1/15/80
On January 15, 1980, Environmental Health Associates, Inc. (EHA, the successor to EEH) wrote the Vinyl Panel through CMA (Joseph T. Seawell) proposing to conduct an epidemiologic study (case control) of the brain cancer cases as well as the 5-year follow-up the MCA-coordinated vinyl manufacturers had made the commitment to perform.
Information available to EEH indicated that the 12 brain cancer cases identified in previous studies had come from only four or five separate plants.
EHA required assistance from CMA in order to identify a contact person at each plant who was to be responsible for expediting EHA requests for information regarding the brain cancer cases. EHA proposed to obtain copies of the following files for each case: Company medical file; Company personnel file; Company of Insurance carrier Workers’ Compensation file; with additional information on work history, previous employment, hobbies, etc., obtained solely from supervisors or fellow workers of the deceased brain cancer victims; Pertinent medical history from personal physician; and Surgical and/or autopsy histopathology results.
Whenever possible, the information necessary for the brain cancer case-control study was to be obtained from sources, which could be openly identified in a subsequent report. Where the information was obtained on a confidential basis, no source citation was to be provided. Entirely at CMA’s option, EHA would contact the deceased’s family for additional details. However, this would be decided on a case-by-case basis in consultation with the company involved.
In language taken directly from the CMA’s own “specifications” for its epidemiologic study bid process, the proposal contained language that, while completely accurate, was subsequently considered to be a thoroughly indiscreet admission that the real purpose for the great confidentiality with which such studies were always conducted was not any concern for the privacy rights of the dead, or of their families, but was, in fact, based upon a desire to conduct their epidemiologic studies of former vinyl workers without letting them, or their families, know about it.
In particular, the reason for secrecy was to avoid potential lawsuits that might arise if employees were honestly notified of the purpose of the study, or even that a study was being conducted at all.
The indiscrete language read as follows: “If a particular case has been adjudicated, there is little reason to avoid family contact as this can be a valuable information source.”
Conclusions from the case control study were reported to CMA in a final technical report. No information was to be submitted by EHA for publication without consultation with CMA on the manner in which the data was to be reported.
3/3/80
By March 3, 1980, [81] disillusioned by Dr. Maltoni’s reluctance to conceal significant adverse health effects of vinyl chloride, the European companies that had previously sponsored Maltoni’s cancer studies issued a denunciation of Dr. Maltoni’s work that was circulated internationally.
The statement falsely stated that, in the early years, Maltoni’s work had led them to the discovery of angiosarcomas in workers highly exposed to VCM over a long period. Further, the statement fraudulently misrepresented that there was a limit to the amount of useful information which could be derived from the American vinyl industry conducting animal studies, and, in the case of VCM, the industry claimed to have had passed this limit some years previously, and that, henceforth, the only relevant and important studies would be those conducted on man (epidemiologic).
As a direct result of the enormous amount of work Maltoni had done for industry by the end of the 1970s, Dr. Maltoni’s laboratories were, for the lack of an Italian phrase, “blackballed” by Shell, Exxon, and an unknown but believed to be large number of American chemical companies.
Shell, Exxon, and the other American chemical companies admitted that, although the work produced by Maltoni’s laboratory was of high quality and credibility, drew upon a large historical database, and was even considered inexpensive. Despite this, Shell and the other companies openly revealed their intention to the other companies that they opposed any further use of Maltoni’s laboratories. Shell and the other companies admitted that the reason they wouldn’t sponsor anymore studies at Maltoni’s laboratories was, specifically, because Shell could not dictate the outcome Maltoni’s laboratories would report.
Shell specifically admitted that the MCA-coordinated vinyl manufacturers and their European partners had a problem with Maltoni because he had found vinyl chloride to be highly carcinogenic, reported it, and created a business problem for companies manufacturing vinyl chloride, even though they had sponsored his work.
3/4/80
On March 4, 1980, a Joint Meeting of the CMA Vinyl Panel and the VCRC met at Room 404 of the CMA Offices in Washington, DC. [82]. At this meeting the combined VCRC and Vinyl Panel openly discussed how they might best conceal the fact that they were conducting a brain cancer case control study from the subjects of that study, the families of their own former workers.
The CMA Group specifically discussed provisions in the CMA proposal (that CMA had written, then submitted to EHA with instructions that EHA redraft it and resubmit it to CMA) that had included a remarkable provision that indiscreetly acknowledged what every Panel member knew was the real reason the composition of the MCA / CMA cancer studies and why it was so important that the identify of the people in the TCA study be kept confidential:
At this meeting the Panel and the Research Coordinators decided to clean up the language of the CMA proposal so as to conceal the indiscreet reference to the group's true motivation for conducting their studies in secret - concern about lawsuits.
In place of the indiscreet reference to contacting family members only in "adjudicated cases," the new language proposed, discussed, voted on and adopted by both the VCRC and the Vinyl Panel provided that CMA's option, EHA might contact the deceased's family for additional details but that this would decided on a case-by-case basis and in consultation with the company involved.
The CMA Group also confirmed their commitment to perform a case control study of cancers in the central nervous system – another commitment that was deliberately broken for dishonest reasons (because the Group actively desired the study to misrepresent the true hazards posed by vinyl chloride and this no longer appeared to be possible, requiring the outright elimination of yet another funded and long discussed study the Group had committed to perform in order to prevent the studies they funded from actually detecting excess brain cancer in order to avoid finding out something that they did not want to find).
The rationale of avoiding finding something that the Group did not want to find (for economic reasons) was openly discussed and that very phrase was used.
The joint group of the Vinyl Panel and the VCRC made ad hoc modifications to the EEH contract and eliminated, on the spot, their previous commitment to study workers exposed in the years following the supposed adoption of more strict exposure limits in 1974.
The CMA-coordinated vinyl manufacturers, again, redefined and regrouped the study population into separate cohorts in a manner that assured the analysis of the data would be least likely to prove dangerous.
The CMA Group actually reprimanded the EHA for having the audacity to propose obtaining adequate job histories for the approximately 3,300 cohort members that had incomplete job histories as a result of the fact that plant management, and not the contractors hired to do the job, had been allowed to take over the data collection process and mollify quality control procedures with regard to a number of large plants.
The group decided to proceed with the study even after having been fully apprised that the study group included plants where living workers had been included but deceased workers had been excluded, plants where only active workers were included, but where no attempt was even made to even locate or ascertain the vital status of persons who were retired or terminated and not active.
The Panel continued to engage in their fraudulent "divide and conquer" method of categorizing vinyl plants, whereby the sponsors sought to obtain politically and economically desirable outcomes as a result of gerrymandering classes of exposed workers in such a way as to diminish the perceived hazard of vinyl chloride to those workers who the industry wanted the public to perceive as having insignificant, i.e., relatively low exposures.
