Glyphosat und Krebs: Gekaufte Wissenschaft - Die Tricks von Monsanto und der Beitrag der Behörden, um Glyphosat vor einem Verbot zu retten - Bund ...
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Glyphosat und Krebs: Gekaufte Wissenschaft Die Tricks von Monsanto und der Beitrag der Behörden, um Glyphosat vor einem Verbot zu retten.
Glyphosat und Krebs:
Gekaufte Wissenschaft
Die Tricks von Monsanto
und der Beitrag der Behörden,
um Glyphosat vor einem
Verbot zu retten.
Pesticide Action Network
Germany
Von Helmut Burtscher- Auch unterstützt durch:
Schaden PhD, Peter Clausing
PhD, and Claire Robinson campact
MPhil
März ���� Bund für Umwelt und Natur-
schutz Deutschland (BUND) –
Herausgeber: Friends of the Earth Germany
AVAAZ
GLOBAL ����
Friends of the Earth Austria
Neustiftgasse ��
���� Vienna, Austria
www.global����.at GMWatch (UK)
Corporate Europe Observatory
GMWATCH
Pesticide Action Network
© ���� Helmut Burtscher- Europe
Schaden, Peter Clausing und Umweltinstitut Müchen e.V.
Claire Robinson
Korrespondenzautor:
Helmut Burtscher-Schaden,
helmut.burtscher@global����.at
Gekaufte
mals verpflichtend fest, dass der einzureichende
Zulassungsantrag (Dossier) auch die Publikati-
Wissenschaft
onen aus der frei zugänglichen wissenschaftli-
chen Literatur der letzten �� Jahre enthalten
muss. In der Vergangenheit basierte die be-
hördliche Bewertung und Zulassung von Pesti-
Die Tricks von Monsanto und der Beitrag zidwirkstoffen auf den Studien der Hersteller.
der Behörden, um Glyphosat vor einem Diese betrachten ihre Studien als Eigentum
und Geschäftsgeheimnis und verhindern so die
Verbot zu retten. Begutachtung durch unabhängige Wissen-
schaftler.
Der Report zeigt, wie die seit ���� geltende
EU-Pestizidverordnung ����/���� den Fort- Die geheimen Herstellerstudien gelangen re-
bestand der europäischen Zulassung von Gly- gelmäßig zur Schlussfolgerung, dass Glyphosat
phosat bedrohte, und mit welchen Mitteln für die vorgesehenen Zwecke sicher eingesetzt
und Strategien Monsanto und andere Glypho- werden kann. So behaupten fast alle Industrie-
sat-Hersteller darum kämpfen, ihr Herbizid vor studien einheitlich, dass Glyphosat nicht geno-
dem drohenden Verbot zu retten. toxisch sei, also keine Schäden der Erbsubstanz
verursache. Doch die Mehrzahl der unabhängi-
Kapitel � beschreibt die neuen Herausforde- gen Studien berichtet Schädigungen der Erb-
rungen, mit denen die Hersteller von Glyphosat- substanz. Würden die europäischen Behörden
haltigen Herbiziden konfrontiert waren, als sie diesen unabhängigen Studien gleich viel Ver-
���� die Wiedergenehmigung ihres Wirkstoffs trauen schenken wie den Studien der Glypho-
in Europa beantragten. Gemäß der seit ���� sat-Hersteller, dann wäre eine Verlängerung
geltenden EU-Pestizidverordnung ����/���� der europäischen Genehmigung ernsthaft in
dürfen Pestizidwirkstoffe wie Glyphosat nicht Gefahr.
mehr vermarktet werden, wenn sie u.a. die Fä-
higkeit haben, Krebs hervorzurufen oder das Auf diese Herausforderung reagierten
Erbgut zu schädigen. Dies ist der sogenannte Monsanto und andere Hersteller mit der Be-
“gefahrenbasierte Ansatz“. Ein Pestizid mit sol- auftragung und Finanzierung einer Vielzahl
chen Eigenschaften darf nicht genehmigt wer- wissenschaftlicher Übersichtsartikel in der frei
den. Entscheidend ist die inhärente Stoffeigen- zugänglichen Literatur. Alle diese Artikel kom-
schaft der Chemikalie und nicht das (oftmals men zu der Schlussfolgerung, dass Glyphosat
schwer kalkulierbare) Risiko für den Menschen und seine kommerziellen Präparate keine Ge-
unter bestimmten Expositionsszenarien. Die fahr für die Gesundheit darstellen.
Argumentation, dass bei sachgemäßer Anwen-
dung die Menschen nur “sicheren“ Konzentra- Brisante Einblicke in die strategischen Über-
tionen des betreffenden Pestizids ausgesetzt legungen und Motive der Glyphosat-Hersteller
wären – der “risikobasierte Ansatz“ – ist für geben E-Mails von Monsanto, die kürzlich in
solche Stoffe nicht zulässig. Alle EU-Gremien Zusammenhang mit einem Gerichtsverfahren
unterstützten mit Verabschiedung der Pestizid- in den USA an die Öffentlichkeit gelangt sind:
verordnung dieses Gefahrenkonzept, mit dem In diesen E-Mails diskutieren Monsanto-Wis-
Ziel, generell die Exposition von Menschen und senschaftler über die Option, dass Monsanto
der Umwelt gegenüber diesen besonders ge- für diese Übersichtsartikel als Ghostwriter fun-
fährlichen Substanzen – und ihrer Gemische - giert und bekannte Wissenschaftler wie Helmut
zu reduzieren. Greim, oder David Kirkland die Manuskripte nur
noch editieren und unterschreiben brauchen.
Diese Gesetzesänderung konfrontiert Mons- Auch die Sorge der Glyphosat-Hersteller, ihre
anto und andere Hersteller von Glyphosat mit Behauptung Glyphosat wäre nicht genotoxisch
einem ernsten Problem: Ihre Krebsstudien zei- könnte angesichts der zahlreichen gegenteili-
gen vor allem bei Mäusen durchwegs statistisch gen Berichte in der publizierten wissenschaft-
signifikante und dosisabhängige Krebseffekte lichen Literatur unglaubwürdig sein, findet in
bei den mit Glyphosat behandelten Tieren. den E-Mails Ausdruck und führt zum Engage-
ment des unabhängigen Spezialisten David
Zudem legt die neue Pestizidverordnung erst- Kirkland. Seine Übersichtsarbeit, die er ����
Zusammenfassung 3 | Glyphosat und Krebs, Gekaufte Wissenschaftgemeinsam mit dem ehemaligen Monsanto- sogenannten „Weight of Evidence Approach“
Mitarbeiter Larry Kier publizierte, gab nach ei- vorgenommen zu haben – also eine gewichtete
ner “gewichteten Betrachtung“ der vorliegen- Wertung der Beweise für eine mögliche Karz-
den veröffentlichten wissenschaftlichen Studien inogenität von Glyphosat. Doch in Wirklichkeit
und unveröffentlichten Hersteller-Studien hin- haben sie diese gewichtete Bewertung dezi-
sichtlich der Genotoxizität von Glyphosat Ent- diert vermieden.
warnung. Diese Arbeit floss in das europäische
und in das US-amerikanische Zulassungsver- Ein „Weight of Evidence Approach“ setzt eine
fahren ein, und bot den dortigen Behörden ganzheitliche Betrachtung der verschiedenen
Argumente, um positive Befunde für die Ge- Beweislinien voraus, nämlich die von:
notoxizität von Glyphosat aus der publizierten
Literatur serienweise als Zufallsergebnisse oder • Tierversuchen,
Artefakte zu verwerfen.
