ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS


                          Minutes: July 25-26.


                              July 25, 1994

Attending: Ruth Faden, Eli Glatstein, Jay Katz, Pat King, Susan
Lederer, Ruth Macklin,   Lois Norris, Nancy Oleinick, Henry
Royal, Philip Russell, Mary Ann Stevenson,   Reed Tuckson. 


     Philip Caplan, Special Assistant to the President for
Cabinet Affairs, opened the meeting in the Council Room of the
Mayflower Hotel, 1127 Connecticut Avenue, NW, Washington, D.C.
Dr. Faden briefed members on the plans for the meeting and noted
that there would be a more extensive than usual public comment
session at the end of the first day, because of the number of
public comment requests received.



Briefing: Regulation of Contemporary Radioactive Drug Research.
Barry Siegel.


     Dr. Siegel, director of the Division of Nuclear Medicine at
Mallinckrodt Institute of Radiology and chairman of the Advisory
Committee on Medical Uses of Isotopes of the Nuclear Regulatory
Commission, briefed members on the regulatory regime for isotope
research ushered in by the Atomic Energy Act of 1946 and amended
over the following decades. He traced how Atomic Energy
Commission/Department of Energy regulations were over time
entwined with Food and Drug Administration regulations, and that
many institutional committees oversee uses of radioactive drugs.
Radioactive drugs are adequately regulated, he said.

     Members questioned Dr. Siegel about Institutional Review
Boards and Radioactive Drug Research Committee processes and his
experience with oversight of human subject research at Washington
University.



Briefing: History of Radiation Protection Standards. Gil
Whittemore.


     Dr. Whittemore briefed members on the history of radiation
standards, beginning with medical effects of x-rays and radium.
The difficulties multiplied in the post World War II-era of
vastly greater use of radioisotopes. 

     Members discussed with Dr. Whittemore the great difficulty
of demonstrating genetic effects of radiation exposure;
difficulties of determining risks of increased illness in
statistical terms; and the early concern with the safety of
medical workers.



Briefing: An Epidemiologic Perspective on Low-Dose Radiation
Risks. Duncan Thomas.


     Dr. Thomas briefed members on BEIR V risk estimates, many
derived from epidemiological studies following the bombing of
Hiroshima and Nagasaki. He briefed members on thyroid and
leukemia studies from Nevada Test Site fallout, radon studies of
lung cancer in uranium miners, and studies of leukemia risk from
diagnostic x-rays. Dr. Thomas characterized BEIR V as accepting
carcinogenic effects of low-dose exposures, and he discussed the
implications for compensation of data published since passage of
the Radiation Exposure Compensation Act.

     Members questioned Dr. Thomas about dose reconstruction
problems and inherent statistical uncertainties in fallout
studies.

     

Update: Agency Data Collection Efforts. Ruth Faden. 


     Dr. Faden briefed members on the status of data collection
efforts in government departments and agencies: Health and Human
Services, National Aeronautics and Space Administration, Central
Intelligence Agency, Defense, Energy, Veterans Affairs.

     Dr. Faden said the Committee has received assurances from
the highest levels at the Pentagon that any delays in pursuing
searches will be resolved. The Department of Veterans Affairs
pledged that searches of National Archives records will be
completed in 90 days.

     The Committee is assessing the progress of DoE searches and
working with the department to increase the flow of
documentation. 

     Executive Director Dan Guttman said it is clear that
promising trails exist and can be pursued..



Staff Report: Functional History of Human Radiation Experiments.
Gregg Herken.


     Dr. Herken briefed members on the AEC program of human
subject proposals and its program of regulatory committees. Dr.
Herken said it is becoming clear that AEC oversight was fitful
and that parts of the AEC bureaucracy, as well as AEC
contractors, actively promoted human subject experiments at the
same time that officials at the Division of Biology and Medicine
were discouraging the same.



Staff Report: History of Ethical Policies. Jonathan Moreno.


