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RJ Reynolds

A History of Cancer Control in the United States 1946 (460000)-1971 (710000) Book One. A History of Scientific and Technical Advances in Cancer Control.

Date: 09 Jan 1977
Length: 30 pages
503110486-503110515
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REPORT
Referenced Document
Smoking and Lung Cancer: A Statement of the Public Health Service, by Burney L, Journal of the American Medical Assn (590000). Surgeon General's Report on Smoking and Health. Federal Communications Act. Public Health Cigarette Smoking Act. Wynder Graham S
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Minnesota
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Rogers
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Texas
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Disclosure
Mangini
Court
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19960800
Box
Rjr2026
Author
Breslow, L.
Univ, O.F. Ca Los Angeles School, O.F. Pu
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Pa
Public Issues
Osmon He
Dir Public Issues
Named Person
Nci
Ti
Breslow, L.
Nih
Public Health Service
Herblock
Ochsner, A.
Wa Univ
Dock, G.
Tulane Univ
Miller
Debakery, M.
Shimkin, M.
Wynder, E.
Oaglin
Hammond, E.C.
Horn, D.
Doll, Hill
Dorn
Surgeon General
Burney, L.
Kennedy
Terry, L.
Royal College, O.F. Physicians
Ribicoff
Celebreeze, A.
Surgeon Generals Advisory Comm, O.N. S
Dixon, P.R.
Univ, O.F. Ca Los Angeles School, O.F. Pu
Moss, F.
Elman, P.
Clements, E.C.
Fcc
Natl Clearinghouse, O.N. Smoking & Hea
Banzhaf, J. III
Tuberculosis Assn
Talman, W.
Center For Disease Control
Agran, L.
Graham, E.
Us Congress
Usda
Acs
Ftc
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Brand
Marlboro
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zsk68d00

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rctiraatel)' 70 i~rcCnt }:ig,ur that for nLn crK):crs7 l,uig cancers, and cancers of other sites, accounted for a disproportionately high nwnber of the excess deaths. In all of the studies, as the amount of cigarette consumption increased, so did total mortality rates. In terms of public health policy, an especially significant finding in the Hammond-Horn investigation was that the mortality risk from smoking decreased as the number of years of smoking cessation increased. (24) By the mid-1950s, dispute among scientists investigating the cigarette-cancer connection was waning. A consensus on the causal con- nection was clearly taking shape. The cigarette, first described as possibly "associated" with lung cancer and, later, as a "factor" in the disease, was now described with increasing confidence as the over- riding cause of the twentieth century lung cancer epidemic. In fact, in this period of rapidly mounting scientific evidence, Surgeon General ' Leroy Burney, urged by NCI's Dr. Michael Shimkin, had a statement pre- pared in 1957 concerning the cigarette-lung cancer connection. For well over 2 years, Dr. Burney's statement remained mired in the federal health bureaucracy, subject to countless revisions and clearances. (See Book Two, Chapter 5.) It wasn't until November, 1959, that the statement was finally published--as an article in the Journal of the American Medical Associa- tion. (25) Entitled "Smoking and Lung Cancer: A Statement of the Public Health Service," the article declared: 'The weight of evidence ... implicates smoking as the principal etiological factor in the increasing incidence of lung cancer." (26) Interestingly, the Surgeon General's statement received little publicity; and its overall impact on public policy was negligible. 175
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.In 1962, the Royal College of F'hysiciwis in Loi:don stated their conclusion on smoking and cancer causation in the plainest of terms: 'The strong statistical association between smoking, especially of cigarettes, and lung cancer is most simply explained on a causal basis." (27) The report of the Royal College of Physicians went on to raise the spectre of a second stage in the lung cancer epidemic--the toll it was yet to take among women. Because women did not develop smoking habits quantitatively comparable to those of men until after World War II, it was hypothesized that the full effect of cigarettes on the female lung cancer rate could not be assessed for some years, in view of the time period ordinarily required before cancer manifests itself. The Surgeon General's Report on Smoking and Health In January, 1964, two years after the Royal College of Physicians' report, the Surgeon General's Advisory ConQnittee on Smoking and Health published what was to become the definitive American statement. (28) In arriviing at its conclusions on the effects of smoking, the committee experts evaluated three kinds of scientific evidence: (1) animal studies in which the effects of smoke, tars, and toxic irritants were measured; (2) clinical and autopsy studies of smokers and non-smoke'rs, such as the Ochsner-DeBakey study; and (3) epidemiological studies, both retrospective and prospective. Second only to its impact on the smoking-health con- troversy, perhaps the most critical contribution of the Advisory Cornnittee's report was to gain lasting acceptance for epidemiology as a bona fide science that could no longer be dismissed as "mere statistics." While epidemiology had been recognized for some time as useful in the study of acute disease, the 1964 Surgeon General's report established epidemiology's 176
