1981
The CMA-coordinated vinyl manufacturers became aware of an article, entitled “Neurological effects of VC workers” that was published Journal of Hygiene, Epidemiology, Microbiology, and Immunology.
1981
At the conclusion of its investigation of the so-called Texas City incident, the government determined that it was unable to prove a specific connection between VINYL CHLORIDE exposure and the Texas City brain cancer cases.
Carbide infuriated the government investigators at Texas City by publishing their own exculpatory report that ascribed the excess brain cancers to chance through the creative use of data Carbide possessed only because the government, unaware of Carbide’s intentions, had voluntarily furnished it to them.
March 1981
In March 1981, EHA made what it referred to as “A Proposal for the Update of the Epidemiological Study of VINYL CHLORIDE Workers” to the CMA-coordinated vinyl manufacturers.
However, the proposal was, basically, nothing but a document, entitled “Specification for Bids” that the CMA-coordinated vinyl manufacturers had themselves drafted.
As a result, the effect was that the EHA was giving back to the CMA-coordinated vinyl manufacturers their own proposal.
In accord with the CMA’s “Specification for Bids,” the EHA proposal claimed that, in cases where the designation of jobs involving exposure to VCM designation had not been made according to the protocols (and even the most rudimentary quality control procedures), such designations had been made by staff members at individual study plants, or by corporate industrial hygienists, after a comprehensive search of all plant records and using what were essentially the same methods that TCA and EEH had employed.
Additionally, the cohort was said to consist of employees from 37 individual plants operated by 17 separate companies, and that only a small portion of the cohort had been identified by a study number with no personal identifiers made available to the investigators. The CMA-coordinated vinyl manufacturers were specifically aware that at that late date it was certainly impossible to determine actual exposure levels experienced by workers in the 1940’s, 50’s and 60’s with any greater accuracy than the 1973–1978 era exposure estimates – and everyone recognized those exposure estimates were misleading, and all but worthless (at least for any legitimate purpose).
It had never been any secret that actual exposure levels for workers exposed prior to 1974 simply were not known, not in the 1973–1978 era, and certainly not in the 1980s.
Because of the recognized serious deficiencies in prior exposure estimates, EHA absolutely refused to use the old exposure classification system in their (seven-year) follow-up study. Rather, EHA used length of employment in jobs with potential exposure to stratify the cohort into exposure categories.
3/24/81
On 3/24/81 , Dr. Stafford forwarded J.T. Barr’s “Vinyl Chloride” paper (and actually propaganda for the AIHC Risk Assessment Committee) to Dr. Doll.)
9/4/81
On 9/4/81 Dr. Stafford (ICI) wrote Doll because Dr. Munn from Monsanto had told him Doll was interested in the ICI Angiosarcoma registry. Stafford admitted that he was not an epidemiologist or medically trained person but only an industrial chemist.
Stafford had been publishing the registry normally every six months for five years and enclosed his 8/17/81 version of the ICI registry.
October 1981
In October 1981, the CMA-coordinated vinyl manufacturers caused W. Clark Cooper to publish an article in Environmental Health Perspectives.
In October 1981, Maltoni published conclusions from the lengthy series of studies he had performed for the European vinyl industry beginning ten years earlier, in 1971. The conclusions were that VINYL CHLORIDE caused cancer in all of the wide variety of animal systems tested, and that VINYL CHLORIDE was a multipotential carcinogen in humans and in every animal species tested causing different types of cancer at different sites.
11/30/81
At some time before November 1981, Conoco shared the results of the validation studies it had conducted for 3-M dosimeters used for monitoring VINYL CHLORIDE with the manufacturer of those badges, 3-M.
Neither prior to, nor since that time, has 3-M ever warned purchasers of its dosimeters not to use them to monitor VINYL CHLORIDE, and the American vinyl industry has succeeded in almost totally concealing the extreme peril of relying upon charcoal-based monitoring results.
The MCA-coordinated vinyl manufacturers, for their part, almost completely succeeded in suppressing the scientific data they had developed since 1974 – data that the companies all recognized demonstrated that Using charcoal for VINYL CHLORIDE monitoring would result in consistent underestimates of the true exposures of any worker monitored Using those methods.
The companies have known since 1974 that any assumptions about typical exposure levels that relied upon charcoal monitoring methods were likely to be unfounded, and would almost certainly result in gross underestimates of actual employee exposure levels.
Early 1982
The CMA-coordinated vinyl manufacturers admitted that, since 1971, the Vinyl Panel (under different names) had, on their behalf, developed research programs studying possible health effects from VINYL CHLORIDE exposure, reviewing and evaluating the results of all other available studies, and representing MCA and CMA before all federal agencies on all matters relating to safety and health issues arising from the production, reaction, release, packaging, storage, handing, or use of VINYL CHLORIDE.
In early 1982, EHA finally signed a contract to update the previous epidemiologic studies the CMA-coordinated vinyl manufacturers had performed.
However, the contract between EHA and the CMA-coordinated vinyl manufacturers was broken into two separate phases. At the conclusion of the first phase, EHA was required to surrender to the CMA a compilation of all the epidemiologic raw data EHA had assembled as the “work-product [computer] tape” of the CMA-coordinated vinyl manufacturers. The second phase, during which the data would actually be analyzed, was to be a separate contract and was not covered in the 1982 contract.
