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NAS/IOM Report
The following press release may be of interest.
******************************
FEDERAL AUTHORITY OVER MEDICAL USE OF
NUCLEAR BYPRODUCTS SHOULD BE
TRANSFERRED TO STATES
News from the Institute of Medicine
Office of News and Public Information
2101 Constitution Avenue, N.W.,
Washington, D.C. 20418
(202) 334-2138
Date: Dec. 14, 1995
Contacts:Dan Quinn, Media Relations Associate; Dove Coggeshall, Media Relations
Assistant
Telephone: (202) 334-2138
E-mail: news@nas.edu
WASHINGTON -- Congress should remove the U.S. Nuclear Regulatory
Commission's
(USNRC) authority to regulate the medical use of nuclear reactor
byproducts, to bring
about a more uniform, streamlined, and cost-effective approach to
regulation of all ionizing
radiation in medicine, an Institute of Medicine (IOM) committee has
recommended in a
new report.*
Instead, the states -- with the oversight and support of the U.S.
Department of Health and
Human Services (DHHS) -- should expand their existing radiation safety
control programs
to include the regulation of nuclear reactor byproduct materials, which
constitute
approximately 10 percent of all ionizing radiation used in medicine.
These byproduct
materials are used to diagnose cancer and other diseases and in cancer
therapy. Currently
all other forms of ionizing radiation used in medicine are regulated by
the states, including
the use of X-ray machines and particle accelerators.
"The USNRC has provided a safe environment for patients and
administrators," said
committee chair Charles E. Putman, professor of radiology and medicine
and senior vice
president, Duke University, Durham, N.C. "However, states have shown the
same ability
to protect patient safety in regulating the use of radiation. This
option would sustain the
high level of patient and worker safety, reduce duplicative regulation,
and foster a better
allocation of resources."
Giving regulatory authority to the states would adequately protect
health and would be less
intrusive and costly for the facilities being regulated while preserving
access to the
tremendous benefits of these procedures, the committee said.
The study was requested by the USNRC following Senate hearings that
investigated the
1992 death of a cancer patient in Indiana, Pa., who had received a
lethal dose of ionizing
radiation. "Such adverse events have the capacity . . . to overshadow
the millions of
success stories that result from radiation," the IOM committee said.
"The number of
favorable outcomes from radiation therapy far exceeds the number of
problematic
outcomes."
Although the committee did not take issue with the USNRC's ability to
ensure safety, it
did find fault with the degree to which the agency's regulations hinder
efficiency and
intrude in the practice of medicine. The USNRC's present set of
regulations and its
approach to enforcement are excessive and unduly prescriptive, the
committee said. Left
unchanged, the agency's rising fees and duplicative regulations could
force some medical
facilities to forego offering procedures that use byproduct material.
"Fewer people will
benefit if regulation makes radiation medicine needlessly expensive or
less accessible to
patients because fewer institutions can afford to offer [these
procedures]," the report says.
Regulations should be eliminated that result in added costs, but achieve
little reduction in
risk or added benefit for a patient's outcome or the well-being of
health care personnel.
Federal agencies would retain their responsibilities for the approval of
radiopharmaceuticals; the oversight of the generation, transport,
non-medical use and
disposal of radionuclides; and the certification or approval of
equipment that generates
ionizing radiation, the report says.
The USNRC currently licenses more than 2,000 facilities. It authorizes
physician users,
develops safety regulations, sets criteria for determining when and how
byproducts may
have been misadministered, conducts compliance inspections, and assesses
and collects
fees and fines.
The transfer of authority from the USNRC to the states should occur only
after the
secretary of health and human services has put in place a system to
assist the states in
setting up their own enforcement mechanisms. DHHS also should monitor
the effects of
deregulation, enhance training and standards for health care personnel,
and investigate
future problems regarding radiation medicine.
The transition to state regulatory authority would be facilitated by the
existing set of state
regulations promulgated by the Council of Radiation Control Program
Directors
(CRCPD). The committee recommended that DHHS work with CRCPD and other
professional organizations to provide ongoing guidance to the states.
As an interim measure, the USNRC should immediately relax its method of
enforcing
regulations of byproducts materials, and take steps to foster a more
cooperative approach
to working with regulated institutions, the committee said.
