Document 93DwvE262ONB9pgjQ3m7nY22V

.If HC-F,: ^'c'-iS: ? iiu-cnanc, 13ary .'L ar.2ej,s=ri,. - own. - - "The co^nieni; summarises rile V;r.y1 Glorias decis: EFATs rscant benzene and rails reel ides p race sal; reviawe the response ct snvir:mentailsts and i: la EPA's proposed upp ras zhes . and r i. a a 11 y .= r,= Ly; areas table risk derisions sic ..Id is r.ei - for re: .s la safaris , 'r ' .^. -- . z Ksu-aSTwI r^e .sources ^aranse unci^ v.. Stvironmartai Prsiscticr .-.reacy DEJECT: Risk-- FXJ. S. ] r--a- JBJECT i Vinyl deride-- fir. 5. 3 -- legal cases <3fJl^3 J.-m :nn "EJECT: He7z. =aTr\-f 03 substances--- f TJ. S. bJiCT: U13- Environmental Protection Agency EJECTi NAMEi ATION: Natural Resources Defense Council. Inc. v. Environmental Protection Agency Harvard environmental law review 13: 535 - Press'KEEP or see'staff LRS89-3525 " United States , J* 'I C f i < C c c c Laboratories, URGE: .Amices journal, v. 4. spring 1983: 14:-2 5.' THOR: i schneiaer. EezTth. " CCE3:\Describes how the FDA uncovered massive scientific fraud 's \t ^INDUS'H&SL 31Q*-*TEST* Laboratories which "conducted \ ino^sarttfs of critical research projects for nearly ivsry najer American chemical and drug manufacturer, dozens of foreign concerns, and several federal agencies as well. Nearhy^half of 1ST'3 studies were used to support , federajT^s^cistrations of a mammoth array c: products^ in.secticidab>-h^rbicides. _ food additives, chemiunJr^ror water treatment reosrrsrstiCti Ts^. ghajjaarcauticaTTfr scads bleaches, even colorin.ngg for Icenrream.n r~T> ECT: Laboratories--[Illinois]--Evaluation ECT: Science and ethics--[U.S. ] : rauu---- ^ TJ. 5.1 :CT: Labcratory animals--[U.S.1 CT: Chemical *INDUSTRIES* --[U-S-1 :CT: Pesticides--ru.s.3 (O rp _ c c c * c faking It The Case Against Industrial Bio-Test Laboratories by Keith Schneider ithin the fervid, unseemly world that projects for nearly every major American Wwas Industrial Bio-Test Laboratories, chemical and drug manufacturer, dozens of for the place where things turned grue eign concerns, and several federal agencies as some was a room they called the "Swamp."wInell. Nearly half of IBT's studies were used 1970, IBT's directors installed a Hoeltge auto to support federal registrations of a mam matic watering system for one large animal moth array of products: insecticides, herbi feeding room midway through Number Three cides, food additives,"chemicals for water building. Although it was designed to fill drink treatment, cosmetics, pharmaceuticals, soaps ing bottles and flush wastes from hundreds of and bleaches, even coloring for ice cream. rodent cages, the equipment rarely worked One of the nation's oldest independent la properly. Faulty nozzles sprayed the room with boratories, during its last decade IBT was also a continuing chilly mist, showering the caged the largest, performing more than 1,500 stud animals. Wafer streamed off cages and racks, ies in its main facility in Northbrook, Illinois, submerging the floor under a four-inch deep twenty-five miles north of Chicago, and in two pooh Mice regularly drowned in their feeding satellite laboratories in Neillsville, Wisconsin, troughs. Rats died of exposure. No technician and Decatur, Illinois. It has been estimated that ered the Swamp without rubber boots, and ny wore masks to protect themselves from the hideous stench of disease and death. between 35 and 40 percent of all toxicology tests in the country were conducted by IBT. Still, for allots prosperity and spurious During the course of a two-year feeding prestige, IBT's business crumbled rapidly study, involving more than 200 animals, the starting in 1976, when at the zenith erf the mortality rate in the Swamp reached SO per lab's corporate strength, investigators from the cent. Worst of all was cleaning the cages. Dead U.S. Food and Drug Administraiton (FDA) rats and mice, technicians later told federal uncovered what they allege is the most mas investigators, decomposed so rapidly in the sive scientific fraud ever committed in the Swamp that their bodies oozed through wire United States, and perhaps the world. cage bottoms and lay in purple.puddles on the In May 1981, after a five-year joint FDA- dropping trays. Justice Department probe. Dr. Joseph C. Calan- It was in conditions like these in the Swamp dra, IBT's president, and three of his top and four other major animal feeding areas that associates--Dr. Paul Wright, section head for IBT conducted thousands of critical research rat toxicology; Dr. Moreno Keplinger, manager of toxicology; and James B. Plank, senior group leader for rat toxicology--were indicted Keith Schneider, a free-lance writer in Char- in Chicago by a special federal grand jury. lesion, South