The CMA-coordinated vinyl manufacturers provided that the second phase would not necessarily be granted to EHA, and would take place only after EHA had placed all of the raw data in the possession of the CMA-coordinated vinyl manufacturers to assist them in designing the epidemiologic study in whatever manner they saw fit.
1/27/82
On January 27, 1982, the CMA Vinyl Panel[xxii] met in the Lobby Conference Room of the CMA Headquarters in Washington, D.C.
The same vinyl companies that were designated “Vinyl Chloride Industry Representatives” at the previous meeting on November 14, 1980, had gone back to using the term VINYL CHLORIDE PANEL.
The purpose of the meeting was to facilitate the EHA “two-phase” update, a study that was conducted in two phases so that the CMA-coordinated vinyl manufacturers would not run the risk that the study would be performed honestly and with a predetermined protocol.
The Panel agreed with the VCRC that they should split the proposed update by EHA into two phases.
This “phasing” approach was unprecedented event in the history of studies sponsored by the CMA-coordinated vinyl manufacturers.
According to the unusual contract the CMA Group had negotiated with EHA, at the conclusion of “Phase I” of the study, EHA was supposed to tender its “work product computer tape” to the CMA-coordinated vinyl manufactures. Access to this “work product tape” at the conclusion of Phase I, would allow the sponsors completely uncontrolled access to the raw data, and also allowed the group to analyze the data according to methods the CMA group determined, after having full access to the raw data, would enable a the study to reach the CMA group’s predetermined result.
The phasing of this study enabled the CMA-coordinated vinyl manufacturers to have the ability to project the results of the analytic methods they would require their independent contractor to employ.
This was all for the specific purpose of facilitating the sponsors’ complete control of the study data, the analytic methods employed, and the results reported by a contractor that they intended would appear as “independent.”
The result of this two-phased approach was to effectively release EHA from financial concerns EHA certainly had about beginning a study without the benefit of, even, such basic information as the size of the cohort, or study population, involved.
The CMA-coordinated vinyl manufacturers specifically planned not to decide whether to even analyze the raw data collected during “Phase One” of the study, until they had been afforded the opportunity to review the raw data.
The CMA-coordinated vinyl manufacturers decided that an analysis of the raw data, in advance of the so-called legitimate beginning of “Phase II” would be employed. In this manner, the manufacturers decided whether they would be able to obtain the favorable results they wanted using any method of analysis that they might come up with after receiving the raw data on the work product tape at the end of Phase One. (In other words, the group decided to retain the ability to effectively kill the report they were sponsoring at the end of Phase One and never proceed with any Phase Two analysis at all, unless if they wanted.)
Since the CMA Group intended to conduct this study much as it had previous studies, that is, not according to any protocols, but more as a sort of “work in progress” whose design would only be known at the end of the study the protocols would be whatever the so-called rules were at the conclusion of the study, and completely after-the-fact.
The design of the study could, of course, only be described at the study’s conclusion, i.e., after the sponsors were finished manipulating the study design in such manner as they thought most likely to advance their political, economic, or public relations goals.
Like the previous MCA/CMA sponsored studies, the EHA “two-phase” study was designed for public relations purposes, i.e., for the sponsoring companies to use in regulatory and legal proceedings to support their positions, specifically, in order to falsify and misrepresent the nature and degree of the hazards posed by VINYL CHLORIDE.
In summary, the gross deficiencies, of which the Panel members had been specifically informed, at least as recently as 1980, including potentially enormous errors of cohort exclusion and inclusion, would remain factors biasing the EHA (two-phased) study, as well.
An unknown number of workers had been included in the study, who did not meet the cohort definition, because of inadequate exposure to vinyl chloride.
The Vinyl Panel thought it best that this not change.
At the same time there was another group of workers, whose size could not even be estimated, that had been improperly excluded from all prior studies.
The Vinyl Panel thought it best that this not change, either.
Even though workers with long and distant exposure histories were precisely the type of workers most at risk for contracting occupational disease from VINYL CHLORIDE, these workers had been the very type of worker shown most clearly to have been systematically excluded from the study from the outset.
The foregoing exclusion of workers was in direct contrast to the intentionally diluted cohort of workers that the sponsors had so carefully assembled in the TCA study, the manner thought at the time most useful to bias the study away from detecting significant disease (i.e., by including persons only recently hired, or who had not had sufficient exposure to VINYL CHLORIDE to put them at risk for contracting cancer).
By reason of the foregoing, EHA was intended by the sponsors to embark on what was euphemistically referred to as “Phase One” of their study without even having an idea of the approximate number of workers that would ultimately be included in the cohort/study group the sponsors had assembled without any independent oversight from EHA, or anyone else.
The CMA-coordinated vinyl manufacturers reiterated its cynical and corrupt decision not to either make any attempt to include in the study individuals inadvertently (or purposefully) excluded from the study or to remove from the study persons that had previously been improperly included in the study.
The decision to proceed with the analysis of a study the Panel members had been specifically informed was defective and biased away from detecting disease can only have been understood by all Panel members to be improper and fraudulent. By 1982, the Vinyl Panel had reason to know that it was precisely such workers that were systematically excluded from participation from all previous studies.
The systematic exclusion was intended to deceive anyone who might be forced to consider, or rely upon, the EHA study the CMA Group was sponsoring. Again, there had been no change whatsoever in the study population since 1975, except that it was dwindling.
The study population began dwindling after 1975 when a remarkable series of not so final Final reports had begun to come in from TCA and EEH.
