Document eybVeZMgomD8N3KRv1k41GJq

aking It "he Case Against Industrial Bio-Test Laboratories sc: y Keith Schneider ' Tithin the fervid, unseemly world that was Industrial Bio-Test Laboratories, f w the place where things turned grueorr.e was a room they called the "Swamp." In .970. IBT's directors installed a Hoeltge autonatic watering system for one large animal eeding room midway through Number Three >uilding. Although it was designed to fill drinkng bottles and flush wastes from hundreds of odent cages, the equipment rarely worked roperly. Faulty nozzles sprayed the room with continuing chilly mist, showering the caged nimals. Water streamed off cages and racks, ubmerging the floor under a four-inch deep ool. Mice regularly drowned in their feeding -o' ~hs. Rats died of exposure. No technician jd the Swamp without rubber boots, and .any wore masks to protect themselves from \e hideous stench of disease and death. During the course of a two-year feeding :udy, involving more than 200 animals, the .ortality rate in the Swamp reached 80 per:nt. Worst of all was cleaning the cages. Dead :ts and mice, technicians later told federal vestigators, decomposed so rapidly in the vamp that their bodies oozed through wire ige bottoms and lay in purple puddles on the -opping trays. It was in conditions like these in the Swamp :d four other major animal feeding areas that T conducted thousands of critical research ith Schneider, a free-lance writer in Charton, South Carolina, writes frequently for the ami Herald, Baltimore Sun and New York nes. His report on recent efforts to silence ilic health scientists and administrators apired in the Fall '82 issue of The Amicus " Research for this article was made jft/.e by a grant from the Fund for Investiive Journalism. ecu* projects for nearly every major American chemical and drug manufacturer, dozens of for eign concerns, and several federal agencies as well. Nearly half of IBT's studies were used to support federal registrations of a mam moth array of products: insecticides, herbi cides, food additives,"chemicals for water treatment, cosmetics, pharmaceuticals, soaps and bleaches, even coloring for ice cream. One of the nation's oldest independent la boratories, during its last decade IBT was also the largest, performing more than 1,500 stud ies in its main facility in Northbrook, Illinois, twenty-five miles north of Chicago, and in two satellite laboratories in Neillsville, Wisconsin, and Decatur, Illinois. It has been estimated that between 35 and 40 percent of all toxicology tests in the country were conducted by IBT. Stjll, for all its prosperity and spurious prestige. IBT's business crumbled rapidly starting in 1976, when at the zenith of the lab's corporate strength, investigators fromthe U.S. Food and Drug AdminisIraitonTFDAT" uncovered what they allege is the most mas sive scientific fraud ever committed in the tJpited States, and perhaps the world! In May 1981, after a five-year joint FDAJustice Department probe, Dr. Joseph C. Calandra, IBT's president, and three of his top associates --Dr. Paul Wright, section head for rat toxicology; Dr. Moreno Keplinger, manager of toxicology; and James B. Plank, senior group leader for rat toxicology--were indicted in Chicago by a special federal grand jury. Each defendant is accused of eight counts of conducting and distributing fake scientific research, and then of attempting to cover up the scheme. After several postponements, the IBT trial is scheduled to begin April 4. Ifl convicted on all counts, each defendant facesl Oth: the; nay tr. t s:a; Chic tan: 7'PLAINTIFF'S EXHIBIT up to forty years in prison and fines totaling! over $40,000. TVe Amicus Journal Spring 19S3 15 25C5406S Within the lurid laboratories ofIBT, technicians quietly witnessed scientific accuracy fade away to a welter offorgery, trickery, and lies L'.S. attorneys in Chicago say the IBT pros that would pass registration standards at the ecution will be torturous. Calandra and the FDA and the U.S. Environmental Protection other defendants claim they are innocent, and Agency (EPA). Said one Justice Department in they have hired the Midwest's finest trial attor vestigator: "IBT became the largest testing lab neys to make their case. In the months since in the country, because companies knew this the indictment, the defendants have filed was the place to get the results they wanted." stacks of legal motions seeking dismissal of A primary example, prosecutors allege, is the charges. They insist that FDA and Justice the case of defendant Dr. Paul Wright. Before Department agents "harassed, abused, mis- ; he started work at IBT in March 1971, Wright led. bullied, intimidated and coerced" key i was employed as a toxicologist by Monsanto witnesses, in order to prove their case. Chief ! in St. Louis. Prosecutors say Wright went to FDA investigator Carlton Sharp is accused of IBT to manage Monsanto's contract to test the "abuse of the grand jury,'''because he know safety of TCC, the company's anti-bacterial ingly presented "false, misleading and in agent widely used in popular deodorant sprays. flammatory" statements during his two grand TCC was under suspicion by the FDA for caus jury appearances. ing testicular atrophy in laboratory rats fed the Similar tactics were employed by defense compound. At the same time, Monsanto was attorneys in two cases prosecuted several counting on TCC as a major product to replace years ago by U.S. attorneys in Chicago with hexachlorophene, another anti-bacterial chemi distressing results. In the first case, the gov cal just withdrawn from the American market. ernment gained an eleven-count indictment in Monsanto needed a "clean" IBT study to con 1977 against Velsicol Chemical for concealing vince FDA that TCC was safe so the agency key scientific results on the carcinogenicity of would grant them a registration to increase the the restricted insecticides chlordane and hepta- levels of TCC in deodorant soaps. chlor. The case was dismissed in 1979 on pro Wright stayed at IBT for eighteen months, cedural grounds. U.S. attorneys were turned to supervise most of the TCC research then away one more time in 1980 in a case against returned to Monsanto where he was named G.D. Searle, a major pharmaceutical manufac- j its manager of toxicology for its department turer, accused of falsifying scientific research. of medicine and environmental health. While In that case, Chicago prosecutors could not at Monsanto, according to prosecutors and gain an indictment. witnesses, Wright wrote several critical sec In the IBT case, however, the prosecutors tions of the final TCC summary report and successfully have answered each motion. Now pressured a key IBT scientist into changing that it is ready for trial, Frederick Branding, a his finding that TCC did, in fact, cause testicu former federal prosecutor who recently left the lar atrophy in laboratory rats. The sections Chicago office, calls it "one of the most impor Wright authored were included in IBT's sum tant cases