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In glyphosate review, WHO cancer agency edited out 'non-carcinogenic'
findings
https://www.reuters.com/article/us-who-iarc-glyphosate-specialreport/in-glyphosate-review-who-cancer-agency-edited-out-non-carcinogenic-findings-idUSKBN1CO251?utm_source=CCNet%20Newsletter&utm_campaign=2777977dca-EMAIL_CAMPAIGN_2017_10_20&utm_medium

October 19, 2017 / 10:38 AM / 6 months ago
In glyphosate review, WHO cancer agency edited out 'non-carcinogenic'
findings

LONDON (Reuters) - The World Health Organization’s cancer agency dismissed
and edited findings from a draft of its review of the weedkiller glyphosate
that were at odds with its final conclusion that the chemical probably
causes cancer.

Documents seen by Reuters show how a draft of a key section of the
International Agency for Research on Cancer’s (IARC) assessment of
glyphosate - a report that has prompted international disputes and
multi-million-dollar lawsuits - underwent significant changes and deletions
before the report was finalised and made public.

IARC, based in Lyon, France, wields huge influence as a semi-autonomous
unit of the WHO, the United Nations health agency. It issued a report on
its assessment of glyphosate - a key ingredient in Monsanto Corp’s
top-selling weedkiller RoundUp - in March 2015. It ranked glyphosate a
Group 2a carcinogen, a substance that probably causes cancer in people.

That conclusion was based on its experts’ view that there was “sufficient
evidence” glyphosate causes cancer in animals and “limited evidence” it can
do so in humans. The Group 2a classification has prompted mass litigation
in the United States against Monsanto and could lead to a ban on glyphosate
sales across the European Union from the start of next year.

The edits identified by Reuters occurred in the chapter of IARC’s review
focusing on animal studies. This chapter was important in IARC’s assessment
of glyphosate, since it was in animal studies that IARC decided there was
“sufficient” evidence of carcinogenicity.

One effect of the changes to the draft, reviewed by Reuters in a comparison
with the published report, was the removal of multiple scientists’
conclusions that their studies had found no link between glyphosate and
cancer in laboratory animals.

In one instance, a fresh statistical analysis was inserted - effectively
reversing the original finding of a study being reviewed by IARC.

In another, a sentence in the draft referenced a pathology report ordered
by experts at the U.S. Environmental Protection Agency. It noted the report
“firmly” and “unanimously” agreed that the “compound” – glyphosate – had
not caused abnormal growths in the mice being studied. In the final
published IARC monograph, this sentence had been deleted.

Reuters found 10 significant changes that were made between the draft
chapter on animal studies and the published version of IARC’s glyphosate
assessment. In each case, a negative conclusion about glyphosate leading to
tumors was either deleted or replaced with a neutral or positive one.
Reuters was unable to determine who made the changes.

IARC did not respond to questions about the alterations. It said the draft
was “confidential” and “deliberative in nature.” After Reuters asked about
the changes, the agency posted a statement on its website advising the
scientists who participate in its working groups “not to feel pressured to
discuss their deliberations” outside the confines of IARC.

Reuters contacted 16 scientists who served in the IARC expert working group
that conducted the weedkiller review to ask them about the edits and
deletions. Most did not respond; five said they could not answer questions
about the draft; none was willing or able to say who made the changes, or
why or when they were made.

The chairman of the IARC sub-group tasked with reviewing evidence of
glyphosate’s effect on laboratory animals was Charles Jameson, an American
toxicologist. In testimony as part of personal-injury lawsuits against
Monsanto in the United States, Jameson told lawyers for Monsanto he did not
know when, why or by whom the edits had been made.

Monsanto is facing multiple legal claims in the U.S. from plaintiffs who
allege glyphosate gave them or their loved ones cancer. Jameson is an
expert witness for the plaintiffs. He did not respond to questions for this
article.

Scott Partridge, Monsanto’s vice president of global strategy, told Reuters
the changes to the draft showed how “IARC members manipulated and distorted
scientific data” in their glyphosate assessment.

