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(B&W) PROTECTED BY MINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER C C. V • PLAINTIFFS' EXHIBfT ~ DATE 5~' L-=2 - RICHARD G. STIREWALT REG. PROF. COURT REPORTER I would imagine that the industry could be asked what it is going to do following the Auerbach publication. . Is it possible to adopt the stance that "the work is significant and important; and the industry will sponsor a research project (in which Auerbach collaborates) aimed at repeating the experiment•under statistical control to determine the significance of the rate of Incidence of invasive squamous carcinoma in relation to dosage, etc." (This type of experiment needs to be done so that.the industry can become aware of how it might have to change its products, as inhalation techniques and experimental procedures become more sophisticated and possibly produce even more damaging results. ) .J C T R H N 0 43 If"-> 6 8

(N (B&W) PROTECTED BY MINNESOTA TOBACCO LTIIGATTON PROTECTIVE ORDER AIIERBACH /HAMMOND PA3ER GENERAL 1. ' Although open to criticism on several cor.nts,, the general standard of the paper is good. I am of the view that this shows it is now ' possible to produce tumors in the respiratory system of an animal by direct inhalation. It can, however, be argued that the animal used is, to some degree, susceptible to malignancy, and the incidence and sharp rise in tumor production after day 8?5 is of some significance. 2. The general statistical design of the experiment is open to criticism, but I do not think that this criticism will drastically alter the conclusion. ^ Relating the tumor type in the dog with that in the human Is open to query and it would seem pertinent for a pathologist from C. T. R. QDr. Sommers) to visit Auerbach for discussion on the paper anil the pathology. If possible, B&W should also visit Auerbach to see the smokingprocedures, and absorb some understanding of animal and . human tumor pathology. 3. 1 do quarrel with the section, starting page 8, in which Hammond draws. relation between the dog results and incidence In humans. This is prejudiced thinking and is unsound. Looking at the tabulated results, two areas which are dangerous are incidence of emphysema after smoking; the controls are free so it is reasonable to conclude that smoking brings on an emphysemic condition. A similar conclusion can be drawn from the It arteriolic thickening results. 4. This paper Tnust affect the thinking within B&W, and would seem to me to relegate stances on good or bad statistical evaluations to second place. Indeed, this publication could reverse the huped-for consequence of something like Project Truth. 5. The orders of difference between filtered, non-filtered, light and C~ heavy smoking are difficult to comment on without sight of slides, etc. ~ The trends are interesting, and further work is, now very important, ~ : since by inference the incidence of fibrotic, emphysemic and tumor- p .. genic conditions are dependent on the type of smoke presented. This W-' is good news in the long term. -, ~ C1 CTR 1"IN 04,3269E

(B&W) PROTECTED BY NIINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER Z - • • . C . DISCUSSION OF THE PAPER ~. . . • • .~ - . ':' ,(a) The general control on the choice of animal, its history - genetically, . bacteriologically and immunologically - Is poor. ' Indeed, it mi& be -• argued that it is a cancer-susceptible strain; this is borne out by the incidence,and sharp rise in the tumor•production, etc. after 875 dogs; Auerbach almost commits himself to a similar conclusion on the first '~r- - page of his paper. :: . . .. . :' . r feres with _~ - , to) The tracheostoma is a stress process, and possibly inte mucus-flow conditions, making the animal more susceptible to tlssue l t bi i h t d l '' L consequen o og ca ion an e anges. ta .~ . •~; ~ . . ~ . . • . .• ~ .. . . • (c) it would have been interesting to see the effect of a non-toxdc aerosol administered in the same way. There are suggestions froa cther work; oke mi diti simila hi v d b s ht ; • to th t t i t g y w . a..;: ory con ons r ose ac e ra e ha resp " have been obtained. _ (d) The method of smoke input is dissimilar to humans, who have the opportunity for buccal and mucus clearance. The dogs do not; hence a biased condition similar to that of Saffiotti who used localizing :technique. (e) There is little description of the smoking machine and method of smoke '; input. This is one area where a visit to Auerbach might be profitable. (f) The design of the experiment is poor, e, g. , the choice of control as being the higher-weight animals; the number of controls should equal the treatment numbers. In fact, statistically, the whole experiment should be up-numbered. The decision to sacrifice all groups when one group has 50yo mortality I do not understand _ , . (g) The percentage values drawn from subjective aisessment of studie's of emphysema, fibrosis, etc., would seem to me to be highly suspect. . In this area I would guess that pathologists ~irould disagree, since it is :~~~~,'~;i' -well-known that reference pathological examination is rarely carried `~.~4;;1 ;. out. rd!' (h) All the above leads me to the viewthat correlation with the human is still way off; but I accept that significant tumorogenic conditions following inhalation has been achieved. . m: CD C TR HN 04 -3 ~ ~ 0