Update of Department of Defense Human Radiation Experiment Events, Reference Made to 109 Radiation " Events "

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SUBJECT: Update of DoD Human Radiation Experiment Events HQ, U.S. Army Medical Command, 2050 Worth Road, Suite 10, Fort Sam Houston, TX 78234-6010 1997FOR Director, Radiation Experiments Command Center, 1. Attachment 1 to basic memorandum made reference to 109 radiation Ilevents. Most of these lleventsllhave been determined not to have been experiments but contemporarily accepted procedures for medical diagnosis and treatment of disease/condition. Your references to the location of the Brooke Army Medical Center are in error. This facility is located on Fort Sam Houston, San Antonio, Texas. It is not in the city of Houston, Texas, as indicated in your references. 2. The information you provided on each of these cases has been cross-referenced against databases available to this headquarters. This includes clinical investigation and a literature search by the title you furnish and name of investigator/author where determined. Additional information obtained is provided with the respective description sheet for the RECC Event Number to which it pertains (Attachment 4 ) . 3. Results of these actions have been reviewed by the Chief, U.S. Army Clinical Investigation Regulatory Office, COL James M. Lamiell. His comments are provided at attachment 5. This information represents a definitive response from this headquarters, having exhausted all known sources of pertinent 4. Copies of your eight data sheets showing the reporting Command were forwarded with a copy of your tasking memorandum and attachments to MAJ Dale Vander Hamm, Chief, Human Use Review and Regulatory Affairs Division, DSN 343-2602 or Commercial (301) 619-2602. Follow-up on these cases should be made directly

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SUBJECT: Update of DoD Human Radiation Experiment Events 5. Our point of contact is COL Eric Daxon, Directorate of Clinical Operations, DSN 471-6612 or Commercial (210) 221-6612. FOR THE COMMANDER: Director, Clinical Operations

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Department of Defense Radiation Experiments Command Center MEMORANDUM FOR See Distribution AUG 1 2 1996 SUBJECT: Update of DoD Human Radiation Experiment Events References: a. January 3 1, 1994 Memorandum from the ATSD(AE), Subject: Locating b. June 14,1994 Memorandum from ATSD(AE), Subject: Expansion of Human c. November 2, 1995 Memorandum from ATSD(AE), Subject: Response by the DoD to Records of DoD Human Radiation Experiments. Research Review to Include Policy Making Activities of DoD Components. the Findings and Recommendations of the Advisory Committee on Human Radiation The above referenced memoranda outline a comprehensive DoD search strategy for the services and agencies to identify and retrieve all human ionizing radiation experiments (HRE) conducted or sponsored by the DoD from 1944 to 1974 (later extended to 1995). In developing the scope of the effort, a definition of an HRE was provided and the guideline to err on the side of inclusion was established to ensure that every probable HRE was identified. As a result of the search, addressees provided a total of almost 2800 events as possible HREs. In coordination between the services and agencies and the DoD Radiation Experiments Command Center (RECC), this number has been reduced to approximately 2350 HREs. The bulk of this reduction came as a result of follow-up review of background material forwarded by the addressees to the RECC. This review indicated some HREs were duplicates, some involved animal studies, some were not sponsored or conducted by the DoD, or that the experiment had been proposed but did not in fact occur. Such HREs were removed fiom the database with the approval of the submitting addressee. To ensure that the public has as complete a picture as possible about the DoD involvement in human ionizing radiation experimentation, addressees are requested to review HREs submitted for the pre-1975 period to ensure that all available documentation related to the conduct of the HREs have been forwarded to the RECC. Material required include protocols, contracts, reports, correspondence, researchers notes, journal articles, memoranda and any other documentation that bears on the conduct, results or participants in the HRE. A concise abstract summarizing the HRE must also be included. In this regard, attached is a printout of those pre- 1975 events originally provided the RECC which lack this essential information, primarily in the abstract. This information is essential and must be acquired and provided to the RECC. To assist in providing the requested information is an abstract format and a copy of an ideal event file submission.