• epidemiologischen Daten,
Im März ���� wurde Monsanto schwer ge-
troffen, als die Krebsagentur der Weltgesund- • möglichen Mechanismen für die
heitsorganisation (IARC) bekannt gab, dass sie Entstehung von Krebs.
Glyphosat als “wahrscheinlich krebserregend
für den Menschen“ einstuft und dass es starke Im Fall von Glyphosat ergänzen die verschie-
Beweise für seine Gentoxizität gäbe. Glypho- denen Beweislinien einander. Der wiederholt
satprodukte sind ein lukratives Geschäft, deren signifikante Anstieg von Lymphdrüsenkrebs
Umsatz im Jahr ���� vermutlich die �� Milliar- im Mausexperiment passt zu der in epidemio-
den-Dollar-Grenze überschreiten würde. Die logischen Studien festgestellten Häufung von
Industrie hat demnach erhebliches Interesse Lymphdrüsenkrebs (Non Hodgkin Lymphom)
eine Strategie zu entwickeln, diese Chemikalie bei Menschen, die Glyphosat anwenden. Das
am Markt zu halten. Ganze wird von überzeugenden Belegen für
Genotoxizität und oxidativen Stress als mög-
Monsantos geballte Antwort auf die WHO- liche zugrunde liegende Mechanismen unter-
Krebseinstufung kam im Herbst ���� in Form stützt.
einer Serie von Übersichtsartikeln in den Critical
Reviews in Toxicology, im Folgenden “Intertek Insgesamt gibt es Beweise in allen drei zu be-
Papers“ genannt, nach dem von Monsanto zwi- rücksichtigenden Bereichen. Eine ganzheitliche
schengeschalteten, gleichnamigen Beratungs- Betrachtung dieser Beweislage führt unum-
unternehmen. Die Autoren gehörten einem Gly- gänglich zu der Schlussfolgerung, dass Glypho-
phosat-Expertengremium an, das von Intertek sat krebserregend ist.
einberufen wurde.
Doch anstatt entsprechend vorzugehen, be-
Das erklärte Ziel der Intertek Papers ist die trachten die Monsanto-finanzierten Autoren
Entkräftung der Glyphosat-Bewertung durch die verschiedenen Beweislinien getrennt von-
die IARC. Sie kommen einhellig zu dem Schluss, einander, benutzen falsche Argumente, ver-
dass Glyphosat beim Menschen weder das Erb- schweigen oder verdrehen Fakten und behaup-
gut schädigt noch Krebs auslöst. ten zugleich, dass dies ihre Schlussfolgerungen
untermauern würde.
Doch unsere Analyse in Kapitel � offenbart,
dass diese Publikationen mit schweren Män- Eine für die Geschichte von Glyphosat sehr
geln behaftet sind und einer kritischen wissen- entscheidende Episode, die in den Intertek
schaftlichen Prüfung nicht standhalten. Insbe- Papers erwähnt aber nicht objektiv berichtet
sondere zählen dazu Manipulationen wie das wird, ereignete sich im Jahr ����, als die US-
mutmaßlich gezielte Weglassen von relevan- EPA (Umweltbehörde der USA) Glyphosat erst-
ten Daten bei gleichzeitiger Präsentation irre- mals als “möglicherweise krebserregend beim
levanter Daten, mit deren Hilfe Sachverhalte Menschen“ einstufte. Das Urteil der EPA basier-
verzerrt, Leser in die Irre geführt und wissen- te auf der signifikanten und dosisabhängigen
schaftlichen Beweise verneint werden. Zunahme eines seltenen Nierentumors in ei-
ner von Monsanto beauftragten Mäusestudie.
Vor allem aber behaupten die Autoren, einen Doch ein “externer Pathologe“ namens Marvin
Zusammenfassung 4 | Glyphosat und Krebs, Gekaufte WissenschaftKuschner, bewertete kurz nach der Krebsein- ums konnte kein Interessenkonflikt außer ihrer
stufung durch die EPA die Daten erneut und Mitarbeit an den Intertek Papers festgestellt
behauptete, einen solch seltenen Nierentumor werden.
auch bei einer Kontroll-Maus (ein Tier, das kein
Glyphosat erhielt) gefunden zu haben (Recher- Kapitel � beschreibt die fundamentalen wissen-
chen zufolge war Marvin Kuschner Mitglied schaftlichen Schwächen der Krebsbewertung
von Monsantos Biohazard-Kommission). Sollte durch das BfR (Bundesinstitut für Risikobewer-
sich dieser Fund bestätigen, würde die statis- tung), der EFSA (Europäische Lebensmittelbe-
tische Signifikanz der für Monsanto so proble- hörde) und des CARC (Cancer Assessment Re-
matischen Studie knapp über die üblicherweise view Committee) der US-Umweltbehörde EPA
tolerierte Irrtumswahrscheinlichkeit von �% und kritisiert die fehlende Nachvollziehbarkeit
“rutschen“. Der Tumor Befund der Mäusestu- der Schlussfolgerungen des JMPR (Joint FAO /
die gälte dann als nicht mehr signifikant und WHO Meeting on Pesticide Residues).
