SPECIAL REPORT: America's Broken Biodefense Strategy
According to the NIAID there are four BSL-4 locations in the United States: At the Centers for Disease Control and Prevention in Atlanta; at the United States Army Medical Research Institute for Infectious Diseases at Fort Detrick in Frederick, MD; at the Southwest Foundation for Biomedical Research in San Antonio; and at the University of Texas at Galveston. But are such facilities really safe? Not at the moment, as a closer look unveils – and maybe the reason for the clear message coming from the NIAID: “Recent natural and bioterrorist events involving infectious agents have made it very clear that from a strategic national perspective, a serious shortage of BSL-3 and BSL-4 laboratory space exists”. America will have to reshape its biodefense strategy. by Vlad Georgescu
The problem, which is neither new nor unknown, has been “well documented by the Institute of Medicine, and it has repeatedly been identified in NIAID's strategic planning process”, as the experts are explaining on their online site. “Thus, NIAID's research agenda for biodefense and emerging infectious diseases includes plans to construct and renovate BSL-3 and BSL-4 laboratories around the country”.
For President Barack Obama, who had to realize that even his best agencies failed in preventing terrorist attacks like the latest, almost successful one in Detroit, fighting the existing bioterrorism risk will rise to a crucial challenge. If agents couldn’t prevent a terrorist from boarding a plane – how should they stop the expected bioterrorist attacks?
USA: Deadly viruses out of control
The situation seems to be critical, as U.S. Government Accountability Office (GAO) chief technologist Keith Rhodes from the Center for Technology and Engineering, Applied Research and Methods 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. Rhodes explained that high-containment biosafety laboratories, specifically biosafety levels 3 and 4 (BSL-3 and BSL-4), had been “proliferating” since the September 11, 2001 terrorist attacks. The report was 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 described in late 2007 exceeds the worst imagination of today: “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.
The security lacks may also come from inside – by coincidence, as another example shows. 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. As long as such security lacks in governmental or private virological chains persist, America will remain under bioterrorist threat.
The DHS will have to analyze and reshape the countries biodefense strategy – otherwise 9/11 could become the minor terrorist attack in America's recent history.
LifeGen.de LTD is now ready for the friendly take over by private, governmental or corporate investors. Contact CEO VLAD GEORGESCU, vg@lifegen.de
(2010-08-02)
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