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q ,= % rl ( I CANCER PROGRA OBJEC FIVE 1 National Cancel" Plan To Reduce th~ Effectiveness of External Agents in Increasing tne Probablhtles of Development of Cancers in Existing Individuals or in Individuals of Sub- seauent Generatmns. or "To Prevent Cancer i~ Humans by Removing Causative Factors =tom the Environment ot by Reducing Their Effects U.S. Department of ltealtb, Educa,wl., and Wel~re Natio~Tal b~szitutes of Ilealtb / National Cancer Institute t~ ¢o .~. ~l ,~

TArSi E OF' COtITEqTS OBJECT I V_E I ~APTER KEY C~qCER ~ROGRA~ OBJECTIVES P.~IEL HEMBE2S PRE~4BLE I. INTRODUCTION II. RARRATIVE SU~RY OF APPROACHES I. Approach I 2. Approach 2 3. Approach 3 .4. Approach 4 III. COPICLUSI ONS ( PAGE 1i iii iv I-I 2-I 2-I 2-6 2-8 2-13 3-I C,l O~ AKA? OtVAL CANCE*~ pLAN ---- I

C .}~EY C~ICER PDDGRAI4 OBJECTIVES Objective l: Objmctive 2: Objectiv6 3: Objective 4: Objec~ive S: Objective 6: Objective 7: TO Reduce the Effectiveness of External Agents in Increas- ing thb Probabilities of DeveIDpment of Cancers in Zxlstlng lhdividuals or in Individuals Of Subsequent Generations. TO Modify IndivlduaTs {e.g,, by Vaccination) to ~crease the Likeliilood of Cancer DEvelb "on% both in th~ Current Generatie~ and Subseouent Offsbr~ng. TO Prevent Conversions of Cells to these Capable of Farming Cancers C1.e., Block, or Interfere w1:n the Pro×imate Stepj mr Steps, Involved in ~onverslen zo Cells Capable of Forming Cancers>. TO Prevent Tumor Establishment from Cells AlreaDy Capable of Forming Cancers, e.g., Transformed Ceils Cells Consti- Outing Precancerous Tissues aria Cell5 from Pr~marjTumors that LoDge EIsew~ere in ~ne Oo~y in a Metastatic State, Either Active or Dormant. TO Achieve an Accurate Assessment of the Presence, Extent and Probable Course of Cancer Risks in Poaulation Groups {Including Attention ~o Precancerous Lesions) and of Can- cer~ im Individuals Alone [Dlag~osis) aria in Groubs {Detection) ~s an Aid t~ Prevention, Cure or Prognosis. To Cure as Many Patients as Possibl( and to Maintain Maximum Control of the Cancerous Process in Patients noz Cured. TO Restore Patients with Residual Deficits as a Conseauence of Their Disease or Treatment to as Nearly a Norma] Func- tloninc State as Possible. 7~ ~T #~A fi~N~L CANCE~ PLAN

'" C C pAnEL ME ',3ERS Harold P, RUSCH, M.D. - Dhairman Director, McArdle Laboratory for Cancer Research University of Disconsin Nedical School Madison, Wisconsin 53700 Paul KOTIN, M.D. Dean of the Medical School Temple University Medical School 3420 North Broad Street Philadelphia, Pennsylvania 19140 Joseph L. MELNICK, Ph.D. Professor and CDairman, Department of Virology Baylor College of Medicine IDOO Moursand Avenue Houston, Texas 72025 James A. MILDER, Ph. D, Professor of Ontology MoArdle Laboratory for Cancer Research University of Wisconsin Medical School Madison, Wisconsin 53706 Norton NELSON, Ph.D. Director, Institute of Environmental Medicine NYW Medical Center 550 First Avenue New York, New York lODl6 Ernest L. WYNDER, M,D. President, American Dealth Foundation East End Avenue New York, New York lO021 Helen H. BALDWIN, M.S.-Rappor~eur McArdle Laboratory for Cancer Research University of Wisconsin Medical School Madison, Wisconsin 53706 On C~ 6q NA TIONAL CANCCR pLAN -- iI~

