Ronald M. Atlas is President-Elect of ASM and a Professor of Biology at the University of Louisville, Louisville, Ky. This article is adapted from a presentation at the ASM Special Symposium on Bioterrorism Preparedness at the 41st ICAAC in Chicago, Ill., on 16 December 2001.
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Bioterrorism: the ASM Response
ASM supports expanding restrictions on select agents, while ASM journal editors are mindful of special stewardship role
Ronald M. Atlas
Never before has the biomedical community faced a greater challenge—protecting the public against infectious agents while facing heightened scrutiny over the misuse of science by terrorists. Since the anthrax attacks last year, ASM and its members have been responding tirelessly to a wide variety of questions surrounding bioterrorism. During this period, the ASM website has been posting critical information for microbiologists, physicians, and the public. The website provides a wide variety of useful articles, reports, texts of legislation and regulations on bioterrorism and select agents, and also links to important related sites.
Access to Biological Agents
In the aftermath of the 11 September terrorist attacks and the anthrax incidents, ASM quickly became the organization which the Congress and policy and opinion makers turned to for expert advice and information on issues related to pathogenic microorganisms, biological weapons control, and laboratory security. ASM established electronically available information on biological weapons issues on a new resource page on the ASM website to provide essential and timely information for ASM members, congressional and agency staff and officials, and the media. The ASM Public and Scientific Affairs Board (PSAB) responded to many calls for information, interviews, and advice from Congress and the media, and ASM officers appeared on television, participated in radio talk shows, and were quoted in news articles in major newspapers and in science articles. ASM was consulted by congressional committees in both the House and Senate on epic antiterrorism legislation affecting microbiology.
In September, the Bush administration proposed broad antiterrorism legislation that contained provisions establishing additional controls over biological agents. The proposal was to criminalize the possession of biological agents that had no legitimate purpose, ban the possession of certain biological agents by a set of restricted persons, and require the Secretary of Health and Human Services to establish additional standards and procedures governing the possession, use, and transfer of select agents. The proposed legislation took on increased urgency after the death of a Florida man from inhalational anthrax and the subsequent attacks on the media and Congress with anthrax through the U.S. mail. ASM provided expert advice on drafts of legislation to the Senate and House Judiciary committees, the House Energy and Commerce Committee, and the Senate Committee on Health, Education, Labor and Pensions. ASM's goal in doing so was, and is, to maintain an appropriate balance among public safety issues, the concerns of law enforcement, and the protection of legitimate scientific research and diagnostic testing. Although the urgency with which the legislation was handled did not lend itself to the kind of deliberation and consideration ASM would have preferred, the ASM response to the proposals and recommendations and its dialogue with Congress were instrumental in modifying the final language passed in the Patriot Act signed into law on 26 October 2001.
The Patriot Act expands the biological weapons statute, adding an unlawful possession provision in l75b of Title 18 of the criminal code which includes an exemption for research and naturally occurring biological agents. The restricted persons list is narrowed from earlier proposals, particularly from the proposal to exclude all aliens from work with select agents. ASM's concerns with problematic provisions as they might affect legitimate scientific research were documented by Senator Patrick Leahy (D-Vt.).
The Patriot Act does not include a proposed requirement to register laboratories for possession, however, and ASM continues to address this issue with Congress in the context of the bioterrorism preparedness and response authorizing legislation, S. 1715 (later reintroduced as S. 1765) and H.R. 3448. ASM was asked to testify on 6 November before the Senate Judiciary Subcommittee on Technology, Terrorism and Government Information, chaired by Senator Diane Feinstein (D-Calif.), and filed an extensive statement on policy and ASM's views with respect to expanding controls over dangerous biological agents and existing regulations and proposed legislative proposals. I testified before the Subcommittee, engaging in dialogue on the issues with Congress. ASM input was reflected in important modifications to the bill Senator Feinstein introduced on 8 November, S. 1661, which includes exemptions for clinical diagnostic testing. ASM provided extensive consultation on provisions in the House and Senate legislation, S. 1765 and H.R. 3448, which passed in the House on 12 December and the Senate on 20 December (see box, p. 119). Following passage of the final bioterrorism prevention legislation in early 2002, ASM will be involved in the development of regulatory policy with regard to laboratory and research personnel security.