Carolina, writes frequentlyfor the Each defendant is accused of eight counts of Miami Herald, Baltimore Sun and New York conducting and distributing fake scientific Times. His report on recent efforts to silence research, and then of attempting to cover up public health, scientists and administrators ap the scheme. After several postponements, the peared in the Fall 582 issue of The Amicus IBT trial is scheduled to begin April 4. If Xmcnal. Research for this article was made convicted on all counts, each defendant faces ^Wible by a grant from the Fund for Investi- up to forty years in prison and fines totaling gative Journalism. over $40,000. ' 14 "Die Amicus Journal Spring 1983 SClBi U.S. ecutio: other r they h: neys t the In stacks the ch; Depar led, b witnes FDA i: "abust ingly flamm jury ar Sim: attornyears distres emme 1977 a key sc the res chlor.' cedura away c G.D.S turer, z In tha gain a: In tl succes that it former Chicag tantca D only t` also g knowl: atIBl those compa 15 Within the lurid laboratories ofIBT, technicians quietly witnessed scientific accuracy fade away to a welter offorgery, trickery, and lies. U.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 was employed as a toxicologist by Monsanto . witnesses, in order to prove their case. Chief in SL 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 chlordaneand 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 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 Journal Spring 1983 iplex program of auditing IBT studies* They have determined that more than 10,000 were used to register products for the Ameri can market, and they consider nearly 2,000 as primary research. Most of these were for 325 insecticides and herbicides. The vast major ity have been declared by American and Cana dian scientists to be `Invalid/' Until recently, the details of the joint in vestigation were untouchable as prosecuting attorneys, defendants, and witnesses declined to comment pending the outcome of the case. Last December, however, as part of a motion to dismiss made by Calandra's attorneys, almost 1,000 pages of secret grand jury testimony and related documents were entered as testimony in U.S. District Court, publicly revealing for the rime the nauseating saga of IBT's demise. ^Tdost infuriating is the legacy left by IBT's scandal. There are few Americans who do not make daily contact with chemicals IBT tested and declared "safe" chiefly from pesticide resi dues contained in their food and water. Since the scheme was first pinpointed, some of those chemicals have been declared by federal agen cies to be hazardous to human health and environment. Many others are accused by researchers across the country of causing ill nesses and environmental contamination. On this continent and in Europe, health authorities have begun to take regulatory action against chemicals registered with IBT data. Sweden recently outlawed eight IBT pesticides. Last year, after studying IBT data on 113 pesticides, Canada outlawed six and severely restricted application of the fungicide captan. In the United States, the EPA's final summary report on 212 pesticides registered with EBT data is due to be released in May, according to Kevin Keany, an official in the Office of Pesticide Programs (OPP). In other aons, the EPA has suspended the use of the "bicide Silvex, and canceled most uses of the insecticides toxaphene and DBCP, all of which 16 were registered with extensive IBT data. Still, one thing is all too 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 twolane industrialized corridors across America, Frontage Road is home to a dull array of squat 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 scientific standards who also knew how to make a dollar. Calandra oould 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 films to prepare the scientific 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 npt the only U.S. agency to contract IBT's services. In the early 1970s, the National Institute of Drug Abuse spent - o. 8972,0000 on four long-term feeding studies, one of which was to test the toxicity of metha done. The FDA too was a client 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 TWe Amicus Journal Spring 1983 to house IB! dogs, and cl ThroughIBT's grow for its servic quickly thrc areas of cor good, they Most impor Washington guarded, sein the midnually, enoi officers of ! $666.5 rail! factorer bas Nalco bough $4.5 million Backed b; a program c lab into Ar firm. Two si 1970, const story resear site. Caland tant staff ap was named followed b\ group leade Paul Wrigh and in Augr IBT's pathc During to ring in War business IB merit, an in tured by to. President N With the ag cally more r registration of