By Andrew D. Thibedeau
Biowarfare maskIn response to the 2001 terrorist attacks, Congress passed the USA PATRIOT Act of 2001 "[t]o deter and punish terrorist acts in the United States and around the world [and] to enhance law enforcement investigatory tools."1 Shortly thereafter, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 "[t]o improve the ability of the United States to prevent, prepare for, and respond to bioterrorism."2 In the current issue of the Proceedings of the National Academy of Sciences, M. Beatrice Dias of Carnegie Mellon University and colleagues report the findings of a study conducted to gauge the impact of these laws on bioterrorism research.3 

The study focuses on research trends in so-called "select agents" research. Select agents are pathogens and toxins listed by the US government that pose a severe threat to public health and safety.  They include smallpox, anthrax, botulin toxin, the 1918 flu virus, Ebola, Ricin, and plague.4 Looking for patterns in anthrax and Ebola research publications, the study reveals many shocking findings. "The most striking observation," Dias et al. observe, "is a significant increase in the role of the military laboratories in 'live-pathogen' select agent research and the relative decline in the centrality of the civilian government laboratories."5 Nevertheless, at the same time, "research became less efficient."6 Prior to 2002, for every $1 million of research funding, seventeen papers on anthrax were produced. After the passage of the USA Patriot Act and the Bioterrorism Preparedness Act, the average fell to three per $1 million. The study finds as much as a fivefold loss in research efficiency.7

The authors reveal other disquieting trends in the biodefense field.  Contrary to lawmakers' intent, research "[n]etwork centralization decreased over the study period for 'live-pathogen' research" on both Ebola and anthrax.  In other words, the number of researchers and research institutions working on these lethal pathogens grew significantly.  This has translated to a proliferation of new biodefense laboratories across the nation.  At the same time, senior scientists have begun leaving the field in significant numbers. Though researchers interviewed for the study remarked that "the increased US funding led to an influx of new scientists," many did not stay for long.  What's more, given the inherently international nature of the biosecurity threat, it is troubling that the study also observes "a pattern of decline" in international collaboration on biosecurity research.  Taken together, the proliferation of new biohazard facilities, the influx of new, less-experienced personnel, and the decline in international cooperation begs the question: are we safer?

Finally, and most problematic, the scientists that were interviewed repeatedly pointed to the supposed administrative burden that government regulation placed on their research as the primary cause animating these trends.  "Nearly all authors complained of the increased paperwork that they were legally obligated to fill out," the study reports, "one of them estimating that it took twice as long to do any project as a direct result of the bureaucratic overhead."  When questioned, another researcher lamented that "the FBI background checks took so long that they interfered with hiring students and technicians, especially non-US citizens."  Rules restricting laboratory access and the transport of deadly organisms are cited as making "the process of collaborating . . . significantly slower and more tedious."  In 1998, it took about a month to obtain clearance to work in a BSL-4 facility.  Now, owing to "all the background checks and psychological and medical testing . . .[i]t easily takes close to 6-9 months."8

This view is strikingly at odds with those held outside the biodefense establishment.  As Beth Willis writes in her article The Lab in My Backyard: "[l]abs certainly need better regulation and oversight to ensure adequate safety." In A Cruel and Unusual Corporation, Ralph Nader expresses outrage that OSHA "has been without any regulations or disclosure requirements about biohazards in laboratories." Perhaps David Bell's shocking ailment would have been averted, Sam Anderson speculates in Teatime in the Lab, "had there been any federal regulatory oversight" or if OSHA had made a timely visit to AgraQuest's "slipshod" laboratory. 

In the last analysis, the study's findings point to one inescapable conclusion: neither the USA PATRIOT Act nor the Bioterrorism Preparedness Act has improved our ability to prevent, prepare for, and respond to bioterrorism.  Instead, they have helped to create an over-funded and under-regulated biodefense community that appears utterly oblivious to the grave risk it poses to the public health.  It is thus somehow fitting that the special agents list also includes tularemia, or rabbit fever-for it is only down a rabbit hole in the Alice-in-Wonderland world of U.S. biodefense that billions of dollars and regulatory absenteeism could breed such a deadly combination of lethal pathogens and willful incompetence.

Andrew Thibedeau is a Fellow of the Council for Responsible Genetics.


1. Pub. L. 107-56, 115 Stat. 272 (2001).
2 Pub. L. 107-188, 116 Stat. 594 (2002).
3.  M. Beatrice Diasa, Leonardo Reyes-Gonzaleza, Francisco M. Velosoa,b, & Elizabeth A. Casmana, Effects of the USA PATRIOT Act and the 2002 Bioterrorism Preparedness Act on select agent research in the United States, Proceedings of the National Academy of Sciences 107, no. 21, p. 9556 to 9561 (May 25, 2005).
4.  42 C.F.R. §§ 73.3, 73.4 (2009); see also (National Select Agents Registry Program).
5. Dias et al. 9558.
6. Dias et al. 9560.
7. Dias et al. 9557.
8. Bob Grant, Biosecurity Laws Hobble Research, NewsBlog (May 10, 2010).

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