Glyphosat wäre auf dem Papier vom Verdacht,
Krebs zu verursachen, befreit. Die Feststellung der Glyphosat-Hersteller und
der von diesen beauftragten Wissenschaftler,
Doch die von der US-EPA beauftragten Pa- dass ihr Pestizid nicht krebserregend ist, wird
thologen konnten den vermeintlichen Tumor durch die Urteile von mehreren regulatori-
in der unbehandelten Maus nicht finden und schen Behörden und Expertengremien unter-
bestätigen. Nicht in den ursprünglichen Nieren- stützt. Dazu zählen das BfR, die EFSA, die US-
schnitten und auch nicht in einer Serie neu an- EPA und das JMPR der FAO/WHO. Doch auch
gefertigter Gewebeschnitte derselben konser- deren Bewertungen der Krebsgefahr werden
vierten Organe. Allerdings erklärten mehrere durch schwere wissenschaftliche Mängel beein-
von Monsanto konsultierte Berater, dass sie in trächtigt und letztlich entwertet. Ein Beispiel:
der Lage waren, Kuschners zusätzlichen Tumor Nachdem die Krebsforschungsagentur IARC
zu erkennen und zu bestätigen. Nach langem in den selben vier Hersteller-Studien (je zwei
Hin und Her anerkannte die EPA ���� den an- Krebsstudien mit Ratten und Mäusen) “ausrei-
geblichen Tumor in der Kontrollmaus und revi- chende Beweise für eine krebserregende Wir-
dierte ihre Krebseinstufung von Glyphosat. kung“ von Glyphosat fand, in denen zuvor das
BfR “keine Hinweise für eine Krebswirkung“
Kapitel � widmet sich den Interessenkon- erkennen konnte, erhielt die deutsche Behör-
flikten jener Autoren, die hinter den Intertek de den Auftrag, die Bewertungen der IARC zu
Papers und anderen industrie-finanzierten evaluieren. In der Folge musste das BfR die von
Übersichtsartikeln stehen, welche konsequent der IARC festgestellten statistisch signifikanten
schlussfolgern, dass Glyphosat beim Menschen Tumorbefunde in allen vier Studien bestäti-
weder krebserregend noch erbgutschädigend gen. Auch in den übrigen drei Mausstudien der
sei. Hersteller musste die Behörde statistisch sig-
nifikante und dosisabhängige Zunahmen von
Abgesehen von der Beauftragung durch Tumoren zugeben, die sie vorher anscheinend
Monsanto, haben viele Autoren darüber hi- “übersehen“ hatte. Als Erklärung für diese ko-
nausgehende Interessenkonflikte mit der lossale Fehlleistung räumte die Behörde ein, sie
Chemie- und Pestizidindustrie. Zwölf der �� habe “ursprünglich auf die mit den Studien der
Mitglieder des Gremiums waren bereits als Be- Hersteller mitgelieferten statistischen Auswer-
rater für Mon-santo tätig oder bei dem Unter- tungen vertraut“.
nehmen angestellt. Viele der Autoren pflegen
oder pflegten Verbindungen zum industrie- Besondere Brisanz erhält dieses Versagen der
nahen “International Life Sciences Institute“ deutschen Behörde durch den Umstand, dass
(ILSI), einer Organisation, die unter anderem der gefahrenbasierte Ansatz in der EU-Pestizid-
von Unternehmen finanziert wird, die Glypho- verordung die Zulassung eines Wirkstoffes un-
satprodukte herstellen und/oder vermarkten, tersagt, sobald positive Krebsbefunde in min-
einschließlich Monsanto, Dow und BASF. Die- destens zwei Tierstudien vorliegen.
se Interessenkonflikte wurden gegenüber der
Öffentlichkeit und den Medien oftmals nicht Auffallend ist auch die wiederholte und irre-
deklariert. Nur bei einem Mitglied des Gremi- führende Vermischung der Begriffe Gefahr und
Zusammenfassung 5 | Glyphosat und Krebs, Gekaufte WissenschaftRisiko durch das BfR (und teilweise auch durch gestehen. Insbesondere bei Fragen von hohem
die EFSA). Die Vermutung drängt sich auf, dass politischen und ökonomischen Gewicht, und
dies in der Absicht geschieht vom gefahrenba- möglicherweise gravierenden Auswirkungen
sierten Ansatz abzulenken und damit von den auf die Gesundheit von Menschen.
eindeutigen Konsequenzen positiver Krebsbe-
funde bei Mäusen und Ratten für die Pestizid- In anderen Fällen hatten Personen, die in die-
zulassung laut EU-Gesetz. sen Institutionen arbeiteten, offenkundig Inte-
ressenkonflikte mit der Industrie. Zum Beispiel
Ähnlich wie die von Monsanto bezahlten Wis- war Alan Boobis, der Vorsitzende des JMPR
senschaftler, gibt auch das BfR in seiner Krebs- für Glyphosat, auch der Vizepräsident von ILSI
bewertung vor, einen “Weight of Evidence Europe. Bemerkenswerter Weise erhielt in je-
Approach” zu verfolgen, und macht schließlich nem Jahr, als Monsanto den Antrag auf eine
das genaue Gegenteil. Die Behörde entflechtet EU-Zulassung einreichte, ILSI eine sechsstellige
zuerst die drei Beweisstränge (Evidenz beim Spende von Monsanto und anderen Herstellern
Menschen, beim Tier, und für Mechanismus), von Glyphosat. Der stellvertretende Vorsitzen-
zerlegt sie in einem weiteren Schritt in ihre de des JMPR, Professor Angelo Moretto, war
Einzelteile, und verwirft die derart isolierten Vorstandsmitglied des ILSI Health and Environ-
Beweise letztlich einen nach dem anderen als mental Sciences Institute (HESI) und des dazu
singuläres Zufallsergebnis. gehörigen Risk�� Lenkungsausschusses. Der
stellvertretende Vorsitzende von letzterem war
Auch die Krebsbewertung der US-EPA, durch wiederum Alan Boobis.
das Cancer Assessment Review Committee
(CARC) ist von gravierenden wissenschaftlichen Jess Rowlands, der Mann der als Vorsitzen-
Mängeln geprägt. Das CARC hat mehrfach ent- der des CARC, für dessen fehlerhafte Krebsbe-
gegen den wissenschaftlichen Belegen und un- wertung verantwortlich zeichnet und zwi-
ter Verletzung der geltenden Empfehlungen schenzeitlich im Ruhestand ist, wurde zuletzt
der OECD signifikante Krebsbefunde in den durch Dokumente aus dem Gerichtsakt gegen
Tierexperimenten der Hersteller als Zufallser- Monsanto schwer kompromittiert.
gebnisse verworfen und berief sich dabei auf
die von Monsanto bezahlte Übersichtsarbeit Zusammengefasst sind die Bemühungen von
von Greim und Kollegen. Verworfen wurden Herstellern, Behörden und Personen, Glyphosat
auch signifikante Belege für Lymphdrüsen- und Glyphosatpräparate entgegen den Bewei-
krebs bei Mäusen. Dabei gibt gerade dieser sen für ihre krebserzeugende und DNA-schädi-
Befund besonderen Anlass zur Sorge, da eine gende Wirkung zu verteidigen, wissenschaftlich
häufige Form von Lymphdrüsenkrebs, das Non unseriös und von ernsthaften Interessenkon-
Hodgkin Lymphom, bei Glyphosat-exponierten flikten unterminiert.
Menschen gehäuft beobachtet wird.
