Below are three concepts that illustrate the current challenge presented by biological weapons (BW)…

1. “The dual use dilemma is absolute.” – Kathryn Nixdorff in Verifying Treaty Compliance: Limiting Weapons of Mass Destruction and Monitoring Kyoto Protocol Provisions

At an AAAS panel discussion last week, Senior Bio Advisor of the U.S. National Counterproliferation Center, Dr. Lawrence Kerr, explained that all life science research is dual-use by nature. The very same technologies, techniques, and studies designed to create pharmaceuticals, for instance, can be employed nefariously to manipulate biological agents (pathogens and toxins) and identify exploitable vulnerabilities in the human body.

Dr. Koblentz takes this concept a step further, arguing that the biological dilemma is more accurately described as “multiuse”:

In [Living Weapons], the term “multiuse” is used to highlight the distinct but overlapping applications of biotechnology in civilian, defensive, and offensive domains. The old distinction between military and civilian applications of biological and biotechnology has become more blurred in recent years as more civilian institutions become engaged in defensive research and military organizations become more interested in applying biotechnology in areas of energy, materials science, logistics, medicine, and electronics.

2.    “In the life sciences, proliferation is over.” – Dr. Lawrence Kerr at AAAS panel discussion, 8 December 2009

Techniques and technologies in the most advanced biological fields are already spread across the globe and across populations. The life sciences’ immeasurable potential for legitimate and constructive use, the culturally entrenched value placed on improving human health worldwide, the aforementioned dual-use dilemma, and decreasing costs have made most biological materials and biotechnologies largely uncontainable. And from a global public health perspective, they should not be contained.

It is possible now for amateur biologists to genetically alter or synthesize pathogens out of their own closets. These at-home “biohackers” can “tinker with the building blocks of life in the comfort of their own homes” for a modest price.

Striking the proper balance between reaping the benefits of the life sciences and reducing the risks of technological abuse is extraordinarily tricky. Professor Barry Kellman of the International Security and Biopolicy Institute has called biothreat policy “the most multifaceted, multidimensional, nuanced undertaking in the entire security domain.”

3.    “What do you mean we can’t do this? We’re doing it now.” –Dr. Raymond Zilinskas, quoting the scientific community’s response to an assessment of biotechnological capabilities

The biotechnology industry is moving at a revolutionary pace. Dr. Raymond Zilinskas, Director of the Chemical and Biological Weapons Nonproliferation Program at the James Martin Center for Nonproliferation Studies, co-authored a 2002 report detailing the threat of bioterrorism. According to the Washington Post, the report noted that “some key biotechnologies would be achievable only three to four years from then.” However, by the time the final report was sent out for review by bench scientists, the report’s expert panel learned that some of those technologies had been developed. “It shows how fast the field is moving,” noted Dr. Zilinskas.

From altering biological agents at their most fundamental building blocks to “de novo” synthesis of preexisting or new microbes, the wonders of biotechnology often seem boundless. The risks presented by advances in biotechnology will increasingly demand attention in the future.

Dr. Marie Isabelle Chevrier – Professor at UT-Dallas, member of the Center’s Scientists Working Group on Biological and Chemical Weapons, and Chair of the Board of Directors of the Biological Weapons Prevention Project in Geneva:

Ellen Tauscher’s speech to the Meeting of the States Parties of the Biological Weapons Convention was much anticipated by delegations. Yet there was little excitement or enthusiasm by the delegation following her speech. Delegations and NGO observers welcomed the change in tone from earlier US interventions during the Bush administration, contrasting it, in particular, with the strident address by John Bolton to the 5th Review Conference in 2001. Nevertheless the lack of specificity of proposals in Tauscher’s address was notable. People wondered about the meaning of language in the statement such as “compliance diplomacy” and “robust bilateral compliance discussion.” Optimists greeted the statement with hope that the statement will be followed by real engagement absent the arrogance of the past while pessimists found little if anything in the statement that would lead to real policy changes from the Bush administration. The inclusion of CBMs on an open website was generally welcome, as a small measure of transparency but not something that would likely lead to real confidence in compliance. Many NGOs are looking forward to greater transparency among all stakeholders rather than mere “bilateral…discussions.”

Dr. Amy E. Smithson – Senior Fellow at the James Martin Center for Nonproliferation Studies:

Tauscher tabled a modest, constructive set of proposals, but given the $49 billion in U.S. biodefense spending since 2001, the international community will want more in terms of transparency from Washington than just posting the US confidence-building declarations?already available to all member governments?on the web and inviting one person to Ft. Detrick.   New money earmarked for building international disease surveillance and reporting capacities would have more emphatically conveyed U.S. support for thorough implementation of the International Health Regulations.  If the Obama administration hopes to claim the leadership mantle in the biological nonproliferation arena, they will have to bring something much bolder to the table.  The sooner they do, the better.

Dr. Jonathan Tucker, Senior Fellow at the James Martin Center for Nonproliferation Studies:

Although none of the elements of the U.S. strategy are new, taken together they provide a comprehensive and cooperative approach to the prevention of biological threats, both natural and deliberate. The main disappointment is the strategy’s lack of ambition with regard to strengthening the Biological Weapons Convention, both with respect to the treaty’s institutional deficit and the festering suspicions of non-compliance by a few member states. The measures proposed to address compliance concerns—increased transparency, confidence-building measures, and bilateral diplomacy—appear too weak to make much of a difference.

The Obama administration in Geneva yesterday formally revealed its new strategy for strengthening the Biological Weapons Convention (BWC).

Anticipating the release of the White House’s “National Strategy for Countering Biological Threats,” Dr. Jonathan Tucker, a senior fellow with the James Martin Center for Nonproliferation Studies, told Global Security Newswire last Friday: “What’s important is the U.S. government is giving political attention to this issue, and making it clear the U.S. is not a one-trick pony and that in addition to the very ambitious nuclear agenda, the government is also very concerned about biological weapons.”

Undersecretary of State Ellen Tauscher did indeed proclaim the administration’s commitment to the issue. However, the strategy has drawn criticism for reaffirming the Bush administration’s opposition to creating an international monitoring system to verify treaty compliance…

It is important to understand why the Bush administration announced eight years ago that a BWC verification protocol was “not in the best interests of the United States and many other countries.” First, the Bush team felt that the protocol’s provisions were overly influenced by particular nations’ demands. According to FAS, Iran, who played a key role in the deliberations of the Ad-Hoc Group tasked with drafting the protocol, “insisted throughout that all export control regimes, and particularly the Australia Group arrangements, be totally abolished.” In addition, according to Dr. Tucker, Russia sought to define the “types and quantities” of pathogens and toxins banned by the agreement, thereby limiting its scope. Russia and Iran continue to seek such provisions.

An intrusive verification protocol was also perceived by the Bush administration, and perhaps now by the Obama administration, as a burden to biodefense research and the growth of the biotechnology industry. Although a broad interpretation of the BWC, particularly Article X, allows for the production of small amounts of hazardous biological agents for peaceful study, a verification protocol would subject the U.S. biodefense and biotechnology complex to “increased inspection costs and bureaucratic hurdles.” Moreover, the access required for inspections could also threaten to expose vulnerabilities in the U.S. biodefense shield or reveal lucrative pharma-industry secrets.

These concerns appear not to have changed since the Bush administration’s rejection of the verification protocol in November 2001. Meanwhile, biotechnology has continued to advance at a revolutionary pace, advanced techniques have been disseminated around the world and throughout populations, and the biological dual-use dilemma has been amplified. Given these trends, effective monitoring through a verification protocol may not be possible. For this reason, Undersecretary Tauscher explained, “We have carefully reviewed previous efforts to develop a verification protocol and have determined that a legally binding protocol would not achieve meaningful verification or greater security.”

Verification protocol aside, the Obama administration’s new strategy contains a collection of objectives to mitigate biological threats. One of those objectives is to promote global health security, which includes providing assistance to other nations to bolster their disease surveillance, detection, diagnosis, and response programs. Such an approach links security with public health, thereby countering not only nefarious biological weapon threats but also natural infectious disease outbreaks. The White House strategy also includes a variety of confidence and transparency building measures.

