The Sunshine Project
News Release
21 October 2003

Biosafety Irregularity in Spanish Flu Experiments
Highlights the Need to Strengthen Biodefense Transparency

(Austin and Hamburg) - Genetic experiments to recreate one of the most devastating viruses of the past century were not reviewed or approved by a biosafety committee. The University of Georgia claims that it was too troublesome to convene its Institutional Biosafety Committee to review research to genetically reconstruct the Spanish flu. Instead, the University signed off on the experiments based on ad hoc talks between only four members of its biosafety committee. As a result, no minutes were taken to describe safety review of the experiments. In fact, by not convening its committee, Georgia's actions ensured that there was no timely opportunity to raise concerns at all.

The case demonstrates a severe weakness in the public disclosure provisions of federal research rules (the NIH Guidelines) and underscores the need for mandatory committee-level (or higher) review of research projects with disease agents. By approving the experiments with an ad hoc subcommittee, requirements for public disclosure were avoided. The existence of the experiments only came to light through journal articles. According to Edward Hammond of the Sunshine Project, "Genetic engineering of bioweapons agents has national and international implications for health, biosafety, and security. But Georgia shied away from these and simply rubber-stamped the Pentagon-led project to recreate the Spanish flu."

More stringent, more public review is required, says Hammond, "Weighing the merits and hazards of these kinds of experiments requires open discussion. Georgia's claim that reconstituting Spanish flu doesn't merit a biosafety committee meeting is scandalous, and will diminish public trust in the biosafety committee system."

In 1918-19, the Spanish flu killed 20-40 million people worldwide. In the US, deaths from the flu strain resulted in a 10 year drop in life expectancy. Recreating the deadly flu may create international unease, in particular because of the leadership of the US military in the project. The experiments were described by the Sunshine Project on October 9th. (See News Release "Lethal Virus from 1918 Genetically Reconstructed" and the briefing paper "Recreating the Spanish flu?", both available online.)

The Spanish flu reconstruction began at a University of Georgia biosafety level three (BSL-3) facility in 1999. Researchers from US universities, the Armed Forces Institute of Pathology, and the US Department of Agriculture (USDA) are involved. The lab specializes in diseases of poultry, including avian influenza. The Sunshine Project has confirmed - and reconfirmed - under the Freedom of Information Act that USDA has no biosafety committee minutes related to the experiments. The Project also directly contacted the University of Georgia and requested Institutional Biosafety Committee meeting minutes that are required by the NIH Guidelines for Recombinant DNA Research. Georgia's Biosafety Officer stated that no minutes exist.

Scientists have recently begun to accept the need to reinforce the Institutional Biosafety Committee system established under the NIH Guidelines for Recombinant DNA Research. But the discussion, including that in a recent report on biosafety by the National Academies of Science, is out of balance because it is taking place almostly exclusively between scientists, government regulators, and the Pentagon. "There is a need to make more room at the table. The public has a right to help determine if, and under what conditions, risky research proceeds." says Hammond, "Biosafety review must be a matter of law, and public access provisions of federal research rules must be strengthened. Otherwise, risky experiments such as this one will take place with little or no transparency, and that will decrease international security and create environmental and health risks."

A Sunshine Project briefing paper on the 'Reconstruction of the Spanish influenza virus' provides further details and a comprehensive literature list.