<figure><img src="image_1.png" /></figure>

HAL
open science

# Lobbying through science. Discussing epistemic capture in the case of ILSI and the mode of action (MOA) of chemicals

David Demortain

► To cite this version:

David Demortain. Lobbying through science. Discussing epistemic capture in the case of ILSI and the mode of action (MOA) of chemicals. Corporate Capture and the Environmental Emergency, Paris School of Economics, Mar 2024, Paris, France. [https://hal.science/hal-04532174v1](https://hal.science/hal-04532174v1)

HAL Id: hal-04532174

https://hal.science/hal-04532174v1

Submitted on 23 Jan 2025

HAL is a multi-disciplinary open access
archive for the deposit and dissemination of sci-
entific research documents, whether they are pub-
lished or not. The documents may come from
teaching and research institutions in France or
abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est
destinée au dépôt et à la diffusion de documents
scientifiques de niveau recherche, publiés ou non,
émanant des établissements d'enseignement et de
recherche français ou étrangers, des laboratoires
publics ou privés.

Public Domain
## Lobbying through science

Discussing epistemic capture in the area of chemicals regulation: ILSI and the "mode of action" regulatory concept

David Demortain

INRAE Research professor — Laboratoire Interdisciplinaire Sciences Innovations Sociétés (LISIS)

LISIS

INRAE

## Lobbying through science?

* The corporate political activity consisting in the enrolment of academic scientists and experts, to influence regulatory frameworks and norms applying to businesses
## Corporate playbook regarding science

* Hiding selected science

* Funding/defunding research centers and universities

* Decredibilizing scientists in the public sphere

* Hiring scientists for product defence

* Ghost-writing

* Producing doubt and shifting the attention of publics to alternate issues

* ...

## ... and: creating or using 'front groups'

Creating a dedicated organization, with the appearance of a neutral, objective provider of knowledge, to alter the credibility of opponents, promote defensive messages, create or reframe controversies...

* Examples include:

* American Industrial Health Council

* American Council on Science and Health

* International Life Science Institute

* Health and Environmental Safety Institute

* European Centre for Ecotoxicology and Toxicology of Chemicals
Three questions

* How do firms operate through such front groups and what do they achieve by lobbying through science?

* Does this qualify as capture — if not regulatory capture, can we speak of cultural or 'epistemic' capture?

* Are public policies and regulations to address the environmental crisis delayed or altogether halted, as a result of capture?

CAPTURE
## From regulatory capture...

* Where regulators end up acting in the interest of regulated industries (Bernstein 1955).

* Picked up by political scientists, historians, and others, who criticized the notion:

* An interest based reading, but interests not easy to identify and contrast

* Opposes public and private entities, instead of looking in a more fine-grained manner at the interactions between actors in a regulatory space

* Not easy to identify or measure (Carpenter & Moss 2013)

## To cultural capture

* Carpenter and Moss 2013: « There are arguments about the cultural or social influence of repeated interaction with the regulated industry, such that the regulator begins to think like the regulated and cannot easily conceive another way of approaching its problems. »

* Contrasts with regulatory capture:

* Knowledge-rather than interest-based view: the fact that reg and reg think alike

* Derives from repeated, fluid interactions within the span of the networks that structure a regulatory sector

* Diagnosed looking 'upstream' from regulatory outcomes, how regulatory frameworks are shaped
Or epistemic capture

* A situation whereby a way of knowing and addressing a regulatory problem, is shaped by concepts, methods or metrics that can be traced to regulated firms, and that tend to generate favourable regulatory outcomes when applied

ILSI & regulatory concepts for chemicals

* Operational ideas regarding how to qualify health and safety problems, based on an implicit vision of what is risky, and predefines regulatory decisions

* Examples: « acceptable daily intake », « margin of exposure », « benchmark dose », « threshold of toxicological concern » or « mode of action »...

