Document YjVrrpgzg29dEZ2mdM04ygymD

FROM N O R T H S H O R E HOMES INC 0 4 .83.1990 16:58 P. 1 -- /JT esJcj&=} ~Hi/\ ; ~pg, C /rrt, J ^ k / u s V -- L e - C *Lt- 7/^ f ego 6 - FROM NO RT H S H O R E HOMES INC 04.03.1990 16:59 P. 2 The international Independent Agent Orange fretwork 6806 - 36 Avenue S.E. Olympia, Washington 98503 (206) 459-7189 Tuesday, April 3, 1990 Raymond C. Loehr, Ph.D. Chair, Executive Committee Science Advisory Board Office of the Administrator United States Environmental Protection Agency Washington, D.C. 20460 Re: James fr. Sanger/Kcmner/Monsanto Dear Dr. Loehr: I have taken the liberty of reproducing of Mr, James H. Sanger's communication to you, with regard to the fritro plant studies, for the purpose of my critique of Mr. Sangcrs perceived perception of the documents in question. Inasmuch as I can only assume the 25 pages of documents from the Kemncr et al. ,v-Monsanto appellees brief, are the same as the ones I have had the opportunity to re v ie w , my critique is based on what I have read. I am not a scientist, nor an attorney, however, neither am 1 an unaware citizen. I would appreciate your taking the time to review this critique of my perceptions and responding in kind. I am a columnist for The Stars & Stripes, The National Tribune, of Washington, D.C., and B.R.A.V.O. The Veterans Outlook, therefore, your comments will be subject to publication in my column. There are other questions I have regarding this document, however, those currently included in the document, w i l l perhaps clarify those remaining. Thanking you in advance for taking the time to review this most serious issue. Cordially, 6806 36th Ave. S.E. Olympia, Wa. 98503 pc; Independent Agent Orange fretwork James H. Sanger Monsanto Company 800 fr. Lindbergh Boulevard S t . Louis, M is s o u r i 63167 314-694-1000 FROM NOR THSHORE HOMES INC 0 4 . 0 3 . 1 9 9 0' 1 7 : 0 0 t, 3 Raymond C, Loehr, Ph.D. Chair, Executive Committee Science Advisory Board Office o f the Administrator United States Environmental Protection Agency Washington, D.C, 20460 Re: Monsanto Company and Epidemio logi on1 Studies concerning dioxin Dear Dr, Loehr: Monsanto has learned o f the EPA's receipt o f highly inflammatory and inaccurate information pertaining to epidemiology studies involving Monsanto's Nitro, Nest Virginia plant, The materials forwarded to your o ffic e are contained within a legal b rie f submitted by the p la in t iffs ' attorney in the appeal of a lawsuit file d against Monsanto and includes allegations that published study data and\ resu lts were fa ls ifie d by the University o f Cincinnati '$ Kettering Ins i Unte and by Monsanto in a purported e ffo rt to mislead the sc ie n tific world and public regarding the toxic e ffe c ts o f dioxin. These accusations were f i r s t issued years ago by the same lawyer in the same lawsu it and are u tte rly untrue and contrary to the record in that case, (S p e c ific a ily: FRANCES E, KEMPER, e t, a l, and a l l other cases consolidated with cause No, 80-L-970, P laint iffs-A p p e lle e s, v. Monsanto Company) P la in tif f s ' attorn ey# Rex Carr, 412 Missouri Avenue. East S t Louis, I llin o is 62201) (The documents I reviewed, a lleg ed s c ie n tis ts employed by Monsanto , not the Kettering I n s titu te . Can you c la r ify ? ) Considering the genesis o f these accusations i t is recommended that they be examined c ritic a lly , especially in lig h t of the EPA's previous experience with th is source during the Kemner tria l at which several government witnesses (including Dr, Kloepfer o f EPA and Dr, Kimbrough o f GDC) te stifie d , The Kemner tr ia l as which these charges arose involved the claim that Sturgeon, Missouri was unsafe due to dioxin contamination and that i t s residents (p la in tiffs in the su it) had been injured by the teaspoon o f TCDD contained in the 19,000 gallons o f orthochlorophenol crude sp illed during a 1979 train derailment. These health claims were contrary to the conclusions reached by the EPA, the Center for Disease Control and the ju ry- Given the strident nature o f the inaccurate and misleading represen tat i ons contained in the materials in circulation within the Agency, Monsanto believes i t is important that the record should be kept straight .on* the subject, (The ap pellees b r ie f that I have in d ica tes th a t t h e Jury award was for "punitive damages. n unless I am mistaken, Mr, Sanger 'a claim in th is regard, would be fa lse . Can you c la r ify th is m atter?) The central focus o f th materials submitted to the SAB relate to the claim of "newly revealed fraud" in epidemiological studies relied on by the EPA, an allegation which in turn is premised upon a purported s ta tis tic a l "re-analysis'* FROM NOR THSHORE HOMES INC 0 4 .0 3 . 