Good, impartial science can help save lives, by identifying life-threatening exposures at work and identifying measures – controls, safer standards, bans on the deadliest substances - to remedy them. Asbestos would be a case in point. For those for whom the science came too late, the ones forming part of the body count, it can mean at least some compensation for a life cut short.
STACKED EVIDENCE US building products giant Georgia-Pacific is accused of “seeding” the scientific literature against the interests of asbestos cancer claimants. If the courts accepted the disputed findings of the GP-funded research, very many asbestos-exposed cancer sufferers could go uncompensated because they were exposed to the wrong kind of “shorter” chrysotile fibres, were not exposed at high enough levels or, if exposed at a high level, not exposed long enough. Global exports of chrysotile increased by 20 per cent in 2012.
It is a high stakes business and was at the heart of a New York Supreme Court Appellate Division hearing in June 2013.1 The appeal court upheld a New York Supreme Court ruling that found a series of academic, scientific papers commissioned and used by US building products giant Georgia-Pacific (GP) in a bid to frustrate asbestos cancer compensation claims were potentially part of a “crime-fraud.”
The judges said the papers, written and initially published by authors with undeclared conflicts of interest, were intended to “cast doubt” on a cancer link. The eleven papers,2-12 published in the journals Inhalation Toxicology, the Journal of Occupational and Environmental Hygiene, the Annals of Occupational Hygiene and Risk Analysis were referred to in court depositions by GP’s Stewart Holm, as “litigation-driven research.”
A prominent UK researcher, Edinburgh University Professor Ken Donaldson, is a co-author with Holm and others of three of the papers.2-4 Concerns about his undeclared links in these papers to some asbestos interests and a flat and flatly untrue denial of any links in another journal have led to questions about his high profile role in a forthcoming international conference on workplace dust exposures.
Professor Donaldson (right) is on the organising committee of the prestigious Chartered Society for Worker Health Protection (BOHS) Inhaled Particles XI conference, which takes place in Nottingham from 23 September 2013. He chairs the international event’s scientific committee and is a keynote speaker.
BOHS president David O’Malley told Hazards that Donaldson was invited “because of his distinguished reputation as a leading international scientist in the toxicology of inhaled particles.” The professor is one of the UK’s most respected occupational hygiene experts and is the 15th most cited academic in air pollution research.13 In 2009, he was appointed an honorary principal scientist at the Institute of Occupational Medicine. He is co-author of a 2013 paper14 calling for the UK’s occupational dust exposure standard to be tightened.
Nonetheless, asbestos disease campaigners are less sanguine about the professor’s participation in the dust conference, and have questioned whether it is appropriate for him to continue in such a high profile role while the “crime-fraud” controversy remains unresolved.
Laurie Kazan Allen of the London-based International Ban Asbestos Secretariat (IBAS) told Hazards: “The lack of transparency is what is appalling on this. Donaldson, like many of his co-authors, clearly had an undeclared relationship with Georgia-Pacific. Professor Donaldson says the conclusions of the papers are ‘indisputable’, conclusions the court determined could be part of a Georgia-Pacific bid to deny the asbestos cancer link.”
In a letter to BOHS president David O’Malley, she said: “UK asbestos victims have already signalled their intention to reach out to their members and to the media about this unsatisfactory state of affairs.”
The Donaldson file
• A New York appeal court in June 2013 said scientific papers Professor Ken Donaldson co-authored were intended to “cast doubt” on the link between chrysotile asbestos and cancer. The professor had undeclared conflicts of interest, because he did not reveal in the publication his involvement in defendant Georgia-Pacific’s “asbestos litigation project.” GP’s in-house legal counsel was “intimately involved” in the “supposedly objective scientific studies”, the court found, ruling there had been a potential “crime-fraud.”
• A California court hearing asbestos cases in June 2013 was told of concerns about Professor Donaldson’s undeclared conflicts of interest, noting he had been “hired by GP as a consultant for the asbestos litigation project on an hourly basis and has been paid from time to time on GP asbestos litigation projects since 2006.” Invoices from Donaldson for asbestos related consultancy work with GP were sent to Stewart Holm, the man heading GP’s asbestos litigation project and the conduit to GP’s in-house counsel.
• A 2011 statement by Donaldson in an occupational health journal that he was “not allied to any asbestos manufacturing company nor pro-asbestos pressure group, nor in receipt of funds from any such source” was challenged as “disingenuous at best” and led to questions why, given he was a consultant to GP’s asbestos litigation project, “did he specifically deny any such work in his published letter.” Drafts of the letter, which defended long-time asbestos industry scientific consultant David Bernstein from accusations of “misuse of biased studies”, were provided for comment to Bernstein, who amended the content, and by Bernstein to GP’s Stewart Holm. Bernstein, Holm and Donaldson were among the co-authors of three of the potential “crime-fraud” papers.
At the heart of the court controversy is a concern that studies presented as impartial evidence were paid for by GP and were produced with the unacknowledged collaboration of the company’s in-house lawyers.
In a 6 June 2013 opinion, the New York Appeal Court said GP, a subsidiary of Koch Industries, “funded these studies in 2005 to aid in its defence of asbestos-related lawsuits.” The five judges noted the papers “were intended to cast doubt on the capability of chrysotile asbestos to cause cancer.”
The papers were not wholly the product of independent scientific minds, the court heard. Lawyers acting for GP played a significant role in their preparation. The opinion noted the authors did not disclose that Georgia-Pacific’s legal counsel participated in lengthy discussions of the manuscripts and suggested revisions.
