A Meager Yield From BioShield
A federal effort to protect the public from bioterrorism isn't off to a strong start
Richard Hollis says he was just "trying to be a corporate patriot." The CEO of Hollis-Eden Pharmaceuticals was approached by the Pentagon two weeks after 9/11 and asked to develop a promising chemical compound as a treatment for nuclear attack victims. Three years later, when the Department of Health and Human Services began to explore adding such a product to the national stockpile, Hollis applied. Although he says his medicine produces a "statistically significant survival rate" in radiated monkeys, the feds stalled, pushing back their decision date four times. Finally in March, they told Hollis his drug didn't meet the requirements, even though he'd spent $90 million. The feds then dropped the request for drugs to treat severe radiation exposure.
Because of confidentiality agreements, HHS can't comment on the decision, although sources say there were questions about the drug's effectiveness and expense. Whatever the truth, it's just the latest controversy facing Project BioShield, a multibillion-dollar effort to procure medicines and vaccines for terrorist attacks involving weapons of mass destruction. The program was meant to be the crown jewel of the administration's strategy against such threats at home. Almost three years in, however, the largest contract let so far- for anthrax vaccine-has been dropped. And efforts to buy drugs for other threats like smallpox are stalled. Congress passed a bill in December to fix the situation, but things only seem to have gotten worse. "I can't even tell you how frustrated I am," says Rep. Mike Rogers of Michigan, who calls HHS's management "bordering on dysfunctional." And it's unclear if the chinks in the BioShield can be fixed anytime soon.
Beginnings. After a push by the Bush administration, Congress passed a bill in 2004 to dole out $5.6 billion to HHS over 10 years for medicines to treat or inoculate against WMD exposure. The drug industry praised the concept of the government creating a market for such drugs, and quick results were expected: BioShield allowed firms to get Food and Drug Administration approval for drugs after only minimal human testing.
But almost immediately, there were problems. Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland, says the Department of Homeland Security, which had to do a threat analysis of viruses, toxins, and chemicals before HHS could buy medicines for them, "put a virtual stranglehold" on BioShield with delays. And the first major contract awarded-$877.5 million for production of enough anthrax vaccine for 25 million people-sparked a firestorm. No large pharmaceutical or biotech companies competed, and a small Brisbane, Calif., firm, VaxGen, secured the award, even though it had never produced an FDA-approved product. The task: to take a technology developed by the Army and turn it into a vaccine within five years, half the industry standard. The controversial award became a cause célèbre on Capitol Hill, where a competing vaccine firm engaged in a $1.3 million lobbying campaign to get its own piece of the action.
The drugs BioShield actually bought were mostly the "lowest of the lowest- hanging fruit," says one congressional staffer. The government scooped up 4.9 million children's doses of liquid potassium iodide, a drug used for years to treat less-severe radiation sickness. And HHS bought enough of the other, 1970s-era anthrax vaccine to treat 1.6 million victims. A request for a next-generation smallpox vaccine, meanwhile, was put out in 2005 but remains unfilled.
This past December, Congress aimed to fix some of BioShield's problems-low participation in the program and meager results-by revamping it. Under the new law, instead of being paid only when a product is fully delivered, drug firms will receive funds when they meet major milestones, which makes BioShield less risky for them. HHS also gets access to real-time test data and for the first time can contract directly with universities that have promising products. "Every research bench in the country," says Sen. Richard Burr, the bill's author, "is now open to us."
But Richard Hollis says there's still plenty about BioShield that may scare companies off. HHS dropped that VaxGen contract the day the new bill was signed because of a missed deadline. The House and Senate, meanwhile, are planning a series of hearings this spring. Even so, Carol Linden of HHS insists 2007 will be a "big year" for BioShield: Her agency has almost finished a road map for how to deal with 15 WMD threats and will soon release a new anthrax strategy and a new request for acute radiation drugs. "We are nowhere near where we should be," she says, "but it's the nature of the business that developing [drugs and vaccines] ... takes years and some failures." One hopes America has the time to wait.
This story appears in the March 26, 2007 print edition of U.S. News & World Report.