scientific companies maintaining contracted \ IBT thou ness and w was soon in than it couli / - If they w slapstick ev- c -i_ to house IBT's horde .of rats, mice, guinea pigs, dogs, and chickens. Throughout the 1950s and early 1960s, IBT's growth lagged, far behind the demand for its services. The lab's reputation circulated quickly through the science and development areas of corporate America. IBT's work was good, they said. It was moderately priced. Most importantly, it passed examination in Washington. While its finances were dosely guarded, several estimates put IBT's revenues in the mid-1960s at close to $2 million an nually, enough to attract the attention of the officers of Nalco Chemical (1981 revenues: $666.5 million), a spedalty chemicals manu facturer based in.Oak Brook, Illinois. In 1966, Nalco bought IBT from Calandra for a reported $4.5 million. Backed by Naico's millions, Calandra began a program of expansion to turn his pioneering lab into America's largest chemical testing firm. Two smaller satellite labs were built. In 1970, construction began on a $2 million, fourstory research building on the Frontage Road site. Calandra was also making several impor tant staff appointments. Dr. Moreno Keplinger was named manager of toxicology in 1970, followed by James Plank's being named as group leader of rat toxicology. In March 1971, Paul Wright joined the staff from Monsanto, and in August, Dr. Donovan E. Gordon became IBT's pathologist. During the same period, events were occur ring in Washington which turned a river of business IBT's way. The environmental move ment, an infant in the early 1960s, had ma tured by the end of the decade, compelling President Nixon to establish the EPA in 1970. With the agency came publication of dramati cally more stringent regulations for pestidde registration and use, requiring a broad range of scientific studies. Though even the largest companies like Dow prided themselves in maintaining laboratories of their own, they too contracted with IBT. IBT thought it was ready for the new busi ness and welcomed all its new clients. But it was soon in the position of having much more than it could handle. If they were not so serious, the continuing slapstick events at IBT might seem humorous. The first time Manny Reyna, an animal techni cian at IBT, was ordered out on a mouse hunt, he thought it was a joke. Armed with a plastic . squeeze bottle filled with chloroform and out fitted in thick gloves and a white lab coat, Reyna joined a squad of technicians in a searchand-destroy mission for rats and mice running wild at IBT. DBCP Soon after he was hired at IBT in May 1971, Reyna realized that not all the rodents he tendedJnished their lives in cages. Every week, dozens of research mice and rats squeezed through the bent wires of IBT's mangled cages, raced across the long wooden racks and dropped to the grimy floor to breed with wild rodents living behind tall stacks of animal bed ding piled in the comers of the lab s feeding rooms. During the night mice climbed back up on the racks to feed on spilled food and feces, and they persisted in poldng their snouts through the bottom of cages. "For some reason, they would cannibalize the toes of the animals that were standing on the wire," Reyna testi fied in his grand jury appearance. "In the morn ing we would see where the toes had.been chewed off. So, you know, we were at a loss as to what to do----- It was a never-ending battle." The only temporary solution was a mouse hunt. For hours the armed squad would flush rodents from cover and douse them as they skittered past. "The animals were very wild," Reyna testified. "They would run from humans. So our only`chance was to slow them down with the chloroform." Once snared, technicians sacrificed their bounty, throwing the carcasses into plastic bags, then tossing the mess onto trash heaps behind the animal buildings. Reyna had other choice stories for federal investigators. More than once, he said, rats on two-year feeding studies were fed the wrong compound, something IBT never reported to its sponsors. Then there was the time the air conditioner in the brand new research build ing quit, and technicians hauled half a ton of 17 The Amicus Journal Spring 1933 to the third floor, setting up fans behind On April 14, 1971, IBT began two long BE blocks to cool hundreds of animals housed term feeding studies for Chemagro's newest There. "It made a mess, and of course the tem agriculture chemicals. The company hoped perature didn't change but a degree or two," 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 multi-purpose herbicide. hand. During the course of the Pentagon's Chemagro's protocols for the two studies irradiated beef