DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB I-1 ....DRAFT . FOR DISCUSSION PURPOSES ONLY..... MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: January 10, 1995 RE: Additional Documentation on the Plutonium Injection Experiments and Other Metabolism Experiments with Long-lived Isotopes Conducted by the Manhattan Engineer District EXECUTIVE SUMMARY Advisory Committee staff are reviewing a collection of documents relating to the Manhattan Engineer District's human metabolism studies with long-lived radioisotopes, including plutonium, uranium, and polonium. The documents show that (1) there was no absolute requirement set forth in the experimental protocol for the University of Rochester plutonium injections that the subjects be terminally or even chronically ill patients;1 [In the classic 1950 paper summarizing the experiment (see Briefing Book #2, Tab M), Langham et al. stated: "As a rule, the subjects chosen were past forty-five years of age and suffering from chronic disorders such that survival for ten years was highly improbable." ("Distribution and Excretion of Plutonium Administered Intravenously to Man," September 20, 1950, p. 10) In a 1956 presentation, evidently the first public statement by Langham on the experiment, he stated: "Fifteen hopelessly sick individuals were given very small single injections of plutonium intravenously. . . ." (Proceedings of the Second Annual Meeting on Bio-assay and Analytical Chemistry, October 11 and 12, 1956, p. 80)] (2) it was not until the later phase of the Rochester part of the experiment, after several injections into non-terminal patients, that the first terminal patient was injected and further injections into terminal patients were discussed; (3) a draft version of the 1950 plutonium report states that one patient at University of Rochester was misdiagnosed, and that a deliberate choice was made by the experimenters in the planning stages of the University of Rochester experiment to choose patients with non-malignant diseases in order to more closely model normal human metabolism (there were, in fact, no subjects with malignant diseases chosen at Rochester); (4) in the case of the 1 plutonium injections at University of Rochester, patients were not told that they were receiving radioactive material, and in the case of the uranium injections, one document indicates that the six subjects (all non-terminal patients) were probably not informed as to the nature of the injections; (5) as previously identified documentation has shown, the decision to prolong classification of the plutonium injection study was at least partially driven by liability and public relations considerations; and (6) the exhumation study undertaken by Argonne Center for Human Radiobiology starting in January 1973 was not brought before the Argonne Human Use Committee until November 1973, at least partially for public relations reasons. * * * * * Attached is a document chronology and summary written by Advisory Committee Staff (Attachment 1), providing brief descriptions of each document in the collection, as well as descriptions of a few key documents previously identified which provide context for the new material. Also attached are several key documents which have been selected from the collection. I. DOCUMENT ENTITLED "REVISED PLAN OF 'PRODUCT' PART OF ROCHESTER EXPERIMENT"2 [Wright Langham, "Revised Plan of 'Product' Part of Rochester Experiment," ACHRE No. DOE-121294-D.] Attachment 2 is the experimental protocol for the University of Rochester plutonium injections. This revised protocol was written as a result of a meeting on September 5, 1945, held in Rochester at the request of Colonel Stafford Warren, between Dr. Wright Langham of Los Alamos Scientific Laboratory, members of the medical staff of the Rochester Metabolism Ward, and Captain Bryan representing Colonel Warren's office. On the selection of human subjects, Dr. Langham writes: The selection of subjects is entirely up to the Rochester group. At the meeting it seemed to be more or less agreed that the subjects might be chronic arthritics or carcinoma patients without primary involvement of bone, liver, blood or kidneys. It is of primary importance that the subjects have relatively normal kidney and liver function, as it is desirable to obtain a metabolic picture comparable to that of an active worker. Undoubtedly the selection of subjects will be greatly influenced by what is available. The above points, however, should be kept in mind. (p. 2) 2 II. DOCUMENTATION REGARDING THE FIRST TERMINAL PATIENT IN THE HP SERIES Attachment 3 is a series of early 1946 correspondence between Dr. Samuel Bassett at University of Rochester and Dr. Langham regarding subject Hp 11. ("Hp" refers to the series of plutonium injections at University of Rochester and to the one known injection at Oak Ridge, Hp 12.) This documentation indicates that it was not until after several non-terminal patients were injected at Rochester that the first terminal patient was injected and further injections into terminal patients (and higher doses for terminal cases) were discussed. In the March 13, 1946 letter to Dr. Bassett, 3[Wright Langham to Samuel Bassett, March 13, 1946, ACHRE No. DOE-121294-D.] Dr. Langham writes: Your letter of February 27 regarding Hp 11 was startling, to say the least. . . . In case you should decide to do another terminal case, I suggest you use 50 micrograms instead of 5. This would permit the analysis of much smaller samples and would make my work considerably easier. I have just received word that Chicago is performing two terminal experiments using 95 micrograms each. I feel reasonably certain there would be no harm in using larger amounts of material if you are sure the case is a terminal one. Dr. Bassett responds in his March 27 letter to Dr. Langham:4 [Samuel Bassett to Wright Langham, March 27, 1946, ACHRE No. DOE-121294-D.] Hp 11--This case did turn out to be terminal, but at the time I started the experimental period, there was sufficient uncertainty regarding the outcome to make me feel that the dose should be within the range of tolerance. . . . The larger doses that you mention, particularly 50 micrograms, might be given if a suitable opportunity occurred and if you are very anxious that I should carry it through, I will see what can be done. 3 III. DOCUMENT ENTITLED "EXCRETION OF PLUTONIUM ADMINISTERED INTRAVENOUSLY TO MAN. RATE OF EXCRETION IN URINE AND FECES WITH TWO OBSERVATIONS OF DISTRIBUTION IN TISSUES" 5["Excretion of Plutonium Administered Intravenously to Man. Rate of Excretion in Urine and Feces with Two Observations of Distribution in Tissues," ACHRE No. DOE-121294-D.] Attachment 4, a draft version of part of the classic 1950 plutonium report, was apparently written by Dr. Bassett (see note to Dr. Langham on page 5a). This draft contains information regarding the misdiagnosis of one patient and regarding subject selection (i.e., that patients with non-malignant diseases were chosen as subjects); this information was not included in the 1950 report written jointly by Los Alamos National Laboratory and University of Rochester. On the subject of patient selection and diagnosis, the draft report states: The individuals chosen as subjects for the experiment were a miscellaneous group of male and female hospital patients for the most part with well established diagnoses. Preference was given to those who might reasonably gain from continued residence in the hospital for a month or more. . . . Patients with malignant disease were also omitted from the group on the grounds that their metabolism might be affected in an unknown manner. . . . Of eleven patients in the Rochester group, ten were past the age of 45. One was only 18 years old but has since died of Cushing's Syndrome; a woman aged 49 years may have a greater life expectancy than originally anticipated due to an error in the provisional diagnosis. (p. 2) IV. DOCUMENTATION INDICATING PATIENTS AT UNIVERSITY OF ROCHESTER WERE NOT INFORMED AS TO THE NATURE OF THE PLUTONIUM AND URANIUM INJECTIONS Attachment 5, a December 9, 1971 report written by Dr. Patricia Durbin, Physiologist, Division of Biology and Medicine, records information she obtained regarding the plutonium injections during a visit to University of Rochester.6 [Patricia Durbin, December 9, 1971, ACHRE No. DOE-121294-D.] She writes the following about her discussion with Dr. Christine Waterhouse, who was a resident at the time of the plutonium injections: 4 She [Dr. Waterhouse] believes that follow-up of these persons is an important project and is willing to cooperate to the fullest. She still sees two of the people on a regular basis and has contacted the physician who has been caring for the third patient known to be still living. She believes that all three persons would be agreeable to providing excretion samples and perhaps blood samples, but they are all quite old--in their middle or late 70's and cannot travel far. More important, they do not know that they received any radioactive material. Attachment 6 is Dr. Durbin's December 10, 1971 report on a telephone discussion with Dr. Langham.7 [Patricia Durbin, December 10, 1971, ACHRE No. DOE-121294-D.] Dr. Durbin recorded: Classification (prolonged) and the passage of many years before even classified publication of the findings led to his [Dr. Langham's] eventual responsibility for analysis and publication of the results. He is, I believe, distressed by this and other aspects of the study itself--particularly the fact that the injected people in the HP series were unaware that they were the subjects of an experiment. Attachment 7, an October 24, 1946 intra-office District Engineer memo, was written to the Madison Square Area Engineer regarding a request from Dr. Andrew Dowdy, Director of University of Rochester's Manhattan Department, for clearance of Dr. Bassett's human uranium data for a departmental seminar.8 [R. S. Pearson to the Area Engineer, Madison Square Area, October 24, 1946, ACHRE No. DOE-121294-D.] The memo states the following regarding the classified nature of the information and the possibility that it might be leaked to the subjects and their families: As Dr. Dowdy states, all of the work on uranium experiments performed at the University of Rochester have been declassified. However, none of the work performed on humans has been declassified. Dr. Dowdy states that the patients were Dr. Bassett's, but it should be borne in mind that all the work performed by Dr. Bassett was performed at the request of the Manhattan District Medical Section. This seminar is to be conducted for persons who are all Doctors of Medicine and it is doubtful if this information would get out to any of the families of the patients or the patients on whom the experiments were performed. Other substances besides uranium which Dr. Bassett used are still on the classified list and this information will not be divulged at the seminar. 