Attachment 1: Advisory Committee Staff Document Summary Entitled " Documentation of Manhattan District Biodistribution Program " (Tab I-1)

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Advisory Committee Staff Document Summary entitled " doc^ men tat i on of Manhattan D i strict 13i od i st r i but i on Program"

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Alamos) and Samuel Bassett (Rochester Metabolism Ward) regarding the eleven plutonium injection subjects at Rochester, and the sample analysis conducted by Langham at Los Alamos. The series includes a 3/13/46 letter from Dr. Langham to Dr. Bassett regarding the first terminal patient in the Hp series, Hp 11: "Your letter of February 27 regarding Hp 1 1 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." 2. 6/23/50 - 12/1/50 series of Langham, Bassett, and Howland correspondence regarding patient followup, including an 10/2/50 letter from Dr. Langham to Dr. Joe Howland, Chief of University of Rochester's Division of Medical Services: "I am very glad to hear that you will manage to get follow-ups on the two subjects. The x-rays seem to be the all-important thing, but please get them in a completely routine manner. Do not make the examination look unusual in 3. 7/7/44 letter from Friedell to Mulliken (Project Information Department) re responsibility of Dr. Stone for the distribution of Rochester health and protection reports: "Discretion as to whom these reports should be forwarded would be retained by the health director of the Metallurgical Laboratory." 4. 8/4/44 memo from Stone to Mulliken re limited distribution of Rochester reports: ". . .the Rochester reports are much more limited in their circulation than the Chicago reports and we will not be permitted to pass out the information to anythmg like the group that are apparently now 5 . 8/29/44 memo from Hempelmann to Oppenheimer summarizing biological research program decided upon in a meeting between Stafford Warren, Oppenheimer, Hempelmann, and Kennedy, including tracer experiments in humans to determine plutonium excretion rate: "When satisfactory analytical methods have been developed in the laboratory the problem of carrying out fbrther metabolic studies will be turned over to another medical group, presumably the Rochester group." 6. 12/1/44 letter from Stafford Warren to Dowdy re obtaining metabolic data on thorium: "It is the opinion of this section that a limited number of carefbl human experiments should be made with this material." I All documents are listed in chronological order except for the first two series of wrrespondence between Los Alamos and University of Rochester, which span a five-year period.

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7. 12/1/44 letter from Ferry (Captain, Medical Corps)to Voegtlin (toxicologist at Rochester) re thorium data, requesting the submission of "a memo to this office recommending a change in the tolerance levels. . . .Since a relaxation in the tolerance levels would facilitate plant operations, it is recommended that this data be accumulated with the least possible delay." 8. 3/13/45 letter from Bale to Friedell re polonium tolerance calculations which "may be useful to you in arriving at a possible tolerance or permissible dose figures for postwn in plant 9. 4/11/45 letter from Friedell to Hempdmann re "protocol ofthe clinical experhent. . . .I think that we will have access to considerable clinical material here, and we hope to do a number 10. 4/17/45 memo from Stafford Warren to Nichols re Purpose and Limitations of the Biological and Health Physi& Research Program: "For consideration of the medical and legal aspects, including neceSSBcy biological research, it should be pointed out, however, that investigations should be conducted only insofbr as they will augment that data and idormation available fiom operating personnel and from the operating tircilities and should be limited to those features which are deemed most likely to embarrass the government." ' 1 1. 5/21/45 letter from Langham to Friedell re future of plutonium injection project, ' further human studies, and the establishment of a working tolerance for plutonium of one 12. 5/31/45 documentation of Warren's trip to clear Dr. McCann at Rochester for handling and knowledge of classified materials in connection with human volunteer experiments. 13. 6/2/45 memo from Friedell to District Engineer, New Mexico re future experiments with plutonium (response to Langham's 5/21/45 letter) and two future injections into 14. 6/5/45 memo from Dowdy to Bale re expanded metabolism program at Rochester, initiated by Stafford Warren, increasing number of subjects for studies using plutonium, polonium, Cpd 22 (probably uranium), thorium, lead, and radium. 15. 7/26/45 memo re determination of policy on cases of exposure to occupational disease, which discusses an employee with nephritis, probably due to occupational exposure to thorium and other materials, who was "unaware of her condition which now shows up on routine physical 16. 8/17/45 response from Stone to Warren's 4/17/45 memo, stating his opinion that research should not be done "to 'strengthen the government interests' from the medico-legal point of view. Research should be done to establish the facts. . . .If the health and welfare of the workers are the