But in a press release yesterday, the experts at the James Martin Center for Nonproliferation Studies suggest it may take more far-reaching steps than are presented in the new strategy to truly impact the BWC. A close look at the White House strategy document makes it seem more like a reiteration of recommendations generally supporting biological threat reduction rather than a fresh roadmap for strengthening the BWC as an effective central pillar. In fact, the 23-page document’s emphasis on the BWC is limited to a brief pledge in the introduction to uphold the treaty’s obligations, fleeting mentions in a few bullet points, and a single subsection about the need to revitalize the BWC in one of the seven strategic objectives.

Harnessing Trade Data for BWC Compliance

On October 7^th, Global Green USA hosted Gunnar Jeremias of the University of Hamburg’s Research Group for Biological Arms Control, who described a novel strategy to support compliance with the Biological Weapons Convention.

Jeremias gave a presentation entitled “Harnessing Trade Data for BWC Compliance.” His proposal, part of a project that commenced in 2004, is to enhance the mechanisms and detail by which international trade data is recorded and to comprehensively analyze that data in order to identify suspicious biotechnological research activity. Underling this strategy is the idea that, through astute and expert analysis, the dual-use dilemma can be partially overcome.

Jeremias quoted BW expert Kathryn Nixdorff’s assertion that “the dual-use problem in biotechnology is total” (my emphasis). Trade data analysis can provide a rough picture of research intent, thereby mitigating the dual-use dilemma.  Specifically, Jeremias is encouraging state parties to augment the World Customs Organization (WCO) Harmonized System by increasing transparency and instituting more specific coding for trade items. In Jeremias’ view, biotechnology items are not adequately identified under the Harmonized System, which assigns standardized numbers to trade items for recording and monitoring purposes. Growth media is currently one of the few items with an individual code, while most biotech items are classified by broad basket codes. Jeremias explains that the Harmonized System must employ individual codes for all biological dual-use items. Open publication of more detailed trade data will then provide meaningful information for analysis by NGOs or governments.

This strategy is certainly not a panacea for identifying foreign biological weapons activities, and there are some serious limits to its effectiveness. For example, the already large and established biotechnological industries of many countries could overshadow the significance of trade data (specifically imports). Analysis of trade data must not occur in a vacuum, but rather must be done vis-à-vis a nation’s established biotechnological capabilities. A sizeable indigenous industry could render trade data inseparable from the dual-use dilemma, or it could make trade data inconsequential due to insignificant volume. In addition, this strategy does not confront the threat of bioterrorism, which would result from small-scale non-state activities rather than high-volume national programs.

Bioreactors are currently classified by the same coding as brewery equipment under the Harmonized System

Nonetheless, the strategy could be incredibly useful as a supplement to intelligence activities and diplomacy in identifying and thwarting national biological weapons development. The establishment of conclusive evidence of a biological weapons program based on trade data is unlikely, but astute analysis would identify suspicious trade patterns and emerging trends. According to Jeremias, UNSCOM and UNMOVIC, the UN inspection regimes created to assess Iraq’s WMD programs, have demonstrated the value of item transparency in identifying suspicious biological research. Through their analysis of biological research materials in Iraq juxtaposed with Iraq’s biotechnological capacities, UNSCOM and UNMOVIC were able to identify biological weapons activities on the part of Iraq. Detailed and transparent trade data would provide similar insights into other countries’ biotechnological intentions.

In addition, implementation of the proposal would also have the positive effects of increased transparency. Transparency is a crucial lynchpin in averting international conflicts. Greater international transparency is needed specifically with regards to weapons and scientific research programs in order to avoid the misunderstandings and deceptions that lead to hostile international competition. Biological research is no exception. Increased transparency, as explained in an earlier post, may prove to be fundamental in the prevention of a secretive international biological weapons arms race—something that may, in fact, already be in its nascent stages. Jeremias’ proposal would contribute significantly to the transparency effort.

The transparency afforded by more detailed and comprehensively monitored trade data combined with proactive endeavors of openness by individual nations (particularly those that do not import biotechnological materials in great volumes) would establish a more stable international situation and avert dangerous biological competition.

The Role of National Security Export Controls in a Globalized Economy

On October 16^th, the Woodrow Wilson Center hosted Mitchell Wallerstein (Dean of the Maxwell School of Public Affairs, Syracuse University) and Patricia Wrightson (Program Director of the Policy and Global Affairs Division, The National Academies) to speak about the U.S. export control system.

Operating with the understanding that “the national security controls that regulate access to and export of science and technology are broken,” the National Research Council of the National Academies convened the Committee on Scientific Communication and National Security in 2007. Subsequently, the National Research Council established the ad hoc Committee on Science, Security and Prosperity to propose policy solutions. The co-chairs of the committees were Brent Scowcroft and John L. Hennessy, President of Stanford University. This “select group of national security officials and leaders from the sciences, the defense industry, the information technology sector, academia, and the legal community” produced the 2009 report Beyond ‘Fortress America’: National Security Controls on Science and Technology in a Globalized World. Mitchell Wallerstein was a member of the committees, while Patricia Wrightson was a member of the project staff for the committees.

Invoking the report’s title, Wallerstein argued that we must overcome ‘Fortress America’ thinking—the strain of thought that assumes the U.S. is the primary source of most useful military and scientific technology in the world, and that the U.S. can continue to deny these materials to foreign countries without damaging economic interests. In reality, suggested Wallerstein, excessive export controls are hurting U.S. national interests and economic competitiveness. The unilateral attitude toward export controls held by the U.S. does not reflect the reality of a widely distributed high technology global landscape.

As a result of our controls over materials and technologies that remain uncontrolled by other nations, the U.S. harms itself in the following ways, according to Wallerstein:

1. The Department of Defense is deprived of cutting-edge products: domestic and foreign companies shy away from dealing with DOD in order to avoid the U.S. export control regime
2. The U.S. military is sometimes unable to outsource repair and maintenance of equipment to venues close to battlefields
3. Loss of access to foreign military capabilities, scientific and technological developments
4. Increased cost of doing business relative to foreign companies
5. Creation of markets for foreign competition
6. U.S. universities have difficulty recruiting and retaining foreign researchers
7. U.S. companies must compartmentalize information, leading to further disincentives for research talent and damage to competitiveness

For this reason, the Committee on Science, Security and Prosperity recommended an overhaul of the U.S. export control system through the most effectual mechanism possible: Presidential initiative. The committee recommended that a single administrative entity (a “one stop shop”) be set up to coordinate all licenses. The committee also recommended the maintenance of a “fundamental research exemption” as well as the creation of an “economic competitiveness exemption,” which would enable the export of dual-use items that are “widely and legally available” elsewhere. In addition, the committee recommended loosening the control of the flow of people in addition to materials. The committee suggested that visa processes be streamlined for researchers in order to maintain and enhance U.S. access to the reservoir of foreign scientific talent.

It is important to note that the committee does not suggest a total elimination of export controls. Their goal is not to completely deregulate the export control system for deregulation’s sake; instead, they have iterated that their fundamental interest is U.S. national security, of which economic competitiveness is an essential element. Thus, their goal is to deregulate controls on specific items so as to maintain U.S. market competitiveness while still not sacrificing U.S. security on other fronts, such as that of nonproliferation. This requires export control reassessment on an item-by-item basis, including items that are currently covered by specific export control arrangements.

Currently, National Security Advisor Jim Jones and National Economic Council Director Lawrence Summers are currently overseeing an export control review effort, which Wallerstein and Wrightson pointed to as an illustration of how seriously President Obama is taking the issue. Concerns remain regarding the proliferation implications of loosening export controls to any degree. Nonetheless, export controls have been a contentious and gridlocked issue for many years now. A review, in and of itself, should be seen as a useful endeavor.

Synthesis

The two studies described above are significantly different in content, purpose, and recommendation. The first is focused on biotechnology, whereas the second is focused on a wide range of technologies. The first is aimed at enhancing the global nonproliferation regime, whereas the second is aimed at protecting U.S. economic competitiveness. The first deals with monitoring mechanisms, whereas the second deals with control mechanisms.

