Historical Precedents

Two prominent cases of accidental exposure to hazardous biological agents in the UK were due to lapses in bio-security in research laboratories. The first case in question occurred in 1978, a medical photographer, Janet Parker, died as a result of exposure to smallpox at the University of Birmingham Medical School. Prof Henry S. Bedson, who was in charge of the smallpox research program, committed suicide a month later. His note read, 'I am sorry to have misplaced the trust which so many of my friends have placed in me and my work.' Twelve years before, another medical photographer from the Anatomy Department had started a chain of infection extending to almost 50 people but no fatalities resulted due to it being caused by a weaker strain of the disease. After the global eradication of smallpox was certified in 1980, inoculation programs were no longer carried out and, as a result, people born after this period do not have immunity against it. Samples continued to held at various laboratories, the knowledge and technology even exists to bring the disease 'back to life' without recourse to organic samples.

In the second prominent case, a leak from the Institute of Animal Health in Pirbright, Surrey led to an outbreak of foot and mouth disease which has serious implications on food security and the system of livestock movement on which the agro-industry relies on to maintain reliable supplies. [Addendum: Also see a BBC news report on the release of the UK government's report on the Pirbright incident, PDF]

Data from the US is more sparse. Wenger notes tersely (and without supporting citation): 'Since 1980, five people have been killed by bioterrorism attacks - all in 2001 and all presumably involving anthrax spores from US military laboratories.' [3]

Golden Eggs Cooking Our Own Goose?

Internationally, life sciences research has been made great strides in many useful and worthy areas such as improving immunity to influenza or a universal flu vaccine; in Singapore, it has been cultivated as another engine of economic growth.

However the creation of a 'safe' Ebola virus for research reminds us that it is not only dual use but also dual direction. Adverse, dangerous changes can be unwitting, accidental, may not realize until it is too late. Such changes include:

1. Safer handling and deployment of still dangerous agents;
2. Easier propagation and/or distribution;
3. Improved ability to target the host;
4. Greater transmissivity, infectivity;
5. More difficulty in detection;
6. Greater toxicity, more difficulty in combating;
7. More (self-limiting, self-enhancing...) [4]

An alternative and overlapping list includes:

1. Experiments that would demonstrate how to render a vaccine ineffective;
2. Experiments that would confer resistance to therapeutically useful antibiotics or antiviral agents;
3. Experiments that would enhance the virulence of a pathogen or render a non-pathogen virulent;
4. Experiments that would increase the transmissibility of a pathogen;
5. Experiments that would alter the host range of a pathogen;
6. Experiments that would enable the evasion of diagnostic/detection modalities and
7. Experiments that would enable the weaponization of a biological agent or toxin. [5]

Given my extremely limited knowledge about the life sciences, I am unable to assess the risks, to public health in the event of a bio-safety breach, of, for example, SIgN research into the immunology of cancer, autoimmunity/immune deficiency, infectious disease immunology, system immunology or translational and clinical research (TCR).

Questions about Agencies and Structures

I know very very little about which agencies are the frontline/day-to-day regulators or who is ultimately responsible for ensuring that bio-safety regulations are adhered to - so this section parades my ignorance as well as my curiosity; it would be much appreciated if readers in the know could enlighten me - but without breaching any laws, rules and regulations or professional ethics please.

My guess is that the legal framework is provided, to some extent, by the Biological Agents and Toxins Act and one of the key agencies would be the Bio-Safety Branch, Operations Group, Ministry of Health HQ. Again, I do not know how much manpower and budgetary resources that the Bio-Safety Branch or any other regulator has been allocated.

Other questions relevant to the context of this post include: Does the Bio-Safety Branch or another agency maintain a registry of ongoing bio-science research programs? Or have input in vetting biotech R&D projects that A*Star brings in? Does it have the powers to conduct surprise mandatory inspections? If so, what has been the compliance rate? Or are researchers only subject to self-regulation according to a voluntary code of conduct which the MOH playing an advisory role? If there is a crisis, at what point does the issue get taken up outside of MOH jurisdiction to be subsumed under the National Security coordination structure or involvement of subject matter experts from other ministries such as the role played by the SAF's HQ Medical Corps during the SARS epidemic or the future possible involvement of the Chemical, Biological, Radiological, Explosives (CBRE) Defence Group in a non-terrorist incident?

Some Lines of Defence

While this post concentrates on highlighting possible risk, it is also mindful of Wenger's warning on the dangers of over-reaction, particularly in framing the debate solely in NAT's catastrophic failure terms. First, it may increase terrorist interest in acquiring such capability. Second, the expansion of biosecurity measures may increase inadvertent diffusion of knowledge and abilities that are required to undermine them. Third, obsession with worst case scenarios creates huge opportunity costs and the resulting securitization may impede legitimate internationally coordination and sharing of life science research. [6]

Nonetheless Wenger acknowledges that there is a need to manage the threat of bioterrorism more generally and for better institutional oversight and accountability in research labs and the private sector - the focus of this post being on the latter. I now turn to Kellman's more specific discussion of policy regarding codes of conduct, translucency, bio-scientists as the first line of defence.

