RightOnCanada.ca

February 4, 2013

To: Faculty and others McGill University

Over the past ten years, several researchers and I have written letters of complaint questioning the integrity of the ongoing McGill/McDonald studies on asbestos. Recently, Dr. Abraham Fuks submitted an investigation report regarding the McDonald studies to Dean David Eidelman.

To sum up our concerns briefly, the data used for the 1998 paper was so problematic that the authors actually wrote that “taken at face value” the results indicated that asbestos exposed workers had lower cancer rates than the general population. This was a nonsensical result since after the Selikoff conference in October 1964 no one disputed that asbestos was a lung carcinogen. The McGill researchers then deleted data points until the data showed that asbestos exposure was “innocuous.”[1]

This is not merely an academic debate. The asbestos industry and its consultants (including Dr. McDonald, who has testified for companies and in front of the World Trade Organization regarding the benign nature of asbestos) have used and continue to use the “innocuous” characterization and other similar comments belittling the toxicity of asbestos to promote the use of asbestos in developing countries. This remains a current problem. The McGill research has been misused to remake this same argument in a paper, Health risk of chrysotile revisited, which was financed by discredited chrysotile asbestos lobby organisations (the International Chrysotile Association and the Montreal Chrysotile Institute[2]) and published this month. (See attached). Dr. McDonald has, in fact, in the past, collaborated with the lead author of the paper (David Bernstein) and several of the co-authors in lobby efforts to persuade the World Health Organization[3] and the government of Brazil[4] to approve use of chrysotile asbestos.

Professor Fuks, Research Integrity Officer at McGill, produced a woefully inadequate response to our complaint that failed to consider most of our arguments. For example, he was unable to obtain any of the original data including the location or names of the mines that were studied. Dr. McDonald last published a paper based on this data in 2010. Certainly the underlying data must be maintained for at least three years particularly in view of the fact that one of us (DE) filed a complaint in 2002.

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We ask that you review our detailed response to Dr. Fuks’ report and request that the University invite independent researchers to conduct a review of our accusations. If Professor Fuks is correct then an independent review can only buttress his conclusions.

We have attached the following three key papers mentioned above:

· The Liddell, McDonald, and McDonald 1998 paper describing data manipulation in the appendix.

· McDonald’s latest (2010) paper, which repeats the problematic data.

· The most recent use of McDonald’s conclusion that asbestos is “innocuous.”

Sincerely,

Dr. David Egilman*, Clinical Professor Department of Family Medicine, Brown University; Editor International Journal of Occupational & Environmental Health

Prof. Fernand Turcotte, Professor Emeritus of Public Health & Preventive Medicine

Kathleen Ruff, Senior Human Rights Adviser, Rideau Institute; Founder, RightOnCanada.ca

*Dr. Egilman has testified in asbestos litigation at the request of both asbestos manufacturing companies and workers who have died as a result of asbestos exposure.

[1] “Years in the highest relevant dust category were pooled with those in the adjacent category and the analysis was repeated. This process was iterated until either all coefficients had become positive, when it was terminated, or until the only negative coefficient was for category 1; in that circumstance category 1 was eliminated from the model, which was equivalent to setting the coefficient to zero and the odds ratio to unity. Admittedly, there was a degree of arbitrariness in some of the pooling carried out but every effort was made to retain any ‘significant’ effects.” [Emphasis added] Liddell FD, McDonald AD, McDonald JC. Dust exposure and lung cancer in Quebec chrysotile miners and millers. Ann Occup Hyg. 1998 Jan;42(1):7-20

[2] “It is our view as Canadian experts in epidemiology and occupational medicine and as public health advocates that the Chrysotile Institute is endangering public health by disseminating misleading and untruthful information about chrysotile asbestos, especially in the world’s emerging economies.” Letter of January 23, 2009 to Prime Minister Harper from Dr. Fernand Turcotte, Dr. Pierre Auger et al.

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[3] Letter to Margaret Chan, Director General, World Health Organization, February 27, 2007

[4] Presentation, Parliamentary Commission on Banning Asbestos, Brazil Chamber of Deputies, September 29, 1999

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Detailed Response to Professor Fuks’ Consultation Report to Dean David Eidelman

Concerning McGill Asbestos Research

This article addresses a recent investigation into the research integrity of a series of studies out of McGill University undertaken by Professor Abraham Fuks, Research Integrity Officer at McGill University.

We believe it is vital that an informed public understand what is at stake in Prof. Fuks’ “Consultation Report to Dean David Eidelman” of the McGill Faculty of Medicine. Our objections to the report, and to the research addressed in the report, are based on a concern for public health in developing countries where the McGill research is used to support the industry’s claim that exposure to asbestos is innocuous.

Prof. Fuks “investigation” failed to address the key allegations of research impropriety, and repeated false statements that disavowed the corporate funding of the research in question.

Over the past ten years, one of us (Dr. Egilman) signed two complaints addressed to McGill University that accuse some University faculty of manipulating research data to conclude that exposure to chrysotile is innocuous (not harmful or injurious.) The first complaint was filed in 2002, at which time Prof. Fuks was the Dean of the Medical school.i The issues of concern were laid out in a peer-reviewed paper, which provided a detailed critique of the McDonald studies in 2003.ii That publication serves as the factual basis for my call for an investigation and retraction of the McGill asbestos research papers, which were directed by Dr. J.C. McDonald. McGill failed to initiate any investigation of that complaint. The second complaint was sent to Drs. Eidelman and Fuhrer in February 11, 2012. McGill received further complaints, which were jointly signed by other researchers and experts, on February 2, 2012 and February 10, 2012.

These complaints were forwarded to Prof. Fuks, who now serves as McGill’s Research Integrity Officer.

Prof. Fuks filed a report of his investigation of the McDonald studies in September 2012.iii

Dr. Egilman’s Original Concerns (emailed February 11, 2012)

In the letter of complaint to Drs. Fuhrer and Eidelman, Dr. Egilman asked about three areas of concern:

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1. Data manipulation

“Question 1. The first question for you is: Did McGill researchers manipulate the study data and did the manipulated results show that Canadian asbestos only caused cancer after massive exposures?”

The McGill researchers described how they manipulated data in their 1998 paper, in which they described how they intentionally dropped data points to achieve the result they desired – the description of asbestos as “innocuous.”1

In his recent report, Prof. Fuks fails to address this allegation except to note that the study data has disappeared.

2. What was the location of the “high and low tremolite mines”?

This data was deemed “essential” to assure the veracity of the McGill research. Prof. Fuks report fails to determine the location of the mines. Without this crucial information, the McGill research lacks scientific foundation and must be rejected.

3. Where is the Sebastien data that shows there were low and high tremolite levels in “Central and Peripheral” mines?

Prof. Fuks repeats Dr. McDonald’s published misinformation giving the impression that Dr. Sebastien produced the data in a published paper. There is no such data in any published paper. Dr. McDonald claimed Dr. Sebastien provided a distinction between the central and peripheral mines. Dr. Sebastien says he never performed such a study.iv

Prof. Fuks has failed to find the data that the McGill researchers claim existed and that formed the basis of their conclusion that asbestos exposure is innocuous. The study must be retracted.

Allegations Addressed in Prof. Fuks’ Consultation Report

We will now respond to Prof. Fuks response to the allegations in his September 2012 report. He created allegations based on “all those cited” and “no distinctions are made amongst allegations noted in Dr. Egilman’s publications, his letters to the University, those in letters and emails from Kathleen Ruff and her co-signatories, and those cited in the mainstream media.” (p.4)

[1] “Years in the highest relevant dust category were pooled with those in the adjacent category and the analysis was repeated. This process was iterated until either all coefficients had become positive, when it was terminated, or until the only negative coefficient was for category 1; in that circumstance category 1 was eliminated from the model, which was equivalent to setting the coefficient to zero and the odds ratio to unity. Admittedly, there was a degree of arbitrariness in some of the pooling carried out but every effort was made to retain any ‘significant’ effects.” [Emphasis added] Liddell FD, McDonald AD, McDonald JC. Dust exposure and lung cancer in Quebec chrysotile miners and millers. Ann Occup Hyg. 1998 Jan;42(1):7-20.

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ALLEGATIONS 1 & 2

“The allegations claim that the original studies were ‘initiated between Prof McDonald and the asbestos industry’ and carried out at the behest of the industry whose goal was to control the research agenda and the resultant data. It is further claimed that JCM’s published comments that the Government of Canada was involved at the outset of the studies are misrepresentations.” (p.4) …

“The allegations claim that JCM gave ‘false information’ and denied ‘connection with any asbestos company” (p.6).

