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vital statistics

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This document was apparently discovered by Woody Wilner and was brought to my attention by Ron Davis. It was used as a trial exhibit in the Broin case (the Florida case of the 50,000 non-smoking flight attendants who became ill from breathing secondhand smoke in aircraft cabins). It was also used in several state trials. The document begins with a chilling acknowledgement of the death rate caused by tobacco use, and then offers page after page of tutorial explanations about how to throw doubt on the powerful and frightening statistical association between the death rate from certain diseases and tobacco use. The latter part of the document discuss the politics of the association between smoking and disease in Britain, where the promotion of a 1962 report on Smoking and Health by the Royal College of Physicians was "skillfully planned, and it had great effect. Within a week of publication of the report....the Minister of Health announced: 'The government certainly accepts that the Report demonstrates authoritatively and crushingly the connection between smoking and lung cancer and the more general hazards of smoking.' " This was a milestone against the industry in Britain. Title: Smoking and Health: The Present Position in the U.K. and How it Came About Type of Document: Report [confidential] Date: 19690620 Author: N/A Recipient: N/A Page count: 23 Site: Philip Morris document site http://www.pmdocs.com/ Bates No. 1000215062/5085 URL: http://www.pmdocs.com/getallimg.asp'DOCID=1000215063/5085 Quote (from the beginning of the document): The Present Position: the Main Evidence Against Smoking We all like to think of ourselves as men who have the moral strength to face the facts, even if they are unpleasant facts. So I am going to start by asking you to face certain facts, certain vital statistics. When I mention the words "vital statistics," some of my friends immediately think of figures like 38-24-36. The vital statistics I would like you to bear in mind are 7, 57, 139 and 227. There is no glamour in these figures. They are the death rates per 100,000 per year from cancer of the lung of men who were non-smokers (they are the 7), men who smoked 1-14 cigarettes daily (they are the 57), men who smoked 15-24 cigarettes daily (they are the 139) and men who smoked 25 or more cigarettes daily (they are the 227). These figures are all included in table 1 which you have before you. Those four vital statistics are basically the reason why we are here tonight. They are the reason why the tobacco manufacturers in this country have spent over five million pounds to date on smoking and health research through the Tobacco Research Council, and perhaps as much again on their own research. These vital statistics are really vital. They threaten the life of the tobacco industry in every country of the world.

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• 3 4RIQTLY CONFIDENTIAL ..r . f°j,iiY•+l _ 'U,-~-•~.~~~ 'f ~' .• G 665 a`~.~• E; 7 ,,,,::, -~~L"i::c•. y~. ~~~M ;a- .`n • :•~~~~."'y ~• t'" Smoking and Health: the Present Position in the U. K. , and How it came about' I , z•:~ ;The Present Position: the Main Evidence against Smoking We all like~to think of ourselves as men who have the moral strength to face facts, even if they are unpleasant facts. So I am going to start by asking you to tace certain facts, certain vital .::. .• .-., .<'.:.;.t :.,.,.... :... " : _.. ~;',,, . .. . . . . .....- ...,'. .'.. . . . • /i . statistics. llhen.I mention the words "vital statistics", some of my friends immediately think of figures like 38 - 24 - 36. The ~vital statistics I would like you to bear in_mind are 7, 57, 139 and 227.-There is no glamour about these figures. They are the death rates per 100,000 per year from cancer of the lung of men who were non-smokers (they are the 7), men who smoked l- 14 cigarettes daily (they are the 57), men who smoked 15 - 24 cigarettes daily (they are the 139) and men who smoked 25 or more cigarettes daily (they are the 227). These figures are all included in table 1 which you have before you. .., . . . .... ,-.. Thes@ fonrnitalstatistics are basically the reason why we are here to-night. They are the reason why the tobacco manufacturers in this country have spent over £5m. to date on smoking and health research through the Tobacco Research Council, and perhaps as much ~ again on their ownresearch. These vital statistics are really vital. They threaten the life of the tobacco industry in every country of ,.the world. , g p p • ;.~ cigar smokers, for men who smoked other products as well as cigarettes. ~ - since the figures I have quoted refer to smokers of cigarettes only While the four figures which I have given you are the ones that really matter I have also included in table 1 fi ures for i e and - and for men who have given up cigarette smoking. Table 1 also includes the corresponding figures for the death rates for two other diseases - bronchitis and coronary thrombosis. Since we are going to consider If these figures are really valid, it is necessary to describe how these vital statistics were arrived at. They were the results of an epidemiological survey. - 1 -
