Dual Use and Biosecurity: the Case of the Avian Flu H5N1

doi:10.4236/ojapps.2012.23017

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Open Journal of Applied Sciences, 2012, 2, 123-127

doi:10.4236/ojapps.2012.23017 Published Online September 2012 (http :/ /www.SciRP.org/journal/ojapps)

Dual Use and Biosecurity: The Case of the Avian Flu H5N1*

Pieter J. D. Drenth1,2

1Department of Psychology, VU University Amsterdam, Amsterdam, The Netherlands

2Royal Netherlands Academy of Arts and Sciences, Amster dam, The Netherlands

Email: [email protected]

Received June 25, 2012; revised July 24, 2012; accepted August 1, 2012

ABSTRACT

The classical dual use problem—the potential for harmful as well as beneficial application of scientific findings—has

become more immediate in biotechnology than in most other fields of science. Terrorist misuse of the information on

the development of pathogenic organisms can lead to catastrophic outcomes. Therefore, particular in biosciences re-

searchers are faced with the dilemma to find a proper balance between the right to know and the dangers of knowing. In

this paper this dilemma is illustrated by the research on th e influenza A virus subtype H5N1, commonly known as “b ird

flu”. The pros and cons of the full publication on the development of a dangerous airborne type are discussed.

Keywords: Dual Use; Biosecurity; Biosafety; Bird Flu

1. Introduction

The dual use problem—the potential for harmful as well

as beneficial applications of ideas, findings, discoveries,

tools and instruments—has been with us since the early

days of evolution. A stick could be used to rake bananas

beyond reach or to beat a congener, iron could be melted

to forge ploughshares or swords.

This applies to science as well. Scientific knowledge

can also be used for the better or for the worse. Nuclear

fission can be utilised for the production of clean energy

or for the development of an atomic bomb. The analysis

of pain can be applied for the development of effective

sedatives or of torturing interrogation means. Audiomet-

ric research can result in improved communication for

people hard of hearing or in criminal telephone tapping.

The scientific world has always been reluctant to ac-

cept constraints on research and to admit “no go” deci-

sions for certain subjects or fields of investigation. In the

first place because in principle nearly all results of scien-

tific research are open for wilful abuse. Prohibition of

scientific research for the fact that its results could be

abused or irresponsibly applied would, therefore, mean

the end of almost all research. Secondly, because unde-

sirable or dangerous consequences of research are not

always easy to chart, especially in fundamental or inno-

vative research with its creativity and serendipity. In the

third place because the arguments “undesirable” and

“dangerous” have too often been led to repression by

dictators, governments, political authorities, economic spon-

sors or popular action movements (environment, feminism,

anti-discrimination). One only has to remember Galileo,

Spinoza, More or in modern times Lysenko and Sacharov

to realize how innovative scientists and scholars can be

victimised if their results do not find favour with the rulers

in power.

It should be realised that, if there is a question of con-

straints on science, it is the scientific world itself that

should impose such restrictions. Legislation and bureau-

cratic regulations would be largely ineffective. Of course,

there are cases for which “no go” decisions would be

considered incontestable by all scientists and scholars.

For instance, cases in which unacceptable harm or dam-

age is inflicted upon the object of research (human be-

ings, animals, nature, cultural products), or cases in

which the nature or consequences of the research would

be in conflict with basic human values (human rights,

human dignity, equality, and non-discrimination (for a

more extensive discussion see Drenth, [1]). But, as said,

there is a strong disinclination to interdict research be-

cause of its potential misuse, and to go beyond the fos-

tering of scientists’ responsibility through training and

awareness programmes, and through the development of

codes and professional standards.

2. Biosecurity

Recently, however, this state of affairs underwent a change.

Incited by two deterrent incidents, the attack with nerve

gas in a Japanese metro in the mid 90’s, and the distribu-

tion of anthrax letters in the USA shortly after the 9 - 11

*This paper is based on a presentation at the General Meeting of the

International Human Rights Network of Academies and Scholarly

Societies in Taipei, Taiwan, on May 23-25 , 2012.

P. J. D. DRENTH

124

raid, one realised that abuse of biological research could

assume enormous proportions.

What types of potential misuse can be distinguished?

The US National Research Council [2,3] mentions seven

classes of experiments that raise concerns about their

potential for misuse, including those that would:

– Demonstrate how to render a human or animal vac-

cine ineffective;

– Provide pathogens with resistance to therapeutically

useful antibio tics or antiviral agents;

– Enhance the virulence of a pathogen or render a non-

pathogen virulent ;

– Increase transmissibility of a pathogen;

– Alter the host range of a pathogen;

– Enable the evasion of diagn osis or detection;

– Enable the weaponisation of a biological agent or

toxin.

