By Keith Schneider | Part Two of a Series (Link to Part One)
IBT – Guilty
How many studies are no good?
ONE OF THE most extraordinary white collar criminal trials of 1983 ended in Chicago October 21 when three former officials of Industrial Bio-Test Laboratories were convicted by a federal jury of fabricating key product safety tests used to gain government approval for marketing two popular pesticides and two commonly used drugs. The convictions coming after six months of testimony and nearly eleven days of jury deliberation closed one chapter in the IBT saga regarded by many experts as the most massive scientific scandal in the history of this country and perhaps the world.
The same could be said for a host of other groups. Among the gravest threats to the health and safety of all Americans is inaccurate science, sloppy science and in some cases, fraudulent science. The aftermath of the IBT scandal reaches deep into the lives of most Americans and has proven to be an environmental and public health emergency. Residues of hundreds of pesticides tested by IBT and declared safe appear in measurable quantities in virtually everything Americans eat and much of what they drink. These pesticides, among them the insecticides toxaphene, DBCP, carbaryl and the herbicides 2,4-D and 2.4,5-T, paraquat and picloram have contaminated groundwater supplies and reservoirs, polluted streams and rivers and been implicated in serious health problems throughout America. The EPA has moved to limit the uses of several of these chemicals after subsequent testing showed them to be unsafe, but well over 100 other agricultural chemicals and countless industrial chemicals IBT and other independent laboratories tested remain on the market, and their effects on human health and the environment are unknown.
But the convictions also added a new urgency to a sensitive public health crisis that four federal regulatory agencies are now trying to solve. How many product safety tests used to register thousands of drugs, pesticides, and industrial chemicals sold on the American market are scientifically valid?
Congressional critics charge that high ranking officials at the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA) and the Consumer Product Safety Commission (CPSC) acknowledge that the exposure of IBT in 1976 opened a huge hole at the most fundamental level of the nation’s regulatory system: a hole that has not yet begun to be closed. Even more disturbing, say critics, most of the 60,000 or so chemicals in regular use across the country do not have adequate scientific studies supporting their registration and continued use. “Ever since we recognized the magnitude and importance of what happened at IBT, it’s just been an ordeal to try and come to terms with it,” said Kevin Keaney, a special assistant at the EPA’s Office of Pesticides Program. “We’ve tried to close the data gap, but every time we think we are close, something else comes up.”
Added Skip Stiles, an aide to Representative George E. Brown, Jr. (D-California), whose House subcommittee on department operations, research and foreign agriculture held hearings last July on the IBT affair: “IBT was the first warning of a huge problem this government is facing. I think we are going to find more problems before we solve the essential questions in this whole issue. How many studies are no good and for what products? It’s clear that IBT was not the only laboratory submitting substandard research. There is little doubt that we’re going to go through a painful cycle before we come up with a way to deal with this.”
At issue in the marathon trial, which began in federal district court in Chicago on April 4, are four long-term scientific studies used to market the herbicide Sencor; the pesticide Nemacur; a drug used to treat arthritis inflammation called Naprosyn, and TCC, an antibacterial agent contained in most popular deodorant soaps. All the compounds have been retested and have received government approval for sale nationwide.
Consider this: IBT performed over 2,000 key product safety tests approved by federal scientists to market 212 agricultural pesticides. After a seven-year long review of its files, the EPA ruled this year that less than 10 percent of the studies are scientifically valid. Just a handful of the invalid studies have been replaced, the agency said, and most of the pesticides continue to be sprayed on fields and forests. Late in September, the agency also revealed that it is a long way from solving problems associated with the integrity of hundreds of studies produced by IBT and other large independent laboratories.
Consider this too: In early October, FDA concluded a twelve-year long investigation which found that just one-third of 700 active ingredients in non-prescription drugs were “proved effective, as well as safe, for their intended use.” IBT conducted hundreds of studies for review by FDA scientists, and the agency has never released which products IBT tested.
