Tobacco Documents Online

LE OF CONTENTS Genera ................. A. The Secretary's Report ............ B. The Surgeon General's Report - 1967 ...... 6 ,. II. Specific Areas .................. i0 A. Smoking and Overall Mortality ......... 10 I. Measures of Exposure ........... ii ,i 2. Cessation of Smoking ........... 15 ~ B. Smoking and Overall Morbidity ......... 18 C. Smoking and Cardiovascular Disease ........ 19 1 Introduction • 19 2 Summary 20 3. The Status According to ~he Surgeon General 22 O a. Prospective Mortality Studies ..... 23 , b. Longshoremen Study ........... 25 c. Morbidity Study ...... "...... 26 d. Mechanisms ............... 28 e. Cerebrovascular Disease ........ 3.3 4. The Current Status ............. 34 a. Prospective Studies .......... 34

b. Retrospective Studies .......... 38 Multifactorial Disease ......... 41 d. Multivariate Analysis in General ..... 41 e. Multivariate Analyses and the Prospective mortality Studies ...... 44 f. Statistics Do Not Prove Cause ...... 45 Og. Twin Studies .............. 46 h Emotional Stress " 47 j. Predictors ............... 50 k. The Constitutional Hypothesis ...... 50 .... 5 Conclusion' 53 D. Smoking and Chronic BronchoPulmonaryDiseases (Non-Neoplastic) ................. 55 O Unjustified Broadening of 1964 Conclusion . • 55 1. 2. Difficulties of Diagnosis .......... 56 3. Four Prospective Mortality Studies ..... 57 4. Reliability of Mortality Statistics ..... Questioned ................. 58 5 Autopsy Studies " 59 6. Morbidity Studies .............. 59 7. H~redity and'Constitutional Factors .... 61

8. Occupational Exposures and Air Pollution .................. 62 .9. Experimental Evidence ............ 62 10. Summary ................... 63 Smoking and cancer - Highlights of Current Information ................... 65 1. Lung Cancer ................. 70 a. Mortaiity- General Background ..... 71 b. Vital Statistics Inconsistent with ~ Cigarette Theory 7~" c. Increase in Lung Cancer Mortality Pathologic Data ............. 81 d. Current Information on the Cigarette Smoke - Lung Cancer Association ..... 83 I. No Statistical Association Found... 8~" 2. No Relation in Case of Females . . . 84 3. Effect of Other Respiratory Illness .. including Tuberculosis ....... 86 4. No "Dose-Response" Shown ....... 88 5. Cessation of Smoking ........ 92 e. Current Information Concerning Suspected Carcinog4nic Agents in Tobacco Smoke. . . 94 f. The 1967 Report Understates the Evidence that Exposures other than to Cigarette Smoke appear to be related to Lung Cancer ................. I01 o O

g. Generally ............... 105 2. Oral Cancer .............. 106 3. Laryngeal Cancer .............. 107 4. Urinary. Bladder Cancer ........... 108 5. Esophageal Cancer • Conclusion ..

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RESPONSE TO HEW REPORT TO CONGRESS ON SMOKING AND HEALTH AND SURGEON GENERAL'S REPORT ON THE HEALTH • CONSEQUENCES OF SMOKING--1967 I. ~enerally. A. The Secretary's Report. Pursuant to the Federal Cigarette Labeling and Adver- rising Act Of 1965, Secretary Gardner has submitted a report to Congress concerning "current information on the health conse- quences of smoking" and "recommendations for ~egislation". The Secretary reports that the "principal thrust" of more than 2,000 recent research studies .completed and reported in "the biomedical -literature" has been to "strengthe~ the conclusions leached in 1964 and to determine more precisely the extent of death and dis- / ~~ords--at~_r!but~h~e tQ with th~emore careful word- in~-~n mortality and morbidity reports "showing d~a~san-~--~a~ili- ties statistically "associated" with cisarette smoking: (i) The Division o-----~ Vital Sta6is~i~s, in l~tin~ ~e~hs fr6m diseases sta- tistically asso6iated with smoking, warned that it had "no infor- matron" as to the proportion "actually caused" by.smoking (HEW Appropriations Hearings, 1968, Part.4~ p. 79); and (2) The National Center for Health Sta£istics pamphlet on "C~garette Smoking and }~ealth Characteristi6s," which presents statistics on disability, observed that data showing a statistical association "cannot es- tablish any existing relationship as a causal one" (p. 6~ When asked (see page 78 of the same volume on the H~ Hearings) ~y he referred to "at least 125,000 premature deaths, and maybe "as many as 300,000 deaths . . due to c~garette smoking", Surgeon General Stewart responded, "D~d I say 'due to'?" See Appendix A~ and the discussion at pages i0 and 18 .

