THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release March 28, 1997
PRESS BRIEFING BY
SECRETARY OF ENERGY FEDRICO PENA,
ASSISTANT SECRETARY OF ENERGY TARA O'TOOLE,
AND ACTING ASSOCIATE ATTORNEY GENERAL JOHN DWYER
The Briefing Room
11:10 A.M. EST
MS. GLYNN: Good morning, everybody.
Today we have a human radiation report here. To brief is Secretary
Federico Pena; Tara O'Toole, who is the Assistant Secretary of Energy
for Environment, Safety and Health; and John Dwyer, the Acting Associate
Attorney General.
SECRETARY PENA: Thank you very much.
Good morning, everybody. Dr. O'Toole, please come up, and John,
join me here to my left and right.
Let me begin by reading a statement
from the President and then I have an opening comment. I'll introduce
Dr. O'Toole and John to make some comments.
The President today has issued the following
statement:
When I accepted the Advisory Committee's report in
October of 1995, I promised that it would not be left on the shelf to gather dust. I
made a commitment that we would learn from the lessons
the committee's report offered and use it as a road map
to lead us to better choices in the future. We have actively worked
to respond to the Advisory Committee's recommendations to make
the record of these experiments open to the public, to improve ethics
in human research today, and to right the wrongs of the past.
The report we are releasing today is an important
milestone in our progress, but we are by no means
at the end of our journey. Much work remains to be done. I am confident
that all of us -- the eminent committee that produced the original
report, the federal officials who worked so hard to support the
committee's efforts, and most importantly, the citizens of this
great country from whose experiences we have learned so much --
can together help ensure a better world for our children.
Ladies and gentlemen, in October of
1995, the President committed to take action to right the wrongs of past
governmental secretive radiation experiments on unknowing citizens.
He directed eight governmental departments and agencies to respond
to the recommendations of the Advisory Committee on Human
Radiation Experiments. I am pleased to announce on behalf
of President Clinton important milestones in the government's continuing
efforts to respond to the recommendations of the Advisory Committee.
Today's announced actions are designed
to increase public trust, to ensure public accountability, and
demonstrate this administration's continuing commitment to openness
in government.
Our work to uncover the truth began
three years ago. Already, federal agencies have made available and
declassified millions of pages of documents. We've responded
to thousands of inquiries. My own agency, the Department of Energy,
has led this unprecedented effort. And let me say on a personal
basis, I am very proud to continue the very important legacy that
my predecessor, Hazel O'Leary, started as the Secretary of Energy,
and today we're continuing on that important work.
Compassion and concern are at the core
of our response to human radiation experiments -- compassion for
those who may have been part of unethical experiments in the past, and
concern to ensure that any future subjects of human research are fully
protected.
Today, I am announcing new commitments
in all of these areas, and they are detailed in a document that we're
releasing today, which is entitled "Building Public Trust."
And I hope you all have a copy of the document; you'll soon get it.
These commitments and actions were directed
by the President to respond to the recommendations of the
Advisory Committee on Human Radiation Experiments. First, the President
has signed a directive to strengthen the rights and protections
of people who might, in the future, participate in secret government-supported
research. Secondly, the administration is proposing
legislation that will compensate hundreds of miners who suffered lung
cancer from working in uranium mines who would not otherwise
be compensated under current law. And, finally, I am pleased to announce
that the Clinton administration has now essentially settled the compensation
claims of all the known individuals for whom the Advisory Committee
recommended compensation.
When he accepted the report of the Advisory
Committee the President stated, "Our greatness is measured
not only in how we do right, but also in how we act when we know we've
done the wrong thing; how we confront our mistakes, make our apologies
and take action." We stand here today to make our government
accountable to our citizens and to assure the American people of
our commitment to do the right thing.
I would like to personally thank the
leadership and the staff of the eight federal agencies and the departments,
including my own Department of Energy, who participated in this
effort. Today's report is a product of their combined efforts.
Let me also say that I understand that
Senator Hatch, who authored the original legislation that compensates
uranium miners, along with Senator Domenici and Congressman
Markey, will all be working with the administration to revise that
legislation, hopefully get it passed as soon as possible. I also
want to acknowledge the leadership of Senator Glenn on the
question of protection of human subjects.
At this time let me introduce Dr. Tara
O'Toole, who is the Assistant Secretary of Environment, Safety and
Health from the Department of Energy. And after she speaks, John
Dwyer, Acting Associate Attorney General from the Department of
Justice -- they're going to give you more detail and hopefully participate
in the question and answer period.
