Can the Administration Deliver on Bioshield?

J0321193 On Friday, VaxGen shares feel 37% after it was reported that the company was going to file a legal claim against the government over its contract to produce an anthrax vaccine.  First awarded in November 2004, reports this past week state that the company may experience delays that taken the finished product into 2008 or 2009.  This is one of the centerpieces of Project Bioshield that is supposed to be providing "new tools" in the face of a terrorist attack.

In theory, it is not a bad idea.  Look at the speed at which emerging pathogens have been emerging.  Other than annually evolving flu strains, I was not aware of emerging pathogens until the AIDS epidemic came along like a train in the night and turned our lives upside down within a few years.  Since then, there have been countless others – Ebola, West Nile Virus, Marburg Virus, Multi-drug resistant tuberculosis, SARS and of course, the threat of an Avian flu pandemic. 

Emerging pathogens emerge with a speed that is not tied to government action or inaction.  They proceed along their own timeline.  With AIDS, the first cases were reported in 1981.  Five years later, thousands in the U.S. had died.  Largely, at that time, the government was "inactive."

But now the government is geared up, in order to fight terror.  First on the agenda appears to be this anthrax vaccine.  What stands in the way?

First, it is difficult to imagine in this post-Vioxx environment where the emphasis in the risk-benefit ratio has shifted so dramatically to risk over benefit, that a vaccine can be produced in really short order that satisfies the rigorous standards for safety that exist in our drug approval system. 

Second, we have to keep in mind the government’s response during the last anthrax outbreak when there was a communications trainwreck and about the best thing they could tell people was to wear gloves when opening their mail and to buy some duct tape. 

In fact, to be really effective, we have to have a system that is every bit as stealth in development of drugs as the emerging pathogen we seek to fight.  Not only are drug manufacturers being asked to develop drugs in short order, they are also being asked to develop tests that screen for pathogens.  In order for that to happen, there needs to be market incentive for manufacturers to research, test and implement a process for manufacturing in a really abbreviated time period.  If the government mis-steps in that effort or fails to pay attention to the private sector realities of the situation and the current environment, it is not likely, however aptly named, that an effort like Project Bioshield will make it off the shelf. 

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