ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS

                                 * * * * *

                              PUBLIC MEETING

                                 * * * * *

                                 WEDNESDAY
                               MAY 18, 1994

      The Advisory Committee met in the Washington Room at
Ramada Plaza Hotel, 10 Thomas Circle, N.W., Washington, D.C., at
9:00 a.m., Ruth Faden, Chair, presiding.
COMMITTEE MEMBERS:

RUTH FADEN, Ph.D., M.P.H., Chair
KENNETH FEINBERG, J.D.
ELI GLATSTEIN, M.D.
JAY KATZ, M.D.
PATRICIA KING, J.D.
SUSAN LEDERER, Ph.D.
RUTH MACKLIN, Ph.D.
LOIS NORRIS
NANCY OLEINICK, Ph.D.
HENRY ROYAL, M.D.
MARY ANN STEVENSON, M.D., Ph.D.
DUNCAN THOMAS, Ph.D.
REED TUCKSON, M.D.

STAFF:

FAITH BULGER, J.D.
KRISTIN CROTTY
JERRY GARCIA
DAN GUTTMAN, LLB
GREGG HERKEN, Ph.D.
DEBORAH HOLLAND, M.A.
DENISE HOLMES, J.D., M.P.H.
JEFFREY KAHN, Ph.D., M.P.H.
LANNY KELLER
JEANNE KEPPER
STEPHEN KLAIDMAN
ANNA MASTROIANNI, J.D.
JONATHAN MORENO, Ph.D.
RON NEUMANN, M.D.
DAVID SAUMWEBER, M.A.
GARY STERN, J.D.
JEREMY SUGARMAN, M.D., M.P.H., M.A.
DONALD WEIGHTMAN, J.D.
GILBERT WHITTEMORE, Ph.D.     C-O-N-T-E-N-T-S

CALL TO ORDER - DR. RUTH FADEN                                            4

PRESENTATION ON ETHICAL PRINCIPLES
OF HUMAN RADIATION - DR. RUTH MACKLIN                                    25

PRESENTATION ON THE HEALTH EFFECTS
OF RADIATION - DR. HENRY ROYAL                                           67

HISTORY OF HUMAN EXPERIMENTATION IN
THE UNITED STATES - DR. SUSAN LEDERER                                   110

REPORT FROM STAFF - THE HISTORY OF
HUMAN RESEARCH POLICIES AT THE
VARIOUS AGENCIES - DR. JEFFREY KAHN                                     139

REPORT FROM STAFF - THE CINCINNATI
EXPERIMENTS - DR. RON NEUMANN                                           158


PUBLIC COMMENTS:

E. COOPER BROWN, NATIONAL COMMITTEE FOR
RADIATION VICTIMS                                                       221

WALLACE CUMMINS, THE RADIATION HEALTH
EFFECTS PUBLIC INTEREST LAW GROUP (RADLAW)                              231

FRED ALLINGHAM, THE NATIONAL ASSOCIATION
OF RADIATION SURVIVORS                                                  239

DR. DARYL KIMBALL, PHYSICIANS FOR SOCIAL RESPONSIBILITY                 256

REPORT FROM STAFF - THE GREEN RUN
TEST - DR. GILBERT WHITTEMORE                                           269




                           P-R-O-C-E-E-D-I-N-G-S

                                                                  9:10 a.m.

      MR. CAPLAN:  Good morning, everyone.  Welcome.

      As the designated federal official for this meeting,
my name is Phil Caplan from the White House.  I hereby open the
meeting and turn it over to Chairwoman Ruth Faden.

      CHAIRWOMAN FADEN:  Good morning.

      It's hard for me to believe this is only our second
meeting.  It has so taken over at least parts of our lives that I
feel as if we've been doing this always.  It's kind of like after
a child is born and you can't remember the time before that.

      Welcome to everyone.  We have a very, I think, packed
and important agenda for the next two days.  What I'm supposed to
do now is orient all of us to what is going to happen during the
next two days both in terms of how the agenda will proceed and
how the organization of the agenda fits with the objectives that
we've created for this second meeting.

      But before I do that, I want to make one really
unfortunate announcement, and that is that recently Frank Press
resigned from the Committee.  He wrote a very lovely letter
saying that he was so overwhelmed by the importance of the
Committee and had not realized how frequently the Committee would
meet, and so, basically, was resigning because he didn't see that
he had the time to do right by his obligations as a Committee
member.  It is a very fine letter, and I'm going to ask him, if
it's all right with him, to circulate it to the other members of
the Committee, but as it was written just to me, I feel like I
can't give it to everybody without his permission.  I'm sure
he'll say yes.

      It saddened me very much personally.  He said some
nice things about everybody and how we shouldn't take it
personally.  So we're not going to take it personally.

      (Laughter.)

      So far as I know, nobody offended him or otherwise
made him unhappy.

      Now the issue has emerged whether Frank Press, now
that we have one slot free, whether we ought to proceed to fill
it or whether we ought to go on as we are, since we've already
kind of formed a group identity.  I checked with the
Administration, and what we're looking into now are the
procedures for determining how we might get another member to the
Committee and reasons why and why not.  I'll keep everybody
posted as to how this proceeds.  I'm not sure what the answers
are, but if any Committee members have any thoughts about whether
you think it would be a good idea to seat another member or not,
or what kind of other member it would be -- it would be good to
see what reasons why you think it would be just as well at this
point to proceed apace -- please let me know.  The judgment I
think is not in the end ours to make, but I think our advice
would certainly be seriously listened to.

      Also, Phil Russell, who was absent at the first
meeting, and, unfortunately, is absent at this meeting, wants to
be understood to be very much a member of the Committee.  He just
has a horrible travel schedule that we just couldn't get
everybody, and he was one that we couldn't get.  He has been very
involved in the work of the Committee.  He's come to the
Committee offices and met with staff, read over stuff, brought in
things.  So he's a kind of behind-the-scenes member.  The
unfortunate thing is the rest of us haven't had a chance to
interact with him.

      Will he be able to join us for the next meeting?  He
will be joining us for the next meeting.  So although none of us
have had a chance to work with him yet, staff has and he very
much is a member of our Committee.

      Okay, that's it for Committee member business.  We're
expecting Reed to come.  So other than Phil, we have a full
Committee, which is extraordinary given the short turnaround time
that we had for scheduling this next meeting.

      By way of orientation to the meeting, there are
really three core objectives for what we're supposed to
accomplish over these next two days.  Let me run them by you and
then fit them, also, with the agenda for the meeting.

      Our first objective is -- already we're changing the
agenda, but that's okay.  I can cope.  It's all right.  It's
fine, no problem.  We can do that.

      All right, the first objective is mutual education. 
As we discussed last time -- good morning; I just announced you
were on your way.  So there you go; your timing was perfect.

      As we discussed last time, we all come from different
backgrounds and we have a great need to get up to speed, at least
in a minimal way, with each other's areas of expertise.  So we
have a goal over the next couple of sessions, which is mutual
education.  So that we can start, as we begin our hard
deliberations, with at least some common language.

      So to that end, we have three presentations for this
meeting.  We will have several more for the next meeting and
several more for the meeting after that, because we have so many
wonderful committee members, all guaranteed that they will do
their show and tell eventually.  So we have three today.

      We're shifting the order apropos this last note
because of a technical difficulty.  Ruth will go first and talk
about ethical principles of human radiation.  Then -- excuse me,
ethical principles of human experimentation.  Then following
Ruth, if our technical problem is resolved, Henry will give us a
presentation on the health effects of radiation, and then Susan
Lederer will talk to us about the history of human
experimentation in the United States.

      These are all preliminary kinds of presentations. 
We'll probably revisit all of these issues over and over again,
but it's wonderful that we can get a chance to learn something
all together.

      So that's our first objective for today.  We will,
hopefully, accomplish that by this morning.

      The second objective for this meeting, which is an
objective we have for every meeting, is that by the conclusion of
business tomorrow we will have provided the staff with specific
direction to keep it profitably employed for the next four weeks,
as we need to keep the momentum rolling.  We need to give staff
direction that's detailed enough and wise enough, so that they
can make good use of their time between now and the next session. 
To that end, we structured the agenda as follows with basically
two components:

      If you will recall, at the close of business at our
first meeting we did leave the staff with four specific tasks,
and what we will do today and tomorrow is hear from the staff,
and there's, of course, comparable material, relevant material,
in your briefing book on each of these points, as to staff's
progress on the following four tasks which we gave to them at the
end of the first meeting.

      First, we asked them to begin the process of
identifying the ethical policies and standards with respect to
human subjects research of the relevant federal agencies, and
we'll get a report on how far staff has gotten with that task
this morning.

      We also asked staff to prepare three case studies for
methodology purpose; that is, to look at three case studies in
terms of the kinds of data that are available, in what form those
data are available, so that we could begin to get a sense of
what's available to us and how much we can learn from what kinds
of information.

      We identified, just to remind everyone, three cases: 
plutonium, the Cincinnati experiments, and the Green Run test,
and we will get reports from staff on those three case studies.

      We also asked the staff to address the status and
evaluate the status of the agency data collection efforts with
respect to human radiation experiments up to this point, and the
staff has been able to make progress in the past three-plus weeks
with respect to two agencies, DOE and DHHS.  We'll get a report
on that.

      Then, also, we asked the staff to prepare some
guidance with respect to outreach options, and we will have a
report on that.

      So the first part of setting the objectives for the
next meeting is hearing how far we've gone with our tasks that we
gave the Committee staff to address at the last meeting.  We will
do that pretty much this afternoon and then tomorrow morning.

      We have also set aside all of tomorrow afternoon for
the Committee to specifically debate where it wants the staff to
go next and how Committee members should work with staff to
accomplish this interim tasks, and the central procedural issue
for tomorrow afternoon is the question of the formation of
subcommittees between staff and Committee members.  We're now at
the point where, hopefully, we can have a good debate or a good
discussion about how we might want to divide ourselves up based
on interest and commitment, and so on, to work with staff in
advancing the tasks that we think need to be accomplished.  We'll
talk about that tomorrow afternoon.

      This second objection -- that is, giving the staff
marching orders for the next four weeks -- is absolutely key. 
Staff can only be as productive as the Committee's guidance is
specific and good.  So if we don't do our work well, the staff
can't do its work well.

      Retrospectively, I have to say we did a great job
defining tasks at our last meeting.  It's kind of amazing that we
were able to come up with such productive and useful and doable
tasks at the end of our first meeting, when we hardly knew who we
were, let alone what we were doing.

      As it turns out, as we will hear, what we asked the
staff to do produced a lot of very interesting and insightful
information that will, I think, make it much easier for us to
consider where to go next.  But we have to do at least as good a
job this time as we did last time.  In addition, we need to now
figure out how we're going to work more closely as Committee
members with staff.

      Finally, let me just say that our third objective for
this meeting is also an objective we have for every meeting,
which is to enrich our deliberations with input and information
from the public.  So we have set aside, to that end, an hour this
afternoon for comment from the public.  We have been notified
that four individuals would like to speak to the Committee.  We
hope they will be here and we will set aside an hour to listen to
them and talk with them.

      So those are the three things we have to do today: 
educate ourselves a bit today and tomorrow, figure out what we
want the staff to do next and how we will do it with them, and
learn from the information we hear from members of the public.

      I'd like to turn now from this orientation to the
structure of the meeting and our objectives for this meeting to
the really delightful task of introducing our staff.  The staff
has grown exponentially in wonderful ways.  We have added some
wonderfully talented people to the wonderful talented people we
already had at the first meeting, and, as you will see in just a
moment, I think there's now more staff -- more staff than there
are Committee members?  Have equal employees or are we beyond
that?

      MR. GUTTMAN:  A number of the people are part time. 
So it's not like we're busting the budget.

      (Laughter.)

      We can use more scientists if there's anybody out in
the audience.

      (Laughter.)

      CHAIRWOMAN FADEN:  That's important.  Actually, as we
discussed this, I was reminded to make sure that we didn't get
unrealistic expectations.  So a large number of the staff are
part time because of the last-minute way in which we've had to
pull this together.  But, nevertheless, everybody who works part
time works full time in some sense -- anyway, we hope.

      Let me just take a minute.  As the staff has grown
and as we need to get something done, as we needed to get
something done over the past couple of weeks, we needed quickly
some way of organizing how the staff should proceed, and
tentatively has emerged something like the following division. 
This is, I suspect, a temporary way of thinking about what our
responsibilities are in this Committee, but it's worked so far as
a kind of rough organizing principle.

      Basically, as the staff started working, it began to
emerge that really, at least at this point, we were thinking
about the Committee's responsibility to tell two very
interrelated stories.  One story has been dubbed roughly the Cold
War story, which is the government's involvement of human beings
in science in order to advance defense and national security
interests during the Cold War.

      The other story we've tentatively sort of dubbed the
ethics in science story, which is the story that tells about the
evolving or shifting or not evolving and not shifting standards
and practices with respect to the involvement of human subjects
in research.  That story begins in 1944 and, obviously, continues
to the present, whereas the Cold War story has a kind of Cold War
conclusion.

      Now the two stories are, obviously, very
interrelated, particularly as you start to think of special
cases.  Whether these two stories end up being one story in the
end or we find that we're really addressing twenty stories and
not one story or two stories remains to be seen, but as it has
happened in the past couple of weeks, that's sort of been a handy
metaphor, if nothing else, for figuring out who is going to be
working on the Cold War story and working on the ethical
standards story, or whatever the deal is.  So you may hear some
staff make mention of that as they describe what they're doing.

      I'm going to turn this over to staff, so people can
just go around and give you a clue of briefly who they are and
where they have been spending their time.

      But let me just say two things:  first, it's really
incredible how much has been accomplished in the past -- what is
it? -- three weeks.  It's really amazing.  While you hear of all
these people, some of these people joined the staff yesterday or
the day before.  Nevertheless, everything has happened in such
short time frame and so, so well; it's really been a great
personal source of satisfaction for me to see it come together so
ably.

      What I'd like to do is ask everyone, the staff, to go
to the nearest microphone.  The reason we have to do that, even
though we've asked you to be brief, is that we need to get it on
the record for the transcription.

      Could you start?

      MR. GUTTMAN:  I'm Dan Guttman.  I'm still the same
person I was when I introduced myself last time (Laughter), but
at least we have some staff.  I wish the half-time people were
full time because they're terrific, and everybody else is really
looking -- I can't tell you what kind of a pleasure it's been to
be with these people as a fly on the wall.  It's terrific.

      MS. MASTROIANNI:  Anna Mastroianni.  I'm a lawyer and
Director of Committee Affairs and Deputy Staff Director.  I'm
also a Senior Policy and Research Analyst.  I'm most interested
in the research at this portion of the story.

      DR. KAHN:  Jeffrey Kahn.  I'm Staff Director and
Senior Policy and Research Analyst.  I'm trained in bio-ethics
and health policy, and I spend 60 percent of my time -- really
100 percent of my time on this project, but I'm supposed to be 40
percent of the Medical College of Wisconsin.  Hopefully, they
won't read the transcript from this meeting.

      (Laughter.)

      I've been working substantively on the history of
research on human subjects policy at the various agencies, in
addition to working with a number of people pulling the staff
together to date.

      I'd like to say, too, before the rest of the folks
introduce themselves, that a few people are not able to be here
today.  I'd like to point you to their biographical sketches, so
you can get a sense of who they are.  They are Jonathan Moreno,
Gary Stern, David Saumweber, Jonathan Engel, Deborah Holland,
Jeanne Kepper, and Sally Rhoadarmer.  They're on your staff-
designate roster list.  So if you'll just look to their sketches,
you'll get a sense of who they are, and they'll be with us next
meeting.  Most of those folks have just joined in the last few
days.

      MS. BULGER:  My name is Faith Bulger and I'm a lawyer
by training, and I've been primarily involved with contact with
the Department of Health and Human Services, Department of
Energy, and, most recently, the Veterans Administration and
Veterans Affairs.  I have made initial contact with some of the
agencies, worked with people over there, and been involved in
drafting some of the reports.

      MS. CROTTY:  My name is Kristin Crotty.  Yesterday
was my first day at the Committee, and I'll be handling
congressional relations and public outreach.

      MS. HOLMES:  My name is Denise Holmes.  I am also an
attorney by training.  I also have a master's in public health. 
I started on Monday, and my initial effort has been with the
Department of Veterans Affairs working on their records
collection.  I'm going to be filling -- Faith will be
transitioning out of that and I'll be working in that.  I'll
probably also have some work with collection at Department of
Health and Human Services, and whatever else Ruth tells me to do.

      MR. WEIGHTMAN:  My name is Don Weightman.  I, too, am
a lawyer by training, although in a much earlier part of my life
I studied philosophy at Boston University.  Most recently, I've
been working at the Office of Thrift Supervision, working on the
role of professionals and problems with their standards and the
savings and loans collapse.

      Before that, I was at Spiegel & McDiarmid working in
the same office, although not quite in the same room, as Dan
Guttman.  The work I was doing there was investigating another
problematic part of the nuclear program in this country dealing
with the high cost of nuclear construction during the seventies
and eighties.

      Although it's very tentative, my understanding is
that what I'll be doing when I'm here officially as of June 1 is
trying to coordinate the data gathering and data analysis for
what people are referring to as the Cold War story.

      DR. SUGARMAN:  I'm Jeremy Sugarman.  I'm a physician
with advanced training in public health, as well as in
philosophy.  In this life I'm working as a Senior Policy and
Research Analyst.  I've been working on the ethical regulation of
research story.  In my other life I teach medical ethics in
medicine at Duke.

      DR. HERKEN:  I'm Gregg Herken.  I'm an historian at
the Smithsonian looking at Cold War issues.  I've been looking at
the plutonium injections and other early experiments.

      MR. WHITTEMORE:  I'm Gil Whittemore.  I'm a lawyer
and also an historian of science with an interest in the history
of radiation protection and also the development or the attempt
to develop a nuclear-powered airplane.  I have been working
partly on the Health and Human Services report and also partly on
the case studies, especially the Green Run case study.

      MR. DAVID:  Good morning.  I'm Jim David.  I'm a
researcher in the Department of Space History at the National Air
and Space Museum in Gregg's department.  I'm a Senior Research
and Policy Analyst with the Committee staff and am working on the
Cold War aspect of the story.

      MR. KLAIDMAN:  I'm Steve Klaidman.  I was a
journalist for 23 years with The New York Times, The Washington Post,
and the Herald Tribune, and then spent several years at the
Kennedy Institute of Ethics where I wrote a book on journalism
ethics with Ruth's husband, Tom.  I then went to the Institute
for Health Policy Analysis, where I wrote a book on media
coverage of health and science.

      I am in charge of public outreach and congressional
relations for the Committee and I've been working on a plan to
make information sharing among these groups as easy as it can
possibly be.  I'm also counselor to the Committee.

      DR. NEUMANN:  I'm Dr. Ronald Neumann.  I am a nuclear
medicine physician and atomic pathologist.  I'm serving as a
Senior Policy Analyst for the staff.  In the other part of my
professional life I'm Chief of Nuclear Medicine at the National
Institutes of Health and clinical professor of nuclear medicine
at George Washington University School of Medicine.

      I have served thus far on both site visits to the
agencies and have lent medical and scientific help in the
interpretation of the two of the case studies this morning, the
plutonium injections and the Cincinnati experiments.

      MR. KELLER:  I'm Lanny Keller.  I'm a journalist from
Louisiana and I'm going to be assisting Steve and Kristin in
public affairs.  I started yesterday at 2:30 and I don't know
much of anything yet, either.

      (Laughter.)

      CHAIRWOMAN FADEN:  Are we missing anybody?

      MR. GUTTMAN:  No.

      CHAIRWOMAN FADEN:  All right.  You can see, I think,
more clearly than from my abstract comments just how fortunate we
are.  We have some wonderful people, and I don't know how this
happened, but we'll just take it as a gift and say that's great.

      It also should be evident that we are still looking
to fill positions in sciences, and there are several Committee
members that are working closely with us to fill positions in
epidemiology, nuclear medicine, radiation biology, and health
physics.  If you have any suggestions, please, we are keen to
move quickly in those areas.  We have made progress and I think
by the next meeting, Committee meeting, we will have the science
side of the staff more fully fleshed out.  Right now Ron has been
bearing a tremendous burden, Jeremy assisting, but we
are -- Jeremy's led on the ethics side.  So we're really in need
of more people in the sciences, but we will get there.

      With that, I think we're ready to go onto our first
presentation, but we're going to switch the order.  So Ruth will
go first and then we'll have time for questions and answers, and
we'll just proceed apace.  Thank you.

      Would you be more comfortable coming up here?  I
think that might be the easiest.

      DR. MACKLIN:  I have the sense that what I'm going to
be saying is known to everybody in this room.  It's certainly
simple; I hope it's not simplistic, but I'll go ahead on the
assumption that maybe some people are not as familiar as most
people are with the ethical principles and human experimentation.

      The Belmont Report, which you received in the first
briefing book and were alerted to look at for this meeting, the
Belmont Report is a succinct statement of ethical principles and
guidelines for research involving human subjects, issued by the
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, hereinafter referred to
simply as the National Commission, in 1979.

      The Belmont Report is remarkable for its brevity and
its clarity.  However, like any document designed to be
comprehensive in scope, it leaves much room for interpretation. 
Also like any general document -- consider, for example, the
United States Constitution -- its application to particular cases
is neither simple nor automatic.  Broadly stated principles are
designed to give guidance, but as principles they are of
necessity general in their formulation.  This is one difference
between principles and rules of conduct.  As ethical principles,
they embody ideals that may not be fully realized in practice.

      The three basic principles articulated in the Belmont
Report were not invented out of whole cloth by the Commissioners. 
Each principle rests on a firm foundation in western moral
philosophy, and you'll forgive me, but I'll say a few words about
western moral philosophy.

      The first principle referred to in the Belmont Report
as respect for persons is rooted in the tradition associated with
the ethical theory of the German philosophy Emmanuel Kant.  Like
Kant's moral philosophy, the principle -- that is, respect for
persons -- focuses on autonomy.  The specific and most
fundamental application of this principle to the research context
is the requirement to obtain voluntary informed consent from
people before they may be enrolled as research subjects.

      As stated in the Belmont Report, and I quote,
"Respect for persons incorporates at least two ethical
convictions.  First, that individuals should be treated as
autonomous agents and, second, that persons with diminished
autonomy are entitled to protection."

      How do these relate to the philosophy of Emmanuel
Kant, who wrote nothing whatsoever about human experimentation? 
The key elements in Kant's moral philosophy are the inherent
dignity of every human being from which the notion of respect for
persons is derived, the idea that humans have a capacity for
self-rule, what we normally construe as autonomy and what Kant
referred to as self-legislating will.  And a third key element in
Kant's philosophy, a prohibition against treating human beings
merely as a means to the ends of others.  It's okay to treat
people partially as a means so long as they are also treated as
ends.

      These key elements can be understood in the context
of research, despite the fact that Kant himself never talked
about informed consent or other ethical concepts central to human
subjects research.

      One caveat is necessary in order not to misunderstand
the Kantian basis for this principle.  Kant formulated his theory
in terms of all rational beings, not specifically human persons. 
Although this does not matter much for our purposes, it's
important to see that the concept of rational beings refers to
the class of human beings as rational, as having a capacity for
self-rule.  If any particular human person lacks rationality, for
whatever reason, that would not disqualify the person as
deserving respect.  Rationality is to be construed as a species
characteristic, one that pertains to the class of human beings
even if some individuals lack that attribute.

      In the context of research and other human endeavors,
this is obviously very important.  It precludes treating
individuals who lack full rationality as inferior beings or as
ones who may be used as a mere means to serve the ends of others. 
Mentally retarded individuals, demented persons, those with
severe psychiatric illness are still persons deserving of respect
even though they lack autonomy.

      This consideration is what led the National
Commission to include the second moral requirement of the
respect-for-persons principle; namely, the requirement to protect
individuals with diminished autonomy.

      One writer has criticized the inclusion of these two
different ethical requirements under a single principle.  The
criticism states that either "persons are to be respected by
virtue of the value we place upon autonomy, in which case those
with diminished autonomy do not require our respect and, thus,
are not entitled to protection, or," the criticism continues, "it
is primarily the protection of individuals from harm that the
principle intends and it is also presumed that the individual,
when autonomous, is his or her own best judge of how to avoid
harm."

      So this critic of the incorporation of these two
different notions into the respect-for-persons principle -- this
critic contends that it's not clear that it's the good of the
research subject per se, by virtue of his or her autonomy, or
whatever, that one is enjoined to treat with respect.

      The simple reply, I think, is that it is the person
who is entitled to respect, whether that person has full autonomy
or diminished autonomy.  To use another piece of moral
terminology familiar to us all, persons have rights simply in
virtue of being persons.  One who has diminished capacity is
still a person and, therefore, a possessor of rights.  Respect
for persons, then, is an ethical principle designed to protect
the rights of human subjects of biomedical research.

      This explains why informed consent is an ethical
requirement even when the proposed research carries a very low or
virtually nonexistent risk of harm, as is true of some social or
behavioral investigations.  People can be wronged even when they
are not harmed.  To carry out perfectly benign studies on human
beings without their knowledge or consent, thus, wrongs them
because the subjects are being treated as a mere means to the
ends of others.

      The Belmont Report states that respect for persons
demands that subjects enter into research voluntarily and with
adequate information.  It's important here to emphasize that two
distinct requirements are embodied in this statement.  The
requirement that subjects be given adequate information relates
to the cognitive aspect of people's decisions.  Unless people
have sufficient understanding of what they're being asked to do,
their consent to participate is obviously not adequately
informed.  This means not only that appropriate information must
be conveyed to potential research subjects, but also that they
must comprehend what they have been told.  These elements relate
to the cognitive aspect.

      But there's also a volitional aspect to human
decisionmaking.  When a gunman approaches a victim and demands
your money or your life, the gunman is not offering a genuine
choice of options.  While in one sense it is true that the victim
voluntarily hands over his money, in another sense it's what
William James referred to as "forced choice."

      In discussing the requirement of voluntariness, the
Belmont Report uses the example of research involving prisoners
as posing a problem because of the apparent coerciveness of
prison conditions.  Perhaps the same might be said about research
involving military personnel.

      A somewhat different, yet still pertinent,
consideration arises when patients are asked to be subjects of
clinical research.  Ten years before the Belmont Report was
issued the philosopher Hans Jonas addressed this topic.  Jonas
wrote, "To the question who is conscriptable as research
subjects, the spontaneous answer is" -- and this is Jonas'
writing here -- "least and last of all the sick, the most
available source, as they are under treatment and observation
anyway."

      "That the afflicted should not be called upon to bear
additional burden and risk, that they are society's special
trust, and the physician's particular trust, these are elementary
responses of our moral sense," wrote Jonas.  Yet, he continues,
"the very destination of medical research, the conquest of
disease, requires that the crucial stage, trial and verification,
are precisely the sufferers from the disease, and their total
exemption would defeat the purpose itself."

      Jonas contended that being a patient makes a person
inherently vulnerable, and I quote:  "The patient's physical
state, psychic preoccupation, dependent relation to the doctor,
the submissive attitude induced by treatment, everything
connected with his condition and situation makes the sick person
inherently less of a sovereign person than the healthy one."

      Jonas concluded that the physician researcher is
obligated "to limit his undue power to the most important and
defensible research objectives" and, of course, to keep
persuasion at a minimum.  This is an obvious, yet critical,
point.  The more  persuasive the researcher, the less voluntary
is the patient's or subject's consent to participate.  To say, as
Hans Jonas did, that the sick person is inherently less sovereign
than a healthy person, is another way of making the point that
some people have diminished autonomy.

      This brings us to the second ethical conviction
incorporated in the respect-for-persons principle, as elucidated
in the Belmont Report.  As the report notes, not every human
being is capable of self-determination.  The capacity for self-
determination matures during an individual's life and some
individuals lose this capacity wholly or in part because of
illness, mental disability, or circumstances that severely
restrict liberty.  The report notes that some persons are thus in
need of extensive protection.

      Now this circumstance does not preclude the
enrollment of persons with diminished capacity or autonomy in
research, but it does require instituting mechanisms for their
protection.  A great deal of debate has surrounded the ethical
acceptability of carrying out experiments on subjects unable to
grant consent on their own behalf when the research does not
provide any direct benefit to the subjects themselves.