Die Fortführung der Europäischen Genehmi-
Die Glyphosat-Bewertungen von Behörden gung von Glyphosat brächte ein inakzeptables
und Expertengruppen sind durch ernste In- Risiko für Krebserkrankungen, das bei Einhal-
teressenkonflikte kompromittiert, mit denen tung der Gesetze und Wahrung der wissen-
sich Kapitel � auseinandersetzt. Dieselben Per- schaftlichen Redlichkeit vermieden würde.
sonen, die bereits in den ����er Jahren für
Deutschland mit der europäischen Bewertung Mit Blick auf unsere Erkenntnisse empfehlen
von Glyphosat befasst waren, sind es zum Teil wir, Bewertungen von Glyphosat und Glypho-
heute wieder. Zwischenzeitlich hatten sie nicht satpräparaten durch Personen und Instituti-
nur ihre eigene Glyphosat-Bewertung auf Ebe- onen, die durch Interessenkonflikte belastet
ne der EU-Kommission evaluiert sondern ver- sind, außer Acht zu lassen.
fassten auch für die Glyphosat-Bewertungen
durch das FAO/WHO-JMPR die Vorschläge. Diese Personen und Institutionen sollten zu
den in diesem Bericht vorgebrachten wissen-
Wenn Personen gebeten werden, ihre eigene schaftlichen Argumenten und Beweisen öffent-
frühere Bewertung zu beurteilen, werden sie lich Stellung nehmen.
wenig geneigt sein, eventuelle Fehler einzu-
Zusammenfassung 6 | Glyphosat und Krebs, Gekaufte WissenschaftIntroduction 2
Chapter �
Monsanto has a problem – and comes up with a solution 3
Chapter �
Bad science of industry-sponsored papers defending glyphosate 10
Chapter �
Individual conflicts of interest among defenders of glyphosate 20
Chapter �
Bad science of the regulatory authorities 31
Chapter �
Institutional conflicts of interest in regulatory and expert bodies 39
Conclusion and recommendations 48
References 50
Impressum:
Umweltschutzorganisation GLOBAL 2000/
Friends of the Earth Austria,
Neustiftgasse 36
1070 Wien, Österreichon the market. However, that market was
Introduction
threatened when in ���� the World Health
Organization’s cancer agency IARC, based on
a comprehensive review of the peer-reviewed
scientific literature, classified glyphosate as a
Glyphosate-based herbicides are the most probable human carcinogen.�
widely used herbicides in the world. The best
known glyphosate product is Monsanto’s Monsanto�� and various regulatory and expert
Roundup. The use of glyphosate-based herbi- bodies��,��,�� denied or downplayed the link be-
cides has massively expanded since the intro- tween glyphosate and cancer. This view has
duction in the mid-����s of genetically modi- been reinforced by the publication of a series
fied (GM) glyphosate-tolerant crops,� which are of industry-sponsored and -supported reviews
engineered to survive being sprayed with large in peer-reviewed scientific journals, which con-
amounts of the herbicide. Around ��% of GM cluded that glyphosate and its commercial for-
crops are glyphosate-tolerant.� mulations do not cause cancer and other seri-
ous diseases.
However, glyphosate has many other uses. It is
sprayed to “dry down” or desiccate many types Nearly two years after IARC published its ver-
of crops before harvest. It’s also used for weed dict, the row rages on. Yet the question of
control by farmers, home gardeners, and public whether glyphosate and its commercial herbi-
authorities on roads, pavements, railway lines, cide formulations cause cancer could affect the
parks, school grounds, and other public areas. health and lives of millions of people.
So it’s perhaps no surprise that glyphosate The public relies on the judgments of regula-
turns up everywhere: in rain and air,� streams,� tory and expert bodies to protect them from
and people’s blood� and urine.� the harmful effects of pesticides. They expect
these bodies to act objectively in the public in-
Its widespread use also explains why glypho- terest and to base their opinions on the best
sate is such a lucrative product for the agro- science. So it is vital that these bodies strictly
chemical industry. The global glyphosate mar- guard their independence from industry and
ket is expected to cross US$ �� billion by ����.� carry out their assessments using the most rig-
orous analytical methods.
The last patent on glyphosate expired in ����.
The chemical is now manufactured by many This report examines whether these bodies
companies, including Monsanto, and is includ- are truly independent and objective in their
ed in numerous herbicide brands throughout assessments of glyphosate, as well as looking
the globe.� at the quality of the scientific arguments they
rely upon. The report analyzes conflicts of in-
Monsanto maintains its share of the global terest of individuals and institutions that have
glyphosate market by packaging and selling defended the safety of the chemical and asks
its glyphosate-tolerant (Roundup Ready) GM whether there is any connection between con-
seeds with its own brands of glyphosate herbi- flicts of interest and scientific practice.
cides. It’s been estimated that in ���� the com-
pany made nearly $�.�� billion in sales and $�.� A future report in this series will examine the
billion in gross profits from herbicide products attacks on IARC, which reached a peak after the
– and most of that was from Roundup. That agency published its opinion on glyphosate. It
represents a significant portion of the global will look at the criticisms leveled against IARC
glyphosate market.� and scientists associated with it and examine
the issue of conflicts of interest as it relates to
It is clear that there are huge financial inter- individuals on both sides of the debate.
ests in keeping glyphosate herbicide products
1 | Glyphosate and cancer, Buying scienceChapter � included in the dossier submitted by industry
to regulators.�
Monsanto has a
This presented Monsanto with a problem. That’s
because in recent years, a growing number of
problem – and
peer-reviewed studies in the published scientif-
ic literature have pointed to the harmful ef-
fects of glyphosate and its commercial formu-
comes up with a lations.� If these studies were taken seriously by
the European authorities, glyphosate might be
solution banned.
This was an especially likely outcome in the
light of the fact that Europe’s pesticide regu-
“Companies often contest scientific evidence lation (����/����) has hazard-based cut-off
of the hazards related to their products, with criteria for carcinogenicity and genotoxicity
some even standing accused of deliberately (DNA-damaging effects, which can lead to can-
manufacturing evidence to infuse scientific un- cer), among certain other serious toxic effects.
certainty and delay restrictions. There are also This means that pesticide active ingredients
serious claims of scientists being ‘bought’ to re- that are classified under the European system
state industry talking points.” as carcinogens in category �A (known to have
– UN Report of the Special Rapporteur on the carcinogenic potential for humans, largely
right to food, � January ����� based on human evidence�) or �B (presumed to
have carcinogenic potential for humans, large-
In ���� the European authorization for gly- ly based on animal evidence�) or as category �A
phosate, the active ingredient of the most or �B mutagens* are not allowed to be market-
widely used herbicides in the world, was due ed.� No negotiation is possible based on argu-
to expire. Monsanto and other companies that ments that the doses that people are exposed
market glyphosate herbicides, united in a co- to are believed safe and that therefore the risk
alition called the Glyphosate Task Force (GTF), is acceptably low.
applied to the authorities for re-authorization
of the chemical. Monsanto and other glyphosate manufactur-
ing companies duly prepared their dossier of
But something was getting in the way: science. safety studies on glyphosate – including stud-
ies from the peer-reviewed scientific literature.
