1 15 4 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 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/ddb47a7c5683bdd8139fc45091e36dde.pdf 808eb9c3a4ebae9d46520a70556c871e PDF Text Text Item ID Number 01692 Author LeVois, Maurice E. Corporate Author Typescript: Agent Orange Status Report, June 25, 1982 Journal/Book Title Year 000 ° Month/Day Color Number of Images n 3 Descripton Notes Monday, June 11, 2001 Page 1693 of 1793 �June 25, 1982 Maurice E. LeVois Administrator Deputy Administrator Agent Orange Status Report Status report on the aianaqeroent of the V& Agent Orange Epldowioloqy study, and the matter of whether to include a third cohort in the deaiqn of the study* Uo final decision has been reached on the question of in-house -vs- out-house conduct of the Vft Aqent Grange epidemiology study. We are exploring options and evaluating the level of interest, and capability, of potential scientific contractors and other government offices the VA nd<jht engage to conduct this study. Du* to the lengthy scientific review process, ther« r«raain conflicting views about some aspects of the protocol, *!'he»e differences nust be reconciled before we c«n proceed to a final decision about who will actually direct the scientific investigation, Our next step in to hire •« itmall VACO scientific staff and, with the «i<3 of consultants if needed, to begin the final integration and completion of the UCLA protocol. Thi» will be done raore quickly if vm also involve the scientific review committees in this process and if we identify the scientific oversight panel which will follow the progress of the actual research, M the sane time the protocol is being completed, wo will seek to identify potential inventigators for the pilot study. We are currently developing a Request For Proposal*? (tin*)* and a contract statement of work, so that we will he able to ben in the pilot study as soon &ss possible after the protocol is finished arid approved. W© hope to conn it PY 32 funds to the pilot study and to begin data collection earlv In 1983. �II. Third.Cc?ho|:t» The &OUG £ci«nc« Panel has recoraraencled that the VA'a f epidemiology study Include a third cohort in or<3©r to look at the broader Issue of possible health effects resulting from service in Vietnam, Selecting appropriate health outcomes to adequately represent possible health effects of the "Vietnam experience", rather than only Agent Oranqe effects, has b«*n mentioned by OTA as a potential problem. It is not too difficult to address this issue. The range of health data included in the UCLA protocol is already very broad, Th® authors note that their choice of outcomes to bo eKamine-d relief na much on press reports of Vietnam veteran's health problem as it did on the .limited scientific literature on the effects of exposure to phenoxy herbicides (Appendix G of the tICLA protocol). If the VA is prepared to conduct an expanded health evaluation, then health outcomes of interest representing tho entire "Vietnam experience" could be built into the study. Representative sajaplinq is e problem not so easily addressed. There are really two related problems in this area. 1) The UCLA authors have pointed out that Vietnam veterans who did not go to Vietnam may differ in important ways froro those who <3JU3 serve in Vietnam and survived. Hot^ they might differ is not explained. It is reasonalbe to suppose that military training, physical fitness, willingness to take risks and the proven ability to survive a war, are four dimensions v/hich could contribute to very different health profiles for the Vietnam and non-Vietnam groups, having nothing to do with exposure to Agent Orange. This problem, of finding a perfectly comparable third cohort, can never be totally solved. It will be important to identify and evaluate the potential size and direction of health differences thought to exist in these groups before we proceed with a third cohort. 2) Another sampling problem arises when we atenipt to conduct both a "Vietnam experience" study, and an Agent Orange study, using three* cohorts. The? hiqh and low Agent Orange exposure-likelihood cohorts nust be as similar as possible on all other factors which cannot be objectively measured. Combat stress is one example-of an important potential confounding factor which is difficult, to meanure �at the level of the Individual soldier. Combat stress should be controlled by selecting both Aqent Orange exposure cohorts from combat units thought to be equivalent in terms of exposure to stress. Idally, the high and low exposure cohort® should be equivalent in every way except exposure to Agent Orange, Unfortunately, this approach reduces