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Minute12 { March 15 1995 } Advisory Committee on Human Radiation Experiments
Minutes of Meeting of March 15-17, 1995
Wednesday, March 15, 1995
Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz,
Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy
Oleinick, Henry Royal, Duncan Thomas, Reed Tuckson.
Philip Caplan, Special Assistant to the President for
Cabinet Affairs, officially opened the meeting.
Dr. Faden briefed members on the agenda for the twelfth
meeting of the Advisory Committee.
Approval of Minutes
Members approved without change the minutes of the February
15-17, 1995, meeting of the Advisory Committee.
Public Comment
Ernest Sternglass, Pittsburgh, Pennsylvania. Dr. Sternglass
discussed radiation doses and health effects, particularly what
he called serious health effects of low-dose exposures from
fallout and other intentional releases of radioactivity. He said
the impact of chronic low-dose exposures should be considered in
the Committee s discussion of remedies.
Dr. Sternglass urged that the Committee recommend an
independent reassessment of a 1990 National Cancer Institute
study of radiation dangers to residents of counties surrounding
nuclear production facilities.
Dr. Oleinick questioned Dr. Sternglass about his
correlation of low birth weights to strontium-90 contamination.
Elmerine Whitfield Bell, Dallas, Texas. Mrs. Bell, daughter
of Elmer Allen (CAL-3), a subject in the University of
California, San Francisco plutonium injections, spoke about her
father and her family s experience living with the effects of his
poor health. She also presented written testimony from her
daughter about Mr. Allen s life.
Mrs. Bell said her father was not properly informed nor did
he give proper consent to plutonium injections, and she urged
members to look critically at the UCSF committee report on the
injections.
Cooper Brown, Takoma Park, Maryland. Mr. Brown, of the Task
Force on Radiation and Human Rights, presented a paper on
principles the task force believes should guide remedies
recommendations of the Advisory Committee.
Dr. Oscar Rosen, Boston, Massachusetts. Dr. Rosen, commander
of the National Association of Atomic Veterans, praised the work
of the Committee in making the documentary record available to
citizens. He also praised the Committee s disclosure of the
experimental nature of fallout studies in Operation Jangle of
1951. Dr. Rosen urged members to address a wide range of issues
of importance to veterans exposed in nuclear weapons testing.
Glenn Alcalay, New York, New York. Mr. Alcalay spoke about
his work since 1975 with women of Utirik, an atoll in the
Marshall Islands exposed to fallout during weapons testing. He
criticized Brookhaven fallout studies for failing to assess the
impact of radiation on fertility and birth outcomes in the
Marshalls. He urged the Committee to recommend an epidemiological
study of women in the Marshalls.
Denise Nelson, Bethesda, Maryland. Mrs. Nelson spoke about
premature deaths to downwinders from the Nevada Test Site and
analogized their exposures to Nazi atrocities. She said the
Radiation Exposure Compensation Act has not resulted in justice
to downwinders, as many families medical expenses have far
outstripped compensation payments.
Chris DeNicola, Valerie Wolf and Claudia Mullen, of New
Orleans, Louisiana. Ms. Wolf said research subjects had been
victimized as children in mind-control experiments, some of them
involving radiation and torture. She said her clients in therapy,
including Ms. DeNicola and Ms. Mullen, recalled similar incidents
and suffered similar ailments. She urged the Committee to ensure
full disclosure of CIA and military experiments along the lines
of MKULTRA, Bluebird and Artichoke.
Ms. DeNicola recalled being the subject of torture and
exposure to drugs and radiation in Kansas City and Tucson, in
1966-76. She said this was part of an effort to train her as a
spy and assassin.
Ms. Mullen described a series of exposures to drugs and
abuse from age seven in 1957, continuing to 1984. She said the
doctors involved were funded through Edgewood Arsenal in
Maryland, and that numerous atrocious acts were committed by
doctors and government officials.
The panel of commenters called for appointment of a new
commission to investigate the mind-control experiments.
