1979
In 1979, CMA lawyer, Don Evans, advised CMA coordinator, J. Young, that the MCA-coordinated companies’ failure to revise the Safety Data Sheet, (SD-56) because of its deliberate and considered (but undisclosed and contrary to MCA’s own stated policies) policy not to place cancer warnings on vinyl chloride, might, predictably, be interpreted as illegal or immoral, if it were ever disclosed.
The lawyer cited as supporting authority for his recommendation, the existing scientific understanding of the mechanisms of chemical carcinogenesis, as well as the “one-hit” large, and extremely expensive, mega-mouse toxicologic studies conducted by the Consumer Products Safety Commission (CPSC) that had shown significantly increased cancer rates in animals that had sustained only a single two-hour 5,000 ppm exposure.
Instead of providing cancer warnings for vinyl chloride (benzene was also mentioned as providing justification), in 1979, the CMA simply discontinued their entire Safety Data Sheet program.
Notwithstanding their candid admission that forty percent of the chemicals included in the MCA/CMA Safety Data Sheet program posed chronic health hazards that were not referred to in their respective MCA Safety Data Sheet, no warning of these chronic hazards was ever included.
Although the official guidelines set forth by the Labeling and Protective Information Committee in its “LAPI Manual” required such warnings, the MCA Group, uniformly, failed to mention chronic effects of vinyl chloride in its labeling.
The MCA touted its LAPI Manual as authoritative and highly respected, emphasizing that it had even been adopted as law by some states, such as New Jersey.
In 1979, over nine years after the MCA breached its own official labeling policy guidelines contained in its self-serving highly touted and promoted LAPI Manual, the MCA made the deliberate and calculated decision to discontinue the entire MCA Safety Data Sheet (SD-56) program rather than include accurate warnings on MCA warning labels, or chemical packaging.
1/11/79
On January 11, 1979, the Vinyl Panel’s Audit Task Group (ATG) submitted its draft final report, entitled “Draft Final Report of Audit Task Group on Lifetime Inhalation Study on vinyl chloride at Industrial BIO-TEST Laboratories, Inc.,” and recommended the Vinyl Panel accept the report generated by the veterinary pathologist at Experimental Pathology Labs (EPL) as the final report of the study.
The ATG further recommended that no further pathology work be done on the IBT study (stating that this was the recommendation of the EPL veterinary pathologist, Dr. William M. Busey, DVM, Ph.D.).
IBT was instructed to consider the project it had been commissioned to perform in 1972 to be closed.
February and March 1979
In February and March of 1979, various articles appeared in the popular, trade, and scientific press relating to the announcement of an apparent excess of brain cancers that had been discovered at Union Carbide’s Texas City, TX plant.
Excess cancers were also soon to be reported at Dow’s facility in Texas City, and at Monsanto’s Texas City facility, as well.
3/1/79
By early March 1, 1979, the MCA-coordinated vinyl manufacturers were extremely concerned.
All of the plants involved in the so-called “Texas City incident” were known by the MCA-coordinated vinyl manufacturers to have participated in the previous, corrupt, epidemiologic studies that group had sponsored previously.
Companies participating in the MCA-coordinated studies recognized that the association of brain cancer with VCM exposure was not new. However, this was the first incidence where such an intensive investigation of brain cancer per se had been conducted.
Although the government’s original focus was on the potential role played by vinyl chloride in causing the Texas City brain cancers, the MCA-coordinated vinyl manufacturers did not identify, or did not accurately identify, those persons from the Dow, Carbide, and Monsanto plants that had previously been studied by the UOM, TCA, or EEH over the course of the last 15 years. Neither did the companies accurately identify those of its employees who had sustained significant exposure to vinyl chloride in the course of their employment at the Dow, Carbide, and Monsanto plants in the Texas City area. Neither did the MCA-coordinated vinyl manufacturers reveal excess brain cancer rates, even where (as in the case of Union Carbide at South Charleston, WV, and Olin in Assonet, MA) they had been recognized by the MCA-coordinated vinyl manufacturers as having occurred.
3/5/79
By March 5, 1979, Carbide was aware of an excess incidence of brain cancers both at its Texas City, TX, and South Charleston, WV facilities.
However, Carbide’s public pronouncements were to the effect that Carbide did not have sufficient data to say whether the preliminary figures indicated an excess at Texas City, and said nothing, whatsoever, about brain cancers at South Charleston.
Despite the fact that Carbide was giving the appearance of cooperating with the government in the Texas City investigation, because it was aware that the government was likely to publicize the problem, Carbide considered it was left with no choice but to launch intensive epidemiological studies at both Texas City and South Charleston – all without telling the U.S. government about it.
Because Carbide was aware that multiple chemical exposures at its plants would make teasing out the cause of the excess brain cancers difficult, if not impossible (especially without Carbide’s honest and forthright cooperation), Carbide doubted the cause for the Texas City brain cancers would ever be found.
3/5/79
On March 5, 1979, John R. Lawrence, Technical Director of the SPI PVC Safety Group, wrote to member companies enclosing for their internal use only, a copy of a misleading position paper Dow had developed with regard to the Texas City incident. Dow, like Carbide, denied there was any proof of a problem with brain cancer. Dow claimed that what it knew about vinyl chloride enabled them to conclude that brain tumors were not a problem in Dow’s workforce. Further, the Dow position paper cited, favorably, epidemiologic studies on large worker populations in the United States and Great Britain that it claimed was evidence against any connection between brain tumors and vinyl chloride exposure.
3/7/79
By the beginning of March, other MCA-coordinated vinyl manufacturers, besides the three involved in the Texas City incident, discovered brain cancers among their vinyl chloride exposed workers, some of whom had been included in the previous MCA-coordinated cancer studies, but many had not been included in any population that had been the subject of epidemiologic studies, and never would be.
3/14/79
On March 14, 1979, although several U.S. and Canadian epidemiologic studies were recognized as having shown higher incidence of brain cancer in workers exposed to vinyl chloride and that there had been warnings of this type based on some of the animal studies, too, the MCA-coordinated vinyl manufacturers said nothing about it in their public pronouncements.
