When it comes to emergency disaster planning, the elephant in the room has long been a nuclear attack or, more recently, the detonating of a "dirty bomb" designed to spread radiation.
With the potential damage so enormous, the federal and local governments have struggled in their efforts to plan for the damage from nuclear explosions, and there has been limited progress since the fallout shelter craze of the 1950s and 1960s.
But all that was supposed to change after the Sept. 11 and anthrax attacks in 2001, when Congress and President Bush pushed through the BioShield Act as a way to jump-start drug company efforts to find and manufacture antidotes and vaccines. While protection from biological and chemical weapons is a major focus of the bill, the absolute top priority is generally described as preparing for a possible nuclear attack by terrorists or a rogue nation such as North Korea.
That effort, however, has by most accounts bogged down and shown few results. That in turn has led to some sharp and public questioning of the federal agency in control of the effort, the Department of Health and Human Services.
In particular, the company Hollis-Eden Pharmaceuticals, and many legislators that support the company's efforts, have been highly critical of the agency's handling of the radiation sickness drug that it has been developing for five years.
The company says that the drug, called Neumune and developed with the support and oversight of the Defense Department, is the only one that will be ready to protect Americans exposed to radiation within the next few years, and yet HHS has moved with little sense of urgency in its procurement process. In limited studies involving primates, the company found that 90 percent of the animals given the drug survived sustained radiation exposure, while just 55 percent of the untreated group survived.
Testifying in July before the House Committee on Government Reform, company CEO Richard Hollis accused the federal effort of having "a lack of leadership, a lack of implementation and sense of urgency, and a huge sense of bureaucracy, that has basically killed the capital markets and ability to raise money to develop these drugs."
With very few drug companies still interested in developing BioShield drugs and vaccines because of doubts they could make money or, for that matter, break even, Hollis said, it seems counterproductive to demoralize those few that remain involved.
During that hearing, lawmakers including Reps. Thomas M. Davis III (R-Va.), Darrell Issa (R-Calif.) and Henry A. Waxman (D-Calif.) agreed that HHS needed to move more quickly.
Stewart Simonson, HHS assistant secretary for public health emergency preparedness, replied that the agency was itself not satisfied with its progress, and that a formal draft request for proposal for a radiation sickness drug would be out by the end of July. Two weeks later, however, the agency postponed the announcement.
HHS spokesman Marc Wolfson said the delay was needed to "insure that the most appropriate immediate targets . . . can be more fully defined to protect the American public." He also said the delay would allow the agency to provide the best guidance to drugmakers.
HHS has again promised a draft request for proposal, this time by the end of this month. Legislators, and companies interested in developing drugs under BioShield, are watching the long-delayed announcement closely to see whether it will speed the procurement process or slow it further.