ever investigated out of this office." mary report which was sent to the FDA. The agency eventually approved the new higher During the trial, which is expected to last levels in some deodorant soaps. Millions of at least six weeks, prosecutors hope not pounds more of TCC are now manufactured only to prove the defendants' guilt, but wiellach year by Monsanto as a result. also outline a pattern of chemical company IBT's test on TCC was just one of 22,000 knowledge of fraudulent research taking place toxicology studies the lab performed in the at IBT. They will also attempt to prove that quarter century it operated. Since late 1979, those practices were promoted by chemical pathologists at FDA, EPA, and in Canada and company executives in order to secure results Sweden, have undertaken an immense and 15 The Amicus Jclsmal Spring 1983 BFG60915 ,.iplex program of auditing IBT studies, hey have determined that more than 10.000 ere used to register products for the Ameriin market, and they consider nearly 2.000 as -irnary research. Most of these were for 325 secticides and herbicides. The vast major/ have been declared by American and Cana an scientists to be "invalid.'' Until recently, the details of the joint in stigation were untouchable as prosecuting tomeys. defendants, and witnesses declined comment pending the outcome of the case, ist December, however, as part of a motion to smiss made by Calar.dra's attorneys, almost 000 pages of secret grand jury testimony and lated documents were entered as testimony in c District Court, publicly revealing for the me the nauseating saga of IBT's demise. Most infuriating is the legacy left by IBT's andal. There are few Americans who do not ake daily contact with chemicals IBT tested .d declared "safe'' chiefly from pesticide resi les contained in their food and water. Since e scheme was first pinpointed, some of those emicals have been declared by federal agenes to be hazardous to human health and .vironment. Many others are accused by searchers across the country of causing illsses and environmental contamination. On this continent and in Europe, health thorities have begun to take regulatory :ion against chemicals registered with IBT ta. Sweden recently outlawed eight IBT sticides. Last year, after studying IBT data 113 pesticides, Canada outlawed six and merely restricted application of the fungicide otan. In the United States, the EPA's final mmary report on 212 pesticides registered `Ji IBT data is due to be released in May, rording to Kevin Keany, an official in the fee of Pesticide Programs (OPP). In other 1 the EPA has suspended the use of the .biu.de Silvex, and canceled most uses of the ectiddes toxaphene and DBCP, all of which j were registered with extensive IBT data. Still, j one thing is all toe clear: the magnitude of the | IBT scandal may never be known, and its effect is likely to carry on for generations. here is nothing remarkable in the way TFrontage Road runs alongside Interstate ! 94 in Northbrook. Like a hundred other two: lane industrialized corridors across America. I Frontage Road is home to a dull array of squat j motels, three-story corporate headquarters, ; and small manufacturing plants. It was here in 1953 that Joe Calandra estab lished IBT. Then a 35-year-old graduate of the Northwestern University School of Medicine, the young Calandra, according to colleagues, was a man of high sdentific standards who also knew how to make a dollar. Calandra could foresee that a toxicology lab which contracted its services was very much a growth business of the future. All signals pointed that way. The federal government was increasing the standards re quired for registration. Manufacturers, pressed to account for the safety of their products, needed firms to prepare the sdentific research. And Calandra, from the start, had a real prize for a client: the Pentagon. : Between 1953 and 1977, in an effort to dis cover better ways to preserve food for troops during war, the Pentagon paid IBT more than $8 million to carry out a long-term study in which irradiated beef was fed to mice and rats. The Pentagon was not the only U.S. agency to contract IBT's services. In the early 1970s, the National Institute of Drug Abuse spent $972,0000 on four long-term feeding studies, one of which was to test the toxirity of metha done. The FDA too was a dient. In 1974, the agency spent slightly more than $400,000 on four tests of their own. IBT grew quickly. Behind the first two administration buildings stood four nearly identical animal buildings, long and low, used Ut O X o ,sl BFG60916 The Amicus Journal Spring 1983 to housa : dogs, ar.c Throu: IBT's grfor its ser quickly ti areas of c good, thr Most im: A ashing", guarded, in the m: nually, er officers c $666.5 rr. facturer b Nalco bcu S4.5 milli- Backed a prograr. lab into .firm. Two 1970, com story rese. site. Calar. tant staff i was namt followed t group leac Paul Wrig and in Aug IBT's pad During, ring in W business E ment, ani tured by t President With the a cally more registratio of sdentin companies maintainir contracted IBT tho ness and *. was soon! than it cot . If they * slapstick c. 17 Still, f the way state tworica, quat :ers. stabf the rine. rues, who ould cted ness !eral 5 ressed jets, irch. )rize uis- x>ds han y in 'ats. :ncy 70s. sent ies. :hathe i on :wo -rly sed to house IBT's horde of rats. mice, guinea pigs. | The first time Manny Reyna, an animal techni dogs, ar.d chickens. i cian at IBT. was ordered out on a mouse hunt Throughout the 1950s and early 1960s, j he thought it was a joke. Armed with a plastic IBT's growth lagged far behind the demand | squeeze bottle filled with chloroform ar.d out for its services. The lab's reputation circulated : fitted in thick gloves ar.d a white lab coat. quickly through the science and development j Reyna joined a squad of technicians in a search- areas of corporate America. IBT's work was j and-descroy mission for rats and mice running good, they said. It was moderately priced. wild at IBT. Most importantly, it passed examination in Washington. While its finances were closely guarded, several estimates put IBT's revenues ; in the mid-1960s at close to 52 million an- j nuallv. enough to attract the attention of the j DBCP officers of Nalco Chemical (1931 revenues: j 5666.5 million), a specialty chemicals manu- j racturer based in Oak Brook, Dlinois. In 1966. | Soon after he was hired at 13T in May 1971, Nalco bought IBT from Caiandra for a reported Reyna realized that net all the rodents he 54.5 million. tendedj&nished their lives in cages. Every week, Backed by Nalco's millions, Caiandra began dozens of research mice and rats squeezed a program of expansion to turn his pioneering through the bent wires of IBT's mangled lab into America's largest chemical testing cages, raced across the long wooden racks and firm. Two smaller satellite labs were built. In dropped to the grimy floor to breed with wild 1970, construction began on a $2 million, four- rodents living behind tall stacks