Impessions of the Technical Repesentative

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The study should be continued in the following manner. There is need for continuous monitoring of the health and mortality of workers in the industry from the standpoint of operational safety,labor relations, workmen's compensation and public relations. accumulated for this purpose must be analyzed ; the data collection and analysis should follow sound epidemiologic and statistical principles. The observation of a human population exposed to relatively well documented doses of radiation is a potentially valuable scientific byproduct of this program. Contributions to occupational epidemiology may also be expected. The position of DBER is that the collection of health data on workers is an operational responsibility.This principle has been:t accepted by operational divisions, and the costs ' of collecting current data are or.wi.11 b e assumed by the Divisions of Production,Reactor Development and Technology, and Military Applications. DBER should continue to be responsible for designing the format of data collection and for analyzing and publishing the scientific results.Expenditures by DBER for this purpose should decrease as development ofthe methodology allows much of the analysis to be performed as a routine operation. 2. Performance of the contractor(strengths) a.Careful design of data collection The data collection has been meticulous, and the contractor has exercised an extra or d in, ? ry degree of quality control.Exhaustive efforts have be.en made to fill in for nation gaps and to correct errors.

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b.Diligence in seeking biases instead of ascribing cb served differences to radiation effects The team has been conscientious in seeking explanations for observed differences between comparison groups that might have been ascribed improperly to radiation effects.In so doing, they have uncovered biases that might have been ignored by investigators who were less careful or who sought spectacular c . Improved resp on st ve ness Tne team has been more responsive to AEC requests in the past year than previously. During this time they have produced analyses involving comparisons of Hanford employees with siblings for specific causes of death and are actively working on a grouping of workers based on their level of radiation exposure.A recently submitted,semiannual progress report is closer to the desired format than any previously prepared by the investigator(enclosure4). Drs. Mancuso and Sanders have repeatedly announced an objective of seeking very fine differences in longevity between worker and control groups. In so doing,they have ignored possible biases in the control groups that make such fine distinctions meaningless. Furthermore,they have used this objective as 8n argument for expansion of the population under study. Expansion of the population is a worthy consideration but would not guarantee achievement of their objective.

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b . Poor progress and lack of initiative The study has been conducted at an inordinately s10.c~ rate.A commendable concern with quality of data has been carried to an extreme that has seriously impeded progress of the ::udy. Any analyses conducted to date have been made only in response to pressure from the DBER staff. In spite of an established reputation in occupational epidemiology, which was the reason that he was approached by AEC t o ser,le as investigator.A tendency to refer bl.1questions concerning technical information to Dr.Sanders reflects an inadequate knowledge ofthe study.Dr. Mancuso does not function as a public expos it or of the scientific aspects of the study but usually ' confines his remarks to questions of funding with emphasis on AEC deficiencies in this Dr.Sanders is a sincere and generally respected actuary with considerable experience in the Social Security Administration and i n HEW along the lines of the work he is doing in the study.He is the moving force in the study despite his advanced age. Much ofthe work accomplished to date should be credited to him. His weakness stems from alack of general statistical,epidemiologic and radiologic functions as the scientific spokesman for ' the group.He is also the principal writer for the study but ' has produced on iy lengthy,rather poorly written reports and no scientific articles.

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Dr. Brodsky isa young, health physicist with a voluminous curriculum vitae and a recent D.Sc. in biostatistics. Reviewers have judged his statistical input to the study to be atrocious ; however, his statistical role has diminished.Dr.Brod sky ' s health physics reputation is good, but he has not imparted any aura of radiologic sophistication to the study. Dr.Elst on is a recent addition to the team as a statistical consultant.Heisa sound bio statistician from the University of North Carolina and has improved the statistical methodology. The reviewers expressed regret that Dr. Elst on or sorneone else ofhis stature is not more extensively involved in the study. The project suffers from undue physical separation of the principals in the conduct of the study. The central office is located at the ofthe team from San Diego; the computer center is located in Oak Ridge. At the very least,the individual responsible for analyses(Dr.Sanders) and the computer should be in the same location. Several lengthy annual reports and a recent,long,un refereed report in a Health Physics Society Symposium Proc ceding s are theo ~ l y publications produced thus far.No articles of reasonable size have been sub n it ted to scientific journals. The investigators ,ere apparently waiting unt51the analyses are completed t o make their