To understand why, we need to consider the They submitted it to the German authorities
way that pesticides have been approved in the in May ���� (see Renewal Assessment Report,
past and how that has changed. p. �).� For both the current re-evaluation of
glyphosate and the initial approval in ����,
Historically, applications for pesticide approv- Germany has been the “rapporteur” member
als have been almost exclusively based on safe- state, responsible for overseeing the applica-
ty studies sponsored and provided by the pesti- tion and liaising between industry and the EU
cide industry. authorities in the authorization process. The
RAR contains BfR’s comments and conclusions
But in ���� in Europe, this situation changed. on the GTF’s summaries of the results of the in-
The new pesticides regulation, ����/����, spec- dustry studies.
ified for the first time that in addition to the
industry studies, studies from the “scientific The RAR reveals that when it came to genotox-
peer-reviewed open literature” must also be icity, Monsanto was faced with a problem. The
*
For the purposes of this report we use the terms “genotoxin” and “mutagen” synonymously. The difference is small and most
genotoxins cause mutations. A mutagen causes mutations – heritable changes in the DNA (inherited by the next generation
through the germ cells of their parents). A genotoxin causes all types of DNA damage, which includes aspects that are not herita-
ble. Thus, a mutagen is a type of genotoxin. EU regulations ����/���� and ����/���� speak of “mutagens” in category �A and �B,
but refer to “genotoxicity testing”.
2 | Glyphosate and cancer, Buying scienceRAR lists the findings of a number of peer-re- By October ���� Monsanto and other compa-
viewed studies identified in industry’s litera- nies that wanted glyphosate to be re-approved
ture search that look at the genotoxic effects had formed the Glyphosate Task Force, which
of glyphosate and its commercial formulations. is led by Monsanto.� Monsanto also set up a
The majority of studies on both glyphosate and website that makes reassuring claims about the
the formulations are positive – in other words, safety of glyphosate.� Among them are that
they found that glyphosate can damage DNA glyphosate “is not carcinogenic and does not
(see pages ���–���).� have mutagenic effects, i.e. it does not alter
DNA”.�
Things did not look good for glyphosate.
Monsanto and its allies were badly in need of
a strategy to save the chemical and keep it on The IARC bombshell
the market. If science was getting in the way of
glyphosate’s re-approval, then perhaps anoth- In ���� a bombshell hit Monsanto and its fel-
er kind of “science” was needed. low agrochemical firms when the International
How the regulatory by other scientists. If they are It is only fair that industry pays
system fails the public judged worthy of publication, for the studies that are carried
they are openly published. out to assess the safety of indus-
This allows studies in the trial products, like pesticides.
Most members of the public peer-reviewed literature to be However, industry should pay
believe that the regulatory freely discussed and replicated the money into a fund admin-
system protects them against and their findings confirmed, istered by a public body, which
exposure to unsafe products. refined, or refuted – a defin- would then commission inde-
Specifically, many people as- ing feature of science. pendent laboratories to carry
sume that regulators perform out the tests. Industry must not
or commission independent Does it matter that safety directly sponsor or become the
tests on pesticides to ensure research is sponsored by in- “owner” of a study.
that they are safe. These peo- dustry? The evidence shows
ple are shocked to learn that that it does. Reviews of the The ���� EU pesticides reg-
in order to reach their evalu- scientific literature on the ulation required industry
ation, regulators and agencies safety, toxicity, or efficacy of for the first time to include
across the world read indus- various products show that academic studies from the
try-commissioned toxicology industry-linked studies are peer-reviewed literature in
studies – studies that are clas- far more likely than studies the dossiers it submits to reg-
sified as commercial secrets by scientists working inde- ulators.2 This move attempted
and are generally unpub- pendently of the industry to to open up the regulatory sys-
lished, meaning that indepen- find the product under exam- tem to the published discover-
dent scientists cannot assess ination to be safe and effica- ies of scientists working out-
the data, their interpretation, cious. That applies to a wide side the industry.
and the conclusions drawn range of risky and controver-
from them. sial products – from tobacco�, But as this report shows,
10
to pharmaceutical drugs,11,12 industry is fighting back by
This runs counter to the prin- mobile phones,13 cognitive or sponsoring reviews in peer-re-
ciple of science, which has cardiovascular function, hor- viewed journals with conclu-
always progressed through mone levels, symptoms, and sions that are favourable to its
open publication in the subjective well-being and products. It is assisted by reg-
peer-reviewed literature. The genetically modified (GM) ulatory authorities’ reluctance
idea of peer-reviewed pub- foods14 and crops.15 There is to give much weight to the
lication is that prior to pub- no reason to believe that pes- findings of academic scientists
lication, studies are checked ticides are an exception to and by their preference for in-
for quality (“peer-reviewed”) this rule. dustry studies.16
3 | Glyphosate and cancer, Buying scienceAgency for Research on Cancer (IARC), an arm Industry-sponsored
of the World Health Organization, classified
glyphosate as a probable human carcinogen. reviews reassure on glypho-
The agency based its verdict on “sufficient” ev- sate safety
idence of carcinogenicity in animals and “lim-
ited” evidence in humans. It added that there Monsanto and other companies financed a se-
was “strong” evidence that glyphosate is geno- ries of peer-reviewed scientific reviews, all of-
toxic (damages DNA).�� Genotoxicity is one of fering reassuring conclusions about the safety
the mechanisms through which a chemical can of glyphosate herbicides. Some key reviews are
cause cancer. introduced below and a selection is analyzed
for scientific quality in Chapter �. The conflicts
IARC has a policy of only considering studies of interest of some of the authors are detailed
that are publicly available,�� unlike pesticide in Chapter �.
regulators, who consider mainly industry stud-
ies that are commercial secrets and mostly un- It is significant that industry fought back
published.�� against the studies finding harm from glypho-
sate and its formulations with “reviews”, not
IARC is internationally respected for its ex- with primary research. That means that Mon-
pertise and independence. Its carcinogenicity santo paid scientists to evaluate the scientific
classifications are utilized by government agen- quality of primary research studies. They effec-
cies worldwide. Clearly, in order to avert bans tively tell us what is sound science and what is
and restrictions on the herbicide, the industry junk science.
would have to fight back hard.