5 V. DOCUMENTATION REGARDING CLASSIFICATION OF THE PLUTONIUM STUDY Attachment 8 is a February 18, 1947 letter from Dr. Dowdy to Dr. Norris Bradbarry [sic], Director of Los Alamos Scientific Laboratory, in which Dr. Dowdy discusses the distribution and classification of the plutonium report:9 [Andrew Dowdy to Norris Bradbarry [sic], February 18, 1947, ACHRE No. DOE-121294-D.] There is one limitation which I should like to impose on the report which will emanate from the Los Alamos Laboratory and that is that it not be declassified for general distribution outside the Atomic Energy Commission without our foreknowledge. I make this suggestion because of possible unfavorable public relations and in an attempt to protect Dr. Bassett from any possible legal entanglements. Attachment 9 is an April 23, 1969 letter from Dr. Patricia Durbin to Dr. John R. Howard, Assistant Hospital Administrator, University of California Medical Center, regarding the University of California plutonium injections.10 [Patricia Durbin to John Howard, April 23, 1969, ACHRE No. DOE-121294-D.] Dr. Durbin writes the following regarding a possible explanation for prolonged classification of the plutonium report: Most of the patients injected with Pu were studied at other hospitals around the country, and although most were elderly and expected to have short life expectancies at the time of injection, some were misdiagnosed. Because of this, there was an understandably great uproar when the civilian A. E. C. took over from the Manhattan Engineer District. As a result, the human data thus obtained was classified 'Secret,' and so it remained for some years. VI. DOCUMENT ENTITLED "BRIEFING ON PLUTONIUM PROJECT BY DR. JAMES L. LIVERMAN ON APRIL 29, 1974"11 [James Liverman, "Briefing on Plutonium Project by Dr. James L. Liverman on April 29, 1974," ACHRE No. DOE-121294-D.] 6 Attachment 10 is an April 29, 1974 report given by Dr. Liverman on the early 1970's inquiry into the plutonium injections. He writes the following regarding the failure of Argonne Center for Human Radiobiology to bring their exhumation study promptly before the Argonne Human Use Committee: e. The study, although initiated in January 1973, was brought to the attention of the Argonne Human Use Committee in stages beginning in November 1973. The Committee met on March 14, 1974, and issued a report dated April 8, 1974, that recommended specific procedures that will bring the CHR in compliance with DHEW guidelines. f. In interviews, CHR Administration offered the following explanations for failure to present the plutonium studies to the Argonne Human Use Committee in February 1973: (1) Their opinion that the studies came under the scope of a protocol approved by that Committee in 1971. (2) The nature of the studies was to be suppressed to avoid embarrassing publicity for AEC. (p. 7) 7 List of Attachments Attachment 1 Advisory Committee Staff Document Summary entitled "Documentation of Manhattan District Biodistribution Program" Attachment 2 Langham, Wright. "Revised Plan on 'Product' Part of Rochester Experiment," copy, 21 p. ACHRE No. DOE-121294-D. Attachment 3 Letter dated March 13, 1946, from Dr. Wright Langham, Los Alamos National Laboratory, to Dr. Samuel Bassett, University of Rochester, re: "Your letter of February 27 regarding Hp 11 was startling, to say the least..." Copy; 2 p. ACHRE No. DOE-121294-D. Letter dated March 27, 1946, from Dr. Samuel Bassett to Dr. Wright Langham, re: I realize that there has been more trouble with specimens lately..." Copy; 2 p. ACHRE No. DOE-121294-D. Attachment 4 "Excretion of Plutonium Administered Intravenously to Man. Rate of Excretion in Urine and Feces with Two Observations of Distribution in Tissues," copy, 34 p. ACHRE No. DOE-121294-D. Attachment 5 Report by Dr. Patricia Durbin, Physiologist, Division of Biology and Medicine, dated December 9, 1971, re: "Dr. Christine Waterhouse was a resident during the years that the Pu people were injected and studied...." Copy; 1 p. ACHRE No. DOE-121294-D. Attachment 6 Report by Dr. Patricia Durbin dated December 10, 1971, re: "Dr. Wright Langham of the Los Alamos Scientific Laboratory, was the biochemist who performed the Pu analyses...." Copy; 1 p. ACHRE No. DOE-121294-D. Attachment 7 Memorandum from R.S. Pearson, Administrative Assistant, to the Area Engineer, Madison Square Area, dated October 24, 1946, re: "Uranium Studies in Humans." Copy; 2 p. ACHRE No. DOE-121294-D. Attachment 8 Letter dated February 18, 1947, from Andrew H. Dowdy, Director, University of Rochester's Manhattan Department, to Dr. Norris E. Bradberry [sic], Director, Los Alamos Scientific Laboratory, re: "Dr. Wright Langham and Dr. Samuel Bassett were discussing with me today the technical details relative to writing the report...." Copy; 1 p. ACHRE No. DOE-121294-D. 1