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main objects, the medico-legal aspect is automatically taken care of" 17. "Detailed Plan of Product Part of Rochester Experiment," Hempelmann and Langham, providing for ten subjects from the Rochester area for the plutonium studies, and fifty (five groups of ten) for the overall long-lived radioisotope metabolism program. 18. "Revised Plan of *Product*Part of Rochester Experiment," Langham, based on a September meeting with Rochester staffand Captain Bryan representing Colonel Warren's ofiice. On selection of subjects: "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 chroNc arthritics or carcinoma patients without primary involvement of bone, liver, blood or kidneys. It is of primary importance that the subjects have relatively n o d 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." 19. **Contributionsof the Division of Special Problems to the Manhattan Project," Bale, including polonium metabolism in human subjects and human tracer studies with plutonium and radium. 20. 1016145 "Tolerance and Permissible Concentration of Polonium in the Water and Air," Morgan, citing Bale and Fink's polonium work at Rochester. 2 1. 10/24/45, table of contents of **AStudy of the Excretion and Distribution of Plutonium in a Human Subject," Nickson and Russell (Argonne), including "Possible value in using a 22. 12/5/45 letter from Fink to Friedell, forwarding summary of Rochester work with polonium: "We trust it may be of use in .connection with the forthcoming conference on 23. 5/13/46 record of plutonium ingestion experiment using six subjects. Unknown source 24. 5/31/46 report **AComparison of the Metabolism of Plutonium (Pu 238) in Man and the Rat," Scott, Hamilton, et al., describing injection and tissue collection from one human subject, and comparison to rat data. 25. 9/13/46 letter from Dowdy to District Engineer, Oak Ridge re possible declassification of certain compounds: "We should like to raise again the question of declassifltng our polonium studies inasmuch as the original decision on the subject may have been due to a misapprehension as to the nature of the work. . . .The work has been carried out with less than two millicuries of polonium, an amount obtainable with relative ease during the war, and accordingly it would

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appear that the requirements of the Responsible Reviewer's Declassification Guide could be met in 26.. 9/24/46 letter from Kdler (Deputy Declassification Omcer) to Dowdy, recommending that the polonium studies be submitted to Friedell for declassification. 27. 10/22/46 letter from Dowdy to the Area Engineer, Rochester re clearance for Bassett to discuss Rochester uranium studies at a departmental seminar: "He will not mention any other substances which he has similarly used on humans and which have not as yet been cleared." 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 "At the time these experiments were started, this office was given strict orders that the information should not be released to any but authorized persons. Almost all the correspondence and result of experiments were exchanged between Dr. Wright Langham at Santa Fe and Dr. Bassett of the University ofRochester. This rule is still in effect on some of the material that Dr. Bassett is using and knowledge of the experiments is kept fiom personnel at the Rochester Area." 29. 12/24/46 memo from Brundage to Cooney (MEDMedical Director) re progress report from the Berkeley area: ". . .I am attachhg a letter for the signature of Colonel Nichols advising that work described in this paragraph cannot be made a part of the Manhattan Enginem District program. This letter is intended to be directed to the Area Engineer of the Berkeley Area. "The work in question in the progress report is the intravenous administration of certain Manhattan District products to human subjects." 30. 12/24/46 letter (attached to 12/24 memo) from Nichols re Berkdey work: "After discussion with Colonel James P.Cooney, Medical Director, Manhattan Project, it is felt that such work does not come under the scope of the Manhattan District Program and should not be made a part of its research plan. human subjects but also to deny authority for such work under the terms ofthe Manhattan contract. You will take immediate action to stop this work under this contract, and report to this "It is therefore deemed advisable by this office not only to recommend against work on 3 1. 2/13/47 memo from Armstrong to Marsden re Report of the 23-24 January 1947 of the Interim Medical Committee, abstracting parts of the recommended programs for 1947-48 which involve use of human subjects at University ofRochester, University of California, and Los Alamos, and citing them as "applicable to the present discussion of medical research policies."

