1. Dual-Use: The Fink Report
Lecture No. 14

2. I. Outline The concept of dual-use The Fink Committee Report
Slides 2 - 6
The Fink Committee Report
Objective and structure of the report
Slides
Recommendations of the report
Slides
Experiments of concern
Slides
Notes: This lecture introduces the concept of ‘dual-use’ in a systematic manner making particular use of the influential Fink Committee report of the US National Academies.

3. 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.
Notes: For life scientists it really is very important that the possibility of this new form of dual-use is grasped. Only when they understand that their benignly-intended work could be misused for hostile purposes can they see the importance of considering their own obligations to help prevent such misuse. The concept is , however, used in complex ways as explained in the paper by Atlas and Dando, but we will stick here to the straightforward idea given in this slide.
Ref:
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), Available from

4. 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…”
Notes: Many commentators have pointed out that the life sciences are undergoing a fundamental revolution which will have profound impacts. This quotation is from an article published in the journal Newsweek which interestingly made a direct analogy between what happened in physics at the start of the 20th century with what is happening in the life sciences at the start of the 21st.

5. 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…”
Notes: Whilst welcoming the advances in the life sciences for the undoubted benefits they bring, other analysts have pointed out the potential for hostile misuse. This interesting example published in 2001 focused on the potential for misuse of our growing understanding of the bioregulatory chemicals of living organisms rather than having the usual focus on pathogens. It thus was an early example of a growing awareness of the much wider range of concerns that will be illustrated in later lectures.
Ref:
Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from

6. 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
Notes: Kagan’s paper details why these and other bioregulators have physiological actions that could be severely disrupted.
Ref:
Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from

7. 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
While there are limitations to the hostile misuse of such bioregulators, Kagan’s paper also makes clear that there are some important advantages for the attacker.

8. 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…”
Notes: The kind of concerns raised in the previous slides eventually lead to the US Nationa Academies setting up the ‘Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology’. The committee was chaired by Gerald Fink and its its influential report was published in It was the first national academies report to examine national security and the life sciences.

9. 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…”
Notes: The committee made it clear that there was a wide spectrum of potential misuse, but that it would concentrate on just two points: the risk that dangerous material might be stolen from laboratories and the risk that the results of research could be misused. It is the second of these risks that is the primary concern here, but the first should not be neglected either in considerations of biosecurity.

10. 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…”
Notes: It is clear from the outset of the report that it was intended to be read internationally - as this quotation from the Executive Summary makes very clear.

11. 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
Notes: The committee’s report covered both the scientific issues that are of primary concern in this and the following lectures but also the development of the regulation of the life sciences to help prevent misuse. Life scientists simply have to take the time to examine both of these aspects of the report. The problem of regulation becomes more prominent in the later lectures in this series.

12. 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.”
Notes: Recognizing that scientists cannot apply their specific knowledge to assist in the prevention of misuse until they have a grasp of the problem the report’s first recommendation is that education courses need to be developed.

13. 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.”
Notes: The committee took an incremental approach to regulation here by suggesting that a new oversight system should build on the well-known established system used to control recombinant DNA experimentation. We will look in more detail at the experiments of concern at the end of this set of lecture slides.

14. 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…”
Notes: Once again here the committee opted for an incremental approach.Many journals were moving in this direction and the committee argued that this form of self-governance was much preferable to government regulation.

15. 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.”
Notes: This was the most radical proposal that the committee put forward. It was accepted by the US government and a National Science Advisory Board for Biosecurity (not biodefense) was set up following the report. Almost all of the NSABB’s meetings are open to the public and proceedings are available on the web so that the Board’s work in meeting its mandate can be followed in some detail.
Ref:
Charter, Voting Member and Ex Officio Members of the NSABB is available from the following website.
National Institute of Health Office of Science Policy (2008) About NSABB. Available from

16. 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…”
Notes: The committee recommended a system of review at the institution where the work was to be carried out and to begin with it again opted for an incremental approach by specifying just seven classes of experimentation that should be subject to review. However, as we shall see in the next slide it was fully aware of the need to go beyond this set of experiment.

17. 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…”
Notes: The proposed oversight system was to apply to NIH funded work, but in this section of the conclusions it was also made clear that the committee expected more of life science in the US - for example in private companies - to eventually be incorporated.

18. 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.”

19. 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.”

20. 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.”

21. 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..”
Notes: The list of experiments of concern and the fact that they would already require a review by the institutional IBC again emphasies the careful incremental nature of the the recommendations made by the Fink Committee.

22. Sample Questions
1. What is the modern concept of “dual-use”? Give three examples of experiments that could be of dual-use 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?

23. 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), Available from
(Slide 3)
Silver, L. (2007) ‘Science: The Year of Miracles’, Newsweek, 15th October, pp Available from
(Slide 4)
Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from
(Slide 7)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

24. (Slide 8)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 9)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 10)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 11)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

25. (Slide 12)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 13)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 14)
National Institute of Health Office of Science Policy (2008) About NSABB. Available from
The Secretary of Health and Human Services (2008) Charter: National Science Advisory Board for Biosecurity, Washington, D. C. Available from
(Slide 15)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

26. (Slide 16)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 17)
(Slide 18)
(Slide 19)
National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from
(Slide 20)