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707571 Department of Energy Oak Ridge Operations P.O. Box E Oak Ridge,Tennessee 37830

BBCSIM~LESEBvICsS pmlc n (snc XmJm mS. 626-3063 Cm61 5576-3063 9600 6264573 CtMM, 614-576-0S73 TEmPEmE VeBDIcaCpIm m. FTS. 626-lOS8 88 1057 C~RQL 615.57~10~s m:September 22, 1981 Wayne Range, Asst.to Mgr. for . Public Information BE, mDIV. DOE/ORO

Ray Marble, Office of Congressional,Intergovernmental, r and Public Affairs, DOE/Headquarters 252-2773 M: Forre s tal Building (rn. ) mm08 I#cCA!noa _- HOW

BY HOWARD L. RQSENBERG

I11ents and consultations with leadi% medical and scientific authorities relreal “sea of radiation.’’ that these treatments ellollred into mnknown to Mary Sue Sexton, her something quite different: son Dwayne was serving as part of a e The Oak Ridge Institute, where government experiment: He was help- ing to find the parameters of the radiation sickness syndrome-precisely how large a dose it would take to cause a experiments on animals and humans. ‘person to lose his appetite, get nauseous B) Leading authorities on radiation and vomit. protection, and even rlie AEC ifseljin its review of these experiments, judged that the treatnlellts were Of little, if any, benefit to the patients. The lllall who Oversaw the experimcnts, hO\\’-

. ever, is today one of the government’s chief experts on the Today Oak Ridge’s broad, main avenues are still lined effectsof radiyt‘< ion. with Army barracks, converted and refurbished as apart- o The government doctors administering the treatments ment buildings. The “downtown” area is a modern shopping knew of other therapy techniques-using either different center. The denizens of the “Energy Capital” are a curious types of radiation exposure or chemotherapy-that were mu of rural-tired hill people and scientists and technicians superior. At least in Dwayne Sexton’s case, the government from around the world. One out of every 35 Oak Ridgers scientists at Oak Ridge initially withheld these better- holds a Ph.D. degree-one of the highest per capita ratios in established cancer treatments. the nation. 1 0 The clinic facilities were “substandard” according to the Clarence Lushbaugh arrived in 1963 to head the AEC government itself, 2nd the AEC eventually forced its own clinic’s ominously titled “Applied Radiation Biolog)) Divi- clinic to close down. sion.” A short, balding man with a combative personality, o Patients did not offer their fidy informed consent to be Lushbaugh likes to say he “grew up in the gutters” of Cincin- part of some experiments. nati, Ohio, where his name, And some patients, like Clarence, “was a fighting Dwayne Sexton, were sub- name-you had to protect a jected to several different name like Clarence.” Most types of experiments. of his friends now call him e Though the treatments “Lush,” but the feisty atti- were administered as can- tude of his youth has not cer therapy, one primary inellowed much in G5 years. purpose was to obtain data The nameplate behind for the United States’ space Lushbaugh’s desk informs ram on human reac- visitors that he is the HSOBIC-Head-Son-Of- a-Bitch-In-Charge. Educated at the Univer- sity of Chicago, where he NASA, the National Aero- received his bachelor’s de- nautics and Space Adminis- gree, a P1i.D. in pathology tration, urgently needed and an M.B. in medicine, data on human sensitivity to Lushbaugh began his career radiation, and the cancer in 1S49 as a pathologist in patients who came through Los Alanios, New Mex- the doors of the Oak Ridge ico-another “atomic city.” Institute of Nuclear Studies He doubled as the govern- became the human guinea ment town’s coroner. In pigs who provided th; information. 1963, Lushbaugh moved to rural Tennessee and became a Animals had been the first to breach the boundaries of member of the staff of the Oak Ridge Institute. space. Dogs and chimpanzees and monkeys were metamor- “In Eos Alamos,” he explains, “we had plenly of radioiso- phosed into avian creatures, hurtling through the strat- topes and plenty of machinery, but we didn’t have a wllole lot osphere atop rockets. Down below, scientists were wrestling of sick people because it was a rather young population.” with unanswered questions about how human beings would Oak Ridge offered the same access to radioisotopes plus a stand up to the effects of radiation. Nausea and vomiting large group of Tennesseans who were gratefui for frce medic- caused by radiation sickness were possibly manageable ail- al attention at the AEC clinic. ments on the ground. But to an astronaut wearing an oxygen The Qak Ridge Institute had a mandate from the Atomic mask, they could prove fatal. Energy Commission-which was then the governnlent agen- Hard data on human radiosensitivity was vital to NASA. cy charged with promoting nuclear energy-lo conduct re- But who would volunteer to be exposed to potentially lethal search into the “beneficial applications of radiation.” Some doses of radiation? In Oak Ridge, Tennessee, a pathologist significant achievements did come out of Oak Ridge’s clinic, at the AEC‘s clinic, Clarence Lushbaugh,-- agrecd to search including the development of a cobalt 60 (C-60) telelherapy for some of the answers NASA wanted. machine, which served as a prototype for others now used in Oak Ridge is called the “Energy cancer therapy at hospitals across the counliy. Capital ofthe World” nowadavs. It Lushbaugh was teamed with eminent hcmatologist Gould Ius& to be known as the “A

SEPT./OCT. 1981 1022219 32 .., ‘* MOTHER JONES -2._

sinnclte and competent attendant to hi. lients, but whenev- at Sloan-Kettering UP ‘ an X-ray machine to spray their patients, but the 0, Ridgers thought that radiation-

cr~~ his niedical ministrations failed, it MSLushbaugh’s turn. ~ushbaughdid the autopsies. emitting isotopes like C-60and cesium 137 (Ce-137) would Shortly after his arrival in Oak Ridge, Lushbaugh won a be more flexible than a bulky machine. NASA dontract to conduct a retrospective analysis of the Lushbaugh explains it this way: “See, with an X-ray tube, effects of radiation: a hunt for the point at which the syn- you would put the person on the floor in the fetal position, drome symptoms appear. He looked for clues in the medical with his knees drawn up, and you’d zap him from the right charts of cancer patients who had been treated with side with an X-ray machine and then you’d flip him over and , radiotherapy. By the end of 1964, Lushbaugh had compiled irradiate him from the other side.”The METBI facility was a

tailed notes on reactions in are extremely high’doses- 500-CUfflF, CESIOM- (37 an ordinary the systematic manner of a rREATMEt4r SOURCES (61 chesl X-ray is research scientist. A “pro- \A about one-tenth of a rad- spective” study was ’ but the.exposures were and needed. Oak Ridge was the are considered therapeutic ideal place for the study and in treating some cancers. Lushbaugh was the ideal But as we will see in choice to conduct it. By Dwayne Sexton’s case and care f u I 1y mo nit o r iii g p a- those of the other 8s patients during and after tients in these experiments, radiotherapy at the clinic, the massive radiation doses Lushbaugh and his associ- were not only part of a ates could be on the lookout treatment plan, but also a for syndrome symptoms way of gathering data €or and could correlate them the space progran. with the exact dose of radia- The treatment of leuke- tion received. mia patients in METE31 began as soon as the facility was operational. Gould -1 -1 Andrews directed the clh- In 1960, the Oak Ridge clinical hematology staff. L~sh- ic had begun operating a baugh monitored the can- therapy chambNer known as L cer patients for sians of the ME-fBI-the Medium-Exposure-Rate Total-Body ha- syndrome. Many aspects of the syndrome we$ already diator. Built in a special wing of the tiny clinic, METBI was known even then. The government’s handbook for the holo- I designed for experiments testing spray irradiation as a treat- caust, The Effects of Nuclear Weapom, reports that “for ment for blood cancers. It was part of the Atomic Energy doses between 200 and 1,ooO rads the probability of sumival 1 :1 Commission’s effort to use its nuclear wares to find those is good at the lower end o€the range, but poor at lhe upper t “beneficial applications of radiation.” end. The initial syniptonls are similar to those common in ! Prior to World War 11, researchers at the Memorial Sloan- radiation sickness . . . the larger the dose, the sooner will Kettering Cancer Center in New York discovered that by these symptoms develop.” I spraying a leukemia victim’s total body with X-rays, the As part of the federally fiinded Oak Ridge Associated I radiation could be used to depress the bone marrow and kill Universities-a consollium of 50 colleges and universities ! canccrous blood cells forming there. Then, during the war, throughout the South-the AEC clinic had a ready-made scientists found that injections of radiophosphorus and sever- network from which to draw patients. Doctors in the rural a1 nitrogen mustards could achieve essentially the same re- South regularly referred cancer patients to Oak Ridge. sults at only a fraction of the cost. “In essence,” said one of Among them were people suffeiing from Hodgkin’s diiease, thc AEC’s consulting physicians, “spray irradiation techni- chronic lymphocytic leukemia, chronic granulocytic Icukc- Wc’x were superseded by simpler and better techniques.” mia, polycythemia i-ubra vera, idiopathic thrombocythemia . l-ushbaugh agrees. “The hematologists began using these and lymphosarcoma cell leukemia. 11itrWn mustards,” he says, “and so they began hogging all The Oak Ridge researchers begall their study by exposing th~~Patients with leukemia. . . . Well, obviously, the patients to 50 or 100 rads at a time in the METBI chamber at

1 r;~~li~~[ficrapistsand the whole damn field of radiologists were a rate of 1.5 rads per minute. According to an internal : m’t Villg to put up with that. So they came along with a progress report written in 1970, doctors involved in the ex- +!‘[c’~ll for doing the same things as the nitrogen mustards, periments apparently never really thought these large doses i [lll~*Mfercnce being that] you don’t have to hold the guy would benefit the patients much, but since the cancer victims i dt’\$~;1f1d stick needles in him.” would probably require radiotherapy anyway, the scientists 1 \\‘hat they camc along with at Oak Ridge was METBI- at Oak Ridge hoped to obtain some of the syndrome data ;ir ~11~1;I nc\v twist in the technique of spray irradiation. Doctors NASA wanted. “It was not our plan to evaluate the long- .- ’ . ” :O,’‘CIv ol Ook Pdgc A$socmed :1 SEPT./OCT. 1981 33 JUXLh . Lf. L’l I1 tli ._.

transfelredinto four syringes and ir’-*ted into C.K? ni Mary and feel like thcy wcrc 011 wcation. Esccpt the LETUI sue’s hips and arms. chamber had no u )WS. For ~~v Sue, the injections were mere]! .I p:~ihiIirri- LETBl was really two rooiiis, onc built within the othcr. tant, but she was stoic about her discomfort. .lIiC: .Ill. hcr The outer chambcr w;is coiwctc. Insidc, a smaller, wooden pain might help Save Dwayne’s life. But her e>LY \\ cord-an umbilical specific- L‘Serum” was filtered and ally developed to study the then injected into Dwayne. vital functions of patients as The doctors had hoped they underwent these new that Mary Sue’s healthy radiation treatments. The body would build up anti- 65-foot umbilical was used bodies, which would de- to search for syndronie stroy the leukemic cells in- symptoms. jected into her. Then, the By monitoring read-outs, antibodies in her blood technicians could watch for Serum could be used to fight subtle chanscs in respira- the leukemic cells produced tion that would indicate in Dwayne’s bone marrow. nausea. The syndrol11e But by mid-November of study had advanced to tllC 1965, it was clear that this point where the doctors experiment had failed. knew a patient was about to Dwayne Sexton’s condition get sick and vomit before was worsening. the patient did. “It was a superb idea,” The patients “would ld- ays the Baltimore Cancer 1y run the whole thing,” Center’s Peter Wiernick. Lushbaugh explains. “Just “But you just cannot do by [the pntient] opening lllc those things in humans first door [to leave the clinin- thing.” Medical authorities ber], the whole thing would icontacted by Mother Jones turn off, and he’d go out agreed that it is simply unethical to inject cancer cells into a and take a leak and go back in, and sorncbody would bring CIn him his meals.” 7 heyhuiing, unless i ’ Dwayne’s case, it was drhert was Lushbaugh was successful in coming up with data that already proven, were readily available at the time. Today, helped determine how much radiation it took to induce the research into cancer therapies using antibodies is still under syndrome. But NASA still wanted 10 know whether milder way at several facilities, including the National Cancer Insti- symptoms of radiation sickness might reduce an astronaut’s tute. Yet even now, 16 years after Dwayne’s treatment, the ability to perform routinc tasks in space. experiments are conducted largely on laboratory animals and A series of strategically on human cancer cells in laboratory dishes. placed mirrors ciiabled Mary After the failure of the bone marrow transfer, the Oak Sue to watch Dwayne in the Ridge Institute doctors belatedly began treating Dwayne METBI chamber. He thumbcd a wcll-worn comic book Sexton with chemotherapy. contentedly while the machincs were turned on. Just four The Oak Ridge researchers were col- months shy of his scventh birtliday. Dwayne had become lecting syndrome data in earnest at all-too-familiar with the routine of hospital lifc. Over three that time, but the MFTBI facility had and a half ycars, he had spcnt countlcss days at the Oak its problems and limitations. In addition, the Oak Ridgers Ridge clinic. Despite the fiiilure of the bone marrow transfcr, had a new theory they wanted to test: Could thcy alleviate chemical therapies had kept his leukcmic cells in.reniission- some of the side effects of the therapy by using lower doses of until this new crisis. radntion over days or even weeks of continuous exposure? Mary Sue silently mumblcd a prayer. On Thanksgiving By 1967, the AEC had financed the construction of a Eve 196s. blood had begun trickling from Dwayne’s nostrils Swxdfacility at Oak Ridge: LETBI-thc Low-Exposure- and oozing from the back of his throat. Mary Sue could not Rille Totill-BOdy Irradiator. The difference bctwten it and stop the hemorrhaging. Thc Sextons sped thc 7O-miIe drive ME?‘B1 w;IS likc the difference between the Ritz and a from their home in Rohbins, Tenncssce. tlc:lllclE hotel. 111 fact, thc paneled LETI31 chamber was NOWshe tviitchcd anxiciusly 21s DwilYne bcgaii to fidget 011 Vcclfic:illv clc4igncd and furnished to 100:: ]{kcan ordinary thc idunlinuni bcd. Thc only hopc for prolonging his life. thc hWCl rc)o111 \\hcrC patients undergoing th.-.rhp) could relax doctors Said. \V;is to depres fhaync’s bone niarrow with a

SEPT./OCT. 198 1 35 MOTH E R JONES J range effectiveness of these relatively large individual to Talmon:-Dmad acute iymph~icjeuk~m.h,-, doses,” Andrcws, Lushbaugh and their colleagues explained Two days later Mary Sue wrote in her journal: “The in the report. ‘‘This would have required establishing a total medical staff discussed a type of treatment they would like to treatment plan with this technique, which we were not pre- try on Dwayne. It was stated it could possibly be a cure for pared to do.” him. We know there is no hope at all for Dwayne except for a The scientists wanted to “be able to add or substitute other short life for him of from six weeks or maybe up to a year and forms of treatment,” which is not surprising, in light of the a half, and he would be so sick so much of the time.” fact that the doctors virtually admitted that the METBI Mary Sue and Talmon agonized over the decision. “We exposures were riot even the best method of treating the cancer decided it was worth the risk we would have to take for a patierzfs ruitli radiation. “One should not infer from this chance at a cure €or Dwayne,” she noted in the journal. “We study,” they wrote in acandid assessment of the experiment, were reassured that the experiment was promising enough to “that we expected these individual or infrequently given take a chance with.” exposures to produce better The doctors told the Sex- clinical results . . . at pres- tons that Dyayne’s-case’ ent, we feel that some pat- was virtually 1mpe-k~S. tern of fractionated expo- fiey mentioned that there sure [small doses of radia- were vaiious possible treat- tion in several treatments] ments but pointed out that, probably offers a preferable at best, all the treatments approach for total-body might do is provide a tem- radiotherapy.” porary reprieve. The Oak What these large, single Ridge researchers then ex- exposures in the METBI plained that they were in- chamber did offer was the terested in “bone inarrow best opportunity to monitor transfers,” Mary Sue re- for the radiation sickness calls. “They said it was ex- syndrome. According to a perimental and would kill report of the experiment the leukemia cells. They . provided to NMA, at least offered that as an alterna- two patients at Oak Ridge live. We took it as a desper- received doses of 500 rads ation move for the health of prior to a treatment called our child.” “bone marrow transplantation .” 0bviously , these two 1-1 people were ideal subjects for the doctors involved in Both Dwayne’s parents the NASA study to monitor for the syndrome. signed a consent form drafted by the Oak Ridge doctors. It It was June of 1965 and the reads, in part, “We understand and agree IO a special ex- humid air was just hinting at perimental procedure designed to try to help our child who the oppressive Tennessee has acute leukemia. This will consist of reinoving bone iiiar- summer ahead when three-year-old Dwayne Sexton first row from the child, subjecting the inarrow to radiation de- took sick. The auburn-haired boy just wasn’t his usual self. signed to kill the leukemic cells and subsequently injecting First-born child of Talmon and Mary Sue Sexton, Dwayne these cells into the mother. . , there are some risks involved had his daddy’s dimpled chin, his mother’s wide, brown eyes for both mother and child. The nature of thcse has been and enough energy to keep them both busy. That summer he explained to us, and we are willing to accept them.” changed. “Dwayne just wanted to sit or lay down,” his In fact, the signing of the form by the Sextons did not really mother remembers. “He was tired, run-down.” constitute “informed consent.” Dwavne’s parents were They visited the family doctor, who diagnosed Dwayne as apparently misled into believiny that the expehmental hone anemic and prescribed liquid iron and vitamin B-12. The marrow transfer was his best and only hope Cor survi$ treatment didn’t help much. Dwayne’s normally rosy cheeks However, that treatment was clearly untried. and sevgal remained pale and waxy. Mary Sue insisted the doctor hos- better alternatives for treating acute lymphatic leukeqia pitalize him and find out what was wrong. Blood transfusions were widely known and available. According to Dr. Peter began in an attempt to counter theanemia. Finally, Mary Sue Wiernik, director of the Baltimore (Maq~land)Cancer Re- asked thc doctor point-blank: “Does Dwayne have leuke- search Center and a former official of the Nalional Cancer mia?” The Physician said no, and then suggested that maybe Institute, a therapy protocol consisting of several chemical the cauw and cure of Dwayne’s illness could be found at Oak agents was the “common treatment at that time.” Ridge. arrangements tiad already been made. Mary Sue Instead of chemotherapy, eight days after his arrival at began kccping detailed notes in a journal. Oak Ridge, Dwayne was wheeled into the clinic’s surgical On JUlY 27, Dwayne chcckcd into the Oak Ridge clinic for arena and sedated. Bone marrow was carefully estractell the first timc. A chcst X-ray was taken and bone marrow was through seventce,i punctures in his legs, hips and breastbone. firithdr:lwn from his hip for a test. M:iV Sue just happencd by The marrow was then irradiated-probably in the METBI a roQnl where one of thc doctors was confiding the bad news chamber. That aftcrnoon, the irradiated bone marrow w’

SEPT./OCT. 1981 34 1022282- -.__ MOTHER JONES J8 large cnollgh dose of radiation to kill the cancer cells growing On thc contrary, the cvidcncc indicates that patients were tllcrc. It \v;ls risky. The ;iniount of radiation would also kill not receiving “esquihitc care.“ The physicians’ judginents of other cells ;lncj effccti\*clyknock out his body‘s inmiunity to which thcrapy might be most bcncficiai to the paticnts may bacteria. D\vayne ivould have 10 be cl~sclyguarded against have been clouded by their desire tocomc up \villi “beneficial deacllg infccrion. applications of radiation’’ for the AEC and syndrome data Fro111 METBI, Dtvayne was \\heeled into the nearby for NASA. The cancer patients who qme to the clinic for LET131 cI1;lmber. which the Oak Ridge doctors were using as help became, in effect, laboratory animals. a ger1n-free isolation ward. The unibilical monitor was In aconfidentinl report. membersof the AEC review team strappctl around his waist. The doctors told h.1ar-y Sue they that viGted the clinic in 1974 expressed their uncasiness with needed to watch his vital signs carefully. They didz’t tell her the low quality of the facility and the poor patient care. They they \vere using the umbilical to collect data for their NASA characterized the nuclear medicine program as “very pedes- study. Dwayne Sexton accepted this latest radiation therapy trian’’ and gavc the clinical hematology division *‘anunfavor- able rating.” But more im- portantly, the reviewers discovered that some patients at the clinic may have had their lives jeopardized: just beneath the wooden floor of the LETBI chamber, the Oak Ridge researchers had suspended on plastic cords approximately 50 cages of laboratory mice. Leukemia patients, especially those undergoing radiotherapy like Dwajme Sexton, are virtually de- fenseless against infection. In hospitals they are carefully isolated from any source of harmful bacteria. Yet, at Oak Ridge, the clini- cians were experimenting by irradiating mice and men si m 11 It an eous1 y and thus, 1 according to the AEC re- Momlny W;IS there, It was like a fairy tale. He was such a port, exposing the patients to potentially deadly infection brave little boy.” from the animal cages hung directly below the LETBI treat- Dwayne knew intuitively his life was ending. “Don‘t cry, ment chamber. Mommy,” he told Mary Sue ;is she stroked his forehead. Twice a week, animal carctakcrs crawled between the ”I’m going to be with Jesus.” inner and outer shells of the LET131 facility to providc fresh hletlical science has its own system of food and water for the mice. They carried the dirty cages OF MICE & MEN judgingadvances in treatment and ther- “through the patient area to an elevator and down to the cage l€Ii apy. Teams of doctors with expertise in washer,” noted the AEC .review report. “This entire the particular area of research carefully consider and evalu- arrangement seems to be questionable because of the neces- ale their fellow doctors‘ projects. sity of transporting the animals, animal wastes and equip- On several occasioiis during the LETBI and METBl ex- ment through areas used by patients who frequently have . periments, inspectors from the AEC visited the Oak Ridge compromised host defense mechanisms.” In other words, clinic. Judging by the documentary records available, most of patients whose bodies arc incapable of fighting off infcction. . the so-callcd peer reviews by doctors who scrutinized the “This area,” the reviewers wrote, “would appear to be highly Facility wcre less than laudatory. One reviewer charged “the prone to severe infestations of vernijn.” directors weren’t paying enough attention to what was going Human guinea pigs are essential to every discovery de- on. There had been a previous site visit a couple of year signed to prolong life, relieve suffering or improve the quality before mine, and their report was ignored.” 1 of the human condition. Sooner or later, someone has to I Thc rcport of the review team dispatched to submit to new therapies to determine whether they are effec- March 1074 could not be ignored. They tive or useless. Doctors routinely cornb the professional jour- facilities “substondard” and recommended the nals of their various disciplincs. searching for clues of discov- shut clo\v~~or the program be moved clscwticrc. ery provided by their peers’ succcsses and failures. Bibb. now thc Encrsy Dcp;irtnient‘s dircctor The 14 years of experiments by the Oak Ridge researches O‘tk Riclgc. argues that the clinic \(.as closed 1icc;lusc “it \va provided few of those clues. Clarence Lushbaugh did pro- giving exquisite cxc to tlic ~~eoplcit was taking duce a 224-page report on the LETBI and METBI studies for I IS not providing any research result? at all.“ NASA, but he did not publish a single scientific paper on the SEPT./OCT. I98 1 1022283 36 2’/ : MOTHER jONES ! cxpcriments in any recognized j ,.rial because “we never syndrome motiva the experiments. ”It was the AEC that of I considered them to be enough scientific quality.” In his financed that.” Bibb S~I~S.“With or without the NASA rcport’s suninmy. Lushbaugh cautioned that the studies study, that program would have gone on.” Yet, Lushbaugh’s should “not be considered definitive.” In fact, the expcri- 1975 report to NASA clearly states that “the radiobiologic ment5 raised more questions than they answered. studies” were “carried out with joint AEC and NASA sup- In their confidential report, port during the years 1964 to 1974.’‘ NASA’s support was the AEC reviewers lam- financially crucial, especially in the expcrimcnts’ final years. 1 basted the researchers for According to Allen Webb, chemist at the clinic during the their work, which they labeled “dismal.” The report explicit- experiments. “In the early 1970s. Lushbaugh had to kick ‘Y ly says the METBI and LETBI programs evolved “without asses and pull strings to get enough money to keep LETI31 adequate planning, criticism or objectives.” The bone mar- running. NASA provided the monies.” row transplant experiments received especially harsh criti- Lushbaugh himself estimates that during the ten years cism. “In-view of-accepted NASA sponsored his re- therapeutic modalities, search,

I soon corrupted. “During the course of the study,” they noted Did the LETBI and METBI radiation experiments actual- in their progress report, “the urgent need arose for informa- ly benefit the patients? tion on hematologic effects in man, since the National Aero- The AEC’s reviewers answered that question with a11 nautics and Space Administration was faced with potentially unequivocal and emphatic no. “There has been little high levels of radiation exposures in space exploration.” thought,” they wrote in a disturbing assessment of the expcri- In short, the syndrome search took precedence. It is not ments. “as to therapeutic utility or potential long-range con- surprising that the METBI and LETBI experiments-with sequences.” In any medical facility, what is best for the respect to cancer therapy-would get a lower priority: Lush- patient should always be of paramourit importance; and yet. baugh and Andrews admitted in their 1970 progress report the AEC reviewers accused the Oak Ridge researchers of 1 that they did not expect “these individual or infrequently ignoring whether the therapy they employed was doing any given exposures to produce better clinical results’’ and that a good. Unfortunately, at least 69 cancer patients-includi~~g ’ ) different radiation treatment “probably offers a preferable Dwayne Sexton-passed through the LETBI and METBI approach for total-body radiotherapy.” chambers before the governmenl came to that belated con- De sp i t e t h~~~ ’ ce, Lushbaugh denies clusion and itself ordcrcd a halt to the espcriments. 1 emphatically the suggestion that the experiments were con- Gould Andrews left Ihc Oak Ridge I ductccl principally for NASA’s benefit. He claims his moni- THE MTERMATH clinic after the AECordcrcd 1hc lacil- ] toring program was simply “piggybacked” onto the LETBl Dity closcd and joined the faculty of thc md MEW1c;inccr therapy treatments. The Energy Depart- University of Maryland. Lushbaugh asserts that it was nlcnt’s William Bibb also denies that the search for the -Contiilucd on page .U I pbo’??’lPh by Howwd Rorcnbeq \ SEPT./OC-T. I98 1 (4 (4 MOTHER JONES tion exposure levels well below “safe” limits. While Lushbaugh has no expericnce in conducting cpi- demiological analyses, as in this new study, he does have experience in coming up with the sort of data the government COSTINUED E’IlOhl PACE 37 likes. In his final report to NASA on the LETBI and METBI experiments, Lushbaugh explained that bne of his objectives Andreiss who detcrmiiied which patients should be irradi- in undertaking the project was that “these unbiased clinical ated in the chambers and how big a dose they should get. observations were sorely needed to defend existing environ- Ho\vevcr, a number of those involved in the experiments mental and occupational radiation exposure constraints from reniembcred that a committee of the clinic’s staff-including attack by well-meaning, but impractical, theorists.” Lushbnugti-made the deterniinations collectively. Andrews In the past, when the government faced troubles because cannot speak for himself. He died in the summer of 1980. nuclear workers or atom bomb test victims were suing Uncle Dr. Karl Z. Morgan was the director of the Oak Ridge Sam for injuries they sustained, Lushbaugh was counted on National Laboriitory’s Health Physics Division during the to offer “expert testimony” against them. That was exactly LETBI and METBI experiments. Morgan is known what took place in U.S. District Court in Las Vegas, Neva- throughout the world as the “father of health physics,” a da, on May 16,1977. science dedicated to the prevention of radiation damage. He Seven years earlier an underground nuclear bomb test at is probably the leading figure on radiation protection in the the nearby Nevada Test Site went awry. Scientists had mis- United Stntcs and, as such, could hardly be called “antinu- calculated the power of the so-called Baneberry bomb, and a clear.” Curiently a professor of physics at the Georgia Insti- mushroom cloud broke through the earth’s crust and rose tute of Technology. Morgan believes that during his tenure some 10,OOO feet into the sky. The cloud began drifting at the Oak Ridge national laboratory, he was sadly confused toward an AEC base camp. Setting aside their own safety, 13 about the purpose and results of the LETBI and METBI guards frantically evacuated the camp. Three of the 13 later radiation experiments. died of leukemia, apparently because of their exposure to “I naively thought that the purpose of this nearby center unsafe amounts of radiation. Two of the widows sued the [the clinic] was to use ionizing radiation in the treatment of federal government. Clarence Lushbaugh testified against cancer in a manner that had been proven to offer justifiable one of the women. hope of remission and, in some cases. a cure.’’ Morgan says Lushbaugh now denies he had any significant role in the today. “I believe I was misled. and my hope and trust in this actual operation of METBI :ind LETI31. Yet, to prove his progr;m wcrc b:idly misplaced.” own expertise on radiation cffccts during his tc\timony at the As it till ns out, onc of Morgan’s lifetime friends, his child- Baneberry widow’s trial, Lushbaugh described thc LEJ’J3I hood Sunday school tcilchcr. was onc of the 89 patients who and METBI experiments. Hc te4tilicd that “we ourwlvc\ went to the Oak Ridge clinic for help and became a subject exposed persons to variom total-hody close\ ofriidiation, and for thc radiiition 4yndrome study. Information about the this was an ongoing study that I workcd in iinrl whcqticntly I naturc of this clinic ha\, for Morgan, ii special pain. became the leader of it, iind wc r:ldiiitcd pcr\on\ with v;iriou\ “The evidcncc strongly suggests,” Morgan continues care- kinds of leukemias in a specidly dc4gncci rooin whcrc they fully, “that the purpose of this program \viis not what we were actually lived in a sea of radiation with thcir daily daw." led to believe.” Though klorgan trained dozens of medical Dwayne Sexton died at the Oak Ridge clinic on I>cccnihy doctors himself in methods of using radiation for human 29, 1968, a month after his lii\t therapy \c\sion in MEI‘I3I. A benefit, he says he is “appiilled, overcome with consternation limited autopsy was performed. The caux of dcath W;I\ and filled with a deep sense of indignation” by the news that determined to be acute strep and staph infection. the cancer patients treated at the Oak Ridpe clinic really Ifseenn we otrly mks yorc more became guinea pins for the space program. “It causes one to As each pmsing day goes by wonder,“ Morgan concludes. “whether t& members of the Yes, our hearts have all beeri broketi medical profession who were responsible could have been Yet we hard nor to cry sincere the day they took the Hippocratic oath.” fry Clarence Lushbaugh still has his offices at the clinic itself, You were such a bright spof iii our lives but now he is the director of the Oak Ridge Associated Sirice thefirst day yorc came Universities’ Medical and Health Sciences Division and There’s an empty place it1 OIIY home brags that “only God can retire me.” Just months after the That will never be the same review team concluded it5 damaging report on the clinic, -from a poem dedicated to Dwayne, by Mary Sue Lushbaugh was awarded another ongoing contract, this one Sexton, written three months after his death . by the Energy Department to conduct an epidemiological In the entire history of the United States Manned analysis of possible health risks to nuclear workers at the Spaceflight Program, not a single astronaut ever received a Energy Department’s Oak Ridge plants. high-enough dose of radiation to sulfcr from the syndrome. Lushbaugh’s new research project could be another poten- Dwayne Sexton did. tiill bombshell if it confirms the results of a previous study of nuclciir workers. That study, by University of Pittsburgh Howard L. Rosetiberg is the nufhor of Atomic Soldiers professor Thomas Mancuso. revealed-after 12 years of (Beacoti Press, 19SO). He also describes hit?r(;e!fas“a writer work-that nuclear workers itt the Energy Department’s and rider” oti the stajf of Jack Atidersoii’s “Wrrrhbigroti Mer-

I-filnford. iV:isliington, atomic works suffered a significant ry-Go-Roirnd. ” Sicpplenietrrary research for thk article \vas increase in the incidence of certain types of cancer at radia- corifributed by flie Etrviroritnerital Policy Ceiifer.