Suzanne Starr, Chimayo, New Mexico. Ms. Starr said that in
1993 she began to recall experiences similar to those reported by
Ms. DeNicola and Ms. Mullen. She described being the subject of
abusive types of treatments or experiments as a child in Colorado
in the 1950s and into the early 1960s. She said she continues to
receive program messages urging her to kill herself. She said
through therapy that she has found the strength to speak about
her recollections.
Steven Schwartz, Washington, D.C. Mr. Schwartz, a guest
scholar at the Brookings Institution, spoke about the
difficulties of tracking down documentation regarding the
development and cost of the nuclear weapons complex. He said many
records were destroyed and that adequate financial information
was not kept by government agencies. He also discussed the
difficulties of obtaining information through the Freedom of
Information Act (FOIA) process.
Update: Knoxville Small Panel Meeting. Nancy Oleinick.
Dr. Oleinick briefed members on the Knoxville small panel
meeting, held March 2. She noted the number of scientists and
physicians who joined subjects and advocates on the list of
persons speaking to the panel. Dr. Oleinick said the panel noted
the expressions of fear and concern from citizens working or
living near Department of Energy facilities; while these
exposures may not be delimited in the charter of the Committee,
Dr. Oleinick said that the Committee may wish to acknowledge
these concerns and urge government agencies to take appropriate
action.
Dr. Oleinick said that problems of access to information are
a continuing theme from public comment participants. She also
noted that a number of patients and families expressed their
gratitude that Oak Ridge facilities were available for
experimental treatments for leukemia and other diseases.
Dr. Faden thanked Dr. Oleinick and Dr. Royal for
representing the Committee in Knoxville.
Committee Discussion: Final Report. Dan Guttman.
Mr. Guttman updated members on efforts of the staff to draft
chapters for the final report.
Anna Mastroianni, staff associate director, briefed members
on the schedule for chapter drafts to be reviewed by Committee
members.
Dr. Royal asked that members receive comments from other
members, so that members get the benefit of others observations.
At the suggestion of Dr. Katz, the staff was authorized to
approve stylistic changes, but was directed to note for members
the incorporation or the rejection of substantive suggestions
from Committee members.
Dr. Thomas and Dr. Macklin questioned the proposed
organization of isotope distribution and biodistribution
chapters, and Dr. Thomas suggested that the issues might be
better organized along lines of therapeutic or diagnostic use and
of experimental use that is not of benefit to the patient. Dr.
Faden said a difficulty is the relative lack of information on
radiotherapies, and Dr. Glatstein added that the Committee could
not survey all subjects in the field of radiation.
Dr. Thomas said that the reader of the proposed chapters
might get the impression that the high toll of problematic
research is the only story, without the story being told about
the development of radiotherapies and both their costs and
ultimate successes.
Thursday, March 16, 1995
Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz,
Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy
Oleinick, Henry Royal, Mary Ann Stevenson, Duncan Thomas, Reed
Tuckson.
Statement of Senator Wellstone
Senator Paul Wellstone of Minnesota addressed the Committee
and urged members to investigate thoroughly the concerns of armed
services veterans exposed in connection with weapons tests. He
recounted the experience of Minnesota veterans who today feel
misled and neglected by their government because of health
problems they ascribe to exposures in the nuclear tests.
He noted the disclosure of fragmentary evidence of secret
Veterans Administration files on veterans exposed during weapons
testing. The senator informed the Committee of a preliminary
study by the National Academy of Sciences that is considering
whether it is feasible to do a full-scale medical follow-up
study.
He added that the Committee s analysis of intentional
releases, though predicated on radiation exposures, might well
apply to the spraying of zinc cadmium sulfide over many cities,
including Minneapolis, as part of dispersal studies for
biological and chemical warfare purposes in the 1950s and 1960s.
Members questioned Senator Wellstone about the Committee s
scope of inquiry regarding exposures to veterans; ethical
criteria to judge intentional releases; and eligibility rules in
existing radiation exposure compensation laws.
Committee Discussion: Introductory Chapters. Ruth Faden.
Members discussed staff suggestions for introductory
chapters in the Committee s final report.