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',)L1! 11)' 1l.`r 1e :ly.aL1o;1 01 L Chapter 9 of the Advisory Committee's report was titled simply "Cancer." The chapter's 136 pages consisted of an exhaustive review of the epidemiological evidence not only with respect to tobaccogenic lung cancer, but for other organ sites as well, such as the mouth,.:,, larynx, esophagus, urinary bladder, and stomach; other chapters in the report reviewed epidemiological evidence linking cigarettes to non- neoplastic respiratory diseases, cardiovascular diseases, and other conditions. Dealing directly with the question of ascribing causation based on a statistical association between a factor such as cigarette smoking and a disease such as lung cancer, the Committee wrote: Causal Si 'ficance of the Association. -- As already stated, statistical me s cannot esta lis proo of a causal relation- ship in an association. The causal significance of an association is a matter of judgment which goes beyond any statement of statistical probability. To judge or evaluate the causal r significance of the association between cigarette smoking and lung cancer a number of criteria raust be utilized, no one of which by itself is pathognomonic or a sine ug_a non for judgment. These criteria include: (a) The consistency of the association (b) The strength of the association (c) The specificity of the association (d) The temporal relationship of the association (e) The coherence of the association (29) Fmploying these criteria, the Committee concluded that: 1. Cigarette smoking is causally related to lung cancer in men; the magnitude of the effect of cigarette smoking far outweighs all other factors. The data for women, though less extensive, point in the same direction. 2. The risk of developing lung cancer increases with duration of smoking and the number of cigarettes smoked per day, and is diminished by discontinuing smoking. (30) While making no specific policy proposals, the report went on to call for "remedial action" to reduce the health hazard posed by cigarette smoking. 177
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f Viewed historically, it is now apparent that the report had the remarkable effect of really*settling the scientific issue whether cigarettes indeed caused lung cancer. How was it that this second Surgeon General's report proved so effective when the Burney report- initiated in 1957 and published in 1959--had been so ineffective? Several reasons emerge. First, the passage of time itself was a key factor. Between 1957 and 1964, the findings of some of the large prospective A epidemiologic studies were being published, confirming earlier work, and solidifying the growing scientific consensus on tobaccogenic cancer. Second, in both its design and scope, the 1964 report was a far more impressive document. Fmp.loy3ng a sizeable staff, the Advisory ' Committee took more than a year to exhaustively review virtually all of the evidence at hand regarding the.smoking-health issue generally, and the cigarette-cancer issue specifically. The full document, almost 400 pages long, reflected the,kind of ct..e. that would enable the report to withstand the scrutiny and criticism that would inevitably follow its release. The third reason for the effectiveness of the 1964 report, as compared with the-1959 Burney report, can be attributed to what might be called the managerial factor. From beginriing to end, Surgeon General Luther Terry sought to assure maximum impact of the report's findings--- whatever they might be. The report was not to be his per se, but rather the report of an "expert committee," acknowledged by the President, thereby gaining enormous stature. (31) Dr. Terry selected the 10-member Advisory Committee in a way to virtually guarantee that there would be no subsequent charges of bias. He insisted that no one could be a member of the Advisory Comnittee if he had been publicly identified with any 178
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position on the smoking-health question. (32) ASoreover, he astutely allowed the Tobacco Institute to veto any proposed nominees to the . Advisory Committee. (33) In this way, the Surgeon General managed to bestow upon the Advisory Committee the tobacco industry's implicit en- dorsement as to its objectivity. Throughout the investigation, all meetings and staff work were conducted in a politically protected en- vironment, based at the National Library of Medicine. (34) Dr. Terry forbade the Corrmittee members to speak to politicians or the press. In exchange, he secured assurances from President Kennedy and HEW Secretary Ribicoff (and, later, Anthony Celebrezze) that the Committee could carry out its work insulated from any political influence. (35) Consistent with these precautions, there were no leaks or any other disclosures to sap the final