3/21/79
At a VCRC meeting held March 21, 1979, the MCA-coordinated vinyl manufacturers learned that none of the ten identified brain cancer cases from Carbide Texas City had been included in the TCA or EEH epidemiologic studies.
Dr. Utidjian, who had just the previous year been employed by the MCA’s independent contractor, EEH, was now employed by Union Carbide.
Dr. Utidjian reported to a reassured Vinyl Panel that his opinion was that, with the exception of Dr. Joseph Wagoner, everyone participating in the government’s initial investigation at Texas City had agreed that the evidence acquired to date mitigated against primary brain tumors caused from exposure to vinyl chloride.
Dr. Utidjian reported candid information about the EEH studies to the Vinyl Panel[xvii], in contrast to the information the MCA-coordinated vinyl manufacturers and the companies directly involved in the Texas City incident, was providing the government.
The VCRC discussed in detail Dr. Maltoni’s research showing brain cancer in animals exposed to vinyl chloride.
3/26/79
As part of a concerted effort to avoid the brain cancer issue from becoming a problem as a result of the Texas City incident, the MCA-coordinated vinyl manufacturers took a very low-key approach to publicizing what they knew about brain cancer and what they knew about Texas City to their employees.
For example, although companies like PPG considered having the plant managers write letters to employees with regard to the Texas City incident, after due consideration, it was decided that a letter to employee homes at this time would be overly inflammatory in view of minimal employee concern generally, and upcoming Union negotiations.
Because they knew that the Unions were very much concerned, in part, with safety and health, the decision was to tell the Unions nothing about it and to give the employees nothing definite, or, if possible, nothing in writing.
April 1979
In April 1979, NIOSH and OSHA (L.J. Bahlman, V. Alexander, P.F. Infante, J.K. Wagoner, J.M. Lane, and E. Bingham) published Joint NIOSH/OSHA Current Intelligence Bulletin #28, entitled “Vinyl Halides: Carcinogenicity, Vinyl Bromide, vinyl chloride, and VinyliDene Chloride (VDC)” in the American Industrial Hygiene Association Journal.
8/28/79
By the late 1970’s, most manufacturers, including Conoco Chemicals, had stopped Using inaccurate charcoal tubes and had begun Using inaccurate passive dosimeters, instead.
In a completely fraudulent use of charcoal as a standard for comparison, passive dosimeters employing charcoal were “validated” against monitoring methods employing charcoal in a pump fed tube.
Since passive dosimeters employed charcoal, they were comparable to the tube method, but both methods were inaccurate and unacceptable and were known to result in consistently underestimated results at least since the Vinyl Panel investigated their use in 1974.
9/4/79
At least by September 4, 1979, and probably earlier, the MCA was actively exploiting the “safe” experts they had been cultivating at the UOL since 1975 for use as experts to testify for the MCA-coordinated vinyl manufacturers against persons claiming to be injured as a result of exposure to vinyl chloride.
9/20/79 [78]
On September 20, 1979, the VCRC met at Room 404 of the CMA Offices in Washington, D.C. to discuss a recently completed European study.
The “CIVO” study discussed at this meeting was a European industry-sponsored study that ICI (Bennett) obtained through confidential channels. Although the CIVO study showed that laboratory animals fed PVC powder developed cancer at levels the MCA-coordinated vinyl manufacturers were told were far lower than shown by any previous study, of course, such findings were subject to confidentiality agreements and so were not revealed publicly.
The VCRC also received a report from Dow about Dow's recent visit to Dr. Maltoni in Italy. Dr. Maltoni said that his "final" report (the quotation marks are in the original), based upon all the research he had performed for industry since 1971, might soon be published.
The group asked Dr. Tamburro (University of Louisville, or UOL) if they had any reason for concern over the Texas City incident.
In response to their concerns, Dr. Tamburro reassured the members that not only were there no ongoing studies at UOL relating to brain tumors, the Panel could rest assured he scarcely could imagine any way such a study might ever be conducted at the UOL under his direction
In fact, neither the CMA nor the SPI would sponsor any type brain cancer study until from around 20 years later in 1995, after the CMA and most of the CMA-coordinated vinyl manufacturers were named as a defendant in the Ross litigation in Lake Charles, LA. In 1995, Dr. Tamburro did conduct a study of brain cancer for the American vinyl industry. A case control study involving the brain cancers in the TCA study would never come, however.
Dr. Carlo Tamburro, an undistinguished but apparently businesslike and personable scientist from the UOL, performed a case control study of BFG Louisville workers. The Tamburro case control study used a so-called parametric system to classify exposures, this being something of the undistinguished author’s own eccentric if not unfounded design.
Interestingly, Dr. Tamburro was the same UOL scientist who in 1980 had said he could not foresee a study that was relevant to brain cancer ever being conducted at the UOL under any foreseeable circumstance.
Tamburro submitted a bid to the CMA, though not at CMA’s request; and the bid was not being submitted in the ordinary course of any academic procedure, or even as a normal unsolicited bid. Instead, Dr. Tamburro’s bid was at the specific request of outside counsel defending PPG, Inc, in ongoing brain cancer litigating allegedly involving VCM exposure in Louisiana, and in New York. (Along with Dow, BFG, and Goodyear, Conoco, and Vista Chemical.)
Tamaburro had predicted three specifically favorable results when he submitted his first pitch for the six-figure contract.
The three hypotheses Dr. Tamburro predicted for his potential sponsors would be confirmed by his new parametric exposure ranking system were as follows: (1) No relationship between exposure to vinyl chloride and the development of brain cancer existed at all, (2) If a relationship existed at all, there was probably a meaningful threshold, and (3) If there was a threshold, the threshold was very probably 50 ppm.
Tamburro claimed he was able to confidently assure the CMA (Shah) could in fact be conducted without risking that anything untoward might happen. If Dr. Tamburro lived up to his commitment, there was no way the sponsors could loose.
