Appendix AStudy Activities

Publication Details

To undertake this study, the IOM and the NRC established two committees (see rosters at the front of this report and the Committee Biographies). In its request to the IOM and the NRC, the NCI asked that the work of the Institute of Medicine and the National Research Council be conducted in public to the fullest extent possible. Consistent with the policies of the National Academy of Sciences, the committees conducted their fact-finding activities in public meetings and met in closed session only to consider findings and recommendations. The committees sought to hold as many open sessions as was consistent with its resources, charge, and Academy policy. At their first meetings in December 1997, both committees examined their composition to make certain that necessary expertise and perspectives were represented, and no significant conflicts of interest or bias existed. Those members of the committee who could not be present participated through a conference call.

The IOM Committee on Guidelines for Thyroid Cancer Screening after Exposure to Radioactive Iodine Fallout was appointed to focus on clinical and public health issues and policies. It included experts in preventive services, thyroid cancer diagnosis and management, medical decision-making, practice guideline development and implementation, and public health policy. The IOM committee met three times—in December 1997, March 1998, and April 1998. The first meeting on December 20 was a three-hour, closed organizing session. For the second meeting, the committee organized a March 17-18 workshop on thyroid cancer screening in which the NRC committee members also participated (see the end of this appendix for the agenda). At a closed one-day meeting on April 11, the committee reached final agreement on its conclusions and recommendations.

The NRC Committee on Exposure of the American People to I-131 from the Nevada Atomic Bomb Tests included people with expertise in thyroid disease, epidemiology, risk assessment, radiobiology, dose reconstruction, health physics, public health, risk communication, clinical practice, and medical ethics. The majority of this group, which focused on the first five tasks listed above, were already serving on the NRC Committee on an Assessment of CDC Radiation Studies and had accumulated considerable experience in dose reconstruction in the course of its work for the Centers for Disease Control and Prevention (CDC). Four individuals served on both committees.

The NRC committee met five times—in December 1997, January 1998, February 1998 (two meetings), and March 1998. In an open session December 19, the NRC committee and observers received some six hours of detailed briefings on the National Cancer Institute Report by the investigators. This began with an Introduction and Overview of the Study by Dr. Bruce Wachholz, and was followed by presentations on the “Estimation of the Activities of I-131 Deposited on the Ground” by Drs. Harold Beck and Lester Machta, on the “Transfer of I-131 from Deposition on the Ground to Fresh Cows' Milk” by Mr. Paul Voillequé and Drs. Mona Dreicer and André Bouville, on “Milk Production, Utilization, Distribution and Consumption” by Dr. Mona Dreicer, on “Dose Conversion Factors” by Dr. Jacob Robbins, on “Dose Reconstruction Methodology” by Dr. André Bouville, and finally on the “Estimated Thyroid Doses” by Drs. Lester Machta and Bruce Wachholz. These presentations were followed by a brief description of the methods employed to assess the risks of thyroid cancer resulting from the estimates of thyroid dose by Dr. Charles Land (see Appendix B). It should be noted that the estimates of the lifetime risk of thyroid cancer and the possible number of individuals so affected are not included in the two volume report but were provided to the committee in the form of a memorandum addressed to Dr. Richard Klausner, the Director of the National Cancer Institute, and subsequently a revised version as a communication to the committee. The questions raised by the committee centered on the reconstruction of the doses, and in particular, the use of kriging to estimate county values where direct measurements were not available, on the methods used to determine the uncertainties in the estimates of dose, and on the assumptions inherent in the estimates of the lifetime risk of thyroid cancer.

