2 15 24 https://www.nal.usda.gov/exhibits/speccoll/files/original/a0107319411c24ad329c9d98088573fa.pdf 820d6cf7d3fcdfe7926cdec1149874c5 PDF Text Text Item ID Number °1695 Author LeVois, Maurice E. Corporate Author Roport/Artldo Title Memorandum: Agent Orange Research Predecisional Memorandum, from Maurice E. LeVois to Administrator, July 29, 1982 Journal/Book TltlB Year 000 ° Month/Day Color r] Number of unages 2 Descriptor Notes Monday, June 11,2001 Page 1696 of 1793 �Veterans Administration Director, Agent Orange Research and Education Office (001E) July 29, 1982 Administrator Slll : " Agent Orange Research Prcdec is iona 1 Memorandum ].. The Ayent Orange epidemiology research protocol has been reviewed and approved, in general terms, by the White House Agent Orange Working Group (AOWG) Science Panel, the Congressional Office of Technology Assessment (OTA), and the VA Advisory Committee on HeaJth~Related Effects of Herbicides. Although some differences remain among the recommendations made by these committees, all three of these review groups support tte idea of including a third cohort to evaluate the effect of the "Vietnam experience" on the health of veterans. vi 2. The AOWG strongly endorses the three cohort research design as an effective means of evaluating the health effects of both the Vietnam experience and of exposure to Agent Orange. 3. The three cohort research design may have far reaching implications: a) A third cohort will increase the cost of the study by nearly 50%; b) A throe cohort study design will increase the total number of hypotheses to be tested and, therefore, will increase the probability of finding both real and chance effects; c) Specific risk factors or exposures will be impossible to identify in the "Vietnam experience" portion of the study. Flealtii problems found to be associated with Vietnam service niay require further research to identify causation and establish the relative increase in risk for each health problem; d) For the purpose of compensation, the assumption of exposure to a general health risk factor by anyone who served in Vietnam, without requiring documentation of a specific exposure, may include very large numbers of veterans. This also applies to the process of compensation based upon Agent. Orange results; *•) If common health problems are found to te weakly associated with Agent Orange or service in Vietnam (i.e. only a slight increase in relative risk) then the VA may want to consider an "attributed risk" formulation for compensating veterans. 4. It is your decision whether or not the VA will conduct a study of three or only of two cohorts, Public Taw 97-72 states that you "may" broaden the scop} of the study to look at the general health effects of service in Vietnam, You rrwy also limit the focus of the study to the Agent Orange issue. �'there are a nurnter o£ options available to you: a) Broaden the .scop:; of the study by including a third cohort as the AQWG recommends. This option appears to be consistent with the wishes of the veterans" service organizations and the Congress; b) Limit the scope of the study to the health effects of Agent Orange exposure and study only two cohorts. The U.C.L.A. authors of the research protocol recommend this option on scientific grounds, but do not present: a strong argument for their position; c) Proceed with plans for a pilot study contract based upon three cohorts. If the National Academy of Sciences (NAS) ^review group recommends against the three cohort design drop the third group and re-negotiate the pilot study contract; d) Proceed as in c) atovc. If NAS agrees that a three cohort study is appropriate, then the pilot study can be used to evaluate the feasibility of the three cohort design. Participation rates may be lowest for the third, non-Vietnam, cohort. If. fewer titan 70% of the potential subjects in that group participate in the pilot study, the third group may have to be dropped from the final design for statistical reasons; e) Ask the VA Advisory Committee on Health-Related Effects of Herbicides and the VA Policy Coordinating Committee (PCC) to consider the three cohort design issue and provide you with their independent recommendations. MAURICE E. r.EVOlS Director, Agent Orange Research and Education Office � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 063 Folder The folder containing the original item. 1695 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource LeVois, Maurice E. Title A name given to the resource Memorandum: Agent Orange Research Predecisional Memorandum, from Maurice E. LeVois to Administrator, July 29, 1982 Subject The topic of the resource Agent Orange Exposure Study AOWG study criticism study protocol ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/db66bc9a47f71dfe987d292c6ebd0809.pdf c8096af243b6f4c551649b5f1b6005ae PDF Text Text °1703 Item ID Number Author Corporate Author Report/Article Title Typescript: White Paper: Status of VA Epidemiologic Study of Agent Orange, August 27, 1982 Journal/Book Title Year 000 ° Month/Day Color n Number of Imagoe 2 DeSCMptOn NOtOS "DM&S" typed next to date. Monday, June 11, 2001 Page 1704 of 1793 �DM&S 8/27/82 WHITE PAPER STATUS OF VA EPIDEMIODOGIC STUDY OF