of animal bed story research building on the Frontage Road ! ding piled in the comers of the lab's feeding site. Caiandra was also making several impor rooms. During the night mice climbed back tant stair appointments. Dr. Moreno Keplinger up on the racks to feed on spilled fcod and was named manager of toxicology in 1970, feces, and they persisted in poking their snouts followed by James Plank's being named as through the bottom of cages. "For some reason, group leader of rat toxicology. In March 1971, I they would cannibalize the toes of the animals Paul Wright joined the staff from Monsanto, ; that were standing on the wire," Reyna testi- and in August, Dr. Donovan E. Gordon became 1 fied in his grand jury appearance. "In the mom- IBT's pathologist. ! ing we would see where the toes had been During the same period, events were occur ! chewed off. So. you know, we were at a loss as ring in Washington which turned a river of j to what to do.... It was a never-ending battle." business IBT's way. The environmental move The only temporary solution .was a mouse ment, an infant in the early 1960s, had ma hunt. For hours the armed squad would flush tured by the end of the decade, compelling rodents from cover and douse them as they President Nixon to establish the EPA in 1970. skittered past. "The animals were very wild,'' With the agency came publication of dramati Reyna testified. "They would run from humans. cally more stringent regulations for pesticide So our only'chance was to slow them down registration and use, requiring a broad range with the chloroform." Once snared, technicians of scientific studies. Though even the largest sacrificed their bounty, throwing the carcasses companies like Dow prided themselves in | into plastic bags, then tossing the mess onto maintaining laboratories of their own, they too trash heaps behind the animal buildings. contracted with IBT. Reyna had other choice stories for federal IBT thought it was ready for the new busi investigators. More than once, he said, rats on ness and welcomed all its new clients. But it two-year feeding studies were fed the wrong was soon in the position of having much more compound, something IBT never reported to than it could handle. its sponsors. Then there was the time the air If they were not so serious, the continuing conditioner in the brand new research build slapstick events at IBT might seem humorous. ing quit, and technicians hauled half a ton of 17 The Amicus Journal Spring 1983 BFG60917 25054068 o the third floor, setting up fans behind blocks to cool hundreds of animals housed mere. "It made a mess, and of course the temoerature didn't change but a degree or two." 1 On April 14. 1971, IBT began two Iong. term feeding studies for Chemagro's newest agriculture chemicals. The company hoped that Nemacur would compete with Dow and Reyna said. . Shell's popular soil fumigant DBCP. Sencor Occasionally, mouse hunts would get out of was a mulri-purpose herbicide. nand. During the course of the Pentagon's ; Chemagro's protocols for the two studies rradiated beef study. Reyna claimed the hunt ! called for feeding two groups of mice for eight oecame so enthusiastic that chloroform fumes een months. In addition, a control group would -tilled dozens of caged research mice. "I don't be established and fed a known animal carcino cow how many mice died that were on tests," gen. in order to make comparisons with the re ne said. "It was just amazing: it was a substan sults found in animals fed the test compounds. tia! number like 50." Was the test halted or On June 19, 1972, IBT sacrificed Chema- was its sponsor notified5 "No. the test con . gro's mice studies, fourteen months after they tinued." according to Reyna. "I think they just began. This was not reported to the company rilled in the gaps." until the summer of 1977_when IBT's testing Wherever Reyna looked there were follies activities had nearly come to a halt. to be witnessed. One of his responsibilities was In late July or early August. Philip Smith, ceeping track of frozen tissues which needed then a 25-year old technician at IBT, was to be stored in the main freezer upon arrival assigned by Dr. Wright to prepare the final from rBT's satellite labs. One day a panel truck summary report for the two studies. At the oacked up to IBT's receiving dock loaded with same rime, Wright handed Smith a completed | mortality table detailing the number of mice that had died and the dates of their deaths. It j showed that almost no mice died prematurely. ! Smith told the grand jury that he knew imme- I diateiy that the table had been faked. How? I Michael Black, the technician who tended to | the feeding study, had told Smith that the mor wenty-five or thirty boxes of frozen tissues, tality of the mice on Chemagro's tests had been -ater Reyna found out that Gerald Kennedy, a , enormous. In fact, Wright ordered 1,000 new ugh IBT official, had arranged with a meat i mice to take the place of mice that died during irocessor in Wisconsin to butcher hogs in- the test and specifically ordered Black not to olved in a skin bum test at the Neillsville report the addition in his records. Attorneys ab. "So he had all of this meat processed and for Monsanto said Wright would not comment ent to us evidently under the guise of being on these or any other allegations until the trial. ample tissue for a sponsor," Reyna told fed During the first week of August,' after Smith eral agents. "Meanwhile, I had to just about completed the reports, he was called into the rail that freezer door shut to keep it from pop- office of Moreno Keplinger where he learned >ing open. I mean that freezer was just packed." of another problem. Dr. Wright was waiting there too. Keplinger told Smith he was wor- he Justice Department's prosecution, j ried about the results from the control group rheaded by Deputy Chief of Special Pros- for the ChemagTO studies. So few mice had cutions Scott Lassar, involves fraudulent survived that the results from the control group esearch alleged to have been conducted on did not really demonstrate the animals' sus 3ur compounds: the insecticide Nemacur and ceptibility to developing cancer. ie herbicide Sencor produced by Chemagro, Keplinger said he was not going to report ow owned by Mobay Chemical; the drug the study. Instead, he had a solution. IBT had Naprosyn manufactured by Syntex to treat ar- iritis swelling; and Monsanto's anti-bacterial TCC. just completed a long-term mouse study for another company, and the control group for that study had been painted with benzidine. It did 3 TWe Amicus Journal Spring 1983 BFG60918 not mar: feeding linger s benzicir compare per rr.:'.'