1/28/75
Dr. Monson published an article in Lancet.
The study showed an -- 50% excess of deaths due to all cancers was found with the greatest excess in cancers of the liver, biliary tract, lung and brain.
The SPI VCM / PVC Producers Group discussed the fact that the NIOSH study had found a 57% excess in cancer deaths above expected.
At some time prior to the 1/28/75 meeting, an SPI representative had solicited a proposal for research from the University of North Carolina. In the course of making this proposal, the researcher reviewed 5 U.S. mortality studies of vinyl workers and discussed their importance; 1) most tumors manifested themselves 11-20 years after exposure to vinyl chloride; 2) the excess deaths demonstrated by the studies were not just due to angiosarcoma, but included cancers of the respiratory and the hematopoietic systems and brain; 3) some angiosarcomas had occurred from low-level vinyl chloride exposures, even non occupational vinyl chloride exposures.
The SPI VCM / PVC Producers Committee were advised of the possibility of excess lung cancers, lymphomas and brain cancers were associated even with low-level occupational, and that even the possibility that non-occupational exposures might cause these cancers had to be seriously considered.
1/31/75
On January 31, 1975, the U.S. Court of Appeals for the 2nd Circuit denied the appeal of the MCA-coordinated vinyl manufacturers (SPI, Hooker, Union Carbide, B.F. Goodrich, Firestone, Uniroyal, General Dynamic, Diamond Shamrock v. OSHA) to delay and rescind the OSHA’s regulations.
The Court of Appeals, Mr. Justice Clark, U.S. Supreme Court, retired, held that evidence supported adoption of an exposure level of not in excess of 1 part per million averaged over any 8-hour period.
The Court held that the vinyl chloride standard was not technologically or economically infeasible, and further, that those who fabricated products out of vinyl chloride were properly subject to the OSHA regulations, and that the Secretary of Labor did not exceed his power in adopting the “cancer suspect agent” labeling requirement. Mr. Justice Clark held that it was already clear the workers in all components of the vinyl chloride industry were being subjected to a serious health risk of harm as a result of their VCM exposure.
The Court held that although conclusive proof of the carcinogenic character of VCM did not emerge until after the discovery of angiosarcoma at BFG Louisville, strong warning signals had appeared long before, and that as early as 1949, when the vinyl chloride industry had barely reached its tenth anniversary, a study conducted among vinyl chloride workers in the Soviet Union found liver damage in 15 of 45 workers studies, and in 1958 and 1959, Dow Chemical scientists had elicited liver irregularities in rats and rabbits at a 100 ppm concentration of VCM.
Justice Clark believed that Dow had, in some more than technically accurate sense, recommended a 50 ppm allowable level in 1961, but that the industry adhered to its previous 500 ppm standard. The Court reviewed what it called the MCA’s “morbid ‘vinyl chloride Chronology,’” that, as previously shown, was represented to provide a full and complete history of the development of knowledge within the Vinyl industry as to the hazards of vinyl chloride exposure. Justice Clark held that the MCA’s own chronology showed what could only be described as a course of continued procrastination on the part of the industry to protect the lives of its employees.
2/13/75
On February 13, 1975, the VCRC met at the MCA Conference Room in Washington, D.C.
Dr. Torkelson, the Chairman of the VCRC, reported that the committee still had said nothing they thought suitable to use as a pretext to justify the group’s abandonment of both their low-dose exposure study (or, as it turned out, their single exposure/Spill – simulating study, either). As had been the case with the NIOSH presentation in 1973, and as had more recently been the case with the low-dose and catastrophic exposure simulation studies, the VCRC originally decided to do the honest thing. The group actually voted that TCA should be allowed to study the oldest group of workers whose records had supposedly been “recently discovered” at Carbide South Charleston.
The bad news was that (as had also been the case with he NIOSH presentation and the low-dose and single dose studies) that, by the time of their 2/13/75 meeting, the Vinyl Panel had come to their senses (or were brought to their senses by their management with its eye on the bottom line) and decided that dishonesty and fraud would be the best policy for them to follow after all.
Even as of today, records from the oldest group of workers at Carbide South Charleston that at least existed on 2/13/75 have never been used in any published follow-up study. Although the recommendation of the Panel’s Research Coordinators at this at this meeting was that TCA incorporate in its study the oldest group of workers from South Charleston, this has never happened. Instead, as will be shown, the VCRC and the Panel went on to fund a study that included only the most recently exposed workers from many of the most recently built, and larger, vinyl plants.
