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.
In the July hearing, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci expanded on the problems he said the government faces.
Fauci seemed to dismiss Neumune as a solution, saying that "we have to almost start from square one" regarding a radiation sickness drug. He said that the changed nature of the nuclear threat -- from a massive attack by the Soviet Union to a single blast or dirty bomb from a terrorist -- required new research into new solutions.
"It was either you blow up the city or not," Fauci said. "It's a totally different picture now, which is the reason why the research is taking time."
Fauci's description of a changed nuclear reality is reflected in a 2002 study by the British Medical Journal. The study estimated that a bomb the size of the one that caused the Hiroshima blast -- very small by current standards -- detonated in New York City would kill at least 50,000 people instantly; 200,000 would be expected to die later from acute radiation syndrome; 700,000 more would be sickened from that condition.
That changed threat -- where radiation sickness would claim many more lives than the actual blast -- creates opportunities to save people. Radiation sickness is the result of bone marrow damage, which in turn leads to the loss of infection-fighting cells and clotting factors that limit bleeding. In the event of acute radiation exposure, scientists say, most casualties would come from uncontrolled infections and bleeding.
What Neumune's makers say is that their drug, a steroid, can protect bone marrow from radiation. The drug, which would be self-injected before or soon after exposure, could theoretically save many thousands of people downwind from the nuclear blast. The drug has its limitations -- it has to be taken within four hours of exposure -- but it does have a three-year shelf life that company officials say would allow it to be stored at government sites or in homes.
The only other radiation treatments in the national stockpile are potassium iodide, which can protect the thyroid gland from future cancers, and several compounds that can help flush some radiation out of the system. Fauci's institute has been experimenting as well with Neupogen, a drug used to help restore bone marrow damaged when cancer patients receive radiation treatment.
Hollis-Eden officials, and numerous lawmakers, acknowledge that other drugs might hold promise in the future, but say that Neumune offers the best chance for radiation sickness protection in the near term.
"We don't understand the delay here because there is no other drug that fits the post-nuclear attack scenario," said Bob Marsella, a vice president of Hollis-Eden. He called the slow-paced decision-making "inexcusable, given that the federal government's own lead agency, [the Armed Forces Radiobiology Research Institute], has identified our drug as the only drug that meets the criteria for a BioShield contract for acute radiation syndrome."