. to recal inser. :`r Or. A. to the : mor.ee had wi: immeci, Chem.ag ports. .rious o; lists of testified the mor him as' for the with FD did not: cate the have to that it w Thar at leas: next foi: number! inspecti-. and 137 IBT's rf officials were reg 1976. L and ask 1982,dt the EPA tory by! widely z One c ing its e maceuti *3 Califorz: develop- O hoped * InMa ers visit ON IBT's f: & signed z 19 ngest -4 v.or lies Jhtuld inoreids. mahey any -ing ith, was inal the :ted lice s. It ely. me- 3W? H- een lew -ing t to eys .ent ial. iith the ned ing voroup had oup 1US- )ort nad for hat did igp-> r.oc matter that Chemagro's protocol called for feeding benzidine to mice. Smith said. Kepiinger simply calculated that the amount of benzidine painted on the skins of the mice was comparable to a dietary level of 1.000 parts ! month rat feeding study, which included de tailed protocols for blood chemistry and urinalj ysis data to be recorded throughout the course | of the study and at the time of final sacrifice, j In November 1969, IBT began the study. In per million. Smith testified he was instructed ! September 1971. just twenty-two months later. to recalculate the control group figures and IBT sacrificed the Naprosyn rats. This was insert them into the Chemagro reports. On August 15, 1972. IBT mailed the reports not reported to Syntex until 1976, when the FDA alerted corporate officers. to the company. A year later. Smith was sum Once again. Phil Smith was assigned to moned to the office of Gerald Kennedy who write the final report. But in October, when he had worked at IBT since 1964 and was Smith's I began working on the blood and urine sections, immediate supervisor. Kennedy told Smith that I he could not find the data. He searched in the Chemagro was having trouble with their re ' animal department files and found nothing, ports. A Canadian regulatory agency, suspi j Then he went to the clinical pathology lab and cious of the results, wanted to see complete ! found a file containing blood and urine data lists of raw data for animal mortality. Smith through the fifteenth month of study, and a testified that Kennedy instructed him to use note which said the final blood and urine work the mortality table which Wright had given had been postponed. Smith tracked down Ron him as "gospel" in determining the numbers Greco, the manager of the lab, to find out what for the Canadians. Kennedy, in an interview it all meant. Greco was not sure. So the two with FDA agents in September 1980, said, "he men poured through the lab looking for the did not really tell Smith to go back and fabri cate the mortality table, but rather, it would have to remain internally consistent . . . and that it was up tq Smith to figure it out." That is precisely what Smith did. spending at least 60 percent of his time during the next four or five months formulating a cogent numbering system that would pass Canadian data, searching the freezer for serum samples, inspection. In December 1973, Smith finished scrutinizing scheduling records, looking in and IBT mailed its response to Chemagro. slide files and time charge records. Nothing. IBT's report was accepted by both Canadian When they were finished, the men "concluded officials and the EPA. Nemacur and Sencor j that the final blood and urine work had not were registered for use in the United States in been conducted." 1976. Later the EPA ruled the tests invalid During the next week, Smith completed a and asked Mobay to repeat them. In April hand-written rough draft of the report and left 1982, duplicate mouse studies were mailed to the data tables for the blood and urine tests the EPA, reviewed, and regarded as satisfac blank. Smith testified that he took the uncom tory by EPA toxicologists. Both chemicals are pleted report to Wright's office, told him the widely applied across the country. tests had not been done, and said he would One of the companies attracted to IBT dur not sign the report. ing its expansion period was Syntex, a phar maceutical manufacturer based in Palo Alto, California. In the late 1960s, Syntex scientists developed a drug called Naprosyn which they t was standard procedure at IBT for those Iwhose names appeared on the signature pages of final reports to receive copies in the hoped would revolutionize arthritis treatment. company mail. So it is not hard to imagine In March 1969, a small group of Syntex lead Smith's surprise when he received the Napro ers visited Calandra in Northbrook and toured syn report, opened it to the summary tables IBT's facilities. Several months later they for b^ood and urine data and "saw that the val signed a contract with IBT for a twenty-four ues were reported for these tests." Then he 19 Tkt Amicus Jouk.sal Spring 1983 25C54070 BFG60919 BT Approved Pesticides eral legal uses, including dipping cattle and sheep into vats of toxaphene for parasite control. Services, in an evaluation of 2.4-D. concluded in a published report that exposure to the her SILVEX -- A member of the bicide through skin absorption controversial phenoxy herbicide could cause nervous system dis The aftermath of the Industrial family developed in 1943 at For: orders. The EPA has taken no Bio-Test Laboratories' ordeal Detrick. Maryland, for possible action to limit the use of 2,4-D, reaches deep into the lives of use in chemical and biological and Dow. along with several most Americans. Residues from warfare. Silvex has been a tar other manufacturers, is promot hundreds of pesticides tested get of environmentalists for dec ing more extensive uses, par for safety by IBT appear in ades. In the West, indiscriminant ticularly in aquatic weed control. measurable quantities in virtu use of Silvex is believed to be CAPTAN -- First produced in ally everything Americans eat the cause of widespread stream 1951. captan is an effective fun ar.d much of what they drink. contamination and the loss of gicide used in treating seeds, These pesticides have contami livestock. In Florida, a recent on greenhouse plants, and con nated groundwater supplies and Florida State University study tained in chemicals for house- reservoirs, polluted streams and found Silvex in trace amounts . hold use. The'chemical's two rivers, and have been implicated inthe' tissue of a third of all ` major;manufacturers, Chevron ...in a host of serious health prob-': ., dormitory students and one quar. leihs. What followsis a partial ' ' to- of the football team. In 1979, -and Stauffer Chemical, produce: van estimated 10 million pounds r?1 list of widely applied pesticides, the EPA abrubtly suspended all each year. IBT prepared twelve, declared by IBT researchers.to .uses of Silvex in the Northwest. studies on captan for Chevron, ' be'nonhazardous. though subset 'But Silvex continues to be used :all of which have "been`ruled quent studies by the EPA, Cana- hi preparing rice fields, weed invalid.'In addition,' Canadian' - ' dian health authorities, state control in sugar cane planting, " health authorities secured five'. . health agencies, and independent. and for range and pasture use. . internal memos which indicated researchers have raised doubts. 2,4-D --Contained in the Viet- several summary.pages of IBT:; .TOXAPHENE -- Like DDT. al- nam-era defoliants Agent White captan reports, were rewritten^ ' '-in. and_dieldrinTwhich have arid Agent Orange,' some 70 to ' after Chevron company officials J en bafined.by the'EPA), toxa/ ' .CBOjiifllion pounds of this phen- ' /cbmplained/about.' the number/ phene is amernberof the deadly-.