SEPT./OCT. 198 I 1022285 44 ._ E ASSISTANT TO MANAGER FOR PUBLIC INFORMATION MANAGER'S STAFF MEETING REPORT August 24, 1981

1. By Friday afternoon news media interest had perceptably decreased on the Mother Jones magazine article concerning irradiation of patients at the former AEC/ORINS Hospital in Oak Ridge. Following a vigorous promotion effort by the magazine (reportedly with the assistance of a pub1 ic relations firm), Washington based media began coverage of the event on Wednesday prior to the Mother Jones press conference in Washington on Thursday. Regional and local news media interest increased to such an extent on Wednesday afternoon and Thursday morning that we arranged a local news conference late Thursday morning. Coverage by national media has varied but has generally tilted toward high1 ighting the accusations. Regional/local media

has been far more balanced and fair. The subject should stay on , the back burner until Congressional hearings are held in September.

2. Senator Howard Metze visitp&CEP on August 29 f briefing and tou 'lant while in t a "fund raiser" the visit. DOE of the visit.

. Arrangements e for her to vi 28. The Office

102228b STATEMENT USED BY NASA IN ANSWER TO INQUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000" funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to satisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8/20/81

1022281 STATEMENT USED BY NASA IN ANSWER TO INQUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000* funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to satisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8/20/81

1022288 STATEMENT USED BY NASA IN ANSWER TO INQUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000* funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to satisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8120181 Vol. 2/No. 12 ressSeptember 1981 ORAU United Way Campaign ‘Kicks Off’ This Month ORAU and DOE Set ORAU’s United Way drive team is off and runningP toward three major goals for the Record Straight on 1981-82 fund drive. Magazine’s Charges 0 To strive for 100 percent participation throughout all of ORAU’s divisions and offices 0 To raise at least $11,500 and work further toward a greater goal of $14,000 0 To make all ORAU employees more aware of the United Wav and whv it de- serves our help and support. Heading ORAU’s campaign is John Haffey (OIS), a former Anderson County United Way board president, drive chairman, and current board member. “Major keys to a successful drive are communication and commitment,” he says. “The more our people know about how the United Way helps our community- the young, the aging, those with special needs-the higher our chances of doing a good job.” Other ORAU drive leaders are equally enthusiastic. In fact, Executive Director Philip Johnson asked that only those Lushbaugh and Bibb speaking at press volunteers who strongly support the conference at EED conference room. United Way be appointed to represent each division, office, and program. Or. C. C. Lushbaugh, chairman of Leaders named to date include: Carole MHSD, and Dr. William Bibb, DOEScon- Byrd and Bobbie Schwarz, CARL; Joyce tract administrator for ORAU, responded Cagle, Sandra Plant, and Diane Reed, quickly in a press conference August 20 01s; Rac Cox, MERT; Carla Green, OPS; to refute claims printed in Mother Jones “IMPORTANT FOR ALL OF US.” Beth Jenkerson, OTS; Vivian Joyce, IEA; magazine that cancer patients in ORAU’s ORAU Executive Director Philip L. Marvin Peyton, EED; Phyllis Reed, OFMS; former medical clinic were subjected to Johnson asks ail ORAU employees to Bill Roach, OSH; Don Robie, MHSD, and massive amounts of radiation for the make a special effort to support the Gene Spejewski, UNISOR. purpose of gathering data for the National United Way. The services provided are Campaign plans call for a kickoff in Aeronautics and Space Administration “Important to all of us,” he said. “That’s mid-September with special programs (NASA). why ORAU strongly supports this being scheduled in each division and unit The magazine specifically cites the unique, once-a-year fund-raising ef- thereafter. case of Dwayne Sexton, a child with fort among our employees. We know of The minimal goal has been set at $1 1,500, terminal leukemia when referred to ORAU’s no better way to help those in need in a about 8 percent more than last year’s total medical clinic in July 1965. He died in more efficient way.” for ORAU and a percentage in line with December 1968 after various treatments continued, page 2 continued, page 4

After 31 Years, Museum Transfers to New Contractor, Science Applications, Inc. More than four million visitors have learned about energy at the American Museum of Science & Energy during the 31 years that ORAU has operated the Museum for the Department of Energy. After September 30, a new contractor, Science Applications, Inc. will be operating the Museum. Dr. Philip L. Johnson, ORAU’s executive director, offered “congratulations to Science Applications, Inc., best wishes to ORAU’s transferring employees who will work for the new contractor, and a pledge to help as much as possible during the transition. . .These have been good years for our organization, our employees, and our community; and we are pleased to have had a part in it all.” Three longtime employees of the Museum Division are among those who will be making the transition. Tallie Holt, maintenance mechanic, joined ORAU (then Oak Ridge Institute of Nuclear Studies) in September 1955. “I think you’d have to hunt a long time to find an organization as good as this one,” says Tallie.” Phil Lamm, a senior exhibits manager, started to work for ORAU in July 1957 with the traveling exhibits program. ”I’ve seen a lot of changes like the transition from This Museum veterans with a total of 72 Atomic World to large circulating exhibits and from strictly nuclear to all types of energy. years of service to ORAU-from left are continued, page 4 Tallie Holt, Marion Marsee, and Phli Lamm. 1022290 Thanks to you .. . it works. ,. for ALL OF US.. .Thanks to YOU.. .it works.. .for ALL OF US.. .Thanks to you.. .it works.. .for ALL OF US

IC .c . UW Campaignkickoff . mw 1’ 981-82 ‘-1s. Anderson County, for example, is working toward , an overall increase of about 8 percent. average:’ ”But we want to be better than ” drive leaders report. Thus, team leaders have set additional objectives of getting as close to $14,000 overall and to 100 percent participation a$ possible. The two goals-oneessential, and the other the “quest”-are not the only unusual parts of this year‘s campaign. “You won’t hear many of us talking about a fair share, for example,” John said. “The individual is the only one who knows what’s fair. For some, $50 may be far more generous than $100 for another. We do hope everyonegives according to ability. But our real objective is to corn- Eager to get the UnMed Way campnign $tatted,Carla Green, left, and Beth Jenkawson, municate the need, and then we know right, sign pledge cards as others on the United Way team watch. From left, are Sandra our fellow employees will respond.” Plant, Joyce Cagle, John Haffey, Marvin Peyton, Bobbie Schwa- and Diane Reed.

Walburg Is New Director of Marmoset Program DOE To Extend Contract Or. H. E. (Pete) Walburg is the new The Department of Energy has an- director of the marmoset research and nounced it would extend its contract with breeding program which will be reporting ORAU to conduct a broad range of energy- directly to the Execu- related research, education, and training tive Office. He is also programs for an additional five-year director of CARL period. which will become R. J. Hart, manager of DOESOak Ridge part of ORAU Octo- Operations, said negotiation of terms and ber 1. conditions between DOE and ORAU would The marmoset begin shortly to extend the current con- breeding program tract through September 30, 1987. The began in 1961 with a present contract expires June 30, 1982. colony of wild mar- ORAU’s operating budget for FY 1981 is mosets and tamarins. Walburg estimated at about $21 million, with $15 Currently, the inventory is about 450 million from DOE as the largest funding marmosets, comprised mostly of cotton- source. The balance comes from grants topped and white-lipped tamarins and the and contracts from other federal agencies common marmoset. “Reproduction in the such as the National Institutes of Health, ORAU marmoset colony has improved the Environmental Protection Agency, steadily since its inception due largely to the Nuclear Regulatory Commission, and the effort of Drs. Nazareth Gengozian and private sources. Conrad Richter working with MHSD staff ,” he said. Why is the marmoset program important? Pete explains, “Marmosets are IEA Has New Home Fred Snyder Teaches becoming increasingly important as At UTM and UNC models for human metabolism and dis- in Washington D.C. ease, not only because they are phylo- The IEA Washington office now has Fred Snyder, MHSD assistant director, genetically related to man as primates, a new address. Actually it has just has been reappointed a professor in the Department of Biochemistry of the Col- but because they are able to breed in moved around to the other side of lege of Medicine at the University of captivity.” Dupont Circle. Also, he said, “The cost of marmoset “We are right on top of the Dupont Tennessee Center for Health Sciences in production and maintenance is much less Circle Metro Stop at 1346 Connecticut Memphis. than for the more commonly utilized Since 1964, Fred has been a volunteer Avenue, Suite 530,” says Sue Kincade, rhesus and other macaque monkeys. An administrative manager. faculty member and spent a few days increase in marmoset usage can be ex- The Carnegie Endowment for Inter- each quarter at the college teaching bio- pected as budgets continue to be re- national Peace Foundation which has chemistry. And several graduate students stricted .” sublet to the Washington office for the have come to ORAU and done doctoral Others on the marmoset staff are Isaiah last five years needed the space for its research under Fred. Caldwell, Robert Carson, William Arndt, own programs. IEA is now leasing from The University of North Carolina at and Roy Rice. the Dupont Circle Building. The phone Chapel Hill also shares this samearrange- number is still the same, 202-653-3290. ment with ORAU and Fred. UT and UNC IO2229 1 are both ORAU member institutions. J Thanks to you.. . it works.. .for ALL OF US.. .Thanks to you.. .itworks.. .for ALL OF US. ..Thanks to you .. .itworks .. .forALL OF US

TD’s Graduate, Head for Schools All Over United States and Puerto Rico After a tough ten-week training period, the Washington area; Fran Capaldi, Ari- Energy Adventure, a program on petro- 14 more teacher-demonstrators (TD) left zona; Mike Clayton, Ohio; John Guyton, leum, will be spread across the United with their props, speeches, and enthusiasm Mississippi; Karin Hokkanen, Michigan: States by 11 TD’s. John Bouffard will to spread the energy word across the Ken Klapp, New York; Ed McCleary, Okla- cover Kentucky; Tim Handler, New York; nation. “And believe me, they are ready,” homa, Illinois, North Carolina, and Virginia; Joe Haubenreich, Illinois; Mary Huffman, claims EED’s Marvin Peyton, director of Janet Michel, Louisiana; Jim Noey, Ohio: Michigan; Don Kilgore, Colorado; Kevin training . Kan O’Keefe, New York; Miguel Moreland Mart, Washington; Ty McKinnie, California; EED took a new approach to training Myriam Perez, Puerto Rico; Jim Pucketr, Cathy Price, Ohio; Chris Salmon, Georgia; TD’s this summer with more emphasis on New Jersey; Joe Sprigg, Alabama; Paul Rita Schalk, Louisiana; and Jack Valentine, academics. “In the past we’ve presented a Viggiano, Florida; and Sue Wood, Texas. New York. summary of the basics,” explains Marvin. Jim Anderson and Chuck Spets will “This year, the TD’s received agood, solid rove the United States with the Breeder foundation with an intensive review of Reactor Corporation’s program, Energy physics, chemistry, biology, and geology. for the Future. We were not trying to make TD’s energy experts, just good teachers and resource persons.” Ladies Night Out During training, TD’s were expected to learn three training manuals from cover- Where: Ridge Inn Restaurant to-cover, write their own script for their Date: September 17, 1981 traveling programs, and maintain their Time: 5:30 p.m. equipment and van. Each TD also pre- Price: $6.00 sented programs in the Museum audi- (includes tax and tip) Deadline for torium for daily visitors. “The cooperation with other divisions Reservations: September 14, 1981 during the TD training is tremendous,” says Marvin. “Also several on the EED Please contact Dale Jones at 576-3034. staff gave presentations in their fields and it’s a great way for the TD’s to learn.” The team of 31 TD’s consists of 14 new ORNL Physicists Hear members and 17 who returned from last Summer Researcher year. TD’s are sponsored either by ORAU, a public utility, or a university and are Mary Ann Heck, a student research assigned to a particular area. Four TD’s participant at UNISOR, made a presenta- will be taking out EED’s newest traveling tion on developing rare-earth oxide targets program, Gas Works, the story of natural Before headlng out in five different and catchers for ion sources to ORNL’s gas. They are Dean Keith, assigned to dlrectlons, TD’s Sue Stone (Standing left), Physics Division last month. She is work- New York; Jim Sexton, Indiana; Sue Stone, Dave Warner (kneeling left), Don Kllgore ing on this experiment with UNISOR’s northwest United States; and Dave Warner, (seated left), Jim Sexton (kneeling right), Ron Mlekodaj. Connecticut. and Paul Vlggiano (standing right) pose A chemistry major at Clarke College in Fifteen TD’s are assigned to Energy with Daphne, the eight-and-a-half-foot Dubuque, Iowa, Mary Ann was inadvert- Today and Tomorrow, a program on all inflatable dinosaur, a major prop in the antly left out of last month’s Express forms of energy. Donald Baker will cover Gas Works program. article on the summer researchers. 4

ORAU and DOE Set Recorh Straight on Charges 1~~ Memoriam contlnued from page 1 ORINS Staffer Dies including chemotherapy and whole-body cords. NASA work did not affect the irradiation. treatment protocol. Nizabeth Rona, a pioneer in the field of Dr. Lushbaugh told Oak Ridge-Knoxville Patients had excellent care. In fact, radioisotope techniques, died July 27. area news media that ”The primary focus part of the limits on the research She was an esteemed member of the of the program at the medical clinic was value was because care of patients scientific staff of the the beneficial application of nuclear med- came first. . .” former Oak Ridge icine in the treatment of cancer. The Albert Gore, Jr. U.S. Representative of Institute of Nuclear patient’s needs always came first.” Data Tennessee’s Fourth District, has stated a Studies (now ORAU) analysis of existing patient records for Congressional hearing may be held in from 1950 until her NASA had nothing to do with the medical September. retirement in 1965. decisions, he said. Following her sec- Dr. Lushbaugh said that the Sexton boy ond retirement from was given the best possible care. “His New Contractor for Museum the University of Mi- ami’s Institute of Ma- parents brought him to the hospital be- continued from page 1 Rona cause his own doctor had done every- rine Sciences, she But, I sure have enjoyed it,” adds Phil, returned to Oak Ridge and wrote a short thing that could bedone.. .We treated him “otherwise I wouldn’t have been here so and kept him alive for three years.” The history of radioactivity, nuclear physics, long.” average lifespan for such victims was and atomic energy from the vantage point Marion Marsee, also a senior exhibits of having known and worked with the about a year at that time with virtually 100 manager, joined ORAU in July i959. “It‘s percent mortality. Today the lives of about great pioneers of nuclear science. “How It a great opportunity to travel and meet Came About” was published by ORAU in half can be saved. people,” says Marion. “I haven’t gotten On August 21, after completing a review 1978. into any humdrum at the Museum. It’s all Roger Cloutier, program director of of the records on the care and treatment been challenging and exciting.” of the Sexton youngster, Dr. Bibb said Professional Training and a long-time that the records indicate that Dwayne admirer of Or. Rona, pointed out that she Sexton was not involved in the NASA will be remembered for her research in geochronology of ocean sediments and study at all. In fact, the primary report to ORAU Employees’ Club NASA on high-level radiation was pub- for her teaching skills. “For over sixty lished the year before the Sexton boy West Side Dinner Theater years she taught other scientists how to died. ”Oklahoma” measure radioactivity. Although she felt In a letter dated August 25 to the ORAU October 15, 1981 her students’ work was always more im- board and the biomedical advisory com- $10 Per Couple - Club Members portant than her own, none have yet mittee, ORAU’s Executive Director Dr. $12 Per Couple - Museum Employees matched her contribution to science,” he Philip L. Johnson pointed out a number of $17 Additional Guests said. factual inaccuracies in the Mother Jones A native of Hungary, Elizabeth Rona article. received her Ph.D. at the age of 21 from Said Dr. Johnson, “It is clear that: the University of Budapest around 1912. Consent forms indicating the na- Already a noted scientist when she emi- ture of treatments were signed by all grated to the United States in 1941, she patients including Mrs. Sexton. became a naturalized citizen and con- The NASA study was a retrospec- tinued her distinguishedcareer for almost tive study of some 3000 patient re- 40 more years.

Oak Ridge Associated Universi?ies Post Office Box 1 17 U S. Postage Oak Ridge, Tennessee 37830 Oak Ridge, Tennessee Permit No. 80 A Nonprofit Organization iex~ressA Address Correction Requested Editor Photographer Diane Reed John Richards (615) 576-3147 (615) 576-31 59

The Express is a monthly publication for ORAU employees and family members. Please call us if you have story ideas and suggestions.

1022293 Report on Congressional Hearing by llouse Science and Technology Subcommittee on Investigations and Oversight Chaired by Rep. Albert Gore, Jr. (D-Tennessee, Fourth District) Regarding the Mother Jones Controversy

In mid-August, 1981, promoters of an article scheduled for the Septcmbcr- October edition of an antinuclear publication entitled Mother Jones charged that the Oak Ridge Institute of Nuclear Studies (as ORAU was known before 1966) had used patients as ''human guinea pigs" without their consent in experiments to provide data for the National Aeronautics and Space Administration.

National television and other news media had been contacted to detail charges in the article, "Informed Consent ,'I with subheads "How Much Radiation Can An Astronaut Withstand? NASA Used Dwayne Sexton to Find Out." Specifically the article charged that ORAU's Medical Division had experimented unethical-ly to find beneficial applications of nuclear energy and help NASA without regard to the best interests of patients. As a focused example, the author Howard L. Rosenberg alleged that medical assistance to one young patient (Sexton) had been inadequate and improper (e.g., that radiation levels were too high). Rosenberg also claimed that clinical facilities were substandard and produced little of research value. As a result of the charges, Congressman Albert Gore, 3r. (&Tennessee, Fourth District) scheduled hearings subsequently held Scpt- ember 23 in Washington before the House Science and Technology Subcommittee on Investigations and Oversight.

The response of U.S. Department of Energy and Oak Ridge Associated Univcr- sitics officials was prompt and effective:

1. On August 20, 1981, the same day that promoters of the magazine article had a Washington press conference, a DOE-ORAU press conference was held at ORAU in which DOE'S Dr. William Bibb and ORAU's Dr. C. C. Lushbaugh countered the magazine charges and outlined the true background and purposes o€ the program. The weight of the evidence was clearly against Mother .To=. Local newspaper and TV coverage was overwhelmingly supportive of OMU. Specif ically, DOE/ORAU efforts communicated:

A. Patients were never "used as human guinea pigs" in the sense conveyed by the Mother Jones article; i.e., as unknowing victims of experiments for purposes without regard to their best interests. The patients' needs always came first.

\ B. Dwayne Sexton, the child exploited in the Mother Jones article, did not receive high levels of radiation "to test man's tolerance of radiation in space," but in a last-ditch effort to save his life. Conventional chemotherapy and other treatments had failed. The child was dying after more than three years of various therapies in the ORAU hospital and clinic; his doctors concluded that the high levels of radiation were essentially the only means left to extend his life. In fact, he had lived 3.5 years after first entering our clinic with acute lymphocytic leukemia.

IO22244 C. It is true that patients did receive experimental treatments with total body irradiation and that some of the data was used as part of a retrospective study to determine levels of human radiation tolerance. However , the treatment protocols were not influenced or biased in any way to enhance these evaluations. This study also examined 3000 patient records from 45 other hospitals that used total body irradiation in leukemia therapy. Ironically, the Sexton boy's irradiation therapy actually occurred after ORAU had completed the report to NASA rind the National Academy of Sciences on high-level radiation in 1967--the year before the Sexton boy died. In 1968 the primary clinical research interest was in protracted and fractionated low-level radiation and not in single-dose exposures.

D. The child's parents were fully informed about the treatment--both verbally and in explanations written in lay language and signed by Mr. and Mrs. Sexton. The parents clearly gave ORAU their informed consent.

1;. Although some program reviewers questioned the research valiic of some of the work of the clinic and the quality of the general facllltfes, the fact is that patient requirements always came before expcrimcmtal needs for data, and good equipment was more important than high- quality buildings per se. The research clinic operated as well as possible within available government funds, making substantial con- tributions to the development of nuclear medicine over the past 30 years.

2. At the Gore subcommittee hearings, the points outlined above and many others were effectively presented by both DOE, ORAU, and former clinic employees and patients. Immediately following the hearings, Rep. Gore was quoted as saying the Mother Jones charges had been "essentially refuted." A report from the House subcommittee is expected late this fall.

