Oct 26, 2011

Bioterrorism Preparedness - Shortcomings & Clusterfuckery

Next Sunday's NYT Magazine will feature a piece on possible shortcomings (and actual clusterfuckery) in US preparedness against bioterrorism.

The Article explains why we have not yet developed a needed new Anthrax vaccine:

Five years later, the cancellation of that contract is still a matter of fierce debate in biodefense circles. Many experts say that the decision had less to do with science than politics. Scott Lilly, a senior fellow at the Center for American Progress, recently studied the role that lobbying may have played in VaxGen’s demise. Between 2004 and 2006, Lilly writes in a new study, the company that produced the old anthrax vaccine, which is now called Emergent BioSolutions, employed an army of lobbyists to undermine the VaxGen contract. “Each time VaxGen’s test results were less than had been hoped for,” the report says, “Emergent pounded VaxGen with a highly orchestrated campaign to overstate the problems and discourage government support of the effort.” 


General Russell, who led the early countermeasure program, told me: “It was Emergent lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen.” Several current officials share Russell’s view. When I asked one senior biodefense official about the lack of a new anthrax vaccine, the official nearly exploded: “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying!” Even the director of Barda, Robin Robinson, acknowledged that politics played a role in the decision. “Should we have kept it? I think there’s a long debate,” he said. “They had brought in some really top-flight people in there, and Lance Gordon was really good at judging talent. Unfortunately, there was a lot of political pressure.”

Soon after the VaxGen contract failed, the company folded into another, and Emergent bought the rights to develop the new anthrax vaccine it had spent three years lobbying against. Abdun-Nabi told me his company was still trying to develop that vaccine, but critics question whether Emergent, which signed another contract this month to deliver $1.25 billion more of the old vaccine to the stockpile, is pursuing the replacement vaccine as enthusiastically as possible. “They bought the technology and buried it,” Russell says. “We are five or six years behind where we should be. We should be working on a third-generation vaccine.”

There are disagreements over how far afield we should be looking past the two main bioterror threats: smallpox and anthrax:

In fact, other than the vaccines for anthrax and smallpox, there are no vaccines in the stockpile for any other agents on the material-threat list, nor are any of those vaccines in the advanced development program, nor will any of them enter the program any time soon.


Many agents on the list, Fauci said, were a product of the cold war, when the U.S. military kept a list of “Category A” pathogens being developed by the Soviet bioweapons program. “So when the decision was made to make an investment into developing countermeasures,” he told me, “that was essentially their matrix from the beginning: these are what we know the Soviets had. We know they have stockpiles. This is what we’re going to protect against.” He mentioned the bacterium glanders, which was reportedly used by Germany in World War I and by Japan in World War II but seemed to Fauci a comparatively minor threat today. “I think the unknown threat of a mutant microbe is infinitely greater than someone coming and dropping a glanders on us!” he said. “I mean, seriously! Get real about that!”

When I mentioned Fauci’s comments to O’Toole, who oversees the biological-threat list at the Department of Homeland Security, she said he was “completely wrong” to suggest that the list is rooted in cold-war thinking. “We use current intelligence as an integral part of every material-threat determination,” O’Toole said. “I’m surprised anyone in N.I.H. would think otherwise, particularly since the details of the material-threat determination process are briefed at the White House. It does raise a troubling question about how seriously N.I.H. is engaged in the biodefense mission.”

Whether or not Fauci is right about the origins of the material-threat list, his observation that a natural outbreak is more likely than a biological attack is difficult to dispute. Each year, seasonal flu leads to about 200,000 hospitalizations and several thousand deaths in the United States. Although a biological attack could be much larger, there is no certainty that such an attack will ever happen. How to balance the unlikely but catastrophic potential of bioterror with the steady advance of natural disease is one of the most puzzling challenges for biodefense policy going forward.

To some extent, this is also a question of framework. Fundamentally, the countermeasure program is a public-health project, yet with its reliance on classified intelligence and secret-threat assessments, it is more closely aligned in many respects with the methodology of other national-security projects. Where biodefense fits into government bureaucracy will have a profound impact on its financing. In public health, the $12 billion necessary to develop new vaccines for a dozen material-threat agents can seem a towering, even absurd, figure. Within the realm of national security, the same amount represents less than a quarter of the cost of the military’s experiment with the V-22 Osprey heli-plane, or about what the U.S. will spend in Afghanistan between now and Christmas.

“We spent trillions of dollars in the cold war preparing for a potential nuclear exchange that never occurred,” says Kenneth Bernard, who was the senior biodefense official in the Clinton White House from 1998 to 2001 and then again in the Bush White House from 2002 to 2005. “We’re not spending that kind of money to prevent a bio attack because the people who work on biology are not trained to think like that. They are much more interested in dealing with the three particular strains of influenza that are in the dish this year than they are in thinking about a plague attack in 2018.”


mark brenneman said...

CBER helps give a starting direction for starters, when there is more to a defined meaning that directs a search back to 2002 on the anthrax Bacillus side of the issue the other is most people don't know there are true or false test for both issues or incidences of the other easily confused viruses. But corp. structures rely on tenure issues to have viable address in the US and the committees established here are also downsized and closed for business also as well as the titles medical personnel been hanging on da end of deres names but somebody could establish the hierarchy easy enough from around here to anybodys postdate creds..

Regulation of the Anthrax Vaccine, Adsorbed

mark brenneman said...
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