By David Ruppe
Global Security Newswire
WASHINGTON — Congressional leaders may soon address a proposed law that critics say would reduce the U.S. military’s obligation to inform soldiers about the health risks of unlicensed biological defense drugs and vaccines they might be required to receive in an emergency.
The provision, contained in the House version of the Project Bioshield Act of 2003, would allow officials to respond to some emergencies by administering drugs to the nation that have not been approved by the Food and Drug Administration.
The law would require officials to inform potential drug recipients of the drug’s potential health risks and to get the recipients’ consent to administer the drug, but it would also permit the president and other senior officials to waive these requirements when delivering the drugs to U.S. military personnel.
Representative Christopher Shays (R-Conn.) recently criticized that provision.
“I am concerned that certain provisions of section 4 of the bill will unfairly treat the men and women of our armed services,” he said in a July dialogue with House Committee on Energy and Commerce Chairman Billy Tauzin (R-La.).
Existing federal law, that Shays helped draft following the 1991 Gulf War, already permits the president to waive the consent requirement for military personnel if obtaining consent is infeasible, contrary to the best interests of the individual, or not in the interests of national security. In addition, the law requires that potential recipients must be told that they have the right to refuse the drug, although they might be discharged from the military or jailed if they do so. It furthere requires that all recipients be first informed of the product’s unapproved status and of its potential side effects.
Under the proposed changes, the president would continue to be able to waive the consent requirement, but he would also be able to waive the requirement to notify potential recipients that they may refuse the drug. Furthermore, the Health and Human Services secretary could authorize delaying the notification of recipients of their potential health risks. The proposed law says the information would be provided to the drug recipient, or next-of-kin in case of a death, no later than 30 days after the individual received the drug.
Steve Robinson of the National Gulf War Resource Center, a veterans group, opposes the new language.
The military will say it’s “for the cause of good order and discipline, because if one person said ‘no,’ a thousand could. But we’re supposed to be the kind of society that evolves and I think our soldiers are smart enough to at least be told of the risks and, in certain cases for certain drugs, have a choice,” he said.
Tauzin said the disputed provision was intended only to eliminate an individual’s right to refuse a drug, not to deny drug recipients information on potential health risks, except in “extraordinary circumstances.”
Tauzin said his committee reviewed the language and found it could be confusing.
“We intend the waiver authority in this bill to be used only in the very extraordinary circumstances that we describe in the bill,” he said.
Tauzin said he would work with Shays “to make sure that the final version of this bill from the conference that we will have with the Senate, I am sure, provides that our military are informed of the drugs that are given before these drugs are administered.”
By Neil Munro
National Journal
Periodically, huge infestations of mice burst across Australian farmlands, destroying crops and livelihoods. With the government perpetually looking for new ways to control the plagues, a small group of Australian scientists published a new method for killing millions of the vermin.
But the recipe, which appeared in the February 2001 issue of the Journal of Virology, could be modified by terrorists to kill millions of humans. It showed scientists around the world how to supercharge diseases such as smallpox by tinkering with a gene, Interleukin-4. The article caused an uproar in scientific circles because of its possible terrorist uses but received little attention in official Washington. Perhaps the muted reaction was the result of an impenetrable title: “Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox.” Washington’s reaction also owed something to policy makers’ long-standing willingness to allow scientists to regulate themselves.
But 9/11, the anthrax attacks on Congress, and the ever-present threat of bioterrorism are changing that attitude. Government officials are growing more worried that scientists’ new “recipes” could fall into the hands of terrorists reading the science community’s online journals. In March 2002, the White House sent a memo to Cabinet chiefs saying that the protection of scientific “information from inappropriate disclosure should be carefully considered, on a case-by-case basis.” Last October, the House Science Committee held a hearing on science and security. And in August, Representative Nick Smith (R-Mich.) chairman of the Research Subcommittee, said his panel would watch for the publishing of data from government research studies that would leave “us more vulnerable.”
The science community now finds itself under increasing pressure from Washington to reduce the chance that one of its articles will “end up in a cave in Afghanistan with yellow highlighter all over it,” explained Donald Kennedy, editor of Science, a journal of the American Association for the Advancement of Science.
Scientists see two threats. The first is a plague that could slaughter millions of people in a world made small by air travel and global commerce. The second is a political backlash that might come even before the plague and that could curb the competitive hunt for breakthroughs, new therapies, and technologies, while limiting the improved professional opportunities that come with such advances.
