Tobacco Documents Online

.1; ~n &a ,IZ CONFIDENT/AL . CONFIDENTIAL TO: Mr. C. H. Judge FROM: A. W. Spears MEMORANDUM June 24, 1974 ' Before attempting to discuss CTR, a brief review of the organiza- tions contributing to research into tobacco and health seems to be appropriate. Perhaps the simplest way to review the subject is to list the organizations and/or category of organization and general ' areas of research which they are pursuing. 1. Harvard Project - effect of smoke on host genetics and lung function; especially, lung defense mechanisms as mediators of bronchitis and emphysema. 2. Washington University - early detection of cancer by immunological methods and function of the immune system in tumor regression and/or prevention. 3. UCLA - macrophage morphology and function differences between smokers and nonsmokers. Cancer immunology, early diagnosis th rough cell culture methods and cancer chemotherapy. 4. Chemical Comoanies - development of tobacco substitutes using chemical and bioassay methods to indicate differences from tobacco. Some human experiments relating to bronchitis are being conducted. 5. Filter Com anies - development of filters which alter composition o tobacco smoke. Total particulate reduction, vapor phase reduction and reduction of carbon oxides and oxides of nitrogen. by individual companies in house. The aim would be hiqhl 7. Tobacco Research Council - Harrogate Laboratories have been sold, but research on inhalation and cellular effects of smoke continue under contract. Also, it would appear that some results of Harrogate studies are being pursued directly product orientated. PLAINTIFF'S EXHIBIT tay .aL n..n uo.. usnv co , ~ C T R I H N 02' 8 4 15

; N.r, C. H. Judge - 2 - June 24, 1974 A CONFIDENTIAl. 8. University of Kentucky - broad spectrum of chemical and bioassay development programs. Epidemiology into smoke dose obtained by smokers who enter hospital and those that do not. . Primary emphasis seems to be tumorigenesis and chronic pulmonary disease. Program does include agronomical aspects. 9. USDA - program is concentrated on new varieties, curing process, etc. as means of manipulating tobacco. Program utilizes NCI bioassay systems and chemical analysis of smoke. 10. State A riculture Research - program relates to pesticide residues and breeding for low tar and nicotine. 11. Tobacco Sheet Manufacturers - attempting to make tobacco sheets with improved bioassay results. Utilizing NCX and German Institute for bioassay. 12. NCI and NHLI - programs relate to development of bioassay system for tobacco smoke. Evaluation of different products by these bioassay procedures is prime part of program. Emphasis is on tumorigenicity, but programs for cardiovascular disease and chronic pulmonary disease are being initiated. 13. Ad Hoc Committee - most research is epidemiological in nature. Program is primarily aimed at seeking alternate hypothesis of disease causation. 14. CTR - epidemiology, bioassay development, genetics, primarily aimed at tumorigenesis and chronic pulmonary disease, but some activity in cardiovascular disease and smoking motivation. Exclusive of the CTR program, the total annual research fiunding of the listed organizations is on the order of 25 million dollars directly related to smoking and health. Additionally, the federal government is spending on the order of 700 million in 'the general disease areas of cancer, chronic pulmonary disease and cardiovascular disease. Clearly, CTR is conducting research in a highly competitive area, and the programs must be well con- ceived and targeted to avoid unwanted duplication and produce significant results. Sometime ago (1970), the CTR program was evaluated by the Research Directors. At that time, it was felt that the desired aims of the CTR program could be stated as: 1. To define the effects of cigarette smoke on ~ F+ the human system. a ?J 2. To conceptualize and explore other hypotheses Lri relative to the smoking and health question Q= by epidemiological and other appropriate ~ methods. - CTR HN 028460