3/14/80
On March 14, 1980, the Vinyl Panel[xix] voted to sponsor a thorough case-control evaluation and a clinical evaluation of each brain tumor. [83]
3/18/80 new paste
On March 18, 1980, an emergency meeting of the CMA Vinyl Panel was held at the Washington Hilton Hotel in Washington, D.C., concerning the TSCA 8(e) implications of the IBT audit.
General Counsel for the CMA, Ed Frost, addressed the Vinyl Panel at this emergency meeting and, in the course of the meeting, admitted each of those companies likely violated the TSCA 8(e) reporting obligations with regard to the results of the IBT audit, and formulated a plan to cover up their activities by submitting a "For Your Information" (FYI) submission to a low level official at EPA with the hope that this might mitigate the impact of any potential disclosure that the group had deliberately failed the mandates of TSCA8(e). They had decided to conduct a last minute, but incomplete, survey of the pathological specimens remaining after their purported "audit" of IBT in 1978.
The Group was aware of the presence of a patently excessive number of brain cancers in even the few IBT animals that had remained available at the time of the audit: That three of the six brains from rodents were available for analysis revealed brain cancer of a type not occurring spontaneously in that breed of animals, that this evidence would be interpreted as corroborative of the recently highly publicized to the sponsor's dismay at Texas City, Texas and would likely have placed extra unwanted attention on brain cancer at precisely the wrong time had it been reported, that their own minutes from the previous year were intentionally incomplete and did not reflect the recommendations they had received from Dr. Busey to examine other specimens of brain tissue that were available, that the head of NIOSH Field of Investigations, Dr. Joseph Wagner, was scheduled to present a paper at the forthcoming conference to reevaluate the toxicity of vinyl chloride, that he had been overheard on an airplane to state that he felt that he had at last obtained proper documentation of MCA/CMA misconduct that would "sink the CMA," and that there was a very real chance that "something was cooking" with the federal agencies that the sponsors were concerned might result in increased attention on their numerous acts of past misconduct, including deliberate acts and omissions with regard to the IBT studies, that they had been named in a conspiracy lawsuit entitled Waldrop v. Vistron, that, with almost incredible condescension the consensus of opinion in the Group was that to a "lay person" there might be a need to look at the remaining brains the Group had deliberately chosen not to examine, that the Group's misconduct had thus far remained hidden because all the conspirators had stuck together with none of them revealing in which the Group had been engaged for many years, but that the situation was likely to change since a lawyer inside Union Carbide had strongly recommended that at least Union Carbide file a TSCA 8(e) report on the brain cancers in the IBT animals, that if the lawyer were successful in persuading Carbide to conform with at least this one legal reporting obligation, the failure of the other members of the Group to have reported those same findings would likely become known, that the Group's 23 month interim report that had previously been submitted to the Government did not reveal the existence of the brain tumors at issue, that not even all remaining brain tissue had been salvaged from the study, that the account of the tissues found in the so-called audit did not include perhaps the most important available information about the state of the available pathological materials at IBT because an honest report would demonstrate the Group's own complicity and IBT's misconduct, that IBT was likely to be criminally charged and convicted for scientific fraud, and in the near future, including misconduct and studies conducted on a structurally similar chemical to vinyl chloride (TCE), that upon learning of the NIOSH scientist statement of intention to disclose information that might sink the CMA, the CMA legal department had intentionally set upon a course of obstructing justice and destroying relevant evidence in CMA's files that might be used against CMA in a criminal or civil proceeding to demonstrate their misconduct, that the lawyers had attempted to destroy all records in CMA's possession they could ascertain might likely sink the CMA if publicly disclosed, and that such an investigation was all but guaranteed should the unknown lawyer at Carbide actually prevail on Carbide management to finally file a TSCA 8(e) report even if it were years too late.
As part of this same scheme, the Group decided to go through the motions of seeking reimbursement from IBT (as if it were some innocent third party, as surprised by IBT's misconduct as anyone), when, in truth, the Panel had been complicit in nearly if not all of the significant acts of misconduct committed by IBT, and, as part of this cover-up activity, to authorize counsel for IBT to go through the motions of taking steps to terminate the IBT contract [six years after the Group had deliberately prevented IBT from completing the study or submitting the final report under the contract] and to thereby create a paper trail that would falsely appear to indicate an adversity of interests as between the soon to be criminally prosecuted IBT and MCA sponsors.
In fact, the Group had already decided that any action taken against IBT would be purely for the sake of appearances and to guard against the Group's potentially being caught up in the same criminal investigation that they knew would soon be forthcoming against IBT and at least one employee of a Vinyl Panel member (Monsanto), who, in a fashion almost identical to the manner in which Dr. Gaffey from Monsanto looked out for and protected his own interests as well as the interests of the Vinyl Panel in preventing the misconduct in which all those companies had engaged with regard to the TCA study from being disclosed, had been disguised as an IBT employee while watching over the IBT studies and protecting Monsanto's interest in obtaining a favorable outcome from the toxicological studies being conducted by IBT and to prevent the corrupt participation of Monsanto in those studies from ever being disclosed publicly.
The Group decided to submit the most recent January 9, 1979 report from Dr. Busey (EPL) to the EPA and to proceed immediately to conduct further pathologic analysis of brain tissues, known to be available as a result of the IBT audit – directly contrary to the decision this same Group had reached over the unprecedented strenuous objection of some Panel members like PPG's Dr. Zeb Bell as recently as the previous September, at which time, after due consideration of everything except their need to somehow try to head off their own criminal prosecution, the Group had specifically voted not retrospective auditing or expend further effort summarizing audit data, the previous September.
However, in view of the reassurances the Group received from their CMA lawyers that the CMA legal department had gone through all of the CMA’s files as part of an attempt to sanitize the files of documentation that might conceivably sink the CMA, and of reassurances received from Union Carbide’s Nick Wheeler that Carbide might not, in fact, file a TSCA 8(e) report that would risk exposing the misconduct of the whole Group, the emergency meeting concluded with a decision to do nothing more than file the previously described “CYA FYI Submission” to a lower level EPA information officer with the hope that the Group could at least point to this submission to (what was really little more than a dead letter office) EPA in lieu of complying with the obligations all the members of the Panel realized were their true reporting obligations under the TSCA Control Act.
The minutes of this meeting were themselves sanitized and do not reflect but a very small portion of all of the discussions, decisions and other activities that actually took place at this emergency meeting.
3/19/80
On March 19, 1980, Hasmukh C. Shah, Director Special Projects, CMA wrote to the Chief of the EPA Chemical Hazards Identification Branch, apologizing for not having previously sent him the Busey (EPL) report dated January 9, 1979.
