ADVISORY COMMITTEE ON HUMAN

                       RADIATION EXPERIMENTS MEETING
                                  FRIDAY

                             JANUARY 20, 1995

                                 + + + + +

                             WASHINGTON, D.C.

                                 + + + + +

          The Advisory Committee met in the Empire Room at the
Omni Shoreham Hotel at 2500 Calvert Street, N.W., at 8:00 a.m.,
Ruth Faden, Chair, presiding.



COMMITTEE MEMBERS PRESENT:

RUTH R. FADEN, PH.D., MPH, CHAIR

MARY ANN STEVENSON, M.D., PH.D.

HENRY ROYAL, M.D.

PATRICIA KING, J.D.

DUNCAN THOMAS, PH.D.

ELI GLATSTEIN, M.D.

LOIS NORRIS

RUTH MACKLIN, PH.D.

REED TUCKSON, M.D.

JAY KATZ, M.D.

NANCY OLEINICK, PH.D.

SUSAN LEDERER, PH.D.

PHILIP RUSSELL, M.D.

STAFF PRESENT:

     ANNA MASTROIANNI

     DAN GUTTMAN

     FAITH WEISS

     GARY STERN

     JERRY GARCIA

     JONATHAN MORENO, Ph. D.

     LANNY KELLER

     RON NEUMANN, Ph. D.

     STEVE KLAIDMAN

     WILHELMINE MILLER



                                 I N D E X



                 AGENDA ITEM                                           PAGE

Opening Remarks by Chair Faden                                            4



Public Comment Period

  Joan McCarthy                                                           5

  Charles McKay                                                          13

  Pat Broudy                                                             35



Committee Discussion                                                     42



Contemporary Agency Oversight (TAB H) by                                148

  Wilhelmine Miller



Committee Discussion:  Total Body Irradiation                           186



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



                                                                  8:13 a.m.



          CHAIR FADEN:  Good morning, everyone.

          We are about to open our meeting to the public, as is
our commitment at every meeting.  We have three members of the
public who have expressed an interest in speaking to us today.  I
must remind everybody, particularly our presenters who have not
presented to us previously, that the format that we use is ten
minutes for presentation by the presenter and then that gives us
-- we would ask the presenter, at seven minutes your little light
indicator will start to blink and let you know you have three
more minutes to close your comments or to summarize.  If we can
keep to that schedule, that gives the committee opportunity to
ask you questions and makes for a more useful exchange, we think,
all the way around.

          We have -- let me just make sure, is Ms. Joan McCarthy
here?  Is Ms. McCarthy here?  Thank you.

          Our first presenter is here so we should start. 
Please, Ms. McCarthy, if you could on up.  Good morning.

          MS. McCARTHY:  Good morning.

          CHAIR FADEN:  By the way, for the committee members,
there is material in your blue folder on the left side
apparently, that has been where our public presenters provide
material in advance.

          Good morning.  

          MS. McCARTHY:  Good morning.

          CHAIR FADEN:  We're glad to have you here.

          MS. McCARTHY:  Thank you.

          I'm Joan McCarthy, the widow of Tom McCarthy, who
participated in Operation Wigwam.

          CHAIR FADEN:  Put the mike a little bit closer.  I
think it should be on.

          MS. McCARTHY:  Tom participated in Operation Wigwam in
1955.  He died an untimely death from radiogenic cancers at age
44.  He was ill with undiagnosable symptoms from the age of 36. 
He had many of the cancers that are on Public Law 100-321,
however, the primary on his death certificate is lung cancer.

          During the week before he died, Tom told me about his
participation in Operation Wigwam, and he expressed concern as to
what happened to the other men.  The answer to Tom's question and
concern about his fellow military men came after his death from
the death bed of Commander Purdy of the ship Marion County, also
in Operation Wigwam, also dying from lung cancer.  On his death
bed, Commander Purdy called in a young neighbor, Ron Josephson,
and spoke haltingly into a tape recorder detailing and setting
down the record on Wigwam, saying, "It's too late for me, son,
but I feel that we're all left holding the bag, all those crews,
not just on my ship, but all those crews."

          Operation Wigwam detonated a 30 kiloton bomb, more than
twice the power of the bomb dropped on Hiroshima, about 450 miles
off the coast of California.  I believe that Operation Wigwam was
a human experiment, a human radiation experiment.

          From an article titled, "Operation Wigwam:  The Story
of California's Secret Nuclear War, the Enemy, 6,500 Americans,"
prepared at the Center for Investigative Reporting in Oakland,
allow me to cite from this eye witness account of the scientists
and the military men involved.  "The task force of Scripps
scientists knew that what they were readying was an experiment
and an experiment involving human life.  The chief objective of
Operation Wigwam was to determine with accuracy at what ranges,
under various conditions, a submarine or surface vessel will be
destroyed by a deep underwater atomic explosion, and second, to
determine the hazards to the ship and supporting forces."

          Quoting from the article, "In other words, the naval
personnel being assembled for the blast were unwittingly
participating in a nuclear war games experiment."  A copy of this
article has been given to your staff.

          The area in the Pacific Ocean where the bomb was
detonated was determined by the Scripps scientists to be a
biological desert.  My husband said that after the detonation for
as far as the eye could see the ocean was covered with dead
marine life.  No one could predict to any satisfactory degree the
extent and type of surface and subsurface phenomena.  No one
knew, for instance, whether the ocean would be able to contain
the shock or whether the radioactive blast would explode out into
the air and contaminate the surface.  What kind of shock wave and
what it would do to the ships was also unknown.

          AEC reports reveal that the detonation did break the
surface of the water, sending a tidal wave of water over 600 feet
high towards the ships.  Air monitors stationed at San Diego
measured a higher level of radioactivity over that city within
four days of the blast.  The radioactivity skyrocketed from ten
to 20 times normal background levels over the next nine days over
the state of California.

          As a navigator stationed on the bridge of the Mount
McKinley, my husband, I feel, was gravely exposed to the hazard
of this experiment.  He was at that site for four days after the
detonation.

          The official report on Wigwam described the spray from
the detonation as an insidious hazard which turned into an
invisible radioactive aerosol.

          And, the Defense Nuclear Agency's fact sheet on Wigwam
carefully reports that radioactivity in water from the 30 kiloton
underwater device was found some 80 miles distant.

          There is no history of any cancer in my husband's
extended family.  Not one relative has passed on from this
disease to this day.  His physician told me that it took 25 years
for his cancer to develop, and he died 25 years to the year of
this test.

          When the details of Operation Wigwam became publicly
known in 1980, Governor Brown issued an immediate call for the
federal government to publicly release the names of all
servicemen involved in Wigwam, so that they could receive
suitable medical treatment.

          To me, by not being better informed and warned of the
possible health effects, I believe my husband and the other
participants were denied the ability to protect themselves. 
Tom's life may have been extended had he been made aware and had
the proper medical tests to obtain an accurate diagnosis earlier
than four months before he died.

          What will this committee be proposing to the
Administration and to Congress that will prevent the military
from conducting experiments in the future, because to me, when
any part of our species is devalued by being used in human
experiments, it happens to us all, and to me any people that
would even consider doing such a thing must have a limited
identity with humanity, and as we are becoming more and more
aware this is dangerous.

          CHAIR FADEN:  Thank you very much, Ms. McCarthy. 
Please remain with us.  There will be some questions, I'm sure.

          Are there questions from the committee members?  Yes,
Mary Ann.

          DR. STEVENSON:  What other cancers did your husband
have besides the lung cancer?

          MS. McCARTHY:  I'm sorry?

          DR. STEVENSON:  What other cancers did your husband
have besides the lung cancer?

          MS. McCARTHY:  Thyroid, pancreatic, lymph, liver, most
of the ones that are on Public Law 100-321.

          DR. STEVENSON:  Okay.

          Do you know if any of the other Wigwam participants
have been compensated or presented their cases to the government
and been compensated?

          MS. McCARTHY:  Yes, I believe some thyroid cancer my
husband had, that's on Public Law 100-321, and there is a
veteran, I first heard from him, yes, he had thyroid cancer, he
participated in Wigwam with my husband, and I remember a
statement from his letter, he said, well, we all know, "As you
well know, Joan, it's too late for the veterans, but perhaps we
can help humanity."  I remember him from that letter.

          DR. STEVENSON:  Okay, thank you.

          CHAIR FADEN:  Dan.

          MR. GUTTMAN:  Ms. McCarthy, I've been looking at the
atomic bomb test and, of course, the experimentation, and we see
there are two kinds of things.  You see some situations where
people were put at risk and there was an understanding that they
were going to be measured and see what happened to them, and
you've got some situations where, as the atomic vets have said,
people were put at risk and nobody looked and nobody measured,
and you look backward and you say why didn't that happen, they
were put at risk.

          I'm not sure if that makes sense, but in the case of
your husband, is that two different situations?  Can you say
which one you think it was, was your husband, in your view, put
at risk for purposes of being measured or put at risk without
thought of measurement and then looking backward you say why
didn't they --

          MS. McCARTHY:  The whole thing was done without
thought, the whole nuclear nightmare was done without thinking,
obviously.  I have to think about that.

          MR. GUTTMAN:  Yes.

          CHAIR FADEN:  If I could just follow up on that, Ms.
McCarthy.

          As far as you know, there was never any effort made to
follow your husband to determine whether he was developing any
illnesses or any conditions or symptoms, is that correct?

          MS. McCARTHY:  That's correct.

          MR. GUTTMAN:  Let me ask you, you know, you've
obviously spent a lot of time on this in your efforts to get
information from the Defense Nuclear Agency, other parts of DOD
or the V.A.  Do you know whether, for example, you know, he was
studied, his blood was sampled, urine, before the test and then
after the test, things like that, those levels of detail?

          MS. McCARTHY:  If he was, I'm not aware of it.  I never
had any indication that he was from any paper work that I
received.

          MR. GUTTMAN:  Have you gotten the dosage from the DNA?

          MS. McCARTHY:  Zero rem gamma, which is the badge
readings, but what killed these guys is what they inhaled and
ingested out there, the alpha and beta rates.

          MR. GUTTMAN:  I understand, so there's a basic concern
about the reality of the dosage readings you are getting from the
Defense Department, is what you are saying.

          MS. McCARTHY:  And, could I make a comment about
smokers?

          CHAIR FADEN:  Yes.

          MS. McCARTHY:  Because it's been used to deny so many
claims, and to me smokers should have been the first one
compensated, smokers should have been the first ones compensated,
because they were the most vulnerable when they were ordered to
go out there and inhale these radioactive isotopes.  They were
the most vulnerable.

          From some of the letters I received, these guys were
ordered under court martial.  I'm thinking of one fellow in
particular, he was a pharmacist in the military, never even
carried a gun, and because he was a pharmacist and smoking he
knew about the dangers, and he resisted and he did not want to
go, and they threatened him with court martial.  He went and he's
no longer with us, he had about 32 different kinds of cancers and
died young.  He was a New Jersey veteran.

          CHAIR FADEN:  Thank you very much, Ms. McCarthy.  We
appreciate your taking the time to speak with us.

          MS. McCARTHY:  Thank you.

          CHAIR FADEN:  Is Mr. McKay here?  Good morning, Mr.
McKay.

          Oh, Ms. McCarthy, could you give us, by any chance, a
copy of your testimony for the record, if you can do that?

          MS. McCARTHY:  I will have it typed.

          CHAIR FADEN:  Thank you, we'd appreciate it very much.

          Good morning, Mr. McKay.

          MR. McKAY:  Good morning.

          I have a slight touch of the flu, so if I can't be
heard too well, please, remind me and I'll try to improve my
presentation.

          My name is Charles McKay.  I'm 69 years old. I want to
talk to you about my experience as a deep sea diver at Bikini.  I
enlisted as a 17 year old, 1943 to 1946, in the U.S. Navy as a
regular Navy person.  I was qualified as a deep sea diver, and
this helmet that you see over to my left, we were qualified in
the diving school in Washington, D.C., to go 300 feet on a
mixture of air and 320 feet on a mixture of what they called
helium oxygen, which is an inert supply in terms that it was not
absorbed into the system.  With air, nitrogen is absorbed into
the tissues, and it requires a lot longer recompression after you
make a dive.  It limits the amount of time you can spend on the
bottom because of the recompression time, and that was of major
importance in terms of the number of divers that could be put
over, and how long they could stay down in terms of the salvage
and retrieval activity that we were involved with at Operation
Crossroads and, even prior to that time, when we were engaged in
diving operations in the Pacific.

          Following the Japanese surrender on August 14th, I had
been aboard the U.S.S. Coucal, ASR 8, auxiliary submarine rescue
vessel, had a large amount of diving equipment and a diving bell
that was used in case of rescue operations for submarines.  We
initially were poised off the northern end of Japan as part of an
invasion force pending what decision the Japanese were going to
make.  That was in Wakayama in the northern part of Japan.

          We then, after several days after the surrender, headed
for Sasebo, Japan on the southern island, which was 30 miles from
Hiroshima.  So, that was my first area of location, and this was
probably a couple weeks after the explosion at Hiroshima.

          The Coucal then headed back to the United States and
refitted, and in 1946 then headed for Pearl Harbor and Maui,
where we engaged in requalifying as divers and also brought
people aboard for trial diving to depths of 200 feet, in
preparation for Operation Crossroads.

          As I recall, there was absolutely no mention in terms
of radiation activity.  As a 19 year old, 20 year old in that
time, I had no concept of radiogenic exposure.

          We then proceeded to Bikini on April 20th.  The first
test was July 1st, so we were there placing target ships in
position.

          I'd like to leave that for a moment and go ahead a
little bit in terms of being discharged in the fall of 1946 and
returned home where I started a deep sea diving business,
enrolled in the University of Maine, and then went on to work for
a major chemical corporation for what amounted to 38 years.

          However, I enjoyed good health up until 1977 to '78,
and I wasn't feeling too good in 1977.  I went to my general
practitioner and I said, "I just don't feel good."  And, he said,
"Why don't you have a barium contrast?"  I didn't know what a
barium contrast was.  I found out, and so, I took the barium
contrast and the x-rays showed polyps with black tips.  The x-ray
and the diagnosis was carcinoma.

          I said, "That's not my x-ray.  You've got me mixed up
with someone else."

          I know you all realize that in plotting your life's
course, you try to keep life under control, and I must admit that
the resistance that I was demonstrating was that I was not going
to let my life get out of control.

          The doctor was just great and he said, "Well," he said,
"there's one way we can resolve this if you don't think that's
your x-ray.  You take another barium contrast."

          The second one was a duplicate of the first one.  In
the meantime, I had a friend in the neighborhood, an RN who had
medical books which I perused in great detail trying to become a
little bit more knowledgeable about what I was confronted with. 
I did find out that the area that this supposedly had affected
only six to 15 percent of the cancers occur in this area.  I
further was resisting, this to lose control.  I then borrowed the
x-rays and went 15 miles away and made an appointment with
another doctor, asking him for his opinion.  He subtly said, "You
better get yourself in the hospital right away, get taken care
of," which I did.

          While I was in intensive care and a short time after
that, a friend of mine brought me in a February 5, 1978 issue of
the Washington Post, and, coincidentally, there was an article in
there which I included in the material I left with you, that
said, "Deep sea diver at Bikini dies from cancer after 23 years,
after being exposed to Bikini ...," the way I read it after the
first shot, which was the Able Shot.

          This was the first inclination that, perhaps, that
there was a correlation here.  I had been brought up in Bar
Harbor, Maine, Acadia National Park, pristine area as a
youngster, no industry, just a magnificent area of valleys and
mountains and wooded, just a fantastic area to be brought up in. 
Most of my career up to that time had not been exposed to any
areas of concentrated industry where there would be any question
on my part that I had been exposed to some contaminants.

          I proceeded to concentrate on trying to survive for the
next five years, which is what the doctor had indicated the
timing period was in terms of any reoccurrence.  Some of you may
have experience in that area.

          In 1983, I joined the National Association of Atomic
Veterans.  I had survived the five year period.  I also, in 1985,
going back to a question that, Dan, you had asked previously of
Ms. McCarthy, whether I had applied for a dose estimate.  I did,
and it came back as 6/10ths of a rem.  In the data, there was no
reference, it was mostly general, and did not relate to the
specific job I had as a deep sea diver.

          I'd like to go back to Operation Crossroads now, and
just give you a brief overview of some of the work that I was
personally involved with.  The first test, Able, happened on July
1st.  It was a 23 kiloton explosion.  It sunk a number of ships,
including the Japanese cruiser Sakawa.  That ship, when we came
in to the lagoon, the explosion was at 9:00 a.m., just under four
hours we were at the entrance to the lagoon, and at 7:55 p.m.,
after placing several radiological boarding parties aboard
several ships for a very brief period of time, we then anchored
in the lagoon at about 7:55 p.m.

          The Able explosion was 515 feet above the target ships. 
The Army/Air Force bombardier missed the target ship Nevada by
2,000 feet, and sunk a number of ships that had instruments on
them that, of course, was facing the Nevada in terms of measuring
the intensity of the explosion and also the amount of
radioactivity plus other things that they were interested in.  In
addition to the loss of a couple of ships, the U.S.S. Gilliam and
the Lamson, the Japanese cruiser Sakawa was also in a sinking
condition, and they put people aboard trying to pump water out of
it to keep it from sinking because, obviously, they wanted to
have an assessment of the damage.

          But, the miss of the bomb really posed a problem for
them because of the loss of a lot of this measuring equipment. 
That was the reason for trying to save the Sakawa.  

          They did put people on board, but the radiological
levels were so high that it later sunk that day. 

          On the 20th of July, as near as I can tell, I made a
dive on the Sakawa.  At that time, they were using dosimeters
that they placed in the sleeves of our diving suit at a waist
level and then one in each shoe to record the amount of
radioactivity.  You would then come up and they would place these
in the Geiger counters and record the amount of radioactivity
after the fact.

          However, a short time after that they were able to take
an ionizing chamber and place it in a brass tube, which they then
fastened to the backs of the divers, and when they went down they
would press their back up against the hull of the ships to read
the amount of radiation in that area.  And, as near as I can
calculate from the log of the Coucal and the extensive research
work that I did, and also official reports of activity put out by
the government on Operation Crossroads, and Jonathan Weisgall's
excellent book on Operation Crossroads, I believe I went down
that day with this ionizing chamber on my back and placed it
against the Sakawa.  All of a sudden, over the radio of the
diving helmet came the word, "Mac, that's hotter than hell, get
away from there."

          Apparently, this attempt to try to recover and retrieve
these instruments off this ship was not possible because of the
high level of radiation that existed at that point.  So, there
were no further dives made on the Sakawa I think until the
following year when they had another group go back.

          The ionizing chamber with the immediate readings,
because of a coaxial cable going up top, were then put out on a
esterline angus recorder, which is similar to a recorder, I
think, that records earthquake.

          I talked with Boley Caldwell, who is a radiologist, I
think he was 18 or 19, that was on the Coucal, and he said that
to his knowledge they have not been able to find these records of
the individual divers to record the amount of radioactivity.

          On July 30th, following the Baker blast, there are a
number of dives that we made on submarines that had been anchored
by us for the Baker test at various levels under water to assess
the damage to these submarines at various levels under water. 
The submarines survived very well because of the double hull
construction that they had in terms of the blast, but a number of
them were heavily geiger sweet, as they would use that
expression, in terms of the amount of radioactivity.

          I do not recall at that time that they continued to use
the dosimeters and the ionizing chambers in terms of measuring
the radioactivity.  We could have.  So, essentially, that was the
amount of exposure that we had in terms of those tests.

          I'd like to now go to my observations in terms of
relating the attack of cancer, the latency periods and
significant malignancy of most studies correlate with the
pathology report and the operation based on my age at 52 years. 
The interesting thing is that the report recently put out by the
National Association of Atomic Veterans, by Robert Campbell, in
terms of the latency period of about 33 years, and also the
report that was put out by the Japanese in 1993, correlate with
the timing in terms of the incident of carcinoma that I have. 
You have copies of those reports.

          In prior testimony, Pat Broudy, the legislative
director of the National Association of Atomic Veterans, and the
work that Oscar Rosen, the Commander the National Association of
Atomic Veterans, in terms of trying to define the relevancy of
the dose estimates that had been given, have not been too
successful.  And, Pat Broudy testified to the fact that studies
by the National Academy of Sciences, Defense Nuclear Agency,
Centers for Disease Control, what have you, that some of these
studies have been flawed, that the Navy review in terms of the
dosage that has been passed out, and particularly in my case, I
don't think is relevant because it didn't take into consideration
the diving exposure that we had.

          The dose reconstruction by the contractors hired by DNA
does not include alpha and neutron exposures, that's been
testified to before.  And, of course, these are 20 and ten times,
respectively, more harmful than gamma exposure.

          SAIC, Science Applications International, government
contractor, has admitted under oath that in some instances that
they did alter the radiation dose estimates.

          President Truman was quote on April 12, 1946, calling
the tests a laboratory experiment.

          CHAIR FADEN:  Mr. McKay, would it be all right with you
if we started by asking you a few questions at this point?

          MR. McKAY:  I'm sorry?

          CHAIR FADEN:  Could we begin by asking -- could we ask
you a few questions?

          MR. McKAY:  Yes.

          CHAIR FADEN:  We're running a little short of time, and
I just wanted to ask one to start things off.

          I just want to verify again, in your instance, there
was no attempt to follow you medically by the services after you
left?

          MR. McKAY:  I have had no contacts from the services.

          CHAIR FADEN:  Are there other questions for Mr. McKay? 
Yes.  Thank you, Lois.

          MS. NORRIS:  You said that at the time that you left
Pearl Harbor heading out on this operation, you had received no
prior information with respect to anticipated exposures to
radiation or the effects of radiation.

          MR. McKAY:  No.  As I recall, going back 49 years, I
don't recall any discussions or any forewarning on any aspects of
preventative information with respect to the type of exposure.

          MS. NORRIS:  And, that carries through all the way
through the operation.  I mean, they didn't tell you before you
went down that --

          MR. McKAY:  Yes, it did.

          I'd like just maybe to summarize, saying that based on
my personal experience and study of Operation Crossroads, I
firmly believe we were placed in harms way, and that we were
considered expendable if that was the outcome, in order to get
the job done.

          And, we were experimented on, and if you go back to
Jonathan Weisgall's testimony before you on July 5th, and you
have a copy of this summary, and I've quoted two paragraphs from
his book, or his testimony rather, and there was one particular
paragraph in here, or one statement, it says, "Although the
documentary records of Operation Crossroads do not suggest a
conspiracy to cover up the test results, they do show a
deliberate decision by the scientific and medical experts to
refuse even to consider the possibility that a serviceman's
presence at Bikini might later result in radiogenic disease."

          I did include a copy of a letter that goes back to that
time frame, even in June of 1946, before the tests were
conducted, that there was considerable talk on the part of the
Navy medical group about making sure that there was follow up in
terms of the survivors from the Hiroshima Nagasaki, and there is
also reference to the fact that there should be follow up in
terms of that aspect of exposure as associated with Operation
Crossroads.

          I consider myself very fortunate to have survived, and
my testimony today is dedicated to all the military and civilian
personnel who have been radiogenic exposed, living and dead.  I'm
proud to be a member of the National Association of Atomic
Veterans and other organizations who volunteer their time and
resources to support legislative efforts to obtain justice and
compensation for widows and genetically affected children of
atomic veterans who are ill or deceased from radiation-caused
cancer illness, and also to continue to support the downwinders
and human experimental victims and others by uncovering the truth
and demanding accountability.

          My sincere thanks to the committee for allowing this
time to share my experiences and thoughts with you.  I tell you,
God bless your endeavor and the contribution that you are making. 
Thank you.

          CHAIR FADEN:  Thank you very much, Mr. McKay.

          Dan?

          MR. GUTTMAN:  Just one quick question.

          CHAIR FADEN:  One quick question.

          MR. GUTTMAN:  One quick comment.  In the 1950s, at the
Nevada test site, they gave psychological tests to people, as you
know, and one of the questions was, some of the ships in the
Bikini tests had to be sunk because they were too radioactive to
be used again, what would your answer be?

          CHAIR FADEN:  It's a true/false test, Mr. McKay.

          MR. GUTTMAN:  True/false test.

          MR. McKAY:  If I understand your question correctly, I
departed the U.S.S. Coucal on August 31st.  I really think that
saved my life.  That ship was "radiologically suspect," all the
sailors that were on that ship stayed on it, towing one of the
submarines back to Pearl Harbor, and subsequently it wound up in
San Diego.  It was still radiologically suspect at that time, and
they claim that in the early part of '47 that it was then
cleansed.  I think there's a lot of question about that.

          CHAIR FADEN:  Mr. McKay, do you know if any ships were
sunk because they were thought to be --

          MR. McKAY:  Yes, it was.

          CHAIR FADEN:  -- were there other ships that were sunk
intentionally because they were so hot that they thought --

          MR. McKAY:  It was -- no, I think that was kept in
operation for a number of years prior to -- and then it was used
for target practice, I believe, some time later on.  I have that
data.

          MR. GUTTMAN:  Just to be clear, when they gave the test
the answer to that question was, the correct answer was false,
but the correct answer according to the Army in 1951, some of the
ships, the tests had to be sunk because they were too radioactive
to be used again was false.

          MR. McKAY:  What specific ship are they are referring
to?

          CHAIR FADEN:  They are not.

          MR. GUTTMAN:  All the ships.

          MR. McKAY:  Oh.

          CHAIR FADEN:  This was in the context of trying to
instill in the soldiers a positive or a comfortable attitude
towards being involved in a bomb test.

          MR. McKAY:  Yes.  I don't think there's any doubt that
they were faced with a tremendous problem, and the sad part of
that, in addition to the ships, but some of the submarines they
brought back, where they put the crews back aboard, and those --
from the information that I've read in the research were still
heavily contaminated, because when they got back to San
Francisco, to Mare Island and so forth, those ships were roped
off, as you know, although Pat Broudy can tell you very
specifically that it was used for part of the study of the
radiological schools that were conducted at that time to train
people to be radiological monitors out, eventually, in Nevada,
where Chuck Broudy was there.

          So, there's absolutely no doubt that the crews that
were put aboard those ships to bring them back at that period of
time, both the regular ships and the submarines, that they were
still heavily contaminated, which is further supported by the
fact, as you've indicated, that some of them were so bad they had
to take them outside San Francisco and sink them.

          MR. GUTTMAN:  We know from Jonathan Weisgall's book --
I was just trying to get your reaction to the use of -- I guess
what we're asking is, we know, and we can find out from the Navy
and Jonathan Weisgall what happened in the ships, but your
reaction to, I guess, the attempt to convey the impression that
because no ships were sunk, if that were the case, something
wasn't dangerous.

          MR. McKAY:  Yes, and it raises the question that some
of them were sold for scrap, but why weren't these sold for
scrap, as opposed to being taken out and sunk?

          CHAIR FADEN:  Henry.

          DR. ROYAL:  To me, it adds more confusion than light by
using words like dangerous and heavily contaminated.  Surely,
there must be some objective data about what the levels of
contamination were, because I think the problem is, someone might
use the word heavily contaminated to mean one level of radiation,
and someone might use the word heavily contaminated to represent
another level, and so, whether there is or is not a disagreement
about the levels of contamination cannot be determined by how
people use words.

          MR. McKAY:  I think that's a good -- I think that's an
excellent point, and it can be readily resolved by getting some
of this classified material disclosed.  

          DR. ROYAL:  Anyway, my question was, do we know what
the levels were on the ships?

          MR. GUTTMAN:  I think -- well, Jonathan Weisgall
actually does as good a job as anybody, we have that book.

          MR. McKAY:  Yes.  It's just an outstanding -- you know,
the whole challenge is that, if you go from Crossroads to Bravo
Shot, which Jonathan Weisgall has talked with you, that was a 15
million ton TNT explosion.  He said in his book that was
equivalent to a train that would stretch from Maine to California
and each railroad car was loaded with TNT.  You go from there to
the Nevada tests, what the downwinders were put under.  You go
from there to Agent Orange, you go to the Persian Gulf, in terms
of exposure to depleted uranium, and you have this whole pattern
of expendability on the part of military people who can't -- are
not in a position to say no.  

          This is repetitive, I know that, but --

          CHAIR FADEN:  No, it's all right.

          MR. McKAY:  -- it continues on, and I hope that in
terms of the work that you are doing, in terms of human
experimentation, is a decision that someone made at some level,
and then washed their hands of it, and people then moved on to do
it.

          I think that's the tragedy of this, because it
continues on and there's no accountability.

          I thank you so much.

          CHAIR FADEN:  Well, thank you for your testimony, Mr.
McKay.  We appreciate it very much.

          We have our third presenter, Ms. Broudy.  Welcome
again.

          MS. BROUDY:  I know you are probably getting a little
tired of my constant attendance at these tests, and all the paper
that I churn out.

          When you discuss the issue of sinking of ships, the
Independence, which was taken to Mare Island, had been put off
limits by Colonel Warren because it was so heavily contaminated
with plutonium, that was the ship, along with another at Mare
Island, that my husband had to go aboard as part of his rad
schooling.

          And, I have presented this material to you, and I hope
you've read it, about the Independence.  That's just an aside.

          Right now, my presentation is going to be on an issue
that probably doesn't directly fit into your charter, but it is a
result of your charter restrictions, and that is the children and
grandchildren and offspring forevermore of the atomic veterans
and other people who have been exposed to radiation.

          The subject of radiation experimentation would not be
complete without the inevitable follow up, genetic effects,
mutations, birth anomalies and sterility, in the families of the
subjects of radiation experimentation.

          The September, 1946 recommendations of the Manhattan
Engineer District Advisory Committee recognized that radiation
could cause genetic effects, as manifested in the development of
abnormal individual types from changes in the hereditary
mechanism, histopathological changes, as demonstrated by abnormal
changes in the makeup of various body tissues, physiological
changes produced by the alteration of the normal functioning of
animal tissue, and biochemical and encymetic disturbances.

          As little as .5 rad for 24 hours a day for three months
may cause progressively increasing sterility, which does not
promptly disappear, and which upon disappearing may still result
in defective children in successive generations.  Such daily
exposure for less than three months may cause defects in children
of the first and second generations.

          One point rad a day for four to seven months causes a
progressive anemia, which as susceptible cases may continue to be
progressive, even when exposure is stopped.  There is good
experimental evidence to show that in some tissues there is never
complete recovery from radiation injury, no matter how small.

          The majority of personnel exposed at Bikini are young
and their heredity is of prime importance to them and their
families, and that is a direct quote from Colonel Stafford L.
Warren, Colonel, Medical Corps.

