This month marks the sixth anniversary since anthrax-laced letters were discovered in the U.S. mail. It is therefore reasonable to ask whether the nation now has the medical countermeasures needed to prevent and treat diseases from known biothreats.
By Anita Cicero|October 08, 2007 at 12:00 AM|Originally published on Legal Times
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This month marks the sixth anniversary since anthrax-laced letters were discovered in the U.S. mail. Five people died, and the perpetrator is still at large. With the passage of time comes some level of complacency. And yet the relatively modest death toll from the anthrax attacks belies the continuing power of biological agents to bring about large-scale disruption and catastrophic loss of life, even in the hands of an unsophisticated enemy. It is therefore reasonable to ask whether the nation now has the medical countermeasures needed to prevent and treat diseases from known biothreats. The current answer to that is no. But the United States does have robust tools such as the Project BioShield legislation and the newly established Biomedical Advanced Research and Development Authority in the Department of Health and Human Services that offer significant promise if used to their potential. The United States has an urgent need to acquire as yet undeveloped vaccines and therapeutics that can be used to treat destabilizing infectious disease outbreaks and bioterrorism pathogens that pose grave risks to public health and national security. The Centers for Disease Control and Prevention have identified anthrax, botulism, plague, smallpox, tularemia, and viral hemorrhagic fevers (such as the Ebola and Marburg viruses) as “Category A” agents that present national security risks. A number of other agents listed in categories B and C are also known to present high risks. The bracing fact is that the list of pathogens that could naturally emerge or be engineered to cause mass fatalities is not limited to the CDC’s list. The actual list is growing and virtually endless. It is now possible to genetically alter microbes, both for noble purposes as well as for malevolent ones. Antibiotic-resistant pathogens may even be synthesized from scratch. The United States needs to be more proactive to keep pace with science. Real progress defined as medical countermeasures purchased for the Strategic National Stockpile will come about only from (1) increased partnerships between government and the nascent biodefense industry, and (2) much higher levels of congressional funding for inherently risky countermeasure development projects. Recent progress has been made on the first element. Perhaps if the momentum continues toward strong, dynamic public-private partnerships in this area, the second element also will be achieved. During a Rose Garden ceremony in 2004, President George W. Bush signed into law the Project BioShield Act, which authorized $5.6 billion over 10 years to purchase medical countermeasures for the Strategic National Stockpile. In an earlier speech, the president explained that BioShield would “speed the research, production, and availability of effective vaccines and treatments against smallpox and anthrax, botulinum toxin, Ebola, plague and other possible agents of bioterror.” Unfortunately, BioShield’s promise of accelerating R&D of countermeasures has yet to be realized. Some BioShield contracts have been awarded (e.g., a small contract for an anthrax monoclonal antibody, some contracts for countermeasures to treat radiation-induced illnesses, a contract for a botulinum antitoxin, and more recently, sizable contracts for a Modified Vaccinia Ankara smallpox vaccine and an anthrax vaccine). But BioShield has been more often characterized by delays, technical hurdles, a lack of transparency, and other barriers to contract awards. Project BioShield was landmark legislation, signaling the government’s interest in creating a biodefense industry. But BioShield never did entice big pharma to actively engage in medical countermeasure development primarily because the lost opportunity costs are simply too high for pharma and because there has not been a political appetite to provide other effective incentives. A number of smaller biotechs were initially enthusiastic about competing for BioShield contracts, but many original players have since dropped out. Some previous problems cited by companies include:
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