The first counterblow came in the media. History of Monsanto-
Hugh Grant, Monsanto’s chairman and CEO,
dismissed the IARC report as “junk science” supported reviews
that was creating “confusion for consumers”.��
Robb Fraley, Monsanto’s chief technology of- For at least two decades, Monsanto has fi-
ficer, said, “We are outraged with this assess- nanced or otherwise supported the publication
ment. This conclusion is inconsistent with the of peer-reviewed reviews with conclusions em-
decades of ongoing comprehensive safety re- phasizing the safety of glyphosate and glypho-
views by the leading regulatory authorities sate-based herbicides.
around the world that have concluded that all
labeled uses of glyphosate are safe for human For example, in ���� the former Monsan-
health. This result was reached by selective to consultant Gary Murray Williams23 and col-
‘cherry picking’ of data and is a clear example leagues published a Monsanto-supported re-
of agenda-driven bias.”21 view in the industry-linked journal* Regulatory
Toxicology and Pharmacology that concluded
In reality, however, this claimed decades-long that glyphosate is non-carcinogenic and that
regulatory consensus is false. What Monsan- “under present and expected conditions of use,
to omits is that in ����, the US Environmental Roundup herbicide does not pose a health risk
Protection Agency (EPA) classified glyphosate to humans.”24
as a possible human carcinogen, based on ex-
periments showing kidney tumours in glypho- Another example was a ���� review sponsored
sate-treated mice. Input from Monsanto led to by Monsanto�� that appeared to try to counter a
a dubious reinterpretation of these studies by growing body of evidence from animal and hu-
the EPA and the reclassification of glyphosate man studies linking glyphosate and its formula-
as non-carcinogenic in ����.22 tions to adverse reproductive outcomes.��,��,��,��
This review of developmental and reproductive
outcomes in humans and animals after gly-
phosate exposure concluded, “The available
* See Chapter 3, “Intertek papers published in industry-linked journal”
4 | Glyphosate and cancer, Buying scienceliterature shows no solid evidence linking gly- Thanks to recently released documents,�� we
phosate exposure to adverse developmental or now know in detail how Monsanto developed
reproductive effects at environmentally realis- a strategic plan for placing industry’s opinion,
tic exposure concentrations.”�� in the form of the Kier and Kirkland review, in
the “independent scientific literature”.
Below are listed some of the key reviews that
Monsanto and other pesticide companies have In ����, Roger McClellen, editor of the journal
sponsored and supported that promote the notion Critical Reviews in Toxicology, was approached
of the safety of glyphosate and its formulations. by Larry Kier, clearly to pave the way for pub-
lishing the review. Thought was given to how
to create “credibility”, in the light of contra-
Key review 1: dictions between industry’s confidential study
Kier and Kirkland (2013)30 reports “weighing in on negative genotox re-
sults vs. the publication record weighing in on
As the IARC report�� and even BfR’s Renewal positive genotox results”.�� See the excerpt be-
Assessment Report on glyphosate found, there low from email dated �8 July ����, from David
are a large number of studies in the peer-re- Saltmiras of Monsanto, on p. �8� of the pdf of
viewed scientific literature that indicate that released documents: �)
glyphosate and its formulations are genotoxic�
and thus could be mutagenic. According to the This paper was submitted on �9 December
EU pesticides regulation, active substances that ���� and published on �� March ����, and it
are mutagenic in mammals must be banned.� had its price. By adding David Kirkland to the
Moreover, genotoxicity in general serves as manuscript, the estimated cost jumped from
mechanistic evidence for carcinogenic effects. US$9,��� to roughly US$��,���, although
Kirkland indicated that “his efforts will be less
Kier and Kirkland’s review (����)�� addressed than �� days”�� (p. �9� of the pdf), with a daily
the question of glyphosate’s genotoxicity honorarium of approximately US$�,��� (�,���
and concluded that glyphosate and glypho- British pounds). Monsanto termed this “a fair
sate-based herbicides do not present “signifi- investment” (p. �8� of the pdf).�� We call it
cant genotoxic risk” in normal exposures. The “buying science”. �)
review was funded by the Monsanto-led Gly-
phosate Task Force.�� Larry Kier is a former The reason that Monsanto spent all this money
Monsanto employee and David Kirkland is a was that the original version (written by Larry
former consultant to Monsanto.23 Kier alone) “stretched the limits of credibility”
�)
�)
5 | Glyphosate and cancer, Buying science�)
and “this became a very difficult story to tell cations to the IARC monograph (see below) and
given all the complicated ‘noise’ out there”�� yet did not contact the nominal authors of these
(p. �8� of the pdf). �) papers. It is, of course, possible that the contact
between Monsanto and the nominal authors
On �9 February ����, in a similar move, Mon- was indirect, but nonetheless it would have
santo strategically planned to counter the re- been ultimately controlled by Monsanto. 5)
sults of the IARC meeting. For that, they were
willing to pay US$���,��� or more, “depend-
ing on what comes out of the IARC meeting”��
(p. ��� of the pdf). The results were the “In-
tertek papers” of ���� (see “Key reviews �–7:
The Intertek papers (����)”, below). Monsanto
was just not sure in which science disciplines
the money should be invested. To keep the
cost down, Monsanto considered ghost-writ-
ing papers so that the “expert” nominal au-
thors “would just edit & sign their names so to
speak”. Monsanto’s remark, “Recall that is how
we handled Williams Kroes & Munro, ����”��
(a much cited review), indicated that this had
worked before (see p. ��� of the pdf). �) 5)
4)
This strategy appears to be in stark contrast In the light of this strategy, another statement
with the claim that the nominal authors of the by Williams and colleagues also appears diffi-
Intertek papers “were not directly contacted cult to believe: “Neither any Monsanto com-
by the Monsanto Company” (Williams and col- pany employees nor any attorneys reviewed
leagues, ������). It is hard to believe that Mon- any of the expert panel’s manuscripts prior to
santo was strategically planning counter-publi- submission to the journal.”�� Alternatively, the
6 | Glyphosate and cancer, Buying sciencestatement may be technically true, but it does The timing of this review is worth noting. It
not rule out the possibility that Monsanto em- was published online on �� February ����.�6 This
ployees actually wrote the manuscripts or parts was three weeks before the initial publication
of them. If that were the case, there would in The Lancet of IARC’s classification of glypho-
have been no need for them to “review” their sate as a probable carcinogen.�7 It was also in
own work. time to influence the final draft of the Renew-
al Assessment Report,� which was submitted
It seems that these investments in Monsanto- by the BfR via BVL to EFSA on �� March ����.
and Glyphosate Task Force-sponsored “inde- Greim and colleagues may have been aware
pendent” publications have paid off well. BfR’s of that date, since in their review they cite the
Renewal Assessment Report refers to Kier and previous draft of the Renewal Assessment Re-
Kirkland’s paper of ���� to emphasize “the port (dated �� January ����). That draft was
overwhelming preponderance of negative re- not publicly available, so it appears that Greim
sults in well-conducted bacterial reversion and and colleagues were given privileged access.
