pediatric liquid potassium iodide (KI)

HHS Awards Bioshield Contract for Liquid Potassium Iodide: The Department of Health and Human Services today awarded a $5.7 million contract to Fleming & Company, Pharmaceuticals of Fenton, Mo. for the manufacture and delivery of 1.7 million pediatric doses of liquid potassium iodide (KI). This supply of liquid KI, which is being purchased under the BioShield program, would be used in the event of a release of radioactive iodine, a commonly produced material in commercial nuclear power facilities.

The liquid KI formulation is the first to be developed specifically for children. Its black raspberry taste is designed to make it more palatable to children. Current adult dose tablets are bitter and must be broken into pieces to get a child's dose. The new formulation is delivered using a graduated eyedropper.

"The acquisition of this new and easy-to-administer pediatric KI formulation is an important step forward for our nation's radiological preparedness program," Assistant Secretary for Public Health Emergency Preparedness Stewart Simonson, said.

Because the thyroid gland rapidly absorbs any iodine in the body, people need to take KI soon after an incident that involves the release of radioactive iodine, such as could occur in the vicinity of a nuclear commercial power facility. The KI saturates the thyroid gland with iodine, thus preventing the thyroid from absorbing additional, radioactive iodine. However, KI does not prevent the effects of any other radioactive elements.

Approval of the liquid KI as a pediatric formulation was given last year by the Interagency Weapons of Mass Destruction Medical Countermeasures Subcommittee. Children are the most susceptible to the dangerous effects of radioactive iodine.

Once it is delivered to HHS, the pediatric KI will be made available to states that submit and receive approval from HHS for plans they develop to distribute the new product in communities around commercial nuclear power plants.

The Food and Drug Administration (FDA) has approved KI in tablet form as a nonprescription drug for use as a "blocking agent" to prevent the human thyroid gland from absorbing radioactive iodine. On Jan. 12, 2005, the FDA granted approval to Fleming for their product ThyroShieldTM (Potassium Iodide Oral Solution, USP) 65 mg/ml for children.


### FOR IMMEDIATE RELEASE Friday, March 18, 2005 HHS Press Office (202) 690-6343

SOURCE: United States Department of Health and Human Services

Yucca Mountain project, US Geological Survey (USGS)

Statement From Secretary of Energy, Samuel Bodman

WASHINGTON, DC -- The Department of Energy has learned that certain employees of the US Geological Survey (USGS) at the Department of the Interior working on the Yucca Mountain project may have falsified documentation of their work. This documentation is required as part of the Department of Energy and Nuclear Regulatory Commission’s quality assurance programs that verify the accuracy and credibility of work that has been completed. This documentation in question relates to computer modeling involving water infiltration and climate.

“During the document review process associated with the Licensing Support Network preparation for the Yucca Mountain project, DOE contractors discovered multiple emails written between May 1998 and March 2000, in which a USGS employee indicated that he had fabricated documentation of his work.

“The Department of Energy has initiated a scientific investigation of the data and documentation that was part of this modeling activity. If in the course of that review any work is found to be deficient, it will be replaced or supplemented with analysis and documentation that meets appropriate quality assurance standards to ensure that the scientific basis of the project is sound. We are conducting a thorough review of all work completed by the identified individuals to ensure that other work was not affected.

“Additionally, we have informed the US Geological Survey and the State of Nevada. We have initiated an evaluation to determine if the systematic quality assurance improvements undertaken over the last four years are sufficient to prevent the reoccurrence of a similar situation. And we plan to reemphasize to project personnel the importance of strict adherence to quality assurance procedures.

“I am greatly disturbed by the possibility that any of the work related to the Yucca Mountain Project may have been falsified. This behavior indicated in the emails is completely unacceptable, and I have referred this matter to the Department of Energy’s Office of Inspector General for full investigation.

“The safe handling and disposal of nuclear waste and the sound scientific basis for the repository safety analysis are priorities for this Administration and the Department of Energy. All related decisions have been, and will continue to be, based on sound science.

“The fact remains that this country needs a permanent geological nuclear waste repository, and the Administration will continue to aggressively pursue that goal. We are committed to the safety and protection of the citizens of Nevada as we pursue the development of the Yucca Mountain project.”

Media contact: Anne Womack-Kolton, 202/586-4940 Number: R-05-054 March 16, 2005 SOURCE: department of energy