Add this: the National Toxicology Program, a little known division of the Department of Health and Human Resources, announced in October that it has discovered severe problems with the scientific procedures of a large independent chemical testing laboratory in Louisiana named Gulf South Research Institute. That lab performed extensive work under contract with the government to test agricultural and industrial chemicals. The revelations of sloppy work have placed the government’s twelve-year old 180 million US Dollar program for testing suspected carcinogenic chemicals in jeopardy. “Problems with the quality of scientific studies supporting registration decisions are something this country is going to have to deal with,” said Steven d’Arazin, chief spokesman for NTP. “With too many of these chemicals, all we have is just one big question mark. We can’t say with any degree of authority whether they are safe or unsafe.”
In theory, the federal government’s traditional system for insuring the safety of products is simple to understand. Manufacturers must file a comprehensive set of scientific safety tests produced either by their own laboratories or by some 400 independent testing firms. These tests are expected to be conducted under the most rigorous scientific standards. When completed, the studies are sent to scientists at the regulatory agencies where they are carefully reviewed. If federal scientists are satisfied that the chemical will not jeopardize human health or the environment, basing their decisions on the results of the safety tests, they will approve the product for registration. Few people considered just how fragile this system was until they learned about IBT.
IBT, based in Northbrook, Illinois, north of Chicago, was once the nation’s largest independent chemical testing firm. Between 1952, when the firm was founded, and 1978, when a US Justice Department investigation closed the laboratory, IBT conducted more than 22,000 critical research studies for nearly every major American chemical and drug manufacturer, dozens of foreign concerns, and several federal agencies. Almost half of the studies were used to gain federal registration for hundreds of drugs, food additives and pesticides still sold on the American and international markets.
Convicted in US District Court of fabricating just four of the product safety tests were Dr. Moreno L. Keplinger, 53, former section head of toxicology; Dr. Paul L. Wright, 48, former section head of rat toxicology; and James B. Plank, 40 former assistant manager for toxicology. In July, US District Court Judge John A. Nordberg declared a mistrial in the case of a fourth defendant, Dr. Joseph C. Calandra, 65, IBT’s founder and former president, after Calandra was admitted to a hospital to undergo triple bypass heart surgery.
Dr. Keplinger was found guilty on six of eight counts of fraud, falsifying statements and falsifying scientific data submitted to the government. He faces a possible prison sentence of thirty years and a 42.000 US Dollar fine. Dr. Wright was convicted of three counts of mail fraud and falsifying statements to the government. He faces a possible fifteen years in prison and a 21.000 US Dollar fine. And James Plank was convicted of five counts of mail fraud and falsifying statements to the government. He faces a possible sentence of twenty-five years in prison and 32.000 US Dollars in fines.
The IBT trial, which began April 4 and generated over 16.000 pages of court transcript, was the longest criminal trial in the Chicago Federal Court District in eighteen years. Soon after its start it became clear that the proceedings would last far longer than the original six week estimate of prosecution and defense attorneys.
The opening statement by Assistant US Attorney William Spence, in which he charged the defendants made up page after page of data and put it in the reports, “was interrupted sixteen times by objections from defense attorneys. Much of the trial took place in Judge Nordberg’s chambers where three prosecution attorneys, up to nine defense attorneys, the defendants, and several legal assistants met well over one hundred times to debate technical legal points away from the jury.
None of the six men and six women of the federal jury have been trained in scientific discipline before taking their seats on the federal panel. Then for six grueling months they were introduced, then inundated by a cascade of mysterious details concerning pathology, biostatistics, tumor identification, animal necropsy, chemical dose relationships and other arduous disciplines that make up the relatively new science of toxicology.
The long days of dull testimony gave bloom to a cynical humor that coursed through Judge Nordberg’s courtroom from time to time. In late July, a federal Marshall told Harvey Silets, attorney for Plank, that the jurors had started a betting pool over how long the trial would last. On August 1, juror Michael DeFrancisco, who was repeatedly admonished by Judge Nordberg to get more sleep before arriving in court, tried to gain the inside track in the pool when he sent a note to the judge asking how many more witnesses would be testifying and whether witnesses who had testified previously could be recalled.
Sixteen days later, Judge Nordberg greeted the jury members by holding up a page of the court transcript festively decorated with yellow backing and announced that the trial had passed page 12.000. Said Nordberg, brandishing the lone page: “That is an historic milestone, and we will preserve it in the court file for posterity.”
