It’s a great honour to be able to give this lecture in this important context, so I would like very much to thank my hosts. This lecture is perhaps somehow different from what is typically presented in this context. I’m neither a physicist nor a physician, and I’m not an expert in radiological science; what I would be speaking about is the story, and more importantly, the ethics of the enterprise of human research on which advances in the radiological science, and indeed in many sciences, have so often depended.
As it has already been mentioned, I will be giving an account of an American Presidential Commission that I chaired; this Commission is called The Advisory Committee on Human Radiation Experiments.
I will describe the background, who we were, why we were created, what we were charged to do, and how we did it. I will tell you our critical findings and our principal recommendations, and if time permits, I will talk with you about the American President’s response to our applications.
First let me tell you about the story. In the autumn of 1993, in a very obscure local newspaper in New Mexico, a reporter whose name is Eileen Welsome published a series of investigations in which she claimed that there had been secret experiments conducted by the American Government in the 1940s in which unsuspecting hospital patients had been injected with plutonium.
She identified who these victims, as she called them, were, she interviewed their families and included photographs in the report; she essentially put the human faces in this accusation. For this report she subsequently won the highest prize for journalism in the USA, the Pulitzer Prize.
When the report came out, it captured the imagination of the national press. The stories appeared in the major newspapers of all the USA, and also in the TV news.
The accusations extended not only to these plutonium experiments, but also to claims that there had been experiments involving retarded children, pregnant women, and prisoners.
The response from President Clinton to decrease public outrage was to establish an independent National Commission, and this is the Commission I had the opportunity to chair.
President Clinton appointed fourteen members, four of whom had expertise in radiological science.
My other colleagues had expertise in Biostatistics, Epidemiology, Law, Ethics and History. The President gave us four charges.
The first was to investigate what had happened and, as Clinton described us, to tell the truth to the American public. Secondly it was assumed almost from the beginning that there would be some truth in these accusations, therefore we would uncover an unpleasant story. So we were asked to identify the appropriate moral standards for judging these events.
The essential question here was whether to judge the past by the standard of the past or the standard of the present, or indeed whether ethical standards can be permitted to change over time.
Our third task was essentially a public health task; we were asked to determine if there was any justification on medical grounds for notifying former subjects of radiation experiments so as to protect their health.
And finally President Clinton was concerned, and I believe rightly, that if we uncovered disturbing news, the American public would have feared that the same events worked on today, and that especially patients of hospitals would have feared that they were being the subjects of secret experiments and especially of secret radiation experiments.
Therefore he asked us to investigate not only the past but the present, and make a statement to the public about the likelihood that unethical experiments could still be going on.
But let me tell you a little bit about how we did it. We were essentially two Commissions in one; we were a Bioethics Commission and an Ethics Commission, but we were also what is called sometimes an ‘open commission’.
There had been very grave accusations against the Government and against the American scientific establishment, accusations of violations of human rights, and the concern was that no one would have trusted the results of a statement from the Government.
So we were established as an independent Commission with authority from the President to require from Federal agencies that they made available any document that might bear on our research.
We were to open the secret reports of Federal agencies to the American public. We had responsibility over six ministries: Ministry of Defence, Ministry of Energy, Ministry of Health and Human Services, Veterans Affairs, Space Agency NASA, and also the CIA. In addition to our authority to demand from these agencies that we reviewed the reports, the agencies were also required to respond immediately to any request that we might have made for the declassification of secret documents.
All together we collected over 4000 documents, and one thing that made me particularly proud was that we were responsible for the declassification of literally thousands of documents of the Cold War.
In addition to this massive search for documents, we also conducted 20 open public meetings in which we collected testimonies from over 200 witnesses in all the USA who claimed to have knowledge about radiation experiments, including former subjects and their families.
The time we were asked to investigate went from President Roosevelt to President Ford.
We were also, as I’ve already mentioned, asked to investigate the current state of USA research involving human subjects.
To conduct this investigation, we interviewed 900 cancer and heart patients – half of whom were involved in radiation therapy – about their involvement in this research.
These were patients from five different regions of the USA, from 16 different hospitals, and we checked their understanding against the medical research reports.
We also took a random example on 125 experiments currently being funded by the American Government; about half of these experiments involved the exposure of human beings to ionizing radiation.
Here we reviewed all the documents that were available about these experiments.
All together we had 18 months. Then we published the final report that I would have brought with me but it was too heavy (900 pages long).
As you might imagine, we’ve had an enormous task; in order to make our project manageable, we adopted the strategy of identifying case studies: Several of these case studies pursued the accusations that had been made in the press; so one case study investigated plutonium experiments, one case study investigated radiation experiments in which the subjects were children, another radiation experiments in which the subjects were prisoners, and the other four involved radiation experiments in which the subjects were cancer patients exposed to total-body radiation.