The Secretary further reports (I] that the present warn- ing label on cigarette packages "is inadequate"~ (2) that the label has not"been a significant deterrent to cigarette smoking ("as amply show~ in the recent report of the Federal Trade Commission"). and "does not have any impact oh the many children and young people who are daily exposed to cigarette ad~ertisln~"~ and (3) that "the acc ulated evidence strongly suggests that the lower t.e 'tar: and nicotine content of cigarette smoke, the lowe~ the harmful effect" and that inf6rmation concerning content "of the smoke of each brand of cigarettes should be put before the smoker and the potential smoker" so the consumer would "thus be able to make an informed choice of product". : O The Secretary, based on the considerations stated, recom- mends (I) that the warning label on each package of cigarettes be ~strengthened to state more specifically and positively that ciga- rette smoking is a hazard to.health'~; (2) that the warning should be required in advertisements as well as on cigarette packages; and (3) that both the label and advertising should be required to contain information on the "tar" and nicotine levels "in the smoke of th~ cigarette" and the identity and quantity of such other sub- ~ O stances or agents "in the smoke as may sub-D£quently be found by the ~ O

appropriate Federal agency to c6ntribute to the health hazards of smoking. .The Sedreta~y attached a "Surgeon General's summary re- port", said to contain "detailed information on the health conse- quences of ~m£king", and referred to technical information, ~.ot att-.'~ed, which "will be available as an addendum to the Surgeon General's Report". . o • This response will demonstrate that "the gaps in knowl- edge identified in 1964"* in Smokinq and Health still exist, par- ticularly with respect to "the mechanism by: which ingredients in cigarette smoke induce harmful effects on t~e human body"* if, in fact, they do. .- .Until a "mechanism" has been identified, it is premature t5 assign a causative roleto cigarette smoking with respect to any disease and meaningless to speak in terms of "how much illness and mortality would be ave.rted by cessation of smoking".* ~t isequai- ly meaningless to modify the warning label imposed by Congress in- 1965 unless some scientific breakthrough has implicated cigarette *Secretary Gardner's statement, page 1

smoking by producing evidence fa@ more persuasive than that pre- • sented in the Surgeon General's 1967 report. In this respect it "" is certainly significant that the Secretary's statement, in deal- ing with the additional research efforts since 1964 refers in detail only to "epidemiological Information'--as to which the Surgeon Seneral's AdvisOry Committee had this to saM:. "Statistical Omethods cannot establish proof of a causal relationship in an association" (Smoking and Health, p.28). .The Secretary's recommendation that a warning be placed on cigarette gdvertising refers to "the recent rel~rt of the Federal Trade Commission". Since no data or other materigl supporting such a recommendation is incorporated in the HEW report, it will ~ot be dealt with further in this resl~nse. .The Secretary advances no reason why or how "tar", whic~ presented "a puzzling anomaly" (Smokin~ and Health, p. 33) in 1964, had suddenly become an indicator that would enable a smoker to make "an informed choice". Equally mysterious is the conclusion that the lower the.nicotine content of cigarette smoke, "th~ lower the harmful effect". If the "principal thrust" of recent studies has been to "strengthen the conclusions reached ~n 1964", then one ~

of ~he conclusions "strengthened" is the following: "(T)he chronic toxicity of nicotine in quantities • absorbed from smoking and other methods of tobacco use is very low and probably does nob represent an important health hazard." [Smoking and Health, p. 32) The "tar" and nicotine recommendation Is discussed hereafter commencing at page ii .

