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365 Statement of Dr. Victor Buhler My name is Victor Buhler and I am a pathologist living in Kansas City, Missouri. I am certified by the American Board of Pathology in both pathologic anatomy and clinical pathology. I have held faculty appointments at the University of Kansas School of Medicine and the University of Missouri-Kansas City School of Medicine. I have served as the President of the College of American Pathologists, the Missouri State Medical Association, the Missouri Society of Pathologists and the Kansas City Society of Pathologists. I am a Fellow of the American Society of Clinical Pathologists, the American College of Physicians, the American College of Pathologists, and a member of the International Academy of Pathology and the American Association for the Advancement of Science. I participated upon invitation by President Johnson in the White House Conference on Health in 1965. At the present time, I am associated with a group of pathologists serving one major hospital and several community hospitals in the Kansas City area, with primary responsibility for the Liberty Hospital, Liberty, Missouri. I have become familiar over the years with many of the articles cited in the various Surgeon General's reports on smoking and health and with the general medice this subject. I testified before the Foreign Commerce in 1969 in regard to cigarette labeling and advertising.. i Committee that my knowledge of the mec investigations and my laboratory expe: conviction that neither cigarette smo: agent has been shown to be the cause have seen no research reports in the : would change that view. I am pleased give you my views on the present legi: in S. 1929 and H.R. 4957. I am most disturbed by the these legislative proposals that ciga cause of lung cancer. Such a stateme supportable by the pathological and c made during my practice, nor by my re I am disturbed to see such findings i because I believe it is deceptive and and the medical community. The press of cancer and other chronic diseases should be. The problem, however, is great temptation to seize upon easy a to realize that objectivity is,vitall progress. The cause or causes of lur Congressional finding to the contrary -2-

1 a A 365 and health and with the general medical literature pertaining to this subject. I.testified before the Committee on Interstate and Foreign Commerce in 1969 in regard to proposed legislation concerning cigarette labeling and advertising. At that time, I told the Committee that my knowledge of the medical literature, my own investigations and my laboratory experience established "my firm conviction that neither cigarette smoking nor any other etiological agent has been shown to be the cause of cancer of the lung." I have seen no research reports in the intervening 13 years which would change that view. I am pleased to have the opportunity to give you my views on the present legislative proposals embodied in S. 1929 and H.R. 4957. I am most disturbed by the finding included in both of these legislative proposals that cigarette smoking is the major cause of lung cancer. Such a statement is, in my view, not supportable by the pathological and clinical observations I have made during my practice, nor by my review of the medical literature. I am disturbed to see such findings in proposed federal legislation because I believe it is deceptive and misleading to the public and the medical community. The pressure to find causes and cures of cancer and other chronic diseases is considerable, and it should be. The problem, however, is that this pressure creates great temptation to seize upon easy answers. It is always important to realize that objectivity is vitally necessary for scientific progress. The cause or causes of lung cancer are unknown, and a Congressional finding to the contrary does not alter that situation. -2- I

366 Our only hope for progress in the fight against this dread disease is in innovative medical research, not legislative pronouncements. My view that cigarette smoking has not been proven to be a cause of lung cancer is based on my personal knowledge of the sources for the epidemiological evidence frequently used to support this theory. Epidemiological studies, for the most part, are based on mortality data derived from statements of physicians or others who sign death certificates. in approximately 80 percent of deaths, no post-mortem examinations are done to verify the information on the death certificate regarding the primary or underlying causes of death. Even when autopsies are performed, the results often are not available until after the death cer- tificates have been completed. The recorded causes of death, then, are primarily based on the clinical diagnoses, and it has been my experience as a practicing pathologist that these are frequently incorrect. If death certificates reflected the results of completed autopsies, the statistics would have a much higher degree of validity. At the present time it must be understood that 80 percent or more of all death certificates cannot be considered as having been scientifically validated. Consequently, I have grave doubts about the statistical associations which have been derived from data which is subject to serious flaws. --In addition, the data in statistical studies of lung cancer do not distinguish between primary lung cancer and secondary lung cancer. Primary lung cancer is a malignant tumor originating -3- 367 in the lung. Secondary lung cancer, o: cancer that has spread to the lung froi have all too frequently found in my ow: considered as primary in the lung are from cancerous growths in other parts < One of the reasons why prima frequently diagnosed when it is not pr depend primarily on chest x-rays as th it. In this regard, it should be note fewer problems in interpretation than : or part of the body except the skeleta the air in the lungs provides an excel that disease states are more readily d that it is easier to observe on x-ray rather than, for example, the liver. cannot always tell from an x-ray wheth the lung is a nonmalignant or malignan whether or not it originated in the lu There are of course, technic diagnosing lung cancer. Biopsy and sc (CAT scan), two other routinely used rr for distinguishing between secondary e should be stressed that primary lung c secondary tumors arising from other oz sufficient frequency to challenge the ~ W ~ a ~ c~