     Dr. Moreno outlined documentation indicating that concepts
of informed consent existed from the earliest days of human
radiation experiments sponsored by the government. What is not
clear, is the reach of consent policy and practice; for example,
whether they were limited to healthy volunteers, whether they
covered subjects given tracer amounts of radioisotopes within
what were considered safe limits, and whether they covered
activities with therapeutic intent.

     Official ambivalence about human subject rules was
represented by debates among armed service representatives even
the day after Secretary of Defense Wilson's 1953 memorandum on
the Nuremberg Code rules.



Staff Report: History of Government Regulation and Control. Dan
Guttman.

     
     Mr. Guttman briefed members on findings that suggest several
significant questions about the behavior of the government
bureaucracy, including why the Nuremberg Code rules did not
percolate through the chain of command, what role was played by
insurance/legal liability concerns, and what policies or
restraints accounted for varying degrees of debate on human
subject experimentation in different services or government
agencies.

     Members questioned Mr. Guttman on differing conceptions of
voluntariness over time; whether patients correctly appreciated
risks of procedures; differing roles of medical agencies in terms
of priorities, as in the preventive medicine focus of armed
services doctors. In response to questions, Mr. Guttman said the
full role of Shields Warren in preventing or supporting human
subject work by agencies remains to be fully fleshed out. Dr.
Stevenson noted that total-body irradiation work in the 1940s and
1950s may have been driven by limited knowledge of immune system
suppression and the lack of therapeutic alternatives to many
related diseases.



Staff Report: Staff Structure and Current Project Assignments.
Jeffrey Kahn.


     Dr. Kahn introduced new staff member John Harbert and
consultant Nancy Kass. He noted that the Committee staff is
basically at a full complement for the project.

     He briefed members on the reorganization of staff
assignments to reflect priorities and experiment groups approved
by the Committee July 5-6.



Staff Report: Experimental Grouping of Total-Body Irradiation.
Gary Stern, Ron Neumann, Dan Guttman.


     Mr. Stern briefed members on the total-body irradiation that
began prior to the 1940s. Mr. Stern outlined the group of
experiments pursued by researchers with funding participation by
the military and other government agencies. Questions raised
included concerns about secrecy and sponsorship of
experimentation, the level of control exercised by authorities
which had formal ethics policies in place, and design of
experiments to reflect both government purpose and the motivation
of investigators. 

     Dr. Neumann told the Committee about the changing rationales
offered by Dr. Saenger in reports on his work during the 1960s,
with varying emphasis on military/government purpose. 

     Members asked the staff to include more scientific/medical
detail to allow members to assess the experiments, particularly
Dr. Saenger's experiments, in light of a dearth of other
treatment options at the time and the more common use of TBI
therapies in recent years.

     Dr. Royal noted that many government-sponsored projects were
suspect during the Vietnam War era. Dr. Neumann said that
critical judgments by the junior faculty committee at the
University of Cincinnati appear to have been unrelated to that
motivation.

     

Staff Report: Abstraction of "Markey" Experiments. Gil
Whittemore, Jonathan Engel, Dan Guttman.


     Dr. Engel reported that the categorization of experiments is
proceeding but that files, including those developed by other
investigations, often are not complete enough to provide the
depth of subject categories sought by the Committee.

     Mr. Guttman said that the Committee staff needs to dig for
documentation to fill out files to provide members with adequate
data.

               

Public Comment Period


     Stewart Udall, attorney and former U.S. Secretary of the
Interior. Mr. Udall urged the Committee to address the case of
more than 3,000 uranium miners studied by the U.S. Public Health
Service. He said the case should fall within the purview of the
Advisory Committee because of the Public Health Service study and
urged members to address compensation issues in their report.

     Members questioned Mr. Udall about the effectiveness of the
Radiation Exposure Compensation Act and about details of
disclosures or withholding of information about risks to the
miners.