Commenting on why he believed these are matters of importance, Seth Shulman of the Union of Concerned Scientists (UCS) explained: “Why get worked up about a bunch of technical articles in arcane science journals? Because, as the court noted, there's every indication that those studies were misinformation deliberately planted to cast doubt on the carcinogenic nature of chrysotile asbestos, a component in Georgia Pacific's widely used joint compound for construction projects.”
Approached by Hazards, Professor Donaldson declined to comment on suggestions by UCS that the papers were possibly “counterfeit science” or planted misinformation. He did however say that he welcomed the closer scrutiny ordered by the court and hoped it would show the science was “robust.”
The Holm front
Stewart Holm, a GP employee, was co-author on all three Inhalation Toxicology papers carrying Donaldson’s name. In a June 2011 deposition to the New York Supreme Court, Holm said he had been “specially employed” by GP in 2005 to “perform expert consulting services in connection with pending and anticipated litigation concerning alleged exposure to asbestos.” The scientific papers did not disclose that Holm worked “under the auspices” of the company’s in-house counsel, “who also was significantly involved in the pre-publication review process,” according to the appeal court opinion.
Holm co-authored nearly all of the studies, the court opinion said, adding “it is of concern that GP’s in-house counsel would be so intimately involved in supposedly objective scientific studies, especially in light of the company’s disclosures denying such participation.” Georgia-Pacific commissioned the studies in anticipation of litigation, the judges said. A condition of what Holm described as the “litigation-driven research” was that any publications had to be approved by GP’s chief litigation counsel, John Childs.
GP tried in court to invoke attorney-client privilege to deny lawyers for asbestos disease victims access to the raw data underpinning the findings of the papers.
The appeal court judges were not impressed, concluding a “crime-fraud” exception applied as Georgia-Pacific “should not be allowed to use its experts’ conclusions as a sword by seeding the scientific literature with GP-funded studies, while at the same time using the privilege as a shield by withholding the underlying raw data that might be prone to scrutiny by the opposing party and that may affect the veracity of its experts’ conclusions.”
Hand over the data
In a 6 June 2013 unanimous decision at the New York Supreme Court Appellate Division,1 the five judges ruled that Georgia-Pacific must allow an in-camera (private) review of documents and raw data related to the eleven published research studies, funded by Georgia-Pacific, concerning the health effects of the company’s asbestos-containing joint compound.
Georgia-Pacific must allow plaintiffs’ law firm Weitz & Luxenberg access to data from the company-backed studies on the health effects of chrysotile asbestos, the judges said, adding: “It cannot be seriously disputed that plaintiffs have a substantial need for the underlying data in the preparation of their cases.”
The appellate court rejected Georgia-Pacific’s argument that the documents were protected by attorney-client privilege, which is sacrosanct in most instances, and should therefore not be disclosed. The judges noted that the crime-fraud exception encompasses “a fraudulent scheme, an alleged breach of fiduciary duty or an accusation of some other wrongful conduct.
“Advice in furtherance of a fraudulent or unlawful goal cannot be considered sound. Rather advice in furtherance of such goals is socially perverse, and the client’s communications seeking such advice are not worthy of protection.”
Hazards asked Professor Donaldson if even he had seen the raw data from the papers to which he was a contributor. He did not respond. He told IBAS, however, his role “was to comment and add to the discussion and general conclusions of the research.” The responses leave it uncertain whether he ever saw, scrutinised or evaluated the raw data on which the discussion and conclusions were based.
Declarations of interest are not afterthoughts; for credible academic journals they are as integral a part of the academic paper production process as identifying the authors. Inhalation Toxicology’s ‘instructions for authors’ require: “All authors must disclose any financial and personal relationships with other people or organisations that could inappropriately influence (bias) their work.”
They add: “It is the sole responsibility of authors to disclose any affiliation with any organisation with a financial interest, direct or indirect, in the subject matter or materials discussed in the manuscript (such as consultancies, employment, paid expert testimony, honoraria, speakers bureaus, retainers, stock options or ownership, patents or patent applications or travel grants) that may affect the conduct or reporting of the work submitted.”
It was an instruction skipped by Donaldson and his co-authors several times over. This serial oversight led Informa Healthcare, the publisher of Inhalation Toxicology, to say it “would like to apologise on behalf of the authors” regarding the four papers from its journal identified by the New York courts, including all those co-authored by Donaldson.
A declaration of interest subsequently added to the four papers noted they “report on work that Georgia-Pacific commissioned to address issues that have arisen in that litigation. I, Stewart E Holm, representing Georgia-Pacific, am an author on all four papers. The other authors are consulting experts retained by or on behalf of Georgia-Pacific to conduct the research and prepare the articles. Dr Donaldson has been listed as potential testifying expert witness by Georgia-Pacific, and Dr Bernstein has testified as an expert witness for Georgia-Pacific.”15
In a 16 August 2013 email to Laurie Kazan Allen of IBAS, Donaldson stated it was apparent the research was not conducted free from the company’s influence, as Holm’s affiliation was given as ‘Georgia-Pacific’. “I think a reasonable person would have known the work was carried out in collaboration with Georgia-Pacific rather than as a grant-funded investigation,” he wrote.
The New York judges took a very different view, saying their crime-fraud exception requiring disclosure of data relating to the studies was justified because of concerns the case involved “a fraudulent scheme, an alleged breach of fiduciary duty or an accusation of some other wrongful conduct.” The court opinion added that the papers to which Donaldson was a co-author failed to make multiple relevant disclosures, including no mention “that Holm was specially employed by GP for the asbestos litigation or that he reported to GP’s in-house counsel.”