This amounted to the second time since 1973 that the deliberate decision was made not to study the older of the available records from South Charleston, but to study only the records of the more recently employed workers. The deliberate decision of the MCA-coordinated vinyl manufacturers to exclude from the TCA study the thousands of workers employed at Carbide South Charleston before 1946 has never been revealed in any discussion of the MCA/CMA cohort that has ever occurred.
At the time of the 2/13/75 meeting of the Vinyl Panel, Union Carbide’s PVC operations in South Charleston, West Virginia, were the oldest in the country – with complete records on vinyl chloride exposed workers going back to the 1920’s. However, like almost everything else of importance with regard to the TCA study, the exclusion of the oldest group of the oldest Carbide workers (thousands of them) from South Charleston has been maintained in confidence by every CMA-coordinated vinyl manufacturers that knows about them.
The purpose for this continued concealment was and is in order to allow the MCA Group to continue to exert similar improper and undisclosed influence upon the substantive content of scientific studies they conducted or funded without detection.
On 2/13/75, The Panel voted to require TCA to analyze their mortality data in terms of the type of plant at which the deceased workers were employed. However, in 1976, after the one-year observation period for the IBT study ended, the study was put on an infinite hold and suppressed.
Although at its 2/13/75 meeting, the Panel recognized that no reliable historic measure of vinyl chloride exposure levels existed, the group then agreed to require TCA to massage the so-called exposure data into misleadingly precise ratios, in order to ascertain which ratio would yield the result favored by the study’s industrial sponsors.
Such decisions never were reflected in any of the reports, in part, because of the expense involved and, in part, because Dr. Gaffey from TCA advised the Panel that the requested statistical manipulations would unlikely produce anything that would be useful to the industry. At the time of its 2/13/75 meeting, the MCA-coordinated vinyl manufacturers were advised, yet again, that Dr. Rall’s committee still had not advised Dr. Torkelson or Dr. V.K. Rowe, anything at all about the MCA Toxicology Program; nothing had changed.
However, time apparently pressed, and, with or without the presupposed recommendation of the Rall Committees of the NIEHS, the MCA-coordinated vinyl manufacturers just went on and aborted both the low dose and single dose studies anyway – with no further need for even the pretext of legitimate advice from anyone on the advisability of scrapping the committed toxicology programs, after all.
At least from the time of this February 13, 1975 meeting, the members of the Vinyl Panel have been aware that their previous and on-going participation in the European secrecy agreements and alleged misrepresentation with regard to the nature and extent of the hazards posed by vinyl chloride were already the subject of significant and potentially very costly personal injury litigation, and would pose a continuing threat to the MCA-coordinated vinyl manufacturers in the future.
Notwithstanding this knowledge, however, and with the specific intent of destroying relevant evidence and obstruct justice, the defendants in the Ross case have destroyed records they knew was and would be relevant in future years continue to be relevant to such litigation. The purpose for destroying the records was in order to conceal evidence of past misconduct, minimize their potential exposure to Tort liability, and in order to allow similar acts of misconduct on the part of the Vinyl Panel to escape detection in the future.
On 2/13/75, the VCRC officially postponed revising SD-56, for yet another time. They also received reports to the effect that PVC dust was a potent agent for producing pneumoconiosis at the same meeting.
As of 2/13/75, the members of the Panel all knew the secrecy agreement was still in effect. They had been apprised of this specifically just the previous December. Without revealing their knowledge of the recent reports they had received indicating that exposure to PVC dust posed a risk to workers they secretly recognized was as great as chrysotile asbestos, the VCRC decided to make discrete inquiry from American companies manufacturing paste-grade PVC powders.
As will be shown, in 1979 the Vinyl Panel would receive secret reports from the Europeans about studies of workers at ICI’s Hillhouse plant that had been conducted by the University of Edinburgh. By this time, the Vinyl industry’s secret understanding of PVC dust related lung injury had grown to include knowledge of a ventilatory defect that both the European and American Vinyl companies characterized as on the order of smoking a pack of cigarettes (20) per day.
This was, of course, concealed and remains concealed to this day.