AGENT ORANGE The epidemiology protocol originally submitted to the VA by the U.C.L.A. School of Public Health on April 29, 1982, has now been reviewed by the VA Advisory Committee on Health-Related Effects of Herbicides, the White House established Agent Orange Working Group (AOWG) and the Office of Technology Assessment. All of these review groups have noted that further development of the research protocol is needed in certain areas. For example, each of the following topics has been mentioned by one or more of the protocol review groups as needing additional attention: a clear statement of specific hypotheses to be tested; the data reduction and analytic methods to be employed; the rationale for a third cohort; and more exact statistical power calculations associated with these refinements of the protocol. The protocol is currently being reviewed by a committee of the National Academy of Sciences (MAS). The VA has been advised that MAS is now in the final stages of this review process. It is expected that the report will be completed and forwarded to the Veterans Administration by the third week of September. Further refinement of the protocol is underway and should be completed during the month of October. Barring unforeseen complications, a contract for the conduct of a pilot study of approximately 900 veterans (or 300 per cohort) should be awarded in the January-February 1983 time frame. A critical component of the pilot study will be to evaluate the cohort selection procedures and the feasibility of developing cohorts for the full scale study which will be twenty times larger than the pilot study cohorts. This aspect of the protocol was not developed by U.C.L.A. and has become the focal point of recent activity by the VA, the Army Agent Orange Task Force (AAOTF) and the AOWG. The basic issue is whether the military records are sufficiently complete and detailed so as to provide a reliable indicator of �"likelihood of exposure" to herbicides. The present assessment of the records suggest that identifying the cohort with a high likelihood of exposure will be easier than identifying the cohort with low likelihood of exposure. The reason for this is that the present records of herbicide missions, the HERBS Tape, provide a reference point for estimating likelihood of exposure because tracking a company in an area known to have been sprayed with herbicides on a given day can be objectively determined by the records. When looking for units considered "not likely exposed" the record searchers can only assume selected units were not near herbicide targets; a subjective evaluation; thus, they cannot document the absence of exposure to herbicides. It is important therefore to note that misclassifying an individual as to likelihood of exposure can result in "diluting-out" any health effect that may be present and associated with exposure. The AOWG has appointed a subcommittee of its Science Panel to establish procedures for cohort selection for the epidemiology pilot study. The VA has brought in biostatistical consultants to work with this subcommittee and with the AAOTF. The subcommittee is now in the process of preparing its final report to the Science Panel. When this report is forwarded to the VA, a recommendation will be made by the Chief Medical Director to the Administrator as to whether the pilot study will focus only on Agent Orange or whether it will center on the total Vietnam experience with Agent Orange as a major emphasis. The pilot study itself is expected to be a major factor in the final decision to broaden or limit the scope of the full scale epidemiology study. That decision may not be made until the results of the pilot study are available in late 1984 or early 1985. 2. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 063 Folder The folder containing the original item. 1703 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Typescript: White Paper: Status of VA Epidemiologic Study of Agent Orange, August 27, 1982 Subject The topic of the resource Agent Orange Exposure Study AOWG AAOTF study protocol ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/4f904ee6bde921600602aec66129b9c8.pdf 2d917d2fec3f208acdd6536c4758daf5 PDF Text Text Item ID Number 01708 Author LeVois, Maurice E. Corporate Author RBPOrt/ArtlClB TltlO Typescript: [Update on study protocol], September 20, 1982 Journal/Book Title Year 000 ° Month/Day Color a Number of Images 3 Descriptor Notes Monday, June 11, 2001 Page 1709 of 1793 �1. On 5 March 1982, the AOWG Science Panel approved a 4 December 1981 DOD/AAQTF conceg<t. _jaaper on cohort selection. Scecifically, what the Science Panel approved was the genera1 jprinicj, ple of selecting battalion, and then company size, military units for exposrue analysis, assigning the company A/O exposure score to each member of that company. If an individual was reported absent on a day when his company received an exposure, that individual's exposure score would be reduced accordingly. This is a departure from the approach suggested by UCLA, in which individual subjects were to be drawn at random and exposure scores developed for each subject individually. 