          The Committee for Biology and Medicine, April 5 and 6,
page 15, 1954, Atomic Bomb Casualty Commission, "Doctor Bugher
spoke of the termination of the current genetic program, and with
the reorientation of a new program to concentrate on data on sex
ratio.  The aim of the genetic program is to investigate the sex
ratio among newborn children in Hiroshima and Nagasaki in
relation to parental exposure to the atomic bombs."

          In connection with the discussion on genetics, the
Committee agreed unanimously that the analysis of the genetic
data should be made in the United States and at the University of
Michigan under the direction of Doctor James Neel.  

          The Children of Atomic Bomb Survivors, A Genetic Study,
edited by James Neel and William S. Schull, page 47.  At the time
this program was initiated, Japanese birth rates were at record
levels.  However, in 1948 and '49, the Japanese government
electedly, as a result of a disparity between population and
available food resources, authorized legal abortions by
physicians.  In 1951, approximately 300 pregnancies were aborted
each month in Hiroshima alone.  Because of this and possibly
other measures, the birth rate in Japan underwent one of the most
spectacular declines ever recorded in a civilized country. 
During the first five years of this study, there was not only an
absolute decline, but in Hiroshima there was also a tendency
toward a decrease in the numbers of infants born to more heavily
irradiated parents.

          By 1952, the annual decline in the amount of data
available had reached the point where serious reconsideration of
the program was indicated.  The Committee on Atomic Casualties
suspended the study in February of 1954, when Doctor James Neel
left Japan, taking the study with him to the University of
Michigan, where for over 40 years he conducted the study as a sex
ratio study, not as a mutagenic or genetic study.

          He found 75,000 children whose parents were irradiated
by the two blasts had -- I'm getting confused here -- he has
found no evidence of any genetic effects at all in the children
who were conceived after the blast, no genetic diseases, cancers,
or congenital abnormalities.

          This data was obtained from when he was critiquing
Doctor Gardner's study of the Sellafield leukemias in England, of
which you may be aware.  In accord with Doctor Gardner's study,
children of father's exposure at Sellafield in England caused a
number, an exceptionally large number, of leukemias and lymphomas
in their offspring, and I think that's going to do it as far as
the children are concerned.

          I do again want to mention the issue of the ships that
were sunk.  The Independence, after the schooling feast, were
taken out to the Farrallon Islands, which is off the coast of
California, San Francisco, and sunk with a lot of other nuclear
garbage.  That is a nuclear desert, that area is right now.  The
sand that was used to sandblast those ships was also sold as
scrap.

          The ships that weren't sunk were sold as scrap.  I have
the names of the scrap dealers.  I tried to call and, of course,
they are out of business now, but that probably answers your
question as to what happened to some of those ships, either they
were sunk at Pearl, or they were sunk in Kwajalein, or they were
sunk at the site in Bikini, or they were sunk at Bremerton, San
Diego or Mare Island.

          CHAIR FADEN:  Thank you, Ms. Broudy.

          Are there questions for Ms. Broudy?  

          Thank you very much.  We appreciate your coming in.

          MS. BROUDY:  You are welcome.

          CHAIR FADEN:  Okay.

          It's always hard to shift from the public testimony to
the rest of our business, and, actually, that may work out okay. 
Let me suggest the following.  It's a little bit early for a
coffee break.  On the other hand, Allen Buchanan was busy last
night rewriting stuff, and has some material.  That's take a
reading break.  We'll distribute it, if you want to get a cup of
coffee or stretch, take about ten minutes.  It's also a way to
kind of shift over from the focus of the public testimony, which
is very personal, to our work.

          (Whereupon, at 9:03 a.m., a recess until 9:14 a.m.)

          CHAIR FADEN:  Okay.

          Would the committee members please come to the table? 
Ruth had asked, we will have a break for some people who need to
check out of their hotel, we will still have the break at some
time mid-morning.

          But, if we could begin our deliberations.  Okay.  If we
can begin, please.  Thank you.  I'm going to buy myself a gavel
before the committee is over.  All right.

          As we noted yesterday, we are not going to follow the
agenda precisely as we had it in our briefing books.  We are
going to pick up with the discussion as we ended it up yesterday
and see how far we can go with it.

          Allen was kind enough to work last night and try to
construct the material for us that we have just read, so why
don't you start us off and then we can pick up remembering the
discussion yesterday, we were trying to feel our way around
questions of individual culpability and culpability of
professions, in contrast with culpability of the government.

          DR. BUCHANAN:  Right.  We had been talking about issues
of accountability in bureaucratic organizations, and that's why I
developed this little very sketchy, inadequate handout that I'd
like to talk about in a minute.

          But, if I may, I'd like to tie up a couple of loose
ends from the last discussion.  One thing that was pointed out to
me by a member of the staff during a break yesterday, when we
were talking about the problem of evidence, I think I may have
overstated one claim about the paucity of evidence.  What I was
saying was that in the paper, the long paper that you have, I had
concentrated more on questions about judgments in individual
culpability at the top of the chain of command, questions about
whether Charles Wilson could reasonably have been expected, not
just to formulate a policy, but to do something to ensure that it
was carried out, and whether, in fact, there is evidence that
he'd done that.

          And, I may have conveyed the impression that I was
making a blanket judgment or that I thought the committee was
making a blanket judgment that there was not adequate evidence
for judgments of individual culpability anywhere further down the
line.

          And, I guess what I'd like you to consider is that you
shouldn't jump to that conclusion.  I mean, suppose that it turns
out that there's good evidence that a particular physician
subjected his patients to risky doses of plutonium that were
thought to be or known to be likely to cause harm, and that this
was done without expectation of therapeutic benefit, and without
consent of the patients.  Now, if you assume, as I argued in the
paper, that the Hippocratic tradition, quite apart from the
Nuremberg Code, imposes an obligation on physicians not to harm
their patients without promise of a favorable balance of
beneficial consequences, at least not without their consent, then
it looks like you would have reason to say that this physician
violated a fundamental principle of medical ethics that was
acknowledged at the time, not just projected backward in time.

          And, I don't know, but the committee should be in a
position to know now, if not now then soon, whether there were
instances like that.  I guess what I'm saying is that, we just
have to avoid sweeping generalizations, either that there was no
evidence sufficient to ground judgments of individual culpability
or that there was evidence all over the place for all sorts of
judgments of individual culpability.  And, I think it's going to
be important to focus on particular cases.

          What I'm really worried about is the possibility that
the committee might make a very general statement that, though in
principle judgments of individual culpability are coherent and
defensible, we just don't have evidence for any such judgments. 
And, I think that if that kind of general statement were made,
the committee would really open itself up to severe criticism,
and probably rightly so.  Instead, it might be advisable to look
at the cases where there's the best evidence and ask whether the
best is good enough, look very closely at individual cases and
see whether there is adequate evidence to ground a judgment of
individual culpability.

          And, remember, this is not a judgment of criminal
liability.  The standard of evidence is not the same as in the
criminal law.  It shouldn't be something like, you know, guilty
without any reasonable doubt.  These are ethical judgments, not
judgments of criminal law.

          So, that's one point.

          DR. THOMAS:  Allen, can we just ask a question?

          DR. BUCHANAN:  Yes.

          DR. THOMAS:  My recollection of the discussion in which
this question came up yesterday was more in the context of the
intermediaries in the bureaucratic chain.

          DR. BUCHANAN:  That's another point, too.

          DR. THOMAS:  Pat made the suggestion at the end of the
day yesterday that we really should separate our discussion of
professional culpability and bureaucratic culpability.

          DR. BUCHANAN:  Right.

          DR. THOMAS:  I think there may be a substantial problem
in assigning culpability at the different levels of the
bureaucratic chain, and I was intrigued by the comments which you
are going to get to next, I assume, on this memo you just
circulated to us.

          Setting that aside, I think I would very strongly agree
with you, there may well be instances where we may find either
the medical profession as a profession culpable, or even
individuals within the profession.  And, it's my own reading of
the evidence that we, perhaps, might be prepared to make that
judgment.  

          I've been recommending to the Remedies Subcommittee
that we, in fact, try to develop some one or more test cases,
along the lines of some of the other test cases that we've talked
about earlier on, as a way of actually working through this whole
process of trying to establish a judgment.  So, I mean, I
strongly endorse that suggestion of your's.

          DR. TUCKSON:  The question I had is on this legal
business.  I think you are -- I mean, you absolutely have got to
be right that what we say does not have the weight of legal
judgment and so forth.  But, what hangs over my head as I hear
that, and I need you to disabuse me of this, is the notion that
what we say will ultimately have impact in the judicial system,
because if we make findings or decisions won't they in some way
be used in court cases.  They will be cited and referenced, and
thereby influence the ultimate judicial decisions that are coming
in a variety of other kinds of cases.

          Should I be concerned, am I right and should I be
concerned about that?

          DR. BUCHANAN:  Well, actually, Ruth Faden, you may want
to speak to this too, but I guess I think that there probably
will be some influence on later court cases, if there are such,
but I think that this has happened before in bioethics, I mean,
the President's Commission, for example, issued reports and the
earlier Belmont Report issued a report which was a report that
made ethical judgments and distinguished between ethical
judgments and legal judgments.  And then later, there were cases
where legislation was formulated and justified on the basis of
points that have been made in those commission reports, and some
cases in which there were rulings by judges which cited ethical
arguments, say, from the President's Commission reports.

          But, I think the legal system is equipped, and the
adversary nature of the system is equipped, to be able to
distinguish between ethical judgments and legal judgments, and I
don't think that it's even correct that there should be no
influence from ethical arguments to legal judgments, but I think
how the influence takes place and how the distinction is made is
something that is grappled with in the legal system all the time. 
I don't think we'd be creating a new problem, I guess is what I'm
saying, nor a problem that's been, for the most part, handled in
an unsatisfactory way in the cases that I'm familiar with where
there have been bodies like this that have made collective
ethical judgments that have been taken into account by legal
process at a later point.

          Ruth, would you -- does that sound --

          CHAIR FADEN:  No, I think that's a correct
characterization, and I would look at some of my colleagues.  I
think the issue that looms a little bit larger for this committee
is the fact that when we start talking about individual
culpability, then we are talking about named individuals in a way
in which, at least it's my recollection, was not the focus of the
other two commissions.  We can look to Jay when he joins us
later, certainly the Tuskegee Panel was somewhat differently
constituted with respect to needing to make judgments about the
named actors and actresses in that case involved in Tuskegee.  

          But, the national commission and the President's
Commission, my recollection looking over it was that the focus
there largely did not necessitate making judgments about
individual persons.

          DR. BUCHANAN:  I think there were implications, fairly
clear implications, about inappropriate conduct by particular
hospitals and by staff in particular hospitals, when statements
were made, for example, about how DNR policies are implemented or
not implemented.

          CHAIR FADEN:  That's right.

          DR. BUCHANAN:  But, there was not a -- you are right,
it was not a focus of either of those commissions' work to make
those kinds of judgments.  I think that's right.

          CHAIR FADEN:  A little bit different. I don't know that
it helps, but I think that my own sense is that we have to do
what we have to do, but mindful of the backdrop.

          I've got Henry wanting to speak, Duncan wanting to
speak.  Henry, then Duncan.  And, Phil, did you want to make a
comment as well?  No.  All right.  So, we've got Henry, and then
we'll return to your comments.  But, Henry?

          DR. ROYAL:  Allen, in general, I think accepting the
concept that someone is culpable if they subject another human
being to a risk without their knowledge, or expose them to a risk
that's unacceptable, I think that as a general principle I have
no difficulty with that.  So, I think as a policy that's fine.

          But, just as Wilson's policy was difficult to
implement, I think the problem that we're going to find with the
policy is that this policy is going to be difficult to implement,
and the difficulties are not only going to come from the evidence
problem, it also is going to come from the definitions.  You
know, you said, I think the words you said was, if someone
injected someone with a risky amount of plutonium, and I would
say to you, what is a risky amount of plutonium?  How many
micrograms can I inject in someone before it exceeds that level
of risky?  So, that's one aspect of the problem.

          The other aspect of the problem is going to be, what do
we mean by consent?  I personally don't believe that many people
who enroll in research projects today achieve this ideal of
informed consent.  I think that that's an ideal that we should
strive for, but I think in reality the understanding that
research participants have in research projects is not as good as
we would like it to be.  And, with the plutonium injections as an
example, what constitutes consent, how much did they have to
understand about it, how important was the word plutonium for
their understanding of what the risks were, what they were
agreeing to do, how important was the word radioactive in terms
of them understanding what the risks were, and whether or not
these should be acceptable risk.  I think that's when we're going
to have trouble.

          So, I think the policy, there's no problem with the
policy, that if you subject people to unacceptable risk that you
are culpable, but I'm interested to see whether we can implement
that policy.

          DR. BUCHANAN:  Those are both good points.  The point
about the ideal of informed consent and the point about what
counts as unacceptable risk.  The point about unacceptable risk,
I guess what I would like to remind the committee of is that this
isn't a new problem for the radiation cases.  I mean, the
Hippocratic tradition itself, with the fundamental tenet "do no
harm," obviously isn't understood literally, right, because
physicians do things which cause some harm to patients.  In many
instances, what's important is the idea of not producing net
harm, or of making sure that the balance of good over harm is
positive and significant.

          And, in the case of research, there's been a long
history, obviously, of trying to come to terms with what counts
as unacceptable risk.  But, in cases where there's no expected
therapeutic benefit, then clearly there are going to be some
cases where if there is reasonably expected risk of any
significant magnitude it raises very serious ethical problems,
because this is not something, you are not incurring a risk for
the sake of benefitting this patient, and if there's no consent
then clearly, even if there are borderline cases where it's not
clear that this is a significant amount of risk, there are going
to be many other cases where I think it would be reasonable to
say, well, if there was much risk at all that's too much risk,
given that there was no consent and no expected therapeutic
benefit.

          So, I think that though, you know, there are these grey
areas, we shouldn't concentrate just on the grey areas, because
if we did that in this case, in all consistency, we'd have to do
it in any other areas where we do make these judgments.  And, as
far as the ideal of informed consent goes, what's important is
that there be some minimal threshold of understanding to be
achieved, not that there be perfect knowledge.

          And, I think in the documents that Dan cited yesterday,
there were requirements of documentation, and that's something
that can be established in principle one way or the other. 
That's not a matter of how perfect the understanding is, or of
what full knowledge means.  That's a question of whether there
was some kind of documented assent, if not consent.

          DR. ROYAL:  Let me tell you what you and I agree on and
what we disagree on.

          DR. BUCHANAN:  Okay.

          DR. ROYAL:  We agree that consent is very important,
and I would -- we've got anyone who is culpable who enrolled a
patient in a research project, regardless of the risk, and did
not inform that patient or deceive them in any way.  So, I don't
even care about the risk in terms of the consent issue.

          But then, you went on to talk about this piece of paper
that is signed and in the file.  I could care less about that
piece of paper in terms of the ethics of the research experiment. 
It's nice for bureaucrats to be able to count pieces of paper,
but it doesn't seem to me that it has anything to do with whether
an experiment was conducted ethically or not.

          DR. BUCHANAN:  Well, except so far as a bureaucracy
imposes on itself an obligation to carry out its own policies.

          DR. ROYAL:  With the bureaucracy you might argue that
they failed to follow their policy, but I'm talking about the
investigator who --

          DR. BUCHANAN:  Oh, right, I think those are
distinguishable, and we're trying to distinguish between
judgments about physicians as medical professionals and judgments
about bureaucrats.  But, I take it that Dan's point is one that
we could all agree on, that if the bureaucracy, after
deliberation, imposes on itself a policy which makes a
requirement, say, of documentation of consent, then it's
appropriate to hold them to that standard.  And, if that's not
available, then quite apart from questions about how full the
informed consent should be or what the ideal is, there is a
ground for a judgment of culpability for the bureaucracy.

          And, if the medical professionals involved are supposed
to be carrying out the procedures according to the regulations
the bureaucracy establishes, and especially if they make no
effort to -- there's no evidence that they've protested this, or
made conscientious objection to it, then I don't see why the
medical professional couldn't be faulted for failing to comply
with the requirement of documentation.

          CHAIR FADEN:  Can I just sort of -- not a formal point
of order, but a point of clarifying the discussion?  We are now
slipping back and forth between the bureaucracy and
professionals.  And, in the interest of seeing whether we can
reach some clarification by sticking with one and then the other.

          Let me just, I know Duncan was waiting for a  turn as
it were, so if we have Duncan have his turn and then maybe we
could some focused amount of time talking about the bureaucracy,
and then some focused amount of time talking about the
profession, and then some focused amount of time.  If it turns
out that we concluded that there aren't that -- the differences
are not that significant, that's fine, but if we could sort of
try to do it a little systematically.

          Duncan, did you want to comment?

          DR. THOMAS:  Well, that last interchange between Henry
and Allen makes it, I think, all the clearer why it's important
that we try to develop some test cases.  It's just too easy,
speaking hypothetically, to say that there is or there isn't
evidence, or it's going to be very hard to develop evidence or
something like this.  I think we've just got to try.

          If we take what we think is maybe our best shot or one
of our best shots, and we work through it very, very carefully
and then as a committee at the end conclude that we're really,
even in this situation, don't have compelling evidence to find an
individual culpable, then I would be quite comfortable at that
point with saying, okay, well, let's restrict ourselves to
looking at organizational culpability, be it governmental or
professional.

          I think this is just an exercise we have to go through
at this point.

          CHAIR FADEN:  I think I would agree.  Is there anyone,
and let me just add this as an aside, that the TBI experiments
are on the agenda for later this afternoon for beginning that
process.

          DR. THOMAS:  That's a good step in that direction.  I
don't know exactly what's planned for this discussion this
afternoon, whether it will attempt to lay out the arguments for
finding these individuals culpable or not, or whether it's a
continuation of sort of the narrative general --

          CHAIR FADEN:  I think we can take it more in that
direction in the light of this discussion.

          DR. THOMAS:  Well, the question is whether staff is
adequately prepared to lead that argument, if they should find
individuals responsible.

          CHAIR FADEN:  I see.

          DR. THOMAS:  But, what I really wanted to say, though,
was picking up on one of Allen's earlier comments.  I've been
doing a lot of soul searching since my attempt to lead the charge
yesterday in which I made this sort of maybe there was an ill-
advised grand jury analogy of what we were about here, and it
seemed to go over like a lead balloon.  Phil Russell quarreled
with my judgment that we were just -- my assessment that our job
here was basically to bring the indictment, and that there would
be later appeals and appropriate due process, and there seemed to
be a general nods of heads at that time.

          And yet, I picked upon Allen's comment that what we are
trying to do is not reach a legal conclusion together with all
the associated legal sanctions that would go with it, but we're
trying to reach historical and ethical judgments, which are
somewhat different, and that the standards of evidence that are
required for a "conviction" in our court are maybe appropriately
different from those standards that might apply in a court of
law.

          I've gone back and forth on this so many times since I
uttered those words yesterday, I'm not sure what I think now, and
I would really like to invite Allen to extend his comments a
little bit further.

          MR. GUTTMAN:  Why don't you take a sample of where
you've been, Duncan, to arrive at it?

          DR. THOMAS:  Well, I'm deeply concerned about the
possibility of maligning somebody's character unfairly.  And, in
an environment where we report to the President and there is no
further upheaval behind that, right, whether or not some court of
law picks up the case and, you know, the prosecutor decides to
take this -- haul this guy into court, and he gets his day in
court then, clearly Charlie Wilson is not going to be called into
court at this point.  So, I'm particularly concerned, I guess,
about our historical -- attempting to set the historical record
right and doing it wrong.

          So, these are serious issues, and I'm not quite sure
what I believe at this point.  And, I still feel like we need to
go through the exercise.

          CHAIR FADEN:  Let me just jump in.  I think it's
critical.  I think that it would be a very grave error for the
committee to simply conclude in the general that we don't have
the evidentiary base, or we haven't thought, we can't think it
through well enough in the time frame that we've got.

          And, therefore, we are not --

          DR. THOMAS:  Without making the attempt.  I guess
that's --

          CHAIR FADEN:  Yes, without making the attempt, without
giving some concrete indication that we tried, and here is why
the 50 years time lapse fails us in being able to reach the sort
of judgments--

          DR. THOMAS:  I don't want to chicken out and just say
this looks like it's going to be too hard for us to do, so let's
not even try.

          DR. BUCHANAN:  I agree with that completely.  And, as
to your concern about not maligning people's character, I mean I
really feel that also, and one of the things that I tried to do
in both versions of the long paper was to put up some very clear
sign posts, and maybe they weren't forceful enough, which I think
should be erected in the final report, that there is a difference
between saying that someone's behavior in a particular instance
was morally defective and saying that they are bad people or
people of bad moral character.  I think that's extremely
important, and I think that the discussion in the paper of
mitigating factors addresses that, because in a different
climate, and this is something Mary Ann mentioned last night, in
a different climate, in the Cold War climate, within a certain
culture where there's close interlacing of military people and
medical people who were formally military people, it may be that
temptations are strong for people, good people to do things that
are wrong.          And, it's quite different to say that's what
happened than to say, oh, these people are scoundrels like the
Nazi experimenters.  And, I think it's very important to make
that distinction in order to avoid the error that you've alerted
us to of maligning people's character.  And, that will have to be
put very emphatically, I think, in the report, that distinction.

          CHAIR FADEN:  I see Ruth and Susan, then Mary Ann, and
I don't want to stifle the discussion, but let's see how this
goes.  Ruth.

          MS. MACKLIN:  My comment goes back to the exchange
between Henry and Allen, and also picks up on what sounded like a
procedural comment, Ruth, that you made about talking about the
obligations within a bureaucracy, talking about the ethics of
professions.  And, I'm not sure we can separate them so neatly
and distinctly.  I mean, one can analytically, as we discussed
yesterday about a profession, and then there was all this
mushiness about what the ethics of agents in a bureaucracy are,
and Allen has provided us with this helpful document, but I think
what Henry's and Allen's exchange showed is that contextually
members of a profession work in a bureaucratic setting.

          And so, the doctor who works in a hospital has the
obligations of a physician, but works in a bureaucratic
structure, so that when Henry says, I could care less about the
piece of paper, that's for, you know, bureaucratic -- granted,
speaking as a physician with the obligations of a physician, the
obligation of the physician in the informed consent process is
the process, communicating with the patient, trying to make sure
that the patient understands disclosing relevant information.

          What happens after that is a piece of paper for the
bureaucrats.  But, Allen is right to point out that if there are
rules for having those pieces of paper and making sure that they
are there and documentation of something, then there are
obligations that people within the bureaucratic setting have as
well, and one can say there is probably no better illustration in
today's practice of medicine than how doctors are caving in to
risk managers in hospitals.  Risk managers are bureaucrats who
have the hospital's interest at heart and not the patient's
interests at heart.  Whereas, the physician who ought to be
advocating for his or her patient in that setting very often
caves in, which I consider a piece of immoral behavior as a
professional.

          So, taking just another example, I mean I'm using that
as one example, that's one of my pet peeves, but taking the
example from something Allen says here and then asking, what are
the obligations of a physician in the military, you've got a
person who is a member of the medical profession, who is also in
the military and has bureaucratic obligations.  

          Now, Allen's point on the first page here, the
principle of common sense morality also reflected in the law,
including military law, says so far as military personnel may
refuse an order that requires a clear and gross immorality.  So,
in other words, whatever your obligations are to obey orders in
the military, it does not include obeying grossly immoral orders.

          However, what if you have a physician in the military
whose obligation is to obey orders or follow orders of his or her
superior, and yet, the order is not one of these gross
immoralities, but something that within the context of the
practice of medicine would be unethical if done in a doctor's
office, but here you have military concerns, et cetera.  Now, my
point is only here an analytic one, to say contextually we may
not be able clearly to separate the obligations of professionals
and those of a bureaucratic, a bureaucracy.

          If we think of doctors working in their private offices
and encountering in a doctor/patient encounter, fine, we can talk
about the profession, but the lines are likely to be blurred and,
therefore, it may be difficult for us, even though we can make
the general account or acknowledge some of the general points
that Allen makes here and draw on our general knowledge of the
obligations of people in professions, or of professionals, we
have to look at I think in the context.

          DR. BUCHANAN:  Ruth, could I just make one friendly
amendment to that.  I think those points are well taken.  I think
there is a sense within the traditions of medical ethics that
where there are these conflicts between, roughly, bureaucratic
obligations and the primary obligation to serve and protect the
interests of the patient, that it's the latter that should take
precedent.

          In fact, one of the criticisms of the Nazi doctors was
that they became instruments of the state bureaucracy to the
detriment of the people they were working on or working with or
on.

          And, I think that was also one of the chief criticisms
of Soviet medicine, of the Soviet medical establishment,
especially the psychiatric establishment, that doctors became
instruments of the bureaucracy, became tools of the state to the
detriment of the people whose interests they should have been
serving and protecting.

          So, it's true that, you know, from a human and
individual standpoint there are tremendous pressures and a
pulling in different directions on physicians who find themselves
within the context of a bureaucratic organization.

          But, I think there is a fairly strong tradition in
medical ethics which says that the primary obligation of a
physician is to serve and protect the interests of the patient
and not to become a tool of bureaucratic policy, if that works to
the detriment of the patient.  

          That's just a reminder.

          MS. MACKLIN:  Yes, I entirely agree with that analysis. 
I mean, there are a hierarchy of obligations, and the obligation
of physicians or professionals in this case, medical
professionals, the patients should come above it, so that we can,
in our going back to our ideal world, construct a hierarchy of
obligations and say which comes first.

          But, as your analysis of whistle blowing here also
points out, and probably needs no reminder to anyone, people in
any kind of real life setting have their self-interests as well,
so it's not just --

          DR. BUCHANAN:  And, it's legitimate.

          MS. MACKLIN:  -- the obligation to the state or to the
bureaucracy, the obligation to the patient and the obligation to
the patient standing above it.  Being in a bureaucracy, your
self-interest, and not your selfish self-interest, but your self-
interest may be very much influenced by the extent to which you
defy or ignore what the bureaucracy says.

          Now, that's not to -- I mean, it may be hard to be
ethical sometimes, but I would entirely agree with the hierarchy
of obligations, but only point out that again in the context of
people may not be cited for being clearly immoral if they take
into account their self-interest in terms of their livelihood in
a bureaucratic setting.

          CHAIR FADEN:  Just so I -- I just want to make sure
that I've got everybody acknowledged, Susan, Mary Ann, Henry and
Bill, unless somebody wants to speak right on this point, I'm
going to go in that order.  Did you want to come in on this
point?

          DR. ROYAL:  Yes.  I just wanted to make sure that my
comments on pieces of paper weren't misunderstood.

          I think pieces of paper are extremely important for
accountability, achieving accountability, but in terms of
deciding whether or not informed consent was obtained or not,
having the piece of paper, and I guess particularly not having
the piece of paper 40 years after the event doesn't seem to me to
weigh very much one way or the other about whether informed
consent was obtained or consent was obtained.

          CHAIR FADEN:  I agree.

          Phil, you had something right on this?

          DR. RUSSELL:  Yes, related to both of those issues. 
The Army Medical Department, of course, struggled with these
issues for many, many years, and as a result the conflicts came
and some of the difficulties came when medical officers were
working under the command of non-medical organizations such as
the Chemical Corps.

          A solution that has gradually come into being, is
virtually all the medical officers work under a medical command,
and at the top of that medical command is the surgeon general. 
So that, there are virtually very few, if any, medical officers
whose commander is not also a medical officer, and the surgeon
general being one of the major exceptions, his commander, of
course, is the Chief of Staff.  But, this issue of the conflict
between the interest of the patients, the interest of the patient
care system versus the interest of the other parts of the Army,
has been a problem for decades, probably since there were armies.

          It's been my experience as a bureaucrat with a lot of
experience with investigations that the last refuge of a failed
or incompetent investigation is to bitch about the paper work. 
When they can't find anything wrong with the outcome, when they
can't find anything wrong with what people did, they complain
that you didn't have all the records correct.  I think that's
enough on that subject.

          CHAIR FADEN:  Important observation.

          Susan.

          DR. LEDERER:  I guess I want to return for a moment to
a point that I think was made earlier by Duncan, and wanted to
ask you, Allen, to what extent do you think that the exercise of
retrospective moral judgment and particularly assignment or
identification of individual culpability will impede or interfere
with our obligation to do the historical work, that is, to tell
the story which I understand is also a part of our charge.

          DR. BUCHANAN:  Yes.  Well, as you know I think, this is
a crucial issue, and though I believe that it's required by the
committee's charge not just to tell a story but to make
judgments, ethical judgments, I think it's extremely important as
to how that's done and to make sure that there's a kind of
signaling in the text as to which hat the authors are wearing at
the time.

          It's going to be important to have narratives which
present the facts, and then sort of give a signal of switching
gears to making evaluations on the basis of an understanding of
the facts as presented in the narrative.  And, this can partly be
done as a matter of actual layout in the text with, you know,
evaluations as a separate section or whatever, but I think there
is a danger of mixing the two together in ways that aren't made
clear to the reader, mixing together the evaluation and the
reporting of the facts.

          Now, obviously, values determine to some extent which
facts are selected, and we all know this story that there's no
such thing as completely value neutral historical research, but,
nonetheless, one can make serious efforts to try to minimize the
problem of confusing the two and I think that's really important. 
I think it can hardly be overemphasized.

          CHAIR FADEN:  Mary Ann.

          DR. STEVENSON:  It seems that the discussion thus far
has centered on the availability or credibility of evidence that
we may or may not come up with, and that will guide our ability
to make judgments, as Allen and I were discussing last night.

          At least I'd like to see before we move on to
discussions of a test case or the TBI, some more discussion on
this concept of mitigating factors, and myself would like to get
a sense of how we are going to weigh those in to our decision
making and judgments, because I think there are going to be cases
where the evidence is quite clear, I mean, that something was
done.  There's going to be no doubt that there were plutonium
injections, and there were certain individuals that were clearly
involved in those.  The same with the TBI.

          And, for my own peace of mind, I want to get a sense
and see some discussion of how mitigating factors play into our
making of judgments, or whether or not we think they should at
all, because I think the spectrum of judgment may span, some
people may think there are no mitigating factors.  I think we
have to come to some consensus about that before we move on to a
test case.

          I think the categories of mitigating factors will be
easier in some cases and harder in others.  They'll be as you've
presented in your paper factual ignorance, which might be taken
as dosimetry that was incorrect, done in good faith with the
facts available, which I think is easier to deal with than moral
ignorance, which is, you know, sort of very much couched in what
was going on at the time and attitudes, Cold War panic.