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The full attention of each addressee is requested in this matter to ensure timely and thorough results. Addressees are requested to provide the requested information within 60 days from the date of this letter. Further, to facilitate the RECC expeditiously compiling the information, addressees are also requested make submissions on a phased basis . To accomplish this, each addressee should provide input NLT COB each Friday during the 60 day suspense Inquiries regarding this matter should be directed to Dr. Gordon K. Soper, Principal Deputy, ATSDWCB), at (703) 697-5161 or Colonel Claud Bailey, Jr., Deputy Director, RECC, at (703) 442-5675. Thank you for your attention to this important matter. FOR THE DIRECTOR: 1. Printout of pre-1975 event file 3. Example of ideal event file submission COL Layland, Assistant for Health Policy, Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs) CAPT Mendenhall, Officer-in-Charge, Naval Dosimetry Center, Navy Environmental Health LT COL Brown, Chief, Clinical Investigations & Life Science Division, HQ AFMONSGPT

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Observations on the mechanism of the renal clearance of 1 31-I I Con bsd Pro jed Protocol Numbers: Contractor: luuing Agency: Army Clinical Investigation Regulatory Office l mm tig at on Subject Type Raw/Ethnicity Documents w: No references found. clearance of 1-131. J Clin Invest, 34:1057-72, 1955 probably describes this Bricker NS, Hlad CJ: Observations of the mechanisms of the renal etudy . The study involved 49 adults and did not benefit the

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7. Pi cbtat~ceks been found 10 be hflucrwd at tnobt to a slight dcgtee by dccrwing rats3 of urine flow, over anngc iji inulin U/P due^ from 8 to 100 and a y p i CIJIJ not at mll by inemiring razes d urine f l ~ wovw e nulgc of inulin V/P values from 130 to 11. 8. In 1hc presence of osmotic diuresis tbe Jut/ inulin cicannce ntias inc read with dccrcrring inalin T:/P vaIue6. At i n atrapohtad inulin U j P ratio oi one, the 11'8//inulin elcarenee ratio 9. It ia concluded on the basis of the prtstnt studies that iodide, in the humn kidney, is filtered at the glomwlus and partially reabsorbed by the tubules. The data do MCsupport the pnrcncr of an active tubular tnnsport ruedunism, wu,d although this potrubility mIK)tyet be excluded, it is provisionally held chat idicic is tarhmrbcd p i e dominantly by passive trek-diffudon.

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Event Number: iACIR54000-B I Service: [Army 3Event Title: (Renal function and 131-I clearance in hyperthyroidism and myxedema Army Clinical Investigation Regulatow Office Invaotigators Subject Type RwelEthnicity Documents MEI)LINE: Bricker NS, Hlad CJ: Renal function and 1-131 clearance in hyperthyroidism and myxedema. J Clin Endo, 14:1539-50, 1954 probably describes -: The study involved 11 adults and did not benefit t h e

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Risks of fetomaternal hemorrhage resulting from amniocentesis with and without ultrasound Obstetrics & Gynecology. 46(4):389-91, 1975 Oct. Female Pregnancy Trimester, Second Pregnancy Trimester, Third The incidence of multiDle abdominal punctures, blood-stained aspirates, and fetomaternal transfusion was compared in patients undergoin amniocentesis at various stages of pregnancy with and without prior placental localization by ultrasound. A lower incidence of complications was found in'those on whom ultrasound examination had been performed. Use of ultrasound for placental localization in genetic amniocentesis. Obstetrics & Gynecology. 43(6):872-7, 1974 Jun. Cells, Cultured Pregnancy Female Specimen Handling Placental localization by ultrasound. American Journal of Obstetrics t? Gynecology. 106(2):279-85, 1970 Jan 15.