Asbestos invoices and paper trails
Other evidence has reinforced the concerns raised by asbestos campaigners about Professor Donaldson’s high profile platform at the international Inhaled Particles XI conference to take place in Nottingham from 23 September 2013.
In June 2013, the California Superior Court also heard evidence of Donaldson’s undeclared links to the GP “asbestos litigation project.” If documents before the court were to be believed, the professor’s relationship with GP was more extensive than suggested in the Inhalation Toxicology declaration and apology.
The shortcomings of the apology were exposed by occupational health researchers David Ozonoff and Philippe Grandjean. Their 27 August 2013 online editorial in the journal Environmental Health titled ‘Transparency and translation of science in a modern world’16 noted: “This carefully worded text still leaves the readers in the dark about who did what and how the company interests affected the research. Perhaps the reviewers and editors were also misled. None of the articles has been retracted.”
It took the court proceedings to cast some light. Court papers, including a letter from Inhalation Toxicology editor Donald Gardner, invoices and correspondence between Professor Donaldson and GP, showed the professor had a long-running working and financial relationship with GP, including direct contact regarding payments with the GP asbestos litigation project coordinator Stewart Holm.
This evidence came to light in exchanges between lawyers for asbestos disease sufferers and Bob Pigg, president of the Asbestos Information Association of North America and a director of the asbestos industry lobbying group the International Chrysotile Association.
In the 18 June 2013 deposition, lawyers cited documents before the court noting: “Co-author Dr Donaldson has also been hired as a consultant – hired by GP as a consultant for the asbestos litigation project on an hourly basis and has been paid from time to time on GP asbestos litigation projects since 2006.”
Court papers showed Donaldson also received at least one payment from David Bernstein for asbestos work [See court exhibit, above right], but it was not specified whether or not this related to work associated with GP. The papers co-authored by Professor Donaldson were published in 2008, 2010 and 2011.
Six of Donaldson’s co-authors - Bernstein, Rogers, Sepulveda, Decker, Gaering and Kuzendorf - received payments from GP totalling $2.3m, the court heard. Holm estimated Donaldson had been paid about $6,000.
Questioned by Hazards about possible payments from Georgia-Pacific, Donaldson said he received no payment for his contribution to the three papers. “I was not paid for this work, which I saw as a contribution to the science of understanding the nature of the chrysotile asbestos dose,” he said. It was an account of his relationship with GP seemingly at odds with evidence and documents presented in the US court cases.
REGISTERING CONCERN An estimated 90 per cent of all asbestos imported to the UK in the 20th century was chrysotile, a substance causing mesothelioma, lung and other cancers. Judges in New York ruled company-financed studies have been used to “cast doubt” on this cancer link.
In 2011, in a deposition at the New York Supreme Court, Holm said a payment of £875 to Donaldson was “probably” for his “review of – and his input into the first biopersistence study paper,” one of the three Donaldson papers included in the alleged crime-fraud.
Donaldson told Hazards: “I had previously written reports for Georgia-Pacific on the hazards of asbestos, as I have done for many other organisations, for which I was paid per report. I was never paid a ‘retainer’ fee by the company, I did not knowingly agree to be a witness in this case and I certainly never provided a deposition,” a claim that in part would appear to be inconsistent with GP’s “Designations of Expert and Fact Witnesses” filed with the New York Supreme Court in 2010 and 2011.
These filings not only listed Professor Donaldson’s name. The most recent said his testimony would be on “concepts of dose, clearance, biopersistence and how the body reacts differently to chrysotile” compared to other forms of asbestos, including that “short fibre chrysotile is not a potent cause of disease in humans and that at low doses, it would not be expected to cause disease at all, including mesothelioma.”
It is possible this series of apparent inconsistencies is the result of confusion, miscommunication or misunderstanding. The professor, anyway, is adamant any possible relationship with the company has no bearing on the views he would express. “In any case, my opinion regarding the pathogenicity of asbestos is the same whether it’s paid for in a consultancy or not,” he told Hazards. The general thrust of the disputed papers and others bearing Donaldson’s name is that the risks of chrysotile have been over-stated and that while it does in some circumstances cause cancer, it can be used safely.
In correspondence with Laurie Kazan Allen of the International Ban Asbestos Secretariat (IBAS), Donaldson noted the papers had been peer-reviewed and “their message is indisputable and is consistent with mainstream scientific opinion regarding the risks from chrysotile. The lack of effect of chrysotile in the studies, which was a moderate exposure along with other particles, followed by use of very sensitive ways of detecting adverse effects, should help reassure individuals who received this sort of exposure.”
It’s not obvious how the professor believes individuals might benefit from this reassurance. It would in almost all circumstances require a chrysotile-exposed person to be already suffering from a usually fatal disease – lung cancer or mesothelioma - to find out via court proceedings their exposure was not, according to the professor’s model, responsible for their condition. If this was accepted by the court, the only assurance they would get was that they would suffer and probably die uncompensated.
The debate over chrysotile is a big deal. It made up around 90 per cent of all the asbestos ever imported to the UK, and for years has been the only form of asbestos still traded – although it has been banned across the European Union for over a decade. With the World Health Organisation (WHO) estimating conservatively that over 100,000 workers are killed by asbestos each year,17 absolving chrysotile of blame for even a small proportion of all the asbestos-related cancer claims would save insurers and companies worldwide billions.
