|
|
|
 |
Research on Biodefense Can Get Generous Funds, but With Strings Attached By JONATHAN B. TUCKER From the issue dated March 5, 2004 Section: The Chronicle Review Volume 50, Issue 26, Page B10 Biodefense research is a double-edged sword for universities. It can bring in important new sources of support, but with major strings attached. In the aftermath of September 11, 2001, and the subsequent anthrax letter attacks, the Bush administration began investing large amounts of money in defenses against weaponizable pathogens such as the causative agents of anthrax, plague, tularemia, botulism, and Ebola hemorrhagic fever. Federal outlays for research and development on biodefense jumped sixfold in one year, from $291-million in 2002 to $1.75-billion in 2003, and similarly large appropriations were made in 2004 and have been proposed in the administration's budget request for 2005. In September 2003, the Department of Health and Human Services announced grants totaling $350-million to establish eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research, seven of them at research universities. The Bush administration's largess also extends to the construction of new biocontainment laboratories equipped with filters, barriers, and air-handling systems so that researchers can handle deadly and incurable pathogens while minimizing the risk of accidental infections of lab workers or releases from the facilities that could endanger public health or the environment. The National Institute of Allergy and Infectious Diseases is providing one-time grants of $120-million each for National Biocontainment Laboratories at Boston University and the University of Texas Medical Branch, in Galveston, and grants of between $7-million and $21-million to build Regional Biocontainment Laboratories at nine other universities. The two national labs will be at the maximum level of containment, Biosafety Level 4, which is required for work with the most deadly and incurable viruses; the regional labs will be at the next-highest level, Biosafety Level 3, which is required for work on aerosolized anthrax spores and certain other bioterrorist-threat agents. The 2005 fiscal-year budget calls for two additional BSL-4 centers and 20 more BSL-3 labs. All of that investment has created major financing opportunities for the chosen institutions, but it entails risks as well as benefits for both academe and the public. First, it is unclear that the current level of biodefense support will be sustained over the long term. Second, by greatly expanding the number of people working with dangerous disease agents, the boom in biodefense research could potentially increase the danger of theft or diversion of pathogens for malicious purposes -- unless measures to improve laboratory security are strengthened significantly. Most agents that could be used for bioterrorism are available from natural sources, but because such isolates often have a low virulence (ability to cause disease), a terrorist would have to isolate many different strains before finding one that was sufficiently potent to serve as a weapon. Given those technical hurdles, it would be far easier for terrorists to steal or divert well-characterized strains from a research laboratory. In response to worries over biosecurity, two laws passed in the wake of September 11 significantly tightened controls on access to agents of bioterrorism concern. The 2001 Patriot Act makes it a crime to knowingly possess any biological pathogen, toxin, or delivery system that cannot be "reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose." The law also excludes from access to dangerous pathogens several categories of people, including nonresident aliens from countries on the State Department's list of nations that support terrorism. That exclusion is applied without exception or right of appeal. The second law passed in the wake of the anthrax attacks, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, mandates the regulation of all American domestic facilities that possess, work with, or transfer one or more "select agents" on a list of 82 human, animal, and plant pathogens and toxins. Such facilities must register with the Centers for Disease Control for human pathogens, or the Department of Agriculture's Animal and Plant Health Inspection Service for plant and animal pathogens. The registered institutions must implement measures to prevent terrorists from gaining access to the select agents in their possession, such as conducting risk assessments and improving physical security and pathogen accounting procedures. In addition, the roughly 9,000 American scientists seeking to work with listed agents must undergo an FBI security-risk-assessment screening against criminal, immigration, terrorism, and other national-security databases. The requirements for background checks and laboratory inspections have slowed the certification of labs seeking to work with select agents. Because of delays in sending out and processing the application forms, many risk assessments were not completed by the initial deadline of November 12, 2003, forcing the FBI to grant an extension. Poor coordination between the CDC and APHIS over so-called overlap agents, which affect both human and animal health, has also complicated the lab-certification process. The regulations state that overlap agents can be reported to either agency, but in practice the CDC and APHIS have not integrated their procedures. Although tightened laboratory security is clearly warranted in the post-September 11 environment, the select-agent rules must not become so onerous that they impede good science. As a result of the new regulations, university researchers working with select agents have had to spend many hours filling out extensive paperwork and negotiating a series of confusing bureaucratic hurdles. Some academic institutions have required laboratories working with select agents to hire a full-time biosecurity officer to ensure compliance with the complex rules. Moreover, research on mad cow