Published online 10 May 2010 | Nature | doi:10.1038/news.2010.231

News

Regulations increase cost of dangerous-pathogen research

More people are studying 'select agents' despite red tape.

Cumbersome rules have driven up the cost of working with pathogens.J.Gathany, Centers for Disease Control and Prevention

Complex US regulations governing experiments with dangerous pathogens and toxins have reduced research efficiency, according to a study published in the Proceedings of the National Academy of Sciences1 this week. The average cost of a research paper on the Ebola virus has increased from about US$59,000 to $333,000 since the restrictive regulations were adopted in 2001–02.

But more researchers have entered the field and the number of publications has increased, despite concerns from some microbiologists that regulations were driving talented scientists away (see Driven out of research).

"Some of the worst fears about regulation becoming so intrusive that things couldn't get done have probably not been realized," says Kenneth Berns, a virologist at the University of Florida, Gainesville, and a member of the National Science Advisory Board for Biosecurity in Bethesda, Maryland.

The study, led by Elizabeth Casman of Carnegie Mellon University in Pittsburgh, Pennsylvania, evaluated the effects of two government acts on biomedical research — the Bioterrorism Preparedness and Response Act of 2002, and the USA PATRIOT Act that was passed about six weeks after the terrorist attacks on 11 September 2001. The two laws limit research with 'select agents' — pathogens such as Bacillus anthracis and toxins such as ricin that could potentially be used as bioweapons — and their measures include researcher background checks and training, protocols for handing the agents and extensive documentation at every stage of the research.

Some researchers decried the regulations, saying that they went too far and would smother the research needed to understand and develop treatments for biothreats. "We all agree that we need to be careful," says Arturo Casadevall, a microbiologist who works with B. anthracis at the Albert Einstein College of Medicine of Yeshiva University in New York. "But it is very difficult. The paperwork required is enormous."

In a survey published in 2009, 64% of 198 biodefence researchers reported a high level of concern that they might unintentionally violate the regulations and damage their careers in the process2.

Bureaucratic tangle

In the latest research1, Casman and her colleagues gathered data on research publications involving two select agents: the Ebola virus and B. anthracis. They found that most researchers had started working with the pathogens after the biosecurity regulations were enacted, suggesting an influx of scientists into the field — even after accounting for a natural rise in research due to funding increases for the work.

This trend was not seen with authors of publications about Klebsiella pneumoniae, a bacterium that can infect people with weakened immune systems. Although concerns about the spread of antibiotic-resistant K. pneumoniae have stimulated research in the field, the bacterium is unlikely to be of use to terrorists and is not a select agent.

The number of collaborations for research into Ebola virus and B. anthracis — within the United States and internationally — has also grown, although international collaborations occur with fewer countries now that the biosecurity regulations are in place.

Despite these gains, there are signs that the procedures are a burden on the research community. Before 2002, there were 17 papers published on Ebola research for every $1 million spent. This fell to three papers per $1 million after 2002. The average number of K. pneumoniae publications fell only from 26 to 17 under the same conditions.

Case for streamlining

One problem with the policies is that some were based on the measures used to regulate nuclear-weapons research, says Vickie Sutton, director of the Center for Biodefense, Law and Public Policy at Texas Tech University in Lubbock.

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For example, regulations require researchers to create an inventory of each sample of a select agent and to document any changes. A missing test tube would draw immediate attention from the US Centers for Disease Control and Prevention, says Sutton. But the system does nothing to prevent the use of samples withdrawn from a live culture to seed a new culture. "You could every day be giving this agent out to someone," she says. "It's nonsense."

Nevertheless, studies such as Casman's strengthen the case for streamlining the regulations. Some important steps have already been taken, says Casadevall. In 2008, for example, the US Department of Agriculture removed several plant pathogens from the select-agents list after they were deemed by researchers to pose little threat. "I'm optimistic that we'll work this out," he says, "but it will take time." 

  • References

    1. Dias, M. B., Reyes-Gonzalez, L., Veloso, F. M. & Casman, E. A. Proc. Natl Acad. Sci. USA advance online publication doi:10.1073/pnas.0915002107 (2010).
    2. Sutton, V. Biosecur. Bioterror. 7, 225-226 (2009). | PubMed |

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  • #61325

    I think the security situation in states with former offensive biowarfare programs is particularly troubling.

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