study Reyna claimed the hunt called for feeding two groups of mice for eight became so enthusiastic that chloroform fumes een months. In addition, a control group would killed dozens of caged research mice. `T don't be established and fed a known animal carcino know how many mice died that were on tests/' gen, in order to make comparisons with the re he said. "It was just amazing; it was a substan sults found in animals fed the test compounds. tial number like 50." Was the test halted or On June 19, 1972, IBT sacrificed Chema was its sponsor notified? "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 filled 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, keeping 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 IBT's satellite labs. One day a panel truck summary report for the two studies. At the backed up to IBT's receiving dodt loaded with same time, Wright handed Smith a completed mortality table detailing the number of mice that had died and the dates of their deaths. It showed that almost no mice died prematurely. Smith told the grand jury that he knew imme diately that the table had been faked. How? Michael Black,, the technician who tended to the feeding study, had told Smith that the mor twenty-five or thirty boxes of frozen tissues. tality of the mice on Chemagro's tests had been Later Reyna found out that Gerald Kennedy, a enormous. In fact, Wright ordered 1,000 new high IBT official, had arranged with a meat mice to take the place of mice that died during processor in Wisconsin to butcher hogs in the test and specifically ordered Black not to volved in a skin bum test at the Neillsville report the addition in his records. Attorneys lab. "So he had all of this meat processed and for Monsanto said Wright would not comment sent to us evidently under the guise of being on these or any other allegations until the trial. sample 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 nail that freezer door shut to keep it from pop office of Moreno Keplinger where he learned ping open. I mean that freezer was just packed." of another problem. Dr. Wright was waiting there too. Keplinger told Smith he was wor The Justice Department's prosecution, ried about the results from the control group headed by Deputy Chief of Special Pros for the Chemagro studies. So few mice had ecutions Scott Lassar, involves fraudulentsurvived that the results from the control group research alleged to have been conducted on did not really demonstrate the animals' sus four compounds: the insecticide Nemacur and , ceptibility to developing cancer. the herbicide Sencor produced by Chemagro, Keplinger said he was not going to report now owned by Mobay Chemical; the drug the study. Instead, he had a solution. IBT had Naprosyn manufactured by Syntex to treat ar thritis swelling; and Monsanto's anti-bacterial nt 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 TNe AmicusJournal Spring 1933 not matter: feeding be; linger simj benzidine p" comparable per million to recalcul; insert them On Augu to the com; moned to t had worker immediate Chemagro ports. A C clous of th lists of rav testified th the mortal him as "gc for the Ca: with FDA r did not rea cate the m have to re:that it was That is i at least 6* next four t numbering inspection, and IBT r IBT's repc officials ar were regis; 1976. Late and asked 1982, dupl the EPA, r tory by EP widely app /1 One of 1 mg- its exp. maceuticai Californiadeveloped hoped won InManri ers visited IBT's fad signed a c 19 longewest ioaed iedmr :udies eightwould irdnothe'rejunds. hemasr they npany :esting Smith, T, was e final At the ipleted >f mice aths. It iturely. imme. How? ld^Lto iMrid Been 00 new during t not to tomeys imment he trial, r Smith into .the learned wailing as wor>1 group Ice had 01 group ils' sus- o report BT had :udy for ) for that le. It did not matter that Chemagro's protocol called for feeding benzidine to mice. Smith said, Keplinger simply calculated that the amount of benzidine painted on the skins of the mice was comparable to a dietary level of 1,000 parts per million. Smith testified he was instructed to recalculate the control group figures and insert them into the Chemagro reports: On August 15,1972, IBT mailed the reports to the company. A year later. Smith was sum moned to the office of Gerald Kennedy who had worked at IBT since 1964 and was Smith's immediate supervisor. Kennedy told Smith that Chemagro was having trouble with their re ports. A Canadian regulatory agency, suspi cious of the results, wanted to see complete lists of raw data for animal mortality. Smith testified that Kennedy instructed him to use the mortality table which Wright had given him as "gospel" in determining the numbers for the