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The protection of US civilians against biological weapons attacks is an innovative government effort, accelerated by general fears of terrorism following 9/11. The 2001 anthrax postal attacks that followed soon after 9/11 prompted more funding for defenses against known select agents and also against new ones that might be developed. This new area of biomedical research is an important part of what is now referred to as “biodefense.”
“Bioterrorism”
generally refers to the potential use of dangerous disease agents against
civilian communities. These agents are often referred to as “select
agents” because they were investigated as weapons by scientists
working in biowarfare programs during the twentieth
century. The threat of bioterrorism has not been well defined, although
at various times in the last ten years government officials at the highest
level have emphasized its seriousness (1).
No actual bioterrorist event of serious proportions has ever taken place
in the US. In 1984, members of the Rajneeshee cult poisoned salad bars
in an Oregon community, in hopes of influencing local election results.
But no fatalities occurred and for a year, until a cult member confessed,
this attack was dismissed as the restaurants’ failure to maintain
sanitary standards (2). In 2001, the
five deaths caused by the anthrax letters were the inadvertent consequence
of anthrax spores leaking from their envelopes. While sometimes referred
to as bioterrorism, the seven or so letters are better described as biocrimes
(3).
The lack of catastrophic biological weapons use makes it difficult to estimate the scale and nature of appropriate defenses against bioterrorism. How any community would react to a bioterrorism event is also open to speculation. Yet many scenarios have been composed as a way to plan national and local community response. These scenarios rely on past disease infectious outbreaks not caused deliberately, such as epidemics of plague and smallpox. They also rely on an unusual accident that took place in 1979, in the Soviet city of Sverdlovsk. There an anthrax aerosol was accidentally released from a military facility and killed some 70 people (4).
It may be that one or more terrorist groups have the intent to move beyond conventional explosives and military weapons to weapons of mass destruction, including nuclear, chemical and biological weapons. For biological weapons, the presumption has been that they are easier to make or acquire than nuclear or chemical weapons and could be used to secretly infect American communities. While some disease agents are available in nature, the great majority would be difficult to produce in volume or to develop for use in effective mass weapons. Smallpox, considered a major threat, is almost completely inaccessible. Eradicated from the world by 1980, the only remaining strains are kept under high security by the United States and by Russia. It was earlier intended that all surviving smallpox would be destroyed in 2001. That decision was delayed when the World Health Organization became persuaded that more defensive research should be done on smallpox (5).
Even before 9/11, many in the US government presumed that terrorists (like those in al Qaeda cells or members of the Aum Shinrikyo cult in the 1990s) would seek large-scale destruction of their enemies. However, it should be noted that the basic technology for creating and using biological weapons has been available for at least fifty years without any such large, fatal attacks anywhere, by states or by terrorists. The question remains whether the United States has embarked on a “looking-glass” war in which it has imagined a threat of biological weapons for which there is little or no evidence. Instead, the US has presumed that terrorists have or will use new biotechnologies and therefore American scientists must forge ahead to develop those new germ weapons in order to prepare defenses against them.
At the least, the availability of technological defenses against biological agents decreases the incentives for terrorists to use them. With anthrax, for example, it is known that antibiotics have life-saving properties if administered soon after exposure. Since anthrax is not contagious from person to person, an outbreak can be effectively contained by the distribution of drugs from the federal antibiotic stockpile. This distribution took place in the aftermath of the anthrax postal attacks and likely saved lives.
As another example, the smallpox vaccine is effective if inoculations against the virus take place early in the course of the disease. It has also been possible to engage the public in stopping any such outbreak from spreading. This kind of response took place successfully in New York City in 1947. In Yugoslavia in 1972, the government was able to contain a smallpox outbreak by quarantines and the vaccination of nearly 20 million people, in both urban and rural areas (6).
Side effects associated with both the current anthrax and smallpox vaccines have led to projects to improve both and to find other, less risky ways to protect both civilian and soldier from potential attack. Projects are also underway to prevent infection from the Ebola virus (which is dangerous but not highly contagious), as well as other diseases known to have been researched in state biowarfare programs.
New drugs could also make other select agents relatively ineffective. Since there are more than 40 such agents that affect humans and many more that can infect animals and plants, biodefense research could be long-term and extensive.
Critics have pointed out that too much federal money is being invested in research to combat diseases that pose little or no public health threat, in comparison to the little support given to international epidemics of AIDS, malaria, cholera, sleeping sickness and other preventable diseases that kill millions each year. Public health advocates have also noted that their work depends on the public’s trust in them, which could be undermined by secret projects and agendas (7).