      One or two additional points about respect for
persons are worth noting before I go on to the other principles. 
Although the Belmont report focuses on the concept of autonomy
and elucidating the requirement of voluntary informed consent to
research, other important ethical concepts are related to the
principle.  The notions of privacy and confidentiality are the
most important examples.  To respect individuals is to respect
their informational privacy as well as their bodily integrity. 
This is why researchers may not pry into people's medical records
without their knowledge and consent.

      Similarly, the requirement that information gained in
the research process must be kept confidential also shows respect
for persons.  Unless a research subject gives permission to
reveal information learned by investigators, the investigators
are bound not to disclose that information to others, be they
family members, employers, insurance companies, the government,
or even in many cases other physicians.

      Recognizing that we do not live in a perfect world,
the federal regulations for the protection of human subjects
require researchers to state as part of the informed consent
process the extent to which confidentiality can or will be
maintained.  Although confidentiality of research records is not
absolute, there is a strong ethical presumption in favor of
protecting such information.

      Now so far I've been discussing only the ethical
principle that underlies the crucial requirement of obtaining
voluntary informed consent.  The second principle, termed
"beneficence," is treated as an obligation in the Belmont Report. 
The obligation, and I quote from the report, "to maximize
possible benefits and minimize possible harms."

      The report refers to the principle of beneficence as
also incorporating the ancient Hippocratic maxim:  do no harm. 
But this is problematic.  In the first place, do no harm can be
stated as a separate and distinct principle, which has been
termed in the technical jargon of biomedical ethics
"nonmaleficence."  Nonmaleficence is don't do bad, and the
beneficence is do good or do more good than harm.

      Now these are really two different principles, since
the obligations that flow from the injunction to do no harm may
differ considerably from those derived from the injunction to
maximize possible benefits and minimize possible harms.  As one
writer or commenter observes, the former principle -- that is, do
no -- I'm sorry.  The former principle, maximize good and
minimize bad, allows us to sacrifice the good of the research
subject for a greater aggregate good, but the latter
principle -- that is, the do no harm principle -- does not, or at
least the latter principle is ordinarily regarded as overriding
the former whenever they conflict.

      Secondly, and more important, the statement do no
harm is largely irrelevant both to the practice of modern
medicine and to the conduct of research.  Almost everything
physicians do causes some harm.  Drugs have potentially harmful
or uncomfortable side effects.  Surgery causes bleeding and
morbidity.  Rehabilitation causes pain.  Hormones administered
for prevention or therapy pose a risk of causing cancer.

      The only reasonable dictate to researchers and
clinicians practicing modern medicine is do more good than harm,
and this is the principle of beneficence.  If the respect-for-
persons principle is designed to protect the rights of research
subjects, the principle of beneficence is aimed at protecting
their welfare.

      This principle has its roots in a different branch of
moral philosophy from the Kantian theory that undergirds respect
for persons.  It is utilitarianism, best known from the writings
of the English philosopher, John Stuart Mill.  Mill's formulation
of the principle of utility, which he referred to as the greatest
happiness principle, holds that actions are right in proportion
as they tend to promote happiness; wrong as they tend to produce
the reverse of happiness.  By happiness is intended pleasure and
the absence of pain; by unhappiness, pain and deprivation of
pleasure.  Those are Mill's words.

      Utilitarianism is a species of a more general type of
ethical theory known as consequentialism, which holds that the
rightness or wrongness of actions, practices, or social policies
is a function of their good and bad consequences.  The
consequences of actions and policies can be assessed by values
other than pleasure and pain or happiness and unhappiness.

      One of the more common examples of a consequentialist
approach is the use of cost-benefit analysis in the economic
sphere.  In the domain of medical practice on biomedical and
behavioral research, the application of a consequentialist
principle is found in the mechanism of risk-benefit analysis.

      Federal regulations call upon IRBs to include in
their assessment of risk or harm more than the obvious physical
harms of morbidity and mortality.  Psychological, social, and
even financial harm can come to individuals as the result of
their participation in research.  For example, questions asked in
sensitive social and behavioral research may be intrusive and
cause emotional discomfort.  Also, people's interests can be
harmed when confidentiality is breached.  These observations show
that ethical considerations of privacy and confidentiality in
research relate not only to the respect-for-persons principle, as
I discussed earlier, but they also must be calculated in risk-
benefit assessments under the principle of beneficence.

      The form in which the Belmont Report states the
principle of beneficence imposes a stronger obligation on
researchers than would flow from a simple application of the
utilitarian principle.  Utilitarianism requires a preponderance
of beneficial consequences over harmful ones for an action to be
ethically right.  An action would not be morally wrong if it
resulted in a slight preponderance of good consequences over bad
ones, although another action would be more right if on balance
it yielded more good consequences or fewer bad ones than the
first action.

      The principle of beneficence, however, requires that
researchers and committees that review research have an
obligation to maximize possible benefits and minimize possible
harms.  It's worth pointing out that the Code of Federal
Regulations governing research -- this is 45 CFR that you will
learn so much about here -- the Code of Federal Regulations
contains a weaker provision than that stated in the Belmont
Report.  The criteria for IRB approval, institutional review
board approval of research, do require the IRB to determine that
risks to subjects are minimized, but there's no corresponding
requirement that anticipated benefits be maximized.  Rather, the
IRB must determine that "risks to subjects are reasonable in
relation to anticipated benefits, if any, to subject and to the
importance of the knowledge that may reasonably be expected to
result."

      Now it should be quite evident that making risk-
benefit assessments is a very difficult task.  In the first
place, while the risks always accrue to the subjects of research,
the potential benefits may accrue to the subjects and to others. 
Moreover, there need be no direct benefit to subjects at all. 
This tests the very meaning of the utilitarian ethical principle.

      Since there are always likely to be more people who
stand to benefit than there are subjects placed at risk in a
particular experiment, one of the interpretations of the
utilitarian principle yields the conclusion that a favorable
benefit-risk ratio is inevitable.  Now if that seems ethically
problematic -- and it is -- it's necessary to make a more refined
interpretation of risk-benefit analysis.

      The crude measure of the number of people placed at
risk and the number of people who stand to benefit is surely
inadequate, but to construct a more precise measure would require
a reasonably accurate assessment of the probabilities of
different possible outcomes, both the positive outcomes to
subjects to others and the negative outcomes in the form of harm
to subjects.

      Moreover, not only the probability, but also the
magnitude of benefits and harms must be calculated.  As the
Belmont Report observes, only on rare occasions will quantitative
techniques be available for the scrutiny of research protocols. 
The report acknowledges that the idea of systematic nonarbitrary
analysis of risks and benefits is an ideal, not realistically
possible to achieve in practice.  Still, the report notes, this
approach should be emulated insofar as possible.

      Now one commentator on the risk-benefit analysis has
offered several reasons why IRBs, institutional review boards,
have a difficult time making risk-benefit assessments.  This
commentator argues that the harm-benefit guidelines in the
federal regulations are notoriously ambiguous and contain a
marked bias for approval of protocols.  The ambiguity arises
partly because the key terms "harm" and "benefit" are wholly
undefined, and there's also the problem I just stated that review
boards have to compare the impact of research on individuals and
on society as a whole, but they're given no guidance in how to
balance the interests of a particular subject against the
interests of the collective.

      A further ambiguity lies in the meaning of the term
"reasonable" in the charge to the IRB that it must determine
whether risks to subjects are reasonable in relation to the
possible benefits of the research.  What appears reasonable to
one IRB may not be to another.

      Equally problematic is the fact that considerable
variation exists in the assessment of levels of risk from one
individual to another.  Even knowledgeable and experienced
members of the same review committee may make different
assessments of the level of risk of right heart catheterization,
of moving an in-dwelling catheter in place for several hours, of
lumbar puncture in newborns, or of placement of a measuring
device in the groin of a healthy person who is asked to pedal
furiously on a stationary bicycle until fatigue sets in.

      The other factor that makes the test of the IRB
difficult -- namely, bias in favor of approving
protocols -- relates to the fact that the guidelines allow
consideration of the long-range public good that might be derived
while expressly excluding consideration of possible public harms. 
This commentator notes that the asymmetry decreases the
likelihood that committees will find protocols wanting on risk-
benefit grounds.

       To guard against a blatantly unethical approach to
the admittedly difficult task of balancing risks and benefits,
the Belmont Report contains several limiting conditions.  The two
critical conditions are, first, that in order to be justified,
research can never involve brutal or inhuman treatment of human
subjects and, second, risks should be reduced to those necessary
to achieve the research objective.

      In light of these numerous methodological and ethical
problems that arise in applying the principle of beneficence to
the task of making risk-benefit assessments, it's necessary to
return to the requirement of informed consent.  A safeguard for
the protection of human subjects exists in the process by which
individuals can refuse to participate in research that they find
unacceptably risky.  For that safeguard to be operative, there
needs to be scrupulous attention to the process of informed
consent, and herein lies a major problem.

      The body that makes the risk-benefit assessment, the
IRB, only sees a consent document.  IRBs do not monitor -- at
least to my knowledge I don't know of any that monitors -- the
actual process of obtaining consent from potential research
subjects.   Informed consent is not a piece of paper the words
are written on, but rather a process of informing, ensuring that
the potential subject has understood the information provided and
accomplishing this process in a noncoercive manner.  As a means
of protecting the autonomy of human subjects of research, IRB
review of the consent forms researchers prepare leaves much to be
desired.

      Well, there's one more ethical principle to discuss
and I'll be very brief with this one.  This is the principle of
justice in research.  And here I'm going to do something somewhat
shameful, and that is quote some passages directly from the
product of the last committee that Ruth Faden chaired and Anna
Mastroianni worked on and I was a member.  This was an Institute
of Medicine committee that issued a report entitled, "Women in
Health Research," and I'm going to defend my laziness here only
by saying that I had a hand in preparing the chapter on justice
in clinical studies and it was so heavily edited and reviewed by
Anna and Ruth that I couldn't improve on that now.  So I'm going
to quote a couple of passages from the concept of justice and
research taken from "Women in Health Research."

      "The conception of justice embodied in the Belmont
Report is essentially that of distributive justice, a notion
pertinent to situations that call for the fair allocation of
society's benefits and burdens.  Fair allocation is best
characterized as equity.  That is, because research carries both
benefits and burdens, fairness requires that no one group,
gender, racial, ethic, or socioeconomic group receive
disproportionate benefits or bear disproportionate burdens of
research.

      "One aspect of justice in research is, thus, the
requirement of a fitting match.  The population from which
research subjects are drawn should reflect the population to be
served by the actual or projected results of the research.

      "The chief concern over the past several decades has
been that some groups, such as incarcerated men, have been
overstudied.  The Belmont Report addressed this concern by urging
that" -- and now I'm quoting from the Belmont Report -- "`The
selection of research subjects needs to be scrutinized in order
to determine whether some classes -- for example, welfare
patients, particular racial and ethnic minorities, or persons
confined to institutions -- are being systematically selected
simply because of their easy availability, their compromised
position, or their manipulability rather than for reasons
directly related to the problem being studied.'

      "Distributive justice," which is this fairness-equity
criterion, "is only one of several different conceptions of
justice.  Two examples of other conceptions of justice that may
apply to the work of this advisory committee are retributive
justice and compensatory justice.  Retributive justice is the
notion that relates to punishment for wrongdoing, with the most
prominent context in any society being the criminal justice
system.

      "The punishments meted out by the Nuremberg tribunals
to the Nazi doctors were one instance of retributive justice in
the domain of human experimentation.  Another example is the
sanctions that are currently being imposed by the National
Institutes of Health on researchers who are found to have engaged
in scientific misconduct of one form or another.

      "A third notion" -- we have distributive justice; I
just mentioned retributive justice, and a third notion is
compensatory justice.  "The notion of compensatory justice goes
beyond that of fairness in distribution in an attempt to remedy
or redress past wrongs.  An example from the history of human
subjects research is that of the monetary payments that were made
to survivors of the Tuskegee syphilis study or to their relatives
to compensate them for the harm or wrong done by the study."

      Well, my conclusion here:  I have not ventured in
this brief presentation to address the question of the validity
of retrospective application of ethical standards governing
research that are accepted today, but I conclude with the
following brief points:

      There is a difference between the particularity of
moral rules and the generality of ethical principles, such as
respect for persons and beneficence.  There's also a difference
between specific procedures governing research, such as IRB
review and others specified in the Code of Federal Regulations
and the ethical standards that such procedures are designed to
embody.  Although the ethical and legal doctrine of informed
consent to research may be relatively recent, the ethical
principle of respect for persons is of longstanding duration and
is applicable in broad areas of human life outside the biomedical
arena.  Similarly, physicians have been accustomed both before
and after the advent of scientific biomedical investigations to
make judgments about the beneficial and harmful consequences to
their patients of various maneuvers.

      Whether ethical principles are universally applicable
is a matter of ongoing debate, but it is still a meaningful
question to ask whether the conduct of thinking people should be
subject to ethical evaluation in light of fundamental ethical
principles, even when specific rules conforming to those general
principles are absent.

      Thank you.

      CHAIRWOMAN FADEN:  Thank you very much, Ruth.  Why
don't you stay for just a few minutes?

      DR. MACKLIN:  Oh, okay.

      CHAIRWOMAN FADEN:  This is a treat actually, as I
think all the presentations will be.  We're going to have some
time for questions, about five or ten minutes, from the Committee
members of Ruth.

      No?  No questions?

      DR. MACKLIN:  Either it was fully opaque or totally
clear.

      (Laughter.)

      CHAIRWOMAN FADEN:  We've got a question from Duncan
and then a brief comment.  But Duncan's right, if you can
continue to remember to reach for the mike, I know it's
inconvenient, but it facilitates transcription.

      DR. THOMAS:  I guess I just want to pursue the
concept of distributive justice and perhaps to bring it down to
the things that we're talking about here, its application perhaps
to the Cincinnati experiments.

      I guess the question is:  does a physician or an
institution which serves primarily a minority population or an
underprivileged population, let's say a charity hospital -- is it
ever considered justifiable to do research in such an
institution?

      DR. MACKLIN:  Sure.  Remember what the principle
says.  The principle doesn't rule out -- and remember it's a very
general principle -- the principle does not rule out research on
particular classes or groups of people.  What the research
requires is that -- I mean, what the principle requires is that
those who are subjected to the burdens, perhaps the risk of
research, also be ones who are likely to benefit from the
research as a class.

      Say, for example, if poor people -- and minorities
may be in that group because they may be more highly represented
among poor people -- if poor people and/or minorities are the
subjects of research because they're in charity hospitals or
academic hospitals that are located in parts of the city or
public hospitals where those people come, and that's where the
academic medical center is, if they are used as the subjects of
research but when the applications of that research become
available and they're uninsured or underinsured, and don't,
therefore, have the benefits of the treatments that are developed
as a result perhaps down the line or if not those individuals
necessarily, but members of the same class -- so the principle of
distributive justice requires that if one class is studied, that
that class also receive the benefits of whatever positive results
accrue to the research.  So that's one example.

      Now the question here, it's a little tricky because
the principle of justice, again, as I said, these require a lot
of interpretations.  The question is:  what is the right unit to
look at?  Is it a hospital?  Is it all charity hospitals?  Is it
all research done everywhere on poor people regardless of where
they are, and you have to weigh all of that against the benefits? 
So the principle requires some interpretation in order to
ascertain when you actually have achieved a balance.

      Now I think a very good example of the violation of a
principle is the use of incarcerated individuals for many years,
most of whom were normal, healthy volunteers to whom very bad
things were done.  I mean, they were deliberately given hepatitis
and all kinds of other things, and then they were given a little
money for cigarettes, you know, and the whole question of prisons
being inherently coercive environments, thereby not enabling them
readily to say no, is what fed into that discussion.  But as a
group -- namely, prisoners -- it could truly be said that
prisoners as a group were not benefiting correspondingly from the
research in the way that the group of prisoners was burdened by
the research.

      I don't know enough about the history or details of
the use of other institutionalized persons, such as people who
are mentally retarded people in institutions or people who have
long-term psychiatric illness, but the National Commission -- one
of the reports that the National Commission issued was a report
on research on those institutionalized as mentally infirmed,
thereby noting that that group requires special protections
because they also might tend to be among the overstudied group.

      Now I don't know if I answered your question, because
you wanted it related specifically to Cincinnati.  My answer is
in general; it's not clear that if you picked any one hospital
you're going to be able to use this principle and get an answer.

      DR. THOMAS:  I guess I have read in places like the
report for the Cincinnati experiments that the IQ ratio SES
distribution of their patients was in no way unrepresentative of
the general population which that population served, and that was
taken as a defense on this particular criterion.  It doesn't seem
to me per se to be a defense.

      DR. MACKLIN:  Well, it's not a defense if you -- in
other words, the question is:  was this exploiting a group;
right?

      DR. THOMAS:  Right.

      DR. MACKLIN:  They were trying to answer that
question:  was this exploiting a group?  To answer that question,
you can look at this group as being representative and say, look,
they're no different from any other group in society; it was
"representative" of society; therefore, we were not exploiting
that group.  That may be an adequate or reasonable answer to that
question, but that's not the justice question.

      The justice question is whether that group being,
generally speaking, poorer or having less access, not having
access to wealthy private physicians in Cincinnati, whether that
group or the group they represented would bear the benefits,
receive the benefit.

      CHAIRWOMAN FADEN:  Okay, we've got a procedural issue
here.  Ken, you've got a question?  Jay wants to make a comment. 
Ron, did you want to speak right to this point?

      DR. NEUMANN:  No, I actually wanted to ask a question
that's somewhat pertinent to it.

      CHAIRWOMAN FADEN:  Is it on this same issue?

      DR. NEUMANN:  A bit.  My question, if I may go -- 

      CHAIRWOMAN FADEN:  Go ahead.

      DR. NEUMANN:   -- is:  is there a concept of additive
disadvantage in terms of studying populations?  For example, if
you begin with a process of being perhaps less sophisticated for
lack of education, are now also ill and come from a traditional
disadvantaged group, are those things thought of as additive or
would they be looked at as independent in terms of deciding
whether or not experimentation on that group of individuals might
or might not be appropriate?

      DR. MACKLIN:  Well, that's a very good question. 
You're asking hard questions.  There's no answer in the books,
general answer in the books or in my head.  One would have to
look at the nature of the disadvantage, the particular
circumstance, and, indeed, whether the group that may be
disadvantaged by virtue of sickness might actually stand to
benefit by the research maneuver or by the care.

      Now one argument that's sometimes given is that
patients who enter what are often public hospitals or university
hospitals and are, therefore, more available for research and are
invited to be in the research are getting better care.  I mean,
now this is a comment about our health care system, but they're
getting better care at the hands of very knowledgeable and expert
physicians who are monitoring them or looking at their physical
condition and, also, by the way, doing some clinical
investigations, but they're getting care that they would not
otherwise get were they not in this hospital that provided these
services.

      So the question of being additive, I don't think
there's a simple answer, but to the extent that you might find
multiple disadvantages, a coercive environment, a diminished
autonomy, then I think you're looking both at the informed
consent aspects and the question of justice.

      CHAIRWOMAN FADEN:  We have a problem, obviously, with
time.  So I think what -- I've acknowledged Ken and Jay; I think
we need to stop there, but let me just reassure everybody we're
going to be continually revisiting the themes that were
introduced over the life of this Committee.  So please don't -- I
know there's some level of frustration that we can't explore all
of the issues in their fullness.  We will by the time we've
finished have discussed these issues probably more than anybody
ever wanted to.  So bear with us.

      Ken and then Jay, and then we must go on.

      MR. FEINBERG:  What test does one apply in deciding
whether the principles that you've articulated have been
violated?  For example, analogizing to the model penal code of
America, does one apply an objective test?  What did the doctor
or scientist reasonably believe?  Would a doctor or scientist
reasonably have believed there was informed consent?  Is that an
objective standard or is it a subjective standard?  What did that
doctor or that scientist actually believe, whether it was
reasonable or unreasonable?  Did the doctor subjectively believe
that there was informed consent or is there a hybrid?  What did
the doctor or the scientist reasonably believe in the situation
that the doctor or the scientist found himself or found herself
in?

      I mean, how does one go from these fundamental
principles to an application in an attempt to decide whether or
not there's been a violation of the principles?

      DR. MACKLIN:  Well, that's a good question.  I'm
going to try to make the answer brief.

      It requires a lot of -- there are several points to
your question, and that's why it's hard to give a single answer
because you've asking about objective and subjective, but there
are also other elements.

      First, there are, as stated both in the federal
regulations and a little more generally in the Belmont Report,
criteria for the informed consent.  We have to look at each
principle separately, by the way.  I mean, we've got two
principles here, the risk-benefit one and the informed consent. 
I think you just addressed the informed consent.

      There are objective criteria set out in the Belmont
Report for what elements must be disclosed.  So that's a question
of what must be disclosed.  If a physician failed to disclose
those things -- and, of course, you need the evidence that the
physician did or did not, but you get the piece of paper which is
the consent document.  If it doesn't mention all the -- not all,
but an adequate -- the standard of disclosure is also an issue,
but let's set that aside.  If key elements that should be
included in the disclosure, that should be disclosed in the
informed consent, risks, for example, that have a high magnitude
or a high probability are not disclosed, then you've got an
objective standard.  They are not there on the form, et cetera,
and, of course, there's this other question of what goes on in
the consent process.

      There's also the question of whether the subject is
adequately understood, and that can be a subjective matter as
well as an objective matter.  One could take the trouble and go
through steps to ascertain whether subjects have, in fact,
understood what they've been told.  Most people don't go through
those things.  So the doctor might say -- here's where the
subjective part comes in -- "I believe the subject understood.  I
disclosed all these things.  I believe the subject understood and
heard them."  And the subject then says, "The doctor didn't tell
me that" or "I didn't understand that," et cetera.  So there's
that kind of problem, but I mean the test there might have to be
subjective in the level of understanding, but in terms of the
elements disclosed you truly have to use the objective test.

      I think we're in worse trouble with subjective and
objective applications on a reasonable person standard when we're
looking at risks and benefits, and I just alluded to that very
briefly.  I mean, you've got the researcher, physician-
researcher's beliefs in risks that reasonable to subject the
patient to; you've got what the subject might think is
reasonable -- and, of course, the subject has the right to
refuse -- and then you've got the IRB making these risk-benefit,
you know, balancing.  That is entirely subjective, and the
research, if you look in the Code of Federal Regulations, there
are these gradations:  minimal risk, a minor increase above
minimal risk, increases of risk above minor increases above
minimal.

      If you asked IRBs to look at procedures, the example
I gave, right heart catheterization, et cetera, they'd be all
over the map.  There have actually been a few studies done in how
physicians or experienced clinicians assess levels of risk.  So
it's a very complicated question.  You ask, what is the test for
applying the principles, and I think you need both some empirical
evidence in some cases and some reasoned analysis if you're
presented with a case and ask, was this principle violated?

      CHAIRWOMAN FADEN:  Thank you, Ruth.

      Jay, did you want to -- 

      DR. KATZ:  Yes, I'll be very, very brief.  You know,
we've been privy to a wonderful presentation of the complexity of
principles and the application of principles, and we will surely
discuss it.  But the one issue that I want to raise is, when Ruth
started out -- and she's an ethicist from whom I've learned much,
and I'm not an ethicist; sometimes I don't know who I am
(Laughter), but when she argued that the Belmont Report is
remarkable for its brevity and clarity, I really cannot agree
with her or I only agree in half with her because the Belmont
Report, in my view, is remarkable for its brevity and for its
unclarity.

      (Laughter.)

      We need to study it very, very carefully.  It is
unclear for one major reason, that it constantly and in a
dizzying way goes back and forth between talking about competent
patients and incompetent patients when interpreting the
principles, and that at least to my mind creates a great deal of
confusion.

      I've discussed it a little bit in my latest article. 
I just, in order to be brief, would read one paragraph, a small
paragraph that I think illustrates this, and it's important that
all of us read the Belmont Report carefully and come to our own
conclusions.

      I quote, "The examples given for justifying
invocation of the principle of beneficence" -- let's see if I
take my glasses off -- "addresses only vulnerable populations. 
Yet, in setting forth three principles for the general conduct of
research and then appealing to such great terms of art as
protection from harm and securing well-being for invoking the
beneficence principle, this can readily create the impression
that with competent subjects, too, autonomy may at unspecified
times have to yield to beneficence.  Respect for persons deserves
a more unequivocal or at least a more precise formulation."

      And it's that issue which we'll have to confront in
most of our deliberations because we will, by and large, deal
with patients who are competent, and then the question arises: 
to what extent do we have give primacy to autonomy and to respect
for person?  And the principles of beneficence and justice cannot
be invoked in these kinds of situations, and this is an important
ethical issue and legal issue and societal issue which we'll have
to confront.

      CHAIRWOMAN FADEN:  Ruth will have the last word.

      DR. MACKLIN:  Yes, I've just revised my presentation
to read, "The Belmont Report is remarkable for its brevity."

      (Laughter.)

      I think the analysis that I gave in the last half
hour demonstrated some of the lack of clarity.

      DR. KATZ:  Exactly.

      DR. MACKLIN:  And I would only say, in defense of
what I originally wrote, that anybody can read the Belmont
Report; it's not obfuscating, but it's confusing.  The clarity
lies in stating these ethical values and making clear to people
who are not philosophers or don't know Kant and Mill just what
values they are and how they are rooted in our common tradition. 
That's the part that's clear.  These are not esoteric values or
ones that are so abstruse that it requires philosophical study,
like it does to read Emmanuel Kant.  So that's really what I had
in mind, but the complexity and the confusion that can arise from
principles that have to be balanced or put in a priority, I
entirely agree.  So I stand corrected in the use of that word.

      Thank you very much.

      CHAIRWOMAN FADEN:  Thank you, Ruth.

      We are going to proceed apace.  Just so you'll know,
we're already considerably behind schedule.  If we keep going,
there will be no break.  If we keep going, there will be lunch. 
So just know that at the pace that we're going, we just may never
have to attend to biology.

      Henry?

      DR. ROYAL:  I'm sure you're all wondering what the
technical difficulty was.  I was waiting for a Geiger counter
because I brought some things that were radioactive because I
think if we're going to talk about radiation, it helps to see and
touch and feel some real radioactive material.

      If you look at the tab -- I guess it's Tab D -- the
outline for this chart using Tab D, I'm pretty much going to
follow that outline.  In addition is a paper about the health
effects of low-level radiation written by Rosalyn Yalow.  Rosalyn
Yalow is a Nobel Prize winner and has been very interested in the
health effects of low level radiation.

      If you read that paper, you should understand that it
really sort of represents the middle-of-the-road view in the
radiation community about what the effects of radiation are. 
Just as we heard from Ruth Macklin that there's a bias in
medicine looking at the benefits of research as opposed to the
potential harms, people would argue that people who work with
radiation have a bias toward the benefits of radiation.  So I'm
presenting Yalow's paper as representing a middle-of-the-road
position for people who work and who are knowledgeable with
radiation, and I'll leave it up to you to make the judgment as to
whether or not there's any bias involved.

      The third paper that happened to end up in that tab
is from Stannard's text, and it's what we know about plutonium. 
So it's certainly relevant to the plutonium injections.  It's not
especially relevant to the talk that I'm going to give.

      Are the slides on?

      CHAIRWOMAN FADEN:  Who's doing the slides?  Can
somebody lower the lights?

      DR. ROYAL:  It's probably the automatic advance
that's on one of those slide projectors because it's working on
its own.  Could you advance it to the first slide on that
righthand projector which is not projecting anything?

      The first thing that I was going to discuss is the
word "radiation" and what the word "radiation" means.  In and of
itself, it's very confusing because radiation, the first dividing
point is whether or not we're talking about ionizing radiation or
nonionizing radiation.

      CHAIRWOMAN FADEN:  We need to go back a slide.

      DR. ROYAL:  The first issue is whether it's ionizing
or nonionizing radiation.  Ionizing radiation is much more
energetic that nonionizing radiation, and you can see that x-ray,
gamma rays, neutrons, and alpha rays, beta rays, those are all
forms of ionizing radiation.  Nonionizing radiation is radiation
like radio waves, microwaves, infrared, ultraviolet; even ambient
light is a kind of radiation.

      So the first issue to talk about when you're talking
about the health effects of radiation is whether it's ionizing or
nonionizing radiation.  The experiments that this Committee has
been concentrating on really have to do with ionizing radiation,
not nonionizing radiation, at least the three case studies that
we're talking about today.