PREN'~ LE There i~ enough knowledge presently available which can be applied immediately to prevent the occurrence of cancer in thousands of A~:erican citizens. Some of tile progran,s which lend themselves Pc immediate action are listed in the report of Objective ]. However, the total aim of Ob- jective I cannot be attained merely through the ~pplication of existing information. Inslead it ivill require vastly greater knowledge of fund- amental biology and of basic aspects of the cancer process• Hence, two approaches are required: {a) the exploitation of present leads by the coordinated programs of the National Cancer Plan and {b) the continued support of individual investigators who develop projects and infornlaticn of high scientific value for understanding and ultimately controllinB cancer, Because of the need for improvenent i~ fundamental knowledge, approaches to the major objectives should provid: balanced covenage of (a) basic research, (b) preclinical investigations in animal model systems, and (c) clinical studies in human subjects• The investment In resources should be allocated with a view t~ards balanced support of thes~ three categories of research activity. To achieve fullest exploitation of resources and research capability, an expanded number of scientists, institutions and organizations must be enlisted in the National Cancer Plan, and their efforts must be appro- priately coordinated. This will require major expansion of (a) grants, contracts and other mechanisms of funding; (b) training and recruitn;ent of large numbers and different types of professional personnel, and (c) highly integrated, overall planning and program management• It is urged that immediate steps be taken (a) to increase the training opportunities in cellular and molecular biology and virology, and in cancer biology, virology, immunology, and epidemiology~ and (b) to offer large numbers of Career Cancer Investigatorships to outstanding scien- tists performing laboratory or clinical research. The Career Cancer In- vestigatorships should be awarded for B-year periods with indefinite g- year renewals as long as the investigator remains productive (as determined by a National Review Committee)• To enable maximal utilization of research data and informed decision- r~ making, adequate dissemination of research findings ~sill be required. lhis means improvement in both the communication and the integration of Infomnation. To this end it is essential that the involvement of the scientific ten.unity in the planning and direction of the National Can- cer Program be strengthened, Involvement of the scientific community in the National Cancer Plaa will require continuity and coordination of its participation. TO enhance #.~ the success of the Approaches Planning Sessions, it is recommended that reports of the subsequent Project Area Plannlnq Sessinns be presented t~ the original participants of the Approaches Planning Sessions for further discussion and refinement, in order to provide continuity and coordlna- tion of planning efforts. There is a need for sustained invo]vement of NA TtONAL CANCER ~LA N --

< Objective I Preamble such an advisory gPoup OF senior cancer investigators and scientific managers, drawn from the scientific community at large and operating under a.systEm ~.shich provides a gradual rotation of membership. Such an advisory group, having the size and scope of the Approaclles Planning Groups, could be effectively complemented by ad hoc groups of censultants representing a far larger cross-section of the scientific community. H~'~ever, in order to maintain long-range continuity of involvement, it is necessary that the principal advisory group not be replaced by ad hoc groups, whose involvement would be lindted in time and scope. C~ C~ C~ C,I C~ #4A r¢O~'A L CANC£,~ pLA,V V

" C E i , I i F I. INTRODUCTION This program aims to prevent cancer in humans by removing factors frDm the environment which are responsible for the disease or by reducing their effects on humans. It is based upon scientifically sound convictions: l. Environmental factors are of major importance in causin~ cancer in humans. Epidemio]ogical studies in COm~ination with tests ~s have identified factors in environments that are im- portant in the causation and development of human cdncers. 2. [llmination or reduction of hazardous factors from the environ- ment can prevent human cancer. Elimination of these knoun identi- fiab]e f~ctors from the environment is possible and v~ould prevent the development of cancer in persons now living and in their off- spring• ~ 3. Feasible means exist or can be developed to identify and eliminate such factnrs• i,m:ediate steps should be taken to eliminate or greatly reduce from the environment any substance now knovtn to be ~ Carcinogenic to humans or to animals• 4. The introduction of as ,yet unknol:n, man-made carcino~ hazards into the environnlen~ can be controlled. Present-day exposure to nmst of the kr~olIn chemical and radiation carcinogens has resulted directly or indirectly from technological developments of the past hundred years (e.g., dye industry, atonllc fission and fusion, petro- chemical developments). Since the introduction of new products NA TION,~L CANCE f~ pLAN,

• C C ! , ' Objective 1 Introduction continues at an ever increasing pace, the probability of generating new carcinogeric hazards requires greater scrutiny and testing of new industrial processes and products before they are introduced in the environment. lon term su port of carefully designed studies will make possible 5. ~'fl~cdtqon of currently uilknolm factors respon~Ib-l~ hg[[Id~l cancer~b tn~ understaldin_ ~ of hol,i such factors cause can- the reduct on of thelr iT")aCt on exposed persons• Con- tinuing long-term epiaen,ioioglcal studies and a~ are essential to identify othm- factors already in the environment Which present earcinogonic hazdrds to man. ~hese studies must be supplemented by co~iparative studies of the relationship bet.een carcinogenic activity in tests on animals and the threat to man, and by studies of the interaction of multiple environmental and internal factors on humans and in model animal systems, Past ex- perience indicates thet such studies will make possible the elimi- nation of additional carcinogenic h~zards or will provide means '-by which their effect can be minimized. • The following amplification of these convictions underlies the proposed program for prevention of human cancer and justifies the belief that ~e now have sufficient information to act immediatel~ anO prevent a siS- nificant pertlon of human c~icer. om r~ lea T~OIVA L CAhYCEFt pLAN - I-2

