FOR IMMEDIATE RELEASE
Dec. 21, 2004
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Health and Human Services Guidelines Mislead and Misinform About Important Role of Potassium Iodide in Nuclear Incident, Say Thyroid Experts
Document is inadequate to help state and local governments protect citizens
(FALLS CHURCH, VA)–Draft guidelines issued by the Department of Health and Human Services (DHHS) to advise state and local governments on stockpiling and distributing potassium iodide (KI) in the event of a nuclear accident or terrorism provide misleading information about the role of KI in preventing negative health effects from radioactive iodine, says the American Thyroid Association (ATA) in a Dec. 15, 2004, letter to Robert G. Claypool, MD, DHHS Deputy Chief Medical Officer. The guidelines interfere with, rather than assist and encourage, states and localities in obtaining KI as a preparedness measure, emphasizes ATA President Paul W. Ladenson, MD.
The guidelines — titled “Federal Guidelines for Requesting Potassium Iodide (KI) from the Strategic National Stockpile” — understate the importance and safety of KI’s role in protecting people from absorbing radioactive iodine released during a nuclear emergency, according to the ATA, which is composed of the leading physicians and scientists who diagnose and treat thyroid diseases.
High levels of radioactive iodine exposure can cause thyroid cancer, especially in babies and children up to 18 years of age. KI reduces the risk of thyroid cancer in exposed populations. The ATA is a strong proponent of KI as an essential part of nuclear disaster preparedness, along with evacuation, sheltering, and avoiding contaminated food, milk, and water.
KI, a nonprescription drug, is the same form of iodine used to iodize table salt. KI works by flooding the thyroid with iodine, thus preventing radioactive iodine from being absorbed. If taken at the proper time, KI protects the thyroid from radioactive iodine from all sources – air, food, milk, and water.
The effectiveness and safety of KI is exemplified in the aftermath of the 1986 Chornobyl nuclear accident, from which shifting winds blew a radioactive cloud throughout the region. As many as 3,000 people exposed to that radiation have already developed thyroid cancer. Most victims had been babies or young children living in Ukraine, Belarus, or Russia at the time of the accident. According to a United Nations report released in February 2002, another 8,000 to 10,000 exposed people may develop thyroid cancer within the next 10 years. Poland, immediately adjacent to Belarus and Ukraine, distributed KI to its citizens and does not appear to have had an increase in thyroid cancer.
In the letter to DHHS, Dr. Ladenson strongly urges the Department to rethink and revise the draft guidelines in consultation with appropriate local agencies, as called for by Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as with knowledgeable professional organizations, such as the National Academy of Sciences and the ATA. “This issue is of the utmost importance if our citizens are to be protected in the event of a nuclear incident arising from terrorism or accident,” emphasizes Dr. Ladenson.
The ATA makes four important criticisms of the document. First, the rationale for KI use is not sufficiently emphasized in the guidelines. Dr. Ladenson points out that experience from the radioactive iodine exposure of the Chornobyl accident demonstrates that thyroid cancer incidence rises substantially in unprotected populations, particularly children and young adults. Furthermore, populations with an effective plan for KI stockpiling and expeditious distribution and use would have a significantly lower risk of developing thyroid cancer secondary to radioactive iodine exposure. The ATA is also disappointed, says Dr. Ladenson, that thyroid cancer prevention, the central reason for KI use, is significantly downplayed.
Second, the draft guidelines address only the issue of stockpiling of KI, he adds. Under Section 127 of the 2002 Bioterrorism Act, federal guidelines were to be established for the stockpiling, distribution, and use of KI tablets in the event of a nuclear incident. Local distribution planning is not addressed in the guidelines despite the Bioterrorism Act’s requirement that DHHS support localities in developing such plans. Dr. Ladenson emphasizes that “It appears that local officials may not have been consulted by DHHS regarding these matters, as required by the act, despite the essential role that they would have in implementing any such plan.”
Third, the demonstrated safety of KI is not emphasized when outlining the considerations of KI use. “The fact that the Food and Drug Administration has vouched for the safety of KI for this specific use is not included in the draft document,” Dr. Ladenson criticizes. Moreover, the DHHS guidelines omit the facts that both an expert committee of the National Academy of Sciences and the ATA endorse the use of KI and have confidence in its safety. “On the contrary,” he points out, “the current draft exaggerates the demonstrated low level risks associated with KI use,” as demonstrated by the extremely rare occurrence of adverse reactions in the Polish population after the Chornobyl accident.
Fourth, DHHS has established onerous requirements for requesting KI from the National Stockpile, which would hinder its use by states and localities in an emergency.
“As professionals dedicated to promoting thyroid health,” Dr. Ladenson implores DHHS to significantly revise and improve its guidelines and offers the ATA’s help in “preparing a more appropriate set of guidelines for KI stockpiling, distribution, and use.”
Founded in 1923, the ATA is a professional society of 900 U.S. and international physicians and scientists who specialize in the research and treatment of thyroid diseases. The Association is dedicated to promoting scientific and public understanding of the biology of the thyroid gland and its disorders, so as to improve methods for their prevention, diagnosis, and management. The ATA fosters excellence in research, patient care, and education of patients, the public, and the medical and scientific communities while guiding public policy about the prevention and management of thyroid diseases.
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HHS KI Guidance Response Letter (December 15, 2004)
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