          I don't know myself how to factor those things in, so
I'd just like to see more discussion and get some of your
opinions.

          DR. BUCHANAN:  Yes.  I think this is right on target. 
I think we've tended to at least give the impression in the
discussion of the last couple of days that the evidentiary
issues, the only issue that affects determinations of
culpability, whether of organizations or individuals or
professions, and as you point out, there's also the question of
mitigating factors.

          I mean, you might conclude that wrong things were done,
and even that some individuals were wronged, but then stop short
of making judgments of culpability on the grounds that there were
mitigating factors.

          And, I think in the eyes of the general public, and
certainly what you see in the press, there is a fairly pervasive
idea that there was a big mitigating factor, namely, the context
of whatever you want to call it, Cold War hysteria, or maybe at
the time it wasn't hysteria, maybe it was appropriate given the
unpredictability of the situation and how high the stakes were. 
That has to be addressed, I think very clearly, and I think it's
difficult to address it.

          I talk in the long paper about how there are a number
of factors that can be mitigating factors.  As you mentioned,
factual ignorance, and then you have to ask whether it's culpable
or non-culpable factual ignorance, moral ignorance, whether it's
culpable or non-culpable, and also there's this problem of the
evolution of moral standards, and the fact that the evolution is
not one of discreet steps where, you know, on day one we had a
very minimal conception of consent, and then on day two all of a
sudden we had the full blown rich notion of informed consent. 
Instead, there's a shift, just as there's a shift in the example
that I gave in the awareness of what sexism is, or what racism
is, and consequently a shift in the standards of culpability
which are appropriate to apply to individuals at different times. 

          That just has to be done, as Duncan said, in the light
of concrete cases, where we can make those theoretical
distinctions lively and vivid.  

          But, there is one parameter, I guess, that has to be
kept in mind when looking at mitigating factors, especially if
you think of national security interests or Cold War concerns as
a general kind of context which could be invoked as a mitigation,
and that is, it was made clear at Nuremberg, and it's essential
also to the doctrine of human rights in its most common
understanding, that there are some obligations which we have in
our behavior toward other human beings which cannot be overridden
simply by appeal to national security.  I mean, that was the
message of Nuremberg, okay, because the way the Nazi doctors at
least alleged their view of what they were doing was, was that
they were acting in the national interests of Germany and that
that justified them doing things which otherwise would have been
inappropriate to do according to standard canons of morality and
medical ethics.

          And, similarly, it's essential to the idea of human
rights, as it is understood in world theory and in international
law, that it's not a sufficient justification for violating human
right to say that doing so is necessary for the national
interest.  I mean, that's the whole point in a sense of saying
that these are such fundamental moral requirements that they have
the status of human rights, because otherwise every government
will attempt to invoke national security or emergency conditions
as grounds for overturning these rights.

          So, that's a parameter that has to be kept in mind. 
Now, that certainly doesn't answer all the questions, and I
happen to think that probably the most difficult moral issues
have to do with when it's appropriate to make some relaxation of
moral standards, not an overturning of them, but some relaxation
of them, in the light of sincere beliefs about, you know, peril
to the national interest, emergency situations.

          We really haven't talked about that much, and I think
unless it is addressed pretty squarely by the committee, a lot of
people are going to say, wait a minute, you missed the point.

          So, yes, I'd be happy to hear what anybody has to say
about that, because I don't know what to say about it.

          MR. GUTTMAN:  I want to make a factual observation
here.  We had this discussion right at the beginning, Jeff Kahn
and I, in particular, discussed this at great length, and that
seems like years ago, many months ago, and two points.  One is
that what's-- one of the things that's most remarkable,
obviously, is that the Secretary, Secretary Wilson's Nuremberg
Code was expressly in the middle of the Korean context and
addressing -- it's sort of punctuating Allen's point, not only
that the code that was applied to the Germans applied in clear
recognition of whether there was a war going on, but our
Secretary of Defense issued a code in the context of the war
going on.

          So, the point I want to make, I raise this not as an
assertion of fact, but as a challenge, I don't know from the
facts we've seen of any situation where anybody said, well, this
would be the -- normally, we do it this way, but because of
national security we are not going to do consent.

          Now, there are other things going on, and I don't want
to get into the TBI, but, for example, in the Cincinnati case,
nobody said, well, normally we'd have consent, but because of
national security reasons we don't.  So that, I don't think, Mary
Ann's point, your point is obviously, what is mitigation is a
critical situation, but what I want to throw out on the table is,
I don't see as a fact pattern that national security, the thing
that the press and everybody says, well, that's the thing that's
going to be the big mitigating circumstance, I'm not sure we have
that here.  That's an irony and would be a very interesting
finding.

          DR. RUSSELL:  What about the fact that a lot of these
experiments were classified?  Does that, on the face of it,
indicate that there was a national security concern?

          MR. GUTTMAN:  No, no, they weren't, that's the
interesting -- this is the very -- yes, there's a clear break
here in, of course, the Manhattan project, plutonium, those up to
1947 they worked, but then what happens precisely is that Shields
Warren, our friend, in the context of the need by debate, says if
we are going to do anything that's got to do with military, we've
got to, you know, whether it's for moral reasons or public
relations reasons, who knows, or all 17 of them, we've got to
have it out in the open.  And, to my mind, that's why the
Cincinnati thing and the M.D. Anderson, and that's why it was
done out in the open.

          Now, the bomb test things are a whole separate kettle
which we'll get into, but all I'm saying is, we want to talk
about the laboratory, the biomedical, the Cincinnati, it's not
obvious that you could make a case that things that would govern
in normal moral settings would be waived for national security
reasons, for other reasons, all other kinds of things maybe.

          DR. BUCHANAN:  Right, but also, hasn't the committee,
in the last month or two, uncovered some evidence to indicate
that it's just a mistake to assume that because something was
classified it was classified because of national security
reasons?  Instead, there is some indication that things were
classified to avoid legal liability and public outrage.

          MR. GUTTMAN:  Let's put that -- I don't want to
complicate it, I just want to make it simple.

          DR. BUCHANAN:  It's a separate point.

          MR. GUTTMAN:  Right, the simple point, and this is not
an assertion of what -- someone would have to come forward with a
case where somebody said, well, consent would normally apply, but
here, then you'd have a chain of command issue because then,
clearly, with national security, I don't know if we've thought
about it, I'm just giving -- would it be enough for doctor so and
so at Harvard to say, well, Cold War national security, or would
that have to be something that's raised by, if not the General,
the Secretary of Defense?  I mean, who has the right to assert
the national security trump card?

          And, I guess what I'm saying is, on the facts that
we've seen we haven't seen that asserted.  It's been fuzzed. 
What you really have is more of in the bomb test setting, let's
not call it an experiment, it's occupational, the AEC saying,
gee, this is a touchy political situation, let's let the Defense
Department take charge and they'll call it occupational.  And,
it's sort of, in some ways, a much more subtle way of permitting
national security to rule.

          But, in the biomedical laboratory settings, the ones
that we are going to cover, I don't think we find, in Ruth's
words, national security being used as a trump card.

          DR. STEVENSON:  Well, except for in the dual purpose
experiments, where the experiments are being conducted under one
guise and, perhaps, under consent for one guise, and the second
purpose is not really being revealed or necessarily consent being
given for it.

          CHAIR FADEN:  I think that this is why it probably is
going to be the most helpful to do this to some extent in the
context of talking about either the TBI experiments or some of
the bomb test related experiences, which some were clearly called
experiments and some were not.  But, if we take it in the really
starkly articulated sense of a formal appeal to national
security, we are going to waive the Wilson memo in this case
because of national security reasons.  That would be a start. 
The Wilson memo is signed in '53, and then in '54 there are a
series of experiments, and somebody up high or down low calls it
saying, we know the Wilson memo is here, but we are not going to
adhere to the Wilson memo because we've got a national security
override.  We have nothing, that never happened.  Okay.

          And, I think it really does need to be punctuated, as
Dan points out, that it's in the midst of the Korean everything,
the whole height of the Cold War stuff, in the beginning, not
quite to the Bay of Pigs, but we are getting, we are marching our
way up there, that the Wilson memo is signed in the agency that's
most concerned arguably, with defending the national defense,
defending -- looking out for the defense of the nation.

          So, we can't -- we don't have this like stark case.

          Now, the warriors are problematic, and the plutonium
experiments conducted during the war, the classification issues
there are linked to a national-- clearly linked to a national
security interest with respect to not telling the world how far
we are getting in the development of plutonium and a capacity to
explode an atomic bomb.  So, that's got to be marked off as Dan
points out.

          But, even the plutonium experiments immediately after
the war, the policies changed.  The few injections that occur
afterwards, interestingly enough, there's a shift in the way in
which they are done.  So, we have to think, you know, all the way
through, but we don't -- so, it is, I think as you say, very
important to point out that we started out with this hypothesis
that national security appeals were going to loom formally large. 
They don't loom formally large, but they do in the way Mary Ann
suggested seem to permeate how people were thinking about what
they were doing and the secrecy issues and the kind of shading
what we are doing, describing it somewhat differently, all that
kind of stuff, it's all more subtle.

          MR. GUTTMAN:  To put a positive spin on it in terms of
the message, one of the terrifically important findings, a
rewriting of what might be called the historical era or something
like that, is in this country nobody said, oh, national security,
in the narrow context we are looking at people didn't routinely
say national security can override human rights.  They recognized
that was a principle, the individual rights had to be governed.

          Now, how human rights got ignored, that's a much more
complex subtle question, but the good news is that nobody said,
oh, just invoke national security and just do this.

          Ruth points, I mean, she is amazed with the prisoners,
isn't that right --

          CHAIR FADEN:  Yes.

          MR. GUTTMAN:  -- in World War II.

          CHAIR FADEN:  I have to say that it's, to me, I
actually had some conversations with Jay and with Susan and John
and others, I keep coming back to, I find it quite remarkable,
and trying to figure out the significance of the fact that during
the war the-- what was the medical committee called -- Committee
on Medical Research, the CMR, insisted repeatedly that instead
prisoners had to be volunteers and that consent forms had to be
signed.

          Now, I'm not making any claims about the meaningfulness
or the significance of the kinds of consents that were actually
solicited and the conditions, and whether they could, in fact,
truly be volunteers, and all of that very important substantive
stuff.  But, at a time when this -- in a time in which we felt it
justified as a nation to conscript young men and send them into
battle in order to defend the nation, and the reason these
experiments with prisoners were done, were also, obviously, as
Phil can well describe, expressly in order to improve the
capacity of the men fighting to fight effectively, to be
protected from diseases.  This was vaccine research, Phil,
largely, and other kinds of work.  There was no view then that we
could conscript the prisoners and inject them with live viral
agents or with new vaccines, that that had to be -- at least on
paper there was this view, and it's repeatedly stated.

          Now, what that says is what I'm struggling with, what
is that -- what was the thinking behind it, quite apart from the
practice of it, but what did it express?  Why was it there?  Was
it simply because they were worried about getting sued, or was it
because they had some sense that this was crossing the line?  I
don't know.

          DR. BUCHANAN:  Well, I suspect that it wasn't just for
reasons of liability.  I mean, I really think that, you know, one
difference between sort of our side and the people we were
fighting in World War II was that the other people, the other
side was quite willing to say, and explicitly said, that
individual rights can be overridden by considerations of the
state, of the collective.

          And, I think it's, you know, part of what defines our
identity as a political culture that we say no, there is such a
thing as some basic set of rights which can't be overridden, even
for the sake of national security, or the common good, or
whatever.

          CHAIR FADEN:  What would be nice, and then I know Phil
and Jay want to say something, what would be nice is if that's
correct, I mean, one side of me thinks that it's an explanation
of that order, the other side is, it was a kind of public
relations or legal convenience, that, in fact, the conditions in
the prisons were such that they essentially were impressed into
this.  I mean, I just don't know.

          DR. BUCHANAN:  See, I'm not sure that you can
distinguish those things as clearly as you are suggesting.

          CHAIR FADEN:  Perhaps, you can't, perhaps, the
motivations are all mixed.

          DR. BUCHANAN:  I think that when it comes to questions
of what I call moral identity, there are a number of reasons why
people will espouse certain principles.  And, in some ways,
though, they may be motivated partly by fairly venal
considerations to espouse them, the public act of declaring them
is itself a kind of expression of the values, and you can't
separate it entirely from --

          CHAIR FADEN:  No, I agree, I agree, and I know I should
stop talking.  Susan has been waiting patiently, and Phil and Jay
have signaled.

          DR. LEDERER:  Well, just to follow up on Ruth's point,
that during the 2nd World War conscientious objectors, too, were
also participating in a very formalized consent process.

          CHAIR FADEN:  That's right.

          DR. LEDERER:  And, even prior review.

          I guess a puzzle that I have in all this and what to
make of it is the decision not to prosecute the Japanese medical
experimenters, in the way that the German medical experimenters
were prosecuted, in the name of national security.

          MR. GUTTMAN:  We know that, there's a book out on this
now.

          DR. LEDERER:  I know, but what are we to make of it. 
This is really a question for Dan, to some extent, who just left
the table.

          MR. GUTTMAN:  Well, we know, Jay has said you all
should read this, a professor in California has written this very
-- actually, what I know about it is from Jon Harkness, but we've
actually -- the CIA has got some documents we are trying to
spring loose on this, but Jay can talk about it.  We've been
trying to get some more information.

          CHAIR FADEN:  Phil, and then Jay.

          DR. RUSSELL:  I think that during World War II there
was a tremendous spirit of volunteerism throughout the country
for all sorts of things, and within the Armed Services the higher
risk duties were frequently volunteer duties, the elite units and
aircraft pilots and so forth, these were all volunteers.  Of
course, the front line infantry men, who had the most dangerous
job, wasn't, but, nonetheless, there was a tremendous spirit of
volunteerism, and there was a concept that the prisoners should
be allowed to volunteer, that this was something that would maybe
offer them some redemption.  I think that thinking was embedded
in this.

          CHAIR FADEN:  Right, this is a way they could serve the
nation.

          DR. RUSSELL:  The same way with the conscientious
objectors, there was a way they could serve and be volunteers,
even though they couldn't participate in combat.

          CHAIR FADEN:  I think that comes out, you know, fairly
clear, I think even more with the conscientious objectors
program.  The notion is still that they had to be -- therefore,
you refused to be drafted, therefore, we're drafting you into a
medical experiment pool.

          DR. LEDERER:  And, interestingly, I think in the case
of conscientious objectors, there were some experiments I guess
that were deemed too dangerous for them to participate.  I mean,
so there's some concern about their well-being, as well as their
ability to volunteer.

          CHAIR FADEN:  Jay and Lois.

          DR. KATZ:  Well, you know, in all this what I've just
heard, you know, there are puzzles, not so much puzzles within
puzzles, but games within games.  If you look at the Japanese,
our Japanese experiment, in my reading of Sheldon's book it
becomes quite clear, or seems quite clear, that, first of all,
there are always a few individuals involved, and I'm not even
sure whether the primary person --  I think the primary person
involved was an American physician who was very much interested
in obtaining the Japanese data, thought it was very important. 
And, he had a major role to play in convincing MacArthur's
headquarters that a deal be struck that the Japanese physicians
and researchers be given in unity so that we could get hold of
these secret documents, because furthering our understanding of
biological warfare topped almost everything else.

          This was, in part, true also for some of the
negotiations that were entered into with the German scientists,
there is information available, but it's very hard to get a hold
of that information as yet.  I've been trying with some of my
German sources to see whether I can unearth something.

          But then, you know, with respect to the whole issue of
implication of national security, what law allows and doesn't
allow one to do, I'm very sensitive to this because when I left
the medical school to live at the law school, I suddenly, over
the years, became aware that law doesn't really require you to do
all kinds of things, that things are not -- national security
doesn't mean what I imagined it meant to me with respect to
obligation, with respect to this thing and the other thing, that
when a lawyer now tells me the law requires you to testify to
this, that and the other thing, I say, no, that's you talking,
the law doesn't require me to do that at all.

          The point I'm trying to make, also in appreciation of
what the medical people were struggling with, that we have to say
something about it, not to exculpate them, but to put it all in
context, that they were also reacting to what they thought was
certain legal national requirements, and nobody disabused them,
you know, that they really had choices, that national security
does not necessarily require them to go gungho with respect to
this, that and the other kind of research.  And, of course, all
this was embedded that they didn't have the strong -- real strong
feeling for professional code of research ethics of their own, so
that's what I mean, you know, there are games within games that
we have to -- if you are legal minded, we have to write about,
but write about it and say that ignorance of the law does not
excuse you from being blamed for things that you have done.

          CHAIR FADEN:  Lois.

          MS. NORRIS:  Just a factual question about
conscientious objectors, and I'll just get it during the break,
it's really not germane to the conversation at this point.  I'll
get it from someone.

          CHAIR FADEN:  Susan would probably be your best source
on answering that.

          We're at the time that we had scheduled for break, and
I'm thinking maybe that it's not a bad idea.  I know people need
to check out of their hotel rooms, and we'll caucus a little bit
about what to do after the break.  But, let's take a 15-minute
break, is that enough time for people to check out and come back
and bring your coffee, the food is already at the table.

          (Whereupon, at 10:15 a.m., a recess until 10:42 a.m.)

          CHAIR FADEN:  Here's what we are going to try to do
with the morning.  We are going to continue the discussion with
Allen for about a half hour.  Eli wanted to pick up where Jay had
left off, and we will do that, but we want to take at least a
part of that half hour to focus specifically on the document that
Allen prepared for us last night.

          I don't want to spend more than a half hour on this,
though, although we could clearly go on forever, because we do
want to get to some of the other things on the agenda.

          We'll then have the presentation on the contemporary
agency oversight work that's being done by staff, and,
Wilhelmine, we'll do that before lunch.  Wilhelmine will give us
the presentation before lunch, roughly, let's say from 11:15 to
12:15.  So, we'll have the discussion from now until 11:15,
switch gears, have the presentation on what we have done learned
thus far about contemporary agency oversight for roughly an hour,
break at lunch -- break at 12:15 for lunch.

          And, here's what I would like to suggest that we do
after lunch, in the time allotted for TBI.  Clearly, I think
there's agreement that we need to press to see how far it is
possible in a few test cases for us to go with respect to making
judgments about individual culpability of either people in
bureaucratic roles, people in roles of physician investigators,
or in some combination, people in combined roles.  

          And, what I think would be profitable would be for us
to be thinking over lunch the kinds of information we feel each
of us we would need to make such judgments about people involved
in the TBI experiments, including people involved as bureaucrats
in the oversight of the funding of the TBI research through to
the physician investigators at the various institutions, who
actually conducted the research.

          Rather than ask the staff to present the best case for
holding somebody blameworthy or not holding somebody blameworthy,
we will ask the staff, they'll be both Gary Stern and Ron Neumann
who are our most knowledgeable staff members on the TBI
situation, will be at the table, we will ask them our questions,
and we'll see what kinds of answers staff has to them, and then
we can get -- we can do that as a move towards seeing how close
are we to having the kind of information that we think we need,
and if we are missing pieces of information Ron and Gary can give
their best guesses as to whether it would ever be possible to get
that information or reasonably possible to get that information
in the course of the life of this committee, given our resources.

          So, if that's agreeable to everybody, we'll start the
process.  We'll see how far our fact finding and our evidentiary
base is in this area, as one case example, and if we decide to do
-- either continue with that one at the next meeting or start
with another one, another kind of case example, we can do that in
February.  But, it's an effort on our part to see whether we have
in this setting the evidentiary base to make any judgments about
anybody other than the funding institution.

          So, is that agreeable with everyone?  And, we'll try to
do it both for the bureaucrats, however we define them, the
people who gave the money on the part of the Department of
Defense to the various institutions involved in TBI research, as
well as the investigators and the university officials who
received the money and so on, but see how far we can get.

          So, if we could be thinking during lunch about the
kinds of questions that we would like -- kinds of information we
think we would need to have, so that you have them formed in the
way of questions, Ron and Gary will start with a very brief
update of new information that we now have since the last time
we've had a committee discussion about the TBI experiments, but
after that it will be our asking staff questions, so be prepared,
you know, with your questions.

          Before we do our half hour further on developing our
understanding of the issues of making judgments about
culpability, Reed, do you want to make an announcement?

          DR. TUCKSON:  I do, but it turns out Henry is not back
yet, and so --

          CHAIR FADEN:  All right, then I will make -- I will ask
you to make the announcement when we come back from lunch?

          DR. TUCKSON:  Thank you, ma'am.

          CHAIR FADEN:  Okay, if I remember.

          DR. TUCKSON:  I will.

          CHAIR FADEN:  Thank you.

          Okay.  We are going -- we want to focus on the memo
Allen prepared, but, Eli, you wanted to pick up or have comment,
and so why don't we start with that.

          DR. GLATSTEIN:  I just wanted to emphasize the point
that I think is really very important that Jay touched on, and
that is that at the professional level there really was no
codified structure with respect to the ethics of scientific
investigation for physicians.

          Now, the reason why I think this is important is that
the whole idea of the communication process between the doctor
and the patient has undergone a revolution in my lifetime, in my
professional lifetime.  In the early '60s, it was not uncommon at
all not to tell a patient a diagnosis of cancer.  It simply
wasn't done.  I can remember being shocked to find that there was
a journal called Cancer, that people actually talked about it and
wrote about it, but it wasn't done.

          Now today in this country, not only is it done, you
have to get a consent form to do almost anything, and that's
important because there are plenty of Western countries where you
don't have to have a consent form today.  Our standards have
changed enormously, and it's an evolutionary process, it's not an
abrupt one.

          And, I think it's important to realize this in terms of
the medical side of the investigation.  Now, I hate to sound like
a broken record because I've said this before, but I think there
really are two components to what we are trying to do here.  One
is medical research investigation, in terms of the administration
of radiation, but the other is, essentially, population exposure,
largely through the military and other non-medical agencies of
the federal government.  And, I don't think these two things are
the same at all.

          I think you get a clue of that from the absence of
long-term interest in the people who are exposed in the military
in particular, I think the presentation this morning from Mr.
McKay is particularly cogent.

          The military's interest in this was obviously short
term, will a unit function following a radiation exposure, and
then another era, I can remember news reels, which you don't see
today in the movies, but in those days they would show the atomic
blasts, you didn't have TV at home, and I can remember distinctly
seeing these atomic blasts, and I was young enough at the time
not to know much, but I knew radiation was dangerous because you
used to be able to use x-ray units to look at your feet when you
were getting shoes.  That was a little episode that lasted a year
or so before they were quickly taken off the market, because it
was recognized that they were dangerous, that you could get
cancer from it.  It didn't last very long, maybe it was two
years, but it wasn't very long, that's all I remember, but I
remember I used to watch my feet.

          But, that vanished very quickly because it was
understood that at some level that that was dangerous, and yet,
they were doing -- exposing the troops to radiation and one has
to wonder, even at a young age, what is the long-term risk? 

          Well, obviously, the military weren't interested in the
long-term risk, their interest was short term. I mean, that's the
reality of the situation.  That's why no one has been monitoring
these people in the first place.

          And, I just want to emphasize the point that it's very
hard for us to make these judgments today in the light of what we
think is standard, when the standards of another era were
drastically different and highly variable depending on who you
are dealing with.

          CHAIR FADEN:  Eli, I think you are right to remind us
that we have a mandate in these other -- with respect to
intentional releases and in this other context, and just so
everybody knows, that's a chunk of what we will be doing in
February.  We'll have some more discussion about that tomorrow, I
mean this afternoon, that it is right that we need to make sure
that our analysis of these questions of culpability extends to
what may turn out to require -- a context that may require a
different kind of set of considerations.  We are going to do
that, as I understand it, looking at people on that subcommittee
in February.

          Shall we try and spend 15 minutes or so further, 20
minutes, focusing on Allen's memo, being mindful of Ruth's
comment, that sharp minds between the bureaucracy and the
professional are not always capable of being maintained.

          DR. BUCHANAN:  Just a couple of prefatory remarks. 
First of all, please remember this was whipped together in the
late hours last night and early this morning, so I'm sure it can
be improved on enormously, and I'm looking for guidance on that. 
It's really just to stimulate discussion.

          Secondly, I think this is an appropriate point to raise
a question for the committee.  As I was thinking about ethics of
bureaucratic organizations, obviously, I was thinking in terms of
military organizations, government organizations, involved in the
human radiation experiments, but there's another kind of
organization, often heavily bureaucratized, which played some
role in some of the experiments, and that is business
organizations.  The suppliers of isotopes, the Quaker Oatmeal
Company that laced the oatmeal at Fernald, and also various kinds
of laboratories that were licensed and to which work was
contracted out, and I think that given that the focus of the
committee has already been directed toward a fairly wide area,
including medical profession, medical organizations, military,
government, that it's worth asking whether there should be
something in the report that addresses the question of the role
of the private sector in this.  

          And, one of the reasons is forward looking, I think
there are going to be inevitable comparisons made in the general
public and in the press, and even in the scholarly literature,
between the experience of the radiation experiments and what we
are embarking on now in genetic technology, the human genome
project.  There are parallels that Ruth Faden has pointed out to
me, there's the promise of something great coming from science,
but there's the danger of a dark side in both of these cases.

          And, in the human genome project, and everything that's
coming out of it, there's tremendous involvement by business, and
so it's a mistake to act as if the only players in ethically
sensitive areas are medical professionals, scientists and
government.  Instead, there's this huge involvement by the
private sector, and I think it would be a good question to ask
for the committee to ask at some point, what was the role of
private business in this, were there shared ethical
responsibilities involved in actors from the private sector in
all of this?  So, that's just an aside.  The thought was
triggered in my mind mainly by just thinking about bureaucratic
organizations and problems of imputing responsibility within
them, and that's obviously a problem in businesses, in large
corporate structures, as it is in military and governmental
structures.

          Now, what I've tried to do in this little handout is
not to make judgments about whether there were violations of
ethical responsibilities in particular organizations involved in
the radiation experiments, but simply to try to lay out a kind of
general framework that will facilitate the committee's thinking
about those kinds of judgments.  So, I've just tried to say
something about what the concept of role-defined ethical
obligations is, and the second item, this idea that even though
one has obligations by virtue of one's role, that doesn't put an
end to moral questions and questions of moral responsibility, and
then third I've tried to articulate on III what some of the most
salient obligations are of superiors on the one hand, or
managers, or whatever you want to call it, people in executive
positions, people high in the hierarchy, and obligations of
people who are subordinates.  And, that's, of course, with a
caveat that in most cases a person will be a subordinate of
someone and a superior of someone else, okay, so you have
obligations facing in both directions, and there can be conflicts
among them.

          And, I think that this attempt to set out what the
obligations in bureaucratic organizations are will be helpful,
not just for asking in the light of the data whether we can make
judgments of individual or organizational culpability, but also
for the forward looking task of the committee in making
recommendations about how to avoid problems within organizations
in the future, where there is use of human subjects.

          And, the main points, I try to summarize the main
points in this little summary at the end, and I guess one the
chief ideas which may be controversial is that there is an
obligation, especially on the part of leaders of organizations,
to try to create what I call conditions of accountability, that
is, to create a structure in which duties are clearly defined,
and in which it is possible to make well-grounded judgments of
praise and blame, and to make distinctions between individual
culpability and collective culpability.

          Anyway, that's the rough shot, it's very rough, so have
a go at it.

          CHAIR FADEN:  I saw Henry's.

          DR. ROYAL:  You offended one of my sensitives, but --

          DR. BUCHANAN:  Only one?

          DR. ROYAL:  -- I have to react to it.  Here we are
trying to carefully and defensively consider how we can make
ethical judgments, and it seems to me that a crucial part of that
process is not to unnecessarily use inflammatory language.  And,
when you referred to the Quaker Oats Company, you said that the
oatmeal was laced with radioactive material or radio isotopes.  I
just don't think that that kind of language is going to help us
at all.

          DR. BUCHANAN:  I agree, and it certainly wasn't
something that I would have put in a written document.  It was
off-hand comment.  I think the point is well taken.

          DR. KATZ:  How should we put it?

          DR. BUCHANAN:  Flavored?

          DR. ROYAL:  I think that there are many more neutral
words than saying that something was laced with radionuclide,
poisoned with a radionuclide, if, in fact, that's what you
believe, that we fed -- see, the reason I think it's so bad is
that, instead of allowing us to focus on the real ethical issues,
the Quaker Oats thing for example, which is taking advantage of a
vulnerable population, we get distracted by this -- all these
irrelevant ethical issues, and you shouldn't distract us from the
fundamental ethical issue which in the particular case of the
oatmeal is that this was a vulnerable population, unless you want
to make an ethical argument that the risk due to tracer
experiments is unacceptable.

          I haven't heard anyone making that argument.  I'm
willing to listen to that argument, but it hasn't been my
impression that that's the argument that we've been trying to
make.  If we make that argument, we're going to say most of
medical research is unacceptable, because the risk from tracer
studies is relatively small.

          DR. BUCHANAN:  I completely agree that the language was
not appropriately neutral, but I confess I don't know what
spurious ethical issues were raised by using the term laced, and
I had nothing in mind about whether tracer studies were
unacceptable.

          CHAIR FADEN:  Ruth?

          MS. MACKLIN:  I think the context in which -- I'm going
to defend you more than you are defending yourself -- in the
context in which Allen made the point was, the role of the
private sector, and the role of industry.  

          Now, whatever -- and, I take it that the question was,
if there was something wrong with feeding flavored oatmeal to
children or vulnerable populations, then part of the blame, part
of the culpability must lie with an industrial -- someone in
industry, whether it was in public or private sector, that
contributed.

          DR. BUCHANAN:  Or, it may lie, it's just a question.

          MS. MACKLIN:  Someone made the decision.  Now, I would
surmise that officials, managers, superiors and other people at
the Quaker Oats Company, were not medically or scientifically
competent to assess or evaluate what you are, Henry, so,
therefore, the question of their culpability in a larger picture,
where they are asked to do something for someone else and we're
going to pay you money if you will fix this oatmeal for us in the
way we want it, does raise the question of the integrity of those
people in the private sector who do it for money.

          DR. ROYAL:  I'm not at all questioning that, and I
agree that business shares the culpability, if there is
culpability.

          But, maybe the rest of you are not distracted by
someone saying that the oatmeal was poisoned by --

          DR. BUCHANAN:  I didn't say poisoned, I said laced, I
did not say poisoned.