Since 1973, and even to the present time, the considered and deliberate decision the Vinyl Panel made to massage the corrupt old TCA/EEH database, yet another time, has been maintained as a closely guarded secret by the vinyl industry.
Since 1973, the CMA-coordinated vinyl manufacturers have never made any attempt to correct even recognized mass cohort systematic inclusion and exclusion bias deliberately introduced into the study as a part of the cohort definition process.
For this reason, the sponsors were not even sure whether the study they were commissioning was to be the seven-year update the sponsors had been characterizing as a seven-year study for the last several years while the sponsors reached their decision.
The final decision didn’t come until some time before the January 1982 Panel Meeting, that those protocols would, in effect, not constitute protocols at all (i.e., there was no predetermined hypothesis, goals, materials, or methods).
Simply put, there were no protocols, and no rules, that inhibited the sponsors from bringing workers into the study, or, at any time, then, or thereafter, excluding workers from the study for whatever reasons they wanted. There were no deadlines or even binding due dates.
The Panel recognized, and openly discussed, the bifurcated study they were commissioning with EEH. Any report the sponsors would allow EHA to publish – even privately - was to contain absolutely no reference to anything that would allow an independent reader to assess the extent to which the facts and conclusions expressed in the report were at all independent, in any meaningful sense.
The MCA Group would eventually submit to OSHA the results of this study as EHA’s independent work, in 1986, and, in 1991, and the results were published in the open literature as ENSR’s independent work.
The SPI and CMA-coordinated vinyl manufacturers performed a critical review of an important article by Beaumont and Breslow, entitled “Power Consideration in Epidemiologic Studies of VINYL CHLORIDE Workers.”
The Beaumont and Breslow paper was an important study by two doctors at NIOSH that had looked at the power of the epidemiologic studies in the world’s literature that had been performed on VINYL CHLORIDE workers since 1974. The NIOSH doctors determined that the only studies that did not detect an excess risk of brain cancer were the studies that did not have sufficient statistical power to detect the excess in the first place.
On the other hand, the Beaumont and Breslow paper explained that epidemiologic studies that did have the statistical power to detect excess brain cancer in the groups of VINYL CHLORIDE workers that were subject to study, did, in fact, consistently demonstrate a causal relationship between VINYL CHLORIDE exposure and the development of primary brain cancer in the exposed study population.
The collaboration between the SPI and CMA groups had previously led to the CMA Group’s determination to forego a similar search of the world’s literature of their own. Such was the relationship between the CMA and SPI committees with responsibility for VINYL CHLORIDE health issues, that it was assumed that the CMA-coordinated companies would have access to SPI’s record collection.
The CMA Group was informed that Daniel Boyd & Associates would search their computerized file on VINYL CHLORIDE publications by any vinyl manufacturer or CMA vinyl committee.
The CMA Group discussed liaison activities with the SPI PVC Producers Committee. (This SPI committee’s membership overlapped that of the Vinyl Panel.) Throughout the years following 1974, a close working relationship existed between the SPI and CMA committees that had responsibilities relating to VINYL CHLORIDE health issues. These issues included not only collaboration on the attack on the “Power Considerations” article the group hoped to perform, but also with regard to a database created by Daniel Boyd & Associates that purported to contain all published and unpublished references to VINYL CHLORIDE in the World’s literature, as well as many other types of collaboration, only a small portion of which may reasonably set forth herein.
5/26/82
On May 26, 1982, the VCRC met in the CMA Lobby Conference Room in Washington, D.C.
At the time of this May 26, 1982 meeting, any member of the Vinyl Panel[xxiii][84] that didn’t already know that only certain select plants had been included in the original cohort definition, certainly found about it.
Dr. Wong provided each research coordinator (and, through them, each Panel member) with a complete list of the plants and company contacts from the original study.
It was decided that the Panel members would provide EHA with a new revised list of plant contacts for what was, by now, an eight-year update, as opposed to the five-year, or seven-year update it had been in the update’s previous incarnations. (By the time this study would ever be published in 1991, the CMA-coordinated vinyl manufacturers would cause the study to be published as a ten-year update. Even then, this publication would be considered a breach of contract by members of the CMA Group and, as will be shown, Dr. Wong would be called to account.)
The sponsors reiterated their previous decision to completely abandon the brain cancer case-control study, at least until the new data was collected, out of a well-founded concern that, unless something major happened to the data, any brain cancer case-control study they might conduct would most certainly result in the CMA Group finding out something they most certainly did not want to find (even if it was true), namely an association between the onset of brain cancer and exposure to vinyl chloride.
At the time of their meeting at the EHA offices in Berkley, California, Dr. Don Whorton predicted for the CMA-coordinated vinyl manufacturers that the brain cancer case-control study the CMA was about to start was probably going to show brain cancers were caused by VINYL CHLORIDE exposure, i.e., that the study would confirm the association that brain cancers were increased in the VINYL CHLORIDE exposed group.
Dr. Whorton (EHA) had made an “informal” assessment of the available data on the twelve brain cancer cases and then told the CMA-coordinated vinyl manufacturers that if they did decide to go ahead and conduct a case control study, it would almost certainly confirm what the vinyl manufacturers already knew, i.e., that the men with brain cancer were more likely to have had VINYL CHLORIDE exposure than an identical group of men who had not.