The motive for concealing the 1975 reports the Vinyl Panel received indicating PVC dust was as biologically active as asbestos and the motive for concealing the University of Edinburgh studies demonstrating what both the European and American vinyl companies themselves characterized (in private) as a hazard to the lungs on the order of cigarette smoking was: (1) out of their own financial interest in preventing yet another hazard from working in the PVC industry, PVC dust, to be identified, in addition to VCM, and (2) also because such studies were still covered by the Panel’s secrecy agreement with the Europeans – even after 1974.These reports came from unpublished European experiments that the Panel members concealed then and continue to conceal today.
2/18/75
On February 18, 1975, the SPI VCM / PVC Producers Group decided whether a writ of certiorari should be taken from the decision of the Second Circuit. The SPI VCM / PVC Producers Group went on to hire the firm of Ruckelshaus, Beveridege and Fairbanks as counsel on EPA matters.
3/5/75
By March 5, 1975, the members of the American Vinyl industry were aware that the tank car placarding procedures still universally in use were potentially extremely misleading. While they implied that empty VCM cars were actually empty, since a heel of VCM was left in empty cars and unless the tank cars have been gas freed, the “Cancer-Suspect Agent” should have appeared from the standpoint an occupational safety.
3/18/75
On or about March 18, 1975, the MCA-coordinated vinyl manufacturers were aware that the permanent OSHA VCM Exposure Standard was to go into effect on April 1, 1975, and that a requirement of this standard required the medical surveillance of employees exposed to VCM above the “action level” of 0.5 ppm.
Although the vinyl chloride standard made no reference to exempting non-permanent employee medical testing, the MCA-coordinated vinyl manufacturers agreed that they should have. As a result, the medical and legal departments of the involved companies collectively agreed that exempting employees who had not been hired on a permanent basis was the real intent of the law; however, no approval for this “interpretation” was sought from OSHA.
The only risk in making this interpretation was the risk of a serious Violation charge by OSHA, and the potential of a shut down of work until all casual or temporary people were given a physical examination. In addition, publicity by the media related to issuance of an OSHA citation could result.
4/4/75
On April 4, 1975, abstracts of papers on VCM presented at the New York Academy of Sciences, March 24-27, 1975, were mailed to the MCA-coordinated vinyl manufacturers by the MCA.
Included was the study conducted by NIOSH that the MCA-coordinated vinyl manufacturers had been told had resulted from the study of workers employed at the BFG plant in Louisville (plant that was included in the original TCA study) as well as Firestone workers at Pottstown, PA (a plant that was not included in the original TCA study, as well as 2 other plants. .
The study was entitled “NEOPLASTIC RISK AMONG vinyl chloride POLYMERIZATION WORKERS,” and published by Richard J. Waxweiler, MSIE; William Stringer, MS; Henry Falk, MD; Coleman Carter, MD; James Jones, BSChE; Joseph K. Wagoner, SD Hyg; NIOSH, CDC. This Waxweiler cohort (and the Wu paper, too) was known to be comprised of persons working at four separate polyvinyl chloride (PVC) polymerization facilities. NIOSH had limited its study to workers with more than five years of exposure and for whom ten years or more had passed since their first exposure. This restriction was imposed to avoid bias due to selection or due to insufficient latency for occupationally induced malignancies to become clinically manifest.
When mortality of the cohort was compared with that of U.S. white males, the results demonstrated a close agreement with previous animal bioassay studies and human epidemiological studies in terms of excess risk of cancer and site distribution of those cancers.
The companies were also sent abstracts for an article entitled ONCOGENIC AND MUTAGENIC RISKS IN COMMUNITIES WITH polyvinyl chloride PRODUCTION FACILITIES, authored by Peter F. Infante, who was then employed by the Ohio Department of Health, and, later, NIOSH. The results of a preliminary investigation indicate that residents of the three Ohio communities with polyvinyl chloride production facilities gave birth to a significantly greater number of children with malformations during the period 1970-73, as compared to the expected, based on occurrence in the entire state. The rate of malformations in the index cities also was significantly greater than the rate in the balance of the counties in which these cities were located. Other county-city combinations of similar size revealed no significant differences in malformation rates. Most notable among specific birth anomalies were those involving the Central Nervous System: 5.62 expected versus 17 observed.
These preliminary findings did not link the presence of polyvinyl chloride production facilities with the increased occurrence of malformations, but indicate the need for further study of possible contributing factors.