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..._.,t.. - ~- . ;!',Epidemiology" simply means the science of diseases found in a large . number of people. Epidemiology is a particular form of applied the epidemiological studies of smoking and other diseases are smoking and lung cancer, and they all reached similar conclusions. smoking and disease have now been carried out in many country of the world. There are well over 50 good quality epldemlological studies of statistics. A very large number of epidemiological studies of added in, the total runs into hundreds. But the total is not important, One good, conclusive study is enough - un2ortunately. These epidemiological studies of smoking and disease were of two called "prospective" studies. The retrospective studies were the kinds - what were called "retrospective" studies and what were first to be carried out, partly because they are simpler and partly investigated). In addition, an approximately equal number of patients who already have lung cancer (or whatever disease is being retrospective study is that the statisticians select a number of because they give results immediately. The procedure in a = patients is selected who have diseases which could not be attributed to the factors that might have caused the disease being investigated. Such people, for example, might have been involved in a traffic members of both the disease and the control groups are then inter- a basis of comparison by which the disease group is assessed. The accident. This second group is known as the control group and forms in order to see if any particular characteristic, such as that of viewed and asked various questions. The answers given are analysed `being a heavy cigarette smoker, is found substantially more often among the disease group than among the control group. If positive results of this nature are obtained, then there is at least a all apparently free from disease, are interviewed and asked questions statistical association between the disease and the characteristic concerned. By terming it a'"statistical association" we suspend ,)udgement about the nature of the association: we mean only that a real association of some kind exists between the disease and the characteristic. The second or prospective type of epidemiological study is rather different. In prospective studies, a large number of people, ~2_
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1 1: Aliout the subjects which •are being investigated. It is then 'necessary toywait a number of years, perhaps 10 for example. At :.,;. . " the end of this period, having kept track of all the people who ~'replied as far as possible, information is sought about the causes of death of those who have died. The results are then analysed, very much as in the retrospective type of study, in order to see if those'who have died from, say, lung cancer possessed certain -characteristics substantially more often than those who had died of other diseases. After the end of the war, the Medical Research Council had become concerned about the rapid increase in deaths from lung cancer in this country. In 1947 they planned a large scale investigation to determine whether patients with lung cancer differed materially from other persons in smoking habits or in exposure to atmQspheric pollutfon. This was a retrospective type of study, and a preliminary" : 'report by the two statisticians directing the study (Dr. Richard ." Doll and Sir Austin Bradford Hill) was published in 1950. The study was based upon interviews carried out with patients in hospitals in Greater London, Bristol, Cambridge, Leeds and Newcastle. Altogether, t' - . . , . , . . ~y~ over 4,000 patients were interviewed, of whom Just under 1500 had c ,•`•.r~ lung cancer. Doll and Hill concluded that "there is a real association .between carcinoma of the lung and smoking" and "that smoking is a factor, and an important factor, in the production of carcinoma of the lung". This was the first time that the association between •. i:'.. smoking and lung cancer had been brought to public attention in this country. Two years later, in 1952, the final report of this enquiry was published. Doll and Hill claimed that the results confirmed their._earlier conclusion " that the association between smoking and carcinoma of the lung is real". The retrospective type of study is open to certain criticisms. The most obvious is that people who know or suspect that they have lung cancer may not give true answers when questioned about their smoking habits. I will refer to these criticisms and their validity later. But in consequence of the possible defects of the retrospective type of study, the Medical Research Council started a prospective type of investigation in October 1951. Doll and Hill wrote to some 3 ; •r__.~ . ~~~'~~•'
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rJ i Yy 'F"nrr't ~' . 1e 6i0;00Q men and women on the British Medical Register who were _~~ .. ...--~ r.~-y.;,:.~• resident in the U.K, and asked them for certain broad information 41 ar•~~: ~;; . •,.: _.;..~ .- . . . - . .. . . . .h. 