Homeland Security Watch

News and analysis of critical issues in homeland security

January 3, 2006

Time magazine on the nation’s biodefense woes

Filed under: Biosecurity,Business of HLS — by Christian Beckner on January 3, 2006

The new issue of Time magazine has an excellent article (available here) that harshly indicts the nation’s bioterrorism efforts since 9/11, focusing in on the challenges that have faced the BioShield program since its inception:

Had you listened to President Bush on Jan. 28, 2003, you might think the U.S. would have a bustling biodefense industry by now. In a State of the Union speech laced with references to terrorism, Bush asked Congress for nearly $6 billion to fund Project BioShield, a program he said would “quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, Ebola and plague.” That sounded like a good idea, considering the havoc wrought by the anthrax mailings of 2001, which killed five people and set off a near panic for treatment. So Congress anted up. Eighteen months later, Bush signed BioShield into law. The measure set aside $5.6 billion for drug companies, offered the promise of a guaranteed and speedy contract–even an opportunity to sell the government novel treatments before they are fully approved by the Food and Drug Administration (FDA). The law, Bush promised, “will transform our ability to defend the nation.”

Yet BioShield hasn’t transformed much of anything besides expanding the federal bureaucracy. Most of the big pharmaceutical and biotech firms want nothing to do with developing biodefense drugs. The little companies that are vying for deals say they are being stymied by an opaque and glacially slow contracting process. The one big contract that has been awarded–for 75 million doses of a next-generation anthrax vaccine–is tangled in controversy; it went to a California firm, VaxGen, which in its 10-year history has never brought a drug to market. In the scientific community, biodefense is viewed as yet another boondoggle that is sucking money and resources from critical public-health needs like new antibiotics and vaccines. Indeed, the consensus outside the Administration is that the program is broken before it even gets off the ground. “BioShield has failed miserably,” says Jerome Hauer, a former senior official with the Department of Health and Human Services (HHS). “The intent of BioShield was to attract new companies to get involved in developing countermeasures. It has not only failed to do that; it has kept a lot of other companies away because they’re so concerned about the program’s lack of focus and direction.”

There are a number of reasons for this, which the article details – liability issues, insufficient profit incentives for large pharma companies – but I think the single most important reason has been the fractured responsibility for the management of bioterrorism in the federal government. As I mentioned in this earlier post, there are too many cooks in the kitchen on bioterrorism issues today: HHS (incl. FDA, NIH), CDC, DHS, DOD, etc…

The article discusses the consequences of this fractured governance structure:

…CEO Dave Wright has been shuffled from the FDA to the Department of Homeland Security and HHS and still isn’t certain what the drug must do to receive FDA approval. In a meeting with HHS officials last August, he wanted to know if he’d lose points on a contract if he were to manufacture the drug abroad, where production would be cheaper. Sorry, he was told, that couldn’t be discussed because a contracting officer wasn’t in the room. What about whether the feds would like it in a tablet or syringe? Sorry, couldn’t tell you that either. Meanwhile, Wright is weighing whether to invest $8 million to scale up manufacturing. “And they want to know why no one wants this business?” he asks.

This is an issue that begs for immediate senior-level attention from the White House and Congress, and the avian flu threat adds new urgency to this need. Tough decisions need to be made to streamline authority and lean hard on the key agencies to get them to reduce red tape, work together, and move a lot faster toward where we need to be.

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2 Comments »

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Comment by J.

January 3, 2006 @ 4:24 pm

I am looking forward to reading the article, but would offer the point that I don’t see the involvement of multiple agencies as the issue here. Yes, there are lots of feds involved in biodefense, but when it comes to vaccines and medical countermeasures, there are really only two major players – DOD doing R&D for vaccines for military (healthy young) personnel, and DHHS heading BioShield and trying to get vaccines for the general population (sensitive old and very young population). The problem is inherently within DHHS. Prior to 2003, DHHS has never been involved in R&D – at all. They sponsor grants and oversee public health issues, but they have zero background in R&D, which is why they’re so damn cautious about contracting – they know they could get jammed if they make a mistake on a very visible, multi-billion dollar effort that basically could provide untested and unvalidated vaccines to the general public if a terrorist bio incident occurred. DHHS does not know how to plan for a multi-year (10-15 year) R&D effort, let alone figure out how to woo the big pharma players.

DHS has BioWatch, EPA isn’t a lead player, FDA just certifies, CDC is more into medical surveillance, DOD just supports but has primary for battlefield biodefense, etc etc. It makes for noisy meetings but I think the players all understand their roles. As you point out, it may be just the lack of senior and adult leadership.

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Pingback by Homeland Security Watch » Blog Archive » Bioterrorism and the “next war”

January 13, 2006 @ 10:20 pm

[…] This article makes me wonder if we need a new institution that can focus on developing these long-term capabilities, without the burden of short-term pressures and requirements. I’ve complained previously about the splintered nature of responsibility for bioterrorism in the federal government, but this might be one area where a siloed institution would have some real value. Perhaps the recent Senate proposal to create a Biomedical Advanced Research and Development Agency (BARDA), following the DARPA model, could be the right vehicle for this, although in the current bill language, BARDA has a lot of near-term responsibilities. […]

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