4/7/75
On or about April 7, 1975, a key Federal official and the Chairman of the ACGIH TLV Committee [Dr. Herb Stokinger] denounced scientists at the National Cancer Institute as “a lot of old fogies” and described as the OSHA standard as “an irrational” Government requirement that workers be exposed to virtually no vinyl chloride.”
5/2/75
On May 2, 1975, Torkelson of Dow wrote to the Technical Task Group on VC Research asking the companies to try to provide better estimates of the actual exposures of their workers to vinyl chloride to provide data that would relate cancers to exposure concentrations.
This was explicitly tied to EPA interest in fabricator and neighborhood cases. The companies sponsoring the MCA-coordinated study on VCM-PVC workers by Tabershaw Cooper Associates (TCA) have on several occasions since 1974 discussed the possibility of attempting to somehow define the VCM exposures of workers in the study more precisely.
This matter had become increasingly important since the EPA was attaching considerable significance to the alleged fabricator and neighborhood cases. While there was considerable reason to question the relationship in these alleged cases to vinyl chloride, the fact remains that there was little published quantitative data to show the relationship of tumors to exposure concentrations.
The notable exception was Dr. B.B. Holder’s (The Dow Chemical Company) testimony at the OSHA hearings in July 1974), who testified “Therefore, I’m asking that you seriously consider whether your company can better quantify its estimated exposures. We would suggest that attempts be made to retrospectively determine estimated exposures Using the following levels: greater than 2000 ppm; 200-2000 ppm; 20-200 ppm; less than 20 ppm.
Obviously, excursions frequency, duration, and maximum concentrations must be considered in evaluating the exposure. Time weighted averages should be calculated for the time spans as defined by the Tabershaw Cooper Study taking into account changes in exposure concentrations over the years.
Two thousand ppm was recommended because it represents the approximate odor threshold; two hundred ppm appears to be a “break point” in clinical and/or laboratory findings; below twenty ppm should include most fabricators.
In order for each company to do this they were told to use guidelines to estimate exposures suggested by the CMA group, including the following:
1. Fabrication workers with few exceptions were to be classified at a level below 20 ppm.
2. The odor threshold for vinyl chloride was to be considered around 2000ppm, and not 260 ppm as the sponsors were told they had relied on in making their original exposure estimates.
3. Explosimeters were often calibrated to read a certain fraction of the lower explosive limit (LEL 3.5-4%). Therefore, knowing what a company’s past operating procedures might make it possible to get some idea of exposure levels involved. Medical, safety and first aid records as well as other company records were said to attest to accidents or incidents of dizziness and unconsciousness.
5/16/75
On May 16, 1975, Dr. John T. Edsall, a Harvard professor, who was at the time the head of the American Academy for the Advancement of Science (A.A.A.S.) wrote an article, entitled “Scientific Freedom and Responsibility” that discussed “The case of Data Suppression Concerning the Carcinogenicity of vinyl chloride” in Science Magazine (the official organ of the A.A.A.S).
Because the A.A.A.S. was a widely respected organization and that had no history of making extreme or irresponsible statements about industry and because Dr. Edsall (the “father of the hydrogen bomb”) didn’t either, the fairly well documented charges raised in Science magazine was of particular concern to the MCA-coordinated vinyl manufacturers.
5/30/75
On May 30, 1975, the report form TCA’s Supplementary epidemiologic study of vinyl chloride workers again indicated an increased incidence of brain cancer in the exposed cohort. The study had been commissioned on Nov. 4, 1974 by MCA for the specific purpose of extending the mortality study that was the subject of TCA’s May 3, 1974 report. Brain cancer then accounted for about 42% of the deaths in the TCA cohort as compared with about 22 percent in U.S. male deaths generally. There was reported to be no substantive change in the patterns of cause specific mortality by duration and level of exposure.
6/15/75
On June 15, 1977, Dr. Torkelson wrote to MCA (Seawell), informing the MCA-coordinated vinyl manufacturers that, while he agreed with the plans for presentation of the report in principle, after polling Research Coordinators, it was decided that the previous EEH report still wasn’t quite up to the standards of the MCA-coordinated vinyl manufacturers.
Dr. Cooper should be told that how something was said was often as important as what was said.