2. On 5 March 1982, the Science Panel states: "The Science Panel will oversee this cohort selection process." The 4 December 1981 DOD/AAOTF concept gaper was clearly not a scientifically rigorous methodological protocol. AOWG approval of that document should not have been construed as a signal to proceed with the actual selection of subjects without first developing a step-by-step protocol with the assistance of the Science Panel and othe qualified scientists. 3. On 10 June 1982, the VA submitted to the AOWG Science ' Panel a memorandum (attached) concerning AAOTF cohort selection activities. That memo alerted members of the �Science Panel to the fact that inappropriate and unapproved decisions concerning cohort composition, exposure criteria, and selection methods had been made independently by DOD/AAOTF. It was the VA's belief that, if the AAOTF proceeded to select subjects as they proposed, their efforts would produce unusable cohorts and no useful data on the feasibility of conducting the larger study. 4. Between 4 December 1981 and 10 June 1982, meetings were held on the topics of Agent Orange exposure and cohort selelction and some important progress occured. °It was generally agreed that a third cohort, roughly comparable to the two Vietnam cohorts could be assembled, if that were called for by the final study design. °A general AAOTP cohort data automation contract was developed by AAOTF. It should be noted that general functional capabilities, not specific data elements, were approved by the VA. °A Ranch Hand mission time/distance exposure matrix was developed. "Methods of equating the different modes of exposure were proposed. Work on this problem continues. "The AAOTF proceeded with work on an augmented "services" herbicide application record. This work also continues. The AAOTF was never asked by the AOWG or the VA to halt work on the documentation of herbicide use in Vietnam. This informiWon is essential to any cohort selelction process. �°On 8 April 1982, a letter was sent from VA Administrator Nimmo to Secretary Weinberger addressing the need for the support and cooperation of both agencies in this research effort, (attached) *J °0n 8 April 1982, a memo was sent by Secretary Scheiker to A Secretary Weinberger, (attached) That memo recommended that DOD assume responsibility for cohort selection in support of the VA study. "On 26 April 1982, Secretary Weinberger issued a tasking memo to the Secretaries of Army, Navy and Air Force authorizing full DOD support of this effort, (attached) "The AOWG Science Panel created a subcommittee to 1. develop an acceptable Agent Orange exposure index 2. develop a cohort selection protocol for the AAOTF. °On 8 September 1982, the Chairman of the Science Panel forwarded to DOD a draft protocol for cohort selection for DOD approval. 5. The AOWG and the VA can not provide the kind of continuous scientific supervision which is required for proper cohort selection. It has become clear that this important, complex and costly effort cannot be adequately supervised by a physiologist. The AAOTF should obtain the assistance of a qualified epidemiologist and/or biostatistician before proceeding with their cohort selection pilot work. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 063 Folder The folder containing the original item. 1708 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource LeVois, Maurice E. Title A name given to the resource Typescript: [Update on study protocol], September 20, 1982 Subject The topic of the resource Agent Orange Exposure Study AAOTF study criticism AOWG ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 079 Folder The folder containing the original item. 2030 Series The series number of the original item. Series III Subseries IV Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Donovan, John W. Title A name given to the resource Letter: to Barclay Shepard from John W. Donovan, 27 June 1984 Subject The topic of the resource AOWG international cooperation ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/72b052afa308d2ef9586e3adc75a955f.pdf 63be1bd4bb5e2574fb4ae68f2848d9f1 PDF Text Text Item D Number °2034 Author Young, Alvin L. Corporate Author RBDOrt/ArtiCle Title Letter: to The Honorable Mr. Justice Phillip Evatt from Alvin L. Young, July 13, 1984 Journal/Book Title Year 000 ° Month/Day Color D Number of Images 1 DeSCrlptOn NOtBS Letter is updating Evatt on the Agent Orange activities in the United States, including several studies. Young also expresses his opinion that the Royal Commission must continue its work seeking a thorough assessment of the scientific data so that the most accurate picture and answers can be given to the veterans of both countries. Tuesday, August 07, 2001 Page 2034 of 2084 �EXECUTIVE C OFFICE OF SCIE ,/ - -- OtOGY POLICY WASH^UTON, D.C. 20506 July 13, 1984 Dear Judge: It has been a few months since our last communication. I believe it is important to bring you up-to-date on activities related to Agent Orange. Currently, efforts are underway through the auspices of the White House Agent Orange Working Group, to advance the Veterans Administrations Identical Twins Study (VETS) and the National Institute for Occupational Safety and Health's (NIOSH) Dioxin Registry and accompanying mortality