This briefing was followed by statements from Drs. Lynn Anspaugh, Donald Myers, Roy Shore, and F. Owen Hoffman, who performed supporting experimental research at Oak Ridge National Laboratory during the mid 1980s. Given the idiosyncratic nature of dose reconstructions, these four consultants to the committee were asked to present their views on the dosimetry and dose reconstruction used in the report, the risk factors developed by the investigators and epidemiological considerations for thyroid disease, and the appropriateness of the use of spatial interpolation and kriging to assign putative exposures where no direct measurements were available. Parenthetically, kriging is an algorithm for estimating the value of a spatially distributed variable from adjacent values while considering their interdependence. These presentations were followed by statements from the public including a prepared statement from Mr. E. Cooper Brown of the law firm of Cummins and Brown on the need for openness of all committee sessions.

On the second day of the NRC committee meeting, Dr. F. Owen Hoffman identified several issues relevant to the committee's charge that needed further discussion, and members of the IOM Committee on Thyroid Screening Related to I-131 Exposure, specifically Drs. Robert Lawrence and Steven Pauker, and co-study director Marilyn Field, discussed the approach being taken by the IOM in consideration of clinical and public health policies related to iodine-131 exposure and the risk of thyroid cancer. The NRC committee then grappled with the proposed structure of its report and the designation of writing assignments.

The second meeting of the NRC committee was held at the National Academy of Sciences' Beckman Center in Irvine, California on January 16-17, 1998. There the committee continued discussion of the charge, the structure of the report, and fact-finding. The first day of this meeting was in open session, and included three conference calls. The first of these involved Dr. Paul Gilman of the National Research Council's Commission on Life Sciences and dealt with the Academy's position and its legal obligations with respect to the issue of the openness of the committee's deliberations. The second was to Dr. Carl A. Gogolak of the Environmental Measurements Laboratory of the Department of Energy from whom the committee sought more information on how the kriging had been applied. Finally, the third was to Drs. Elaine Ron of the Radiation Epidemiology Branch of the National Cancer Institute and Jay A. Lubin of the Biostatistics Branch of the same institute who provided further information on the study they published in 1995 utilizing the data from some seven studies of the health effects of exposure to I-131. Their help was requested in further analyses of these data. This day's activities ended with presentations from three members of the public: Mr. James P. Thomas of Short, Cressman & Burgess, Attorneys-at-Law, in Seattle, Mr. Fred Allingham, Administrative Director of the National Association of Radiation Survivors, and Mrs. Kymberlee Burnell, a psychotherapist who spoke on her own behalf.

The second day focused on continued discussion of the structure of the report, and how best to integrate the work of the IOM committee investigating clinical and public health policies and the results to emerge from the Workshop on Thyroid Cancer Screening and Health Implications of Exposure to Radioactive Iodine Fallout to be held in Washington, D.C. on March 17-19, 1998. The meeting ended after agreement was reached on the dates of the next three committee meetings and further writing assignments were made.

The third meeting of the NRC committee occurred on February 10th and 11th, 1998, at the National Academy of Sciences in Washington. The first of these two days involved closed discussion of the report, and identification of areas where further fact-finding was indicated. The second day was open and attended by the committee's consultants as well as representatives of the public and other federal agencies whose activities impinge on the charge before the committee. Presentations were made by Dr. John Bagby, Mr. Tim Connor, and Ms. Trisha Pritikin, representing the Advisory Committee on Energy Related Epidemiological Research (ACERER) of CDC's National Center on Environmental Health (NCEH) and the National Institute of Occupational Safety and Health (NIOSH), by Dr. Robert Spengler of the Division of Health Studies of the Agency for Toxic Substances and Disease Registry (ATSDR), by Dr. Kenneth Kopecky of the Fred Hutchinson Cancer Research Center and one of the principal investigators in the Hanford Thyroid Disease Study, by Mr. Seth Tuler of the Center for Technology, Environment and Development (CENTED) of Clark University, and by Mr. James Thomas of Short, Cressman and Burgess, Attorneys-at-Law, in Seattle.