     Eugene Trani, Hermes Kontos, John E. Jones, respectively
president, dean of the School of Medicine, and vice president,
Virginia Commonwealth University. Dr. Trani related the
experience of his university with what he described as press
sensationalism about burn studies at the Medical College of
Virginia, 1949-59. The experiments were neither secret nor
dangerous, and led to significant medical advances, he said,
urging the Committee to make objectivity and balance a keynote in
its report on experiments.

     Dr. Lederer said that her review of some MCV documents
during a visit to Richmond found no evidence to support
interpretations suggested in the June 19 article in The
Washington Post to which Dr. Trani referred. Members of the
Committee briefed Dr. Trani on the work of the Committee and
questioned him about the conduct of the experiments and the
extent of records available at the university; Dr. Russell noted
the extensive benefits of burn studies to trauma victims.

     The Committee asked for additional information about MCV
experiments, including protocols regarding selection of
experiment subjects.

     Chris Zucker, Disability Advocates of New York Inc., Albany,
N.Y. Mr. Zucker urged the Committee to look into ways to improve
protection to those subjects of experimentation not funded by the
federal government, and to subjects incapable of informed consent
because of disabilities.

     Pat Broudy, legislative director, and Oscar Rosen, National
Association of Atomic Veterans. Mrs. Broudy urged the Committee
to include weapons test exposures in its scope for its final
report. She presented documents relating to the exposure of
soldiers at atomic tests.

     Mrs. Catherine Variano of South Bend, Ind. Mrs. Variano
described her extensive medical problems which she ascribed to
radiation treatments as a child. She said the federal government
provided materials for her treatments and should be responsible
for treatment of survivors.

     Members questioned Mrs. Variano about evidence of the
experimental intent of the exposures and whether other persons
were involved. 

     Mrs. Janet Gordon of Citizens Call Utah. Mrs. Gordon
presented a statement from a newly formed Task Force on Radiation
and Human Rights. She urged the Committee to take up the cases of
downwinders from weapons tests, which occasioned experiments of
opportunity in exposed populations, such as the Marshall
Islanders and residents of Washington and Oregon exposed by the
Green Run. She also urged the Committee to add a "victim"
representative to its membership.

     

                              July 26, 1994
                                    


     Dr. Faden called the meeting to order at 9 a.m. in the State
Room of the Mayflower Hotel. The Committee approved the minutes
of the July 5-6 meeting.



Committee Discussion: Interim Report. Dr. Faden.


     Dr. Faden said the Committee's interim report is due to the
Interagency Working Group on Oct. 21. The report is intended to
be a progress report.



Subcommittee Report: Outreach. Stephen Klaidman.


     Dr. Tuckson, chair of the Outreach subcommittee, designated
Mr. Klaidman to speak on his behalf. Mr. Klaidman briefed members
on letters being sent to stakeholder groups to solicit their
input into the Committee's deliberations. The Outreach
subcommittee also met July 25 with leaders of stakeholder
organizations to solicit their help in gathering information and
providing testimony at meetings outside the Washington, D.C.,
area.

     Mr. Klaidman said that the subcommittee is working on
organizing the meeting of the full Committee in San Francisco in
October and up to four panel hearings in cities around the
country.

     Members were asked to provide guidance on the stakeholder
letters drafted by the subcommittee.



Subcommittee Report: Ethics. Dr. Macklin.


     Dr. Lederer briefed members on the oral history segment of
the Ethics subcommittee proposal. A panel of ethicists and
historians is being gathered to advise the Committee on the
project and Committee members were asked to provide names of
potential interviewees.

     Members discussed the criteria for choosing interviewees.

     Drs. Thomas and Oleinick raised the issue of ethical
problems surrounding environmental releases, and the need to
focus on ethical issues, e.g. the role of PHS doctors in the
uranium miners case. Dr. Faden said the Ethics oral history
project is intended to focus narrowly on practices of
investigators. The staff will generate a separate list of
interviews that focus on fact-finding relative to the Cold War
story. Dr. Oleinick noted that environmental releases might be
handled in a very different manner in today's ethical
environment.

     Dr. Faden asked the staff to begin inquiries into today's
ethical attitudes and policy constraints regarding environmental
releases. These inquiries would not necessarily include
interviews.