          CHAIR FADEN:  You know what, I think that the point --
we can go with this for a long time, but I think that the -- if I
can just reconcile, I don't know about the language, I think it's
okay, but I think, if I understand your point, Henry, it's that
the way most people have been constructing the Fernald school,
the level of risk of harm to which the children were put, was
put, is less of an ethical concern than the fact that they
selected this institutionalized group of kids, as Jay reminded
us, they didn't go to -- they went to the Fernald School to
conduct the experiments, whether it was minimal risk, or low
risk, or high risk, the more troubling thing is that they picked
these kids and not some other kids on whom to do this experiment.

          And, Henry is right to point that out.  I don't think -
- we'll watch our language, but I don't know what else, I mean,
we should move on is what I'm saying.

          DR. BUCHANAN:  But, I do agree, it was poor choice of
words, I agree, and I apologize for it.

          CHAIR FADEN:  Thank you.

          We have Eli and Dan.

          DR. GLATSTEIN:  Along the lines of the relationship to
the industry, let's get back to Charles Wilson again, if I
remember correctly, he was affectionately referred to in the
papers as General Motors Charlie --

          DR. BUCHANAN:  Engine Charlie.

          DR. GLATSTEIN:  -- Engine Charlie, well, some people
called him in General Motors Charlie, because he came, as I
recall, from General Motors, and in his hearings he was quoted as
saying something to the effect  that anything that's good for
General Motors is good for the country, period.  That sort of
summarized it.  I think that was the beginning of the democratic
run on 40 years.

          DR. BUCHANAN:  Well, I mean, it's interesting, you
know, that this is a person who was at the top of the corporate
hierarchy in the private sector and then becomes the person at
the top of a government hierarchy, and it's worth thinking about,
about these intermeshing roles.

          CHAIR FADEN:  Dan.

          MR. GUTTMAN:  Internally, we've been doing a lot of
thinking about this question of industry and what Allen is
raising.  I want to just see if I can capsulize some of the
things.

          One is that, as someone who comes from a tradition that
actually spent a lot of time, you know as an adversary to
industry, and were acutely on the lookout for people making
money, that's terrible, but what really has been interesting
about this story, it's almost an abstract case of we are looking
at that part of the society, the professionals, the generals, the
civil servants, who are people think they are out there doing
good, they are not making money. 

          And, from the standpoint that they are making money,
but it's an incident, that they want the status, they want power,
these other terrible things, they want to win the Nobel Prize,
but, you know, it's not money necessarily.

          When I put this in the context of this discussion,
because I think this is a critical -- it's another of Ruth's
words, building block.  Pat King yesterday said, well,
professionals I understand, bureaucrats, bureaucracy, how you
deal with that, that's difficult, and this morning I think what
was part of the exchange with Henry and Ruth and Allen was, well,
how do the bureaucratic codes and the professional codes mix.

          I mean, today, Henry can say well I care about my
patients, but pieces of paper are secondary.  And, in one sense
that's obviously true, but in another sense, from the standpoint
of the public looking back 40 years, I think Allen and I was
saying it's not true, because how the heck does anybody know.

          Well then, you add this dimension of industry and
corporate, and I want to make a very interesting observation,
what's very, very profound about the work that we're doing, any
American citizen knows that if General Motors Charlie Wilson is
doing something, he's doing it to make money, so we question, the
red flag goes up in a second.  And, as President Lincoln said, if
it's a politician we'll all credit the politician once or twice,
but the second and third time we'll say, yeah, we don't believe
it.

          But, the people we are looking at are people who by
definition cast whatever they are doing in terms of good.  I
mean, I read the book on Robert Lifton, his Nazi doctors book,
and one of the things that's amazing, nobody in Nazi Germany,
they didn't say we are going to kill people, we are going to do
terrible things, they said we are doing this in the name of the
better German state or so forth, so that the critical task here,
and it goes to Henry's point, people are trying to do good, how
can you penalize them.  So, how do you help the society
understand how you separate out what is a rationalization of
doing good from what is a real doing good, and it's a different
question when you get into the corporate world, because we all
have our kind of instincts up when you see that there's money
attached to it.

          So, this is another building block, and you are putting
those, first you've got the bureaucracy, and then you've got the
professionals, then you've got -- we all have our detectors for
the business world.

          And, the thing I want to make as the final point, this
goes to the genome business, and we were talking about it earlier
on in the committee staff life with Charley McCarthy, who so many
of you know being in HHS, he pointed out that, you know,
President Nixon, when he was eulogized, one of his great
accomplishments was the war on cancer.  And, he said, you know,
that biomedical efforts which are emerging of bureaucracies, and
professionals and money are cast in these national good terms,
and that's, of course, Allen pointed out that the legislation,
one of the pieces of legislation in genome was the
Competitiveness Act, international competition.

          So, I'm just trying to say, I don't know if it's
helpful, but there's the framework in terms of the components of
what we are looking at is, you know, first you are looking at the
professional ethics, then you are looking at the bureaucratic
ethics, then it's all cast in terms of national good, and so as
you move forward respectively we are now looking towards a
redefinition of the national good, which will incorporate the
profit-making part of the world and how do those things mesh? 
And, it's quite -- as we see this morning, you know, everybody is
sort of side by side working together, but nobody really -- you
know, Henry doesn't see himself as number one obligation is
filling out forms, but a citizen might say, well, that's his God
damned obligation, is to fill out these forms, right.  And so,
it's the putting of the pieces together that is the real -- Allen
wants to comment on that.

          DR. BUCHANAN:  Well, I think that you've encapsulated
your career, which is quite exemplary.  I guess one concrete way
I would hook up with part of what you said is to ask this
question.  Was there, in the process of this, of some of these
episodes in radiation experiments, a phenomenon that you might
call misplaced status trust, that is, were people, because they
were part of the government, or the military, or were medical
professionals, given a presumption, was the guard let down
further than it should have been?

          I mean, there might have been kind of a synergism, but
it might be that the medical people, I'm sorry, the military
people in charge of getting some experiments going, deferred to
the doctors, thinking, well, the doctors are the people who know
the ethics of these things.

          The medical people may in some cases, for all we know,
have deferred to the military people saying, well, you know, this
is a military operation and we're in a subordinate position. 
This is the kind of invocation of status trust, that is trusting
someone, not because of the merits of the case on critical
examination, but because that person wears a white coat or wears
a uniform or whatever, and we don't trust the person that wears
the business suit in the same way, that's Dan's point.

          And, I think there are benefits to status trust that we
all can attain in some ways, the trust in a physician can be
actually therapeutic in certain ways, and in some sense a certain
amount of status trust in the government and the professions is
necessary.  

          But, there are also risks of status trust, and when you
get this kind of synergism of two or more groups that have this
kind of status, and that evoke a presumption of trust, and that
they are doing good, it's very dangerous.  I think we are seeing
in the radiation experiments how dangerous it can become.

          And so, I think that is a way of conceptualizing this,
and it's not to point the finger just at the military, or at the
medical people, or just at both of them, it's to recognize that
ordinary citizens also play into this by having certain
expectations of trust toward people who occupy certain socially
privileged positions.

          CHAIR FADEN:  I think you have just given expression to
something that a lot of people are seeing by body language to be
finding important.

          I see Phil and Reed.

          DR. RUSSELL:  That's a very important concept, because
I think the understanding of how something very bad can happen in
a system that's, you know, generally populated by good folks, the
interaction of expectations of somebody else can be watching the
store, as it were, may have played an important role here. 
Pursuing that line of thinking, I think, is very important.

          CHAIR FADEN:  Reed, and then Jay.

          DR. TUCKSON:  Yes, I also thought it was an important
comment.  The only thing I just keep also in my mind is even in
these good arenas, the human -- the incentive for human gain may
not be monetary, but in the academic environment we know people
will run over their grandmother to get that report out, because
it may not mean money, but it means status, it means something
more than money, or the same as money.

          In the military system, the need to get promoted, and
to have more power, and so I just think even within those, you
know, it's funny, the business suit versus the white coat or the
military uniform, at some level all of this stuff gets boiled
down to the same currencies.  It just may have different
translations, which I think is -- and also, as I say that, I also
still am finding myself in all of this conversation, I mean of
having been responsible for running large institutions and large
organizations, and one of the things that's real tough, I guess,
and this doesn't come up yet in our report so I won't say it much
yet, but who in their right mind would ever go into public
service today, and the point being that with -- as you look at
just what happens to you, and how the world just -- it's
impossible, and now on the one hand I've got this enormous
skepticism that comes from my understanding of human nature, and
good people don't call good people who are in systems that aren't
structured well, and where the incredible competitiveness among
human beings to get ahead makes us all do things that is of
concern, so I really am skeptical about a lot of things.

          On the other hand, I've got this schizophrenia that
reminds me that people that are in tough positions can't possibly
be accountable for everything that happens below them, and even
trying to make the doggone bureaucracy work with all of its
appropriate checks and balance, and if we come and beat the heck
out of the people that were at the top, unless they really were
crummy people, means that, again, you just don't get anybody to
go into public service ever again, because you can always,
always, every case, always go back and find enough stuff wrong,
and then go to the person at the top and say, boy, you were a
real jerk.  So, why take the risk?  Why ever go into public
service?  I'm schizophrenic.

          CHAIR FADEN:  I always, after committee meetings, I'm
always saying how quickly can we get the transcript.  I have to
say that this is one of the committee meetings that we'll really
need to get the transcript very quickly, there are some
extraordinarily powerful, eloquent and important statements that
people have been making these two days that we need to get
quickly so that we can make sure we don't lose them, not only the
thoughts, but actually the words themselves.

          Jay.

          DR. KATZ:  Well, one comment with respect to what you
just said, the comments about Allen's remark, I think it might be
useful to get the transcript.  But, if you get the transcript, I
think at least what I would learn from the transcript, how long
it will take us to really think through the various competing
issues raised by committee and our consultants.

          To do this job, and I'm probably going to say it again,
but to do this job by May in a proper kind of fashion to my way
of thinking is useless, but I want to leave that alone and not
bring this up for discussion.  We can discuss that some other
time.

          But, Allen, I think you are quite right, what you point
out about the concept of the status person, and since Dan Guttman
makes me read everything, and he's sending me materials, and
sometimes he sends me materials twice and three times, so I think
it's new material so I read it again, and if you look at the
meetings --

          MR. GUTTMAN:  That's what I send Doctor Katz, his own
works.

          DR. KATZ:  -- if you read the various committee
meetings and the various panels, you'll have evidence, you know,
again and again of doctors deferring to the military and the
military deferring to the doctors, and everything falling back,
you know, whether that is important knowingly in the sense of
that they want to have things fall between two stools, so that
nobody is responsible, everybody assumes that the other will take
care of things.          I think they were not, in their
deference, I don't think they were quite as innocent as one can
say they were, that this was an expectation that the physicians
will behave one way and the military will protect other kinds of
things.

          And, again, you know, it goes back to the question that
we've been debating.  What can we say about this with respect to
the future, is how we can alert medicine and public government of
the dangers, and it comes up in all kinds of medical matters or
research matters, having independent auditors, you know, which
create the same kind of problem of the investigator being
responsible for one thing and the independent auditor being
responsible for other things, and nobody being responsible for
everything, and things falling between two stools.

          So, it still leaves us with the question, how do we
want to evaluate the past?

          DR. BUCHANAN:  Well, and what recommendations for the
future also.  I mean, I think one sort of simple answer to your
question, well, what do you do about this problem of status
trust, given that there are secondary gains, that there are
functions intraserved by people playing into this, well, I think
one thing you can do is to put up a warning sign that says, in
effect, that where ethical issues are concerned, deference is not
appropriate, that there is no escape from people exercising their
own judgment about ethical issues and about risks, and that the
mistake is to think that because someone has expertise as a
biomedical researcher that they have expertise in identifying and
resolving ethical issues.  They may, but that's a contingent
fact, and depends upon what kind of person they are, and what
their special training has been, and all that.

          So, I think there are some general kinds of admonitions
that can be directed toward the problem of status trust, but you
are quite right to point out that the reason it's so ubiquitous
is that it produces gains for almost everybody involved.  The
gains are not equivalent by any means, but they are really there. 
It has a functional role to play.

          Could we maybe just look over, I don't know if people
really had time to read this thing, it's longer than I hoped it
to be, but are there any specific questions about it?  Does it
look like it's in the right ball park?  It obviously needs
enormous refinement.

          CHAIR FADEN:  I would like to, if we could just maybe
spend five minutes on that, and then move on, because I want to
make sure we get on to -- at least introduce it today before we
close.

          But, I'd like to, in line with that, pick up on one
part of, Reed, your comment.  If you read your document, or your
draft, in fairness, Allen, it doesn't seem to take account of the
human dimensions of what Reed just described for people on the
very top.  The expectations seem fine in a formal sense, but as a
practical and human matter, you are talking about something like
the size -- Reed, I was wondering as you were talking about that,
about what it must have been like to run the health department
for the District of Columbia, for example, as a concrete
illustration, or the Department of Defense for that matter, or
the Department of Health and Human Services, and you are to be
absolutely accountable in this complete sense for -- I mean, do
you mean it as it reads, Allen?

          DR. BUCHANAN:  Well, I mean it, I wouldn't retract
anything that's said, I would just add a lot.  And, one of the
places to add something comes in where I talk about the personal
cost that someone might bear in blowing the whistle.  Okay.

          And, the way I think of all of the obligations involved
is that they occur within the context, and they are to be
understood within the context of a recognition that people have
legitimate interests in their own career and how their families
fare if they lose their jobs, et cetera.

          And, there are certainly, even one says that, you know,
you have an obligation to blow the whistle if some serious harm
will otherwise result to the public, there are questions about
the limits of that obligation, and it's not inappropriate, and no
moral theory that I know of would say it's inappropriate, to take
into account the costs of being ethical in some sense, within
limits, that is, think about something like a duty to rescue. 
Okay, the duty to rescue is a standard example of where the scope
and limits of the duty are hedged by a no excessive cost kind of
clause that goes with it.  It may be one thing to say you have a
duty to perform an easy rescue, but that doesn't mean you have to
dash into every burning building that you ever encounter and save
whatever stranger may be there.

          So, I think part of what this needs is a recognition
that legitimate self-interests and consideration of the personal
cost do play a role in determining the stringency of obligations,
and that it's inappropriate to hold bureaucrats to excessively
high standards, partly because of the deterrent effect that Reed
mentioned, that you'll just winnow out some of the best people,
people who take their obligations seriously.

          I think all of that has to be said, but I don't think
anything in here is contradicted by that, though, I think that
not having mentioned those things, or not mentioning them
explicitly and elaborating, gives a very misleading cast to this
as it stands, and certainly reasonably provokes the fears that
Reed has and the ones that you've voiced.

          CHAIR FADEN:  Reed.

          DR. TUCKSON:  Actually, you use an important word on
the first page that struck me on this, and that was under 3A,
obligations of superiors to take reasonable steps.

          DR. BUCHANAN:  Yes, that doesn't mean to guarantee,
that doesn't mean no matter what.

          DR. TUCKSON:  And, I think one of the things that as we
go back and look at this is, I think, first of all, I mean,
generally, I like what you've got here, I mean I think this is
absolutely the right track.

          Now, the notion is, does the system that the person is
managing have an opportunity to do the things that we would
expect it to do and that person to do?  If the system is so
flawed then ultimately -- let's say the person comes in, and
you've got 14 pathways that don't work, and they spend the first
-- let's say this Wilson guy or whoever, just anybody, spends two
years trying to fix the system and stuff happens in those first
two years that aren't so great, it's then -- is it do you hold
accountable the people or do you hold accountable the sponsoring
organization, i.e., government, that caused there to be a
dysfunctional system that required all that work to get squared
away.

          So, in other words, is it -- I mean, a good person can
come in and do something in a bad situation and do it well, but
because -- but it could look horrible, could be held accountable
as being crummy.  And so, I guess the question becomes is then,
do you transfer that accountability from the individual to the
sponsor that permitted, even if was back in 1793, that got that
organization off to a bad start and created an environment in
which the institution was dysfunctional and, therefore, had to be
fixed.

          DR. BUCHANAN:  I think that's a mitigating circumstance
of a whole range of mitigating circumstances.  It may be that the
person did the best that he or she could within the impoverished
resources of that institutional organization.  All the incentives
were in the wrong direction.  And, that has to be taken into
account in making any judgments of culpability, you know, for
what the person was able to do.  I think that's extremely
important.

          DR. TUCKSON:  So that, if there are discussions about
an ethical -- if there's an ethical discussion that is occurring,
and you start to build this ethical train, but the tracks by
which that ethical train has to travel are in disrepair, and the
train doesn't get where it is supposed to go, do we go back and
have to explore the why of the train track not being available,
or do we just simply say that because the train of ethics was
built they darn well should have made sure those tracks got
created, such that that information could get where it needed to
go?

          DR. BUCHANAN:  I guess I don't think it's one or the
other.  I mean, I think if there are structural defects in the
system that really constrain even people with the best of
intentions from doing well, that needs to be uncovered.

          That's part of what I was trying to get at in saying
that especially for the forward looking suggestions, we need to
emphasize that part of what it is to have a good organization is
to have -- is to do what one can to have clear lines of
responsibility so that good behavior can be rewarded, bad
behavior can be corrected or penalized, and so that people know
what their responsibilities are, so they are not able to take
this easy way out of saying, well, it fell between A and B and no
one was responsible.

          So, structural improvements are really important, and
if the structure is bad enough then that will really mitigate
judgments you make about how people were able to operate within
them.

          But, I don't think it's one or the other, I think it's
both.

          DR. TUCKSON:  And then in the final analysis, when it's
all said and done, at some level there, I think, what this gets
to is, regardless of then all these concerns which I think we
have to have for the individuals and the players in the drama,
for the person at the end of the rope who has been victimized,
they could give a hoot about any of that, because the bottom line
was the train ran over them.

          And so, therefore, there seems to be that when all the
smoke clears, regardless of who you can or cannot point the
finger at, there is some entity that has to take the weight,
because in reality something did go wrong.

          DR. BUCHANAN:  I think that's right.  I mean, you may
know that, you know, there must have been something defective in
the organization, and you can have some idea of where some of the
defects were, you know that the outcome was bad, and, perhaps,
even that there was a violation of someone's rights, but you may
not be able, simply because of the defects of the organization,
to locate exactly were things went wrong.  Okay.

          But, that shouldn't stop you from saying, yes, the
outcome was bad, and yes, in some cases, perhaps, someone may be
owed compensation or you recognize that their rights are
violated, and maybe the most you can say in some cases is that it
was a structurally defective organization and that the lines of
accountability are so unclear that we can't even focus attention
on individuals for being responsible for this bad outcome, but
the organization in some collective sense was culpable.

          By the way, I mean this handout comes from some longer
analyses that I've done under my business ethics professor hat of
real cases where there were breakdowns in organizational
behavior, the Air Force brake scandal is probably the one that
I'm most familiar with, where there was lying about tests that
were performed on some brakes for an airplane that the Air Force
was contracting to a company for.  And, the reason I emphasize so
much these issues about obligations to select personnel to
monitor performance, to create a condition in which
accountability can be assigned, is because that's what really
goes wrong in these cases.  It's not that there is some simple
ethical rule that somebody violated.  It doesn't tell you much to
say they violated the rule of, you know, not telling the truth in
what they said about the test.  What you need to know is why this
occurred, where there was a failure of leadership, where there
were failures to monitor people's behavior, where there was a
corporate culture that was encouraged which discouraged
criticism, which prevented people from speaking up early on in
the process and forced them to be whistle blowers at the end of
the process, after the damage was done.

          Those are the kinds of considerations that went into
this rough outline, and I think that, you know, you have to
connect that with the question of these overlaps of cultures with
the status trust from different things, you know, different
cultures coming in.

          DR. TUCKSON:  The last question --

          CHAIR FADEN:  Last question for Reed, and then Ruth,
and then I think we do need to switch topics.

          DR. TUCKSON:  Okay.  Just for the leader now, so that
we've gone through it, I just want to step back again into the
maze again for a minute with the leader, if the leaders can
choose what they make as priorities, they can either decide to
have performance widgets that says I'm going to get so many
widgets done, and that's the thing, we are going to get this
done, or they can decide to spend a lot of energy and emphasize
the ethical moral mandate.  Do we need to be concerned as we look
at the ethics of the physician investigator, at that level, do we
need to understand any of the ethical climate of the time for the
managers, for the leaders?  Do we need to say, in other words, if
there was a prevailing standard in the world at that time that
said, the ethical considerations for what you do are
fundamentally important, and if you don't pay attention to that
as a matter of high priority, if we go back and look at your list
of priorities as a manager and we don't see that in it, then that
says something that you really didn't pay a lot of attention to
this and you didn't do well.

          On the other hand, if nobody cared about that much at
that time, then -- in other words, do we need to -- does this
concern for the ethics of the bureaucracy cause us to understand,
or do we have to expend any energy on that historical period of
ethics for just leaders and managers of major institutions such
as we are exploring in the same way that we're finding ourselves
exploring the ethics of that time for physician investigators?

          DR. BUCHANAN:  Well, you know, my first thing is to
say, oh, yes, let's do that, but then I remember Jay's earlier
remarks that we're operating on limited -- you are operating on a
limited time frame.

          I guess my sense from looking at what I know about the
history of ethics in organizations is that it's probably a
mistake to say that it's only a very recent contemporary
phenomenon that ethical issues have been thought of as being part
of the role of leadership.

          I think that it's always been there, it's been under
different names, and sometimes it hasn't been labeled as ethics,
but I guess I would avoid the conclusion that there's been a huge
sea change, that there's really entirely different culture of
management with regard to ethical standards in the recent past,
20, 30, 40, 50 years ago than today. 

          There are certain areas of ethical concern which are
newly prominent, like, say, environmental ethics.  Almost every
organization now has to take into consideration questions of
ethics concerning the environment.  But, issues about truth
telling, about not inflicting harm on innocent people, about
treating people respectfully, not exploiting vulnerable people,
those things are, I think, pretty constant.  They might not
always go into the same labels, but I guess what I'm suggesting
is, without having a lot of data to back it up or having thought
it out, is that it would be a mistake to assume that there's been
a huge change in the self-understanding of managers and
bureaucrats as to what their duties are.

          The basic issues about conflict between role obligation
and independent external moral obligations has always been there,
right, I mean it's there with Agamemnon when as Commander and
Chief of the Greek Army he thinks it's a good idea to sacrifice
his daughter so that the war would go well, but on the other hand
he's got these obligations as a father not to sacrifice his
daughter.  I mean, these are not new conflicts, they've always
been there.  They take different guises.

          CHAIR FADEN:  Ruth, how about if your's is the last
comment, if that's agreeable to everyone, and Allen has a quick
response, so that we can get in one more topic.

          MS. MACKLIN:  Okay.

          I find this a very solid and useful framework, and
there's no but that follows that.  I find it a solid and useful
framework.

          The only but is -- it's not my but, I'm sorry that Pat
is not here.  

          DR. TUCKSON:  I know, she asked for this.

          MS. MACKLIN:  The reason that Allen spent the evening,
his otherwise precious time here in Washington, doing this is
that Pat made the observation yesterday that we lack for
bureaucracies what we have for professionals.

          Now, one of the elements, I guess, or one of the ways
in which we understand what the obligations are of professionals,
is that professionals understand their obligations that way, so
you can move back and forth between what a sociologist might say,
yesterday Jonathan Moreno said it's too bad we don't have a
sociologist here to tell us about the bureaucracies.  I said,
well, a sociologist might describe, but, of course, what we need
is the normative account which Allen has given us.  But, there
may be instances in which an ethical analysis of what
professionals that their obligations to be, there may be
instances in which they diverge, but pretty much the way we
understand what professionals do, what doctors do, what they feel
they ought to do, and lawyers as well, is fiduciary obligations
within the profession that are accepted by the profession.

          Now, that's an introduction to my question, okay, which
is, Allen, do you think that since we don't have the same thing
for bureaucracies, since there are many sorts of bureaucracies,
we may have to ask specific questions about the military, and
then business is a very loosely structured thing, you have given
us here, I think, simultaneously what might be called a
descriptive account of obligations, of a structure of bureaucracy
and what obligations exist, but with normative force.  I mean,
it's not purely normative, you are not saying you ought to do
this and that, but it's within the structure of what
organizations are, I mean if I understand what you've done here.

          So, my question is, would, do you think that people,
managers, subordinates, superiors, and all the others within
organizations would recognize this after duly studying it,
reflecting on it and deliberating on it, would recognize these as
their obligations and say, you know, well, this is partly
descriptive, but, yes, this, in fact, captures what we're about
in a bureaucracy, or they can say, what's this, I mean, some
philosopher sat down and wrote this stuff.

          DR. BUCHANAN:  No, this has actually been tested in the
real world to some extent.  I mean, as I said, I teach business
ethics, and a lot of my students are business people who are
coming back to school to get an MBA, and I also talk to, you
know, groups of executives, and we analyzed cases where things
went wrong, where there was some --

          DR. KATZ:  Do you really believe this?

          DR. BUCHANAN:  Do I what?

          DR. KATZ:  Do you really believe this, that people
would agree with this, and as soon as it got through
implementation, I mean, as the Ten Commandments, yes, and that
this should -- that's fine, but when it comes to implementing and
acting on these wonderful principles that they wouldn't begin --

          DR. BUCHANAN:  Well, let me put it this way, the
response that I get from real business people, not academics, but
people who are in positions of managerial authority, is that
quite apart from whatever independent ethical grounding as such
these kinds of guidelines have, in the long run and on average
the best way to avoid disastrous outcomes in your organization
which will get you in trouble with your stockholders and possibly
in trouble with the federal government in matters of litigation
is to exercise responsibility and leadership and management,
which means making it clear to people what their responsibilities
are, creating a climate in which people feel free to engage in
responsible criticism, so the disasters are headed off.

          I mean, take the Apollo disaster, there is an excellent
video on what the corporate culture was at NASA which led to this
problem.  And, it's very similar to the sad analysis of the Air
Force brake scandal, and that is, it was a corporate culture in
which lines of responsibility were not clear, and in which
constructive criticism was discouraged and penalized, and in
which personnel appointments were made that put people in
positions of leadership who would not tolerate criticism of their
own conduct.

          What I'm saying is that the reaction that I get from
business people is that from the standpoint of prudence, not just
from the standpoint of morality, but from the standpoint of
prudence these are -- they might not always call them principles
of ethics, they might call them principles of wise management, or
principles of leadership, that is, to be a good manager, to be
somebody who can be relied upon to produce results over the long
run, which are good for all the stakeholders involved, these are
the kinds of things that you need to do.

          And, I mean, you know, maybe they are telling me what I
don't want to hear.  I can't imagine why they would.  The
students might, because they might think their grade depended on
it, but when I do executive seminars for people who make ten
times as much money as I pay in taxes, and who command positions
of authority over thousands of people, I can't imagine why they
would tell me that this is just, you know, that this is stuff
that makes sense to them if they didn't believe it.

          But, this is not to say that in the -- I mean, I'm
agreeing with you, in the concrete situation there may be strong
and in some cases overwhelming temptations for people not to
follow rules which in a cool moment they recognize to be
prudential, sound policy rules.  That kind of temptation to do,
you know, to not do what you think on calm reflection you ought
to do occurs all the time, but doesn't just occur with moral
principles, it occurs with principles of prudence as well.

          CHAIR FADEN:  I'm very torn here, because I can see
that -- Nancy, did you want to make a comment?

          DR. OLEINICK:  May I just add one thing here.  I think
again that I think this is a very useful document to help us all
think this through.

          One thing that I thought was not in here, at least not
directly, was the whole role of advisory committees in a
bureaucracy, and since many of the situations that we are
concerned about depend upon advisory committees to the Department
of Defense and the AEC and so forth, I would like to hear what
your thoughts would be on how they interacted with the
bureaucracy, and how they should interact with the bureaucracy.

          Don't answer now.

          DR. BUCHANAN:  It's an incredibly complicated but good
question.

          DR. THOMAS:  There is an excellent book on this subject
called Advise and Dissent, which I read quite a few years go.

          CHAIR FADEN:  Maybe we should all read it.

          DR. THOMAS:  Must reading for all of us, yes.

          CHAIR FADEN:  Yes, given that we also are, by the way,
an advisory committee, in case anyone hasn't noticed.

          But, I am, as I said, really torn here.  I think we
probably need to switch, if that's okay, work with Allen's
material and thank him for giving up his evening last night.  So,
hang with us here, we are going to switch gears and, Wilhelmine,
if you could come up, this is a big shift in the agenda topic, we
are now on contemporary agency oversight, one of the charges of
the committee is to look towards the future.  We have had lots of
oblique and direct references to what some people have called
future remedies and other people have said we've got to make our
recommendations for the future, how we set things up for the
future, perhaps, is our biggest legacy and so on.

          And so, in order to start that discussion off, we need
to have some understanding of what's going on currently, and
Wilhelmine has been working hard at this task with others.

          If you could turn to, I think it's Tab H.

          MS. MILLER:  The memoranda at Tab H provides a
background for your discussion today of current federal policies
that govern human subject's protections.

          The first memorandum briefly traces the development
over the past 20 years of the common federal policy for human
subject's protection known as the common rule.  It summarizes the
major provisions of the rule, such as the procedures for
Institutional Review Board approval of research studies involving
human subjects, the negotiation of institutional assurances
between a sponsoring federal agency and the institution
conducting the research, and the elements that are required in
the informed consent process.

          The second, longer memorandum characterizes the nature
and scope of the research involving human subjects that the six
agencies that come under the purview of this committee of those
agencies, the locus responsibility for human subject's
protections within each of the agencies, and the administrative
practices of each agency in carrying out these activities.

          Now, this information was provided to us by the
agencies in response to a standard set of questions that was
posed by committee staff earlier in the summer and we continued
to develop this information in correspondence and conversations
back and forth, and we're still learning about their current
practices and about the, you know, changes and policies that are
even under consideration in the various agencies at this time.

          So, it's by no means a finished story that is very
briefly described.

          In this briefing memo, we've given particular attention
in the discussion to the various exceptional circumstances in
which the common rule grants that the Department Secretary or an
agency had the discretion to waive or modify any of the
requirements of the common rule, the sanctions or responses to
non-compliance with the human subject's protections that the
agencies have the authority to employ, and a determination of
whether or not the agencies now conduct, or even have the
authority to conduct, any classified research involving human
subjects.

          This review of the current policies is meant to provide
another frame of reference for, you know, your review and
consideration of past ethics policies, and it can be one point of
departure for future oriented policy recommendations that the
committee might have.

          CHAIR FADEN:  Thank you.  There's a lot of information
here.  The floor is open for questions.  Every should know, Anna
is reminding me, I didn't pay attention to my blue folder, so if
you also have not looked at everything in your blue folder,
there's a revised H2.

