Industrial Bio-Test Laboratories

IBT was founded in 1953 by Joseph C. Calandra, an Italian American professor of pathology and biochemistry at Northwestern University.[8][9] Calandra, the first of his family to pursue higher education, contributed to the concept of toxicologically innocuous doses during his tenure at Northwestern.[9]

Described by his colleagues as a "man of high scientific standards who also knew how to make a dollar", Calandra was an effective entrepreneur; his laboratory was contracted by the Department of Defense to evaluate irradiationally preserved food within its first year of operation.[10][11]

By 1960, IBT reported that its professional staff included 12 biologists, five chemists, a mathematician, four physicians and a veterinarian, and that it employed 16 technicians. Calandra was president and director and John H. Kay was the associate director. At that time, it listed its research areas as "industrial toxicology, food, drugs, cosmetics, pharmacology, radioisotopes, medical, dental, and veterinary products".[8]

By the early 1960s, IBT had attained a significant reputation for producing quality work at a reasonable price.[12][13] As of mid-decade, it had annual revenue estimated at nearly $2 million US.[12]

Nalco Chemical acquired IBT in 1966 for an estimated $4.5 million.[12] Utilizing the company's new financial prowess, Calandra oversaw considerable expansion of the company and constructed two new facilities.[12] IBT began conducting tests on polychlorinated biphenyls (PCBs) in 1969.[14] In 1970, Calandra began construction of a large $2 million laboratory and made two executive appointments: Moreno Keplinger as Manager of Toxicology and James Plank as Group Lead of Rat Toxicology.[12]

In March 1971, IBT hired Paul L. Wright, one of Monsanto's toxicologists, to oversee its PCB testing.[14][15] Donovan E. Gordon joined IBT as a pathologist in August 1971, and IBT finalized its safety analysis of PCBs in November 1971.[14]

Irregularities in IBT's data were discovered in April 1976 by Adrian Gross, an investigator at the Food and Drug Administration, whose aide retrieved one of the laboratory's naproxen studies that had been conducted for Syntex, a pharmaceutical company recently outed by a whistleblower.[1][16][17][18] Gross examined the study further; it struck him as being unrealistic and piqued his interest.[17] The FDA proceeded to probe IBT, and Gross personally inspected its facilities on April 11 and July 12, 1976.[12][19][20] During Gross' physical inspection of the laboratory, he gained access to the study's raw safety data and found frequent references to an unknown acronym, "TBD/TDA," which he said perplexed him until learning that it denoted a testing animal whose body had "too badly decomposed."[1][21]

Revelations of suspected scientific misconduct would go on to be presented in March 1977 at Senate Subcommittee on Health and Scientific Research hearings held by U.S. Senator Ted Kennedy (D-MA), in which the integrity of safety data produced by IBT, as well as G. D. Searle & Company and Biometric Testing, Inc., was publicly called into question by FDA officials.[18][22][23] Calandra vacated his role as president of the laboratory on March 25 and was succeeded by A. J. Frisque, who had previously worked as a research executive at Nalco.[24] Plank parted ways with IBT in April, and Philip Smith, who would later testify against the laboratory, was "fired and given 20 minutes to clean out his office" in approximately June 1977.[1][12][25] That same month, on June 2, IBT would also shred more of its internal documents, an action which Frisque characterized in a subsequent official statement as being "entirely inadvertent."[18][26]

IBT was criminally implicated in 1977 for producing fraudulent studies on widely used household and industrial products, including Nemacur, Sencor, Naprosyn, and trichlorocarbanilide.[12][25] The magnitude of IBT's scientific misconduct was considered to have been extensive: 618 of 867 (71%) of studies audited by the FDA were invalidated for having "numerous discrepancies between the study conduct and data."[5][27] Consequently, IBT would later be described as being "at the center of one of the most far-reaching scandals in modern science, as thousands of its studies were revealed through EPA and FDA investigations to be fraudulent or grossly inadequate."[28]

Although the criminal case against IBT and its employees was proceeding, information about which chemicals were "suspect" because of IBT's misconduct was kept confidential by the Canadian and American government agencies responsible to regulating them.[29]

In early 1980 the Regina Leader-Post obtained a Canadian government agency list of 106 chemicals about which there were concerns.[29] The Regina Leader-Post also obtained a letter written Jan. 25, 1980 by R.O. Read, who was Chief of the Division of Additives and Pesticides in the Bureau of Chemical Safety Health Protection, a Branch of Canada's Health and Welfare Department, to, that said: "All long-term rodent studies and multigenerational reproductive studies performed by IBT are considered invalid," and noted that the Canadian government had sent letters to a number of chemical companies pointing out that many had "failed to submit the information required by the Environmental Protection Agency and the Canadian health protection branch."[29] Documentation obtained from a variety of Canadian and American sources by the Regina Leader-Post included sloppy or inadequate record keeping that invalidated test results. In a number of cases, sick test animals were replaced with healthy ones, resulting in invalid test results.[29]

In October 1983, three former officials of the company were convicted by a US federal jury of fabricating key product safety tests used to gain government approval for marketing two popular pesticides and two commonly used drugs.[6] They were convicted after one of the longest criminal trials in US history, involving six months of testimony and nearly eleven days of jury deliberation. At the time it was regarded as "the most massive scientific scandal in the history of this country and perhaps the world."[6] The decision was subsequently appealed and upheld in United States of America v. Moreno L. Keplinger, Paul L. Wright, and James B. Plank.[30][31][32]

Eric Francis and Marie-Monique Robin have cited IBT's research into the safety of polychlorinated biphenyl, which was not investigated, as also being potentially fraudulent.[28][56]

Philip Smith later testified on October 28, 1991, during a court case against Monsanto, that he had observed PCB data falsification during his employment as an assistant toxicologist at IBT.[14]

The Ecologist claimed in a 2007 article that IBT had provided expert testimony against Douglas Gowan during a court case in which Monsanto allegedly sought to discredit and silence him over the wanton disposal of PCBs and other toxic waste at Brofiscin Quarry.[57]

In April, 1980 the Regina Leader-Post obtained and published a Canadian government list of more than 97 chemicals tested by IBT for which studies were considered "suspect". In June, 1980 an additional nine chemicals were added.[29] According to Fagin and Lavelle in Toxic Deception, Wright tampered with safety data for Machete and monosodium cyanurate, both Monsanto products.[58] IBT performed safety tests on Dinoseb, which was later discovered to cause birth defects and then pulled from the U.S. market in 1986.[59] IBT also originally evaluated the safety of atrazine, a herbicide now thought to be an endocrine disruptor, suspected carcinogen, and possible teratogen.[60][61][62]