GP values the arguments put in the papers it funded and that were authored by Donaldson and others as it believes they could help it dismiss compensation claims from cancer victims exposed to its asbestos products. If the courts accept the disputed findings of the GP-backed research, many asbestos-exposed cancer sufferers could go uncompensated because they were exposed to the wrong kind of “shorter” chrysotile fibres, were not exposed at high enough levels or, if exposed at a high level, not exposed long enough.
If the professor’s views are “indisputable”, then isolated failures to declare conflicts of interest might have few if any real world consequences. But the three papers appear not to have been Donaldson’s sole failure to reveal potential conflicts and the views expressed may not be quite as universally accepted as the professor suggests.
In a letter published in the International Journal of Occupational and Environmental Health (IJOEH) in 2011, it was not a failure by Donaldson to declare an interest that caused incredulity, but an unequivocal declaration that he had no links to any asbestos interests at all. In the letter, on a page headed ‘Continued controversy on chrysotile biopersistence’18 Professor Donaldson and a co-author stated they were “not allied to any asbestos manufacturing company nor pro-asbestos pressure group, nor in receipt of funds from any such source.”
It was a description of the relationship between Donaldson, who acknowledges being the main author of the letter, and asbestos interests contradicted by hard evidence before the New York and California courts. Invoices indicating the professor had served as a consultant to GP on asbestos issues from at least 2006, had been sent to Stewart Holm [See court exhibit, above right], who headed GP’s asbestos litigation project and provided the direct line to GP’s in-house counsel.
In related March 2006 correspondence with GP’s ‘Asbestos Litigation Law Department’ regarding Donaldson, and copied to GP chief litigation counsel John Childs, Holm referred to “an invoice from our expert in Scotland. He has made a request for payment in pounds" [See court exhibit, right].
In 2010 – the year Donaldson exchanged emails with Bernstein who revised the content of a letter that included Donaldson’s statement that he was free of asbestos-related ties - Donaldson participated in a meeting in London, discussing GP’s asbestos defence with a group including GP’s Stewart Holm and chief litigation counsel, John Childs.
But it wasn’t just a statement from Donaldson intended to establish distance between himself and asbestos interests that alarmed the journal editors. It was the defence of a disputed line on chrysotile ‘biopersistence’ – which forms the crux of the debate about how dangerous this particular form of asbestos is to those inhaling it – that also caused consternation.
The Donaldson letter defended David Bernstein, a long-time consultant for the global asbestos industry, from “unfortunate” criticisms by Henri Pézerat. Pézerat, who died in 2009, had written an article published in IJOEH that year that said Bernstein was guilty of “misuse of biased studies”, producing studies of chrysotile that “lack scientific rigour and credibility” and reaching conclusions that “contradict results obtained by independent scientists”.19
Pézerat noted that the studies by Bernstein and his colleagues “in no way justify the authors’ conclusion… that exposure to chrysotile can only cause cancer if the lungs are subjected to extremely high or prolonged exposure.” The paper concluded: “Bernstein’s results do not constitute scientific progress. Quite to the contrary, they are being misused by the international asbestos producers’ lobby to suggest that chrysotile is harmless. This dangerous assertion particularly compromises the health of workers in developing countries where living and working conditions, combined with inadequate health care, add to the morbidity and mortality resulting from exposure to chrysotile.”
Bernstein’s work was funded by the now-defunct Chrysotile Institute, the Quebec-based asbestos trade group that for many years spearheaded the industry’s global marketing drive. His arguments on biopersistence are central to the asbestos industry’s campaign to rehabilitate chrysotile, something evident from the websites of key asbestos lobby groups like the Thailand-based Chrysotile Information Centre and Russia’s Chrysotile Association, where Bernstein’s work is highlighted.
Drafts of the response co-authored by Donaldson were exchanged with Bernstein for comment, although Bernstein himself did not respond to Pézerat’s charges. Bernstein did though pass the drafts on to Holm at GP.
It is not apparent from the correspondence whether Donaldson was aware that GP had received copies of the drafts; Bernstein’s messages to Holm have been redacted by GP lawyers, the missing text replaced only by the word “Privilege” [See court exhibit, below right].
Bernstein, Donaldson and Holm were together among the co-authors of three of the potential “crime-fraud” papers.
In a response in the same issue, IJOEH editor David Egilman described Donaldson’s claim to be free from links to asbestos interests of any form, financial or otherwise, as “disingenuous at best... Donaldson clearly has a dog in the biopersistence hunt.”
Egilman’s deputy, Susanna Bohme, was more forthright still in a 2012 paper in the journal,20 headed: ‘Expression of concern: false claim to be free of conflicts in asbestos biopersistence debate.’ She noted that since Egilman’s original response, IJOEH “became aware of much more profound conflicts and misrepresentations” on the part of Donaldson and his co-author.
The paper tracked a paper trail of correspondence and court proceedings, papers and filings establishing Donaldson’s links to GP and his involvement of Bernstein, a consultant to the asbestos industry, in revising Donaldson’s IJOEH defence of Bernstein [See court exhibit, right].
Bohme said the “unacknowledged contribution” of Bernstein and the involvement of GP in production of the IJOEH letter violated “the norms of ethical scientific conduct.” She added: “The methodology used in GP’s litigation-driven research was the same or similar to that used in the Bernstein studies criticised by Pézerat, creating a web of connections and mutual interests between Bernstein, Donaldson, and GP that belie Donaldson’s claim to have no conflict of interests in regards to his letter to IJOEH.”
The IJOEH exchanges elicited another apology from Donaldson, who in a 30 August 2011 email to Bohme said: “We see now that there is a link in terms of litigation between Dr Bernstein’s work in general on pure chrysotile exposure and the Georgia-Pacific joint compound issue. If we had realised this at the time we would not have written this letter.” He added he should “have realised the litigational background to our letter. I am now fully aware of it and see that I should have declared these involvements at the time of writing the letter and I fully apologise for the omission.”