A***

1022295 How Much Radiation Can An Astronaut Withstand? NASA Used Dwayne SextonTo Find Out.

BY HQ\VARD L. RQSENBERG

he dinily lit hallway weaved left and right like designed chambers at the Institute of Nuclear Studies in Oak a maze. Ciutching Dwayne's small hand, Ridge, Tennessee. Medical collfidentiality has prevellted Mary Sue Sexton fell in step behind the identification of most of these patients. Information provided white-coated technician. They passed a con- by medical personnel at the facilitjl and a telephone canvas- trol panel and waiked through a wrought- sing of one area of Tennessee led to the unfolding story of iron gate into the chamber, The room was Dwayne Sexton and how he was used to obtain data for the dark except for a brilliant halo over an emp- United States'space program. It is hoped that the publication ty, aluminum bed. of this account will spur other patients who went through Dwayne climbed over the nylon net sur- these experiments or their families to come fonvard with

1 d and settled into the trough-shaped berth. more information about the controversial 11 ealments. Mary Sue exchanged reassuring smiles and a hesitant wave Based on an 18- non nth Muher Jorzes investigatiori and 3 with her six-year-old son, Then she turned and stepped back review of thousands of pages of documents obtained undcr

Freedom of Information Act doco- nieiits and consultaliois with lending medical and scientific authoritics ieveal that these treatments evolved into somelhing quite different: oThe Oak Ridge Institute, where the treatments were conducted, was an 1 Atomic Energy Commission (AEC) clinic used for simuItaneous resca~ch ' experiments 011 animals arid hun1aus. e I Leading authoritics on radiation protection. and even rlieAECilscl/in its review of these expcrirnents, judged that the treatmcnls were of litrlc. if any, benefit to the patients. The ~ilw I

,I MOTHER JONES Today Oak Ridge’s broad, main avenues are still lined 1 with Army barracks, converted and refurbished as apart- I ment buildings. The “downtown” area is a modern shopping I center. The denizens of the “Energy Capital” are a curious mix of rural-bred hill people and scientists and technicians from around the world. One out of everj 35 Oak Ridgers holds a Ph.D. degree-one of the highest per capita ratios in the nation. Clarence Lushbaugh amved in 1963 to head the AEC clinic’s ominously titled “Applied Radiation Biology Divi- sion.” A short, balding man with a combative personality, Lushbaugh likes to say he “grew up in the gutters” of Ciiicin- nati, Ohio, wnere his name, Clarence, “was a fighting name-you had to protect a name like Clarence.” Most of his friends now call him “Lush,” but the feisty attitude of his youth has not mellowed much in 65 years. The nameplate behind Lushbaugh’s desk infomls visitors that he is the HSOBIC-Head-Son-Of- a-Bitch-In-Charge. Educated at the Univer- sity ol Chicago, wliere he received his bachelor’s degree, a Pl1.D. in pathology and an M.D. in medicine, Lushbaugh began his career in 1S49 as a pathologist in Los Alamos, New Mex- ico-another “atomic city.” He doubkd as the government town’s coroner. In 1963, Lushbaugh moved to rural Tennessce and became a i member of the staff of the Oak Ridge Institute. “In Los Alamos,” he explains, “we had plenty of radioiso- i topes and plenty of machineiy, but we didn’t have a \vhole lot ! of sick people because it was a rather young population.” Oak Ridge offered the same access to radioisotopes plus a large group of Tennesseans who weie gralcful for free medical attention at the AEC clinic. The Oak Ridge Institute had a mandate froin the Atomic Energy Commission-which was then the government agency charged with promoting nuclear energy-io conduct research into the “beneficial applications of radiation.” Some significant achievements did come out of Oak Ridge’s clinic, including the dcvelopment of a cobalt 60 (C-60)teletherapy machine, which served as a prototype for others tiow used in canccr therapy at hospitnls across the country. Lushbaugh was tcanled with eminent Iicrnatologist Gotild Andrews. Lushbaugh’s star was rising. Andrews “was probably the world-renowned espert in taking carc of peisons fuel for the hkinhattan Project’s A-bombs World I*,’ar with radiation injuries,” Lushbaugh says modestly, “and I 11. Hidden in hollows amid rolling hills of black osk, massive was the world-rcnowncd expert at trying to ligule out what went wrong at the autopsy table.” Ifsomconc \vas acutely irradiated in an accident, no matter i when or where, Andrcws wascallcd in lo give inec‘icnl attention. Idis hunched figure \\’as unmistakablc-he \vas afflicted with cxtrcmc curvature of the spine. Andrcws was 3 compns-

SEPY./OCT. I98 1 \ 1022291 32 I. sion;ltc arid competent attendant to hi5 patients, but whcnev- at Sloan-Keltering L . an X-ray machine to spray their cr his Iiicdical ministrations failed, it was Lushbaugh’s turn. patients, but the Oak Ridgers thought that radiation- Lushbaugh did the autopsies. emitting isotopes like C-60 and cesium 137 (Cc-137) would Shortly after his arrival in Oak Ridge. Liishbaugh won a be more flexible than a bulky machine. NASA contract to conduct a rctrospectivc analysis of the Lushbaugh explains it this way: “Sce, with an X-ray tube, effccts of radiation: a hunt for the point at which the syn- you would put the person on the floor in the fetal position, drome symptoms appear. He looked for clues in the medical with his knees drawn up, and you’d zap him from the right charts of cancer patients who had been treated with side with an X-ray machine and then you’d Rip him over and , . radiotherapy. By the end of 1964, Lushbaugh had compiled irradiate him from the other side.”The METBI facility was a data on more than 3,009 patients at 43 different hospitals. quantum improvement. But the retrospective analysis had its limitations. The pa- The doctors could zap their patients in a specially designed tients had received varying doses of radiation, and their room with doses ranging from 1.8 rads per hour (1.8r) to 3cK) dnrtnrs had not kept de- rads per hour (ZOOr). These tailed notes on reactions in are extremely high doses- an ordinary chest n-ray is I the systematic manner of n I research scientist. A “pro- about one-tenth of a rad- spective” study was but theesposures were and needed. Oak Ridge was the are considered therapeutic ideal place for the study and Lushbaugh was the ideal choice to conduct it. By carefully monitoring patients during and after radiotherapy at the clinic, Lushbaugh and his associ- ates could be on the lookout for syndrome symptoms and could correlate them with the exact dose of radiation received. IlfiE EPI EF 1 C I At” USES?[ his is a model of rlie ASETBIJacilit-v at Oak Ridge. Here and i UlZQ&~Ierc/i~~~iber89catzcerpnlients were treated with higil levels ( In 1960, the Oak Ridge clin- radinlioti. The project apparently began as an attempt to impro) ic had begun operating a cancer tlterpy. Ultirtideb, IIW experinrents benejtcd NASA. theraov chamber known as MET’BI-the Medium-Exposure-Rate Total-Body Irra- syndrome. Many aspects of the syndrome were already 2 d diator. Built in special wing of the tiny clinic, METBI was known even then. The government’s handbook for the holo- designed for experiments testing spray irradiation as a treat- caust, The Eflecfs of Nuclenr EVcqmts, reports that “for ment for blood cancers. It was part of the Atomic Energy doses between 200 and 1,OOO rads the probability of swsival -; Commission’s effort to use its nuclear wares to find those is good at the lower end of the range, but poor at the upper I “beneficial applications of radiation.” end. The initial symptoms are similar to those comnion in Prior to World War 11, researchers at the ?demorial Sloan- radiation sickness . . . the larger the dosc, the sooner will Kettering Cancer Center in New Yorl; discovered that by these symptoms develop.” spraying a leukemia victim’s total body with X-rays, the As part of the fcdcrally funded Oak Ridge Associated jI radiation could be used to depress the bone marrow and kill Universities-a consortium SO colleges and universities of c:mcrous blood cells forming there. Then, during the war, throughout the South-the AEC clinic had a ready-made scientists found that injections of radiophosphorus and sever- network from wl!ich to draw patients. Doctors in the rural al nitrogen mustards could achieve essentially the same re- South regularly rcferrcd caiicer patients to Oak Ridge. sult\ at only a fraction of the cost. “In essence,” said one of Among them were people suffe~ingfrom Hodgkin’s diiease, thc AEC’s consulting physicians, “spray irradiation techni- chronic lymphocytic leukemia, chronic granulocytic Icukc- WC\ \\’ere superseded by simpler and better techniques,” mia, polycythemin rubra vera, idiopathic thrombocythemia I-ll\lhxq$ agrees. “The hematologists began using these arid 1yrnphosarco1n;lcell leukemia. 11itr+!cn mustards,” he says, “and so thcy began hogging all The Oak Ridge rcscarchers began their study by exposing thv paticnts with leukemia. . . . Well, obviously, the patients to 50 or 100 rads at a time in the METI31 chamber 21 r*lL(lt’ll1crapictsand the wliole darnn field of radiologists were a rate of 1.5 rads per minute. According to an internal m’f cc)iilg to put up with that. So they came along with a J progress rcport wrilteii in 1970, doctors involved in the cx- ‘!‘1~‘111 for doing the same things as the nitrogen mustards. perirnents apparently iievcr really thought tllcsc large doses Ith~’rlllfcrcricc king that] you don’t have to hold the guy would bcncfit the patients much, but sirice the cancer victims dc’\(11 tIlld stick needles in hinl,” 1 would probably require radiotherapy anyway, thc scientists rl ‘‘ Il.11 thcY cmc along with at Oak Ridge was hIETJ31- at Oak Ridge hoped to obtairl some of the syndronlc data -‘I ml’“ wwf\\’ist in technique of spray irradiation. Doctors .- . NASA wanted. ”It was no1 our plan to evalu3te the long- ’1 a“‘C’v Of Od Rndq. *>%o

,?=1.. I, MOTHER JONES range effcctivencss of thesc relatively large individual to Talmon:-Dwavnc had acute Iyn?~h~~-reuke.niia._, doses.” Anclrews, Lushbaugli and their collcagucs explained Two days later Mary Sue wrote in her journal: “The in the report. “Tllis \vou]d have required establishing a total medical staff discusscd a type of treatment they ~ouldlike to treatment plan with this tcchniquc, which we were not pre- try on Dwayne. It was stated it could possibly be a cure for pared to do.” him. We know thcrc is no hope at all for Dwayne except for a The scientists tvanted to “be able to add or substitute other short life for him of from six weeks or maybe up to a year and forms of trcatrnent,” which is not surprising, in light of the ahalf, and he would be so sick so much of the time.” fact that the doctors virtually admitted that the METBI Mary Sue and Talmon agonized ovcr the decision. “We exposures \\..ereiiote~eiz the besfrriehod of treatirig the cniicer decidcd it was worth the risk we would have to take for a pcrrierrrs wirli mdiariorr. “Onc should not infer from this chance at a cure for Dwayne,” she noted in the journal. ‘‘We study,” they ivrote in a candid assessment of the experiment, were reassured that the expeiinient was promising enough to “that wc print-ctcd these individual or infrequently given take a chance with.” -. . ._.c. exposures to produce better 1IlC UUcLUl> LUlU 1111; JLA- clinical results . . . at pres- tons that DJ_vayne’s case ent, we feel that some pat- was virtually fmpckis. tern of fractionated expo- fiey mentioned that there sure [small doses of radia- were vaiious possible treat- tion in several treatments] ments but pointed out that, probably offers a preferable at best, all the treatments approach for total-body might do is provide a tem- rad io t h crapy .” porary reprieve. The Oak What these large, single Rjdge researchers then ex- exposures in the METBI plained that they were in- chamber did offer was the terested in “bone marrow best cpportunity to monitor transfers,” Mary Sue re- for the radiation sickness calls. “l’hey said it was ex- syndrome. According to a perirneiital and would kill report of the experiment the leukemia cells. They I . provided to NASA, at least offered that as an altenia- two patients at Oak Ridge live. We took it as a desper- received doses of 503 rads ation move lor the health of I prior to a treatment called our child.” i “bone marrow transplanta- i tion.” Obviously, these two people were ideal subjects t for the doctors involved in Both Dwayne’s parents the NASA study to monitor for the syndrome. signed a consent form drafted by the Oak Ridge doctors. It It was June of 1965 and the reads, in part, “We understand and agree to a special es- ENTER, D’>/A’;E.IE SEXTO11 humid air was just hinting at perimental procedure designed to try to help our child who Dthe oppressive Tennessee has acute leukemia. This will consist of reiiioving boile iiiar- I suinmer ahead when three-year-old Dwayne Sexton first row from the child, subjccting the marrow to radiation de- took sick. The auburn-haircd boy just wasn’t his usual self. signed to kill the leukemic cells and subsequently injecting i First-born child of Talmon and Mary Sue Sexton, Dwayne these cells into the mother . . . there are solile risks involved i ! had his daddy’s dimpled chin, his mother’s widc, brown eyes for both mother and child. The nature of thcse Ins been and enough cncrgy to keep them both busy. That sunimer he explained to us, and we are willing to accept them.” i I changed. “Dwayne just wanted to sit or lay down,” his In fact, the signing of the form by the Sestons did not really I mother remembers. “He was tired, run-down.” constitute “informed consent.” Dwayne’s parents were I They visited the family doctor, who diagnosed Dwayne as apparen!Iy misled into belicvin!! that the csperimental hone / anemic and prescribed liquid iron and vitamin B-12. The marrow trander was his best and only hope lor survipl, treatment didn’t help much. Dwayne’s normally rosy cheeks However, that treatment was clearlv uiltr-icd. and sevqral 7 rcniaincd pale and waxy. Mary Sue insisted thc doctor hos- bcttcr dtcrnativcs for treatin? acute IyinlAiatic Ieukeqia pitalizc him and find out what was wrong. Blood transfusions were widely known and availablc. According to Dr. PcW began iri an attempt to couritcr the anemia. Finally, Mary Suc Wicrnik, director of the Baltiiiiorc (h1;ir)~larid)Cancer Re- I asked thc doctor point-bl‘ink: “Docs Dwayne havc lcukc- i search Center and a former official of the National Cancer I mia?” Thc physician said no, and tlicn suggcstctl that maybe Institutc, a therapy protocol consisting of several chemical the causc and curc of 13wa)w’s illricss could be found at Oak agents was the ‘‘conln~orltrcatrnciit at that (ime.” Ridge. The rirrangernents Iiad alrcady been made. Mary Sue Instead of chcniotherapy, eight days after his nil-ival 3f began keeping detailcd notes in ;I jotirnal. Oak Ridge, Dwayne \vas \vhceled into the clinic’s surgicnl On July 27, Dwaync clicckcd into thc Oak Ridgc clinic for arena and scctatcd. ~oncninrcow was carefui[y estrad the first he.A chest X-ray was takn and boric Inarrow uas through SC~~CII~CCIIpunctures in his legs, hips and brcastbof1c. withchwn from his hip for a tcst. hlary Suc just happe~icdby The marrow \vas then irradiated-probnbls in the hlE7-D: tvas bad a roml wticrc one of the doctors confidirig thc neus climber. That altrrnoon. thc irradiatcd bone marrow u2> \! ~3 T ti E K J 0 N ES

was filtered and ally developed to study thc

AI---..**.. .’.,‘:-;ootPTj -.. ;ntn n\v;lyne. I vital functions of patients as .---I---,-..+thnro no\” The doctors had hoped \“Ly u,,u-.. ..-... .-.--- _- that Mary Sue’s healthy radiation treatments. The body would build up anti- 65-foot umbilical was used bodies, which would de- to search for syndronie stroy the leukemic cells in- ’ symptoms. jected into her. .Then, the By monitoring read-outs. antibodies in her blood technicians could watch for serum could be used to fight subtle changes in respira- the leukemic cells produced t ion that wo u I d indica t e in Dwayne’s bone marrow. nausea. The syndrome But by mid-November of study had advanced to lhe 1965, it was clear that this point where the doctors experiment had failed. knew a patient was about to Dwayne Sexton’s condition get sick and vomit before was worsening. the patient did. “It was a superb idea,” The patients “would real- ays the Baltimore Cancer ly run the whole thing,” Center’s Peter Wiernick. Lushbaugh explains. “Just “But you just cannot do by [the patient] opening thc those things in humans first door [to leave the clinm- ithing.” Medical authorities I ber], the whole thing would contacted bv Mother Jones turn off. and he’d eo out agreed that it is simply unethical to inject canccr cells into a and take a leak and go back in, and somcbody wouli bring healthy humng,uniess It CIn him his meals.” \’ Dwayne‘s case, It was nomther thvwas Lushbaugh was ~ucccssfiil in coming up with data that already proven, were readily available at thc time. Today, helped detcrminc how much radiation it took to induce ihe research into cancer therapies using antibodies is still under syndrome. But NASA still walitcd io know whether mildcr way at several facilities, including the National Cancer Insti- symptoms of radiation sickricss might reduce an astronaut’s tute. Yet even now, 16 years after Dwaync’s trcatment, the ability to perform routinc tasks in SDilCC. experiments are conducted largely on laboratory animals and on human canccr cells in laboratory dishes. After the failure of thc bone marrow transfcr, the Oak IIL-IJSUCto watcli Dwayne in ttle Ridge Institute doctors bclatedly began trcating Dwayne METBI chambcr. Hc thuinbcd a ~vc[I-womcomic book Sexton with chemotherapy. contentcdly while thc m:icIiiiics wre turncd on. Just four The Oak Ridge rescarchcrs were col- months shy of his sevcnth birtliday. Dwiync had become lecting syndrome data in carncst at all-too-familiar with thc routinc of hospital Iifc. Over three that time, but the METBI facility had and a half years, he hxl spcnt countless dnys at 11ic Oak its problems and limitations. In addition, the Oak Ridy Ridge clinic. Dcspitc tlic failurc of thc bonc niarrow transfer. had a new theory they wanted to tcsl: Could they allcviate chemical thcmpics had kcpt his lctikcniic cclls in.rcniission- some of thc side effectsof the tlierapy by using lower doses of until this ncw crisis. .. radiation over days or even weeks of continuous exposure? Mary SUCsilently murnhlccl a prnycr. On TIiaiiksp\wig By 1967, the AEC had financed thc comtruction of a Evc 196s. blood had bugun trickling from Dwayne’s nostrils t sccond facility at Oak Ridgc: LETI3I-thc. Low-Expostrrc- and oozing from thc hack of his throat. h,.Iary Suc could not 1 Rate Tnt;il-Bocly Irradiator. Thc difference bctswn it arid stop thc licrnorrliaging. Thc Sextons spcd thc 70-1niIc drive

Ll h.IYl‘I31 w;is likc thc diffcrcnce bct\seen the Ilitz and a from thcir honic in Robtin\. Tcnncsscc. (1c:tk hotcl. In fnct, the p;inclcd LETDI chamber was Now SIW \\.;ltchcd ansiriusly ;IS Dwayne bcpi to fidgct 011 I !Tc~ifi~;1I\~rlcsigiicd and furnished to look like an ordin;lry thc aluminum bcd. 7lic only hopc for proloriging his liic. lhc: IS h[cl roo111 M.IICIW patients uncicrgoing th;rspy.could rclas doctors s:tict. \\‘:is to dcprc\\ Ilwaync’s boric 111arrow with 3

SEPT.IOCT. 198 1 35

-- .__ 1022300

-_ . .- .. -,

, .. .. . , ., . . . .a -:, r_ . ~ [he pillow. but he enjoyed picking through n tlood of fenseless against infection. letters and Christmns cards. In hospitals they are care- which poured in from rela- fully isolated from any tives and friends. klary Sue source of harmful bacteria. slept beside Dwayne in an Yet,at Oak Ridge, the clini- empty bcd, kecping a con- cians were experimenting stant vigil. "Dwayne didn't by irradiating mice and men care what they did to him," simultaneously and thus,

Monirny was there. It \viis like a fairy tale. He was such a port, csposirlg the patients to potentially deiidly infection

SEPT./OCT. 1951 I O223Ol 36 MOTHER JONES *.

cxperiments In any recognized journd because “we never syndrome iilotivatcd the experiments. “It \vas the AEC that ccinwlcied them to be of enough scientific quality.” In his financed that.” Bibb says. “With or without the NASA report’s summary. Lushbaugh cautioned that the studies study. that prograrn would have gone on.“ Yet. Lushbaugh’s should “not be considered dcfinitive.” In fact, the espcri- 1975 report to NASA clearly states that “the radiobiologrc nients raised more questions than they answered. studies” were “carried out with joint AEC and NASA sup- In their confidential report. port during the years 1964 to 1974.“ NASA‘s support was the AEC revie\vcrs lam- finnncially crucial. espcciatly in thc expcrimcnts’ final years. basted the researchers for Aecordirig to Allen Webb. chemist at the clinic during the their work, which they labeled “disnial.“ The report explicit- cxperiments, “In the early 1970s. Lushbaugh had to kick ly says the METBI and LETBI programs evolved “without asses and pull strings to get enough rnoncy to keep LETBl adequate planning, criticism or objectives.” The bone mar- running. NASA provided the monies.” row transplant experinlents received espccially harsh criti- Lushbaugll himself estimates that during the ten years -:-- “1.. .,:e.., nf orl-ontprl NASA sponsored his re- C..,,... -.. ..- -- therapeutic modaliGes, search, the space agency ethical questions were prokided “three or four mil- raised with respect to the lion dollars.” The records protocok employed in these available are limited to the studies,” the confidential period between 1969 and AEC report read. 1976 and account for pay- The chamber experimcnts by NASA of only ments didn‘t even result in $799,766 of the total any appreciable improve- amount. Lushbaugh’s col- rnent in radiotherapy tech- league, R.C. Ricks--who niques. “There is little ifany coauthored the report for clinically useful data on the NASA-says that wiih the METBI and LETBI pro- exception of about 55.000 grams,” one of the AEC re- he spent for bicycle ergo- viewers wrote in his con- mctry equipnient. NASA fidential report four years paid his salary and Lush- later. “LETBI has been baugh’s salary, and the rest used long enough to estab- of ”the funds were spent lisli (if I understand Dr. primarily for salaries for Lushbaugh correctly) that a people to bc at LETBI.” very low dose rate does not Clearly, the papcr trail of offer any advantage over evidence leads directly to the administration of the - the space agency. Ai7 at- dose at a higher rate in small, daily fractions.” tachment to NASA purchase ordcrs (signed biAEC officials Was the purpose of the experiments primarily to provide and authorizing funds for the projcct) notes that “thc ‘Pros- data for the space program? pective‘ Human Radiation Sensitivity studies ill be coli- In the beginning, Lushbaugh and Andrews wrote in 1970, hued and will be increased in number in both LETBI and a principal objective of the experiments “was to seek infor- METE1 as more patients appropriate to this type of therapy mation that might 1ea.d to improved radiation therapy.” are referred to us.” Without NASA money. there would not However, that noble search for the light of knowledge was have been cnough cash to continue. soon corrupted. “During the course ofthe study,” they notcd Did the LETBI and METBI radiation espcriruents actual- in their progress report, “the urgent nced nrosc for informa- ly bencfit the patients? tion on hematologic effects in man, since the National Aero- The AEC’s reviewers answered that question with an naurics and Space Administration was faced with potentially unequivocal and einpiintic no. ”Tliere has been littlc /high lcvcls of radiation cxposurcs in space exploration.” thought.” they wrote in a disturbing assessment of the cspcri- -In short, the syndromc search took precedence. It is not nients. “as to therapeutic utifity or potential long-rangc con- surprising that the MET131 and LETBI esperiinents--with sequcnccs.” In any medical facility, what is best Cor the respect to canccr therapy-would get a lower priority: Lush- paticnt should always be of paramount importance; and yet. baugh and hndrcws admitted in their 1970 progrcss rcporf the AEC reviewers accuscd thc Oak Ridge rcscarclicrs of that they did not expect “these individual or infrequently ignoring whctlier the therapy they employed \vas doing all)’ given cxposurcs to produce better clinical resulrs” and that a good. Uiifortunately, at least S9 cancer pnticnts-incluclin~ ’ 4 different radiation trcntmcnt “probably offers a preferable Dwnync Sexton-passed through the LETDI and hlETB1 ap(mac1i for tot;il-body radiothcrapy.” chainbcrs before the go\’ernriient carnc to that belated tal- i Despite tih docum- ce, L~i~Iib:iii$ denics clusion and itself ortlercd ;I hnlt to the esiic‘rir~ients. I cmphaticnlly the suggestion that the expcrirncnts were con- Gould Andrc\vs lcft rhc Oak Ridzc I ducted principal~yfor NASA’s benefit. I-~Cclnirns his rnoni- THE AFTERMATH cliriic after the AEC ordcrcd the fad- I I toring progrm \vas simply “piggybnckcti” onto thc LETBI Dity clowd and joincd thc faculty of thr: and hlETUI c;inccr thcrapy treatments. Thc Encrgy Dcpnrt- Univcrsity of hinrylnnd. Lushhaugh asserts tkit it I mcnt‘s Willi:iin Bibb also denies that thc scarch for the --Coii~iiirird on pafit .U I ! P’n’Y*.)Dh by Meward Po$enbe,a SEPT./OCT. 1981 IO22302 37 MOTHER JONES tion cxposurc lcvcls well below ”safe” limits. While Lushbaugh has no experience in conducting cpi- demiological analyses, as in this new study. he does haw experience in coming up with the sort of data thc government likcs. In his final report to NASA on the LETBI and METBI expcrirnents. Lushbaugh explained that heof his objectives Andrc\vs who detcriniiicd which patients should be irradi- in undertaking the project was that “these unbiased clinical ilted in tile chambers arid how big a dosc they should get. observations were sorely needed to defend existing cnviron- f{o\vevcr, ;I number of those involvcd in the experiments mental and occupational radiation exposure constraints from renlembered that a committee of the clinic’s staff-including attack by well-meaning, but impractical, theorists.” Lushhaqh--made the determinations collectively. Andrew In the past, when the government faced troubles because cannot speak for hiinself. He died in the summcr or IYau. nuclear workers or atom bomD test victims were suing Gncie Dr. Karl Z. Morsrtn was the director of the Oak Ridge Sam for injuries they sustained, Lushbaugh was counted on Nationill Laboratory’s Health Physics Division during the to offer “expcrt testimony” against them. That was exactly LETBI and METBI experiments. Morgan is known what took place in U.S. District Court in Las Vegas, Neva-

tliroiighout the world as the “father of health physics,” a da, on May 16,1977. :.. _. sciericc dedicated to the prevcntion of radiation damage. He Seven years earlier an underground nuclear bomb test at is probably the leading figure on radiation protection in the the nearby Nevada Test Site went awry. Scientists had mis- Uniterl Statcs and, as such. could hardly be called “antinu- calculated the power of the so-called Baneberry bomb, and a clenr.” Currently a professor of physics at the Georgib Insti- mushroom cloud broke through the earth’s crust and rose tute of Technology, Morgan believes that during his tenure mne 10,000 feet into the sky. The cloud began drifting at the Oak Ridge national laboratory, he was sadly confused toward an AEC base camp. Setting aside their own safety, 13 about the purpose and results of the LETBI and METBI guards frantically evacuated the camp. Three of the 13 later radiation experiments. died of leukemia,. apparently because of their exposure to “I naively thought that the purpose of this nearby center unsafe amounts of radiation. Two of the widows sued the (the clinic] was to use ionizing radiation in the treatment of federal government. Clarence’ Lushbaugl!.. testified against cancer in a manner tljat had been proven to offer justifiable one of the women. hope of remission and, in sonic cases. a cure.” Morgan says Lushbaugh now denies he had any significant rolc in the today. ”1 believe ? was misled. and my hope and trust in this actual operation of METBI and LET13I. Yct, to provc his progrrim wcrc badly rnisp1;iccd.” own expertise on radiation effects during his tcstiinony :it tIic As it !urns out, one of Morgan’s lifetime friends. his child- Baneberry widow’s trial, Lushhaugh dcscribccl thc IaE7‘i3I hood Sunday school tcxhcr. was onc of the 89 patients who and METBl experiments. Hc tcstilicd’(hat “WC oursclvcs wcnt to thc Oak Ridge clinic for help and became a subject exposed persons to various total-body doscs of r:icliation, and for ihc rndiation syndrome study. lnforniation about the this wasan ongoing study that ? workcd in and suhsccliicntly 1 nature of this clinic hiis. for Morgan, ii special pain. became the leader of it, and wc r:ldiittcd porsons with various ”The evidence strongly suggests.” Morg;in continues care- kinds of leukemias in a specially gcsigiicd rooin wlicrc they fully. “that thc piirposc of this program was riot what we were actually lived in a sea of radiation with thcir hiiy closc.” led to believe.” Though hiorgan trained dozens of medical Dwayne Sexton died at the Oak l{idgc clinic on Ilcccnih.cr doctors himself in methods of using radiation for Iiuman 29, 1968, a month after his last thcropy scssion in tvl~ll~l.A benefit, he says he is “app:illed. overcome with constcrnation limited autopsy was performed. Thc cilusc of death was ‘and filled with a deep scnse of indignation” by the news that dctermiried to be acute strep.. and stapli infection. the cancer patients treated at the Oak Ridge clinic really Ir seems we only miss );arc more became guinea Digs for the space program. “It causes one to ‘As eacli pnssiitg day goes by wonder,” MorgiIn concludes. “whether thz mcnibers of the ~ll medical profession who were responsible could have been Yes, our hearts liave been broken Yer ye fry hard tzor lo cry sincere the day thcy took the Hippocratic oath.” Clarence Lushbaugh still has his offices at the clinic itself. Yoti were sitclz a briglit spot iit our fives but now he is the director of the Oak Ridge Associated Sitice thefirst day you carire Universities’ Mcdical and Health Sciences Division and Tlzere’s ail empty place iit oiir home . brags that “only God can retire me.” Just months after the Tliar will never b,e tly same rcvicw team concluded its damaging report on the clinic, -from a pocni dedicated to Dwayne, by hlnry Suc Lushbrtugh was awarded another ongoing contract, this one Sexton, written three months after his death . by tiic Encrgy Dcpartmcnt to conduct an cpidemiologicnl In the entire history of the United Statcs Manncd anillpis of possible hcalth risks to nuclear workers at the Spaceflight Program, not a single astronaut evcr received ;1 Encrgy Dcp;irtmcnt’s Oak Ridge plants. high-enough dose of radiation.. to suffcr from the syndrome. Lus1ih;iugli‘s IICW research project could be another potcn- Divnyne Scxton did. tixl hl1hshcll if it confirms thc results of a previous study of nucl~rworkcrs. Tht study, by University of PjttsbLjrgh Howard L. Rosfribcrg is the author of Atomic Soldiers professor Tliornas Rlancuso. revcnlcd-nftcr 12 years of (Bcacorr Prcss, 19SO). tic also clcscrihes lrinzself as “a writer \vork-Ih;lt n1iclc;ir workers ;it thl: Energy Dcpnnn1ciit’s arid rider” 011 rlre staff of Jack Adcrsotr ‘s “\\fhdlitrgtotz Mer- I{;llif~rd.~~’ushington, atomic works suffcrcd a significant ry-Go-Round. *’ Sirppkt~ietitaryrcscarclr for dtir arlicfe was incrcasc in thc incitloncc of certain types of cancer at radia- confribirled by [he Etir~irorrrnetitalPolicy Cettter.