In contrast, scientists who are committed to biodefense research argue that federal funding can lead to basic breakthroughs in medical science, for instance, drugs that are effective against viruses or that enhance the immune system. The head of the National Institutes of Allergy and Infectious Diseases (NIAID), Anthony Fauci is a strong proponent of dual use benefits (8). As an example, NIAID has recently developed a new vaccine against the Ebola virus that works well in monkeys and in the spring of 2004 was being tested on volunteers who would not be exposed to Ebola but rather monitored for the vaccine’s effect on their immune systems. Ebola outbreaks, while highly fatal, have been small. In 2003, the WHO announced the last one, which affected 11 people.
The dual-use argument allows its advocates to leave unquestioned the government’s representation of the threat of bioterrorism. Those advocating dual use also tend to say they believe in better public health. Usually they mean new medical technologies and centralized hospital care, rather than the community clinics and prevention programs (e.g., childhood immunization, HIV prevention, prenatal care, influenza shots for the elderly) with which public health physicians are preoccupied.
All technological innovations come with some increase in risk. The risks that critics have associated with more Level 4 facilities include those in which:
In the first category are laboratory accidents through which the local community might be infected. Despite safety precautions, dangerous pathogens have been known to escape from high containment laboratories. Even recently laboratory workers have been infected in the course of their work on select agents (9). There also exists the possibility of the theft of select agents or of sabotage, as in the targeting of a facility by terrorists. The transport of select agents could also pose a similar set of risks.
In the second category, which involves scientific skills, the increased numbers of scientists and technicians familiar with creating and testing select agents might pose a risk. The federal government requires the heads of laboratories involved in select agent research to register all those who have access. Yet the increase in the numbers of labs and workers, combined with worker mobility over time, could increase risks beyond government control. Increased research on select agents and biological weapons by intelligence agencies (by the Defense Intelligence Agency, the Central Intelligence Agency, the Department of Homeland Security, and various private contractors) might also increase this risk from defensive initiatives. The FBI suspects that the perpetrator of the anthrax postal attacks was, in fact, an American scientist, not a Middle Eastern terrorist.
Most scientists who study disease have pursued their work without the imposition of government secrecy or restraints on publication. The presumption has been that advances in biology and medicine are for the general good of humanity. In the US context, the presumption has also been that scholarly openness increases research competition and quality. At the same time, pharmaceutical companies have benefited from the discoveries made by federally-funded researchers at universities, medical schools, and research institutes.
One of the problems that biodefense initiatives pose is the greater constraints being imposed on research and publication, as well as limiting the involvement of foreign nationals as researchers or technicians (10). Those scientists involved in biodefense have to consider whether their work will be classified or labeled “sensitive” and allowed only limited distribution and recognition in science. In 2003, the editors of major scientific journals decided that they would consider censoring articles conveying information that might be of specific interest to bioterrorists.
Secrecy in the case of security breakdown causes special concern among those who have studied large-scale disease outbreaks. The tendency of state governments to deny dangerous epidemics has in the past made those epidemics worse in terms of public health and also eroded public trust (11). Iraq’s denial of a smallpox epidemic in 1971 led to a traveler’s spreading it to Yugoslavia in 1972. In 1994, fearing trade would stop, India denied outbreaks of plague and caused great public panic and disruption. China denied the onset of the SARS epidemic in 2003, which only led to its international spread and unnecessary illness and death. It stopped travel and had economic consequences throughout the east and in cities as far away as Toronto. The Soviet military and intelligence kept silent when the 1979 anthrax outbreak began in Sverdlovsk. Their secrecy and disinformation about the cause of the outbreak (that it was from infected meat) delayed diagnosis and made it impossible to treat many of those who died.
While it is understood that biodefense projects are in the interests of the nation, critics note that “environmental” risks associated with new technologies tend to fall heaviest on disadvantaged populations. New Level 4 laboratories have been fought by middle-class communities that learned about them in advance, for example, in Davis, California. This is the “not in my backyard” reaction that poorer communities rarely mount. Opponents to the proposed Boston University facility have pointed out that its location is in a relatively depressed neighborhood in the inner city and also just north of a large urban ghetto of Hispanics and African-Americans.
