Biosecurity- A 21st Century Challenge

2005·0.23 MB·

by  Carnegie Corporation of New York

2005
Carnegie
EDUCATION
Challenge
INTERNATIONAL PEACE & SECURITY
Biosecurity:
st
A 21 Century
INTERNATIONAL DEVELOPMENT Challenge
STRENGTHENING U.S. DEMOCRACY
Biosecurity:
A 21st Century Challenge
by M.J. Zuckerman
ABOUT THE AUTHOR
M.J. Zuckerman is a Washington, D.C.-based veteran journalist, author, newspaper reporter and editor, who has written extensively about
the intersection of technology, security, democracy and justice for more than 20 years.
The goal of Carnegie “Challenge” papers is to lift up ideas and issues in a way that we hope will elevate them to the national agenda. The subjects we
deal with, along with questions we explore, grow out of the work of Carnegie Corporation of New York but do not necessarily represent the focus of our
programs. For more information about the Corporation’s grantmaking activities, please visit our web site: www.carnegie.org.
Carnegie Corporation of New York was created by Andrew Carnegie in 1911 to promote “the advancement and diffusion of knowledge and understanding.”
Under Carnegie’s will, grants must benefit the people of the United States, although up to 7.4 percent of the funds may be used for the same purpose in countries
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seeks to carry out Carnegie’s vision of philanthropy, which he said should aim “to do real and permanent good in this world.” Currently, the foundation focuses
its work in four program areas: Education, International Peace and Security, International Development and Strengthening U.S. Democracy.
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©2005 Carnegie Corporation of New York

Introduction said Sam Nunn, a former Carnegie Corporation of
What physicists accomplished by unlocking the New York trustee and a global leader in the struggle
atom in the mid-20th century and engineers did by to control weapons of mass destruction, in a speech
revolutionizing information at the end of that century, in December 2004. He continued, “This potentially
the life sciences are doing with molecular biology and lethal combination creates an accelerating risk of cata-
genetics at the dawn of the 21st century. strophic terrorism.”
Each great advance in technology, it seems, pro- Vartan Gregorian, president of Carnegie Corpora-
duces uniquely challenging consequences. tion, agrees that this is an area to which attention must
Today, biotechnology is yielding life-enhancing be paid. He says, “Not only recent history but ex-
breakthroughs at a thrilling pace. Yet, an elite commu- amples drawn from conflicts stretching back into time
nity of scientists attending to these advances is issuing show us how quickly humanity can be overwhelmed
stern warnings that these powerful new tools may also by forces it wasn’t watching for. In that connection,
give rise to fiercely destructive forces. This life-giving the development of biological weapons certainly repre-
science, they insist, must be secured from abuse. Thus sents a force we must watch for with great vigilance.”
far, those who might be expected to respond—author- A June 1999 memo, retrieved from an al Qaeda
ities of government, private business or the academic computer after the fall of Afghanistan in November
community—have reacted sluggishly, if at all, foisting 2001, instructs that the means for building bioweap-
this security policy conundrum onto a very few in the ons capacity is to be found at western educational
science and policy communities who recognize the institutions, which “allow easy access to specialists.”
vast rewards and potential dangers inherent in today’s Other reports indicate the terrorist group’s interest in
life sciences. obtaining toxins, specifically, anthrax. Official pro-
History demonstrates that many advances in nouncements assessing terrorist sophistication in bio-
technology are adapted to warfare, bringing about weapons development run the gamut, from a “fairly
new, more effective forms of weaponization. Advances rudimentary” facility in Kandahar, Afghanistan, to
in mechanized combat killed more people in the 20th reports of an “extensive and well organized” program,
century than died in all of history’s earlier conflicts formerly operated at several Afghani sites, “[t]wo of
combined. With each iteration of technology, the these sites contained commercial equipment and were
tools of warfare become more accessible, not only to operated by individuals with special training,” whose
wealthy and powerful nations but also to the rela- “primary interest” was attempting to create “Agent
tively unremarkable individual with sufficient access, X” —a reference to a so-called unconventional, man-
a modicum of ability and, perhaps most important, made, designer bug.
determination. And there is reason to believe that the Critics charge that there is entirely too much
West’s most determined enemies are in hot pursuit of hype and too little evidence of a clear and present
these new opportunities. threat; some are particularly concerned with the
“Today’s world combines the growing access to tendency to take for granted that a disaster is just
biological materials and computer power with the an- waiting to happen. They say the learning curve
ger and hatred it could take to use them as a weapon,” for producing a significant bioweapon is far more
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complicated than is generally acknowledged. They it is important to inform that judgment with training,”
claim the massive infusion of U.S. spending on “in- says Gigi Kwik Grönvall, an associate at the Center for
cident response,” also known as “civilian biodefense” Biosecurity and assistant professor of medicine at the
—rising from $410 million in FY01 to more than University of Pittsburgh Medical Center (UPMC).
