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Bush administration rejects development of radiation drug

WASHINGTON—In another setback to the government's efforts to defend against nuclear or radiological weapons, the Bush administration on Wednesday halted plans to buy a pioneering drug to treat victims of a potential attack.

Department of Health and Human Services officials said that no available product met the government's requirements. The agency had debated for more than a year whether to award a contract for enough medicine to treat up to 100,000 people to a California biotech company. The company says its drug protects bone marrow, the vital blood-forming tissue that's most susceptible to radiation.

The controversial decision drew criticism from members of Congress and was yet another stumble for the Project BioShield program, which was created to stockpile drugs that could limit casualties in a biological, chemical, radiological or nuclear attack.

It also leaves the government with an emergency stockpile of outdated anti-radiation drugs, even as Bush administration officials warn of the mounting threat of a nuclear or "dirty bomb" attack.

In postponing a decision three times since last summer, HHS officials had expressed concerns that the drug, developed by military researchers and licensed to San Diego-based Hollis-Eden Pharmaceuticals Inc., must be administered within four hours of radiation exposure.

That could limit its use against acute radiation syndrome, the officials said, because first responders are unlikely to be able to reach most victims in a nuclear blast zone for at least 24 hours.

The company, which has lobbied Washington aggressively, argued that the drug could be deployed strategically to overcome the time limit. Instead, the government will rewrite its criteria and open a new round of bidding.

HHS spokesman Bill Hall said he couldn't discuss why the Hollis-Eden drug was rejected or whether others were considered, calling such information "sensitive" and "proprietary."

"We determined after very rigorous scientific and technical review that no competing product out there met our requirements," he said. "That doesn't change our commitment for purchasing products for all types of radiological and nuclear threats."

Richard Hollis, Hollis-Eden's chairman and chief executive officer, expressed shock at the decision.

"We've been told all along that we were in the competitive range," he said, adding that the company had "met and exceeded" the proposal's requirements. "In October, we were told we were moving towards a final proposal and award."

Wednesday's decision is the latest setback for Project BioShield, whose mission is to spend $5.6 billion over 10 years to build a stockpile of medicines in the event that terrorists unleash a biological, chemical, radiological or nuclear attack. Last December, the agency canceled an $877 million contract with VaxGen Inc. to develop a new vaccine to protect people who inhale deadly anthrax germs because the company had missed performance milestones.

To date, the BioShield program has spent nearly $800 million on drugs for biological threats and $27.6 million on radiation treatments.

At least two senior members of Congress greeted Wednesday's decision with deep concern.

"It seems as though HHS has dropped the ball," said Rep. Bennie Thompson, D-Miss., chairman of the House Homeland Security Committee. He said a committee panel would hold a hearing on the issue next month.

Rep. Tom Davis, R-Va., who as chairman of the House Government Reform Committee called Hollis to testify last year, considers it "unacceptable that we continue to lack medical countermeasures to radiation poisoning," spokesman Brian McNicoll said.

The decision was a major blow to Hollis-Eden, a small biotech firm that was coaxed into spending more than $85 million to pursue the contract by military researchers who developed the drug after searching for anti-radiation medicine for more than 30 years.

Defenders of the drug, which Hollis-Eden planned to market as Neumune, argued that it requires no refrigeration and could be deployed in advance so it would be readily accessible to emergency responders. They said it could be used for hundreds of thousands of people fleeing radioactive fallout stretching 200 miles or more.

People potentially exposed to radiation from a dirty bomb, in which conventional explosives would spread radiation in a section of a city, or from an accident or terrorist attack at a nuclear power plant might be able to scurry out of the hot zone for quick treatment, they argued.

Gerard Wagemaker, a world-renowned bone marrow expert at the Erasmus University Medical Centre in Rotterdam, the Netherlands, who's consulted for the company, said the drug would save a "a very small percentage of the population" in the outer ring of a nuclear blast zone. Those who got the heaviest radiation doses, he said, would die from damage to their gastrointestinal tracts and brains or from skin burns.

But he called the drug, which still needs to clear pivotal safety trials to win Food and Drug Administration approval, a "potential breakthrough."

Neumune, which requires five daily injections, is one of only two compounds shown in animal studies to regenerate life-sustaining bone-marrow stem cells, and the other drug has shown adverse effects.

Radiation kills white blood cells, which are the body's main defense in fighting infections, and platelets, the clotting component in blood that prevents a person from unchecked internal bleeding.

Neumune, derived from a naturally occurring steroid hormone, was shown in monkey studies to promote the growth of both white blood cells and platelets.


(c) 2007, McClatchy-Tribune Information Services.

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