At the same time, the proposed Boston University facility is near highly affluent city neighborhoods to the north (Beacon Hill and Boston Harbor) and west (Brookline). The site is also close to the city’s downtown area, with its many office buildings and seasonal tourist attractions. Inequity in risks is still likely. In the event of a city-wide emergency, it is predictable that the risks of harm would be felt more by disadvantaged populations concentrated near the facility and to the southeast and less by affluent urban residents, white-collar workers who commute from the suburbs, or tourists, who also tend to white and middle-class. General differences in health status and in education, literacy, and access to medical care could also influence post-exposure risks.
Although new efforts are underway to improve the early reporting of unusual symptoms and diseases (12), disadvantaged populations might be at risk for slow or incomplete reporting. In the event of a contagious disease outbreak, such an inequity could pose a secondary risk for other, more advantaged populations.
Three main issues have been raised concerning the BSL4 high containment laboratories. These are economic benefits and risks, the problem of secrecy and public participation, and physical risks from the disease agents.
The building of a Level 4 laboratory offers the short-term economic benefit of new construction and the jobs it generates. It offers the longer-term benefit of a research center, with jobs for some dozens of scientists, technicians, and service and janitorial personnel. The numbers of those employed would be limited by the size of the facility and the availability of funding. No guarantees for future funding can be presumed, especially as more numerous Level 4 laboratories compete with each other for projects.
A Level 4 laboratory might be converted to Level 3 for work on less dangerous agents with greater dual-use potential. This conversion could reduce the risks and costs associated with it and perhaps increase the range of funding opportunities. Still, many Level 3 laboratories already exist, especially in major medical centers with established records of successful funding.
The work done in Level 4 laboratories may be too associated with dangerous diseases to be tolerated in an urban area. Any accident, terrorist event, or hoax that attracted public attention could have serious negative effects on real estate, office space, and tourism. The continued association of the SARS epidemic with the city of Toronto might illustrate the financial downside of a BSL4 in a congested locale.
Whether the proposal was for a new BSL4 facility in California, New Mexico, or Massachusetts, communities and activist groups have been concerned about government secrecy and have argued for public participation in decision making.
Biodefense research is a national security endeavor that, unlike research on nuclear weapons, involves medical matters about which the public is used to being advised. Information about the annual threat of influenza or new outbreaks of West Nile Virus or SARS (Severe Acute Respiratory Syndrome) is broadcast as an important government service by the Centers for Disease Control. Why should information about potential “deliberate outbreaks” be kept from the public, which needs information in order to protect itself in an emergency?
Concern about secrecy extends to the question of whether any external review commission would oversee the kinds of research projects that would be conducted in the facilities. Will there be effective Congressional committee oversight of BSL4 and other biodefense research? Will there be effective scientific review of such projects? Will ordinary citizens have the right to know about this research, through the Freedom of Information Act, for example, or through their elected representatives? Finally, will members of the local community be informed about the BSL4 research and allowed to influence it to reduce risks, for example, in not allowing aerosol experiments with lethal agents?
Another concern is whether scientists can maintain control over their research projects. Suppose a senior research scientist does not want her or his work classified, although the government does? Will medical centers that sponsor BSL4 laboratories and their scientists opt for more secrecy or more dangerous select agent research in order to qualify for funding?
The physical harm, including illness, disease and stress, that might be caused by a BSL4 laboratory is the central issue of debate.
There are two ways of thinking about the likelihood of physical harm related to BSL4 facilities. One is the way in which the security measures intended to reduce risk could fail. In March 1966, when the US was still making chemical weapons, one of its test planes accidentally released nerve gas on sheep in rural Utah, in a place called Skull Valley (13). At first, to protect its program, the Army denied that it had been testing nerve gas. Soon, through a leak from a Congressional office, it became known that the military was responsible. A year later, Congressional hearings further raised public alarm about the Army’s ability to maintain safety standards.
The practices of people employed at the BSL4 facilities are supposed to be sufficient to minimize risk. Those who work within the high containment laboratories should follow rules for suits and masks, showers, and prompt reporting of accidents. Vaccinations are available for anthrax and smallpox, but for other dangerous diseases, such as hemorrhagic fevers, workers are at risk of infection. The care of BSL4 test animals is also regulated to reduce risks of contamination. Although unusual, instances of workers becoming infected with select agents have occurred in past state programs and continue to do so (9).
Those employed in laboratories where work on select agents is taking place are expected to protect the national security interests of the US. Their commitment should make it highly unlikely that they would either through carelessness or intentionally allow any unqualified person access to select agents or provide knowledge about their transport, research development or testing, or the characteristics of any agent.