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32. 2/18/47 letter from Dowdy to Friedell re inclusion of the data from the Oak Ridge plutonium subject in the plutonium report. *33. 2/18/47 letter from Dowdy to Bradbury (Los Alamos) re the distribution of the plutonium report (which would remain classified): "There is one limitation which I should like to impose on the report which will emanate fiom 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 fiom any possible legal entanglements." 34. 3/7/47 memo from Burling (AEC hgd Division) to Huddleson (Deputy General Counsel) r e clinical testing (preceding Wilson letter to Warren re consent and therapeutic purpose), recording a conference between Huddleson, Burling, Warren, and Brundage: "The Legal Division. . .expressed the view that it was most important that it be susceptible of proof that any individual patient, prior to treatment, was in an understanding state of mind and that the nature of the treatment and possible risk involved be explained very clearly and that the patient express his willingness to receive the treatment. On Dr.Warren's recommendation, you authorized omission to obtain written release but urged that in every case at least two doctors certifL in writing to the patient's state of mind to the explanation firnished him and to his acceptance of the treatment." 35. University of Rochester "Proposed Research Program and Budget, July 1,1947 - July 1, 1948, including human tracer studies using polonium, plutonium, uranium, thorium, radiolead, 36. 3/19/47 memo from Brundage to Armstrong, approving the Rochester "Proposed Research Program and Budget," and pointing out parts implying possible human work. 37. 4/30/47 letter from Wilson to Warren reiterating the policy on consent recorded in the 3/7/47 Legal Division memo, and M e r stating that "treatment (which may involve clinical testing) will be administered to a patient only when there is expectation that it may have 38. 5/7/47 letter from Lilienthal to Gregg proposing a Medical Board of Review to evaluate the report and recommendations of the Manhattan District Medical Advisory Committee. 39. 6/20/47 report of the Medical Board of Review: "The need for medical and biological research on the various effects of radioactive substances and atomic fission is both urgent and carried out within Atomic Energy Commission installations. It will also be desirable to encourage and, where necessary, support with finds correlative studies at universities, contributing to knowledge on the biological and medical effects of radiation but not involving the ' I . . .Those activities involving classified materials or operations must be supported by and

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40. 10/14/47 letter from Lilienthal to Bereton (Chairman, Military Liaison Committee) and attached Oak Ridge staff study on the feasibility of radiological warfare (Aebersold, Morgan et d.) analyzing polonium's biological ef€ectiveness as a potential radiological warfare agent (using human kidney tolerance of polonium). 4 1. 12/2/47 memo from Bwsett to Bale re proposal of work for Metabolism Section: "In the autumn of 1945 the Section on Human Metabolism was activated under your direction at the request of the Manhattan Engineer District to carry out certain tracer studies with long-lived isotopes. As you know,this program was disconGnued in the spring of 1947 under a directive from the Atomic Energy Commission although we were instructed to keep the personnel of the section intact." Bassett goes on to propose a new program for the section involving investigation of radiation injury treatments. 42. 12/3/47 memo from Bale to Dowdy re 12/2 memo from Bwsett: "The general work outlined has my approval, and I suggest that it be accepted as the project research program of the Metabolism Section until our position with regard to tracer studies with heavy elements is 43. 1/6/48 memo from Blair to Bale re Human Metabolism Program:"By phone on January 2nd, Dr.Wolf stated that he had d v e d a decision fiom Dr.Shields Warren that the human metabolism work under Dr.Bassett was to be discontinued. to be kept on file." Consequently, unless some new program is presented, it will no longer be necessary to Dr. Wolf would also like Dr. Bassett to Write a complete history ofthe work done to date 44. 2/29/48 **TheExperimental Use of Radioactive Materials in Human Subjects at AEC Establishments" (handwritten date), Committee on Isotope Distribution (at the request of Dr. Shields Warren) re use of radioactive materials in normal human subjects and patients, consent, necessity of preliminary animal studies, and radiation dose …