Some of our studies, however, didn’t focus on classic human experiments. We were also requested by the President to investigate whether there had been accusations of secret intentional releases of radiation into the environment, or espionage experiments. We also investigated the experiences of what we call in the USA the Atomic Veterans; these were soldiers who in some respect participated in the atomic bomb testing, primarily in the 1950s. We also investigated the experience of the USA’s involvement in testing in the Marshall Islands in the Pacific, and also the experience of miners in Uranian mines in the South West of the USA in the 1950s and 1960s. Now let me tell you something about our findings.
First with respect to human radiation experiments in the past.
We concluded that generally radiation research was not different in its effects from other areas of medical research involving human subjects, with a few important exceptions.
The number of the experiments involving human subjects and exposure to ionic radiation numbered in ten thousands; most of these experiments were not connected with national security or natural concerns, and involved radioactive tracers administered in amounts that are similar to those that would be acceptable today, with one exception; the doses that were permitted with children were higher than we would allow now, and are associated with the increases in the potential lifetime risk of developing thyroid cancer.
We can’t conclude that no one was harmed by the experiments.
Finally, on the importance that ethics should have had on these experiments, it was very traumatic for us to know that even in the 1950s the Atomic Energy Commission, our Departure of Defence and our principal research institute, called The National Institute of Health, recognized that research should proceed only with the consent of the human subjects, nevertheless there was a very small evidence that consent had been obtained from patients when they were used as subjects.
We were especially disturbed about research that was not therapeutic in any respect; by this I mean research that even at that time offered no prospect of medical benefit to the subject. In such research, even at that time it would have been unethical in terms of the rules of the American Medical Community to conduct such research without express consent.
And yet, this kind of non-therapeutic research was not only conducted on patients without their acknowledge nor their consent, but in a few cases there was a deception to patients and their families about the purpose of the research.
Now I should emphasize that we had substantial historical evidence that this kind of deception occurred not only in radiation research, but more generally in medical research at that time.
We were also very concerned about the selections of subjects for this research, as far as we could discover that research in which the subjects were children was not connected with military objectives.
Much of this research in fact was directed to objectives in nutrition. What disturbed us was not the purpose but the fact that the children that were the subjects were institutionalized, mentally retarded children and children abandoned by their parents.
The rational for selecting these children was that they needed a group of children whose dignity could be controlled, so that the serial could have tracers. However, one of my colleagues said: “Why didn’t they select children institutionalized in selected private schools?” As the research was so beneficial, the children in this research were offered incentives for the multiple blood sample that they experienced.
And these incentives were very impressive; they were offered a chance for a trip to the beach which was something that they had never got a chance to do. They were told they would join in a science club, where they would get special presents.
So although doses were very low, relatively speaking, the concern about ethics come from the selection of the powerless, and the misrepresentation to the children and their parents of what was going on.
Let me quickly tell you about the intentional release of radiation in the environment. When we were commissioned, it was suspected that perhaps there had been six or seven of these releases from the State of Washington, in which there is a very important factory which produces material that supports weapons. In fact there were several hundreds of such releases, but they were not for the purpose of studying the effects of radiation on human beings.
Rather, as I mentioned earlier, their purpose was to establish whether we could detect what the Soviets were producing; if we knew how much we were releasing we could, by spying planes, correctly detect the amount and correctly infer production of the plants in the Soviet Union.
We are currently engaged in carrying out a dose reconstruction research. It’s extremely unlikely however that members of the public were harmed as a consequence of these releases; it must be remembered that these plants continued in their release to contaminate the environment.
What was deeply disturbing, however, was the fact that these releases were not only being conducted secretly, which might have been justifiable at that time, but that they were being kept secret for forty or fifty years, despite repeated attempts by the local community to establish what had happened. Indeed, we concluded that the secrecy with which some of these human radiation experiments and also these intentional releases were conducted was responsible for most of the serious negative consequences in this period of the American history.
And these consequences were primarily the distrust and suspicion that they engendered among the American public.
When we uncovered that in most cases this secrecy was not required for national security, but rather was maintained to prevent legal consequences and also to prevent bad press, it only added to a sense of scepticism and distrust, and this distrust is a great concern to all of us who believe in the importance of the advance in science.
Let me say a few words about what we learned on the current state of research involving human subjects.
First of all we found little difference about radiation research, compared with other research involving human subjects, and we found evidence that much research is today conducted in accordance with the highest ethical standards but, as it is always the case, we also found evidence of a significant moral concern. The term we used was ‘serious deficiencies’, and it took our commission about twenty hours of deliberation to select the right term.
