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Radiation Countermeasure Development Stalls in U.S.
U.S. lawmakers and Hollis-Eden Pharmaceuticals are criticizing the U.S. Health and Human Services Department for its handling of a radiation countermeasure the company has been developing for the five years, the Washington Post reported today (see GSN, July 15). The drug, developed with support from the U.S. Defense Department, is the only anticipated option for treating radiation sickness over the next few years, the company said. Health and Human Services, however, has not moved to procure the drug quickly, despite tests that indicate the product’s effectiveness, the Post reported. Hollis-Eden CEO Richard Hollis told the House Government Reform Committee in July that Project Bioshield — the federal effort to boost development of WMD countermeasures by offering an assured market for the products — suffers from a “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.” Hollis said that few companies are interested in developing Bioshield drugs because of doubts that they would be profitable or even break even. HHS Assistant Secretary Stewart Simonson told the committee that the department was not satisfied with the drug and would draft a request for proposals for another radiation drug by the end of July. The department has yet to release the proposal, according to the Post. The proposal is now set for release this month. The delay was necessary to “insure that the most appropriate immediate targets … can be more fully defined to protect the American public,” said agency spokesman Marc Wolfson. He added that the delay allows the agency to give guidance to the drug industry. National Institute of Allergy and Infectious Diseases Director Anthony Fauci told the committee that “we have to almost start from square one” on producing a radiation sickness drug. He said that the change in threat from a large nuclear attack to a smaller, single detonation or dirty bomb necessitated a different countermeasure. “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.” Radiation sickness is caused by changes to bone marrow, which leads to loss of clotting factors that stop bleeding and cells that fight infections. Hollis-Eden claims its self-injected drug can protect bone marrow. The drug is only effective if taken within four hours of exposure, according to the Post (Marc Kaufman, Washington Post, Sept. 28).
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