Canadians. Kennedy, in an interview with FDA agents in September 1980, said, "he 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 to 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 inspection. In December 1973, Smith finished and IBT mailed its response to Chemagro. IBT's report was accepted by both Canadian officials and the EPA. Nemaair and Sencor were registered for use in the United States in 1976. Later the EPA ruled the tests invalid and asked Mobay to repeat them. In April 1982, duplicate mouse studies were mailed to the EPA, reviewed, and regarded as satisfac tory by EPA toxicologists. Both chemicals are widely applied across the country. One of the companies attracted to IBT dur 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 hoped would revolutionize arthritis treatment. In March 1969, a small group of Syntex lead ers visited Calandra In Northbrook and toured IBT's facilities. Several months later they signed a contract with IBT for a twenty-four 19 month rat feeding study, which included de tailed protocols for blood chemistry and urinal ysis data to be recorded throughout the course of the study and at the time of final sacrifice. In November 1969, IBT began the study. In September 1971, just twenty-two months later, IBT sacrificed the Naprosyn rats. This was not reported to Syntex until 1976, when the FDA alerted corporate officers. Once again, Phil Smith was assigned to write the final report. But in October, when he began working on the blood and urine sections, he could not find the data. He searched in the animal department files and found nothing. Then he went to the clinical pathology lab and found a file containing blood and urine data through the fifteenth month of study, and a note which said the final blood and urine work had been postponed. Smith tracked down Eon Greco, the manager of the lab, to find out what it all meant Greco was not sure. So the two, men poured through the lab looking for the data, searching the freezer for serum samples, scrutinizing scheduling records, looking in slide files and time charge records- Nothing. When they were finished, the men "concluded that the final blood and urine work had not been conducted." During the next week. Smith completed a hand-written rough draft of the report and left the data tables for the blood and urine tests blank. Smith testified that he took the uncom pleted report to Wright's office, told him the tests had not been done, and said he would not sign the report. t was standard procedure at IBT for those Iwhose names appeared on the signature pages of final reports to receive copies in the company mail. So it is not hard to imagine Smith's surprise when he received the Napro syn report, opened it to the summary tables for blood and urine data and "saw that the val ues were reported for these tests." Then he Iks Amicus Journal Spring 1983 ~^7vr _Tr'"ir"n T Approved esticides eral legal uses, including dipping cattle and sheep into vats of tcxaphene for parasite control. . Services,' in an evaluation of 2,4-D, concluded in a published report that exposure to the her cause of stv at a Ocddi in Lathroo SFLVEX--A member of the bicide through skin absorption nia health controversial phenoxy herbicide could cause nervous system dis dangerous- The aftermath of the Industrial family developed in 1943 at Fort orders. The EPA has taken no Bio-Test laboratories' ordeal . Detrick, Maryland, for possible 'action to limit the use of 2,4-D, readies deep into the lives of ; use in chemical and biological and Dow, along with several \r , chemical i: 1. ' from the r use 0/ DE most Americans. Residues from : .warfare, Siivex has been a tar-, other manufacturers, is promot .same year hundreds of pesticides tested get of environmentalists for dec- ' ing more/ extensive' uses, par-* .the Dow- Cl for safety by IBT appear in ' rides. In the West, indiscriminant ticularly in aquatic"weed control. measurable quantities in virtu use of Siivex is believed to be CAPTAN--First produced in ally everything Americans eat the cause of widespread stream ' 1951, captan is an effective fun- and much of what they drink. contamination and the loss of -gicide used In treating seeds, These pestiddes have contami livestock. In Florida, a recent , . wi greenhouse plants, and con-. nated groundwater,supplies and , Florida State' University study 1 ^tainedtirTchemlcalsjfor house-.. 