Self-regulation and voluntary codes of conduct would be the most attractive from the point of view of researchers and corporations. It also creates less work for government agencies. However Kellman points out that the current situation with such codes have 'inherent structural flaws'. He argues that definitions of dangerous research needs to be globally uniform in the context of universal participation prevent a race to the bottom. The codes need to be legally enforceable with appropriate sanctions and verification mechanisms to ensure meaningful compliance. Using a wonderful dairy product analogy, Kellman argues that 'ethical declarations that lack capacity to internationally manage risks inevitably create something of a Swiss cheese of protections... From the prevention perspective, as science evolves, the presence of cheese in some places becomes less important than the holes in others.' [7] Will Singapore, once again, be able to act as a norm leader and entrepreneur in the drafting of a global code in the inspirational mold of Ambassador Tommy Koh and his team during the United Nations Convention on the Law of the Sea conference III?

Kellman also proposes a compromise between transparency (to compel accountability) and opacity (to protect proprietary and privacy interests) which he terms translucency. He differentiates between the fact versus the content of research, arguing that only the 'location and basic purpose not its methodology and results... should be disclosed' so that attention can be concentrated on ensuring adequate biosecurity measures are taken with respect to research with serious bioviolence risks.[8] Of course, implementing this on an worldwide, internationally coordinated and non-intrusive way will be a huge challenge but the principle looks sound from my layman perspective.

A key set of measures involves frontline practitioners - the bioscience researchers. Kellman advocates fostering strong ethical and safety awareness through institutional mechanisms in a highly competitive and pressuring field. Such mechanisms include as monitoring by research advisers and committees as well as ensuring that the highest standards in ethics and safety all the way from research design to publication of results; that they are an integral part of a rigorous research program and not a merely 'good to have'.

Another key mechanisms is professional certification along the lines of the professions of medicine and law. Kellman criticizes the US Student and Exchange Visitor Information System (SEVIS) and the FBI's Security Risk Assessment (SRA) initiative as poorly designed and even possibly counter-productive. It is argued that increased formal professionalization, with the coalescing of professional knowledge and norms, will help ward off clumsy, heavy-handed state intervention. With Singapore's great love affair of paper certification, this would not entail a huge cultural change.

However that might not be the case for the third and final recommendation. It is noted that scientists are the people who have the means and the motive to detect and report misconduct, faulty measures or procedures, near-misses and actual incidents. The US Commission on Research Integrity's recommendations on a Whisteblower's Bill of Rights [now established the Office of Research Integrity?] are cited in favour of measures that 'strengthen whistleblower protection by encouraging institutions to treat whistleblowers fairly, protect them from retaliation, and to articulate the responsibilities one incurs when accusing another of misconduct.' [9]

Conclusion

If scientists want to have a bigger say in running their own affairs rather than to have state agencies breathing down their necks all the time, then a substantial professional commitment, of professional responsibility - incorporating research ethics, certification and whistleblowing - needs to be put onto the agenda and implemented with the cooperation of the relevant stakeholders. A worst case scenario could be that scientists wait for the gahmen, the gahmen waits for international harmonization, only for a serious breach to take place in the meantime, leading to the imposition of heavyhanded wayang type action-action by the authorities in the wake of a hysterical moral panic, diminished support by the wider population and severe damage to Singapore's biotech hub ambitions.

References

[1] Todd LaPorte and Paula Consolinin, 'Working in Practice but Not in Theory: Theoretical Challenges of "High Reliability Organizations,"' Journal of Public Administration Research and Theory, Vol.1 No.1 (Jan 1991), 43.

[2] See, for example, Gregory Koblentz, 'Pathogens as Weapons: The International Security Implications of Biological Warfare', International Security, Vol.28 No.3 (Winter 2003-4), 84-122.

[3] Andreas Wenger, 'Securing Society Against the Risk of Bioterrorism' in Andreas Wenger and Reto Wollenmann (eds), Bioterrorism: Confronting a Complex Threat (Boulder, Colorado: Lynne Rienner, 2007), 208.

[4] Stephen M. Block, 'Living Nightmares: Biological Threats Enabled by Molecular Biology' in S.D. Drell, A.D. Sofaer, and G.D. Wilson (eds), The New Terror: Facing the Threat of Biological & Chemical Weapons, (Stanford, California: Hoover Institution Press: 1999), 46-7. [PDF]

[5] 'Research of Concern', National Research Council of the National Academies, Biotechnology Research in an Age of Terrorism (2004) cited in Barry Kellman, Bioviolence: Preventing Biological Terror and Crime, (Cambridge: Cambridge University Press, 2007), 138.

[6] Wenger, 209.

[7] Kellman, 140-2.

[8] Ibid, 142.

[9] Ibid, 146.