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 xxx DRAFT x FOR DISCUSSION PURPOSES ONLY xxx MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: December 8, 1994 RE: Background Materials on Mid-Century VA Radiation Research Activities This memorandum describes several attached documents that help to provide an overview of the mid-century radiation research activities of the Veterans Administration (VA). The story begins with the establishment of a Central Advisory Committee on Radioisotopes, and includes information from annual events/reports, as well as details about specific experiments at individual VA sites. As additional background, you may wish to refer to a staff memorandum in the June Briefing Book, which described the 1947 creation of VA's "confidential" Atomic Medicine Division, the first radioisotope units, and the early review process. Please note that an additional key document, a May 13, 1959 memorandum from VA's Chief Medical Director to the Administrator recommending Dr. George Lyon for an Exceptional Service Award, which provides additional information about VA's "confidential' Atomic Medicine Division, is discussed in a separate staff memorandum in this Briefing Book, also in this Tab. Additional historical materials of interest will be furnished to you as they become available. Attachment 1 : AN AUGUST 15, 1947 LETTER FROM ACTING CHIEF MEDICAL DIRECTOR E.H. CUSHING TO STAFFORD L. WARREN REQUESTING THAT HE JOIN VA'S CENTRAL ADVISORY COMMITTEE ON RADIOISOTOPES The letter sets forth the goals and responsibilities of the Committee, as well as those of VA's radioisotope program. Identical letters were also sent to each of the other four prospective members (Hymer Friedell, Perrin Long, Hugh Morgan and Shields Warren). 1 ATTACHMENT 2: SEPTEMBER 15, 1948 SUMMARY AND SPECIFIC RECOMMENDATIONS AND MINUTES OF CENTRAL ADVISORY COMMITTEE ON RADIOISOTOPES This document summarizes policy recommendations for the expansion and administration of VA's radioisotope program. ATTACHMENT 3: A JULY 29, 1949 LETTER FROM A. GRAHAM MOSELEY TO STAFFORD WARREN WITH PROCEEDINGS OF A MARCH 17-18, 1949 MEETING OF REPRESENTATIVES OF RADIOISOTOPE UNITS The minutes amply illustrate of one of the key reasons why these meetings were held: mutual education. Much of the second day entailed discussion of activities at various field sites; these included the use of radiophosphorus to treat leukemia and polycythemia and the use of radioiodine for diagnosis and treatment of thyroid disease. The minutes also offer some insight into the ethics standards of the time. For example, there is a notation that the group had "a general discussion of the philosophy of the use of toxic agents in medical research on human subjects. . . . It was agreed that the ordinary standards of consideration and caution as used by medical research workers generally was the best protection the human subjects could have." (page 1) A presentation on legal liability connected with radioisotope use included a discussion of a physician's potential liability to a research subject for assault and battery; it was noted that a "suit could be brought regardless of whether or not the subject had signed a prior consent enabling the physician to make such a study." (page 5)1 [The history of VA's ethics policies and practices is discussed in greater detail in a separate binder on the History of Agency Ethics Policies and Practices.] Interestingly, VA researchers' discussion of patient consent as an outgrowth of legal liability seems to parallel discussions at the highest levels of other agencies at the time they first considered the issue of consent. ATTACHMENT 4: ABSTRACTS OF PROGRESS REPORTS OF FIELD RADIOISOTOPE UNITS (ATTACHED TO SEPTEMBER 15, 1949 MINUTES OF THE THIRD ANNUAL MEETING OF THE CENTRAL ADVISORY COMMITTEE ON RADIOISOTOPES) The abstracts include synopses of research ranging from blood volume studies with Phosphorous-32 at Framingham, MA, Bronx, NY and other sites to an Iron-59 study at San Francisco, CA. 2 ATTACHMENT 5: 1952 ARTICLE ON "THE ROLE OF THE NURSE IN THE RADIOISOTOPE PROGRAM" This article, written by Mrs. Jane Perini, a nurse at the Wadsworth VA Hospital (West Los Angeles), offers a unique perspective on VA's use of radioisotopes. She notes (at page 17) that "[f]or its own protection the administration of the hospital requires a form called Authorization for Radioactive Isotope Procedure to be signed by the patient for both tracer dose and therapeutic dose." ATTACHMENT 6: AUGUST 12, 1954 NATIONAL ACADEMY OF SCIENCES/ NATIONAL RESEARCH COUNCIL'S BIO SCIENCES INFORMATION EXCHANGE FORMS These forms indicate that Dr. Joseph Ross and biologist James Halkett of the Boston VA Hospital conducted several studies on VA patients to examine iron absorption after ingesting food (i.e., eggs, chicken, rabbit and vegetables) laced with radioactive iron. ATTACHMENT 7: A JANUARY 31, 1956 LETTER FROM FRANZ K. BAUER TO STAFFORD WARREN ENCLOSING THE ANNUAL PROGRESS REPORT OF THE WADSWORTH (WEST LOS ANGELES) VA HOSPITAL RADIOISOTOPE SERVICE The progress report illustrates the close connection between the Wadsworth VA Hospital and UCLA, and discusses the use of radionuclides for diagnosis, therapy and research. A list of publications and presentations is attached. 3