Slide 14)
National Institute of Health Office of Science Policy (2008) About NSABB.
Available from
http://oba.od.nih.gov/biosecurity/about_nsabb.html#xxPAGETOP
The Secretary of Health and Human Services (2008) Charter: National
Science Advisory Board for Biosecurity, Washington, D. C. Available
from
http://oba.od.nih.gov/biosecurity/PDF/NSABB_Charter_508_accessible
.pdf
(Slide 15)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=107
(Slide 16)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=114
(Slide 17)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=114
(Slide 18)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=114
(Slide 19)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=115
(Slide 20)
National Research Council (2004) Biotechnology Research in an Age of
Terrorism. Washington: National Academies Press. Available from
http://books.nap.edu/openbook.php?record_id=10827&page=115