Nonetheless, the two studies are similar in that both identify the heightened need for a better understanding of commerce flows as the international market becomes more globally integrated and dynamic. It is within this increasingly complex, open, and globalized system of commerce that proliferation of sensitive and potentially destructive technologies takes place—leading to the ever-increasing challenge of averting proliferation threats. At the same time, market interconnectedness also enhances national economic growth. This situation demands astute and vigilant eyes.

In addition, both studies recommend an analysis of commerce flows on an item-by-item basis. According to the reasoning implicit in both studies, only through nuanced understandings of market flows may nations balance the importance of technological and economic development with the hazards of proliferation. Nuanced understandings require awareness of the following, among other things: the status and nature of items on an individual basis, national scientific and technological capabilities, already established trade trends, and emerging trade trends. Consideration of both proliferation hazards and economic dynamics is vital to the interests of individual nations. As both studies point out, we must operate using the full details of the global market rather than function in generalities.

Legislation to Protect the Homeland

Sen. Lieberman made this comment on September 8^th, during his introduction of S. 1649, the WMD Prevention and Preparedness Act of 2009, which he co-sponsored with Senator Susan Collins (R-ME).  The legislation will implement a wide variety of recommendations from the Graham/Talent Commission to reduce the American homeland’s vulnerability to bioterrorism.  It aims to strengthen and universalize biological and biotechnological research security standards by introducing an integrated set of pathogen risk tiers, implementing risk assessment protocols, overhauling personnel reliability assessments, as well as other measures.  The legislation also lays out new blueprints for preparedness plans, such as networks for communications and access to countermeasures.

Since the FBI’s conclusion in August 2008 that the sole perpetrator of the 2001 anthrax letters was an American microbiologist working in a government facility, the threat of rogue scientists has been a particularly high-profile concern.  On September 22^nd, the Senate Homeland Security and Governmental Affairs Committee held a follow-up hearing on the Lieberman-Collins bill. As one of the hearing’s witnesses, Bob Graham indicated that a rogue scientist is the most likely scenario in which a biological weapon attack is carried out.  Later that day, the Senate Judiciary Committee’s Subcommittee on Terrorism and Homeland Security held a similar hearing, entitled “Strengthening Security and Oversight at Biological Research Laboratories.”  The scheduling of two similar hearings so close to one another may be an important indication of the awareness on the Hill of serious bioterrorist threats.

A recently released National Research Council report assessed this issued, concluding that “there is no ‘silver bullet,’ that is, no single assessment tool that can offer the prospect of effectively screening out every potential terrorist” (9).  Nonetheless, a wide variety of protective measures will drastically reduce that risk.  The NRC report gives nine biosecurity recommendations (see the Executive Summary), which have been largely addressed by the Lieberman-Collins bill.  On top of the NRC report, the GAO has issued two relevant reports recently.  A July report identified gaps in security at high-containment laboratories, while a September report calls for a national strategy for oversight on high-containment laboratories, which would establish “uniform rules governing the planning, construction, accreditation and operation of the nation’s most sensitive biological defense laboratories” (GSN).  According to Global Security Newswire, federal officials and independent experts have been having difficulty determining which agency should take the lead on that agenda.  It is unfortunate that parochial politics and bureaucratic stalling are getting in the way.  Nonetheless, it is reassuring that people are talking about these critical issues.

The U.S. biological research complex has been plagued in the past by problems of security, standardization, and accounting (see here).  The volume of visible activity contributed over the last few months to the U.S. biosecurity establishment is encouraging; it seems that the country is now moving in the right direction to eliminate these vulnerabilities.

Legislation to Protect the World

Domestic legislation and activities aimed at protecting against bioterrorism not only serve to protect individual countries but also support the international movement to fortify the world against nefarious biological threats and proliferation.  An international multilateral treaty, the Biological Weapons Convention (BWC), sits at the center of this movement.  However, the BWC lacks an international implementation body and contains no provisions for monitoring or verifying compliance with the treaty.

As stipulated by Article IV of the treaty, the onus is placed on the honest participation and initiative of individual member nations:

Article IV

Each State Party to this Convention shall, in accordance with its constitutional processes, take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition, or retention of the agents, toxins, weapons, equipment and means of delivery specified in article I of the Convention, within the territory of such State, under its jurisdiction or under its control anywhere.

In their September 22^nd joint statement to the Senate Homeland Security and Governmental Affairs Committee, Graham and Talent expressed their faith in the BWC:

While the treaty has some inevitable limitations—particularly the difficulty in detecting violators—it remains a powerful norm: no nation brags about their biological weapons capability. It is our obligation to strengthen this norm, internationally. Right now, the clock is ticking on the BWC—the next BWC review conference, in which every article of the entire treaty is reviewed, takes place in 2011. We must propose a new action plan for achieving universal adherence to the BWC, so that all nations of the world are signatories to this pact. We also need to promote new ideas for how the BWC may be implemented on a national level. This conference presents the United States with an opportunity to showcase the progress we have made here at home in both lab safety and lab security. We will have the opportunity to set the global standards of success.

Just as strategic nuclear reductions and declaratory policies made by individual nations help to solidify the nuclear nonproliferation norm, actions taken by individual nations to ensure the safety, security, and legality of domestic biological research help to solidify the biological nonproliferation norm.  Bills like the recent Lieberman-Collins proposal are vital to transforming the BWC into a robust and healthy international regime.  Sen. Lieberman shared Graham’s and Talent’s broad vision, saying, “We hope that this proposal embracing the recommendations of the Graham-Talent commission will set an international standard for biosecurity.”

Meanwhile, the U.S. is not the only entity contributing to international action.  For example, the Australian Parliament adopted legislation for stricter biosecurity practices this past September.  And yesterday, the UN Headquarters in New York hosted a special event entitled “Resolution 1540: At the Crossroads” that brought together experts from academia, NGOs, and industry to review states’ responsibility under Resolution 1540.  Based on the resolution, “all States shall take and enforce effective measures to establish domestic controls to prevent the proliferation of nuclear, chemical, or biological weapons and their means of delivery, including by establishing appropriate controls over related materials.”  At least three papers were presented that focused exclusively on biological issues.  This included a paper by Dr. Marie Isabelle Chevrier of the BioWeapons Prevention Project, which endorsed greater government and UN engagement with civil society groups for help “in monitoring and raising awareness of the norms against the weaponization of disease.”

Concluding Thoughts

It is in the interest of every nation to pursue a strong set of biosecurity prevention and preparedness measures for two important reasons.  First, as explained above, domestic action on the part of individual nations goes a long way in contributing to the nonproliferation regime, thereby decreasing the risk of an attack occurring in one’s own homeland.  Second, given the modern mobility of people and infectious disease, a biological weapon attack occurring anywhere presents a subsequent threat to the rest of the world.  This renders national and international interests as one and the same—and this applies to both nefarious and natural biological threats.

As previously articulated, the volume of visible activity in the biosecurity movement over the past few months is encouraging.  It may not be at the head, but bio is certainly at the international table of nonproliferation discourse.  Biological threat issues still require a greater influx of creative minds and active awareness.  For this reason, Dr. Chevrier’s paper, and the BioWeapons Prevention Project as a whole, are particularly interesting.  Ultimately, these issues must come to the forefront of public awareness before breakthrough progress can be made.

In our world of nuclear headlines, biological threat issues continue to get very little relative attention from the media, public, and government.  Nuclear weapons certainly pose a very, and viscerally, immediate threat.  Their very physical existence poses tremendous risks regardless of who controls them.  On top of that, there may be nothing more popularly terrifying than nuclear weapons in hands of ‘rogue’ states and terrorist organizations.  Nonetheless, many within the nonproliferation world have dedicated themselves to the less-known but emerging biological threat.  Although the public today is much less interested than it had been during the heights of the Cold War, the controversies over Iran’s and North Korea’s nuclear programs have caused nuclear nonproliferation and nuclear terrorism discourses to increasingly register in the public consciousness.  However, the public has not gotten very far down the road of engagement with bioterrorism discourses.  Since the Amerithrax letters in 2001, the government has dramatically bumped up spending for biosecurity and biodefense projects.  Nonetheless, there has been very little public engagement with these measures implemented by the Department of Homeland Security and Department of Health and Human Services.  This is incredibly unfortunate because the public could, in fact, benefit more greatly from understanding the nature of bioterrorism than from understanding nuclear terrorism.