Prof. Fuks’ Findings:

“While I can well appreciate the stance that one must view the motives of the asbestos industry with suspicion, I can find no evidence to support the allegation of misrepresentation on the part of JCM regarding the origins of his research project on asbestos” [emphasis added] (p.4)

Response:

First, Prof. Fuks admits that there was a funding connection between Dr. McDonald’s research and Q.A.M.A.: “Dr. McDonald’s proposal was presented to Q.A.M.A. in 1965 and Q.A.M.A. subsequently provided a research grant to McGill University for three years” (p.5). The complaints to Prof. Fuks included a letter dated Nov. 27, 1964, that Dr. McDonald, on his own behalf and initiative, wrote to Johns Manville soliciting their support for him to carry out the research project on the miners. He was also provided with Dr. McDonald’s 1997 paper in which Dr. McDonald contradicted this fact by stating that, “We began our work in 1966 at the request of the Canadian Government.”v In 1965, Dr. McDonald was invited to become a member of the National Study Group on Asbestos of the Canadian Department of National Health and Welfare, Prof. Fuks does not document any government funds to McDonald in the 1960s, noting that in Dr. McDonald’s meeting with government agencies “funding was not discussed” (p.5). In fact, it wasn’t until 1981 that anyone in McDonald’s group reported, in a published paper, any government funding. The United States Government (NIH) funded part of the McGill research for this 1981 paper, which was on magnetic lung measurements in relation to occupational exposure to asbestos.vi (See Appendix 1)

Q.A.M.A. minutes of the November 29, 1966 meeting, at which the leading asbestos industry executives approved Dr. McDonald’s research proposal, show that a condition for their support was that the asbestos industry should maintain control over the research and that it should not “fall in the hands of the Government”.2

[2] “A first and unanimous recommendation was the carrying out of the epidemiological survey proposed by Dr. McDonald. The consensus of opinion seemed to point out that the Q.A.M.A. should take into its hands the ways and means to conduct the necessary research instead of doing it through universities or letting it fall in the hands of the Government. As an example, it was recalled that the tobacco industry launched its own program and it now knows where it stands. Industry is always well advised to look after its own problems.” Q.A.M.A. minutes, November 29, 1966.

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Dr. McDonald testified at the OSHA hearing on asbestos in 1973 that he had not received any company funding, “The first point is that I am a full time employee at McGill University, and an independent research worker. I do not work, nor am I associated with, any asbestos producer or manufacturer.”3vii [Emphasis added] Paul Brodeur attended the hearing and was allowed to confront Dr. McDonald on this point.

As a layman, I had little way of judging the scientific validity of Dr. McDonald’s work except through the observations of those members of the independent medical community who had communicated their opinions of it to me. However, I had brought with me to the hearings a copy of Volume XXII of the Archives of Environmental Health, containing Dr. McDonald’s article on mortality among the chrysotile-asbestos miners and millers of Quebec, which had been sent to me some months earlier by William P. Raines, a vice-president and director of public affairs for Johns-Manville. Since Dr. McDonald had referred to this mortality study during the course of his testimony, and since anyone attending the public hearings had the right to cross examine witnesses, including members of the press, I decided to ask him some questions about it. After receiving permission from Goldberg to address Dr. McDonald, I reminded him that in his opening remarks he had declared that all his research had been performed independently.

“That is correct,” Dr. McDonald replied. “All things are relative.”

I then reminded Dr. McDonald that John Jobe had testified at the morning session that his company was supporting research on asbestos disease, and asked him if that was research other than what he had performed. “I guess what Mr. Jobe is referring to is the fact that Johns-Manville, together with other mining companies, helps support the Institute of Occupational and Environmental Health, which is a granting body that receives research applications, and which therefore indirectly supports our research,”Dr. McDonald replied. “Now, it is a very indirect relationship.”

I then pointed out to Dr. McDonald that at the end of his article in the Archives of Environmental Health, a credit was listed in small type: “This work was undertaken with the assistance of a grant from the Institute of Occupational and Environmental Health of the Quebec Asbestos Mining Association.”

“That is correct,” Dr. McDonald said. (p.133-134)viii

[3] Brodeur wrote: “Dr. McDonald, who stated at the outset that he was a professor of epidemiology and the chairman of the Department of Epidemiology and Health of McGill University, and that he had specialized in epidemiology for twenty-four years. ‘I would now like to add one or two points not in my written submission, in order to clarify my position here,’ Dr. McDonald continued. ‘The first point is that I am a fulltime employee at McGill University, and an independent research worker. I do not work, nor am I associated, with any asbestos producer or manufacturer. The research I shall be describing is supported by grants, not to me but to McGill University, from a number of sources-the Institute of Occupational and Environmental Health, the Canadian government, the British Medical Research Council, and the United States Public Health Service. I am not here to support the testimony or position of Johns-Manville or any other body affected by the proposed regulations.’” Pages 119-120, Expendable Americans Brodeur, P. (1974). Viking Adult: New York. (See the chapter titled “Conflicts of Interest”)

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Prof. Fuks claims that Dr. McDonald did not misrepresent his funding source when, after confronted by Brodeur, he changed his testimony and claimed his Q.A.M.A. funding was “indirect,” despite the fact that his papers stated that “This investigation was supported by a grant from the Institute of Occupational and Environmental Health of the Quebec Asbestos Mining Association.”ix

Dr. McDonald disclosed that his funding came directly from the industry in the acknowledgments section of many of his early papers. As late as 1980, a McDonald paper carried the following acknowledgement: “Grants toward the cost of the research were made to McGill University and to the London School of Hygiene and Tropical Medicine by the Institute of Occupational and Environmental Health of the Quebec Asbestos Mining Association.”x We have evaluated 36 published papers that were published as a result of the initial Q.A.M.A. funding. Fourteen acknowledged direct Q.A.M.A. funding. The last paper acknowledging Q.A.M.A. money was published in 1986. Fourteen papers did not mention any funding source and seven acknowledge government funding. (See appendix 1 for list of papers).

Despite these acknowledgments Prof. Fuks defends Dr. McDonald and states that Dr. McDonald correctly represented the funding as “indirect.” No fair reading of this language would conclude that this was anything but direct funding. For example, Dr. McDonald testified as follows under oath in an asbestos lawsuit in 1984:

“Q. Have you received funds to support your research from an organization called the Quebec Asbestos Mining Association?

A. Yes

Q. Or a subsidiary of that?

 A. Yes

Q. That is an organization of asbestos companies?

A. Yes

Q. Who mine chrysotile in Canada?

A. Correct

Q. And you have also received funds from the Canadian Government?

A. Yes

Q. Anybody else

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A. From the United States Public Health Service; from the British Medical Research Council.” xi

Prof. Fuks’ Findings:

“There is no evidence that the design of the research, its conduct, and its reporting was influenced by the industry” [Emphasis added] (p.7-8). There is no evidence (nor was it alleged), that JCM was employed by or consulted to the asbestos industry.” (p. 7)

Response:

It is true that no one alleged JCM was employed by or consulted for the asbestos industry. However, contrary to Prof. Fuks assertion, “JCM was employed by and consulted for asbestos companies.” By 1986 Dr. McDonald served as an expert witness in litigation on behalf of many asbestos companies, including companies who had funded his research (WR Grace, Raymark, Carey Canada, and Turner & Newell (Bell Mines)) on at least seven occasions. Those benefiting from his testimony included: U.S. Gypsum, WR  Grace, Carey Canada, John Crane, Anchor Packing Company, Crane Packing Company, Eagle-Picher Industries, Owens-Corning Fiberglas, M.H. Detrick, GAF Bldg. Materials, Raymark Industries, Inc., Turner & Newell, and the companies of the Center for Claims Resolution in Madison County (including: Amchem Products, Inc., A.P. Green Ind., Inc., Armstrong World Industries, Inc., Certainteed Corp., CE Thurston & Sons, Dana Corp., Ferodo America, Inc., Flexitallic, Inc., I.U. North America, Inc., Maremont Corp., Nat. Gypsum Co., Nat. Ser. Ind., Inc., NOSROC Corp., Pfizer, Inc., Quigley Co., Inc., Shook & Fletcher Insulation Co., T & N PLC, and Union Carbide Chemicals and Plastics Corp.). xii Prof. Fuks fails to mention this consulting although he spoke directly to Dr. McDonald and gratuitously add his comments on the lack of consulting relationship between Dr. McDonald and asbestos companies.

McDonald did in fact serve as a paid consultant in litigation on behalf of asbestos companies against thousands of workers since some of these cases were mass torts.

Q.A.M.A. minutes summarizing their funding list Dr. McDonald’s funding source as Q.A.M.A. IOEH, a singular entity.xiii

Documentation submitted to Prof. Fuks showed clearly that asbestos industry executives constituted the board of directors of the Q.A.M.A. IOEH [4] that the companies maintained control over the work of the Q.A.M.A. IOEH and specifically created the Q.A.M.A. IOEH in order for the industry to control and shape research on asbestos health effects.

[4] A letter of March 30, 2012 from Kathleen Ruff to Dean Eidelman (and provided to Prof. Fuks) documented that the board members of the Institute of Occupational and Environmental Health of the Quebec Asbestos Mining Association were leading asbestos industrialists: Board members of the Institute of Occupational and Environmental Health included: Karl V. Lindell, Chairman (Chairman of the Board; Canadian Johns-Manville Co., Limited); Michael J. Messel, Member (President, Lake Asbestos of Quebec, Limited); W.W. Oughtred, Member (Executive Vice-President, Asbestos Corporation Limited); Parker Smith, Member (Vice-President, Bell Asbestos Mines Limited).

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Q.A.M.A. minutes of December 1965 state that the Q.A.M.A.’s motivation in creating the IOEH was to promote the industry’s interests:

The objective behind all this activity by the Q.A.M.A. is, of course, their desire to preserve the industry on which their business depends. Mr. Lindell assured me that they were most anxious to avoid any undesirable publicity or any precipitate action by the U.S.A. or Canadian Federal Government which might be detrimental to the industry.xiv

ALLEGATION 3: Chrysotile and its risks

“The allegations are that JCM ‘promote[d] the use of chrysotile asbestos’(35) and that he stated that his research ‘showed that asbestos was not harmful.’(36) Dr. Egilman’s article alleges that JCM ‘put forth several myths’ (37) and that JCM and his colleagues ‘manipulated data’” (p. 8).