* All exist as ideas first, and end up informing regulatory practice
ILSI

ILSI

* A non-profit, charitable (hence tax-exempted) organization created in 1978 by Coca-Cola Vice-Pdt, in the wake of the caffeine toxicity controversy

* Since the 1980s, a global organization: European branch established in 1986, alongside other regional branches
Abbott Nutrition

ADM

Almomoto

Arte Foods

Banco D&R Fratelli

BASF GE

Caesars Health

Cargill

Chri. Hansen

Casuari Groupe Waring

Danone

Dew Europe

DSM

DuPont Nutrition & Health
Fermentich
Frisland Campina
General Mills
Givaudan International

Indoor Biotechnologies

Institut Merieux

Johnson & Johnson EAME

Kabuli Frosenius

Kod Corporation

Lorillard

Mars

Mayo-Medical Kmart

Mead Johnson Nutrition

Merrill

Mondelis International

Lorillard

Lucozade Ribena Suntory

Luligi Lavazza

Mars

Mayo-Medical Kmart

Mead Johnson Nutrition

Merrill

Merrill

Mandrelle International

Manzana Europe

Nestlé

Nestlé

Nexira

Onyx International

PepsiCo International

Pfizer Consumer

Healthcare

Pierre Fabre Dermo-Cosmetique

PPG Industries

Premier Foods

Procter & Gamble

Red Bull

Red Bull

Roquette

Sanofi-Aventis Group

Schweppes Group

Seneva

SOM Europe

Sodexo Europe

Sodexo Group

Swiss Quality Testing
Services - SQTS

Syngenta

Tata & Lyte

Terexos

Tetra Pak

The Coca-Cola Company

The Vossler Corporation

Ting SA R&D

Uker Biokom

Unilever

WALA-Hallmattel

Yakult Europe

Yuli Innovation Center
Europe

Yukuit Europe

Yuli Innovation Center
Europe

ILSI 40320

03-62W090-29-6220-U 006209 IN189/3930

1/31/2012 THE PEW CHARITABLE TRUSTS

20,000.00

ILSI 40320

03-629980-29-6230-70 006473 IN18976513

9/30/2012 ILLINOIS INSTITUTE OF TECHNOLO

17,000.00

ILSI 40320

03-629980-29-6230-70 006490 IN18976200

11/30/2012 THE PEW CHARITABLE TRUSTS

25,000.00

ILSI 40320

01-641500-72-8410-30 006431 IN18975520

8/31/2012 KELLOGG COMPANY

10,000.00

ILSI 40320

01-641500-72-8410-30 006450 ACHD8/16

8/18/2012 MARS, INC

7,667.00

ILSI 40320

01-641500-72-8410-30 006527 IN18976473

12/31/2012 AJINOMOTO CO

10,000.00

ILSI 40320

01-641500-72-8410-30 006527 IN18976473

12/31/2012 CROPLIFE INTERNATIONAL AISBL

17,500.00

1,543,560.00

ILSI 40320

01-686112-70-8600-40 006543 IN18981213

TB:

ILSI 198,187.00

RF 2,215,774.00

Total 2,411,041.00

Asia/Pacific-North 12,000.00

Europe & Africa 36,000.00

HESI/NA 817,381.90

NA 201,000.00

Outside Individual 1,545,560.00

Grand Total 1,411,541.90

Count 888,381.90

Doesn't Count - Outside 1,545,560.00

Total 1,411,541.90
A vessel for direct lobbying of authorities

* One example: Top ILSI people maintained close links with officials of the CDC, and how those links were used to help articulate and deploy the strategies of Coca-Cola to counter the actions of the WHO on sweeteners (USRTK 2016a)

Are industry-funded charities promoting "advocacy-
led studies" or "evidence-based science"?: a case
study of the International Life Sciences Institute

Sarah Steele ID, Gary Ruskin, Leila Sarcevic, Martin McKee & David Stuckler

Globalization and Health 15, Article number: 36 (2019) | Cite this article

<figure><img src="image_2.png" /></figure>

<figure><img src="image_3.png" /></figure>

Researchers have labelled the International Life Sciences Institute an industry front group, after studying thousands of documents, @SarahSteeleIL, after @martinmckee @davidstuckler @garyruskin

<figure><img src="image_4.png" /></figure>

ILSI Response to Globalization and Health

6 June 2019 | edited? November 2019

On June 3, 2019 Dr. Sarah Steele, Department of Politics and International Studies, University of Cambridge, and colleagues published an article in Globalization and Health titled "Are industry-funded charities promoting "advocacy-led studies" or "evidence-based science"?: a case study of the International Life Sciences Institute." Subsequently, many international media outlets have reported on this paper.

Dr. Steele's article concludes that "ILSI seeks to influence individuals, positions, and policy, both nationally and internationally, and its corporate members deploy it as a tool to promote their interests globally." The organization's characterization of ILSI's activities is misleading. ILSI's long-standing position on tobacco is well as recent changes in ILSI's governance.