The Prevention vs. Preparedness Dichotomy: Nuclear vs. Biological

As explained in last week’s post about infodemiology, there are two approaches to confronting the low-risk but high-impact threats, such as those presented by terrorist activities.  The first is prevention, which is aimed at identifying and thwarting the processes of the threat before the threat can actually materialize.  The second is preparedness, which assumes that a threat of this nature cannot necessarily be prevented and, thus, must effectively be dealt with after its materialization with the objective of mitigating the impact as fully as possible.

One of the Amerithrax Letters. The FBI alleges that Bruce Ivins, an American biodefense laboratory researcher, was the culprit behind these 2001 bioterrorist attacks.

The approach to the nuclear terrorism threat has focused on prevention—ensuring that fissile material, nuclear components, or entire bombs or warheads do not fall into the hands of terrorists.  Once a nuclear device is detonated, death and destruction are immediately felt, and there is little that can be done to mitigate effects after the fact.  Preparedness is certainly valuable, as moving people away from the direction of fallout would save lives and protect health.  Nonetheless, the major damage is immediate, making prevention critical.  This focus on prevention is reflected in the centrality of the global nonproliferation regime, counterproliferation efforts such as the Proliferation Security Initiative and the Global Initiative to Combat Nuclear Terrorism, and comprehensive bilateral efforts between the U.S. and Russia to secure loose fissile material and nuclear components throughout all the ex-Soviet territories.

In contrast, the approach to bioterrorism has revolved around preparedness, reflected most specifically by President Bush’s Project BioShield and Project BioWatch.  There are a few reasons for this difference of approach.  The first is the tremendous difficulty involved in monitoring, securing, and controlling biological materials (pathogens) as opposed to fissile materials.  As pointed out in an earlier post, biological sciences are simply more prolific and easier to pursue than nuclear physics, all countries have the right to research and have better access to research in the biological sciences, and the pursuit of understanding and improving human health is culturally more entrenched worldwide.  Moreover, hazardous biological materials can be found in nature—and they are capable of self-replication in nature.  Thus, if terrorist organizations desire to do so, it may be incredibly easy for them to acquire hazardous biological agents.  Below is a table included in an article by Dr. Jonathan B. Tucker, Senior Fellow and biological and chemical weapons expert with the James Martin Center for Nonproliferation Studies, which lucidly outlines the differences between fissile and biological materials:

Keeping hazardous biological materials out of the hands of terrorists is a virtually impossible task, thus leading to a greater focus on preparedness biosecurity strategies.

On his change.gov website, President Obama had pledged to “strengthen U.S. intelligence collection overseas to identify and interdict would-be bioterrorists before they strike,” thereby adding to the prevention approach.  A recent White House bioterrorism meeting confirmed this intention; reporting by the NTI’s Global Security Newswire indicated that the focus was on the prevention of biothreats rather than crisis management.

Nonetheless, President Obama on change.gov also indicated that he would continue and strengthen the already established preparedness campaign by “Build[ing] Capacity to Mitigate the Consequences of Bioterror Attacks,” “Accelerat[ing] the Development of New Medicines, Vaccines, and Production Capabilities,” and “Lead[ing] an International Effort to Diminish Impact of Major Infectious Disease Epidemics.” Preparedness techniques help against both naturally occurring epidemics and bioterror attacks, and every indication points to the fact that President Obama, like President Bush, believes in the fundamental need for preparedness vis-à-vis bioterrorism.

In addition to the tremendous difficulty involved in monitoring, securing, and controlling biological materials, the nature of the biological threat also alters the distinction between prevention and preparedness techniques.  In fact, because of the properties of biological threats (pathogens), preparedness is uniquely a form of prevention in the biological realm.  Bob Graham and Jim Talent, chairmen of the 2008 Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, explain this relationship in an article in the most recent issue of Biosecurity and Bioterrorism:

The Report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism

There is, indeed, a great deal of work to do, but biological weapons give the good guys opportunities that nuclear weapons don’t: a biological weapon can be prevented from causing mass lethality after an attack. This cannot happen after a nuclear detonation, but it is theoretically possible to significantly limit the loss of life after the deliberate infliction of disease. It may be an expansion of what is normally thought of as prevention, but it capitalizes on the unique traits of biology. There may be a time period after an attack when a prepared, efficient response could limit the size and scope of the attack by orders of magnitude. A well-prepared nation can use the incubation period of a disease-causing agent to its people’s advantage.

In the biological realm, a focus on preparedness is not simply a half-hearted, lazy attempt to protect the population.  Instead, it is indeed a form of prevention—prevention not necessarily of the hypothetical attack, but prevention of the consequences of that attack.  The luxury of this approach does not exist in the nuclear realm.

True Preparedness Involves Public Action

A post last week made the argument that a truly effective infodemiological program would need to involve public engagement.  That argument is extended here: a truly effective program of preparedness against bioterrorism involves public engagement.  In order for the preparedness-prevention capability described by Graham and Talent to work, in addition to the development of medical countermeasures, those medical countermeasures must be distributed (1) quickly, (2) widely, and (3) smoothly in the immediate wake of an attack.  The countermeasures are useless unless used on an individual basis in a timely manner.

Quick distribution is achieved through rapid identification of an attack.  This requires effective monitoring on all levels of the public health system as well as biological agent detectors, such as those of Project BioWatch.  Thus, this first criterion is resolved through institutional and technical fixes, both of which can continue to be improved.  For example, the detectors currently in place under Project BioWatch cannot detect for the almost infinitely wide range of pathogenic threats.  Undoubtedly, detection technology will continue to improve and solidify capacities for rapid identification of an attack.  Wired’s Danger Room and Popular Mechanics each have recent articles illustrating the progress promised in this area by metamaterials and nanotechnology.

Wide distribution is achieved by an effective mechanism of distribution.  This is a product of logistics.  Somehow, medical countermeasures need to get from their preliminary location and into the hands of individual people in order for preparedness-prevention to be achieved.  Over the past eight years, authorities have considered ways in which to accomplish this.  Currently, one of the leading plans is to utilize the Federal Postal Service to strategically deliver countermeasures according to pre-planned routes while encouraging private citizens to remain in their homes and patiently await deliveries.

According to a 2008 New York Times profile of the new plan—which has been designed specifically with an eye toward what the authorities consider the most likely bioterrorist attack, an anthrax attack—at least 72 major cities have adopted this strategy and devised plans to deliver prophylactic antibiotics in the case of an anthrax attack.  The strategy has shown to be remarkably superior to the past approach:

The traditional approach to dispensing medical supplies to a large population is to place the medicines in schools and other public places and instruct people to pick them up. The main shortcoming of this “PODs” approach (for “points of dispensing”) is labor: there are not enough public health workers to distribute the antibiotics quickly, and cities would have to rely largely on volunteers to perform unfamiliar (albeit simple) tasks in unfamiliar settings. A better way is to let residents stay home and have mail carriers, escorted by police officers, go door to door delivering antibiotics. This can be done within eight hours, trials in Seattle, Boston and Philadelphia have shown.

Though designed specifically as a counter to an anthrax attack, this strategy can certainly be applied to bioterrorist attacks using other biological agents.

Perhaps the most difficult, uncertain, and least considered criterion is the third: smooth distribution.  Technical, institutional, and logistical planning can certainly be complex, but are afforded with technology, bureaucratic structure, and contingency awareness that ensure efficacy.  On the other hand, planning to deal with potentially chaotic social dynamics is quite another task.  In the wake of a bioterrorist attack, it would be reasonable to expect a breakdown in social order, even before symptoms begin to set in on a large scale.  Overrunning of health facilities, a mass exodus out of the victim city, and activities like looting that are characteristic of social disorder would be all be potential consequences.  In such an atmosphere, how do the authorities implement their well-crafted strategy?