To reduce both threats, the private National Academy of Sciences, which regularly helps the federal government on scientific and technical matters, has formed a panel of top scientists to consider scientific practices. The practices under scrutiny include the open publishing of discoveries, the sharing of disease samples, and the widespread recruitment of foreign scientists for low-paid research jobs in labs. Biologist Gerry Fink heads the panel.
Early this year, NAS officials also joined editors of prestigious biology journals in promising to act cautiously when publishing studies that could be used by terrorists. “We’re really doing a very careful balancing act” that weighs too little caution against too many controls, said University of Louisville professor Ron Atlas, then-president of the American Society for Microbiology, which owns the Journal of Virology. “If we are not careful, then science does not advance and we don’t get the cures we need.”
The stakes are extremely high, and not only because of the bioterrorism threat. The sprawling debate over professional self-governance will also shape the way the United States and the world manage such high-impact endeavors as human clinical trials, genetic engineering, and cloning, each of which carries potential benefits and risks. “There’s a 50 percent risk of a severe setback to civilization by the end of the century,” says Martin Rees, a well-regarded astrophysicist at the University of Cambridge who also holds the title of Astronomer Royal. The risk exists partly because the diffusion of scientific knowledge allows a few people to wreak great damage, Rees said, but also because “for the first time, human beings themselves are going to change [on account of] genetic modification, targeted drugs, and even implants in the brain.”
In the face of such risks, he said, “all we can hope for is emollients, and not even pleasant ones.”
Life in the Lab
Scientists’ motivations and values affect the science community’s ability to govern itself. “The strongest motivation for scientists is being respected by leaders” in science, said Bruce Alberts, president of the National Academy of Sciences.
“We care a lot about how other scientists think about us, and we don’t care a lot about others who are not scientists.”
Scientists win respect through competitions to publish or criticize papers, to patent lucrative discoveries, and to lengthen their resumes, some of which run longer than 20 pages. Harold Varmus, who directed the National Institutes of Health under President Clinton, described in the June 7, 1999, issue of The New Yorker his own emotions when working in the laboratory:
“There are a lot of juices flowing as you work in the lab. So many things are at stake! Careers, competition, people’s ideas of how the world works. And then succeeding at the bench gives you this incredible rush that is high up there on the scale of human pleasures.”
This intellectual environment fosters many shared values among scientists worldwide, creating “a special clan, a family who have a special allegiance to each other” regardless of nationality, Alberts said. “We can appreciate a wonderful piece of work done in Japan or Iran for its own elegance.”
Scientists’ allegiance to the clan helps them manage routine issues within their community, including fraud, human error, workplace safety, and the allocation of resources. This self-policing, buttressed by scientists’ almost complete reliance on one another for grant recommendations and awards, ensures that those who deceive their colleagues are “done,” said Mary Good, former undersecretary of technology in the Clinton-era Commerce Department.
The result of such clannishness, Alberts said, is that the community can punish those who go against its values. He cited Carl Sagan, a noted scientist who achieved fame in the 1980s by hosting popular TV documentaries. Other scientists, however, criticized Sagan as being “too immodest in seeking other kinds of community accolades,” Alberts said. This distance from the larger community is also visible in the area of religion. Only 7 percent of 517 NAS members declared a belief in a God, according to a survey published in 1998 by the journal Nature. Yet 59 percent of Americans said that religion is very important in their lives, according to a poll released in December by the Pew Research Center for the People and the Press.
In a sharper departure from mainstream thinking, some scientists favor research in pursuit of the technological evolution of humanity — and sometimes even its replacement by new forms, such as vast networks of highly intelligent robots. These advocates include highly respected scientists, such as Mihail Roco of the federal National Science Foundation, who is a leader of the government-wide nanotechnology program, and Hans Moravec, a government-funded robotics scientist at Carnegie Mellon University.
Roco proposes “the right of each individual to advance” with the aid of technology, and Moravec welcomes the replacement of humanity. “Rather quickly, [robots] could displace us from existence,” Moravec wrote in an article posted on his Web page in 2000. “I consider these future machines our progeny, ‘mind children’ built in our image and likeness ... It behooves us to give them every advantage and to bow out when we can no longer contribute.” In February, Moravec formed a company to sell robots for labor-intensive tasks, such as driving forklifts. (His December 2000 paper estimates that there are more than a million forklifts in the United States.)
