Opportunity in the still-formative biodefense plan

Eight years and nearly $50 billion after the anthrax mail terror attacks of September and October 2001, the U.S. biodefense effort is better off–but not by much.

Back then, five media outlets–ABC, CBS, NBC, the New York Post, and the National Enquirer–as well as the offices of Senators Patrick Leahy (D-Vt.) and Tom Daschle (D-S.D.) received anthrax-laced letters, and federal officials scrambled to contain the threat and treat the injured. Five died and 17 others required treatment for anthrax-related illness. Today, the nation has a stockpile of anthrax vaccine, about 20 million doses, but some experts warn that the stockpile might not be large enough. Good progress has been made with smallpox vaccines and pandemic-flu drugs, and facilities to mass-produce drugs and vaccines are beginning to come online. In addition, the Department of Homeland Security has deployed a nationwide early warning system that can detect trace amounts of biological materials in the air. Focusing on major urban centers, BioWatch helps public health officials determine the location and extent of a biological agent so they can mobilize an emergency response.

Coordinating these and a host of other biodefense programs across seven federal agencies has proved challenging. Congress didn’t pass the Pandemic and All-Hazards Preparedness Act until December 2006. This piece of legislation outlines responsibilities among key biodefense players. It requires the Secretary of Health and Human Services to take the lead in all public health emergencies, creates the position of an Assistant Secretary for Preparedness and Response within the Department of Health and Human Services, and establishes the National Biodefense Science Board to provide advice on technical and scientific matters related to chemical, biological, radiological, and nuclear threats.

The act also creates the Biomedical Advanced Research and Development Authority (BARDA), which is responsible for developing medical countermeasures to chemical, biological, radiological, and nuclear threats and to provide funding for products ready for Phase II clinical trials. BARDA also oversees development of the infrastructure needed to move products into development. Congress authorized $1 billion for BARDA through 2009 but only $201 million had been appropriated through 2008.

Robin Robinson, who took the reins of BARDA in the spring of 2008, notes that the Obama Administration sees biodefense as a high priority in terms of national security. Robinson has talked at length with transition team members and is hopeful that BARDA’s federal support will increase. “With any young organization you have to perform,” says Robinson. “You have to earn the confidence of others.” The stimulus package recently passed by Congress provides additional funding for BARDA programs.

A commitment to mission

Despite limited resources, Robinson, who successfully headed up the pandemic-flu vaccine program, is committed to his agency and to its mission. “We’re like the little shoemaker. We haven’t stopped moving forward,” he says. “The threats are there so we need products in the pipeline.”

Near the top of Robinson’s “to do” list is development of sixth- and seventh-generation broad-spectrum antibiotics. “Right now the fifth generation is our last hope. If we have something that’s multidrug-resistant we have nowhere to go. We need a better armory,” he says.

In addition, work will move ahead on antiviral drugs because the H1N1 virus is showing resistance to the Tamiflu drug. Robinson anticipates a new class of antivirals in the 2010–2011 timeframe. BARDA has several partners in this effort, including the National Institute of Allergy and Infectious Diseases. In the area of acute radiation syndrome, seven contracts were awarded in the fall of 2008 for development of therapies for illnesses related to the syndrome.

In the area of diagnostics and detection, Robinson says several products are moving through the pipeline both for point-of-care diagnostics and rapid high-throughput diagnostics for medical laboratories. The point-of-care technologies for influenza detection may be available for licensing as early as 2010.

A potential win for business

Should the Obama Administration choose to emphasize biodefense, in particular the development of drugs and diagnostics, many small- to medium-size companies that often require federal dollars to sustain their development efforts could benefit. A document from the Alliance for Biosecurity, “The State of Biosecurity in 2008 and Proposals for a Public/Private Pathway Forward,” suggests that interest in the public and private markets in biodefense from investors and companies has waned in the last two to three years, primarily because of “growing skepticism over the commitment to sustainability of markets for drugs intended only for use in the strategic national stockpile.”

Because biodefense is “essentially a brand new industry,” according to the Alliance for Biosecurity, companies must educate themselves about what the government needs and how best to meet those requests. Because BARDA support kicks in at the so-called “Valley of Death” when products transition from lab to market, Robinson is more than willing to help individual companies understand exactly what the government’s needs are. “Companies realize that advance development support is not a bad thing,” he says.

Creating a flexible defense

Building and maintaining a flexible defense requires four elements, says Robinson: manpower, infrastructure, funding, and leadership. Fostering an environment that encourages individuals committed to the biodefense mission is critical. “We don’t have enough manpower. It’s a very small population of people,” he says.

For the pandemic-flu program, Robinson brought people with the expertise out of retirement to move the program forward. “We assembled a team and generated a critical mass much like the Manhattan Project,” he says. “We will continue to go forward with that type of approach to make sure we don’t get fatigued.”

Developing an infrastructure capable of rapidly scaling up production should a threat occur means building or retrofitting existing facilities. In 2007 HHS awarded contracts to retrofit existing facilities that are expected to produce 100 million doses of pandemic flu vaccine by 2010.

As for funding and leadership, Congress and the new administration will determine just how nimble the U.S. will be in responding to a biological or chemical threat.