The VCRC received the Audit Task Group’s preordained conclusion that the IBT studies had gross, irreparable deficiencies.
However, the pretext for not continuing the audit was that little could result from examining the, still unexamined, records and research materials equally important as the ones the Group had taken the time to examine.
In an almost unprecedented gesture, Dr. Zeb Bell from PPG was the only vote against the immediate cessation of the respective auditing of the IBT data, especially since the group recognized that the unexamined data known to still exist was recognized at least as valuable as what had been examined.
Dr. Bell specifically requested that his negative vote be recorded. However, as in every other case in which a company on the Vinyl Panel was outvoted, that company nevertheless went along with the rest of the group and respecting majority decision, and, despite D. Bell’s expressed reservations, neither Bell nor PPG did anything more about the IBT data than any other member.
Next, the VCRC specifically assured the Group that Dr. Tamburro, at least, wasn't about to do anything as risky or potentially dangerous as studying brain cancer, the VCRC went on to discuss the situation that had developed at Texas City.
Three vinyl companies represented by the Vinyl Panel[xviii] (Dow Chemical, Union Carbide and Monsanto) had been recorded to have excess brain cancers and an intense investigation was underway. However, the data provided to the government investigators was not the same data as had been used in previous studies, including studies of the vinyl workers. As a result, unexposed workers were identified and exposed workers were NOT, i.e., Union Carbide was able to assure the Group that it could, in some respects, control the findings of the government investigative report of the Texas City cancers, which was, after all, almost necessarily reliant on the different companies providing honest information about vinyl exposures, membership in prior studies, job titles, etc.
The end result was that the Panel was allowed to exercise effectively the same type of control over the outcome of the Texas City studies as they had less subtly exercised over the TCA cohort.
Not only did the Group influence the findings of the government report by controlling the population that would be included in that report, they were also able to prevent the disclosure of their own misconduct with regard to their prior reclassification and exclusion of workers at the original TCA cohort was defined,
The CMA Group all knew that their IBT audit report contained significant gaps in the chronology of the IBT research program they purported to describe, an extremely significant example of which, as previously mentioned, was Group's own authorization of Dow Chemical to remove significant numbers of animals from the study in order to complete the politically/motivated cytogenetic studies the industry thought it needed to "combat" allegations that vinyl chloride caused genetic damage, as suggested by independent studies conducted by doctors at the Mt. Sinai hospital in New York.
Although the group recognized that leaving such gaps in their chronology of IBT events would pre-expose them to undue and justified criticism, they did anyway because they also knew that an audit description of those same gaps would most certainly have led to well deserved and completely justified criticism of that same study, when the corrupt manner in which the Panel had controlled, administered, deliberately compromised, and suppressed the IBT studies were revealed.
Dr. R.N. Wheeler from Union Carbide reassured the Group that the early emphasis on vinyl chloride as the potential cause of the Texas City brain cancers was shifting to a study of the entire area, and not simply vinyl chloride alone. Wheeler went on to reassure the Group their was still no evidence the government could use to prove vinyl chloride had caused the glioblastomas at the three vinyl plants in Texas City.
The Panel was also advised of an outright horrifying report by Dr. Stafford from ICI concerning the results of a recent epidemiologic study of 118 PVC workers at ICI’s Hillhouse facility in Blackpool, England.
Although every member of the Panel knew that they were under a legal obligation to report to the government any significant report they received of adverse health effects associated with vinyl chloride, and whether they believed them or not, none of the member companies ever reported what they learned at this meeting and confirmed at subsequent meetings.
The ICI study (at least prior to its publication) had demonstrated statistically significant decreases in lung function across the board, including decreases in other systems as well.
The significance of this finding was made apparent by the group's characterization of the degree of lung damage caused by exposure to PVC as being the equivalent of smoking twenty cigarettes per day. Additionally, evidence of pulmonary fibrosis was discovered among the cohort.
This study would not be reported to EPA by any of the CMA-coordinated vinyl manufacturers under TSCA 8(e). Instead, as will be shown, the Group knowingly submitted the ICI study to a low-level government employee they had reason to believe would not take any significant action or, most likely, even appreciate their "FYI / CYA submission," and would, instead, deliberately fail to make a report of this significant adverse health effect under TSCA(e) – the cynical and utterly false rationalization for this illegal conduct was that a report of a PVC related effect on lung function equivalent to smoking a pack of cigarettes a day was, in their "interpretation" not significant.
This "interpretation" was self serving and made under a false pretext since every member of the Panel was well advised and knew full well at the time the decision was made for them to collectively forego their acknowledged legal obligations under the Toxic Substance Control Act.
By the time the study appeared in any form that was available to the general public, it found discrete effects caused by PVC dust, but the observation of the universal effect on lung function equivalent to smoking a pack of cigarettes a day was completely absent.
Instead, as planned at this meeting, the U.S. and European manufacturers decided to meet in November of1979 for the specific purpose of covering up the disturbing (and, if widely appreciated, potentially extremely costly) findings the secret European dust study had shown.
By throwing in new information and new methods of analysis that called for in the original protocol for a study such as the interaction of age, smoking and other factors, the specific purpose of diminishing the perceived significance of the report's original findings of a discrete and separate decrement caused by exposure to PVC dust per se was accomplished.
The vinyl manufacturers themselves recognized (in secret) that the detrimental effect on lung function was on the order of smoking twenty cigarettes per day.
PVC dust per se caused statistically significant detrimental lung function, evidence of pulmonary fibrosis, as well as, including a decrease in FVC in lung function even the industry recognized was the equivalent of approximately twenty cigarettes per day.
In addition to agreeing to collaborate with the Europeans in their scheme to intentionally misrepresent and diminish the perceived significance of their original findings with regards to the adverse effect of exposure to PVC dust in and of itself, the Group agreed to consider conducting animal studies as well as including an investigation of the effects of PVC dust in the still ongoing "extended EEH study." However, well aware of the serious risks and likely adverse economic outcome an animal study might have, the Research Coordinators rejected the idea of animal studies, out of hand.