      Then even if you know that it's ionizing radiation,
there are other issues which are important.  First of all,
whether or not that ionizing radiation is due to nonparticulate
radiation or whether it's due to particulate radiation.  As you
can see from the slide, x-rays and gamma rays are nonparticulate
and neutrons, alpha rays, and beta rays are particulate, which
means it has some mass.  So, unlike light, which has no mass, the
neutrons, alpha rays, and beta rays actually have some mass
associated with them.

      The reason that that's important is it determines how
the energy, the potentially damaging energy of the ionizing
radiation, is deposited in the body.  Nonparticulate radiation,
which has no mass, penetrates the body, so it's able to reach
deep structures like the bone marrow, which is a radiation-
sensitive organ.

      On the other hand, particulate radiation, as you can
see on the far righthand slide, can be further subdivided and the
charged particulate radiation, the alpha rays and beta rays, are
nonpenetrating.  So plutonium, which is a pure alpha emitter,
does not penetrate even the dead layers of skin.  So if I were
holding plutonium in my hand, it would not hurt me because the
energy that it would deposit would get deposited in the dead
cells, the surface of my skin.  It would never reach any live
cells.  Plutonium is only a problem if it gets into your body in
contact with living cells.

      The other reason that particulate kinds of radiation
are important is neutrons which have no charge are a penetrating
form of radiation, but they cause more damage than x-rays or
gamma rays.  So if you deposit the same amount of energy with
neutrons as you did with x-rays or gamma rays, you'd get a bigger
biological effect, typically maybe 10 times the biological effect
with neutrons when compared with x-rays or gamma rays.  When we
talk about the units of radiation, you'll see that the difference
between a rad and a rem is just how that energy was deposited in
the body.  For neutrons, a rem is twenty times more than a rad,
but for x-rays and gamma rays they're really equivalent.

      Another confusing term is what is radioactive; what's
the difference between radiation and radioactive?  Well,
radiation is the energy that's emitted.  Radioactive means that
something spontaneously emits radiation.  So if we have an x-ray
machine, an x-ray machine is not radioactive because if I pull
the plug out, it will no longer emit radiation.  On the other
hand, if we have something which is radioactive, it will
spontaneously emit radiation.  This brings me to the show-and-
tell part.

      So this is a Geiger counter and you can hear it
clicking.  The reason that it's clicking is because we live in a
radioactive world and we're all exposed to radiation from natural
sources.

      Now one of the reasons why we use radiation in
medicine is we're able to detect very small amounts of material,
material that we would be unable to detect using other
techniques.  And just to show you that, I have something
radioactive in my pocket.  If I hold the Geiger counter up to it,
you can see that I have no trouble detecting that radioactive
material.

      Now what is it that I have in my pocket?  This is a
Coleman lantern mantle.  If you go camping and you tie it on the
end of a propane lamp, it burns with a bright white light.  The
reason it burns with a bright white light is because the propane
heats up the thorium atoms, which are an integral part of the
Coleman lantern mantle.  By heating up those electrons of a
thorium atom, it's those electrons falling back down to their
unexcited state that gives off the bright white light.

      Normally, if you were to burn propane, it would burn
with an orange or a blue flame.  The reason it burns with a white
flame when you have a Coleman lantern mantle is because you have
the radioactive thorium atoms in your Coleman lantern mantle and
those get heated up, and it's their electrons falling back down
to their unexcited state that gives the bright white light.

      So those of us who work with radiation, one of the
things that we feel is that it's better to work with something
that's radioactive and a carcinogen than it is to work with
something, some other biological hazard.  The reason is I can
tell in an instant whether or not I'm working with something
radioactive or whether there's radiation in the room, and I can
tell how much.  If there were a biological hazard like hepatitis
virus, I would have no way of knowing whether or not I was being
exposed or not being exposed.

      One other thing I wanted to demonstrate is I have
some radioactive material on this plate.  I need a bigger table. 
One of the experiments that we heard about was soldiers crawling
through radioactive sand.  When you get radioactive dirt on the
outside of you like that, that's called external contamination. 
External contamination is not such a problem when you're talking
about the health effects of radiation because to get rid of that
problem, I can just brush it off.  Once I brush it off, it's no
longer exposing me to radiation and it's not such a big problem.

      On the other hand, if I got that radioactive dirt
inside of me, then I would be internally contaminated and that's
a much bigger problem because I can't brush off that stuff that's
inside of me.  So there's internal contamination and external
contamination.

      Now some of you are probably thinking that I'm pretty
silly eating radioactive material, and you're absolutely right, I
would be silly if I was doing that.  That's just sugar that I was
eating, but this plate is radioactive.  I always like to show
that this plate is radioactive because there's usually someone in
the audience who has plates like this at home and then they give
them to me.

      (Laughter.)

      You can hear it's considerably more radioactive than
the Coleman lantern mantle.  The reason it's radioactive is it
has uranium in the glaze.  Uranium was first mined as a dye.  It
was not mined because it was radioactive.  Uranium, as you know,
when they process it, is called yellow cadmium, and often orange
glazes contain uranium in them.  This is called Fiesta Ware.  If
you go to your flea market, they'll probably charge you $15 or so
a plate.  Fortunately, I don't have to pay for my plates.

      (Laughter.)

      Okay, so you've seen a little bit about what
radiation is.  Let's talk about how much radiation.  The units
that we'll need to become conversant in are Roentgen, rad, and
rem.  So one of the reasons why they're confusing is they all
start with "r."

      A Roentgen is the physicist's measurement of how much
radiation there is.  It's the number of ionized pairs that are
produced in air.  So it's a measurement that is done in air. 
There's no body around to measure a Roentgen.

      A rad is how much of that radiation is actually
absorbed per gram of tissue.  So it's the amount of energy that's
deposited per gram of tissue.  I want to point out that the per
gram of tissue part of it is very important because some people
think that one rad to your finger is worse than one rad to your
whole party because they think that if you give the entire rad to
the finger, that that's much worse than if you spread that rad
over the whole body.  But if you know that it's per gram of
tissue, you actually know that we're talking about depositing
less energy; the total amount of energy that's being deposited is
much less if it's just your finger than if it's your whole body. 
So it's per gram of tissue.

      And then the rem adjusts that energy that's absorbed
per gram of tissue according to its biological effect.  As I said
when we were talking about neutrons, neutrons have a greater
biological effect per the same amount of energy deposit in the
tissue.  So a rad of neutrons is about 10 to 20 rems of neutrons. 
For x-rays and gamma rays, the quality effect of going between
rads and rems is one.  So rads and rems are the same for x-rays
and gamma rays, and those of us who work in the medical
environment and who work almost exclusively with rads, with gamma
rays and x-rays, are very sloppy about how we use the word "rad"
and "rem."  We use them interchangeably.

      Another important unit is the Curie.  Now the Curie
tells you how much of a radioactive material you have.  So it's
not a measure of radiation.  It's the measurement of how much
radioactive material you have, and that measurement is expressed
in disintegrations per second.  The reason it's expressed in
disintegrations per second is that's what you actually measure
when you're trying to figure out how much is there.  You're
measuring the disintegrations per second.  So in radiation
sciences, the measurement of how much is there is disintegrations
per second.

      If you try to figure out what the radiation dose is
for a Curie of material or a milli-Curie of material, it's very
complicated.  You can't easily go from disintegrations per second
to dose, and the reason you can't is because the actual exposure
or dose depends on the distribution of the radioactive material,
what's its half-life is, both its physical half-life and its
biological half-life, and also how does it decay.  Does it decay
by giving off gamma rays?  Does it get decayed by giving off
alphas or betas?  So going from Curies, which you use all the
time, to dose is not straightforward.

      To give you a little bit of an idea of what Curies
mean, this Coleman lantern mantle contains about 35,000 pico-
Curies or 35 nano-Curies of thorium.  When we inject
patients -- I'm a nuclear medicine physician -- when we inject
patients with a technetium-labeled isotope, we typically inject
milli-Curie amounts of activity.  When President Bush was treated
for his hyperthyroidism, he was given milli-Curie amounts of
I131.  So milli-Curie amounts of radioactive material typically
will be used for diagnostic and sometimes therapeutic studies.

      Now dose everyone thinks ought to be a real easy word
to deal with, but dose is a very confusing word.  The reason that
dose is a very confusing word is there are literally 20 or 30
different kinds of doses.  So, for example, someone might talk
about the dose and be referring to the amount of material the
patient was injected with, somebody might be talking about the
radiation dose to the skin, and the radiation dose to the skin is
often considerably larger than the radiation dose to deeper
structures because the radiation doesn't totally get to the
deeper structures.  They might be talking about midline dose,
organ dose, et cetera.  So lots and lots of different kinds of
doses.

      One of the reasons people get confused very easily
about doses is they'll read a dose in one place and it will say
it was 100 millirems and they'll read a dose somewhere else and
it will say it's 10 millirems and they won't know which dose to
believe.  Often the problem is that they're talking about two
different kinds of doses.

      Now what kind of radiation doses -- what are the
range of radiation doses that we're likely to talk about?  Well,
first of all, with cancer therapy, so with radiation therapy,
typically, people are exposed to 5,000 rems or, in the units that
are used here, 5 million millirems.  A millirem is 1/1000th of a
rem.  So that's a typical cancer treatment dose.

      It's kind of interesting, if you look on the next
line, that the whole body dose, which will kill 50 percent of
people in 30 days, if you were exposed to this dose, is 350 rads
or rems.  The reason that the cancer therapy dose is so much
bigger and that it doesn't kill the patient is because it's
localized to only part of the body; it's not a whole body dose;
plus, it's often fractionated which decreases the effects of the
radiation therapy.

      In terms of that number, 350,000 millirems as being a
lethal dose of radiation, that's without any treatment.  If we
were to treat people, we probably -- the LD 50 would probably be
600 or 700 rems.

      Now one of the things that I suspect this Committee
will look into at some point is we currently use whole body
radiation as a form of treatment for many different kinds of
cancer, and when we start talking about those whole body
radiation doses, they're usually in the thousand rem range.  So
they're greater than those 350 rems that's on the slide.  The
reason for that is when whole body dose is used in that context,
radiation-sensitive organs are protected in some way.  So it's
really not a uniform whole body dose that's getting the 1,000
rems as treatment for the leukemia, or whatever.  So, again,
that's a very important concept to get across, and the concept is
that the chances that someone really has a uniform whole body
dose is very unlikely.  So that these are all sort of ideal
constructs as opposed to real numbers.

      The time at which you become acutely ill from
radiation, the kind of dose that might cause some symptoms, is
100 rems.  Typically, you get nausea, vomiting, those sorts of
things.  Then when you have a cardiac catheterization, the skin
dose might be as high as 50 rems, especially if it involves some
treatment like a balloon dilation of coronary artery.

      The occupational limit each year is 5,000 millirems. 
The administrative goal at many universities is to not have
anyone exposed to more than 2,500 millirems.  Then we get down to
diagnostic examinations, diagnostic examinations and abdominal
CT, the local radiation dose is about 2,000 millirems or 2 rads. 
Whole body dose for members of the public, the limit is 500
millirems.  Whole body dose that we're all exposed to each year
from natural sources of background radiation is 300 millirems. 
If you have a chest x-ray, the local radiation dose is 20
millirems.  If you fly across the country, you get an extra 2
millirems.  If you live in Denver, Colorado, you get an extra 100
millirems a year from living in Denver.

      So I think the natural background, we have a
tendency, those of us who deal with radiation, to try to put
radiation doses into perspective related to natural background,
compared to living in Denver versus living in St. Louis, where
you get 100 millirems more per year in Denver than you do in St.
Louis, if you assume a 70-year lifespan, then we're all exposed
to 21 rems of radiation during a lifetime.

      I think a slide jammed on that righthand projector. 
So if you could advance that two slides, I'd appreciate it.

      Now I mentioned that we're all exposed to natural
sources of radiation.  What we're going to look at now is the
natural sources of radiation as well as the manmade sources of
radiation.  Just to confuse you, the units on this pie
chart -- yes, it's the other slide that I want you to advance to;
there may be a slide jammed in it.  Forward two.

      In terms of sources of radiation, the units that are
on this slide are milli-Sieverts.  Milli-Sieverts are meters
versus feet.  It's an international unit.  So 2 milli-Sieverts is
200 millirems, and you can see from that pie chart that 200
millirems of our exposure each year is from radon; 39 millirems
is from internal exposure; 28 is from radioactive
materials -- that's in the dirt; 27 is from cosmic radiation, and
then 63 is manmade.

      If we get the manmade pie on the righthand side, what
you'll see is most of the manmade radiation is from diagnostic
use of radiation in medicine.

      I think it's back one slide from there.  Why don't we
try going forward two slides then?

      In terms of the manmade radiation, most of it is from
diagnostic procedures.  About 40 or 50 millirems is from
diagnostic x-rays, another 14 millirems from nuclear medicine. 
Consumer products like fire detectors and Coleman lantern mantles
account for another 10 millirems or so.  The thing that's very
interesting about this pie chart is the things that we hear about
so much like nuclear power plants, fallout, and those sorts of
things, actually form a very small fraction of our radiation
exposure.

      One of the things that nice about using two slide
projectors is that you are twice as likely to have something go
wrong.

      (Laughter.)

      Perceived effects of radiation, before we get into
what we know about the effects of radiation, I think it's very
important that we talk about the perceived effects of radiation. 
Most of us learned about radiation watching Sunday morning
cartoons.

      Let me see if I can advance that slide from here. 
That's all right.  I've told you as much as I want to tell you
about the manmade sources.

      In terms of perceived effects of radiation, here's a
quote from National Geographic.  I thought it was appropriate given
that we're so close to the National Geographic Society.  It says,
"In the ultimate test of human judgment, radiation gives us the
power to enhance the world or destroy it."

      If you asked most people in the public about
radiation, there's no question in their mind that radiation is
dangerous.  It's a very black-and-white issue.  To most people,
radiation is a monster lurking in the background.

      Now why do we have these feelings about radiation? 
Well, one of the reasons is from the time we were 3 or 4 years
old, we have been told about the effects of radiation. 
Spiderman -- and some of you might have noticed that I'm wearing
a Spiderman tie because he certainly is one of my heroes
(Laughter) -- he became Spiderman because he was bitten by a
radioactive spider.

      The Hulk became the Hulk because he was exposed to
radiation from gamma rays.  Here's the Hulk.

      One of the lesser-known people is on your lefthand
side, but she actually is one of my favorite people, and I know
that those in the back can't see it.  So I'll read to you what it
says.  It's about someone by the name of Atomic Mary and she
lived next to a leaky nuclear power plant, and those of you who
can see the last frame on the right notice that she developed a
keen sense of smell.

      (Laughter.)
      And then for those of you who want to be up to date
about what's going on in the nuclear power industry, you can turn
onto Homer Simpson and hear about radiation.

      So my point is that if you look at the effects of
radiation that the public hears about, it's not surprising that
people have a very different opinion about what the effects might
be compared to what the scientifically-accepted effects are.

      Our last meeting I brought in a standards textbook
which you remember was very thick.  There's really an incredible
amount of material about the effects of radiation.  Each four,
five, or six years, what we know about the effects of ionizing
radiation are summarized by a National Academy of Sciences
committee called the BEIR Committee, which stands for Biological
Effects of Ionizing Radiation.  The most recent publication is
shown on your left and was published in January of 1990.  Most of
the things that I presented about the scientific effect of
radiation are really a summary of what you can find in BEIR V.

      Radiation effects are really divided into two major
categories of effects, deterministic effects and stochastic
effects.  Deterministic effects are effects that you see with
high doses of radiation.  So I give you an example of what a
deterministic effect would be.

      If I exposed my hand to high doses of radiation, it
would turn red due to the radiation exposure.  The amount of
redness that I get will depend on how large the dose was.  So
deterministic effects typically have a threshold; that is, if I
give my hand a small amount of radiation, it won't get red.  The
severity varies with the dose; that is, the redness, the damage
to my skin will get worse and worse as the dose increases.  It's
really seen with only high doses and it occurs in a high
percentage of the population that's exposed.  As a matter of
fact, I can -- 100 percent of the population will get skin
reddening if the dose is big enough.  So those are the
deterministic effects and we'll talk about what other effects
besides skin reddening might be.

      The stochastic effects are what we worry about when
we're talking about low doses of radiation, and those are things
like cancer, genetic effects, and effects on the fetus.  The
stochastic effects are thought not to have a threshold.  So that
even low doses of radiation cause effects.  When I say they're
thought to have no threshold, I would say that that's the
position that regulatory agencies have taken.  There's not
scientific evidence one way or another.

      The severity does not vary with dose.  So if you get
cancer from having been exposed to radiation, the severity of
your cancer has nothing to do with dose.  You either get the
cancer or you don't get a cancer; severity does not vary with
dose.

      Typically, the stochastic effects are seen with low
doses and you can only induce them in a small percentage of the
population.  So you'll see when we talk about the carcinogenic
effects of radiation that it's only a small percentage of the
population that develop cancer.  There's no dose of radiation
that I can give that would make everyone develop cancer.

      Deterministic effects are listed on the slide.  The
lefthand slide has to do with somatic effects.  The righthand
slide has to do with fertility, and you can see that these are
pretty big doses.  Cataract formation, loss of hair, skin
reddening, those are all big doses, the kinds of things that we
might worry about with the Cincinnati experiments where they're
giving doses in 200 rems or so.

      But I guess the one thing I would point out on the
deterministic effects are the I131 therapy.  Notice the radiation
dose there because both Mr. and Mrs. Bush were treated with I131
therapy.  This is the radiation dose to the thyroid gland, and
I'll let you judge whether or not you think Mr. and Mrs. Bush are
still healthy.

      Okay, the risk that I'm going to talk mostly about is
the risk of lower doses of radiation.  As I mentioned, the risk
of mutagenic, tetragenic -- that is, the effect on a developing
embryo, a developing fetus -- and carcinogenic effects.  The
lefthand slide is from Washington University's Public Relations
magazine.  When they had an article in there about the effects of
low level radiation, they chose to illustrate the cover with a
nuclear weapon exploding.  It's one of the real problems whenever
you talk about radiation.

      What do we know about the mutagenic effects?  Well,
almost everything we know about the effects of radiation come
from the Hiroshima and Nagasaki survivors.  At Hiroshima and
Nagasaki there were 75,000 births to 38,000 parents who had been
exposed to radiation.  Among those 75,000 children, there was no
significant difference in the number of stillbirth, birth weight,
congenital abnormalities, infant mortalities, sex ratio,
childhood mortality, or leukemia.

      Because genetic effects often take several
generations to be expressed, because if you have a recessive
mutation, both parties have to have -- both parents have to have
had this recessive mutation, people will justifiably argue that
looking for these gross things is not a very good measurement of
whether or not mutagenesis occurred.  However, you can look in
the blood for abnormal chemicals which would be a result of
mutations.  As you can see, there was no evidence that any of
these abnormal chemicals were in the blood, and what BEIR V
concluded is that mutagenesis had not been demonstrated in
humans; that it's very clear that it happens in plants and
animals.  So when we worry about the effects of radiation, if we
protect ourselves from the carcinogenic effects of radiation,
that's sufficient to protect ourselves from its mutagenic
effects.

      The effects on the fetus depend on what the dose
actually was to the fetus and when ingestation exposure occurred. 
The slide on your left shows the percentage of children that were
born with severe retardation.  The lines indicate when in the
pregnancy -- the different colored lines are when in the
pregnancy the radiation exposure occurred, and the X-axis is the
radiation dose in gray.  Gray is 100 times a rad.  So that these
doses are really 50 and 100 rads and 150 rads.  So they're big
doses, much bigger -- they're sort of comparable to the kinds of
radiation therapy kinds of doses rather than diagnostic study
doses.

      What we can see is that the incidence of severe
retardation is greatest when a woman is exposed at 8 to 15 weeks
of her pregnancy.  And, interestingly, there actually was no
increase in severe retardation if it was less than 8 weeks or
greater than 25 weeks of pregnancy, and the risk is about four
times greater during that 8-to-15-week period compared to the 16-
to-25-week period.  Again, that's data from Hiroshima and
Nagasaki.

      You might say with severe retardation that's a pretty
major end point.  What about IQ?  Well, here's the data for IQ. 
The graph's a little bit different.  So let me explain it.

      Now the different colored lines represent the
radiation dose, and the X-axis is the gestational age.  One of
the things that you can notice is that even with very large
doses, greater than 100 rads or rems, there is no significant
difference in IQ at 0 to 7 weeks or greater than 26 weeks, and
that the same trend we saw for severe retardation we see with IQ. 
That is, at 8 to 15 weeks -- there's clearly an effect in the
very large radiation dose of 100 rems at both the 15 -- 8 to 15
and 16 to 25 weeks.  So very large doses of radiation clearly
affect CNS development.

      What BEIR V concludes is that mental retardation
effects on the CNS have the greatest effect, that the risk for
severe retardation is .4 percent per rem, that the decrease in IQ
is .3 IQ units per rem, and that there may be a threshold at 20
to 40 rems.  This was summarized in a handout that I gave that
was in the first agenda.

      Let's talk about radiation carcinogens.  Again from
the atomic bomb survivors, the carcinogenic effects of radiation
depends on the following factors.  It depends on the amount of
radiation, the type of radiation -- that is, alpha, beta,
gamma -- the portion of the body that was exposed -- some parts
of our body are more radiation-sensitive, others are less -- and
the dose rate.

      I think this is probably one of the best kept secrets
in radiation biology.  This tells you what has happened to
Hiroshima and Nagasaki survivors through about 1985.  The numbers
on the righthand slide include the dose in rems.  It includes the
number of people in that dose group.  The third column is the
expected number of cancers in that group, and the last column is
the excess cancers, and the excess cancers have been attributed
to the radiation exposure.

      If you go down to the very bottom, you can see that
among 76,000 people who have been exposed, there have been about
5,600 cancers, of which 340 have been attributed to their
radiation exposure.  So here we have a large population of
patients in which we exploded nuclear weapons in their midst, and
the excess number of cancers in that population have been 340 in
addition to the 5,600 that were expected.

      When we express the risk for developing cancer, we
use a concept called the man-rem or person-rem.  The concept is
that if this is a linear effect, that you get the same number of
cancers whether you expose 1,000 people to 1,000 rems or 100,000
people to 10 rems or 10 million people to 100 millirems.  All of
those combinations will cause the same number of cancers.

      According to BEIR V, the number of cancers you cause
when you get a million millirems is 80 excess cancer deaths. 
I'll point out on the lefthand side that that's not true with
some of those dose ranges.  We already mentioned that 1,000 rems
would probably be lethal.  So you certainly wouldn't get 800
cancers if you exposed 1,000 people to 1,000 rems, and what's
debated all the time is whether at the opposite end the 10
million people times 100 millirems, whether you really cause 800
cancers at that end.

      To put that risk into perspective, unfortunately, if
you have a million people and you exposed them to a rem of
radiation, they will get 220,800 cancer deaths.  The reason
they'll get so many is that 22 percent of us will die from
cancer.  So exposure of a million people to 1 rem of radiation
would change the number of cancer deaths from 220,000, which is
what we would normally have, to 220,800.  The reason that this
effect is so difficult to measure is because the cancer incidence
among different populations varies so greatly.  If you have one
population with 220,800 and another with 220,000, that's
perfectly within the variation that one would normally expect to
see.

      I mentioned that it depends on the part of the body
that is exposed, and what the lefthand slide shows you is that at
Hiroshima and Nagasaki 55 percent of all the leukemia that
occurred in that population was due to the radiation exposure. 
Eight percent of all cancers were due to the radiation exposure,
and then it goes down for the different organs, what percent has
been attributed to the radiation exposure.

      A few things I'd like to point out:  first of all,
everyone associates leukemia with radiation exposure, but you can
see that in terms of absolute numbers, the number of leukemias
that you get are very small in terms of absolute numbers.  You're
much more likely to get a solid cancer than a leukemia, but the
number of leukemias caused, divided by the number of leukemias
that would be expected, that ratio -- it's called the relative
risk -- is very high for leukemia, much higher than for other
cancers.

      The righthand slide is actually just to point out one
of the mysteries of life.  The orange cancers, there has been an
excess in the Hiroshima/Nagasaki population, and the white
cancers are cancers which have not been observed in excess.  Why
there are some cancers that occur in excess and others that don't
is not at all clear.

      Because different organs have different radiation
sensitivities and different propensities to develop cancer, there
are these things called weighting factors.  So when you have this
uneven distribution of radiation, you figure out what the total
risk is by multiplying the weighting factor times the radiation
dose to that organ and adding them all up, and that gives you a
risk factor which is an approximation of what kind of risk we
would have expected with a uniform whole body exposure, because
after all that's what we've had in the Hiroshima or Nagasaki
population, is this uniform whole body exposure.

      The righthand side shows that the risk for developing
cancer changes greatly with age.  You can see that if you're
below the age of 25 or 30, your risk of developing cancer from
radiation exposure is about three times what your risk is at
about age 35 or 40.  So age is a factor in terms of determining
the risk.

      The dose rate, we mentioned with radiation therapy
that they fractionate the dose; they give it over a prolonged
period of time, and that decreases the biological effect,
especially the unwanted effects when we're talking about
radiation therapy.

      The other thing that I wanted to point out is that
this long latent period between the time of exposure and the time
that these increases in cancers can be detected, that latent
period is typically 10 or 20 years.

      A few problems with the Hiroshima or Nagasaki data,
the weak links, so to speak:  it's not a random sample.  There
might have been other factors that caused an increased risk of
cancer.  For example, there was a fire storm after the bombing. 
Did people inhale and swallow carcinogens that were created in
that fire storm?  It's particularly interesting because the
stomach cancer is a very high component of the excess cancers in
Hiroshima and Nagasaki.

      Control group, how to pick that as a problem, whether
medical followup actually changed the number of deaths due to
cancer.  It certainly wasn't a planned scientific experiment. 
Extrapolating that information to low doses into other
populations are all problematic.

      So because of these problems, people have looked
other places to try to figure out what the effects of radiation
are.  As I mentioned, radiation varies from place to place from
natural sources, and this map of the United States shows you the
radiation dose in Denver is about three times what it is in
Florida.  If you look at cancer incidences relative to background
radiation, there's no relationship; that is, if you add up the
seven states with the highest background radiation and you look
at the cancer risk, and then compare them to the seven lowest,
there's no relationship between radiation dose and cancer risk. 
Those same sorts of studies have been repeated in other
countries, and I'll just leave it at that for now.

      So the bad news certainly is that radiation causes
cancer; there's no question about that.  The good news is that
radiation is a relatively weak carcinogen.  It's difficult to
cause cancer in patients due to exposure of radiation.

      Why don't I stop there and answer any questions that
you might have.

      CHAIRWOMAN FADEN:  Thank you very much, Henry.

      Can we turn the slide projectors off?  Thanks.

      DR. ROYAL:  I can't

      (Laughter.)

      CHAIRWOMAN FADEN:  You can't?  Can an able person
turn the slide projectors off?  That would be good, and we can
get the lights up.

      We have to have some time for questions.  We don't
have time, but we need to take some time for questions.

      So are there questions from the Committee?  Yes,
Lois?

      MS. NORRIS:  Could you define physical and biological
half-life and tell me why things are expressed in terms of half-
life?

      DR. ROYAL:  Okay.  What the physical half-life is is
it's a fundamental property of the radioactive atom itself.  It
defines pretty much the identity of that atom.  So half of the
radioactive atoms change to some other atom in that period of
time, and it's called the half-life.  So I131, for example, has
an eight-day half-life, and that's the physical half-life. 
Tegnesium 99M has a six-hour half-life.  Plutonium, if I remember
correctly, has a 14,000-year half-life.  Is that right, Duncan,
14,000?  I don't deal with plutonium every day in my medical
practice.  So remembering all these numbers isn't always easy. 
So that's a property of the radionuclide itself.

      The biological half-life depends on how the body
processes that radioactive material.  It's how long it stays
within the body.  So it gives you an idea of how long that
radioactive atom has the potential to expose the body before it's
excreted from the body.  That's not a property of the
radionuclide; it's really a property of the chemical form which
that radionuclide is incorporated in.

      So you can imagine that both of those factors, the
physical half-life and the biological half-life, are important in
terms of how much radiation dose I might get.  If it's rapidly
eliminated from the body, it makes no difference whether its
physical half-life is long.  On the other hand, if it stays in
the body for a long time but its physical half-life is short and
it decays very quickly, the fact that it stays in my body for a
long time doesn't make any difference.  The combination of those
two, by the way, is another term called the effective half-life.