Prof. Fuks’ Findings:

“…there has never been an allegation of data manipulation or falsification, nor any findings to indicate such misconduct (disputes regarding methodology are discussed below)” (p. 10).

Response:

Prof. Fuks did not address accusation of data manipulation at all.

However, there is evidence of data manipulation. In the appendix to their final paper on lung cancer and asbestos Liddell and the McDonalds wrote a section titled: “Elimination of negative regression coefficients.”xv

“In all the conditional regression analyses of the full model, i.e. with 13 exposure measures there was at least one negative regression coefficient, which taken at face value would imply a protective effect of exposure.” [5] [Emphasis added]

[5] The appendix to this paper is the only place where the McGill researchers describe their analysis methodology. This was a post hoc manipulation, which was not described in any study protocol or published paper. In objective science, the protocol for data analysis is written before the study begins and is never modified to achieve a particular result.

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The McGill researchers then explain how they manipulated the data to achieve the result they sought before the study was initiated:

“Years in the highest relevant dust category were pooled with those in the adjacent category and the analysis was repeated. This process was iterated until either all coefficients had become positive, when it was terminated, or until the only negative coefficient was for category 1; in that circumstance category 1 was eliminated from the model, which was equivalent to setting the coefficient to zero and the odds ratio to unity. Admittedly, there was a degree of arbitrariness in some of the pooling carried out but every effort was made to retain any ‘significant’ effects.” [Emphasis added]

In other words, the un-manipulated data or “the taken at face value” showed that asbestos exposure was inversely related to lung cancer risk and this relationship followed a consistent dose-response pattern. The data showed that the higher the exposure to asbestos the lower the risk of contracting lung cancer. This result conflicts with common sense and every other paper published about the relationship of asbestos to lung cancer.6 This result occurred due to a combination of errors:

· The midget impinger (MI) (the device used to test for exposure to all dust) results could not be converted into fiber counts. Dr. McDonald knew this before the study was initiated and he reconfirmed this problem in published papers and oral testimony. (See Allegation 4)

· The MI total dust counts were inversely related to asbestos fiber counts. The highest MI results occurred in the mines where less than 5% of the dust was asbestos and the lowest counts occurred in the mills where almost all the dust was asbestos.

The McGill team recognized that publication of the real results would reveal that their study found a nonsensical result. They thus deleted data points that contributed to the nonsensical results until they arrived at an outcome that appeared to make sense.

Further, there was not “a degree of arbitrariness.” An arbitrary approach would have dealt with the data without considering the impact data manipulation might have on the results. In contrast, the McGill researchers manipulated data based on the impact the data point had on the result. If a data point supported their a priori view that asbestos caused lung cancer in massive exposures they retained the data point. If the data point

caused the result to indicate that asbestos exposure protected against cancer or reduced the dose-response relationship they eliminated that data point. This data manipulation was done to achieve a pre-determined result.

[6] A possible exception is the Q.A.M.A.-funded Braun Truan paper on Canadian miners, in which the published version stated no increase in cancer in asbestos miners. However, original, unpublished conclusions found a statistically significant increase in lung cancer as a result of asbestos exposure. The McGill studies were the second set of corrupt investigations funded by Q.A.M.A. Egilman, D., Reinert, A., Letter to the Editor: Corruption of Previously Published Asbestos Medical Literature: The 1958 Q.A.M.A. Miner Cancer Study, Archives Env. Health, Vol 55, No. 1, Jan/Feb 2000.

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ALLEGATION 4:

“In his article of 2003 (52), Dr. Egilman presents an extensive analysis to support his claim that the methods used to assess asbestos exposure were flawed, thus supposedly undermining the entire cohort study and its conclusions” (p.10).

Prof. Fuks’ Findings 1

“…Although the new method was available when the study began, collecting prior exposure data using the new method was not possible. Furthermore, abandoning the old method when the study began ran the risk of making impossible the calculation of cumulative exposures over many decades, something clearly crucial to assessing carcinogenic risks. Finally, there is no documentation or evidence presented to support the claim that the ‘research methods were fatally flawed’” (p.11).

Response:

Prof. Fuks largely agrees with my analysis of the inadequacies of midget impinger. However, he concludes that the research methods were not “fatally flawed’” (p.11). As explained above, the use of the midget impinger prevented McDonald from assessing or calculating the cumulative exposure over many decades, which Prof. Fuks notes was “something clearly crucial to assessing carcinogenic risks” (p.11).

The best evidence of fatally flawed methods is the manipulated data described above. The inadequacy of the midget impinger method is the reason the results “taken at face value” produced a nonsensical conclusion: asbestos prevented lung cancer. The use of the midget impinger is thus one of the main reasons that the methods are fatally flawed.

First, Dr. McDonald was told that the midget impinger could not be used for epidemiologic purposes to assess cumulative risk or standards before the study was initiated. During a large 1969 conference on dust diseases held in South Africa, where the question and answer sessions were published, McDonald asked, “Can an inaccurate instrument like the midget impinger give an accurate result?” Dr. Rendall answered him, “the midget impinger is the wrong instrument on which to base standards.”xvi [Emphasis added]

In addition, researchers confirmed the fact that the midget impinger gave the wrong results on several occasions. In a 1974 published paper that was part of McDonald’s studies, Gibbs and Lachance assessed the relationship between their MI rust counting results and actual measurements of asbestos dust.xvii They concluded, “However, these correlations suggest that for all mines the regression lines are unsatisfactory for the prediction of fiber counts from impinger counts, as the improvement in prediction for the best correlation (0.45) is only 13% better than a conversion obtained at random.”

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McGill researchers reconfirmed the inadequacy of the midget impinger method: “There is no rule-of-thumb conversion from dust to fibre counts. Therefore, all measurements ever made in the industry using midget impingers (10,205 particle counts between 1945 and 1976) or membrane” filters (11,819 counts of fibres greater than 5 μm in length between 1969 and 1976) were compiled. For each job in which any of the 2217 subjects had worked, a fibre/dust ratio – ranging from 0.3 to 30 (fibres per ml)/mppcf – was assessed;…”xviii In other words the there was no correlation between particle counts and fiber counts. A particle count of 1 million particles per cubic foot could not distinguish between .3 fibers/cc and 30 fibers/cc, a 100-fold range.

At the 1982 Royal Commission on Matters of Health and Safety Arising from the Use of Asbestos in Ontario, Dr. McDonald considered that his group’s attempt to convert particles to fiber measurements was “more or less fizzling out, actually. I mean, we’re beginning to get depressed about it. (Laughter.) We’ve been doing it for a good five or six years, and I think we know how almost unanswerable the problem is.”xix

Prof. Fuks’ Findings 2

Prof. Fuks quotes Dr. McDonald: “The impinger method used is not wholly satisfactory but at least there is an objective and reasonably standardized comparison of available dust conditions in a considerable variety of locations in all the companies” (p.11). Another method was available, the membrane filter method, but, as Prof. Fuks notes, Gibb and Lachance “cautioned against using the membrane filter method to set safe exposure levels, simply because the epidemiologic risk factors had been analyzed using the

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old method and the conversion factors were not precise enough to set appropriate occupational risk guidelines” (p.11). Prof. Fuks goes on to conclude that “in those instances where JCM compared his data to other groups who had used the more recently available method, he was careful to state his assessments in guarded terms” [emphasis added] (p.11).

Response:

Dr. McDonald did not state his findings in “guarded terms.” Instead he overstated his findings and characterized them as showing that asbestos exposure was “innocuous” (defined as exposures that would not occur during normal use of asbestos) based on the false conclusion that only high exposures would cause disease.

Contrary to Prof. Fuks’ assertion, Dr. McDonald was the opposite of “careful” or “cautious” regarding the findings of his research. Throughout the decades, Dr. McDonald dogmatically and categorically claimed that his research showed that chrysotile asbestos was “virtually innocuous,” except at extremely high levels of exposure. This was, of course, exactly the message that the asbestos industry wanted given.

Dr. McDonald categorically, not guardedly, told the Tribunal that would be making a binding, legal decision for the WTO, that ´at levels below about 25 fibres per c.c. for forty years’ work, we could not detect an increase in lung cancer” and that therefore “exposures at modern levels of say one fibre per c.c. wouldn’t possibly be detectable.” Dr. McDonald ignored his own results and his own written and oral confirmation of the fact that the dose measurements were useless and could not be used to estimate cumulative exposure or assess risk. Basing his conclusion on the MI data, McDonald “concluded from the viewpoint of mortality that exposure in this industry to less than 300 mpcf.y has been essentially innocuous, although there was a small risk or pneumoconiosis or mesothelioma” [emphasis added] (p.9-10). In essence, Dr. McDonald claims that 300 mppcf is higher than any worker or consumer would be exposed to asbestos. xx

Prof. Fuks later states: “In fact, JCM noted an excess of lung cancers in asbestos workers in the earliest papers and reports and this could not have been a happy outcome for the asbestos companies” (p.14).

The defense of chrysotile is based on the argument that exposures (doses) that usually occur when asbestos is used are innocuous. The asbestos industry used his innocuous characterization to oppose the EU ban on asbestos imports and to market asbestos in developing countries.[7] xxi

[7] “According to four specialists, chrysotile fiber can be eliminated by the body… According to recent conclusions by four foreign researchers, the controlled use of chrysotile-type asbestos in Brazilian industries is not hazardous to the health of the workers…According to Professor McDonald, research carried out in Canada on workers exposed to chrysotile which was contaminated by amphi[bious] fibers showed satisfactory results according to occupational health standards. The Canadian workers were  exposed to 100 fibers per cubic centimeter.” (Galvao and Coelho, O Estado de Sao Paulo (Newspaper) July 1, 1999, page A16)

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Dr. McDonald’s unreserved claim, in scientific publications,[8] in presentations to political bodies, in testimony before a World Trade Organization Tribunal, and in media articles, that chrysotile asbestos could be “safely used” and was only harmful at extreme, prolonged exposure levels, was extremely pleasing to the asbestos companies, as it exactly mirrored their marketing message.