$7.65 billion in FY 05—might be better invested In any case, it stands to reason that securing bio-
elsewhere, for example, in the battle against malaria, technology requires training to certain standards and
tuberculosis and AIDS, which collectively claim five establishing some verifiable form of oversight. But
million lives annually. They argue for a comprehen- who decides? Academia? Industry? Government? The
sive, international approach to biosecurity. international community?
The necessary alternative, they argue, is a course The United States has opted for a go-it-alone,
of action that addresses the underlying problems, not domestic approach. In 2001, the U.S. blocked efforts
merely the threats. to create enforcement provisions for the 1972 Biologi-
“I want to change the boundary conditions to cal Weapons Convention (BWC), signed by 151 na-
the problem, the environment in which the problem tions, including the United States, which have agreed
exists, not just say, ‘it is inevitable that it will happen to ban—to forgo developing, creating or stockpil-
so here is what we will do.’ I want to change the en- ing—biological weapons. The U.S. position was that
vironment so that the problem itself takes a different the proposed enforcement mechanism was too weak.
form,” says Matthew Meselson, a microbiologist who The United States has created a domestic regu-
is the director, at Harvard University, of the Harvard latory environment for biosecurity overseen by the
Sussex Program on Chemical and Biological Warfare National Institutes of Health. Any facility—such as
Armament and Arms Limitation. Meselson has been a university, and in some cases, private industry—re-
a leading biosecurity activist for more than 30 years. ceiving federal funds, must maintain a self-governing,
The goal, as Meselson and others define it, is to peer-review panel to secure sensitive research and re-
manage problems that may enable the use of bio- solve ethical dilemmas, such as the appropriateness of
weapons. Thus, the thinking is to construct a security publishing research findings that could be abused.
regime for biology. While the terminology of this “It is entirely appropriate for the United States
realm is still in flux, there is some agreement that bi- to develop a system to provide oversight of research
osecurity can be viewed as a subset of biosafety, which activities domestically, but the effort will ultimately
encompasses the broad concept of practicing biologi- afford little protection if it is not adopted interna-
cal science in a safe environment. Put another way, tionally,” according to the non-partisan, National
biosecurity is about keeping the work safer and implies Academies’ report entitled, Biotechnology Research in
the prevention of the deliberate misuse of pathogens an Era of Terrorism. Better known as the Fink Re-
and toxins. port, after Gerald R. Fink of MIT who chaired the
“Both biosafety and biosecurity require that scien- eighteen-member Committee on Research Standards
tists exercise their judgment—Is the project safe? What and Practices to Prevent the Destructive Application
safety level should the experiment be performed at? Are of Biotechnology that developed it, the report has set
we taking all the right safety/security precautions?—and the benchmark—both within the U.S. and interna-
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tionally—for biosecurity discussions since its release A Life Sciences Perspective
in January of 2004. The Fink Report describes the problem in a nut-
Biosecurity is, by its nature, an international shell: “Biotechnology represents a ‘dual use’ dilemma in
problem, for neither the spread of disease nor the which the same technologies can be used legitimately
dissemination of scientific information respects geo- for human betterment and misused for bioterrorism.”
political borders. The world is only as secure from the Put another way, every advance in biotechnology
abuse of biotechnology as the weakest standards ap- presents a double-edged sword.
plied by any single nation. For example, ongoing efforts to develop an aero-
“Without international consensus and consis- sol measles vaccine promises relief to the developing
tent guidelines for overseeing research in advanced world where infectious diseases are rampant and often
biotechnology, limitations of certain types of research fatal. (Measles kills at least a half-million children
(in the U.S.) would only impede the progress of bio- annually in the developing world.) Traditional treat-
medical research here and undermine our own na- ments involving injections are logistical nightmares.
tional interests” to engage in work overseas, the Fink An aerosol would be a vast improvement.
report concludes. But once a microbe is aerosolizable, there is poten-
Increasingly, there is momentum toward treating tial for misuse. A deadly organism could be added to
biosecurity as a management problem, necessitating or used in place of the original microbe and, employ-
shared understanding by two divergent communities: ing that same technology, be disseminated not as a
biologists and policymakers. vaccine but a harmful organism.