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.B. The Surgeon General's Report--1967. , The 1967 report discusses generaliy current information "on the health consequences of smokin~ and then presents "the major findings of research studies published ~n the past three to four years~ under the following six headings: O i. Smoking and Overall Mortality. 2.. Smokin~ and Overall ~0rbldity. B. Smoking and Cardiovascular Diseases. 4. Smoking and Chronic. Bronchopulmonary Diseases ' (Non-Neoplastic) . 5. Smoking and Cancer. 6. Other Conditions and Research Areas. O The introductory portion of the Surgeon General's 1967 r~port refers to earlier deaths and excess disability which "would not have occurred if those affected'had neve~ smoked" and attrib- .utes practically all of the earlier deaths from-lung cancer, a substantial portion of the earlier deaths from chronic broncho- pulmonary diseases and a portion of the earlier ~eaths of c~rdio- vascular origin to cigarette" smoking. The report observed that the conclusion that ~garette smokers have h~gher death rates ~hnn their

nonsmoking counterparts has "changed the emphasis of the present problem away from the question 'Does cigarette smoking cause d~s- ease?'" to more precise questions dealing with the degree of associ- ation, the portion of earl~ mortali£y and ~xcess disability caused by smoking, the portion that could be averted by the cessation or reduction of cigarette smoking and (in fourth and last place on the Surgeon General's iist) "What are the biomechanisms ~hereby these effects take place and what are the critical factors in these mechanisms?" ~ The "changed emphasis" away from the question of whether cigarette smoking causes disease and the placing of determination ~f biomechanisms in last place is proof that what many scientists who appeared before Congress in 19~5 feared'would happen has happen- ed. An offici~l position t~at cigarette smoking causes disease has ~een taken ind the primary mission of much "research" is to show additional statistical ~associatiqns" between cigarette smoking and certain diseases rather than to discover the basic biomehhanu isms actually responsible for such diseases. In this regard, a r~cent publication listing "gngoing research" in the.cigarette- health field reveals that a suHstantial part of the basic research

being done today is tobacco industry financed and administered e~ther by the American Medical Association or .t~e Council for To- .bacco Research (through its independent Scienti.fi~ Advisory Board); and that a substantial amount of Governmen£ supported "research" (over 1/3 of the total number of projects listed}" consists of "behavioral" studies, educational programs and anti-smoking propa- ganda.| " " • A review of th~ footnotes to the 1967 Surgeon General's summary report discloses no reference to any research demonstrating a "mechanism" by which smoking is proved to cause any human disease.* The references cited consist of the 1964 Surgeon General's Report, an unpublished smoking and health bibliography, two reports on mouse painting, fifteen statistical surveys and a report on ~iga- rette smoking "patterns". • The "gaps" in the case against cigarettes which were p~inted out after the 1964 Surgeon General's.report still exist. -Nothing contained in the 1967 summary report has eliminated or lessened them. Some of the miterial contained in the report, and considerable material~ich was not incorporated therein,, supports *Smoking itself canno£ be ~h~ cause of any disease since non- smog;ors develop all of the diseases statistically associated with smoking.

"highlights" such as the following rather than those selected by ,.the Surgeon General: . . " Several recent studies show no association between cardiovascular disease and cigarette smoking. The "consistent association" referred to in the Surgeon General's report in 1964 is no longer "consistent": Furthermore the recent literature contains stronq.evidence that ~rdio- ...... vascular dise&se is multifactorial i~ origin and that constitutional factors play a significant role in its cause. The epidemiologlcal data from which the association between lung cancer and cigarette ....smoking has been derived has been thrown into " question by recent large scale studies showing no association. Scientists have f~iledto discover any in- gredient in cigarette smoke responsible for -disease in man and no mechanism bywhich any human disease is Caused by cigarette smoking O has been demonstrated. ' These and other observationsare discussed in more deta~l in the following sections.

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