and morbidity studies. In addition in mid-August the Center For Disease Control will release its completed Birth Defects Study. Although, much of the activity involving the Vietnam Veterans and Agent Orange appears, at least in the press, to center on the legal out-of-court settlement activities in New York, the Federal Government continues to press for scientific answers to the critical health questions posed by this issue. The dichotomy is that in the United States we may not get the opportunity to place before the public and the veteran and scientific communities a proper assessment of the scientific information. For that reason, I believe it is imperative that the Royal Commission continues to seek a very thorough assessment of the scientific data. It is only through a process of open and complete scientific dialogue that we can hope to provide answers to the very complicated situation that surrounds the men and women who so gallantly served in Vietnam. I hope that the proposed epidemiologic study, planned during my visit to Australia, can be conducted and the results viewed by your Commission. I feel that a trip to the United States to meet with the research and veteran communities should clearly be taken before the Commission completes its assessment. I will be pleased to assist in appropriate arrangements. Sincer Alvin L.l YoCTng, Ph.D. Senior Policy Analyst for Life Sciences The Honorable Mr. Justice Phillip Evatt, D.S.C. Royal Commissioner Royal Commission on the Use & Effects of Chemical Agents on Australian Personnel in Vietnam G.P.O. Box 4842 SYDNEY, N.S.W., 2001 , AUSTRALIA � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 079 Folder The folder containing the original item. 2034 Series The series number of the original item. Series III Subseries IV Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Young, Alvin L. Title A name given to the resource Letter: to The Honorable Mr. Justice Phillip Evatt from Alvin L. Young, July 13, 1984 Subject The topic of the resource AOWG Vietnam Experience Twin Study NIOSH international cooperation ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 079 Folder The folder containing the original item. 2038 Series The series number of the original item. Series III Subseries IV Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Donovan, John W. Title A name given to the resource Letter: to J. D. Erickson from John W. Donovan, June 27, 1984. Subject The topic of the resource AOWG Australian Royal Commission hearings CDC Birth Defects Study international cooperation ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 064 Folder The folder containing the original item. 1730 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Keller, Carl Title A name given to the resource Memorandum (Draft): Possible Study of Female Vietnam Veterans, from Carl Keller to Edward N. Brandt, August 6, 1984 Subject The topic of the resource veteran health and hygiene study protocol AOWG ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 080 Folder The folder containing the original item. 2075 Series The series number of the original item. Series III Subseries IV Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Date A point or period of time associated with an event in the lifecycle of the resource June 25 1986 Title A name given to the resource Letter: from W.F. Ginnivan to Dr. Al Young, 25 June 1986 regarding Veterans' Affairs memorandum about CDC study Subject The topic of the resource Australia CDC Birth Defects Study AOWG ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/6c990d636a544a4e4f4160da0d919994.pdf 6f3ba42969deef3d06f65df2958cf48b PDF Text Text Item ID Number °1835 Author Keller, Carl Corporate Author Report/Article Title Memorandum with several attachments: from Chairman, Science Panel, AOWG, to Members of the Science Panel, AOWG, with subject Meeting of the Science Panel, dated February 5, 1985. Journal/Book Tito Year 000 ° Month/Day Color H Number of Images 12 DOSCTipton Notes Avn ' ' L- Young filed this item under "Vietnam Veterans Twin Study." Memo gives notice of a science panel meeting scheduled for February 21, 1985 with the purpose of reviewing the VETS II protocol. Attachments include inquiries about the possiblity of a female Vietnam veterans study, and the minutes of the November 29,1984 meeting of the Science Panel of the Agent Orange Working Group. Wednesday, July 11, 2001 Page 1836 of 1870 �"r DEPARTMENT OF HEALTH & HUMAN SERVICES • Date Memorandum February 5, 1985 From Public Health Service National Institutes of Health Chairman, Science Panel, AOWG Subject Meeting of the Science Panel TO Members of the Science Panel, AOWG This is to announce that there will be a meeting of the Science Panel of the Agent Orange Working Group at 9:30 a.m., February 21, 1985, in room 729G of the Hubert Humphrey Building, Washington, D.C. The purpose of the meeting will be to review the protocol for the Veterans Administration Twin Study (VETS II). You will (or will have) receive(d) a copy of this protocol under seperate cover. I am enclosing some comments made by a special review group last summer for your information. Please bring your written comments to the meeting and we will summarize our