Similarly, once the troublesome ICI study was "fixed" by altering the protocols of the troublesome ICI study so as to include – years after the fact and at the last minute – information on smoking, age, etc., which additional data was not put in the original study and which analysis was not included in the original study either, but was, instead included solely in order to litigate the unfavorable findings the suppressed the original ICI study had contained (a report that was then suppressed through the mutual cooperation of the Europeans and the Americans).
The VCRC was informed, if they didn't already know, that EHA wasn't even able to prepare a real bid for the five-year update of the original TCA cohort (which would have covered the time between 1973 and 1979) because they didn't even know whether the records they were supposed to use were complete, what was in their record archives from the TCA study, and if all the original raw data was still available.
Although EHA explicitly and, over the next several years, would repeatedly emphasize their inability to even make a bid to conduct a study without knowing such fundamental things as how many individuals were supposed to be in the cohort or the nature of the raw data available, as will be shown, the Panel and EEH managed to find a way to conduct the study without ever reviewing the deficient database that was considered so severely deficient by EEH that it was unable, even, to prepare an estimated cost of conducting the study.
The deficiencies in the underlying database were never corrected, and were, in fact, deliberately never assessed by anyone prior to the commission, and even completion, of the work the CMA Group asked EHA to perform over the next six years.
The "solution" the CMA Group came up with was for EEH to simply analyze whatever data the sponsors provided them with EHA paid on "per head" basis, despite the fact that the number of "heads" that actually would end up in the study population was completely unknown, but well recognized to be far in excess of the number of workers previously identified in the grossly diluted and incomplete cohort the CMA Group had previously assembled.
As will be shown, instead of having to bid the entire contract, the MCA decided, and EHA agreed, to break the study into two parts. First, EHA would collect the data as per the vinyl manufacturers investigation, without any commitment to analyze the data at all.
Instead, and in an ad hoc procedure that was so "innovative" that neither the CMA Group, nor EHA, ever saw fit to honestly describe it anywhere, the Group had reason to think the public might discover it, including the description contained in the eventual reports on how the study was conducted, materials and methods, etc.
The intended purpose for this unprecedented (and completely undisclosed) derogation from the previous protocols and, indeed, from the standard methods employed in conducting epidemiologic studies in general give the CMA Group control over the study’s findings, i.e., to preclude incriminating vinyl chloride.
The CMA Group decided that EHA should modify its proposal to not only identify the companies involved in the study but also which particular plants from those companies were included in the proposal.
Although the CMA Group admitted among themselves that they didn't, even in 1979 after receiving no less than nine previously final reports from TCA, and EEH, know which plants were included and which were omitted from the EHA / EEH cohort or why such modifications to the cohort took place.
As a result, the companies were certainly aware that the cohort as presently defined was incomplete to a degree that they could only imprecisely estimate. Their situation needs to be considered when evaluating the CMA Group's conduct in the years to follow:
The CMA Group chose not to even try and figure out how may workers and how many plants had been improperly included in the original study and how many had been improperly excluded from the study, and, further, leaving the completely unquantified bias and source of error in the study concealed and unknown.
The incompleteness of the cohort, and the improper inclusions of workers who did not belong in the study and its improper exclusions of workers who did belong in the study, weren't even referred to in any of the new "final reports" to follow-up that the CMA Group never revealed, deliberately deciding, instead, to analyze and present the cohort data as reliable.
The Panel requested the participating plants to quantify dust exposure and consider whether exposure to EDC should be considered in the study that 95% workers exposed to VCM were exposed simultaneously to EDC.
The Panel also voted to obtain a case control study from EHA of the brain cancers they had already identified over the last six years, even in the extremely biased and diluted cohort they had assembled during that time.
As will be shown, and as might be expected, no such study would ever be performed as a result of the CMA Group's deliberate decision that it not be performed after the Group realized that they could never succeed in their thus far most successful efforts to conceal the strong evidence of the relationship between vinyl chloride exposure and the development of brain cancers.
The CMA Group knew that the even the grossly compromised studies that they had previously conducted had well demonstrated an association between exposure to vinyl chloride an excess in brain cancer mortality.
The brain cancer case control study the CMA Group voted to perform at its September 20, 1979 meeting, as well be shown, would be rejected precisely in order to conceal the relationship between brain cancer and vinyl chloride.
Having used the pretext that the NIESH "vinyl committee" had advised the group not to conduct the studies to determine whether a single exposure to vinyl chloride could result in cancer, the CMA Group, as previously shown, succeeded in completely precluding any studies (including those they had made a public commitment to conduct) that might result in a positive finding that might confirm similar studies they knew were then going elsewhere,
The VCRC voted to engage in an outright attack on the CPSC study, whose design they had been free to criticize for years, and the so-called lack of interest on the part of the CPSC study had been used as a reason for the CMA to abandon its own research program along similar lines (for the incredibly cynical reason that the presumably well done CPSC studies had made the similar studies the CMA Group had announced and committed to perform redundant, unnecessary and a waste of precious funds available for scientific research.
Dr. Jessie Norris from Dow Chemical was requested to prepare the criticisms of the CPSC study on behalf of the CMA-coordinated vinyl manufacturers.
The CMA Group had deliberately chosen not to duplicate through studies of their own, as they had previously announced.
CMA attorneys were given responsibility for obtaining documentation on the CPSC studies that the Group had already decided they would attack on what appeared to be scientific grounds, but which were, in fact, concerns based entirely on the mutual financial interest of the sponsoring companies of the MCA-coordinated companies, and for diminishing the perceived significance of the CPSC study.
The Research Coordinators agreed that all records of their meetings should be sent to all of the original sponsors of the IBT study as well as the original epidemiological study conducted by TCA, without regard to the level and extent of participation the various companies had taken in the more recent activities of the MCA or the Vinyl Panel.
On September 20, 1979, the VCRC decided that the workers that would be subject to this "new" study by EHA using data laundered from TCA and EEH would not go beyond the workers identified in the previous studies, but that there assessment the available records would form the basis for any at all bid requests.