     Dr. Royal noted that the investigator interviews may result
in very different answers to questions because the interviews are
conducted for a federal commission looking into a highly
controversial topic.

     Dr. Lederer said many interviewees will be eager to see
their firsthand observations in the public record of the
Committee.

     Dr. Macklin asked members to provide ideas and feedback to
Dr. Lederer.

     Ms. Norris expressed concern that subjects' views would not
be solicited in oral histories, which will focus on
investigators. Dr. Faden noted that the Outreach program is
designed to solicit those views and Mr. Guttman reported that the
Committee staff is seeking access to Helpline callers to provide
direct access to persons who contacted the Department of Energy
regarding human radiation experiments.

     Protocol sampling. Drs. Sugarman and Kass made proposals on
the sampling of National Institutes of Health extramural
protocols from fiscal year 1993. Committee members and staff will
determine an appropriate method of sampling. About 100 protocols
will be investigated. Dr. Macklin said that the study appears to
be unprecedented. The Committee will coordinate its efforts to
avoid conflicts with the General Accounting Office and the
National Institutes of Health, which have also expressed interest
in these issues.

     Members discussed the difficulties of getting representative
examples of the most common types of protocols, e.g. radiation
oncology at Health and Human Services, biodistribution at the
Department of Energy. Dr. Faden said that HHS officials are
collaborating closely with the protocol sampling project and will
meet with the staff this week to determine how efficiently the
list can be accessed.

     Dr. Royal noted that an important variable will be the
quality of the work done by Institutional Review Boards at
different institutions. Dr. Macklin noted that the IRB minutes
and consent forms are likely to be gathered in the protocol
study, but Dr. Sugarman said that it will be difficult to assess
how well the IRB process works from the protocol sampling
project. Dr. Faden said that the protocol sampling may suggest
how to approach issues of IRB participation in the process of
approving human experimentation.

     Subject interviews. The Ethics subcommittee presented three
options for interviews with subjects of contemporary research.
Responding to Committee members' concerns at the July 5-6
meeting, Dr. Sugarman said each option is designed to increase
the number of active participants interviewed. Dr. Sugarman said
the projects would require contracting out some of the functions
of the study.

     Members discussed use of focus groups rather than subject
interviews; the number and type of institutions to be surveyed;
logistical difficulties of the study.



Subcommittee Report: Scope and Priorities. Dr. Thomas.

     
     Dr. Thomas briefed members on the Scope subcommittee report
and the continuing process of experiment classification,
enumerating cases the subcommittee believes should be part of the
final report and those that should not be part of the report,
e.g. purely occupational exposures.


     Dr. Thomas said the Scope subcommittee should become dormant
and members should be reassigned to other projects.

     Mr. Guttman said the public will want from the Committee's
work at least an index of identified experiments and the staff
will pursue the data necessary to construct the Committee's
database. Dr. Royal observed that the Committee staff need to
concentrate on filling in gaps in some representative experiments
at an early date, so that the Committee can determine what
experiments or categories will provide sufficient evidence for
the Committee to reach informed conclusions about research
practices, and about how and where to target its resources.

     Dr. Katz suggested that the staff prepare a report for
members outlining options for sampling and fleshing out records
of experiments that are of primary interest to the Committee.
Drs. Faden and Thomas said the experiment sampling paradigm would
be generated from the intensive study of the experiments
identified as of interest to the American people and the
Committee.

     Dr. Macklin said that there must be commensurate criteria to
define Committee conclusions for 1993 protocols and older Cold
War experiments.



Committee Discussion: Restructuring of Subcommittees. Dr. Faden.


     Committee members discussed assigning members to working
groups to focus on particular tasks. Members agreed to the
following working groups, with the provision that roles may
change as the work of the Committee progresses:

     Biomedical Research: Drs. Stevenson and Royal, co-chairs;
Drs. Faden, Glatstein, Oleinick, Russell and Thomas.