The CMA-coordinated vinyl manufacturers discussed their plan to prevent the EHA study from demonstrating what they implicitly recognized was the truth about the twelve brain cancer cases that had already been identified in previous studies, i.e., that the excess cancers were properly attributed to VINYL CHLORIDE exposure.
The VCRC decided to wait until the update of the study was completed before even considering continuing with the brain cancer case-control study.
According to the then current plan, if, and only if, the sponsors were unsuccessful in their fraudulent strategy for the updated study to “solve” their brain cancer problem using the same fraudulent methods they had employed in the previous studies, would the CMA-coordinated vinyl manufacturers even reconsider conducting a brain cancer case-control study.
9/22/82
Near the beginning of the Vinyl Institute (VI), Bart A. DeLiddo from BF Goodrich, wrote a representative of PPG notifying PPG of the recent escalation of criticism of PVC industry, and concern about divisions within industry that weren’t to the benefit of all members.
Mr. DeLiddo was particularly concerned about statements from Marshall Levy, a PPG employee who had criticized the use of PVC in wallpaper.
PPG went on to limit their production of a new alternative for PVC product, “envirez.”
1983
Dr. Wagoner published a study of critical analysis of the available information on the toxicity of VCM and PVC, published in Environmental Health Perspectives demonstrating that the target organs for VINYL CHLORIDE clearly included the liver, the brain, the lung, and probably the lymphohematopoietic system, and that most well-conducted studies of worker populations showed an excess risk of brain cancer that was 4 times greater than the expected rate, and which accepted a causal relationship for cases of angiosarcoma in communities located near PVC and VCM plants.
8/24/83
On approximately August 24, 1983, Industrial-Biotest (IBT) was convicted in a Federal court in Chicago, IL, among vocal advocacy for tighter controls on toxicity testing.
9/30/83
On September 30, 1983, the VCRC met in the CMA Reception Conference Room in Washington, D.C. [85] Having surrendered all the raw data EHA had generated during “Phase One” of what was then still an “Eight-year update,” the VCRC discussed serious problems with the EHA study, resulting from the enthusiastic exposure reclassification efforts undertaken by the CMA-coordinated vinyl manufacturers in recent years.
Everyone on the Panel[xxiv] on September 30, 1983, knew that there was no reasonable basis for the so-called “reclassification” efforts the “local contacts” at the plant level were instructed by their management to perform. Of course, if there was no data documenting past exposures available for use in 1973, there wasn’t going to be any data documenting pre –1973 exposure levels ten years later, in 1983, either.
It is considered a rudimentary quality control measure in conducting epidemiologic studies to take every effort to make sure that persons responsible for making exposure estimates do not know the vital status of the workers whose exposures they are classifying. It should go without saying that this was no ordinary study, and the wholesale exposure reclassification efforts that followed this meeting were made by persons who, by the very nature of the way the study was designed, most certainly knew the vital status of most, if not all, of the workers whose exposure history was being “reclassified.”
However, to the extent the Panel members were concerned about quality control issues in the design of their study at all, the Panel members were concerned primarily in evading, or somehow or the other, nullifying quality control procedures. (Quality control procedures might hamper concerted efforts to “fix” their study to do as little economic harm to the industry as possible, with no real concern for quality control, integrity of underlying data, etc.)
Concerns for quality control might be relevant to an epidemiologic study that was being conducted honestly, and whose architects and authors were willing to let the results fall wherever they would.
At the time of the September 30, 1983 meeting, the CMA-coordinated vinyl manufacturers claimed the study population (cohort) consisted of 10,173 employees from 37 individual plants, operated by seventeen companies.
At the September 30, 1983 VCRC meeting, the Panel was informed by Dr. Otto Wong that some overly enthusiastic companies had gotten carried away with the power EHA had granted them to “update the exposure histories” of anyone in the cohort that they unilaterally deemed should be reclassified out of the study’s cohort.
In the course of the meeting, the CMA-coordinated vinyl manufacturers discussed this peculiar, and highly unusual, problem that the CMA Group had gotten themselves into with the so-called reclassification effort. The “reclassifiers” at some plants had obviously “reclassified” workers on an ad hoc basis, and without consideration of whether the reclassification was consistent with the exposure classification received by other workers with exactly the same jobs.
As a result, it was brought to the CMA Group’s attention that some workers with a certain job were allowed to remain in the study, while other workers with the very same job were “reclassified out” of the study, willy-nilly and without any consideration for the accuracy or integrity of the resulting raw data. One notorious example (and an example of which the entire Vinyl Panel was made specifically aware) was a brain cancer victim who had, at least, previously been so fortunate as to unwittingly belong to the TCA/EEH/EHA cohorts the CMA-coordinated vinyl manufacturers had begun conducting in the early 1970s, as previously described.
As previously shown, under optimum circumstances, the reckless “anything goes” rules, according to which employers were allowed to reclassify employee occupational exposures, employers, belonging to the CMA Group, were able to completely reinvent any study subject’s work history, or exposure classification, if they wanted to.
The case of the “reclassified out of the cohort” brain cancer discussed at this meeting as a sort of case study had both acknowledged and demonstrated that the CMA-coordinated vinyl manufacturers did, in fact, want to reclassify dead workers out of the cohort, thus basically deal them out of the deck. This brain cancer victim had been reclassified. The reclassification took place after the employee’s death, and with the full knowledge on the part of the worker performing the reclassification that the reclassified brain cancer victim was dead.
