Putting IARC Under the Microscope
A Review of Nathan Schachtman’s Critique of the Beleaguered Cancer Research Agency
Last month, a monograph entitled IARC’s Precautionary Science: How the WHO Cancer Research Agency Misinforms Regulation and Litigation was published. The author, Nathan Schachtman, counsel to UB Greensfelder and Columbia law professor, roundly criticizes the state of the cancer agency’s monograph classification process. He sets out in a clear structure how the WHO’s International Agency for Research on Cancer (IARC) has created a process that misleads regulators, courts and the media on the presence and risk of potential carcinogens.
Schachtman begins with a history of how IARC’s emergence in the 1970s coincided with the massive increase in environmental health regulatory agencies, the use of the precautionary principle within many of these agencies, and the environmental NGO movement. Scientific papers also evolved around this period, at a time when literature reviews were still not considered as legitimate research contributions. It does not take much to add the elephant in the room, that from these evolutions, the US litigation industry has, since then, grown into the Hydratic monster it is today.
With IARC’s Precautionary Science, Nathan Schachtman meticulously details everything that has gone wrong with IARC, its use of precaution and the corruption of scientific evidence used in the US litigation industry. With Nathan’s clear biting style and borderline satire, perfected in his must-read website, Tortini, it becomes evident how far from science and evidence the international cancer agency has strayed. Every line echoes my thoughts ... a book I wish I had written.
Precaution is not science
Schachtman’s focus is to demonstrate how IARC, likely due to its ties to the Collegium Ramazzini ideology, has taken a precaution-driven approach to carcinogen classifications.
“The precautionary principle diverges dramatically from the U.S. legal system in which persons claiming to have been harmed must prove, among other things, the harmful nature of the defendants’ conduct or products, by a preponderance of evidence. The precautionary principle also diverges from science, where scientific claims are established with ample evidence after severe testing.”
Regulators may choose to take precaution, but that is a policy decision, not a scientific one. IARC, in taking a precautionary approach, is not forthcoming in its political interests and strategies. A good part of Schachtman’s work seeks to shine a light on how the precautionary bias manifests itself in their classification distortions, abuse of the risk-hazard distinction, and their checklist approach.
Hazard and Risk
Schachtman identified IARC’s ongoing ambivalence toward its role in merely providing hazard assessments (the initial step in the risk assessment process). Given IARC’s outdated prestige assumption, they seem to expect environmental health agencies to automatically adopt their monograph hazard classifications into national regulations. But in saying a substance is a hazard does not mean much on its own. Risk assessors need to consider if the exposure to these hazards is relevant and if risk-reduction measures can mitigate the threats.
“In IARC parlance, cancer risk requires a finding that an agent is a cancer hazard, that it can cause cancer, but identifying a cancer hazard without more information does not equate to any cancer risk. The assessment and quantification of cancer risk typically requires that we know the route of exposure, the actual conditions under which the agent is used, the level of exposure, peak exposure, and cumulative exposure to humans, the metabolic fate and distribution of the agent in humans, and toxico-kinetics of the agent (rate at which the agent is metabolized or cleared from the human body), the exposure-outcome gradient, and the existence of thresholds of exposure for any risk. The IARC classifications provide little to no information about the sorts of data needed to determine and characterize risk. To the uninformed public and media, hazard sounds a lot like risk, and the two concepts would naturally be confused.”
On their own then, hazard assessments are not very useful. Schachtman rifles off a series of IARC hazard classifications of substances they had classified as carcinogenic that are also produced naturally in the human body like formaldehyde, ethylene oxide, testosterone… “Encapsulating people or putting warning signs on people’s faces will not really help prevent cancer.” IARC’s hazard-based precautionary approach is “devoid of scientific meaning” and the contradictions in IARC’s monographs, from coffee to red meat to crystalline silica (sand), render them practically useless. Unless you are an opportunistic tort lawyer.
Schachtman cites a term I believe he coined to describe one of IARC’s cottage industries: tortogenesis.
“Although IARC’s classification of a carcinogen cannot inform us whether specific exposure circumstances increase risks of cancer, the classification can and does result in ‘tortogenesis’. IARC classifications have been known to spark mass tort claims in the United States, and elsewhere. Careless expert witnesses have been known to misrepresent IARC hazard classifications as risk determinations.”
This is the beauty of Schachtman’s thinking and resultant prose. Tortogenesis is the act of initiating and promoting events that lead to mass tort lawsuits. IARC’s reclassification of glyphosate leading to hundreds of thousands of lawsuits is a prime example of tortogenesis. The cancer agency has spawned a new breed of scientist who is ‘tortogenetic’ by nature, producing research that is jury-ready. At that point in the book, I was on the edge of my seat as Schachtman brought me into the bosom of the Collegium Ramazzini - the place where tortogenesis was suckled.
The Ramazzini Ideology
Schachtman shows how IARC and the US tort industry were interconnected with Collegium Ramazzini fellows, and how their ideology of using research to prosecute industry and to promote precautionary regulations was exploited.