Subjects discussed by members included the treatment of the
Nuremberg doctors trials and the Wilson memorandum that flowed
from principles promulgated at the Nuremberg trials; the Cold War
backdrop for experiments in the United States; the sense of
betrayal felt by affected citizens toward their government; the
Nuremberg Code as a description of accepted research practices of
its time; and the need to capture first principles in
introductory sections of the report.
Dr. Royal emphasized that members need to make drafting
suggestions as early as possible. Dr. Katz suggested that the
opening chapter may be the last to be finalized.
Dr. Tuckson said that the introductory chapter should lay
out the questions the Committee was formed to answer. Professor
King said Dr. Tuckson s suggestion should lead the Committee to
begin its report with the story of how the Committee was formed
in the wake of the 1993 Albuquerque Tribune series.
Members discussed the draft Part I, Chapter 2. Subjects
discussed included the use of Walt Disney references in the
draft; some members suggested starting with the existence of
radioactivity since the dawn of time. Professor King said the
audience for the final report is the American public, requiring
the broadest treatment of the story uncovered by the Committee.
Dr. Royal suggested that the final report should be useful
to policymakers first of all, as the Committee wants the
government and the professions to take steps to avoid mistakes of
the past.
Dr. Oleinick suggested places where the chapter might note
the broader context of useful radioisotope research, and the fact
that the vast majority of experiments were on animals.
Members suggested small editorial changes to make the
chapter more clear, and Mr. Guttman said that timelines will be
included in future drafts.
Dr. Tuckson said the chapter, including the Walt Disney
reference, usefully illustrates how people thought of radiation
in periods covered by the report. He said another audience for
the report is the large number of veterans and other stakeholders
who have appeared before the Committee.
Members discussed Chapter 2-A draft, and the question of
whether a stand-alone chapter of testimony from public comment
participants should be included. Dr. Macklin suggested it should
be included as parts of relevant chapters, but Dr. Thomas said
that he felt it a powerful statement of pain felt by many
citizens. Dr. Glatstein and Professor King said chapter 2-A
should be in the report, but perhaps as an appendix rather than
as a chapter.
Dr. Tuckson suggested that the chapter should include a set
of statements representative of all the general categories of
concerns addressed in public comment periods.
Dr. Faden said the decision on whether to include a separate
testimony chapter would be revisited after more chapters are
complete. She said it may also be a relevant part of the findings
chapter.
Committee Discussion: Recommendations. Ruth Faden.
Dr. Faden briefed members on plans for a findings chapter
that would precede the recommendations of the Committee in the
final report. She emphasized that the discussion was intended to
elicit from members general areas that should be addressed in the
findings, but not to make final conclusions about findings or
recommendations flowing from them.
Members addressed drafts prepared by the staff. Issues
discussed by members included the order and organization of the
findings; the need to propose attainable goals and objectives to
government agencies; and the need to craft findings relevant to
experiments of opportunity and intentional releases, as well as
traditional biomedical experiments.
Members discussed findings regarding secrecy; linkages of
culpability and compensatory recommendations; phrasing
recommendations to maintain editorial consistency; the difficulty
of matching abstract cases, and appropriate compensation.
Members noted the distinctions between cases in which
exemplary damages should be paid by the government, and the
problems of drawing distinctions with other cases in which harms
or wrongs have occurred, but where the historical record may not
be clear enough to provide guidance about compensation or other
remedies.
Dr. Royal also noted that widely varying judgments may be
made about risks and benefits of physical harms.
Members discussed the difficulties of demonstrating
causation, and whether the draft findings inconsistently held
that presumptions could be made with respect to informed consent
and not made with respect to physical harms. Mr. Feinberg said
the draft findings envision a panel of scientists to develop
reasonable presumptions.
Mr. Feinberg said that if medical presumptions cannot be
established, then a general apology might be available to those
wronged, but compensation could only be granted to those persons
who are victims of government cover-ups. Professor King noted the
difficulty for many subjects in demonstrating that they were
victims of a government cover-up.
Presentation: National Research Council Study, Alaska I-131.
Chester M. Pierce.
Dr. Chester Pierce, chair of the National Research
Council/Institute of Medicine Committee for Evaluation of 1950s
Air Force Human Health Testing in Alaska Using Radioisotope
Iodine-131, briefed members on the progress of the study.