Q Can you say whether anything like
that is going on now, anything tantamount?
SECRETARY PENA: Well, Dr. O'Toole will
answer that specifically, but the interagency group that has
been working on this effort to date has not found any of that work ongoing.
But to make sure, annually there will be a report -- the first
due in about nine months -- from all government agencies, which will
be made public, specifying the extent to which any of these kinds
of secret experiments are going on. But to the best of our
knowledge today, the interagency group has found that this is not
going on in the government.
Q How much was the compensation that
you settled? And how much is it estimated that the miners would
be able to collect
SECRETARY PENA: Let me answer that
question in two ways. First of all, let's take the 17 individuals
who are being compensated essentially for plutonium injection;
one of them had uranium injections. That total amount is approximately
$6.5 million for all the individuals. As respects the uranium
miners, there are approximately 600 uranium miners, and that cost will
be approximately $50 million, which will be paid over a 15-year period.
But again, the attorney who was working
on that is here; he can give you more detail. And Dr. O'Toole can
answer your questions more specifically.
Q Secretary Pena, almost all these
people are dead, aren't they -- the people receiving compensation?
SECRETARY PENA: This is mostly for
their families; that is correct.
Q Are any still living?
DR. O'TOOLE: The answer is yes.
Q Do you know how many?
DR. O'TOOLE: I believe two are still
living.
Q Two of the 17.
Q What about the miners?
DR. O'TOOLE: Let's be clear. Are you
talking about the plutonium experiment subjects?
Q The 600 miners who are also mostly
dead, too, aren't they?
DR. O'TOOLE: A proportion of them are.
The 600 number is an estimate based upon what we expect the new
proposed legislation will cover. Perhaps if I could give my remarks that
would answer some of your questions.
Thank you, Mr. Secretary.
Well, as President Clinton and Secretary
Pena have said, the government's effort to tell the story of human
radiation experiments, to right past wrongs associated with
those activities, and to protect all human subjects involved in research
is an ongoing effort. Today's report is an important milestone
in this effort. But a number of actions have already been taken by
all of the agencies involved, and what I am going to do today
is highlight two, and Mr. Dwyer will speak to a third response of the
government to the 18 recommendations from the President's Advisory
Committee on Human Radiation Experiments.
The Advisory Committee's first recommendation
pertained to compensation. And the committee recommended that
the government compensate people when they had been the subject
of radiation experiments, and when efforts made by the government
to keep secret those experiments for purposes of avoiding embarrassment
or liability to the government.
As Mr. Pena has announced, DOE and the
Department of
Justice have essentially reached settlement on compensation
for all
16 of the families of subjects who were involved
in the plutonium
injection experiments. There are two more subjects
who were involved
in plutonium injection experiments; one family of
those two remaining
subjects does not wish to participate and we have
been unable to
track down the remaining individual or his or her
family.
There is also a settlement in the case
involving uranium
injection which met the criteria for compensation
set forth by the
Advisory Committee.
As regards classified human subjects
research, as
Secretary Pena said, our interagency working group,
which did include
eight agencies, including the CIA, the Department
of Defense and the
Department of Energy, are unaware of any secret,
classified
experiments of any sort involving human subjects
research going on
today. Nonetheless -- and the Advisory Committee,
made the same
findings. They were unaware of any existing classified
research
involving human subjects in radiation experiments.
Nonetheless, the Advisory Committee
did recognize that
it was in the nation's interest at times, possibly,
to conduct
classified research where important national security
matters were
involved. And the Advisory Committee made five recommendations
about
carrying out such classified research on human subjects.
The committee recommended first that
informed consent
never be waived in such research; secondly, that
the sponsoring
agency of the research be clearly identified to the
prospective
subjects; thirdly, that the subject understand that
the experiment is
classified; finally, that permanent records be kept
of all classified
experiments; and, finally, that the government move
to improve the
independence of review of such proposed classified
research.
The government has accepted in total
and moved to
implement all of the first four recommendations.
And the President
has directed all of the federal agencies to jointly
propose
amendments to the common rule which currently governs
human subjects
research to incorporate these recommendations.
The government also agrees with the
call for a special
review process to apply to classified human subjects
experiences, and
we have proposed the following procedure. First
of all, all internal
review boards -- these are the groups that oversee
proposed human
subjects research, whether classified or not -- but
all internal
review boards involving classified research will
include one
nongovernment member at least. Any member of such
IRBs, as these
internal review boards are called, may appeal directly
to the head of
the agency if he or she disagrees with the judgment
of the IRB to go
forward on a classified human subject experiment,
and may, if he so
desires, appeal further to the President's Advisor
for Science and
Technology.