IARC declined to comment.

Numerous national and international agencies have reviewed glyphosate. IARC
is the only one to have declared the substance a probable carcinogen.
Compared with other agencies, IARC has divulged little about its review
process. Until now, it has been nearly impossible to see details, such as
draft documents, of how IARC arrived at its decision.
FILE PHOTO: External view of the International Agency for Research on
Cancer (IARC) in Lyon, France, June 12, 2017. To match Special Report
WHO-IARC/GLYPHOSATE REUTERS/Robert Pratta/File Photo

The European Food Safety Authority (EFSA) said that in its assessment of
the weedkiller, the scientific decision-making process “can be traced from
start to finish.” Jose Tarazona, head of EFSA’s pesticides unit, told
Reuters: “Anyone can go to EFSA’s website and review how the assessment
evolved over time. So you can see clearly how experts … appraised each and
every study and also how comments from the public consultation were
incorporated into the scientific thinking.”

In the United States, the Environmental Protection Agency published a full
1,261-page transcript of a three-day scientific advisory panel meeting on
its ongoing evaluation of the carcinogenic potential of glyphosate in
December 2016.

No such record of the deliberations behind IARC’s monographs is published.

In a previous response to questions about the transparency of the IARC
process, the agency’s director, Chris Wild, referred Reuters to a letter in
which he said his agency’s assessments are “widely respected for their
scientific rigor, standardized and transparent process.” Wild also said
IARC’s methods are intended to allow scientists to engage in free
scientific debate at its monograph meetings.
DELETIONS AND ADDITIONS

IARC says its working group scientists are selected for “their expertise
and the absence of real or apparent conflicts of interest.” For the panel
that evaluated glyphosate and four other pesticides in what is known as
IARC’s Monograph 112, scientists from 11 countries met at the agency’s
headquarters in Lyon for a week-long meeting starting on March 3, 2015. The
meeting “followed nearly a year of review and preparation” by IARC staff
and working group members, “including a comprehensive review of the latest
available scientific evidence,” IARC said in a statement at the time.

In June, Reuters reported how the chairman of the IARC working group was
aware of new data showing no link between glyphosate and cancer in humans,
but the agency did not take it into account because it had not been
published.

No drafts of IARC’s glyphosate assessment have surfaced before. However, a
draft was obtained by Monsanto as part of the legal proceedings in the
United States. Reuters reviewed chapter 3, the section on animal studies,
which is the only section no longer covered by a confidentiality order of
the court.

The glyphosate review in IARC’s Monograph 112 runs to 92 pages; the chapter
on animal studies consists of just over 10 pages. Reuters has not seen any
other sections of the draft and cannot say whether they also underwent
significant edits.

In comparing draft and final versions of chapter 3, Reuters found that in
several instances comments in the draft were removed; the comments noted
that studies had concluded glyphosate was not carcinogenic. They were
replaced in the final version with the sentence: “The Working Group was not
able to evaluate this study because of the limited experimental data
provided in the review article and supplemental information.”

This sentence was inserted six times into the final version. Each time it
replaced a contrary conclusion, noted in the draft, by the original
investigators on the study being considered, such as: “The authors
concluded that glyphosate was not carcinogenic in Sprague Dawley rats”;
“The authors concluded that glyphosate technical acid was not carcinogenic
in Wistar rats”; and “The authors concluded that glyphosate was not
carcinogenic in CD-1 mice in this study.”

Reuters also found changes to the conclusions and statistical significance
of two mouse studies. These studies were cited in IARC’s ultimate finding
of “sufficient” evidence that glyphosate causes cancer in animals.

One edit concerned a 1983 study in mice. IARC’s published monograph
contains a fresh statistical analysis calculation as part of its review of
that study. The original investigators found no statistically significant
link between glyphosate and cancer in the mice. IARC’s new calculation
reached the opposite conclusion, attributing statistical significance to
it.

