H5N1 out of control: Labs under bioterrorist and pandemic threat
The book is scheduled for April 2009, but the Baxter-Contamination-Case in Europe may justify how necessary the reading really will be. “Detection of Highly Dangerous Pathogens: Microarray Methods for BSL 3 and BSL 4 Agents” (WILEY, ISBN: 978-3-527-32275-6) is written by leading experts in the field as part of an interdisciplinary pan-European research program funded by the EU. According to Wiley, “this book provides a unique and comprehensive overview of how microarray technology can be used in safely tracking the most highly dangerous pathogens”, and: “A must-have for public health agencies focused on bioterrorism as well as all laboratories working with BSL3 and/or BSL 4 agents”. The publishing house is right, as a U.S. Government Accountability Office (GAO) preliminary Report revealed already in 2007: “No single federal agency, according to 12 agencies' responses to our survey, has the mission to track the overall number of BSL-3 and BSL-4 labs in the United States”. Another Report to the Chairman, Committee on Homeland Security, House of Representatives, issued on February 26th this year resumes the worst case: “Although certain performance measures have been established in the National Pandemic Implementation Plan to prepare for an influenza pandemic, these measures are not always linked to results”. The Baxter H5N1 Contamination in Europe was not the first global viral accident in BSL labs, as governmental documents from 2007 reveal. by Vlad Georgescu
Highly pathogenic virus-samples are sen t around the globe by many pharmaceutical and biotech companies. They work with lethal viruses, and many of these labs have subcontractors which can't secure the deadly stuff in an appropriate way. And, worst of all, security lacks could initiate a new bioterrorist threat coming from inside western countries – not because of Baxter, but because it became evident that samples can be out of routine control even if belonging to pharmaceutical giants working very professional - usually.
But as our coverage of the Baxter-Contamination Story in Europe on February 26th 2009 revealed, there are massive security lacks among the routines, even if Baxter is denying that fact. Jutta Brenn-Vogt, Manager Communications at Baxter Deutschland GmbH explained LifeGen.de what happened with H5N1: "Causes were a unique combination of process, technical and human errors". US and European officials should be worried about another statement made by Baxter in Germany: “As this material was not produced for human use, testing for potential contamination is not routinely carried out”.
This may lead to the question why one of the biggest pharmaceutical companies doesn’t consider routine testing for all samples as a crucial security measure – and how samples declared as for non-human use are controlled at all.Financial investors did understand the risk of such details. Shares of the big pharmaceutical company in Deerfield, IL, lost more than 8 percent in only two days after LifeGen.de started to report about the H5N1 Contamination in Europe. Before, PROMED and Bloomberg mentioned the story, but obviously with far less response on a global scale, as a look at the charts from February 26th at Google Finance reveals.
No wonder Baxter's Chief of Communications in the US, Christopher Bona, supported our idea for an exclusive interview, and so we got the information explaining what happened in Europe.
But after the Baxter H5N1 disaster in Europe (read our exclusive Interview) there was another alarming news arising on the horizon. New research from the CDC, reported in JAMA, found that one strain of the influenza is becoming increasingly resistant to the frequently prescribed medicine oseltamivir. During the 2007-2008 flu season, the CDC found that 12.6% of the influenza A H1N1 viruses tested were resistant to oseltamivir. During the current season, approximately 98.5%, of influenza A (H1N1) viruses tested (to date) were resistant to oseltamivir. Such statistics are considered important as pandemic avian influenza could be on its way to conquer the world - and a mixture between avian and human strains would result in the long expected virological disaster. Under such circumstances, every uncontrolled sample reaching unknown laboratory places could be the igniting factor. Cross contaminations between different influenza strain seem to be possible, even if carried out by error. Or by bioterrorist attack.