-, ^oxy Herbicide are sprayed each "r /of .mutations 'IBT* pathologists';; -chlorinated"hydrocarbon family year'on vast stretches of forest . /found m the;.testsFRecen'f Cana/.; _of insecticides. First produced in - and for roadside weed control.- /dian' studiesihow ciptan causes E 1947, during much of its produc-' ^T performed at least six stud i`cancer, birth'defectsrand genetic".-'; tion life toxaphene was among ies on 2.4-D which have proved damage in laboratory animals, fhe_nation's most popular pest tohe'invalid after IBT officials, `- and Cana'da's health and welfare./ . killers. In the mid-1970s, more .in 1977, shredded the raw data /department-severly' restricted .than 100 million-pounds of the'" "the lab had stored for the chem- `.captah's'use .there Last year. In. f '^compound -were prod uced..an- .vicars/manufacturers.. Though r.this country, captan has been on/ IBT declaring toxaphen'eliarm-y': vlessl'But nfa.979, -fheT^ational / '.v-^TTaismsaif-Sdaesrmtecn'h"ecm.hcia_c_rag_lestdevbe'yr^--menavdireo/n:it-/- '^Jbeh^tan~a-nsJanalyaslismh^ -Canc^JInstitute (NQj finished 1 Jiraentalists Hnd sdentists'withUTi^Jerway aFEPAjyJntil it'isjcom-5 -a two-year rodent feeding study. which found toxaphene caused ^causing fetal deformities and ymiscamages where its use_ is .-i^Ietedriagehcyrbfficials^say no^.'w-VT-."' /regulatory action will be taken.- . liver cancer in'male and female - jheaviest Independent research- l-againstcaptan./tic;.. rats. In more recent studies bv J YhasTdetermined that'7.4-D is ~/-'DBCP --;'In'th'e/summer of./ the. EPA,:dangerous levels`of~ .incapable, of inducing^mutations/'3.962,^IBT'.'produced -severala -.toxaphen_e__"were ".d.iscovered i,,n -.-: JinJaboratory" mice even at the/ 'i/s&dies'forShellChetnicaltotesf^ the tissueibf fresh-water fish Uv^^ldw^dosdlevels'.-Moreover;' at: .^^et^j^ie^fi'^iriuds.iahl'>x:* -,ing m'Jakes^and.' streams'thdu:'jj ^DeparbiienEof .Health,- Edtidijf jSrspmvel^^oses^bf DBCPJ sands bf'miles from thelclosest.; -c<tinnr5rv4- WoifTrS *r irri-fV,'.-.nti:>#,..cm2,* point of application. .In r0cto-' iber'1982; ;th'el EPA - canceled ;jj$rocluced terafogeiilti e ^EPA fesearchiS^^e IBTistii^, most' uses .of toxaphene.-The'_ Aeds^ton^ocjnorefhianSna^T Sies snowe^DBCI^Jo.be^.Iws^ comical's major manufacturers," lianispedesrand its'-ose should gh/will.be'allowed to sell :.- ..be.restricted."T-inan"1*- ^ - uicir-Tl" 2a"wide /pets. =fjtjons r -gguinea -v-eral ye /y//: VAgenci HsM ^(lARCi iryfoundi BFG60920 f\ i; I J . V". .v j V ' *J 4," .. 4 ' `.r:^MJ ^1 ,- ;. * -' *^.V 7-w - ' . -. J. VT.'.?*;, * - . ^ ; W*''**..".-<,*c-?-. --.j* * r.v cause of sterility ih'male Workers ' 'r1980;' EPA'S Edwin L: Johnson.'' currently studying new'data on at a Occidental Chemical plant- -director of the Office-of Pesri-;.. yHarvade and is considering a .in.. Lathrop^ California. Califor-_L tide Programs. surprised agency ^ full reevahiation of the herbi' ruV health: `offidaTs. who" Tound^ ."saenrists. and ignited aun'.inte'r-. . .ade's registration there '' dangerbusTy.high levels "of the" 'n"al furor. w~hen he halted EPA"s rj diemTcariiTgroundwater miles'' - plan; to remove carbaryl;from' from the plant, suspended the", - the 'market. Johnson V:.~.'conuse of DBCP in the sta:eTthe.' ' "eluded that the "overall weight" same year.;.Though Shell and . of evidence does not indicate ; . In Canada, manufacturers of ' 113 IBT pesdddes'.were asked ' to duplicate the research or face' cancellation .of theirr products.' the Dow Chemical manufactured-.. ..that risk criteria have, been met Makers of three herbiddes and roughly. 20-_milliori pcuhds-.ofa_ ", oPexceeded."- Around the na; ; .three msecriddes chose not to. 'DBCP^anriually/chiefly" for:use - h'tion; where carbaryl use is heavy" -and Canada removed those prod-; in bricKkrds as a soil fumigant to"'; 'critics.' 'are. not' so,sure.': Says Jiicts^from _the marketplace last k.iir tiny'.worms that fed" onrroot'T fOirRuth.* Shearer.. arwidely-' re-^l -r yean'.Those chemicals are: systems; both comparues-volun-:" vfspected.geneticist from fss'ac', [- r^ALLrDOCHLOR -4- A Mon-; tarily'suspended production of ""quah',. Washington: "In my o'pin-' ! . sahto herbidde used iri'clearing" DBCP. In 1978. a two-year, car '/ionjcarbaryl presents a definite- 'weeds from onion Celds. cinogenicity study undertaken'. -4'risk: to. human health if applied . CHLORJBRONfURON - An- by Lhe NCI cor.duded that DBCP.: . .-in.-.'residenria] area's or .'other;. 'lother herbicide manufactured' Was a:powerful stomach carrinoi- Scares '^by'the Swiss firm Giba-Geigy;: gerriri'rnice and"rats fed DBCPiv anctalsojprixluced bribas^canjl -?an(fused in carrot fields. . ..rtiyA' herbidde 4 ;c^uyrafefed the compollndiA^ , . .vr- -- line^ i-yeaf/Jatecfthe' EPA cancelecT aD -usesof DBCP, s*lve fQl] Hiwiii'a^ ; pineapple'crop.v'r'' ^ofweed killers animitTawed for j ^use.'ui'Canadian corn fields. . f^-PHOSPHAMIDON-'.- A| `^CARBARYL--A member'of4 -;'"Ciba:Geigy- "msecddde-sold by'? tbexarbamate family of ihsectf^r ^ensed/iof'causing.hundreds'of ' Chevron inVCanada and Calir-. ddes,' carbaryl was one cf nine-;:, S' severe'; respirator' disorders: '-'foriiia. ,"i -* teen dhemicals'rited in-ar.Iapd--.y i- around the.nation as its use in.. -;::^'BIANAPACRYL--Manufac-4 mark' HEW report in_l6_9;an'<ic iiU.SI nurseries' and in marijuana 4 -.aernsedofcausing cardnogenicj; -i'orn^wrihVin prirTfl^coc" -.r* ctured byi'^the'..German rJHoechst as a mitaade: ftrm;! " ` tumoTS, huth defects, an&otftetjj serious health-problems^TReri _________ :;-DIALLIPHOS -- Another''- .. j , ,(. . iViet?. rt mitaade manufactured by a su HEW4 commission wTotelthatu: ^anvera'defolIan^Agen'b! Blue^ ^sT4iary of lfecuI^Cherrical. -;'i .carbaryi"should be immediately- :yacbdvlic. add pfoductfon.S.m-^ restricted to prevent risk: ofhu-^ ^CTe'a^g/as-'.timber.co'mpanfes"', .;'r'V^V:'. Schnieder.. marr e.xposure.". Manufactured^' irtnqve'to replace Silver and'the"" by Union Carbide since.T958; -.'Toutlawed herbicide'2.<t: 5-T,,:a .' nearly a_b01ion pounds of car-;- ^edmponentrof Agent OrangeITi:;: baryl-have been sold, about half-; t&c^PERMETHRIN--Though it; overseas. In the United States, ' . jhas yet: to recefve'fuU registra.-"- use.now'averages an estimated... t-tidn from the EPA, this insecti-, 60 million; pounds annually foi: .rtT - 'r^r- * - ' e- t m tr* / J- ar.wide'nmge of acmvitfes^ uPT: &eluding"'some brands of flea'cbl-I. 'lars^sprays and powders fori' ^AdramG_rSs;'cdbemgaf2rTdri^ - pets;-and.jn spraying for gypsy;: i^ogenilCurrently, peTmefinin has';. 