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Alternative courses of action 1. Retention of ' the contractor Retention of the contractor without change would b e an unsatisfactory solution. Although increasing progress is being made in the aca lysis of data and production of results,the unrealistic goals and weaknesses in their understanding of radio bio logic considerations and in their capacity for 2.Early replacement of contractor Such a move, although justified on the basis of perform an ck, may have Unless an immediate replacement is folind, a public charge may ben a de that the AEC is stopping this program out of fear that positive findings wille ner ge. Fi'nding a suitable replacement under existing conditions is handicapped by general - knowledge that this is Dr. Mancuso's project and that any new principal investigator will be replacing Mancuso (and, by implication, putting him out of ajob).Overtures to possible candidates must b e carried out now in, / clandestine atmosphere. Under these conditions, potential candidates will be unable to learn enough about the study to develop carefully prepared proposals that may be judged fairly to arrive ' at a proper choice of a contractor.Furthermore,the large amount o f work performed to date using Dr. Mancuso's methodology, may be jeopardized by a new investigator ' slack of familiarity with that methodology o r by poor coo ? e ration of the Social Security Administration with a new 3.Orderly d is enga gc nen t Tn is is a proposal to retain Dr. Mancuso as contractor for the

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completion of two specific p.ro j ect s -- the Hanford and Oak Ridge analyses and the master file or employment i n AEC plants.Atime limit of two to three years can b e set for the completion of these activities with a diminishing budget projected as different parts ofthe work are completed. Com?letion of these projects by Dr. Mancuso's teain will require continuation of trre recently increasing sur veil lan ' ce of the study by DBER personnel.We will exert a major effort to make Dr. Mancuso's completion of the Hanford and Oa!c Ridge Studies productive of results useful to AEC. . . Inthe meantime, in for in a2ion can be disseminated to the effect that (a) the study will be extended to other AEC plants on a prospective basis ; (b) concr act proposals from other investigators in corpora cine alternative methodologies will be considered along wi.th a- new proposal from' Dr. Mancuso; and (c)that consideration will be given to splitting the current single into multiple contracts in vo ~ vin gd is tinc t spheres of expertise such as epidemiology and health physics.Implicit in all of this will ' be termination of the open-ended, exclusive character of Dr. Mancuso's contract. The latter point can b e made explicit. The third alternative is recommended for the following reasons : 3 &. It will continue the involvement of Dr. Mancuso in the study,atleast temporarily, and there by secure a measure of cooperation from him during a transitional period. It will obviate potential a i verse criticism that might follow an3 b. abrupt tc rm in z tion of the contract. ' Provision will be made for completion of the projects cited above i n9&. which a large investment has been made.

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-d., Time and favorable conditions will be gained for a careful consideration of alternative approaches to the further conduct of this long-term study so that it may be pursued with greater effectiveness in the future.

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SUMMARY OF COMMENTS OF REVIEWERS The review team consisted of three epidemiologists from various universities and an epi de mio logi st and a statistical epi de mio logi st from In the following summary prepared by the DBER technical represent aci ve an attempt is made to collate the attitudes of the reviewers relative to specific issues. The four reviewers considered here are those who have submitted written reports. The letters of the reviewers are avail.able 1. Continuation of the study Three reviewers enthusiastically recommended continuation of the study ; two of the three favored expansion bo include other AEC installations.A fourth reviewer did not consider this matter. One re vie yer recommended retention of this contractor and his team but expressed some reservations about Dr. Brodsky. Another provided contradictory comments i a ' that he cited agreement by the review team " that the University of Pittsburgh should continue as the contractor " but then offered several personal reservations "which may well be cause for considering an alternate contractor ." His specific reservations included such comments as "no over ali direction ' ' of the study, "minimal involvement in this project by the P.1." and " paucity of the results. " He finally asked whether it is possible for the AEC to alter the, open-ended character of the current contract.A third reviewer recomziendcd that another contractor, ' prefer z bly from a univers l ty Department of Epidemiology,be found to serve as the principal invest ig Lt or. A fourth reviewer did not consider the matter of retention of rep1accmcr.t'