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and Tm mcasuremenb of cle6mnce were eirnultaneouely obtainod on nli prtienb. The clearance of Xu' was determined by the UM of 8 con- 'stant infurion technique, which allowed for atabiliPistion of plasm, lu' uuiny rtrndard continuour infurion clrannce tsche\qucr (8). h t d h of tho moth&

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me; wm uwd during the initial phslres of the study. For purpoass of plated into Tracerhb cupped plancheta in dupiiook pr t NrOH wsa dded to ewh plat8 and the ~ hte rwere ex in artlar tu attain flat and uniform>btq IVhan the gso were rediluted urd rubnquedy re-evaporatsd..Wlabeorption was duwmlntd on,et leaat two plum oo mph on erch patient by a method dovi,d in thin Irbsrrtory (IO), ' - whish dlowed for df-abnorption corraetions despite the h e ? h t $1" may havo alnndy bean praoont in tbe msterid.. Two d r o p of ,008MAgNO, plating salution were added to each plate and the mmplcr were evbprated to dryneur. NOcarrcrcliuoa for wlf-abeorption were found to b nbc m ry rt the dilutionempbyed. Pbma and urine p l ~ t a rwen oounted in I ) Tr*mrlsbAutonutie counting rate error did not ezcred 2 4 per cent for any rsrnpls. Gammu rariinLion NIU dotcrr.3ined on 2 m l . Jiqmtr ol plum and urina in s WdCurtu Sointindl Counter. Mparno was usually counted without dilution and urine w ~ ~ l l Jiluted 1 :6 in order t o obtain anittrt.inp r s k comparable ta tllom of ph8ara. Using Ma rtandrrd, the maximum loss due tb absorption nnd acattdt WM 1.7 per cent for p l u m ' *nd 0.7 p w oont for win*. No corrcctionh werc applid for thew errom Thefrrct\ond0.s counting ratu emr did not e x c d I .O per cent for any urmple. Inulin uudeterminedscconling torr modificationof'thcmethod of Rot dd,(ll),and PAH weordin# to the method of Smithst d. (12). & For beta a 4 ~ yon urjne, rhmples were dilubd 1:lo m d p h t 4 in 1-ml. qlaantitIu. I , Thc muib of initial rend function studiea on all ps]tknts, & ~umxnariscd in Table 1. URing group mean values aa the Rttandrud of reference, it ie apparpt tli& Btriking diffcmcce exiet; between the hyperthyroid and my%- In the hyperthyroid group, inuliri clearance value3 (C,,,)k g n d from , 119 to 156 cc./minute. The lowbat value Zor Ctnwae obtdnd in the py a n WBP 138 *cc./rninub-a figure appreciably above the. normal range, -obtained on 2 patients in thieLup and the valuea were elevated-hboth. Filtration fnctiona (F.P.)in the hyperthyroid pntienh ranged from 18 ta 28 per cent, with a mean of 22 pey cent. In contruat,to the gtmerally Ihcreastd value in thc foregoin6 prtiknb, a marked 'decreaffe wds noted in the primary modem group. Ciaranged . from 61.2 to 82.6 cc./minute. The mean value of 76.2 cc.]drruta'np nerrted R significant deprwion in glomerular filtration rate. C A I ranged from 318 to 470 cc./minufe, The mean value of 396 cc./minute waa abu tient who had received prior treatment. fncludity &libd&tcmi&tion, the - .

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clearance perid in an ixidividud patient.' The line repreenhitha h t linear function obtained by the leaat+quarm method. The corralation'@oefficient for all cam is 0.86. If the 2 patients with panhypopituitBhm @re omitted, the correlation coefficient ia 0.84. Both values are ubattrticslly significant. Further diecussion of this linear rcld,ionship will be t%uidered III,.E#e& of Lttfiodothyrm*ne an rendjundiun and Ianclearam ance-period colloctiona, covering an hour and half duratim, were 06 tainad. Tho reeulto of,thin rrtndy are shown in Table 2. No appreciable ' change in any nieasured function was noted. The second neries.of olearance rneanmiutdu was performcd after ti* days of daily intravmous admiuij.. tration of 100 pg. of triiodothyronine. The re~uItaof the follow-up rtudy ' am ohown in Table 3. The &inerular filtration rate inoremod 40 p r cent, * dTriiodothponine w u obtained through the oourhy of Smith, Kline and'Franch bbotrtoriw, whn nhkinad it from Glaxo kbornbrier, where it WM ayntheriled.