SEPT./OCT. 1981 44 J From: J.SHERWOOD (DOE16041 Posted: Tue 28-May-85 11:03 EDT Sys 64 Subject: DEPARTMENT F ENERGY :department of e rgy rnrs sexton in a tele[ UP1 NATIONAL Wire Acknowledgment Sent

From: NEWS Posted: Tue 28-May-85 3:44 Sys 97 To: J.SHERWOOD Subject: DEPARTMENT OF ENERGY :department of energy mrs sexton in a telei UP1 NATIONAL Wire adv 6:30 am edt Parents sue government over son's leukemia death WASHINGTON (UP11 The parents of a 6-year-old boy who died of leukemia accused the-federal government today of treating him as "a human guinea pig" by using experimental radiation on him instead of conventional chemotherapy. Lawyers for Mary Sue and Talmon Sexton of Kingsport, Tenn., said they would file a $10 million lawsuit against the federal government today charging it with "unethical andimproper" experiments that led to the death of their son, Dwayne, in 1968. The suit, to be filed in U.S. District Court for the District of Columbia, said Dwayne "was deprived of his best chance of survival" and his family suffered emotional and psychological damage because of medical care he received at an Oak Ridge, Tenn., clinit run by the Atomic Energy Commission. "As a direct and proximate result of the government's negligent and unlawful conduct, Dwayne Sexton was unwittingly treated as a human ?& guinea pig," the suit said. Dwayne was diagnosed as having acute lymphatic leukemia in July 1965 after his parents took him to the clinic on the recommendation of a family doctor. After discussion with clinic staff, the Sextons agreed to the use of an experimental radiation treatment on their son. The treatment, which court documents said never had been tried on animals, involved removing bone marrow from Dwayne's body and subjecting i it to radiation before injecting it back into him. About two weeks after the treatment, Dwayne's leukemia went into remission. But 13 weeks later, Dwayne suffered a relapse and began (.I chemotherapy. When he failed to respond, the Sextons agreed to another experimental treatment in which Dwayne's entire body was exposed to radiation for 3 I hours. I The boy died Dec. 29, 1968. The Oak Ridge clinic was one of several research facilities set up by the Atomic Energy Commission to explore medical use of radiation. The clinic was closed in the 1970s, and, since then, the AEC has been replaced by the Department of Energy. Mrs. Sexton, in a telephone interview, said she and her husband, who have three sons, did not file the suit earlier because they were unaware the government's treatment had been negligent. She said they began to question the treatment in 1981 when an investigative reporter interviewed them for a story. "We want to make sure it definitely will not happen to someone else," she said. "It'll never make up for Dwayne's death." Arthur Bryant, an attorney representing the Sextons on behalf of Trial Lawyers for Public Justice, said the case is unusual because it accuses the government of negligence in implementing its experimental medical program. "It's a lot more than a simple wrongful death suit," he said. "This was a little boy who had a chance of surviving ajd they destroyed his only chance of surviving." adv 6:30 am edt

up; C?-2r.-D5 E:;:= zzc Disposition: End of Mail.

i >

CXX F 1326.8 6-83) 2 :+ - .. :-Lis Cr United States Government Department of Energy memorandum Oak Ridge Operations

August 15, 1990 DATE:

REPLY TO M-4:Alexander ATFN OF: I NTERV I REQUEST SUBJECT CBS EW

M. J. Jameson, PA-1, Press Secretary, DOE/Headquarters TO:

This is a follow-up to my Weekly Report on Friday, August 10, regarding the CBS-TV request to interview Dr. Clarence Lushbaugh (part-time consultant) of Oak Ridge Associated Universities and my conversation on this matter Tuesday, August 14, with Mark Maddox.

Recapping the request, a Producer, David Turecamo with CBS News called me on Monday, August 6, indicating that he had talked with Dr. Lushbaugh and requested an interview with him on the use of the Low Energy Intensity Total Body Irradiator (LETBI) and the Medium Energy Total Body Irradiator (METBI) in Oak Ridge some years ago. The interview would be done by Harry

Reasoner for "60-Mi nutes. " Turecamo a1 so has tal ked with Jeff Sherwood and with the ORAU public affairs office on this request. Based on discussions with Turecamo to date, it appears that the interview would likely center on the allegations by a couple in the early 1980's that their son was negligently exposed to radiation in the LETBI and that the treatment was for obtaining data on radiation exposure for the U. S. space program.

The couple's charges served as the foundation for an article carried in a national magazine, Mother Jones, in the fall of 1981. The magazine called a Washington press coaference to launch the edition and heavy news media attention followed. A press conference was held in Oak Ridge at that time. In September of that year, then Congressman Albert Gore of Tennessee, Chairman of the House Science and Technology Committee, held a Washington hearing to investigate the charges. A copy of a Science magazine article on the hearing and a hearing summary prepared at the time are attached as a

1022301 brief summary of the matter. You will note the subhead of the Science article: "Hearing finds no evidence that patients were mistreated in research. . . "A number of witnesses testified at the hearings, including Lushbaugh and others from Oak Ridge. A lawsuit was subsequently filed in 1985 by the Sextons against ORAU. The courts found in favor of ORAU. The same issues were raised again in a suit filed against the U. S. Government in 1985 in a Washington court. The court dismissed the suit since the statute of limitations had expired.

Having covered the background, we have determined that: (1) Lushbaugh did not discuss the case with Turecamo during the telephone conversation requesting the interview; (2) ORAU public affairs personnel have discussed the request with Lushbaugh directly and he has indicated that he does not want to do the.interview.

I understand, through Mark Maddox, that CBS has called at least one other site requesting an interview and that the requests may be related.

Mark indicated that Headquarters may want to become re-involved in the matter and deal with CBS directly in the request to Oak Ridge and other sites.

I have additional file material on this subject, including the statements of the Oak Ridge witnesses at the Gore hearing. Those statements and the official transcript of the September 23, 1981, hearing could be used as DOE'S official position on this matter if it was decided that our response to CBS was to be a written format as opposed to someone appearing on camera.

I" /James T. Alexander ',J Assistant to Manager for Public Information

Attachments: 1. Science magazine article dated 10/23/81 2. Congressional Hearing Summary cc's: Mark Maddox Jeff Sherwood b. **undthe Industria' Revolution man was LDC's hare a wide variety of indigenous over. he sees far too little evidence of lwgp[y confined to the fertiie site. -the crops. These are not as productive concern in influential politicat quarters. eaj-th." These sites, which provic-,, the hybrids under present conditions, bul The possibility of change in that re- plants and animals which remain his ma- may be advantageous for some LDC's to spect may be read into the scheduling of turn to ago-forestry, for example. plant- a U.S. Strategy Conference on Biologi- ing fast-growing trees for fuel in rotation cal Diversity in Washington on 16 to 18 with food plants. Multiple cropping of Xovember sponsored by the State De- unsuited to the several crops in the same field may be partment and AID. The agenda calls for new lands. Theqfragiie ecosystems of the answer to higher production in other -a discussion of "crop and noncrop plants, trees, domesticated and wild ani- these primarily trbpical lands are being places. ,/ " rapidly destroyed, lhng no time for The point, says Ashton, is tha&atotal- mals, microbial organisms, ecosystems, the economic potential ii,indigenous ly different attitude toward-&riculture aquatic resources and genetic engineer- plants to be evaluated and dc&)oyd. should be encouraged,. suggesting that ing applications." About 100 resource If a lack of funds hampers c0nse-m- the small-is-beautiful approach to alter- managers and technical experts from the . . --I tion of germplasm resources, a lag in hhve technalogy__ advocated by Ernst United States are being invited along policy is also deplored by some. Ashton Schumac_berhas much to commend it. with some foreign participants. The aim notes that the economics of world agri- Ashton 'concedes that the problem is is to consider steps the United States culture are not static. The era of cheap "many faceted'&, therefore, difficult might take to preserve biological diversi-

energy, fertilizes, and pesticides from. j.' to get across." More organizations are ty throughout the world. Since the strat- petroleum is ending. Current methods of showing interest-USDA and..AID, for egy session is the first such conference farming reky on large inputs of fenilizer example, as well as nongovehitai convened by the Reagan Administration. and water and little human lab& to raise organizations such as the World Wildl&i---..$k considered a boost for biological a narrow range of crops. Population Fund and International Union for the divtalty. growth. a shortage of arable land, and Conservation of Nature, says Ashton. rising oil prices make it advisable to But "there is a lack of communication. consider different approaches. Many Nobody is running the show." More- ness is fast disappearing.-JoHN WALSH I ATACHMENT 1 Gore Investigates Radiation Clinic

Hearing finds no evidence that patients were mistreated in research on space hazards

Congress recently looked into some died there in 1969 at the age of 6Yz. Early research, which ran from 1964 to 1974, well-publicized charges that caocer pa- press accounts suggested that Sexton had been thrown out in the course of tients at a hospital in Tcnnessec were was needlessly given radiotherapy as routine housecleaning. Gould Andrews, given nontherapeutic doses of radiation part of a prograrn to collect data for the INS' chief medical investigator, whose to produce data for the space program. National Aeronautics and Space Admin- testimony would have been valuable. The results were mixed. While the find- istration (NASA). The evidence did not died last year. ings raised questions about the quality of support this allegation. Indeed, the hear- The INS clinic was closed io 1974 after carc at the clinic, tbey did not substanti- ing produced little new information on a review committee decided that it would ate the charges of misconduct, which the NASA-sponsored research. cost too much to bring the facilities into had received national attention in August Witnesses did raise questions about compliance with the health and cleanli- (Science, 4 September. p. 1093). the quality of cafe Sexton received. how- ness standards enforced at that time by The hearing was held on 23 September ever. One physician said that it may have the big insurance companies. The staE before the House science and technology been wrong to involve the child in an and facilities were incorporated into the subcommittee on investigations, chaired immunologic experiment at INS before Oak Ridge Associated Universities. by Representative Albert Gore, Jr. (11- he had been given a standard course of As the hearings revealed. INS had Tern.). Gore picked his way carefully chemotherapy. Gore questioned some of several goals, which at times may have through the evidence, laying out a record the former INS researchers about the been in conflict. First, the clinic sought that essentially faults the clinic for oper- wisdom of conducting experiments in to help cancer patients by giving them a ating at less than the highest medical which people were exposed to radiation variety of treatments, including chemo- standards in the 1960's and 1970's. but at low dose rates for prolonged periods. therapy, which one INS staf€er referred - fails to support the charge that patients But medical witnesses said the cxperi- to as a "competitor" with the clinic's a were used in a callous fashion to gener- rnents seemed reasonably well run, given specialty: radiotherapy. A second goal P4 ate data on space hazards. the state of knowledge about radiothera- was to develop new techniques for treat- rv Much of the testimony focused on the py in the late 1960's. ing cancer with radiation. Third, some of w case of Dwayne Sexton, a child with The inquiry was limited because there the researchers were being paid by c3 acute leukemia who was treated at the were many gaps in the record. Andrew NASA to collect information on the ef- -0 Institute of Nuclear Studies (INS) in Oak Stofan. a NASA official. disclosed that fects of small doses of radiation on man. Ridge, Tennessee, from 1% to 1969. He all of NASA's documents on the INS NASA wanted to know. for example, SCIENCE. VOL. 214. 23 OCTOBER 1981 W36-8075/81i1023~2350~.0010Copyrigh~ 0 1981 AAAS 423 d whether the -adi3tion cmtted by sols consent forms used did nor eet the flares wou!d fasue or si; astronauts highest standards. in space. The Sexton case did not cast light on The findainental questions Gore the controversy involving low-level radi- Arms Control Teach-ins asked -ere: Did the Institute's desire to ation studies of interest to NASA. Sex- collect experimental data atfect choices ton, after all, was exposed to a high level lanned by Scientists of therapy, and did the therapy harm the of radiation. Oficials who were at INS patients? The hearing demonsvated that argue that the Sexton case would not some of the research was closely coordi- have been included in NASA's data bank pie meeting to learn abou: it ( nated with the effort to collect data for under any circumstances, because NASA. It did not show that patients NASA was interested only in adults. gathering to hear revivalist preac were harmed or deprived of good medi- Nevertheless. Gore did produce evi- 04 the contrary, they wil1,'hear cal care because they participated in dence showing that INS researchers felt given by some profound materi; experiments. In fact, many were given pressure to find data for NASA. In the nudear physicists, computer s conventional therapy and benefited from example that Gore cited. the INS' medi- tists\ and electrical engineers it. Those who volunteered for experi- cal director Andrews-to his credit- Amqca's best universities. The occasion, scheduled for V ans Day, 11 November, is k called.the "Convocation on the Tt Andrews-to his credit-refused to participate of Nudear War." The prime spons the Union of Concerned Scter, in what he considered unethical experiments (UCS),:.an independent group involving prisoners in California strong ties to the M&sachusetts I: tute of Technology (MIT). The purpose of the campaign, cording a draftktaternent circuli mentation had faded to respond to stan- refused to participate in what he consid- by UCSi is toIeducate Americ dard treatment. That, at least, was how ered unethical experiments involving about ttie:"threat of nuclear weapc the system was supposed to work. prisonen in California. as had been pro- the growing pokibility of nuclear v Whether or not it did in every case is not posed with "enthusiasm" by a NASA and the urgent nWto reduce as clear. oflicial. risks. . . . If'properfy organized, thc Mary Sue Sexton, mother of Dwayne, Gore also quoted from an INS budget events will identify a group of indii told the subcommittee that she felt she report to NASA on low-dose radiation uals who might participate in L. had been "betrayed . . . lied to, and experiments planned for 1970 which help" organize future arms control misled" by the physicians at the INS said: "An active canvassing program for forts. 1: clinic. She had not felt that way at first. increasing our utilization of these facili- TO insure that the message gt she explained, but only after she learned ties has been developed. . . . We antici- beyond the confines of academe. 1 recently hma journalist that her son pate that this program will produce a UCS has ,budgeted for expenses might have lived if he had been given a greater idlux of patients than we have about W,000-and secured the hc cowof standard maintenance chemo- experienced in the last 2 years." The of som3 skilled political advisers. TI therapy. Instead, he was given a partial Same memo informed NASA that "We of -/are Cad Wagner, a fom course of chemotherapy and then an now believe we are ready to use regular- field campaign manager for Senat un~3edform of immunologic therapy. ly spaced, carefully selected, repeated EdwW'Kennedy (Mass.), and D The treatment failed. The child was then small exposures over a small period of vid Bmhell, a longtime activist in co' given "maintenance chemotherapy," many months in an effort to maintain gressipnal refom. movements. and. when all else had failed, a single more uniform control of disease. . . . We person who conceived th large dose of gamma radiation. will use therapeutic irradiation scenarios campaign is Henry Kendall, chairm Although MK. Sexton said that she derived in pan from 'space radiation of the board of UCS and a profess was not fuuy informed of the risks that profiles.' . . . These may be based either of $ysics at MIT. In January he corr she and her son were taking, she did sign on intelligent conjectures or actual expe- miyioned an in-house study of th~ a consent form that described the pro- rience measured in space . . .'* Howev- technological and political factors ir posed experiment in simple terms and er, Gore did not cite evidence showing hibiting arms controt, By June he ha noted that conventional treatment had that this desire to please NASA had any *me so concerned about the cha been freely offered as an alternative. The detrimental impact on care at the INS atic state of U.S. weapons policy tha Sextons clearly volunteered. clinic. + felt some emergency action wa: The subcommittee called on two sci- Gore said that he had called the hear- called for. Until recentb, the UCS ha: entists as independent commentators: ing to find out "whether the people in- {ocused chiefly on the Commercial nu- Roben Wiernik. director of the Balti- volved in this program were treated in pear sector. Suddenly, arms control more Cancer Research Center, and Eli the best possible way for their weifare or as been made the first priority. Ken- Glatstein. chief of the radiation oncology whether they were in any way dehuman- dall insists, however, that older PI@- branch of the National Cancer Institute. ized in the search for some other social ects will not be neglect9 as a result. Neither found any evidence in the rnate- good." Neither he nor the committee Kendall and UCS' exqcutive direc- rial produced for the hearing that patient staff has passed judgment on that ques- tor, Eric Van Loon, say they have care at the INS clinic had been altered to tion yet, but they promise to do just that been surprised by the strength of the suit NASA's needs. At the same time, in a written report now being pre- response they have received. They they said. the research protocols and pared.-ELioT MARSHALL Attachment 2

Report on Congressional Hearing by House Science and Technology Subcommittee on Investigations and Oversight Chaired by Rep. Albert Gore, Jr. (D-Tennessee, Fourth District) Regarding the Mother Jones Controversy -

In mid-August, 1981, promoters of an article scheduled for the Septcmber- October edition of an antinuclear publication entitled Mother Jones charged that the Oak Ridge Institute of Nuclear Studies (as ORAU was known before 1966) had used patients as "human guinea pigs" without their consent in experiments to provide data for the National Aeronautics and Space Administration.

National television and other news media had been contacted to detail charges in the article, "Informed Consent," with subheads "How Much Radiation Can An Astronaut Withstand? NASA Used Dwayne Sexton to Find Out." Specifically the article charged that ORAlJ's Medical Division had experimented unethically to find beneficial applications of nuclear energy and help NASA without regard to the best interests of patients. As a focused example, the author Howard L. Rosenberg alleged that medical assistance to one young patient (Sexton) had been inadequate and improper (e.g., that radiation levels were too high). Rosenberg also claimed that clinical facilities were substandard and produced little of research value. As a result of the charges, Congressman Albert Gore, Jr. (D-Tennessee, Fourth District) scheduled hearings subsequently held Sept- ember 23 in Washington before the House Science and Technology Subcommittee on Investigations and Oversight.

The response of U.S. Department of Energy and Oak Ridge Associated Univcr- sitics officials was prompt and effective:

1. On August 20, 1981, the same day that promoters of the magazine article had a Washington press conference, a DOE-ORAU press conference was held at OIULJ in which DOE'S Dr. William Bibb and ORAU's Dr. C. C. Lushbaugh countered the magazine charges and outlined the true background and purposes of the program. The weight of the evidence was clearly against Mother .To=. Local newspaper and TV coverage was overwhelmingly supportive of ORAU. Specifically, DOUORALJ efforts communicated:

\ B. Dwayne Sexton, the child exploited in the Mother Jones articLe, did not receive high levels of radiation "to test man's tolerance Or radiation in space," but in a last-ditch effort to save his llfe. Conventional chemotherapy and other treatments had failed. The child was dying after more than three years of various therapies in the ORAU hospital and clinic; his doctors concluded that the high levels of radiation were essentially the only means left to extend his life. In fact, he had lived 3.5 years after first entering our clinic with acute lymphocytic leukemia.

1022311 C. It is true that patients did receive experimental treatments with total body irradiation and that some of the data was used as part of a retrospective study to determine levels of human radiation tolerance. However, the treatment protocols were not influenced or biased in any way to enhance these evaluations. This study also examined NO0 patient records from 45 other hospitals that used total body irradiation in leukemia therapy. Ironically, the Sexton boy's irradiation therapy actually occurred after ORAU had completed the report to NASA and the National Academy of Sciences on high-level radiation in 1967--the year before the Sexton boy died. In 1968 the primary clinical research interest was in protracted and fractionated low-level radiation and not in single-dose exposures.

11. Although some program reviewers questioned the research valuc of some of the work of the clinic and the quality of thc general facilities, the fact is that patient requirements always came before expcnrirnental. needs for data, and good equipment was more important than high- quality buildings per se. The research clinic operated as well. as possible within available government funds, making substantial con- tributions to the development of nuclear medicine over the past 30 years.

**A*

1022312 I022313 United States Government Department of Energy memorandum Oak Ridge Operations

August 15, 1990 DATE:

REPLY TO M-4:Al exander AlTN OF: REQUEST SUBJECT. CBS INTERVIEW

M. J. Jameson, PA-1 , Press Secretary, DOE/Headquarters TO.

Recapping the request, a Producer, David Turecamo with CBS News called me on Monday, August 6, indicating that he had talked with Or. Lushbaugh and requested an interview with him on the use of the Low Energy Intensity Total Body Irradiator (LETBI) and the Medium Energy Total Body Irradiator (METBI) in Oak Ridge some years ago. The interview would be done by Harry Reasoner for "60-Minutes." Turecamo also has talked with Jeff Sherwood and with the ORAU public affairs office on this request. Based on discussions with Turecamo to date, it appears that the interview would likely center on the allegations by a couple in the early 1980's that their son was negligently exposed to radiation in the LETBI and that the treatment was for obtaining data on radiation exposure for the U. S. space program.

The couple's charges served as the foundation for an article carried in a national magazine, Mother Jones, in the fall of 1981. The magazine called a Washington press conference to launch the edition and heavy news media attention followed. A press conference was held in Oak Ridge at that time. In September of that year, then Congressman Albert Gore of Tennessee, Chairman of the House Science and Technology Committee, held a Washington hearing to investigate the charges. A copy of a Science magazine article on the hearing and a hearing summary prepared at the time are attached as a

1022314 brief summary of the matter. You will note the subhead of the Science article: "Hearing finds no evidence that patients were mistreated in research. . . "A number of witnesses testified at the hearings, including Lushbaugh and others from Oak Ridge. A lawsuit was subsequently filed in 1985 by the Sextons against ORAU. The courts found in favor of ORAU. The same issues were raised again in a suit filed against the U. S. Government in 1985 in a Washington court. The court dismissed the suit since the statute of limitations had expired.

Having covered the background, we have determined that: (1) Lushbaugh did not discuss the case with Turecamo during the telephone conversation requesting the interview; (2) ORAU pub1 ic affairs personnel have discussed the request with Lushbaugh directly and he has indicated that he does not want to do the.interview.

I understand, through Mark Maddox, that CBS has called at least one other site requesting an interview and that the requests may be related.

Mark indicated that Headquarters may want to become re-involved in the matter and deal with CBS directly in the request to Oak Ridge and other sites.

T. Alexander Assistant to Manager for Public Information

Attachments: 1. Science magazine article dated 10/23/81 2. Congressional Hearing Summary cc's: Mark Maddox Jeff Sherwood "until the Industrid Revolution man was LDC's have a wide variety of indigenous over. he sees far too little evipencc 01 * [xgei!: confined to the fenile sites of the crops. These are not as productive BS concern in influential politid quaners. emh." These sites. which prov. the hybrids under present conditions. L .t The possibility of change in that re plants and animals which renain his nta- may be advantageous for some LDC's to spect may be read into the scheduling o turn to ago-forestry, for example. plant- a U.S. Strategy Conference on BioIoQ ing fast-growing trees for fuel in rotation cal Diversicy in Washington on 16 to It with food plants. Multiple cropping of November sponsored by the State De unsuited to the several crops in the same field may be partmenr and AID. The agenda calls fo / new lands. Tht\frag.de ecosystems of the answer to higher production in other . a discussion of "crop and noncro' these primarily trtqiicai Iands are being places. plants, trees, domesticated and wild ani / 'I rapidly destroyed, l&uing no time for mals, microbial ecosystem \ The point, says Ashton, is thava total- organisms, the economic potential d+digenous ly daerent attitude toward--&riculture aquatic resources and genetic engineei plants to be evaluated and dehqcd. should be encouraged,. suggesting that ing applications." About 100 resourc If a lack of funds hampers con&va= , the small-is-beautlN approach to alter- managers and technical experts from th tion of germplasm resources, a lag in hdve technology advocated by Ernst United States are being invited don policy is also deplored by some. Ashton Schumachn has much to commend it. with some foreign participants. The ai1 notes that the economics of wodd agri- Asbtoxhmcedes that the problem is is to consider steps the United State culture are not static. The era of cheap ''many facetedL&, therefore. difficult might take to preserve biological divers energy, fertilizers, and pesticides from..e- to get across." More' organizations are ty throughout the world. Since the stra petroleum is ending. Current methods of showing interest-USDA ind..AID, for egy session is the first such conferenc \ farming rely on large inputs offertilizer example, as well as nongovernmental convened by the Reagan Administratio! and water and little human Lab& to raise organizations such as the World WildI&i is considered a boost for biologic a omow range of crops. Population Fund and international Union for the dikxsity. growth. a shortage of arable land, and Conservation of Nature. says Ashton. e the voices crying in tf rising oil prices make it advisable to But "there is a lack of communication. wildernessMean% ar ing that the wade consider different approaches. Many Nobody is running the show." More- ness is fast disappearing.-JoHN WAL:

AlTACHMENT 1 Gore Investigates Radiation Clinic

Hearing finds no evidence that patient were mistreated in research on space hazara

Congress recently looked into some died there in 1969 at the age of 6Y2. Early research, which ran from 1964 to 19; well-publicized charges that cancer pa- press accounts suggested that Sexton had been thrown out in the course tients at a hospital io Te~esstewere was dessly given radiotherapy as routine housecleaning. Gould Andrw given noatheragmitic doxs of xadiation part of a program to collect data for the INS chief medical investigator, whc to produce data for the space program. National Aeronautics and Space Admin- testimony would have been vaiuab neresults were mixed. wethe find- istration (NASA). The evidence did not died last year. ings raised questions about the quality of support this allegation. Indeed, the hear- The MS clinic was closed in 1974 af: care at the clinic, they did not substanti- ing produced little new information on a review committee decided that it WOL axe the charges of misconduct. which the NASA-sponsored research. cost too much to bring the facilities u had received national attention in August Witnesses did raise questions about compliance with the health and clear (Science,4 September. p. 1093). the quality of care Sexton received. how- ness standards enforced at that time The hearing was held on 23 September ever. One physician said that it may have the big insurance companies. The st before the House science and technology been wrong to involve the child in an and facilities were incorporated into t subcommittee on investigations. chaired immunologic experiment at INS before Oak Ridge Associated Universities. by Representative Albert Gore, Jr. (D- he had been given a standard course of As the hearings revealed. INS t Tern.). Gore picked his way carefully chemotherapy. Gore questioned some of several goals, which at times may hz through the evidence, laying out a record the former INS researchers about the been in conflict. Fmt, the chic sou that essentially faults the chic for oper- wisdom of conducting experiments in to help cancer patients by giving ther ating at less thaa the highest medical which people were exposed to radiation variety of treatments. including cher - standards in the 1960's and 1970's. but at low dose rates for prolonged periods. therapy, which one INS staffer refer: fails to support the charge that patients But medical witnesses said the experi- to as a "competitor" with the chi were used in a callous fashion to gener- h) ments seemed reasonably well run, given specialty: radiotherapy. A second g hs ate data on space hazards. the state of knowledge about radiothera- was to develop new techniques for trt w Much of the testimony focused on the py in the late 1960's. ing cancer with radiation. Third. somc

.II*. case of Dwayne Sexton, a child with The inquiry was limited because there the researchers were being paid acute leukemia who was mated at the were many gaps in the record. Andrew NASA to collect infomation on the Institute of Nuclear Studies (INS)in Oak Stofan, a NASA official, disclosed that fects of small doses of radiation on r Ridge, Tennessee. from 1% to 1969. He all of NASA's documents on the INS NASA wanted to know, for exam SCIENCE. VOL. 214 23 OCTOBER 1981 - - 4 whether the Fadistion emitted by solar consenr forms used did not meet the flares would fLriye or s;-l-kn astronauts higben standards. in space. The Sexton case did not cast light on The fundmental questions Gore the controversy involving low-level radi- Arms Control Teach-. asked were: Did the Institute's desire to ation studies of interest to NASA. Sex- collect experimental data aEect choices ton. after ali. was exposed to a high level ianned by Scientist$ of therapy, and did the therapy ham the of radiation. Oficials who were at INS patients? The hearing demonstrated that argue that the Sexton case would not some of the research was closely coordi- have been included in NASA's data bank ple meeting to learn aboL nated wirh the effort to collect data for under any circumstances, because qllege campuses this fall w NASA. It did not show that patients NASA was interested only in adults. gathering to hear revivalist p: were hanned or deprived of good rnedi- Nevertheless, Gore did produce evi- 04 the contrary, they wiil;h cal care because they participated in dence showing that INS researchers felt given by some profound ma experiments. In fact, many were given pressure to find data for NASA. In the nudear physicists, compute conventional therapy and benefited from example that Gore cited. the INS' medi- tists\ and electrical engine: it. Those who volunteered for experi- cal director Andrew-to his credit- Amflca's best universities. Thp occasion, scheduled f ans bay. 11 November, calleddhe "Convocation on tP. Andrews-to his credit-refused to participate of Nudear War."The prime st the Uhion of Concirned S in what he considered unethical experiments (UCS),':.an independent grc involving prisoners in California strong ties to the M,ksachusf tute of Technology' (MIT). nepurpose of the campz mrding a draftistatement SI mentation had failed to respond to stan- refused to panicipate in what he consid- by UCSi is to/educate AR dard treatment. That. at least, was how ered unethical experiments involving about thei"threat of nuclear w the system was supposed to work. prisoners in California, as had been pro- the growing pokibility of nucl Whether or not it did in every case is not posed with "enthusiasm" by a NASA and the urgerj need' to red as clear. ofFicial. risks. . . . If.property organize Mary Sue Sexton. mother of Dwayne, Gore also quoted from an INS budget events will identify a group of told the subcommittee that she felt she repon to NASA on lowdose radiation U~IS~o might participate had been "betrayed.. . lied to, and experiments planned for 1970 which help" organize future arms co misled" by the physicians at the INS said: "An active canvassing program for forts. ii chic. She had not felt that way at first. increasing our utilization of these facili- To insure that the messa! she explained, but only after she learned ties has been developed. . . . We antici- beyond the &fines of acade recently hrn a journalist that her son pate that this program will produce a UCS has ;budgeted for expel might have lived if he had becn given a greater influx of patients than we have about w,OOo.and secured ti course of standard maintenance chema- experienced in the last 2 years." The of som3 +ii~ed politica~advise therapy. Instead, he was given a panial same memo informed NASA that "We of thesejare Cad Wagner, a course of chemotherapy and then an now believe we are ready to use regular- field campaign manager for : untried form of immunologic therapy. ly spaced, carefully selected, repeated EdwadKennedy (D-Mass.), E The treatment failed. The child was then small exposures over a small period of vid Bruireil, a longtime activist given "maintenance chemotherapy," many months in an effort to maintain gressi+d reform- movements. and, when all else had failed, a single more uniform control of disease. . . . We person who conceivc large dose of gamma radiation. will use therapeutic irradiation scenarios campaign is Henry Kendall, ch Although Mn. Sexton said that she derived in part from 'space radiation of We board of UCS and a prc was not fully informed of the risks that profiles.' . . .These may be based either of 9hysus at MU. in January ht she and her son were taking, she did sign on intelligent conjectures or actual expe- miponed an inhouse study a consent form that described the pro- rience measured in space . . .** Howev- technological and political fact posed experiment in simple terms and er. Gore did not cite evidence showing hibiting arms controf, By June I noted that conventional treatment had that this desire to please NASA had any *me so concerned about th been freely offend as an alternative. The detrimental impact on care at the INS otic state of U.S. weipns polit Sextons cl&y volunteered. clinic. + felt some emergency actio The subcommittee called on two sci- Gore said that he had called the hear- &lied for. Until recentiy, the UC entists as independent commentators: ing to find out "whether the people in- {msed hiew on the mmmerc Robert Wiernik, director of the Balti- volved in this program wen treated in pear mor. Suddenli arms c more Cancer Research Center, and Eii the best possible way for their welfare or as been made the fiw priority - Glatstein, chief of the radiation oncology whether they were in any way dehuman- dall insists, however, qat olde. a branch of the National Cancer Institute. ized in the search for some other social ects will not be neglect+ as a I h;) Neither found any evidence in the mate- good." Neither he nor the committee Kendall and UCS' exqcutive h3 rial produced for the hearing that patient staf€ has passed judgment on that ques- tor, Eric Van Loon, say they w care at the INS clinic had been altered to tion yet. but they promise to do just that been surprised by the strength c suit NASA's needs. At the same time. in a written report now being pre- response they have received. 2 they said. the research protocols and pared.--E~io~MARSHALL

I Attachment 2

In mid-August, 1981, promoters of an article scheduled for the Septcmbcr- October edition of an antinuclear publication entitled Mother Jones charged that the Oak Ridge Institute of Nuclear Studies (as ORAU was known befare 1966) had used patients as "human guinea pigs" without their consent in experiments to provide data for the National Aeronautics and Space Administration.