Indeed, most scientists adopt utilitarian perspectives on ethical and political questions, and they use their values to estimate costs and benefits. But society often trumps such utilitarianism, Alberts said. As an example, he noted that science could learn much by experimenting on death-row inmates — a practice that was widespread with ordinary inmates until public opposition ended it in the 1970s. “If it was purely up to scientists, they might accept the idea of doing experiments on death row,” Alberts said. “The person will be dead in six months anyway.”
This utilitarianism is reflected in the way scientists approach lobbying. When asking for funding or trying to fend off regulation, science advocates normally promise to deliver jobs and cures. And scientists have successfully preserved much legal authority for themselves. Every year, panels of scientists assembled at the National Institutes of Health or at research universities adjudicate tens of thousands of requests for federal grants and thousands of proposed medical experiments. In the vast majority of these cases, the panels enforce various federal laws, especially those dealing with human experimentation, without fuss or controversy.
But sometimes the panels fail to protect patients and provoke regulatory intervention: On July 3, NIH’s Office for Human Research Protections condemned multiple universities and research centers for failing “to include death as one of the risks” when asking patients or their guardians to join a study of alternative therapies for acute respiratory distress syndrome. According to critics, including the New York-based Alliance for Human Research Protection, the experiment resulted in the deaths of some 37 patients.
Scientists vary in their willingness to accept direction from the public, said Kennedy. Some scientists champion public oversight and think they “ought to have a sense of responsibility to that public.” Others, Kennedy said, “don’t think the laity ought to be telling them what to do.” This mixed perspective stands in contrast to the near-universal expectation among scientists that politicians should boost spending on science, base more decisions on science, make more use of the NAS, and re-establish Congress’s Office of Technology Assessment.
When scientists do listen to public concerns, it’s often unclear whether they are motivated by a selfless ethic or by the fear of public intervention. Both motivations come into play, Alberts said, and he cited as an example the 2002 NAS report urging a temporary ban on efforts to clone a human for birth:
“The reason we got so many people to work on that report [was fear that flawed cloning attempts] would have the same kind of effect as the mad-cow disaster has had on the respect and support for science” in the United Kingdom. In the 1990s, British scientists received much of the blame for the spread of mad-cow disease and the exposure of citizens to this ghastly and fatal illness. Since then, the British public’s opinion of science has fallen sharply, fueling several other controversies over science-related issues, such as the safety of vaccines and genetically modified crops. In many cases, scientists’ ethical concerns do coexist with self-interest. “We’d all be haunted if some publication in my [NAS] journal were used to make a biological weapon,” Alberts said.
Closing the ‘Cookbook’
The science community’s efforts to head off the threat of bioterror have been extensive but, critics complain, inadequate.
In February, 32 senior scientists and science journal editors called a press conference to announce new procedures for reviewing articles that might contain information of value to terrorists. Scientists said that these new standards would affect very few articles. Atlas, the former president of the American Society for Microbiology, said a review of 14,000 articles sent to the ASM in 2002 identified 224 that raised “surface questions,” but only two needed to be modified because they contained “cookbook” information detailing ways to make bioweapons. “We do not want to release information if we see greater danger than benefit,” Atlas said.
Pentagon officials are free to classify research they have paid for. However, science advocates maintained, the Pentagon should not try to curb sensitive but unclassified information. Atlas and the editors rejected a suggestion to exclude a broader range of cookbook information. Such information is needed, he said, to let other scientists verify claims and to avoid the wasteful pursuit of false leads. Also, much information — including the workings of the Interleukin-4 gene — has multiple uses, many of them beneficial, and this multiplicity increases the payoff from wide distribution of research.
Atlas pointed out that the international science community is far larger than it was during the Cold War, when a cadre of nuclear physicists closely held data on nuclear weapons. For example, the ASM, which is one of many biology societies, has 42,000 members, with almost one-third of them outside the United States. Because of the vast scope of the science community, scientists must rely on the journals — including the ASM’s 11 — for information since they cannot create private channels for sharing sensitive cookbook information, Atlas said.
Science organizations have also emphasized compliance with existing regulations on the handling of dangerous materials, such as disease samples. “ASM members are advised to exercise prudent attention to biosafety and to be vigilant concerning unusual occurrences,” states an alert on the ASM’s Web site, asm.org. The regulations were established in 1999 and strengthened by two anti-terrorism acts, the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The preparedness act requires registration of scientists working with a select list of diseases and poisons.