“Any effort to ameliorate the problems posed by That’s “dual use.”
biological weapons requires … recognition that there Another case in point: the Pentagon’s research
is no solution to this problem: it requires ongoing and arm, DARPA (Defense Advanced Research Projects
permanent management,” declares the current, inter- Agency), is working to create what biologists are refer-
im report of the international Weapons of Mass De- ring to as “the human immune system on a chip,”
struction Commission (WMDC). Furthermore, the which would permit scientists to conduct simulated
WMDC contends, “managing the biological problem human trials of new drugs without endangering hu-
requires a set of policies and commitments stretching man guinea pigs. The technology promises to sub-
from the individual to the international.” stantially reduce the time it currently takes to bring
In this context, the fundamental approach ad- a new drug to market, which is typically more than
opted by Carnegie Corporation of New York focuses a decade. The Defense Science Board predicts that a
on the individual whose responsibility it is to inform breakthrough of this type could help streamline the
the broader community of science and civilization. “bug-to-drug” timeframe to 24 hours within the next
Therefore, the Corporation devotes much of its work 20 years.
in this area to convening and promoting influential However, the dual-use threat means that the same
partnerships in science and policymaking to enhance technology could also assist in the rapid development
communications intended to resolve security dilem- of a particularly nefarious toxin.
mas arising from biotechnology. Perhaps the best known and most frequently
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cited example of the dangers of dual use arose from “Biotechnology aims at improving medical and
research in Australia in the late 1990s, intended to public health responses and thus saving lives; if you
create a viral contraceptive to curb a rampant rabbit don’t share information, the science slows down and
and mouse population. During that research, scien- people die daily,” says Ronald Atlas, co-director of the
tists stumbled upon a way to supercharge mousepox, Center for the Deterrence of Biowarfare and Bioter-
increasing its virulence and making it resistant to rorism at the University of Louisville, in Kentucky.
vaccines, causing fatalities in 60 percent of test cases. Atlas, an authority on bioethics who served on the
Fortunately, mousepox is harmless to humans. Unfor- Fink Committee, notes the slippery slope involved in
tunately, if smallpox was substituted for mousepox, it defining information as “good,” and therefore worthy
could—could—create a strain of the disease without of publication, versus “dangerous.”
any known treatment, and double the normal fatality “You get into a debate about things of value versus
rate for smallpox in humans. dangers,” he says. “You could go back to the invention
Ignore for the moment the fact that the only sam- of steel, which gave us skyscrapers and bridges but you
ples of smallpox virus in existence are as tightly con- have to balance that with the fact that the same mate-
trolled as highly enriched uranium: after the World rial is used for making guns.”
Health Organization declared smallpox eradicated in
1980, the only remaining samples were secreted away at
S
a U.S. lab in Atlanta and a Soviet lab in Koltsovo, Russia. till, in an age of terrorism, the dual-use issue de-
The significant issue facing the Australian re- mands that someone take responsibility for controlling
searchers was what to do with their findings: publish knowledge that could cripple civilization.
the results or bury them. They hesitated. But ulti- The Fink Report’s discussion of dual use and bi-
mately, they shared their findings, publishing the osecurity comes down heavily in favor of a bottom-up
results just two years after they first realized what they approach, advocating self-governance by the life sci-
had produced. In part, their decision to publish was ences community; perhaps not surprisingly, the panel
predicated on finding that others were working in the was dominated by academicians whose own interests
same area and it seemed reasonable to assume that it favor self-governance and a “publish-or-perish” ap-
was only a matter of time before someone came upon proach to research findings.