National television and other news media had been contacted to detail charges in the article, "Informed Consent ," with subheads "How Much Radiation Can An Astronaut Withstand? NASA Used Dwayne Sexton to Find Out." Specifically the article charged that ORAU's Medical Division had experimented unethically to find beneficial applications of nuclear energy and help NASA without regard to the best interests of patients. As a focused example, the author Howard L. Rosenberg alleged that medical assistance to one young patient (Sexton) had been inadequate and improper (e.g., that radiation levels were too high). Rosenberg also claimed that clinical facilities were substandard and produced little of research value. As a result of the charges, Congressman Albert Gore, Jr. (D-Tennessee, Fourth District) scheduled hearings subsequently held Scpt- ember 23 in Washington before the House Science and Technology Subcommittee on Investigations and Oversight.

The response of U.S. Department of Energy and Oak Ridge Associated Univcr- sities officials was prompt and effective:

1. On August 20, 1981, the same day that promoters of the magazine article had a Washington press conference, a DOE-ORAU press conference was held at OIUU in which DOE'S Dr. William Bibb and ORAU's Dr. C. C. Lushhaugh countered the magazine charges and outlined the true background and purposes of the program. The weight of the evidence was clearly against Mother Jo?. Local newspaper and TV coverage was overwhelmingly supportive of OMU. Specifically, DOE/ORAU efforts communicated:

A. Patients were never ''used as human guinea pigs" in the sense conveyed by the Mother Jones article; i.e., as unknowing victims of experiments for purposes without regard to their best interests. The patients' needs always came first.

b B. Dwayne Sexton, the child exploited in the Mother Jones article, did not receive high levels of radiation "to test man's tolerance 01 radiation in space," but in a last-ditch effort to save his life. Conventional chemotherapy and other treatments had failed. The child was dying after more than three years of various therapies in the ORAU hospital and clinic; his doctors concluded that the high levels of radiation were essentially the only means left to extend his life. In fact, he had lived 3.5 years after first entering our clinic with acute lymphocytic leukemia. I C. It is true that patients did receive experimental treatments with total body irradiation and that some of the data uas used as part of a retrospective study to determine levels of human radiation tolerance. However, the treatment protocols were not influenced or biased in any way to enhance these evaluations. This study also examined 3000 patient records from 45 other hospitals that used total body irradiation in leukemia therapy. Ironically, the Sexton boy's irradiation therapy actually occurred after ORAU had completed the report to NASA and the National Academy of Sciences on high-level radiation in 1967--thc year before the Sexton boy died. In 1968 the primary clinical research interest was in protracted and fractionated low-level radiation and not in single-dose exposures.

1;. Although some program reviewers questioned the research value of some of the work of the clinic and the quality of the general facilltlcs, the fact is that patient requirements always came before cxpcrirncntal. needs for data, and good equipment was more important than high- quality buildings per se. The research clinic operated as well. as possible within available government funds, making substantial con- tributions to the development of nuclear medicine over the past 30 years.

I022319 Human Guinea. 2igs at Oak RidgL .’ Scientists respond to a report that they used cancer patients to test man’s tolerance of radiation in space

The investigations subcommittee of interviewing officials, and reading until 1969, the year after Sexton’s death. the House Committee on Science and “thousands of pages” of government The animals had a separate air supply Technology is planning to hold hearings documents. system. Cages and debris were moved later this month on a report that got a lot The 20 August press conference made through hallways where patients walked, of attention on 20 August: a charge that a splash on the national evening news. but laboratory officials say there was no during the 1960’s cancer patients at a Among those who spoke before the cam- risk of contamination because the trash small clinic linked with the Oak Ridge eras were Mary Sue Sexton, distraught was kept in airtight plastic bags. National Laboratory in Tennessee may mother of Dwayne, the 6-year-old Ten- Rosenberg released other documents, have received unnecessary doses of nessean who died at the hospital in 1968; including the summary of an unfavorable gamma rays in an experiment aimed at Karl Morgan, former chief health physi- review given the clinic by the parent learning just how much radiation astro- cist at Oak Ridge, who said he felt ‘‘sor- agency, the old Atomic Energy Commis- nauts could tolerate before becoming row and dismay” that he had once sent a sion (AEC), in 1974. According to the sick and choking in their oxygen masks. friend to the Oak Ridge clinic; and Peter AEC summary, the clinic’s facilities The hearings will be chaired by a Ten- Wiernick, a physician from the Balti- were “substandard with respect to li- nessean, Representative Albert Gore, Jr. more Cancer Center, who said that he censing and accreditation guidelines,” thought the clinic made a mistake in not the entire medical division was “essen- ~ (D). Oak Ridge officials were caught some- telling patients about the uses to be made tially isolated from the critical climate of what unprepared when the author and of the radiation research. He also academic clinical investigation,” the publisher of the report, Howard Rosen- thought the Sexton child might not have main laboratories were inadequate, and the hematology program was particularly deficient. The irradiation programs were declared to be “without adequate plan- Rosenberg claimed that the cancer program ning, criticism, or objectives.” The bone was “corrupted” by the desire to find data marrow immunology program was cited for “severe criticism” because “ethical for NASA, and that patients were given questions were raised with respect to the nontherapeutic doses of radiation. protocols employed. . . .” In addition, Rosenberg cited the fact that NASA financed some of the clinic’s berg and Mother Jones magazine, held a received normal care in that he was not equipment and paid the salaries of some press conference before network televi- given a standard course of chemotherapy researchers. He claimed that the cancer sion cameras in Washington, D.C. A before other, untested therapies were program was “corrupted” by the desire spokesman for the medical division at used. to find data for NASA, and that patients Oak Ridge, Wayne Range, essentially According to Rosenberg, doctors at were given nontherapeutic doses of radi- denied the thrust of the article, but chal- the Oak Ridge Institute of Nuclear Stud- ation. lenged few of the facts. (The hospital ies who treated Sexton between 1965 and A team led by Oak Ridge pathologist itself has been closed since 1974.) Al- 1968 “belatedly began treating Dwayne Clarence Lushbaugh, now chairman of though the National Aeronautics and Sexton with chemotherapy” only after Oak Ridge’s entire medical division, was Space Administration (NASA) did pay they tried and failed to help him with an recruited to study the nausea-inducing for some of the research, Range said, its unusual experiment in immunology. Ro- effects of radiation. Lushbaugh analyzed involvement was passive. Cancer thera- senberg also stressed that Sexton was the records of 3000 patients in 46 hospi- py given at the hospital, he claimed, was later given a large dose of total-body tals to learn about the dangers that would a standard variety for 1965, and all that radiation and sent to recover in a radia- confront the astronauts. Oak Ridge was NASA gained was an opportunity to tion chamber (not in operation) used to not the primary source of Lushbaugh’s examine some patients’ records. treat other patients. Beneath the cham- information, for it gave radiotherapy to Rosenberg’s report focused on the ber was an area where animals were no more than 186 patients. case of Dwayne Sexton, a child with kept. When the room was in use, they The man who was then chairman of acute leukemia who was treated at the were exposed to gamma rays along with Oak Ridge’s medical division and design- Oak Ridge Institute of Nuclear Studies patients. Rosen berg suggested that peo- er of the treatment protocols, Gould An- between 1965 and 1968. The author ex- ple like Sexton, highly susceptible to drews, died in 1980. Speaking in his - plained that Sexton was the only one of infection, could have been exposed to place, Lushbaugh now claims that An- 0 “at least 89 cancer patients . . . system- dangerous bacteria. Sexton did, in fact, drews made all decisions on therapy and atically exposed to large doses of radia- die of strep and staph infections, a com- was in no way influenced by NASA’s N tion between 1960 and 1974 in two spe- mon pattern for acute leukemia patients. concerns. Karl Hiibner, a member of the w cially designed chambers” whose record Oak Ridge officials insist that bacteria hematology staff, said that the therapy ~3 he was able to reconstruct. Rosenberg from animals were not a problem, since offered at Oak Ridge in the 1960’s and 0 said he had spent 18 months canvassing the chamber was the cleanest area in the early 1970’s was perfectly in keeping Tennessee for information on patients, hospital, and no animals were present with standard approaches of the day. SCIENCE, VOL. 213. 4 SEPTEMBER 1981 0036-8075/81/0903-10Y~S~~1.OO/O Copyright 0 1981 AAAS 1093 ’ Range said, “We are quite proud in Manned Spacejighr, published by the Radiotherapy, at the National Cancer our record. At a time when patients wk National Academy of Sciences in 1967. t “tituie (NCI), and at St. Jude’s HosPi- acute leukemia had a survival outlook 91 Nevertheless, he conceded that Oak tal in Memphis, Tennessee (which has a about 6 months to a year, our patients Ridge did perform some NASA-financed renowned childhood leukemia program), were surviving on the average something prospective studies with cancer patients agreed that the treatment given Sexton like 4.5 years.” The record compares between 1969 and 1974. The purpose, he sounded reasonable in its context, that of well kith those of other clinical centers ’ said, was to use the new monitoring an experimental center in the mid- in the 1960’s, Range said. system to try to find physiological sig- 1960’s. Samuel Hellman of Harvard add- William Bibb, the former AEC official nals indicating that a patient was about ed, however, that the record ‘‘doesn’t in charge of funding the program, said to become nauseous before the patient sound to me like anything that approach- that the Oak Ridge clinic was opened in sensed nausea himself. No warning sig- es conventional therapy.” Yet he said, 1950 “to take advantage of some of the nals were found. Although the research “One could make a rationale for its technology coming out of the atomic was funded by NASA, Bibb insisted that efficacy, and there are people who be- energy business before it was generally the space agency had no influence over lieve in whole-body irradiation.” Today, available.” The clinic was closed in 1974 clinical procedures. whole-body doses are given only to Pre- for two reasons: other centers nearby Hubner specifically denied the charge pare a patient for a bone marrow trans- with broader skills were giving compara- that Dwayne Sexton was given improper plant, a procedure quite different from ble medical care, and the meager re- treatment. According to the medical rec- the one tried at Oak Ridge and not in use search output from Oak Ridge no longer ords, Hubner said, the doctors first ex- then. When large doses (over 100 rads) justified the cost. Bibb said that in the tracted a sample of bone marrow from are given these days, they are nearly final years, the clinic had only about the child in July 1965. Then they immedi- always focused in small areas and spread seven patients at any given time. ately started him on a course of chemo- over many days. Bibb described NASA’s involvement therapy lasting 17 days. The chemo- Eli Glatstein, chief of the NCI’s radia- as minimal. NASA came to him in the therapy was stopped while they attempt- tion oncology branch, said, “I don’t ‘early 1960’s because it was worried ed an immunologic experiment. They think whole-body irradiation is a particu- about the possible effects of solar fares, irradiated the child’s leukemic marrow larly good treatment myself, but a lot of encounters with the Van Allen belt, and cells, injected them into his mother, and it was done in the 1960’s and 1970’s, and other radiation hazards in space. In 1964, then reinjected fluid from the mother is still done for certain types of chronic 14 years after the Oak Ridge clinic had back into the boy. The hope was that the leukemia.” opened, the AEC agreed to run a retro- mother would produce antibodies to Alvin Mauer of St. Jude’s Hospital spective study to collect the data NASA fight the leukemia. Meanwhile, the leu- said that several centers experimented wanted from its own records and from kemia was judged to be in remission, with whole-body irradiation in the other places. Later on, Bibb said, NASA probably as a result of the first dose of 1960’s, although they never produced agreed that in addition to paying the chemotherapy. For 15 weeks the child techniques considered useful now. By salaries of those doing the paper analy- received no chemotherapy. Then the dis- the mid-I960’s,he said, it was “pretty sis, it would also provide some state-of- ease reasserted itself, proving that the well recognized” that chemotherapy was the-art monitoring equipment to record immunologic experiment had failed. The the standard technique for treating child- changes in the vital signs of patients child was given chemotherapy again. hood leukemia. It was also generally undergoing whole-body irradiation at The remission-relapse-chemotherapy rou- known, he claimed, that the major sanc- Oak Ridge. Patients sometimes stayed 3 tine was repeated for five more cycles, tuary for leukemic cells which could not days in the specially designed whole- until December 1968. be reached by drug therapy was the cen- body irradiation room, a chamber sus- Then the physicians decided that the tral nervous system. By 1965 St. Jude’s pended in a concrete cell and flooded drugs were failing. On 3 December 1968, had started a program in which cherno- with gamma radiation at a level of about the child was given his first and only therapy was augmented with strong 1.6 roentgens* per hour. With the aid of radiation: a whole-body dose of 353 doses (2400 rads) of radiation to the cra- NASA’s equipment, nurses could moni- roentgens (or 265 rads) over a period of 3 nium to kill leukemic cells in the nervous tor a patient’s pulse and temperature hours and 38 minutes. The hospital rec- system. The exposures were spread over without entering the room. The data ord states: “Definite relapse from the a period of 2% weeks. The procedure were examined by the physicians and acute leukemia had occurred. . . . It was was improved in 1967 to include radia- then turned over to Lushbaugh’s staff. decided to try to induce another remis- tion of the spinal cord. From then until NASA also paid for a computer to help sion by giving total-body irradiation. . . . the mid-I970’s, Mauer claimed, this was sort through the voluminous files. The patient received 353 roentgens of the standard approach for treating acute “It would have been as stupid as exposure. . . . The patient experienced lymphocytic leukemia in children. Al- hell,” Bibb said, for NASA to try to get no adverse effects during the time of the though he would not have used Oak significant data from the Oak Ridge clin- irradiation and amazingly did not have Ridge’s techniques, Mauer said, “I don’t ic alone, because it treated only 186 any nausea nor vomiting during the time think they were necessarily out of keep- patients. Any conclusion based on data, of exposure or immediately thereafter. ing with what other people were doing at he said, “wouldn’t have been worth the The patient was then kept in as sterile an this time.” paper it was written on because there environment as possible. . . . It became Oak Ridge officials have begun to re- wouldn’t be enough data points to mean quite apparent that the leukemic process spond to questions raised by the 20 Au- a damn thing.” was still not under control.” He began to gust press conference, and Bibb said that Bibb pointed out that much of the bleed internally and developed infections he looks forward to appearing at Repre- research done for NASA was incorporat- which could not be controlled by antibi- sentative Gore’s inquiry, for he thinks ed in the book, Radiobiological Factors otics. On 29 December, a little more than the laboratory will benefit from a closer *Roentgens measure radioactive ernisslons, and rads three weeks after irradiation, he died. scrutiny of the record. rnenwre absorbed radiation. Radiologists at Harvard’s Joint Center -ELIOT MARSHALL I094 SCIENCE. VOL. 213 t022321 Disposition:

FO: J ALEXANDER (DOE524) From: J.SHERWOOD (DOE1604) Posted: Tue 28-May-85 11:03 EDT Sys 64 . Subject: DEPARTMENT OF ENERGY :department of energy mrs sexton in a telephc * UP1 NATIONAL Wire Acknowledgment Sent

From: NEWS Posted: Tue 28-May-85 3:44 Sys 97 TO: J SHERWOOD Subject: DEPARTMENT OF ENERGY :department of energy mrs sexton in a telephc * UP1 NATIONAL Wire P adv 6:30 am edt Parents sue government over son's leukemia death WASHINGTON (UPI) The parents of a 6-year-old boy who died Of leukemia accused the-federal government today of treating him as ''a human guinea pig" by using experimental radiation on him instead of conventional chemotherapy. Lawyers for Mary Sue and Talmon Sexton of Kingsport, Tenn., said they would file a $10 million --wsuit against the federal government today charging it with "unethi 1. andimproper" experiments that led to the death of their son, Dwayne, 1.. 1968. The suit, to be filed in U.S. District Court for the District of Columbia, said Dwayne "was deprived of his best chance of survival" and his family suffered emotional and psychological damage because of medical care he received at an Oak Ridge, Tenn., clini# run by the Atomic Energy Commission. "AS a direct and proximate result of the government's negligent and unlawful conduct, Dwayne Sexton was unwittingly treated as a human guinea pig," the suit said. Dwayne was diagnosed as having acute lymphatic leukemia in July 1965 after his parents took him to the clinic on the recommendation of a family doctor. After discussion with clinic staff, the Sextons agreed to the use of an experimental radiation treatment on their son. The treatment, which court documents said never had been tried on animals, involved removing bone marrow from Dwayne's body and subjecting it to radiation before injecting it back into him. About two weeks after the treatment, Dwayne's leukemia went into remission. But 13 weeks later, Dwayne suffered a relapse and began chemotherapy. When he failed to respond, the Sextons agreed to another experimental treatment in which Dwayne's entire body was exposed to radiation for 3 1 hours. The boy died Dec. 29, 1968. The Oak Ridge clinic was one of several research facilities set up - by the Atomic Energy Commission to explore medical use of radiation. The 0 clinic was closed in the 1970s, and, since then, the AEC has been replaced by the Department of Energy. Iv Mrs. Sexton, in a telephone interview, said she and her husband, w who have three sons, did not file the suit earlier because they were N unaware the government's treatment had been negligent. She said they M began to question the treatment in 1981 when an investigative reporter interviewed them for a story. "We want. to make siire it definitelv will not. hannen to someone Arthur Bryant, an attorney representing the Sextons on behalf of Trial Lawyers for Public Justice, said the case is unusual because it accuses the government f negligence in implement 3 its experimental medical program. "It's a lot more than a simple wrongful death suit,'' he said. "This was a little boy who had a chance of surviving ajd they destroyed his only chance of surviving." adv 6:30 am edt upi 05-28-85 03:43 aed Disposition: End of Mail.

1022323 '.

Report on Congressional Hearing by llouse Science and Technology Subccmmittee on Investigations and Ovc~sight Chaired by Rep. Albert Gore, Jr. (D-Tennessee, Fourth District) Regarding the Mother Jones Controversy

Tn mid-August, 1981, promoters of an article scheduled for the Scptcmbcr- October edition of an antinuclear publication entitled Mother Jones charged that the Oak Ridge Institute of Nuclear Studies (as ORAU was known before 1966) had used patients as "human guinea pigs" without their consent in experiments to provide data for the National Aeronautics and Space Administration.

National television and other news media had been contacted to detail charges in the article, "Informed Consent," with subheads "How Much Radiation Can An Astronaut Withstand? NASA Used Dwayne Sexton to Find Out." Specifically the article charged that ORAU's Medical Division had experimented unethically to find beneficial applications of nuclear energy and help NASA without regard to the best interests of patients. As a focused example, the author Howard L. Rosenberg alleged that medical assistance to one young patient (Sexton) had been inadequate and improper (e.g., that radiation levels were too high). Rosenberg also claimed that clinical facilities were substandard and produced little of research value. As a result of the charges, Congressman Albert Gore, Jr. (D-Tennessee, Fourth District) scheduled hearings subsequently held Sept- ember 23 in Washington before the House Science and Technology Subcommittee on Investigations and Oversight.

The response of U.S. Department of Energy and Oak Ridge Associated Ilnivcr- sitics officials was prompt and effective:

1. On August 20, 1981, the same day that promoters of the magazine article had a Washington press conference, a DOE-ORAU press conference was held at OIUU in which DOE'S Dr. William Bibb and ORAU's Dr. C. C. Lushhaugh countered the magazine charges and outlined the true background and purposes of the program. Tlie weight of the evidence was clearly against Mother Joncs. Local newspaper and TV coverage was overwhelmingly supportive of OMU. Sptrifically, DOE/ORAU efforts communicated:

A. Patiezts were never ''used as human guinea pigs" in the sense conveyed by the ?lother Jones article; i.e., as unknowing victims of experiments for purposes without regard to their best interests. The patients' needs Eilwavs came first.

I3. Dwayne Sexton, the child exploited in the Mother .Jones articLc, did not receive high levels of radiation "to test man's tolerancc of radiation in space," but in a last-ditch effort to save his life. Conventional chemotherapy and other treatments had failed. The cliild was dying after more than three years of various therapies in the ORAU hospital and clinic; his doctors concluded thht the high level..; of radiation were essentially the only means left to extend his life. In fact, he had lived 3.5 years after first entering our clinic with acute iymnoc?-zic leukemia. C. It is true that patients did receive experimental treatments with total body irradiation and that some of the data was used as part of a retrospective study to determine levels of human radiation tolerance. Ilowever, the treatment protocols were not influenced or biascd In my way to enhance these evaluations. "liis study also examined 3000 patient records from 45 other hospitals that used total body irradiation in leukemia therapy. Ironically, the Sexton boy's irradiation therapy actually occurred after ORAU had completed the report to NASA and the Kational Academy of Sciences on high-level radiation in 1967--tlic year before the Sexton boy died. In 1968 the primary clinical research interest was in protracted and fractionated low-level radiation and not in single-dose exposures.

D. The child's parents were fully informed about the treatment--bot1i verbally and in explanations written in lay language and signed hy Mr. and Mrs. Sexton. The parents clearly gave ORAU their informed consent.

11. Although some program reviewers questioned thc research vnluc~of some of the work of the clinic and the quality of the general facilities, the fact is that patient requirements always came before expcrimrntal needs for data, and good equipment was more important than liigli- quality buildings per se. The research clinic operated as well as possible within available government funds, making substantial con- tributions to the development of nuclear medicine over the past 30 years.

Review - Felling and Kannan

Tennessee Supreme Court Rejects Application by Sexton To Review Appeals Court Decision

The Tennessee Supreme Court has rejected an application filed by Marv & Sext~which requested that court to review

a decision of the State Court of Appeals which was favorable to ORAU in the case Sexton versus ORAU. The Supreme Court held that the application seeking its review was not fi$d within time specified in its rules. The original suit was filed in Anderson County Circuit Court in 1981 by Mary Sue Sexton, the mother of a patient who

died in ORAU's former cancer hospital of acute leukemia in 1968. That court dismissed the case saying that its filing came after the statute of limitations had run. The court rejected plaintiff's allegation that there had been fraudulent concealment by ORAL?. It affirmed its holdingwhen asked by & Sexton to reconsider them.

The plaintiffs appealed that decision to the Tennessee Court of Appeals, Eastern District. The three-judge panel reviewed the decison and affirmed the trial court's ruling in

June 1984. The plaintiffs had the right to request a review by the Tennessee Supreme Court but they filed beyond the time established by law for seeking review and the Supzeme Court eeclined to review the decision of the Court of Appeals and

102232b the Trial Court, The plaintiffs have h ,ed the Supreme Court to reconsider its holding. +m A hearing by a subcommittee of the U.S. House of

Representatives4 in September 1981LA witnesses,and-rcuJ -* w-4?%Jn. documents, reached-the--&--,* decison A - -- the Zhargengainst-ORAU had-beeR,"essentially refuted" by the

-- testimony. - - I --&*I- P-e

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OAK RIDGE ASSOCIATED U)r'TVERSITTES Oak Ridge, Tennessee

Consent to Experimental Treatment

1 .... I I allthOTiZC the performance up0 of thc fo'llosing trcatrnent: w-

(State nature of treatmcnt) . Thc rrntrtre 3nd purpose of thc treatment, possibie altcrnatire . mcthods of trcatnrnt, thc risks invclvcd, and the possibilities of complicnrions havc bscn cxplaincd to mc. I understand that this treatnrnt is not the usual treatment for ny disorder and is therefore cxpcrimental anderemains unproven by medical experience so that the consrqucnccs nay he unpredictable. / DATE: 5/& &f

KITSESS :

I h:\rc talked with ahout

thc proposcd course of tfearccnf to be givrn 42.- .... inclui!inc,a thc follo=ing:*+W*1 E,J L,q .-..-. ..__- .... 2 _...... :.:.! ..r.I ...... -.... .j _... .-- . .! . ::. . - ...... -:.,< ...... 1 ...... i ...... - . : .... ? ...... - :.-. : _. 'Physician should indicate expcrintntal drugs, radioisotopes, -. . -.._.... - .: 1 radiation thc~apy,and/or possible placebo or sham therapy. .I ..; . I .... .- '...... r ....L. . I ' ..- .%... .. - '.i . i i ? i

. -'-- *-,. ....---~-,.,'z--.-.-~~~-~ . .- ...... , ...... -.---.---.-ccm ...... -...... -- .. ,. '..b.. :- -: -...... -...... -. -...... *...... - : .... ~ - ...... :...... - .* ...... -...... ---..,.. . . *. ._ ' ...... , -. - . . -..... :., . . -...-.-, :. -...... I .. .. - ...... ,...... 8 ...... I .;...... !. J ...... - .: ...... : . .. -...... _ .. --'_.__-- ...... -_- . .___.___... .__.__ .__... -. ..--- ...... -.--...... - -.--- .. -. '.-I-.. -. .... The Oak Ridge Ir:t!tute of Nuclear Studies (ORINS) Sedical Research Hos ita1 is .-;erattd by Oak Ridge Associated Universities (ORCIU) for tKe U. S. ::mic Energy Cozaission. (AX) for the conGuct of certain clinical r-scarch prograns. There prograns re mainly in areas allied to :Y.c ~pplic~tionof radiation and radioisotopes to iedicine and other health sciences.