Members questioned Dr. Pierce and Mr. Loren Setlow, director
of the NRC/IOM study, about the background and training of the
principal investigator and about the investigator's training at
Chicago for use of isotopes provided by the Atomic Energy
Commission; about consent issues raised by subjects in 1994
hearings before the NRC/IOM panel; about the language and
cultural difficulties between native Alaskan subjects and the
investigators; and about what the NRC/IOM panel considered
generally acceptable medical standards in the 1950s.
Committee Discussion: Recommendations. Ruth Faden.
Members resumed their discussion of remedies. Mr. Feinberg
and Dr. Macklin said issues of justice might guide the
Committee s decision about presumptions for the purpose of
remedies, but Mr. Feinberg said that it is important that the
Committee adopt a scheme that avoids the scientific difficulties
of setting either restrictive presumptions or overly generous
presumptions that would be too costly and thus unlikely to be
adopted by the government.
Dr. Glatstein said the intentional releases and other mass
exposures should be treated separately, with generous
presumptions for medical problems thought to be related to mass
exposures.
Members revisited the issue of biomedical experiments in the
draft findings. Dr. Thomas said the Advisory Committee should
recommend that Congress give policy guidance up front to allow
scientists to make reasonable judgments of probability of
causation of harms.
Professor King said that dealing with mass exposure
presumptions might obviate discussion about what Mr. Feinberg
called fine and potentially invidious distinctions among
different types of experiments.
Professor King summarized the question: If the Committee
concludes that consent was likely not obtained in many cases,
then a presumption is created for remedies, without strict
standards of causality in scientific terms.
Dr. Thomas said there is a tradeoff: with high likelihood of
culpability, generous presumptions on causality; with low
likelihood of culpability, higher standards for causality.
Dr. Katz said that it is important that remedies be readily
applicable and should not be subject to more lengthy deliberation
before being put into effect.
Friday, March 17, 1995
Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King,
Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry
Royal, Philip Russell, Duncan Thomas, Reed Tuckson.
Staff Report: Subject Interview Study. Jeremy Sugarman, Nancy
Kass, Steve Goodman.
Dr. Sugarman briefed members on the progress of the subject
interview study. He said 16 of 19 IRBs at institutions approached
about the study had approved it, and the 16 sites include an
equal number of university, veterans and community hospitals, and
governmental research institutions.
Dr. Kass said 79 in-depth interviews have already been
completed, and she outlined plans for compiling and assessing the
data. Dr. Faden introduced Dr. Steve Goodman and Ms. Monica
Schoch-Spana, who are working on the project.
Members questioned the staff about the sorting and
quantative analysis of data and initial impressions from the
early returns of in-depth interviews.
Staff Report: Research Proposal Reviews. Gail Geller, Sara
Chandros.
Ms. Chandros reported that 59 radiation reviews and two
nonradiation reviews were completed and in the database by March
13. She said more than 100 reviews remain to be done to meet the
Committee s original goals for the project.
Ms.Chandros briefed members on the preliminary findings of
the study. She said almost half of the surveys completed have
been rated highly, with eight rated as raising serious ethical
concerns. The latter generally were proposals involving higher
levels of risk, Ms. Chandros said.
Members agreed to prioritize the pool of reviews to reach a
goal of five studies per cell of the analytical grid, reducing
the number of reviews to be done by about 20. Nonradiation
comparison studies would be reduced to about 40 as a result.
Members will also be paired with staff members as co-reviewers to
increase the number of reviews completed.
Members also discussed the process of rating studies and how
studies are packaged for review.
Dr. Katz reported on his review of 50 protocols. Thirty
represented minimal or no risk, as in questionnaire-type studies
or tracer studies. Dr. Katz said of the 20 involving higher risk,
four were handled well. Ten studies would be given low ratings,
on the ACHRE scale, ratings of 4 or 5, Dr. Katz said, outlining
specific risks that he felt were very poorly dealt with, or
entirely left out of, consent forms.
Dr. Russell suggested that a problem is the interweaving of
risk discussions with other explanations, and Dr. Royal added
that few protocols he has seen provide adequate discussion of
quality of life issues facing patients. Dr. Royal said the
possibility of benefits is also often poorly explained to
patients.