Access to Research Findings
Beyond the laws and regulations that limit access to select agents lies the possibility of restricting access to specific information that might be useful to bioterrorists. Should more microbiological research be classified? What would warrant restricting publication or other means for disseminating research results? Should we stop revealing genome sequences? Should particular research findings or methods be withheld from publication? Should there be review boards to consider the national security implications of all scientific publications that might bear on bioterrorism or other forms of terrorism?
ASM values openness in science and favors sharing the benefits that accrue from microbiological and related research efforts. Thus, if someone wants to publish legitimate research findings that can advance biomedicine more generally, ASM should not act as a censor. However, this position favoring openness of science is not universally shared. For example, bioethicist Arthur Caplan from the University of Pennsylvania is widely quoted as saying, "We have to get away from the ethos that knowledge is good, knowledge should be publicly available, that information will liberate us. . .. Information will kill us in the techno-terrorist age, and I think it's nuts to put that stuff on Web sites."
Several years ago, ASM concluded that information describing the genome of the smallpox virus should not be classified but should be published in the open scientific literature because those sequence data would be especially valuable for understanding the virulence of this virus and providing targets for designing therapeutic drugs. Indeed, analysis of the smallpox viral genome subsequently revealed the basis for its virulence, including its capacity to modulate host immune responses, as well as potential targets for vaccines, drugs, and novel detection procedures, information that seems of far more value to legitimate researchers than to bioterrorists (see Current Topics, p. 109).
The same sort of questions have been raised about publishing the genomic sequence of Bacillus anthracis and other comparable scientific findings. So far, despite expressions of concern, the decision has been to continue to release genomic data. With genomic data viewed as valuable for identifying targets for therapeutic drugs and vaccines, such information also can be viewed as potentially valuable for identifying means to increase the virulence of such agents and to counter currently available therapies, vaccines, and detection protocols. This duality is very real, and the potential for both good and evil surely is encoded within these genomes.
This heightened concern about publishing research results and the conviction in some quarters that some lines of experimentation should be banned emanates, in part, from an earlier response to experiments conducted in Australia in which the interleukin-4 (IL-4) gene from a mouse were inserted into the mousepox virus, enhancing its virulence (J. Virology 75:1205-1210; also see ASM News, April 2001, p. 182). When that modified virus expresses the IL-4 gene, it effectively overcomes genetic resistance to mousepox virus and suppresses immune responses of the host to a much greater extent than anyone had predicted. Virus-encoded IL-4 not only suppresses primary antiviral cell-mediated immune responses but also can inhibit immune memory responses.
Such experiments indicate that poxviruses can be engineered by widely available techniques and equipped with readily accessible genes to render immunization ineffective. The implications for the smallpox virus, were it to be genetically engineered in much the same way, are horrific. With hindsight, some critics have asked whether this research should ever have been permitted. They also suggest that we should have known in advance how dangerous these results proved to be. Others, some of whom were surprised by the results, say that this study alerts us to the need for more research on immune responses to such viruses and the need to develop antiviral drugs.
ASM Editors To Intensify Review of Selected Research Reports
In light of these concerns, the editors of the 11 ASM journals recently met to consider what ethical and national security criteria any of them would invoke to reject publishing a research report. They agreed that none of them would want to publish papers that violated the ASM Code of Ethics or that violated other widely accepted guidelines for research, such as the National Institutes of Health (NIH) guidelines pertaining to research involving recombinant organisms. The editors also were very sensitive to research reports that might impinge on national security issues. However, they are not prepared to restrict the flow of legitimate scientific communications within microbiology and that could lead to valuable advances in biomedical science.