I understand th.7.. I have been accepted as a patient for ~

I further unde7:rznd that while a patient at the research hospital exarninaticas, treauents, and tests nay be prescribed Knich art cxpcrinen:;: in nature and I hereby consent to such ex- aninations, trcatnez--s, or tests. Sotwithstanding the above, I reserve Khe right to 2 full explanation cf any such exanination, test, or treatsent and the right to wit sezt. ? further re:rF\'e the right to withdraw I fjnd that I an unzi:? to continue. I further under::;nd that I can renzin in the research hospital only so long as 1 an ;.-.:t.ded for research PUTPCSCS, and that ? .nust be discharRed when zv rarticipation in a study is coopleted and uhen, in the opinisn of tht ;.ospital staff, my medical condition permits. In such event, I witt;:tand that OWU, its officers, ezployces, and agents, c~nnotassu:? ;espon6ibility for any continued nedical care.

The above staterczts hzx-e beer. explained to ne by the mczber of the Medical Division staff name(' beiou. I understand and acrtFt :kt statemenrs. - - I have not been .>fluenced in Baking this agreewnt by any reprtsentztions OT 5: r Tements regarding itprover.enr in ny physical condition OT the ?rtf:5lc results of any trtatrcnts received, but instead expressly a:::== all risks incident to cy hospitalirrticn, !'

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.... OAK RIDSI? ASSOCIATED VNIVEREilTlES - 3' 3' II 67 Oak Ridge, Tennessoe Patient Adrsfttanco Agreemnt

The Oak Ridge Institute of Nucloar Studios (ORXNS) Hcdical Research Hos ita1 is operated by Oak Ridge Associated Universities (OUU) for t R c U. S. Atomic Enorgy Comaission (AEC) for the conduct of certain clinical research prograas. These progrncs are mainly in areas allied to the application o€ rtidiation and radioisotopes to medicine and other health scienccs.

I understand that I have been occcptcd as a pcitieat for admission to the hospital, or as an outpntient, becsusc KY physical condition has been determined by the hospital staff to mke cc P suitable patient for ;1 currently active clinical research project. I further understand that while a patient at the research hospital examinations, treatnents, snd tests may be prescribed which arc experimental in nature and I hcrcby consont to such.examinations, treatments, or tests. Notnithstanding the above, I reserve the right to a full explanation of 2ny such roposed examination, test, or treatment and the right to witR draw ny consent. I further reserve the right to withdraw con7letely should I find that I am unable to continue. 1 further understand that I can remain in the research hospital only so long as I an needed for research purposes, and thst I aust be discharged when ny participation in a study is completed and when, in the opinion of the hospital staff, my medical condition permits. 1 In such event, I understard that OUU, its officers, employees, and agents, cenxiot zssume responsibility €or any continued medical carc.

The above statements have been explained to ne by the member of the Medical Division staff named below. I understand and accept the stat cments . I have not been influenced in making this agreement by any representations or statements regarding inprovecent in ny physical condition or the ?robable results of any treatments received, but instead expressly assume all risks incident to my hospitalization, care, and treatment.

Fat ient ' s s ignature Medical Division staff member's s i gna ture

Date

......

. .-_..

.. 1022335 I .__.

...

I i

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1022339

...... /W&h

.. .

DRAFT EXPRESS =LANT

Review - Felling and Kannan

Tennessee Supreme Court Rejects Application by Sexton To Review Appeals Court Decision

The Tennessee Supreme Court has rejected an application filed by & Sexton which requested that court to review a decision of the State Court of Appeals which was favorable to ORAU in the case Sexton versus ORAU. The Supreme Court held

i, that the application seeking its review was not fisC;a, within time specified in its rules.

The original suit was filed in Anderson County Circuit Court in 1981 by Mary Sue Sexton, the mother of a patient who died in ORAU's former cancer hospital of acute leukemia in 1968. That court dismissed the case saying that its filing came after the statute of limitations had run. The court rejected plaintiff's allegation that there had been fraudulent concealment by ORAU. It affirmed its holdingwhen asked by & Sexton to reconsider them. The plaintiffs appealed that decision to the Tennessee Court of Appeals, Eastern District. The three-judge panel reviewed the decison and affirmed the trial court's ruling in June 1984. The plaintiffs had the right to request a review by the Tennessee Supreme Court but they filed beyond the time established by law for seeking review and the Supreme Court declined to review the decision of the Court of Appeals and

1022342 --AL ALL&^ Court, The plaintiffs have ar ?d the Supreme Court to reconside. its holding. +ALw A hearing by a subcommittee of tpe U.S. House of Representatives in September 1981 witnesses,and 4 LA crQ/LcccpLJ documents.mu ~~~JJ.. a hs A reached-the decison that the chrgengal’nsfORAU had-bee& “essentially refuted” by the

__ testimony, - - --

1022343 STATEMENT USED BY NASA IN ANSWER TO INQUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000* funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to satisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8/20/81 STATEMENT USED BY NASA IN ANSWER TO INOUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000* funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to sstisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8/ 20/81

1022345 STATEMENT USED BY NASA IN ANSWER TO INQUIRY:

The facts are that NASA learned of the studies being conducted and in 1964 requested that the agency be supplied with data in a form that would be usable to it to study what astronauts might expect when and if exposed to radiation in space. NASA funding went mainly to obtain this data in proper form. Some $65,000* funds did help to pay for some patient monitoring equipment. The Oak Ridge people categorically deny that the studies of cancer patients were in any way changed or extended to satisfy NASA requests nor were any such requests made by NASA. *estimate to be verified

8/20/81

,./ il , . .. I .. .

How Much Radiation Can AnAstronaut Withstand? NASA Used Dwayne SextonTo Find Out.

he dimly lit hallway weaved left and right like designed chambers at the Institute of Nuclear Studies in Oak a maze. Clutching Dwayne's small hand, Ridge, Tennessee. Medical confidentiality has prevented Mary Sue Sexton fell in step behind the identification of most of these patients. Iniorniation prolrided white-coated technician, They passed a con- by medical personnel at the facility and a telephone canvas- trol panel and walked through a wrought- sing of one area of Tennessee led to the unfolding stor)' of iron gate into the chamber. The room was Dwayne Sexton and how he was used to obtain data for the dark except for a brilliant halo over an emp- United States' space program. It is hoped that the publicatioll ty, aluminum bed. of this account will spur other patients who went through Dwayne climbed over ehe nylon net sur- these experiments or their families to come forward with rounding the bed and settied into the trough-shaped berth. more information about the controversial treatments. Mary Sue exchanged reassuring smiles and a hesitant wave Based on an 18-month Mo~hcrJoiies investigation and a with her six-year-old son. Then she turned and stepped back review of thousands of paps of documents obtained undcr out to wait in the hall. the Freedom of Informati011 Act (FOlA), it appears lhat the Mary Sue could not see the eight cones pointing toward radiation treatments began as a legitimate atlempf to im- Dwayne from the snadows, but she i- prove cance; therapy techniques. could hear a slight hum as the shielding Iiowever, dozens of intenwsrs, tile was removed and the teletherapy ma- Freedom of Information Act ~OCW chines began bathing tne young boy in merits and consultations with leading what one of the doctors later called 2 medical and scientific authorities reveal that these treatments evolved into something quite different: 0 The Oak Ridge Institute, where the treatments were conducted, was an Atomic Energy Commission (AEC) 7 tion sickness syndrome-preciseiy how clinic used for simultaneous research large a dose it would take to cause a ?* experiments on animals and humans. person to lose his appetite, get nauseous e Leading authorilies on radiation and vomit. protection, and even rlie .4ECimlfiii its review of these experiments. judfcd that the treatments were of littlr. exposed to IaFgc doses of radiation be- . if an!. benefit to the patients. The nian tween 1960 and 1974 in two speciall! \vho oversaw the expcriments. 11~~- MOTHER JONES ever, is today one of the government’s chief experts on the Today Oak Ridge’s broad, main avenues are still lined effectsof radi a t’ion. with Army barracks, converted and refurbished as apart- e The government doctors administering the treatments ment buildings. The “downtown” area is a modern shopping knew of other therapy techniques-using either different center. The denizens of the “Energy Capital” are a curious types of radiation exposure or chemotherapy-that were mix of rural-bred hill people and scientists and technicians superior. At least in Dwayne Sexton’s case, the government from around the world. One out of every 35 Oak Ridgers scientists at Oak Ridge initially withheld these better- holds a Ph.D. degree-one of the highest per capita ratios in established cancer treatments. the nation. e The clinic facilities were “substandard” according to the Clarence Lushbaugh arrived in 1963 to head the AEC government itself, and the AEC eventually forced its own clinic’s ominously titled “Applied Radiation Biology Divi- clinic to close down. sion.” A short, balding man with a combative personality, 0 Patients did not offer theirful!! informed consent to be Lushbaugh likes to say he “grew up in the gutters” of Cincin- part of some experiments. nati, Ohio, where his name, And some patients, like Clarence, “was a fighting Dwayne Sexton, were sub- name-you had to protect a jected to several different name like Clarence.” Most types of cxperiments. of his friends now call him e Though the treatments “Lush,” but the feisty atti- 1 II It 4 were administered as can- tude of his youth has not cer therapy, one primary mellowed much in 65 years. purpose was to obtain data The nameplate behind for the United States’ space Lushbaugh’s desk infoinis program on human reac- visitors that he is the tions to radiation. HSOBIC-Head-Soil-Of- a-Bitch-In-Charge. pzzzi=== Educated at the Univer- sity of Chicago, where lie NASA, the National Aero- received his bachelor’s de- nautics and Space Adrninis- gree, a Ph.D. in pathology tration, urgently needed and an M.D. in medicine, data on human sensitivity to Lushbaugh began his career radiation, and the cancer in 1949 as a pathologist in patients who came through Los Alanios, New Mex- the doors of the Oak Ridge ico-another “atomic city.” Institute of Nuclear Studies He doubled as the govern- became the human guinea ment town’s coroner. In pigs who provided thi information. 1963, Lushbaugh moved to rural Tennessee and b,-came a Animals had been the first to breach the boundaries of member of the staff of the Oak Ridge Institute. space. Dogs and chimpanzees and monkeys were metamor- “In Los Mamos,” he explains, “we had plenty of radioiso- phosed into avian creatures, hurtling through the strat- topes and plenty of macniner)., but we didn’t have a \~l~olclot osphere atop rockets. Down below, scientists were wrestling of sick peopie because it was a rather young population.” with unanswered questions about how human beings would Oak Ridge offered the same access to radioisotopes plus a stand up to the effects of radiation. Nausea and vomiting large group of Tennesseans who were grateful for free iiiedic- caused by radiation sickness were possibly manageable ail- a1 attention 2t the AEC clinic. ments on the ground. But to an astronaut wearing an oxygen The Oak Ridge Institute had a mandate from the Atomic mask, they could prove fatal. Energy Commission-which was then the government agen- Hard data on human radiosensitivity was vital to NASA. cy charged with promoting nuclear energy-to conduct re- But who would volunteer to be exposed to potentially lethal search into the “beneficial applications of radiation.” Some doses of radiation? In Oak Ridge, Tennessee, a pathologist significant achievements did come out of Oak Ridge’s clinic, at the AEC’s clinic, Ciarcnce Lushbaugh, agreed to search including the development of a cobalt 60 (C-60) teletherapy for some of the answers NASA wanted. machine, which served as a prototj‘pe for others now used in Oak Ridge is called the “Energy cancer therapy at hospitals across the country. Capital of the World” nowadavs. It Lushbaugh was teamed with eminent hematologist Gould U 1used to be known as the “Aiomic Andrcws. Lushbaugh‘s star was rising. Andrews “was prob- City.” This was the town created by Uncle Sam to produce ably the world-renowned expert in taking care of persons fuel for the Manhattan Project‘s A-bombs during World War with radiation Injuries,“ Lushbaugh says modestly, “and I 11. Hiddcn in hollo\vs amid rolling hills of black onk. massive wz the worid-renowned expert a1 t~ingto figure out Ivhat factories for producing bomb-gradc uranium rose up within a went wrong at the autopsy table.” perimeter of total military security. The limestone ridp If someone was acutely irradiated in an accident. no matter along the snaking Clinch River offered natural protection when or where, Andrews upas called in to give nie6ical atten- from air attack. Power from the Tennessee Valley Authority tion. His hunched figure \vas unmistakable-he was afflicted was in plentiful scnply. with extrcmc cun’ature of the spine. Andrcws was a compas- MOTHER JONES

sionntc and competent attendant to huhpatients, but whenev- at Sloan-Kettering , J an X-ray machine to spray their er his medical ministrations failed, it was Lushbaugh’s turn. patients, but the Oak Ridgers thought that radiation- Lushhaugh did the autopsies. emitting isotopes like C-60 and cesium 137 (Ce-137) would Shortly after his arrival in Oak Ridge, Lushbaugh won a be more flexible than a bulky machine. NASA contract to conduct a retrospective analysis of the Lushbaugh explains it this way: “See, with an X-ray lube, effects of radiation: a hunt for the point at which the syn- you would put the person on the floor in the fetal position, drome symptoms appear. He looked for clues in the medical with his knees drawn up, and you’d zap him from the right charts of cancer patients who had been treated with side with an X-ray machine and then you’d ilip him over and , radiotherapy. By the end of 1964, Lushbaugh had compiled irradiate him from the other side.” The METBI facility was a data on more than 3,000 patients at 43 different hospitals. quantum improvement. But the retrospective analysis had its limitations. The pa- The doctors could zap their patients in a specially designed tients had received varying doses of radiation, and their room with doses ranging from I .8 rads per hour (1.8r) to 3cK) doctors had not kept de- rads per hour (303r). These tailed notes on reactions in .I are extremely high doses- the systematic manner of a an ordinary chest X-ray is research scientist. A “pro- about one-tenth of a rad- spective“ study was but theexposures were and needed. Oak Ridge was the are considered therapeutic ideal place for the study and in treating some cancers. Lushbaugh was the ideal But as we will sce in choice to conduct it. By Dwayne Sexton’s case and carefully monitoring pa- those of the other 86 patients aurin$ and after tients in these experiments, radiotherapy at the clinic, the massive radiation doses Lushbaugh and his associ- were not only part of a ates could be on the lookout treatment plan, but also a for syndrome symptoms way of gathering data for and could correlate them the space program?. with the exact dose of radia- The treatment of leuke- tion received. mia patients in METBI began as soon as the facility was operational. Gould Andrew directed the clin- In 1960, the Oak Ridge clin- radiation, The project upporerrtiy began as an attempt to improve ical hematology staf€. Lush- ic had begun operating a cancer therapy. Ultimately, the experiments benefted NASA. baugh monitored the cancer patients for signs of the METBI-the Medium-Exposure-Rate Total-Body Irra- syndrome. Many aspects of the sindrome were already diator. Built in 2 special wing of the tiny clinic, METJ3l was known even then. The government’s handbook for the holo- designed for experiments testing spray irradiation as a treat- caust, The Effects of h’uclear Weopom, reports that “for ment for blood cancers. It was part of the Atomic Energy doses between 200 and 1.OOO rads the probability of survival Commission’s effort to use its nuclear wares to find those is good a! the lower end of the range, but poor at the upps “beneficial applications of radiation.” end. Tie initial syniptoms are simi!ar to those common in Prior to World War 11, researchers at the Memorial Sloan- radiation sickness . . . the larger the dosc, the sooner will Kettering Cancer Center in New York discovered that by these symptoms develop.” spraying a leukemia victim’s total body with X-rays, the As part of the fedcrally funded Oak Ridge Associalcd radiation could be used to depress the bone marrow and kill Universities-a consortium of 50 colleges and universities c:\ncerous blood cells forming there. Then, during the w3r. throughout the South-the AEC clinic had a ready-made scicnlists found that injections of radiophosphorus and sever- network from which to draw patients- Doctors in the rural al nitrogen mustards could achieve essentially the same re- South regularly referred cancer patients to Oak Ridge. sults at only a fraction of the cost. “In essence,” said one of Among them were people suffering from Hodgkin’s digease, lhc AEC‘s consulting physicians, “spray irradiation techni- chronic lymphocytic leukemia, chronic granillocytic leuke- WC.‘ \wesuperseded by simpler and better techniques.” mia, polycythemia rubra vera, idiopathic thrombocythemia . l-llshbaugh apes. “The hematologists began using these and lymphosarcoma cell leukemia. IllWwmustards,” he says, “and so they began hogging all The Oak Ridge researchers began their study by exposing tllc\C Paticnts with leukemia. . . . Well, obviously, the patients to 50 or 100 rads at a time in the METBI chamber at r;LLilc)lili.rapistsand the whole damn field of radioiogists were a rate of 1.5 rads per minute. According 10 an internal ncl: ?()1:1: to put up with that. So they came along with a prosress report written in 1970, doctors involved in the ex- 4!‘l~’1:: for doing the same things as the nitrogen mustards. periments apparentl\r never realiy thought these large doses !~~~~’~~~f‘fcrcncebeing that] you don’t have to hoid the guy would benefit the patients much, but since thc cancer victims d(’\\l?;Irld stick needles in him.” would probably require radiotherapy anv\vay, the scientists li i~~l~they came along with at Oak Ridge was bfEB1- at Oak Ridge hoped to ob:ain some of the syndrome dais iL1’,i ;h [’CW twist in the technique of spray irradiation. Doctors NASA wanted. “It was no! our plan to evaluate thc long- .. ‘~’‘?‘Y C‘ Chh hdq? Cirormed ~~~~~rs,v~~~ I SEPT./OCT. 1961 1022350 33 --? ,, MOTHER JOKES range effectiveness of these relatively large individual to Talmon: Dwavne ha~u~mph~(.~~u~en~~~., doses,” Andrews, Lushbaugh and their colleapes explained Two dajc later Mary Sue wrote in her journal: “The in the report. “This would have required establishing a total medical staff discussed a type of treatment they would like to treatment plan with this technique, which we were not pre- try on Dwayne. It was stated it could possibly be a cure for pared to do.” him. We know there is no hope at all for Dwayne except for a The scientists wanted to “be able to add or substitute other short life for him of from six weeks or maybe up to a year and forms of treatment,” which is not surprising, in fight of the a half, and he would be so sick so much of the time.” fact that the doctors virtually admitted that the METBI Mary Sue and Talmon agonized over the decision. “We exposures were not even the best method of treating the cancer decided it was woflh the risk we would have to take for a patiejirs witlr radiation. “One should not infer from this chance at 3 cure for Dwayne,” she noted in the journal. “We study,” they wrote in a candid assessment of the experiment, were reassured that the experiment was promising enough to “that we expected these individual or infrequently given take a chance with.” exposures to produce better The doctors told the Sex- clinical results . . . at pres- tons that D-e ent, we feel that some pat- was virtuams. tern of fractionated expo- Tney mentioned thal there sure [small doses of iadia- were various possible treat- .on in several treatments] ments but pointed out that, probably offers a preferable at best, all the treatments approach for total-body might do is provide a tem- radiotherapy.” porary reprieve. The Oak What these large, single Ridge researchers then ex- exposures in the IvfETBi plzined that they were in- chamber did offer was the terested in “bone marrow best opportunity to monitor transfers,” Mary Sue re- for the radiation sickness calls. “They said it was ex- syndrome. According to a perimental and would kill report of the experiment the leukemia cells. They . provided to NASA, at least offered that as an aherna- two patients at Oak Ridge rive. We took it as a desper- received doses of 503 rads ation inove for the health of prior to a treatment called our child.” “bone marrow transplanta- I tion. ” 0bviousl y , these two I people were ideal subjects I for the doctors involved in Both Dwayne’s parents 1 the NASA study to monitor for the syndrome. signed a consent form drafied by the Oak Ridge doctors. It It was June of 1965 and the reads. in part, “We understand and agree to a special ex- humid air was just hinting at perimental procedure designed to try to help our child who the oppressive Tennessee has acute ieukemia. This will consist of removing bone mar- i summer ahead when three-year-old Dwayne Sexton first row from tie child. subjecting the inarrow to radiation de- i took sick. The auburn-haired boy just wasn’t his usual self. signed to kill the leukemic cells and subsequently injecting i First-born child of Talmon and Mary Sue Sexton, Dwayne these cells inro the mother . . , there are some risks involved had his daddy‘s dimpled chin. his mother’s wide, brown eyes for both mother and child. The nature of these has been and enough energy to keep them both busy. That summer he expiained to us, and we are willinS to accept thein.” changed. “Dwayne just wanted to sit or lay down.” his in fact. the signing of the form by the Sextons did not reall!. mother remembers. “He was tired, run-down.” constitute “informed consent.” Dwayne’s parents were 1 They visited the family doctor. who diagnosed Dwayne as apparently misled into believjnc that the experimental bone anemic and prescribed liquid iron and vitamin B-12. The marrow transfer was his best and onlv hope for survkd 7 treatment didn’t help much. Dwayne’s normally rosy cheeks However. that treatment was clearlv untried. and several remained pale and waxy. Mary Sue insisted the doctor hos- better alternatives for treatin? acute lymphatic leukernis pitalize him and find out what was wrong. Blood transfusions were wideiv known and availsble. According IO Dr. Peter i began in an attempt to counter the anemia. Finally, Mary Sue Wiemilr. director of the Baltimore (Maryland) Cancer Re- f asked the doctor point-blank: “Does Dwayne have leuke- f search Center and a former official of the Naiional Cancer I mia?” The physicIan said no. and then suggested that maybe Institute, a therapy protocol consisting of several chemical the cause and cure ofI3wayne.s illness could be found at Oak agents was the “common treatment at that time.” Ridge. arra2gemen1s had alrcady bccn made. Mary Sue Instead of chemotherapy. eigllt days after his arrival a: began keeping detailcd notes in ;I journal. Oak Ridge, Dwayne was ~4xxledinto the clinic‘s sur@! On .hl\’37,Dwync clicck~dinto the Oak R~dgeclinic tor arena and sedated. none marro\s’ \vas careful]!< estractd the first time. A chesr X-ray was taken and bone marrow \vas through sc~~cI!rcc~~punctures in his legs, hips and breastbone withdrawn from his hip for ;1 test. hla?, Sue jus1 happcncc! b!, Thc marro\v \\;l< the11 irmdiatcd-probahl), in th:: hfETRi a Toern whcre one of tlic doctors \v;is confiding the bad news chamber That aft?] noon. the irradiated bone marrow w i

SEPT./OCT. ! 06 1 - IO2235 I 34 ‘‘SerUm’’ was filtered and then injected into Dwayne. vital functions of patients as The doctors had hoped they underwent these new that hlary Sue’s healthy radiation treatments. The body would build up anti- 65-foot umbilical was used bodies, which would de- to search for syndrome stroy the lcukemic cells in- symptoms. jected into her. Then. the By monitoring read-outs. antibodies in her blood technicians could watch for serum could be used to fight subtle changes in respira- the leukemic cells produced tion that would indicate in Divayne’s bone marrow. nausea. The syndrome But by mid-November of study had adt’anced to the 1965. it was ciear that this point where the doctors experiment had failed. knew a patient was about to Dwayne Sexton’s condition get sick and vomit before was worsening. the patient did. “It was a superb idea,” The patients “would real- ays the Baltimore Cancer ly run the whole thing,” Center’s Peter Wiernick. Lushbaugh explains. “Just “But you just cannot do by [the patient] opening the those things in humans first IiIspicture of rhe Sexton family was taken it1 Scprcrnber 1917, aboirl door [to leave the cham- thing.” Medical authorities ia;-ear beforc Dwoyae, on the right, died at the Oak Ridge clinic. ber], the whole thing would contacted by Mother Jones turn off, and he’d go out 1agreed that it is simply unethical to inject cancer cells into a and take a leak and go buck in, and somebody would bring 7 h@hy hu-ing, uniess 11 . in him his meals.” Dwayne’s case, it was n- Cd, wort was Lushbaugh was successful in corning up with dara that already proven. were readily available at the time. Today, helped determine how much radiation it took to induce the research into cancer therapies using antibodies is still under syndrome. But NASA still \ranted to know whether milder way at several facilities. including the National Cancer Insti- symptoms of radiation sicknss might reduce an astronaul‘s tute. Yet even now, 16 years after Dwayne’s treatment, the ability to perform routinc tasks in space. experiments are conducted largely on laboratory animals and A series of strategically on human cancer cells in laboratoq dishes. DWAYNE’S LAST CR]SjS placed mirrors enabled h4ilT After the failure of the bone marrow transfer. the Oak EzzzlSue to watch Dwayne in the Ridge Institute doctors belatedly began treating Dwayne AIETBI chamber. He thumbed a vdl-worn comic book Sexton with chemotherapy. contentedly while the machincs were turned on. Just four The Oak Ridge researchers were col- months shy of his scvcnth birthday. Dwayne had become lecting syndrome data in earnest at all-too-familiar with thc routinc of hospital life. Over three that time, but the METBI facility had and a half years, he had spent countless days at the Oak its problems and limitations. In addition, the Oak Ridgers Ridge clinic. Despite the f;iilurc of the bone niarrow transfcr. had a new theory they wanted to test: Could they alleviate chemical therapies had kept his leirkcmic cells in.rcnyission- some of the side effectsof the thempy by using lower doses of until this new crisis. radiation over days or even weeks of continuous exposure? Mary Sue silently mumbled a prayer. On Thanksgiving i By 1967, the AEC had financed the construction of a Eve 1965. blood had begun trickling from Dwayne‘s noslriis i second facility at Oak Ridge: LETBI-thc Loiv-Exposure- and ooziny from the bad. of his throat. hfary Sue could no! I RXCTot;rl43ody Irradiator. The difference bc.:u.cen it and slop the hcmnrrhaginp. The Sextons sped thc 7O-mile drive hlETG1 was like the difference between thc Ritz and a from ?heir home in Rohhins. Tennessee. tk;lhg hotel. In fact. the paneled LETEi chambci \vas Now. she watched ansic~uslyas DLvaJrne began to fidgct on 1 spccific:illy ticsigned and furnishcd to look like an ordinary the aluminum bcd. The only hopc for prolonging his life. the 1 I hoti.! room whcrc patients undergoing thcripy could rclas dactors said. \vas to cicprc\\ Ihsaync’s boric marrow with a SEPT./OCT. I96 1 35 1022352 hIOTHER JONES larfc enough dose of radiation to kill the c;incer cells growing On thc contraq. thc cvidence indicates that patients were there. It ~';tsrisky. The aIiiount of radiation u*ouldalso kill riot receiving "exquisilc care ." The physicians' judgrnents of other cells ilnd effectively knock out his body's immunity to which therapy might be most beneficial to the paticnts may bacteria. Dtvilync would have to be closely guardcd against have been clouded by their desire to come up with "beneficial deadly infcction. applications of radiation" for the AEC and syndrome data From METBI, Dtvayne was uheeled into the nearby for NASA. The cancer paticnts who qme to the clinic for LETBI chamher. which the Oak Ridfe doctors were using iis help became. in effect. laboratory animals'. ! a gerln-free isolation ward. The unibilical monitor was In a confidential report. members of the AEC review team strapped around his waist. The doctors told h.1ar-y Sue they that \kited the clinic in 1974 expressed their uneasiness with I tlecdetl to watch his vital signs carefully. They didji'r tell her the low quality of the facility and the poor patient care. They they were using the ~rrnbil~calto collect data for their NASA characterized the nuclear nicd~cineprogram as "vev pedes- study. Dwayne Sexton accepted this latest radiation therapy trian" and gave the clinical hematology division "an unfavor- without a whimper. able rating." But more im- "That radiation dose ponantly. the revie\vers dis- they gave Diva)rne may covered that some patients havc donc the job," hlar! at the clinic ma)' have had Slit says IKW+ of the attempt their lives jeopardized: just to arrcst the growth of the beneath the wooden floor cancer cells. .'hut 1 think it of the LETBl chamber. the done it a bit too muc!i. pos- Oak Ridge rcsearhers had sibly." In the following suspended on plastic cords weeks. D\vayne's weight approximately 50 cages of dropped b\- half 10 less than laboratory mice. 30 pounds. Leukemia patients, espe- He barely had the cially those undergoing strength to lift his hrzd off radiotherapy like Divayne the pillow. but he enjoyed Sexton, are virtually de- picking through a tlood of fenseless against infection. letters and Christmas cards, In hospitals they are care- which pourcd in from rela- fully isolated from any rives and friends. Mary Sue source of harmful bacteria. slept beside Dwayne in an Yet. at Oak Ridge, the chi- empty bed. keeping a con- cians were experimenting stant vigil. "Dwayne didn't by irradiating mice and men care what they did to hini," simultaneously and thus, she says. "as long as his according to the AEC re- Mommy was there. It \vas like a fairy tale. He was such a port, exposing the patients to potentiafv deadly infection brave little boy." from the animal cages hung directly below the LETBI treaf- Dwayne knew intuitively his life was ending. "Don't cry, ment chamber. Monimq." he told h.litc Sue as she stroked his forehead. Twice a week, animal caretakers crawled bet\ieen the "l'm going to be with Jesus." inner and outer shells of the LETBI facility to providc fresh hledical science has its own system of food and water for the mice. They carried the dirty cages judgingodvances in treatment andther- "through the patient area to an elevator and down to the cage app)'.Teams of doctors with expertise in washer," noted the AEC review report. "This entire the particuiar area of research carefully consider and evalu- arrangement seems to be questionable because of the neces- ate their fellow doctors' projects. sity of transporting the animals. animal wastes and equip- On several occasions during the LETBI and METBI ex- ment through areas used by patients who frequently have , periments, inspectors from the AEC visited the Oak Ridge compromised host defense mechanisms." In other words, clinic. Judging by the documentary records available, most of patients whose bodies are incapable of fighting off infection. the so-called peer reviews by doctors who scrutinized the "This area," the reviewers wrote, "would appear to be highly facility were less than laudatory. One reviewer charged "the prone to severe infestations of vermin.'' I directors nwen't .