Carbide South Charleston had submitted a reclassification “worksheet” on this deceased brain cancer victim to EHA. In turn, EHA then provided the Carbide reclassification sheet on the brain cancer victim to every CMA-coordinated vinyl manufacturer as an appropriate example of the new “reclassification problem” that had arisen.
Notwithstanding the previous classification of the deceased brain cancer victim as having had significant exposure to VINYL CHLORIDE, as part of the “reclassification effort,” this deceased vinyl chloride worker (a victim of brain cancer) had now been “certified” as not having been exposed to VINYL CHLORIDE at all. Since unexposed workers had no business in the cohort, the worker would be removed from the cohort, amounting to one less VINYL CHLORIDE related brain cancer case the CMA-coordinated vinyl manufacturers would have to contend with.
Despite the wide dissemination of information about this unusual “verification,” information disclosed to the CMA-coordinated vinyl manufacturers regarding the 1986 final EHA report, subsequently submitted to OSHA – or, for that matter in the report Wong submitted to the CMA-coordinated vinyl manufacturers, the CMA Group claimed Wong had breached his contract by publishing in 1991.
What had obviously occurred, and what every Panel member was meant to understand, when EHA sent the records on this South Charleston brain cancer victim to the MCA Group on September 30, 1983, was that the sponsors’ ad hoc, and after-the-fact, reclassification of this worker, who had died from brain cancer, was illustrative of a larger problem than that of an isolated brain cancer case, mistakenly overlooked.
Not very subtly, then, after giving the explicit example of the Carbide South Charleston brain cancer victim who had recently been defined out of the cohort, EHA would then go on to require the participating plant to reclassify the already reclassified workers, yet another time.
At the time of the September 30, 1983 meeting, each company represented on the VINYL CHLORIDE PANEL was made aware, if they didn’t already know, that at least 800 workers, who had been considered as exposed for purposes of at least nine final reports paid for by CMA preceding this latest version, had been systematically reclassified out of the study’s cohort by the sponsoring CMA Group.
To see this in its context, consider that the Vinyl Panel would soon deliberately rule that EHA would simply leave the 800 “reclassified out” workers in the study anyway.
The discrepancy was resolved by concealing it, in 1983, and in every published reference to this study since 1983.
As a result of the CMA-coordinated vinyl manufacturers’ ill-advised “reclassification efforts,” such as those described above, by the time of their September 30, 1983 meeting, the entire Panel had been made specifically aware that approximately 800 individuals, who had been identified as not having held a job involving exposure to VINYL CHLORIDE for one year or more prior to 1973, had been reclassified out of the cohort by the CMA-coordinated vinyl manufacturers’ reclassification efforts. Of course, this might prove embarrassing if it became widely known – over 800 workers had been literally reclassified out of the cohort!
The clear indication was, and is, that workers were most certainly improperly included in the industry-sponsored studies conducted prior to 1983, or were improperly excluded after 1983, or, as was truly the case, were improperly excluded both before and after 1983. EHA was directly implying – by including the single example of the brain cancer victim who had been reclassified as being unexposed – a warning to the CMA-coordinated vinyl manufacturers: More subtlety was required in the sponsoring company’s exercise of their ability to completely re-cook the books, if they wanted to avoid detection of their malevolent decision. After all, someone might actually notice if a worker with brain cancer, who been included in two published and an untold number of unpublished “Final Reports,” suddenly went missing after over 10 years as the result of the sponsors post-hoc exposure reclassifications.
This was certainly a cause for concern for the CMA-coordinated vinyl manufacturers: Discrepancies as gross as these might actually stand some chance of being detected.
The reclassification of the Carbide South Charleston worker with brain cancer as unexposed was provided to the CMA-coordinated vinyl manufacturers as an example of this misconduct. Indeed, this single example might alert a single careful reader to the undue and improper sponsor influence that had been brought to bear in order to dishonestly minimize the extent of the brain cancer risk attributable to vinyl chloride exposure that the study purported to demonstrate.
At the time of this September 30, 1983 meeting, the CMA-coordinated vinyl manufacturers had reviewed Dr. Wong’s report with him and requested certain modifications, not particularly major, and some not even substantive for a change. The Panel accepted the report.
Despite all the noise the CMA-coordinated companies would make in 1991, when Dr. Wong, for whatever reason, published the paper the Vinyl Panel had accepted at this 1982 meeting, without including their 1991 era claim that they had not been afforded an opportunity for pre-publication review was a preposterous claim that every member of the Panel and EHA (including Dr. Wong) knew was false.
The VCRC discussed the fact that persons who had been identified as deceased in the original study and weren’t reclassified hadn’t been subject to the extremely innovative reclassification effort the sponsors had recently completed, with the consequence that at least 800 people had been determined to have been improperly included in any of the many previous CMA/CMA sponsored “Final Reports,” both published and unpublished.
As a result, it only seemed “legitimate,” such as it were, to go ahead and reclassify all the folks that were known to be dead at the time the original study was conducted too, and that is just what the sponsors did over the course of the next several years. The CMA-coordinated vinyl manufacturers reclassified dead workers as part of an intentional effort to grossly alter the results of the American industry-sponsored studies for their own purposes.
What’s more, this was done with full knowledge that no additional data had actually become available for exposure assessments.