9/20/79
At the CMA Vinyl Chloride Research Coordinators meeting, held on September 20, 1979, Mr. R.N. Wheeler (Carbide) submitted a brief update on the Texas City tumor incidence and concluded his presentation with the opinion that it will be a least a year before anything definitive appears possible.
Wheeler assuaged the fears of the CMA Group by relating a perceived shift in the emphasis of the government’s study to a study of the entire area. At this point in time, there was no evidence that indicated vinyl chloride induced the formation of glioblastomas. Mr. Wheeler called attention to the fact that the same kind of study (a joint Carbide, OSHA, and NIOSH investigation) was just beginning at Carbide’s South Charleston, West Virginia plant.
9/28/79
On November 28, 1979, the VCRC discussed, again, the so-called "extension" of the MCA / CMA's basic study they had been adulterating for years into a so-called five-year update. (A five-year update which, has previously foreshadowed, would never published, and no five-year update would be published until thirteen years later.)
The Panel planned to conduct a case control study of brain cancer in the existing cohort as a prerequisite for the five-year epidemiologic update and considered an evaluation of the data that had been archived by EEH by the CMA Group's current so-called independent contractor to, in effect, "launder" for MCA, analyzing the data according to methods dictated by the sponsors and most importantly without asking too many questions about where the data came from in the first place.
The Panel received information that the cohort data that had been archived by EEH and that was now to be "laundered" by EHA was stored at the old Rockdale, Maryland offices of EEH and consisted of files and computer cards for each cohort member as well computer printouts of study analyses, and printed correspondence with participating plants.
The VCRC made the decision whether to report the IOM findings relating to PVC dust lung disease would not be reported accept by the joint agreement of lawyers for CMA's general counsel (Ed Frost) and SPI's counsel (Mr. Joseph Hadley) after consultation with the Panel.
As will be shown, the assessment of the raw data used in the previous studies showed that, as obviously deficient and biased as the underlying data was, it would still not serve to obscure the relationship between brain cancer and vinyl chloride exposure, the group dropped the brain cancer study they had voted and authorized funds to perform.
A similar concern with regard to the five-year epidemiological update led to a similar corrupt concern, and no five-year, or any other update, would appear in the open literature until at least 1991, and even then the sponsors would claim that this unexpected publication amounted to a breach of contract on the part of the contractor who used his "right" to publish the update study (over a decade after it was begun and over five-years after it was completed).
9/29/79
By September 29, 1979, the CMA-coordinated vinyl manufacturers, unquestionably, had formulated a specific plan to conduct a brain cancer case-control study. The study was supposed to involve the twelve present brain cancer cases that had managed to make their way into the 10,173 workers in the “augmented” cohort involved in the 1978-era studies conducted by EEH.
As a preliminary step for the five-year update, the Vinyl Panel agreed to pay EEH to begin an assessment of the raw data that was supposedly underlying the previous TCA and EEH reports.
The Panel was informed that a proposal for an epidemiologic study involving PVC dust had been solicited by the CMA from the University of Tennessee Center for Health Sciences (UTCHS). However, even knowing what the sponsors knew about PVC dust, the sponsors, again, agreed to completely forego toxicologic studies. However, the group claimed an intention to study the effect of PVC dust on American vinyl workers in the course of the forthcoming update to be conducted by EEH.
None of the studies of PVC dust the MCA or CMA ever considered, or committed to perform, however, were ever, in fact, performed. None of the workers involved in the forthcoming EEH, EHA or ENSR studies would ever be examined for adverse health effects potentially associated with exposure to PVC dust in any industry-sponsored study.
11/28/79
On November 28, 1979, the CMA, Vinyl Chloride Research Coordinators (VCRC) [79] met and discussed the proposed IBT settlement, a soon to be suppressed version of PVC dust study, and the extension of the extension of the EEH / EHA epidemiologic study.
On November 28, 1979, Dr. William Adams from ICI reported from an internal study conducted at Vinatex (a Conoco venture in the UK) and informed the VCRC and the entire CMA Group of the attempts that were being made at Vinatex to attempt to correlate vinyl chloride exposure with coronary disease.
Although the public persona of the CMA program was so very concerned about "early detection," the VCRC deemed it necessary to balance the abysmal record of the study of vinyl chloride disease the CMA Group had intentionally cultivated with detecting and acknowledging the existence of vinyl chloride related disease, even when it was not a question of detecting vinyl related disease early in the course of its development, but a question of detecting and acknowledging vinyl chloride adverse health effects they very well knew were occurring in their workers without their workers' knowledge.
In such a circumstance, it shouldn't be necessary to take protestations of concern for "early detection" very seriously, especially when offered by entities like the University of Louisville (UOL) and the CMA organizations that historically refused, in the face of mountains of evidence to the contrary, to deal honestly with anyone any of the several varieties of vinyl chloride related disease.
11/28/79
The Research Coordinators recommended on 11/28/79 that their records of meetings be sent to the “original” thirty sponsors of biological research programs and to the sponsors of the original epidemiological study.
The settlement was to be proposed by IBT Counsel within the next several weeks and was to be sent first to the Vinyl Chloride Audit Task Group (ATG).
After taking the action required, the ATG was to send their recommendations to the Research Coordinators. The Research Coordinators would then, in turn, prepare recommendations to be submitted to the Panel.
Drs. John Stafford and William Adams of ICI, England presented the findings and conclusions of the ICI study that the Institute of Occupational Medicine (IOM) in Edinburgh had conducted using workers from ICI’s Hillhouse plant in Blackpool, England.
This prestigious research organization made it crystal clear to ICI in the very beginning that, although it was sponsoring the study, ICI would have no voice in the conduct of the study at any point. IOM also made it clear that the study would be conducted primarily for the benefit of the industrial worker.
The ICI study cohort consisted of 818 men selected from the present and past work force of a plant manufacturing polyvinyl chloride (PVC) were studied to determine whether PVC dust caused any measurable effects.