The letter referred to 3 suspect brain tumors in male rats at the high dose level, as well as 1 at a lower dose level.
3/20-21/80
On March 20 and 21, 1980, NIOSH, OSHA, and NIEHS held a “Conference to Reevaluate the Toxicity of vinyl chloride, Poly vinyl chloride and Structural Analogues” in Washington, D.C.
The MCA-coordinated vinyl manufacturers’ representatives were in attendance at the March 20 and 21, 1980 federal government meetings.
Maltoni presented his recent work demonstrating that vinyl chloride was a multipotential carcinogen, which means that it produces tumors in many different organs and, in some cases, different types of tumors in a single organ. Maltoni reported that he had found a decrease in the incidence of tumors in animals receiving less than 10 ppm. However, this decline was not interpreted, as represented to the government, as evidence for a threshold level below which vinyl chloride did not present a hazard to animals.
In fact, exposure related tumors were present at every level tested.
In humans too, the consensus opinion was the carcinogenic effects of vinyl chloride exposure did not appear to be limited to the liver. Peter Infante, Director of the Carcinogen Identification Program at OSHA, summarized data from various human epidemiological studies on vinyl chloride. These studies showed wide variations in findings, but, when taken together, they indicated an even greater incidence of brain cancers than liver cancers among workers exposed to vinyl chloride. Lung cancers, too, occurred at more than twice the predicted incidence among vinyl chloride workers in four of the studies.
5/14/80
On May 14, 1980, the CMA Vinyl Panel[xx], VCRC and the MCA Audit Task Group met in the Jackson Room at the Washington Hilton Hotel in Washington, D.C.
After waiting years, the Panel had been able to obtain in less than two months an audit purported to include all brain tissues remaining from the flawed IBT research program.
The same emergency circumstances were also the subject of the joint meeting of the vinyl chloride Panel, VCRC and Audit Task Group in the Jackson room at the Washington Hilton hotel in Washington, D.C.
The Group received copies of EPL’s histopathology report on remaining brain tissues from mice, hamsters, and rats from what the CMA referred to as the “flawed” IBT research project, but which was actually more corrupt than flawed, since it was intended to be a corrupt study and succeeded very well at becoming one from the moment of its initiation in 1971 to its ignomius presence at this May 14, 1980 meeting.
The report from Dr. Busey indicates that as little as 3% and no more than 14% of the brains that were supposed to be available for any given exposure level as a result of the study actually were available at the time of the audit.
Dr. Busey’s report didn’t say (whether or not because the sponsors of the IBT study saw no reason to tell him about it) where the animals had gone off to, or why. The sponsors never revealed this to anyone else and there was no reason for them to reveal this to Dr. Busey unless for the unlikely circumstance that it would be obvious somehow from the written materials available at the time of the audit.
Under the circumstances involved at this time and at the time that this report was subsequently submitted to the information office at EPA, the EPL audit itself, and the CMA’s use of that audit, as it stood and as it was submitted to EPA deliberately did not contain information that an honest disclosure of the information that was actually contained in the audit report would have revealed.
The failure to disclose what the Panel knew about what had happened to the audited animals and why, while rendering an audit full of silent numbers in pages of meaningless charts, listing materials present and absent, yet not including any reference to the reasons, whys and wherefores about the IBT animals and their tissues, i.e., precisely the type of information that would have implicated the CMA Panel members and the conduct it now had decided to blame IBT for, forcing IBT to take the fall.
However, even in the CMA’s undeniably untimely submission of the results of the EPL audit, the CMA Group deliberately discounted the significance of their observation of the single cases of glioblastoma and astrocytoma in laboratory animals. There are statements on documents that glioblastoma does not even occur in animals and the occurrence of both glioblastoma and astrocytoma are certainly not spontaneous in this extremely small Group of vinyl chloride exposed animals it certainly was not some sort of spontaneous event, unrelated to their vinyl exposure.
The vinyl chloride Panel, VCRC and the IBT Audit Task Group received the audit report conducted by Dr. Bob West of Bob West and Associates.
5/14/80
The general council for the CMA, Mr. Edward Frost, had previously informed the Panel members who had recently informed the Panel of the CMA’s having attempted to sanitize their files of documents that might sink the CMA as inconsequence of having overheard on an airplane a conversation by a high-ranking government epidemiologist stating his opinion that there existed documentation that might sink the CMA.
At this meeting, he informed the Group of an acrylonitrile cancer case pending in Louisiana in which the allegation was made that the CMA had withheld important information concerning the carcinogenic properties of vinyl chloride in the early 1970’s. The case involved Union Carbide and two memoranda from R.N. Wheeler were involved – the memoranda he wrote documented the November 1971 meeting of PVC producers and the Ad Hoc Planning Group for vinyl chloride research, and his July 19, 1973 memo relating to the previously discussed fraudulent presentation MCA made to NIOSH on July 17.
The vinyl chloride Panel was thought to be the MCA/CMA entity that should bear the cost of the litigation alleging its conspiracy.
This takes on a different light when it is considered that the Vinyl Panels subsequent voluntary assumption of the cost of defending this and perhaps other conspiracy cases, and that no member of the Vinyl Panel had actually been named as a defendant in the Louisiana conspiracy case, the Panel by name was not even referred to in any of the plaintiffs’ allegations or discovery responses, the membership of the MCA Vinyl Panel was not revealed to the plaintiff in the Louisiana case, and, perhaps most importantly, that the Vinyl Panel members voluntarily undertook to pay the expenses for the defense of litigation in which, on the face of it, there weren’t involved whatsoever.
This indicates the companies recognized among themselves their responsibility for the activities alleged in the Waldrop petition (as opposed to the general membership of the CMA who would have otherwise borne the cost), and considered in their mutual interest to act in concert in secret in such litigation that involved two previously secret documents reflecting misconduct in which they have previously been engaged and act to prevent knowledge of their previous misconduct from spreading or disclosure of additional damaging documents and/or expansion of the case beyond a mere two documents and a couple of good stories into allegations that might prove damaging to all.
Ed Frost announced he would write letters to the lawyers representing the various companies on the vinyl chloride Panels in order to make financial arrangements for their support of the defense of CMA in the Louisiana conspiracy case in which none of them except Union Carbide and CMA were named as defendants.
At least as to this time, the vinyl industry had already begun its decades old method of operations: The companies actually defending the litigation did not need to be named as defendants and, as far as they were concerned, could remain completely unknown to have any connection to the litigation whatsoever; the discovery process would be neutered through the intervention of multiple layers of council, many of whom would be un-enrolled and with no direct accountability to any court with jurisdiction over the case, while, at the same time, allowed to direct the activities of lawyers at other layers, including local council, effectively serving as “the client” in the case, although, without any of the responsibilities or accountability.