the generalinability of the study. If only combat veterans are sampled,j«»t a fraction of all the troops who served in Vietnam will be represented. Do the high and low Agent Orange exposure cohorts, as presently defined in the protocol, adequately represent the "Vietnaw experience" (i»e, all of the health risks encountered by Vietnam veterans)? I don't think so. However, with careful cohort selection, and very clear cohort definition, th® "Vietnam experience" represented by subjects in the two Vietnam cohorts could represent the most salient aspects of that experience. The AOWG Science Fan«l ha« recomnendcd a balanced emphasis on both the broader issue of evaluating all health risks ansociated with service in Vietnam, and the narrower question of th® effects of Agent Orange, This will ultimately require some compromise in the design of both studies. This will also require further delay while these issue® are debated, encorporated into the protocol, reviewed and approved. � 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. 1692 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: Agent Orange Status Report, June 25, 1982 Subject The topic of the resource Agent Orange Exposure Study ground troops exposure cohort study study protocol ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/022d8dd82d8c5d8826fd95aa20d66653.pdf 169ccc7a00926fd451edada964ea867c PDF Text Text Item ID number 01 689 LeVois, Maurice E. Corporate Author ROpOrt/ArtltiO TitlO Memorandum: Agent Orange Epidemiology Study Design, from Maurice Levois to Deputy Administrator, April 29, 1982 Journal/Book Title Year 000 ° Month/Day Color Number of Imaoes G 2 Descrlpton Notes Monday, June 11, 2001 Page 1690 of 1793 �Veterans Administration Memorandum To: Date: April 29, 1982 Deputy Administrator (001) Agent Orange Epidemiology Study Design The most recent draft of the University of California at Los Angeles (UCLA) Agent Orange epidemiology protocol proposed that two cohorts be selected and studied. These two groups would be comprised of Army and Marine Corp troops who served in Vietnam from 1967 - 1969. One cohort would be comprised of subjects with a high likelihood of exposure to Agent Orange, as described in the exposure likelihood appendix to the UCLA protocol. The other cohort would be comprised of subjects with a low likelihood of exposure to Agent Orange. Twelve thousand individual's names would be selected initially by the Department of Defense (DOD) for each cohort. This list would include the names of deceased servicemen as well as those still living. The life status and location of each individual would have to be determined. Prospective subjects would then be contacted and recruited, up to 6,000 subjects in each cohort. The Office of Technology Assessment (OTA) and the Agent Orange Working Group's (AOWG) Science Panel have reviewed the UCLA protocol and have both recommended that a third cohort be added to the study design to determine whether or not service in Vietnam has caused any health problems not directly related to exposure to Agent Orange. The third cohort would be comprised of 6,000 veterans of the same time period who did not serve in Vietnam. The health of these veterans would establish a baseline for comparison with Vietnam veterans. This third cohort would allow researchers to evaluate possible effects of service between those who served in Vietnam and those who did not serve in Vietnam, in addition to the possible effects of exposure to Agent Orange. Since the health status of subjects in all three cohorts would be evaluated in exactly the same way, the addition of a third cohort would increase the cost of the study by one half. �Page 2 Deputy Administrator (001) Comments and recommendations made by the review groups have been forwarded to UCLA for their consideration and final revision of the protocol. The revised UCLA protocol, due to be returned to the VA today, will be reviewed again by the committees already mentioned, as well as by the National Academy of Sciences (WAS) and the VA Advisory Committee. UCLA's recommendations regarding the cohorts will be carefully considered by all of the reviewing committees. The final decision on this and all matters relating to the epidemiology study will be made by the VA. MAURICE LEVOIS Director, Agent Orange Research and Education Information � 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. 1689 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 Epidemiology Study Design, from Maurice Levois to Deputy Administrator, April 29, 1982 Subject The topic of the resource Agent Orange Exposure Study ground troops exposure cohort study study protocol ao_seriesIII