After carefully deliberating over these issues, the ASM journal editors drafted the following consensus statement: "The ASM recognizes that there are valid concerns regarding the publication of information in scientific journals that could be put to inappropriate use. The ASM hopes to participate in the public debate on these issues. Until a national consensus is reached, the rare manuscript that might raise such issues will be reviewed by the ASM Publications Board prior to the Society proceeding to publication."
This statement with an accompanying introduction subsequently was shared with the members of the editorial boards of all of the ASM journals to alert them to their responsibilities in these matters. Through this and other continuing review efforts, the editors of the ASM journals will continue to be responsible stewards of scientific information while carefully balancing recently heightened national security needs with the value of advancing science for the benefit of humanity.
Current ASM President Abigail Salyers of the University of Illinois, Urbana-Champaign, recently commented on these matters. "Terrorism feeds on fear, and fear feeds on ignorance," she says. "The best defense against anthrax or any other infectious disease is information—information in a form that can be used by scientists and by members of the public to guide rational and effective actions to ensure public safety. Placing major new barriers in the path of the flow of information. . .may ultimately contribute to terrorism by interfering with our ability to prepare and to respond to the threat of the misuse of science by bioterrorists."
Proper Conduct in Research
Beyond the obvious need to further biomedical research and to strengthen the public health infrastructure, one can ask about the appropriate role of the scientific community in identifying misconduct, including the grave misconduct associated with bioterrorism. What obligation do members of the research community have to identify, call attention to, or clarify activities of others that may appear suspicious? Are there areas of research or types of experiments that pose such a threat regarding their potential application to the development of bioweapons that they should be conducted under extraordinary conditions of transparency and openness—or not conducted at all? And are there bioethical considerations that require scientists to be whistle blowers when the public health is threatened?
After 11 September 2001, the ASM Council Policy Committee affirmed a longstanding position of the Society, declaring that microbiologists will work for the proper and beneficent application of science and will call to the attention of the public and appropriate authorities misuses of microbiology or of information derived from microbiology. ASM members are obligated to discourage any use of microbiology contrary to the welfare of humankind, including the use of microbes as biological weapons. Bioterrorism violates the fundamental principles expressed in the ASM Code of Ethics and is abhorrent to ASM and its members.
Unfortunately, there have been times when some microbiologists and also physicians have not adhered to this ethical standard. Key leaders of the Aum Shinrikyo were scientists and physicians, as were those who directed the biological weapons programs of Iraq and the former Soviet Union. For example, consider the following statement of Ken Alibek, former first deputy chief of the Biopreparat , the organization overseeing the Soviet biological weapons program. "Before I became an expert in biological warfare I was trained as a physician," he said. "The government I served perceived no contradiction between the oath every doctor takes to preserve life and our preparations for mass murder. For a long time neither did I."
Such violations of the fundamental ethical principles of physicians and microbiologists must not be tolerated. We as scientists and physicians must seek to deter and defend against bioterrorism and to help detect and mitigate bioterrorist attacks. We must continue to combat infectious diseases through conducting high-quality biomedical research, medicine, and clinical microbiology, and by renewing our dedication to efforts that will reduce the threat of infectious diseases throughout the world.
Infectious diseases and bioterrorism represent major threats to national and global security. By enhancing global epidemiological surveillance systems, by developing advanced diagnostics, and by discovering new and better vaccines and antimicrobial agents, we will develop the tools needed to combat both natural outbreaks of infectious disease and intentional acts of bioterrorism. To achieve these ends, we will need to increase our investment in research efforts aimed at eliminating the threats of bioterrorism and of natural epidemics that can strike anywhere in the world. The scientific community must move forward as quickly as possible to reduce the threat of bioterrorism by developing effective preventive measures and cures for infectious diseases that now represent a credible threat to humanity. It is imperative that we win the war against bioterrorism without allowing biomedical science to fall victim in the enduring battle against disease.
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