These regulations met the needs of science, say science advocates, partly because science groups lobbied against tough restrictions on foreign scientists and laboratory equipment. For example, scientists persuaded congressional staff members to drop a proposal that would have barred foreign scientists and students from working in the United States. Instead, the law places restrictions on foreign scientists from only a few countries. Scientists did not get everything they wanted, such as a provision that would have allowed in any foreign scientist if given White House approval, Atlas said.
Science groups are also pressing the State Department to change visa procedures to help foreign students enroll at U.S. universities. The students provide much of the high-skill, low-wage labor employed by university scientists.
Alongside these measures, Atlas said, and in continued discussions with the White House Office of Science and Technology Policy, “we’re developing an ethos and ethical posture within the community” to ensure that the benefits of published science outweigh the risks. “Largely, that’s it. Hopefully we’re going to be OK in the broader community.”
John Marburger, the scientist who directs the White House technology office, endorsed the science community’s efforts. “The response by the journals that publish research on molecular biology and cell biology has been very good ... [although] we don’t have good indicators for the kinds of things we want to limit,” he said. Marburger added, “I’ve been impressed by how much cooperation the higher-education community has given to keeping track of foreign students.” Overall, the bioterror problem “has been such an intense topic of conversation, most people are already doing things they should do.” Early this year, the Bush administration requested for fiscal 2004 more than $1.7 billion for research intended to counter bioterror plagues, as well as additional money to improve the security of laboratories.
Will Scientists Govern Themselves?
The biological research community has its critics. George Poste, a biotech-industry executive and the chairman of the Pentagon’s Task Force on Bioterrorism, called the community “naive, arrogant, and delusional ... It is not sufficient for scientists to say ‘Just trust us,’” Poste told an interviewer for Red Herring, a technology business magazine. “If the research community doesn’t lead the debate, then the politicians will, and those well-intentioned legislative actions could damage the ability of [research] information to be used for beneficent purposes.” Poste is the chief executive officer of Arizona-based Health Technology Networks and a director at several biotechnology firms.
Atlas said, “I would not agree with the assessment at all.” Scientists have already created public panels to handle difficult issues, including debates over genetic engineering, he said, and “that worked very well [and] was very reassuring to both scientists and the public.”
These panels, however, have generated some criticism, in part because of the growth of for-profit scientific research at universities. On the issue of human experiments, critics argue that many scientists serving on the universities’ Institutional Review Boards, which review proposals for experimental treatments on people, have close ties to for-profit companies. “Almost half of all faculty IRB members serve as consultants to industry,” states a recent survey of 2,989 IRB members at 121 of the nation’s top academic medical centers. The survey, conducted by several researchers, including Eric Campbell of Harvard Medical School, was published in the August 2003 issue of the journal Academic Medicine after being reviewed by other scientists.
More broadly, “self-government is not working because [scientists] don’t accept the restraints,” said Wesley J. Smith, a left-of-center critic of the science community. In the debate over human cloning, he said, scientists try to get past public concerns by using nonscientific arguments, punishing dissident scientists, suppressing contrary data, and changing the meaning of terms. “How can we trust them when they skew what they put in their journals and skew the language?” he asked.
But Alberts cited cloning as a good example of the science sector’s willingness to govern its activities. Scientists oppose reproductive cloning, he said, but endorse cloning for experimentation because it will aid research. Curbing research for the sake of preserving human embryos “is not a reasonable way to think about humanity,” he said, partly because “many religions decide you’re a human being when you have a brain.” If an embryo does not have a brain, “it doesn’t seem to me to be a human being.”
In any debate over proposed government regulation, Alberts said, “science has an advantage because ... [advocates of regulation] have had a very hard time coming up with a method that could work without the deep commitment of the science industry.”
Although Marburger praised the science community’s role in the bioterror debate, he also endorsed regulation and oversight — partly because he said scientists are not especially expert in gauging the public consequences of their private research.
“My experience is that scientists and everyone else try to keep their work secret if they think people will complain about it, and then go ahead and do it,” he said. “That’s just human nature.”
The government and the science community need to reach out to each other, said David Heyman, director of Science and Security Initiatives at the Center for Strategic and International Studies. The national security agencies need more expertise in the life sciences, he said, and scientists need a better understanding of the terrorist threat, even at the beginning of new research projects. In the post-9/11 era, “you have a cultural change that needs to be appreciated in the life-science community ... [and] getting folks to agree on what constitutes a risk if published is the nexus of the issue.” Heyman added that some “research results, and perhaps all of them, may have a dual use” in therapeutic and terror efforts.