Finally, the government will keep permanent
records of
all classified human subjects experiments and declassify
them as soon
as possible. And finally, as Mr. Pena said, to make
sure that in the
future there is absolutely no doubt about whether
classified human
subjects experiments are going on, the President
has directed each
agency to report annually and to make public the
number of such
experiments that the agency is conducting and the
number of subjects
involved in such experiments.
With that, let me turn it over to Mr.
Dwyer, who is
going to make some remarks regarding the proposals
for the uranium
miners, and then we'd be happy to take questions.
Q Before you do, can I just get a
clarification from
you? When you listed all the precautions the government
is now going
to take, vis-a-vis classified human experiments,
you're not limiting
those to radiation experiments --
DR. O'TOOLE: That's correct. All classified
Q -- genetic, bio, et cetera?
DR. O'TOOLE: That's correct.
MR. DWYER: Thank you, Secretary Pena
and Dr. O'Toole.
I just have a very brief statement. I'm happy to
announce today that
the administration is proposing legislation that
will address a
number of shortcomings in the Radiation Exposure
Compensation Act of
1990 that were identified by the Advisory Committee
in the
administration's own review.
The legislation will modify the present
compensation
criteria for uranium miners and other eligible claimants
in a number
of important ways. We will, thereby, further the
intent of the
original 1990 act to provide compassionate payments
to individuals
who were exposed to radiation as a result of the
federal government's
nuclear weapons testing program during the Cold War
era.
In 1990, Congress passed the Radiation
Exposure
Compensation Act to provide compensation to certain
groups who were
exposed to radiation during this period of time.
The statute
recognizes three groups eligible for compensation.
The first group,
the so-called downwinders, are individuals who lived
a specified
duration of time in certain counties downwind of
the Nevada test site
during period when above-ground nuclear tests were
conducted.
The second group, the on-site participants,
are
Department of Defense and Department of Energy personnel
and
contractors physically present at one of the federal
government's
nuclear weapons testing sites during an atmospheric
detonation of a
nuclear device.
And the third group are individuals
who were employed in
underground uranium minds in the states of Arizona,
Colorado, New
Mexico, Utah and Wyoming, and who suffered or suffer
from either lung
cancer or one of a number of nonmalignant respiratory
diseases.
Recently the President's Advisory Committee
criticized
certain provisions in RECA governing compensation
for uranium miner
claimants as understating the risks experienced by
the uranium
miners. In response to this recommendation, the
Department of
Justice and other federal agencies undertook a review
of the RECA
provisions relating to uranium miners.
This review, which employed updated
epidemiological data
on uranium miners and newer analytical methods has
led the
administration to conclude that, indeed, the present
exposure
criteria understate the risk to miners of contracting
lung cancer as
a result of radiation exposure. As a consequence,
we believe the
present criteria have the unfortunate and unjust
effect of denying
compensation to many miners who are subject to considerable
risk of
lung cancer from exposure to radiation and who, in
fact, later
developed lung cancer.
Additionally, through our experience
administering the
act, the Department of Justice has identified a number
of statutory
provisions relating to the downwind and on-site participant
populations that should be modified to promote just
compensation.
The proposed legislation is designed
to remedy the
shortcomings. I want to briefly mention the two
most significant
changes. First, the proposed bill would significantly
amend the
statutory provisions that govern compensation to
uranium miners by
incorporating new compensation criteria to reflect
the latest
scientific and other information available to us.
The first new set
of eligibility criteria will take into account not
just the amount of
radiation exposure, but also the date the disease
manifested itself
and the amount of time that has passed since the
miner last worked in
the mines. These changes will allow more accurate
assessments of
whether the radiation exposure was the likely cause
of the lung
cancer.
A second set of eligibility criteria
will allow miners
to use, for the first time, duration of employment
in the mines as a
surrogate for actual exposure to radiation. This
will make the
process significantly less burdensome for many miners
as they apply.
The proposed legislation would also
add a new set of
eligibility criteria that would provide partial compensation
to some
miners who presently do not qualify for the full
compensation amounts
specified in the act, but whose exposure to radiation
was sufficient
to significantly elevate their risk of lung cancer.