The fourth meeting of the NRC committee occurred on February 27th and 28th in Las Vegas, Nevada. On the first of these days the committee continued to develop its report and to explore alternative ways and language to respond to its charge. The second day of the meeting was open to the public and centered on discussion of the ways in which the risks and the public health consequences could best be communicated to the public. Some 14 members of the public or representatives of concerned groups were present and most participated in the discussion. To maximize interaction, the members of the committee discussed the charge before them, the nature of the National Research Council and its committee activities, and the time constraints under which the committee is operating. To further public understanding of the findings of the National Cancer Institute, these findings and those of the ORERP Study as well as the dose reconstruction methods they employed were contrasted by Dr. Lynn Anspaugh. In addition, on behalf of the committee, Drs. Keith Baverstock, F. Owen Hoffman, and Henry Royal presented a series of alternative ways in which risk might be presented for public reaction. Responses to these alternatives were made by Ms. Trisha Pritikin of ACERER, Mr. Richard A. Nielsen, Executive Director of Citizen Alert, and others.

As a possible paradigm for the NRC committee's recommendations to the Secretary of the Department of Health and Human Services, Ms. Bea Kelleigh, the Executive Director, Cedar River Associates, under contract with the Hanford Health Information Network to develop public information, described at some length the steps that have been and are being taken by the Hanford Health Information Network to inform the public of the findings of the studies associated with the Hanford Nuclear Facility and their public health implications.

On March 17, the committee met briefly in closed session in advance of the workshop organized by the IOM committee considering the clinical and public health policy implications of iodine-131 exposure and thyroid cancer risk. The workshop agenda and participants list is provided below.

WORKSHOP ON THYROID CANCER SCREENING AND HEALTH IMPLICATIONS OF EXPOSURE TO RADIOACTIVE IODINE FALLOUT

March 17-18, 1998 • Washington D.C.

AGENDA

TUESDAY, MARCH 17 LECTURE ROOM, 2101 Constitution Avenue NW

WEDNESDAY, MARCH 18 MEMBERS ROOM, 2101 Constitution Avenue NW

WORKSHOP PARTICIPANTS LIST

Keith F. Baverstock, Ph.D.

Head of the Radiation Protection Division

World Health Organization

David V. Becker, M.D.

Professor of Radiology and Nuclear Medicine

New York Hospital

Clyde Behney

Deputy Executive Officer

Institute of Medicine/National Academy of Sciences

Stephen A. Benjamin, Ph.D.

Professor of Pathology, Radiological Health Sciences and Environmental Health

Colorado State University

Catherine Borbas, Ph.D.

Executive Director

Healthcare Education and Research Foundation, Inc.

A. Bertrand Brill, M.D., Ph.D.

Professor of Radiology/Physics, Biomedical Engineering

Vanderbilt University Medical Center

J. William Charboneau, M.D.

Professor of Radiology

Mayo Clinic and Mayo Medical School

Evan B. Douple, Ph.D.

Director, Board on Radiation Effects Research

National Research Council

Sharon Dunwoody, Ph.D.

Evjue-Bascom Professor of Journalism and Mass Communication, Head of Academic Programs, Institute for Environmental Studies

University of Wisconsin-Madison

Karen Beekman Eden, Ph.D.

Assistant Professor

Oregon Health Sciences University

Marilyn J. Field, Ph.D.

Co-study Director, I-131 report

Deputy Director of Health Care Services

Institute of Medicine

Kristine M. Gebbie, Dr.P.H., R.N.

Assistant Professor, Center for Health Policy and Health Services Research

Columbia University School of Nursing

H. Jack Geiger, M.D.

Arthur C. Logan Professor Emeritus, Dept. of Community Health and Social Medicine

City University of New York Medical School

Paul Gilman, Ph.D.

Executive Director

Commission on Life Sciences

National Research Council/National Academy of Sciences

Peter G. Groer, Ph.D.

Associate Professor

University of Tennessee

Department of Nuclear Engineering

Michael F. Hartshorne, M.D.

Professor and Vice Chairman of Radiology

University of New Mexico and Joint Imaging Service VAMC Albuquerque

Karen Hein, Ph.D.