It is testament to the extent to which undue sponsor influence was the order of the day that, in this “never never land” – where the CMA-coordinated vinyl manufacturers had already been allowed to reclassify employee exposures after-the-fact and with full knowledge of their vital status – it almost made sense for the VCRC to allow the former employer of men who had been deceased, at least since 1972, would be allowed that same privilege.
The concern expressed by the CMA Group was that, unless the exposures of these dead men were reclassified like the rest, a possibility of exposure misclassification might arise. This rationalization was used at the same meeting at which the VCRC had just been informed that the first round of reclassification efforts they had valiantly undertaken had resulted in such gross discrepancies as the reclassification of over 800 workers right out of the cohort. (All, of course, as previously stated, without regard to any need for trivialities like new data to support the idea that a reclassification might even be appropriate, much less than such data ought to be used.)
In a manner nearly identical with that by which the Panel had resolved the issues of what to do about the proposal by EHA to eliminate the old exposure classification system entirely, the Panel agreed to accept Dr. Wong’s offer to allow them to reclassify all their long dead employees. This way, the CMA-coordinated vinyl manufacturers could go ahead and provide new exposure estimates at no risk.
Because the data could then be analyzed both with the old and the new exposure data, and the CMA-coordinated vinyl manufacturers would have the reassurance that they could decide whether to use the old or new exposure estimates after considering how the different methods would effect the results!
The VCRC agreed that Dr. Wong would run all of the dead people through his analysis using both the new exposure classifications and the old classifications, then, based on the results from the two sets of analysis, the employers could choose which classification scheme to use. So, the data would be preliminarily analyzed and the sponsors would be required to choose whether EHA should use the old or the new exposure classifications after they were able to determine which method gave them the most favorable results.
EHA committed to perform an analysis of their study’s statistical power. As the Beaumont & Breslow study had demonstrated in 1980, the cancers the CMA Group were dead set to eliminate as scientifically attributable to VINYL CHLORIDE exposure were precisely the ones that had been detected by all the epidemiologic studies to date with the statistical power to detect them.
1/17/84
Alex Munn of Monsanto told Bennett that Doll had expressed concern about writing a review of a cancer registry that isn’t even published. However, Munn maintained that, although the circulation was private, t all the people involved in the VCM/PVC scene did get a copy in the circulation.
However, Bennett (Hillhouse site manager in Blackpool) admitted that the registry would had received better universal recognition if it had been published in some format, and sought Doll’s advice on how this might be done.
However, in fact, however, with approximately with five exceptions, every named recipient of the registry appears to a company doctor or trade association employee, or management employee or some sort.
2/21/84
Doll made suggestions to Dr. Bennett at ICI about how to change the registry and suggested that because of the widespread interest in these data a brief article summarizing the results in a few tables would be greatly welcomed PARTICULARLY TO SHOW HOW few cases there have, in fact been.
11/8/84
On 11/8/84 Dr. Bryan Bennett (ICI) formerly requested Sir Richard Doll to review all the epidemiological database in order to provide a critical review of the VCM literature. The American VCM Industry agreed that they would be happy to fund such a project. The reason, the protocol, the cost were not discussed, nor was the content of the article, since the vinyl industry can only have had a very good idea knew of what the result would be through ICI’s Bennett, who had only recently co-authored a published article on the ICI Angiosarcoma registry).
11/8/84
On or about November 8, 1984, Dr. Brian Bennett, the Site Medical Advisor for ICI, Ltd. at ICI’s Hillhouse facility in Blackpool, England, wrote Dr. Carol Stack at the CMA that he had written to Sir Richard Doll, asking about the possibility of his reviewing all the epidemiological data base, in order to perform a critical review for industry.
Sir Richard Doll and Dr. Bennett were in the process of writing a paper for publication with reference to the ASL Register, helped by David Forman, who worked for Sir Richard Doll.
11/8/84
Dr. Bennett wrote Dr. Doll that, as a result of a meeting Bennett had with Dr. Johnson from BF Goodrich, Dr. Stack from CMA, and from speaking to Ted Torkelson at Dow, he had been asked if he could identify someone who could perform a critical review of the epidemiologic studies to date.
The American vinyl producers demonstrated that they would be honored if Bennett could recommend someone who might review all the epidemiological database in order to provide a critical review of the VCM literature.
11/26/84
On November 26, 1984, Dr. Stack wrote the Vinyl Panel members enclosing Dr. Bennett’s November 8, 1984 correspondence on behalf of ICI, Ltd.
Dr. Stack described meeting with Dr. Bennett and expressed enthusiasm for such a project, encouraging contact with Dr. Doll.
1985
Along with the angiosarcoma registry, the CMA-coordinated vinyl manufacturers were provided a copy of an article in the Journal of Toxicology and Environmental Health, by Andrew R. Moss, entitled “Occupational Exposure and Brain Tumors.”
The article concluded the only example of a proven central nervous system carcinogen was VINYL CHLORIDE.
1/2/85
On January 2, 1985 , Dr. Doll relayed David Forman’s question about what the sources of information were for the data in tables III and IV. Of the ICI ASL Registry paper.
1/30/85
Bennett wrote Dr. Doll back on 1/30/85 about what the sources of information were for the data in tables III and IV were. Doll was told that the ICI Commercial Intelligence Department originally collected the information, but that it was continually updated and verified by recipients of the registry since that time, giving J.T. Barr’s plant corrections as a recent example .