in vivo mammalian micronucleus and chromo- Also, Greim and colleagues’ review is cited in
somal aberration assays”, which indicate “that BfR’s Renewal Assessment Report (version of ��
glyphosate and typical GBFs [glyphosate-based March ����, p. ���).
formulations] are not genotoxic”.��, � More-
over, the more recent evaluation by the US EPA
made major reference to Kier and Kirkland and Key reviews 3–7:
followed their conclusions.�� The Intertek papers (2016)
The “Intertek papers” also made it into the A major aspect of Monsanto’s strategy against
evaluation conducted by the Federal Insecti- the IARC verdict was to sponsor a series of five
cide, Fungicide, and Rodenticide Act Scientific scientific reviews,38, 39, 32, 40, 41 which were all pub-
Advisory Panel (FIFRA SAP) of the US EPA’s re- lished in late ���� in the same peer-reviewed
port on glyphosate. The panel recommended journal. As stated in the declarations of interest
that “several relevant papers” which “have in each paper, all were funded by Monsanto via
been published… should be reviewed…. These Intertek. The lead review carries the following
manuscripts include reviews by Acquavella statement: “This article is part of a supplement,
et al., ����, Williams et al., ����, and several sponsored and supported by Intertek Scientif-
others that will be readily identified by US EPA ic & Regulatory Consultancy. Funding for the
when it updates its literature search.”�� sponsorship of this supplement was provided
to Intertek by the Monsanto Company, which is
a primary producer of glyphosate and products
Key review 2: containing this active ingredient.”�2
Greim and colleagues (2015)36
For the purposes of this report we call these
This review, an evaluation of the carcinogen- reviews the Intertek papers.
ic potential of glyphosate, was published in
���� and was co-authored by (among others) All of these reviews defended the safety of
Helmut Greim, MD, Professor Emeritus, Toxi- glyphosate with regard to key health effects.
cology and Environmental Hygiene, Technical Their specific aim was to counter IARC’s evalua-
University Munich, and a former consultant to tion of glyphosate as a probable human carcin-
Monsanto.�� A co-author was David Saltmiras, a ogen and as genotoxic (damaging to DNA), as
Monsanto employee. Greim was paid by Mon- the articles themselves explicitly state. In addi-
santo for providing his expertise. The review tion, an accompanying commentary by the ed-
concluded that “glyphosate does not present itor of the journal stated that the Intertek pa-
concern with respect to carcinogenic potential pers were intended to counter IARC’s verdict.42
in humans”.�6
7 | Glyphosate and cancer, Buying scienceConclusion In ���� a new regulation was passed in Eu- rope that required industry to include studies from the peer-reviewed scientific literature in the dossiers submitted in support of pesticide approvals. Taken together with studies from industry, many of these studies link glyphosate and its commercial formulations with harmful effects, including carcinogenicity and genotoxicity. As pesticide active ingredients with carcinogenic potential are not allowed to be marketed in Eu- rope, a proper evaluation of the science would necessarily lead to glyphosate being banned. The onslaught of scientific articles showing problems with glyphosate reached a peak in ���� with the publication of a report by IARC, the World Health Organization’s cancer agen- cy, classifying glyphosate as a probable carcin- ogen and pointing to evidence that it is geno- toxic. For the past two decades, Monsanto and other companies have countered such developments by financing and supporting the publication of scientific reviews in peer-reviewed journals. These reviews reach reassuring conclusions about the safety of glyphosate and its commer- cial formulations. In Chapter � we analyze the scientific quality of some of these publications. In Chapter � we detail the conflicts of interest of the authors – including links to Monsanto and other agro- chemical firms; the industry-funded Interna- tional Life Sciences Institute (ILSI); and testing and consultancy firms that serve industry. 8 | Glyphosate and cancer, Buying science
Chapter � concern with respect to carcinogenic potential
in humans”.�
Bad science of in-
Greim and colleagues presented incidence ta-
bles of several types of tumour. However, these
dustry-sponsored
were irrelevant for the assessment because
they were clearly not related to treatment with
glyphosate. This can be seen from the pattern
papers defending of the tumour incidences – there is no increase
as compared to the control groups, no signifi-
glyphosate cance in the increases, and/or no dose-depen-
dence. They comprised lung adenomas, lung
adenocarcinomas, broncho-alveolar adenomas,
broncho-alveolar carcinomas, and pituitary ad-
In Chapter � we saw how, in response to a enomas in mice.�
growing number of peer-reviewed scientific
studies finding serious health risks from gly- It would be fully appropriate to include these
phosate and its commercial formulations, Mon- tumours in the tables if it were done to provide
santo and other companies and industry-linked the complete picture. But Greim and colleagues
bodies commissioned or otherwise supported did something very different. They listed these
the publication of counter-reviews that de- irrelevant tumours – yet failed to mention
fended the safety of the chemical.* those tumours that were significantly increased
in incidence in glyphosate-treated animals (as
Many of the authors of these reviews had con- revealed by BfR’s Addendum to the Renewal
flicts of interest with industry or industry-linked Assessment Report�).
bodies. These are analyzed in detail in Chapter �.
To sceptical members of the public and scien-
However, some might argue that such con- tific community, this may at the very least ap-
flicts of interest do not matter as long as the pear to be misleading and at worst may appear
scientific quality of the reviews is sound. With to be fraud. For example, this applies to the fol-
that in mind, we offer the following analysis lowing studies:
of several of the Monsanto-sponsored Intertek
papers, along with some additional reviews • Mouse study of ���� (sponsor: Chemino-
sponsored by glyphosate manufacturers that va). Greim and colleagues did not mention
also defend glyphosate-based herbicides. the statistically significant increase in hae-
mangiosarcomas (blood vessel cancers) in
glyphosate-treated animals.
Bad scientific practice no. 1:
• Mouse study of ���� (Arysta Life Science).
Flood the reader with Greim and colleagues did not mention the
irrelevant data, but omit the statistically significant increase in haeman-
giosarcomas and kidney tumours in gly-
important data phosate-treated animals.
Greim and colleagues (2015)1 • Mouse study of ���� (Feinchemie Schweb-
da). Greim and colleagues did not men-
This evaluation of the carcinogenic potential tion the statistically significant increase in
of glyphosate by Greim and colleagues (����), kidney tumours in glyphosate-treated an-
which had Monsanto employee David Saltmiras imals.
among the authors and which was supported
by Monsanto and the Glyphosate Task Force, • Mouse study of ���� (Nufarm). Greim and
concluded that “glyphosate does not present colleagues presented the data on malig-
* This appears to be a standard industry tactic in cases where a chemical becomes controversial: for example, it has been extensively
used to defend the herbicide atrazine. See Hayes TB. There is no denying this: Defusing the confusion about atrazine. Bioscience.