          MS. MILLER:  Right.  You received a draft a week ago,
and then --

          CHAIR FADEN:  So, you should throw out the one that's
in your briefing book and put in the new one, and you've got two
versions of the new one, a red-lined one that shows the
differences between the old memo and the new memo, and then if
you don't want to bother with that there's just a clean, new
copy.

          Phil, do you have a question?

          DR. RUSSELL:  I have a few comments on the content of
this.

          CHAIR FADEN:  Please, let's start.

          DR. RUSSELL:  With regard to the Department of Defense
on page ten --

          CHAIR FADEN:  Which, are we talking the new one, the
old one?

          DR. RUSSELL:  This is the new one, the revised one.

          CHAIR FADEN:  Okay.

          DR. RUSSELL:  There's a statement that says, "Clinical
research, diagnostic therapeutic research involving patients,
takes place only within military medical facilities."  That's not
true.

          And, the confusion lies in the use of the term
"clinical research," which in the service is a special funded
program, funded by Program 6, not R&D funds, that does support
clinical research within the medical facilities.

          There is a lot of research funded by Army and Navy
research funds that is done on patients now for the purpose of
therapeutic, improving therapy, and it's done under contract, and
one of the large areas that you don't deal with here is the whole
issue of conducting research in foreign countries on malaria
patients, for example, and in conducting vaccine trials such as
hepatitis trials in foreign countries.  And so, I think you need
to correct the misimpression that this is giving here, and that
is repeated over on page 11 on the second paragraph, that
services do conduct a large intramural clinical investigation
program, but that's not the only place they do it.

          MS. MILLER:  Okay, thank you.

          I didn't get into the discussion of foreign based
research, simply because I didn't have time to deal with it. 
That is a very important element.

          DR. RUSSELL:  I think it's an important one to include,
because it actually requires in some instances the setting up of
institutional review boards in the institutions in foreign
countries, and it also required us to ask the national
authorities of the Ministries of Health to set up oversight
organizations to monitor that, which are in place.  

          Those were the main points I had.

          CHAIR FADEN:  Nancy.

          DR. OLEINICK:  I just had a question also, I guess it's
also on page ten.  If you'll just help me to understand what you
mean here.  "Under the funds appropriated to the Department of
Defense may not be used for research involving a human being as
an experimental subject unless ...," and then there's two
conditions.  The second condition, who is a legal representative
of the subject, and are military officers of that subject
considered legal representatives?

          MS. MILLER:  That's a good question.  This is the
statutory basis for the informed consent requirement for DOD.  I
read it to mean a family member, but --

          DR. OLEINICK:  Well, that's one interpretation.

          MS. MILLER:  -- maybe Doctor Russell can-- but I never
considered that it might also be a commanding officer.

          DR. RUSSELL:  No, it's most certainly not a commanding
officer.

          DR. OLEINICK:  It's not, okay.

          CHAIR FADEN:  If we could just maybe pull out some of
the main points of the memo and see if I've got it right.  With
respect to oversight, and I know that's just -- so I guess you
still don't have an answer, but let's get it out, on page 11,
again for the Department of Defense, there is this estimate that
just over 100 full-time equivalents are devoted to oversight of
research involving human subjects.

          MS. MILLER:  Right.

          CHAIR FADEN:  Do we have any better understanding of
what that means, for example, are we confident that does not
include members of IRBs?  I mean, are these --

          MS. MILLER:  It does not.

          CHAIR FADEN:  It does not.

          MS. MILLER:  This is a staff time estimate, and it does
not include the time spent in IRB meetings.  

          CHAIR FADEN:  These are 100 full-time equivalents whose
job it is --

          MS. MILLER:  As I understand, it may be many more
people, but if you were to put together the time spent by an even
larger number of people processing the paper, writing the rules
and auditing the practices in clinical facilities and research
facilities, it would amount to this.

          CHAIR FADEN:  And, this would include also oversight
with respect to research done by contract.

          MS. MILLER:  Right, it would.

          CHAIR FADEN:  Not only research --

          MS. MILLER:  Done in the facilities.

          CHAIR FADEN:  Now, do we have a number, the amount of
dollars spent by the Department of Defense on research involving
human subjects, so that we can put this in perspective?  Do we
know what the Defense Department --

          MS. MILLER:  This is a question we posed to every
agency, and only a few agencies were actually able to calculate a
human subjects research dollar value.  Many agencies are working
on the kind of data systems that would allow them to distinguish
quickly what experiments do involve, humans or not.

          It's in here if it's available, and it's not in the
memo.  

          CHAIR FADEN:  So, we don't even have a ball park.

          MS. MILLER:  No.

          DR. RUSSELL:  Records aren't kept that way.

          CHAIR FADEN:  So, we have no way of -- so when we have
the figure for HHS, they do keep it by human subjects versus non-
human subjects?

          MS. MILLER:  Yes, they were able to make that estimate,
it was $6 billion, I believe.

          CHAIR FADEN:  Used on research involving human
subjects?

          MS. MILLER:  Human subjects, right.

          CHAIR FADEN:  And, they have how many full-time
equivalents?

          MS. MILLER:  I think it's 14.  This is only -- that
isn't -- the number of people within the NIH Office For The
Protection Of Research Risks is only a fraction of the number of
people who spend some time reviewing research proposals to ensure
that human subject's protections have been met, so it's not a
comparable figure.

          CHAIR FADEN:  So, what we need is the comparable
figure, and we need the comparable figures on both ends to get a
general sense of how the agencies are handling it.

          DR. RUSSELL:  It's got to be in the thousands.

          CHAIR FADEN:  Yes, I mean that's the awkwardness here. 
We need to have this.  We don't have a denominator in terms of
the research budget for the Department of Defense, and we have
this figure of 100, and then we have this large number of dollars
spent by HHS, and then only the staff --

          MS. MILLER:  Of one unit --

          CHAIR FADEN:  Right.

          MS. MILLER:  -- which is a policy-setting unit, and a
unit that negotiates assurances of institutions, but does not --

          CHAIR FADEN:  Not a very important unit, and we also
don't have the FDA.  

          MS. MILLER:  That's right.

          CHAIR FADEN:  So, somehow we need to flesh that out a
little bit and get a better picture of how oversight, in fact, is
managed, and I single out these two institutions, these are the
largest, but we need it also for DOE and the other agencies, in
ways that translate equivalently or something, or roughly are
intending to get at the same kinds of figures if we can do it.

          DR. RUSSELL:  It's not going to be easy, because
there's a large number of people in these bureaucracies that have
some level of responsibility to deal with the human use aspects
of it, but that's only a small part for a general contracting
officer.

          A contracting officer who monitors a set of contracts,
has to look at that and see to it that the boxes are filled in.

          There's other people who look at it full time, but he
spends a lot of time on it, or she does, so estimating the amount
of manpower, person power needed to manage this is going to be
very difficult, and across bureaucracies is going to be even more
difficult.

          CHAIR FADEN:  Well, maybe it's not doable, but I'm
trying to think of some way to attack this that's coherent in
trying to figure out what's going on now and see what the
suggestions would be.

          MS. MILLER:  I have been told that it's impossible to
estimate, but I can go back and ask again for some guesstimate.

          CHAIR FADEN:  Well, if we can figure out who these 100
full-time equivalent people are, what they are thought to
represent on the part of the Department of Defense, then we can
go back and say, well, how would you do it at HHS or DOE if you
were trying to put up the same kinds of responsibilities being
conducted.  I don't know what's behind this claim on the part of
the Department of Defense.

          DR. RUSSELL:  Where did that come from?

          MS. MILLER:  It actually came from testimony or
questions, answers to questions posed by Senator Glenn in a
hearing in January.  I don't think that the Department
necessarily wanted to recalculate it or have this be used, simply
because they were uncomfortable with the quality of the estimate.

          CHAIR FADEN:  I bet.

          MS. MILLER:  But, we can ask again.

          DR. RUSSELL:  It's a guesstimate, I'm sure.

          CHAIR FADEN:  Yes, I'm sure it is.  I'm just trying to
figure out, either we ought not to use numbers like this, because
they are not meaningful, or we ought to try to get something that
helps us understand what's going on from agency to agency. 
Otherwise, we're kind of at sea.

          DR. RUSSELL:  The amount of personnel committed to this
task I think is very important.

          CHAIR FADEN:  Right.

          DR. RUSSELL:  And, it is big, it's very large.

          CHAIR FADEN:  Can we figure out dedicated full-time
people?

          DR. RUSSELL:  Exactly how to do it, I don't know.

          MS. MILLER:  I think the problem is that there are very
few identifiable full-time staff, but many people have it as part
of their duties.

          CHAIR FADEN:  We could start with that.

          MS. MILLER:  Especially in the smaller federal
agencies, agencies with a smaller human subject.

          CHAIR FADEN:  Even if we started with that, that would
be something, and that's the equivalent of the 14 people on the
staff of OPRR, presumably, or something of that sort.

          MS. MILLER:  Right.

          CHAIR FADEN:  So that we could see how many -- what's
the full time -- the core people whose full time job it is to do
nothing else but something having to do with oversight with
respect to human research, and then branch out to all the people,
say, it's half time of their work, and then the people who spend
ten minutes a day on it, I'm much less interested in knowing
about.

          Ruth, did you have --

          MS. MACKLIN:  It's not on this point, it's a different
point.

          CHAIR FADEN:  No, it's okay.

          MS. MACKLIN:  I'm interested in the material under F on
page nine, the FDA waiver of informed consent requirements for an
investigational new drug and vaccine during Operation Desert
Shield/Storm.  This is one of the few contemporary examples we
have of a military -- of an activity in which the military and
some research drug or device come together.  I mean, maybe there
are others, I just don't know, maybe I shouldn't have put it that
way, it's the only one that I know of.

          So, it provides maybe a unique example to look at the
way that current regulations that are now in place can apply or
do apply in a situation of, I don't know what the right words are
here, military action, war time, quasi war time, something like
that.

          And, I think I would like to see more discussion of
this, because I think this has very much to do with questions
about the future or what we can recommend, because here's an
opportunity to see how current, up to date, very much up to date
regulations of people who know about these things seek and obtain
waivers.  Okay.

          Now, I don't -- this doesn't tell me enough, I mean
what's under this tab.  For example, I mean I read it, and I
reread it, and I keep going back and forth.  I mean, the second
paragraph refers to the provisions of FDA regulation allowing for
emergency treatment use of investigational products.  Now,
treatment use of investigational products, on the one hand one
can ethically justify if, for example, there is sufficient
evidence from trials that have been conducted up to a certain
point and yet the product doesn't yet have FDA approval, and yet
the evidence from existing and past trials suggests that this is
an efficacious agent for this purpose and, therefore, it might be
unethical to withhold it as a treatment just because it hasn't
yet been passed, et cetera.

          So, I mean, that's sort of the context.  But, I
couldn't begin to say whether this stuff, what's this stuff,
pyridostigmine bromide, a drug licensed for another use, proposed
as an adjunct agent for preventing nerve gas poisoning, et
cetera, could qualify for the conditions that I mentioned.

          So, I mean, I'd like to know more of this story, in
particular because there has been some discussion in the
bioethics literature with some people being highly critical of
what they thought was an abandonment of the requirements of
informed consent during Operation Desert Shield/Storm and others
defending it.  So, I mean, I think it may be interesting as a
contemporary example, and I'm not making judgment because I don't
know it yet.

          CHAIR FADEN:  Jay and then Phil.

          DR. KATZ:  One comment about this.  I would wonder
whether we ought to look into that.  It's a very complicated kind
of story, and I would have to have read a lot of the documents
and court cases, et cetera.  Then, it has all kinds of interests
and complexities.  Then, in a very overall -- as an overall
judgment, they really handled the situation pretty well and with
sufficient openness, so it raises all kinds of interesting
issues.

          If we get involved with that, even though it's a
judgment issue maybe the committee and I can send you some
additional documents that you might want to review on the matter,
including the D.C. Court of Appeals cases.

          MS. MILLER:  Right, I have those.

          DR. KATZ:  But, it's a very complex kind of story the
way it was written.

          CHAIR FADEN:  Phil.

          DR. RUSSELL:  I think I can provide a brief answer to
some of your concerns.  Pyridostigmine is a drug that has been in
the Pharmacopeia for years as treatment for myasthenia gravis. 
It binds to cholinesterase enzymes, and its use in protection
against nerve gas poisoning is called pre-treatment because it
doesn't provide any protection, but it does allow for a much
higher level of survival if combined with treatment after
exposure.

          So, the problem the military faced was that there's an
immense database in monkeys that shows that you save lives of
monkeys challenged with the nerve agent if you pretreat with
pyridone and subsequently use this standard Army drug system for
post-exposure treatment.

          We have been developing the information in experimental
animals and at the same time doing extensive studies on the
safety of quite low doses of pyridostigmine in military
populations.  So, the database was quite large, and for some very
convincing.

          The catch-22, as it were, is that the FDA requires
proof of efficacy for a use.  There's no way in the world that
you can get direct proof of efficacy, and so the FDA has been
struggling with the issue of indirect proof of efficacy for many
months prior to this issue.

          At the time of Desert Shield, the judgment was made
that the value, the protective value of this drug far outweighed
any potential hazards of the drug, and that the DOD should go to
the FDA and present its case and get a waiver, basically, of
investigational status.  So, that's what was done.

          I think the studies done subsequently showed that in
some individuals there were some gastrointestinal side effects,
but they were very minor.  There's no evidence of any major
untoward outcome of the use of the drug.

          MS. MACKLIN:  So, let me just understand.  I mean
that's very helpful.  What it says here, what I understand, is
that the waiver was under the emergency treatment use of
investigational products, the waiver was a waiver of informed
consent.

          Now, I mean, we have to put two things together.  One
is the use of investigational products for treatment purposes,
and the second, which I consider quite different, is the waiver
of informed consent.

          DR. RUSSELL:  But, again, there's the -- if the drug is
investigational, then you have to have informed consent to give
it.  It's investigational because it couldn't be licensed because
we couldn't prove efficacy in the formal sense.

          The informed consent issue was not related to an
experimental use, it was related to the legal status of that drug
as an investigational drug.  And so, I think there are two legal
requirements for informed consent.  One is to do an experiment, a
medical experiment, whether or not there's a drug involved, but
there's also a legal requirement to use informed consent if a
drug or a device is investigational.

          MS. MACKLIN:  Well, if a soldier in battlefield
conditions, or in something like this, setting aside experimental
or investigational products for a moment, if a soldier fell ill,
and a military officer or physician wanted to treat that soldier
with a certain drug, could the soldier refuse?  In other words,
do you have to get informed consent for a treatment purpose in
the military?

          DR. RUSSELL:  Yes, military treatment purposes, or
military treatment is generally the same rules.  I'd have to look
into some other --

          MS. MACKLIN:  I mean, the reason I ask is that you --

          DR. RUSSELL:  -- he can't refuse to go a hospital, for
example.

          MS. MACKLIN:  But, I'm talking about refusing the drug.

          DR. RUSSELL:  But, once he's there, his treatment, you
have to get his consent.

          CHAIR FADEN:  Phil, on that point, can a soldier refuse
vaccine before going into battlefield conditions where there's
epidemic disease?

          DR. RUSSELL:  No.

          CHAIR FADEN:  So, somewhere in between this is.

          MS. MILLER:  Yes.  I think what makes this a very
distinct use would be the emergency treatment provision which is
in the FDA regulations for investigational products, is that it
was a new case of prospectively waiving, as opposed to a one-time
-- the paradigm case would be an emergency treatment use where
informed consent cannot be given and an investigational product
is used to treat, and after the fact an IRB might be informed.

          In this case, there is a prospective IRB review and
recommendation that the use is justified in the best interests of
the military personnel.

          So, this was included here in, perhaps, too brief form
to be useful as a discussion device, and in part to just find out
whether you'd be interested in more on this, or whether it is, in
fact, too complex or different to go on with.

          But, it does require that an IRB look and review the
information and that the FDA endorse this use under military
exigencies.

          CHAIR FADEN:  I think what we should do is table it for
now.  Maybe we can come up with something that's a longer, but
not -- obviously, I think the little bit I know, Jay's
characterization is right, this is incredibly complicated, but on
the other hand it does bear on what we are doing.  So, we'll get
a more detailed write-up and then make available to any committee
members, you know, the information that is available, the raw
dockets as it were, so that people can read as deeply into this
as they would like.  So, we'll have your job be not to do the
most detailed treatment, but to do a more detailed treatment and
then provide to any committee member who wants the basic
documents currently available.

          DR. KATZ:  Hopefully, Ruth, that some of the
recommendations we've made will meet problems that the Desert
Shield studies raise will make them no longer possible.  There
was confusion and it was never completely -- it's very hard to
get to the bottom of it, to what extent was -- it was treatment,
and they really had the best interests of the soldiers in mind,
but what was the research component in all this?

          And, it's been very, very -- there was a research
component in there, not so much prospectively, but
retrospectively.  And, how this -- and again, you know, since we
have some concern, you know, about the interplay of treatment and
research, you know --

          DR. RUSSELL:  I think you'll find that the research
that was done basically was surveys of symptoms and so forth was
done under informed consent rules.

          DR. KATZ:  But, it's after the fact, you know.

          DR. RUSSELL:  After the fact.

          CHAIR FADEN:  There obviously is an interest.  We will
provide more information and then we'll make a judgment about how
far to go with this.  But, it's of relevance because it has some
of the similar tensions to some of the other things that we are
looking at.

          Could I take, in the time that we've got, we have a
little bit more time left, Wilhelmine, could you just summarize
for us, I know you've done it in the report, the status of your
findings with respect to the current situation concerning
classified research?

          MS. MILLER:  Sure.

          I guess the first --

          CHAIR FADEN:  Human research.

          MS. MILLER:  -- yes, the first major point to make is
that classified research under the common federal rule which
applies in 16 agencies comes under exactly the same set of
procedural requirements for -- human subject's protection is
unclassified research, so every agency said there would be
absolutely no difference in the way in which such research would
be reviewed by an IRB, although, in some cases the IRB would have
to meet under secure circumstances and basically have security
cleared members, which may pose a problem for a community member,
unless it were anticipated well in advance that this IRB would
review a lot of classified work.

          There seems to be virtually no classified research
involving human subjects going on today, at least so it has been
reported by -- it's summarized in each section by DOD, by
Department of Energy.  The CIA says it does a very small one, or
two, or three number of research projects a year that involve
human subjects, that they are able to inform the human subjects
of the nature of the research and the sponsorship of the CIA. 
NASA says it's never done human -- classified human subjects
research.  The agencies that have classification authority are
DOD, NASA, DOE, Department of Defense, CIA, not the VA, and I
don't believe HHS, although there are security cleared personnel
in FDA who work with DOD on the very issue of, you know,
investigational products that may be used in military situations. 
So, the universe has shrunk.

          Lois.

          MS. NORRIS:  I just have a quick question.  You
mentioned with respect to the CIA sponsored research that the
subjects are informed that the CIA is, in fact, sponsoring the
research.  Is there a requirement for that funding source
disclosure, or is it because it is, in fact, the CIA?

          MS. MILLER:  No.  I think it's just under the general
principle and spirit of informed consent that a subject should be
told to be fully informed of the nature of the research in which
they are participating.  It's not a particularly -- you know,
it's not particular to the CIA.

          MS. NORRIS:  Do you think that's commonly done,
generally, I mean the funding source is commonly disclosed to
research subjects in informed consents?

          MS. MILLER:  I don't know that -- I mean, I haven't
seen it in the samples I've looked at, but maybe I haven't been
looking for it, that is, that this is an NIH-sponsored study. 
Maybe others of you know better if this comes up.

          MS. NORRIS:  I see it in them sometimes with respect to
compensation in cases, injury types of clauses, where you have
drug companies funding disclosure, but I don't see it as a
separate item, saying this is funded by.

          MS. MILLER:  No, it's not a requirement of the common
rule specifically that the funding source be disclosed.

          CHAIR FADEN:  Wilhelmine, are we understanding you
correctly to say then that as far as the common rule is
concerned, if there is classified research there's a provision
that permits it, but classified research is not -- there's no
exemption with respect to informed consent requirements?

          MS. MILLER:  That's right.

          CHAIR FADEN:  For classified research. So, presumably,
this classified research has to be done in such a way that
subjects can be told everything as the subject would be told that
the research is not classified.  Nothing can be withheld.

          MS. MILLER:  That's true, unless the Secretary or
agency head waiver is invoked of any of those provisions, but
then there are two other requirements which come into play, one
that, if any of the provisions of the common rule, which include
IRB review and informed consent, are to be waived or modified,
that the Office for the Protection From Research Risks is to be
notified of the waiver and a Federal Register announcement is
supposed to be placed announcing the waiver, which is almost
inherently a conflictual situation for classified research.

          CHAIR FADEN:  Right.

          MS. MILLER:  So, I don't think that's really something
that's been addressed.

          CHAIR FADEN:  So, if we think the Department of Defense
or the Department of Energy wanted to do classified research that
required withholding the purpose to make it coherent, you needed
a waiver from some or all or part of the provisions requiring
informed consent, they would have to notify OPRR and HHS, even
though they are the DOD.

          MS. MILLER:  Right.

          CHAIR FADEN:  And then, they'd have to put it in the
Federal Register, a notice that we're doing classified research
and we're waiving requirements.  Okay.

          MS. MILLER:  I don't think these two requirements were
thought through together necessarily, the possibility of
classified research and the opportunity for the Secretary to
waive, so it's just one of those --

          MR. GUTTMAN:  One of the questions we are discussing is
exactly what it is that -- we had a meeting with the CIA, and
they said well, we're doing polygraph stuff, so we're telling
people it's to find out how polygraph worked.  Well, does the
subject then get to say, well, why exactly do you want to know.

          You know, Wilhelmine, you talk about your dialogue with
the agencies about, we tell them everything they have to know,
but we won't tell them something that's classified.  In other
words, the question is, what if there is a secret purpose, which
there obviously is if it's -- there may well be, but,
nonetheless, you are disclosing something that -- that balance on
how you try to --

          MS. MILLER:  I don't know that I have a clear answer. 
I mean, it came up in discussion with the Department of Energy
staff, that there might be some classified research which bore
some relationship to human subject research, which was not
classified.  And, exactly what the nature of that relationship
is, I can't enlighten you on.

          It has to do with what the IRB approves as a fully
adequate informed consent document.  And, presumably, if the
research -- any aspect of it is classified, and the IRB is a
security-cleared IRB, then they make the judgment as to what in
the informed consent document constitutes a full disclosure.

          CHAIR FADEN:  Ruth.

          MS. MACKLIN:  I would have thought that this goes right
under the IRB waiver provision in the common rule.  An IRB may
approve a consent procedure which does not include or which
alters some or all of the elements of informed consent set forth
in this section, blah, blah, blah, provided that the IRB finds
and documents that.  And, the first item is research involves no
more than minimal risk to the subjects, and certainly polygraph
research, you can argue, would be no more than minimal research -
-

          MS. MILLER:  Right.

          MS. MACKLIN:  -- and then it goes on and number three
is the key element here, the research could not practicably be
carried out without the waiver or alteration.  It seems to me
that's the escape hatch that can allow many things to go through.

          MS. MILLER:  My understanding of that is that it was
for psychologically deceptive research, but I didn't even check
into that.

          MS. MACKLIN:  Well, I know that's what it's supposed to
be for, because that's -- the research could not practicably be
carried out without the waiver or alteration is the deceptive
research which then you do "debriefing" afterwards, right?

          But, it seems to me, a clause like this, it may have
been put in there for that purpose, but if you try to interpret
what it means, if it could not practicably be carried out without
the waiver the example of something that has some secret -- some
classified elements in it that could not practicably be carried
out would seem to cover this.

          MS. MILLER:  That's an opening I didn't anticipate. 
You are right.

          CHAIR FADEN:  Are you suggesting, Ruth, that you would
-- the Secretary would need to go --

          MS. MACKLIN:  Not need, no, would not need to.

          CHAIR FADEN:  -- could work it with -- as long as the
claim -- as long as the IRB could claim it was less than minimal
risk.

          MS. MACKLIN:  Yes.

          MR. GUTTMAN:  I can't believe you'd disclose on the
public record this classified interpretation of that.

          CHAIR FADEN:  He's teasing.

          MR. GUTTMAN:  With a previously secret loophole.

          CHAIR FADEN:  Why are we telling people this is an
issue, if they didn't know already, why do we have to tip them
off.

          In line with this, our reading is correct that right
now, with the exception of the CIA, no agency has told you that
it currently is conducting research involving human subjects that
is classified.

          MS. MILLER:  That's right.

          CHAIR FADEN:  With the exception of the CIA, and the
DOE has said that they have a few projects that link to
classified research.

          MS. MILLER:  Actually, it was DOE.

          CHAIR FADEN:  Right, but your question was generally or
with respect to radiation?

          MS. MILLER:  It was only generally, I did this
generally.

          CHAIR FADEN:  Yes.

          MS. MILLER:  I have not really limited the discussions
with the agencies on this to radiation experimentation.

          CHAIR FADEN:  So, the current perception would be there
is very little except for the CIA, or maybe none except for the
CIA classified research involving human subjects currently
ongoing.

          To me, you are asking for right now.  I wonder if we
could get a sense of in the past five years, so we can know
whether this is an anomalous year because of the attention
currently being paid to research involving human subjects,
particularly research that has a history of secrecy and
classification or not.

          MS. MILLER:  Okay.

          CHAIR FADEN:  Henry.

          DR. ROYAL:  Would it be possible to get an example of
some of the research that was classified that maybe is going to
declassify, so we could get somebody to deal with what kinds of
things they might have done and how they might be done
differently?

          CHAIR FADEN:  How they were approved too, exactly what
happened.

          MR. GUTTMAN:  In the contemporary period?

          CHAIR FADEN:  Yes, that would be very helpful.

          DR. ROYAL:  The last one that they did in each agency
or something.

          MS. MILLER:  Okay.

          CHAIR FADEN:  And, if it's still classified, we could
have some classified -- some committee members and staff with
security clearances take a look.

          MS. MILLER:  Okay.

          CHAIR FADEN:  Again, to look at -- we have a sense that
they are being done and handled that way.  We can certainly do
that.

          Lois.

          MS. NORRIS:  This is back to Ruth's discussion with
respect to the exception on the research which you note is a new
loophole or a newly pointed out loophole.  The debriefing is not
a regulatory requirement of it either, is it?  I mean, that's
purely IRB -- that's what I thought.

          MS. MACKLIN:  It's the way the research designer,
that's in order to justify to the IRB, listen, we're going to
withhold this from them, but don't worry, don't worry.

          MS. NORRIS:  I've seen that, but I just wanted to make
sure that you knew that it's not required.

          CHAIR FADEN:  Your point is there is no obligation to
disclose who the funding agency is and no obligation to debrief. 
They seem to be self-composed.

          Okay.  This is actually the first of many looks at the
contemporary situation, and this is to get us on the road of
thinking about the kinds of forward looking recommendations we
would like to make.

          So, are there other questions for Wilhelmine to direct
what other work she should be doing beyond what's already been
discussed?

          Okay.  Then, thank you very much.  This is a great
start, and we are taking our lunch break and resuming at 1:30,
1:45.  It's realistic, we are going to say 1:30, we are going to
start at 1:45.

          (Whereupon, the meeting was recessed at 12:22 p.m., to
reconvene at 1:45 p.m., this same day.)















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

                                                                  1:50 P.M.

          CHAIR FADEN:  Let me clarify something that was said in
the discussion just before the break about the conduct of
classified research by the CIA.  I think we may not have gotten
the story quite right.  We don't know.  Apparently the correct
understanding, from what we've been told by the CIA, is that they
do a handful of human research projects, or perhaps less, a year. 
One, two, three, four, five.  Something like that.  Sometimes
none of them are classified.  Sometimes one or two may be.  We
don't know precisely whether at this moment they have a
classified human subjects research project ongoing so the
information may have sounded other than that in the discussion
before lunch.

          Also in line with that, when we were talking about the
CIA's disclosing to subjects in its classified research that
indeed this is CIA-funded research, that's not entirely true
either that research subjects are necessarily always told that
the funding source for this research project is the CIA.  So
we're going to get that down and straight for us all by the next
meeting, get the information as accurately as we can for you.

          Okay.  We're now onto our next agenda item which is a
continuation in many respects of the discussion that we've been
having over the past two days, looking in particular at the
context of the total body irradiation programs of research that
were conducted during the period of interest to us.  What I have
suggested that we do in informal conversations with committee
members and staff over the lunch break, everybody seems to
understand what we're going to try to do is we're going to try to
see the extent to which information is available to the committee
of the sort that would allow the  committee members to make
judgments about the culpability of either people in individual
roles or individual persons, and that would include both people
in roles or named individual in bureaucratic-type relationships
to these TBI studies, that is DOD personnel in the various
contexts that had to do with funding or oversight of the
research, as well as investigators who conducted the research.  

          The idea here is we will ask staff and, in particular,
the staff we have with us -- we're fortunate to have Gary Stern
and Ron Neumann with us.  We will ask Gary and Ron questions, the
answers to which we would like to have in order in our own minds
to begin to see if we have the kind of information that would
allow us to make any kind of judgments about individuals.  We
have been saying, end of day yesterday and this morning, that
evidentiary problems may be very major problems in our being able
to make judgments about the culpability of identifiable
individuals or named persons or even perhaps people in particular
roles.  But we don't want to make that claim without testing it
in some of the contexts of some particular cases, so let's start
that process now by saying how much information do we have that
bears on questions of individual culpability without necessarily
reaching a collective judgment at this point.  

          So is everybody clear on what we're going to do?  I
hope that all of us have been thinking of questions that we would
like the answers to and then Ron and Gary will tell us the extent
to which we have answers and how good the evidence is for those
answers so that we can start to think in the context of these
specific concrete cases.

          Before we start, I can't remember.  Gary and Ron, do
you remember which committee meeting you made the last
presentation on TBI?

          MR. STERN:  I believe it was the November meeting.

          CHAIR FADEN:  The November meeting.  So what Ron and
Gary are going to do is give us a quick update on whatever new or
additional information about the TBI experiments that they have
that we don't all have and then we'll start.

          DR. NEUMANN:  As a means to set the historical context
for the broad program of TBI research that went on from '44 to
'72, we've structured our discussion in terms of eras, the first
being the TBI experiments during the actual war predominantly
done in Chicago which included three normal laboratory workers. 
There the driving needs seem to have been information regarding
radiation exposure because workers were obviously now being
exposed in producing the bomb.  

