Business Impact

Essay: Biotech's Big Chill

Government efforts to keep science and technology out of terrorist hands conjure images of the Cold War. But it’s biomedical researchers in the United States who could be frozen out.

In late October 2001, Tomas Foral, a 26-year-old master’s student working in a pathology laboratory at the University of Connecticut in Storrs, was asked by a professor to help clean out a failed basement freezer. Foral discovered that the freezer contained several vials of cow tissue infected with anthrax. What happened next is in dispute: university officials would later say the professor told Foral to destroy the vials, while Foral maintains that the professor’s instructions were unclear. In any event, he saved two of the vials for future research by putting them in another laboratory freezer.

A month later, according to media accounts, an anonymous tip led police to Foral and the saved vials. The pathology laboratory building was shut down for more than a week, the FBI began an investigation of Foral, and in July 2002 the government charged him with having violated the antiterrorist USA Patriot Act. Initiated in the wake of the attacks on the World Trade Center and the Pentagon and passed on October 26, 2001, the act contained a section that responded to the anthrax mailings and deaths that had begun early that month. The section prohibited possession of any of more than three dozen lethal biological agents-including anthrax-or genetically modified versions of them, unless it was “reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose.” The penalties threatened alleged violators like Tomas Foral with a hefty fine and up to 10 years in prison.

That section of the USA Patriot Act was just one in a sweeping set of postSeptember 11 provisions designed to control access to almost every aspect of science and technology-not just biology-that could conceivably aid terrorists. In another section, the act tightened regulations on foreign students and provided, among broad controls on all foreigners entering the country, $37 million for a federal electronic database-the Student Exchange Visitor Information System, first authorized in 1996 but then neglected-containing information on foreign students and visitors at U.S. colleges and universities.

This story is part of our July/August 2003 Issue
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A subsequent measure, passed in May 2002, increased the responsibility of educational institutions for recording information about their international students, including whether they were maintaining full academic loads, had changed programs, or had ended their studies. (Rutgers University administrator Marcy P. Cohen lamented to a reporter that she used to spend her time helping foreign students, but that now “I’ve become a data monitor for the government.”) That June, legislation was enacted to protect the public against bioterrorism by denying “restricted persons”-including drug users, dishonorably discharged military personnel, and people suspected of involvement with terrorist organizations-access to dangerous biological agents and toxins. The law also prohibited citizens of countries designated as sponsors of terrorism (currently Cuba, Iran, Iraq, Libya, North Korea, Sudan, and Syria) from accessing certain biological agents.

A deluge of regulations followed the legislation, including draft requirements issued in December 2002 that filled 50 pages of the Federal Register and affected universities, private corporations, and government laboratories handling any of nearly 50 “select” biological agents-for example, Ebola virus, botulism-causing bacteria, and the toxin Ricin. All the laboratories had to agree to unannounced inspections, register their agents with the government, and submit plans for training lab workers and maintaining the security of the agents. Everyone handling the agents would have to undergo a background check and obtain security clearance. The labs would also have to obtain federal approval before conducting genetic engineering experiments that might increase the resistance of an agent or toxin to drugs.

More alarming to biomedical scientists were increasing signs-beginning with an order from the White House chief of staff in March 2002 telling federal officials to keep the lid on unclassified but “sensitive” information related to weapons of mass destruction-that the Bush administration might restrict the as yet untrammeled publication of unclassified research. How aggressively that ominous initiative would be pursued remained to be seen, but the fate of Tomas Foral, a member of the Reserve Officer Training Corps, suggested that the government meant business. Although Foral said he had frozen the anthrax spores for further research, a purpose seemingly allowed by the USA Patriot Act, he escaped prosecution only by agreeing to community service and six months of probation. A letter from the U.S. attorney describing his alleged illegal act would go to his ROTC commanding officer. Foral feared that his professional future might be compromised.

Security restrictions are old hat to physical scientists, who have been dealing with similar constraints since the dawn of the nuclear age, but they are new to biomedical researchers, who have previously had to cope only with regulations affecting public health and safety. Despite security constraints, U.S. physics prospered during the Cold War, and biology may flourish similarly in the future-especially since it is receiving handsome funding ($1.5 billion to the National Institutes of Health in fiscal 2003) for research into bioterrorism.