The key is public cooperation during the post-attack process.  And the only way to ensure cooperation during that process would be to inform and prepare the public in advance for this hypothetical misfortune.  The New York Times explains that “Mathematical models suggest that such a well-executed and well-supplied approach to delivering antibiotics would result in half the number of deaths as would occur using the traditional PODs approach.”  However, without smoothness of distribution—that is, without cultivating public cooperation during the process—any sort of advantage presented by the new distribution strategy would be made negligible, and ultimately, the entire ordeal would likely be unsuccessful depending on the magnitude of social disorder.  This chaotic situation could be averted through pre-planned public engagement.  The public must be made aware of the hypothetical threats, the epidemiological properties of those threats, the planned preparedness-prevention strategy, and the rationale for that strategy.  The public must be made aware that the authorities’ plan is, indeed, in their best interest.

Promoting Public Cooperation

This sort of awareness does not require an incredibly in-depth or esoteric scientific understanding.  Science can be complex, but it is easily translated into all levels of lay language.  Right now, there are serious information gaps throughout the public, partially having to do with insufficient public outreach by the authorities, and partly with public apathy.  How can those information gaps be filled in?  The public cannot simply be forced to sit down and study the information pertinent to a bioterrorist attack—an event that may very well never occur in individual cities.

But this task does not necessarily require a methodical campaign of public education.  Instead, small-scale actions could be taken to promote an overarching culture of responsibility and awareness that would contribute in the end to organically smooth implementation of bioterror preparedness-prevention strategies.  For example, measures could be taken to promote greater access to the pertinent information on the internet, there could be greater media coverage, and acknowledgement of the threats and instruction could be provided in school classes.  Individually, each one of these things may not amount to much.  But as a collection of mutually reinforcing elements, they would form a cultural “web of significance” effectively enforcing smooth public handling of a bioterrorist attack.

On Wednesday, Michael E. Ruane of The Washington Post published an article entitled “Flu Trackers Encourage Patients to Blog About It,” describing public health agencies’ growing use of the internet social interactions to track flu outbreaks.  This has been made particularly relevant today as a result of H1N1 fears, but this type of internet monitoring (part of the rubric of “infodemiology”) has not popped up as a result of H1N1.  Ruane’s article is significant in that it is a small step towards popularizing the term “infodemiology” in mainstream consciousness, which could in the future present invaluable assistance to the public health and response system.

However, the infodemiology world could greatly benefit from a slight transformation: it should increasingly promote active citizen participation.

The Rise of Infodemiology

The term “infodemiology” was coined in a 2002 American Journal of Medicine editorial entitled “Infodemiology: The Epidemiology of (Mis)information” by Gunther Eysenbach, MD, a health policy professor at the University of Toronto.

In a later article, Eysenbach more lucidly explains infodemiology:

Dr. Gunther Eysenbach

Infodemiology can be defined as the science of distribution and determinants of information in an electronic medium, specifically the Internet, or in a population, with the ultimate aim to inform public health and public policy.

Potential infodemiology indicators and metrics include automatically aggregated and analyzed data on the prevalence and patterns of information on websites and social media; metrics on the “chatter” in discussion groups, blogs, and microblogs (eg, Twitter); and activities on search engines, etc.

…infodemiology is rooted in the idea that—at least for some areas and applications—there is a relationship between population health on one hand, and information and communication patterns in electronic media on the other, and if it were possible to develop robust metrics or “infodemiology indicators” which reflected these information and communication patterns in real-time, then all kinds of useful public health applications could be developed.

Eysenbach traces infodemiological studies back as far as 1996, but the term has yet to truly enter into mainstream consciousness.

Google’s Flu Trends and Boston-based HealthMap are two examples of current, public-access infodemiological systems.  Flu Trends monitors google search queries (locations and volume) with the assumption that there is a correlation between searches and experience of symptoms.  HealthMap crawls the internet looking for relevant epidemiological information, and consolidates that information into a real-time mapping interface.

Passive Participation

Most infodemiological techniques only involve citizens passively.  They certainly require alertness on the part of citizens, but do not necessarily solicit action on the part of citizens.  Instead, they monitor the public’s web presence looking for signs of increased interest in illness without most individuals actually being aware that this is happening at all.  The Washington Post article quotes Alessandro Vespignani, professor of informatics at Indiana University, explaining the concerns of this type of monitoring:

The Internet has been . . . a major scientific revolution… [With] all huge scientific revolutions there are enormous potential dangers. And confidentiality, privacy, is probably the first major issue at stake here.

Privacy is a contentious concern because of the status of citizens as unknowing (and by extension, perhaps unwilling) in regard to being monitored.

A Screenshot of HealthMap

There is a simple solution that would overcome the privacy problem while, even more importantly, greatly strengthen the efficacy of infodemiology: active and cognizant citizen involvement.  Instead of simply being the objects of monitoring, citizens can also become individual protagonists in helping a vast health network to confront and prepare for threatening epidemics.  As Ruane explains, some infodemiological programs already utilize active citizen help, such as Maryland’s “Resident Influenza Tracking Survey,” which requires citizen volunteers to fill out weekly surveys.  However, as August 2009, only 740 people had signed up in Maryland.

Greater efforts to bring responsible individual citizens actively into the contemporary challenges of infectious diseases will not only contribute to the public health battle against naturally occurring epidemics, but will also help to defend against potential bioterrorist attacks.  Infectious disease tracking is made quite complicated by unpredictable social interactions.  Real-time information provided to a consolidated infodemiological public health network would make tracking and preparedness much more reliable, and could thus save countless lives.  And in the case of a bioterrorist attack, rapid and real-time information would be even more critical to save lives and to maintain social stability.

The Preparedness Campaign

In Biosecurity Interventions: Global Health and Security in Question, sociology professor of UC Berkley Andrew Lakoff  discusses a transformation occurring within national security doctrine.  As Lakoff explains, in contrast to the traditional approach of dealing with preventable risks, U.S. government institutions now increasingly model risk management strategies around a postmodern, ambitious, and formalized agenda of preparing for (and thus mitigating) unavoidable risks.

These unavoidable risks come in two categories.  The first type of risk is man-made.  The power of modern science and technology—most archetypically represented by nuclear physics—has resulted in the simultaneous potential for remedial and destructive effects.  German sociologist Ulrich Beck has coined the term “manufactured risks” to refer to the unintended consequences of modern progress (Ulrich Beck, World Risk Society, 1999). The second type of risk is natural.  These risks, such as environmental disasters and natural disease epidemics, are beyond human control.  The threat of bioterrorism spans across both types of risk.

The agenda of preparedness has become as, if not more, important than the agenda of prevention.  Lakoff refers to this strategy as “vital systems security” and explains that

…this form of security is oriented to a distinctive type of threat: the event whose probability cannot be calculated, but whose consequences are potentially catastrophic. (Lakoff 2008: 403)

These threats cannot be effectively measured, and our means of knowing if and when they will transpire are exceptionally limited.  The justification for expending incredible amounts of time and money to establish preparedness against these risks lies in their “catastrophic” nature.

It is in this vein of preparedness that the Bush administration, in the wake of the September 11^th and consequent anthrax letter attacks, decided to bulk up its spending on biodefense.  On June 12, 2002 during a live televised address, President George W. Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), stating:

Bioterrorism is a real threat to our country. It’s a threat to every nation that loves freedom. Terrorist groups seek biological weapons; we know some rogue states already have them…It’s important that we confront these real threats to our country and prepare for future emergencies.

According to a 2008 article from The Washington Post, from 2002 to 2008, over $57 billion was spend on the U.S. biodefense program.  Most of this spending went to preparedness approaches, such as the production and stockpiling of vaccines and drugs (Project BioShield), the establishment of a network of detectors in more than 30 American cities (Project BioWatch), and training for mass infection and casualty response.

It has recently been contended that in contrast to the previous administration, the Obama administration plans to focus more greatly on prevention efforts.  Global Security Newswire reported on a recent White House bioterrorism meeting, in which the focus was on the prevention of biothreats rather than crisis management.

However, this does not mean that the importance of preparedness will be neglected.