          After the war, the nuclear-powered aircraft proposal
again emphasized the need to have a better understanding of human
performance and tolerance for radiation exposure.  As you recall,
that was to be a nuclear-powered bomber and the concern was with
the shielding that was engineeringly and physically possible, the
pilot and crew would receive a radiation dose on any mission and
the military needed to know whether or not they could not only
perform that mission but could they tell the pilots that they
wouldn't have, for example, genetic problems in their children
and so forth?  That was the second phase of information that
drove the funding of that type of TBI research.

          The third is sort of a blend in which we pick up, for
example, the Cincinnati experiments.  The need is for a biologic
dosimeter by which one could actually measure exposed individuals
after the fact had they not been bashed with films or other types
of personal dosimeters.  So the driving need was to find some
biological marker that you might assay in blood or urine or skin
biopsy or something that would tell you reasonably and
effectively how much irradiation a soldier might have received on
a nuclear battlefield and whether or not individuals at various
exposure levels could continue to carry out their functions.

          The final phase begins which NASA is concerned about
the astronauts and their ability to tolerate the radiation that
they might or might not receive during flights outside the
earth's atmosphere.           So those general needs drove the
federal government's funding of TBI research and the most
interesting phase that I think we've explored in greater detail
since our last meeting is the relationship between this NEPA need
for the nuclear powered aircraft pilot tolerance measurements and
the discussions that went on in a medical advisory committee
assigned to the NEPA project.  You've read much of that material. 
There were nine subcommittees that met.  

          The first task the group did was actually make a --
like all good scientists -- list of the known knowledge about
radiation exposure and what the biological, medical and
psychological consequences were and they produced that table as
part of their first task after meeting in Chicago.  They
discussed that and decided there needed to be additional
information and Dr. Stone became the chairperson of a human
experiment subcommittee.  In the material we've presented to you
he argues very forcefully that experiments need to be done on
human beings because the material and knowledge they had at that
point highlighted the variability of human responses to radiation
exposure, and he argues moreover that the data that had been
gathered by medical irradiation of patients was not sufficient
and that fundamentally a patient with an underlying disease, be
it a malignancy or a benign disease like arthritis, was different
enough from a quote "normal" young male in particular that the
data that they had accumulated was not accurate enough and could
not be used successfully to answer the types of military
questions that were being asked.  So he argues forcefully in his
writing to allow experimental programs to be set up to irradiate
normal volunteers and he includes prisoners in that.

          He also argued very, very eloquently for using the
criteria of Nuremberg and others that were available to him at
that time and that no experiments be done without full informed
consent.  That's in some of the writings that we've furnished.  

          The request to do the normal human experimentation with
TBI was refused.  We haven't pinpointed exactly what level.  We
believe it was involvement with the Atomic Energy Commission's
medical groups and there's suggestion that it was made at the
level of Shields Warren who says that no, he doesn't think
further experimentation is going to be acceptable to the public
for various reasons.  

          After that we find then that in fact the Air Force
contracts for the first TBI post-war study in Texas and we begin
the post-war era of TBI research with the irradiation of cancer
patients and studying the effects of that irradiation.  

          The difficulty that one encounters comes right back, I
think, to Stone's argument that at the end of the entire program
in '72 the data that was obtained was not all that much
different.  If you compare those tables with the tables that this
NEPA advisory committee produced, the various radiation exposure
levels and the biological effects don't look all that much
different from what we accept right now in the modern era.  So it
would suggest to me that for a number of reasons the 20- or 25-
year research program on TBI fundamentally didn't change or
enhance the knowledge that was available in the early 1950s when
the committee met for the first time to just assemble current
knowledge.

          The unstated problem in using the hospital patients is
this one of variability that Stone points to.  Statistically, one
of the ways to best deal with variability is to enlarge the
sample size to minimize the effect of individual variability. 
And we've not found evidence that anyone actually designed the
large number of patient trials with that in mind but it may have
been in the minds of those people who were responsible for
analyzing the data that in fact they had to keep going forward
with irradiation studies of this sort in a hope to minimize
variability and come up with some standards and numbers that they
had marked degree of confidence in.

          With that, I'll let Gary just brief you on some of the
individual documents that have led to these conclusions.

          MR. STERN:  We have prepared a handout that you should
have with several attachments that was circulated yesterday, I
believe, and I think it's perhaps most useful and instructive to
look at the correspondence between Dr. Alan Gregg, who is the
Chairman of the Advisory Committee on Biology in Medicine at the
AEC, and Dr. Stone in 1948.  This is material that we did pass
around last summer but it wasn't until, at least for myself
having reviewed the TBI stuff in much more detail, that what Dr.
Gregg had to say in particular really stood out and so it's
quoted on the first two pages of the handout.  But the concerns
that Dr. Gregg raised, I think, are relevant and play directly
into an analysis of any of the subsequent TBI studies that were
done or in fact any dual purpose type of research that's done
certainly with agencies like the DOD and the AEC because the
first point that he makes in the first sentence at the bottom of
page 1 is that, as he says, "The secrecy with which the work of
the AEC has to be conducted creates special conditions for the
clinical aspects of its work in that the public is aware of this
necessity for secrecy and of the consequent difficulty of probing
into it."           Essentially he's saying that the AEC has a
higher burden to review the work of its contractors, the medical
work of its contractors, because of the secret nature of the work
that it's doing and the appearance of a concern that it could
have on the treatment of patients as well as the reality that it
is, when you're involved in secret research or secret ends for
which the research is being conducted, that oversight can be less
thorough.  And so Gregg is saying that we have to be all the more
thorough in reviewing this work, and he's doing this in the
context of criticism of one of those three TBI studies that were
done during the Manhattan Project.  It was actually the one done
by Dr. Stone at the University of California Hospital in which
they irradiated arthritis patients and in 1948 there was, I
think, a majority view at the AEC that that was not good medicine
and that they were very concerned about that and, as it's quoted
above, "There's an agreement at the ACBM that xray treatment for
arthritic patients that you've been giving is not justified."  

          Finally, Gregg raises this further problem as he
describes it that "There is plenty of experience that shows that
some forms of therapy that attract enthusiastic supporters
ultimately are discarded later as unsafe or unjustified" and so
they have to again be extra careful to make sure that just
because there may be even a fairly wide interest and belief in
certain types of therapy that those could pose dangers that we
have to be on the look out for.  He concedes, of course, it can
go the other way, that agencies or reviewers can be reticent
about a certain type of therapy that ultimately turns out to be
useful.  

          But the concerns that he raises here I think we see
come into play farther down the line where you have both
Department of Defense engaged in military and national security
and secret activities, funding medical research maybe without
paying the type of regard that Gregg is suggesting to the work of
their researchers and that possibly you have, as indications seem
to be, that you have treatment by those researchers for the DOD
of types of cancers for which the TBI ultimately seems to have
been seen not to be the best type of therapy.

          So that I think sets a framework in which to better
analyze the subsequent work that was done and funded by the DOD. 
I think I'll just leave it there.

          CHAIR FADEN:  The floor is open.  We have a range of
TBI experiments, so we can zero in on the same experiments is
what we'd like to do.  Again, the exercise -- exercise is perhaps
not a good term -- the task the committee is undergoing is to ask
questions, the answers to which we think would help us
individually and then ultimately collectively and any effort to
try to address questions of culpability to specific individuals
and I would like us to range from not only to focus on the
individual investigators but also the government officials as
well who approved and sponsored the research.  

          With that, it's open.  Nancy.

          DR. OLEINICK:  I think the outline here is very useful. 
I guess one of the points that comes across is that these
experiments ranged over an almost 30 year period, something less
than 30 years, and at the end of the day there wasn't much more
information than at the beginning of the day.  So the natural
question is, who was charged along the way with reviewing these
experiments, reviewing the literature, as it were, up to that
time to ask, how much more experimentation do we need, assuming
that the questions were still valid, and how much can we
reasonably expect of these experiments?  How much new information
do we think we can get?  How many patients would have to be
treated to give us an improvement in the data?  

          That's a statistical question but the previous, the
prior question to the statistical one is, at any particular time
when a new set of investigators was going to charge into this
field how much was already known and was there a need for
additional information?  What I don't see too much along the way
is that background for each new set of experiments.

          CHAIR FADEN:  Ron.

          DR. NEUMANN:  You're absolutely right.  As far as we
can tell, no one was in charge of the overall project.  One of
you raised the issue this morning about advisory committees and
throughout the 30 years it's a series of different advisory
committees, as best I can interpret it, who are called together
by a potential funding group within the federal government to ask
advice on how to best get a grip on this problem.  

          In each instance, beginning, for example, with the NEPA
Project, they collected all the known literature.  The NEPA early
report is extraordinary in documenting the extent of knowledge in
1949 or '50, whenever they put that together.  Whether or not
that was passed along to each investigator is also an interesting
question.  We asked that of Dr. Saenger in our interview to him. 
Was he furnished with all the background information prior to
beginning his contract?  As I recall his answer, it was that he
was not.  He was aware of what was in the literature.  And I
should highlight that the bulk of this was not classified.  These
people did publish at least the medical aspects of the TBI
research as they went along so that it was probably available to
a sophisticated investigator who did a literature review, as we
all do when we do good science.  

          The interpretation of the literature I guess is where
Dr. Saenger might differ from others.  His interpretation, as
he's stated, at the time he began is that there was some hope for
TBI in treatment of solid tumors.  Others who reviewed his work
later suggested that wasn't the case.  We don't, I think, today
have a system other than peer review that makes such a decision
as to how one interprets the literature.  As you're aware, with
the help of the National Library of Medicine, we're attempting to
put together a complete bibliography of all the literature on TBI
and I must say in reading those, like all science papers even
written now, at the end when there's a very obvious negative
effect, you get a conclusion statement that suggests more
research is needed because there's some glimmer of hope here or
words to that effect because very few of us will publish negative
papers saying, this technique was worthless and please don't
anyone else try it again.          That's a problem with the way
we write literature.  Journals, we're all aware, need to accept
negative articles to put an end to research that shouldn't be
continued.  That didn't happen and in reading the types of
publications about TBI, it's very rare to have someone come out
and say dramatically, don't do this again because it doesn't
work.  They'll present the results and you're left to your own
interpretation.

          So Dr. Saenger concluded that there was hope and that
it was, in his words I think, equivalent to the primitive form of
chemotherapy that was available at the time.  Others interpreted
the same literature presumably.

          The oversight centrally changed across funding groups
and, more importantly, the medical officers or military officers
involved, I'm sure, rotated duty stations.  I have no evidence
and I think we've found nothing to suggest anyone was overlooking
all of the data and that each time a new contract was let that
they gave all existing data in some package form to a new
investigator.  

          They also seem not to have central statistical
analysis.  There's no evidence that anyone took these things and
tried to do statistical analysis of what they knew along the way
at any point in time.  Each investigator did more or less what
they thought was a statistical analysis to a greater or lesser
degree of accuracy, and Duncan has made his comment previously on
at least Dr. Saenger's paper.  But I think it's safe to say in
general no one was in charge and with the exception of the NEPA
Committee summary, there wasn't a formal process where they
accumulated all the data and looked at it repetitively and said,
do we need to keep doing these types of experiments?

          MR. STERN:  Let me just add that I think one problem
you have is essentially there are four different agencies doing
the same thing which were not necessarily interactive with one
other, the three being the different military services.  You have
the Air Force, the Army and the Navy each essentially doing
similar research and then you have the AEC as well.  

          On the other hand, I think it was a small enough
community that even by the end, Dr. Saenger, even if he wasn't
formally presented with the findings of everyone else, he was
familiar with what was going on at Baylor, at Sloan Kettering,
even at M.D. Anderson.  He had familiarity with that.  

          The other thing is that the indication we get from
reading the review documents of the Saenger proposal was that the
reviewers seemed to essentially rely on their view of the quality
and the qualifications of the researcher.  It's been quoted
several times, at least one reviewer of the Saenger proposal says
quite explicitly, well, he doesn't expect this to be successful. 
In fact, all indications suggest that the protocol they're
reviewing will not be successful but we should do it anyway
because we want to hire someone who's a researcher of any kind in
this area.  There are so few, we want to keep them on stock, on
store for future research.  So there's some piece of that going
on.

          And then finally you do get in the AEC in 1966, at
least towards the end, a sense from the Oak Ridge researchers
themselves that at least for treatment of what are called then
radio-resistant tumors, they did not think -- the suggestion was
made to them and they come back and say, no, that in fact would
be unethical because it couldn't be done in any good scientific
manner.

          CHAIR FADEN:  Henry.

          MR. HENRY:  There are a lot of complicated issues.  The
issue that I would like to address at the moment is whether or
not a reasonable truly informed person at the time might have
consented to whole body irradiation.  So my question is, given
what you know about what was known about whole body treatment at
the time that Saenger was doing his experiments, given what you
know about what the alternative treatments were, would a
reasonable person agree to having a whole body irradiation being
fully informed of the facts even though there might be only a
slight chance that it would help?

          DR. NEUMANN:  I think dying patients have different
acceptance of risk and certainly degree of comfort with entering
into experimental protocols but there are individuals who are
desperate to try anything and it's not inconceivable to me that I
myself, were I a patient and had a terminal solid malignancy and
adenocarcinoma of the lung, for example, would have accepted that
protocol had it been explained to me and had I been asked to give
consent.            The only caveat I think that I would attach
to that, it's very rare for us, even now, to give a literature
list, for example, to a patient to make their own interpretation
of the literature.  As a professional, it's hard for me to know
whether in that informed consent process one's personal
interpretation of the literature is sufficient or how to
adequately present the literature extent to that point in a time
in a fair manner so that the person has a reasonable
understanding of that percent hope of an experimental treatment.

          The literature at this point would suggest there was
strong evidence that it did not work particularly well for solid
tumors.  Now if that was honestly and openly told to the
individual and they still decided to take that risk because after
all, chemotherapy had no real cure for solid tumors in 1960
either, then I think the answer to your question is yes, an
informed person might have accepted that they wanted to do
something and even though it had no individual benefit to them,
that the idea of furthering medical knowledge was an acceptable
risk they would take.

          MR. HENRY:  You framed your answer in the context of a
dying person.  What about some of the other patients that were
not terminal patients?

          DR. NEUMANN:  I think it's the same thing, Duncan. 
There are individuals who will take extreme risks.  I personally,
if you asked me if I had arthritis, would I accept irradiation, I
mean again probably not, but that's based on my knowledge now,
not being a layperson in 1960.  There are individuals that will
subject themselves to extraordinary things today at NIH that I
would never in my right mind do. I mean I wouldn't have a
ventricular catheter put in my heart, but there are normal people
who do that.  You've heard that.  We've all reviewed protocols
like that.  

          So I think it all pivots on the information that was
presented to the individual who was asked to participate.  If
that was accurate, open and honest and the individual accepted, I
think there's not a problem with the experiments.  As I
understand, the bulk of the legal questions right now at
Cincinnati are based on that content of the informed consent
statement.

          CHAIR FADEN:  I've got a list building, so let me just
--

          MR. STERN:  If I could just continue the answer to the
question to make two more points.

          CHAIR FADEN:  Quickly.

          MR. STERN:  Very quickly.  One is that another
rationale for accepting treatment that was proffered actually by
Dr. Saenger was that he said that some patients were willing to
do it purely for the advancement of science, even without any
expectation of their own health.  So that could be a rationale. 
Some people think, well, if they are going to die in some
specific short period of time, they're willing to do it even with
no expectation of health.          I do think though that the
answer is premised on what they are told and certainly the
evidence seems to indicate that in terms of the specific risk of
death from the high dose of radiation caused by bone marrow
suppression in the 20 to 60 day period which the reviewers in
1966 were saying was a one in four chance, that that risk was
never told to the patient so that has to frame a consideration
that if they were told there is a one in four chance that they
could die from this level of dose -- I don't believe that they
were.

          DR. NEUMANN:  It wasn't in the written documents that
we have.  If it was said verbally, we have --

          DR. THOMAS:  What does Dr. Saenger say?  Does Dr.
Saenger say that he told them that there was a one in four
chance?

          DR. NEUMANN:  You might recall, he did not ever
directly approach the patient.  He purposely had a different
medical person approach the individual and explain that.

          MR. STERN:  Actually we did ask them whether the risk
of death as proposed by Dr. Shields, one of the other reviewers
who said that they should as part of informed consent say there's
a one in four chance of death.  We in the second interview asked
them, did they warn patients, inform them of that risk of death? 
I believe he basically said no and sort of described that, well,
it's very difficult to know what the risk of death is and that's
a difficult question and that's what people are still groping
with how, in fact, what you say, what is the risk of death.  He
wasn't clear that that was correct, that there was a one in four. 


          So although he personally was not addressing patients,
my sense is that it wasn't said, in part because maybe there
wasn't a consensus that that was what the risk was.

          DR. NEUMANN:  And even in that committee,  I mean that
was one reviewer's opinion.  To be fair to Dr. Saenger, we don't
have evidence that the committee instructed him to tell patients
that.  That was one reviewer's comment.

          MR. STERN:  Right.  In fact, that was his
recommendation.  The committee did not adopt that recommendation
that they tell patients there is a one in four chance of death.

          CHAIR FADEN:  I've got Mary Ann, Duncan, Eli and then
I'm going to put myself on the list because otherwise I'll never
get in.  Mary Ann.

          DR. STEVENSON:  Sort of picking up on what other people
have said, but I think there are two issues or could be two
issues that we address, and we could spend a lot of time arguing
about whether TBI was at that time a valid treatment modality. 
I'm not sure that's particularly fruitful.  Speaking maybe toward
it being perhaps considered a valid treatment modality is with
the exception, I think, of the University of Cincinnati, the
other hospitals that eventually contracted for short periods of
time with DOD in fact had ongoing TBI programs separate from the
DOD contract.  So there must have been some interest in parts of
the medical community that there was reason to pursue TBI at some
point.

          DR. NEUMANN:  Certainly for leukemias and lymphomas,
that's true, and many of the patients treated at those
institutions had those types of malignancies.  The thing that
stands out in the Cincinnati patient population is that with the
exception of I think it was three Ewings patients, the bulk of
those patients are solid tumor patients which is a little
different.

          DR. STEVENSON:  Right, and then there's the exception
which is City of Hope which did a non-Dod-sponsored study on TBI
of solid tumors.  But that aside, I think we'll spend a lot of
time and maybe not get anywhere if we concentrate on the medical
validity of TBI.  But rather I think the second much more
important issue is the obligation of an individual investigator
or university or government agency to ensure that the patients
are fully informed of the risks and benefits of the treatment,
whether it be TBI or any other treatment as far as that goes.  

          What I'm finding most amazing looking through these
documents --  and we've spent most of the time on the University
of Cincinnati because we have more information about that -- is
the real failure of the review process at a number of occasions
to address and enforce that issue.  As Ron pointed out, these
were really done in a fairly public arena.  I mean the papers
were published, the fact that the review committee was, in
essence -- not entirely public but it wasn't a secret committee. 
And real strong objections were raised at a number of occasions
including the DOD.  I mean I'm sort of amazed at the DOD review 
when they actually state in writing that they think there's very
little chance that this kind of study will yield that much but
maybe eventually some other bent will be taken and some
information will be gained.  I mean this would be totally
unacceptable in peer review processes now.  You wouldn't get
funded just on the chance that maybe some day you'll find
something interesting.  

          So what strikes me is that the public or relatively
public review process failed miserably even though there was
something in place.  In the faculty review committee the same. 
The request that the chance of one in four deaths be included on
the consent was never addressed.  The proposal and the consent
forms went through multiple iterations but somehow they were
given provisional permission to continue and, in fact, the only
stop was at the NIH where the NIH twice -- well, actually three
times but twice rejected the grant on moral or ethical grounds,
sent it back to the University of Cincinnati but yet the
University of Cincinnati did not in turn stop it at the
university level.  I find that very surprising and interesting
because if the NIH approached me as a university official and
said, these grants are entirely unacceptable on medical or
ethical grounds, I think I'd be very concerned.  But yet those
studies went on for a good two or three years until it reached
sort of public media level at which point the university called
it quits.

          DR. NEUMANN:  Yes.  One of the issues that has served
both sides in the debate over the years about this is the
contention that in fact the radiation was not part of the
government-sponsored research.  If you recall, they funded -- if
we take Dr. Saenger's example, they funded him to study body
fluids for biological dosimeter and do psychological testing of
performance.  Their defense early in the process of review in the
'70s was that they did not fund him to radiate the patients, that
this was being done for medical purposes.  They did not see it
their role to intervene in that and that since the radiation was
done, they were taking advantage of the fact that their research
for the biologic dosimeter could be done in those individuals
after the fact, so to speak.            Of course, when you
debate the entire thing, and we've asked Dr. Saenger, Gary asked
Dr. Saenger, could you have done this work without the money? 
And he sort of says in essence, no.  So it becomes one of these
arguments again that I think you individually have to decide
whether or not these people were irradiated for the military
experiment purpose or whether in fact he had in his mind a
therapeutic purpose for the irradiation and was accepting the
government funding to allow him to do that which is again still
done today, because otherwise he wouldn't have been able to carry
out his therapeutically intended project.

          The difficulty that I have with that argument is the
lack of protocol, etcetera, that we discussed previously for the
medical therapy part.  I mean that, in my mind, I called it bad
science because he could not produce the types of things that I
look for in what I consider a good science project.  And part of
it, as Henry has pointed out, is the lack of documentary evidence
after a number of years should not perhaps be the only standard
by which we judge that.  

          Again, mixing, as I've said over and over, an
experiment or piggybacking experiments like this I think puts one
in very, very dangerous circumstances on occasion because you
have divergent endpoints, probably divergent ways that you ought
to carry out such experiments and to try to mix them in essence
often produces bad data or non-useful data or no data and puts
one at great risk of entering a quagmire in terms of
retrospective judgment.

          CHAIR FADEN:  Duncan.  

          DR. THOMAS:  I want to return to Ron's comment of a
little while earlier that even today it's unusual to provide the
reports back to the patient with the unfiltered literature that
we always interpret for them.  It's my understanding that there's
nothing in the Common Rule which requires that we provide
patients with the literature and probably conclude that most
patients wouldn't know what to do with it if we did provide it to
them.  Instead, the statements of risks and benefits need to be
made explicitly in the consent form and that we rely on the IRB
to be a form of peer review for the validity of the information
that we're providing them, at least in print.  

          Of course, in addition the investigators will go ahead
and make their own interpretation and explain to the patient what
all this stuff means and we have no real control over what
happens in that interaction.  

          So that suggests to me that our problem with the TBI
experiments perhaps may not be so much in our lack of confidence
in what the investigator may have tried to communicate to the
patients but the absence of any sort of system in terms of
oversight to provide any sort of peer review for that
interpretation.  I just would like to hear your reactions to that
interpretation.

          DR. NEUMANN:  I think that's right.  It extends to the
point that I believe I made in November that according to Dr.
Saenger in fact, he received no instruction from the Department
of Defense at any point in his career about the rules for
carrying out clinical research nor any training and according to
both Dr. Saenger and his attorney in their extensive search of
his files and the hospital files presumably in preparation for
the various reviews that he's been through, they can find no
evidence of receiving any of the documents that the Department of
Defense claims it sent to contractors.  So not only was there not
scientific oversight, but at least in the Saenger case, if he is
to be believed, he was not given the documentary instruction that
was mandated following the Wilson memo and the '62 memo and all
the various other Army regulations that were detailed at great
length in the material you received from our historians and
ethicists.  

          CHAIR FADEN:  Eli.

          DR. GLATSTEIN:  Mary Ann asked most of what I was going
to focus on but I'd like to go back to just one other issue.  If
Dr. Saenger didn't talk to the patients directly, who did?

          DR. NEUMANN:  He had a series of co-investigators.  My
impression is that they were probably at the time junior faculty
members and/or residents and fellows.  They had cancer ward
rounds sort of where the physicians representing the various
specialties would discuss the cases and discuss potential, both
proven therapies as well as experimental therapies that were
available to these patients.  To paraphrase his words, I believe
his motives were to remove himself one step from the process for
reasons that we didn't ask him.

          DR. GLATSTEIN:  The process of patient selection.

          DR. NEUMANN:  Yes.  He entailed that task to these
junior associates.

          DR. GLATSTEIN:  How do they weigh the experimental
treatment compared to what at the time was probably the
alternative, either nothing or single agent chemotherapy?

          DR. NEUMANN:  They've been unable to talk to us based
upon attorney's recommendations.  I can guess -- I mean based
upon my experience, what I did, but we have been unable to ask
them those questions directly.  You're all aware there's a
pending lawsuit and they've all been named and they're all very
carefully being guided by attorneys in their meetings and
speaking to us at this point in time.

          DR. GLATSTEIN:  But Saenger himself agreed to talk with
you?

          DR. NEUMANN:  Yes, he did.

          MR. STERN:  Just to clarify, Dr. Saenger said that he
was very conscientious and careful to keep separate what he
understood to be the DOD portion of the study from the medical
clinical therapy, and that's why he didn't want to be there.  He
kept himself removed so he wouldn't influence the other doctors
who were both selecting patients and then selecting doses and
stuff, and that's how he explained it to us.  And then he said
that the choice of treatment of TBI and the doses were based on
basic medical practice at the time.  It wasn't part of, as least
he explained that it was not part of an experimental protocol. 
It was just what they deemed was the best treatment for those
patients at that time, in their view better than anything else.  

          CHAIR FADEN:  I wanted to pick up on two separate
things.  One, Ron, the line of argument with respect to the
Cincinnati investigators never receiving any documentation from
the Department of the Army.  I'd like to return to that in a
minute, but I wanted for just five minutes or less go to the TBI
experiments conducted during the war on the three normal patients
and could you rehearse for us very briefly how much information
we have either on who did this work and whether we know anything
about the conditions under which these three normal people were
subjected to total body irradiation.

          DR. NEUMANN:  I'll begin, and Gary probably has more
documentary evidence.  In essence, it was done at Chicago and I
think it was the Chicago Tumor Institute that had the machine
that was used.  These three were, as I understand it, laboratory
workers and I think they were in the Manhattan Project lab there
at Chicago, but I don't know that we know that for actual fact. 
As  I recall, they got 25 rads or something below that.  Seven
rads?

          MR. STERN:  They got 21 in three doses of seven.

          DR. NEUMANN:  Seven each.

          MR. STERN:  Actually, all we know is what was published
in an article describing the Chicago Study in the National
Nuclear Energy Series Volume and from recent documents that we
uncovered in which this particular experiment was the subject of
concern by the AEC on whether or not to declassify it because, as
we've talked about previously, the insurance people were
concerned that this would be bad PR and cause litigation
problems.  Stone was arguing for declassification of the study
and he said with respect to the three normals, so-called normals,
he said quote, "The healthy volunteers knew exactly what they
were doing and therefore do not become a matter of any dispute." 
That reiterates Ron's point that those three people were
apparently workers in the Met Lab, part of the Manhattan Project,
understood exactly how much they were going to be given and why. 
That's what Stone says so that's as much as we know about who
they were and what knowledge they had about what was going on.

          CHAIR FADEN:  And that really is it.

          DR. NEUMANN:  You asked who was in charge.  We think it
was Robert Stone who was in charge.

          CHAIR FADEN:  He was the investigator.

          DR. NEUMANN:  We don't know if these workers were from
his immediate group

          CHAIR FADEN:  But he seems to have had some
responsibility.

          MR. STERN:  He was head of the Health Division of the
Met Lab and he was the investigator in the other experiment at
the University of California on the arthritic patients.  I don't
believe he was the investigator of the Chicago Tumor Clinic one. 
That was written up by James Nickson and he describes two other
doctors from Chicago who were actually doing the therapy.  He was
overall reviewing the whole program.

          CHAIR FADEN:  Now I think we can return to the
Cincinnati experiments.  I want to see how clear we can get about
the arguments in favor and against you, the Wilson memo or the
1954 Army Surgeon General's circular version of it, and then
subsequently the 1962 #70-25 applied to Saenger and his
colleagues as contractors from the Department of the Army.  Could
we first clarify, did they receive their money from the R&D
Command?

          DR. NEUMANN:  No.  From the Defense Atomic Support
Agency, DASA, which is -- maybe someone wants to go through the
hierarchy but that was a group that was responsible for atomic
weapons effects analyses and they were apparently right off the
Deputy Secretary of Defense's office or something.  We have that
somewhere documented.

          MR. GUTTMAN:  DASA is what is today the Defense Nuclear
Agency.  As I recall, the application was to the Army Medical R&D
Command and I think DASA picked up the contract.  I'm not sure
what the particular reason was, whether it was the funding and
administrative arrangement, but it initially went into the Army
and becomes part of DNA predecessor's portfolio.  

          MR. STERN:  I think that's right.  The R&D Command
reviewed and approved the protocol and then sent it to DASA to
write up the contract and provide some money.

          MR. GUTTMAN:  To get to Ruth's question, I guess the
gist of the question of the question is that theoretically --

          MR. STERN:  It is an Army --

          MR. GUTTMAN:  Right.  If that was an Army regulation,
the Army were the ones that got the contract proposal when it
came in the door.

          MR. STERN:  I think that's right.

          DR. RUSSELL:  But the responsibility for adhering to
the regulations was the responsibility of the Contracting
Officer.  In this case, the Contracting Officer was in the
Department of Defense and would not be under AR70-25.

          MR. GUTTMAN:  This is before.

          DR. RUSSELL:  Or whatever direction was given.  When
that contract was turned over to the Department of Defense for
funding and management, the Army had no further control over it.

          DR. NEUMANN:  Interestingly, by the way, it's two Naval
officers who are named in the lawsuit in Cincinnati so they must
have been the ones rotating through DASA at the time to be the
Contracting Officer.

          DR. RUSSELL:  Staff assignments to DASA.

          CHAIR FADEN:  We will clarify that.  As I'm about to
say, in light of the discussion we had yesterday, we had the AEC
guidelines or policy as the ultimate backdrop.  We'll get the
technical nail down of it was a DASA contract.  Go ahead, Phil,
do you want to finish?

          DR. RUSSELL:  This is how things tend to slip through
cracks because the --

          CHAIR FADEN:  Right.  Good point.

          DR. RUSSELL:  -- responsibility for adherence to the
rules and regulations of the organization is the Contracting
Officer who gets technical support from the scientists or
whoever.  In this case, it went from a medical contracting
agency, was transferred over to a non-medical agency and so they
lost the staff capability for oversight.

