Tobacco Documents Online

1 At TO: Mr. David Hardy C lEMORANDUM - - - FROM: Sheldon C. Sommers, M.D. r_ >__ .~,E:T T~ CONFIDENTIALITY AGREEM ENT. You were interested to know my observations concerning the articles by Drs. Bassrond, Auerbadi, Messrs. Kirman and Garfinkel, published in Arch. Environ. Sealth, 1970, 21, 740 & 754. First, the articles are introduced by an Editor's Note. I vill not quote it, but merely point out that amon: over 40,000 medical articles included in my personal card file; I cannot remember one other such circumstance, where the editor introduced the article to the readers. The editor expresses an opinion as to the quality of the vork, and to the type of appraisal it receives. She, refers . to the "original versions", by which I gather these ..:. e not the originals published. Most medical journals only accept and publish original contributions. By this editor's note a shadow is cast unfortunately on what follows. The papers were submitted July 20 and accepted July 29. Dr. Auerbacb is on the editorial board of this journal. Taking these printed statements together, one concludes that duo proce. of editorial board review before icceptance was not followed. Due process in science as in law is basic, and violations for any reason are viewed with deep suspicion in the II.S. Second, in reference to the articles themselves, the first article deals partly vith "findings in the lung parenchyma". The difficulties and uncertainties of interpre- tation of pulmonary fibrosis, smphysema, etc., are veil known, and are referred to in an editorial by R.P. Sherwin in the same issue of the sase journal. If necessary, I am villin= to provide an analysis of these studies in detail, but believe this may be deferred. Third, in the second article, first author Auerbach, the title is "Pulmonary Neoplasms". In the material submitted originally to the news media it was inferred or stated these were all cancers. Nov in the formal publication the bronchiolo-alveolar tumors are divided intq noninvasive and invasive. If noninvasive broncho-alveolar tumors are considered benign, we can exclude 41 tumors in 29 dogs. This leaves 20 • CONFIDENTIAL: MINNESOTA TOBACCO LITIOATION CTR HN 014948

T'l ..i D,C:, .tE~1 r )Iad:E;,T Tu CONFIDENTIALITY AGREEMENT, A tumors in 12 dogs, per Table 1, which are te:med invasive bronchiolo-alveolar tumors. The authors point out the well known difficulty of distinguishing between multi- centric origin and extension of tumor. Also by considerable description one learns they find it difficult to establish whether the invasive tumors are cancer. It is never actually stated to be such. Invasion is one criterion of cancer, but there are others. Without the authors committing themselves that the bronchiolo-alvsolar tumors are cancer, overall or in certain cases, my opinion is that the reader is under no obligation to do so. Judged by the discussion they would like the reader to believe some wara adeno- carcinomas without the authors actually having-stated this. Such a situation is poor acianca and medicine, i.e. to influanc:a someone to believe something without actually stating it. If this reasoning and conclusion are acceptable, the nnobar of carcinomas is now reduced to 2 aaonf 86 do=s: Ior this there were pru s conferences and pages of print in the press and m.gasinu , and advice from the Cancer Society to the tobacco industry to change its ways, etc. , lourth, one comas to "squamous call bronchial carcinoma". Two instances are described, of microscopic sise, and studied by serial sections. Serial sectioning is only employed on very minute or dubious cases, or when the specimen is tiny. Points are made in the text about basement mamiranes, etc. PiSs. S-6 (latter has two parts), color pi=s. 1 62 show thas areas.. ltu text description of bronabns 'in Dog $55 a describes protrusion or sxtension, but not iavasion or cytologic atypia. The sin=le illustration haa a legend statin= "sarly invasion".. The plane of section of the bronchus is oblique and the d.monstrations of invasion or of carcinoma are not convincing. From the information given it is uncertain that carcinoma in situ, invasivQ carcinoma or any other naoplastic change, alone or together, vare present. The alteration is so aquivocal and tha justifying data so minimal that no emphasis on this lesion app urs justified. Another possible interpretation would be that it is a real microscopic carcinoma but so poorly described and illustrated that no wne als• caa make an independent confirmatory judgment. The other case, in do= 877 a, is described and illustrated in more detail. The description by itself is satisfactory for carcinoma, but the 4 figures instead of supporti CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION CTR HN 014"949

~ / actually dispel the impression. Besides tangential plane T , y~~~~ ; ~ _'-- ; CGNrNEyTlALITY AGREEMENT. of sections and apparent inclusion of bronchial gland ducts and branches in tangential planes, the individual cells, their grouping, the relation to the surface epithelium and stroma are not those usually found in carcinoma. Some pictures are cropped so that confirmation of tangential sectioning is not possible. Not enough cells except those clearly of the surface epitheli_ are shown to justify a classification of them as "squamous cells", even if invasion were accepted. One concludes this may be an early invasive carcinoma, but on the material supplied this remains uncertain. I suppose this is the one carcinoma that Dr. Shields Warren, cite: in acknovledgement, said he was shown. When in the discussion it is stated that these two carcinomas were "indistinguishable from many very small carcinomas we hava.obaerved" in bronchi of cigarette smokers, doubt is cast on the ::ility of the authors to recognize lung carcinoma in either species. , In sumnary one microscopic doubtful and one unsubstantiated carcinoma of bronchus are presented. My mamory is that referees from J.A.M.A. asked to see the original slides, and were refused. Those pathologists cited as seeing the material include two, Drs. Berg and Warren, who are not in the active practice of diagnostic pathology. Dr. Yesner presented a paper on cancer and smoking which a coauthor from Yale later disavowed. Drs. Garstl and Nielsan I do not know. No wll kaovn authoritative pathologist in the practice of cancer diagnosis is cited as supporting thi authors' conclusion. One would like to review the actual material. It should be pointed out that squamous call carcinoma of lung and elsewhere is one of the easiest and most typical carcinomas to recognize. It is the first type of carcinoma medical students usually learn about, because it is so simple to diagnose. Consequently it seems regrettable to read and see something so indefinite reported as carcinoma. Aespectfully submitted, Sheldon C. Somoaers, M.D. cc: Dr. Rockett, ~ Royt December 4, 197Q CONFIDENTIAL: MINNESOTA ~~ ~ +~ ~~ ~ TOBACCO LITIGATION ~ ~ ~ ~~''Z t..~ , ~ "t ...~ ..~ ~.+r