Are We Ready for a Biological Attack?

There has been much discussion by national security experts inside and outside of government as to how Congress and the president should ensure that the United States is safe from a terrorist attack. But there has been relatively little discussion in comparison as to how we would respond if an attack did occur. Are we ready for a biological attack on our military or citizenry? Are we spending money on the right therapies? Do we even know how to respond to a widespread biological or chemical attack on the United States or our allies?

The National Intelligence Council (NIC) has identified the threat of bioterrorism as the most significant weapon of mass destruction (WMD) concern as the knowledge, equipment, and pathogen components required to construct biological weapons are now globally dispersed. There is currently no single strategy to regulate or prevent the development of these threats. Immense spending by U.S. government agencies to advance single-target drug and vaccine countermeasures against known bioterror threats has produced limited results and highlights an urgent need for new defensive therapeutic strategies.

In response to these very real threats and the subsequent billions of dollars in spending, the Obama administration has announced a new biodefense plan that will fund "platform technologies" that apply to many different infectious disease threats. The Department of Health and Human Services (HHS), which oversees all U.S. health agencies, has decreed that broad-spectrum therapies able to combat multiple pathogen threats will be the focal point of biodefense initiatives going forward. Additionally, HHS has disclosed that it will discontinue policies that previously precluded support of dual-use therapies that may have commercial applications against disease conditions such as hepatitis-C virus (HCV) or cancer. Homeland Security Newswire reports the FY2011 budget calls for $6.48 billion in biodefense spending, which reconfirms the growing concern of bioterrorism and reinforces the opportunity for organizations with novel treatment strategies that augment or overcome the limitations of single-target drug and vaccine strategies.

Our response to these new policy initiatives has been to reestablish efforts to advance a Hemopurifier platform technology as a broad-spectrum treatment countermeasure against bioterror threats. A Hemopurifier is a first-in-class medical device that selectively targets the removal of infectious viruses from the entire circulatory system before the occurrence of cell and organ infection. The device also addresses a previously unmet medical need by clearing immunosuppressive proteins that shed from viruses to trigger apoptosis of immune cells needed to combat infection. While our primary focus will continue to be advancing a Hemopurifier as an adjunct therapy in HCV care, we believe a Hemopurifier may be the most advanced and perhaps only true broad-spectrum countermeasure against viral threats most likely to be weaponized against civilian and military populations. This belief is supported by human clinical outcomes and supporting in vitro studies conducted at leading government and nongovernment labs.

Single-target drug and vaccine strategies are clinically and economically problematic. There are just too many threats and too many possible drug therapies to keep up. The benefit of drug and vaccine countermeasures stockpiled by the U.S. government is also not fully understood. Vaccine countermeasures procured into the SNS expire every few years and need to be replenished. Additionally, the initial purchase of a single-target countermeasure alone can exceed $1 billion and there is no guarantee that once a vaccine is developed that it would not then develop a resistance to the drug. We simply do not have enough money or researchers available to keep up with the many options that a biological attack would produce.

A Hemopurifier provides a post-exposure treatment strategy to mitigate illness, suffering, and death resulting from exposure to viral pathogens, including biological weapons. The device is a highly developed broad-spectrum treatment platform as evidenced by human clinical outcomes and in vitro studies conducted at leading government and non-government labs. A hemopurifier provides rapid clearance of viral pathogens and immunosuppressive proteins resulting in an antiviral and immunotherapeutic mechanism to improve the benefit of stockpiled countermeasures whose effectiveness in humans is unknown. The device also provides a countermeasure against viral threats not addressed by drug and vaccine therapies and diminishes challenges in addressing genetically modified. The device removes and concentrates viruses from the entire circulatory system and also offers to assist with early pathogen diagnosis and provides a unique strategy for treatment in advance of pathogen identification. To date, safety of the device has been demonstrated in 68 human treatment experiences, which also validated the ability of the device to reduce viral load in patients infected with HCV and HIV in the absence of drug therapy benefit. To initiate treatment with a Hemopurifier, blood circulation is established into the filtration device via a catheter or a veno-venous stick identical to that used in standard blood collection procedures for cell separation. Once blood flow has been established and directed through a Hemopurifier, infectious viruses and immunosuppressive proteins are selectively captured from circulation prior to the occurrence of cell and organ infection.

Collaboration has been done with The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) located at Fort Detrick, Maryland; The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV), a leading infectious disease research center in India collaborating with the World Health Organization (WHO); The Battelle Biomedical Research Center (BBRC), one of the largest, private, biomedical laboratories in the U.S.; and The Southwest Foundation for Biomedical Research (SFBR). A Hemopurifier holds promise to be an integral post-exposure treatment strategy to mitigate illness, suffering, and death resulting from exposure to biological weapons. The highest priority for Congress and the President should be to develop defense programs that can guard against a terrorist attack ever happening. But should we find ourselves in the terrible position of having to respond to a biological attack, the unprecedented broad-spectrum capabilities of a Hemopurifier is one solution that could be used to treat victims in the United States and ally nations.