Already in 1972 a “Biological and Toxin Weapons Con-

vention” had been signed by a great number of states (by

the year 2000 some 144 states plus 18 signatory states).

Article 1 of the BWC reads: “Each state party to this

Convention undertakes never in any circumstances to

develop, produce, stockpile or otherw ise acquire or retain

microbial or other biological agents, or toxins whatever

their origin or method of production, of types and in

quantities that have no justification for prophylactic,

protective or other peaceful purposes”. But terrorists

make light of such conventions and the threat of massive

harm may not be at all unrealistic. And it may be a mis-

take to think of terrorists as just loners working in their

garage wit h bombs and kalashni kovs.

On 7 November 2007 the international panel IAP (a

global network of science academies [4]) issued a state-

ment on biosecurity, representing fundamental biosecu-

rity issues that should be taken into account when for-

mulating codes of conduct. These include:

– Awareness: Scientists should always bear in mind the

potential (harmful) consequences of their research,

and refuse to undertake r e search that has only harmful

consequences for humankind;

– Safety and security: Good, safe and secure laboratory

procedures;

– Education and information on national and interna-

tional laws and regulations, as well as policies and

principles aimed at preventing misuse of biological

research;

– Accountability: Scientists aware of violations of the

BWC should raise concerns with appropriate people,

authorities and ag encies;

– Oversight: Scientists with responsibility for oversight

of research or evaluation of projects should adhere to

these principles.

This statement was supported by 67 national Acad-

emies of Sciences plus TWAS (the Academy of Sciences

for the Developing World). As can be seen, this state-

ment strongly emphasises the responsibility of the scien-

tists themselves.

The Royal Netherlands’ Academy of Arts and Sci-

ences (KNAW), that has been an active contributo r to the

IAP Statement, produced a “Code of Conduct for Biose-

curity” also in 2007 [5]. In addition to issues mentioned

above this code also includes rules of conduct on:

– Research and Publication policy: Be aware of and

screen for dual-use aspects during the execution of

research, and reduce the risk of potential misuse of

published results;

– Internal and external communication: Maintain ap-

propriate security for e-mails, post, telephone calls

and data storage concerning information about poten-

tial dual-use research or materials;

– Accessibility: Screening with attention to biosecurity

aspects of staff and visitors;

– Shipment and transport: Screening on biosecurity

aspects of transporters and recipients of potential dual-

use materials.

It may be good to point out the difference between

biosafety and biosecurity. The former concept deals with

the danger that a dangerous virus or pathogen escapes the

laboratory or repository or that someone at the laboratory

may have an accident, and the precautionary measures

that researchers have to take to avoid this risk. The latter

concept refers to the risk of wilful abuse of research in

the hands of a nefarious terrorist, and is more specifically

the subject of this paper.

A pressing question, then, is how to regulate the bio-

logical research in view of this threat of malignant use.

Many scientists, including the majority of respondents in

a survey of AAAS and the US National Research Council

[6], hold the view that scientists themselves should

shoulder this responsibility. They favour self-governance,

through creating awareness and responsibility, through

enlighten ed leadership (Franz [7]), by cultivating a moral

agency of individual scientists or groups of scientists

(Davis [8]), by enunciating norms and codes (Epstein

[9]), through educating junior scientists about dual use

(Sta.Ana, Frankel and Berger [10]), and through over-

sight mechanisms for research proposals and public-

cations in which peer reviewers try to answer the ques-

tion whether the scientific value of the (to be) gained

knowledge outweighs the risks of malignant abuse. On

the other hand it is also defended that the threat of misuse

does not stem primarily from within the scientific com-

munity, but from terrorists who have gained access to the

scientific knowledge and do not share the scientists’

moral imperative. It is then concluded that a national

government should assume the responsibility and should

take action through legislation and control. The US has

taken a step in the latter direction by founding a National

P. J. D. DRENTH 125

Science Advisory Board for Biosecurity (NSABB), an

independent committee that advises the US Department

of Health and Human Services and other federal agencies

on (the publication of) biological research that may en-

danger biosecurity. Although many of the recommenda-

tions of the NSABB tend to stress the importance of

self-governance and own responsibility of scientists, it

opens the opportunity for a governmental regulation or

action.

It will be clear that, next to the question whether such

a governmental control could ever be feasible and effec-

tive (and Epstein [9]) shows with good arguments that it

is not), we are also confronted with the more fundamen-

tal questions of freedom of research and inquiry, freedom

of speech and publication, and the balance between the

right to know and the dangers of knowing. Many scien-

tists feel that even well intended efforts to restrict the

freedom to share and to publish their research findings

may have serious consequences, both in terms of lost

knowledge and wrong app lication of existing kno wledge.