the same findings. And, there was the need to set out The report found that the U.S. Patriot Act of
some warning and create awareness so that counter- 2001 and the Bioterrorism Preparedness Act of 2002
measures could be researched. Publication of the find- do a good job of addressing dual use by establish-
ings, however, created a firestorm of media reaction ing a set of controls and regulations over federally
and wrenching soul searching for the life sciences. funded biotechnology. Those laws, still being phased
Life scientists typically bridle at the suggestion of in, mandate a regulatory scheme that tracks the use
keeping research results secret, arguing that a greater of dangerous pathogens creating a database of labs
good is almost always served by sharing results, regard- working in sensitive areas.
less of whether those findings may be of use to an out- “However,” the Fink Report continues, “they do
law nation or terrorists. not currently address the potential for misuse of tools,
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technology or knowledge … for offensive military or Science Advisory Board for Biosecurity the au-
terrorist purposes. In addition, no national or interna- thority to periodically review current laws regulat-
tional review body currently has the legal authority or ing biological materials and personnel.
self-governance responsibility to evaluate a proposed 6. Engage Life Sciences in Security. Develop
research activity prior to its conduct to determine channels of sustained communications between
whether the risks associated with the proposed re- security officials and the life sciences community.
search, and its potential for misuse, outweigh its po- 7. Harmonize International Oversight. The scien-
tential benefits.” tific community, with the support of international
Continuing, the report urges the creation of “a organizations, should create an International
comprehensive system, both nationally and interna- Forum on Biosecurity to “harmonize national,
tionally” to address those policy shortcomings. “Only regional and international measures,” with those
a system of international guidelines and review will of the United States.
ultimately minimize the potential for the misuse of
biotechnology,” the report states. It also made seven Responding to the Fink Report, the Department
recommendations for a more comprehensive biosecu- of Health and Human Services announced its intent,
rity regime: in March 2004, to create a 25-member National Sci-
1. Educating the Scientific Community. Profes- ence Advisory Board for Biosecurity, charged with du-
sional societies should create programs to educate ties that will include advising or providing guidance on:
scientists about the dual-use issue and their re- • Strategies for local and federal biosecurity over-
sponsibilities to mitigate risks. sight for all federally funded or supported life sci-
2. Review Plans for Experiments. The Department ences research.
of Health and Human Services should establish • Development of guidelines for biosecurity over-
stronger review processes for experiments repre- sight of life sciences research and providing ongo-
senting potential misuse. ing evaluation and modification of these guide-
3. Review at Publication Stage. Scientists should lines, as needed.
review submissions for publication to determine • Strategies to work with journal editors and other
the potential national security risks. “This part stakeholders to ensure the development of guide-
of the system,” the report says, “should be based lines for the publication, public presentation and
on the voluntary self-governance of the scientific public communication of potentially sensitive life
community rather than formal regulation by gov- sciences research.
ernment.” • Development of guidelines for mandatory pro-
4. Creation of a National Science Advisory Board grams for education and training in biosecurity
for Biodefense (NSABB). Created by the De- issues for all life scientists and laboratory workers
partment of Health and Human Services, the at federally funded institutions.
board would be a vital forum for advice, guidance, • Development of a code of conduct for life scien-
oversight and review. tists and laboratory workers that can be adopted
5. Protection Against Misuse. Permit the National by federal agencies as well as professional orga-
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nizations and institutions engaged in the perfor- ment where all the key players and all the key stake-
mance of life sciences research domestically and holders are contributing partners to the management
internationally. of risk …and that imposes a set of requirements on
government and a wider array of players than tradi-
The NSABB, however, remains only a work in tionally has been the case,” which includes private
progress. enterprise, academia, insurance companies, the media,
the medical community and public interest organiza-
tions, to name a few.
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n a related development, in April 2005, after years A more traditional, top-down, management
of efforts, organizers launched the International approach to biosecurity is advocated by John Stein-
Council for Life Sciences (ICLS), a private, member- bruner, director of the Center for International and
ship-based organization, intended to identify and Security Studies at the University of Maryland, who,
manage “biological risks” while facilitating a com- in stark contrast to others, insists that the stakes are
munity partnership for “governments, international too high to have anything less than a mandated, le-
intergovernmental organizations and the life sciences gally binding international system of checks and bal-
community—private industry, academia, nonprofit ances scrutinizing the research and procedures of every
laboratories and nongovernmental organizations.” facility involved in biotechnology. The goal should be
The ICLS is the creation of two independent “complete transparency” he says.