But the new restrictions, and those on the horizon, may pose difficulties for contemporary biology that are far more chilling than those that beset early Cold War physics. The current constraints on foreign students and visitors in the name of national security have already worked “serious unintended consequences for American science, engineering, and medicine,” according to the presidents of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine, in a December 2002 statement protesting the government’s policies. Censorship of sensitive unclassified research threatens worse effects, by menacing open communication in numerous biomedical areas-including the study of disease and the immune system. It could thus, some experts charge, threaten researchers’ abilities to engineer therapies and cures-and that could place the very competitiveness of the nation’s biotechnology industry in peril.

Physicists became enmeshed with national security when they built the atomic bomb in World War II and then committed themselves to maintaining nuclear superiority during the Cold War. The key object of control was information: how to obtain fissionable fuel for atomic bombs, and the workings of the bombs themselves. No one disputed that research on nuclear weapons or access to such research had to be restricted to scientists who would not risk national security by releasing classified information, either inadvertently or through espionage.

That logic was sensible on its face, but how to make it operational was highly disputed in the tense, early years of the Cold War. Communism was understood to be an international conspiracy, demanding loyalty to the Soviet Union from its adherents everywhere. The revelations of the espionage committed by the nuclear physicists Alan Nunn May and Klaus Fuchs indicated that the conspiracy reached into the heart of the nuclear-weapons enterprise in Canada and the United States. In 1947, to defend against Communist infiltration of the government, the Truman administration began requiring loyalty checks for all federal employees. The policy affected almost 60,000 U.S. scientists and engineers.

In that politically fraught climate, which yielded Senator Joseph McCarthy’s reign of ideological terror, the line between liberalism and Communism was blurred, often making liberals suspect as security risks and opening their activities to scrutiny by FBI investigators. Lengthy security-clearance investigations could cost scientists months of anguish and unemployment. For some, past or present political associations led to the denial of clearances or to confinement to unclassified research. For others, they produced public castigation, like the House Un-American Activities Committee’s unwarranted denunciation of the physicist Edward U. Condon, the head of the National Bureau of Standards, as “one of the weakest links in our atomic security.”

Worries about security led the government even to cloud the distinction between practitioners of classified and unclassified research. In 1950, some conservative congressmen tried to require security clearances for all researchers receiving fellowships from the proposed National Science Foundation. They failed, but that same year the Joint Committee on Atomic Energy successfully imposed the requirement on all applicants for Atomic Energy Commission fellowships, whether they would be engaged in classified research or not. There is always the chance, declared the conservative Republican senator William Knowland, that some student, even if engaged in nonsecret studies, might “hit upon a super-duper atom bomb and be off to Russia.” The State Department, determined to protect U.S. atomic secrets against suspicious foreigners, denied the Nobel laureate Paul Dirac, a member of the British atomic-energy effort but in the 1930s a frequent visitor to the Soviet Union, a visa to attend scientific congresses in the United States. It also refused the homegrown chemist Linus Pauling, an outspoken liberal, a visa for travel abroad.

Some scientists protested the assaults on civil liberties. “The opportunity of the young scientist to develop his ideas should not be purchased at the expense of his human dignity,” Albert Einstein said. But the security issue left President A. N. Richards of the National Academy of Sciences cowed. Explaining the academy’s refusal to come vigorously to Condon’s defense, Richards said that “the most unfortunate outcome would be to jeopardize our relations with government.” And as the Cold War intensified, many scientists came to consider Communism a sufficient threat to U.S. security to warrant the curtailment of civil liberties.

Harvard University president James B. Conant, a key figure in atomic policymaking and a liberal on most domestic matters, was typical. Conant waffled on the Condon case, and in December 1948, several months after the Communist takeover of Czechoslovakia, he said, “It must be recognized that quite apart from the possibility that some individuals might be connected with this [Communist] conspiracy, others who are quite innocent of any such ties are nevertheless temperamentally naive and indiscrete and cannot be trusted with confidential information in spite of their excellent intent and high ability. The government, in resolving doubts on these matters about employees, including scientists, must settle the case in favor of the government rather than the individual. If a shadow of doubt exists, the individual should be prevented from having access to confidential information.”

Like physicists during and after World War II, many biomedical scientists today are eager to help strengthen national security. In June 2002, a committee of the National Research Council published Making the Nation Safer: The Role of Science and Technology in Countering Terrorism, which laid out a variety of research agendas, including one in the area of human and agricultural health. Microbiologists have often been casual in managing lethal agents, keeping anthrax, for example, in glass tubes on bench tops in unlocked labs. Most biologists today seem to consider reasonable the requirement that anthrax samples be inventoried and locked up.