      CHAIRWOMAN FADEN:  Other questions?  Yes, Ken?

      MR. FEINBERG:  When you put up the slide showing
group increases in cancer incidence rates, how do you go about
reconstructing dosage levels for those people?  In other words,
it's years later, say downwinders of the Hiroshima/Nagasaki
situation, but how do you go about -- what -- is it chromosomal
aberrations, thyroid scans?  How do you try and determine which
people received which dosage levels of radiation after the fact?

      DR. ROYAL:  There are no good ways of doing that.  I
say that even with Duncan in the audience.  Duncan has done a lot
of work with dose reconstruction studies.

      Hiroshima and Nagasaki was a relatively simple
problem in terms of estimating the dose.  The reason that was a
relatively simple problem is that most of the radiation came from
the bombs exploding themselves as opposed to from fallout.  In
order to calculate the radiation dose under those circumstances,
all you had to know is where that individual was in an instant in
time and you could probably calculate the radiation dose to plus
or minus 15 percent under those circumstances.

      When you start talking about the Hanford dose
reconstruction study, where suddenly you need to know what the
person was eating 20 or 30 years ago, where the actual amount of
material in the environment was not well known and was not
distributed in any simple fashion, the dose reconstruction
studies get to be -- there's a lot of uncertainty with dose
reconstruction studies.

      One thing that I would like to point out, though, I
sort of stopped before my outlined finished, but if at some point
we want to talk about this more, I'd be happy to finish up some
of the things.  But one of the things I want to point out now
that you've brought up Hanford is to look at that table that's in
the handout that says, "Environmental Releases of I131."  At the
time that Hanford released 685 kilo-Curies of I131 into the
environment, we released from 1945 to 1948 21,000 kilo-Curies of
I131 from atmospheric testing.  If you go up even further along
to how much I131 we released into the atmosphere from all nuclear
weapons testing, you'll see that it's a very, very large number.

      So I guess with figuring out environmental doses, we
have some idea of whether they're big doses or little doses, but
to say that we know precisely what the dose was to any individual
would be incorrect.

      CHAIRWOMAN FADEN:  Duncan, did you want to make a
comment?

      DR. THOMAS:  That was really an important question
and one that we really can't give justice to today.  I think that
might be an item we should contemplate for future -- one of our
educational sessions.

      CHAIRWOMAN FADEN:  Our continuing education sessions
will continue, and Henry's was a wonderful introduction, I
suspect, to those of us who are not knowledgeable in this area. 
It is only the beginning of the sorts of questions that we're
going to need to be educated about.

      DR. THOMAS:  Just a comment, I want to congratulate
Henry on what I think is really a very balanced account of what
is a highly polarized debate, but I can't let it go by without
comment the characterization of the Yalow paper as sort of middle
of the road.  It is middle of the road to some extent, but I also
feel like I see evidence as I read this paper of what I think in
your opening sentence quoted, professional bias, and I see that
reflected in various ways.  It's a topic I'd like to return to at
one of the future discussions.

      CHAIRWOMAN FADEN:  We surely will.  Thank you.

      You can tell already that we have a Committee made up
of independent-minded individuals with lots of expertise.

      Are there other questions?  Ruth?

      DR. MACKLIN:  This is just a very simple question. 
When you did your -- and I think I know the answer -- when you
did your little show and tell with the Geiger counter, you
pointed out an advantage or what you described as an advantage of
radiation hazards over biological hazards, since you could detect
them by means of the Geiger counter and would, therefore, know
that the hazard was present, et cetera.  I presume -- I mean,
isn't it fair to conclude that this is only something for
professionals, that applies to professionals, scientists,
physicians, and others working in that environment?  That is, the
reverse might in a sense be true of the ordinary person who
couldn't take any -- not only wouldn't know or be able to
detect -- most people don't have Geiger counters -- wouldn't be
able to know or detect that there was radiation or dangerous
levels present, but, moreover, if one were worried about
biological hazards, there are various kinds of things one can do
even in a general sense.  So when people go to countries where
hepatitis is high or something, they get gammaglobulin or some
people walk around wearing masks.  They do this in other
countries when there are germs.  I think to be balanced about
this, it's only the hazard for the professional worker where it's
detectable and not for the ordinary citizen; is that fair to
conclude?

      DR. ROYAL:  Well, I would not agree with you, no.  I
would say that if you believe that there are people in our
society who are interested in the public's health, that are
concerned about radiation, that it's much easier for them to buy
the equipment that's necessary to detect the radiation than it is
to buy the equipment that's necessary to detect hazardous waste
and biological hazards.  So I think even if you don't trust
professionals to protect society against radiation, that Geiger
counters are widely enough available that if there was some
secret collection of radiation somewhere, you would have heard
about it.

      CHAIRWOMAN FADEN:  In the interest of time, I think
we have to draw this to a close.  We thank Henry very much.

      We need to take a break because we need to take a
break.

      (Laughter.)

      Let me make one comment before we do that, and that
is to draw attention again to the period for public comment.  We
have four people who have signed up to comment.  We have an hour
set aside because it is for people -- from 3:15 to 4:15 -- the
expectation is that the people who have indicated a desire to
speak will speak for about five minutes and we will have about,
say, up to ten minutes of questions and answers from the
Committee.  If there is anyone here who would like to speak to
the Committee who did not give us advanced notice, would you
please let -- who do we have to let know?  Kris Crotty.

      Kris, can you wave your hand?

      Would you please let Kris know if you're in the
audience and have not already informed us that you would like an
opportunity to speak?

      We're going to take a very, very super-short break. 
What is it now?  It's 11:24.  Can we come back in less than 10
minutes, please?  I'm sorry, it's 11:20.  We need to start no
later than 11:26.

      (Off the record.)

      CHAIRWOMAN FADEN:  All right, we really need to
begin.  One of the problems with breaks is that they're hard to
break.  So we have to keep going.

      Susan Lederer is now going to give us an overview of
the history of human experimentation in the United States.

      DR. LEDERER:  I was very happy to hear Ruth say that
we would be revisiting this history.  I think that we will need
to do so over the course of our Committee deliberations, to do so
at several times and also from several different perspectives. 
What follows this morning is an introductory presentation in
which I will focus my remarks on the history of human
experimentation in the United States, and, in particular, to
direct attention to the conduct of human experimentation in the
first four decades of the 20th century.

      There are two reasons for adopting this focus at this
time.  The first is practical.  I don't have hours to detail
this, and we will be having another briefing on the history of
human experimentation at our next meeting.

      My second reason is more substantive.  I think it's
important for us to consider the conduct and experiments in the
decades preceding World War II because it was a milieu in which
many of the physicians whose experiments we will be considering
in the 1940s and 1950s were trained earlier; that is, in the
1940s and 1930s.

      As I hope to make clear this morning, I differ from
many of the other writers on the history of human experimentation
in arguing about the first great increase in human
experimentation dates not from World War II, but actually from
the late 19th and early 20th centuries, and that this increase in
human experimentation in those decades brought with it both
public and professional scrutiny of the moral problems posed by
human experimentation.

      Now this is not, of course, to say that human
experimentation began in the United States.  Of course it didn't. 
Experimentation on human beings can be traced to antiquity.  In
the 3rd century B.C. the Alexandrian anatomists, Herophilus and
Eristratus, reportedly practiced anatomical dissections on living
human beings, but as criminals sentenced to death for their
crimes against the state.  These literal vivisections, like most
of the human experiments conducted before the 19th century were
for the most part isolated events.  They weren't part of a
sustained or systemic research program.

      Like the Alexandria experiments, a number of human
experiments in the distant past were conducted in the name of the
state.  In early 18th century England, for example, before
subjecting the royal children to viralation, an early protection
against smallpox, inoculations of smallpox were conducted on
prisoners from Newgate Prison who were promised and who received
pardons for their participation in this innovative protection.

      Most experiments, however, were not sponsored by the
state, but reflected the individual interest of physicians who
frequently used members of their own families, their patients, or
themselves in tests of new drugs, in some cases vaccinations, and
medical procedures.

      In 1800, for example, when the first smallpox vaccine
reached this country, the physician, Benjamin Waterhouse,
performed initial vaccinations on his own son and six members of
his household.  In order to ensure the protective value of the
vaccine, he asked another physician to choose one of these
vaccinated group and inoculate him or her with live smallpox
material.  This doctor selected a 12-year-old servant boy and not
one of Waterhouse's own children for the experiment, and,
happily, the experiment was a success.

      The early trials of smallpox vaccine represented
attempts to improve the health of individual patients.  In
addition to such therapeutic or in some cases prophylactic
efforts, some physicians conducted nontherapeutic experiments
intended to advance information about human anatomy or
physiology.

      One of the most famous instances of nontherapeutic
human experimentation in the 19th century was the study of human
digestion conducted by Army physician William Beaumont in the
1820s and 1830s.  This story may be familiar to many of you, but
it's an important milestone.

      Beaumont was called in to treat a French-Canadian
trapper, Alexis St. Martin, who had received a gunshot wound to
the abdomen.  Unable to close the wound, Beaumont realized his
unprecedented opportunity to study the process of digestion in a
living human being.  In an unusual step, he actually contracted
with St. Martin for permission and cooperation in his
experimental program.  St. Martin agreed in exchange for board,
lodging, and $150 a year to assist and promote by all means in
his power "such philosophical and medical experiments as the said
William shall direct or cause to be made on or in the stomach" of
him.

      Now from all accounts, Beaumont and St. Martin had a
difficult relationship.  (Laughter.)  St. Martin, who found many
of the experiments uncomfortable -- these include, for example,
tying a piece of meat on a string and putting it into the fistula
and timing the digestive powers.  St. Martin was often absent for
projected periods of time, and Beaumont greatly resented the
apparent ingratitude of his often recalcitrant subject.  At no
point, however, were there public criticisms voiced about these
experiments and there was great interest in them.

      Before the Civil War, such contractual arrangements
between subjects and experimenters were unnecessary when white
physicians used slaves as research subjects.  In some instances
physicians advertised and purchased blacks for the sole purpose
of experiment.

      In one notable example, when physician James Marion
Simms became interested in a method to relieve vesico vaginal
fistula, a distressing condition that many women experienced as a
result of trauma in child birth, in which urine passed through
the vagina rather than the urethra, Simms developed an operation
on three slave women who underwent up to 30 experimental
procedures, and this in the years 1845 to 1849, without
anesthesia.

      Before performing the operation on white women, Simms
"ransacked the country" for additional negro cases and arranged
with individual slaveowners to keep the women in his hospital,
promising not to endanger their investment; that is, not to
endanger their lives.  The repair of vesico vaginal fistula was a
great benefit to women, both white and black, and it resulted
from a willingness in antebellum America to subject slave women
to the procedure until it was perfected.

      In the last quarter of the 19th century, changes in
medical theory and medical practice prompted a significant
increase in human experimentation.  The development of new
instruments, such as the gastric tube and the x-ray, prompted
considerable experimentation on both patients and healthy
subjects.

      One other medical change in medical theory in the
1860s and 1970s, the work of chemist Louis Pasteur and physician
Robert Koch introduced a new paradigm of medical science, that of
the germ theory of disease.  The use of human beings to confirm
that a particular germ or microbe caused a specific disease was
one of the harsh legacies of the germ theory.  Unable in many
cases to find a suitable animal model in which to study disease,
physicians turned to human beings as their research subjects. 
Before the discovery that monkeys, for example, could be infected
with syphilis and gonorrhea, the search for microbes of these
venereal infections prompted at least 40 published reports in the
biomedical literature in which individuals were inoculated with
the suspected germ in order to confirm the etiological status.

      Two American examples:  in 1982, a San Francisco
physician, George Fitch, described his efforts to infect young
girls in the leper colony at Molokai with what he identified as
the virus of syphilis.  Of course, it's not clear what he
actually meant.  He was unable to transmit syphilis to these
young girls.

      In 1895, New York physician Henry Hyman reported the
successful inoculation with gonorrhea of a 4-year-old boy
identified as an idiot with chronic epilepsy, a 16-year-old boy
also identified as an idiot, and a 26-year-old man in final
stages of tuberculosis.

      In Europe, two giants of the bacteriological era were
actually prosecuted for their experimental work on human
subjects.  Gerhardt Amhauer Hansen, who discovered the leprosy
bacillus, lost his medical license in 1880 for an experiment in
which he inoculated a bacterial culture into the eye of a unknown
female patient in an Oslo hospital.

      In 1900, Albert Neisser, who discovered the
gonococcus and helped develop the Wassermann test for syphilis,
was fined for his syphilitic serum experiments involving
prostitutes.

      The great increase in human experimentation did not
go unremarked by the public.  In the U.S. the moral issues posed
by experimenting on human subjects were most intently pursued by
the men and women committed to the protection of laboratory
animals.  Already pledged to saving dogs and cats from the
vivisector's knife, these American anti-vivisectionists warned
increasingly that the transformation of the family physician into
a researcher or into the scientist at the bedside would lead
directly to nontherapeutic experiments on human subjects.

      That animal protectionists would embark on a defense
of the human subjects of research may seem surprising today, but
in the early 20th century animal and human experimentation were
very closely linked, and, in fact, it was an anti-vivisectionist
sympathizer, the playwright George Bernard Shaw, who first
introduced the term "human guinea pig" in the early 20th century
to make clear the equation of human beings with laboratory
animals.

      Amid attempts to secure protective legislation for
the animal subjects of medical research, anti-vivisectionists and
their allies in the humane movement pressed for legislation to
protect the human subjects of biomedical research.  In the
briefing book I have enclosed a copy of Senate bill 3424
introduced by Senator Jacob Gallinger in March 1900 for the
regulation of scientific experiments upon human beings in the
District of Columbia.  As you see if you read the text of the
bill, the sponsors were particularly interested in protecting
what we would today consider vulnerable populations:  newborn
babies, children younger than 20 years, pregnant women, charity
hospital patients, and the mentally infirmed.

      If passed, the bill would have restricted scientific
experiments to duly qualified medical practitioners working for
the federal government or in the District of Columbia.  It also
required experimenters to apply for a license from the
Commissioners of the District.  Application would have included
both the objects and methods of the proposed experiments, as well
as the written and witnessed permission of the experimental
subjects.

      Finally, the legislation would have required a
written report six months after the experiment ended about the
results and the well-being of the subjects.  The bill, of course,
did not pass.

      But I think it would be a mistake to think that this
public discussion of human experimentation in the pages of
popular magazines and in the Senate chambers had no influence on
the way in which medical research was conducted.  For several
months after this legislation was introduced, Walter Reed and his
colleagues on the Yellow Fever Board took steps to insulate
themselves from public criticism when they adopted the unusual
step of written consent forms for the yellow fever experiments
being conducted in Havana in the fall and winter of 1900.

      Research on yellow fever, like syphilis and
gonorrhea, necessarily involved human beings.  Because there was
no animal model in which to study the disease at that time,
efforts to establish the transmission of this disease required
human subjects.  The deliberate infection of healthy human beings
with yellow fever involved significant risks for these research
participants, and, in fact, two members of the Yellow Fever Board
had suffered greatly through their bouts with the disease.  James
Carrol barely survived; his younger colleague, Jessie Lazear, did
not.

      Also in the briefing book I have included for you one
of the consent forms signed by one of the participants in the
yellow fever experiments in November of 1900.  This contract
outlined the risks of participation in this study as well as the
benefits, especially the good nursing care that the participants
would receive under government auspices.

      The American soldiers who took part in the
experiments received no immediate financial compensation for
their participation, although several of them 20 years later did
receive financial bonuses.  The Spanish volunteers, however,
received a large sum of money, $100 in American gold and an
additional $100 if they developed the disease, and the contract
also stipulated that if the patient did not survive the
experiment, the money would go to the family.

      With the approval of the Spanish Council, Walter Reed
restricted participation to those over the age of 24, which was
then the Spanish age of consent.  Now these written contracts, as
other people have pointed out, probably wouldn't pass scrutiny of
our current IRBs.  They exaggerate the inevitability of the
natural infection with yellow fever and they underplay to some
extent the danger to life that a yellow fever experience posed,
but they also mark a significant departure in the history of
human experimentation.

      I believe it was no accident that Reed adopted such
extraordinary measures on the heels of another much criticized
experiment in yellow fever research.  In 1897, just three years
earlier, the Italian bacteriologist, Sanarelli, had announced
that he had discovered the bacillus that causes yellow fever.  In
order to demonstrate that his germ was, in fact, the causative
microbe, he claimed to have produced yellow fever in five
patients by injecting them with the specimen.

      No less than the distinguished clinician William
Osler harshly criticized these experiments both in his textbook
and in testimony before the Senate.  When one American researcher
dismissed Sanarelli's claims as ridiculous, Osler countered to
deliberately infect a poison of known high degree of virulency
into a human being, unless you obtain that man's sanction, is not
ridiculous; it is criminal.

      Now let me just say that Reed's use of written
consent forms to ensure that his research subjects were informed
of the risks and benefits they incurred through their
participation helped avert public criticism.  There was some, but
it tended to be minor.

      But so did the successful outcome of the yellow fever
project.  Reed and his colleagues were able to convincingly
demonstrate the mosquito vector of yellow fever, which in turn
made possible control of the disease in Cuba and later in the
Canal Zone.  Successful outcomes did much to avert public
criticism, both public criticism and professional criticism, of
human experimentation in the first half of the 20th century, and
it might also be true today.

      Now Reed's use of these written consent forms,
particularly for these nontherapeutic experiments was followed by
other American physicians experimenting on populations in the
American-occupied Philippines.  In 1912 and 1913, American
investigators from the biological laboratory of the Philippine
Bureau of Science obtained written consent from the inmates of
Manilla's Bilibid Prison for their participation in research.

      Unlike the Spanish immigrants in the yellow fever
studies, they received no financial inducements, participating
without possible immunity to prison discipline or commutation of
sentence.  Why these prisoners agreed to take part in this
research remains obscure.  It's not easily recoverable by
historical methods.  They may have welcomed the diversion.  They
may have believed it would help medical science.  They may have
believed it would help their individual case or they may have
been misled.

      Nonetheless, before feeding in one case gelatin
capsules containing pathogenic amoebic organisms to prison
inmates, American physicians Ernest Walker and Andrew Sellards
informed subjects in their own native dialect about the
experiment and the possibility of dysentery and obtained written
permission from them.

      Similarly, investigators Richard Strong and B.C.
Crowell, who also used these prisoners in experiments to
determine whether beriberi was an infectious disease or the
result of dietetic factors, obtained written consent, but in this
case also offered prisoners both cigarettes and cigars as an
incentive to remain on a rice diet.

      That the consent of the research subject was
necessary for ethical experimentation was widely shared among
American researchers.  In the final document, I include for you
in the briefing book you find an editorial appearing in the
November 1916 Journal of the American Medical Association, written by
Harvard physiologist Walter Bradford Cannon, in response in this
case to criticism in the public press about controversial
experiments involving syphilitic patients in a Michigan hospital. 
Cannon here makes a strong case for the right and wrong of making
experiments on human beings, and this is a quote:

      "There is no more primitive and fundamental right
which any individual possesses than that of controlling the uses
to which his own body is put.  Mankind has struggled for
centuries for the recognition of this right.  Civilized society
is based on the recognition of it.  The lay public is perfectly
clear about it.  Any hospital official or physician known to
commit or to allow violation of the sacredness of the person
becomes at once the object of hostility.  Society as now
constituted will, obviously, not countenance any operation
performed for the satisfaction of the operator or for the
assurance of the investigator, whether or not for the immediate
benefit of others, unless the consent of the person on whom the
operation is to be performed has previously been obtained."

      Now given this strong support from a leading American
medical researcher about the necessity of the consent of the
patient, it is surprising, then, that in 1916 the American
Medical Association rejected a proposal for many of these
investigators to amend the Code of Ethics to include an explicit
provision stating that ethical human experimentation required the
expressed written consent of the subject or the parent or
guardian.

      Physicians and researchers agree in principle on the
necessary conditions for ethical human experimentation.  In
addition to consent, researchers had responsibility for the well-
being of patients.  Reckless sacrifice could not be countenanced.

      At the same time, many physicians believe that
introducing such an explicit requirement for consent would
complicate either the researcher-subject  relationship or the
doctor-patient encounter, and, thus, interfere not only with the
practice of medicine, but with the progress of medical science.

      Would expressed consent be needed for a minor blood
test or a simply urine test or a blood pressure reading, some
physicians wondered.  Would this requirement needlessly confound
the progress of research?  Amid the concerns of leading hospital
administrators and researchers, the proposal was dropped.  The
AMA Code of Ethics was not amended to address human
experimentation until 1946.

      In the 1920s and 1930s some American physicians
continued to concern themselves about unethical human
experimentation.  They particularly sought to insulate medical
research from becoming the object of public hostility and in some
cases anti-vivisectionist attack.

      One of the ironies, I think, of the American history
of medical experimentation is the fact that animal subjects have
apparently been the objects of greater concern than human
subjects.  In the years before World War II, American
investigators or, more accurately, an influential segment of the
medical research community monitored potential abuses of human
subjects not only for the protection of the human individuals
involved, but because it could create problems with animal
protectionists.  And I'll just give you one example.

      In 1941, Peyton Rous, editor of the influential
Journal of Experimental Medicine, chastised a San Diego physician who
had submitted a manuscript to the Journal describing the
inoculation of a 1-year-old volunteer with herpes virus. 
Returning the manuscript, which was not accepted for publication,
Rous informed the physician, "I cannot let this occasion pass
without saying that in my personal view the inoculation of a 12-
month-old infant with herpes obtained from an adult was an abuse
of power, an infringement on the rights of the individual, and
not excusable because the illness which followed had implications
for science.

      "The statement that the child was offered as a
volunteer, whatever that may mean, does not palliate the action. 
I believe you will find this to be the view of most physicians
who learn of the experiment and of all scientists who are aware
of the pathogenic powers of the herpes virus."

      In this case, however, Rous was not a good predictor
of what other physicians would do.  The article subsequently
appeared in the Journal of Pediatrics in 1942, together with the
description of a virus administered to a volunteer, a 12-month-
old white girl named Estee.

      I think that -- I hope that it's clear from this very
brief introduction to the history, the American history of human
experimentation before the end of the Second World War, that the
moral problem posed by using human beings in medical research had
been the subject of both professional and public discussion.

      American physicians agreed in principle about the
necessary conditions for ethical experimentation.  I didn't
develop it here, but self-experimentation could mitigate
concerns, prior animal testing to at least ensure some protection
for the human subject, as well as the consent of the subject. 
But there existed at this time no formal rules for research or
mechanisms to ensure compliance with these agreed-upon
principles.

      And, again, I can't but note that there is an ironic
comparison with the conduct of animal experiments because as
early as 1908 American investigators had voluntarily adopted a
set of rules for research involving animals, but no such rules
were posted in hospitals, where clinical investigation involving
human subjects was ongoing.

      A fear of public reprisal had encouraged some
researchers to encourage greater care in the conduct of human
experimentation, but many researchers remained unconcerned about
public reactions to their work.  In 1941, when Rous had accused
the author of that manuscript of abusing his 12-month-old
volunteer, a study that would come to dominate the history of
human experimentation in the 20th century was already nine years
old.  I refer, of course, to the Tuskegee syphilis study which
I'm sure is very well known to many members of this committee.

      I think it's worth recalling, however, that the
public outrage at a government-sponsored study of untreated
syphilis in black men more than any other single experiment, as
historian James Jones has argued, produced in 1974 the
legislative protections that govern human experimentation today.

      Although I run the risk of repeating what is well
known perhaps for this audience, let me just say that the
Tuskegee syphilis study began in 1932 as an attempt to follow the
course of untreated syphilis in black men in rural Alabama.  In
order to recruit and maintain the eventual 400 subjects and 200-
some controls, investigators from the Public Health Service
offered a variety of incentives to men in the study, including a
$50 burial stipend if the family would allow an autopsy.

      At the same time, government doctors misled the men
by offering such painful diagnostic procedures as lumbar puncture
as special treatments for their bad blood.  Government doctors,
who initially assumed the men would not seek treatment for their
disease, also took steps to ensure that the men would not receive
treatment.  During the Second World War, for example, a number of
men in the study were called for military service, diagnosed with
syphilis, and ordered to get treatment for their disease. 
Intervention by study doctors led the local draft board to
exclude the men from this available free treatment.

      In 1943, when the Public Health Service began
administering penicillin to syphilitic patients at treatment
centers around the nation, men in the Tuskegee study were
explicitly excluded from treatment.  Penicillin, rather than
ending the study, made the long-term, no-treatment experiment a
never-to-be-repeated opportunity.

      The study ended in 1972 amid a great national
discussion about the use of human beings or the appropriate use
of human beings in medical research, a discussion which also
included reviews or discussion of the Cincinnati experiment,
which is on our agenda for this afternoon.

      I think I'm going to end here.

      CHAIRWOMAN FADEN:  Thank you very much, Susan.  Don't
go any place.

      DR. LEDERER:  Okay.

      CHAIRWOMAN FADEN:  Thank you so much.

      We have time for a few comments or questions from
Committee members.  Ruth?

      DR. MACKLIN:  I have a couple of brief questions.

      You described the bill that we have here, which I
found very interesting to read, that was introduced into the
Senate.  You then, I think, said that you -- I think you used the
word "obvious."  You stated that "obviously" it didn't pass.  I
wonder if you can say more about that.  In other words, did you
read or is there an account of what the debate was like in
Congress and what the considerations were that led to its not
passing?  That's the first question.  I have a second brief one.

      DR. LEDERER:  Okay.  I meant "obviously," because
otherwise you would know about it.  I mean, did you know about
this bill previous to this discussion?

      DR. MACKLIN:  No.

      DR. LEDERER:  I mean, obviously, otherwise it would
have been known -- 

      DR. MACKLIN:  But not obvious, that it was so obvious
why it wouldn't have passed?

      DR. LEDERER:  That's right.  It was introduced by a
very powerful Senator, Jacob Gaellinger, to the Committee of the
District of Columbia.  It did not get out of committee. 
Gaellinger was extensively lobbied by leading American
physicians, who argued that it would create sort of a malpractice
frenzy in this country, and that was one of the medical arguments
against the bill.

      It also -- it's not clear to me whether he was
putting it forward as an example for education rather than an
attempt to actually proscribe the activities of medical
researchers.

      Does that answer -- 

      DR. MACKLIN:  Partly.  I mean, the question is:  what
was on the other side?  I mean, in other words, the explanation
that there were lobbyists and that lobbying was there describes
the political process.  When the Senators debated -- presumably,
they debated -- 

      DR. LEDERER:  Well, it did not get out of committee,
though.  That's my understanding.

      DR. MACKLIN:  I understand.

      DR. LEDERER:  So I'm not sure how extensive of a
debate it was.

      DR. MACKLIN:  Okay.  My other question, which is also
brief and direct, is you several times mentioned that there was
public concern about animals in research than human subjects. 
Here, again, more of an explanation is needed.

      First of all, is it possible that the use of animals
in research was more visible to the public than the use of human
subjects?  That is, known to you as an historian is one thing,
but what is visible to the public at any given time -- I mean,
could that be part of the reason?

      And, secondly, could you, in surmising why the public
was more interested in animals than in human subjects of
research, link it to any other phenomena about which there were
maybe laws or concerns.  For example, I may have this wrong, but
I seem to recall that there were laws for the prevention of
cruelty to animals before there were laws that protected children
either from abuse, which the reporting requirements are very
recent, or even before that, the child labor laws.  So this
seemed to be a broader phenomenon, social phenomenon, than simply
one that was located in human subjects research.

      DR. LEDERER:  Right.  I guess at this point I
wasn't -- I don't have a good explanation for whether Americans
were more inclined to support animal -- I mean, more inclined to
try to protect animal subjects of research than human subjects. 
I'm saying that apparently seemed to be the case.  Certainly, the
agitation you have of animals is much greater than that for human
subjects.

      The point that I would make about the child
protection is that it turns that the people who are agitating for
child protection were also the people who were trying to protect
animals, that in both cases the same group of individuals
fighting for both protection for cruelty from abuse and neglect
from parents or guardians, and also trying to enlarge their scope
to include the human subjects of biomedical research.  I mean, in
both cases we're talking about the same group of people.

      CHAIRWOMAN FADEN:  Fascinating.

      Jay?

