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Biosecurity laws hobble research

Ever since the U.S. government has taken steps to protect and encourage research involving pathogens that could be used as biological weapons, that research has become much less efficient, according to a new analysis. Image: Wikimedia CommonsThough funding for research on so-called "select agents," or pathogens that can be used as weapons, has shot through the roof, and the number of papers using those organisms has risen in recent years, the work has become up to five times less efficient -- m

By | May 10, 2010

Ever since the U.S. government has taken steps to protect and encourage research involving pathogens that could be used as biological weapons, that research has become much less efficient, according to a new analysis.
Image: Wikimedia Commons
Though funding for research on so-called "select agents," or pathogens that can be used as weapons, has shot through the roof, and the number of papers using those organisms has risen in recent years, the work has become up to five times less efficient -- meaning, the same amount of funding produces fewer papers than it did before. "The price of the research was multiplied by maybe a factor of 5 for anthrax and maybe a factor of 2 for Ebola," said Carnegie Mellon University associate professor linkurl:Elizabeth Casman,;http://www.epp.cmu.edu/people/bios/casman.html who led an linkurl:analysis;http://www.pnas.org/cgi/doi/10.1073/pnas.0915002107 of the select agent literature that is published in this week's issue of the __Proceedings of the National Academy of Sciences__. Casman told __The Scientist__ that her group found, for example, that prior to 2002, an average of 17 papers on anthrax were published for every $1 million of funding, whereas after 2002, that average dropped to 3. At issue, according to the analysis, are two laws designed to regulate select agent research: the linkurl:PATRIOT Act;http://epic.org/privacy/terrorism/hr3162.html and the linkurl:Public Health Security and Bioterrorism Preparedness and Response Act,;http://thomas.loc.gov/cgi-bin/query/z?c107:H.R.3448.ENR: enacted in 2001 and 2002, respectively. The laws' new regulations govern the exhaustive documentation of the transportation, guarding, and use of select agents. As a result, they are burying researchers studying select agents with administrative duties, Casman noted. Researchers to whom Casman spoke "all complained of the paperwork," she said. "A lot of it, they just find overwhelming." Some researchers told Casman that their work took twice as long to carry out because of all the paperwork related to select agents, and that money was being diverted from research expenses to pay for things like security cameras, hiring guards, and building walls. "It's expensive to comply with the regulations," Casman said. "It is getting grossly impossible to do meaningful research," linkurl:Martin Hugh-Jones,;http://www.vetmed.lsu.edu/pbs/hugh-jones.html Professor Emeritus at Louisiana State University and coordinator for the World Health Organization's Working Group on Anthrax Research and Control, told __The Scientist__. "The paperwork now is unbelievable," said Hugh-Jones, who Casman interviewed as part of the study. Casman and her team also found that US labs working on anthrax or Ebola are also collaborating less with labs outside of the US, likely a result of restrictions in the laws. "International collaborations between a US author and a non-US author were inhibited," she said. linkurl:Lisa Hensley,;http://cpol.army.mil/library/news/acp/0710cpom.html virologist and chief of the Viral Therapeutics and Virology Division at the US Army's Research Institute of Infectious Diseases in Maryland, agreed that it is much harder for her to work with foreign labs on projects involving Ebola or any of the other potentially weaponizable pathogens she studies. Also, Hensley told __The Scientist__ that other countries have adopted stringent laws around working with select agents that mirror the US laws and create a "hesitancy by international partners to share viral stock samples with us." For example, Hensley's lab has faced huge obstacles in obtaining a sample of a Crimean-Congo hemorrhagic fever virus that killed a US Army soldier in Afghanistan last year. Hensley said that the soldier was taken to a German research institute for further study after his death, but that samples of the virus have not yet made it to her lab. "We've been trying for nine months to get the isolate shipped to us," she said, adding that the US Army enforces further regulations beyond those codified in the PATRIOT Act and other federal laws. Hensley also noted that in 1998, when she first came to her Army lab, it took her about a month to get clearance to enter the BSL-4 facility, which is the highest security level lab, necessary to house and study Ebola virus. Now with all the background checks and psychological and medical testing required of laboratory workers, she said, "It easily takes close to 6-9 months from the time somebody walks into the door before they have access to a containment lab." And that's just to get into a BSL-3 lab to train to be in a BSL-4 lab. Casman said that the key to increasing the efficiency and reach of select agent research starts with reducing the amount of paperwork required of researchers. For instance, they must record precise volumes of samples and submit those values to authorities -- even when moving droppers of virus or bacteria from one container to another within a lab. "There are certain things that can be done to make the lives of the scientists easier," Casman said. "Making the paperwork less absurd would really help." Hensley, who was also interviewed by Casman as part of the study, said that she marshals on with her work, despite its administrative burden. "We accept all the regulations as the price of doing business, but it does slow down the timeline," she said. "It's just a much different world than it used to be."
**__Related stories:__***linkurl:Biosecurity rules under review;http://www.the-scientist.com/news/display/55821/
[9th July 2009]*linkurl:Security woes halt Army research;http://www.the-scientist.com/blog/display/55407/
[9th February 2009]*linkurl:How to fix biosecurity?;http://www.the-scientist.com/blog/display/55166/
[4th November 2008]