Primarily, these concerns were of two types.
First we found evidence of research involving incompetent adults in medical research, in which they wouldn’t benefit medically, with no clear understanding as to whom, if anyone, should have been allowed to authorize such research.
A typical example would be the research into Alzheimer’s disease, in which the subjects were involved in imaging studies, but were not able themselves to understand what was happening, and being closed in an imaging machine was for some of these patients very terrifying, even though they run essentially no medical risks, and we didn’t have the answer.
We were concerned that we needed special rules and protections.
The other area of concern involved patients that were very seriously ill, essentially patients who were at the end of their life, for whom there was not any known medical treatment, involved in very early studies of medical intervention, which very extremely unlikely to help them.
But these patients were so desperate that we were concerned that they wouldn’t understand that the research would have benefited patients that would have followed them, but not themselves personally.
Let me very quickly summarize our recommendations.
First, and this was really unprecedented, we recommended that Clinton officially apologized to the family members of some of these experiments, the ones who had supported the worst injustices from a moral standpoint; and indeed the President did make a public and personal apology.
And we also recommended that the American Government provided a financial compensation to a few of these families.
We also recommended that our laws be emended so as to restrict even further the authority of our Government to conduct secret human experiments.
This is still permitted under the American Law; however the President has responded by adopting most of our recommendations about the secrecy.
We also made several recommendations with respect to the policy of human subjects research, with a particular focus on research conducted in the military and private industries field.
Research conducted in the universities is also in need of reform; however at least in universities and in National Research Institutes we have federal laws that are somehow to protect human subjects.
These laws aren’t applied to private industries in most cases.
However, and I conclude with this, we were after all a historical commission; a commission looking at history is especially obliged to learn from history.
As I’ve mentioned to you, there were already regulations and directives in the 1940s and 1950s and 1960s at the Defence Department and the Atomic Energy Commission requiring consent, but these requirements were never followed.
We have learned from this story that the Government can write the most elaborate regulations, but there are human limits that must be set by ethics; and a good ethics in a professional context most come from within the profession, and so our major recommendation had to do with changing education and the incentives for scientists and medical investigators, so as to make ethics central to their profession.
We had some success from these recommendations, but we still have a long way to go.
Thank you very much.
Ruth R. Faden
Philip Franklin Wagley Professor
of Biomedical Ethics and Director
The Bioethics Institute
Johns Hopkins University
Senior Research Scholar
Kennedy Institute of Ethics
PARTECIPANTI ALLA TAVOLA ROTONDA
(Bioethics Institute, Johns Hopkins University, Baltimore)
(Direttore Generale Ospedale “Eugenio Morelli”di Sondalo)
(Coordinatore Consulta Donne Radiologhe, Primario Radiologia Pio Albergo Trivulzio, Milano)
(Product management and technology assessment, Siemens, Erlangen)
(Responsabile Tecnologie Avanzate, apparecchiature di radioprotezione)
Maria Luisa Biazzi
(Professore di Fisica Medica, Università di Pavia)
(Direttore Leadership Medica e Leader for Chemist),
“The Advisory Committee on Human Radiation Experiments”
Ruth Macklin, Ph.D.
Professor of Bioethics
Department of Epidemiology & Social Medicine
Bronx, New York Philip K. Russe, M.D.
Professor, Department of International Health
Johns Hopkins University
School of Hygiene and Public Health
Lois L. Norris
Second Vice President of Omaha National Bank and Omaha National Corporation (Retired)
Omaha, Nebraska Mary Ann Stevenson, M.D., Ph.D.
Assistant Professor of Radiation Oncology
Joint Center for Radiation Therapy
Harvard Medical School
Nancy L. Oleinick, Ph.D.
Professor of Radiation Biochemistry
Division of Radiation Biology
Case Western Reserve University School of Medicine
Cleveland, Ohio Deputy Chief
New England Deaconess Hospital
Department of Radiation Oncology
Henry D. Royal, M.D.
Professor of Radiology
Associate Director: Division of Nuclear Medicine
Mallinckrodt Institute of Radiology
Washington University Medical Center
St. Louis, Missouri Duncan C. Thomas, Ph.D.
Director, Biostatistics Division
Department of Preventive Medicine
University of Southern California School of Medicine
Los Angeles, California
Reed V. Tuckson, M.D.
Charles Drew University of Medicine and Science
Los Angeles, California Ruth R. Faden, Ph.D., M.P.H.-Chair
Philip Franklin Wagley, Professor of Biomedical Ethics and Director
The Bioethics Institute
Johns Hopkins University