Key Points

* ILSI is a nonprofit, worldwide organization whose mission is to provide science that improves human health and well-being and to advance the environment. ILSI and ILSI entities, former public, private scientific partnerships, to address knowledge gaps to benefit public health.

* ILSI does not lobby, nor does ILSI seek to influence individuals, positions, and/or specific policies. Additionally, ILSI explicitly
## Networking to shape reg thinking

« We don't lobby”

<figure><img src="image_5.png" /></figure>

<figure><img src="image_6.png" /></figure>

## Modus operandi

* Task forces pick up ideas from firms and associated scientists, of methods that can address – or even preempt – concerns of regulators (e.g. are chemicals positive in animal tests also dangerous for humans?)

* Creates a working group, and invite a broad set of scientists and regulators, to further articulate and give credibility to the concept

* Disseminate the concept systematically through repeated publications, reports, and in meetings with regulators, to get these to apply the concepts
Why do

* Science-like objectivity that reduces uncertainty

* Consensus that is repeatedly agreed upon

* Standard: around the same

* Links with

<figure><img src="image_7.png" /></figure>

ical
 protocols
t, hence

s that

agencies

or diluted

Network of
institutions to
which co-authors
of ILSI papers are
affiliated

<figure><img src="image_8.png" /></figure>

Analysis and visualization performed with Context Manager
Discreet but central

* ILSI does not appear as an author, sometimes not even as an affiliation of the authors of the paper.

* « ILSI Europe has already published 12 scientific peer-reviewed publications this year. If we were to consider ILSI Europe as an individual scientist, our h-index would be 82.»

MOA
Quick definition

* The mode of action of a chemical is the biological mechanism, described at the cellular level, by which it is presumed to cause toxicity in a given organ ('endpoint')

A toxicological paradigm

* First occurrences in the literature starting in the 1960s by the rare new university toxicology centers (e.g. Chicago, J. Doull)

* A paradigm that has unfolded and taken various conceptual forms over time:

* « Mechanism » first

* « modes of action » second

* « toxicity pathways » (NRC 2007)(short-lived) third

* And « adverse outcome pathway »
## Mechanistic toxicology before ILSI

* Articulated in the 1960s in sites of gov-acad-industry collaboration (BIBRA in UK, CIIT in the US)

<figure><img src="image_9.png" /></figure>

Instead, in 1961 Golberg became the founding Director of the British Industrial Biological Research Association (BIBRA) in London. This new organization, a joint industry-government effort, was created to investigate mechanisms underlying toxic effects of chemicals, develop new or improved toxicity tests, and give advice and information on toxicological issues. BIBRA was intended to be an impartial forum for improved communication between industry, government, and academic personnel in addressing toxicological issues of major public significance, issues that were emerging with increasing frequency and contentiousness.

## Industry interest in mechanistic knowledge

* Crystallizes in the 1980s in the US, judging from scientific publications and from industry's internal correspondence

* Working on mechanisms and modes of action= a way out of the regulatory controversies surrounding high-profile substances, and the threshold/no-threshold controversy, that animal tests do not help decide

* Takes form in R&D organization and programs in the 1990s, both in the US and in Europe
## MOA research as product defence

* Firms also realized that MOA can invalidate positive results in animal tests: if you can prove the cellular mechanism does not exist in humans, positive results in animal tests may be disregarded: the 'relevance' issue

* "The original mechanistic research was asking the question what's caused these effects and would we see these effects in humans? And some of them you say, you know, if humans were exposed at the same doses, you'd get the same response and therefore that would lead to cancer, and some you wouldn't. So that was the first sort of investigative toxicology that was done."

## ILSI working group: (ex)EPAers and acad.

<figure><img src="image_10.png" /></figure>
Funding of research on MOAs with no
human relevance

> *Toxicol Sci.* 2006 Jan;89(1):51-6. doi: 10.1093/toxsci/kfj001. Epub 2005 Oct 12.