review at that time. We have also received additional congressional correspondence concerning female Veterans' needs. It appears that we are now being requested to recommend what, if any, studies of the health of female Vietnam veterans should be done and to examine proposed studies in that light. I am enclosing appropriate materials and we will discuss this at our meeting. In addition, please find enclosed the minutes of our last meeting (November 29, 1984) for your approval. Carl Keller, Ph.D. �OW1AUN X. MmOM. WVOMWO. ITKOM TMumwND. SOUTH CAMX.INA ALAM CRANSTON. CAuraMM ftOeCRT T. STAf FOMO. VERMONT JCNNINCS lUNOOLPH. WIST VMOMIA MANX H. MUMOWMI. ALASKA (MM M. MATSUNAOA. HAWAII AMCN WCrtll. KNNtnVANM MNNW MCONCIM. AMMNA JCMMIAM OCNTON. ALAIAMA MOMI J. MffCHIU. MANN KUOYSOSCHWraMMNUOTA ANTHONY J. HHNCm CHW COUNSH/tTAW OMICTM JONATHAN H STIIMfMO. MIMOMTY CNItf COUNSO/ STAW OMCTOII A\\ ^.t.^_ * ClLj flff * ff JfeVUllVU • t^+-^*~.^. Pftfafpa 0WVf»VlAJ *^ * ~MtPllfif? 0WIUIV%> COMMITTEE ON VETERANS' AFFAIRS WASHINGTON, DC 20510 January 23, 1985 Honorable Charles Baker Chair Cabinet Council Agent Orange Working Group Department of Health and Human Services Humbert Humphrey Building, 614-G 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Mr. Baker, I have long had a strong interest in the issue of how the Federal Government might conduct research to investigate the possible health effects in female Vietnam veterans of their exposure to Agent Orange. Enclosed is a copy of an October 16, 1984, letter to me on this subject from Dr. James 0. Mason, the Director of the Centers for Disease Control. It is my understanding that the draft protocol outline mentioned in Dr. Mason's letter is pending in the Agent Orange Working Group and may be considered during the Group's next meeting, which is scheduled to take place in early February. I believe that it is extremely important that research be undertaken on this issue, and I strongly urge that the Working Group undertake its review of the protocol outline as expeditiously as possible. It is my strong hope that the members of the Working Group will be able to report favorably on the possibility of a study of female Vietnam veterans, either by endorsing the protocol outline as developed by CDC or by suggesting whatever changes to the outline the members believe are needed in order for a study to go forward. Thank you for your attention to my views on this issue. I would appreciate hearing from you on this matter as soon as possible after the Working Group's February meeting. With best wishes, Sin Alah Cranston Ranking Minority Member Enclosure �CTER JUDICIARY APPROPRIATIONS VETERANS' AFFAIRS WASHINGTON. D.C. 20SIO January 4, 1985 The Honorable Margaret M. Heckler Secretary Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Heckler: I write regarding the government's epidemiological study on Agent Orange being conducted by the Centers for Disease Control (CDC). As a member of the Senate Veterans' Affairs Committee, I am very concerned that CDC's study fails to include women who served in Vietnam. Approximately 20,000 women served there as members of the military or as civilians employed by service organizations. Many of these women are now suffering from health problems that may be associated with Agent Orange. It is my sense that research is needed to assess the problems among women who were in Vietnam to avoid excluding them from Agent Orange compensation programs. I urge that this omission be rectified by the Health and Human Services Administration. Your consideration of this request is greatly appreciated. Sincerely, Arlen Specter AS:gfs _ *s •- TRACER �'DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Memorandum Date 'December 20, 1984 From Director, Center for Environmental Health Subject Possible Study of Female Vietnam Veterans To Dr. Carl Keller Chair, AOWG Science Panel At the Agent Orange Working Group (AOWG) Meeting of December 4, 1984, Dr. Brandt requested that the Centers for Disease Control (CDC) and the AOWG Science Panel discuss what additional information the Science Panel would need to assess the scientific utility of a study of female Vietnam veterans. As you know, CDC assessed the feasibility of a study of women veterans and described the possible study approach in a protocol outline dated June 25, 1984, copy attached. In that document and in the attached memorandum to Dr. Brandt from Dr. James Mason, CDC Director, responding to the Science Panel's initial critique, of the protocol outline, CDC stated its belief that a comprehensive health assessment of female Vietnam veterans motivates the study, rather than any specific hypothesis. In addition, there are gender-specific issues that would not permit generalization of male data to the female veteran. CDC has also clearly stated that the proposed study is a "Vietnam Experience" study rather than an "Agent Orange" study, per se. By that, I mean we believe it will not be possible to estimate individual female veterans' opportunity for exposure by relating their unit's location to herbicide spraying missions. Like the "Vietnam Experience" study being conducted in males, the study of female veterans would compare the health of Vietnam