Moreover, as evidenced by infodemiological programs, the preparedness culture seems to be spreading into a new realm: public awareness.  Preparedness does not need only include an expensive vaccine production industry, state-of-the-art biomonitoring equipment, and recondite hospital protocols.  Preparedness need not only originate in government programs and related industry.  The preparedness agenda can, perhaps most effectively, benefit from the most abundant and powerful source: individual citizens.

The Role of the Citizen

The most recent report by the Congressional Commission on the Prevention of WMD Proliferation and Terrorism, entitled World at Risk, emphasized the power of importance of citizen involvement:

A well-informed and mobilized citizenry has long been one of the United States’ greatest resources.  While much of this report has focused on what the U.S. government much do to prevent the use of weapons of mass destruction, it is also important to recognize the contribution that all Americans can make in preventing such an attack against our country. (pg. 108)

Although the report does not discuss infodemiology, its tone and recommendations for the “role of the citizen” is directly relevant to infodemiological potential.  The national (or even global) cyber-info community can help to overcome the effects of epidemics, whether naturally or nefariously caused.  Engaged online communities can help to defeat terrorism.  However, at this point, as explained above, infodemiological systems have not fully capitalized on the role of active, engaged citizens; instead, they have focused on the perhaps more convenient route of utilizing the public’s passive web presence.  Both types of engagement must be pursued.

But in order to get to the point where the public can better help the government defend against these types of hazards, many things need to happen to also help the public toward that end.  For example, there must be more public information published that explains the properties of specific threats, what constitutes suspicious activity, and how to inform authorities.  The public and government must more intimately engage each other in an information-sharing partnership.

But Beware of Misinformation and Disinformation

As indicated by the term, infodemiology demands information—real-time information.  This is its source of greatest strength, but also a troubling source of vulnerability.  In a study on the reliability of infodemiological practice for the American Medical Informatics Association, Eysenbach concluded:

Systematically collecting and analyzing health information demand data from the Internet has considerable potential to be used for syndromic surveillance. Tracking web searches on the Internet has the potential to predict population-based events relevant for public health purposes, such as real outbreaks, but may also be confounded by “epidemics of fear”.

Although Eysenbach has identified infodemiology as having “considerable potential,” he also notes that its efficacy can be greatly undermined by misinformation.  As described above, one type of misinformation would be the result of fear, which would confound the vision of infodemiological programs.

Another type of misinformation not covered by Eysenbach could come from intentional interference (disinformation).  Pranksters, hackers, and general rabble-rousers could exploit infodemiological systems as tools of disruption, purposefully inputting false information that would result in mis-diversion of public health resources and attention.

Ruane of The Washington Post quotes Ashley Fowlkes, an epidemiologist with the CDC, saying:

You’re always going to have to have [infodemiological results] verified against a system that’s physician-based.

Cross-referencing of different public health tools such as described by Fowlkes would certainly mitigate the dangers of infodemiological disinformation.  Nonetheless, as infodemiological systems become more powerful and involved, information-reliability safeguards of some sort may have to be built in.

Concluding Thoughts

Moving towards an infodemiological model that incorporates a more active citizenry (as opposed to the currently passive use of citizens) would have several benefits:

1. Infodemiological programs would produce a greater wealth of more reliable information;
2. Individual citizens would be exposed to the importance of responsible involvement in communally defending against infectious disease; and
3. As an extension, individual citizens would be introduced to their own potential in defending against terrorism

Although it is the official job of the government, the citizenry should also try to take more active role in protecting itself.  Through partnerships between citizens, the public health system, and the government, 21^st-century biological threats will be significantly mitigated.  And the lessons learned could be applicable to other types of threats as well.

Within the life sciences curriculum of colleges around the world exists an exigent academic gap.

History has exemplified the imperative for science scholars to contemplate the ethical, social, and political implications of their disciplines.  Max Weber characterized the traditional scientific ethos in his description of science as an isolated value sphere, one that should not be coupled with ethics and politics.  J. Robert Oppenheimer, father of the atomic bomb, exemplified this Weberian spirit in his contention that “the true responsibility of a scientist, as we know, is to the integrity and vigor of his science.”  However, after the use of the atomic bomb, the tremendous culpability felt and expressed by many of the Manhattan Project scientists, including Oppenheimer as well as Robert R. Wilson, signaled the rise of a new scientific ethos, one that cultivates an ethically, socially, and politically responsible self-identity for the scientist and science scholar.  At this nexus between science and responsibility lies the curricular gap of life sciences programs.  I write to you in the spirit of the new scientific ethos with the express purpose of recommending that you include the 1972 Biological and Toxin Weapons Convention (BTWC/BWC) as a mandatory component in the curriculum of undergraduate programs pertaining to the life sciences.

It should be incumbent upon institutions of higher learning—charged with the task of creating individuals who are simultaneously astute authorities of their fields and responsible citizens of the world—to inculcate their science scholars with a socially, politically, and ethically responsible ethos.  Equipped with this holistic approach, these scholars will be properly prepared to go forth and conscientiously implement their powerful knowledge while guarding against dangerous misuse or nefarious exploitation of this knowledge.  In the life sciences, this ethos involves legal responsibility: the BWC is an international legally binding treaty that has been signed and ratified by our nation.  In light of the notorious dual-use dilemma of the life sciences, a large cohort from the international science community united with policymakers and diplomats have in the past two decades increasingly voiced deep concerns over irresponsible decision-making that is at odds with the obligations and objectives of the BWC.  They have declared the need to institute a global culture of bioethics, awareness, and codes of conduct.  Industry’s control over the life sciences continues to rise, and many worry about the possibility for advertent and inadvertent social, political, or physical damage as a result of reckless science—that is, science exclusively concerned with raw technical and industrial advances at the expense of considering its potentially problematic effects.

The BWC provides a foundational framework within which these dangers may be mitigated, but the BWC by itself is insufficient for executing such a formidable task.  The life sciences disciplines and industries cannot be dealt with as a single, autonomous organism.  Ultimately, individual people making individual choices on a daily basis determine the trajectory of the life sciences.  Thus, in order to achieve efficacy, the BWC must be applied and demonstrated on the basis of the individual scientist.  Moreover, a common grievance concerning the BWC is its lack of a verification protocol.  This unfortunate deficiency, whether a result of verification being impracticable or a result of complex politics, also places greater accountability and responsibility for compliance on individual states and individual actors within those states.  To comprehensively ensure compliance with the BWC and foster a conscientious eye toward maintaining global safety and security, individuals (in addition to governments) must be directly exposed to the material of the BWC.  Institutions of higher learning are the ideal setting in which to propagate this vital exposure.

We live in a world that has identified the need for comprehensive safeguards against harmful research, both advertent and inadvertent.  The BWC is the locus of these safeguards in the life sciences.  The scientist proponents of international bioethics are attempting to proliferate the new ethos of moral, political, and social responsibility in advance so that they will not, as nuclear physicist Robert Wilson did, have to repent:  “Thinking back to that time, it occurs to me that it would have been an excellent occasion for the conscience of a scientist to have been exercised.”  I entreat you, form your institutions into exemplars of progressive and ethical life sciences scholarship; infuse values of law, civility, and humanity into all disciplines; and ensure that your colleges provide its life sciences scholars with all the knowledge and understanding necessary to pursue the true goal of science: to advance the well-being of society and of the world.  Establishing the BWC as a mandatory life sciences curricular component is absolutely pivotal to this bioethical imperative.

Sincerely,

Weapons and Hope

Another troublesome element of the biological dual-use dilemma, which I did not develop in my earlier post here, is the possibility of dangerous international competition.  National research agendas, aimed at maintaining technological parity or advantages, could push the pace of advancements in the biological sciences at an incredible speed, perhaps thrusting research programs into areas that would otherwise be designated off-limits.

Such a situation is complicated by inconsistencies in international standards for research, which could be the result of two things.  The first would be intentional decisions on the part of individual nations to disregard the terms of the Biological Weapons Convention (BWC), which could prompt other nations to follow suit.  The second is a cultural issue: the lack of global cultural standards on what should and should not be permitted, particularly as advances are made in biotechnology and synthetic biology.  A global scientific culture of responsibility is vital, but it is unclear how consistently such a “culture” manifests itself into standards around the world.  The BWC is somewhat ineffective on many levels because of the vagueness of what exactly is illegal vis-à-vis the dual-use dilemma and the lack of a verification protocol.  These complicated shortcomings in the BWC have led to divisive issues surrounding biodefense programs, and may lead to similar dynamics surrounding biotechnology in the future.

