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Rsformnm PAPER RCCl.960618.01 0 SGRD-RCQ 18 September 1994 rsFoRmnm PAPER SmJXT: V. 6. w Drug Testing Prom Involving )~urpsa Subjrcts During the 1S5Ois, 19601r, and 1970fe 1. ISSUE: Congressman JoW Conysrs, Jx, Chairman, Legislation and NationaL Secuzity Subcommittee har requested of the Department of Defaaae LnfOWtion far testimeny on 38 Sop 94. The Office of Tha Surgeoo General of tha &B been requested to provide informatha on the eubject liae nota4 above. 2 . FACTS : a. -ROUND: Biomedical rrrearcb tograms ue, tha OldeSt research programs hi the Anntd Forces witE their beginnings in the esz~yiaoofs. -the 1800ls le- up ta am iPso*a the military wag hvolvsd ha amy rograras testing drugs an8 vaccines irr huFMn subjects, a 8 ort,list iolloyo: alaPOX vaccinrtioas, gastroimtertinal Kstudses, yallar fevmr atutUas, the deytelopanenc of an effectLv* antityphoid vaccina, the development of cbAorine to purify drinking wafer, the use 02 emetine to treat ~ysantery,the brlvalagmanr! of I rabiee vacciae, the UB~OS Atabrine (puhacrine or twpaoriaa) MS teated ~LIa subrtiute tor quiniae in cambating aulasia, large rcale produetian of Western and Eastera equine eacapbalitLa began and Che LitSE Cue of typhoid ievor witn chloraaphenkol vas reporta. IXJthr 1950'~aad 19601s the military in particular studied md patticipated 5n developarcnt of a safe Venezuelan ~quin. BncrphaI.iti6 vaccine aad an or81 adenwixuo vaccine. Sulfurrylwr, an antibacterial Cream was dav85aprd for the treatment of gseudoamaa Uectioar; in bum patiema, The extensive invelvemsnt in Viet Nam rrquirrd m~yStUdfO8 dth antibacteria3 and aatimalauial drugs Uvolving service member6 in 02 retudng f endmic bfoai. In the lata 60's and earlier 701s studiee wsconducted uihg grrmpa globUin for prevurtion of bepatitis. Zn 1976 the use of acetazohrdde for Acute Uouatain Sickness was ValibaCek. During the 1970'9 Ln PaXticUlU, mulri lo ocher clinical inwsrigatioab: with the rise of antibP o~Ic8 (carbenicflLb, tetracyclhes, etc) and other drugs (antacid8 aad cimetidine for: Curling's ulcer) wail4 also taka plrce parallel EO that in tb. civilian oomtunity. Certain rtudieo during the cold waz ora haw captured mch attention. StUcs Opitb malaria and prisoner. took place frum 194s through 197f, Project White Coat bsgan testing products for bbl fcal CLetensr Lrorn 1954 thmgb 3973, the fhst U.S. Any Caca1 CS-9 rtudie8 with b-lyawgic acid dicthylatdde (w) other Izal1UClpog~CbgS, 88( Ud Scl8WldS@, and cmsarreially avai1abL.e approved dags be* ia tha early 19SO's and csntiaued tbraugh L967 Zor UP, a957 thruugh 1969 for BZ. md 'LO60 rhtough 1971 for acopOlBoLirre, The foll- psragrrphs will 1 J IIQNRDAL SCRb-RCQ describe these three major cold war drug testing programs. '.c- b. MALARIA RESE4RCH: The U.S. Government sponsored malaria research involving prieoners from 1945 chrough 1975. The urgent peed was created by the Japanese attack on Pearl Harbor. practically all the world supply of quinine was denied the allies by that event; and its consequences. The actual magnitude of the malaria problem in World War I1 greacly exceeded even the most pessimistic prediction of the time. In response to this need, the CammLtCcc on Medical Research of the Office of Scientific Research and Development, National Resear'ch and sponsored Council, organized the malaria J drug development program. The U.S. AmtY Wa6 cooperating federal agencies. The great was realized in the discwery of chloroquine, a drug with rapid and unsurpassed antimalarial accivity until the development of resistance in the mid 1960's. world war I1 an8 the later 1940's several sites the testing new compounds. The U.S. Anny was primarily involved with Stateville Penitenthry, Illinois. Prom the onset, the use of prison vdunteers was open to public scrutiny as evidenceU by an editorial in the New England Journal of medicine in March 1945 and other public observation of the program. The volunteers were white male inmates, 21 co 45 yearc of age and in good physical health and mental health. They were cognizant of the nacure of the experiments and weye able to - remain under observation for 18 months. Volunteerism was popular and there was an associated air of patriotism. nore prisoners volunteered than could be accepted anto the pragram and they were prmisad no special privileges or reward. At the end of wW11 Illinois Governor Green appointed a civilian comrnlttte of health professionals, clergy and businessmen to advise the Departmant Of Public Safety relative to the ethical principles governing conditions under which prisoners might be permitted to sene as subject8 for medical experiments. Their repart was published in 1948 and reiterated che principles of the Nuremberg Code. The Cmitcee concluded, "An example of human experiment3 which were ideal because of their conformity with the foregoing sthical rules are the experiments at Scateville. In the 1950ts/~interest in malaria research was # 9-4 by rha Korean