The larger outside council firms would take deliberate efforts to prevent the local council, who would enroll and come before the court, from having knowledge sufficient to question the falsehoods, false issues, and fabrications. The outside council actually summarized briefs, prepared pleadings and correspondence to the local council who sometimes did little more than sign correspondence and pass on communications to the court received not from any “client” in the usual sense, but from a lawyer from one of these large law firms who coordinated the entire defense effort from the sidelines unseen by and unknown to either plaintiffs’ or the courts with jurisdiction over the case.
In the wake of certain specific losses in civil litigation, such as the landmark benzene case Skeen v. Monsanto, the CMA coordinated chemical companies, including members of the vinyl chloride Group such as Conoco, Inc., Shell Chemical, and Union Carbide met and prepared a comprehensive industry-wide litigation strategy, the centerpiece of which was the concealment of evidence that at any cost.
It was the policy of the strategy adopted in benzene and vinyl chloride cases that relevant documents would not be voluntarily produced, that cases that the industry hoped they might win on the medical issues should be paid rather than having to reveal sensitive documents, and that sensitive documents should be released only as a last resort when everything else failed, and only upon a direct court order.
In attendance at these meetings was Dr. Otto Wong, in his capacity as a testifying epidemiologist in the Skeen case and by virtue of his experience conducting epidemiological studies for the petroleum and chemical industry.
Dr. Wong was present and could only have heard the comprehensive and coordinated industry response the companies that had paid him to come to the meeting were planning (overhead projections with statements like produced sensitive documents only on court order) were projected onto large screens with overhead projectors. The presence of such experts was no coincidence.
At this time, still reeling from setbacks and asbestos and other “toxic tort” litigation of recent years, as well as from the promulgation of vinyl chloride and benzene regulations, the American Chemical Industry, including but not limited to the petroleum industry, implemented policies that were intentionally designed to make the positions that the member companies took in regulatory proceedings, in court, and in science as mutually consistent as possible.
It was standard procedure for trade associations such as the benzene task force to consider the extent to which scientific studies would be considered not only on their own merits – like preventing disease – but also as part as the industry’s overall strategy in defending tort litigation and defeating environmental and occupational health legislation.
The committee, again, committed to evaluate the underlying database and then proceed with the five-year update of the cohort they had assembled in the mid-1970’s and had received at least nine reports that were suppressed and never allowed to be published or otherwise made known to the general public.
5/14/80
At the CMA Vinyl Chloride Project Panel Research Coordinators and Audit Task Group meeting, held May 14, 1980, copies of Dr. William Busey's histopathology report on all remaining brain tissues from mice, hamsters, and rats exposed to vinyl chloride in the flawed Industrial Bio-Test (IBT) research project were distributed to those present. Dr. Busey made an oral presentation of his findings to the Group.
Histopathological examination of the rat brains revealed olfactory neuroblastomas in seven animals (five males and two females) exposed to vinyl chloride at the highest dose level. This type of tumor was the same as that diagnosed by Maltoni as a “neuroblastoma” and was characterized histologically by pseudo-rosette formation and a high incidence of mitotic figures. In addition, a single glioblastoma multiforme was detected in one male rat exposed at 200 ppm, and a single astrocytoma was found in the brain of a female rat exposed to the same concentration.
Dr. Busey concluded that a causal relationship existed between vinyl chloride exposure and the development of olfactory neuroblastomas, as these tumors rarely occurred spontaneously in the rat. No significance was attached to the single occurrences of the other tumor types found.
5/15/80
At the May 14, 1980 CMA Vinyl Chloride Project Panel, Research Coordinators and Audit Task Group meeting a motion was made to accept Dr. West's report with the words “Confidential and Privileged” removed from each page. The motion passed unanimously.
The attendees agreed to send all reports to Kover and other Federal agencies.
5/14/80
At the time of the May 14, 1980 meeting, the Panel agreed that they would travel to California to meet with EHA to negotiate the conduct yet another series of epidemiological studies, the results of none of which would ever be published until at least 1991, and even then the sponsors would claim that the publication constituted a breach of contract.
The CMA Group prepared for a upcoming ruklemaking on vinyl chloride exposure and/or dust exposure. The Group specifically referred to the request for information that OSHA had published in response to federal agencies.
Except for two Louisville annual reports submitted to the OSHA response to a previous FYI request in December 1979, the CMA had submitted one report from TCA to OSHA on one report dated May 4, 1974 at the time of the hearings on the OSHA’s proposed permanent standard, and had offered the at least ninth “final report” it received from EEH between 1976 and February 1978, none of the at least eight final reports the Group had received from TCA and EEH over the years, none of the information from the University of Michigan, say nothing of the drafts, modifications that didn’t require an entirely new report, etc., and to say nothing of the many important unpublished reports the MCA and CMA Groups had held secret from their own workers and their own government as long before as 1970 and as recent as the suppression as the IOM Dust Study in 1979.
Notwithstanding the foregoing, the CMA Group made the concerted decision to submit nothing to OSHA in response to its request for information apart from the two reports other than the reports it had already submitted to them in years past. Every member of the Group intended that, on their behalf, the MCA would submit only reports previously disclosed to the government after the Vinyl Panel had approved them, but to a company that in complete submission with any of the information they had been holding secret for beginning at least in 1966.
5/28/80
The Vinyl Panel received a report from the IBT Audit Task Group (ATG) that it had detected a wide variety of brain cancers in rats.
Although no more than a small percentage (3-14%) of the brains for animals exposed at any given dose level were present, histopathological examination of the brains revealed olfactory neuroblastomas in seven animals exposed to vinyl chloride at the highest dose level.
This type of tumor was reported to be the same as that diagnosed by Maltoni as a “neuroblastoma.” In addition, a single glioblastoma multiform was detected in one male rat exposed to 200 ppm of vinyl chloride, and a single astrocytoma was found in the brain of a female rat exposed to the same concentration.
6/26/80
On June 26, 1980, the SPI, PVC Safety Group Summary of Conference to Reevaluate the Toxicity of Vinyl Chloride, Polyvinyl Chloride and Structural Analogues was presented at a conference.
The conference was a review of the real or alleged health hazards from vinyl chloride and polyvinyl chloride, in relation to the workplace and the community. There was little new information. Both industry and government have been long familiar with the important animal and epidemiological studies on vinyl chloride, which formed the basis of this symposium.
Some issues as possible future concern to the industry did arise: The alleged relationship between vinyl chloride monomer and brain cancer: the possible new evidence, and new reorganizations of older evidence might be interpreted to give added strength to the argument for a link between VCM and brain cancer.