veterans to comparable veterans who served elsewhere. Any of the exposures women veterans experienced in Vietnam, (e.g. stress of caring for a high volume of combat casualties, parasitic diseases, whatever Agent Orange may have been ubiquitous in the Vietnamese environment, etc.) might influence the health of Vietnam veterans compared to other female veterans. �Page 2 - Dr. Keller Given these two assumptions, that any health assessment of women Vietnam veterans should be as comprehensive as that in male Vietnam veterans, and that the study should look at all exposures in Vietnam, not exclusively at the opportunity for Agent Orange exposure, I believe that the study described in the protocol outline is appropriate. If the Science Panel can provide CDC with a list of specific hypotheses that will address the health concerns of female Vietnam veterans, I will request the resources to develop a protocol to study these hypotheses. I look forward to hearing from you in the near future. Please do not hesitate to contact me if you have any further questions. r, ~\": I Vernon N. Houk, M.D. Attachments �MOV T!) 19M Director Centers for Disease Control Possible Study of Female Vietnam Veterans Edward N. Brandt» Jr.» M.D. Chair Pro Tempore Cabinet Council Agent Orange Working Group Thank you for the opportunity to review and respond to the Agent Orange Working Croup Science Panel*• critique of th« protocol outline for a study of female Vietnam veterans. The Science Panel mentioned two Issues which they felt must be carefully considered before proceeding further with development of the study: 1) "the great potential for confounding exposures both during and after Vietnam to teratogenlc agents other than herbicides and their contaminants," and 2) "what a study of female veterans will contribute In the way of scientific Information which Is not already being obtained from the ongoing male studies." Cf»C shares the Science Panel's Interest In having a research plnn which addresses potentially confounding exposures* In this regard, it is important to consider the purpose of the study. As stated in the protocol outline, the proposed study is similar to the Vietnam Experience Study of men currently being conducted. All the exposures unique to the Vietnam environment, from parasitic diseases* to psychological stress, to waste anesthetic gases nay influence the health of the Vietnam veteran cohort. Agent Orange Is only one of many exposures Included In this experience. For analyses of the effects of Vietnam service in general, exposure to t-xcese waste anesthetic gases in field hospitals in Vietnam would not be a confounder of the association of Vietnam service with health outcomes. Rather, the anesthetic gases are but one of the many exposures that are part of the Vietnam Experience* On the other hand, for analyses focusing on specific exposures experienced in Vietnam, such as Agent Orange, waste anesthetic cfls exposure might be • confounder* Such analyses would be expected to control for operating room experience In Vietnam. Occupational exposures, Including waste anesthetic gases, experienced after military service might also be potential confounding factors since they could differ between the Vietnam and non-Vietnam female veterans. Again, these exposures would be considered in the analysis. To respond to the general concern about confounding, CDC would deal with potentially confounding factors in this study with the same approach used in the recent Birth Defects Study and the ongoing study of male veterans. �2 - Fdward K. Brandt, Jr., M.D. retailed Information would be gathered from personal Interviews and record revjf»we about potential conf minders, e.g., dorofirapltic, occupational, or other risk factor* for disease that might occur with differing frequencies among Vietnam and non-Vietnam veterans. In the analysis such factors would be controlled for, eliminating any actual confounding effect of th<:&e variables. The second concern of th« Science Panel related to the research questions urique to women thut would beflr'dreftsedin the proposed study. As fitatf^ above, the study is primarily designed to look at military service in Vietnam, in p.enrral, as the, «r.ain exposure of Interest, rather than estltiatee of /,pent Orcn^e exposure. Two caveats should be mentioned regarding the study of Apcnt Or/jT>£e exposure, per so, in relation to the health of feraale Vietnam veterans. First, because of the duties of t»oet women w^o served in Viet nan, thfir livelihood of erposure to Agent Orange may bo less than that of c-.ale Vletnan veterans. *o«t women who served In Vletnso ver*» stationed «t military horprtals cr headquarter units that were at some distance frora the heaviest <\f>fcnt Orange sprayings. Second, if, ns speculated by BOP.C scientists, A^cnt Ornpfle residues became ubiquitous throughout Vletnan, female Vietn*a- veteror.s way hav« been exposed throi^gh food supplies, drinking water, etc. 1'ofcovor, these types of expoBurcs could not be quantified by relating the prrotii.ity c.f the women'* units to the Ranch llnnd sprayinfc missions or other applications of A.r.