War. U.S. JUmy support for research involving prisoners at Stateville was augmented and led to the discovery of Primaquine which to this day 1s stall a vital component in the anti-malaria drug armamentarium. fn the 1960's the discovery of chloroquine-resistant malaria in Southeast Asia initiated the need for new effective anti- malarial drugs. III addition to Scateville Penitentiaq, additional facilities for clinical trials Of new drugs were required. In 1963 to 1964 studies were initiated under government contract at Kansas City Jail, University of Missouri, and Maryland House of Correction, University of Maryland. As an 1 2 09/19/94 17:05 S . @IO04 OS/lE/B4 22:06 Dl 301 Blfl 7803 .. BQMRDAL SGRD-RCQ 0loo4/ooa 4 Integral part of cheir cmtract the essential elements of AT Regulation 70-25)were includad. ma additional facilities were used briefly in the early l37O's, Oklahoma Stace Prison at 5''opdMdester, Oklahoma, and the Florida Cotrecclonal Institutim, ;I%'- 9 (University of Florida College of Medicine). The u.S, Army ' Investigational Drug Redew Board approved each study and insured that the potential volunteers were! informed as to the nature and hazard6 of their participation in the studies, and that they were allowed the right to withdraw from participation without prejudice. All of the U.S. Army prison programs were stopped in 1975. Alternative procedures for continuing antimalarfal drug testing in free living volunteers were subsequently develope4 by rhe Walter Reed Army Institute of Research and are active today. The U.S. Army worked with approximately 7000 prisoners over the periaU M 1945 to 1975. We haae(been to14 that there were three cisathis: during the cwq early years; one -own cause, one a prison assassination, and one case of acute leukemia temporally related to participation in the program. Since the U.S. Army has been directly involved there was one additional ca5e that may have been related to mlaria infection or his treatment. Briefly, this man was with with quinine, infected malaria, treated responded normally 7- with eradication of parasites from his blood H%o >U developed L' He died about 2 months later from sept icetnia peritoneal. dialysis. The pathologic diagnosis was TTP, & obscure disease of unknown etiology: I C. LSD. BENZILATE (BZ) AND SCOPOLAMINE STUDIBS; The remarkable hallucinogenic properties of lysergic acid diethylamide (LSD) were diercoversd in Switzerland in 1943. In the 1950's LSD at first glance seemed to possess man roperties desirable in the llldeal" chemical warfare agent % a humane weapon temporarily disabling enemy troops so they could be captured unharmed. It was known to be effective in incredibly small amaunts and conveniently colorless, odorless, and tasteless. Because of these properties, in addition to the rumored use of LSD or emsimilar agent by the Soviet bloc nations for the purpose of Interrogation and behavioral control (brainwashing), the U.S- Army Chemical Corps and the U.S. Anny Intelligence Corps decided to conduct a series of experiments with LSD. These tests began in 1955 and continued through 1967. volunteer research subjects were solicited fram the Amy in general and from the Chemical Carps. Mistakes were made involving ths process of informed consent in some cases vhere the subjects were volunteering for research but were not told they were in drug research or if they did know they were in drug research they may not have been told what drugs they were taking- All available evidence indicates that with one exception with the initial Intelligence resting, LSD-exposed subjects voluntarily participated in the chemical warfare testing and were inforrued ahead of time that they would be receiving a psychoactive agent. - The question is not whether the subjects volunteered, but whether 3 09/19/94 17:08 '8' @lo05 05/18/84 22:07 301 610 7803 el ECHRDAL SGRD -RCO @OOS/OOS they were provided sur ficient information to permit an - enlighrened decision. Strict medical supervision was provided during the testing and& rior to the actual receipt of the drugs. Almost: all Subjects receE ved some degree of psychological screening and 30 to 50 percent of the Army vdlunteers were turned down during the ncreening process. The bulk of the testing was carried ouc at Edgewood Arsenal, Maryland, although other sites such as Ft - Bewing, Ft. Bragg, Ft . McClellan and Dugway Proving Ground were Used occasionally. Projects were designed to obtain information tlot only about the possible usefulness of LSD in operations against an enemy force, but also about means that eght be taken to defend against the use of LSD to disrupt u.S. forces. By, 1967, the necessam data had been obtained and further LSD research was discontinued. The civilian cmnity over these same ysars was testing LSD On a much larger scale- On 28 July 1975 Acting Secretary of the Army Norman R. Augustine suspended tasting of chemical compounds on human volunteers at Edgewood usenal.
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