There was a great deal of evidence presented to demonstrate that PVC dust did indeed cause pneumoconiosis, and perhaps a number of other pulmonary diseases. From the volume of material presented, it would appear that OSHA has become very interested in PVC dust as a workplace hazard.
Of particular interest to industry were two papers presented on the use of power, which is a quantification of a studies sensitivity or ability to detect an increase in risk.
Negative studies, which have a high power and are able to detect a small increase or decrease in an effect, would, therefore, carry greater weight. It was recognized by the CMA Group that strategic use of power could enhance American vinyl industry’s ability to gain acceptance of test results where effects have not been seen and may provide and may provide a factual weapon fir demonstrating non-validity in studies of poor design.
The symposium thoroughly reviewed the carcinogenicity of vinyl chloride monomer, and attempts were made to link VCM with brain and lung cancer, as well as hepatic angiosarcoma, in both animal and epidemiological studies (see discussion below.)
Several papers attempted to show a relationship between vinyl chloride and birth defects or other reproductive problems.
In the sessions dealing with polyvinyl chloride, the primary emphasis was on the relationship between PVC dust and pneumoconiosis. Participants reported on the results of animal testing with PVC dust in addition to epidemiological and case studies of PVC workers. There was also a dubious report on PVC as a carcinogen, by Dr. Chris Wagner of Wales. An epidemiological study by Richard Waxweiler of NIOSH suggested a link between PVC dust and lung cancer.
The conference also dealt briefly with effects of vinyl chloride and polyvinyl chloride in communities where plants are located. Industry was given a clean record on environmental exposure except in the area of alleged teratogenic effects. Reviews of literature by Downs et al. and MacMahon have clearly established the numerous flaws in these studies. However, neither these reviews nor the deficiencies were mentioned.
The final sessions of the conference discussed, rather inclusively, the carcinogenicity of structural analogues of vinyl chloride and attempted to discuss the role of public health agencies in dealing with toxic substances.
Observations made at the conference: (1) On brain cancer: Dr. Maltoni’s testing suggested a causal relationship between VCM exposure and cancers of the brain, although Maltoni was not able to show a dose-response relationship. However, epidemiological studies, in particular the industry-sponsored EEH study, also showed a somewhat high incidence of brain cancer in workers with heavy VCM exposure; These findings were confirmed by tests of the power of epidemiological studies by Dr. Jay Beaumont of NIOSH: studies with positive results had a higher power than negative studies (i.e., had a statistically better chance of being accurate), and when plotted, showed the expected trend for a carcinogenic response; The results suggest the need for further studies on VCM as a possible brain carcinogen; (2) On VCM and breast cancer: As reported in an earlier summary, Maltoni has produced breast tumors in mice in exposures as low as ten ppm. At this time, there is no other data to support these results; (3) On VCM, PVC, and lung cancer: A study by Dr. Y. Suzuki of Mt. Sinai Medical School, attempted to link VCM exposure with tumors of the lung in twenty-six mice (out of 27 exposed.) The study has not been reproduced, and is not supported by most epidemiological data. Furthermore, tests of power for lung cancer results showed a lower power for studies with positive results and a higher power for those that were negative. So there is no valid statistical increase in risk of lung cancer for VCM workers at this time. Similarly, Dr. Richard Waxweiler’s case-control study of lung cancer among vinyl chloride and PVC workers, purportedly showing an increased risk for workers exposed to PVC dust, cannot at this time be considered significant; (4) Reproductive Effects of Vinyl Chloride: Results of studies by Dr. Jackie John of Dow Chemical showed that exposure to vinyl chloride in doses high enough to cause maternal toxicity did not produce teratogenic effects in the mice, rats, or rabbits tested. Dr. Jill Fabricant of the University of Texas sought to show teratogenicity by proving mutagenicity (a dubious linkage). Tests of power, by Maureen Hatch of Columbia, showed that most studies with negative results were of greater validity than tests that showed a greater increases risk of reproductive anomaly. There was little hard data suggesting vinyl chloride was a teratogen. However, it was recognized that there was fuel for controversy in this issue, and its attractiveness for the media cannot be discounted; (5) PVC Dust and Pneumoconiosis: Results of animal testing and epidemiological studies presented by several participants in the conference strongly suggested that there is a link between PVC dust and pneumoconiosis. Conference reports indicated that PVC dust is respirable and that it lodges in the lung and can decrease breathing capacity. The study sponsored by ICI showed that the group of workers who smoked and were exposed to heavy concentrations of PVC dust showed a significant decrease in breathing capacity. A perceptible, but not significant, decrease occurred in workers who didn’t smoke.
8/15/80
As previously shown, the chief research chemist for Conoco Chemicals had been chosen by the IH & Monitoring Sub-Committee of the MCA Vinyl Panel to advise the companies on the Panel as to the suitability of charcoal-based personnel monitoring methods for vinyl chloride.
As early as 1974, the IH & Monitoring Sub-Committee had learned that, in the opinion of the scientists they had hired to investigate the matter, it was utterly inconceivable that anyone would monitor vinyl chloride using charcoal-monitoring methods.
As a result, by August 15, 1980, when it began evaluating 3-M Organic Vapor Monitor (OVM) dosimeters for monitoring vinyl chloride, if anyone knew how unsuitable charcoal-based monitoring methods were, it was Conoco Chemicals. (As previously stated, however, every MCA-coordinated vinyl manufacturer is chargeable with constructive knowledge of the misleading nature of charcoal-based monitoring methods because the OSHA standard required them to validate whatever type of monitoring method they chose to employ.)
Any company, who ever tried to validate charcoal for monitoring vinyl chloride (as they were required by law to do), was bound to have independently “re-discovered” the incredibly misleading results that the Industrial Hygiene and Monitoring Sub-Committee had discovered in 1974, if, by some chance, they had happened to miss it the first time around.
If these companies actually attempted to validate charcoal monitoring methods (as they were required by law to do), they can only have confirmed that the retentivity for VCM was very poor, that VCM was readily desorbed from the charcoal collection medium by both dry and humidified nitrogen indicating that VCM was weakly adsorbed. As a result, if exposure levels early in the day were greater than those in the afternoon, a worker’s cumulative exposure as indicated by a charcoal-based personal monitoring method would, paradoxically, decrease, and not increase, as the day went by.
Any honest validation of charcoal-based monitoring methods would show that vinyl chloride was held very weakly to charcoal, and that the collection efficiency of charcoal was less than 100%, resulting in a maximum detectable level for VCM was not even constant, but, instead, dependent on the concentration of VCM and the environmental conditions present during and after the charcoal-based monitoring device was exposed to workplace concentrations of vinyl chloride.