Doll asked whether they should add any acknowledgements with regard to the ASL Registry study. Bennett’s reply was that no acknowledgements were necessary.
1/31/85
Dr. Doll agreed to insert Dr. Bennett’s (ICI’s) alterations to BJIM paper and sent a cover letter for all the authors to sign (Stafford and Bennett). In the course of the letter, Dr. Doll said he was glad to hear that Bennett thought the figure for CMA’s donation to Green College in Oxford was appropriate Doll said he looked forward to hearing formally from the states about just what they want him to do about sponsoring the report.
5/85
In May of 1985, Dr. Doll wrote asking ICI, Ltd. (Bennett) whether the (unpublished) birth defect papers by Downs, et al and McMann could be referred to publicly or whether they were internal documents for their own information.
5/12/85
Dr. Bennett wrote Dr. Doll that the Americans as well as the PVC/VCM industries have all given their necessary confirmation for the “critical Review” Doll was to write for them. Bennett promised ICI and the Americans would be only to pleased to help supply Doll with any information he needed. Dr. Bennett went so far as to express the belief that Doll’s paper would be beneficial not only to the VCM industry in general, but “also to the world.”
5/30/85
Dr. Doll had sent a draft of the AOL paper on 1/2/85 (@97)
Just as would be the case two years later when Dr. Doll would publish his “Critical review” of the worlds literature at the (undisclosed) request of the CMA-coordinated vinyl manufacturers and others, Doll had requested what to do about acknowledgements; After consulting with John Stafford Dr. Bennet wrote Doll that they couldn’t think of anyone who should be acknowledged with regard to the angiosarcoma paper.
David Forman, who was assisting Dr. Doll in preparing the angiosarcoma paper, had asked about its Tables 3 and 4. Dr. Bennett’s answer was that the information on the angiosarcomas was initially produced by ICI Commercial Intelligence Department, but was continually being updated and verified by the recipients of the register.
Apparently as an example, Bennett noted that J.T. Barr from Air Products had sent Bennett “plant corrections,” which he placed in the most recent register.
11/8/85 [86]–new paste
On November 8, 1985, the VCRC, representing and in close communication with the Vinyl Panel, met with Dr. Otto Wong, Dr. Donald Wart and Dr. Donald Whorton of Environmental Health Associates at their offices in Berkley, California.
The purpose of the meeting was to receive EHA's phase 2 interim progress report.
They were told, as if they didn't already know, that, the manner previously described, the plants had been allowed totally uncontrolled discretion to alter exposure levels of cohort members living in debt. Consequently, 815 workers were reclassified by the plants as not having even having been exposed to vinyl chloride.
Consider that the members of the Vinyl Panel[xxv] that received copies of this report all knew that these 815 would remain in the study and, in fact, remain there even today.
The reason the vinyl industry is still able to use this report for their purposes even going through the motions of updating this irreparably biased cohort in the 1990s, is because the Group has been almost completely successful in concealing potential evidence of their misconduct like the report the VCRC received and disseminated to the entire Panel at this meeting unlike the events set forth in that report. 815 individuals were "reclassified" by the plants right out of the cohort.
As a result, the sponsors were allowed yet to take another whack at reclassifying them, perhaps with a little more subtly this time. The Group was allowed to reclassify the exposure assessments for dead employees. Fifty dead workers had already been reclassified as unexposed, thus retrospectively curing any cancer problem they might have with great expedience. However, 235 of the 707 deaths from the original study were hanging in limbo, defined both as exposed enough to be in the study and as not exposed enough to be in the study.
Absolutely none of these problems were ever resolved in any manner than by concealing them and every member of the Vinyl Panel participated in concealing them – not only the gross defects in the database the Panel would soon employ to split hairs about such precise and accurate sounding matters as statistical significance and the consistency of dose response curves, without so much as suggesting that the data was obviously more than just a little bit dubious.
The CMA Group was given very specific information about excluded plants that they never made public, even under circumstances where this information would have to have been revealed to prevent other statements and assertions they made about the studies they had sponsored and were, without a single exception consistent in concealing in every year since they hired Dr. Doll to wave his hands over the world's epidemiologic literature on vinyl chloride, blessing some, while excluding others for reasons the sponsors very well knew were false.
For example, Dr. Doll's decision that it was proper to discount all the American studies but the ones CMA and MCA sponsored were based on the incredible assumption that the study populations involved in the independent studies were subsumed by the larger and more complete CMA sponsored studies, and that all the workers involved in the independent studies were included in the MCA/CMA cohort and so, according to Dr. Doll, could safely be completely disregarded.
However, despite the fact that Dr. Doll's industry financed review of the literature is almost certainly the most common document found in the files relating to vinyl chloride health effects maintained by the CMA coordinated Group of vinyl manufacturers, and despite the Group's continual use of the Doll paper as propaganda in those companies' continuing efforts to minimize the extent of to which the carcinogenic hazard posed by vinyl chloride is perceived by the medical profession and, by the general public, and by those companies' own workers, none of the companies possessing direct knowledge that the assumption Dr. Doll used to sweep all the untidy independent, smaller studies that conflicted with the CMA's efforts to manufacture a false consensus that the carcinogenic risks associated with vinyl chloride have been grossly exaggerated and that, in fact, vinyl chloride is not responsible for causing any human cancer other than the extremely rare form of cancer known as angiosarcoma.