Those who work with select agents are cleared by the Attorney General’s office and the Department of Health and Human Services, using data bases that track for potential terrorists. However, the United States has a history of what are called “lone operators,” like Timothy McVeigh, the ex-Marine who blew up the Murrah Building in Oklahoma City in 1995.
The construction of the laboratory and the larger building are supposed to impose barriers to infection. Should a research project involve the testing of aerosols of select agents, the failure of safety measures could pose a serious hazard to the local community and perhaps the region. In the famous 1979 Sverdlovsk outbreak, in which around 70 people were killed by an anthrax aerosol, it is likely that a mistake was made regarding the filtration system at the nearby military facility where anthrax was being produced and tested.
The security guards and surveillance that the sponsoring institution provides is also intended to reduce the risk of physical harm. Who can enter and leave the building that houses a Level 4 lab and who can gain access to the lab itself is important. If select agents and the technology for their dissemination are of interest to terrorists, the centers where they are to be found need high levels of surveillance. The transport of select agents between laboratories also requires security.
A second way to think about BSL4 facility risks is its location and how it might be affected by a security failure. What if the plane spraying nerve gas in 1966 had been near an area populated by people instead of sheep? In Sverdlovsk in 1979, the Soviet military was producing and testing deadly anthrax spores at a facility in the city. If the amount of anthrax released in 1979 had been greater, many more than 70 people would have died.
The risk of an exotic, lethal disease spreading to a local community has been a major concern. The placement of a Level 4 facility in a remote area partially addresses this concern by reducing the number of people outside the facility who might be in harm’s way. Conversely, the placement of a high containment facility in a heavily-populated area increases the numbers of people potentially exposed to disease or, in some scenarios, to terrorists targeting the laboratory.
The placement of a facility in an urban area also introduces the problem of how a population should or could disperse, in the event of an outbreak. If a disaster requires evacuation, traffic congestion could become a problem. According to some scenarios, a large diverse urban population might flee in panic in the event of an intentional outbreak. If the disease were highly contagious, this flight could increase risks that new populations would be infected. The fear factor in sudden serious epidemics could cause panic—or not. Much would depend on the public’s confidence in government information on what it should do in an emergency and on the specific circumstances of an outbreak.
Most diseases caused by select agents cannot be protected against in advance.
Either no vaccines or immunization is available or what is available poses
risks of side effects. Anthrax and smallpox vaccines have both generated
serious side effects in military personnel and in some civilians.
In addition, epidemic diseases are most threatening to populations that
have health problems or are physically susceptible to infection for other
reasons. For this reason, diseases are sometimes referred to as “opportunistic.”
In the event of an aerosol release or person-to-person contagion, the
presumption is often made that the community nearest the Level 4 facility
is most at risk. Therefore, the demographic characteristics of such a
community are important. Low levels of income are often associated with
high levels of illness or generally poor health. Minority status is also
associated with health problems at levels higher than found among non-minorities.
Age can mean vulnerability. It is possible that older people are especially
susceptible to inhalational anthrax, for example. Children, pregnant women,
those who are HIV-infected, and those already ill may be among those particularly
vulnerable to some of the diseases caused by select agents.
In the event of an emergency, a local community may also be vulnerable due to a low level of literacy or fluency in English. The media would likely be an important source of information in an emergency, as they were in the 1942 smallpox outbreak in New York. But language barriers could reduce important communication. The rapid distribution of medicines, hospital triage, vaccination programs or the evacuation of an area requires an informed, aware public. It is important, therefore, to consider the general education of the local population as an indication of vulnerability.
A large hospital located near a Level 4 facility would represent another population at physical risk. Those who are hospitalized and those who regularly seek out-patient care might be especially vulnerable to a sudden, unusual epidemic.
In addition, factories or office buildings where large numbers work or people caught in congested traffic might also be vulnerable to accidental exposure.
The most dangerous scenario associated with a Level 4 laboratory is the emission of a lethal aerosol, as happened in Sverdlovsk, USSR, in 1979. That aerosol had a lethal effect on livestock at a distance of around 30 miles from its source at a military facility. A similar aerosol release from a Level 4 facility in the US would make the risk of an accident regional as well as local.
The risk of a Level 4 facility would also extend beyond the immediate locale (whether urban or not) if a breakdown in standards or security led to the spread of a contagious disease. A laboratory worker could spread disease in a suburban community as well as an urban one. Travel is another way in which contagious diseases traditionally spread. The ease and frequency of international travel has increased this risk.
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