However, the MCA-coordinated vinyl manufacturers had considerable question about the timing of the (EEH presentation. The MCA emphasized to Dr. Cooper the need for each company to consult with their management before deciding whether the EEH was ready, at last for public consumption.
7/18/75
On July 18, 1975, Albert Clark of MCA responded to the Edsall A.A.A.S. article published in Science magazine May 16, 1975, alleging that the MCA-coordinated vinyl manufacturers had suppressed data on the carcinogenicity of vinyl chloride.
Among other things, MCA argued that, no matter what NIOSH said, NIOSH was in fact fully informed at the time of the MCA delegation’s presentation to NIOSH on July 17, 1973.
7/25/75
Dr. Torkelson chaired both the SPI and the MCA vinyl committees and so it was easy for him to arrange a meeting with MCA and SPI cooperation in order to present data to support the safety of PVC resins. The FDA was under pressure by Nadir’s Health Research Group to ban the use of PVC in food applications.
9/8-9/75
On September 8 and 9, 1975, the VCRC and the Vinyl Panel ([66]) [67] [xiii] met at the MCA Conference Room in Washington, D.C.
The VCRC received proposals from Dr. Tamburro at the University of Louisville (the Panel would go on to fund UOL research in order to serve their interests in employee relations and public relations).
Although there was a lot of talk about the Panel’s medical interest in “early detection,” it was hardly sincere. As hopefully well demonstrated elsewhere, the companies on the Vinyl Panel did all they could do to avoid even “late detection,” of occupation disease resulting from vinyl chloride exposure, and the Panel certainly was never truly serious about attempting to employ early detection techniques to identify incipient vinyl chloride disease early and, perhaps, while it was still treatable.
The Panel all understood that the purpose for the UOL studies was to meet the need of the vinyl industry to demonstrate their concern for their employees without the risk of finding any more additional disease like they had found in the TCA studies.
This was the openly discussed purpose for the UOL research program. In order to be able to claim they were doing anything to study VC related disease, the Panel had to sponsor something.
By sponsoring the University of Louisville, through Dr. Tamburro, the vinyl industry created their own experts that they intended to use to defend future tort litigation, in which they would serve as both disclosed and undisclosed experts in the future.
The UOL was requested to prepare what was referred to as their “shopping list” of projects UOL might perform for the MCA Group. The VCRC received a compilation of new results including the “old” Union Carbide records (quotation marks in the original) which allowed them to know what the results of adding this “old” group of workers would be prior to the group’s final decision as to how to group them. In this manner, the group was able to predict what the new study would reveal prior to even allowing the EEH report to be submitted to them in draft form.
9/9/75
On September 9, 1975, the Vinyl Panel met at the MCA Conference Room in Washington, D.C.
The MCA-coordinated vinyl manufacturers discussed their plans to discontinue any further epidemiological study of persons exposed to vinyl chloride and the current studies at TCA were to be completed in early 1976.
The MCA-coordinated vinyl manufacturers were also advised that the teratology studies Dow had conducted were complete.
The Panel was also advised of reports from Europe indicating that recent secret and unpublished epidemiologic studies conducted on PVC workers that was considered to show that PVC dust was as active as chrysotile asbestos in the causation of pneumonoconiosis.
As part of the previously described scheme to prevent the conclusion of the IBT studies as called for by the protocols, the VCRC voted that the completion of the IBT study would be continued indefinitely. The pretext for the MCA-coordinated vinyl manufacturers to put the IBT study on infinite hold, was as follows: The MCA Group had just decided, at the last minute and just before IBT’s final report was due, to abandon the definition of the end of the study, as set forth in the protocols, and, abandoning the protocols, follow what was referred to as the “practice adopted by Dr. Maltoni” of not terminating the observational period of the study at the end of two years (or at the end of any other fixed time).
The animals in the European experiments were allowed to live out their natural life spans and were not sacrificed at the end of any specific time. This was done in order to allow more time for observation and determination of vinyl’s latency. However, this makes no sense when there were only a handful of animals left alive at the time the end of the study was redefined when, at the end of the second year, the protocols called for all of the animals to be sacrificed.
Remarkably, only a few months before, (before the need to abort the IBT studies was fully appreciated) the group had specifically voted to the exact contrary, requiring the sacrifice of the surviving animals as called for by the protocols set years previously and recently reconfirmed.