report of its desired impact. Finally, when Dr. Terry released the report on January 11, 1964, it was with the utmost fanfare--a carefully staged press conference to carry the message to the American public. (36) In the Aftermath of the Surgeon General's Re2rt, 1964-65 With the release of the Advisory Committee's report on January 11, 1964, the purely scientific phase of the cigarette controversy had largely run its course. Almost immediately, the controversy shifted to the political realm--a clash between public health considerations on the one hand and private economic interests on the other. The stakes were evidentt from the outset. The mere issuance of the Surgeon General's report, coupled with the attendant publicity, produced a short-run, one-month decline in cigarette sales of more than 15 percent. (37) But more sig- nificant than this temporary impact was the fact that the report's release 179 . . ~ , ~. . ~ :
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signalled the nation's err;)arkation along a twisting pathway in search of an appropriate cigarette policy. It is now clear that at several points along that pathway- -stretching from 1964 to 1971--advocates for the public's health stumbled across the elements of a truly effective program in cancer control education, only to have the Congress inter- vene to block the emerging policy and then redirect it along predictably unproductive lines. In the winter and spring of 1964, there was no requirement that the Congress act in response to the Surgeon General's report. In fact, it is likely that no action at all would have been forthcoming had it not been for the maverick-like conduct of the Federal Trade Commission, 91 particularly its Chairman, Paul Rand Dixon, and commission member, Philip Elman. Citing the Surgeon General's report, and then citing its authority to regulate comnerce so as to eliminate unfair and deceptive trade practices, in a classic document of administrative law, the FTC proposed a trade regulation rule which would have required in every cigarette advertisement (radio, television, billboards, and print media) and on every pack, box, and carton of cigarettes, the prominent in- clusion of one of the following warnings: (1) CAUTIO:V--CIGARETTE SMOKING IS A 1ElLTH HAZARD: The Surgeon General's Advisory Committee on Smoking and Health has found that "cigarette smoking contributes substantially to mortality. from certain specific diseases and to the overall.death rate;" or (2) CAUTION: Cigarette smoking is dangerous to health. It may cause death from cancer and other diseases. (38) The fact that the regulation would have required the labeling of one of these warning statements on every pack, box, and carton of cigarettes was not nearly as signiticant as the requirement that the statement accompany any advertising, including broadcast advertising. A disclosure statement 180
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of the kind proposed by the FTC threatened to destroy the appeal of radio and television advertising, an appeal of such enormous dimensions that the industry was pumping nearly $200 million per year- -four-fifths of its advertising expenditures- -into these media. Faced with the impending FTC actiori, the tobacco lobby, whose principal lobbyist was former Congressman Earle C. Clements (D-Kentucky), turned to the Congress for help. (39) In substantial measure, the industry received all the help it needed with the Federal Cigarette Labeling and Advertising Act of 1965. (40) In this act, Congress blocked the FTC's proposed regulations and required instead that as of January 1, 1966, all cigarette packages, boxes, and cartons sold in the U.S. must bear the statement: "Caution: Cigarette Smoking May be Hazardous to your Health." Beyond this inconspicuous side-panel requirement, the Congress refused to require that the mildly worded warning statement accompany radio and television advertising- -the key to the promotion of cigarette sales. In fact, the labeling act ex- pressly banned the FTC, and any state or local agencies,_from taking any action in this regard for a period of four years. Senator Frank Moss (D-Utah) later lamented that the 1965 legislation effectively sus- pended the entire apparatus of federal and state regulatory authority in exchange for nine innocuous words on the side-panel of cigarette packages. Representative John ;,ioss (D-Calif.) voiced his opposition in these terms: This legislation puts the Federal Government in the position of saying that cigarette smoking constitutes a serious health hazard, but that traditional guardians of public health, the state and local authorities, cannot act to protect their citizens if they believe a warning statement in cigarette advertising would do so. (41) .• 181
