Anthrax. Ebola. Smallpox. These are just a few of the biological agents that could be weaponized for a bioterrorism attack and unlike a bombing or shooting, these microbial agents can incubate for days or weeks going unnoticed until unrelenting illnesses or deaths occur. Bioterrorism became an overwhelming concern after the attacks on September 11th due to the infamous anthrax letters. Of the twenty-two people who had come in contact with anthrax-laced letters, 5 died due to misdiagnosis and inaccurate testing while approximately 30,000 more required prophylactic antibiotics. It became clear how grossly unprepared we were for biological warfare and in 2004, Congress passed the Project Bioshield Act which allocated $5 billion to facilitate the development, acquisition, and stockpiling of diagnostics, vaccines, and medications against chemical, biological, radiological, and nuclear (CBRN) threats.

Since then, many questions have arisen about the necessity of Project Bioshield. Proponents of bioterrorism research agree that continued research and development of treatments is needed to protect people in the event of future terrorist attacks. While security is the impetus of Project Bioshield, questions about ethics and funding are center stage in the discussion of the relevance of this initiative.

PROBLEMS & CRITICISMS


Inadequate partnerships

Finding qualified pharmaceutical companies to develop and deliver the necessary vaccines has not been easy. An early example of this is the failing of VaxGen. They were initially contracted as one of Project Bioshield’s earliest developers of Anthrax vaccines and tasked with delivering 25 million doses of the vaccine in 2 years, an impossible task for even some of the largest manufacturers. In addition, VaxGen lacked proper in-house expertise which contributed to missed deadlines, inadequate testing and limited resources for funding. This $877 million blunder put a microscope on how Project Bioshield was procuring contractors and if they could meet the stringent demands of the government.     

Bioshield Funding Is Needed Elsewhere

The Project Bioshield Act was signed by President Bush with an initial appropriation of $5.6 billion over a 10 year period. In 2013, Congress reauthorized Project Bioshield with annual funding at $2.8 billion. “The cost of defending the United States against bioterrorism raises a host of issues, says David Krause, MD, of Vicuron Pharmaceuticals. If we fund this, what are we not funding?” he asks. “And can we ever predict all the possible terror threats?” This question is backed with valid concerns at a time where deficits are growing and active diseases currently impacting the public are becoming commonplace with little to no funding to combat them. Opponents argue whether or not funding should be redirected to the public health system, infrastructure, and other vital systems that affect citizens.

The Odds of Another Bioterrorism Attack

Throughout history, humans have used biological agents for warfare purposes. From cadavers used to spoil water supplies of enemies to catapulting plague-infected corpses across walls to cause a mass exodus, the use of both pathogens and toxins to immobilize the enemy has been used throughout human warfare. Thanks to medical and technological advancements, as well as treaties like the Geneva Protocol, the probability of another massive biological attack, has been reduced significantly. Although investment in biosecurity isn’t without merit, the amount of investment and resources allocated aren’t absolutely refutable. Are we preparing for something that may never happen again?

 

SOLUTIONS & OUTCOMES


Development of Crucial Medical Countermeasures

Emergency preparedness means accessibility to treatments, vaccines, and effective medication for as many people as possible during times of duress. This is why agencies like BARDA Biomedical Advanced Research Development Authority, are so critical. Beyond overseeing Project Bioshield, BARDA’s focus is to secure the U.S. from CBRN threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID) through focused funding, research and technical support and services. This increased scope has allowed BARDA to procure and stockpile 21 products for use in potential public health emergencies such as botulism, anthrax and smallpox. Six of those products have been approved by the FDA and more approvals are expected in the next couple of years.

 

The Advancement of Medicine & Debilitation of Disease

The CDC estimates that drug-resistant bacterial infections affect 2 million people and kill 23,000 people in the U.S. each year at a financial cost of $20-35 billion. Recent studies show that if this trend continues, resistance to antibiotics could cause more deaths than cancer by 2050. Antibiotics are an indispensable part of modern medicine but with bacteria increasingly becoming resistant their effectiveness is diminishing. Over the last several decades, there has been a continual withdrawal of pharmaceutical companies engaged in developing new antibiotics while major drug companies have cut back or pulled out of antibiotic research and development simultaneously. In an effort to get ahead of this deficit, BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) have joined forces to create CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), the world’s largest public-private partnership focused on preclinical discovery and development of new antibacterial products to help address the threat of antibiotic resistance. In 2017, CARB-X announced an initial injection of $48 million for drug discovery and development projects focused on tackling antibiotic resistance.

It has been nearly 18 years since the anthrax attacks of 2001 and national preparedness for a biological attack has been fused into national security. Despite criticism, BARDA has taken meaningful steps to reduce wasteful spending, identified knowledge gaps in our ability to manage drug-resistant strains and made medical countermeasures a top priority. There are several valid questions and arguments on both sides of the biowarfare discussion, many of which will be answered as our capabilities in both the medical and technology industries increase. Regardless of one’s position, I think we can all agree that public health and safety are paramount.


HOW RUBIX CAN HELP

As the landscape of bioterrorism evolves, completing assessments for innovation deployment remains at an all-time high.  We’ve assessed, developed, and deployed technologies in stretches of the world that are vulnerable to threats that would diminish life as we know it.  The ability to proactively counteract and predict actions that can affect societal health is one of our principal concerns. As many of the countermeasures deployed have been ineffective, partnering with Rubix LS augments aggressive development that isn’t focused on a symptomatic measure but for an overall ‘one-solution’ program that can thwart evolving threats.