'reservoirs/polluted streams arid . ''found Siivex in trace"amounts j. 1/hold .iisel'/The'^diririical's, two'. -rivefsrand have beenimplicated /im?,the tissue of a' third of all ri 1mripip.m^ufacthrers, Chevron - iina host of serious health prob-':'. ./dormitory students andone quar- S vlems.'Whatdollows'is / partial.' r,&af the football team. In 1979,1, lirit.of widely applied pesticides,// -:'lhe EPA abrabtly suspended all ~Sl'r 'roughly 2` /DBCP ann in orchard; ` kill tiny w ''systems, b -farily sus/ ilDBCP. In I 5jcS^.;vV `Icmogenid: mi the SCI "/wasapowt -^geriin mic "declared by IBT^researchersJto/ Apises bf,Silvexin the Northwest. febfi /rand also t /heriouftazardous^'though -subse// tBat'S^ex. continues to be used -7a]} rqf"wbichi/lrive3jeerifihled;.l!. ` /per in rats /ptientriudies by the:EPA,/Caha-/: '/in/preparing rice fields, weed/ ritivalidl/In/additionTcriiadian'"; /year later, h aianthealth^authdrities, state" -cdhtroi in sugar cane planting,-"55 health :authtjritiesi-secured'. five/- yisesof DE health agencies, and independent. land for range and pasture use. ' lintemal memos whirh indicated^ ^pineapple ..researchers have raised doubts. - ^p2i4rP--Contained in.the Viet- ...iseyei^.isuirm'ary'lpages j6f'IBll;;, 5aa^." T-:o\RBA /^rpXAPHEISfE-- Like DDT; ah /tamrii defoliants Agent White.,r : captan .reports- w-ere rewrittenij 7he carbai: ^dnn/'and rdieldrirr(wfuch/have/ /Sadd Agent Orange,/some 70 to."' rafter Chevron.company officials;?- ^ eefibaimldby thdTlPA),-toxa// ^80/rniliion pounds'of'this phen/l humberf :^'^FieAidde are_sprayed eachft| :mrihutaiipns^IBT?;'pathblorists c &-**.* VV I fSSBSfet^ 'fades, cart Xteeh'cherr /|mark HEt __r|anonriast stretchesof forestj- 3 -ih'tb^estsFRecent' Caha^ ^fooised o: >and-for roadside weed'control.:] v ,,^dies;ghow apfen causes r .'fee ^tumors, bi :1947p duringmudhof its produc- :1BT performed at least six stud- 'j^Sndenhraildeh^fe/and ^ehdticf. iserious h- /tioniife toxapheriej was-among ' ties;6el 2,4-D which have proved ,^darnage,in.jlaborato'iry animals',;?! titife'-riatidn'Sj.fnost/populaf? pest/, /foTje'ihvalidafter IBT,officials,'? TjTand CahaBa'sh^i^sndwelfarel/ .^rillersfln^the iiiidT970sjTriord^' rin.1977,'shredded the'iaw data/ ^'deparimriTlSevefly^resSricted.'. . lltbanTOO imUion-pqunds^bfiihet`; /ihe lab' had stored for die chem- -r .^^Jtaiils/usejthere'last year/hr^l /compound' ,'^^fis'riiuhh^pari"'1-- ----- *' /HEW cor /carbaryl /restricted /man expo '/by Union .SM^l^'BrimarilKfOTt^-^.fhe. A : - * }4, 'j-rrmc; 4*0, rt'-RPA ' ' r_.___ ,, a t '"^Sary] havt `^overseas. ^'3orsrie--..':nr 1ow a g/60 miUior : /Id,;wide rr a.two-year rb .. /-which foundtoxaphenp 'caused j- : liver.chicef5iEL'rnalei'anci female./y riieaviesL. Indeperiden&esearch / rats, in more recent studie.s^by ^ /has^deteririihed/tHri/2,4;D;isT - the. PA,-;dangerous levels/jof? H;capal3eTo /mductriglTnutatlons^ ^3962|ifIBT|pfo3ticed^Cverall lipri,-'- 11 WI1A&1 MfAVk i Hf- &-* ' '^chiding st vlars,- spra / /pets, and " '/moth infet /Maryland Stargetec ; ^danger to peiivirottm ;pts proven |tions in ^guinea pi /cral years 'feiAgency f> lOARC) #2#.S onjofc irJ$M /causeof sterility m male vrorferae ' aL a OandenralGhemk^pdar.t5 ^Hirprthr of -th& Offic^of Pesti-^5'.'Ha]^a.de:'and :s TOnaidenniir a -:fi . ^i^lfai^op^C^ifdfnia^C^ifc^ -- ' `-^ s .-- ^ ^v iuit reevaiuati6-n._of. the .herbb' -. ---------------- .. -->,,* ;.- arunter^q. :;3 Sa^nmyif^okV'eetLiio-Jreo^jairii^sabrynli^^f^reeToiTn-^.;; ^1131BT pesticidegwere>sked", ':!,' jfc- V# 'ii^aF.j>BGP iri^the siate^tfilj* ,_i:dd 'that the- "dvferall,.wejglit':'; to 'duplicate the research or facs . :SaraeTyea^.Jhough Shell.and^ 'Of-"evidence "does -not indicate/ ^canceUation-bf theEr-praducts.~i vaie Dow.Chenucai'mais jithaFrisk linteria nave Seen met t Makers of three herbicides and . "'"' ' '^iSiaiMSwfeSP tibree,*msecdades chose; not to, '.';ar,d.Canada removed those prod-^ e-'not. so,.sure.Says. _ m_tliemarketplace last. S*.*V5-. 5',--,-^i5J: .v--.nsL, _ry^t\rhosl^iemi<^Is are: ' w.Jn'-'^*7.i- 0f|p,LIDPCHI/3jR ~ A Mon-J ^santo!herbid^le used iri'cdearisigT; M"viT^ ; >/4/4 :r.\-^r ''.& ranpgenia^ >rlGy;'uridertakeii^ - by-theNCr.ronduged tfiSt'DBG^?: iwas^fpSwerfu] stcmaciiji3E,6ui^^ -/weeds froni;`ijnioii''fieIds.-:(^<afelRBR0MUR0N-Aii-4 ^diher^herbicide `nrnhufacturedj Swig:fum::eiba:Gergy/| v ,S:dsed in carrofSelds. ' .': . and^alsofpFOducedjjr^^ca_ herbicide^! 1 ni*.T\^ tv t?._ >-gdS * I'.fjTSriisa. 1 - r'.''f-.>'5r Ji&M Skfo$$ relfare,.; xicted/; san'In": eeiion' .other 5 l tbxi*S ig can:;,, mtlya', is un-/ s com- ?| : .' w-n. -1 r* say^np^ takeiiV nerrof everal' to test 5 could BCPr a. intro* lag to." rstudr\ hr less emical | \ I977fc oe'>the 'M >u&sW}BGPrvsj _ ^ :^GA]RB^YL^A.m^nfaei:^i ri't^Si^unate Family pf,mfe^P .,.VT` <x- "cdes.carSar'/I was cnecj ' "te^j&emicalS'cited u^aUaod.1^ r-'mS^HEW.report Canadian cjom fields. -I^EHOSPH^MlD'QCv^- A_| fd^^eigyfmsedScide -solJ.byJ I ^Cherajn inTCaiiada and Cali-sAr1 Stela: r^&JBJU^Al^CRYL--Manufac-^ /Jtilted by^|t)ie-5^errnan furmj St Hbechst as a mltaade:-; ; ' V 5a* ' 4j>rALL|PHOS:J- ' At.other, TniTtaade manufactured by a sub-r^. '.tHEV^cominission.' wrgFelth3>R4nam:era: defbliah^AgeEt&iBKie^g ^fsKfisrry of Hercules.Chemical. ^ccrbaryiaShould r^ uranedmtgE^',"A uchoitij^s.