Respiratory symptoms such as cough or breathlessness and the results of breathing tests and appearance of the chest x-rays were compared with estimates of the amount of fine PVC dust to which each man had been exposed during his employment at the plant.
When studying the effects of PVC dust, allowance was made for the known effects aging, smoking, and physique on the lungs, it was found that men who smoked cigarettes and who had also been exposed to higher amount of PVC dust reported slight shortness of breath on exertion more often than smokers who had been exposed to lower amounts of dust. The study associated this symptom more strongly with aging than smoking.
The dust effect was not seen among non-smokers and ex-smokers.
The ICI study did not associate exposure to PVC dust with chronic cough or sputum production (chronic bronchitis), acute chest illnesses, acute bronchitis, pneumonia, plurisy, or asthma.
However, the ICI study found a relationship between exposure to PVC dust and the complaint of breathlessness when hurrying on level ground or walking up slight hill, but this relationship was found only in cigarette smokers and not in non-or-ex-smokers.
One of the three experts detected small, round opacities more commonly in the radiographs of men with higher exposure to PVC dust than in those with lower or no exposure. The other two readers did not detect an effect of PVC dust although they observed small, round opacities in a few cases. The opacities seen by these readers were not more common in those with higher exposures to dust than those with lower or no exposure. However, the prevalence of small, round opacities was not related to the presence of chronic cough or sputum, or histories of chest illness.
The IOM report concluded with its opinion that the effect of PVC dust inhalation on lung function was of the same order of magnitude as that of cigarette smoking, and, approximately one-seventh that of aging.
The Research Coordinators of the vinyl chloride Panel recommended that ICI should submit the Edinburgh ICI dust study to NIOSH. (Significantly, however, this recommendation was contingent on subsequent advice given to the ICI by ICI Americas’ legal counsel in Wilmington, Delaware.)
The Chairman of the CMA Vinyl Panel and Research Coordinators, Dr. T.R. Torkelson, appointed Mr. R.N. Wheeler to prepare a summary statement containing salient findings presented in the IOM report. Thereafter, Mr. Wheeler forwarded the report to SPI and to the Project Administrator.
Upon receiving Wheeler’s report, the Project Administrator sent it immediately to CMA’s General Counsel who, in turn, collaborated with SPI’s Counsel (Mr. Joseph Hadley) on the preparation of the final statement.
After joint agreement of SPI and CMA counsels, the document was sent to the Research Coordinators for their approval. After the Research Coordinators approved the document in final form, it was to be distributed to all Panel members.
Dr. Torkelson presented a status report on preparatory work in progress. His review included the document recently prepared by the Project Administrator, entitled “Specifications on which Proposals and/or Bids are to be Based for a Five-Year Epidemiological Update on Vinyl Chloride and Critique on Factors Relevant to the Study.”
These bid/proposal specifications emphasized that an evaluation of data currently being archived by Equitable Environmental Health, Inc. (EEH) is a necessary prerequisite to both the “brain study,” should it be conducted as a separate entity, and to the larger investigation, the five-year epidemiological update. The epidemiological update would extend from December 31,1972 to December 31, 1977. An effort would be made to determine the vital status as of December 31, 1977 of the eight thousand nine hundred and seventy cohort members who were determined to be alive on December 31, 1972. An attempt would be made to determine the vital status of the four hundred and ninety-six cohort members who were lost to follow-up during the previous study.
Efforts would be made to retrieve death certificates for cohort members identified as deceased based on the follow-up effort. The complete study population would be analyzed using the expanded life table program, for example, Monson’s program (Harvard) or Enterline’s Program (University of Pittsburgh).
After deliberating on factors relevant to the brain study and to the overall epidemiological update the paper the VCRC requested funds to: (1) conduct a study or assessment of the data currently in storage at EEH, (2) conduct the brain cancer case control study, and (3) begin preparation of for a protocol for the five-year epidemiological update.
Dr. William Adams reported on a study conducted within the Vinatex Group in England. This research was an attempt to correlate dose-related VC exposure and coronary disease.
Following Dr. Adams' review, Dr. M.N. Johnson was to follow-up with Dr. Tamburro (Director of Research at the University of Louisville) on observations made by Dr. Tamburro and his associates on triglycerides and their possible relationship with VC exposures and coronary incidence.
At the request of the Panel Chairman, Dr. T.R. Torkelson, Dr. J.M. Norris evaluated the final report issued on the so-called Edgewood Arsenal “Single-Hit Study” sponsored by the Consumer Product Safety Commission (CPSC) under an inter-agency agreement with the Chemical Systems Laboratory (formerly Edgewood Arsenal).
Dr. Norris reported that the final Edgewood report contained the same deficiencies as the draft report.
Dr. Torkelson, Dr. Hatfield, and Mr. Wheeler were to pursue additional data on the respective study categories. CMA's action, then, was contingent on the results of the efforts of these men.
Dr. David Duffield reported how angiosarcoma had been officially declared “over-diagnosed” in England when an expert panel of pathologists in England had "thrown out" (invalidated) the readings on about on half of the slides on which angiosarcoma diagnoses had been based.
The action of these expert pathologists resulted in the number of angiosarcoma cases in England during a five-year period being reduced, leaving only one or, at most, two on the registry at all.
11/28/79
On November 28, 1979, the VCRC reviewed the so-called angiosarcoma registry maintained in England by Dr. John Stafford at ICI, Ltd.
Although the deposition of a dying thirty year old man whose first exposure to vinyl chloride had come as an extrusion operator in a bottling plant had been involved in litigation beginning in 1986 in which the uncontested evidence was that Mr. Cox had worked only six years as a extrusion operator.
The named defendants in the Cox case paid this young plaintiff over $500,000 without much of a contest and required that secrecy agreements be signed. None of the companies involved in this incident ever reported the occurrence of this cancer in a worker who first entered the vinyl industry after 1974, this worker who had worked not in the PVC or VCM industry directly but only as a fabricator in a bottle plant.
None of these companies ever reported Mr. Cox's angiosarcoma to the ICI angiosarcoma registry, or if they did, did so only with the understanding that the case would not be published in ICI's registry, but instead would be maintained confidentially in a separate file by ICI and concealed from the world for all time if possible.