Prof. Fuks justifies McDonald’s conclusions despite the fact that his characterization of chrysotile asbestos as innocuous is based on a method of data collection that everyone, (Dr. McDonald. Gibbs, Lachance, Randall and indeed Prof. Fuks himself) agrees was faulty.

Prof. Fuks concludes: “Given that JCM and colleagues were studying the occupational exposure of a birth cohort that entered the work force long before the study began, they did not have the opportunity to carry out prospective measures of exposure and were forced to either use the data available or not initiate the study” (p.11). Prof. Fuks rebuts this argument two sentences later: “Although the new method was available when the study began, collecting prior exposure data using the new method was not possible”

The study could have been done with fiber measurements and this could have provided reliable fiber measurements for a 32-year period since the study began in 1965 and terminated in 1998.9 This would have eliminated the “unanswerable” problem of particle to fiber conversion. Prof. Fuks argues that knowingly using a “wrong measurement” device which resulted in wrong results (asbestos prevents lung cancer) was correct. This is akin to using a scale that gives a random result that is between 3 and 300 pounds for each weigh-in to evaluate the efficacy of a diet. Prof. Fuks’ conclusion is nonsense.

[8] As one example: “There is abundant epidemiological evidence that chrysotile, even when contaminated with fibrous tremolite – the main culprit – can, with effective dust control, be mined and used safely for the production of cement and friction products (…) We have most of the essential facts and, if anything, we should surely be encouraging the search for and exploitation of chrysotile which – free from amphiboles – is a remarkably safe and valuable natural resource.” J. Corbett McDonald MD, FRCP. (2000). Letter to the Editor “RE: Call for an international ban on asbestos: Why not ban asbestos?” American Journal of Industrial Medicine, 37(2):235.

[9] More importantly, from a public health perspective, Dr. McDonald failed to tell the mines that they should use the new methodology to protect the workers.

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Finally, Prof. Fuks states: “Indeed, the results of the research and its conclusions have been replicated many times by other groups and reviewed by many generations of competent peer reviewers” (p.11). Prof. Fuks fails to cite any studies that have replicated Dr. McDonald’s conclusion that exposure to asbestos is innocuous or his finding  that asbestos protects against lung cancer. Studies of South Carolina textile workers who were exposed to Canadian Chrysotile shipped from Thetford found a lung cancer risk that was 10 fold higher than the risk Dr. McDonald reported post data manipulation.xxii McDonald himself recognized that his data was not consistent with NIOSH’s textile results, “At the time of publication of these various studies it was immediately clear that the slope of the exposure response lines for lung cancer in the textile industry was some 50 times steeper than that observed in Quebec chrysotile miners and millers where exposures were very much higher and for whom an equation of RR = I +0.016mpcfy for lung cancer risk had been estimated (McDonald et al., 1980)”xxiii McDonald also reported that mesothelioma risks were fifty fold higher in South Carolina textile workers that in his miner studies.xxiv

Please see the conclusion for a discussion on peer-review.

ALLEGATION 5: Identification of Mines

“Dr. Egilman, in his analysis of an article in Science by JCM and Allison McDonald (57), noted that the suggestion that tremolite, a form of asbestos, may be responsible for the carcinogenic properties leading to mesothelioma, depends on the distinction between ‘central and peripheral’ mines described in that article” (p.11).

Prof. Fuks’ Findings:

“I cannot find direct identification of which specific mines were in areas A and B and all the published data are coded both for subjects and mine. It is therefore not possible to make these linkages by name. However, that per se is no basis to presume that the analyses that JCM and his colleagues performed are flawed. All the numbers track clearly from paper to paper over a span of many years and each case included or not included in a given analysis is accounted for and explained clearly. The findings are consistent with those of others in the research community, including those who may have been characterized as competitors or critics of the McGill group” (p.13).

Response:

The most important piece of missing information is the location of the “Central and peripheral mines.” In response to my 2001 complaint to Science regarding this issue, the journal wrote:

“Dr. McDonald confirmed that the specific mines and the mine locations in areas “A” and “B”, as designated in the 1995 Letter to the Editor in Science have never been published, and he indicated that such information was routinely not included in order to protect plant/plant owners. It would only be included if essential, and in the case in question, it was deemed essential. We are still considering this situation.” [Emphasis added]xxv

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Thus contrary to Prof. Fuks’ conclusion, Dr. McDonald failed to report this “essential’” information to “protect/plant owners.” In fact the names of the mines had already been disclosed in Dr. Gibbs 1972 Ph.D. thesis. However, neither this thesis nor any other paper disclosed the location or names of the “central” or “peripheral mines.”

Science took no further action, explaining to me that they had no “legal authority” to deal with allegations of fabrication of data and that the institutions where the researchers work are responsible for investigation.xxvi10

Prof. Fuks claims that, “In order to suggest factors to account for this difference, he [Dr. McDonald] referred to published work from his colleagues who had observed higher concentrations of tremolite fibers in the lungs of miners who had worked in area A mines compared with those in area” (p.12). Prof. Fuks is correct that Dr. McDonald referred to “published work” but the “published work” he referred to did not contain any such data. Prof. Fuks fails to cite any “published work” that compared tremolite levels between central and peripheral miners. Dr. McDonald claimed Dr. Sebastien conducted such an analysis but Dr. Sebastien denied that he conducted any such study in an email to my staff.xxvii Prof. Fuks statement is an intentional misrepresentation intended to give the misimpression that data comparing lung tremolite levels between “central and peripheral” miners exists. It does not exist and Prof. Fuks is aware of that fact.

Prof. Fuks is also aware of the fact that he (and presumably Dr. McDonald who he consulted) cannot determine how many or which mines were studied. He cites me for the proposition that 15 mines were studied but he conducted his own investigation and could only find 12 mine companies.

The map of the asbestos mining areas of southern Quebec depicts a grouping of four mines near the centre of Thetford Mines (labeled King Mine, Bell Asbestos Mines, Johnson’s Asbestos Co, and Beaver Mine) and eight others further removed from the centre. Whether these are the mines in area A and B cannot be determined at this point. Nonetheless, the map also depicts geological heterogeneity amongst these sites. (p.12-13)

Prof. Fuks conflates mines and mine companies.

[10] McGill responded to my complaint regarding the Science letter, stating that: “Some of the data on which the Science Letter was based was not part of the research conducted by Dr. Sebastien and Dr. Corbett McDonald in 1989, and contrary to what your letter suggests Dr. McDonald never argued that his results were solely based on Dr. Sebastien’s data. The fact that Dr. Sebastien responded to you that ‘this point was not addressed in my ’89 paper’, does not mean that the data does not exist. It means that Dr. Sebastien’s study… had not looked into the issue of geographical distribution of mesothelioma deaths and the distribution of tremolite contamination.” They directed me towards McDonald and McDonald’s 1997 paper where the “results were later confirmed… with a more detailed discussion of geological issues.” This paper does not include any information correlating lung tremolite levels and mine location nor does it identify the geographic location of central (“high tremolite”) and peripheral (“low tremolite”) mines. (Proulx, Louise letter to D. Egilman, January 19, 2004).

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Prof. Fuks concludes that he “can find no basis for questioning the analyses published by JCM and colleagues on the risk of work exposures in different mines, despite the difficulty in assigning specific names to the different mines in question” (p.13).

Prof. Fuks is unaware the fact that there is another difference that can explain the cancer rates in the “central and peripheral” areas. Indeed the McGill researchers never mention this competing explanation for the alleged central-peripheral difference in mesothelioma rates. At least three of the “central mines” were underground.xxviii Underground mining involved much higher exposures than above ground or mill exposures. For example in 1972, Gibbs and Lachance described these exposures, “Ore in underground mines is mined by the block-caving method. Drilling at the “Grizzleys” is performed dry, as attempts to use water in order to suppress dust resulted in hazardous conditions for workers. In underground development work, water is now used to reduce dust levels, but before 1950 even this was performed dry and with poor ventilation.xxix This fact alone could explain the different cancer rates in the two groups. Tremolite found in the central miners might be a result of the fact that the central miners had higher total asbestos exposures and tremolite is merely a marker for this.

Moreover, if the McGill researchers are correct then the peripheral mines produce a “safer” low tremolite product. This has important public health implications. Mining should have been restricted to these “safer” mines.

Finally, Dr. Fuks finds that McDonald’s findings are “consistent with those of others in the research community” (p.13). In 2000, Dr. McDonald testified before a World Trade Organization (WTO) tribunal, as part of the Canadian government’s delegation that was arguing that counties should not have the right to ban chrysotile asbestos as  chrysotile asbestos can be “safely used” and that a ban would constitute an illegal trade barrier. Dr. McDonald dismissed a study of Charleston, U.S. textile workers that showed far higher levels of harm being caused by Quebec chrysotile asbestos than his findings showed (see Appendix 2).