-rIrrnr-.V^: `^r^Scted to prevent nslP^f ; --Kkith. Schnieder _ ymaiF exposure.: r . . SttndyCto'^rep^ce:S27QCu^itliei ; liy7l3man ^Carbide sihce495|p v^cutiawed- herhiader:2 5^X-'S--I `l nei^y-^liia^Krand^^P^^ -conrobnentrbfAgeDlOrange^fef^ 5f bary] ha1^beeubtId, about halg overseas:'In the United Siafes^-i -ba& yet td jreceTveJall registfa-"? : ;T-St i1 ,r^u`/ss^em-^ao4r'w' -averag^e'-s-.- an e'"s=p,*m*'a*ir ' : SO'rnillian'pcHind's annually iidbn'firpih'tiie EE4 "this insecii- in'*-. *'ll v> ">- . ~'t TJ * TTm M .'+ | Biffg". S*Wi^i S . * a.V . --T^-Tr-i*:^ i*rrDC rirlfe SP8e.offttrj^BS; - '-n--rMgt, rr^^?spraTys and powd!ersjfof ::'pefeFan^nn spraying fbFgyp. 7,fc^SjClirreritW: penhelbrmTiSmJ tm moth fitfestatiohs-frcnr Malnetb-. :-va'xanditiortal -registratFbjitand:;E:.Vraiw-v Maryl^LS. Carbaryl has _been' - rnnuons'orpounds are"suppi:ed' targeted ,by researchers .as -. to applicators under the.EPA's^ danger to human health and the- /controversial "emergency;exr enviro.n. inent chiefly because of^ 5'empdon"- clause. ;7v'"- '&&&&& proVenability to causemUm^il^^HARVApE-- Uniroyul's dis-'; tipnsiih the fetuses of^doga^^Kp^ttect.cbttop defol^nt wa? re.- .. guTnearpigt, and rabbfe.r&v^g^qentiy.discoverediby'California " ;er^ye^.ago,.AeMernadoh^fepffidais' to be a potenfiaf car-' ' st?- .4gg ,?^-v V- . f.-Vr 3W rft r 7A- Sri-r^c:^ i.-. ** ' 'A'gency^rResearch. on^Canoer" [.'dndgen. Lori Johnson, chief of {.lAEO- studied carbaryl arid [' the California Agriculture De- ' found it to be a carcinogen. In -b partment's pesticide division, ts 't '- i. .. r', w ., - ; . '- C '. - -LM f---*" . J - - .-,;1h,.. . r The Aureus Journal,' Spring 19$$ ^..2"-' :-S ried to the signature page and was shocked fsee his name written in. Things got even stranger a few days later when Smith's rough draft was returned from IBT's typing pool. He turned to the blood and urine summary tables and discovered they were filled in by what Smith "recognized as Mr. Plank's hand writing and some [data] in what I recognized as Dr. Wright's handwriting." . NAPROSYN In an interview with FDA agents in May 1980, James Plank "denied that he knowingly inserted false information in this report when he prepared it." Plank did identify his hand writing from the rough draft and said he pre pared some of the tables. But Plank advised the FDA that he was sharing an office with Wright at the time and "he was often given reports to plug in the data by Dr. Wright." The numbers juggling, however, did not tisfy Syntex- In mid-November 1971, two weeks after IBT mailed the Naprosyn report to Palo Alto, Dr. Robert Hill, a Syntex toxicol ogist fired off a letter of reprimand to Calandra. "From past experience I am convinced that the report would be rejected by regulatory agen cies in the United States, United Kingdom, Canada, and Germany," Hill wrote. "Would you please see the report is corrected and returned at the earliest." To revise the report, Keplinger asked IBT's pathologist, Donovan Gordon, to evaluate stom ach tissues taken from the Naprosyn group. Through his microscope, Gordon saw lesions on the tissues caused by anemia and which he concluded were "induced by the drug." To sup port his findings, he wanted to look at the raw- blood and urine data. He called Dr. James Von Druska, supervisor for the Clinical Pathology Lab,and asked him to send the data oven After another thorough search of the pathol ogy lab. Von Druska called Gordon and told him the data could not be located. As a result, Gordon referred to the numbers published in fcT's final Naprosyn report, and when he saw Wat all 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, Gordon told the grand jury. He listened briefly to the men who had come to his office, and then waved them out. "I'll take care of it," 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? 