Donaldson was invited by IJOEH to respond to Bohme’s expression of concern. He did not respond.
Misconceptions and misuse
It is not just IJOEH or plaintiffs’ lawyers that dispute Professor Donaldson’s “indisputable” views on chrysotile. He has found himself taking issue with two separate United Nations health agencies.
Donaldson criticised the International Agency for Research on Cancer (IARC), as co-author of an April 2007 article accusing the UN agency of “misconceptions and misuse” of cancer classifications. The paper, in the journal Indoor and Built Environment, defended the continued use of chrysotile.21 It noted: “Unfortunately, eliminating substances on the grounds of inherent hazard can deny major benefits to societies and undermine the sustainable developments. This is nowhere better illustrated than in the case of the minerals known collectively as asbestos.”
IARC’s current classification fails to make a distinction between the risks posed by different types of asbestos, the paper said, concluding: “The overwhelming weight of evidence available indicates that chrysotile can be used safely with low risk. Cement products such as water pipes and boards for housing provide are versatile products made at affordable cost for the developing countries which if not available would cost rather than save lives.”
It is an argument that was both seen and heard. The 2007 paper was in September 2013 ranked Indoor and Built Environment’s 13th most cited article. It was also promoted widely by the asbestos trade lobby.22
The June 2007 issue of the newsletter of the Canadian asbestos lobby group, the Chrysotile Institute,23 was similarly impressed by another Donaldson co-production, this time a letter to Margaret Chan, Director General of the World Health Organisation (WHO), raising many of the same concerns spelled out in more detail in the paper criticising IARC and calling for a reconsideration of WHO’s position on the “much less potent” chrysotile.
An editorial in the Chrysotile Institute newsletter, which also included full text of the letter to WHO authored by Donaldson and others as well the abstract of the Indoor and Built Environment paper critical of IARC, spelled out why the industry shared a concern about the UN agencies lack of discrimination on asbestos.
Headed ‘Anti-asbestos group excessively alarmist’, the editorial noted: “There is something very unhealthy in all this. How can we explain that for some people employed by the International Labour Organisation (ILO), the World Health Organisation (WHO), the Rotterdam Convention and even the International Agency for Research on Cancer (IARC), it has become acceptable, even necessary to endorse the position of lobbies for a total ban and to distribute information that is all too often biased and incomplete to support this crusade? There is definitely something to worry about.”
Others believe these agencies have every reason to be wary of the kind of litigation-driven research identified in the crime-fraud case and promoted by the asbestos industry.
Arthur Frank, who holds professorships in medicine and public health at Drexel University in the US, noted: “Outside the courtroom, there is little or no dispute in the medical literature that all asbestos fibre types, including chrysotile, cause asbestosis, lung cancer, and pleural plaques/thickening.” In his 28-page affidavit dated June 2012 he added: “It is my opinion that all forms of asbestos cause mesothelioma, that the fibres of all lengths contribute to the risk of disease, and that existing data is insufficient to quantify any differences in the relative potency in the types of asbestos for causing disease.”
Kathleen Ruff, who coordinated the coalition of health groups opposing asbestos and pressing for the inclusion of chrysotile under the Rotterdam Convention’s ‘prior informed consent’ right-to-know provisions, said she found it “extremely disturbing” that Donaldson and his co-signatories were pursuing a line so similar to that put forward by the asbestos industry.
A biopersistent argument
Professor Donaldson has been an expert witness for both sides in asbestos litigation. When acting for plaintiffs he has endeavoured to “help gain compensation for those who have been negligently exposed,” he told Hazards.“I am certain that asbestos, in all its forms, is a carcinogen… the epidemiology of asbestos-exposed workers is incontrovertible in this regard. I have never denied that asbestos is a carcinogen, quite the opposite.” The professor added: “Because asbestos is a carcinogen I support tight regulation of exposure and am fully aware of the individual pain and suffering asbestos–associated disease causes.”
Firms like GP and the global asbestos lobby have used the chrysotile arguments developed by Bernstein and supported by Donaldson to their own ends, however, including frustrating regulations restricting the use of chrysotile and actively promoting its use. The April 2007 Indoor and Build Environment paper critical of IARC’s “misuse” of cancer classifications, for example, was highlighted on the website of Russia’s Chrysotile Association and those of other industry bodies.
The papers have been central to the asbestos industry’s high profile push to resist the listing of chrysotile asbestos under the Rotterdam Convention’s ‘prior informed consent’ provisions which would not have introduced a ban, just a right to know clause.
Who is David Bernstein?
David Bernstein has been the asbestos industry’s go-to expert for over a decade. His papers and industry-sponsored research have been central to arguments that chrysotile, because it doesn’t linger in the body as long as other types of asbestos, is not so deadly. It forms the platform for the industry’s “safe use” argument.
Bernstein (right) was commissioned by two asbestos trade bodies to develop the chrysotile biopersistence defence in a 2013 paper, Health hazards of chrysotile revisited.24 It concluded: “The importance of the present and other similar reviews is that the studies they report show that low exposures to chrysotile do not present a detectable risk to health. Since total dose over time decides the likelihood of disease occurrence and progression, they also suggest that the risk of an adverse outcome may be low with even high exposures experienced over a short duration.”