C II. NARP~TIVE SUMMARY OF APPROACHES Approach I..The Application of Present Knowledge to Prevent Cancer in Humans ~ Socia] Action. Modern eDidemiological studies indicate clear1: ~naz several human cancers have significant environmental factors in their etiology. In particular, the ca£Jsative l~k hetl,,een smohin~ of cioarrttps ~nd the incidence of lung cancer is unassailable• lhe smokihg of cigarettes plays a causative role in approximately one fourth of tlTe cases of cancer in the American males• in 197D about 5O,oog individuals in the United States died from cancers ~shlch vleuld not have occurred if they had rot smoked cigarettes. For this reason the most effective, action possible today to decrease the incidence of cancer of the lung i~ to reduce to a minimum the inhalation of tobacco smoke. We can anticipate that if cigarette smoking ivere halted today, rather than continuing at its present rate, approximately one half million lives would be saved ~ver f~he next ten yPdrs, For these reasons ~ assign the highest priority to a series of actions designed to reduce the smoking of ciga- rettes by the American public. Additional environmental factors haw been identified ~hich have an undenidble, although smaller, effect on the incidence of cBnrer. There is every reason to act i ~mediately to reduce or eliminate these factors ~.~ from the environment. Che;nicals (polycyclic hydrocarbons) knovm to be carcinogenic tQ man and animals have been identified in the air. Execs-G3 sive exposure to sunlight is knovn to be responsible for most cases of ~in cal}cer. ComposJe~ts of 5mPgmas a ~aterial that collects under the ~ foreskin of uncircuncised Blalesp has been implicated in the etiology of NATIONAL CANCER PLAN -- 2-1 '~1

C Narrative of Approaches Objective ] l penile cancers. The continued therapeutic use of hazardous drugs and hormones, and th~ unwitting ingestion of carcinogenic substances in food and water also may contribute to the present incidence of cancer. Certain irldustrial processes and occupations involve exp~sut'e to aqents {chemicals, dusts, or irradiation) kno~,n to cause cancer, In a~l of these situations reductYon of the exposure, elimination of the agent, and/or protection of the persons exposed must bc undertaken to p~event further needless death and suffering. ~. ~evelop Administrative and ke~|slatlvo Pro~raR~. I. Limit tobacco production and use. While outright prohibition of the production and use of cigarettes is probably not prac- ticable, the Federal government must take direct and primary responsibility for a rigorous control programwith sustained surveillance of established standards. The following six actions could greatly reduce the incentives toward and danger ~f smoking, a. Reduce the economic incentives for growing tobacco. b. Extend the limitations on advertlsing, and promotion of tobacco products, especially cigarettes, Equal space requil-ements of all advertising, in parallel with equal- time requirements on radio and televisions, could b~ explored. Control of sales locations {e,g., vending machines), perhaps by licensing, to render cigarettes less available and prominent to susceptible persons. should be considered. Increased taxi~Ig of tobacco products should also be considered. c. prohibit smoking in public areas. The exposure of non- smokers to the side-stream smoke of user's cigarettes represents an unacceptable trespass on individual rights. d. Establish more stringent limits on tar and nicotine con- tent of cigarettes. Standards for the effectiveness Of filters, for low~ nonaddictive levels of nicotine, as well as for maximal levels of "tar" components, are needed to protect present smokers. Continuous monitoring of the product, review and up-grading of the standards, and ex- ¢lusiQn from the market of foreign products which fail to meet the sta~dard~, should be included in the legi~laticn. Proposals considered currently by the Canadian Government should be examined. e, Seek positive financial incentives through tax benefits. Federal medical aids, and other means should be sought for ~On-s~okers. These can be of greatest value if directed toward the younger, IO to 18 year-old, group. While "policing" of smoking habits is impossible, the health costs to the nation of continued cigarette use Justify positive encouragement to stop smoking. Present ~ed~rally-supported encouragement to smoke, such as tax- f~ee. low cost cigarettes available to the Armed Fo~ces Gm @0 G~ ¢m :b