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Office of the Press Secretary

For Immediate Release March 28, 1997
                           PRESS BRIEFING BY 

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 Furnald 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