Dr. McDonald (Canada): Therefore, those of us who have been trying to understand why the textiles are different conclude, I think, that there is something funny about textiles… [In Quebec] we have one of the most complete pictures of mortality in chrysotile workers almost … than you can imagine. There is nothing comparable […] So we are left with the fact that Charleston is an anomaly. (Paragraph 150) (See Appendix 2 for full quote)

Dr. McDonald was aware that the study he dismissed had used far superior measuring techniques than the midget impinger, which Dr. McDonald knew was an unreliable technique.

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The independent panel of experts of the WTO, questioned McDonald’s data, because it was inconsistent and questioned the merit of relying on it for establishing public health policy.

Dr. Henderson: In relation to my colleague, Dr. de Klerk’s, observations, I would have to agree with him. I was struck in Professor McDonald’s comments that he pointed to the consistency of the high lung cancer risk among textile cohorts. He also indicated that the explanation for this difference between the textile workers and other groups of workers still awaits elucidation. We have no clear explanation for this difference. In the absence of something which we cannot explain and therefore take measures to control, prudence should lead us to take the position of maximal caution because we don’t know that the extremely low risk of lung cancer found in the Quebec chrysotile miners and millers will be translated across other cohorts. In this respect, it’s what I said in one of my earlier reports that when in doubt, or there are uncertainties or lack of observational data in comparison with cohorts, one adopts a principle of “first do no harm” or when in doubt play it safe for the setting of national occupational health policy. I was also heartened to hear Professor McDonald basically say that there is a modest risk of lung cancer at low levels, that he did endorse the linear relationship model and he did state that the explanation for these differences is not clearly known. Because of these uncertainties concerning risk, I would adopt the same policy as Dr. de  Klerk and argue that one takes a conservative scenario in order to avoid a risk of harm – here we’re talking about cancers with close to a 100 per cent mortality rate – for the benefits of the average population. (See Appendix 2).

Conclusion

Despite saying that McDonald’s conclusion that asbestos is “essential innocuous” was “reviewed by many generations of competent peer reviewers” (p.11), Prof. Fuks cites no peer review reports (not even the peer review that presumably occurred prior to the publication of the paper to support this argument). We know that no peer reviewer ever had access to or evaluated the data cited in the series of papers. Dr. McDonald cites Dr. Sebastien as the source of his central-peripheral tremolite theory data. Dr. Sebastien claims he has never seen such data and denies that he ever conducted such an analysis.xxx Dr. Case, a co-author of several papers in the series, does not know which mine is which.xxxi

Peer review begins rather than ends publication. The main peer researchers at Mount Sinai were highly critical of the McGill work. Liddell revealed the vitriol of the contemporaneous peer review in an editorial:

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Ignoring the word ‘severe’ in the preceding sentence, an anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news. These included: all workers ever exposed to asbestos will die prematurely of asbestos-related disease; all forms of asbestos are equally hazardous; one asbestos fibre can kill; any substitute for asbestos must be less harmful. Like all myths, they were inventions without foundation and entirely untrue, but they were welcomed by the media and promulgated so ardently that they were soon almost universally believed, engendering widespread ‘fibrephobia’; the anti-asbestos lobby (hereinafter The Lobby) became both influential and powerful. When the first findings from Quebec were published they threatened to dispel the myths, and so The Lobby tried to denigrate them. As this could not be done on scientific grounds, a campaign of intense malice was conducted against the principal Quebec investigator. And of course any group, such as that at Tulane University in New Orleans, which found evidence contrary to the myths was also castigated or even ostracized. Nevertheless, honest scientists have continued their endeavors, and what follows provides some background to the study that is reported in the accompanying paper (p. 13).xxxii

In June 2012, several months before the release of Prof. Fuks report, the Joint Policy Committee of the Societies of Epidemiology (JPC-SE) released its position statement on asbestos. Its conclusions on the quality and impact of the McGill studies mirrored those in my complaint. In fact they cited and validated the findings of my 2003 published critique of the McGill studies.

The Canadian asbestos industry is largely responsible for creating and advancing the idea that chrysotile asbestos is safer than asbestos of other fibre types (McCulloch and Tweedale, 2008). Egilman and colleagues (2003) previously evaluated published and unpublished studies carried out by researchers at McGill University and funded by the Quebec Asbestos Mining Association (QAMA). These QAMA-funded researchers had claimed that Quebec-mined chrysotile was essentially harmless and that the contamination of chrysotile with oils, tremolite or crocidolite was the source of occupational health risk. Careful review of these claims revealed unsound selection, sampling, and analytical techniques, with the rejection of their contention that chrysotile was “essentially innocuous”. Nevertheless, these refuted QAMA-funded studies have been used to promote the marketing and sale of asbestos, with a substantial effect on policy and occupational health litigation. (Egilman et al., 2003; Bohme et al., 2005).xxxiii

Prof. Fuks failed to cite these critical peer review findings.

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The McGill findings were not consistent with those of others in the research community. Of course, even if they were consistent, consistency is not a proxy for accuracy and is not evidence that the data was not fabricated.

Prof. Fuks’ failure to confront the absence of the Sebastien data is astounding. The disappearance of this data (if it ever existed) was one of only three questions (allegations) that Dr. Egilman made in his letter to Drs. Eidelman and Fuhrer. This data is the cornerstone of the entire high-low tremolite area article.

It is particularly appalling that Prof. Fuks has simply washed his hands with regard to the missing data, since the very reason that Dr. Eidelman referred the matter to Prof. Fuks was because the then Chair of McGill’s Department of Epidemiology, Dr. Rebecca Fuhrer, who Dr. Eidelman appointed to carry out an internal investigation of the allegations, was unable to obtain the required records and data. Dr. Eidelman sent out the following statement on April 4, 2012:

Statement from David Eidelman, Vice-Principal (Health Affairs) and Dean of Medicine

Dear members of the McGill community,

On February 9, I shared with you the decision that the Faculty of Medicine had begun a preliminary review of allegations relating to McGill Prof. J. Corbett McDonald’s research on asbestos. The purpose of this review, which followed the broadcast of a CBC documentary and the publication of a letter sent to the Chancellor, Principal and Chair of McGill’s Board of Governors, was to gather data – independent of the news reports – to determine whether the matter should be referred to the office of McGill’s Research Integrity Officer (RIO).

As you know, research is a vital part of the University’s mission, and McGill researchers are required to perform their work according to the highest ethical standards. The University’s role is to provide a framework for research excellence and integrity in the public’s interest and in an environment that supports academic freedom, a responsibility we take seriously.

At my request, Prof. Rebecca Fuhrer, Chair of the Dept. of Epidemiology, Biostatistics and Occupational Health, carried out the preliminary review. I am grateful for the dedication and diligence with which she undertook this mandate. Although the report does not identify evidence of research misconduct, it is my conclusion that the Faculty does not currently have all required records and data in hand to assess definitively in regard to research integrity.

Consequently, I have asked for additional guidance from the office of the RIO under Section 4.2 of the Regulations Concerning Investigation of Research

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Misconduct, which states that, “Where a person is unsure whether a suspected incident constitutes Research Misconduct, he or she should seek guidance from the RIO.” Note this is not a request to the RIO for an official investigation at this time.

I will keep you informed regarding the outcome of this process.

Prof. Fuks admits that he, like Dr. Fuhrer, does not have all the required records and data in hand. Like Dr. Fuhrer, he is thus not able “to assess definitively in regard to research integrity.” It is a betrayal of ethical standards that Prof. Fuks simply and conveniently dismisses the allegations, while admitting that he does not have “the required records and data.”

Prof. Fuks’ explanation that Dr. McDonald was consistent in using the same flawed methodology does not constitute evidence that there was no wrongdoing: clearly a person can consistently or inconsistently manipulate data. In both cases, this is academically and ethically unacceptable.

Prof. Fuks’ report fails completely to address any of the three serious questions that Dr. Egilman put before him.

Question 1: Did McGill researchers manipulate the study data and did the manipulated results show that Canadian asbestos only caused cancer after massive exposures?”

Question 2: What was the location of the “high and low tremolite mines”?

Question 3: Where is the Sebastien data that shows there were low and high tremolite levels in “Central and Peripheral” mines?

Appendix One

FUNDER, NONE: 1969 Gibbs, Graham. The organic geochemistry of chrysotile asbestos especially from the eastern townships Quebec, Department of Geological Sciences, McGill University, July, 1969.

FUNDER, Q.A.M.A.: 1970 McDonald, AD, Harper, A, El Attar, OA, and McDonald, JC., Epidemiology of primary malignant mesothelial tumors in Canada, Cancer, Vol. 26, October, 1970, pp. 914-919

FUNDER, Q.A.M.A.: 1970 Gibbs, Graham. Qualitative aspects of dust exposure in the Quebec asbestos mining and milling industry, Inhaled particles; proceedings of an international symposium organized by the British Occupational Hygiene Society., 1970.

FUNDER, Q.A.M.A.: 1971 McDonald, JC, McDonald, AD, Gibbs, GW, Siemiatycki, J, and Rossiter, CE., Mortality in the chrysotile asbestos mines and mills of Quebec, Arch Environ Health, Vol. 22, June, 1971, pp. 677-686.

FUNDER, Q.A.M.A.: 1972 Gibbs G. and Lachance, M. Dust exposure in the chrysotile asbestos mines and mills of Quebec, Arch Environ Health, Vol. 24, March 1972

FUNDER, NONE.: 1973 McDonald, JC, Cancer in chrysotile mines and mills, IARC Scientific Publications No. 8, Biological effects of asbestos — Proceedings of a working conference held at the [IARC], Lyon, France, 2-6, October, 1972, 1973.