On or about November 28, 1979, the CMA Group learned of an upcoming symposium to be conducted by various agencies of the federal government, and which had resulted in the publication of a formal request for information on behalf of federal agencies of the United States Government for any unpublished information on adverse health effects associated with vinyl chloride exposure, in anticipation of the upcoming symposium, and, perhaps, regulation.
Despite what one might think from what the MCA said about the Government's conference to reevaluate the carcinogenicity of vinyl chloride in its structural analogs in the future, every member of the Vinyl Panel knew that CMA’s, in general, and the Vinyl Panel’s, in particular, participation was specifically invited by Dr. Peter Infante of NIOSH.
As will be shown, the CMA Group's decision was to continue to conceal the unpublished reports they had received from the at least nine undisclosed reports on their own workers they had received over the course of the last six years (to say nothing of the many reports from other sources that the group had held secret even from their own government) the CMA Group would decide to submit only those few final reports, numbering two, that they had already submitted to the government on previous occasions, without more.
Further, the presentation made by Dr. Cooper at the conference to reevaluate the carcinogenicity of vinyl chloride monomer was, whatever Dr. Cooper may or may not have thought, an act of fraud perpetrated by the Vinyl Panel since the subject of the report was none other than the ninth "final report" the MCA / CMA had received since 1975 on exactly the same group of workers.
The report that Dr. Cooper presented was based on a so-called EEH report that had been progressively sanitized in a series of at least eight reports and modified elsewhere too.
The VCRC took special effort to make sure that all the original thirty sponsors of the IBT program and that all the members of the TCA epidemiological study be brought up-to-date as to the developments that had recently occurred with regard to PVC dust, liaison with NIOSH, the brain cancer investigation, the state.
Discussed by the VCRC were the following: The unknown state of the raw data from EEH, the so-called "final" decision to conduct a five-year update, the information relating to vinyl chloride exposure in coronary disease and observations relating to triglycerides and their possible relationship with VC exposures in coronary incidences, the plan to launch an attack against the CPSC Edgewood Arsenal Study demonstrating the occurrence of excess lung cancers in animals with a single exposure to two hours of vinyl chloride in a "single hit study" almost exactly like the one the CMA Group had publicly announced it would conduct but, aborted after learning of the CPSC study, although under a pretext (that the soon more or less abandoned) that the NIEHES "Rall Committee" had suggested they do so, etc.
The VCRC learned of the great success that ICI had obtained in England having their expert Panels "throw out" over half of the slides on which angiosarcoma diagnosis had been based, thereby promptly reducing the perceived risk posed by vinyl chloride by 100% .
11/28/79
VCRC November 28, 1979 meeting had been planned a little over two months earlier at the September 20 meeting. In attendance were both the VCRC and their European counterparts. The subject up for discussion was what to do about the report in the recent ICI report indicating, among other things, an adverse effect caused by exposure to PVC dust that was estimated to be the equivalent of smoking one pack of cigarettes per day.
In the course of explaining how ICI had come to put the CMA Group in another situation in which they were going to have to violate some very serious laws in order to comply with their former and mutual secrecy agreement they had broken in the early 70s.
That law specifically referenced and discussed and included the right to reveal all the manufacturers knew in response to questions from regulating agencies or authorities, but also clearly would include civil lawsuits, environmental warnings, product information, etc.
Shawn Stafford and William Adams from ICI, England presented the VCRC with a thorough review of the ICI study that already had every member of the Vinyl Panel in undeniable violation of TSCA(e) approximately two months before this meeting, and, at most, ten days after the November 20 VCRC meeting when the group received reports from reliable sources that they routinely relied upon almost literally without question that the exposure to PVC dust, becoming apparent in the PVC industry, caused adverse health effects. The CMA Group, however, minimized and even denied this hazard existed since the time they first found about it sometime prior to1974.
Shawn Stafford and William Adams from ICI described how ICI had been forced to put the CMA Group in this "embarrassing" illegal position.
The VCRC acknowledged (and, like everything else the VCRC did, communicated it with the Panel through the transmittal of minutes and memoranda) that the health problem demonstrated by the IOM study ICI had sponsored, in direct contradiction to what the same group would tell itself "for the record" in a short time when it would attempt to rationalize their failure to file a TSCA(e) report upon their firm belief that the condition that caused and effect on lung function the equivalent of smoking a pack of cigarettes a day, and worse, was not a significant or serious adverse health effect, was, in fact, somewhat of a problem insofar there were no other studies with enough significance to discredit PVC dust as an etiologic agent for vinyl chloride disease.
The ad hoc plan the Research Coordinators had thrown together the previous September 20 included an issue with additional analyses of aging, smoking and such as that, but the VCRC learned that was not going to be as easy as they thought because the original study design had already made allowance for the known effects of aging, smoking, etc.
The prospective used to rationalize the CMA Group's forthcoming submission of the IOM PVC dust report was due to: (1) TSCA(8)(e) requires only reporting serious and significant adverse health effects, and (2) that the report the group had received that the effect of PVC dust exposure was equivalent to cigarette smoking supposedly was not a report of serious adverse health effect.
The recommendation, at least for the record, that ICI submit the IOM report to NIOSH, however, did not absolve the CMA Group from reporting under the Toxic Substance Control Act (TSCA). (But, as they had done so many times in the past, The CMA Group shirked their reporting responsibilities as American corporations doing business in, and subject to the laws of, the United States to ICI, a foreign corporation from Great Britain.
The CMA Group acknowledged the ultimate authority on whether the startling ICI reports on the toxicology of PVC dust would be reported to government, the only party who would ultimately decide whether the startling results group had received from ICI on PVC dust would be reported to the U.S. Government was ICI - and not any American company.
The VCRC agreed that the ultimate determination as to what, if anything, NIOSH would be told about the secret IOM report, would be dependent upon advice the ICI representatives received from legal counsel in Wilmington, Delaware.
