Document Rpy85JkGdjX05D6bJ5k3GmkDV

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 MEMORANDUM OFFICE OF SOLID WASTE AN D EMERGENCV RESPONSE . DATE: February 23, 1990 SUBJECT: Newly Revealed Fraud by Monsanto in an Epidemiological Study Used by EPA to Assess Human Health Effects from Dioxins FROM: Cate Jenkins, Ph.D. {~*a?if*** Chemist, Waste Characterization Branch (OS 332) Characterization and Assessment Division TO: Raymond C. Loehr, Ph.D. Chair, Executive Committee Science Advisory Board (A 101) Office of the Administrator On November 28, 1989 you transmitted to the Administrator a review by the Science Advisory Board (SABI1 of "A Cancer RiskSpecific Dose Estimate for 2,3,7,8-TCDD." This review concluded that the existing epidemiologic studies were conflicting, and did not provide definitive data on human health effects of dioxins, and thus EPA should continue to utilize animal toxicologic data as a basis for dioxin risk assessments. A key epidemiological study leading to this conclusion was performed by Monsanto Corporation. This study examined medical records were examined of employees exposed to dioxins from a 1949 explosion of a 2,4,5-trichlorophenol manufacturing process, and U.S. EPA, Science Advisory Board, Ad Hoc Dioxin Panel (November 28, 1989) Review of Draft Documents "A Cancer RiskSpecific Dose Estimate for 2,3,7,8-TCDD and "Estimating Exposure to 2,3,7,8-TCDD." 2 U.S. EPA, Office of Health and Environmental Assessment (June, 1988) A Cancer Risk-Specific Dose Estimate for 2,3,7,8TCDD,EPA Publication No. EPA/600/6-88/007Aa. Printed an Recycled Paper found no stati.sti.cally si. gni.fi.cant excess cancer deaths. ^ The Monsanto study was important; since although the exposed populatiori*'Was small (121 workers'), exposure to dioxins was clearly ^stab-lished because the workers experienced chloracne. Other stuSies were confounded by the fact that exposure to dioxins vrasr"not so demonstrated. In Appendix B .of "A Cancer Risk-Specific Dose Estimate for 2,3,7,8-TCDD" this Monsanto study is discussed in juxtaposition with other studies on small populations where excess cancer morbidity and mortality were in fact found. As a result, the studies where excess cancers were observed were rendered suspect. For example, EPA discussed in the same'sentence the fact J:hat although the studies by Thiess et al. and Axelson et al. reported statistically significant excesses of stomach cancer, the study by Monsanto did not. EPA discussed the fact that significantly elevated levels of cancers fe.g. prostate, nonHodgkins lymphoma, connective tissue, soft tissue sarcomas, reticulum cell sarcoma, kidney cancer, etc.) had been found in other dioxin-exposed populations. The study by Monsanto, however, either did not find any such cancers, or the cancers observed were not statistically significant. This study by Monsanto apparently has now been shown to be a fraud. Attached is a brief filed by the plaintiffs in a case where damages are being sought resulting from a spill of dioxincontaminated pentachlorophenol wood preservative by Monsanto. This study* on behalf of Monsanto is described, where it is Zack, J.A. and R.R. Suskind (1980) The Mortality Experience of Workers Exposed to Tetrachlorodibenzodioxin in a Trichlorophenol Process Accident. J. Occup. Med. 22(l):ll-l4. 4 Thiess, A.M., R. Frentzel-Beyme, and R. Link (1982) Mortality Study of Persons Exposed to Dioxin in a Trichlorophenol-Process Accident that Occurred in the BASF AG on November 17, 1953. Am. J. Ind. Med. 3:179-189. ^ Axelson, 0. (1986, Jan. 21) Rebuttals of the Final Report on Cancer by the Royal Commission on the Use and Effects of Chemical^gents on Australian Personnel in Vietnam. Department of Occupational Medicine, University Hospital, Universitetet Linkopingr;:Linkping, Sweden. Plaintiffs-Appellees' Brief (October 3, 1989) Frances E. Kemner, et. a l . v. Monsanto Company, Appeal from the Circuit Court of St. Clair County, Illinois, No. 80-L-970, filed by Rex Carr, CARR, DORIN, TILLERY, DUNIN, MONROY, GLASS & BOGARD, 412 Missouri Avenue, East St. Louis, IL 62201 and Jerome W. Seigfried, SIEGFRIED, RUNGE, LEONATTI & POHLMEYER, P.O. Box 160, 123 East Jackson St., Mexico, MO 65265-0160. 