22 : ThE AmicusJoUti_N Ai Spring 1SE3 i / In th l "Ti Only careful T/ logical evaii cause of dear ` monplaceat i from their c [ examination . TCC researc nym, TBD/' internal sun `. Manny Re t . .. the conditk F Swamp that /I, ` odorous cat -/^/problemR Jap': ; little that co Frv ;/ - It is also "tri?"' mony that L; Plank were Swamp. In the room "f Plank's ide Still, for at was built, a ' dozens of tt while it ren 7. ' Eight mo ary or Mar*, prepare a s: v handed Snr ' g'-Ji.T. / incredulous :. ing the stuc At about 1 name of L Swamp wr 1 individual!; " .trials gang : expressly switch. Pei T-- ffom a su; ; V ; group of a ; study" gru dead anim . One of t identified June 1972 In the column next to the rat's cage number, they would mark "TBD/TDA" It meant "too baaly 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 23 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 18, 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 appoint ment, 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 The Amicus Journal Spring 1983 t one occasion" Calandra joined Kennedy tour of the Swamp. When the TCC animals were sacrificed in July 1973, Kennedy was assigned to write the final report Kennedy looked at the raw data tables and decided they were a hopeless mess. He told Keplinger "the study would be impos sible to report without disclosing all of its inadequacies." Keplinger "dearly understood and acknowledged" Kennedy's dilemma, but told him to emphasize Gordon's pathology find ings and to "downplay the study organization, animal disposition, and mortality." On October 6, 1973, Calandra, Keplinger, and Kennedy met with Paul Wright, now back with Monsanto. Wright had been responsible for the TCC study for its first fourteen or fif teen months, Kennedy testified, and was well aware of the problems of the Swamp. Kennedy also told the grand jury that after Wright left IBT, "he and Dr. Keplinger had kept in con stant contact while the study was being run." # HARVADE The meeting lasted for hours. Of particular concern was Gordon's findings, reported in a preliminary report, that testicular lesions caused by TCC were found in rats fed large and small doses of the compound. Wright was extremely upset with the findings. He told the group that age, nutrition, the conditions of the rats, and stress could account for the effect, and he urged Calandra and Keplinger to con vince Gordon to change his conclusions. Between October and February, Kennedy, assisted by Keplinger and Gordon, worked on the final report which was mailed to Monsanto on March 21,1974. There was no further word about it until October 10, 1974, when Wright wrote to Keplinger requesting the pathology data and tissues for rats fed the lowest doses. In late December or early January 1975,. Calandra called a staff meeting to discuss the TCC study. It was attended by Keplinger, Gordon, Jim Plank, Kennedy, and Dr. Florence JUjnoshita, a toxicologist who joined IBT's staff ^PSeptember 1973. Just the year before Dr. 24 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 mortality table was false, the purpose and use of the so-called research animals was false, etc." It was decided that Dr. Kinoshita 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 foranother 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 IBTi Monsanto continued to be dissatisfied with . 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. He AMrcusJournal Spring 1983 Like Wright, Calandra 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 Calandra 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. Calandra 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." hi 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 front 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 not want to leave EBT 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 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 IBT'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, Gross made his first visit to IBT to look at the raw data for the Naprosyn report. He returned on July 12. During these visits Gross saw for the first time IBTs use of the TBD/TDA acro nym. He also saw that rats listed as dead in TYje Amicus Journal 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 group 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 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 Cburt 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 to. his attorney, is working as a con sultant in the Chicago area. Convinced that Calandra was not going to cooperate, the FDA began making plans for a criminal prosecution. Tb 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 IBT's studies on the herbicide 2,4-D was destroyed. (Federal agents say. And data for at least six 26 '. V:.: .. . As for IBT, 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 IBT 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. lta Amicus Journal Spring 1983 AE to I Integrate by Mary B The lygus cotton grov Sanjoaqui: lions spray team of sciniausinga came up v bugs increc The ma; Andrew P. at U.C.'s . Control, ex are good f would drop early helps increases t budding hi This stm research ri grated pes: cut theloar saving fam Despite pesticides thirty year; doubled. E: outbreaks mies. Care' nated watt taken hum on a treadr for pestidt as pests be ral predate Twenty : Spring ale indiscrimir Mary Ban Felton, Cat 27