Health and Human Services moves slowly on radiation treatments.
First it was Iran. Then it was North Korea. On the international stage, the debate rages over what to do about nuclear weapons. Here at home, argument also dominates discussion of U.S. preparedness for a nuclear strike.
The Health and Human Services Department is negotiating to buy drugs to treat radiation sickness, the ailment facing those affected by the fallout from a nuclear detonation, according to two drug manufacturers. But that program has been beset by delays and questions, eliciting complaints from industry and ire from Capitol Hill. "I remain extremely concerned about the nation's preparedness for a nuclear event on United States soil," wrote Rep. Tom Davis, R-Va., chairman of the House Government Reform Committee, in a May 22 letter to HHS Secretary Michael Leavitt. "As you know, I have repeatedly asked your department to provide the committee with updates regarding the [radiation treatment] procurement."
Davis spokesman Rob White said in July that the committee had not received an answer, "nor been told when we might expect one."
The detonation of a 10-kiloton improvised nuclear device near a major metropolitan center is the first catastrophic scenario in a 2005 planning document prepared by the Homeland Security Department for federal, state and local preparedness activities. It predicts hundreds of thousands of casualties. A 2004 report in the Annals of Internal Medicine concluded setting off such a device near a city of 2 million people would kill more than 13,000 immediately, and fallout would leave more than 300,000 others in need of medical care.
For those not killed immediately, the high doses of radiation can cause a collection of illnesses known by the umbrella term radiation sickness, or more formally, acute radiation syndrome. Among the most serious results are the loss of infection-fighting white blood cells, oxygen-carrying red blood cells and blood-clotting platelets; without enough of these cells, victims are left vulnerable to infection, anemia or bleeding to death.
Hollis-Eden Pharmaceuticals of San Diego and Novelos Therapeutics of Newton, Mass., announced in June the drugs they are developing to treat ARS had been judged by Health and Human Services as "within competitive range" for further discussion, a determination that formally begins the procurement process. The products would be injected subcutaneously, so victims could self-administer them much as diabetics take insulin.
But the road to procuring a countermeasure to ARS has been a long one. HHS first solicited such a drug from industry in an October 2004 request for information. Then came a draft version of the request for proposals-initially promised in July 2005, then pushed back to September 2005. The department released the final solicitation in December 2005, and the contract award, originally slated for June, now is promised for September, according to Hollis-Eden and Novelos. HHS officials have not acknowledged the negotiations or spoken publicly about when the award will occur.
"It's safe to say we have concerns about the speed and attention HHS is giving to this important matter," says Davis spokesman White.
Davis and others have asked why HHS' solicitation asks for up to 100,000 doses of the ARS countermeasure, with the potential for an additional 100,000 doses later, when a nuclear attack in a major U.S. city likely would affect far more than 200,000 people. By comparison, HHS bought 1.7 million pediatric doses of a drug to prevent the thyroid gland from absorbing too much radioactive iodine and 400,000 doses of two agents that can help expel certain kinds of (non-nuclear) radiation from the body. Those drugs would not treat radiation sickness.
"A hundred thousand doses is not nearly enough," Lee Hamilton, vice chairman of the 9/11 commission, told 60 Minutes in January. "If you really had a major attack, you probably would need much more than that. One estimate we made was that we'd need 10 million doses."
And industry representatives say the 100,000 figure is harmful because it discourages investment in drugs to treat radiation victims. The point of Project BioShield, the $5.6 billion federal biodefense program that will fund the procurement, is to establish the market for certain countermeasures so that investors, seeing the potential reward, will fund the costly and risky drug development.
"They're saying to the world 'There is no market for development of any radiation protector,' " says one researcher in the field, who asked not to be named to avoid souring relations with the department. "Unless you're making Rolls-Royces, what are you going to sell 100,000 doses of and make it commercial?"
Last fall, HHS itself funded $47 million in grants and contracts for research on countermeasures to radiological and nuclear threats, through the National Institutes of Health. But some in the scientific community say the program excludes many experts in nuclear radiation and its research is more relevant to cancer patients, who could receive higher levels of cancer-fighting therapy if the harmful effects of radiation were reduced. Most universities and institutes tapped to become the Centers for Medical Countermeasures Against Radiation under the NIH program are radiation oncology programs.
Scott Miller, chief of the University of Utah's division of radiobiology, says the NIH-funded research is "fantastic" for radiation oncology, but does not deal with the components of nuclear fuel or a nuclear warhead. "The programs selected for CMCR funding have most of their experience in the sterile environment of radiation oncology programs in hospitals where only certain types of radiation are used and under very controlled situations," Miller says via e-mail. "Additionally, some of the products that are being developed are only effective given prior to radiation exposure. This is wonderful in a hospital setting, but not very practical in a radiological attack."
The Hollis-Eden and Novelos products would be given after an attack. Both companies are pleased that HHS might buy some. "We truly believe if we get validated and win this award, the technology gets validated and we can expand into a much bigger number-either in the private sector or in the government itself," says Hollis-Eden senior vice president Robert Marsella.