Company Criticizes HHS BioShield Effort

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."