Under these circumstances, even without considering the other secret biases the CMA concealed from Dr. Doll as well as everyone else, the industry's concerted silence on this obviously false essential premise to Dr. Doll's industry finance conclusions amounted to fraud. In fact, the 1986 Wong report did not even include at least six plants that had been in the EHA study the last time the CMA had allowed anything from their studies to be submitted to the Government in 1978.
The MCA Panel was specifically informed that 551 individuals who were no longer actually unknowns at all, but who were the very precisely identified employees of companies that had seen fit to take all their workers out of the study or incomplete records.
The CMA Group was informed that, as if they didn't already know, that the entire reclassification procedure – apart from being almost evidence of misconduct on its face given the absence of any records justifying the reclassification effort – had additionally been intentionally biased by allowing workers to be defined out of the study when, ten years later (and in many cases even after they died) they were second guessed to have been improperly included the first time around and actually not exposed to vinyl chloride after all.
The Vinyl Panel all understood that the corrupt study design they had been following albeit with great difficulty, in some instances, had intentionally been a one-way street, allowing employers to take their dead employees (both living or dead) out of the study if they wanted to.
The sponsors knew that allowing workers that had supposedly been improperly included in the study to be taken out of the study while deliberately refusing to include the thousands of workers they knew had wrongfully been excluded from previous industry sponsored studies over the years, was not a simple mistake.
It was intentional misconduct that all of the members of the Panel concealed and have never publicly revealed.
The over 800 workers the member companies thought should have never been included in the study are still in the study; the thousands of workers improperly included in the study are still excluded; and the industry's paid scientific flacks are still misleading the public and the scientific community by pretending the MCA / CMA database, including its completely discredited exposure estimates and dose response curves, resulting wherefrom, are still being plied as the propaganda tools that they are truly are, and were always intended to be.
This might very well not be possible if information like that revealed to the Panel at this meeting in 1983 and in the evaluation of the underlying database they received in 1980 came to public knowledge.
For this reason, this continued concealment of the type of information reflected by this example must be concealed if the CMA's continued efforts to conduct fraudulent science are to continue, including, specifically the industry's continued political and public relations "use" of this very study, both in and of itself, and after being sanitized through a review paper published by Sir Richard Doll in 1987.
The CMA Group decided to require the contractor to analyze the data using both the original and reclassified exposure information even while openly recognizing that there was no evidence that the reclassification effort was anymore or less valid (or meaningless or, since there was no data to begin with anyway, pretty much meaningless) – the committee required EHA to analyze the mortality data on their workers using both the worthless and misleading exposure classification scheme originally employed and the worthless and misleading reclassification scheme the local plants had recently fabricated out of clear air so that they might use the data that most suited their financial interests, at least if they wanted to.
The Panel was specifically aware that the reclassification scheme that was implemented between 1980 and 1984 not only did not provide for wrongfully excluded workers to be included while allowing improperly included workers to remain in the study, the sponsors also knew that there was no documentation for the raw position that the new reclassification scheme was valid or, indeed anything other than a fraudulent tactic to substitute one meaningless set of data that, in the sponsor's estimation, was more consistent with their financial interests.
The CMA Group required EHA to abandon the high, medium and low exposure classification system they had previously employed, despite their own second thoughts about it, when they realized they could not "improve" their study by using them, or that they could achieve their illicit purposes without the risk of using the already pretty well discredited HML exposure stratification they had employed with some misleading effectiveness in years past.
The entire purported attempt to "confirm" the reclassified non-exposed status of the 815 cohort members that the sponsors had defined out of the cohort recognized by all senior personnel involved as cover-up activities that were necessary for the plants to undertake if their continued ability to conduct fraudulent scientific studies like this one was not to be impeded by the public revelation of their prior and ongoing fraudulent misconduct.
On information and belief, in order to demonstrate to the sponsors the power he had and would not hesitate to employ if the sponsors persisted in their disinclination to pay his group to conduct further studies after another major intentionally biased industry sponsored study (on benzene) had gone awry, accidentally proving disease and the CMA Group had, in a concurrent embarrassment that had put Dr. Wong "on the outs" with industry, until he flexed his muscle and published the EHA update almost ten years after the update had ended.
The API / CMA study had been grossly compromised (although this was covered up by the participants) when, as a result of the fact that a partner of Dr. Wong, (Dr. Morgan) had the nerve to testify in civil litigation that specific workers had developed cancer as a result of their exposure to benzene, which led to the Group's general retaliation against Dr. Wong's contingent and the withdrawal of an extremely large portion of the benzene cohort from the ongoing benzene study (Texaco's workers) on account of the audacity of Dr. Wong's associate in daring to express an opinion that an individual worker had actually contracted cancer as a result of benzene exposure.
All these circumstances led to rumors that spread to both sides of the ocean, including to Sir Richard Doll, to the effect that Dr. Wong had been "fired" as a result of the problematic benzene study that, despite having been grossly compromised when Texaco withdrew its cohort members from the study when one of Wong's associates testified in court that benzene had caused cancer, the study went on to find excess cancer anyway.
Although Dr. Wong had agreed to suppress his own benzene study, for some reason this was not considered possible by the sponsors and Dr. Wong had gone on to catch the blame for CMA ending up with one of their own studies showing excess cancers in benzene exposed workers, a result that had come about despite the best efforts of Dr. Wong and his sponsors and even despite Dr. Wong's own agreement to suppress the study completely which, for whatever reason, could not be done.