HHS KI Guidance Response Letter

December 15, 2004

Robert G. Claypool, M.D.
Deputy Chief Medical Officer
Office of Public Health Emergency Preparedness
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Re: DHHS Draft Guideline on Potassium Iodide (KI)

Dear Dr. Claypool:

The Public Health Committee of the American Thyroid Association has reviewed the draft version of the DHHS document titled “Federal Guidelines for Requesting Potassium Iodide (KI) from the Strategic National Stockpile.” We understand that DHHS staff is prepared to consider comments on the contents of this draft document from interested parties. As professionals dedicated to promoting thyroid health, therefore, we offer the following criticisms of this important document, with the hope that it will be significantly revised and improved.

First, the rationale for KI use is not sufficiently emphasized in the document. KI prevents thyroid cancers arising in individuals exposed to the radioactive iodine that can be released in a nuclear reactor incident, such as might be caused by terrorist action. Experience from the radioactive iodine exposure resulting from the Chornobyl accident demonstrates that thyroid cancer incidence rises substantially in unprotected populations, particularly children and young adults. Populations with an effective plan for KI stockpiling and expeditious distribution and use would have a very significantly lower risk of developing thyroid cancer secondary to radioactive iodine exposure. Consequently, it is disappointing that thyroid cancer prevention, the central reason for KI use, is not mentioned in the document until page 7.

Second, the draft guideline addresses only the issue of stockpiling of KI. Under Section 127 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, federal guidelines were to be established for the stockpiling, distribution, and use of KI tablets in the event of a nuclear incident. The present document does not address local distribution planning despite the Bioterrorism Act’s requirement that DHHS support localities in developing such plans. 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 in section IV, “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. The facts that both an expert committee of the National Academy of Sciences and the American Thyroid Association endorse the use of KI and have confidence in its safety are not mentioned. On the contrary, the current draft exaggerates the demonstrated low level risks associated with KI use. Adverse reactions were shown to be extremely rare in the Polish experience after the Chornobyl accident.

Fourth, sections IV and V establish onerous requirements for requesting KI from the National Stockpile. These would interfere, rather than assist and encourage states and localities to obtain KI and provide for its use in an emergency. Although evacuation, sheltering, and restricting access to contaminated milk and food are important safety measures, KI is an essential supplement to these measures to maximize public safety.

We strongly urge DHHS to rethink and revise these draft guidelines in consultation with both appropriate local agencies, as called for by the Bioterrorism Act, and knowledgeable professional organizations, such as the NAS and 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.

We look forward to your reply and stand prepared to assist DHHS in preparing a more appropriate set of guidelines for KI stockpiling, distribution, and use.

Sincerely,

Paul W. Ladenson, M.D.
ATA President

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