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FUNDER, NONE: 1974 McDonald, JC, Becklake, MR, Gibbs, GW, McDonald, AD, Rossiter, CE., The health of chrysotile asbestos mine and mill workers of Quebec, Arch Environ Health, Vol. 28, Feb 1974, pp. 61-68.

FUNDER, Q.A.M.A.: 1974 Gibbs, G and Lachance, M. Dust-fiber relationships in the Quebec chrysotile industry., Arch Environ Health, Vol. 28, February 1974.

FUNDER, Q.A.M.A.: 1979 Gibbs, GW. Etiology of pleural calcification: a study of Quebec chrysotile asbestos miners and millers, Arch Environ Health, March/April 1979, pp. 76-83.

FUNDER, Q.A.M.A.: 1980 McDonald, JC, Liddell, FDK, Gibbs, GW, Eyssen, GE, and McDonald, AD., Dust exposure and mortality in chrysotile mining, 1910-75, Brit Journal of Industrial Medicine 1980; 37: 11-24.

FUNDER, Q.A.M.A.: 1980 McDonald, AD., Malignant mesothelioma in Quebec, Biological Effects of Mineral Fibers, 1980, pp. 673-680.

FUNDER, Q.A.M.A.: 1980 McDonald, AD and McDonald, JC., Malignant mesothelioma in North America, Cancer 46:1650-1656, 1980.

FUNDER, GOVT., U.S.NIH: 1981 Cohen, D, and Crowther, T, and Gibbs, GW and Becklake, MR., Magnetic lung measurements in relation to occupational exposure in asbestos miners and millers of Quebec., Environ Research 26, 535-550 (1981).

FUNDER, Q.A.M.A.: 1982 McDonald, AD, McDonald, JC, and Pooley, FD., Mineral fibre content of lung in mesothelial tumours in North America, Ann Occup Hyg, Vol. 26, Nos. 1-4, pp. 417-422, 1982.

FUNDER, Q.A.M.A.: 1982 McDonald, AD, and Fry, JS., Mesothelioma and fiber type in three American asbestos factories – preliminary report, Scand J Work Environ Health, 1982, Suppl 1, 53-58.

FUNDER, Q.A.M.A.: 1982 McDonald, AD, Fry, JS, Woolley, AJ, and McDonald, JC., Dust exposure and mortality in an American factory using chrysotile, amosite, and crocidolite in mainly textile manufacture., Brit J Indus Med 1982;39:368-374.

FUNDER, NONE: 1982 Rowlands, N., Gibbs, GW, and McDonald, AD., Asbestos fibers in the lungs of chrysotile miners and millers – a preliminary report.1983 X McDonald, AD, Fry, JS, Woolley, AJ, and McDonald J. Dust exposure and mortality in an American chrysotile textile plant., British Journal of Industrial Medicine, 1983:40:361-367.

FUNDER, NONE: 1984 McDonald, JC, Mineral fibers and cancer, Annals Academy of Medicine, April, 1984, Vol. 13, No. 2 (Suppl.), pp. 345-352.

FUNDER, Q.A.M.A.: 1984 McDonald, AD, Fry, JS, Woolley, AJ, and McDonald, JC., Dust exposure and mortality in an American chrysotile asbestos friction products plant, Brit J Indus Med, 1984;41:151-157.

FUNDER, NONE: 1984 Liddell, FDK, Thomas, DC, Gibbs, GW, McDonald, JC., Fibre exposure and mortality from pneumoconiosis, respiratory and abdominal malignancies in chrysotile production in Quebec, 1926-1975.

FUNDER, GOVT.: 1987 Case, B. and Sebastien, P., Environmental and occupational exposures to chrysotile asbestos: a comparative microanalytic study. Archives of Environmental Health, July/August 1987, Vol. 42, no. 4.

FUNDER, GOVT.: 1988 Case, BW, Sebastien, P, McDonald, JC., Lung fiber analysis in accident victims: a biological assessment of general environmental exposures, Arch Environ Health, March/April, 1988 [Vol. 43, (No. 2)], pp. 178-179

FUNDER, GOVT.: 1989 McDonald, JC, Armstrong, B, Case, B, Doell, D, McCaughey, WTE, McDonald, AD, and Sebastien, P., Mesothelioma and asbestos fiber type — evidence from lung tissue analyses, Cancer 63:1554-1547, 1989.

FUNDER, GOVT.: 1991 Gibbs, AR, Stephens, M, Griffiths, DM, Blight, BJN, Pooley, FD, Fibre distribution in the lungs and pleura of subjects with asbestos related diffuse pleural fibrosis, British Journal of Industrial Medicine 1991;48:72-770

FUNDER, GOVT.: 1991 Case, B, Health effects of tremolite – now and in the future, New York Academy of Sciences, 1991, v. 643, pp. 491-504.

FUNDER, GOVT.: 1993 McDonald, JC, Liddell, FDK, Dufresne, A, McDonald, AD., The 1891-1920 birth cohort of Quebec chrysotile miners and millers: mortality 1976-1988, British Journal of Industrial Medicine, 1993; 50:1073-1081.

FUNDER, NONE: 1994 Gibbs, GW, The assessment of exposure in terms of fibres, Ann Occup Hyg, Vol. 38, No. 4, pp. 477-487, 1994.

FUNDER, NONE: 1994 McDonald, JC, Epidemiological significance of mineral fiber persistence in human lung tissue, Environ Health Perspect, Vol. 102, Suppl 5, October, 1994.

FUNDER, NONE: 1997 McDonald, JC, and McDonald, AD, Chrysotile, tremolite and carcinogenicity, Ann Occup Hyg, Vol. 41, No. 6, pp. 699-705, 1997.

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FUNDER, NONE: 1997 McDonald, AD, Case, BW, Churg, A, Dufresne, A, Gibbs, GW, Sebastien, P, and McDonald, JC, Mesothelioma in Quebec chrysotile miners and millers: epidemiology and aetiology, Ann Occup Hyg, Vol. 41, No. 6, pp. 707-719, 1997.

FUNDER, NONE: 1997 Case, BW, Churg, A, Dufresne, A, Sebastien, P, McDonald, A, and McDonald, JC, Lung fibre content for mesothelioma in the 1891-1920 birth cohort of Quebec chrysotile workers: a descriptive study, Ann Occup Hyg, Vol. 41, Supplement 1, pp. 231-236, 1997.

FUNDER, NONE: 1998 McDonald, JC. Mineral fiber persistence and carcinogenicity, Industrial Health 1998, 36, 372-375.

FUNDER, NONE: 1998 McDonald, JC. Invited editorial: Unfinished business: the asbestos textiles mystery, Ann Occup Hyg, Vol. 42, No. 1, pp. 3-5, 1998.

FUNDER, NONE: 1999 McDonald, JC, McDonald, AD, and Hughes, JM., Chrysotile, tremolite and fibrogenicity., Ann Occup Hyg, Vol. 43, No. 7, pp. 439-442, 1999.

Appendix 2: World Trade Organization, ANNEX VI. Meeting with Experts – 17 January 2000,

WT/DS135/R/Add.1.

Transcript

[page165, paragraph 145]

Dr. Henderson

Well if the question is asked why do I use it? The answer is many others do also. In relation to the comment about oil, I may not have expressed myself with clarity. I was not saying that oil was not used – what I am saying is that studies on the carcinogenicity of the oil have yielded negative results and cannot explain the difference between the two worker cohorts. I think this point was made by Professor McDonald himself in a recent editorial on this issue, that really the difference for the dose-response line for the two groups for lung cancer remains basically unexplained. Because we do not know the explanation, it is difficult then to control for whatever that unknown factor is. In approaching national policy for occupational health and safety, one often adopts a prudent approach, using a conservative or worst-case scenario on the “first do no harm” principle. When it comes to the fact that the two groups are different from, for example, asbestos-cement manufacture, I don’t dispute for a moment that asbestos and friction product manufacture nowadays carries a very low risk because there is a low airborne fibre concentration with low cumulative exposures. The reasons why I use the Charleston group as an approach is that it identified a high lung cancer risk at low exposure and that the types of fibre released during that operation can be released during end-work, that is machining asbestos-cement products. If this can produce comparable cumulative exposures, one needs to assume that we have not proven that those exposures will have no effect. Therefore it is basically an approach of safety and prudence for the formulation of the national health policy.

The other thing is, I’ll just reiterate, that if you go to the Abstract for the paper by Drs. Case and others, they themselves said that the risk assessment for asbestos exposure for lung cancer is based on lung cancer risk for the textile workers rather than the miners and the millers. The question is which is the outlier – do you take the Charleston textile group as the outlier and ignore it or do you say, well, perhaps there is something peculiar about the Quebec chrysotile miners and millers and, in terms of their exposure and dose response, then they are an outlier in that they showed a very low slope to the lung cancer dose-response line. Other studies have showed an intermediate risk. So the question is which one do you adopt for formulation of national health policy?

Chairman

As we conclude the morning sessions, could I perhaps make a couple of comments which might help us into the afternoon? Just looking at the questions and the discussion so far, it seems to me that we have had some quite good coverage of the first broad subject which is chrysotile itself. From the Panel’s point of view, it will be important that we also have some time to discuss the two other broad topics of controlled use and substitute fibres. So I’d reiterate my request or my suggestion to the parties to be

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selective in their questions and comments. It obviously is not going to be possible to deal with all the issues in an exhaustive manner. So what we will do, I think, is see how we progress in the afternoon. The Panel will want to make sure that there is time for those other two issues I mentioned and we may have to make time for those issues and then come back to the first set of issues concerning chrysotile at the end if we have time. I’d also ask the parties, when you are asking your questions, could you please as far as possible refer directly to either the Panel’s original questions or to the parts in the experts’ reports where they have addressed these issues so that it is easier for the experts to respond and see exactly what you are each referring to, especially when we have cases of some of the studies that have been cited. They are usually there in the material somewhere, but perhaps sometimes a page reference would be helpful to enable the experts to respond more quickly. We will reconvene at 3 p.m. Thank you very much.

