Monday, April 18, 2005

Faulty Aerosol Chamber Infects Three

The Sunshine Project
New Release - 18 April 2005
http://www.sunshine-project.org

Faulty Aerosol Chamber Infects Three
NIAID Encourages Use of Leaky Device in BiodefenseChambers are Located in Nine US States, India, New Zealand, and Northern Ireland

(Austin, 18 April 2005) - A leaky aerosol chamber manufactured by the University of Wisconsin at Madison was responsible for three laboratory-acquired tuberculosis infections in a Seattle BSL-3 lab last year. The infections have not been made public until now. Nearly twenty Madison chambers exist across the US and in India, New Zealand, and Northern Ireland. While tuberculosis is not a biological weapons agent, the accident underscores the inherent dangers when working with dangerous disease agents, and the grave safety risks of the US biodefense program, which is encouraging more scientists to deliberately aerosolize bioweapons agents in Madison chambers and similar equipment.

The Madison chamber incident is the latest to be reported in a series of US lab accidents, including infections and/or mishandling of anthrax, tularemia, and pandemic influenza. At the encouragement of the National Institutes of Health (NIH), Madison chambers have been purchased for use in Massachusetts, Connecticut, New York, North Carolina, Georgia, Texas, Colorado, Wisconsin, and California, as well as India, Northern Ireland, and New Zealand. More of the suspect chambers may be in use; but the legal counsel of the University of Wisconsin at Madison has refused to answer questions and has been reluctant to promptly answer requests filed under Wisconsin open records law.

The Chamber: The Madison aerosol chamber is a specialized type of lab equipment. The chamber is used to infect animals with disease through their lungs. Cultures of organisms causing tuberculosis or the bioweapons agents anthrax, Q fever, or brucella and others are placed in a part of the device called a nebulizer, which mixes the agents with air. The resulting aerosol is directed into a metal chamber in which animals have been placed on racks. The animals then breathe in the agent. The integrity of the complicated device's "O rings", seals, and other fittings is critical to preventing the aerosols from escaping the chamber and causing accidental infections. But the Madison chamber in Seattle, Washington leaks badly, and in 2004 it caused three laboratory-acquired tuberculosis infections at a BSL-3 lab shared by Corixa Corporation and the Infectious Disease Research Institute (IRDI).

"Foolproof": In late 2003, the Seattle lab began using a Madison aerosol chamber to infect guinea pigs with tuberculosis. Several batches were exposed over a period of months. By March 2004, a serious problem was detected when three employees, who previously tested negative for tuberculosis, came back with positive tests, or "conversions", indicating that they had been exposed to the agent.

The State of Washington opened an investigation. The State's report was obtained by the Sunshine Project and is available at our website. According to the report, in 2003 the IDRI team was trained to use the chamber by its inventor, a professor at Texas A&M University. IDRI was also trained by representatives of the University of Wisconsin at Madison. According to the State of Washington's investigation, Dr. David McMurray, the inventor and a tuberculosis researcher, made audacious safety claims about the chamber. The report says that McMurray claimed that "the chamber was so safe that there was no need to even locate it in a BSL-3 environment", that it was "foolproof", and that "respirator use was not necessary".

The Leaks: Interviews with IDRI staff by state investigators revealed that a leaky airflow meter was probably responsible for the infections. The investigation also revealed that IDRI staff had repeatedly encountered other dangerous problems. The chamber operator told state investigators "the Chamber seals deteriorate quickly, crack and last about a month" and in June 2004, well after the first problems were thought to be fixed, "another big leak was recently found." Another researcher said "several seals of the Chamber were found to be cracked". IDRI does not conduct biodefense research.

Leak Replicated, No Apparent Safety Advisory: The airflow meter also leaked in tests of a Madison chamber located in Fort Collins, Colorado. Although the University of Wisconsin at Madison was contacted by the State of Washington in the course of the investigation, two Madison aerosol chamber customers contacted by the Sunshine Project say that they have not received any safety advisories. Nor has the chamber's manual been changed in response to the State's findings. The current manual, obtained by the Sunshine Project under Wisconsin open records law, is dated 22 April 2002.

Biodefense Use: Many Madison chambers are used for tuberculosis studies; but others are used for biodefense. In December 2003, the Madison chamber was presented at a National Institute of Allergy and Infectious Disease (NIAID) biodefense workshop. Biodefense use includes: At Texas A&M University, scientists are using it to aerosolize brucella and Q fever. At the University of Texas Medical Branch at Galveston, it is used by an anthrax researcher funded by the Department of Defense and NIAID. With NIAID encouragement, other biodefense projects using the Madison chamber are likely planned or even underway.

Known Madison Aerosol Chambers and Locations*
---------------------------------------------
University of California San Francisco, CA
Corixa / Colorado State Univ. Fort Collins, CO
Yale University New Haven, CT
University of North Carolina Chapel Hill, NC
University of Georgia Athens, GA
Harvard University Cambridge, MA (possibly 2 chambers)
Corixa / IDRI Seattle, WA
HHMI / Albert Einstein Univ. Bronx, NY
Rockefeller University New York, NY
University of Texas HSC San Antonio, TX
Univ. of Texas Medical Branch Galveston, TX
University of Texas HSC Tyler, TX
Texas A&M University College Station, TX (possibly 2 chambers)
University of Wisconsin Madison, WI (presumed)
Queens University Belfast, N. Ireland
Astra Zeneca Bangalore, India
AgResearch Wallaceville Upper Hutt, New Zealand
*Some chambers may not yet be delivered. Source: Open Records requests to the University of Wisconsin at Madison, and "Pulmonary Delivery of Mycobacteria and Other Respiratory Pathogens to Small Animals in a Specially-Designed Aerosol Chamber", presentation to the NIAID Workshop "Aerosol Challenge Technology and Applications in Biodefense", Bethesda, 3 December 2003, URL: http://www2.niaid.nih.gov/Biodefense/Research/AEROSOL/davemcmurray.htm

Conclusions: The Sunshine Project has been calling attention to the safety and security dangers of the US biodefense program since 2000. This case underscores how the 'precise, clean and neat' public image of BSL-3 and BSL-4 facilities that is promoted by NIAID and labs is frequently at odds with messy and risky realities.

According to the Sunshine Project's Edward Hammond, "It should not fall to a small non-profit to reveal incidents such as this one. In this case, the institutions involved apparently didn't even inform their peers about the problems. Public safety and an informed debate about the biodefense program require the government to mandate public disclosure of all significant lab accidents. This may be more cold water on overheated biodefense safety claims; but we frankly wonder how many more serious problems have been kept out of the public eye."

The United States does not have comprehensive laboratory safety law. The Madison chamber failure and consequent lab-acquired infections are yet more evidence of the urgent need for binding laboratory biosafety law, backed by enforceable international standards.
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"Dr. Spencer Wells, a population geneticist at the [National Geographic] society who is leading the program, said he hoped to head off charges of exploitation by offering money to the tribes for education and cultural preservation." - New York Times on HGDP: Reloaded, 13 April 2005
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