          MR. GUTTMAN:  Can I ask a question though?  Phil, when
it came up to the initial reviewers, the ones that people have
been talking about and the one reviewer who said, even if it's
not great this time around, it'll be okay.  Would he have had an
obligation to know or ask whether the Army Surgeon General's
memo.

          DR. RUSSELL:  I don't know who those reviewers were,
whether they were staff people or whether they were external
reviewers.

          CHAIR FADEN:  In the context of the discussion this
morning, trying to figure out who was responsible for whatever
happened at the Department of the Army and the Department of
Defense, I'm trying to start there and then ultimately work up to
the investigators in Cincinnati.  If we retreat back and say,
okay, if it's DASA, at least the Wilson memo would have applied
because that was the whole department.  Right?  And so at very
least the DASA Contracting Officer, assuming he would have had
access to a classified memo, it would apply.  So the first
reading is, putting all this stuff aside, can you enlighten us as
to the arguments why the Wilson memo would apply to the work
done?

          DR. NEUMANN:  Well, it would seem to apply except to
the extent that I think the Department of Defense has argued they
were not contracting for anything harmful or potentially harmful
to be done to these individuals.  They were asking for a
collection and analysis of blood and urine specimens and later
psychological testing.  So I don't think that early in time we
have this concept being developed of minimal risk and whether,
for example, the Wilson document was intended to be applied only
to those things that were harmful.  

          The other confusion that becomes more clearly confused
with later documents is the exception given to clinical research. 
We're, I believe, still attempting to learn whether or not the
'62 Army regulation which codified the exception given to
clinical or therapeutic research was a codification of standard
practice.  That is, that is what was being done even prior to
that time or whether that was a new exemption.  So to the extent
that they may have looked at Saenger's work as being therapeutic
research, they may have determined that it had that clinical or
therapeutic exemption to the Wilson.

          CHAIR FADEN:  What if we look at the AEC policy? 

          DR. NEUMANN:  Well, that would be irrelevant because,
of course, the funding -- he used no isotopes, no radioisotopes.

          CHAIR FADEN:  Except that we yesterday -- and you
missed this part, Ron -- adopted as a committee the view that the
AEC policy could be taken as the policy of the federal government
overall for purposes of determining --

          DR. NEUMANN:  I think that's fine now.  I think you're
asking me, would they have believed that then.

          CHAIR FADEN:  No.  I'm not asking that.  I'm asking, do
we have any indication that the AEC policy was followed?  Dan, do
you want to get in on this?

          MR. GUTTMAN:  I think the answer is clear.  There was
no review.  The basic question, the other one, is would there
have been a technical justification for not doing anything? 
Clearly, nobody is saying -- this is not to say that Dr. Saenger
didn't early ask for consent but I don't think anybody is saying
that when the thing came along in '58 or '59 there was any formal
review, consent -- formal process of -- they're talking about the
whole experiment being reviewed for both parts.  There was none
of that as far as we can tell and there was no consent process
that was one that was following any government policy.      
     DR. NEUMANN:  Right.  Our knowledge of the review was solely
the project looking at that point for an amino acid to appear in
the urine.

          CHAIR FADEN:  We have no evidence that the reviewers
for the Department of the Army or DASA looked at questions of
consent that was claimed to have been obtained or would be
obtained from the subject as would be required, say, by the --

          DR. NEUMANN:  No, and there's nothing in their written
comments.  These are very brief, of course.  There's at most two
sentences from each reviewer and there's certainly nothing stated
there about any review of the ethical or informed consent.

          MR. GUTTMAN:  I think Ron's point, that the better
argument -- argument may not be the right word.  The more
interesting point is they were not really doing anything by way
of intervention or in any way doing nothing.  They were just
picking up data that was going to be collected otherwise.

          CHAIR FADEN:  Of treatments that were going to be done.

          MR. GUTTMAN:  Right, of treatments.  If there was an
explanation, that would have been the explanation.  Ron, is that
right?

          DR. NEUMANN:  Well, in their minds, I mean I can see
them interpreting it as an experiment of opportunity.  That is,
those people are being irradiated.  Let's take opportunity of
that and collect some blood specimens and urine specimens which
are innately very low risk procedures and not worrisome
certainly.  If they looked at the experiment that way and did not
think about the consequences or concern about whether or not the
radiation needed to be given therapeutically.  I'm sure, as
you've discussed, they accepted the status of the physician at
this point who applied and they more or less say he knows what
he's doing.  We don't think he's going to find anything with this
biologic dosimeter but he's a good person and he'll work on
something of more interest to us later.

          CHAIR FADEN:  So if we use the language of this
morning, it's the illustration of misplaced status trust.

          DR. NEUMANN:  It's the status.  

          CHAIR FADEN:  We're not going to be worry about it. 
We'll assume that if the doctors at the University of Cincinnati
say these people need to be radiated, they need to be radiated.

          DR. NEUMANN:  Moreover, they had probably knowledge of
Dr. Saenger's curriculum vitae at that point and he had been
through some of their better hospitals and had already written
documents on radiation effects and so on and so forth for various
government agencies.  So I would guess now that they probably
recognized his name as a quasi-expert on irradiation.

          CHAIR FADEN:  Phil, go ahead and then Mary Ann.

          DR. RUSSELL:  What reasons were given for transferring
the funding responsibility from Army R&D to Department of
Defense?

          MR. STERN:  I regret not having the actual document but
the senior reviewing officers had ultimately accepted the
proposal and then I believe in one sentence said, and therefore
contact or send it to DASA to effectuate the contract.  It seemed
from my recollection of the document on its face that it was just
standard procedure.  Okay.  We've accepted this.  We want this. 
Let's get DASA to effectuate the contract, write it, get it
signed and then I imagine oversee it.  That's how it reads and
that's all we know.

          DR. RUSSELL:  That seems to be a somewhat unusual
procedure and what it may speak to is DASA had a project that was
looking at biologic dosimeter.

          MR. STERN:  That's actually a very good point because
there were already two existing studies at Baylor and Sloan
Kettering that were being funded by DASA.  In fact, we have a
document in 1959 saying with this, with Cincinnati we now have
essentially a portfolio of contractors doing this type of
research.  We have a full plate here.  So I think maybe that's a
very good point.  That could be exactly why they turned it over
because DASA was doing it.  At the same time those other two were
also for the Army.  They were clearly DASA run contracts for the
Army and were commissioned by the Army and approached by the
Army, not the Air Force or the Navy.  

          DR. RUSSELL:  It sounds like DASA had the project, was
doing the funding, and they asked the Army to do a technical
review of the proposal.

          MR. STERN:  Saenger submitted -- it was an unsolicited
submission to the Army so maybe that affects how it works also.

          MR. GUTTMAN:  One of the things that may be missing
here -- this is all the non-evidence -- is that DASA had a
medical division and so we thought at the onset that
theoretically, what Phil is saying, there was somebody sitting in
the medical division who had got all these contracts and was
reviewing them, etcetera.  We've got, as in other cases,
fragments of documents from the medical division but if there
ever was a file for the whole body irradiation program, we don't
have it.

          CHAIR FADEN:  Mary Ann.

          DR. STEVENSON:  I guess another concern I have and Ron
or maybe even Jonathan can answer this.  It seems to me that the
regulation of cobalt 60 in 

-- therapy sources are for external beam radiation had sort of
slipped through the cracks in terms of regulation and the AEC
more or less signed off it in the document we looked at
yesterday, Catalog and Price List.  I think it's one of the tabs
here where they said basically that it's not considered research
by the AEC, use of cobalt 60 in this form unless there was a
significant program undertaken with the unit on the biological
effects of radiation.  So it was very wide open and to a large
degree I have a feeling that cobalt 60 -- therapy units just
weren't particularly regulated.  It was assumed they were being
used for therapeutic purposes and that was the end of the story,
unlike the use of isotopes where consent and regulation is
relatively strict.

          DR. RUSSELL:  So it's quite conceivable that nobody in
the system --

          DR. STEVENSON:  No one was looking after it.

          DR. RUSSELL:  -- looked at the radiation part of this
as being an experimental process.

          DR. STEVENSON:  Exactly.  That's my impression that
it's not.

          DR. RUSSELL:  The only thing experimental is collecting
the urines and blood and look for the dosimeter.

          MR. GUTTMAN:  Lest anything be simple, Gail has just
found in the -- Sciences files.  They had a committee called the
Committee on Growth that sort of took a gap in the cancer
research and were putting it together but it may be in the mid
'50s there was what you might call the primitive peer review
process for cancer research and that's where that organism in the
bureaucracy was.  We don't know.

          CHAIR FADEN:  But that would have been for NCI funded
work presumably. 

          MR. GUTTMAN:  But it would have been a standard -- on
the small community notion, it might have been something of those
are the standard, we don't know yet, and fill in the isotope gap
the way the AEC filled -- fill in the gap that the AEC filled
with the isotopes.

          MR. STERN:  Just to make a further point and follow to
Mary Ann, there was, at least at the early stages of the cobalt
60, some measure of regulation because cobalt 60 machine actually
was, I believe, developed and created jointly by the Oak Ridge
Institute for Nuclear Studies and when they established the Tele-
therapy Evaluation Board to test the machine by distributing it
to universities in exchange for a portion of the work done with
the machine being done on behalf of the agency.  So there was
some type of oversight or control of the use of that machine, at
least in the early years in the early 1950s.  The first machine
actually went to M.D. Anderson which then became the first
institution that was contracted by the Air Force to do TBI with
that machine.

          DR. STEVENSON:  But do we have any evidence that there
were guidelines in terms of use of the machine and consent?  I
don't think so.

          MR. STERN:  No.  No.  We don't have that formal stuff.

          DR. STEVENSON:  It's not parallel to the isotope
involved.

          MR. STERN:  That's right.

          CHAIR FADEN:  I know I've read this but I don't
remember.  At what point was the IRB at the University of
Cincinnati asked to approve any dimension of this?

          DR. NEUMANN:  Dr. Saenger and a colleague come back
with almost a different protocol but their intent in the mid '60s
is to support the patients after the irradiation with bone marrow
transplantation and they submitted that protocol to an IRB which
had then been formed.  I don't know how long before that period
of time but I believe that was '64.

          MR. STERN:  The IRB was formed in '64.  They submitted
their first protocol in '66 which was protocol to study
autologous bone marrow transplants, not the whole TBI.  That was
actually rejected or sort of sent back and it was revised.  It's
now a protocol to study the effects of TBI which are supported by
bone marrow transplants.  It is that protocol in 1967 that was
the subject of the --

          CHAIR FADEN:  -- the dispute about the one in four.

          MR. STERN:  -- the dispute about the one in four chance
of death.  In fact, one of the reviewers said, well, it looks
like this second protocol is really trying to do what the first
one was but it's being masked in different language.

          CHAIR FADEN:  I'm trying to uncover where anybody might
have had the chance, any group outside of the core investigators,
might have had a chance to comment on the prospect of benefit
risk ratio.  So we're establishing that the Department of Army's
Review Committee, it doesn't look like they commented on the
treatment at all but looked only on whether it was going to help
them with their biological dosimeters stuff and maybe the
psychological performance stuff.  We don't have any evidence that
at DASA anybody looked at the harm to benefit ratio of
irradiation for the patient subjects.        What I'm hearing is
that at least starting in '64 IRB approval could have been sought
but was not sought if you thought of it as research but if you
didn't think of it as research but just thought of it as
innovative or desperate, whatever, cancer therapy, then you
wouldn't have gone, that at least as of prior to '64 there was
nobody to go to, at least as best as we can figure out at the
institution.  As of '64, there's an IB and that IRB isn't
approached until '66 and then with what is initially an offshoot.

          DR. NEUMANN:  There's one further complication that you
might recall from our earliest description. In the beginning Dr.
Saenger borrowed a bed on a clinic ward.  Later the NIH funds a
clinical research center at that hospital and he begins to use a
bed there and they visited Cincinnati apparently and reviewed
that clinical research unit grant and I think that may have
actually been earlier than '66 but I don't have those documents
with me today.  Now the NIH has never been able to find anything
to substantiate.  I've seen a written document that said there
was a site visit by someone from the NIH but I don't recall those
dates so I'm just adding that to the mix here, but I don't have
the precise date at which that would have occurred so I don't
know for certain that that would have predated '66 but the NIH
was there and he was using a bed in a federally funded research
fund.

          CHAIR FADEN:  An HEW funded research ward at that
point.

          DR. NEUMANN:  Yes.  Well, it came from the NIH.  The
group that's now called the General Medical Sciences Institute
was funding clinical research wards to collectively bring
investigators into a space where intensive clinical research
could be carried out and they paid in essence, I think, the
hospital charges.  He also had fellow training grants from NIH.  

          CHAIR FADEN:  Phil.

          DR. RUSSELL:  You can sometimes tell the intent of the
contract and so forth by what they're actually paying for.  I
wonder if the data exists on whether in the early '60s the
Department of Defense was paying for hospital bills for these
patients.  Was it actually paying for the irradiation charges or
was it merely paying Dr. Saenger's laboratory support and
specimen collection because that goes to the intent of the
contract from the Department of Defense.

          DR. NEUMANN:  Yes.  That was actually investigated
during one of the number of investigations that Dr. Saenger's
project has undergone and they had the Department of Defense ask
OMB, I think actually, to look at it and their report was that no
federal government -- that is, DOD money was used to pay for the
treatment of the patients or the hospital expenses and that it
was intended to support the laboratory testing, as you suggest. 
Dr. Saenger in his personal statements has also always insisted
that he did not co-mingle funds and that he used general hospital
funds and other forms of non-federal government money to pay for
the care of the indigent patients.  Recall, this was a city
hospital at the time charged with the responsibility of caring
for indigent patients.  

          On the other hand, in response to Gary's question about
could you have done the therapy without the money, he gives the
curious answer, something like probably not.  That's in the
transcript.  I don't know that I've quoted him exactly but he
gives a curious response to that question that isn't entirely
coincident --

          DR. RUSSELL:  -- consistent with the information.

          DR. STEVENSON:  I think his quote was in fact he could
have but he probably wouldn't have.

          DR. RUSSELL:  He wouldn't have, and that may be more to
the point.

          DR. STEVENSON:  Right.  He is saying could have.

          MR. STERN:  Two quick points.  I do not believe DOD was
paying for like the patient bills.  They calculated the total
funding to be approximately for the 12 years about $1.5 million
of which the DOD money was approximately half of the total
expenditures, part of which paid for the laboratory equipment and
analysis, part of which paid salaries of a significant portion of
the staff that was working on it including, I believe, some of
the clinical physicians.  

          And just to clarify what Ron just said about the GAO
review.  The GAO was asked to review actually by Congress the
study and the funding of the study and what they report was that
they essentially just simply report what the DNA told them and
they state that the DNA said that funds of the DNA had been used
only to pay for supplementary laboratory analysis of patients who
had received whole body irradiation in order for the DNA to gain
information in areas that were relative to national defense.  So
GAO didn't do its own review.  It just accepted what the DNA told
them.

          CHAIR FADEN:  Henry.

          DR. ROYAL:  My recollection is that we actually had the
budget from the original grant application so what was involved
in terms of the budgetary aspects I think are pretty clearly
defined.

          DR. RUSSELL:  So one could make the argument that the
Defense Department didn't cause those people to be irradiated
except by indirectly encouraging Dr. Saenger in these activities.
I'm not sure I accept that but that's an argument that can be
made.  

          CHAIR FADEN:  Mary Ann and Lois.

          DR. STEVENSON:  I have another question.  Do we have
any documentation about the NIH grant reviews that were denied
three times?

          DR. NEUMANN:  At NIH, unfortunately apparently not.  I
mean according to them, it's their process to destroy non-funded
grant documents because they apparently just simply can't store
all that stuff.  So they haven't turned up anything.  Within the
University of Cincinnati review there are comments that Gary can
make.

          MR. STERN:  We do have one document which was from the
dean of the medical school reporting on a visit from the NIH to
discuss the fact that actually three protocols sent to NIH had
been rejected on ethical grounds, one of which was the TBI
project.  That memo is dated 1969.  It is presumably and almost
certainly the protocol that was sent in in probably 1968 that had
been provisionally approved by the Cincinnati IRB because the
memo says that NIH rejected this proposal on ethical grounds even
though it had passed through the Cincinnati IRB, and so he's
reporting back.  He makes the further comment that he did not
believe that the investigators had been informed of the reasons
for the rejection by NIH and had discussed with the NIH setting
up a program so that investigators would be informed in the
future for the reasons for such a rejection.  That's the only
documents we have.

          Another proposal was put to the NIH in 1971 or '72 just
at the time when this whole thing became publicly exposed and the
subject of media attention and the outside reviews.  The only
that's informed is that NIH refused to fund it but we don't have
a reason for that.  We still are inquiring with NIH to search its
records but we haven't gotten anything yet.

          DR. STEVENSON:  So we have no details in terms of what
the ethical objections were, just that there were some.

          MR. STERN:  Right.

          CHAIR FADEN:  Lois.

          MS. NORRIS:  Really two points.  Did you say that
enrollment of patients was discontinued between the time of the
IRB consideration of the bone marrow transplant version of the
protocol and the submission and I guess ultimate acceptance of
the revised form of that which you said was something like TBI
supported by bone marrow transplant.  Do you know if patients
were enrolled during the IRB?

          MR. STERN:  I believe patients were.  I don't think at
any time there was any pause or stopping of treatment of patients
from 1960 until '71.  The treatment sort of continued even as the
review process was in store.  Let me add.  Dr. Saenger in the
interview stated that he believes that they were never obligated
to seek that review  and that they did it essentially because
this thing was set up, they wanted to just follow the rules on
their own but, in fact, he I believe said that they had a
technical argument that they didn't have to and weren't subject
to the IRB because that was for federally funded research by the
NIH and this was already ongoing and so there is no obligation
there, but they decided to.  But I'm very certain that at no time
was there any pause in the treatment.

          MS. NORRIS:  Then I had one more point.  This is
related to the subject simply because it appears in this
particular memo concerning TBI.  I find it very interesting that
the ACBM of the AEC censured work done under the Manhattan
Project and it was a rather sharp exchange between Drs. Gregg and
Stone. I don't think I've seen this happening before.  Isn't it
rather unique that the ACBM took this kind of a strong position?  

          The other thing I happened to note, and this is just in
passing, it didn't seem to have hurt Dr. Stone's reputation in
any way because the next thing we see he's on the NEPA Advisory
Committee.  But that wasn't in the form of a question.  Isn't
this an unusual event.

          DR. NEUMANN:  To have it documented probably is.  One
gets the impression that Dr. Stone represented a certain very
conservative position that perhaps was the extreme of his peers
and throughout his career.  It's too bad that Gregg Herken is not
here today.  He's studied a lot of Dr. Stone in his review of the
Lawrence family.  But it appears that Dr. Stone represented a
position that was not necessarily agreed to by the bulk of his
peers with respect to the physician's ability to control what he
or she did vis … vis peer review.

          MR. STERN:  I guess I  would also just add very quickly
that that exchange between Gregg and Stone was in response to an
additional application for AEC funds to continue to study, to
monitor the patients that had been treated with TBI during the
Manhattan Project.  It was just to continue to monitor them, not
to do new treatments.  Stone in that letter says in bold face cap
letters that no additional treatments have begun.  It could well
be -- I'm not certain of this -- that in fact he may not have
received any -- apparently he was rejected for funding by the AEC
and he may have lost favor with the AEC.  You next see him over
at the DOD on the NEPA and then on the Committee on Medical
Sciences.

          MS. NORRIS:  From whence he came.

          MR. STERN:  That's right.  Well, originally DOD and
then became AEC so there may have been a difference of view
within the two different agencies on him.

          CHAIR FADEN:  Eli.

          DR. GLATSTEIN:  Just to put in historical perspective,
you say that they submitted to the NIH and it was rejected in
Cincinnati in 1969.  It would have been in the late '60s that
multi-agent chemotherapy would have been in a state of euphoria
over success in various diseases and virtually everything
disseminated became chemotherapy.  The ethical grounds for
refusal may well reflect that kind of euphoria.

          CHAIR FADEN:  I'm having a lot of difficulty -- I don't
know if anybody else is -- trying to figure out how to pull this
together from the perspective of the concerns that at least I
have about the experience and I don't know, since the two of you
have studied this more than any of the rest of us, how to really
-- it seems to me it sort of defies the neat little categories
that we have been working with.  I don't mean to minimize them,
but it's not simply an issue about consent nor is it simply an
issue about subject selection nor is it simply an issue about
risks and benefits or even simply a question about peer review. 
It seems to be in some ways a much more complicated kind of
picture.  

          On the one hand, what I am coming away with from doing
all the reading and now hearing your presentation is perhaps
there was something very wrong about the Department of Defense's
continuing pursuit of answers to questions that were important
through studies that were not likely to yield the answers that
were needed and because of some political problems, we're not
going to do it on healthy subjects.  We somehow still need to get
this dosimeter thing knocked down.  Let's take advantage of this
opportunity as it was perceived and yet we have people even then
realizing this is not likely to give you the answer that you
wanted for good obvious scientific reasons and this wouldn't be
so bad except as a consequence it appears that people were put in
harm's way.  And then the tough part gets to be this huge
counterfactual, but for the Department of Defense's and DASA's
interest in TBI being able to do opportunistic research on ill
patients who were given TBI, would this much TBI work in fact
have been done?  Is there any way to unpack that?

          DR. NEUMANN:  I think fundamentally the large question
in my mind is now when Stone says, we need to do the experiments
on normals in order to get the information that we require for
NEPA.  That's also true, of course, for the biologic dosimeter
and everything else.  That request from the NEPA is rejected
presumably by Shields Warren or at that level.  Warren says, we
have enough information from the Japanese bomb victims, the
accidental exposures, and we can do animal experiments.  

          It strikes me as funny that that was accepted and that
no one appealed that decision and said, no, for these reasons we
don't have the proper information from that series of cases of
exposure and let us pay volunteers.  I mean Stone lays out in his
letter exactly what was required post-Nuremberg for informed
consent and everything else.  Whether or not his request to use
prisoners is justifiable is a subset but at least he said, let's
do it openly.  Let's call for volunteers.  Let's inform them of
the risks and probably let's pay them although that's not in the
letter.  

          Instead of appealing that, for some strange reason the
Air Force then goes off and contracts with M.D. Anderson and we
have not yet found the missing link there as to why they elected
to do that because you're absolutely right.  I mean I've had this
discussion about why anyone would see sick hospitalized patients
as a group to be preyed upon, as it were, for this information
when they said you can't do this to normals and you can't do this
to prisoners.  It's inconceivable that someone said, but it's
okay.  Go into the hospitals through the back door and collect it
there.  I mean we don't have that and we don't have the
intellectual link that would explain why the Air Force elected to
do this at M.D. Anderson for the NEPA Project.

          CHAIR FADEN:  Jay and then Eli.  I'm sorry.  I think
Gary wanted to respond.

          MR. STERN:  I can wrap up afterwards.

          CHAIR FADEN:  Okay.  Jay and then Eli.

          DR. KATZ:  I'm going to help you to unpack it but it's
something that we've been talking about off and on for months. 
To begin with in terms of unpacking it, what is our world view of
the '40s, '50s and '60s?  If we start out with a world view of
the 

-- it's a little of an overstatement but for emphasis 

-- of the ethical chaos in a certain sense of the '40s, '50s and
'60s.  It's not quite true but in terms of how people operated --
and ethical chaos.  Then we can proceed from that world view and
try to describe it and then make comments about it.  If we start
out

-- I'm not talking now about the Wilson Memorandum.  I'll come to
that in a moment.  But if we start out from, as our anchoring
phrase, the Nuremberg code, we come to some other conclusions but
we then have to also say, what was the meaning of the Nuremberg
code in the world of the '50s, '60s and '70s?  

          We seem to have the coming of the Wilson Memorandum, we
seem now to have latched on to the Wilson Memorandum as a
security blanket almost.  I mean this is becoming a mantra in
part.  This is what is going to be the thread that will get us in
and out of the -- or something or other.  I don't think it's
going to help us and there's differences but we're picking on
this one at the meeting and somebody maybe can empower somebody
to say that, okay, this is our starting point and go on from
there and see what will come out.  But I think that is the need.  

          CHAIR FADEN:  Eli and Phil.

          DR. GLATSTEIN:  To sort of bridge what he has said and
to get back to the question that you raised, in my mind it's
probably oversimplified but I think it comes down to vested
interest as opposed to peer review in terms of the information
that you want to believe.  I believe that the situation was that
vested interest won out because the end will justify the means if
vested interest is in fact what really made the decisions. 
Military, in dealing with an outside peer review group, got a
response they didn't really like.  Maybe the decision would be a
hell of a lot simpler just to sponsor this kind of piggyback
study and get the information that they wanted anyway.  It's
simpler and in the end would justify the means regardless of the
ethical considerations.  If you're not an advocate for peer
review, it's easy to find fault with it but it's like democracy. 
Nobody has come up with a better system.  I think that what
you're talking about in the military -- to get back to Ron's
response about why the military just let go of this issue and
started to deal directly with institutions to generate the data
they wanted.  I think it was just a hell of a lot simpler.  They
were having trouble getting what they wanted through the outside
advisory group.

          CHAIR FADEN:  So they go this route.

          DR. GLATSTEIN:  You can bypass it.

          CHAIR FADEN:  So then turning around from the other
end, how do we construct it if the military hadn't expressed this
interest and found collaborators.  Would we have seen TBI for
solid tumor?  This is so counterfactual.  

          DR. GLATSTEIN:  I think you probably would have but I
don't think it would have gone on nearly as long.

          CHAIR FADEN:  It would have stopped sooner.

          DR. GLATSTEIN:  Yes.  I think it would have been an
event that somebody would have seen what was done in Texas and
say, well, maybe they didn't do it right.  They would have done
it again.  They would have done a couple of dozen cases, come up
with the same conclusion and probably let it go.  The astonishing
thing about the Cincinnati experiments were that they were
ongoing for essentially a decade.

          DR. RUSSELL:  You'd think they'd have quit after a
dozen.

          DR. GLATSTEIN:  Yes.  I mean that's the hard part to
understand about Cincinnati was it was an ongoing theme
throughout the '60s and into the early '70s and realistically I
think it would have come up again but I think somebody would have
dropped it very quickly.

          DR. NEUMANN:  But again, please be clear.  When we
asked him that, he said, well, had we found the biologic
dosimeter, we would have stopped.  But he didn't.  He didn't find
an amino acid.  So then his next series of experiments looks for
breakdown product from nucleic acids.

          DR. GLATSTEIN:  Her question was if he hadn't been
sponsored, would someone else have done the work?  The military
would have sponsored the work anyway.  They were already doing
it.  That's what you told us.

          DR. NEUMANN:  The other way you can look at it is to
our knowledge no other agency was funding TBI for solid tumors in
the 1960s to '70s.

          DR. GLATSTEIN:  When they funded Saenger, they already
had two other institutions that were ongoing and they wanted to
keep this guy going because they could work with him.  He had a
track record.  Just a hell of a lot simpler to deal with that.

          CHAIR FADEN:  Phil, do you want to weigh in?

          DR. RUSSELL:  I tend to agree with Eli in the sense
that the military view was that we can't irradiate volunteers. 
Therefore, we're going to examine people that are being
irradiated by the medical --

          DR. GLATSTEIN:  And again, as long as someone is
willing to do it, the end will justify the means.

          DR. RUSSELL:  I'm not sure.  There's no evidence that
that thought process occurred.  

          DR. GLATSTEIN:  No.  In fact --

          DR. RUSSELL:  Let me finish please.  What they didn't
predict was the continued stimulation of that ongoing.  So what
we have here is some bad administrative judgment on the part of
the DOD to begin with with the program.  We have very poor
medical judgment going on at the treatment level compounded by
oversight failure on the administration at the medical center. 
We have very bad science that is documented by negative
scientific reviews and then we also have some poor administrative
judgment at the contracting level.  

          So it's quite clear that you can point to failures of
proper judgment in about eight points in this matrix.  Which is
the dominant one and where the blame lies in terms of real
culpability is very difficult because you can see a lot of very,
very bad judgment at all levels and in all aspects.

          DR. GLATSTEIN:  But to get back to the question that
you raised, Ruth.  If they hadn't sponsored Saenger, they already
had some material from Baylor and Anderson.  There were two other
ongoing institutions at the time they sponsored Saenger, and
there was work going on at Oak Ridge of a very similar nature and
which was criticized in a House hearing in I guess the early '80s
that for almost identical reasons that Ron has identified as
being problematic with these studies.  No good end points.  The
sorts of things that were being done, there was no goal in terms
of the scientific endpoint.  It was poor quality work.

          DR. NEUMANN:  Yes.  I mean it strikes me as
particularly peculiar.  To answer Phil's question, we do in fact
have a well, okay, this is the second best to do it in patients
type of document and they sort of gave up.  But it's astonishing
to me that, A) they didn't appeal the decision, B) that they
didn't use normal primates which, in my mind, would have been
next best and clearly doable at the time for at least the
biologic dosimeter, not psychological testing, of course, but the
biologic dosimeter work.  Instead, they accepted second best and
the end result is data that didn't really enhance their
understanding of this entire problem and perhaps is not
applicable to normal individuals.  Their goal was to find out
normal individuals' tolerance to radiation so they really at the
end of all this did not answer that beginning question that they
had.

          CHAIR FADEN:  I want to just get a sense now of how
many people have comments to make or questions to raise so we can
figure out when to have our break.  After the break, we will turn
to the discussion of where the final report is going and time
tables and stuff like that, which is very important.  We need to
spend at least a half hour doing that.  I saw Henry and Pat and
Gary to respond.  Do you want to respond before their comments on
this one?

          MR. STERN:  I can wait.

          CHAIR FADEN:  Okay.  You've been very patient, Gary. 
You probably have three pages of notes now.

          I see Henry and Pat at minimum and then I'm not sure
whether we want to take a point and pause and say, okay, what do
we know now?  What kind of statements are we prepared to make
about either wrong doing or culpability?  We should at some point
stop and see if anybody wants to comment on the general
questions.  Henry and Pat.

          DR. ROYAL:  I'm a little bit confused about where the
line of thinking that the military was interested in the
biological effects of radiation and their interest in
biodosimeter and that that somehow was bad.  It seems like it's
legitimate that the military should be interested in radiation
effects.

          CHAIR FADEN:  I don't think anybody argued about that.

          DR. ROYAL:  Well, that their interest led to
perpetuation of TBI.  That's what I thought I was hearing.