The Biodefense Transparency Problem

In line with the dual-use dilemma, biodefense programs involve many of the same types of technologies and materials that a nefarious biological weapons program would involve.  Biodefense programs study and experiment with dangerous pathogens, sometimes they may genetically alter pathogens, and sometimes they may experiment with aerosolization—these are some of the primary earmarks of an offensive biological weapons program.  However, in biodefense, all of these activities are performed with the final purpose of developing countermeasures and therapeutics.  Nonetheless, it is not necessarily clear to outside observers that these biodefense programs are involved exclusively with biodefense goals.  In fact, the U.S. is suspicious that several countries may be developing offensive biological weapons under the disguise of biodefense, pharmaceutical, or life sciences research programs because of research elements that appear to have pertinence to offensive biological weapons capability.  As articulated by the U.S. Department of State Compliance Report of 2005, the U.S. suspects this may currently, or in the past, be the case with the following countries: China, Cuba, Iran, Iraq, Libya, North Korea, Russia, and Syria.  However, the U.S. itself has the most far-reaching and comprehensive biodefense, pharmaceutical, and life sciences research programs in the entire world.  In an interview on Wednesday with the Nuclear Threat Initiative, independent analyst Gerald Epstein indicated that the U.S. is “by far the most transparent on [bio]defense issues.”  See here.  Nonetheless, the U.S. certainly does have many research elements, such as those described above, that could be considered from the outside as pertinent to an offensive biological weapons program.  Can we expect other countries to not have the very same suspicions of us?

Domestic Suspicions Emerge

On November 25^th, 1969, Richard Nixon’s made an unprecedented announcement, unilaterally renouncing biological weapons and thereby leading to the first ban in history of an entire class of weaponry.  In his speech, Nixon explained:

Biological weapons have massive, unpredictable and potentially uncontrollable consequences. They may produce global epidemics and impair the health of future generations. I have therefore decided that:

• The United States shall renounce the use of lethal biological agents and weapons, and all other methods of biological warfare.
• The United States will confine its biological research to defensive measures such as immunization and safety measures.
• The Department of Defense has been asked to make recommendations as to the disposal of existing stocks of bacteriological weapons.

Prior to Nixon's announcement, Fort Detrick was the center of the U.S. offensive biological weapons program

Nonetheless, despite the U.S. founding and maintaining unflagging commitment to the BWC, suspicions of an offensive biological weapons program continue to exist in our society.  The extent of these suspicions became very clear during my thesis research on the political controversy surrounding a high-containment biodefense laboratory complex recently constructed in Boston—the National Emerging Infectious Diseases Laboratories (NEIDL), operated by the Boston University Medical Center and funded in large part by the National Institutes of Health.

The controversy has become an extremely complicated struggle between different interest groups that straddles a wide variety of political and social dynamics.  However, the foundation of the controversy, its raw fuel, revolves around the hypothetical risk that situating this particular laboratory (a Biosafety Level 4 facility) poses to the surrounding community.  The conceptually precarious nature of the NEIDL’s research agenda, characterized by its uppermost biocontainment classification of Biosafety Level-4 (BSL-4), serves as the primary stimulus for disagreement and dissent over both the hypothetical impact and underlying purpose of the NEIDL.  The beneficence of the NEIDL’s intended research has been questioned.  Discourses and ideas within the NEIDL controversy show that the NEIDL’s research agenda and the BSL-4 status are understood not only within their scientific context but also within a cultural context of connotations, experiences, and beliefs held by members of society.  This interconnected web of meanings has led many within the anti-NEIDL opposition group to contend that the NEIDL will undertake biological weapons research.

In formulating ways to institute an effective biodefense program for the nation, U.S. policy-makers have identified the need to implement a fusion of national defense and public health approaches.  However, this fusion, although seemingly suited to the intricate challenges presented by biological weapon and biosecurity threats, has resulted in its own shortcomings for the biodefense program.  Renowned journalist Laurie Garrett describes the contact between these two different institutional cultures, that of national defense and that of public health, as a “conflict of interest” that jeopardizes society’s trust in the public health system’s openness and beneficence:

But the fear of bioterrorism threatens to destroy that vital social contract, which is not shared by law enforcement and defense officials. The closer a public health system draws to the other two systems, the greater the danger that it will lose credibility in the eyes of the public… Some public health advocates are convinced that no marriage between their profession and law enforcement could ever work and have denounced all efforts to heighten concerns about bioterrorism. (Laurie Garrett, 2001, “The Nightmare of Bioterrorism”, Foreign Affairs 80(1): 76-89.)

In the eyes of the anti-NEIDL community, the NEIDL lacks credibility as a safe and integral component of the public health system—it undermines the “vital social contract” of public health—because of its association with a federal, national defense agenda.  Criticisms of the NEIDL’s development end up going beyond the alleged compromise of openness and transparency.  The NEIDL’s connection to national defense and homeland security, which is represented by both its official mandate and its funding from the NIH through a targeted Homeland Security budget, has incited a pervasive accusatory paranoia about biological weapons research, particularly amongst citizens who are cynical and disdainful of the Bush administration’s record.

In an attempt to understand and mitigate public opposition to the NEIDL, the NIH established a Blue Ribbon Panel.  The following is an excerpt taken directly from the 14 October 2008 Blue Ribbon Panel public community meeting in one of the Boston neighborhoods bordering the NEIDL:

Adel Mahmoud, Chairman of the Blue Ribbon Panel: This question has been on the minds of everybody and in Boston, and I want to respond to it.  And hopefully we are responding according to the laws of the country; we are not making a story.  The development of bioweapons is forbidden by the United States and international law.  This is the law.

Audience members laugh mockingly.

Now you can laugh, and I can laugh back at you, but that’s not the issue.  The issue is, do we live in a country that has got laws that are respected or not?

Audience: No!

You need to give me the courtesy to complete my answer, just as I give you the courtesy to say your questions, ok?  Anyone who develops bioweapons can be subject to criminal prosecution in keeping with those laws and restrictions.

A member of the audience verbally mocks Mahmoud.

I really don’t appreciate that, I really don’t appreciate it.  Boston University has publicly pledged that research on bioweapons will not take place at the NEIDL.  Furthermore, bioweapons research is very different than biodefense research.  Bioweapons research involves the development or production of biological agents or toxins for use as weapons.  Please try to appreciate this definition.  Biodefense, on the other hand, involves the development of protective interventions…I really, really plead with you to try to appreciate the difference between those two because if we continue on the same six years of debate, we’re not going to get anywhere.

The NEIDL in Boston

The pro-NEIDL interest group and many experts on the issue do not believe such accusations to be credible.  But regardless of its level of validity, this argument has become an unyielding element of the NEIDL controversy; that bioweapons research will occur in the NEIDL is a perceived reality for many people observing the NEIDL’s development.  Compliance and noncompliance with the BWC is a matter not only of practice but also of perception.  This is the case for domestic audiences, as well as for foreign nations examining one another.

Fears of a Biological Arms Race

Several experts on the matter have asserted that the biodefense research, with its focus on national defense, creates the precarious possibility of a foreign bioweapons arms race as foreign nations will also perceive biodefense facilities, such as the NEIDL, as bioweapons development facilities.  This includes Boston University School of Public Health Professor Dr. David Ozonoff and medical anthropologist Jeanne Guillemin, both of whom have been very involved in the NEIDL political controversy and in biodefense discourses in general.

Despite controversy surrounding any single particular laboratory, biodefense research will continue in the U.S., whether in university laboratories or government laboratories.  It is difficult to gauge just exactly how real the threat of bioterrorism or use of biological weapons actually is, since we do not have full access to information on the capabilities and intentions of terrorist groups and foreign governments.  However, it is perfectly clear that technically feasible use of biological weapons could result in horrific and catastrophic losses of life and social stability.  Biological weapons could theoretically also be deployed as genocidal weapons.  In this scope, biodefense seems perfectly warranted despite the concerns surrounding it.