'zx'r-iv * iV- moth infestations from Maine to;. >a.''conditionaI registration :and - Maryland. Carbaryl his been' :- millions of pounds are supplied targeted by researchers as a to applicators under the EPA's danger to human health and the 'controversial "emergency ex- environment chiefly because of *: empdon" dause. .; . its proven ability to cause muta >:'HARVAJDE --Uniroyal's dis- tions'in'the fetuses of.dogs,, ;-puted cotton defoliant was re- giiirieafpigs, and rabbits. Sev-; T^cently"discovered by California eraT years ago. the International"' ^officials' to be a potential car- Agency for Research on Cancer ' anogen. Lori Johnson, chief of (IARCV studied carbaryl and the California Agriculture De found it to be a carcinogen. In partment's pesddde division, is 21 - ' The Amkus Joui-VAL Spring 1983 ZLQ hSQ S Z BFG60921 .ed to the signature page and was shocked u see his name written in. Things got even granger a few days later when Smith's rough iraft was returned from IBT's typing pool, -le turned to the blood and urine summary ables and discovered they were filled in by vhat Smith "recognized as Mr. Plank's hand writing and some [data] in what I recognized is Dr. Wright's handwriting." NAPROSYN In an interview with FDA agents in May 980, James Plank "denied that he knowingly nserted false information in this report when ;e prepared it." Plank did identify his hand writing from the rough draft and said he pre pared some of the tables. But Plank advised he FDA that he was sharing an office with Vright at the time and "he was often given sports to plug in the data by Dr. Wright." e numbers juggling, however, did not v-^ry Syntex. In mid-November 1971, two .-eeks after IBT mailed the Naprosyn report 3 Palo Alto, Dr. Robert Hill, a Syntex toxicolgist fired off a letter of reprimand to Calandra. From past experience I am convinced that the sport would be rejected by regulatory agenies in the United States, United Kingdom, anada, and Germany," Hill wrote. "Would you lease see the report is corrected and returned t the earliest." To revise the report, Keplinger asked EBT's athologist, Donovan Gordon, to evaluate stomch tissues taken from the Naprosyn group, 'hrough his microscope. Gordon saw lesions a the tissues caused by anemia and which he included were "induced by the drug." To suport his findings, he wanted to look at the raw iocd and urine data. He called Dr. James Von ruska, supervisor for the Clinical Pathology ab.and asked him to send the data over. After another thorough search of the patholgy lab, Von Druska called Gordon and told .m the data could not be located. As a result, -ordon referred to the numbers published in inal Naprosyn report, and when he saw iai -a the values appeared normal, he revised his conclusion, stating that the animals died of lesions common to the stomachs of lab rats Meanwhile, back at the clinical pathology lab. enough questions had been asked about the missing data that Von Druska consulted with Gordon, telling him it appeared the work had not been done, yet the numbers appeared in the report. The two men decided to bring the problem to Moreno Keplinger. Dr. Keplinger did not seem overly concerned. i Gordon told the grand jury. He listened briefly to the men who had come to his office, and then waved them out. 'Til take care of it." i Keplinger said. In early 1972, IBT revised the Naprosyn report for Syntex and included an appendix detailing Gordon's tissue findings. They mailed the package on March 3. 1972. Three weeks later Syntex mailed the reports to the FDA, and were granted a registration soon after. Syntex has repeated the rat feeding study, and Naprosyn is currently one of the company's major sellers. In early June 1971, two months after he ; arrived at IBT, Paul Wright called Phil Smith into his office. He told Smith IBT was starting four new long-term rat feeding studies, one of which Smith later learned was for Monsanto's TCC. The study protocol called for feeding low, medium, and high doses of the compounds to 210 individually caged fats housed in the Swamp. In addition, a large control group would be "gang-caged" in the room across the hall from the Swamp. Almost from the start, the TCC study was a disaster. IBT technicians used a curious acro nym on internal mortality sheets when they found dead rats in their cages. In the column next to the rats' cage number, they would mark "TBD/TDA." It meant "too badly decomposed/ technician destroyed animal." Under ideal lab conditions, the most critical factor in chronic feeding studies is to find out why animals died. Was the test compound responsible? Or was there some other reason? TkE Amictjs joutMAi. Spring 1983 In Only care: logical ey cause of cmonplace from the; TCC rese. ii nym, T8: internal s: Manny * - the condi r' Swamp th. f . odorous c ' problem." little that -T- . It is als mony tha '7 ri .* .* r Plank we: Swamp. Ithe room ' Plank's ic Still, for a was built, \f- _ dozens of while it v- h* .- . Eight ir ary or Ma . *. * . prepare a handed Sc > incredukx mg the st: At abot name of Swamp individual mals gan: 10 expressly 8 __ switch. P: T: * - from a si group of .v.- - study" gr I'h-- dead anir One of identified r June 197. - . .. 23 v >- BFG60922 mt . and ; iny's - r he mith ting :e of ito's ring mds the oup the as a crohey :mn .ark ed/ ical out and on? 981 In the column next to the rat's cage number, they would mark "TBD/TDA."It meant "too badly decomposed/technician destroyed animal." Only careful autopsies and microscopic patho logical evaluation could determine the true cause of death. But dead animals were so com monplace at IBT, that most were simply taken from their cages and thrown away without examination. Within weeks of the start of the TCC research in the Swamp, the familiar acro nym, TBD/TDA. began appearing all over the internal summary sheets. Manny Reyna was concerned enough about the conditions of the TCC animals in the Swamp that he alerted Paul Wright to the mal odorous catastophe, "He acknowledged the problem," Reyna testified, "and said there was little that could be done." It is also clear from the grand jury testi mony that Calandra, Keplinger, and James Plank were also aware of the conditions in the Swamp. In fact. Calandra was known to call the room "Plank's Folly." because it had been Plank's idea to'install the watering system. Still, for at least three years after the system was built, according to grand jury documents, dozens of tests were conducted in the Swamp while it remained a turgid den of death. Eight months into the TCC study, in Febru ary or March 1972, Wright assigned Smith to prepare a six-month status report. Wright also handed Smith summary mortality tables which incredulously reported no animal deaths dur ing the study's first six months. At about the same time, a technician by the name of David Penner who worked in the Swamp was told by Wright to replace dead individually-caged rats in the Swamp with ani mals gang-caged across the hall. Penner was expressly forbidden to make reports of the switch. Penner was also told to order new rats from a supply house and to start an extra group of animals, later named the "research study" group, which would be used to replace dead animals. One of the organs for TCC that FDA had identified were the testicles of male rats. In June 1972, a year after the TCC study had I : i i ; begun, pathologist Gordon began the first in a series of microscopic examinations of testicu lar tissues taken from some sacrificed rats. Gordon's first evaluation from the highest dose males revealed that TCC did cause testic ular lesions. When he reported the finding to Wright, Gordon was told to take tissues from medium-and low-dose group males as well. During the next few months. Gordon found degenerative changes in these groups, but con cluded that lesions in the low-dose group were not related to TCC. If Monsanto and Wright drew a breath of relief, Gordon was never aware of it. The fol lowing November, Monsanto would be meet ing with a FDA panel studying TCC to talk about TCC's safety. Company officials wanted to make certain that Gordon, who would also be at the meeting, would back them up. So on October 11, 1972, a few days after Wright left IBT. Gordon was summoned to a meeting in Des Plaines, Illinois, to discuss TCC with Dan Roman and Ira Hill, two Monsanto scientists. They grilled Gordon about his TCC findings, and instructed him on how important it was to emphasize "a good presentation" to the FDA panel on TCC. On November 13. Gordon was accompanied by Hill and Roman to FDA headquarters in Rockville, Maryland. On the plane, they again discussed Gordon's presentation. Once there, Gordon performed to their expectation. Min utes of the meeting record that the pathologist never mentioned the treatment-related effects he had found. AT IBT, during the same period, Gerald Kennedy replaced Wright as section head for rat toxicology. Within days of his appointment, Manny Reyna briefed Kennedy on all the problems technicians were having with the TCC study. Rats in the Swamp were dying in droves. Kennedy was not surprised, but he was concerned enough to bring the matter to Moreno Keplinger's attention. The men toured the Swamp, and Kennedy testified that "on at 23 The Amicus Jour-nal Spring 1983 25054074 BFG60923 : one occasion" Calandra joined Kennedy ... a tour of the Swamp. When the TCC animals were sacrificed in fuly 1973. Kennedy was assigned to write the final report. Kennedy looked at the raw data -ables and decided they were a hopeless mess. He told Keplinger "the study would be impos sible to report without disclosing all of its nadequacies." Keplinger "clearly understood ind acknowledged" Kennedy's dilemma, but old him to emphasize Gordon's pathology findngs and to "downplay the study organization, mimal disposition, and mortality." On October 6. 1973, Calandra, Keplinger, rnd Kennedy met with Paul Wright, now back vith Monsanto. Wright had been responsible or the TCC study for its first fourteen or fifeen months, Kennedy testified, and was well iware of the problems of the Swamp. Kennedy ilso told the grand jury that after Wright left BT. "he and Dr. Keplinger had kept in con stant contact while the study was being run." HARVADE The meeting lasted for hours. Of particular oncem was Gordon's findings, reported in preliminary report, that testicular lesions aused by TCC were found in rats fed large nd small doses of the compound. Wright was xtremely upset with the findings. He told the toup that age, nutrition, the conditions of the ats, and stress could account for the effect, nd he urged Calandra and Keplinger to conince Gordon to change his conclusions. Between October and February, Kennedy, ssisted by Keplinger and Gordon, worked on ie final report which was mailed to Monsanto n March 21.1974. There was no further word oout it until October 10, 1974, when Wright Tote to Keplinger requesting the pathology ata and tissues for rats fed the lowest doses. In late December or early January 1975, alandra called a staff meeting to discuss the CC study. It was attended by Keplinger, -ordon, Jim Plank, Kennedy, and Dr. Florence - hita, a toxicologist who joined IBT's staff ptember 1973. Just the year before Dr. j Kinoshita had been a member of the FDA ! panel investigating the compound's effect on ! laboratory animals. ' When all the participants entered the room, : Calandra raised the TCC final report over his head, slammed it down on the table and said, "This thing isn't worth the paper it was printed on." Calandra then launched a long discussion of the report. "Dr. Calandra was extremely | concerned." Kennedy said. "He did not want | to admit to the FDA that the study report could not be substantiated by the raw data. i.e. the study organization was false, the mortalitytable was false, the purpose and use of the so-called research animals was false, etc." It was decided that Dr. KinosEita was to prepare a revision of the TCC records. Still, the most important conflict in the study continued to be Gordon's findings. On Janu ary 22. 1975, Paul Wright and Dan Roman returned to IBT for another meeting with Calan dra, Keplinger, Plank, Gordon, and Kennedy. Again, Gordon's conclusions were criticized as unfounded. A month later, on February 21, 1975, virtually the same group convened again at IBT and again the same problems were discussed. By this time Kinoshita had com pleted her revision, and it was handed to the Monsanto staff members before they left IBT. i Monsanto continued to be dissatisfied with j the pathology sections. On August 25, 1975, Calandra directed Dr. Gordon to meet with Dr. William Ribelin, an independent pathologist hired by Monsanto to review the tissue slides, in Madison, Wisconsin. Gordon knew Ribelin and the two scientists agreed to meet alone for lunch before convening with Wright and an other Monsanto official in an afternoon meeting. Over lunch, Ribelin and Gordon compared notes on the TCC tissues and agreed that "there was a treatment related effect involv ing all three treatment groups," Gordon said Ribelin also gave Gordon a handwritten copy of his report for Monsanto in which he stated his conclusions, and cautioned Gordon to keep the report secret Later in the day, the scien tists met with Wright and told him that testicu lar lesions in all three dose groups were caused by TCC. Finally, in late January 1976, Calandra called Gordon into his office to discuss the lesions. Thz Amicus JoumAi. Spring 19&3 BFG60924 Like Wright. CaJandra tried to convince Gor don that the lesions could be explained instead as manifestations of age or stress or the con dition of the rats during the study. Gordon did not agree. Then CaJandra hit him with a last solution. He asked Gordon if there had been significant decomposition in the rats he studied? Gordon answered that in some ani mals there had been decomposition but in others there was very little. CaJandra paused a moment and then told Gordon that he was going to remove the pathologist's findings from the report and say instead that decomposition "precluded meaningful evaluation of the tes ticular tissues." In short, IBT would report that the tissues could not be examined, because the tissues had rotted. "It was my opinion at that time, and is today, that postmortem data were removed from the report, because they incriminated the TCC compound," Gordon told the grand jury. CARBARYL On Februrary 3, 1976, Gordon was called to Calandra's office for a showdown. Waiting for him there were Keplinger and Kinoshita. They handed him a copy of the TCC final report, now in its second revision. Calandra told him to sign it and Gordon complied. "I did net want to leave IBT at that time, so I suc cumbed to my boss's interpretation . . . even though I knew he had not examined the slides," Gordon said. The next day, according to Kinoshita's grand jury testimony, Dan Roman hand-delivered a revision to the pathology section "written by Dr. Wright." In substance, the revisions stated that there were no lesions found on male rats fed the lowest doses of TCC and that some pathology review was prevented by decompo sition. Kinoshita and Keplinger stayed with Roman in the administration building confer ence room while they waited for Wright's revi sion to be typed into the final report. On May 10, 1976, IBT mailed the TCC report to Monsanto. It had been backdated to March 21. 