      DR. KATZ:  Yes, just a brief comment.  it was a
beautiful presentation of early human experimentation, but I want
to underscore there is this, even still this puzzle which I think
is also evident in contemporary research; namely, here are these
voices of the past, Osler, Reed, and others, who were very much
aware of the ethical implications of doing research with
unconsenting subjects.  Yet, by and large -- and this is
something that still needs to be researched by you
historians -- it seems that the majority of researchers, but the
public as well, didn't pay much attention to it except
occasionally when there were outbursts in newspapers.

      You mentioned the 1942 published research with this
1-year-old baby.  At the turn of the century, a Scandinavian
investigator, and it's one of many -- there are some historical
documents available on pre-World War II research.  He did
research with young children, and in the article that he
published -- it was published in the then-leading German medical
journal -- he said:  I could have used sheep instead, but they
are too expensive and too difficult to keep.

      What struck me about this thing, he might have
thought it and done it for that reason, but why didn't he cross
it out from his manuscripts?  He didn't have to say this, and
this was read by many fellow scientists and nobody objected.

      DR. LEDERER:  Well, it actually did come up in some
of the Senate hearings about whether or not animal subjects
should be protected.  Of course, you put your finger on an
absolute puzzle:  why, given the kinds of concerns raised not
just by stray physicians, but by leading physicians -- I mean,
Osler was one of the most influential physicians in 20th century
America.

      CHAIRWOMAN FADEN:  Ever.

      DR. LEDERER:  Okay, ever.  Why was his voice
unheeded?

      CHAIRWOMAN FADEN:  I think we can't take questions. 
I'm sorry.

      Thank you so much.  It was a wonderful presentation. 
Again, we will be -- if you can corral people afterwards, that's
fine, but we really have to constrain the dynamic to keep things
going.

      We may all be very hungry, but we can't eat yet.  We
have one more presentation that we have to get in or we will
never get our agenda anywhere near in.  So we've got Jeff Kahn
and Jeremy Sugarman.  We're going to now switch from our first
objective, which was the self-education objective that I made
reference to.  Hopefully, we've absorbed a lot and learned some,
and we'll learn more.  We're now moving to reports from the staff
of how far they've gone with some of the four specific tasks that
we as a committee left them with at the end of the first meeting.

      So, to remind everyone, as I mentioned earlier this
morning, we did ask staff to identify what the historical
policies and standards were for research involving human subjects
for all of the agencies that fall under our purview.  We are
interested in articulating this from, roughly, the 1940s through
to the present, and Jeff will give us a brief presentation as to
how far we've gone.

      DR. KAHN:  Thank you.

      Let me say at the outset, too, that in addition to
Jeremy and I, our colleague, Jonathan Moreno, worked on this
document, and he's unavailable today, but he'll be with us in
future months.

      As Chairwoman Faden pointed out, the Advisory
Committee requested at the last meeting that we do research into
the history of human research policies at the various agencies
that we are charged with being in contact with.  To that end,
inquiries have been made to the Departments of Energy, Health and
Human Services, Defense, and Veterans Affairs, as well as to the
CIA and NASA.  We've also recently identified FEMA as a
potentially relevant agency in that its predecessor agency was
the Office of War Preparedness.  They will be asked to provide
documents in the near future.

      Before updating the Committee on the status of our
own research on policies regarding human research, I'd like to
note that in 1991 -- this is background -- 16 federal agencies
and departments, including those of the Interagency Working
Group, adopted the federal policy for the protection of human
subjects.  This federal policy has come to be known as the common
rule and is based on policies regarding research on adults
adopted by then-Department of Health, Education, and Welfare in
1974.  This is what Professor Macklin was referring to as 45 CFR
46.  In particular, it's subpart A of that part of the Code of
Federal Regulations.  Prior to the adoption of the common rule in
1991, policies regarding human subjects research were set agency
by agency.  That's just as background.

      To update you on our efforts now agency by agency,
first, Health and Human Services:  in response to our request, we
have received a chronology of human subject research policies. 
We are working through that presently, along with looking at the
excellent secondary sources that exist, among them Faden and
Beauchamp's "A History in Theory of Informed Consent" and Katz,
et al, "Experimentation with Human Beings."  I will continue to
use those to describe the policies at this agency, like I did
just a second ago with the 1974 Code of Federal Regulations.

      The Department of Energy:  to date, the Department
has provided an overview report outlining human subject research
at DOE.  Early documents that we have now come across show that
as early as 1947 DOE policies on human experimentation existed. 
A letter from Atomic Energy Commission General Manager Carroll
Wilson to UCLA researcher, Dr. Stafford Warren, dated April 30 of
1947, enunciated a policy that did not require that AEC
contractors obtain signed consent forms, but did require that
written certification of informed consent be provided by two
doctors as part of an official record.  Additional light might be
shed on the genesis and dissemination of this sort of policy
through continued search of archival sources.

      The Department of Defense:  we have begun to receive
documents in response to our request to the Department of
Defense.  Specifically, in response to Professor Katz' alerting
the staff to the existence of a classified version of the
Nuremberg Code at our last Committee meeting, we requested that
DOD research the existence of such a document, along with
whatever contextual documents surrounded it.  DOD has provided
what is marked as a classified memorandum from Charles Wilson,
then-Secretary of Defense, to the Secretaries of the Army, Navy,
Air Force, dated February 26, 1953.  It is entitled, "Use of
Human Volunteers in Experimental Research."  As Professor Katz
noted, it is a verbatim repetition of the Nuremberg Code, and it
is that without apparent attribution.

      The staff has since obtained a second memo, dated
March 3rd of 1953, disseminating the classified Nuremberg Code to
the Joint Chiefs of Staff.  Recently, in the last few days,
further evidence of the dissemination of a declassified version
of this memo in the Army has come up, and it's mentioned in a
1975 Army Inspector General's report on the Chemical Corps' LSD
studies.  So there seems to be some evidence of dissemination
through at least one branch of the service, of a declassified
version of that 1953 memo, and a declassification appears to have
happened in 1954, at least in the Army.

      In terms of the Department of Veterans' Affairs, as
of our last conversation with them, they were finalizing a
document outlining research policies and procedures.  We have yet
to review these materials, but we will in the near future.

      The Central Intelligence Agency:  materials related
to human research policies dating to 1977 were received just day
before yesterday and we'll review those in the next few days and
weeks.

      NASA:  materials are being assembled and will be
delivered to the Committee offices in the next day or two, we're
assured.

      An additional point, evidence of the interagency
nature of some policies regarding human subject research has now
been found; specifically, in the form of correspondence from
something called the Committee on Medical Research, or CMR. 
During the Second World War the CMR distributed some $25 million
to universities, hospitals, and other institutions to benefit
soldiers affected by various diseases in the field.  The
contracts and organizational structure of the CMR were inherited
by the NIH.  So there's some connection between the military and
the NIH in this Committee.

      In 1942, correspondence between someone called J. E.
Moore and someone else called A. N. Richards, the CMR answered a
query from a researcher at the University of Rochester regarding
CMR policy toward human experimentation, the response being that
there were requirements for informed volunteers and signed
consent forms.  So there's some history in terms of interagency
collaboration, in terms of policy as early as 1942.

      So, to conclude, our research to date has uncovered
what we think is important information and indicates both that
human subject research policies existed prior to the time usually
taken as the starting point for test policies, that future agency
policies may well have existed, and that many questions exist
about the dissemination and implementation of such policies.  The
staff will continue to research these and other questions at the
Committee's direction.

      CHAIRWOMAN FADEN:  Thank you very much, Jeff.

      We're going to take questions now from Committee
members to Jeff and Jeremy.

      DR. KATZ:  Jeff, do you have a copy of the informed
consent chapter?  I think it's here.

      DR. KAHN:  Faden and Beauchamp?  Not in front of me.

      DR. KAHN:  No, no, of the -- it's not here -- 

      CHAIRWOMAN FADEN:  The IG report?

      DR. KAHN:  It would have been nice for you to have
read the last paragraph, the conclusions of that Inspector
General's -- 

      CHAIRWOMAN FADEN:  It's in -- excuse me, Jay.  It's
in everybody's handout packet.  You mean the chapter from the IG
report on informed consent?

      DR. KAHN:  The idea -- 

      CHAIRWOMAN FADEN:  Yes.

      DR. KAHN:  Oh, it is in today's -- 

      CHAIRWOMAN FADEN:  In today's.

      DR. KAHN:  Yes, I have it right here.  Let me just
read it because it goes to the kind of tensions that that Ruth
Macklin was talking about, that Susan Lederer was talking about.

      "In summary, the evidence clearly reflected that
every possible medical consideration was observed by the
professional investigators at the medical research laboratories. 
Volunteers were not fully informed as required prior to their
participation, and the methods of reviewing their services in
many cases appeared not to have been in accord with the intent of
the Department of the Army policies governing the use of
volunteers in research."

      This is a sad conclusion that they came to, period.

      CHAIRWOMAN FADEN:  Ruth?

      DR. MACKLIN:  Yes, one thing, this is just a very
brief observation, and I noted it in some of these documents in
here, which goes to the question of the dual purpose that the
consent was alleged to have been -- for which it was sought, in
addition to informing the subject and all those wonderful words
we heard about before, in accordance with ethical principles, on
the October 9, 1942 response -- and it was somewhere else as
well.  There were two items here.

      "When any risks are involved, volunteers should only
be used as subjects and these only after the risks have been
fully explained and" -- and it's this key -- "and signed
statements of intent which prove that the volunteer offered his
services with full knowledge and" -- and it's this next
clause -- "and that claims for damages will be waived."

      Now I mention that if only to say that the motives
may not have been entirely pure from an ethical standpoint, and
there are these two purposes for which one might have sought
that.  I don't know anything about the history of malpractice or
claims or suits being brought against it, but at least that
alerts us to that, and maybe you have something to say about
that.

      The other point is you mentioned -- and I think Jay's
question also or point goes to this, and that is, one issue was
what the written standards were; what policies there were; who
knew about them; who had articulated them, et cetera, in the
agencies.  A second question has to do with the implementation of
those, and that was already mentioned, and whether there was any
review or mechanism for review of the implementation.  And the
third -- I guess this is like part of the implementation -- is
the researchers themselves who did research under those standards
or guidelines, were they given a piece of paper; did policies go
to them?  I mean one could always claim ignorance.  You could
say, well, sure, those standards were there and the departments
had them, but as far as the researchers themselves might claim
total ignorance of the standards or rules governing them.

      DR. KAHN:  We have also wrestled with those questions
at the staff level, and we're hoping that we can get some
direction from the Committee about how to approach some of those
kinds of issues.

      Let me say, before Dan jumps in here, regarding your
first point, that there was a hope that liability could be
shifted, it appears in some of the correspondence.  We are
cognizant of that and we're looking into the history to see if we
can tease out how the policies got written as they did.  Of
course, this is all spade work, and all we can say at the moment
is this is what the correspondence has to say, and the background
will come, hopefully, to light as we move forward.

      MR. GUTTMAN:  I'd just like to make a procedural
comment.  I'm not going to touch on the ethical or scientific or
whatever.

      But, as we all recall, at the last  meeting Dr. Katz
mentioned the classified Nuremberg Code, and when we got -- we
sent a letter, which you have a copy of, a broad request of the
kind Ken Feinberg is most familiar with, saying we want all
documents related to ethical codes, not just the code.  What we
got from the Defense Department was this 1953 document, and it
immediately occurred, even to myself, that maybe there were
things before it and things after it.

      We got from Gil Whittemore, who got from a group at
Boston, this other document that shows the dissemination.  We
called the Defense Department, Jon Moreno and I, last Friday and
said, "People are going to be curious.  What do you know?"  And
the answer was we know zero about what comes before and after it.

      I want to tell you this because it's important to
appreciate how much of an exploration we're on.  Last Friday Ruth
and I were sitting around the office, and Ruth said, "Well, just
because the Secretary of Defense signs something, it doesn't mean
anybody implements it."

      We got in the mail from Jay Katz a document, 150
pages -- you all have an excerpt; the people in the audience
don't have it because we just put it out yesterday, a copy.  It
claims that this 1953 memo was not an aberration.  It says,
paraphrasing, this was the result of extensive internal
deliberations on the Nuremberg Code in the Defense Department. 
It was not simply disseminated through the normal channels, but
this part of the history is for the Army Chemical Corps, who was
a contemporaneous advisory committee on the Chemical Corps,
including civilian doctors and laboratory directors who discussed
it, and the report makes note that this was unusual because it
wasn't just a chain of command, and that is -- we were saying
earlier it was implemented at least in the Army.

      The point is we are onto a real puzzle here, and I
don't mean to step on the substance of this, but just to say that
procedurally the Committee is in the middle of something that
obviously is of importance.  Where it goes, Dr. Katz and you all
can, you know, puzzle out better than I can.

      The Defense Department, of course, is
theoretically -- is going to get back and give us the before and
afterwards.  They can reconstruct it, I would presume.

      CHAIRWOMAN FADEN:  Are there other questions for Jeff
and Jeremy about this part of the task?  Related comments would
include keep going.  I assume that we want the staff to continue
to pursue?  Yes, everybody is eager to hear the end of the story
as much as we can get it, and Dan's deeper background helps us
understand it's not going to be easy, but remember this is a task
that starts in the forties, and perhaps Susan would suggest
earlier, and it's intended to go up to the present.  So it's
going to take us a while to get here, and it's focusing right now
on policies and guidelines.

      The question of how we attack simultaneously issues
of what the practices were is something, hopefully, we'll talk
about tomorrow afternoon, what the right strategy should be for
that.

      Yes, Henry?

      DR. ROYAL:  What are we doing to find out what the
ethical standards were with medical organizations?  My concern is
that most physicians are not government employees and unlikely to
be very interested in or read government policies.

      CHAIRWOMAN FADEN:  I don't know if, Jeff or Jeremy,
you want to respond to that real briefly.

      DR. SUGARMAN:  We haven't -- during this
investigation we've focused, as we had said, on official policies
and documentation as a way of getting an idea of how big the
field looks, at least for official statements.

      John Harkness, who is a consultant to the Committee,
has done some work about the AMA, for instance, and how
professional codes become adumbrated or announced in formal ways. 
If the Committee desires us to look into those sorts of things,
then we can certainly pursue that avenue.

      CHAIRWOMAN FADEN:  Part of the thinking is -- I mean,
I think Henry's quite right, and this is the sort of stuff we'll
continue to talk about tomorrow -- we need to know what the
pronouncements and rhetoric on the nonofficial, nonfederal side
were as well, but part of the thinking is that because so much,
obviously, research involving the subjects is funded at some
point or other by the federal government, that the reach of the
policies of the federal government go beyond people in the direct
employ of the government to grantees and contractors as well, but
I think your point's very well taken.

      So we'll take it that, staff, we've now expanded -- 

      DR. KATZ:  It must be done, you know, but it wouldn't
take much time.  So that's one nice thing about it.  There's very
little that we will, I think, come up with.  Maybe we will
discuss something with some of us -- 

      DR. SUGARMAN:  I wouldn't hazard a guess about how
much time it will take, but I would say also that we've had some
staff discussions about the possibility of other funding sources,
such as foundations, realizing that places like Rockefeller, et
cetera, have funded certain kinds of research and are seeking
some sort of guidance, because there are other funding mechanisms
and when funding mechanisms change, how that might change the
sort of principles, and behaviors of individuals engaged in
research involving human subjects might change depending on such
things.

      CHAIRWOMAN FADEN:  Are there other questions or
comments?

      (No response.)

      Thank you very much, Jeff and Jeremy.

      What they present makes it sound like it took them a
half a day to do this, but it really has been many people-hours
of work to get us even to this point.

      I hesitate to say this, but I think we're back on
schedule.  Is that possible?  Is it 12:30 and we're supposed to
break for lunch at 12:30?  So we are breaking for lunch at 12:30.

      A note to Committee members and staff:  there is
reserved seating in the hotel restaurant on this floor, which is
a departure from what we did at last meeting.  For Committee
members and staff, there's a fixed-price buffet, which should
make getting lunch simpler than it was at our last meeting.

      We are going to resume promptly at 1:45.

      (Whereupon, at 12:27 p.m., the proceedings recessed
for lunch to reconvene at 1:45 p.m. the same day.)

                     A-F-T-E-R-N-O-O-N   S-E-S-S-I-O-N

                                                                  1:47 p.m.

      CHAIRWOMAN FADEN:  Henry said that there was a
possibility that he wouldn't be able to join us for the first
part of the afternoon.  So his is an explained absence.

      We need to proceed.  We're now going to move forward
with the reports from the staff with respect to a second charge
that we had given to the staff, which was to take three classes
of experiments and create basically methodological case studies
for us, and the first one we're going to hear about is the
Cincinnati experiments situation and the work that the staff has
done there.  Ron's going to give us a brief presentation.

      DR. NEUMANN:  The Committee chose at its last meeting
three case studies in order to better examine the methodologies
of review which may be applicable to scientific or medical
experimentation and to evaluate which of these methodologies may
be most useful for the Committee's future work.

      The series of experiments termed the Cincinnati
experiments for purposes of our discussion today include those
experiments which were contracted for between 1960 and 1972 by
the Defense Atomic Support Agency, or DASA, and carried out by
Dr. Eugene L. Saenger and his colleagues, primarily at the
Cincinnati General Hospital.

      The stated goals of this contracted work were, No. 1,
to study the metabolic changes in humans following total body
irradiation in an effort to find a central biochemical test which
might serve as biologic dosimeter; that is, a measure of the
amount of radiation received by an individual.

      The second purpose was to evaluate the psychological
status and performance capabilities of individuals exposed to
varying levels of total body irradiation.  Dr. Saenger has stated
in numerous documents that the DASA-funded work was, in fact,
piggybacked, if you will, on his clinical human experimental
program to evaluate total body irradiation as a palliated measure
for patients with advanced or metastatic cancers of various
types.

      The Committee to date has received approximately 4
linear feet of boxes containing several types of documents from
multiple federal agencies and also from patient families.  The
documents are listed for you in the staff memo which begins the
section in your notebooks marked by the Tab L.  Because of real
limitations on the amounts of material which could be
photocopied, sent to you, and read by you, only the starred items
are included for your review.  However, all other documents are
obviously available for you, should you so desire.

      This case, the Cincinnati experiments, I believe
typifies the strengths of a fact-finding process which at least
to date has focused on document review.  However, several of the
documents made available to you were previously generated by
committees who were empowered to review Dr. Saenger's
experimental program or chose to do so of their own accord for
various reasons.

      Our staff review of the available documents suggests
that an even more complete understanding of this story may be
generated as several additional records were located and could be
made available to the Committee.  These are detailed, and I'll
just go over them briefly with you.

      The additional documents which we feel should be
searched for and may provide informative information include, No.
1, any documents on the original Saenger protocol for determining
the palliative or anti-tumor effects of total body irradiation. 
There is no separately stated protocol in Dr. Saenger's 1958 to
'59 contract proposal other than that for which he requested
funds from DASA, and we believe it would be of interest to both
the Committee and other parties involved if this type of protocol
documentation could be provided for review.

      No. 2, correspondence on psychological testing.  The
initial protocol did not include a large degree of interest in
psychological or performance testing of the patients, but
sometime between '63 and '64 the psychological and cognitive
testing component of the experiments were considerably expanded. 
We to date have not been able to find documentations that would
explain the reason for this enhanced psychological testing
program, the origins of the need to expand the research that was
ongoing, and the mechanisms requested for its support.

      No. 3 would be original report submitted to the
American College of Radiology.  You'll note in your information
materials that the letter by the American College of Radiology
President McConnell at the time to Senator Gravel is obviously
what the historians call a secondary source.  It was based upon
interviews conducted independently by a committee made up of Drs.
Henry Kaplan, Frank Hendrickson, and Samuel Taylor with the
assistance of a staff member of the ACR staff named Mr. Linton. 
We believe it would be useful to see the original internal
reports submitted by this committee to President McConnell's ACR
office which were used by President McConnell in drafting his
letter.

      No. 4, Dr. Saenger's bibliography, a more thorough
review of Dr. Saenger's publications is thought to probably be
useful.  A simple review of his CV, including his bibliography,
indicates the number of scientific publications resulted from
this contracted experimental work.  These and other published
articles detailing results using total body irradiation for its
anti-tumor or palliative effects deserve thorough reading.

      No. 5, any available patient records from the
hospitals involved.  It's unclear exactly how patients were
entered into this study.  Dr. Saenger himself has stated that he
and his research colleagues generally did not approach the
individual patients and request participation, but that this
invitation was extended by members of the medical staff from
other departments, particularly the tumor or oncology group.  We
believe it may be useful to define in those records if available
information exists, the point of contact, and what sort of
discussions may have ensued.

      No. 6, the NIH grant applications for clinical
research training funding and for funding of the research ward at
the Cincinnati General Hospital.  DASA funded the research costs
of the portions of the study, the Saenger studies that were
involved in finding the biological dosimetry and in also
evaluating the psychological and physical testing.  However, they
and Dr. Saenger agree that the DASA funding did not cover the
costs of having the patients on the wards in the hospital and
also carrying out the total body irradiation program.  It would
be helpful to see any grant applications and reviews which may be
in existence related to this other form of federal funding.

      No. 7, documentation of Dr. Saenger's role as a staff
member and later a consultant to the Brook Army Hospital,
Lakeland Air Force Base Hospital, United States Public Health
Service, and Atomic Energy Commission Oak Ridge Program during
the period 1953 to '72.  This was the period when the Cincinnati
experiments were being planned, applications for funding
produced, contracts awarded, and the contracted work was carried
out.  Information on the background appointments of Dr. Saenger
and his involvement with these different federal agencies may
help to understand the totality of the story of the Cincinnati
experiments.

      No. 8, information on similar total body irradiation
human experiments which are contracted for and carried out at the
Baylor College of Medicine and the Sloan-Kettering Cancer
Institute in New York.  Drs. Vince and Collins of Baylor and
James Nixon at Sloan-Kettering also had contracts from DASA
during the decades 1950 to 1970 to do human total body
irradiation research, and the contract numbers are listed for
you.  I won't read them now.

      In recommending approval of the Cincinnati
experiments in 1959, Army reviewers urged coordination between
Dr. Saenger's group and the New York and Texas research groups. 
Review of the contracts themselves may add to the Committee's
understanding of the background for all such experiments
contracted for by federal agencies in this time period.

      Finally, all the documents that we reviewed for you
at this point in time have been unclassified.  However, in some
instances it's clear that the reports make express reference to
the military purposes behind portions of this research.  It would
be interesting, we believe, for the Committee to know whether
investigators like Dr. Saenger had security clearances and access
to classified information in any aspect of these experiments,
planning, application, or carrying them out, and whether such
classified documentation may exist, which again would help us
shed light on the totality of the story of the Cincinnati
experiments.

      Let me conclude by saying I had assistance by
multiple members of the staff on this portion of the project,
particularly Dr. John Engel, who couldn't be with us today.

      CHAIRWOMAN FADEN:  Thank you very much, Ron.

      Let me just take this -- it should be acknowledged
that Gregg Herken and Gil Whittemore are also sitting with Ron,
have worked on this part of the staff's activities as well.

      Just to remind the Committee that the purpose for
which we requested the case presentations, this and the other two
that we'll be discussing, was for essentially methodology.  We're
not in a position, as Professor King reminded us at the first
meeting, to at this point get to the question of making judgments
about the work of Dr. Saenger or his colleagues in Cincinnati. 
The purpose now is to see how much we understand from the
information that staff has been able to put together, and the
suggestions, as Ron has pointed out, are all suggestions from
staff as to additional information and sources of documentation
that may assist in our ultimate coming to consideration of
questions of propriety and appropriateness, and so on.

      With that, let's open it up for discussion.  Nancy?

      DR. OLEINICK:  In the material that you received from
the Department of Defense, did this include any documents that
would have been prepared by  members of the Department of Defense
for their own use in summarizing the experiments of Dr. Saenger
and the results and how they might be of use to the mission of
the Department of Defense?

      DR. NEUMANN:  The material that I reviewed thus far
only directly addresses that.  Certainly the application was
reviewed and we have photocopies of the reports submitted by five
different Army officers or branches of the Army officers vis-a-
vis the applicability of this proposal.  They don't go into great
detail as to how it might be used.

      The second is the progress reports which were
provided between 1960, when the research began, and 1972 have
dissemination sheets attached to the back side, and they do
indicate which branches of the military the information was going
to.  None of it, however, was classified, and it was freely
disseminated, as far as we can tell.

      CHAIRWOMAN FADEN:  Ruth?

      DR. MACKLIN:  Forgive me if I'm supposed to know the
answer to this from reading all these materials (Laughter), but
No. 2 that you mentioned, correspondence on psychological
testing, you mentioned that the psychological and cognitive
testing component was expanded, and then you say you don't have
documents to explain the reason.  But what was the nature of the
expansion, and if you could just say something about what the
nature of the test was and what the nature of the expansion was?

      DR. NEUMANN:  In the 1958 application there is note
made that they desired to evaluate subjective responses of the
patients to the radiation.  By that, they have a score sheet
that's included in the documentation, where ward staff members
were asked to score feelings of nausea, for example, distress,
general malaise, and so forth.

      The initial study, when it started, for reasons that
are partly clear, had the patients housed in a bed on a
psychosomatic ward within the hospital, and there was involvement
by a staff psychiatrist in that initial portion of the research. 
However, there's not a detailed psychological evaluation program
included in the original experimental design that was submitted,
nor in the early progress reports is there a lot of information
of that sort which is being reported back.

      Approximately '63 to '64 in the progress reports
there's enhanced discussion of the need for this type of
information because it would potentially be of great importance
in determining effectiveness of individuals following exposure,
either from industrial accidents or, of course, in cases of
atomic war, nuclear war.

      What isn't clear is whether the desire to expand into
this area was initiated necessarily at Cincinnati by the
investigators then involved, or there may have been a request to
expand it.  I think that the degree of expansion which does occur
with a full-blown subprotocol for psychological testing, and a
number of additional staff members with professional backgrounds
in psychology and psychiatry being added, marks an addition to
the protocol that is significant and perhaps deserves more fuller
explanation.

      DR. MACKLIN:  Just as a factual question, I guess,
Susan or anyone, when were those LSD experiments conducted?

      CHAIRWOMAN FADEN:  Oh, you mean the military LSD
experiments?

      DR. MACKLIN:  Military, yes.  There was a period --

                CHAIRWOMAN FADEN:  Right.

      DR. MACKLIN:   -- during which there were not only
the LSD, but lots of so-called behavior control experiments going
on.  Now, I mean, that's very different because you're using
healthy volunteers and putting substances into them, but they do
go to the question of psychological and cognitive testing in
particular.  So I'm just wondering if that's around the same time
period.  That's just a factual question.

      CHAIRWOMAN FADEN:  The Surgeon General IG's report
makes reference to the time frame, but, again, this is the Mark
Ultra program that we heard a little bit about last time from the
CIA people who presented.  So we can certainly connect the time
frame and see if we can't put that all together, so that we can
do -- we can fix the time together and we'll give that
information back to the Committee.

      Duncan had indicated a question, and I'm just looking
for eye contact.  So either yell out or get my attention or get
Ron's attention and just get right in there.

      DR. THOMAS:  This is, clearly, one of those
experiments where I think we'd agree that there's potential for
some harm to have resulted.  Clearly, one of the points of
contention amongst the various people and organizations that have
looked at this study is whether, in fact, anybody was hurt.  My
reading of this is that's still an open question.

      It may be that this Committee will decide that it's
worth revisiting that question ourselves because I think it's an
important one for compensation issues, if nothing else.  So I
guess the question I'd like to frame is:  are you aware of the
existence of any sort of systematic listing of all of the
patients, their clinical characteristics, their outcomes, and so
on, or a computer file thereon that we could obtain?

      DR. NEUMANN:  There are in each progress reports
appended individual case reports, and that is fairly complete. 
The numbering system suggests that individuals were removed or
not fully participants.  So the numbering sequence that you'll
see is not necessarily sequential, and it takes a bit to
understand that.  But there is a medical biological type of
description of each of the cases with the followup to the point
in time at which the progress report was completed and sent off
to the funding agency.

      DR. THOMAS:  I think we could abstract a lot of this
information ourselves if we wanted to, but I suspect, given,
first of all, the historical sequence in which the data is
accumulating, together with a certain amount of judgment that may
be called for at various points along the line, that coming up
with our own listing is something that could generate controversy
in itself.

      I wonder -- I guess the question is -- clearly, the
investigators must have done this themselves at some point.