Although passive monitors with charcoal tube and pump were equivalent methods of monitoring VCM, the bad news was that neither the charcoal tube, nor the passive monitor, provided an accurate value for personnel exposure to vinyl chloride.
Upon information and belief, every MCA-coordinated vinyl manufacturer on the Vinyl Panel in 1974 knew what misleading results would follow if charcoal were used to estimate employee workplace exposures. Any vinyl manufacturer attempting to comply with the law after 1974 by conducting validation studies for this type of monitoring, knew that the use of this method would grossly underestimate exposures and give the appearance that the monitored worker was exposed to far lower levels of vinyl chloride than the reported results would indicate. Workers exposed to many times the Permissible Exposure Limits (PELs) for vinyl chloride would appear to be sustaining exposures no higher than the action level for vinyl chloride.
As a result of the use of charcoal-based monitoring methods, entire workplaces in the vinyl industry could, and would, be “deregulated,” as the neologism went, and treated as if virtually no hazard from vinyl chloride was expected in such areas, even when, in fact, exposures in such areas might actually have exceeded, as believed to be precisely the case, on a regular basis the PEL for vinyl chloride established by law.
The charcoal-based monitoring methods, simply, would not reveal the violation of the OSHA standard for vinyl chloride.
9/17/80
As all of the companies represented on the Vinyl Panel knew, the purpose for conducting any update (whether 5 years, 7 years, 9 years, or 10) was, at least in part, in order to possibly weaken any association between vinyl chloride exposure and brain cancer, lung cancer, or leukemia that had previously been demonstrated (or any other cancer besides the extremely rare cancer, angiosarcoma).
The study population that was the subject of the 1986 EHA report was not at all the same population that EEH had analyzed in 1978.
Despite what the MCA-coordinated vinyl manufacturers would deliberately allow or cause many epidemiologists and occupational health professionals to mistakenly believe, a significant number of plants had gone missing in the years before any update was published. For example, the large PVC plant owned by Firestone in Pottstown, PA, was out of the study by the 1980s, just as it had been excluded from the original TCA studies published in 1974.
The Panel learned that, at this late date, at least ten angiosarcoma cases had been diagnosed at the PVC plant operated by Gulf in Shawinigen, Quebec.
9/17/80
On September 17, 1980, the VCRC met at the Offices of Dow Chemical USA in Washington, D.C.
The Group reviewed the EHA July 1980 proposal to update the old TCA / EEH cohort that was misreported to have consisted of 37 individual plants operated by 17 companies.
Since the proposal was supposed to be a five-year update (it was necessary to say supposed to be) and since neither this five-year update, nor the subsequent seven-year update, nor the subsequent nine-year update, would ever see light of day, and the 1986 ten-year report would not be published until 1991, eleven years later, and even then, this publication would result in claims that the publication had been in breach of contract. The sponsors made a big point of requiring TCA / EEH to update their employee work histories to cover the period of 1972-79.
However, the Group appreciation was that this would not effectively bias the results in the manner that they had hoped, of course, therefore, there was no reason to do it and it wasn’t done.
A specific goal of this five-year study – the CMA Group would never allow to be performed – was to determine whether the cancers that were still in excess at the time the original TCA database was “augmented” in the final EHA / EEH report in 1978. (Brain cancer, lung cancer, and leukemia.)
Although the Group had paid EHA to evaluate the underlying database and had received a report that was absolutely devastating in terms of its assessment of its integrity of the underlying database (or lack thereof), the Vinyl Panel had basically shouted down EHA’s conclusion at the end of its assessment of the underlying data that it might be a good idea to correct at least some of the more egregious of the three thousand plus deficient records that they themselves had characterized as deficient and not useable.
Instead, the Panel insisted that EHA go ahead and analyze the data anyway, as if it were thought to be reliable or valid data and in direct contradiction to the plainly stated findings EHA had made in the course of its assessment of the underlying database. EHA was told to take the study or leave it and was specifically denied the opportunity to even to attempt to correct the deficiencies that EHA had gone to the trouble and expense of characterizing in some detail.
The fix was in: EHA recommendations or any consideration with regard to the integrity of the underlying data were completely disregarded, shouted down, and EHA was given the simple option of analyzing the defective data “as is,” or not analyzing it at all.
EHA didn’t want to play ball with the Panel, so the Panel threatened to chop the data EHA had laundered for them (although without correcting even the obvious deficiencies that they cold reviewed of the EHA records had revealed to the EHA.)
The participating companies agreed to prorate their cost-sharing of the new contract with EHA based upon their PVC/VCM production capacities for 1979.
The VCRC discussed their pending plan to bring the trumped up “dispute” with IBT to a conclusion through a monetary settlement that would preclude the further airing any of the dirty laundry shared by IBT and the CMA Group, and of which the CMA Group had expressed its painful awareness over the course of the last six years while the Group pretended to be waiting in honest expectation for a final report from IBT.
The Group planned to solicit wider participation for the project within the vinyl industry as it existed as of 1980.
9/26/80
On September 26, 1980, the VCM Research Coordinators Task Group met at the Dow Chemical offices at Washington, D.C. on Sept 17, 1980, to discuss the Environmental Health Associate’s (EHA’s) proposal to update the Tabershaw-Cooper / EEH VCM/PVC (TCA’s) study.
The VCRC recognized that the main interest in doing this seven-year follow-up was to concentrate the effort on the whereabouts of the original (1972) cohort and for those that died to determine their cause of death.
The VCRC also recognized an obligation to conduct the brain cancer case-control study they had been claiming an intention to perform for several years, admitting that the higher than normal brain tumors in the original study had never been followed up as had been suggested.
Further, the link of vinyl chloride with lung cancer and cancer of the lymphatic system (leukemia) by governmental agencies was still unresolved.
The VCRC recognized at the outset that the proposed research at EHA would not shed any further data on angiosarcomas; The sponsors’ motivation for conducting the study from the outset (and the way the update was “sold” to the management of the participating companies) was the hope that the updated study might not support the animal data and previous epidemiologic studies.
The previous studies had created an overwhelming consensus in the independent scientific community that vinyl chloride caused a wide variety of other types of cancer besides the extremely rare angiosarcoma of the liver, as illustrated by the then most recent report of the International Agency for Research on Cancer (IARC, an agency of the World Health Organization (or WHO) of the United Nations [UN]).
The company representatives openly discussed the value a study that would support their ridiculous and self-serving “angiosarcoma only” stance could have in personal injury litigation – they, already, openly anticipated with some dread.
Members openly stated their belief that the updated study would be worthwhile even if its only value was in creating scientific information the sponsors could use in the CMA-coordinated vinyl manufacturers’ defense of future personal injury lawsuits.