Yet interspersed between the days when scientific experts for the prosecution and defense contradicted each other were moments of sensational testimony that kept the jurors on the edge of their seats and had the twenty-first floor of the Dirksen Federal Building, where Judge Nordberg’s court is located, alive with spectators. It was during these exchanges that the chilling story of the IBT affair was revealed [see Spring 1983 cover story].
In late April, James Rawlins, an IBT technician testified that in the early 1970s filthy conditions in the laboratory’s animal feeding rooms caused countless deaths of rats and mice that were not reported to sponsors of the studies or to the government. “There were feces, hair, and urine stuck to cages. They were heavily saturated,” said Rawlins.
In May, Philip Smith, the star government witness, spent two weeks in the witness stand. He said he was ordered to fabricate much of the Naprosyn study and that he refused, the data tables were filled in and his signature was forged in the final report. Other prosecution witnesses testified that the defendants organized a “scheme” to hide the high animal mortality rate and that data was falsified regularly.
Several jurors, however, said in interviews that the decision to convict the defendants turned on the testimony of Merrill Thompson, a Chicago lawyer hired in 1976 by Nalco Chemical, IBT’s parent. Thompson testified in August that after working with company officials for nearly a year, he refused to accompany Dr. Calandra and Dr. Keplinger into a Washington investigative session in December 1976 to answer questions that the FDA was raising about several company studies.
“As I got into it and worked on these things more… and worked with IBT people more and looked at the evidence of other practices in the industry, I decided I couldn’t defend IBT’s practices,” said Thompson.
In the trial’s last six weeks, defense attorneys argued that the studies in question dated back to 1969, in the case of Naprosyn, and the early 1970s for the others, so long ago that witnesses for the prosecution could not possibly remember details of the studies. They charged that some witnesses for the government were forced to testify or face prosecution themselves, and other prosecution witnesses lied, particularly Philip Smith, in order to cover their own misdeeds. But defense attorneys also acknowledged the existence of an animal feeding room known as the “Swamp” where a malfunctioning watering system sprayed rats and mice, causing unknown numbers of deaths of test animals.
Witnesses for the defense conceded that critical information was missing from IBT’s files, but that data used to replace it had not been fabricated. In all, argued defense attorneys, the laboratory’s difficulties were the result of untried and pioneering practices begun by the company, and not the result of fraud.
“Conditions and practices under which the toxicology tests were conducted at IBT in 1970 and 1972 were well within the standards applied to other laboratories nationwide,” said James Robertson, attorney for Dr. Wright. “There were not any real standards. There were no regulations. Toxicology was in its infancy at the time.”
But jurors felt otherwise. ”They were dealing with chemicals that could cause cancer and other problems,” said jury Forman Gerald Rasmussen, an unemployed pipe fitter. “To have done the things they did is almost unimaginable.”
The IBT scandal was first discovered in 1976 by Dr. Adrian Gross, then a pathologist with the FDA, now a senior scientist with EPA. Dr. Gross’s discovery was made in connection with a series of sensational hearings held in 1975, 1976 and 1977 by Senator Edward M. Kennedy in which a parade of FDA and EPA officials publicly disclosed that scientific research being conducted by the nation’s drug industry and by the petrochemical industry were being deliberately falsified.
The Kennedy hearings and the discovery of IBT’s activities led to changes in how government monitors product testing laboratories. In 1979 the FDA instituted the “Good Laboratories Practices” statute, which among other things standardized the requirements for caring for test animals and insuring accurate record keeping. The FDA also opened a new division with a 5 million US Dollar annual budget and 100 staff members to investigate independent laboratories and audit studies submitted to regulatory agencies. Yet, in one of its first reports issued in 1979, the FDA said that the work of more than a dozen independent laboratories suffered from “serious deficiencies”, in the quality of their scientific procedures. Neither the FDA nor the EPA has said how many studies these laboratories produced for government review or which products are involved. “We are still trying to dig out from the IBT mess,” said the EPA’s Kevin Keaney. “Maybe that will be the next project.”
Staff members at independent laboratories insist that better research is being conducted today in reaction to the IBT revelations and the federal government’s response. “We’re heading in the right direction, where before this many laboratories were not heading the right way,” said Joseph Townsend, director of the quality assurance section at Bio/Dynamics, the nation’s third largest chemical testing firm, based in East Milstone, New Jersey. “IBT gave this industry a black eye and we’re going to be suffering with it for a long time.”