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I DISTRICT OF COLUMBIA ) ) CITY OF WASHINGTON ) Affidavit of Dr. Richard E. Kouri I, Richard E. Kouri, having been duly sworn hereby depose and say: 1. I hold a Ph.D. in Radiation Biology from the University of Tennessee. 2. I was employed by Microbiological Associates, Inc. from 1971 to 1984. 3. During my employment with Microbiological Associates, Inc., I was the Director of Research and the Principal Investigator for a variety of government and non-government contracts. 4. As a Principal Investigator, I was personally involved in a number of projects done under contract for the Council for Tobacco Research otherwise known as the CTR. 5. As part of my duties at Microbiological Associates, Inc., I worked with Dr. Carol Henry on a series of research contracts from CTR, some of which involved the exposure of mice to cigarette smoke by inhalation. 6. As initially planned, the research program was to have involved a series of experiments, the goal of which was to devise models both in mice and in-cultured cells to investigate the mechanism or mechanisms by which cigarette smoke causes biological changes (including cancers). 7. The inhalation project was only a part of a overall plan devised by Dr. John Kreisher, Dr. Carol Henry and myself to quantify the biological effects of cigarette smoke exposure. (See attached chart.) 8. '-' A key component of the overall research plan was the use of an analysis of aryl hydrocarbon hydroxylase (AHH) present before and after exposure to cigarette smoke in order to establish a method by which research data, collected as the result of experiments done on mice, could be correlated with the effect of cigarette smoke on humans. 9. Before the research program could be completed, the-CTRWlFaugh-its-lawyers informed us that the inhalation project would be terminated. 10. Subsequent to that termination, Dr. Carol Henry and I were requested to draft a Final Report on our research. C TR HN 043690

11. Dr. Henry and I were joined in our work by Dr. William Gardner of CTR and Mr. Tim , Finnegan, a lawyer representing CTR. 12. Mr. Finnegan and Dr. Gardner asked Dr. Henry and myself to include no opinion and little interpretation of data in the Final Report. 13. This was an unusual limita,tion on a scientific report. 14. It was my understanding that a mere compilation of data was all that was required, because the Final Report was to be used only as an internal document, i.e., it was not for publication. 15. While Dr. Henry and myself were primarily responsible for the drafting of the report, Mr. Finnegan influenced how it was phrased. \ 16. In my opinion, he was faced with data that said cigarette smoke was a weak carcinogen and he tried to figure out a way of saying that without saying it. 17. In 1984, I became aware that the CTR had published a book on the Microbiological Inhalation project. 18. 1 received a copy of the book in the mail after its publication. 19. Apparently the bulk of the book is the Final Report drafted by Carol Henry and myself under the direction of Dr. Gardner and Attorney Finnegan. ' 20. I was not involved in the preparation of of this book. 21. No authors are identified, either in the introduction to the book or elsewhere in the text. 22. Dr. Henry and I are identified as Project Directors in the 1984 publication. 23. ~ I have reviewed the Introduction to the book and do not agree with the statements made in the introduction by Dr. Charles Sommers. 24. While his statements may be technically true, as far as they go, they are seriously misleading because of the conclusions that are drawn and the failure to include the context in which the research was carried outf 25. I had absolutely no knowledge that the Final Report that Dr. Henry and I drafted would be used in this way. -2- , , CTR f f N 043-69,1.

] : 26. The use of the Final Report in this way was a perversion of the purpose of the report and is misleading. 27. 1 understand that the CTR and members of the tobacco industry have cited the Microbiological Associates Inhalation research results as support for the proposition that cigarette smoking does not cause lung cancer. As one of the primary researchers involved in the inhalatiQn projpcts, I_disagree with this representation. 28. While the results were just shy of the usual 95% confidence level, the overall data established a strong case that cigarette smoke is a week carcinogen for mouse lung. The sensitivity of mice to the high nicotine levels from the reference cigarette that was used in this study likely confounded the analysis of the cancer data. 29. It was our intention and plan to replicate the inhalation work with low nicotine cigarettes in order to eliminate the nicotine poisoning problem. However, this follow up research was not funded. 30. In July of 1986 an article entitled "Chronic Inhalation Studies in Mice. 11 Effects of Long Term Exposure to 2R1 Cigarette Smoke on (C57b1/Cum X3H/AnfCom) F, Mice" was published in the JNC1 by Dr. Carol Henry and me. Attorney Tim Finnegan reviewed and edited the article. Mr. Finnegan asked strongly that we limit our discussion and interpretation of the data to just the mouse model. 31. My contact with CTR for approximately 7 years was Dr. John Kreisher. 32. In 1978, Dr. Kreisher was dismissed from CTR. 33. When Dr. Kreisher left CTR, the way in which we communicated with CTR changed drastically. 34. Dr. Henry and I made sure we would travel to New York to visit with CTR staff and bring them up-to-date on our work. This was done every month. ~r. 35. In the latter part of the contract, in addition to our visits to CTR, Dr. Vincent Lisanti and Attorney Tim Finnegan began to do regular site visits. 36. The type of work done by Microbiological Associates, Inc. also changed. Research became less focused on answering the questions posed by the Stages of Carcinogenesis Chart. Research was not designed to resolve any of the questions regarding hm cigarette smoke caused cancer. - 37. Work on chemical transformation, carcinogenesis, and mutagenicesis areas of research related directly to the connection between the human experience with cigarette smoke and -3- CTR HN 043692

] the animal experiments being done at Microbiological Associates, Inc. was terminated in mid to late 1978. 38. • In my opinion, the termination of these areas of research and the failure of the CTR to continue the inhalation research project as planned may have been good business decisions for the CTR and its tobacco industry members, b5,these decisions were not good science. . ,_ . Sworn to and subscribed before me this j~ day of 7~_, 1997. A Notary Public My Commissi KOURI.AFF Kami `1GfME RK3iARD E. SCOTT Y"UC DISTRICT OF COLUMBIA 1miu'an EViros Ckfobsr 31, 1999 -4- ) CTR t-IN 04~-49ca-4

1 . , STAGES IN CARCINOGENESIS IN ITIATION -BIOCHEMICAL PROMOTION-~-- ~ ~f ~ Cf LL.ULAR PROMOTION '-' . I FactM fwx~. Dr. R. E. Kourl Dr. J. H. Kreis6er Dr. C. J+ Henry