A good deal of this discussion can be illustrated on the

basis of a recent case at the Medical Faculty of the

Erasmus university in Rotterdam, where Ron Fouchier

and his colleagues modified the avian flu H5N1 to be

transmissible via aerosols or respiratory droplets, and

submitted a publication on this experiment to Science.

We will discuss some details of this case in the remain-

der of this paper1.

3. The H5N1 Avian Flu Case

3.1. The Facts

For quite some time a group of virologists at the De-

partment of Virology, Erasmus Medical Center in Rot-

terdam, led by Ron Fouchier, has researched the Influ-

enza A virus subtype H5N1, more commonly known as

“bird flu”. Since its first detection in 1997 this highly

pathogenic virus h as killed hundreds of millions of b irds,

but so far the virus caused only 577 (laboratory con-

firmed) cases of human infections, and only in people

who had been in close contact with infected poultry.

Sustained human-to-human transmission has not been

reported (Fouchier, Herfst & Osterhaus [11]). It is, how-

ever, a fairly lethal virus in people, having killed, ac-

cording to some estimates, around 60% of those 577 in-

fected individuals. And if this virus were to mutate to an

airborne type, which could be transmitted through

coughs and sneezes or via aerosols, a devastating pan-

demic must be expected.

Yet this is what Ron Fouchier and his assistant Sander

Herfst discovered. Through five mutations they modified

the virus into an airborne, and thus extremely contagious,

version. The research was done in ferrets, which catch flu

somewhat similar to the way humans do, and which are

considered the best models for such a test. The virology

group at the Erasmus University had asked and received

permission as well as funding to do this cutting-edge

research. They have followed carefully the rules of con-

duct prescribed in the IAP Statement and the KNAW

Code of Conduct for Biosecurity. Fouchier described his

work and data at the influenza conference organised by

the European Scientific Working Group on Influenza

(ESWI) in Malta in September 2011, and submitted a

manuscript with the full information for publication in

Science. The Science editors first conducted their own

biosecurity review (in agreement with the IAP statement

and the Dutch Code of Conduct for Biosecurity), and

sent it also to the NSABB for advice. The NSABB rec-

ommended to the US government that the conclusions of

the manuscript could be published, but without experi-

mental details and mutation data that would enable rep-

lication of the experiments. NSABB further recognised

that detailed information about the results should be

shared under confidentiality with parties that “need to

know” (Fouch ier, Herfst & Osterhaus, [11, p.2]).

In the meantime it has become a notorious case. It was

subject of an often heated debate in the scientific press,

but also in the public media, especially after the publica-

tion of an article “Debate persists on deadly flu made

airborne” in the Science section of the New York Times

on December 26, 2011, and the large number of com-

ments that it provoked. Critics charge Fouchier and his

group with the accusation that he should not have created

the virus in the first place, and insist that this research

should not be publish ed .

The authors do not agree with the NSABB recom-

mendations, but respect nevertheless their advice. They

were willing to submit an article version that does not

include the methodological and other details that could

enable replication of th e experiments by criminals, and to

try to find a solution for disseminating key information to

those who need to know. In a statement in Nature and

Science by the end of January 2012 all 39 influenza re-

searchers who work at virology laboratories where such

experiments could be carried out endorsed a 2 months

moratorium on studies that make the avian influenza

strain H5N1 more transmissible between mammals, in

order to make time for an international debate on its bio-

security consequences.

1A comparable study resulting in a similar contagious mutant of the

avian flu has been carried out by Yoshihiro Kawaoka at the University

of Wisconsin, Madison. His paper was sent for publication to Nature,

and was subjected to a similar treatment as Fouchier’s paper. As said,

we will focus on the latter.

3.2. The Debate

The arguments contra are clear: The risk of terrorist

misuse of the information is considered bigger than the

P. J. D. DRENTH

126

negative effects of strangling such research through re-

strictive measures and regulations. “Some cases are

worth an exception to the principle of openness” said

Thomas Inglesby, the director of the Centre for Biosecu-

rity at the University of Pittsburgh in an interview for

Mailonline (18-11-2011). Epstein (2012) reasoned that

the argument that this kind of advanced basic research

cannot be understood or applied by terrorists may be an

illusion. “Today’s cutting-edge research becomes to-

morrow craft skill, which becomes the day after’s com-

modity”, as he stated. The conclusion is that the risks

outweigh the benefits, and that, therefore, this research

should not be done, and certainly not be published.

At the same time a number of good arguments pro

have been brought to the fore.