      DR. KATZ:  I think a follow-up question to that is: 
did I read Dr. Shield's letter correctly when he said that there
would be a 25 percent mortality from participation in the
experiment, his letter of criticism to the Chairman of the IRB? 
And he then offers that the authors' own series documents -- I
guess the authors of the experiment -- documents a 25 percent
mortality.  Did I read that correctly?

      DR. NEUMANN:  Well, there is a statement in there
about the correctness of the assumption of the investigators.  In
the testimony of Dr. Egilman in the Senate or the House committee
hearings of April 11, 1994, there's a more complete discussion of
that topic by Dr. Egilman in his testimony.

      He served in an ad hoc capacity to the junior faculty
committee at the time in '72 when they were looking into this. 
In terms of direct statements by Dr. Saenger or the research
staff, in several instances when he was asked the question about
premature death perhaps resulting from this, I believe Dr.
Saenger's best estimate was a calculation that eight of the
patients out of the total group may have died sooner than was
expected, and that's out of a total number of 80 or slightly over
80.  So by Dr. Saenger's best estimate, it would not have been
more than perhaps 10 percent, but there is certainly a
controversy by two other scientists or physicians in their
statements to the two committees about that number.

      CHAIRWOMAN FADEN:  Pat?

      MS. KING:  Have you finished?

      DR. KATZ:  For now.

      MS. KING:  I take it that the listing that you just
read of the additional documents that we wish to search for is
basically the request from the staff that we continue to pursue
this, with which I have no problem.  What I did not see in the
memorandum for each case study that I was particularly interested
in was what each case -- so I'll ask this of other people as
well -- what each case in particular contributed, if it
contributed anything, to help us understand some of the
methodological problems we will encounter in trying to target our
document search rather than trying to cast a broad net of all the
agencies.

      So if you could give me your view or your opinion
about some preliminary judgments that you could make about what
you need to find out more about before you can answer my question
and what you think that you've already found out about, that
would be of value to us in looking at other cases.  I'd
appreciate that.

      DR. NEUMANN:  Well, I think in my preface I said that
this example, at least so far, demonstrates the strength of
document review because we've only reviewed documents; we've not
interviewed people at length.  We have not talked at length with
any of the patient family groups other than the public statement
that occurred at our last meeting.  We have not visited the
sites.  We have not asked for any documents that were not
voluntarily offered immediately to us by agencies, and so the
story that we understand about Cincinnati now is primarily
derived by the Committee from a document, but with the caveat
that some of these documents, particularly the faculty reports,
both junior and ad hoc, were obviously produced by other means.

      The difficulty, I believe, in the Cincinnati case, in
particular, revolves in part around ongoing litigation and the
desire to which interested parties may wish to voluntarily
provide additional documents to the Committee at this point in
time.

      The second aspect that I mentioned is everything that
we've reviewed thus far was unclassified and had not been
classified for the most part.  It's not clear to us, again,
whether there may be additional information that would be
fruitful for the Committee to see that may remain in classified
materials at the present time.

      I think that the last comment I would make is,
clearly, these three case studies took the staff from the broad
drift net or drag net approach into tracing individual skeins by
virtue of having to focus on the three case studies.  And it's
been of great interest and very fruitful to us to look at the
interrelationships that may exist, the chronologic time sequences
during which some of this work was carried out, the appearance of
names of individuals in different projects, for example, and it
suggests to us certainly that this focused approach on individual
cases can be very fruitful, I think, as the Committee does its
work.

      CHAIRWOMAN FADEN:  Gregg or Gil, do either one of you
want to respond -- thank you, Ron -- to Pat's inquiry about
method?

      MS. KING:  Do the cases differ in any way?  There's a
summary in the documents here about what we learned from all the
cases.  What I'm specifically interested in is it did strike me
that the cases were different.  They were different kinds of
cases.  This one was unclassified.  In one we had an
environmental case where there's an ongoing group.  That probably
helps us, the dose -- what is it called, dose measure?  There's a
group that's been set up.

      So the cases were different in many ways, and what
I'm trying to find is if I can do a topology, if that's the
correct word, of the kinds of cases we might see or lessons we
might learn from -- are these case types or are they just
accidents?

      Am I making sense?  We do this for a purpose.  We're
not supposed to learn the facts of the case.  We're supposed to
learn some methods.  So I learned a lot of very interesting
information.  I found it fascinating to read it, but I want to
know if we learned anything to help us in our future work.

      I think that the point you made about the value of
documents, a document search itself is the kind of thing that
I've been after because that's an important thing to know, and
I'm trying to figure out if the specific case give us information
about a specific case that may not be accurate for the others.

      DR. HERKEN:  Well, one unifying aspect in this might
be the degree of military interest, and there I think you see the
interrelationship is that if the AEC's Division of Military
Application was the funder for these, this range of experiments,
that I think one might assume that there is military interest,
obviously, in the outcome.

      CHAIRWOMAN FADEN:  Dan, go ahead.

      MR. GUTTMAN:  Yes, I think that what clearly seems to
be an interesting complementary of the case is in terms of the
documents and the kinds of documents we're looking at.  The
plutonium injection, of course, was a relatively classified
affair, and while there probably was documentation in terms of
contractual documents between people who were participating at
private institutions and the Manhattan Project, it's not
clear -- I don't know if Gregg can answer whether we have them.

      By contrast, of course, the Dr. Saenger experiment
was more in the routine flow of the grant process.  So you see a
whole kind of different thing.  So, for example, when I looked at
the two boxes of plutonium, there are lots of patient notes and
patients' files.  When you look at the Dr. Saenger, you see
progress reports, grant applications, contract documents, and
lots of what Ron I think alluded to, precede it.  So that groups
of people show up at the Oak Ridge conference, the so-and-so
conference.  I think what Ron was saying is what's interesting is
you begin to see groups, and then in some cases we pointed out
you could even tie back Dr. Saenger not only to other whole body
irradiation experiments, but even to some of the early Manhattan. 
Of course, the Green Run is a different type of thing.  It wasn't
the kind of experiment where you had a grant application.

      DR. NEUMANN:  I think one final caveat is that these
are well-understood experiments by comparison, perhaps, with some
of the newer material that the Committee may have to look into. 
A lot of the work has basically been done for us, inclusive staff
and Committee, by previous groups who had an interest in this,
either because of personal initiative of individuals, family
member concerns, or other reasons that brought these particular
cases to the public's attention.  That may not at all be typical
of additional new studies that we decide to look into.

      CHAIRWOMAN FADEN:  Yes, Eli?

      DR. GLATSTEIN:  One other thing in response to the
issue that you raised about the significant death rate within a
finite period of time following the treatment, in this era in the
sixties the treatment for leukemia had a 25 percent induction
death rate within a month or so of treatment, the point being
that these treatments are -- they've got lots of side effects and
it's taken a long time to get them under control and to learn how
to use these agents, drugs or radiation, and that the death rate
that's reported here is not really out of line with similar forms
of treatment for malignant disease in the same era.

      CHAIRWOMAN FADEN:  We've got Duncan and I'm going to
put myself on the list after Duncan.

      DR. THOMAS:  That point's very well taken, and I note
that that sort of comparison between the experience of these
patients and various historical control groups is exploited in
Saenger's published papers, in the ACR report, in the medical
faculties' report, and a number of organizations that have looked
at this.

      However, I think we have to take these comparisons
with a very large grain of salt.  The issues are in some cases
technical, and I think this is a point which we want to revisit
in some detail at later meetings.

      But it turns essentially on the issues of
comparability.  This was clearly not a well-designed clinical
comparison.  There are no controls.  It's impossible really to
say what kind of experience we would have expected in the absence
of treatment in this group.

      In a sense, the junior faculty report got it right. 
In a sense, they recognized that we couldn't come up with any
sensible external comparisons, and what they did was an internal
comparison which I found very interesting, comparing the higher
dose exposures with lower dose exposures.  They didn't subject it
to any kind of meaningful statistical analysis, but I think there
are still things that could be done now to look at these data and
ask -- to revisit that question of whether or not, in fact,
survival was in any way altered by this treatment.

      CHAIRWOMAN FADEN:  Go ahead, Jay.

      DR. KATZ:  And just to add something to this
important point, being the conceptual issue, there is, as Eli
correctly told us, perhaps a mortality of 25 percent with any
treatment used at the time.  So be it, but conceptually I think
we have to make a distinction between morbidity and mortality and
effectiveness of therapeutic intervention and the fact that in
these instances the subjects were recruited for research
purposes, and that the consequences that may occur in ordinary
clinical practice have to be distinguished, even if it's the same
25 percent, from what transpires in experimental settings,
because here to some extent the subjects, the patient subjects,
are being used as means for the ends of others.  Therefore,
different considerations apply than when interventions are used
in therapeutic encounters.

      CHAIRWOMAN FADEN:  Eli, do you want to respond and
then I -- 

      DR. GLATSTEIN:  I just want to make one basic point,
and that is that there is a sequence of strategies that one uses
in the human investigation.  When you deal with a modality for
which you don't have a nice prescription, you don't know what
dose to use, we start out with what we call a Phase I study where
we acknowledge we don't know what dose to use, and we escalate
doses to the point of toxicity.  That can be defined in a number
of different ways.  But when toxicities hit, that's where you
back off.  Now you know how much dose to use.  Phase I is
complete.

      The next issue is to see:  is this treatment
efficacious?  Now you know what dose to use.  Now you recruit
patients with a variety of different diagnoses, malignant
diagnoses in this instances, and you apply this treatment to
different settings, different types of patients with basically
different diagnosis, to see if disease X responds and disease Y
doesn't.

      Only after you've gone through that kind of
methodology can you reach the point of having a control study
where you have the controls to see if treatment X, your
investigational treatment, is really better than the standard
treatment.  That's the Phase III.

      These studies were obviously Phase I, not especially
well designed; I don't wish to argue that, but it was an
escalating dose to see if this treatment had impact and to find
out how much they could get away with in terms of toxicity.  They
found that level.  They found no -- very little in the way of
findings to suggest that the treatment was efficacious, and this
study was ultimately discontinued, not because the investigators
wanted to stop, but because other people realized that this
treatment was not going any place.

      I should point out, also, that this very same issue
with the same treatment is, in fact, still being resuscitated
today as part of bone marrow transplantation, not by itself, but
the toxicity of the whole body irradiation was limited
specifically by the bone marrow.  In the modern era, with the
ability to transplant marrow or reconstitute it at least, the
whole body irradiation issue is still coming back again.

      So in the historical perspective, I don't think you
can really expect controls.  This was a Phase I study.

      CHAIRWOMAN FADEN:  Can I do this, because we are
having difficulty, I think, staying on the issue of method, which
is really the purpose of this, although I know it's very tempting
when you get a case in front of you not to go to the substance of
the case on its merits or with respect -- 

      DR. GLATSTEIN:  Well, I was trying to point out the
phases of the methodology.

      CHAIRWOMAN FADEN:  Eli, it's all of us.  I mean, it's
a temptation for all of us.  In fact, in the reports it's
relevant because at least -- I forgot which one of the reports
point out the difference between the Phase I, II, III kind of
dynamic.

      Ron, are you on this point -- 

      DR. NEUMANN:  Yes.

      CHAIRWOMAN FADEN:   -- because I just wanted to take
us back to methods before we go into the next case.

      DR. NEUMANN:  That description of these experiments
as to which phase is actually a point of contention, and I want
to remind the Committee you have to be very careful to keep in
mind that the military-funded experiments were piggybacked on the
primary experiment, and it's the primary experiment that I
believe you're trying to discuss in terms of which phase.  It
would not have been appropriate to describe the military-funded
experiments.

      In the military experiments it is correct to ask for
the control population, and it is correct to say that that's not
immediately evident.  So as the discussion evolves, keep in mind
that there's a primary protocol which we do not have
documentation for, and the committees that have dealt with this
have had great difficulty in reconstructing exactly what type of
experiment, Phase I or Phase II, it was.  Dr. Saenger gives his
own thoughts about that, and then the piggybacked federally-
funded experiments to look for the biologic dosimeter and
psychological testing component, that one is more difficult to
characterize, certainly, as to what type of phase in a classical
scheme and is more difficult to find controls for.

      So that's a point of clarification as this discussion
goes on.

      CHAIRWOMAN FADEN:  Pat?

      MS. KING:  Well, thanks for returning us to method,
because he did a lot better than I did.

      But one of the things that occurred to me from
reading this report and listening to Dr. Macklin this morning,
and Susan too, is that we've been looking at the history and
principles of human experimentation.  What we tend to emphasize
when we do that are justice, involvement of human subjects,
autonomy, et cetera.

      What this triggered for me in terms of what I'd like
the Committee to focus on to help me, anyway, is that I am blank
in my own mind about the development of research and design and
what it meant, which I consider a critical aspect of any ethical
discussion.  That's a part of what's going on here, but what I
would like to flag, and not for next time, but what we need to do
is to have some kind of understanding about evolving standards,
of what expectations were for research design and what you look
for, so those can be integrated, because I get the
impression -- but I'm a lawyer, I guess -- I get the impression
that what I understand today is a lot more fixed and well
understood, and even not necessarily understood in clinical
trials by people outside of medicine than perhaps was the case in
the fifties or sixties.

      So I'd like -- I don't know how we get at that,
except to keep flagging it in some of the cases, but it seems to
me that that's one of the issues that I picked up.

      DR. MACKLIN:  I wanted to make the same point, and I
think it goes a little bit beyond the reasons that Pat just
articulated.  Both Eli and Duncan said it's not a very well-
designed study, and you pointed to the absence of controls, and
there are probably other features of it, too.

      Now we're using the terminology of Phase I, Phase II,
and now there's Phase II/Phase III, and Phase III.  I don't even
know if that terminology was used then.  So it's partly Pat's
question, and it goes beyond saying it's not a very well-designed
study, certainly by today's standards, but I think it's important
to get at the question of what research methodology looked like
then, not only for its own sake and to measure what we're now
saying is very well-designed, because there's a distinction
between sloppy research and good research or poorly thought-out
research, which even if, forget informed consent, if you're
involving human subjects for the purpose of research and you've
got sloppy research by the standards of whatever the time it,
you're not going to get any results and you're putting people at
risk or involving them in research for no good end.  You might as
well just treat them.

      So I think it's important for us to get at that for
any clinical trials in order, then, to see whether or not what
went on in these deviated from known and accepted methodological
research procedures, as well as all the ethical things that we're
asking about, because if it's sloppy research, there are certain
other kinds of conclusions that we might draw.

      CHAIRWOMAN FADEN:  If I could summarize, what I'm
understanding from Ron's report is that as much documentation as
you received -- and this goes to the question of method -- in
your judgment collectively, the documentation is insufficient to
do a complete analysis of the case.  Is that correct, sort of by
way of summary point?

      DR. NEUMANN:  That's particularly correct in the
absence of the documents for us to examine about the design and
carrying out of the primary underlying protocol, yes.

      CHAIRWOMAN FADEN:  So one clear message in terms of
method is that we know that information of the most primary sort
is likely not to be available even for a study that's as much now
in the public consciousness, about which so much work has already
been done by the agencies and the press, and so on.  So I take
that to be an important methodological conclusion because it
means that we can assume, even where there's been a case that's
received a lot of attention, that the documentation is already
easily available to the Committee to do a good job of analyzing
the case.  I think that's the sort of big take-home
lesson -- it's a general one -- from this experience.  So we may
see if it bears out with respect to the others.

      The other thing I'm hearing from the Committee
discussion now is a plea for contextual analysis, for lack of a
word, that we need to understand -- as we look at these cases,
the information has to be available to the Committee, so that the
Committee can understand how to place that experiment in the
context of the times both with respect to ethics, which we know
we have to do, which is part of this larger issue, but now also
within the context of medical treatment, as Eli points out, and
within the context of evolving understandings of research design
and scientific acceptability, as Pat and Ruth have pointed out. 
So that, clearly, means that staff has to go beyond the documents
that are specific to the particular case study, which we knew we
had to do with respect to the ethical considerations and now
we're saying we can't do that without looking at the scientific
and medical considerations of the time.

      MS. KING:  And to the second point, though, one was
about research design.  But the second point that I wanted to
make is, because I'm particularly interested in the selection of
subjects, is that from my point of view there are lots of
important things in the nine items listed that are important, but
one of the ones that I'm very much interested in is, would be the
patient documents because I want to know if in these relatively
unclassified studies, if we're going to have difficulty getting
patient information.

      When I read that -- when I was going through all the
material you gave us on this study, I kept trying to find
information about the patients because I'm particularly
interested in why these people were selected and how they were
selected, and it became clear that it was not available.  So one
of the things that it would be critical to know, and particularly
for unclassified studies because a lot of studies are not going
to be classified, I think, would be to know if we can get this
information that you want to do on the second round, because if
we can't get it -- 

      CHAIRWOMAN FADEN:  Then we know so.

      MS. KING:   -- that's important to know.

      CHAIRWOMAN FADEN:  We will revisit exactly what to do
with this -- 

      MS. KING:  Okay.

      CHAIRWOMAN FADEN:   -- tomorrow, but that's very
helpful.

      Mary Ann, do you want to throw in one thing before we
leave?

      DR. STEVENSON:  Yes.

      CHAIRWOMAN FADEN:  Okay.

      DR. STEVENSON:  I think it's fairly important.  I
think Ron's alluded to a really important point about the way
these experiments were set up.  There was one component that may
have been quite separate from anything the government or the
defense were interested in; in other words, whether or not whole
body irradiation is efficacious and the palliation of malignant
disease.

      In essence, the government piggybacked on in the
sense that these patients are being irradiated anyway; why don't
we take some blood and urine, and whatever, and see what's
happening at a biochemical level.

      Something that's very important to gather records, as
you have done from the government agencies, but also as much as
we can from the medical community or the medical environment
where these experiments are being done to try to determine where
the driving force was at various points in time, because it may
be that the medical community decided these experiments really
aren't efficacious for palliation of this malignancy, but there
may have been some drive from the government agencies to keep
them going because they were of some interest for the other point
of view.

      So it's important to keep track of both threads and
both goals at various points in time, I think.

      CHAIRWOMAN FADEN:  Thank you.  I think that is
important.

      These are very engaging studies, but we need to go
on, remembering the focus is on method.  We have a slight shift
in the cast of characters for staff who need to come forward.  Is
it all the same?  Gregg, Ron, and Gil, bring them on.

      Now before we go on to the plutonium experiments,
Nancy Oleinick was very thoughtful in bringing to our attention
the fact that there was some information about her experiences
that might bear on the appearance of a potential conflict of
interest or a potential appearance of a conflict of interest.  We
did talk about this, and my personal judgment is there really
isn't anything here that even approximates a need for a concern. 
But in the interest of the openness of our discussion, it would
be appropriate for Nancy to mention what that is and for us all
to hear it.

      DR. OLEINICK:  Sure.  Thank you.

      I just wanted to tell the Committee of my prior
association with one of the individuals who was associated with
the plutonium experiments.  I am a member of the Department of
Radiology at Case Western Reserve University, and that department
was chaired from sometime in the late forties until approximately
1978 by Dr. Hymer Freidell, who was a medical officer with the
Manhattan Project during the war and had some participation in
the experiments -- well, not in the experiments directly, but he
was a deputy to Dr. Warren and actually had visited Los Alamos
and approved at least part of the protocol.

      So although he was not directly involved with the
injection of any of these patients or in their medical care, as
far as I am aware, he was at least peripherally involved in these
experiments, and I was a member of his department.  Other than
that, there is no association, but -- in fact, I never realized
he had anything to do with these experiments until the documents
arrived and I spoke with him.  But I just thought for the record
you should be aware of this association.

      CHAIRWOMAN FADEN:  We appreciate your doing that,
Nancy, and you set a standard now for all of us to be more than
scrupulous in considering whether there's any connection, even
remote, between any of our private lives or professional lives
and the material that comes before this Committee.  So thank you
for sharing that.

      We're going to go on, then, to the plutonium
injection experiments, and Gregg's going to give us the
background on that, staff's report on that.

      DR. HERKEN:  The staff of the Committee has received
approximately 8,500 documents from the Department of Energy
concerning the 18 confirmed plutonium injections of human
subjects that occurred between April 1945 and July 1947.  In
addition, the DOE documents contain references to two possible
plutonium injections that occurred in 1944 and confirmed six
known cases of human subjects drinking plutonium in 1946.  These
additional cases have been brought to DOE's attention and the
Department is now attempting to verify these references.

      Parenthetically, I should say that the two 1944
possible injections are probably spurious, we believe, and, in
fact, that was confirmed to me at the break.  These were actually
polonium injections.  Also, the six cases of plutonium injection
were almost certainly volunteers at Rochester.

      It's important, however, to note that the 18 known
plutonium injections were part of a much larger planned program,
the purpose of which was to find out the effects that exposure to
radioactive materials being used in the Manhattan Project had
upon human beings.  In addition to the plutonium cases, several
other human subjects were injected with polonium, with uranium,
and in one case with americium as part of this program between
1943 and 1947.

      At the end of 1946, when the controversy over this
program arose, plans had been drawn up for additional human
experiments, using other radioactive materials introduced into
the body by various other means, including ingestion and
inhalation.  In the case of the inhalation experiments, it was
recognized by those performing the experiments or proposing them
that they would also be of possible military interest because of
their relation to plans for radiological warfare.  It is not yet
known with confidence from the documents how many, if any, of
these proposed experiments were carried out after December of
1946.

      As concerns the matter of informed consent, the
documentary record is not yet complete.  However, it appears that
in none of the 18 plutonium cases was a signed release by the
subject sought or obtained.  The term "plutonium" and its
application in the atomic bomb remained a military secret until
mid-August 1945 with the publication of the Smythe report.  With
one possible exception, none of the 15 people injected with
plutonium after August 1945 was evidently informed of the
material being injected.

      In the spring of 1947, while authority for the atomic
bomb project was being transferred from the Manhattan Project to
the Atomic Energy Commission, the AEC, the subject of future
informed consent was discussed between AEC and its university
contractors.  While the records of that discussion have not yet
been located by the Department of Energy, available documents
suggest that the contractors insisted upon, and received from the
AEC, a fair degree of autonomy in the conduct of the experiments,
which extended to the matter of informed consent.

      For example, the document in the ethics section of
the briefing book that's been previously cited, dated 30 April
1947, from Carroll Wilson to Stafford Warren suggests that the
contractors may have resisted an AEC recommendation that a signed
release be obtained from future human subjects.  Instead, a
compromise was reached whereby two attending physicians would
certify in writing to the subject's understanding and consent. 
This was, in fact, the exact procedure that was followed in the
last known plutonium injection in July 1947.

      As for further research after the plutonium
injections and other possible experiments, the most promising
sources yet to be obtained from the Department of Energy include
the following:  first and primary, the 250 supporting documents
collected by the agency's Inspector General's Office in their
initial investigation of the plutonium injections in 1974.

      Secondly, the records of the AEC contractors, and
particularly the records of the universities and their physicians
which carried out the experiments under contract to the
Commission; and, finally, the records of the AEC's Division of
Biology and Medicine and of its Advisory Committee on Biology and
Medicine and their predecessors in the Manhattan Project, under
whose auspices the experiments were conducted.

      CHAIRWOMAN FADEN:  Thank you, Gregg.

      Questions?  Ruth?

      DR. MACKLIN:  This is really a very small point.  You
used the phrase "signed release," and I know that's a word that's
used in these, and you used it almost interchangeably with
informed consent, which of course we know is something different. 
I'm not criticizing you.  I'm just asking, in these documents and
when you look back -- and the correspondence you referred to
under the ethics section that did use the words "signed release,"
were the words "informed consent" used anywhere in this
discussion?  I know they used the words "signed release," and
when you're discussing it, it's kind of flipping back and forth. 
But, to your recollection, were the words -- 

      DR. HERKEN:  My memory actually is that in the
documents that it was the AEC's general counsel, Edwin Huddleson,
who used the term "informed consent," but that in the
discussion -- I should say in the letter that went back from
Carroll Wilson to Stafford Warren, who was head of the Manhattan
Project Medical Division and also the Chair of the Interim
Medical Advisory Committee that was meeting on the subject of
informed consent, that informed consent was not used in that
case.

      DR. MACKLIN:  Yes.  I mean, I think it's a small
point, but maybe it goes to the understanding.  The concepts
used, obviously, reveal things about the understanding and the
purposes.  A signed release has a very different meaning from an
informed consent.

      DR. HERKEN:  Uh-hum.

      DR. MACKLIN:  And the fact that some -- if the words
"informed consent" are not used, it has certain implications
possibly for what's understood or possibly for what people
thought the purpose of getting that signature of the subject.  So
I just point that out and it's maybe worth thinking about this
and looking at other documents from this era.

      DR. HERKEN:  One of the problems is, again, the
documentary record is not complete.  The actual report that went
to Stafford Warren, the report of the findings of the Interim
Medical Advisory Committee that was sent to Carroll Wilson and
the AEC, that report has not been located yet.  So what we have
is the document that's a response to that report, and it's quite
a revealing document.

      The report was the result of a three-day conference
among the AEC and the contractor physicians from, I believe, all
of the university contractors that are important in this case: 
Rochester, Chicago, University of California.  We would love to
find that document and we have not yet, and, apparently, the AEC
Inspector General's Office was not able to find it.  It's not
listed in their inventory of documents that they located, but we
hope it's still out there.

      CHAIRWOMAN FADEN:  You think there's a prospect,
Gregg, that it might exist?

      DR. HERKEN:  I'm pretty sure that it does exist. 
It's just a matter of finding it.  I think we will find it now in
the contractors' records which are embedded in the field offices
of the AEC, or now the DOE.

      CHAIRWOMAN FADEN:  We've got Jay and Eli.

      DR. KATZ:  Yes, just a clarifying statement:  the
term "informed consent," to my knowledge, was not used until 1957
when in the California opinion the doctrine of informed consent
was first promulgated.  So I would be surprised if in any
documents prior to -- of course, that was for therapeutic
purposes.  It will be interesting if you ever found the phrase
"informed consent" was used prior to 1957, and I did extensive
research with my students on this subject and we couldn't come up
in any case law anywhere else with the phrase "informed consent"
prior to 1957.  "Voluntary consent" or just plain "consent" were
the terms of art used.

      And, by the way, just to mention something because it
may eventually be of some importance, the phrase, the legal
phrase "informed consent" has often been misunderstood as
consent -- informed defining consent; namely, that you need the
consent of an informed patient.  Informed consent in law is a
hybrid concept where "consent," of course, goes to the patient's
acquiescence or more to the proposed procedure, and "informed"
goes to the disclosure of legation of physicians as to what a
physician must disclose to a patient.  So it doesn't have to
be -- a patient doesn't have to give an informed consent, but the
doctor is under an obligation to inform the patient, so that he
or she can give consent.

      CHAIRWOMAN FADEN:  Eli?

      DR. GLATSTEIN:  In your search, what sorts of
discussion, if any, did you find about using animals before
getting human volunteers?

      DR. HERKEN:  Oh, in fact, actually, animals were used
first.  They used rats and dogs starting as early as 1942 with
plutonium injections, but it became -- 

      DR. GLATSTEIN:  What did they think they were going
to learn from humans that they didn't learn from the animals?

      DR. HERKEN:  Well, I'm a political historian, again,
so I'm not sure I could speak with confidence on this, but I
think they found out fairly early on that there was not a
correlation -- a very poor correlation between the rat and the
dog, and they assumed, I believe from the experience with radium,
that there would also be a poor correlation between animals and
man.  I believe that's what turned out to be the case, but I'm
sure your colleagues on the Committee could speak to that with
more authority.

      DR. NEUMANN:  That's true, actually, in the case
reports of several of individual subjects that point is made,
that, in fact, the excretory patterns were different in the
animal experiments, and they cite that now as saying it's good
we -- you know, not good, but I'm paraphrasing -- it's clear that
we needed to do this experiment.

      CHAIRWOMAN FADEN:  Mary Ann, did you want to join in?

      DR. STEVENSON:  Just from my reading of some of the
materials, the jump from animals to humans was actually driven by
a lot of the workers within the field who felt that the same kind
of problem would occur if some kind of human experiments weren't
done; in other words, that there would be assumptions made based
on animals models that were incorrect.  Therefore, protection for
the workers would be inadequate.  In fact, it did turn out to be
true that the excretion patterns were very different between
rodents and humans.

      CHAIRWOMAN FADEN:  Could I ask a question that,
again, goes to method?  Gregg, you ended your comments and the
report to the Committee indicates a series of places to search
for additional documentation that could be relevant.  It sounds
like that's a lot of material that you're suggesting could be
relevant, and also that some of it is going to be potentially
quite difficult to find.