'about their smoking habits. Over 40,000 sent replies that were sufficiently complete to be used. By the end of 10 years about 5,000 of the 40,000 had died. Doll and Hill analysed the results in great detail and the key figures of this study have been given in table 1. Assuming for the moment that the figures in table 1 are valid, they lead to certain conclusions. ,; •, _ _ . First, lung cancer death rates show a very rapid rise as the number of cigarettes smoked daily increases.. As you will see, the ky man smoking 25 or more cigarettes a day has over 30 times the chance of the non-smoker of dieing of lung cancer. For men smoking 35 or .more cigarettes a day, the figure is 45 times. The lung cancer death rate of non-smokers is so low that smokers provide about 90% of all male deaths from lung cancer. This, therefore, leaves very little room for a major contribution to lung cancer by air pollution. Further, there is no level of cigarette smoking that is free from increased risk of lung cancer. Even the smokers of 1- 4 cigarettes a day (the figures are not shown in table 1) have several times the ,, - lung cancer death rate of non-smokers: There is a broadly similar pattern of statistical association between smoking and bronchitis, also shown in table 1, but the bronchitis death rates are only about half the lung cancer rates. It is necessary to remember, however, that perhaps half the men ,and women who suffer from chronic bronchitis are shown on their death certificates as having died from some cause other than bronchitis. To put it bluntly, bronchitis cripples many more than it kills. The last of the three important diseases statistically associated with smoking is coronary thrombosis. The essence of coronary thrombosis is that one of the coronary arteries of the heart is blocked by a thrombus or clot, cutting off the blood supply to part of the heart muscle. If it is an important artery, the heart will stop pumping blood through the body and the person will die. .~•"'"' ,~~~F 'e 47 t'!r' X:. a ax; r"%: ,~r;5a`:•: ~'
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Criticisms of the Statistical Evidence ,,. ~~i :,y,~ •: As I have said, the core of the present situation is contained in table 1. Let us now see if we can show that these figures have German philosopher called von Hartmann used the theory of probability real validity. All of you have heard it said many times that you can prove anything by statistics. As if to illustrate this, a 19th century to prove that there are 59.06 chances in 100 that God exists. I hope least, statistics can never decide the nature of an association being able to prove anything by statistics, it might be nearer the truth to say that you can never prove anything by.statistics. At the recording angel duly noted that .06. But in fact, so far from between two statistically associatdd factors. 1 are invalid, many people, including myself, have squeezed the last In seeking to prove that statistics of the type listed in table .ounce of intellectual questioning from their brains. Fame certainly awaited anyone who could conclusively refute the claim that smoking Depending on how they are classified, I think I could make a caused lung cancer. list of perhaps 50 criticisms that have been made of the epidemiologi- their diagnosis and this led them to over-state the amounts (1) In some studies, patients with lung cancer knew or suspected cal data. The following are just a few of the criticisms: The control groups were often hospital patisnts. Many would be off smoking and this led them to under-state the amounts they they smoked. No one can really know how much he smoked in the past and the information which the interviewers recorded was little better than guesses. had previously smoked. (4) Diagnosis of lung cancer by general practitioners is subject to frequent errors. (5) The average man smokes less than twice the number of cigarettes per day smoked by the average women yet there are five times as many male as female deaths from lung cancer in England and Wales. ,
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.than men whereas lung cancer increased faster in Doll and Hill failed to find a general association in women. inhaling and lung cancer, which they ought to have . smoking really caused lung cancer. (8) People who emigrated from Britain to South Africa or U.B.A. smoked more in their new country, where cigarettes were cheaper, and yet they had Lower lung cancer rates than men who continued to live in Britain. Americans smoke many more cigarettes per head than Britons but I could go on for a long time listing the criticisms that have have a much lower lung cancer rate. been made, but you would find it very tiresome if I was to outline and answer each criticism. I propose therefore to express only two general points: 1. 'The first point is that, as I have mentioned, there have been .cancer and smoking which were found in the retrospective studies spective. Now, you can say that the associations between lung two types of epidemiological studies - retrospective and pro- were due to one or more of the following facts - that the not often true), that the control patients were not an adequate I patients or interviewers knew the diagnosis (although this was -among light smokers in the disease group and/or among heavy match for the disease group, that there was excessive bias to special groups, and particularly to those who volunteered for inclusion in the study. Many British doctors did not participate in the Doll and Hill prospective study. This almost prospective studies had certain imperfections. They were limited not possibly have been present in the prospective studies and so could not account for the association between smoking and lung cancer found in the prospective studies. Of course, the then you are forced to admit that, because of the very different procedure adopted in the prospective studies, these biasses could results of the retrospective studies to biasses of these kinds, much they smoked, say, 10 years ago. If you attribute the smokers in the control group, that people can't remember how - 7 - I