But many microbiologists worry that the new security regulations may be counterproductive not only to basic research and biotechnology but even to the defense against bioterrorism. Ronald Atlas, president of the American Society for Microbiology, has noted that “some researchers are now afraid to be anywhere near an anthrax culture,” and that many academics are destroying their restricted agents to be sure of avoiding prosecution. Gary Bass, executive director of the nonprofit OMB Watch, which advocates greater access to government information, has observed, “We have a basic principle of right to know in this country. It is shifting, ever so subtly, to becoming one based on a need to know.” Robert Iuliano, acting vice president and general counsel at Harvard, told me recently that many faculty members worry how the restrictions on foreigners may affect the openness of the campus-for example, the accustomed freedom of undergraduates, no matter their national origins, to visit any laboratory. An essential and troubling question facing American scientific leaders is how to help defend the country without damaging the vitality of basic research, biotechnology, and, indeed, higher education.

The National Academy of Sciences has been far more publicly active in dealing with the question now than in the postWorld War II decade. The American Society for Microbiology has also weighed in powerfully on security issues. It has commanded attention by reason of its size-42,000 members-and of the tireless outspokenness of Atlas, an environmental biologist with experience at the intersection of science and policy. After September 11, Atlas was inundated with inquiries from scientists, government officials, and the media. “At the height of the anthrax attacks,” he told me in a recent e-mail, “I was handling 70 press calls a day. I had to have two secretaries working full time to screen calls.” Academic scientists were not consulted when security restrictions were inserted into the USA Patriot Act; Atlas felt they ought to have been.

Still, U.S. scientists are not toiling in the same atmosphere of suspicion that they endured during the Cold War. None is accused of being a risk to national security, the way some physicists were in the heyday of McCarthyism; none needs fear being branded a subversive simply for speaking out in defense of open and accessible biomedical science. And so they have been able to publicly take issue with the new restrictions.

But in several ways today’s biologists face more difficult obstacles than physicists did in the early Cold War. Then, a scientist was made suspect by his or her political affiliations. In principle, suspicion could be allayed by repudiations of past political behavior and renunciation of current allegedly dubious activity. In contrast, what makes a scientist suspect today is his or her nationality, which is difficult to modify, or ethnicity, which is unchangeable. There is no appeal against the denial of access to selected biological agents on the basis of nationality; it applies absolutely without exception.

Foreign students are now subjected to close scrutiny in applications for visas. The State Department reportedly asks all male applicants between the ages of 16 and 45 whether they have any experience with biological weapons or have participated in armed conflicts. (Of course, a would-be terrorist would just lie, but discovery of the lie would provide grounds for prosecution and expulsion from the country.) Requests for visas, especially by male students from Arab and Muslim countries, and by anyone bound for scientific activities, often meet with lengthy delays. A number of foreign students home on vacation after having been previously admitted to the United States have found themselves stuck awaiting reentry; one doctoral candidate at Yale University who went home for the holidays in December 2002 had to wait so long for a visa that he missed the spring semester.

Visa delays and denials have already interfered with or caused the cancellation of important international conferences, disrupted careers, and slowed research projects-including, according to media reports, an anti-HIV drug, a vaccine against the West Nile virus, and sensors to detect biowarfare agents. In the long term, they could jeopardize the nation’s research and training programs, which depend heavily on foreign students, and ultimately its economic competitiveness. According to 1997 figures, the latest available, foreign-born students represent a quarter of all U.S. PhDs in biology. The U.S. biotechnology industry draws abundantly on these trainees: between 8 and 10 percent of its employees are visa-holding foreigners, four out of five of whom trained at American universities.

Even if they negotiate the visa gauntlet, foreign students may find themselves investigated by the FBI if they are working in potentially dangerous biomedical research. Critics worry that under the broad terms of the USA Patriot Act, the government might claim authority to pry into student records and e-mail accounts. Visa-holding Muslim students have been complaining of harassment on their return to the United States from vacations. Students from countries believed to sponsor terrorism are fingerprinted, photographed, and required to check in periodically with the government. In an interview with the Chronicle of Higher Education, Omar Afzal, who advises Muslim students at Cornell University, said, “They are terrified. They come from a culture where if a policeman shows up at the door, you are being targeted to be sent to prison for a long time.”