      So two parts to this question:  again, the same, at
the end of this Cincinnati experiments we are to conclude that
despite the attention that the plutonium experiments have
generated recently, and the efforts on the part of departments to
provide information to the public, the press, and to us about
those experiments in recent weeks or months, that what we have is
yet, again, an inadequate base for drawing an adequate picture of
those.

      And, secondly, do you in your collective professional
judgment know about how far we need to go with respect to the
suggestions that you've put forward, really needing to go how far
to get how much -- 

      DR. HERKEN:  Right.  Well, I think that we could
certainly target this search, and one advantage we have in this
case is that the AEC, or now DOE, did a lot of the work initially
early on in 1974, including interviews as well as collecting this
document base of 250 documents.  We don't have those 250 key
documents yet, but I think that will help resolve a number of
questions we now have.

      As well, the targeted search is going to be upon the
Division of Biology and Medicine, and, in particular, upon the
Director's files.  The first Director was Stafford Warren, who,
of course, had been the head of the Medical Division under the
Manhattan Project.  Finding his Director's files, his policy
statements are going to be key, as well as the policy statements
connected with his successor, Shields Warren.  I think if we
could target that search to look at the Director's files within
DBM, the   Division of Biology and Medicine, and within its
advisory committee, a lot of the questions that we now have will
be answered, including the question of why did the human
experimentations continue under the successor to Stafford Warren,
Shields Warren, who we know on the record opposed human
experimentation.  As a research matter, that to me is the most
interesting question.

      CHAIRWOMAN FADEN:  Uh-hum.  Thank you.

      Are there other questions?  No?  Pat, please?

      MS. KING:  I was interested in the pursuit of
documentation held by contractors.  The reason was that this
study seemed to offer the possibility of finding out how much
information might actually be within universities or contracted
out between contractors rather than in the federal agencies
themselves.  I think continuing this area would be worthwhile
just to find out if that is true or not, that we have one
additional -- or do we already know that?

      CHAIRWOMAN FADEN:  Pat, you're raising the issue of
we ought to go forward and see what the universities can give us
about these experiments -- 

      MS. KING:  Right.

      CHAIRWOMAN FADEN:   -- as a test to see -- 

      MS. KING:  Because I want to know what alternatives
we have to the agencies.

      MR. GUTTMAN:  We discussed this with DOE and they're
very cooperative, very eager to get to the bottom.  There are two
comments.  One is Secretary O'Leary in her search has put the
existing contractors on notice.  So, theoretically, they're in
process.  Of course, the extent to which is another question, but
the two interesting ones in relation -- Gregg can talk much more
informatively -- Rochester and Chicago are former contractors,
and they were at the center of the Manhattan Project.  So that's
a special case which I think we'll discuss tomorrow.

      MS. KING:  Oh, okay.

      CHAIRWOMAN FADEN:  But the point that Pat is making
is that this would be -- looking at it as a methodological test
case, we ought to pursue to see what we can get from the
universities, both to see how easy it is to get it and how rich a
source of information it turns out to be, so that we can get some
sense as we go to further issues, at least for experiments that
were done that far back, what's the point of going to
universities.

      MS. KING:  The fact that it's Rochester and Chicago
makes that even more appealing.

      CHAIRWOMAN FADEN:  Right.

      DR. HERKEN:  If I could say, it works both ways in
that the records of the AEC are embedded in the records of the
university, and the other way around.  For example, the 30 April
1947 document that was turned up by the 1974 IG report, the AEC
investigation, I found in the Bancroft papers of Ernest Lawrence. 
So this is where I think independent research will sometimes at
least wind up with documents that the originating agency itself
does not yet have.

      CHAIRWOMAN FADEN:  Reed, did you want to -- 

      DR. TUCKSON:  Just I guess that same thing applies to
the case that we have of Elmer Allen and looking at the record
there.  So you think it's possible that the original document
still exists from which this was abstracted?

      DR. HERKEN:  Well, actually, we have a lot of the
original documentation from the Department of Energy for Cal-3
who is the case, the injection of Elmer Allen.  I don't believe
at the Bancroft that much information, if anything, has come up
on Elmer Allen, but there's information on Cal-1, Albert Stevens,
for example.

      DR. TUCKSON:  It's interesting in terms of the amount
of time that went on from the time of diagnosis to the time in
which the experiment that they describe in those terms and then
two or three months later, finally, they went to the definitive
procedure that they had intended to do all along.  It's just hard
to get a sense of how he was doing and what was -- while there
was the consent that they described at the beginning, what you
don't get a sense of is what was his clinical condition and did
it change over time, and they make no note of that.  They talk
about some issues of pain at the beginning and whether or not,
you know, that continued on.

      So I would just be interested -- I don't know whether
the people that abstracted it paid any particular, you know, were
people that paid attention to the clinical course over that time.

      DR. HERKEN:  My memory is the medical records for
Elmer Allen and for a number of the injectees are fairly complete
within the documentation we've received.  So you could probably
answer that question.

      CHAIRWOMAN FADEN:  Yes, Mary Ann?

      DR. STEVENSON:  I guess I have a question.  From
reading the IG report, 1974, clearly, at least in the section
from the Division of Biomedical Environmental Research, someone
or many people went to the various sites, interviewed people, and
looked at documents.

      DR. HERKEN:  Yes.

      DR. STEVENSON:  So do you have -- and then they
abstracted and made a report.

      DR. HERKEN:  Yes.

      DR. STEVENSON:  So do you have those documents or is
it necessary to go back and look at those again?  I mean, are we
confident that whoever looked at it in 1974 did as good a job as
can be done?

      DR. HERKEN:  Actually, I think they did a very good
job.  What we have are the interview notes.

      DR. STEVENSON:  Right.

      DR. HERKEN:  What we don't have, and we certainly
would need, would be the actual copies of original documents that
they identified and made an inventory of.  We have the inventory,
so we know what they found -- 

      DR. STEVENSON:  Right.

      DR. HERKEN:   -- but we don't have the documents, and
some of the documents would be quite interesting.  Presumably,
this would be a matter of just finding the supporting files for
the investigation in the Inspector's General Office.

      CHAIRWOMAN FADEN:  But to go to the part of Mary
Ann's question that gets to burden, your reasons for why we need
to get the original documents -- remember, not all of us are
professional historians here.  So why do we need to go to the
original documents if they did, in your own view, a very good
job?

      DR. HERKEN:  I'm sorry, I didn't make that clear.  We
don't have the documents, period, the copies or the originals. 
In the case of the 250 that they found in their search, I think
nine different field offices, a total of 250 documents, they
inventoried the documents in terms of who they came from, the
date, and the general subject.  We have the inventory, but we
don't have the documents.

      The only other thing we have is the IG report itself
that mentions -- is essentially a summary of the documentation
they found.

      CHAIRWOMAN FADEN:  And we need to see the
documentation directly -- 

      DR. HERKEN:  That's right.

      CHAIRWOMAN FADEN:   -- because -- 

      DR. HERKEN:  Well, because, in fact, there's much
more information, we're convinced, in there.  Probably the issue
of informed consent, not identified as such but in substance, the
issue of consent was certainly the subject of the three-day
meeting that occurred April 3, 4, 5, 1947.  We don't have that
report.

      CHAIRWOMAN FADEN:  And we need -- 

      DR. HERKEN:  We need that report, and all we've found
so far is a folder marked "Reports, Interim Medical Advisory
Committee," and, unfortunately, it has a report from January
1947, nothing on April.  There were monthly meetings.  We'd like
to find each of those monthly meetings, but certainly the key one
in April '47 when this issue came up.

      CHAIRWOMAN FADEN:  Thank you.

      Yes, Nancy?

      DR. OLEINICK:  Unless I misinterpreted what you said,
you made a statement early on that, of course, the plutonium
experiments were part of a larger plan program involving other
isotopes and other routes of administration, and so forth, and
much of it probably didn't go on.  It was terminated.

      Do you have the appropriate documentation to indicate
that that is so or that, in fact, there is a possibility of a
much larger group of experiments out there?

      DR. HERKEN:  What we know, that the -- as the
Manhattan Project was going out of existence and giving its
authority to the AEC, there was a series of planned experiments
still proposed, and we had that in the report of that advisory
committee.  When the AEC was created, my memory is that the
Interim Medical Advisory Committee approved certain further
experiments for the injection of other fission materials or
radioactive materials.  We don't know whether those experiments
were conducted.  I think the operating assumption is probably
we're not because we don't have evidence, but that is something
on which we would like to know more.

      CHAIRWOMAN FADEN:  This, by the way, is a good
illustration of how, starting with a particular case, you get to
the wider policy and political context that really bears on the
central issues that are before this Committee, and it will be
helpful to understand -- first of all, to establish whether,
obviously, any other similar studies were conducted, and it will
be equally as revealing if it turns out that a determination was
made not to conduct them, why that determination was made, will
help us understand, I think, a great deal about what we
subsequently want to say.  So we start with a particular set of
experiments and work outward from that.

      Other questions?

      (No response.)

      Again, both this report and the report on the
Cincinnati experiments, it may look as if this was done very
quickly, but I really feel again I need to acknowledge all the
work of the staff in going through so much documentation in such
a short period of time and making it so coherent and easy for us. 
It's very nice to be spoon fed, as one could say.  I'm enjoying
this immensely from that point of view, and having such a
wonderful staff to provide us with stuff in such a concise form.

      We're going to take a break now and then come back at
3:15 for the public portion of our session, which will conclude
at this point, we suspect, at 4:15, when we will discuss the
Green Run experiment.

      (Off the record.)

      CHAIRWOMAN FADEN:  Please, if everyone will come to
the table -- we've got four people.  We need to make sure we have
time for everybody.

      Okay, I think we should just begin.

      Is Mr. Cooper here?  Do we have Mr. Cooper with us?

      We don't have to go in order.  So we can move things
around.

      Is Mr. Cummins here?  I'm sorry, it's Mr. Brown. 
Excuse.  Is there a Mr. Brown, Cooper Brown?  Mr. Brown, are you
ready?  We're ready for you if you're ready for us.  That would
be fine.  Thank you.

      We're beginning the public comment portion of our
meeting, if everyone could please take their seats.  This is an
opportunity for us to hear from people who would like to tell us
something that is important to our work.  We would like to ask
the people to present before us to keep themselves to about five
minutes, and that will give us a chance to ask some questions,
which is the most -- in many ways the most useful way for us to
learn what you can tell us.

      Our first presenter is E. Cooper Brown from the
National Committee for Radiation Victims.  Are you ready?  Ready? 
Great.

      I'll do this again.  Sorry to be rushed; we're just
trying to keep things going, so we can get everybody in.  I just
announced you without knowing who you were.  So I apologize.

      All right, to repeat, our first speaker is E. Cooper
Brown from the National Committee for Radiation Victims.  Do I
have that correct?

      MR. BROWN:  Yes.

      CHAIRWOMAN FADEN:  Very good, and we would appreciate
it if you could keep your comments to five minutes, so that we
can have about up to ten minutes to ask you questions, which is
the best way, we think, for the Committee to learn.

      You're on.

      MR. BROWN:  Ms. Chairman and members of the
Committee, my name is Cooper Brown.  I'm the Director of the
National Committee for Radiation Victims, and I certainly would
like to thank you both for giving me the opportunity to speak and
for being here and being part of this Committee.

      The Committee is, as its name suggests, a committee
of individuals, some who represent constituency organizations
that have been affected by one aspect or another of the nuclear
weapons testing program of the 1940s, '50s, and early '60s, and
the other half of the committee consists of about 12 people,
consists of professionals such as myself that have been involved
in the issue of radiation victims for an extended period of time.

      In January, with the revelations from Secretary
O'Leary, we made the decision to pursue this issue of human
radiation experimentation, and in so doing, and moving into that
issue of recognizing how it has been defined, we intend to work
directly on that aspect of the radiation victims' issue and not
try to confuse past nuclear weapons testing victims' issues with
what it is that this Committee and the Interagency Task Force has
been charged with.

      However, there are two particular issues that I would
like to have the opportunity this morning or this afternoon to
bring to your attention, because we believe very strongly that
what we have seen to date, and we certainly haven't seen all the
evidence related to either of these subjects, that both warrant a
thorough investigation as to whether or not the people, the
radiation victims in each instance, were subjected to human
experimentation without their knowledge or consent.

      Here I'm talking specifically about the people of the
Marshall Islands that were exposed to the fallout from the
nuclear weapons test and the Navajo uranium miners.  I have
submitted to the Advisory Committee some cursory documentation on
the Navajo uranium miners that I would ask the Committee to look
at and, hopefully, what I've presented is enough that it will
convince you that the issue is worthy of pursuing further.

      I also have presented you with now declassified
documents that were obtained from the files of the AEC's Advisory
Committee on Biology and Medicine, which suggests, in my mind and
the minds of others, that the opportunity having presented itself
in the Marshall Islands after the BRAVO test to study people in a
contaminated environment -- the decision or recommendation then
followed from the scientists of the ACBM to go forward with,
clearly, the objective in mind of studying these people in a
known contaminated environment without the people's knowledge or
consent.  And, in fact, those studies have continued, and as far
as I can tell, have been generally under the auspices of
Brookhaven National Labs.

      Anyway, there's a significant amount of documentation
there.  This has not been presented to any governmental agencies
nor the Interagency Task Force up until now.  I know that several
Congressmen have raised the question with the White House and
with the Interagency Task Force and that the Interagency Task
Force has been reluctant to involve the Marshall Islands issue in
what it is that you are doing.

      However, I think that what's happened there is that
they've confused the issue that is now before Congressman
Miller's committee of whether or not there was a wind shift at
the time of BRAVO that resulted in the known contamination of
people.  They have confused that issue with this issue.  This
issue is totally separate and hasn't been addressed by the
Interagency Task Force, and that is the question of whether or
not, once the scientists knew that the homeland of these people
was contaminated, they, nevertheless, made a decision to resettle
the people in order to use this as an opportunity to study people
in a contaminated environment.

      As I mention in my written statement, I personally
see no difference between basically bringing radiation to a
population such as, for example, what I understand may be looked
at in terms of the Green Run at Hanford, where you've basically
taken the radiation to the people in order to study the
subsequent health effects, dose, et cetera, and the situation
here where you're taking the people to the radiation.

      That concludes my remarks.  Thank you very much.

      CHAIRWOMAN FADEN:  Please stay with us for just a few
minutes, Mr. Brown.  Let me just make sure we all understand the
document you're providing with this is the document that has
"National Committee for Radiation Victims" on the -- 

      MR. BROWN:  I provided two documents.

      CHAIRWOMAN FADEN:  There are two documents.

      MR. BROWN:  One deals with the Navajo uranium miners. 
It has an excerpt from -- and the other is the Marshall Islands. 
The Marshall Islands predominantly consists of declassified ACBM
documents and also some selected reports from Brookhaven in the
late fifties, early sixties.  The other deals with the Navajo and
that is a selection out of Stuart Udall's book that's about to be
released and excerpts from an article that was written by
Professor Annas, I believe it is, and then the Begay -- the
decision of the Federal District Court in the Begay litigation in
which this issue is discussed.

      CHAIRWOMAN FADEN:  Thank you.  We will certainly make
sure that every member of the Committee, as well as staff, have
copies of both the documents you provided.  We're slightly
disadvantaged, obviously, because we've just received them at
this moment.  So we're not positioned to ask you perhaps as
intelligent questions as we might.  We might reserve that for
another opportunity, but we have some questions; we should ask
them.

      Jay?

      DR. KATZ:  Mr. Brown, thank you for bringing the
Navajo Indian case to our attention.  It makes my job a little
bit easier because I wanted to bring the Begay case to the
attention of the Advisory Committee.  I think we should look into
it.  I've read the opinion and, also, it should be relatively
easy to get at least some of the underlying documents that were
before the District Court and the Circuit Court.

      These documents are usually collected and stored even
at some universities.  It's possible that we have these
underlying documents at Yale.  In a sense, the Navajo Indian case
has similarities to the Tuskegee syphilis study because in these
instances there are all kinds of not-so-good reasons the Navajo
Indians were deceived, information was withheld from them, and
they continued to work in these uranium-infested mines.  The
United States Public Health Service was quite prepared to go
along with the conditions imposed on them by the uranium mine
owners, where in my view they should have packed their bags and
gone away and not conducted the studies which they did conduct.

      So thank you.

      MR. BROWN:  Thank you.  And, yes, the documents, the
underlying source documents, are available.  In fact, I talked
with Stuart Udall and he has all of those in his own personal
archives.

      CHAIRWOMAN FADEN:  Thank you.

      We have a question from Duncan.  We need to pass the
mike.

      DR. THOMAS:  Yes, I'm, too, interested in the
Navajos.  Could you clarify for me in what ways the situation for
them differed from the other uranium miners on the Colorado
Plateau who also were subject to considerable increase among
cancer rates?

      MR. BROWN:  That is not at all clear to me other than
that in the Begay decision the District Court drew a distinction
between the mines outside -- the role of the government, I should
say, in the mining operations outside of the reservation and
those that were on the Indian reservation or immediately adjacent
to it, which, as far as I can tell, had more government
involvement and, hence, more government responsibility as to the
operation of those mines.

      But someone like Stuart Udall would be better able to
answer that question than I.

      DR. THOMAS:  So other than this issue of government
involvement, the ethical issues, as far as you're aware, are
similar in those two settings?

      MR. BROWN:  The best I can say is that they may be. 
I can't give you a definitive answer, though.

      CHAIRWOMAN FADEN:  We have time probably for one more
question of Mr. Brown, if there is one.  Yes?

      DR. MACKLIN:  Maybe I should just read these before I
ask the question, but I just want to be specific, clear about the
specific contention.  It's clear to me what you're saying about
the Marshall Islanders and why this is an experiment that ought
to fall within the purview of this Committee.  It was not exactly
clear to me how you characterized the Clinton Administration or
the DOE, or whoever it was who said this does not fall within it. 
Could you just join those two points?

      MR. BROWN:  Okay.

      DR. MACKLIN:  What's their denial and what's your
contention?

      MR. BROWN:  Well, first off, it's unclear -- I do not
believe that either the White House or the Interagency Task Force
has these documents.  As the issue in the past has been presented
to them by -- whether it's George Miller or Congressman Dingell,
or whoever, it has been presented more in the context of another
issue which dealt with whether or not at the time that some of
these tests were conducted there was an intentional design to
expose people because of the knowledge of where the wind patterns
were going to go and, thus, where the fallout was going to fall,
and that type of thing.  That's not what I'm talking about here. 
This is a different issue.


      Thank you, Reed.

      I'm always so happy -- it's wonderful having so
many -- the colleagues that I have on this Committee who express
all the things that I would like to say more eloquently than I
can say them.

      Duncan has indicated an interest -- and, Lois, you
have a question as well?

      MS. NORRIS:  Very brief.

      CHAIRWOMAN FADEN:  All right.  And, Ruth, did you
have one more?  Let us just do Duncan, Lois, and Ruth, and seeing
no more hands, we'll have those three comments and then go on to
our next person.  We'll shortly run out of time.

      DR. THOMAS:  Just a quick suggestion:  it would be
helpful, when you write to us, if you could provide us some
information about the types of exposures that your members have
received or the types of settings in which they've been exposed. 
In particular, if you could emphasize those settings which you
think cannot appear to be within a mandate of this Committee that
you think ought to be.

      MR. ALLINGHAM:  Okay.

      CHAIRWOMAN FADEN:  Thank you.

      Lois?

      MS. NORRIS:  Very briefly, do you ever refer callers
to the DOE hotline?

      MR. ALLINGHAM:  Oh, absolutely.  Absolutely.  Most of
the callers, by the way -- I'm getting referrals from the DOE.

      MS. NORRIS:  I see.

      MR. ALLINGHAM:  So most of them talk to the DOE
first.

      MS. NORRIS:  It works both ways?

      MR. ALLINGHAM:  Yes.

      CHAIRWOMAN FADEN:  Last word?

      DR. MACKLIN:  Duncan almost asked my question, but
it's very similar.  That is, it would be -- of your 11,000
members, you said some are individuals and some are groups.  Do
you have -- does your organization have records or accounts of
just which kinds of exposure people believe -- I mean, which
kinds of radiation they believe -- 

      MR. ALLINGHAM:  We have a database that shows
everybody's exposure site, the year they were exposed, the age
they were, the first three illnesses that they recorded for us,
and whether their children have genetic defects or not.

      DR. MACKLIN:  Right.  I think that would be
especially important.  I mean, I don't know who's responsible for
organizing that, but if, in fact, we have the opportunity to go
to individuals or groups of individuals, you seem to have a very
good source of information for being able to look at the
different kinds of involvement or potential involvement, so that
it could, I suppose, make the work of the Committee a little bit
easier and to work with you.  So as long as you -- that was
really asking Duncan's question, but from a slightly different
way, in that you have the relevant data -- 

      MR. ALLINGHAM:  Sure.

      DR. MACKLIN:   -- that can enable us to pick, if we
wanted to make sure that we spoke to survivors from the different
kinds of exposures?

      MR. ALLINGHAM:  Sure.  I can give you name referrals
for any of the groups that you would be interested in.

      CHAIRWOMAN FADEN:  Thank you.  Thank you very much,
Mr. Allingham.

      MR. ALLINGHAM:  Okay, thank you.

      CHAIRWOMAN FADEN:  It was very helpful to us.  We
appreciate it.

      Our last presenter is Dr. Daryl Kimball from
Physicians for Social Responsibility.  Is Dr. Kimball here?  He
is.

      MR. KIMBALL:  Thank you, Dr. Faden, and it's good to
see you, members of the Committee.  It's a pleasure to be here. 
Thanks for the time this afternoon.

      I'm Associate Director for Policy at Physicians for
Social Responsibility, a nongovernmental organization based here
in D.C.  I just happened to come from the Symposium at the Press
Club on secrecy and openness, and many of the issues that you all
are going to be dealing with have been discussed there and should
be useful, I think, for you all to interact with some of the
folks who were at that meeting.  I understand you're going to be
going over there.

      PSR has long been concerned about the effects of
nuclear war, the effects of preparing for nuclear war, and we've
been involved over the past several years in investigations
concerning the Department of Energy's research on the effects of
low level ionizing radiation, particularly on the nuclear weapons
work force.  So it's with that background that we have been
following the very sad situation with the human radiation
experiments.

      I have in my written comments a brief outline of some
of the key issues of concern.  I won't go over this at the
present time.  I understand I just have a few minutes to address
you.

      So what I would like to focus on in my first
encounter with you is the issue of how the Committee is going to
operate itself, and I'm interested in actually hearing from you
more than you asking me:  how is the Committee going to operate
in openness itself?  How are you all going to reach out to
constituencies like the atomic veterans, downwinders, the
radiation experiment subjects themselves?

      In our view, in the view of Physicians for Social
Responsibility, this is a fundamental issue that you all need to
address in your first set of meetings, and it's vitally important
to the credibility of your investigation as time goes on.  The
history of health studies and health investigations concerning
America's nuclear victim and survivors clearly shows that it's
vital for there to be, as the speaker before me said, affected
members of the public involved to the greatest extent possible in
the process of investigations and studies.

      First of all, I'd just like to point out some very
basic fundamental things that would make -- would have made my
presentation here easier and would have brought in other people
to this meeting, and it is important to bring in people who are
going to help you in your endeavor in the future.

      Though the Committee is chartered under the Federal
Advisory Committee Act, you all are going to need to take an
extra effort to ensure that you're communicating to the
interested public, the professional community, and policymakers. 
I understand that the Committee staff is just getting started,
that you all are just getting started, but, first of all, I would
like to ask you to address the use of more timely and widespread
notification about your meetings, followup about what is
happening on the Committee, what the results are of your
meetings, as it seems as though you are just examining.

      It would be very useful to assemble and continue to
compile and update a list of interested and affected
nongovernmental organizations, members of professional societies,
members of historical associations, labor union representatives,
relevant federal agencies of course, and in some way or another
the people who have calling the Department of Energy's radiation
experimentation hotline.

      Another thing that we would like you to consider is
holding meetings at various locations across the country, so that
the public can have greater access to your deliberations, that
you have greater access to those people and their information and
expertise that is going to be necessary to help you in your
efforts.

      Then, finally, in terms of openness and outreach,
perhaps the most important issue is how you're going to make
available the documents that you all are already compiling which
are going to be massive, which are going to be somewhat
problematic in terms of which ones you feel, and the agencies
that you're working with feel, can be made available to the
public.

      In short, what Physicians for Social Responsibility
would like to suggest is that the Committee pursue a policy of,
to the greatest extent that your staff resources and financial
resources allow, an unrestricted approach to making these
documents available.  While this process, of course, should not
infringe upon the privacy rights and wishes of individuals who
are affected and involved in these experiments, but if there is a
perception that there are restrictions being made on the
documents that are coming into your office, that is inevitably
going to raise questions about the process and require the
Committee to explain why document access is being restricted.

      So, in addition to establishing trust and credibility
in the Committee's efforts, an unrestricted document access
policy is going to be valuable, so that outside reviewers and
investigators can assist you in your Herculean task of reviewing
the material that will be coming to you in the upcoming months
and weeks.

      So thanks for your time.  I would be happy to take
questions, if you've got the time, and Physicians for Social
Responsibility and a task force that we have of specialists who
have been examining the health effects of nuclear weapons
production and testing are ready to assist in the efforts of the
Committee and the Interagency Task Force.  I look forward to
working with you all in the coming weeks and months.

      CHAIRWOMAN FADEN:  Thank you, Dr. Kimball.  We have
time for questions or comments from the Committee, if there are
any.

      MR. GUTTMAN:  We've already been -- Dr. Kimball has
been elevated by us, but -- 

      CHAIRWOMAN FADEN:  Mr. Kimball?

      MR. GUTTMAN:  Mr. Kimball, yes.

      Daryl, we have from PSR a -- you sent over a printout
and we've got, I think, in the outreach packet a bunch of
references to other lists, and everybody that has a list that we
could possibly use, I guess we'd like to see it.

      CHAIRWOMAN FADEN:  Uh-hum.

      MR. KIMBALL:  You're referring to the list of names
that we sent over to the Committee staff?

      MR. GUTTMAN:  Right.  Uh-hum.

      CHAIRWOMAN FADEN:  Duncan?

      DR. THOMAS:  In our discussions of outreach so far,
we've been primarily concerned with trying to get information to
the Committee from the public.  It occurs to me perhaps when we
have our outreach discussion tomorrow we might want to think
about how we can inform the public about what it is we're doing. 
I think there are lessons to be learned here from the Hanford
studies who I think have gone to particular lengths to try to
inform the Hanford community about their activities.

      CHAIRWOMAN FADEN:  And we have specific answers to
the questions you raise with respect to access to documents,
field hearings, and things of that sort, all of which we plan to
do.  We hope to have some Committee meetings outside of
Washington for the reasons specifically that you indicate, and we
are motivated to, but also required to make available to the
public all the documents that become available to us, subject to
considerations about privacy concerns.  We're working through how
we're going to do that.

      MR. KIMBALL:  Uh-hum.

      CHAIRWOMAN FADEN:  That's the issue of how
practically to do that.  How quickly to do that is a separate
matter, but we're very much committed to sharing any information
that we have with everyone.

      MR. KIMBALL:  And let me make a further suggestion
which I've mentioned to the staff in recent weeks that you might
consider also.  Maybe you've discussed this already.

      There is a parallel endeavor that's going on. 
There's a National Academy of Sciences/Department of Energy
committee that was assembled a couple of months ago to look at
declassification issues related to environmental safety and
health information.  They are likely to be looking at finding out
about some of the same data declassification problems and issues
that you are likely to run into.  It seems logical to interact
with them.

      And, in addition, just at this conference, this
symposium this afternoon, several of the members of the media had
reported to the group that, despite the original effort to get
information out to reporters and the public concerning the
experiments, they are running into problems in terms of the
Department of Energy's responsiveness to their information
requests.

      So, in addition to the many requests that the public
is going to be making, I'm sure, there are also the needs and
interests of reporters, and so I hope that you all will pursue
with the utmost vigor how the agencies and how your staff is
going to handle that demand.

      CHAIRWOMAN FADEN:  Thank you.  I think if there are
no other comments or questions, we can move on.