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, ~'~f~.,A%`•:~+ sy certainlymeans that the death rates found in the study would not be, representative of the population as a whole, and perhaps not even be representative of all doctors. But this would not mean that the statistical association between smoking and lung cancer found in the study was invalid, unless it had happened that the non-volunteers were a group where non- smoking and light smoking were highly associated with lung cancer and heavy smoking was associated with freedom from lung cancer. An inverse association of this natureso that over participants and non-participants combined there was no real association, is so improbable that it can be dismissed. (2) The second point is this. Of course, there were inaccuracies in reporting past smoking habits, in diagnosing causes of death, and so on. But when these errors are largely random or fortuitious, they do not invalidate the positive findings of a study. What they do, in fact, is to reduce the apparent magnitude of such associations as do exist. If errors of this nature hadn't occurred, men smoking 25 or more cigarettes a day might have been found to have not 30 times but perhaps 50 or 60 times the lung cancer death rate of non-smokers, and those smoking 35 or more cigarettes a day not 45 times but perhaps 70 or 80 times the rate of non-smokers. I should perhaps add something about the associations between inhaling and lung cancer. Doll and Hill, in their first study, failed to find in association between inhaling and lung cancer. The late Sir Ronald Fisher made great critical play with this particular finding. In later studies, however, In several countries, including Britain, an association between inhaling and lung cancer was found at lower levels of cigarette smoking but not at higher levels. This was a peculiar result, but I believe that it-was due to a failure to adjust the figures, as should have been done, ior differences in the average ages of the different groups. When this has been done, a general association between inhaling and lung cancer has been found, as in recent studies in U.S.A. and Canada. Practically all statisticians who have given thought to the matter - I can think of only two or three exceptions - accept that 7;. .,~,,..,. the statistical association
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: ~r...:. between smoking and lung cancer has been adequately established as really existing. The same applies to the statistical associations of smoking with bronchitis and coronary thrombosis. x•"`; This,of course, does not mean that smoking necessarily causes lung cancer, bronchitis or coronary thrombosis. Statistics can not decide the nature of an association, which is an'entirely :.•,~` °different matter. Naturally, the statisticians could be wrong -in their assessment of the validity of the statistical associations between smoking and lung cancer, bronchitisand coronary thrombosis. Improbable things do happen. An eminei-t 'doctor told me recently that, at his hospital newspaper shop, he had picked up a copy of Playboy magazine. As he said to ments". ri; t
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The Nature of the Statistical Associations between Smoking and the Three Diseases If you accept the view of almost all statisticians that the ~ statistical associations between smoking and lung cancer, bronchitis and coronary thrombosis are real and not spurious ass6ciations, you cannot duck the next set of questions. These are: what is the nature of each of these assoications: does it mean that smoking causes the associated disease? You have, in fact, only two pos- sibilities, which are not mutpally exclusive. Both could be true,.. The two possibilities are these. Firstly, that smoking causes the disease. Theoretically:there is also the possibility that the disease causes smoking. It is, however, so difficult to believe that a disease manifested at age 60 existed undiagnosed at age lQ and caused a man to start smoking at 15, that I propose to dis- regard this possibility. The second possibility therefore is that smoking and the disease are associated because they each have a real association with some third common factor. Since the common factor concept is extremely important, I .should like to give you a fairly clear example of it. There is a real association between divorce and death from coronary thrombosis. Men and women with a high divorce rate have a significantly high death rate from coronary thrombosis. Death from coronary thrombosis obviously does not lead to a divorce suit and it is unlikely that divorce of itself causes formation of a thrombus; The most probable explanation of the association between divorce and coronary throm- bosis is that people of a certain type live in a way which causes them to have a higher than average divorce rate and a higher than average incidence of coronary thrombosis. The common factor is the type of person. Now in examining the nature of the statistical associations between smoking and lung cancer, bronchitis and coronary thrombosis, I think the oourse of the argument may be clearer if we deal with the three diseases in the reverse order. The figures for coronary thrombosis in table 1 have two features. First, there is a tendency for the death rates to increase from non-smokers (331) to light cigarette-only smokers

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