conwkmxi them to be of enough scicntific quail!) .’I In his financed that,” Bibb says “With or without the NASA report’s summary. Lushbaugh cautioned that the studies stud).. that program would hnvc gone on.” Yet, Lushbaugh’s should ”not be considered definitive.” In fact, the expcri- 1975 report to NASA clearly states that “the radiobiologic rnents raised more questions than they answered. studies” were “carried out with joint AEC and NASA SUP- In their confidential report, port during the years 1964 to 1974.” NASA’s support was fiuancially crucial. especially in the experiments’ final years. basted the researchers for According to Allen Webb. chemist at the clinic during the their work, which they labeled “dismal.” The report explicit- experiments. “In the early 1970s. Lushbaugh had to kick y ly saps the METBI and LETBI programs evolved “without asses and pull strings to get enough money to keep LETBi adequate planning, criticism or objectives.” The bone mar- running. NASA provided the monies.” row transplant experiments received especially harsh criti- Lushbaugh himself estimates that during the ten years cism. “In‘view of’accepted NASA spgnsored his re- therapeutic modalities, search, the space agency ethical questions were provided ”three or four mil- raised with respect to the lion dollars.” The records protocol: employed in these available are limited to the studies.” the confidential period between 1969 and AEC report read. 1Y76 and account for pay- The chamber experiments by NASA of onl!. ments didn’t even result in 5799,766 of the total any appreciable iniprove- amount. Lushbaugh‘s CO~- rnent in radiotherapy tech- league. R.C. Ricks-tvho niques. “There IS little if any coauthored .the report for clinically useful data on the NASA-says that with the METBI and LETBI pro- exception of about $5.003 grams,” one of the AEC re- he spent for bicycle ergo- viewers wrote in his con- mctry equipment, NASA fidential report four years paid his salary and Lush- later. “LETBI has been baugh‘s salary. arid the rest used long enough to estab- of “the funds were spent lish (if I understand Dr. primarily for salaries for Lushbaugh correctly) that a people to be at LETBI.” very low dose rate does not larencc Lushhaugh, who has testified about cxposbtg Oak Ridge Clearly. the paper trail of offer any advantage over Falienis IO radiation, nowsaw his role was not significanf. evidence leads directly to the administration of the - the space agency. An at- dose at a higher rate in small, daily fractions.” tachment to NASA purchase orders (signed by AEC officials Was the purpose of the experiments primarily lo provide and authorizing funds for the project) notes that *‘the ‘Pr-os- data for the space program? pective‘ Human Radiation Sensitivity studies will be con- In the beginning. Lushbaugh and kndrews byrote in 1970, tinued and \vi11 be increased in number in both LETBl and a principal objective of the experiments “was to seek infor- h/lETEI as more pzitients appropriate to this type of thcl-aj)!, mation that might lead to improved radiation therap!,.” are referred to us.” i5:ithout NASA nioncy, there would not However. that noble search for the light of knowledge was have been enough cash to continue. soon cornpted. “During the course cfthe stud!.,” they nore6 Did the LETBI and METBI radiation experiments actual- in their progress report, “the urgent need arose for informa- ly benefit the patients? tion on hematologic effects in man, since the Yational Aero- The AEC’s reviewers answered that question with 311 nautics and Space Administration was faced u,ith potentially unequivocal and einpiiatic no. “There has been little /high levels of radiation exposures in space exploration.” thought.” they \vrote in a disturbing assessment of the experi- L, I In short, the syndrome search took precedence. It is not ments, “as to therapeutic utility or potential long-range con- surprising that the METJ3I and LETBI experiments-with sequences.” In any medical facility, what is best for the 1 respect to cancer therapy-would get a lower priority: Lush- patient should alivays be of paramount importance: and yet. baugh and Andrews admitted in their 1970 progress repon the AEC revieutrs accused the Oak Ridge researchers of that they did not expect “these individual or infrequently ignoring whether the therapy they employed was doing an!’ given exposures to produce better clinical results” and that a good. Unfortunately. 3t least 89 cancer patients-including different radiation treatment “probably offers a preferable Dwayne Sexton-passed through the LETBl and METBI approach fo.r total-body radiotherapy.“ chambers before the governman1 came to that belated con- .. Despite ti17-m~ tblmce. Lushbaugh denies clusion and itself ordered ii hnli to the experiments. emphrttically tne suggestion that the experiments were con- Gould Andretvs left the Oak Ridge ducted principally for KASA’s benefit. He claims his moni- ;;;;kay the AEC ordered the iacii- toring progrxn u’as simply “piggybacked” onto the LETBI and joined the faculty of the mdhIFTBI cancer therapy treatments. The Energy Eepart- University of hlaryiand. Luslibau~hasserts that it was mCnt’s William Bibb also denies that the search for the --Coiitinurd on pagc .I;

“‘O’’,virh b, Horord Po,cnoe.u SEf‘T./OCT. 1961 17 ’.

MOTHER JONES tion exposure levels well belono “safe” limits. While Lushbaugh has no experience in conducting epidemiological analyses, as in this new study, he does have experience in coming up with the sort of data the government CONTJNL’ED FHOhl PAGE 37 likes. In his final report to NASA on the LETBI and METBI experiments, Lushbaugh explained that bne of his objectives Anclrews \vho determined \vhich patients should be irradi- in undertaking the project was that “these unbiased clinical ated in the chambers and how big a dose they should get. observations were sorely needed to defend existing environ- However, a number of those involved in the experiments mental and occupational radiation exposure constraints from remembered that a committee of the clinic’s staff-including attack by well-meaning, but impractical, theorists.” Lushb;iugh-made the determinations collectively. Andrews In the past, when the government faced troubles because cannot speak for himself. He died in the summer of 1960. nuclear workers or atom bomb test victims were suing Uncle Dr. Karl Z. Morgan \\‘as the direcror of the Oak Ridge Sam for injuries they sustained, Lushbaugh was counted on National Laboratory‘s 1ie;tlth Physics Division during the to offer “expert testimony” against them. That was exactly LETBl and METBI experiments. hlorgan is kiiown what took place in U.S. District Court in Las Vegas, Neva- throughout the world as the “father of health physics,” a da. on May 16,1977. sciericc dedicated to the prevention of radiation damage. He Seven years earlier an underground nuclear bomb test at is probably the leading figure or, radiation protection in the the nearby Nevada Test Site went awn‘. Scientists had mis- Unitcrl States and. as such. could hardly be called “antinu- calculated the power of the so-called Baneberry bomb. and a clear.“ Currently a professor of physics at the Georgia Insti- mushroom cloud broke through the earth’s crust and rose tute of Tt.ct~nolo_c)~.Morgan believe: that during his tenure some 10,000 feet into the sky. The cloud began drifting at the Oak Ridze national laboratory, he was sadly confused toward an AEC base camp. Setting aside their own safety, 13 about the purpose and results of the LETBI and METBI guards frantically evacuated the camp. Three of the 13 later radiation experiments. died of leukemia, apparently because of their exposure to “1 naively thought that the purpose of this nearby center unsafe amounts of radiation. Two of the widows sued the [the clinic] \vas to use ionizing radiation in the treatment of federal government. Clarence Lushbaugh testified against cancer in a manner that had been proven to offer justifiable one of the women. c hope of remission and, in some cases, a cure,” Morgan says Lushbaugh now denies he had any significant role in the L -. today. “I believe 1 wits misled, and my hope and trust in this actual operation of METBI and LETBI. Yct, to prove his program wcrc badly misplaced.” own expertise on radiation effects duririg his testimony at thc As it turns out. one of Morgan’s lifetime friends, his child- Baneberry widow’s trial, Lushhaugh describcd the I,EfI31 hood Sunday school teachcr. was one of the 89 patients who and METBI experiments. He tcstificd that “we ourselves went to the Oiik Ridge clinic for help and became a subject exposed persons to various total-body doses ol’ r;irliation. md for the radiation syndromc study. Information about the this was an ongoing study that I workcd in ;ind suhscqucntly I nature of this clinic has. for Morgan, ii special pain. became the leader of it, and we rndi;itcd pcrsons with v;iricius “The cvidcncc strongly suggests.” Vorgin continues care- kinds of leukemias in a specially dcsigncd room wlicrc thcy fully, “that the purpose of this program was not what we were actually lived in a sea of radiation with thcir daily dosc.” led to believe.” Though hlorpin trained dozens of medical Dwavne Sexton died at the Oak Ridge clinic on I>cccnil~~ doctors himself in methods of using radiation for humsn 29, 19&, a month after his last thcrapy scssion in MFI‘HI. A benefit. he says he is “appalled. overcome with consternation limited autopsy was performed. The cause of death was and filled with a deep sense of indignation” by the news that determined to be acute strep and staph infcction. the cancer patients treated at the Oak Ridge clinic really hecame ruinea pirs io: the mace program. “It causes one to It seem we only n7i.x~ yolc more wonder.” Morgan concludes, “whether & members of the As each passing day goes by medical profcssion who were respnsibie could have been Yes, our hearts have aN been broken sincere the day they took the Hippocratic oath.” Yer wefry hard not to cry Clarence Lushbaugh still has his offices at the clinic itself, You were such a bright spot in our lives but now he is the director of the Oak Ridge Associated Since thefirst day you came Universities‘ Medical and Health Sciences Division and There’s an empry place in our home . brags thar “only God can retire me.” Just months after the That will never b,e the same review team concluded its damaging report on the clinic, -from a poem dedicated to Dwayne, by Mary Sue Lushhaugh was awarded another ongoing contract, this one Sexton, written three months after his death . by the Energy Department to conduct an cpiderniological In the entire history of the United States Manned analysis of possible health risks to nuclear workers at the Spaceflight Program, not a single astronaut ever received a Encrgy Department‘s Cak Ridge plants. high-enough dose of radiation to suffer from the syndrome. Lushbaugh’s new research project could be another poten- Dwayne Sexton did. tial hornbsheil if it confirms the results of a previous stud;; cf nuclear uvrkers. That study, by Uni\rssiry of Pittsburzh Howard L. Rosetiberg is the author of Atomic Soldiers professor Thomas i\.lancuso. rcvcaieci-after 12 years oi’ (Beacon Press, 1980). He also describes hirme~far “a wirer \vork-that nuclear workers ai thc Encrgy Department‘:, atid rider” 011 the staff of Jack Anderson’s “Wm1iingto)iMer- Hmford. ii’ilshington. atomic works suffered a significant ~I-Go-Roitrtd. ” Supplemoirary research for hir article was increase in the incidence of ccrtain types of cancer at radia- con tribitrea by the En iironmental folic!* Ccn tu.

SEPT.IOCT. 196 I 1022355 4<

102235% . --

UNITED STATES ATOMIC ENERGY COMMlSSlON WASHINGTON, D.C. 20545

May 9, 1974

James L. Liverman, Director Division of Biomedical and Environmental Research

PROGRAM REVIEW OF THE MEDICAL DNIS1:ON OF OAK RIDGE ASSOCIATED UNIVERSITIES

The following considerations have led to a proposal to change the structure of the program in the Medical Division of ORAU. .. 1. Oak Ridge does not have an appropriate demographic base with tertiary hospital facilities and a range of active programs in clinical invcsti- gation.

The present clbical facilities of the Medical Division do not meet the standards necessary for accreditation.

On the basis of program evaluation and institutional environment, it was recommended that clinical investigation should not be continued at ORAU Medical Division.

2. .The nucleaf medicine program and parts of the clinical oncology program could be incorporated into the East Tennessee Cancer Center at the University Memorial Hospital in Knoxville.

This would strengthen the development of the Cancer Center and provide the necessary environment for Medical Division programs.

3. The immunology and biochemistry programs cf the Division are geographically, operationally and intellectually isolated in the present ORAU structure.

These program would be more effective in association with the 0% Biology Division.

1022359 .- L

d * James L. Liverman -2- May 9, 1974

4. The Medical Division of ORAU has been effective in conducting educational programs for physicians in management of radiation accidents and in assessment of radiation damage in man. These programs should be continued and perhaps associated with the capability to develop regional plans for the contingency of industrial exposure and accidental release of radioactivity.

Exploration of the feasibility and implication of these propositions should be started in negotiations with representatives of the concerned institutions. Several issues should be addressed:

1. The cost of providing adequate space and facilities in the Cancer Center in Knoxville.

2. The attitudes of the staff at ORAU and Knoxville concerning the amalgamation.

3. The cost and extent of new facilities in the Oak Ridge Hospital that would sery as demonstration and instructional areas for radiation accident programs.

4. Thc Lrnpact: of the proposed changes on other components of the ORAU prcgrarn.

5. The need to satisfactorily relocate personnel in the ORAU Medical r Division. k 6. The ability of ORAU to mount a broad program in the sociology, epidemiology and contingency planning related to accidental exposure of human populations to radioactivity.

Charles E. Carter, M.D. Manager, Biomedical Programs Division of Biomedical and Environmental Research

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I .

0. 4 UNITED STATES - ATOMIC ENERGY COMMlSSlON WASHINGTON. D.C. 20545

. April 16, 1974

POK several years there has been growing concern over institutional and ptogrmatic problems of the Medical Division of ORAU. The discussion of these problems which follows is based upon the comments of reviewers who visited the laboratory on March 4, 5 and 6, 1974.

'I A. The Institutional Settinq !.'

1. The clinical facilities 'are substandard with respect to licensing and accreditation guidelines and replacement is oought by ORAU through new construction in a wing of the Oak Ridge Hospital. \ 2. The Medical Division conducts an investigative program in an area of relatively low population, in the absence of a tertiary hospital program adequate for the provision of

I specialized patient populations and services, and essentially isolated from the critical climate of academic clinical investfgation.

.-3. The la&oratories in the main building vary from adequate to marginal and are housed in a structure originally designed for other purposes and a short life time. The marmoset building contains good, permanent laboratories and the biochemistry building is considered to be sound and provides good laboratory facilities. The separation of these facilities makes effective interaction of professional personnel and the synergistic development of programs virtually impossible. .- 4. The animal facilities are separated in several buildings and except for the marmoset building all are considered to be etrikingly inadequate with respect to construction, provision of animal care, quality control, separation of species, and sanitation. The animal care programs suffer from lack of professional supervision.

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B. koarams The several prosans in the Medical Division vary widely fn quality.

8. Clinical Hematology. The reviewers gave this program an unfavor- oble rating.

0.' 'Fhe Z-ETBI and LETBI programs were viewed as evolving without adequate planning, criticism or objectives, and have achieved less in substantial productivity than merits continued support. B. The marrow transplantation program came under severe criticism. 3n view of accepted therapeutic modalities, ethical ques cions were raised with respect to the protocols employed in these studies. The leadership of this program is net defined; the coordination with immunology is inef f ec rive. The number of patients accessible to the study is small and argues against the continuation of transplant clinical investigation at OWU.

2. Nuclear Medicine

a. Radiopharmaceutical program. It was recognized that Dr . Rayes had demonstrated a high degree of capability and achievement. uestions were raised about the scope and directions of the I project , the absence'of physical chemical data on Gallim complexes, and a discernible tendency for the program to drift without defined goals. The isotope production facility at ORNL is an asset to the program, but in order to be effective, a significant nuclear medicine clinical facility at a large tehchhg and research hospital is necessary. The program suffers by its present isolation.

b. Clinical program. The number of nuclear medicine procedures performed is small and the interaction with Oak Ridge Hospital is minimal. The reviewers recognized Dr . Edwards' c linical competence and the dedication which he has brought to the program. There were questions about the design and evaluation of the Gallium cooperative study which limit the value of the collected data. The bone-scan investigation of Dr. Goswitz received unfavorable review comments.

3. Immunology. The reviewers gave this program top rating. Dr. Gengozian was recognized as a productive, innovative worker with well-defined research goals. It was recommended that . increased support should be directed to this group.

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4. Biochemistry. The projects under Dr - Snyder's direction were considered to be of high priority and productive of significant achievement. It WZY felt th3t he was intellectually, as well as geographically, isolated frcm the Medical Division. The reviewers raised the question of whether Dr. Snyder might not hove more productive interactions in another laboratory setting.

5. Computer Services. This program is under the administrative control of Mr. Harmon, Dr. Andrews' administrative assistant, on arrangement which reviewers considered to be inappropriate for effective development of these facilities. In 1968 an IBM-1800 with peripherals was purchased. In 1972 a PDP-11/20 was brought in, and since then there have been efforts to interface the computers. This system is not good computer ncience. An effort to use virtual memory concepts with the .. diac through the SDI-1800 and the change of the system from the sharing to multi-Frogramming are laudable efforts, but not essential to any scientific program at OMU. Interface attempts to the Ohio Nuclear Scanner and the gamma camera were questioned because the investigators lack sound notions as to what is to be done with the encoded data. Ideas of image enhancemenb and quantitation were not well thought through. Other critical comments of the reviewers related to the in- appropriateness of a patient information data system for 2 small clinical service of eight patients per day, and to the random and unproductive interaction of the staff of the computer center with other investigators. It was observed that the use b of computer service for the biostatistics associated with the Gallium study and other data analysis programs is appropriate, but coyld be implemented with or withcut the present computer hardware.

6. Experimental Pathology. Dr . Swartzendruber , an electron microscopist with considerable experience and achievement, received strong support from reviewers for his work on the biophysics and ultrastructural aspects of Gallium localization fn tumors. There was less enthusiasm about his pursuing x-ray spectroscopy and transmission electron microscopy in anything other than collaborative efforts with available instruments at Om. heNelson, n pathologist who does the routine work of the center, has recently received training in Germany. The reviewers were cautious in viewing his entry into a demanding and competitive

10223b3 .. -4- ..

,. program concerning the distribution and kinetics of labeled circulating stem cells. Although an enthusiastic and careful worker, it was felt that his lack of research experience, training, and scientific achievement might advise a collaborative effort or some oppor tunity for supervision.

7. Radiation Accidents: Human Radiation Exposure. The broad experience of Dr. Lushbaugh and his achievement in published assessment of human radiation exposure were considered by reviewers to have great value. Although a large part of his research effort is funded by NASA, it was considered to be effectively supportive of AEC missions and well done. It was reported by reviewers that the computer services have not provided adequate consultative treatment on statistical problems. Ik, Lushbaugh's new findings on colonic cancer in one strain of

the marmoset were considered by reviewers ' to be a significant discovery worthy of substantial support.

Drn. Andrews and Lushbaugh have been an effective team in dealing with problems of radiation accidents,

8. Mfcrobiology. The comments of reviewers were generally unfavorable with respect to this program. The routine microbiolcgy of the clinical- services is handled by competent technicians and appeared b to be of high quality. Dr . Tyndall was reported by reviewers to hove little interest or background in clinical microbiology; as a result, some of the crucial studies of patients with total body irradiation have neither been followed up nor initiated. Dr. Tyndall's studies of Gallium were evaluated as being in- odequawly planned, isolated from consultation with immunolo- g€sts and molecular biologists, and not coordinated with the principal responsibilities of the microbiology. program.

9. Cytogenetics. Dr. Littlefield was appointed to work with Dr. Goh on a project supported by NM dealing with cytogenetic effects of oral contraceptives in women. When Dr. Goh left ORAU, Dr. Littlefield became principal investigator and succeeded to responsibility in a study with many methodological problems. Dr . Littlefield was considered by the reviewers to be a technically competent cytogeneticist who had performed creditably, but who had not yet matured scientifi- cally as an independent investigator, It was felt that the Medical Division had not developed a cytogenetics research program, and that much of Dr. Littlefield's effort was spent in unplanned and unused clinical supporting services. Dr, Littlefield has the potential to become a competent independent scientist.

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114). Physics and Instrumentation. The work of Roger Cloutier and 4 Evelyn Watson on problems of dosimetry was recognized as having outstanding merit. The cooperative work with Walter Snyder of 5RNL suggested that a more suitable association for work on 'dosimetry might be at OWL. The work by Gibbs on the whole-body counter is almost entirely in support of dosimetry studies.

The work of Morris was viewed as instrumentation development proceeding independently of carefully assessed needs for problem 8oLvfng. The projects were considered to be of low priority.

C. Administration of the Medical Division

In general, the reviewers were unanimous in their judgment that ORAU Eledical Division was an institution with a creditable history, but one that is now faced with serious problems. While respectful of the sdministrative leadership of the division, it was recognized . that the institution lacked the cohesion and scientific leadership Eo overcome the fragmentation of programs, variable scientific quality and inadequacy of clinical setting. These judgments, though strong in advocacy of change, were not made without recognition of the dedication and achievement of Dr. Andrews in a foxmidably difffcult situation.

Recommendations

A; Clin€cal Research Programs

The proposed construction of facilities in the Oak Ridge Hospital .w€fl not provide the clinical setting necessary for the development . and sustentnce of a clinical research program in nu&lear medicine, radiotherapy and clinical oncology. There are several options to be considered .

1. Phase out programs in clinical research.

2. Disperse those clinical programs with good competitive standing to regional University Medical Centers for independent funding.

- 3. Transfer programs in nuclear medicine and oncology to the East Tcnnessee Cancer Center at the University of Tennessee Memorial Flospital in Knoxville.

' 4, Concentrate on a nuclear medicine program at Oak Ridge which places little emphasis on clinical research and heavy emphasis on basic mechanisms, isotope production and instrumentation development in association with Oak Ridge National Laboratory.

1022355 t- ' 38 , .* I -6- ... . *# .. ..

Thefjc options were proposed and discussed in some detail by our reviewers. The concensus supported the consolidation of clinical research and supporting * programs, such as experimental pathology, with the University Hospital and . Cancer Center in Knoxville. Such a development would considerably strengthen both institutiocs,

At this time, all of the factors which will influence decisions in the lseveral institutions involved are not known; and we view this recommendaticn , 08 an opening move in a' series of negotiations, many of which depend on the status of the Cancer Center program at Knoxville,

B. Radiation Accidents and the Social Strategy for Dealing with Human Exposure to Environnental Radiation

' 1. The extensive experience of Drs, Lushbaugh and Andrews in problems of radiation accidents argues for supporting a facility in Oak Ridge which would consist of a demonstration unit in the Oa!c Ridge Hospital with laminar flow room and a decontamination area suitable for treatment of accident subjects. This facility would serve as a focus for a teaching program addressed toward physicians and public health officials who clre charged with responsibility in enviromental health planning.

2. The above program should be coordinated with a sociological resezrch and assessment progran at the ORhU campus which would address problem of preventive and response planning for environmental contamination resulting from accidents and nuclear fuel relesse. This program might develop with well-defined relationships to the "think tank" .* .* for energy options which OEWU has initiated. ). 3. It might also be appropriate at this time to think about centralizing the infornation processing and some components of the human epideai- Ology programs relating to occupational exposure and health assessment of workers at a facility such as that proposed for OUU. The computer center now serving the tledical Division might then be transferred and res trucrured to serve this function ,

. @. The hunology Program and thc Biochemistry Program should be brought into administrative association with ORXL and as soon as feasible into that laboratory. The strength of these programs and the adequacy of preaent facilities is recognized, and alternative options might be conaidered,

10223bb I .. .,

D, Thh Medical Physics and Instrumentation Frogrsn would be more appropriately developed in ORNL. The recognized merit of Dr. Cloutier's work in dosimetry would undoubtedly lead to the possibility of incor- porating his progran into 3 combined effort at the Cancer Center, University of Tennessee Hospital in Knoxville, should this proposition be developed. 'a B. In recogkzing the potential of Dr. Littlefield to develop as an . independent investigator in cytogenetics, a transfer of her proGrarn . to the cytogenetics group at O& is recommended. P. The MicroSiology Progrw might be identified with several institutions; at this time no recommendation is made.

In making these recommendations, there is recognition of the dislocation and discomfort they entail. There is a determination, however, to deal eensitively and considerately with the people involved. At the outset it should be realized that we are embarking on a series of meetings with eeveral concerned par ties ; we propose several recomendations to orient the discussions. With considerable firmness we respond to the recoc-menda- tfon of our reviewer$ and our staff that the present configuration of the . ..a. Medical Division of OUU must change. .. .*. . As a consequence of these recommendations, certain actions with respect to construction of facilities are entailed.

1. ORAU and AEC should not enter into an agreement with Oak Ridge Hospftal for the construction of a 26-30 bed clinical facility. b 2, The possibility of a demonstration accident treatment facility with an attached decontamination unit as part of the new construction being planned at Oak Ridge Hospital should be explored. This facility might contain two laminar flow rooms, offices and a conference area.

3, There should be no new construction of animal facilities.

The changes resulting from these recommendations should tdie place over a period of two to three years. /.: . .-

...... e

1022353. UNITED STATES ATOMIC ENERGY COMMISSION WA5HINGTOk4. D.C. 20545

Hay 9, 1974

James L. Liverman, Director Division of Biomedical and Enoironmen tal Research

PRoGE?AM REVIEW OF THE MEDICAL DIVISION OF OAK RIDGE ASSOCIATED UXIVERSITLES

The following considerations have led to a proposal to change the structure of the program in the Medical Division of ORAU.

1. Oak Ridge does not have an appropriate demographic base with tertiary hospital facilities and a range of active programs in clinical invcsti- gation.

The present clipical facilities of the Medical Division do not meet the standards necessary for accreditation.

On the basis of program evaluation and institutional environment, it was recomended that clinical investigation should not: be continued at ORAU Medical Division.

2. .The nucleaF medicine program and parts of the clinical oncology program could be incorporated into the East Tennessee Cancer Center at the University Memorial Hospital in Knoxville.

This would strengthen the development of the Cancer Center and provide the necessary environment for Medical Division programs.

3. The immunology and biochemistry programs cf the Division are geographically, operationally and intellectually isolated in the present ORAU structure.

These programs would be more effective in association with the OFSi Biology Division.

I U223b8 d James L. Liverman' -2- Play 9, 1974

Exploration of the feasibility and implication of these propositions should be started in negotiations with representatives of the concerned institutions. Several issues should be addressed:

1. The cost of providing adequate space and facilities in the Cancer Center in Knoxville.

2. The attitudes of the staff at ORAU and Knoxville concerning the amalgaqiation.

3. The cost and extent of new facilities in the Oak Ridge Hospital that would sery as demonstration and instructional areas for radiation accident programs.