����;��:����-����.
9 | Glyphosate and cancer, Buying sciencenant lymphoma in males but did not men- As proof of this claim, they offer “the paper of
tion that these date indicate a highly sig- Greim et al (����),� who evaluated �� carcino-
nificant (p=�.����) and dose-dependent genicity studies, nine chronic/carcinogenicity
increase in malignant lymphoma. Instead, studies in the rat, including one peer-reviewed
they claimed that there were “no treat- published study, and five carcinogenicity stud-
ment-related effects”. ies with glyphosate in mice.” In contrast, Wil-
liams and colleagues point out, “The IARC
Similarly the pancreatic tumours in male rats Monograph reviewed only six rat and two
in the ���� study by Monsanto were not listed mouse studies.”
by Greim and colleagues, although they were
significantly increased in glyphosate-treated The latter statement is true, but ignores IARC’s
animals, while data for pituitary tumours were policy as stated in the Preamble attached to
presented in detail, even though they are not each of its Monographs: “With regard to ep-
relevant because no statistically significant in- idemiological studies, cancer bioassays, and
crease was identified. Likewise the significantly mechanistic and other relevant data, only re-
increased incidence in liver cell tumours in the ports that have been published or accepted in
���� rat study by Monsanto was not mentioned the openly available scientific literature are re-
by Greim and colleagues. viewed. … Data from government agency re-
ports that are publicly available are also con-
It is worth noting that Greim and colleagues sidered.”�
had access to BfR’s internal documents, as they
referred to an interim version of several vol- Industry generally refuses to make its study
umes of the Draft Renewal Assessment Report reports publicly available. So it is ironic that in-
(the �� January ���� revision),� which the pub- dustry’s paid authors criticize IARC for not in-
lic never had access to. The question arises as to cluding these unpublished studies.
why BfR apparently gave Greim and colleagues
“
(including Monsanto’s Saltmiras) privileged ac-
cess to non-public regulatory documents. This Industry generally refuses to make
might be justified with a claim that chemical its study reports publicly available. So it is
producers should receive an advance copy, but ironic that industry’s paid authors criticize
it seems to us that on principle, industry should IARC for not including these unpublished
”
not have access to draft regulatory documents. studies.
Bad scientific practice no. 2: Williams and colleagues argued that the data
from these studies would in fact have been
Take facts out of context to available to IARC because they were “detailed
dismiss inconvenient evidence in a supplement to the Greim et al (����) pa-
per”.� What they omitted to mention is that
IARC did evaluate this publication, but decid-
Williams and colleagues (2016)3 ed not to include it. The sound scientific reason
(Intertek paper) for non-inclusion is described in IARC’s report:
“because the information provided in the re-
After introducing a reasonable concept for view article and its supplement was insufficient
scientific reviews (“In any review, if any studies (e.g. information lacking on statistical meth-
are to be ignored, the reasons for this should ods, choice of doses, body weight gain, survival
be provided”), the former Monsanto consul- data, details on histopathological examination
tant� Gary Murray Williams and colleagues and/or stability of dosed feed mixture).”�
expressed their “opinion that the IARC evalu-
ation showed selectivity in the choice of data In other words, relevant information was held
reviewed, with some omissions for which rea- back by industry.
sons were not clearly presented”.�
10 | Glyphosate and cancer, Buying scienceBad scientific practice no. 3: Kuschner re-evaluated the original ḱidney
sections from Monsanto’s mouse study and
Industry-friendly experts re- claimed to have found a new renal tumour in a
evaluate data until it no lon- control mouse, no. ����.�,��
ger threatens the approval of This was an important tumour for Monsanto.
a pesticide If its existence were confirmed, an age-adjust-
ed statistical analysis would demonstrate no
tumour-causing effect of glyphosate using the
Williams and colleagues (2016)3 controls within the experiment.�� Thus glypho-
(Intertek paper) sate would have been exonerated from suspi-
cion of being a carcinogen.
In March ���� the US Environmental Protec-
tion Agency (EPA) classified glyphosate as a But initially, Kuschner seemed to be the only
group C carcinogen� (“possible human carcin- one who could see the alleged new tumour in
ogen”�). the control mouse. The EPA pathologist Louis
Kasza stated that the alleged tumour “does not
Williams and colleagues address this episode represent a pathophysiologically significant
in their paper, referring to “the renal neo- change”.�, ��
plasms [kidney tumours] that occurred in the
first two-year, oral chronic toxicity, and carcino- To be on the safe side, the EPA arranged for
genicity study in CD-� mice (Monsanto ����).� additional kidney sections to be cut from the
Glyphosate had caused renal (kidney) tubule male mice in all groups of the feeding study.
adenomas, a rare kind of tumour, in a dose-de- The new sections were then examined on slides
pendent manner. There were �, �, �, and � inci- under the microscope by “a number of pathol-
dences of this tumour in the control, low-dose, ogists”, including Kasza. The pathologists con-
mid-dose, and high-dose groups respectively.� firmed the presence of all the tumours report-
ed in the original study. But not one of them
The crucial story that follows is omitted by could find Kuschner’s claimed extra control
Williams and colleagues in their paper, thus mouse tumour.��, �
giving a misleading impression that the car-
cinogenicity concerns were laid to rest on a sci- Therefore Kuschner’s claimed tumour could
entific basis. not be recognized as such in the original slide
or in any of the new sections cut by the US EPA
In the second half of ���� the US EPA classi- scientists.
fication of glyphosate as a possible carcinogen
came under pressure after the original tumours Reporting to Monsanto: the Pathology Work-
were (as reported by Williams and colleagues) ing Group
“re-evaluated by a pathology working group
(PWG)… and peer review experts including Dr In parallel, Monsanto commissioned a group
Marvin Kuschner M.D., Dean, School of Med- of four consultants to review Kuschner’s al-
icine, State University of New York at Stony leged tumour finding and evaluate the signifi-
Brook”.� cance of the kidney tumours. The re-evaluation
took place in the summer or autumn of ����.
According to his biographical entry in Pra-
book, from ���� Kuschner was also a member In their report to Monsanto, these consul-
of Monsanto’s Biohazards Commission�� (see tants, together with the five pathologists that
Chapter �). Williams and colleagues do not in- formed the pathology working group (PWG),
clude any information on Kuschner’s interests. contradicted the US EPA pathologists. They
stated that they were able to confirm Kus-
It is unclear who convened and instructed the chner’s tumour finding in the original slide of
PWG. control mouse no. ����. They also claimed that
they were convinced that the tumours in three
high-dose males were not related to glypho-
sate treatment, but due to chance.��
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