1990 17:00 t. P. 4 p la in t iffs * lawyer, not any expert or tria l witness, The attorney's "reanalys is" was not peer-reviewed and was simply constructed by the p la in tiffs 9 lawyer in the tria l as purportedly representing a valid substitute for the peerreviewed studies which i t attacked. The allegations within the legal b rie f which conclude that fraud was committed by Monsanto and that the actual courtroom advocacy o f p la in tiffs 1 counsel, which vas predicated on the use o f manipulative and epidemiologicallv unsound s ta tis tic a l practices--not sound science. The specific allegations forwarded to the SAB in the materials are easily rebutted by the record in the case. At tria l, the p la in tiffs 9 lawyer attempted to manipulate s ta tis tic a l data underlying the two mortality studies performed on the Nitro plant population. The Zack/Suskind study was peer-reviewed and published in the Journal o f Occupational Medicine in 1980* It was a mortality analysis o f the Nitre plant population acutely exposed to the po ten tia lly high levels of dioxin present in the 1949 runaway reaction at the fa c ility . The second study, referenced by p la in t iffs 9 counsel was a proportionate Mortality Ratio (PHR) study authored by lack and Gaffev which was performed at the same, plant but reviewed a cohort comprised of employees with long-term occupational' exposure to low levels o f dioxin from the production process, Accordingly, while there was po ten tia lly d ifferen t employees, levels of dioxin, and exposure periods. The studies were compr 1ed independent o f each other. At tria l the p la in tiffs sought to dispute the conclusions o f the studies by resorting to the epidemiological ly unsound practice o f retrospectively rearranging the study cohorts to achieve a desired re su lt. During the tria l the p la in t iffs ' lawyer combined the nine cancer deaths from the chronic exposure study performed by Zack and Gaffey with the other nine cancer deaths in the exposed cohort within the acute study compiled and published by Zack and Suskind. The selective construction o f a new cohort o f 18 cancer deaths was then compared by the lawyer with only the original 49 non-cancer deaths In the long-term exposure study by Zack/Gaffey. This sta tis tic a l reshuffling was argued at tria l by p la in t iffs ' lawyer as revealing for the f ir s t time on excess in cancer deaths which Monsanto had previously concealed, charges now transmitted to the EPA. Importantly, however, the merging o f the cohorts by the p la in tiffs 9 lawyer omitted the 23 non-cancer deaths in the Zaok/Suskind study which were essential to any combined comparison o f the two studies. This fatal s ta tis tic a l omission in the "re-analysis" by p la in tiffs ' counsel was not disclosed at tria l u n til Monsanto was able to o ffe r the clarification testimony o f its Medical Director, Dr. George Roush, and called the Kettering In sti.tu te9s Director, Dr. Raymond Suskind, to te s tify regarding his work. Counsel for p la in tiffs never called Drs. Zack or Gaffey as witnesses regarding their study. I f the p la in t iffs 9 lawyer had included the 23 non-cancer deaths se lec tive ly omitted in .his "re-analysis9*, a death rate o f 18 cancer deaths out o f 90 total deaths would have resulted and no excess cancer death rate would exist* (Sec the enclosed diagram depicting selective omission in p la in t iffs 9 counsels "re-analysis" and 'the actual r e s u lt.) (Acute or chronic, the 18 deaths were in fa ct cancer related. EPA*s own National Dioxin Strategy Tier 1 and 2 Accomolishments, technical support document. "Draft" January 1986. found 2 ,3 .7,8-TCDD contamination at the Nitro plant t o ...be pervasive, therefore c lo s s ific a tio n o f non-exnosed would he extremely d iffic u lt without assays, Gan you please clarify?) Contrary to the untrue accusations contained in the olaintiffs* aonellate brief. FROM NO RTH SHO RE HOMES INC 0 4 .0 3 .1 9 9 0 17:01 P. S it Dr* RoU$b did n0t that any o f the mortality studies at tfteAi.Cn? plant were fraudulent or scientW .ca.lly inaccurate. Enclosed with this correspondence is a copy o f a pertinent portion o f Dr. Roush's te stim o n y establishing the points outlined above. Sim ilarly, Dr. Suskind te s tifie d at the , rJS*'ndirl tbf accuracf o f the studies and that there was absolutely no e ffo rt to conceal^ evidence o f health effe c ts. A written o ffer o f proof, signed by Dr. Suskind, is enclosed with this correspondence and direct!v rebuts the accusations contained in the p la in tiffs ' b rie f, Examination o f Dr. Suskind's written o ffe r o f proof by any sc ie n tist familiar with the litera tu re regarding dioxin would make i t apparent that there was a constant a/irf broad e ffo rt by the p la in tiffs ' lawyer to mi&characlerize results of peer-reviewed s c ie n tific studies published by a wide variety o f authors, including Dr. Kimbrough. Of particular importance is the portion o f the offer of proof commencing at page 22 which provides the background and the data pertinent to rebut the accusation that the case showed that Dr. Suskind was\ "alleged to have fa lse ly stated that workers' nervous system and liver