Beyond visa considerations, biomedical scientists have found especially disturbing the prospect of restrictions on the practice and publication of so-called sensitive research. In nuclear research, a line could be drawn between research that was and was not integral to national security. If the investigation of fissionable nuclei was crucial to national defense, research into the nuclei in most of the periodic table was not. It remained open and unclassified.

In contrast, the line in biomedical research is blurred, because results in almost any area of basic molecular biology may be fuel for bioterrorism. The problem has been illustrated by several recent publications. Early in 2001, in an article in the Journal of Virology, Australian scientists reported that the insertion of a gene into the mousepox virus had unexpectedly made the virus lethal to mice previously resistant to it. Intended to make mice infertile, the experiment suggested how to engineer human viruses to bypass the immune system. In a paper in the Proceedings of the National Academy of Sciences, in June 2002, Ariella Rosengard of the University of Pennsylvania described the synthesis of a protein in the smallpox virus that presumably enables it to evade the immune system. The next month, Science published a report by a microbiologist at the State University of New York at Stony Brook, detailing how to assemble a poliovirus from scratch using commercially available chemicals and DNA synthesis machines.

The mousepox paper was criticized when it appeared as providing a how-to guide for terrorists; after the anthrax attacks, Atlas recalls, its publication was attacked as a huge mistake. And in Congress, according to Science magazine, eight Republicans criticized the poliovirus publication as a “blueprint that could conceivably enable terrorists to inexpensively create human pathogens,” and they called on journal editors to take greater care in what they published. Officials in the Bush administration reportedly suggested that biologists employ the practice adopted by cryptographers-voluntary submission of possibly sensitive papers to sponsoring government agencies prior to publication. Some observers note that academic scientists are already willing to accept restrictions on publication imposed by industrial sponsors. Why not concede to restrictions from government sponsors?

To many, the idea seems impractical. In contrast to, say, the Journal of Cryptology, which publishes fewer than 20 papers annually, the 11 journals sponsored by the American Society for Microbiology alone put out 6,000 papers a year. But far more important is the fact that a good deal of biomedical research is double purpose: it may assist bioterrorism, but it can also help defend against it and serve the needs of civilian and military health. Craig Venter, the former president and spark plug of Celera Genomics, told a reporter, “Some people argue that publishing each genome is like publishing the blueprint to the atomic bomb. But it’s also the blueprint for a deterrent and the blueprint for a cure.” In an interview with the Chronicle of Higher Education, Ariella Rosengard, defending the publication of her paper on the smallpox protein, declared, “We need to galvanize the scientific community to develop safer vaccines and therapies, not make it so difficult that scientists say there are so many restrictions that I’m going to study something else. Because then the terrorists really do win.”

The dual use of biomedical research helped block a Bush administration proposal to move the bioterrorism work of the National Institutes of Health into the new U.S. Department of Homeland Security, though the two will collaborate to create a bioterrorism research agenda. But the publication issue still looms large. The American Society for Microbiology’s journal editors have sought to develop policies that would serve the purposes of both bioterrorism defense and the eradication of infectious diseases. The key policy, adopted in early 2002, was to vet papers for possible hazards-with the aim of raising any problems with their authors-before sending them out for review. Several authors decided on their own to withhold sections of papers for fear of revealing sensitive information to potential terrorists, appealing to the precedent set in 1940, when a number of nuclear physicists voluntarily established a system to suppress the publication of research on defense-related subjects such as uranium.

But the journal editors soon found themselves fielding complaints that the papers lacked adequate information for replication of the reported experiments. Atlas wanted to ensure completeness in scientific publication, but he understood the need to avoid publishing “cookbooks” for bioterrorism. Besides, he worried that the appearance of such recipes in the journals might provoke a government crackdown. Not sure how to proceed, Atlas prevailed on the National Academy of Sciences to call a meeting where biomedical scientists could discuss the issue with federal security experts.

The meeting, held at the academy on January 9, 2003, revealed, as the president’s science advisor John Marburger put it in prepared remarks, that past policies appropriate for security in nuclear physics “do not give adequate guidance for the technology of bioterrorism.” The proceedings were cosponsored by the Center for Strategic and International Studies, a Washington, DC, think tank, and they pitted scientists, who on the whole insisted on the freedom to publish-even articles like the mousepox, smallpox, and poliovirus papers-against federal security experts, who considered such research sensitive and its publication downright dangerous. George Poste, the chair of a Department of Defense task force on bioterrorism, insistently told the gathering, “I do not wish to see the coffins of my family, my children and grandchildren, created as a consequence of the utter navet, arrogance, and hubris of people who cannot see there is a problem.” Gerald Epstein, of the Institute for Defense Analyses, an Alexandria, VA, think tank, wondered how the scientists would like it if a sensitive article were “found in a cave in Afghanistan with sections highlighted in yellow.”