With one exception, the committee endorsed all of the findings and
recommendations in
the report. Committee member Robert S. Adler, professor of legal
studies, University of
North Carolina, Chapel Hill, said in a separate statement in the report
that reform, not
repeal, of federal authority over nuclear medicine would be the best way
to ensure public
safety.
The study was funded by the Nuclear Regulatory Commission. A committee
roster
follows. The Institute of Medicine is a private, non-profit organization
that provides health
policy advice under a congressional charter granted to the National
Academy of Sciences.
*Pre-publication copies of the report, Radiation in Medicine: A Need for
Regulatory Reform are available from the National Academy Press at the
mailing
address in the letterhead; tel. (202) 334-3313 or 1-800-624-6242.
Reporters may obtain
copies from the Office of News and Public Information at the letterhead
address (contacts
listed above).
Internet availability: This publication announcement is available on the World
Wide Web at
http://www.nas.edu; via Gopher at gopher.nas.edu; and via FTP at
ftp.nas.edu/pub/
Institute Of Medicine
Division of Health Care Services
Committee for Review and Evaluation of the
Medical Use Program of the Nuclear Regulatory
Commission
Charles E. Putman, M.D.* (chair)
James B. Duke Professor of Radiology;
Professor of Medicine; and
Senior Vice President, Research Administration and Policy
Duke University, Durham, N.C.
Robert S. Adler, J.D.
Professor of Legal Studies and
Associate Dean of Undergraduate Program
Kenan-Flagler School of Business
University of North Carolina, Chapel Hill
Byron William Brown Jr., Ph.D.*
Professor and Chair, Department of Health Research and Policy
Stanford University
Stanford, Calif.
Jennifer D. Bucholtz, R.N., M.S., O.C.N.
Adjunct Faculty, Department of Advanced Nursing Science
University of Delaware, Newark; and
Associate Faculty Member
Johns Hopkins School of Nursing, and
Clinical Nurse Specialist in Radiation Oncology
Johns Hopkins Oncology Center, Baltimore
Timothy Conlan, Ph.D.
Associate Professor, Department of Public and International Affairs
George Mason University, Fairfax, Va.
Barbara Y. Croft, Ph.D.
Associate Professor of Radiology, Department of Radiology
University of Virginia, Charlottesville
Sister Rosemary Donley, S.C.*
Executive Vice President
The Catholic University of America
Washington, D.C.
David S. Gooden, J.D., Ph.D.
Director, Department of Biomedical Physics
St. Francis Hospital, Tulsa
Chair, Radiation Advisory Council
Oklahoma Department of Environmental Quality
Oklahoma City
William Hendee, Ph.D.
Senior Associate Dean for Research;
Vice President for Technology; Dean of Graduate School;
Professor of Radiology, Radiation, Oncology, Biophysics, and Bioethics; and
Director, Health Information Technology Center
Medical College of Wisconsin, Milwaukee
David E. Kuhl, M.D.*
Professor of Internal Medicine and Radiology, and
Chief, Division of Nuclear Medicine
Department of Internal Medicine
University of Michigan Medical Center
Ann Arbor
Lester Lave, Ph.D.*
University Professor, Graduate School of Industrial Administration;
Harry B. and James H. Higgins Professor of Economics and Finance;
Professor of Engineering and Public Policy, Engineering School; and
Professor of Urban and Public Affairs, Heinz School of Public Policy
Carnegie-Mellon University, Pittsburgh
Theodore L. Phillips, M.D.*
Professor and Chair, Department of Radiation Oncology
University of California, San Francisco
Marcia O. Stevic, Ph.D., R.N.
Health Outcomes Researcher
Health Services Advisory Group
Phoenix
John Villforth
President
The Food and Drug Law Institute Inc.
Washington, D.C.
J. Frank Wilson, M.D., F.A.C.R.
Professor and Chair, Department of Radiation Oncology
Medical College of Wisconsin, Milwaukee
Barry L. Zaret, Ph.D.
Robert W. Berliner Professor of Medicine;
Professor of Diagnostic Radiology;
Chief, Section of Cardiovascular Medicine; and
Associate Chair for Clinical Affairs
Department of Internal Medicine
Yale University School of Medicine
New Haven, Conn.
RESEARCH COUNCIL STAFF
Kate-Louise D. Gottfried, J.D., M.S.P.H.
Study Director
* Member, Institute of Medicine