From Russia with Drugs: Innovative Sources for Medical Countermeasures to Bioterrorism

April 24, 2007

Five years after anthrax-laced letters killed seven people and sickened dozens of others, the apparent vulnerability of the United States to bioterrorism has hastened a dramatic reordering of government spending. Since 2001, civilian biodefense budgets have risen to well over $5 billion annually. But while financial resources have grown substantially, the United States remains unprepared for any significant biological incident.

Today, civilian biodefense spending is spread across multiple US government agencies including the Departments of Health and Human Services, Homeland Security, Defense, Agriculture, the Environmental Protection Agency and the National Science Foundation. Among other things, funds are used to develop innovative new vaccines, train first responders, enhance infrastructure protection and emergency preparedness, ensure food safety, and improve biosurveillance capacities in the United States and abroad to ensure rapid detection of disease outbreaks. The full breadth of biodefense activities funded by the federal government is awesome in its scope.

But while money is not in short supply for these activities, the ability to develop and produce innovative new strategies, drugs and vaccines to protect the American people is ultimately limited by both scientific talent and production capacity. The federal government's troubled response to a potential 'bird flu' crisis is telling. Last fall President Bush announced a $7.1 billion strategy to mitigate the next flu pandemic. That plan focused largely on the production of new vaccines once the next 'super-flu' strikes. But despite these new investments, no vaccine is likely to be available for mass production until months after an outbreak. Governments lack the necessary R&D-and more importantly, the production capacity-to bring countermeasure products to market. Therefore, critical to any rapid reaction capability is the cooperation of industry-both R&D and pharmaceutical production companies.

The failure of Project Bioshield to incentivize pharmaceutical companies to engage in what is regarded by industry as a risky and unprofitable business of countermeasure development and production should give the US government additional pause. Established in 2004, the government's $5.6 billion commitment over 10 years for the purchase of next generation countermeasures against an array of biological agents failed to capture the attention-and more importantly, the intellectual capital-of Big Pharma. A nearly $1 billion contract awarded to a small scandal-plagued California-based biotech company to develop a next generation anthrax vaccine, once touted as the landmark deal for Bioshield, has since been cancelled by the US government leaving the program without a significant success story.

Despite these massive cash infusions, this stark reality should give pause: In the event of a bioterrorist attack, assuming vaccine manufacturers globally could find common cause and divert their full attention to producing a single vaccine, over a nine-month period only an estimated 800 million doses could be developed and produced for a global population of over 6 billion. Thus, even if Big Pharma agreed to fully engage in countermeasure development today, the United States and its industry partners would immediately face a crisis of capacity. In short, there simply are not enough trained researchers and drug manufacturers capable of absorbing government research investments effectively.

The threat of bioterrorism, however, is not just a domestic issue for America. No one state can readily prepare itself in isolation to combat the spread of infectious disease-either naturally occurring or deliberately propagated. Infectious agents do not respect borders, and states everywhere could be at risk following an outbreak anywhere. As such, the United States should be aggressive in exploring strategies for international cooperation in its countermeasure development activities. By engaging other countries, the United States government can not only access a significantly expanded array of novel research talent, but if pursued effectively, it can do so at significantly lower cost while leveraging other foreign policy objectives.

Throughout the Cold War, the Soviet Union developed a massive state-owned bioresearch and production capacity. While the Western world funneled its most talented medical researchers and scientists into solving the most vexing public health challenges of the day, Moscow pushed its biggest brains into what became a 60,000-employee strong biological weapons complex. For decades, the Soviet Union attached the highest priority to cultivating unmatched capabilities in working with these agents of war. In turn, it weaponized thousands of tons of viruses, toxins, and bacteria, including anthrax, smallpox, botulinal toxin, and plague.

While many experts believe that the remnants of the Soviet biological weapons complex continue to pose a serious threat, today the capacity resident within that complex also affords unparalleled opportunities to address issues of global public health and meet the continued threat of bioterrorism. Russia retains world class capabilities for tissue culture and is a global leader on the identification and utilization of bacteriophages and novel drug design and testing. To date, the failure to harness these talents for the benefit of humankind has been a direct result of the inability of both Moscow and Washington to transform their contentious relationship of the past into mutually beneficial cooperation in the present.

A new plan to leverage US government civilian biodefense investments with nonproliferation and economic development objectives could yield significant advances in all three areas. Cutting loose a portion of US civilian biodefense spending for use as incentives to the Russian scientific community and private sector is a logical first step toward expedited drug and vaccine development at reduced cost. The average senior level scientists in Russia draw a monthly salary of around $200 per month-a fraction of their American counterparts. Technical capacity in short supply in the United States could be augmented with a new source of highly trained scientists. The equally challenging deficiency in production capacity could also be addressed by the emerging Russian biotech and pharmaceutical sector eager to engage the global marketplace.

Photo credit: McBrugg/iStockphoto

Brian Finlay co-directs the Cooperative Nonproliferation Program, a multifaceted project designed to accelerate existing efforts and design innovative new initiatives aimed at more rapidly and sustainably securing nuclear, biological, and chemical weapons, materials, and expertise.