[Lunch break]

17 January 2000, p.m.

Chairman

We were part way through the discussion of one question. I just checked with Mr. Hankey as to how far through the list of those questions relating to the first four questions submitted by the Panel Canada was and I understand that they’ve made very good progress through them. So that being the case, I think we will continue on with this current question where there may be one or two comments still to be heard, then proceed on through the remaining one or two questions concerning the first broad heading of chrysotile asbestos itself. That would then give us adequate time to work through controlled use and the question of substitute fibres. I would really express the hope that by 3.30 we should be beginning our discussion of controlled use. If that is acceptable, we now open the floor. We were in the midst of a discussion, there was a point that had been made by Mr. Christoforou which had not yet been responded to. I think Canada also had one or two additional elements that they wanted to mention. So unless the experts feel that they need to add any points to the reponses they have given so far, I could pass the floor back to Canada if you were following up on the question currently under discussion. Then we can ask the experts to respond to Mr. Christoforou’s point.

Mr. Hankey (Canada)

Thank you Chairman. Our follow-up just has to do with this issue that in the absence of much direct data on the use of chrysotile-cement products in the construction industry, what would constitute a good paradigm or surrogate among the various studies that do exist. We know that there are close to sixty studies about the use of chrysotile asbestos and we have had a lot of reference to the Charleston study: Charleston is wonderful for the jazz festival but I am not so sure it is very relevant for the issue before the tribunal. So Dr. McDonald would address the issue of what he thinks might be a more appropriate paradigm or surrogate to examine the issue of risk exposures in the use of chrysotile-cement. Thank you,

Dr. McDonald.

Dr. McDonald (Canada)

I’ll try to be as brief as I can. The first point being that, of course, the Charleston cohort of textile workers is not unique in textile cohorts. There have in fact been three: one, Charleston, is almost entirely chrysotile but there are two others which have been mentioned briefly, in which there were substantial amounts of crocidolite used. I only want to make the point that all three of these textile cohorts show this anomalous high level risk of lung cancer, whether it was chrysotile or whether there were amphiboles, whereas so far as mesotheliomas are concerned, the presence of crocidolite clearly correlated with the incidence of mesothelioma. In other words, there was no excess of mesothelioma in the Charleston cohort, any more than there is in asbestos mining and milling. Whereas in the other two textile cohorts, there were substantial numbers of mesotheliomas. Therefore, those of us who have been trying to understand why the textiles are different conclude, I think, that there is something funny about textiles. It

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is precisely that point that makes me say I would be personally wondering why you would choose something anomalous rather than something that is in line with the rest. I refer now to the fact that by far the biggest scientific study of chrysotile workers is the one of chrysotile miners and millers in Quebec which has been of some 11,000 men studied continuously for 35 years and now 80 per cent of them are dead. So we have one of the most complete pictures of mortality in chrysotile workers almost … than you can imagine. There is nothing comparable. These men were exposed in the 1930s and 1940s to astronomically high levels of chrysotile exposure. Now the issue of exposure levels has been questioned, if you like, by Dr. Infante who said that the methods used in the Quebec cohort were different from those in Charleston. I would like to point out that it is not so. We also estimated exposures individually in relation to fibre conversion and in fact published a detailed report in 1980, showing that the risk estimate based on individual estimations by fibre gave us exactly the same estimate risk as using the average. I can give the reference for that: it was published in an international meeting in Lyon by the IARC and I am sure Dr. Infante is familiar with it. I hope that that would reassure him that there is no reason to think that the exposure estimates in Quebec were any better or any worse, shall I say, than in Charleston. In fact, they were based on a very much larger amount of data, a very much larger, with parallel counts by fibre and dust, as in Charleston. There was no difference. So we are left with the fact that Charleston is an anomaly. Now I don’t want to go into the Quebec result in detail but we have 8,000 deaths which is, I suppose, as big as there is in any study. What everybody, I think, is familiar with, is the fact that it showed a very modest risk of lung cancer, except at quite high levels. Indeed, the cohort mentioned as asbestos cement workers in that part by Hughes, in the part of the study which was chrysotile only, gave a slope almost identical with the miners and millers. I would also point out that the type of work in mining and milling, in which you sort out the fibres, is very similar to that in cement workers and in friction product workers, very similar and quite different from that in textile workers. And what that showed, as I say, was a very modest increase at low levels, a substantial increase of lung cancer at high levels, a substantial one, but at levels below about 25 fibres per c.c. for forty years’ work, we could not detect an increase in lung cancer. It doesn’t mean there wasn’t one. We’re quite prepared to accept the concept of a linear relationship but the fact remains that for people below that level, we couldn’t detect any increase. This is a very big cohort. Equally, yes, there were mesotheliomas in this cohort but not very many in relation. There were 33 deaths from mesothelioma in miners and millers: not a single one in a man who had worked for less than two years and only one in a man who had worked for less than twenty years. Surely that suggests that the risk of exposure in that very large cohort was quite modest and that exposures at modern levels of say one fibre per c.c. wouldn’t possibly be detectable. But I would submit to you that surely this experience is much more in line with asbestos cement and friction product workers than textile workers, the explanation of which we really don’t know.

Chairman

Thank you, Dr. Infante.

Dr. Infante

Dr. McDonald, you made some comment that the Hughes study gave a slope identical to … I didn’t understand then which group you were referring to?

Dr. McDonald (Canada)

You will recall there were two plants in the Hughes study, one of which was thought to be essentially chrysotile only and gave a slope of 0.0003 if I remember, which is when I say identical, almost identical with the slope in Quebec. That was one. Not the crocidolite one which was something like 25 times higher.

[…]

[page 172, paragraph 178]

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Dr. Infante

If I look at the document 203, on page 109 and table 23, they list several studies on friction materials production. The study overall by Newhouse and Sullivan does not show any excess like the SMR is 93, the study by McDonald et al. 94, (we’re talking lung cancer now), shows a statistically significant excess. Then there are mixed products in friction materials, several of those, in fact all of them, show a significant excess of lung cancer. Granted that these are mixed products, but nevertheless they show an excess and you can’t totally discount, in my opinion, the chrysotile contribution. The study by McDonald et al. in 1984 shows a significant excess in lung cancer and the majority of that excess, not all, was in short-term workers. That’s noteworthy in that study. So you say, well what does that relate to? I think you have to know something about the short-term workers to know why you have the excess in short term workers, It’s not the first study: workers exposed to beryllium, they were exposed for a short time, show a significant excess of lung cancer and it was all initially in the short-term workers. We know that beryllium is a human lung carcinogen. What the study shows in terms of dose-response is that there is not much potency. One of the problems in doing dose-response in the study is that you have this excess in the short-term workers. So you are not going to expect in that study to find a dose-response because presumably the short-term workers had low exposure and that was the majority of individuals in the study. You are not going to expect to be able to find a dose-response and there is not a lot of statistical power in that study when you go beyond the short-term workers. You can have a U-shaped curve in terms of the dose-response; you have a high risk in the low-exposed group, you have a slightly lower risk in the medium and you have a high risk in the highest exposed group. I don’t know what you can say about dose-response in that study given that you have got some kind of observation that you need to try and understand, in my opinion, before you do dose-response.

Chairman

Would any of the other experts want to add anything to the point made by Dr. Infante? Dr. de Klerk.

Dr. de Klerk

Can I just semi-respond to Corbett McDonald’s points earlier on. I just think that they need some kind of reponse because his basic conclusion, I thought, was that because the textile industries were different, because they had higher risks of lung cancer, then we should ignore them in terms of setting health standards. I suggest that’s not really the way you should go about setting health standards. The one thing they all have in common is they’re textiles but they are also chrysotile. Therefore, as Professor Henderson has been saying, in terms of setting prudent health policies, if you’ve got some evidence that a substance is dangerous and then it’s going to be used by a lot of people where the properties are unknown and, I thought we’d agreed earlier on that the majority of people we are concerned about are not friction product manufacturers, asbestos-cement manufacturers, we’re worried about the people using the products later on and we don’t know what characterizes their exposure, only that they will be exposed to chrysotile. We have some evidence that chrysotile is dangerous. We have a lot of evidence that it’s dangerous and that we are not in a position to control that exposure. So, to say that we should ignore evidence that it is dangerous, I think is imprudent at best.

Chairman

Thank you. Professor Henderson.

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Dr. Henderson

In relation to my colleague, Dr. de Klerk’s, observations, I would have to agree with him. I was struck in Professor McDonald’s comments that he pointed to the consistency of the high lung cancer risk among textile cohorts. He also indicated that the explanation for this difference between the textile workers and other groups of workers still awaits elucidation. We have no clear explanation for this difference. In the absence of something which we cannot explain and therefore take measures to control, prudence should lead us to take the position of maximal caution because we don’t know that the extremely low risk of lung cancer found in the Quebec chrysotile miners and millers will be translated across other cohorts. In this respect, it’s what I said in one of my earlier reports that when in doubt, or there are uncertainties or lack of observational data in comparison with cohorts, one adopts a principle of “first do no harm” or when in doubt play it safe for the setting of national occupational health policy. I was also heartened to hear Professor McDonald basically say that there is a modest risk of lung cancer at low levels, that he did endorse the linear relationship model and he did state that the explanation for these differences is not clearly known. Because of these uncertainties concerning risk, I would adopt the same policy as Dr. de Klerk and argue that one takes a conservative scenario in order to avoid a risk of harm – here we’re talking about cancers with close to a 100 per cent mortality rate – for the benefits of the average population.