At the VCRC meeting, the companies discussed with Ed Frost, general counsel for CMA, what to do about IBT. Because the sponsors were aware that their own misconduct might be brought to light in a serious lawsuit against IBT, the companies discussed the many reasons why they should attempt to resolve their differences with IBT out of court.
11/14/80
By November 14, 1980, If the CMA Group had truly wanted to clarify any question they thought still existed about the relationship between exposure to vinyl chloride exposure and the development of brain tumors nothing was stopping them from doing so; after all, the Group had agreed to conduct the study long before.
However, the CMA-coordinated vinyl manufacturers had been specifically advised that conducting such a study would do more to clarify the association between brain tumors and vinyl chloride than even the proposed cohort update. Notwithstanding this, (and probably because of this), the CMA-coordinated vinyl manufacturers went ahead and aborted the brain cancer study, even though the Panel[xxi] had already approved it on multiple occasions, funded it, etc.
Dr. Don Whorton, who was a senior epidemiologist at EHA and one of the principal authors of the proposed EHA studies (Dr. Whorton was one of Dr. Wong’s partners at EHA) warned the CMA-coordinated vinyl manufacturers that the companies would have to be prepared to accept a bad result.
Dr. Whorton appears to have been somewhat candid with the CMA study sponsors: If the CMA went any further with the study, they should be prepared to for the study to find something they certainly did not want the study to find (referring to brain cancer, of course).
Prior to a highly unusual meeting with his CMA sponsors at Dr. Whorton’s offices in Berkley, California, Dr. Whorton had made a preliminary analysis of the data for the brain cancer study. In the course of this meeting and after reviewing the evidence, but before the “formal” study had begun or any written report could issue, Dr. Whorton (the would-have-been author of the doomed brain cancer study) shared his “preliminary” opinions, and predicted a result that the sponsors did not want to hear.
At the time of the Vinyl Panel’s meeting with Dr. Whorton at EHA’s offices in Berkley, Dr. Whorton, was reported to have warned the Group that, based on the brain cancer study data he had examined in preparation for the meeting, a study of the 12 TCA and EEH brain cancer cases would very likely only prove what the Group already knew, there would be more brain tumors in the vinyl chloride exposed Group.
No legitimate reason existed for the industry representatives to – just out of the blue – abort the EHA case control study of the 12 brain cancer cases they had identified in the course of the studies they had conducted since 1973. However, without a legitimate reason (or, perhaps even more remarkable, without even bothering to fabricate a legitimate sounding reason as a pretext), at the last minute, the vinyl industry representatives just killed the brain cancer study at EHA without even the trouble of a “for the record” pretext.
However, the need for the CMA-coordinated vinyl manufacturers to, at all cost, avoid conducting a scientific study that was against their financial interest was apparently more important than the truth, and clarifying the association between brain tumors and vinyl chloride exposure became an unlikely proposition for the American vinyl industry.
Dr. Whorton’s oral report to the vinyl industry representatives had been made “off the record” of course, so no record of the actual analysis was made (as opposed to the results of that “informal” analysis, which were duly recorded). However, Dr. Whorton had clearly examined the data on the 12 brain cancer cases and, at the time of the Panel’s meeting with EHA in Berkley, predicted for his sponsors the results they might expect to receive if he went ahead and conducted the formal study (and report).
However, despite having recognized the need to conduct the brain cancer case control study for years prior to beginning it, the CMA-coordinated vinyl manufacturers quickly abandoning it in 1980 – and as a direct result of the informal and off the record report the CMA-coordinated vinyl manufacturers had received from Dr. Whorton at their special meeting in California
The stated rationale for abandoning the case control studies was, for once, candidly stated and not a pretext: If the CMA-coordinated vinyl manufacturers allowed the study to go any further, the sponsors might not been able to avoid providing science with even further confirmation of the association between brain cancer and exposure to vinyl chloride that had long since been demonstrated by previous studies.
The studies were aborted without so much as a pretext for a reason: They not only stood no chance of calling the near universally recognized relationship between exposure to vinyl chloride and brain cancer into question and would probably only provide more confirmation of what the sponsors admitted (privately) they already knew, i.e., brain cancer would be found to occur more often in the vinyl chloride exposed cases than in the control Group.
The sponsors openly admitted and discussed (again, of course, only among themselves) that the most they could realistically hope for, if they allowed the study to continue, was finding something they did not want find (i.e., yet more proof that vinyl chloride caused brain cancer), the EHA brain cancer study had to go. The ongoing study was promptly aborted.
In the closest thing to a pretext the CMA Group employed in the course of killing the case control brain cancer study, the Group put on the record a reference to perhaps reconsidering whether to conduct the case control study after the overall 5-year (then) update was completed.
The CMA-coordinated vinyl manufacturers referred to whether to risk of conducting the case control study they had just indefinitely postponed as a "hard decision” that the Group would have to make sooner or later.
So the CMA-coordinated vinyl manufacturers decided to put off making this “hard decision” until later, i.e. in 5 years, i.e., never, since, in fact, neither a five-year update or the case control study was never performed.
In any event, although the data that could have been used for a such a study was collected, after considering it on November 14, 1980, the CMA Group made their "hard decision.”
The CMA-coordinated vinyl manufacturers decided to do neither the brain cancer case control study nor the five-year update.
As will be shown, it would take another 15 years, until 1995, before the CMA-coordinated vinyl manufacturers were sufficiently reassured (by Dr. Tamburro at the UOL) that a brain cancer case control study could, after all, be designed with absolute assurance (written even) that no outcome that the sponsors had not fully approved was even possible. Only then would the CMA-coordinated vinyl manufacturers conduct any type of brain cancer case control study, finding the “hard decision” suddenly much easier.
(And, as will be shown, Dr. Tamburro’s was no ordinary study, by any criteria. Not only did Tamburro openly predict a favorable result for the sponsors at the time he proposed it to them, the study employed extremely unorthodox, if not bizarre, so-called “parametric exposure assessments,” of Tamburro’s own devise)
11/14/80
On November 14, 1980, the Vinyl Chloride Industry Representative (Vinyl Panel) met at the Sheraton Airport Hotel Pittsburgh, PA.
Although denominated the CMA “vinyl chloride industry representatives,” like previous name changes from the Technical Task Group for vinyl chloride research, to the vinyl chloride technical Panel, to the vinyl chloride program Panel or vinyl chloride project Panel.
The names had changed but the parties in attendance were precisely the same. The goal of this Group was to conduct the brain cancer study they would never allow to be performed and to conduct the five-year update of the American vinyl industry cohort they would have never allowed to be published either because the Vinyl Panel had already abandoned its effort to conduct a five-year update (demonstrating one of the advantages of never publicly announcing specifics about planned ongoing scientific research programs.)