      Since Mr. Kimball has raised the other meeting, let
me just take a moment to remind everyone that what is going on is
a symposium called Openness and Secrecy:  A Symposium on
Establishing Accountability in the Nuclear Age, which is going on
as we are going on simultaneously at the National Press Club. 
This is in cooperation with the Department of Energy and convened
by the Government Accountability Project, the Information Trust,
and the Fund for Constitutional Government.

      Staff, Committee, and Committee members have been
invited to attend an address being given by Secretary O'Leary at
5:30 this afternoon at the National Press Club.  We will convene
about in time for those of us who want to go over to hear the
Secretary speak, and also the Committee members and staff have
been invited to a reception that begins at 6:45.  The Press Club
is about five minutes away from here by cab.  For those of us who
are interested in going, it's purely an individual choice, if you
would like to go.  We're invited as individuals and Committee
members and staff; we can go as individuals if we like or not go.

      We have a dinner.  So I can stick this in before we
go.  We have a communal dinner for staff and Committee members
who would like to attend.  It begins at 7:30.  So we tried to
time it to facilitate those members of the Committee and staff
who would like to go over to the National Press Club to be able
to do that, but that's clearly just an individual choice that we
all have.

      At this point I'd like to resume the Committee's
deliberations and our final report from staff with respect to the
specific case studies, a report on Green Run, if we could get our
Green Run crew back up at the table.

      While we're waiting for them to assemble, in the same
spirit of Nancy's comments, Duncan has brought some information
to the group that began -- is information that might bear on the
possibility of a potential appearance of conflict of interest.  I
personally don't think there's anything to be concerned about in
that regard, but Duncan wishes to share it, and I think that
that's most appropriate.

      DR. THOMAS:  I just thought I should let people know
that for the last few years I've served as a consultant for the
Centers for Disease Control on the Hanford thyroid disease study. 
In that capacity, I have done little more at this point than
review a few draft protocols.  Eventually, I may be asked to
review the statistical analysis or the conduct of the study as it
goes on.

      I have been told by the White House Counsel's Office
that this does not constitute a conflict per se, but I prefer to
leave it up to the judgment of the Committee.  And if they view
it as a conflict, I'm happy to step out.

      CHAIRWOMAN FADEN:  Is there anyone so concerned who
wishes to pursue this?  No, we can take it, Duncan, that the
Committee's consensus view is that this does not constitute a
conflict of interest or appearance of conflict of interest.  But,
again, it's very good for each of us to be mindful.  It's better
to bring this up and have to collectively concluded that it is
not of significance than for it to come out afterwards and then
be more concerned about whether this was something that should
perhaps have been discussed.

      Okay, so now we have our last presentation from the
staff on the case studies situation.  We've got Gil and Gregg. 
And, Gil, I believe you're doing the presentation?  Thank you.

      DR. WHITTEMORE:  Yes, I'd like to give a very brief
presentation on the staff's understanding to date of the Green
Run, which was one of the case studies that the Committee wanted
us to look at and it also is one that's explicitly mentioned in
the Committee's charter as one to look at.

      I think it's appropriate this presentation comes
after the public comment section because that deals with the
first methodological point which I wanted to raise, which is the
issue of how did this incident come to be known anyway.  That is,
if you look at the documents, I don't think to date we have found
the word "experiment" in them, and the document is called the
specially requested dissolving or the dissolving of green metal
or the Green Run; that is, to do a simple dragnet approach which
will be discussed tomorrow with regard to the agencies' document
search would not have led to the revelation of this particular
incident.

      Instead, our current understanding is the way in
which this came to be known was through the acts of citizen
groups in the Hanford, Washington area, and they did not begin by
focusing on this particular case study.  They began with the
general concern similar to the ones just expressed over the
radiation being released to the environment.  That led to the
Department of Energy declassifying a set of documents.  So
methodologically it was a public concern surrounding one of the
AEC sites that led to an initial release of documents.

      A close reading of those documents by some of the
concerned citizens noted this reference to the Green Run.  For
example, the December 1949 Health Instruments Report mentions
that it was a fairly normal month except for Green Run which
released a lot of iodine and then it talks about measuring it.

      That investigative approach led to a second more
focused Freedom of Information Act request for documents
specifically related to the Green Run, which is the second
methodological point.  Following up on an initial general release
of documents, there was more the investigative detective approach
which requires a close reading of the documents and a willingness
to pursue various leads.  This is one example, although, as you
look through the documents for all three of the case studies, I
think you will see that these documents do begin suggesting very
specific leads to look at.

      That, then, led to a more general declassification or
a broader declassification of some of the documents related to
Green Run.  You have those included in your packet for you to
peruse at leisure.  I'll simply point out that one of those
documents comes in two versions.  It's the final official report
on the Green Run experiment, and we received two copies of that,
one of which gave the document number and then with
declassifications, and then the next one had the
declassifications themselves were revised.  We've selected some
of those pages, and where you have duplicate pages because
material that was at first classified was later declassified, it
gives you a little bit of a window into the kinds of things that
were classified.  For example, the fact that the weather did not
turn out exactly as predicted was initially something that was
whited out and classified and then later released.  If you look
at those documents, they're intended merely as a methodological
point.  We had the opportunity to in a sense let you look behind
the declassification process.

      The second major methodological issue, therefore, is
why did this particular incident take place?  If the Committee
wishes to look at the intention at the time of why these actions
took place, there are a number of other documents that illustrate
how one might go about discovering that.

      When we're dealing with the Cold War story, the real
question is:  how high up in the government do you want the
document search, the inquiry, to go to paint a picture of that
era?  And we've presented two examples -- these are documents
that were released long ago -- to illustrate that.

      The Green Run Project, as I expect you know, but I
should clarify it, was intended basically to test how well
aircraft could pick up releases of radiation either from nuclear
weapons processing plants, or perhaps from nuclear weapons tests
themselves.  That's, obviously, something that was of concern;
why in December 1949 does it become a crucial issue?

      The two documents that I refer to, one of them is in
July 1948 the CIA sends a confidential memo to President Truman
saying that it's remotely possible the Soviet Union may explode a
bomb by mid-1950, but really the most likely earliest date is
mid-1953.  Fourteen months later, they send another memo to
President Truman which basically is saying, "We may have been
wrong.  We've picked up somehow" -- and they don't state exactly
what method they used -- "signs of unusual radioactivity in the
air, and it may be from a Soviet atomic explosion."  It may also
be from the Hanford plant.  The wind is doing strange things.

      In the end of September 1949, President Truman has to
go to the American people and report to them a conclusion from a
panel of scientific experts who concluded that, in fact, it was
highly likely that the Soviets had exploded a bomb.

      Now as an historian, we can't report at this point. 
We've got documentation that gets us from the end of September
1949 to the release at Hanford.  However, the coincidence in
dates is certainly interesting, and there's a strong suggestion
that, in fact, there are documents out there that exist that, if
retrieved, would help shed light on the story.

      One example is from a classified, and now partially
released, Air Force history.  One of the pages you have includes
on it the sentence, "During late 1949 and early 1950, following
the detection of the first Russian atomic detonation, a re-
evaluation of the long-range detective program was carried out
and a new plan of operation was drawn up."  Everything else on
that page is whited out, which suggests that, in fact, there are
many more details there.

      What about Green Run itself?  I've talked about how
the incident came to be known and I've talked about the problem
of providing the context.  What actually happened?

      The basic process, as I understand it -- and now
you're listening to an historian, not to a nuclear weapons
processing physicist -- is that the reactors would be producing
plutonium.  The plutonium was encased in special metal.  The
plutonium -- the fuel now with plutonium in it would be removed
and held for about 90 days.  This allowed the short-lived
radioactive isotopes to fade away, and then you dissolve the
metal and extract the plutonium.

      What they wanted to do was to get a high enough dose
of radiation or high enough level of radiation into the
atmosphere, so it would be detectable.  That meant that you
couldn't wait around 90 days and let the short-lived isotopes die
away.

      So they decided to dissolve the metal casings after
only 16 days.  They refer to it as green metal, and that's where
the term "Green Run" came from.  There's no connection at all
with any environmental movements.  (Laughter.)  It's sort of a
biological metaphor for producing plutonium.

      What followed -- and you have some of the documents
on this -- is the beginnings of how do you try and reconstruct
what actually happened physically at that time.  And what you
discover is for the people at the time it was a little difficult
to reconstruct what happened.  How much of this -- how much
radiation would actually be released?  Well, to try and do that,
first of all, you are not waiting the full 80 or 90 days you
normally waited.  You were doing something different.  That meant
that you couldn't just pull out the books and see how much
radiation was released last month.  You had to try and understand
what really was going on with the isotope decay in this fuel at
that time, which physically is a complicated process.  You had to
try and understand what the chemical process was that was going
on as this metal was being dissolved, and you had rather volatile
and not always nicely behaved chemical reactions going on.

      They did an estimate.  They estimated approximately,
for example, 4,000 Curies of radioactive iodine would be
released.  That was a prediction, and they wanted also to measure
how much would actually go up the stack, and this gets closer to
the technical details of the experiment.  They wanted to know how
much went up the stack.  They wanted to know how much ended up on
the ground, and they wanted to know what the airplanes detected,
and thereby in a sense calibrating -- getting a better sense of
what ground detection would do and what air detection would do.

      Unfortunately, the instruments in the stack did not
work.  They were supposed to be collecting the iodine and
bringing it to the lab.  There was water in the pipelines.  The
iodine decided to stay in the pipelines, and, therefore, they
really did not know how much went up the stack at that time.

      By 1950, they had tried to reconstruct it based on
what they had found on the ground and estimated about 7,800
Curies.  That was almost twice as much as what was predicted.  A
much later, more recent reconstruction has raised that level,
that estimate of that level even further.

      The methodological point is that it's not a simple
task to try even to reconstruct what happened physically, let
alone what might have happened biologically.  The issue of trying
to reconstruct the effect of that dose on the surrounding
environment and population is something the Hanford dose
reconstruction project is now doing.  The methodological point is
that there's a large, sophisticated effort going on and that's
something the Committee needs to be aware of and a resource for
the Committee to use.

      In sum, the question is:  where would we go from here
methodologically?  A number of fairly obvious directions are
suggested by the documents.  One is an awareness and the extent
to which the Committee wants to get into the technical details or
simply accept the conclusions being created by the Hanford
Environmental Dose Reconstruction Project.

      A second is the degree and extent to which the
Committee wants to get into the issue of historical context.  As
I mentioned, exploring historical contexts can range from looking
at what President Truman was actually being told in secret and
this sort of rather shocking revelation that the Soviets seemed
to be further ahead than he had been told 14 months earlier, down
to the level of trying to reconstruct what was the planning on
the site.

      We know from documents released there was discussion
about the best time of day to do this.  The Air Force wanted the
peak release to be occurring at dawn, for purposes probably of
their own overflights.  The Health Instruments people were
preferring the peak occur at midnight, because that would be the
point at which an atmospheric inversion would try to
contain -- localize most of the radioactive material that was
being released.

      We know from the documents you've been presented that
after the experiment, Health Instruments in their official
report -- and knowing bureaucrats, you have to appreciate how
daring it might be for them to say this in an official
report -- that they would not approve of a further experiment
along these lines.  That implies that there was discussion
earlier.  It implies that their approval had been required
earlier.  All of that suggests that there may be richer sources
of documentation methodologically that is useful because it's a
way of mapping out were ethical standards applies and, if so, how
exactly were they implemented at the time.

      A further point is the need for interagency
cooperation.  This obviously involved at least the Atomic Energy
Commission and the Air Force.  It may have involved other
agencies.  Part of that is the detective story:  where might
those documents be now?  Part of it is the jurisdictional
question:  what agency now has authority to release those?

      The final comment, which really is a preface to some
of tomorrow's presentations, as I mentioned earlier, the word
"experiment" does not appear in the original documentation, and
it may mean we ought to leave it to you, but at least the
observation we can make methodologically is drag-netting
government documents for reference to the word "experiment" would
not have pulled this particular case to the surface.

      CHAIRWOMAN FADEN:  Thank you very much, Gil.

      We have time now for Committee questions and comments
about this.  Jay?

      DR. KATZ:  Have you uncovered any discussions on
concerns being raised about the impact on human beings?

      DR. WHITTEMORE:  The documents we have right now that
were released are basically all post-release documents, and they
report on measurements of biological, what they call their
biological measurements; that is, looking at plants; they
collected about five dozen different birds and small animals to
look at.  None of this rather small collection of documents
mentions that, and we don't have any of the planning documents
except one set of handwritten notes, excerpts from which are in
your materials, that illustrate that this was -- there clearly
was planning going on.

      The quick answer is no.

      DR. KATZ:  No.  Of course, I'm sure the Committee as
a whole, speaking also for myself, what I'm interested in is,
were some questions raised, concerns raised about the impact on
human beings, either directly or indirectly, through plant and
animal contamination, et cetera?  However much ultimately, of
course, this missed, were at least questions raised?

      In some of the studies that I've seen on the mustard
gas experiment, both the Army personnel involved and the
physician consultants involved just mentioned human beings in
passing, but I'll make these documents available to you, to the
Committee, and have to ferret them out.

      What's amazing is that the questions didn't even
surface for a few minutes, and even if outwardly dismissed.

      DR. WHITTEMORE:  I think, first of all, most of the
documents we have are in the nature of monthly reports; that is,
they're in a literary genre which is very limited.  With that in
mind, the fact that the Health Instruments Division actually
decided to insert that sentence saying we would not support
future experiments hints certainly that those issues were being
raised and that further efforts are needed to uncover those kinds
of documents.

      DR. STEVENSON:  I was just going to say it seems
imperative that we have both the historical and ethical documents
that are now classified.  If we could request those documents,
you have a chance of looking at whether or not the questions Jay
asked were addressed at that time, in light of natural security
concerns.

      CHAIRWOMAN FADEN:  Ruth and then Nancy.

      DR. MACKLIN:  This is a followup to that exchange. 
Under your staff suggestions for additional documentation, it's
presumed that the comment that HI Divisions would resist the
proposed repetition of the test suggests that there was prior to
the discussion of the potential hazards of such releases.  I only
wonder, might there be any other reason why they would resist the
proposed repetition of the test?  I mean -- 

      DR. WHITTEMORE:  One possibility might if they felt
they were being blamed for -- I mean, this is purely speculation,
but part of what they were trying to do was actually developing
instruments.  If you can tell from the handwritten notes, it
seems as if the instruments for this test were handcrafted, you
might say, deliberately designed for this test before the era
where you could pull these devices off the shelf.

      It's possible that part of it might be that they felt
this was asking them to do too much.  So you're correct in saying
that it's a hint there might have been discussions, but we may
end up finding that it was, instead, an overworked, underfunded
division that resented being asked to do this extra work.

      CHAIRWOMAN FADEN:  Nancy?

      DR. OLEINICK:  This is also a followup.  In the
sampling of documents that you gave us, you mentioned we have
these double sets after declassification of sections, but what's
tantalizing, of course, is there are still some sections, even
after declassification, there must be sections in there that were
not declassified.  Now no one really knows what's in there, but
that's quite tantalizing and we wonder why this material is still
classified 50 years later.

      DR. WHITTEMORE:  Right, and I am not the person
to -- I share your intrigue on that.

      DR. OLEINICK:  I just wonder, is there going to
be -- do you think there will be anybody who can uncover what
that material is, because it's obviously within a document that
is directly relevant?  And I think this is more than just
relating to Green Run.  It's, again, a methodological question. 
When you're presented with three lines on a blank page, it
doesn't seem to be terribly useful.

      CHAIRWOMAN FADEN:  This absolutely underscores the
fact that we will need to do at least some of our work, access to
material that is currently classified.  So that's pretty clear
which the case study has established.

      DR. HERKEN:  I think the reason that it's still
classified is because it's connected with the long-range
detection program, and until very recently, virtually nothing was
known about that program, and even now very little is known about
it, essentially what you've just seen that hasn't been excised. 
Hopefully, there will be more made available.

      From what we can tell, this was an attempt to mimic
the radioactive signature of a Soviet bomb of Joe 1, their first
Soviet atomic bomb.  The interesting thing is that there were
other occasions where we detected Soviet nuclear weapons tests
where we believe that there were questions raised, and there may
have been subsequent attempts to mimic that signature.  One case
would have been in August 1953 when the Soviets set off the first
hydrogen bomb.  Was there another deliberate release to see if we
could make that signature?

      CHAIRWOMAN FADEN:  Susan?

      DR. LEDERER:  Yes, a followup to that, I guess I'm
asking if, based on your examination of these documents, you've
turned up another key word that would alert us to other sort of
intentional releases of radioactivity, radiation?

      DR. WHITTEMORE:  Well, it's interesting because the
term "release" might be used, but the terms that they used in
these documents are almost -- one hates to be overly cynical, but
the terms chosen seem to be deliberately confusing, especially
requested dissolving.  I don't think anybody would have thought
of that as a keyword.  The term "green metal" possibly, if you're
familiar with the technical material of Green Run, but I think
the main lesson is that it's probably more efficient to follow
clues in documents that we know are relevant rather than to
speculate on other possible keywords, particularly when we're
either talking about terms of art or even code terms that were
deliberately designed to hide what was going on.

      CHAIRWOMAN FADEN:  Henry?

      DR. ROYAL:  Has the staff contacted John Till, who's
the head of the Hanford Dose Reconstruction Study, to see what
information he knows exists about Green Run?  He's sort of done
this exhaustive document search in order to do the Hanford Dose
Reconstruction Study.

      DR. WHITTEMORE:  There was a brief conversation with
one of the people on their staff.  Partly, the staff did not want
to jump ahead of the Committee and begin conducting our own
independent investigations, and partly my understanding in that
one conversation was that they did not regard examination of the
purpose, the documents in terms of the planning process, the kind
of ethical discussion that might have taken place, as within
their purview; that they were interested in reconstructing the
dose, not documents that were reconstructing the planning
process.  That's based on one conversation.  It certainly would
be worth following it up.

      DR. KATZ:  I have a question for Dan.  Dan, do we
have any subpoena power?  We have no -- and can we get it and
even put people under oath in terms of documenting -- 

      MR. GUTTMAN:  Ruth can answer that question, set of
questions.

      DR. KATZ:  I asked it of the lawyer.

      (Laughter.)

      CHAIRWOMAN FADEN:  There's the lawyer.  We could go
back and request -- 

      DR. KATZ:  Pardon?

      CHAIRWOMAN FADEN:  We could go back and request
subpoena power.  It was an issue that was raised at the time that
the Committee was chartered, the Advisory Committee was
chartered.  It was a judgment made by the Administration that we
not be given subpoena power.  So we don't have it.

      If the Committee believes that it really needs it to
function, we can go back and try to see if we can get it.  I'm
not sure -- this is the lawyer question -- how, as a matter of
procedure, an advisory committee gets subpoena power, but that's
a separate set of issues.  Ken, do you know?  Does it require a
new Executive Order?

      MR. FEINBERG:  Yes, and you'd have to detail,
corroborate the need, the scope.

      DR. KATZ:  Ken, that's what I was wondering about,
not general subpoena power, but just a specific kind of subpoena
power to put them under oath in order to find out what documents
are available and what documents they knew about, and at least
should tell us why they aren't making them available to us, if
they don't want to.

      So before it probably was the question of general
subpoena power, if we ask it for limited purposes and act as
President Clinton told us he wants us to tell the entire story,
and if he wants us to tell the entire story, of course, he will
give us whatever we need -- (Laughter.)

      MR. GUTTMAN:  Since Dr. Katz has asked, let me answer
the question in a very meaningful way while avoiding it.

      (Laughter.)

      And that is separate out what we're talking about. 
The documents -- and Gil and Gregg are here, and when I say there
are a lot of people that are expert in this area, but I don't
know that we have any people with the kinds of brains or
intelligence and understanding that these two do, but we're
talking about in the case of Green Run documents that are
theoretically in the possession of contractors or government
agencies as opposed to private entities.  So subpoena power is a
different issue than we were talking -- theoretically, we don't
subpoena power.  We work through the government.  Your question
about subpoena power, obviously, also goes to individual
testimony as to documents.  That's a separate issue, but, again,
to the extent that the individuals are presently with the
government, we are working with the government.  As Ruth said
earlier, we are not only assured we are going to get cooperation,
but we expect and assume that's the mode we're here.

      What we're getting to is the discussion tomorrow
morning will be focused precisely on these questions, and Gil and
Gregg may want to comment now because we have been in the case of
the Department of Energy, in particular, trying to focus on parts
of the Department of Energy which would coordinate with the
intelligence agencies and hypothetically would have documentation
related precisely to Green Run, for the reason that -- things
like Green Run -- for the reasons that seem obvious, but, also,
as Gil pointed, these are interagency efforts.  And if either one
of them wants to comment on their working approach, we'll get
into the great detail tomorrow, but on the DOE as an example or
these other agencies.

      DR. HERKEN:  In the case of Green Run, there may be a
simple way to get to it.  There's a single-volume, highly
classified history of AFOAT1, which was the Air Force
organization that was responsible for collecting the debris from
Soviet nuclear tests and analyzing it.  If we could simply get
someone with the clearance to look at that volume, I would bet
that you would have the answer to where the Green Run came from.

      Another place to look would be in the Joint Committee
on Atomic Energy Intelligence, which had representation from the
CIA, the Air Force, and other agencies.  If we could get into the
records of the Division of Intelligence of either the DOE or the
Air Force and look at the minutes of the meetings around the time
after Joe -- after the Soviet nuclear test and before Green Run,
I think we would again find where the impetus for this came from.

      CHAIRWOMAN FADEN:  So the procedure, then, would be
for the Committee, basically, to endorse that the staff proceed
to obtain those documents?  We will then, if the Committee so
makes that judgment tomorrow or if we want to do it today -- the
plan was to do it tomorrow, but we can do it today.  If the
Committee wants to tell staff go ahead and pursue these
documents, we are presuming we will get them or that someone on
the staff who has clearance will be allowed to see them as at
least a beginning first step.

      If there's a problem with that, then the Committee
would have to proceed to respond to the problem, but right now we
don't have a problem because we haven't approached.

      Gil, did you want to add anything before leaving? 
Henry?

      DR. ROYAL:  Yes, the question that I think the
Committee needs to ask itself is the scope of the Committee's
work.  Human experimentation is a very large area in and of
itself, and I think that we need to recognize that the release of
radioactive material into the environment is another very large
task to undertake.  Whether or not, by taking on both tasks,
we're going to jeopardize our ability to do any one task well is
a question I think the Committee needs to ask.

      CHAIRWOMAN FADEN:  So, Henry, you're raising the
larger question of how far we want to go with the intentional
release set of considerations in contrast to what might be
considered the more straightforward human experimentation issues,
and that's complicated by the fact that the Green Run and related
intentional releases are explicitly enumerated in our Executive
Order.

      This is probably too late in the day to take that
issue up, but we will make sure that we revisit it tomorrow
because it is central to saying to the staff put a lot of energy
into Green Run; go for those documents, or don't put a lot of
energy into Green Run because of a Committee judgment.

      Gil, did you want to respond?

      DR. WHITTEMORE:  Yes.  I think that we may also, to
break that question into two parts, want to distinguish between
trying to recover the planning process that might have led to
these releases or the degree to which ethical standards were
applied from trying to recreate what physically and biologically
might actually have happened, which in the case of Green Run is
being done by the Dose Reconstruction Project.  There's an
enormous difference, I hope, in the size of those two.

      CHAIRWOMAN FADEN:  Yes, and that's a good point.

      Ruth?

      DR. MACKLIN:  And another relevant point that was
mentioned before, and that I think was discussed at our last
meeting with the representative from the agency, is to what
extent there actually at any point was any study of human
subjects, even if that wasn't part of the intentional plan.  So
if any documents actually -- or anything that's uncovered -- can
get at that issue, despite the fact that the original intention
may not have been to study the effects on human beings, it was an
intentional release and that may have been in some way as an
afterthought and within this same period.

      CHAIRWOMAN FADEN:  Jay?

      DR. KATZ:  Henry raises an important issue that has
wider ramifications.  His question I think goes to two issues. 
One, what is in our capacity to do within the time available to
us?  What do we want to give time and focus to, and what -- maybe
not necessarily want to completely push aside, but at least
explore to some extent and ultimately recommend that further
inquiry is needed either by another committee or by the
continuation of this Committee, but then have his question
also -- raises the question:  what is the definition of human
experimentation?  I mean, there's, of course, the human
experimentation of the level of doctor-patient interaction, like
the plutonium injection experiments and the Cincinnati
experiment, and then the Green Run, of course, can also be
considered to a certain extent as human experimentation in a
wider context.

      This also made me think, and I want to alert staff to
note in which of these studies, experiments, whatever it's
called, whatever they are called, where physicians are involved,
and to what extent were no physicians involved; it was merely
conducted and initiated and supervised by nonmedical personnel? 
It's very interesting to get a handle on that issue.

      DR. WHITTEMORE:  Yes, I think just to comment very
briefly on the last point, what you're also seeing right at this
period of Green Run is the attempt to create an intermediary
group that we now call health physicists; that is, the Health
Instruments Division was there, was one of the prime areas in
which that profession was being developed.

      CHAIRWOMAN FADEN:  Yes, Ken?

      MR. FEINBERG:  I heard with interest the suggestion
that one should perhaps distinguish between use of downwinder
examples or mass exposures to demonstrate and corroborate ethical
lapses while avoiding the question of medical causation, such as
dosage reconstruction levels.  I will be very surprised if you
can do one without the slippery slope getting involved in the
other.  If you decide, if we decide as a committee that a
discussion of the downwinder example and the mass exposure
example should be analyzed for purposes of determining ethical
standards and norms, it's very difficult to simply conclude at
that point and say yes or no, because if the answer to that
question is, yes, there were ethical violations, it seems to me
that it's extremely difficult to drop the ball at that point and
not get into the impact of those violations.  You're opening up a
can of worms when you do that, as if to say there's liability but
no remedy; we're not going to get into the issue of how to
compensate people, if you decide -- I am not prejudging that at
all.  I'm just suggesting that conceptually one can make that
distinction.  As a practical matter, in terms of recommendations,
it's very hard to get into the former and do an end run on the
latter.  It's very difficult to do that.

      DR. KATZ:  I hope you tell us a little bit more about
that.

      MR. FEINBERG:  Next June.  I mean next month.

      (Laughter.)

      CHAIRWOMAN FADEN:  Next month, yes.

      MR. FEINBERG:  I have my dog and pony show next
month.

      CHAIRWOMAN FADEN:  We all have our dog and pony
shows, and I encourage the use of "we."   So that I was
delighted, Ken, when you switched from "you" to "we," because
we've got to decide this together.  All right, I mean, the
decision is not coming from anywhere; the decision is coming from
here.  So either we will do it or we won't do it, but the problem
is we've got to decide.

      So thank you, though.  Those are observations worth,
definitely worth making.  Clearly, we all ultimately have to come
to grips with what's doable in the context of a year and how we
want to shape our priorities, and this entire exercise of the
past three weeks has in the end ultimately been directed toward
helping us make informed, more informed judgments about how we
might begin to make priorities and tear down what we hope we can,
indeed, do well, given the time that we have in which to do it. 
I'm not sure that we're completely ready to make those priority
choices yet, but we'll deal with this more tomorrow for sure.

      Are there other questions for Gregg and Gil that go
to either the work that's been done so far in Green Run or
related to Green Run or related questions about -- nothing?

      Can I just ask a question sort of for our general
complete understanding?  Is it correct to infer from the work
that has been done already by staff that if we did not
have -- assuming that we made a judgment to proceed with a full
acceptance or a high priority or reasonable priority be given to
the area of intentional releases, with Green Run as an example,
which is yet a judgment to be made, but if we wanted to do that,
is it correct to infer from your work so far that if we did not
have access to classified information, we would not be able to do
that job?

      DR. HERKEN:  Presently classified.

      CHAIRWOMAN FADEN:  Presently classified information.

      DR. HERKEN:  Yes.

      CHAIRWOMAN FADEN:  Thank you.

      Okay, it's quarter of 5:00.  I assume it's okay if we
stop.  We don't need Phil today; right?  We need Phil -- we need
our designated federal official when we close the meeting, but
not when we close a day of the meeting.  So since this is not
day -- tomorrow we can't stop without Phil being here.

      Again, if anybody is confused about it and would like
to go to the Press Club and hear the Secretary speak or go to a
free cocktail party -- Committee members may leave notebooks and
materials here overnight, if you would like.  You may; the room
will be locked.

      (Whereupon, at 4:45 p.m., the proceedings recessed to
reconvene the following day.)