In addition to the MCA-coordinated vinyl manufacturers’ last-minute 180-degree about-face on whether to end the study as called for in the contract, the pretextual nature of this last minute modification of the protocols can only have been apparent to all Panel members. At the time they made this decision to continue the IBT studies until the last animal died, a grand total of only five rats and two hamsters remained. The excuse the group used for its deliberate decision not to abide by study protocols and to hold the surviving animals until their deaths was clearly pretextual. Maltoni’s reason for allowing the animals to live out their natural life spans was to allow the experiment to detect cancers that occurred after long latent periods. This reason makes little or no sense when there were only a mere handful of animals left alive.
The Panel’s unanimous decision to pay IBT fifteen cents per day each for two hamsters and five rats was not made for any such legitimate reason. The reason for breaching protocols had nothing to do with scientific concerns and everything to do with the Panel’s well-founded concerns about the integrity of their studies at IBT.
The Panel fully realized, that under the circumstances, no credible report could possibly issue from IBT. The Panel used its recently found preference for terminating the study as in the Italian studies as a pretext to put the problems at IBT to rest once and for all and terminate the study. Even after these few remaining animals died, the Panel still did not require IBT to issue a final report.
11/20/75
On November 20, 1975, Dr. Hal B. Lovejoy, M.D. discussed the idea of utilizing older employees at PPG’s VCM plant in Lake Charles, to take advantage of the latency effect of vinyl chloride related diseases.
Although the frequency of cancer increases with age, and although one has to be reasonably healthy to survive to age 50, the frequency of cancer would be greater and it would be difficult to prove the exposure to a carcinogen was not the cause if one of them developed cancer. Shipping employees were already being moved every six months at PPG’s VCM plant in Lake Charles. Dr. Lovejoy wondered out loud it might not be reasonable and possibly very beneficial to move operations personnel out of vinyl and other possible cancer producing exposures after they had worked in those areas for one, two, or five years. Maintenance personnel were to be rotated through these areas as well.
On 12/1/75, Zeb Bell who represented PPG on the vinyl chloride PANEL at the time, replied to Dr. Lovejoy’s proposal that what Dr. Lovejoy proposed would be true only if one could be sure that the lesions caused by vinyl chloride and similar carcinogens, were reversible, and at what stage. It was presumed that 10 years was the cut-off period; however, Bell admitted that there was nothing to assure that shipping employees, in 40 years, with 5 years (or 5 months) of vinyl chloride exposure, would not develop cancer.
Dr. Bell said that if PPG knew the lesions were reversible, they would agree. However, to increase the number of workers at risk for the sake of recovery appeared promising, but was a cause for reasonable concern.
12/10/75
On December 10, 1975, the VCRC met at the MCA Conference Room in Washington, D.C.
The VCRC[68] were advised that birth defects had been detected at rates that were higher than expected by both NIOSH and the State of Ohio.
The MCA Group[xiv] would go on to spend a small fortune attempting to discredit these and similar studies, but would not risk doing similar studies of their own. It would obviously be desirable for the MCA-coordinated vinyl manufacturers to conduct their own epidemiologic studies of birth defects, if the methodology employed by Dr. Infante and others did not suit them.
The MCA Group never conducted birth defect epidemiology for the same reason the MCA-coordinated vinyl manufacturers never sponsored “no effect level” and single dose studies they had made the commitment to perform: The concern was that good science might end up in bad hands. If the MCA’s own studies were seen as confirming the independent scientific evidence, it would be much more difficult to argue doubt existed, and, of course, a primary purpose, if not the primary purpose, for most MCA-coordinated scientific studies was in order to raise doubt.
For reasons similar to those set forth above, the Panel also made a considered decision not to investigate the possible relationship between VC exposure and heart disease. Although the Group had no information to contradict the Swedish studies they were discussing and good reason to believe them, the investigation of these for no better reason than that the Group felt no threat from these studies because of what they perceived as a lack of interest elsewhere.
The VCRC voted to authorize the payment of $7,840 to IBT for holding the exposure chambers ready for 14 weeks while the Group pretended to seek consultation with Government officials (the NEIHS “Rall Committee”). The reason for dropping the low-dose and single dose studies was that the MCA-coordinated vinyl manufacturers did not want to risk confirming, with their own studies, similar reports from other sources that the Group realized they could no longer reasonably hope to contradict or call into question. Absent such an “upside” possibility, the MCA Group saw no reason to conduct studies with such an obvious potential “downside.” The group recognized the potentially great risk of performing the studies they had committed to perform and so they didn’t. Confirming bad news the Panel could see was going to come down the pike sooner or; later no matter what they did was the last thing the Panel wanted to do.