Dr. Macklin noted the Committee does not have available to
it the verbal presentations to IRBs, in cases where the
investigator is present for review of protocols. Dr. Macklin said
there may be a huge variability in IRB processes, including
whether investigators are disdainful of the IRB process, as she
has found some to be.
Dr. Katz said his conclusion is that, among studies
involving more than minimal risk factors, a primary
responsibility of IRBs, to review closely the consent process, is
not being adequately met 50 percent of the time. Dr. Faden noted
that these are all approved projects, currently being conducted
across the country.
Dr. Katz also noted that the longer consent forms, some of
them nine or ten pages, were the most unclear about risk and
benefit.
Dr. Geller said there may be problems with IRB review, in
terms of IRBs being willing to question the scientific merit of a
protocol. Dr. Russell said there is often no funding agency or
other body to which IRBs could refer protocols that raise
questions of scientific merit.
Committee Discussion: Forward-looking Recommendations. Ruth
Faden.
Members discussed in general terms a list of ideas for
forward-looking recommendations for the final report.
Dr. Macklin said that the recommendations should make clear
whether there should be uniform enforcement of ethical standards
for research. Achieving uniformity in today's decentralized
system may involve changes that will not be popular with some
participants in today's system, Dr. Macklin said.
Dr. Katz said federal regulations need to be revised
radically, and that recommendations directed to IRBs may not be
helpful in light of a lack of a national board to oversee the IRB
process.
Dr. Russell said the search for uniformity across the
federal government is likely to bring down the average quality
rather than to raise it. He doubted the wisdom of adding another
centralized level of bureaucracy.
Dr. Faden asked that the staff circulate an article by Dr.
Katz on the issue of a national board to oversee human subject
research.
Mr. Guttman said the recommendations might include
suggestions about what a citizen should ask if he/she or a family
member is asked to be a study subject.
Dr. Glatstein said federal funding should be tied to
educational requirements for IRBs, or a national conference for
focusing on consent issues. NIH has not been a regulatory agency,
he said.
Dr. Russell said the bureaucratic workload should be reduced
to focus more attention on higher-risk protocols.
Dr. Glatstein said that there is an underlying tendency
among IRB members to support investigators proposals,
particularly when the goal of the study is perceived as
particularly valuable. Members discussed the wisdom of adding
more lay persons to IRBs.
Members generally agreed with addressing in the final report
concepts of differentiating research from treatment; better
communicating of risk and benefit; and avoiding presumptions of
agreement in consent forms. Members also discussed the role of
drug companies in funding clinical trials.
Dr. Royal said that oversight of research should not be
vested in funding agencies, which have a vested interest in
funding more research. Consent forms are preserved under existing
regulations, and perhaps should be audited or reviewed, he said.
Having some feedback about issues of communicating risk and
benefit to the patient would provide the most bang for the buck
in federal terms, Dr. Royal said.
Dr. Glatstein said the National Cancer Institute already
reviews consent forms, but he said that a recommendation might
include focusing such agencies more on issues of communication
with patients.
Drs. Russell and Glatstein said regulatory agencies such as
the Joint Committee on Accreditation of Hospitals tend to look at
whether IRBs exist, but a Committee recommendation might seek
more attention on whether they are doing a good job.
Members discussed ideas for more education for IRB members
on ethical concerns.
Dr. Tuckson said that the big picture is that
recommendations ought to change govenrment behavior. Professor
King said certification of IRB members may not achieve Dr.
Tuckson s big-picture goal, and that the responses to these
issues must be more than perfunctory on the part of the
participants in the medical community; the recommendations must
be more than credentialism through certification, but should,
perhaps, suggest ways for IRBs to accomplish goals of real
communication in the IRB and elsewhere in the system.
Dr. Faden said ideas for educational recommendations should
be aimed at the widest community of biomedical research.
Dr. Royal said the advantage of certification is that people
cannot say after the fact that they didn t know the rules.
Dr. Macklin concluded that both sides of the certification
discussion are correct.