4. Thc impact of the proposed changes on other components of the ORRU pr cgr am.

5. The need to satisfactorily relocate personnel in the ORAU Medical r Division.

6. The ability of ORAU to mount a broad program in the sociology, epidemiology and contingency planning related to accidental exposure of human populations to radioactivity.

c4ld *-

Charles E. Carter, M.D. Manager, Biomedical Programs Division of Biomedical and Environmental Research . __.. .. c

I . .

0. 8 UNiTED STATES ATOMIC ENERGY COMMISSION WaHINGTON. D.C. 20545

. April 16, 1974

POS several years there has been growing concern over institutional and programmatic problems of the Medical Division of ORAU, The discussion of these problems which follows is based upon the cornments of reviewers who visited the laboratory on March 4, 5 and 6, 1974.

!I A. The Institutional Settinq . !.'

The clinical facilities 'are substandard with respect to lPcensing and accreditation guidelines and replacement is sought by ORAU through new construction in a wing of the Oak Ridge Hospital. \ The Medical Division conducts an investigative program in an area of relatively low population, in the absence of a tertiary hospital program adequate for the provision of specialized patient populations and services, and essentially isolated from the critical climate of academic clinical investigation.

The lqboratories in the main building vary from adequate to marginal and are housed in a structure originally designed for other purposes and a short life time. The marmoset building contains good, permanent laboratories and the biochemistry building is considered to be sound and provides good laboratory facilities. The separation of these facilities makes effective interaction of professional personnel and the synergistic development of programs virtually impossible.

The animal facilities are separated in several buildings and except for the marmoset building all are considered to be strikingly inadequate with respect to construction, provision of animal care, quality control, separation of species , and oanitation. The animal care programs suffer from lack of professional supervision.

1022310 - C. 1- . -. r .. -2-

"he several programs in the Medical Division vary widely in quality.

1. Clinical HematologJ. The reviewers gave this program an unfavorable rating.

a,' %he IETBI and LETBI programs were viewed as evolving without adequate planning, criticism or objectives, and have achieved less fn substantial productivity than merits continued support.

b. The marrow transplantation program came under severe criticisin. In view of accepted therapeutic modalities, ethical questions were raised with respect to the protocols employed in these atudies. The leadership of this program is nct defined; the coordination with immunology is ineffective . The number of patients accessible to the study is small and argues against the continuation of transplant clinical investigation at OUU.

. 2, Buclear Medicine

a. Rad€opharmaceutical program. It was recognized that Dr. Hayes had demonstrated a high degree of capability and achievement. uestions were raised about the scope and directions of the project, the absence'of physical chemical data on Gallim complexes, and a discernible tendency for the program to drift * without defined goals. The isotope production facility at ORHL is an asset to the program, but in order to be effective, a significant nuclear medicine clinical facility at a large tebching and research hospital is necessary. Tne program euffers by its present isolation.

b: b: Clinical program. The number of nuclear medicine procedures performed is small and the interaction with Oak Ridge Hospital is minimal. The reviewers recognized Dr . Edwards' clinical cmpetence and the dedication which he has brought to the ,program. There were questions about the design and evaluation of the Gallium cooperative study which limit the value of the collected daea. The bone-scan investigation of Dr . Goswitz received unfavorable review comments.

3. Immunology. The reviewers gave this program top rating. Br. Gengozian was recognized as a productive, innovative worker with well-defined research goals. It was recommended that . fncreased support should be directed to this group.

1022311 I^ . -.

*. OFFICIAL !$E CNL. . '- , a. -3-

4. _Biochemistry. The projects under Dr. Snyder's direction were considered to be of high priority and productive of significant achievement. It was felt that he was intellectually, as well nS geographically, isolated frcm the Medical Division. The reviewers raised the question of whether Dr. Snyder night not have more productive interactions in another laboratory setting.

5. Computer Services. This program Is under the administrative Control of Elr. Harmon, Dr. Andrews' administrative assistant, an arrangement which reviewers considered to be inappropriate for effective development of these facilities. In 1968 an IRM-1800 with peripherals was purchased. In 1972 a PDP-11/20 vas brought in, and since then there have been efforts to interface the computers. This system is not good computer ocience. An effort to use virtual memory concepts with the df8c through the and the change of the system from .. IBt.1-1800 the sharing to multi-Frogramming are laudable efforts, but not essential to any scientific program at ORAU. Interface attempts to the Ohio Nuclear Scanner and the gamma camera were questioned because the investigators lack sound notions as to what is to be done with the encoded data. Ideas of image enhancement. and quantitation were not well thought throush . Other critical comments of the reviewers related to the in- appropriateness of a patient information data system for a small clinical service of eight patients per day, and to the random and unproductive interaction of the staff of the computer center with other investigators. It was observed that the use ,of computer service for the biostatistics associated with the Gallium study and other data analysis programs is appropriate, but coyld be implemented with or withcut the present computer hardware.

Dr. Nelson, a pathologist who does the routfne work of the center, has recently received training in Germany. The reviewers were cautious in viewing his entry into a demanding and competitive

1022312 -. -, .. e . I .. -4- ..

7. Rediation kccidenrs; Human Radiation Exposure. The broad experience of Dr. Lushbaugh and his achievement in published assessment of human radiation exposure were considered by reviewers to have great value. Although a large part of his research effort is funded by NASA, it was considered to be effectively supportive of AEC missions and well done. It was reported by reviewers that the computer services have not provided adequate consultative treatment on statistical problems. Lushbaugh's new findings on colonic cancer in one strain of the marmoset were considered by reviewers . to be a significant dir;covery worthy of substantial support.

Drs. Andrews and Lushbaugh have been an effective team in dealing with problems of radiation accidents.

8. Microbiology. The comen ts of reviewers were generally unfavorable with respect to this program. The routine microbiolcgy of the clinical services is handled by competent technicians and appeared to be of high quality. Dr. Tyndall was reported by reviewers to have little interest or background in clinical microbiology; as a result, some of the crucial studies of patients with total body irradiation have neither been followed up nor initiated. Dr. Tyndall's studies of Gallium were evaluated as being in- ndequawly planned, isolated from consultation with immunolo- gists and molecular biologists, and not coordinated with the principal responsibilities of the microbio1ogy.program.

9. Cytogenetics. Dr. Littlefield was appointed to work with Dr. Goh on a project s upported by NIH dealing with cytogenetic effects of oral contraceptives in women. When Dr. Goh left ORAU, Dr. Littlefield became principal investigator and succeeded to responsibility in a study with many methodological problems. Dr. Littlefield was considered by the reviewers to be a technically competent cytogeneticist who had performed creditably, but who had not yet matured scientifi- cally as an independent investigator. It was felt that the Medical Division had not developed a cytogenetics research program, and that much of Dr. Littlefield's effort was spent in unplanned and unused clinical supporting services . Dr, Littlefield has the potential to become a competent independent scientist.

1022313 . ..-'C .

114). Physics and Instrumentation. The work of Roger Cloutier and 1 Evelyn Watson on problems of dosimetry was recognized as having outstanding merit. The cooperative work with Walter Snyder of ORNL suggested that a more suitrrble association for work on dosimetry might be at OWL. The work by Gibbs on the whole-body counter is almost entirely in support of dosimetry studies.

The work of Morris was viewed as instrumentation development proceeding independently of carefully assessed needs for problem solving. The projects were considered to be of low priority.

C, Administration of the Medical Division

In general, the reviewers were unanimous in their judgment that ORAU Pfedical Division was an institution with a creditable history, but one that is now faced with serious problems. While respectful of the administrative leadership of the division, it was recognized that the institution lacked the cohesion and scientific leadership to overcume the fragmentation of programs, vzriable scientific quality and inadequacy of clinical setting. These judgments, though strong in advocacy of change, were not made without recognition of the dedication and achievement of Dr. Andrews in a formidably difficult situation.

Recommends tions

A; Clintcal Research Programs

The proposed construction of facilities in the Oak Ridge Hospital .will not provide the clinical setting necessary for the development . and austenSnce of a clinical research program in nu&lear medicine, radiotherapy and clinical oncology. There are several options to be considered.

1. Phase out programs in cLinical research.

2. Disperse those clinical programs with good competitive standing to regional University Medical Centers for independent funding.

3. Wansfer programs in nuclear medicine and oncology to the East Tennessee Cancer Center at the University of Tennessee Memorial Hosp€tal in Knoxville. 4. Concentrate on a nuclear medicine program at Oak Ridge which places little emphasis on clinical research and heavy emphasis on basic mechanisms, isotope production and instrumentation development in association with Oak Ridge National Laboratory. I- * -D

* 0' .- .. . # -6- ... . *a .. .'

Thew options were proposed and discussed in some detail by our reviewers. The concensus supported the consolidation of clinical research and supporting programs, such as experimental pathology, with the University Hospital and Cancer Center in Knoxville. Such a development would considerably strengthen both instftutiocs. At this time, all of the factors which will influence decisions in the aeveral ihstitutions involved are not known; and we view this recommendation . as M opening move in a' series of negotiations, may of which depend on the status of the Cancer Center program at Knoxville.

B. Radiation Accidents and the Social Strategy for Dealing with Buman Exgosure to Environmental Radiation

' 1. The extensive experience of Drs, Lushbaugh and Andrews in problems of radiation accidents argues for supporting a facility in Oak Ridge which would consist of a demonstration unit in the Odc Ridge Hospital with laminar flow room and a decontamination area suitable for treatment of accident subjects. This facility would serve as a focus for a teaching program addressed toward physicians and public health officials who =e charged with responsibility in enviromen tal health planning.

2. The above program should be .coordinated with a sociological research and assessment program at the ORAU campus which would address problems of preventive and response planning for environmental con tai-nination resulting from accidents and nuclear fuel release. This program - might develop with well-defined relationships to the "think tank" .' for energy options which ORAU has initiated. b 3. Zt might also be appropriate at this time to think about centralizing the information processing and some components of the human epideni- Ology programs relating to occupational exposure and health assessment of workers at a facility such as that proposed for 0,UU. The computer center now serving the Medical Division might then be transferred and restructured to serve this function.

. @.The Immunology Program and thc Biochemistry Program should be brought into administrative association with OR?? and as soon as feasible into that laboratory. The strength of these programs and the adequacy of present facilities is recognized, and alternative options might be considered.

1022315 c I .' , .. .. -.. . I 1

D. Th& Medical Physics and Instrumentation Program would be more appropriately developed in ORNL. The recognized merit of Dr. Cloutier's work in dosimetry would undoubtedly lead to the possibility of incor- porating his progrzm into a combined effort at the Cancer Center, -uuiJli'Sli;y of T2ikiiesace iiospii;al in -hoxville, shouia chis proposition be developed.

I -.4s n. In recognizing the pctentlal of Dr. Littlefield to develop as an independent, investigator in .cytogenetics, a transfer of her program to the cytogenetics 'group at CRkL is recommended. P. The Microbiology Program might be identified with several institutions; at this time no recommendation is sade.

lo, miking these recommendations, there is recognition of the dislocation and discomfort they entail. There is a determination, however, to deal sensitively and considerately with the people involved. At the outset it should be realized that we are embarking on a series of meetings with several concerned par ties; we propose several reconsendations to orient the discussions. With considerable firmness we respond to the recornenda- tLon of our reviewers and our staff that the present configuration of the . , .a . Medical Division of ORhU must c,hange. . .*...... AB a consequence of these recommendations, certain actions with respect to construction of facilities are entailed.

1. ORAU and AEC should not enter into an agreement with Oak Ridge Hospital for the construction of n 26-30 bed clinical facility. b 2. The possibility of a demonstration accident treatment facility with an attached decontamination unit as part of the new construction being planned at Oak Ridge Hospital should be explored. This facility might contain two laminar flow rooms, offices and a conference area.

3. There should be no new construction of animal facilities.

The changes resulting from these recommendations should take place over u period of two to three years. /. . '.

......

.... ,. .... , 6 .e... . . IN THE CIRCUIT.._ COURT FOR ANDERSON COUNTY, TENNESSEE

MARY SUE SEXTON, Mother and next friend of TALMON DEWAYNE SEXTON, Deceased, 2333 Cranshaw Drive Kingsport, Tennessee, Plaintiff i 1 NO L- d 72' vs t 1 1 Oak Ridge Associated' Universities, 1 A Tennessee Corporation listed as 1 a Non-Prof it Organization, with 1 agent for service of process being 1 Stephen S. Lawrence, Badger Avenue, 1 Oak Ridge, Tennessee 37830, -1 1 Defendant 1

COMPLAINT

Comes the Plaintiff, Mary Sue Sexton, Mother and next friend of Tahon Dewayne Sexton, and files this her Complaint and for cause of action shows to the Court the following: 1, That she is the mother and natural guardian of Dewayne Sexton, who died December 29th, 1968. 2, That at the time of his death the Decedent, Dewayne Sexton, was suffering from acute lymphoblastic leukemia. 3. That the Decedent, Dewayne Sexton, had been a patient at the Oak Ridge Associated Universities Medical Center in Oak Ridge, Tennessee, since July 27th, 1965. That during the time the Decedent was a patient at Oak Ridge Associated Universities, the treatment he received was not consistent with the standard of care which patients received in the same or similar circumstances in the same or similar localities, for lymphoblastic leukemia. That the parents of the Decedent,

1022374 Dewayne Sexton, were improperly advised of the consequences of the treatment, and there was a failure to provide adequate information so that fully informed consent could be given to the treatment received by the Decedent. 4, That as a direct result of the failure of the Decedent to receive the proper care at Oak Ridge Associated Universities,. the Decedent, Dewayne Sexton, had a shortened life expectancy. 5, That the Plaintiff, Mary Sue Sexton, had no knowledge or did not suspect any improper treatment on the part of the doctors who treated the Decedent at Oak Ridge Associated Universities until June of 1981, at which time she was informed that there could be improper treatment involved in this part- icufar situation. It has only been recently that the Plaintiff has been informed that the purpose for these programs was not necessarily the proper treatment of the patient but may have been for other motives, and thus caused the treatment not to conform with the applicable standard of care at that time. 5, That the Defendant, Oak Ridge Associated Universities, through its agents, has concealed the purpose of thcse treatments and thus the statute of limitations would be tolled until such time as the Plaintiff discovered the lack of adequate treatment in this case, WHEREFORE, Plaintiff demands judgment in the amount of SEVEN HUNDRED FIFTY THOUSAND DOLLARS ($750,000.00), and costs arid demands a jury to try this action.

520 Butternut Street, N.W. Washington, D. C. 20012 (202-882-5508)

IO22380

UNITED STATES ATOMIC ENERGY COMMISSION WASHINGTON. D.C. 20545

May 9, 1974

James L. Liverman, Director Division of Biomedical and Environmental Research

PROGRAM REVIEW OF THE MEDICAL DIVISION OF OAK REEASSOCIATED UNIVERSITIES

The following considerations have led to a proposal to change the structure o$ the program in the Medical Division of ORAU. .. 1. Oak Ridge does not have an appropriate demographic base with tertiary hospital facilities and a range of active programs in clinical investi- ga tion.

The present clipical facilities of the Medical Division do not meet the standards necessary for accreditation.

On the basis of program evaluation and institutional environment, it was recomended that clinical investigation should not be continued at ORAU Medical Division.

2. .The nucleaF medicine program and parts of the clinical oncology program could be incorporated into the East Tennessee Cancer Center at the University Memorial Hospital ia Knoxville.

This would strengthen the development of the Cancer Center and provide the necessary environment for Medical Division programs.

3. me immunology and biochemistry programs cf the Division are geographically, operationally and intellectually isolated in the present ORAU structure.

These programs would be more effective in association with the ORNL Biology Division.

1022382 c c

V .. - James L. Liverman' -2 - May 9, 1974

4. The Medical Division of ORAU has been effective in conducting educational programs for physicians in management of radiation , accidents and in assessment: of radiation damage in man. These programs should be continued and perhaps associated with the capability to develop regional plans for the contingency of industrial exposure and accidental release of radioactivity.

Exploration of the feasibility and implication of these propositions should be started in negotiations with representatives of the concerned inatitutions . Several issues should be addressed:

1. The cost of providing adequate space and facilities in the Cancer Center in Knoxville. .. 2. The attitudes of the staff at ORAU and Knoxville concerning the amalgamation.

' 3. The cost and extent of new facilities in the Oak Ridge Hospital that would serv,e as demonstration and instructional areas for radiation accident programs.

4. The impact of the proposed changes on other components of the ORAU prcgram.

5. The need to satisfactorily relocate personnel in the ORAU Medical t Division. i 6. The ability of ORAU to mount a broad program in the sociology, epideniology and contingency planning related to accidental exposure

of human populations to radioactivity. ,

Charles E. Carter, M .D. Manager, Biomedical Programs Division of Biomedical and Environmental Research

t 022383 0. UNiTED STATES - ATOMIC ENERGY COMMISSION WASHINGTON. D.C. 2054s

' AprPl 16, 1974

, ORAU WIEW

Pos several years there has been growing concern over institutional and programmatic problems of the Medical Division of ORAU. The discussion of these problems which follows is based upon the coinments of reviewers who visited the laboratory on March 4, 5 and 6, 1974.

.'I A. The Institutional Settinq . !.'

1. The clinical facilities *are substandard with respect to licensing and accreditation guidelines and replaceuent is sought by ORAU through new construction in a wing of the Oak Ridge Hospital. \ 2. The Medical. Division conducts an investigative program in an area of relatively low population, in the absence of a tertiary hospital program adequate for the provision of

I specialized patient populations and services, and essentially isolated from the critical climate of academic clinical investigation.

.. 3, The la$oratories in the main building vary from adequate to marginal and ore housed in a structure originally designed for other purposes and a short life time. The marmoset building contains good, permanent laboratories and the biochemistry building is considered to be sound and provides good laboratory facilities. The separation of these facilities makes effectivc interaction of professional personnel and the synergistic development of programs virtually impossible.

.* 4. The animal facilities are separated in several buildings and except for the marmoset building all are considered to be attikingly inadequate with respect to construction, provision of animal care, quality control, separation of species, and sanitation. The animal care programs suffer from lack of professional supervision.

t 022384 c . -'

.. -2-

D. Programs The several programs in the Medical Division vary widely in quality.

1. Clinical Hematolo3y. The reviewers gave this program an unfavorable rating.

a.' The IETBI and LETBI programs were viewed as evolving without adequate planning, criticism or objectives, and have achieved less in substantial productivity than merits continued support,

b. The marrow transplantation program came under severe criticisn. En view of accepted therapeutic modalities, ethical questions were raised with respect to the protocols employed in these etudies. The leadership of this program is nct defined; the coordination with immunology is ineffective. The number of patients accessible to the study is small and argues against the continuation of transplant clinical investigation at OUU .

. 2. Nuclear Medicine

Radiopharmaceutical program. It was recognized that Dr. Hayes had demonstrated a high degree of capability and achievement. uestions were raised about the scope and directions of the 11, project , the absence'of physical chemical data on Gallim complexes, and a discernible tendency for the program to drift without defined goals. The isotope production facility at ORNL is an asset to the program, but in order to be effective, a significant nuclear medicine clinical facility at a large tehching and research hospital is necessary. The program suffers by its present isolation,

Clinical program. The number of nuclear medicine procedures performed is small and the interaction with Oak Ridge Hospital is minimal. The reviewers recognized Dr . Edwards c linical competence and the dedication which he has brought to the program. There were questions about the design and evaluation of the Gallium cooperative study which limit the value of the collected data. The bone-scan investigation of Dr. Goswitz received unfavorable review comments.

3. hunoZop;y. The reviewers gave this program top rating. Br. Gengozian was recognized as a productive, innovative worker wf th we1 1-def ined research goals. It was recommended that . increased support should be directed to this group.

1022.385 I-

I. - .. * 0. . a. -3-

4. Blochemis try. The projects under Dr . Snyder's direction were considered to be of high priority and productive of significant achievement. It was felt that he was intellectually, as well as geosaphically, isolated frcm the Medical Division. The reviewers raised the question of whether Dr. Snyder might not have more productive interactions in another laboratory setting.

5. Computer Services. This program is under the administrative control of klr. Harmon, Dr. Andrews' administrative assistant, on arrangement which reviewers considered to be inappropriate for effective development of these facilities. In 1968 an IBM-1800 with peripherals was purchased. In 1972 a PDP-11/20 was brought in, and since then there have been efforts to interface the computers. This system is not good computer science. An effort to use virtual memory concepts with the . disc through the IBM-1800 and the change of the system from elme sharing to multi-programming are laudable efforts, but not essential to any scientiiic program at ORRU. Interface attempts to the Ohio Nuclear Scanner and the gamma camera were questioned because the investigators lack sound notions as to what is to be done with the encoded data. Ideas of image enhancement. and quantitation were not well thought throcgh. Other critical comments of the reviewers related to the in- appropriateness uf a patient information data system for a a small clinical service of eight patierits per day, and to the random and unproductive interaction of the staff of the computer center with other investigators. It was observed that the use ,of computer service for the biostatistics associated with the Gallium study and other data analysis programs is appropriate, but coyld be implemented with or withcut the present computer hardware.

Dr. Nelson, a pathologist who does the routine work of the center, has recently received training in Germany. The reviewers were cautious in viewing his entry into a demanding and competitive

102238b .'

program concerning the distribution and kinetics of labeled circulating stem cells. Although an enthusiastic and careful worker, it was felt that his lack of research experience, training, and scientific achievement might advise a collaborative sf fort or some opportunity for supervision . 7. Radiation Accidents; Human Radiation EXDOSure. The broad experience of Dr. Lushbaugh and his achievement in published assessment of human radiation exposure were considered by reviewers to have great value. Although a large part of his research effort is funded by NASA, it was considered to be effectively supportive of AEC missions and well done. It was reported by reviewers that the computer services have not provided adequate consultative treatment on statistical problems. Dr. Lushbaugh's new findings on colonic cancer in one strain of the marmoset were considered by reviewers to be a significant discovery worthy of substantial support.

Dro. Andrews and Lushbaugh have been an effective team in dealing with problems of radiation accidents.

8. Microbiology. The comments of reviewers were generally unfavorable with respect to this program. The routine microbiolcgy of the clinical services is handled by competent technicians and appeared D to be of high quality. Dr. Tyndall was reported by reviewers to have little interest or background in clinical microbiology; as a result, some of the crucial studies of patients with total body irradiation have neither been followed up nor initiated. Dr. Tyndall's studies of Gallium were evaluated as being in- adequatgly planned, isoLated from consultation with imunolo- gists and molecular biologists, and not coordinated with the principal responsibilities of the rnicrobio1ogy.program.

9. Cytogenetics. Dr. Littlefield was appointed to work with Dr. Goh on a project supported by NIH dealing with cytogenetic effects of oral contraceptives in women. When Dr. Goh left ORAU, Dr. Littlefield became principal investigator and succeeded to responsibility in a study with many methodological problems. Dr . Littlefield was considered by the reviewers to be a technically competent cytogeneticist who had performed creditably, but who had not yet matured scientifi- cally as an independent investigator. It was felt that the Medical Division had not developed a cytogenetics research program, and that much of Dr. Littlefield's effort was spent in unplanned and unused clinical supporting services. Dr, Littlefield has the potential to become a competent independent scientist.

1022387 - ‘*. c. *. . -5- 1

Physics and Instrumentation. The work of Roger Cloutier and 4 Evelyn Watson on problems of dosimetry was recognized as having outstanding merit. The cooperative work with Walter Snyder of ORNL suggested that a more suitable association for work on dosimetry might be at OWL. The work by Gibbs on the whole-body counter is almost entirely in support of dosimetry studies.

The work of Morris was viewed as instrumentation development proceeding independently of carefully assessed needs for problem solving, The projects were considered to be of low priority.

C. Administration of the Medical Division

Ln general, the reviewers were unanimous in their judgment that OMU Fiedical Division was an institution with a creditable history, but one that is now faced with serious problems. While respectful of the administrative Leadership of the division , it was recognized ’ that the institution lacked the cohesion and scientific leadership to overcome the fragmentation of programs, variable scientific quality and inadequacy of clinical setting. These judgments , though strong in advocacy of change, were not made without recognition of the dedication and achievement of Dr. Andrews in a formidably difficult situation.

Recotmend ation s

A: Clinical Research Programs

The proposed construction of facilities in the Oak Ridge Hospital .will not provide the clinical setting necessary for the development .and sustenbnce of a clinical research program in nudlear medicine, redPotherapy and clinical oncology. There are several options to be considered.

1. Phase out programs in clinical research.

2. Disperse those clinical programs with good competitive standing to regional University Medical Centers for independent funding.

3, Transfer programs in nuclear medicine and oncology to the East Tennessee Cancer Center at the University of Tennessee Memorial Hospital in Knoxville.

4, Concentrate on a nuclear medicine program at Oak Ridge which places little emphasis on clinical research and heavy emphasis on basic mechanisms, isotope production and instrumentation development in association with Oak Ridge National Laboratory.

1022388 . ?* I .' * . .. -6- .. ... e .a .. .. *.

Thege options were proposed and discussed in some detail by our reviewers. The concensus supported the consolidation of clinical research and supporting b programs, such as experimental pathology, with the University Hospital and . Cancer Center in Knoxville. Such a development would considerably strengthen both institutiocs.

At this time, all of the factors which will influence decisions in the Qeverd institutions involved are not known; and we view this recomendaticn as an opening move in a' series of negotiations, many of which depend on the status of the Cancer Center program at Knoxville.

B. Radiation Accidents and the Social Strategy for Dealing with Human Exposure to Environmental Radiation

' 1. The extensive experience of Drs. Lushbaugh and Andrews in problens of radiation accidents argues for supporting a facility in Oak Ridge which would consist of a demonstration unit in the Oak Ridge Hospital with laminar flow rooms and a decontamination area suitable for treatment of accident subjects. This facility would serve as a focus for a teaching program addressed toward physicians and public health officials who are charged with responsibility in envirommtal health planning.

2. The above program should be .coordinated with a sociological resecrch and assessment progran at the ORAU campus which would address problens of preventive and response planning for environmental contamination resulting from accidents and nuclear fuel relesse. This program might develop with well-defined relationships to the "think tank" for energy options which OMU has initiated. h 3. It might also be appropriate at this time to think about centralizing the information processing and some components of the human epidmi- ology programs relating to occupational exposure and heal t'n assessment of workers at a facility such as that proposed for 0,UU. The computer center now serving the Medical Division might then be transferred and restructured to serve this function.

. @. The Immunology Program and the Biochemistry Progran should be brought into administrative association with ORii and as soon as feasible into that laboratory. The strength of these programs and the adequacy of present facilities is recognized, and alternative options might be considered.

1022389 c ......

go Thh Medical Physics and Instrumentation Program would be more appropriately developed in ORNL. The recognized merit of Dr. Cloutier's work in dosimetry would undoubtedly lead to the possibility of incor- porating his program into a combined effort at the Cancer Center, ';diversity of Tennessee Bospi tal in 'Knoxville, should this proposition be developed. 'b IZ. In recoghzing the potential of Dr. Littlefield to develop 2s an independent investigator in cytogenetics, a transfer of her program . to the cytogenetics group at C€U?L is recommended.

P. The Microbiology Progrm might be identified with several institutions; at this tine no recommendation is made. In making these recommendations, there is recognition of the dislocation and discomfort they entail. There is a determination, however, to deal sensitively and considerately with the people involved. At the outset it should be realized that we are embarking on a series of meetings with several concerned parties; we propose several recornendations to orient the discussions. With considerable firnncss we respond to the recormenda- tion of our reviewer$ and our staff that the present configuration of the Medical Division of c,hange: .:,.. ,'e . OIWU'must ...... ' ... *.. As a consequence of these recommendations, certain actions with respect to construction of facilities are entailed.

10 ORAU and AEC should not enter into an agreement with Oak Ridge Hospital for the construction of o. 26-30 bed clinical facility. i 2. The possibility of a demonstration accident treatment facility with an attached decontamination unit as part of the new construction being planned at Oak Ridge Hospital should be explored. This facility might contain two laminar flow rooms, offices and a conference area.

3. There should be no new construction of animal facilities.

The changes resulting from these recommendations should tdie place over a period of two three years. to /. . .- ......

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