These new
eligibility criteria would take into account known
uncertainties in
the underlying data, principally uncertainty as to
the accuracy of
historical radiation measurements, and resolve those
uncertainties in
favor of the miner claimants. The proposed bill
would, therefore,
provide partial compensation to uranium miners whose
exposure, if the
claimant is given the benefits of the known uncertainties,
is the
most likely cause of their lung cancer.
We believe that this is a significant
step forward in
the administration of the Radiation Exposure Compensation
Act and
look forward to working with Congress to ensure its
speedy passage.
Thank you.
Q Secretary Pena, were all of the
human guinea pigs
of the past -- all this knowledge was unbeknownst
to them? Were they
just deceived? And who is responsible? Why were
they deceived?
SECRETARY PENA: All right, let me answer
the question
generally, and let me have Dr. O'Toole answer your
question more
specifically. We are talking about several thousand
experiments, and
we cannot give you an exact and precise number because
of the
condition of certain records. The overwhelming majority
of those
were not classified. A small proportion of those
were actually
classified. And generally speaking, for the classified,
there was
very little information provided to the individual
subject to the
injections.
And that is why the Advisory Committee
found that, in
particular, those 18 cases were so egregious that
we should find a
way to compensate. And we have done that, essentially,
with the
exception of one family and one that we're having
trouble locating.
Please, let me have Dr. O'Toole add
to that.
Q The family just doesn't want to
settle, they want
to sue or --
DR. O'TOOLE: No, they do not want to
participate in any
compensation scheme.
If I might clarify the universe of human
radiation
experiments, there were indeed thousands of experiments
carried on
which meet the definition -- which is quite broad,
intentionally --
set forth in the charter for the Advisory Committee.
These
experiments were, for the great preponderance of
experiments, ethical
and appropriate, and were not secret.
They fall into three cases, three categories.
There was
a large body of experiments that was conducted to
help us better
understand normal metabolism and the biological processes
of disease.
There was also a series of experiments carried out
to try and
understand how radiation might better be used to
diagnose and treat
disease, primarily cancer. And, thirdly, there was
a smaller set of
experiments that involved the, as in the plutonium
injection
experiments, efforts to understand the consequences
of radiation
exposure in human subjects in order to set standards,
principally for
workers engaged in the war effort.
Now, the Human Radiation Advisory Committee,
as I said,
found that most of those were neither ethical, nor
harmful. It is a
very small portion of that universe that comprises
the troublesome
experiments.
Q But they knew what was --
DR. O'TOOLE: There are -- the answer
to that is
sometimes. What the Advisory Committee found was
that physicians
carrying out experiments on healthy subjects, even
back in the '40s
and '50s, almost always informed those subjects that
they were part
of an experiment. However, in the past, and really
even as recently
as the late '60s and early '70s, doctors did not
necessarily on a
regular basis inform patients whom they were treating
for disease,
possibly with unconventional methods, that they were
part of a
research protocol. That was not made as clear as
it would be today.
Again, the professional morays were looser than is
now the case since
the passage of the common rule.
Q Well, what about the doctors that
they knew they
were doing something wrong -- are there any of them
around? What's
going to happen to them?
DR. O'TOOLE: I'm sorry, could you repeat
the question?
Q The isolated cases, you say, where
they did know
what they were doing was wrong, was going to harm
the patient -- are
any of those guys that managed these experiments,
the doctors, are
they still around? Is anything going to happen to
them?
DR. O'TOOLE: I don't think the -- the
Advisory
Committee did not find any experiments where the
doctors knew they
were going to harm the patients. There were experiments,
and I think
the only one of I know of offhand -- there may have
been two or three
that were suggested in the report -- were the Cincinnati
experiments,
where the committee found that the patients had been
led to believe
that the treatment was more conventional than was,
in fact, the case,
and that there was a greater probability of benefit
than was probably
justified.
Q The Advisory Committee refers to
52 other people
that should be compensated; says that there are three
sets of people
that should be compensated, one set of 18, which
we've talked about,
and two sets totalling 52 people whose identity is
not known. And
could you elaborate on who these 52 -- what kind
of experiments --
DR. O'TOOLE: Yes. What the committee
did was follow a
very classic public health practice; that is, they
set the criteria,
the ethical criteria that they deemed appropriate
for compensation,
and then they looked at the experiments to see which
met those
criteria. Obviously, they had to sample from the
universe of
experiments.
They did find experiments -- these were
not classified
experiments, for the most part, they had been published
in the
scientific literature -- that seemed to meet those
criteria and that
were worthy, they thought, of further investigation
and possibly
compensation.
The problem is this; that the tradition
in science is
that you publish results without identifying the
subjects by name.