Mode of action in relevance of rodent liver tumors to
human cancer risk

Michael P Holsapple ¹, Henri C Pitot, Samuel M Cohen, Alan R Boobis, James E Klaunig, Timothy Pastoor, Vicki L Dellarco, Yvonne P Dragan

Enrollment of the WHO's IPCS

<figure><img src="image_11.png" /></figure>

ELSEVIER

Regulatory Toxicology and Pharmacology
Volume 34, Issue 2, October 2001, Pages 148-152

<figure><img src="image_12.png" /></figure>

Regular Article

IPCS Conceptual Framework for Evaluating a
Mode of Action for Chemical Carcinogenesis

C. Sonich-Mullin<sup>6</sup>, R. Fielder<sup>6</sup>, J. Wiltse<sup>5</sup>, K. Boetcke<sup>4</sup>, J. Dempsey<sup>6</sup>, P. Fenner-Crisp<sup>5</sup>, D. Gront<sup>1</sup>

M. Hartley<sup>1</sup>, A. Knoep<sup>5</sup>, D. Kroese<sup>9,2</sup>, J. Mangelsdorf<sup>6</sup>, E. Meek<sup>1</sup>, J.M. Rice<sup>1</sup>, M. Younes<sup>1</sup>
## Enrollment of other reg entities, through ILSI.eu and allied platforms

An ECETOC/ILSI RF/HESI workshop was held in 2009 to exchange views on conceptual approaches to the use of Mode of Action (MOA) in chemical risk assessment. A number of recommendations emerged, and a global Steering Group was convened by WHO/IPCS to co-ordinate implementation of an ‘umbrella plan’ of work, comprising experts from ECHA, EFSA, Imperial College, JRC, OECD, University of Ottawa, US EPA, ILSI/HESI, and ECETOC. The objectives of the 2013 workshop were to review progress that had been made since 2009. Specifically, these were to share experiences in applying the MOA approach in the regulatory

## New publication based on ILSI.eu work

Review

> Crit Rev Toxicol. 2011 Mar;41(3):175-86. doi: 10.3109/10408444.2010.541225.

Using mode of action information to improve regulatory decision-making: an ECETOC/ILSI RF/HESI workshop overview

Neil Carmichael¹, Melanie Bausen, Alan R Boobis, Samuel M Cohen, Michelle Embry, Claudia Fruijtier-Pélooth, Helmut Greim, Richard Lewis, M E Bette Meek, Howard Mellor, Carolyn Vickers, John Doe
Co-authorship networks in the field of MOA research

<figure><img src="image_13.png" /></figure>

Co-authorship networks in the field of MOA research

<figure><img src="image_14.png" /></figure>
Relevance questions in EU reg processes

<figure><img src="image_15.png" /></figure>

However, even if further investigation would allow the definite conclusion that the mode of
action of fluopyram was very similar to PB, this would not mean that classification and
labeling of fluopyram for carcinogenicity would not be warranted. In fact, the notifier referred
to papers in which the receptor CAR has been shown to be less important than the PXR
receptor for CYP induction in human liver (Moore et al., 2003, ASB2008-5463) and a PB-like
mode of action is considered to be non-relevant to humans (Holapple et al., 2006,
ASB2008-2132). However, molecular effects of PB are not limited to induction of CAR but
also include interaction with Cx32 containing gap junctions (Moennikes et al., 2000,
ASB2009-918), activation of protein phosphatases (e.g. Pastlynyak et al., 2006, ASB2009-
920) and effects caused by HGF dependent signaling (Santoni-Rugiu et al., 1996, ASB2009-
921; Magxo-Stoelting et al., 2008, ASB2009-922). Furthermore, PB is still considered a class
2B carcinogen by the IARC (Anonym, 2001, ASB2008-5447), also due to epidemiological
findings summarized by Whyser et al. (1996, ASB2008-5446). PB is consequently labeled
R40 when sold as a chemical (Sigma Aldrich, 2005, ASB2009-924, SDS Phenobarbital).
Accordingly, a substance that is shown to be like PB would require the same labeling in terms
of tumor induction.

No mechanical benefit of MOA but...

* The effects of establishing a framework of thinking in terms of MOA and relevance, and investing in research in this area involve:

* Raising the threshold of proof required to establish the existence of a toxicity in humans, and so delays or annuls risk assessments

• Helping manufacture uncertainty around established mechanisms

* Ascertaining the animal-only nature of certain mechanisms
## Conclusion

* On science? Embracing the language of objectivity and evidence (replicable protocols, 'further research is needed', evidence, use of peer communities) appears decisive

* Capture? Clear strategy of diffuse intervention through the fabric of the regulatory space, with limited attributability of concepts - and of benefits.

* Environmental crisis? ILSI's concepts strengthen the focus of the reg framework on *individual chemicals*, and on the ascertaining of chemical-to-effect relationship > as much attention and time divested from measuring and acting on the overall chemical burden on populations and the biosphere.

Many thanks for your attention!

<figure><img src="image_16.png" /></figure>