This new calculation was inserted into the final published assessment, but
was not in the draft version seen by Reuters. The change gave the working
group more evidence on which to base its conclusion that glyphosate was
probably carcinogenic.

In further discussion of the same 1983 study, IARC’s final published report
refers to expert pathologists on a panel commissioned to reanalyze the work
of the original investigators. The IARC draft notes that these pathologists
“unanimously” agreed with the original investigators that glyphosate was
not related to potentially precancerous tissue growths in the mice. IARC’s
final report deletes that sentence.

Reviewing a second mouse study, the IARC draft included a comment saying
the incidence of a type of animal cancer known as haemangiosarcoma was “not
significant” in both males and females. IARC’s published monograph, by
contrast, inserts a fresh statistical analysis calculation on the data in
male mice, and concludes that the findings were statistically significant.
INFLUENTIAL MONOGRAPH

IARC’s assessment that glyphosate is a probable human carcinogen is an
outlier. In the 40 or so years since the weedkiller first came to the
market, glyphosate has been repeatedly scrutinized and judged safe to use.
Slideshow (4 Images)

A year after IARC issued its evaluation, a joint United Nations and World
Health Organization panel reviewed the potential for glyphosate in food to
cause cancer in people. It concluded the weedkiller was “unlikely to pose a
carcinogenic risk to humans.”

The U.S. Environmental Protection Agency, which first assessed glyphosate
in the 1980s and has reviewed it several times since, says it has “low
toxicity for humans.” The European Food Safety Authority and the European
Chemicals Agency, which advise the 28 members of the EU, have also assessed
glyphosate within the past two years and ruled it safe.

But IARC’s Monograph 112 has had great influence.

It is weighing heavily on a pending European Union decision – due by the
end of the year and possibly to be made next week - on whether glyphosate
should be relicensed for sale across the 28 member states. France, one of
the bloc’s agricultural powerhouses, has said it wants the weedkiller
phased out and then banned, provoking protests by its vocal farmers, who
argue glyphosate is vital to their business.

A failure to renew glyphosate’s license by the end of the year would see an
EU ban kick in on Jan. 1, 2018.

In the United States, Monsanto – the firm that first developed and marketed
glyphosate - is facing litigation in California involving at least 184
individual plaintiffs who cite the IARC assessment and claim exposure to
RoundUp gave them a form of cancer known as non-Hodgkin lymphoma. They
allege Monsanto failed to warn consumers of the risks. Monsanto denies the
allegations. The case is ongoing.

Members of the U.S. Congress, concerned about what they described as IARC’s
“inconsistent” standards and determinations for classifying substances as
carcinogenic, last year launched investigations into American taxpayer
funding of IARC. The investigations are ongoing.

In Europe, IARC has become embroiled in a public spat with experts at the
European Food Safety Authority, which conducted its own review of
glyphosate in November 2015 and found it “unlikely to pose a carcinogenic
hazard to humans.”

With IARC monograph meetings, some outside observers are selected and
allowed to witness proceedings, but they are banned from talking about what
goes on. Journalists are generally not allowed in.

Last year, Reuters reported on an email sent by IARC to the experts on its
glyphosate working group in which the agency advised them not to discuss
their work or disclose documents. The email said IARC “does not encourage
participants to retain working drafts or documents after the monograph has
been published.”

Reuters sent questions about the draft version of the glyphosate assessment
to members of the IARC working group that assessed the herbicide as well as
to the head of IARC’s monograph program, Kurt Straif, and to Kathryn (Kate)
Guyton, the staffer responsible for the glyphosate review. IARC responded
by posting the following message on its website:

“Members of the IARC Monograph Working Group which evaluated glyphosate in
March 2015 have expressed concern after being approached by various parties
asking them to justify scientific positions in draft documents produced
during the Monographs process. IARC would like to reiterate that draft
versions of the Monographs are deliberative in nature and confidential.
Scientists should not feel pressured to discuss their deliberations outside
this particular forum.”

IARC answered none of Reuters’ specific questions about changes to the
draft.

By Kate Kelland. Editing By Richard Woods
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