Is the United States close to violating the Biological and Toxin Weapons Convention (BWC)? At thefifth annual American Society of Microbiology (ASM) Biodefense Conference in Washington, D.C., in February, Bernard C. Courtney, scientific director of the Department of Homeland Security's National Biodefense Analysis & Countermeasures Center, described how the U.S. government is building a network of laboratories to characterize and anticipate future biothreats, as well as conduct biological risk assessments. Research at some of these laboratories should be cause for concern to all.
One of these laboratories is the Lawrence Livermore National Laboratory in California. It will house the new Biological Threat Characterization Center. This is the same laboratory that was just given a federal award to design the nation's first new nuclear weapon in two decades. Livermore has been doing bioscience research since 1963, but its initial mission was to characterize the biological consequences of ionizing radiation. Since then, its research scope has expanded dramatically, and it is now embarking in an area of biological research that was not clearly articulated in Courtney's talk. This vagueness is not new. A 2002 editorial in the Daily Californian also expressed concern about the kind of biothreat research Livermore will conduct.
In addition to Livermore, Homeland Security is also building a large National Biological Weapons Analysis Center facility on the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) campus at Fort Detrick in Maryland. Courtney mentioned that this facility will conduct some classified research. Officially, the United States has not done any classified biological research since it terminated its offensive biological weapons program in 1969. However, in their book Germs, New York Times reporters Judith Miller, Stephen Engelberg, and William Broad uncovered "biodefense" research conducted by the CIA and Pentagon that arguably pushed the BWC's boundary limits.
Now, the United States will be doing classified research under the auspices of Homeland Security. The mission is to provide the nation with the scientific basis for awareness of biological threats and attribution of use against the U.S. public. Courtney assured the audience that the research will not violate the BWC because a "Compliance Review Group" composed of senior Homeland Security officials will oversee the research. The majority of them will be lawyers and scientists.
One could argue that the composition of this committee would not meet muster with any local Institutional Biosafety Committee. Where are the ethicists? What about outside representation? Will the minutes be available under the Freedom of Information Act?
The core issue is whether Homeland Security should be in charge of biodefense research in the first place. It is a new, very large, unwieldy agency that hasn't had a long track record to instill confidence. Created after 9/11, Homeland Security is the third largest cabinet department in the U.S. federal government. Its mission is to prevent and deter terrorist attacks and protect against and respond to threats and hazards to the nation. But one could argue that some of its efforts to accomplish this mission, particularly in the area of biological threat assessment, are as bad as any outside threats. (Jonathan Tucker discussed some of these dilemmas in an October 2004 Arms Control Today article entitled, "Biological Threat Assessment: Is the Cure Worse Than the Disease?"
It is important to note, however, that it is not just Homeland Security that's embarking on research of questionable ethics and merit. In a subsequent session at the ASM conference, Peter Jahrling, a researcher at the Integrated Research Facility at the National Institutes of Health/National Institute of Allergy and Infectious Diseases and a former researcher at USAMRIID, presented his work on developing an animal model for smallpox. This work is not classified and has been profiled in the March 15, 2002 Science by Martin Enserink and Richard Stone in an article entitled, "Dead Virus Walking."
In a high containment biosafety level 4 laboratory, Jahrling and his colleagues have been infecting monkeys, specifically cynomolgus macaques, with smallpox via aerosol and/or intravenous routes. The monkeys were resistant to the aerosolized version of the virus but succumbed to high viral titers that were intravenously injected. Jahrling showed graphic pictures of monkeys covered in smallpox pustules. Similar research is also being done at Russia's State Research Center of Virology and Biotechnology. China and other nations are understandably concerned about the U.S. and Russian monopoly on this virus.
The purpose of this research is unclear. Terrorists would likely seek to expose humans by aerosolization, not intravenously. Smallpox was eradicated because there was no animal reservoir. Therefore, no animal model could accurately represent a human infection. So why is this research being done on animals?
The Food and Drug Administration's (FDA) "animal rule" is partly to blame. In May 2002, the FDA published "Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible." This rule is known as the animal rule because it amends the new drug and biological product regulations to provide evidence of the efficacy of a new drug against bioterrorism agents on animals as a substitute for human studies. But with a virus such as smallpox, the animal rule doesn't work because smallpox never infected animals in nature.
After two centuries of using the cowpox vaccine--an approach with some dangers--it was efficacious and safe enough to eradicate the disease from human populations. Trying to force smallpox infections into animals is unethical and dangerous; one could argue that it pushes the boundaries of meeting the criteria of one of the experiments of concern in the National Academy of Sciences report by trying to expand the host range of a deadly pathogen. Instead, biodefense research should be done on making the cowpox vaccine safer.
Aside from the questionable utility and ethics of this research, laboratory accidents and inadvertent laboratory-acquired infections do occur even in high containment laboratories. Research on smallpox should simply not be done. (See my paper on biodefense research secrecy and safety.)
Where is the media in all of this, and where is the public debate? Unfortunately, the U.S. media focuses more attention on Anna Nicole Smith's death than on what the federal government is doing in the name of fighting terrorism. Is this federal research agenda under the Bush administration the biological equivalent of its misadventure in Iraq? As with the misinformation over Iraq and the hype leading up to the war, the media is dropping the ball on this issue. The public must be informed.