Thus, there is a tremendous need for transparency and accountability in biological research programs around the world in order to mitigate mutual suspicions and prevent a competitive, self-perpetuating biological arms race.  The Center for Arms Control and Non-Proliferation has identified this challenge, expressed in a report (released yesterday) that explains the need for more effective compliance processes.  The report was the result of a “meeting, held in Washington, DC on 25 February 2008, [that aimed] to facilitate information sharing and discussion among a small group of governmental and nongovernmental experts about the processes used by various governments and government agencies to ensure their compliance with the BWC.”  The underling significance of the report is its contributions to the understanding of how to strengthen compliance with and confidence in the BWC.

There are several things about the BWC that are important to keep in mind when considering how to implement compliance:

1. The standards of the BWC may be interpreted vaguely, with intention being extremely important in the determination of what is legal and what is not legal
2. Lack of a verification protocol and lack of clear, automatic consequences of noncompliance has made the BWC a treaty of norms, requiring the building of credibility and confidence between nations, and revolving around perceptions
3. The ultimate intent of biological research programs is impossible to know definitively

The Center for Arms Control and Non-Proliferation report discusses the compliance procedures in place for several countries as well as delving into the challenges to credibility of the BWC.  The report expressed a general positive consensus among the meeting participants over two particular treaty interpretation principles:

The first principle was that compliance assessments should proceed from the presumption that biodefense activities must be shown to be justified under the terms of the BWC, rather than from the presumption that biodefense activities must be considered compliant unless shown to violate the terms of the Treaty.

and…

Second, it was proposed that in order to justify an activity under Article I.1 of the BWC, the activity should be shown to be both useful and critical for a prophylactic, protective or other peaceful purpose, the more so the greater the compliance concern.

A CDC Vaccine Researcher in a BSL-4 Laboratory

These two principles put the burden on individual countries to demonstrate they are in compliance, rather than putting the burden on others to prove individual countries are not are not in compliance.  There is a push to implement this approach for nuclear activities as well.  Although such an approach is not necessarily fair in terms of domestic civil punishment, this is a strong approach for an international treaty like the BWC, which tends to be based on normative action and mutual confidence and does not result in automatic punishment.  Such an approach promotes greater transparency and positive accountability, which are essential for mitigating the risk of a biological arms race.

A Trickier Future with Biotechnology

The BWC does not cover international competition in biotechnological research that does not deal with pathogens and toxins.  As discussed in my earlier post, the hypothetical threats of biotechnology include social hazards in addition to the physical hazards caused by pathogens.  The social hazards may expand into the international realm, particularly since, as already mentioned, there is a lack of global cultural standards on what should and should not be permitted.  Thus, one nation’s standards, and attempts to prohibit seemingly socially divisive or risky technologies, would not necessarily be followed by other nations.  How would one nation respond to a second nation pursuing cutting-edge biotechnological research that the first nation had decided was too ethically and socially sensitive to pursue, particularly if this research could present some sort of economic or even military advantage over the first nation?  National security, economically and militarily, are topics that often trump all other arguments.  The concept of morality and social stability often seem too abstract and impractical to focus on in the minds of strategic policymakers.  Such a situation could undermine individual nations’ attempts to practice responsible and moderated biotechnological research.

On 19 June 2008, the House Committee on Foreign Affairs, Subcommittee on Terrorism, Nonproliferation and Trade held a meeting entitled “Genetics and Other Human Modification Technologies: Sensible International Regulation or a New Kind of Arms Race?”  One of the expert witnesses called for testimony was Jamie F. Metzl of the Asia Society.  Metzl explained that in the face of a country, corporation, or group moving forward with an aggressive program in a biotechnological field, particularly one that is socially and politically taboo (genetic enhancement, for example), others would have the choice of responding in four ways:

1. Doing nothing and accepting a deteriorating relative position
2. Beginning the same program in order to keep up
3. Working to halt the offending program
4. Seeking to develop a global governance structure to produce uniform conduct and application

Metzl supported the fourth choice.

Concluding Thoughts

Many consider nuclear weapons to be a paramount gauge of international eminence.  As the global disarmament agenda proceeds, and nuclear weapons are hypothetically abolished, what will take the place of nuclear weapons as a measure of international status?  Biotechnological capabilities are certainly a possibility, and it could be a possibility equally as dangerous as nuclear weapons.  The nuclear and biological technologies have many differences and their uses in society include distinct contexts.  Nonetheless, as biotechnology, synthetic biology, nanotechnology, and even robotics continue to advance at an explosive pace, lessons learned from the international nuclear voyage can certainly be applied so that the general challenges and dangers presented by nuclear weapons can be prevented in these other fields of science before they even arise.

The Problem of Viral Mutation

H1N1 Influenza Virus

One of the truly frightening features of viruses is their tendency to mutate into new strains, which can often yield new properties of transmissibility and virulence.  This is a prime consideration that has led to the incredible hype surrounding the new H1N1 influenza strain.  The scientific community has expressed fears that H1N1, which currently seems no more serious than a seasonal flu strain, may be in the process of mutating into a serious pandemic virus.  Public health officials have made analogies to the 1918 Spanish flu, which is believed to have followed this course of mutation over the summer (though there is some debate surrounding this claim, which can be seen here).

As is described in another post today, there are also fears that rogue, terrorist, or careless scientists could engineer new strains of viruses.  New Scientist quotes Michael Goldblatt of Functional Genetics as he explains the problem of emerging viruses:

If you look at the viruses that are the biggest threats of modern times, most of them were unknown through human history: HIV, SARS, Ebola. You don’t know where the next one is coming from. How do you develop therapeutics for the unknown and unknowable, given that you won’t have time to develop a vaccine for a new agent after it appears?

Goldblatt’s question is rhetorical, as his research team at Functional Genetics as well as a few other groups now may have an answer.

A New Approach

New Scientist explains the conventional approach to antiviral drugs:

The conventional strategy for developing antivirals is “one bug, one drug” – finding a drug that blocks viral replication by binding to part of a viral protein. The trouble is, any minor mutation that slightly changes the shape of the protein can render these drugs useless, as is happening with Tamiflu. The hundreds of millions of dollars governments worldwide have spent stockpiling this drug could well turn out to be futile.

TSG101, one of the proteins targeted by Goldblatt's team

In contrast, Goldblatt’s team is not targeting viral proteins.  Instead, they are targeting host (human) proteins.  Even at the most basic levels, molecular biology courses teach students that viruses hijack host cells not only through synthesis of their own viral proteins but also by co-opting host proteins.  Goldblatt’s team has developed new drugs that prevent viral replication by inhibiting specific host proteins needed by viruses to break out of host cells.  The results have been incredibly promising, with the drugs showing effectiveness against a wide range of viruses in a cell culture.  Moreover, targeting of host proteins should not pose a threat to normal cellular function (and thus human health); in fact, Goldblatt’s team has “identified more than 100 different human proteins that flu viruses need to replicate but which cells can survive without.”

Other research teams have shown positive results using similar approaches.  Under Vishwanath Lingappa, Prosetta Bioconformatics is developing drugs that target host proteins involved in the assembly of the viral protein coating, which is necessary for viruses to co-opt new cells.  Philip Thorpe of the University of Texas Southwestern Medical Center in Dallas is taking a slightly different approach, targeting a different host molecule.  With the help of Peregrine Pharmaceuticals, his team is developing a drug that will target a fatty substance that is normally only found on the inner surface of a cell membrane, but is found on the outer membrane when the cell is virally infected.  The drug is an antibody that binds to the exposed fatty substance, triggering the immune system’s destruction of the target cell.

Promises for the Future

It is still early for these host-targeted antiviral drugs, as only human trials will truly reveal if targeting host proteins and other host molecules results in serious side effects.  However, if the approach works, New Scientist explains that it would be “a medical breakthrough on a par with the discovery of penicillin.”  By targeting host molecules rather than viral proteins, these drugs would not only be able to immediately treat for new viruses but also mitigate the problem of viral mutations.

Read the article for a comprehensive look.