Although the Group openly recognized that it was a Violation of the IBT protocols (and, in fact, even the Vinyl Panel’s own contrary decision of several months earlier), the group decided to “adopt the method of Dr. Maltoni” and, in effect and intent, actually pay IBT not to complete the study and never to complete it.
The Group decided to authorize the payment of an additional $20,000 to IBT on account of so-called extraordinary expenses that they were not contractually bound to pay and which had not even been itemized by IBT, as they openly recognized.
The VCRC surveyed the responses to a questionnaire on PVC dust they had sent to participating American vinyl manufacturers and decided there would be little they could gain from looking at old records and that a new perspective study would be more appropriate. However, as a result of concerns the Vinyl Panel had as a result of the confidential report it had received that PVC dust had an effect on the lungs similar to asbestos, the Group decided not to do anything, and never did. (By the end of the 1970s, the MCA-coordinated vinyl manufacturers had knowledge of a respiratory defect caused by PVC dust they considered to be on the order of cigarette smoking. This provided even more reason for never studying the effects of exposure to PVC dust to American Vinyl workers.)
12/11-12/75
The Panel voted to accept the VCRC recommendation to prevent IBT from issuing the final report it was supposed to render (using the guise of a recently developed fondness for Dr. Maltoni’s method of determining when the observational period of the study was to end). The Panel used last minute undisclosed protocols as a pretext for burying the IBT studies, extending the completion date for the doomed IBT studies. The MCA-coordinated vinyl manufacturers agreed to pay five thousand dollars to make this change in the protocols – even though, as previously shown, only five rats and two hamsters remained alive at the time. This would bring the cost of letting these rodents live out their natural lives to almost one thousand dollars per rodent (if we assumed the belated adoption of Maltoni’s methods was actually in good faith).
The Panel received copies of TCA’s 8/28/75 progress report and were specifically advised, if they did not already know, that the original cohort from South Charleston was to be intentionally limited to persons who had only been hired a short time before the study began. The Panel also agreed that even their attempt to rectify this situation was going to be biased the same way and by more or less the same manner as the original study had been. Now, instead of excluding every worker who had been employed at the plant between the early 1930s and the mid-1960s, the Panel decided to exclude just the oldest part of the cohort from South Charleston – all the workers employed at South Charleston before 1946, and an unknown number of workers employed thereafter, effectively eliminating almost two-thirds of the available old records (and the oldest two-thirds at that) the group had previously made a public commitment to study. Although the MCA-coordinated vinyl manufacturers knew the distinction was contrived and made solely in order to – they thought – make exposure to VCM appear to be less dangerous than it really was by exculpating VCM and copolymer operations at the expense of implicating PVC operations – the Panel decided that companies participating in the TCA study were to be allowed the unrestrained right to mischaracterize the plants in the study as one of the following: a monomer plant, a polymer plant, or a copolymer plant.
Because many, if not most, plants did not fit any of these three definitions, the request for each company to characterize such plants (including the Monsanto VDC plant in Houston, TX, for example) was on its face a request for the companies to mischaracterize their plants. If they didn’t already know, at the time of the 12/11-12/75 meeting, each company represented on the Panel was specifically informed that one of the largest and oldest PVC plants in the country – the Firestone plant in Pottstown, PA – had been completely excluded from the original study (although, as previously shown, Pottstown had supplied workers to the Waxweiler cohort). The Panel would eventually allow a select population of workers from that plant to be included in the CMA study. However, this was only after the University of North Carolina had completed its study of that same plant. Perhaps, significantly, putting the UNC first would thus identify the workers the Panel would have to include in the TCA study in order to falsely minimize the reported cancer risks from that study.
Eventually, in 1982, a CMA sponsored study that included some of the workers from Pottstown, PA was published. However, the Pottstown plant would completely disappear again after 1982, a fact that was consistently concealed by the MCA Group who continued to hold their studies out as being an industry-wide study that subsumed all previous U.S. studies of the American vinyl industry.
The Panel received confidential reports that a study of PVC fabricators conducted by Organizational Resource Counselors (ORC) had shown excess rates of diseases of the digestive tract, diseases of the circulatory system, and cancer of the liver.