Chairman

Thank you. Dr. Infante wanted to come back on a point.

Dr. Infante

I wanted to comment on what Dr. McDonald had said earlier. I think his point was that why would one rely on Dement’s study or the other studies of chrysotile-textile workers when the results seem so different from the results from the miners and millers study that he conducted. He also indicated that the Hughes study of asbestos-cement production workers gave a slope closer to the slope of the miners and millers study. Is that … , you are shaking your head? Yes, that’s right. But as I look at the data from the Hughes study, it gives a slope closer to the textile workers study and he just said that the cement production would be closer to miners and millers. When you look at the slope from the Hughes study, if you look on page 168 of that study, they indicate that for the chrysotile group only the slope, this is per unit of fibre, the slope is 0.01 for the chrysotile group and 0.016 for the mixed fibre groups. So it appears to me that that slope is closer; that’s close to what the slope is from the study of the textile workers based on McDonald’s Pennsylvania cohort and the Rochdale study done by Peto which is about 1 per cent, and it’s a little lower than that based on the Dement study which shows 2 to 3 per cent.

Chairman

Professor McDonald.

Dr. McDonald (Canada)

I would like to say that the slope in the textiles is of the order of 0.1. The slope in the Hughes chrysotile plant was 0.0003. That is indeed approximately similar to the Quebec chrysotile miners and millers. We agree entirely that the textile plants are out of line with that by an approximately a fifty-fold difference. All I can say is that the Quebec plant is not isolated. The thing that is isolated are the textile workers. The Quebec miners and millers are similar to the cohorts of the chrysotile cement workers and similar to the cohorts of friction product workers. Indeed, there are only something like eight studies where anybody has measured the exposure at all. And seven of the eight agree with the miners and millers and only the textile workers don’t. I would agree that if we had to decide about the continuation of textile work, we would be absolutely right to say let’s be careful about it. But that’s seems to me a rather historical question.

Chairman

(PAGE 29)

Another comment from Dr. Infante.

Dr. Infante

I just have one point of clarification. The risk of 0.0003 that you indicated for asbestos-cement production according to the document 203, that is the potency estimate for use at plant 1 which was chrysotile, crocidolite and amosite. The risk level for plant 2, which I understand is chrysotile only, was 0.007 and so that’s 0.7 per cent.

Dr. McDonald (Canada)

It’s the other way round, but I’d say we really ought to discuss this somewhere else.

Chairman

Well, could I suggest that we should now try to focus ourselves solidly on controlled use, given that most of the discussion so far in this afternoon session has tended to follow on from really the same issues as the morning session. As I say, if we have time at the end of our meeting after we’ve managed to deal with both controlled use and some aspects of substitute fibres, maybe we can come back and continue some of the discussion covering the first four broad questions of the Panel. Are the parties ready now to address issues specifically concerning controlled-use? I think probably the floor is to Canada for the next main question.

[…]

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i Egilman, D. (2002). Letter to Robert E. MacKenzie, Associate Dean, Graduate Studies and Research, Faculty of Medicine, McGill University, September 15, 2002.

ii Egilman, D, Fehnel, C, Bohme, SR. (2003). Exposing the “Myth” of ABC, “Anything But Chrysotile”: A critique of the Canadian asbestos mining industry and McGill University chrysotile studies. American Journal of Industrial Medicine, 44(5): 540–557

iii Fuks, A. (2012). Consultation Report to Dean David Eidelman. McGill University, September 23.

iv Sebastien, P. email exchange with Corey Fehnel. 5 September 2001 to 30 October 2001.

v F. D. K. Liddell,· A. D. McDonald and J. C. McDonald (1997). The 1891-1920 Birth Cohort Of Quebec Chrysotile Miners And Millers: Development From 1904 And Mortality To 1992, Annals of Occupational Hygiene, 41(1): 13-36.

vi Cohen, D, Crowther, T, Gibbs, GW and Becklake, MR. (1981). Magnetic lung measurements in relation to occupational exposure in asbestos miners and millers of Quebec. Environmental Research 26:535-550.

vii Brodeur, P. (1974). Expendable Americans: The incredible story of how tens of thousands of American men and women die each year of preventable industrial disease. Viking Adult: New York. viii Ibid pages 133-134.

ix Ibid.

x McDonald JC, Liddell FD, Gibbs GW, Eyssen GE, and McDonald AD. (1980). Dust exposure and mortality in chrysotile mining, 1910-75. British Journal of Industrial Medicine, 37(1):11-24.

xi Examination of Dr. John Corbett McDonald. 4 December 1984. Ramona Jones, individually and as Executrix of the Estate of Fay Jones vs. Turner & Newall, LTD. et al. In the Superior Court of the State of Washington in and for the County of King.

xii Ibid. Discovery Deposition of Dr. J. Corbett McDonald. 9 January 1989. Robert Williams vs. Anchor Packing, et al. in the Circuit Court, Third Judicial Circuit, Madison Country, Illinois. Deposition of Dr. J. Corbett McDonald. (date)*. Sherry Wolff et al. Constituting the Washington County, Tennessee Board of Education vs. United States Gypsum Company and W.R. Grace & Co. In the United States District Court for the Eastern District of Tennessee Northeastern Division. Examination of J. Corbett McDonald, M.D. 9 May 1989. In Re: Asbestos Cases, Volume 28; The Circuit Court of Kanawha County, West Virginia. Deposition of Dr. John Corbett McDonald. 11 May 1987. Charles Warren Smith vs. Raymark Industries, Inc., et al. In the Superior Court of the County of Los Angeles, California Law Division. Deposition of Dr. J. C. McDonald. 12 July 1986. School District of Independence Missouri No. 30 vs. U.S. Gypsum Company, et al. In the Circuit Court of Jackson County, Missouri. Examination of John C. McDonald. 23 January 1986. City of Greenville and Greenville Water System vs. W.R. Grace & Co. In the United States District Court for the District of South Carolina Greenville Division. Testimony of John Corbett McDonald. DATE.* Eagle-Picher Industries, Inc. vs. American Motorists Insurance Co. United States District Court, District of Massachusetts.

xiii Q.A.M.A. Minutes, April 8, 1970.

xiv Q.A.M.A. Research Institute of Occupational Health in Montreal. Record of discussions with Dr. John Beattie at Rochdale on 14th December, 1965 and with Mr. K.V. Lindell in New York on 15th December, 1965.

xv Liddell, FD., McDonald, AD. and McDonald, JC. (1998). Dust Exposure and Lung Cancer in Quebec Chrysotile Miners and Millers. Annals of Occupational Hygiene 42(1):7-20.

xvi Shapiro, H. A. (1969). Pneumoconiosis: Proceedings of the international conference, Johannesburg, 1970, Cape Town, S. Africa, Oxford University Press.

xvii Gibbs, G. W., Lachance, M. (1974). Dust-fiber relationships in the Quebec chrysotile industry.” Arch Environ Health, 28:69-71

xviii Liddell, FD, Fibre exposure and mortality from pneumoconiosis, respiratory and abdominal malignancies in chrysotile production in Quebec, 1926-75. Annals of the Academy of Medicine, Singapore 0304-4602 1984-04. 13(2) suppl:340-344.

xix Examination of Dr. John Corbett McDonald. Royal Commission on Matters of Health and Safety Arising from the Use of Asbestos in Ontario Vol. XII, p.42.

xx Liddell, FD., McDonald, AD., and McDonald, JC. (1998). “Dust Exposure and Lung Cancer in Quebec Chrysotile Miners and Millers.” Annals of Occupational Hygiene, 42(1):7-20.

xxi Presentations of Canadian and Brazilian Governments at WTO hearings opposing France’s ban on asbestos imports. http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds135_e.htm

xxii Hodgeson JT and Darnton A. (2000). The quantitative risks of mesothelioma and lung cancer in relation to asbestos exposure. Annals of Occupational Hygiene 44(8):565-601.

xxiii McDonald, JC. (1998). Invited Editorial: Unfinished Business: The Asbestos Textiles Mystery. Annals of Occupational Hygiene, 42(1):3-5, 1998

xxiv Ibid.

xxv Pearce, Christine. Email to David Egilman, Re: Status of submission to science, Monday February 11, 2002.

xxvi Fehnel, C. and Egilman D. February 20, 2002 email to Christine Pearce.

xxvii Sebastien, P. email exchange with Corey Fehnel. 5 September 2001 to 30 October 2001.

xxviii Gibbs, G.W. (1979). Etiology of Pleural Calcification: A Study of Quebec Chrysotile Asbestos Miners and Millers. Archives of Environmental Health, 34(2):75-83.

xxix Gibbs G. and Lachance, M. (1972). Dust exposure in the chrysotile asbestos mines and mills of Quebec, Arch Environ Health, 24.

xxx Sebastien, P. email exchange with Corey Fehnel. 5 September 2001 to 30 October 2001..

xxxi Deposition of Bruce Case. In David Alber and Joyce Alber v. United States Gypsum Company, et al. August 22, 2001.

xxxii Liddell FD. (1997). Magic, menace, myth and malice. Annals of Occupational Hygiene. 41(1):3-12

xxxiii http://www.jpc-se.org/position.htm