Scientists Brave New Bioterrorism World

A proposal for a self-policing system to prevent terrorists from learning cutting-edge biotech information puts US life scientists face-to-face with the prospect that the broad freedoms they've traditionally enjoyed could be constricted. A National Research Council (NRC) committee formally suggested in October that scientists create a voluntary system to review all future American biotechnology experiments.1 Under the proposal, research judged too sensitive would be voluntarily moved into high-security labs. The committee acted, some members say, to prevent the federal government from enacting a stricter security system that could impose even tighter restrictions on researchers' freedoms. The Bush administration may still mandate a more restrictive system. But it's still an open question, says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, "[It is] being discussed at multiple levels of government, including the Homeland Security Council at the White House." Many concede that honest scientists might inadvertently create and then publicize directions to build a potentially catastrophic bioweapon. In 2001 Australian scientists trying to make a rodent contraceptive inserted an interleukin gene into mousepox virus. Using what the committee report calls "standard and quite simple procedures," they inadvertently created a superpathogen that killed not only 60% of resistant-strain mice but also decimated vaccinated mice. That work was published, and bioterrorists are now free to read it. The mousepox snafu is exactly the kind of problem scientists want to address on their own, before the government does it for them. "This may be one of the most difficult dilemmas in science policy that we have ever faced," says D.A. Henderson, formerly President Bush's chief advisor on how to respond to bioterrorist strikes once they occur. THE PROPOSAL The proposed bioresearch security program would apply to all US scientists, not just to publicly funded ones, and cooperation with the program would be voluntary, according to the committee's report, released October 8. Scientists who choose not to cooperate would not be punished. Under the proposal, if an organization's biosafety committee could not decide whether to allow an experiment to proceed in a nonsecure lab, it could contact the Recombinant Advisory Committee (RAC) of the National Institutes of Health, which would expand from its current purview of overseeing genetic research funded by NIH to cover all American research, regardless of funding sources. A new National Science Advisory Board for Biodefense would be the final arbiter, if needed. The committee also proposes a continuing dialogue between editors and national security experts to decide what results might be too dangerous to publish. In February, a group of journal editors proposed just such a self-review to keep potentially harmful information out of terrorists' hands. Richard Ebright, a bioterrorism research expert and professor at the Waksman Institute of Microbiology at Rutgers University, NJ, calls the committee's proposed program "naïve," and predicts it would result in "minimal participation from laboratories in the industrial, government, and defense sectors." Scientists wouldn't even need to refuse to cooperate, he says. They could simply not opt into the system. Stanley Falkow, professor of medicine, microbiology, and immunology at Stanford University, supports the committee's proposal, because it preserves open communication among scientists. "There's an awful lot of people who believe that the best biodefense is actually openness in science," he says, "in which one stays really at the cutting edge of what's going on and you're always ahead, as it were, of the bad guys who want to do mischief." Critics of government-scientist relations point to the arrest of Thomas Butler, chief of the infectious disease division at Texas Tech University's Department of Internal Medicine, who was hit with multiple federal charges after he confessed, under pressure, that he had destroyed plague vials the FBI claims he smuggled from Tanzania. The critics say that scientists angry over that case may refuse to cooperate with the government. Fauci acknowledges that the government needs to educate scientists better about federal rules for importing and handling dangerous diseases. He predicts that "a well-informed scientific community will be less reticent to get involved if they know exactly what the landscape is that they're getting involved in." BIOLOGY AS PHYSICS Some critics contend that biologists need to wake up to the necessity of the military-style security classification system, which physicists have worked under since they built the atomic bomb 60 years ago. "Defense-relevant biomedical research, especially defense-justified and defense-funded biomedical research, should be subject to the same scrutiny as defense-relevant physics research," Ebright says. Ebright asserts that such secrecy would not hold back biotech progress. Judging from the relative sizes of various NIH budget components, he roughly calculates that secrecy rules would apply to much less than 10% of biomedical experiments in general and to much less