367 in the lung. Secondary lung cancer, often called metastatic, is cancer that has spread to the lung from another body site. I have all too frequently found in my own work that tumors clinically considered as primary in the lung are often metastatic and result from cancerous growths in other parts of the body. One of the reasons why primary lung cancer may be frequently diagnosed when it is not present is that physicians depend primarily on chest x-rays as the technique for diagnosing it. In this regard, it should be noted that chest x-rays present fewer problems in interpretation than x-rays of any other organ or part of the body except the skeletal system. This is because the air in the lungs provides an excellent contrast medium so that disease states are more readily detected. We find, therefore, that it is easier to observe on x-ray an abnormality in the chest rather than, for example, the liver. Even then, however, one cannot always tell from an x-ray whether an area of density in the lung is a nonmalignant or malignant growth, and if malignant, whether or not it originated in the lung. There are of course, techniques other than x-rays for diagnosing lung cancer. Biopsy and sophisticated scanning techniques (CAT scan), two other routinely used methods, do not always allow for distinguishing between secondary and primary tumors. It should be stressed that primary lung cancer is simulated by secondary tumors arising from other organs of the body with sufficient frequency to challenge the diagnostic accuracy of many -4-

deaths certified as primary lung cancer without autopsy exclusion In my judgement, the failure of epidemiological studies to distinguish between primary and secondary lung cancer in their statistical analyses raises serious questions about causal inter- pretations of statistical associations. Some advocates of the smoking causation hypothesis have said that lung tissue from smokers exhibits certain abnormalities that they describe as "pre-cancerous." They conclude then that cigarette smoking causes these changes which eventually will lead to lung cancer. Let me say first of all that based on my examina- tion of thousands of lungs in microscopic detail that no one can determine whether or not a lesion described as "pre-cancerous" will progress into cancer. .Metaplasia (changes of one type of tissue to another type), hyperplasia (increases in cell numbers), and dysplasia (atypical cytologic changes in cells) can be seen in lungs of both smokers and non-smokers. All of these kinds of changes are rather common and should not be considered as pre-cancerous. In fact, the weight of scientific evidence is that these lesions will not progre'ss to cancer. Metaplasia, common in older individuals, occurs frequently in the trachea or windpipe, and yet tracheal cancer is extremely rare. Any study of autopsy cases that suggests that metaplasia, hyperplasia, or dysplasia provides evidence that 369 smoking leads to lung cancer oversteps s my own experience, I cannot confirm that tissue changes in the lung occur more fr in non-smokers. Certainly there are smo non-smokers with changes. As a pathologist, I find the a: lesions to indict smoking as a cause of ] vincing and indeed inconsistent with my c I might add that, contrary to t often hears, it is impossible for the pat from both gross and microscopic examinati the person is a smoker or. a non-smoker. I am equally unconvinced by the animal experimentation. As the Congressic twice described to Congressman Tim Lee Cas nesses in one of the few inhalation experi produced cancer -- the Auerbach beagles st suffered from severe design defects, and t published with the article would not permi reach the conclusions stated by the author. Congressman Carter the essential failure o: tion experiments to induce lung cancer in z is still valid today: no inhalation studie tobacco smoke inhalation causes lung cancer -6-

369 smoking leads to lung cancer oversteps scientific bounds. Through my own experience, I cannot confirm that significant cell or tissue changes in the lung occur more frequently in smokers than in non-smokers. Certainly there are smokers without changes, and non-smokers with changes. As a pathologist, I find the arguments on "pre-cancerous" lesions to indict smoking as a cause of lung cancer to be uncon- vincing and indeed inconsistent with my own clinical observations. I might add that, contrary to the reports that one often hears, it is impossible for the pathologist to determine from both gross and microscopic examination of lung tissue whether the person is a smoker or. a non-smoker. I am equally unconvinced by the evidence provided by animal experimentation. As the Congresaional Record shows, I twice described to Congressman Tim Lee Carter the critical weak- r.esses in one of the few inhalation experiments that have supposedly produced cancer -- the Auerbach beagles study. That experiment suffered from severe design defects, and the photomicrographs published with the article would not permit most pathologists to reach the conclusions stated by the authors. I described to Congressman Carter the essential failure of tobacco smoke inhala- tion experiments to induce lung cancer in animals. That comment is still valid today: no inhalation studies have shown that tobacco smoke inhalation causes lung cancer. Other experimental -6- y I 8

methods of exposure, such as skin painting, fail to realistically approximate actual human exposure, so that the results of these experimental models must be viewed with suspicion. Another important aspect of the smoking and lung cancer question involves the histological (cell type) classification of tumors. Some have suggested that the newer cigarettes, generally those with lower tar and nicotine yields, are responsible for the emergence of different frequencies of the various cell types. Squamous cell carcinoma is the type of cancer that has generally .been associated with cigarette smoking. It is less frequently found in non-smokers and in women, for reasons that are not yet known. Recently, a few reports have suggested that the relative frequency of squamous cell cancer is decreasing, while that of adenocarcinoma, the type formerly found more commonly in women and non-smokers, may be increasing. I find the interpretation that these new patterns are caused by recent changes in cigarette manufacture to be highly questionable. First, I believe that the few isolated reports lack sufficient information about such rudimentary factors as nutritional status, occupational.exposure, or ethnic background. Consequently, they do not provide, in my view, a reliable measure of the changes in the general population. Further, of a more technical nature, but of cardinal importance to the pathologist, is the cellular variation produced -7- 37 by the different methods of specimen storage, and staining techniques. Ir. frequency of certain cell types will the specimens; sputum cytology, for e results from specimens taken at surge from those taken at autopsy. Most important of all, howev seems to be virtually no solid evidenc these reported changes. Until more ri are applied, this change in cell type remains unexplainable and of unknown s: Based on my years of experier my reviews of the smoking and health li strongly with the proposed Congressiona smoking is the major cause of lung canc -a-

371 by the different methods of specimen procurement, fixation, storage, and staining techniques. In addition, the reported frequency of certain cell types will depend upon the source of the specimens; sputum cytology, for example, yields very different results from specimens taken at surgery, which in turn differ from those taken at autopsy. Most important of all, however, is the fact that there seems to be virtually no solid evidence to link cigarettes with these reported changes. Until more rigorous scientific standards are applied, this change in cell type frequency, if it is real, remains unexplainable and of unknown significance. Based on my years of experience as a pathologist and on my reviews of the smoking and health literature, I must disagree strongly with the proposed Congressional finding that cigarette smoking is the major cause of lung cancer. - Victor B. Buhler, M.D. -8-