Comments

Avatar of: anonymous poster

anonymous poster

Posts: 17

May 11, 2010

The Select Agent Rule per se is not absurd, but its interpretation by the authorities leaves a lot to be desired. For instance, completely harmless mutants of Select Agents are still covered by the Rule unless express permission is sought to have them removed. To my knowledge no-one has yet succeeded in this endeavor save for a few vaccine strains that pre-dated the Rule. Thus, bugs more harmless than E. coli K12 have to be handled as if they were fully pathogenic BSL3 or BSL4 organisms. A truer case of regulatory overkill would be hard to imagine.
Avatar of: anonymous poster

anonymous poster

Posts: 1

May 11, 2010

One should keep in mind that as the level of funding has climbed, new, inexperienced, and probably unproductive scientists have been dipping into these research funds.
Avatar of: anonymous poster

anonymous poster

Posts: 8

May 11, 2010

Casman and co-workers report a "2- to 5-fold" "loss of efficiency" "as measured by the number of research papers published per millions of US research dollars awarded" in post-9/11 select-agents research and ascribe this to an "increase in the cost of doing select-agents research."\n \nThis interpretation is unsound. \n \nIn principle, a decrease in efficiency can be ascribed to a increase in cost, an decrease in benefit, or both. \n \nIn the case of post-9/11 select-agents research, there has been a massive decrease in benefit..as sub-par, sub-mediocre, select-agents research has been prioritized, funded through set-asides, and funded at unprecedented award levels. The resulting decrease in select-agents research quality--from mediocre under the easy-money environment in effect for select-agents research from FY1992-FY2002 to sub-mediocre under the free-money environment put in effect for select-agents research in FY2003--is more than sufficient to account for the observed decrease in efficiency.
Avatar of: anonymous poster

anonymous poster

Posts: 17

May 11, 2010

Is that you Richard Ebright (anon poster #2)? Regardless, the fact is that most of the incomers to the biodefense research community were scientists who were formerly engaged in other areas of NIH-funded infection and immunity work. Biodefense work didn't make them sub-mediocre. Therefore, the worst case scenario is that NIH funded deadbeats were moved from one endeavor to another.\n\nAdditionally, you are dreaming if you think that the billions of extra new dollars allocated to biodefense would otherwise have been added to the general NIH budget. If anything biodefense was an early ARRA program that extended a lifeline to scientists that were struggling to get funded from the much smaller regular NIH pot.
Avatar of: anonymous poster

anonymous poster

Posts: 1

May 12, 2010

Another issue is that journals are asked to self-police what gets published, after an uproar about a publication of recombinant poxvirus that expressed IL-4 a few years ago. How much work has been done only to have it rejected based on fear and uncertainty by the journal review boards?

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