«?nr. Throe ^road protipR of hoalth ontcoyfs would be studied In relattor to VJetvan norvicei reproductive outcone«, psychologic outcotaen, and gercral outconts for which T?otwsn may experience different risks than tnpn. ^productive outcomes would include fertility, spontaneous abortion*, con^enltol irnlforciarlono as well as dlRRawcc of fetr^lo reproductive Presnaney outcomes of the women are of pwrtJcular interest since maternal are more c.onnonly aesocfnted with adverfle effects than p«r«rn3l flseasps of reproductive organs nny be related to the Intiurnce of various stresses *nJ insults to the delJcate hypothalarjic-pitultrry-ovarlan ai:lp. Also of note in this repard, certain subclinical paraoitlc diseases, ns iralrria nnd acicbiasie, rsy becowc nanifewt during the f;trrt;n of outcoreo such as nnxlfty, dt-prrsslor, and font lYaur.atlc P rirord«r and hehrtvloral outcomes nuch no substance abuse and crininal activity r;ny crhihit different potternw In r.ole and frwnJc VlettJfln1 veterans. ^'Ith « .l»r^e proportion of acute care nnrses onon^ female Vietnam vetor.^nH, special c.o»>6 iteration would he given to possible ntr«sr.ft*l effects of curing frr a lorfc* volune of combat casualties. The psychosocial component of the fennle study is also crucial to the cowplete evaluation and interpretation of t heother clitics! data to he collected, specifically in the determination of outcwrs as a cause v«rnun on effect of plynlcal and Mochcrical (e.R. hepatitis, cirrhosis, memory c!lsorder&). f'enrrsl health outcooca would Include n vnrlety of conditions of concern to fenole vi«tnair. veterans* These outcomes are similar to those helnr. *ddr«BFct' IP tie ongoing study of trale veterans. An was the case 1n the study of p-alc v*»tcr«ns, there are few specific hypotheses based on previous scientific studies. CPC believer* that a comprehensive health Interview and physical exsii-« nation would he n?edcd f.o addrees the veterans' concerns thoroughly. �Page 3 - Edward N. Brandt, Jr., M.D» The Rtatifttlcal power of the propoeed atudy for Important health outconon would be good. Tha Interview phase of the study la designed to detect Increases of about twofold in the relative rieka for health outcomes occurrinr with the frequency of 0.3Z» while the examination phaae is designed to detect twofold incraaaea in conditions that occur with a frequency of 1*52 or greater (power * 0.95, Alpha * 0*05, J-tail). With that level of statistical power, moat conditions that ara of concern to women vho eerved in Vietnam will be adequately addressed. Only relatively email incraaaea in uncoeaon conditions would escape detection* The Intent of the atudy which CDC was aaked to propoaa la to address the health concama of female Vietnam veterans comprehensively and with sufficient atatiatlcal precision* That haa determined the study design and sample oize, rather than any single research hypothesis. The coat of doing this atudy la significant. A decision to do this resenrch, in a world of finite raeourc«a, aay aean that money for other activities may not be available. We ara neutrsl on doing the atudy* However, if a decision is made to proceed, wa ara confident that we can do a valid atudy, acceptable to the yetarana groups, if we are provided the necaaaary resources. We will he plen*«d to provide any further information you need. >**** Jamas ^rMaflon;"'V,f!#8fcP«H. Assistant Surgeon General cc: OD CEH CDC/W ES/PHS Tracer 85084; CDC ID D19247; CEH #B-59 10/19/84 CDC:CEH!CDD:AOP:PLayde:dd/doc �Minutes of the November 29, 1984 Meeting of the Science Panel of the Agent Orange Working Group The Science Panel of the AOWG met at 9:30 AM on November 29, 1984, in the offices of the United States Army and Joint Services Environmental Support Group (ESG) in room 210, Riddell Building, 1730 K Street, NW, Washington, D.C. Attendees were as indicated on the attached attendance sheet. The purpose of the meeting was to review in depth the procedures to be used by the ESG to assign an Exposure Opportunity Index to individual Vietnam veterans identified from other sources. Since the procedures had been developed during the CDC Birth Defects Study, individual records of Vietnam veteran participants in that study were available for review. Several individual records were selected to illustrate the information available and the method and steps used to assign an estimate of the likelihood of exposure to Agent Orange while in Vietnam. The method used in the CDC Birth Defects Study assigned a value from one to five to each veteran depending on the recorded proximity of his unit to an Agent Orange application while he was assigned to the unit. The value of the assigned index also took into account the particular job classification that the veteran had at the time. For example, a veteran whose job was either clerical, administrative or logistical would not be expected to be with his unit while on patrol away from the base, although he might be expected to serve guard duty on the base perimeter. If exposure consisted of a patrol approaching a Ranch Hand spray track, he would not be included, but if exposure consisted of base perimeter spraying, he could have been exposed. A score of five (highly likely to have been exposed) was assigned to all individuals in a unit which was known to have been