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The warning requirement, he said, does little to act as a remedy to curb the cigarette health hazard. . . A more realistic and responsible approach. ..would be to warn the non-smoking consumer of the health hazard before the product is purchased--rather than remind the individual who already smokes and after he has the product in his possession, that it may be harmful to his health. ...We must first concern ourselves with public health and welfare, not legislate to the whims of a special interest. (42) When thq labeling requirements went into effect on January 1, 1966, there was no significant impact on cigarette sales; per capita con- sumption increased slightly in 1966, (43) By way of separate legislation, the Congress took other action in the cigarette field in 1965. As a means of maintaining the staff which had served the Surgeon General's Advisory Committee, the Congress appropriated $2 million to the Public Health Service to establish a ' .~ National Clearinghouse on Smoking and Health. (44) Lodged in the Cancer Control Program in the Division of Chronic Diseases, the Clearinghouse undertook responsibility for gathering and disseminating information on smoking and health including, later on, the preparation and promotion of anti-cigarette media messages. Under the direction of Daniel Horn, who had contributed to the pioneering scientific work on tobaccogenic cancer, the Clearinghouse, tiny as it was, nevertheless represented the only programmatic evidence of a national effort to discourage cigarette smoking. The Banzhaf Decision and CoM essional Re-entry, 1967-71 In mid-1967, a year and a half after the labeling act took effect, a young attorney named John Banzhaf III filed a Fairness Doctrine complaint with the Federal Corrumnications Commission. In his canrplaint, he called upon the FCC to make a finding that cigarette corrmercials per se con- 182
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stituted statements depicting one side of a controversial issue of public importance and that, accordingly, the Federal Comamications Act required the FCC to order stations to provide "equal" time for the pre- sentation of the "other side" of this public controversy. In a land- mark decision, the FCC agreed with much of Banzhaf's argument and re- quired broadcasters to accord a "substantial" amount of air time-- although not "equal" time--to the "other side" of the cigarette con- troversy. (.4S) With this decision, the nation was launched on a three-and-a-half- year experiment in public health education by way of anti-cigarette commercials. Affirmed by the courts in 1968, (46) the FCC action was interpreted to mean that radio and television stations had to provide roughly one free anti-cigarette message for every five pro-cigarette messages. (47) Translated into aggregate terms, this meant that by 1969 and 1970, approximately $40 million per year in broadcast time-- free of charge--was accorded to the American Cancer Society, the Tuberculosis Association, and other non-profit organizations in order to present hard-hitting anti-cigarette messages. It was a unique era in broadcast advertising, giving rise to a host of creative anti-cigarette messages. For example, there were the messages depicting a pleasant scene: people having fun, enjoying life. Then one of the people would light up a cigarette and the voice-over caption would follow: "This is life. .... This cuts it short." Another spot message was a parody of the Marlboro man. A tough-looking, gun-toting cowboy pushed his way into a saloon," inhaling a smoky cigarette. Then he began to cough uncontrollably, and was pushed aside by a clean-cut, non-smoking cowboy. Then the word "cancer" zoomed up on the television screen and the voice-over announcer 183
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said, "Cigarettes--they're killers." Perhaps the most forceful of the anti-cigarette messages on television was the one in which William Talman, the actor who played Hamilton Burger on the Perry Mason series, introduced his family and then revealed that he had lung cancer. He then urged smokers to quit and non-smokers not to start. By the time this particular anti-cigarette message was on the air, William Talman was dead from lung cancer. While the FCC facilitated the era of anti-cigarette messages, it is interesting to note that this novel venture.in public health education had its beginnings in the voluntary sector, not the public sector. Indeed, both in its origin and in its content, the anti-cigarette campaigr_ was r almost exclusively a product of the voluntary sector. And even within that sector, some traditional voluntary health agencies, most notably the American Cancer Society, were unwilling to back the initial Banzhaf complaint. (48) During the years 1967-1970, the Banzhaf decision had a major impact on per capita cigarette consumption. After years of virtually unin- terrupted growth in per capita consumption, there was a slight fall-off in 1967--4280 cigarettes for every U.S. resident 18 years of age and older as compared with 4287 in 1966. (49) In 1968, per capita con- sumption fell again--to 4186 units. (50) In 1969, when monitoring and public pressure was assuring widespread compliance with the Banzhaf decision, anti-cigarette messages were in full swing; and per capita consumption suffered its most severe drop-off, down to 3993 units. (51) In 1970, a further decline was registered, down to 398S cigarettes. (52) (See Figure 1,) . r, 184

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