The "legal advice referred to in the previous paragraph" was in fact not provided by ICI, Ltd., from British lawyers or even lawyers employed by ICI itself.
The SPI and CMA worked together in sanitizing the IOM results, in delegating Union Carbide's Mr. R.N. Wheeler's responsibility for summarizing a sanitized statement of the IOM findings. This summary statement was understood by the CMA Group to be circulated among themselves without regard to whether the particular committees were formerly denominated as SPI or CMA projects.
Everybody on the Panel knew that whatever skills Mr. Wheeler may have had as a result of his own past experience concealing the adverse health effects of vinyl chloride, he had no reasonably sufficient or colorable education that would allow him to discern salient points contained in IOM report furnished to SPI, to CMA's general counsel, and then from CMA's general counsel to SPI's general counsel, Mr. Joseph Hadley, who would prepare the final statement which, after joint agreement, SPI and CMA lawyers would send to the MCA / CMA Research Coordinators, approved by the Vinyl Panel, and distributed to the Vinyl Panel [and then sent it to Government].
11/28/79
At the time of the November 28, 1979 VCRC meeting, the VCRC shared its information and documents with the CMA Vinyl Panel at large, both the technical representatives and their management contacts, as well as others known and unknown concerning a Conoco plant (Vinatex) in the U.K. where serious cases of vinyl chloride disease (acroosteolysis) had been, and continued to be, shown to exist.
This was of concern as the MCA-coordinated group of vinyl manufacturers had suppressed the 1969 UOM report, which had found vinyl chloride caused acroosteolysis, and defined the disease out of existence, declaring it extinct,
Dr. William Adams told the VCRC that triglycerides might be useful for early detection of liver injury, or the mechanism of injury, and Dr. Maurice Johnson from BFG agreed to follow up with Dr. Tamburro with the possible relationship of triglycerides to both vinyl chloride and heart attacks.
This information has never been published by the University of Louisville, nor revealed by the companies involved.
In connection with the reference to triglycerides in the previous paragraph, consider the CMA Group's previously demonstrated suppression of its own studies relating to cardiovascular disease as well as their demonstrable record of literally going out of their way to avoid addressing the long recognized (1930s) adverse effect on the heart (cardiac sensitization was the reason VCM was eventually rejected in the 1930s as an unsuitable gas for anesthesia).
The CMA Group had long openly discussed the logical likelihood that a gas that could cause systemic sclerosis of the cardiovascular system as a component part of vinyl chloride disease, with its most famous target being capillaries in the fingertips and feet of PVC workers - something that was openly discussed in confidence among the CMA Group.
For example, the UOM had expressed to the PVC manufacturers and to the MCA Occupational Health Committee their concern about the ramifications of their (soon to be suppressed) findings with regard to acroosteolysis might have for cardiovascular disease.
The VCRC, led by Jesse M. Norris from Dow, did his level best to blow holes into the CPSC study indicating that a single two hour exposure at 10,000 ppm could result in excess lung cancers in animals held for two years thereafter, even without any further vinyl chloride exposure.
As part of an experiment to simulate the potential effects of a railway spill of vinyl chloride resulting in a single exposure, as previously shown, the CMA Group had abandoned its own near identical studies at the last minute - even having to pay for seventeen weeks during which IBT supposedly was holding the cages empty but with rats at the ready while the CMA Group tried to go through the pretext of getting advice from the NIEHS to immediately discontinue these publicly announced studies, without the NIEHS knowing it, before deciding, about thirteen weeks later after the group had not been able to even meet their own sorry standards, they abandoned even the pretense of a pretext and just went ahead and killed the study anyway, with no more than some sort of "vague raw committee" gloss that no one on the Panel was very likely to question being as how the whole Panel knew the entire raw committee thing was a pretext anyway.
The bad faith submission of the high fluting sounding sanctimonious criticisms of the "one hit" theory in the single exposure study conducted by CPSC at the Edgewood Arsenal never included any reference to the Rall committee, or to the MCA studies that had been abandoned, or the reasons therefore, in any of the criticisms leveled against the CPSC study at Edgewood Arsenal submitted by members of the CMA Group.
12/5/79
On December 5, 1979, MCA (Seawell) advised the MCA-coordinated vinyl manufacturers[80] that ICI (Dr. John Stafford) had informed CMA of how it had handled the report, entitled “An Epidemiological Study of Respiratory Disease in Workers Exposed to Polyvinyl Chloride Dust.”
This same study of workers at ICI’s Hillhouse Works in Blackpool, England, had been characterized by both ICI and the MCA-coordinated vinyl manufacturers as indicating a detrimental effect on lung function caused by exposure to vinyl chloride thought to be roughly comparable to smoking twenty cigarettes per day.
The agent and representative of ICI, Ltd., in the U.S. was ICI Americas (Zeneca Inc.).
The ICI Americas legal staff in Wilmington, DE, was reported to have reviewed the IOM report thoroughly in order to assess whether the ICI report constituted a report of a serious adverse health effect for purposes of the reporting requirements imposed by Section 8(e) of the Toxic Substances Control Act (TSCA).
Incredibly, the cynical “legal opinion” of ICI’s legal staff was that the same findings ICI had reported was roughly the equivalent of smoking cigarettes, did not pertain to “substantial risks,” and, therefore, was not a reportable event within the intent of TSCA 8(e).
This “interpretation” was made in utter bad-faith, however, and with a purpose to defraud the U.S. government, and every member of the Panel (who had their own TSCA 8(e) reporting obligations) can only have known it.
The Vinyl Panel was told that ICI Americas did not intend to file the document under Section 8(e), and the companies represented on the Vinyl Panel didn’t report it either.
The Vinyl Panel learned that the CYA (Cover Your Behind) scheme the ICI legal staff had in mind called for ICI’s representative on the Vinyl Panel to submit the IOM report to NIOSH as an FYI (For Your Information) submission and not as a TSCA 8(e) submission, and, specifically, that the submission be made only after the representatives return to England.
A copy of ICI’s letter of transmittal was to be forwarded to CMA.