     Intentional Releases and Exposures/Experiments of
Opportunity: Drs. Oleinick and Thomas, co-chairs; Drs. Katz and
Macklin and Mr. Feinberg.

     Oral History: Dr. Lederer, chair; Drs. Macklin and Russell.

     Outreach: Dr. Tuckson, chair; Dr. Macklin, Ms. Norris, Dr.
Royal.

     Subject Interviews: Dr. Faden, chair; Dr. Lederer.

     Protocol Review: Drs. Katz and Macklin; Dr. Glatstein, Ms.
Norris and Dr. Royal. Drs. Faden, Stevenson and Thomas were added
to work on the methodology required to launch the study. The
subcommittee was charged with reporting on the methodology phase
of the project at the Committee's September meeting.

     Dr. Faden said that absent m assigning members to working
groups to focus on particular tasks. Members agreed to the
following working groups, with the provision that roles may
change as the work of the Committee progresses:

     Biomedical Research: Drs. Stevenson and Royal, co-chairs;
Drs. Faden, Glatstein, Oleinick, Russell and Thomas.

     Intentional Releases and Exposures/Experiments of
Opportunity: Drs. Oleinick and Thomas, co-chairs; Drs. Katz and
Macklin and Mr. Feinberg.

     Oral History: Dr. Lederer, chair; Drs. Macklin and Russell.

     Outreach: Dr. Tuckson, chair; Dr. Macklin, Ms. Norris, Dr.
Royal.

     Subject Interviews: Dr. Faden, chair; Dr. Lederer.

     Protocol Review: Drs. Katz and Macklin; Dr. Glatstein, Ms.
Norris and Dr. Royal. Drs. Faden, Stevenson and Thomas were added
to work on the methodology required to launch the study. The
subcommittee was charged with reporting on the methodology phase
of the project at the Committee's September meeting.

     Dr. Faden said that absent members (Ms. King, Dr. Tuckson
and Mr. Feinberg) would be consulted about their assignments and
that staff would be named to work on specific projects associated
with the subcommittees.

     The subcommittees on intentional releases and biomedical
research were given oversight responsibility for deciding how
much documentary research will be necessary to elucidate subjects
of interest to the Committee.

     Experiments of opportunity would go to the intentional
release subcommittee. That would include the cases of the uranium
miners, atomic veterans, Marshall Islanders and downwinders, as
well as Green Run and Dugway environmental releases.

     Mr. Caplan closed the meeting at 3 p.m.

     


Appendix A



     Persons signed in to attend all or part of the meeting
included: Oscar Rosen, National Association of Atomic Veterans;
Laura Wilson, Association of American Universities; Tom Smith,
National Association of Radiation Survivors; Patricia Olson,
Senate Veterans Affairs Committee; Martha Glock, National Library
of Medicine; Marcia Haggard; Dennis Nelson, Task Force for
Environmental Awareness; Jackie Kittrell, American Environmental
Health Studies Project; Sandra Reid, Oak Ridge Health Liaison;
Amy Hall, NIH; Gwendon Plair, CROCSP; Joan McCarthy, NCRV/S; Fred
Allingham, NARS; Allan Murray, Embassy of Australia; Chris Kline,
Senate Government Affairs; Heather Shepherd, Congressman
Shepherd's office; Robert de Vesty, Veterans Affairs; Jennifer
Schiller, Daryl Kimball, Physicians for Social Responsibility;
Paul Barton, Gannett News Service; Albert Lukban, Washington
Monthly; Marilyn J. Siegel, Washington University; Rachel Rubey,
Essential Information; Jack Bartley, Lawrence Berkeley
Laboratory; Irene Stith-Coleman, Congressional Research Service;
Janis Stohlar, NASA; Anuj Goel, Congressman Portman's office;
Marty Gensler, Senator Wellstone's office; R. David Thomas Jr.,
Virginia C. Thomas, R.D. Thomas & Co.; Michael Mayes, Office of
Management and Budget; Michael S. Yesley, Los Alamos National
Laboratories; Ed A