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.