Project BioShield on the brink of death as competing vaccine firms collide

Anthrax, unless weaponized into aerosol form, is not the most virulent of diseases. The symptoms of infection are severe, but the bacteria itself is not very communicable, making it a doubtful weapon of urban mass destruction. The bacteria is nevertheless at the forefront of the U.S. government’s counter-bioterror efforts, not because of any objective analysis of the threat but because it is — aside from the 1984 introduction of salmonella to a salad bar in Oregon by the now-forgotten Bhagwan Shree Rajneesh cult — the only bioterror American citizens have known. As it was recently with the liquid bomb plot in London, planners jumped immediately after the post-9/11 anthrax attacks to try to stockpile old vaccines and develop new ones. The result was Project Bioshield, a $5.6 billion effort that, five years later, has nothing to show for itself. The worst outcome of the 2001 attacks, it seems, was to demoralize government planners and put two anthrax companies at each other’s throats. The upside? There does not seem to be one.

The Project Bioshield story begins with President Bush’s 28 January 2003 State of the Union. Bush asked Congress for nearly $6 billion to fund Project BioShield to “quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, Ebola and plague,” although all involved understood that anthrax research would receive most of the focus (and money). Of course, there already existed an anthrax vaccine, developed and produced by Gaithersburg, Maryland-based Emergent BioSolutions (previously known as BioPort and based in Lansing, Michigan), but that vaccine had come under severe criticism as part of the U.S. Army’s attempt to vaccinate its soldiers. Six had died from complications, and the government hoped a newer vaccine would be safer and easier to use — one drawback of the Emergent vaccine was that it required a series of six injections over eighteen months.

Yet in its rush to develop an alternative, the federal government made a number of missteps. First, it decided to award the $900 contract to a single company rather than spread out the work among a number of contractors. If it had chosen a reputable company that might have been fine, but large companies were not interested in competing because the payoff was perceived to be quite low: the winning company would produce seventy-five million doses for a government stockpile and that would be that. There were no other commercial applications. Biodefense is “not attractive to Big Pharma, which is making money off things we use a few times a day,” says Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland. So instead the contract went to VaxGen, a small company that had never taken a drug to market, whose only major product, an AIDS vaccine, flopped in 2003, and which was barred from Nasdaq in 2004 after managers uncovered accounting errors. Most distressing of all, “tests in early 2005 showed that an ingredient added to the vaccine caused it to decompose. It would not survive long in the emergency stockpile,” the New York Times reported.

The news that VaxGen was failing opened an opportunity for Emergent, previously the nation’s sole producer of an anthrax vaccine. The company immediately hired a dream team of lobbyists to plead its case in Washington, D.C. Mainly, however, the lobbyists bad-mouthed VaxGen: “VaxGen has a history of failure and irregularities,” their briefing books said. “VaxGen has never produced an F.D.A.-approved product,” and its “vaccine is based on unproven technology,” leaving “the health and protection of the American public on a company with a history of scientific failure and financial scandal.” VaxGen tried to fight back but was overwhelmed. The government agreed in May to double its order of Emergent’s vaccine to ten million doses, worth $243 million and demanded that VaxGen undertake additional safety and efficacy tests that the company says will further delay delivery by a year or two. Vaxgen is also threatening to sue and is demanding upfront payments for further work. If no agreement is reached, says health officials, the entire deal could collapse.

-read more in Eric Lipton’s New York Times report [/url