Nearly three years ago, the federal government gave Nancy Connell the green light to investigate how people respond to infection by Bacillus anthracis, the bacterial agent that causes anthrax. With $3 million (US) from the Department of Defense, Connell hoped to learn how to detect the bacteria within hours of infection. But thanks to the hurdles put in her path, it took until this past July for Connell to get her hands on the bacterial strain for her study. Today, her team at the Center for BioDefense at the University of Medicine and Dentistry of New Jersey works 12-hour days to make up for lost time.
"It was a really long wait and a frustrating wait,'' said Connell, the center's director. Connell's predicament--and similar ones of other scientists--raises questions as to whether the federal government is working at cross-purposes in its effort to fight bioterrorism. As the National Institutes of Health prepare to spend nearly $2 billion on bioterrorism research, Congress, the military, and commercial organizations have tightened restrictions for getting the strains scientists need to conduct their studies.
Government officials say precautions are necessary in a post-Sept. 11 world, where anthrax attacks last autumn killed five people, and where allowing dangerous bacteria to fall into the wrong hands could lead to similar, or even worse, tragedies.
"The frustration is absolutely there,'' acknowledged Carole Heilman, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID). "We recognized this would be an issue at the beginning, and we told the [scientific] community we would try to establish a repository [of bacterial strains]. Will it happen tomorrow? Absolutely not.''
FUNDS, RED TAPE APLENTY In the new 2003 budget, the NIH will get $1.8 billion to encourage scientists to study potential agents of terrorism such as anthrax. One of the government's first responses to last year's anthrax attacks was to direct money to the Institute for Genomic Research (TIGR) in Rockville, Md., to speed TIGR's genomic analysis of at least 14 strains of B. anthracis. The project will create a database of genomic information to help researchers learn more about the genetic variability that causes differences in the biological properties of individual strains.
But even as the government encourages such research, there are reports that government may also be a hindrance. At the moment, the NIH requires research results be made public. Recent developments, however, leave scientists wondering about the ease of future biodefense research, and the public availability of research results.
When Congress last fall passed the Public Health Security and Bioterrorism Response Act of 2001, one provision tightened regulations for select agents--a special designation for 36 dangerous pathogens, such as B. anthracis, that requires background checks and security clearances before scientists can use them. Congress began tracking the transfer of these pathogens in 1997, after microbiologists Larry Wayne Harris of Ohio and William Leavitt of Nevada were charged with possessing anthrax for use as a weapon.
The congressional act expanded the list of regulated agents to nearly 60. It required anyone possessing such agents to register with the Centers for Disease Control and Prevention, and it called for new regulations for handling such agents. Because the government is still writing the regulations, it is impossible to say how restrictive they might be, says Janet Shoemaker, director of public and scientific affairs for the 42,000-member American Society of Microbiology (ASM). The Bioterrorism Act, for instance, calls for labs to implement new security measures while working with select agents. Just how costly, cumbersome, and intrusive those measures might be will remain unclear for some months.
"There's a political reality here that has to be faced by our community,'' Shoemaker said. "We hope the rules of reason and common sense will prevail as these regulations are developed so we don't regulate this research out of existence.''
TIGHTER SECURITY Efforts are under way to tighten regulations elsewhere: In New Jersey, where the state health commissioner assembled a panel to evaluate transportation of select agents, some are proposing that it be illegal to mail select agents in the state. Others are talking about using police escorts. Some biology journals were reportedly under White House pressure, which the White House denied, to restrict information that could be helpful to terrorists. There are worries that federal agencies may assess the risks of research before agreeing to fund it, may deem new areas of bioscience as government classified, may review work prior to publication, and may insist that the methods sections of some research papers be removed.
Some critics say such actions would stifle research that might prepare America for future bioterrorist attacks. "Questions have been coming up as to whether or not people could withhold [research] materials,'' said Ronald Atlas, president of the ASM. "Once you publish [research findings], others [should] be in a position to repeat the work.''
Connell's experience also raises the question whether scientists seeking dangerous bacterial strains must now go through the nation's military, which for many can be a daunting and lengthy process. After Connell acquired select-agent status, which took the better part of a year, she first tried to get B. anthracis strains from the American Type Culture Collection (ATCC), which houses one of the world's largest supplies of bacteria samples. After filling out complicated applications and undergoing rigorous reviews, Connell discovered nearly two months into the process that the ATCC was no longer shipping select agents.
While the organization still maintains select-agent donations, "We have just elected not to distribute it,'' said Nancy Wysocki, the ATCC's vice president of human resources and public relations, who would not elaborate on the reasons. Observers say the decision was based on fears of liability should the shipped materials be used for bioterrorism.
It was nearly winter of 2001, so Connell turned to the US Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md. "We had to do a lot of very complicated paperwork involving lawyers,'' Connell says. "We were pretty much ready to go, and all of a sudden, [the Army] put a hold on shipping out organisms. We waited until July [of 2002], and finally they released the organism.'' The Department of Defense did not return a phone call seeking comment. One scientist who asked not to be named says: "Doing an experiment with the Army just takes forever. There are layers and layers of approvals.''
The ATCC's refusal to ship select agents also complicates the work of Tom Montville, a professor of food microbiology at Rutgers University, who is applying for funds from the US Department of Agriculture and the Food and Drug Administration to develop research surrogates for B. anthracis. Montville contacted one government lab that maintains a nonpathogenic strain of B. anthracis, but "they wouldn't even answer my E-mail,'' he said. "I think ... everybody is scared to hell. The only way to get these strains now is to know someone who has them. At some point, [such restrictions] will impede research to the degree that only terrorists will have the cultures.''
Connell believes some government restrictions are necessary, but so is collaboration. "It's a new era, and we need to feel our way,'' Connell said. "If we can actually coordinate our efforts, ... we can enter into a new age of working with these organisms in a safe manner.''
Dana Wilkie (email@example.com) is a Washington, DC, correspondent for Copley News Service.