within two kilometers within 72 hours of an Agent Orange application and who held military occupational specialties (job classifications) implying that they should have been with their assigned unit on such a mission. A score of five was also assigned to all veterans known to have handled Agent Orange, such as Ranch Handers or chemical personnel. A score of one (very unlikely to have been exposed) indicated that the veteran was assigned to a unit which was neither known nor expected to have been near an application site. Scores of two to four indicated a range of possibility from probably not exposed to probably exposed. Although the methods used to develop these procedures involved considerable subjective judgement on the part of the investigators, a description of the Vietnam experience contained in the records of veterans classified as "very unlikely to have been exposed" seems quite adequate to consider them as much less likely to have been exposed to Agent Orange than those classified as "highly likely to have been exposed". Members of the Science Panel unanimously agreed that the data and methods under consideration are adequate to classify many of the veterans into groups which were highly likely or very unlikely to have been exposed to Agent Orange while in Vietnam. Other methods for assigning intermediate values need to be completed and may best be adopted for specific studies where necessary. �Some of the implications of using the Exposure Opportunity Index as defined above were discussed as follows: 1) Some veterans cannot be classified because their records are not available or are incomplete. It is thought that this will be a small group if adequate search is undertaken. 2) Many veterans, such as would fall in groups two to four of the CDC Birth Defects classification system, cannot be unambiguously assigned to highly likely or very unlikely exposed catagories. Several suggestions as to how to handle these were: a) Classify them as unknown and drop them from further analysis. This would have rendered approximately one half of the Vietnam veterans in the CDC Birth Defects Study as unclassifiable. b) Use five classes (as in the CDC Birth Defects Study) or one or more intermediate classes. This system, would retain larger numbers of classifiable study subjects, but may reduce the statistical power of a study due to missel ass ifications. c) Attempt to classify all veterans with available records into likely or unlikely exposed groups. This is also almost certainly going to increase missclassification and therefor reduce statistical power. 3) The index as currently developed is intended to be a measure of the likelyhood that any exposure took place and presents some problems during analysis since it is not a dose response statistic. Using the computer methods now available, there is the possibility for counting the number of encounters a given unit may have had and trying to estimate the intensity of exposure. There is some support for this since almost all of the encounters which a given unit has had may be recorded in the quarterly reports (at least in those units which have been specifically examined). 4) There is clearly an association between combat and Agent Orange exposure since combat operations are a major factor in determining opportunities for exposure at the individual as well as the unit level. This must be considered in the light of specific study needs e.g., it may not have been relevant for a Birth Defects Study, but may be important in a Mortality Study. 5) While the methods which have been developed do provide for an estimation of the number of opportunities for exposure, there has been no attempt to quantify the possible exposure amount. The index only assigns a value to the likelihood that a given veteran was within two kilometers within three days of an application of Agent Orange. Whether this constitutes an effective toxic dose cannot be determined from the records and is the subject of ongoing health effects research. In order to assist in the usefulness of these methods for future research, a subpanel was assigned the task of developing guidelines for the application of these alternative methods to specific studies. The meeting adjourned at 1:30 PM, November 29, 1984. �, A - 357/ or 4 CASH / st.* 6. A 0 e? -rr U.S. �Department of Medicine and Surgery Washington D.C. 20420 Veterans Administration JAN 3 0 1985 In Reply Refer To: 10A7 Dear Colleague: Enclosed is a copy of the latest version of the Vietnam Experience Twin Study Protocol. These are being distributed at the request of Dr. Carl Keller—he will be in touch with you in the near future to arrange a meeting to discuss his plans for reviewing the protocol. Sincerely, BARCLAY M. (BHEPARD ,* M. D. Director Agent Orange Projects Office Enclosure � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1835 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Keller, Carl Title A name given to the resource Memorandum with several attachments: from Chairman, Science Panel, AOWG, to Members of the Science Panel, AOWG, with subject Meeting of the Science Panel, dated February 5, 1985. Subject The topic of the resource Vietnam Experience Twin Study AOWG ao_seriesIII