And we have been unable to track back through existing
records to
identify all of those 56 individuals. Some of the
cases that are
mentioned among that group are in litigation now.
Q What kind of experiments did those
involve?
DR. O'TOOLE: They generally had to
do with the
classifications that I mentioned -- experiments where
the treatment
was portrayed as being either more conventional than
was, in fact,
the case -- it really was experimental treatment
without any clear
evidence that it would produce benefit to the patient
-- and where
the evidence that benefit was going to be forthcoming
was not
adequate.
Q What happened to the subjects of
the experiments, I
believe, near Boston, where there were retarded children
used for
certain radiation?
DR. O'TOOLE: The Frinald School (phonetic)
experiments,
where children at a school were fed cereal that had
trace amounts of
radioisotopes in them. I believe those are under
litigation now.
Q How many cases are currently under
claim or
litigation that haven't been resolved? Not just
in that example, but
all these experiments.
MR. DWYER: I don't actually know the
total number. I
know there are at least four pending litigations,
piece of
litigation, several of which involve more than one
plaintiff. I
don't have a total number.
Q Where do the TBI experiments fall
in this? I mean,
there are people who are -- the Advisory Committee
was not clear on
whether these people should be compensated; it said
that they should
be looked at. How does the administration respond
to that?
DR. O'TOOLE: We are going to use the
committee's
criteria for judging those cases.
Q And so what do those people do?
Do they need to go
through the courts then to follow the court process?
DR. O'TOOLE: Do you want to speak to
that, John? We
are using the federal torts claims act because it
is a known
procedure and it was faster than setting up a whole
new process. We
are working to streamline that procedure using, for
example, dispute
mediation methods as necessary. And those cases
are in litigation.
Q Does the report deal at all with
the testing that
was done on Marshall Island or in the Pacific Islands?
DR. O'TOOLE: Yes. Yes, the Advisory
Committee
suggested that the Department of Energy take another
look at the
program that we had been running for many years to
monitor and
provide medical care for those citizens of the Marshall
Island that
were exposed to radiation in the course of the South
Pacific atomic
bomb tests. And they made several specific recommendations
about how
to proceed. What we are doing is the following:
The Department of
Energy, the Department of Interior, and the government
of the
Republics of the Marshall Islands are in negotiations
now. We have
committed fully to making the Marshallese much more
active
participants in determining how those monitoring
programs will be
carried out and where they will be focused. We are
essentially
following all of the committee's recommendations.
Q Have you reached a conclusion about
the extent of
damage to human health from experiments?
DR. O'TOOLE: The Advisory Committee
looked at those
experiments that they thought were most likely to
have been of high
risk. What the Advisory Committee has said is that
they do not think
that much, if any, harm was done as a consequence
of these
experiments, although clearly ethical wrongs were
committed by the
government.
Q Could you explain what human experiments
are now
underway and why any of them in this post-Cold War
era have to be
classified?
DR. O'TOOLE: There are no classified
human radiation
experiments underway as far as the interagency working
group could
determine.
Q How about of any kind?
Q Any kind. I mean, you gave some
criteria, so that
must mean something.
DR. O'TOOLE: There are no classified
experiments
involving human subjects underway as far as the interagency
working
group could determine, whether they involve radiation
or anything
else.
Q Just so I'm clear, there is a group
of experiments
that have been identified as sort of morally wrong
because they were
classified, and there is another group of experiments
that the
government says, well, maybe these weren't the greatest,
but we're
going to litigate these cases, we're not going to
settle these cases
because we think that they were done appropriately?
MR. DWYER: The Advisory Committee,
putting aside the 18
plutonium injection cases, identified several other
experiments that
took place which they felt we need further fact-finding
in. And so,
in fact, some of those cases are currently in litigation;
some of
them are in the administrative claim process at the
Department of
Energy, and we are developing further facts. We
will ultimately
resolve those cases in a manner consistent with the
President's
report and the recommendations that he has adopted
from the Advisory
Committee report.
Q You don't have any sense of how
many individuals?
You said four cases, but some of them have multi-individuals.
Are we
talking about hundreds, dozens? How many people
are we talking
about?
MR. DWYER: It's not hundreds, the four
cases that I
mentioned. It's somewhat difficult to identify that
universe because
part of the fact-finding is to determine, in fact,
whether or not the
government had any involvement with these various
experiments. I can
-- afterwards I can provide you a total number of
the four or five
cases that I identified earlier.
THE PRESS: Thank you.
END 11:40 A.M. EST
|
|