          CHAIR FADEN:  No.  I think, at least what I'm trying to
get at, is not that it was wrong that the Army was interested in
getting an answer to that question which seems very important for
lots of reasons, the little bit that I understand in this world,
but that they sought the answer, as Ron points out, not through
either appealing and saying, look, we really have to use healthy
people to do this right because we have healthy people to whom we
want to generalize or, if we can't, let's -- we have no evidence
that they didn't do it in primates first which raises other
issues, but still certainly there would be an argument to explore
about whether we can't check this out in healthy primates.

          DR. ROYAL:  What I was going to say is that there were
a number of different options available to get that information. 
Primates were mentioned but the other thing is whole body
irradiation was being done for these radiosensitive tumors.  That
was not the preferred group of people to do it in because of the
--

          CHAIR FADEN:  Hemologic changes.

          DR. ROYAL:  Well, it was mainly because they were
trying to measure amino acids in the urine and if you had a very
sensitive tumor, the killing of that tumor was going to release a
lot of amino acids and overwhelm whatever signal you were looking
for.  The main point I'm trying to bring out is that there has
been a continued interest in the effects of radiation, a
continued interest in biodosimeters and, to my knowledge, the
military continues to support that activity.  So maybe I
misinterpreted what you said.  What I thought I was hearing said
was that the military should have just stopped being interested
and that would have taken care of this problem.  So I did not
hear that.

          CHAIR FADEN:  No.

          DR. ROYAL:  I was getting the impression that it was
inappropriate for the military to have been interested.

          CHAIR FADEN:  No.

          DR. ROYAL:  Okay.  Sorry.

          DR. GLATSTEIN:  It's how they collect the data.

          CHAIR FADEN:  Where they look for the answer.

          DR. GLATSTEIN:  Exactly.

          DR. RUSSELL:  Do you think it's possible to do those
experiments in an ethical manner given the fact that there was an
ongoing total body irradiation of solid tumors on a purely
medical basis that the Department of Defense was not supporting
and the contracts apparently indicate that they did not support
the irradiation of those patients.  So it would seem to me that
all they'd have to assure themselves was that the patients were
informed why the specimens were being collected and for what
purpose and that they agree and that the investigator didn't do
any more irradiation of patients than was medically indicated. 
It could  have been done very ethically and so what was not
ethical about it?  

          In my mind what was not ethical about it was they
didn't get the express permission from the knowledgeable patients
about why the specimens were being collected and they didn't
assure themselves that the irradiation was indeed being done
totally for medical purposes unrelated to the dosimeter
experiment.

          DR. GLATSTEIN:  There are questions about how it was
done in Cincinnati.  There are no questions about how it was done
in Texas, the earlier studies.  Those studies are clearly
ethical.  The ethical questions about Cincinnati had to do with
the dirty details of exactly how it was carried out and Dr.
Saenger's willingness to distance himself from the selection
process seems actually very appropriate under those
circumstances.  However, the real question has to do with what
the patients understood.  What was conveyed to them?  What was
the risk as they understood?  Were they deceived in having that
treatment in order to generate the data?  I don't think we can
answer that from our position here.  We can only say that that, I
think, is really what the question is about.

          CHAIR FADEN:  Pat's got the floor next.  These are
tough questions.

          MS. KING:  I can't put this in culpability terms in a
way we've discussed it, but I have several thoughts.  One, it is
possible, in my mind, for a study to be unethical because it was
not scientifically sound.  I certainly am not a scientist but I
keep hearing a lot of statements around the table that question
the scientific justification for doing this study even if consent
had been obtained at certain stages of the study.  I can't speak
for its initiation but I heard several points, real doubts about
why it continued and went on.  So that's my first point.

          My second point is that I think of this in terms of
what this study might tell us and I am reminded that when we look
for evil -- and that's too strong a word, but I use it now
deliberately to get attention -- people want to look for
intentionality, they want to look for what we've been calling
culpability.  I think you can get evil as a result of
administrative bungling in terms of the results, and I use evil
only to overstate what I'm saying.  And that is a cumulative
process of administrative mishaps from the victim's perspective
is every bit as bad as somebody intentionally setting out to do
it in a certain way.  There is an argument that Tuskegee was an
administrative nightmare.  Those continual administrative foul
ups, etcetera.  I'm not questioning that.  I'm just saying from
my perspective that is a serious issue.  You don't have to call
this story culpability.  It is, as Phil described, things that we
can identify as going awry at several different points, the
culmination of which is to create a situation.  

          My first question is, well, my God, we could have that
again.  What I am interested in is first of all, getting people
to understand that not everything that creates or has the
possibility of creating serious harm has to come from these
deliberate thinking or negligence.  It can come from something
much more benign.  Was it Hannah Arendt who talked about the
banality of evil?  That's the point I'm trying to make, and I
think that there's a value in describing something that has
happened in those terms with the objective of trying to identify,
which is the other part of our mandate, with the objective of
trying to identify, not that we can completely prevent this from
happening again but what lessons we can learn and what we would
recommend.  

          For example, this is just in the memo that we have
here, when Dr. Gregg is talking about the obligations that flow
from conducting work in secret,  AEC conducting work in secret, I
actually think for me it's a very valuable observation.  It would
be one that I would agree with.  What clearly was not present
here were anybody that was responsible for taking a second look
at all this research as the funding went on to say, gee, nothing
is being accomplished, nothing has been established, etcetera. 
We even cut it, review it, etcetera.,  I don't find this shocking
if we remember cost overruns in the Defense Department and a lot
of other stuff.  But cost overruns is one thing.  Putting humans
in jeopardy I think is another and I think that that is something
worth telling.  

          I can't label it for you, Ruth.  I mean in terms of how
it fit into our culpability structures before and the way we
tease this out.  But I think this work has value, what we have
here, has great value in terms of what it might instruct us about
and maybe we should think about it in those terms, especially if
we can document fairly crisply, which I'm not sure we can do yet,
the bungling that we're really worried about and this may be an
example of wanting to make that statement as well.

          CHAIR FADEN:  Jay .

          DR. KATZ:  I'll be very quick.  I'm just delighted with
what Pat said but it goes really to what I said in a general way,
what's our starting point?  Even though I like to use that word
evil in terms of --

          MS. KING:  I only overstated it to make my point.

          DR. KATZ:  It's an overstatement and not an
overstatement, but in a certain sense we're going back to some
discussions we had two or three months ago before we definitively
said on the culpability dimension, though we do have reduced
culpability but I just want to say that I'm very much with Pat,
maybe not on the details but in general what she's talking about.

          MS. KING:  I don't want to lose TBI because we're
troubled by culpability and I would agree with Jay that I don't
want to lose culpability either.  It may be fine in some cases. 
That's not what I'm saying.  But I don't want us because we were
looking for something in these cases and can't find it to ignore
what these cases can do for us as well.  That was basically what
I said.

          CHAIR FADEN:  Nancy, did you want to say something now
and then Gary has been waiting.

          DR. OLEINICK:  Just a corollary to what you were
saying, Pat.  I don't disagree with anything you said but I have
some comment about it.  The first thing you said was that a study
can be unethical because it's not scientifically sound and I
completely agree with you and I think this may be a case for
that.  Maybe we didn't -- I mean the scientific community didn't
know that it was not sound when it began but at a certain point
it became evident and it should have become evident to a
competent investigator that there are only so many times you do
the experiment and if you don't get that result, you start
developing a new hypothesis.  So the fact that it continued too
long is really scientifically --

          DR. GLATSTEIN:  There are other things to try.

          DR. OLEINICK:  Try something else.  The question about
the administrative bungling, I mean clearly there was
administrative bungling but I think it's also more than
administrative bungling because we have cases where there have
been cases of oversight of the TBI where people actually looked
at it.  We have this quote, "well, we're going to let Saenger do
this experiment but we don't really think much is going to come
out of it but maybe some day he'll change his mind and do
something else."  That's kind of not exactly what I would call
administrative bungling.  I mean that's an oversight committee
not doing its job.

          DR. GLATSTEIN:  That was an advisory committee?

          DR. OLEINICK:  It's an advisory committee of some sort. 


          CHAIR FADEN:  The review committee from the Army --

          MS. KING:  I would agree with Nancy that there are many
errors.  What we're going to have trouble is when you create
narrow boxes, you get into the problem of how you jam stuff in
boxes.  I don't want to do that with this issue because what you
just described by some would be said as more than administrative
bungling.  By others it would be called exercise in poor judgment
and people would want to argue context of how difficult it is to
critique colleagues, the downside of peer review that we never
talk about.  I would be satisfied actually to surface all of
these ways of looking at it.  I don't think that we need have to
pick one over the other is part of what I'm saying.  I think the
news here is bad and the point is we don't want to lose data and
we can talk, at least to me, in more subtle terms about
obligations of professionals which actually if we get to it, we
may get to some real culpability, or in terms of talking about
how in the future, which I also don't want to lose sight of, if
there are ways to facilitate or empower people to speak up and
say, this is nonsense.  Why do we keep funding this guy when this
is what has come out.  That is what we're after it seems to me.

          DR. KATZ:  But Pat, oversight committees in those days
would have maybe done some good but they wouldn't have helped us
very much because they didn't really know what to oversee.

          CHAIR FADEN:  I don't think that's true.  I find that
inappropriate.  When you're concerned with the issue of harm and
benefit, consent is one thing, but when you're struggling with
the issue, after a certain point there is no -- if in fact --
let's take one characterization, Jay, and that's the
characterization which may not be accurate but that has been
presented that at some point it seemed evident to most competent
investigators that this was no longer beneficial.  There was not
evidence that this was beneficial to patients and it carried a
substantial risk.  If it had been cast in a context where there
had been review focusing on harm and benefit, I would put consent
aside or I would agree with you.

          DR. KATZ:  Forget about consent but we're talking about
oncology researchers of the past is confronted with desperate
situations, both in semi-research and research of using
impossible kind of treatments for research and therapeutic
purposes.  It's clear that they were in those days very much
confused what the permissible limits were.

          CHAIR FADEN:  I don't doubt that but I'm taking it to
its extreme.  At some point, sure there was confusion.  There
continues to be confusion.  We continue to have huge fights about
when to stop a clinical trial.  I mean it hasn't really gone
away.  But there is a point at which you start to reach, at some
point in some studies you read a consensus that this is over the
line.

          DR. GLATSTEIN:  It shouldn't take 90 patients.

          CHAIR FADEN:  That's all I'm suggesting.  I didn't mean
to respond so intensely but I want to step back and suggest that
we were -- I wouldn't want to leave the impression that there
were absolutely no barometers or context against which judgments
could be made or that we're somehow a whole lot better at doing
that now than we were then.  

          Phil and Mary Ann.

          DR. RUSSELL:  I think Pat's analysis is very, very good
and whether you call it bad judgment or administrative bungling
or whatever you call it, a set of circumstances had to pertain to
get an outcome that's this bad.  If you go back and look at it,
you think, that could have been stopped by a couple of scientific
reviewers saying, this is crap and we're not going to pay for
this.  It could have been stopped by the investigator himself
saying, I'm not getting any place and why don't I do something
else.  It could have been stopped by a hospital oversight group
of some sort saying, this isn't good science and it's not getting
any place.  It could have been stopped by a half a dozen
different things that didn't happen.  Many of them are in place
now and the checks that would have stopped this are in place in
many places now, but they didn't happen then and we've got a
very, very bad outcome from an additive set of poor judgment in
four or five different places in the chain of events.

          CHAIR FADEN:  May Ann. 

          DR. STEVENSON:  I think if we're going to try to answer
this question of government culpability and DOD in particular, we
have to decide whether we're taking a narrow view or a broad
view.  If we take a narrow view, you say, did the DOD ethically
fulfill a responsibility in terms of insuring ethical practices
in that narrow sphere, just collecting blood samples, urine
samples, informing the patients as to why this was being done and
the discomfort of a blood drop.  

          If you take the broad view, then you say, their
responsibility extended to evaluating the medical ethics of the
larger TBI program that they were piggybacked on to.  

          Now, from reading the documents, I would say that the
DOD is taking a narrow view and that's why they were somewhat
lackadaisical about, you know, it may not do any good.  It was
sort of a low budget, low expenditure, low energy item in their
book.  I'm not saying that's right.  I think that was their
attitude. 

          So that left the university and the investigator to
police or review the larger topic which was the medical ethics
and appropriateness of TBI and they quite clearly failed on that. 
I mean at least in my opinion of reading the review board, they
raised very serious objections and didn't seem to ever follow
through in a very dogmatic way in regard to the TBI work and
ultimately the NIH censured them by refusing their grants, but
that wasn't enough to stop the process.  Ultimately bad publicity
did.  But the processes of review that were in place failed or at
least the one did.

          DR. RUSSELL:  I think you're absolutely correct that
DOD was taking a very narrow view and thought they were okay and
that was a very bad judgment error.  They relied on the --

          DR. STEVENSON:  -- the university and the
investigators.

          DR. RUSSELL:  -- university authorities and they
failed, too.  They had multiple failures.  There has to be
multiple failures to have an outcome like that.

          DR. STEVENSON:  So somebody taking the attitude of
benign neglect almost of the DOD turned out a very, very bad
outcome.  That may be something we want to address, that it's not
okay to take that sort of attitude that their narrow sphere and
looking at their narrow sphere was sufficient in this particular
case.  

          CHAIR FADEN:  Gary has been waiting very patiently.  I
see Pat wants to respond as well.

          MS. KING:  I just want to add a quick statement and
that is in looking and going back over when we as a staff clearly
will do, the other item that I did not mention is that DOD's
piggybacking contributed to what I think is a major problem in
this area and that is administrative convenience and I don't want
to lose site of that because if the hypothesis that they went to
sick patients because they couldn't do normal patients, some of
the discussion we had bears proof, that's really an
administrative convenience question as far as I'm concerned and
this is an administrative convenience question with respect to
vulnerable subjects.  Vulnerable on several counts of
vulnerability.  I forgot this when I was talking before.

          CHAIR FADEN:  We haven't even touched on who these
patients were.  

          MS. KING:  They're multiply vulnerable.

          CHAIR FADEN:  Multiple levels at which they could be
understood to --

          MR. STERN:  I wanted to add that I think the discussion
that's just preceded has very effectively dealt with one of the
ways of trying to unpack this which was actions of the
administrators and the overseers and I think one thing we can
look at that you did discuss is the notion of a pattern, the fact
that, as we've been able to uncover so far, all in all the one
instance, the only institutions doing radioresistant treatment in
cancers with TBI was the DOD.  

          But another way to try to sort of unpack the problem
that Ruth raised is I think to return to Henry's question at the
beginning of this discussion of what would you do, what would a
reasonable person do in terms of accepting this therapy?  I think
it clearly is based on a full explanation of the facts but I
think you can't, where there is distinct evidence and certainly
in the Cincinnati case very early on that the doctors themselves
recognized that at the high doses it was causing severe problems. 
It was killing patients.  They knew it was happening through the
bone marrow and they then sought to try to fix that problem by
trying this autologous bone marrow transfusions which was what
those protocols were about.  The problem is it took them six
years to make that work or begin to work and yet throughout that
time they were continuing to treat the patients at the same
doses.  

          So I think there is a distinct body of facts there that
go directly to that question of should you be treating patients,
giving them these doses, in which you know that there's a
distinct risk of damage to the bone marrow and creating extremely
high risks on those patients without being able to protect them. 
I think the doctors were aware that that was a problem and it's
just not at all clear that the patients were ever made aware that
that was a problem.

          CHAIR FADEN:  I'm inclined to think we should take a
break and switch topics, not that we're resolved or ended this,
but is that amenable?  Let me ask this.  Some people, at least
two committee members need to leave by 4:15 for trains and
airplanes and things.  Could we if it's humanly possible take the
shortest conceivable break, like five minutes for major bodily
necessities.  No phone calls.  Not that kind of stuff.  We'll try
to end at 4:15 or close to it.  Reed needs to make an
announcement when he comes back.

          (Whereupon, off the record for a 12 minute recess at
3:46 p.m.)

          CHAIR FADEN:  Okay.  We're going to start.  Reed, do
you want to make an announcement.

          DR. TUCKSON:  The announcement I wanted to make is just
for the outreach committee.  We need to try to schedule a quick
telephone conversation like maybe Tuesday or Wednesday.  I'll
call your offices about four issues.  There are four issues that
we need to talk about.  Let me just remind the people that are
going on the next visits to Santa Fe on the 30th and Los Alamos
on the 31st, Duncan and Ruth, but we can talk about that visit. 
The Knoxville visit on March 2nd and that's I think Mary Ann and
Nancy.  

          The second issue is the notion of the staff who've gone
on the other site visits.  We need to hear from them as follow-
ups so we'll know what happens.  I got some disturbing
correspondence that described some intimidation that one of the
witnesses that we have has experienced since she's been back. 
Those kind of follow-ups I think the committee needs to hear
about.

          MR. GUTTMAN:  At her home site and I think we have
written or Steve or has written letter to the Justice Department
about that.

          MR. KLAIDMAN:  We have a letter from a woman named --

          DR. TUCKSON:  Let's not use names.  Let's just say that
we got a letter and that we are --

          MR. KLAIDMAN:  The letter has been transmitted to the
Justice Department through the inter-agency working group and
they will respond to it.

          DR. TUCKSON:  As I say though, it's just those kind of
things and also the notion that we need to specifically figure
out how we will incorporate this testimony that occurs late in
the game in the general work plan of what we're doing so that we
are aware of that.  So we want to just kind of have some
discussion about those kinds of points and then, as I say, the
follow-ups also.  So the staff that's been doing the follow-up we
need to have available. 

          Finally, there are some issues regarding public health
that we need to discuss and there's a person that needs to be
interviewed, a couple of people really that need to be
interviewed and we could talk about that as well.  I just want to
put you on notice.

          MR. GUTTMAN:  This isn't in relation to the discussion
you had at the last meeting with Ms. Colley or is it a different
matter?

          DR. TUCKSON:  A little different but it's the notion
again of how is it that such strong opinions are presented to us
in these visits that everybody on my block has got cancer and
everybody within a mile radius.  There's no involvement of the
public health system in this.  Nobody is collaborating this data. 
The question is, what's that all about and how can this be?  I've
been doing some work on that myself and there's a particular
health officer that was the health commissioner for both the
states of Oregon and for Washington who also has worked with the
DOE and so there are some interviews that we need to try to get
at.

          Lastly, there are some matters regarding the advocacy
community that have surfaced that the committee and staff need to
review.  So there's a bunch of stuff that needs to get done.  I'm
only presenting it so the rest of the committee has a sense of
some of the things that are happening with outreach and so that
staff is prepared.  If Steve will go ahead and work with us and
beat us to death and get this conference call arranged for our
schedules and staff availability, I think we can get this done.

          MR. GUTTMAN:  So you and Jay support a one year
extension of the committee.

          DR. TUCKSON:  Whatever Jay says I support anyway.

          CHAIR FADEN:  So we've got it and those of you who are
on the Outreach Committee are on notice that you've got to make
yourselves available for a call early next week.  Every committee
is getting calls early next week.  Every sub-committee, I should
say.

          In the short term left to us, let me remind you of a
couple of things.  Yesterday Jeremy and Nancy mentioned there was
going to be a new version of the instruments of the public
interview study and they needed to have the responses right away
if you cared.  It's at your seats already so it looks like this
and it has a date of January 19th on it.  I can't remember now
because I think  I repressed it.  Jeremy said they needed to have
it by what?  Tuesday morning?  Tuesday at noon.  It's one of
those speak now or forever hold your whatever.  So if you have
comments or reactions, things you want them to change, now is the
time.  Send it to the Advisory Committee offices and we'll make
sure that Jeremy and Nancy get them immediately.  The concern is
we've got to introduce those changes in time for them to be
available Friday.  We're going down to RTI to train the
interviewers, so I'll be down there with Jeremy and Nancy and
we'll be working on that part of the project and it's much, much
better obviously, it's clear, if the interviewers are trained on
what is basically the final instrument.  We don't want to be
making changes after they've already been trained as to how to
conduct the interviews.  So that's the schedule there. 

          Now we're going to turn as quickly as we can to kind of
what the game plan is for the rest of the life of the committee. 
Let me just remind everybody that we had raised the question of
the remaining meetings being two and a half days long rather than
two days long.  Nobody likes this but I really don't see any
choice if we're going to get this done and so the operative
assumption the staff is working on with people on their calendars
is that the dates that you have held will not be changed but
we're going to tack on half day on the front generally in most
cases or it's not clear yet?

          MS. MASTROIANNI:  It's clear.  The way the days work
out, we have no choice.

          CHAIR FADEN:  So there will be a tacked on half day and
we know this plays havoc with people's schedules.  We don't know
how else to do it.

          I also want to remind you that we asked everybody to
tentatively hold dates in May in case we have one extra committee
meeting.  At least continue to preserve those dates in May.

          DR. KATZ:  If we keep those dates we have which we
probably will have to, I can not come the half extra day because
I'm teaching that day.  

          CHAIR FADEN:  You teach on Wednesdays?

          DR. KATZ:  Yes.

          CHAIR FADEN:  I don't know.  We'll try to do something. 
We can also consider Saturday mornings.

          DR. KATZ:  If some people are willing to come Saturday
morning --

          CHAIR FADEN:  Maybe we can split them or something. 
We'll do a quick poll around and see maybe at least that we don't
lose Jay every single half day.  We'll just do the best we can. 
We should have anticipated this in the beginning.  We didn't
anticipate it in the beginning so now we're sort of stuck having
to live with this.  We know we're going to lose people because we
didn't tell you to save two and a half days so we're stuck but
better to have eight of us than none of us.  Whoever we can get,
we'll get.  We'll figure this out.  Unfortunately, Jay, we're
stuck on the February one because we already had to make a
commitment so that will be the 15th, 16th and 17th beginning at
2:00 on the 15th so that West Coast people can get here.  You
have to come in the day before anyway so maybe we should start --
let's think that one through.  What time is best?  Forget it. 
Doesn't help you any.  I'm sorry.  There's really not a whole lot
else we can do about it.

          Dan, can you quickly run us through this.  We have
something to pass out.

          MR. GUTTMAN:  One of the things I was working on, the
human experimentation with atomic bomb tests, isn't on here which
is okay.  It's less work for me.  In any event, what this is is
fairly self-explanatory.  This is a listing of the chapters which
is consistent with the outline in the draft book that you have. 
Needless to say, as we work along things maybe emerge, et cetera. 
The basic notion, as discussed at the last meeting, is to try to
give it a shot at forwarding as many chapters as we can.  What
this presents is that by the February meeting you'll have some
initial rough drafts of most of --

          CHAIR FADEN:  Many, not most.

          MR. GUTTMAN:  Well, it should be most.  Actually it's
most.  The reality may be many, not most, but this says most.  

          CHAIR FADEN:  A lot.

          MR. GUTTMAN:  What we're experiencing is what you would
expect we would experience.  There is a great difference between
describing something -- when I was working with Gary and Ron, you
know, between telling everything about every patient in these
experiments and writing in the way, we'd say, why would the
public want to know any of this stuff?  And that's sort of the
transformation leap.  So for those that have gone through and
iterations are ready, you can make that leap.  For others, each
chapter is a different problem.  There are gaps, etcetera.  The
general notion, to fit into the discussion earlier today with
Allen, is if we can that staff will write this in keeping with
the committees.  We'll have to talk about the way the
subcommittee is up, but that we'll write it in an even-handed
sense that will tell the story and obviously we're going to tell
the story in the way that we see it which doesn't maybe comport
with other people, but leave open the conclusions so that we'll
state the themes at the beginning and then tell the story
consistent with the themes but whether there's culpability or
whether there's not culpability or what the conclusion or the
lessons will be up for this committee to decide.  Looking at the
TBI as an example,  we had that as a draft chapter and at the end
there were questions and they went some direction answering the
questions so that now Gary and Ron can go back and redo that
chapter in keeping with that.  The notion is that we won't wait. 
We'll proceed with the chapter with some sense of where the
stories are but that the conclusion to the chapter, the staff
won't be writing the conclusions.  The committee will be writing
the conclusions in essence but that we'll be synch in trying to
develop what the themes and the questions so that you can then
struggle over what the concluding --

          CHAIR FADEN:  What to make out of it.

          MR. GUTTMAN:  Yes.  What to make out of it.  For many
of these chapters, we've gone from a set of subcommittees that
deal with other problems.  There's no linking up of committee
members and chapters.  

          CHAIR FADEN:  For some chapters there remains a tight
link between subcommittees and chapters.  In other cases, there
isn't but we're getting quickly to the point where everybody is
going to have to be responding to everything anyway so I'm not in
the mind today -- For the subcommittees for chapters that don't
have homes, what we're going to do is as drafts are available,
you'll get them as individual committee members and you'll be
asked 

-- you already have been asked in the case of three or four
chapters -- I can't remember now -- to please send your written
comments in.

          MR. GUTTMAN:  Eight and a half pounds.

          CHAIR FADEN:  Eight and a half pounds.  

          CHAIR FADEN:  Send your written comments back to staff
as quickly as you can.  There is a deadline.  The plan will be
there'll be a revision of that chapter in the light of as many
comments as have been received.  At some point in the process, we
will have a group discussion of the chapter.  Given the time
frame, we'll have to do this pretty quickly.  And if staff feels
that it's been vented enough by committee members that we can now
have a group discussion.  So I don't think we should worry about
it too much.  Some chapters have historically inherited relevant
subcommittees.  Other chapters it's okay.  We all own all the
chapters anyway.  We're all going to have to start taking
responsibility in the end for all of it and not only for the
chapters that we have invested more in.  So that's how it will
proceed.

          MR. GUTTMAN:  I guess the other things you probably are
interested in is that clearly there are gaps.  My basic view is
that there is no chapter that is not doable.  You can always
organize at some level of information and communicate something. 
All these chapters are doable in some sense.  They are doable on
a scale of C+ to A+ and that's what we're going to be talking
about here.  I want to put in a plea for Gregg.  I usually use
Gil but Gil's here.  I won't mention Gil.  Gregg, first when he
submitted his California draft, his concern was that Eli and
Henry and Mary Ann would say he flunked science in high school. 
Now Gregg is increasingly confident this is a terrific Pulitzer
prize winning chapter and he wants to know what the committee
thinks about it.  He keeps on asking, what's the feedback?  Don't
tell him if it's not nice.

          CHAIR FADEN:  For what it's worth, just so people can
be anticipating what's on the agenda for February, it's a massive
agenda.  We're again trying to make sure that as much as possible
time is spent in committee discussion.  My sense, I hope it's
shared, is that the time we spent together at this meeting
talking as a group has been well used.  We obviously in some
cases have used the time better, but dialogue is now really what
we need to be doing, talking together, arguing with one another
and seeing if we can struggle through to something.  Be prepared
for the fact that we will have a substantive discussion in
February on remedies, trying to link up all the discussion we've
had about culpability plus the discussion that other ways to
address questions of wrongdoing other than in the context of the
language of culpability and linking that up with the question of
remedies.  That's going to be a big part.  We are going to be
discussing experiments of opportunity and intentional releases at
the next meeting.  

          We will be discussing the work that's been done on
studies involving children and pregnant women, we think, we hope,
at the next meeting and in particular there linking it up with
the remedies question.  The children's project obviously most
prominently raises the question of whether there may be cases
where medical monitoring and follow-up may be appropriate as a
remedy, and so we'll try to bring all of that together in some
fashion with some examples coming from the research that was done
with respect to children.  

          And then we're just going to have lots of other things
but the big pieces at minimum will be culpability, intentional
releases, experiments of opportunity, the work on children
linking up to one dimension of the questionability for medical
follow-up monitoring stuff.

          MS. KING:  So remedies will come towards the end, I
hope.

          CHAIR FADEN:  In February?

          MS. KING:  Yes.  The reason I make that plea is -- I
don't know about everybody else but the discussions haven't yet
carried me to the point where I have developed any views about
remedies yet.  I don't know about other people but I know what a
remedy is and I know how to describe it and I know how to do all
that work, but that's not my critical question.  The question I'm
thinking about is when I think about remedies and where they
might be appropriate I need more facts and so the discussion on
some of the intentional releases and children would be very
helpful, even though the Remedy Subcommittee, of course, will
probably do work before the February meeting.  It would be
helpful to have more cases to have in your mind as we go through
the remedies portion, but don't make it so late that everybody is
too tired to even think about remedies.

          CHAIR FADEN:  Let's see.  That would be before lunch. 
I appreciate what you're saying.  And again, it's unlikely that
we're going to nail down the remedies issue.  We will have
hopefully more information from the oral history project,
obviously more updates from subject interview study as well as
from the protocol review project so all of that will be going on. 
If we have preliminary findings, particularly from the protocol
review project, we will start to share those by February so there
will be an awful lot happening in February and at least as much
happening in March.  It may be that a few chapters will be in
shape enough that the committee members will have seen them and
given comments back and revisions in time that we may have a part
of the meeting set aside for debate or discussion of chapter
drafts but that we don't know yet.  

          DR. THOMAS:  Two things.  I want to iterate slightly on
Pat's last comment.  I feel the need more than for facts than for
more analysis and conclusions specifically regarding the issue of
culpability.  We took the TBI discussion today as sort of a test
case to see, first of all, what further facts were needed and we
had a quick discussion along those lines before we were prepared
to make conclusions.  But we didn't round out that discussion
today with any conclusions.  I would hope there would be a block
of time where we might be able to revisit that and say, what do
we conclude about culpability?

          CHAIR FADEN:  Or anything else.

          DR. THOMAS:  And anything else, to try to draw some
conclusions to reach at least tentative closure on some of those
issues there.  That was one comment.

          The other is I feel strongly that our discussions will
be much more focused when we have draft chapters to react to, so
I really want to encourage the staff to try to reserve time -- to
do two things.  First of all, to reserve a substantial block of
time at the February meeting to discuss some of these chapters
that are at least going to be a second draft stage and second, of
course, to do the footwork that it takes to get drafts to that
stage.

          CHAIR FADEN:  It would be good if in the TBI one we
could do it in the context of chapter by chapter.

          MR. GUTTMAN:  It seems to me I've seen a number of
chapters and we've made commitments about certain other chapters
that we hope will be at least in the shape that they could be
discussed in a public meeting next time.  But I really want to
reserve a fair amount of time for that because this is the mode
that we ought to be moving into in our final meetings now.

          CHAIR FADEN:  That's right.  Okay.  It's 4:15.  Good
bye.  Thank you all very much.  Dan, can you officially close the
meeting.

          MR. GUTTMAN:  I hereby as the designated or
nondesignated federal official declare the meeting closed.  It's
compartmentalization responsibility.  I declare the meeting be
closed.

          (Whereupon, the meeting was concluded at 4:17 p.m.)