The industry hoped the paper would derail attempts to get chrysotile listed at the May 2013 session of the biennial meeting of the Parties to the Rotterdam Convention.25 Chrysotile was not listed.26
The report has also been central to the industry’s strategy to block national bans on chrysotile. When Pakistan in early 2013 considered a ban on asbestos, a letter from the International Chrysotile Association (ICA) directed officials to the ‘Chrysotile revisited’ paper because it was “of paramount relevance to your deliberations”.
The ICA letter said it showed “the scientific evidence is overwhelming which supports the safe and responsible use of chrysotile.” The claims were condemned in a response from 143 prominent scientists from 30 countries.27 ICA, which was created in the UK in 1976 under the name ‘Asbestos International Association’ but is now based in Quebec, did not reveal to the Pakistani officials that it had co-financed Bernstein’s paper.
By any standards, the industry-driven campaign to rehabilitate chrysotile has been a success. Regulations at the national and international levels have been resisted. And the long term decline in global asbestos consumption has been arrested, steadying at about 2 million tonnes annually since the late-1990s. In 2012, asbestos exports increased by 20 per cent on the 2011 figure, from 1,081,885 tons in 2011 to 1,327,592 tons in 2012.28
Canadian human rights campaigner Kathleen Ruff, who headed the unsuccessful campaign to get chrysotile listed at the 2013 Rotterdam Convention meeting, is dismayed. The convention’s ‘prior informed consent’ provisions would have stopped exporting nations off-loading chrysotile without first informing the importer of the cancer risks associated with the product.
She puts the continuing trade in asbestos down to an industry public relations strategy based around industry-backed research where, as in the potential crime-fraud case, the researchers failed to declare their financial or other links to the industry.
“The asbestos industry thus succeeded in halting the precipitous drop in its sales and, for the past twenty years, has maintained production at around two million tons a year. The world production figure for 2012 is estimated at 1,987,800 metric tons. The figure for 2011 was 2,034,700 metric tons,” noted Ruff. “Of the 2,034,700 tons mined in 2011, the industry exported 1,081,885 tons to other countries.”
Ruff described the behaviour of Donaldson as “reprehensible,” noting that papers like the IARC criticism that claimed restrictions on the availability of chrysotile asbestos products would cost rather than save lives, “puts forward the propaganda of the asbestos industry and this propaganda is rejected by reputable scientists.”
She added: “If Professor Donaldson wishes to promote the use of chrysotile asbestos, he should do so in the UK, where at least there are health and safety regulations to protect the health of workers and citizens – regulations that are virtually non-existent in developing countries, such as India, China and Vietnam, where chrysotile asbestos is being used today.”
Laurie Kazan Allen of IBAS said the issue was one that asbestos disease victims could not escape. “The court’s findings are of great concern not only to US asbestos plaintiffs and their representatives but also to people in the UK suffering from asbestos-related diseases,” she told Donaldson by letter.
As the controversy continues, questions about Professor’s Donaldson’s high profile involvement in BOHS’ September 2013 conference have been raised, questions ducked by BOHS. BOHS president, David O’Malley, told Hazards by email “it is not appropriate for BOHS either to comment on on-going legal matters to which it is not a party or to engage with them or to pre-judge hypothetically their outcome.” He refused to comment on whether the professor’s reputation was tarnished by the court and other revelations.
However, he did tell Laurie Kazan Allen that Donaldson’s involvement in Inhaled Particles XI was “fitting”, adding: “It is BOHS’ view that at present there is no reason why Professor Donaldson should not continue as Chair of the IPXI Scientific Committee, and present his keynote at the event.”
Kathleen Ruff believes BOHS should drop Professor Donaldson from its event, and says there are in fact a good number of reasons to justify this. She told Hazards it was “improper and unethical” that he failed to reveal he was receiving funds from GP, saying the professor should be held responsible for “misrepresenting, as an independent scientific paper, articles that were co-written by an employee of Georgia-Pacific who was under the control and direction of the corporation’s litigation department.”
Laurie Kazan Allen said she found Donaldson’s links to the potential crime-fraud “troubling”, concerns that had not been allayed by clarifications provided by the professor and BOHS. “That the ties of a corporate asbestos defendant (GP) with authors of a scientific text have led to allegations of a potential 'crime-fraud,' in my opinion, throws into question the fairness and transparency of the judicial process,” she told Hazards.
Professor Donaldson reaches a different conclusion. He told Hazards: “I have nothing to hide and I welcome the fact that the court will see all of the relevant papers concerning the studies. I hope that this review will show that the science was robust. However, science progresses by revision and improvement and if there are aspects of the work that could be improved then I am sure these can be addressed with further investigation.”
Asked by Hazards if he accepted the potential “crime-fraud” criticism by the courts, Professor Donaldson did not respond. Questioned about the extent of the involvement of GP and its lawyers in the production of the papers to which he contributed, the professor had nothing to say.
1 Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, No. 9535, 2013 WL 2435565 (N.Y. App. Div., 1st Dep’t June 6, 2013).
2 D Bernstein, K Donaldson, U Decker, S Gaering, P Kunzendorf, J Chevalier and SE Holm, A Biopersistence Study following Exposure to Chrysotile Asbestos Alone or in Combination with Fine Particles,Inhalation Toxicology, volume 20, number 11, pages 1009-1028, 2008.
3 D Bernstein, RA Rogers, R Sepulveda, K Donaldson, D Schuler, S Gaering, P Kunsendorf, J Chevalier and SE Holm, The Pathological Response and Fate in the Lung and Pleura of Chrysotile in Combination with Fine Particles Compared to Amosite Asbestos Following Short-Term Inhalation Exposure: Interim Results, Inhalation Toxicology, volume 22, number 11, pages 937-962, 2010.
