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4 HK31142oa, ~ EXHIXIT y;• .~tr~S• /C . a 2 f~ STATEMENT 0! SHELDON C. S0l9MER5, M.D. IIEFORE THE CONSUMER SUBCOMMITTEE OF THE U.S. SENATE INTERSTATE COlQtERCE COMMITTEE My name is Sheldon C. Sommers. I am a physician, specializinq in Pathology, Director of Laboratories, Lenox Hill Hospital, New York, N.Y. My academic appoint<nents are Clinical Professor of Patholoqy. Columbia University Colleqe of Physicians i Surgeons, and Clinical Professor of Pathology, Universirj of Southern California School of Medicine. In April 1969, I appeared as a Mitnss b.tore the U.S. House of Representatives Committe>• that h.ld hearings / concerning cigarette labelinq and advertising. My curriculum vitae and publications are appended in the record of these hearinqs, publication Serial - No. 91-12, 1969, pp. 1085-1093. Updated publications now number 235, and there are new cosaitte., consultative and editorial responsibilities. For the past five years I have served on the Scientific Advisory Doard, The Council for Tobacco Research, of which I am currently chairsan. For nearly three years I have been research Director. The Council for Tobacco Research - U.S.A., is funded by tobacco compusia with about $2.5 million unually. t e This is expended for research grants and contracts awarded on the basis of decisions.ot the Scientific Advisory soard, which considers the competitive scientific merit and relevance of the prooosals received to smokinq and health problems. The soard includes distinguished authorities in carcinoqenesis, Ors. Andervont and Huebnert in heart disease, Dr. Sings in chronic respiratory disease, Dr. Looslir and in othar scientific disciplines. Our efforts are directed to helping fund investigators who may discover the causes and mechanisms of diseases claimed related to smokinq tobacco, in particular cancer, chronic respiratory diseases and coronary heart disease. I wish briefly to comeeent on proqress in, THIS DOCUMENT SUBIECT TO and the present status of, research in this area. MNflDEHTIAUTy AGREEME)IT. k CTR H~~ 01~~~~ ~

I t 2 HK7114 2 00 a2 ?irst, however, as a citizen, I wish to point out something serious that has happansd in the way our government deals with our people. This consists of selective release to the press and media of certain technical information and conclusions, while withholding the evidence and sources of the material. One example is "The Health Consequences of Smokinq...1971,' which I received in printed form only after the press release of the 1972 YeQort. Sweeping statements about carbon monoxide in the 1972 report are not substantiated by the detailed exposition in th• basic docustent, vhich is only obtainable in typescript copies passed hand to hand, like the "sapiski" in Russia. sudg.tary restrictions, inertia and inefficiency cannot excuse a one year delay in receipt of this governmental publication supposedly sent to all physicians. Other examples may be cited, such as a press release concerning oral hypoqlyc:mic drugs for diabetics based on an unpublished and unavailable research study later reported as not above / valid criticisms. Diabetic sptcialists have used petition to the government as their only available m.ans of redress, since various appointed officers, committees. cossiissions, bureaus, etc., ats apparently extralegal or supraleqal. In a technoloqie age to announce aNdical and other non-military discoveries and decisions, keapinq restricted'or secret the basic data and their source is dangerously nondemocratic. Where are th. traditional ehacks and balances? where is the informed eleetorats or the informed legislator? Now to consider problem of smoking and health. In respect to lung cancer, a foeus of attention, the newly published standard American textbook of pathology, 6th edition, W.A.D. Anderson F•ditor, 1971, Mosby Co., St. Louis includes this statement by Dr. Max Millard, page 964s "The close relationship between certain typsof lung carcinomas and cigaretts smokin has been made well known, as has the lesser relationship to cigar and pipe smoking. whether or not THIS DOCUMENT SUBJECT To CONflDENTIAUTY AGREEMENT, i CTR HN 014922B

+ 3 NK211-112C33 a cause-and-effect relationship has been proved is a bl.nd'of logical, statistical and emotional arqument." Note the omission of inention of biological evidence or scientific proof. I leave aside the emotional involvement. Presumab:y by logical arqvment is meant the idea that smoking ought to be harmful, whether it is jo proved or not, originated by King James, and a moot question ever since. There remains the statistical evidence to consider. Association does not mean causation, and in 1940 on this basis the main cause of lung cancer was considered to be tuberculosis. Statistical mathematics so far devqloped deal successfully largely with random populations. Since smokers and nonsmokers are self-selected, no randomized groups sxist to compars. The application of inappropriate mathematical formulas thus cannot provide a valid result when smokers and nonsmokers are compared on a one-to-one basis. The errors in death certificate diagnoses used in most such studies are estimated at 2S to over 50 percent. Bias ~ and the missionary zeal of some investigators, who have refused to release their data for reviw, cast a pall on their conclusions. The ftyal College of Physicians report, available in 1971, considered statistical evidence of the increased disease and death'ratss among British doctors who smoked cigarettes as the strongest indication of their harmfulness. In Lancet, the current January 1972 issue, is an article by Dr. Carl Seltzer, Harvard School of Public Health, pointing out critical defects in these comparisons and conclusions. Last year's strongest statistical evidence appears destroyed this year. I salute the editorial board of Lancet for this example of Eoqlish fair play. One doubts that Dr. Seltzer would have been allowed to publish this paper in.a comparable U.S. medical journal. The key point is that in a new and uncertain scientific discipline, still developing its techniques and a better iunderstandinq of the biases involved, neither reliance nor decisions based on the statistical epidemiology of lung cancer appear warranted. THIS DOCUMENT SUBJECT TO CONFIDENTIAUTY AGREEMENT. CTR HN 014929

k ! 4 N it31 1 4 223-i Lung cancer research in animals has progressed little in two years. We still search for a reliable animal model, inhaling whole fresh smoke in a natural way approximating human smoking. The reports of cancer in tracheotomized dogs appear generally discredited. The importance of genetics and the viral oncoqene in lung tumiors is increasing, based on findings in mice, hamsters and in tissue culture. Genetically pure cell lines exposed both to an oncogenic virus and a ehesiical irritant transform in tissue culture into n.oplastie-typo cells, where neither agent alone produces transformation. The cells are of connective tissues, the tumors are sarcomas and there is no current relevanee to human carcinomas which are eosqosed of epithelial cells. However, the astiaiinq technical advances in virology in the past two years provide hope that similar viral genes in epithelial cells may "turn on" and initiate some aniaal or hueoan carcinomas. i Until at least this is achieved it is premature to implicate or to exclude various chemical substances, including whole tobacco smoke condensate (so-called "tar") or its fractions. Nicotine of course is not carcinogenic. por brevity, other less spectacular advances in cancer research are omitted. In•respect to chronic pulmonary diseases, particularly emphysema and bronchitis, a slow advance continues in the techniques of demonstrating clinical, physiologic and pathologic indicators of these conditions. So long as patholoqic emphysema means something different, reqarding its presence, type and extent microscopically to each of 9 different experts in the field, as reported recently, a consensus concerning causes and developmental stages cannot be expected. Important new information has ease from sputum cytology. Tissue digesting enzymes affecting the lung are genetically controlled and explain same emphysema. The curious absence of emphysema in most Negroes, regardless of anvironm.ntal and other factors, deserves more inquiry. To blame cigarette smoke, condensate (so-called "tar") or nicotine for bronchitis•emphyssma is simply to accept a delusion in our currently early sta3e of understanding t~~fiSe DuGUMENToIIBJECT TO LAtIflDENTU1lJTY_ AGREEMENI. . C{y(ti. \ tN 014930