In the first place, there is the importance of knowing

and sharing knowledge with other scientists. Openness

and sharing knowledge is the cornerstone of scientific

development. And this scientific development cannot be

stopped. Fouchier, Herfst and Osterhaus [11] point out

that they only used information and methods that are

available freely from the scientific literature, and that

virologists could perform similar experiments even if

their method is not published.

The NSABB recommendation to publish the results,

but without the experimental details and the mutation

data that would allow replication of the experiments,

does not seem an effective and feasible solution. Science

can only develop through critical analysis and replication

by colleague scientists, an d they need full details for th at.

NSABB realised this also, and recommended, as said,

that detailed information should be shared confidentially

with to be approved experts that need to know. However,

aside from the near impossibility to keep such a publica-

tion secret very difficult questions arise immediately:

Who decides about the approval? Using which criteria?

Which mechanism will be used to share the info rmation?

In addition, within the legal rules of the World Health

Organisation (WHO) it is very difficult to refuse infor-

mation on a dangerous and contagious virus to any state

that requests such information.

Moreover, in this case there is the important implica-

tion for public health . What can be done in a lab can also

spontaneously happen in nature, and it is good to know

which mutations to watch for in case of an outbreak, and

to prepare for a timely development of vaccinations and

medication. As Fouchier, Herfst and Osterhaus [11] state

“nature itself should be considered the prime bioterrorist”.

Without knowledge of the possibility of this vicious

variant confiden ce in the traditional H5N1 strategy (only

birds and no airborne contagion) would be seriously fal-

lacious. In addition, lots of further questions need to be

researched: How does this virus spread between people?

How important is the aerogene spread? How stable is the

mutation? Can we generalise from ferret to human? The

view of the virologist Palese [12] is almost the opposite

of the NSABB advice: “The more danger a pathogen

poses, the more importan t it is to study it and to share the

results with the scientific community. Slowing down the

scientific enterprise will not protect the public, it only

makes us more vulnerable.”

Finally, pre-screening and censorship has a rather

harmful side-effect: Who would enter a research field

and carry out complex and time consuming research

without a guarantee that the significant results can be

published? Essentially, such restrictive measures would

terminate frontier research in this field of great impor-

tance.

3.3. Latest Developments

On 16-17 February 2012 the WHO organised an expert

meeting with a strong representation of the influenza

field, in which the importance of this kind of research

was unanimously underscored. A further consensus was

reached on the view that a shortened re-edited version of

the manuscript has no value, that sharing the details of

the study with a restricted, selected number of colleagues

is not practicable, and that th e benefits of the research for

science and public health are greater than the possible

risks of publicati on .

Further, neither the US government nor the WHO has

found practicable ways to share details of this research

confidentially only with selected colleagues. After the

Geneva WHO conference and the ardent discussions in

the professional and public press the US government

requested a second opinion of the NSABB. Fouchier and

Kawaoka were asked to defend their research and to

formulate their objections against the first advice. Given

their arguments and the conclusions of the Geneva con-

ference NASBB changed its opinion and decided now to

advise positively on the publication of the full manu-

scripts.

The US government accepted this NASBB advice.

The Dutch government did not agree, however, and

insisted on its right to exercise export control over this

potentially dangerous research, which is considered ap-

plied research. (The government has no right to wield

power over basic research). It forced Fouchier and his

group to ask permission for export, which they did under

protest. After careful weighing of the (scientific and pu b-

lic health) interests and the risks the government as yet

granted the export and the research was published.

4. Conclusions

The contentious issue discussed in this paper is a good

illustration of the dilemmas that dual research raises.

Taking extreme positions in such a dilemma should be

P. J. D. DRENTH

127

denounced. Both the extreme view of zero tolerance with

respect to the risks of research on dangerous viruses as

well as the extreme view that entirely dismisses these

risks, stressing the scientific progression and public

health benefits, have to be avoided. Personally I am in-

clined, given the convincing arguments pro, as discussed

above, to pronounce against the prohibition of this type

of research and its full publication, provided the re-

searchers take all necessary Biosafety measures, and

comply fully with the Code of Conduct for Biosecurity.

However, which stand one takes on the continuum be-

tween the two extreme positions remains a personal

choice, but should—contrary to the often indignant re-

actions in the public media—always be based on full and

reliable information, and result from a careful and re-

sponsible weighing of the risks and benefits.

The H5N1 case is an instru ctive illustration of the dual

use dilemmas in present day’s developments in bio-

technology. Given the uncertainties and lack of clarity

with respect to the distribution of responsibilities be-

tween the scientific world and governments in many

parts of the world further and better regulations are

needed. In my opinion Academies of Sciences, and In-

ternational Associations of Academies of Sciences (such

as ALLEA and IAP) are the right institutes to take up this

gauntlet.

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