USA: Deadly viruses out of control
U.S. Government Accountability Office (GAO) chief technologist Keith Rhodes from the Center for Technology and Engineering, Applied Research and Methods, GAO noted in late 2007 in his written testimony before the U.S. House of Representatives Subcommittee on Oversight and Investigations, Committee on Energy and Commerce that high-containment biosafety laboratories, specifically biosafety levels 3 and 4 (BSL-3 and BSL-4), have been “proliferating” since the September 11, 2001 terrorist attacks. The report is alarming, as the following excerpt demonstrates:
“A major proliferation of high-containment BSL-3 and BSL-4 labs is taking place in the United States, according to the literature, federal agency officials, and experts. The expansion is taking place across many sectors--federal, academic, state, and private--and all over the United States. Concerning BSL-4 labs, which handle the most dangerous agents, the number of these labs has increased from 5--before the terrorist attacks of 2001--to 15, including at least 1 in planning stage. Information on expansion is available about high-containment labs that are registered with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture's (USDA) Select Agent Program, and that are federally funded. However, much less is known about the expansion of labs outside the Select Agent Program, as well as the nonfederally funded labs, including location, activities, and ownership. No single federal agency, according to 12 agencies' responses to our survey, has the mission to track the overall number of BSL-3 and BSL-4 labs in the United States”.
BSL-3 and BSL-4 mostly contain very hazardous biological agents, potentially to be used as bioweapons, as bacteria, viruses, fungi, and other microorganisms. The labs also can contain infectious substance which have been bioengineered or synthesized from special component of microorganism. For example, BSL-4 laboratories are working with small pox viruses (Variola major) or the plague virus (Yersinia pestis).
Labs as unknown puzzle
What Rhodes is describing exceeds the worst imagination: “Though several agencies have a need to know, no one agency knows the number and location of these labs in the United States. Consequently, no agency is responsible for determining the risks associated with the proliferation of these labs”
Rhodes and his team identified “six lessons from three recent incidents: failure to report to CDC exposures to select agents by Texas A&M University (TAMU); power outage at the CDC's new BSL-4 lab in Atlanta, Georgia; and release of foot-and-mouth disease virus at Pirbright in the United Kingdom”. The Baxter case in Europe this year seems to be only one part of the big, unknown virological puzzle.
According to Rhodes such “lessons highlight the importance of identifying and overcoming barriers to reporting in order to enhance biosafety through shared learning from mistakes and to assure the public that accidents are examined and contained; training lab staff in general biosafety, as well as in specific agents being used in the labs to ensure maximum protection”.
Rhodes suggested in 2007 to develop “mechanisms for informing medical providers about all the agents that lab staff work with to ensure quick diagnosis and effective treatment”. However, before 1990, all BSL-4 labs were federal labs, as the report explains, either at USAMRIID or at the CDC. These were the good times. Today many of the BSL-4 labs are at universities and in the private sector. 143 BSL3 labs belong to the private sector, 487 are academic and 458 are said to be federal owned.
The huge number is alarming, because even military labs could be under terrorist threat, as the anthrax mailings from 2001 show.
The 2001 anthrax attacks known as Amerithrax from its Federal Bureau of Investigation (FBI) case name, started on September 18, 2001. Media offices and two Democratic U.S. Senators,received letters containing anthrax spores, five people died, 17 were infected. Last year the FBI narrowed its focus to Bruce Edwards Ivins, a scientist who worked at the government's biodefense labs at Fort Detrick in Frederick, Maryland. But Ivins, who had had been told about the impending prosecution, died from an overdose of "Tylenol with Codeine," which was reported as a suicide on August 1, 2008. On August 6, 2008, federal prosecutors declared Ivins to be the sole culprit of the crime. The British magazine New Scientist published last week an article explaining from a microbiological point of view why Ivins may not be the sole culprit – security lacks and information gaps in one of Americas best protected biodefense labs seem to be part of this puzzle.
Not fully prepared for the worst case
Finally, the Baxter H5N1 Contamination Case in Europe sheds light on all these aspects. Unknown labs, unknown research, unknown attacks and accidents happen since years, and compared with the past baxter was only one more statistic among the unknown data. But why should we worried? A new GAO report titled “Influenza Pandemic: Sustaining Focus on the Nation's Planning and Preparedness Efforts” and released on February 26th this year explains what the real problem – not only for the US – may be: “Although certain performance measures have been established in the National Pandemic Implementation Plan to prepare for an influenza pandemic, these measures are not always linked to results”, and: “Nevertheless, an influenza pandemic remains a real threat to our nation and the world”. Even if the expected influenza pandemic did not start yet, there is no doubt about the comeback of the lethal virus: The first Pandemic Influenza occurred in three waves in the United States - exactly 90 years ago, between 1918 and 1919.
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