VIA EMAIL Dear Members of the European Commission, Parliament and Member States, This letter contains a link to six expert scientist 1 reports explaining the connection between glyphosate-based formulations ( GBFs ) and the cancer Non-Hodgkin Lymphoma ( NHL ). The reports were written for lawsuits pending against Monsanto Company in the United States 2 and compile epidemiology, toxicology, and oncology evidence important for regulators like the European Commission to assess, along with the Monsanto Papers, when determining whether to extend or restrict the use of GBFs in Europe. Brief summaries of each expert s significant conclusions regarding the epidemiological and toxicological data are provided below. We are expecting more documents from the ongoing U.S. litigation to be de-classified in the near future, a number of which pertain to communications between Bfr, BVL, EFSA, and Monsanto that may of interest to European lawmakers. Epidemiological Data Shows GBFs Induce NHL Numerous independent studies find statistically significant elevated risks between exposure to GBFs and NHL, and those studies which do not find statistically significant risks still consistently observe an elevated risk. Dr. Ritz conducted a comprehensive literature search 1 Dr. Beate Ritz, Chair of the Epidemiology Department at the University of California, Los Angeles ( UCLA ); Dr. Alfred I. Neugut, Professor of Cancer Research and Professor of Medicine and Epidemiology at Columbia University, New York; Dr. Christopher Portier, former Associate Director of the National Toxicology Program; Dr. Jameson, former Program Leader for the National Toxicology Program; Dr. Chadi Nabhan, board-certified clinical medical oncologist specializing in lymphomas and past Assistant Professor of Medicine at the University of Chicago, currently serving as Medical Director of Cardinal Health, Dublin, Ohio; Dr. Dennis D. Weisenberger, Chair of the Pathology Department of the City of Hope Medical Center, Omaha, Nebraska, specializing in NHL. 2 In Re Roundup Products Liability Litigation, 3:16-md-2741-VC, Federal Court for the Northern District of California.
Page 2 and presented a chart in her report (attached) which demonstrates that of the 32 GBF/NHL epidemiology studies, 28 showed a higher risk of NHL for persons exposed to GBFs. In statistical terms, 28 of the Odd Ratios (ORs) 3 are higher than 1 4, indicating a consistently elevated risk associated with glyphosate exposure. Ritz Rpt. at 14. If there were no risk of GBFs causing NHL, one would expect to see an equal distribution of ORs above and below 1. Portier Rpt. at 15 ( [I]f the true underlying risk ratio was 1 (no effect), you would expect about half of the findings to be below 1 and half to be equal to 1 or greater.); Neugut Rpt. at 22 ( [I]f the two phenomena were truly random, then the measured associations in the studies should have randomly distributed themselves around 1. ). Here, we see the opposite. Overall the studies are pointing in the same direction toward a positive effect. Neugut Rpt. at 22. The probability of so many studies showing an elevated risk in the absence of GBFs actually inducing NHL is extremely remote. Moreover, the EFSA previously dismissed the available epidemiological data and concluded that [a]part from the Agricultural Health Study, there were no other large studies with good quality data for many study outcomes. Scientific Opinion of the PPR Panel on the follow-up of the findings of the External Scientific Report Literature review of epidemiological studies linking exposure to pesticides and health effects at 21:974. The Agricultural Health Study ( AHS ) has been relied upon by Monsanto for the contention that glyphosate does not cause cancer. However, Dr. Ritz noted several methodological limitations with the AHS such as: 1) a short period of time between enrolment of participants to follow up (when participants are asked about their disease status). This did not allow sufficient time between exposure to GBFs and potential cancer incidence (the latency period ). Ritz Rpt. at 20; 2) the study had the smallest sample size of any study reviewed, Id. at 21, which calls into question the precision of its point estimates; and 3) given that the first enrollees were providing data in 1993, two years before a substantial increase in glyphosate use, while later enrollees provided data two years after the increased use (1997), the time-varying exposure creates non-differential misclassification which biases the results towards the null. Ritz Rpt. at 8, 22; Neugut Rpt. at 13. When the available case-control studies are considered in conjunction with the published meta-analyses, there is an observed positive association between exposure to GBFs and NHL. See Ritz Rpt. at 16; Neugut Rpt. at 17. 3 An odds ratio, or OR, is a measure of association between an exposure and a disease. It represents the odds that the disease will occur in a group of people given a particular exposure, in comparison to the odds of the disease in a group of people without the exposure. Ritz Rpt. at 3. 4 1.0 represents a null finding, meaning no association between exposure to GBFs and NHL. Odds Ratios greater than 1.0 ( to the right of 1.0 ), such as 1.5, 1.7, 2.0 indicate an increased risk of NHL for individuals exposed to GBFs compared to those who have not.