research groups, the Chemical and Biological Arms Presently, approximately 400 mostly academic
Control Institute (CBACI) and the International institutions receiving grants from the National Insti-
Institute for Strategic Studies-US (IISS-US), with the tutes of Health (NIH) for recombinant DNA research
support of the Nuclear Threat Initiative. must comply with federal oversight guidelines. Some
The ICLS laid claim to serving as the interna- corporate facilities voluntarily comply as a good-faith
tional harmonizing influence described in the Fink effort to observe a “gold standard for safety,” according
Report. to NIH. Those guidelines mandate that each facility
Michael Moodie, president of CBACI, said the appoint and register an Institutional Biosafety Com-
creation of the ICLS was modeled on the nuclear pow- mittee (IBC) —a panel of at least five members, at
er industry’s actions after the meltdown at the Cher- least two representing the local community and one
nobyl nuclear power plant in Ukraine, when an inter- from the lab in question—which must review and ap-
national consortium of power plant operators came prove any biohazardous research at their facility. The
together to adopt strict safety standards, intended to IBC is overseen by a 21-member Recombinant DNA
reassure a terrified public and, more importantly, stave Advisory Committee (RAC), which is overseen by
off draconian government regulation of the industry. the Director of NIH; only the most sensitive projects
However, Moodie sees the ICLS as engaging a require review by all three.
much broader set of stakeholders in “managing the po- Steinbruner says that limiting oversight to those
tential implications of rapidly spreading knowledge.” facilities funded by NIH is inadequate and, while
He says the goal of ICLS is to “create an environ- the NIH procedures may provide a sufficient degree
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of local safety, there is a need to create conforming western U.S. carry plague, for example; other toxins
international standards, “so that a proposal made in can be purchased, some legally, others as stolen goods);
the U.S. would get the same treatment in Germany or the necessary laboratory tools are not extraordinarily
Nigeria.” sophisticated, and there may be millions of individuals
He envisions a four-tier system of oversight and, with sufficient knowledge to create large quantities of
where appropriate, licensing on a local, national and virulent toxins.
international basis for clearances to conduct sensitive “Only a thin wall of terrorist ignorance and inex-
research or access sensitive information and dangerous perience now protects us,” says Richard Danzig, a Fel-
materials. low at the Center for Strategic and International Stud-
However, any real movement toward a resolution ies and author of a forthcoming Aspen Institute report,
is some time off, he says. Proliferation of Biological Weapons into Terrorist Hands.
“The scientific community is in the embryonic Thus, the reasoning goes, if it’s only a matter
stages of dealing with this,” he explains. “And policy- of time, our nation’s best course of action is “inci-
makers aren’t going to deal with it until there is much dent response,” —preparing for the worst, creating
more consensus than there is now.” surveillance systems to provide early detection and
warning, manufacturing huge stockpiles of vaccines
An Event-Driven Society and antibiotics, training first responders, expanding
We live in an event-driven society. Arguably, it’s hospital isolation wards and designing emergency
one of the failings of democracy. Dramatic shifts in quarantine plans.
public policy all too frequently require dramatic events Next, there are those who say that a devastat-
to build a consensus of public opinion. ing incident is possible, if we do not prevent it from
In some instances, policymakers have succeeded happening. However, many leading activists take
in making the case for change by clearly demonstrat- issue with a prescription focused solely on respond-
ing a “clear and present danger.” ing to a worst-case scenario. While conceding the
The popular “clear and present danger” argument potential for a crisis, they condemn doomsayers’
made with respect to biosecurity states: The only ques- conclusions as pointlessly alarming and dangerously
tion regarding a mass-casualty bioweapon incident “is defeatist. These activists insist that accepting the in-
not whether, but when” it will occur—and the popular evitability of this version of future events threatens
time frame ranges from as little as five years to no fundamental tenets of civilization. If we do nothing
more than twenty years. to prevent biowarfare or bioterrorism, they say, those
This expression of the biosecurity problem has worst-case scenarios will most certainly come to pass
established the clearest dividing line between factions and the consequences, no matter how they are man-
to the debate. aged—massive quarantines, curtailing food distribu-
First, those who embrace the “not whether but tion, closing schools—are unacceptable outcomes for
when” concept as inevitable, either by some failure in modern society.
simple safety procedures or by malfeasance, argue that The necessary alternative, they argue, is for a
the necessary toxins are accessible (prairie dogs in the course of action that addresses the underlying prob-
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