4 D Bernstein, RA Rogers, R Sepulveda, K Donaldson, D Schuler, S Gaering, P Kunzendorf, J Chevalier and SE Holm, Quantification of the Pathological Response and Fate in the Lung and Pleura of Chrysotile in Combination with Fine Particles Compared to Amosite-Asbestos Following Short-Term Inhalation Exposure, Inhalation Toxicology, volume 23, number 7, pages 372-391, 2011.
5 Brorby, Sheehan, Berman, Greene and Holm. Re-Creation of Historical Chrysotile-Containing Joint Compounds, Inhalation Toxicology, volume 20, pages 1043-1053, 2008.
6 Brorby, Sheehan, Berman, Bogen and Holm. Potential Artifacts Associated with Historical Preparation of Joint Compound Samples and Reported Airborne Asbestos Concentrations, J. Occup. and Environ. Hyg., volume 8, pages 271-278, 2011.
7 Sheehan, Brorby, Berman, Bogen and Holm. Chamber for Testing Asbestos-Containing Products: Validation and Testing of a Re-Created Chrysotile-Containing Joint Compound, Ann. Occup. Hyg., volume 55, number 7, 797- 809, 2011.
8 Simmons, Jones and Boelter. Factors Influencing Dust Exposure: Finishing Activities in Drywall Construction, J. Occup. and Environ. Hyg., volume 8, pages 324-336, 2011.
9 Jones, Simmons and Boelter, Development and Evaluation of a Semi-Empirical Two Zone Dust Exposure Model for a Dusty Construction Trade, J. Occup. and Environ. Hyg., volume 8, pages 337-348, 2011.
10 Jones, Simmons and Boelter. Comparing Two-Zone Models of Dust Exposure. J. Occup. and Environ. Hyg., volume 8, pages 513-519, 2011)
11 Berman, Brorby, Sheehan, Bogen and Holm. More on the Dynamics of Dust Generation: The Effects of Mixing and Sanding Chrysotile, Calcium Carbonate, and Other Components on the Characteristics of Joint-Compound Dusts, Ann. Occup. Hyg., volume 56, number 7, pages 852-867, 2012.
12 Brorby, Sheehan, Berman, Bogen and Holm. Exposures from Chrysotile-Containing Joint Compound: Evaluation of New Model Relating Respirable Dust to Fiber Concentrations, Volume 33, Issue 1, pages 161–176, January 2013.
13 P Borm and Flemming R Casse. Ken Donaldson: retirement of a young mind, Particle and Fibre Toxicology, volume 10, number 8, 2013.
14 JW Cherrie, LM Brosseau, A Hay and K Donaldson. Low-toxicity dusts: Current exposure guidelines are not sufficiently protective, Annals of Occupational Hygiene, volume 57, issue 6, pages 685-691, 2013.
15 Corrigendum. Informa Healthcare. Undated.
16 P Grandjean and D Ozonoff. Transparency and translation of science in a modern world, Environmental Health, volume 12, number 70, 27 August 2013
17 Asbestos: elimination of asbestos-related diseases, Factsheet N°343, WHO, July 2010.
18 K Donaldson, G Oberdorster. Continued controversy on chrysotile biopersistence, IJOEH, volume 17, number 1, pages 98-99, 2011; discussion pages 99-102.
19 H Pézerat. Chrysotile biopersistence: the misuse of biased studies, IJOEH, volume 15, number 2, pages 102-6, 2009.
21 David Bernstein, Allen Gibbs Fred Pooley, Arthur Langer, Ken Donaldson, John Hoskins, Jacques Dunnigan. Misconceptions and Misuse of International Agency for Research on Cancer ‘Classification of Carcinogenic Substances', Indoor and Built Environment, volume 16, number 2, pages 94-98, April 2007.
22 Version of the ‘Misconceptions and misuse’ article above on the Russian Chrysotile Association website.
23 Chrysotile Institute newsletter, volume 6, number 2, June 2007, including letter from David Bernstein, Ken Donaldson and others to Margaret Chan, director general WHO, 27 February 2007.
24 D Bernstein and others. Health hazards of chrysotile revisited, Critical Reviews in Toxicology, volume 43, number 2, pages 154-183, 2013.
25 Rotterdam Convention brochure, International Chrysotile Association, 2013.
26 Rotterdam Convention in crisis, RightonCanada website, 10 May 2013.
27 International Statement condemns asbestos industry interference to prevent a proposed ban on asbestos in Pakistan, RightonCanada website, 22 February 2013.
28 Kathleen Ruff. Global asbestos trade increased by more than 20 per cent in 2012, Prevent Cancer Now, 1 July 2013.
Questions and answers
Below are the questions put by Hazards editor Rory O’Neill to Professor Donaldson on 30 August 2013, and answers received from Professor Donaldson by email on 2 September 2013.
Hazards Do you accept the potential “crime-fraud” criticism of the appellate court of papers including those to which you were a co-author?
Donaldson No response.
Hazards This statement was issued by Inhalation Toxicology: “The publisher would like to apologise on behalf of the authors of the following 4 articles published in Inhalation Toxicology,” three of which you co-authored. Why did you apologise, via the publisher, and for what?
Donaldson No response.
Hazards Was Georgia-Pacific involved in any way in the papers to which you were a co-author, for example the design of the studies and discussion of content of drafts and the final text? Was this involvement, if it occurred, made clear?
Donaldson No response.