Page 3 Reliance on an Unpublished AHS Draft Manuscript to Overcome Problems with the Original AHS Study Is Invalid Monsanto obtained an incomplete, unpublished, preliminary 96-page draft analysis of AHS and has been encouraging regulators and the general public to reject IARC s findings in favor of the unfinished draft manuscript. This version has not been published due to its flaws. In the incomplete manuscript, the AHS researchers attempted to address the original AHS analysis problems. The researchers conducted follow-up questionnaires to get more up-to-date exposure information to address the original studies exposure limitations. Unfortunately, nearly 40% of the original study participants did not respond; thus, only about 60% of the exposure data was updated. To fix this new problem, the researchers then imputed data from the people who did respond. This is improper: Ritz Reb. Rep. at 4. While under some, limited circumstances it is an acceptable epidemiological approach to impute or guestimate certain unavailable data, one must be extremely careful when imputing/guestimating a critical piece of data, such as exposure... The validity of the results of such an imputation/guestimation become extremely questionable because when applied, the study authors need to assume glyphosate/gbf use was based on historical use, and do not apply the increased use for any person who did not report their pesticide use, i.e. the nonresponders. These significant errors in the draft manuscript highlight the pitfalls of relying on unpublished material. Monsanto encouraging agencies like EFSA, BfR, ECHA, and the EPA, as well as the scientific community, to rely on the results of the unpublished, flawed data is disingenuous and misleading. No regulators should allow their licensing decisions to be based on such unreliable data. Significant Carcinogenicity Findings Within the Toxicological Data A review of the toxicological literature by analyzing animal bioassays led Dr. Portier to conclude that glyphosate has been demonstrated to cause cancer in two strains of rats and one strain of mice. Portier Rpt. at 51. Moreover, Dr. Jameson determined that in CD-1 mice, glyphosate exposure causes kidney tumors in males in two separate studies, hemangiosarcomas in males in two separate studies, malignant lymphoma in males in two separate studies, adenocarcinomas of the lung in males in one study, and hemangiosarcomas in females in one study. Jameson Rpt. at 29. Significantly, neither the EFSA, EChA nor EPA analyzed the supplemental data presented in Greim et al. (2015). The decisions of these agencies are based on the summary tumors reported by industry, not the study authors. Dr. Portier, by contrast, reviewed every data point in the Greim appendix and considered primary and secondary tumors in his analysis. Portier Rpt. at 50 (table 15); Portier Reb. Rpt. at 37 (modified table 15). Following such
Page 4 exhaustive analysis, Dr. Portier was able to conclude that glyphosate probably causes NHL based on the human, animal and experimental evidence and that, to a reasonable decree of scientific certainty, the probability that glyphosate causes NHL is high. Portier Reb. Rpt. at 24. It is imperative that European regulatory agencies and lawmakers are presented with transparent and reliable evaluations of the scientific data on GBFs and cancer. We hope that a review of the above experts opinions will contribute to the protection of the health of Europeans. Best, BAUM HEDLUND ARISTEI & GOLDMAN, P.C. Enclosures By: Michael L. Baum, Esq. Pedram Esfandiary, Esq. R. Brent Wisner, Esq.