1974, to appear as though there I 25 had been no changes. On May 11. Monsanto mailed the report to the FDA. The agency eventually approved higher levels of TCC in deodorant soap. Millions of pounds of the chemical are manufactured annually, though Monsanto insists a person would have to eat two dozen bars of Dial soap every day for years to be in danger of a toxic reaction to TCC. r. Adrian Gross, then a pathologist with Dthe FDA, was the first to put his finger on IBT in April. 1976. Several writers have described the event as a matter of chance, but that is only part of the story. Nine months earlier. Senator Edward M. Kennedy began the first of a series of historic and sensational hear ings on Capitol Hill in which it was publicly disclosed that scientific research being con ducted by the nation's drug industry was being deliberately falsified. The following January, officials of the EPA admitted that they were finding evidence of the same kind of shoddy scientific research in their files. It was in this atmosphere that Gross initiated a program of random spot checks of recent testing reports submitted by manufacturers to the FDA. One of the reports pulled from the files was EBT's Naprosyn study. As soon as Gross looked at the mortality tables, he suspected something was wrong. "None of the rats had developed cancer," Gross said in a recent interview. "Now, any patholo gist knows that rats and mice on these long term studies develop cancer naturally and will have a certain level of mortality. IBT's study said the rats were all clean." With one of the government's best and most tenacious pathologists on the case, IBT's *. scheme unraveled quickly. On April 11, 1976, Jr Gross made his first visit to IBT to look at the q raw data for the Naprosyn report He returned on July 12. During these visits Gross saw for the first time IBT's use of the TBD/TDA aeronym. He also saw that rats listed as dead in^ The Amicus Jourxal. Spring 1983 one section of the study, suddenly reappeared alive in another section. "Now IBT did some strange and unusual things," Gross says, "but bringing back the dead wasn't one of them." Gross's first visit set off a near panic at IBT. A week after he left. Calandra called a staff meeting in which fourteen employees were present. He notified them of the visit, and announced formation of an IBT audit gTOup to research raw data on several studies. His plan was to minimize the damage, confine the FDA's investigation to a few specific studies, and emerge at the end with his lab's reputation and its lucrative business intact. By 1976, according to New York Stock Exchange reports filed by Nalco, IBT had revenues exceeding $9.5 million annually. But Calandra's plan did not work. Not only was the FDA interested in Naprosyn, it also began probing the TCC study and several oth ers prepared for an array of manufacturers. The EPA was notified, and it began pulling IBT studies and noticing faults. By the end of the summer Calandra and his staff were shuttling between Chicago and Washington for intensive meetings with the FDA. BIANAPACRYL Convinced that Calandra was not going to . cooperate, the FDA began making plans for a criminal prosecution. To insure that the prose cution would be successful, the agency needed to secure IBT's internal documents. The FDA has no subpeona power, so in 1977 it turned the case over to the Justice Department. In a January 5,1977, memo to his superiors, Adrian Gross warned them to act fast. He was wor ried that IBT would destroy incriminating evidence. "I believe immediate action on our part is indicated," Gross wrote. But IBT already had begun a program of shredding data, according to Gross and other investigators. Much of the raw data for rBT's studies on the herbicide 2,4-D was destroyed, 'eral agents say. And data for at least six 26 _ ... other pesticides is missing. Moreover, agents are convinced that hundreds of letters between Calandra and company officials showing chem ical company knowledge of IBT's fraud were also destroyed. Nevertheless, many suggestive leads remained when the Justice Department finally seized 30,000 IBT documents. Through the years, six corporations have sued IBT and Nalco for breach of contract. All have settled out of court, and as part of the settlement the amount of dollar damages has remained secret. A seventh suit, brought by shareholders of Syntex, claiming significant losses when the FDA's investigation was an nounced and Syntex stock plummeted, was won by the plaintiff in U.S. District Court in New York. Paid damages against IBT, Nalco and Syntex amounted to $2.8 million. Joseph Calandra stepped down as IBT's president in March 1977. He still lives in the Chicago area and teaches pathology as a full professor at the Northwestern University School of Medicine. Paul Wright continues to work for Monsanto. James Plank left IBT a month after Calandra and is living in the Buf falo area. Moreno Keplinger left IBT and, according tq.his attorney, is working as a con sultant in the Chicago area. As for EBT, there are nine people still work ing at the Frontage Road site, validating re search for former clients who may still have questions. One of them is Donovan Gordon. The satellite labs have been sold, and the main lab is on the market. Asking price: $2.7 million. The rats have been shipped out and the Swamp is just a room with a concrete floor. Looking at ffiT now, it appears as torpid as any other building on the street. Then the images come rushing back--rats in puddles, mice drowning, filthy animal rooms--and with them a realiza tion that what occurred here was worse than we may ever know. A to Integ by Me The h cotton San Jc lions s team c niausi came bugs v The Andre- at U.C Contro are go would early k increa- buddir. This researc grated cut the saving Desp pestitic thirty y double; outbre; mies. C nated taken r 1 on a tr-: for pes V\ as pesr & ral prec O Ni Twer. Spring indiscri Mary E Felton, . "Hri Amicus Joukkal Spring 1983 27 ...... ' BFG60926