than 1% of those using "select" (potential bioterrorism) agents as defined by the Centers for Disease Control and Prevention. John Marburger, the president's science advisor and an applied physicist who previously directed the Brookhaven National Laboratory in New York, rejects the biology-as-physics idea. "Everything you learn about infectious disease to help prevent it and provide therapies for it can have another side of the coin, which is enhancement of the pathological aspects of an organism," he says. The committee's report agrees that biological research has this intrinsic dual-use, good-bad nature. "The challenge is for the scientific community to develop a system that permits fundamental research to proceed unimpeded, while identifying research with great potential for misuse." Department of Health and Human Services (HHS) secretary Tommy Thompson must respond by Nov. 5 to seven specific recommendations in the committee's report. According to Fauci, Thompson will decide which recommendations HHS will participate in and whether to propose further restrictions. VOLUNTEERISM VS. BIOTERRORISM Some critics say a voluntary security system is no match for bioterrorism. The committee disagrees, pointing out that the USA Patriot Act, the Bioterrorism Preparedness and Response Act of 2002, and regulations governing experiments using "Category A" (potentially lethal) diseases such as anthrax, smallpox, and plague already address the problem of researchers who want to aid terrorists. The proposed experiment-review system is expected to address the possibility that honest scientists might unknowingly aid terrorists, committee members say. Committee members assert that scientists will more likely cooperate with an expanded-purview RAC than with a new committee, because the existing RAC is arguably the most important example of the American scientific community's unanimity and moral resolve since World War II. In 1975, in the wake of the first successful gene-splicing experiments, which the report calls "then a novel technology of unexplored potential," scientists at the now-famous Asilomar conference agreed to restrict recombinant experimentation to prevent spread of novel organisms. The now-classic 1976 NIH "Guidelines for Research Involving Recombinant DNA Molecules" codified that concern. The guidelines were gradually eased, as years of subsequent research produced no recombinant-related disease. "What the original RAC did was to create [a] very pervasive culture of responsibility among the scientific community," Fauci relates. "Even though there were groups, including industry, who were not bound by NIH funding ... everybody respected the DNA guidelines." FUTURE FEDERAL REGULATIONS Marburger expressed satisfaction with the committee's proposal. "We're not a secure country unless the American people feel that [we're] taking appropriate actions to keep us secure," he says. Marburger also insists the Bush administration has no plans to restrict basic biological research. The government should clarify for scientists what the possible new category of "sensitive but unclassified information means," he says. "I think that as these terms get clarified, the research community will become more comfortable." Nevertheless, Marburger says the report cannot possibly be the last word on the regulation of biotech experiments, simply because this research constantly changes and progresses. Government agencies that fund life- science research, such as the NIH, Department of Defense, Department of Energy, and National Science Foundation, may create their own mandatory system of rules in addition to the committee's voluntary system, Marburger says. Fauci says that the White House and federal agencies are "moving rapidly" to assess the committee's recommendations and decide whether to add any additional mandatory requirements to them. He expects a final decision by early 2004. John Dudley Miller (johmiller@nasw.org) is a freelance writer in Cleveland. 1. Biotechnology Research in an Age of Terrorism: Confronting the "Dual Use" Dilemma, Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, the National Research Council, Washington DC: National Academies Press, Oct. 8, 2003. Correction Professor Richard Ebright of Rutgers University asserts that under a proposal by a National Research Council committee, a requirement for review would not hold back biotech progress. Judging from the relative sizes of various National Institutes of Health budget components, he calculates that less than 10% of all biomedical research involves "experiments of concern" as defined in the National Research Council report (and thus warrants review), and less than 1% of all biomedical research involves the intersection of "experiments of concern" and select agents (and thus warrants close review)." This article, "Scientists Brave New Bioterrorism World," The Scientist, Vol. 17, Issue 21, November 3, 2003, incorrectly stated that Ebright's comments referred to "secrecy" or "secrecy rules," rather than to "review," and misstated Ebright's calculations. function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

Scientists Brave New Bioterrorism World

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