“In science, as in the law, the burden of showing that an agent is carcinogenic resides with those claiming causation. The precautionary principle, sometimes subtly, more often overtly, shifts the burden to those claiming non-carcinogenicity. The Collegium and its members are committed to the precautionary principle, which poses a major ideological conflict of interest when its members publish, testify, or participate in the IARC monograph process. The list of the Collegium’s American fellows reads like a Who’s Who of expert witnesses for the lawsuit industry. ... Many of the Collegium fellows have had important roles in the IARC program.”
Almost without fail, all of the scientists Nathan charged with having hidden their conflicts of interest were Collegium Ramazzini fellows.
I have covered the Ramazzini campaigns far too often, describing it as a private club for politically driven activist scientists. Ramazzini science is weak, with like-minded fellows peer reviewing each other’s papers to be published in their own journals. Schachtman hones in on the unscientific precautionary ideology at the core of the Collegium but he could have expanded on their volumes of poor methodology, non-transparent funding (like the Russian involvement) and hidden conflicts of interest.
If I may make a minor criticism though. Of the 16 scientists Schachtman cites as actively working within the Ramazzini – IARC – litigation industry nexus, I was surprised that he had missed Philip Landrigan, long-time head of the Ramazzini scientific board and litigation industry entrepreneur. And a chapter on Linda Birnbaum, the Ramazzini bank clerk, would not have been deemed inappropriate. But this can be overlooked as there are just too many conflicted researchers in this activist scientist pantomime.
Ten Key Characteristics
In several recent articles on IARC, I had been struggling with how the cancer agency’s recent conception of the Ten Key Characteristics (KCs) of Carcinogens could be considered as scientific. Nathan’s chapter on the Ten KCs assured me that they are most definitely not scientific.
“The group touted its identification of KCs as a way of organizing and understanding carcinogenesis, but they also advocated using KCs to predict carcinogenesis in the face of insufficient epidemiology and even insufficient animal evidence. The KCs working group was dominated by members of the Collegium Ramazzini and like-minded scientists who seemed frustrated with the inability to identify more carcinogens, more rapidly.”
Schachtman cited several cases where IARC then intentionally revisited past monographs using their newfound key characteristics to “upgrade classifications” to higher levels of carcinogenicity (noting how the lawsuit industry has found this “check the boxes” approach very opportunistic). I should add that my investigation into how IARC revisited its talc monograph a third time (solely to deliver a more litigation-friendly conclusion with the key characteristic strategy) came out while this book was in the publication process. Nathan’s conclusions more than confirmed the suspicions in my exposé.
Schachtman’s Recommendations
As much as Schachtman condemns IARC for its broken monograph methodologies, conflicts of interest, precautionary, Ramazzini bias … he makes many valuable recommendations that might be useful in rehabilitating the cancer agency, namely:
Stop pretending that the monographs are part of a consensus process and open the deliberations to a wider range of views. “If IARC were to adopt this approach, and engage with adversarial points of view, it might have fewer consensus monographs, but more credible conclusions in the end.”
Be transparent and root out all conflicts of interest. “While complaining about “vested interests,” IARC’s leadership and many of its working group members have special interests because of their membership in the Collegium Ramazzini. Many of the Collegium’s membership work in service of the American lawsuit industry as consultants or testifying expert witnesses. Given the ideological and positional conflicts of interest rife throughout IARC, it should be opening its deliberative process to inspection, not trying to shame stakeholders into silence.”
Peer review the monographs. “The myriad systematic reviews published each year in higher quality journals undergo peer review of varying quality. IARC, however, remains steadfast in rejecting external review of its monographs before publication.” Schachtman though wonders if IARC monographs will ever be able to reach the same quality of the systematic reviews now available in the scientific literature.
But in the end, given the political bias, conflicts of interest, undue prestige and secretive process, Nathan feels that reform of IARC’s monograph program is futile. “When we add to these considerations, the redundancy, inaccuracy, and unscientific nature of IARC classifications, the simplest solution is to abandon the entire enterprise of IARC hazard classifications.”
Cynically, Schachtman concludes that IARC has achieved one thing.
“The IARC classification process clearly is a known litogen and tortogen, with a clear ability to create personal injury and environmental litigation. The lawsuit industry, made up of lawyers who pursue such litigation, along with their litigation lenders and funders, and aligned with environmental advocacy groups constitute a loud and persistent, rent-seeking, support group for the IARC classification process, with its precautionary principle leanings.”
In six lines, Nathan summed up the Predatort Playbook, something that took me a decade to figure out.
As a fellow writer on the need to protect scientific evidence from the onslaught of special interests unleashed within the IARC – Ramazzini – litigation industry nexus, I find Nathan Schachtman’s meticulous book extremely valuable. While his chronologies and timelines are precise, in reading his case study of the glyphosate fiasco, I couldn’t help but wonder if his research had been published a decade earlier, how different the world would have been.
Schachtman’s “IARC’s Precautionary Science” provides the teaching; we need to demonstrate the learning.