Executive Officer

Institute of Medicine/National Academy of Sciences

Mark Helfand, M.D.

Assistant Professor, Division of Medical Informatics and Outcomes Research

Oregon Health Sciences University

Allan Korn, M.D.

Vice President and Medical Director

Blue Cross and Blue Shield of Illinois

Paul Ladenson, M.D.

Director of the Division of Endocrinology and Metabolism

Johns Hopkins University School of Medicine

Susan Lederer, Ph.D.

Associate Professor of Humanities

Pennsylvania State University

Laura Leonard

Project Coordinator, Hanford Health Information Network

Oregon Health Division

Virginia A. LiVolsi, M.D.

Vice Chair for Anatomic Pathology

Hospital of the University of Pennsylvania

James E. Martin, Ph.D.

Associate Professor of Radiological Health

University of Michigan

Ernest L. Mazzaferri, M.D.

Professor and Chair, Department of Internal Medicine

Ohio State University

Kathryn Merriam, Ph.D.

Synthesis, Inc.

Matthew D. Mitchell, Ph.D.

Technology Analyst

ECRI, Inc.

Christopher B. Nelson, B.S.

Environmental Engineer

Environmental Protection Agency

Stephen G. Pauker, M.D.

Vice Chair for Clinical Affairs

New England Medical Center

Department of Medicine

Morton Rabinowitz, M.D.

Media, Pennsylvania

David Ransohoff, M.D.

Professor

University of North Carolina, Chapel Hill

Richard Reingans, Ph.D.

Health Economist

Agency for Toxic Substances and Disease Registry

Jacob Robbins, M.D.

Senior Scientist Emeritus, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institutes of Health

Henry D. Royal, M.D.

Associate Director, Division of Nuclear Medicine

Mallinckrodt Institute of Radiology

Arthur B. Schneider, M.D., Ph.D.

Section Chief, Department of Endocrinology-M/C 640

University of Illinois at Chicago

William J. Schull, Ph.D.

Chairman

Center for Demographic and Population Genetics

School of Public Health

University of Texas

Richard H. Schultz, M.S.

Administrator

State of Idaho

State Division of Health

Department of Health and Welfare

Lisa Schwartz, M.D.

Assistant Professor of Medicine

Dartmouth Medical School

Roy Shore, Ph.D.

Professor, Environmental Medicine

New York University Medical Center

Laboratory of Epidemiology and Biostatistics

Steven L. Simon, Ph.D.

Co-study Director, I-131 report

Senior Staff Officer

National Research Council

James Smith, Ph.D.

Chief of Radiation Studies Branch, Division of Environmental Hazards and Health Effects

Centers for Disease Control and Prevention

Harold C. Sox, M.D.

Professor and Chair

Dartmouth-Hitchcock Medical Center

One Medical Center Drive

Robert F. Spengler, Sc.D.

Division of Health Studies

Agency for Toxic Substances and Disease Registry

Michael Stoto, Ph.D.

Senior Program Officer, Division of Health Promotion and Disease Prevention

Institute of Medicine/National Academy of Sciences

Daniel O. Stram, Ph.D.

Associate Professor

University of Southern California

Department of Preventive Medicine

Robert G. Thomas, PhD

Kallispell, MT

Robert S. Thompson, M.D.

Director, Department of Preventive Care

Group Health Cooperative of Puget Sound

Charles M. Turkelson, Ph.D.

Chief Research Analyst

ECRI

R. Michael Tuttle, M.D.

Assistant Chief, Department of Clinical Investigation; Chief, Clinical Studies Service

Walter Reed Army Medical Center

Samuel A. Wells, M.D.

Professor of Surgery

Washington University School of Medicine

Steven Woloshin, M.D.

Assistant Professor of Medicine

Dartmouth Medical School

Steven H. Woolf, M.D., M.P.H.

Professor, Department of Family Practice

Virginia Commonwealth University

Medical College of Virginia