Dr. Tuckson said that there needs to be some convening of
leadership in American universities and hospitals, to determine
how to achieve important ethical goals.
Professor King said the IRB enterprise should empower lay
members to address ethics issues.
Dr. Tuckson said the relevant background material is also
important and should be readily available.
Members discussed accountability, oversight and sanctions.
Members focused on questions of what is practical in a time of
declining federal spending, and what actual monitoring of the
consent process is done today. Dr. Macklin noted that oversight
and monitoring of the consent process is envisioned in today's
regulations, but is in fact rarely done.
While Dr. Katz suggested that such reviews would be very
unpopular with investigators, Dr. Glatstein said that regulations
tied to funding will be obeyed.
Members asked staff for details about sanctions that might
be deployed to improve ethical conduct. Dr. Macklin suggested
that IRBs may not be the best mechanism to determine whether
sanctions should be invoked.
Members moved to a discussion of potential categories of
remedies in response to findings about intentional releases and
mass exposures. Dr. Glatstein said planned intentional releases
or exposures of soldiers should require written authorization
from the President of the United States.
Dr. Russell noted that civilian authority is already
asserted over the military by the service secretaries, who are
appointed by and responsible to the President. Dr. Russell also
noted that today's armed forces regulations include extensive
risk analyses, extending beyond radiation. He suggested
addressing recommendations to the interface between training and
research activities, and particularly embedding instruction in
human research ethics in th education of officers of the U.S.
armed forces.
Dr. Faden asked the staff to provide a background paper on
mechanisms and recommendations regarding waiver of exposure
standards. Members also asked for clarification of issues
involving medical interventions to protect troops.
Members generally approved addressing issues of openness,
including preservation of the Advisory Committee document
collection for citizen use, and an ombudsman for citizen access
to archives on this subject generally. Members asked for detail
about a proposed registry of human subject research.
Committee Discussion: Retrospective Recommendations and
Notification. Ruth Faden.
Members discussed the charter requirement that the Committee
address the issue of notification of subjects of experimentation.
Dr. Faden said the Committee's research into children,
prisoners and fetuses exposed to ionizing radiation have been the
principal focus of notification requirements. Dr. Thomas has also
been asked to consider issues of genetic effects and notification
of subsequent generations.
Dr. Royal asked that staff further research a suggestion
that a notification effort be aimed at potential thyroid cases
where exposures suggest 1 in 1,000 chance of abnormalities.
Dr. Thomas and Professor King suggested that there are
models for inquiring of people whether they would like to know
about potential threats, e.g. genetic screening cases.
Professor King said issues might involve reproductive
health. Dr. Royal said large-dose studies of I-131 have shown no
connection with reproductive health.
Dr. Royal said the vast increase in efficiency of diagnostic
techniques results in more treatment of slow-growing cancers,
like thyroid and prostate, which may result in more morbidity
because of interventions arising from notifying persons than from
leaving well enough alone.
Professor King said the critical issue is putting those on a
research protocol in the past on the same footing as those today.
While there are people who do not want to know, they would have
the right to know today, she said.
Dr. Tuckson said that the individual should have the
opportunity to seek more information, similar to testing for
Parkinson s disease genes. Public concern is very great and the
issue must be addressed, even if there remain great practical
difficulties, Dr. Tuckson said.
Dr. Royal said notification is also bound up with the
knowledge of the circumstances of the experiment, so that the
chance of a reasonable diagnosis and treatment is increased.
Dr. Tuckson said that institutions that conducted radiation
experiments have a moral obligation to find subjects and notify
them.
Dr. Macklin said it is a matter of rights, the exercise of
which sometimes results in harms.
Dr. Faden summarized the discussion: that people have a
right to know if they were subjects, and that no barriers should
be erected to people finding out. She said the Committee would
leave open for the moment the criteria by which institutions
should choose which experiments to focus notification efforts.
Dr. Thomas added that any program should respect the right
not to know of those who do not wish to know.
Dr. Faden said the practical problem is finding people.
Meeting Update
Dr. Faden briefed members on the upcoming meeting schedule.
As the designated federal official, Mr. Guttman closed the
meeting at 4 p.m.
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