problems \ had disappeared by 1953." At tria l, Dr. Suskind te s tifie d that the AHA's conclusions that certain dioxin-related health effects cleared with time was based upon his experience in examining certain Nitre plant employees in 191.9 and then following their health over multi-year period. The offer of Dr. Suskind's publications on that point. The patently fa lse accusation by p l a i n t i f f s ' counsel that Dr* Suskind sought to conceal another physician *s findings o f psychoneuros is in exposed workers from the West Virginia Workmen's Compensation Commission / also covered in the writter; testimony o f Dr* Suskind regarding commencing at page 50. Repeatedly at the tria l Dr. Suskind te s tifie d that the commission knew and was told o f specific facts regarding the finding or "psychoneurosis" by another physician hut that the Commission rejected the suggestion that i t was related to the 1949 autoclave incident. The court record established that Dr. Suskind had appeared before the Workman's Compensation Commission 30 years earlier and had personal knowledge o f these facts. In short, the accusations by the p la in tiffs ' brief, which have been transmitted within the EPA, are untrue, contrary to history and the record at trial. Any c r itic a l reviewer o f the p l a i n t i f f s ' legal b rief should conclude that the allegations o f fraud arc not credible. rndeed, the allegation that the University o f Cincinnati falsi f i ed health studies regarding the mortality o f Nitro workers is belied by the fact that the conclusion is in reached in its peer-reviewed morbidity study on that population--that no long-term health effects other than chloracne appeared to be present--was shared by another totally independent study conducted at the same time on the same employee population by Dr. Irvine Solikoff o f Mt. Sinai School of Medicine, who was employed by the union to conduct that study. I t -is hoped that the EPA will correct any misapprehension within the Agency caused hv the receipt o f the p l a i n t i f f s ' appellate brief. Please advise i f you have any quest ions or require any further information. We arc very distur ed by the false charges being made against Monsanto and Dr. Suskind and will, or course, f ul l y cooperate with you in settin g the record straight. Sincerely, James N. Sanger Vice President rr______ __ a - i n-t.- -- <?*- P P * FROM MORTHSHORE HOMES INC 04.03.1990 17:02 Olympianditorialboafd Pftfttel*P.Mfeila, JamesH.Stevenson, managingeditor DfiG.Shdtltt,dHotifpagefeditor The Olympien, Tuesday, pril 3*1$0 7 Editorial ~~ ' ~ Must accept threat posed by chemicals The big question raised by the Center* for Disease Control (CDC) study 0X1 the incidence of cancer among Viet There was n need to waste a million dollars on the CDC study* The Veterans Administration to years ago presented nam veterans is why dbes the government still deny Agent Orange Is the culprit? Congress the results ofits Marine Mortality Study. This survey ofaUveterans who Could It be because the government al .Served In the I Corps theater in Vietnam lowed th deadly herbicide to continue to be :revealed a 110percent higher Incidence of used in this countzy for 10 years after it was ftbn-Hodgtdns lymphoma and a 58 percent banned in Vietnam? Or could it be the law Higher than normal lung cancer rate. suits being brought by Australian veterans ] who claim their health was destroyed in 4 < 1The CDC study hi a cost, but insigniflptfant teolhm oh th mountain of evidence . Vietnam by exposure to our Agent Orange? sw at exists as to the threat to Ufo posed by Whatever the reason, the CDC study will Vdioxin and other deadly chemicalsi only add to the mountains of misinformation ^ For inStanc, Mfitanto Co. is appealing surrounding Agent Orange. ` r ig id million damage Verdict handed down The CDC study admits th chance of because ofth e accidental spill of 19,000 gal- contacting non-Hodgkins lymphoma cancer - Ions of orthochlorophenol from a tank car in is SOpercent greater among Vietnam vt Sturgeon, Mo. Sixty-flv persons were ex rans than vtrans who Served elsewhere, posed. Theju ty based the Size of th award but denied Agent Orange had anything to do on the long-term threat to health. Or- with I t in foot, it gave no cause. thochorophenol is used to manufacture Agent Orange was a potent defoliant , nd M J* - th ingredients ofAgeht sprayed on the jungles of Vietnam. It con sisted of an equal mixture of 2,4 and - talkOrange. v 'We have had tob much and double- 2,4,5,T. The 5T formula has been banned talk. The time has come to admitwhat hai since 1985 because It contains deadly dioxin, , happened and is happening and take steps a known carcinogen. The D formula Is a - to Ming the sttuatfon under control. suspected dioxin carrier now under review. > The United States rred In th use of Agent Orange, erred in continuing its use after health threats were revealed and noW . is making a bad situationWdfse by refusing toaccept responsibility.