2 m -alleged that the record demonstrated a deliberate course of conduct by;Monsanto through "altered" research to prove to the world thatfjgthe only health consequence of dioxins was the relativeiy^harmless, reversible condition of chloracne. The cross examination of Dr. Roush, Medical Director of Monsanto, was said to cirearly establish the fraudulent nature of the cancer, mortality study by Dr. Zack, a Monsanto employee, and an "independent" researcher, Dr. Suskind, described as having performed "joint" studies with Monsanto. An earlier, predecessor study performed by Dr. Zack was alleged to have deliberately and knowingly omitted 5 deaths from the-group exposed to dioxins in the 1949 accident, while removing 4 workers who had been exposed and putting these workers in the unexposed group, serving to provide an apparent increase the cancer death rate in the unexposed group. The overall cancer death rate was alleged to have actually been 65% greater in the exposed population, with 143% higher lung cancers, 108% higher genitourinary cancers, 809% higher bladder cancers, and 92% higher lymphatic cancers. The Monsanto study performed by Dr. Suskind on workers exposed to dioxins in the 1949 accident, published in 1980 in the Journal of the American Medical Association and the same year in the Journal of Occupational Medicine with Dr. Zack as co-author (this was the study was reviewed by EPA), was also alleged to be fraudulent. It was claimed that the actual medical records revealed gross misclassifications and omissions. The correct classification was said to have been 28 cancers in the exposed group compared to only 2 in the unexposed group; Suskind reported 14 cancers in the exposed group and 6 in the unexposed group. In addition,, it was alleged that in November of 1955, Dr. Suskind colluded with Monsanto to conceal findings of psychoneuroses in the exposed workers from the Workers Compensation Commission. Dr. Suskind was alleged to have falsely stated that workers' nervous system and liver problems had disappeared by 1953, with the stated intention by Suskind to make the world believe that only a few of the workers continued to have problems. Dr. Suskind was reported as acknowledging to the Court that the world and the scientific community were intended to, and indeed had, relied upon his reports of no adverse cancer effects from human exposure^to dioxins. It is|a commonly bandied adage that dioxins have not been demonstrated to have caused cancer in humans, despite documented exposures. Perhaps this may now been seen as yet another "old industry tale" in light of the fraud allegedly committed by Monsanto in conducting its "research" on its workers exposed to dioxins. It could be that other studies on exposed populations are similarly flawed and subject to fraud. 3 I request that the SAB on it own, or by way of direction to EPA's Office of Research and Development, obtain the full files from thej^ngoing case against Monsanto to determine whether definiti^lSjconclusions may now be drawn regarding the evidence estab 1ishlrig- a causal link between dioxins and human cancer in the Monsanto population. I believe that an audit of other dioxin-related human epidemiological studies should be performed, to determine whether misclassification of medical records or other errors has resulted in similarly flawed conclusions. Studies that would be particularly prone to bias would be those performed by any manufacturing firm on its own employees, or in conjunction with an outside researcher, since a positive finding of excess cancer mortality or morbidity would result in the financial liability of that firm. cc: Donald G. Barnes, Ph.D. Director, Science Advisory Board (A 101) Office of the Administrator Hugh McKinnon, Ph.D. Director, Human Health Assessment Group (RD 689) Office of Research and Development Peter W. Preuss, Ph.D. Chairman, Interoffice Workgroup for a Cancer Risk-Specific Dose Estimate for 2,3,7,8-TCDD 4