Apparently having learned a lesson from all the unnecessary fabrications and fraud they have had to go through in order to scuttle their publicly low-dose and single-dose exposure studies when, in the mid-1970’s, they had realized they weren’t going to get anywhere calling the rest of the world’s literature on the toxicology of vinyl chloride into question with their IBT studies.
In the course of reviewing the July 1980 EHA proposal to go through the motions in some manner attempting to update the same database EHA had just the previous summer determined to be unsalvageable without major corrections, the CMA informed all the representatives present, or who had received the minutes of this meeting that didn’t already know, if there were any, that the so-called industry study they planned to fraudulently update had originally been comprised of thirty past and present VCM/PVC manufacturers of whom only seventeen showed any interest in continuing, seven unable to attend, five not heard from, and one outright declining participation.
The Panel discussed among themselves that the observed increase in the number of brain cancers as compared to that expected was striking, but that, with this single exception, the biases deliberately introduced by the sponsors into data collection process and the analytic methods had achieved at least the desirable result of keeping most types of excess cancers at a level below statistical significance, as the sponsors recognized, at least gave the Group plausible deniability.
The Group maintained hope that, with the help of their continued concerted bad faith efforts, they might be able to somehow shave enough points off SMR for brain cancer to reduce below the almighty statistical significance that the Group would illogical insist had to be present in every study they put any stock in (and no matter what they had done to the study to specifically avoid statistical significance).
The irresponsible and overreaching conclusions that Dr. Torkelson had flown into the backdated January 1978 report had become a goal of the committee.
The quest for the study, the paper, the analysis, that would allow the American vinyl industry to pass the whole issue of vinyl multi-potential carcinogenicity aside leaving the extremely rare liver cancer angiosarcoma as the only form of cancer scientifically attributed to vinyl chloride exposure became a sort of holy grail for the vinyl industry over the next twenty years, and would lead to an even greater reluctance to correct the flaws in the underlying database as well as truly shameful attempts to obtain pathological specimens from the bodies of workers they had previously employed-without the use of medical authorization forms and specific precautions to prevent family members from learning of the study-for no better purpose than an unfounded optimism that a closer examination of cancers every previous epidemiologist had classified as liver cancer for biliary to track cancer was, in fact, primary liver cancers at all, but simply misdiagnosed cases angiosarcoma.
It led to the search for persons of such renown and general credibility that the absurdity the vinyl industry wanted to manufacturer as a sort of consensus position-at least among the scientists whose work was sponsored by the vinyl industry or who naively held such studies in regard or even put any stock in whatsoever.
11/14/80
As previously shown, a frankly articulated guiding principle that had governed the design and conduct of MCA and CMA-coordinated cancer studies since at least early 1973 was for those studies to “defocus” cancer.
One way, as the sponsors had discussed years before the 11/14/80 VCRC meeting was to include information was irrelevant to any serious legitimate concern, but, nevertheless, useful for obfuscation and the conduct of misleading statistical analyses. This was a goal the MCA coordinated vinyl manufacturers had discussed in just those explicit terms at least as early as 1973.
At the 11/14/80 meeting, the CMA-coordinated vinyl manufacturers discussed a way of defocusing the cancer aspect of the study of vinyl chloride workers; throwing estimates of EDC exposure levels into the analysis, and then analyzing the data in terms of all but meaningless distinctions between various PVC manufacturing processes
11/14/80
The Group was informed that they would shortly be receiving their prorated share of a $110,000.00 settlement the CMA lawyers had negotiated with the lawyers for IBT.
The Panel openly recognized that there were many other good reasons not worth putting on the record for them to proceed with their so-called dispute with IBT in as low key a manner as possible. Even in 1980, the CMA coordinated Group’s so-called settlement with IBT did not appear to have been much more than superficially adversarial.
11/14/80
On November 14, 1980, a meeting of MCA-coordinated vinyl manufacturers referred to as the “Vinyl Chloride Industry Representatives” (VCR), met at the Sheraton Hotel, in Pittsburgh, PA.
The specific purpose for the meeting was to discuss what had previously been a five-year EHA update, but was now referred to as a seven-year update (and which, as will be shown, would never be conducted either).
The November 14, 1980 VCR meeting, was most especially concerned with the brain cancer issue, an issue that had come into very sharp focus as a result of the Texas City incident. The VCR was advised that conducting the brain cancer case-control study would do more to clarify the association between brain tumors and VINYL CHLORIDE exposure than anything else the group might do, including the conduct of the proposed seven-year update.
The benefit of updating the first study, versus conducting a case control study, was discussed. However, because the group realized, and openly discussed, the fact that conducting a legitimate case control study of the brain cancer cases identified in the previous studies would only create additional evidence that the brain cancer cases were related to VINYL CHLORIDE exposure, the CMA-coordinated vinyl manufacturers decided to postpone the case control study, supposedly until additional brain tumor deaths were identified in the course of the, now, seven-year update.
The VCR unanimously recommended that employee work histories should be updated to cover the period between the end of 1972 and the end of 1979. The CMA-coordinated vinyl manufacturers wanted to document the so-called lower exposures that existed after 1974 as part of their effort to downplay the significance of post-1974 exposures.
The question of accuracy of group exclusion or inclusion in the previously conducted studies was considered. For example, it was well known to the Vinyl Panel that a large number of heavily exposed workers from entire plants had not been allowed to participate in previous studies, and that even large groups of heavily exposed workers from plants that had participated in the previous studies had, nevertheless, been excluded throughout the time the previous studies had been conducted. Similarly, an unknown, but certainly large, population of workers with little or no vinyl exposure who had been improperly identified by their employers as VINYL CHLORIDE exposed and had, therefore, been improperly included in all previous studies.
Notwithstanding the CMA-coordinated vinyl manufacturers specific knowledge that extremely large numbers of workers with no, or very little, exposure had been included and many workers with the heaviest exposures had been excluded from all of the previous studies, after specific discussion, the VCR agreed to leave the original cohort exactly as it was, and that no attempt would be made to correct any such deficiencies. (Except for inconsistencies in the database that external reviewers might notice, such as incorrect birth dates, social security numbers, etc.).
Even though all previous contractors had recognized the misleading nature of the estimates of worker exposure levels that had been used in the original studies, and although EHA strongly believed it was necessary to eliminate their use in any future study, the CMA-coordinated vinyl manufacturers directed EHA to use the old, misleading exposure levels anyway.
Instead, at Dr. Gaffey’s suggestion, the CMA-coordinated vinyl manufacturers required EHA to analyze the data both ways (i.e., no exposure classification would be assigned to the work histories generated post-1972, but job exposure classifications generated prior to that time would be retained).