If some of the rhetoric sounded inflamed, both sides soberly recognized that the issue involved high stakes-both the nation’s security and the possibility of “blanket restrictions on science,” to quote John Hamre, a former deputy secretary of defense and now president of the Center for Strategic and International Studies. In a recent conversation, Hamre explained, “If the scientific community doesn’t take the lead in dealing with the reality of the bioterrorist threat, the security community will take over and do the job in ways that are likely to be wrong.” He added that “no group is better qualified than biologists to figure out what biomedical research might be dangerous to publish.” At the meeting itself, Marburger stressed that the government needed the help of biologists in identifying and censoring truly sensitive research results.

In a statement issued after the meeting that made clear their willingness to help, Atlas, Thomas Shenk (his successor-elect at the American Society for Microbiology), several other officers of scientific societies, and the editors of a dozen leading journals, including Science, Nature, and the New England Journal of Medicine, declared that scientific manuscripts must be published in “sufficient detail to permit reproducibility.” But they went on to say that editors must be watchful of information that might be dangerous in the wrong hands, and that papers likely to generate more harm than benefit should be changed or not published.

Glossing the policy for me, Atlas said he considered it “a call for integrating ethics” into the criteria for scientific publication, a modification of peer review standards to “take into account protecting the public” as well as the quality of the research. He stressed that the refereeing process is “out of government control and hence not a system for censorship. In the end it will be up to the public to see if that is adequate.” A few weeks after the statement was issued, Bruce Alberts, the president of the National Academy of Sciences, remarked to the Washington Post that the biomedical community was “on the right track” with the problem of biosecurity. “We need to be on the same team with the security folks instead of in opposition.”

Cooperation, though, runs the risk of co-optation. Early Cold War scientists, eager to protect national security and their influence in federal policymaking, often wound up supporting the government’s curtailment of their colleagues’ civil liberties. And in any event, the earnest tightrope-walking of U.S. journal editors may well be beside the point. Unlike early Cold War nuclear physics, which was confined to a handful of countries, contemporary biology is a global enterprise. In an unsigned editorial, The Lancet Infectious Diseases noted, “No government will really ever be able to control the flow of scientific information. There are 5,000 or more journals in the world, and the Internet is available to anyone who wants to use it.” And locking up lethal biological agents is perhaps as difficult as locking up information about those agents. In the early Cold War, controlling uranium and plutonium was much easier. Raw uranium ore was hard to obtain, and turning it into fissionable fuel involved large, costly processing plants and reactors. But the agents of bioterrorism require comparatively small-scale production plants. Moreover, they are ubiquitous in their natural forms, and new forms-not to mention old ones like the poliovirus-whose DNA sequences are readily available on the Internet can be manufactured using automated tabletop technologies. As Gigi Kwik, a fellow at Johns Hopkins University’s Center for Civilian Biodefense Strategies, noted, “You can now finish before lunch projects that used to consume a PhD thesis.”

There thus seems little to prevent determined terrorists from obtaining or engineering lethal agents that fall under security restrictions-or from devising new ones. Similarly, keeping foreign doctoral students out of American universities won’t necessarily do much to prevent would-be terrorists from acquiring useful technical skills. Universities in Europe and Asia are producing a growing number of science and engineering doctorates and are responsible for half the world’s biomedical research. Bruce Alberts told me recently, “None of these efforts to control the weapons of bioterrorism will work without international cooperation. It’s really imperative, given how much biology is done outside the United States.”

As TR went to press, the federal government had not restricted publication of sensitive basic research, but a chill has already fallen over biomedical science. Evident in the constricted flow of foreign students and visitors, as well as in the impairment of some research programs, it is provoking apprehensions that biomedical research and biotechnology could be weakened by the drive for secrecy and security-and weakened without significantly, if at all, limiting the capacities for bioterrorism.

To read about the effect of anti-terrorism measures on international students at MIT, read Is MIT a Security Risk?

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