disease, which was recently detected in the United States for the first time, has been slowed because the causative agent (the BSE prion) is covered by the new biosecurity regulations. As a result, all American labs that work on BSE prions must undergo inspections and background checks, although similar research in Europe is unregulated. Given the threat that mad cow disease poses to the American livestock industry, some restrictions are warranted to ensure that only bona fide scientists have access to the causative agent. But because it has a seven-to-eight-year incubation period in humans, it is an unlikely bioterrorist weapon and should not be regulated as stringently as high-threat agents such as anthrax bacteria. Even if researchers maintain careful records, it is always possible that a few vials containing pathogens could be misplaced or inventoried incorrectly. Yet the legal consequences of such minor oversights can be severe. In July 2002, a student at the University of Connecticut, Tomas Foral, was arrested and charged under amendments in the Patriot Act to Title 18 of the U.S. Code for retaining two vials of anthrax-infected tissue in a laboratory freezer after he had been told to destroy them; Foral avoided indictment in exchange for community service. In another case, Thomas C. Butler, a scientist at Texas Tech University, was arrested in January 2003 for allegedly lying to FBI agents about the disappearance of 30 vials of plague bacteria, which he had brought to the United States from Tanzania. On December 1, 2003, Butler was acquitted of smuggling plague samples and lying to the FBI, but was convicted of 47 counts of fraud and improperly shipping samples. He plans to appeal. The potential for legal liability from minor oversights in select-agent accounting may deter other scientists from conducting vitally needed research on dangerous pathogens. The new biosecurity rules may have already had a chilling effect at research universities. At Duke University, for example, 57 laboratories were working with select agents before the new regulations went into effect. Within a few months, six of the labs discontinued such work, one destroyed its stocks, and two transferred them. Even more worrisome, the regulations have led some academic laboratories to destroy rare archival stocks of human, plant, or animal pathogens. Iowa State University discarded its entire collection of anthrax specimens after the Ames strain was linked to the 2001 anthrax letter attacks, and scientists at several other institutions, including the University of Pennsylvania, Duke, and Harvard University, have also destroyed stocks of select agents that were not in active use. To prevent scientists from eliminating additional specimens that could be valuable for forensic analysis and future research, the federal government has established a temporary repository to store unwanted cultures of select agents. Although the U.S. select-agent rules are seriously flawed and need to be revised, at least the United States is trying to do something about the problem. Many other countries have yet to introduce biosecurity regulations, making it possible for terrorists to obtain samples of bioterrorist- threat agents from foreign sources. Worldwide, thousands of research laboratories and culture collections store dangerous pathogens under insecure conditions. In the Soviet successor states, for example, former biowarfare and "anti-plague" research institutes possess collections of virulent strains that could be stolen or diverted by terrorists or criminals. To be effective at preventing bioterrorism, biosecurity regulations must be reasonably consistent from country to country. At present, however, uncoordinated national rules have created a legal patchwork, containing gaps that terrorists could exploit as targets of opportunity. Although a few international entities such as the European Union and the Organization for Economic Cooperation and Development have begun to develop common rules for laboratory security, those efforts remain embryonic. Only truly global biosecurity standards would significantly reduce the risk that terrorists could obtain dangerous pathogens from sources outside the United States. A set of common standards could be negotiated by a technical working group under United Nations auspices, and then adopted by member governments. Those guidelines would cover laboratory security and access control; mechanisms to track the storage, use, transfer, and export of dangerous pathogens; and procedures for vetting scientists who work with those materials. To date, the Bush administration has opposed any multilateral effort to develop a harmonized approach to biosecurity on the grounds that it could result in watered-down, least-common-denominator procedures. That concern could be addressed, however, by offering technical and financial assistance to developing countries so that they can implement more stringent biosecurity standards. In sum, university researchers attracted by the influx of federal biodefense dollars should be aware that such support comes with major hurdles and complications. For its part, the federal government needs to rethink some of its policies. To gain the full support of the American scientific community in reducing the nation's vulnerability to bioterrorism, the CDC and APHIS should harmonize their regulatory procedures and streamline some of the more onerous aspects of the select-agent rules. The Department of Justice should rethink its harsh enforcement of the new regulations, including the criminal prosecution of scientists for minor infractions. And the Bush administration should reconsider the negotiation of a set of uniform "best practices" for biosecurity that can be implemented internationally. Jonathan B. Tucker is a senior researcher specializing in biological and chemical weapons at the Center for Nonproliferation Studies of the Monterey Institute of International Studies. His most recent book is Scourge: The Once and Future Threat of Smallpox (Grove Press, 2002).
|