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hypopituitarism and probable secondary hypothyroidism. Glomerular fib tration rate, renal p b m a tiow, and TmpAR value8 were elevated in the byperthyroid group end depressed in the myxedematous group. Followhp tnerapy in 1 hyperthyroid patient, renal functiow were revelged toward glomerular titiration rBte increased despite B fall in rend plnsme flow, tous patient for a period of six days induced a striking increw in rend glomerular filtraliw r o ~ eand renal plasms flow. It has bcen oonciuded that the Rtata of thyroid activity exerb a definite effect on renal Ram+ dynamicr, and tubular function, . hss been found t o be a linear function of the glomemtrrr fiitrstion rate. Thun, because C p variaq with inulin clearance (C1.); C p it3 increased in hyperthyroidism and dccresaed in myxedcms. It should & cmphaaimd that the valuets for C p in both groups of patients arc compambb t o thme obtained in edhyroid subjects having the same range of glomcrular Alfration rates. Although triiodolliyrwina in M untreated rnyxedomataur patient, and TSH in a treated myxkdematoua patient, produced an incre-e in C p out of proportion t o the :ncreIsBe in CLmlno definite evidbnce ofliti nctivc tramport mcclianivrn for iodide was obtainad. Xt has boen proviaionally coacludcd that the fitate of thyroid activity influences the rerurl excre- e , apparent specific influence of thyroid or thyrotropic hormone at the &buThe authon gratefullyacknowldpo the generosity of the following: Dr.Harold Elriok for E.is cooperation in obtnining patimtrr and his helpful auggationo; Dr. Joraph Boimea for hir rugjpattons;Jack F w n for all photographic work; and Ronald UnlUweIl, Chlorlae 1, AAB,K.,and BLSOEN,E.:The r c d blood Row nnA the glomerular filtration rito is 3. VARQA,F.: Rclation of oxygen oonaumptioo and renal function in I i y p ant! hypcrthyrroeis, Ada nudica Ad mi as reiml. Aungrrrlcac. 3: 37B, 1032. POWPIU,MI.€1.: Tlrl: effect ul varying rlumti!ier of inorganic i d i d o (oarrisr) on tha urinsry excretion md thyroidal accumulationof radioiodine in exophthalmic goiter, - 4congestivehart failure and Rome other clinicd dimrtlon, Bcandinau. J . Clin. 4 tab.

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ing function ai tho thyroid gland in euthymid rak d the tiuiiuui Chyamicl, Clin. 8 s . 9: 421, 1060. '1. & malar filtration mte cif iodide, (to be pubhhedl. The rend clwrana, of aubrtrtatad hippuric reid d rfvntlvea )nd othw uruadt; minrtione uf 1"~md inulin oloat*ncea in wrying ata A of thyroid and renal fun+ failuq of thy tion of pubcr had had rymp urd a few dry; opent two yen rpa in other 81 . ical. In addit the hip bones genod af an 8tory of cold i t

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Event Title: Platelet transfusion - efficiency and methods to improve current results in thrombocytopenia Brooke Army Medical Center IHouston ITX (USA Army Clinical Investigation Regulatory Office Investigators Subject Type RaeeIEthnicity RECORDS: None available. w: No references found. MEDLINE: No related citations located. This study did not involve ionizing radiation.

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Evaluation of renal function utilizing radioiodine labeled Diodrast Army Clinical Investigation Regulatory Office RECORDS: None available. n: No references found. MEDLINE: No related citations located. MEDICAL: The ionizing radiation associated with this study was employed only f o r medical diagnosis.

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WITH THE TECHNICALASSISTANCEOF VALENTINEBIKERMAN After the administration of IlJl-labeled Diodrastt (iodopyracet), there was sign iw nt hepatic uptake and retention of the labeled materia2 which,interfered with the evaluation of function of the two kidneys by an external monitoring technique. The prior administration of carrier, o r unlabeled, Diodrast (1.0 Gm.) eliminated hepatic …