Hazards You note the publications stated the research was “sponsored by a grant” from Georgia-Pacific? Is this the whole story? Wasn’t the work of at least some of the contributors paid for on a consultancy or retainer basis, something revealed by court depositions made under oath?
Donaldson No response.
Hazards Some critics have described publicly the 11 papers as “counterfeit science” and “planted misinformation”. What is your response to this?
Donaldson I have nothing to hide and I welcome the fact that the court will see all of the relevant papers concerning the studies. I hope that this review will show that the science was robust. However, science progresses by revision and improvement and if there are aspects of the work that could be improved then I am sure these can be addressed with further investigation.
Hazards You note in correspondence with IBAS that you were not paid for your involvement in the named papers. The statement from Stewart Holm forming part of the Inhalation Toxicology apology noted “other authors are consulting experts retained by or on behalf of Georgia-Pacific to conduct the research and prepare the articles. Dr. Donaldson has been listed as potential testifying expert witness by Georgia-Pacific..” I’d like to offer you the opportunity to clarify precisely what if any financial arrangements you have or had agreed with the defendant/Georgia-Pacific and/or legal and other agents acting on its behalf. Did you or an institution/organisation receiving funds on your behalf receive payment related to the case in question, either from Georgia-Pacific, their legal advisers or others acting on their behalf? If so, for what, how much and when?
Donaldson On the specifics of the 3 papers discussed in the Georgia Pacific case, you should know that I was not paid for this work, which I saw as a contribution to the science of understanding the nature of the chrysotile asbestos dose.
Hazards Was your “potential testifying expert witness” role to be remunerated, and if so what remuneration were you to receive should you appear?
Donaldson I was never paid a ‘retainer’ fee by the company, I did not knowingly agree to be a witness in this case and I certainly never provided a deposition. In any case, my opinion regarding the pathogenicity of asbestos is the same whether it’s paid for in a consultancy or not.
Hazards Have you undertaken other asbestos-related consultation for Georgia-Pacific, its lawyers or other agents acting on its behalf unrelated to this court case? If so, when, for what and was it remunerated? I note court depositions made under oath say you have been paid in relation to the Georgia-Pacific case; I would like to clarify what work these payments, if they occurred, related to.
Donaldson I had previously written reports for Georgia Pacific on the hazards of asbestos, as I have done for many other organisations, for which I was paid per report.
Hazards In correspondence with IBAS you note that the message of the papers “is indisputable and is consistent with mainstream scientific opinion”. With this in mind, can you explain why you have found your arguments at odds with those expressed by both IARC (Indoor and Built Environment April 2007 vol. 16 no. 2 94-98) and the World Health Organisation (Letter to Margaret Chan, 27 February 2007)?
Donaldson No response.
Hazards Further to the previous question, if your message is “indisputable” why was this message disputed in an exchange in the International Journal of Occupational and Environmental Health (IJOEH), culminating in a 2011 exchange of letters between you (and a co-author) and IJOEH editor David Egilman (Donaldson K, Oberdorster G. Continued controversy on chrysotile biopersistence, vol.17, Jan/March 2011 and same issue reply from David Egilman)?
Donaldson No response.
Hazards Do you accept those papers identified by the court and to which you were a co-author were potentially part of a “crime fraud”, defined for legal purposes as “a fraudulent scheme, an alleged breach of fiduciary duty or an accusation of some other wrongful conduct”?
Donaldson No response.
Hazards Did you a) see; and b) scrutinise raw data used in the three papers to ascertain that these data supported the arguments put forward in the paper? Did you satisfy yourself that this is the case?
Donaldson No response.
Hazards Do you accept the co-exposures investigated in the papers to which you are a contributor do not reflect the exposures and risks faced by many of the workers in the Georgia-Pacific cases subject to litigation, and so are misleading?
Donaldson No response.
Hazards Are there any other points you would like to raise?
Professor Donaldson provided this preamble to the responses above:
“I first need to clarify that I am certain that asbestos, in all its forms, is a carcinogen. I published papers early in my career demonstrating that both amphiboles and chysotile cause cancer and fibrosis in rats after inhalation ( For example J. M. Davis, S. T. Beckett, R. E. Bolton, and K. Donaldson The effects of intermittent high asbestos exposure (peak dose levels) on the lungs of rats. Br J Exp Pathol. 1980 June; 61(3): 272–280.; Davis JM, Beckett ST, Bolton RE, Donaldson K. A comparison of the pathological effects in rats of the UICC reference samples of amosite and chrysotile with those of amosite and chrysotile collected from the factory environment. IARC Sci Publ. 1980;(30):285-92.). In addition, the epidemiology of asbestos-exposed workers is incontrovertible in this regard. I have never denied that asbestos is a carcinogen, quite the opposite.
“Because asbestos is a carcinogen I support tight regulation of exposure and am fully aware of the individual pain and suffering asbestos–associated disease causes. I carry out expert witness work and have provided opinion in many cases on the side of asbestos plaintiffs. Commonly the plaintiff has mesothelioma and I am asked whether their occupational history supports the contention that it was asbestos-induced. Invariably there is an occupational history of asbestos exposure and I can provide an opinion to support the contention that the asbestos caused the cancer. In these instances I hope that my independent scientific evaluation can support the court process and help gain compensation for those who have been negligently exposed.”
|•||The Donaldson file|
|•||The Holm front|
|•||Hand over the data|
|•||Asbestos invoices and paper trails|
|•||Misconceptions and misuse|
|•||A biopersistent argument|
|•||Who is David Bernstein?|
|•||Questions and answers|
Spin Cycle Product defence: How industry money protects killer chemicals. Hazards 103