A leading federal WMD defense program can cite significant successes in eight years of operations, but continues to face major complications and threats to its pool of funding.
Project Bioshield was established in July 2004 with a $5.6 billion war chest intended to spur private production of medical countermeasures that would be used to treat victims of an act of bioterrorism or other unconventional weapons event. It has added a host of new drugs to the Strategic National Stockpile of protective drugs, the Health and Human Services Department said in a September report on program activities in 2011.
"The medical countermeasures pipeline has never held more promise than it does today," HHS Assistant Secretary Nicole Lurie, who heads the department's preparedness and response activities, wrote in the report. "Innovation, enhanced partnerships and collaboration, and sustained investments throughout the last decade have resulted in the addition of eight new countermeasures in the Strategic National Stockpile (SNS), able to treat the effects of anthrax, botulism, smallpox, and radiological and nuclear agents."
By the end of 2011, the Bioshield Special Reserve Fund had allocated more than $2.6 billion for massive stocks of vaccines and other medicines, the report indicates. Among the acquisitions: 28.75 million doses of BioThrax, the only anthrax vaccine certified by the Food and Drug Administration; 4.8 million doses of a drug for treating people exposed to radiation; and 107,560 doses of a botulism antitoxin.
The procurement process, though, has been given to hiccups since its inception. Bioshield’s first planned big acquisition -- 75 million doses of a new anthrax vaccine -- collapsed in late 2006 and California-based producer VaxGen never recovered.
More recently, the program awarded a single-bid contract for SIGA Technologies to produce 1.7 million doses of the smallpox drug ST-246. The firm’s top shareholder is a wealthy backer of the Democratic Party, while a member of its board of directors also reportedly has ties to the White House. Those connections have provoked concern on Capitol Hill about whether the company received preferential treatment. There also have been questions about the efficacy of the drug and the $225 price tag for each dose, which is seen as high.
Danish pharmaceutical firm Bavarian Nordic by December 2011 had shipped 5.9 million doses of a 20 million-dose order of its Imvanune smallpox vaccine. However, the company said last month it faced a dire financial situation as it had not received a new order for the product that provides 95 percent of its revenue, Bloomberg reported.
“They’ve definitely achieved things by making purchases and there are more products available than there were in 2004. There’s still room for improvement in the operations of the program and in the countermeasure development,” said Amesh Adalja, a senior associate with the Center for Biosecurity at the University of Pittsburgh Medical Center.
Others have been less measured. Health and Human Services Secretary Kathleen Sebelius in 2011 said the countermeasure program was “full of leaks, choke points and dead ends." Others have said the original $5.6 billion tranche was simply not enough to attract interest from major drugmakers in turning their work toward the anti-WMD goal.
The “No. 1 priority,” Adalja told Global Security Newswire, should be providing more Food and Drug Administration-licensed drugs and diagnostic tools for Category A bioterrorism agents -- materials such anthrax, plague, smallpox, and tularemia that are considered to pose a high threat to national security. “There are still some gaps that need to be filled,” he added, citing the lack of rapid diagnostic system for any of the Category A materials.
These gaps can be attributed to both Washington and the pharmaceutical companies that would have no other customer for some countermeasures except the government, according to Adalja. He noted as an example that there have been only a handful of naturally-occurring anthrax cases in the United States since 2001 -- not enough to create a private market for a bacteria-defeating drug.
Health and Human Services officials did not respond by press time to multiple requests for comment on the procurement process and other aspects of Project Bioshield.