Tobacco Documents Online

-11- included. There can be no guarantee we will come out clean, but our relationship will encourage them to look beneath the simple associations of smoking with mortality for more fundamental explanations. Their sample is about 4,000 members of through '66. psychological data from their college days is available. The study took more time than expected to get started but the first follow-up questionnaire went out in May of 1987, including a detailed smoking history question. A second questionnaire went out in July of '88; a third will go out this year and follow-up will continue approximately at yearly intervals. I once thought five years after the first follow-up would be sufficient to ascertain the degree, the University of North Carolina classes of 1964 if any, of the study's exonerative potential. I n~ow t_hink it may take nearer ten vears to accumulate enoucth po~t ~ first-response-deaths to make a first estimate f the relative importance of the various possible contributing acto However, we should learn within the next year or two whether the study has identified large average differences between smokers and never smokers; if not, the mortality follow-up is much less likely to be helpful. Last year Bill approved $567,000 over three years to a group headed by Dr. Lindon Eaves of the Genetics Department of the Medical College of Virginia. This is for anothex- mortali dde larcLe- _part of the gample will be twins One reason for our support was that they had acquired a data base, including smoking behavior,

-12- while conducting a passive smoking study for Reynolds. It was plain to me, they were going to use it for a future mortality study of active smoking, even if they had to bear the costs themselves. However, it did not include coffee usage. This was potentially important because two other studies have shown heavy coffee usage has become a risk factor for heart disease. I'm not picking on coffee. I think the explanation is that a certain type, who once would have been a smoker and a heavy coffee drinker has been frightened out of smoking but is still a heavy coffee drinker and still the type that is prone to premature mortality. Another motive for the MCV grant was that its twin content would permit testing the hypothesis that the site and nature of the terminal illness is under stronger genetic control than longevity. Support for this would contribute to the broader proposition that the aggregate determinants of the nature and site of the terminal illness can differ from the determinants of longevity. It would be very helpful to our scientific defense if the ground could be shifted from smoking's strong association with lung cancer to its much more modest association with premature mortality. The weaker association with all-cause mortality is much more in the range of the excess risk that might be attributable instead to the psychosocial factors. Also, the historical trends of all-cause mortality rates are not distorted by the improvements in diagnosing lung cancer --

-13- so you can make legitimate comparisons with smoking trends. We should know in about seven years if this study will be helpful on the mortality question. Possibly another five years will be required to compare the genetic control on mortality with its control over the terminal illness. We also granted Dr. John Thomas of Mehari Medical Oollege, $112,000 to continue a prospective mortality study of black medical students. One particular motive here was to break through Dr. Thomas's conviction that high mortality among blacks is due to a higher prevalence of smoking. Also, I wanted him to put coffee usage into his data base, which he had previously failed to do. A grant for $165,000 that falls outside our mainstream was given to a group headed by Dr. Michael O'She.g-, then a Professor of Pediatrics at Duke. The subject is a study, including smoking habits, of teenagers who had respiratory problems in infancy. It could be helpful to our hypothesis that individuals with lung problems are preferentially likely to obtain satisfaction from smoking. This study is expected to last another year or two. I have saved for last intervention testing, also known as the clinical trial. This is the end game of medical research. In its purest form you randomize a group of subjects into two halves. One half gets the treatment prior research indicates ought to be effective. The other half gets a placebo. The technique has been imperfectly adapted to smoking by giving the treatment group extra advice on giving-up <0,

-14- smoking that the control group does not receive. As you know, smoking has made out rather well so far when the data is analyzed properly. The aggregate reporting to date of all the intervention testing that included smoking cessation advice shows no advantage for the treatment groups in lung cancer or all-cancer mortality, though it does give the treatment groups a minor advantage in all-cause mortality. That cannot be credited entirely to smoking cessation because most of those studies also intervened against blood pressure and cholesterol. Also, we can point out that conventional placebo treatment for the comparison groups has been absent, and additionally raise our point that the trials are biased by the harmful stress placed by the health warnings on those who continue to smoke, and by the placebo effect of smoking cessation. Our funding activity in this area is to support the clinical trial of stress management counseling. Such trials can demonstrate the role of stress in mortality, while avoiding the ethical and practical problems that would arise from a deliberate attempt to add enough additional stress to the lives of subjects to affect their longevity. There have already been results that are far more impressive than the trials th~ncluded smoking cessation advice. A European name 12 as reported 50% mortality rate Grossarth-Maticek reductions for his psychological counseling. He has become a protege of Hans Eysenck. Through Dr Ey~en~~k .c_ - funded some of the follow-up analysis of the Grossarth-Maticek

-15- counseling. The additional publication outlook here is now cloudy because some of the early results were published in minor journals and Dr. Eysenck commented extensively on both the early and the more recent results in Psychology Today, h" s not a tru ademic journal. M~er Friedma of Type A fame, has given what he calls his Type A behavior modification counseling to heart attack survivors, achieving nearly a 50% reduction in subsequent mortality. That project was to be his last. However, we talked him into beginning again, this time with individuals who have not yet had a heart attack. Bill has approved approximately a $5,000,000 commitment to cover the first five years of a study planned for 13 years. Success with subjects who have not already had heart attacks will confirm that the counseling is effective among individuals who have not been frightened into good behavior by their first attack. Also, because we can expect a much_ higher proportion of cancer in this group than in heart attack survivors, the ro ect will provide a chance to docuonclusivelv the role of stress in cancer, __ I think the crying need now is to start another primary prevention study. I believe success here has tremendous potential for us, particularly after the indifferent results of the primary prevention studies employing advice about diet, smoking and exercise. However, the battleship admirals will demand independent replication and government funding is very doubtful because NIH had its fingers burned

-16- by MRFIT. We can't fund another of these large projects unless we are prepared to lift the annual outlays, in my budget, above the present $2 million level. Funding another intervention study could take us to $3 million a year or even $4 million. On that grasping note this presentation concludes. N 0 N C.~ 0 W ~ W ~