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. 1~~ai.Ai:CFi L.S.A. December 30, 1970 1 T0: 2•!r. D-~vid Hardy FRC{~: Dr. S. C. So=ers As you have requested, 7 am providing a separate analysis of the srticle by Drs. Hu=oni & Auerbach, Messrs. Kiraan and Garfint.el, Arch. " Lron Health, 19T0, 21 (Dec.) 740. This article deals with exF.rimental ne.ilyil, mortality and lung pareact>rzca, accordin,g to the subtitle. By the last they mean alveoli, although the ordinsry meaning of lung parenchyma includes bronchioles also. The experiaxntal design is s::pposed to utilize a reasonably satisfactory anima7l model, which they specify to have 3 characteristics. It is generally ag:ecd that does are not a satisfactory anirsal for chronic inhalatjorn exper:.ents, because it is s. cu.-nbersore, difficult and expensive affair, and because too small nt::bers can beF exposed to achieve a statistically signif.icant result. At the Gatliabu:g con,*erence where this vork vas partly presented, my understan3ing is that there was a nearly unuaimous agreement favoring the use of hamsters. The third specification given is that the animals demonstrate a dose-response relation bet::-een exposure and pathologic changes. Actually i this is a misuse of the term dose-response relationship, which is not accurate:y applicable to any research findings relatina smokins to disease, either in huar.ns or aniaaals. The reason is that doss-response refers to physiological or pcthophysio2oQical effects and not to lesions. One cannot speak properly+- of dose-re:ponse when one deals with peptic ulcers, various degenerations, hyperpluias and r,eaplcsms. It is not ay iatent to analyze the exprri mental design in ary It appears that the cigarettes without filters used were filter cigarettes from which the filters had been detachad. These cigarettes would thus not correspond to arrjtr.ina being smoked by anyone. Whatever tbi orisinal plan, it is stated under Cmaent that "we sere unable to obtain dop wry elose to the same ase and veight." This seeaa incrsdiblo. In atpr case the net result w.s that only 8 dogs riere in srouT. X (unexposed controls.) The sad fact is that there are too few controls in the experiment, and that under these circubstances it is difficult to accept aw conclusions. An experiment is only as good as the controls, which has been known lrom the time of Claude Bernard. The deaths of ariay.ls, suaoa.rized in Tables 2 & 3, inblude 9 with pullsonary infarcts, 4 with bronchapneumon_a and 2 with food aspiration. These 15 deaths exemplify the probletas that follow and complicate traeheostomy. Aside froe any other procedure, tracheost=q over a period of time produces an unhenlthy state, espscially in the res;irntort tract Probably no animal THIS DOCUMIEKT SUBJECT TO M%FIDEKnALM AGREEMENT. CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION CTR HN 014915 1

-.,. ..... . ~ I I . 1tY.Ja:AI:C~FT'L.~.~~. 2 w•o•,Lld have a norr..` life ea-pectr.nc,v with a pe:-na.-~ent tr actieostcuy. 7"he term cor pul,tianale used es anothar princ:pal cause of death is unusual. As they define it, this is not'a cause of death, but a cardiac response to various things. ti'hat they may nezn is uncErtain; perhaps it is right-sided cardiac failurc. As to tre aethod of analyzing the lung histologically, it is used only by Auerbac::, Lnd would not li:cely be employed, or interpreted siailnrljr, by a.~yone else. There are available standard methods for analysis of lunss, which were not used, and it is noa considered doubtful that-emptu•sema can be recognized Lnd grsded from 2x2 =. pieces r.T: lung. One item graded is thickness of pleura. This has no relation to emphysema, and its inclusion raises a question of relevance: Also, pad-like attachments are srething only found isportant b; Auerbachp so far as I know. Pulaonary fibrosis is not a col~ponent of eap2Wsema ordinarily, arsd thickness of arterioles (not arteries) has only a vague relation to enphysema. Finall,y, there are several typts of emphyse>wa, s.nd it is not stated which are or is involved. If there are bronchiolo-alveolar tunors, fibrosis or both, the erlphyseata may be of so called corr.pensatory type, Lnd irrelevant to the problem posed. Since no bac:-.ground inforaation is given, since the methods used axe inadequate, since the lung changes'raaa],yzed include others than espt>,}rseica, . and since the in•:estigators are authors of previously unccntirmed claims, and hence untru:.tx:-or~hy; it is not possible to accept their conclusions as fact. In reference to, eraphysera, eicperts in the field such as Drs. Sherwin, Spain, Thurlbeck Lnd Wyatt, may be able to give a more incisive analysis. See the editorial by Sherwin in the saate issue, ibid, 699. SCS*: is ) THIS DOCUMENT SUBJECT TO C4NFlDENTIAUTY AGREEMENT. CONrIDENTiAL: IAINNESUTA 7OBACCO LiTIGATION CTR HN 014952-