;• , Mr. C. H. Judge - 3 - June 24, 1974 " CONFIDENT/AL 3. To define motivational mechanisms of smoking, using laboratory animal models as well as human populations. .,. _ . ..-.--. .. . . .. _. ... .._..-- --- . _ . .... . . Following the Harvard funding, B& W suggested that CTR be reorganized and redirected. Their suggestion was basically to expand efforts on the motivational aspects of smoking and to become supportive of Harvard in other areas of research. -They also proposed that the scientific director of CTR be supported by an advisory board and specialized staff members. They proposed a working group for overall coordination consisting of Harvard Scientific Directors, CTR Scientific Directors and industry representatives. -- - •..From what has been said to this point,.it.seems obvious that a multitude of research organizations are involved in the area of smoking and health research. Additionally, U.S. sponsored research into the disease areas associated with smoking are two orders of magnitude above industry spending. Previous suggestions for narrower research aims of CTR have been reflected in their recent program, but overall coordi- nation of industry sponsored research has not been achieved. • It is also apparent that coordination or at least planning information must be obtained from as many as a dozen organiza- tions if duplication is to be avoided and intelligent planning of short and long range objectives are to be accomplished. Also, it is apparent that numerous organizations are newly involved in chemically and biologically based research toward product modification. The most obvious of these in the U.S. are NCI, the USDA and The University of Kentucky. Historically, the joint industry funded smoking and health research programs have not been selected against specific scientific goals, but rather for various purposes such as public relations, political relations, position for litigation, etc. Thus, it seems obvious that reviews of such programs for scientific relevance and merit in the smoking and health field are not likely to produce high ratings. In general, these programs have provided some buffer to public and po li tical attack of the industry, as well as background for litigious strategy. However, the public and political attitude toward ~ smoking has seriously decayed with respect to the tobacco industry, and scientific and political attack has become intense, with efforts at forced product modification underway. Thus, we see the litigation threat of much lesser importance than that of legislative and public acceptance of cigarette smoking. This suggests that goals should be defined more on the basis of scientific aspects, public relations and the programs leading to such goals coordinated more by business apd scientific management. CT- HN 028461

r. C. ii . J:,dge - 4 - June 24, 1974 : ": CGNF(QENriuL We see no way to coordinate without an organization and responsibility to coordinate. The writer believes that only two mechanisms exist for this coordination: (1) a working committee of industry representatives and (2) appointment of one individual for that purpose, with overall program and fiscal responsibility. In the past, and currently, the Committee approach is in effect being used (Committee of Council). However,. representatives of the Committee generally lack the background to bring about scientific coordination and the time to bring about management coordination. It is suggested that CTR be combined with the Tobacco Insti- tute adr.~inistratively, and that an industry cor,raittee along with the staff of the Institute and CTR be designated to help define programs. It is further suggested that the programs at Harvard and Washington University be brought under the same committee, and the Scientific Director of CTR. In addition to providing structure for coordination, we believe that more efficient use of information for public relations and legislative activities is to be gained and reductions in administrative and legal fees can be effected. In looking specifically at the CTR program on a financial basis, as shown below one is struck by the fact that approximately 51% of the budget is associated with cancer related studies. Certainly, one would like an analysis of how much of this work is distinct from the 500 million being expended by NCI and the overall and specific objectives of the CTR research in this area. Another 18% is being expended in the area of lung and pulmonary disease. Again, what are the objectives, and how do they relate to Harvard and all other organizations, particularly Harrogate? Approximately 11% of the budget is associated with cardiovascular research, and of this only 44%, or 5% of the total budget, is directed at arteriosclerosis. Approximately 3.5% of the budget is devoted to motivational research, and 5.6% in epidemiology covering the three major disease areas. A miscellaneous category appears to be generally supportive of the other activities, and represents 11% of the budget. From a review of the individual projects under the cancer heading, one can reasonably describe the experimental objectives. C 1. Investigate the factors, AMH, immune competence,strain, F+ viral infection, Vitamin A, etc. as mediators of the carcinogenic ~ response to chemicals in the small animals. `~ C.~ ~ . ~ - .. ,.... ~ . CTR H~~ 02~~~~

i . + Mr. C. H. Judge - 5 - June 24, 1974 CUNFIBENTINL 2. Develop hardware and facilities for long term chronic smoke inhalation studies with a tumorigenic end point. 3. Determine tumorigenic activity of smoke fractions. _ 4. Determine if reported environmental carcinogens interact with tobacco smoke. - 5. Develop new short term bioassay systems for carcinogenesis. - A review of the individual projects under lung and pulmonary studies indicates that the objectives are diffuse compared to cancer. 1. Determine effect of smoke by chronic inhalation in mice. 2. Explore various facets of lung metabolism, defense mechanisms, etc. COPY q CTR HN 02-84631