The Panel received IBT’s 23-month status report, including specifically IBT’s reports of gross lesions that did not reveal the existence of the VCM related brain cancer that IBT had actually found. This incomplete 23-month IBT report was submitted to numerous agencies of the U.S. Government. Although the sponsors had already decided not to request a final report from IBT that might otherwise have revealed the brain cancers, as well as other matters – including the improper conduct of those studies – that it was in the financial interest of the Vinyl Panel not to reveal.
On or about the time of the December 1975 Panel meeting, the Panel learned (and then concealed) evidence they possessed and did not appear to question, indicating that PVC dust was as biologically active in causing nonmalignant respiratory disease as chrysotile asbestos. For this reason, the Group decided against initiating any dust inhalation studies of their own. The secret news from Europe was bad enough.
The Panel then discussed their true motivation in conducting the UOL studies they planned to initiate. The Panel was concerned that the industry might be perceived as having failed to take affirmative steps to protect its workers. Because the pretext for these studies was the need for “early detection” of incipient disease, the UOL studies were appropriate; they served the Group’s interest in employee and public relations without risking anything (i.e., there was little or no risk that any of the studies the MCA sponsored at the UOL would reveal anything that might cost the companies a lot of money). Further, the UOL study was careful not to even recommend anything that might prove “dangerous” for the industry.
The Panel agreed that there should be a division of effort between the Panel and the SPI, and that the SPI was to be responsible for FDA and related product-use regulation, while the Panel’s activities on behalf of the vinyl industry were to be concerned with developing scientific evidence related to ambient and industrial vinyl chloride exposures.
The Panel concurred with the VCRC recommendation to delay revising and reissuing SD-56.
12/11/75
On December 11, 1975, the Vinyl Panel met at the MCA Conference Room in Washington, D.C.
The Panel authorized payment to Dow for overruns not covered under their contract for the Dow metabolic studies.
Having suppressed the TCA report the Group had received earlier, the Group discussed plans for TCA to submit another draft and then another final report on the study population the MCA-coordinated vinyl manufacturers had since decided to supplement with the so-called old Carbide South Charleston workers. (Which cohort had recently been sanitized of the workers who had been employed the longest before the study began and who were most at risk for developing cancer from vinyl chloride exposure.)
However, no acceptable report would come from TCA until the next September; even then, as will be shown, the September 1976 report would also be suppressed because it did not misrepresent the nature and extent of the hazards posed by exposure to vinyl chloride the way the sponsors had intended that it should.
Indeed, at least eight so-called final reports would be suppressed before the Panel would finally allow one to be published in 1982. Without having done any research of their own, the VCRC declared that the recently reported increased incidence of birth defects in wives of PVC workers to have been discredited for no better reason than that “reputable epidemiologists such as Dr. Gaffey,” supposedly, were not “putting much stock in them.”
The VCRC made a commitment to publish an IBT report on histopathology at this meeting, but they never did so. Further, the Panel agreed to allow the publication of the cytogenetics study the Panel had previously allowed Dow to conduct by physically removing so many animals from the ongoing IBT study that the IBT study was even further compromised. (The fact that Dow took animals from the IBT study to perform cytogenetic studies to combat recent reports of chromosomal aberrations in vinyl chloride workers has never been disclosed in connection with either study).
The Panel specifically discussed the fact that only 5 rats and 2 hamsters had remained in the IBT studies at the time the MCA-coordinated vinyl manufacturers had agreed to preclude the submission of IBT’s final report through use of the previously described pretext that there was some sort of sincere desire to belatedly adopt Dr. Maltoni’s end of study definition as their own.
The Panel discussed that the ongoing low-dose studies then being conducted in Italy by Dr. Maltoni would not be published in the near future until such time as the SPI (who was sponsoring these studies) put their release of Maltoni’s study results off “hold.” The SPI was trying to decide what to do with the disturbing new results from Dr. Maltoni’s studies, indicating the carcinogenicity of vinyl chloride at levels far below those previously reported. The Panel used the pretext that the Swedish study indicating cardiovascular involvement with VC exposure had many weaknesses to justify their decision not to conduct any investigation of vinyl chloride and heart disease. In fact, the real reason the studies were not pursued was the fact that they were receiving no pressure to conduct such studies.
1976