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Company Mum on Details of Flu Virus Mishap

The details of a potentially dangerous virus contamination that affected research labs in four European countries may remain shrouded in mystery. While acknowledging responsibility for the mix-up, health care company Baxter says it will not reveal the exact chain of events that led the unsuspecting labs to receive H5N1, the highly lethal avian influenza virus, in samples of less dangerous flu strains.

In early February, a Baxter facility in Austria sent an Austrian research company, Avir Green Hills Biotechnology, samples of the human flu strain H3N2 that were contaminated with H5N1. Avir Green Hills sent the material on to subcontractors in the Czech Republic, Germany, and Slovenia. It wasn't until ferrets exposed to the samples started dying in the Czech lab that the mistake was discovered; H3N2 wouldn’t normally kill the animals. Although a few press stories emerged in late February, the affair has received little media attention in Europe.

Scientists and workers at all four labs have been tested, and none have become infected with H5N1, says Christopher Bona, director of global bioscience communications at Baxter's headquarters in Deerfield, Illinois. Baxter has helped sanitize the labs, and the virus samples have been destroyed, he adds. The company has cooperated with an audit by the Austrian government and has taken measures to prevent the incident from happening again, Bona says—but he declines to explain what happened at the Baxter facility in Orth/Donau, where the contamination occurred. "It was a unique combination of process, technical, and human errors," Bona says, adding that further details would reveal proprietary information about Baxter's procedures. The Orth/Donau facility is a research lab, he notes, and is not involved in the production of Baxter's candidate H5N1 vaccine, which is made in the Czech Republic and is awaiting approval by European regulators.

A spokesperson for the Austrian health ministry confirms that the audit took place but says that "nothing interesting or alarming was found" and that the government won't reveal further details. "As Baxter announced, it was a combination of technical and human errors. Because of data privacy, we are not allowed to speak about the details," she wrote in an e-mail to ScienceInsider.

The affair's cross-border dimension has created concern among European public health officials and has triggered a debate about the need for firmer biosafety rules within the European Union, says one public health scientist familiar with those discussions. But European countries have always fiercely defended their independence in public health matters, leaving the E.U. rather toothless. The European Commission has followed the affair closely, but contamination is an issue for national health authorities, says the commission's spokesperson for health. The E.U.'s disease watchdog, the European Centre for Disease Prevention and Control (ECDC) in Stockholm, says it has also been "in close contact with the member states, [the World Health Organization], and the European Commission" about the affair. But ECDC has no formal authority to investigate, either.

But shouldn’t Baxter have to more fully and publicly explain what happened so that Europeans have some assurance that the mistake won't be repeated? No, says Bona. "I think I just explained what happened in great detail," he insisted to ScienceInsider. "It was a unique combination of process, technical, and human errors."