John Steinbruner, director of the Center for International and Security Studies at the University of Maryland, advocates a three-tier oversight system in which politicians, religious leaders, and experts on social issues would work with scientists to guard against dangerous research. At the lowest tier, panels at universities and research centers would watch over potentially dangerous activities. At the next level, national panels would oversee implementation of standards governing moderately dangerous research. At the highest level, an international body, including scientists, would have the authority to ban certain practices, such as the experimental insertion of the Interleukin-4 gene into flu viruses. “There is no good model or precedent” for oversight, Steinbruner said. But “we’ve learned that anytime a community is susceptible to bias in its own interest, and is doing things that have general consequences, there’s need for scrutiny.”
Interpol, the 181-nation international police organization based in France, has also called for change. In July, Interpol’s secretary-general, Ronald Noble, urged countries to approve new laws that would hinder terrorists’ access to critical information and laboratory equipment. Barry Kellman, the director of the International Criminal Justice and Weapons Control Center at DePaul University and an Interpol adviser, backs new “biocriminalization” efforts that would ban unlicensed research on dangerous pathogens.
The highly competitive and anti-regulatory bioscientists are adjusting to the culture shock of political demands for safeguards against bioterror, said Kellman, who worked on the NAS’s soon-to-be-released Fink report. In the scientists’ deliberations over the draft report, “the question went from whether to regulate to how to regulate,” Kellman said. Overall, “I see a lot of signs of change in a remarkably short time frame.”
Political approval for any oversight mechanism will not be easily won without the science community’s support. Some Democrats, including Represenative Henry Waxman (D-Calif.) argue that the White House is politicizing science in multiple areas, including stem-cell research and environmental studies, and that further regulation would only allow more opportunities for such interference. Many Republicans are also leery of regulation, in part because the universities work closely with businesses to boost local economic development.
Discussions about creating an oversight mechanism are in a very early stage, Heyman said. According to Steinbruner, “This dialogue does not have enough standing yet in the science or policy community for the politicians to be able to deal with it.”
“We don’t feel we’ve got the solution,” said Thomas Shenk, a molecular biologist at Princeton University and the current president of the ASM. Any solution must apply worldwide, he noted, and rapid research is still needed to deal with infectious diseases, the world’s top killers. “It is a work in progress,” he said.
The gap between scientists and national security experts remains wide, and was well illustrated by a story in the Washington Post on August 28. The piece described the science community’s growing support for Thomas Butler, a scientist who has been charged with smuggling bubonic plague samples into the United States and with lying to investigators. Butler’s supporters claim that personal transport of disease samples is common, and that the 15 felony charges are too aggressive for a scientist who “has always been lax about paperwork and regulations.” The Committee on Human Rights, a group based at the NAS, is leading the protest. The group’s chairman, Torsten Wiesel, a former president of Rockefeller University, told the Post that it is “important for the scientific community to say: This is a man we trust; see that this person is dealt with due respect.”
None of the players in the debate over scientists’ self-governance and bioterrorism could predict how it will all come out — perhaps with a compromise, perhaps with sudden intervention by the government after a terrible event. Participants in other debates on cloning, genetic research, and nanotechnology express the same uncertainty. “We never know when we find the right balance” between regulation and scientific autonomy, said one Hill staffer.
But many of the players in these debates agree on one general principle: “Society has a right to expect it will be protected from the dire effect of experimentation, especially if the science is paid for by their taxes,” said Marburger. “Their elected representatives will respond.”
The U.S. Postal Service today is expected to test a fumigation system at the anthrax-tainted Hamilton postal facility near Trenton, N.J., as part of its efforts to decontaminate the facility, according to the Associated Press. The plant has been closed since October 2001 (see GSN, April 11).
The test will involve only a small amount of chlorine dioxide gas and will pose little risk to area residents, said Postal Service spokesman Burt St. John. Chlorine dioxide gas was previously used to decontaminate other facilities contaminated by anthrax during the 2001 anthrax attacks.
If the test is successful, further tests are scheduled to occur later in the year, with full fumigation to begin in November, St. John said. Postal officials said the facility would be reopened in spring 2004 if the decontamination is successful (Associated Press/USA Today, Sept. 5).
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